[Federal Register Volume 79, Number 33 (Wednesday, February 19, 2014)]
[Notices]
[Pages 9522-9523]
[FR Doc No: 2014-03565]

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SECURITIES AND EXCHANGE COMMISSION

[Release No. 34-71535; File No. SR-Phlx-2014-011]

Self-Regulatory Organizations; NASDAQ OMX PHLX LLC; Notice of
Filing and Immediate Effectiveness of Proposed Rule Change To Modify
NASDAQ OMX PSX's Optional Anti-Internalization Functionality

February 12, 2014.
    Pursuant to Section 19(b)(1) of the Securities Exchange Act of 1934
(``Act''),\1\ and Rule 19b-4 thereunder,\2\ notice is hereby given that
on February 4, 2014, NASDAQ OMX PHLX LLC (``Phlx'' or ``Exchange'')
filed with the Securities and Exchange Commission (``SEC'' or
``Commission'') the proposed rule change as described in Items I, II,
and III below, which Items have been prepared by the Exchange. The
Commission is publishing this notice to solicit comments on the
proposed rule change from interested persons.
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    \1\ 15 U.S.C. 78s(b)(1).
    \2\ 17 CFR 240.19b-4.
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I. Self-Regulatory Organization's Statement of the Terms of Substance
of the Proposed Rule Change

    The Exchange proposes to modify the optional anti-internalization
functionality of NASDAQ OMX PSX (``PSX'').
    The text of the proposed rule change is available on the Exchange's
Web site at http://nasdaqomxphlx.cchwallstreet.com/, at the principal
office of the Exchange, and at the Commission's Public Reference Room.

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

    In its filing with the Commission, the Exchange included statements
concerning the purpose of and basis for the proposed rule change and
discussed any comments it received on the proposed rule change. The
text of these statements may be examined at the places specified in
Item IV below. The Exchange has prepared summaries, set forth in
sections A, B, and C below, of the most significant aspects of such
statements.

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

1. Purpose
    Phlx is proposing to modify PSX's voluntary anti-internalization
functionality to provide an additional option under that functionality.
In addition, the proposed rule change contains certain clarifications
to the text of the rule. Anti-internalization functionality is designed
to assist market participants in complying with certain rules and
regulations of the Employee Retirement Income Security Act (``ERISA'')
that preclude and/or limit broker-dealers managing accounts governed by
ERISA from trading as principal with orders generated for those
accounts. The functionality can also assist market participants in
avoiding execution fees that may result from the interaction of
executable buy and sell trading interest from the same firm. Phlx notes
that use of the functionality does not relieve or otherwise modify the
duty of best execution owed to orders received from public customers.
As such, market participants using anti-internalization functionality
will need to take appropriate steps to ensure that public customer
orders that do not execute because of the use of anti-internalization
functionality ultimately receive the same execution price (or better)
they would have originally obtained if execution of the order was not
inhibited by the functionality.
    Currently, market participants may apply anti-internalization logic
to all quotes/orders entered through a particular MPID, or to all
orders entered through a particular order entry port, to which a unique
group identification modifier is then appended. In other words, the
logic may be applied on an MPID-by-MPID, or on a port-by-port basis.\3\
Currently, two forms of anti-internalization logic may be applied: (i)
If quotes/orders are equivalent in size, both quotes/orders will be
cancelled, or if they are not equivalent in size, the smaller will be
cancelled and the size of the larger will be reduced by the size of the
smaller; or (ii) regardless of the size of the quotes/orders, the
oldest quote/order will be cancelled in full. The applicable logic may
be applied to an entire MPID, or alternatively, different logic may be
applied to different order entry ports under a particular MPID.\4\
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    \3\ In the proposed rule change that introduced the ability to
assign a group identification modifier with respect to anti-
internalization processing, Phlx stated that the modifier may be
assigned ``at the port level.'' Securities Exchange Act Release No.
65869 (December 2, 2011), 76 FR 76793 (December 8, 2011) (SR-Phlx-
2011-080). However, this level of specificity was not included in
the text of Rule 3307. In addition, although the rule indicates that
designation of functionality at the port level is an option
available to the market participant, the rule does not make it clear
that in order to make use of these options, market participants must
use PSX's OUCH order entry protocol. Thus, the proposed rule change
also adds additional specificity to the rule text with respect to
these aspects of the anti-internalization functionality.
    \4\ With respect to this functionality also, participants
wishing to make designations on the order port level must use the
OUCH order entry protocol.
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    In response to member input, the proposed rule change will add an
additional form of anti-internalization logic that a market participant
could choose to apply, under which the most recent quote/order would be
cancelled. As with the two existing forms of anti-internalization
logic, the logic could be applied to an entire MPID, or to selected
order entry ports under a particular MPID.\5\ Phlx believes that the
change will provide members with an additional tool for managing the
book of orders that they submit to PSX and the associated execution
costs.
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    \5\ Id.
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2. Statutory Basis
    Phlx believes that the proposed rule change is consistent with the
provisions of Section 6 of the Act,\6\ in general, and with Section
6(b)(5) of the Act \7\ in particular, in that the proposal is designed
to prevent fraudulent and manipulative acts and practices, to promote
just and equitable principles of

trade, to foster cooperation and coordination with persons engaged in
regulating, clearing, settling, processing information with respect to,
and facilitating transactions in securities, 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. Specifically, Phlx believes that the change, which is
responsive to member input, will facilitate transactions in securities
and perfect the mechanism of a free and open market by providing
members with additional optional functionality that may assist them
with managing the book of orders that they submit to PSX and the
associated execution costs.
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    \6\ 15 U.S.C. 78f.
    \7\ 15 U.S.C. 78f(b)(5).
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B. Self-Regulatory Organization's Statement on Burden on Competition

    Phlx does not believe that the proposed rule change will result in
any burden on competition that is not necessary or appropriate in
furtherance of the purposes of the Act, as amended. Specifically, by
offering market participants additional options with regard to
preventing inadvertent internalization of orders submitted to PSX, the
change has the potential to enhance PSX's competitiveness with respect
to other trading venues, thereby promoting greater competition.
Moreover, the change does not burden competition in that its use is
optional and provided at no additional cost to members.

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

    No written comments were either solicited or received.

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

    Because the foregoing proposed rule change does not: (i)
Significantly affect the protection of investors or the public
interest; (ii) impose any significant burden on competition; and (iii)
become operative for 30 days from the date on which it was filed, or
such shorter time as the Commission may designate, it has become
effective pursuant to Section 19(b)(3)(A)(ii) of the Act \8\ and
subparagraph (f)(6) of Rule 19b-4 thereunder.\9\
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    \8\ 15 U.S.C. 78s(b)(3)(a)(ii).
    \9\ 17 CFR 240.19b-4(f)(6). In addition, Rule 19b-4(f)(6)
requires a self-regulatory organization to give the Commission
written notice of its intent to file the proposed rule change at
least five business days prior to the date of filing of the proposed
rule change, or such shorter time as designated by the Commission.
The Exchange has satisfied this requirement.
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    At any time within 60 days of the filing of the proposed rule
change, the Commission summarily may temporarily suspend such rule
change if it appears to the Commission that such action is: (i)
necessary or appropriate in the public interest; (ii) for the
protection of investors; or (iii) otherwise in furtherance of the
purposes of the Act. If the Commission takes such action, the
Commission shall institute proceedings to determine whether the
proposed rule should be approved or disapproved.

IV. Solicitation of Comments

    Interested persons are invited to submit written data, views, and
arguments concerning the foregoing, including whether the proposed rule
change is consistent with the Act. Comments may be submitted by any of
the following methods:

Electronic Comments

     Use the Commission's Internet comment form (http://www.sec.gov/rules/sro.shtml); or
     Send an email to<EMAIL_ADDRESS>Please include
File Number SR-Phlx-2014-011 on the subject line.

Paper Comments

     Send paper comments in triplicate to Elizabeth M. Murphy,
Secretary, Securities and Exchange Commission, 100 F Street NE.,
Washington, DC 20549-1090.

All submissions should refer to File Number SR-Phlx-2014-011. This file
number should be included on the subject line if email is used. To help
the Commission process and review your comments more efficiently,
please use only one method. The Commission will post all comments on
the Commission's Internet Web site (http://www.sec.gov/rules/sro.shtml).
    Copies of the submission, all subsequent amendments, all written
statements with respect to the proposed rule change that are filed with
the Commission, and all written communications relating to the proposed
rule change between the Commission and any person, other than those
that may be withheld from the public in accordance with the provisions
of 5 U.S.C. 552, will be available for Web site viewing and printing in
the Commission's Public Reference Room, 100 F Street NE., Washington,
DC 20549, on official business days between the hours of 10:00 a.m. and
3:00 p.m. Copies of the filing also will be available for inspection
and copying at the principal office of the Exchange. All comments
received will be posted without change; the Commission does not edit
personal identifying information from submissions. You should submit
only information that you wish to make available publicly.
    All submissions should refer to File Number SR-Phlx-2014-011 and
should be submitted on or before March 12, 2014.

