[Federal Register: July 31, 2009 (Volume 74, Number 146)]
[Rules and Regulations]
[Page 38102-38107]
[DOCID:fr31jy09-6]

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ENVIRONMENTAL PROTECTION AGENCY

40 CFR Part 52

[EPA-R06-OAR-2009-0214; FRL-8939-4]

Approval and Promulgation of Air Quality Implementation Plans;
Texas; Control of Emissions of Nitrogen Oxides (NOX)

AGENCY: Environmental Protection Agency (EPA).

ACTION: Direct final rule.

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SUMMARY: The EPA is taking a direct final action to approve revisions
to the Texas State Implementation Plan (SIP). We are approving
revisions to 30 TAC Chapter 117, ``Control of Air Pollution from
Nitrogen Compounds,'' that the State submitted on March 10, 2009. These
revisions amend the Beaumont-Port Arthur (BPA) 8-Hour Ozone
Nonattainment Area Major Source rules, the Houston-Galveston-Brazoria
(HGB) 8-Hour Ozone Nonattainment Area Major Source rules, and the HGB
8-Hour Ozone Nonattainment Area Minor Source rules. These revisions add
flexibility and consistency to the current stationary reciprocating
internal combustion engine and gas turbine monitoring specifications
found in Chapter 117 by allowing for an additional option for
monitoring nitrogen oxides (NOX) emissions. These revisions
are consistent with the Clean Air Act (CAA). Therefore, EPA is
approving these revisions pursuant to section 110 of the CAA.

DATES: This direct final rule will be effective September 29, 2009
without further notice unless EPA receives relevant adverse comments by
August 31, 2009. If adverse comments are received, EPA will publish a
timely withdrawal of the direct final rule in the Federal Register
informing the public that the rule will not take effect.

ADDRESSES: Submit your comments, identified by Docket No. EPA-R06-OAR-
2009-0214, by one of the following methods:
     Federal e-Rulemaking Portal: http://www.regulations.gov.
Please follow the online instructions for submitting comments.
     EPA Region 6 ``Contact Us'' Web site: http://epa.gov/
region6/r6comment.htm. Please click on ``6PD (Multimedia)'' and select
``Air'' before submitting comments.
     E-mail: Mr. Guy Donaldson at<EMAIL_ADDRESS>Please
also send a copy by e-mail to the person listed in the FOR FURTHER
INFORMATION CONTACT section below.
     Fax: Mr. Guy Donaldson, Chief, Air Planning Section (6PD-
L), at fax number<PHONE_NUMBER>.
     Mail: Mr. Guy Donaldson, Chief, Air Planning Section (6PD-
L), Environmental Protection Agency, 1445 Ross Avenue, Suite 1200,
Dallas, Texas 75202-2733.
     Hand or Courier Delivery: Mr. Guy Donaldson, Chief, Air
Planning Section (6PD-L), Environmental Protection Agency, 1445 Ross
Avenue, Suite 1200, Dallas, Texas 75202-2733. Such deliveries are
accepted only between the hours of 8 a.m. and 4 p.m. weekdays, and not
on legal holidays. Special arrangements should be made for deliveries
of boxed information.
    Instructions: Direct your comments to Docket No. EPA-R06-OAR-2009-
0214. EPA's policy is that all comments received will be included in
the public docket without change and may be made available online at
http://www.regulations.gov, including any personal information
provided, unless the comment includes information claimed to be
Confidential Business Information (CBI) or other information whose
disclosure is restricted by statute. Do not submit information that you
consider to be CBI or otherwise protected through http://
www.regulations.gov or e-mail. The http://www.regulations.gov Web site
is an ``anonymous access'' system, which means EPA will not know your
identity or contact information unless you provide it in the body of
your comment. If you send an e-mail comment directly to EPA without
going through http://www.regulations.gov your e-mail address will be
automatically captured and included as part of the comment that is
placed in the public docket and made available on the Internet. If you
submit an electronic comment, EPA recommends that you include your name
and other contact information in the body of your comment and with any
disk or CD-ROM you submit. If EPA cannot read your comment due to
technical difficulties and cannot contact you for clarification, EPA
may not be able to consider your comment. Electronic files should avoid
the use of special characters, any form of encryption, and be free of
any defects or viruses.
    Docket: All documents in the docket are listed in the http://
www.regulations.gov index. Although listed in the index, some
information is not publicly available, e.g., CBI or other information
whose disclosure is restricted by statute. Certain other material, such
as copyrighted material, will be publicly available only in hard copy.
Publicly available docket materials are available either electronically
in http://www.regulations.gov or in hard copy at the Air Planning
Section (6PD-L), Environmental Protection Agency, 1445 Ross Avenue,
Suite 700, Dallas, Texas 75202-2733. The file will be made available by
appointment for public inspection in the Region 6 FOIA Review Room
between the hours of 8:30 a.m. and 4:30 p.m. weekdays except for legal
holidays. Contact the person listed in the FOR FURTHER INFORMATION
CONTACT paragraph below or Mr. Bill Deese at<PHONE_NUMBER> to make an
appointment. If possible, please make the appointment at least two
working days in advance of your visit. There will be a fee of 15 cents
per page for making photocopies of documents. On the day of the visit,
please check in at the EPA Region 6 reception area at 1445 Ross Avenue,
Suite 700, Dallas, Texas.
    The State submittal is also available for public inspection during
official business hours, by appointment, at the Texas Commission on
Environmental Quality (TCEQ), Office of Air Quality, 12124 Park 35
Circle, Austin, Texas 78753.

FOR FURTHER INFORMATION CONTACT: Dayana Medina, Air Planning Section
(6PD-L), Environmental Protection Agency, Region 6, 1445 Ross Avenue,
Suite 700, Dallas, Texas 75202-2733, telephone<PHONE_NUMBER>; fax number
214-665-7263; e-mail address<EMAIL_ADDRESS>
SUPPLEMENTARY INFORMATION: Throughout this document, ``we,'' ``us,''
and ``our'' means EPA.

Outline

I. Background
    A. What Action Is EPA Taking?
    B. What Are NOX?
    C. What Is Ozone, and Why Do We Regulate It?
    D. What Is a SIP?
    E. What Did the State Submit?
    1. Beaumont-Port Arthur 8-Hour Ozone Nonattainment Area Major
Sources
    2. Houston-Galveston-Brazoria 8-Hour Ozone Nonattainment Area
Major Sources
    3. Houston-Galveston-Brazoria 8-Hour Ozone Nonattainment Area
Minor Sources
II. Final Action
III. Statutory and Executive Order Reviews

I. Background

A. What Action Is EPA Taking?

    Today we are approving revisions to the Texas SIP that amend 30 TAC
Chapter 117, Control of Air Pollution from Nitrogen Compounds. These
revisions amend the BPA 8-Hour Ozone Nonattainment Area Major Source
rules, the HGB 8-Hour Ozone Nonattainment Area Major Source rules, and
the HGB 8-Hour Ozone Nonattainment Area Minor Source rules, as
submitted by the TCEQ to EPA on March 10, 2009. These revisions are
substantive in nature, allowing for an additional option for monitoring
nitrogen oxides (NOX) emissions. This will result in
additional flexibility and consistency in the current stationary
reciprocating internal combustion engine and gas turbine monitoring
specifications found in Chapter 117. This additional option is expected
to be equally effective as totalizing fuel flow meters in the
monitoring of NOX emissions at major stationary sources in
the BPA 8-hour ozone nonattainment area and at both major and minor
stationary sources in the HGB 8-hour ozone nonattainment area. We are
approving these revisions in accordance with section 110 of the CAA.
    The EPA is publishing this rule without prior proposal because we
view this as a noncontroversial amendment and anticipate no relevant
adverse comments. However, in the proposed rules section of this
Federal Register publication, we are publishing a separate document
that will serve as the proposal to approve the SIP revisions if
relevant adverse comments are received. This rule will be effective on
September 29, 2009 without further notice unless we receive relevant
adverse comment by August 31, 2009. If we receive relevant adverse
comments, we will publish a timely withdrawal in the Federal Register
informing the public that the rule will not take effect. We will
address all public comments in a subsequent final rule based on the
proposed rule. We will not institute a second comment period on this
action. Any parties interested in commenting must do so now. Please
note that if we receive adverse comment on an amendment, paragraph, or
section of this rule and if that provision may be severed from the
remainder of the rule, we may adopt as final those provisions of the
rule that are not the subject of an adverse comment.

