Based on EPA's technical analysis described below, EPA has designated
three full or partial counties in Indiana and two Kentucky counties as
nonattainment for the 24-hour PM2.5 air-quality standard as the
Louisville nonattainment area, based upon currently available
information.

The following is a review of data for relevant factors for the Indiana
portion of the Louisville area.

Factor 1:  Emissions data

For this factor, EPA evaluated county level emission data for the
following PM2.5 components and precursor pollutants:  “PM2.5 emissions
total,” “PM2.5 emissions carbon,” “PM2.5 emissions other,”
“SO2,” “NOx,” “VOCs,” and “NH3.”  “PM2.5 emissions
total” represents direct emissions of PM2.5 and includes: “PM2.5
emissions carbon,” “PM2.5 emissions other”, primary sulfate (SO4),
and primary nitrate.  (Although primary sulfate and primary nitrate,
which are emitted directly from stacks rather than forming in
atmospheric reactions with SO2 and NOx, are part of “PM2.5 emissions
total,” they are not shown in Table 1 as separate items).  “PM2.5
emissions carbon” represents the sum of organic carbon (OC) and
elemental carbon (EC) emissions, and “PM2.5 emissions other”
represents other inorganic particles (crustal).  Emissions of SO2 and
NOx, which are precursors of the secondary PM2.5 components sulfate and
nitrate, are also considered.  VOCs (volatile organic compounds) and NH3
(ammonia) are also potential PM2.5 precursors and are included for
consideration.

Emissions data were derived from the 2005 National Emissions Inventory
(NEI), version 1.  See
http://www.epa.gov/ttn/naaqs/pm/pm25_2006_techinfo.html.

EPA also considered the Contributing Emissions Score (CES) for each
county.  The CES is a metric that takes into consideration emissions
data, meteorological data, and air quality monitoring information to
provide a relative ranking of counties in and near an area.  Note that
this metric is not the exclusive manner for considering data for these
factors.  A more detailed description can be found at
http://www.epa.gov/ttn/naaqs/pm/pm25_2006_techinfo.html#C.

Table 1 shows emissions of PM2.5 and precursor pollutants components
(given in tons per year) and the CES for violating and potentially
contributing counties in the Louisville area.  Counties that are part of
the Louisville nonattainment area for the 1997 PM2.5 NAAQS are shown in
boldface.  Counties are listed in descending order by CES.

Table 1.  PM2.5 24-hour Component Emissions, and CESs.

County	State Recommended Nonattainment?	CES	PM2.5

emissions

total	PM2.5

emissions

carbon	PM2.5

emissions

other	SO2

	NOx

	VOCs

	NH3

Jefferson, KY	No	100	5,941	2,726	3,215	53,066	58,643	38,095	1,628

Floyd, IN	No	33	3,206	285	2,920	57,498	8,169	3,462	258

Clark, IN	No	16	1,398	338	1,060	4,043	5,749	6,049	800

Bullitt, KY	No	6	659	283	376	857	3,140	5,816	182

Oldham, KY	No	6	579	220	359	504	3,306	1,821	254

Harrison, IN	No	5	746	238	507	672	3,423	2,379	1,208

Jefferson, IN	No	3	1,265	168	1,097	75,319	25,214	2,272	341

Clark and Floyd Counties in Indiana both have sizable emissions.  Their
CES ranks them second and third in the area following Jefferson County,
Kentucky.  They rank ahead of Bullitt County.  Jefferson County, Indiana
has a low CES, but it has the largest sulfur dioxide emissions and the
second largest NOx emissions in the area.  Harrison County has a low a
CES and emissions.  Considering the emissions factor, Clark, Floyd, and
Jefferson Counties are good nonattainment candidates in the Indiana
portion of the area.

Table 2 provides the data for CES weighting factors.  The trajectory
factors are used in CES calculations to account for seasonal
meteorology.  For the top 10% of days in both the cold and warm seasons,
wind trajectories were run for a 48 hour period preceding the high
monitor reading.  The amount of time the air mass was over a county
within the mixing height was calculated.  The values were scaled so that
the maximum value is 100.  Thus, the county that is most likely to be
upwind of a monitor on a high concentration day in a season is given a
score of 100.  The scores for the other counties will reflect the
relative likelihood of being upwind.  As the concentration of a
pollutant will decrease as it goes further downwind, a distance
weighting factor is also used in calculating the CES.  The distance
factor listed on Table 2 provides the distance from the center of a
county to the center of the violating county.  If a county is violating,
the distance used is the average distance from the center to the county
line.

  Table 2.  CES Factor Data.

County	CES	Trajectory Factor- Cold	Trajectory Factor- Warm	Distance (mi)

Jefferson, KY	100	100	100	18.9

Floyd, IN	33	98	88	10.8

Clark, IN	16	85	52	9.3

Bullitt, KY	6	89	91	33.2

Oldham, KY	6	88	63	17.7

Harrison, IN	5	85	81	24.8

Jefferson, IN	3	49	13	29.1

Factor 2:  Air quality data

This factor considers the 24-hour PM2.5 design values (in µg/m3) for
air quality monitors in counties in the Louisville area based on data
for the 2005-2007 period.  A monitor’s design value indicates whether
that monitor attains a specified air quality standard.  The 24-hour
PM2.5 standards are met when the 3-year average of a monitor’s 98th
percentile values are 35 µg/m3 or less.  A design value is only valid
if minimum data completeness criteria are met.

The 24-hour PM2.5 design values for counties in the Louisville area are
shown in Table 3.

Table 3.  Air Quality Data

County	State

Recommended

 Nonattainment?	Design Values

2004-2006	Design Values

2005-2007

Jefferson, KY	No	36	39

Floyd, IN	No	32	35

Clark, IN	No	37	40

Bullitt, KY	No	34	36

Jefferson, IN	No	0	0

Oldham, KY	No	0	0

Harrison, IN	No	0	0

In Indiana, Clark County has a violating design value and therefore must
be designated nonattainment.  Floyd County monitors attainment of the
2006 PM2.5 air quality standards.  There is no monitoring data for
Jefferson County, Indiana.  There are also violations in the Kentucky
portion of the Louisville area.  However, the absence of a violating
monitor alone is not a sufficient reason to eliminate counties as
candidates for nonattainment status.  Each county has been evaluated
based on the weight of evidence of the nine factors and other relevant
information.

For purposes of its review, EPA used data available from the Chemical
Speciation Network and the Interagency Monitoring of Protected Visual
Environments (IMPROVE) network to estimate the composition of fine
particle mass on days with the highest fine particle concentrations.
Analysis of these data indicates that the days with the highest fine
particle concentrations in the Louisville area occur about 82% in the
warm season and 18% in the cool season.  In the warm season, the average
chemical composition of the highest days is 67% sulfate, no nitrate, 30%
carbon, and 3% crustal.  In the cool season, the average chemical
composition of the highest days is 50% sulfate, 23% nitrate, 25% carbon,
and 2% crustal.  These data indicate that sources of SO2, NOx, and
direct PM2.5 emissions contribute to violations in the area.

