SUPPORTING STATEMENT

ENVIRONMENTAL PROTECTION AGENCY

NSPS for Industrial-Commercial-Institutional Steam Generating Units (40
CFR Part 60, Subpart Db) (Renewal)

1.  Identification of the Information Collection

1(a)  Title of the Information Collection

NSPS for Industrial-Commercial-Institutional Steam Generating Units (40
CFR Part 60, Subpart Db)

1(b)  Short Characterization/Abstract

	The New Source Performance Standards (NSPS) for the regulations
published at 40 CFR part 60, subpart Db for the pollutant sulfur dioxide
(SO2) were proposed on June 19, 1986, and promulgated on December 16,
1987.  These regulations apply to industrial-commercial-institutional
steam generating units (boilers) that commenced construction,
modification, or reconstruction after June 19, 1984, and that have a
heat input capacity from fuels combusted in the unit of greater than 29
MW (100 million Btu/hour).  The regulations were amended on February 27,
2006 (71 FR 9865), June 13, 2007 (72 FR 32710), and on January 28, 2009
(74 FR 5086).  This ICR is updated to reflect changes due to the 2007
and 2009 amendments.  The 2007 amendments added compliance alternatives,
revised certain recordkeeping and reporting requirements, corrected
technical and editorial errors, and updated the grammatical style of the
four D subparts.  The 2009 amendments clarified the intent for applying
and implementing specific rule requirements, provided additional
compliance alternatives, and corrected unintentional technical omissions
and editorial errors.  This information is being collected to assure
compliance with 40 CFR part 60, subpart Db.

	In general, all NSPS standards require initial notifications,
performance tests, and periodic reports.  Owners or operators are also
required to maintain records of the occurrence and duration of any
startup, shutdown, or malfunction in the operation of an affected
facility, or any period during which the monitoring system is
inoperative.  These notifications, reports, and records are essential in
determining compliance, and are required of all sources subject to NSPS.

	Any owner or operator subject to the provisions of this part shall
maintain a file of these measurements, and retain the file for at least
two years following the date of such measurements, maintenance reports,
and records.  All reports are sent to the delegated state or local
authority.  In the event that there is no such delegated authority, the
reports are sent directly to the United States Environmental Protection
Agency (EPA) regional office.

Size of the Regulated Community

	In a study from 1979, EPA modeled the total capacity of United States
(U.S.) industrial/commercial boilers for 1980, 1985 and 2000, for
boilers with capacities greater than 29 MW (100 million BTU/hour)
(“Population and Characteristics of Industrial/Commercial Boilers in
the United States from 1979"; EPA Number PB80 - 150881).  This model
shows an increase of 4,139 new industrial/commercial boilers between
1985 and 2000 with capacities greater than 29 MW (100 million BTU/hour),
and these would be subject to NSPS Db.  Therefore, according to this
model there should be approximately 4,139 steam generating units (or
boilers) currently subject to NSPS subpart Db.  Assuming one boiler per
facility, the number of facilities subject to NSPS subpart Db would be
4,139.

	However, during the nitrogen oxide (NOx) NSPS revision, information on
industrial boilers subject to NSPS Db was obtained from three sources: a
best available technology/ lowest achievable emission rate database
search; copies of permits obtained from EPA regional offices; and
telephone contacts with EPA regions, state agencies, and boiler vendors.
 Based on the information obtained, as of 1995, only 45 NSPS Db boilers
were identified.  Since NSPS Db was in effect for ten years in 1995, 45
boilers is probably a low number and model projects indicate that it may
be far from the true regulated universe for 1995.  The Information
Collection Request (ICR) approved in 2000 estimated 957 facilities
subject to NSPS Db.

	During the NOx NSPS revision mentioned above, an analysis was conducted
to determine the projected growth of new industrial boilers over the
period from 1996 to 2000.  This analysis showed that the growth rate
would be 76 new industrial boilers per year.  Therefore, using the
estimate from the ICR approved in 2000 of 957 sources, assuming a growth
rate of 76 new industrial boilers per year over the three-year period
since the last ICR, and assuming one boiler per facility, the 2003 ICR
estimated 1,185 existing NSPS Db facilities.  The 2006 ICR renewal
assumed no change in the total estimate of 1,185 existing NSPS Db
facilities.

Growth Rate for the Next Three Years

	In the Industrial Boiler   SEQ CHAPTER \h \r 1 Maximum Achievable
Control Technology (MACT) rulemaking, a projection of new industrial,
commercial, and institutional boilers was performed for economic
analysis in October 2002.  This analysis showed that 134 industrial,
commercial, and institutional boilers would become subject to NSPS
subpart Db over the next three years (or 45 per year).  This is the most
recent growth projection available for these facilities.

	This ICR estimates the existing number of sources based on the 2003 ICR
estimate of 1,185 existing sources plus 270 new facilities over a
six-year period (assuming a growth rate of 45 facilities per year over
six years).  Therefore, this ICR is estimating that approximately 1,455
existing sources are currently subject to the regulation; and it is
estimated that an additional 45 new sources per year will become subject
to the regulation in the next three years.

	The Office of Management and Budget (OMB) approved the currently active
ICR without any “Terms of Clearance.”

	The burden to the “Affected Public” may be found in Table 1: Annual
Respondent Burden and Cost  - NSPS for
Industrial-Commercial-Institutional Steam Generating Units (40 CFR part
60, subpart Db).  The burden to the “Federal Government” is
attributed entirely to work performed by Federal employees or government
contractors; this burden may be found in Table 2: Average Annual EPA
Burden - NSPS for Industrial-Commercial-Institutional Steam Generating
Units (40 CFR part 60, subpart Db).

2.  Need for and Use of the Collection

2(a)  Need/Authority for the Collection

The EPA is charged under section 111 of the Clean Air Act (CAA), as
amended, to establish standards of performance for new stationary
sources that reflect:

. . . application of the best technological system of continuous
emissions reduction which (taking into consideration the cost of
achieving such emissions reduction, or any non-air quality health and
environmental impact and energy requirements) the Administrator
determines has been adequately demonstrated.  Section 111(a)(l).

The Agency refers to this charge as selecting the best demonstrated
technology (BDT).  Section 111 also requires that the Administrator
review and, if appropriate, revise such standards every four years.

In addition, section 114(a) states that the Administrator may require
any owner/operator subject to any requirement of this Act to:

(A) Establish and maintain such records; (B) make such reports; (C)
install, use, and maintain such monitoring equipment, and use such audit
procedures, or methods; (D) sample such emissions (in accordance with
such procedures or methods, at such locations, at such intervals, during
such periods, and in such manner as the Administrator shall prescribe);
(E) keep records on control equipment parameters, production variables
or other indirect data when direct monitoring of emissions is
impractical; (F) submit compliance certifications in accordance with
Section 114(a)(3); and (G) provide such other information as the
Administrator may reasonably require.

In the Administrator's judgment, SO2, particulate matter (PM), and NOx
emissions from Industrial-Commercial-Institutional Steam Generating
units cause or contribute to air pollution that may reasonably be
anticipated to endanger public health or welfare.  Therefore, the NSPS
were promulgated for this source category at 40 CFR part 60, subpart Db.

2(b)  Practical Utility/Users of the Data

	The control of emissions of SO2, PM, and NOx from
Industrial-Commercial-Institutional Steam Generating units requires not
only the installation of properly designed equipment, but also the
operation and maintenance of that equipment.  Emissions of SO2, PM, and
NOx from Industrial-Commercial-Institutional Steam Generating units are
the result of operation of the affected facilities.  The subject
standards are achieved by the capture and/or reduction of SO2, PM, and
NOx emissions using control technologies such as sorbent injection
technologies and wet and dry scrubbers for SO2; cyclones, electrostatic
precipitators, and fabric filters for PM; and low NOx burners and
selective catalytic or noncatalytic reduction technologies for NOx.

	The notifications required in the applicable regulations are used to
inform the Agency, or delegated authority, when a source becomes subject
to the requirements of the regulations.  The reviewing authority may
then inspect the source to check if the pollution control devices are
properly installed and operated and the regulations are being met.

	Performance test reports are needed as these are the Agency's record of
a source's initial capability to comply with the emission standards, and
serve as a record of the operating conditions under which compliance was
achieved.  Continuous emission monitors are used to ensure compliance
with the standards at all times.

	The information generated by the monitoring, recordkeeping and
reporting requirements described in this ICR is used by the Agency to
ensure that facilities affected by the NSPS continue to operate the
control equipment and achieve compliance with the regulation.  Adequate
monitoring, recordkeeping, and reporting are necessary to ensure
compliance with the applicable regulations, as required by the Clean Air
Act.  The collected information is also used for targeting inspections
and as evidence in legal proceedings.

The required quarterly or semiannual reports are used to determine
periods of excess emissions, identify problems at the facility, verify
operation/maintenance procedures and for compliance determinations.

3.  Nonduplication, Consultations, and Other Collection Criteria

The requested recordkeeping and reporting are required under 40 CFR part
60, subpart Db.

3(a)  Nonduplication

 If the subject standards have not been delegated, the information is
sent directly to the appropriate EPA regional office.  Otherwise, the
information is sent directly to the delegated state or local agency.  If
a state or local agency has adopted its own similar standards to
implement the Federal standards, a copy of the report submitted to the
state or local agency can be sent to the Administrator in lieu of the
report required by the Federal standards.  Therefore, no duplication
exists.

3(b)  Public Notice Required Prior to ICR Submission to OMB

An announcement of a public comment period for the renewal of this ICR
was published in the Federal Register (74 FR 38004) on July 30, 2009.
No comments were received on the burden published in the Federal
Register.