    For the Commission, by the Division of Trading and Markets,
pursuant to delegated authority.\10\
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    \10\ 17 CFR 200.30-3(a)(12).
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Kevin M. O'Neill,
Deputy Secretary.
[FR Doc. 2014-03565 Filed 2-18-14; 8:45 am]
BILLING CODE 8011-01-P


[Federal Register Volume 79, Number 24 (Wednesday, February 5, 2014)]
[Rules and Regulations]
[Pages 6817-6819]
[FR Doc No: 2014-02441]

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DEPARTMENT OF HOMELAND SECURITY

Coast Guard

33 CFR Part 147

[Docket Number USCG-2013-0070]
RIN 1625-AA00

Safety Zone; Olympus Tension Leg Platform

AGENCY: Coast Guard, DHS.

ACTION: Final rule.

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SUMMARY: The Coast Guard is establishing a safety zone around the
Olympus Tension Leg Platform, Mississippi Canyon Block 807 on the OCS.
The purpose of the safety zone is to promote the safety of life and
property on the facilities, their appurtenances and attending vessels,
and on the adjacent waters within the safety zone. Placing a safety
zone around the facility will significantly reduce the threat of
allisions, oil spills, and releases of natural gas, and thereby protect
the safety of life, property, and the environment.

DATES: This rule is effective March 7, 2014.

ADDRESSES: Documents mentioned in this preamble are part of docket
[USCG-2013-0070]. To view documents mentioned in this preamble as being
available in the docket, go to http://www.regulations.gov, type the
docket number in the ``SEARCH'' box and click ``SEARCH.'' Click on Open
Docket Folder on the line associated with this rulemaking. You may also
visit the Docket Management Facility in Room W12-140 on the ground
floor of the Department of Transportation West Building, 1200 New
Jersey Avenue SE., Washington, DC 20590, between 9 a.m. and 5 p.m.,
Monday through Friday, except Federal holidays.

FOR FURTHER INFORMATION CONTACT: If you have questions on this rule,
call or email Mr. Rusty Wright, U.S. Coast Guard, District Eight
Waterways Management Branch; telephone<PHONE_NUMBER>,
<EMAIL_ADDRESS>If you have questions on viewing or submitting
material to the docket, call Cheryl Collins, Program Manager, Docket
Operations, telephone<PHONE_NUMBER>.

SUPPLEMENTARY INFORMATION:

Table of Acronyms

DHS Department of Homeland Security
USCG United States Coast Guard
FR Federal Register
NPRM Notice of Proposed Rulemaking
OCS Outer Continental Shelf

A. Regulatory History and Information

    On July 18, 2013, the Coast Guard published an NPRM entitled,
``Safety Zone; Olympus Tension Leg Platform on the Outer Continental
Shelf Platform in the Gulf of Mexico'' in the Federal Register [78 FR
42902] and requested comments on the proposed rule. The Coast Guard
received no comments, no public meetings were requested and none were
held.

B. Basis and Purpose

    Coast Guard regulations permit the establishment of safety zones
for facilities located on the OCS for the purpose of protecting life,
property and the marine environment (33 CFR 147.1). Placing a safety
zone around the facility will significantly reduce the threat of
allisions, oil spills, and releases of natural gas, and thereby protect
the safety of life, property, and the environment. The authority for
this rule is 14 U.S.C. 85, 43 U.S.C. 1333, and Department of Homeland
Security Delegation No. 0170.1.
    Shell Exploration and Production Company requested that the Coast
Guard establish a safety zone around the Olympus Tension Leg Platform
facility. The request for the safety zone was made due to safety
concerns for vessels operating in the area and the environment. Shell
Exploration and Production Company indicated that it is highly likely
that any allision with the facility would result in a catastrophic
event. In evaluating this request, the Coast Guard explored relevant
safety factors and considered several criteria, including but not
limited to, (1) the level of shipping activity around the facility, (2)
safety concerns for personnel aboard vessels operating in the area and
onboard the facility, (3) concerns for the environment, (4) the
possibility that an allision would result in a catastrophic event based
on proximity to shipping fairways, offloading operations, production
levels, and size of the crew, (5) the volume of traffic in the vicinity
of the safety zone area, (6) the types of vessels navigating in the
vicinity of the safety zone area, and (7) the structural configuration
of the facility.
    The safety zone established by this rulemaking is in the deepwater
area of the Gulf of Mexico, located at 28[deg]

9'35.59' N, 89[deg]14'20.86'' W in Mississippi Canyon Block 807. For
the purposes of this regulation, the deepwater area is considered to be
waters of 304.8 meters (1,000 feet) or greater depth extending to the
limits of the Exclusive Economic Zone (EEZ), which is contiguous to the
territorial sea of the United States, and extends up to 200 nautical
miles from the baseline from which the breadth of the territorial sea
is measured. Navigation in the area of the safety zone consists of
large commercial shipping vessels, fishing vessels, cruise ships, tugs
with tows and the occasional recreational vessel. The deepwater area
also includes an extensive system of fairways.

C. Discussion of Comments and Changes

    The Coast Guard received no comments in response to the NPRM and
there are no changes to the safety zone regulation as proposed by the
NPRM. One technical amendment is being made in this final rule to
correct the section number. The section number is changed from Sec.
147.848 to Sec.  147.849 to be consistent with the numbering of OCS
safety zones in the Coast Guard's Eighth District.

D. Regulatory Analyses

    We developed this rule after considering numerous statutes and
executive orders related to rulemaking. Below we summarize our analyses
based on these statutes and executive orders.

1. Regulatory Planning and Review

    This rule is not a significant regulatory action under section 3(f)
of Executive Order 12866, Regulatory Planning and Review, as
supplemented by Executive Order 13563, Improving Regulation and
Regulatory Review, and does not require an assessment of potential
costs and benefits under section 6(a)(3) of Executive Order 12866 or
under section 1 of Executive Order 13563. The Office of Management and
Budget has not reviewed it under those Orders. This rule is not a
significant regulatory action due to the location of the Olympus
Tension Leg Platform on the OCS and its distance from both land and
safety fairways. Vessels traversing waters near the safety zone will be
able to safely travel around the zone without incurring additional
costs.

2. Impact on Small Entities

    The Regulatory Flexibility Act of 1980 (RFA), 5 U.S.C. 601-612, as
amended, requires federal agencies to consider the potential impact of
regulations on small entities during rulemaking. The term ``small
entities'' comprises small businesses, not-for-profit organizations
that are independently owned and operated and are not dominant in their
fields, and governmental jurisdictions with populations of less than
50,000. The Coast Guard certifies under 5 U.S.C. 605(b) that this rule
will not have a significant economic impact on a substantial number of
small entities. This rule will affect the following entities, some of
which may be small entities: The owners or operators of vessels
intending to transit or anchor in Mississippi Canyon Block 807. This
safety zone will not have a significant economic impact on a
substantial number of small entities for the following reasons: (1)
This rule will enforce a safety zone around a production platform that
is in an area of the Gulf of Mexico not typically frequented by vessel
traffic; (2) this rule will enforce a safety zone that is not in close
proximity to a safety fairway; and (3) vessel traffic can pass safely
around the safety zone without incurring additional costs.

3. Collection of Information

    This rule will not call for a new collection of information under
the Paperwork Reduction Act of 1995 (44 U.S.C. 3501-3520).

4. Federalism

    A rule has implications for federalism under Executive Order 13132,
Federalism, if it has a substantial direct effect on the States, on the
relationship between the national government and the States, or on the
distribution of power and responsibilities among the various levels of
government. We have analyzed this rule under that Order and determined
that this rule does not have implications for federalism.

5. Unfunded Mandates Reform Act

    The Unfunded Mandates Reform Act of 1995 (2 U.S.C. 1531-1538)
requires Federal agencies to assess the effects of their discretionary
regulatory actions. In particular, the Act addresses actions that may
result in the expenditure by a State, local, or tribal government, in
the aggregate, or by the private sector of $100,000,000 (adjusted for
inflation) or more in any one year. Though this rule will not result in
such an expenditure, we do discuss the effects of this rule elsewhere
in this preamble.

6. Taking of Private Property

    This rule will not cause a taking of private property or otherwise
have taking implications under Executive Order 12630, Governmental
Actions and Interference with Constitutionally Protected Property
Rights.

7. Civil Justice Reform

    This rule meets applicable standards in sections 3(a) and 3(b)(2)
of Executive Order 12988, Civil Justice Reform, to minimize litigation,
eliminate ambiguity, and reduce burden.

8. Protection of Children

    We have analyzed this rule under Executive Order 13045, Protection
of Children from Environmental Health Risks and Safety Risks. This rule
is not an economically significant rule and does not create an
environmental risk to health or risk to safety that may
disproportionately affect children.

9. Indian Tribal Governments

    This rule does not have tribal implications under Executive Order
13175, Consultation and Coordination with Indian Tribal Governments,
because it does not have a substantial direct effect on one or more
Indian tribes, on the relationship between the Federal Government and
Indian tribes, or on the distribution of power and responsibilities
between the Federal Government and Indian tribes.

10. Energy Effects

    This action is not a ``significant energy action'' under Executive
Order 13211, Actions Concerning Regulations That Significantly Affect
Energy Supply, Distribution, or Use.

11. Technical Standards

    This rule does not use technical standards. Therefore, we did not
consider the use of voluntary consensus standards.