Note:  Eligible monitors for providing design value data generally
include State and Local Air Monitoring Stations (SLAMS) at
population-oriented locations with an FRM  monitor.  All data from
Special Purpose Monitors (SPM) using an FRM is eligible for comparison
to the relevant NAAQS, subject to the requirements given in the October
17, 2006 Revision to Ambient Air Monitoring Regulations (71 FR 61236).
All monitors used to provide data must meet the monitor siting and
eligibility requirements given in 71 FR 61236 to 61328 in order to be
acceptable for comparison to the 24-hr PM2.5 NAAQS for designation
purposes.

Factor 3: Population density and degree of urbanization (including
commercial development)

Table 4 shows the 2005 population for each county in the area being
evaluated, as well as the population density for each county in that
area.  Population data gives an indication of whether it is likely that
population-based emissions might contribute to violations of the 24-hour
PM2.5 standards.

Table 4.  Population

County	State Recommended Nonattainment?	2005 Population	2005 Population
Density (pop/sq mi)

Jefferson, KY	No	   699,051 	1755

Floyd, IN	No	     72,025 	485

Clark, IN	No	   101,625 	270

Bullitt, KY	No	     71,440 	238

Jefferson, IN	No	     32,379 	90

Oldham, KY	No	     53,459 	273

Harrison, IN	No	     36,729 	76

Jefferson County, Kentucky stands out in the Louisville area as having a
much larger population and higher population density that the other
counties.  Clark and Floyd Counties, Indiana and Bullitt County,
Kentucky all have similarly moderate populations.  Jefferson County,
Indiana has a low population and population density.  Factor 3 indicates
that Clark and Floyd Counties are good candidates for being designated
nonattainment in the Indiana portion of Louisville.

Factor 4: Traffic and commuting patterns

This factor considers the number of commuters in each county who drive
to another county within the Louisville area, the percent of total
commuters in each county who commute within the area, as well as the
total Vehicle Miles Traveled (VMT) for each county in millions of miles
(see Table 5).  A county with numerous commuters is generally an
integral part of an urban area and is likely contributing to fine
particle concentrations in the area.

Table 5.  Traffic and Commuting Patterns

County	State Recommended Nonattainment?	2005 VMT

(106 mi)	Number Commuting to any violating counties 	Percent

Commuting to any violating counties 	Number Commuting within/to
statistical area 	Percent

Commuting within/to statistical area

Jefferson, KY	No	    9,030 	312,660 	95 	    322,950 	          98

Clark, IN	No	    1,218 	41,100 	85 	      47,410 	          98

Bullitt, KY	No	       852 	28,570 	94 	      30,160 	          99

Floyd, IN	No	       768 	18,380 	52 	      34,590 	          99

Oldham, KY	No	       526 	13,050 	61 	      21,020 	          98

Harrison, IN	No	       585 	6,200 	36 	      16,550 	          96

Jefferson, IN	No	       382 	660 	4 	        1,130 	            8

The listing of counties on Table 4 reflects a ranking based on the
number of people commuting to other counties.  The counties that are in
the nonattainment area for the 1997 PM2.5 NAAQS are shown in boldface.
The number and percent of commuting to any violating county figures are
all high for Clark County, Indiana along with Jefferson and Bullitt
Counties, Kentucky.  Floyd County, Indiana and Oldham County, Kentucky
show more modest commuting figures.  Harrison County has a modest number
of commuters.  The percent of commuting within the Louisville
statistical area is large for the MSA counties.  A small number and
percent of Jefferson County, Indiana workers commute into the
statistical area.  The VMT and commuting into violating counties data
for Jefferson County, Indiana is also low.  In Indiana, Clark County is
strong candidate for nonattainment and Floyd County is a potential
candidate based on this factor.  Harrison County is a weak candidate.

Note:  The 2005 VMT data used for table 5 and 6 of the 9-factor analysis
has been derived using methodology similar to that described in
“Documentation for the final 2002 Mobile National Emissions Inventory,
Version 3, September 2007, prepared for the Emission Inventory Group,
U.S. EPA.  This document may be found at:
ftp://ftp.epa.gov/EmisInventory/2002finalnei/documentation/mobile/2002_m
obile_nei_version_3_report_092807.pdf.  The 2005 VMT data were taken
from documentation which is still draft, but which should be released in
2008.

Factor 5:  Growth rates and patterns

This factor considers population growth for 2000-2005 and growth in
vehicle miles traveled for 1996-2005 for counties in Louisville area, as
well as patterns of population and VMT growth.  A county with rapid
population or VMT growth is generally an integral part of an urban area
and likely to be contributing to fine particle concentrations in the
area.

Table 6 below shows population, population growth, VMT, and VMT growth
for counties that are included in the Louisville area.  Counties are
listed in descending order based on VMT growth between 1996 and 2005.

Table 6.  Population and VMT Growth and Percent Change.

County	Population (2005)	Population % change (2000-2005)	2005 VMT

(106 mi)	VMT

% change

(1996-2005)

Jefferson, IN	     32,379 	2 	        382 	          24

Harrison, IN	     36,729 	6 	        585 	          23

Oldham, KY	     53,459 	14 	        526 	          19

Jefferson, KY	    699,051 	1 	     9,030 	          18

Bullitt, KY	     71,440 	16 	        852 	          13

Clark, IN	    101,625 	5 	     1,218 	          10

Floyd, IN	     72,025 	2 	        768 	            3

The Indiana counties showed limited population growth.  Jefferson
County, Indiana has the largest VMT percent expansion.  Yet, it still
has the lowest VMT.  Table 6 shows the VMT growth for other area
counties follows closely behind Jefferson County, Indiana.  The growth
rates are not expected to yield significant changes in the distribution
of population in the area, so this factor did not significantly
influence the decision-making process.

Factor 6:  Meteorology (weather/transport patterns)

For this factor, EPA considered data from National Weather Service
instruments and other meteorological monitoring sites in the area.  Wind
direction and wind speed data for 2005-2007 were analyzed, with an
emphasis on “high PM2.5 days” for each of two seasons, an
October-April “cold” season and a May-September “warm” season.
These high days are defined as days where any FRM or FEM air quality
monitors had 24-hour PM2.5 concentrations above 95% on a frequency
distribution curve of PM2.5 24-hour values.

μg/m3 are denoted with a red or black icon.  A dot indicates the day
occurred in the warm season; a triangle indicates the day occurred in
the cool season.  The center of the figure indicates the location of the
air quality monitoring site, and the location of the icon in relation to
the center indicates the direction from which the wind was blowing on
that day.  An icon that is close to the center indicates a low average
wind speed on that day.  Higher wind speeds are indicated when the icon
is further away from the center.

The pollution rose for Louisville is provided as Figure 2.  The winds on
high concentration days during the warm season show a slight tendency to
be from the Northeast or Southwest.  That is along the Ohio River.
Still, the wind direction varies frequently and air quality data showed
violations in several area counties.  In particular, winds on occasion
bring emissions from Jefferson County, Indiana, to the Louisville area,
just as on various occasions winds bring emissions from Clark and Floyd
Counties to the violating monitors in Clark County, Indiana, and
Jefferson and Bullitt Counties, Kentucky.  So, it is appropriate under
this factor to include counties in all directions from Louisville.

