(ii) For operating units that combust non-hazardous secondary materials that have been determined not to be solid waste pursuant to §241.3(b)(1) of this chapter, you must keep a record which documents how the secondary material meets each of the legitimacy criteria under §241.3(d)(1). If you combust a fuel that has been processed from a discarded non-hazardous secondary material pursuant to §241.3(b)(4) of this chapter, you must keep records as to how the operations that produced the fuel satisfies the definition of processing in §241.2 and each of the legitimacy criteria in §241.3(d)(1) of this chapter. If the fuel received a non-waste determination pursuant to the petition process submitted under §241.3(c) of this chapter, you must keep a record that documents how the fuel satisfies the requirements of the petition process. For operating units that combust non-hazardous secondary materials as fuel per §241.4, you must keep records documenting that the material is a listed non-waste under §241.4(a).
(iii) For each boiler required to conduct an energy assessment, you must keep a copy of the energy assessment report.
(iv) For each boiler subject to an emission limit in Table 1 to this subpart, you must also keep records of monthly fuel use by each boiler, including the type(s) of fuel and amount(s) used.
(v) You must keep records of days of operation by each boiler that meets the definition of seasonal boiler.
*	*	*	*	*
(d) Your records must be in a form suitable and readily available for expeditious review. You must keep each record for 5 years following the date of each recorded action. You must keep each record onsite or be accessible from a central location by computer or other means that instantly provide access at the site for at least 2 years after the date of each recorded action. You may keep the records off site for the remaining 3 years.
      (e)(1) Within 60 days after the date of completing each performance test(defined in §63.2) as required by this subpart you must submit the results of the performance tests, including any associated fuel analyses, required by this subpart to EPA's WebFIRE database by using CEDRI that is accessed through EPA's CDX (www.epa.gov/cdx). Performance test data must be submitted in the file format generated through use of EPA's Electronic Reporting Tool (ERT) (see http://www.epa.gov/ttn/chief/ert/index.html). Only data collected using test methods on the ERT website are subject to this requirement for submitting reports electronically to WebFIRE. Owners or operators who claim that some of the information being submitted for performance tests is confidential business information (CBI) must submit a complete ERT file including information claimed to be CBI on a compact disk or other commonly used electronic storage media (including, but not limited to, flash drives) to EPA. The electronic media must be clearly marked as CBI and mailed to U.S. EPA/OAPQS/CORE CBI Office, Attention: WebFIRE Administrator, MD C404-02, 4930 Old Page Rd., Durham, NC  27703. The same ERT file with the CBI omitted must be submitted to EPA via CDX as described earlier in this paragraph. At the discretion of the delegated authority, you must also submit these reports, including the confidential business information, to the delegated authority in the format specified by the delegated authority. For any performance test conducted using test methods that are not listed on the ERT website, the owner or operator shall submit the results of the performance test in paper submissions to the Administrator.
 (2) Within 60 days after the date of completing each CEMS performance evaluation test as defined in §63.2, you must submit relative accuracy test audit (RATA) data to EPA's CDX by using CEDRI in accordance with paragraph (h)(1) of this section.  Only RATA pollutants that can be documented with the ERT (as listed on the ERT website) are subject to this requirement. For any performance evaluations with no corresponding RATA pollutants listed on the ERT website, the owner or operator shall submit the results of the performance evaluation in paper submissions to the Administrator.
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(g) If you have switched fuels or made a physical change to the boiler, and this fuel switch or change resulted in the applicability of a different subcategory or a switch out of subpart JJJJJJ due to a switch to 100 percent natural gas, you must provide notice of the date upon which you switched fuels within 30 days of the change. The notification must identify:
(1) The name of the owner or operator of the affected source, the location of the source, the boiler(s) that have switched fuels or were modified, and the date of the notice.
(2) The date upon which the fuel switch or modification occurred.
Section 63.11226 is amended by revising the section, including the section heading, to read as follows:
§63.11226 Affirmative Defense for Violation of Emission Standards During Malfunction
In response to an action to enforce the standards set forth in §63.11201 you may assert an affirmative defense to a claim for civil penalties for violations of such standards that are caused by malfunction, as defined at §63.2. Appropriate penalties may be assessed; however, if you fail to meet your burden of proving all of the requirements in the affirmative defense, the affirmative defense shall not be available for claims for injunctive relief.
(a) To establish the affirmative defense in any action to enforce such a standard, you must timely meet the reporting requirements in paragraph (b) of this section, and must prove by a preponderance of evidence that:
(1) The violation:
(i) Was caused by a sudden, infrequent, and unavoidable failure of air pollution control equipment, process equipment, or a process to operate in a normal or usual manner; and
(ii) Could not have been prevented through careful planning, proper design or better operation and maintenance practices; and
(iii) Did not stem from any activity or event that could have been foreseen and avoided, or planned for; and
(iv) Was not part of a recurring pattern indicative of inadequate design, operation, or maintenance; and
(2) Repairs were made as expeditiously as possible when a violation occurred. Off-shift and overtime labor were used, to the extent practicable to make these repairs; and
(3) The frequency, amount, and duration of the violation (including any bypass) were minimized to the maximum extent practicable; and
(4) If the violation resulted from a bypass of control equipment or a process, then the bypass was unavoidable to prevent loss of life, personal injury, or severe property damage; and
(5) All possible steps were taken to minimize the impact of the violation on ambient air quality, the environment, and human health; and
(6) All emissions monitoring and control systems were kept in operation if at all possible, consistent with safety and good air pollution control practices; and
(7) All of the actions in response to the violations were documented by properly signed, contemporaneous operating logs; and
(8) At all times, the affected source was operated in a manner consistent with good practices for minimizing emissions; and
(9) A written root cause analysis has been prepared, the purpose of which is to determine, correct, and eliminate the primary causes of the malfunction and the violation resulting from the malfunction event at issue. The analysis shall also specify, using best monitoring methods and engineering judgment, the amount of excess emissions that were the result of the malfunction.
(b) Report. The owner or operator seeking to assert an affirmative defense shall submit a written report to the Administrator with all necessary supporting documentation, that it has met the requirements set forth in §63.11201 of this subpart. This affirmative defense report shall be included in the first periodic compliance, deviation report or excess emission report otherwise required after the initial occurrence of the violation of the relevant standard (which may be the end of any applicable averaging period). If such compliance, deviation report or excess emission report is due less than 45 days after the initial occurrence of the violation, the affirmative defense report may be included in the second compliance, deviation report or excess emission report due after the initial occurrence of the violation of the relevant standard.
Section 63.11236 is amended by revising paragraph (a) to read as follows:
§63.11236 Who implements and enforces this subpart?
(a) This subpart can be implemented and enforced by EPA or an administrator such as your state, local, or tribal agency. If the EPA Administrator has delegated authority to your state, local, or tribal agency, then that agency has the authority to implement and enforce this subpart. You should contact your EPA Regional Office to find out if implementation and enforcement of this subpart is delegated to your state, local, or tribal agency.
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Section 63.11237 is amended as follows:
a. By adding new definitions in alphabetical order for "10-day rolling average," "30-day rolling average," "Biodiesel," "Calendar year," "Daily block average," "Distillate oil," "Electric boiler," "Electric utility steam generating unit (EGU)," "Energy management program," "Load fraction," "Minimum scrubber pressure drop," "Minimum sorbent injection rate," "Minimum total secondary electric power," "Operating day," "Oxygen analyzer system," "Oxygen trim system," "Process heater," "Residential boiler," "Residual oil," "Seasonal boiler," "Shutdown," "Startup," "Solid fuel," "Temporary boiler," "Tune-up," "Vegetable oil," and "Wet scrubber."
b. By revising the definitions for "Annual heat input basis," "Bag leak detection system," "Biomass subcategory," "Boiler," "Boiler system," "Deviation," "Dry scrubber," "Energy assessment," "Energy use system," "Federally enforceable," "Gas-fired boiler," "Heat input," "Hot water heater," "Institutional boiler," "Minimum activated carbon injection rate," "Minimum scrubber liquid flow rate," "Natural gas," "Oil subcategory," "Period of natural gas curtailment or supply interruption," "Qualified Energy Assessor," and "Waste heat boiler."
c. By deleting the definitions for "Minimum PM scrubber pressure drop," "Minimum sorbent flow rate," "Minimum voltage or amperage."
§63.11237 What definitions apply to this subpart?
	10-day rolling average means the arithmetic mean of all valid hours of data from 10 successive operating days, except for periods of startup and shutdown and periods when the unit is not operating.
30-day rolling average means the arithmetic mean of all valid hours of data from 30 successive operating days, except for periods of startup and shutdown and periods when the unit is not operating.
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Annual heat input basis means the heat input for the 12 months preceding the compliance demonstration.
Bag leak detection system means a group of instruments that are capable of monitoring particulate matter loadings in the exhaust of a fabric filter (i.e., baghouse) in order to detect bag failures. A bag leak detection system includes, but is not limited to, an instrument that operates on electrodynamic, triboelectric, light scattering, light transmittance, or other principle to monitor relative particulate matter loadings.
Biodiesel means a mono-akyl ester derived from biomass and conforming to ASTM D6751 - 11b, Standard Specification for Biodiesel Fuel Blend Stock (B100) for Middle Distillate Fuels (incorporated by reference, see §63.14).
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Biomass subcategory includes any boiler that burns any biomass and is not in the coal subcategory.
Boiler means an enclosed device using controlled flame combustion in which water is heated to recover thermal energy in the form of steam and/or hot water. Controlled flame combustion refers to a steady-state, or near steady-state, process wherein fuel and/or oxidizer feed rates are controlled. A device combusting solid waste, as defined in §241.3, is not a boiler unless the device is exempt from the definition of a solid waste incineration unit as provided in section 129(g)(1) of the Clean Air Act. Waste heat boilers, process heaters, and autoclaves are excluded from this definition.
Boiler system means the boiler and associated components, such as, feedwater systems, combustion air systems, fuel systems (including burners), blowdown systems, combustion control systems, steam systems, and condensate return systems, directly connected to and serving the energy use systems.
Calendar year means the period between January 1 and December 31, inclusive, for a given year.
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Daily block average means the arithmetic mean of all valid emission concentrations or parameter levels recorded when a unit is operating measured over the 24-hour period from 12 am (midnight) to 12 am (midnight), except for periods of startup and shutdown or downtime.
Deviation (1) Means any instance in which an affected source subject to this subpart, or an owner or operator of such a source:
(i) Fails to meet any applicable requirement or obligation established by this subpart including, but not limited to, any emission limit, operating limit, or work practice standard; or
(ii) Fails to meet any term or condition that is adopted to implement an applicable requirement in this subpart and that is included in the operating permit for any affected source required to obtain such a permit.
(2) A deviation is not always a violation. The determination of whether a deviation constitutes a violation of the standard is up to the discretion of the entity responsible for enforcement of the standards.
Distillate oil means fuel oils that contain 0.05 weight percent nitrogen or less and comply with the specifications for fuel oil numbers 1 and 2, as defined by the American Society of Testing and Materials in ASTM D396 (incorporated by reference, see § 63.14) or diesel fuel oil numbers 1 and 2, as defined by the American Society for Testing and Materials in ASTM D975 (incorporated by reference, see §63.14).
Dry scrubber means an add-on air pollution control system that injects dry alkaline sorbent (dry injection) or sprays an alkaline sorbent (spray dryer) to react with and neutralize acid gas in the exhaust stream forming a dry powder material. Sorbent injection systems used as control devices in fluidized bed boilers and process heaters are included in this definition. A dry scrubber is a dry control system.
Electric boiler means a boiler in which electric heating serves as the source of heat. Electric boilers that burn gaseous or liquid fuel during periods of electrical power curtailment or failure are included in this definition.
Electric utility steam generating unit (EGU) means a fossil fuel-fired combustion unit of more than 25 megawatts that serves a generator that produces electricity for sale. A fossil fuel-fired unit that cogenerates steam and electricity and supplies more than one-third of its potential electric output capacity and more than 25 megawatts electrical output to any utility power distribution system for sale is considered an electric utility steam generating unit. To be "capable of combusting" fossil fuels, an EGU would need to have these fuels allowed in their operating permits and have the appropriate fuel handling facilities on-site or otherwise available (e.g., coal handling equipment, including coal storage area, belts and conveyers, pulverizers, etc.; oil storage facilities). In addition, fossil fuel-fired EGU means any EGU that fired fossil fuel for more than 10.0 percent of the average annual heat input in any 3 consecutive calendar years or for more than 15.0 percent of the annual heat input during any one calendar year after April 16, 2015.
