[Federal Register Volume 81, Number 47 (Thursday, March 10, 2016)]
[Notices]
[Page 12726]
[FR Doc No: 2016-05351]

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DEPARTMENT OF ENERGY

Federal Energy Regulatory Commission

[Docket No. AD16-16-000]

Implementation Issues Under the Public Utility Regulatory
Policies Act of 1978; Supplemental Notice Concerning Technical
Conference

    As announced in the Notice of Technical Conference issued on
February 9, 2016, the Federal Energy Regulatory Commission (Commission)
will hold a technical conference on June 29, 2016, from 9:00 a.m. to
approximately 4:00 p.m. on implementation issues under the Public
Utility Regulatory Policies Act of 1978 (PURPA).\1\ The conference will
be held in the Commission Meeting Room at the Federal Energy Regulatory
Commission, 888 First Street NE., Washington, DC 20426.
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    \1\ 16 U.S.C. 824a-3 (2012).
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    The purpose of the technical conference is to focus on issues
associated with the Commission's implementation of PURPA. As provided
in the attached preliminary agenda, the conference will focus on two
issues: The mandatory purchase obligation under PURPA and the
determination of avoided costs for those purchases.
    Those interested in speaking at the technical conference should
notify the Commission by April 4, 2016, by completing the online form
at the following Web page: https://www.ferc.gov/whats-new/registration/06-29-16-speaker-form.asp. At this Web page, please provide an abstract
(700 character limit) of the issue(s) you propose to address. Due to
time constraints, we expect to not be able to accommodate all those
interested in speaking. Selected speakers will be notified as soon as
possible.
    Those who plan to attend the technical conference are strongly
encouraged to complete the registration form located at: https://www.ferc.gov/whats-new/registration/06-29-16-form.asp. There is no
registration deadline or fee to attend the conference.
    Information on this event will be posted on the Calendar of Events
on the Commission's Web site, http://www.ferc.gov, prior to the event.
The conference will be transcribed. Transcripts will be available for a
fee from Ace Reporting Company<PHONE_NUMBER>). A free webcast of this
event is also available through www.ferc.gov. Anyone with Internet
access who desires to view this event can do so by navigating to http://www.ferc.gov Calendar of Events and locating this event in the
Calendar. The event will contain a link to the webcast. The Capitol
Connection provides technical support for webcasts and offers the
option of listening to the meeting via phone-bridge for a fee. If you
have any questions, visit www.CapitolConnection.org or call 703-993-
3100.
    Commission conferences are accessible under section 508 of the
Rehabilitation Act of 1973. For accessibility accommodations, please
send an email to<EMAIL_ADDRESS>or call toll free (866) 208-
3372 (voice) or<PHONE_NUMBER> (TTY), or send a FAX to<PHONE_NUMBER>
with the required accommodations.
    For more information about the technical conferences, please
contact:

Technical Information

    Adam Alvarez, Office of Energy Market Regulation, Federal Energy
Regulatory Commission, 888 First Street NE., Washington, DC 20426,
(202) 502-6734<EMAIL_ADDRESS>
Legal Information

    Loni Silva, Office of the General Counsel, Federal Energy
Regulatory Commission, 888 First Street NE., Washington, DC 20426,
(202) 502-6233<EMAIL_ADDRESS>
Logistical Information

    Sarah McKinley, Office of External Affairs, Federal Energy
Regulatory Commission, 888 First Street NE., Washington, DC 20426,
(202) 502-8368<EMAIL_ADDRESS>
    Dated: March 4, 2016.
Nathaniel J. Davis, Sr.,
Deputy Secretary.
[FR Doc. 2016-05351 Filed 3-9-16; 8:45 am]
BILLING CODE 6717-01-P


[Federal Register Volume 81, Number 100 (Tuesday, May 24, 2016)]
[Proposed Rules]
[Pages 32702-32707]
[FR Doc No: 2016-12113]

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ENVIRONMENTAL PROTECTION AGENCY

40 CFR Part 52

[EPA-R04-OAR-2015-0361; FRL-9946-81-Region 4]

Air Plan Approval; Florida; Regional Haze Progress Report

AGENCY: Environmental Protection Agency (EPA).

ACTION: Proposed rule.

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SUMMARY: The Environmental Protection Agency (EPA) is proposing to
approve a State Implementation Plan (SIP) revision submitted by the
State of Florida through the Florida Department of Environmental
Protection (FDEP) on March 10, 2015. Florida's March 10, 2015, SIP
revision (Progress Report) addresses requirements of the Clean Air Act
(CAA or Act) and EPA's rules that require states to submit periodic
reports describing progress towards reasonable progress goals (RPGs)
established for regional haze and a determination of the adequacy of a
state's existing SIP addressing regional haze (regional haze plan). EPA
is proposing to approve Florida's Progress Report on the basis that it
addresses the progress report and adequacy determination requirements
for the first implementation period for regional haze.

DATES: Comments must be received on or before June 23, 2016.

ADDRESSES: Submit your comments, identified by Docket ID No. EPA-R04-
OAR-2015-0361 at http://www.regulations.gov. Follow the online
instructions for submitting comments. Once submitted, comments cannot
be edited or removed from Regulations.gov. EPA may publish any comment
received to its public docket. Do not submit electronically any
information you consider to be Confidential Business Information (CBI)
or other information whose disclosure is restricted by statute.
Multimedia submissions (audio, video, etc.) must be accompanied by a
written comment. The written comment is considered the official comment
and should include discussion of all points you wish to make. EPA will
generally not consider comments or comment contents located outside of
the primary submission (i.e. on the web, cloud, or other file sharing
system). For additional submission methods, the full EPA public comment
policy, information about CBI or multimedia submissions, and general
guidance on making effective comments, please visit http://www2.epa.gov/dockets/commenting-epa-dockets.

FOR FURTHER INFORMATION CONTACT: Sean Lakeman, Air Regulatory
Management Section, Air Planning and Implementation Branch, Air,
Pesticides and Toxics Management Division, U.S. Environmental
Protection Agency, Region 4, 61 Forsyth Street, SW., Atlanta, Georgia
30303-8960. Mr. Lakeman can be reached by phone at<PHONE_NUMBER> and
via electronic mail at<EMAIL_ADDRESS>
SUPPLEMENTARY INFORMATION:

I. Background

    Under the Regional Haze Rule,\1\ each state is required to submit a
progress report in the form of a SIP revision every five years that
evaluates progress towards the RPGs for each mandatory Class I Federal
area (also referred to as Class I area in this rulemaking) within the
state and for each mandatory Class I Federal area outside the state
which may be affected by emissions from within the state. See 40 CFR
51.308(g). Each state is also required to submit, at the same time as
the progress report, a determination of the adequacy of the state's
existing regional haze plan. See 40 CFR 51.308(h). The first progress
report is due five years after submittal of the initial regional haze
plan. On March 19, 2010, FDEP submitted the State's first regional haze
plan in accordance with 40 CFR 51.308(b).\2\
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    \1\ 40 CFR part 51, subpart P.
    \2\ On August 29, 2013, EPA fully approved Florida's regional
haze plan (as amended on August 31, 2010, and September 17, 2012).
See 78 FR 53250.
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    On March 10, 2015, FDEP submitted its regional haze progress
report, reporting progress made in the first implementation period
towards RPGs for Class I areas in the State and for Class I areas
outside the State that are

affected by emissions from sources within Florida. This submittal also
includes a negative declaration pursuant to 40 CFR 51.308(h)(1) that
the State's regional haze plan requires no substantive revision to
achieve the established regional haze visibility improvement goals for
2018. EPA is proposing to approve Florida's progress report on the
basis that it satisfies the requirements of 40 CFR 51.308(g) and
51.308(h).

II. What are the requirements for the regional haze progress report and
adequacy determinations?

A. Regional Haze Progress Report

    Under 40 CFR 51.308(g), states must submit a regional haze progress
report as a SIP revision every five years and must address, at a
minimum, the seven elements found in 40 CFR 51.308(g). As described in
further detail in section III below, 40 CFR 51.308(g) requires: (1) A
description of the status of measures in the approved regional haze
plan; (2) a summary of emissions reductions achieved; (3) an assessment
of visibility conditions for each Class I area in the state; (4) an
analysis of changes in emissions from sources and activities within the
state; (5) an assessment of any significant changes in anthropogenic
emissions within or outside the state that have limited or impeded
progress in Class I areas impacted by the state's sources; (6) an
assessment of the sufficiency of the approved regional haze plan; and
(7) a review of the state's visibility monitoring strategy.

B. Adequacy Determinations of the Current Regional Haze Plan

    Under 40 CFR 51.308(h), states are required to submit, at the same
time as the progress report, a determination of the adequacy of their
existing regional haze plan and to take one of four possible actions
based on information in the progress report. As described in further
detail in section III below, 40 CFR 51.308(h) requires states to: (1)
Submit a negative declaration to EPA that no further substantive
revision to the state's existing regional haze plan is needed; (2)
provide notification to EPA (and to other state(s) that participated in
the regional planning process) if the state determines that its
existing regional haze plan is or may be inadequate to ensure
reasonable progress at one or more Class I areas due to emissions from
sources in other state(s) that participated in the regional planning
process, and collaborate with these other state(s) to develop
additional strategies to address deficiencies; (3) provide notification
with supporting information to EPA if the state determines that its
existing regional haze plan is or may be inadequate to ensure
reasonable progress at one or more Class I areas due to emissions from
sources in another country; or (4) revise its regional haze plan to
address deficiencies within one year if the state determines that its
existing regional haze plan is or may be inadequate to ensure
reasonable progress in one or more Class I areas due to emissions from
sources within the state.