B. What Are NOX?

    Nitrogen oxides (NOX) belong to the group of criteria
air pollutants. NOX are produced from burning fuels,
including gasoline and coal. Nitrogen oxides react with volatile
organic compounds (VOC) to form ground-level ozone or smog, and are
also major components of acid rain. For more information on
NOX see http://www.epa.gov/air/urbanair/nox/.

C. What Is Ozone, and Why Do We Regulate It?

    Ozone is a gas composed of three oxygen atoms. Ground-level ozone
is generally not emitted directly from a vehicle's exhaust or an
industrial smokestack, but is created by a chemical reaction between
NOX and VOCs in the presence of sunlight and high ambient
temperatures. Thus, ozone is known primarily as a summertime air
pollutant. NOX and VOCs are precursors of ozone. Motor
vehicle exhaust and industrial emissions, gasoline vapors, chemical
solvents and natural sources emit NOX and VOCs. Urban areas
tend to have high concentrations of ground-level ozone, but areas
without significant industrial activity and with relatively low
vehicular traffic are also subject to increased ozone levels because
wind carries ozone and its precursors hundreds of miles from their
sources.
    Repeated exposure to ozone pollution may cause lung damage. Even at
very low concentrations, ground-level ozone triggers a variety of
health problems including aggravated asthma, reduced lung capacity, and
increased susceptibility to respiratory illnesses like pneumonia and
bronchitis. It can also have detrimental effects on plants and
ecosystems.

D. What Is a SIP?

    Section 110 of the CAA requires States to develop air pollution
regulations and control strategies to ensure that air quality meets the
National Ambient Air Quality Standards (NAAQS) established by EPA. The
NAAQS are established under section 109 of the CAA and currently
address six criteria pollutants: carbon monoxide, nitrogen dioxide,
ozone, lead, particulate matter, and sulfur dioxide. A SIP is a set of
air pollution regulations, control strategies, other means or
techniques, and technical analyses developed by the State, to ensure
that air quality in the State meets the NAAQS. A SIP protects air
quality primarily by addressing air pollution at its point of origin. A
SIP can be extensive, containing State regulations or other enforceable
documents, and supporting information such as emissions inventories,
monitoring networks, and modeling demonstrations. Each State must
submit regulations and control strategies to EPA for approval and
incorporation into the Federally-enforceable SIP.

E. What Did the State Submit?

    Table A below contains a summary list of sections in 30 TAC Chapter
117 that we are approving into the Texas SIP with this rulemaking
action.

  Table A--30 TAC Chapter 117--Section Numbers and Section Descriptions
                       Affected by This Rulemaking
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         Section No.                          Description
------------------------------------------------------------------------
Section 117.140..............  Continuous Demonstration of Compliance.
Section 117.145..............  Notification, Recordkeeping, and
                                Reporting Requirements.
Section 117.340..............  Continuous Demonstration of Compliance.
Section 117.345..............  Notification, Recordkeeping, and
                                Reporting Requirements.
Section 117.2035.............  Monitoring and Testing Requirements.
Section 117.2045.............  Recordkeeping and Reporting Requirements.
------------------------------------------------------------------------

    For more information, see sections E(1), E(2), and E(3) of this
document.
1. Beaumont-Port Arthur 8-Hour Ozone Nonattainment Area Major Sources
    The BPA 8-Hour Ozone Nonattainment Area Major Source rules are
found in 30 TAC Chapter 117, Control of Air Pollution from Nitrogen
Compounds; Subchapter B, Combustion Control at Major Industrial,
Commercial, and Institutional Sources in Ozone Nonattainment Areas;
Division 1, Beaumont-Port Arthur Ozone Nonattainment Area Major
Sources. Revisions to the BPA 8-Hour Ozone Nonattainment Area Major
Source rules were adopted by the State on February 11, 2009, and
submitted to EPA for approval into the SIP on March 10, 2009. We
provided comments to TCEQ concerning the SIP revision in a letter dated
September 15, 2008. Our comment letter to TCEQ is a part of the docket
for this rulemaking action and available for public inspection.
    Section 117.140 (Continuous Demonstration of Compliance) currently
requires stationary reciprocating internal combustion engines and
stationary gas turbines located at major sources of NOX in
the BPA 8-hour ozone nonattainment area to have a fuel flow meter
installed. The totalizing fuel flow meter is used to measure the
activity rate of the engine, and the activity rate is used as an
indirect indication of NOX emissions from these sources. The
revision to section 117.140(a)(2) that we are approving adds new
subparagraph (D), providing an output-based monitoring alternative to
the totalizing fuel flow meter requirement and thereby adding
monitoring flexibility for owners and operators of the affected units.
New subparagraph (D) reads as follows: ``Stationary reciprocating
internal combustion engines and stationary gas turbines equipped with a
continuous monitoring system that continuously monitors horsepower and
hours of operation are not required to install totalizing fuel flow
meters. The continuous monitoring system must be installed, calibrated,
maintained, and operated according to manufacturers' recommended
procedures.'' The EPA is approving this revision because we consider
continuous monitoring of horsepower output and hours of operation to be
as effective as monitoring of fuel flow in the indirect indication of
NOX emissions. Both methods monitor the activity rate of the
engine, and these measures are used to indirectly determine
NOX emissions. In addition, this revision is consistent with
an option currently allowed under section 117.440(a)(2)(D) for engines
in the Dallas-Fort Worth (DFW) 8-hour ozone nonattainment area, which
we approved on December 3, 2008 (73 FR 73562).
    The revision to section 117.145 (Notification, Recordkeeping, and
Reporting Requirements) adds a new paragraph (10) to subsection (f),
specifying recordkeeping requirements. Existing section 117.145(f)
consists of the recordkeeping requirements for units subject to
Division 1 (Beaumont-Port Arthur Ozone Nonattainment Area Major
Sources). Existing subsection (f) directs owners or operators of
subject units to maintain written or electronic records of specified
data for a period of at least five years and make available upon
request by authorized representatives of the executive director of the
TCEQ, the EPA, or local air pollution control agencies having
jurisdiction. New paragraph (10) in section 117.145(f), concerning the
recordkeeping requirements of output-based monitoring data, reads that
the records specified in subsection (f) must include ``for each
stationary reciprocating internal combustion engine and stationary gas
turbine for which the owner or operator elects to use the alternative
monitoring system allowed under section 117.140(a)(2)(D) of this title,
records of the daily average horsepower and total daily hours of
operation. Units that are monitored according to section
117.140(a)(2)(D) of this title are not required to keep records of
annual fuel usage as required by paragraph (1) of this subsection.''
New paragraph (10) in section 117.145(f) will ensure that recordkeeping
requirements are consistent with the horsepower and hours of operation
data that would be collected by the output-based alternative monitoring
provision found in new subparagraph (D) of section 117.140(a)(2). The
EPA is approving this revision because it will provide for appropriate/
accurate recordkeeping and reporting of records for each affected
stationary reciprocating internal combustion engine and stationary gas
turbine utilizing the output-based alternative monitoring system
provision.
2. Houston-Galveston-Brazoria 8-Hour Ozone Nonattainment Area Major
Sources
    The HGB 8-Hour Ozone Nonattainment Area Major Source rules are
found in 30 TAC Chapter 117, Control of Air Pollution from Nitrogen
Compounds; Subchapter B, Combustion Control at Major Industrial,
Commercial, and Institutional Sources in Ozone Nonattainment Areas;
Division 3, Houston-Galveston-Brazoria Ozone Nonattainment Area Major
Sources. Revisions to the HGB 8-Hour Ozone Nonattainment Area Major
Source rules were adopted by the State on February 11, 2009 and
submitted to EPA for approval into the SIP on March 10, 2009. We
provided comments to TCEQ concerning the SIP revision in a letter dated
September 15, 2008. Our comment letter to TCEQ is a part of the docket
for this rulemaking action and available for public inspection.
    Section 117.340 (Continuous Demonstration of Compliance) currently
requires stationary reciprocating internal combustion engines and
stationary gas turbines located at major sources of NOX in
the HGB 8-hour ozone nonattainment area to have a fuel flow meter
installed. The totalizing fuel flow meter is used to measure the
activity rate of the engine, and the activity rate is used as an
indirect indication of NOX emissions from these sources. The
revision to section 117.340(a)(2) that we are approving adds new
subparagraph (D), providing an output-based monitoring alternative to
the totalizing fuel flow meter requirement and thereby adding
monitoring flexibility for owners and operators of the affected units.
New subparagraph (D) reads as follows: ``Stationary reciprocating
internal combustion engines and stationary gas turbines equipped with a
continuous monitoring system that continuously monitors horsepower and
hours of operation are not required to install totalizing fuel flow
meters. The continuous monitoring system must be installed, calibrated,
maintained, and operated according to manufacturers' recommended
procedures.'' The EPA is approving this revision because we consider
continuous monitoring of horsepower output and hours of operation to be
as effective as a totalizing fuel flow meter in the indirect indication
of NOX emissions. Both methods monitor the activity rate of
the engine, and these measures are used to indirectly determine
NOX emissions. The output-based monitoring alternative
provides activity data equivalent with the existing monitoring
specifications and can easily be converted into an annual mass emission
rate for compliance with the MECT program.\1\ In

