[Federal Register Volume 80, Number 87 (Wednesday, May 6, 2015)]
[Notices]
[Pages 26061-26062]
[FR Doc No: 2015-10482]

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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2015-D-1376]

Leveraging Existing Clinical Data for Extrapolation to Pediatric
Uses of Medical Devices; Draft Guidance for Industry and Food and Drug
Administration Staff; Availability

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice.

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SUMMARY: The Food and Drug Administration (FDA) is announcing the
availability of the draft guidance entitled ``Leveraging Existing
Clinical Data for Extrapolation to Pediatric Uses of Medical Devices.''
This draft guidance is being issued to explain the circumstances in
which it may be appropriate to leverage existing clinical data to
support pediatric device indications in premarket approval applications
(PMAs) and humanitarian device exemptions (HDEs). The draft guidance
also describes the approach that FDA would use to determine whether
extrapolation is appropriate in medical devices, and the factors that
would be considered within a statistical model for extrapolation.
Extrapolation may be appropriate when the course of the disease or
condition and the effects of the device are sufficiently similar in
adults and pediatric patients and the adult data are of high quality
for borrowing. This draft guidance is not final nor is it in effect at
this time.

DATES: Although you can comment on any guidance at any time (see 21 CFR
10.115(g)(5)), to ensure that the Agency considers your comment of this
draft guidance before it begins work on the final version of the
guidance, submit either electronic or written comments on the draft
guidance by August 4, 2015.

ADDRESSES: An electronic copy of the guidance document is available for
download from the Internet. See the SUPPLEMENTARY INFORMATION section
for information on electronic access to the guidance. Submit written
requests for a single hard copy of the draft guidance document entitled
``Leveraging Existing Clinical Data for Extrapolation to Pediatric Uses
of Medical Devices'' to the Office of the Center Director, Guidance and
Policy Development, Center for Devices and Radiological Health (CDRH),
Food and Drug Administration, 10903 New Hampshire Ave., Bldg. 66, Rm.
5431, Silver Spring, MD 20993-0002. Send one self-addressed adhesive
label to assist that office in processing your request.
    Submit electronic comments on the draft guidance to http://www.regulations.gov. Submit written comments to the Division of Dockets
Management (HFA-305), Food and Drug Administration, 5630 Fishers Lane,
Rm. 1061, Rockville, MD 20852. Identify comments with the docket number
found in brackets in the heading of this document.

FOR FURTHER INFORMATION CONTACT: Jacqueline Francis, Center for Devices
and Radiological Health, Food and Drug Administration, 10903 New
Hampshire Ave., Bldg. 66, Silver Spring, MD 20993-0002,<PHONE_NUMBER>;
or Stephen Ripley, Center for Biologics Evaluation and Research (CBER),
Food and Drug Administration, 10903 New Hampshire Ave., Bldg. 71, Rm.
7301, Silver Spring, MD 20993-0002,<PHONE_NUMBER>.

SUPPLEMENTARY INFORMATION:

I. Background

    Section 520(m)(6)(E)(i) of the Federal Food, Drug, and Cosmetic Act
(FD&C Act) (21 U.S.C. 360j) defines pediatric device patients as
persons aged 21 or younger at the time of their diagnosis or treatment
(i.e., from birth through the 21st year of life, up to but not
including the 22d birthday). Pediatric subpopulations are defined in
section 520(m)(6)(E)(ii) (and adopted by reference in section 515A(c)
of the FD&C Act (21 U.S.C. 360e)) to be neonates, infants, children,
and adolescents.
    In an attempt to promote pediatric medical device development, CDRH
published a final guidance document in 2004 entitled ``Premarket
Assessment of Pediatric Medical Devices'' (Ref. 1). This 2004 document
indicates that data can be extrapolated to support effectiveness and,
on a limited basis, safety for premarket approval applications (PMAs)
when consistent with scientific principles. Congress was aware of this
2004 document when it passed the Food and Drug Administration
Amendments Act of 2007 (FDAAA). Title III of FDAAA is the Pediatric
Medical Device Safety and Improvement Act (PMDSIA). The FDAAA
specifically authorized the use of adult data to demonstrate pediatric
effectiveness. While safety exploration is not discussed in PMDSIA, FDA
believes that there are specific cases where it will be appropriate to
consider extrapolation of existing clinical safety data to support or
enhance evidence for pediatric indications. FDA seeks comment on the
appropriateness of extrapolating from adult clinical data to support
medical device safety in pediatric patients.
    FDA aims to increase the availability of safe and effective
pediatric devices while ensuring that the approval of these devices is
based on valid scientific evidence. Extrapolation of adult data for
pediatric use may benefit pediatric patients by making it possible for
devices to be approved for pediatric-specific indications and labeling,
even when there is little or no existing pediatric data. Extrapolation
facilitates the use of available relevant data by making optimal use of
what is already known about device effects in other

populations to support indications in the pediatric population. If
extrapolation is found to be appropriate, FDA believes that statistical
modeling and methods can be used to increase the precision of pediatric
inferences.
    This guidance should be used in conjunction with other device-
specific guidances to help ensure that medical devices intended for use
in pediatric population provide reasonable assurance of safety and
effectiveness.

II. Significance of Guidance

    This draft guidance is being issued consistent with FDA's good
guidance practices regulation (21 CFR 10.115). The draft guidance, when
finalized, will represent the Agency's current thinking on
extrapolation of data for pediatric uses. It does not create or confer
any rights for or on any person and does not operate to bind FDA or the
public. An alternative approach may be used if such approach satisfies
the requirements of the applicable statute and regulations.

III. Electronic Access

    Persons interested in obtaining a copy of the draft guidance may do
so by downloading an electronic copy from the Internet. A search
capability for all Center for Devices and Radiological Health guidance
documents is available at http://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/GuidanceDocuments/default.htm. Guidance
documents are also available at http://www.regulations.gov. Persons
unable to download an electronic copy of ``Leveraging Existing Clinical
Data for Extrapolation to Pediatric Uses of Medical Devices'' may send
an email request to<EMAIL_ADDRESS>to receive an electronic
copy of the document. Please use the document number 1827 to identify
the guidance you are requesting.

IV. Paperwork Reduction Act of 1995

    This draft guidance refers to previously approved collections of
information found in FDA regulations. These collections of information
are subject to review by the Office of Management and Budget (OMB)
under the Paperwork Reduction Act of 1995 (44 U.S.C. 3501-3520). The
collections of information in 21 CFR parts 801 and 809 have been
approved under OMB control number 0910-0485 (medical device labeling);
the collections of information in 21 CFR part 812 have been approved
under OMB control number 0910-0078 (investigational device exemptions);
the collections of information in 21 CFR part 814 have been approved
under OMB control number 0910-0231 (subparts A through E, premarket
approval).

