[Federal Register: November 10, 2005 (Volume 70, Number 217)]
[Notices]
[Page 68423-68424]
[DOCID:fr10no05-80]

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DEPARTMENT OF ENERGY

Federal Energy Regulatory Commission

[Docket No. ER06-89-000]

ISO New England Inc.; Notice of Filing

November 2, 2005.
    Take notice that on October 28, 2005, ISO New England Inc. (ISO),
and the New England Power Pool Participants Committee (NEPOOL) hereby
jointly submit a transmittal letter and the interim revision to Market
Rule 1 to aid the ISO in implementing its Winter 2005/2006 Action Plan.
    Any person desiring to intervene or to protest this filing must
file in accordance with Rules 211 and 214 of

the Commission's Rules of Practice and Procedure (18 CFR 385.211,
385.214). Protests will be considered by the Commission in determining
the appropriate action to be taken, but will not serve to make
protestants parties to the proceeding. Any person wishing to become a
party must file a notice of intervention or motion to intervene, as
appropriate. Such notices, motions, or protests must be filed on or
before the comment date. Anyone filing a motion to intervene or protest
must serve a copy of that document on the Applicant and all the parties
in this proceeding.
    The Commission encourages electronic submission of protests and
interventions in lieu of paper using the ``eFiling'' link at http://www.ferc.gov.
 Persons unable to file electronically should submit an

original and 14 copies of the protest or intervention to the Federal
Energy Regulatory Commission, 888 First Street, NE., Washington, DC
20426.
    This filing is accessible on-line at http://www.ferc.gov, using the

``eLibrary'' link and is available for review in the Commission's
Public Reference Room in Washington, DC. There is an ``eSubscription''
link on the Web site that enables subscribers to receive e-mail
notification when a document is added to a subscribed docket(s). For
assistance with any FERC Online service, please e-mail
<EMAIL_ADDRESS>or call<PHONE_NUMBER> (toll free). For

TTY, call<PHONE_NUMBER>.
    Comment Date: 5 p.m. eastern time on November 14, 2005.

Magalie R. Salas,
Secretary.
[FR Doc. E5-6185 Filed 11-9-05; 8:45 am]

BILLING CODE 6717-01-P


EPA NRC TCEQ WDEQ UCL[j] Geochem Average Low Median High Trace and Minor Elements Aluminum                                       Yes                                                                                Yes $13.63 $8.00 $14.40 $19.00 Antimony                                       Yes                                                                                $13.63 $8.00 $14.40 $19.00 Arsenic                                       Yes                                       Yes                                       Yes                                       Yes                                                                                $13.63 $8.00 $14.40 $19.00 Barium                                       Yes                                       Yes                                                                                $13.63 $8.00 $14.40 $19.00 Beryllium                                       Yes                                                                                $13.63 $8.00 $14.40 $19.00 Boron                                                                               Yes                                                                               Yes                                                                                $13.63 $8.00 $14.40 $19.00 Cadmium                                       Yes                                       Yes                                       Yes                                       Yes                                                                                $13.63 $8.00 $14.40 $19.00 Chromium                                       Yes                                       Yes                                                                               Yes                                                                                $13.63 $8.00 $14.40 $19.00 Cobalt                                       Yes                                                                                $11.83 $8.00 $10.00 $19.00 Copper                                       Yes                                       Yes                                                                                $13.63 $8.00 $14.40 $19.00 Fluoride                                       Yes                                       Yes                                       Yes                                       Yes                                                                               Yes $16.50 $12.00 $15.50 $21.00 Iron[i]                                       Yes                                       Yes                                       Yes                                       Yes                                                                      Yes (Total and Fe2+) $13.97 $8.00 $14.40 $19.00 Lead                                       Yes                                       Yes                                       Yes                                                                                $13.63 $8.00 $14.40 $19.00 Manganese                                       Yes                                       Yes                                       Yes                                       Yes                                                                               Yes $13.97 $8.00 $14.40 $19.00 Mercury                                       Yes                                       Yes                                       Yes                                                                                $17.13 $8.00 $14.40 $37.00 Molybdenum                                       Yes                                       Yes                                       Yes                                       Yes                                                                                $13.63 $8.00 $14.40 $19.00 Nickel                                       Yes                                       Yes                                                                                $13.63 $8.00 $14.40 $19.00 Selenium                                       Yes                                       Yes                                       Yes                                       Yes                                                                                $13.63 $8.00 $14.40 $19.00 Silver                                       Yes                                       Yes                                                                                $13.63 $8.00 $14.40 $19.00 Thallium                                       Yes                                                                                $13.63 $8.00 $14.40 $19.00 Tin                                       Yes                                                                                $11.00 $8.00 $10.00 $19.00 Uranium                                       Yes                                       Yes                                       Yes                                       Yes                                                                               Yes $16.13 $8.00 $16.00 $25.00 Vanadium                                 Yes & V2O5                                       Yes                                                                               Yes                                                                                $11.33 $8.00 $10.00 $16.00 Zinc                                       Yes                                       Yes                                                                                $13.63 $8.00 $14.40 $19.00                                                                     (continued) Table B-1.	Analysis Costs for Analytes Generally Required in ISR Groundwater Monitoring Programs (2011$) (continued) Species Requirements by Analyte Group Analysis Cost (sample[-1])

EPA NRC TCEQ WDEQ UCL[j] Geochem Average Low Median High Common Constituents Alkalinity                                                                               Yes                                                                                Yes                                       Yes $16.33 $10.00 $16.00 $23.00 Ammonia                                                                                Yes                                       Yes                                                                           Yes (NH4+) $23.75 $15.00 $22.50 $35.00 Bicarbonate                                                                               Yes                                       Yes                                       Yes                                                                               Yes $13.00 $13.00 $13.00 $13.00 Calcium                                                                               Yes                                       Yes                                       Yes                                                                               Yes $12.17 $8.00 $10.00 $19.00 Carbonate                                                                               Yes                                       Yes                                       Yes                                                                               Yes $13.00 $13.00 $13.00 $13.00 Chloride                                       Yes                                       Yes                                       Yes                                       Yes                                       Yes                                       Yes $16.17 $10.00 $17.00 $21.00 Magnesium                                                                               Yes                                       Yes                                       Yes                                                                               Yes $14.00 $8.00 $10.00 $29.00 Nitrate                                       Yes                                       Yes                                       Yes                                       Yes                                                                               Yes $20.60 $12.00 $20.00 $30.00 Nitrite                                       Yes                                                                                Yes                                                                                $19.83 $12.00 $20.00 $26.00 Phosphate[e]                                                                                Yes $23.33 $20.00 $25.00 $25.00 Potassium                                                                               Yes                                       Yes                                       Yes                                                                               Yes $14.00 $8.00 $10.00 $29.00 Silica                                                                                Yes                                                                                Yes $23.50 $10.00 $26.00 $32.00 Sodium                                                                               Yes                                       Yes                                       Yes                                                                               Yes $14.00 $10.00 $14.00 $18.00 Sulfate                                       Yes                                       Yes                                       Yes                                       Yes                                                                               Yes $16.17 $10.00 $17.00 $21.00 Sulfide                                       Yes                                                                                Yes                                                                               Yes $38.00 $35.00 $39.00 $40.00 Chemical and Physical Indicators Anion/Cation Balance                                                                                Yes $10.00 $10.00 $10.00 $10.00 Specific Conductivity                                                                             Yes[a]                                       Yes                                                                               Yes                                       Yes $13.67 $10.00 $12.00 $19.00 pH                                       Yes                                     Yes[a]                                       Yes                                                                                Yes $11.00 $8.00 $10.00 $17.00 Redox Potential                                                                                Yes $45.00 $45.00 $45.00 $45.00 Total Dissolved Solids                                       Yes                                     Yes[b]                                       Yes                                       Yes                                       Yes                                       Yes $19.33 $12.00 $18.00 $31.00 Temperature                                                                                Yes NA NA NA NA Turbidity[f]                                                                                Yes $15.00 $15.00 $15.00 $15.00 Dissolved Oxygen[g]                                                                                Yes $18.67 $10.00 $11.00 $35.00                                                                     (continued) Table B-1.	Analysis Costs for Analytes Generally Required in ISR Groundwater Monitoring Programs (2011$) (continued) Species Requirements by Analyte Group Analysis Cost (sample[-1])