Figure 2

Note:  the meteorology factor is also considered in each county’s
Contributing Emissions Score because the method for deriving this metric
included an analysis of trajectories of air masses for high PM2.5 days.

Factor 7:  Geography/topography (mountain ranges or other air basin
boundaries)

The geography/topography analysis evaluates the physical features of the
land that might have an effect on the air shed and, therefore, on the
distribution of PM2.5 over the area.

The Louisville area does not have any geographical or topographical
barriers significantly limiting air-pollution transport within its air
shed.  Therefore, this factor did not play a significant role in the
decision-making process.

Factor 8:  Jurisdictional boundaries

In evaluating the jurisdictional boundary factor, EPA gave special
consideration to areas that were already designated nonattainment in
2005 for violating the 1997 fine particle standards.  Analysis of
chemical composition data in these areas indicates that the same
components that make up most of the PM2.5 mass in the area on an annual
average basis such as sulfate and direct PM2.5 carbon in many eastern
areas also are key contributors to the PM2.5 mass on days exceeding the
24-hour PM2.5 standard.  These data indicate that in many cities, the
same source categories that contribute to violations of the annual
standard also contribute to exceedances of the 24-hour standard.

Most areas that were originally designated nonattainment for the PM2.5
standards still have not attained the air quality standards.  Thus, EPA
has generally concluded that counties that were designated as having
emissions sources contributing to fine particle concentrations which
continue to exceed the 1997 standards (all areas violated the annual
standard, two also violated the previous 24-hour standard) also
contribute to fine particle concentrations on the highest days.  For
this reason, EPA believes that for most existing nonattainment areas,
the nonattainment area for the 2006 24-hour standard should be the same.
 Consideration also should be given to existing boundaries and
organizations as they may facilitate air quality planning and the
implementation of control measures to attain the standard.  Areas
already designated as nonattainment represent important boundaries for
state air quality planning.

The Kentuckiana Regional Planning and Development Agency serves as the
Metropolitan Planning Organization (MPO) for Clark and Floyd Counties in
Indiana.

The Louisville ozone maintenance area is made up of Clark and Floyd
Counties in Indiana and Bullitt, Jefferson, and Oldham Counties in
Kentucky.  The fine particulate nonattainment area designed under the
1997 standards is composed of Clark, Floyd, and a portion of Jefferson
County in Indiana along with Bullitt and Jefferson County, Kentucky.
Thus, under this factor it would be appropriate to include Clark, Floyd,
and a portion of Jefferson County (Madison Township) in Indiana in the
nonattainment area.

Factor 9:  Level of control of emission sources

Under this factor, the existing level of control of emission sources is
taken into consideration.  The emissions data used by EPA in this
technical analysis and provided in Table 1 under Factor 1 represent
emissions levels taking into account any control strategies implemented
in the area before 2005 on stationary, mobile, and area sources.  Data
are presented for PM2.5 components that are directly emitted,
carbonaceous PM2.5 and crustal PM2.5, and for pollutants which react in
the atmosphere to form fine particles such as SO2, NOx, VOC, and
ammonia.

In considering county-level emissions, EPA used data from the 2005
National Emissions Inventory, the most updated version of the national
inventory available at the beginning of the designations process in late
2007.  However, EPA recognized that for certain counties, emissions may
have changed since 2005.  For example, certain power plants or large
sources of emissions in or near this area may have installed emission
controls or otherwise significantly reduced emissions since 2005.  Some
States provided updated information on emissions and emission controls
in their comments to EPA.  EPA considered such additional information in
making final designation decisions.

With regard to nearby power plants, EPA considered information about
whether a specific plant installed federally enforceable emission
controls by December 2008 resulting in significant emissions reductions.
 A control requirement is considered to be federally-enforceable if it
is required by a State regulation adopted in a State implementation
plan, if it is included in a federally-enforceable Title V operating
permit, or if it is required by a consent decree which also requires the
controls to be included in federally enforceable permit upon termination
of the consent decree.  In making final decisions, EPA also considered
whether a facility would continue to emit pollutants which contribute.

Indiana submitted information on the status of controls of Clifty Creek
Station in Jefferson County, Indiana.  This information indicates that
flue gas desulfurization will be installed on all units at this facility
in 2010, selective catalytic reduction is in place on 5 of 6 units, and
this equipment will be operated on a full year basis in the future.
However, this information also indicates that current emissions are
relatively high.  Since EPA is promulgating designations based on
current air quality and current emissions contributing to existing
violations as required by the Act, EPA concludes that Madison Township
(including Clifty Creek Station) has relatively high emissions that
contribute to violations of the air quality standard in the Louisville
area and must be included in the Louisville nonattainment area
notwithstanding the fact that additional controls are planned for this
facility at a future date.

EPA has designated three full or partial counties in Indiana and two
Kentucky counties as nonattainment for the 24-hour PM2.5 air-quality
standard as the Louisville nonattainment area based on the technical
analysis.  In Indiana, EPA is designating Clark and Floyd Counties and
Madison Township of Jefferson County as nonattainment.

EPA Technical Analysis for Vincennes, IN

The Vincennes Micropolitan Statistical Area consists of Knox County.
EPA reviewed the relevant information for this county as well as for
surrounding counties.  There is a violating monitor in Knox County.
Knox County was designated as attaining the 1997 standards.  Indiana
recommended that the Vincennes nonattainment area include only Knox
County.

EPA agrees with Indiana’s recommendation.  Knox County is adjacent to
the Evansville area, an area that includes several counties with high
emissions.  Nevertheless, as discussed in the review of the Evansville
nonattainment area, EPA believes that Vincennes warrants being
designated as a separate nonattainment area from Evansville.  Other
Indiana counties near Knox County have relatively low emissions, and no
other factor warranted inclusion of the counties in the Vincennes
nonattainment area.

Figure 1 is a map of the counties in the nonattainment area and other
relevant information such as the locations and design values of air
quality monitors, and the micropolitan area boundary.

Figure 1

In April 2008, EPA also notified Indiana that a monitor in the Vincennes
area was violating based on 2005-2007 data.  Indiana provided EPA with a
recommendation for this area in May 2008.  Indiana recommended that one
county be designated as “nonattainment” for the 2006 24-hour PM2.5
standard based on air quality data from 2005-2007.  These data are from
Federal Reference Method (FRM) monitors located in the state.

In August 2008, EPA notified Indiana of its intended designations.  In
this letter, EPA also requested that if the State wished to provide
comments on EPA’s intended designation, it should do so by October 20,
2008.  EPA stated that it would consider any additional information
(e.g., on power plants or partial county areas) provided by the state in
making final decisions on the designations.  Indiana provided no
information on emission controls in Knox County.

Based on EPA's technical analysis described below, EPA has designated
one county in the Indiana as nonattainment for the 24-hour PM2.5
air-quality standard as part of the Vincennes nonattainment area, based
upon currently available information.  These counties are listed in the
table below.