Electrostatic precipitator (ESP) means an add-on air pollution control device used to capture particulate matter by charging the particles using an electrostatic field, collecting the particles using a grounded collecting surface, and transporting the particles into a hopper. An electrostatic precipitator is usually a dry control system.
Energy assessment means the following for the emission units covered by this subpart:
(1) The energy assessment for facilities with affected boilers using less than 0.3 trillion Btu per year (TBtu/year) heat input will be 8 on-site technical labor hours in length maximum, but may be longer at the discretion of the owner or operator of the affected source. The boiler system(s) and any on-site energy use system(s) accounting for at least 50 percent of the affected boiler(s) energy output will be evaluated to identify energy savings opportunities, within the limit of performing an 8-hour energy assessment.
(2) The energy assessment for facilities with affected boilers using 0.3 to 1.0 TBtu/year will be 24 on-site technical labor hours in length maximum, but may be longer at the discretion of the owner or operator of the affected source. The boiler system(s) and any on-site energy use system(s) accounting for at least 33 percent of the affected boiler(s) energy output will be evaluated to identify energy savings opportunities, within the limit of performing a 24-hour energy assessment.
(3) The energy assessment for facilities with affected boilers using greater than 1.0 TBtu/year will be up to 24 on-site technical labor hours in length for the first TBtu/year plus 8 on-site technical labor hours for every additional 1.0 TBtu/year not to exceed 160 on-site technical hours, but may be longer at the discretion of the owner or operator of the affected source. The boiler system(s) and any on-site energy use system(s) accounting for at least 20 percent of the affected boiler(s) energy output will be evaluated to identify energy savings opportunities.
(4) The on-site energy use system(s) serving as the basis for the percent of affected boiler(s) energy output in (1), (2), and (3) above may be segmented by production area or energy use area as most logical and applicable to the specific facility being assessed (e.g., product X manufacturing area; product Y drying area; Building Z).
Energy management program means a program according to the ENERGY STAR guideline for energy management, DOE Save Energy Now, or ISO 50001 compatible energy management systems (e.g., includes a set of practices and procedures designed to manage energy use that are demonstrated by the facility's energy policies, a facility energy manager and other staffing responsibilities, energy performance measurement and tracking methods, an energy saving goal, action plans, operating procedures, internal reporting requirements, and periodic review intervals used at the facility).
Energy use system includes the following systems located on the site of the affected boiler that use energy provided by the boiler: (i) process heating; compressed air systems; machine drive (motors, pumps, fans); process cooling; facility heating, ventilation, and air conditioning systems; hot water systems; building envelop; and lighting; or (ii) other systems that use steam or hot water provided by the boiler.
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Federally enforceable means all limitations and conditions that are enforceable by the EPA Administrator, including, but not limited to, the requirements of 40 CFR parts 60, 61, 63, and 65, requirements within any applicable state implementation plan, and any permit requirements established under 40 CFR 52.21 or under 40 CFR 51.18 and 40 CFR 51.24.
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Gas-fired boiler includes any boiler that burns gaseous fuels not combined with any solid fuels, burns liquid fuel only during periods of gas curtailment, gas supply interruption, startups, or periodic testing on liquid fuel. Periodic testing of liquid fuel shall not exceed a combined total of 48 hours during any calendar year.
Heat input means heat derived from combustion of fuel in a boiler and does not include the heat input from preheated combustion air, recirculated flue gases, returned condensate, or exhaust gases from other sources such as gas turbines, internal combustion engines, kilns, etc.
Hot water heater means a closed vessel with a capacity of no more than 120 U.S. gallons in which water is heated by combustion of gaseous, liquid, or biomass fuel and hot water is withdrawn for use external to the vessel. Hot water boilers (i.e., not generating steam) combusting gaseous, liquid, or biomass fuel with a heat input capacity of less than 1.6 million Btu per hour are included in this definition. The 120 U.S. gallon capacity threshold to be considered a hot water heater is independent of the 1.6 MMBtu/hr heat input capacity threshold for hot water boilers. Hot water heater also means a tankless unit that provides on demand hot water.
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Institutional boiler means a boiler used in institutional establishments such as, but not limited to, medical centers, nursing homes, research centers, institutions of higher education, elementary and secondary schools, libraries, religious establishments, and governmental buildings to provide electricity, steam, and/or hot water.
Liquid fuel includes, but is not limited to, distillate oil, residual oil, any form of liquid fuel derived from petroleum, used oil, liquid biofuels, biodiesel, and vegetable oil.
Load fraction means the actual heat input of a boiler divided by heat input during the performance test that established the minimum sorbent injection rate or minimum activated carbon injection rate, expressed as a fraction (e.g., for 50 percent load the load fraction is 0.5).
Minimum activated carbon injection rate means load fraction multiplied by the lowest 2-hour average activated carbon injection rate measured according to Table 6 to this subpart during the most recent performance stack test demonstrating compliance with the applicable emission limits.
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Minimum scrubber liquid flow rate means the lowest 1-hour average scrubber liquid flow rate (e.g., to the PM scrubber) measured according to Table 6 to this subpart during the most recent performance stack test demonstrating compliance with the applicable emission limit.
Minimum scrubber pressure drop means the lowest 1-hour average scrubber pressure drop measured according to Table 6 to this subpart during the most recent performance stack test demonstrating compliance with the applicable emission limit.
Minimum sorbent injection rate means load fraction multiplied by the lowest 2-hour average sorbent injection rate measured according to Table 6 to this subpart during the most recent performance stack test demonstrating compliance with the applicable emission limits.
Minimum total secondary electric power means the lowest hourly average total secondary electric power determined from the values of secondary voltage and secondary current to the electrostatic precipitator measured according to Table 6 to this subpart during the most recent performance stack test demonstrating compliance with the applicable emission limits.
Natural gas means:
(1) A naturally occurring mixture of hydrocarbon and nonhydrocarbon gases found in geologic formations beneath the earth's surface, of which the principal constituent is methane; or
(2) Liquefied petroleum gas, as defined by the American Society for Testing and Materials in ASTM D1835 (incorporated by reference, see §63.14).
(3) A mixture of hydrocarbons that maintains a gaseous state at ISO conditions. Additionally, natural gas must either be composed of at least 70 percent methane by volume or have a gross calorific value between 34 and 43 megajoules (MJ) per dry standard cubic meter (910 and 1,150 Btu per dry standard cubic foot).
(4) Propane or propane-derived synthetic natural gas. Propane means a colorless gas derived from petroleum and natural gas, with the molecular structure C3H8.
Oil subcategory includes any boiler that burns any liquid fuel and is not in either the biomass or coal subcategories. Gas-fired boilers that burn liquid fuel only during periods of gas curtailment, gas supply interruptions, startups, or for periodic testing are not included in this definition. Periodic testing on liquid fuel shall not exceed a combined total of 48 hours during any calendar year..
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Operating day means a 24-hour period between 12 midnight and the following midnight during which any fuel is combusted at any time in the boiler unit. It is not necessary for fuel to be combusted for the entire 24-hour period.
Oxygen analyzer system means all equipment required to determine the oxygen content of a gas stream and used to monitor oxygen in the boiler flue gas, boiler firebox, or other appropriate intermediate location. This definition includes oxygen trim systems. The source owner or operator must install, calibrate, maintain, and operate the oxygen analyzer system in accordance with the manufacturer's recommendations.
Oxygen trim system means a system of monitors that is used to maintain excess air at the desired level in a combustion device. A typical system consists of a flue gas oxygen and/or carbon monoxide monitor that automatically provides a feedback signal to the combustion air controller.
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Period of gas curtailment or supply interruption means a period of time during which the supply of gaseous fuel to an affected boiler is restricted for reasons beyond the control of the facility. The act of entering into a contractual agreement with a supplier of natural gas established for curtailment purposes does not constitute a reason that is under the control of a facility for the purposes of this definition. An increase in the cost or unit price of natural gas due to normal market fluctuations not during periods of supplier delivery restriction does not constitute a period of natural gas curtailment or supply interruption. On-site gaseous fuel system emergencies or equipment failures may qualify as periods of supply interruption when the emergency or failure is beyond the control of the facility.
Process heater means an enclosed device using controlled flame, and the unit's primary purpose is to transfer heat indirectly to a process material (liquid, gas, or solid) or to a heat transfer material (e.g., glycol or a mixture of glycol and water) for use in a process unit, instead of generating steam. Process heaters are devices in which the combustion gases do not come into direct contact with process materials. Process heaters include units that heat water/water mixtures for pool heating, sidewalk heating, cooling tower water heating, power washing, or oil heating.
Qualified energy assessor means a person or persons who have demonstrated capabilities to evaluate energy savings opportunities for steam generation, process heat, and major steam and process heat using systems, as applicable to the facility. Qualified energy assessors may be company employees or outside specialists.
Residential boiler means a boiler used in a dwelling containing four or fewer family units to provide heat and/or hot water and/or as part of a residential combined heat and power system. This definition includes boilers used primarily to provide heat and/or hot water for a dwelling containing four or fewer families located at an institutional facility (e.g., university campus, military base, church grounds) or commercial/industrial facility (e.g., farm).
Residual oil means crude oil, fuel oil numbers 1 and 2 that have a nitrogen content greater than 0.05 weight percent, and all fuel oil numbers 4, 5, and 6, as defined by the American Society of Testing and Materials in ASTM D396 - 10 (incorporated by reference, see §63.14(b)).
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Seasonal boiler means a boiler that undergoes a shutdown for a period of at least 7 consecutive months (or 210 consecutive days) each 12-month period due to seasonal market conditions, except for periodic testing. Periodic testing shall not exceed a combined total of 15 days during the 7-month shutdown. This definition only applies to boilers that would otherwise be included in the biomass subcategory or the oil subcategory.
Shutdown means the cessation of operation of a boiler for any purpose. Shutdown begins either when none of the steam or heat from the boiler is supplied for heating and/or producing electricity, or for any other purpose, or at the point of no fuel being fired in the boiler, whichever is earlier. Shutdown ends when there is both no steam or heat being supplied and no fuel being fired in the boiler.
Solid fossil fuel includes, but is not limited to, coal, coke, petroleum coke, and tire derived fuel.
Solid fuel means any solid fossil fuel or biomass or bio-based solid fuel.
Startup means either the first-ever firing of fuel in a boiler for the purpose of supplying steam or heat for heating and/or producing electricity, or for any other purpose, or the firing of fuel in a boiler after a shutdown event for any purpose. Startup ends when any of the steam or heat from the boiler is supplied for heating and/or producing electricity, or for any other purpose.
Temporary boiler means any gaseous or liquid fuel boiler that is designed to, and is capable of, being carried or moved from one location to another by means of, for example, wheels, skids, carrying handles, dollies, trailers, or platforms. A boiler is not a temporary boiler if any one of the following conditions exists:
(1) The equipment is attached to a foundation.
(2) The boiler or a replacement remains at a location within the facility and performs the same or similar function for more than 12 consecutive months, unless the regulatory agency approves an extension. An extension may be granted by the regulating agency upon petition by the owner or operator of a unit specifying the basis for such a request. Any temporary boiler that replaces a temporary boiler at a location within the facility and performs the same or similar function will be included in calculating the consecutive time period.
(3) The equipment is located at a seasonal facility and operates during the full annual operating period of the seasonal facility, remains at the facility for at least 2 years, and operates at that facility for at least 3 months each year.
(4) The equipment is moved from one location to another within the facility in an attempt to circumvent the residence time requirements of this definition.
Tune-up means adjustments made to a boiler in accordance with the procedures outlined in §63.11223(b).
Vegetable oil means oils extracted from vegetation.
Waste heat boiler means a device that recovers normally unused energy and converts it to usable heat. Waste heat boilers are also referred to as heat recovery steam generators. This definition includes both fired and unfired waste heat boilers.
Wet scrubber means any add-on air pollution control device that mixes an aqueous stream or slurry with the exhaust gases from a boiler to control emissions of particulate matter or to absorb and neutralize acid gases, such as hydrogen chloride. A wet scrubber creates an aqueous stream or slurry as a byproduct of the emissions control process.
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Tables 1, 2, 6 and 7 to subpart JJJJJJ are revised to read as follows:
Table 1 to Subpart JJJJJJ of Part 63  --  Emission Limits
As stated in § 63.11201, you must comply with the following applicable emission limits:
                   If your boiler is in this subcategory...
                        For the following pollutants...
You must achieve less than or equal to the following emission limits, except during periods of startup and shutdown ...
1.	New coal-fired boiler with heat input capacity of 30 MMBtu/hr or greater
a.	PM (Filterable)
3.0E-02 lb per MMBtu of heat input.

