[Federal Register Volume 88, Number 247 (Wednesday, December 27, 2023)]
[Notices]
[Pages 89455-89456]
[FR Doc No: 2023-28509]

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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2022-E-2035]

Determination of Regulatory Review Period for Purposes of Patent
Extension; PONVORY

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice.

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SUMMARY: The Food and Drug Administration (FDA or the Agency) has
determined the regulatory review period for PONVORY and is publishing
this notice of that determination as required by law. FDA has made the
determination because of the submission of an application to the
Director of the U.S. Patent and Trademark Office (USPTO), Department of
Commerce, for the extension of a patent which claims that human drug
product.

DATES: Anyone with knowledge that any of the dates as published (see
SUPPLEMENTARY INFORMATION) are incorrect may submit either electronic
or written comments and ask for a redetermination by February 26, 2024.
Furthermore, any interested person may petition FDA for a determination
regarding whether the applicant for extension acted with due diligence
during the regulatory review period by June 24, 2024. See ``Petitions''
in the SUPPLEMENTARY INFORMATION section for more information.

ADDRESSES: You may submit comments as follows. Please note that late,
untimely filed comments will not be considered. The https://www.regulations.gov electronic filing system will accept comments until
11:59 p.m. Eastern Time at the end of February 26, 2024. Comments
received by mail/hand delivery/courier (for written/paper submissions)
will be considered timely if they are received on or before that date.

Electronic Submissions

    Submit electronic comments in the following way:
     Federal eRulemaking Portal: https://www.regulations.gov.
Follow the instructions for submitting comments. Comments submitted
electronically, including attachments, to https://www.regulations.gov
will be posted to the docket unchanged. Because your comment will be
made public, you are solely responsible for ensuring that your comment
does not include any confidential information that you or a third party
may not wish to be posted, such as medical information, your or anyone
else's Social Security number, or confidential business information,
such as a manufacturing process. Please note that if you include your
name, contact information, or other information that identifies you in
the body of your comments, that information will be posted on https://www.regulations.gov.
     If you want to submit a comment with confidential
information that you do not wish to be made available to the public,
submit the comment as a written/paper submission and in the manner
detailed (see ``Written/Paper Submissions'' and ``Instructions'').

Written/Paper Submissions

    Submit written/paper submissions as follows:
     Mail/Hand Delivery/Courier (for written/paper
submissions): Dockets Management Staff (HFA-305), Food and Drug
Administration, 5630 Fishers Lane, Rm. 1061, Rockville, MD 20852.
     For written/paper comments submitted to the Dockets
Management Staff, FDA will post your comment, as well as any
attachments, except for information submitted, marked and identified,
as confidential, if submitted as detailed in ``Instructions.''
    Instructions: All submissions received must include the Docket No.
FDA-2022-E-2035 for ``Determination of Regulatory Review Period for
Purposes of Patent Extension; PONVORY.'' Received comments, those filed
in a timely manner (see ADDRESSES), will be placed in the docket and,
except for those submitted as ``Confidential Submissions,'' publicly
viewable at https://www.regulations.gov or at the Dockets Management
Staff between 9 a.m. and 4 p.m., Monday through Friday,<PHONE_NUMBER>.
     Confidential Submissions--To submit a comment with
confidential information that you do not wish to be made publicly
available, submit your comments only as a written/paper submission. You
should submit two copies total. One copy will include the information
you claim to be confidential with a heading or cover note that states
``THIS DOCUMENT CONTAINS CONFIDENTIAL INFORMATION.'' The Agency will
review this copy, including the claimed confidential information, in
its consideration of comments. The second copy, which will have the
claimed confidential information redacted/blacked out, will be
available for public viewing and posted on https://www.regulations.gov.
Submit both copies to the Dockets Management Staff. If you do not wish
your name and contact information to be made publicly

available, you can provide this information on the cover sheet and not
in the body of your comments and you must identify this information as
``confidential.'' Any information marked as ``confidential'' will not
be disclosed except in accordance with Sec.  10.20 (21 CFR 10.20) and
other applicable disclosure law. For more information about FDA's
posting of comments to public dockets, see 80 FR 56469, September 18,
2015, or access the information at: https://www.govinfo.gov/content/pkg/FR-2015-09-18/pdf/2015-23389.pdf.
    Docket: For access to the docket to read background documents or
the electronic and written/paper comments received, go to https://www.regulations.gov and insert the docket number, found in brackets in
the heading of this document, into the ``Search'' box and follow the
prompts and/or go to the Dockets Management Staff, 5630 Fishers Lane,
Rm. 1061, Rockville, MD 20852,<PHONE_NUMBER>.

FOR FURTHER INFORMATION CONTACT: Beverly Friedman, Office of Regulatory
Policy, Food and Drug Administration, 10903 New Hampshire Ave., Bldg.
51, Rm. 6250, Silver Spring, MD 20993,<PHONE_NUMBER>.

SUPPLEMENTARY INFORMATION:

I. Background

    The Drug Price Competition and Patent Term Restoration Act of 1984
(Pub. L. 98-417) and the Generic Animal Drug and Patent Term
Restoration Act (Pub. L. 100-670) generally provide that a patent may
be extended for a period of up to 5 years so long as the patented item
(human drug or biological product, animal drug product, medical device,
food additive, or color additive) was subject to regulatory review by
FDA before the item was marketed. Under these acts, a product's
regulatory review period forms the basis for determining the amount of
extension an applicant may receive.
    A regulatory review period consists of two periods of time: a
testing phase and an approval phase. For human drug products, the
testing phase begins when the exemption to permit the clinical
investigations of the drug becomes effective and runs until the
approval phase begins. The approval phase starts with the initial
submission of an application to market the human drug product and
continues until FDA grants permission to market the drug product.
Although only a portion of a regulatory review period may count toward
the actual amount of extension that the Director of USPTO may award
(for example, half the testing phase must be subtracted as well as any
time that may have occurred before the patent was issued), FDA's
determination of the length of a regulatory review period for a human
drug product will include all of the testing phase and approval phase
as specified in 35 U.S.C. 156(g)(1)(B).
    FDA has approved for marketing the human drug product, PONVORY
(ponesimod). PONVORY is indicated for the treatment of relapsing forms
of multiple sclerosis, to include clinically isolated syndrome,
relapsing-remitting disease, and active secondary progressive disease,
in adults. Subsequent to this approval, the USPTO received a patent
term restoration application for PONVORY (U.S. Patent No. RE43728) from
Actelion Pharmaceuticals Ltd. and the USPTO requested FDA's assistance
in determining the patent's eligibility for patent term restoration. In
a letter dated September 13, 2022, FDA advised the USPTO that this
human drug product had undergone a regulatory review period and that
the approval of PONVORY represented the first permitted commercial
marketing or use of the product. Thereafter, the USPTO requested that
FDA determine the product's regulatory review period.

II. Determination of Regulatory Review Period

    FDA has determined that the applicable regulatory review period for
PONVORY is 4,459 days. Of this time, 4,092 days occurred during the
testing phase of the regulatory review period, while 367 days occurred
during the approval phase. These periods of time were derived from the
following dates:
    1. The date an exemption under section 505(i) of the Federal Food,
Drug, and Cosmetic Act (FD&C Act) (21 U.S.C. 355(i)) became effective:
January 4, 2009. FDA has verified the applicant's claim that the date
the investigational new drug application became effective was on
January 4, 2009.
    2. The date the application was initially submitted with respect to
the human drug product under section 505 of the FD&C Act: March 18,
2020. FDA has verified the applicant's claim that the new drug
application (NDA) for PONVORY (NDA 213498) was initially submitted on
March 18, 2020.
    3. The date the application was approved: March 18, 2021. FDA has
verified the applicant's claim that NDA 213498 was approved on March
18, 2021.
    This determination of the regulatory review period establishes the
maximum potential length of a patent extension. However, the USPTO
applies several statutory limitations in its calculations of the actual
period for patent extension. In its application for patent extension,
this applicant seeks 5 years of patent term extension.

III. Petitions

    Anyone with knowledge that any of the dates as published are
incorrect may submit either electronic or written comments and, under
21 CFR 60.24, ask for a redetermination (see DATES). Furthermore, as
specified in Sec.  60.30 (21 CFR 60.30), any interested person may
petition FDA for a determination regarding whether the applicant for
extension acted with due diligence during the regulatory review period.
To meet its burden, the petition must comply with all the requirements
of Sec.  60.30, including but not limited to: must be timely (see
DATES), must be filed in accordance with Sec.  10.20, must contain
sufficient facts to merit an FDA investigation, and must certify that a
true and complete copy of the petition has been served upon the patent
applicant. (See H. Rept. 857, part 1, 98th Cong., 2d sess., pp. 41-42,
1984.) Petitions should be in the format specified in 21 CFR 10.30.
    Submit petitions electronically to https://www.regulations.gov at
Docket No. FDA-2013-S-0610. Submit written petitions (two copies are
required) to the Dockets Management Staff (HFA-305), Food and Drug
Administration, 5630 Fishers Lane, Rm. 1061, Rockville, MD 20852.

    Dated: December 21, 2023.
Lauren K. Roth,
Associate Commissioner for Policy.
[FR Doc. 2023-28509 Filed 12-26-23; 8:45 am]
BILLING CODE 4164-01-P


[Federal Register Volume 82, Number 168 (Thursday, August 31, 2017)]
[Proposed Rules]
[Pages 41379-41386]
[FR Doc No: 2017-18503]

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ENVIRONMENTAL PROTECTION AGENCY

40 CFR Part 52

[EPA-R05-OAR-2016-0343; FRL-9967-18-Region 5]

Air Plan Approval; Indiana; Infrastructure SIP Requirements for
the 2012 PM2.5 NAAQS

AGENCY: Environmental Protection Agency (EPA).

ACTION: Proposed rule.

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SUMMARY: The Environmental Protection Agency (EPA) is proposing to
approve elements of a state implementation plan (SIP) submission from
Indiana regarding the infrastructure requirements of section 110 of the
Clean Air Act (CAA) for the 2012 fine particulate matter
(PM2.5) National Ambient Air Quality Standards (NAAQS). The
infrastructure requirements are designed to ensure that the structural
components of each state's air quality management program are adequate
to meet the state's responsibilities under the CAA.

DATES: Comments must be received on or before October 2, 2017.

