SUPPORTING STATEMENT

ENVIRONMENTAL PROTECTION AGENCY

NESHAP for Engine Test Cells/Stands (40 CFR Part 63, Subpart PPPPP)
(Renewal)

1.  Identification of the Information Collection

1(a)  Title of the Information Collection

NESHAP for Engine Test Cells/Stands (40 CFR Part 63, Subpart PPPPP)
(Renewal)

1(b)  Short Characterization/Abstract

The National Emission Standards for Hazardous Air Pollutants (NESHAP)
for Engine Test Cells/Stands were proposed on May 14, 2002 (67 FR
34547), and promulgated on May 27, 2003 (68 FR 28785).  This standard
applies to any new or reconstructed engine test cells/stands located at
major source facilities that are being used for testing internal
combustion engines with a rated power of 25 horsepower (hp) or more.  An
engine test cell/stand is any apparatus used for testing uninstalled
stationary or uninstalled mobile (motive) engines.  A plant site that is
a major source of hazardous air pollutant (HAP) emissions emits or has
the potential to emit any single HAP at a rate of 10 tons (9.07
megagrams) or more per year or any combination of HAP at a rate of 25
tons (22.68 megagrams) or more per year.  These new or reconstructed
sources must be in compliance with the requirements of the engine test
cells/stands NESHAP upon the startup of a new or reconstructed engine
test cell/stand.

Owners and operators must submit an initial notification report upon the
construction, or reconstruction of any engine test cells/stands used for
testing internal combustion engines.  For new or reconstructed engine
test cells/stands that startup before the effective date of this
subpart, the initial notification is due no later than 120 calendar days
after the effective date of the subpart.  For new or reconstructed
engine test cells/stands with startup on or after the effective date of
this subpart, the initial notification is due no later than 120 calendar
days after the source becomes subject to this subpart.

The respondents are required to submit a semiannual compliance report.
If there were no deviations from the emission limitation and the
continuous emission monitoring system (CEMS) is operating correctly, the
semiannual report must contain a statement by a responsible official
that no deviation occurred during the reporting period and that no CEMS
or continuous parameter monitoring system (CPMS) was out of control.  If
a deviation occurred from an emission limit, the report must contain
detailed information of the nature of the deviation.  Respondents of
effected sources must submit a notification of compliance status,
certifying that they have complied with the standard.  In addition, the
affected sources are required to use CEMS to monitor compliance with the
standard and to conduct a performance evaluation of the CEMS.

Any owner or operator subject to the provisions of this part will
maintain a file of these measurements, and retain the file for at least
five years following the date of such measurements, maintenance reports,
and records.  Each file will be on the site for at least two years after
the date of each occurrence, measurement, maintenance, report or record
and off-site for the remaining three years.  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.

Approximately 18 respondents are currently subject to the regulation,
and it is estimated that no additional respondents per year will become
subject to the regulation in the next three years.

There are approximately 18 engine test cells/stands facilities in the
United States, which are owned and operated by the engine test cells
industry.  None of the 18 facilities in the United States are owned by
state, local, tribal or the Federal government.  They are owned and
operated by privately owned for-profit businesses.  You can find the
burden to the “Affected Public” listed below in Table 1: Annual
Industry Burden and Cost - NESHAP for Engine Test Cells/Stands (40 CFR
Part 63, Subpart PPPPP) (Renewal).  The Federal government burden does
not include work performed by Federal employees.  The burden refers only
to work performed by contractors, which could be found listed below in
Table 2: Average Annual EPA Burden - NESHAP for Engine Test Cells/Stands
(40 CFR Part 63, Subpart PPPPP) (Renewal).

In the development of the ICR, we addressed the Office of Management and
Budget (OMB) “Terms of Clearance (TOC)” on the active ICR.  The TOC
are as follows:

When this ICR is renewed, EPA should review the respondent burden,
universe, labor rates, and capital costs and ensure these estimates have
been updated.

EPA has addressed each item of concern in the TOC.  The respondent
burden, universe, labor rates, and capital cost have been thoroughly
checked, and all estimates updated.

2.  Need for and Use of the Collection

2(a)  Need/Authority for the Collection

The EPA is charged under section 112 of the Clean Air Act, as amended,
to establish standards of performance for each category or subcategory
of major sources and area sources of hazardous air pollutants (HAP).
These standards are applicable to new or existing sources of HAP and
shall require the maximum degree of emission reduction.  In addition,
section 114(a) states that the Administrator may require any owner or
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, HAP emissions from engine test
cells/stands cause or contribute to air pollution that may reasonably be
anticipated to endanger public health or welfare.  Therefore, the NESHAP
was promulgated for this source category at 40 CFR part 63, subpart
PPPPP.

2(b)  Practical Utility/Users of the Data

The recordkeeping and reporting requirements in the standard ensure
compliance with the applicable regulations which were promulgated in
accordance with the Clean Air Act.  In addition, the collected
information is used for targeting inspections and as evidence in legal
proceedings.

Performance tests are required in order to determine an affected
facility’s initial capability to comply with the emission standard.
Continuous emission monitors are used to ensure compliance with the
standard at all times.  During the performance tests, a record of the
operating parameters under which compliance was achieved may be recorded
and used to determine compliance in place of a continuous emission
monitor.

The notifications required in the standard 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 ensure that the pollution control devices are properly installed and
operated, that leaks are being detected and repaired, and that the
standards are being met.  The performance test may also be observed.

	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 NESHAP continue to operate the
control equipment in compliance with the regulation.

3.  Non-duplication, Consultations, and Other Collection Criteria

The requested recordkeeping and reporting are required under 40 CFR part
63, subpart PPPPP.

3(a)  Non-duplication

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 their 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 (76 FR 26900) on May 9, 2011.  No
comments were received on the burden published in the Federal Register.

3(c)  Consultations

The Agency’s industry experts have been consulted, and the Agency’s
internal data sources and projections of industry growth over the next
three years have been considered.  The primary source of information as
reported by industry, in compliance with the recordkeeping and reporting
provisions in the standard, is the Online Tracking Information System
(OTIS) which is operated and maintained by the EPA Office of Compliance.
 OTIS is the EPA database for the collection, maintenance, and retrieval
of all compliance data.  The growth rate for the industry is based on
our consultations with the Agency’s internal industry experts.

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.  In developing this ICR, we contacted the Engine
Manufacturers Association at<PHONE_NUMBER>, and the National Marine
Manufacturers Association at<PHONE_NUMBER>.

It is our policy to respond after a thorough review of comments received
since the last ICR renewal as well as those submitted in response to the
First Federal Register Notice.

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

None of these reporting or recordkeeping requirements violate any of the
regulations established by OMB at 5 CFR part 1320, section 1320.5.

These standards require the respondents to maintain all records,
including reports and notifications for at least five years.  This is
consistent with the General Provisions as applied to the standards.  EPA
believes that the five-year records retention requirement is consistent
with the Part 70 permit program and the five-year statute of limitations
on which the permit program is based.  The retention of records for five
years allows EPA to establish the compliance history of a source, any
pattern of non-compliance, and to determine the appropriate level of
enforcement action.  EPA has found that the most flagrant violators have
violations extending beyond the five years.  Without the five-year
record retention, EPA would be prevented from pursuing the violators due
to the destruction or nonexistence of essential records.