b.	Mercury
2.2E-05 lb per MMBtu of heat input.

c.	CO
420 ppm by volume on a dry basis corrected to 3 percent oxygen (3-run average or 10-day rolling average).
2.	New coal-fired boiler with heat input capacity of between 10 and 30 MMBtu/hr
a.	PM (Filterable)
4.2E-01 lb per MMBtu of heat input.

b.	Mercury

2.2E-05 lb per MMBtu of heat input.

c.	CO
420 ppm by volume on a dry basis corrected to 3 percent oxygen (3-run average or 10-day rolling average).
3.	New biomass-fired boiler with heat input capacity of 30 MMBtu/hr or greater
a.	PM (Filterable)
3.0E-02 lb per MMBtu of heat input.
4.	New biomass fired boiler with heat input capacity of between 10 and 30 MMBtu/hr
a.	PM (Filterable)
7.0E-02 lb per MMBtu of heat input.
5.	New oil-fired boiler with heat input capacity of 10 MMBtu/hr or greater
a.	PM (Filterable)
3.0E-02 lb per MMBtu of heat input.
6.	Existing coal
(units with heat input capacity of 10 MMBtu/hr or greater)
a.		Mercury
2.2E-05 lb per MMBtu of heat input.

b.	CO
420 ppm by volume on a dry basis corrected to 3 percent oxygen.

Table 2 to Subpart JJJJJJ of Part 63  --  Work Practice Standards, Emission Reduction Measures, and Management Practices
As stated in § 63.11201, you must comply with the following applicable work practice standards, emission reduction measures, and management practices:
                   If your boiler is in this subcategory...
                        You must meet the following...
1. Existing or new coal, new biomass, and new oil (units with heat input capacity of 10 MMBtu/hr or greater)
Minimize the boiler's startup and shutdown periods following the manufacturer's recommended procedures. If manufacturer's recommended procedures are not available, you must follow recommended procedures for a unit of similar design for which manufacturer's recommended procedures are available.
2. Existing coal (units with heat input capacity of less than 10 MMBtu/hr)
Conduct an initial tune-up as specified in §63.11214, and conduct a tune-up of the boiler biennially as specified in §63.11223.
3. New coal (units with heat input capacity of less than 10 MMBtu/hr)
Conduct a tune-up of the boiler biennially as specified in §63.11223.

4. Existing oil-fired boilers with heat input capacity greater than 5 MMBtu/hr, and all existing biomass-fired boilers
Conduct an initial tune-up as specified in §63.11214, and conduct a tune-up of the boiler biennially as specified in §63.11223.

5. New oil-fired boilers with heat input capacity greater than 5 MMBtu/hr, and all new biomass-fired boilers
Conduct a tune-up of the boiler biennially as specified in §63.11223.

6. Existing seasonal boilers
Conduct an initial tune-up as specified in §63.11214, and conduct a tune-up of the boiler every 5 years as specified in §63.11223.