ADDRESSES: Submit your comments, identified by Docket ID No. EPA-R05-
OAR-2016-0343 at http://www.regulations.gov, or via email to
<EMAIL_ADDRESS>For comments submitted at Regulations.gov,
follow the online instructions for submitting comments. Once submitted,
comments cannot be edited or removed from Regulations.gov. For either
manner of submission, EPA may publish any comment received to its
public docket. Do not submit electronically any information you
consider to be Confidential Business Information (CBI) or other
information whose disclosure is restricted by statute. Multimedia
submissions (audio, video, etc.) must be accompanied by a written
comment.

The written comment is considered the official comment and should
include discussion of all points you wish to make. EPA will generally
not consider comments or comment contents located outside of the
primary submission (i.e. on the web, cloud, or other file sharing
system). For additional submission methods, please contact the person
identified in the FOR FURTHER INFORMATION CONTACT section. For the full
EPA public comment policy, information about CBI or multimedia
submissions, and general guidance on making effective comments, please
visit http://www2.epa.gov/dockets/commenting-epa-dockets.

FOR FURTHER INFORMATION CONTACT: Eric Svingen, Environmental Engineer,
Attainment Planning and Maintenance Section, Air Programs Branch (AR-
18J), Environmental Protection Agency, Region 5, 77 West Jackson
Boulevard, Chicago, Illinois 60604,<PHONE_NUMBER>,
<EMAIL_ADDRESS>
SUPPLEMENTARY INFORMATION: Throughout this document whenever ``we,''
``us,'' or ``our'' is used, we mean EPA. This supplementary information
section is arranged as follows:

I. What is the background of this SIP submission?
II. What guidance is EPA using to evaluate this SIP submission?
III. What is EPA's analysis of this SIP submission?
IV. What action is EPA taking?
V. Statutory and Executive Order Reviews

I. What is the background of this SIP submission?

A. What state submission does this rulemaking address?

    In this rulemaking, EPA is proposing to take action on a June 10,
2016, submission from the Indiana Department of Environmental
Management (IDEM) intended to address all applicable infrastructure
requirements for the 2012 PM2.5 NAAQS. On December 28, 2016,
IDEM supplemented this submittal with additional documentation intended
to address the transport requirements of Section 110(a)(2)(D) for the
2012 PM2.5 NAAQS; EPA will take action on this supplement in
a separate rulemaking.

B. Why did the state make this SIP submission?

    Under section 110(a)(1) and (2) of the CAA, states are required to
submit infrastructure SIPs to ensure that their SIPs provide for
implementation, maintenance, and enforcement of the NAAQS, including
the 2012 PM2.5 NAAQS. These submissions must contain any
revisions needed for meeting the applicable SIP requirements of section
110(a)(2), or certifications that their existing SIPs for the NAAQS
already meet those requirements.
    EPA highlighted this statutory requirement in an October 2, 2007,
guidance document entitled ``Guidance on SIP Elements Required Under
Sections 110(a)(1) and (2) for the 1997 8-hour Ozone and
PM2.5 \1\ National Ambient Air Quality Standards'' (2007
Guidance) and has issued additional guidance documents, the most recent
on September 13, 2013, entitled ``Guidance on Infrastructure State
Implementation Plan (SIP) Elements under CAA Sections 110(a)(1) and
(2)'' (2013 Guidance). The SIP submission referenced in this rulemaking
pertains to the applicable requirements of section 110(a)(1) and (2),
and addresses the 2012 PM2.5 NAAQS.
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    \1\ PM2.5 refers to particles with an aerodynamic
diameter of less than or equal to 2.5 micrometers, oftentimes
referred to as ``fine'' particles.
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C. What is the scope of this rulemaking?

    EPA is acting upon the SIP submission from Indiana that addresses
the infrastructure requirements of CAA section 110(a)(1) and (2) for
the 2012 PM2.5 NAAQS. The requirement for states to make SIP
submissions of this type arises out of CAA section 110(a)(1), which
states that states must make SIP submissions ``within 3 years (or such
shorter period as the Administrator may prescribe) after the
promulgation of a national primary ambient air quality standard (or any
revision thereof),'' and these SIP submissions are to provide for the
``implementation, maintenance, and enforcement'' of such NAAQS. The
statute directly imposes on states the duty to make these SIP
submissions, and the requirement to make the submissions is not
conditioned upon EPA's taking any action other than promulgating a new
or revised NAAQS. Section 110(a)(2) includes a list of specific
elements that ``[e]ach such plan'' submission must address.
    EPA has historically referred to these SIP submissions made for the
purpose of satisfying the requirements of CAA section 110(a)(1) and (2)
as ``infrastructure SIP'' submissions. Although the term
``infrastructure SIP'' does not appear in the CAA, EPA uses the term to
distinguish this particular type of SIP submission from submissions
that are intended to satisfy other SIP requirements under the CAA, such
as SIP submissions that address the nonattainment planning requirements
of part D and the prevention of significant deterioration (PSD)
requirements of part C of title I of the CAA, and ``regional haze SIP''
submissions required to address the visibility protection requirements
of CAA section 169A.
    In this rulemaking, EPA will not take action on three substantive
areas of section 110(a)(2): (i) Existing provisions related to excess
emissions during periods of start-up, shutdown, or malfunction
(``SSM'') at sources, that may be contrary to the CAA and EPA's
policies addressing such excess emissions; (ii) existing provisions
related to ``director's variance'' or ``director's discretion'' that
purport to permit revisions to SIP approved emissions limits with
limited public notice or without requiring further approval by EPA,
that may be contrary to the CAA; and, (iii) existing provisions for PSD
programs that may be inconsistent with current requirements of EPA's
``Final NSR Improvement Rule,'' 67 FR 80186 (December 31, 2002), as
amended by 72 FR 32526 (June 13, 2007) (``NSR Reform''). Instead, EPA
has the authority to address each one of these substantive areas in
separate rulemakings. A detailed history, interpretation, and rationale
as they relate to infrastructure SIP requirements can be found in EPA's
May 13, 2014, proposed rule entitled, ``Infrastructure SIP Requirements
for the 2008 Lead NAAQS'' in the section, ``What is the scope of this
rulemaking?'' (see 79 FR 27241 at 27242-27245).

II. What guidance is EPA using to evaluate this SIP submission?

    EPA's guidance for this infrastructure SIP submission is embodied
in the 2007 Guidance referenced above. Specifically, attachment A of
the 2007 Guidance (Required Section 110 SIP Elements) identifies the
statutory elements that states need to submit in order to satisfy the
requirements for an infrastructure SIP submission. As discussed above,
EPA issued additional guidance, the most recent being the 2013 Guidance
that further clarifies aspects of infrastructure SIPs that are not
NAAQS specific.

III. What is EPA's analysis of this SIP submission?

    Pursuant to section 110(a), states must provide reasonable notice
and opportunity for public hearing for all infrastructure SIP
submissions. On April 26, 2016, IDEM opened a 30-day comment period,
and provided the opportunity for public hearing. No comments or
requests for public hearing were received.
    Indiana provided a detailed synopsis of how various components of
its SIP meet each of the applicable

requirements in section 110(a)(2) for the 2012 PM2.5 NAAQS,
as applicable. The following review evaluates the state's submission.

A. Section 110(a)(2)(A)--Emission Limits and Other Control Measures

    This section requires SIPs to include enforceable emission limits
and other control measures, means or techniques, schedules for
compliance, and other related matters. EPA has long interpreted
emission limits and control measures for attaining the standards as
being due when nonattainment planning requirements are due.\2\ In the
context of an infrastructure SIP, EPA is not evaluating the existing
SIP provisions for this purpose. Instead, EPA is only evaluating
whether the state's SIP has basic structural provisions for the
implementation of the NAAQS.
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    \2\ See, e.g., EPA's final rule on ``National Ambient Air
Quality Standards for Lead.'' 73 FR 66964 at 67034.
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    IDEM's authority to adopt emissions standards and compliance
schedules is found at Indiana Code (IC) 13-14-8, IC 13-17-3-4, IC 13-
17-3-11, and IC 13-17-3-14. To maintain the 2012 PM2.5
NAAQS, Indiana implements controls and emission limits for particulate
matter in 326 Indiana Administrative Code (IAC) 6. Additionally,
Indiana provides emission limits for Clark, Dearborn, Dubois, Howard,
Marion, St. Joseph, Vanderburgh, Vigo, and Wayne counties at 326 IAC
6.5, and Lake County at 326 IAC 6.8. EPA proposes that Indiana has met
the infrastructure SIP requirements of section 110(a)(2)(A) with
respect to the 2012 PM2.5 NAAQS.
    As previously noted, EPA is not proposing to approve or disapprove
any existing state provisions or rules related to SSM or director's
discretion in the context of section 110(a)(2)(A).

B. Section 110(a)(2)(B)--Ambient Air Quality Monitoring/Data System

    This section requires SIPs to include provisions to provide for
establishing and operating ambient air quality monitors, collecting and
analyzing ambient air quality data, and making these data available to
EPA upon request. This review of the annual monitoring plan includes
EPA's determination that the state: (i) Monitors air quality at
appropriate locations throughout the state using EPA-approved Federal
Reference Methods or Federal Equivalent Method monitors; (ii) submits
data to EPA's Air Quality System (AQS) in a timely manner; and, (iii)
provides EPA Regional Offices with prior notification of any planned
changes to monitoring sites or the network plan.
    IDEM continues to operate an air monitoring network; EPA approved
the state's 2017 Annual Air Monitoring Network Plan on October 31,
2016, including the plan for PM2.5. IDEM enters air
monitoring data into AQS, and the state provides EPA with prior
notification when changes to its monitoring network or plan are being
considered. EPA proposes that Indiana has met the infrastructure SIP
requirements of section 110(a)(2)(B) with respect to the 2012
PM2.5 NAAQS.

