The additional supplemental measurements of speciated NOy, continuous SO2 and NHx will be used in future air quality modeling evaluation efforts.  Because there often is significant lag in the availability of contemporary emissions data to drive air quality modeling, the complete use of these data sets will extend beyond the five-year collection period of the pilot program.  Consequently, the immediate application of those data will address instrument performance comparisons that explore the feasibility of using continuous SO2 instruments in rural environments, and using the speciated NOy data to assess NOy instrument performance.   Although contemporary air quality modeling will lag behind measurement data availability, the observations can be used in deposition models to compare observed transference ratios with the previously calculated transference ratios to test temporal stability of the ratios.
      An extended water quality sampling effort should parallel the air quality measurement program to address some of the uncertainties related to factor F1 and the representativeness of the n[th] percentile critical load as discussed in section III.B.5.b.i.  The objective of the water quality sampling would be to develop a larger data base of critical loads in each of the pilot ecoregions such that the n[th] percentile can adequately be characterized in terms of representing all water bodies.  Opportunities to leverage and perhaps enhance existing ecosystem modeling efforts enabling more advanced critical load modeling and improved methods to estimate base cation production would be pursued.  For example, areas with ongoing research studies producing data for dynamic critical load modeling would be considered when selecting the pilot ecoregions.
4.	Complementary areas of research
      The EPA recognizes that a source of uncertainty in an AAI-based secondary standard that would not be directly addressed in the pilot program stems from the uncertainty in the model used to link atmospheric concentrations to dry deposition fluxes.  Currently, there are no ongoing direct dry deposition measurement studies at CASTNET sites that can be used to evaluate modeled results.  It was strongly recommended by CASAC AMMS that a comprehensive sampling-intensive study be conducted in at least one, preferably two sites in different ecoregions to assess characterization of dry deposition of sulfur and nitrogen.  These sites would be the same as those for the complementary measurements described above, but they would afford an opportunity to also complement dry deposition process research that benefits from the ambient air measurements collected in the pilot program.  The concerns regarding uncertainties underlying an AAI-based secondary standard suggests that research that includes dry deposition measurements and evaluation of dry deposition models should be a high priority.
      Similar leveraging should be pursued with respect to ecosystem research activities.  For example, studies that capture a suite of soil, vegetation, hydrological, and water quality properties that can help evaluate more advanced critical load models would complement the atmospheric-based pilot program.  In concept, such studies could provide the infrastructure for true multi-pollutant, multi-media "super" sites assuming the planning, coordination, and resource facets can be aligned.  While this discussion emphasizes the opportunity of leveraging ongoing research efforts, consideration could be given to explicitly including related research components directly in the pilot program.
5.	Implementation challenges
	The CAA requires that once a NAAQS is established, designation and implementation must move forward.  With standard as innovative as the AAI-based standard considered in this review, the Administrator believes that its success will be greatly improved if, while additional data are being collected to reduce the uncertainties discussed above, the implementing agencies and other stakeholders have an opportunity to discuss and thoroughly understand how such a standard would work.   And since, as noted above, emissions reductions that are directionally correct to reduce aquatic acidification will be occurring as a result of other CAA programs, the Administrator believes that this period of further discussion will not delay progress but will ensure that once implementation is triggered, agencies will be prepared to implement it successfully.
      Consideration of an AAI-based secondary standard for oxides of nitrogen and sulfur would present significant implementation challenges because it involves multiple, regionally-dispersed pollutants and relatively complex compliance determinations.  The anticipated implementation challenges fall into three main categories:  monitoring and compliance determinations for area designations, pre-construction permit application analyses of individual source impacts, and State Implementation Plan (SIP) development.  Several overarching implementation questions that we anticipate will be addressed in parallel with the field pilot program's five-year data collection period include:
      (1)  What are the appropriate monitoring network density and siting requirements to support a compliance system based on ecoregions?
      (2)  Given the unique spatial nature of the secondary standard (e.g., ecoregions), what are the appropriate parameters for establishing nonattainment areas?
      (3)  How can new or modified major sources of oxides of nitrogen and oxides of 	sulfur emissions assess their ambient impacts on the standard and demonstrate that they are not causing or contributing to a violation of the NAAQS for preconstruction permitting?
      (4)  What additional tools, information, and planning structures are needed to assist states with SIP development, including the assessment of interstate pollutant transport and deposition?
      (5)  Would transportation conformity apply in nonattainment and maintenance areas for this secondary standard, and, if it does, would satisfying requirements that apply for related primary standards (e.g., ozone, PM2.5, and NO2) be demonstrated to satisfy requirements for this secondary standard?
6.	Final monitoring plan development and stakeholder participation
      The existing CASTNET sampling site infrastructure provides an effective means of quickly and efficiently deploying a monitoring program to support potential implementation of an AAI-based secondary standard, and also provides an additional opportunity for federally managed networks to collaborate and support the states, local agencies and Tribes (SLT) in determining compliance with a secondary standard.  A collaborative effort would help to optimize limited federal and SLT monitoring funds and would be beneficial to all involved.  CASTNET is already a stakeholder-based program with over 20 participants and contributors, including federal, state and tribal partners.  CASTNET partners are willing to adapt the network to meet the monitoring requirements of an AAI-based secondary standard, provided the current requirements for program assessment continue to be met.
          The CASAC AMMS generally endorsed the technical approaches used in CASTNET, but concerns were raised by individual representatives of State agencies concerning the perception of EPA-controlled management aspects of CASTNET and data ownership. Potential approaches to resolve these issues will be developed and evaluated in existing NACAA/EPA ambient air monitoring workgroups.  The EPA Office of Air and Radiation (which includes the Office of Air Quality Planning Standards, OAQPS; and the Office of Atmospheric Program's Clean Air Markets Division, OAP-CAMD), and their partners on the NACAA monitor steering committee will develop a prioritized specific plan that identifies the 3-5 ecoregions and the instrumentation to be deployed.  EPA anticipates that a cost estimate of the plan with priorities and options will be developed by January, 2012.   Although this pilot program is focused on data collection, the plan will include details of the data analysis approaches as well as a vehicle that incorporates engagement from those within EPA and SLTs to foster progress on the implementation questions noted above in section IV.A.5.
      If an AAI-based secondary standard were to be set in the future, deployment of a full national network would follow the pilot monitoring program.  The number of sites deployed in the network will lead to increased confidence in capturing spatial patterns of air quality.  Recognizing that this section presents the general elements of the field pilot programs, EPA intends to develop a more detailed field pilot program plan through a process that will engage the air quality management and research (atmospheric and ecosystem) communities, as well as other federal agencies, state and local agencies, and non-government based centers of expertise.  The EPA is seeking comment and input on all aspects of this field pilot program.
.B.	Evaluation of Monitoring Methods
      The EPA generally relies on monitoring methods that have been designated as FRMs or FEMs for the purpose of determining the attainment status of areas with regard to existing NAAQS.  Such FRMs or FEMs are generally required to measure the air quality indicators that are compared to the level of a standard to assess compliance with a NAAQS.  Prior to their designation by EPA as FRM/FEMs through a rulemaking process, these methods must be determined to be applicable for routine field use and need to have been experimentally validated by meeting or exceeding specific accuracy, reproducibility, and reliability criteria established by EPA for this purpose.  As discussed above in section III.A, the ambient air indicators being considered for use in an AAI-based standard include SO2, particulate sulfate (p-SO4), and total reactive oxides of nitrogen (NOy).
      The CASTNET provides a well established infrastructure that would meet the basic location and measurement requirements of an AAI-based secondary standard given the rural placement of sites in acid sensitive areas.  In addition, CFPs currently provide very economical weekly, integrated average concentration measurements of SO2, p-SO4, ammonium ion (NH4) and t-NO3, the sum of HNO3 and p-NO - 3.
      While routinely operated instruments that measure SO2, p-SO4, NOy and/or t-NO3 exist, instruments that measure p-SO4, NOy, t-NO3, or the CFP SO2 have not been designated by EPA as FRMs or FEMs   The EPA's ORD has initiated work that will support future FRM designations by EPA for SO2 and p-SO4 measurements based on the CFP.  Such a designation by EPA could be done for the purpose of facilitating consistent research related to an AAI-based standard and/or in conjunction with setting and supporting an AAI-based secondary standard.
      Based on extensive review of literature and available data, the EPA has identified potential methods that appear suitable for measuring each of the three components of the indicators.  These three methods are being considered as new FRMs to be used for measuring the ambient concentrations of the three components that would be needed to determine compliance with an AAI-based secondary standard.
      For the SO2 and p-SO4 measurements, EPA is considering the CFP method, which provides weekly average concentration measurements for SO2 and p-SO4.  This method has been used in the EPA's CASTNET monitoring network for 15 years, and strongly indicates that it will meet the requirements for use as an FRM for the SO2 and p-SO4 concentrations for an AAI-based secondary standard.
      Although the CFP method would provide measurements of both the SO2 and p-SO4 components in a unified sampling and analysis procedure, individual FRMs will be considered for each.  The EPA recognizes that an existing FRM to measure SO2 concentrations using ultra-violet fluorescence (UVF) exists (40 CFR Part 50, Appendix A-1) for the purpose of monitoring compliance for the primary SO2 NAAQS.  However, several factors suggest that the CFP method would be superior to that UVF FRM for monitoring compliance with an AAI-based secondary standard and will be discussed in more detail below.