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

None of the reporting or recordkeeping requirements contain sensitive
questions.

4.  The Respondents and the Information Requested

4(a)  Respondents/SIC Codes

The respondents to the recordkeeping and reporting requirements are
engine test cells/stands.  The United States Standard Industrial
Classification (SIC) codes which correspond to the North American
Industry Classification System (NAICS) codes are listed below for each
source category description.

40 CFR part 63, subpart PPPPP	SIC Codes	NAICS Codes

Turbine and Turbine Generator Set Units Manufacturing	3511	333611

Other Engine Equipment Manufacturing	3519	333618

All Other Motor Vehicle Parts Manufacturing	3519	336399

Hand and Edge Tool Manufacturing	3523	332212

Lawn and Garden Tractors and Home Lawn and Garden Equipment
Manufacturing	3524	333112

Hand and Edge Tool Manufacturing	3524	332212

Construction Machinery Manufacturing	3531	333120

Farm Machinery and Equipment Manufacturing	3559	333111

Other Commercial and Service Industry Machinery Manufacturing	3559
333319

Speed Changers, Industrial High-Speed Drives, and Gears Manufacturing
3566	333612

Motors and Generator Manufacturing	3621	335312

Automobile Manufacturing	3711	336111

Heavy Duty Truck Manufacturing	3711	336120

Light Truck and Utility Vehicle Manufacturing	3711	336112

Military Armored Vehicle, Tank, and Tank Component Manufacturing	3711
336992

Gasoline Engine and Engine Parts Manufacturing	3714	336312

Motor Vehicle Transmission and Power Parts Manufacturing	3714	336350

Aircraft Manufacturing	3721	336411

Research and Development in the Physical, Engineering, and Life Sciences
3721	541710

Aircraft Engine and Engine Parts Manufacturing	3724	336412

Research and Development in the Physical, Engineering, and Life Sciences
3724	541710

Guided Missile and Space Vehicle Manufacturing	3761	336414

Research and Development in the Physical, Engineering, and Life Sciences
3761	541710

Guided Missile and Space Vehicle Propulsion Unit and Propulsion Unit
Parts Manufacturing	3764	336415

Research and Development in the Physical, Engineering, and Life Sciences
3764	541710

Scheduled Passenger Air Transportation	4512	481111

Other Support Activities for Air Transportation	4581	488190

Research and Development in the Physical, Engineering, and Life Sciences
8731	541710

Testing Laboratories	8734	541380

Automobile Driving Schools	8299	611692

General Automotive Repair	7538	811111

Other Automotive Mechanical and Electrical Repair and Maintenance	7539
811118

Commercial and Industrial Machinery and Equipment (except Automotive and
Electronic) Repair and Maintenance	7699	811310

Home and Garden Equipment Repair and Maintenance	7699	811411

Space Research and Technology	9661	927110

National Security	9711	928110

4(b)  Information Requested

None of these reporting or recordkeeping requirements violate any of the
regulations established by OMB at 5 CFR part 1320, section 1320.5.

(i)  Data Items

In this ICR, all the data recorded or reported is required by National
Emission Standards for Hazardous Air Pollutants for Engine Test
Cells/Stands (40 CFR Part 63, Subpart PPPPP).

A source must make the following reports:

Notifications

Initial notification	63.9345 (b), 63.5(d), 63.9(b)

Notification of compliance status	63.9345(c), 63.9(h)

Notification of intent to conduct CEMS performance evaluation
63.9345(d), 63.8(e)(2)

Initial performance evaluation	63.9320(b), 63.9345(d), 63.8(e)(2)

Notification of alternative monitoring method	63.8(f)(4)

Waiver of recordkeeping or reporting requirements	63.10(f)

Additional notification	63.8(e), 63.8(f)(4), 63.8(f)(6), 63.9(b),
63.9(g)(1), 63.9(g)(2), 63.9(h), 63.9(j)

Semiannual compliance report	63.9340(b), 63.9350(a), 63.9350(b),
63.9350(c), 63.9350(d), 63.10(a), 63.10(e)

A source must keep the following records:

Recordkeeping

Maintain records of emission test results and other data needed to
determine compliance with emission limitation	63.9355(a)(5),
639355(a)(6), 63.9355(a)(7)

Maintain records of all reports and notifications	63.9355(a), 63.9350,
63.10(b)

Maintain records of applicability	63.10(b)(3)

Maintain records for sources with continuous monitoring systems
63.9355(a)(2), 63.9355(b), 63.9355(c), 63.10(b), 63.10(c)

Maintain records for initial notification and notification of compliance
status	63.9355(a)(1), 63.10(b)(2)(xiv)

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 not widely used.  At this time, it is
estimated that approximately 10 percent of the respondents are reporting
electronically.

(ii)  Respondent Activities

Respondent Activities

Read instructions.

Install, calibrate, maintain, and operate CEMS for opacity.

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 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

Observe initial performance tests and repeat performance tests if
necessary.

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

Audit facility records.

Input, analyze, and maintain data in the Online Tracking Information
System (OTIS).

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 operational.  Performance test reports are used
by the Agency to discern a source’s initial capability to comply with
the emission standard, and note the operating conditions under which
compliance was achieved.  Data and records maintained by the respondents
are tabulated and published for use in compliance and enforcement
programs.

Information contained in the reports is entered into OTIS which is
operated and maintained by the EPA Office of Compliance.  OTIS is the
EPA database for the collection, maintenance, and retrieval of
compliance data for approximately 125,000 industrial and
government-owned facilities.  EPA uses OTIS for tracking air pollution
compliance and enforcement by local and state regulatory agencies, EPA
regional offices, and EPA headquarters.  EPA edits, stores, retrieves,
and analyzes the data.

The records required by this regulation must be retained by the owner or
operator for five years.

5(c)  Small Entity Flexibility

	All of the current respondents are large entities (i.e., large
businesses).  However, the impact on small entities (i.e., small
businesses) was taken into consideration during the development of the
regulation.  Due to technical considerations involving the process
operations and the types of control equipment employed, the
recordkeeping and reporting requirements are the same for both small and
large entities.  The Agency considers these to be the minimum
requirements needed to ensure compliance and, therefore, cannot reduce
them further for small entities.  To the extent that larger businesses
can use economies of scale to reduce their burden, the overall burden
will be reduced.

5(d)  Collection Schedule

The specific frequency for each information collection activity within
this request is shown below in Table 1: Annual Respondent Burden -
NESHAP for Engine Test Cells/Stands (40 CFR Part 63, Subpart PPPPP)
(Renewal).

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.  Wherever 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 3,043
(Total Labor Hours from Table 1).  These hours are based on Agency
studies and background documents from the development of the regulation,
Agency knowledge and experience with the NESHAP program, the previously
approved ICR, and any comments received.