C. Section 110(a)(2)(C)--Program for Enforcement of Control Measures;
PSD

    States are required to include a program providing for enforcement
of all SIP measures and the regulation of construction of new or
modified stationary sources to meet new source review (NSR)
requirements under PSD and nonattainment NSR (NNSR) programs. Part C of
the CAA (sections 160-169B) addresses PSD, while part D of the CAA
(sections 171-193) addresses NNSR requirements.
    The evaluation of each state's submission addressing the
infrastructure SIP requirements of section 110(a)(2)(C) covers: (i)
Enforcement of SIP measures; (ii) PSD provisions that explicitly
identify oxides of nitrogen (NOX) as a precursor to ozone in
the PSD program; (iii) identification of precursors to PM2.5
and the identification of PM2.5 and PM10 \3\
condensables in the PSD program; (iv) PM2.5 increments in
the PSD program; and, (v) greenhouse gas (GHG) permitting and the
``Tailoring Rule.'' \4\
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    \3\ PM10 refers to particles with an aerodynamic
diameter of less than or equal to 10 micrometers.
    \4\ In EPA's April 28, 2011, proposed rulemaking for
infrastructure SIPS for the 1997 ozone and PM2.5 NAAQS,
we stated that each state's PSD program must meet applicable
requirements for evaluation of all regulated NSR pollutants in PSD
permits (see 76 FR 23757 at 23760). This view was reiterated in
EPA's August 2, 2012, proposed rulemaking for infrastructure SIPs
for the 2006 PM2.5 NAAQS (see 77 FR 45992 at 45998). In
other words, if a state lacks provisions needed to adequately
address NOX as a precursor to ozone, PM2.5
precursors, PM2.5 and PM10 condensables,
PM2.5 increments, or the Federal GHG permitting
thresholds, the provisions of section 110(a)(2)(C) requiring a
suitable PSD permitting program must be considered not to be met
irrespective of the NAAQS that triggered the requirement to submit
an infrastructure SIP, including the 2012 PM2.5 NAAQS.
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Sub-Element 1: Enforcement of SIP Measures
    IDEM maintains an enforcement program to ensure compliance with SIP
requirements. IC 13-14-1-12 provides the Commissioner with the
authority to enforce rules ``consistent with the purpose of the air
pollution control laws.'' Additionally, IC 13-14-2-7 and IC 13-17-3-3
provide the Commissioner with the authority to assess civil penalties
and obtain compliance with any applicable rule a board has adopted in
order to enforce air pollution control laws. Lastly, IC 13-14-10-2
allows for an emergency restraining order that prevents any person from
causing, or introducing contaminants, that cause or contribute to air
pollution. EPA proposes that Indiana has met the enforcement of SIP
measures requirements of section 110(a)(2)(C) with respect to the 2012
PM2.5 NAAQS.
Sub-Element 2: PSD Provisions That Explicitly Identify NOX
as a Precursor to Ozone in the PSD Program
    EPA's ``Final Rule to Implement the 8-Hour Ozone National Ambient
Air Quality Standard--Phase 2; Final Rule to Implement Certain Aspects
of the 1990 Amendments Relating to New Source Review and Prevention of
Significant Deterioration as They Apply in Carbon Monoxide, Particulate
Matter, and Ozone NAAQS; Final Rule for Reformulated Gasoline'' (Phase
2 Rule) was published on November 29, 2005 (see 70 FR 71612). Among
other requirements, the Phase 2 Rule obligated states to revise their
PSD programs to explicitly identify NOX as a precursor to
ozone (70 FR 71612 at 71679, 71699-71700). This requirement was
codified in 40 CFR 51.166.\5\
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    \5\ Similar changes were codified in 40 CFR 52.21.
---------------------------------------------------------------------------

    The Phase 2 Rule required that states submit SIP revisions
incorporating the requirements of the rule, including these specific
NOX as a precursor to ozone provisions, by June 15, 2007
(see 70 FR 71612 at 71683, November 29, 2005).
    EPA approved revisions to Indiana's PSD SIP reflecting these
requirements on July 2, 2014 (see 79 FR 37646, July 2, 2014), and
therefore proposes that Indiana has met this set of infrastructure SIP
requirements of section 110(a)(2)(C) with respect to the 2012
PM2.5 NAAQS.
Sub-Element 3: Identification of Precursors to PM2.5 and the
Identification of PM2.5 and PM10 Condensables in
the PSD Program
    On May 16, 2008 (see 73 FR 28321), EPA issued the Final Rule on the
``Implementation of the New Source Review (NSR) Program for Particulate
Matter Less than 2.5 Micrometers (PM2.5)'' (2008 NSR Rule).
The 2008 NSR Rule finalized several new requirements for SIPs to
address sources that emit direct PM2.5 and other pollutants
that contribute to secondary

PM2.5 formation. One of these requirements is for NSR
permits to address pollutants responsible for the secondary formation
of PM2.5, otherwise known as precursors. In the 2008 rule,
EPA identified precursors to PM2.5 for the PSD program to be
SO2 and NOX (unless the state demonstrates to the
Administrator's satisfaction or EPA demonstrates that NOX
emissions in an area are not a significant contributor to that area's
ambient PM2.5 concentrations). The 2008 NSR Rule also
specifies that volatile organic compounds (VOCs) are not considered to
be precursors to PM2.5 in the PSD program unless the state
demonstrates to the Administrator's satisfaction or EPA demonstrates
that emissions of VOCs in an area are significant contributors to that
area's ambient PM2.5 concentrations.
    The explicit references to SO2, NOX, and VOCs
as they pertain to secondary PM2.5 formation are codified at
40 CFR 51.166(b)(49)(i)(b) and 40 CFR 52.21(b)(50)(i)(b). As part of
identifying pollutants that are precursors to PM2.5, the
2008 NSR Rule also required states to revise the definition of
``significant'' as it relates to a net emissions increase or the
potential of a source to emit pollutants. Specifically, 40 CFR
51.166(b)(23)(i) and 40 CFR 52.21(b)(23)(i) define ``significant'' for
PM2.5 to mean the following emissions rates: 10 tpy of
direct PM2.5; 40 tpy of SO2; and 40 tpy of
NOX (unless the state demonstrates to the Administrator's
satisfaction or EPA demonstrates that NOX emissions in an
area are not a significant contributor to that area's ambient
PM2.5 concentrations). The deadline for states to submit SIP
revisions to their PSD programs incorporating these changes was May 16,
2011 (see 73 FR 28321 at 28341, May 16, 2008).\6\
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    \6\ EPA notes that on January 4, 2013, the U.S. Court of Appeals
for the D.C. Circuit, in Natural Resources Defense Council v. EPA,
706 F.3d 428 (D.C. Cir.), held that EPA should have issued the 2008
NSR Rule in accordance with the CAA's requirements for
PM10 nonattainment areas (Title I, Part D, subpart 4),
and not the general requirements for nonattainment areas under
subpart 1 (Natural Resources Defense Council v. EPA, No. 08-1250).
As the subpart 4 provisions apply only to nonattainment areas, EPA
does not consider the portions of the 2008 rule that address
requirements for PM2.5 attainment and unclassifiable
areas to be affected by the court's opinion. Moreover, EPA does not
anticipate the need to revise any PSD requirements promulgated by
the 2008 NSR rule in order to comply with the court's decision.
Accordingly, EPA's approval of Indiana's infrastructure SIP as to
elements (C), (D)(i)(II), or (J) with respect to the PSD
requirements promulgated by the 2008 implementation rule does not
conflict with the court's opinion. The Court's decision with respect
to the nonattainment NSR requirements promulgated by the 2008
implementation rule also does not affect EPA's action on the present
infrastructure action. EPA interprets the CAA to exclude
nonattainment area requirements, including requirements associated
with a nonattainment NSR program, from infrastructure SIP
submissions due three years after adoption or revision of a NAAQS.
Instead, these elements are typically referred to as nonattainment
SIP or attainment plan elements, which would be due by the dates
statutorily prescribed under subpart 2 through 5 under part D,
extending as far as 10 years following designations for some
elements.
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    The 2008 NSR Rule did not require states to immediately account for
gases that could condense to form particulate matter, known as
condensables, in PM2.5 and PM10 emission limits
in NSR permits. Instead, EPA determined that states had to account for
PM2.5 and PM10 condensables for applicability
determinations and in establishing emissions limitations for
PM2.5 and PM10 in PSD permits beginning on or
after January 1, 2011. This requirement is codified in 40 CFR
51.166(b)(49)(i)(a) and 40 CFR 52.21(b)(50)(i)(a). Revisions to states'
PSD programs incorporating the inclusion of condensables were required
be submitted to EPA by May 16, 2011 (see 73 FR 28321 at 28341, May 16,
2008).
    EPA approved revisions to Indiana's PSD SIP reflecting these
requirements on July 2, 2014 (see 79 FR 37646), and therefore proposes
that Indiana has met this set of infrastructure SIP requirements of
section 110(a)(2)(C) with respect to the 2012 PM2.5 NAAQS.
Sub-Element 4: PM2.5 Increments in the PSD Program
    On October 20, 2010, EPA issued the final rule on the ``Prevention
of Significant Deterioration (PSD) for Particulate Matter Less Than 2.5
Micrometers (PM2.5)--Increments, Significant Impact Levels
(SILs) and Significant Monitoring Concentration (SMC)'' (2010 NSR
Rule). This rule established several components for making PSD
permitting determinations for PM2.5, including a system of
``increments'' which is the mechanism used to estimate significant
deterioration of ambient air quality for a pollutant. These increments
are codified in 40 CFR 51.166(c) and 40 CFR 52.21(c), and are included
in the table below.

Table 1--PM2.5 Increments Established by the 2010 NSR Rule in Micrograms
                             per Cubic Meter
------------------------------------------------------------------------
                                                   Annual
                                                 arithmetic  24-Hour max
                                                    mean
------------------------------------------------------------------------
Class I.......................................            1            2
Class II......................................            4            9
Class III.....................................            8           18
------------------------------------------------------------------------

