EE measure: at an end-use energy consumer facility, an installed piece of equipment or system; a strategy intended to affect consumer energy use behaviors; or modification of equipment, systems, or operations that reduces the amount of energy that would otherwise have been used to deliver an equivalent or improved level of end-use service.
EE program: activity, strategy, or course of action undertaken by an implementer or administrator. Each program is defined by a unique combination of the program strategy, market segment, marketing approach, and energy efficiency measure(s) included. Programs consist of a group of projects with similar characteristics and installed in similar applications.
EE project: activity or course of action involving one or multiple energy efficiency measures at a single facility or site.
Effective useful life (EUL): an estimate of the duration of savings from individual EE measures, reported in years. Values are typically specific to individual EE measures or projects but also may be specified by program. EUL is defined through various means, including median number of years that the measures/projects installed under a program are still in place and operable.
Electricity savings: change in electricity use resulting from the implementation of EE measures and practices, reported in units of megawatt-hours (MWh).
Enforcement: process of verifying that a building meets the code. This process is typically conducted by a building code official.
Free ridership: portion of a program's supported savings that would have occurred in the absence of the program.
Gross savings: change in energy consumption and/or demand that results directly from program-related actions taken by participants in an energy efficiency program, regardless of why they participated.
Independent factors: variables (e.g., weather, occupancy, production levels) that affect electricity consumption and savings, and vary independently of the variable under study.

Independent factors: the explanatory factors (e.g., weather or occupancy) that affect the variable under study (e.g., electricity consumption) and can vary independently of the variable under study.
Inspections: site visits to facilities at which an EE project or measure was implemented. Inspections document the existence, characteristics, and operation of baseline or EE project equipment and systems, and the factors that affect energy use. Inspections can or might not include review of commissioning or retro-commissioning documentation.
Interactive effects: increases or decreases in the use of electricity or fossil fuels that occur outside of the end uses targeted by a specific EE measure, project, or program. For example, reduction in lighting loads through an energy-efficient lighting retrofit can reduce buildings' air conditioning and increase heating requirements because less heat is generated by energy-efficient lighting systems compared with less efficient lighting systems.
Market effects: changes in the supply chain for energy efficient equipment or the behavior of participants and market actors resulting from market intervention(s).
Project-based measurement and verification: PB-MV is the process of using measurements to determine electricity savings associated with individual projects or measures reliably. M&V can be applied to a census or sample of projects (measures) in a program (project) to determine average savings for the program (project). With M&V, baseline electricity consumption is compared with post-project (or post-measure) electricity consumption measurements, along with analyses and documented assumptions to quantify savings. The IPMVP defines two retrofit isolation and two whole-facility M&V options used in the efficiency industry:
   Retrofit isolation  -  assessing savings from each EE measure individually (IPMVP Options A & B). Although Option A allows some stipulation of factors, Option A differs from the use of deemed saving values in that all M&V options require some project site measurements.
   Whole facility  -  analyzing savings from each EE measure in a project/facility collectively  -  (IPMVP Option C, review of energy bills or Option D, calibrated simulation).
   Some combination of the above.
See Chapter 5 for more information on the IPMVP options.
Naturally occurring market adoption (NOMAD): proportion of savings or application of measures equivalent to the code that would have taken place in the market even if the code had not been adopted.
Net savings: change in energy consumption and/or demand that is attributable to a particular energy efficiency program. This change in energy use and/or demand may include, implicitly or explicitly, consideration of factors such as free ridership, participant and non-participant spillover, and induced market effects. These factors may be considered in how a baseline is defined (e.g., common practice) and/or in adjustments to gross savings values.
Random error: error occurring by "chance" that may cause the savings estimates to be inconsistently overstated or understated. Random errors include an observed change in energy use due to unaccounted-for factors that affect energy use.
Realization rate: the ratio of electricity savings an independent third party determines divided by the savings claimed by the measure, project, or program provider(s). The ratio's deviation from 1.0 can be due to (1) adjustments for data errors, (2) differences in implemented measure counts or other claimed information because of verification activities, or (3) other performance differences revealed through the M&V activities.
Reliability: quality of a measurement process that would produce similar results on (1) repeated observations of the same condition or event, or (2) multiple observations of the same condition or event by different observers. Reliability refers to the likelihood that the observations can be replicated.
Reporting year cumulative savings: the amount of electricity savings quantified and verified as a result of EE activities in the reporting year from both (a) EE activities operating for the first time in the reporting year and (b) EE activities initiated in prior years and still in effect; reported in annual megawatt hours, MWh.
Reporting year incremental savings: the amount of electricity savings quantified and verified as a result of EE activities operating for the first time in the reporting year; reported in annual megawatt hours, MWh.
Rigor: level of effort expended to minimize uncertainty in savings estimates such as sampling error and bias. The higher the level of rigor, the more confident one is that the results of the EM&V activities are both accurate and precise. Rigor may be quantified or described with metrics for reliability and certainty, such as in terms of reported value confidence and precision.
Spillover: additional reductions in energy consumption that are due to an EE program's influences beyond those directly associated with the installed EE measures -- these include participant and nonparticipant spillover.
Systematic error: inaccuracies in the same direction, causing savings values to be consistently either overstated or understated. Systematic errors (also referred to as bias) may result from incorrect assumptions, a methodological issue, or a flawed reporting system.
Technical reference manual (TRM): resource document that includes information used in program planning and reporting of energy efficiency programs. It can include savings values for measures, engineering algorithms to calculate savings, impact factors to be applied to calculated savings (e.g., net-to-gross ratio values), source documentation, specified assumptions, and other relevant material to support the calculation of measure and program savings -- and the application of such values and algorithms in appropriate applications.
Verification: an assessment by an independent entity to ensure that the EE measures have been installed correctly and could generate the predicted savings. Verification may include assessing baseline conditions and confirming that the EE measures are operating according to their design intent. Site inspections, phone and mail surveys, and desk review of program documentation are typical verification activities.

EM&V Methods for Common EE Programs, Projects, and Measures: Best Practices and Resources
 This appendix discusses existing best practices for quantify and verify savings, with relevance for the processes of EM&V planning, implementation, and ex-post documentation. The purpose of Appendix C is to provide illustrative examples of how EE savings can be quantified and verified at the program, project, and measure level, and to offer associated information resources and lessons gained from experience over the last several decades. Much of this information can similarly be applied to EE programs, projects, and measures that are not explicitly covered.
EM&V Methods for Select EE Program Types
Table C-1, Common EM&V Methods and Activities for Typical Consumer-Funded EE Programs, identifies the actual evaluation activities that are typically undertaken when a particular EM&V method is selected and applied.  This table is offered as an information resource, as applied to most of the common EE programs in use today.  It does not cover all program types and circumstances, does not prescribe one way to conduct EM&V (i.e., there are valid and appropriate reasons why a certain situation may call for a different method or set of EM&V activities).
Table C-1. Common EM&V Methods and Activities for Typical Consumer-Funded EE Programs
                       Type of Energy Efficiency Program
                                EM&V Method
                         Typical Evaluation Activities
                        Example Guidance and References
                                     Links

Comparison
M&V
Deemed

Residential Audit Programs
                                       X
                                       X
                                       X
   oo  Residential building simulation
   oo  Savings algorithms
   oo  Billing analysis
   oo  Surveys to determine actions taken, together with deemed savings per unit or measure
Uniform Methods Project, Chapter 8: Whole-Building Retrofit with Consumption Data Analysis Evaluation Protocol
See also SEE Action's Evaluation Measurement and Verification Portal for more references on evaluation methods and Technical Resource Manuals for deemed savings estimates by state or region
http://www.energy.gov/sites/prod/files/2013/11/f5/53827-8.pdf
https://www4.eere.energy.gov/seeaction/evaluation-measurement-and-verification-resource-portal

Residential Whole House Retrofit Programs
                                       X
                                       X
                                       X
   oo  Billing/regression analysis
   oo  Limited onsite data collection
   oo  Building Simulation analysis
   oo  Surveys to determine actions taken, together with deemed savings
Uniform Methods Project, Chapter 8: Whole-Building Retrofit with Consumption Data Analysis Evaluation Protocol
http://www.energy.gov/sites/prod/files/2013/11/f5/53827-8.pdf

Residential Lighting Retrofit Programs

                                       X
                                       X
   oo  Onsite lighting loggers & lighting inventory
   oo  Deemed hours of use (HOU) and coincidence factor (CF)
   oo  Baseline matching of equivalent light output (lumens) for technologies not covered by federal standards
Uniform Methods Project; Chapter 21: Residential Lighting Protocol (December 2014)
http://energy.gov/sites/prod/files/2015/02/f19/UMPChapter21-residential-lighting-evaluation-protocol.pdf
Residential HVAC Retrofit Programs

                                       X
                                       X
   oo  Onsite metering to determine full load hours (EFLH), capacity and CF
   oo  Deemed EFLH and CF
   oo  Gather data on system efficiency levels and charge
Uniform Methods Project, Chapter 4: Small Commercial and Residential Unitary and Split Cooling Systems protocol (April 2014)
http://energy.gov/sites/prod/files/2013/11/f5/53827-4.pdf
Residential Water Heating Retrofit Programs

                                       X
                                       X
   oo  Onsite Data collection on water usage and temperatures
   oo  Deemed system efficiencies and water usage profiles
   oo  Deemed savings values per unit capacity
Most recent study on stimulating adoption of high efficiency water heating is useful Residential Water Heating Program Facilitating the Market Transformation to Higher Efficiency Gas‐Fired Water Heating, Prepared for the CEC by Gas Technology Institute, December 2012
http://www.energy.ca.gov/2013publications/CEC-500-2013-060/CEC-500-2013-060.pdf
Residential Refrigerator Recycling Programs

                                       X
                                       X
   oo  Gather equipment model numbers to estimate removed units' consumption and part-year usage
   oo  Regression analysis to estimate usage reduction
   oo  Deemed savings values per unit capacity
Uniform Methods Project; Chapter 7: Residential Recycling Protocol (April 2013)
http://energy.gov/sites/prod/files/2013/11/f5/53827-7.pdf
Residential Consumer Electronics Replacement Programs