III. What is EPA's analysis of Florida's regional haze progress report
and adequacy determination?

    On March 10, 2015, FDEP submitted a revision to Florida's regional
haze plan to address progress made towards the RPGs for Class I areas
in the State and for Class I areas outside the State that are affected
by emissions from sources within Florida. This submittal also includes
a determination of the adequacy of the State's existing regional haze
plan. Florida has three mandatory Class I areas within its borders:
Everglades National Park, Chassahowitzka Wilderness Area, and St. Marks
Wilderness Area. In Florida's regional haze plan, the State also
determined that emissions sources located in Florida may have
significant sulfate visibility impacts on the following Class I areas
in neighboring states: Okefenokee Wilderness Area and Wolf Island
Wilderness Area in Georgia, and Breton Wilderness Area in Louisiana.

A. Regional Haze Progress Report

    The following sections summarize: (1) Each of the seven elements
that must be addressed by a progress report under 40 CFR 51.308(g); (2)
how Florida's Progress Report addressed each element; and (3) EPA's
analysis and proposed determination as to whether the State satisfied
each element.
1. Status of Control Measures
    40 CFR 51.308(g)(1) requires a description of the status of
implementation of all measures included in the regional haze plan for
achieving RPGs for Class I areas both within and outside the state.
    The State evaluated the status of all measures included in its
regional haze plan in accordance with 40 CFR 51.308(g)(1).
Specifically, in its Progress Report, Florida summarizes the status of
the emissions reduction measures that were included in the final
iteration of the Visibility Improvement State and Tribal Association of
the Southeast (VISTAS) regional haze emissions inventory and RPG
modeling used by the State in developing its regional haze plan. These
measures include, among other things, applicable federal programs
(e.g., mobile source rules, Maximum Achievable Control Technology
(MACT) standards), federal and state consent agreements, and federal
and state control strategies for electric generating units (EGUs). The
State also addresses the status of Best Available Retrofit Technology
(BART) and reasonable progress controls included in the regional haze
plan and discusses the status of several measures that were not
included in the final VISTAS emissions inventory and were not relied
upon in the initial regional haze plan to meet RPGs. The State notes
that the emissions reductions from these recent measures will help
ensure Class I areas impacted by Florida sources achieve their RPGs. In
aggregate, as noted in sections III.A.2 and III.A.6 of this notice, the
emissions reductions from the identified measures are expected to
exceed the emissions projections in Florida's regional haze plan.
    In its regional haze plan, Florida identified sulfur dioxide
(SO2) emissions from coal-fired EGUs as a key contributor to
regional haze in the VISTAS region, with the EGU sector as a major
contributor to visibility impairment at all Class I areas in the VISTAS
region. The State's Progress Report provides additional information on
EGU control strategies and the status of existing and future expected
controls for EGUs in Florida, with updated actual SO2
emissions data for the years 2007-2013.
    EPA proposes to find that Florida's analysis adequately addresses
40 CFR 51.308(g)(1). The State documents the implementation status of
measures from its regional haze plan in addition to describing
additional measures not originally accounted for in the final VISTAS
emissions inventory that came into effect since the VISTAS analyses for
the regional haze plan were completed.
2. Emissions Reductions and Progress
    40 CFR 51.308(g)(2) requires a summary of the emissions reductions
achieved in the state through implementing measures described in 40 CFR
51.308(g)(1).
    In its Progress Report, Florida evaluated the emissions reductions
associated with the implementation of many measures identified in its
regional haze plan, including the emissions reductions associated with
sources subject to BART or reasonable progress control determinations.
As described

below, Florida included nitrogen oxides (NOX) and
SO2 emissions data for EGUs in Florida from 2002-2013 and
annual SO2 emissions data from point sources in the State
from 2000-2013. In its regional haze plan, Florida states that ammonium
sulfate is the largest contributor to visibility impairment in Class I
areas throughout the southeastern United States during the baseline
period from 2000-2004. Emissions sensitivity modeling performed by
VISTAS determined that the most effective ways to reduce ammonium
sulfate were to reduce SO2 emissions from coal-fired EGUs
and, with an important but smaller impact, to reduce SO2
emissions from non-utility industrial point sources. SO2
reductions from point sources were therefore identified as the focus of
Florida's long-term strategy for visibility improvement. In its
Progress Report, Florida examined pollutants affecting visibility in
Class I areas in Florida to ascertain whether it is still appropriate
to focus on SO2 emissions to improve visibility in Class I
areas impacted by sources in Florida. Using updated data for the 2006-
2010 time period, the State concludes that ammonium sulfate continues
to be the largest contributor to visibility impairment in these areas.
    The data from EPA's Clean Air Markets Division included in the
Progress Report for Acid Rain Program units from 2002-2013 show that
SO2 emissions from EGUs in Florida and in the VISTAS region
have declined during this time period even though heat input to these
units remains fairly steady. See Figure 4-2 in Florida's submittal.
Between 2002 and 2013, heat input to these units decreased from
approximately 1,597,000,000 (million British Thermal Units) MMBtu to
1,548,000,000 MMBtu, a decrease of three percent. SO2
emissions from these units decreased from 466,904 tons annually in 2002
to 88,004 tons annually in 2013, a decrease of 81.2 percent, and the
average SO2 emission rate from these units decreased from
0.603 pounds per MMBtu (lbs/MMBtu) in 2002 to 0.114 lbs/MMBtu in 2013,
a decrease of 81.1 percent. Over the same time period, NOX
emissions from these units decreased from 258,378 tons in 2002 to
54,398 tons in 2013, a decrease of 78.9 percent. Florida states that
the SO2 and NOX emissions reductions are due to
the installation of controls and the use of cleaner burning fuels.
Florida also identifies the shut-down of eight BART sources and three
reasonable progress sources.
    Florida's Progress Report also includes SO2 and
NOX emissions and heat input trends for Acid Rain Program
units in the VISTAS region. See Figure 4-3 in Florida's submittal.
Between 2002 and 2011, heat input to these units decreased from
7,645,295,464 MMBtu to 7,336,055,333 MMBtu, a decrease of four percent.
SO2 emissions from these units decreased from 3,713,262 tons
annually in 2002 to 1,166,572 tons annually in 2011, a decrease of 69.9
percent, and the average SO2 emission rate from these units
decreased from 0.971 lbs/MMBtu in 2002 to 0.318 lbs/MMBtu in 2011, a
decrease of 67.3 percent. Over the same time period, NOX
emissions decreased from 1,498,143 tons in 2002 to 464,129 tons in
2011, a decrease of 69 percent.
    Between 2009 and 2011, the total VISTAS states' heat input for Acid
Rain Program units increased from 6,966,765,915 MMBtu to 7,336,055,333
MMBtu. However, emissions from these units declined from 1,619,348 tons
of SO2 in 2009 to 1,166,572 tons of SO2 in 2011,
and the emission rates of SO2 decreased from 0.465 lbs/MMBtu
to 0.318 lbs/MMBtu.
    Florida believes that the reductions in SO2 and
NOX described above are a result of many factors, including
permanent changes at EGUs through the use of control technology and
fuel switching. In Florida and the VISTAS region, Florida concluded
that these emissions reductions have been achieved even though heat
input to these units remains fairly steady. Thus, the State believes
that the visibility improvements from the reductions in SO2
and NOX should continue into the future even though demand
for power and heat input to these units may have moderate increases.
    EPA proposes to conclude that Florida has adequately addressed 40
CFR 51.308(g)(2). As discussed above, the State provides emissions
reduction estimates, and where available, actual emissions reductions
of visibility-impairing pollutants resulting from the measures relied
upon in its regional haze plan. The State appropriately focused on
SO2 emissions from EGUs in its Progress Report because the
State had previously identified these emissions as the most significant
contributors to visibility impairment at Florida's Class I areas and
those Class I areas that Florida sources impact.
3. Visibility Progress
    40 CFR 51.308(g)(3) requires that states with Class I areas provide
the following information for the most impaired and least impaired days
for each area, with values expressed in terms of five-year averages of
these annual values: \3\
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    \3\ The ``most impaired days'' and ``least impaired days'' in
the Regional Haze Rule refers to the average visibility impairment
(measured in deciviews) for the twenty percent of monitored days in
a calendar year with the highest and lowest amount of visibility
impairment, respectively, averaged over a five-year period. 40 CFR
51.301.
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    (i) Current visibility conditions;
    (ii) the difference between current visibility conditions and
baseline visibility conditions; and
    (iii) the change in visibility impairment over the past five years.
    The State provides figures with the latest supporting data
available at the time of plan development that address the three
requirements of 40 CFR 51.308(g)(3) for Class I areas in Florida. Table
1, below, shows the current visibility conditions and the difference
between current visibility conditions and baseline visibility
conditions. Florida reported current conditions as the 2009-2013 five-
year period and used the 2000-2004 baseline period for its Class I
areas.\4\
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    \4\ For the first regional haze plan, ``baseline'' conditions
were represented by the 2000-2004 time period. See 64 FR 35730 (July
1, 1999).