    The 2010 NSR Rule also established a new ``major source baseline
date'' for PM2.5 as October 20, 2010, and a new trigger date
for PM2.5 as October 20, 2011. These revisions are codified
in 40 CFR 51.166(b)(14)(i)(c) and (b)(14)(ii)(c), and 40 CFR
52.21(b)(14)(i)(c) and (b)(14)(ii)(c). Lastly, the 2010 NSR Rule
revised the definition of ``baseline area'' to include a level of
significance of 0.3 micrograms per cubic meter, annual average, for
PM2.5. This change is codified in 40 CFR 51.166(b)(15)(i)
and 40 CFR 52.21(b)(15)(i).
    On July 12, 2012, and supplemented on December 12, 2012, IDEM
submitted revisions intended to address the increments established by
the 2010 NSR Rule for incorporation into the SIP, as well as the
revised major source baseline date, trigger date, and baseline area
level of significance for PM2.5. IDEM also requested that
these revisions satisfy any applicable infrastructure SIP requirements
related to PSD. Specifically, revisions to 326 IAC 2-2-6(b) contain the
Federal increments for PM2.5, 326 IAC 2-2-1(ee)(3) contains
the new major source baseline date for PM2.5 of October 20,
2010, 326 IAC 2-2-1(gg)(1)(C) contains the new trigger date for
PM2.5 of October 20, 2011, and 326 IAC 2-2-1(f)(1) contains
the new baseline area level of significance for PM2.5. It
should be noted that Indiana's submitted revisions explicitly include
only the PM2.5 increments as they apply to Class II areas,
and not the PM2.5 increments as they apply to Class I or
Class III areas. However, Indiana's requested revisions specify that if
areas in the state are classified as Class I or III in the future, it
would require that, pursuant to 40 CFR 52.21, those PSD increments be
adhered to.
    On August 11, 2014 (79 FR 46709), EPA finalized approval of the
applicable infrastructure SIP PSD revisions; therefore, we are
proposing that Indiana has met this set of infrastructure SIP
requirements of section 110(a)(2)(C) with respect to the 2012
PM2.5 NAAQS.
Sub-Element 5: GHG Permitting and the ``Tailoring Rule''
    With respect to the requirements of section 110(a)(2)(C) as well as
section 110(a)(2)(J), EPA interprets the CAA to

require each state to make an infrastructure SIP submission for a new
or revised NAAQS that demonstrates that the state has a complete PSD
permitting program meeting the current requirements for all regulated
NSR pollutants. The requirements of element D(i)(II) may also be
satisfied by demonstrating the air agency has a complete PSD permitting
program correctly addressing all regulated NSR pollutants. Indiana has
shown that it currently has a PSD program in place that covers all
regulated NSR pollutants, including GHGs.
    On June 23, 2014, the United States Supreme Court issued a decision
addressing the application of PSD permitting requirements to GHG
emissions. Utility Air Regulatory Group v. Environmental Protection
Agency, 134 S.Ct. 2427. The Supreme Court said that the EPA may not
treat GHGs as an air pollutant for purposes of determining whether a
source is a major source required to obtain a PSD permit. The Court
also said that the EPA could continue to require that PSD permits,
otherwise required based on emissions of pollutants other than GHGs,
contain limitations on GHG emissions based on the application of Best
Available Control Technology (BACT).
    In order to act consistently with its understanding of the Court's
decision pending further judicial action to effectuate the decision,
the EPA is not continuing to apply EPA regulations that would require
that SIPs include permitting requirements that the Supreme Court found
impermissible. Specifically, EPA is not applying the requirement that a
state's SIP-approved PSD program require that sources obtain PSD
permits when GHGs are the only pollutant (i) that the source emits or
has the potential to emit above the major source thresholds, or (ii)
for which there is a significant emissions increase and a significant
net emissions increase from a modification (e.g., 40 CFR
51.166(b)(48)(v)).
    EPA anticipates a need to revise Federal PSD rules in light of the
Supreme Court opinion. In addition, EPA anticipates that many states
will revise their existing SIP-approved PSD programs in light of the
Supreme Court's decision. The timing and content of subsequent EPA
actions with respect to the EPA regulations and state PSD program
approvals are expected to be informed by additional legal process
before the United States Court of Appeals for the District of Columbia
Circuit. At this juncture, EPA is not expecting states to have revised
their PSD programs for purposes of infrastructure SIP submissions and
is only evaluating such submissions to assure that the state's program
correctly addresses GHGs consistent with the Supreme Court's decision.
    At present, EPA is proposing that Indiana's SIP is sufficient to
satisfy elements C, D(i)(II), and J with respect to GHGs because the
PSD permitting program previously approved by EPA into the SIP
continues to require that PSD permits (otherwise required based on
emissions of pollutants other than GHGs) contain limitations on GHG
emissions based on the application of BACT. Although the approved
Indiana PSD permitting program may currently contain provisions that
are no longer necessary in light of the Supreme Court decision, this
does not render the infrastructure SIP submission inadequate to satisfy
elements C, (D)(i)(II), and J. The SIP contains the necessary PSD
requirements at this time, and the application of those requirements is
not impeded by the presence of other previously-approved provisions
regarding the permitting of sources of GHGs that EPA does not consider
necessary at this time in light of the Supreme Court decision.
    For the purposes of the 2012 PM2.5 NAAQS infrastructure
SIPs, EPA reiterates that NSR reform regulations are not within the
scope of these actions. Therefore, we are not taking action on existing
NSR reform regulations for Indiana. EPA approved Indiana's minor NSR
program on October 7, 1994 (see 59 FR 51108), and most recently
approved revisions to the program on March 16, 2015 (see 80 FR 13493).
IDEM and EPA rely on the minor NSR program to ensure that new and
modified sources not captured by the major NSR permitting programs do
not interfere with attainment and maintenance of the 2012
PM2.5 NAAQS.
    Certain sub-elements in this section overlap with elements of
section 110(a)(2)(D)(i), section 110(a)(2)(E) and section 110(a)(2)(J).
These links will be discussed in the appropriate areas below.

D. Section 110(a)(2)(D)--Interstate Transport

    Section 110(a)(2)(D)(i)(I) requires SIPs to include provisions
prohibiting any source or other type of emissions activity in one state
from contributing significantly to nonattainment, or interfering with
maintenance, of the NAAQS in another state. EPA is not taking action on
this infrastructure element in regards to the 2012 PM2.5
NAAQS and will do so in a future rulemaking.
    Section 110(a)(2)(D)(i)(II) requires SIPs to include provisions
prohibiting any source or other type of emissions activity in one state
from interfering with measures required to prevent significant
deterioration of air quality or to protect visibility in another state.
    EPA notes that Indiana's satisfaction of the applicable
infrastructure SIP PSD requirements for the 2012 PM2.5 NAAQS
has been detailed in the section addressing section 110(a)(2)(C). EPA
further notes that the proposed actions in that section related to PSD
are consistent with the proposed actions related to PSD for section
110(a)(2)(D)(i)(II), and they are reiterated below.
    EPA has previously approved revisions to Indiana's SIP that meet
certain requirements obligated by the Phase 2 Rule and the 2008 NSR
Rule. These revisions included provisions that: Explicitly identify
NOX as a precursor to ozone, explicitly identify
SO2 and NOX as precursors to PM2.5,
and regulate condensable PM2.5 and PM10 in
applicability determinations and establishing emissions limits. EPA has
also previously approved revisions to Indiana's SIP that incorporate
the PM2.5 increments and the associated implementation
regulations including the major source baseline date, trigger date, and
level of significance for PM2.5 per the 2010 NSR Rule. EPA
is proposing that Indiana's SIP contains provisions that adequately
address the 2012 PM2.5 NAAQS.
    States also have an obligation to ensure that sources located in
nonattainment areas do not interfere with a neighboring state's PSD
program. One way that this requirement can be satisfied is through an
NNSR program consistent with the CAA that addresses any pollutants for
which there is a designated nonattainment area within the state.
    Indiana's EPA-approved NNSR regulations are contained in 326 IAC 2-
3, and are consistent with 40 CFR 51.165. Therefore, EPA proposes that
Indiana has met all of the applicable PSD requirements for the 2012
PM2.5 NAAQS related to section 110(a)(2)(D)(i)(II).
    With regard to the applicable requirements for visibility
protection of section 110(a)(2)(D)(i)(II), states are subject to
visibility and regional haze program requirements under part C of the
CAA (which includes sections 169A and 169B). The 2013 Memo states that
these requirements can be satisfied by an approved SIP addressing
reasonably attributable visibility impairment, if required, or an
approved SIP addressing regional haze. In this rulemaking, EPA is not
proposing to approve or disapprove Indiana's satisfaction of the

visibility protection requirements of section 110(a)(2)(D)(i)(II) for
the 2012 PM2.5 NAAQS. Instead, EPA will evaluate Indiana's
compliance with these requirements in a separate rulemaking.\7\
---------------------------------------------------------------------------

    \7\ Indiana does have an approved regional haze plan for non-
EGUs. Indiana's plan for EGUs relied on the Clean Air Interstate
Rule that has been recently superseded by the Cross State Air
Pollution Rule to which Indiana EGU sources are also subject.
---------------------------------------------------------------------------

    Section 110(a)(2)(D)(ii) requires each SIP to contain adequate
provisions requiring compliance with the applicable requirements of
section 126 and section 115 (relating to interstate and international
pollution abatement, respectively).
    Section 126(a) requires new or modified sources to notify
neighboring states of potential impacts from the source. The statute
does not specify the method by which the source should provide the
notification. States with SIP-approved PSD programs must have a
provision requiring such notification by new or modified sources. A
lack of such a requirement in state rules would be grounds for
disapproval of this element. Indiana has provisions in its EPA-approved
PSD program in 326 IAC 2-2-15 (b)(3) requiring new or modified sources
to notify neighboring states of potential negative air quality impacts,
and has referenced this program as having adequate provisions to meet
the requirements of section 126(a). EPA is proposing that Indiana has
met the infrastructure SIP requirements of section 126(a) with respect
to the 2012 PM2.5 NAAQS. Indiana does not have any
obligations under any other subsection of section 126, nor does it have
any pending obligations under section 115. EPA, therefore, is proposing
that Indiana has met all applicable infrastructure SIP requirements of
section 110(a)(2)(D)(ii).

