1 SF 83 SUPPORTING STATEMENT ENVIRONMENTAL PROTECTION AGENCY National Emission Standards for Hazardous Air Pollutant Emissions for Polyether Polyol Production 1. Identification of the Information Collection 1( a) Title of the Information Collection National Emissions Standards for Hazardous Air Pollutants ( NESHAP) for Polyether Polyols Production. This is a continuing information collection request ( ICR), and the U. S.

Environmental Protection Agency ( EPA) tracking number for this ICR is 1811.03 and OMB is 2060 0415.

1( b) Short Characterization/ Abstract The National Emissions Standards for Hazardous Air Pollutants for Polyether Polyols Production, ( 40 CFR Part 63) was proposed on June l, 1999. and published January 30, 2002.

These regulations apply to new and existing facilities that engage in the manufacture of polyether polyols ( which also include polyether mono ols) and emit hazardous air pollutants ( HAP).

Owners or operators of polyether polyols production facilities to which this regulation is applicable must choose one of the compliance options described in the rule or install and monitor a specific control system that reduces HAP emissions to the compliance level. The respondents are also subject to sections of Subpart A relating to NESHAP.

In general, all NESHAP 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 start up, 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 NESHAP.

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 five years following the date of such measurements,

maintenance reports, and records. All reports are sent to the delegated State or Local authority. 2 In the event that there is no such delegated authority, the reports are sent directly to the EPA Regional Office. There are approximately 79 facilities that are subject to the regulation and according to the industry trade association, three new facilities are expected to be constructed in the next 3 years, with existing plants not adding additional polyether polyol processing units which may be considered a major modification or reconstruction. The predominant HAP's used in polyether polyols production include ethylene oxide, propylene oxide, toluene, and hexane.

The information will be used by Agency enforcement personnel to ( 1) identify new, modified,

reconstructed, and existing sources subject to the standards; and ( 2) ensure that MACT is being properly applied and that compliance is being maintained and documented.

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. These standards are applicable to new or existing sources of hazardous air pollutants 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 judgement, the pollutants emitted from polyester polyols production facilities cause or contribute significantly to air pollution that may reasonably be anticipated to endanger public health. Therefore, this source category was listed for regulation under section 112, 40 CFR Part 63,

Subpart PPP.

TERMS OF CLEARANCE: This information collection request number 1811.03 OMB 3 number 2060 0415 is a renewal and the annual report and recordkeeping burden hours and cost burden hours are reflected on the OMB form 83 1 blocks 13 and 14 respectively. These costs reflect projected facility growth of one new facility per year over the next three years.

2( b) Practical Utility/ Users of the Data The control of emissions of HAPs from polyester, polyol production facilities requires not only the installation of properly designed equipment, but also the operation and maintenance of that equipment.

Emissions of HAPs from polyester, polyol production facilities are the result of operation of the affected facilities. The subject standards are achieved by the reduce of HAPs emissions using control technology and leak detection and repair procedures. 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/ or leaks are being detected and repaired 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. The semiannual reports are used for problem identification, as a check on source operation and maintenance, and for compliance determinations. 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 and achieve compliance with the regulation. Adequate monitoring, recordkeeping, and reporting is necessary to ensure compliance with the applicable regulations, as required by the Clean Air Act. The information collected from recordkeeping and reporting requirements is also used for targeting inspections, and is of sufficient quality to be used as evidence in court.

3. Nonduplication, Consultations, and Other Collection Criteria The recordkeeping and reporting requested is required under 40 CFR Part 63 Subpart PPP.

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 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 4 An announcement of a public comment period for the renewal of this ICR was published in the Federal Register on January 30, 2002. No comments were received ..

3( c) Consultations We contacted the Society of the Plastic Industry ( SPI) and the American Plastic Industry ( API) regarding the number of facilities that are or are projected to be subject to this rule and the responses were inclusive. For the purpose of this Information Collection Request, number 1811.03,

entitled: NESHAP for Polyester Polyols Production, 40 CFR Part 63, Subpart PPP, we anticipate facility growth rate at one facility over the next three years. No comments were received from the Federal Register on January 30, 2002.

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 likelihood of detecting poor operation and maintenance of control equipment and noncompliance would decrease.

3( e) General Guidelines None of these reporting or recordkeeping requirements violate any of the regulations established by OMB at 5 CFR 1320.6.

3( f) Confidentiality The required information consists of emissions data and other information that have been determined not to be private. However, 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 l, Part 2, subpart B  Confidentiality of Business Information ( see 40 CFR 2; 41 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 5 4( a) Respondents/ SIC Codes The respondents to the recordkeeping and reporting requirements are polyester, polyols production facilities.. The SIC code for the respondents affected by the standards is SIC ( U. S.

Standard Industrial Classification) 2834 and 2829 which corresponds to the NAICS ( The North American Industry Classification System) 325613 and 325199 respectively for polyester, polyols production facilities.

Regulation SIC Codes NAICS Codes National Emission Standards for Hazardous Air Pollutant Emissions for Polyester Polyol Production ( 40 CER 63, Subpart PPP 2834,2869 325613,325199 ( b) Information Requested These standards require affected facilities 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 the Part 70 permit program and the five year statute of limitations on which the permit program is based. Also,

the retention of records for five years would allow EPA to establish the compliance history of a source and any pattern of compliance for purposes of determining the appropriate level of enforcement action. Historically, EPA has found that the most flagrant violators frequently have violations extending beyond the five years. EPA would be prevented from pursuing the worst violators due to the destruction or nonexistence of records if records were retained for less than five years.

( i) Data Items All data in this ICR that is recorded and/ or reported is required by National Emission Standards for Hazardous Air Pollutant Emissions for Polyester Polyols Production, 40 CFR Part 63,

Subpart PPP.

A source must make the following reports: 6 Reports for National Emission Standards for Hazardous Air Pollutant Emissions for Polyether Polyols Production Construction/ reconstruction 60.7( a)( 1), 63.5 Construction or modification application 61.07 Initial notifications 63.9( b)

Anticipated start up 60.7( a)( 2), 61.09( a)( 1)

Actual start up 60.7( x)( 3), 61.09( x)( 2 )

Initial performance test results 60.8 ( a), 61.13( f), 63.10( d)( 2)

Initial performance test 60.8( d), 61.13( c), 63.7( b), 63.9( e)

Rescheduled initial performance test 63.7( b)( 2)

Demonstration of continuous monitoring system 60.7( x)( 5), 63.9( g)

Compliance status 63.9( h)

Physical or operational change 60.7( x)( 4), 61.15,

Opacity or visible emissions 63.10( d)( 3)

Periodic start up, shutdown, malfunction reports 63.10( d)( 5)( I)

Source status report 61.10( x), 63.1439( e)( 5) A source must maintain the following records:

Recordkeeping for 40 CFR, Part 63.1439, Subpart PPP Start ups, shutdowns, malfunctions, periods where the ( 60.7( b), 63.10( b)(

Emission test results and other data needed to determine emissions 61.13( g)

All reports and notifications Record of applicability 63.10( b)( 3)

Records for sources with continuous monitoring systems 63.10( 3)

Records are required to be retained for 5 Years. 63.1439( a) 7 ( ii.) Respondent Activities Respondent Activities Read instructions.

Install, calibrate, maintain, and operate CMS for opacity, or for pressure drop and liquid supply pressure for 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 otherwise disclose the information.

5. 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, and excess emissions reports, required to be submitted by industry.

Audit facility records.

Input, analyze, and maintain data in the AIRS ( Aerometric Information Retrieval system)

Facility subsystem ( AFS) database 8 5( b) Collection Methodology and Management Following notification of start up, 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 standards. 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.

5( c) Small Entity Flexibility Six of the 83 affected facilities in this source category are small businesses. The Agency does not expect that any polyester polyols production facilities, including the small businesses,,

would experience adverse impacts related to the cost of the required reporting and recordkeeping.

5( d) Collection Schedule The specific frequency for each information collection activity within this request is shown in Table 2: Industry Burden.