6(b)  Estimating Respondent Costs

(i)  Estimating Labor Costs

Managerial	$118.92 ($56.63 + 110%)

Technical	$97.78 ($46.56 + 110%)

Clerical	$48.76 ($23.22 + 110%)

These rates are from the United States Department of Labor, Bureau of
Labor Statistics, December 2010, "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 monitor 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)

Capital/Startup Cost for One Respondent 1	(C)

Number of New Respondents	(D)

Total Capital/Startup Cost,

(B X C)	(E)

Annual O&M Costs for One Respondent	(F)

Number of Respondents with O&M	(G)

Total O&M,

(E X F)

CPMS	$500	0	$0	$300	18	$5,400

	$0

	$5,400

 1 It is assumed that each new or reconstructed facility will purchase
five thermocouples at a cost of $100 per thermocouple for a total cost
of $500 per facility.

The total capital/startup costs for this ICR are $0.  This is the total
of column D in the above table.

The total operation and maintenance (O&M) costs for this ICR are $5,400.
 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 $5.000 (rounded).

6(c)  Estimating Agency Burden and Cost

The only costs to the Agency are those costs associated with analysis of
the reported information.  The EPA 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 $8,043.

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

		Managerial	$62.27 (GS-13, Step 5, $38.92 + 60%)

		Technical	$46.21 (GS-12, Step 1, $28.88 + 60%)

		Clerical	$25.01 (GS-6, Step 3, $15.63 + 60%)

These rates are from the Office of Personnel Management (OPM), 2011
General Schedule, which excludes locality rate 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: Average Annual EPA Burden - NESHAP for
Engine Test Cells/Stands (40 CFR Part 63, Subpart PPPPP) (Renewal).

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

	Based on our research for this ICR, on average over the next three
years, approximately 18 respondents will be subject to the standard.  It
is estimated that no new respondents per year will become subject to the
standard.  The overall average number of respondents, as shown in the
table below is 18 per year.

The number of respondents is calculated using the following table which
addresses the three years covered by this ICR.

Number of Respondents

Year	(A)

Number of New Respondents 1	(B)

Number of Existing Respondents	(C)

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

Number of Existing Respondents That Are Also New Respondents	(E)

Number of Respondents

(E=A+B+C-D)

1	0	18	N/A	0	18

2	0	18	N/A	0	18

3	0	18	N/A	0	18

Average	0	18	N/A	0	18

1 New respondents include sources with constructed, reconstructed, and
modified affected facilities.

To avoid double-counting respondents, column D is subtracted.  As shown
above, the average Number of Respondents over the three-year period of
this ICR is 18.

The total number of annual responses per year is calculated using the
following table:

Total Annual Responses

(A)

Information Collection Activity	(B)

Number of Respondents	(C)

Number of Responses	(D)

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

Total Annual Responses

E=(BxC)+D

Compliance status report	18	2	0	36

Performance evaluation report	2	1	0	2

Deviation report	1	2	0	2

Total Number of Annual Responses

	Total	40

The number of Total Annual Responses is 40.

The total annual labor costs are $288,361.  Details regarding these
estimates may be found below in Table 1: Annual Respondent Burden and
Cost - NESHAP for Engine Test Cells/Stands (40 CFR Part 63, Subpart
PPPPP) (Renewal).

6(e)  Bottom Line Burden Hours 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, respectively,
and summarized below.

(i)  Respondent Tally

The total annual labor hours are 3,043.  Details regarding these
estimates may be found below in Table 1: Annual Respondent Burden and
Cost - NESHAP for Engine Test Cells/Stands (40 CFR Part 63, Subpart
PPPPP) (Renewal).

Furthermore, the annual public reporting and recordkeeping burden for
this collection of information is estimated to average 76 hours per
response.

The total annual capital/startup and Operation and Maintenance (O&M)
costs to the regulated entity are $5,000.

(ii)  The Agency Tally

The average annual Agency burden and cost over next three years is
estimated to be 178 labor hours at a cost of $8,043.  See below Table 2:
Annual Agency Burden and Cost – NESHAP for Engine Test Cells/Stands
(40 CFR Part 63, Subpart PPPPP) (Renewal).

6(f)  Reasons for Change in Burden

There is no increase in the number of affected facilities or the number
of responses as compared to the previous ICR.  There is, however, an
increase in the estimated burden cost as currently identified in the OMB
Inventory of Approved Burdens.  The increase is not due to any program
changes.  The change in burden cost is due to the use of the most
updated labor rates.

6(g)  Burden Statement

The annual public reporting and recordkeeping burden for this collection
of information is estimated to average 76 hours per response.  Burden
means the total time, effort, or financial resources expended by persons
to generate, maintain, retain, disclose or provide information to or for
a Federal agency.  This includes the time needed to review instructions;
to 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; to adjust the existing ways to comply with any previously
applicable instructions and requirements; to train personnel to be able
to respond to a collection of information; to search data sources; to
complete and review the collection of information; and to 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=s 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-2011-0203.  An electronic version of the public docket is
available at   HYPERLINK "http://www.regulations.gov/"
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 content of the docket, and to access those
documents in the public docket that are available electronically.  When
in the system, select “search” than 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, DC.  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
(202) 566-1744, and the telephone number for the Enforcement and
Compliance Docket and Information Center Docket 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-2011-0203 and OMB Control Number
2060-0483 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
– NESHAP for Engine Test Cells/Stands (40 CFR Part 63, Subpart PPPPP)
(Renewal)

Burden item	(A)

Person hours per occurrence	(B)

No. of occurrences per respondent per year	(C)

Person hours per respondent per year

(C=AxB)	(D)

Respondents per year  a	(E)

Technical person- hours per year

(E=CxD)	(F)

Management person hours per year

(Ex0.05)	(G)

Clerical person hours per year

(Ex0.1)	(H)

Total Cost

Per year b

1.  Applications	N/A

	2.  Surveys and studies	N/A

	3.  Reporting requirements

    A.  Read instructions c 	4	1	4	0	0	0	0	$0

    B.  Notifications c

          Initial notifications	2	1	2	0	0	0	0	$0

          Notification of construction/reconstruction	2	1	2	0	0	0	0	$0

          Notification of anticipated startup	2	1	2	0	0	0	0	$0

          Notification of actual startup	2	1	2	0	0	0	0	$0

    C.  Create information	See 3B

	    D.  Gather existing information	See 3E

	    E.  Write report

          Compliance status report d	4	2	8	18	144	7.2	14.4	$15,638.68

          Performance evaluation report e	16	1	16	2	32	1.6	3.2	$3,475.26

          Deviation report f	16	2	32	1	32	1.6	3.2	$3,475.26

Subtotal  for Reporting  Requirements

239.2

4.  Recordkeeping requirements

    A.  Initial performance evaluation g, h, i	330	1	330	2	660	33	66
$71,677.32

    B.  Monitoring demonstration g, h, i	148	1	148	2	296	14.8	29.6
$33,146.20

    C.  Repeat performance evaluation g, h, j	330	1	330	0.4	132	6.6	13.2
$14,335.46

    D.  Maintain records of CEMS performance k	1.5	50	75	18	1,350	67.5
135	$146,612.70

Subtotal  for Recordkeeping Requirements

2,803.7

	2,646	132.3	264.6	$288,360.88

TOTAL LABOR BURDEN AND COST (rounded)