                                       X
                                       X
   oo  Gather data on equipment energy hourly and energy usage, and load profiles
   oo  Deemed baseline usage and savings algorithms
   oo  Deemed savings values per unit capacity
No protocols but useful references include:
(1) Set-Top-Box Pilot and Market Assessment (Research into Action, April 2015)
(2) Literature Review of Miscellaneous Energy Loads (MELs) in Residential Building, Prepared by Energy Solutions, 2014
http://www.calmac.org/publications/SCE_STB_Report_04_30_2015_FINAL.pdf

Low income Energy Efficiency Weatherization Programs
                                       X
                                       X
                                       X
   oo  Onsite data collection to verify measure installation
   oo  Billing analysis
   oo  Building simulation models
   oo  Surveys to determine actions taken, together with deemed savings
Uniform Methods Project, Chapter 8: Whole-Building Retrofit with Consumption Data Analysis Evaluation Protocol
"Evaluation of a Low-Income Energy Efficiency Program," by Jacqueline Berger, APPRISE, Paper published in ACEEE 2014 Summer Conference Proceeding
http://www.energy.gov/sites/prod/files/2013/11/f5/53827-8.pdf
Residential Behavior Programs
                                       X

   oo  Billing Analysis using Randomized Control Trials
   oo  Website usage statistics to inform billing analysis
Uniform Methods Project; Chapter 17: Residential Behavior Protocol (January 2015)
http://eetd.lbl.gov/sites/all/files/publications/behavior-based-emv.pdf
http://energy.gov/sites/prod/files/2015/02/f19/UMPChapter17-residential-behavior.pdf
Residential New Construction Programs

                                       X
                                       X
   oo  Building Simulation Analysis
   oo  HERS ratings and onsite data collection to verify system installed
   oo  Surveys to estimate baseline & naturally occurring market adoption (NOMAD)
   oo  Surveys to determine actions taken, together with deemed savings
California Energy Efficiency Evaluation Protocols: Codes And Standards and Compliance Enhancement Evaluation Protocol, April 2006, California Public Utilities Commission
Attributing Building Energy Code Savings to Energy Efficiency Programs, IEE/IMT/NEEP Report, February 2013, Prepared by: The Cadmus Group, Inc., Energy Futures Group NMR Group, Inc. Optimal Energy
http://www.calmac.org/publications/EvaluatorsProtocols_Final_AdoptedviaRuling_06-19-2006.pdf
Non Residential Lighting Programs

                                       X
                                       X
   oo  Onsite lighting loggers & lighting inventory
   oo  Deemed HOU and CF
   oo  Baseline matching of equivalent light output (lumens) for technologies not covered by standards
   oo  Surveys to determine actions taken, together with deemed savings
Uniform Methods Project, Chapter 2 Commercial and Industrial Lighting Evaluation Protocol (April 2013)
http://energy.gov/sites/prod/files/2013/11/f5/53827-2.pdf
Non Residential Lighting Controls Programs

                                       X
                                       X
   oo  Onsite metering of lighting EFLH to estimate control savings factor (CSF)
   oo  Deemed CSF
   oo  Whole building analysis if control savings expected to exceed 10% of building usage
   oo  Surveys to determine actions taken, together with deemed savings
Uniform Methods Project, Chapter 3: Commercial and Industrial Lighting Controls Evaluation Protocol (April 2013)
http://energy.gov/sites/prod/files/2013/11/f5/53827-3.pdf
Compressed Air Programs

                                       X
                                       X
   oo  Engineering estimates (with or without simulation models) based on (a) spot measurements to determine airflow, line pressure, compressor specific power, part-load performance, and operating hours and/or (b) metering to estimate compressor power, operating load and energy consumption
   oo  In some cases onsite leakage measurement for programs that seek to seal leaks
   oo  Surveys to determine actions taken, together with deemed savings
Uniform Methods Project, Chapter 22: Compressed Air Evaluation Protocol (November 2014)
http://energy.gov/sites/prod/files/2015/01/f19/UMPChapter22-compressed-air-evaluation.pdf
Commercial New Construction Programs

                                       X
                                       X
   oo  Onsite visits to gather or confirm data on building operation and characteristics
   oo  Building simulation models
   oo  Data collection to estimate baselines and NOMAD
   oo  Surveys to determine actions taken, together with deemed savings
Uniform Methods Project, Chapter 13: Commercial New Construction Evaluation Protocol (September 2013)
http://energy.gov/sites/prod/files/2014/10/f18/Chapter%2015--Commercial%20New%20Construction%20Protocol.pdf
Large Commercial and Industrial Custom Measure Programs

                                       X

   oo  Spot or short term metering of end uses and processes affected by retrofit to gather energy use and performance data
   oo  Gather data on independent variables driving consumption, including production
   oo  Develop and validate engineering savings equations using regression analysis and above indicated data
IPMVP  -  International Performance Measurement and Verification Protocol: Concepts and Options for Determining Energy and Water Savings Volume I, EVO-10000-1.2007, Efficiency Valuation Organization.
http://www.evo-world.org/index.php?view=download&alias=1543-2012-ipmvp-volume-i-in-english-27-20&option=com_docman&Itemid=1585&lang=en
Non Residential Retrocommissioning Programs

                                       X

   oo  Gather data on independent variable driving usage pre and post installation of BAS and meter data for relevant systems within boundary for engineering or computer simulation analyses
   oo  Regression analysis to adjust savings based on changes in independent variables
Uniform Methods Project, Chapter 16: Retrocommissioning Protocol (September 2014)
http://energy.gov/sites/prod/files/2014/10/f18/Chapter%2016--Retrocommissioning%20Evaluation%20Protocol.pdf
Key for Evaluation Methods
C = Comparison of usage, billing analysis to estimate net savings
M&V = Measurement and verification of key parameters used to estimate savings
D = Deemed values for key parameters used to estimate savings

Project-Based Measurement and Verification for Common EE Technologies
 As discussed in Section 3.1, PB-MV is a set of procedures for quantifying savings from an individual EE measure or project, versus an EE program. The information provided in this section illustrates how many of the EM&V topics introduced in Section 2 above are typically applied in practice to quantify and verify savings. It describes the PB-MV approaches frequently applied to quantify savings for specific technologies at the project and measure level, but does not provide guidance on whether PB-MV or deemed savings is the preferred approach (this section assumes that the decision to used PB-MV has already been made). As discussed in Section 2.1, selecting an EM&V methods involves tradeoffs between cost, accuracy, and value of the resulting information in light of available budgets and desired levels of accuracy and reliability.
Residential Lighting
Definition
These projects involve installing efficient lighting products in residential dwelling, such as Light Emitting Diode (LED) lamps, and dimmable lights and. In all cases, the measure installed is designed to promote lamps with higher efficacy (lumens/Watt) and the same or better color resolution index. This guidance is applicable to at least the following four common program design approaches, for both new construction and retrofit applications of residential lighting measures:
Direct installation of lighting products, including Energy Service Company (ESCO) projects
Consumer incentives (e.g., rebates, coupons)
Giveaways (installed for free during audits or mailed to homeowners)
Upstream/Mid-stream/Downstream buy downs of retail lamp/fixture prices (e.g., point of sale rebates)
Key Challenges in Estimating Energy Savings
The primary measurement challenges for estimating lighting technology savings evaluation are:
1. Operating hours  -  Determining the operating hours for the lighting systems (baseline and project operating hours) where in many cases the exact location, building type, and fixture type are not known or cannot be easily found.
2. Baseline wattage  -  Determining the baseline wattage of lamps being replaced by more efficient lamps (baseline wattage) when in many cases the lumen output of the baseline bulb is not known and it is not known if the more efficient lamps provides lower, higher or equivalent lumens output. In addition, for upstream programs it is not known if the more efficient bulb simply replaced a bulb of similar efficiency or efficacy.
3. Indirect savings or additional electricity use resulting from interaction with HVAC systems  - Estimating the indirect effects of installing more efficient lamps on the energy use of existing heating, ventilation and cooling systems.
4. Free Riders and Technical Progress -  Estimating underlying market adoption rates is challenging. Particularly in lighting where product innovation is occurring a rapid pace. Consequently, programs that incent switching to current long-lived technology (e.g. a CFLs installed in 2010 persist through 2020 in a light use application) may yield short term energy savings but also reduce longer-term savings that would have occurred if the consumer had later voluntarily switched to more efficient options (e.g. shifting directly from incandescent to a higher efficiency LED in 2015).

