RULE 202.	EXEMPTIONS TO RULE 201
            (Adopted 10/18/1971, revised 5/1/1972 and 6/27/1977, readopted 10/23/1978, revised 12/7/1987, 1/11/1988, 1/17/1989, 7/10/1990, 7/30/1991, 11/05/1991, 3/10/1992, 5/10/1994, 6/28/1994, 4/17/1997, 3/17/2005, 1/17/2008, 6/19/2008, 9/20/2010, 1/20/2011, 3/17/2011, 6/21/2012, and 8/25/2016)

 Applicability

An Authority to Construct or Permit to Operate shall not be required for equipment, operations and activities described herein.

 Exceptions

	Notwithstanding any exemption created by this rule, any:

 Equipment, activity or operations proposed by an applicant for use as an Emission Reduction Credit is not exempt.

 Emission unit that functions for distributed electrical generation and is not certified under the regulations of the Air Resources Board is not exempt.

 Definitions

See Rule 102, Definitions, for definitions.

 General Provisions

 The owner or operator shall maintain records which clearly demonstrate that the exemption threshold has not been exceeded. These records shall be made available to the District upon request and shall be maintained for a minimum of three calendar years. Failure to maintain records which meet the above requirements or exceedance of the emission exemption threshold or violation of any District rule may result in the immediate loss of the permit exemption. By accepting the terms of the exemption the owner or operator agrees to allow District personnel access to any records or facilities for inspection per Sections 42303 and 41510 of the California Health and Safety Code and Section 114 of the Clean Air Act.

 For the purposes of demonstrating that the emissions exempted do not exceed the aggregate exemption limit specified in Sections G, H, I, J, K, L, M, N, O, P, Q, R, S, T, U, or V of this Rule the owner or operator may base the demonstration on actual emissions provided the owner or operator keeps material use records in a manner approved by the Control Officer. Otherwise the owner or operator must maintain records that demonstrate that the potential to emit of the equipment will not exceed the applicable aggregate exemption emission limit. When calculating the actual emissions for determining whether the aggregate emission limit in this Rule is exceeded, greenhouse gases shall not be included.

 A permit shall not be required for an agricultural operation at a stationary source that, in aggregate, produces actual emissions less than all of the following:

 50 percent of any applicable emission threshold for a major source in the District,
 5 tons per year of any single Hazardous Air Pollutant, and
 12.5 tons per year of combined Hazardous Air Pollutants.

            For the purposes of determining permitting applicability, fugitive emissions, except fugitive dust emissions, are included in determining aggregate emissions. This exemption shall not apply to an agricultural source required to obtain a Title V permit.
 Trains and aircraft used to transport passengers or freight are exempt from permit requirements.

 Temporary Equipment

            A permit shall not be required for temporary equipment where the projected actual aggregate emissions of all affected pollutants do not exceed 1 ton (except carbon monoxide, which shall not exceed 5 tons) and the use of each individual piece of equipment does not exceed one 60 day period in any consecutive 12 month period. Such equipment shall also meet one of the following requirements:

 the temporary equipment is not part of an existing operating process of a stationary source; or

 the temporary equipment replaces equipment that has qualified for a breakdown pursuant to Rule 505, Breakdown Conditions.

            To qualify for this exemption, the owner or operator shall submit a written request to the Control Officer, who shall make a determination in writing approving or denying the request. This request shall identify the temporary equipment, its location, any equipment being replaced, and shall include the emission calculations and assumptions that demonstrate that the equipment meets the exemption criteria. The temporary project may commence as soon as the written request has been made, however, project commencement with equipment that is later found ineligible for the exemption shall constitute a violation of the District's Rules and Regulations. This exemption shall not apply to equipment used for the specific purpose to control emissions of Toxic Air Contaminants. The owner or operator shall pay any applicable fee pursuant to Rule 210, Fees.

 De minimis Exemption

            Any physical change in an existing stationary source that meets all of the requirements below is exempt. Emission increases shall be based on the uncontrolled potential to emit, less emission reductions achieved through Rule 331, Fugitive Emissions Inspection and Maintenance, and shall not be reduced (netted out) by emission reductions achieved through the removal or control of any component.

 The emission increase for any one emission unit shall not exceed 2.40 pounds per day of any affected pollutant, except carbon monoxide, which shall not exceed 19.20 pounds per day.

 The aggregate emissions increase at the stationary source due to all de minimis physical changes at the stationary source shall not exceed 24.00 pounds per day, except carbon monoxide, which shall not exceed 60.00 pounds per day. Any increase shall be reduced to the extent it is included in the source's potential to emit.

 The physical change does not require a change to any article, machine, equipment or contrivance used to eliminate or reduce or control the issuance of air contaminants.

 The article, machine, equipment or contrivance is not subject to an Airborne Toxic Control Measure adopted by the Air Resources Board.

 The article, machine, equipment or contrivance is not subject to New Source Performance Standards or National Emission Standards for Hazardous Air Pollutants promulgated by the Environmental Protection Agency; or Hazardous Air Pollutant requirements under Section 112 of the Clean Air Act.

 The owner or operator shall maintain a record of each de minimis change, which shall include emission calculations demonstrating that each physical change meets the criteria listed in (a) and (b), above. Such records shall be made available to the District upon request.

 Stationary Source Permit Exemption

            A permit shall not be required for any new, modified or existing stationary source if the uncontrolled actual emissions of each individual affected pollutant from the entire stationary source are below 1.00 ton per calendar year, unless:

 the source is subject to EPA promulgated New Source Performance Standards or National Emission Standards for Hazardous Air Pollutants, or the federal operating permit program (40 CFR Part 70), or Hazardous Air Pollutant requirements of Section 112 of the federal Clean Air Act, or

 the source is subject to a California Air Resources Board Airborne Toxic Control Measure; or

 the source is subject to Public Notification or Risk Reduction under the requirements of California Health and Safety Code Section 44300 et seq.; or

 the Control Officer makes a determination that a permit is necessary to ensure that emissions remain below one ton per year; or

 the source is a new or modified source which emits hazardous air emissions and is located within 1,000 feet from the outer boundary of a school site (Health and Safety Code Section 42301.6, et seq.); or

 the source is listed below and subject to the California Code of Regulations, Title 17, Division 3, Subchapter 10, Article 4, Regulations to Achieve Greenhouse Gas Emission Reductions:

                  Subarticle 2, Semiconductors and Related Devices (Section 95320 et seq.) in effect March 17, 2011.

            Each owner or operator seeking this exemption shall submit a written request to the Control Officer, who shall make a determination in writing approving or denying the request. The owner or operator shall pay any applicable fee pursuant to Rule 210, Fees.

 A permit shall not be required for routine repair or maintenance of permitted equipment, not involving structural changes. As used in this paragraph, maintenance does not include operation.

 A permit shall not be required for equivalent routine replacement in whole or in part of any article, machine, equipment or other contrivance where a Permit to Operate had previously been granted under Rule 201, Permits Required, providing emissions are not increased and there is no potential for violating any ambient air quality standard. An equivalent piece of equipment has a Potential to Emit, operating design capacity or actual demonstrated capacity less than or equal to that of the original piece of equipment, and is subject to the same limitations and permit conditions as the equipment being replaced. The owner or operator shall notify the District within 30 days of an equivalent routine replacement, unless the replacement equipment is identical as to make and model, and routine in which case notification is not required. This provision shall not grant any exemption from New Source Performance Standards.

 Notwithstanding any exemption defined in this rule, no new or modified stationary source that has the potential to emit air contaminants in excess of the amounts specified shall be exempt from permit requirements:

 3.28 pounds per day of lead
 0.04 pounds per day of asbestos
 0.0022 pounds per day of beryllium
 0.55 pounds per day of mercury
 5.48 pounds per day of vinyl chloride
 16.44 pounds per day of fluorides
 38.45 pounds per day of sulfuric acid mist, or
 54.79 pounds per day of total reduced sulfur or reduced sulfur compounds.
 0.0000035 tons per year municipal waste combustor organics.
 15 tons per year municipal waste combustor metals.
 40 tons per year municipal waste combustor acid gases.
 In addition, notwithstanding any exemption defined in this rule, no stationary source that has the potential to emit any air contaminants in excess of the amounts specified shall be exempt from permit requirements:

 more than one gallon per year of any one of the exempt compounds listed below. The one gallon per year per stationary source limit is a per compound limit for each compound in aggregate for the entire stationary source and includes any amounts of the compound used in mixed or diluted product.

 dimethyl carbonate; or
 methyl formate; HCOOCH3; or
 HCFC-225ca (3,3-dichloro-1,1,1,2,2-pentafluoropropane); or
 HCFC-225cb (1,3-dichloro-1,1,2,2,3-pentafluoropropane); or
 HFC-43-10mee (1,1,1,2,3,4,4,5,5,5-decafluoropentane); or
 HFC-245fa (1,1,1,3,3-pentafluoropropane); or
 HFC-365mfc (1,1,1,3,3-pentafluorobutane); or
 HFE-7100; (CF3)2CFCF2OCH3; (2-(difluoromethoxymethyl)-1,1,1,2,3,3,3-heptafluoropropane); or
 HFE-7100; C4F9OCH3; (1,1,1,2,2,3,3,4,4-nonafluoro-4-methoxy-butane); or

 more than one gallon per year of tertiary-butyl acetate; C6H12O2 ("acetic acid, 1,1-dimethylethyl ester"). Tertiary-butyl acetate (also known as t-butyl acetate or tBAc) shall be considered exempt as a reactive organic compound only for purposes of reactive organic compound emissions limitations or reactive organic compound content requirements and shall be considered a reactive organic compound for purposes of all recordkeeping, emissions reporting, photochemical dispersion modeling, and inventory requirements which apply to reactive organic compounds. The one gallon per year per stationary source limit for tertiary-butyl acetate is an aggregate limit for the entire stationary source and includes any amounts of the compound used in mixed or diluted product.

