[Federal Register Volume 79, Number 7 (Friday, January 10, 2014)]
[Notices]
[Pages 1873-1874]
[FR Doc No: 2014-00259]

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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2013-D-1630]

Draft Guidance for Industry on Qualification of Exacerbations of
Chronic Pulmonary Disease Tool for Measurement of Symptoms of Acute
Bacterial Exacerbation of Chronic Bronchitis in Patients With Chronic
Obstructive Pulmonary Disease; Availability

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice.

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SUMMARY: The Food and Drug Administration (FDA) is announcing the
availability of a draft guidance for industry entitled ``Qualification
of Exacerbations of Chronic Pulmonary Disease Tool for Measurement of
Symptoms of Acute Bacterial Exacerbation of Chronic Bronchitis in
Patients with Chronic Obstructive Pulmonary Disease.'' This draft
guidance provides a statement of qualification for the Exacerbations of
Chronic Pulmonary Disease Tool (EXACT) patient-reported outcome
instrument and summarizes the concept of interest and context of use
(COU) for which the tool is qualified through the Center for Drug
Evaluation and Research's (CDER's) drug development tool (DDT)
qualification program. Qualification of the EXACT represents a
conclusion that, within the stated COU, the instrument can be relied on
to have a specific interpretation and application in drug development
and regulatory review. This draft guidance is an attachment to the
guidance for industry entitled ``Qualification Process for Drug
Development Tools.''

DATES: Although you can comment on any guidance at any time (see 21 CFR
10.115(g)(5)), to ensure that the Agency

considers your comment on this draft guidance before it begins work on
the final version of the guidance, submit either electronic or written
comments on the draft guidance by April 10, 2014.

ADDRESSES: Submit written requests for single copies of the draft
guidance to the Division of Drug Information, Center for Drug
Evaluation and Research, Food and Drug Administration, 10903 New
Hampshire Ave., Bldg. 51, Rm. 2201, Silver Spring, MD 20993-0002. Send
one self-addressed adhesive label to assist that office in processing
your requests. See the SUPPLEMENTARY INFORMATION section for electronic
access to the draft guidance document.
    Submit electronic comments on the draft guidance to http://www.regulations.gov. Submit written comments to the Division of Dockets
Management (HFA-305), Food and Drug Administration, 5630 Fishers Lane,
Rm. 1061, Rockville, MD 20852.

FOR FURTHER INFORMATION CONTACT: Elektra J. Papadopoulos, Center for
Drug Evaluation and Research, Food and Drug Administration, 10903 New
Hampshire Ave., Bldg. 22, Rm. 6429, Silver Spring, MD 20993-0002, 301-
796-0900.

SUPPLEMENTARY INFORMATION:

I. Background

    FDA is announcing the availability of a draft guidance for industry
entitled ``Qualification of Exacerbations of Chronic Pulmonary Disease
Tool for Measurement of Symptoms of Acute Bacterial Exacerbation of
Chronic Bronchitis in Patients with Chronic Obstructive Pulmonary
Disease.''
    In March 2006, FDA issued the ``Critical Path Opportunities Report
and List'', in which FDA described six key areas along the critical
path to improved therapies and listed specific opportunities for
advancement within these topic areas. The report noted that a new
product development toolkit containing new scientific and technical
methods was needed to improve the efficiency of drug development.
    Innovative and improved DDTs can help streamline the drug
development process, improve the chances for clinical trial success,
and yield more information about a treatment and/or disease. DDTs
include, but are not limited to, biomarkers and clinical outcome
assessments (COAs). CDER has developed a formal process, the DDT
qualification process, to work with developers of these tools to guide
them as they refine the tools and rigorously evaluate them for use in
the regulatory context. Once qualified, DDTs will be publicly available
for use in any drug development program for the qualified COU. COA DDTs
are developed and reviewed using this process when they are intended
ultimately for use as primary or secondary endpoints in clinical trials
designed to provide substantial evidence of treatment benefit. Upon
qualification by CDER, a qualification statement is provided describing
the concept of interest and COU for which the tool is qualified. This
draft guidance describes the qualification statement for the EXACT, a
COA DDT.
    This draft guidance is being issued consistent with FDA's good
guidance practices regulation (21 CFR 10.115). The draft guidance, when
finalized, will represent the Agency's current thinking on the
qualification of the EXACT COA DDT. It does not create or confer any
rights for or on any person and does not operate to bind FDA or the
public. An alternative approach may be used if such approach satisfies
the requirements of the applicable statutes and regulations.

II. Comments

    Interested persons may submit either electronic comments regarding
this document to http://www.regulations.gov or written comments to the
Division of Dockets Management (see ADDRESSES). It is only necessary to
send one set of comments. Identify comments with the docket number
found in brackets in the heading of this document. Received comments
may be seen in the Division of Dockets Management between 9 a.m. and 4
p.m., Monday through Friday, and will be posted to the docket at http://www.regulations.gov.

III. Electronic Access

    Persons with access to the Internet may obtain the document at
either http://www.fda.gov/Drugs/GuidanceComplianceRegulatoryInformation/Guidances/default.htm or http://www.regulations.gov.

    Dated: January 6, 2014.
Leslie Kux,
Assistant Commissioner for Policy.
[FR Doc. 2014-00259 Filed 1-9-14; 8:45 am]
BILLING CODE 4160-01-P