	For monitoring the NOy component, a continuous analyzer for measuring NOy is commercially available and is considered to be suitable for use as an FRM.  This method is similar in design to the existing NO2 FRM (described in 40 CFR Part 50, Appendix F), which is based on the ozone chemiluminescence measurement technique.  The method is adapted to and further optimized to measure all oxides of nitrogen (NOy).  However, this NOy method requires further evaluation before it can be fully confirmed as a suitable FRM.  The EPA is currently completing a full scientific assessment of the NOy method to determine whether it would be appropriate to consider for designation by EPA as an FRM.  Specific details on these three methods are given below.
             On February 16, 2011, EPA presented this set of potential FRMs to the CASAC AMMS for their consideration and comment.  In response, the CASAC AMMS stated that, overall, it believes that EPA's planned evaluation of methods for measuring NOy, SO2 and p-SO4 as ambient air indicators are suitable approaches in concept.   On supporting the CFP method as a potential FRM for SO2, CASAC stated that they felt that the CFP is adequate for measuring long-term average SO2 gas concentrations in rural areas with low levels (less than 5 ppbv) and is therefore suitable for consideration as an FRM.  For p-SO4, CASAC generally supports the use of the CFP as a potential FRM for measuring p-SO4 for an AAI-based secondary standard.  The method has been relatively well-characterized and evaluated, and it has a documented, long-term track record of successful use in a field network designed to assess spatial patterns and long-term trends.
      On supporting the photometric NOy method as a potential FRM, CASAC concluded that the existing NOy method is generally an appropriate approach for the indicator.  However, CASAC agrees that additional characterization and research is needed to fully understand the method in order to designate it as a FRM.  The EPA is now soliciting public comment on these methods as to their adequacy, suitability, and relative merits as FRMs for purposes of monitoring to determine compliance with an AAI-based secondary standard.
1.	Potential FRMs for SO2 and p-SO4
      The CFP is a combined, integrated sampling and analysis method based on the well-established measurement technology that has been used extensively in EPA's CASTNET monitoring network (see http://www.epa.gov/castnet).  This method is in current use at over 80 monitoring sites and has been in use at not less than 40 sites for over 15 years.  This method employs a relatively simple and inexpensive sampler and uses four 47-mm filters placed in an open-faced filter pack to simultaneously collect integrated filter samples for the SO2 and p-SO4 components.  In addition, the CFP is also capable of the collection of t-NO3, the sum of HNO3 and p-NO3.
      The first stage of the filter pack assembly contains a Teflon(R) filter that collects p-SO4[2-] and p-NO3, the second stage contains a nylon filter that collects SO2 (as SO4[2-]) and HNO3, and the third stage contains two cellulose fiber filters impregnated with potassium carbonate (K2CO3) that collect any remaining SO2 (as SO4[2-]).  The sampler collects one-week integrated samples at a very low, controlled flow rate (1.5 or 3 L/min) in an attempt simulate actual deposition.  Weekly averaged SO2 and p-SO4 concentrations could then be averaged over a 1-year period to calculate annual average values.
      Upon sample completion, the species-specific filters are extracted, with subsequent analysis by the well-established and documented ion chromatographic (IC) analytical technique. During the IC analysis, an aliquot of a filter extract is injected into a stream of eluent (ion chromatography mobile phase, generally a millimolar-strength solution of carbonate-bicarbonate) and passed through a series of ion exchangers.  The anions of interest are separated on the basis of their relative affinities for a low capacity and the strongly basic anion exchanger (guard and separator column).  The separated anions are directed onto a cation exchanger (suppressor column) where they are converted to their highly conductive acid form, and the eluent is converted to a weakly conductive form.  The now-separated anions, each in their acid form, are measured by conductivity.  They are identified on the basis of retention time compared to that of standards and quantified by measurement of peak area compared to the peak areas of calibration standards.
      Calibration and quality assurance for the method are applied to the sample filters, the analytical processes, and the flow rate measurement and control aspects of the sampler.  Overall method performance is typically assessed with collocated samplers.  These quality assurance techniques are routinely used and have proved adequate for other types of FRMs and equivalent methods in air monitoring network service.
      The measurement and analytical procedures and past performance data associated with the CFP method are well documented and available through Quality Assurance Performance Plans (QAPPs), Standard Operating Procedures (SOPs) and annual reports (US EPA, 2010a and 2010b).  The accumulated database on the CFP method is substantial and indicates that the method is sound, stable and has good reliability in routine, field operation.  Data quality assessment results show the method to have good reproducibility, with collocated and analytical precision values in the range of 2%  -  10% (excluding very low concentration measurements near the method detection limits; US EPA 2010b).
      Data quality objectives (DQOs) for a new FRM would be based upon current DQOs being used for this method by EPA's OAP/CAMD and the National Park Service (NPS), the federal managers of CASTNET (US EPA, 2010a).  In its current state, the CFP method is expected to meet or exceed (as past CASTNET data have indicated; US EPA, 2010b) the expected FRM DQOs, even when deployed in new monitoring networks outside of CASTNET.  In addition, CASTNET samples have agreed favorably with other measures of SO2 and p-SO4 in comparison studies.  For example, in direct comparison with an annular denuder sampler (ADS) method, CASTNET/ADS ratios for SO2 and p-SO4 were generally on the order of 0.9-1.1 (Lavery et al, 2009; Sickles et al, 1999; Sickles et al, 2008), thus illustrating the accuracy of the CFP method in the determination of long-term average SO2 and p-SO4 concentrations.  The EPA believes that the CFP method would be fully adequate as an FRM in determining yearly average SO2 and p-SO4 concentrations for compliance determination purposes.
      The EPA recognizes that an existing FRM for SO2 has proven adequate for the purposes of monitoring compliance for the primary SO2 NAAQS, specifically the newly-promulgated 1-hour standard.  However, this FRM is better suited to the shorter-term, higher concentration primary and secondary SO2 NAAQS, and there is substantial uncertainty as to the adequacy of this SO2 FRM for monitoring the lower concentrations relevant to determining compliance with an AAI-based secondary standard.  The performance specifications for SO2 FRM analyzers (40 CFR Part 53, Table B-1) require a lower detectable limit (LDL) of 0.002 ppm for the standard measurement range and 0.001 ppm for the lower measurement range.  These requirements correspond to mass per unit volume concentrations of 5.24 and 2.62 ug/m[3], respectively.   Analysis of 2009 CASTNET data shows that of the 84 CASTNET sampling sites, 63 measured annual average SO2 concentrations below even the lower of these LDL requirements of 2.62 ug/m[3] for the lower range SO2 FRM (US EPA, 2010a).  In addition, 11 of the 84 sites measured annual (2009) average SO2 concentrations very near or below the manufacturers' reported detection limits for trace level UVF SO2 monitors.  Further, it is likely that the number of sites with annual average SO2 concentration below both the SO2 FRM LDL and the manufacturers reported detection limits will increase due to expected declines in mean SO2 concentrations (US EPA, 2010b). For these reasons, EPA is considering the CFP method for use as the FRM for monitoring the SO2 component of an ambient air indicator for oxides of sulfur, with a recommendation for additional study and data collection to further evaluate the possible applicability of the continuous UVF SO2 FRM for this purpose.
2.	Potential FRM for NOy
       Atmospheric concentrations of NOy are measured continuously by an analyzer that photometrically measures the light intensity, at wavelengths greater than 600 nanometers (nm), resulting from the chemiluminescent reaction of ozone (O3) with NO in sampled air.  This method is very similar to the chemiluminescence NO/NO2 analyzers widely used to collect NO2 monitoring data for determining compliance with the NO2 NAAQS.  The various oxides of nitrogen species, excluding NO, are first quantitatively reduced to NO by means of a catalytic converter.  These species include NO2, HNO2, PANs, HNO3 and p-NO3.  The NO, which commonly exists in ambient air, passes through the converter unchanged, and, when combined with the NO resulting from the catalytic conversion of the other oxides of nitrogen, a measurement of the total NOy concentration results.  To maximize the conversion of the more chemically active oxides of nitrogen species, the converter is located externally, at or near the air sample inlet probe.  This location minimizes losses of these active species that could otherwise occur from chemical reactions and wall losses in the sample inlet line.
      The NOy analyzer is a suitable, commercially produced continuous chemiluminescence analyzer that includes an ozone generator, a reaction cell, a photometric detector, wavelength filters as necessary to reduce sensitivity to wavelengths below 600 nm, a pump and flow control system to draw atmospheric air through the converter and into the reaction cell, a suitable converter, a system to control the operation of the analyzer, and appropriate electronics to process and quantitatively scale the photometric signals.  The converter contains a catalyst such as molybdenum and is heated to an optimum temperature designed to optimize the conversion of the various oxides of nitrogen to NO.  It is connected to the analyzer via suitable lengths of Teflon(R) tubing.  Hourly NOy measurements obtained by the analyzer would be averaged over the same 7-day period used by the CFP method to measure the SO2 and p-SO4 components, with further averaging over a 1-year period.
      Commercial NOy analyzers are currently available, and the analyzers have been used for a variety of monitoring applications.  During the 2006 TexAQS Radical and Aerosol Measurement Project (TRAMP), Luke et. al., 2010, compared measured NOy concentrations obtained with an NOy instrument based upon the above mentioned methodology with the sum of measured individual NOy species (i.e., NOyi = NO+NO2+HNO3+PANs+HNO2+p-NO3).  This comparison yielded excellent overall agreement during both day ([NOy](ppb) = [NOyi](ppb) x 1.03  -  0.42; r[2] = 0.9933) and night time ([NOy](ppb) = [NOyi](ppb) x 1.01  -  0.18; r[2] = 0.9975) periods (Luke et al, 2010).  The results of this study show that this NOy method is capable of the accurate determination of all the atmospherically relevant NOy components, resulting in an accurate determination of total NOy concentrations.  NOy instruments have been routinely operated in networks such as SEARCH, dating back several years.  In addition, state monitoring agencies across the U.S. have begun, starting in 2009, the routine operation of commercially available NOy instrumentation in anticipation of EPA's NCore network transitioning to full operation in 2011.
      These initial assessments described above are promising and indicate that the photometric NOy method appears to be accurate, reliable, and capable of routine network operation.  As a result, the method is most likely capable for use as an FRM for determining atmospheric NOy concentrations as a component in determining compliance with an AAI-based secondary standard.  However, as described below, this continuous method for NOy requires additional time for further evaluation before it can be fully confirmed for adoption as a FRM.  The EPA has identified measurement uncertainties and some remaining science questions associated with this method.  Among these are (a) the ability of the method to capture all components of NOy relevant to nitrogen deposition, (b) the efficiency of the molybdenum converter in converting all oxides of nitrogen to NO for detection (excluding NO2, as this conversion is already well documented), (c) appropriate inlet height specifications to minimize any bias associated with vertical concentration gradients of key NOy components, (d) identification and quantification of potential measurement interferences in the NOy determination, and (e) development and demonstration of effective calibration/challenge procedures to best represent the various mixtures of NOy components that are expected to be present in the different air sheds across the U.S.
