UNITED STATES ENVIRONMENTAL PROTECTION AGENCY Office of Air Quality Planning and Standards Research Triangle Park, North Carolina 27711 August 29, 2003 MEMORANDUM SUBJECT: Analyses of 2000 2002 PM Data for the PM NAAQS Review FROM: Mark Schmidt, OAQPS David Mintz, OAQPS Tesh Rao, OAQPS Lance McCluney, OAQPS ( Intern)

TO: file The purpose of this memorandum is to describe and summarize multiple sets of analyses conducted for the review of the Particulate Matter ( PM) national ambient air quality standards ( NAAQS). Both PM10 and PM2.5 data were analyzed, as well as the calculated differences of the two particle size cuts ( PM10 2.5), and PM2.5 composition data. Most PM10 and PM2.5 data, and corresponding meteorological information, were extracted from EPA's Air Quality System ( AQS) data base on various dates in May, 2003. PM2.5 composition data from urban sites in the EPA Speciation Network ( ESpN) were pulled from AQS in July, 2003. PM mass and PM2.5 composition data from rural sites in the Interagency Monitoring of PROtected Visual Environmental ( IMPROVE) aerosol monitoring network were acquired from the National Park Service in July, 2003. Additional meteorological data were obtained from the National Weather Service. Meteorological data were necessary to convert AQS PM10 samples reported at ` standard conditions' ( 25 ° C, 760 mm Hg) to ` local conditions' ( actual temperature and pressure). The conversion was necessary to facilitate size cut comparisons of PM10 to PM2.5 and calculate an accurate difference; PM10 data are generally reported to AQS at standard conditions and PM2.5 data are reported at local conditions. There are three attachments to this memo, each corresponding to the different type of data analyzed: Attachment A describes the AQS based, 24 hour duration analyses; Attachment B describes the AQS based hourly analyses; and Attachment C describes the ESpN and IMPROVE data analyses. Each attachment contains a discussion of the methods and assumptions used to generate results. All AQS based 24 hour duration PM ( 10 and 2.5 micron size cuts) data and hourly PM10 data used in the analyses were sampled with Federal Reference Methods ( FRM) or Federal Equivalent Methods ( FEM). Hourly AQS PM2.5 data and particle data collected in the ESpN and IMPROVE networks ( Attachment C) utilized non FRM/ FEM techniques.

States are required to certify their data submitted to AQS on an annual basis for each calender year; this certification must be done by July 1st of the following year. Since the 2002 data used for these analyses were queried from AQS prior to the certification deadline, it should Page  2 be noted that the 2002 data are subject to change and that additional 2002 data may have been reported after the retrievals used in these analyses.

Some analysis results are summarized at a broad regional level using the geographic regions specified below. The regional definitions correspond to the regions identified by the Health Effects Institute ( HEI) in a recent PM study. [ See Figure 1, page 8, in Samet, J. M., et al., " The National Morbidity, Mortality, and Air Pollution Study Part II: Morbidity, Mortality, and Air Pollution in the United States," Health Effects Institute, Research Report Number 94, Part II, June 2000.] The origin of the HEI region definitions can be traced back to Figure 6 30 of EPA's 1996 PM Criteria Document, which identified regions on the basis of " uniqueness in aerosol trends, seasonality, size distribution, or chemical composition." Some sites ( e. g., ones in Alaska, Hawaii, Puerto Rico, and the Virgin Islands, ) were not assigned to an HEI region. For these analyses, these sites were placed in Region 0, ` Not in PM Region'. Data for these sites are excluded from charts shown ` by region' but are included elsewhere.

PM REGION CODE PM REGION DESCRIPTION HOW DEFINED 1 Northeast ME, NH, VT, MA, RI, CT, NJ, DE, MD*, PA*, NY*, VA*, WV* (* east of  78.50 ° W longitude)

2 Southeast NC, SC, TN, GA, FL, AL, MS, LA, AR, OK*, TX* (* east of  97.70 ° W longitude)

3 Industrial Midwest NY*, PA*, WV*, VA*, KY, OH, MI, IN, IL, WI#, MN#, IA#, MO# (* west of  78.50 ° W longitude, # east of  91.50 ° W longitude)

4 Upper Midwest MN*, WI*, IA*, MO*, ND, SD, NE, KS, CO# (* west of  91.50 ° W longitude, # east of  104.05 ° W longitude)

5 Southwest OK*, TX*, NM, AZ, NV#, CA# (* west of  97.70 ° W longitude, # south of 37.00 ° N latitude and east of  115.50 ° W longitude)

6 Northwest WA, ID, MT, WY, UT, OR, CO*, CA#, NV# (* west of  104.05 ° W longitude, # north of 37.00 ° N latitude)

7 Southern California CA*, NV* (* west of  115.50 ° W longitude and south of 37.00 ° N latitude)

For additional information on the analyses documented in the attachments, please contact Mark Schmidt at ( 919) 541 2416.

3 Attachments Page  A1 ATTACHMENT A Processing Details for AQS 24 hour Sample Duration Files and Figures This attachment describes the data ( 2000 2002) and processing procedures used to generate the following AQS based, 24 hour sample duration files and figures: C File PM25_ sitemon_ info. xls: PM2.5 Site Monitor Information C File PM10_ sitemon_ info. xls: PM10 Site Monitor Information C File PMC_ sitemon_ info. xls: PM10 2.5 Site Monitor Information C File PM25_ sitemon_ summary. xls: PM2.5 Monitor Data Summary C File PM10_ sitemon_ summary. xls: PM10 Monitor Data Summary C File PMC_ sitemon_ summary. xls: PM10 2.5 Monitor Data Summary C File PM25ctymax. xls: PM2.5 County Max Data Summary C File PM10ctymax. xls: PM10 County Max Data Summary C File PMCctymax. xls: PM10 2.5 County Max Data Summary C Figure 2 4. Distribution of annual mean PM2.5 and estimated annual mean PM10 2.5 concentrations by region, 2000 2002. C Figure 2 5. Distribution of 98th percentile 24 hour average PM2.5 and estimated PM10 2.5 concentrations by region, 2000 2002. C Figure 2 6. County level maximum annual mean PM2.5 concentrations, 2000 2002. C Figure 2 7. County level maximum 98th percentile 24 hour average PM2.5 concentrations, 2000 2002. C Figure 2 9. County level maximum annual mean PM10 concentrations, 2000 2002. C Figure 2 10. County level maximum 98th percentile 24 hour average PM10 concentrations, 2000 2002. C Figure 2 11. Estimated county level maximum annual mean PM10 2.5 concentrations, 2000 2002. C Figure 2 12. Estimated county level maximum 98th percentile 24 hour average PM10 2.5 concentrations, 2000 2002. C Figure 2 16. Distribution of ratios of annual mean PM2.5 to PM10 by region, 2000 2002. C Figure 2 17. Regional average correlation of 24 hour average PM by size fraction. C Figure 2 18. Urban 24 hour average PM2.5 concentration distributions by region and month, 2000 2002. C Figure 2 19. Urban 24 hour average PM10 2.5 concentration distributions by region and month, 2000 2002. CC Figure 2 20. Distribution of annual mean vs. 98th percentile 24 hour average PM2.5 concentrations, 2000 2002. C Figure 2 21. Distribution of estimated annual mean vs. 98th percentile 24 hour average PM10 2.5 concentrations, 2000 2002.

General Data Description All data, except for supplemental meteorological data obtained from NWS, were extracted from EPA's Air Quality System database ( AQS). After downloading and necessary preprocessing, data for PM10, PM2.5, and calculated PM10 2.5, sites were subjected to data completeness criteria. The data selection criteria for all PM size cuts ( applied independently to PM10, PM2.5, and calculated PM10 2.5) was ( by site) the most recent 4, 8, or 12 consecutive quarters of 11 or more samples. A simple example is shown below. For this example site, the quarters that would have been utilized are shaded. Since the selection criterion evaluates available data in increments of 4 quarters, previous quarters could not be used due to the shortfall in 2001, quarter 1. An additional increment of 4 consecutive quarters meets the 11 minimum sample threshold ( 1999, quarters 1 4), but would not have been used since the more recent band of data ( shaded) were available. Although the utilized selection criteria do not guarantee a calendar year( s) of data, it does provide at least one full year consisting of four quarters, thus reducing seasonal bias. Data present in quarters not part of the 4, 8, or 12 quarter period of interest were deleted and thus, not included in a site summaries ` 00 Q1 ` 00 Q2 ` 00 Q3 ` 00 Q4 ` 01 Q1 ` 01 Q2 ` 01 Q3 ` 00 Q4 ` 00 Q4 ` 02 Q1 ` 02 Q3 ` 02 Q4 N= 12 13 14 15 10 15 16 14 15 13 11 9 Page  A2 Means and percentiles were calculated for each site that met completeness criteria. Weighted ` annual' means ( referenced as ` ANNMEAN' in summary data files) were computed for each site as follows: quarterly averages were calculated for each kept quarter; 4 quarter averages were then computed from the applicable one, two, or three sets of quarterly averages ( e. g., in the example above, from the ` 00 Q4, ` 01 Q1, ` 01 Q2, and ` 01 Q3 averages); then, the 4 quarter means were averaged together. Percentiles of interest ( minimum, maximum, median, 5th, 25th, 75th, and 95th) were computed on the entire 4, 8, or 12 quarter distribution of data.

Although all data submitted to AQS are considered valid, some data are tagged with quality assurance qualifiers, natural event flags, and/ or exceptional event flags. All data, regardless of flags, were included in these analyses.

All concentrations presented in the analyses outputs are shown in units of micrograms per cubic meter ( µ g/ m3) at local conditions. Since most regulatory PM10 data are reported in units of µ g/ m3 at standard temperature and pressure conditions ( 25 ° C, 760 mm Hg), the data had to be converted to local temperature and pressure conditions using meteorological information ( see next section). The standard conditions PM10 data were converted to local conditions before the site completeness criteria ( most recent 4, 8, or 12 consecutive quarters of 11+ samples) were applied.

PM10 Data PM10 data from Federal Reference Methods ( FRM) and Federal Equivalent Methods ( FEM) monitors were extracted from AQS on May 28, 2003. Four separate queries were made: 1) raw daily ( 24 hour) for parameter 81102 [ PM10, standard temperature and pressure conditions ( STP)]; 2) raw daily for parameter 85101 [ PM10, local temperature and pressure conditions ( LTP)]; 3) summary daily ( hourly reported measurements aggregated within AQS to a 24 hour period) for parameter 81102; and 4) summary daily for parameter 85101. The ` daily' monitors collected 24 hour average samples on a filter for each successful day of monitoring. The monitors are typically scheduled to collect PM10 samples once every 6 days, though some collected samples more frequently. The PM10 filter samples are weighed in a laboratory environment to obtain mass concentrations expressed in micrograms per cubic meter ( µ g/ m3). The ` hourly' monitors are generally operated continuously almost every hour of the year ( with occasional down time for calibrations and audits). AQS maintains the raw hourly data and also aggregates the hourly information into summary daily records. A summary record is only created if 75% or more of the hourly data ($ 16) are present.