EPA NRC TCEQ WDEQ UCL[j] Geochem Average Low Median High Chemical and Physical Indicators (continued) Dissolved Organic and Inorganic Carbon[h]                                                                                Yes $39.00 $32.00 $35.00 $50.00 Eh                                                                                Yes NA NA NA NA Radiological Parameters Gross Alpha                                       Yes                                     Yes[c]                                                                               Yes                                                                               Yes $48.33 $40.00 $50.00 $55.00 Gross Beta                                                                               Yes                                                                               Yes                                                                                $45.00 $40.00 $45.00 $50.00 Radium-226                                        Yes                                     Yes[d]                                       Yes                                       Yes                                                                               Yes $77.25 $75.00 $75.50 $83.00 Radium-228                                       Yes                                     Yes[d]                                                                               Yes                                                                                $83.00 $70.00 $79.00 $104.00 Beta + Gamma                                       Yes                                                                                $75.00 $75.00 $75.00 $75.00 Totals:                                       33                                       35                                       25                                       28                                        4                                       29

[a] Field and laboratory determination [b] Laboratory only [c] Excluding radon, radium, and uranium [d] If site initial sampling indicates the presence of Th-232, then Ra-228 should be considered in the baseline sampling or an alternative may be proposed [e] Phosphate costs from Cooperative Chemical Analytical Laboratory, Midwest Laboratories, Energy Laboratories Inc. [f] Turbidity costs from Cooperative Chemical Analytical Laboratory (http://www.ccal.oregonstate.edu/fees.htm) [g] Dissolved oxygen costs from Midwest Laboratories, San Antonio River Authority, and Aquatic & Consulting Testing Inc. [h] Dissolved Organic and Inorganic Carbon from Cooperative Chemical Analytical Laboratory, two method (Combustion-Infrared and Sparge-Infrared) fees were combined for a total cost of analyzing both species (http://www.ccal.oregonstate.edu/fees.htm) [i] Dissolved and total [j] UCL -- upper control limit/excursion parameters. B.2	Groundwater Sampling Unit Costs Included in the unit cost for groundwater sampling are the: laboratory analysis costs, labor cost of contractor personnel to collect the sample, expenses for contractor personnel to travel to the site, contractor fees (assumed 8%), and a contingency of 10% of all calculated costs. These costs were calculated for each analyte group (i.e., EPA, NRC, etc.) and are summarized in Table B-2. The following items are not included or considered in the unit costs: materials (e.g., bottles, gloves, and reagents) sample transport to laboratory lodging record keeping, well maintenance during stability monitoring, sample disposal, as well as the impact of using on site personnel, rather than contractor personnel. Table B-2.	Unit Cost for Groundwater Sampling with Analysis Costs (2011$) Component Species Analyzed

EPA NRC TCEQ WDEQ Geochem. Group Analysis (Average Costs) $741 $700 $447 $665 $629 Direct Labor (hr[-1]) $200 $200 $200 $200 $200 Indirect Labor (hr[-1]) $46 $47 $47 $47 $47 Travel $26 $26 $26 $26 $26 Fee (8%) $25 $25 $25 $25 $25 Contingency (10%) $34 $34 $34 $34 $34 Total $1,073 $1,032 $779 $997 $961

These costs, individually and in total, were considered a small portion of the sum of analysis and labor costs. B.3	Parameter References ACTI (Aquatic & Consulting Testing Inc.), 2005. "Biological and Analytical Chemistry Services." Available at: http://www.aquaticconsulting.com/fee%20schedule.pdf [Accessed March 23, 2013]. BVNA (Bureau Veritas North America), 2010. "Schedule 66, Scientific Equipment and Services," Number: GS-07F-6029R, Period: 17 Aug 2010  - 17 Aug 2015. CCAL (Cooperative Chemical Analytical Laboratory), 2012. "CCAL Fee Schedule for FY13." Available at: http://www.ccal.oregonstate.edu/fees.htm [Accessed March 23, 2013]. NDHHS (Nebraska Department of Health and Human Services), 2010. "Analyte/Price List, Nebraska NDHHS Laboratory 2009-10." TDSHS (Texas Department of State Health Services), 2007. "2007 TDSHS Fee Schedule -- Austin Lab," CLIA ID #: 45D0660644, Tax ID # 32-0113643. ELI (Energy Laboratories, Inc.), 2011. "Analytical Services 2011." ELI (Energy Laboratories Inc.), 2013. "Technical Services and Fee Schedule 2013." Available at: http://www.energylab.com/asp/PricingGuide/docs/ELI_2013_Fee_Schedule_-_ALL_SECTIONS_v0.pdf [Accessed March 23, 2013]. ML (Midwest Laboratories), 2013. "Schedule of Fees 2013." Available at: https://www.midwestlabs.com/wp-content/uploads/2013/01/Midwest-Labs-Schedule-of-Fees-2013.pdf [Accessed March 23, 2013]. Pace (Pace Analytical Services Inc.), 2009. "Minneapolis, MN Laboratory, 2009 Pricing Information," Revised 1/1/09. SARA (San Antonio River Authority), 2012. "Analytical Services Fee Schedule." Available at: http://www.sara-tx.org/public_services/laboratory_services/docs/Fee-schedule-2012.pdf [Accessed March 23, 2013]. U.S. Environmental Protection Agency (EPA), 2012a. Considerations Related to Post Closure Monitoring of Uranium In-Situ Leach/In-Situ Recovery (ISL/ISR) Sites: Background Information Document for the Revision of 40 CFR Part 192. Radiation Protection Division, Office of Air and Radiation. U.S. Environmental Protection Agency (EPA), 2012b. Data collected (WA 2-04, Task B) and provided by EPA. March 26. Appendix C: Simulation of Remobilized Uranium from a Restored ISR Mine This appendix documents modeling simulations of a plume that could develop within an ore body after ISR mining and restoration have been completed. The scenario represents conditions that have destabilized the restored wellfield years after restoration of the production unit had been completed. The destabilization is due to a natural influx of oxidized groundwater from up-gradient of the mine unit that oxidizes the remaining uranium in the wellfield making it more mobile, thereby allowing a groundwater contamination plume to develop and allow the migration of the constituents down-gradient into the rest of the wellfield and potentially into the aquifer below the production zone. For this situation to develop, the mechanisms that were responsible for sequestering the uranium initially would have to be destroyed or dramatically weakened by the uranium recovery process so that the restoration process amounted to only a temporary re-establishment of chemically reducing conditions in the ore zone. For that situation, the movement of oxygenated groundwater into the production zone from up-gradient could, over time, re-oxidize the uranium and allow migration of the contaminants down-gradient. The simulations illustrate the potential behavior of a remobilized contamination plume for the example mine site in Wyoming with the model setup generally based on actual conditions at the Highland site. It should be noted, however, that the model is for illustrative purposes only and the results do not suggest that the scenarios developed have or will occur at the example site. Varying groundwater flow directions were considered for the conceptual mine unit (CMU) based on data from Wellfield-E documentation (Michel and Hoffman, 1991). A general groundwater flow direction, longitudinal with the linear extent of the ore zone, was assumed that could have been either induced from nearby pumping centers (e.g., other ISL production units) or preferential flow toward abandoned, idle, or active underground mine units that were nearby (see Fig. 3-1). A typical groundwater flow direction perpendicular to the length or face of the ore zone front was also considered for the remediation scenarios. Even though a more eastward groundwater flow gradient is characteristic of the 50-sand unit due to the influence of other nearby pumping or groundwater drainage points, the modeled simulations of groundwater flow predict plume migration under ambient conditions that exist without any active pumping or extraction at the mine site. The simulations also predict plume migration under hypothetical pump and treat remediation scenarios, assuming the remobilized plume is discovered and actively remediated. The modeling results were used to support the estimation of remediation costs for a generally small and larger sized plume. C.1	Background The ISR mining process involves the injection of oxidizing agents and other chemicals (the lixiviants) into the ore zone to mobilize uranium for subsequent extraction. The oxidizing agents remove iron sulfides and reactive organic material in addition to uranium. Such naturally-occurring reducing agents were typically responsible for the original uranium sequestration that formed the ore deposit. The restoration process (following the ISR mining) is intended to return the aquifer to a chemically reducing environment similar to pre-mine conditions, thereby immobilizing uranium and other potential contaminants. However, the restoration process can have a limited potential to restore reducing conditions, particularly over long time periods. If levels of iron sulfides and organics have been reduced significantly by the mining process, attempts at restoration may only have a short term effect. The restoration may reduce uranium concentrations in groundwater, but unless a strongly chemically reducing environment is in place, concentrations may later increase. If more oxidizing groundwater enters the mine unit from up-gradient, it can re-oxidize the uranium, thereby increasing concentrations and creating an inorganic contaminant plume of uranium plus other metals (e.g., thorium) in groundwater. This plume could migrate out of the mine unit and impact down-gradient areas of the aquifer, particularly if there is not a strong reducing environment down-gradient, and potentially impacting beneficial groundwater uses. Effects of uranium re-mobilization could be mitigated through natural attenuation processes that reduce down-gradient concentrations. The key attenuation mechanisms are dispersion along the flow path, sorption of uranium on the aquifer materials, and chemical reduction. The model simulations include mechanisms of dispersion and linear equilibrium sorption. Chemical reduction (and oxidation) processes require more information and more complex modeling than attempted for this evaluation. C.2	Approach The assessment uses the groundwater flow model MODFLOW (McDonald and Harbaugh, 1983) and the groundwater transport model MT3DMS (Zheng and Wang, 1999). These codes are well accepted in the technical community and widely used for groundwater and contamination fate and transport modeling. Table C-1 provides input parameter values developed to represent the case study site.