7. New seasonal boilers
Conduct a tune-up of the boiler every 5 years as specified in §63.11223.

8. Existing oil-fired boiler with heat input capacity of equal to or less than 5 MMBtu/hr
Conduct an initial tune-up as specified in §63.11214, and conduct a tune-up of the boiler every 5 years as specified in §63.11223.
9. New oil-fired boiler with heat input capacity of equal to or less than 5 MMBtu/hr
Conduct a tune-up of the boiler every 5 years as specified in §63.11223.
10. Existing or new boilers with an oxygen trim system that maintains an optimum air-to-fuel ratio
Conduct a tune-up of the boiler every 5 years as specified in §63.11223.
11. Existing coal, biomass, or oil (units with heat input capacity of 10 MMBtu/hr and greater)
Must have a one-time energy assessment performed by a qualified energy assessor or must operate under an energy management program developed according to the ENERGY STAR guideline for energy management, DOE Save Energy Now, or ISO 50001 compatible energy management systems, that includes the affected units. An energy assessment completed on or after January 1, 2008, that meets or is amended to meet the energy assessment requirements in this table satisfies the energy assessment requirement. Energy assessor approval and qualification requirements are waived in instances where past or amended energy assessments are used to meet the energy assessment requirements. The energy assessment must include:

(1) A visual inspection of the boiler system.
(2) An evaluation of operating characteristics of the affected boiler systems, specifications of energy use systems, operating and maintenance procedures, and unusual operating constraints,
(3) An inventory of major energy use systems consuming energy from affected boiler(s) and which are under control of the boiler owner or operator,
(4) A review of available architectural and engineering plans, facility operation and maintenance procedures and logs, and fuel usage,
(5) A list of major energy conservation measures that are within the facility's control,
(6) A list of the energy savings potential of the energy conservation measures identified, and
(7) A comprehensive report detailing the ways to improve efficiency, the cost of specific improvements, benefits, and the time frame for recouping those investments.

Table 3 to Subpart JJJJJJ of Part 63  --  Operating Limits for Boilers with Emission Limits
As stated in §63.11201, you must comply with the applicable operating limits:
If you demonstrate compliance with applicable emission limits using...
You must meet these operating limits except during periods of startup and shutdown...
1.	Fabric filter control
a.	Maintain opacity to less than or equal to 10 percent opacity (daily block average); OR

b.	Install and operate a bag leak detection system according to §63.11224 and operate the fabric filter such that the bag leak detection system alarm does not sound more than 5 percent of the operating time during each 6-month period.
2.	Electrostatic precipitator control
a. Maintain opacity to less than or equal to 10 percent opacity (daily block average); OR
b. Maintain the 30-day rolling average secondary electric power input of the electrostatic precipitator at or above the minimum secondary electric power measured during the most recent performance test demonstrating compliance with the particulate matter emission limitations.
3. Wet PM scrubber control
Maintain the 30-day rolling average pressure drop at or above the minimum scrubber pressure drop across the wet scrubber and the 30-day rolling average liquid flow-rate at or above the minimum scrubber liquid flow rate measured during the most recent performance test demonstrating compliance with the PM emission limitation.
4.	Dry sorbent or activated carbon injection control
Maintain the 30-day rolling average sorbent or activated carbon injection rate at or above the minimum sorbent injection rate or minimum activated carbon injection rate measured during the most recent performance test demonstrating compliance with the mercury emissions limitation. When your boiler operates at lower loads, multiply your sorbent or activated carbon injection rate by the load fraction (e.g., actual heat input divided by the heat input during performance stack test, for 50 percent load, multiply the injection rate operating limit by 0.5).
5. Any other add-on air pollution control type.
This option is for boilers that operate dry control systems. Boilers must maintain opacity to less than or equal to 10 percent opacity (daily block average).
6. Fuel analysis
Maintain the fuel type or fuel mixture (annual average) such that the mercury emission rates calculated according to §63.11211(c) are less than the applicable emission limits for mercury.
7. Performance stack testing
For boilers that demonstrate compliance with a performance stack test, maintain the operating load of each unit such that is does not exceed 110 percent of the average operating load recorded during the most recent performance stack test.
8. Oxygen analyzer system
For boilers subject to a CO emission limit that demonstrate compliance with an oxygen analyzer system as specified in §63.11224(a), maintain the 30-day rolling average oxygen level at or above the minimum oxygen level measured during the most recent CO performance stack test.

*	*	*	*	*

Table 6 to Subpart JJJJJJ of Part 63  --  Establishing Operating Limits
As stated in §63.11211, you must comply with the following requirements for establishing operating limits:
                 If you have an applicable emission limit for
                                     . . .
                    And your operating limits are based on
                                     . . .
                                  You must...
                                  Using . . .
                    According to the following requirements
1. PM or mercury
a. Wet scrubber operating parameters
i. Establish a site-specific minimum scrubber pressure drop and minimum scrubber liquid flow rate operating limits according to §63.11211(b)
(1) Data from the pressure drop and liquid flow rate monitors and the PM or mercury performance stack tests
(a) You must collect pressure drop and liquid flow rate data every 15 minutes during the entire period of the performance stack tests;

(b) Determine the average pressure drop and liquid flow rate for each individual test run in the three-run performance stack test by computing the average of all the 15-minute readings taken during each test run.

b. Electrostatic precipitator operating parameters
i. Establish a site-specific minimum secondary electric power operating limit according to §63.11211(b)
(1) Data from the secondary electric power monitors and the PM or mercury performance stack tests
(a) You must collect secondary electric power input data every 15 minutes during the entire period of the performance stack tests;

(b) Determine the average secondary electric power input for each individual test run in the three-run performance stack test by computing the average of all the 15-minute readings taken during each test run.
2. Mercury
a. Dry sorbent or activated carbon injection rate operating parameters
i. Establish a site-specific minimum sorbent or activated carbon injection rate operating limit according to §63.11211(b)
(1) Data from the sorbent or activated carbon injection rate monitors and the mercury performance stack tests
(a) You must collect sorbent or activated carbon injection rate data every 15 minutes during the entire period of the performance stack tests;

(b) Determine the average sorbent or activated carbon injection rate for each individual test run in the three-run performance stack test by computing the average of all the 15-minute readings taken during each test run.

(c) When your unit operates at lower loads, multiply your sorbent or activated carbon injection rate by the load fraction (e.g., actual heat input divided by heat input during performance stack test, for 50 percent load, multiply the injection rate operating limit by 0.5) to determine the required injection rate.
3. CO
a. Oxygen
i. Establish a unit-specific limit for minimum oxygen level.
(1) Data from the oxygen analyzer system specified in §63.11224(a).
(a) You must collect oxygen data every 15 minutes during the entire period of the performance stack tests;

(b) Determine the average hourly oxygen concentration
for each individual test run in the three-run performance stack test by computing the average of all the 15-minute readings taken during each test run.
4. Any pollutant for which
compliance is demonstrated
by a performance
stack test.
a. Boiler operating load.
i. Establish a unit-specific
limit for maximum operating
load according to
§63.11212(c).
(1) Data from the operating
load monitors (fuel feed monitors or
steam generation monitors).
(a) You must collect operating
load data (fuel feed rate or steam generation
data) every 15
minutes during the entire
period of the performance test.
(b) Determine the average
operating load by computing
the hourly averages using all of the 15-minute readings taken during each performance test.
(c) Determine the average
of the three test run
averages during the performance
test, and multiply
this by 1.1 (110
percent) as your operating limit.

Table 7 to Subpart JJJJJJ of Part 63  --  Demonstrating Continuous Compliance
As stated in §63.11222, you must show continuous compliance with the emission limitations for each boiler according to the following:
             If you must meet the following operating limits . . .
              You must demonstrate continuous compliance by . . .
1. Opacity
a. Collecting the opacity monitoring system data according to §63.11224(e) and §63.11221; and

b. Reducing the opacity monitoring data to 6-minute averages; and

c. Maintaining opacity to less than or equal to 10 percent (daily block average).
2. Fabric Filter Bag Leak Detection Operation
Installing and operating a bag leak detection system according to §63.11224(f) and operating the fabric filter such that the requirements in §63.11222(a)(4) are met.
3. Wet Scrubber Pressure Drop and Liquid Flow Rate
a. Collecting the pressure drop and liquid flow rate monitoring system data according to §§63.11224 and 63.11221; and

b. Reducing the data to 30-day rolling averages; and

c. Maintaining the 30-day rolling average pressure drop and liquid flow rate at or above the operating limits established during the performance test according to §63.11211.
4. Dry Scrubber Sorbent or Activated Carbon Injection Rate
a. Collecting the sorbent or activated carbon injection rate monitoring system data for the dry scrubber according to §§63.11224 and 63.11221; and

b. Reducing the data to 30-day rolling averages; and

c. Maintaining the 30-day rolling average sorbent or activated carbon injection rate at or above the minimum sorbent or activated carbon injection rate as defined in §63.11237.
5. Electrostatic Precipitator Total Secondary Electric Power Input
a. Collecting the total secondary electric power input monitoring system data for the electrostatic precipitator according to §§63.11224 and 63.11221; and

b. Reducing the data to 30-day rolling averages; and

c. Maintaining the 30-day rolling average total secondary electric power input at or above the operating limits established during the performance test according to §63.11211.
6. Fuel Pollutant Content
a. Only burning the fuel types and fuel mixtures used to demonstrate compliance with the applicable emission limit according to §63.11213 as applicable; and

b. Keeping monthly records of fuel use according to §63.11222.
7. Oxygen content
a. Continuously monitor the oxygen content of flue gas according to §63.11224.

b. Reducing the data to 30-day rolling averages; and

c. Maintain the 30-day rolling average oxygen content at or above the operating limit established during the most recent CO performance test.
8. CO emissions
a. Continuously monitor the CO concentration in the combustion exhaust according to §63.11224(a).

b. Correcting the data to 3 percent oxygen, and reducing the data to one-hour and daily block averages;

c. Reducing the data from the daily averages to 10-day rolling averages;

d. Maintaining the 10-day rolling average CO concentration at or below the applicable emission limit in Tables 1 of this subpart.
9. Boiler operating load
a. Collecting operating load data (fuel feed rate or steam generation data) every 15 minutes.
b. Reducing the data to 30-day rolling averages; and
c. Maintaining the 30-day rolling average at or below the operating limit established during the performance test according to §63.11212(c).