3(c)  Consultations

In determining the correct burden estimate associated with this ICR,
industry trade associations and other interested parties have been
provided an opportunity to comment on the burden associated with the
standard as it was being developed and in subsequent renewals of the
ICR.  It is our policy to review any comments received since the last
ICR renewal including those submitted in response to the first Federal
Register notice and respond appropriately.  EPA published an
announcement of a public comment period for the renewal of this ICR in
the Federal Register on July 30, 2009.  No comments were received on
respondent burden associated with the reporting and recordkeeping
requirements provided in this ICR.

To determine the size of the regulated community and the rate of
industry growth, the EPA Office of Air Quality Planning and Standards
was consulted.  The Agency’s internal industry experts have been
consulted.  The Agency’s internal data sources and projections of
industry growth over the next three years also have been considered.

	Another source of information from the 2003 renewal was the information
provided by the industry.  Information provided in the industry reports
is located in the EPA’s AFS (Air Facility System) database.  In 2003,
approximately 1,230 respondents were subject to the regulation.

It should be noted that the industry trade associations and other
interested parties were provided an opportunity to comment on the burden
associated with the standard as it was being developed, and the standard
has been previously reviewed to determine the minimum information needed
for compliance purposes.

For this renewal, EPA contacted a representative industry trade
organization to request a voluntary opinion as to the accuracy of the
burden estimates associated with this ICR and whether there is any way
to reduce the burden.  EPA contacted the Council of Industrial Boiler
Owners (CIBO, Bob Bessette, telephone:<PHONE_NUMBER>); no comments were
received.

3(d)  Effects of Less Frequent Collection

Less frequent information collection would decrease the margin of
assurance that facilities are continuing to meet the standards.
Requirements for information gathering and recordkeeping are useful
techniques to ensure that good operation and maintenance practices are
applied and emission limitations are met.  If the information required
by these standards was collected less frequently, the proper operation
and maintenance of control equipment and the possibility of detecting
violations would be less likely.

3(e)  General Guidelines

These reporting or recordkeeping requirements do not violate any of the
regulations promulgated by OMB under 5 CFR part 1320, section 1320.5.

3(f)  Confidentiality

Any information submitted to the Agency for which a claim of
confidentiality is made will be safeguarded according to the Agency
policies set forth in title 40, chapter 1, part 2, subpart B -
Confidentiality of Business Information (see 40 CFR 2; 41 FR 36902,
September 1, 1976; amended by 43 FR 40000, September 8, 1978; 43 FR
42251, September 20, 1978; 44 FR 17674, March 23, 1979).

3(g)  Sensitive Questions

The reporting or recordkeeping requirements in the standard do not
include sensitive questions.

4.  The Respondents and the Information Requested

4(a)  Respondents/SIC Codes

	Industrial-commercial-institutional boilers (also known as steam
generating units) are classified by type, fuel, and method of
construction.  The three main types are cast iron, fire tube, and water
tube.  These three categories of boilers are designed and manufactured
to meet specific applications and site requirements.  Unit size, design
pressure and temperature all depend on boiler application.  Each boiler
type may burn coal, oil, or natural gas, and increasingly are being
designed to burn more than one fuel type.

	All boilers subject to NSPS subpart Db are water tube boilers.  Water
tube boilers are used in a variety of applications ranging from
supplying large amounts of process steam to providing space heat for
industrial facilities, or commercial buildings.  Water tube boilers are
fueled by coal, 25 percent; oil, 32 percent, and natural gas, 43
percent.  Process steam accounts for the largest use of fuel to fire
boilers, using about one-third of all industrial fuel.

	The following industries use water tube boilers with capacities greater
than 29 MW (100 mmBtu/hr).  In EPA studies, energy usage was used to
estimate the potential for industry boiler usage.  The chemical and
paper industries use the most energy accounting for about a third of all
U.S. industrial fuel usage.  Petroleum refineries, steel and aluminum
manufacturers, and food processing industries use most of the remainder
of industrial fuel.  Other industries using smaller, but significant
amounts of fuel are the textiles, lumber, and rubber manufacturers, and
metal fabrication and transportation industries.  The other two
industries that would be expected to have boilers large enough to be
subject to NSPS subpart Db are office and shopping center heating and
boiler rentals.

	The respondents to the recordkeeping and reporting requirements are
facilities subject to NSPS subpart Db that commenced construction,
modification, or reconstruction after June 19, 1984, and that have a
heat input capacity from fuels combusted in the steam generating unit of
greater than 29 MW (100 mmBtu/hr).

Regulation	SIC Codes	NAICS Codes

40 CFR part 60, subpart Db	1531	23332

	2033	311421

	Major Group 22	Major Group 313

	Major Group 24	Major Group 321

	2611	322110

	Major Group 28	Major Group 325

	2911	324110

	Major Group 30	Major Group 326

	Major Group 33	Major Group 331

	Major Group 34	Major Group 332

	Major Group 37	Major Group 336

	7299	81299

4(b)  Information Requested

(i)  Data Items

	In this ICR, all the data that is recorded or reported is required by
NSPS for Industrial-Commercial-Institutional Steam Generating Units (40
CFR part 60, subpart Db).

	A source must make the following reports:

Reports for 40 CFR part 60, subpart Db

Construction/reconstruction	60.7(a)(1)

Actual startup	60.7(a)(3), 60.49b(a)

Initial performance test results	60.8 (a), 60.49b(b)

Initial performance test	60.8(d)

Demonstration of continuous monitoring system	60.7(a)(5)

Physical or operational change	60.7(a)(4)

Operating conditions for compliance with NOx standard	60.49b(c)

Monitoring results	60.49b(i)-(m)

Annual Capacity Factor, Fuel Nitrogen Content, NOx Emission Tests
60.49b(q)

Fuel-based Compliance Alternative Report	60.49b(r)

Removal efficiency by fuel pretreatment and associated documentation
60.49b(n)

Excess emissions (semiannual)	60.7(c), 60.49b(h), 60.49b(w)

Quarterly reporting for Cytec Industries Fortier Plant’s C.AOG
incinerator, Westwego, Louisiana	60.49b(s)

Quarterly reporting for Rohm and Haas Kentucky Incorporated’s Boiler
Number 100, Louisville, Kentucky	60.49b(t)

Quarterly reporting for Merck & Co., Inc.’s Stonewall Plant, Elkton,
Virginia	60.49b(u)

Quarterly reporting for Weyerhaeuser Company’s No. 2 Power Boiler, New
Bern, North Carolina	60.49(x)

Quarterly reporting for INEOS USA’s AOGI, Lima, Ohio	60.49b(y)

Quarterly reporting (electronic)	60.49b(v)

	A source must maintain the following records:

Recordkeeping for 40 CFR part 60, subpart Db

Startups, shutdowns, malfunctions, and periods when the continuous
monitoring system is inoperative.	60.7(b)

Fuel Monitoring	60.49b(d), 60.49b(r)

Nitrogen content of residual oil combusted	60.49b(e)

Opacity	60.49b(f)

Nitrogen oxide emission rates	60.49b(g)

Records are required to be retained at the facility for two years.
60.7(f), 60.49b(o)

Steam load	60.49b(p)

Fuel Receipts	60.49b(r)

Electronic Reporting

Some of the respondents are using monitoring equipment that
automatically records parameter data.  Although personnel at the
affected facility must still evaluate the data, internal automation has
significantly reduced the burden associated with monitoring and
recordkeeping at a plant site.

Also, regulatory agencies in cooperation with the respondents continue
to create reporting systems to transmit data electronically.  However,
electronic reporting systems are still not widely used.  At this time,
it is estimated that approximately 20 percent of the respondents use
electronic reporting.

(ii)  Respondent Activities

Respondent Activities

Read instructions.

Install, calibrate, maintain, certify, and operate Continuous Emission
Monitoring Systems for NOx, SO2, and opacity or alternative monitoring
methods (e.g., CO CEMS in place of using a COMS).

Perform initial performance test.

Write the notifications and reports listed above.

Enter information required to be recorded above.

Submit the required reports developing, acquiring, installing, and
utilizing technology and systems for the purpose of collecting,
validating, and verifying information.

Develop, acquire, install, and utilize technology and systems for the
purpose of processing and maintaining information.

Develop, acquire, install, and utilize technology and systems for the
purpose of disclosing and providing information.

Adjust the existing ways to comply with any previously applicable
instructions and requirements.

Train personnel to be able to respond to a collection of information.

Transmit, or otherwise disclose the information.

5.  The Information Collected:  Agency Activities, Collection
Methodology, and Information Management

5(a)  Agency Activities

EPA conducts the following activities in connection with the
acquisition, analysis, storage, and distribution of the required
information.

Agency Activities

Review notifications and reports, including performance test reports and
excess emissions reports, required to be submitted by industry.

Audit facility records.

Input, analyze, and maintain data in the Air Facility System (AFS).

5(b)  Collection Methodology and Management

	Following notification of startup, the reviewing authority might
inspect the source to determine whether the pollution control devices
are properly installed and operated.  Performance test reports are used
by the Agency to discern a source’s initial capability to comply with
the emission standard.  Data and records maintained by the respondents
are tabulated and published for use in compliance and enforcement
programs.  The semiannual reports are used for problem identification,
as a check on source operation and maintenance, and for compliance
determinations.

Information contained in the reports is entered into the AFS which is
operated and maintained by the EPA Office of Compliance.  AFS is EPA’s
database for the collection, maintenance, and retrieval of compliance
data for approximately 125,000 industrial and government-owned
facilities.  EPA uses the AFS for tracking air pollution compliance and
enforcement by local and state regulatory agencies, EPA regional offices
and EPA headquarters.  EPA and its delegated Authorities can edit,
store, retrieve and analyze the data.

The records required by this regulation must be retained by the
owner/operator for two years.