Table C-1.	Input Parameter Values  Parameter Value Unit Source Hydraulic Conductivity (K) 2.20 m/day Michel, Thomas G. and George Hoffman (July 1991). Hydraulic gradient 0.0135  --  Michel, Thomas G. and George Hoffman (July 1991). Porosity 0.20  --  Typical Aquifer top elevation 1351 m Michel, Thomas G. and George Hoffman (July 1991); Plate 2-1 and 2-1. Aquifer bottom elevation 1341 m Michel, Thomas G. and George Hoffman (July 1991); Plate 2-1 and 2-1. Head at up-gradient plume boundary (ambient flow) 1570 m Michel, Thomas G. and George Hoffman (July 1991); Plate 4-2, head near up-gradient ore body location Pore velocity 0.15 m/day Calculated (K*gradient/porosity) Dispersivity 30 m[2]/day Estimated as 0.1*plume scale*pore velocity; plume scale=2000 m (http://www.iowadnr.gov/portals/ idnr/uploads/ust/monohydrocarbonsguide.pdf) Bulk density 2.00E+06 gm/m[3] McWorter, David B. and Daniel K. Sunada, 2010 Ore body length 1600 m Based on length of northern ore body and configuration of Wellfield E Ore body width 400 m Based on width of northern ore body and configuration of Wellfield E Initial dissolved concentration 0.10 mg/L=gm/m[3] Communication with EPA and data from Wellfield E annual reports Target dissolved concentration 0.03 mg/L=gm/m[3] Communication with EPA Kd minimum 1.00E-06 m[3]/gm (0.03 mL/gm) Pearson et al., 1983 and communication with EPA Kd maximum 1.00E-05 m[3]/gm (2200 mL/gm) Pearson et al., 1983 and communication with EPA Pumping rate (per well) 164 m[3]/day Michel, Thomas G. and George Hoffman (July 1991).

The model domain is rectangular and extends 10,000 m from the ore body in all directions. A line of constant head boundary cells along the up-gradient and down-gradient edges of the domain. The specified head values were set so that the ambient/background groundwater flow gradient matched the gradient at the example mine site. A rectangular plume with a similar geometry to the ore body (see Figures 3-1 and 3-2) was delineated in the middle of the model domain with a concentration of 0.1 mg/L. The simulations predict the time for the plume concentrations to decrease below 0.03 mg/L and any associated plume migration. The sorption partition coefficient (Kd) controls the degree of linear sorption represented by the model. The Kd variable is site specific and limited examples were found for actual ISR sites that were measured either as part of baseline or after restoration was completed. The value selected for modeling purposes was a referenced (F.J. Pearson Jr., C.J. Noronha, and R.W. Andrews, 1983) Kd measured at a roll front sandstone site and was used as a representative general condition. This value was varied for the simulations between 1e-6 and 1e-5 m[3]/gm to examine the sensitivity of the projections to the assigned value for this uncertain parameter. The simulations predict plume migration under two flow-direction scenarios: 1) groundwater flow oriented parallel to the length of the original ore body; 2) groundwater flow oriented transverse to the length of the original ore body. The expected direction of groundwater flow would be perpendicular to the length of the ore body; however, a scenario was also considered with groundwater flow along the length of the ore body that would simulate geologic conditions where the modern flow regime was different than when the deposit was formed, and for cases where anthropogenic activities had altered the natural groundwater flow in the aquifer. The simulations predict plume migration under two flow field scenarios: 1) flow under ambient conditions with no groundwater pumping; 2) flow under hypothetical pump and treat scenarios that include groundwater injection as well as extraction wells. The pump and treat scenarios were selected to reduce plume concentrations below the target concentration (0.03 mg/L) in 100 years or less. More aggressive pump and treat designs could result in shorter remediation times. The selected scenarios were considered reasonable representations under the idealized model conditions. The scenario involving ambient flow rates without the pump and treat remediation is an assessment of the potential for natural attenuation mechanisms to contain the contamination plume. With flow parallel to the length of the deposit, the pump and treat scenario includes a line of extraction wells through the center of the plume. The scenario also includes lines of extraction wells along the upper and lower plume boundaries (see Figure C-1). This configuration induces flow between the injection and extraction wells, removing contaminated groundwater and injecting treated water. In all scenarios, the total injection rate matches the extraction rate. At points of injection is the flow rate is 82 ft/day, and at extraction points the flow rate is 164 ft[3]/day. As illustrated in Figure C-1, constituent concentrations are continually lowered over time while the plume is contained within the treatment area. Figure C-1.	Example Simulations with Flow Oriented Parallel to the Strike of the Ore Body; Kd=6e-6 m3/gm; Pump and Treat

With flow perpendicular to the length (or length) of the deposit, the pump and treat scenario includes a line of injection wells along the up-gradient plume edge. The scenario also includes a line of extraction wells along the down-gradient plume edge (see Figure C-2). This configuration induces flow between the injection and extraction wells, removing contaminated groundwater and injecting treated water. In all scenarios, the total injection rate matches the extraction rate. The flow at injection wells is at 164 ft[3]/day, and flow from extraction wells is at 164 ft[3]/day. As illustrated in Figure C-2, constituent concentrations are continually lowered over time while the plume is contained within the treatment area. Water is injected and flows down-gradient to the extraction wells, thereby flushing contamination to the extraction wells and reducing contaminant concentrations. C.3	Simulation Results Table C-2 summarizes the results of the modeling assessment for each scenario. The results are very sensitive to the Kd parameter that controls the degree of linear sorption represented by the model. Table C-2 includes the calculated retardation factor, which indicates how much slower the contaminant plume moves due to sorption when compared to groundwater flow. The results illustrate that significant down-gradient migration of a remobilized plume is possible before natural attenuation mechanisms reduce concentrations below acceptable levels. For this situation, remediation intervention approaches are necessary to prevent large scale migration of the contamination. In addition, plume migration times are relatively slow under ambient flow conditions (the scenarios with no P&T component), further indicating that active remediation efforts would be needed to address the contamination potential. Consistently, pump and treat remediation times are relatively slow, requiring decades or longer to reduce concentrations to acceptable levels. In any particular field situation, the time frames for oxidizing waters to re-enter a well field that was not permanently returned to a strongly reducing chemical regime by the restoration process will vary based on site-specific conditions. Reliable prediction of when, and if, re-mobilization may take place is not possible without a thorough geochemical characterization of site conditions after the restoration process has been completed and continued monitoring of those conditions. For developing the geochemical model, it is important to characterize conditions down-gradient from the ore body. As mentioned earlier, chemically reducing conditions in the sandstone host rock were responsible for originally sequestering the uranium and the presence of these conditions in the portion of the aquifer down-gradient of the ore zone would act as a barrier  Figure C-2.	Example Simulations with Flow Oriented Perpendicular to the Strike of the Ore Body; Kd=6e-6; Pump and Treat