Parameter 81102 data, both summary and daily, were converted to local conditions using collocated temperature and pressure information. If collocated temperature and/ or pressure data were not available, meteorological data from the nearest NWS station were used. If collocated data were not available and the NWS data were missing, the STP data were not converted to LTP and not used in the analyses. Parameter 85101 and converted 81102 data were merged by site day. If more than one type of PM10 data were present on a given day, LTP reported data were favored over converted ( STP to LTP) data, and lower Pollutant Occurrence Codes ( POC's) were favored over higher POC numbers. Typically, monitors with lower POC numbers will have more data ( sample more frequently) than monitors with higher POC numbers ( for the same duration data). ` Primary' sampler POC numbers are generally lower than quality assurance ( QA) monitor POC's; thus primary data were favored over QA data. Daily sampling monitors Page  A3 also usually have lower POC numbers than hourly sampling instruments, so the daily data were generally selected over the summary daily data. Hence, the following selection priority was implemented: 85101 daily > 85101 summary > 81102 daily > 81102 hourly.

Site data were evaluated on the 11 sample per quarter threshold and a determination made as to which 4, 8, or 12 ( all) quarters to keep. 1235 sites had at least 4 consecutive quarters of 11+ samples: 707 sites had 12 quarters available, 246 sites had 8 quarters available, and 282 sites had 4 quarters to use. The 1235 sites are mapped in Figure B 1. Metadata for the 1235 sites are provided in file, ` PM10_ sitemon_ info. xls'. Summary data for the sites ( means and moments) are provided in file, ` PM10_ sitemon_ summary. xls'. County maxima of site ` ANNMEAN' and 98th percentile are provided in ` PM10ctymax. xls'.

PM2.5 Data PM2.5 data from non continuous FRM monitors were extracted from AQS on May 28, 2003. Only one AQS query was necessary: 24 hour ( daily) data for parameter 88101 ( PM2.5, local temperature and pressure conditions). Hourly data were not extracted for these analyses since are there are no continuous FRM/ FEM methods for PM2.5. PM2.5 monitors are typically scheduled to collect PM2.5 samples once every 3 days, though some collected samples more or less frequently. The PM2.5 filter samples are weighed in a laboratory environment to obtain mass concentrations ( µ g/ m3). PM2.5 data, reported as parameter 88101, are in local conditions. Only primary monitors were used in the analyses; primary monitors are the first occurring POC, generally ` 1'. Site data were evaluated on the 11 sample per quarter threshold and a determination made as to which 4, 8, or 12 ( all) quarters to keep. 1152 sites had at least 4 consecutive quarters of 11+ samples: 789 sites had all 12 quarters available, 193 sites had 8 quarters available, and 170 sites had 4 quarters to use. The 1152 sites are mapped in ` pm25 map. gif'. Metadata for the 1152 sites are provided in file, ` PM25_ sitemon_ info. xls'. Summary data for the sites ( means and moments) are provided in file, ` PM25_ sitemon_ summary. xls'. County maxima ( of site ` ANNMEAN' and 98th percentile) are provided in ` PM25ctymax. xls'.

PM( 10 2.5) Estimates In order to characterize a PM coarse fraction ( i. e., PM less than 10 micrometers but greater than 2.5 micrometers), a simplistic difference method was utilized. At locations where both PM10 and PM2.5 were recorded, PM2.5 daily averages are subtracted from PM10 daily averages. Currently there are no federal PM coarse fraction monitoring requirements. Although there are no federal reference or equivalent methods stipulated for the PM coarse fraction, only FRM/ FEM PM10 and PM2.5 daily averages were used to construct the PM10 2.5 estimates. No effort was made to account for differences in sampling instruments or protocols between the colocated PM10 and PM2.5 monitors. Because of these differences ( and other factors), occasionally the calculated PM10 2.5 values were negative; this is not unexpected for two independent observations and negative PM10 2.5 concentrations were not censored from the analyses. Both the PM10 and PM2.5 data used in the difference calculation were in units of µ g/ m3 at local conditions, thus the calculated PM10 2.5 values also are in those units. All available FRM/ FEM PM10 and PM2.5 data were used to construct the PM10 2.5 estimates; the completeness criteria ( most recent 4, 8, or 12 consecutive quarters of 11+ samples) were evaluated after the daily difference estimates were calculated. 488 sites met the completeness criteria of at least 4 consecutive quarters of 11+ Page  A4 samples; 219 sites had 12 quarters available, 129 sites had 8 quarters available, and 140 sites had 4 quarters to use. The 488 sites are mapped in Figure B 3. Metadata for the 488 sites are provided in file, ` PMC_ sitemon_ info. xls'. Summary data for the sites ( means and moments) are provided in file, ` PMC_ sitemon_ summary. xls'. County maxima ( of site ` ANNMEAN' and 98th percentile) are provided in ` PMCctymax. xls'.

Boxplot Figures Many of the analyses figures are boxplots. Unless otherwise noted, in all of the AQSbased 24 hour average duration boxplots, the following definitions apply: C The bottom of the box depicts the 25th percentile of the plotted distribution C The top of the box depicts the 75th percentile of the plotted distribution C The line through the box identifies the distribution median C The top whisker cap identifies the 95th percentile of the plotted distribution C The bottom whisker cap identifies the 5th percentile of the plotted distribution C The distribution maximum and minimum are shown as asterisks Data Files and Processing Code The graphics generated for the PM NAAQS review and the 3 size faction site maps are included in the attached file, ` Attach A Graphics'.

The nine Microsoft Excel spreadsheets mentioned above are contained in the attached file, ` Attach B spreadsheets. zip' along with a data dictionary. A spreadsheet of boxplot plotting points is also included.

Raw, intermediate, and final SAS data files generated for these analyses are included in the attached file, ` Attach B SASdata. zip':

Data were processed with SAS software. The SAS programs are included in the attached file, ` Attach B SAS. zip':

Comments on Specific Figures:

Figure 2 4. Distribution of annual mean PM2.5 and estimated annual mean PM10 2.5 concentrations by region, 2000 2002: C Shows distribution of site level ANNMEAN by size fraction and region. C Region 0 data ( 23 sites for PM2.5, 13 sites for PM10 2.5) were excluded from chart. Figure 2 5. Distribution of 98th percentile 24 hour average PM2.5 and estimated PM10 2.5 concentrations by region, 2000 2002: C Shows distribution of site level PCT98 by size fraction and region. C Region 0 data ( 23 sites for PM2.5, 13 sites for PM10 2.5) were excluded from chart. Figure 2 6. County level maximum annual mean PM2.5 concentrations, 2000 2002: C Shows county maximum of PM2.5 site mean ( referenced as ANNMEANMAX in Page  A5 PM25ctymax. xls) C Concentration ranges provided by AQSSD, HEEG. Figure 2 7. County level maximum 98th percentile 24 hour average PM2.5 concentrations, 2000 2002: C Shows county maximum of PM2.5 site 98th percentile ( referenced as PCT98MAX in PM25ctymax. xls) C Concentration ranges provided by AQSSD, HEEG. Figure 2 9. County level maximum annual mean PM10 concentrations, 2000 2002: C Shows county maximum of PM10 site mean ( referenced as ANNMEANMAX in PM10ctymax. xls) C Concentration ranges provided by AQSSD, HEEG. Figure 2 10. County level maximum 98th percentile 24 hour average PM10 concentrations, 2000 2002: C Shows county maximum of PM10 site 98th percentile ( referenced as PCT98MAX in PM10ctymax. xls) C Concentration ranges provided by AQSSD, HEEG. Figure 2 11. Estimated county level maximum annual mean PM10 2.5 concentrations, 2000 2002: C Shows county maximum of PM10 2.5 site mean ( referenced as ANNMEANMAX in PMCctymax. xls) C Concentration ranges provided by AQSSD, HEEG. Figure 2 12. Estimated county level maximum 98th percentile 24 hour average PM10 2.5 concentrations, 2000 2002: C Shows county maximum of PM10 2.5 site 98th percentile ( referenced as PCT98MAX in PMCctymax. xls) C Concentration ranges provided by AQSSD, HEEG. Figure 2 16. Distribution of ratios of 24 hour average PM2.5 to PM10 by region, 2000 2002: C The ratio of PM2.5 to PM10 was first calculated for each site day. Because the parameter selection criteria ( most recent 4, 8, or 12 consecutive quarters of 11+ samples) were applied separately for PM10 and PM2.5, the selected time periods did not necessarily match. If the common time periods of constituent raw data ( for the PM10 and PM2.5 sites that met the selection criteria) were used for this analysis, some sites common to both parameters would not have any matches ( by site day) and others would have a seasonal bias ( only have matches in certain quarters). To avoid this situation, the raw data used in this analysis were culled from the PM10 2.5 database ( pmc_ raw_ meetscomp. sas7bdat). This insured an equal number of each quarter for each site and also insured a minimum of 44 samples for each site ( 4 quarters * 11 samples each). C The site day ratios of PM2.5 to PM10 were averaged by site and the distribution of the site ratios plotted by region. Figure 2 17. Regional average correlation of 24 hour average PM by size fraction: C For the same reason noted in the first bullet above, all data used in this analysis were culled from the PM10 2.5 database ( PMC_ raw_ meetscomp. sas7bdat). C A Pearson correlation coefficient was calculated for each site fraction pair ( PM10 versus PM2.5, PM2.5 versus PM10 2.5, and PM10 versus PM10 2.5. C The site correlation coefficients for each fraction were averaged by region. C Region 0 data ( 23 sites for PM2.5, 13 sites for PM10 2.5) were excluded from the chart. Figure 2 18. Urban 24 hour average PM2.5 concentration distributions by region and month, Page  A6 2000 2002. C Only data from monitors with location setting ( referenced ` LOCATION" in ` PM25_ sitemon_ info. xls') = ` URBAN AND CENTER CITY' or ` SUBURBAN' were used. C All 24 hour average values from kept quarters at above noted monitors were averaged together by region month. C In the plots, the boxes represent the interquartile range ( 25th to 75th percentiles) of each monthly distribution and the line inside the box is the median of the distribution. The trend line represents the mean, and the number above each box represents the number of 24 hour average observations that were used to generate each box plot. C Only valid regions ( 1 7) were plotted. ° Seven separate graphics were produced for the PM NAAQS review memo; a 2 character HEI region name abreviation differentiates the attached plots. Figure 2 19. Urban 24 hour average PM10 2.5 concentration distributions by region and month, 2000 2002. C Only data from monitors with location setting ( referenced ` LOCATION" in ` PMC_ sitemon_ info. xls') = ` URBAN AND CENTER CITY' or ` SUBURBAN' were used. C All 24 hour average values from kept quarters at above noted monitors were averaged together by region month. C In the plots, the boxes represent the interquartile range ( 25th to 75th percentiles) of each monthly distribution and the line inside the box is the median of the distribution. The trend line represents the mean, and the number above each box represents the number of 24 hour average observations that were used to generate each box plot. C Only valid regions ( 1 7) were plotted. ° Seven separate graphics were produced for the PM NAAQS review memo; a 2 character HEI region name abbreviation differentiates the attached plots. Figure 2 20. Distribution of annual mean vs. 98th percentile 24 hour average PM2.5 concentrations, 2000 2002: C Shows distribution of site level 98th percentile by annual mean range. C Concentration ranges provided by AQSSD, HEEG. Figure 2 21. Distribution of estimated annual mean vs. 98th percentile 24 hour average PM10 2.5 concentrations, 2000 2002: C Shows distribution of site level 98th percentile by annual mean range. C Concentration ranges provided by AQSSD, HEEG. Page  B1 ATTACHMENT B Processing Details for AQS Hourly Sample Duration Figures This attachment describes the data ( 2000 2002) and processing procedures used to generate the following AQS based, hourly sample duration figures: C Figure 2 22. Hourly average PM2.5 distributions ( upper panel) and seasonal average PM2.5 concentrations ( lower panel) at a Cleveland, OH monitoring site, 2000 2002. C Figure 2 23. Hourly average PM10 2.5 distributions at a Cleveland, OH monitoring site, 2000 2002. The graphics are included in the attached file, ` Attach B graphics'.