      Table 1--Baseline Visibility, Current Visibility, and Visibility Changes in Class I Areas in Florida
----------------------------------------------------------------------------------------------------------------
                                                                     Baseline         Current         Change
                          Class I area                            average (2000-  average (2009-     (current-
                                                                       2004)           2013)         baseline)
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20% Worst Days:
    Chassahowitzka..............................................           25.75           21.33           -4.42
    Everglades..................................................           22.30           18.14           -4.16
    St. Marks...................................................           26.31           22.22           -4.09
20% Best Days:

    Chassahowitzka..............................................           15.51           13.74           -1.77
    Everglades..................................................           11.69           11.21           -0.48
    St. Marks...................................................           14.37           13.33           -1.04
----------------------------------------------------------------------------------------------------------------

    The data summarized above shows that all Class I areas in the State
saw an improvement in visibility (i.e., reduced impairment) on the 20
percent worst days and on the 20 percent best days. For the 20 percent
worst days, the current observed five-year average values for all three
areas are below the 2013 glide path values and the corresponding 2018
RPG. See Table 3-1 in Florida's submittal. For the 20 percent best
days, the current observed five-year average values for all three areas
are below baseline visibility conditions. Florida's submittal also
includes the change in visibility impairment for the 20 percent worst
and 20 percent best days from the 2001-2005 time period through the
2009-2013 time period in five-year average increments. See Table 3-2 of
Florida's submittal. The data also shows that all three Class I areas
saw an improvement in visibility on the 20 percent worst days and on
the 20 percent best days.
    EPA proposes to conclude that Florida has adequately addressed 40
CFR 51.308(g)(3) because the State provides the information regarding
visibility conditions and visibility changes necessary to meet the
requirements of the regulation. The Progress Report includes current
conditions based on the Interagency Monitoring of Protected Visual
Environments (IMPROVE) monitoring data for the years 2009-2013, the
difference between current visibility conditions and baseline
visibility conditions, and the change in visibility impairment over the
most recent five-year period for which data were available at the time
of Progress Report development (i.e., 2009-2013).
4. Emission Tracking
    40 CFR 51.308(g)(4) requires an analysis tracking emissions changes
of visibility-impairing pollutants from the state's sources by type or
category over the past five years based on the most recent updated
emissions inventory.
    In its Progress Report, Florida includes an analysis tracking the
change over a five-year period in emissions of pollutants contributing
to visibility impairment from the following source categories: point,
area, non-road mobile, and on-road mobile. The State evaluated
emissions trends in SO2, NOX, and fine
particulate matter (PM2.5) with a focus on SO2
because, as noted above, Florida concludes that ammonium sulfate
continues to be the largest contributor to visibility impairment in
Class I areas in Florida.
    In its evaluation of NOX, PM2.5, and
SO2 emissions trends, Florida used the 2002 actual and 2009
and 2018 projected inventories from its regional haze plan as well as
the Southeastern Modeling, Analysis, and Planning Project (SEMAP) 2007
actual emissions inventory, the 2011 National Emissions Inventory (NEI)
actual emissions inventory, and the State's Annual Operation Report
point source data collected each year. See Tables 4-1 through 4-3 in
Florida's submittal. For NOX emissions, there were large
decreases in point and area emissions and some increases in on-road
mobile emissions in 2007. The State asserts that the decreases in point
source NOX were due to emissions controls that were
installed and that the decrease in area source NOX is
primarily due to the removal of coal and wood combustion boilers from
the area source inventory to avoid double counting with the point
source category. Florida also believes that the increase in on-road
mobile NOX is due to the use of the MOVES2010a model, rather
than MOBILE6.2, for the 2007 inventory. If a consistent on-road model
had been used for 2002, 2007, and 2009, the SEMAP 2007 NOX
emissions would have been lower than the VISTAS 2002 actual and VISTAS
2009 projected emissions. However, NOX emissions have
continued to decline between 2002 and 2011 by over 370,000 tons.
Regarding PM2.5, the 2007 SEMAP and 2011 NEI
PM2.5 emissions are different from the VISTAS emissions due
to methodology changes to reflect up-to-date emission calculations. For
example, Florida believes that the increase in on-road mobile
PM2.5 is due to the switch in model used. Regardless,
overall PM2.5 emissions have decreased slightly between 2002
and 2011. Regarding SO2, the inventory analysis shows that
overall emissions have decreased significantly from 2002 to 2011, with
point source reductions dominating. Florida's Progress Report also
evaluates the trend from 2000 through 2013 in SO2 point
source emissions, demonstrating a decrease of over 480,000 tons during
this time period. See Figure 4-1 in Florida's submittal.
    Also, as discussed in section III.A.2. of this notice, the Progress
Report documents reductions in NOX and SO2
emissions that occurred between 2002-2013 at EGUs in Florida. The State
believes that these reductions are a result of permanent changes at
EGUs in the State through the use of control technology, fuel
switching, and the shut-down of eight BART sources and three reasonable
progress sources.
    EPA proposes to conclude that Florida has adequately addressed 40
CFR 51.308(g)(4). Florida tracked changes in emissions of visibility-
impairing pollutants from 2002-2011 for all source categories and
analyzed trends in SO2 and NOX emissions from
EGUs in the State from 2002-2013, the most current quality-assured data
available for these units at the time of progress report development.
While ideally the five-year period to be analyzed for emissions
inventory changes is the time period since the current regional haze
plan was submitted, there is an inevitable time lag in developing and
reporting complete emissions inventories once quality-assured emissions
data becomes available. Therefore, EPA believes that there is some
flexibility in the five-year time period that states can select.
5. Assessment of Changes Impeding Visibility Progress
    40 CFR 51.308(g)(5) requires an assessment of any significant
changes in anthropogenic emissions within or outside the state that
have occurred over the past five years that have limited or impeded
progress in reducing pollutant emissions and improving visibility in
Class I areas impacted by the state's sources.
    The Progress Report demonstrates that there are no significant
changes in emissions of SO2, PM, or NOX that have
impeded progress in reducing emissions and improving visibility in
Class I areas impacted by Florida sources. As

discussed above, Florida documents that sulfates continue to be the
biggest single contributor to regional haze in Class I areas in the
State and focused its analysis on addressing large SO2
emissions from point sources. In addressing the requirements of 40 CFR
51.308(g)(5), Florida references its analysis showing that
SO2 emissions from stationary point sources have decreased
significantly from 2002 to 2013 and are well below the projections for
these sources made in Florida's regional haze plan. Regarding EGUs, the
State documented significant decreases in SO2 emissions
despite the fact that power generation has remained fairly constant
during the same period. Furthermore, the Progress Report shows that the
State is on track to meeting its 2018 RPGs for Class I areas in
Florida. For these reasons, EPA proposed to conclude that Florida's
Progress Report has adequately addressed 40 CFR 51.308(g)(5).
6. Assessment of Current Strategy
    40 CFR 51.308(g)(6) requires an assessment of whether the current
regional haze plan is sufficient to enable the state, or other states,
to meet the RPGs for Class I areas affected by emissions from the
state.
    In its Progress Report, Florida states its belief that the elements
and strategies outlined in its regional haze plan are sufficient for
Class I areas impacted by emissions sources in Florida to meet their
RPGs. To support this conclusion, Florida notes the following:
Speciated data collected for the period 2006-2010 shows that sulfates
continue to be the most significant contributor to visibility
impairment, supporting SO2 reduction as the appropriate
control strategy; the SO2 controls in the State's regional
haze plan have been implemented; a 71 percent reduction in the overall
SO2 emissions inventory from 2002 through 2011 verifies that
Florida's SO2 reduction program is achieving the reductions
that were projected in the regional haze plan; current visibility
impairment values for the 20 percent worst days are lower than the 2018
RPGs and lower than the 2013 glide path values for the Class I areas in
Florida; current visibility impairment values for the 20 percent best
days are below baseline visibility conditions for all Class I areas in
Florida; and visibility data through 2010 show that the 2010 five-year
average visibility impairment on the 20 percent worst days in the three
Class I areas outside of the State impacted by emissions sources in
Florida is at or below the glide path.
    EPA proposes to conclude that Florida has adequately addressed 40
CFR 51.308(g)(6). EPA views this requirement as a qualitative
assessment that should evaluate emissions and visibility trends and
other readily available information, including expected emissions
reductions associated with measures with compliance dates that have not
yet become effective. The State referenced the improving visibility
trends and the downward emissions trends in the State, with a focus on
SO2 emissions from Florida EGUs. These trends support the
State's determination that the State's regional haze plan is sufficient
to meet RPGs for Class I areas within and outside the State impacted by
Florida sources.
7. Review of Current Monitoring Strategy
    40 CFR 51.308(g)(7) requires a review of the state's visibility
monitoring strategy and an assessment of whether any modifications to
the monitoring strategy are necessary.
    In its Progress Report, Florida summarizes the existing visibility
monitoring network in Class I areas in Florida and notes that the
Interagency Monitoring of Protected Visual Environments (IMPROVE)
monitoring network is the primary monitoring network for regional haze.
There is currently one IMPROVE site in each Florida Class I area
(SAMA1, CHAS1, and EVER1) operated by the responsible Federal Land
Manager. Florida intends to continue to rely on the IMPROVE network for
complying with regional haze monitoring requirements and on the
Visibility Information and Exchange Web System (VIEWS) to access
IMPROVE data and data analysis tools. Florida concludes that the
existing network is adequate and that no modifications to the State's
visibility monitoring strategy are necessary at this time.
    EPA proposes to conclude that Florida has adequately addressed the
sufficiency of its monitoring strategy as required by 40 CFR
51.308(g)(7). The State reaffirmed its continued reliance upon the
IMPROVE monitoring network, explained the importance of the IMPROVE
monitoring network for tracking visibility trends in Class I areas in
Florida, and determined that no changes to its visibility monitoring
strategy are necessary.

B. Determination of Adequacy of Existing Regional Haze Plan

    Under 40 CFR 51.308(h), states are required to take one of four
possible actions based on the information gathered and conclusions made
in the progress report. The following section summarizes: (1) The
action taken by Florida under 40 CFR 51.308(h); (2) Florida's rationale
for the selected action; and (3) EPA's analysis and proposed
determination regarding the State's action.
    In its Progress Report, Florida took the action provided for by 40
CFR 51.308(h)(1), which allows a state to submit a negative declaration
to EPA if the state determines that the existing regional haze plan
requires no further substantive revision at this time to achieve the
RPGs for Class I areas affected by the state's sources. The State's
negative declaration is based on its findings in the Progress Report.
EPA proposes to conclude that Florida has adequately addressed 40 CFR
51.308(h) because the visibility trends at the Class I areas impacted
by the State's sources and the emissions trends of the State's largest
emitters of visibility-impairing pollutants indicate that the RPGs for
Class I areas impacted by sources in Florida will be met or exceeded.

IV. What action is EPA proposing to take?

    EPA is proposing to approve Florida's Regional Haze Progress
Report, SIP revision, submitted by the State on March 10, 2015, as
meeting the applicable regional haze requirements set forth in 40 CFR
51.308(g) and 51.308(h).