addition, this revision is consistent with an option currently allowed
under section 117.440(a)(2)(D) for engines in the DFW 8-hour ozone
nonattainment area, which we approved on December 3, 2008 (73 FR
73562).
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    \1\ During the comment period, we provided comments to TCEQ
concerning the SIP revision in a letter dated September 15, 2008. In
the letter, EPA noted that NOX emitting facilities in the
HGB area are subject to the Mass Emissions Cap and Trade (MECT)
program. We asked the TCEQ to explain how a source in the HGB area
which elects to use the output-based monitoring alternative option
would be able to determine its mass emissions to show compliance
with the MECT. Our letter and the TCEQ's response can be found in
the State's submittal, which is in the docket for this rulemaking
action.
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    The revision to Section 117.345 (Notification, Recordkeeping, and
Reporting Requirements) adds a new paragraph (12) to subsection (f),
specifying recordkeeping requirements. Existing section 117.345(f)
consists of the recordkeeping requirements for units subject to
Division 3 (Houston-Galveston-Brazoria Ozone Nonattainment Area Major
Sources). Existing subsection (f) directs owners or operators of
subject units to maintain written or electronic records of specified
data for a period of at least five years and make available upon
request by authorized representatives of the executive director of the
TCEQ, the EPA, or local air pollution control agencies having
jurisdiction. New paragraph (12) in section 117.345(f), which specifies
the recordkeeping requirements of output-based monitoring data, reads
that the records specified in subsection (f) must include ``for each
stationary reciprocating internal combustion engine and stationary gas
turbine for which the owner or operator elects to use the alternative
monitoring system allowed under section 117.340(a)(2)(D) of this title,
records of the daily average horsepower and total daily hours of
operation. Units that are monitored according to section
117.340(a)(2)(D) of this title are not required to keep records of
annual fuel usage as required by paragraph (1) of this subsection.''
New paragraph (12) in section 117.345(f) will ensure that recordkeeping
requirements are consistent with the horsepower and hours of operation
data that would be collected by the output-based alternative monitoring
provision found in new subparagraph (D) of section 117.340(a)(2). The
EPA is approving this revision because it will provide for appropriate/
accurate recordkeeping and reporting of records for each affected
stationary reciprocating internal combustion engine and stationary gas
turbine utilizing the output-based alternative monitoring system
provision.
3. Houston-Galveston-Brazoria 8-Hour Ozone Nonattainment Area Minor
Sources
    The HGB 8-Hour Ozone Nonattainment Area Minor Source rules are
found in 30 TAC Chapter 117, Control of Air Pollution from Nitrogen
Compounds; Subchapter D, Combustion Control at Minor Sources in Ozone
Nonattainment Areas; Division 1, Houston-Galveston-Brazoria Ozone
Nonattainment Area Minor Sources. Revisions to the HGB 8-Hour Ozone
Nonattainment Area Minor Source rules were adopted by the State on
February 11, 2009 and submitted to EPA for approval into the SIP on
March 10, 2009. We provided comments to TCEQ concerning the SIP
revision in a letter dated September 15, 2008. Our comment letter to
TCEQ is a part of the docket for this rulemaking action and available
for public inspection.
    Section 117.2035 (Monitoring and Testing Requirements) currently
requires stationary reciprocating internal combustion engines and
stationary gas turbines located at minor stationary sources of
NOX in the HGB 8-hour ozone nonattainment area to have a
fuel flow meter installed. The totalizing fuel flow meter is used to
measure the activity rate of the engine, which is used as an indirect
indication of NOX emissions from these sources. The revision
to section 117.2035(a)(2) that we are approving adds a new subparagraph
(G), providing an output-based monitoring alternative for stationary
reciprocating internal combustion engines and stationary gas turbines
and thereby adding monitoring flexibility for the owners and operators
of the affected units. New subparagraph (G) reads as follows:
``Stationary reciprocating internal combustion engines and stationary
gas turbines equipped with a continuous monitoring system that
continuously monitors horsepower and hours of operation are not
required to install totalizing fuel flow meters. The continuous
monitoring system must be installed, calibrated, maintained, and
operated according to manufacturer's procedures.'' The EPA is approving
this revision because we consider continuous monitoring of horsepower
output and hours of operation to be as effective as a totalizing fuel
flow meter in the indirect indication of NOX emissions. Both
methods monitor the activity rate of the engine, and these measures are
used to indirectly determine NOX emissions. The output-based
monitoring alternative provides activity data equivalent with the
existing monitoring specifications and can easily be converted into an
annual mass emission rate for compliance with the MECT program. In
addition, this revision is consistent with an option currently allowed
under section 117.440(a)(2)(D) for engines in the DFW 8-hour ozone
nonattainment area, which we approved on December 3, 2008 (73 FR
73562).
    Section 117.2045 concerns Recordkeeping and Reporting Requirements.
The revision to subsection (a) in section 117.2045 adds new paragraph
(7), specifying recordkeeping requirements. Existing section
117.2045(a) consists of the recordkeeping requirements for units
subject to Division 1 (Houston-Galveston-Brazoria Ozone Nonattainment
Area Minor Sources). Existing subsection (a) directs owners or
operators of subject units to maintain written or electronic records of
specified data for a period of at least five years and make available
upon request by authorized representatives of the executive director of
the TCEQ, the EPA, or local air pollution control agencies having
jurisdiction. New paragraph (7) in section 117.2045(a), which specifies
the recordkeeping requirements of output-based monitoring data, reads
that the records specified in subsection (a) must include ``records of
daily average horsepower and total daily hours of operation for each
stationary reciprocating internal combustion engine or stationary gas
turbine that the owner or operator elects to use the alternative
monitoring system allowed under section 117.2035(a)(2)(G) of this
title. Units that are monitored according to section 117.2035(a)(2)(G)
of this title are not required to keep records of annual fuel usage as
required by paragraph (1) of this subsection.'' New paragraph (7) in
section 117.2045(a) ensures that recordkeeping requirements are
consistent with the horsepower and hours of operation data that would
be collected by the output-based alternative monitoring provision found
in new subparagraph (G) of section 117.2035(a)(2). The EPA is approving
this revision because it is necessary to ensure the accurate
recordkeeping and reporting for each stationary reciprocating internal
combustion engine and stationary gas turbine for which the owner or
operator elects to use the output-based alternative monitoring system
allowed under section 117.2035(a)(2)(G). Accurate recordkeeping is
essential for the proper monitoring and control of NOX
emissions, which in turn assists in the improvement of air quality.