V. Reference

    The following reference have been placed on display in the Division
of Dockets Management (see ADDRESSES), and may be seen by interested
persons between 9 a.m. and 4 p.m., Monday through Friday, and are
available electronically at http://www.regulations.gov. (FDA has
verified the Web site address, but we are not responsible for any
subsequent changes to the Web sites after this document publishes in
the Federal Register.)

1. FDA guidance entitled ``Premarket Assessment of Pediatric Medical
Devices,'' March 24, 2014, available at http://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/GuidanceDocuments/ucm089740.htm.

VI. Comments

    Interested persons may submit either electronic comments regarding
this document to http://www.regulations.gov or written comments to the
Division of Dockets Management (see ADDRESSES). It is only necessary to
send one set of comments. Identify comments with the docket number
found in brackets in the heading of this document. Received comments
may be seen in the Division of Dockets Management between 9 a.m. and 4
p.m., Monday through Friday, and will be posted to the docket at http://www.regulations.gov.

    Dated: April 30, 2015.
Leslie Kux,
Associate Commissioner for Policy.
[FR Doc. 2015-10482 Filed 5-5-15; 8:45 am]
BILLING CODE 4164-01-P


[Federal Register Volume 81, Number 222 (Thursday, November 17, 2016)]
[Notices]
[Pages 81235-81236]
[FR Doc No: 2016-27646]

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DEPARTMENT OF TRANSPORTATION

Federal Motor Carrier Safety Administration

[Docket No. FMCSA-2009-0294; FMCSA-2011-0326; FMCSA-2011-0327; FMCSA-
2011-0367; FMCSA-2013-0192]

Qualification of Drivers; Exemption Applications; Diabetes

AGENCY: Federal Motor Carrier Safety Administration (FMCSA), DOT.

ACTION: Notice of final disposition.

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SUMMARY: FMCSA announces its decision to renew exemptions of 36
individuals from its prohibition in the Federal Motor Carrier Safety
Regulations (FMCSRs) against persons with insulin-treated diabetes
mellitus (ITDM) from operating commercial motor vehicles (CMVs) in
interstate commerce. The exemptions enable these individuals with ITDM
to continue to operate CMVs in interstate commerce.

DATES: Each group of renewed exemptions were effective on the dates
stated in the discussions below and will expire on the dates stated in
the discussions below.

FOR FURTHER INFORMATION CONTACT: Ms. Christine A. Hydock, Chief,
Medical Programs Division,<PHONE_NUMBER><EMAIL_ADDRESS>FMCSA,
Department of Transportation, 1200 New Jersey Avenue SE., Room W64-224,
Washington, DC 20590-0001. Office hours are from 8 a.m. to 5:30 p.m.,
e.t., Monday through Friday, except Federal holidays. If you have
questions regarding viewing or submitting material to the docket,
contact Docket Services, telephone<PHONE_NUMBER>.

SUPPLEMENTARY INFORMATION:

I. Electronic Access

    You may see all the comments online through the Federal Document
Management System (FDMS) at: http://www.regulations.gov.
    Docket: For access to the docket to read background documents or
comments, go to http://www.regulations.gov and/or Room W12-140 on the
ground level of the West Building, 1200 New Jersey Avenue SE.,
Washington, DC, between 9 a.m. and 5 p.m., Monday through Friday,
except Federal holidays.
    Privacy Act: In accordance with 5 U.S.C. 553(c), DOT solicits
comments from the public to better inform its rulemaking process. DOT
posts these comments, without edit, including any personal information
the commenter provides, to http://www.regulations.gov, as described in
the system of records notice (DOT/ALL-14 FDMS), which can be reviewed
at http://www.dot.gov/privacy.

II. Background

    On January 11, 2016, FMCSA published a notice announcing its
decision to renew exemptions for 36 individuals from the insulin-
treated diabetes mellitus prohibition in 49 CFR 391.41(b)(3) to operate
a CMV in interstate commerce and requested comments from the public (80
FR 74196). The public comment period ended on February 10, 2016 and no
comments were received.
    As stated in the previous notice, FMCSA has evaluated the
eligibility of these applicants and determined that renewing these
exemptions would

achieve a level of safety equivalent to or greater than the level that
would be achieved by complying with the current regulation 49 CFR
391.41(b)(3).
    The physical qualification standard for drivers regarding diabetes
found in 49 CFR 391.41(b)(3) states that a person is physically
qualified to drive a CMV if that person has no established medical
history or clinical diagnosis of diabetes mellitus currently requiring
insulin for control.

III. Discussion of Comments

    FMCSA received no comments in this preceding.

IV. Conclusion

    Based upon its evaluation of the 36 renewal exemption applications
and that no comments were received, FMCSA confirms its decision to
exempt the following drivers from the rule prohibiting drivers with
ITDM from driving CMVs in interstate commerce in 49 CFR 391.64(3):
    As of February 6, 2016, and in accordance with 49 U.S.C. 31136(e)
and 31315, the following 6 individuals have satisfied the renewal
conditions for obtaining an exemption from the rule prohibiting drivers
with ITDM from driving CMVs in interstate commerce (76 FR 79756; 77 FR
5873; 81 FR 1281):

Howard A. Betz (OH)
Kevin J. Coppens (ME)
Frank H. Ford, Jr. (PA)
Daniel R. Harris (TX)
Joseph L. Owings (AL)
Jerry H. Small (NC)

    The drivers were included in Docket No. FMCSA-2011-0326. Their
exemptions are effective as of February 6, 2016, and will expire on
February 6, 2018.
    As of February 10, 2016, and in accordance with 49 U.S.C. 31136(e)
and 31315, the following 6 individuals, have satisfied the renewal
conditions for obtaining an exemption from the rule prohibiting drivers
with ITDM from driving CMVs in interstate commerce (76 FR 78720; 77 FR
7232; 81 FR 1281):

Steve R. Fortunat (NJ)
Kenneth J. Hill (OH)
Cecil T. Keith (GA)
Frank E. Ray (KS)
Stanley L. Rybarcyzk (IL)
Gene A. Willias (WV)