Table C-2.	Simulation Results  Flow Direction Flow Field Kd (m3/gm) Retardation Factor Number of Time to Reach C<0.03 mg/ L (yr) Down gradient Travel Distance (m)

Injection Wells Pumping Wells

Parallel to length of deposit Ambient Flow 1.0E-06 11 0 0 >2200[a] >10000[a]

6.0E-06 61 0 0 >5000[b] >4800[b]

1.0E-05 100 0 0 >5000[b] >2800[b]

Pump and Treat 1.0E-06 11 20 9 50 0

6.0E-06 61 48 23 75 0

1.0E-05 100 60 29 100 0 Transverse to length of deposit Ambient Flow 1.0E-06 11 0 0 725 3300

6.0E-06 61 0 0 4750 3800

1.0E-05 100 0 0 >5000[b] >2800

Pump and Treat 1.0E-06 11 20 20 20 0

6.0E-06 61 36 36 60 0

1.0E-05 100 45 45 80 0 [a]	Plume exits simulation domain before decreasing below 0.03. [b]	Simulation ends before plume decreases below 0.03. to contaminant migration from the ore zone if re-mobilization occurs. In many cases, unmined down-gradient materials will maintain reducing conditions with sufficient capacity to immobilize a plume. The simulations in this appendix assume oxidizing conditions remain as the plume migrates down gradient. The consequences of re-mobilization illustrated in the simulations supports the use of a reasonably long post-restoration long-term stability monitoring period to provide an opportunity to detect any re-mobilization and address it before the contamination becomes widespread through the wellfield. The 30 yr post-restoration stability monitoring period in the proposed rule is aimed at providing at least an opportunity to detect re-mobilization if it begins to occur. The benefit of developing a geochemical model of the production zone aquifer is also illustrated by these assessments. If the geochemical reducing capacity of the restored wellfield and down-gradient portions of the production aquifer can be shown to minimize the potential for post-restoration remobilization of uranium, the regulator can terminate the license with confidence that the full thirty year monitoring period would not be necessary. Conversely, if the geochemical model of the system does not indicate a strong chemically reducing environment exists at the site, the regulatory agency can consider additional monitoring periods as necessary to verify that contamination is not moving out of the restored production zone area and potentially beyond the border of the wellfield aquifer. Developing a defensible geochemical model of the system can provide significant cost savings for all the alternative situations. If a strongly reducing environmental is present, costs can be lowered by early termination of the ISR license since re-mobilization is unlikely and the full 30 year monitoring period may not be required. If a less effective geochemical situation exists at an ISR site, standard restoration activities can be augmented to limit the potential for re-mobilization and monitoring efforts can be focused on detecting re-mobilization before it spreads over a wider area, thereby reducing the potential for incurring significant remediation costs. C.4	Estimated Costs of Remediation The simulation results described above for the pump and treat scenarios were then used to estimate the costs of remediating a plume of contamination that might result if conditions within a restored mine unit did not remain stable over time. The costs of remediation include the costs of the wells (installation and 20% replacement after 20 years) and the costs of treatment. Not explicitly included are costs of disposing of treated water since during the pump and treat operations, it is assumed that much of this will be re-injected; in addition, treated water could be evaporated from holding ponds or used for irrigation in these generally rural areas. None of these options would add significant costs. Also omitted from the costs are scoping assessments to identify the location and characteristics of the plume. In reality, such scoping would likely be needed to determine how to structure the pump and treat remediation. Omitting these costs means that our estimated costs of remediation may underestimate actual costs. This examination of the requirements and costs of remediating a plume of constituents at the CMU (under varying scenarios) is meant to illustrate the value of long-term stability monitoring. Clearly, the potential for remobilization, and creation of contaminant plumes, varies widely from site to site. EPA therefore did not attempt to generalize or extrapolate to estimate remediation requirements or costs that would be incurred at actual ISR sites. Instead, this is a CMU-specific example. Table C-3 presents the estimated costs of remediation. Annual O&M costs are a function of the number of wells (and thus, the estimated wellfield yield); they are estimated based on a unit cost of $6.35 per 1000 gallons (EPA, 2001) treated. Capital costs are also a function of the number of wells (and the estimated wellfield yield), and are computed based on $30.48 per thousand gallons (EPA, 2001) treated. It is assumed that, after 20 years, 20% of the wells will need to be replaced. Capital costs are annualized over a period of 20 years at 7% rate of interest. Total annualized costs are the sum of annual O&M costs and annualized capital costs for each scenario. Because higher Kd means the constituents are more difficult to remove (due to the tendency for the constituents to adhere to aquifer matrix material), both the number of wells and the duration of treatment increase as Kd increases under each scenario (transverse to the length of the deposit and along the length of the deposit). Also included in Table C-3 is a "short" remediation example, intended to represent the costs of using pump and treat methods to address increasing constituent concentrations detected in only a small area of the wellfield, approximately 20 acres. Fewer wells would be needed, and a shorter duration of treatment would be required to remediate the plume. This represents a lower-bound estimate of potential pump and treat remediation costs. Table C-3.	Estimated Costs of Remediation (Thousand $2011)

Kd No. of Wells Annual Wellfield Yield (1000 gal) Costs, $ Pumping Duration (years) Total Annualized Remediation Costs

Annual O & M Capital Annualized Total Capital

Transverse to length of deposit 1.0E-06                                       40 630,720 4,005 19,224  1,815 20 5,820

6.0E-06                                       72 1,135,296 7,209 34,604  3,266 60 10,475

1.0E-05                                       90 1,419,120 9,011 43,258  4,083 80 13,094 Along length of deposit 1.0E-06                                       29 457,272 2,904 13,938  1,316 50 4,219

6.0E-06                                       71 1,119,528 7,109 34,123  3,221 75 10,330

1.0E-05                                       89 1,403,352 8,911 42,774  4,038 100 12,949 Short 6.0E-06                                       10 157,680 1,001 4,806  454 30 1,455

Table C-4 summarizes the overall cost estimates. EPA estimated that contamination moving transverse to the length of the deposit would be detected in 6 years after restoration is complete, and that contamination moving along the length of the deposit would be detected after the site is decommissioned and the license terminated. In fact, a plume of contamination would be detected only if and when someone wishing to use groundwater in the area had it tested; the longer the time before the plume is detected, the more extensive the area of contamination is likely to be, and the more costly it would be to remediate, and greater is the possibility that humans or ecological receptors could be exposed to the constituents. If contamination does occur, and is detected long after license termination, the costs of remediation could fall on the taxpayer, rather than the owner/operator. Table C-4.	Summary of Estimated Remediation Costs, by Scenario and Kd (Millions $2011) Kd (m[3]/gm):  1.0E-06 6.0E-06 1.0E-05 Scenario: Transverse to the length of the ore deposit

Summed Costs $99.3 $481.0 $790.1 Scenario: Along the length of the ore deposit

Summed Costs $163.3 $586.1 $968.1 Scenario: Short, assumes small area of contamination is detected during long-term stability monitoring