calendar year, the quantity of natural gas produced that is sent to
sale in the calendar year, in thousand standard cubic feet.
    (v) For each well permanently shut-in and plugged during the
calendar year, the quantity of crude oil produced that is sent to sale
in the calendar year, in barrels.
    (vi) For each well permanently shut-in and plugged during the
calendar year, the quantity of condensate produced that is sent to sale
in the calendar year, in barrels.
    (3) For natural gas processing, if your facility fractionates NGLs
and also reports as a supplier to subpart NN of this part, you must
report the information specified in paragraphs (aa)(3)(ii) and
(aa)(3)(v) through (ix) of this section. Otherwise, report the
information specified in paragraphs (aa)(3)(i) through (ix) of this
section.
    (i) The quantity of natural gas received at the gas processing
plant for processing in the calendar year, in thousand standard cubic
feet.
* * * * *
    (viii) Indicate whether the facility reports as a supplier to
subpart NN of this part.
    (ix) The quantity of residue gas leaving that has been processed by
the facility and any gas that passes through the facility to sales
without being processed by the facility.
    (4) * * *
    (i) The quantity of natural gas transported through the compressor
station in the calendar year, in thousand standard cubic feet.
* * * * *
    (5) * * *
    (ii) The quantity of natural gas withdrawn from storage and sent to
sale in the calendar year, in thousand standard cubic feet.
* * * * *
    (6) For LNG import equipment, report the quantity of LNG imported
that is sent to sale in the calendar year, in thousand standard cubic
feet.
    (7) For LNG export equipment, report the quantity of LNG exported
that is sent to sale in the calendar year, in thousand standard cubic
feet.
    (8) * * *
    (ii) The quantity of LNG withdrawn from storage and sent to sale in
the calendar year, in thousand standard cubic feet.
* * * * *
    (10) For onshore petroleum and natural gas gathering and boosting
facilities, report the quantities specified in paragraphs (aa)(10)(i)
through (v) of this section.
* * * * *
    (ii) The quantity of natural gas transported through the facility
to a downstream endpoint such as a natural gas processing facility, a
natural gas transmission pipeline, a natural gas distribution pipeline,
a storage facility, or another gathering and boosting facility in the
calendar year, in thousand standard cubic feet.
* * * * *
    (iv) The quantity of all hydrocarbon liquids transported to a
downstream endpoint such as a natural gas processing facility, a
natural gas transmission pipeline, a natural gas distribution pipeline,
a storage facility, or another gathering and boosting facility in the
calendar year, in barrels.
    (v) Report the information specified in paragraphs (aa)(10)(v)(A)
through (E) of this section for each gathering and boosting site
located in the facility.
    (A) A unique name or ID number for the gathering and boosting site.
    (B) Gathering and boosting site type (gathering compressor station,
centralized oil production site, gathering pipeline, or other fence-
line site).
    (C) State.
    (D) For gathering compressor stations, centralized oil production
sites, and other fence-line sites, county.
    (E) For gathering compressor stations, centralized oil production
sites, and other fence-line sites, the latitude and longitude of the
gathering and boosting site representing the geographic centroid or
center point of the site in decimal degrees to at least four digits to
the right of the decimal point.
    (11) * * *
    (ii) The quantity of natural gas withdrawn from underground natural
gas storage and LNG storage (regasification) facilities owned and
operated by the onshore natural gas transmission pipeline owner or
operator that are not subject to this subpart in the calendar year, in
thousand standard cubic feet.
    (iii) The quantity of natural gas added to underground natural gas
storage and LNG storage (liquefied) facilities owned and operated by
the onshore natural gas transmission pipeline owner or operator that
are not subject to this subpart in the calendar year, in thousand
standard cubic feet.
    (iv) The quantity of natural gas transported through the facility
and transferred to third parties such as LDCs or other transmission
pipelines, in thousand standard cubic feet.
* * * * *
    (bb) Missing data. For any missing data procedures used, report the
information in Sec.  98.3(c)(8) and the procedures used to substitute
an unavailable value of a parameter, except as provided in paragraphs
(bb)(1) and (2) of this section.
* * * * *
    (cc) Delay in reporting for wildcat wells and delineation wells. If
you elect to delay reporting the information in paragraph (g)(5)(i) or
(ii), (g)(5)(iii)(A) or (B), (h)(1)(iv), (h)(2)(iv), (j)(1)(iii),
(j)(2)(i)(A), (l)(1)(v), (l)(2)(v), (l)(3)(iv), (l)(4)(iv), or (m)(5)
or (6) of this section, you must report the information required in
that paragraph no later than the date 2 years following the date
specified in Sec.  98.3(b) introductory text.
    (dd) Drilling mud degassing. You must indicate whether there were
mud degassing operations at your facility, and if so, which methods (as
specified in Sec.  98.233(dd)) were used to calculate emissions. For
wells for which your facility performed mud degassing operations and
used Calculation Method 1, then you must report the information
specified in paragraph (dd)(1) of this section. For wells for which
your facility performed mud degassing operations and used Calculation
Method 2, then you must report the information specified in paragraph
(dd)(2) of this section.
    (1) For each well for which you used Calculation Method 1 to
calculate natural gas emissions from mud degassing, report the
information specified in paragraphs (dd)(1)(i) through (vii) of this
section.
    (i) Well ID number.
    (ii) Approximate total depth below surface, in feet.
    (iii) Total time that drilling mud is circulated in the well, in
minutes.
    (iv) The composition of the drilling mud: water-based, oil-based,
or synthetic.
    (v) If the well is not a representative well, Well ID number of the
representative well used to derive the CH4 emission rate
used to calculate CH4 emissions for this well.
    (vi) If the well is a representative well, report the information
specified in paragraphs (dd)(1)(vi)(A) through (D) of this section.
    (A) Average mud rate, in gallons per minute.
    (B) Concentration of natural gas in the drilling mud (Xn
in Equation W-41), in parts per million.