12. Environment

    We have analyzed this rule under Department of Homeland Security
Management Directive 023-01 and Commandant Instruction M16475.lD, which
guide the Coast Guard in complying with the National Environmental
Policy Act of 1969 (NEPA)(42 U.S.C. 4321-4370f), and have determined
that this action is one of a category of actions that do not
individually or cumulatively have a significant effect on the human
environment. Safety zones are established around OCS facilities being
constructed, maintained, or operated on the OCS to promote the safety
of life and property on the facilities, their appurtenances and
attending vessels, and on the adjacent waters within the safety zones.
A safety zone may extend to a maximum distance of 500 meters around the
OCS facility measured from

each point on its outer edge or from its construction site, but may not
interfere with the use of recognized sea lanes essential to navigation.
This rule is categorically excluded from further review under paragraph
34(g) of Figure 2-1 of the Commandant Instruction. An environmental
analysis checklist supporting this determination and a Categorical
Exclusion Determination are available in the docket where indicated
under ADDRESSES.

List of Subjects in 33 CFR Part 147

    Continental shelf, Marine safety, Navigation (water).

    For the reasons discussed in the preamble, the Coast Guard amends
33 CFR part 147 as follows:

PART 147--SAFETY ZONES

0
1. The authority citation for part 147 continues to read as follows:

    Authority:  14 U.S.C. 85; 43 U.S.C. 1333; Department of Homeland
Security Delegation No. 0170.1.

0
2. Add Sec.  147.849 to read as follows:

Sec.  147.849  Safety Zone; Olympus Tension Leg Platform.

    (a) Description. The Olympus Tension Leg Platform is in the
deepwater area of the Gulf of Mexico in Mississippi Canyon Block 807B.
The facility is located at 28[deg] 9'35.59'' N, 89[deg]14'20.86'' W.
The area within 500 meters (1640.4 feet) from each point on the
structure's outer edge and the area within 500 meters (1640.4 feet) of
each of the supply boat mooring buoys is a safety zone.
    (b) Regulation. No vessel may enter or remain in this safety zone
except the following:
    (1) An attending vessel;
    (2) A vessel under 100 feet in length overall not engaged in
towing; or
    (3) A vessel authorized by the Commander, Eighth Coast Guard
District or a designated representative.

    Dated: January 10, 2014.
Kevin S. Cook,
Rear Admiral, U.S. Coast Guard, Commander, Eighth Coast Guard District.
[FR Doc. 2014-02441 Filed 2-4-14; 8:45 am]
BILLING CODE 9110-04-P


[Federal Register Volume 79, Number 83 (Wednesday, April 30, 2014)]
[Rules and Regulations]
[Pages 24340-24347]
[FR Doc No: 2014-09726]

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ENVIRONMENTAL PROTECTION AGENCY

40 CFR Part 52

[EPA-R03-OAR-2012-0002; FRL-9910-06-Region 3]

Approval and Promulgation of Air Quality Implementation Plans;
Pennsylvania; Regional Haze State Implementation Plan

AGENCY: Environmental Protection Agency (EPA).

ACTION: Final rule.

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SUMMARY: The Environmental Protection Agency (EPA) is reissuing its
final limited approval of the Pennsylvania State Implementation Plan
(SIP) to implement the regional haze program for the first planning
period through 2018. EPA originally finalized a limited approval of the
Pennsylvania regional haze SIP on July 13, 2012. In response to a
petition for review of that final action in the United States Court of
Appeals for the Third Circuit, EPA successfully moved for a voluntary
remand, without vacatur, to more adequately respond to certain public
comments. EPA is providing new responses to those comments in this
rulemaking notice.

DATES: This final rule is effective on May 30, 2014.

ADDRESSES: EPA has established a docket for this action under Docket ID
Number EPA-R03-OAR-2012-0002. All documents in the docket are listed in
the www.regulations.gov Web site. Although listed in the electronic
docket, some information is not publicly available, i.e., confidential
business information (CBI) or other information whose disclosure is
restricted by statute. Certain other material, such as copyrighted
material, is not placed on the Internet and will be publicly available
only in hard copy form. Publicly available docket materials are
available either electronically through www.regulations.gov or in hard
copy for public inspection during normal business hours at the Air
Protection Division, U.S. Environmental Protection Agency, Region III,
1650 Arch Street, Philadelphia, Pennsylvania 19103. Copies of the
Commonwealth's submittal are available at the Pennsylvania Department
of Environmental Protection, Bureau of Air Quality Control, P.O. Box
8468, 400 Market Street, Harrisburg, Pennsylvania 17105.

FOR FURTHER INFORMATION CONTACT: Asrah Khadr, U.S. EPA, Region 3, (215)
814-2071, or by email at<EMAIL_ADDRESS>
SUPPLEMENTARY INFORMATION: Throughout this document, ``we,'' ``us,''
and ``our'' refer to EPA.

Table of Contents

I. Background
II. Public Comments and EPA Responses
III. Summary of Final Action
IV. Statutory and Executive Order Reviews

I. Background

    On January 26, 2012, EPA proposed a limited approval of the
Pennsylvania regional haze SIP as meeting most of the applicable
requirements of sections 169A and 169B of the Clean Air Act (CAA) and
EPA's implementing regulations at 40 CFR 51.308-309 (Regional Haze
Rule) and 40 CFR 51, appendix Y (BART Guidelines). 77 FR 3984. In that
same action, EPA proposed to approve the Pennsylvania regional haze SIP
as meeting the infrastructure requirements of section 110(a)(2) of the
CAA relating to visibility protection for the 1997 8-hour ozone
National Ambient Air Quality Standard (NAAQS) and the 1997 and 2006
fine particulate matter (PM2.5) NAAQS. EPA received several
adverse comments on its proposed limited approval, including comments
from Earthjustice on behalf of Sierra Club, the National Parks
Conservation Association, and the Clean Air Council.
    In a separate but related action, EPA had previously proposed a
limited disapproval of the Pennsylvania regional haze SIP for relying
on the Clean Air Interstate Rule (CAIR) \1\ to satisfy the best
available retrofit technology (BART) requirement for emissions of
sulfur dioxide (SO2) and nitrogen oxides (NOX)
from Pennsylvania's BART-eligible electric generating units (EGUs). 76
FR 82219. In that same action, EPA proposed a Federal Implementation
Plan (FIP) that replaced Pennsylvania's reliance on CAIR with reliance
on the Cross-State Air Pollution Rule (CSAPR).\2\
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    \1\ CAIR required certain states, including Pennsylvania, to
reduce emissions of SO2 and NOX that
significantly contribute to downwind nonattainment of the 1997 NAAQS
for ozone and PM2.5. 70 FR 25162 (May 12, 2005).
    \2\ EPA promulgated CSAPR (76 FR 48208, August 8, 2011) as a
replacement to CAIR in response to the United States Court of
Appeals for the District of Columbia Circuit's decision in North
Carolina v. EPA, 531 F.3d 896 (D.C. Cir. 2008).

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    On June 7, 2012, EPA finalized the limited disapproval of the
Pennsylvania regional haze SIP for relying on CAIR and the FIP relying
on CSAPR. 77 FR 33642. On July 13, 2012, EPA finalized the limited
approval of the Pennsylvania regional haze SIP and approved the
Pennsylvania regional haze SIP as meeting the infrastructure
requirements of section 110(a)(2) relating to visibility protection for
the 1997 8-hour ozone NAAQS and the 1997 and 2006 PM2.5
NAAQS. 77 FR 41279.
    Following these actions, the DC Circuit issued a decision in EME
Homer City Generation, L.P. v. EPA, 696 F.3d 7 (D.C. Cir. 2012), cert.
granted 133 U.S. 2,857 (2013), vacating CSAPR and keeping CAIR in place
pending EPA's promulgation of a valid replacement rule for CSAPR. EPA
believes that the United States Supreme Court's decision in EME Homer
City will impact the reasoning that formed the basis for EPA's limited
disapproval of the Pennsylvania regional haze SIP and expects to
propose an appropriate action regarding the limited disapproval upon
final resolution of that case.
    On September 11, 2012, the aforementioned public interest groups
filed a petition for review of EPA's final limited approval of the
Pennsylvania regional haze SIP in the Third Circuit. See Nat'l Parks
Conservation Ass'n, et al. v. EPA, No. 12-3534 (3d Cir. Sept. 11,
2012). In response to the petition, EPA moved the court for a voluntary
remand of the final limited approval, without vacatur, so that EPA
could provide a more detailed and complete response to some of the
petitioners' adverse comments. See Motion for Voluntary Remand at 3,
Nat'l Parks Conservation Ass'n, et al. v. EPA, No. 12-3534 (3d Cir.
Sept. 27, 2013). On October 22, 2013, the court granted EPA's motion
for a voluntary remand without vacatur.