[Federal Register Volume 79, Number 226 (Monday, November 24, 2014)]
[Notices]
[Page 69937]
[FR Doc No: 2014-27704]

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SECURITIES AND EXCHANGE COMMISSION

[Release No. 34-73626; File No. SR-CME-2014-31]

Self-Regulatory Organizations; Chicago Mercantile Exchange Inc.;
Notice of Withdrawal of Proposed Rule Change Related to Clearing of
Certain iTraxx Europe Index Untranched CDS Contracts on Indices
Administered by Markit

November 18, 2014.
    On August 11, 2014, Chicago Mercantile Exchange Inc. (``CME'')
filed with the Securities and Exchange Commission (``Commission''),
pursuant to Section 19(b)(1) of the Securities Exchange Act of 1934 \1\
and Rule 19b-4 thereunder,\2\ a proposed rule change (SR-CME-2014-31)
seeking to enable CME to offer clearing of certain iTraxx Europe index
untranched CDS contracts on indices administered by Markit (``iTraxx
Contracts''). Specifically, the proposed rule change would update CME's
CDS Product Rules to provide for the clearing of the iTraxx Contracts.
Notice of the proposed rule change was published in the Federal
Register on August 18, 2014.\3\ Notice of Amendment No. 2 to the
proposed rule change was published in the Federal Register on October
1, 2014.\4\ The Commission did not receive comments on the proposal.
---------------------------------------------------------------------------

    \1\ 15 U.S.C. 78s(b)(1).
    \2\ 17 CFR 240.19b-4.
    \3\ Securities Exchange Act Release No. 34-72833 (August 13,
2014), 79 FR 48797 (August 18, 2014) (SR-CME-2014-31).
    \4\ Securities Exchange Act Release No. 34-73275 (October 1,
2014), 79 FR 60563 (October 7, 2014) (SR-CME-2014-31). On August 18,
2014, CME filed Amendment No. 1 to the proposed rule change. CME
withdrew Amendment No. 1 on August 29, 2014.
---------------------------------------------------------------------------

    On October 2, 2014, the Commission extended the time period in
which to either approve the proposed rule change, disapprove the
proposed rule change, or institute proceedings to determine whether to
disapprove the proposed rule change to November 16, 2014.\5\ On
November 14, 2014, CME withdrew the proposed rule change (SR-CME-2014-
31).
---------------------------------------------------------------------------

    \5\ Securities Exchange Act Release No. 34-73290 (October 2,
2014), 79 FR 60873 (October 8, 2014) (SR-CME-2014-31).

    For the Commission, by the Division of Trading and Markets,
pursuant to delegated authority.\6\
---------------------------------------------------------------------------

    \6\ 17 CFR 200.30-3(a)(12).
---------------------------------------------------------------------------

Kevin M. O'Neill,
Deputy Secretary.
[FR Doc. 2014-27704 Filed 11-21-14; 8:45 am]
BILLING CODE 8011-01-P


[Federal Register Volume 76, Number 110 (Wednesday, June 8, 2011)]
[Notices]
[Pages 33378-33379]
[FR Doc No: 2011-14035]

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

SECURITIES AND EXCHANGE COMMISSION

[Release No. 34-64584; File No. SR-Phlx-2011-69]

Self-Regulatory Organizations; Notice of Filing and Immediate
Effectiveness of Proposed Rule Change by NASDAQ OMX PHLX LLC To Conform
Exchange Rules

June 2, 2011.
    Pursuant to Section 19(b)(1) of the Securities Exchange Act of 1934
(``Act''),\1\ and Rule 19b-4 thereunder,\2\ notice is hereby given that
on May 25, 2011, NASDAQ OMX PHLX LLC (``Phlx'' or ``Exchange'') filed
with the Securities and Exchange Commission (``Commission'') the
proposed rule change as described in Items I, II, and III below, which
Items have been prepared by the Exchange. The Commission is publishing
this notice to solicit comments on the proposed rule change from
interested persons.
---------------------------------------------------------------------------

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

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

    The Exchange proposes to amend its Fee Schedule and Exchange Rules
99, 274, 279, 501, 507, 510, 640, 722, 985, 1033, 1092, 1001A, 1047A,
3201, 3211, 3228, 3312, 3404 and 3405 to conform the text of the Fee
Schedule and Rules to a rule change that was recently approved by the
Commission.\3\
---------------------------------------------------------------------------

    \3\ See Securities Exchange Act Release No. 64338 (April 25,
2011), 76 FR 12180 (March 4, 2011) (SR-Phlx-2011-13).
---------------------------------------------------------------------------

    The text of the proposed rule change is available on the Exchange's
Web site at http://nasdaqtrader.com/micro.aspx?id=PHLXfilings, at the
principal office of the Exchange, and at the Commission's Public
Reference Room.

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

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

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

1. Purpose
    The purpose of the proposed rule change is to conform the
Exchange's Fee Schedule and/or text of various Rules, as applicable, to
utilize language consistently throughout the Rulebook. The Exchange
recently filed a rule change, to among other things, change the name of
the Exchange's Board from a ``Board of Governors'' to a ``Board of
Directors'', eliminate references to foreign currency option
participations, and capitalize all uses of the word ``rule'' where that
word referred to an Exchange Rule.\4\
---------------------------------------------------------------------------

    \4\ Id.
---------------------------------------------------------------------------

    The Exchange proposes to amend the Fee Schedule and/or text of
various Rules, as applicable, to change references to a Board of
Governors to a Board of Directors and remove all references to foreign
currency options participations and participants. In addition, the
Exchange proposes to amend the Routing Fees in the Fee Schedule to
reorder the Routing Fees, specifically to move C2 after CBOE for ease
of reference.
    Additionally, the Exchange proposes to amend Rules 99, 274, 279,
501, 507, 510, 640, 722, 985, 1033, 1092, 1001A, 1047A, 3201, 3211,
3228, 3312, 3404 and 3405 to capitalize all uses of the word ``rule''
where that word referred to an Exchange Rule. The Exchange
inadvertently did not amend the Rule references in the prior filing.\5\
---------------------------------------------------------------------------

    \5\ Id.
---------------------------------------------------------------------------

2. Statutory Basis
    The Exchange believes that its proposal is consistent with Section
6(b) of the Act \6\ in general, and furthers the objectives of Section
6(b)(5) of the Act \7\ in particular, in that it is designed to promote
just and equitable principles of trade, to remove impediments to and
perfect the mechanism of a free and open market and a national market
system, and, in general to protect investors and the public interest,
by conforming the language in the Exchange's Fee Schedule and Rules so
that it is consistent throughout. The Exchange believes that these
amendments will clarify the Exchange's Rules (including the Fee
Schedule) to the benefit of the membership. The Exchange believes that
making the rules consistent will eliminate confusion with respect to
the various references it is amending.
---------------------------------------------------------------------------

    \6\ 15 U.S.C. 78f(b).
    \7\ 15 U.S.C. 78f(b)(5).
---------------------------------------------------------------------------

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

    The Exchange does not believe that the proposed rule change will
impose any burden on competition not necessary or appropriate in
furtherance of the purposes of the Act.

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

    No written comments were either solicited or received.

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

    Pursuant to Section 19(b)(3)(A) of the Act \8\ and Rule 19b-4(f)(1)
\9\ thereunder, the Exchange has designated this proposal as one that
constitutes a stated policy, practice or interpretation with respect to
the meaning, administration, or enforcement of an existing rule of the
SRO, and therefore has become effective.
---------------------------------------------------------------------------

    \8\ 15 U.S.C. 78s(b)(3)(A).
    \9\ 17 CFR 240.19b-4(f)(1).
---------------------------------------------------------------------------

    At any time within 60 days of the filing of the proposed rule
change, the Commission summarily may temporarily suspend such rule
change if it appears to the Commission that such action is necessary or
appropriate in the public interest, for the protection of investors, or
otherwise in furtherance of the purposes of the Act. If the Commission
takes such action, the Commission shall institute proceedings to
determine whether the proposed rule should be approved or disapproved.

IV. Solicitation of Comments

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

Electronic Comments

     Use the Commission's Internet comment form (http://www.sec.gov/rules/sro.shtml); or

     Send an e-mail to<EMAIL_ADDRESS>Please include
File Number SR-Phlx-2011-69 on the subject line.