5(c)  Small Entity Flexibility

According to the 2005 Economic Impacts Analysis for the Proposed NSPS
amendments in 2005 (see Docket ID: EPA-HQ-OAR-2005-0031-0059) 2 of the
17 or 12 percent of the projected new biomass units were expected to be
small entities.  Applying this percent to the respondent universe for
this ICR results in approximately 180 small entities impacted by this
ICR..

5(d)  Collection Schedule

The specific frequency for each information collection activity within
this request is shown in below Table 1:  Annual Respondent Burden and
Cost - NSPS for Industrial-Commercial-Institutional Steam Generating
Units (40 CFR part 60, subpart Db).

6.  Estimating the Burden and Cost of the Collection

Table 1 documents the computation of individual burdens for the
recordkeeping and reporting requirements applicable to the industry for
the subpart included in this ICR.  The individual burdens are expressed
under standardized headings believed to be consistent with the concept
of burden under the Paperwork Reduction Act.  Where appropriate,
specific tasks and major assumptions have been identified.  Responses to
this information collection are mandatory.

The Agency may not conduct or sponsor, and a person is not required to
respond to, a collection of information unless it displays a currently
valid OMB Control Number.

6(a)  Estimating Respondent Burden

The average annual burden to industry over the next three years from
these recordkeeping and reporting requirements is estimated to be
771,889 hours (Total Labor Hours from Table 1).  The recordkeeping hours
shown in Table 1 are 234,045.  The reporting requirement hours shown in
Table 1 are 537,844.  These hours are based on Agency studies and
background documents from the development of the regulation, Agency
knowledge and experience with the NSPS program, the previously approved
ICR, and any comments received.

6(b)  Estimating Respondent Costs

(i)  Estimating Labor Costs

This ICR uses the following labor rates:

Managerial	$114.77 ($54.65 + 110%)

Technical	$97.59 ($46.47 + 110%)

Clerical	$48.26 ($22.98 + 110%)

These rates are from the United States Department of Labor, Bureau of
Labor Statistics, March 2009, “Table 2. Civilian Workers, by
occupational and industry group.”  The rates are from column 1,
“Total compensation.”  The rates have been increased by 110 percent
to account for the benefit packages available to those employed by
private industry.

(ii)  Estimating Capital/Startup and Operation and Maintenance Costs

The type of industry costs associated with the information collection
activities in the subject standard are both labor costs which are
addressed elsewhere in this ICR and the costs associated with continuous
monitoring.  The capital/startup costs are one time costs when a
facility becomes subject to the regulation.  The annual operation and
maintenance costs are the ongoing costs to maintain the monitors and
other costs such as photocopying and postage.

(iii)  Capital/Startup vs. Operation and Maintenance (O&M) Costs

Capital/Startup vs. Operation and Maintenance (O&M) Costs

(A)

Continuous Monitoring Device	(B)

Startup Cost ($) for One Affected Facility	(C)

Number of New Affected Facilities to Startup	(D)

Total Startup

(B X C)	(E)

Annual O&M Costs ($) for One Affected Facility	(F)

Number of Affected Facilities with O&M	(G)

Total O&M

(E X F)

SO2, PM, and NOx	$200,000	45	$9,000,000	$15,000	1,500	$22,500,000

The total capital/startup costs for this ICR are $9,000,000.  This is
the total of column D in the above table.

The total operation and maintenance (O&M) costs for this ICR are
$22,500,000.  This is the total of column G.

The average annual cost for capital/startup and operation and
maintenance costs to industry over the next three years of the ICR is
estimated to be $31,500,000.  These are recordkeeping costs.

6(c)  Estimating Agency Burden and Cost

The only costs to the Agency are those costs associated with analysis of
the reported information.  EPA's overall compliance and enforcement
program includes activities such as the examination of records
maintained by the respondents, periodic inspection of sources of
emissions, and the publication and distribution of collected
information.

The average annual Agency cost during the three years of the ICR is
estimated to be $27,885,868 (see Table 2).

This cost is based on the average hourly labor rate as follows:

	Managerial	$61.36 (GS-13, Step 5, $38.35 + 60%)

	Technical	$45.52 (GS-12, Step 1, $28.45 + 60%)

	Clerical	$24.64 (GS-6, Step 3, $15.40 + 60%)

These rates are from the Office of Personnel Management (OPM), 2009
General Schedule, which excludes locality rates of pay.  The rates have
been increased by 60 percent to account for the benefit packages
available to government employees.  Details upon which this estimate is
based appear below in Table 2: Annual Agency Burden and Cost - NSPS for
Industrial-Commercial-Institutional Steam Generating Units (40 CFR Part
60, Subpart Db).

6(d)  Estimating the Respondent Universe and Total Burden and Costs

	Approximately 1,455 sources are currently subject to the regulation,
and it is estimated that an additional 45 sources per year will become
subject to the regulation in the next three years.

Respondent Universe and Number of Responses Per Year

Regulation Citation	(A)

Average Number of New Respondents per Year	(B)

Number of Reports for New Sources	(C)

Number of Existing Respondents	(D)

Number of Reports for Existing Sources	(E)

Number of Respondents That Keep Records But Do Not Submit Reports	(F)

Total Annual Responses =

(AxB)+(CxD)+ E

40 CFR 60.49b (w)	36	2	1,164	2	0	2,400

40 CFR 60.49b (v)	9	4	291	4	0	1,200

Total	45

1,455

	3,600

	The number of total respondents is 1,500.  This number is the sum of
column A and column C of the Respondent Universe and Number of Responses
Per Year table.  This represents the number of existing sources and the
number of new sources averaged over the three-year period (i.e., the
number of new respondents over the three-year period divided by three
years).

	The number of Total Annual Responses is 3,600.

	The total annual labor costs are $63,338,557.  Details upon which this
estimate is based appear in Table 1: Annual Respondent Burden and Cost -
NSPS for Industrial-Commercial-Institutional Steam Generating Units (40
CFR Part 60, Subpart Db).

	The total annual capital and O&M costs to the regulated entities are
$31,500,000.

6(e)  Bottom Line Burden Hours and Cost Tables

The detailed bottom line burden hours and cost calculations for the
respondents and the Agency are shown in Tables 1 and 2 below,
respectively, and summarized below.

(i) Respondent Tally

The total annual labor hours are 771,889.  Details regarding these
estimates may be found in Table 1. Annual Respondent Burden and Cost -
NSPS for Industrial-Commercial-Institutional Steam Generating Units (40
CFR Part 60, Subpart Db) (below).  Furthermore, the annual public
reporting and recordkeeping burden for this collection of information is
estimated to average 214 hours per response.

The total annual capital/startup and O&M costs to the regulated entity
are $31,500,000.  The cost calculations are detailed in Section
6(b)(iii), Capital/Startup vs. Operation and Maintenance (O&M) Costs.

(ii) The Agency Tally

The average annual Agency burden and cost over next three years is
estimated to be 777,014 labor hours at a cost of $27,885,868.  See Table
2: Annual Agency Burden and Cost - NSPS for
Industrial-Commercial-Institutional Steam Generating Units (40 CFR Part
60, Subpart Db).

6(f)  Reasons for Change in Burden

The increase in burden from the most recently approved ICR is due to
adjustment.  Growth rate in the number of existing sources since
previous approved ICRs has been taken into account, along with projected
growth rate for the three years covered by this ICR.  The total number
of respondents has increased from 1,185 to 1,500 which results in a
larger number of respondents, responses, and burden hours.

The increase in burden is also related to calculation errors in the
previous ICR calculations in Table 1: Annual Respondent Burden and Cost
- NSPS for Industrial-Commercial-Institutional Steam Generating Units
(40 CFR Part 60, Subpart Db).  Corrections have been made to Table 1 of
this ICR.

	The respondent and Agency labor costs have also increased.  Also, while
the previous ICR used only a technical rate, Tables 1 and 2 of this ICR
reflect burden and cost calculations expanded to include managerial and
clerical labor rates.

6(g)  Burden Statement

The annual public reporting and recordkeeping burden for this collection
of information is estimated to average 214 hours per response.  Burden
means the total time, effort, or financial resources expended by persons
to generate, maintain, retain, or disclose or provide information to or
for a Federal agency.  This includes the time needed to review
instructions; develop, acquire, install, and utilize technology and
systems for the purposes of collecting, validating, and verifying
information, processing and maintaining information, and disclosing and
providing information; adjust the existing ways to comply with any
previously applicable instructions and requirements; train personnel to
be able to respond to a collection of information; search data sources;
complete and review the collection of information; and transmit or
otherwise disclose the information.

An agency may not conduct or sponsor, and a person is not required to
respond to, a collection of information unless it displays a valid OMB
Control Number.  The OMB Control Numbers for EPA regulations are listed
at 40 CFR part 9 and 48 CFR chapter 15.

	To comment on the Agency's need for this information, the accuracy of
the provided burden estimates, and any suggested methods for minimizing
respondent burden, including the use of automated collection techniques,
EPA has established a public docket for this ICR under Docket ID Number
EPA-HQ-OECA-2009-0528.  An electronic version of the public docket is
available at http://www.regulations.gov/ which may be used to obtain a
copy of the draft collection of information, submit or view public
comments, access the index listing of the contents of the docket, and to
access those documents in the public docket that are available
electronically.  When in the system, select “search,” then key in
the docket ID number identified in this document.  The documents are
also available for public viewing at the Enforcement and Compliance
Docket and Information Center in the EPA Docket Center (EPA/DC), EPA
West, Room 3334, 1301 Constitution Avenue, N.W., Washington, D.C.  The
EPA Docket Center Public Reading Room is open from 8:30 a.m. to 4:30
p.m., Monday through Friday, excluding legal holidays.  The telephone
number for the Reading Room is<PHONE_NUMBER>, and the telephone number
for the docket center is<PHONE_NUMBER>.  Also, you can send comments to
the Office of Information and Regulatory Affairs, Office of Management
and Budget, 725 17th Street, N.W., Washington, DC 20503, Attention: Desk
Officer for EPA.  Please include the EPA Docket ID Number
EPA-HQ-OECA-2009-0528 and OMB Control Number 2060-0072 in any
correspondence.