    (C) Measured mole fraction for CH4 in natural gas
entrained in the drilling mud (GHGCH4 in Equation W-41).
    (D) Calculated CH4 emissions rate in standard cubic per
minute (ERs,CH4,r in Equation W-42).
    (vii) Annual CH4 emissions, in metric tons
CH4, from well drilling mud degassing, calculated according
to Sec.  98.233(dd)(1).
    (2) For each well for which you used Calculation Method 2 to
calculate natural gas emissions from mud degassing, report the
information specified in paragraphs (dd)(2)(i) through (iv) of this
section.
    (i) Well ID number.
    (ii) Total number of drilling days.
    (iii) The composition of the drilling mud: water-based, oil-based,
or synthetic.
    (iv) Annual CH4 emissions, in metric tons
CH4, from drilling mud degassing, calculated according to
Sec.  98.233(dd)(2).
    (ee) Crankcase vents. You must indicate whether your facility
performs any crankcase venting from reciprocating internal combustion
engines or gas turbines. If your facility contains at least one
crankcase vent on an applicable engine, you must report the information
specified in paragraphs (ee)(1) through (4) of this section for each
well-pad (for onshore petroleum and natural gas production), gathering
and boosting site (for onshore petroleum and natural gas gathering and
boosting), or facility (for all other applicable industry segments).
    (1) Well-pad ID (for the onshore petroleum and natural gas
production industry segment only) or gathering and boosting site ID
(for the onshore petroleum and natural gas gathering and boosting
industry segment only).
    (2) Total number of crankcase vents at the well-pad, gathering and
boosting site, or facility, as applicable (``Count'' in Equation W-45
of this subpart).
    (3) Average estimated time that the reciprocating internal
combustion engines or gas turbines with crankcase venting were
operational in the calendar year, in hours (``T'' in Equation W-45 of
this subpart).
    (4) Annual CH4 emissions, in metric tons CH4,
calculated according to Sec.  98.233(ee)(1).
0
16. Amend Sec.  98.238 by:
0
a. Removing the definition for ``Acid gas removal vent emissions'' and
adding the definition for ``Acid gas removal unit (AGR) vent
emissions'' in alphabetical order;
0
b. Adding definitions for ``Atmospheric pressure storage tank,''
``Automated liquids unloading,'' and ``Centralized oil production
site'' in alphabetical order;
0
c. Revising the definitions for ``Compressor mode'' and ``Compressor
source'';
0
d. Adding definitions for ``Crankcase venting,'' ``Drilling mud,'' and
``Drilling mud degassing'' in alphabetical order;
0
e. Removing the second definition for ``Facility with respect to
natural gas distribution for purposes of reporting under this subpart
and for the corresponding subpart A requirements'';
0
f. Revising the definitions for ``Flare stack emissions'' and ``Forced
extraction of natural gas liquids'';
0
g. Adding the definition for ``Gathering and boosting site'' in
alphabetical order;
0
h. Revising the definitions for ``Gathering and boosting system'' and
``Gathering and boosting system owner or operator''; and
0
i. Adding definitions for ``Gathering compressor station,'' ``Gathering
pipeline site,'' ``In vacuum service,'' ``Manual liquids unloading,''
``Mud rate,'' ``Nitrogen removal unit (NRU),'' ``Nitrogen removal unit
vent emissions,'' ``Other large release event,'' ``Produced water,''
``Routed to combustion,'' ``Well blowout,'' and ``Well release'' in
alphabetical order.
    The additions and revisions read as follows:

Sec.  98.238  Definitions.

* * * * *
    Acid gas removal unit (AGR) vent emissions mean the acid gas
separated from the acid gas absorbing medium (e.g., an amine solution)
and released with methane and other light hydrocarbons to the
atmosphere or a flare.
* * * * *
    Atmospheric pressure storage tank means a vessel (excluding sumps)
operating at atmospheric pressure that is designed to contain an
accumulation of crude oil, condensate, intermediate hydrocarbon
liquids, or produced water and that is constructed entirely of non-
earthen materials (e.g., wood, concrete, steel, plastic) that provide
structural support. Atmospheric pressure storage tanks include both
fixed roof tanks and floating roof tanks. Floating roof tanks include
tanks with either an internal floating roof or an external floating
roof.
    Automated liquids unloading means an unloading that is performed
without manual interference. Examples of automated liquids unloadings
include a timing and/or pressure device used to optimize intermittent
shut-in of the well before liquids choke off gas flow or to open and
close valves, continually operating equipment that does not require
presence of an operator such as rod pumping units, automated and
unmanned plunger lifts, or other unloading activities that do not
entail a physical presence at the well-pad.
* * * * *
    Centralized oil production site means any permanent combination of
one or more hydrocarbon liquids storage tanks located on one or more
contiguous or adjacent properties that does not also contain a
permanent combination of one or more compressors that are part of the
onshore petroleum and natural gas gathering and boosting facility that
gathers hydrocarbon liquids from multiple well-pads. A centralized oil
production site is a type of gathering and boosting site for purposes
of reporting under Sec.  98.236.
* * * * *
    Compressor mode means the operational and pressurized status of a
compressor. For both centrifugal compressors and reciprocating
compressors, ``mode'' refers to either: Operating-mode, standby-
pressurized-mode, or not-operating-depressurized-mode.
    Compressor source means the source of certain venting or leaking
emissions from a centrifugal or reciprocating compressor. For
centrifugal compressors, ``source'' refers to blowdown valve leakage
through the blowdown vent, unit isolation valve leakage through an open
blowdown vent without blind flanges, wet seal oil degassing vents, and
dry seal vents. For reciprocating compressors, ``source'' refers to
blowdown valve leakage through the blowdown vent, unit isolation valve
leakage through an open blowdown vent without blind flanges, and rod
packing emissions.
* * * * *
    Crankcase venting means the process of venting or removing blow-by
from the void spaces of an internal combustion engine outside of the
combustion cylinders to prevent excessive pressure build-up within the
engine. This does not include ingestive systems that vent blow-by into
the engine where it is returned to the combustion process.
* * * * *
    Drilling mud means a mixture of clays and additives with water,
oil, or synthetic materials. While drilling, the drilling mud is
continuously pumped through the drill string and out the bit to cool
and lubricate the drill bit, and move cuttings through the wellbore to
the surface.
    Drilling mud degassing means the practice of safely removing
pockets of free gas entrained in the drilling mud once it is outside of
the wellbore.
* * * * *