The following is a review of data for relevant factors for the Vincennes
area.

Factor 1:  Emissions data

For this factor, EPA evaluated county level emission data for the
following PM2.5 components and precursor pollutants:  “PM2.5 emissions
total,” “PM2.5 emissions carbon,” “PM2.5 emissions other,”
“SO2,” “NOx,” “VOCs,” and “NH3.”  “PM2.5 emissions
total” represents direct emissions of PM2.5 and includes: “PM2.5
emissions carbon,” “PM2.5 emissions other”, primary sulfate (SO4),
and primary nitrate.  (Although primary sulfate and primary nitrate,
which are emitted directly from stacks rather than forming in
atmospheric reactions with SO2 and NOx, are part of “PM2.5 emissions
total,” they are not shown in Table 1 as separate items).  “PM2.5
emissions carbon” represents the sum of organic carbon (OC) and
elemental carbon (EC) emissions, and “PM2.5 emissions other”
represents other inorganic particles (crustal).  Emissions of SO2 and
NOx, which are precursors of the secondary PM2.5 components sulfate and
nitrate, are also considered.  VOCs (volatile organic compounds) and NH3
(ammonia) are also potential PM2.5 precursors and are included for
consideration.

Emissions data were derived from the 2005 National Emissions Inventory
(NEI), version 1.  See
http://www.epa.gov/ttn/naaqs/pm/pm25_2006_techinfo.html.

EPA also considered the Contributing Emissions Score (CES) for each
county.  The CES is a metric that takes into consideration emissions
data, meteorological data, and air quality monitoring information to
provide a relative ranking of counties in and near an area.  Note that
this metric is not the exclusive manner for considering data for these
factors.  A more detailed description can be found at
http://www.epa.gov/ttn/naaqs/pm/pm25_2006_techinfo.html#C.

Table 1 shows emissions of PM2.5 and precursor pollutants components
(given in tons per year) and the CES for violating and potentially
contributing counties in the Vincennes area.  Counties are listed in
descending order by CES.

Table 1.  PM2.5 Related Emissions and Contributing Emissions Score

County	State Recommended Nonattainment?	CES	PM2.5

emissions

total	PM2.5

emissions

carbon	PM2.5

emissions

other	SO2

	NOx

	VOCs

	NH3

Gibson, IN	No	100	6,642	420	6,223	154,782	32,655	3,679	1,921

Pike, IN	No	45	2,412	163	2,249	52,836	18,990	1,206	487

Knox, IN	Yes	19	1,250	178	1,073	7,422	3,793	3,270	1,429

Sullivan, IN	No	10	1,572	189	1,383	20,971	11,354	1,851	643

Gibson and Pike Counties were considered with the Evansville area.  The
emissions from Knox County are modest.  Sullivan County has lower
emissions.  With Gibson and Pike Counties being in the Evansville
nonattainment area, Knox County is the only nonattainment candidate in
the Vincennes area from the emissions factor.

Table 2 provides the data for CES weighting factors.  The trajectory
factors are used in CES calculations to account for seasonal
meteorology.  For the top 10% of days in both the cold and warm seasons,
wind trajectories were run for a 48 hour period preceding the high
monitor reading.  The amount of time the air mass was over a county
within the mixing height was calculated.  The values were scaled so that
the maximum value is 100.  Thus, the county that is most likely to be
upwind of a monitor on a high concentration day in a season is given a
score of 100.  The scores for the other counties will reflect the
relative likelihood of being upwind.  As the concentration of a
pollutant will decrease as it goes further downwind, a distance
weighting factor is also used in calculating the CES.  The distance
factor listed on Table 2 provides the distance from the center of a
county to the center of the violating county.  If a county is violating,
the distance used is the average distance from the center to the county
line.

  Table 2.  CES Factor Data.

County	CES	Trajectory Factor- Cold	Trajectory Factor- Warm	Distance (mi)

Gibson	100	77	85	22.8

Pike	45	82	100	21.2

Knox	19	100	100	12.8

Sullivan	10	89	41	29

Factor 2:  Air quality data

This factor considers the 24-hour PM2.5 design values (in µg/m3) for
air quality monitors in counties in the Vincennes area based on data for
the 2005-2007 period.  A monitor’s design value indicates whether that
monitor attains a specified air quality standard.  The 24-hour PM2.5
standards are met when the 3-year average of a monitor’s 98th
percentile values are 35 µg/m3 or less.  A design value is only valid
if minimum data completeness criteria are met.

The 24-hour PM2.5 design values for counties in the Vincennes area are
shown in Table 3.  Knox County is the only county with air quality data.
 Its design value is above the air quality standards.  However, the
absence of a violating monitor alone is not a sufficient reason to
eliminate counties as candidates for nonattainment status.  Each county
has been evaluated based on the weight of evidence of the nine factors
and other relevant information.

	Table 3.  Air Quality Data

County	State

Recommended

Nonattainment?	Design Values

2004-2006

	Design Values

2005-2007

Knox, IN	Yes	36	36

Gibson, IN	No	0	0

Pike, IN	No	0	0

Sullivan, IN	No	0	0

For purposes of its review, EPA used data available from the Chemical
Speciation Network and the Interagency Monitoring of Protected Visual
Environments (IMPROVE) network to estimate the composition of fine
particle mass on days with the highest fine particle concentrations.
Analysis of these data indicates that the days with the highest fine
particle concentrations in the Vincennes area occur about 80% in the
warm season and 20% in the cool season.  In the warm season, the average
chemical composition of the highest days is 72% sulfate, no nitrate, 24%
carbon, and 3% crustal.  In the cool season, the average chemical
composition of the highest days is 34% sulfate, 34% nitrate, 29% carbon,
and 3% crustal.  These data indicate that sources of SO2, NOx, and
direct PM2.5 emissions contribute to violations in the area.

Note:  Eligible monitors for providing design value data generally
include State and Local Air Monitoring Stations (SLAMS) at
population-oriented locations with an FRM monitor.  All data from
Special Purpose Monitors (SPM) using an FRM is eligible for comparison
to the relevant NAAQS, subject to the requirements given in the October
17, 2006 Revision to Ambient Air Monitoring Regulations (71 FR 61236).
All monitors used to provide data must meet the monitor siting and
eligibility requirements given in 71 FR 61236 to 61328 in order to be
acceptable for comparison to the 24-hr PM2.5 NAAQS for designation
purposes.

Factor 3: Population density and degree of urbanization (including
commercial development)

Table 4 shows the 2005 population for each county in the area being
evaluated, as well as the population density for each county in that
area.  Population data gives an indication of whether it is likely that
population-based emissions might contribute to violations of the 24-hour
PM2.5 standards.  Knox County along with the other area counties all
have low population figures.  This appears to be a mostly rural county.

Table 4.  Population

County	State Recommended Nonattainment?	2005 Population	2005 Population
Density (pop/sq mi)

Knox, IN	Yes	     38,298 	73

Gibson, IN	No	     33,347 	67

Pike, IN	No	     12,766 	37

Sullivan, IN	No	     21,675 	48

Factor 4: Traffic and commuting patterns

This factor considers the number of commuters in each county who drive
to another county within the Vincennes area, the percent of total
commuters in each county who commute within the area, as well as the
total Vehicle Miles Traveled (VMT) for each county in millions of miles
(see Table 5).  A county with numerous commuters is generally an
integral part of an urban area and is likely contributing to fine
particle concentrations in the area.