II. Public Comments and EPA Responses

    EPA received several comments on our January 6, 2012 proposed
limited approval of the Pennsylvania regional haze SIP. Commenters
included the U.S. Forest Service, the National Park Service, the State
of New Jersey Department of Environmental Protection, GenOn Energy,
Inc., a private citizen, and Earthjustice (on behalf of Sierra Club,
the National Parks Conservation Association, and the Clean Air
Council). As EPA explained in the motion for voluntary remand, EPA does
not intend to readdress Earthjustice's comments relating to CAIR/CSAPR
issues.\3\ Consistent with this representation, EPA does not readdress
these comments in this rulemaking notice. In addition to comments from
Earthjustice, we are also responding to significant comments from the
National Park Service and the State of New Jersey Department of
Environmental Protection in this rulemaking notice. EPA believes that
the previous responses to all other significant comments were adequate.
Please refer to the July 13, 2012 Federal Register rulemaking notice
for these comment summaries and responses. 77 FR 41279.
---------------------------------------------------------------------------

    \3\ See Motion at 11 n.6.
---------------------------------------------------------------------------

BART Determinations for EGUs and Non-EGUs

    Comment: One commenter raised a number of concerns with
Pennsylvania's BART determinations for both EGUs and non-EGUs. Some of
these concerns focused on the overall level of detail, structure,
analysis, and supporting documentation that Pennsylvania provided in
its BART analyses, while other concerns targeted specific technical
deficiencies in Pennsylvania's cost-effectiveness estimates and
visibility modeling. For EGUs, the commenter criticized Pennsylvania
for rejecting fabric filter baghouses, which are generally considered
to be the most stringent control technology available for particulate
matter (PM) emissions. The commenter went into considerable detail
pointing out various shortcomings and errors in Pennsylvania's PM BART
analyses that allegedly resulted in grossly inflated costs and
underestimated visibility benefits for baghouses. In regards to
Pennsylvania's cost calculations, the commenter alleged that: (1)
Baseline emission estimates were unrealistic and unsupported; (2)
supporting data for the cost calculations was not available for public
review and comment; (3) lack of data made it impossible to know whether
the overnight cost method was followed as required by the Cost Control
Manual and BART Guidelines; (4) remaining useful lives of the sources
were unsupported; and (5) control efficiencies for the control options
analyzed were arbitrarily low and unsupported. To account for these
deficiencies, the commenter hired a contractor to recalculate the cost-
effectiveness of fabric filter baghouses for two of the EGUs--Homer
City Unit 2 and Hatfield's Ferry Unit 2. The commenter found that the
installation of baghouses at these units would be cost-effective at
$2,245 per ton and $2,745 per ton, respectively.
    This commenter also alleged that Pennsylvania's source-specific
BART determinations contained ``systemic deficiencies.'' These
deficiencies include: (1) Missing source-specific design information,
such as megawatt rating of boilers and exhaust gas flow rates and
composition, which prevented accurate costing; (2) improper use of the
dollars per deciview ($/dv) metric as a cutpoint in making BART
determinations, contrary to EPA guidance and EPA's statements in other
regional haze actions; (3) lack of clear cost and visibility thresholds
for determining when controls will be required or rejected; (4) failure
to consider cumulative visibility impacts at all five Class I areas
impacted by Pennsylvania sources; and (5) failure to follow the five-
step BART process as outlined in the BART Guidelines, including the
omission of available control options in Step 1, a lack of feasibility
demonstrations in Step 2, a lack of control-effectiveness ranking in
Step 3, and a summary dismissal of energy and non-air quality
environmental impacts in Step 4.
    Another commenter took issue with Pennsylvania's cost analyses for
several non-EGUs, including cement kilns and a pulp and paper mill.
This commenter explained that selective non-catalytic reduction (SNCR)
has become the norm for controlling NOX emissions from
cement kilns year-round, and that EPA should require a minimum of 35
percent NOX reduction on a 30-day rolling basis at all
kilns. This commenter also disagreed with Pennsylvania's cost analysis
for the P.H. Glatfelter Company (Glatfelter) pulp and paper mill. The
commenter argued that Pennsylvania overestimated the costs of wet
scrubbers by deviating from the Control Cost Manual in several ways. As
a result of these deviations, the commenter found that the cost-
effectiveness of wet scrubbers was only $1,204 per ton instead of the
$1,667 per ton estimated by Pennsylvania. In light of this lower cost
and the visibility benefits of controls, the commenter concluded that
EPA should disapprove Pennsylvania's BART determination for Glatfelter
and require a 90 percent efficient wet scrubber.
    Finally, multiple commenters raised concerns with Pennsylvania's
consideration of the visibility factor for multiple BART-eligible
sources. These commenters argued that Pennsylvania failed to consider
the cumulative visibility impact at multiple Class I areas when
evaluating potential control alternatives and disputed Pennsylvania's
decision that such an analysis was unwarranted. The

commenters also criticized Pennsylvania's reliance on the $/dv metric,
alleging that the use of such a metric would not be meaningful if it
did not take into account the visibility improvement at multiple Class
I areas. In addition, the commenters argued that Pennsylvania should
have established an objective criteria for determining the
acceptability of a given control technology's visibility improvement.
    Response: In its regional haze SIP, Pennsylvania identified 34
BART-eligible sources. Consistent with the Mid-Atlantic Northeast
Visibility Union (MANE-VU) protocol, Pennsylvania did not limit its
BART analyses to those sources that it first determined ``might
reasonably be anticipated to cause or contribute to'' visibility
impairment in a Class I area based on air quality modeling. See section
169(b)(2)(A). Rather, Pennsylvania considered the appropriateness of
BART controls at each BART-eligible source in Pennsylvania.\4\ EPA
notes that in most other states, BART reviews were undertaken only for
those BART-eligible sources shown to have a greater than 0.5 deciview
(dv) impact on a Class I area, the maximum threshold for this screening
analysis. Of Pennsylvania's 34 BART-eligible sources, the regional haze
SIP indicates that 26 had visibility impacts of less than 0.5 dv on any
Class I area. EPA notes that in most states, the consideration of
controls would have ended at this point in the analysis. Pennsylvania,
however, considered whether additional controls would be appropriate
for all 26 of these BART-eligible sources, regardless of whether or not
the source by itself ``cause[s] or contribute[s]'' to visibility
impairment.
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    \4\ As Pennsylvania relied on CAIR to meet the BART requirements
for SO2 and NOX, Pennsylvania was only
required to determine whether its BART-eligible EGUs should be
required to install BART controls for direct emissions of PM.
---------------------------------------------------------------------------

    Based on EPA's assessment of the information in Pennsylvania's BART
analyses, EPA has concluded that many of the comments criticizing
Pennsylvania's BART determinations are correct. Because of its approach
to BART, Pennsylvania considered the appropriateness of BART controls
at a large number of sources. But for almost all of these sources, the
Pennsylvania regional haze SIP contains very limited information
describing Pennsylvania's analyses and consideration of the BART
factors. Pennsylvania considered various control strategies and
developed estimates of the costs of controls, but the cursory
information available in the record does not allow for an assessment of
how these numbers were derived or whether Pennsylvania's analyses were
reasonably done. Similarly, it is difficult to assess the estimates of
the improvements in visibility associated with various controls given
the limited information in the SIP as to the assumptions relied on in
the modeling and the summary nature of the results provided. EPA also
agrees with the commenters that, in considering the visibility
improvement expected from the use of controls, Pennsylvania should have
taken into account the visibility impacts at all impacted Class I areas
rather than focusing solely on the benefits at the most impacted area.
Similarly, EPA agrees with the commenters that Pennsylvania's reliance
on the $/dv metric was flawed for multiple reasons.
    Although Pennsylvania should have provided a more thorough and
detailed analysis of costs and visibility impacts in its regional haze
SIP, the information that Pennsylvania did provide has led EPA to
conclude that Pennsylvania's ultimate BART determinations were
nevertheless reasonable. First, based on the cost estimates for other
BART sources in other states, EPA has concluded that Pennsylvania's
cost numbers appear to be generally consistent for such controls, at
least for purposes of screening type analyses. Where Pennsylvania
estimated the costs of controls to be in the tens of thousands or
hundreds of thousands of dollars per ton of pollutant removed,
Pennsylvania's conclusions that such controls are not cost-effective
seem reasonable, even assuming that the true cost of controls are
likely less than what Pennsylvania estimated. EPA agrees with the
commenters, however, that many of the controls under consideration were
likely cost-effective measures. Unfortunately, where controls were
estimated to be more cost-effective, EPA cannot assess the extent to
which Pennsylvania's analyses are reasonable estimates for purposes of
making a BART determination. When the other key BART factor--
visibility--is taken into account, however, an overall picture emerges
that supports Pennsylvania's BART determinations.
    As noted earlier, Pennsylvania reviewed each of its BART-eligible
sources regardless of whether they cause or contribute to visibility
impairment under the test in the BART Guidelines. Given the magnitude
of the source-specific impacts of these 26 BART-eligible sources, it is
not surprising that Pennsylvania concluded that additional controls
were not warranted. The visibility benefits of controls for this large
subset of Pennsylvania's BART-eligible sources were generally estimated
to be only in the hundredths of a deciview. For example, Pennsylvania
estimated that SO2 controls at the two kilns at Lafarge
Corporation's Whitehall Plant would result in 0.044 and 0.035 dv of
improvement at Brigantine National Wildlife Refuge in New Jersey, the
most impacted Class I area. No State has required BART controls where
the benefits of control were in this range, and EPA does not consider
Pennsylvania's control determinations to be unreasonable given these
visibility numbers. Taking into account the visibility impacts at
multiple Class I areas would not have affected the reasonableness of
Pennsylvania's conclusion that the benefit of controls would have
little or no impact on improving visibility given the magnitude of the
visibility results shown at the most impacted area.
    Of the 26 facilities with visibility impacts less than 0.5 dv at
any Class I area, the only source where the BART factors suggest that
Pennsylvania reasonably could have come to a different conclusion is
the Glatfelter pulp and paper production facility. Unlike the other 26
sources, where either the costs of control were unreasonable or the
visibility benefits minimal, or both, Pennsylvania estimated the costs
of SO2 controls at Glatfelter to fall within a range that is
generally considered highly cost-effective. Further, these controls
would result in 0.219 dv of improvement at Shenandoah National Park,
the most impacted Class I area. In its comments, the National Park
Service argued that Pennsylvania had overestimated the costs of
SO2 controls, but regardless of whether the costs were
$1,667 per ton, as estimated by Pennsylvania, or $1,204 per ton, as
estimated by the National Park Service, the costs of installing a
venturi scrubber (the SO2 controls under consideration)
falls within a range that is generally considered very reasonable. The
National Park Service also provided additional information regarding
the visibility improvements to be expected at Brigantine National
Wildlife Refuge (0.218 dv) and noted that Dolly Sods and Otter Creek
Wilderness Areas had visibility impacts ``about half'' those at
Shenandoah and Brigantine. EPA notes, however, that if Pennsylvania had
chosen to screen out sources with impacts of less than 0.5 dv, it would
not have been required to undertake a BART analysis for this source at
all. For this reason, EPA is not disapproving Pennsylvania's conclusion
that BART controls should not be required at this source.
    Of the remaining eight BART-eligible sources, there is no
information in the