6. Estimating the Burden and Cost of the Collection Table 2 documents the computation of individual burdens for the recordkeeping and reporting requirements applicable to the industry for Subpart PPP 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 9 The average annual burden to industry over the next three years from these recordkeeping and reporting requirements is estimated to be 88,860 ( Total Labor Hours from Table 2). 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 This ICR uses a Technical Labor Rate of $ 55.34 per hour, $ 78.54 per hour for Executive, Administrative, and Managerial labor; $ 55.34 per hour for Technical labor, and $ 35.64 per hour for Clerical labor. These rate( s)] are from the United States Department of Commerce Bureau of Labor Statistics, March 2000, " Table 10. Private industry, by occupational and industry group." The rates are from column 1, " Total compensation." The wage rate( s) have been increase by 110% to account for the benefit packages available to those employed by private industry.

( ii) Estimating Capital/ Startup and Operation and Maintenance Costs Capital costs for information collection at polyester polyols production facilities are only associated with purchasing equipment an supplies, and equipment installation and maintenance for process vent monitoring. Equipment costs are annualized over 5 years at 10 percent interest.

The capital costs, assumed to be a one time cost for the life of the equipment, were estimated to be $ 9,385 per source. The total costs for the first year 80 plants are $ 750,800.

The only type of industry costs associated with the information collection activity in the regulations are labor costs. 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 10 The total capital/ startup costs for this ICR are $ 513,051. These costs are shown in block 14( a), Total annualized capital/ startup costs, on the OMB 83 I form. It should be noted that the numbers in block 14 of the OMB 83 I form are rounded to show the cost in thousands of dollars.

The total operation and maintenance ( O& M) costs for this Information Collection Request ( ICR) is zero. This cost is shown in block 14( b), Total annual costs ( O& M), on the OMB 83 I form.

The total respondent non labor costs in block 14 have been calculated as the addition of the capital/ startup costs, and the annual operation and maintenance costs. 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 $ 513,051 . This cost is shown on the OMB 83 I form in block 14 ( c), Total annualized cost requested. The numbers in block 14 of the OMB 83 I form are rounded to show the cost in thousands of dollars.

6( c) Estimating Agency Burden and Cost The only costs to the Agency are those costs associated with analysis of the reported information. Publication and distribution of the information are part of the AFS program. Examination of records to be maintained by the respondents will occur as part of the periodic inspection of sources,

which is part of EPA's overall, compliance and enforcement program. The average annual Agency cost during the 3 years of the ICR is estimated to be $ 16,201. 6( d) Estimating the Respondent Universe and Total Burden and Costs. The number of total respondents is 82. This number is the sum of Column A and Column C of the Respondent Universe table. This represents the number of existing sources plus the number of new sources averaged over the three year period. It is shown in block 13 ( a), Number of respondents, on the OMB 83 I form.

6( d) Estimating the Respondent Universe and Total Burden and Costs 11 The number of Total Annual Responses is 158. It is shown in block 13 ( b), Total annual responses, on the OMB 83 I form. The total annual hours requested 88,680. Only the burden hours are reflected in block 13( c). Details upon which this estimate is based appear in Table 2.

The total annual capital and O& M costs to the regulated entity are $ 513,051. This number is shown on the OMB 83 1 form in block 14 ( c), Total annualized cost requested.

6( e) Bottom Line Burden Hours And Cost Tables ( i) Respondent Tally  The number of respondent tally is 82. This number reflects the number of existing sources ( 79) plus one new source over the next three years.

( ii) The Agency Tally As shown in Table B , the only costs ( 16,670) to the Agency are those annual costs to implement reporting and recordkeeping requirements associated with analysis of the reporting information.

( iii) Variations in the Annual Bottom Line  The difference in the adjustment as noted on OMB 83 1 form 13( e) is due to a projected facility growth of one facility per year over the next three years.

The bottom line burden hours and cost tables for both the Respondents and the Agency are attached . ( Table 2A estimated burden and labor costs for respondents and Table 2B estimate of annual burden and costs respectively).

6( f) Reasons for Change in Burden The increase in burden from the most recently approved ICR is due to an increase in the number of projected new sources over the next three years.

6( g) Burden Statement 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 12 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 currently valid OMB control number. The OMB control numbers for EPA's standards are listed in 40 CFR Part 9 and 48 CFR Chapter 15.

Send comments on the Agency's need for this information, the accuracy of the provided burden estimates, and any suggested methods for minimizing respondent burden, including through the use of automated collection techniques to the Ms. Susan Auby, Collection Strategies Division ( Mail Code 2822T), Office of Environmental Information, United States Environmental Protection Agency, 1200 Pennsylvania Avenue, NW, Washington, D. C. 20460

0001; and to the Office of Information and Regulatory Affairs, Office of Management and Budget, 725 17th Street, NW, Washington, DC 20503, Attention: Desk Officer for EPA.

Include the EPA ICR number and OMB Control Number in any correspondence.

ATTACHMENT 1 Source Data and Information Requirements 13 PART B OF THE SUPPORTING STATEMENT This section is not applicable because statistical methods are not used in the data collection associated with this regulation.

SUMMARY OF RECORDKEEPING REQUIREMENTS ' Requirements Regulation reference Record keeping Requirements 63.10 40 CFR 63 Subpart A Notification of Compliance Status 63.9( h), 40 CFR 63 Subpart A Process changes 63.115( e), 40 CFR Subpart G Maximum condenser outlet as temperature 63.1429( a)

Flare pilot flame presence 63.1140 CFR 63 Subpart A 63.1255( b)

Wastewater management unit parameters to be monitored 63.1434 LDAR records 63.1434 Maximum exceedances 63.1438 SUMMARY OF REPORTING REQUIREMENTS Requirement Relation Reference Reporting results of performance tests 63.10 d 2 40 CFR 63 Subpart A Periodic startup, shutdown, and malfunction reports 63.10( d)( 5) 40 CFR 63 Subpart A Quarterly excess emissions reports 63.10( e)( 3) 40 CFR 63 Subpart A Process, vents reporting requirements 63.1430 Storage vessel reporting requirements 63.1432 Wastewater reporting requirements 63.1433 LDAR reporting requirements 63.1434 General reporting requirements 63.1439 14 ATTACHMENT 2 Description of Respondent Activities ( 1) Read Rule and Instructions are the activities, less training, which involve comprehending the provisions in the standard and understanding how they apply to the respective points at a facility.

( 2) Plan Activities represents such burdens as design, redesign, scheduling as well as drafting the implementation plan, and selecting methods of compliance.

( 3) Training represents the portion ( assumed 40%) of activities from ( 1) Read Rule and Instruction which an average facility would elect to provide classroom instructions for. The standard does not require specific training itself.

( 4) Create, Test, and Research and Development are the activities involving testing, retesting,

establishing operating range parameters and analyzing pint by point applicability. Monitor related refit, calibration, and maintenance activities are also included under this heading.

( 5) Gather Information, Monitor, and Inspect are the activities involving physical inspections of equipment, collection of monitored dates and other related activities. This estimate does not include the monitoring of equipment leak components. The cost for monitoring equipment leak components is included as part of the cost of the leak detection and repair program.

( 6) Process/ Compile and Review are the activities that involve analysis of the information collected for accuracy, compliance, and appropriate reports and records required as a result.

( 7) Complete Reports represents the activities normally associated with filling out forms. Since the standard requires no standard forms, these activities relate to the preparing of formal reports and cover letters as appropriate.

( 8) Record/ Disclose are activities that are solely record keeping that occur once the appropriate report information has been extracted. These activities involve software translation, duplication,

or archival processes normally associated with data management and storage common to this industry.

( 9) Store/ File are again activities that are solely record keeping that occur once the appropriate report information has been extracted. The activities involve the management life cycle of 15 records, from the time they are filed and boxed up to the time they are disposed of.

TOTAL BURDEN AND COST is the sum of each of the columns ( e), ( f), ( g), and ( h).