E. Section 110(a)(2)(E)--Adequate Resources

    This section requires each state to provide for adequate personnel,
funding, and legal authority under state law to carry out its SIP, and
related issues. Section 110(a)(2)(E)(ii) also requires each state to
comply with the requirements respecting state boards under section 128.
Sub-Element 1: Adequate Personnel, Funding, and Legal Authority Under
State Law To Carry Out Its SIP, and Related Issues
    Indiana's biennial budget and its environmental performance
partnership agreement with EPA document funding and personnel levels
for IDEM every two years. As discussed in earlier sections, IC 13-14-1-
12 provides the Commissioner of IDEM with the authority to enforce air
pollution control laws. Furthermore, IC 13-14-8, IC 13-17-3-11, and IC
13-17-3-14 contain the authority for IDEM to adopt air emissions
standards and compliance schedules. EPA proposes that Indiana has met
the infrastructure SIP requirements of this portion of section
110(a)(2)(E) with respect to the 2012 PM2.5 NAAQS.
Sub-Element 2: State Board Requirements Under Section 128 of the CAA
    Section 110(a)(2)(E) also requires each SIP to contain provisions
that comply with the state board requirements of section 128 of the
CAA. That provision contains two explicit requirements: (i) That any
board or body which approves permits or enforcement orders under this
chapter shall have at least a majority of members who represent the
public interest and do not derive any significant portion of their
income from persons subject to permits and enforcement orders under
this chapter, and (ii) that any potential conflicts of interest by
members of such board or body or the head of an executive agency with
similar powers be adequately disclosed.
    On November 29, 2012, IDEM submitted rules regarding its
Environmental Rules Board at IC 13-13-8 for incorporation into the SIP,
pursuant to section 128 of the CAA. On December 12, 2012, IDEM provided
a supplemental submission clarifying that the Environmental Rules Board
established by IC 13-13-8, which has the authority to adopt
environmental regulations under IC 4-22-2 and IC 13-14-9, does not have
the authority to approve enforcement orders or permitting actions as
outlined in section 128(a)(1) of the CAA. Therefore, section 128(a)(1)
of the CAA is not applicable in Indiana.
    Under section 128(a)(2), the head of the executive agency with the
power to approve enforcement orders or permits must adequately disclose
any potential conflicts of interest. IC 13-13-8-11 ``Disclosure of
conflicts of interest'' contains provisions that adequately satisfy the
requirements of section 128(a)(2). This section requires that each
member of the board shall fully disclose any potential conflicts of
interest relating to permits or enforcement orders. IC 13-13-8-4
defines the membership of the board, and the commissioner (of IDEM) or
his/her designee is explicitly included as a member of the board.
Therefore, when evaluated together in the context of section 128(a)(2),
the commissioner (of IDEM) or his/her designee must fully disclose any
potential conflicts of interest relating to permits or enforcement
orders under the CAA. EPA concludes that IDEM's submission as it
relates to the state board requirements under section 128 is consistent
with applicable CAA requirements. EPA approved these rules on December
6, 2013 (78 FR 77599). Therefore, EPA is proposing that IDEM has
satisfied the applicable infrastructure SIP requirements for this
section of 110(a)(2)(E) for the 2012 PM2.5 NAAQS.

F. Section 110(a)(2)(F)--Stationary Source Monitoring System

    States must establish a system to monitor emissions from stationary
sources and submit periodic emissions reports. Each plan shall also
require the installation, maintenance, and replacement of equipment,
and the implementation of other necessary steps, by owners or operators
of stationary sources to monitor emissions from such sources. The state
plan shall also require periodic reports on the nature and amounts of
emissions and emissions-related data from such sources, and correlation
of such reports by each state agency with any emission limitations or
standards established pursuant to this chapter. Lastly, the reports
shall be available at reasonable times for public inspection.
    The Indiana state rules for monitoring requirements are contained
in 326 IAC 3. Additional emissions reporting requirements are found in
326 IAC 2-6. Emission reports are available upon request by EPA or
other interested parties. EPA proposes that Indiana has satisfied the
infrastructure SIP requirements of section 110(a)(2)(F) with respect to
the 2012 PM2.5 NAAQS.

G. Section 110(a)(2)(G)--Emergency Powers

    This section requires that a plan provide for authority that is
analogous to what is provided in section 303 of the CAA, and adequate
contingency plans to implement such authority. The 2013 Memo states
that infrastructure SIP submissions should specify authority, rested in
an appropriate official, to restrain any source from causing or
contributing to emissions which present an imminent and substantial
endangerment to public health or welfare, or the environment.
    326 IAC 1-5 establishes air pollution episode levels based on
concentrations of criteria pollutants. This rule requires that
emergency reduction plans be submitted to the Commissioner of IDEM by
major air pollution sources, and

these plans must include actions that will be taken when each episode
level is declared, to reduce or eliminate emissions of the appropriate
air pollutants. Similarly, under IC 13-17-4, Indiana also has the
ability to declare an air pollution emergency and order all persons
causing or contributing to the conditions warranting the air pollution
emergency to immediately reduce or discontinue emission of air
contaminants. EPA proposes that Indiana has met the applicable
infrastructure SIP requirements of section 110(a)(2)(G) related to
authority to implement measures to restrain sources from causing or
contributing to emissions which present an imminent and substantial
endangerment to public health or welfare, or the environment with
respect to the 2012 PM2.5 NAAQS.

H. Section 110(a)(2)(H)--Future SIP Revisions

    This section requires states to have the authority to revise their
SIPs in response to changes in the NAAQS, availability of improved
methods for attaining the NAAQS, or to an EPA finding that the SIP is
substantially inadequate.
    IDEM continues to update and implement needed revisions to
Indiana's SIP as necessary to meet ambient air quality standards. As
discussed in previous sections, authority to adopt emissions standards
and compliance schedules is found at IC 13-4-8, IC 13-17-3-4, IC 13-17-
3-11, and IC 13-17-3-14. EPA proposes that Indiana has met the
infrastructure SIP requirements of section 110(a)(2)(H) with respect to
the 2012 PM2.5 NAAQS.

I. Section 110(a)(2)(I)--Nonattainment Area Plan or Plan Revisions
Under Part D

    The CAA requires that each plan or plan revision for an area
designated as a nonattainment area meet the applicable requirements of
part D of the CAA. Part D relates to nonattainment areas.
    EPA has determined that section 110(a)(2)(I) is not applicable to
the infrastructure SIP process. Instead, EPA takes action on part D
attainment plans through separate processes.

J. Section 110(a)(2)(J)--Consultation With Government Officials; Public
Notifications; PSD; Visibility Protection

    The evaluation of the submissions from Indiana with respect to the
requirements of section 110(a)(2)(J) are described below.
Sub-Element 1: Consultation With Government Officials
    States must provide a process for consultation with local
governments and Federal Land Managers (FLMs) carrying out NAAQS
implementation requirements.
    IDEM actively participates in the regional planning efforts that
include state rule developers, representatives from the FLMs, and other
affected stakeholders. Additionally, Indiana is an active member of the
Lake Michigan Air Director's Consortium, which consists of
collaboration with the States of Illinois, Wisconsin, Michigan,
Minnesota, and Ohio. EPA proposes that Indiana has met the
infrastructure SIP requirements of this portion of section 110(a)(2)(J)
with respect to the 2012 PM2.5 NAAQS.
Sub-Element 2: Public Notification
    Section 110(a)(2)(J) also requires states to notify the public if
NAAQS are exceeded in an area and to enhance public awareness of
measures that can be taken to prevent exceedances.
    IDEM monitors air quality data daily, and reports the air quality
index to the interested public and media, if necessary. IDEM also
participates in and submits information to EPA's AIRNOW program, and
maintains SmogWatch, which is an informational tool created by IDEM to
share air quality forecasts for each day. SmogWatch provides daily
information about ground-level ozone, particulate matter concentration
levels, health information, and monitoring data for seven regions in
Indiana. In addition, IDEM maintains a publicly available Web site that
allows interested members of the community and other stakeholders to
view current monitoring data summaries, including those for
PM2.5.\8\ EPA proposes that Indiana has met the
infrastructure SIP requirements of this portion of section 110(a)(2)(J)
with respect to the 2012 PM2.5 NAAQS.
---------------------------------------------------------------------------

    \8\ See http://www.in.gov/idem/airquality/2489.htm.
---------------------------------------------------------------------------

Sub-Element 3: PSD
    States must meet applicable requirements of section 110(a)(2)(C)
related to PSD. IDEM's PSD program in the context of infrastructure
SIPs has already been discussed above in the paragraphs addressing
section 110(a)(2)(C) and 110(a)(2)(D)(i)(II), and EPA notes that the
proposed actions for those sections are consistent with the proposed
actions for this portion of section 110(a)(2)(J).
    Therefore, EPA proposes that Indiana has met all of the
infrastructure SIP requirements for PSD associated with section
110(a)(2)(D)(J) for the 2012 PM2.5 NAAQS.
Sub-Element 4: Visibility Protection
    With regard to the applicable requirements for visibility
protection, states are subject to visibility and regional haze program
requirements under part C of the CAA (which includes sections 169A and
169B). In the event of the establishment of a new NAAQS, however, the
visibility and regional haze program requirements under part C do not
change. Thus, we find that there is no new visibility obligation
``triggered'' under section 110(a)(2)(J) when a new NAAQS becomes
effective. In other words, the visibility protection requirements of
section 110(a)(2)(J) are not germane to infrastructure SIPs for the
2012 PM2.5 NAAQS.

K. Section 110(a)(2)(K)--Air Quality Modeling/Data

    SIPs must provide for performing air quality modeling for
predicting effects on air quality of emissions from any NAAQS pollutant
and submission of such data to EPA upon request.
    IDEM continues to review the potential impact of all major and some
minor new and modified sources using computer models. Indiana's rules
regarding air quality modeling are contained in 326 IAC 2-2-4, 326 IAC
2-2-5, 326 IAC 2-2-6, and 326 IAC 2-2-7. These modeling data are
available to EPA or other interested parties upon request. EPA proposes
that Indiana has met the infrastructure SIP requirements of section
110(a)(2)(K) with respect to the 2012 PM2.5 NAAQS.

L. Section 110(a)(2)(L)--Permitting Fees

    This section requires SIPs to mandate each major stationary source
to pay permitting fees to cover the cost of reviewing, approving,
implementing, and enforcing a permit.
    IDEM implements and operates the title V permit program, which EPA
approved on December 4, 2001 (66 FR 62969); revisions to the program
were approved on August 13, 2002 (67 FR 52615). In addition to the
title V permit program, IDEM's EPA-approved PSD program, specifically
contained in 326 IAC 2-1.1-07, contains the provisions, requirements,
and structures associated with the costs for reviewing, approving,
implementing, and enforcing various types of permits. EPA proposes that
Indiana has met the infrastructure SIP requirements of section
110(a)(2)(L) with respect to the 2012 PM2.5 NAAQS.

M. Section 110(a)(2)(M)--Consultation/Participation by Affected Local
Entities

    States must consult with and allow participation from local
political subdivisions affected by the SIP.
    Any IDEM rulemaking procedure contained in IC 13-14-9 requires
public participation in the SIP development process. In addition, IDEM
ensures that the public hearing requirements of 40 CFR 51.102 are
satisfied during the SIP development process. EPA proposes that Indiana
has met the infrastructure SIP requirements of section 110(a)(2)(M)
with respect to the 2012 PM2.5 NAAQS.

IV. What action is EPA taking?

    EPA is proposing to approve most elements of a submission from
Indiana certifying that its current SIP is sufficient to meet the
required infrastructure elements under sections 110(a)(1) and (2) for
the 2012 PM2.5 NAAQS. EPA's proposed actions for the state's
satisfaction of infrastructure SIP requirements, by element of section
110(a)(2) are contained in the table below.