Pennsylvania regional haze SIP regarding the sources' baseline
visibility impacts for four of the sources--Allegheny Energy Supply's
Mitchell Power Station, PPL Generation LLC's Brunner Island, Sunoco
Chemicals' Frankford Plant, and Sunoco, Inc.'s petroleum refining
facility. Pennsylvania did consider the visibility benefits associated
with the installation of controls at these facilities, however, and
determined that on balance, the costs of controls were not justified by
the expected minimal visibility impacts. At these four facilities, the
greatest improvement in visibility was estimated to be 0.076 dv from
the installation of selective catalytic reduction (SCR) at the
Frankford Plant (at $40,495 per ton). As the visibility benefits of
controls were in the hundredths or thousandths of a deciview, EPA does
not consider Pennsylvania's BART determinations to be unreasonable for
these four sources, for the same reasons as explained earlier.
    The remaining four BART-eligible sources were each estimated to
have visibility impacts above 0.5 dv at a Class I area. These
facilities are Lehigh Cement's Evansville Cement Plant (Lehigh/
Evansville), PPL Generation LLC's Martins Creek Generating Station
(Martins Creek), ConocoPhillips' Trainer Refinery, and Sunoco's Marcus
Hook Refinery. Sunoco's Marcus Hook Refinery has shut down, however,
and has surrendered its Title V operating permit. Therefore, the
question of appropriate BART controls for this source is now moot.
    Pennsylvania's regional haze SIP indicates that both Lehigh/
Evansville and Martins Creek are each estimated to have impacts of just
over 0.6 dv at a Class I area. For Lehigh/Evansville, Pennsylvania
found that NOX emissions from Kilns 1 and 2 are responsible
for the preponderance of the visibility impacts, and considered both
the costs and visibility benefits of a range of NOX and
SO2 controls. While certain of the controls under
consideration were cost-effective, the visibility benefits were between
0.005 and 0.040 dv. Although Pennsylvania considered only the most
impacted Class I area, taking into account the visibility impacts at
multiple Class I areas would not have changed Pennsylvania's conclusion
that no additional controls were justified given the magnitude of
impacts at the most impacted area. For Martins Creek, an EGU,
Pennsylvania considered only PM controls in light of the fact that it
is relying on CAIR as an alternative to BART for SO2 and
NOX. Its cost analysis indicated that emission controls for
PM were over $100,000 per ton, while visibility benefits ranged from
0.037 dv at Brigantine to 0.022 dv at Lye Brook. Consequently, EPA
believes that Pennsylvania's conclusion that BART was no additional
control was reasonable for this source as well.
    The last of the remaining BART-eligible sources is ConocoPhillips'
Trainer Refinery, which was found to have a 1.104 dv impact at
Brigantine. This impact was due largely to emissions from two units, a
CO boiler (CO1) and a platformer feed heater (Unit 738). Pennsylvania
noted that CO1 is subject to a Federal consent decree that requires the
installation of a wet scrubber and enhanced SNCR to address
SO2 and NOX emissions, respectively. Pennsylvania
also noted that the unit's PM emissions are subject to a new source
performance standard (NSPS) PM limit of 0.5 pounds per 1000 pounds of
coke burned. Pennsylvania concluded that no additional retrofit
controls were feasible for this unit. EPA disagrees with this
conclusion. Notably, EPA believes that SCR is likely a feasible control
option for NOX emissions and should have been analyzed.
Nevertheless, it is highly unlikely that Pennsylvania would have found
SCR to be cost-effective given that SNCR has already been installed on
CO1. Therefore, while Pennsylvania should have performed an analysis of
SCR, EPA cannot conclude that Pennsylvania's determination that no
further controls are warranted, was unreasonable. For Unit 738,
Pennsylvania considered several possible SO2,
NOX, and PM control options. Although Pennsylvania did not
provide an adequate explanation as to why certain of the SO2
and PM controls were not feasible or provide supporting information for
its cost analyses, EPA notes that the visibility impacts from Unit 738
for these two pollutants were estimated to be 0.000 dv and 0.001 dv
respectively at the most impacted Class I area. Given this, EPA cannot
conclude that Pennsylvania was unreasonable in finding that no further
SO2 or PM controls were needed for this unit. The visibility
impacts from Unit 738 for NOX were estimated to be 0.159 dv.
Pennsylvania determined that the most effective control, SCR in
combination with ultra low-NOX burners, would cost over
$70,000 per ton of NOX removed. The less costly but less
effective use of ultra low NOX burners alone was estimated
to cost of $16,042 per ton, with a visibility benefit of 0.025 dv. Even
assuming that the cost of the burners was significantly less, EPA again
does not disagree with Pennsylvania's conclusion that these controls
are unwarranted for BART.
    EPA has closely reviewed Pennsylvania's BART determinations and
concluded that Pennsylvania's ultimate conclusions were not
unreasonable, largely based on the expected minimal impacts on
visibility, but also taking into account the very high costs of some
controls. In other cases, changes in operating status or the existence
of enforceable provisions requiring the installation of stringent new
controls have convinced EPA that disapproving Pennsylvania's regional
haze SIP would result in no meaningful changes to Pennsylvania's
ultimate control determinations. As a result, notwithstanding the large
number of errors in Pennsylvania's BART determinations, EPA is re-
finalizing the limited approval of the Commonwealth's regional haze
SIP.

PM BART Emission Limits for EGUs

    Comment: One commenter asserted that Pennsylvania improperly set
the PM BART emission limits at every EGU source at 0.1 pound per
million British thermal units (lb/MMBtu). The commenter explained that
0.1 lb/MMBtu, the emission limit currently included in all of the EGUs'
operating permits, is based on 40-year old technology that does not
satisfy the minimum statutory requirements of BART. The commenter
argued that 0.1 lb/MMBtu is substantially higher than limits accepted
as BART elsewhere, as well as limits established as best available
control technology (BACT). The commenter asserted that BACT limits are
relevant for BART purposes because BACT is also derived by a five-step
process and must demonstrate achievable emission reductions. The
commenter criticized Pennsylvania for not considering BACT technologies
and associated emission limits in its BART analyses. The commenter then
provided a substantial list of PM emission limits that have been
established as either BACT or BART by other states and permitting
authorities. The commenter explained that these lower limits could be
met by both electrostatic precipitators (ESPs) and fabric filter
baghouses and concluded that Pennsylvania's failure to adopt such lower
limits as PM BART for its EGUs was arbitrary and unlawful. Finally, the
commenter pointed out that the BART Guidelines provide that maximum
achievable control technology (MACT) for control of hazardous air
pollutants should be taken into account in determining BART. The
commenter asserted that EPA could not lawfully or rationally approve
Pennsylvania's PM BART limits because they are less stringent than the
0.03 lb/MMBtu

emission limit that EPA recently established as MACT for existing
sources in the final Mercury and Air Toxics Standards (MATS) Rule.
    Response: EPA disagrees with the commenter that Pennsylvania's PM
BART emission limits for EGUs must be disapproved. EPA acknowledges
that BART is defined as ``as an emission limitation based on the degree
of reduction achievable through the application of the best system of
continuous emission reduction for each pollutant which is emitted by an
existing stationary facility.'' 40 CFR 51.301. Consequently, once a
state has selected a control technology that represents BART, the state
must then complete the BART analysis by selecting an emission limit
that represents the emission-reduction capabilities of that control
technology. While other BART limits should be examined when determining
the effectiveness of the chosen control option, BART ultimately remains
a site-specific, case-by-case determination. Moreover, while BACT
limits may prove useful in identifying the appropriate emission limit
for BART, EPA disagree that BACT levels of control can automatically be
presumed ``achievable'' for BART purposes. Whereas BACT applies to new
and modified sources, BART only applies to retrofits for older sources.
Thus, there may be instances where a source installing BART cannot
achieve the level of reductions that would be possible at an entirely
new source.
    Here, Pennsylvania determined that PM BART for most of the subject-
to-BART EGUs \5\ was their existing permitted emission limits of 0.1
lb/MMBtu, which can be achieved by the existing ESPs. While EPA agrees
with the commenter that Pennsylvania ideally should have examined
whether 0.1 lb/MMBtu actually reflects the ``degree of reduction
achievable'' for the particular ESP at each facility, EPA thinks that
Pennsylvania's failure to do so was not fatal in this instance for
several reasons. First and most importantly, the impact of tightening
the EGUs' PM emission limits would be minimal from a visibility
perspective. As explained in detail earlier, the modeling included in
the Pennsylvania regional haze SIP clearly showed that the EGUs' PM
emissions were responsible for a minimal portion of the visibility
impairment at the affected Class I areas.
---------------------------------------------------------------------------