    Flare stack emissions means CO2 in gas routed to a
flare, CO2 from partial combustion of hydrocarbons in gas
routed to a flare, CH4 emissions resulting from the
incomplete combustion of hydrocarbons in gas routed to a flare, and
N2O resulting from operation of a flare.
    Forced extraction of natural gas liquids means removal of ethane or
higher carbon number hydrocarbons existing in the vapor phase in
natural gas, by removing ethane or heavier hydrocarbons derived from
natural gas into natural gas liquids by means of a forced extraction
process. Forced extraction processes include but are not limited to
refrigeration, absorption (lean oil), cryogenic expander, and
combinations of these processes. Forced extraction does not include in
and of itself; natural gas dehydration, the collection or gravity
separation of water or hydrocarbon liquids from natural gas at ambient
temperature or heated above ambient temperatures, the condensation of
water or hydrocarbon liquids through passive reduction in pressure or
temperature, a Joule-Thomson valve, a dew point depression valve, or an
isolated or standalone Joule-Thomson skid.
    Gathering and boosting site means a single gathering compressor
station as defined in this section, centralized oil production site as
defined in this section, gathering pipeline site as defined in this
section, or other fence-line site within the onshore petroleum and
natural gas gathering and boosting industry segment.
    Gathering and boosting system means a single network of pipelines,
compressors and process equipment, including equipment to perform
natural gas compression, dehydration, and acid gas removal, that has
one or more connection points to gas and oil production or one or more
other gathering and boosting systems and a downstream endpoint,
typically a gas processing plant, transmission pipeline, LDC pipeline,
or other gathering and boosting system.
    Gathering and boosting system owner or operator means any person
that holds a contract in which they agree to transport petroleum or
natural gas from one or more onshore petroleum and natural gas
production wells or one or more other gathering and boosting systems to
a natural gas processing facility, another gathering and boosting
system, a natural gas transmission pipeline, or a distribution
pipeline, or any person responsible for custody of the petroleum or
natural gas transported.
    Gathering compressor station means any permanent combination of one
or more compressors located on one or more contiguous or adjacent
properties that are part of the onshore petroleum and natural gas
gathering and boosting facility that move natural gas at increased
pressure through gathering pipelines or into or out of storage. A
gathering compressor station is a type of gathering and boosting site
for purposes of reporting under Sec.  98.236.
    Gathering pipeline site means all of the gathering pipelines within
a single state. A gathering pipeline site is a type of gathering and
boosting site for purposes of reporting under Sec.  98.236.
* * * * *
    In vacuum service means equipment operating at an internal pressure
which is at least 5 kilopascals (kPa) (0.7 psia) below ambient
pressure.
* * * * *
    Manual liquids unloading means an unloading when field personnel
attend to the well at the well-pad, for example to manually plunge a
well at the site using a rig or other method, to open a valve to direct
flow to an atmospheric tank to clear the well, or to manually shut-in
the well to allow pressure to build in the well-bore. Manual unloadings
may be performed on a routine schedule or on ``as needed'' basis.
* * * * *
    Mud rate means the pumping rate of the mud by the mud pumps,
usually measured in gallons per minute (gpm).
* * * * *
    Nitrogen removal unit (NRU) means a process unit that separates
nitrogen from natural gas using various separation processes (e.g.,
cryogenic units, membrane units, etc.)
    Nitrogen removal unit vent emissions means the nitrogen gas
separated from the natural gas and released with methane and other
gases to the atmosphere, flare, or other combustion unit.
* * * * *
    Other large release event means any planned or unplanned
uncontrolled release to the atmosphere of gas, liquids, or mixture
thereof, from wells and/or other equipment that result in emissions for
which there are no methodologies in Sec.  98.233 other than under Sec.
98.233(y) to appropriately estimate these emissions. Other large
release events include, but are not limited to, well blowouts, well
releases, pressure relief valve releases from process equipment other
than hydrocarbon liquids storage tanks, storage tank cleaning and other
maintenance activities, and releases that occur as a result of an
accident, equipment rupture, fire, or explosion. Other large release
events also include failure of equipment or equipment components such
that a single equipment leak or release has emissions that exceed the
emissions calculated for that source using applicable methods in Sec.
98.233(a) through (s), (w), (x), (dd), or (ee) by the threshold in
Sec.  98.233(y)(1)(ii).
* * * * *
    Produced water means the water (brine) brought up from the
hydrocarbon-bearing strata during the extraction of oil and gas, and
can include formation water, injection water, and any chemicals added
downhole or during the oil/water separation process.
* * * * *
    Routed to combustion means, for onshore petroleum and natural gas
production facilities, natural gas distribution facilities, and onshore
petroleum and natural gas gathering and boosting facilities, that
emissions are routed to stationary or portable fuel combustion
equipment specified in Sec.  98.232(c)(22), (i)(7), or (j)(12), as
applicable. For all other industry segments in this subpart, routed to
combustion means that emissions are routed to a stationary fuel
combustion unit subject to subpart C of this part (General Stationary
Fuel Combustion Sources).
* * * * *
    Well blowout means a complete loss of well control for a long
duration of time resulting in an emissions release.
* * * * *
    Well release means a short duration of uncontrolled emissions
release from a well followed by a period of controlled emissions
release in which control techniques were successfully implemented.
* * * * *
    17. Remove table W-1A, table W-1B, table W-1C, table W-1D, and
table W-1E to subpart W of part 98 and add table W-1 to subpart W of
part 98 in numerical order to read as follows:

Table W-1 to Subpart W of Part 98--Default Whole Gas Population Emission
                                 Factors
------------------------------------------------------------------------
                                                        Emission factor
       Industry segment         Source type/component   (scf whole gas/
                                                           hour/unit)
------------------------------------------------------------------------
Population Emission Factors--Pneumatic Device Vents and Pneumatic Pumps,
                              Gas Service 1
------------------------------------------------------------------------
 Onshore petroleum and  Continuous Low Bleed                 6.8
 natural gas production.         Pneumatic Device                     21
 Onshore petroleum and   Vents 2.
 natural gas gathering and      Continuous High Bleed
 boosting.                       Pneumatic Device
                                 Vents 2.
                                Pneumatic Pumps 3....               13.3
 Onshore natural gas    Continuous Low Bleed                 6.8
 processing.                     Pneumatic Device
                                 Vents 2.
 Onshore natural gas    Continuous High Bleed                 30
 transmission compression.       Pneumatic Device
                                 Vents 2.
 Underground natural
 gas storage.
 Natural gas
 distribution.
------------------------------------------------------------------------
       Population Emission Factors--Major Equipment, Gas Service 1
------------------------------------------------------------------------
 Onshore petroleum and  Wellhead.............               8.87
 natural gas production.        Separator............               9.65
 Onshore petroleum and  Meters/Piping........               7.04
 natural gas gathering and      Compressor...........               13.8
 boosting.
                                Dehydrator...........               8.09
                                Heater...............               5.22
                                Storage Vessel.......               1.83
------------------------------------------------------------------------
       Population Emission Factors--Major Equipment, Crude Service
------------------------------------------------------------------------
Onshore petroleum and natural   Wellhead.............               4.13
 gas production.                Separator............               4.77
                                Meters/Piping........               12.4
                                Compressor...........               13.8
                                Dehydrator...........               8.09
                                Heater...............                3.2
                                Storage Vessel.......               1.91
------------------------------------------------------------------------
  Population Emission Factors--Gathering Pipelines, by Material Type 4
------------------------------------------------------------------------
Onshore petroleum and natural   Protected Steel......               0.93
 gas gathering and boosting.    Unprotected Steel....                8.2
                                Plastic/Composite....               0.28
                                Cast Iron............                8.4
------------------------------------------------------------------------
\1\ For multi-phase flow that includes gas, use the gas service emission
  factors.
\2\ Emission factor is in units of ``scf whole gas/hour/device.''
\3\ Emission factor is in units of ``scf whole gas/hour/pump.''
\4\ Emission factors are in units of ``scf whole gas/hour/mile of
  pipeline.''

0
18. Revise table W-2 to subpart W of part 98 to read as follows:

                  Table W-2 to Subpart W of Part 98--Default Whole Gas Leaker Emission Factors
----------------------------------------------------------------------------------------------------------------
                                                     Emission factor (scf whole gas/hour/component)
                                      --------------------------------------------------------------------------
                                         If you survey using      If you survey using    If you survey using any
         Equipment components           Method 21 as specified   Method 21 as specified   of the methods in Sec.
                                               in Sec.                  in Sec.            98.234(a)(1), (3), or
                                           98.234(a)(2)(i)          98.234(a)(2)(ii)               (5)
----------------------------------------------------------------------------------------------------------------
   Leaker Emission Factors--Onshore Petroleum and Natural Gas Production and Onshore Petroleum and Natural Gas
                              Gathering and Boosting--All Components, Gas Service
----------------------------------------------------------------------------------------------------------------
Valve................................                      9.6                      5.5                       16
Flange...............................                      6.9                      4.0                       11
Connector (other)....................                      4.9                      2.8                      7.9
Open-Ended Line 2....................                      6.3                      3.6                       10
Pressure Relief Valve................                      7.8                      4.5                       13
Pump Seal............................                       14                      8.3                       23
Other 3..............................                      9.1                      5.3                       15
----------------------------------------------------------------------------------------------------------------
       Leaker Emission Factors--Onshore Petroleum and Natural Gas Production--All Components, Oil Service
----------------------------------------------------------------------------------------------------------------
Valve................................                      5.6                      3.3                      9.2
Flange...............................                      2.7                      1.6                      4.4
Connector (other)....................                      5.6                      3.2                      9.1

Open-Ended Line......................                      1.6                     0.93                      2.6
Pump 4...............................                      3.7                      2.2                      6.0
Other 3..............................                      2.2                      1.0                      2.9
----------------------------------------------------------------------------------------------------------------
\1\ For multi-phase flow that includes gas, use the gas service emission factors.
\2\ The open-ended lines component type includes blowdown valve and isolation valve leaks emitted through the
  blowdown vent stack for centrifugal and reciprocating compressors.
\3\ ``Others'' category includes any equipment leak emission point not specifically listed in this table, as
  specified in Sec.   98.232(c)(21) and (j)(10).
\4\ The pumps component type in oil service includes agitator seals.

0
19. Remove table W-3A and table W-3B to subpart W of part 98 and add
table W-3 to subpart W of part 98 in numerical order to read as
follows:

            Table W-3 to Subpart W of Part 98--Default Total Hydrocarbon Population Emission Factors
----------------------------------------------------------------------------------------------------------------
                                                                                Emission factor (scf total
               Industry segment                        Source type/component              hydrocarbon/ hour/
                                                                                component)
----------------------------------------------------------------------------------------------------------------
                           Population Emission Factors--Storage Wellheads, Gas Service
----------------------------------------------------------------------------------------------------------------
Underground natural gas storage..............  Connector...........................                         0.01
                                               Valve...............................                          0.1
                                               Pressure Relief Valve...............                         0.17
                                               Open-Ended Line.....................                         0.03
----------------------------------------------------------------------------------------------------------------

0
20. Remove table W-4A and table W-4B to subpart W of part 98 and add
table W-4 to subpart W of part 98 in numerical order to read as
follows:

              Table W-4 to Subpart W of Part 98--Default Total Hydrocarbon Leaker Emission Factors
----------------------------------------------------------------------------------------------------------------
                                                 Emission factor (scf total hydrocarbon/hour/component)
                                      --------------------------------------------------------------------------
                                         If you survey using      If you survey using    If you survey using any
         Equipment components           Method 21 as specified   Method 21 as specified   of the methods in Sec.
                                               in Sec.                  in Sec.            98.234(a)(1), (3), or
                                           98.234(a)(2)(i)          98.234(a)(2)(ii)               (5)
----------------------------------------------------------------------------------------------------------------
     Leaker Emission Factors--Onshore Natural Gas Processing, Onshore Natural Gas Transmission Compression--
                                       Compressor Components, Gas Service
----------------------------------------------------------------------------------------------------------------
Valve \1\............................                    14.84                     9.51                     24.2
Connector............................                     5.59                     3.58                     9.13
Open-Ended Line......................                    17.27                    11.07                     28.2
Pressure Relief Valve................                    39.66                    25.42                     64.8
Meter................................                    19.33                    12.39                     31.6
Other \2\............................                      4.1                     2.63                     6.70
----------------------------------------------------------------------------------------------------------------
   Leaker Emission Factors--Onshore Natural Gas Processing, Onshore Natural Gas Transmission Compression--Non-
                                       Compressor Components, Gas Service
----------------------------------------------------------------------------------------------------------------
Valve \1\............................                     6.42                     4.12                     10.5
Connector............................                     5.71                     3.66                      9.3
Open-Ended Line......................                    11.27                     7.22                     18.4
Pressure Relief Valve................                     2.01                     1.29                     3.28
Meter................................                     2.93                     1.88                     4.79
Other \2\............................                      4.1                     2.63                     6.70
----------------------------------------------------------------------------------------------------------------
             Leaker Emission Factors--Underground Natural Gas Storage--Storage Station, Gas Service
----------------------------------------------------------------------------------------------------------------
Valve \1\............................                    14.84                     9.51                     24.2
Connector (other)....................                     5.59                     3.58                     9.13
Open-Ended Line......................                    17.27                    11.07                     28.2
Pressure Relief Valve................                    39.66                    25.42                     64.8
Meter and Instrument.................                    19.33                    12.39                     31.6
Other \2\............................                      4.1                     2.63                     6.70
----------------------------------------------------------------------------------------------------------------