[Federal Register: April 7, 2009 (Volume 74, Number 65)]
[Notices]
[Page 15803-15804]
[DOCID:fr07ap09-134]

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SECURITIES AND EXCHANGE COMMISSION

[Release No. 34-59678; File No. SR-NYSEArca-2009-14]

Self-Regulatory Organizations; NYSE Arca, Inc.; Order Granting
Accelerated Approval of a Proposed Rule Change Relating to the Leverage
Factor Applicable to the MacroShares Major Metro Housing Trusts

April 1, 2009.
    On March 3, 2009, NYSE Arca, Inc. (``NYSE Arca'' or ``Exchange''),
through its wholly owned subsidiary, NYSE Arca Equities, Inc. (``NYSE
Arca Equities''), filed with the Securities and Exchange Commission
(``Commission'') pursuant to Section 19(b)(1) of the Securities
Exchange Act of 1934 (``Act'') \1\ and Rule 19b-4 thereunder,\2\ a
proposed rule change to modify the representation made in SR-NYSEArca-
2008-92 \3\ regarding the leverage factor applicable to the MacroShares
Major Metro Housing Up Trust (``Up Trust'') and the MacroShares Major
Metro Housing Down Trust (``Down Trust'') (collectively, the
``Trusts'') and, specifically, to indicate that the leverage factor to
be applied will be 3 rather than 2.\4\ The proposed rule change was
published in the Federal Register on March 16, 2009 for a 15-day
comment period.\5\ The Commission received no comments on the proposal.
This order grants approval to the proposed rule change on an
accelerated basis.
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    \1\ 15 U.S.C. 78s(b)(1).
    \2\ 17 CFR 240.19b-4.
    \3\ See Securities Exchange Act Release No. 58704 (October 1,
2008), 73 FR 59026 (October 8, 2008) (order approving listing and
trading on the Exchange of the Trusts (``Approval Order'')); See
also Securities Exchange Act Release No. 58469 (September 5, 2008),
73 FR 53306 (September 15, 2008) (SR-NYSEArca-2008-92) (notice of
proposed rule change to list and trade the Trusts on the Exchange)
(``Initial Notice''). The Shares are being offered by the Trusts
under the Securities Act of 1933, 15 U.S.C. 77a. On February 17,
2009, the depositor filed with the Commission preliminary
Registration Statements on Form S-1 (Amendment No. 3) for the Up
MacroShares (File No. 333-151522) and for the Down MacroShares (File
No. 333-151523) (``Registration Statements'').
    \4\ Shares of the Up Trust and the Down Trust are referred to
collectively as ``Shares.''
    \5\ See Securities Exchange Act Release No. 59542 (March 9,
2009), 74 FR 11167 (``Notice'').
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I. Description of the Proposal

    The Commission previously approved, pursuant to Section 19(b)(2) of
the Act, the Exchange's proposal to list and trade the Up MacroShares
and the Down MacroShares as Paired Trust Shares under NYSE Arca
Equities Rule 8.400.\6\
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    \6\ See Approval Order, supra note 3.
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    As described in the Approval Order and the Initial Notice, the Up
Trust and the Down Trust intend to issue Up MacroShares and Down
MacroShares, respectively, on a continuous basis. The Up MacroShares
and the Down MacroShares represent undivided beneficial interests in
the Up Trust and the Down Trust, respectively.
    The Trusts will make quarterly distributions and a final
distribution that is based on the value of the S&P/Case-Shiller
Composite-10 Home Price Index (``Index''), as well as on prevailing
interest rates on U.S. Treasury obligations. The last published value
of the S&P/Case-Shiller Composite-10 Home Price Index is referred to as
the ``Reference Value of the Index'' or ``Reference Value'', as
discussed in the Initial Notice.\7\
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    \7\ The Reference Value of the Index is the Reference Price for
purposes of NYSE Arca Equities Rule 8.400.
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    If the Reference Value rises above its specified starting level,
the Up Trust's Underlying Value (as described in the Initial Notice)
will increase to include all of its assets plus a portion of the assets
of the paired Down Trust. This portion of assets due from the Down
Trust will be multiplied by a specified ``leverage factor.''
Conversely, if the level of the Reference Value of the Index falls
below its starting level on and after the closing date, the Up Trust's
Underlying Value will decrease, because a portion of its assets will be
included in the Underlying Value of its paired Down Trust, such portion
being multiplied by the leverage factor.
    The Initial Notice stated that the leverage factor would be 2, as
initially described in the Registration Statements. The Trusts now
intend to utilize a leverage factor of 3.\8\ The effect of this will be
to triple any increase or decrease in the Underlying Value of the Up
Trust or the Down Trust, depending upon whether there is an increase or
decrease in the Reference Value of the Index.
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    \8\ With the exception of the proposed change to the leverage
factor, and a change in the distribution date from a date in 2018 to
a date in 2014, the Exchange states that all representations made by
the Exchange in the Initial Notice continue to apply. See Notice,
supra note 5, 74 FR at 11168, n. 8.
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    Additional information relating to the Trusts and Shares is
available in the Registration Statements, the Notice, the Initial
Notice and the Approval Order.\9\
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    \9\ See supra notes 3 and 5.
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II. Discussion and Commission's Findings

    The Commission has carefully reviewed the proposed rule change and
finds that it is consistent with the

requirements of Section 6 of the Act \10\ and the rules and regulations
thereunder applicable to a national securities exchange.\11\ In
particular, the Commission finds that the proposal is consistent with
Section 6(b)(5) of the Act,\12\ which requires, among other things,
that the Exchange's rules be designed to prevent fraudulent and
manipulative acts and practices, to promote just and equitable
principles of trade, to foster cooperation and coordination with
persons engaged in regulating, clearing, settling, processing
information with respect to, and facilitating transaction in
securities, to remove impediments to and perfect the mechanism of a
free and open market and a national market system, and, in general, to
protect investors and the public interest.
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    \10\ 15 U.S.C. 78f.
    \11\ In approving this proposed rule change the Commission has
considered the proposed rule's impact on efficiency, competition,
and capital formation. See 15 U.S.C. 78c(f).
    \12\ 15 U.S.C. 78f(b)(5).
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    The Commission notes that it has previously approved the listing
and trading of the Trusts under NYSE Arca Equities Rule 8.400.\13\ The
Commission also notes that the Exchange has represented that, with the
exception of the change to the leverage factor applicable to the
Trusts, and a change to the distribution date, all prior
representations made in the Initial Notice will continue to apply.\14\
This approval order is based on the Exchange's representations.
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    \13\ See Approval Order, supra note 3.
    \14\ See supra notes 5 and 8.
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    The Commission believes that the increase from 2 to 3 of the
leverage factor applicable to the Up MacroShares and the Down
MacroShares, respectively, is reasonable to facilitate the listing and
trading of the Shares. Additionally, the Commission believes that the
increase of the leverage factor should help to increase competition
among market participants and benefit investors. The Commission also
notes that it has previously approved the listing and trading of other
exchange-traded products with up to 300% leverage.\15\
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    \15\ See e.g., Securities Exchange Act Release Nos. 58825
(October 21, 2008), 73 FR 63756 (October 27, 2008) (SR-NYSEArca-
2008-89) (approving amendment to Rule 5.2(j)(3) to permit listing of
Investment Company Units where the issuer seeks to provide
investment results, before fees and expenses, up to -300% of the
percentage performance on a given day of a particular equity index);
59332 (January 30, 2009), 74 FR 6338 (February 2, 2009) (SR-
NYSEArca-2008-136) (approving amendment to NYSE Arca Equities Rule
5.2(j)(6) to permit a loss or negative payment at maturity with
respect to an issue of Index-Linked Securities to be accelerated by
a multiple up to three times the performance of an underlying
Reference Asset, as defined in NYSE Arca Equities Rule 5.2(j)(6)).
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III. Accelerated Approval

    The Commission finds good cause, pursuant to Section 19(b)(2) of
the Act,\16\ for approving the proposal prior to the thirtieth day
after the date of publication of the Notice in the Federal Register.
The Commission has received no comments regarding the proposed rule
change, and the Commission finds that the proposed rule change does not
raise any novel regulatory issues. Additionally, the Commission
believes that accelerating approval of this proposal should benefit the
market by making available to investors, without undue delay,
additional products in the market for Paired Trust Shares.
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    \16\ 15 U.S.C. 78s(b)(2).
---------------------------------------------------------------------------

IV. Conclusion

    It is therefore ordered, pursuant to Section 19(b)(2) of the
Act,\17\ that the proposed rule change (SR-NYSEArca-2009-14) be, and it
hereby is, approved on an accelerated basis.
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    \17\ Id.