V. Statutory and Executive Order Reviews

    Under the CAA, the Administrator is required to approve a SIP
submission that complies with the provisions of the Act and applicable
federal regulations. See 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
proposed action merely proposes to approve state law as meeting federal
requirements and does not impose additional requirements beyond those
imposed by state law. For that reason, this proposed action:
     Is not a significant regulatory action subject to review
by the Office of Management and Budget under Executive Orders 12866 (58
FR 51735, October 4, 1993) and 13563 (76 FR 3821, January 21, 2011);
     does not impose an information collection burden under the
provisions of the Paperwork Reduction Act (44 U.S.C. 3501 et seq.);
     is certified as not having a significant economic impact
on a substantial number of small entities under the Regulatory
Flexibility Act (5 U.S.C. 601 et seq.);

     does not contain any unfunded mandate or significantly or
uniquely affect small governments, as described in the Unfunded
Mandates Reform Act of 1995 (Pub. L. 104-4);
     does not have Federalism implications as specified in
Executive Order 13132 (64 FR 43255, August 10, 1999);
     is not an economically significant regulatory action based
on health or safety risks subject to Executive Order 13045 (62 FR
19885, April 23, 1997);
     is not a significant regulatory action subject to
Executive Order 13211 (66 FR 28355, May 22, 2001);
     is not subject to requirements of Section 12(d) of the
National Technology Transfer and Advancement Act of 1995 (15 U.S.C. 272
note) because application of those requirements would be inconsistent
with the CAA; and
     does not provide EPA with the discretionary authority to
address, as appropriate, disproportionate human health or environmental
effects, using practicable and legally permissible methods, under
Executive Order 12898 (59 FR 7629, February 16, 1994).
    The SIP is not approved to apply on any Indian reservation land or
in any other area where EPA or an Indian tribe has demonstrated that a
tribe has jurisdiction. In those areas of Indian country, the rule does
not have tribal implications as specified by Executive Order 13175 (65
FR 67249, November 9, 2000), nor will it impose substantial direct
costs on tribal governments or preempt tribal law.

List of Subjects in 40 CFR Part 52

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

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

    Dated: May 12, 2016.
Heather McTeer Toney,
Regional Administrator, Region 4.
[FR Doc. 2016-12113 Filed 5-23-16; 8:45 am]
 BILLING CODE 6560-50-P


[Federal Register: September 3, 2009 (Volume 74, Number 170)]
[Rules and Regulations]
[Page 45554-45555]
[DOCID:fr03se09-6]

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

DEPARTMENT OF TRANSPORTATION

Federal Aviation Administration

14 CFR Part 71

[Docket No. FAA-2009-0196; Airspace Docket No. 09-AAL-3]

Establishment of Class E Airspace; Oooguruk, AK

AGENCY: Federal Aviation Administration (FAA), DOT.

ACTION: Final Rule.

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

SUMMARY: This action establishes Class E airspace at Oooguruk, AK,
providing controlled airspace to contain aircraft executing special
Instrument Approach Procedures (IAPs) at two heliport facilities,
Oooguruk Drill Site Helipad, and Oooguruk Tie-in Helipad, Oooguruk, AK.
Also, this action makes a minor change in the description for the
Oooguruk Drill Site Helipad. The FAA is taking this action to enhance
the safety and management of Instrument Flight Rules (IFR) operations
at Oooguruk, AK.

DATES: Effective Date: 0901 UTC, October 22, 2009. The Director of the
Federal Register approves this incorporation by reference action under
title 1, Code of Federal Regulations, part 51, subject to the annual
revision of FAA Order 7400.9 and publication of conforming amendments.

FOR FURTHER INFORMATION CONTACT: Gary Rolf, AAL-538G, Federal Aviation
Administration, 222 West 7th Avenue, Box 14, Anchorage, AK 99513-7587;
telephone number<PHONE_NUMBER>; fax:<PHONE_NUMBER>; e-mail:
<EMAIL_ADDRESS>Internet address: http://www.faa.gov/about/
office_org/headquarters_offices/ato/service_units/systemops/fs/
alaskan/rulemaking/.

SUPPLEMENTARY INFORMATION:

History

    On Wednesday April 15, 2009, the FAA proposed to amend Title 14
Code

of Federal Regulations (14 CFR) part 71, to establish Class E airspace
upward from 700 ft. above the surface and from 1,200 ft. above the
surface at two heliport facilities at Oooguruk, AK (74 FR 17443).
Subsequent to publication, the FAA found that a sentence referencing
exclusion of restricted airspace in the description for the Oooguruk
Drill Site Helipad was inadvertantly omitted. This action corrects this
error. Class E controlled airspace extending upward from 700 ft. and
1,200 ft. above the surface in the Oooguruk heliport area is
established by this action.
    Interested parties were invited to participate in this rulemaking
proceeding by submitting written comments on the proposal to the FAA.
No comments were received. The rule, with the clarification of the
airspace description of the Drill Site Helipad, is adopted as proposed.
    The Class E airspace areas designated as 700/1,200 ft. transition
areas are published in paragraph 6005 of FAA Order 7400.9S, Airspace
Designations and Reporting Points, signed October 3, 2008, and
effective October 31, 2008, which is incorporated by reference in 14
CFR 71.1. The Class E airspace designations listed in this document
will be published subsequently in the Order.

The Rule

    This amendment to 14 CFR part 71 establishes Class E airspace
extending 700 and 1,200 feet above the surface at Oooguruk, AK. New
special IAPs have been developed for two heliport facilities, Oooguruk
Drill Site Helipad, and Oooguruk Tie-in Helipad, that will provide
adequate controlled airspace for IFR operations at these landing sites.
Also, added to the airspace description for the Drill Site Helipad will
be ``* * *, excluding of that portion within R-2204 when R-2204 is
active.''
    The FAA has determined that this regulation only involves an
established body of technical regulations for which frequent and
routine amendments are necessary to keep them operationally current.
It, therefore--(1) is not a ``significant regulatory action'' under
Executive Order 12866; (2) is not a ``significant rule'' under DOT
Regulatory Policies and Procedures (44 FR 11034; February 26, 1979);
and (3) does not warrant preparation of a regulatory evaluation as the
anticipated impact is so minimal. Since this is a routine matter that
will only affect air traffic procedures and air navigation, it is
certified that this rule will not have a significant economic impact on
a substantial number of small entities under the criteria of the
Regulatory Flexibility Act.
    The FAA's authority to issue rules regarding aviation safety is
found in Title 49 of the United States Code. Subtitle 1, Section 106
describes the authority of the FAA Administrator. Subtitle VII,
Aviation Programs, describes in more detail the scope of the agency's
authority.
    This rulemaking is promulgated under the authority described in
Subtitle VII, Part A, Subpart 1, Section 40103, Sovereignty and use of
airspace. Under that section, the FAA is charged with prescribing
regulations to ensure the safe and efficient use of the navigable
airspace. This regulation is within the scope of that authority because
it creates Class E airspace sufficient in size to contain aircraft
executing instrument procedures for the two helipads at Oooguruk, AK
and represents the FAA's continuing effort to safely and efficiently
use the navigable airspace.

List of Subjects in 14 CFR Part 71

    Airspace, Incorporation by reference, Navigation (air).

Adoption of the Amendment

0
In consideration of the foregoing, the Federal Aviation Administration
amends 14 CFR part 71 as follows:

PART 71--DESIGNATION OF CLASS A, CLASS B, CLASS C, CLASS D, AND
CLASS E AIRSPACE AREAS; AIRWAYS; ROUTES; AND REPORTING POINTS

0
1. The authority citation for 14 CFR part 71 continues to read as
follows:

    Authority:  49 U.S.C. 106(g), 40103, 40113, 40120; E.O. 10854,
24 FR 9565, 3 CFR, 1959-1963 Comp., p. 389.

Sec.  71.1  [Amended]

0
2. The incorporation by reference in 14 CFR 71.1 of Federal Aviation
Administration Order 7400.9S, Airspace Designations and Reporting
Points, signed October 3, 2008, and effective October 31, 2008, is
amended as follows:

Paragraph 6005 Class E Airspace Extending Upward from 700 feet or
More Above the Surface of the Earth.

* * * * *

AAL AK E5 Oooguruk Drill Site Helipad, AK [New]

Oooguruk, Oooguruk Drill Site Helipad, AK
    (Lat. 70[deg]29[min]44[sec] N., long. 150[deg]15[min]12[sec] W.)

    That airspace extending upward from 700 feet above the surface
within a 6-mile radius of the Oooguruk Drill Site Helipad, AK; and
that airspace extending upward from 1,200 feet above the surface
within a 73-mile radius of the Oooguruk Drill Site Helipad, AK,
excluding that portion within R2204 when R2204 is active.
* * * * *

AAL AK E5 Oooguruk Tie-in Helipad, AK [New]

Oooguruk, Oooguruk Tie-in Helipad, AK
    (Lat. 70[deg]24[min]51[sec] N., long. 150[deg]01[min]07[sec] W.)