    The drivers were included in Docket No. FMCSA-2011-0327. Their
exemptions are effective as of February 10, 2016, and will expire on
February 10, 2018.
    As of February 12, 2015, and in accordance with 49 U.S.C. 31136(e)
and 31315, the following individual, Guy B. Mayes (WA) has satisfied
the renewal conditions for obtaining an exemption from the rule
prohibiting drivers with ITDM from driving CMVs in interstate commerce
(78 FR 78479; 79 FR 13086; 81 FR 1281).
    The driver was included in Docket No. FMCSA-2013-0192. The
exemption is effective as of February 12, 2016, and will expire on
February 12, 2018.
    As of February 22, 2016, and in accordance with 49 U.S.C. 31136(e)
and 31315, the following 11 individuals have satisfied the renewal
conditions for obtaining an exemption from the rule prohibiting drivers
with ITDM from driving CMVs in interstate commerce (77 FR 533; 77 FR
10607; 81 FR 1281):

Garry L. Camden (IN)
Loren A. Cox (NY)
Darryl F. Gilbertson (WI)
Alfred Gutierrez II (OK)
Matthew D. Hulse (KS)
Neil E. Karvonen (WA)
Damon A. Kruger (CO)
Earl T. Morton, Jr. (VA)
Richard A. Norstebon (ND)
Donald J. Olbinski (IL)
Kevin E. Risley (IN)

    The drivers were included in Docket No. FMCSA-2011-0367. Their
exemptions are effective as of February 22, 2016, and will expire on
February 22, 2018.
    As of February 24, 2016, and in accordance with 49 U.S.C. 31136(e)
and 31315, the following 11 individuals have satisfied the renewal
conditions for obtaining an exemption from the rule prohibiting drivers
with ITDM from driving CMVs in interstate commerce (78 FR 68092; 79 FR
8182; 81 FR 1281):

Daniel C. Druffel (WA)
Gregory J. Godley (WA)
Troy A. Gortmaker (SD)
Charles M. Griswold (MA)
Justin R. Henneinke (CA)
William R. Huntley (MI)
Joseph I. Kulp (PA)
Kevin R. Mooney (WA)
Daniel D. Neale (CA)
Richard L. Sulzberger (IL)
Dirk Vanstralen (CA)

    The drivers were included in Docket No. FMCSA-2009-0294. Their
exemptions are effective as of February 24, 2016, and will expire on
February 24, 2018.
    As of February 27, 2015, and in accordance with 49 U.S.C. 31136(e)
and 31315, the following individual, Charles R. Clayton (NJ) has
satisfied the renewal conditions for obtaining an exemption from the
rule prohibiting drivers with ITDM from driving CMVs in interstate
commerce (78 FR 78479; 79 FR 13086; 81 FR 1281).
    The driver was included in Docket No. FMCSA-2013-0192. The
exemption is effective as of February 27, 2016, and will expire on
February 27, 2018.
    In accordance with 49 U.S.C. 31315, each exemption will be valid
for two years from the effective date unless revoked earlier by FMCSA.
The exemption will be revoked if the following occurs: (1) The person
fails to comply with the terms and conditions of the exemption; (2) the
exemption has resulted in a lower level of safety than was maintained
prior to being granted; or (3) continuation of the exemption would not
be consistent with the goals and objectives of 49 U.S.C. 31136 and
31315.

    Issued on: November 8, 2016.
Larry W. Minor,
Associate Administrator for Policy.
[FR Doc. 2016-27646 Filed 11-16-16; 8:45 am]
BILLING CODE 4910-EX-P


[Federal Register Volume 81, Number 186 (Monday, September 26, 2016)]
[Notices]
[Pages 66113-66114]
[FR Doc No: 2016-23045]

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SECURITIES AND EXCHANGE COMMISSION

[Release No. 34-78886; File No. SR-NASDAQ-2016-101]

Self-Regulatory Organizations; The NASDAQ Stock Market LLC; Order
Granting Approval of a Proposed Rule Change, as Modified by Amendment
Nos. 1 and 2, To Add Nasdaq Rule 7046 (Nasdaq Trading Insights)

September 20, 2016.

I. Introduction

    On July 26, 2016, The NASDAQ Stock Market LLC (``Nasdaq'' or
``Exchange'') filed with the Securities and Exchange Commission
(``Commission''), pursuant to Section 19(b)(1) of the Securities
Exchange Act of 1934 (``Act'') \1\ and Rule 19b-4 thereunder,\2\ a
proposed rule change to add Nasdaq Trading Insights, an optional market
data service composed of four market data components. The proposed rule
change was published for comment in the Federal Register on August 8,
2016.\3\ On August 15, 2016, the Exchange filed Amendment No. 1 to the
proposed rule change.\4\ On September 19, 2016, the Exchange filed
Amendment No. 2 to the proposed rule change.\5\ The Commission received
no comment letters on the proposed rule change. This order approves the
proposed rule change, as modified by Amendment Nos. 1 and 2.
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    \1\ 15 U.S.C. 78s(b)(1).
    \2\ 17 CFR 240.19b-4.
    \3\ See Securities Exchange Act Release No. 78462 (August 2,
2016), 81 FR 52486 (``Notice'').
    \4\ In Amendment No. 1, the Exchange revised the proposal to
specify that a subscribing market participant would receive all four
components of the Nasdaq Trading Insights product and would not be
able to elect to subscribe to fewer than all four components of the
product, as originally proposed. The Exchange also specified that
the fee for the product, to be implemented in a separate proposed
rule change, would be applicable to the full service and would not
be assessed per individual component, as originally proposed.
Because Amendment No. 1 does not materially alter the substance of
the proposed rule change or raise unique or novel regulatory issues,
Amendment No. 1 is not subject to notice and comment. Amendment No.
1 is available on the Commission's Web site at: https://www.sec.gov/comments/sr-nasdaq-2016-101/nasdaq2016101.shtml.
    \5\ In Amendment No. 2, the Exchange made a technical correction
to the proposed rule text to reflect the change it made in Amendment
No. 1 that eliminated the ability of market participants to elect to
subscribe to fewer than all four components of the Nasdaq Trading
Insights product. Because Amendment No. 2 is technical in nature,
Amendment No. 2 is not subject to notice and comment. Amendment No.
2 is available on the Commission's Web site at: https://www.sec.gov/comments/sr-nasdaq-2016-101/nasdaq2016101.shtml.
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II. Description of the Proposed Rule Change, as Modified by Amendment
Nos. 1 and 2