3,042.9

3,043

$288,361

Assumptions:

a  We have assumed that the average number of existing sources subject
to the rule will be 18.  There will be no additional new sources per
year that will become subject to the rule over the three-year period of
this ICR.

b  This ICR uses the following labor rates:  $118.92 per hour for
Executive, Administrative, and Managerial labor; $97.78 per hour for
Technical labor, and $48.76 per hour for Clerical labor.  These rates
are from the United States Department of Labor, Bureau of Labor
Statistics, December, 2010, 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.

c  We have assumed that there will be no new or reconstructed sources
over the next three years.

d  We have assumed that compliance status reports are required
semiannually.

e  We have assumed that 10 percent will have to write a performance
evaluation report once a year.

f  We have assumed that one of the eighteen sources will have to write a
deviation report.

g  We have assumed that all 18 sources are in compliance.

h  The technical persons-hours per occurrence were taken from the ESD
manual Table 4 “Burden of Performance Tests and Continuous Monitoring
System (CMS) Demonstrations” (Volume X, Section 2.2).

i  We have assumed that performance evaluations and monitoring
demonstrations will occur every five years.  According to calculations
the fifth year will fall on the first year of this renewal ICR, thus the
requirements will only pertain to six facilities of the active ICR.
Therefore, six facilities averaging over three years (6x3) = 2/yrs.

j  We have assumed that 20 percent of respondents will have to repeat
the performance evaluations due to failure.

k  We have assumed that owners and operators will have to maintain
monitoring records on a weekly basis.

Table 2:  Average Annual EPA Burden - NESHAP for Engine Test
Cells/Stands (40 CFR Part 63, Subpart PPPPP) (Renewal)

Activity	(A)

EPA person- hours per occurrence	(B)

No. of occurrences per plant per year	(C)

EPA person- hours per plant per year

(C=AxB)	(D)

Plants per year  a	(E)

Technical person- hours per year

(E=CxD)	(F)

Management person-hours per year

(Ex0.05)

	(G)

Clerical person-

hours per year

(Ex0.1)	(H)

Cost, $ b

1.  Attend CEMS performance evaluation	32	1	32	0	0	0	0	$0

2.  Repeat performance evaluation

 Retesting preparation	12	1	12	0	0	0	0	$0

 Attend retesting 	32	1	32	0	0	0	0	$0

3.  Deviation – enforcement activities c	16	1	16	3.6	57.6	2.88	5.76
$2,985.10

4.  Reporting requirements

 Review regulation 	2  	2	4	0	0	0	0	$0

 Review waivers	2	2	4	0	0	0	0	$0

 Review reports

             Review initial notification	2	1	2	0	0	0	0	$0

             Compliance status report d, e	2	2	4	14.4	57.6	2.88	5.76
$2,985.10

             Performance evaluation report f	2	1	2	18	36	1.8	3.6
$1,865.69

             Deviation report g	2	2	4	1	4	0.2	0.4	$207.29

Subtotals Labor Burden and cost

	155.2	7.76	15.52	$8,043.18

TOTAL ANNUAL BURDEN AND COST

 (rounded)

	178.48

178 (rounded)	$8,043

Assumptions:

a   We have assumed that the average number of existing sources subject
to the rule will be 18 and that no additional new sources will become
subject to the rule over the three-year period of this ICR.

b  This cost is based on the following labor rates which incorporates a
1.6 benefits multiplication factor to account for government overhead
expenses: $62.27 Managerial rate (GS-13, Step 5, $38.92 x 1.6), $46.21
Technical rate (GS-12, Step 1, $28.88 x 1.6), and $25.01 Clerical rate
(GS-6, Step 3, $15.63 x 1.6).  These rates are from the Office of
Personnel Management (OPM) 2011 General Schedule which excludes locality
rates of pay.

c  We have assumed that 20 percent of respondents will be out of
compliance.

d  We have assumed that 80 percent of respondents will be in compliance.

e  Compliance status reports review is required semiannually.

f   We have assumed that owners and operators are required to review
performance evaluation reports once a year.

g  We have assumed that one respondent will have their deviation report
reviewed on a semiannual basis.

 PAGE   1

 PAGE   13

  PAGE  16


[Federal Register Volume 88, Number 227 (Tuesday, November 28, 2023)]
[Notices]
[Pages 83125-83127]
[FR Doc No: 2023-26139]

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ENVIRONMENTAL PROTECTION AGENCY

[EPA-HQ-OW-2023-0287; FRL-11530-01-OW]

Proposed Information Collection Request; Comment Request; Textile
Mills Industry Data Collection

AGENCY: Environmental Protection Agency (EPA).

ACTION: Notice.

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

SUMMARY: The Environmental Protection Agency (EPA) is planning to
submit an information collection request (ICR), ``U.S. Environmental
Protection Agency Textile Mills Industry Data Collection'' (EPA ICR No.
2798.01, OMB Control No. 2040-NEW) to the Office of Management and
Budget (OMB) for review and approval in accordance with the Paperwork
Reduction Act (PRA). Before doing so, EPA is soliciting public comments
on specific aspects of the proposed information collection as described
below. This is a request for approval of a new collection. This notice
allows for 60 days for public comments.

DATES: Comments must be submitted on or before January 29, 2024.

ADDRESSES: Submit your comments, referencing Docket ID No. EPA-HQ-OW-
2023-0287, online using www.regulations.gov (our preferred method), by
email to [email protected], or by mail to: EPA Docket Center,
Environmental Protection Agency, Mail Code 28221T, 1200 Pennsylvania
Ave. NW, Washington, DC 20460.
    EPA's policy is that all comments received will be included in the
public docket without change including any personal information
provided, unless the comment includes profanity, threats, information
claimed to be Confidential Business Information (CBI), or other
information whose disclosure is restricted by statute.

FOR FURTHER INFORMATION CONTACT: Dr. Paul Shriner, Engineering and
Analysis Division, Office of Science and Technology, (4303T),
Environmental Protection Agency, 1200 Pennsylvania Ave. NW, Washington,
DC 20460; telephone number:<PHONE_NUMBER>; email address:
[email protected].