 Where an exemption is described in this rule for a general category of equipment, the exemption shall not apply to any component which otherwise would require a permit under the provisions of these Rules and Regulations.

 Emission control equipment, directly attached to equipment which is exempt from permit by provisions of this Rule, is exempt.

 A change in location of an emission unit within the boundaries of a stationary source shall not require a permit modification unless the location of the equipment is prescribed in the source's permit and a specific location was assumed in an Air Quality Impact Analysis or a Health Risk Assessment that formed the basis of the issuance of the permit.

 Application of architectural coating in the repair and maintenance of a stationary structure is exempt from permit requirements.

 For the purposes of the exemptions set forth in F.1.e, F.1.f, F.1.g, and G.1, the ratings of all engines or combustion equipment used in the same process shall be accumulated to determine whether these exemptions apply.

 Notwithstanding any exemption in these rules and regulations, if the combined emissions from all construction equipment used to construct a stationary source which requires an Authority to Construct have a projected actual in excess of 25 tons of any pollutant, except carbon monoxide, in a 12 month period, the owner of the stationary source shall provide offsets as required under the provisions of Rule 804, Offsets, and shall demonstrate that no ambient air quality standard would be violated.

 No additional permit shall be required at a stationary source in the District for equipment permitted by the District for various location uses provided the following conditions are met:

 The owner or operator of the equipment has a valid Permit to Operate issued by the District that specifically denotes the equipment as being usable at various locations within the District and that the terms and conditions of the Permit to Operate are fully complied with.

 The equipment is not used to replace equipment which is part of an existing process at the stationary source.

 The equipment is used for repair and maintenance related purposes only.

 The stationary source reports all uses (including the start and end dates) and associated emissions for each use under this exemption to the District in their next annual report (or semi-annual report for Part 70 sources).

 Any structure designed for and used exclusively as a dwelling for not more than four families and any incinerator used exclusively in connection with such structure.

 Compliance with Rule Changes

      The provisions of this section shall apply when an exemption for existing equipment is removed by revision of this Rule. The equipment owner shall file a complete application for a permit required by the exemption change within ninety (90) days after adoption of the revised rule; or for sources on the Outer Continental Shelf, within 90 days after the date the revision to this Rule is added to the Outer Continental Shelf Air Regulations (40 CFR Part 55). If no application is filed within the ninety (90) day period, the application filing fee prescribed in Rule 210, Fees, shall be doubled and the equipment owner shall be subject to a Notice of Violation and to the penalty provisions set forth in California Health and Safety Code Sections 42400 et seq.

      If an application is filed within the ninety (90) day filing period after adoption of the revised rule but the application is deemed incomplete by the District, the applicant shall be notified by the District that a complete application must be filed within thirty (30) days of the notification. If a complete application is not received within thirty (30) days after the notification, the prescribed filing fee shall be doubled and the owner of the equipment shall be subject to the penalty provisions set forth in California Health and Safety Code Sections 42400 et seq.
 Internal Combustion Engines

 A permit shall not be required for internal combustion engines if any of the following conditions is satisfied:

 Engines used in aircraft and in locomotives;

 Engines used to propel marine vessels, except vessels associated with a stationary source which shall be regulated as specified under the provisions of Regulation VIII.

 Engines used to propel vehicles, as defined in Section 670 of the California Vehicle Code, but not including any engine mounted on such vehicles that would otherwise require a permit under the provisions of these Rules and Regulations.

 Spark ignition piston-type internal combustion engines used exclusively for emergency electrical power generation or emergency pumping of water for flood control or firefighting if the engine operates no more than 200 hours per calendar year, and where a record is maintained and is available to the District upon request; the record shall list the identification number of the equipment, the number of operating hours on each day the engine is operated and the cumulative total hours.

 Compression ignition engines with a rated brake horsepower of less than 50. No compression ignition engine otherwise subject to permit shall be exempt because it has been derated.

 Spark ignition piston-type internal combustion engines with a rated brake horsepower of less than 50. Notwithstanding the previous sentence, none of the individual engines in the range of less than 50 but greater than 20 rated brake horsepower are exempt if such engines at a stationary source have a total rated brake horsepower rating of 400 or greater.

No spark ignition piston-type internal combustion engine otherwise subject to permit shall be exempt because it has been derated. Spark ignition piston-type internal combustion engines exempt under other provisions of Section F and permitted spark ignition piston-type internal combustion engines shall not count toward the 400 rated brake horsepower aggregate limit.

 Gas turbine engines with a maximum heat input rating of 3 million British thermal units per hour or less at standard conditions. No gas turbine engine otherwise subject to permit shall be exempt because it has been derated. For the purposes of this section, power generating microturbines fired on natural gas which meets General Order 58-A of the Public Utility Commission that have been certified by the Air Resources Board to meet the applicable distributed generation standards certified by a current Air Resources Board Executive Order are not subject to the provisions of Section D.15 if the potential annual emissions of each affected pollutant does not exceed 1 ton (except carbon monoxide, which shall not exceed 5 tons).

 A permit shall not be required for portable engines registered in the Statewide Registration Program, pursuant to California Code of Regulations, title 13, section 2451 et seq. and Health and Safety Code Section 41753 et seq. Notwithstanding this provision, the requirements of Section D.16 shall apply to such portable engines. All operators using this permit exemption shall comply with the State Portable Equipment Registration Program and Air Resources Board-issued registration.

 A permit shall not be required for engines used for aircraft shows or to power amusement rides at seasonal or special occasion shows, fairs, expositions, circuses or carnival events, provided that the duration of such event is less than 18 days in any calendar year.

 A permit shall not be required for engines with a rated brake horsepower of less than 50 used:

 for military tactical support operations including maintenance and training for such operations;

 to power temperature and humidity control systems on cargo trailers used to transport satellites and space launch equipment;

 exclusively for space launch facility support and which power hoists, jacks, pulleys, and other cargo handling equipment permanently affixed to motor vehicles or trailers pulled by motor vehicles.

 A permit shall not be required for specialty equipment. To qualify for this exemption, the owner or operator of the stationary source shall submit a written request to the Control Officer, who shall make a determination in writing approving or denying the request. The owner or operator shall pay any applicable fee pursuant to Rule 210, Fees. For specialty equipment emergency use, operations may commence as soon as the written request has been made; however, operation of equipment which is later found ineligible for the exemption shall constitute a violation of the District's Rules and Regulations.

 An internal combustion engine which powers an item of equipment identified as exempt in any other part of this rule is not exempt unless the engine qualifies for an exemption pursuant to this rule.

 A permit shall not be required for equipment, including associated marine vessels, used for pile driving adjacent to or in waterways, or cable and pipe-laying vessels/barges or derrick barges if the potential to emit of such equipment per stationary source is less than 25 tons per year of any affected pollutant during any consecutive 12 month period. The Control Officer shall not require Best Available Control Technology for such sources if federal law preempts this requirement. To qualify for this exemption, the owner or operator of the stationary source shall submit a written request for exemption to the Control Officer, who shall make a determination in writing approving or denying the request. The request shall identify the equipment, its location, and shall include the emission calculations and assumptions that demonstrate that the equipment meets the exemption criteria. The owner or operator shall pay any applicable fee pursuant to Rule 210, Fees. Alternatively, an owner or operator of the stationary source may qualify for an exemption from the New Source Review provisions of Regulation VIII by obtaining an Authority to Construct and Permit to Operate which limits the potential to emit of such equipment to less than 25 tons per year of any affected pollutant during any consecutive 12 month period.

 For purposes of Regulation VIII, the following shall not be subject to New Source Review: Marine vessel engines (propulsion engines, auxiliary engines and permanently affixed support engines) associated with construction, maintenance, repair and/or demolition activities at a stationary source provided the duration of the activities do not exceed 12 consecutive months and the potential to emit of such engines per stationary source is less than 10 tons per stationary source of oxides of nitrogen, oxides of sulfur, reactive organic compounds or particulate matter. To qualify for this exemption, the owner or operator of the stationary source shall submit a written request for exemption to the Control Officer, who shall make a determination in writing approving or denying the request. The request shall identify the marine vessels, project activities, duration, and shall include the emission calculations and assumptions demonstrating that the engines meet the exemption criteria. The owner or operator shall pay any applicable fee pursuant to Rule 210, Fees. Alternatively, an owner or operator of the stationary source may qualify for an exemption by obtaining an Authority to Construct and Permit to Operate which limits the potential to emit of such equipment to less than 10 tons per year. Such Authority to Construct/Permit to Operate shall be exempt from Regulation VIII.