The most common evaluation methods for dealing with each challenge are discussed below:
   A. Estimating Hours of Operation (HOU)
M&V Approach
Typical Application
Self-reports from homeowner
Sites where trained auditors/contractors have installed more efficient bulbs as part of residential audit or direct install program
Deemed hours from previous evaluations or TRM
Evaluation of savings from upstream programs where retailers or distributors have received rebates to buy down incremental cost of bulbs, exact location of bulb installation is not known and the evaluation budget is not sufficient to cover cost of metering.
Install lighting loggers for short-term (from weeks to months) measurement and to extrapolate result to annual usage
Most common application in states where lighting programs have been operated for many years, lighting represents a significant portion of portfolio savings and results can be used by multiple program administrators

   B. Estimating Baseline wattage
M&V Approach
Typical Application
In-home Inspection of a sample of baseline bulbs
Direct-install programs, Residential Audit Programs where CFL or LED's are installed for low cost or free
Use multiplier factors taken from TRM or previous evaluations to directly convert tracking data on energy efficient bulb wattage to estimated delta watts
Upstream lighting programs where location of bulb installation is not known, tracking systems are not completely developed and program is in first few years of operation
Use Energy Star Lumen Equivalence Method with adjustment for EISA standards to estimate delta watts.
Upstream lighting programs where tracking systems have matured and shelf data exists to adjust baseline usage to account for EISA standard impact and possible sell through of existing product

   C. Estimating Interactive effects from efficient lighting on HVAC system usage
M&V Approach
Typical Application
Estimate indirect savings impacts using Waste Heat factors taken from previous evaluation studies or TRMs from adjacent states or regions.
Lighting Programs or Direct Project installations where efficiency of existing HVAC systems is not known
Use simulation modeling
Lighting Programs have been in effect for many years and the evaluation budget is sufficient to gather data on the system efficiency of HVAC systems where lamps have been installed

D. Other important evaluation issues
Finally, it is important to note that as lighting efficiency programs mature and the saturation of CFLs and LED increase, there will be a higher possibility that efficient lighting products will be used to replace in situ or existing efficient lighting products previously purchased. This possibility can be assessed using survey of homeowner purchase patterns or limited on site visits to a sample of participants.
Relevant protocols or evaluation studies for more information
1. Uniform Methods Project; Chapter 21: Residential Lighting Protocol (December 2014) http://www.energy.gov/sites/prod/files/2015/02/f19/UMPChapter21-residential-lighting-evaluation-protocol.pdf
2. KEMA, Inc.; Cadmus Group, Inc. (February 8, 2010). Final Evaluation Report: Upstream Lighting Program. Prepared for California Public Utilities Commission, Energy Division. http://www.calmac.org/publications/FinalUpstreamLightingEvaluationReport_Vol2_C ALMAC.pdf.
3. Navigant Consulting; Itron; Opinion Dynamics; Michaels Energy (October 23, 2013). Residential Energy Star Lighting PY5 Evaluation Report. Presented to Commonwealth Edison Company. http://www.ilsag.info/comed_eval_reports.html.
4. Nexus Market Research, Inc.; RLW Analytics, Inc. GDS Associates (January 20, 2009). Residential Lighting Markdown Impact Evaluation. Prepared for Markdown and Buydown Program Sponsors in Connecticut, Massachusetts, Rhode Island, and Vermont. http://www.env.state.ma.us/dpu/docs/electric/09-64/12409nstrd2ae.pdf

Small Commercial and Residential Unitary and Split Cooling Systems
Definition
These projects involve installing efficient cooling systems in residential and small commercial applications. Typical projects involve packaged systems with capacities between three and 20 tons and split systems with capacities <=65,000 BTU/hour (5.4 tons). This guidance is applicable to at least the following common program design approaches, for both new construction and retrofit applications of small commercial and residential unitary and split systems measures:
Direct installation of cooling systems, including ESCO projects
Consumer incentives (e.g., rebates, coupons)
Upstream/Mid-stream/Downstream buy downs of retail cooling system prices (e.g., point of sale rebates)
Key Challenges in Estimating Energy Savings
The two most difficult or primary measurement challenges for this technology are:
      1. Determining baseline efficiency conditions and
      2. Determining Equivalent Full Load Hours (EFLH) for cooling system use.

The most common evaluation methods for dealing with each challenge are discussed below:
   A. Determining Baseline Efficiency Conditions or System Ratings
M&V Approach
Typical Application
Gather baseline efficiency ratings from HVAC system equipment nameplates from a sample of participating homeowners or survey HVAC contractors to determine the CPB
For situations where contractor or homeowner reports cooling system is being replaced early or before the end of its useful life.
Use minimum efficiency level required by building or appliance code to estimate savings
For situations where the cooling system is being installed because equipment is failing or burned out or as part of a new construction project

   B. Determining Equivalent Full Load Hours for Cooling System Use
M&V Approach
Typical Application
Simulate hours of HVAC system use using building simulation models based on prototypes of typical homes and climate conditions
Situations where size, climate conditions and layout of homes is known with reasonably accuracy based on current or previous data collection
Conduct short-term metering of system use during cooling season for a short period of time, at least one month, during typical occupancy conditions),

Situations where accurate estimates of impacts on peak use are needed and there is sufficient evaluation budget to support the metering.
Use deemed hours of cooling use from neighboring state, or regional TRMs
Situations where programs are just starting out and or it is not practical to measure or meter system hours of use

Relevant Protocols and Sources for readers interested in more detailed information
1. Uniform Methods Project, Chapter 4:Small Commercial and Residential Unitary and Split Cooling Systems protocol (April 2014)
2. ASHRAE. (2010). Performance Measurement Protocols for Commercial Buildings.
3. Consortium for Energy Efficiency (CEE). (2009). Commercial Unitary AC and HP Specifications, Unitary Air Conditioning Specification. Effective January 16, 2009. www.cee1.org/com/hecac/hecactiers.pdf. ISO-New England, Inc. (June 2010).
4. ISO New England Manual for Measurement and Verification of Demand Reduction Value from Demand Resources Manual (M-MVDR).
5. KEMA. (February 10, 2010). Evaluation Measurement and Verification of the California Public Utilities Commission HVAC High Impact Measures and Specialized Commercial Contract Group Programs 2006-2008 Program Year. www.calmac.org/publications/Vol_1_HVAC_Spec_Comm_Report_02-10-10.pdf.

Residential Whole Building Retrofits
Definition
These projects involve installing multiple EE measures, such as insulation, weather stripping, set-back thermostats, efficient lighting and/or efficient heating and cooling systems in residential dwellings. The savings from individual measures usually interact with each other, so it is not appropriate to estimate the savings from individual measures and sum them.
This guidance is applicable to common program-design approaches such as Home Performance with Energy Star (HPwES), residential audit programs, and any other program that seeks to reduce overall energy use in residential dwellings using measures that address both building shell and building system improvements.
Key Measurement Challenges
The key challenge in estimating energy savings from this program type is to isolate the electricity savings from the installation of multiple measures in the participating houses from market, weather, economic and other factors that affect household electricity consumption. Three different evaluation methods to deal with this challenge and their typical applications are described in the tables below.
M&V Approach
Typical Application
Randomized Control Trials applied to a sample of participants and non-participants in the program
Programs or projects where customers can be randomly assigned the opportunity to participate in the program and do not have to be recruited.
Quasi Experimental Design to Select Participant and Comparison Groups and control for self-selection bias using regression and pooled techniques. Two approaches include:
   1.     Two-stage regression approach using past and future participants as the comparison or control group
   2.     Pooled fixed effects regression approach if there is insufficient data on past or future participants to create the comparison group
Most common program situation where customers must be recruited to join programs and install measures, billing data is available and evaluation budget is sufficient to gather detailed data on home characteristics.
Building simulation models to estimate savings using Building Characteristic Data Gathered by Program contractors or implementers
Situations where it is difficult to access sufficient billing data and or administrator has confidence in implementer's building simulation models because it has been calibrated to billing energy usage.

Relevant Protocols for More Information
See Uniform Methods Project, Chapter 8: Whole-Building Retrofit with Consumption Data Analysis Evaluation Protocol reference. http://www.energy.gov/sites/prod/files/2013/11/f5/53827-8.pdf
Commercial Lighting
Definition
These projects involve installing efficient lighting products (ballasts, lamps, and fixtures) in nonresidential buildings such as offices, grocery stores, restaurants, warehouses, retail, and multifamily housing units. Example projects include installing T5/T8 fluorescent lighting systems for general area lighting and more focused LEDs for task lighting. There are three common program delivery approaches:
Direct installation of lighting products, including ESCO projects
Consumer incentives (e.g., rebates)
Upstream/Mid-stream/Downstream buy downs of lamp and fixture prices (e.g., distributor incentives).
Key Measurement Challenges
Key measurement challenges include: 1) Ensuring lighting logger readings are carefully reviewed and screened to ensure accurate estimates of hours of use in rooms where daylighting and occupancy fluctuations can cause flicker problems. 2) Accurately weighting these use area specific HOU results into an average hours of use for the entire building 3) Determining baseline wattage of lighting systems where the precise physical location is unknown and inventories of lighting systems that do not meet current code are still available for sale.
The most common evaluation methods for dealing with each challenge are discussed below:
   A. Determining Average HOU by Room Type and Whole Building
M&V Approach
Typical Application
Collect average hours of usage by area use type from a representative sample of buildings using self-reports from building managers and or HOU estimates from forecasting models.
Project or program evaluations of new lighting projects or measures where there is insufficient time or resources to install lighting loggers and collect usage data over a 6 to 12 week period.
Retrieve hours of lighting system or fixture usage by room type from building energy management systems or time clocks
Evaluations at sites where sophisticated energy management systems log lighting usage and schedules.
Install lighting loggers in a representative sample of area use types within a sample of participating buildings.
Evaluations where savings from lighting projects constitute the majority of portfolio savings and no recent studies of lighting HOU have been conducted in available TRMS or recent evaluations

   B. Determining Baseline Lighting System Wattage
M&V Approach
Typical Application
Collect detailed fixture wattage inventory by area usage type before the lighting retrofits are installed.
For accelerated or early retirement of existing lighting systems before the projected or anticipated end of their useful lives from building manager's perspective.
Determine the CPB conditions using most recent state or federal product standards for equivalent lumens or trade ally input if market baseline is more efficient than standards. Potentially make adjustments for non-qualifying equipment that is still available in distributor warehouses.
For new construction, normal replacement, or replace on burnout projects where the baseline replacement system is most likely to be a lighting system that just meets minimum efficiency requirements
Install lighting loggers in a representative sample of room usage types within a sample of participating buildings. Develop a lighting logger quality-control protocol to ensure HOU estimates are accurate.
Evaluations where savings from lighting projects constitute the majority of portfolio savings and no recent studies of lighting HOU have been conducted in available TRMS or recent evaluations

Relevant Protocols for readers interested in more detailed information
1. Uniform Methods Project, Chapter 2: Commercial and Industrial Lighting Evaluation Protocol (April 2013)
2. California Public Utilities Commission (CPUC). (2008). http://www.deeresources.com.
3. Federal Energy Management Program (FEMP). (2008). M&V Guidelines: Measurement and Verification for Federal Energy Projects Version 3.0. http://www1.eere.energy.gov/femp/pdfs/mv_guidelines.pdf
4. Massachusetts Program Administrators. (October 2011). Massachusetts Technical Reference Manual for Estimating Savings from Energy Efficiency Measures 2012 Program Year - Plan Version. www.masssave.com.