Data Description Hourly ( AQS duration=' 1') PM10 and PM2.5 data for calendar years 2000 2002 were extracted from AQS on May 28, 2003. Two queries were made for PM10: one for parameter 81102 [ PM10, standard temperature and pressure conditions ( STP)] and one for parameter 85101 [ PM10, local temperature and pressure conditions ( LTP)]. Only one query was necessary for PM2.5, for parameter 88101 ( PM2.5 LTP). Hourly meteorological data were obtained from the National Weather Service ( NWS). Meteorological data, specifically temperature and pressure, were necessary to convert PM10 data reported at STP to LTP. To convert the PM10 STP data to an LTP basis, the following formula was used:

PM10 LTP= PM10 STP * [ 298 / temperature ( degrees C)] * [ pressure ( mm Hg) / 760].

Hourly PM10 2.5 records were created by subtracting the PM2.5 from the LTP ( reported or converted) PM10 values. Since data are reported to AQS in Standard Time, hours were adjusted to reflect daylight savings time to be consistent with human activity. The seasons were derived in the following manner: ° December, January, February ( quarter 1) = Winter ° March, April, May ( quarter 2) = Spring ° June, July, August ( quarter 3) = Summer ° September, October, November ( quarter 4) = Fall Outputs Description Two types of plots are shown in the analyses figures, boxplots and a diurnal line plots. In the boxplots, the boxes represent the interquartile range ( 25th to 75th percentiles) of each hourly distribution, the line inside each box shows the median of the distribution, the dot inside each box represents the distribution mean ( the distribution means are connected by lines), and the box whiskers represent the 5th and 95th percentiles. The diurnal line graph plots hourly averages by season. The hourly averages ( by season) are joined by lines; plotting symbols are not shown. Although the outputs were produced for multiple sites, only the graphics for the Cleveland, OH Page  B2 site ( AQS ID = 390350060) were used in the analyses memorandum.

Methodology The statistical software package SAS was used to process the data and create the associated graphics. The SAS procedure PROC UNIVARIATE was used to calculate the summary statistics and the procedure PROC GPLOT was used to procedure the graphics. The code used to generate the plots are contained in Attach B SAScode. Page  C1 ATTACHMENT C Processing Details for IMPROVE and ESpN Figures This attachment describes the data and processing procedures used to generate the following ESpN and IMPROVE figures: C Figure 2 8. Average annual mean PM2.5 concentration trend at IMPROVE sites, 1999 2001. C Figure 2 13. Average annual mean PM10 2.5 concentration trend at IMPROVE sites, 1999 2001. C Figure 2 14. Annual average composition of PM2.5 by Region. Upper panel rural sites, lower panel urban sites. C Figure 2 15. Average annual mean sulfate, total carbon, and crustal material concentration trend at IMPROVE sites, 1999 2001. The graphics are included in the attached file, ` Attach C Graphics'.

Data Description Two types of data were used in these analyses: Rural particle data were derived from daily measurements from the Interagency Monitoring of PROtected Visual Environmental ( IMPROVE) aerosol monitoring network. Urban aerosol particle data were derived from daily measurements from the EPA Speciation Monitoring Network ( ESpN). Data from ESpN were extracted from AQS on July 3, 2003. Data from IMPROVE were obtained in two manners. Debbie Miller of the National Park Service provided 1992 2001 site level annual summary data on July 10, 2003. Additional IMPROVE summary data for the time period September, 2001 through August, 2002 were downloaded from the IMPROVE website on July 20, 2003. All summary data used in these analyses are included in the attached file, ` Attach C Data'.

The IMPROVE trends analyses ( Figures 2 8, 2 13 and 2 15) show 10 year trends for PM10 2.5 mass; PM2.5 mass; and the three PM2.5 mass components: sulfate ( SO4), total carbon ( TC, sum of organic carbon and elemental carbon), and crustal material. All five major components of PM2.5 mass are reported in the IMPROVE / ESpN bar graphs of Figure 2 14. These components include: ammonium ( NH4), nitrate ( NO3), total carbonaceous mass ( TCM), and crustal material. TCM is calculated as organic carbon mass ( OCM) + elemental carbon ( EC). OCM is estimated as measured and blank corrected organic carbon ( OC) multiplied by 1.40 ( to convert to mass). Crustal material concentrations are estimated using the ` IMPROVE equation: 2.2[ Aluminum]+ 2.49[ Silicon]+ 1.63[ Calcium]+ 2.42[ Iron]+ 1.94[ Titanium].

Outputs Description The IMPROVE trends plots ( Figures 2 8, 2 13 and 2 15) show the annual average concentrations for PM10 2.5, PM2.5, sulfate, total carbon, and crustal material averaged across 9 eastern sites and 23 western sites. There is also a separate plot series for the Washington, DC site because it is not a rural site like the others. A list of sites by area classification is provided in the file ` Trends Region X Site. xls' ( which is located in ` Attach C Data. zip'.) Page  C2 The bar graphs contrast rural ( top panel, data from IMPROVE) versus urban ( bottom panel, data from ESpN) average concentrations of PM2.5 constituents by geographic region. For this particular analysis, the following geographic regions were used ( in lieu of HEI region definitions): South East, Mid West, East Coast/ North East, East Texas/ South, Far North East, North Plains, California, Desert West, and North West. See spreadsheet ` Bar Charts Region X Site. xls' ( located in ` Attach C data. zip') for the regional site assignments.

Methodology For the trends analyses, sites were required to have 8 of 10 valid years of data. Missing years were interpolated using surrounding years. The lines plotted are the averages across the trend sites in each region. The Washington plot is based on a single site. PROC UNIVARIATE in the SAS statistical software package was used to calculate the averages in each plot. The SAS code is included in the attached file, ` Attach C SAScode'. Plotting points for each of the three plots are presented in file, ` Trends Plotting Points. xls' which is located in ` Attach C Data. zip'.

For the bar graphs, only data for ` complete' sites were used. For both the urban and rural data, ` complete' data consisted of having 50% or more observations ( of the major chemical components of PM2.5 mass: sulfate, nitrate, organic carbon mass, elemental carbon, aluminum, calcium, titanium, iron, and silicon) per quarter for the year analyzed Use of Outputs The data as presented in the bar charts should be used only to gauge relative levels of urban versus rural concentrations of the chemical species in each of the regions. Because urban and rural sites were not specifically matched ( in terms of separation distance, representative upwind locations, etc.), no inferences should be drawn about ` urban increments' based on these data and graphics. The two bar charts simply illustrate how PM2.5 constituents vary for a group of urban and rural sites that are roughly located in the same geographic region. For further details on ` urban increment' analyses, refer to: V. Rao, N. Frank, A. Rush, F. Dimmick, " Chemical Speciation of PM2.5 in Urban and Rural Areas", In the Proceedings of the Air & Waste Management Association Symposium on Air Quality Measurement Methods and Technology, San Francisco, November 13 15, 2002.


                    User Guide to the Online Docket for the
      NPDES Electronic Reporting Rule  -  Phase 2 Extension (Final Rule)

                                                          Date: 2 November 2020
                                                                       DCN 0022
                                        EPA Docket Number EPA-HQ-OECA-2019-0408
                                       Available at: http://www.regulations.gov

1.0	OVERVIEW

      EPA published the National Pollutant Discharge Elimination System (NPDES) Electronic Reporting Rule ("NPDES eRule") on 22 October 2015. The 2015 rule required EPA and states to modernize Clean Water Act (CWA) reporting for municipalities, industries and other facilities. The rule divided implementation into two "Phases." The deadline for Phase 1 implementation passed on December 21, 2016. EPA originally set the Phase 2 deadline on December 21, 2020. Some state authorized NPDES programs provided feedback to EPA on how to improve Phase 2 implementation of the NPDES eRule and, in particular, recommended changes to the schedule for Phase 2 implementation to allow both EPA and states sufficient time to develop and implement the information technology solutions necessary for electronic reporting of the Phase 2 data.

      EPA published a proposed rule to solicit comment on changing the compliance deadlines for Phase 2 implementation as well as other changes to the NPDES eRule to allow for a smoother transition from paper to electronic reporting for the NPDES program (see February 28, 2020; 85 FR 11909). The due date for comments was April 28, 2020. EPA received comments from seven states, one state association, and one anonymous commenter.