II. Final Action

    Today we are approving revisions to 30 TAC Chapter 117 into the
Texas SIP. We are approving revisions to the BPA 8-Hour Ozone
Nonattainment Area Major Source rules, the HGB 8-Hour Ozone
Nonattainment Area Major Source rules, and the HGB 8-Hour

Ozone Nonattainment Area Minor Source rules. We are approving these SIP
revisions, which add flexibility and consistency to the current
stationary reciprocating internal combustion engine and gas turbine
monitoring specifications found in Chapter 117 by allowing for an
additional option for monitoring NOX emissions. We are
approving these revisions pursuant to section 110 of the CAA because
the revisions provide an additional effective monitoring method that
will provide flexibility while maintaining the enforceability of the
rules.

V. Statutory and Executive Order Reviews

    Under the Clean Air Act, the Administrator is required to approve a
SIP submission that complies with the provisions of the Act and
applicable Federal regulations. 42 U.S.C. 7410(k); 40 CFR 52.02(a).
Thus, in reviewing SIP submissions, EPA's role is to approve State
choices, provided that they meet the criteria of the Clean Air Act.
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 Clean Air Act;
     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); and
     Does not have Tribal implications as specified by
Executive Order 13175 (65 FR 67249, November 9, 2000), because the SIP
is not approved to apply in Indian country located in the State, and
EPA notes that it will not impose substantial direct costs on Tribal
governments or preempt Tribal law.
    The Congressional Review Act, 5 U.S.C. 801 et seq., as added by the
Small Business Regulatory Enforcement Fairness Act of 1996, generally
provides that before a rule may take effect, the agency promulgating
the rule must submit a rule report, which includes a copy of the rule,
to each House of the Congress and to the Comptroller General of the
United States. EPA will submit a report containing this action and
other required information to the U.S. Senate, the U.S. House of
Representatives, and the Comptroller General of the United States prior
to publication of the rule in the Federal Register. A major rule cannot
take effect until 60 days after it is published in the Federal
Register. This action is not a ``major rule'' as defined by 5 U.S.C.
804(2).
    Under section 307(b)(1) of the Clean Air Act, petitions for
judicial review of this action must be filed in the United States Court
of Appeals for the appropriate circuit by September 29, 2009. Filing a
petition for reconsideration by the Administrator of this final rule
does not affect the finality of this action for the purposes of
judicial review nor does it extend the time within which a petition for
judicial review may be filed, and shall not postpone the effectiveness
of such rule or action. This action may not be challenged later in
proceedings to enforce its requirements. (See Section 307(b)(2).)

List of Subjects in 40 CFR Part 52

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

    Dated: July 21, 2009.
Carl E. Edlund,
Acting Regional Administrator, Region 6.

0
40 CFR part 52 is amended as follows:

PART 52--[AMENDED]

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

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

Subpart SS--Texas

0
2. The table in Sec.  52.2270(c) entitled ``EPA Approved Regulations in
the Texas SIP'' is amended under ``Chapter 117--Control of Air
Pollution From Nitrogen Compounds'' as follows:
0
a. Under Subchapter B, Division 1, by revising the entries for Sections
117.140 and 117.145;
0
b. Under Subchapter B, Division 3, by revising the entries for Sections
117.340 and 117.345;
0
c. Under Subchapter D, Division 1, by revising the entries for Sections
117.2035 and 117.2045.
    The revisions read as follows:
    Sec.  52.2270 Identification of plan
* * * * *
    (c) * * *

                                    EPA-Approved Regulations in the Texas SIP
----------------------------------------------------------------------------------------------------------------
                                                        State approval/
        State citation               Title/subject         submittal       EPA approval date       Explanation
                                                             date
----------------------------------------------------------------------------------------------------------------

                                                  * * * * * * *
----------------------------------------------------------------------------------------------------------------
                          Chapter 117--Control of Air Pollution From Nitrogen Compounds
----------------------------------------------------------------------------------------------------------------

                                                  * * * * * * *
----------------------------------------------------------------------------------------------------------------
      Subchapter B--Combustion Control at Major Industrial, Commercial, and Institutional Sources in Ozone
                                               Nonattainment Areas
                     Division 1--Beaumont-Port Arthur Ozone Nonattainment Area Major Sources
----------------------------------------------------------------------------------------------------------------

                                                  * * * * * * *
Section 117.140...............  Continuous                   2/11/2009  7/31/2009 [Insert FR
                                 Demonstration of                        page number where
                                 Compliance.                             document begins].
Section 117.145...............  Notification,                2/11/2009  7/31/2009 [Insert FR
                                 Recordkeeping, and                      page number where
                                 Reporting                               document begins].
                                 Requirements.

                                                  * * * * * * *
----------------------------------------------------------------------------------------------------------------
                  Division 3--Houston-Galveston-Brazoria Ozone Nonattainment Area Major Sources
----------------------------------------------------------------------------------------------------------------

                                                  * * * * * * *
Section 117.340...............  Continuous                   2/11/2009  7/31/2009 [Insert FR    ................
                                 Demonstration of                        page number where
                                 Compliance.                             document begins].
Section 117.345...............  Notification,                2/11/2009  7/31/2009 [Insert FR    ................
                                 Recordkeeping, and                      page number where
                                 Reporting                               document begins].
                                 Requirements.

                                                  * * * * * * *
----------------------------------------------------------------------------------------------------------------
                 Subchapter D--Combustion Control at Minor Sources in Ozone Nonattainment Areas
                  Division 1--Houston-Galveston-Brazoria Ozone Nonattainment Area Minor Sources
----------------------------------------------------------------------------------------------------------------

                                                  * * * * * * *
Section 117.2035..............  Monitoring and Testing       2/11/2009  7/31/2009 [Insert FR
                                 Requirements.                           page number where
                                                                         document begins].
Section 117.2045..............  Recordkeeping and            2/11/2009  7/31/2009 [Insert FR
                                 Reporting                               page number where
                                 Requirements.                           document begins].