 Combustion Equipment (Other than Internal Combustion Engines)

      Notwithstanding the listed exemptions, any collection of articles, machines, equipment or other contrivances within each listed equipment category at a stationary source that has aggregate emissions in excess of 25 tons per calendar year of any affected pollutant is not exempt.

 Combustion equipment with a maximum heat input of less than or equal to two (2) million British thermal units per hour is exempt from permit requirements if fired exclusively with one of the following:

 Natural or produced gas which meets General Order 58-A of the Public Utility Commission,

 Liquefied petroleum gas, which meets Gas Processors Association Standards,

 A combination of natural or produced and liquefied petroleum gas, meeting the requirements of subdivisions (a) and (b) above.

            Combustion equipment with a maximum heat input rate of 1 million British thermal units per hour or less is exempt and does not count towards the 25 tons per calendar year stationary source exemption threshold listed above, provided the equipment is fired exclusively with fuel listed above in a, b, or c. No combustion equipment otherwise subject to permit shall be exempt because it has been derated.

 Combustion equipment (other than internal combustion engines) which provides heat energy to any item of equipment identified as exempt in any other part of this rule, is not exempt unless the combustion equipment is exempt as specified in G.1.

 Combustion equipment (other than internal combustion engines) identified as exempt in any other section of this rule does not count toward the 25 ton per year aggregate emission limit.

 Abrasive Blast Equipment

      The following listed abrasive blast equipment is exempt from permit requirements. Notwithstanding the listed exemptions, any collection of articles, machines, equipment or other contrivances within each listed equipment category at a stationary source that has aggregate emissions in excess of 10 tons per calendar year of any affected pollutant is not exempt.

 Abrasive blast cabinet-dust filter integral combination units where the total internal volume of the blast section is 50 cubic feet or less.

 Blast cleaning equipment using a suspension of abrasive in water.

 All portable abrasive blast equipment, excluding any internal combustion engine associated with such equipment which must comply with the requirements of Section F. of this rule.

 Coatings Applications Equipment and Operations

      The following listed coating applications equipment and operations is exempt from permit requirements. Notwithstanding the listed exemptions, any collection of articles, machines, equipment or other contrivances within each listed equipment category at a stationary source that has aggregate emissions in excess of 10 tons per calendar year of any affected pollutant is not exempt.

 Dipping operations for coating objects with oils, waxes or greases where no organic solvents, diluents or thinners are used.

 Dipping operations for applying coatings of natural or synthetic resins which contain no organic solvents.

 Equipment used in surface coating operations provided that the total amount of coatings and solvents used does not exceed 55 gallons per year. Solvents meeting the criteria of Section U.2.b or Section U.2.c or that have a reactive organic compound content of 50 grams per liter or less, as determined by the South Coast Air Quality Management District Method 313-91, "Determination of Volatile Organic Compounds by Gas Chromatography-Mass Spectrometry," June 1993, or any other test methods approved by the Environmental Protection Agency, the Air Resources Board, and the Control Officer, do not contribute to the 55 gallons per year per stationary source limitation. However, such sources need not obtain permits for air pollution control equipment (i.e., spray booths, carbon adsorbers, incinerators, thermal oxidizers, dust collectors, etc.) unless control equipment is required by District prohibitory rules. For equipment owned or operated by a stationary source owner or operator and used as part of the stationary source operations, the 55 gallon per year exemption shall be based on the total coatings and solvents usage of all such equipment at the stationary source.

            To qualify for this exemption, the owner or operator shall maintain records of the amount of coating and/or solvents used for each calendar year. These records shall be kept for a minimum of 3 years and be made available to the District on request.

 Air brushing operations.

 Powder coating operations, provided the powder coating material reactive organic compound content is equal to or less than five percent, by weight.

 Unheated non-conveyorized coating dip tanks of 100 gallons or less capacity.

 Drycleaning and Fabric Related Equipment and Operations

      The following listed drycleaning and fabric related equipment and operations is exempt from permit requirements. Notwithstanding the listed exemptions, any collection of articles, machines, equipment or other contrivances within each listed equipment category at a stationary source that has aggregate emissions in excess of 10 tons per calendar year of any affected pollutant is not exempt.

 Equipment used exclusively for the dyeing or stripping (bleaching) of textiles where no organic solvents, diluents or thinners are used.

 Lint traps used exclusively in conjunction with dry cleaning tumblers.

 Laundry dryers, extractors or tumblers used for fabrics cleaned only with water solutions of bleach or detergents.

 Food Processing and Preparation Equipment

      The following listed food processing and preparation equipment is exempt from permit requirements. Notwithstanding the listed exemptions, any collection of articles, machines, equipment or other contrivances within each listed equipment category at a stationary source that has aggregate emissions in excess of 10 tons per calendar year of any affected pollutant is not exempt.

 Equipment used in eating establishments for the purpose of preparing food for human consumption.

 Smokehouses in which the maximum horizontal inside cross-sectional area does not exceed 20 square feet

 Ovens, mixers and blenders used in bakeries where the products are edible and intended for human consumption.

 Confection cookers where the products are edible and intended for human consumption.

 Equipment used exclusively to grind, blend or package tea, cocoa, spices or roasted coffee.

 Barbecue Equipment.

 Fermentation, aging, and bottling process operations conducted at wineries, breweries, distilleries and similar facilities, provided the projected actual emissions from such operations for each individual affected pollutant from the entire stationary source are below 1.00 ton per calendar year. To qualify for this exemption, the owner or operator shall submit a written request to the Control Officer, who shall make a determination in writing approving or denying the request. The owner or operator shall pay any applicable fee pursuant to Rule 210, Fees.

 General Utility Equipment and Operations

      The following listed general utility equipment and operations is exempt from permit requirements. Notwithstanding the listed exemptions, any collection of articles, machines, equipment or other contrivances within each listed equipment category at a stationary source that has aggregate emissions in excess of 10 tons per calendar year of any affected pollutant is not exempt.

 Heat exchangers.

 Comfort air conditioning or comfort ventilating systems which are not designed to remove air contaminants generated by or released from specific units or equipment.

 Refrigeration units except those used as, or in conjunction with, air pollution control equipment.

 Water cooling towers and water cooling ponds not used for evaporative cooling of process water or not used for evaporative cooling of water from barometric jets or from barometric condensers.

 Equipment used exclusively for steam cleaning.

 Equipment used exclusively for space heating.

 Compressors of, and holding tanks for, dry natural gas.

 Natural draft hoods, natural draft stacks or natural draft ventilators where natural draft means the flow of gases is not augmented by mechanical means.

 Vacuum cleaning systems used exclusively for industrial, commercial or residential housekeeping purposes.

 Rail cleaning operations.

 Aerobic wastewater treatment equipment, including primary/secondary settling, trickling filter, and sludge drying beds.

 Ozone generators used for water treatment, provided that the ozone is not released to the atmosphere.

 Water well, water filtration systems, reverse osmosis units.

 Fuel Cells, and any associated fuel input conditioning exclusively servicing such fuel cell, in which electro-chemically reactive materials are supplied to a cell and consumed to produce electricity.

 Notwithstanding G.2 of this rule, portable steam cleaning/pressure washing equipment with maximum heat input rating less than 1 million British thermal units per hour fired exclusively on diesel fuel.

 Notwithstanding G.2 of this rule, portable water heaters used exclusively for underwater diving activities with a maximum heat input rating less than 1 million British thermal units per hour fired exclusively on diesel fuel.

 Glass, Ceramic, Metallurgical Processing and Fabrication Equipment and Operations

      The following glass, ceramic, metallurgical processing and fabrication equipment and operations is exempt from permit requirements. Notwithstanding the listed exemptions, any collection of articles, machines, equipment or other contrivances within each listed equipment category at a stationary source that has aggregate emissions in excess of 10 tons per calendar year of any affected pollutant is not exempt.

 Porcelain enameling furnaces, porcelain enameling drying ovens, vitreous enameling furnaces or vitreous enameling ovens.

 Crucible type or pot type furnaces, except those specified in M.8, with a brimful capacity of less than 463 cubic inches of any molten metal.

 Kilns used for firing ceramic ware.

 Equipment used exclusively for forging, pressing, rolling or drawing of metals or for heating metals immediately prior to forging, pressing, rolling or drawing.

 Equipment used exclusively for the sintering of glass or metals.

 Equipment used for washing or drying products fabricated from metal or glass, provided that no volatile organic materials are used in the process and that no oil or solid fuel is burned.

 Equipment used exclusively for heat treating glass or metals, or used exclusively for case hardening, carburizing, cyaniding, nitriding, carbonitriding, siliconizing, or diffusion treating of metal objects.

 Crucible furnaces, pot furnaces or induction furnaces, with a capacity of 1000 pounds or less each, in which no sweating or distilling is conducted and from which only the following metals are poured or in which only the following metals are held in a molten state:

 Aluminum or any alloy containing over 50 percent aluminum.
 Magnesium or any alloy containing over 50 percent magnesium.
 Lead or any alloy containing over 50 percent lead.
 Tin or any alloy containing over 50 percent tin.
 Zinc or any alloy containing over 50 percent zinc.
 Copper or any alloy containing over 50 percent copper.
 Precious metals.

 Tumblers used for the cleaning or deburring of metal products without abrasive blasting.

 Shell core and shell-mold manufacturing machines.

 Molds used for the casting of metals.

 Equipment used for inspection of metal products.