      The final rule addresses these comments and postpones the Phase 2 implementation period for the NPDES eRule. This final regulation also provides states with additional flexibility to request additional time as needed. Further, this notice finalizes clarifying changes to the NPDES eRule and eliminates some duplicative or outdated reporting requirements. Taken together, these data standardizations and the corresponding electronic reporting requirements are designed to save the NPDES authorized programs considerable resources, make reporting easier for NPDES-regulated entities, streamline permit renewals (as permit writers typically review previous noncompliance events during permit renewal), ensure full exchange of NPDES program data between states and EPA to the public, improve environmental decision-making, and protect human health and the environment.

2.0	ACCESSING INFORMATION IN THE DOCKET

How do I Find Documents in the Docket?

      EPA Docket ID No. EPA-HQ-OECA-2019-0408 is the official docket for EPA's NPDES Electronic Reporting Rule  -  Phase 2 Extension rulemaking. The official docket consists of the documents specifically referenced in the Federal Register notices of these actions, any public comments received, and other related information.

      Regulations.gov provides online access to all of items in the docket for the NPDES Electronic Reporting Rule  -  Phase 2 Extension rulemaking. You can use the Regulations.gov to search for documents using all or a portion of the document title or its full Regulations.gov Document ID Number. For example, from the main Regulations.gov webpage you can key in "EPA-HQ-OECA-2019-0408-0001" in main search field on Regulations.gov (see Figure 1) to retrieve the proposed rule: "National Pollutant Discharge Elimination System (NPDES) Electronic Reporting Rule: Phase 2 Extension."

Figure 1: Screenshot of Regulations.gov Website (https://www.regulations.gov/)

      You can also use "Advanced Search" on Regulations.gov and a Document Control Number (DCN) to retrieve a particular document. EPA uses the DCN in the preambles to the proposed and final rules and other supporting documents to individually identify documents in the docket. The following figures show how you can use the "Advanced Search" on Regulations.gov and a DCN to retrieve a particular document from the rulemaking docket.

    Figure 2: Location of "Advanced Search" on Regulations.gov Website

          Figure 3: DCN Identifier Input Location on Advanced Search

Figure 4: Input Docket Number in "By Docket ID" Input Field on Advanced Search

                  Figure 5: Search results for "DCN 0005"

      If you are having trouble locating EPA docket materials, contact the EPA Reading Room Staff for assistance by calling<PHONE_NUMBER>, or send a message to Dockets Customer Service (Docket-customerservice@epa.gov).

NPDES Electronic Reporting Rule  -  Phase 2 Extension Docket Index

      This user guide provides a listing of the documents in docket EPA-HQ-OECA-2019-0408 (see Attachment 1). Most documents in the docket have two document identification numbers. One is the Regulations.gov Document ID Number (e.g., EPA-HQ-OECA-2019-0408-0006) that was assigned when EPA added the document to the public version of the docket at Regulations.gov. The second is the document control number (DCN) that was assigned during the development of the regulation (e.g., DCN 0005). EPA uses the DCN identifier in the preambles to the proposed and final rules and other supporting documents during development of the rulemaking. The DCN appears at the end of the document titles in the Document Title field listed in Regulations.gov.

      Public Submissions (comments) that are submitted directly to the docket by the public do not have DCNs but do have Regulations.gov Document ID Numbers and are part of the official docket. You can use "Advanced Search" on Regulations.gov to find these documents by selecting "Public Submission" (see Figure 6) and by inputing the Docket ID (EPA-HQ-OECA-2019-0408) (see Figure 4).

      Figure 6: Selection of "Public Submission" on Advanced Search to View Public Comments on the Rulemaking (Note: Must also input Docket ID  -  See Figure 4)

Table 1: Metadata for NPDES Electronic Reporting Rule  -  Phase 2 Extension Docket Index

Field Name
Description

DCN

Unique document control number (DCN) assigned during the development of the document. This number is included in the title of the document in this docket. Public comments and Federal Register notices do not have a DCN.
Document Title
This is the title of document with the DCN number.
Author
This is the author of document (Last name, first full name or organization).

Author Date

Date of publication, issue, edition, or version. Actual date of meeting or telephone call.
Source Citation
For copyright protected documents, this is a bibliographic citation (without title or author) that you can use to find the document in a library. For materials retrieved from the Internet, "Source Citation" lists the URL.
Preamble?
This field is marked with "Yes" for materials that are referenced in the preambles to the proposed or final rules.

Copyrighted (C)
This field is marked with "Yes" for materials that are copyright protected (e.g., books and other published material).
Regulations.gov Document ID #
Unique document number assigned when EPA added the document to the official docket. The Document ID Number includes the Docket Number followed by a consecutive document number.

 Further Information

      For more information on the NPDES Electronic Reporting Rule  -  Phase 2 Extension rule, please contact:

      Mr. Carey A. Johnston, P.E.
	U.S. EPA Office of Compliance, Enforcement Targeting and Data Division (2222A)
	1200 Pennsylvania Avenue NW
	Washington, DC 20460
<PHONE_NUMBER> (telephone)
<EMAIL_ADDRESS>(e-mail  -  preferred)