    That airspace extending upward from 700 feet above the surface
within a 6-mile radius of the Oooguruk Tie-in Helipad AK, excluding
that portion within R2204 when R2204 is active; and that airspace
extending upward from 1,200 feet above the surface within a 73-mile
radius of the Oooguruk Tie-in Helipad, AK, excluding that portion
within R2204 when R2204 is active.
* * * * *

    Issued in Anchorage, AK, on August 20, 2009.
James L. Krause,
Acting Manager, Alaska Flight Services Information Area Group.
[FR Doc. E9-21061 Filed 9-2-09; 8:45 am]

BILLING CODE 4910-13-P


UNITED STATES ENVIRONMENTAL PROTECTION AGENCY

WASHINGTON, D.C. 20460

OFFICE OF

PREVENTION, PESTICIDES AND

TOXIC SUBSTANCES

MEMORANDUM

PC Code:	128887

DP Barcode:	358877, 358880, 358882, 358885

SUBJECT:	Tier 1 Drinking Water Assessment for the DuPont EXPRESS®
Herbicide Containing the Active Ingredient Tribenuron-Methyl

TO:		James Tompkins, Risk Manager

		Registration Division (7505C)

FROM:	Wm. J. Shaughnessy, PhD, Environmental Scientist

		Environmental Risk Branch II

		Environmental Fate and Effects Division

THROUGH:	Tom Bailey, PhD, Chief

		Environmental Risk Branch II

		Environmental Fate and Effects Division

DATE:	June 15 , 2009

	This memorandum presents the results of a Tier 1 drinking water
assessment of EXPRESS and its active ingredient tribenuron-methyl for
broadcast spray on OPTIMUM®GAT field corn and OPTIMUM®GAT soybeans for
pre-plant, post-emergence, and post-harvest control of certain broadleaf
weeds.  The acute estimated environmental concentrations (EECs) in
surface water as predicted by the FIRST model ranged from 2.57 – 2.88
ppb.  The chronic EECs ranged from 0.76 – 0.86 ppb.  The SCI-GROW
model was used by EFED to estimate ground water concentrations from the
use of this herbicide.  The groundwater EEC as predicted by the SCI-GROW
model was 4.95E-03 ppb.  These EECs are lower than the EECs derived in a
2006 drinking water assessment (DWA) completed by EFED.  In that
assessment the acute and chronic surface water EECs predicted by the
FIRST model were 4.1 ppb and 2.7 ppb, respectively.  The groundwater
acute and chronic EEC as predicted by the SCI-GROW model was 6.8 ppb.
Therefore, EFED recommends using the 2006 results to predict potential
health risks associated with tribenuron-methyl concentrations in surface
and groundwater.

BACKGROUND

EXPRESS® is a water soluble granule which is mixed in water and applied
aerially and as a uniform broadcast spray.  The label allows for up to
three applications per growing season for a total of 0.063 lb, of
EXPRESS® per acre (lb. a.i./A) per growing season.  Its mode of action
is an ALS-inhibitor herbicide.   These herbicides slowly starve affected
plants of amino acids eventually leading to inhibition of DNA synthesis.

	In July 2004 a Tier 1 drinking water assessment was completed for
tribenuron-methyl use on wheat, barley and fallow, oats, cotton, and
flax and canola).  Application rates ranged from 0.005 to 0.016 lb
a.i./A.  The number of applications was limited to once per year.  EFED
used the Food Quality Protection Act (FQPA) Index Reservoir Screening
Tool (FIRST) model to estimate drinking water concentrations in surface
waters.  The Screening Concentration in Ground Water (SCI-GROW) model
was used by EFED to estimate ground water concentrations from use of the
herbicide.  The estimated acute environmental concentrations (EECs) as
predicted by the FIRST model ranged from 0.179 – 1.386 ppb.  The
chronic estimated environmental concentrations (EECs) ranged from 0.053
– 0.413 ppb.  Groundwater EECs as predicted by the SCI-GROW model
ranged from 0.0005 – 0.0013 ppb.

	EFED also completed a drinking water assessment of tribenuron-methyl
for use on sunflower, cotton, field corn, sorghum, soybean, canola,
flax, and rice in October 2006.  In this assessment the FIRST and
SCI-GROW modeling was based on a use rate of three (3) aerial
applications of 0.015 lb a.i./A, 14 days apart.  The acute and chronic
surface water EECs predicted by the FIRST model were 4.1 ppb and 2.7
ppb, respectively.  The groundwater acute and chronic EEC as predicted
by the SCI-GROW model was 6.8 ppb.

ENVIRONMENTAL FATE

	Tribenuron-methyl is non-persistent but very mobile in soils. The
primary routes of dissipation for tribenuron-methyl are acid and neutral
hydrolysis and microbial degradation with half-lives of 1-6 days in acid
environments (shallow wells) and 4-30 days in more basic environments.
The field dissipation half-lives (based on lysimeters) range from <5
days in acid soils to 19 days in soils with a basic pH.
Tribenuron-methyl is also very mobile with Kads values of 0.1-1.7 ml/g,
and may move laterally to surface water or downward to ground water.
However, very little mobility was observed in lysimeters used in field
studies.

		The rate of degradation due to chemical processes varies widely.  The
half-lives in pH 5 and 7 aqueous buffered solutions were <1 and 3-6
days, respectively.  Degradation was negligible in pH 9 solutions.  The
major degradates were the phenyl portion of the molecule (saccharin) and
the triazine portion of the molecule (triazine amine).  In the aqueous
photolysis study, the dark control adjusted half-lives for pH 7 and 9
triazine-labeled solutions were 103 days and 358 days, respectively.  In
pH 5 solutions, the rate of degradation was identical for both dark
control and irradiated solutions.   Soil photolysis also degraded
triazine and phenyl-labeled tribenuron-methyl, with dark-control
adjusted half-lives in Gardena silt loam of 23 and 5 days, respectively.
 The major degradates were saccharin and triazine amine.

		Microbial degradation also appears to metabolize parent
tribenuron-methyl.  In aerobic silt loam soils, the calculated
half-lives were 1.4-2.2 days in an acid soil and 18.3-30.7 days in a
basic soil.   The major metabolite was triazine amine.  Under anaerobic
aquatic conditions the calculated total system half-lives for phenyl and
triazine labels ranged from 2-2.6 days for the Landenberg system (low
pH) and 4.9-11.3 days for the Bradenton system (high pH).  Triazine
amine and saccharin were the major degradates, which were primarily
associated with the water phase.  In field dissipation studies using
lysimeters, tribenuron-methyl dissipated with calculated half-lives of
5.3 and 2.1 days in Idaho and Illinois, respectively.  These half-lives
are consistent with the aerobic soil metabolism half-lives (1.4-18.3
days) and less persistence in acidic conditions.  The primary
metabolites were triazine amine and saccharin.  In field studies in
Delaware, the half-lives were <2 days for parent compound in an acid
soil.  In Madera, CA, the half-life of tribenuron-methyl was 19 days in
a high pH soil.  Again, triazine amine and saccharin were the major
metabolites found in the studies.  In all the field studies, minimal
leaching of residues was observed.

Tribenuron-methyl was very mobile in tested soils with Kf values of
0.1-1.7 ml/g and Kfoc values of 10-74 ml/g.  Adsorption was inversely
related to soil pH (r2=0.90).  Desorption Kf values ranged from 0.3-2.2
ml/g, with Kfoc values of 29-69 ml/g.  Triazine amine was very mobile to
mobile in soil.  Adsorption Kf values ranged from 0.93 to 3.18 ml/g,
with Kfoc values of 53-138 ml/g.  Desorption Kf values ranged from 1.52
to 3.88 ml/g, with Kfoc values from 69-169 ml/g.   Sorption was related
to clay content (r2=0.99), soil organic carbon (r2=0.23), and soil pH
(r2=0.99).  The correlation with soil pH is associated with the effect
of the soil pH on the clay in the tested soils.   N-demethyl triazine
amine, a metabolite of tribenuron-methyl, was also very mobile in soil.
Adsorption Kf values ranged from 0.1 to 0.6 ml/g, with Kfoc values of
12-26 ml/g.  Desorption Kf values were only possible for the sandy loam
soil (1.1 ml/g) because of limited sorption.  The Kfoc value was 46
ml/g.  Sorption was related to clay content (r2=0.94), soil organic
carbon (r2=0.44), and soil pH (r2=0.95).  The correlation with soil pH
is associated with the effect of the soil pH on the clay in the tested
soils.

FINDINGS AND CONCLUSIONS

	In this assessment, the FIRST (Version 1.1.0) and SCI-GROW (Version
2.3) models were used to predict the estimated environmental
concentrations (EECs) in surface and groundwater, respectively, for
aerial applications on OPTIMUM GAT corn and soybean.  While the product
label allows for up to three applications per growing season with the
total amount of active ingredient applied not to exceed 0.063 lb.
a.i./A, for modeling purposes the number of applications was limited to
once per year.  EFED assumed that the more conservative model EECs would
be achieved by using a single application at the maximum application
rate.    Input parameters for the FIRST model runs for applications on
corn and soybean are presented in Table 1.  Model output is presented in
Table 2 and 3.    The acute EECs as predicted by the FIRST model ranged
from 2.57 – 2.88 ppb.  The chronic EECs ranged from 0.76 – 0.86 ppb.
 The SCI-GROW model was used by EFED to estimate ground water
concentrations from use of the herbicide.  The groundwater EEC as
predicted by the SCI-GROW model was 4.95E-03 ppb.  The model input
parameters and output results for the SCI-GROW model are presented in
Table 4.

The EECs predicted by the models in the 2004, 2006 and the current
assessment are different and are proportionate to their varying use
rates and application methods.

Table 1.  FIRST Model Input Parameters for Tribenuron-methyl

Model Input	Value	Comments

Max. application rate (lb. a.i./A)	0.063	DuPont Express Herbicide Label

No. of applications per year	1	The label allows for up to three
applications per growing season at a rate not to exceed 0.063 lb. a.i./A
per growing season; 1 is used to yield more conservative model results

Percent cropped area:

    Corn

    Soybean

46

41	From model input guidance for specific crops

Kd	0.3	MRID 46101501

Aerobic soil metabolism half-life (days)	63	MRID 40245522

Upper 90th confidence bound on mean of non-linear half-lives

Is this pesticide to be wetted-in?	No	Label

Method of application	Aerial spray	Label

Water solubility (mg/L) @ 20°C, pH 7	2040
http://sitem.herts.ac.uk/aeru/footprint/en/

Aerobic aquatic metabolism half-life (days)	126	2*63 days (aerobic soil
metabolism half-life) per input guidance.