Table 5.  Traffic and Commuting Patterns

County	State Recommended Nonattainment?	2005 VMT

(106 mi)	Number Commuting to any violating counties	Percent

Commuting to any violating counties 	Number Commuting into statistical
area 	Percent

Commuting into statistical area

Knox, IN	Yes	       448 	15,020 	85 	      14,910 	          84

Gibson, IN	No	       469 	640 	4 	           300 	            2

Sullivan, IN	No	       245 	280 	3 	           280 	            3

Pike, IN	No	       169 	1,920 	34 	           130 	            2

The listing of counties on Table 5 reflects a ranking based on the
number of people commuting to other counties.  The commuting data
suggests the Knox County is separate from the other counties.  Indiana
supplied 2005 commuting data.  About 1,400 workers commute from Illinois
into Knox County.  Only a few hundred people commute into Knox County
from each of the adjacent Indiana counties.  Similarly there is modest
commuting from Knox County into other counties.  This factor suggests
there is not a strong link between Knox County and the Evansville area
counties.  Thus, the commuting data suggests Knox County is separate
from the Evansville area.

Note:  The 2005 VMT data used for table 5 and 6 of the 9-factor analysis
has been derived using methodology similar to that described in
“Documentation for the final 2002 Mobile National Emissions Inventory,
Version 3, September 2007, prepared for the Emission Inventory Group,
U.S. EPA.  This document may be found at:
ftp://ftp.epa.gov/EmisInventory/2002finalnei/documentation/mobile/2002_m
obile_nei_version_3_report_092807.pdf.  The 2005 VMT data were taken
from documentation which is still draft, but which should be released in
2008.

Factor 5:  Growth rates and patterns

This factor considers population growth for 2000-2005 and growth in
vehicle miles traveled for 1996-2005 for counties in Vincennes area, as
well as patterns of population and VMT growth.  A county with rapid
population or VMT growth is generally an integral part of an urban area
and likely to be contributing to fine particle concentrations in the
area.

Table 6 below shows population, population growth, VMT, and VMT growth
for counties that are included in the Vincennes area.  Counties are
listed in descending order based on VMT growth between 1996 and 2005.

Table 6.  Population and VMT Growth and Percent Change.

County	Population (2005)	Population % change (2000-2005)	2005 VMT

(106 mi)	VMT

% change

(1996-2005)

Gibson, IN	     33,347 	2 	        469 	          19

Knox, IN	     38,298 	-2	        448 	          15

Sullivan, IN	     21,675 	0 	        245 	          12

Pike, IN	     12,766 	0 	        169 	            0

Gibson, Knox, and Sullivan Counties have experienced some VMT growth.
All these counties still have low VMT.  The populations of all the
counties kept stable.

The growth rates are not expected to yield significant changes in the
distribution of population in the area, so this factor did not
significantly influence the decision-making process.

Factor 6:  Meteorology (weather/transport patterns)

For this factor, EPA considered data from National Weather Service
instruments and other meteorological monitoring sites in the area.  Wind
direction and wind speed data for 2005-2007 were analyzed, with an
emphasis on “high PM2.5 days” for each of two seasons, an
October-April “cold” season and a May-September “warm” season.
These high days are defined as days where any FRM or FEM air quality
monitors had 24-hour PM2.5 concentrations above 95% on a frequency
distribution curve of PM2.5 24-hour values.

μg/m3 are denoted with a red or black icon.  A dot indicates the day
occurred in the warm season; a triangle indicates the day occurred in
the cool season.  The center of the figure indicates the location of the
air quality monitoring site, and the location of the icon in relation to
the center indicates the direction from which the wind was blowing on
that day.  An icon that is close to the center indicates a low average
wind speed on that day.  Higher wind speeds are indicated when the icon
is further away from the center.

The pollution rose for the Vincennes area is provided in Figure 2.
Winds come from a variety of directions.  So, it was appropriate to
analyze counties in all directions from Knox County.

Figure 2

Note:  the meteorology factor is also considered in each county’s
Contributing Emissions Score because the method for deriving this metric
included an analysis of trajectories of air masses for high PM2.5 days.

Factor 7:  Geography/topography (mountain ranges or other air basin
boundaries)

The geography/topography analysis evaluates the physical features of the
land that might have an effect on the air shed and, therefore, on the
distribution of PM2.5 over the area.

The Vincennes area does not have any geographical or topographical
barriers significantly limiting air-pollution transport within its air
shed.  Therefore, this factor did not play a significant role in the
decision-making process.

Factor 8:  Jurisdictional boundaries

In evaluating the jurisdictional boundary factor, EPA gave special
consideration to areas that were already designated nonattainment in
2005 for violating the 1997 fine particle standards.  However, this area
was designated attainment for the 1997 standards, so nonattainment area
boundaries for the 1997 standards were not a factor in determining this
area’s boundaries.

Knox County is not in any current or former nonattainment areas.  There
is not a metropolitan planning organization for Vincennes.

The Vincennes Micropolitan Statistical area, consisting of Knox County,
is immediately adjacent to the Evansville Metropolitan Statistical Area.
 EPA commonly finds that adjoining metropolitan areas influence their
neighbor’s air quality.  On the other hand, such influences occur
across broad distances in the Eastern United States.  EPA interprets the
instruction in the Clean Air Act to designate areas nearby that
contribute to violations as providing that EPA shall not designate a
single Eastern United States nonattainment area.  Instead, EPA generally
designates adjoining urban areas as separate nonattainment areas.

Factor 9:  Level of control of emission sources

Under this factor, the existing level of control of emission sources is
taken into consideration.  The emissions data used by EPA in this
technical analysis and provided in Table 1 under Factor 1 represent
emissions levels taking into account any control strategies implemented
in the Vincennes area before 2005 on stationary, mobile, and area
sources.  Data are presented for PM2.5 components that are directly
emitted, carbonaceous PM2.5 and crustal PM2.5, and for pollutants which
react in the atmosphere to form fine particles such as SO2, NOx, VOC,
and ammonia.

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 to EPA.  EPA considered such additional information in making final
designation decisions.

With regard to nearby power plants, EPA considered information about
whether a specific plant installed federally enforceable emission
controls by December 2008 resulting in significant emissions reductions.
 A control requirement is considered to be federally-enforceable if it
is required by a State regulation adopted in a State implementation
plan, if it is included in a federally-enforceable Title V operating
permit, or if it is required by a consent decree which also requires the
controls to be included in federally enforceable permit upon termination
of the consent decree.  In making final decisions, EPA also considered
whether a facility would continue to emit pollutants which contribute to
PM2.5 exceedances even after emission controls are operational.