SUPPLEMENTARY INFORMATION: This is a request for approval of a new
collection. An 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.
    This notice allows 60 days for public comments. Supporting
documents, which explain in detail the information that the EPA will be
collecting, are available in the public docket for this ICR. The docket
can be viewed online at www.regulations.gov or in person at the EPA
Docket Center, WJC West, Room 3334, 1301 Constitution Ave. NW,
Washington, DC. The telephone number for the Docket Center is 202-566-
1744. For additional information about EPA's public docket, visit
http://www.epa.gov/dockets.
    Pursuant to section 3506(c)(2)(A) of the PRA (44 U.S.C. 3501 et
seq), EPA is soliciting comments and information to enable it to: (i)
evaluate whether the proposed collection of information is necessary
for the proper performance of the functions of the agency, including
whether the information will have practical utility; (ii) evaluate the
accuracy of the agency's estimate of the burden of the proposed
collection of information, including the validity of the methodology
and assumptions used; (iii) enhance the quality, utility, and clarity
of the information to be collected; and (iv) minimize the burden of the
collection of information on those who are to respond, including
through the use of appropriate automated electronic, mechanical, or
other technological collection techniques or other forms of information
technology, e.g., permitting electronic submission of responses. EPA
will consider the comments received and amend the ICR as appropriate.
The final ICR package will then be submitted to OMB for review and
approval. At that time, EPA will issue another Federal Register notice
to announce the submission of the ICR to OMB and the opportunity to
submit additional comments to OMB.
    Abstract: Under the Clean Water Act (CWA), the EPA develops
effluent limitations guidelines (ELGs) to limit pollutants discharged
from industrial point source categories. The EPA initially promulgated
the Textiles Mills ELGs in 1974 (39 FR 24736, July 5, 1974) and amended
the regulations in 1977 (42 FR 26979, May 26, 1977) and 1982 (47 FR
38810, September 2, 1982). Textiles mills receive and prepare fibers,
transforming these materials into yarn, thread or webbing. Other mills
convert yarns and webbing into fabric or related products and finish
these materials. Many textile mills produce a final consumer product
such as thread, yarn, fabric, hosiery, sheets, towels, and carpet. The
current regulation covers wastewater discharges from textile mills
which perform one or more of the following operations and discharge
process wastewater directly to surface waters or indirectly to surface
waters through publicly owned treatment works (POTWs): wool scouring,
wool finishing, yarn and unfinished fabric manufacturing, woven fabric
finishing, knit fabric finishing, carpet finishing, and nonwoven
textile products of wool, cotton, synthetics, or blends of such
fabrics.
    In the Preliminary Study of the Textiles Industry (July 1996), the
EPA presented an industry profile of establishments engaged in the
manufacture of textile products. Approximately 35 to 50 percent were
engaged in wet processing (dyeing, finishing, printing and coating),
and at least 90 percent of these facilities discharge their process
wastewater to POTWs. When compared with 1980 data, the industry in 1993
averaged 22 percent less water per pound of fiber processed as a result
of water conservation programs implemented by textile facilities.
    In the Preliminary Effluent Guidelines Program Plan 15 (86 FR
51155, September 2021), based on information and data the EPA collected
for the Preliminary Multi-Industry Per- and Polyfluoroalkyl Substances
(PFAS) Study, the EPA determined that PFAS have been and continue to be
used by textile and carpet manufacturers, a subset of facilities
regulated under the Textile Mills ELGs. The EPA's review of PFAS use
and discharge by the textile mills point source category is largely
based on publicly available information and literature. Based on a
small number of sample results, EPA determined that PFAS, including
legacy long-chain PFAS, are present in wastewater discharges from some
textile mills to POTWs. Most textile mills are not monitoring for PFAS,
nor are they required to do so. Therefore, the EPA expects that textile
mills may be discharging PFAS to POTWs or surface waters even when the
textile mill no longer uses PFAS in their process.
    As announced in the Effluent Guidelines Program Plan 15 (88 FR
6258, January 31, 2023), the EPA is continuing to evaluate the
available data on types and concentrations of PFAS in wastewater
discharged from textile mills. As indicated above there is limited
publicly available data on textile mills, including potential use and
discharge of PFAS, fluoropolymers, and fluorotelomers. The EPA has also
reviewed information on textile mills from Environmental Compliance
History Online (ECHO), the Integrated Compliance Information System
(ICIS), as well as data collected from several state environmental
agencies. However, very few of these data sources include PFAS
monitoring data. None of these data sources define a complete
population of textile mills in the United States, nor do they provide
detailed information on specific facility operations including any
recent phase out of PFAS usage.
    Therefore, a questionnaire for the textile mills industry is
necessary for the EPA to determine if the current regulations remain
appropriate and, if warranted, to develop and propose new regulations.
If new regulations are deemed to be warranted, the questionnaire is
essential for the EPA to complete the detailed technical analysis
necessary for the rulemaking. The EPA has identified and compiled
mailing addresses for approximately 2,200 textile manufacturing
facilities in the United States. A subsequent wastewater sampling
program will require a subset of approximately 20 textile manufacturing
facilities that completed the questionnaire to also collect wastewater
samples and submit them to an EPA-contracted laboratory. Wastewater
sampling data are critical for characterizing the wastewater generated
and discharged by textile manufacturing facilities, as well as
evaluating the effectiveness of pollution

control practices and technologies to reduce or eliminate PFAS in
discharges. The EPA will use these characterization data to estimate
current pollutant mass loads and achievable load reductions for
available technologies for the industry and to determine if the ELGs
warrant revision. Additional objectives of the questionnaire and
sampling will be to confirm the current population of textile mills,
confirm which mills still use PFAS in their processes, as well as
gather facility-specific information and data relevant to generation
and discharge of PFAS-containing wastewater by the industry.
    Confidential Business Information (CBI) may be collected. In
accordance with 40 CFR part 2, subpart B, section 2.203, the survey
informs respondents of their right to claim information as
confidential. Each survey provides instructions for claiming
confidentiality and informs respondents of the terms and rules
governing the protection of CBI under the Clean Water Act and 40 CFR
2.203(b). Survey respondents are requested to mark any claimed
confidential responses as CBI. EPA and its contractors will follow
EAD's existing procedures to protect data labeled as CBI.
    Form Numbers: None.
    Respondents/affected entities: Up to 2,200 textile mills in the
U.S. will receive the questionnaire and no more than 20 facilities will
be asked to conduct specific wastewater sampling.
    Respondent's obligation to respond: Mandatory (Clean Water Act
Section 308) (citing authority).
    Estimated number of respondents: Up to 2,200 (total).
    Frequency of response: One-time data collection.
    Total estimated respondent burden: 30,008 hours. Burden is defined
at 5 CFR 1320.03(b).
    Total estimated respondent cost: $1,339,982 one-time cost.
    Changes in Estimates: This is a new data collection request and is
a one-time temporary increase to the agency's burden.

    Deborah Nagle,
Director, Office of Science and Technology, Office of Water.
[FR Doc. 2023-26139 Filed 11-27-23; 8:45 am]
BILLING CODE 6560-50-P


[Federal Register: February 4, 2010 (Volume 75, Number 23)]
[Notices]
[Page 5824-5826]
[DOCID:fr04fe10-83]

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SECURITIES AND EXCHANGE COMMISSION

[Release No. 34-61433; File No. SR-ISE-2010-04]

Self-Regulatory Organizations; International Securities Exchange,
LLC; Notice of Filing and Immediate Effectiveness of Proposed Rule
Change To Correct Inconsistencies in Certain Execution Rules

January 27, 2010.
    Pursuant to Section 19(b)(1) of the Securities Exchange Act of 1934
(the ``Act''),\1\ and Rule 19b-4 thereunder,\2\ notice is hereby given
that on January 13, 2010, the International Securities Exchange, LLC
(the ``Exchange'' or the ``ISE'') filed with the Securities and
Exchange Commission the proposed rule change as described in Items I,
II, and III below, which items have been prepared by the self-
regulatory organization. The Commission is publishing this notice to
solicit comments on the proposed rule change from interested persons.
---------------------------------------------------------------------------

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

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

    The Exchange proposes to correct inconsistencies in certain of its
execution rules. The text of the proposed rule change is available on
the Exchange's Web site (http://www.ise.com), at the principal office
of the Exchange, and at the Commission's Public Reference Room.