 Die casting machines.

 Atmosphere generators used in connection with metal heat treating processes.

 Brazing, soldering or welding equipment.

 Foundry sand mold forming equipment to which no heat is applied.

 Equipment using aqueous solutions for the surface preparation, cleaning, stripping or etching (does not include chemical milling) of the following base metals: brass, bronze, copper, iron, lead, nickel, tin, zinc or precious metals provided that volatile organic materials used in the aqueous solutions do not exceed one percent by volume.

 Laboratory Equipment and Operations

      The following laboratory equipment and operations is exempt from permit requirements. Notwithstanding the listed exemptions, any collection of articles, machines, equipment or other contrivances within each listed equipment category at a stationary source that has aggregate emissions in excess of 10 tons per calendar year of any affected pollutant is not exempt.

 Laboratory equipment used exclusively for chemical or physical analyses and bench scale laboratory equipment.

 Vacuum producing devices used in laboratory operations.

 Material Working and Handling Equipment and Operations

      The following material working and handling equipment and operations is exempt from permit requirements. Notwithstanding the listed exemptions, any collection of articles, machines, equipment or other contrivances within each listed equipment category at a stationary source that has aggregate emissions in excess of 10 tons per calendar year of any affected pollutant is not exempt.

 Presses used exclusively for extruding metals, minerals, plastics or wood.

 Equipment used exclusively to mill or grind coating and molding compounds where all materials charged are in a paste form.

 Equipment used for buffing (except automatic or semi-automatic tire buffers) or polishing, carving, cutting, drilling, machining, routing, sanding, sawing, surface grinding, or turning of ceramic artwork, ceramic precision parts, leather, metals, plastics, rubber, fiberboard, masonry, carbon or graphite.

 Equipment used for carving, cutting, drilling, surface grinding, planing, routing, sanding, sawing, shredding or turning of wood, or the pressing or storing of sawdust, wood chips or wood shavings.

 Miscellaneous Equipment and Operations

      The following miscellaneous equipment and operations is exempt from permit requirements. Notwithstanding the listed exemptions, any collection of articles, machines, equipment or other contrivances within each listed equipment category at a stationary source that has aggregate emissions in excess of 10 tons per calendar year of any affected pollutant is not exempt.

 Transporting materials on streets and highways.

 Equipment used exclusively for the melting or applying of wax where no organic solvents, diluents or thinners are used.

 Equipment used for hydraulic or hydrostatic testing.

 Equipment used exclusively for binding lining to brake shoes.

 Equipment used exclusively for the manufacture of water emulsions of asphalt, greases, oils or waxes.

 Equipment used exclusively for the mixing and blending of materials at ambient temperature to make water based adhesives.

 Equipment used to liquefy or separate oxygen, nitrogen or the rare gases from the air.

 Paving activities except scarification, "cutback" asphalt or batch plant operations at paving sites.

 Equipment used for bioremediation of diesel and crude oil contaminated soil.

 Safety flares used for emergencies or for search and rescue operations.

 Fire training facilities necessary for the instruction of public or industrial employees in the methods of fire fighting.

 Flares used to combust gaseous hydrogen during rocket fueling operations.

 Explosive ordnance detonation.

 For purposes of Regulation VIII, the following shall not be subject to New Source Review: Marine vessel engines (propulsion engines, auxiliary engines and permanently affixed support engines) associated with launch vehicle recovery operations for the Missile Defense Agency's Airborne Laser program provided the potential to emit is less than 5 tons per year of oxides of nitrogen, oxides of sulfur, reactive organic compounds or particulate matter. To qualify for this exemption, the owner or operator of the stationary source shall submit a written request for exemption to the Control Officer, who shall make a determination in writing approving or denying the request. The request shall identify the marine vessels, project activities, duration, and shall include the emission calculations and assumptions demonstrating that the engines meet the exemption criteria. The owner or operator shall pay any applicable fee pursuant to Rule 210, Fees. Alternatively, an owner or operator of the stationary source may qualify for an exemption by obtaining an Authority to Construct and Permit to Operate which limits the potential to emit of such equipment to less than 5 tons per year. Such Authority to Construct/Permit to Operate shall be exempt from Regulation VIII.

 Mixing, Blending and Packaging Equipment and Operations

      The following mixing, blending, and packaging equipment and operations is exempt from permit requirements. Notwithstanding the listed exemptions, any collection of articles, machines, equipment or other contrivances within each listed equipment category at a stationary source that has aggregate emissions in excess of 10 tons per calendar year of any affected pollutant is not exempt.

 Batch mixers of 5 cubic feet rated working capacity or less.

 Equipment used exclusively for the packaging of lubricants or greases.

 Equipment used exclusively to package pharmaceuticals and cosmetics or to coat pharmaceutical tablets.

 Plastics, Composite and Rubber Processing Equipment and Operations

      The following plastics, composite and rubber processing equipment and operations is exempt from permit requirements. Notwithstanding the listed exemptions, any collection of articles, machines, equipment or other contrivances within each listed equipment category at a stationary source that has aggregate emissions in excess of 10 tons per calendar year of any affected pollutant is not exempt.

 Ovens used exclusively for the curing of plastics which are concurrently being vacuum held to mold or for the softening or annealing of plastics.

 Ovens used exclusively for the curing of vinyl plastisols by the closed mold curing process.

 Ovens used exclusively for curing potting materials or casting made with epoxy resins.

 Presses used for the curing of rubber products and plastic products.

 Equipment used exclusively for conveying and storing plastic pellets.

 Equipment used for compression molding and injection molding of plastics.

 Mixers for rubber or plastics where no material in powder form is added and no organic diluents or thinners are emitted.

 Roll mills or calendars for rubber or plastics where no organic diluents or thinners are emitted.

 Printing and Reproduction Equipment and Operations

      The following printing and reproduction equipment and operations is exempt from permit requirements. Notwithstanding the listed exemptions, any collection of articles, machines, equipment or other contrivances within each listed equipment category at a stationary source that has aggregate emissions in excess of 10 tons per calendar year of any affected pollutant is not exempt.

 All sheet-fed printing presses, and all other printing presses without dryers, excluding rotogravure and flexographic printing presses.

 Platen presses used for laminating.

 Photographic process equipment by which an image is reproduced upon material sensitized to radiant energy.

 Stenciling and dyeing operations.

 Semiconductor and Electronics Manufacturing Equipment and Operations

      The following semiconductor and electronics manufacturing equipment and operations is exempt from permit requirements. Notwithstanding the listed exemptions, any collection of articles, machines, equipment or other contrivances within each listed equipment category at a stationary source that has aggregate emissions in excess of one ton per calendar year of any affected pollutant is not exempt. Notwithstanding the listed exemptions, any article, machine, equipment or other contrivance that utilizes or creates fluorinated gas(es) or uses fluorinated heat transfer fluids is not exempt.

 Vacuum deposition.

 Ion implantation.

 Sputtering.

 Ozone/plasma/ion etching or ashing.

 Vacuum bake systems.

 Furnaces used for crystal growth, liquid phase epitaxial, compounding and/or refining, and carbon coating.

 Automated epoxy adhesive, potting compound, conformal coating dispensing machines and associated equipment used for mixing, injection and curing.

 Ovens used exclusively for curing epoxies and adhesives. Ovens used exclusively for curing permitted paint application processes.

 Ovens for drying parts cleaned with water.

 Solvent Application Equipment and Operations

      The following solvent cleaning, solvent cleaning machines and their operations are exempt from permit requirements. Notwithstanding the listed exemptions, any collection of articles, machines, equipment or other contrivances within each listed equipment category at a stationary source that has aggregate emissions in excess of 10 tons per calendar year of any affected pollutant is not exempt.

 Unheated nonconveyorized solvent rinsing containers of 1.00 gallon or less capacity provided that solvent cleaning performed in association with such containers complies with the requirements in Rule 321, Solvent Cleaning Machines and Solvent Cleaning.

 Single solvent cleaning machines, which use unheated solvent, and which:

 have a liquid surface area (i.e., the area of the drain for remote reservoir cleaning machines or the solvent/air interface area for other solvent cleaning machines) of less than 929 square centimeters (1.0 square foot), unless the aggregate liquid surface area of all solvent cleaning machines at a stationary source, covered by this exemption is greater than 0.929 square meter (10 square feet), or

 use only solvents with an initial boiling point of 150 degrees Celsius (302 degrees Fahrenheit) or greater as determined by ASTM D-1078-05, "Standard Test Method for Distillation Range of Volatile Organic Liquids," ASTM International, or

 use solvents with a reactive organic compound content of two percent or less by weight as determined by the South Coast Air Quality Management District Method 313-91, "Determination of Volatile Organic Compounds by Gas Chromatography-Mass Spectrometry," June 1993, or any other test methods approved by the Environmental Protection Agency, the Air Resources Board, and the Control Officer.

 The liquid surface area of any solvent cleaning machine using the following solvent shall not be counted towards the 0.929 square meter (10 square feet) aggregate limit in subsection a. above:

 any solvent that has a reactive organic compound content of 50 grams per liter or less, as determined by the South Coast Air Quality Management District Method 313-91, "Determination of Volatile Organic Compounds by Gas Chromatography-Mass Spectrometry," June 1993, or any other test methods approved by the Environmental Protection Agency, the Air Resources Board, and the Control Officer; or

 any solvent exempt pursuant to subsection b. or subsection c. above.