Part B of the Supporting Statement

This part is not applicable because no statistical methods were used in
collecting this information.Table 1: Annual Respondent Burden and Cost
- NSPS for Industrial-Commercial-Institutional Steam Generating Units
(40 CFR Part 60, Subpart Db)

Reporting and recordkeeping requirements	A

Person hours per occurrence	B

Annual occurrences per respondent	C

Annual person hours per respondent

(A x B)	D

Total number of respondents	E

Technical person hours  a	F

Clerical person hours  a	G

Manage-ment person hours  a	H

Total annual person hours

(C x D)	I

Total annual cost

1. Applicants	N/A

2. Survey and Studies	N/A

3. Reporting Requirements  b

A. Read Instructions  c	see 4A	 	 	 	 	 	 	   =sum (below)
12,770

B. Required Activities

Initial Performance Test:

PM  b	330	1	330	19	5,452.17	545.22	272.61	6,270	$589,677

24 hour test for Gas Units  c	250	1	250	26	5,652.17	565.22	282.61	6,500
$611,308

Repeat of Performance Test:

PM  b,  d	330	1	330	4	1,147.83	114.78	57.39	1,320	$124,143

24 hour tests for Gas Units  c,  d	250	1	250	5	1,086.96	108.70	54.35
1,250	$117,559

Report of Initial Performance Test:  c

SO2	16	1	16	13	180.87	18.09	9.04	208	$19,562

PM	16	1	16	19	264.35	26.43	13.22	304	$28,590

NOx	16	1	16	45	626.09	62.61	31.30	720	$67,714

Notification of CEMS Demonstration  c

SO2	2	1	2	13	22.61	2.26	1.13	26	$2,445

PM	2	1	2	19	33.04	3.30	1.65	38	$3,574

NOx	2	1	2	45	78.26	7.83	3.91	90	$8,464

Demonstration of CEMS  c

SO2	150	1	150	13	1,695.65	169.57	84.78	1,950	$183,392

PM	100	1	100	19	1,652.17	165.22	82.61	1,900	$178,690

NOx	350	1	350	45	13,695.65	1,369.57	684.78	15,750	$1,481,246

Repeat Demonstration of CEMS  c,  d

SO2	150	1	150	3	391.30	39.13	19.57	450	$42,321

PM	100	1	100	4	347.83	34.78	17.39	400	$37,619

NOx	350	1	350	9	2,739.13	273.91	136.96	3,150	$296,249

Report of CEMS Demonstration  c	See 3B

Reports for SO2  e

Quarterly  f	16	4	64	148	8,236.52	823.65	411.83	9,472	$890,817

Semiannual	16	2	32	593	16,500.87	1,650.09	825.04	18,976	$1,784,643

Reports for PM  e,  g

Quarterly:  f

Excess	16	4	64	38	2,114.78	211.48	105.74	2,432	$228,723

No Excess	8	4	32	152	4,229.57	422.96	211.48	4,864	$457,447

Semiannual:

Excess	16	2	32	177	4,925.22	492.52	246.26	5,664	$532,684

No Excess	8	2	16	570	7,930.43	793.04	396.52	9,120	$857,712

Reports for NOx  e,  g

Quarterly:  f

CEMS Compliance	16	4	64	162	9,015.65	901.57	450.78	10,368	$975,083

Excess	16	4	64	33	1,836.52	183.65	91.83	2,112	$198,628

No Excess	8	4	32	129	3,589.57	358.96	179.48	4,128	$388,228

Semiannual:

CEMS Compliance	16	2	32	647	18,003.48	1,800.35	900.17	20,704	$1,947,157

Excess	16	2	32	129	3,589.57	358.96	179.48	4,128	$388,228

No Excess	8	2	16	518	7,206.96	720.70	360.35	8,288	$779,465

Appendix F Report  e,  h

Quarterly:  f

SO2	11	4	44	130	4,973.91	497.39	248.70	5,720	$537,951

NOx	11	4	44	171	6,542.61	654.26	327.13	7,524	$707,613

Semiannual:

SO2	11	2	22	514	9,833.04	983.30	491.65	11,308	$1,063,488

NOx	11	2	22	685	13,104.35	1,310.43	655.22	15,070	$1,417,294

Annual Compliance Tests for NOx  e	250	1	250	372	80,869.57	8,086.96
4,043.48	93,000	$8,746,407

Appendix F Annual Accuracy Test:  e, h

SO2	36	1	36	856	26,796.52	2,679.65	1,339.83	30,816	$2,898,164

NOx	36	1	36	644	20,160.00	2,016.00	1,008.00	23,184	$2,180,395

Appendix F Audits  e,  i,  j

Quarterly

SO2 - In Situ	125	4	500	33	16,500.00	0.00	0.00	16,500	$825,000

SO2 – Extractive	36	4	144	97	13,968.00	0.00	0.00	13,968	$698,400

Semiannual

SO2 - In Situ	125	2	250	129	32,250.00	0.00	0.00	32,250	$1,612,500

SO2 - Extractive	36	2	72	385	27,720.00	0.00	0.00	27,720	$1,386,000

Quarterly

NOx - In Situ	125	4	500	43	21,500.00	0.00	0.00	21,500	$1,075,000

NOx - Extractive	36	4	144	128	18,432.00	0.00	0.00	18,432	$921,600

Semiannual

NOx - In Situ	125	2	250	171	42,750.00	0.00	0.00	42,750	$2,137,500

NOx - Extractive	36	2	72	514	37,008.00	0.00	0.00	37,008	$1,850,400

C. Create Information  c	Included in 3B

D. Gather Existing Information	Included in 3B

E. Write Report

Notify of Construction/
Reconstruction  c	2	1	2	45	78.26	7.83	3.91	90	$8,464

Notify of Anticipated Startupc	2	1	2	45	78.26	7.83	3.91	90	$8,464

Notify of Actual Startup  c	2	1	2	45	78.26	7.83	3.91	90	$8,464

Monitoring Plan  c	4	1	4	22	76.52	7.65	3.83	88	$8,276

Notification of Initial Performance Test  c

SO2	2	1	2	13	22.61	2.26	1.13	26	$2,445

PM	2	1	2	19	33.04	3.30	1.65	38	$3,574

NOx	2	1	2	45	78.26	7.83	3.91	90	$8,464

Total Reporting Burden

537,844	$41,327,235

4. RECORDKEEPING REQUIREMENTS

A. Read Instructions  c	1	1	1	45	39.13	3.91	1.96	45	$4,232

B. Plan Activities	N/A

C. Implement Activities	N/A

D. Develop Record System	N/A

E. Time to Enter Information

F. Records of Startup, Shutdown,                            Malfunction
1.5	52	78	1,500	101,739.13	10,173.91	5,086.96	117,000	$11,003,545

G. Records of All Measurements	1.5	52	78	1,500	101,739.13	10,173.91
5,086.96	117,000	$11,003,545

Total Recordkeeping Burden	 	 	 	 	 	 	 	234,045	22,011,322

TOTAL ANNUAL BURDEN	 	 	 	 	 	 	 	771,889	63,338,557

Footnotes:

a) This ICR uses the following labor rates: Managerial $114.77 ($54.65 +
110%); Technical $97.59 ($46.47 + 110%); and Clerical $48.26 ($22.98 +
110%).  These rates are from the United States Department of Labor,
Bureau of Labor Statistics, March 2009, Table 2. Civilian Workers, by
occupational and industry group.  The rates are from column 1, "Total
compensation."  The rates have been increased by 110 percent to account
for the benefit packages available to those employed by private
industry.  This ICR assumes that Managerial hours are 5 percent of
Technical hours, and Clerical hours are 10 percent of Technical hours.

b) EPA estimates that there will be 26 new gas-fired steam generating
units per year (which require NOx controls), 13 new coal-fired
generating units per year (which require SO2, NOx, and PM controls), and
6 new biomass/wood (which require NOx and PM controls).

c) One-time only costs associated with the anticipated 45 new sources
per year over the next three years.  According to the 2003 ICR renewal,
approximately half of all new sources will submit a monitoring plan.

d) Assume 20 percent of initial performance tests and CEMS
demonstrations are repeated due to failures.

e) According to the 2003 ICR renewal, there are 640 sources that must
report SO2 emissions,  622 sources that must report PM emissions, and
1322 sources that must report NOx emissions.  Because these existing
source estimates were from 2003, this ICR renewal adds 270 additional
existing sources since the 2003 ICR renewal (45 sources times six years)
to update the total number of existing sources reported each type of
pollutant.  These 270 sources are split out according to the same
distribution of gas, coal, and biomass units listed in note (b) above.
To estimate the total number of respondents for each type of pollutant
reporting, the existing sources subject to each type of pollutant
reporting were added to the 45 new sources per year and these new
sources were distributed according to note (b).

f) Assume that 20 percent of respondents will choose to report
quarterly.

g) Assume the 20 percent of units are found to be in excess of emission
standard, 80 percent are found to be in no excess.

h) According to the 2003 ICR renewal, 57 percent of all sources submit
an Appendix F Report for SO2, and the remaining 43 percent submit an
Appendix F Report for NOx.

i) Appendix F audit costs are based on contractor costs of $50.00 per
hour.

j) Assume that 25 percent of units have in situ CEMS and 75 percent have
extractive CEMS.