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

    In its filing with the Commission, the self-regulatory organization
included statements concerning the purpose of, and basis for, the
proposed rule change and discussed any comments it received on the
proposed rule change. The text of these statements may be examined at
the places specified in Item IV below. The self-regulatory organization
has prepared summaries, set forth in

sections A, B and C below, of the most significant aspects of such
statements.

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

1. Purpose
    In January 2009,\3\ the Exchange received Commission approval of a
rule change to give certain non-broker-dealer orders (identified as
Professional Orders) the priority given broker-dealer orders and market
maker quotes rather than the priority given all public customer orders.
Those public customers who continue to receive priority in the
execution algorithm are called Priority Customers under the rule
change. The rule change uniformly changed the execution priority in
each of the Exchange's execution rules as they existed in January 2009.
After reviewing its execution rules, the Exchange has identified three
inconsistencies with the Priority Customer priority execution rules.
Accordingly, the Exchange proposes to amend these execution rules to be
consistent with what is now the standard execution algorithm:
---------------------------------------------------------------------------

    \3\ Securities Exchange Act Release No. 59287 (January 23,
2009), 74 FR 5694 (January 30, 2009).
---------------------------------------------------------------------------

    (i) Rule 715(g) regarding Reserve Orders. The proposed change
clarifies that the execution of the displayed portion of a Reserve
Order will follow the standard priority rules that now provide priority
only to Priority Customers.\4\
---------------------------------------------------------------------------

    \4\ Reserve orders are limit orders that contain both a
displayed portion and a non-displayed portion. The entire size of a
displayed price (including Priority Customer Orders, Professional
Orders, and market maker quotes) is executed in full before any
portion of the non-displayed portion of a reserve order. See ISE
Rule 713(c) and ISE Rule 715(g)5.
---------------------------------------------------------------------------

    (ii) Rule 715(i) and Rule 721(a) regarding Customer Cross Orders. A
Customer Cross Order is currently defined as a Public Customer order to
buy and a Public Customer order to sell, and such orders are not
permitted to trade at the same price as Public Customers on the book.
Since only Priority Customer Orders receive priority, the proposed
change narrows the definition of a Customer Cross Order to Priority
Customers only and specifies that such orders cannot be executed at the
same price as Priority Customer Orders.\5\
---------------------------------------------------------------------------

    \5\ Under ISE Rule 717(d) and (e), members are required to
expose trading interest to the market before executing agency orders
as principal or before executing agency orders against orders that
were solicited from other broker-dealers (i.e., proprietary and
solicited crossing transactions). However, the ISE options rules do
not contain any limitations or exposure requirements regarding the
execution of customer orders against other customer orders. Customer
Cross Orders was adopted to provide a way to enter opposing customer
orders using a single order type that protected customer orders on
the book. See Securities Exchange Act Release No. 60253 (July 7,
2009), 74 FR 34063 (July 14, 2009). While only Priority Customers
will be permitted to be executed using the Customer Cross Order
under the proposed rule change, Rule 717(d) continues to allow the
execution of all Public Customer Orders against other Public
Customer Orders without an exposure period. Communication between
Samir Patel, Assistant General Counsel, ISE and Ira Brandriss,
Special Counsel, Division of Trading and Markets, Commission, on
January 26, 2010. Members may continue to enter two Public Customer
orders on the exchange with the intent to cross them without the use
of the Customer Cross Order type.
---------------------------------------------------------------------------

    (iii) Rule 803, Supplementary Material .02 regarding flash orders.
Execution of a flash order when the ISE BBO changes during the exposure
period to a price that matches against the order being flashed is
according to the standard priority rules that now provide priority only
to Priority Customers.
    The Exchange also proposes to delete a provision from Rule 721
regarding Customer Cross Orders that was related to a block exemption
from the old linkage rules that does not now exist under the
distributive linkage plan.
2. Statutory Basis
    The basis under the Securities Exchange Act of 1934 (``Exchange
Act'') for this proposed rule change is the requirement under Section
6(b)(5) that an exchange have rules that are designed to promote just
and equitable principles of trade, and to remove impediments to and
perfect the mechanism for a free and open market and a national market
system, and in general, to protect investors and the public interest.
In particular, the proposal corrects inconsistencies in the Exchange's
rules.

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

    The proposed rule change does not 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 on the Proposed
Rule Change Received From Members, Participants or Others

    The Exchange has not solicited, and does not intend to solicit,
comments on this proposed rule change. The Exchange has not received
any unsolicited written comments from members or other interested
parties.

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

    Because the foregoing proposed rule change does not (1)
significantly affect the protection of investors or the public
interest; (2) impose any significant burden on competition; and (3)
become operative for thirty days from the date on which it was filed,
or such shorter time as the Commission may designate if consistent with
the protection of investors and the public interest, it has become
effective pursuant to Section 19(b)(3)(A) of the Act \6\ and Rule 19b-
4(f)(6) \7\ thereunder.\8\
---------------------------------------------------------------------------

    \6\ 15 U.S.C. 78s(b)(3)(A).
    \7\ 17 CFR 240.19b-4(f)(6).
    \8\ Pursuant to Rule 19b-4(f)(6)(iii), the Exchange gave the
Commission written notice of its intent to file the proposed rule
change, along with a brief description and text of the proposed rule
change, at least five business days prior to the date on which the
Exchange filed the proposed rule change. See 17 CFR 240.19b-
4(f)(6)(iii).
---------------------------------------------------------------------------

    At any time within 60 days of the filing of such proposed 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 purposes of the Act.

IV. Solicitation of Comments

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

Electronic Comments

     Use the Commission's Internet comment form (http://
www.sec.gov/rules/sro.shtml); or
     Send an e-mail to<EMAIL_ADDRESS>Please include
File Number SR-ISE-2010-04 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-ISE-2010-04. 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,\9\ 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 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 the filing also will be available for inspection and copying at the
principal office of the ISE. All comments received will be posted
without change; the Commission does not edit personal identifying
information from submissions. You should submit only information that
you wish to make available publicly. All submissions should refer to
File Number SR-ISE-2010-04 and should be submitted on or before
February 25, 2010.
---------------------------------------------------------------------------

    \9\ The text of the proposed rule change is available on ISE's
Web site at http://www.ise.com, on the Commission's Web site at
http://www.sec.gov, at ISE, and at the Commission's Public Reference
Room.