There are no large emission sources in Knox County.  Emissions from
large sources outside the Knox County may be controlled by national
control programs or by local measures.  EPA has several national
emission control program reducing the emissions of fine particulate
precursors across the country.  These programs will help lower regional
background levels of fine particulate, helping nonattainment areas
around the nation.  Local control measures put in place to bring other
Midwestern nonattainment areas meet the air quality standards will also
reduce fine particulate and precursor pollution that is transported
beyond the nonattainment area.

Note: EPA has provided a thorough response to each of the specific
comments raised by the State in the Response to Comments document.
Additional information regarding responses to specific State comments
can be found in EPA’s Response to Comments document at   HYPERLINK
"http://www.epa.gov/pmdesignations/2006standards/tech.htm"
http://www.epa.gov/pmdesignations/2006standards/tech.htm .

 EPA designated nonattainment areas for the 1997 fine particle standards
in 2005.  In 2006, the 24-hour PM2.5 standard was revised from 65
micrograms per cubic meter (average of 98th percentile values for 3
consecutive years) to 35 micrograms per cubic meter; the level of the
annual standard for PM2.5 remained unchanged at 15 micrograms per cubic
meter (average of annual averages for 3 consecutive years).

 PAGE

 PAGE   40


MEMORANDUM
To:	David Putney, U.S. Environmental Protection Agency (EPA), OAQPS
From:	Mike Laney and Beatrix Jackson, RTI International
Date:	August 22, 2019
Subject:	Draft Cost impacts of proposed residual risk and technology review amendments to the Taconite Iron Ore Processing NESHAP
_____________________________________________________________________________
Background
The purpose of this memo is to estimate the cost savings associated with the proposed residual risk and technology review (RTR) amendments to the Taconite Iron Ore Processing NESHAP (i.e., 40 CFR part 63, subpart RRRRR). These proposed amendments include the removal of the current requirement for quarterly internal baghouse inspections for each baghouse that is equipped with a bag leak detection system (BLDS) and the reduction of the minimum run time for required Method 5 compliance tests from 2 hours to 1 hour.
Baghouse Inspection
The current taconite NESHAP requires that baghouses be equipped with bag leak detection systems and conduct inspections of the baghouse according to the requirements in 40 CFR 63.9631(a). Under the proposed rule, baghouses equipped with BLDS would not be required to conduct quarterly internal baghouse inspections, as currently required by 40 CFR 63.9631(a)(7).
To estimate the annual cost savings of removing the internal baghouse inspection requirements, the person-hours for each internal inspection requirement was estimated (i.e., 4 hours per inspection). The estimated person-hours for each inspection requirement were then multiplied by the frequency of the required internal inspections (i.e., 4 inspections per year) to estimate the person-hours required for a single baghouse. The total person-hours per year per baghouse was estimated at 16 hours.
Labor rates were based on Bureau of Labor Statistics (BLS) data.[1] An hourly wage of $44.54 was used and a rate of 110 percent was applied to account for overhead costs, or $48.99. The fully burdened hourly wage used was $93.53.
An estimated 75 baghouses would be affected by this amendment.[2] Multiplying the annual person-hours and labor rate by the number of baghouses gives an estimated total cost savings of $112,241 per year. The information used to estimate costs are summarized in Table 1.
Test Run Time Requirement
The current taconite NESHAP requires that each particulate matter Method 5 test run be 2 hours in length for a total 6 hours of testing time. Under the proposed rule, the time for each test run would be reduced from 2 hours to 1 hour. Estimated annual savings per facility, as provided by industry,[2] ranged from $2,000 to $20,000. Total annual savings for the industry would be an estimated $78,000. The estimated cost reductions are summarized in Table 2.
Total Estimated Cost Impacts
The total estimated cost impacts associated with the proposed RTR amendments to the Taconite Iron Ore Processing NESHAP are a savings of about $190,000 per year (i.e., $112,241 per year for the removal of quarterly internal baghouse inspections for baghouses equipped with BLDS plus $78,000 per year for the reduction of Method 5 test runs from 2 hours to 1 hour).
References
1. Bureau of Labor Statistics, Occupational Employment Statistics, Environmental Engineers, May 2018.
2. Email with attachments. Balserak, P., American Iron and Steel Institute, to Putney, D. USEPA. List of Suggested Reg Improvements, March 15, 2019.

Table 1. Cost of Quarterly Internal Baghouse Inspection Required in 40 CFR 63.9631(a)(7)
                            Inspection requirement
                                 Rule citation
                              Required Frequency
                        How requirement is implemented
                          Person-hours per occurrence
                           Occurrences per baghouse
                                 Unit of time
                       Occurrences per baghouse per year
                      Person-hours per baghouse per year
                            Labor rate
($/hour)[a]
                              No. of baghouses[2]
                             Annual cost ($/year)
Internal inspection of BH
                                 63.9631(a)(7)
                                   Quarterly
                               Once per quarter
                                       4
                                                                              1
/quarter
                                       4
                                      16
                                     93.53
                                      75
                                    112,241

Mean hourly wage[1]
 $                  44.54

Mean hourly wage, including 110% overhead
 $                  93.53

Note: Assumed that all baghouses are pulse jet.

Table 2. Cost Reduction to Reduce Test Run Time From 2 Hours to 1 Hour [a]
                                Taconite Plant
                         Estimated Annual Cost Savings
ArcelorMittal Minorca
                                    $4,500
U.S. Steel - Keetac
                                    $2,000
U.S. Steel - Minntac
                                    $15,000
Hibbing Taconite
                                    $8,500
United Taconite
                                    $7,000
Northshore Mining
                                    $20,000
Empire
                                    $10,000
Tilden
                                    $11,000
                                     Total
                                    $78,000

[a] Cost data obtained from email from Paul Balserak (AISI), dated March 15, 2019[2].


[Federal Register Volume 77, Number 234 (Wednesday, December 5, 2012)]
[Notices]
[Pages 72353-72355]
[FR Doc No: 2012-29327]

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

DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2012-N-0813]

Agency Information Collection Activities; Submission for Office
of Management and Budget Review; Comment Request; Applications for Food
and Drug Administration Approval To Market a New Drug; Revision of
Postmarketing Reporting Requirements--Discontinuance

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice.

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

SUMMARY: The Food and Drug Administration (FDA) is announcing that a
proposed collection of information has been submitted to the Office of
Management and Budget (OMB) for review and clearance under the
Paperwork Reduction Act of 1995.

DATES: Fax written comments on the collection of information by January
4, 2013.

ADDRESSES: To ensure that comments on the information collection are
received, OMB recommends that written comments be faxed to the Office
of Information and Regulatory Affairs, OMB, Attn: FDA Desk Officer,
FAX:<PHONE_NUMBER>, or emailed to<EMAIL_ADDRESS>All
comments should be identified with the OMB control number 0910-0699.
Also include the FDA docket number found in brackets in the heading of
this document.

FOR FURTHER INFORMATION CONTACT: Ila S. Mizrachi, Office of Information
Management, Food and Drug Administration, 1350 Piccard Dr., PI50-400B,
Rockville, MD 20850,<PHONE_NUMBER><EMAIL_ADDRESS>
SUPPLEMENTARY INFORMATION: In compliance with 44 U.S.C. 3507, FDA has
submitted the following proposed collection of information to OMB for
review and clearance.