 Wipe cleaning operations, provided that the solvents used do not exceed 55 gallons per year per stationary source and that the solvent cleaning complies with the requirements in Rule 321, Solvent Cleaning Machines and Solvent Cleaning.

To qualify for this exemption, the owner or operator shall maintain records of the amount (gallons per year) of solvents used for wipe cleaning at the stationary source for each calendar year. These records shall be maintained on site for at least 3 years and be made available to the District on request. Thereafter, the records shall be maintained either on site or readily available for expeditious inspection and review for an additional 2 years.

            Solvents meeting the criteria of 2.b. or c. above or that have a reactive organic compound content of 50 grams per liter or less, as determined by the South Coast Air Quality Management District Method 313-91, "Determination of Volatile Organic Compounds by Gas Chromatography-Mass Spectrometry," June 1993, or any other test methods approved by the Environmental Protection Agency, the Air Resources Board, and the Control Officer, do not contribute to the 55 gallons per year per stationary source limitation.

 Notwithstanding the Section U.3 exemption above, solvent cleaning to disinfect and decontaminate surfaces and equipment in hospitals, clinics, medical facilities, dentistry facilities, and other health care facilities, including but not limited to, sanatoriums, convalescent hospitals, convalescent homes, skilled nursing facilities, nursing homes, blood banks, and bloodmobiles.

 Notwithstanding the Section U.3 exemption above, solvent cleaning associated with janitorial cleaning, including graffiti removal.

 Storage and Transfer Equipment and Operations

      The following storage and transfer equipment and operations are exempt from permit requirements. Notwithstanding the listed exemptions, any collection of articles, machines, equipment or other contrivances within each listed equipment category at a stationary source that has aggregate emissions in excess of 10 tons per calendar year of any affected pollutant is not exempt. Containers, reservoirs, tanks, sumps or ponds with a capacity of 55 gallons or less are exempt and do not count towards the 10 ton per year aggregation threshold.

 Unheated storage of liquid organic materials, except refined fuel oils, with an initial boiling point of 300°F or greater at one atmosphere pressure.

 Storage of refined fuel oils with an American Petroleum Institute gravity of 40 degrees or lower as determined by ASTM D-4057-06, "Standard Practice for Manual Sampling of Petroleum and Petroleum Products," ASTM International.

 Storage of lubricating oils.

 Storage of organic liquids except gasoline, normally used as solvents, diluents or thinners, inks, colorants, paints, lacquers, enamels, varnishes, liquid resins or other surface coatings, and having a capacity of 1,500 gallons or less.

 Storage of liquid soaps, liquid detergents, vegetable oils, waxes or wax emulsions.

 Storage of asphalt.

 The storage of gasoline (defined as any petroleum distillate having a Reid vapor pressure of 4.0 pounds per square inch or greater) having a capacity of less than 250 gallons.

 Storage of liquefied or compressed gases which do not exceed Gas Processors Association specifications for maximum volatile sulfur content of commercial grade liquefied petroleum gas.

 Tanks, vessels and pumping equipment used exclusively for the storage or dispensing of fresh commercial or purer grades of:

 Sulfuric acid with an acid strength of 99 percent or less by weight.

 Phosphoric acid with an acid strength of 99 percent or less by weight.

 Nitric acid with an acid strength of 70 percent or less by weight.

 Closed loop transfer of rocket propellant from a tanker truck, cylindrical tank, or drum, to a satellite, satellite placement system, nutation control system, apogee kick motor, or any other non-booster segment of a space launch vehicle, provided there is no venting of vapors to the atmosphere during the propellant transfer.


[Federal Register Volume 85, Number 95 (Friday, May 15, 2020)]
[Notices]
[Pages 29461-29463]
[FR Doc No: 2020-10492]

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

DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2020-D-0987]

Policy for Coronavirus Disease-2019 Tests During the Public
Health Emergency; Immediately in Effect Guidance for Clinical
Laboratories, Commercial Manufacturers, and Food and Drug
Administration Staff; Availability

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice of availability.

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

SUMMARY: The Food and Drug Administration (FDA or Agency) is announcing
the availability of a final guidance entitled ``Policy for Coronavirus
Disease-2019 Tests During the Public Health Emergency.'' On February 4,
2020, the Secretary of Health and Human Services (HHS) determined that
there is a public health emergency and that circumstances exist
justifying the authorization of emergency use of in vitro diagnostics
for detection and/or diagnosis of the novel coronavirus (2019-nCoV).
Rapid detection of Coronavirus Disease-2019 (COVID-19) cases in the
United States requires wide availability of SARS-CoV-2 testing. This
guidance was revised on March 16, 2020, May 4, 2020, and May 11, 2020.
The guidance describes four policies intended to help facilitate the
development and use of SARS-CoV-2 tests during the public health
emergency: Two policies for accelerating the development of certain
laboratory tests for COVID-19--one leading to an Emergency Use
Authorization (EUA) submission to FDA and the other not leading to an
EUA submission when the test is developed under the authorities of the
State in which the laboratory resides and the State takes
responsibility for COVID-19 testing by laboratories in its State; a
policy for commercial manufacturers to more rapidly distribute their
SARS-CoV-2 diagnostics to laboratories for specimen testing after
validation while an EUA submission is being prepared for submission to
FDA; and a policy regarding the use of serological testing. In
addition, FDA has included a reference to the availability, on FDA's
website, of templates for commercial manufacturers and laboratories
intended to facilitate EUA submissions for molecular, antigen, and
serology tests. The guidance document is immediately in effect, but it
remains subject to comment in accordance with the Agency's good
guidance practices.

DATES: The announcement of the guidance is published in the Federal
Register on May 15, 2020.

ADDRESSES: You may submit either electronic or written comments on
Agency guidances at any time as follows:

Electronic Submissions

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

Written/Paper Submissions

    Submit written/paper submissions as follows:
     Mail/Hand delivery/Courier (for written/paper
submissions): Dockets Management Staff (HFA-305), Food and Drug
Administration, 5630 Fishers Lane, Rm. 1061, Rockville, MD 20852.
     For written/paper comments submitted to the Dockets
Management Staff, FDA will post your comment, as well as any
attachments, except for information submitted, marked and identified,
as confidential, if submitted as detailed in ``Instructions.''
    Instructions: All submissions received must include the Docket No.
FDA-2020-D-0987 for ``Policy for Coronavirus Disease-2019 Tests During
the Public Health Emergency.'' Received comments will be placed in the
docket

and, except for those submitted as ``Confidential Submissions,''
publicly viewable at https://www.regulations.gov or at the Dockets
Management Staff between 9 a.m. and 4 p.m., Monday through Friday.
     Confidential Submissions--To submit a comment with
confidential information that you do not wish to be made publicly
available, submit your comments only as a written/paper submission. You
should submit two copies total. One copy will include the information
you claim to be confidential with a heading or cover note that states
``THIS DOCUMENT CONTAINS CONFIDENTIAL INFORMATION.'' The Agency will
review this copy, including the claimed confidential information, in
its consideration of comments. The second copy, which will have the
claimed confidential information redacted/blacked out, will be
available for public viewing and posted on https://www.regulations.gov.
Submit both copies to the Dockets Management Staff. If you do not wish
your name and contact information to be made publicly available, you
can provide this information on the cover sheet and not in the body of
your comments and you must identify this information as
``confidential.'' Any information marked as ``confidential'' will not
be disclosed except in accordance with 21 CFR 10.20 and other
applicable disclosure law. For more information about FDA's posting of
comments to public dockets, see 80 FR 56469, September 18, 2015, or
access the information at: https://www.govinfo.gov/content/pkg/FR-2015-09-18/pdf/2015-23389.pdf.
    Docket: For access to the docket to read background documents or
the electronic and written/paper comments received, go to https://www.regulations.gov and insert the docket number, found in brackets in
the heading of this document, into the ``Search'' box and follow the
prompts and/or go to the Dockets Management Staff, 5630 Fishers Lane,
Rm. 1061, Rockville, MD 20852.
    You may submit comments on any guidance at any time (see Sec.
10.115(g)(5) (21 CFR 10.115(g)(5))).
    An electronic copy of the guidance document is available for
download from the internet. See the SUPPLEMENTARY INFORMATION section
for information on electronic access to the guidance. Submit written
requests for a single hard copy of the guidance document entitled
``Policy for Coronavirus Disease-2019 Tests During the Public Health
Emergency'' to the Office of Policy, Guidance and Policy Development,
Center for Devices and Radiological Health, Food and Drug
Administration, 10903 New Hampshire Ave., Bldg. 66, Rm. 5431, Silver
Spring, MD 20993-0002. Send one self-addressed adhesive label to assist
that office in processing your request.

FOR FURTHER INFORMATION CONTACT: Brittany Schuck, Center for Devices
and Radiological Health, Food and Drug Administration, 10903 New
Hampshire Ave., Bldg. 66, Rm. 3556, Silver Spring, MD 20993-0002, 301-
796-5199.