    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. 2010-2333 Filed 2-3-10; 8:45 am]
BILLING CODE 8011-01-P


[Federal Register Volume 76, Number 156 (Friday, August 12, 2011)]
[Notices]
[Pages 50324-50326]
[FR Doc No: 2011-20582]

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

DEPARTMENT OF TRANSPORTATION

Federal Railroad Administration

Notice of Availability of a Draft Environmental Impact Report/
Environmental Impact Statement for the California High-Speed Rail
Project Merced to Fresno Section

AGENCY: Federal Railroad Administration (FRA), United States Department
of Transportation (DOT).

ACTION: Notice.

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

SUMMARY: FRA is issuing this notice to advise the public that a Draft
Environmental Impact Report (EIR)/Environmental Impact Statement (EIS)
has been prepared for the California High-Speed Train (HST) Project
Merced to Fresno Section (Project). FRA is the lead Federal agency and
the California High-Speed Rail Authority (Authority) is the lead state
agency for the environmental review process.
    The Authority proposes to construct and operate a reliable high-
speed electric-powered passenger train system along an approximately
65-mile corridor, from Merced, CA, to Fresno, CA that links those
cities by delivering predictable and consistent travel times. The
Project includes high-speed track alignments, stations in downtown
Merced and Fresno. A heavy maintenance facility for assembly, testing,
and commissioning of trains,

train inspection and service, and train overhaul may be constructed in
the Merced to Fresno Section.
    The Draft EIR/EIS presents the Project's purpose and need,
identifies all reasonable alternatives including track alignments,
stations, and heavy maintenance facilities as well as the no action
alternative, describes the affected environment, analyzes the potential
environmental impacts of all the reasonable alternatives and the no
action alternative, and identifies appropriate mitigation measures to
minimize the potential environmental impacts.

DATES: Written comments on the Draft EIR/EIS for the Project should be
provided to the Authority on or before September 28, 2011. Public
hearings are scheduled on September 14, 2011, September 15, 2011, and
September 20, 2011 in Merced, CA, Madera, CA, and Fresno, CA
respectively at the times and dates listed in the Addresses Section
below.

ADDRESSES: Written comments on the Draft EIR/EIS should be sent to the
California High-Speed Rail Authority, Merced to Fresno EIR/EIS Comment,
770 L Street, Suite 800, Sacramento, CA 95814, through the Authority's
Web site at http://www.cahighspeedrail.ca.gov, or via e-mail with the
subject line ``Draft EIR/EIS'' to<EMAIL_ADDRESS>Comments
may also be provided orally or in writing at the public hearings
scheduled at the following locations:
     Merced, CA, Wednesday, September 14, 2011, 3 to 8 p.m.,
Merced Community Senior Center, 755 West 15th Street, Merced, CA 95340;
     Madera, CA, Thursday, September 15, 2011, 3 to 8 p.m.,
Madera City Council Chambers, 205 W. 4th Street, Madera, CA 93637; and
     Fresno, CA, Tuesday, September 20, 2011, 3 to 8 p.m.,
Fresno Convention Center, 848 M Street, Fresno, CA.

FOR FURTHER INFORMATION CONTACT: Mr. David Valenstein, Chief,
Environment and Systems Planning Division, Office of Railroad Policy
and Development, Federal Railroad Administration, U.S. Department of
Transportation, 1200 New Jersey Avenue, SE., MS-20, Washington, DC
20590 (telephone:<PHONE_NUMBER>), or Mr. Dan Leavitt, Deputy Director
for Environmental Review and Planning, California High-Speed Rail
Authority, 770 L Street, Ste. 800, Sacramento, CA 95814 (telephone:
916-324-1541).

SUPPLEMENTARY INFORMATION: Once completed, the California HST system
will provide intercity, high-speed passenger rail service on more than
800 miles of tracks throughout California, connecting the major
population centers of Sacramento, the San Francisco Bay Area, the
Central Valley, Los Angeles, the Inland Empire, Orange County, and San
Diego. It will use state-of-the-art, electrically powered, high-speed,
steel-wheel-on-steel-rail technology, including contemporary safety,
signaling, and automated train-control systems, with trains capable of
operating up to 220 miles per hour (mph) over a fully grade-separated,
dedicated double track alignment.
    The FRA and Authority certified a Statewide Program EIR/EIS (Tier
1) for the California HST system in November 2005 as the first phase of
a tiered environmental review process for the California HST system. In
2008, the FRA and Authority certified another program EIR/EIS for the
Bay Area to Central Valley portion of the HST system. The Merced to
Fresno Section Draft EIR/EIS (Tier 2) analyzes the environmental
impacts and benefits of implementing the high-speed train in the more
geographically limited area between Merced and Fresno, and is based on
more detailed project planning and engineering. This Draft EIR/EIS
analysis builds on the earlier decisions and program EIR/EISs, and
provides more site-specific and detailed analysis.
    The Authority plans to complete the California HST System in two
phases. Phase 1 will connect San Francisco to Los Angeles/Anaheim via
the Pacheco Pass and the Central Valley with a mandated express travel
time of 2 hours and 40 minutes or less. Phase 2 will connect the
Central Valley to the state's capital, Sacramento, and will extend the
system from Los Angeles to San Diego. This Project is for one section
in Phase 1 and is receiving funding from FRA for design and
environmental review as well as for the construction of an initial
Section in the Central Valley.
    The American Recovery and Reinvestment Act of 2009 (Recovery Act),
enacted February 17, 2009, contained $8 billion to fund high-speed and
intercity passenger rail (HSIPR) projects. In response to the Recovery
Act funding, FRA developed and began implementation of the HSIPR
Program to fund project to improve existing intercity passenger rail
service and to develop new high speed intercity passenger rail
corridors. FRA's HSIPR Program also received an additional $2.1 billion
from the Transportation, Housing, and Urban Development and Related
Agencies Appropriations Act of 2010. The California High-Speed Rail
Authority applied for and was selected to receive over $3.5 billion in
HSIPR funds from FRA to complete preliminary engineering and NEPA
reviews, and associated documentation for all eight segments comprising
the California HST System and to construct an initial Central Valley
Section from Madera County to Bakersfield (Kern County) California.
Completion of the environmental review process marked by issuance of a
Record of Decision (ROD) by FRA is a prerequisite for any construction
related Federal funding or approvals from FRA.
    The approximately 65-mile-long Merced to Fresno Section is an
essential part of the statewide HST System. The Merced to Fresno
Section is the location of the connection between the Bay Area and
Sacramento branches of the HST System; it will provide Merced and
Fresno access to a new transportation mode and will contribute to
increased mobility throughout California. This Section will connect the
central San Joaquin Valley region to the remainder of the HST System
via Merced County, Madera County, and the northern part of the city of
Fresno.
    This Draft EIR/EIS has been prepared by the FRA and the Authority
consistent with the provisions of Section 102(2)(c) of the National
Environmental Policy Act (NEPA) of 1969 (42 U.S.C. 4321 et seq.), the
Counsel of Environmental Quality (CEQ) regulations implementing NEPA
(40 CFR parts 1500 et seq.), FRA's Procedures for Considering
Environmental Impacts (64 FR 28545 (May 26, 1999)), and in conformity
with the California Environmental Quality Act (CEQA) (California Public
Resources Code Section 21000 et. seq.), and the CEQA Guidelines
(California Code of Regulations, Title 14, Section 15000 et. seq.).
    Copies of the Draft EIR/EIS are available online at FRA's Web site:
http://www.fra.dot.gov and the Authority's Web site: http://www.cahighspeedrail.ca.gov; they are also available for viewing at the
following locations near the planned rail system:
     Fresno County Public Library, Central Branch, 2420
Mariposa Street, Fresno, CA 93721;
     Madera County Library, 121 North G Street, Madera, CA
93637;
     Chowchilla Branch Library (Madera County Library), 300
Kings Avenue, Chowchilla, CA 93610;
     Merced Community Senior Center, 755 West 15th Street,
Merced, CA 95340;
     Merced County Library, 2100 O Street, Merced, CA 95340;
     Galilee Missionary Baptist Church, 22941 Fairmead
Boulevard, Chowchilla, CA 93610;