            Leaker Emission Factors--Underground Natural Gas Storage--Storage Wellheads, Gas Service
----------------------------------------------------------------------------------------------------------------
Valve\1\.............................                      4.5                      3.2                     7.35
Connector (other than flanges).......                      1.2                      0.7                     1.96
Flange...............................                      3.8                      2.0                     6.21
Open-Ended Line......................                      2.5                      1.7                     4.08
Pressure Relief Valve................                      4.1                      2.5                     6.70
Other \2\............................                      4.1                      2.5                     6.70
----------------------------------------------------------------------------------------------------------------
\1\ Valves include control valves, block valves and regulator valves.
\2\ Other includes any potential equipment leak emission point in gas service that is not specifically listed in
  this table, as specified in Sec.   98.232(e)(8) for onshore natural gas transmission compression, and as
  specified in Sec.   98.232(f)(6) and (8) for underground natural gas storage.

0
21. Remove table W-5A and table W-5B to subpart W of part 98 and add
table W-5 to subpart W of part 98 in numerical order to read as
follows:

 Table W-5 to Subpart W of Part 98--Default Methane Population Emission
                                 Factors
------------------------------------------------------------------------
                                                    Emission factor (scf
      Industry segment            Source type/          methane/hour/
                                    component            component)
------------------------------------------------------------------------
    Population Emission Factors--LNG Storage Compressor, Gas Service
------------------------------------------------------------------------
LNG storage.................  Vapor Recovery                        4.17
LNG import and export          Compressor \1\.
 equipment.
------------------------------------------------------------------------
   Population Emission Factors--Below Grade Transmission-Distribution
 Transfer Station Components and Below Grade Metering-Regulating Station
                      \2\ Components, Gas Service
------------------------------------------------------------------------
Natural gas distribution....  Below Grade T-D                       0.30
                               Transfer Station.
                              Below Grade M&R                       0.30
                               Station.
------------------------------------------------------------------------
      Population Emission Factors--Distribution Mains, Gas Service
------------------------------------------------------------------------
Natural gas distribution....  Unprotected Steel...                   5.1
                              Protected Steel.....                  0.57
                              Plastic.............                  0.17
                              Cast Iron...........                   6.9
------------------------------------------------------------------------
    Population Emission Factors--Distribution Services, Gas Service
------------------------------------------------------------------------
Natural gas distribution....  Unprotected Steel...                 0.086
                              Protected Steel.....                0.0077
                              Plastic.............                0.0016
                              Copper..............                  0.03
------------------------------------------------------------------------
   Population Emission Factors--Interconnect, Direct Sale, or Farm Tap
                            Station Stations
------------------------------------------------------------------------
Onshore natural gas           Transmission Company                   166
 transmission pipeline.        Interconnect M&R
                               Station.
                              Direct Sale or Farm                    1.3
                               Tap Station.
------------------------------------------------------------------------
    Population Emission Factors--Transmission Pipelines, Gas Service
------------------------------------------------------------------------
Onshore natural gas           Unprotected Steel...                  0.74
 transmission pipeline.
                              Protected Steel.....                 0.041
                              Plastic.............                 0.061
                              Cast Iron...........                    27
------------------------------------------------------------------------
\1\ Emission Factor is in units of ``scf methane/hour/compressor.''
\2\ Excluding customer meters.
\3\ Emission Factor is in units of ``scf methane/hour/station.''
\4\ Emission Factor is in units of ``scf methane/hour/mile.''
\5\ Emission Factor is in units of ``scf methane/hour/number of
  services.''

0
22. Remove table W-6A and table W-6B to subpart W of part 98 and add
table W-6 to subpart W of part 98 in numerical order to read as
follows:

                   Table W-6 to Subpart W of Part 98--Default Methane Leaker Emission Factors
----------------------------------------------------------------------------------------------------------------
                                                      Emission factor (scf methane/hour/component)
                                      --------------------------------------------------------------------------
                                         If you survey using      If you survey using    If you survey using any
         Equipment components           Method 21 as specified   Method 21 as specified   of the methods in Sec.
                                               in Sec.                  in Sec.            98.234(a)(1), (3), or
                                           98.234(a)(2)(i)          98.234(a)(2)(ii)               (5)
----------------------------------------------------------------------------------------------------------------
   Leaker Emission Factors--LNG Storage and LNG Import and Export Equipment--Storage Components and Terminals
                                             Components, LNG Service
----------------------------------------------------------------------------------------------------------------
Valve................................                     1.19                     0.23                     1.94
Pump Seal............................                     4.00                     0.73                     6.54
Connector............................                     0.34                     0.11                     0.56
Other \1\............................                     1.77                     0.99                      2.9
----------------------------------------------------------------------------------------------------------------
   Leaker Emission Factors--LNG Storage and LNG Import and Export Equipment--Storage Components and Terminals
                                             Components, Gas Service
----------------------------------------------------------------------------------------------------------------
Valve \2\............................                    14.84                     9.51                     24.2
Connector............................                     5.59                     3.58                     9.13
Open-Ended Line......................                    17.27                    11.07                     28.2
Pressure Relief Valve................                    39.66                    25.42                     64.8
Meter and Instrument.................                    19.33                    12.39                     31.6
Other \3\............................                      4.1                     2.63                     6.70
----------------------------------------------------------------------------------------------------------------
 Leaker Emission Factors--Natural Gas Distribution--Transmission-Distribution Transfer Station  Components, Gas
                                                     Service
----------------------------------------------------------------------------------------------------------------
Connector............................                     1.69  .......................                     2.76
Block Valve..........................                    0.557  .......................                     0.91
Control Valve........................                     9.34  .......................                     15.3
Pressure Relief Valve................                     0.27  .......................                     0.44
Orifice Meter........................                    0.212  .......................                     0.35
Regulator............................                    0.772  .......................                     1.26
Open-ended Line......................                   26.131  .......................                     42.7
----------------------------------------------------------------------------------------------------------------
\1\ ``Other'' equipment type for components in LNG service should be applied for any equipment type other than
  connectors, pumps, or valves.
\2\ Valves include control valves, block valves and regulator valves.
\3\ ``Other'' equipment type for components in gas service should be applied for any equipment type other than
  valves, connectors, flanges, open-ended lines, pressure relief valves, and meters and instruments, as
  specified in Sec.   98.232(g)(6) and (7) and Sec.   98.232(h)(7) and (8).
\4\ Excluding customer meters.