                                      DCN
Document Title
                                    Author
                                  Author Date
                                Source Citation
                                  Pre-amble?
                                      (C)
                         Regulations.gov Document ID #
                                      N/A
National Pollutant Discharge Elimination System (NPDES) Electronic Reporting Rule: Phase 2 Extension
                                   U.S. EPA
                                  02/28/2020
                   Federal Register Notice  -  Proposed Rule
                                      N/A
                                      No
                          EPA-HQ-OECA-2019-0408-0001
                                   DCN 0001
ACWA Letter to Assistant Administrator Susan Bodine, Office of Enforcement and Compliance Assurance, U.S. EPA [DCN 0001]
        Allison Woodall, President, Association of Clean Water Agencies
                                  07/02/2019
                               Letter to Docket
                                      Yes
                                      No
                          EPA-HQ-OECA-2019-0408-0002
                                   DCN 0002
State Letter to Assistant Administrator Susan Bodine, Office of Enforcement and Compliance Assurance, U.S. EPA [DCN 0002]
                          Lance R. LeFleur, Director
Alabama Department of Environmental Management and Directors from Georgia, Mississippi, South Carolina, and Tennessee
                                  06/06/2019
                               Letter to Docket
                                      Yes
                                      No
                          EPA-HQ-OECA-2019-0408-0003
                                   DCN 0003
EPA Response to ACWA [DCN 0003]
    Susan Bodine, Office of Enforcement and Compliance Assurance, U.S. EPA
                                  08/22/2019
                               Letter to Docket
                                      Yes
                                      No
                          EPA-HQ-OECA-2019-0408-0004
                                   DCN 0004
EPA Response to Alabama Department of Environmental Management [DCN 0004]
    Susan Bodine, Office of Enforcement and Compliance Assurance, U.S. EPA
                                  08/22/2019
                               Letter to Docket
                                      Yes
                                      No
                          EPA-HQ-OECA-2019-0408-0005
                                   DCN 0005
EPA Response to Georgia Environmental Protection Division [DCN 0005]
    Susan Bodine, Office of Enforcement and Compliance Assurance, U.S. EPA
                                  08/22/2019
                               Letter to Docket
                                      Yes
                                      No
                          EPA-HQ-OECA-2019-0408-0006
                                   DCN 0006
EPA Response to Mississippi Department of Environmental Quality [DCN 0006]
    Susan Bodine, Office of Enforcement and Compliance Assurance, U.S. EPA
                                  08/22/2019
                               Letter to Docket
                                      Yes
                                      No
                          EPA-HQ-OECA-2019-0408-0007
                                   DCN 0007
EPA Response to South Carolina Department of Health & Environmental Control [DCN 0007]
    Susan Bodine, Office of Enforcement and Compliance Assurance, U.S. EPA
                                  08/22/2019
                               Letter to Docket
                                      Yes
                                      No
                          EPA-HQ-OECA-2019-0408-0008
                                   DCN 0008
EPA Response to Tennessee Department of Environment and Conservation [DCN 0008]
    Susan Bodine, Office of Enforcement and Compliance Assurance, U.S. EPA
                                  08/22/2019
                               Letter to Docket
                                      Yes
                                      No
                          EPA-HQ-OECA-2019-0408-0009
                                   DCN 0009
Environmental Council of the States Resolution, "Towards a More Effective and Efficient Clean Water Act National Pollutant Discharge Elimination System (NPDES) Program [DCN 0009]
                                 Certified by
                                 Donald Welsh
                           Executive Director, ECOS
                                  09/26/2019
                           ECOS Resolution to Docket
                                      Yes
                                      No
                          EPA-HQ-OECA-2019-0408-0010
                                   DCN 0010
Notes from State Outreach Meeting (29 October 2019) [DCN 0010]
               Carey A. Johnston, Office of Compliance, U.S. EPA
                                  10/30/2019
                             Memorandum to Docket
                                      No
                                      No
                          EPA-HQ-OECA-2019-0408-0011
                                   DCN 0011
Notes from State Outreach Meeting (5 November 2019) [DCN 0011]
               Carey A. Johnston, Office of Compliance, U.S. EPA
                                  11/13/2019
                             Memorandum to Docket
                                      No
                                      No
                          EPA-HQ-OECA-2019-0408-0012
                                   DCN 0012
Assessment of NPDES Electronic Reporting Participation Rates  -  2017 [DCN 0012]
               Carey A. Johnston, Office of Compliance, U.S. EPA
                                  08/07/2017
                              Memorandum to File
                                      Yes
                                      No
                          EPA-HQ-OECA-2019-0408-0013
                                   DCN 0013
Assessment of NPDES Electronic Reporting Participation Rates  -  2018 [DCN 0013]
               Carey A. Johnston, Office of Compliance, U.S. EPA
                                  07/06/2018
                              Memorandum to File
                                      Yes
                                      No
                          EPA-HQ-OECA-2019-0408-0014
                                   DCN 0014
Assessment of NPDES Electronic Reporting Participation Rates  -  2019 [DCN 0014]
               Carey A. Johnston, Office of Compliance, U.S. EPA
                                  09/16/2019
                              Memorandum to File
                                      Yes
                                      No
                          EPA-HQ-OECA-2019-0408-0015
                                   DCN 0015
Summary of EPA's NPDES eRule Phase 2 NeT Development for General Permits and Program Reports  -  Spreadsheet [DCN 0015]
                                   U.S. EPA
                                   1/14/2020
                             Spreadsheet to Docket
                                      Yes
                                      No
                          EPA-HQ-OECA-2019-0408-0016
                                   DCN 0016
Supporting Statement for Information Collection Request (ICR) for the NPDES Electronic Reporting Rule  -  Phase 2 Extension (Proposal) [DCN 0016]
                                   U.S. EPA
                                    02/2020
                               Record to Docket
                                      Yes
                                      No
                          EPA-HQ-OECA-2019-0408-0020
                                   DCN 0017
EPA NPDES eRule Phase 2 Implementation: Roadmap for Deploying Phase 2 NeT Applications [DCN 0017]
                                   U.S. EPA
                                    02/2020
                               Record to Docket
                                      Yes
                                      No
                          EPA-HQ-OECA-2019-0408-0019
                                   DCN 0018
NPDES Deficiencies and Violations Codes  -  Spreadsheet [DCN 0018]
                                   U.S. EPA
                                  10/11/2019
                             Spreadsheet to Docket
                                      No
                                      No
                          EPA-HQ-OECA-2019-0408-0017
                                   DCN 0019
EPA Completes Agreements to Settle Clean Water Act Violations from Biosolids Land Application in Iowa, Kansas, Missouri and Nebraska [DCN 0019]
                                   U.S. EPA
                                  12/20/2019
                                 Press Release
                                      No
                                      No
                          EPA-HQ-OECA-2019-0408-0018
                                   DCN 0020
User Guide to the Online Docket for the
NPDES Electronic Reporting Rule  -  Phase 2 Extension (Proposed Rule) [DCN 0020]
                                   U.S. EPA
                                    02/2020
                               Record to Docket
                                      No
                                      No
                          EPA-HQ-OECA-2019-0408-0021
                                      N/A
Comment submitted by Brian Weigel, Director, Watershed Management Bureau and Adrian Stocks, Director, Water Quality Bureau, Wisconsin Department of Natural Resources
                   Wisconsin Department of Natural Resources
                                  03/20/2020
                                Public Comment
                                      Yes
                                      No
                          EPA-HQ-OECA-2019-0408-0022
                                      N/A
Comment submitted by Kayla Lyon, Director, Iowa Department of Natural Resources
                     Iowa Department of Natural Resources
                                  04/27/2020
                                Public Comment
                                      Yes
                                      No
                          EPA-HQ-OECA-2019-0408-0023
                                      N/A
Comment submitted by Lynn Barlow, Community and Program Assistance Manager, Oregon Department of Environmental Quality
                  Oregon Department of Environmental Quality
                                  04/27/2020
                                Public Comment
                                      Yes
                                      No
                          EPA-HQ-OECA-2019-0408-0024
                                      N/A
Comment submitted by Patrick McDonnell, Secretary, Pennsylvania Department of Environmental Protection
              Pennsylvania Department of Environmental Protection
                                  04/28/2020
                                Public Comment
                                      Yes
                                      No
                          EPA-HQ-OECA-2019-0408-0025
                                      N/A
Comment submitted by Toby Baker, Executive Director, Texas Commission on Environmental Quality
                   Texas Commission on Environmental Quality
                                  04/28/2020
                                Public Comment
                                      Yes
                                      No
                          EPA-HQ-OECA-2019-0408-0026
                                      N/A
Comment submitted by David E. Ramsey, ICIS Program Coordinator, Arkansas Department of Energy & Environment
                Arkansas Department of Energy & Environment
                                  04/28/2020
                                Public Comment
                                      Yes
                                      No
                          EPA-HQ-OECA-2019-0408-0027
                                      N/A
Comment submitted by Melanie D. Davenport, President, Association of Clean Water Administrators
                   Association of Clean Water Administrators
                                  04/28/2020
                                Public Comment
                                      Yes
                                      No
                          EPA-HQ-OECA-2019-0408-0028
                                      N/A
Comment submitted by Jeffery W. Kitchens, Chief, Water Division, Alabama Department of Environmental Management
                Alabama Department of Environmental Management
                                  04/28/2020
                                Public Comment
                                      Yes
                                      No
                          EPA-HQ-OECA-2019-0408-0029
                                      N/A
Anonymous public comment
                                   Anonymous
                                  04/28/2020
                                Public Comment
                                      Yes
                                      No
                          EPA-HQ-OECA-2019-0408-0030
                                   DCN 0021
Comment Response Document for the NPDES Electronic Reporting Rule  -  Phase 2 Extension (Final Rule) [DCN 0021]
                                   U.S. EPA
                                   9/23/2020
                               Record to Docket
            Yes  -  See comment responses in preamble to final rule
                                      No
                          EPA-HQ-OECA-2019-0408-0039
                                   DCN 0022
User Guide to the Online Docket for the NPDES Electronic Reporting Rule  -  Phase 2 Extension (Final Rule)
                                   U.S. EPA
                                  11/02/2020
                               Record to Docket
                                      No
                                      No
                          EPA-HQ-OECA-2019-0408-0040
                                   DCN 0023
Supporting Statement for Information Collection Request (ICR) for the NPDES Electronic Reporting Rule  -  Phase 2 Extension (Final Rule) [DCN 0023]
                                   U.S. EPA
                                   9/23/2020
                               Record to Docket
                                    Yes -
                   See Section VII.C, preamble to final rule
                                      No
                          EPA-HQ-OECA-2019-0408-0038
                                   DCN 0024
Updates to NPDES eRule Data Elements to Reflect MS4 General Permit Remand Rule (Final Rule) [DCN 0024]
                                   U.S. EPA
                                  04/15/2020
                            Federal Register Notice
                                    Yes -
                    See Section II, preamble to final rule
                                      No
                          EPA-HQ-OECA-2019-0408-0032
                                   DCN 0025
Appendix A Changes Made by MS4 Remand Update Rule (15 April 2020) [DCN 0025]
                                   U.S. EPA
                                  04/15/2020
                               Record to Docket
                                    Yes -
                    See Section II, preamble to final rule
                                      No
                          EPA-HQ-OECA-2019-0408-0033
                                   DCN 0026
Notes from State Outreach Meeting with ACWA (12 May 2020) [DCN 0026]
               Carey A. Johnston, Office of Compliance, U.S. EPA
                                  06/12/2020
                               Record to Docket
                                      No
                                      No
                          EPA-HQ-OECA-2019-0408-0034
                                   DCN 0027
Notes from State Outreach Meeting with Iowa DNR (13 May 2020) [DCN 0027]
               Carey A. Johnston, Office of Compliance, U.S. EPA
                                  06/12/2020
                               Record to Docket
                                      Yes
                                      No
                          EPA-HQ-OECA-2019-0408-0035
                                   DCN 0028
The Enforcement Management System, National Pollutant Discharge Elimination System (Clean Water Act) [DCN 0028]
                                   U.S. EPA
                                     1989
https://www.epa.gov/enforcement/enforcement-management-system-national-pollutant-discharge-elimination-system-clean
                                      Yes
                                      No
                          EPA-HQ-OECA-2019-0408-0036
                                   DCN 0029
Assessment of NPDES Electronic Reporting Participation Rates  -  2020 [DCN 0029]
               Carey A. Johnston, Office of Compliance, U.S. EPA
                                  08/10/2020
                              Memorandum to File
                                      No
                                      No
                          EPA-HQ-OECA-2019-0408-0037
                                      N/A
National Pollutant Discharge Elimination System (NPDES) Electronic Reporting Rule: Phase 2 Extension
                                   U.S. EPA
                                  11/02/2020
                    Federal Register Notice  -  Final Rule
                                      N/A
                                      No
                          EPA-HQ-OECA-2019-0408-0031


[Federal Register Volume 81, Number 232 (Friday, December 2, 2016)]
[Notices]
[Pages 87041-87042]
[FR Doc No: 2016-28916]

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

DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket Nos. FDA-2015-E-3158; FDA-2015-E-3159]

Determination of Regulatory Review Period for Purposes of Patent
Extension; TRUMENBA

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice.

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

SUMMARY: The Food and Drug Administration (FDA) has determined the
regulatory review period for TRUMENBA and is publishing this notice of
that determination as required by law. FDA has made the determination
because of the submission of an application to the Director of the U.S.
Patent and Trademark Office (USPTO), Department of Commerce, for the
extension of a patent which claims that human biological product.

DATES: Anyone with knowledge that any of the dates as published (see
the SUPPLEMENTARY INFORMATION section) are incorrect may submit either
electronic or written comments and ask for a redetermination by January
31, 2017. Furthermore, any interested person may petition FDA for a
determination regarding whether the applicant for extension acted with
due diligence during the regulatory review period by May 31, 2017. See
``Petitions'' in the SUPPLEMENTARY INFORMATION section for more
information.

ADDRESSES: You may submit comments as follows:

Electronic Submissions

    Submit electronic comments in the following way:
     Federal eRulemaking Portal: https://www.regulations.gov.
Follow the instructions for submitting comments. Comments submitted
electronically, including attachments, to https://www.regulations.gov
will be posted to the docket unchanged. Because your comment will be
made public, you are solely responsible for ensuring that your comment
does not include any confidential information that you or a third party
may not wish to be posted, such as medical information, your or anyone
else's Social Security number, or confidential business information,
such as a manufacturing process. Please note that if you include your
name, contact information, or other information that identifies you in
the body of your comments, that information will be posted on https://www.regulations.gov.
     If you want to submit a comment with confidential
information that you do not wish to be made available to the public,
submit the comment as a written/paper submission and in the manner
detailed (see ``Written/Paper Submissions'' and ``Instructions'').

Written/Paper Submissions

    Submit written/paper submissions as follows:
     Mail/Hand delivery/Courier (for written/paper
submissions): Division of Dockets Management (HFA-305), Food and Drug
Administration, 5630 Fishers Lane, Rm. 1061, Rockville, MD 20852.
     For written/paper comments submitted to the Division of
Dockets Management, FDA will post your comment, as well as any
attachments, except for information submitted, marked and identified,
as confidential, if submitted as detailed in ``Instructions.''
    Instructions: All submissions received must include the Docket Nos.
FDA-2015-E-3158 and FDA-2015-E-3159 for ``Determination of Regulatory
Review Period for Purposes of Patent Extension; TRUMENBA.'' Received
comments will be placed in the docket and, except for those submitted
as ``Confidential Submissions,'' publicly viewable at https://www.regulations.gov or at the Division of Dockets Management between 9
a.m. and 4 p.m., Monday through Friday.
     Confidential Submissions--To submit a comment with
confidential information that you do not wish to be

made publicly available, submit your comments only as a written/paper
submission. You should submit two copies total. One copy will include
the information you claim to be confidential with a heading or cover
note that states ``THIS DOCUMENT CONTAINS CONFIDENTIAL INFORMATION.''
The Agency will review this copy, including the claimed confidential
information, in its consideration of comments. The second copy, which
will have the claimed confidential information redacted/blacked out,
will be available for public viewing and posted on https://www.regulations.gov. Submit both copies to the Division of Dockets
Management. If you do not wish your name and contact information to be
made publicly available, you can provide this information on the cover
sheet and not in the body of your comments and you must identify this
information as ``confidential.'' Any information marked as
``confidential'' will not be disclosed except in accordance with 21 CFR
10.20 and other applicable disclosure law. For more information about
FDA's posting of comments to public dockets, see 80 FR 56469, September
18, 2015, or access the information at: http://www.fda.gov/regulatoryinformation/dockets/default.htm.
    Docket: For access to the docket to read background documents or
the electronic and written/paper comments received, go to https://www.regulations.gov and insert the docket number, found in brackets in
the heading of this document, into the ``Search'' box and follow the
prompts and/or go to the Division of Dockets Management, 5630 Fishers
Lane, Rm. 1061, Rockville, MD 20852.