------------------------------------------------------------------------
                        Element                             2012 PM2.5
------------------------------------------------------------------------
(A)--Emission limits and other control measures........               A
(B)--Ambient air quality monitoring/data system........               A
(C)1--Program for enforcement of control measures......               A
(C)2--PSD..............................................               A
(D)1--I Prong 1: Interstate transport--significant                   NA
 contribution..........................................
(D)2--I Prong 2: Interstate transport--interfere with                NA
 maintenance...........................................
(D)3--II Prong 3: Interstate transport--prevention of                 A
 significant deterioration.............................
(D)4--II Prong 4: Interstate transport--protect                      NA
 visibility............................................
(D)5--Interstate and international pollution abatement.               A
(E)1--Adequate resources...............................               A
(E)2--State board requirements.........................               A
(F)--Stationary source monitoring system...............               A
(G)--Emergency power...................................               A
(H)--Future SIP revisions..............................               A
(I)--Nonattainment planning requirements of part D.....               *
(J)1--Consultation with government officials...........               A
(J)2--Public notification..............................               A
(J)3--PSD..............................................               A
(J)4--Visibility protection............................               *
(K)--Air quality modeling/data.........................               A
(L)--Permitting fees...................................               A
(M)--Consultation and participation by affected local                 A
 entities..............................................
------------------------------------------------------------------------

    In the above table, the key is as follows:

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

------------------------------------------------------------------------
A.........................................  Approve.
NA........................................  No Action/Separate
                                             Rulemaking.
 *........................................  Not germane to
                                             infrastructure SIPs.
------------------------------------------------------------------------

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 CAA 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 Orders 12866 (58
FR 51735, October 4, 1993) and 13563 (76 FR 3821, January 21, 2011);
     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, the SIP is not approved to apply on any Indian
reservation land or in any other area where EPA or an Indian tribe has
demonstrated that a tribe has jurisdiction. In those areas of Indian
country, the rule does not have tribal implications and will not impose
substantial direct costs on tribal governments or preempt tribal law as
specified by Executive Order 13175 (65 FR 67249, November 9, 2000).

List of Subjects in 40 CFR Part 52

    Environmental protection, Air pollution control, Incorporation by
reference, Intergovernmental relations, Particulate matter, Reporting
and recordkeeping requirements.

    Dated: August 21, 2017.
Robert A. Kaplan,
Acting Regional Administrator, Region 5.
[FR Doc. 2017-18503 Filed 8-30-17; 8:45 am]
BILLING CODE 6560-50-P


[Federal Register Volume 77, Number 231 (Friday, November 30, 2012)]
[Notices]
[Page 71474]
[FR Doc No: 2012-28994]

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DEPARTMENT OF TRANSPORTATION

Federal Aviation Administration

Commercial Space Transportation Advisory Committee--Charter
Renewal

AGENCY: Federal Aviation Administration (FAA), Department of
Transportation (DOT).

ACTION: Announcement of Charter Renewal of the Commercial Space
Transportation Advisory Committee (COMSTAC).

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

SUMMARY: FAA announces the charter renewal of the COMSTAC, a Federal
Advisory Committee that provides information, advice, and
recommendations to the Department of Transportation and the
Administrator of the Federal Aviation Administration (FAA) on the
critical matters facing the U.S. commercial space transportation
industry. This charter renewal will take effect on November 16, 2012,
and will expire after 2 years.

FOR FURTHER INFORMATION CONTACT: Paul Eckert, COMSTAC Designated
Federal Officer/Executive Director, FAA, Commercial Space
Transportation, 800 Independence Avenue SW., Rm. 331, Washington, DC
20591, telephone<PHONE_NUMBER>, Email<EMAIL_ADDRESS>
SUPPLEMENTARY INFORMATION: Pursuant to Section 10(a)(2) of the Federal
Advisory Committee Act (Pub. L. 92-463), FAA is giving notice of the
charter renewal for the COMSTAC. The primary goals of COMSTAC are to:
evaluate economic, technological, and institutional developments
relating to the U.S. commercial space transportation industry; provide
a forum for the discussion of problems involving the relationship
between industry activities and government requirements; and make
recommendations to the FAA Administrator on issues and approaches for
Federal policies and programs regarding the industry. COMSTAC
membership consists of senior executives from the commercial space
transportation industry; representatives from the satellite industry,
both manufacturers and users; state and local government officials;
representatives from firms providing insurance, financial investment
and legal services for commercial space activities; and representatives
from academia, space advocacy organizations, and industry associations.
Complete information regarding COMSTAC is available on the FAA Web site
at: http://www.faa.gov/about/office_org/headquarters_offices/ast/advisory_committee/.

    Issued in Washington, DC, November 7, 2012.
George C. Nield,
Associate Administrator for Commercial Space Transportation.
[FR Doc. 2012-28994 Filed 11-29-12; 8:45 am]
BILLING CODE 4910-13-P


[Federal Register Volume 86, Number 100 (Wednesday, May 26, 2021)]
[Notices]
[Page 28435]
[FR Doc No: 2021-11125]

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DEPARTMENT OF TRANSPORTATION

Federal Railroad Administration

[Docket Numbers FRA-2010-0028, -0029, -0039, -0042, -0043, -0045, -
0048, -0051, -0054, -0056, -0057, -0058, -0059, -0060, -0061, -0062, -
0064, -0065, and -0070]

Railroads' Requests To Amend Their Positive Train Control Safety
Plans and Positive Train Control Systems

AGENCY: Federal Railroad Administration (FRA), Department of
Transportation (DOT).

ACTION: Notice of availability and request for comments.

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

SUMMARY: This document provides the public with notice that, during
March, April, and early May of 2021, nineteen host railroads submitted
requests for amendments (RFA) to their FRA-approved Positive Train
Control Safety Plans (PTCSP). As these RFAs may involve requests for
FRA's approval of proposed material modifications to FRA-certified
positive train control (PTC) systems, FRA is publishing this notice and
inviting public comment on railroads' RFAs to their PTCSPs.

DATES: FRA will consider comments received by June 7, 2021. FRA may
consider comments received after that date to the extent practicable
and without delaying implementation of valuable or necessary
modifications to PTC systems.

ADDRESSES: Comments: Comments may be submitted by going to https://www.regulations.gov and following the online instructions for
submitting comments.
    Instructions: All submissions must include the agency name and the
applicable docket number. The relevant PTC docket numbers for the host
railroads that filed RFAs to their PTCSPs are cited above and in the
Supplementary Information section of this notice. For convenience, all
active PTC dockets are hyperlinked on FRA's website at https://railroads.dot.gov/train-control/ptc/ptc-annual-and-quarterly-reports.
All comments received will be posted without change to https://www.regulations.gov; this includes any personal information.

FOR FURTHER INFORMATION CONTACT: Gabe Neal, Deputy Staff Director,
Signal, Train Control, and Crossings Division, telephone:<PHONE_NUMBER>,
email<EMAIL_ADDRESS>
SUPPLEMENTARY INFORMATION: In general, Title 49 United States Code
(U.S.C.) Section 20157(h) requires FRA to certify that a host
railroad's PTC system complies with 49 CFR part 236, subpart I, before
the technology may be operated in revenue service. Before making
certain changes to an FRA-certified PTC system or the associated FRA-
approved PTCSP, a host railroad must submit, and obtain FRA's approval
of, an RFA to its PTCSP under Title 49 Code of Federal Regulations
(CFR) Section 236.1021.
    Under 49 CFR 236.1021(e), FRA's regulations provide that FRA will
publish a notice in the Federal Register and invite public comment in
accordance with 49 CFR part 211, if an RFA includes a request for
approval of a material modification of a signal and train control
system. Accordingly, this notice informs the public that host
railroads' March 2021 and April 2021 RFAs to their PTCSPs are available
in their respective public PTC dockets, and this notice provides an
opportunity for public comment on these RFAs.
    On March 3, 2021, CSX Transportation, Inc. (CSX) submitted an RFA
to its PTCSP for its Interoperable Electronic Train Management System
(I-ETMS), and that RFA is available in Docket No. FRA-2010-0028. On
March 12, 2021, Union Pacific Railroad (UP) submitted an RFA to its I-
ETMS PTCSP, and that RFA is available in Docket No. FRA-2010-0061. On
March 14, 2021, and April 20, 2021, respectively, the National Railroad
Passenger Corporation (Amtrak) submitted an RFA to its I-ETMS PTCSP and
an RFA to FRA's Type Approval and PTC System Certification of Amtrak's
Incremental Train Control System, and those RFAs are available in
Docket No. FRA-2010-0029. On March 16, 2021, Kansas City Southern
Railway (KCS) submitted an RFA to its I-ETMS PTCSP, and that RFA is
available in Docket No. FRA-2010-0059. On March 22, 2021, Norfolk
Southern Railway (NS) submitted an RFA to its I-ETMS PTCSP, and that
RFA is available in Docket No. FRA-2010-0060.
    In addition, on April 23, 2021, the following 19 host railroads
jointly submitted an RFA to their I-ETMS PTCSPs: Alaska Railroad
Corporation, Amtrak, The Belt Railway Company of Chicago, BNSF Railway,
Caltrain, Canadian National Railway, Canadian Pacific Railway (CP),
Consolidated Rail Corporation, CSX, Kansas City Terminal Railway, KCS,
New Mexico Rail Runner Express, Northeast Illinois Regional Commuter
Railroad Corporation (Metra), Northern Indiana Commuter Transportation
District, NS, South Florida Regional Transportation Authority, Southern
California Regional Rail Authority (Metrolink), Terminal Railroad
Association of St. Louis, and UP. Their joint RFA is available in
Docket Numbers FRA-2010-0028, -0029, -0039, -0042, -0043, -0045, -0048,
-0051, -0054, -0056, -0057, -0058, -0059, -0060, -0061, -0062, -0064, -
0065, and -0070. Finally, on May 5, 2021, CP submitted an RFA to its I-
ETMS PTCSP, and that RFA is available in Docket No. FRA-2010-0058.
    Interested parties are invited to comment on any RFAs to railroads'
PTCSPs by submitting written comments or data. During FRA's review of
railroads' RFAs, FRA will consider any comments or data submitted
within the timeline specified in this notice and to the extent
practicable, without delaying implementation of valuable or necessary
modifications to PTC systems. See 49 CFR 236.1021; see also 49 CFR
236.1011(e). Under 49 CFR 236.1021, FRA maintains the authority to
approve, approve with conditions, or deny railroads' RFAs to their
PTCSPs at FRA's sole discretion.