Kd=6.0E-06

Summed Costs

$35.3

The summary provided below, for each remediation scenario and assumed Kd, shows that costs (either summed across the duration of the pump and treat remediation operations without discounting, or present values discounted at 3% or discounted at 7%) increase depending on the size of the plume, the direction of groundwater flow, and the Kd. Comparing the estimated total summed costs of pump and treat remediation for Kd=6.0E-06 m[3]/gm (under different scenarios) to the cost of complying with the proposed rule, including resuming restoration if contamination is discovered during long-term stability monitoring (see Table 4-1 for details) demonstrates the advantage of monitoring long enough to detect an upward trend in some constituents while the plume is still small so that re-mobilization can be detected and decisions made concerning treatment before the contamination becomes widespread and more expensive remedies are needed. C.5	References McDonald, M.G., and A.W. Harbaugh, 1983. A modular three-dimensional finite-difference ground-water flow model. Open-File Report 83-875. U.S. Geological Survey, December 28. McWorter, D.B. and D.K. Sunada, 2010. Ground-Water Hydrology and Hydraulics; Water Resources Publications, LLC; ISBN-10:<PHONE_NUMBER>; ISBN-13:<PHONE_NUMBER>612; 304 pages. Michel, T.G. and G. Hoffman, 1991. E-Field 50 Sand Mine Unit Hydrology Test, Highland Uranium Project, Power Resources, Inc.; Report for WDEQ/LQD Permit Number 603, U. S. Nuclear Regulatory Commission Docket Number 40-8857, SUA-1511; Report by Power Resources, Inc. and Hydro-Engineering; September 1990, revised July 1991. Pearson, F.J., Jr., C. J. Noronha and R.W. Andrews, 1983. "Mathematical Modeling of the Distribution of Natural 14-C, 234-U, and 238-U in a Regional Ground-Water System," Radiocarbon, Vol.25, No. 2, 1983, p 291-300. U.S. Environmental Protection Agency (EPA), 2001. Cost of Analysis for Selected Groundwater Cleanup Projects: Pump and Treat Systems and Permeable Reactive Barriers; U.S. EPA, Office of Solid Waste and Emergency Response; EPA Document No. 542-R-00-013; Exhibit 7, page 8, February. Zheng, C. and P.P. Wang, 1999. MT3DMS: A modular three-dimensional multispecies model for simulation of advection, dispersion and chemical reactions of contaminants in groundwater systems; Documentation and User's Guide, Contract Report SERDP-99-1, U.S. Army Engineer Research and Development Center, Vicksburg, MS.

APPENDIX D Sensitivity Analysis: Estimated Costs and Economic Impacts This Appendix presents results of a sensitivity analysis conducted to explore the uncertainty around costs of sampling. In Section 3, EPA presented the assumptions for each phase of ISR monitoring. These assumptions, shown in Tables 3-2 through 3-5, include a range of sampling and analysis costs. They also reflect estimated requirements under two regulatory alternatives and a "worst case" under which geochemical modeling does not provide assurance of future stability, and 30 years of long-term stability monitoring are required, in addition to geochemical modeling. As discussed in Section 3 above, EPA does not believe this "worst case" is likely to occur, because it would require that geochemical modeling conducted prior to the start of operations yields results that indicate that conditions would be stable long-term, but geochemical modeling conducted after operations have ended yields the opposite result. In reporting the results of the economic impact analysis in the main sections of this document, EPA focused on the proposed regulatory option; this appendix provides results for all the costing scenarios, under low, average, and high monitoring cost assumptions. Table D-1 presents estimated costs under each alternative and cost scenario. In general, the costs are lowest for the proposed regulatory alternative, which includes 30 years of long term stability monitoring, with the potential to shorten the duration if geochemical modeling indicates that geochemical conditions in the wellfield and especially down-gradient from the field will ensure that restored conditions will remain stable over time. Costs for the other regulatory alternative, which requires 30 years of long-term stability monitoring with no potential for shortening the duration, are slightly higher. Table D-1 also presents the "worst case" scenario, which assumes that the geochemical modeling does not provide assurance of stability, so that 30 years of long term stability monitoring is then required. As ex[ected, these costs are the highest. Table D-2 presents the results of a market model, which examines how the market for uranium (U3O8) would potentially be affected by the costs of complying with the regulation, under each alternative and costing scenario. The proposed regulatory alternative increases the cost of producing uranium by $1.30 to $1.70 per pound of U3O8. The 30-year long term stability monitoring with no potential to reduce duration causes the cost of uranium production to increase by an estimated $1.44 to $2.00 per pound. The "worst case" costing scenario causes the cost of uranium production to increase by $1.51 to $2.40 per pound. The lower the increase in the unit cost, the smaller the effect on the market. In all cases, the market price of U3O8 is projected to increase by less than the unit cost, domestic uranium production is projected to decline, and imports of uranium are projected to increase. Table D-1.	Estimated Facility and National Costs, by Costing Scenario (Thousand 2011$)

Low Average High Proposed Rule: 30-Year Long-term Stability Monitoring with Geochemical Modeling to Shorten Duration

ISR Operation

La Palangana $262 $304 $343 Alta Mesa $412 $477 $540 Willow Creek $510 $591 $668 Crow Butte $1,905 $2,205 $2,493  Smith Ranch-Highland-Reynolds $8,224 $9,521 $10,766  Lost Creek $317 $367 $415 Estimated Incremental National Costs

Total Annualized Cost $11,631 $13,465 $15,226 Total Cost, Summed across LOM $379,564 $431,284 $490,514 Present Value, 3% discount rate  $253,378 $289,991 $329,385 Present Value, 7% discount rate  $156,468 $181,135 $204,822 Required 30-Year Long-Term Stability Monitoring

ISR Operation

La Palangana $290 $340 $404 Alta Mesa $456 $534 $635 Willow Creek $565 $661 $786 Crow Butte $2,107 $2,468 $2,931  Smith Ranch-Highland-Reynolds $9,097 $10,657 $12,658  Lost Creek $351 $411 $488 Estimated Incremental National Costs

Total Annualized Cost $12,865 $15,072 $17,901 Total Cost, Summed across LOM $684,068 $814,903 $975,573 Present Value, 3% discount rate  $355,378 $419,826 $500,372 Present Value, 7% discount rate  $173,072 $202,754 $240,818                                                                     (continued)

Table D-1.	Estimated Facility and National Costs, by Costing Scenario (Thousand 2011$) (continued)

Low Average High Geochemical Modeling with 30-Year Long-Term Stability Monitoring

ISR Operation

La Palangana $305 $390 $484 Alta Mesa $480 $613 $761 Willow Creek $594 $759 $942 Crow Butte $2,217 $2,832 $3,516  Smith Ranch-Highland-Reynolds $9,571 $12,229 $15,182  Lost Creek $369 $472 $586 Estimated Incremental National Costs

Total Annualized Cost $13,536 $17,296 $21,472 Total Cost, Summed across LOM $15,145 $18,575 $22,642 Present Value, 3% discount rate  $7,999 $9,922 $12,157 Present Value, 7% discount rate  $3,960 $5,060 $6,281 Scaled up from CSM to national costs based on estimated total acreage. Table D-3 examines the ratio of the estimated costs incurred by companies owning ISR facilities to their revenues, to assess the potential financial impacts of complying with the rule on firms in the industry, especially small firms. For the two large firms, reported 2013 sales are used to estimate 2015 sales. Revenues for two small firms owning currently-operating ISR facilities are not publicly available. They are estimated based on the projected 2015 price of uranium ($57.00 per pound) and their estimated facility production in 2015. A third small firm is publicly traded (Uranium Energy); its 2013 sales are depressed due to market conditions; because we are projecting improved market conditions by 2015, we also estimate sales for this firm, based on estimated 2015 facility production and estimated market price.  The proposed regulatory alternative results in cost-to-sales ratios ranging from 0.1% to 1.9%, depending on the costing scenario. Even under the "worst case" costing scenario, costs are at most 2.7% of estimated company sales under the highest costing assumptions. Because costs are estimated to be less than 3.0% of company sales for the small businesses owning currently operating ISR facilities, and because EPA expects at most 10 small firms may be affected by the rule going forward, EPA concludes that the rule will not have a significant impact on a substantial number of small firms. Table D-2.	Estimated Market Impacts by Regulatory Alternative