    The Exchange proposes to offer Nasdaq Trading Insights, a new
optional market data product that would be available to all of the
Exchange's participants for subscription.\6\ Nasdaq Trading Insights
would be composed of four market data components: (a) Missed
Opportunity--Liquidity; (b) Missed Opportunity--Latency; (c) Peer
Benchmarking; and (d) Liquidity Dynamics Analysis.\7\ All components of
Nasdaq Trading Insights would be offered on a T+1 basis.\8\
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    \6\ See Notice, supra note 3, at 52489.
    \7\ See proposed Rule 7046. See also Amendment No. 1, supra note
4 and Amendment No. 2, supra note 5. The Exchange will submit a
separate filing to address pricing for Nasdaq Trading Insights. See
Notice, supra note 3, at 52487 n.3.
    \8\ See Notice, supra note 3, at 52487-88.
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    The Missed Opportunity--Liquidity component would identify when an
order from a market participant could have been increased in size and
thus executed more shares.\9\ The data included in this component would
be unique for each subscribing market participant's port, and only that
market participant would be eligible to receive this data (i.e., a
market participant would not be able to obtain any other market
participant's data).\10\ According to the Exchange, the Missed
Opportunity--Liquidity component would provide greater visibility into
what was missed in trading so subscribing market participants may
improve their trading performance.\11\
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    \9\ See proposed Rule 7046(a)(1). The data elements for this
component, in summary, are: (i) Issue (Nasdaq symbol for the issue);
(ii) Buy/Sell Indicator (side of the market at which the market
participants are quoting); (iii) Price (the price (inclusive of
decimal point) at which Nasdaq Market Center market participants had
order interest for the given security at the given time); (iv) Order
Reference Number (the unique reference number assigned to the new
order at the time of receipt); (v) Order Entry Time Stamp (the time
order was received in the system); (vi) Share Quantity (total number
of shares submitted on original order); and (vii) Missed Opportunity
Quantity (total number of shares missed). See Notice, supra note 3,
at 52487 n.4.
    \10\ See Notice, supra note 3, at 52487.
    \11\ See id.
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    The Missed Opportunity--Latency component would identify by how
much time a marketable order missed executing a resting order that was
cancelled or executed.\12\ The data included in this component would be
based only on the data of the subscribing market participant, and a
market participant would not be able to receive another market
participant's data.\13\ According to the Exchange, as with the Missed
Opportunity--Liquidity component, this component would provide greater
visibility into what was missed in trading so subscribing market
participants may improve their trading performance.\14\
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    \12\ See proposed Rule 7046(a)(2). The data elements for this
component, in summary, are: (i) Issue (Nasdaq symbol for the issue);
(ii) Buy/Sell Indicator (side of the market at which the market
participants are quoting); (iii) Price (the price (inclusive of
decimal point) at which Nasdaq Market Center market participants had
order interest for the given security at the given time); (iv) Order
Reference Number (the unique reference number assigned to the new
order at the time of receipt); (v) Order Size; (vi) Matching Engine
times for incoming orders; (vii) Missed Opportunity times; and
(viii) Reasons for not getting fills. See Notice, supra note 3, at
52487 n.5. The Missed Opportunity--Latency component would not
provide specific information about resting orders on the Exchange
order book. See id. at 52487.
    \13\ See Notice, supra note 3, at 52487.
    \14\ See id.
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    The Peer Benchmarking component would rank the quality of a market
participant's trading performance against its peers trading on
Nasdaq.\15\ Market participants would be able to view their own trading
activity broken out by port with each being ranked independently for
each metric against their peers.\16\ The data included in this

component would be specific to a subscribing market participant's port
and a market participant would not be able to receive another market
participant's data.\17\ According to the Exchange, this component would
help subscribing market participants to have a better idea of how their
competitors are performing vis-[agrave]-vis their own trading.\18\
Moreover, according to the Exchange, this component would help
subscribing market participants to better understand trending over
time, their ranking, and whether their behavioral changes translate
into expected results.\19\
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    \15\ See proposed Rule 7046(a)(3). The data elements for this
component, in summary, include: (i) Total Dollar Volume; (ii) Total
Share Volume, Share Volume of Liquidity Provision and Accessible for
Tape A, Tape B and Tape C; (iii) Number of Trades, including Hidden
Orders and Number of Hidden Trades; (iv) Mean/Median Trade Size; (v)
Mean/Median Size of Hidden Orders; (vi) Number of Buy/Sell Orders
Received; (vii) Number of Aggressive Orders, Mean Size of Aggressive
Buy/Sell Orders; (viii) Number of Passive Orders, Mean Size of
Displayed Passive Order, Hidden Passive for Buy and Sell Orders;
(ix) Number of Orders at Best Bid/Ask Level; (x) Mean Cost to
Execute for Buy and Sell for 1000, 5000, 10000 Shares; (xi) Number
of Modified/Cancelled Buy/Sell Orders; (xii) Mean Buy/Sell Price
Range; (xiii) Total Number of Buy/Sell Price; (xiv) Number, Mean--
Resting Buy/Sell Price Points; (xv) Missed Opportunities--Liquidity,
Latency; (xvi) Mean Share Volume Against Hidden, Mean Quote Rotation
Time. See Notice, supra note 3, at 52487 n.6.
    \16\ See Notice, supra note 3, at 52487-88. Each port would be
categorized into a peer grouping that would be based upon a given
set of metrics that would share similar trading behavior
characteristics, and there would be at least ten peers within a
security. See id. at 52488.
    \17\ See id. at 52488.
    \18\ See id.
    \19\ See id.
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    The Liquidity Dynamics Analysis component would contain historical
aggregated metrics and statistics regarding displayed and hidden
liquidity on the Exchange for NMS securities listed on Nasdaq, the New
York Stock Exchange, and other U.S. equity exchanges.\20\ The data
would be analyzed every 30 seconds, starting at 10 minutes prior to the
market open to 10 minutes after the market close, and it would include
all orders that are visible, anonymous, or non-displayed for each
security.\21\ According to the Exchange, subscribing market
participants may use this component to better understand when
accessible liquidity exists, which may help these market participants
improve their trading performance.\22\
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    \20\ See proposed Rule 7046(a)(4) and Notice, supra note 3, at
52488. The data elements for this component, in summary, are: (i)
Issue (Nasdaq symbol for the issue); (ii) Start Time; (iii) End
Time; (iv) Side (identifies buy vs. sell side); (v) Level (level
associated with the price); (vi) Average Depth (average depth of the
book); (vii) Minimum Depth (minimum depth of the book); (viii)
Maximum Depth (maximum depth of the book); (ix) Standard Deviation
Depth; (x) Average Price; (xi) Minimum Price (minimum price in the
book); (xii) Maximum Price (maximum price in the book); (xiii)
Median Price (median price in the book); (xiv) Standard Deviation--
Price; (xv) Minimum Distance from the QBBO; (xvi) Maximum Distance
from the QBBO; (xvii) Mean Distance from the QBBO; (xviii) Median
Distance from the QBBO; and (xix) Standard Deviation-Distance from
QBBO. See Notice, supra note 3, at 52488 n.7. This component would
include statistics regarding quantity and price at each of the top
five price levels per buy/sell side and per stated time period. See
proposed Rule 7046(a)(4).
    \21\ See Notice, supra note 3, at 52488.
    \22\ See id. For a more detailed description of the proposed
rule change, see Notice, supra note 3; Amendment No. 1, supra note
4; and Amendment No. 2, supra note 5.
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III. Discussion and Commission Findings