Privacy Act Notice

    In accordance with 49 CFR 211.3, FRA solicits comments from the
public to better inform its decisions. DOT posts these comments,
without edit, including any personal information the commenter
provides, to https://www.regulations.gov, as described in the system of
records notice (DOT/ALL-14 FDMS), which can be reviewed at https://www.transportation.gov/privacy. See https://www.regulations.gov/privacy-notice for the privacy notice of regulations.gov. To facilitate
comment tracking, we encourage commenters to provide their name, or the
name of their organization; however, submission of names is completely
optional. If you wish to provide comments containing proprietary or
confidential information, please contact FRA for alternate submission
instructions.

    Issued in Washington, DC.
Carolyn R. Hayward-Williams,
Director, Office of Railroad Systems and Technology.
[FR Doc. 2021-11125 Filed 5-25-21; 8:45 am]
BILLING CODE 4910-06-P


[Federal Register Volume 76, Number 223 (Friday, November 18, 2011)]
[Notices]
[Page 71577]
[FR Doc No: 2011-29836]

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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2011-N-0099]

Agency Information Collection Activities; Announcement of Office
of Management and Budget Approval; Followup Study for Infant Feeding
Practices Study II

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice.

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

SUMMARY: The Food and Drug Administration (FDA) is announcing that a
collection of information entitled ``Followup Study for Infant Feeding
Practices Study II'' has been approved by the Office of Management and
Budget (OMB) under the Paperwork Reduction Act of 1995.

FOR FURTHER INFORMATION CONTACT: Denver Presley, II, Office of
Information Management, Food and Drug Administration, 1350 Piccard Dr.,
PI50-400B, Rockville, MD 20850,<PHONE_NUMBER>.

SUPPLEMENTARY INFORMATION: On August 2, 2011, the Agency submitted a
proposed collection of information entitled ``Followup Study for Infant
Feeding Practices Study II'' to OMB for review and clearance under 44
U.S.C. 3507. An Agency may not conduct or sponsor, and a person is not
required to respond to, a collection of information unless it displays
a currently valid OMB control number. OMB has now approved the
information collection and has assigned OMB control number 0910-0696.
The approval expires on November 30, 2014. A copy of the supporting
statement for this information collection is available on the Internet
at http://www.reginfo.gov/public/do/PRAMain.

    Dated: November 14, 2011.
Leslie Kux,
Acting Assistant Commissioner for Policy.
[FR Doc. 2011-29836 Filed 11-17-11; 8:45 am]
BILLING CODE 4160-01-P


[Federal Register Volume 78, Number 87 (Monday, May 6, 2013)]
[Notices]
[Pages 26348-26349]
[FR Doc No: 2013-10635]

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DEPARTMENT OF ENERGY

Federal Energy Regulatory Commission

Combined Notice of Filings 1

    Take notice that the Commission received the following electric
corporate filings:

    Docket Numbers: EC13-98-000.
    Applicants: SWG Colorado, LLC, SWG Arapahoe, LLC.
    Description: Application under Section 203 of the Federal Power Act
of SWG Colorado, LLC, et al.
    Filed Date: 4/26/13.
    Accession Number: 20130426-5259.
    Comments Due: 5 p.m. e.t. 5/17/13.

    Docket Numbers: EC13-99-000.
    Applicants: Wabash Valley Power Association, Inc.
    Description: Joint Application of Wabash Valley Power Association,
Inc. for Authorization under Section 203 of the Federal Power Act.
    Filed Date: 4/29/13.
    Accession Number: 20130429-5051.
    Comments Due: 5 p.m. e.t. 5/20/13.

    Take notice that the Commission received the following electric
rate filings:
    Docket Numbers: ER10-2179-018; ER10-2181-018; ER10-2182-018.
    Applicants: R.E. Ginna Nuclear Power Plant, LLC, Nine Mile Point
Nuclear Station, LLC, Calvert Cliffs Nuclear Power Plant, LLC.
    Description: Notice of Change in Status of Calvert Cliffs Nuclear
Power Plant, LLC, et al.
    Filed Date: 4/26/13.
    Accession Number: 20130426-5252.
    Comments Due: 5 p.m. e.t. 5/17/13.

    Docket Numbers: ER12-281-003.
    Applicants: Northampton Generating Company, L.P.
    Description: Notice of Non-Material Change in Status of Northampton
Generating Company, L.P.
    Filed Date: 4/29/13.
    Accession Number: 20130429-5213.
    Comments Due: 5 p.m. e.t. 5/20/13.

    Docket Numbers: ER12-2068-003; ER10-2460-005; ER10-2461-005; ER12-
682-006; ER10-2463-005; ER11-2201-009; ER12-1311-005; ER10-2466-006;
ER11-4029-005; ER13-17-003.
    Applicants: Blue Sky East, LLC, Canandaigua Power Partners I, LLC,
Canandaigua Power Partners II, LLC, Erie Wind, LLC, Evergreen Wind
Power, LLC, Evergreen Wind Power III, LLC, Niagara Wind Power, LLC,
Stetson Holdings, LLC, Stetson Wind II, LLC, Vermont Wind, LLC.
    Description: Notice of Change in Status of Blue Sky East, LLC, et
al.
    Filed Date: 4/29/13.
    Accession Number: 20130429-5085.
    Comments Due: 5 p.m. e.t. 5/20/13.

    Docket Numbers: ER12-2178-006; ER10-2172-017; ER12-2311-006; ER11-
2016-012; ER10-2184-017; ER10-2183-014; ER10-1048-014 ER10-2176-018;
ER10-2192-017; ER11-2056-011; ER10-2178-017; ER10-2174-017; ER11-2014-
014; ER11-2013-014 ER10-3308-016; ER10-1020-013; ER10-1145-013; ER10-
1144-012; ER10-1078-013; ER10-1080-013; ER11-2010-014 ER10-1081-013;
ER10-2180-017; ER11-2011-013; ER12-2201-006; ER12-2528-005; ER11-2009-
013; ER11-3989-011 ER10-1143-013; ER11-2780-012; ER12-1829-006; ER11-
2007-012; ER12-1223-011; ER11-2005-014.
    Applicants: AV Solar Ranch 1, LLC, Baltimore Gas and Electric
Company, Beebe Renewable Energy, LLC, Cassia Gulch Wind Park, LLC, CER
Generation II, LLC, CER Generation, LLC, Commonwealth Edison Company,
Constellation Energy Commodities Group, Inc., Constellation Energy
Commodities Group Maine, LLC, Constellation Mystic Power, LLC,
Constellation NewEnergy, Inc., Constellation Power Source Generation
Inc., Cow Branch Wind Power, L.L.C.,CR Clearing, LLC, Criterion Power
Partners, LLC, Exelon Framingham, LLC,cExelon Generation Company, LLC,
Exelon New Boston, LLC, Exelon West Medway, LLC, Exelon Wind 4, LLC,
Exelon Wyman, LLC, Handsome Lake Energy, LLC, Harvest Windfarm, LLC,
Harvest II Windfarm, LLC, High Mesa Energy, LLC, Michigan Wind 1, LLC,
Michigan Wind 2, LLC, PECO Energy Company, Safe Harbor Water Power
Corporation, Shooting Star Wind Project, LLC, Tuana Springs Energy,
LLC, Wildcat Wind, LLC, Wind Capital Holdings, LLC.
    Description: Notice of Change in Status of AV Solar Ranch 1, LLC,
et al.
    Filed Date: 4/26/13.
    Accession Number: 20130426-5265.
    Comments Due: 5 p.m. e.t. 5/17/13.

    Docket Numbers: ER13-665-001.
    Applicants: Midcontinent Independent System Operator, Inc.
    Description: 2013-04-29 LTTR ARR Compliance Filing to be effective
3/29/2013.
    Filed Date: 4/29/13.
    Accession Number: 20130429-5114.
    Comments Due: 5 p.m. e.t. 5/20/13.

    Docket Numbers: ER13-834-001.
    Applicants: Southwest Power Pool, Inc.
    Description: Registration Freeze Compliance to be effective 4/1/
2013.
    Filed Date: 4/26/13.
    Accession Number: 20130426-5234.
    Comments Due: 5 p.m. e.t. 5/17/13.

    Docket Numbers: ER13-1352-000.
    Applicants: Massachusetts Electric Company.
    Description: Interconnection Agreement Between Massachusetts
Electric Co. and Ameresco to be effective 6/26/2013.
    Filed Date: 4/26/13.
    Accession Number: 20130426-5231.
    Comments Due: 5 p.m. e.t. 5/17/13.

    Docket Numbers: ER13-1353-000.
    Applicants: PJM Interconnection, L.L.C.
    Description: Revisions to the OATT & OA re Demand Response M&V
Procedure Revisions to be effective 6/25/2013.

    Filed Date: 4/26/13.
    Accession Number: 20130426-5232.
    Comments Due: 5 p.m. e.t. 5/17/13.

    Docket Numbers: ER13-1354-000.
    Applicants: Massachusetts Electric Company.
    Description: Interconnection Agreement Between Mass. Electric Co.
and Casella Waste Systems to be effective 6/26/2013.
    Filed Date: 4/26/13.
    Accession Number: 20130426-5235.
    Comments Due: 5 p.m. e.t. 5/17/13.

    Docket Numbers: ER13-1355-000.
    Applicants: PacifiCorp.
    Description: Termination of PacifiCorp Rate Schedule No. 611, the
Northern Tier Transmission Group Second Amended and Restated 2007
Funding Agreement.
    Filed Date: 4/26/13.
    Accession Number: 20130426-5245.
    Comments Due: 5 p.m. e.t. 5/17/13.

    Docket Numbers: ER13-1356-000.
    Applicants: Duke Energy Florida, Inc.
    Description: Annual update of cost factors for Florida Power Corp.
Interchange Agreements to be effective 5/1/2013.
    Filed Date: 4/29/13.
    Accession Number: 20130429-5028.
    Comments Due: 5 p.m. e.t. 5/20/13.

    Docket Numbers: ER13-1357-000.
    Applicants: Duke Energy Progress, Inc.
    Description: Notice of Succession to be effective 4/29/2013.
    Filed Date: 4/29/13.
    Accession Number: 20130429-5128.
    Comments Due: 5 p.m. e.t. 5/20/13.