Aqueous photolysis half-life (days) at pH 7	103	MRID 40245520

Table 2.  FIRST Model Output - Corn

RUN No. 1 FOR Tribenuron-methyl ON OPTIMUM GAT Corn  *INPUT VALUES*

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

RATE (#/AC)	  No.APPS &	SOIL	SOLUBIL	APPL TYPE	%CROPPED	INCORP

ONE (MULT)	   INTERVAL	 Kd	(PPM)		(%DRIFT)	AREA		(IN)

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

0.063		     1	1	0.30	2040		AERIAL (16.0)	46.0	   0.0

FIELD AND RESERVOIR HALFLIFE VALUES (DAYS)

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

METABOLIC	   DAYS UNTIL   HYDROLYSIS  PHOTOLYSIS  METABOLIC  COMBINED

(FIELD)	   RAIN/RUNOFF	(RESERV.)    (RES.-EFF)	(RESERV.)	  (RESERV.)

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

63.0		     	2		N/A	          103.0-12772.0	      126.0	      124.77

UNTREATED WATER CONC  (MICROGRAMS/LITER (PPB)) Ver 1.1.0  Jan. 1, 2007

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

     PEAK DAY (ACUTE)	ANNUAL AVERAGE (CHRONIC)

       CONCENTRATION		CONCENTRATION

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

0.86

Table 3.  FIRST Model Output - Soybean

RUN No. 2 FOR Tribenuron-methyl ON OPTIMUM GAT Soybean  *INPUT VALUES*

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

RATE (#/AC)	  No.APPS &	SOIL	SOLUBIL	APPL TYPE	%CROPPED	INCORP

ONE (MULT)	   INTERVAL	 Kd	(PPM)		(%DRIFT)	AREA		(IN)

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

0.063		     1	1	0.30	2040		AERIAL (16.0)	41.0	   0.0

FIELD AND RESERVOIR HALFLIFE VALUES (DAYS)

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

METABOLIC	   DAYS UNTIL   HYDROLYSIS  PHOTOLYSIS  METABOLIC  COMBINED

(FIELD)	   RAIN/RUNOFF	(RESERV.)    (RES.-EFF)	(RESERV.)	  (RESERV.)

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

63.0		     	2		N/A	          103.0-12772.0	      126.0	      124.77

UNTREATED WATER CONC  (MICROGRAMS/LITER (PPB)) Ver 1.1.0  Jan. 1, 2007

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

     PEAK DAY (ACUTE)	ANNUAL AVERAGE (CHRONIC)

       CONCENTRATION		CONCENTRATION

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

0.76

Table 4.  SCI-GROW Model Input and Output

Crop		Application	      No. of	       Median Koc    Aerobic Soil	 EEC
(ppb)

Rate (lb. a.i./A)1   Applications    (mL/g)2	        Metabolism

						        Half-life (days)

        (Average) 3

Corn		      0.063	             1		  15		   9.9	     	  4.95E-03

Soybean	      0.063	             1		  15		   9.9	     	  4.95E-03

 Product label

2 MRID 46101501

3 MRID 40245522

Monitoring Data

EFED consulted the   HYPERLINK
"http://infotrek.er.usgs.gov/traverse/f?p=NAWQA:HOME:0"  USGS National
Water Quality Assessment Data Warehouse  for available groundwater and
surface water quality data for tribenuron-methyl.  Approximately 1000
monitoring station records nationwide were reviewed.  All reported
values were below detection limits.


[Federal Register Volume 80, Number 22 (Tuesday, February 3, 2015)]
[Notices]
[Pages 5851-5853]
[FR Doc No: 2015-02065]

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

SECURITIES AND EXCHANGE COMMISSION

Investment Company Act Release No. 31435; 812-14349 Trust for
Professional Managers and William Blair & Company L.L.C.; Notice of
Application

January 28, 2015.
AGENCY: Securities and Exchange Commission (``Commission'').

ACTION: Notice of an application under section 6(c) of the Investment
Company Act of 1940 (``Act'') for an exemption from section 15(a) of
the Act and rule 18f-2 under the Act, as well as from certain
disclosure requirements.

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

SUMMARY: Summary of Application: Applicants request an order that would
permit them to enter into and materially amend subadvisory agreements
without shareholder approval and that would grant relief from certain
disclosure requirements.

Applicants:  Trust for Professional Managers (the ``Trust'') and
William Blair & Company L.L.C. (the ``Initial Advisor'').

DATES: Filing Dates: The application was filed August 18, 2014, and
amended on November 18, 2014.

Hearing or Notification of Hearing:  An order granting the requested
relief will be issued unless the Commission orders a hearing.
Interested persons may request a hearing by writing to the Commission's
Secretary and serving applicants with a copy of the request, personally
or by mail. Hearing requests should be received by the Commission by
5:30 p.m. on February 23, 2015, and should be accompanied by proof of
service on applicants, in the form of an affidavit or, for lawyers, a
certificate of service. Pursuant to rule 0-5 under the Act, hearing
requests should state the nature of the writer's interest, any facts
bearing upon the desirability of a hearing on the matter, the reason
for the request, and the issues contested. Persons who wish to be
notified of a hearing may request notification by writing to the
Commission's Secretary.

ADDRESSES: Secretary, U.S. Securities and Exchange Commission, 100 F
Street NE., Washington, DC 20549-1090. Applicants: John P. Buckel,
Trust for Professional Managers, 615 East Michigan Street, Milwaukee,
WI 53202; Richard W. Smirl, William Blair & Company, L.L.C., 222 West
Adams Street, Chicago, IL 60606.

FOR FURTHER INFORMATION CONTACT: Jane H. Kim, at<PHONE_NUMBER> or
Melissa Harke, Branch Chief, at<PHONE_NUMBER> (Chief Counsel's Office,
Division of Investment Management).

SUPPLEMENTARY INFORMATION: The following is a summary of the
application. The complete application may be obtained via the
Commission's Web site by searching for the file number, or for an
applicant using the Company name box, at http://www.sec.gov/search/search.htm or by calling<PHONE_NUMBER>.

Applicants' Representations

    1. The Trust, a Delaware statutory trust, is registered under the
Act as an open-end management investment company. The Trust is
organized as a series investment company and currently consists of 34
series, one of which is advised by the Initial Advisor.\1\ The Initial
Advisor is a limited liability company organized under Delaware law.
The Initial Advisor is, and any other Advisor will be, registered as an
investment adviser under the Investment Advisers Act of 1940
(``Advisers Act''). The Advisor will serve as the investment adviser to
each Fund pursuant to an investment advisory agreement with the Trust
(each

an ``Advisory Agreement'' and collectively, the ``Advisory
Agreements'').\2\ Each Advisory Agreement was or will have been
approved by each Fund's respective shareholder(s) and the board of
trustees of the Trust (``Board''), including a majority of the trustees
who are not ``interested persons,'' as defined in section 2(a)(19) of
the Act, of the Trust, the Fund, or the Advisor (``Independent
Trustees'') in the manner required by sections 15(a) and 15(c) of the
Act and rule 18f-2 under the Act.
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    \1\ Applicants are not requesting relief for any series other
than those advised by the Advisor (as defined below). Applicants
request relief with respect to any existing and any future series of
the Trust or any other registered open-end management company that:
(a) Is advised by the Initial Advisor or a person controlling,
controlled by, or under common control with the Initial Advisor or
its successor (each, an ``Advisor''); (b) uses the manager of
managers structure (``Manager of Managers Structure'') described in
the application; and (c) complies with the terms and conditions of
the requested order (any such series, a ``Fund'' and collectively,
the ``Funds''). The only existing registered open-end management
investment company that currently intends to rely on the requested
order is named as an applicant, and the only Fund that currently
intends to rely on the requested order is the William Blair
Directional Multialternative Fund. For purposes of the requested
order, ``successor'' is limited to an entity that results from a
reorganization into another jurisdiction or a change in the type of
business organization. If the name of any Fund contains the name of
a Subadvisor (as defined below), that name will be preceded by the
name of the Advisor.
    \2\ Each future investment advisory agreement between an Advisor
and a Fund is also included in the term ``Advisory Agreement''. The
Initial Advisor currently serves as investment advisor only to the
William Blair Directional Multialternative Fund, a series of the
Trust, under the Advisory Agreement.
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    2. Under the terms of each Advisory Agreement, the Advisor will
provide each Fund with overall management services and, as it deems
appropriate, will continuously review, supervise and administer each
Fund's investment program, subject to the supervision of, and policies
established by, the Board. For the investment management services it
will provide to each Fund, the Advisor will receive the fee specified
in the Advisory Agreement from such Fund, payable monthly at an annual
rate based on the average daily net assets of the Fund. The Advisory
Agreement permits the Advisor to delegate certain responsibilities to
one or more subadvisors (each a ``Subadvisor''), subject to the
approval of the Board.\3\
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    \3\ As of the date of the amended application, the Advisor has
entered into subadvisory agreements (``Subadvisory Agreements'')
with Buckingham Capital Management, Inc., Cube Capital LLP, FSI
Group, LLC, Havens Advisors, L.L.C. None of the existing Subadvisors
is affiliated with the Advisor.
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    3. Each Subadvisor will be an investment adviser as defined in
section 2(a)(20) of the Act and will be registered with the Commission
as an ``investment adviser'' under the Advisers Act. The Advisor will
evaluate, allocate assets to and oversee the Subadvisors, and make
recommendations about their hiring, termination, and replacement to the
Board, at all times subject to the authority of the Board. The Advisor
will compensate the Subadvisors out of the advisory fee paid by a Fund
to the Advisor under the Advisory Agreement.
    4. Applicants request an order to permit the Advisor, subject to
Board approval, to select certain Subadvisors to manage all or a
portion of the assets of a Fund or Funds pursuant to a Subadvisory
Agreement and materially amend Subadvisory Agreements without obtaining
shareholder approval. The requested relief will not extend to any
Subadvisor that is an affiliated person, as defined in section 2(a)(3)
of the Act, of the Trust or of the Advisor, other than by reason of
serving as a Subadvisor to one or more of the Funds (``Affiliated
Subadvisor'').\4\
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    \4\ Shareholder approval of a Subadvisory Agreement with an
Affiliated Shareholder will be obtained. If a Subadvisor change is
proposed for a fund with an Affiliated Subadvisor, the Board,
including a majority of the Independent Trustees, will make a
separate finding, reflected in the Trust's Board minutes, that the
change is in the best interests of the Fund and its shareholders and
does not involve a conflict of interest from which the Advisor or
the Affiliated Subadvisor derives an inappropriate advantage. The
Initial Advisor currently intends to enter into Subadvisory
Agreements only with non-affiliated Subadvisors.
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    5. Applicants also request an order exempting the Funds from
certain disclosure provisions described below that may require the
applicants to disclose fees paid by the Advisor to each Subadvisor.
Applicants seek an order to permit the Trust to disclose for a Fund (as
both a dollar amount and as a percentage of the Fund's net assets): (a)
The aggregate fees paid to the Advisor and any Affiliated Subadvisor;
and (b) the aggregate fees paid to Subadvisors other than Affiliated
Subadvisors (collectively, ``Aggregate Fee Disclosure''). Any Fund that
employs an Affiliated Subadvisor will provide separate disclosure of
any fees paid to the Affiliated Subadvisor.