Applications for Food and Drug Administration Approval To Market a New
Drug; Revision of Postmarketing Reporting Requirements--
Discontinuance--(OMB Control Number 0910-0699)--Reinstatement

    FDA published an interim final rule on December 19, 2011 (76 FR
78530), amending its postmarketing reporting regulations implementing
certain provisions of the Federal Food, Drug and Cosmetic Act (FD&C
Act). The provisions of the FD&C Act require manufacturers who are the
sole manufacturers of certain drug products to notify FDA at least 6
months before discontinuance of manufacture of the products. The
interim final rule modified the term ``discontinuance'' and clarified
the term ``sole manufacturer'' with respect to notification of
discontinuance requirements. The broader reporting resulting from these
changes will enable FDA to improve its collection and distribution of
drug shortage information to physician and patient organizations and to
work with manufacturers and other stakeholders to respond to potential
drug shortages.
    Sections 314.81(b)(3)(iii) and 314.91 (21 CFR 314.81(b)(3)(iii) and
314.91) of FDA's regulations implement section 506C of the FD&C Act (21
U.S.C. 355c). Section 314.81(b)(3)(iii) requires entities who are the
sole manufacturers of certain drug products to notify us at least 6
months before discontinuance of manufacture of the product. For the
regulations to apply, a product must meet the following three criteria:
    1. The product must be life supporting, life sustaining, or
intended for use in the prevention of a debilitating disease or
condition;
    2. The product must have been approved by FDA under section 505(b)
or 505(j) (21 U.S.C. 355(b) or 355(j)) of the FD&C Act; and
    3. The product must not have been originally derived from human
tissue and replaced by a recombinant product.
    Under Sec.  314.81(b)(3)(iii)(c), FDA will publicly disclose
information about drug products subject to section 506C that are to be
discontinued. Section 314.91 allows us to reduce the 6-month
notification period if we find that good cause exists for the
reduction. A manufacturer may request that we reduce the notification
period by certifying that good cause for the reduction exists.
    FDA added Sec. Sec.  314.81(b)(3)(iii) and 314.91 to its
regulations in the Federal Register of October 18, 2007 (72 FR 58993).
Sections 314.81(b)(3)(iii) and 314.91 require two new reporting
requirements to FDA that are subject to OMB approval under the PRA:
Notification of Discontinuance and Certification of Good Cause. The
December 19, 2011, interim final rule added two new definitions to
Sec.  314.81(b)(3)(iii): ``Discontinuance'' and ``sole manufacturer.''
The interim final rule clarified the scope of manufacturers required to
report and expanded the range of circumstances required to be reported
to the Agency under Sec.  314.81(b)(3)(iii), but did not change the
substantive content of the reports required to be submitted to the
Agency. This PRA analysis covers the information collection resulting
from the October 18, 2007, final rule and also includes estimates of
how the number of Notifications of Discontinuance and Certifications of
Good Cause may increase as a result of the interim final rule.

A. Notification of Discontinuance

    Under Sec.  314.81(b)(3)(iii), at least 6 months before a sole
manufacturer intends to discontinue manufacture of a drug product
subject to section 506C of the FD&C Act, the manufacturer must send us
notification of the discontinuance. The notification of discontinuance
generally contains the name of the manufacturer, the name of the
product to be discontinued, the reason for the discontinuance, and the
date of discontinuance. FDA will work with relevant manufacturers
during the 6-month notification period to help minimize the effect of
the discontinuance on patients and health care providers, and to
distribute appropriate information about the discontinuance to
physician and patient organizations. The interim final rule added
definitions of ``discontinuance'' and ``sole manufacturer'' to Sec.
314.81(b)(3)(iii). The inclusion of these definitions expands
notification requirements under Sec.  314.81(b)(3)(iii) to additional
discontinuance circumstances and clarifies the scope of manufacturers
who must report discontinuances. The interim final rule also required
that notifications of discontinuance be submitted either electronically
or by telephone according to instructions on FDA's Drug Shortage Web
site at http://www.fda.gov/Drugs/DrugSafety/DrugShortages. This change
ensures that the appropriate offices are timely notified of all
relevant discontinuances. It also reflects existing practice for
submitting notices of discontinuance, and reduces the burden on
industry to submit multiple copies of the notification.

B. Certification of Good Cause

    FDA may reduce the 6-month notification period if we find good
cause for the reduction. As described in Sec.  314.91, a manufacturer
can request a reduction in the notification period by submitting
written certification that good cause exists to the following
designated offices: (1) The Center for Drug Evaluation and Research
(CDER) Drug Shortage Coordinator at the address of the Director of
CDER; (2) the CDER Drug Registration and Listing Team, Division of
Compliance Risk Management and Surveillance in CDER; and (3) the
director of either the CDER