    \5\ Instead of setting an output-based PM emission limit for
GenOn Energy's Cheswick generating station, Pennsylvania capped PM
emissions at 361 tons per year (tpy). However, as EPA has previously
stated, Pennsylvania appears to have set the PM BART limit for
Cheswick in error. 77 FR 41279, 41283 (July 13, 2012). Pennsylvania
has submitted a SIP revision to EPA that includes a revised PM BART
emission limit for Cheswick to address this concern which EPA
intends to act upon expeditiously. See Letter to Shawn M. Garvin,
Regional Administrator, EPA, from E. Christopher Abruzzo, Secretary,
Pennsylvania Department of Environmental Protection (March 25,
2014), available at http://www.dep.state.pa.us/dep/deputate/airwaste/aq/plans/plans/cheswick/Transmittal_Letter_to_EPA.pdf.
---------------------------------------------------------------------------

    Second, many of the Pennsylvania EGUs have retired or put in motion
plans to retire or to convert to cleaner burning fuels since
Pennsylvania conducted its BART determinations. For example, in October
2013, First Energy's Hatfield's Ferry and Mitchell generating stations
were retired. NRG Energy's Portland generating station will cease
combusting coal in June 2014 and plans to retire in early 2015. NRG
Energy's New Castle generating station has submitted an application to
Pennsylvania to convert to natural gas as a fuel source prior to the
MATS compliance deadline of 2015. Moreover, many of the EGUs have
recently installed new pollution controls to comply with other CAA
requirements that further limit PM emissions. Pennsylvania has issued a
plan approval for construction of a baghouse and dry scrubber for Units
1 and 2 at Homer City, which also includes a new PM emission limit of
0.05 lb/MMBtu for each unit. These recent developments have made the
stringency of Pennsylvania's PM BART limits a moot issue for many
facilities.
    Finally, as the commenter notes, the aforementioned MATS Rule will
limit PM emissions at each of the Pennsylvania EGUs to 0.03 lb/MMBtu by
2015. While EPA disagrees with the commenter that EPA must disapprove
Pennsylvania's PM BART emission limits for EGUs due to the pending
implementation of MATS, the fact remains that MATS will imminently
supersede BART as the required level of PM control at Pennsylvania's
EGUs, largely mooting the issue. Disapproving Pennsylvania's PM BART
limits due to MATS would be inappropriate, however, because EPA cannot
require states to predict future requirements at the time they are
developing their SIPs. EPA proposed MATS on May 13, 2011 (76 FR 24976)
and promulgated the final version of MATS on February 16, 2012 (77 FR
9304), well after Pennsylvania developed its regional haze SIP and made
the relevant BART determinations. Furthermore, EPA proposed its limited
approval of Pennsylvania's regional haze SIP on January 26, 2012, a
full three weeks before MATS was finalized. EPA also revised MATS on
April 24, 2013 (78 FR 24073). While the BART Guidelines indicate that
states may rely on previously issued MACT standards for purposes of
BART, they do not require states to revise BART determinations ex post
facto when EPA subsequently establishes new MACT standards. For all of
these reasons, EPA believes that the limits of 0.1 lb/MMBtu are
sufficiently reasonable for PM BART at the Pennsylvania EGUs and can be
approved. Where appropriate, however, EPA expects Pennsylvania to
revisit the issue in the next regional haze implementation period.
    Comment: One commenter argued that Pennsylvania's PM BART emission
limits are invalid because they are expressed as total filterable PM.
The commenter argued that EPA must disapprove the limits and set
separate emission limits for filterable coarse particulate matter
(PM10) and PM2.5, as well as condensable PM.
Alternatively, EPA could set emission limits for the individual
pollutants that form condensable PM, such as sulfuric acid mist.
    Response: EPA disagrees that Pennsylvania was required to set
separate emission limits for filterable PM10 and
PM2.5 and condensable PM. While the BART Guidelines do
instruct states to consider both PM10 and PM2.5
when determining whether sources cause or contribute to visibility
impairment, the BART Guidelines are silent as to how PM emission limits
should be expressed, so long as they are enforceable, continuous, and
contain appropriate averaging times, compliance verification
procedures, and recordkeeping requirements. In practical terms, the
function of a BART emission limit is to ensure that the technology
selected as BART, or another technology that is at least as effective,
is installed and properly operated. For the EGUs in Pennsylvania, the
Commonwealth selected the existing ESPs as BART for filterable PM
emissions. An emission limit that restricts total filterable PM will,
by definition, restrict emissions of both filterable PM10
and PM2.5 because these are subsets of total filterable PM.
Thus, EPA believes that it is unnecessary for states to set separate
emission limits for filterable PM10 and PM2.5 in
order to ensure that the existing ESPs are properly operated and that
both coarse and fine particulates are adequately controlled. In regards
to condensable PM, when emitted from coal-fired EGUs, these emissions
are composed almost entirely of inorganic sulfates that are controlled
by scrubbers or dry sorbent injection, not by ESPs or fabric filter
baghouses. Consequently, EPA believes that Pennsylvania's

reliance on CAIR/CSAPR for SO2 BART is sufficient to ensure
that condensable PM emissions will be controlled.

Long-Term Strategy

    Comment: Several commenters stated that Pennsylvania, in
consultation with other states within MANE-VU, committed to include a
low-sulfur fuel strategy as part of its long-term strategy to reduce
emissions. These commenters noted that, as of February 2012,
Pennsylvania had proposed, but not yet adopted, a low-sulfur fuel rule.
Because Pennsylvania's low-sulfur fuel rule had not been finalized at
the time of EPA's proposed limited approval of Pennsylvania's regional
haze SIP, the commenters concluded that Pennsylvania had not taken all
of the measures necessary to obtain its share of the emission
reductions needed to meet the reasonable progress goals (RPGs) for
downwind Class I areas. One of these commenters recommended that EPA
condition its approval of the Pennsylvania regional haze SIP on the
implementation of the low-sulfur fuel strategy in Pennsylvania. Another
commenter criticized EPA for proposing to substitute SO2
reductions from EGUs and non-EGUs for reductions from a low-sulfur fuel
rule, noting that the substitution resulted in a 5,702 ton shortfall.
This commenter explained that because New Jersey relied on reductions
from Pennsylvania's low sulfur fuel strategy in demonstrating
reasonable progress at Brigantine Wilderness Area, an EPA approval
would jeopardize New Jersey's ability to meet its regional haze
commitments. A third commenter expressed concern that the emission
reductions Pennsylvania needs to meet the RPGs for downwind Class I
areas are not enforceable in the SIP. This commenter argued that
finalizing an approval of Pennsylvania's long-term strategy would be
inconsistent with other EPA actions that have acknowledged that all
reductions modeled in setting the RPGs must be enforceable.
    Response: EPA disagrees that Pennsylvania has failed to obtain its
share of emission reductions that it committed to in the state
consultation process. Pennsylvania participated fully in the MANE-VU
consultation process, which resulted in a course of action for all
participating states to reduce emissions to collectively meet the RPGs
in the MANE-VU region.\6\ The MANE-VU ``Ask'' provided the MANE-VU
states, including Pennsylvania, with up to ten years ``to pursue
adoption and implementation of reasonable and cost-effective
NOX and SO2 emissions reduction measures, as
appropriate and necessary.'' In its regional haze SIP, Pennsylvania
stated that it ``will pursue these measures, as appropriate and
necessary, and in five years at the time of Pennsylvania's first
periodic SIP report, expects to report on progress toward adoption of
these measures by 2018.'' With respect to the low-sulfur fuel strategy,
the MANE-VU Ask established two sets of goals, one for the ``inner
zone'' states of the MANE-VU region (Delaware, New Jersey, New York,
and Pennsylvania, or portions thereof) and one goal for the ``outer
zone'' states. The ``inner zone'' goals contained more aggressive
compliance schedules and sulfur content limits than the ``outer zone''
goals. Nevertheless, states in the ``inner zone'' could choose to
comply with the ``outer zone'' goals if they experienced supply
disruption issues, and the ``Ask'' effectively provided all states
until 2018 to complete the implementation of their low-sulfur fuel
strategies. Consistent with this approach, Pennsylvania indicated in
its regional haze SIP that, ``[b]ased on supply concerns, Pennsylvania
will pursue a strategy that will not be less stringent than the outer
zone strategy and would meet the sulfur content emission limits listed
above by 2018.'' Therefore, EPA disagrees with the commenter that
Pennsylvania was required to finalize its low-sulfur fuel rule by 2012.
The agreed-upon timeframe in the ``Ask'' provided up to ten years for
adoption and implementation of the various measures.
---------------------------------------------------------------------------