SUPPLEMENTARY INFORMATION:

I. Background

    FDA is announcing the availability of a guidance entitled ``Policy
for Coronavirus Disease-2019 Tests During the Public Health
Emergency.'' On February 4, 2020, the Secretary of HHS determined that
there is a public health emergency and that circumstances exist
justifying the authorization of emergency use of in vitro diagnostics
for detection and/or diagnosis of the novel coronavirus (2019-nCoV).\1\
Rapid detection of COVID-19 cases in the United States requires wide
availability of SARS-CoV-2 testing. This guidance was originally
published on February 29, 2020, to describe a policy regarding
laboratories using tests they develop and validate before FDA has
issued an EUA for their test in order to achieve more rapid testing
capacity in the United States. The guidance was subsequently updated on
March 16, 2020, to include a policy enabling States to take
responsibility for oversight of laboratory developed tests within their
States, a policy for commercial manufacturers to more rapidly
distribute their SARS-CoV-2 diagnostic tests to laboratories for
specimen testing after validation while an EUA is being prepared for
submission to FDA, and a policy regarding the use of serological
testing without an EUA. The guidance was then updated on May 4, 2020,
to revise the policy regarding SARS-CoV-2 serology tests as it pertains
to commercial manufacturers. Among other things, the updated guidance
explained that commercial manufacturers should submit an EUA for their
distributed serology tests within 10 business days of notification to
FDA of validation or publication of the guidance published on May 4,
2020, whichever is later. The current version of the guidance was
posted on May 11, 2020.
---------------------------------------------------------------------------

    \1\ https://www.fda.gov/media/135010/download;.
---------------------------------------------------------------------------

    This guidance does not change the policies in the May 4, 2020,
guidance but includes a new section that references the availability,
on FDA's website, of templates for commercial manufacturers and
laboratories intended to facilitate EUA submissions for molecular,
antigen, and serology tests. The templates provide information and
recommendations, and FDA plans to update them as appropriate as we
learn more about the COVID-19 disease and gain experience with the EUA
process for the various types of COVID-19 tests.
    In the context of a public health emergency involving pandemic
infectious disease, it is critically important that tests are validated
because false results can have a broad public health impact beyond that
to the individual patient. In this guidance, FDA provides
recommendations regarding validation of COVID-19 tests, which remain
unchanged from the guidance published on May 4, 2020. FDA encourages
test developers to discuss any alternative approaches to validation
with FDA.
    In light of this public health emergency,\2\ FDA has determined
that prior public participation for this guidance is not feasible or
appropriate and is issuing this guidance without prior public comment
(see section 701(h)(1)(C)(i) of the Federal Food, Drug, and Cosmetic
Act (21 U.S.C. 371(h)(1)(C)(i)) and Sec.  10.115(g)(2)). Although this
guidance is immediately in effect, FDA will consider all comments
received and revise the guidance document as appropriate.
---------------------------------------------------------------------------

    \2\ Secretary of Health and Human Services Alex M. Azar,
Determination that a Public Health Emergency Exists. (January 31,
2020, renewed April 21, 2020), available at https://www.phe.gov/emergency/news/healthactions/phe/Pages/default.aspx.
---------------------------------------------------------------------------

    This guidance is being issued consistent with FDA's good guidance
practices regulation (Sec.  10.115). The guidance represents the
current thinking of FDA on ``Policy for Coronavirus Disease-2019 Tests
During the Public Health Emergency.'' It does not establish any rights
for any person and is not binding on FDA or the public. You can use an
alternative approach if it satisfies the requirements of the applicable
statutes and regulations.

III. Electronic Access

    Persons interested in obtaining a copy of the guidance may do so by
downloading an electronic copy from the internet. A search capability
for all Center for Devices and Radiological Health guidance documents
is available at https://www.fda.gov/medical-devices/device-advice-comprehensive-regulatory-assistance/guidance-documents-medical-devices-and-radiation-emitting-products. This guidance document is also
available at https://www.regulations.gov and at

https://www.fda.gov/emergency-preparedness-and-response/mcm-issues/covid-19-related-guidance-documents-industry-fda-staff-and-other-stakeholders. Persons unable to download an electronic copy of ``Policy
for Coronavirus Disease-2019 Tests During the Public Health Emergency;
Immediately in Effect Guidance for Clinical Laboratories, Commercial
Manufacturers, and Food and Drug Administration Staff '' may send an
email request to<EMAIL_ADDRESS>to receive an electronic
copy of the document. Please use the document number 20010-R3 and
complete title to identify the guidance you are requesting.

IV. Paperwork Reduction Act of 1995

    This guidance refers to previously approved collections of
information. These collections of information are subject to review by
the Office of Management and Budget (OMB) under the Paperwork Reduction
Act of 1995 (PRA) (44 U.S.C. 3501-3521). The collections of information
in the following FDA regulations and guidances have been approved by
OMB as listed in the below table. This guidance also contains a new
collection of information not approved under a current collection. This
new collection of information has been granted a public health
emergency (PHE) waiver from the PRA by the Department of HHS on March
19, 2020, under section 319(f) of the Public Health Services Act.
Information concerning the PHE PRA waiver can be found on the HHS
website at https://aspe.hhs.gov/public-health-emergency-declaration-pra-waivers.

----------------------------------------------------------------------------------------------------------------
                                         CFR cite         Another guidance                      New collection
     COVID-19  guidance title         referenced in        referenced in       OMB Control   covered by PHE  PRA
                                    COVID-19 guidance    COVID-19 guidance       No(s).             waiver
----------------------------------------------------------------------------------------------------------------
Policy for Coronavirus Disease-    ...................  Emergency Use             0910-0595  ...................
 2019 Tests During the Public                            Authorization of
 Health Emergency.                                       Medical Products
                                                         and Related
                                                         Authorities;
                                                         Guidance for
                                                         Industry and Other
                                                         Stakeholders.
                                                        Administrative            0910-0607
                                                         Procedures for
                                                         Clinical
                                                         Laboratory
                                                         Improvement
                                                         Amendments of 1988
                                                         Categorization.
                                                        De Novo                   0910-0844
                                                         Classification
                                                         Process
                                                         (Evaluation of
                                                         Automatic Class
                                                         III Designation).
                                   803                                            0910-0437
                                   807, subparts A                                0910-0625
                                    through D.
                                   807, subpart E.....                            0910-0120
                                   820................                            0910-0073
                                                                                Laboratory
                                                                                voluntary
                                                                                reporting to FDA
                                                                                of testing
                                                                                capacity
                                                                                information.
                                                                                Manufacturer
                                                                                voluntary
                                                                                reporting to FDA
                                                                                of testing
                                                                                capacity
                                                                                information and
                                                                                the number of
                                                                                laboratories in
                                                                                the U.S. with the
                                                                                required platforms
                                                                                installed.
                                                                                Laboratory
                                                                                voluntary
                                                                                reporting to FDA
                                                                                of validation
                                                                                data, when
                                                                                validating through
                                                                                a bridging study
                                                                                and not pursuing
                                                                                an EUA for the
                                                                                modification.
                                                                                State or territory
                                                                                voluntary
                                                                                notification to
                                                                                FDA of decision to
                                                                                authorize
                                                                                laboratories
                                                                                within that State
                                                                                or territory to
                                                                                develop and
                                                                                perform a test for
                                                                                COVID-19 under
                                                                                authority of its
                                                                                own State law.
                                                                                Laboratory
                                                                                voluntary
                                                                                notification to
                                                                                FDA that they have
                                                                                started clinical
                                                                                testing and
                                                                                voluntary
                                                                                reporting of
                                                                                testing capacity
                                                                                information, when
                                                                                the laboratory is
                                                                                authorized to
                                                                                develop and
                                                                                perform a test for
                                                                                COVID-19 under
                                                                                authority of a
                                                                                State or
                                                                                territory.
----------------------------------------------------------------------------------------------------------------

    Dated: May 12, 2020.
Lowell J. Schiller,
Principal Associate Commissioner for Policy.
[FR Doc. 2020-10492 Filed 5-14-20; 8:45 am]
BILLING CODE 4164-01-P


[Federal Register Volume 81, Number 13 (Thursday, January 21, 2016)]
[Proposed Rules]
[Pages 3344-3346]
[FR Doc No: 2016-00947]

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

DEPARTMENT OF TRANSPORTATION

Federal Aviation Administration

14 CFR Part 39

[Docket No. FAA-2016-0183; Directorate Identifier 2015-SW-016-AD]
RIN 2120-AA64

Airworthiness Directives; Kaman Aerospace Corporation

AGENCY: Federal Aviation Administration (FAA), DOT.

ACTION: Notice of proposed rulemaking (NPRM).

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

SUMMARY: We propose to adopt a new airworthiness directive (AD) for
Kaman Aerospace Corporation (Kaman) Model K-1200 helicopters. This
proposed AD would require revising the ``Flight Limitations--NO LOAD''
and ``Flight Limitations--LOAD'' sections of the rotorcraft flight
manual (RFM). This proposed AD is prompted by a report of certain
flight maneuvers that may lead to main rotor (M/R) blade to opposing
hub contact. The proposed actions are intended to prevent damage to the
M/R flight controls and subsequent loss of control of the helicopter.

DATES: We must receive comments on this proposed AD by March 21, 2016.