Commercial Chiller Systems
Definition
These projects involve installing or retrofitting electricity consuming chillers and/or associated auxiliary equipment. Chillers provide mechanical cooling for commercial, institutional, multiunit residential, and industrial facilities. Cooling may be required for facility heating, ventilation, and air conditioning (HVAC) systems or for process cooling loads (e.g., data centers, manufacturing process cooling).
Key Challenges in Quantifying Energy Savings
Key measurement challenges include: (1) Determining annual electricity consumption of the existing chiller system, (2) Determining the length of the appropriate monitoring periods for collection of system data, and (3) Normalizing savings to performance period independent variables such as weather and changes in occupancy.
Baseline Energy Consumption
Methods for determining baseline electricity consumption of Chiller Systems are outlined in the table below.
M&V Approach
Typical Application
IPMVP Option A  -  Retrofit Isolation
Key parameter measurements include cooling load, outside air temperature and part-load efficiency factors from manufacturer testing
Project level evaluation where expected variation in occupancy and chiller loads is likely to be relatively low over a typical year
IPMVP Option C  -  Whole Building Billing Analysis
Pre and post installation over at least a year period
For early replacement projects where estimated costs of metering are high and the estimated savings are large compared to normal variations in total building energy usage
IPMVP Option D  -  Calibrated Building Simulation Modeling with potential adjustments for impact of new product standards and or changes in occupancy
For replace on burnout or new construction projects where baseline condition is likely to be chiller system that meets the minimum efficiency standards

All of the methods above require the evaluator to collect data on the condition of the existing equipment (with the exception of new construction) and make an estimate of the remaining useful life of the equipment for use in developing savings estimates using the dual baseline approach. To support use of existing usage conditions for early replacement projects evaluators must present evidence that the program has likely induced an early replacement of the existing chiller equipment. Data sources for condition and remaining useful life of in-situ equipment/systems include interviews with facility managers, equipment logs, inspection of equipment, and manufacturer's data.
Determining the Length of the Monitoring Period
The frequency and length of the monitoring period (for electricity consumption, cooling loads, etc.) associated with chiller equipment depends on the type of load and frequency of equipment operation. Continuous monitoring for large systems with variable loads (such as chillers service process loads) is recommended for at least three months, while spot measurements of electricity consumption can be sufficient for systems with constant loads and known hours of operation.
Normalizing Savings to Account for Independent Variables
In many cases, it will be necessary to run regression equations to separate out the impacts of chiller measures from independent variables such as operating temperatures or process throughput. The model's predictive power should be tested using R[2] values or T statistics on the estimated coefficient for the independent variable of interest to ensure accuracy. The Commercial Chiller protocol from the Uniform Methods Project recommends a model fit thresholds of >0.75 for R2 and T statistics of greater than 2.0 to determine if savings estimates are statistically significant.
Relevant Protocols and Evaluation Sources for More Information
1. Uniform Methods Project, Chapter 14: Chiller Evaluation Protocol, Chapter reference (Prepared by Alex Tiessen, Posterity Group for the National Renewable Energy Laboratory, September 2014). Reference http://www.energy.gov/sites/prod/files/2014/10/f18/Chapter%2014--Chiller%20Evaluation%20Protocol.pdf
2. EVO. (January 2012). International Performance Measurement and Verification Protocol  - Concepts and Options for Determining Energy and Water Savings Volume 1. Efficiency Valuation Organization.
3. Fagan, F., Bradley, K., Lutz, A. (2011). Strategies for Improving the Accuracy of Industrial Program Savings Estimates and Increasing Overall Program Influence. Prepared for the International Energy Program Evaluation Conference.
4. Ridge, R., Jacobs, P., Tress, H., Hall, N., Evans, B. (2011). One Solution to Capturing the Benefits of Early Replacement: When Approximately Correct is Good Enough. Prepared for the International Energy Program Evaluation Conference.
5. US DOE FEMP. (April 2008). M&V Guidelines: Measurement and Verification for Federal Energy Projects -- Version 3.0. U.S. Department of Energy Federal Energy Management


[Federal Register Volume 76, Number 33 (Thursday, February 17, 2011)]
[Proposed Rules]
[Pages 9281-9283]
[FR Doc No: 2011-3613]

=======================================================================
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ENVIRONMENTAL PROTECTION AGENCY

40 CFR Part 52

[EPA-R01-OAR-2010-0445; A-1-FRL-9267-9]

Approval and Promulgation of Air Quality Implementation Plans;
Massachusetts; Revised Carbon Monoxide Maintenance Plan for Lowell

AGENCY: Environmental Protection Agency (EPA).

ACTION: Proposed rule.

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SUMMARY: EPA is proposing to approve a State Implementation Plan (SIP)
revision submitted by the State of Massachusetts. This SIP submittal
contains revisions to the carbon monoxide (CO) maintenance plan for
Lowell, Massachusetts. Specifically, Massachusetts has revised the
contingency plan portion of the original maintenance plan. The intended
effect of this action is to propose approval of this revision to the
Lowell CO maintenance plan. This action is being taken in accordance
with the Clean Air Act.

DATES: Written comments must be received on or before March 21, 2011.

ADDRESSES: Submit your comments, identified by Docket ID Number EPA-
R01-OAR-2010-0445 by one of the following methods:
    1. http://www.regulations.gov: Follow the on-line instructions for
submitting comments.
    2. E-mail<EMAIL_ADDRESS>    3. Fax:<PHONE_NUMBER>.
    4. Mail: ``Docket Identification Number EPA-R01-OAR-2010-0445'',
Anne Arnold, U.S. Environmental Protection Agency, EPA New England
Regional Office, Office of Ecosystem Protection, Air Quality Planning
Unit, 5 Post Office Square--Suite 100, (Mail code OEP05-2), Boston, MA
02109-3912.
    5. Hand Delivery or Courier. Deliver your comments to: Anne Arnold,
Manager, Air Quality Planning Unit, U.S. Environmental Protection
Agency, EPA New England Regional Office, Office of Ecosystem
Protection, Air Quality Planning Unit, 5 Post Office Square--Suite 100,
(mail code OEP05-2), Boston, MA 02109-3912. Such deliveries are only
accepted during the Regional Office's normal hours of operation. The
Regional Office's official hours of business are Monday through Friday,
8:30 to 4:30, excluding legal holidays.
    Instructions: Direct your comments to Docket ID No. EPA-R01-OAR-
2010-0445. EPA's policy is that all comments received will be included
in the public docket without change and may be made available online at
http://www.regulations.gov, including any personal information
provided, unless the comment includes information claimed to be
Confidential Business Information (CBI) or other information whose
disclosure is restricted by statute. Do not submit through http://www.regulations.gov, or e-mail, information that you consider to be CBI
or otherwise protected. The http://www.regulations.gov Web site is an
``anonymous access'' system, which means EPA will not know your
identity or contact information unless you provide it in the body of
your comment. If you send an e-mail comment directly to EPA without
going through http://www.regulations.gov your e-mail address will be
automatically captured and included as part of the comment that is
placed in the public docket and made available on the Internet. If you
submit an electronic comment, EPA recommends that you include your name
and other contact information in the body of your comment and with any
disk or CD-ROM you submit. If EPA cannot read your comment due to
technical difficulties and cannot contact you for clarification, EPA
may not be able to consider your comment. Electronic files should avoid
the use of special characters, any form of encryption, and be free of
any defects or viruses.
    Docket: All documents in the electronic docket are listed in the
http://www.regulations.gov index. Although listed in the index, some
information is not publicly available, i.e., CBI or other information
whose disclosure is restricted by statute. Certain other material, such
as copyrighted material, is not placed on the Internet and will be
publicly available only in hard copy form. Publicly available docket
materials are available either electronically in http://www.regulations.gov or in hard copy at Office of Ecosystem Protection,
U.S. Environmental Protection Agency, EPA New England Regional Office,
Office of Ecosystem Protection, Air Quality Planning Unit, 5 Post
Office Square--Suite 100, Boston, MA. EPA requests that if at all
possible, you contact the contact listed in the FOR FURTHER INFORMATION
CONTACT section to schedule your inspection. The Regional Office's
official hours of business are Monday through Friday, 8:30 to 4:30,
excluding legal holidays.
    In addition, copies of the State submittal and EPA's technical
support document are also available for public inspection during normal
business hours, by appointment at the State Air Agency; Division of Air
Quality Control, Department of Environmental Protection, One Winter
Street, 8th Floor, Boston, MA 02108.

FOR FURTHER INFORMATION CONTACT: Anne K. McWilliams, Air Quality
Planning Unit, U.S. Environmental Protection Agency, EPA New England
Regional Office, Office of Ecosystem Protection, 5 Post Office Square--
Suite 100, (mail code OEP05-2), Boston, MA 02109-3912, telephone number
(617) 918-1697, fax number<PHONE_NUMBER>, e-mail
<EMAIL_ADDRESS>
SUPPLEMENTARY INFORMATION:

Table of Contents

I. Background and Purpose
II. What action is EPA taking?
III. Summary of SIP Revision
IV. EPA's Evaluation of the SIP Revision
V. Proposed Action
VI. Statutory and Executive Order Reviews

I. Background and Purpose

    On April 14, 2010, the Massachusetts Department of Environmental
Protection (DEP) submitted a revision to its State Implementation Plan
(SIP) for Massachusetts. The SIP revision consists of a minor
modification to the carbon monoxide (CO) maintenance plan for Lowell,
Massachusetts. (A redesignation request and a maintenance plan for the
Lowell CO nonattainment area were approved by EPA on February 19, 2002
(67 FR 7272).) The modification changes the triggering mechanism which
will be used by the State to determine if contingency measures need to
be implemented in Lowell.