    \6\ See ``Statement of the Mid-Atlantic/Northeast Visibility
Union (MANE-VU) Concerning a Course of Action within MANE-VU toward
Assuring Reasonable Progress'' (January 20, 2007), also known as the
MANE-VU ``Ask,'' in Appendix M of the Pennsylvania regional haze
SIP.
---------------------------------------------------------------------------

    After EPA previously finalized the limited approval of the
Pennsylvania regional haze SIP, Pennsylvania submitted a SIP revision
to EPA that included a low-sulfur fuel rule that met the ``outer
zone''-strategy requirements. EPA proposed to approve this SIP revision
on February 20, 2014. 79 FR 9701. EPA notes that Pennsylvania's low-
sulfur fuel rule does not require that the sulfur content of distillate
oil be reduced to 15 parts per million (ppm) by 2018, as anticipated by
the MANE-VU ``Ask.'' However, for ``outer zone'' states, the
implementation of this requirement was dependent upon supply
availability.\7\ Moreover, as EPA explained in detail in the technical
support document (TSD) \8\ that accompanied our July 13, 2012 final
rule, Pennsylvania has secured an additional 23,051 tons in
SO2 reductions that were not anticipated at the time of the
MANE-VU ``Ask.'' When these reductions are considered in combination
with reductions that will result from Pennsylvania's low-sulfur fuel
rule, EPA believes that a 15 ppm limit on distillate oil is no longer
``appropriate and necessary'' to achieve the goals of the MANE-VU
``Ask'' during the first planning period ending in 2018. Furthermore,
EPA does not believe that Pennsylvania will experience a shortfall in
emission reductions or that approval of the Pennsylvania regional haze
SIP will prevent New Jersey from making reasonable progress at
Brigantine. Finally, while EPA agrees with the third commenter that all
reductions should be enforceable in the SIP itself, EPA believes that
the proposed approval of Pennsylvania's low-sulfur fuel rule SIP
revision largely addresses this concern. Moreover, EPA expects
Pennsylvania to review all of its emission reductions in its five-year
progress report, at which time the additional reductions highlighted in
our TSD can be included in the SIP as enforceable requirements as well.
Consequently, EPA believes that the Pennsylvania regional haze SIP
includes all measures necessary at this time to obtain its share of the
emission reductions needed to meet the RPGs of downwind states and
therefore has met the requirements of 40 CFR 51.308(d)(3)(ii).
---------------------------------------------------------------------------

    \7\ Pennsylvania regional haze SIP, Appendix M (requiring
``outer zone'' states ``to further reduce the sulfur content of
distillate oil to 15 ppm by 2018, depending on supply
availability'').
    \8\ See ``Technical Support Document (TSD) for the Pennsylvania
Regional Haze State Implementation Plan--Mid Atlantic and Northeast
Visibility Union (MANE-VU) `Asks' Reasonable Progress Goals''
(January 17, 2012).
---------------------------------------------------------------------------

    Comment: One commenter asserted that EPA must disapprove the
Pennsylvania regional haze SIP because it failed to include a long-term
strategy with a detailed retirement discussion. The commenter argued
that the Pennsylvania regional haze SIP was inadequate because it
contained no discussion of changes in energy and other markets and
their likely effect on EGUs and non-EGUs. The commenter concluded that
EPA must require a retirement discussion that provides a ``realistic
picture of future emissions from BART-subject sources.''
    Response: EPA disagrees with the commenter that the Pennsylvania
regional haze SIP must be disapproved for failure to include a
retirement discussion in the long-term strategy. Pennsylvania
considered the factors listed in 40 CFR 51.308(d)(3)(v) when developing
its long-term strategy, as

described in detail in our January 26, 2012 proposal. Pennsylvania
included source retirement and replacement schedules as part of the
emissions inventory that it used to project future conditions and
provide a realistic estimate of future visibility impairing emissions
from the identified sources. At the time that Pennsylvania's analyses
were completed, they were based on the best information available. The
projected inventories for 2018 account for post-2002 emissions
reductions from promulgated and proposed federal, state, local, and
site-specific control programs. Pennsylvania developed its long-term
strategy in coordination with the MANE-VU, identifying the emissions
units within Pennsylvania that have the largest impacts on visibility
at the MANE-VU Class I areas, estimating emissions reductions for 2018,
based on all controls required under Federal and state regulations for
the 2002-2018 period (including BART), and comparing projected
visibility improvement with the uniform rate of progress for the MANE-
VU Class I areas. Pennsylvania's long-term strategy includes measures
needed to achieve its share of emissions reductions agreed upon through
the consultation process with Class I area states and includes
enforceable emissions limitations, compliance schedules, and other
measures necessary to achieve the RPGs established by MANE-VU for the
Class I areas.
    These projections can be expected to change as additional
information regarding future conditions becomes available. For example,
new sources may be built, existing sources may shut down or modify
production in response to changed economic circumstances, and
facilities may change their emissions characteristics as they install
control equipment to comply with new rules. To address these
situations, the Regional Haze Rule calls for a five-year progress
review after submittal of the initial regional haze SIP. See 40 CFR
51.308(g). The purpose of this progress review is to assess the
effectiveness of emissions management strategies in meeting RPGs and to
provide an assessment of whether current implementation strategies are
sufficient for the state or affected states to meet their RPGs. If a
state concludes, based on its assessment, that the RPGs for a Class I
area will not be met, the Regional Haze Rule requires the state to take
appropriate action. See 40 CFR 52.308(h). The nature of the appropriate
action will depend on the basis for the state's conclusion that the
current strategies are insufficient to meet the RPGs. Pennsylvania
specifically committed to follow this process in its long-term
strategy.\9\
---------------------------------------------------------------------------

    \9\ Pennsylvania also stated in its regional haze SIP that
retirement and replacement would be managed in conformance with
existing SIP requirements pertaining to new source review.
---------------------------------------------------------------------------

III. Summary of Final Action

    EPA is re-finalizing its limited approval of the Pennsylvania
regional haze SIP, which was submitted on December 20, 2010 to address
regional haze for the first implementation period. EPA is issuing a
limited approval of the Pennsylvania regional haze SIP because,
overall, the Pennsylvania SIP will be stronger and more protective of
the environment with the implementation, Federal approval, and
enforceability of its measures than it would without those measures.
EPA has already finalized a limited disapproval of the Pennsylvania
regional haze SIP in a separate rulemaking. See 77 FR 33642.

IV. Statutory and Executive Order Reviews

A. General Requirements

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

B. Submission to Congress and the Comptroller General

    The Congressional Review Act, 5 U.S.C. 801 et seq., as added by the
Small Business Regulatory Enforcement Fairness Act of 1996, generally
provides that before a rule may take effect, the agency promulgating
the rule must submit a rule report, which includes a copy of the rule,
to each House of the Congress and to the Comptroller General of the
United States. EPA will submit a report containing this action and
other required information to the U.S. Senate, the U.S. House of
Representatives, and the Comptroller General of the United States prior
to publication of the rule in the Federal Register. A major rule cannot
take effect until 60 days after it is published in the Federal
Register. This action is not a ``major rule'' as defined by 5 U.S.C.
804(2).

C. Petitions for Judicial Review

    Under section 307(b)(1) of the CAA, petitions for judicial review
of this action must be filed in the United States Court of Appeals for
the appropriate circuit by June 30, 2014. Filing a petition for
reconsideration by the Administrator of this final rule does not affect
the finality of this action for the purposes of judicial review nor
does it extend the time within which a petition for judicial review may
be filed, and shall not postpone the effectiveness of such rule or
action. This action finalizing the limited approval of the Pennsylvania
Regional Haze SIP may

not be challenged later in proceedings to enforce its requirements. See
section 307(b)(2) of the CAA.

List of Subjects in 40 CFR Part 52

    Environmental protection, Air pollution control, Incorporation by
reference, Nitrogen dioxide, Particulate matter, Reporting and
recordkeeping requirements, Sulfur oxides, Volatile organic compounds.

    Dated: April 11, 2014.
W.C. Early,
Acting, Regional Administrator, Region III.

    40 CFR part 52 is amended as follows:

PART 52--APPROVAL AND PROMULGATION OF IMPLEMENTATION PLANS

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

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

Subpart NN--Pennsylvania

0
2. In Sec.  52.2020, the table in paragraph (e)(1) is amended by
revising the entry for ``Regional Haze Plan'' to read as follows:

Sec.  52.2020  Identification of plan.

* * * * *
    (e) * * *
    (1) * * *

----------------------------------------------------------------------------------------------------------------
   Name of non- regulatory SIP        Applicable        State submittal                           Additional
            revision                geographic area          date          EPA approval date      explanation
----------------------------------------------------------------------------------------------------------------

                                                  * * * * * * *
Regional Haze Plan..............  Statewide.........  12/20/10..........  7/13/12, 77 FR      Sec.   52.2042;
                                                                           41279.              Limited Approval.
                                                      12/20/10..........  4/30/14 [Insert     Reissuing of
                                                                           page number where   Limited Approval.
                                                                           the document
                                                                           begins].

                                                  * * * * * * *
----------------------------------------------------------------------------------------------------------------

* * * * *
[FR Doc. 2014-09726 Filed 4-29-14; 8:45 am]
BILLING CODE 6560-50-P


[Federal Register Volume 86, Number 92 (Friday, May 14, 2021)]
[Notices]
[Pages 26599-26600]
[FR Doc No: 2021-09994]

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DEPARTMENT OF TRANSPORTATION

Federal Aviation Administration

Notice of Intent To Rule on Request for Disposal of 5.1 Acres of
Land at Dillant-Hopkins Airport, Swanzey, NH

AGENCY: Federal Aviation Administration (FAA), DOT.