Table 2: Annual Agency Burden and Cost - NSPS for
Industrial-Commercial-Institutional Steam Generating Units (40 CFR Part
60, Subpart Db)

Activity	A

EPA hours per occurrence	B

Occurrences per plant per year	C

EPA hours per plant per year

(A x B)	D

Plants per year	E

Technical person hours  a	F

Clerical person hours  a	G

Management person hours  a	H

EPA hours per year

(C x D)	I

Total annual cost

Report Review For Construction, Anticipated Startup, Actual Startup  b
116	1	116	45	4,539	454	227	5,220	$231,732

Review Notification of Initial Test:

SO2  c	70	1	70	13	791	79	40	910	$40,398

PM  c	72	1	72	19	1,190	119	59	1,368	$60,730

NOx  c	104	1	104	45	4,070	407	203	4,680	$207,759

Review Initial Test Results:

SO2  c	280	1	280	13	3,165	317	158	3,640	$161,591

PM  c	288	1	288	19	4,758	476	238	5,472	$242,919

NOx  c	416	1	416	45	16,278	1,628	814	18,720	$831,038

Review Notification of CMS Demonstration:

SO2  c	56	1	56	13	633	63	32	728	$32,318

PM  c	82	1	82	19	1,355	135	68	1558	$69,164

NOx  c	42	1	42	45	1,643	164	82	1,890	$83,903

Review CMS Performance Demonstration:

SO2  c	448	1	448	13	5,064	506	253	5,824	$258,545

PM  c	656	1	656	19	10,838	1,084	542	12,464	$553,315

NOx  c	336	1	336	45	13,148	1,315	657	15,120	$671,223

Review Monitoring Plan  b	108	1	108	22	2,066	207	103	2,376	$105,478

Review NOx Compliance Reports  d,  e

Quarterly	42	4	168	162	23,666	2,367	1,183	27,216	$1,208,201

Semiannual	42	2	84	647	47,259	4,726	2,363	54,348	$2,412,673

Review SO2 Compliance Reports  d,  e

 	0	0	0

Quarterly	70	4	280	148	36,035	3,603	1,802	41,440	$1,839,648

Semiannual	70	2	140	593	72,191	7,219	3,610	83,020	$3,685,510

Review Excess Emissions Reports:  d,  e

SO2:

Quarterly	130	4	520	148	36,035	3,603	1,802	41,440	$1,839,648

Semiannual	130	2	260	593	72,191	7,219	3,610	83,020	$3,685,510

NOx:

Quarterly	92	4	368	33	10,560	1,056	528	12,144	$539,109

Semiannual	92	2	184	129	20,640	2,064	1,032	23,736	$1,053,713

Review Appendix F QA Data Assessment Reports:  d

SO2	42	1	42	644	23,520	2,352	1,176	27,048	$1,200,743

NOx	56	1	56	856	41,683	4,168	2,084	47,936	$2,128,025

SUBTOTAL

 	 	 	 	462,638	$27,878,743

Travel Expenses  f	 	 	 	 	 	 	 	 	$7,125

TOTAL ANNUAL COST	 	 	 	 	 	 	 	 	$27,855,868

Footnotes:

a) This ICR uses the following labor rates: Managerial $61.36 (GS-13,
Step 5, $38.35 + 60%); Technical $45.52 (GS-12, Step 1, $28.45 + 60%);
and Clerical $24.64 (GS-6, Step 3, $15.40 + 60%).

These rates are from the Office of Personnel Management (OPM), 2009
General Schedule, which excludes locality rates of pay.  The rates have
been increased by 60 percent to account for the benefit packages
available to government employees.  This ICR assumes that Managerial
hours are 5 percent of Technical hours, and Clerical hours are 10
percent of Technical hours.

b) All new plants subject to the standard must provide reports of these
events as required by section 60.7.  These are one-time-only costs
associated with the anticipated 45 new sources per year over the next
three years.  According to the 2003 ICR renewal, approximately half of
all new sources will submit a monitoring plan.

c) EPA estimates that there will be 26 new gas-fired steam generating
units per year (which require NOx controls), 13 new coal-fired
generating units per year (which require SO2, NOx, and PM controls), and
6 new biomass/wood (which require NOx and PM controls).

d) The average number of new sources for each control for SO2, PM and
NOx have been determined according to assumption (b) in Table 1 above,
accounting for industry growth during the years since the ICR renewal of
the year 2003, and added to the number of existing sources required to
submit reports for each type of pollutant.  The estimates for the number
of existing sources are in note (e) of Table 1 above.

e) We assume that 20 percent of respondents will choose to report
quarterly.

f) Travel expenses (1 person x 15/plants/yr x 3 days/plant x $75 per
diem) + ($250 round trip/plant x 15 plants/yr).

 PAGE

 PAGE  23

 PAGE


[Federal Register Volume 77, Number 214 (Monday, November 5, 2012)]
[Notices]
[Page 66497]
[FR Doc No: 2012-26909]

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

SECURITIES AND EXCHANGE COMMISSION

[Release No. 34-68112; File No. SR-OCC-2012-14]

 Self-Regulatory Organizations; The Options Clearing Corporation;
Notice of Designation of a Longer Period for Commission Action on
Proposed Rule Change Relating to the Clearance and Settlement of Over-
the-Counter Options

October 26, 2012.
    On August 30, 2012, the Options Clearing Corporation (``OCC'')
filed with the Securities and Exchange Commission (``Commission'') the
proposed rule change and Advance Notice SR-OCC-2012-14 pursuant to
Section 19(b)(1) of the Securities Exchange Act of 1934 (``Act'') \1\
and Rule 19b-4 thereunder.\2\ The proposed rule change was published
for comment in the Federal Register on September 18, 2012 \3\ and an
Advance Notice was published for comment in the Federal Register on
September 27, 2012.\4\
---------------------------------------------------------------------------

    \1\ 15 U.S.C. 78s(b)(1).
    \2\ 17 CFR 240.19b-4.
    \3\ Securities Exchange Act Release No. 67835 (September 12,
2012), 77 FR 57602 (September 18, 2012).
    \4\ Securities Exchange Act Release No. 67906 (September 21,
2012), 77 FR 59431 (September 27, 2012).
---------------------------------------------------------------------------

    Section 19(b)(2) of the Act \5\ provides that within 45 days of the
public of notice of the filing of a proposed rule change, or within
such longer period up to 90 days as the Commission may designate if it
finds such longer period to be appropriate and publishes its reasons
for so finding or as to which the self-regulatory organization
consents, the Commission shall either approve the proposed rule change,
disapprove the proposed rule change, or institute proceedings to
determine whether the proposed rule change should be disapproved. The
45th day for this filing is November 2, 2012. The Commission is
extending this 45 day time period.
---------------------------------------------------------------------------

    \5\ 15 U.S.C. 78s(b)(2).
---------------------------------------------------------------------------

    The proposed rule change relates to OCC's adoption of rules to
permit the clearing of Over-the-Counter (``OTC'') options on the S&P
500 Index. In light of the fact that OCC does not currently provide
clearing services for OTC products and because no registered clearing
agency currently provides clearing services for OTC S&P 500 Index
options, the Commission finds it is appropriate to designate a longer
period within which to take action on the proposed rule change so that
it has sufficient time to consider this proposed rule change.
    Accordingly, the Commission, pursuant to Section 19b(b)(2) of the
Act,\6\ designates December 17, 2012, as the date by which the
Commission should either approve or disapprove, or institute
proceedings to determine whether to disapprove, the proposed rule
change (File No. SR-OCC-2012-14).
---------------------------------------------------------------------------

    \6\ 15 U.S.C. 78s(b)(2).

    For the Commission by the Division of Trading and Markets,
pursuant to delegated authority.\7\
---------------------------------------------------------------------------

    \7\ 17 CFR 200.30-3(a)(12).
---------------------------------------------------------------------------

Kevin M. O'Neill,
Deputy Secretary.
[FR Doc. 2012-26909 Filed 11-2-12; 8:45 am]
BILLING CODE 8011-01-P


donor for reentry.
The data that we saw presented at the June, 2001
Blood Products Advisory Committee meeting demonstrated that
a six-month follow-up period encompasses the pre-
seroconversion window period with sufficient confidence
that a negative HCV serology test, after at least six
months have passed, rules out HCV infection.
[Slide]
Therefore, for purposes of reentry we are
considering recommending that a follow-up sample be taken
after a minimum time period of six months for follow-up
testing of the donor by both a licensed HCV NAT and a
licensed anti-HCV EIA.  If both the NAT and EIA tests on
the follow-up sample are negative, the donor may be
reentered, that is, would be eligible for future donation.
So, I think I will stop there and take any
questions you might have.  Yes, Dr. Schochetman?
DR. SCHOCHETMAN:  Gerry Schochetman.  I just
wanted to mention a case we came across of somebody who was
HIV EI positive and full-blown Western Blot positive but
RNA negative by multiple tests.  The only way we were able

sgg
MILLER REPORTING COMPANY, INC.
735 8th Street, S.E.
Washington, D.C. 20003-2802
(202) 546-6666
to confirm that was by collecting some PBMCs and showing
that there was a low level of proviral DNA, which we could
sequence and show that the individual was a subtype B.  So,
there may be another kind of case where somebody may be
continuously NAT RNA negative but could actually be
infected.
DR. MEID:  Right.  Of course, those donors would
not be reenterable because of the persistent antibody.
DR. EPSTEIN:  Now we are going to expand the
perspective to look across the pond and hear a talk from
Micha Nubling, from the Paul Ehrlich Institute, also on
regulatory issues and perspectives.  Thank you very much.
Paul Ehrlich Institute and European Union Views
[Slide]
DR. NUBLING:  First of all, I would like to thank
the organizers for the opportunity to speak here and to
present the views of PEI.  I will also present the views of
the EU on plasma derivatives.  Glenda Sylvester was invited
as well but couldn't come and, therefore, I took over her
presentation as well.
[Slide]
Blood components are estimated as drugs according
to the German Drug Rule and, therefore, respective
regulations are possible and the responsible party is the
PEI.  Several years ago, or two years ago, HCV-NAT was