    The Commission finds that the proposed rule change, as modified by
Amendment Nos. 1 and 2, is consistent with the requirements of the Act
and the rules and regulations thereunder applicable to a national
securities exchange.\23\ In particular, the Commission finds that the
proposal is consistent with Section 6(b)(5) of the Act,\24\ which
requires, among other things, that the rules of a national securities
exchange be designed to promote just and equitable principles of trade,
to remove impediments to and perfect the mechanism of a free and open
market and a national market system and, in general, to protect
investors and the public interest.
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    \23\ In approving this proposed rule change, the Commission
notes that it has considered the proposed rule's impact on
efficiency, competition, and capital formation. See 15 U.S.C.
78c(f).
    \24\ 15 U.S.C. 78f(b)(5).
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    As noted above, Nasdaq Trading Insights would be an optional market
data product available to all of the Exchange's participants for
subscription, and would be designed to provide additional information
and insight to subscribing market participants regarding their trading
activity on the Exchange.\25\ Also, as noted above, Nasdaq Trading
Insights would not be a real-time market data product and would be
provided to subscribers on a T+1 basis.\26\ Moreover, where Nasdaq
Trading Insights data is specific to one market participant, only that
market participant would receive such data.\27\ According to the
Exchange, some market participants may already be able to derive the
same data that is provided by some of the Nasdaq Trading Insights
components based on executions and algorithms that those market
participants have created.\28\ As the Exchange noted, Nasdaq Trading
Insights would increase transparency, particularly for market
participants who may not have the expertise to generate the same
information.\29\
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    \25\ See supra notes 6, 11, 14, 18, 19, and 22, and accompanying
text. See also Notice, supra note 3, at 52487.
    \26\ See supra note 8 and accompanying text.
    \27\ See supra notes 10, 13, and 17, and accompanying text.
    \28\ See Notice, supra note 3, at 52489.
    \29\ See id. at 52487.
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    Based on the Exchange's representations with respect to the Nasdaq
Trading Insights product and for the foregoing reasons, the Commission
finds that the proposed rule change, as modified by Amendment Nos. 1
and 2, is consistent with the Act.

IV. Conclusion

    It is therefore ordered, pursuant to Section 19(b)(2) of the
Act,\30\ that the proposed rule change (SR-NASDAQ-2016-101), as
modified by Amendment Nos. 1 and 2, be, and hereby is, approved.
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    \30\ 15 U.S.C. 78s(b)(2).

    For the Commission, by the Division of Trading and Markets,
pursuant to delegated authority.\31\
---------------------------------------------------------------------------

    \31\ 17 CFR 200.30-3(a)(12).
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Robert W. Errett,
Deputy Secretary.
[FR Doc. 2016-23045 Filed 9-23-16; 8:45 am]
 BILLING CODE 8011-01-P


[Federal Register Volume 81, Number 121 (Thursday, June 23, 2016)]
[Proposed Rules]
[Pages 40834-40838]
[FR Doc No: 2016-14806]

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ENVIRONMENTAL PROTECTION AGENCY

40 CFR Parts 52 and 81

[EPA-R05-OAR-2011-0698; FRL-9948-00-Region 5]

Approval and Promulgation of Air Quality Implementation Plans;
Indiana; Redesignation of the Indiana Portion of the Louisville Area to
Attainment of the 1997 Annual Standard for Fine Particulate Matter

AGENCY: Environmental Protection Agency (EPA).

ACTION: Proposed rule; supplemental.

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SUMMARY: The Environmental Protection Agency (EPA) is issuing a
supplement to its July 11, 2013, proposed approval of Indiana's request
to redesignate the Indiana portion of the Louisville, Indiana-Kentucky,
area to attainment for the 1997 annual national ambient air quality
standard (NAAQS or standard) for fine particulate matter
(PM2.5). After EPA's proposed redesignation in 2013, an
audit of the Kentucky monitoring program identified problems which
invalidated monitoring data for 2012 and the beginning of 2013. Because
of this invalid data, the area could not meet the requirement that the
entire area must demonstrate attainment of the standard using the most
current three years of data. This supplemental proposal provides new
quality-assured, quality-controlled data for the most recent three
years of data showing that the entire area attains the 1997
PM2.5 standard. In the supplemental proposal EPA is
proposing that the entire Louisville area is attaining the 1997
PM2.5 NAAQS based on the most recent three years of data.
EPA also discusses the maintenance plan out-year emission projections,
and the Cross-State Air Pollution Rule (CSAPR) remanded budgets impact
on the Louisville area--because the status of these issues has changed
from the initial proposal to now. EPA is seeking comment only on the
issues raised in this supplemental proposal, and is not re-opening for
comment other issues raised in the July 11, 2013, proposed approval.

DATES: Comments must be received on or before July 25, 2016.

ADDRESSES: Submit your comments, identified by Docket ID No. EPA-R05-
OAR-2011-0698 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: Carolyn Persoon, Environmental
Engineer, Control Strategies 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 for the supplemental proposal?
II. On what specific issues is EPA taking comment?
    A. Louisville Area Design Values for 2013-2015; Entire Area
Monitoring Attainment
    B. Demonstration of Maintenance
    C. CAIR and CSAPR
III. Summary of Proposed Actions
IV. Statutory and Executive Order Reviews