FOR FURTHER INFORMATION CONTACT: Beverly Friedman, Office of Regulatory
Policy, Food and Drug Administration, 10903 New Hampshire Ave., Bldg.
51, Rm. 6250, Silver Spring, MD 20993,<PHONE_NUMBER>.

SUPPLEMENTARY INFORMATION:

I. Background

    The Drug Price Competition and Patent Term Restoration Act of 1984
(Pub. L. 98-417) and the Generic Animal Drug and Patent Term
Restoration Act (Pub. L. 100-670) generally provide that a patent may
be extended for a period of up to 5 years so long as the patented item
(human drug product, animal drug product, medical device, food
additive, or color additive) was subject to regulatory review by FDA
before the item was marketed. Under these acts, a product's regulatory
review period forms the basis for determining the amount of extension
an applicant may receive.
    A regulatory review period consists of two periods of time: A
testing phase and an approval phase. For human biological products, the
testing phase begins when the exemption to permit the clinical
investigations of the biological product becomes effective and runs
until the approval phase begins. The approval phase starts with the
initial submission of an application to market the human biological
product and continues until FDA grants permission to market the
biological product. Although only a portion of a regulatory review
period may count toward the actual amount of extension that the
Director of USPTO may award (for example, half the testing phase must
be subtracted as well as any time that may have occurred before the
patent was issued), FDA's determination of the length of a regulatory
review period for a human biological product will include all of the
testing phase and approval phase as specified in 35 U.S.C.
156(g)(1)(B).
    FDA has approved for marketing the human biologic product TRUMENBA
(Meningococcal Group B Vaccine). TRUMENBA is indicated for active
immunization to prevent invasive disease caused by Neisseria
meningitidis serogroup B. Meningococcal Group B Vaccine is approved for
use in individuals 10 through 25 years of age. Subsequent to this
approval, the USPTO received patent term restoration applications for
TRUMENBA (U.S. Patent Nos. 8,101,194 and 8,563,007) from Wyeth Holdings
LLC, and the USPTO requested FDA's assistance in determining the
patents' eligibility for patent term restoration. In a letter dated
October 19, 2015, FDA advised the USPTO that this human biological
product had undergone a regulatory review period and that the approval
of TRUMENBA represented the first permitted commercial marketing or use
of the product. Thereafter, the USPTO requested that FDA determine the
product's regulatory review period.

II. Determination of Regulatory Review Period

    FDA has determined that the applicable regulatory review period for
TRUMENBA is 2,079 days. Of this time, 1,943 days occurred during the
testing phase of the regulatory review period, while 136 days occurred
during the approval phase. These periods of time were derived from the
following dates:
    1. The date an exemption under section 505(i) of the Federal Food,
Drug, and Cosmetic Act (21 U.S.C. 355(i)) became effective: February
20, 2009. FDA has verified the applicant's claim that the date the
investigational new drug application became effective was on February
20, 2009.
    2. The date the application was initially submitted with respect to
the human biological product under section 351 of the Public Health
Service Act (42 U.S.C. 262): June 16, 2014. FDA has verified the
applicant's claim that the biologics license application (BLA) for
TRUMENBA (BLA 125549/0) was initially submitted on June 16, 2014.
    3. The date the application was approved: October 29, 2014. FDA has
verified the applicant's claim that BLA 125549/0 was approved on
October 29, 2014.
    This determination of the regulatory review period establishes the
maximum potential length of a patent extension. However, the USPTO
applies several statutory limitations in its calculations of the actual
period for patent extension. In its application for patent extension,
this applicant seeks 255 days or 573 days of patent term extension.

III. Petitions

    Anyone with knowledge that any of the dates as published are
incorrect may submit either electronic or written comments and ask for
a redetermination (see DATES). Furthermore, any interested person may
petition FDA for a determination regarding whether the applicant for
extension acted with due diligence during the regulatory review period.
To meet its burden, the petition must be timely (see DATES) and contain
sufficient facts to merit an FDA investigation. (See H. Rept. 857, part
1, 98th Cong., 2d sess., pp. 41-42, 1984.) Petitions should be in the
format specified in 21 CFR 10.30.
    Submit petitions electronically to https://www.regulations.gov at
Docket No. FDA-2013-S-0610. Submit written petitions (two copies are
required) to the Division of Dockets Management (HFA-305), Food and
Drug Administration, 5630 Fishers Lane, Rm. 1061, Rockville, MD 20852.

    Dated: November 23, 2016.
Leslie Kux,
Associate Commissioner for Policy.
[FR Doc. 2016-28916 Filed 12-1-16; 8:45 am]
 BILLING CODE 4164-01-P


[Federal Register: August 18, 2010 (Volume 75, Number 159)]
[Notices]
[Page 51048-51049]
[DOCID:fr18au10-94]

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

ENVIRONMENTAL PROTECTION AGENCY

[EPA-HQ-OPP-2010-0649; FRL-8840-2]

Notice of Receipt of Request to Voluntarily Cancel a Pesticide
Registration

AGENCY: Environmental Protection Agency (EPA).

ACTION: Notice.

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

SUMMARY: In accordance with section 6(f)(1) of the Federal Insecticide,
Fungicide, and Rodenticide Act (FIFRA), as amended, EPA is issuing a
notice of receipt of request by the registrant to voluntarily cancel a
pesticide registration.

DATES: Comments must be received on or before September 17, 2010.

ADDRESSES: Submit your comments and your withdrawal request, identified
by docket identification (ID) number EPA-HQ-OPP-2010-0649, by one of
the following methods:
     Federal eRulemaking Portal: http://www.regulations.gov.
Follow the on-line instructions for submitting comments.
     Mail: Office of Pesticide Programs (OPP) Regulatory Public
Docket (7502P), Environmental Protection Agency, 1200 Pennsylvania
Ave., NW., Washington, DC 20460-0001.
     Delivery: OPP Regulatory Public Docket (7502P),
Environmental Protection Agency, Rm. S-4400, One Potomac Yard (South
Bldg.), 2777 S. Crystal Dr., Arlington, VA. Deliveries are only
accepted during the Docket Facility's normal hours of operation (8:30
a.m. to 4 p.m., Monday through Friday, excluding legal holidays).
Special arrangements should be made for deliveries of boxed
information. The Docket Facility's telephone number is<PHONE_NUMBER>.
    Instructions: Direct your comments to docket ID number EPA-HQ-OPP-
2010-0649. EPA's policy is that all comments received will be included
in the docket without change and may be made available on-line at
http://www.regulations.gov, including any personal information
provided, unless the comment includes information claimed to be
Confidential Business Information (CBI) or other information whose
disclosure is restricted by statute. Do not submit information that you
consider to be CBI or otherwise protected through regulations.gov or e-
mail. The regulations.gov website is an ``anonymous access'' system,
which means EPA will not know your identity or contact information
unless you provide it in the body of your comment. If you send an e-
mail comment directly to EPA without going through regulations.gov,
your e-mail address will be automatically captured and included as part
of the comment that is placed in the docket and made available on the
Internet. If you submit an electronic comment, EPA recommends that you
include your name and other contact information in the body of your
comment and with any disk or CD-ROM you submit. If EPA cannot read your
comment due to technical difficulties and cannot contact you for
clarification, EPA may not be able to consider your comment. Electronic
files should avoid the use of special characters, any form of
encryption, and be free of any defects or viruses.
    Docket: All documents in the docket are listed in the docket index
available at http://www.regulations.gov. Although listed in the index,
some information is not publicly available, e.g., CBI or other
information whose disclosure is restricted by statute. Certain other
material, such as copyrighted material, is not placed on the Internet
and will be publicly available only in hard copy form. Publicly
available docket materials are available either in the electronic
docket at http://www.regulations.gov, or, if only available in hard
copy, at the OPP Regulatory Public Docket in Rm. S-4400, One Potomac
Yard (South Bldg.), 2777 S. Crystal Dr., Arlington, VA. The hours of
operation of this Docket Facility are from 8:30 a.m. to 4 p.m., Monday
through Friday, excluding legal holidays. The Docket Facility's
telephone number is<PHONE_NUMBER>.

FOR FURTHER INFORMATION CONTACT: Leonard Cole, Biopesticides and
Pollution Prevention Division (7511P), Office of Pesticide Programs,
Environmental Protection Agency, 1200 Pennsylvania Ave., NW.,
Washington, DC 20460-0001; telephone number:<PHONE_NUMBER>; e-mail
address<EMAIL_ADDRESS>
SUPPLEMENTARY INFORMATION:

I. General Information

A. Does this Action Apply to Me?

    This action is directed to the public in general. Although this
action may be of particular interest to persons who produce or use
pesticides, the Agency has not attempted to describe all the specific
entities that may be affected by this action. If you have any questions
regarding the information in this notice, consult the person listed
under FOR FURTHER INFORMATION CONTACT.

B. What Should I Consider as I Prepare My Comments for EPA?

    1.  Submitting CBI. Do not submit this information to EPA through
regulations.gov or e-mail. Clearly mark the part or all of the
information that you claim to be CBI. For CBI information in a disk or
CD-ROM that you mail to EPA, mark the outside of the disk or CD-ROM as
CBI and then identify electronically within the disk or CD-ROM the
specific information that is claimed as CBI. In addition to one
complete version of the comment that includes information claimed as
CBI, a copy of the comment that does not contain the information
claimed as CBI must be submitted for inclusion in the public docket.
Information so marked will not be disclosed except in accordance with
procedures set forth in 40 CFR part 2.
    2.  Tips for preparing your comments. When submitting comments,
remember to:
    i. Identify the document by docket ID number and other identifying
information (subject heading, Federal Register date and page number).
     ii. Follow directions. The Agency may ask you to respond to
specific questions or organize comments by referencing a Code of
Federal Regulations (CFR) part or section number.
    iii. Explain why you agree or disagree, suggest alternatives and
substitute language for your requested changes.
    iv. Describe any assumptions and provide any technical information
and/or data that you used.
    v. If you estimate potential costs or burdens, explain how you
arrived at your estimate in sufficient detail to allow for it to be
reproduced.
    vi. Provide specific examples to illustrate your concerns and
suggest alternatives.
    vii. Explain your views as clearly as possible, avoiding the use of
profanity or personal threats.
    viii. Make sure to submit your comments by the comment period
deadline identified.