sgg
MILLER REPORTING COMPANY, INC.
735 8th Street, S.E.
Washington, D.C. 20003-2802
(202) 546-6666
introduced.  I will cover this shortly.  Then I will go to
comparative studies concerning HCV co-antigen.  The
question was if this assay could replace or substitute at
least HCV NAT.  Then I will come shortly to HIV and our
plans to introduce this also as screening for whole blood
components in Germany.
[Slide]
This is already history.  The regulation for
blood components HCV NAT was introduced as a screening test
for erythrocytes and thrombocytes and later also for
seropoeitic plasma by PEI, already in April of 1999.  At
this time we defined a sensitivity limit which was to be
fulfilled of 5000 international units per milliliter and
this was to be controlled by run controls.  Pooling, of
course, was possible with this requirement and, at this
time, there was no commercial assay available so also in-
house tests were to be accepted as long as they fulfilled
validation requirements, which we defined also at PEI.
The meantime experience with this requirement is
that it is feasible, but we also have to say that the
experience benefit is somewhat lower than expectations
based on incidence data which I provided two years ago.
But I also have to say that the basis for the incidence
data is quite different in some blood banks where repeat

sgg
MILLER REPORTING COMPANY, INC.
735 8th Street, S.E.
Washington, D.C. 20003-2802
(202) 546-6666
reactive donations go into incidence calculations.  This
might also be a reason for this discrepancy.
[Slide]
In numbers, we have had a recent presentation
from Prof. Seifried and Hitzler at the IABS meeting with
the most recent data, and we see some discrepancy between
different organizations which collect blood in Germany.
The smaller donations and less associated with universities
or small hospitals have a higher frequency of NAT only
positive donations, approximately 7.3 per million, while
the Red Cross blood donations have quite a lower frequency,
approximately a factor of ten.  This is probably due to
different populations, donor populations because these
donor populations came mainly from cities while the Red
Cross blood donations cover mainly rural areas in Germany.
We have also addressed incidence.  Viral
transmissions have to be reported to EPI by an installed
reporting system, and since this NAT regulation has been in
place there has been no adverse incidence reported of HCV
transmission by blood.
[Slide]
So, this is the experience and the benefit which
is obtained in the meantime.  Approximately three years ago
the antibody to HCV for antigen ELISA became available and
immediately the question was if this test could be used

sgg
MILLER REPORTING COMPANY, INC.
735 8th Street, S.E.
Washington, D.C. 20003-2802
(202) 546-6666
also for screening in addition to HCV NAT or even replacing
HCV NAT, and I just want to summarize some studies we have
performed in this respect.
We had access to 52 follow-ups of the very early
infection phase, similar to the follow-ups Michael Busch
already reported, covering in total nearly 500 anti-HCV
negative window phase samples.  We analyzed all these
samples by different NAT methods and also by the core
antigen and also we genotyped the different panels.  I
would like to shortly summarize the data.
[Slide]
In blue you always see the core antigen ELISA.
Here is the cut-off value.  In red is the HCV RNA.  So,
here is the run-up phase, as was already introduced by
Michael Busch.  We see it as parallel HCV detection in 10
out of the 52 panels where there is no difference between
these two assays.  So, the first PCR positive assay sample
is also antigen positive.  This was for 10 of 52 panels.
[Slide]
For 21 of 52 panels we see the following pattern,
also represented by only one panel, of course.  There is a
delay of antigen detection, approximately one week.  Later
on there is a consistent detection of HCV RNA and core
antigen.  We also see these blips or these low titer
viremia samples in many of these panels.

sgg
MILLER REPORTING COMPANY, INC.
735 8th Street, S.E.
Washington, D.C. 20003-2802
(202) 546-6666
[Slide]
The last pattern which I want to share with you
is fluctuating antigen detection.  Again, there is a steep
increase in HCV RNA and the second sample is also core
antigen positive.  But later on there is again a decrease
in HCV RNA titer and this is followed by core antigen
negative results and borderline results.  This pattern we
see in 9 out of 52 panels.
[Slide]
So, summarizing these data again, the red columns
represent the severe RNA.  The blue columns represent core
antigen.  We have grouped the different columns in respect
to increasing HCV RNA titers.  We see immediately that the
high titer RNA samples are also detected by the core
antigen test very consistently, but approximately at 10
5
units per milliliter and lower the core antigen test
becomes negative while NAT remains positive.
I have to admit that with the requirement which
is in place in Germany there would also be certain low
titer samples missed.  This are the blip samples again.  A
few low titer samples would be missed and, therefore, it is
under discussion if this sensitivity requirement should be
changed to higher sensitivity.  We can also calculate the
HCV RNA doubling time.  It is a slightly different figure
compared to Michael Busch's but maybe the analysis did not

sgg
MILLER REPORTING COMPANY, INC.
735 8th Street, S.E.
Washington, D.C. 20003-2802
(202) 546-6666
use the same panels and not the same algorithm.  With this
HCV RNA doubling time during the virus burst we can also
calculate effects.  If the sensitivity requirement is, for
example, changed to 2500 we would approximately get ten or
less of the diagnostic window phase.
[Slide]
Infectivity of low titer HCV RNA transfusion has
already been mentioned by Michael Busch.  There are
different applications compared to ours, and Schutler was
also recognized before.  There are some examples which at
least could be the basis for the concern that blip
donations or low titer donations are, indeed, infectious.
[Slide]
Summarizing this study, our conclusions are that
the HCV core assay protects, indeed, the majority of the
window phase donations but not all, and for a country which
already has NAT regulations in place with a higher
sensitivity, it is not easy to substitute HCV NAT by such
an assay.  So, the sensitivity of the core assay is lower
compared to our regulation at the moment.  We know that
there is a second version of the core antigen assay
available which is much more sensitive and the question, of
course, reappears.  For low titer viremic samples, like the
blip samples, RNA concentration on a single donation NAT
would detect these samples.

sgg
MILLER REPORTING COMPANY, INC.
735 8th Street, S.E.
Washington, D.C. 20003-2802
(202) 546-6666
[Slide]
I come to the second topic, HIV-NAT.  We had the
recent experience in the last three years of transmission
of HIV to recipients of blood transfusions in four
documented cases.  So, window phase donations were the
cause for transmission of the virus, and we analyzed these
cases retrospectively and three of them were p24 antigen
negative.  One was p24 antigen positive.  But all of these
donations had virus titers which would be easily detected
by even minipool or pooled NAT.  Three other donations have
already been identified during this period by NAT, which is
applied on a voluntary basis already by many of the blood
donation centers in Germany.
[Slide]
The further background concerning HIV-NAT in
Germany, the plasma industry already requires plasma tests
for HIV RNA.  Therefore, at least the major blood donations
have already introduced HIV RNA testing.  So, 75 percent of
the donations are already covered.  The reason for
transmissions would have been prevented by HIV-NAT on
minipools.
[Slide]
As a consequence of this, we are discussing now
introduction of HIV NAT for the next year.  This should
cover the cellular blood components as well plasma.  The

sgg
MILLER REPORTING COMPANY, INC.
735 8th Street, S.E.
Washington, D.C. 20003-2802
(202) 546-6666
proposed sensitivity in this case is 10,000 international
units per milliliter which corresponds approximately to
5000 copies per milliliter.  This should come in place
during the next year.  Again, we will accept validated in-
house methods or commercial NAT methods which have been
approved by EPI.  In the time being we are performing a
collaborative study on in-house NAT assays, which will be
finished in December of this year, or during this month.
We have now 19 different in-house assays, similar in-house
assays which participate in this study which are performed
in blood donation centers and for HCV, 22.  So, there is
quite a high range of those assays already performed.
[Slide]
Again, the RNA titers are increased during the
window phase of HIV.  We see that if we would rely on the
p24 antigen assay only at the high titer, RNA donations
would be detected by p24, and by this proposed sensitivity
requirement we would close the window by approximately
three to four days compared to the situation if we would
introduce p24.  So, this is the current situation.  There
is some delay.  The RNA doubling time for HIV is 21 hours
and one can calculate the effect of increasing sensitivity
on this basis.
[Slide]

sgg
MILLER REPORTING COMPANY, INC.
735 8th Street, S.E.
Washington, D.C. 20003-2802
(202) 546-6666
There are many discussions in Germany concerning
royalties for screening markers of NAT and these
discussions also are the basis for certain delays in the
introduction of NATs in different countries.  First of all,
the royalties are to be paid for single donation.  This is
in principle also supported by EPI because with this
requirement we can get rid of the bigger pool sizes because
it is not much more cost effective compared to single
donation or small pool sizes.
On the other hand, in our estimation the size of
the royalties is difficult to justify.  Nobody has any
questions about royalties in principle but if you compare
the size of the royalties to the royalties which have to be
paid for anti-HCV assays, there is a lot of benefit
compared to the introduction of HCV NAT and there are not
very good arguments, at least if this is compared.
Furthermore, there are some feelings in Europe
that NAT manufacturers didn't contribute too much to the
introduction of HCV NAT and the major work was done by
blood donation centers and plasma manufacturers in the
past, and now that the feasibility has been shown these
manufacturers jumped on and tried to get what they can get.
Also, I have to say that from a regulatory point
of view royalties which are not expectable or at least the
sizes are not clearly expectable provide less room for

sgg
MILLER REPORTING COMPANY, INC.
735 8th Street, S.E.
Washington, D.C. 20003-2802
(202) 546-6666
future regulatory decisions because we also have to keep in
mind cost and benefit.
[Slide]
The current situation in Europe, and this is not
the EU only, is that HCV NAT has been introduced in
different countries like France, Germany,  Switzerland,
Austria, United Kingdom, Norway and Finland but in many of
these countries only on a study basis.  So, it is not a
permanent regulatory requirement.  Several countries also
allow HCV NAT or HCV antigen testing, like in Italy or
Spain and in Poland, for example, only HCV antigen is used
for screening of blood donations.  So, there is quite a
diffuse picture around Europe, and this picture will
probably change also based on the outcome of these royalty
discussions.
Concerning HIV NAT, this has already been
introduced in France, Austria and The Netherlands in the
past and, as I already said, in Germany we expect an
introduction during the next year.
[Slide]
I come now to viral safety of plasma-derived
medicinal products, and this is the presentation which I
currently got from Glenda Silvester, from the European
Medicines Evaluation Agency, in London, which is
responsible for respective regulations.