I. What is the background for the supplemental proposal?

    On June 16, 2011, the Indiana Department of Environmental
Management (IDEM) submitted a request for EPA to approve the
redesignation of the Indiana portion of the Louisville (KY-IN) (Madison
Township, Indiana, Jefferson County, Kentucky and Clark and Floyd
Counties, Indiana) nonattainment area to attainment of the 1997
PM2.5 annual standard. Indiana's June 16, 2011,
redesignation submittal contained complete, quality-assured and
certified air monitoring data for the years 2008-2010.
    On July 11, 2013, EPA proposed to determine that the Indiana
portion of the Louisville area had met the requirements for
redesignation under section 107(d)(3)(E) of the Clean Air Act (CAA) (78
FR 41735). This proposal was based upon our review of ambient air
monitoring data from 2009-2011, and preliminary data from 2012. It
contained several related actions.
    First, EPA proposed to approve the request from IDEM to change the
legal designation of the Indiana portion of the Louisville area from
nonattainment to attainment for the 1997 annual PM2.5 NAAQS.
EPA also proposed to approve Indiana's PM2.5 maintenance
plan for the Indiana portion of the Louisville area as a revision to
the Indiana state implementation plan (SIP) because the plan met the
requirements of section 175A of the CAA. In addition, EPA proposed to
approve emissions inventories for primary PM2.5, and all its
precursors as satisfying the requirement in section 172(c)(3) of the
CAA for a comprehensive, current emission inventory. Finally, EPA
proposed a

motor vehicle emissions budget for the Indiana portion of the
Louisville area. EPA did not receive adverse comments on the proposed
rulemaking.
    In August 2013, EPA issued results of a technical systems audit on
the PM2.5 laboratory in Kentucky, which invalidated the
Jefferson County monitoring data for all of 2012, and a small portion
of the monitoring data from 2013 (a portion of the first quarter). See
the docket for the technical systems audit information. Since the area
could no longer demonstrate attainment of the standard for the entire
area, EPA did not finalize its proposal. Kentucky began collecting
valid data in early 2013 (the end of the first quarter) after the
monitoring audit issues had been addressed, resulting in a valid design
value for the area using 2013-2015 data. Both Indiana and Kentucky
certified valid data for 2015 in the beginning of 2016. EPA has
approved the use of this quality-assured, quality-controlled certified
complete data for use in regulatory actions.
    Today, EPA is publishing a supplement to its July 11, 2013,
proposed rulemaking. The supplement is based on valid design values for
the 2013-2015 period, demonstrating attainment of the standard for the
entire Louisville area using the most recent three years of data.
Preliminary data for 2016 shows that the entire Louisville area
continues to attain the standard. This proposal also discusses the
maintenance plan emission projections of 2025 and the impact of the
budgets remanded under CSAPR on the Louisville area because the status
of these issues has changed from the initial proposal.

II. On what specific issues is EPA taking comments?

    In this portion of EPA's supplemental proposal, EPA is soliciting
comment on the limited issue of the 2013-2015 design values
demonstrating attainment of the standard for the entire Louisville
area, the maintenance plan emission projections for 2025, and the
impact on the Louisville area of the 2015 D.C. Circuit decision
remanding certain CSAPR budgets.

A. Louisville Area Design Values for 2013-2015; Entire Area Monitoring
Attainment

    EPA is proposing to determine that the Louisville area is attaining
the 1997 annual PM2.5 NAAQS based upon the most recent three
years of complete, certified and quality-assured data. Under EPA's
regulations at 40 CFR 50.7, the annual primary and secondary
PM2.5 standards are met when the annual arithmetic mean
concentration, as determined in accordance with 40 CFR part 50,
appendix N, is less than or equal to 15.0 micrograms per cubic
meter([micro]g/m\3\)at all monitoring sites in the area. Data are
considered to be sufficient for comparison to the NAAQS if three
consecutive complete years of data exist. A complete year of air
quality data is comprised of four calendar quarters, with each quarter
containing data from at least 75% capture of the scheduled sampling
days. In this case, the 2009-2011 values were calculated prior to the
audit invalidating data collected in the Kentucky portion of Louisville
for 2012 and beginning of 2013 (portion of the first quarter). The
2013-2015 values are based on quality-assured, quality-controlled,
certified complete data, and only included valid data collected after
the audit issues were corrected. Preliminary data for 2016 shows the
area continues to attain the standard. The Louisville design value for
the most current three years of data is 11.7 [mu]g/m\3\.

Table 1--The 1997 Annual PM2.5 Design Values for the Louisville Monitor With Complete Data for the 2009-2011,\1\
                                   and 2013-2015 Design Value in [micro]g/m\3\
----------------------------------------------------------------------------------------------------------------
                                                                                Design value    Design value
                             County                                    Site          2009-2011       2013-2015
                                                                                ([mu]g/m\3\)    ([mu]g/m\3\)
----------------------------------------------------------------------------------------------------------------
Clark County, IN................................................       180190006            13.5            11.4
Clark County, IN................................................       180190008            11.4             9.3
Floyd County, IN................................................       180431004            12.3            10.0
Jefferson County, KY............................................       211110043            12.6            11.3
Jefferson County, KY............................................       211110051            12.7            11.7
Jefferson County, KY............................................       211110067            12.1            10.5
----------------------------------------------------------------------------------------------------------------
\1\ 2009-2011 design values are the desigh values for the area prior to date issues, and design values for 2013-
  2015 are the most recent three years of monitoring data showing that the area is attaining the standard.

    Data recorded at monitors in 2013, 2014, and 2015 are considered
valid and were collected after corrective actions resulting from the
technical systems audit. These are the data on which EPA is basing its
decision that the Louisville area has attained the 1997 annual
PM2.5 NAAQS.

B. Demonstration of Maintenance

    Along with the redesignation request, Indiana submitted a revision
to its PM2.5 SIP to include a maintenance plan for the
Indiana portion of the Louisville area, as required by section 175A of
the CAA. Indiana's plan demonstrates maintenance of the 1997 annual
PM2.5 standard through 2025 by showing that current and
future emissions of oxides of nitrogen (NOX), directly
emitted PM2.5, and sulfur dioxide (SO2) in the
area remain at or below attainment year emission levels. Section 175A
requires a state seeking redesignation to attainment to submit a SIP
revision which provides for the maintenance of the NAAQS in the area
``for at least 10 years after the redesignation.'' See September 4,
1992, memorandum from John Calcagni, entitled ``Procedures for
Processing Requests to Redesignate Areas to Attainment,'' p. 9. Where
the emissions inventory method of showing maintenance is used, its
purpose is to show that emissions during the maintenance period will
not increase over the attainment year inventory. Calcagni Memorandum,
pp. 9-10.
    As discussed in detail in the section below, the state's
maintenance plan submission expressly documents that the area's
emissions inventories will remain below the attainment year inventories
through 2025. In addition, for the reasons set forth below, EPA
believes that the state's submission, in conjunction with additional
supporting information, further demonstrates that the area will
continue to maintain the PM2.5 standard at least through
2026. Thus, if EPA finalizes its proposed approval of the redesignation
request and maintenance plan in 2016, it will be based on a showing, in
accordance with section 175A, that the state's maintenance plan
provides for