      To address these NOy method uncertainties and to fully assess this method for use as the NOy FRM, EPA has developed a detailed research plan (Russell and Samet, 2011b) which was presented to the CASAC AMMS on February 16, 2011.  In response, CASAC recognized the need for, and supported the general outline of EPA's research plan to evaluate the NOy method for potential designation as an FRM (US EPA, 2011).  In addition, the CASAC AMMS suggested additional areas of research associated with the photometric NOy method that warrant further assessment prior to final designation of the method as the NOy FRM.  These include operation of the method during extremely low temperature conditions to investigate possible condensation in sample lines, method detection limits relative to low levels expected in remote areas, and ambient-based method evaluations in various air sheds across the U.S.  In response to these CASAC AMMS suggestions, EPA is carrying out studies, in addition to the tasks outlined in the research plan, for the NOy method.  The results of these studies will likely take a year or more to become available.  As noted previously, EPA anticipates that these results will be favorable and will confirm the adequacy of the NOy method as a suitable FRM for determining compliance with an AAI-based secondary standard.
V.	Statutory and Executive Order Reviews
A.	Executive Order 12866: Regulatory Planning and Review and Review and Executive Order 13563:  Improving Regulation and Regulatory Review
	 Under Executive Order 12866 (58 FR 51735, October 4, 1993), this action is a "significant regulatory action" because it was deemed to "raise novel legal or policy issues."  Accordingly, EPA submitted this action to the Office of Management and Budget (OMB) for review under Executive Orders 12866 and 13563 (76 FR 3821, January 21, 2011), and any changes made in response to OMB recommendations have been documented in the docket for this action.
B.	Paperwork Reduction Act
	This action does not impose an information collection burden under the provisions of the Paperwork Reduction Act, 44 U.S.C. 3501 et seq.  Burden is defined at 5 CFR 1320.3(b). There are no information collection requirements directly associated with the establishment of a NAAQS under section 109 of the CAA.
C.	Regulatory Flexibility Act
	For purposes of assessing the impacts of today's rule on small entities, small entity is defined as:  (1) a small business that is a small industrial entity as defined by the Small Business Administration's (SBA) regulations at 13 CFR 121.201;  (2) a small governmental jurisdiction that is a government of a city, county, town, school district or special district with a population of less than 50,000; and (3) a small organization that is any not-for-profit enterprise which is independently owned and operated and is not dominant in its field.
	After considering the economic impacts of today's proposed rule on small entities, I certify that this action will not have a significant economic impact on a substantial number of small entities.  This proposed rule will not impose any requirements on small entities.  Rather, this rule establishes national standards for allowable concentrations of oxides of nitrogen and sulfur in ambient air as required by section 109 of the CAA.  See also American Trucking Associations v. EPA. 175 F. 3d at 1044-45 (NAAQS do not have significant impacts upon small entities because NAAQS themselves impose no regulations upon small entities).  We continue to be interested in the potential impacts of the proposed rule on small entities and welcome comments on issues related to such impacts
D.	Unfunded Mandates Reform Act
 	Title II of the Unfunded Mandates Reform Act of 1995 (UMRA), Public Law 104-4, establishes requirements for Federal agencies to assess the effects of their regulatory actions on State, local, and Tribal governments and the private sector. Under section 202 of the UMRA, EPA generally must prepare a written statement, including a cost-benefit analysis, for proposed and final rules with "Federal mandates" that may result in expenditures to State, local, and Tribal governments, in the aggregate, or to the private sector, of $100 million or more in any 1 year.  Before promulgating an EPA rule for which a written statement is needed, section 205 of the UMRA generally requires EPA to identify and consider a reasonable number of regulatory alternatives and to adopt the least costly, most cost-effective or least burdensome alternative that achieves the objectives of the rule. The provisions of section 205 do not apply when they are inconsistent with applicable law.  Moreover, section 205 allows EPA to adopt an alternative other than the least costly, most cost-effective or least burdensome alternative if the Administrator publishes with the final rule an explanation why that alternative was not adopted. Before EPA establishes any regulatory requirements that may significantly or uniquely affect small governments, including Tribal governments, it must have developed under section 203 of the UMRA a small government agency plan. The plan must provide for notifying potentially affected small governments, enabling officials of affected small governments to have meaningful and timely input in the development of EPA regulatory proposals with significant Federal intergovernmental mandates, and informing, educating, and advising small governments on compliance with the regulatory requirements.
	This action contains no Federal mandates under the provisions of Title II of the Unfundated Mandates Reform Act of 1995 (UMRA), 2 U.S.C. 1531-1538 for State, local, or tribal governments or the private sector.  Therefore, this action is not subject to the requirements of sections 202 or 205.  Furthermore, as indicated previously, in setting a NAAQS EPA cannot consider the economic or technological feasibility of attaining ambient air quality standards; although such factors may be considered to a degree in the development of State plans to implement the standards.  See also American Trucking Associations v. EPA, 175 F. 3d at 1043 (noting that because EPA is precluded from considering costs of implementation in establishing NAAQS, preparation of a Regulatory Impact Analysis pursuant to the Unfunded Mandates Reform Act would not furnish any information which the court could consider in reviewing the NAAQS).  Accordingly, EPA has determined that the provisions of sections 202, 203, and 205 of the UMRA do not apply to this proposed decision.  The EPA acknowledges, however, that any corresponding revisions to associated SIP requirements and air quality surveillance requirements, 40 CFR part 51 and 40 CFR part 58, respectively, might result in such effects.  Accordingly, EPA will address, as appropriate, unfunded mandates if and when it proposes any revisions to 40 CFR parts 51 or 58.
E.	Executive Order 13132: Federalism
	This proposed rule does not have federalism implications.  It will not have substantial direct effects on the States, on the relationship between the national government and the States, or on the distribution of power and responsibilities among the various levels of government, as specified in Executive Order 13132 because it does not contain legally binding requirements. Thus, the requirements of Executive Order 13132 do not apply to this rule.
	EPA believes, however, that this proposed rule may be of significant interest to State governments.  However, as also noted in section E (above) on UMRA, EPA recognizes that States will have a substantial interest in this rule and any corresponding revisions to associated SIP requirements and air quality surveillance requirements, 40 CFR part 51 and 40 CFR part 58, respectively.  Therefore, in the spirit of Executive Order 13132 and consistent with EPA policy to promote communications between EPA and State and local governments, EPA specifically solicits comment on this proposed rule from State and local officials.
F.	Executive Order 13175: Consultation and Coordination with Indian Tribal Governments
	Executive Order 13175, entitled "Consultation and Coordination with Indian Tribal Governments" (65 FR 67249, November 9, 2000), requires EPA to develop an accountable process to ensure "meaningful and timely input by tribal officials in the development of regulatory policies that have tribal implications."  This rule concerns the establishment of national standards to address the public welfare effects of oxides of nitrogen and sulfur.
	This action does not have Tribal implications, as specified in Executive Order 13175 (65 FR 67249, November 9, 2000).  It does not have a substantial direct effect on one or more Indian tribes, since tribes are not obligated to adopt or implement any NAAQS.  Thus, Executive Order 13175 does not apply to this rule.
G.	Executive Order 13045: Protection of Children from Environmental Health & Safety Risks
      The EPA interprets EO 13045 (62 FR 19885, April 23, 1997) as applying only to those regulatory actions that concern health or safety risks, such that the analysis required under section 5-501 of the EO has the potential to influence the regulation.  This action is not subject to EO 13045 because it addresses the effects on public welfare of oxides of nitrogen and sulfur and does not establish an environmental standard intended to mitigate health or safety risks.
H.	Executive Order 13211: Actions that Significantly Affect Energy Supply, Distribution or Use
	This action is not a "significant energy action" as defined in Executive Order 13211 (66 FR 28355, May 22, 2001), because it is not likely to have a significant adverse effect on the supply, distribution, or use of energy.  This action concerns the establishment of national standards to address the public welfare effects of oxides of nitrogen and sulfur.   This action does not prescribe specific pollution control strategies by which these ambient standards will be met.  Such strategies will be developed by States on a case-by-case basis, and EPA cannot predict whether the control options selected by States will include regulations on energy suppliers, distributors, or users.
I.	National Technology Transfer and Advancement Act
	Section 12(d) of the National Technology Transfer and Advancement Act of 1995 (NTTAA), Public Law No. 104-113, 12(d) (15 U.S.C. 272 note) directs EPA to use voluntary consensus standards in its regulatory activities unless to do so would be inconsistent with applicable law or otherwise impractical.  Voluntary consensus standards are technical standards (e.g., materials specifications, test methods, sampling procedures, and business practices) that are developed or adopted by voluntary consensus standards bodies.  The NTTAA directs EPA to provide Congress, through OMB, explanations when the Agency decides not to use available and applicable voluntary consensus standards.
	This proposed rulemaking does not involve technical standards. Therefore, EPA is not considering the use of any voluntary consensus standards.
J.	Executive Order 12898: Federal Actions to Address Environmental Justice in Minority Populations and Low-Income Populations
	Executive Order 12898 (59 FR 7629 (Feb. 16, 1994)) establishes federal executive policy on environmental justice.  Its main provision directs federal agencies, to the greatest extent practicable and permitted by law, to make environmental justice part of their mission by identifying and addressing, as appropriate, disproportionately high and adverse human health or environmental effects of their programs, policies, and activities on minority populations and low-income populations in the United States.
	EPA has determined that this proposed rule will not have disproportionately high and adverse human health or environmental effects on minority or low-income populations because it retains the level of environmental protection for all affected populations without having any disproportionately high and adverse human health or environmental effects on any population, including any minority or low-income population.