II. What Action is the Agency Taking?

    This notice announces receipt by the Agency of an application from
the registrant to cancel a technical grade active ingredient pesticide
product registered under section 3 or 24(c) of FIFRA. This registration
is listed by registration number, product and chemical name in Table 1
of this unit.

      Table 1.--Registration with Pending Request for Cancellation
------------------------------------------------------------------------
        Registration No.             Product Name        Chemical Name
------------------------------------------------------------------------
70127-4                           Beetleball          4-Allyl Anisole
                                   Technical           (Estragole)
------------------------------------------------------------------------

    Unless this request is withdrawn by the registrant within 30 days
of publication of this notice, orders will be issued canceling this
registration. Users of this pesticide or anyone else desiring the
retention of this registration should contact the registrant directly
during this 30-day period.
    Table 2 of this unit includes the name and address of record for
the registrant listed in Table 1 of this unit by the EPA company
number.

         Table 2.--Registrant Requesting Voluntary Cancellation
------------------------------------------------------------------------
              EPA Company No.                 Company Name and Address
------------------------------------------------------------------------
70127                                       Novozymes Biologicals, Inc.
                                            5400 Corporate Circle
                                            Salem, Virginia 24153
------------------------------------------------------------------------

III. What is the Agency's Authority for Taking this Action?

    Section 6(f)(1) of FIFRA provides that a registrant of a pesticide
product may at any time request that any of its pesticide registrations
be canceled. FIFRA further provides that, before acting on the request,
EPA must publish a notice of receipt of request in the Federal
Register. Thereafter, the Administrator may approve the request.

IV. Procedures for Withdrawal of Request

    Registrants who choose to withdraw a request for cancellation must
submit withdrawal in writing to the person listed under FOR FURTHER
INFORMATION CONTACT, postmarked before September 17, 2010. This written
withdrawal of the request for cancellation will apply only to the
applicable FIFRA section 6(f)(1) request listed in this notice. If the
product has been subject to a previous cancellation action, the
effective date of cancellation and all other provisions of any earlier
cancellation action are controlling. The withdrawal request must also
include a commitment to pay any reregistration fees due, and to fulfill
any applicable unsatisfied data requirements.

V. Provisions for Disposition of Existing Stocks

    Existing stocks are those stocks of registered pesticide products
currently in the United States and were packaged, labeled, and released
for shipment prior to the effective date of the cancellation action.
EPA's existing stocks policy (56 FR 29362) provides that: ``If a
registrant requests to voluntarily cancel a registration where the
Agency has identified no particular risk concerns, the registrant has
complied with all applicable conditions of reregistration, conditional
registration, and data call ins, and the registration is not subject to
the Registration Standard, Label Improvement Program, or reregistration
decision. The Agency will generally permit a registrant to sell or
distribute existing stocks for 1 year after the cancellation request
was received. Persons other than registrants will generally be allowed
to sell, distribute, or use existing stocks until such stocks are
exhausted.''
    Upon cancellation of the pesticide identified in Table 1 of Unit
II., EPA anticipates allowing sale, distribution, and use as described
in this unit. Exception to this general policy will be made in specific
cases when more stringent restrictions on sale, distribution, or use of
the products or their ingredients have already been imposed, as in a
special review action, or where the Agency has identified significant
potential risk concerns associated with a particular chemical.

List of Subjects

    Environmental protection, Pesticides and pests.

    Dated: August 5, 2010.
 W. Michael McDavit,
Acting Director, Biopesticides and Pollution Prevention Division,
Office of Pesticide Programs.

[FR Doc. 2010-20448 Filed 8-17-10; 8:45 am]
BILLING CODE 6560-50-S


[Federal Register Volume 76, Number 28 (Thursday, February 10, 2011)]
[Proposed Rules]
[Pages 7515-7518]
[FR Doc No: 2011-2860]

=======================================================================
-----------------------------------------------------------------------

DEPARTMENT OF HOMELAND SECURITY

Coast Guard

33 CFR Part 165

[Docket No. USCG-2010-1097]
RIN 1625-AA00

Safety Zone; Mississippi River, Mile 842.0 to 839.5

AGENCY: Coast Guard, DHS.

ACTION: Notice of proposed rulemaking.

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

SUMMARY: The Coast Guard proposes establishing a temporary safety zone
for all waters of the Upper Mississippi River, Mile 842.0 to 839.5,
extending the entire width of the river. This safety zone is needed to
protect participants and event personnel during the swim leg of the
OptumHealth Half Iron Triathlon occurring in the Upper Mississippi
River. Entry into this zone would be prohibited unless specifically
authorized by the Captain of the Port Upper Mississippi River or a
designated representative.

DATES: Comments and related material must be received by the Coast
Guard on or before March 14, 2011.

ADDRESSES: You may submit comments identified by docket number USCG-
2010-1097 using any one of the following methods:
    (1) Federal eRulemaking Portal: http://www.regulations.gov.
    (2) Fax:<PHONE_NUMBER>.
    (3) Mail: Docket Management Facility (M-30), U.S. Department of
Transportation, West Building Ground Floor, Room W12-140, 1200 New
Jersey Avenue, SE., Washington, DC 20590-0001.
    (4) Hand delivery: Same as mail address above, between 9 a.m. and 5
p.m., Monday through Friday, except Federal holidays. The telephone
number is<PHONE_NUMBER>.
    To avoid duplication, please use only one of these four methods.
See the ``Public Participation and Request for Comments'' portion of
the SUPPLEMENTARY INFORMATION section

below for instructions on submitting comments.

FOR FURTHER INFORMATION CONTACT: If you have questions on this proposed
rule, call or e-mail Lieutenant (LT) Rob McCaskey, Sector Upper
Mississippi River Response Department at telephone<PHONE_NUMBER>, e-mail
<EMAIL_ADDRESS>If you have questions on viewing or submitting
material to the docket, call Renee V. Wright, Program Manager, Docket
Operations, telephone<PHONE_NUMBER>.

SUPPLEMENTARY INFORMATION:

Public Participation and Request for Comments

    We encourage you to participate in this rulemaking by submitting
comments and related materials. All comments received will be posted
without change to http://www.regulations.gov and will include any
personal information you have provided.

Submitting Comments

    If you submit a comment, please include the docket number for this
rulemaking (USCG-2010-1097), indicate the specific section of this
document to which each comment applies, and provide a reason for each
suggestion or recommendation. You may submit your comments and material
online (via http://www.regulations.gov) or by fax, mail, or hand
delivery, but please use only one of these means. If you submit a
comment online via http://www.regulations.gov, it will be considered
received by the Coast Guard when you successfully transmit the comment.
If you fax, hand deliver, or mail your comment, it will be considered
as having been received by the Coast Guard when it is received at the
Docket Management Facility. We recommend that you include your name and
a mailing address, an e-mail address, or a telephone number in the body
of your document so that we can contact you if we have questions
regarding your submission.
    To submit your comment online, go to http://www.regulations.gov,
click on the ``submit a comment'' box, which will then become
highlighted in blue. In the ``Document Type'' drop down menu select
``Proposed Rule'' and insert ``USCG-2010-1097'' in the ``Keyword'' box.
Click ``Search'' then click on the balloon shape in the ``Actions''
column. If you submit your comments by mail or hand delivery, submit
them in an unbound format, no larger than 8[frac12] by 11 inches,
suitable for copying and electronic filing. If you submit comments by
mail and would like to know that they reached the Facility, please
enclose a stamped, self-addressed postcard or envelope. We will
consider all comments and material received during the comment period
and may change the rule based on your comments.

Viewing Comments and Documents

    To view comments, as well as documents mentioned in this preamble
as being available in the docket, go to http://www.regulations.gov,
click on the ``read comments'' box, which will then become highlighted
in blue. In the ``Keyword'' box insert ``USCG-2010-1097'' and click
``Search.'' Click the ``Open Docket Folder'' in the ``Actions'' column.
You may also visit the Docket Management Facility in Room W12-140 on
the ground floor of the Department of Transportation West Building,
1200 New Jersey Avenue, SE., Washington, DC 20590, between 9 a.m. and 5
p.m., Monday through Friday, except Federal holidays. We have an
agreement with the Department of Transportation to use the Docket
Management Facility.

Privacy Act

    Anyone can search the electronic form of comments received into any
of our dockets by the name of the individual submitting the comment (or
signing the comment, if submitted on behalf of an association,
business, labor union, etc.). You may review a Privacy Act notice
regarding our public dockets in the January 17, 2008, issue of the
Federal Register (73 FR 3316).

Public Meeting

    We do not now plan to hold a public meeting. But you may submit a
request for one on or before February 25, 2011, using one of the four
methods specified under ADDRESSES. Please explain why you believe a
public meeting would be beneficial. If we determine that one would aid
this rulemaking, we will hold one at a time and place announced by a
later notice in the Federal Register.
    For information on facilities or services for individuals with
disabilities or to request special assistance at the public meeting,
contact LT Rob McCaskey at the telephone number or e-mail address
indicated under the FOR FURTHER INFORMATION CONTACT section of this
notice.

Background and Purpose

    On July 24, 2011, OptumHealth will be sponsoring a Half Iron
Triathlon. There will be approximately 2,000 participants swimming the
1.2 mile course. A safety zone will be established at mile marker 842.0
and extend to mile marker 839.5 on the Upper Mississippi River,
extending the entire width of the river. This safety zone is necessary
to protect the safety of participants, event personnel, spectators, and
other users and vessels of the Upper Mississippi River during the swim
leg of the OptumHealth Half Iron Triathlon.

Discussion of Proposed Rule

    The Coast Guard is proposing to establish a safety zone for all
waters of the Upper Mississippi River, Mile 842.0 to 839.5, extending
the entire width of the river. Entry into, transiting through, or
anchoring within this zone would be prohibited to all vessels and
persons except participants and those persons and vessels specifically
authorized by the Captain of the Port Upper Mississippi River. We are
proposing an effective period from 6:30 a.m. until 10:30 a.m. CST July
24, 2011. The Captain of the Port Upper Mississippi River will inform
the public through broadcast notice to mariners of all safety zone
changes and enforcement periods.