0
23. Revise table W-7 to subpart W of part 98 to read as follows:

 Table W-7 to Subpart W of Part 98--Default Methane Emission Factors for
                      Internal Combustion Equipment
------------------------------------------------------------------------
                                                        Emission factor
         Internal combustion equipment type             (kg CH4/mmBtu)
------------------------------------------------------------------------
Reciprocating Engine, 2-stroke lean-burn............               0.658
Reciprocating Engine, 4-stroke lean-burn............               0.522
Reciprocating Engine, 4-stroke rich-burn............               0.045
Gas Turbine.........................................               0.004
------------------------------------------------------------------------

[FR Doc. 2023-14338 Filed 7-31-23; 8:45 am]
 BILLING CODE 6560-50-P


[Federal Register Volume 76, Number 225 (Tuesday, November 22, 2011)]
[Notices]
[Pages 72202-72203]
[FR Doc No: 2011-30123]

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

DEPARTMENT OF ENERGY

Federal Energy Regulatory Commission

[Project No. 14306-000]

 The City of East Providence; Notice of Preliminary Permit
Application Accepted for Filing and Soliciting Comments, Motions To
Intervene, and Competing Applications

    On October 14, 2011, The City of East Providence filed an
application for a preliminary permit, pursuant to section 4(f) of the
Federal Power Act (FPA), proposing to study the feasibility of the
Hunt's Mill Dam Hydropower Project (Hunt's Mill Dam Project or project)
to be located on Ten Mile River, in the City of East Providence,
Providence County, Rhode Island. The sole purpose of a preliminary
permit, if issued, is to grant the permit holder priority to file a
license application during the permit term. A preliminary permit does
not authorize the permit holder to perform any land-disturbing
activities or otherwise enter upon lands or waters owned by others
without the owners' express permission.
    The proposed project would consist of the following: (1) The
existing 175-foot-long Hunt's Mill dam, which is owned by the City of
East Providence, Rhode Island and includes a 125-foot-long, 10-foot-
high curved stone masonry spillway; (2) an existing 32 acre impoundment
with 140 acre-feet of storage capacity at elevation 33.5 feet NAVD 88;
(3) a newly constructed or refurbished powerhouse; (4) a new or
refurbished vertical Francis turbine/generator with total hydraulic
capacity of 100 cubic feet per second (cfs) and total installed
generating capacity of 0.3 megawatts connected to a rehabilitated or
new penstock; (5) a rehabilitated intake, with new downstream fish
protection measures; (6) an existing 900-foot-long open tailrace
channel; (7) an existing switchyard with interconnected transmission
line located at the existing powerhouse; and (8) appurtenant
facilities. The estimated annual generation of the Hunt's Mill Dam
Project would be 0.85 gigawatt-hours (GWH).
    Applicant Contact: Mr. Jonathan Petrillo, Agent, The Essex
Partnership, LLC, 27 Vaughan Ave., Newport, RI 02840; phone: (401) 619-
4872.
    FERC Contact: John Ramer; phone:<PHONE_NUMBER>.
    Deadline for filing comments, motions to intervene, competing
applications (without notices of intent), or notices of intent to file
competing applications: 60 days from the issuance of this notice.
Competing applications and notices of intent must meet the requirements
of 18

CFR 4.36. Comments, motions to intervene, notices of intent, and
competing applications may be filed electronically via the Internet.
See 18 CFR 385.2001(a)(1)(iii) and the instructions on the Commission's
Web site 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_ADDRESS>or toll free at 1-866-208-3676,
or for TTY,<PHONE_NUMBER>. Although the Commission strongly encourages
electronic filing, documents may also be paper-filed. To paper-file,
mail an original and seven copies to: Kimberly D. Bose, Secretary,
Federal Energy Regulatory Commission, 888 First Street NE., Washington,
DC 20426.
    More information about this project, including a copy of the
application, can be viewed or printed on the ``eLibrary'' link of
Commission's Web site at http://www.ferc.gov/docs-filing/elibrary.asp.
Enter the docket number (P-14306-000) in the docket number field to
access the document. For assistance, contact FERC Online Support.