maintenance for at least ten years after redesignation.
    Indiana's plan demonstrates maintenance of the 1997 annual
PM2.5 NAAQS through 2025 by showing that current and future
emissions of NOX, directly emitted PM2.5 and
SO2 for the area remain at or below attainment year emission
levels.
    The rate of decline in emissions of PM2.5,
NOX, and SO2 from the attainment year 2008
through 2025 (calculated from Table 2) indicates that emissions
inventory levels not only significantly decline between 2008 and 2025,
but that the reductions will continue in 2026 and beyond. The average
annual rate of decline is 4,472 tons per year (tpy) for SO2,
1,052 tpy of NOX, and 8.73 tpy of direct PM for the Indiana
portion of the Louisville area, and average annual rate of decline is
4,436 tpy for SO2, 2,239 tpy of NOX, and 98.1 tpy
of direct PM for the entire Louisville area. These rates of decline are
consistent with monitored and projected air quality trends, emissions
reductions achieved through emissions controls and regulations that
will remain in place beyond 2026 and through fleet turnover that will
continue beyond 2026, among other factors. We are proposing to find the
mobile source contribution to these emissions is expected to remain
insignificant in 2026 and beyond because of fleet turnover in upcoming
years that will result in cleaner vehicles and cleaner fuels.
    A maintenance demonstration need not be based on modeling. See Wall
v. EPA, 265 F.3d 426 (6th Cir. 2001), Sierra Club v. EPA, 375 F. 3d 537
(7th Cir. 2004). See also 66 FR 53094, 53099-53100 (October 19, 2001),
68 FR 25413, 25430-25432 (May 12, 2003), 78 FR 53272 (August 29, 2013).
Indiana uses emissions inventory projections for the years 2015 and
2025 to demonstrate maintenance for the entire Louisville area. The
projected emissions were estimated by Indiana, with assistance from the
Lake Michigan Air Directors Consortium (LADCO) and the Kentucky
Regional Planning and Development Agency (KIPDA), who used the
MOVES2010a model for mobile source projections. Projection modeling of
inventory emissions was done for the 2015 interim year emissions using
estimates based on the 2008 and 2015 LADCO modeling inventory, using
LADCO's growth factors, for all sectors. The 2025 maintenance year
emission estimates were based on emissions estimates from the 2015
LADCO modeling. Table 2 shows the 2008 attainment base year emission
estimates and the 2015 and 2025 emission projections for the Louisville
area, taken from Indiana's June 16, 2011, submission.

  Table 2--Comparison of 2008, 2015 and 2025 NOX, Direct PM2.5 and SO2 Emission Totals (tpy) for the Louisville
                                                      Area
----------------------------------------------------------------------------------------------------------------
                                              SO2                        NOX                      PM2.5
----------------------------------------------------------------------------------------------------------------
2008 (baseline)..................  151,503.01...............  97,533.93...............  6,724.02.
2015.............................  76,958.54................  69,936.67...............  5,540.29.
2025.............................  76,082.07................  59,455.17...............  5,055.61.
Change 2008-2025.................  -75,420.94...............  -38,078.76..............  -1,668.41.
                                   50% decrease.............  39% decrease............  25% decrease.
----------------------------------------------------------------------------------------------------------------

    Table 2 shows that, for the period between 2008 and the maintenance
projection for 2025, the Louisville area will reduce NOX
emissions by 38,078 tpy; direct PM2.5 emissions by 1,668
tpy; and SO2 emissions by 75,420 tpy. The 2025 projected
emissions levels are significantly below attainment year inventory
levels, and, based on the rate of decline, it is highly improbable that
any increases in these levels will occur in 2026 and beyond. Thus, the
emissions inventories set forth in Table 2 show that the area will
continue to maintain the annual PM2.5 standards during the
maintenance period and at least through 2026.
    As Table 1 and 2 demonstrate, monitored PM2.5 design
value concentrations in the Louisville area are well below the NAAQS in
the years beyond 2008, an attainment year for the area. Further, those
values are trending downward as time progresses. Based on the future
projections of emissions in 2025 showing significant emissions
reductions in direct PM2.5, NOX, and
SO2, it is very unlikely that monitored PM2.5
values in 2026 and beyond will show violations of the NAAQS.
Additionally, the 2013-2015 design value of 11.7 [mu]g/m\3\ provides a
sufficient margin for the 1997 standard in the unlikely event emissions
rise slightly in the future.

C. CAIR and CSAPR

    In its redesignation request and maintenance plan, the state
identified the Clean Air Interstate Rule (CAIR) as a permanent and
enforceable measure that contributed to attainment in the Louisville
Area. CAIR created regional cap-and-trade programs to reduce
SO2 and NOX emissions in 27 eastern states,
including Indiana, that contributed to downwind nonattainment or
interfered with maintenance of the 1997 8-hour ozone NAAQS and the 1997
PM2.5 NAAQS. See 70 FR 25162 (May 12, 2005). Indiana adopted
CAIR budgets into its SIP on November 1, 2006, with emission reductions
beginning in 2010 and extending into 2015. By 2007, the beginning of
the attainment time period identified by Indiana, CAIR had begun
achieving emission reductions in the state.
    In 2008, the United States Court of Appeals for the District of
Columbia Circuit (D.C. Circuit) vacated CAIR, North Carolina v. EPA,
531 F.3d 896 (D.C. Cir. 2008); but ultimately remanded the rule to EPA
without vacatur to preserve the environmental benefits provided by
CAIR, North Carolina v. EPA, 550 F.3d 1176, 1178 (D.C. Cir. 2008). On
August 8, 2011 (76 FR 48208), acting on the D.C. Circuit's remand, EPA
promulgated CSAPR to replace CAIR and, thus, to address the interstate
transport of emissions contributing to nonattainment and interfering
with maintenance of the two air quality standards covered by CAIR as
well as the 2006 PM2.5 NAAQS. CSAPR requires substantial
reductions of SO2 and NOX emissions from emission
generating units (EGUs) in 28 states in the eastern United States. As a
general matter, because CSAPR is CAIR's replacement, emissions
reductions associated with CAIR will for most areas be made permanent
and enforceable through implementation of CSAPR.
    Numerous parties filed petitions for review of CSAPR in the D.C.
Circuit, and on August 21, 2012, the court issued its ruling, vacating
and remanding CSAPR to EPA and ordering continued implementation of
CAIR. EME Homer City Generation, L.P. v. EPA, 696 F.3d 7, 38 (D.C. Cir.
2012). The D.C. Circuit's vacatur of CSAPR was reversed by the United
States Supreme Court on April 29, 2014, and the case was remanded to
the D.C. Circuit to resolve remaining issues in accordance with the
high court's ruling. EPA v. EME