ADDRESSES: You may send comments by any of the following methods:
     Federal eRulemaking Docket: Go to http://www.regulations.gov. Follow the online instructions for sending your
comments electronically.
     Fax:<PHONE_NUMBER>.
     Mail: Send comments to the U.S. Department of
Transportation, Docket Operations, M-30, West Building Ground Floor,
Room W12-140, 1200 New Jersey Avenue SE., Washington, DC 20590-0001.
     Hand Delivery: Deliver to the ``Mail'' address between 9
a.m. and 5 p.m., Monday through Friday, except Federal holidays.

Examining the AD Docket

    You may examine the AD docket on the Internet at http://www.regulations.gov by searching for and locating Docket No. FAA-2016-
0183; or in person at the Docket Operations Office between 9 a.m. and 5
p.m., Monday through Friday, except Federal holidays. The AD docket
contains this proposed AD, the economic evaluation, any comments
received, and other information. The street address for the Docket
Operations Office (telephone<PHONE_NUMBER>) is in the ADDRESSES section.
Comments will be available in the AD docket shortly after receipt.
    For service information identified in this proposed rule, contact
Kaman Aerospace Corporation, Old Windsor Rd., P.O. Box 2, Bloomfield,
Connecticut 06002-0002; telephone<PHONE_NUMBER>; fax<PHONE_NUMBER>;
or at http://www.kamanaero.com. You may review the referenced service
information at the FAA, Office of the Regional Counsel, Southwest
Region, 10101 Hillwood Pkwy, Room 6N-321, Fort Worth, TX 76177.

FOR FURTHER INFORMATION CONTACT: Kirk Gustafson, Aviation Safety
Engineer, Boston Aircraft Certification Office, Engine & Propeller
Directorate, FAA, 12 New England Executive Park, Burlington,
Massachusetts 01803; telephone<PHONE_NUMBER>; email
<EMAIL_ADDRESS>
SUPPLEMENTARY INFORMATION:

Comments Invited

    We invite you to participate in this rulemaking by submitting
written comments, data, or views. We also invite comments relating to
the economic, environmental, energy, or federalism impacts that might
result from adopting the proposals in this document. The most helpful
comments reference a specific portion of the proposal, explain the
reason for any recommended change, and include supporting data. To
ensure the docket does not contain duplicate comments, commenters
should send only one copy of written comments, or if comments are filed
electronically, commenters should submit only one time.
    We will file in the docket all comments that we receive, as well as
a report summarizing each substantive public contact with FAA personnel
concerning this proposed rulemaking. Before acting on this proposal, we
will consider all comments we receive on or before the closing date for
comments. We will consider comments filed after the comment period has
closed if it is possible to do so without incurring expense or delay.
We may change this proposal in light of the comments we receive.

Discussion

    We propose to adopt a new AD for Kaman Model K-1200 helicopters.
This proposed AD would require revising the ``Flight Limitations--NO
LOAD'' and ``Flight Limitations--LOAD'' sections of the RFM by
inserting a warning and limitations about rearward to forward flight,
establishing maximum rearward and sideward flight speeds, and
prohibiting weather-vanning takeoffs and departures to turn the
helicopter. This proposed AD is prompted by a

report of a Model K1200 helicopter turning suddenly and causing blade
contact with the hub. The report suggests that a rapid aircraft yaw
rate and subsequent yaw arresting maneuver may cause low clearance of
the M/R blades with the opposing M/R hub. This condition could cause an
M/R blade to strike the opposing rotor's flight controls. The proposed
actions are intended to prevent damage to the M/R flight controls and
subsequent loss of control of the helicopter.

FAA's Determination

    We are proposing this AD because we evaluated all known relevant
information and determined that an unsafe condition exists and is
likely to exist or develop on other products of the same type design.

Related Service Information

    We reviewed Kaman K-1200 RFM, Revision 5, dated April 14, 2015.
This revision of the limitations section of the RFM inserts, for both
load operations and no load operations, a warning and limitations about
departing from rearward to forward flight, a maximum rearward flight
speed of 25 knots, a maximum sideward flight speed of 17 knots, and a
prohibition on weather-vanning takeoffs and departures as a method to
turn aircraft.

Proposed AD Requirements

    This proposed AD would require, within 10 hours time-in-service,
revising the Limitations section of the RFM by inserting a copy of this
AD or by making pen-and-ink changes. This proposed AD, under ``Flight
Limitations--NO LOAD'' and ``Flight Limitations--LOAD,'' would insert a
warning and limitations about departing from rearward to forward flight
to avoid high rates of turn and minimize yaw and cyclic control inputs,
establish a maximum rearward flight speed of 25 knots, establish a
maximum sideward flight speed of 17 knots, and prohibit weather-vanning
takeoffs and departures as a method to turn the helicopter.

Costs of Compliance

    We estimate that this proposed AD would affect 16 helicopters of
U.S. Registry. We estimate that operators may incur the following costs
in order to comply with this AD. At an average labor rate of $85 per
work-hour, we expect revising the RFM would require 0.5 work-hour, for
cost of about $43 per helicopter, or $688 for the U.S. fleet.

Authority for This Rulemaking

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

Regulatory Findings

    We determined that this proposed AD would not have federalism
implications under Executive Order 13132. This proposed AD would not
have a substantial direct effect on the States, on the relationship
between the national Government and the States, or on the distribution
of power and responsibilities among the various levels of government.
    For the reasons discussed, I certify this proposed regulation:
    1. Is not a ``significant regulatory action'' under Executive Order
12866;
    2. Is not a ``significant rule'' under the DOT Regulatory Policies
and Procedures (44 FR 11034, February 26, 1979);
    3. Will not affect intrastate aviation in Alaska to the extent that
it justifies making a regulatory distinction; and
    4. Will not have a significant economic impact, positive or
negative, on a substantial number of small entities under the criteria
of the Regulatory Flexibility Act.
    We prepared an economic evaluation of the estimated costs to comply
with this proposed AD and placed it in the AD docket.

List of Subjects in 14 CFR Part 39

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

The Proposed Amendment

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

PART 39--AIRWORTHINESS DIRECTIVES

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

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

Sec.  39.13  [Amended]

0
2. The FAA amends Sec.  39.13 by adding the following new airworthiness
directive (AD):

Kaman Aerospace Corporation (Kaman): Docket No. FAA-2016-0183;
Directorate Identifier 2015-SW-016-AD.

(a) Applicability

    This AD applies to Model K-1200 helicopters, certificated in any
category.

(b) Unsafe Condition

    This AD defines the unsafe condition as a main rotor (M/R) blade
striking the opposing rotor's flight controls. This condition could
result in damage to the M/R flight controls and subsequent loss of
control of the helicopter.

(c) Comments Due Date

    We must receive comments by March 21, 2016.

(d) Compliance

    You are responsible for performing each action required by this
AD within the specified compliance time unless it has already been
accomplished prior to that time.

(e) Required Actions

    Within 10 hours time-in-service, revise Section 2 Limitations of
the Kaman K-1200 Rotorcraft Flight Manual (RFM) by inserting a copy
of this AD into the RFM or by making pen-and-ink changes, as
follows:
    (1) In the ``Flight Limitations--NO LOAD'' and ``Flight
Limitations--WITH LOAD,'' sections, add the information in Figure 1
to paragraph (e)(1) of this AD.

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

-------------------------------------------------------------------------
                                 WARNING

When departing from rearward to forward flight, avoid high rates of turn
 and minimize yaw and cyclic control inputs to prevent exceeding 17 knot
 sideward flight limit.
------------------------------------------------------------------------
Figure 1 to paragraph (e)(1).

    (2) In the ``Flight Limitations--NO LOAD'' and ``Flight
Limitations--WITH LOAD'' sections, add the following: Maximum
rearward flight speed: 25 knots. Maximum sideward flight speed: 17
knots. Weather--

vanning takeoffs/departures as a method to turn aircraft:
Prohibited.

(f) Credit for Actions Previously Completed

    Incorporating the changes contained in Kaman K-1200 RFM,
Revision 5, dated April 14, 2015, before the effective date of this
AD is considered acceptable for compliance with the corresponding
actions specified in paragraph (e) of this AD.

(g) Alternative Methods of Compliance (AMOC)

    (1) The Manager, Boston Aircraft Certification Office, FAA, may
approve AMOCs for this AD. Send your proposal to: Kirk Gustafson,
Aviation Safety Engineer, Boston Aircraft Certification Office,
Engine & Propeller Directorate, FAA, 12 New England Executive Park,
Burlington, Massachusetts 01803; telephone<PHONE_NUMBER>; email
<EMAIL_ADDRESS>    (2) For operations conducted under a 14 CFR part 119 operating
certificate or under 14 CFR part 91, subpart K, we suggest that you
notify your principal inspector, or lacking a principal inspector,
the manager of the local flight standards district office or
certificate holding district office before operating any aircraft
complying with this AD through an AMOC.

 (h) Subject

    Joint Aircraft Service Component (JASC) Code: 6710, Main Rotor
Control.

    Issued in Fort Worth, Texas, on January 12, 2016.
Lance T. Gant,
Manager, Rotorcraft Directorate, Aircraft Certification Service.
[FR Doc. 2016-00947 Filed 1-20-16; 8:45 am]
 BILLING CODE 4910-13-P


[Federal Register Volume 82, Number 24 (Tuesday, February 7, 2017)]
[Notices]
[Pages 9628-9629]
[FR Doc No: 2017-02459]

=======================================================================
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DEPARTMENT OF TRANSPORTATION

Federal Aviation Administration

Twentieth Meeting of the NextGen Advisory Committee (NAC)

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

ACTION: Twentieth Meeting of the NextGen Advisory Committee (NAC).