II. What action is EPA taking?

    EPA is proposing to approve revisions to the Lowell carbon monoxide
maintenance plan submitted by the State of Massachusetts on April 14,
2010. Specifically, EPA is proposing approval of the State's
modification of the portion of the maintenance plan used to determine
when contingency measures need to be triggered to reduce CO
concentrations in Lowell. This proposed action, if finalized, would
allow the discontinuation of CO monitoring in the Lowell maintenance
area.
    Massachusetts's SIP revision and EPA's evaluation of this SIP
revision are discussed below. Additional details are also provided in a
memorandum dated January 24, 2011, entitled ``Technical Support
Document for Revision to the Carbon Monoxide Maintenance Plan for
Lowell, Massachusetts'' (TSD). The TSD and Massachusetts's submittal
are available in the docket supporting this action.

III. Summary of SIP Revision

    On April 14, 2010, the Massachusetts Department of Environmental
Protection submitted a SIP revision to EPA that contains a modification
to its CO maintenance plan for the Lowell CO maintenance area. The
modifications to the maintenance plan change the triggering mechanism
by which contingency measures would be implemented and will allow the
State to discontinue CO monitoring in the Lowell maintenance area. CO
concentrations measured in Lowell have been below the National Ambient
Air Quality Standard (NAAQS) for nearly 25 years, and in recent years,
maximum measured concentrations have been less than 30% of the 9 parts
per million (ppm) 8-hour CO standard.\1\ In this SIP revision, the
State of Massachusetts is establishing an alternative triggering
mechanism, which will rely on CO data from a nearby CO monitor in
Worcester, Massachusetts.
---------------------------------------------------------------------------

    \1\ On January 28, 2011, EPA proposed to retain the existing CO
standard. In this action, EPA also proposed an increase in near-road
CO monitoring. Due to the low CO concentrations recorded at the
Lowell monitor and the applicable monitor siting criteria, this
monitor would not meet the requirements for a near-road monitor.
---------------------------------------------------------------------------

    Under the current maintenance plan, contingency measures in Lowell
are triggered when a violation of the CO NAAQS is measured in Lowell.
Under the revised maintenance plan, Massachusetts will rely on data
from the Worcester CO monitor to determine when and if monitoring will
be reestablished in the Lowell maintenance area, and, in some
circumstances, when contingency measures will be triggered in the
Lowell maintenance area.
    If this proposal is finalized, Massachusetts will discontinue CO
monitoring in Lowell. Massachusetts DEP will continue to collect and
review CO monitoring data from nearby Worcester, MA on an on-going
basis. In the event the second highest CO concentration in any calendar
year monitored in Worcester reaches 75 percent of the Federal 1-hour or
8-hour NAAQS for CO (35 and 9 ppm, respectively), Massachusetts will,
within 9 months of recording such concentrations, re-establish a CO
monitoring site in Lowell consistent with EPA siting criteria, and
resume analyzing and reporting those data. Massachusetts will continue
to commit to implement its contingency program in Lowell in the event
that a CO violation (the ``contingency trigger'') is monitored at the
re-established Lowell monitoring site at any time during the
maintenance period and to consider one or more of the other EPA-
approved measures listed in the 2001 Maintenance Plan if necessary to
reduce CO levels.
    If the Worcester CO monitor measures a violation of either the
Federal 1-hour or 8-hour NAAQS for CO, the contingency measures in 2001
Maintenance Plan for Lowell will be implemented in Lowell, as well as
triggering contingency measures in Worcester under the terms of the
existing Maintenance Plan for Worcester, until a re-established Lowell
CO monitor shows that the area is attainment of the CO standard.
    When implementing contingency measures, Massachusetts will review
and implement the measures necessary to remedy the violation, including
transportation control measures (TCM) or other additional vehicle or
fuel controls.

IV. EPA's Evaluation of the SIP Revision

    EPA agrees that the mechanism described above represents an
acceptable contingency triggering mechanism for the Lowell CO
maintenance plan. If the proposed approval of this revised triggering
mechanism is finalized, Massachusetts DEP will be allowed to
discontinue monitoring in the Lowell area, which we believe is
appropriate for this area which is currently measuring concentrations
well below the 1-hour and 8-hour CO NAAQS. Under this plan, we believe
air quality goals can be maintained, and State monitoring resources
conserved.
    On October 17, 2006, EPA published a final monitoring rule revising
minimum monitoring requirements, which was codified in 40 CFR part 58.
(See 71 FR 61236.) That rule explicitly recognized that, in some cases
where measured levels of pollutants are low, shutting down certain CO
monitors may be allowed without revising the SIP. (See 40 CFR
58.14(c)(1)-(6).) The rule, however, also explicitly provides that if a
monitor is the only monitor in the area, and it serves as a trigger to
implement a contingency measure in an EPA-approved maintenance plan,
then the monitor may not be discontinued. (See 40 CFR 58.14(c)(1).)
Rather, in this case the maintenance plan would need to be revised, and
the trigger replaced. (See 71 FR 61250 and 71 FR 61301.)
    As described above, this action is proposing to approve a change to
the mechanism that Massachusetts will use to determine when contingency
measures need to be triggered to reduce CO concentrations in Lowell.
Previously, the State would implement a contingency measure based on
concentrations of CO monitored in Lowell. In light of the fact that
Lowell CO concentrations have been well below the standard for some
time, the State is looking to conserve resources. Massachusetts DEP
wants to use its CO monitor in Worcester, a nearby city, to aid in
determining if Lowell has a CO problem. Lowell and Worcester are
located 42 miles apart. Worcester (population 175,011) \2\ is somewhat
larger than Lowell (population

103,615) \3\, so its CO concentrations can be expected to be slightly
higher due to greater motor vehicle emissions. CO concentrations in
Lowell and Worcester have tracked very closely for many years. (The TSD
provides a comparison of the data collected at the Lowell and Worcester
CO monitors over the last twenty-five years.) Both cities were
designated nonattainment in 1990 for CO ``by operation of law,'' though
both had design values below the standard at that time. In both cases,
only the city itself was designated nonattainment since data did not
support an expansion of the nonattainment area. Both cities were
redesignated to attainment in 2000, and both have measured CO
concentrations well below the standard since that time.
---------------------------------------------------------------------------

    \2\ U.S. Census Bureau, 2008 Population Estimates.
    \3\ Ibid.
---------------------------------------------------------------------------

    In order to conserve resources, the State is seeking to discontinue
monitoring in Lowell since current air quality levels do not warrant
the additional expense of running a CO monitor in this area. The State
has committed to continue CO monitoring in Worcester, and will
reestablish CO monitoring in Lowell if air quality in Worcester
degrades significantly. In Massachusetts (as in many other places), CO
is primarily emitted by on and off-road mobile sources. Starting in the
early 1970s, EPA has set national standards that have considerably
reduced emissions of CO and other pollutants from motor vehicles,
including tailpipe emissions, new vehicle technologies, and clean fuels
programs. Moreover, the Massachusetts SIP requires that new or modified
large stationary sources demonstrate that their emissions will not
cause an exceedance of any NAAQS. Finally, growth is not likely to
result in increased CO levels because the CO reductions described above
have occurred even as vehicle miles traveled (VMT) have increased. (See
VMT data in TSD.) For this reason, EPA believes that it is unlikely
that the Lowell or Worcester maintenance area will exceed the CO NAAQS
again. Thus, we believe that the revisions that Massachusetts has made
to the Lowell maintenance plan will continue to protect the citizens of
Massachusetts from high CO concentrations, and also conserve resources.
    EPA is proposing to approve the Massachusetts SIP revision for the
Carbon Monoxide Maintenance Plan for Lowell, which was submitted on
April 14, 2010. EPA is soliciting public comments on the issues
discussed in this notice or on other relevant matters. These comments
will be considered before taking final action. Interested parties may
participate in the Federal rulemaking procedure by submitting written
comments to the EPA New England Regional Office listed in the ADDRESSES
section of this Federal Register.

V. Proposed Action

    EPA is proposing to approve the revisions to the Lowell CO
maintenance plan submitted by the State of Massachusetts on April 14,
2010. Specifically, EPA is proposing approval of the State's request to
modify the portion of the maintenance plan used to determine when
contingency measures need to be implemented in Lowell. As described in
more detail above, if this proposal is finalized, the State will shut
down the Lowell CO monitor and rely on data from the CO monitor in
Worcester to determine when and if monitoring will be reestablished in
the Lowell maintenance area, and, in some circumstances, when
contingency measures will be triggered in the Lowell maintenance area.

VI. Statutory and Executive Order Reviews

    Under the Clean Air Act, the Administrator is required to approve a
SIP submission that complies with the provisions of the Act and
applicable Federal regulations. 42 U.S.C. 7410(k); 40 CFR 52.02(a).
Thus, in reviewing SIP submissions, EPA's role is to approve State
choices, provided that they meet the criteria of the Clean Air Act.
Accordingly, this proposed action merely approves State law as meeting
Federal requirements and does not impose additional requirements beyond
those imposed by State law. For that reason, this proposed action:
     Is not a ``significant regulatory action'' subject to
review by the Office of Management and Budget under Executive Order
12866 (58 FR 51735, October 4, 1993);
     Does not impose an information collection burden under the
provisions of the Paperwork Reduction Act (44 U.S.C. 3501 et seq.);
     Is certified as not having a significant economic impact
on a substantial number of small entities under the Regulatory
Flexibility Act (5 U.S.C. 601 et seq.);
     Does not contain any unfunded mandate or significantly or
uniquely affect small governments, as described in the Unfunded
Mandates Reform Act of 1995 (Pub. L. 104-4);
     Does not have Federalism implications as specified in
Executive Order 13132 (64 FR 43255, August 10, 1999);
     Is not an economically significant regulatory action based
on health or safety risks subject to Executive Order 13045 (62 FR
19885, April 23, 1997);
     Is not a significant regulatory action subject to
Executive Order 13211 (66 FR 28355, May 22, 2001);
     Is not subject to requirements of Section 12(d) of the
National Technology Transfer and Advancement Act of 1995 (15 U.S.C. 272
note) because application of those requirements would be inconsistent
with the Clean Air Act; and
     Does not provide EPA with the discretionary authority to
address, as appropriate, disproportionate human health or environmental
effects, using practicable and legally permissible methods, under
Executive Order 12898 (59 FR 7629, February 16, 1994).
    In addition, this rule does not have Tribal implications as
specified by Executive Order 13175 (65 FR 67249, November 9, 2000),
because the SIP is not approved to apply in Indian country located in
the State, and EPA notes that it will not impose substantial direct
costs on Tribal governments or preempt Tribal law.