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

[FR Doc. E9-18345 Filed 7-30-09; 8:45 am]

BILLING CODE 6560-50-P


[Federal Register Volume 76, Number 150 (Thursday, August 4, 2011)]
[Notices]
[Pages 47283-47285]
[FR Doc No: 2011-19740]

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SECURITIES AND EXCHANGE COMMISSION

[Release No. 34-64989; File No. SR-EDGA-2011-23]

Self-Regulatory Organizations; EDGA Exchange, Inc.; Notice of
Filing and Immediate Effectiveness of Proposed Rule Change Relating to
Amendments to the EDGA Exchange, Inc. Fee Schedule

July 29, 2011.
    Pursuant to Section 19(b)(1) of the Securities Exchange Act of 1934
(the ``Act''),\1\ and Rule 19b-4 thereunder,\2\ notice is hereby given
that on July 27, 2011, the EDGA Exchange, Inc. (the ``Exchange'' or the
``EDGA'') filed with the Securities and Exchange Commission
(``Commission'') the proposed rule change as described in Items I, II,
and III below, which items have been prepared by the self-regulatory
organization. The Commission is publishing this notice to solicit
comments on the proposed rule change from interested persons.
---------------------------------------------------------------------------

    \1\ 15 U.S.C. 78s(b)(1).
    \2\ 17 CFR 240.19b-4.
---------------------------------------------------------------------------

I. Self-Regulatory Organization's Statement of the Terms of Substance
of the Proposed Rule Change

    The Exchange proposes to amend its fees and rebates applicable to
Members \3\ of the Exchange pursuant to EDGA Rule 15.1(a) and (c). All
of the changes described herein are applicable to EDGA Members. The
text of the proposed rule change is available on the Exchange's
Internet Web site at http://www.directedge.com.
---------------------------------------------------------------------------

    \3\ A Member is any registered broker or dealer, or any person
associated with a registered broker or dealer, that has been
admitted to membership in the Exchange.
---------------------------------------------------------------------------

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 self-regulatory organization
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 self-regulatory organization
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
    With respect to the category of securities priced at or above
$1.00, when Members add liquidity, they are currently assessed a charge
of $0.00025 per share. Alternatively, when Members remove liquidity,
they are currently rebated in the amount of $0.00015 per share. The
Exchange proposes to amend the fee structure (and related Flags) set
forth in the fee schedule to instead provide a rebate for Members in
the amount of $0.0005 per share when adding liquidity and assess a
$0.0006 per share charge when removing liquidity.
    The Exchange proposes to make conforming changes to the relevant
flags, as described below, for adding and removing liquidity from the
EDGA book. Specifically, the Exchange proposes to: (a) Discontinue the
$0.00025 per share charge for adding liquidity to EDGA book in Tape B
securities (Flag B) and instead offer a rebate of $0.0005 per share;
(b) discontinue the rebate of $0.00015 per share for removing liquidity
from the EDGA book in Tapes B and C securities (Flag N) and instead
assess a $0.0006 per share charge; (c) discontinue the $0.00025 per
share charge for adding liquidity to the EDGA book in Tape A securities
(Flag V) and instead offer a rebate of $0.0005 per share; (d)
discontinue the rebate of $0.00015 per share for removing liquidity
from the EDGA book in Tape A securities (Flag W) and instead assess a
$0.0006 per share charge; (e) discontinue the $0.00025 per share charge
for adding liquidity to the EDGA book in Tape C securities (Flag Y) and
instead offer a rebate of $0.0005 per share; (f) discontinue the
$0.00025 per share charge for adding liquidity in the pre- and post-
market trading sessions in Tapes A and C securities (Flag 3) and
instead offer a rebate of $0.0005 per share; (g) discontinue the
$0.00025 per share charge for adding liquidity in the pre- and post-
market trading sessions in Tape B securities (Flag 4) and instead offer
a rebate of $0.0005 per share; and (h) discontinue the rebate of
$0.00015 per share for removing liquidity in the pre- and post-market
trading sessions in securities on all Tapes (Flag 6) and instead assess
a $0.0006 per share charge.
    The Exchange also proposes to delete, in its entirety, footnote 12,
which describes a tiered rate ($0.00005 per share) if Members, measured
monthly, post 0.9% of the Total Consolidated Volume (``TCV'') in
average daily volume to EDGA. As a result of the deletion of footnote
12, current footnotes 13-14 have been re-numbered as footnotes 12-13.
    Currently, the BY flag is yielded when an order is routed to BATS
BYX Exchange and removes liquidity using order types ROUC, ROBY, ROBB,
or ROCO, as defined in Exchange Rules 11.9(b)(3)(a), (c), and (g). The
Exchange proposes to decrease the rebate from $0.0004 to $0.0002 when
an order is routed to BATS BYX Exchange and removes liquidity.
    The Exchange also proposes to eliminate the text in footnote 7,
which describes the INET tier, and replace it with the words
``intentionally omitted.'' This tier provides that ``Members routing an
average daily volume (``ADV''): (i) Less than 5,000,000 shares will be
charged $0.0030 per share, as described in the schedule; (ii) equal to
or greater than 5,000,000 shares but less than 20,000,000 shares will
be charged Nasdaq's best removal tier rate per share; (iii) equal to or
greater than 20,000,000 shares but less than 30,000,001 shares will be
charged Nasdaq's best removal tier rate--$0.0001 per share; and (iv)
equal to or greater than 30,000,001 shares will be charged Nasdaq's
best removal tier rate--$0.0002 per share. The rates, in all cases, are
calculated for shares removed from Nasdaq.'' Conforming changes have
been made to eliminate the references to footnotes 7 and a on Flags 2
and L, as they are no longer applicable.
    The Exchange proposes to implement these amendments to its fee
schedule on August 1, 2011.
2. Statutory Basis
    The Exchange believes that the proposed rule change is consistent
with the objectives of Section 6 of the Exchange Act,\4\ in general,
and furthers

the objectives of Section 6(b)(4),\5\ in particular, as it is designed
to provide for the equitable allocation of reasonable dues, fees and
other charges among its members and other persons using its facilities.
---------------------------------------------------------------------------

    \4\ 15 U.S.C. 78f.
    \5\ 15 U.S.C. 78f(b)(4).
---------------------------------------------------------------------------

    The Exchange's proposal to provide a rebate of $0.0005 per share
for adding liquidity and assess a charge of $0.0006 per share for
removing liquidity is designed to allow the Exchange to compete with
other market centers, and at the same time preserve its current spread
of $0.0001 per share. Because the Exchange's spread remains at $0.0001
per share under the proposed rate, the Exchange believes the proposed
maker/taker fee spread to be reasonable. The proposed maker/taker
spread is competitive with other market centers maker/taker spreads
(BATS BZX Exchange, $0.0001 per share), Nasdaq ($.001--($.00045) per
share), and NYSE Arca ($0.0009--($0.0002) per share). The Exchange
believes that the proposed rate is non-discriminatory in that it
applies uniformly to all Members.
    Currently, the Exchange has a taker/maker fee structure whereby the
Exchange assesses a fee of $0.00025 per share to add liquidity and
provides a rebate of $0.00015 per share to remove liquidity. By
changing its fee structure to the proposed maker/taker model, the
Exchange will make it less expensive for Members to post liquidity to
EDGA. As a result, EDGA expects to gain market share and see its order
volume increase. Such increased volume increases potential revenue to
the Exchange, and would allow the Exchange to spread its administrative
and infrastructure costs over a greater number of shares, leading to
lower per share costs. These lower per share costs would allow the
Exchange to pass on the savings to Members in the form a rebate. The
increased liquidity also benefits all investors by deepening EDGA's
liquidity pool, supporting the quality of price discovery, promoting
market transparency and improving investor protection.
    The elimination of the tier described in footnote 12 (posting 0.9%
of the TCV in average daily volume to EDGA) results from discussions
with the Exchange's customers whereby the Exchange has concluded that
the tier is not effective at incenting liquidity.
    The Exchange believes that the proposed decrease in rebate
associated with the BY flag (from $0.0004 per share to $0.0002 per
share) represents an equitable allocation of reasonable dues, fees, and
other charges since it reflects a pass through of the BATS fee for
removing liquidity. EDGA believes that it is reasonable and equitable
to pass on these fees to its members. The Exchange believes that the
proposed decrease in rebate is non-discriminatory in that it applies
uniformly to all Members.
    The Exchange believes that the proposed elimination of the INET
tier in footnote 7 represents an equitable allocation of reasonable
dues, fees, and other charges as the INET tier is not used by any
Members and therefore, its elimination will not impact any Members. The
proposed elimination of the tier also provides more simplicity to the
fee schedule.
    The Exchange also notes that it operates in a highly competitive
market in which market participants can readily direct order flow to
competing venues if they deem fee levels at a particular venue to be
excessive. The proposed rule change reflects a competitive pricing
structure designed to incent market participants to direct their order
flow to the Exchange. The Exchange believes that the proposed rates are
equitable and non-discriminatory in that they apply uniformly to all
Members. The Exchange believes the fees and credits remain competitive
with those charged by other venues and therefore continue to be
reasonable and equitably allocated to Members.