Paper Comments

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

All submissions should refer to File Number SR-Phlx-2011-69. This file
number should be included on the subject line if e-mail is used. To
help the Commission process and review your comments more efficiently,
please use only one method. The Commission will post all comments on
the Commission's Internet Web site (http://www.sec.gov/rules/sro.shtml). Copies of the submission, all subsequent amendments, all
written statements with respect to the proposed rule change that are
filed with the Commission, and all written communications relating to
the proposed rule change between the Commission and any person, other
than those that may be withheld from the public in accordance with the
provisions of 5 U.S.C. 552, will be available for Web site viewing and
printing in the Commission's Public Reference Room, 100 F Street, NE.,
Washington, DC 20549, on official business days between the hours of 10
a.m. and 3 p.m. Copies of the filing also will be available for
inspection and copying at the principal office of the Exchange. All
comments received will be posted without change; the Commission does
not edit personal identifying information from submissions. You should
submit only information that you wish to make available publicly.
    All submissions should refer to File Number SR-Phlx-2011-69 and
should be submitted on or before June 29, 2011.

    For the Commission, by the Division of Trading and Markets,
pursuant to delegated authority.\10\
---------------------------------------------------------------------------

    \10\ 17 CFR 200.30-3(a)(12).
---------------------------------------------------------------------------

Cathy H. Ahn,
Deputy Secretary.
[FR Doc. 2011-14035 Filed 6-7-11; 8:45 am]
BILLING CODE 8011-01-P


[Federal Register Volume 86, Number 31 (Thursday, February 18, 2021)]
[Notices]
[Pages 10118-10119]
[FR Doc No: 2021-03242]

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

DEPARTMENT OF HOMELAND SECURITY

Coast Guard

[Docket No. USCG-2021-0046]

Information Collection Request to Office of Management and
Budget; OMB Control Number: 1625-0061

AGENCY: Coast Guard, DHS.

ACTION: Sixty-day notice requesting comments.

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

SUMMARY: In compliance with the Paperwork Reduction Act of 1995, the
U.S. Coast Guard intends to submit an Information Collection Request
(ICR) to the Office of Management and Budget (OMB), Office of
Information and Regulatory Affairs (OIRA), requesting an extension of
its approval for the following collection of information: 1625-0061,
Commercial Fishing Industry Vessel Safety Regulations; without change.
Our ICR describes the information we seek to collect from the public.
Before submitting this ICR to OIRA, the Coast Guard is inviting
comments as described below.

DATES: Comments must reach the Coast Guard on or before April 19, 2021.

ADDRESSES: You may submit comments identified by Coast Guard docket
number [USCG-2021-0046] to the Coast Guard using the Federal
eRulemaking Portal at https://www.regulations.gov. See the ``Public
participation and request for comments'' portion of the SUPPLEMENTARY
INFORMATION section for further instructions on submitting comments.
    A copy of the ICR is available through the docket on the internet
at https://www.regulations.gov. Additionally, copies are available
from: COMMANDANT (CG-6P), ATTN: PAPERWORK REDUCTION ACT MANAGER, U.S.
COAST GUARD, 2703 MARTIN LUTHER KING JR. AVE. SE, STOP 7710,
WASHINGTON, DC 20593-7710.

FOR FURTHER INFORMATION CONTACT: A.L. Craig, Office of Privacy
Management, telephone<PHONE_NUMBER>, or fax<PHONE_NUMBER>, for questions
on these documents.

SUPPLEMENTARY INFORMATION:

Public Participation and Request for Comments

    This notice relies on the authority of the Paperwork Reduction Act
of 1995; 44 U.S.C. chapter 35, as amended. An ICR is an application to
OIRA seeking the approval, extension, or renewal of a Coast Guard
collection of information (Collection). The ICR contains

information describing the Collection's purpose, the Collection's
likely burden on the affected public, an explanation of the necessity
of the Collection, and other important information describing the
Collection. There is one ICR for each Collection.
    The Coast Guard invites comments on whether this ICR should be
granted based on the Collection being necessary for the proper
performance of Departmental functions. In particular, the Coast Guard
would appreciate comments addressing: (1) The practical utility of the
Collection; (2) the accuracy of the estimated burden of the Collection;
(3) ways to enhance the quality, utility, and clarity of information
subject to the Collection; and (4) ways to minimize the burden of the
Collection on respondents, including the use of automated collection
techniques or other forms of information technology.
    In response to your comments, we may revise this ICR or decide not
to seek an extension of approval for the Collection. We will consider
all comments and material received during the comment period.
    We encourage you to respond to this request by submitting comments
and related materials. Comments must contain the OMB Control Number of
the ICR and the docket number of this request, [USCG-2021-0046], and
must be received by April 19, 2021.

Submitting Comments

    We encourage you to submit comments through the Federal eRulemaking
Portal at https://www.regulations.gov. If your material cannot be
submitted using https://www.regulations.gov, contact the person in the
FOR FURTHER INFORMATION CONTACT section of this document for alternate
instructions. Documents mentioned in this notice, and all public
comments, are in our online docket at https://www.regulations.gov and
can be viewed by following that website's instructions. Additionally,
if you go to the online docket and sign up for email alerts, you will
be notified when comments are posted.
    We accept anonymous comments. All comments received will be posted
without change to https://www.regulations.gov and will include any
personal information you have provided. For more about privacy and
submissions in response to this document, see DHS's eRulemaking System
of Records notice (85 FR 14226, March 11, 2020).

Information Collection Request

    Title: Commercial Fishing Industry Vessel Safety Regulations.
    OMB Control Number: 1625-0061.
    Summary: This information collection is intended to improve safety
on board vessels in the commercial fishing industry. The requirements
apply to those vessels and to seamen on them.
    Need: Under the authority of 46 U.S.C. 6104, the U.S. Coast Guard
has promulgated regulations in 46 CFR part 28 to reduce fatalities and
accidents in the commercial fishing industry. The rules allowing the
collection also provide means of verifying compliance and enhancing
safe operation of fishing vessels.
    Forms: None.
    Respondents: Owners, agents, individuals-in-charge of commercial
fishing vessels, and insurance underwriters.
    Frequency: On occasion.
    Hour Burden Estimate: The estimated burden remains 4,832 hours a
year.
    Authority: The Paperwork Reduction Act of 1995; 44 U.S.C. chapter
35, as amended.

    Dated: February 11, 2021.
Kathleen Claffie,
Chief, Office of Privacy Management, U.S. Coast Guard.
[FR Doc. 2021-03242 Filed 2-17-21; 8:45 am]
BILLING CODE 9110-04-P


[Federal Register Volume 79, Number 143 (Friday, July 25, 2014)]
[Rules and Regulations]
[Pages 43266-43267]
[FR Doc No: 2014-17663]

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

DEPARTMENT OF TRANSPORTATION

Pipeline and Hazardous Materials Safety Administration

49 CFR Part 173

Shippers--General Requirements for Shipments and Packagings

CFR Correction

    In Title 49 of the Code of Federal Regulations, Parts 100 to 177,
revised as of October 1, 2013, on page 527, in Sec.  173.62, in
paragraph (c)(5), at the end of the Table of Packing Methods, packing
instruction US 1 is reinstated to read as follows:

Sec.  173.62  Specific packaging requirements for explosives.

* * * * *
    (c) * * *
    (5) * * *

                        Table of Packing Methods
------------------------------------------------------------------------

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

                              * * * * * * *
US 1.........................  1. A jet perforating gun, charged, oil
                                well may be transported under the
                                following conditions:
                               a. Initiation devices carried on the same
                                motor vehicle or offshore supply vessel
                                must be segregated; each kind from every
                                other kind, and from any gun, tool or
                                other supplies, unless approved in
                                accordance with Sec.   173.56.
                                Segregated initiation devices must be
                                carried in a container having individual
                                pockets for each such device or in a
                                fully enclosed steel container lined
                                with a non-sparking material. No more
                                than two segregated initiation devices
                                per gun may be carried on the same motor
                                vehicle.
                               b. Each shaped charge affixed to the gun
                                may not contain more than 112 g (4
                                ounces) of explosives.
                               c. Each shaped charge if not completely
                                enclosed in glass or metal, must be
                                fully protected by a metal cover after
                                installation in the gun.
                               d. A jet perforating gun classed as 1.1D
                                or 1.4D may be transported by highway by
                                private or contract carriers engaged in
                                oil well operations.
                               (i) A motor vehicle transporting a gun
                                must have specially built racks or
                                carrying cases designed and constructed
                                so that the gun is securely held in
                                place during transportation and is not
                                subject to damage by contact, one to the
                                other or any other article or material
                                carried in the vehicle; and
                               (ii) The assembled gun packed on the
                                vehicle may not extend beyond the body
                                of the motor vehicle.
                               e. A jet perforating gun classed as 1.4D
                                may be transported by a private offshore
                                supply vessel only when the gun is
                                carried in a motor vehicle as specified
                                in paragraph (d) of this packing method
                                or on offshore well tool pallets
                                provided that:
                               (i) All conditions specified in
                                paragraphs (a), (b), and (c) of this
                                packing method are met;
                               (ii) The total explosive contents do not
                                exceed 90.8 kg (200 pounds) per tool
                                pallet;
                               (iii) Each cargo vessel compartment may
                                contain up to 90.8 kg (200 pounds) of
                                explosive content if the segregation
                                requirements in Sec.   176.83(b) of this
                                subchapter are met; and
                               (iv) When more than one vehicle or tool
                                pallet is stowed ``on deck'' a minimum
                                horizontal separation of 3 m (9.8 feet)
                                must be provided.
------------------------------------------------------------------------

[FR Doc. 2014-17663 Filed 7-24-14; 8:45 am]
BILLING CODE 1505-01-D


[Federal Register: December 1, 2008 (Volume 73, Number 231)]
[Rules and Regulations]
[Page 72737]
[DOCID:fr01de08-12]

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

DEPARTMENT OF TRANSPORTATION

Pipeline and Hazardous Materials Safety Administration

49 CFR Part 192

[Docket No. PHMSA-2005-23447]
RIN 2137-AE25

Pipeline Safety: Standards for Increasing the Maximum Allowable
Operating Pressure for Gas Transmission Pipelines

AGENCY: Pipeline and Hazardous Materials Safety Administration (PHMSA),
Department of Transportation (DOT)

ACTION: Stay of final rule.