    For the Commission, by the Division of Trading and Markets,
pursuant to delegated authority.\18\
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    \18\ 17 CFR 200.30-3(a)(12).
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Florence E. Harmon,
Deputy Secretary.
 [FR Doc. E9-7775 Filed 4-6-09; 8:45 am]

BILLING CODE 8010-01-P


[Federal Register Volume 77, Number 44 (Tuesday, March 6, 2012)]
[Proposed Rules]
[Pages 13228-13230]
[FR Doc No: 2012-5379]

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DEPARTMENT OF TRANSPORTATION

Federal Aviation Administration

14 CFR Part 39

[Docket No. FAA-2012-0188; Directorate Identifier 2011-NM-120-AD]
RIN 2120-AA64

Airworthiness Directives; BAE SYSTEMS (Operations) Limited
Airplanes

AGENCY: Federal Aviation Administration (FAA), DOT.

ACTION: Notice of proposed rulemaking (NPRM).

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SUMMARY: We propose to adopt a new airworthiness directive (AD) for all
BAE SYSTEMS (Operations) Limited Model 4101 airplanes. This proposed AD
was prompted by reports of cracking found in the wing rear spar. This
proposed AD would require a one-time detailed inspection for cracks,
corrosion, and other defects of the rear face of the wing rear spar,
and repair if necessary. We are proposing this AD to detect and correct
cracking in the rear spar, which could propagate to a critical length,
possibly affecting the structural integrity of the area and resulting
in a fuel tank rupture, with consequent damage to the airplane and
possible injury to its occupants.

DATES: We must receive comments on this proposed AD by April 20, 2012.

ADDRESSES: You may send comments by any of the following methods:
     Federal eRulemaking Portal: Go to http://www.regulations.gov. Follow the instructions for submitting comments.
     Fax:<PHONE_NUMBER>.
     Mail: U.S. Department of Transportation, Docket
Operations, M-30, West Building Ground Floor, Room W12-140, 1200 New
Jersey Avenue SE., Washington, DC 20590.
     Hand Delivery: U.S. Department of Transportation, Docket
Operations, M-30, West Building Ground Floor, Room W12-140, 1200 New
Jersey Avenue SE., Washington, DC, between 9 a.m. and 5 p.m., Monday
through Friday, except Federal holidays.
    For service information identified in this proposed AD, contact BAE
SYSTEMS (Operations) Limited, Customer Information Department,
Prestwick International Airport, Ayrshire, KA9 2RW, Scotland, United
Kingdom; telephone +44 1292 675207; fax +44 1292 675704; email
<EMAIL_ADDRESS>Internet http://www.baesystems.com/Businesses/RegionalAircraft/index.htm. You may review copies of the
referenced service information at the FAA, Transport Airplane
Directorate, 1601 Lind Avenue SW., Renton, Washington. For information
on the availability of this material at the FAA, call<PHONE_NUMBER>.

Examining the AD Docket

    You may examine the AD docket on the Internet at http://www.regulations.gov; or in person at the Docket Operations office
between 9 a.m. and 5 p.m., Monday through Friday, except Federal
holidays. The AD docket contains this proposed AD, the regulatory
evaluation, any comments received, and other information. The street
address for the Docket Operations office (telephone<PHONE_NUMBER>) is
in the ADDRESSES section. Comments will be available in the AD docket
shortly after receipt.

FOR FURTHER INFORMATION CONTACT: Todd Thompson, Aerospace Engineer,
International Branch, ANM-116, Transport Airplane Directorate, FAA,
1601 Lind Avenue SW., Renton, Washington 98057-3356; telephone 425-227-
1175; fax<PHONE_NUMBER>.

SUPPLEMENTARY INFORMATION:

Comments Invited

    We invite you to send any written relevant data, views, or
arguments about this proposed AD. Send your comments to an address
listed under the ADDRESSES section. Include ``Docket No. FAA-2012-0188;
Directorate Identifier 2011-NM-120-AD'' at the beginning of your
comments. We specifically invite comments on the overall regulatory,
economic, environmental, and energy aspects of this proposed AD. We
will consider all comments received by the closing date and may amend
this proposed AD based on those comments.
    We will post all comments we receive, without change, to http://www.regulations.gov, including any personal information you provide. We
will also post a report summarizing each substantive verbal contact we
receive about this proposed AD.

Discussion

    The European Aviation Safety Agency (EASA), which is the Technical
Agent for the Member States of the European Community, has issued EASA
Airworthiness Directive 2011-0096, dated May 25, 2011 (referred to
after this as ``the MCAI''), to correct an unsafe condition for the
specified products. The MCAI states:

    Four cracks were found on a wing rear spar by an operator during
a fuel leak investigation. The cracks were located between ribs 6
and 7, immediately inboard of the inboard engine rib. The cracks
initiated at adjacent fastener bores in the rear spar

upper boom and progressed downwards, diagonally, into the rear spar
web.
    Such cracking in the rear spar, if not detected and corrected,
could propagate to a critical length, possibly affecting the
structural integrity of the area and/or resulting in a fuel tank
rupture, and consequent damage to the aeroplane and injury to its
occupants.
    For the reasons described above, this [EASA] AD requires a one-
time [detailed] inspection [for cracks, corrosion, and other
defects] of the rear face of the wing rear spar and the
accomplishment of the associated corrective actions [i.e., repair],
depending on findings.

You may obtain further information by examining the MCAI in the AD
docket.

Relevant Service Information

    BAE SYSTEMS (Operations) Limited has issued Alert Service Bulletin
J41-A57-029, dated May 6, 2011; and Subject 57-00-00, Wings General, of
Chapter 57, Wings, of the Jetstream Series 4100 Structural Repair
Manual, Volume 1, Revision 30, dated April 15, 2007. The actions
described in this service information are intended to correct the
unsafe condition identified in the MCAI.

FAA's Determination and Requirements of This Proposed AD

    This product has been approved by the aviation authority of another
country, and is approved for operation in the United States. Pursuant
to our bilateral agreement with the State of Design Authority, we have
been notified of the unsafe condition described in the MCAI and service
information referenced above. We are proposing this AD because we
evaluated all pertinent information and determined an unsafe condition
exists and is likely to exist or develop on other products of the same
type design.

Costs of Compliance

    Based on the service information, we estimate that this proposed AD
would affect about 3 products of U.S. registry. We also estimate that
it would take about 25 work-hours per product to comply with the basic
requirements of this proposed AD. The average labor rate is $85 per
work-hour. Based on these figures, we estimate the cost of the proposed
AD on U.S. operators to be $6,375, or $2,125 per product.
    We have received no definitive data that would enable us to provide
a cost estimates for the on-condition actions (repairing cracks,
corrosion, and defects) specified in this AD.

Authority for This Rulemaking

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

Regulatory Findings

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

List of Subjects in 14 CFR Part 39

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

The Proposed Amendment

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

PART 39--AIRWORTHINESS DIRECTIVES

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

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

Sec.  39.13  [Amended]

    2. The FAA amends Sec.  39.13 by adding the following new AD:

BAE SYSTEMS (Operations) Limited: Docket No. FAA-2012-0188;
Directorate Identifier 2011-NM-120-AD.

(a) Comments Due Date

    We must receive comments by April 20, 2012.

(b) Affected ADs

    None.

(c) Applicability

    This AD applies to BAE SYSTEMS (Operations) Limited Model 4101
airplanes, certificated in any category, all models, and all serial
numbers.

(d) Subject

    Air Transport Association (ATA) of America Code 57: Wings.

(e) Reason

    This AD was prompted by reports of cracking found in the wing
rear spar. We are issuing this AD to detect and correct cracking in
the rear spar, which could propagate to a critical length, possibly
affecting the structural integrity of the area and resulting in a
fuel tank rupture, with consequent damage to the airplane and
possible injury to its occupants.

(f) Compliance

    You are responsible for having the actions required by this AD
performed within the compliance times specified, unless the actions
have already been done.