References
Baker JP; Bernard DP; Christensen SW; Sale MJ. 1990. Biological effects of changes in surface water acid-base chemistry. (State of science / technology report #13).Washington DC: National Acid Precipitation Assessment Program (NAPAP).
Bulger AJ; Cosby BJ; Webb JR. 2000. Current, reconstructed past, and projected future status of brook trout (Salvelinus fontinalis) streams in Virginia. Can J Fish Aquat Sci, 57, 1515-1523.
Banzhaf, S., D. Burtraw, D. Evans, and A. Krupnick. 2006. "Valuation of Natural Resource Improvements in the Adirondacks." Land Economics 82:445-464.
Lavery, T.F. C.M. Rogers, R. Baumgardner, and K.P. Mishoe. 2009. Intercomparison of Clean Air Status and Trends Network Nitrate and Nitric Acid Measurements with Data from Other Monitoring Programs. J. Air & Waste Manage. Assoc., 59, 214-226.
Lien L; Raddum GG; Fjellheim A. 1992. Critical loads for surface waters: invertebrates and fish. (Acid rain research report no 21). Oslo, Norway: Norwegian Institute for Water Research.
Luke, W.T., P.K. Barry, L. Lefer, J. Flynn, B. Rappenglück, M. Leuchner, J.E. Dibb, L.D. Ziemba, C.H. Anderson, and M. Buhr. 2010. Measurements of primary trace gases and NOY composition in Houston, Texas.  Atmospheric Environment, 44, 4068-4080.
MacAvoy SW; Bulger AJ. 1995. Survival of brook trout (Salvelinus fontinalis) embryos and fry in streams of different acid sensitivity in Shenandoah National Park, USA. Water Air Soil Pollut, 85, 445-450.
McNulty SG; Cohen EC; Myers JAM; Sullivan TJ; Li H. 2007. Estimates of critical acid loads and exceedances for forest soils across the conterminous United States. Environ Pollut, 149, 281-292.
NAPAP. 1990. Acid Deposition: State of Science and Technology. National Acid Precipitation Assessment Program. Office of the Director, Washington, DC.
NAPAP. (2005). National acid precipitation assessment program report to Congress: An integrated assessment.  http://www.esrl.noaa.gov/csd/aqrs/reports/napapreport05.pdf. Silver Spring, MD: National Acid Precipitation Assessment Program (NAPAP); Committee on Environment and Natural Resources (CENR) of the National Science and Technology Council (NSTC).
NRC (National Research Council). 2004. Air quality management in the United States. Washington, DC: National Research Council (NRC); The National Academies Press.
Russell, A and J. M. Samet, 2010a. Review of the Policy Assessment for the Review of the Secondary National Ambient Air Quality Standard for NOx and SOx: First Draft. EPA-CASAC-10-014.
Russell, A and J. M. Samet, 2010b. Review of the Policy Assessment for the Review of the Secondary National Ambient Air Quality Standard for NOx and SOx: Second Draft. EPA-CASAC-11-003.
Russell, A and J. M. Samet, 2011. Review of the Policy Assessment for the Review of the Secondary National Ambient Air Quality Standard for NOx and SOx: FINAL. EPA-CASAC-11-005.
Russell and Samet, 2011b Review of EPA Draft Documents on Monitoring and Methods for Oxides of Nitrogen (NOx) and Sulfur (SOx) http://yosemite.epa.gov/sab/sabpeople.nsf/WebCommittees/CASAC
Sickles II, J.E., L. L. Hodson, and L. M. Vorburger. 1999. Evaluation of the filter pack for long-duration sampling of ambient air. Atmospheric Environment, 33, 2187-2202.
Sickles II, J.E. and D.S. Shadwick. 2008. Comparison of particulate sulfate and nitrate at collocated CASTNET and IMPROVE sites in the eastern US.  Atmospheric Environment, 42, 2062-2073.
Smyth SC, W. Jiang, and H. Roth. 2008. A comparative performance evaluation of the AURAMS and CMAQ air quality modeling systems. Atmos Envir 43:1059-1070.
Stoddard J; Kahl JS; Deviney FA; DeWalle DR; Driscoll CT; Herlihy AT; Kellogg JH; Murdoch PS; Webb JR; Webster KE. (2003). Response of surface water chemistry to the Clean Air Act Amendments of 1990 (No. EPA 620/R-03/001). Research Triangle Park, NC; National Health and Environmental Effects Research Laboratory; Office of Research and Development; U.S. Environmental Protection Agency.
Sullivan TJ; Driscoll CT; Cosby BJ; Fernandez IJ; Herlihy AT; Zhai J; Stemberger R; Snyder KU; Sutherland JW; Nierzwicki-Bauer SA; Boylen CW; McDonnell TC; Nowicki NA. 2006. Assessment of the extent to which intensively studied lakes are representative of the Adirondack Mountain region. (Final Report no 06-17).Corvallis, OR; prepared by Environmental Chemistry, Inc. for: Albany, NY; Environmental Monitoring Evaluation and Protection Program of the New York State Energy Research and Development Authority (NYSERDA).
US EPA, 1973. "Effects of Sulfur Oxide in the Atmosphere on Vegetation". Revised Chapter 5 of Air Quality Criteria For Sulfur Oxides. U.S. Environmental Protection Agency. Research Triangle Park, N.C. EPA-R3-73-030.
US EPA. 1982. Review of the National Ambient Air Quality Standards for Sulfur Oxides: Assessment of Scientific and Technical Information. OAQPS Staff Paper. EPA-450/5-82-007. U.S. Environmental Protection Agency, Office of Air Quality Planning and Standards, Research Triangle Park, NC.
US EPA, 1984a. The Acidic Deposition Phenomenon and Its Effects: Critical Assessment Review Papers. Volume I Atmospheric Sciences. EPA-600/8-83-016AF. Office of Research and Development, Washington, DC
US EPA, 1984b. The Acidic Deposition Phenomenon and Its Effects: Critical Assessment Review Papers. Volume II Effects Sciences. EPA-600/8-83-016BF. Office of Research and Development, Washington, DC
US EPA, 1985. The Acidic Deposition Phenomenon and Its Effects: Critical Assessment Document. EPA-600/8-85/001. Office of Research and Development, Washington, DC
US EPA. 1995a. Review of the National Ambient Air Quality Standards for Nitrogen Dioxide: Assessment of Scientific and Technical Information. OAQPS Staff Paper. EPA-452/R-95-005. U.S. Environmental Protection Agency, Office of Air Quality Planning and Standards, Research Triangle Park, NC. September.
US EPA. 1995b. Acid Deposition Standard Feasibility Study Report to Congress. U.S. Environmental Protection Agency, Washington, DC. EPA-430/R-95-001a.
US EPA 2007. Integrated Review Plan for the Secondary National Ambient Air Quality Standards for Nitrogen Dioxide and Sulfur Dioxide. U.S. Environmental Protection Agency, Research Triangle Park, NC, EPA-452/R-08-006.
US EPA 2008. Integrated Science Assessment (ISA) for Oxides of Nitrogen and Sulfur Ecological Criteria (Final Report). U.S. Environmental Protection Agency, Washington, D.C., EPA/600/R-08/082F, 2008.
US EPA 2009. Risk and Exposure Assessment for Review of the Secondary National Ambient Air Quality Standards for Oxides of Nitrogen and Oxides of Sulfur-Main Content - Final Report. U.S. Environmental Protection Agency, Washington, D.C., EPA-452/R-09-008a
US EPA, 2010a. CASTNET Quality Assurance Project Plan, Revision 7.0, October 2010, http://java.epa.gov/castnet/
US EPA, 2010b.  CASTNET Annual Reports, 2004 - 2009, http://java.epa.gov/castnet/
US EPA 2011. Policy Assessment for the Review of the Secondary National Ambient Air Quality Standards for Oxides of Nitrogen and Oxides of Sulfur. U.S. Environmental Protection Agency, Washington, D.C., EPA-452/R-11-005a.
US EPA, 2011b.  Federal Reference Methods for NOy and p-SO4 for the New Combined NOx and SOx Secondary NAAQS Research Plan, EPA/600/1-11/002 January 20, 2011.
Wolff, G. T. 1993. CASAC closure letter for the 1993 Criteria Document for Oxides of Nitrogen addressed to U.S. EPA Administrator Carol M. Browner dated September 30, 1993.
Wolff, G. T. 1995. CASAC closure letter for the 1995 OAQPS Staff Paper addressed to U.S. EPA Administrator Carol M. Browner dated August 22, 1995.