sgg
MILLER REPORTING COMPANY, INC.
735 8th Street, S.E.
Washington, D.C. 20003-2802
(202) 546-6666
[Slide]
The current situation for plasma-derived
medicinal products is effective treatment and prophylaxis,
prophylaxis of conditions causing morbidity and mortality
possible with these products.  The viral safety has been
achieved at a high level for blood-borne viruses, HIV, HCV
and HBV, and for other safety problems they have been
minimized.  For example, formation of inhibitors which has
been a topic two years ago approximately.  There is also a
sufficient supply of these products so, in total, there is
a favorable benefit to risk balance.
[Slide]
You know all the different points with the
current level of safety of plasma-derived medicinal
products has been achieved.  It starts with donor
selection, with testing of donations and, therefore, the
different viruses, testing for HCV RNA and inactivation
procedures, GMP and also antibodies present for some of the
viruses which have a certain impact on safety.  So, in
total we can conclude inactivation and removal procedures,
together with GMP, provide better protection for unknown
and new viruses as well and, once identified, testing can
target the specific viruses and minimize the load on the
manufacturing process.
[Slide]

sgg
MILLER REPORTING COMPANY, INC.
735 8th Street, S.E.
Washington, D.C. 20003-2802
(202) 546-6666
This specific testing has already been introduced
for HCV.  The requirement for pool testing for HCV RNA is
now in place since July, '99.  And, pools must have to be
non-reactive and a run control of 100 international units
must be detected in a parallel test.
[Slide]
This has also found place in the European
monograph for human plasma for fractionation.  So,
validation of assays is mentioned there.  The internal
control to test for inhibitors is prescribed there as the
representing state-of-the-art, and guidelines on validation
of NAT have been defined.
[Slide]
I would just like to share with you our
experience with this regulation at EPI.  We still use the
Amplicor HCV in a validated version for retesting also
plasma pools which have been pretested by the manufacturer
and are now, by definition, negative for HCV RNA.  In the
meantime, since this regulation was in place we have tested
more than 5000 pools and in this big size of pools there
was no repeatedly HCV NAT positive pool identified.  I am
sure others who have performed similar retesting have a
similar experience.  So, this requirement is now the basis
for, let's say, many discrepant results.
[Slide]

sgg
MILLER REPORTING COMPANY, INC.
735 8th Street, S.E.
Washington, D.C. 20003-2802
(202) 546-6666
Last September, September of last year the EMEA
workshop on viral safety of plasma-derived medicinal
products was held with a particular focus on non-envelope
viruses.  I would just like to share with you the
conclusions of this workshop.
[Slide]
First of all, it was again stated that there is
an excellent safety for envelope viruses and no need has
been seen for a regulatory approach for HIV or HBV NAT to
be introduced for plasma testing.  Development of improved
inactivation and removal steps for a number of envelope
viruses, on the other hand, remains an objective for all
plasma-derived medicinal products and effective steps need
to be implemented for all coagulation factors.
Concerning hepatitis A virus, this was also
discussed at this workshop.  The conclusion was that NAT
testing of plasma pools should not be introduced for HAV
RNA because of low titer to be expected in plasma pools and
because of the experience that screening or testing of
plasma pools for hepatitis A virus RNA did not prevent
transmission of this virus by Factor VIII preparation in
the past.  This was approximately two years ago.
[Slide]

sgg
MILLER REPORTING COMPANY, INC.
735 8th Street, S.E.
Washington, D.C. 20003-2802
(202) 546-6666
A further topic was parvovirus B19, and there are
two aspects of parvovirus B19 transmission itself and also
vulnerability to unknown envelope viruses.
[Slide]
First of all, consequences of parvovirus B19
transmission are normally harmless.  It is a common
infection and we very seldom see problems associated with
it, but there are certain risk groups where problems can
occur and these are patients with hemolytic disorders,
immunocompromised patients and also pregnant women where
the fetus can be infected and cause harm.
[Slide]
Concerning safety approaches for parvovirus B19,
heat treatment of lyophilized products has been shown not
to be very effective for this virus.  The same is true for
nanofiltration.  This has some effect but not a very
efficient effect and new techniques are still in
development to inactivate or remove parvovirus B19.
On the other hand, we have neutralizing
antibodies in immunoglobulins and S/D plasma, nevertheless,
high titer parvoviruses may not be neutralized any longer
by the presence of these antibodies as a certain incidence
has shown.  NAT for parvovirus B19 may reduce the virus
load during the process and complement other safety
measures.

sgg
MILLER REPORTING COMPANY, INC.
735 8th Street, S.E.
Washington, D.C. 20003-2802
(202) 546-6666
[Slide]
The conclusions on parvovirus were inactivation
and removal is currently different.  Some approach can give
limited inactivation or removal depending on product and
process, and NAT testing of minipools can be estimated as a
complementary measure for inactivation and removal, but the
impact of this measure has to be proven with respect to
virus safety.  There is no final proof, at least up till
now.
[Slide]
The introduction of inactivation or removal steps
such as NAT -- there are complementary measures such as NAT
should be prioritized for coagulation factors and
solvent/detergent-treated plasma because of reports of
proven transmissions by these products, and for NAT
immunoglobulin because of use in high risk patient groups
and pregnant women.
[Slide]
There is already a draft now out for discussion
in the Pharmaeuropa which proposes that the production of
NAT immunoglobulin, that plasma pools should be tested for
parvovirus and the maximum limit has been proposed for 10
4
international units per milliliter of or RNA in plasma
pools.  So, any concentration lower than this is accepted
but higher concentration should be avoided.  This is still

sgg
MILLER REPORTING COMPANY, INC.
735 8th Street, S.E.
Washington, D.C. 20003-2802
(202) 546-6666
out for comments but this is the first approach in Europe


December 4, 2009

Mr. Vincent Camobreco

U.S. Environmental Protection Agency

Ariel Rios Building

1200 Pennsylvania Avenue, N.W.

Washington, D.C. 20460

Submitted electronically

Subject: FASOM Sensitivity Analysis to Distillers Grains Assumptions

Dear Vince,

As you are aware, distillers grains from corn ethanol plants can have a
significant impact on the net amount of land required to produce corn
for ethanol and other markets. FASOM, the model used by EPA to estimate
domestic land use changes for the RFS2 analysis, assumes that 1 lb of
distillers grains replaces 1 lb of feed, where the replaced feed is
0.915 lbs of corn and 0.085 lbs of soybean meal. Our comments on the
proposed rule show that, based on information from the feed industry,
nutritionists and Argonne National Laboratory, the replacement rates are
higher than assumed in FASOM.

We carefully examined the proposed RFS2 rule for any evidence that EPA
evaluated FASOM’s predictions of corn and soybean meal production and
their sensitivity to the distillers grains feed replacement assumptions,
but found no sensitivity analyses. Therefore, we asked Air Improvement
Resource, Inc. (AIR) to run sensitivity analysis of FASOM results to
three different DG input assumptions, as follows:

“Default” DG assumptions (same as EPA)

“Zero DGs” (i.e., DGs do not replace feed at all)

“RFA DGs” (i.e., DGs replace corn and soybean meal at rates
recommended by Prof. Gerald Shurson, University of Minnesota)

The results of this analysis are shown in the attached briefing slides.
Basically, there are three findings from this analysis:

1.	The model shows that DG use does reduce land devoted to soybeans, and
also reduces soybean production.

2.	The model shows that DG use does reduce land devoted to corn, but for
some unidentifiable reason, does not reduce corn production.

3.	The model does not reduce corn and soybean acreage in response to
increased DG displacement to the degree our external calculations
suggest should reasonably occur. The reasons for this are not clear.

Since DGs have a significant effect on net land use for corn ethanol, we
think these FASOM modeling issues should be carefully examined by EPA
before finalizing the RFS2. While the directional effects of increasing
DG substitution inside the FASOM model appear correct, the magnitude of
the effects appears grossly understated. The reasons for this should be
investigated. Based on the apparent gross understatement of the land
impact of increasing DG substitution, it appears the FASOM model may
possibly be flawed in how it translates changes in DG substitution rates
into acreage impacts.

If you have any questions on our analysis, we would be glad to meet with
you to go over these results.