With Regulation in Effect

Baseline Low Average High Proposed Rule: 30-Year Long-Term Stability Monitoring with Geochemical Modeling to Shorten Duration                                                                                Supply (1,000 pounds U3O8)                                                                         57,630                                                                          57,616                                                                          57,614                                                                          57,612  U.S. Origin (1,000 pounds U3O8)                                                                          9,451                                                                           9,089                                                                           9,032                                                                           8,977  ROW (1,000 pounds U3O8)                                                                         48,179                                                                          48,527                                                                          48,582                                                                          48,635  Demand (1,000 pounds U3O8)                                                                         57,630                                                                          57,616                                                                          57,614                                                                          57,612  Price ($/pound U3O8)                                                                         $57.00                                                                          $57.21                                                                          $57.24                                                                          $57.27  Change in Price                                                                                $0.21                                                                           $0.24                                                                           $0.27  Percentage Changes                                                                                Market Quantity                                                                                −0.02%                                                                        −0.03%                                                                        −0.03% U.S. Quantity                                                                                −3.8%                                                                         −4.4%                                                                         −5.0% Imports                                                                                0.7%                                                                            0.8%                                                                            0.9% Price                                                                                0.4%                                                                            0.4%                                                                            0.5% Compliance Cost per Pound                                                                                $1.30                                                                           $1.50                                                                           $1.70  Required 30-Year Long-Term Stability Monitoring                                                                                Supply (1,000 pounds U3O8)                                                                         57,630                                                                          57,615                                                                          57,612                                                                          57,609  U.S. Origin (1,000 pounds U3O8)                                                                          9,451                                                                           9,050                                                                           8,982                                                                           8,893  ROW (1,000 pounds U3O8)                                                                         48,179                                                                          48,564                                                                          48,631                                                                          48,715  Demand (1,000 pounds U3O8)                                                                         57,630                                                                          57,615                                                                          57,612                                                                          57,609  Price ($/pound U3O8)                                                                         $57.00                                                                          $57.23                                                                          $57.27                                                                          $57.32  Change in Price                                                                                $0.23                                                                           $0.27                                                                           $0.32  Percentage Changes                                                                                Market Quantity                                                                                −0.03%                                                                        −0.03%                                                                        −0.04% U.S. Quantity                                                                                −4.2%                                                                         −5.0%                                                                         −5.9% Imports                                                                                0.8%                                                                            0.9%                                                                            1.1% Price                                                                                0.4%                                                                            0.5%                                                                            0.6% Compliance Cost per Pound                                                                                $1.44                                                                           $1.68                                                                           $2.00                                                                      (continued) Table D-2.	Estimated Market Impacts by Regulatory Alternative (continued)

With Regulation in Effect

Baseline Low Average High Geochemical Modeling with 30-Year Long-Term Stability Monitoring                                                                                Supply (1000 pounds U3O8)                                                                         57,630                                                                          57,614                                                                          57,610                                                                          57,605  U.S. Origin (1000 pounds U3O8)                                                                          9,451                                                                           9,029                                                                           8,912                                                                           8,782  ROW (1000 pounds U3O8)                                                                         48,179                                                                          48,585                                                                          48,697                                                                          48,823  Demand (1000 pounds U3O8)                                                                         57,630                                                                          57,614                                                                          57,610                                                                          57,605  Price ($/pound U3O8)                                                                         $57.00                                                                          $57.24                                                                          $57.31                                                                          $57.38  Change in Price                                                                                $0.24                                                                           $0.31                                                                           $0.38  Percentage changes                                                                                Market Quantity                                                                                −0.03%                                                                        −0.04%                                                                        −0.04% U.S. Quantity                                                                                −4.5%                                                                         −5.7%                                                                         −7.1% Imports                                                                                0.8%                                                                            1.1%                                                                            1.3% Price                                                                                0.4%                                                                            0.5%                                                                            0.7% Compliance Cost per Pound                                                                                $1.51                                                                           $1.93                                                                           $2.40

Table D-3.	Estimated Company Cost-to-Sales Ratios by Regulatory Alternative

Estimated 2015 Sales (millions USD) Low Average High 30 Year with Geochemical Modeling

Parent Company

Cameco $2,400.0 0.4% 0.5% 0.6% Mestena $28.5 1.4% 1.7% 1.9% Uranium One $530.4 0.1% 0.1% 0.1% Uranium Energy $28.5 0.9% 1.1% 1.2% Ur-Energy $57.0 0.6% 0.6% 0.7% 30-Year Stability

Parent Company

Cameco $2,400.0 0.5% 0.5% 0.6% Mestena $28.5 1.6% 1.9% 2.2% Uranium One $530.4 0.1% 0.1% 0.1% Uranium Energy $28.5 1.0% 1.2% 1.4% Ur-Energy $57.0 0.6% 0.7% 0.9% Geochem with Required 30 Year

Parent Company

Cameco $2,400.0 0.5% 0.6% 0.8% Mestena $28.5 1.7% 2.2% 2.7% Uranium One $530.4 0.1% 0.1% 0.2% Uranium Energy $28.5 1.1% 1.4% 1.7% Ur-Energy $57.0 0.6% 0.8% 1.0%


[Federal Register Volume 76, Number 134 (Wednesday, July 13, 2011)]
[Notices]
[Pages 41266-41267]
[FR Doc No: 2011-17515]

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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2011-N-0012]

Critical Path Manufacturing Sector Research Initiative (U01)

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice.

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

SUMMARY: The Food and Drug Administration (FDA) is announcing the
availability of grant funds for the support of a cooperative agreement
with the National Institute for Pharmaceutical Technology and Education
Initiative (NIPTE).
    Development of the Critical Path Manufacturing Sector Initiative
has focused attention on the continuing need for this kind of research
in a way that can improve reliability of pharmaceutical product
manufacturing and quality across the entire industry. This shared
knowledge will increase the likelihood of successfully manufacturing
products that have been identified in the clinical development
community. The goal of this agreement is to improve the overall
manufacturing and quality and the knowledge base.

DATES: Important dates are as follows:
    1. The application due date is July 20, 2011.
    2. The anticipated start date is August 31, 2011.
    3. The opening date is July 13, 2011.
    4. The expiration date is July 22, 2011.
    For Further Information and Additional Requirements Contact:
    For Programmatic and Scientific Questions and Concerns contact:
    Jon Clark, Center for Drug Evaluation and Research, Food and Drug
Administration, 10903 New Hampshire Ave., Bldg. 51, rm. 4178, Silver
Spring, MD 20993,<PHONE_NUMBER>; E-mail<EMAIL_ADDRESS>    For Administrative and Financial Questions and Concerns contact:
Gladys Melendez, Office of Acquisitions and Grant Support, Food and
Drug Administration, 5630 Fishers Lane, rm. 1078, Rockville, MD 20857,
301-827-7175; E-mail<EMAIL_ADDRESS>    For more information on this funding opportunity announcement (FOA)
and to obtain detailed requirements, please refer to the full FOA
located at http://www.fda.gov/AboutFDA/CentersOffices/CDER/ucm088761.htm under the ``Regulatory Information'' section. The title
of the page is ``Research Acquisitions.''

SUPPLEMENTARY INFORMATION:

I. Funding Opportunity Description

    Funding Opportunity Number: RFA-FD-11-014.
    Catalog of Federal Domestic Assistance: 93.103.

A. Background

    The Office of Pharmaceutical Science has conducted research within
the academic community through contracts in order to improve the
overall manufacturing and quality knowledge base. This research is
important to the public sector, because research conducted in
pharmaceutical sciences related to product quality is typically kept
proprietary.
    Development of the Critical Path Manufacturing Sector Initiative
has focused attention on the continuing need for this kind of research
in a way that can improve reliability of pharmaceutical product
manufacturing and quality across the entire industry. This shared
knowledge will increase the likelihood of successful manufacturing.