[Federal Register Volume 85, Number 141 (Wednesday, July 22, 2020)]
[Notices]
[Pages 44305-44307]
[FR Doc No: 2020-15907]

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

DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2020-D-1079]

Cannabis and Cannabis-Derived Compounds: Quality Considerations
for Clinical Research; Draft Guidance for Industry; Availability

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice of availability.

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

SUMMARY: The Food and Drug Administration (FDA or Agency) is announcing
the availability of a draft guidance for industry entitled ``Cannabis
and Cannabis-Derived Compounds: Quality Considerations for Clinical
Research.'' This draft guidance outlines FDA's current thinking on
several topics relevant to the development of cannabis and cannabis-
derived products: The source of cannabis and cannabis-derived compounds
for clinical research; general quality considerations for developing
drugs that contain cannabis and cannabis-derived compounds; and
calculation of percent delta-9 tetrahydrocannabinol (THC) in botanical
raw materials, extracts, and finished products. This draft guidance has
been developed to help support clinical research into development of
cannabis and cannabis-derived products.

DATES: Submit either electronic or written comments on the draft
guidance by September 21, 2020 to ensure that the Agency considers your
comment on this draft guidance before it begins work on the final
version of the guidance.

ADDRESSES: You may submit comments on any guidance at any time 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): Dockets Management Staff (HFA-305), Food and Drug
Administration, 5630 Fishers Lane, Rm. 1061, Rockville, MD 20852.
     For written/paper comments submitted to the Dockets
Management Staff, 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 No.
FDA-2020-D-1079 for ``Cannabis and Cannabis-Derived Compounds: Quality
Considerations for Clinical Research.'' 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 Dockets Management Staff between 9 a.m. and 4 p.m., Monday through
Friday,<PHONE_NUMBER>.
     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 Dockets Management Staff. 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: https://www.govinfo.gov/content/pkg/FR-2015-09-18/pdf/2015-23389.pdf.
    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 Dockets Management Staff, 5630 Fishers Lane,
Rm. 1061, Rockville, MD 20852,<PHONE_NUMBER>.
    You may submit comments on any guidance at any time (see 21 CFR
10.115(g)(5)).
    Submit written requests for single copies of the draft guidance to
the Division of Drug Information, Center for Drug Evaluation and
Research, Food and Drug Administration, 10001 New Hampshire Ave.,
Hillandale Building, 4th Floor, Silver Spring, MD 20993-0002. Send one
self-addressed adhesive label to assist that office in processing your
requests. See the SUPPLEMENTARY INFORMATION section for electronic
access to the draft guidance document.

FOR FURTHER INFORMATION CONTACT: Amy Muhlberg, Center for Drug
Evaluation and Research, Food and Drug Administration, Bldg. 51, Rm.
3117, 10903 New Hampshire Ave., Silver Spring, MD 20993-0002, 240-402-
6901 or Cassandra Taylor, Center for Drug Evaluation and Research, Food
and Drug Administration, Bldg. 51, Rm. 4150, 10903 New Hampshire Ave.,
Silver Spring, MD 20993-0002,<PHONE_NUMBER>.

SUPPLEMENTARY INFORMATION:

I. Background

    FDA is announcing the availability of a draft guidance for industry
entitled ``Cannabis and Cannabis-Derived Compounds: Quality
Considerations for Clinical Research.''
    This draft guidance outlines FDA's current thinking on several
topics relevant to the development of drugs containing cannabis and
cannabis-derived compounds: (1) The source of cannabis and cannabis-
derived compounds for clinical research; (2) general quality
considerations for developing drugs that contain cannabis and cannabis-
derived compounds; and (3) calculation of percent delta-9 THC in
botanical raw materials, extracts, and finished products. This draft
guidance has been developed to help support clinical research into
development of drugs containing cannabis and cannabis-derived
compounds.
    Cannabis and cannabis-derived compounds have been the subject of
interest from consumers, industry, researchers, the public, and
regulators. The Agriculture Improvement Act of 2018, Public Law 115-334
(the 2018 Farm Bill), changed certain federal authorities relating to
the production and marketing of cannabis and cannabis-derived
compounds. Among other things, the 2018 Farm Bill removed hemp from
Schedule I controls in the Controlled Substances Act (CSA). The 2018
Farm Bill also explicitly preserved FDA's authority to regulate
products containing cannabis or cannabis-derived compounds under the
Federal Food, Drug, and Cosmetic Act (FD&C Act) and section 351 of the
Public Health Service Act (PHS Act) (42 U.S.C. 262). In doing so,
Congress recognized FDA's important public health role with respect to
all the products it regulates. Accordingly, consistent with the 2018
Farm Bill, drugs that contain cannabis and cannabis-derived compounds
are subject to the same authorities and requirements as FDA-regulated
products containing any other substance, regardless of whether the
products fall within the definition of hemp under the 2018 Farm Bill.
    The Drug Enforcement Administration (DEA) is the lead Federal
agency for regulating controlled substances. FDA does not enforce the
CSA or other laws within DEA's jurisdiction. Activities related to
growing and manufacturing cannabis for use as an investigational drug
for research must comply with CSA and DEA requirements if the cannabis
exceeds the threshold of 0.3 percent delta-9 THC by dry weight.
Sponsors and investigators are encouraged to contact DEA with questions
regarding Schedule I cannabis or the CSA.
    FDA held a public hearing \1\ on May 31, 2019, to obtain scientific
data and information about the safety, manufacturing, product quality,
marketing, labeling, and sale of products containing cannabis or
cannabis-derived compounds. The hearing was attended by more than 600
participants in person and over 2,300 joining remotely. Presentations
by over 100 speakers represented a broad and diverse array of
stakeholders. Nearly 4,500 comments were submitted to the docket
associated with the hearing, and the docket's closing date was extended
to

accommodate greater participation. FDA developed this draft guidance in
part to respond to issues and questions raised in the discussion at
that hearing and in many of the public comments received.
---------------------------------------------------------------------------

    \1\ ``Scientific Data and Information About Products Containing
Cannabis or Cannabis-Derived Compounds''; https://www.fda.gov/news-events/fda-meetings-conferences-and-workshops/scientific-data-and-information-about-products-containing-cannabis-or-cannabis-derived-compounds.
---------------------------------------------------------------------------

    Although the hearing was not exclusively about cannabidiol (CBD),
this compound was a key discussion topic. FDA and many stakeholders
have concerns about marketed products that contain CBD, including
concerns about potential contamination and inaccurate or misleading
labeling. FDA would like to reiterate that EPIDIOLEX[supreg]
(cannabidiol) is the sole FDA-approved \2\ product derived from an
extract of the cannabis plant.
---------------------------------------------------------------------------

    \2\ See Epidiolex drug approval package and labeling, available
at https://www.accessdata.fda.gov/drugsatfda_docs/nda/2018/210365Orig1s000TOC.cfm.
---------------------------------------------------------------------------

    Many sponsors initiating clinical research for drugs containing
cannabis and cannabis-derived compounds may be unclear regarding, or
unfamiliar with, applicable drug quality expectations. In general,
drugs containing cannabis and cannabis-derived compounds are subject to
the same authorities and requirements as drugs containing any other
substance. Drugs intended for human use are evaluated by FDA's Center
for Drug Evaluation and Research (CDER \3\) to ensure that drugs
marketed in the United States are safe and effective for their intended
uses and will be manufactured in a manner that ensures quality. CDER
has published extensive regulations and guidance documents regarding
the drug development and review process. In addition, FDA's website
contains useful explanations regarding drug research and development.
Finally, CDER's Small Business and Industry Assistance helps small
pharmaceutical businesses and industry navigate the wealth of
information that FDA offers, and assists in understanding the
regulation of human drug products.
---------------------------------------------------------------------------