     Le Grand Branch Libarary, 12949 Le Grand Road, Le Grand,
CA 95333;
     Lao Family Community, 855 W. 15th Street, Merced, CA
95333;
     Madera Ranchos Branch Library, 37167 Avenue 12, Suite 4C,
Madera, CA 95636;
     Merced County Los Banos Branch Library, 1312 South Seventh
Street, Los Banos, CA 93635; and
     Atwater Branch Library, 1600 Third Street, Atwater, CA
95301.

    Issued in Washington, DC, on August 9, 2011.
Corey W. Hill,
Director, Rail Project Development and Delivery.
[FR Doc. 2011-20582 Filed 8-11-11; 8:45 am]
BILLING CODE 4910-06-P


[Federal Register Volume 85, Number 46 (Monday, March 9, 2020)]
[Notices]
[Page 13661]
[FR Doc No: 2020-04691]

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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2020-N-0601]

Mylan Institutional LLC et al.; Withdrawal of Approval of 16
Abbreviated New Drug Applications

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice.

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

SUMMARY: The Food and Drug Administration (FDA or Agency) is
withdrawing approval of 16 abbreviated new drug applications (ANDAs)
from multiple applicants. The applicants notified the Agency in writing
that the drug products were no longer marketed and requested that the
approval of the applications be withdrawn.

DATES: Approval is withdrawn as of April 8, 2020.

FOR FURTHER INFORMATION CONTACT: Martha Nguyen, Center for Drug
Evaluation and Research, Food and Drug Administration, 10903 New
Hampshire Ave., Bldg. 75, Rm. 1676, Silver Spring, MD 20993-0002, 240-
402-6980<EMAIL_ADDRESS>
SUPPLEMENTARY INFORMATION: The applicants listed in the table have
informed FDA that these drug products are no longer marketed and have
requested that FDA withdraw approval of the applications under the
process described in Sec.  314.150(c) (21 CFR 314.150(c)). The
applicants have also, by their requests, waived their opportunity for a
hearing. Withdrawal of approval of an application or abbreviated
application under Sec.  314.150(c) is without prejudice to refiling.

------------------------------------------------------------------------
       Application No.                Drug                Applicant
------------------------------------------------------------------------
ANDA 040471.................  Promethazine          Mylan Institutional
                               Hydrochloride (HCl)   LLC, 4901 Hiawatha
                               Injection, 25         Dr., Rockford, IL
                               milligrams (mg)/      61103.
                               milliliters (mL).
ANDA 060286.................  Penicillin G          Pfizer, Inc., 235
                               Procaine Injection,   East 42nd St., New
                               300,000 units/mL      York, NY 10017.
                               and 600,000 units/
                               mL.
ANDA 065247.................  Cefazolin Sodium for  Hospira, Inc., 275
                               Injection,            North Field Dr.,
                               Equivalent to (EQ)    Bldg. H1, Lake
                               10 grams base/vial.   Forest, IL 60045.
ANDA 065488.................  Azithromycin Oral     Lupin
                               Suspension, EQ 100    Pharmaceuticals,
                               mg base/5 mL; EQ      Inc., 111 South
                               200 mg base/5 mL.     Calvert St.,
                                                     Harborplace Tower,
                                                     21st Floor,
                                                     Baltimore, MD
                                                     21202.
ANDA 076185.................  Dimethyl Sulfoxide    Mylan Institutional
                               Intravesical          LLC.
                               Solution, 50%.
ANDA 076428.................  Milrinone Lactate     Do.
                               Injection, EQ 1 mg
                               base/mL.
ANDA 076488.................  Mesna Injection, 100  Do.
                               mg/mL.
ANDA 078410.................  Topiramate Tablets,   Lupin
                               25 mg, 50 mg, 100     Pharmaceuticals,
                               mg, and 200 mg.       Inc.
ANDA 078957.................  Stavudine Capsules,   Hetero USA, Inc.,
                               15 mg, 20 mg, 30      1035 Centennial
                               mg, and 40 mg.        Ave., Piscataway,
                                                     NJ 08854.
ANDA 090441.................  Imipramine HCl        Lupin
                               Tablets, 10 mg, 25    Pharmaceuticals,
                               mg, and 50 mg.        Inc.
ANDA 200563.................  Ciprofloxacin Oral    Do.
                               Suspension, 250 mg/
                               5 mL and 500 mg/5
                               mL.
ANDA 205657.................  Chlorpheniramine      Mayne Pharma Inc.,
                               Maleate,              1240 Sugg Pkwy.,
                               Hydrocodone           Greenville, NC
                               Bitartrate, and       27834.
                               Pseudoephedrine HCl
                               Solution, 4 mg/5
                               mL; 5 mg/5 mL; and
                               60 mg/5 mL.
ANDA 205658.................  Hydrocodone           Do.
                               Bitartrate and
                               Pseudoephedrine HCl
                               Oral Solution, 5 mg/
                               5 mL; and 60 mg/5
                               mL.
ANDA 200624.................  Metformin HCl, and    Lupin
                               Repaglinide           Pharmaceuticals,
                               Tablets, 500 mg/1     Inc.
                               mg; 500 mg/2 mg.
ANDA 202384.................  Omeprazole Delayed-   Do.
                               Release Capsules,
                               40 mg.
ANDA 202532.................  Clarithromycin        Do.
                               Extended-Release
                               Tablets, 500 mg.
------------------------------------------------------------------------

    Therefore, approval of the applications listed in the table, and
all amendments and supplements thereto, is hereby withdrawn as of April
8, 2020. Approval of each entire application is withdrawn, including
any strengths and dosage forms inadvertently missing from the table.
Introduction or delivery for introduction into interstate commerce of
products without approved new drug applications violates section 301(a)
and (d) of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 331(a)
and (d)). Drug products that are listed in the table that are in
inventory on April 8, 2020 may continue to be dispensed until the
inventories have been depleted or the drug products have reached their
expiration dates or otherwise become violative, whichever occurs first.

    Dated: March 2, 2020.
Lowell J. Schiller,
Principal Associate Commissioner for Policy.
[FR Doc. 2020-04691 Filed 3-6-20; 8:45 am]
 BILLING CODE 4164-01-P