    Docket Numbers: ER13-1358-000.
    Applicants: Duke Energy Florida, Inc.
    Description: Notice of Succession to be effective 4/29/2013.
    Filed Date: 4/29/13.
    Accession Number: 20130429-5139.
    Comments Due: 5 p.m. e.t. 5/20/13.

    Take notice that the Commission received the following electric
securities filings:
    Docket Numbers: ES13-22-000.
    Applicants: MDU Resources Group, Inc.
    Description: Application for MDU Resources Group, Inc. for
authority to issues shares of common stock.
    Filed Date: 4/29/13.
    Accession Number: 20130429-5211.
    Comments Due: 5 p.m. e.t. 5/20/13.

    Take notice that the Commission received the following electric
reliability filings.
    Docket Numbers: RD13-9-000.
    Applicants: North American Electric Reliability Corporation.
    Description: Joint Petition of North American Electric Reliability
Corporation and Southwest Power Pool Regional Entity for Approval of
Proposed Regional Reliability Standard PRC-006-SPP-01--Underfrequency
Load Shedding.
    Filed Date: 4/26/13.
    Accession Number: 20130426-5268.
    Comments Due: 5 p.m. e.t. 5/20/13.

    The filings are accessible in the Commission's eLibrary system by
clicking on the links or querying the docket number.
    Any person desiring to intervene or protest in any of the above
proceedings must file in accordance with Rules 211 and 214 of the
Commission's Regulations (18 CFR 385.211 and 385.214) on or before 5:00
p.m. Eastern time on the specified comment date. Protests may be
considered, but intervention is necessary to become a party to the
proceeding.
    eFiling is encouraged. More detailed information relating to filing
requirements, interventions, protests, service, and qualifying
facilities filings can be found at: http://www.ferc.gov/docs-filing/efiling/filing-req.pdf. For other information, call<PHONE_NUMBER>
(toll free). For TTY, call<PHONE_NUMBER>.

    Dated: April 29, 2013.
Nathaniel J. Davis, Sr.,
Deputy Secretary.
[FR Doc. 2013-10635 Filed 5-3-13; 8:45 am]
BILLING CODE 6717-01-P


[Federal Register Volume 85, Number 129 (Monday, July 6, 2020)]
[Notices]
[Pages 40283-40284]
[FR Doc No: 2020-14422]

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DEPARTMENT OF ENERGY

Federal Energy Regulatory Commission

[Docket No. PL19-4-000]

Commission Information Collection Activities; Request for
Emergency Processing for FERC-6(PL)

AGENCY: Federal Energy Regulatory Commission.

ACTION: Notice of information collection and request for emergency
processing.

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

SUMMARY: In compliance with the requirements of the Paperwork Reduction
Act of 1995 (PRA), the Federal Energy Regulatory Commission (Commission
or FERC) is submitting an emergency request for the information
collection, FERC-6(PL) (One-time Re-filing Under Docket PL19-4 of Page
700 of Form No. 6 (Annual Report of Oil Pipeline Companies)), to the
Office of Management and Budget (OMB) for approval.

FOR FURTHER INFORMATION CONTACT: Ellen Brown may be reached by email at
<EMAIL_ADDRESS>and telephone at<PHONE_NUMBER>.

SUPPLEMENTARY INFORMATION:
    Title: FERC-6(PL), One-Time Refiling Under Docket No. PL19-4 of
Page 700 of Form 6 (Annual Report of Oil Pipeline Companies).
    OMB Control No.: TBD.
    Type of Request: Request for Emergency Processing and Approval
Pursuant to 5 CFR 1320.13.
    Abstract: In the Energy Policy Act of 1992, Congress required the
Commission to develop a simplified method for changing oil pipeline
rates. In response, the Commission established an indexing methodology
that allows oil pipelines to change rates based upon an annual
industry-wide index.\1\ The Commission committed to review the index
level every five years to ensure that the index level continues to
reflect annual industry-wide cost changes.\2\ In Order No. 561 and each
successive five-year review, the Commission calculated the index level
based upon the Kahn Methodology, which determines the differences over
the prior five-year period between changes in costs reported on page
700

of FERC Form No. 6 \3\ and changes in the Producer Price Index for
Finished Goods (PPI-FG). The index level is then set at PPI-FG plus (or
minus) this differential. In the 2020 five-year review, the Commission
will measure pipeline cost changes over the period from 2014-2019 in
order to establish the index level for the five-year period from 2021-
2026.
---------------------------------------------------------------------------

    \1\ Revisions to Oil Pipeline Regulations Pursuant to the Energy
Policy Act of 1992, Order No. 561, FERC Stats. & Regs. 30,985, at
30,947 (1993), order on reh'g, Order No. 561-A, FERC Stats. & Regs.
31,000 (1994), aff'd, Ass'n of Oil Pipe Lines v. FERC, 83 F.3d 1424
(D.C. Cir. 1996).
    \2\ Id.
    \3\ FERC Form No. 6 (OMB Control No. 1902-0022), the Annual
Report of Oil Pipeline Companies, is required by 18 CFR 357.2.
---------------------------------------------------------------------------

    On May 21, 2020, the Commission issued a Policy Statement on
Determining Return on Equity for Natural Gas and Oil Pipelines (ROE
Policy Statement), in which the Commission adopted a revised
methodology for determining return on equity (ROE) used to calculate
oil pipelines' Annual Cost of Service on page 700 of FERC Form No.
6.\4\ The issuance of the ROE Policy Statement may affect the oil
pipeline industry's 2019 costs reported on page 700 that the Commission
will use in the 2020 five-year review. Thus, the ROE Policy Statement
encouraged pipelines to file, on a one-time basis, updated page 700
data for 2019 reflecting the Commission's revised methodology and
solicited comments on this voluntary information collection pursuant to
the PRA by June 26, 2020.
---------------------------------------------------------------------------

    \4\ Inquiry Regarding the Commission's Policy for Determining
Return on Equity, 171 FERC 61,155 (2020).
---------------------------------------------------------------------------

    The Commission received five comments in response to the ROE Policy
Statement, one of which addressed the information collection for oil
pipelines. On June 11, 2020, Liquids Shippers Group filed a motion for
reconsideration of the ROE Policy Statement and a request for expedited
action (Motion). The Motion asserts that the voluntary information
collection improperly gives pipelines discretion to file ROEs that are
higher, which would increase the index level, while refraining from
filing ROEs that are lower, which would decrease the index level. Thus,
the Motion states that the information collection will bias the record
in the five-year review proceeding.
    The Commission will address the Motion in due course. However, the
Motion should not affect the Commission's request for OMB's emergency
processing and approval of the FERC-6(PL). First, the Motion does not
reference the PRA or the burdens the information collection would
impose. Second, the Motion addresses the information collection from
the perspective of shippers, rather than pipelines that will be subject
to the information collection. Third, the Motion seeks to convert this
voluntary information collection into a mandatory one and implementing
a mandatory collection at this time would likely delay the five-year
review. Fourth, the Commission will address the merits of Liquids
Shippers Group's claims regarding the calculation of the index level in
the five-year review proceeding itself, where the Commission has
requested comments on this very issue.\5\ The effect of this data on
the Commission's analysis in the five-year review will depend upon how
many pipelines file updated page 700 data and the comments that the
Commission receives.
---------------------------------------------------------------------------

    \5\ Five-Year Review of the Oil Pipeline Index, 171 FERC 61,239
at PP 2, 8.
---------------------------------------------------------------------------

    Accordingly, the Commission requests that OMB review and approve
FERC-6(PL) [the request to have pipelines voluntarily refile, on a one-
time basis, page 700 of their 2019 FERC Form No. 6] in order to reflect
the ROE Policy Statement. The Commission requests emergency processing
of this information collection because this collection is essential to
the mission of the Commission and public harm is reasonably likely to
occur if normal clearance procedures are followed.
    FERC submitted a formal request to OMB on June 29, 2020 for
emergency approval of the one-time FERC-6(PL).\6\ The Commission
requested an OMB decision on FERC-6(PL) by July 6, 2020.
---------------------------------------------------------------------------

    \6\ The request pending at OMB (ICR<PHONE_NUMBER>-002) for
approval of the voluntary re-filing of Page 700 of the FERC Form No.
6 will be retracted. It is being replaced by the request for
emergency approval of the FERC-6(PL).
---------------------------------------------------------------------------

    Estimate of Annual Burden.\7\ The Commission estimates the annual
public reporting burden and cost \8\ for the information collection as:
---------------------------------------------------------------------------

    \7\ Burden is the total time, effort, or financial resources
expended by persons to generate, maintain, retain, or disclose or
provide information to or for a Federal agency. For further
explanation of what is included in the information collection
burden, refer to Title 5 of Code of Federal Regulations 1320.3.
    \8\ The Commission staff estimates that the industry's skill set
and cost (for wages and benefits) for performing the ROE study and
completing and filing FERC-6(PL) is comparable to the Commission's
skill set and average cost. The FERC 2019 average salary plus
benefits for one FERC full-time equivalent (FTE) is $167,091/year or
$80.00/hour.
    \9\ The Commission staff has conservatively assumed a 100
percent voluntary response rate.

                                             FERC-6(PL)--Estimated Annual Burden Due to Docket No. PL19-4\9\
                                                                [Figures may be rounded]
--------------------------------------------------------------------------------------------------------------------------------------------------------
                                                 Annual  number
                                    Number of     of  responses    Total number     Average burden      Total annual burden hours  and       Cost per
                                    potential          per         of responses   hours and cost ($)        total annual cost  ($)       respondent  ($)
                                   respondents     Respondent                        per response
                                            (1)             (2)    (1)*(2) = (3)  (4)...............  (3)*(4) = (5)....................  (5) / (1) = (6)
--------------------------------------------------------------------------------------------------------------------------------------------------------
Updated ROE Study..............             244               1              244  187.5 hrs.;         45,750 hrs.; $3,660,000..........          $15,000
                                                                                $15,000.
Refile FERC Form No. 6, page                244               1              244  0.5 hrs.; $40.....  122 hrs.; $9,760.................               40
 700.
                                ------------------------------------------------------------------------------------------------------------------------
    Total, Due to PL19-4.......             244               1              244  ..................  45,872 hrs.; $3,669,760..........           15,040
--------------------------------------------------------------------------------------------------------------------------------------------------------

    Dated: June 29, 2020.
Kimberly D. Bose,
Secretary.
[FR Doc. 2020-14422 Filed 7-2-20; 8:45 am]
BILLING CODE 6717-01-P