    \3\ FDA's Center for Biologics Evaluation and Research (CBER)
also has regulatory responsibilities with respect to the review of
human drugs.
---------------------------------------------------------------------------

    FDA's support of drug development extends to drugs containing
cannabidiol and other compounds found in cannabis. One important
element is encouraging drug developers to meet with FDA early in their
development programs--ideally, before submitting an investigational new
drug (IND) application. The pre-IND meeting is an opportunity to obtain
FDA input on research plans and required content for an IND submission.
The pre-IND meeting can be valuable in planning a drug development
program, especially if sponsors' questions are not fully answered by
guidances and other information provided by FDA. Early interactions
with FDA staff through a pre-IND meeting can answer sponsors' questions
related to a specific drug development program and provide information
that will assist them in preparing complete IND applications. Efficient
use of FDA resources can lead to more efficient drug development.
    The FDA web page ``FDA and Cannabis: Research and Drug Approval
Process'' (available at https://www.fda.gov/news-events/public-health-focus/fda-and-cannabis-research-and-drug-approval-process) provides the
basic roadmap for conducting clinical research at FDA using cannabis
and cannabis-derived compounds. The resources on this page may be
helpful to those interested in better understanding FDA processes for
conducting clinical trials using cannabis and cannabis-derived
compounds.
    Calculating the amount of a substance in a botanical raw material
by dry weight is a standard procedure. However, the calculation of dry
weight for an extract or solid oral dosage form is less familiar to
many stakeholders than the standard calculation for botanical raw
materials. Therefore, the draft guidance recommends calculating delta-9
THC by dry weight in intermediates and drug products by removing the
water content, including water contained in excipients. We invite
comment from the public on this recommended approach. In addition, FDA
invites public comment on the appropriate manufacturing controls over
materials that cross under the 0.3 percent delta-9 THC by dry weight
threshold during the production of a drug that contains cannabis or
cannabis derived compounds.
    This draft guidance is being issued consistent with FDA's good
guidance practices regulation (21 CFR 10.115). The draft guidance, when
finalized, will represent the current thinking of FDA on ``Cannabis and
Cannabis-Derived Compounds: Quality Considerations for Clinical
Research.'' It does not establish any rights for any person and is not
binding on FDA or the public. You can use an alternative approach if it
satisfies the requirements of the applicable statutes and regulations.

II. Paperwork Reduction Act of 1995

    FDA tentatively concludes that this draft guidance contains no
collection of information. Therefore, clearance by the Office of
Management and Budget (OMB) under the Paperwork Reduction Act of 1995
(PRA) (44 U.S.C. 3501-3521) is not required.
    However, this draft guidance refers to previously approved FDA
collections of information. These collections of information are
subject to review by OMB under the PRA. The collections of information
in 21 CFR parts 312 and 314 for submission and approval of applications
for investigational drugs and new drugs have been approved under OMB
control numbers 0910-0014 and 0910-0001 respectively; and current Good
Manufacturing Practices for Finished Pharmaceuticals as outlined in 21
CFR parts 210 and 211 have been approved under OMB control number 0910-
0139.

III. Electronic Access

    Persons with access to the internet may obtain the draft guidance
at either https://www.fda.gov/drugs/guidance-compliance-regulatory-information/guidances-drugs or https://www.regulations.gov.

    Dated: July 16, 2020.
Lowell J. Schiller,
Principal Associate Commissioner for Policy.
[FR Doc. 2020-15907 Filed 7-21-20; 8:45 am]
BILLING CODE 4164-01-P


MEMORANDUM

TO:		Charlene Spells, EPA/OAQPS/SPPD/FIG

FROM:	David Hendricks, EC/R, Inc.

DATE:	December 2, 2015

SUBJECT:	Summary of the December 1, 2015, Meeting with Hess Corporation and the U.S. Environmental Protection Agency
--------------------------------------------------------------------------------

I.	INTRODUCTION

Hess Corporation (Hess) requested this meeting with EPA to present an overview of their comments on the September 18, 2015 proposed Oil and Natural Gas Sector NSPS (80 FR 56593).

II.	ATTENDEES

The following is a list of participants in the meeting.

U.S. Environmental Protection Agency
Amy Hambrick
Jodi Howard
Alex Macpherson
Bruce Moore
Lisa Thompson
Matthew Witosky

Hess Corporation
Blane Helton
Alan Lindsey
Joel Noyes
Lesley Schaaff
Vicky Sund
Tony Webster

EC/R Incorporated
David Hendricks

III.	SUMMARY OF DISCUSSION

Bruce Moore opened the meeting and explained to the attendees that since the EPA is in the post-proposal phase of the NSPS and CTG, EPA personnel would listen to their comments but cannot respond to any of the issues raised. However, the EPA welcomed the comments. The attendees offered the following comments.

Background on Hess
 Hess is a global company that focuses on exploration and production. Their operations are generally evenly split between domestic and international as well as onshore and offshore. About 80 percent of their production is oil.
 The company's largest assets are in the Bakken, where they operate about 1,200 wells. They have been operating there since 1951. Also operate in Texas.

Infrastructure Challenges in North Dakota
 The infrastructure of most production companies is lagging behind the production expansion in the Bakken. Hess has recently spent over $1.5 billion dollars to upgrade infrastructure.
 Highly reliant on third party mid-stream companies to provide infrastructure.
 Capacities issues related to infrastructure limit gas recovery.
 Long lead times to permit pipelines and obtain the necessary right of ways. One federal permit took several years to obtain.
 North Dakota has instituted guidelines to help manage infrastructure expansion with the intent of reducing flaring.
 Industry developed best practices and recommendations to the state.
 State issued guidance policy for new wells. Before wells can be drilled, must submit a gas capture plan, including input from the mid-stream company receiving the gas showing that they have the necessary capacity. Operators are required to capture 77 percent of gas from wells. This will go up to 80 percent in April 2016, 85 percent in November 2016, 88 percent in November 2018, 91 percent in November 2020, and eventually to 95 percent. If targets are not met, then the state can implement daily fines or even shut in the well.

NSPS Proposal

 Would like to reconcile differences between current North Dakota rules and the proposed NSPS.
 Green Completions
 During Hess's completion process, the flow is typically directed to a separator immediately upon beginning flowback. There is no period of time during completion that they cannot combust the gas from the well.
 North Dakota does not allow any direct venting of gas during the completion process.
 Concerned that the proposed rule appears to exclude the option of flaring during initial flowback.
 Concerned that "technically infeasible" as it refers to directing recovered gas to a pipeline is not clearly delineated.
 Fugitive Emissions Monitoring Program
 Will provide comments on the safety and logistical challenges of conducting surveys in oilfields.
 Concerned that a component count would be necessary in order to calculate the percent leaking components.


[Federal Register Volume 78, Number 120 (Friday, June 21, 2013)]
[Rules and Regulations]
[Pages 37452-37454]
[FR Doc No: 2013-14740]

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

DEPARTMENT OF TRANSPORTATION

Federal Aviation Administration

14 CFR Part 97

[Docket No. 30906; Amdt. No. 3541]

Standard Instrument Approach Procedures, and Takeoff Minimums and
Obstacle Departure Procedures; Miscellaneous Amendments

AGENCY: Federal Aviation Administration (FAA), DOT.

ACTION: Final rule.

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

SUMMARY: This rule establishes, amends, suspends, or revokes Standard
Instrument Approach Procedures (SIAPs) and associated Takeoff Minimums
and Obstacle Departure Procedures for operations at certain airports.
These regulatory actions are needed because of the adoption of new or
revised criteria, or because of changes occurring in the National
Airspace System, such as the commissioning of new navigational
facilities, adding new obstacles, or changing air traffic requirements.
These changes are designed to provide safe and efficient use of the
navigable airspace and to promote safe flight operations under
instrument flight rules at the affected airports.

DATES: This rule is effective June 21, 2013. The compliance date for
each SIAP, associated Takeoff Minimums, and ODP is specified in the
amendatory provisions.
    The incorporation by reference of certain publications listed in
the regulations is approved by the Director of the Federal Register as
of June 21, 2013.

ADDRESSES: Availability of matter incorporated by reference in the
amendment is as follows:
    For Examination--
    1. FAA Rules Docket, FAA Headquarters Building, 800 Independence
Avenue SW., Washington, DC 20591;
    2. The FAA Regional Office of the region in which the affected
airport is located;
    3. The National Flight Procedures Office, 6500 South MacArthur
Blvd., Oklahoma City, OK 73169 or,
    4. The National Archives and Records Administration (NARA). For
information on the availability of this material at NARA, call 202-741-
6030, or go to: http://www.archives.gov/federal_register/code_of_federal_regulations/ibr_locations.html.
    Availability_All SIAPs are available online free of charge. Visit
nfdc.faa.gov to register. Additionally, individual SIAP and Takeoff
Minimums and ODP copies may be obtained from:
    1. FAA Public Inquiry Center (APA-200), FAA Headquarters Building,
800 Independence Avenue SW., Washington, DC 20591; or
    2. The FAA Regional Office of the region in which the affected
airport is located.