B. Self-Regulatory Organization's Statement on Burden on Competition

    The proposed rule change does not impose any burden on competition
that is not necessary or appropriate in furtherance of the purposes of
the Act.

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

    The Exchange has not solicited, and does not intend to solicit,
comments on this proposed rule change. The Exchange has not received
any unsolicited written comments from members or other interested
parties.

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

    The foregoing rule change has become effective pursuant to Section
19(b)(3) of the Act \6\ and Rule 19b-4(f)(2) \7\ thereunder. At any
time within 60 days of the filing of such proposed rule change, the
Commission summarily may temporarily suspend such rule change if it
appears to the Commission that such action is necessary or appropriate
in the public interest, for the protection of investors, or otherwise
in furtherance of the purposes of the Act.
---------------------------------------------------------------------------

    \6\ 15 U.S.C. 78s(b)(3)(A).
    \7\ 17 CFR 19b-4(f)(2).
---------------------------------------------------------------------------

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 e-mail to<EMAIL_ADDRESS>Please include
File Number SR-EDGA-2011-23 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-EDGA-2011-23. This file
number should be included on the subject line if e-mail 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
a.m. and 3 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-EDGA-2011-23 and should be
submitted on or before August 25, 2011.

    For the Commission, by the Division of Trading and Markets,
pursuant to delegated authority.\8\
---------------------------------------------------------------------------

    \8\ 17 CFR 200.30-3(a)(12).
---------------------------------------------------------------------------

Elizabeth M. Murphy,
Secretary.
[FR Doc. 2011-19740 Filed 8-3-11; 8:45 am]
BILLING CODE 8011-01-P


[Federal Register Volume 78, Number 181 (Wednesday, September 18, 2013)]
[Notices]
[Page 57374]
[FR Doc No: 2013-22654]

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

DEPARTMENT OF ENERGY

Federal Energy Regulatory Commission

Combined Notice of Filings

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

Filings Instituting Proceedings

    Docket Numbers: RP13-1320-000.
    Applicants: Transcontinental Gas Pipe Line Company.
    Description: LNG Truck Service to be effective 11/1/2013.
    Filed Date: 9/10/13.
    Accession Number: 20130910-5055.
    Comments Due: 5 p.m. ET 9/23/13.

    Docket Numbers: RP13-1321-000.
    Applicants: Mississippi Hub, LLC.
    Description: Annual Penalty Disbursement Report of Mississippi Hub,
LLC.
    Filed Date: 9/10/13.
    Accession Number: 20130910-5111.
    Comments Due: 5 p.m. ET 9/23/13.

    Docket Numbers: RP13-1322-000.
    Applicants: Kinetica Energy Express, LLC.
    Description: Kinetica Energy Express, LLC submits tariff filing per
154.203: Kinetica Energy Express LLC--FERC Gas Tariff--Volume 1 A
Baseline Filing to be effective 9/1/2013.
    Filed Date: 9/10/13.
    Accession Number: 20130910-5160.
    Comments Due: 5 p.m. ET 9/23/13.

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

    Dated: September 11, 2013.
Nathaniel J. Davis, Sr.,
Deputy Secretary.
[FR Doc. 2013-22654 Filed 9-17-13; 8:45 am]
BILLING CODE 6717-01-P


[Federal Register Volume 76, Number 112 (Friday, June 10, 2011)]
[Notices]
[Pages 34079-34080]
[FR Doc No: 2011-14418]

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

DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2011-N-0405]

Agency Information Collection Activities; Proposed Collection;
Comment Request; Regulations for In Vivo Radiopharmaceuticals Used for
Diagnosis and Monitoring

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice.

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

SUMMARY: The Food and Drug Administration (FDA) is announcing an
opportunity for public comment on the proposed collection of certain
information by the Agency. Under the Paperwork Reduction Act of 1995
(the PRA), Federal agencies are required to publish notice in the
Federal Register concerning each proposed collection of information,
including each proposed extension of an existing collection of
information, and to allow 60 days for public comment in response to the
notice. This notice solicits comments on information collection for in
vivo Radiopharmaceuticals Used for Diagnosis and Monitoring.

DATES: Submit either electronic or written comments on the collection
of information by August 9, 2011.

ADDRESSES: Submit electronic comments on the collection of information
to http://www.regulations.gov. Submit written comments on the
collection of information to the Division of Dockets Management (HFA-
305), Food and Drug Administration, 5630 Fishers Lane, Rm. 1061,
Rockville, MD 20852. All comments should be identified with the docket
number found in brackets in the heading of this document.

FOR FURTHER INFORMATION CONTACT: Elizabeth Berbakos, Office of
Information Management, Food and Drug Administration, 1350 Piccard Dr.,
PI50-400B, Rockville, MD 20850,<PHONE_NUMBER>,
<EMAIL_ADDRESS>
SUPPLEMENTARY INFORMATION: Under the PRA (44 U.S.C. 3501-3520), Federal
agencies must obtain approval from the Office of Management and Budget
(OMB) for each collection of information they conduct or sponsor.
``Collection of information'' is defined in 44 U.S.C. 3502(3) and 5 CFR
1320.3(c) and includes Agency requests or requirements that members of
the public submit reports, keep records, or provide information to a
third party. Section 3506(c)(2)(A) of the PRA (44 U.S.C. 3506(c)(2)(A))
requires Federal agencies to provide a 60-day notice in the Federal
Register concerning each proposed collection of information, including
each proposed extension of an existing collection of information,
before submitting the collection to OMB for approval. To comply with
this requirement, FDA is publishing notice of the proposed collection
of information set forth in this document.
    With respect to the following collection of information, FDA
invites comments on these topics: (1) Whether the proposed collection
of information is necessary for the proper performance of FDA's
functions, including whether the information will have practical
utility; (2) the accuracy of FDA's estimate of the burden of the
proposed collection of information, including the validity of the
methodology and assumptions used; (3) ways to enhance the quality,
utility, and clarity of the information to be collected; and (4) ways
to minimize the burden of the collection of information on respondents,
including through the use of automated collection techniques, when
appropriate, and other forms of information technology.