List of Subjects in 40 CFR Part 52

    Environmental protection, Air pollution control, Carbon monoxide,
Intergovernmental relations, Reporting and recordkeeping requirements.

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

    Dated: February 8, 2011.
H. Curtis Spalding,
Regional Administrator, EPA New England.
[FR Doc. 2011-3613 Filed 2-16-11; 8:45 am]
BILLING CODE 6560-50-P


[Federal Register Volume 85, Number 134 (Monday, July 13, 2020)]
[Notices]
[Pages 41989-41990]
[FR Doc No: 2020-14998]

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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2019-D-0358]

Cancer Clinical Trial Eligibility Criteria: Minimum Age
Considerations for Inclusion of Pediatric Patients; Guidance for
Industry and Institutional Review Boards; 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 final guidance for industry and institutional
review boards (IRBs) entitled ``Cancer Clinical Trial Eligibility
Criteria: Minimum Age Considerations for Inclusion of Pediatric
Patients.'' This guidance is one in a series of guidances that provide
recommendations regarding eligibility criteria for clinical trials of
drugs or biological products regulated by the Center for Drug
Evaluation and Research (CDER) and the Center for Biologics Evaluation
and Research (CBER) for the treatment of cancer. Specifically, this
guidance includes recommendations on the inclusion of pediatric
patients (i.e., children and adolescents) in clinical trials for cancer
treatments. This guidance finalizes the draft guidance entitled
``Cancer Clinical Trial Eligibility Criteria: Minimum Age for Pediatric
Patients'' that published on March 13, 2019.

DATES: The announcement of the guidance is published in the Federal
Register on July 13, 2020.

ADDRESSES: You may submit either electronic or written comments on
Agency guidances 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-2019-D-0358 for ``Cancer Clinical Trial Eligibility Criteria:
Minimum Age Considerations for Inclusion of Pediatric Patients.''
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 this 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; or to the Office of
Communication, Outreach and Development, Center for Biologics
Evaluation and Research, Food and Drug Administration, 10903 New
Hampshire Ave., Bldg. 71, Rm. 3128, 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 guidance document.

FOR FURTHER INFORMATION CONTACT: Julia Beaver, Center for Drug
Evaluation and Research, Food and Drug Administration, 10903 New
Hampshire Ave., Bldg. 22, Rm. 2100, Silver Spring, MD 20993-0002, 240-
402-0489; or Stephen Ripley, Center for Biologics Evaluation and
Research, Food and Drug Administration, 10903 New Hampshire Ave., Bldg.
71, Rm. 7301, Silver Spring, MD 20993-0002,<PHONE_NUMBER>.

SUPPLEMENTARY INFORMATION:

I. Background

    FDA is announcing the availability of a guidance for industry and
IRBs entitled ``Cancer Clinical Trial Eligibility Criteria: Minimum Age
Considerations for Inclusion of Pediatric Patients.'' This guidance
provides

recommendations on the inclusion of pediatric patients in clinical
trials of drugs or biological products regulated by CDER and CBER for
the treatment of cancer.
    A clinical trial's eligibility criteria (for inclusion and
exclusion) are essential components of the trial, defining the
characteristics of the study population. Because there is variability
in investigational drugs and trial objectives, eligibility criteria
should be developed, taking into consideration the mechanism of action
of the drug, the targeted disease or patient population, the
anticipated safety of the investigational drug, the availability of
adequate safety data, and the ability to recruit trial participants
from the patient population to meet the objectives of the clinical
trial. However, some eligibility criteria have become commonly accepted
over time or used as a template across trials without clear scientific
or clinical rationale. Unnecessarily restrictive eligibility criteria
may slow patient accrual, limit patients' access to clinical trials,
and lead to trial results that do not fully represent treatment effects
in the patient population that will ultimately use the drug. Broadening
cancer trial eligibility criteria can maximize the generalizability of
trial results and the ability to understand the therapy's benefit-risk
profile across the patient population likely to use the drug in
clinical practice and should be considered to avoid jeopardizing
patient safety. Early evaluation and development of potentially
effective drugs, particularly targeted drugs, in pediatric patients may
provide information on safe and effective use, therefore reducing risks
associated with off label use, and accelerate the development of
effective, innovative therapies for pediatric patients.
    The guidance includes recommendations regarding minimum age
eligibility criteria and addresses specific situations in which the
inclusion of children (for the purposes of this guidance, ages 2 years
to younger than 12 years) and adolescents (for the purposes of this
guidance, ages 12 years to 17 years) is appropriate in cancer trials
(i.e., based on disease biology and clinical course, molecular target
of the investigational drug, and/or its molecular mechanism). In
addition, the guidance includes ethical and regulatory considerations
for including pediatric patients in such trials.
    In the Federal Register of March 13, 2019 (84 FR 9130), FDA
announced the availability of the draft guidance entitled ``Cancer
Clinical Trial Eligibility Criteria: Minimum Age for Pediatric
Patients.'' FDA received comments and considered those comments as the
guidance was finalized. The final guidance recommends specific issues
to discuss with FDA and provides additional recommendations for
providing care in pediatric oncology trials. In addition, the final
guidance includes additional information for clarification, for example
regarding types of evidence that could support inclusion of children
and dosing considerations in early phase trials.
    This guidance is being issued consistent with FDA's good guidance
practices regulation (21 CFR 10.115). The guidance represents the
current thinking of FDA on ``Cancer Clinical Trial Eligibility
Criteria: Minimum Age Considerations for Inclusion of Pediatric
Patients.'' 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

    This guidance refers to previously approved FDA collections of
information. These collections of information are subject to review by
the Office of Management and Budget (OMB) under the Paperwork Reduction
Act of 1995 (44 U.S.C. 3501-3521). The collections of information in 21
CFR part 312 have been approved under OMB control number 0910-0014; the
collections of information in 21 CFR 201.56 and 201.57 have been
approved under OMB control number 0910-0572.

III. Electronic Access

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

    Dated: July 7, 2020.
Lowell J. Schiller,
Principal Associate Commissioner for Policy.
[FR Doc. 2020-14998 Filed 7-10-20; 8:45 am]
BILLING CODE 4164-01-P


[Federal Register Volume 78, Number 103 (Wednesday, May 29, 2013)]
[Notices]
[Pages 32250-32251]
[FR Doc No: 2013-12780]

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ENVIRONMENTAL PROTECTION AGENCY

[EPA-HQ-OPP-2013-0036; FRL-9387-5]

CDM Smith and Dynamac Corp; Transfer of Data

AGENCY: Environmental Protection Agency (EPA).

ACTION: Notice.

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

SUMMARY: This notice announces that pesticide related information
submitted to EPA's Office of Pesticide Programs pursuant to the Federal
Insecticide, Fungicide, and Rodenticide Act (FIFRA) and the Federal
Food, Drug, and Cosmetic Act (FFDCA), including information that may
have been claimed as Confidential Business Information (CBI) by the
submitter, will be transferred to CDM Smith and its subcontractor,
Dynamac Corp, in accordance with 40 CFR 2.307(h)(3) and 2.308(i)(2).
CDM Smith and its subcontractor, Dynamac Corp, have been awarded a
contract to perform work for OPP, and access to this information will
enable CDM Smith and its subcontractor, Dynamac Corp, to fulfill the
obligations of the contract.

DATES: CDM Smith and its subcontractor, Dynamac Corp, will be given
access to this information on or before June 3, 2013.

FOR FURTHER INFORMATION CONTACT: Mario Steadman, Information Technology
and Resources Management Division (7502P), Office of Pesticide
Programs, Environmental Protection Agency, 1200 Pennsylvania Ave. NW.,
Washington, DC 20460-0001; telephone number:<PHONE_NUMBER>,
<EMAIL_ADDRESS>
SUPPLEMENTARY INFORMATION:

I. General Information

A. Does this action apply to me?

    This action applies to the public in general. As such, the Agency
has not attempted to describe all the specific

entities that may be affected by this action. If you have any questions
regarding the applicability of this action to a particular entity,
consult the person listed under FOR FURTHER INFORMATION CONTACT.

B. How can I get copies of this document and other related information?

    EPA has established a docket for this action under docket
identification (ID) number EPA-HQ-OPP-2013-0036. Publicly available
docket materials are available either in the electronic docket at
http://www.regulations.gov, or, if only available in hard copy, at the
Office of Pesticide Programs (OPP) Regulatory Public Docket in Rm. S-
4400, One Potomac Yard (South Bldg.), 2777 S. Crystal Dr., Arlington,
VA. The hours of operation of this Docket Facility are from 8:30 a.m.
to 4 p.m., Monday through Friday, excluding legal holidays. The Docket
Facility telephone number is<PHONE_NUMBER>.

II. Contractor Requirements

    Under Contract No. EP-W-11-020, CDM Smith and its subcontractor,
Dynamac Corp, will perform support OPP in four general areas: Reviewing
and evaluating studies provided by the registrants or found in open
literature searches; producing assessments; reviewing submitted risk
assessments; and developing or improving risk assessment methods. In
addition, support may be required to provide training for EPA staff on
issues related to the science and methods of risk assessment. Workshop
organization and facilitation may also be required.
    OPP has determined that access by CDM Smith and its subcontractor,
Dynamac Corp, to information on all pesticide chemicals is necessary
for the performance of this contract.
    Some of this information may be entitled to confidential treatment.
The information has been submitted to EPA under sections 3, 4, 6, and 7
of FIFRA and under sections 408 and 409 of FFDCA.
    In accordance with the requirements of 40 CFR 2.307(h)(2), the
contract with CDM Smith and its subcontractor, Dynamac Corp, prohibits
use of the information for any purpose not specified in the contract;
prohibits disclosure of the information to a third party without prior
written approval from the Agency; and requires that each official and
employee of the contractor sign an agreement to protect the information
from unauthorized release and to handle it in accordance with the FIFRA
Information Security Manual. In addition, CDM Smith and its
subcontractor, Dynamac Corp, are required to submit for EPA approval a
security plan under which any CBI will be secured and protected against
unauthorized release or compromise. No information will be provided to
CDM Smith and its subcontractor, Dynamac Corp, until the requirements
in this document have been fully satisfied. Records of information
provided to CDM Smith and its subcontractor, Dynamac Corp, will be
maintained by EPA Project Officers for this contract. All information
supplied to CDM Smith and its subcontractor, Dynamac Corp, by EPA for
use in connection with this contract will be returned to EPA when CDM
Smith and its subcontractor, Dynamac Corp, have completed their work.