Homer City Generation, L.P., 134 S. Ct. 1584 (2014). On remand, the
D.C. Circuit affirmed CSAPR in most respects, but invalidated without
vacating some of the CSAPR budgets as to a number of states. EME Homer
City Generation, L.P. v. EPA, 795 F.3d 118 (D.C. Cir. 2015) (EME Homer
City II). The Phase 2 annual and ozone season NOX and
SO2 budgets for Indiana are not affected by the Court's
decision. The litigation over CSAPR ultimately delayed implementation
of that rule for three years, from January 1, 2012, when CSAPR's cap-
and-trade programs were originally scheduled to replace the CAIR cap-
and-trade programs, to January 1, 2015. CSAPR's Phase 2 budgets were
originally promulgated to begin on January 1, 2014, and are now
scheduled to begin on January 1, 2017. CSAPR will continue to operate
under the existing emissions budgets until EPA addresses the D.C.
Circuit's remand. The Court's decision did not affect Indiana's CSAPR
emissions budgets; therefore, CSAPR ensures that the NOX and
SO2 emissions reductions associated with CAIR and CSPAR
throughout Indiana are permanent and enforceable.\1\
---------------------------------------------------------------------------

    \1\ 2009-2011 design values are the design values for the area
prior to data issues, and design values for 2013-2015 are the most
recent three years of monitoring data showing that the area is
attaining the standard.
---------------------------------------------------------------------------

    In its redesignation request, Indiana noted that a number of states
contributed to PM2.5 concentrations in the Louisville area
based on EPA air quality modeling. Additionally, an air quality
modeling analysis conducted by IDEM demonstrates that the Louisville
area would be able to attain the PM2.5 standard even in the
absence of either CAIR or CSAPR. See appendices H and I of Indiana's
redesignation request found in the docket. This modeling is available
in the docket for this proposed redesignation action.
    To the extent that Louisville relies on CSAPR for maintenance of
the standard, EPA has identified the Louisville area as having been
significantly impacted by pollution transported from other states in
both CAIR and CSAPR, and these rules greatly reduced the tons of
SO2 and NOX emissions generated in the states
upwind of the area. The air quality modeling performed for the CSAPR
rulemaking identified the following states as having contributed to
PM2.5 concentrations in the Louisville area: Illinois,
Indiana, Kentucky, Michigan, Missouri, Ohio, Pennsylvania, Tennessee,
West Virginia and Wisconsin. See 76 FR 48208(August 8, 2011). Even
though the first phase of CAIR implementation for SO2 did
not begin until 2010, many sources began reducing their emissions well
in advance of the first compliance deadline because of the incentives
offered by CAIR for early compliance with the rule. The emission
reductions in the states upwind of the Louisville area achieved by
CAIR, and made permanent by CSAPR, are unaffected by the D.C. Circuit's
remand of CSAPR.\2\
---------------------------------------------------------------------------

    \2\ The D.C. Circuit in EME Homer City II remanded the
SO2 trading program budgets for four states, none of
which were identified as contributing to the Louisville area.
Moreover, updated air quality modeling performed for the CSAPR
identified that the Louisville area can attain and maintain the 1997
PM2.5 NAAQS and no modeled issues for the 2012 NAAQS 76
FR 48207, 48241 (August 8, 2011) and Page memo, March 17, 2016.
---------------------------------------------------------------------------

III. Summary of Proposed Actions

    EPA is issuing a supplement to its action, published July 11, 2013,
which proposed to redesignate the Indiana portion of the Louisville
area to attainment for the 1997 annual PM2.5 NAAQS, to
approve the associated maintenance plan, and to approve the state's
emission inventory. EPA is concluding that the most current three year
design values show that the area is attaining the standard and
preliminary values show the area continues to attain the 1997 annual
PM2.5 NAAQS. EPA also determined that the projections used
in the states submittal meet the requirements of the maintenance plan
out-year emission projections. EPA concluded that the CSAPR remanded
budgets did not affect the area's ability to attain through permanent
and enforceable measures and will not affect the area's ability to
maintain the standard. EPA is seeking comment only on the issues raised
in this supplemental proposal, and is not re-opening comment on other
issues addressed in its prior proposal.

IV. Statutory and Executive Order Reviews

    Under the CAA, redesignation of an area to attainment and the
accompanying approval of a maintenance plan under section 107(d)(3)(E)
are actions that affect the status of a geographical area and do not
impose any additional regulatory requirements on sources beyond those
imposed by state law. A redesignation to attainment does not in and of
itself create any new requirements, but rather results in the
applicability of requirements contained in the CAA for areas that have
been redesignated to attainment. Moreover, 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, these proposed actions do not impose additional
requirements beyond those imposed by state law and the CAA. For that
reason, these proposed actions:
     Are not ``significant regulatory actions'' 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);
     Do not impose an information collection burden under the
provisions of the Paperwork Reduction Act (44 U.S.C. 3501 et seq.);
     Are 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.);
     Do 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);
     Do not have Federalism implications as specified in
Executive Order 13132 (64 FR 43255, August 10, 1999);
     Are not economically significant regulatory actions based
on health or safety risks subject to Executive Order 13045 (62 FR
19885, April 23, 1997);
     Are not significant regulatory actions subject to
Executive Order 13211 (66 FR 28355, May 22, 2001);
     Are 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
     Do not provide EPA with the discretionary authority to
address, as appropriate, disproportionate human health or environmental
effects, using practicable and legally permissible methods, under
Executive Order 12898 (59 FR 7629, February 16, 1994).
    In addition, this proposed rule does not have tribal implications
as specified by Executive Order 13175 (65 FR 67249, November 9, 2000),
because a determination of attainment is an action that affects the
status of a geographical area and does not impose any new regulatory
requirements on tribes, impact any existing sources of air pollution on
tribal lands, nor impair the maintenance of ozone national ambient air
quality standards in tribal lands.

List of Subjects

40 CFR Part 52

    Environmental protection, Air pollution control, Incorporation by

reference, Intergovernmental relations, Particulate matter.

40 CFR Part 81

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

    Dated: June 1, 2016.
Robert A. Kaplan,
Acting Regional Administrator, Region 5.
[FR Doc. 2016-14806 Filed 6-22-16; 8:45 am]
 BILLING CODE 6560-50-P