Regulations for In Vivo Radiopharmaceuticals Used for Diagnosis and
Monitoring--21 CFR Part 315 (OMB Control Number 0910-0409)--Extension

    FDA is requesting OMB approval of the information collection
requirements contained in 21 CFR 315.4, 315.5, and 315.6. These
regulations require manufacturers of diagnostic radiopharmaceuticals to
submit information that demonstrates the safety and effectiveness of a
new diagnostic radiopharmaceutical or of a new indication for use of an
approved diagnostic radiopharmaceutical.
    In response to the requirements of section 122 of the Food and Drug
Administration Modernization Act of 1997 (Pub. L. 105-115), FDA
published a final rule in the Federal Register of May 17, 1999 (64 FR
26657), amending its regulations by adding provisions that clarify the
Agency's evaluation and approval of in vivo radiopharmaceuticals used
in the diagnosis or monitoring of diseases. The regulation describes
the kinds of indications of diagnostic radiopharmaceuticals and some of
the criteria that the Agency would use to evaluate the safety and
effectiveness of a diagnostic radiopharmaceutical under section 505 of
the Federal Food, Drug, and Cosmetic Act (the FD&C Act) (21 U.S.C. 355)
and section 351 of the Public Health Service Act (the PHS Act) (42
U.S.C. 262). Information about the safety or effectiveness of a
diagnostic radiopharmaceutical enables FDA to properly evaluate the
safety and effectiveness profiles of a new diagnostic
radiopharmaceutical or a new indication for use of an approved
diagnostic radiopharmaceutical.
    The rule clarifies existing FDA requirements for approval and
evaluation of drug and biological products already in place under the
authorities of the FD&C Act and the PHS Act. The information, which is
usually submitted as part of a new drug application or biologics
license application or as a supplement to an approved application,
typically includes, but is not limited to, nonclinical and clinical
data on the pharmacology, toxicology, adverse events, radiation safety
assessments, and chemistry, manufacturing, and controls. The content
and format of an application for approval of a new drug are set forth
in Sec.  314.50 (21 CFR 314.50). Under 21 CFR part 315, information
required under the FD&C Act and needed by FDA to evaluate the safety
and effectiveness of in vivo radiopharmaceuticals still needs to be
reported.
    Based on the number of submissions (that is, human drug
applications and/or new indication supplements for diagnostic
radiopharmaceuticals) that FDA receives, the Agency estimates that it
will receive approximately two submissions annually from two
applicants. The hours per response refers to the estimated number of
hours that an applicant would spend preparing the information required
by the regulations. Based on FDA's experience, the Agency estimates the
time needed to prepare a complete application for a diagnostic
radiopharmaceutical to be approximately 10,000 hours, roughly one-
fifth, or 2,000 hours, of which is estimated to be spent preparing the
portions of the application that would be affected by these
regulations. The regulation does not impose any additional reporting
burden for safety and effectiveness information on diagnostic
radiopharmaceuticals beyond the estimated burden of 2,000 hours

because safety and effectiveness information is already required by
Sec.  314.50 (collection of information approved by OMB under OMB
control number 0910-0001). In fact, clarification in these regulations
of FDA's standards for evaluation of diagnostic radiopharmaceuticals is
intended to streamline overall information collection burdens,
particularly for diagnostic radiopharmaceuticals that may have well-
established, low-risk safety profiles, by enabling manufacturers to
tailor information submissions and avoid unnecessary clinical studies.
Table 1 of this document contains estimates of the annual reporting
burden for the preparation of the safety and effectiveness sections of
an application that are imposed by existing regulations. This estimate
does not include the actual time needed to conduct studies and trials
or other research from which the reported information is obtained.

                                                     Table 1--Estimated Annual Reporting Burden \1\
--------------------------------------------------------------------------------------------------------------------------------------------------------
                                                                                Number of                          Average  burden
                      21 CFR Section                           Number of        responses per       Total annual      per  response       Total hours
                                                              respondents         respondent         responses          (in hours)
--------------------------------------------------------------------------------------------------------------------------------------------------------
315.4, 315.5, and 315.6..................................                 2                  1                  2              2,000              4,000
--------------------------------------------------------------------------------------------------------------------------------------------------------
\1\ There are no capital costs or operating and maintenance costs associated with this collection of information.

    Dated: June 6, 2011.
Leslie Kux,
Acting Assistant Commissioner for Policy.
[FR Doc. 2011-14418 Filed 6-9-11; 8:45 am]
BILLING CODE 4160-01-P


[Federal Register Volume 82, Number 222 (Monday, November 20, 2017)]
[Rules and Regulations]
[Page 55052]
[FR Doc No: 2017-25022]

=======================================================================
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ENVIRONMENTAL PROTECTION AGENCY

40 CFR Part 52

[EPA-R03-OAR-2013-0408; FRL-9970-83-Region 3]

Air Plan Approval; Delaware; State Implementation Plan for
Interstate Transport for the 2008 Ozone Standard; Withdrawal of Direct
Final Rule

AGENCY: Environmental Protection Agency (EPA).

ACTION: Withdrawal of direct final rule.

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

SUMMARY: Due to adverse comments received, the Environmental Protection
Agency (EPA) is withdrawing the September 27, 2017 direct final rule
that approved a revision to the Delaware state implementation plan
(SIP) related to the interstate transport of air pollution for the 2008
ozone national ambient air quality standards (NAAQS). EPA stated in the
direct final rule that if EPA received adverse comments by October 27,
2017, the rule would be withdrawn and not take effect. EPA subsequently
received adverse comments. EPA will address the comments received in a
subsequent final rulemaking action based upon the proposed approval
action for the same SIP submittal which was also published on September
27, 2017. EPA will not institute a second comment period on this
action.

DATES: The direct final rule published at 82 FR 44932 on September 27,
2017 is withdrawn effective November 20, 2017.

FOR FURTHER INFORMATION CONTACT: Ellen Schmitt,<PHONE_NUMBER> or at
[email protected].

SUPPLEMENTARY INFORMATION: The SIP revision was formally submitted by
the State of Delaware, through the Delaware Department of Natural
Resources and Environmental Control (DNREC), on March 27, 2013. The
March 2013 SIP revision was submitted in order to satisfy the
requirements of section 110(a)(2) of the Clean Air Act (CAA) for the
2008 ozone NAAQS. The September 27, 2017 direct final rule action
addressed one portion of the March 2013 submittal, finding that
Delaware has fully satisfied prongs 1 and 2 of section
110(a)(2)(D)(i)(I) of the CAA for the 2008 ozone NAAQS. EPA had
previously acted on other portions of Delaware's March 27, 2013 SIP
submittal.
    In the direct final rule published on September 27, 2017 (82 FR
44932), EPA stated that if the Agency received adverse comment by
October 27, 2017, the rule would be withdrawn and not take effect. EPA
subsequently received adverse comments from anonymous commenters. As a
result of the comments received, EPA is withdrawing the direct final
rule approving the revision to the Delaware SIP to reflect the
interstate transport of air pollution for the 2008 ozone NAAQS. EPA
will respond to the adverse comments in a subsequent final rulemaking
action.

List of Subjects in 40 CFR Part 52

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

    Dated: November 3, 2017.
Cosmo Servidio,
Regional Administrator, Region III.

0
Accordingly, the amendments to 40 CFR 52.420(e) published on September
27, 2017 (82 FR 44932), are withdrawn effective November 20, 2017.

[FR Doc. 2017-25022 Filed 11-17-17; 8:45 am]
 BILLING CODE 6560-50-P


[Federal Register Volume 85, Number 201 (Friday, October 16, 2020)]
[Notices]
[Page 65891]
[FR Doc No: 2020-23085]

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

SECURITIES AND EXCHANGE COMMISSION

Sunshine Act Meetings

TIME AND DATE: 2:00 p.m. on Wednesday, October 21, 2020.

PLACE: The meeting will be held via remote means and/or at the
Commission's headquarters, 100 F Street NE, Washington, DC 20549.