(g) Detailed Inspection and Repair

    Within 300 flight hours after the effective date of this AD, or
before further flight if a fuel leak is detected in the vicinity of
a wing rear spar, whichever occurs first: Do a detailed inspection
for cracks, corrosion, and other defects (defects include scratches,
dents, holes, damage to fastener holes, or damage to surface
protection and finish) of the rear face of the wing rear spars, in
accordance with the Accomplishment Instructions of BAE SYSTEMS Alert
Service Bulletin J41-A57-029, dated May 6, 2011.
    (1) If any cracking, corrosion, or other defect is found to be
within the criteria defined in Subject 57-00-00, Wings General, of
Chapter 57, Wings, of the Jetstream Series 4100 Structural Repair
Manual, Volume 1, Revision 30, dated April 15, 2007: Before further
flight, repair the damage, in accordance with the repair
instructions specified in Subject 57-00-00, Wings General, of
Chapter 57, Wings, of the Jetstream Series 4100 Structural Repair
Manual, Volume 1, Revision 30, dated April 15, 2007.
    (2) If any cracking, corrosion, or other defect is found
exceeding the criteria as specified in Subject 57-00-00, Wings
General, of Chapter 57, Wings, of the Jetstream Series 4100
Structural Repair Manual, Volume 1, Revision 30, dated April 15,
2007: Before further flight, repair the condition, in accordance
with a method approved by the Manager, International

Branch, ANM-116, Transport Airplane Directorate, FAA, or EASA (or
its delegated agent).

(h) Reporting

    Submit a report of the findings of the inspection required by
paragraph (g) of this AD, including a report of no defects, to BAE
SYSTEMS (Operations) Limited, Customer Information Department,
Prestwick International Airport, Ayrshire, KA9 2RW, Scotland, United
Kingdom; telephone +44 1292 675207; fax+44 1292 675704; email
<EMAIL_ADDRESS>Internet http://www.baesystems.com/Businesses/RegionalAircraft/index.htm, at the applicable time
specified in paragraph (h)(1) or (h)(2) of this AD.
    (1) If the inspection was done on or after the effective date of
this AD: Submit the report within 30 days after the inspection.
    (2) If the inspection was done before the effective date of this
AD: Submit the report within 30 days after the effective date of
this AD.

(i) Other FAA AD Provisions

    The following provisions also apply to this AD:
    (1) Alternative Methods of Compliance (AMOCs): The Manager,
International Branch, ANM-116, Transport Airplane Directorate, FAA,
has the authority to approve AMOCs for this AD, if requested using
the procedures found in 14 CFR 39.19. In accordance with 14 CFR
39.19, send your request to your principal inspector or local Flight
Standards District Office, as appropriate. If sending information
directly to the International Branch, send it to ATTN: Todd
Thompson, Aerospace Engineer, International Branch, ANM-116,
Transport Airplane Directorate, FAA, 1601 Lind Avenue SW., Renton,
Washington 98057-3356; telephone<PHONE_NUMBER>; fax<PHONE_NUMBER>.
Information may be emailed to<EMAIL_ADDRESS>
Before using any approved AMOC, notify your appropriate principal
inspector, or lacking a principal inspector, the manager of the
local flight standards district office/certificate holding district
office. The AMOC approval letter must specifically reference this
AD.
    (2) Airworthy Product: For any requirement in this AD to obtain
corrective actions from a manufacturer or other source, use these
actions if they are FAA-approved. Corrective actions are considered
FAA-approved if they are approved by the State of Design Authority
(or their delegated agent). You are required to assure the product
is airworthy before it is returned to service.
    (3) Reporting Requirements: A federal agency may not conduct or
sponsor, and a person is not required to respond to, nor shall a
person be subject to a penalty for failure to comply with a
collection of information subject to the requirements of the
Paperwork Reduction Act unless that collection of information
displays a current valid OMB Control Number. The OMB Control Number
for this information collection is 2120-0056. Public reporting for
this collection of information is estimated to be approximately 5
minutes per response, including the time for reviewing instructions,
completing and reviewing the collection of information. All
responses to this collection of information are mandatory. Comments
concerning the accuracy of this burden and suggestions for reducing
the burden should be directed to the FAA at: 800 Independence Ave.
SW., Washington, DC 20591, Attn: Information Collection Clearance
Officer, AES-200.

(j) Related Information

    Refer to MCAI EASA Airworthiness Directive 2011-0096, dated May
25, 2011, and the service information specified in paragraphs (k)(1)
and (k)(2) of this AD; for related information.
    (1) BAE SYSTEMS Alert Service Bulletin J41-A57-029, dated May 6,
2011.
    (2) Subject 57-00-00, Wings General, of Chapter 57, Wings, of
the Jetstream Series 4100 Structural Repair Manual, Volume 1,
Revision 30, dated April 15, 2007.

    Issued in Renton, Washington, on February 27, 2012.
Kalene C. Yanamura,
Acting Manager, Transport Airplane Directorate, Aircraft Certification
Service.
[FR Doc. 2012-5379 Filed 3-5-12; 8:45 am]
BILLING CODE 4910-13-P


Application of Measures of Spontaneous Motor Activity for Behavioral Assessment in Human Infants   Pilot Study Section 1.