List of Subjects

    Environmental protection, Business and industry, Government
contracts, Government property, Pesticides and pests, Security
measures.

    Dated: May 14, 2013.
Oscar Morales,
Director, Information Technology and Resources Management Division,
Office of Pesticide Programs.
[FR Doc. 2013-12780 Filed 5-28-13; 8:45 am]
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[Federal Register Volume 86, Number 50 (Wednesday, March 17, 2021)]
[Notices]
[Pages 14624-14625]
[FR Doc No: 2021-05516]

=======================================================================
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ENVIRONMENTAL PROTECTION AGENCY

[EPA-HQ-ORD-2015-0611; FRL-10020-37-ORD]

Board of Scientific Counselors (BOSC) Sustainable and Health
Communities Subcommittee Meeting--March 2021

AGENCY: Environmental Protection Agency (EPA).

ACTION: Notice of public meeting.

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SUMMARY: The Environmental Protection Agency (EPA), Office of Research
and Development (ORD), gives notice of a series of virtual meetings of
the Board of Scientific Counselors (BOSC) Sustainable and Health
Communities (SHC) Subcommittee to discuss contaminated sites, including
mine waste, solvent vapor intrusion, underground storage tanks, and
lead.

DATES:
    1. The initial meeting will be held over three days via
videoconference:
    a. Tuesday, March 30, 2021, from 12 p.m. to 5 p.m. (EDT);
    b. Wednesday, March 31, 2021, from 12 p.m. to 5 p.m. (EDT); and
    c. Thursday, April 1, 2021, from 12 p.m. to 5 p.m. (EDT).
    Attendees must register by March 29, 2021.
    2. A BOSC deliberation will be held on April 16, 2021, from 11 a.m.
to 2 p.m. (EDT).
    Attendees must register by April 15, 2021.
    3. A final summary teleconference will be held on April 27, 2021,
from 2 p.m. to 5 p.m. (EDT).
    Attendees must register by April 26, 2021.
    Meeting times are subject to change. This series of meetings are
open to the public. Comments must be received by March 29, 2021, to be
considered by the subcommittee. Requests for the draft agenda or making
a presentation at the meeting will be accepted until March 29, 2021.

ADDRESSES: Instructions on how to connect to the videoconference will
be provided upon registration at https://www.eventbrite.com/e/us-epa-bosc-sustainable-and-healthy-communities-subcommittee-meeting-tickets-131425620569.

    Submit your comments to Docket ID No. EPA-HQ-ORD-2015-0611 by one
of the following methods:
     www.regulations.gov: Follow the online instructions for
submitting comments.
    [ssquf] Note: comments submitted to the www.regulations.gov website
are anonymous unless identifying information is included in the body of
the comment.
     Email: Send comments by electronic mail (email) to:
<EMAIL_ADDRESS>Attention Docket ID No. EPA-HQ-ORD-2015-0611.
    [ssquf] Note: comments submitted via email are not anonymous. The
sender's email will be included in the body of the comment and placed
in the public docket which is made available on the internet.
    Instructions: All comments received, including any personal
information provided, will be included in the public docket without
change and may be made available online at www.regulations.gov.
Information claimed to be Confidential Business Information (CBI) or
other information whose disclosure is restricted by statute will not be
included in the public docket, and should not be submitted through
www.regulations.gov or email. For additional information about the
EPA's public docket visit the EPA Docket Center homepage at http://www.epa.gov/dockets/.
    Public Docket: Publicly available docket materials may be accessed
Online at www.regulations.gov.
    Copyrighted materials in the docket are only available via hard
copy. The telephone number for the ORD Docket Center is<PHONE_NUMBER>.

FOR FURTHER INFORMATION CONTACT: The Designated Federal Officer (DFO),
Tom Tracy, via phone/voicemail at:<PHONE_NUMBER>; or via email at:
<EMAIL_ADDRESS>    Any member of the public interested in receiving a draft agenda,
attending the meeting, or making a presentation at the meeting should
contact Tom Tracy no later than March 29, 2021.

SUPPLEMENTARY INFORMATION: The Board of Scientific Counselors (BOSC) is
a federal advisory committee that provides advice and recommendations
to EPA's Office of Research and Development on technical and management
issues of its research programs. The meeting agenda and materials will
be posted to https://www.epa.gov/bosc.
    Proposed agenda items for the meeting include, but are not limited
to, the following: Contaminated sites, including mine waste, solvent
vapor intrusion, underground storage tanks, and lead.
    Information on Services Available: For information on translation
services, access, or services for individuals with disabilities, please
contact Tom Tracy at<PHONE_NUMBER> or<EMAIL_ADDRESS>To request
accommodation of a disability, please contact Tom Tracy at least ten
days prior to the meeting to give the EPA adequate time to process your
request.

    Authority: Pub. L. 92-463, 1, Oct. 6, 1972, 86 Stat. 770.

Mary Ross,
Director, Office of Science Advisor, Policy and Engagement.
[FR Doc. 2021-05516 Filed 3-16-21; 8:45 am]
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[Federal Register Volume 77, Number 248 (Thursday, December 27, 2012)]
[Rules and Regulations]
[Pages 76228-76230]
[FR Doc No: 2012-30369]

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DEPARTMENT OF TRANSPORTATION

Federal Aviation Administration

14 CFR Part 39

[Docket No. FAA-2012-0995; Directorate Identifier 2012-NM-056-AD;
Amendment 39-17291; AD 2012-25-10]
RIN 2120-AA64

Airworthiness Directives; Airbus Airplanes

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

ACTION: Final rule.

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

SUMMARY: We are adopting a new airworthiness directive (AD) for all
Airbus Model A330-300 series airplanes and Model A340-200 and -300
series airplanes. This AD was prompted by reports that, during a flight
test, several spoiler servo-controls (SSCs) did not remain locked in
the retracted position (hydraulic locking function) after manual
depressurization of the corresponding hydraulic circuit. Loss of that
locking function--which is ensured by a blocking valve--was caused by
an internal leak from a sheared seal on the blocking valve. This AD
requires inspecting to determine if certain SSCs are installed,
performing an operational test of any affected SSC, and replacing if
necessary. We are issuing this AD to prevent loss of the hydraulic
locking function during take-off and go-around phases, which, in
combination with malfunction of one engine, could result in reduced
controllability of the airplane.

DATES: This AD becomes effective January 31, 2013.
    The Director of the Federal Register approved the incorporation by
reference of certain publications listed in this AD as of January 31,
2013.

ADDRESSES: You may examine the AD docket on the Internet at http://www.regulations.gov or in person at the U.S. Department of
Transportation, Docket Operations, M-30, West Building Ground Floor,
Room W12-140, 1200 New Jersey Avenue SE., Washington, DC.

FOR FURTHER INFORMATION CONTACT: Vladimir Ulyanov, Aerospace Engineer,
International Branch, ANM-116, Transport Airplane Directorate, FAA,
1601 Lind Avenue SW., Renton, Washington 98057-3356; telephone (425)
227-1138; fax<PHONE_NUMBER>.

SUPPLEMENTARY INFORMATION:

Discussion

    We issued a notice of proposed rulemaking (NPRM) to amend 14 CFR
part 39 to include an AD that would apply to the specified products.
That NPRM was published in the Federal Register on September 20, 2012
(77 FR 58327). That NPRM proposed to correct an unsafe condition for
the specified products. The Mandatory Continuing Airworthiness
Information (MCAI) states:

    Two operators have reported that several spoilers did not remain
locked in the retracted position (lifted up without order) after
manual depressurization of the corresponding hydraulic circuit
during flight test.
    Subsequent checks on ground confirmed that, for each affected
spoiler surface, the spoiler was fitted with one MZ-type Spoiler
Servo Control (SSC) (Part Number (P/N) MZ4339390-12 or P/N
MZ4306000-12).
    The results of the investigations on the affected SSCs, done by
the supplier, revealed that the loss of the hydraulic locking
function--which is ensured by a blocking valve--was due to an
internal leakage caused by a sheared seal. This seal is installed at
the left end of the blocking valve.
    During the on-wing modification of the maintenance cover,
blocking valve movement may have damaged the seal on the outer
diameter of the blocking valve assembly, causing the loss of the
hydraulic locking function.
    This condition, if not detected and corrected, if occurring
during take-off and go-around phases in combination with one engine
inoperative, could jeopardize the aeroplane safe flight.
    For the reasons described above, this [EASA] AD requires the
identification of the installed SSCs, to perform an operational test
of the hydraulic locking function of the affected SSCs and to
accomplish the applicable corrective actions if any discrepancy is
detected during the operational test. This [EASA] AD also requires
reporting operational test results to Airbus.

You may obtain further information by examining the MCAI in the AD
docket.

Comments

    We gave the public the opportunity to participate in developing
this AD. We received no comments on the NPRM (77 FR 58327, September
20, 2012) or on the determination of the cost to the public.

Conclusion

    We reviewed the available data and determined that air safety and
the public interest require adopting the AD as proposed.