STATUS: This meeting will be closed to the public.

MATTERS TO BE CONSIDERED: Commissioners, Counsel to the Commissioners,
the Secretary to the Commission, and recording secretaries will attend
the closed meeting. Certain staff members who have an interest in the
matters also may be present.
    In the event that the time, date, or location of this meeting
changes, an announcement of the change, along with the new time, date,
and/or place of the meeting will be posted on the Commission's website
at https://www.sec.gov.
    The General Counsel of the Commission, or his designee, has
certified that, in his opinion, one or more of the exemptions set forth
in 5 U.S.C. 552b(c)(3), (5), (6), (7), (8), 9(B) and (10) and 17 CFR
200.402(a)(3), (a)(5), (a)(6), (a)(7), (a)(8), (a)(9)(ii) and (a)(10),
permit consideration of the scheduled matters at the closed meeting.
    The subject matter of the closed meeting will consist of the
following topic:

Institution and settlement of injunctive actions;
Institution and settlement of administrative proceedings;
Resolution of litigation claims; and
Other matters relating to enforcement proceedings.

    At times, changes in Commission priorities require alterations in
the scheduling of meeting agenda items that may consist of
adjudicatory, examination, litigation, or regulatory matters.

CONTACT PERSON FOR MORE INFORMATION: For further information; please
contact Vanessa A. Countryman from the Office of the Secretary at (202)
551-5400.

    Dated: October 14, 2020.
Vanessa A. Countryman,
Secretary.
[FR Doc. 2020-23085 Filed 10-14-20; 4:15 pm]
BILLING CODE 8011-01-P


[Federal Register Volume 82, Number 196 (Thursday, October 12, 2017)]
[Notices]
[Pages 47554-47555]
[FR Doc No: 2017-22029]

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DEPARTMENT OF HOMELAND SECURITY

Federal Emergency Management Agency

[Docket ID FEMA-2017-0002; Internal Agency Docket No. FEMA-B-1747]

Proposed Flood Hazard Determinations

AGENCY: Federal Emergency Management Agency, DHS.

ACTION: Notice.

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SUMMARY: Comments are requested on proposed flood hazard
determinations, which may include additions or modifications of any
Base Flood Elevation (BFE), base flood depth, Special Flood Hazard Area
(SFHA) boundary or zone designation, or regulatory floodway on the
Flood Insurance Rate Maps (FIRMs), and where applicable, in the
supporting Flood Insurance Study (FIS) reports for the communities
listed in the table below. The purpose of this notice is to seek
general information and comment regarding the preliminary FIRM, and
where applicable, the FIS report that the Federal Emergency Management
Agency (FEMA) has provided to the affected communities. The FIRM and
FIS report are the basis of the floodplain management measures that the
community is required either to adopt or to show evidence of having in
effect in order to qualify or remain qualified for participation in the
National Flood Insurance Program (NFIP). In addition, the FIRM and FIS
report, once effective, will be used by insurance agents and others to
calculate appropriate flood insurance premium rates for new buildings
and the contents of those buildings.

DATES: Comments are to be submitted on or before January 10, 2018.

ADDRESSES: The Preliminary FIRM, and where applicable, the FIS report
for each community are available for inspection at both the online
location and the respective Community Map Repository address listed in
the tables below. Additionally, the current effective FIRM and FIS
report for each community are accessible online through the FEMA Map
Service Center at www.msc.fema.gov for comparison.
    You may submit comments, identified by Docket No. FEMA-B-1747, to
Rick Sacbibit, Chief, Engineering Services Branch, Federal Insurance
and Mitigation Administration, FEMA, 400 C Street SW., Washington, DC
20472,<PHONE_NUMBER>, or (email<EMAIL_ADDRESS>
FOR FURTHER INFORMATION CONTACT: Rick Sacbibit, Chief, Engineering
Services Branch, Federal Insurance and Mitigation Administration, FEMA,
400 C Street SW., Washington, DC 20472,<PHONE_NUMBER>, or (email)
<EMAIL_ADDRESS>or visit the FEMA Map Information
eXchange (FMIX) online at www.floodmaps.fema.gov/fhm/fmx_main.html.

SUPPLEMENTARY INFORMATION: FEMA proposes to make flood hazard
determinations for each community listed below, in accordance with
section 110 of the Flood Disaster Protection Act of 1973, 42 U.S.C.
4104, and 44 CFR 67.4(a).
    These proposed flood hazard determinations, together with the
floodplain management criteria required by 44 CFR 60.3, are the minimum
that are required. They should not be construed to mean that the
community must change any existing ordinances that are more stringent
in their floodplain management requirements. The community may at any
time enact stricter requirements of its own or pursuant to policies
established by other Federal, State, or regional entities. These flood
hazard determinations are used to meet the floodplain management
requirements of the NFIP and also are used to calculate the appropriate
flood insurance premium rates for new buildings built after the FIRM
and FIS report become effective.
    The communities affected by the flood hazard determinations are
provided in the tables below. Any request for reconsideration of the
revised flood hazard information shown on the Preliminary FIRM and FIS
report that satisfies the data requirements outlined in 44 CFR 67.6(b)
is considered an appeal. Comments unrelated to the flood hazard
determinations also will be considered before the FIRM and FIS report
become effective.
    Use of a Scientific Resolution Panel (SRP) is available to
communities in support of the appeal resolution process. SRPs are
independent panels of experts in hydrology, hydraulics, and other
pertinent sciences established to review conflicting scientific and
technical data and provide recommendations for resolution. Use of the
SRP only may be exercised after FEMA and local communities have been
engaged in a collaborative consultation process for at least 60 days
without a mutually acceptable resolution of an appeal. Additional
information regarding the SRP process can be found online at http://floodsrp.org/pdfs/srp_fact_sheet.pdf.

    The watersheds and/or communities affected are listed in the tables
below. The Preliminary FIRM, and where applicable, FIS report for each
community are available for inspection at both the online location and
the respective Community Map Repository address listed in the tables.
For communities with multiple ongoing Preliminary studies, the studies
can be identified by the unique project number and Preliminary FIRM
date listed in the tables. Additionally, the current effective FIRM and
FIS report for each community are accessible online through the FEMA
Map Service Center at www.msc.fema.gov for comparison.

(Catalog of Federal Domestic Assistance No. 97.022, ``Flood
Insurance.'')

    Dated: September 16, 2017.
Roy E. Wright,
Deputy Associate Administrator for Insurance and Mitigation, Department
of Homeland Security, Federal Emergency Management Agency.
    I. Non-watershed-based studies:

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                                             Community map repository
               Community                             address
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                   Valdez-Cordova Census Area, Alaska
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      Maps Available for Inspection Online at: http://www.fema.gov/preliminaryfloodhazarddata preliminaryfloodhazarddata
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 Project: 11-10-0414S Preliminary Dates: September 15, 2016, February 1,
                        2017, and April 10, 2017
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City of Valdez.........................  City Hall, 212 Chenega Avenue,
                                          Valdez, AK 99686.
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            Whatcom County, Washington and Incorporated Areas
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      Maps Available for Inspection Online at: http://www.fema.gov/preliminaryfloodhazarddata preliminaryfloodhazarddata
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 Project: 13-10-0343S Preliminary Dates: September 30, 2015 and June 9,
                                  2017
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Unincorporated Areas of Whatcom County.  Public Works/River and Flood
                                          Division, 322 North Commercial
                                          Street, Suite 120, Bellingham,
                                          WA 98225.
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[FR Doc. 2017-22029 Filed 10-11-17; 8:45 am]
 BILLING CODE 9110-12-P