ACTION: Request for public comments.

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SUMMARY: Notice is being given that the FAA is considering a request
from the City of Keene, NH to dispose of 5.1 acres of land Dillant-
Hopkins Airport, Swanzey, NH. The notice is required under the 2018 FAA
Reauthorization Act, Airport Improvement Program. The land is not
required for aeronautical use. Given its location, the disposal of land
will not affect existing or future aviation development at the airport.
An avigation easement will be placed on the property to ensure
conformance with airport airspace requirements. The regulations require
that 90% of the proceeds be reinvested in federal grant program. The
remaining 10% will be placed in the airport's operating and maintenance
fund.

DATES: Comments must be received on or before June 14, 2021.

ADDRESSES: You may send comments using any of the following methods:
     Federal eRulemaking Portal: Go to http://www.regulations.gov, and follow the instructions on providing comments.
     Fax:<PHONE_NUMBER>.
     Mail: U.S. Department of Transportation, Docket
Operations, M-30, West Building Ground Floor, Room W 12-140, 1200 New
Jersey Avenue SE, Washington, DC 20590.
     Hand Delivery: Deliver to mail address above between 9
a.m. and 5 p.m., Monday through Friday, except Federal holidays.
    Interested persons may inspect the request and supporting documents
by contacting the FAA at the address listed under FOR FURTHER
INFORMATION CONTACT.

FOR FURTHER INFORMATION CONTACT: Mr. Jorge E. Panteli, Compliance and
Land Use Specialist, Federal Aviation Administration New England Region
Airports Division, 1200 District Avenue, Burlington, Massachusetts
01803. Telephone:<PHONE_NUMBER>.

    Issued in Burlington, Massachusetts, on May 6, 2021.
Julie Seltsam-Wilps,
Deputy Director.
[FR Doc. 2021-09994 Filed 5-13-21; 8:45 am]
BILLING CODE P


[Federal Register Volume 82, Number 131 (Tuesday, July 11, 2017)]
[Notices]
[Pages 31974-31976]
[FR Doc No: 2017-14454]

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

Food and Drug Administration

[Docket Nos. FDA-2015-E-4727 and FDA-2015-E-4615]

Determination of Regulatory Review Period for Purposes of Patent
Extension; Intercept Blood System for Plasma

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice.

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

SUMMARY: The Food and Drug Administration (FDA) has determined the
regulatory review period for INTERCEPT BLOOD SYSTEM FOR PLASMA and is
publishing this notice of that determination as required by law. FDA
has made the determination because of the submission of applications to
the Director of the U.S. Patent and Trademark Office (USPTO),
Department of Commerce, for the extension of a patent which claims that
medical device.

DATES: Anyone with knowledge that any of the dates as published (in the
SUPPLEMENTARY INFORMATION section) are incorrect may submit either
electronic or written comments and ask for a redetermination by
September 11, 2017. 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 January 8,
2018. 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. Electronic comments
must be submitted on or before September 11, 2017. The https://www.regulations.gov electronic filing system will accept comments until
midnight Eastern Time at the end of September 11, 2017. Comments
received by mail/hand delivery/courier (for written/paper submissions)
will be considered timely if they are postmarked or the delivery

service acceptance receipt is 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 Nos.
FDA-2015-E-4727 and FDA-2015-E-4615 for ``Determination of Regulatory
Review Period for Purposes of Patent Extension; INTERCEPT BLOOD SYSTEM
FOR PLASMA.'' 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.
     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 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.gpo.gov/fdsys/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.

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 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 medical devices, the testing
phase begins with a clinical investigation of the device and runs until
the approval phase begins. The approval phase starts with the initial
submission of an application to market the device and continues until
permission to market the device is granted. Although only a portion of
a regulatory review period may count toward the actual amount of
extension that the Director of USPTO may award (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 medical device will include all of the
testing phase and approval phase as specified in 35 U.S.C.
156(g)(3)(B).
    FDA has approved for marketing the medical device INTERCEPT BLOOD
SYSTEM FOR PLASMA. INTERCEPT BLOOD SYSTEM FOR PLASMA is indicated for
inactivation of bacterial and viral contaminants in Fresh Frozen Plasma
prior to transfusion. Subsequent to this approval, the USPTO received
patent term restoration applications for INTERCEPT BLOOD SYSTEM FOR
PLASMA (U.S. Patent Nos. 5,593,823 and 6,951,713) from Cerus
Corporation, and the USPTO requested FDA's assistance in determining
this patents' eligibility for patent term restoration. In a letter
dated April 26, 2016, FDA advised the USPTO that this medical device
had undergone a regulatory review period and that the approval of
INTERCEPT BLOOD SYSTEM FOR PLASMA 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
INTERCEPT BLOOD SYSTEM FOR PLASMA is 6,497 days. Of this time, 6,114
days occurred during the testing phase of the regulatory review period,
while 383 days occurred during the approval phase. These periods of
time were derived from the following dates:
    1. The date an exemption under section 520(g) of the Federal Food,
Drug, and Cosmetic Act (the FD&C Act) (21 U.S.C. 360j(g)) involving
this device became effective: March 5, 1997. The applicant claims that
the investigational device exemption (IDE) required under section
520(g) of the FD&C Act for

human tests to begin became effective on March 10, 1997. However, FDA
records indicate that the IDE was determined substantially complete for
clinical studies to have begun on March 5, 1997, which represents the
IDE effective date.
    2. The date an application was initially submitted with respect to
the biological device under section 515 of the FD&C Act (21 U.S.C.
360e): November 29, 2013. The applicant claims December 23, 2013, as
the date the premarket approval application (PMA) for INTERCEPT BLOOD
SYSTEM FOR PLASMA (PMA BP130076) was initially submitted. However, FDA
records indicate that the complete PMA BP130076 was submitted on
November 29, 2013.
    3. The date the application was approved: December 16, 2014. FDA
has verified the applicant's claim that PMA BP130076 was approved on
December 16, 2014.
    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 applications for patent extension,
this applicant seeks 1,860 days or 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 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 be timely (see DATES) and contain sufficient facts to
merit an FDA investigation. (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 (see ADDRESSES).

    Dated: July 5, 2017.
Anna K. Abram,
Deputy Commissioner for Policy, Planning, Legislation, and Analysis.
[FR Doc. 2017-14454 Filed 7-10-17; 8:45 am]
 BILLING CODE 4164-01-P


[Federal Register: April 2, 2009 (Volume 74, Number 62)]
[Notices]
[Page 14981]
[DOCID:fr02ap09-51]

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DEPARTMENT OF ENERGY

Federal Energy Regulatory Commission

[Docket No. RM98-1-000]

Records Governing Off-the Record Communications; Public Notice

March 27, 2009.
    This constitutes notice, in accordance with 18 CFR 385.2201(b), of
the receipt of prohibited and exempt off-the-record communications.
    Order No. 607 (64 FR 51222, September 22, 1999) requires Commission
decisional employees, who make or receive a prohibited or exempt off-
the-record communication relevant to the merits of a contested
proceeding, to deliver to the Secretary of the Commission, a copy of
the communication, if written, or a summary of the substance of any
oral communication.
    Prohibited communications are included in a public, non-decisional
file associated with, but not a part of, the decisional record of the
proceeding. Unless the Commission determines that the prohibited
communication and any responses thereto should become a part of the
decisional record, the prohibited off-the-record communication will not
be considered by the Commission in reaching its decision. Parties to a
proceeding may seek the opportunity to respond to any facts or
contentions made in a prohibited off-the-record communication, and may
request that the Commission place the prohibited communication and
responses thereto in the decisional record. The Commission will grant
such a request only when it determines that fairness so requires. Any
person identified below as having made a prohibited off-the-record
communication shall serve the document on all parties listed on the
official service list for the applicable proceeding in accordance with
Rule 2010, 18 CFR 385.2010.
    Exempt off-the-record communications are included in the decisional
record of the proceeding, unless the communication was with a
cooperating agency as described by 40 CFR 1501.6, made under 18 CFR
385.2201(e) (1) (v).
    The following is a list of off-the-record communications recently
received by the Secretary of the Commission. The communications listed
are grouped by docket numbers in ascending order. These filings are
available for review at the Commission in the Public Reference Room or
may be viewed on the Commission's Web site at http://www.ferc.gov using
the eLibrary link. Enter the docket number, excluding the last three
digits, in the docket number field to access the document. For
assistance, please contact FERC, Online Support at
<EMAIL_ADDRESS>or toll free at<PHONE_NUMBER>, or for TTY,
contact<PHONE_NUMBER>.
    Exempt:

------------------------------------------------------------------------
                                                       Presenter or
             Docket No.               File date          requester
------------------------------------------------------------------------
1. CP07-444-000....................      3-23-09  Todd Tamura\1\
2. Project No. 2677-019............      3-25-09  Marty Sneen \2\
------------------------------------------------------------------------
\1\ Record of email correspondence and attachments.
\2\ Email exchange.

Kimberly D. Bose,
Secretary.
 [FR Doc. E9-7439 Filed 4-1-09; 8:45 am]