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

SUMMARY: This Notice stays the effective date of a final rule published
October 17, 2008 (73 FR 62148). In accordance with the Congressional
Review Act, the final rule will be effective on December 22, 2008, 60
days after the final rule was transmitted to Congress .

DATES: Effective December 1, 2008 Sec. Sec.  192.112, 192.328,
192.611(a)(1); 192.611(a)(3)(i), (ii) and (iii); 192.619(a) and (d);
and 192.620 are stayed until December 22, 2008.

FOR FURTHER INFORMATION CONTACT: Alan Mayberry by phone at (202) 366-
5124, or by e-mail at<EMAIL_ADDRESS>
SUPPLEMENTARY INFORMATION:

I. Supplementary Background

    On October 17, 2008 PHMSA issued a final rule under Docket No.
PHMSA-2005-23447 amending the Pipeline Safety Regulations (PSR; 49 CFR
parts 190-199) to increase the regulatory maximum allowable operating
pressure (MAOP) for certain gas transmission pipelines. The October 17,
2008 Federal Resister notice announced that the final rule would be
effective November 17, 2008, thirty days after its publication. Because
the final rule is a major rule within the meaning of the Congressional
Review Act, however, its effective date must be delayed until 60 days
after publication in the Federal Register or transmission to Congress,
whichever is later. The final rule was transmitted to Congress on
October 22, 2008. Accordingly, we are staying its effective date until
December 22, 2008.

    Issued in Washington, DC, on November 24, 2008 under authority
delegated in 49 CFR part 1.
Carl T. Johnson,
Administrator.
[FR Doc. E8-28435 Filed 11-28-08; 8:45 am]

BILLING CODE 4910-60-P


[Federal Register Volume 81, Number 224 (Monday, November 21, 2016)]
[Notices]
[Pages 83244-83245]
[FR Doc No: 2016-27942]

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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2014-N-1050]

Report of the Center for Veterinary Medicine Working Group on the
Regulation of Animal Drug Availability Act Combination Drug Medicated
Feeds; Availability

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice of availability.

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SUMMARY: The Food and Drug Administration (FDA) is announcing the
availability of a report of a Center for Veterinary Medicine (CVM)
working group proposing possible changes to the current review
processes for new animal drug applications (NADAs) providing for the
use of multiple new animal drugs in combination drug medicated feeds.
This report was developed for the use of the CVM committee that will be
participating in discussions concerning the reauthorization of the
animal drug user fee program for 5 additional years through fiscal year
2023 (per the Animal Drug User Fee Amendments (ADUFA) IV).

ADDRESSES: For access to the docket to read background documents or the
electronic and written/paper comments received, go to https://www.regulations.gov and insert the docket number, found in brackets in
the heading of this document, into the ``Search'' box and follow the
prompts and/or go to the Division of Dockets Management, 5630 Fishers
Lane, rm. 1061, Rockville, MD 20852.

    Submit written requests for single copies of the report to the
Policy and Regulations Staff (HFV-6), Center for Veterinary Medicine,
Food and Drug Administration, 7519 Standish Pl., Rockville, MD 20855.
Send one self-addressed adhesive label to assist that office in
processing your requests. See the SUPPLEMENTARY INFORMATION section for
electronic access to the document.

FOR FURTHER INFORMATION CONTACT: Linda M. Wilmot, Center for Veterinary
Medicine (HFV-120), Food and Drug Administration, 7500 Standish Pl.,
Rockville, MD 20855,<PHONE_NUMBER><EMAIL_ADDRESS>
SUPPLEMENTARY INFORMATION: In the Federal Register of September 9, 2014
(79 FR 53431), CVM announced that it was beginning to explore possible
changes to the current review processes for NADAs for the use of
multiple new animal drugs in combination drug medicated feeds. In the
same Federal Register notice, FDA announced the opening of a docket to
receive input from the public on this issue. This effort is consistent
with the stated performance goal in the Animal Drug User Fee Amendments
of 2013 (ADUFA III) goals letter.
    In the Federal Register of April 29, 2016 (81 FR 25677), FDA
published a notice of availability of a draft CVM report, giving
interested persons until July 29, 2016, to comment. Those comments were
considered as the CVM working group report was finalized without
substantive changes. This report was developed for the discussions with
the regulated industry for reauthorization of ADUFA.
    Persons with access to the Internet may obtain this document on the
CVM ADUFA Meetings Web page: http://www.fda.gov/ForIndustry/UserFees/AnimalDrugUserFeeActADUFA/ucm042891.htm.

    Dated: November 15, 2016.
Leslie Kux,
Associate Commissioner for Policy.
[FR Doc. 2016-27942 Filed 11-18-16; 8:45 am]
 BILLING CODE 4164-01-P


[Federal Register Volume 76, Number 210 (Monday, October 31, 2011)]
[Notices]
[Page 67233]
[FR Doc No: 2011-28294]

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SECURITIES AND EXCHANGE COMMISSION

Sunshine Act Meeting

    Notice is hereby given, pursuant to the provisions of the
Government in the Sunshine Act, Public Law 94-409, that the Securities
and Exchange Commission will hold a Closed Meeting on Thursday,
November 3, 2011 at 2 p.m.
    Commissioners, Counsel to the Commissioners, the Secretary to the
Commission, and recording secretaries will attend the Closed Meeting.
Certain staff members who have an interest in the matters also may be
present.
    The General Counsel of the Commission, or his designee, has
certified that, in his opinion, one or more of the exemptions set forth
in 5 U.S.C. 552b(c)(3), (5), (7), 9(B) and (10) and 17 CFR
200.402(a)(3), (5), (7), 9(ii) and (10) permit consideration of the
scheduled matters at the Closed Meeting.
    Commissioner Aguilar, as duty officer, voted to consider the items
listed for the Closed Meeting in a closed session.
    The subject matter of the Closed Meeting scheduled for Thursday,
November 3, 2011 will be:

Institution and settlement of injunctive actions;
Institution and settlement of administrative proceedings;
Other matters relating to enforcement proceedings; and
A post argument discussion.

    At times, changes in Commission priorities require alterations in
the scheduling of meeting items.
    For further information and to ascertain what, if any, matters have
been added, deleted or postponed, please contact: The Office of the
Secretary at<PHONE_NUMBER>.

    Dated: October 27, 2011.
Elizabeth M. Murphy,
Secretary.
[FR Doc. 2011-28294 Filed 10-27-11; 4:15 pm]
BILLING CODE 8011-01-P


[Federal Register: August 13, 2010 (Volume 75, Number 156)]
[Notices]
[Page 49502-49504]
[DOCID:fr13au10-73]

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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. 2010-N-0389]

Medical Device User Fee Act; Public Meeting; Request for Comments

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice of public meeting; request for comments.

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SUMMARY: The Food and Drug Administration (FDA) is announcing a public
meeting on the reauthorization of the medical device user fee program.
The current legislative authority for the medical device user fee
program expires in September 2012 and new legislation will be required
for FDA to continue collecting user fees for the medical device
program. The Federal Food, Drug, and Cosmetic Act (FD&C Act) requires
that before FDA begins negotiations with the regulated industry on
medical device user fee program reauthorization, we publish a notice in
the Federal Register requesting public input on the reauthorization,
hold a public meeting at which the public may present its views on the
reauthorization, provide a period of 30 days after the public meeting
to obtain written comments from the public suggesting changes, and
publish the comments on FDA's Web site. FDA invites public comment on
the medical device user fee program and suggestions regarding the
commitments FDA should propose for the next reauthorized program.