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

SUMMARY: The FAA is issuing this notice to advise the public of a
meeting of the Twentieth Meeting of the NextGen Advisory Committee
(NAC).

DATES: The meeting will be held February 22, 2017, 8:30 a.m.-3 p.m.

ADDRESSES: The meeting will be held at: The MITRE Corporation, MITRE 1
Auditorium, 7525 Colshire Drive, McLean, VA 22102.

FOR FURTHER INFORMATION CONTACT: Andy Cebula, NAC Secretariat, 202-330-
0652, acebula@rtca.org,1150 18th Street NW., Suite 910, Washington, DC
20036, or by fax at<PHONE_NUMBER>, or Web site at http://www.rtca.org.

SUPPLEMENTARY INFORMATION: Pursuant to section 10(a)(2) of the Federal
Advisory Committee Act (Pub. L. 92-463, 5 U.S.C., App.), notice is
hereby given for a meeting of the Twentieth Meeting of the NextGen
Advisory Committee (NAC). The agenda will include the following:

February 22, 2017, 8:30 a.m. to 3:00 p.m.

1. Opening of Meeting/Introduction of NAC Members--Chairman David
Bronczek
2. Official Statement of Designated Federal Official--Victoria Wassmer,
FAA Acting Deputy Administrator
3. Review and Approval of October 5, 2016 Meeting Summary and Revised
Terms of Reference
4. Chairman's Report--Chairman Bronczek
5. FAA Report--FAA
6. NextGen Priorities Status: DataComm, Multiple Runway Operations,
Surface, Performance Based Navigation (PBN)
7. Airline C/N/S Fleet Plans--Alaska Air, UPS; Supply Chain--Honeywell;
ADS-B Update--FAA
8. FAA NextGen Plan
9. Value of NextGen and NAC Ad Hoc
10. Joint Analysis Team--Indianapolis International Airport (IND) Wake
ReCat
11. Enhanced Surveillance Task Group--Interim Report
12. Summary of meeting and next steps
13. Closing Comments--DFO and NAC Chairman
14. Other business
15. Adjourn

Although the NAC meeting is open to the public, the meeting location
has limited space and security protocols that require advanced
registration.
    U.S. Nationals: Please email<EMAIL_ADDRESS>with name, state-issued
driver's license/ID number and state of issuance, company, and phone
number contact to pre-register no later than February 13, 2017.
    Foreign Nationals: Please email<EMAIL_ADDRESS>with name, company
and country of citizenship, birth date and place of birth (city and
country), passport and Visa Numbers, I-94 stamp and expiration date,
employer and address (identify whether U.S. or non-U.S. owned), and
phone number contact to pre-register no later than February 13, 2017.
    With the approval of the Chairman, members of the public may
present oral statements at the meeting. Persons wishing to present
statements or obtain information should contact the person listed in
the FOR FURTHER INFORMATION CONTACT section. Members of the public may
present a written statement to the committee at any time.

    Issued in Washington, DC, on February 2, 2017.
Mohannad Dawoud,
Management & Program Analyst, Partnership Contracts Branch, ANG-A17,
NextGen, Procurement Services Division, Federal Aviation
Administration.
[FR Doc. 2017-02459 Filed 2-6-17; 8:45 am]
BILLING CODE 4910-13-P


[Federal Register Volume 82, Number 231 (Monday, December 4, 2017)]
[Notices]
[Pages 57250-57251]
[FR Doc No: 2017-26036]

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DEPARTMENT OF ENERGY

Federal Energy Regulatory Commission

[Project No. 10822-013]

Town of Canton, Connecticut; Notice of Application for License
Reinstatement, Amendment, Transfer, Extension of License Term, and
Soliciting Comments, Motions To Intervene, Protests, Recommendations,
Terms and Conditions, and Fishway Prescriptions

    Take notice that the following hydroelectric application has been
filed with the Commission and is available for public inspection.
    a. Type of Application: Reinstatement, Amendment, and Transfer.
    b. Project No.: 10822-013.
    c. Date filed: October 12, 2017.
    d. Applicant: Town of Canton, Connecticut.
    e. Name of Project: Upper Collinsville Project.
    f. Location: On the Farmington River near the village of
Collinsville in Hartford County, Connecticut.
    g. Filed Pursuant to: Federal Power Act 16 U.S.C. 791(a)-825(r) and
Public Law 113-122.
    h. Applicant Contact: Robert Skinner, Chief Administrative Officer,
Town of Canton, Connecticut, P.O. Box 168, 4 Market Street,
Collinsville, CT,<PHONE_NUMBER> or [email protected].
    i. FERC Contact: Diana Shannon,<PHONE_NUMBER> or
[email protected].
    j. Deadline for filing motions to intervene and protests, comments,
recommendations, terms and conditions, and fishway prescriptions is 60
days from the issuance date of this notice by the Commission; reply
comments are due 105 days from the issuance date of this notice by the
Commission. The Commission strongly encourages electronic filing.
    Please file any motion to intervene, protest, comments, and/or
recommendations using the Commission's eFiling system at http://www.ferc.gov/docs-filing/efiling.asp. Commenters can submit brief
comments up to 6,000 characters, without prior registration, using the
eComment system at http://www.ferc.gov/docs-filing/ecomment.asp. You
must include your name and contact information at the end of your
comments. For assistance, please contact FERC Online Support at
[email protected],<PHONE_NUMBER> (toll free), or (202) 502-
8659 (TTY). In lieu of electronic filing, please send a paper copy to:
Secretary, Federal Energy Regulatory Commission, 888 First Street NE.,
Washington, DC 20426. The first page of any filing should include
docket number P-10822-013.
    k. Description of Request: On October 12, 2017, the Town of Canton,
Connecticut, filed a request to reinstate, amend, and transfer the
license for the Upper Collinsville Project No. 10822. The project was
previously licensed to Summit Hydropower, but the license was
terminated by Commission order dated December 4, 2007, for failure to
start construction pursuant to Article 301 of the license and section
13 of the Federal Power Act. By Public Law 113-122, dated June 30,
2014, Congress approved the Collinsville Renewable Energy Production
Act, which at the request of the Town of Canton, and after reasonable
notice, allows the Commission to: (1) Reinstate the license; (2) extend
for two years after the date on which the license is reinstated the
time period during which the licensee is required to commence
construction of the project; and (3) allows the license to be
transferred to the town of Canton. The Town of Canton proposes to
rehabilitate the project, provide upstream and downstream fish and eel
passage, and provide additional environmental measures, including water
quality monitoring, mussel relocation, and recreation. The Town
requests the Commission to reinstate the license with a new term of 40-
50 years.
    l. Locations of the Application: A copy of the application is
available for inspection and reproduction at the Commission's Public
Reference Room, located at 888 First Street NE., Room 2A, Washington,
DC 20426, or by calling<PHONE_NUMBER>. This filing may also be viewed
on the Commission's Web site at http://www.ferc.gov/docs-filing/efiling.asp. Enter the docket number excluding the last three digits in
the docket number field to access the document. You may also register
online at http://www.ferc.gov/docs-filing/esubscription.asp to be
notified via email of new filings and issuances related to this or
other pending projects. For assistance, call 1-866-208-3676 or email
[email protected], for TTY, call<PHONE_NUMBER>. A copy is
also available for inspection and reproduction at the addresses in item
(h) above.
    m. Individuals desiring to be included on the Commission's mailing
list should so indicate by writing to the Secretary of the Commission.
    n. Comments, Protests, or Motions to Intervene: Anyone may submit
comments, a protest, or a motion to intervene in accordance with the
requirements of Rules of Practice and Procedure, 18 CFR 385.210, .211,
and .214. In determining the appropriate action to take, the Commission
will consider all protests or other comments filed, but only those who
file a motion to intervene in accordance with the Commission's Rules
may become a party to the proceeding. Any comments, protests, or
motions to intervene must be received on or before the specified
comment date for the particular application.
    o. Filing and Service of Documents: Any filing must (1) bear in all
capital letters the title COMMENTS, PROTEST, or MOTION TO INTERVENE as
applicable; (2) set forth in the heading the name of the applicant and
the project number of the application to which the filing responds; (3)
furnish the name, address, and telephone number of the person
protesting or intervening; and (4) otherwise comply with the
requirements of 18 CFR 385.2001 through 385.2005. All comments, motions
to intervene, or protests must set forth their evidentiary basis and
otherwise comply with the requirements of 18 CFR 4.34(b). Agencies may
obtain copies of the application directly from the applicant. A copy of
any protest or motion to intervene must be served upon each
representative of the applicant specified in the particular
application. If an intervenor files comments or documents with the
Commission relating to the merits of an issue that may affect the
responsibilities of a particular resource

agency, they must also serve a copy of the document on that resource
agency. A copy of all other filings in reference to this application
must be accompanied by proof of service on all persons listed in the
service list prepared by the Commission in this proceeding, in
accordance with 18 CFR 4.34(b) and 385.2010.

    Dated: November 28, 2017.
Kimberly D. Bose,
Secretary.
[FR Doc. 2017-26036 Filed 12-1-17; 8:45 am]
BILLING CODE 6717-01-P