B. Research Objectives

    The grant will support programs and research as described in the
following paragraphs, related to the manufacturing of drugs, biological
products, and medical devices:
     Education and training in the field of manufacturing and
scale-up, for product development partnerships, academic scientists,
other product developers and product application reviewers.
     Development of platform strategies and standardized
approaches for medical product manufacturing to shorten timelines for
manufacturers to produce quality medical products at commercial scale.
This will provide publicly available models for manufacturing and
scale-up that will help enable small firms to expeditiously market
important treatments.
     Development of analytical methodologies and advanced
computational methodologies to better characterize complex molecules
and complex mixtures of molecules is needed to better understand and
control manufacturing processes and product quality. Specific
analytical techniques will better enable standardized approaches to
manufacturing control and advance computational technologies will help
to identify atypical samples of complex molecules. These advances will
help assure pharmaceutical quality for the American public.
     Research into improved techniques for collection and
analysis of process data to control processes and to ensure that they
are in statistical control will be done. This includes science-based
flexible and adaptive approaches to manufacturing utilizing feed
forward and feed backward information flow. Standardized approaches to
assuring product quality using manufacturing and analytical data will
support continued product quality and lessen manufacturing failures
thus decreasing shortages of medically necessary products.
     Development of techniques for assuring product quality
using surrogates for desired clinical results will improve
understanding of quality target product profile. This approach takes
advantage of the potential to use existing clinical data to determine
clinically relevant specifications including unit-to-unit variability,
drug dissolution, and other material or product attributes, and to
support future manufacturing improvements while maintaining product
quality.
     Creating simulation models for manufacturing techniques
including but not limited to biotech fermentation and cell culture,
small molecule crystallization, freeze drying techniques, and precision
tablet coating will enhance industry knowledge. These models will
enable a more predictable approach to manufacturing development and
design of control systems. This predictability will shorten the
critical path pipeline from laboratory to clinic and support continual
improvement to achieve product quality of the drug's lifecycle.
     Creating simulation models for complex drug delivery
devices such as dry product inhalers, transdermal patches, and
liposomal products to better understand the product design and
performance and to control the critical manufacturing parameters. These
models will aid to speed the development of novel dosage forms and
decrease the failure rates of these products.
     Research into product formulation for special patient
populations or product formulation to ensure chemical stability of
active ingredients will shorten formulation development and

thus, the critical path pipeline. This research does not require
clinical or animal studies. Instead, it will lead to the creation of
materials with physical properties in materials that have been
previously identified as being desirable.
     Physical characteristics of active ingredients and
recipients in drug products, such as crystal morphology, co-crystal
technology, dispersions, and particle sizing including nanotechnology
are not fully developed in the public sector. This work will develop
technology enabling control of these attributes. This will provide
another dimension of control to the predictability of pharmaceutical
products. This added control will enable new approaches to
manufacturing novel dosage forms and shorten the time it takes to
develop manufacturing processes and controls.
     Development of specialized manufacturing techniques
suitable for products administered in low dosages and for products with
high toxicity or narrow therapeutic ranges. This will enable more rapid
development of manufacturing techniques for these products.
     Development of models for manufacturing and engineering of
device products such as infusion pumps, prosthetic organs,
defibrillators, tissue engineering devices, and combination products
will help standardize the approach for bringing these medical products
to market. This includes development of components for more reliable
delivery of pharmaceuticals to the most desirable site of action, for
example, controlling the air plume of inhaled products. This will
shorten the time required to move such products from concept to patient
and thereby shorten the Industrialization sector of the Critical Path.
     Research into methods for laboratory synthesis of
molecules that have been designed by computer simulation will shorten
medical product development time. These methods will make the creation
of these molecules more predictable. These technologies will also
enable new drug discoveries to be brought to market faster with less
variability; higher predictability of performance.
     Approaches to improve facilities where this research will
be conducted. Advanced technology development can be accelerated by
better design of the facilities where this research is conducted.
Creating and making these designs public will have the effect of
accelerating technology across the industry. This will shorten the time
it takes to bring these advanced technologies into the product
manufacturing sector.

C. Eligibility Information

    National Institute for Pharmaceutical Technology and Education
Initiative (NIPTE), a Nonprofit Other Than Institutions of Higher
Education, described in section 501(c)(3) of the Internal Revenue Code
of 1986 (26 U.S.C. 501(c)(3), which is exempt from tax under section
501(a) of that code.
    NIPTE is the only consortium of universities of its kind. The
organization consists of many of the most highly qualified
pharmaceutical manufacturing experts in academia. Research conducted by
NIPTE Faculty is collaborative by design to provide for coordinated
publication of the cutting-edge research results.
    An eligible organization that wishes to enter into a collaborative
agreement must provide an assurance that the entity will not accept
funding for a Critical Path Public-Private Partnership Project from any
organization that manufactures or distributes products regulated by FDA
unless the entity provides assurance in its agreement with FDA that the
results of the Critical Path Public Partnership project will not be
influenced by any source of funding. The entities eligible to enter
into partnerships with FDA are governed by section 566 of the Federal
Food, Drug, and Cosmetic Act (21 U.S.C. 360bbb5).
    This cooperative agreement will provide continued support for
established and previously funded collaborations on behalf of FDA
priorities.

II. Award Information/Funds Available

A. Award Amount

    Only one grant will be awarded. In fiscal year 2011, there is
currently $700,000 available. As funds are available, partner
components may supplement up to $7,000,000 total cost per year,
depending on the availability of fiscal year funds.

B. Length of Support

    Application budgets are not limited, but need to reflect actual
needs of the proposed project. This Cooperative Agreement is capable of
awarding a total of $35,000,000 over the entire award project period
depending upon progress, the need for, and the availability of fiscal
year funds.

III. Paper Application, Registration, and Submission Information

    To submit a paper application in response to this FOA, applicants
should first review the full announcement located at http://www.fda.gov/AboutFDA/CentersOffices/CDER/ucm088761.htm located under
the ``Regulatory Information'' section. The title of the page is
``Research Acquisitions.''
    Persons interested in applying for a grant may obtain an
application at http://grants.nih.gov/grants/forms.htm. For all paper
application submissions, the following steps are required:
     Step 1: Obtain a Dun and Bradstreet (DUNS) Number.
     Step 2: Register With Central Contractor Registration.
     Step 3: Register With Electronic Research Administration
(eRA) Commons.
    Steps 1 and 2, in detail, can be found at: http://www07.grants.gov/applicants/organization_registration.jsp. Step 3, in detail, can be
found at https://commons.era.nih.gov/commons/registration/registrationInstructions.jsp. After you have followed these steps,
submit paper applications to Gladys Melendez, Grants Management
Officer/Grants Management Specialist (see For Further Information and
Additional Requirements Contact).

    Dated: July 7, 2011.
Leslie Kux,
Acting Assistant Commissioner for Policy.
[FR Doc. 2011-17515 Filed 7-12-11; 8:45 am]
BILLING CODE 4160-01-P


[Federal Register Volume 76, Number 47 (Thursday, March 10, 2011)]
[Notices]
[Pages 13177-13178]
[FR Doc No: 2011-5485]

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

DEPARTMENT OF ENERGY

Federal Energy Regulatory Commission

[Docket No. CP11-25-000]

Questar Pipeline Company; Notice of Availability of the
Environmental Assessment for the Proposed Mainline 104 Extension to
Fidlar Project

    The staff of the Federal Energy Regulatory Commission (FERC or
Commission) has prepared an environmental assessment (EA) for the
Mainline 104 Extension to Fidlar Project (Project) proposed by Questar
Pipeline Company (Questar) in the above-referenced docket. Questar
requests authorization to extend its existing Mainline 104 pipeline
eastward by constructing, operating, and maintaining a natural gas
transmission pipeline and ancillary facilities between Questar's Green
River Block Valve and its Fidlar Compressor Station located in Uintah
County, Utah. The purpose of the Project is to allow shippers greater
access to Uinta basin natural gas supplies near the Fidlar Compressor
Station.
    The EA assesses the potential environmental effects of the
construction and operation of the Project in accordance with the
requirements of the National Environmental Policy Act of 1969 (NEPA).
The FERC staff concludes that approval of the proposed project, with
appropriate mitigating measures, would not constitute a major federal
action significantly affecting the quality of the human environment.
    The U.S. Bureau of Indian Affairs (BIA), U.S. Bureau of Land
Management (BLM), U.S. Fish and Wildlife Service, and Utah Public Lands
and Policy Coordination Office participated as cooperating agencies in
the preparation of the EA. Cooperating agencies have jurisdiction by
law or special expertise with respect to resources potentially affected
by the proposal and participate in the NEPA analysis. The BIA and BLM
will adopt and use the EA to consider the issuance of a right-of-way
grant for the portion of the Project on tribal and federal lands,
respectively.
    Questar's proposed Project includes the following facilities:
     About 24.6 miles of 24-inch-diameter natural gas
transmission pipeline;
     Three mainline block valves at mileposts (MP) 8.5, 14.5,
and 24.6;
     One pig launcher/receiver at the Fidlar Compressor
Station;
     Eight underground pipeline taps at MPs 3.1, 5.4, 6.3, 8.5,
12.7, 13.3, 16.9, and 20.9; and
     A measurement and control facility within the Fidlar
Compressor Station.
    The EA has been placed in the public files of the FERC and is
available for public viewing on the FERC's Web site at http://www.ferc.gov using the eLibrary link. A limited number of copies of the
EA are available for distribution and public inspection at: Federal
Energy Regulatory Commission, Public Reference Room, 888 First Street
NE., Room 2A, Washington, DC 20426,<PHONE_NUMBER>.
    Copies of the EA have been mailed to federal, state, and local
government representatives and agencies; elected officials;
environmental and public interest groups; Native American tribes; other
interested individuals and groups; newspapers and libraries in the
project area; and parties to this proceeding.
    Any person wishing to comment on the EA may do so. Your comments
should focus on the potential environmental effects, reasonable
alternatives, and measures to avoid or lessen environmental impacts.
The more specific your comments, the more useful they will be. To
ensure that your comments are properly recorded and considered prior to
a Commission decision on the proposal, it is important that the FERC
receives your comments in Washington, DC on or before April 4, 2011.
    For your convenience, there are three methods you can use to submit
your comments to the Commission. In all instances, please reference the
project docket number (CP11-25-000) with your submission. The
Commission encourages electronic filing of