    Date and Time: The public meeting will be held on September 14,
2010, from 9 a.m. to 5 p.m.
    Location: FDA is currently in the process of determining the
meeting location, which will be in the Washington DC metropolitan area.
When the location has been determined, FDA plans to publish a notice in
the Federal Register that will provide the address of the meeting
location.
    Contact Person: James Swink, Center for Devices and Radiological
Health, Food and Drug Administration, 10903 New Hampshire Ave., Bldg.
66, rm. 1609, Silver Spring, MD 20993,<PHONE_NUMBER>, FAX:<PHONE_NUMBER>,
<EMAIL_ADDRESS>    Registration and Requests for Oral Presentations: If you wish to
attend and/or present at the meeting, please register by August 31,
2010. Please register at http://www.fda.gov/MedicalDevices/NewsEvents/
WorkshopsConferences/ucm218250.htm. Those without e-mail access may
register by contacting James Swink (see Contact Person). Please provide
complete contact information for each attendee, including name, title,
firm name, address, e-mail address, telephone and fax number.
Registrants wishing to make a presentation or provide public comments
should note that when registering. Registration is free and will be on
a first-come, first-served basis. Early registration is recommended
because seating is limited. FDA may limit the number of participants
from each organization, as well as the total number of participants,
based on space limitations to ensure representation of all stakeholder
interest groups. Registrants will receive confirmation once they have
been accepted. Onsite registration on the day of the meeting will be
based on space availability. We will try to accommodate all persons who
wish to make a presentation or public comments. The time allotted for
presentations may depend on the number of persons who wish to speak.
    If you need special accommodations due to a disability, please
contact James Swink at least 7 days in advance.
    Comments: Regardless of attendance at the public meeting,
interested persons may submit either electronic or written comments by
October 14, 2010. Submit electronic comments to http://
www.regulations.gov. Submit written comments to the Division of Dockets
Management (HFA-305), Food and Drug Administration, 5630 Fishers Lane,
rm. 1061, Rockville, MD 20852. It is only necessary to send one set of
comments. It is no longer necessary to send two copies of mailed
comments. Identify comments with the docket number found in brackets in
the heading of this document. Received comments may be seen in the
Division of Dockets Management between 9 a.m. and 4 p.m., Monday
through Friday.

SUPPLEMENTARY INFORMATION:

I. Background

    FDA is announcing its intention to hold a public meeting on the
reauthorization of the medical device user fee program. The authority
for such program expires in September 2012. Without new legislation,
user fees can no longer be collected by FDA to fund the medical device
review process. Section 738A(b)(2) of the FD&C Act (21 U.S.C. 379j-
1(b)(2)) requires that, before FDA begins negotiations with the
regulated industry on user fee reauthorization, we do the following:
(1) Publish a notice in the Federal Register requesting public input on
the reauthorization; (2) hold a public meeting at which the public may
present its views on the reauthorization, including specific
suggestions for changes to the goals referred to in section 738A(a)(1);
(3) provide a period of 30 days after the public meeting to obtain
written comments from the public suggesting changes to this part; and
(4) publish the comments on the Food and Drug Administration's Web
site. This notice, the public meeting, the 30 day comment period after
the meeting, and the posting of the comments on the FDA Web site will
satisfy these requirements. The purpose of the meeting is to hear
stakeholder views on medical device user fee reauthorization as we
consider the features to propose in the next medical device user fee
program. FDA is interested in responses to the following two general
questions and welcomes any other pertinent information stakeholders
would like to share:
    1. What is your assessment of the overall performance of the
medical device user fee program thus far?
    2. What aspects of the medical device user fee program should be
retained, changed, or discontinued to further strengthen and improve
the program?
    The following information is provided to help potential meeting
participants better understand the history and evolution of the medical
device user fee program and its current status.

II. What is the Medical Device User Fee Program? What Does It Do?

    In the years preceding enactment of Medical Device User Fee and
Modernization Act of 2002 (MDUFMA) (Public Law 107-250), FDA's medical
device program suffered a long-term, significant loss of resources that
undermined the program's capacity and performance. MDUFMA was enacted
``in order to provide the Food and Drug Administration (FDA) with the
resources necessary to better review medical devices, to enact needed
regulatory reforms so that medical device manufacturers can bring their
safe and effective devices to the American people at an earlier time,
and to ensure that reprocessed medical devices are as safe and
effective as original devices.''\1\ MDUFMA had a 5-year life and
contained two particularly important features which relate to
reauthorization:
---------------------------------------------------------------------------

    \1\ H.R. Rep. No. 107-728, at 21 (2002).
---------------------------------------------------------------------------

     User fees for the review of medical device premarket
applications, reports, supplements, and premarket notification
submissions provided additional resources to make FDA reviews more
timely, predictable, and transparent to applicants. MDUFMA fees and
mandated appropriations for the medical device program helped FDA
expand available expertise, modernized its information management
systems, provided new review options, and provided more guidance to
prospective applicants. The ultimate goal was to approve and clear safe
and effective medical devices more rapidly, benefiting applicants, the
health care community, and most importantly, patients.
     Negotiated performance goals for many types of premarket
reviews provided FDA with benchmarks for measuring review improvements.
These quantifiable goals became more demanding each year and include
FDA decision goals and cycle goals (cycle goals refer to FDA actions
prior to a final action on a submission). Under MDUFMA, FDA must also
have met several other commitments that do not have specific timeframes
or direct measures of performance, such as expanding the use of
meetings with industry, maintenance of current performance in review
areas where specific performance goals have not been identified, and
publication of additional guidance documents.
    Medical device user fees and increased appropriations were viewed
by FDA, Congress, and industry stakeholders as essential to support
high-quality, timely medical device reviews, and other activities
critical to the device review program.
    MDUFMA provided for fee discounts and waivers for small businesses.
Small businesses make up a large proportion of the medical device
industry, and these discounts and waivers helped reduce the financial
impact of the user

fees on this sector of the device industry, which plays an important
role in fostering innovation.
    The negotiated performance goals and commitments that do not have
specific timeframes or direct measures of performance set under MDUFMA
were comprehensive and demanding. By Fiscal Year (FY) 2007,
approximately 85 performance goals and commitments were in effect. FDA
provided periodic reports on its progress towards meeting these
performance goals and commitments to its stakeholders and Congress. FDA
also provided an annual financial report to Congress that helped to
ensure transparency and accountability of its use of the additional
resources provided by MDUFMA.
    In 2007, Congress reauthorized medical device user fees through FY
2012 under the Medical Device User Fee Amendments of 2007 (MDUFA)
(title II of the Food and Drug Administration Amendments Act of 2007
(FDAAA) (Public Law 110-85).
    Under MDUFA, the user fee program remained intact, with a few
significant modifications to the program. The user fee framework was
changed to provide a more reliable and stable funding stream.
Specifically, MDUFA included establishment registration as a new fee
type that provided a more predictable amount of funds that could be
collected by the Agency in any given year. MDUFA also saw changes to
the performance goals. Compared to MDUFMA, there were fewer performance
goals under MDUFA, yet the goals were more demanding. Specifically,
individual cycle goals were removed and tighter overall goals were
implemented. This was done to facilitate a more interactive review
process. Specific timelines were established under MDUFA for Modular
Premarket Approvals (PMAs) and Real-Time PMA supplements, which were
not included under MDUFMA in 2002. The commitment letter outlining the
goals in the last reauthorization can be found at http://www.fda.gov/
MDUFA. FDA published a number of reports that provide the public with
useful background on MDUFMA, FDAAA, and MDUFA. Key Federal Register
documents, MDUFA-related guidance documents, legislation, performance
reports, and financial reports and plans can be found at http://
www.fda.gov/MDUFA. FDA will also post a webinar on the medical device
user fee program to give the public more background information on the
program. The webinar will be available through the link to the Public
Meeting at http://www.fda.gov/MedicalDevices/NewsEvents/
WorkshopsConferences/ucm218250.htm approximately 10 days before the
public meeting. FDAAA specific information is available at http://
www.fda.gov/RegulatoryInformation/Legislation/
FederalFoodDrugandCosmeticActFDCAct/SignificantAmendmentstotheFDCAct/
FoodandDrugAdministrationAmendmentsActof2007/default.htm.

III. What Information Should You Know About the Meeting?

A. When and Where Will the Meeting Occur? What Format Will FDA Use?

    Through this notice, we are announcing a public meeting to hear
stakeholder views on the reauthorization of the medical device user fee
program, including specific suggestions for any changes to the program
that we should consider. We will conduct the meeting on September 14,
2010. In general, the meeting format will include presentations by FDA
and a series of panels representing different stakeholder interest
groups (such as patient advocates, consumer protection, industry,
health professionals, and academic researchers). We will also provide
an opportunity for individuals to make presentations at the meeting and
for organizations and individuals to submit written comments to the
docket after the meeting. FDA policy issues are beyond the scope of
these reauthorization discussions. Accordingly, the presentations
should focus on program improvements and funding issues, including
specific suggestions for changes to performance goals, and not focus on
policy issues.

B. What Questions Would FDA Like the Public to Consider?

    Please consider the following questions for this meeting:
    1. What is your assessment of the overall performance of the
medical device user fee program thus far?
    2. What aspects of the medical device user fee program should be
retained, changed, or discontinued to further strengthen and improve
the program?

C. Will Meeting Transcripts be Available?

    Please be advised that as soon as a transcript is available, it
will be accessible at http://www.regulations.gov. It may be viewed at
the Division of Dockets Management (see Comments). A transcript will
also be available in either hard copy or on CD-ROM, after submission of
a Freedom of Information request. Written requests are to be sent to
Division of Freedom of Information (HFI-35), Office of Management
Programs, Food and Drug Administration, 5600 Fishers Lane, rm. 6-30,
Rockville, MD 20857.

    Dated: August 6, 2010.
Leslie Kux,
Acting Assistant Commissioner for Policy.
[FR Doc. 2010-19843 Filed 8-12-10; 8:45 am]
BILLING CODE 4160-01-S


Strategic Approach to International Chemicals Management ( SAICM)

Stakeholder Consultation EPA East ( 1200 Constitution Ave., NW, Washington, DC) Room 1153 ( 1st floor)

Wednesday, August 31, 2005 1: 00  3: 00 pm Agenda I. Introductions Charles Auer, EPA David Brown, State Department II. Brief overview of SAICM and Inter sessional Work update Jim Willis, EPA III. Stakeholder comments