division or the Center for Biologics Evaluation and Research office
that is responsible for reviewing the application. The following
circumstances may establish good cause:
     A public health problem may result from continuation of
manufacturing for the 6-month period (Sec.  314.91(d)(1));
     A biomaterials shortage prevents the continuation of
manufacturing for the 6-month period (Sec.  314.91(d)(2));
     A liability problem may exist for the manufacturer if the
manufacturing is continued for the 6-month period (Sec.  314.91(d)(3));
     Continuation of the manufacturing for the 6-month period
may cause substantial economic hardship for the manufacturer (Sec.
314.91(d)(4));
     The manufacturer has filed for bankruptcy under chapter 7
or 11 of title 11, United States Code (Sec.  314.91(d)(5));
     The manufacturer can stop making the product but still
distribute it to satisfy existing market need for 6 months (Sec.
314.91(d)(6)); or
     Other good cause exists for a reduction in the
notification period (Sec.  314.91(d7) (7)).
    With each certification described previously, the manufacturer must
describe in detail the basis for its conclusion that such circumstances
exist. We require that the written certification that good cause exists
be submitted to the offices identified previously to ensure that our
efforts to address the discontinuance take place in a timely manner.
The interim final rule made no changes to the requirements or process
for certification of good cause.
    Description of Respondents: An applicant that is the sole
manufacturer and who is discontinuing manufacture of a drug product
that meets the following criteria: (1) Is life supporting, life
sustaining, or intended for use in the prevention of a debilitating
disease or condition; (2) was approved by FDA under section 505(b) or
(j) of the FD&C Act; and (3) was not originally derived from human
tissue and replaced by a recombinant product.
    Burden Estimate: The table below provides an estimate of the annual
reporting burden for notification of a product discontinuance and
certification of good cause under Sec. Sec.  314.81(b)(3)(iii) and
314.91, as amended by the interim final rule.
    Notification of Discontinuance: Based on data collected from the
CDER Drug Shortage Coordinator since December 17, 2007, when Sec. Sec.
314.81(b)(3)(iii) and 314.91 went into effect, one manufacturer during
each year reported to FDA a discontinuance of one drug product meeting
the criteria of section 506C and its implementing regulations (i.e.,
the drug product was approved under section 505(b) or (j) of the FD&C
Act, the drug product was ``life-supporting, life-sustaining or
intended for use in the prevention of a debilitating disease or
condition,'' the drug product was produced by a sole manufacturer, and
the drug product was permanently discontinued). CDER's Drug Shortages
Coordinator tracked 220 drug shortages between January and October of
2011. The Agency estimates that 30 percent (66) of these shortages
would relate to discontinuances subject to mandatory reporting under
section 506C of the FD&C Act as a result of the interim final rule.
Adjusting to include an additional 2 months of reporting (November and
December), we estimate that FDA will receive a total of 80
notifications of a discontinuance per year under section 506C of the
FD&C Act, as amended by the interim final rule. Based on experience, a
manufacturer submits only one notification of a discontinuance per
year, thus the total number of manufacturers who would be required to
notify us of a discontinuance would be 80. Therefore, the number of
respondents is estimated to be 80. The hours per response is the
estimated number of hours that a respondent would spend preparing the
information to be submitted with a notification of product
discontinuance, including the time it takes to gather and copy the
statement. Based on experience in working with manufacturers to submit
notifications under Sec.  314.81(b)(3)(iii), we estimate that
approximately 2 hours on average are needed per response. We do not
expect the changes in the interim final rule to affect the number of
hours per response. Therefore, we estimate that respondents will spend
160 hours per year notifying us of a product discontinuance under these
regulations.
    Certification of Good Cause: Based on data collected from the CDER
drug shortage coordinator since 2007, one manufacturer each year
reported a discontinuance of one drug product under section 506C of the
FD&C Act and its implementing regulations. Each manufacturer has the
opportunity under Sec.  314.91 to request a reduction in the 6-month
notification period by certifying to us that good cause exists for the
reduction. The Agency has received no certifications of good cause
since 2007. Although we expect we will receive an increase in the
number of reports of discontinuances as a result of the changes in the
interim final rule, because of the limited circumstances under which
good cause can be requested or would be appropriately granted, we do
not expect a correspondingly large increase in the number of
manufacturers requesting a certification of good cause. We estimate
that only five manufacturers will request a certification of good cause
each year. Therefore, the number of respondents is estimated to be
five. The total annual responses are the total number of certifications
of good cause that are expected to be submitted to us in a year. We
estimate that the total annual responses will remain small, averaging
one response per respondent. The hours per response is the estimated
number of hours that a respondent spends preparing the detailed
information certifying that good cause exists for a reduction in the
notification period, including the time it takes to gather and copy the
documents. We estimate that approximately 16 hours on average are
needed per response. Therefore, we estimate that 80 hours will be spent
per year by respondents certifying that good cause exists for a
reduction in the 6-month notification period under Sec.  314.91.
    In the Federal Register of August 1, 2012 (77 FR 45619), FDA
published a 60-day notice requesting public comment on the proposed
collection of information. No comments were received.
    FDA estimates the burden of this collection of information as
follows:

                                  Table 1--Estimated Annual Reporting Burden\1\
----------------------------------------------------------------------------------------------------------------
                                                     Number of                        Average
         21 CFR Section              Number of     responses per   Total annual     burden per      Total hours
                                    respondents     respondent       responses       response
----------------------------------------------------------------------------------------------------------------
Notification of Discontinuance                80               1              80               2             160
 (314.81(b)(3)(iii).............
Certification of Good Cause                    5               1               5              16              80
 (314.91).......................
                                 -------------------------------------------------------------------------------

    Total.......................  ..............  ..............  ..............  ..............             240
----------------------------------------------------------------------------------------------------------------
\1\There are no capital costs or operating and maintenance costs associated with this collection of information.

    Dated: November 30, 2012.
Leslie Kux,
Assistant Commissioner for Policy.
[FR Doc. 2012-29327 Filed 12-4-12; 8:45 am]
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[Federal Register Volume 86, Number 49 (Tuesday, March 16, 2021)]
[Notices]
[Page 14514]
[FR Doc No: 2021-05432]

=======================================================================
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DEPARTMENT OF TRANSPORTATION

Federal Aviation Administration

[Summary Notice No. 2021-2060]

Petition for Exemption; Summary of Petition Received; Airlines
for America

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

ACTION: Notice.

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

SUMMARY: This notice contains a summary of a petition seeking relief
from specified requirements of Federal Aviation Regulations. The
purpose of this notice is to improve the public's awareness of, and
participation in, the FAA's exemption process. Neither publication of
this notice nor the inclusion or omission of information in the summary
is intended to affect the legal status of the petition or its final
disposition.

DATES: Comments on this petition must identify the petition docket
number and must be received on or before April 5, 2021.

ADDRESSES: Send comments identified by docket number FAA-2021-0079
using any of the following methods:
     Federal eRulemaking Portal: Go to http://www.regulations.gov and follow the online instructions for sending your
comments electronically.
     Mail: Send comments to Docket Operations, M-30; U.S.
Department of Transportation, 1200 New Jersey Avenue SE, Room W12-140,
West Building Ground Floor, Washington, DC 20590-0001.
     Hand Delivery or Courier: Take comments to Docket
Operations in Room W12-140 of the West Building Ground Floor at 1200
New Jersey Avenue SE, Washington, DC 20590-0001, between 9 a.m. and 5
p.m., Monday through Friday, except Federal holidays.
     Fax: Fax comments to Docket Operations at<PHONE_NUMBER>.
    Privacy: In accordance with 5 U.S.C. 553(c), DOT solicits comments
from the public to better inform its rulemaking process. DOT posts
these comments, without edit, including any personal information the
commenter provides, to http://www.regulations.gov, as described in the
system of records notice (DOT/ALL-14 FDMS), which can be reviewed at
http://www.dot.gov/privacy.
    Docket: Background documents or comments received may be read at
http://www.regulations.gov at any time. Follow the online instructions
for accessing the docket or go to the Docket Operations in Room W12-140
of the West Building Ground Floor at 1200 New Jersey Avenue SE,
Washington, DC 20590-0001, between 9 a.m. and 5 p.m., Monday through
Friday, except Federal holidays.

FOR FURTHER INFORMATION CONTACT: Nia Daniels,<PHONE_NUMBER>, Office of
Rulemaking, Federal Aviation Administration, 800 Independence Avenue
SW, Washington, DC 20591.
    This notice is published pursuant to 14 CFR 11.85.

    Issued in Washington, DC.
Timothy R. Adams,
Deputy Executive Director, Office of Rulemaking.

Petition for Exemption

    Docket No.: FAA-2021-0079.
    Petitioner: Airlines for America.
    Section of 14 CFR Affected: 121.463(c).
    Description of Relief Sought: Airlines for America (A4A), on behalf
of its member airlines, petitions for relief from Sec.  121.463(c). The
relief, if granted, would suspend the requirement for aircraft
dispatcher operating familiarization flights until March 31, 2022. The
petition seeks to allow dispatchers who have completed operating
familiarization flights in previous years to remain qualified without
exposing them and flight crew members to an increased risk for exposure
to COVID-19.

[FR Doc. 2021-05432 Filed 3-15-21; 8:45 am]
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