A. Supporting Statement 1. Identification of the Information Collection 1( a) Title Application of Measures of Spontaneous Motor Activity for Behavioral Assessment in Human Infants   Pilot Study EPA ICR Number 2166.01 1( b) Abstract The U. S. Environmental Protection Agency ( EPA) is participating in the planning of the National Children's Study ( NCS), a congressionally mandated study to examine the effects of environmental influences on the health and development of children from before birth until age 21. The goal of the NCS, which has been in the planning stages for several years, is to improve the health and well being of children. One EPA responsibility is to identify and test various data collection methods being considered for the NCS, including those to investigate developmental disorders that may be associated with exposure to environmental agents. Issues associated with environmental exposures are particularly important in light of research that has linked prenatal and early childhood exposure to certain neurotoxicants ( including lead, mercury, manganese, and polychlorinated biphenyls ( PCBs)) with negative behavioral outcomes. The potential association between the large increase in the number of children diagnosed with conditions such as attention deficit hyperactivity disorder ( ADHD) and environmental exposures is of particular concern to the EPA. Early detection of exposure to neurotoxicants is critical because infants' and toddlers' neurologic systems are in the beginning stages of development and exposures can lead to long term or lifelong defects. The EPA proposes this information collection to help advance the ability to detect, prevent and treat such negative outcomes. 2. Need for and use of the Collection 2( a) Need / Authority for the Collection The goal of the proposed information collection is to test a method to collect data that would be used to quantitatively characterize spontaneous motor activity in young children between the ages of 6 and 24 months. This information is needed to help plan and design the National Children's Study. The authority for this Collection derives from the Children's Health Act of 2000 ( PL 106 310). This law specifically authorizes the conduct of a national longitudinal study of environmental influences on children's health and development and directs the participation of EPA in this effort. 2( b) Practical Utility/ Users of the Data Data from the study will be used to 1) identify sources of variance in infants' and toddlers' daily activity levels, 2) estimate the number of days of activity measurement that would be necessary to reliably quantify these activities, and 3) investigate the potential association between activity measures averaged over long periods of time and activity measures averaged over the duration of a specific event. Data will be analyzed and used to help EPA determine the best way to gather reliable data to further examine the effects of exposure to environmental contaminants on young children's development. The results of this analysis will be shared with the NCS planning group via the Interagency Coordinating Committee ( ICC). 2 3. Non duplication, Consultations and Other Collection Criteria 3( a) Non duplication To ensure that no other sources of information could sufficiently address the measurement of spontaneous activity among infants and toddlers, an extensive review of the literature was conducted. The literature revealed that:   actigraphy has been used extensively in assessing physical activity and sleep patterns with adults and adolescents, but not young children;   actigraphy has been used successfully with children between the ages of 3 and 6 years in efforts to understand childhood obesity; and   studies have used actigraphy with infants and toddlers to measure sleep/ wake cycles. No studies, however, have been conducted that provide information on the issues EPA needs to address for the NCS. 3( b) Public Notices Required Prior to ICR Submission to OMB The announcement of a public comment period for this ICR was published in the Federal Register on November 2, 2004. No comments were received. 3( c) Consultations The following individuals were consulted about the overall design of this project: Amy Branum, MSPH, National Center for Health for Health Statistics, CDC Adolfo Correa, MD, PhD, National Center on Birth Defects and Developmental Disabilities, CDC Sarah Keim, MA, National Institute of Child Health and Human Development, NIH Woodie Kessel, MD, MPH, Office of the Secretary, Department of Health and Human Services Carole A. Kimmel, PhD, National Center for Environmental Assessment, EPA Mark Klebanoff, MD, MPH, National Institute of Child Health and Human Development, NIH Pauline Mendola, PhD, National Health and Environmental Effects Research Laboratory, EPA Sheila A. Newton, MS, PhD, National Institute of Environmental Health Sciences, NIH James J. Quakenboss, MS, National Exposure Research Laboratory, EPA Peter C. Scheidt, MD, MPH, National Institute of Child Health and Human Development, NIH Kenneth Schoendorf, MD, MPH, National Center for Health Statistics, CDC Sherry G. Selevan, PhD, National Center for Environmental Assessment, EPA Marshalyn Yeargin Allsopp, MD, National Center on Birth Defects and Developmental Disabilities, CDC The following individual was consulted about the statistical portions of this project: Abhik Das, Ph. D., Statistics Research Division, RTI International 3( d) Effects of Less Frequent Collection This is a one time collection. 3( e) General Guidelines There are no special circumstances that require this collection to be conducted in a manner inconsistent with OMB's general guidelines. 3( f) Confidentiality All staff involved with data collection will be trained on confidentiality and be required to sign confidentiality pledges. Identification numbers will be assigned to each child participating in the study. Names and other identifying information will not be included in or with the data collected from the accelerometer. All data will be stored in secure computers and storage facilities. 3( g) Sensitive Questions 3 No sensitive questions will be asked. 4. The Respondents and the Information Requested 4( a) Respondents/ SIC Codes This study will be conducted using 110 parent child pairs. The children will be recruited in two groups of 54 56, each with approximately equal numbers of boys and girls. One group will be comprised of infants 6   12 months of age. The other will be comprised of toddlers 19 24 months of age. 4( b) Information Requested ( i) Data items, including record keeping requirements Data will be collected in the following way. Parent child dyads will be invited to a laboratory for an initial visit, where the study examiner will obtain consent and place a small, lightweight device called an accelerometer on the child's waist. Children will wear the accelerometer, which produces activity measures, for a 7 day monitoring period ( day and night). After the accelerometer has been placed, the parent will complete either the Infant Behavioral Questionnaire ( IBQ) ( for children 12 months of age and younger) or the Infant Toddler Social and Emotional Assessment ( ITSEA) ( for children over the age of 12 months). Results will be used to assess the child's temperament. During the lab visit, the study examiner will administer the Peabody Developmental Motor Scale, 2nd Edition ( PDMS 2) to the child; any child not falling into the normal range of development will not be asked to continue in the study. ( Attachment 2 has information on the IBQ, ITSEA, and PDMS 2.) Children continuing in the study will participate in a brief unstructured play activity before leaving the lab. ( ii) Respondent Activities If a child is in the normal range of development, the parent will be provided with a 7 day Time Activity Diary ( see Attachment 1), on which the parent will record the beginning and ending time of each activity, using a list of coded responses. At 48 hour intervals, the study examiner will visit the child's home to retrieve accelerometer data. At the end of the 7 day data collection period, the study examiner will visit the home of each dyad to collect the accelerometer and time activity diary 5. The Information Collected   Agency Activities, Collection Methodology, and Information Management 5( a) Agency Activities EPA's Human Studies Division, Epidemiology and Biomarkers Branch will be responsible for subject recruitment, eligibility screening and enrollment, accelerometer instruction and placement, data analysis and review. 5( b) Collection Methodology and Management This project will use multiple methods of data collection: lab assessments, actigraphy data ( collected from the accelerometer), and activity diaries. Data on each child's temperament ( IBQ or BITSEA) and motor development ( PDMS 2) will be collected in the laboratory by trained technicians on day one of the study. Motor activity data will be collected by an accelerometer device ( Actiwatch AW 64, Mini Mitter Co., Inc, Bend, Oregon) worn by the child for the 7 day monitoring period. Time activity data will be collected by parent completion of a time activity diary for the seven day monitoring period. Accelerometer data will be downloaded directly to a computer file via a docking station. IBQ/ BITSEA and PDMS 2 data will be converted to electronic files and entered into a data base. Time activity data will be converted to electronic format and entered into a data base. 4 Because of the exploratory nature of this study, most analyses of the actigraphy produced data will be descriptive, including mean counts of activity in various categories ( e. g., per minute, per minute while awake, per minute while asleep, and per minute for specific activities). Summary measures will be calculated for various age cohorts, for the entire data collection period and for each day within the period. Summaries of activity for other periods of time ( e. g., hourly) and gender specific analyses also will be prepared. All measures of activity will be categorized according to events recorded in diaries that will be classified as sedentary, light, moderate, and vigorous. Access to all data will be controlled in accordance with Federal privacy regulations and OMB Circular A 110. 5( c) Small Entity Flexibility No small entities will be affected by this collection. 5( d) Collection Schedule Task Date IRB Approval February 2005 OMB approval June 2005 Participant recruitment June 2005   September 2005 Field staff training May 2005 Data collection June 2005   October 2005 Data analysis November 2005   January 2006 Interim Report December 2005 Final Report March 2006 6. Estimating the Burden and Cost of the Collection 6( a) Estimating Respondent Burden Anticipating 10% attrition, the study will enroll 110 respondents to get 100 complete accelerometer readings and time activity diaries. The annualized hour burden reported in Table 1 was computed as follows:   According to the developer, conducting the PDMS 2 motor assessment for one child takes, on average, 45 minutes.   Conducting the IBQ or ITSEA temperament assessments for one child takes, on average, 30 minutes.   An adult will spend about 45 minutes per day, for each of 7 days, to enter information into the activity diary.   The adult will spend 30 minutes, on average, when a staff member visits the home to collect study materials and equipment.   The most recent average national wage provided by the Bureau of Labor Statistics is $ 17 per hour ( U. S. Department of Labor, 2003). 5 Table 1. Estimated Annualized Respondent Burden Form Number of Participants Number of Responses per Participant Hours per Response Total Response Burden ( Hours) Average Hourly Wage in Dollars Total Average Wage Burden in Dollars Laboratory Assessment Motor Assessment Temperament Assessment Accelerometer Training 110 1 1 0.75 0.50 0.75 82.5 55.0 82.5 $ 17 $ 17 $ 17 $ 1,402.50 $ 935.00 $ 1,402.50 Time Activity Diary 110 1 5.25 577.5 $ 17 $ 9,817.50 Follow up Home Visits 110 3 0.50 99.0 $ 17 $ 1,683.00 TOTAL 110  7.55 962.5  $ 16,362.50 6( b) Estimating Respondent Cost There are no direct costs to participants other than their time to participate in the study. 6( c) Estimating Agency Burden and Cost Burden Hours Cost ($) Agency Activities Contractor EPA Freq Total Hours Contractor $ 90/ hour EPA $ 95/ hour Administer labbased Evaluations 220 50 1 270 19,800 4,750 Instruct Parents on Accelerometer Use 110 0 1 110 9,900 0 Collect In home Data 110 0 3 330 29,700 0 Data Handling 220 0 1 220 19,800 0 Statistical Analysis 120 40 1 160 10,800 3,800 TOTAL 1,090 $ 90,000 $ 8,550 AGENCY TOTAL ANNUAL BURDEN: 1,090 hours AGENCY TOTAL ANNUAL COST: $ 98,550 These Agency burden estimates are based on our prior experience in developing and gathering information for research purposes. The Agency costs are based on a GS15 ( 8) for the Principal Investigator and include benefits. The contractor costs are based on a composite cost of projected study personnel. Estimated annualized hours and costs could be over estimated by 20% 6( d) Estimating the Respondent Universe and Total Burden and Costs The respondent universe is the 110 parent child dyads which will be enrolled in this study. The total estimated respondent burden and costs are 962.5 hours and $ 16,362 6( e) Bottom Line Burden and Costs The estimated respondent burden for this study is 962.5 hours and $ 16,362. The estimated Agency cost for conducting the study is 1,090 hours and $ 98,550. 6( f) Reasons for Change in Burden Not applicable   this is a new request. 6( g) Burden Statement 6 The annual public reporting and recordkeeping burden for this collection of information is estimated to average 8 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 currently valid OMB control number. The OMB control numbers for EPA's regulations are listed in 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 No. ORD 2004 0016, which is available for public viewing at the Office of Research and Development ( ORD) Docket in the EPA Docket Center ( EPA/ DC), EPA West, Room B102, 1301 Constitution Ave., NW, 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 Office of Research and Development Docket is ( 202) 566 1752. An electronic version of the public docket is available through EPA Dockets ( EDOCKET) at http:// www. epa. gov/ edocket. Use EDOCKET to submit or view public comments, access the index listing of the contents of the public docket, and to access those documents in the public docket that are available electronically. Once in the system, select " search," then key in the docket ID number identified above. Also, you can send comments to the Office of Information and Regulatory Affairs, Office of Management and Budget, 725 17th Street, NW, Washington, DC 20503, Attention: Desk Office for EPA. Please include the EPA Docket ID No. ( ORD 2004 0016) in any correspondence.