Respectfully yours,

Geoff Cooper

VP, Research & Analysis


[Federal Register Volume 83, Number 90 (Wednesday, May 9, 2018)]
[Notices]
[Pages 21293-21294]
[FR Doc No: 2018-09857]

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DEPARTMENT OF ENERGY

Federal Energy Regulatory Commission

[Docket No. AD18-9-000]

Notice of Electric Quarterly Report Users Group Meeting

    On March 6, 2018 the Federal Energy Regulatory Commission
(Commission) issued a notice that Commission staff will hold an
Electric Quarterly Report (EQR) Users Group meeting on June 5, 2018.
The meeting will take place from 1:00 p.m. to 5:00 p.m. (EST), in the
Commission Meeting Room at 888 First Street NE, Washington, DC 20426.
All interested persons are invited to attend. For those unable to
attend in person, access to the meeting will be available via webcast.
    Commission staff is hereby supplementing the March 6, 2018 notice
with the agenda for discussion. During the meeting, Commission staff
and EQR users will discuss potential improvements to the EQR program
and the EQR filing process. Recent meetings have focused on issues
pertaining primarily to EQR filers. However, in the upcoming meeting,
staff will also include sessions for those accessing and using EQR
data. While discussion topics to be considered for the formal agenda
were due by April 16, 2018, feedback may be emailed to
[email protected].
    Commission staff will discuss and seek feedback on common EQR audit
findings, techniques for accessing EQR data, and examples of how EQR
data is used and interpreted. Please note that matters pending before
the Commission and subject to ex parte limitations cannot be discussed
at this meeting. An agenda of the meeting is attached.
    Due to the nature of the discussion, those interested in
participating are encouraged to attend in person. All interested
persons (whether attending in person or via webcast) are asked to
register online at http://www.ferc.gov/whats-new/registration/06-05-18-form.asp. There is no registration fee. Anyone with internet access can
listen to the meeting by navigating to www.ferc.gov's Calendar of
Events, locating the EQR Users Group Meeting on the Calendar, and
clicking on the link to the webcast. The webcast will allow persons to
listen to the technical conference and send questions during the
meeting to [email protected]. In the event you would also like to
participate in the meeting dialogue by phone please select the
telephone option when registering. If you have already registered for
the meeting, and would like to participate by phone, please re-register
and select the telephone option.
    Commission conferences are accessible under section 508 of the
Rehabilitation Act of 1973. For accessibility accommodations, please
send an email to [email protected] or call toll free 1-866-208-
3372 (voice) or<PHONE_NUMBER> (TTY), or send a FAX to<PHONE_NUMBER> with
the required accommodations.
    For more information about the EQR Users Group meeting, please
contact Jeff Sanders of the Commission's Office of Enforcement at (202)
502-6455, or send an email to [email protected].

    Dated: May 3, 2018.
Nathaniel J. Davis, Sr.,
Deputy Secretary.

Agenda

EQR Users Group Meeting Commission Meeting Room

Tuesday, June 5, 2018

1:00-1:15 p.m.
    Welcome, Introductions, and Logistics
    --Agenda Review
    --Ex Parte Limitations
    --Meeting Rules for Comments and Questions
1:15-1:45 p.m.
    Updates Since Last Meeting
    --New Frequently Asked Questions posted to EQR website
    --RTO/ISO Data Alignment Project Update
1:45-2:30 p.m.
    Common EQR Audit Findings
2:30-3:15 p.m.
    EQR Data Access
    --Methods for accessing EQR data
    --Feedback from EQR users on accessing EQR data
3:15-3:30 p.m.
    Break
3:30-4:15 p.m.

    EQR Data Uses
    --Applications of EQR data
    --Feedback from EQR users on EQR data uses
4:15-4:45 p.m.
    Data Interpretation
    --Interpreting EQR data using additional data sources
    --Feedback from EQR users on interpreting EQR data
4:45-5:00 p.m.
    Open Discussion
5:00 p.m.
    End of Meeting--Closing Remarks

[FR Doc. 2018-09857 Filed 5-8-18; 8:45 am]
 BILLING CODE 6717-01-P


[Federal Register: October 7, 2009 (Volume 74, Number 193)]
[Notices]
[Page 51633-51635]
[DOCID:fr07oc09-108]

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SECURITIES AND EXCHANGE COMMISSION

[Release No. 34-60753; File No. SR-CHX-2009-14]

Self-Regulatory Organizations; Chicago Stock Exchange, Inc.;
Notice of Filing and Immediate Effectiveness of Proposed Rule Change
Related to the Fees and Rebates in Various Trading Sessions

September 30, 2009.
    Pursuant to Section 19(b)(1) of the Securities Exchange Act of 1934
(``Act'') \1\ and Rule 19b-4 thereunder,\2\ notice is hereby given that
on September 22, 2009, the Chicago Stock Exchange, Inc. (``CHX'' or
``Exchange'') filed with the Securities and Exchange Commission (the
``Commission'') the proposed rule change as described in Items I, II
and III below, which Items have been prepared by the Exchange. CHX has
filed the proposal pursuant to Section 19(b)(3)(A) of the Act \3\ and
Rule 19b-4(f)(2) thereunder,\4\ which renders the proposal effective
upon filing with the Commission. The Commission is publishing this
notice to solicit

comments on the proposed rule change from interested persons.
---------------------------------------------------------------------------

    \1\ 15 U.S.C. 78s(b)(1).
    \2\ 17 CFR 240.19b-4.
    \3\ 15 U.S.C. 78s(b)(3)(A).
    \4\ 17 CFR 240.19b-4(f)(2).
---------------------------------------------------------------------------

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

    The CHX proposes to amend its Schedule of Participant Fees and
Assessments (the ``Fee Schedule''), effective September 28, 2009, to
provide for separate trading activity fees for its new Early and Late
Trading Sessions. The text of this proposed rule change is available on
the Exchange's Web site at http://www.chx.com/rules/proposed_rules.htm
and in the Commission's Public Reference Room, 100 F Street, NE.,
Washington, DC 20549.

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

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

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

1. Purpose
    In a separate filing, the Exchange has created a new Early Trading
Session beginning at 6 a.m. CT on days the Exchange is open for trading
and a Late Trading Session from 3 p.m. to 3:15 p.m. CT.\5\ We plan to
implement these two new sessions on September 28, 2009.
---------------------------------------------------------------------------

    \5\ SR-CHX-2009-13 (Sept. 1, 2009).
---------------------------------------------------------------------------

    In furtherance of this initiative, the Exchange proposes to amend
its Schedule of Participant Fees and Assessments. We propose to charge
a trading activity fee for single-sided orders of $0.003 per share for
liquidity taken in Tape A, B and C securities priced at or above $1 per
share in the new early and late trading sessions. A corresponding
rebate of $0.0022 per share for liquidity provided in such securities
would also be added to the Fee Schedule. Fees and rebates will be
assessed based upon the session in which the underlying transactions
were executed. We believe that these fees and charges are appropriate
to meet the Exchange's objective of attracting sufficient trading
activity in these sessions on a profitable basis. The increased
differential reflects, in part, our expectation of a lower amount of
market data revenue for trades executed in the Early and Late Trading
Sessions, and a corresponding reliance on trading activity fee revenue
to support the operational costs associated with these two sessions.
    The Exchange acknowledges that these charges differ from the fees
and rebates for such securities in the Regular Trading Session. Trading
activity fees and rebates, however, are often not uniform at a given
exchange depending on the circumstances. For example, Nasdaq and NYSE
Arca have different Tiers for take/provide fees for a member depending
on the average number of shares transacted and liquidity provided to
their exchanges. Trading activity fees and rebates frequently vary
depending on whether the security is reported as Tape A, B or C.
Provide rebates may vary depending on the nature of the order, e.g., if
the order was not displayed (Nasdaq) or was a Market-on-Close/Limit-on-
Close order (NYSE Arca). Finally, a number of exchanges, including the
CHX, have different take/provide rates for securities trading under $1.
Our charges for trading activity are and will continue to be disclosed
in the Fee Schedule posted on our public Web site and in a Legal Notice
to our Participants.
    The current fee and rebate structure for stocks trading under $1
would be extended to the Early and Late Trading Sessions. All other
current trading-related fees and charges would extend equally to the
Early and Late Trading Sessions. Fees and charges relating to cross
transactions executed in the Late Crossing Session would remain
unchanged.
2. Statutory Basis
    The Exchange believes that the proposed rule change is consistent
with Section 6(b) of the Act \6\ in general, and furthers the
objectives of Section 6(b)(4) of the Act \7\ in particular, in that it
provides for the equitable allocation of reasonable dues, fees and
other charges among its members. Among other things, the change to the
fee schedule would provide a reasonable amount of expected revenue to
the Exchange to offset the expenses of operating these new trading
sessions.
---------------------------------------------------------------------------

    \6\ 15 U.S.C. 78f.
    \7\ 15 U.S.C. 78f(b)(4).
---------------------------------------------------------------------------

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

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

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

    No written comments were either solicited or received.

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

    The foregoing rule change has become effective pursuant to Section
19(B)(3)(A)(ii) of the Act \8\ and subparagraph (f)(2) of Rule 19b-4
thereunder \9\ because it establishes or changes a due, fee, or other
charge applicable only to a member imposed by the self-regulatory
organization. Accordingly, the proposal is effective upon Commission
receipt of the filing. At any time within 60 days of the filing of such
rule change, the Commission may summarily abrogate such rule change if
it appears to the Commission that such action is necessary or
appropriate in the public interest, for the protection of investors, or
otherwise in furtherance of the purpose of the Act.
---------------------------------------------------------------------------

    \8\ 15 U.S.C. 78s(b)(3)(A)(ii).
    \9\ 17 CFR 240.19b-4(f)(2).
---------------------------------------------------------------------------

IV. Solicitation of Comments

    Interested persons are invited to submit written data, views and
arguments concerning the foregoing, including whether the proposal 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 No. SR-CHX-2009-14 on the subject line.

Paper Comments

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

All submissions should refer to File Number SR-CHX-2009-14. 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 changes 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 inspection and copying 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 will also be available for inspection and copying at the
principal office of the CHX. 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 No. SR-CHX-2009-14 and should be submitted on or before October
28, 2009.

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

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

Florence E. Harmon,
Deputy Secretary.
[FR Doc. E9-24082 Filed 10-6-09; 8:45 am]

BILLING CODE 8011-01-P