    Dated: November 16, 2011.
Kimberly D. Bose,
Secretary.
[FR Doc. 2011-30123 Filed 11-21-11; 8:45 am]
BILLING CODE 6717-01-P


[Federal Register: February 25, 2010 (Volume 75, Number 37)]
[Notices]
[Page 8762]
[DOCID:fr25fe10-135]

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

SECURITIES AND EXCHANGE COMMISSION

[Release No. 34-61546; File No. 4-546]

Joint Industry Plan; Notice of Filing and Immediate Effectiveness
of Amendment to the Options Order Protection and Locked/Crossed Market
Plan To Add the BATS Exchange, Inc. as a Participant

February 19, 2010.
    Pursuant to Section 11A(a)(3) of the Securities Exchange Act of
1934 (``Act'') \1\ and Rule 608 thereunder,\2\ notice is hereby given
that on February 4, 2010, BATS Exchange, Inc. (``BATS'' or
``Exchange'') filed with the Securities and Exchange Commission
(``Commission'') an amendment to the Options Order Protection and
Locked/Crossed Market Plan (``Plan'').\3\ The amendment proposes to add
BATS as a Participant \4\ to the Plan. The Commission is publishing
this notice to solicit comments on the proposed rule change from
interested persons.
---------------------------------------------------------------------------

    \1\ 15 U.S.C. 78k-1(a)(3).
    \2\ 17 CFR 242.608.
    \3\ On July 30, 2009, the Commission approved a national market
system plan relating to Options Order Protection and Locked/Crossed
Markets proposed by Chicago Board Options Exchange, Incorporated
(``CBOE''), International Securities Exchange, LLC (``ISE''), The
NASDAQ Stock Market LLC (``Nasdaq''), NASDAQ OMX BX, Inc. (``BOX''),
NASDAQ OMX PHLX, Inc. (``Phlx''), NYSE Amex, LLC (``NYSE Amex''),
and NYSE Arca, Inc. (``NYSE Arca''). See Securities Exchange Act
Release No. 60405 (July 30, 2009), 74 FR 39362 (August 6, 2009).
    \4\ The term ``Participant'' is defined as an Eligible Exchange
whose participation in the Plan has become effective pursuant to
Section 3(c) of the Plan.
---------------------------------------------------------------------------

I. Description and Purpose of the Amendment

    The current Participants in the Linkage Plan are CBOE, ISE, Nasdaq,
BOX, Phlx, NYSE Amex, and NYSE Arca. The proposed amendment to the Plan
would add BATS as a Participant in the Plan. BATS has submitted a
signed copy of the Plan to the Commission in accordance with the
procedures set forth in the Plan regarding new Participants. Section
3(c) of the Plan provides for the entry of new Participants to the
Plan. Specifically an Eligible Exchange \5\ may become a Participant in
the Plan by: (i) Executing a copy of the Plan, as then in effect; (ii)
providing each current Participant with a copy of such executed Plan;
(iii) effecting an amendment to the Plan, as specified in Section 4(b)
of the Plan.
---------------------------------------------------------------------------

    \5\ Section 2(6) of the Plan defines an ``Eligible Exchange'' as
a national securities exchange registered with the Commission
pursuant to Section 6(a) of the Act, 15 U.S.C. 78f(a), that: (a) is
a ``Participant Exchange'' in the Options Clearing Corporation
(``OCC'') (as defined in OCC By-laws, Section VII); (b) is a party
to the Options Price Reporting Authority (``OPRA'') Plan (as defined
in the OPRA Plan, Section 1); and (c) if the national securities
exchange chooses not to become party to this Plan, is a participant
in another plan approved by the Commission providing for comparable
Trade-Through and Locked and Crossed Market protection. BATS has
represented that it has met the requirements for being considered an
Eligible Exchange. See letter from Eric Swanson, SVP and General
Counsel, BATS, to David Liu, Assistant Director, Division of Trading
and Markets, Commission, dated February 12, 2010.
---------------------------------------------------------------------------

    Section 4(b) of the Plan puts forth the process by which an
Eligible Exchange may effect an amendment to the Plan. Specifically, an
Eligible Exchange must: (a) execute a copy of the Plan with the only
change being the addition of the new participant's name in Section 3(a)
of the Plan; and (b) submit the executed Plan to the Commission. The
Plan then provides that such an amendment will be effective when the
amendment is approved by the Commission or otherwise becomes effective
pursuant to Section 11A of the Act and Rule 608 thereunder.

II. Effectiveness of the Proposed Linkage Plan Amendment

    The foregoing proposed Plan amendment has become effective pursuant
to Rule 608(b)(3)(iii) of the Act \6\ because it involves solely
technical or ministerial matters. At any time within sixty days of the
filing of this amendment, the Commission may summarily abrogate the
amendment and require that it be refiled pursuant to paragraph (b)(1)
of Rule 608,\7\ if it appears to the Commission that such action is
necessary or appropriate in the public interest, for the protection of
investors or the maintenance of fair and orderly markets, to remove
impediments to, and perfect the mechanisms of, a national market system
or otherwise in furtherance of the purposes of the Act.
---------------------------------------------------------------------------

    \6\ 17 CFR 242.608(b)(3)(iii).
    \7\ 17 CFR 242.608(b)(1).
---------------------------------------------------------------------------

III. Solicitation of Comments

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

Electronic Comments

     Use the Commission's Internet comment form (http://
www.sec.gov/rules/sro.shtml); or
     Send an e-mail to<EMAIL_ADDRESS>Please include
File Number 4-546 on the subject line.

Paper Comments

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

All submissions should refer to File Number 4-546. This file number
should be included on the subject line if e-mail is used. To help the
Commission process and review your comments more efficiently, please
use only one method. The Commission will post all comments on the
Commission's Internet Web site (http://www.sec.gov/rules/sro.shtml).
Copies of the submission, all subsequent amendments, all written
statements with respect to the proposed rule change that are filed with
the Commission, and all written communications relating to the proposed
rule change between the Commission and any person, other than those
that may be withheld from the public in accordance with the provisions
of 5 U.S.C. 552, will be available for Web site viewing and printing in
the Commission's Public Reference Room, 100 F Street, NE., Washington,
DC 20549, on official business days between the hours of 10 a.m. and 3
p.m. Copies of such filing also will be available for inspection and
copying at the principal office of BATS. All comments received will be
posted without change; the Commission does not edit personal
identifying information from submissions. You should submit only
information that you wish to make available publicly. All submissions
should refer to File Number 4-546 and should be submitted on or before
March 18, 2010.

    For the Commission, by the Division of Trading and Markets,
pursuant to delegated authority.\8\
---------------------------------------------------------------------------

    \8\ 17 CFR 200.30-3(a)(29).
---------------------------------------------------------------------------

Florence E. Harmon,
Deputy Secretary.
[FR Doc. 2010-3823 Filed 2-24-10; 8:45 am]
BILLING CODE 8011-01-P