B. COLLECTIONS OF INFORMATION EMPLOYING STATISTICAL METHODS 1. Survey Objectives, Key Variables and other Preliminaries 1( a) Survey Objectives This project is a pilot study to determine feasibility and reliability of collected data. Data collection procedures were determined based on a thorough literature review of similar studies. 1( b) Key Variables This study will classify young children into two age groups: 6 12 months and 18 24 months. Because some studies have noted a difference in activity levels between boys and girls at older ages ( Jackson et al., 2003), the study will involve approximately equal numbers of boys and girls. 1( c) Statistical Approach To determine the number of subjects to be included in the study, we calculated the number of subjects that would be necessary to estimate mean movements per minute for a range of confidence interval widths. If the population mean is 215 movements per minute while awake and the population standard deviation is 15, a sample size of 22 subjects is needed to estimate the mean to within 7.5 movements per minute ( one half of a standard deviation) ( Table 1). This corresponds to being able to 7 detect a difference of 15 movements per minute in the value of two means ( the mean number of movements per minute for boys and the mean number of movements per minute for girls, for example) with a power of 89%. Comparable results are obtained if sample size estimates are based on movements per minute while sleeping. These standard deviation estimates are consistent with statistics reported in the literature.

Table 1. Determining Number of Subjects Movements per Minute While Awake Movements per Minutes While Asleep Number of Subjects Mean = 215 ( SD = 15) Mean = 21 ( SD = 5)

Distance from mean to limit 10 7.5 5 3 2.5 2 Number of children 14 22 44 17 22 32 * Based on a 2 sided confidence interval with confidence level 95%.

Attrition must be considered when determining the number of subjects required. Subjects may become ill or decide to discontinue participation during data collection. Some subjects may produce unusable data because of extreme ( and irresolvable) discrepancies between the activity diary and accelerometer. Anticipating attrition of 10% means that a total of 110 dyads will be recruited ( resulting in 100 parentchild dyads). The 110 will be divided into the four age groups of interest. 2. Survey Design 2( a) Target Population The target population for this study is infants and toddlers age 6   24 months residing in the Research Triangle Park, NC vicinity. 2 ( b) Sample Design Because data collected for this study will not be used to make estimates representative of children ages 6 to 24 months, but will instead be used to determine the most effective and efficient procedure for collecting spontaneous motor activity data, this study will not utilize random sampling procedures. A convenience sample will be drawn. Participants will be recruited in two ways: 1) parents and children will be recruited from child care/ day care settings by having day care staff distribute a letter to parents of children 4 months and older, and 2) community flyers will provide information about the study and invite interested adults to call a toll free number. To maximize response rates, the information collection will 1) recruit as participants only those who express interest in the study, 2) compensate participants for travel costs and time and 3) ask simplified items in the checklist participants will complete as their diaries, thus decreasing prospects of noncompliance. 4. Pretests and Pilot Studies This project is a pilot study to determine feasibility and reliability of collected data. Data collection procedures were determined based on a thorough literature review of similar studies. 8 Attachment 1 OMB Control No. 2080 XXXX Approval expires XX/ XX/ XX The public reporting and recordkeeping burden for this collection of information is estimated to average 8 hours per response. Send comments on the Agency's need for this information, the accuracy of the provided burden estimates, and any suggested methods for minimizing respondent burden, including through the use of automated collection techniques to the Director, Collection Strategies Division, U. S. Environmental Protection Agency ( 2822T), 1200 Pennsylvania Ave., NW, Washington, D. C. 20460. Include the OMB control number in any correspondence. Do not send the completed form to this address.

TIME ACTIVITY DIARY AND QUESTIONNAIRE APPLICATION OF MEASURES OF SPONTANEOUS MOTOR ACTIVITY FOR BEHAVIORAL ASSESSMENT IN HUMAN INFANTS CHILD ID NUMBER:

BIRTHDAY: Month Day Year AGE: Months WEIGHT: Pounds Ounces HEIGHT: Feet Inches TODAY'S DATE: Month Day Year EPA Form # 5310 8 9 TIME ACTIVITY DIARY AND QUESTIONNAIRE During the day, please record the time your child participates in the activities listed below. In order to provide the most accurate information, when you can please record the activities as they happen instead of waiting until the end of the day and recording information based on memory.

There is one activity chart for each day of the study. Each day, please enter the date, day of the week, activity code for each activity, the time the activity started and ended, and any comments about the activity you think are important. If you are unsure of how to code the activity, please write the activity in the comments box and we will code it for you. Please record all activities for a 24 hour period. The time activity diaries begin on the next page. The following is an example of a time activity diary for a 5 month old boy.

Example:

Date Day of Week Activity Code Time Started Time Ended Comments 01 6 : 30 A. M. P. M. 6: 45 A. M. P. M. 05 6 : 45 A. M. P. M. 7: 30 A. M. P. M. 06 7 : 30 A. M. P. M. 8: 30 A. M. P. M. 02 8 : 30 A. M. P. M. 9: 45 A. M. P. M. 01 9 : 45 A. M. P. M. 10: 00 A. M. P. M. 07 10: 00 A. M. P. M. 11: 00 A. M. P. M. 03 11: 00 A. M. P. M. 11: 15 A. M. P. M. 02 11: 15 A. M. P. M. 12: 30 A. M. P. M. 01 12: 30 A. M. P. M. 1: 00 A. M. P. M. 06 1 : 00 A. M. P. M. 2: 30 A. M. P. M. 02 2 : 30 A. M. P. M. 4: 00 A. M. P. M. 01 4 : 00 A. M. P. M. 4: 30 A. M. P. M. 09 4 : 30 A. M. P. M. 4: 45 A. M. P. M. 10 4 : 45 A. M. P. M. 5 : 30 A. M. P. M. Grocery store 09 5 : 30 A. M. P. M. 5: 45 A. M. P. M. 07 5 : 45 A. M. P. M. 6: 30 A. M. P. M. 03 6 : 30 A. M. P. M. 6: 45 A. M. P. M. 07 6 : 45 A. M. P. M. 7: 30 A. M. P. M. 04 7 : 30 A. M. P. M. 8: 00 A. M. P. M. 01 8 : 00 A. M. P. M. 8: 30 A. M. P. M. _ 06__/_ 28_/_ 2004_ Month Day Year Monday Tuesday Wednesday Thursday Friday Saturday Sunday 02 8 : 30__ A. M. P. M. 12: 01_ A. M. P. M. Bed time Code: Activity: Examples: Code: Activity: Examples: 01 Meals Breakfast, lunch, dinner, snacks, bottle feedings 07 Interactive Play Playing with another persons, such as a sibling or parent 02 Sleeping Night time and nap time 08 Watching TV/ Video Watching television, including videos or DVDs 03 Crying Any crying, including tantrums 09 Travel Time Riding in a car, bus, or other type of transportation 04 Bath Time Bathing 10 Shopping Going to a grocery or department store 05 Quiet Alert Child is not interacting with toys, but is observing surroundings 11 Preschool/ Daycare Attending a daycare or preschool 06 Solitary Play Sitting in an excersaucer, swing, bouncy seat, or on a blanket and entertaining them selves 12 Outdoor Play Playing on a swing set, swimming, running outside, and other activities that cannot take place indoors You will also be required to complete daily questions regarding your child's activities, general health, and routine. The daily questions begin on page 10. On the last day of the study, please complete the questions on page 11. 10 Day 1 ( First day of the study)

Date Day of Week Activity Code Time Started Time Ended Comments ____:___ A. M. P. M. ____:___ A. M. P. M.