FOR FURTHER INFORMATION CONTACT: Richard A. Dunham III, Flight
Procedure Standards Branch (AFS-420) Flight Technologies and Programs
Division, Flight Standards Service, Federal Aviation Administration,
Mike Monroney Aeronautical Center, 6500 South MacArthur Blvd., Oklahoma
City, OK 73169 (Mail Address: P.O. Box 25082, Oklahoma City, OK 73125)
telephone:<PHONE_NUMBER>.

SUPPLEMENTARY INFORMATION: This rule amends Title 14, Code of Federal
Regulations, Part 97 (14 CFR part 97) by amending the referenced SIAPs.
The complete regulatory description of each SIAP is listed on the
appropriate FAA Form 8260, as modified by the National Flight Data
Center (FDC)/Permanent Notice to Airmen (P-NOTAM), and is incorporated
by reference in the amendment under 5 U.S.C. 552(a), 1 CFR part 51, and
Sec.  97.20 of Title 14 of the Code of Federal Regulations.
    The large number of SIAPs, their complex nature, and the need for a
special format make their verbatim publication in the Federal Register
expensive and impractical. Further, airmen do not use the regulatory
text of the SIAPs, but refer to their graphic depiction on charts
printed by publishers of aeronautical materials. Thus, the advantages
of incorporation by reference are realized and publication of the
complete description of each SIAP contained in FAA form documents is
unnecessary. This amendment provides the affected CFR sections and
specifies the types of SIAP and the corresponding effective dates. This
amendment also identifies the airport and its location, the procedure
and the amendment number.

The Rule

    This amendment to 14 CFR part 97 is effective upon publication of
each separate SIAP as amended in the transmittal. For safety and
timeliness of change considerations, this amendment incorporates only
specific changes contained for each SIAP as modified by FDC/P-NOTAMs.
    The SIAPs, as modified by FDC P-NOTAM, and contained in this
amendment are based on the criteria contained in the U.S. Standard for
Terminal Instrument Procedures (TERPS). In developing these changes to
SIAPs, the TERPS criteria were applied only to specific conditions
existing at the affected airports. All SIAP amendments in this rule
have been previously issued by the FAA in a FDC NOTAM as an emergency
action of immediate flight safety relating directly to published
aeronautical charts. The circumstances which created the need for all
these SIAP amendments requires making them effective in less than 30
days.
    Because of the close and immediate relationship between these SIAPs
and safety in air commerce, I find that notice and public procedure
before adopting these SIAPs are impracticable and contrary to the
public interest and, where applicable, that good cause exists for
making these SIAPs effective in less than 30 days.

Conclusion

    The FAA has determined that this regulation only involves an
established body of technical regulations for which frequent and
routine amendments are necessary to keep them operationally current.
It, therefore--(1) Is not a ``significant regulatory action'' under
Executive Order 12866; (2) is not a ``significant rule'' under DOT
regulatory Policies and Procedures (44 FR 11034; February 26, 1979);
and (3) does not warrant preparation of a regulatory evaluation as the
anticipated impact is so minimal. For the same reason, the FAA
certifies that this amendment will not have a significant economic
impact on a substantial number of small entities under the criteria of
the Regulatory Flexibility Act.

List of Subjects in 14 CFR part 97:

    Air Traffic Control, Airports, Incorporation by reference, and
Navigation (Air).

    Issued in Washington, DC on June 7, 2013.
John M. Allen,
Director, Flight Standards Service.

Adoption of the Amendment

    Accordingly, pursuant to the authority delegated to me, Title 14,
Code of Federal regulations, Part 97, 14 CFR part 97, is amended by
amending Standard Instrument Approach Procedures, effective at 0901 UTC
on the dates specified, as follows:

PART 97--STANDARD INSTRUMENT APPROACH PROCEDURES

0
1. The authority citation for part 97 continues to read as follows:

    Authority:  49 U.S.C. 106(g), 40103, 40106, 40113, 40114, 40120,
44502, 44514, 44701, 44719, 44721-44722.

0
2. Part 97 is amended to read as follows:
    By amending: Sec.  97.23 VOR, VOR/DME, VOR or TACAN, and VOR/DME or
TACAN; Sec.  97.25 LOC, LOC/DME, LDA, LDA/DME, SDF, SDF/DME; Sec.
97.27 NDB, NDB/DME; Sec.  97.29 ILS, ILS/DME, MLS, MLS/DME, MLS/RNAV;
Sec.  97.31 RADAR SIAPs; Sec.  97.33 RNAV SIAPs; and Sec.  97.35 COPTER
SIAPs, Identified as follows:

* * * Effective Upon Publication

----------------------------------------------------------------------------------------------------------------
      AIRAC Date         State          City             Airport        FDC No.      FDC Date        Subject
----------------------------------------------------------------------------------------------------------------
7/25/13..............  AL         Mobile..........  Mobile Downtown.       3/0066       6/6/13  RNAV (GPS) RWY
                                                                                14, Amdt 1A.
7/25/13..............  FL         Tampa...........  Tampa Executive.       3/0404       6/6/13  RNAV (GPS) RWY
                                                                                23, Amdt 1.
7/25/13..............  FL         Tampa...........  Tampa Executive.       3/0405       6/6/13  ILS OR LOC RWY
                                                                                23, Amdt 1.
7/25/13..............  FL         Milton..........  Peter Prince           3/0429       6/6/13  RNAV (GPS) RWY
                                                     Field.                                      36, Amdt 1.
7/25/13..............  VQ         Christiansted...  Henry E Rohlsen.       3/0430       6/6/13  VOR RWY 28, Amdt
                                                                                19A.
7/25/13..............  VQ         Christiansted...  Henry E Rohlsen.       3/0431       6/6/13  ILS OR LOC RWY
                                                                                10, Amdt 7A.
7/25/13..............  VQ         Christiansted...  Henry E Rohlsen.       3/0432       6/6/13  RNAV (GPS) RWY
                                                                                10, Amdt 1.
7/25/13..............  NJ         Atlantic City...  Atlantic City          3/0485       6/6/13  VOR/DME RWY 22,
                                                     Intl.                                       Amdt 6.
7/25/13..............  ME         Princeton.......  Princeton Muni..       3/0753       6/6/13  RNAV (GPS) RWY
                                                                                15, Orig-A.
7/25/13..............  PA         Myerstown.......  Deck............       3/0754       6/6/13  RNAV (GPS) RWY
                                                                                19, Orig-A.
7/25/13..............  CA         Ramona..........  Ramona..........       3/6077       6/6/13  Takeoff Minimums
                                                                                and (Obstacle)
                                                                                DP, Amdt 3.
7/25/13..............  IA         Monticello......  Monticello Rgnl.       3/9327       6/6/13  RNAV (GPS) RWY
                                                                                15, Amdt 1A.
7/25/13..............  IA         Monticello......  Monticello Rgnl.       3/9328       6/6/13  RNAV (GPS) RWY
                                                                                33, Amdt 1.
----------------------------------------------------------------------------------------------------------------

[FR Doc. 2013-14740 Filed 6-20-13; 8:45 am]
BILLING CODE 4910-13-P


[Federal Register Volume 78, Number 41 (Friday, March 1, 2013)]
[Notices]
[Pages 13920-13922]
[FR Doc No: 2013-04748]

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

SECURITIES AND EXCHANGE COMMISSION

[Release No. 34-68980; File No. SR-C2-2013-009]

Self-Regulatory Organizations; C2 Options Exchange, Incorporated;
Notice of Filing and Immediate Effectiveness of a Proposed Rule Change
To Amend the Fees Schedule

February 25, 2013.
    Pursuant to Section 19(b)(1) of the Securities Exchange Act of 1934
(the ``Act''),\1\ and Rule 19b-4 thereunder,\2\ notice is hereby given
that on February 12, 2013, the C2 Options Exchange, Incorporated (the
``Exchange'' or ``C2'') filed with the Securities and Exchange
Commission (the ``Commission'') the proposed rule change as described
in Items I, II, and III below, which Items have been prepared by the
Exchange. The Commission is publishing this notice to solicit comments
on the proposed rule change from interested persons.
---------------------------------------------------------------------------

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

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

    The Exchange proposes to amend its Fees Schedule. The text of the
proposed rule change is available on the Exchange's Web site (http://www.c2exchange.com/Legal/), at the Exchange's Office of the Secretary,
and

at the Commission's Public Reference Room.

II. Self-Regulatory Organization's Statement of the Purpose of, and
Statutory Basis for, the Proposed Rule Change

    In its filing with the Commission, the Exchange included statements
concerning the purpose of and basis for the proposed rule change and
discussed any comments it received on the proposed rule change. The
text of these statements may be examined at the places specified in
Item IV below. The Exchange has prepared summaries, set forth in
sections A, B, and C below, of the most significant aspects of such
statements.