Applicants' Legal Analysis

    1. Section 15(a) of the Act provides, in relevant part, that is
unlawful for any person to act as an investment adviser to a registered
investment company except pursuant to a written contract that has been
approved by a vote of a majority of the company's outstanding voting
securities. Rule 18f-2 under the Act provides that each series or class
of stock in a series investment company affected by a matter must
approve that matter if the Act requires shareholder approval.
    2. Form N-1A is the registration statement used by open-end
investment companies. Item 19(a)(3) of Form N-1A requires disclosure of
the method and amount of the investment adviser's compensation.
Applicants state that this provision may require a Fund to disclose the
fees the Advisor pays to each Subadvisor.
    3. Rule 20a-1 under the Act requires proxies solicited with respect
to a registered investment company to comply with Schedule 14A under
the Securities Exchange Act of 1934. Items 22(c)(1)(ii), 22(c)(1)(iii),
22(c)(8) and 22(c)(9) of Schedule 14A, taken together, require a proxy
statement for a shareholder meeting at which the advisory contract will
be voted upon to include the rate of compensation of the investment
adviser, the aggregate amount of the investment adviser's fees, a
description of the terms of the contract to be acted upon, and, if a
change in the advisory fee is proposed, the existing and proposed fees
and the difference between the two fees. Applicants believe that these
provisions may require a Fund to disclose the fees the Advisor pays to
each Subadvisor in proxy statements for shareholder meetings at which
fees would be established, or action would be taken on an advisory
contract.
    4. Regulation S-X sets forth the requirements for financial
statements required to be included as part of a registered investment
company's registration statement and shareholder reports filed with the
Commission. Sections 6-07(2)(a), (b), and (c) of Regulation S-X require
a registered investment company to include in its financial statement
information about investment advisory fees. Applicants state that these
provisions may be deemed to require the Funds' financial statements to
include information concerning fees paid to the Subadvisors.
    5. Section 6(c) of the Act provides that the Commission may exempt
any person, security, or transaction or any class or classes of
persons, securities, or transactions from any provisions of the Act, or
from any rule thereunder, if such exemption is necessary or appropriate
in the public interest and consistent with the protection of investors
and the purposes fairly intended by the policy and provisions of the
Act. Applicants state that the requested relief meets this standard for
the reasons discussed below.
    6. Applicants state that, by investing in a Fund, shareholders will
hire the Advisor to manage the Fund's assets in conjunction with using
its investment subadvisor selection and monitoring process. Applicants
assert that, from the perspective of the shareholder, the role of the
Subadvisors is substantially equivalent to that of the individual
portfolio managers employed by traditional investment company advisory
firms. Applicants believe that requiring shareholder approval of each
Subadvisory Agreement would impose unnecessary delays and expenses on
the Funds and may preclude the Funds from acting promptly when the
Advisor and Board consider it appropriate to hire Subadvisors or amend
Subadvisory Agreements. Applicants note that the Advisory Agreements
and any Subadvisory Agreements with Affiliated Subadvisors will remain
subject to the shareholder approval requirements of

section 15(a) of the Act and rule 18f-2 under the Act.
    7. If a new Subadvisor is retained in reliance on the requested
order, the Funds will inform shareholders of the hiring of a new
Subadvisor pursuant to the following procedures (``Modified Notice and
Access Procedures''): (a) Within 90 days after a new Subadvisor is
hired for any Fund, that Fund will send its shareholders either a
Multi-manager Notice or a Multi-manager Notice and Multi-manager
Information Statement; \5\ and (b) the Fund will make the Multi-manager
Information Statement available on the Web site identified in the
Multi-manager Notice no later than when the Multi-manager Notice (or
Multi-manager Notice and Multi-manager Information Statement) is first
sent to shareholders, and will maintain it on that Web site for at
least 90 days. Applicants assert that a proxy solicitation to approve
the appointment of new Subadvisors would provide no more meaningful
information to shareholders than the proposed Multi-manager Information
Statement. Moreover, as indicated above, the applicable Board would
comply with the requirements of sections 15(a) and 15(c) of the Act
before entering into or amending Subadvisory Agreements.
---------------------------------------------------------------------------

    \5\ A ``Multi-manager Notice'' will be modeled on a Notice of
Internet Availability as defined in rule 14a-16 under the Exchange
Act, and specifically will, among other things: (a) Summarize the
relevant information regarding the new Subadvisor; (b) inform
shareholders that the Multi-manager Information Statement is
available on a Web site; (c) provide the Web site address; (d) state
the time period during which the Multi-manager Information Statement
will remain available on that Web site; (e) provide instructions for
accessing and printing the Multi-manager Information Statement; and
(f) instruct the shareholder that a paper or email copy of the
Multi-manager Information Statement may be obtained, without charge,
by contacting the Funds.
    A ``Multi-manager Information Statement'' will meet the
requirements of Regulation 14C, Schedule 14C and Item 22 of Schedule
14A under the Exchange Act for an information statement, except as
modified by the requested order to permit Aggregate Fee Disclosure.
Multi-manager Information Statements will be filed electronically
with the Commission via the EDGAR system.
---------------------------------------------------------------------------

    8. Applicants assert that the requested disclosure relief will
benefit shareholders of the Funds because it will improve the Advisor's
ability to negotiate the fees paid to Subadvisors. Applicants state
that the Advisor may be able to negotiate rates that are below a
Subadvisor's ``posted'' amounts if the Advisor is not required to
disclose the Subadvisors' fees to the public.

Applicants' Conditions

    Applicants agree that any order granting the requested relief will
be subject to the following conditions:
    1. Before a Fund may rely on the order requested in the
application, the operation of the Fund in the manner described in the
application will be approved by a majority of the Fund's outstanding
voting securities, as defined in the Act, or, in the case of a Fund
whose public shareholders purchase shares on the basis of a prospectus
containing the disclosure contemplated by condition 2 below, by the
sole initial shareholder before offering the Fund's shares to the
public.
    2. The prospectus for each Fund will disclose the existence,
substance, and effect of any order granted pursuant to the application.
Each Fund will hold itself out to the public as employing the Manager
of Managers Structure described in the application. The prospectus will
prominently disclose that the Advisor has ultimate responsibility
(subject to oversight by the Board) to oversee the Subadvisors and
recommend their hiring, termination, and replacement.
    3. Funds will inform shareholders of the hiring of a new Subadvisor
within 90 days after the hiring of a new Subadvisor pursuant to the
Modified Notice and Access Procedures.
    4. The Advisor will not enter into a Subadvisory Agreement with any
Affiliated Subadvisor without that agreement, including the
compensation to be paid thereunder, being approved by the shareholders
of the applicable Fund.
    5. At all times, at least a majority of the Board will be
Independent Trustees, and the nomination and selection of new or
additional Independent Trustees will be placed within the discretion of
the then-existing Independent Trustees.
    6. When a Subadvisor change is proposed for a Fund with an
Affiliated Subadvisor, the Board, including a majority of the
Independent Trustees, will make a separate finding, reflected in the
applicable Board minutes, that such change is in the best interests of
the Fund and its shareholders and does not involve a conflict of
interest from which the Advisor or the Affiliated Subadvisor derives an
inappropriate advantage.
    7. Independent legal counsel, as defined in rule 0-1(a)(6) under
the Act, will be engaged to represent the Independent Trustees. The
selection of such counsel will be within the discretion of the then
existing Independent Trustees.
    8. Each Advisor will provide the Board, no less frequently than
quarterly, with information about the profitability of the Advisor on a
per-Fund basis. The information will reflect the impact on
profitability of the hiring or termination of any Subadvisor during the
applicable quarter.
    9. Whenever a Subadvisor is hired or terminated, the Advisor will
provide the Board with information showing the expected impact on the
profitability of the Advisor.
    10. The Advisor will provide general management services to each
Fund, including overall supervisory responsibility for the general
management and investment of the Fund's assets and, subject to review
and approval of the Board, will (i) set each Fund's overall investment
strategies; (ii) evaluate, select and recommend Subadvisors to manage
all or part of a Fund's assets; (iii) when appropriate, allocate and
reallocate a Fund's assets among multiple Subadvisors; (iv) monitor and
evaluate the performance of Subadvisors; and (v) implement procedures
reasonably designed to ensure that the Subadvisors comply with each
Fund's investment objective, policies and restrictions.
    11. No trustee or officer of the Trust, or of a Fund, or director
or officer of the Advisor, will own directly or indirectly (other than
through a pooled investment vehicle that is not controlled by such
person) any interest in a Subadvisor, except for (a) ownership of
interests in the Advisor or any entity that controls, is controlled by,
or is under common control with the Advisor; or (b) ownership of less
than 1% of the outstanding securities of any class of equity or debt of
a publicly traded company that is either a Subadvisor or an entity that
controls, is controlled by, or is under common control with a
Subadvisor.
    12. Each Fund will disclose in its registration statement the
Aggregate Fee Disclosure.
    13. In the event the Commission adopts a rule under the Act
providing substantially similar relief to that in the order requested
in the application, the requested order will expire on the effective
date of that rule.