Costs of Compliance

    We estimate that this AD will affect 61 products of U.S. registry.
We also estimate that it will take up to 7 work-hours per product to
comply with the basic requirements of this AD. The average labor rate
is $85 per work-hour. Based on these figures, we estimate the cost of
the AD on U.S. operators to be $36,295, or $595 per product.
    In addition, we estimate that any necessary follow-on actions would
take about 36 work-hours and require parts costing $34,928, for a cost
of $37,988 per affected SSC. We have no way of determining the number
of products that may need these actions.

Authority for This Rulemaking

    Title 49 of the United States Code specifies the FAA's authority to
issue rules on aviation safety. Subtitle I, section 106, describes the
authority of the FAA Administrator. ``Subtitle VII: Aviation
Programs,'' describes in more detail the scope of the Agency's
authority.
    We are issuing this rulemaking under the authority described in
``Subtitle VII, Part A, Subpart III, Section 44701: General
requirements.'' Under that section, Congress charges the FAA with
promoting safe flight of civil aircraft in air commerce by prescribing
regulations for practices, methods, and procedures the Administrator
finds necessary for safety in air commerce. This regulation is within
the scope of that authority because it addresses an unsafe condition
that is likely to exist or develop on products identified in this
rulemaking action.

Regulatory Findings

    We determined that this AD will not have federalism implications
under Executive Order 13132. This AD will not have a substantial direct
effect 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.
    For the reasons discussed above, I certify that this AD:
    1. Is not a ``significant regulatory action'' under Executive Order
12866;
    2. Is not a ``significant rule'' under the DOT Regulatory Policies
and Procedures (44 FR 11034, February 26, 1979);
    3. Will not affect intrastate aviation in Alaska; and
    4. Will not have a significant economic impact, positive or
negative, on a substantial number of small entities under the criteria
of the Regulatory Flexibility Act.
    We prepared a regulatory evaluation of the estimated costs to
comply with this AD and placed it in the AD docket.

Examining the AD Docket

    You may examine the AD docket on the Internet at http://

www.regulations.gov; or in person at the Docket Operations office
between 9 a.m. and 5 p.m., Monday through Friday, except Federal
holidays. The AD docket contains the NPRM (77 FR 58327, September 20,
2012), the regulatory evaluation, any comments received, and other
information. The street address for the Docket Operations office
(telephone<PHONE_NUMBER>) is in the ADDRESSES section. Comments will
be available in the AD docket shortly after receipt.

List of Subjects in 14 CFR Part 39

    Air transportation, Aircraft, Aviation safety, Incorporation by
reference, Safety.

Adoption of the Amendment

    Accordingly, under the authority delegated to me by the
Administrator, the FAA amends 14 CFR part 39 as follows:

PART 39--AIRWORTHINESS DIRECTIVES

0
1. The authority citation for part 39 continues to read as follows:

    Authority: 49 U.S.C. 106(g), 40113, 44701.

Sec.  39.13  [Amended]

0
2. The FAA amends Sec.  39.13 by adding the following new AD:

2012-25-10 Airbus: Amendment 39-17291. Docket No. FAA-2012-0995;
Directorate Identifier 2012-NM-056-AD.

(a) Effective Date

    This airworthiness directive (AD) becomes effective January 31,
2013.

(b) Affected ADs

    None.

(c) Applicability

    This AD applies to all Airbus Model A330-301, -302, -303, -321,
-322, -323, -341, -342, and -343 airplanes; and Model A340-211, -
212, -213, -311, -312, and -313 airplanes; certificated in any
category; all manufacturer serial numbers.

(d) Subject

    Air Transport Association (ATA) of America Code 27: Flight
controls.

(e) Reason

    This AD was prompted by reports that, during flight test,
several spoiler servo-controls (SSCs) did not remain locked in the
retracted position (hydraulic locking function) after manual
depressurization of the corresponding hydraulic circuit. Loss of
that locking function--which is ensured by a blocking valve--was
caused by an internal leak from a sheared seal on the blocking
valve. We are issuing this AD to prevent loss of the hydraulic
locking function during take-off and go-around phases, which, in
combination with malfunction of one engine, could result in reduced
controllability of the airplane.

(f) Compliance

    You are responsible for having the actions required by this AD
performed within the compliance times specified, unless the actions
have already been done.

(g) Actions

    Within 90 days after the effective date of this AD: Inspect to
determine the part number (P/N) of all SSCs installed, in accordance
with Airbus All Operators Telex (AOT) A330-27A3185 (for Model A330-
300 series airplanes) or A340-27A4181 (for Model A340-200 and -300
series airplanes), both dated January 4, 2012. A review of airplane
maintenance records is acceptable in lieu of the inspection to
identify the part number of the SSC installed, provided that part
number can be conclusively determined from that review.
    (1) For any SSC having P/N MZ4339390-12 or P/N MZ4306000-12 (MZ-
type): Within 90 days after identification of the part, perform an
operational test of the hydraulic locking function at each position
fitted with an MZ-type SSC, in accordance with Airbus AOT A330-
27A3185 (for Model A330-300 series airplanes) or A340-27A4181 (for
Model A340-200 and -300 series airplanes), both dated January 4,
2012.
    (2) If any discrepancy is detected during the operational test
specified in paragraph (g)(1) of this AD, or if the test fails,
before further flight, replace the affected SSC with a new or
serviceable SSC, in accordance with Airbus AOT A330-27A3185 (for
Model A330-300 series airplanes) or A340-27A4181 (for Model A340-200
and -300 series airplanes), both dated January 4, 2012.

(h) Reporting to Airbus

    Submit a report of the findings of the operational test required
by paragraph (g)(1) of this AD (both positive and negative) to
Airbus, Customer Services, Engineering and Technical Support, 1 Rond
Point Maurice Bellonte, 31707 Blagnac Cedex France, Attn: Daniel
Lopez-Fernandez, SEEL6; fax: (+33) 5 61 93 04 52; email:
<EMAIL_ADDRESS>at the applicable time specified
in paragraph (h)(1) or (h)(2) of this AD.
    (1) If the test was done on or after the effective date of this
AD: Submit the report within 30 days after the test.
    (2) If the test was done before the effective date of this AD:
Submit the report within 30 days after the effective date of this
AD.

(i) Other FAA AD Provisions

    The following provisions also apply to this AD:
    (1) Alternative Methods of Compliance (AMOCs): The Manager,
International Branch, ANM-116, Transport Airplane Directorate, FAA,
has the authority to approve AMOCs for this AD, if requested using
the procedures found in 14 CFR 39.19. In accordance with 14 CFR
39.19, send your request to your principal inspector or local Flight
Standards District Office, as appropriate. If sending information
directly to the International Branch, send it to ATTN: Vladimir
Ulyanov, Aerospace Engineer, International Branch, ANM-116,
Transport Airplane Directorate, FAA, 1601 Lind Avenue SW., Renton,
Washington 98057-3356; telephone<PHONE_NUMBER>; fax<PHONE_NUMBER>.
Information may be emailed to<EMAIL_ADDRESS>
Before using any approved AMOC, notify your appropriate principal
inspector, or lacking a principal inspector, the manager of the
local flight standards district office/certificate holding district
office. The AMOC approval letter must specifically reference this
AD.
    (2) Airworthy Product: For any requirement in this AD to obtain
corrective actions from a manufacturer or other source, use these
actions if they are FAA-approved. Corrective actions are considered
FAA-approved if they are approved by the State of Design Authority
(or their delegated agent). You are required to assure the product
is airworthy before it is returned to service.
    (3) Reporting Requirements: A federal agency may not conduct or
sponsor, and a person is not required to respond to, nor shall a
person be subject to a penalty for failure to comply with a
collection of information subject to the requirements of the
Paperwork Reduction Act unless that collection of information
displays a current valid OMB Control Number. The OMB Control Number
for this information collection is 2120-0056. Public reporting for
this collection of information is estimated to be approximately 5
minutes per response, including the time for reviewing instructions,
completing and reviewing the collection of information. All
responses to this collection of information are mandatory. Comments
concerning the accuracy of this burden and suggestions for reducing
the burden should be directed to the FAA at: 800 Independence Ave.
SW., Washington, DC 20591, Attn: Information Collection Clearance
Officer, AES-200.

(j) Related Information

    Refer to MCAI European Aviation Safety Agency Airworthiness
Directive 2012-0009, dated January 13, 2012, and the service
information specified in paragraph (j)(1) or (j)(2) of this AD, for
related information.
    (1) Airbus All Operators Telex (AOT) A330-27A3185, dated January
4, 2012.
    (2) Airbus AOT A340-27A4181, dated January 4, 2012.

(k) Material Incorporated by Reference

    (1) The Director of the Federal Register approved the
incorporation by reference (IBR) of the service information listed
in this paragraph under 5 U.S.C. 552(a) and 1 CFR part 51.
    (2) You must use this service information as applicable to do
the actions required by this AD, unless the AD specifies otherwise.
    (i) Airbus All Operators Telex A330-27A3185, dated January 4,
2012. The document number and issue date are identified on only the
first page of this document.
    (ii) Airbus All Operators Telex A340-27A4181, dated January 4,
2012. The document number and issue date are identified on only the
first page of this document.
    (3) For service information identified in this AD, contact
Airbus SAS--Airworthiness

Office--EAL, 1 Rond Point Maurice Bellonte, 31707 Blagnac Cedex,
France; telephone +33 5 61 93 36 96; fax +33 5 61 93 45 80; email
<EMAIL_ADDRESS>Internet http://www.airbus.com.
    (4) You may review copies of the service information at the FAA,
Transport Airplane Directorate, 1601 Lind Avenue SW., Renton, WA.
For information on the availability of this material at the FAA,
call<PHONE_NUMBER>.
    (5) You may view this service information that is incorporated
by reference at the National Archives and Records Administration
(NARA). For information on the availability of this material at
NARA, call<PHONE_NUMBER>, or go to: http://www.archives.gov/federal-register/cfr/ibr-locations.html.

    Issued in Renton, Washington, on December 7, 2012.
Kalene C. Yanamura,
Acting Manager, Transport Airplane Directorate, Aircraft Certification
Service.
[FR Doc. 2012-30369 Filed 12-26-12; 8:45 am]
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