A. Self-Regulatory Organization's Statement of the Purpose of, and
Statutory Basis for, the Proposed Rule Change

1. Purpose
    On February 1, 2013, the Exchange began operating under a new fees
structure for simple, non-complex orders in equity options classes.\3\
This new fees structure factors BBO Market Width at the time of
execution into determining the amount of fees and rebates, and includes
a maximum fee of $0.85 per contract and a maximum rebate of $0.75 per
contract. More specifically, fees are calculated based on the following
formula (fees are calculated on a per-contract basis): \4\
---------------------------------------------------------------------------

    \3\ See Securities Exchange Act Release No. 68792 (January 31,
2013) (SR-C2-2013-004).
    \4\ The Market Participant Rates are different rates for
different types of market participants, and are currently set as
follows: C2 Market-Maker (30%); Public Customer (Maker) (40%); and
All Other Origins (50%).
---------------------------------------------------------------------------

    Fee = (C2 BBO Market Width at time of execution) x (Market
Participant Rate) x 50.
    Rebates are calculated based upon the following formula (rebates
are calculated on a per-contract basis): \5\
---------------------------------------------------------------------------

    \5\ The Order Size Multiplier is a different multiplier based
upon the size of the order, and are currently set as follows: 1-10
contracts in an order (36%); 11-99 contracts in an order (30%); 100-
250 contracts in an order (20%); and 251+ contracts in an order
(0%).
---------------------------------------------------------------------------

    Rebate = (C2 BBO Market Width at time of execution) x (Order Size
Multiplier) x 50.
    The C2 BBO Market Width is the difference between the quoted best
offer and best bid in each class on C2 (the displayed C2 ask price
minus the displayed C2 bid price).
    However, the new fees structure does not directly contemplate a
circumstance in which an execution occurs when there is no displayed C2
ask price. Such transactions occasionally occur, when a C2 bid is
displayed (while an ask price is not) and an order is sent to the
Exchange that immediately interacts with that displayed C2 bid.
Currently, if such a circumstance occurs, it would result in a negative
BBO Market Width, which would result in a negative fee or rebate amount
(meaning that the Exchange would actually be paying a rebate where a
fee would otherwise be assessed and that the Exchange would be
assessing a fee where a rebate would otherwise be paid \6\).
---------------------------------------------------------------------------

    \6\ No circumstance has occurred yet in which the Exchange has
assessed a fee to a Public Customer Taker who would otherwise
receive a rebate if there was a displayed C2 ask price.
---------------------------------------------------------------------------

    As such, the Exchange proposes to amend the section of its Fees
Schedule that regards this new fees structure to state that if an
execution occurs when there is no Displayed C2 Ask Price, the maximum
fee and/or rebate will apply. The purpose of this proposed change is to
ensure that fees and rebates are still assessed in circumstances where
there may not be both a bid and an offer, and that the maximum fee and/
or rebates applies in such circumstances, since the lack of a positive
BBO Market Width does not imply a narrow bid-ask spread.
2. Statutory Basis
    The Exchange believes the proposed rule change is consistent with
the Act and the rules and regulations thereunder applicable to the
Exchange and, in particular, the requirements of Section 6(b) of the
Act.\7\ Specifically, the Exchange believes the proposed rule change is
consistent with Section 6(b)(4) of the Act,\8\ which requires that
Exchange rules provide for the equitable allocation of reasonable dues,
fees, and other charges among its Trading Permit Holders and other
persons using its facilities. The Exchange believes that, if an
execution occurs when there is no displayed C2 ask price, applying the
maximum fee and/or rebate is reasonable because the new fees structure
described above and in SR-C2-2013-004 is designed to encourage tighter
quoting (and thus tighter spreads), and the execution of a trade when
there is no displayed C2 ask price will not serve to narrow the spread.
The Exchange believes that this proposed change is equitable and not
unfairly discriminatory because it will apply to all market
participants who trade when there is no displayed C2 ask price, and the
maximum amounts will be the same as they were previously and apply to
the same market participants as they did previously.
---------------------------------------------------------------------------

    \7\ 15 U.S.C. 78f(b).
    \8\ 15 U.S.C. 78f(b)(4).
---------------------------------------------------------------------------

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

    C2 does not believe that the proposed rule change will impose any
burden on competition that is not necessary or appropriate in
furtherance of the purposes of the Act. C2 does not believe that the
proposed rule change will impose any burden on intramarket competition
because it will apply to all market participants who trade when there
is no displayed C2 ask price, and the maximum amounts will be the same
as they were previously and apply to the same market participants as
they did previously. C2 does not believe that the proposed rule change
will impose any burden on intermarket competition because very few
trades occur when there is no displayed ask price, and the new C2 fees
structure is very unique and different than those offered on other U.S.
options exchanges. However, to the extent that this change could
attract market participants trading on other exchanges to do so on C2,
market participants trading on other exchanges can always elect to do
so.

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

    The Exchange neither solicited nor received comments on the
proposed rule change.

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

    The foregoing rule change has become effective pursuant to Section
19(b)(3)(A) of the Act \9\ and paragraph (f) of Rule 19b-4 \10\
thereunder. At any time within 60 days of the filing of the proposed
rule change, the Commission summarily may temporarily suspend such rule
change if it appears to the Commission that such action is necessary or
appropriate in the public interest, for the protection of investors, or
otherwise in furtherance of the purposes of the Act. If the Commission
takes such action, the Commission will institute proceedings to
determine whether the proposed rule change should be approved or
disapproved.
---------------------------------------------------------------------------

    \9\ 15 U.S.C. 78s(b)(3)(A).
    \10\ 17 CFR 240.19b-4(f).
---------------------------------------------------------------------------

IV. Solicitation of Comments

    Interested persons are invited to submit written data, views, and
arguments concerning the foregoing, including whether the proposed rule
change is consistent with the Act. Comments may be submitted by any of
the following methods:

Electronic Comments

     Use the Commission's Internet comment form (http://www.sec.gov/rules/sro.shtml); or
     Send an email to<EMAIL_ADDRESS>Please
include File Number SR-C2-2013-009 on the subject line.

Paper Comments

     Send paper comments in triplicate to Elizabeth M. Murphy,
Secretary, Securities and Exchange Commission, 100 F Street NE.,
Washington, DC 20549-1090.

All submissions should refer to File Number SR-C2-2013-009. This file
number should be included on the subject line if email is used. To help
the Commission process and review your comments more efficiently,
please use only one method. The Commission will post all comments on
the Commission's Internet Web site (http://www.sec.gov/rules/sro.shtml). Copies of the submission, all subsequent amendments, all
written statements with respect to the proposed rule change that are
filed with the Commission, and all written communications relating to
the proposed rule change between the Commission and any person, other
than those that may be withheld from the public in accordance with the
provisions of 5 U.S.C. 552, will be available for Web site viewing and
printing in the Commission's Public Reference Room, 100 F Street NE.,
Washington, DC 20549, on official business days between the hours of
10:00 a.m. and 3:00 p.m. Copies of the filing also will be available
for inspection and copying at the principal office of the Exchange. All
comments received will be posted without change; the Commission does
not edit personal identifying information from submissions. You should
submit only information that you wish to make available publicly. All
submissions should refer to File Number SR-C2-2013-009 and should be
submitted on or before March 22, 2013.
---------------------------------------------------------------------------

    \11\ 17 CFR 200.30-3(a)(12).

    For the Commission, by the Division of Trading and Markets,
pursuant to delegated authority.\11\
Kevin M. O'Neill,
Deputy Secretary.
[FR Doc. 2013-04748 Filed 2-28-13; 8:45 am]
BILLING CODE 8011-01-P


[Federal Register Volume 79, Number 214 (Wednesday, November 5, 2014)]
[Notices]
[Page 65649]
[FR Doc No: 2014-26257]

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

DEPARTMENT OF ENERGY

Federal Energy Regulatory Commission

[Docket No. EL15-13-000]

Bonneville Power Administration v. PacifiCorp; Notice of
Complaint

    Take notice that on October 30, 2014, pursuant to sections 206 and
306 of the Federal Power Act, 16 U.S.C. 824e and 825e and Rule 206 of
the Federal Energy Regulatory Commission's (Commission) Rules of
Practice and Procedure, 18 CFR 385.206, Bonneville Power Administration
(Complainant), filed a formal complaint against PacifiCorp
(Respondent), alleging that the Respondent is engaging in unjust,
unreasonable, and unduly discriminatory and/or preferential behavior in
violation of Respondent's Open Access Transmission Tariff (OATT) with
regard to Complainant's right to roll over the transmission component
of grandfathered agreements providing for bundled power and
transmission in Southeast Idaho to equivalent transmission service
under the Respondent's OATT.
    Complainant certifies that copies of the complaint were served on
the contacts for the Respondent as listed on the Commission's list of
Corporate Officials.
    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. The Respondent's
answer and all interventions, or protests must be filed on or before
the comment date. The Respondent's answer, motions to intervene, and
protests must be served on the Complainants.
    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 5 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 electronic 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 email notification when a document is added to a subscribed
docket(s). For assistance with any FERC Online service, please email
<EMAIL_ADDRESS>or call<PHONE_NUMBER> (toll free). For
TTY, call<PHONE_NUMBER>.
    Comment Date: 5:00 p.m. Eastern Time on November 19, 2014.

    Dated: October 30, 2014.
Nathaniel J. Davis, Sr.,
Deputy Secretary.
[FR Doc. 2014-26257 Filed 11-4-14; 8:45 am]
BILLING CODE 6717-01-P