    For the Commission, by the Division of Investment Management,
under delegated authority.
Jill M. Peterson,
Assistant Secretary.
[FR Doc. 2015-02065 Filed 2-2-15; 8:45 am]
BILLING CODE 8011-01-P


[Federal Register Volume 88, Number 15 (Tuesday, January 24, 2023)]
[Notices]
[Pages 4169-4170]
[FR Doc No: 2023-01319]

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DEPARTMENT OF ENERGY

Federal Energy Regulatory Commission

[Docket No. AD19-16-000]

Request for Information on Performance Metrics for ISOs, RTOs,
and Utilities in Regions Outside ISOs and RTOs

AGENCY: Federal Energy Regulatory Commission.

ACTION: Notice and request for information.

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

SUMMARY: The Federal Energy Regulatory Commission (Commission or FERC)
encourages Independent System Operators (ISOs), Regional Transmission
Organizations (RTOs), and utilities in regions outside ISOs and RTOs to
submit information within 90 days for the calendar years 2019 to 2022.

DATES: The requested information is due April 24, 2023.

ADDRESSES: Respondents should submit their responses in Docket No.
AD19-16-000 via the Commission's electronic filing (eFiling) system.\1\
Submissions should be made using the OMB-approved Information
Collection Input Spreadsheet (Excel workbook) and the associated Common
Metrics Information Collection User Guide.\2\
---------------------------------------------------------------------------

    \1\ More information on the Commission's eFiling system is
posted at: https://www.ferc.gov/docs-filing/efiling.asp. All
submissions to the Commission must be formatted and filed in
accordance with submission guidelines described at: https://www.ferc.gov/ferc-online/elibrary.
    \2\ Links to the approved Information Collection Input
Spreadsheet (Excel workbook) and the Common Metrics Information
Collection User Guide can be found at: https://www.ferc.gov/industries-data/electric/electric-power-markets/rtoiso-performance-metrics. These two items will not be published in the Federal
Register but will be available in eLibrary.

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

FOR FURTHER INFORMATION CONTACT: Darren Sheets at
_____________________________________-
[email protected] or<PHONE_NUMBER>.

SUPPLEMENTARY INFORMATION: On April 21, 2020, the Office of Management
and Budget (OMB) approved the Federal Energy Regulatory Commission
(Commission or FERC) staff's request for reinstatement and revision of
the FERC-922 (Performance Metrics for ISOs, RTOs, and Regions Outside
ISOs and RTOs, OMB Control No. 1902-0262) information collection, as
discussed in Docket No. AD19-16-000. Consistent with the OMB-approved
information collection, ISOs, RTOs, and utilities in regions outside
ISOs and RTOs are encouraged to submit responsive information by April
24, 2023 for the calendar years 2019 to 2022.\3\ Commission staff most
recently requested responsive information under this OMB-approved
information collection for the years 2014 to 2018 and published a
report based on that information collection on July 23, 2021.\4\
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    \3\ In the OMB request for reinstatement and revision of the
FERC-922 information collection, Commission staff indicated that
respondents would be given 90 days to submit responses to the
information collection.
    \4\ The most recent report, ``Common Metrics Report: Performance
Metrics for ISOs, RTOs, and Regions Outside ISOs and RTOs for the
Reporting Period 2014 to 2018'' can be found at: https://www.ferc.gov/media/2021-common-metrics-docket-no-ad19-16-000-staff-report.

    Dated: January 18, 2023.
Kimberly D. Bose,
Secretary.
[FR Doc. 2023-01319 Filed 1-23-23; 8:45 am]
BILLING CODE 6717-01-P


[Federal Register Volume 76, Number 145 (Thursday, July 28, 2011)]
[Notices]
[Page 45267]
[FR Doc No: 2011-19110]

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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2010-N-0318]

Determination That INVERSINE (Mecamylamine Hydrochloride) Tablet
and Six Other Drug Products Were Not Withdrawn From Sale for Reasons of
Safety or Effectiveness

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice.

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SUMMARY: The Food and Drug Administration (FDA) has determined that the
seven drug products listed in this document were not withdrawn from
sale for reasons of safety or effectiveness. This determination means
that FDA will not begin procedures to withdraw approval of abbreviated
new drug applications (ANDAs) that refer to these drug products, and it
will allow FDA to continue to approve ANDAs that refer to the products
as long as they meet relevant legal and regulatory requirements.

FOR FURTHER INFORMATION CONTACT: Olivia Pritzlaff, Center for Drug
Evaluation and Research, Food and Drug Administration, 10903 New
Hampshire Ave., Bldg. 51, Rm. 6308, Silver Spring, MD 20993-0002, 301-
796-3601.

SUPPLEMENTARY INFORMATION: In 1984, Congress enacted the Drug Price
Competition and Patent Term Restoration Act of 1984 (Pub. L. 98-417)
(the 1984 amendments), which authorized the approval of duplicate
versions of drug products approved under an ANDA procedure. ANDA
applicants must, with certain exceptions, show that the drug for which
they are seeking approval contains the same active ingredient in the
same strength and dosage form as the ``listed drug,'' which is a
version of the drug that was previously approved. ANDA applicants do
not have to repeat the extensive clinical testing otherwise necessary
to gain approval of a new drug application (NDA). The only clinical
data required in an ANDA are data to show that the drug that is the
subject of the ANDA is bioequivalent to the listed drug.
    The 1984 amendments include what is now section 505(j)(7) of the
Federal Food, Drug, and Cosmetic Act (21 U.S.C. 355(j)(7)), which
requires FDA to publish a list of all approved drugs. FDA publishes
this list as part of the ``Approved Drug Products With Therapeutic
Equivalence Evaluations,'' which is generally known as the ``Orange
Book.'' Under FDA regulations, a drug is withdrawn from the list if the
Agency withdraws or suspends approval of the drug's NDA or ANDA for
reasons of safety or effectiveness, or if FDA determines that the
listed drug was withdrawn from sale for reasons of safety or
effectiveness (21 CFR 314.162).
    Under Sec.  314.161(a) (21 CFR 314.161(a)), the Agency must
determine whether a listed drug was withdrawn from sale for reasons of
safety or effectiveness: (1) Before an ANDA that refers to that listed
drug may be approved; (2) whenever a listed drug is voluntarily
withdrawn from sale and ANDAs that refer to the listed drug have been
approved; and (3) when a person petitions for such a determination
under 21 CFR 10.25(a) and 10.30. Section 314.161(d) provides that if
FDA determines that a listed drug was withdrawn from sale for reasons
of safety or effectiveness, the Agency will initiate proceedings that
could result in the withdrawal of approval of the ANDAs that refer to
the listed drug.
    FDA has become aware that the drug products listed in the table in
this document are no longer being marketed. (As requested by the
applicant, FDA withdrew approval of NDA 021039 for AGENERASE
(amprenavir) Oral Solution in the Federal Register of July 21, 2010 (75
FR 42455).)

------------------------------------------------------------------------
       Application No.                Drug                Applicant
------------------------------------------------------------------------
NDA 010251..................  INVERSINE             Targacept, Inc., 200
                               (mecamylamine         East 1st St., Suite
                               hydrochloride         300, Winston Salem,
                               (HCl)) Tablet, 2.5    NC 27101-4165
                               milligrams (mg).
NDA 011552..................  STELAZINE             GlaxoSmithKline, 5
                               (trifluoperazine      Moore Dr., P.O. Box
                               HCl) Injection,       13398, Research
                               Equivalent to (EQ)    Triangle Park, NC
                               2 mg base/            27709-3398
                               milliliter (mL).
NDA 011552..................  STELAZINE             Do.
                               (trifluoperazine
                               HCl) Oral
                               Concentrate, EQ 10
                               mg base/mL.
NDA 016798..................  SINEQUAN (doxepin     Pfizer Laboratories,
                               HCl) Capsules, EQ     Division of Pfizer
                               10 mg base, EQ 25     Inc., 235 East 42nd
                               mg base, EQ 50 mg     St., New York, NY
                               base, EQ 75 mg        10017
                               base, EQ 100 mg
                               base, and EQ 150 mg
                               base.
NDA 017516..................  SINEQUAN (doxepin     Do.
                               HCl) Oral
                               Concentrate, EQ 10
                               mg base/mL.
NDA 019201..................  VOLTAREN (diclofenac  Novartis
                               sodium) Delayed-      Pharmaceuticals
                               Release Tablet, 75    Corp., One Health
                               mg.                   Plaza, East
                                                     Hanover, NJ 07936-
                                                     1080
NDA 021039..................  AGENERASE             GlaxoSmithKline
                               (amprenavir) Oral
                               Solution, 15 mg/mL.
------------------------------------------------------------------------

    FDA has reviewed its records and, under Sec.  314.161, has
determined that the drug products listed in this document were not
withdrawn from sale for reasons of safety or effectiveness.
Accordingly, the Agency will continue to list the drug products listed
in this document in the ``Discontinued Drug Product List'' section of
the Orange Book. The ``Discontinued Drug Product List'' identifies,
among other items, drug products that have been discontinued from
marketing for reasons other than safety or effectiveness.
    Approved ANDAs that refer to the NDAs listed in this document are
unaffected by the discontinued marketing of the products subject to
those NDAs. Additional ANDAs that refer to these products may also be
approved by the Agency if they comply with relevant legal and
regulatory requirements. If FDA determines that labeling for these drug
products should be revised to meet current standards, the Agency will
advise ANDA applicants to submit such labeling.

    Dated: July 25, 2011.
David Dorsey,
Acting Deputy Commissioner for Policy, Planning and Budget.
[FR Doc. 2011-19110 Filed 7-27-11; 8:45 am]
BILLING CODE 4160-01-P