comments and has dedicated eFiling expert staff available to assist you
at<PHONE_NUMBER> or<EMAIL_ADDRESS>    (1) You may file your comments electronically by using the eComment
feature, which is located on the Commission's Web site at http://www.ferc.gov under the link to Documents and Filings. An eComment is an
easy method for interested persons to submit brief, text-only comments
on a project;
    (2) You may file your comments electronically by using the eFiling
feature, which is located on the Commission's Web site at http://www.ferc.gov under the link to Documents and Filings. With eFiling, you
can provide comments in a variety of formats by attaching them as a
file with your submission. New eFiling users must first create an
account by clicking on ``eRegister.'' You will be asked to select the
type of filing you are making. A comment on a particular project is
considered a ``Comment on a Filing''; or
    (3) You may file a paper copy of your comments at the following
address: Kimberly D. Bose, Secretary, Federal Energy Regulatory
Commission, 888 First Street, NE., Room 1A, Washington, DC 20426.
    Although your comments will be considered by the Commission, simply
filing comments will not serve to make the commenter a party to the
proceeding. Any person seeking to become a party to the proceeding must
file a motion to intervene pursuant to Rule 214 of the Commission's
Rules of Practice and Procedures (18 CFR 385.214).\1\ Only intervenors
have the right to seek rehearing of the Commission's decision.
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    \1\ Interventions may also be filed electronically via the
Internet in lieu of paper. See the previous discussion on filing
comments electronically.
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    Affected landowners and parties with environmental concerns may be
granted intervenor status upon showing good cause by stating that they
have a clear and direct interest in this proceeding which would not be
adequately represented by any other parties. You do not need intervenor
status to have your comments considered.
    Additional information about the project is available from the
Commission's Office of External Affairs, at (866) 208-FERC or on the
FERC Web site (http://www.ferc.gov) using the eLibrary link. Click on
the eLibrary link, click on ``General Search'' and enter the docket
number excluding the last three digits in the Docket Number field
(i.e., CP11-25). Be sure you have selected an appropriate date range.
For assistance, please contact FERC Online Support at
<EMAIL_ADDRESS>or toll free at<PHONE_NUMBER>, or for TTY,
contact<PHONE_NUMBER>. The eLibrary link also provides access to the
texts of formal documents issued by the Commission, such as orders,
notices, and rulemakings.
    In addition, the Commission offers a free service called
eSubscription which allows you to keep track of all formal issuances
and submittals in specific dockets. This can reduce the amount of time
you spend researching proceedings by automatically providing you with
notification of these filings, document summaries, and direct links to
the documents. Go to http://www.ferc.gov/esubscribenow.htm.

    Dated: March 4, 2011.
Kimberly D. Bose,
Secretary.
[FR Doc. 2011-5485 Filed 3-9-11; 8:45 am]
BILLING CODE 6717-01-P


[Federal Register: April 26, 2006 (Volume 71, Number 80)]
[Notices]
[Page 24669-24670]
[DOCID:fr26ap06-63]

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DEPARTMENT OF ENERGY

Federal Energy Regulatory Commission

Combined Notice of Filings  1

April 19, 2006.
    Take notice that the Commission received the following electric
securities filings.

    Docket Numbers: ES06-32-000.
    Applicants: Cambridge Electric Light Company.
    Description: Cambridge Electric Light Co. submits its section 204
application for authority to issue short-term debt securities from time
to time, in amounts such that the aggregate principal amount of
securities outstanding at one time, shall not exceed $80,000,000.
    Filed Date: 4/5/2006.
    Accession Number: 20060412-0109.
    Comment Date: 5 p.m. eastern time on Wednesday, April 26, 2006.

    Docket Numbers: ES06-33-000.
    Applicants: Boston Edison Company.
    Description: Boston Edison Co. submits its section 204 application
for authority to issue short-term debt securities for time to time in
amounts such that the aggregate principal amount of short-term
securities outstanding at any one time, shall not exceed $450,000,000.
    Filed Date: 4/5/2006.
    Accession Number: 20060412-0072.
    Comment Date: 5 p.m. eastern time on Wednesday, April 26, 2006.

    Docket Numbers: ES06-34-000.
    Applicants: Commonwealth Electric Company.
    Description: Commonwealth Electric Co. submits its section 204
application for authority to issue short-term debt securities from time
to time, in amount not to exceed $125,000,000.
    Filed Date: 4/5/2006.
    Accession Number: 20060412-0073.
    Comment Date: 5 p.m. eastern time on Wednesday, April 26, 2006.

    Docket Numbers: ES06-35-000; EC06-110-000.
    Applicants: Entergy Services Inc.
    Description: Entergy Services Inc., on behalf of its associate
companies: Entergy Nuclear Generation Co. et al. submits a joint
application pursuant to sections 204(a) and 203(a) of the FPA.
    Filed Date: 4/6/2006.
    Accession Number: 20060417-0198.
    Comment Date: 5 p.m. eastern time on Thursday, April 27, 2006.
    Any person desiring to intervene or to protest in any of the above
proceedings must file in accordance with Rules 211 and 214 of the
Commission's Rules of Practice and Procedure (18 CFR 385.211 and
385.214) on or before 5 p.m. eastern time on the specified comment
date. It is not necessary to separately intervene again in a subdocket
related to a compliance filing if you have previously intervened in the
same docket. Protests will be considered by the Commission in
determining the appropriate action to be taken, but will not serve to
make protestants parties to the proceeding. Anyone filing a motion to
intervene or protest must serve a copy of that document on the
Applicant. In reference to filings initiating a new proceeding,
interventions or protests submitted on or before the comment deadline
need not be served on persons other than the Applicant.
    The Commission encourages electronic submission of protests and
interventions in lieu of paper, using the FERC Online links at http://www.ferc.gov.
 To facilitate electronic service, persons with Internet

access who will eFile a document and/or be listed as a contact for an
intervenor must create and validate an eRegistration account using the
eRegistration link. Select the eFiling link to log on and submit the
intervention or protests.
    Persons unable to file electronically should submit an original and
14 copies of the intervention or protest to the Federal Energy
Regulatory Commission, 888 First St. NE., Washington, DC 20426.
    The filings in the above proceedings are accessible in the
Commission's eLibrary system by clicking on the appropriate link in the
above list. They are also available for review in the Commission's
Public Reference Room in Washington, DC. There is an eSubscription link
on the Web site that enables subscribers to receive e-mail notification
when a document is added to a subscribed dockets(s). For assistance
with any FERC Online

service, please e-mail<EMAIL_ADDRESS>or call (866) 208-
3676 (toll free). For TTY, call<PHONE_NUMBER>.

Magalie R. Salas,
Secretary.
[FR Doc. E6-6234 Filed 4-25-06; 8:45 am]

BILLING CODE 6717-01-P