Regulatory Analyses

    We developed this proposed rule after considering numerous statutes
and executive orders related to rulemaking. Below we summarize our
analyses based on 13 of these statutes or executive orders.

Regulatory Planning and Review

    This proposed rule is not a significant regulatory action under
section 3(f) of Executive Order 12866, Regulatory Planning and Review,
and does not require an assessment of potential costs and benefits
under section 6(a)(3) of that Order. The Office of Management and
Budget has not reviewed it under that Order. It is not ``significant''
under the regulatory policies and procedures of the Department of
Homeland Security (DHS). This rule would be in effect for only a short
period of time during the swim leg of the OptumHealth Half Iron
Triathlon. Vessels that need to enter the safety zone may request
permission to do so from the Captain of the Port Upper Mississippi
River.

Small Entities

    Under the Regulatory Flexibility Act (5 U.S.C. 601-612), we have
considered whether this proposed rule would have a significant economic
impact on a substantial number of small entities. The term ``small
entities'' comprises small businesses, not-for-profit organizations
that are independently owned and operated and are not dominant in their
fields, and governmental jurisdictions with populations of less than
50,000.

    The Coast Guard certifies under 5 U.S.C. 605(b) that this proposed
rule would not have a significant economic impact on a substantial
number of small entities. This rule will affect the following entities,
some of which may be small entities: The owners or operators of vessels
intending to transit the Upper Mississippi River, Mile 842.0 to 839.5
from 6:30 a.m. until 10:30 a.m. CST on July 24, 2011. This safety zone
would not have a significant economic impact on a substantial number of
small entities for the following reason: (1) This rule would only be in
effect for a limited period of time.
    If you think that your business, organization, or governmental
jurisdiction qualifies as a small entity and that this rule would have
a significant economic impact on it, please submit a comment (see
ADDRESSES) explaining why you think it qualifies and how and to what
degree this rule would economically affect it.

Assistance for Small Entities

    Under section 213(a) of the Small Business Regulatory Enforcement
Fairness Act of 1996 (Pub. L. 104-121), we want to assist small
entities in understanding this proposed rule so that they can better
evaluate its effects on them and participate in the rulemaking. If the
rule would affect your small business, organization, or governmental
jurisdiction and you have questions concerning its provisions or
options for compliance, please contact 1-888-REG-FAIR (1-888-734-3247).
The Coast Guard will not retaliate against small entities that question
or complain about this proposed rule or any policy or action of the
Coast Guard.

Collection of Information

    This proposed rule would call for no new collection of information
under the Paperwork Reduction Act of 1995 (44 U.S.C. 3501-3520).

Federalism

    A rule has implications for federalism under Executive Order 13132,
Federalism, if it has a substantial direct effect on State or local
governments and would either preempt State law or impose a substantial
direct cost of compliance on them. We have analyzed this proposed rule
under that Order and have determined that it does not have implications
for federalism.

Unfunded Mandates Reform Act

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

Taking of Private Property

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

Civil Justice Reform

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

Protection of Children

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

Indian Tribal Governments

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

Energy Effects

    We have analyzed this proposed rule under Executive Order 13211,
Actions Concerning Regulations That Significantly Affect Energy Supply,
Distribution, or Use. We have determined that it is not a ``significant
energy action'' under that order because it is not a ``significant
regulatory action'' under Executive Order 12866 and is not likely to
have a significant adverse effect on the supply, distribution, or use
of energy. The Administrator of the Office of Information and
Regulatory Affairs has not designated it as a significant energy
action. Therefore, it does not require a Statement of Energy Effects
under Executive Order 13211.

Technical Standards

    The National Technology Transfer and Advancement Act (NTTAA) (15
U.S.C. 272 note) directs agencies to use voluntary consensus standards
in their regulatory activities unless the agency provides Congress,
through the Office of Management and Budget, with an explanation of why
using these standards would be inconsistent with applicable law or
otherwise impractical. Voluntary consensus standards are technical
standards (e.g., specifications of materials, performance, design, or
operation; test methods; sampling procedures; and related management
systems practices) that are developed or adopted by voluntary consensus
standards bodies.
    This proposed rule does not use technical standards. Therefore, we
did not consider the use of voluntary consensus standards.

Environment

    We have analyzed this proposed rule under Department of Homeland
Security Management Directive 023-01 and Commandant Instruction
M16475.lD, which guide the Coast Guard in complying with the National
Environmental Policy Act of 1969 (NEPA) (42 U.S.C. 4321-4370f), and
have made a preliminary determination that this action is one of a
category of actions that do not individually or cumulatively have a
significant effect on the human environment. We believe this rule is
categorically excluded, under figure 2-1, paragraph (34)(g), of the
Instruction. A preliminary environmental analysis checklist supporting
this determination is available in the docket where indicated under
ADDRESSES. This proposed rule involves the establishment of a safety
zone. We seek any comments or information that may lead to the
discovery of a significant environmental impact from this proposed
rule.

List of Subjects in 33 CFR Part 165

    Harbors, Marine safety, Navigation (water), Reporting and
recordkeeping requirements, Security measures, Waterways.

    For the reasons discussed in the preamble, the Coast Guard proposes
to amend 33 CFR part 165 as follows:

PART 165--REGULATED NAVIGATION AREAS AND LIMITED ACCESS AREAS

    (1) The authority citation for part 165 continues to read as
follows:

    Authority: 33 U.S.C. 1226, 1231; 46 U.S.C. Chapter 701, 3306,
3703; 50 U.S.C. 191, 195; 33 CFR 1.05-1, 6.04-1, 6.04-6, and 160.5;

Pub. L. 107-295, 116 Stat. 2064; Department of Homeland Security
Delegation No. 0170.1.

    (2) Add Sec.  165.T08-1097 to read as follows:

Sec.  165.T08-1097  Safety Zone; Upper Mississippi River, Mile 842.0 to
839.5.

    (a) Location. The following area is a safety zone: All waters of
the Upper Mississippi River, Mile 842.0 to 839.5 extending the entire
width of the waterway.
    (b) Effective date. This rule is effective from 6:30 a.m. until
10:30 a.m. on July 24, 2011.
    (c) Periods of Enforcement. This rule will be enforced from 6:30
a.m. until 10:30 a.m. CST on July 24, 2011. The Captain of the Port
Upper Mississippi River will inform the public through broadcast notice
to mariners of all safety zone changes and enforcement periods.
    (d) Regulations. (1) In accordance with the general regulations in
Sec.  165.23 of this part, entry into this zone is prohibited unless
authorized by the Captain of the Port Upper Mississippi River or a
designated representative.
    (2) Persons or vessels requiring entry into or passage through the
zone must request permission from the Captain of the Port Upper
Mississippi River or a designated representative. The Captain of the
Port Upper Mississippi River representative may be contacted at 314-
269-2332.
    (3) All persons and vessels must comply with the instruction of the
Captain of the Port Upper Mississippi River or their designated
representative. Designated Captain of the Port representatives includes
United States Coast Guard commissioned, warrant, and petty officers of
the U.S. Coast Guard.

    Dated: January 25, 2011.
S.L. Hudson,
Captain, U.S. Coast Guard, Captain of the Port Upper Mississippi River.
[FR Doc. 2011-2860 Filed 2-9-11; 8:45 am]
BILLING CODE 9110-04-P


DWCGI 25194 1068138690 12196000. WK4 Table 1 Hours and Costs Per Activity Information Collection Activity Number Attorney Hours Attorney Wage/ Hr Manager Hours Manager Wage/ Hr Technical Hours Technical Wage/ Hr Clerical Hours Clerical Wage/ Hr Total Hours Per Request Total Number of FOIA requests for CBI received by all EPA Program Offices and Regions per year 1384 Total number of other events ( e. g., litigation or rulemaking)

that require EPA to examine the confidentiality of business information per year 617 Total number of EPA requests to industry for substantiation of CBI claims per year 543 Level of EPA effort to review information, make a preliminary determination, and request substantiation from industry 543 4.00 $ 62.90 2.00 $ 53.22 1.00 $ 30.86 7.00 Number of respondents deciding not to submit substantiations per year 100 Level of industry effort to review the information claimed as confidential and decide not to comment 100 0.50 $ 69.76 0.50 $ 73.52 0.00 $ 35.81 1.00 Number of respondents submitting substantiations per year 443 Level of industry effort to respond to each substantiation request 443 2.20 $ 126.00 4.00 $ 69.76 7.00 $ 73.52 1.00 $ 35.81 14.20 Level of EPA effort to review each substantiation and make a final confidentiality determination 443 6.00 $ 62.90 2.00 $ 53.22 0.00 $ 30.86 8.00 Number of contractor/ subcontractor companies who are given access to CBI 129 Number of contractor/ subcontractor employees who must sign confidentiality agreements and the related level of effort 658 0.10 $ 69.76 0.00 0.00 0.10 Level of effort for contractor/ subcontractor businesses to file and maintain confidentiality agreements 129 0.00 0.00 0.50 $ 35.81 0.50 Total DWCGI 25194 1068138690 12196000. WK4 Table 1 KEY: Wage Rates for EPA Activities Attorney Wage/ Hr = Wage per hour for a GS 14 Step 5 Attorney.

Technical Wage/ Hr = Wage per hour for a GS 13 Step 5 Technical employee.

Clerical Wage/ Hr = Wage per hour for a GS 9 Step 5 Clerical/ Administrative employee.

* EPA wages/ hr taken from the U. S. Office of Personnel Management's 2003 General Schedule  Base Rates, Excluding Locality Rates of Pay Wage Rates for Industry and Contractor/ Subcontractor Activities Manager Wage/ Hr = Wage per hour for private industry Managers and adminstrators, n. e. c.

Technical Wage/ Hr = Wage per hour for private industry Chemical engineers Clerical Wage/ Hr = Wage per hour for private industry supervisors, general office * Wages/ hr taken from the U. S. Department of Labor, Bureau of Labor Statistics " National Compensation Survey: Occupational Wages in the United States, 2001", Bulletin 2552, ( January 2003).

* All wages have been fully loaded to include additional administrative costs. DWCGI 25194 1068138690 12196000. WK4 Table 1 Total Costs Per Request Total Hours for All Requests Total Costs for All Requests $ 388.88 3,801.00 $ 211,161.84 $ 71.64 100.00 $ 7,164.00 $ 1,106.70 6,290.60 $ 490,268.10 $ 483.81 3,544.00 $ 214,327.83 $ 6.98 65.80 $ 4,592.84 $ 17.90 64.50 $ 2,309.10 13,865.90 $ 929,823.71 DWCGI 25194 1068138690 12196000. WK4 Table 1