____:___ A. M. P. M. ____:___ A. M. P. M.

____:___ A. M. P. M. ____:___ A. M. P. M.

____:___ A. M. P. M. ____:___ A. M. P. M.

____:___ A. M. P. M. ____:___ A. M. P. M.

____:___ A. M. P. M. ____:___ A. M. P. M.

____:___ A. M. P. M. ____:___ A. M. P. M.

____:___ A. M. P. M. ____:___ A. M. P. M.

____:___ A. M. P. M. ____:___ A. M. P. M.

____:___ A. M. P. M. ____:___ A. M. P. M.

____:___ A. M. P. M. ____:___ A. M. P. M.

____:___ A. M. P. M. ____:___ A. M. P. M.

____:___ A. M. P. M. ____:___ A. M. P. M.

____:___ A. M. P. M. ____:___ A. M. P. M.

____:___ A. M. P. M. ____:___ A. M. P. M.

____:___ A. M. P. M. ____:___ A. M. P. M.

____:___ A. M. P. M. ____:___ A. M. P. M.

____:___ A. M. P. M. ____:___ A. M. P. M.

____:___ A. M. P. M. ____:___ A. M. P. M.

____:___ A. M. P. M. ____:___ A. M. P. M.

______/_____/_____

Month Day Year Monday Tuesday Wednesday Thursday Friday Saturday Sunday ____:___ A. M. P. M. ____:___ A. M. P. M.

Activity Codes Code: Activity: Examples: Code: Activity: Examples:

01 Meals Breakfast, lunch, dinner, snacks,

bottle feedings 07 Interactive Play Playing with another persons, such as a sibling or parent 02 Sleeping Night time and nap time 08 Watching TV/ Video Watching television, including videos or DVDs 03 Crying Any crying, including tantrums 09 Travel Time Riding in a car, bus, or other type of transportation 04 Bath Time Bathing 10 Shopping Going to a grocery or department store 05 Quiet Alert Child is not interacting with toys,

but is observing surroundings 11 Preschool/ Daycare Attending a daycare or preschool 06 Solitary Play Sitting in an excersaucer, swing,

bouncy seat, or on a blanket and entertaining them selves 12 Outdoor Play Playing on a swing set, swimming, running outside, and other activities that cannot take place indoors 11 Day 2 Date Day of Week Activity Code Time Started Time Ended Comments ____:___ A. M. P. M. ____:___ A. M. P. M.

____:___ A. M. P. M. ____:___ A. M. P. M.

____:___ A. M. P. M. ____:___ A. M. P. M.

____:___ A. M. P. M. ____:___ A. M. P. M.

____:___ A. M. P. M. ____:___ A. M. P. M.

____:___ A. M. P. M. ____:___ A. M. P. M.

____:___ A. M. P. M. ____:___ A. M. P. M.

____:___ A. M. P. M. ____:___ A. M. P. M.

____:___ A. M. P. M. ____:___ A. M. P. M.

____:___ A. M. P. M. ____:___ A. M. P. M.

____:___ A. M. P. M. ____:___ A. M. P. M.

____:___ A. M. P. M. ____:___ A. M. P. M.

____:___ A. M. P. M. ____:___ A. M. P. M.

____:___ A. M. P. M. ____:___ A. M. P. M.

____:___ A. M. P. M. ____:___ A. M. P. M.

____:___ A. M. P. M. ____:___ A. M. P. M.

____:___ A. M. P. M. ____:___ A. M. P. M.

____:___ A. M. P. M. ____:___ A. M. P. M.

____:___ A. M. P. M. ____:___ A. M. P. M.

____:___ A. M. P. M. ____:___ A. M. P. M.

______/_____/_____

Month Day Year Monday Tuesday Wednesday Thursday Friday Saturday Sunday ____:___ A. M. P. M. ____:___ A. M. P. M.

Activity Codes Code: Activity: Examples: Code: Activity: Examples:

01 Meals Breakfast, lunch, dinner, snacks,

bottle feedings 07 Interactive Play Playing with another persons, such as a sibling or parent 02 Sleeping Night time and nap time 08 Watching TV/ Video Watching television, including videos or DVDs 03 Crying Any crying, including tantrums 09 Travel Time Riding in a car, bus, or other type of transportation 04 Bath Time Bathing 10 Shopping Going to a grocery or department store 05 Quiet Alert Child is not interacting with toys,

but is observing surroundings 11 Preschool/ Daycare Attending a daycare or preschool 06 Solitary Play Sitting in an excersaucer, swing,

bouncy seat, or on a blanket and entertaining them selves 12 Outdoor Play Playing on a swing set, swimming, running outside, and other activities that cannot take place indoors 12 Day 3 Date Day of Week Activity Code Time Started Time Ended Comments ____:___ A. M. P. M. ____:___ A. M. P. M.

____:___ A. M. P. M. ____:___ A. M. P. M.

____:___ A. M. P. M. ____:___ A. M. P. M.

____:___ A. M. P. M. ____:___ A. M. P. M.

____:___ A. M. P. M. ____:___ A. M. P. M.

____:___ A. M. P. M. ____:___ A. M. P. M.

____:___ A. M. P. M. ____:___ A. M. P. M.

____:___ A. M. P. M. ____:___ A. M. P. M.

____:___ A. M. P. M. ____:___ A. M. P. M.

____:___ A. M. P. M. ____:___ A. M. P. M.

____:___ A. M. P. M. ____:___ A. M. P. M.

____:___ A. M. P. M. ____:___ A. M. P. M.

____:___ A. M. P. M. ____:___ A. M. P. M.

____:___ A. M. P. M. ____:___ A. M. P. M.

____:___ A. M. P. M. ____:___ A. M. P. M.

____:___ A. M. P. M. ____:___ A. M. P. M.

____:___ A. M. P. M. ____:___ A. M. P. M.

____:___ A. M. P. M. ____:___ A. M. P. M.

____:___ A. M. P. M. ____:___ A. M. P. M.

____:___ A. M. P. M. ____:___ A. M. P. M.

______/_____/_____

Month Day Year Monday Tuesday Wednesday Thursday Friday Saturday Sunday ____:___ A. M. P. M. ____:___ A. M. P. M.

Activity Codes Code: Activity: Examples: Code: Activity: Examples:

01 Meals Breakfast, lunch, dinner, snacks,

bottle feedings 07 Interactive Play Playing with another persons, such as a sibling or parent 02 Sleeping Night time and nap time 08 Watching TV/ Video Watching television, including videos or DVDs 03 Crying Any crying, including tantrums 09 Travel Time Riding in a car, bus, or other type of transportation 04 Bath Time Bathing 10 Shopping Going to a grocery or department store 05 Quiet Alert Child is not interacting with toys,

but is observing surroundings 11 Preschool/ Daycare Attending a daycare or preschool 06 Solitary Play Sitting in an excersaucer, swing,

bouncy seat, or on a blanket and entertaining them selves 12 Outdoor Play Playing on a swing set, swimming, running outside, and other activities that cannot take place indoors 13 Day 4 Date Day of Week Activity Code Time Started Time Ended Comments ____:___ A. M. P. M. ____:___ A. M. P. M.

____:___ A. M. P. M. ____:___ A. M. P. M.

____:___ A. M. P. M. ____:___ A. M. P. M.

____:___ A. M. P. M. ____:___ A. M. P. M.

____:___ A. M. P. M. ____:___ A. M. P. M.

____:___ A. M. P. M. ____:___ A. M. P. M.

____:___ A. M. P. M. ____:___ A. M. P. M.

____:___ A. M. P. M. ____:___ A. M. P. M.

____:___ A. M. P. M. ____:___ A. M. P. M.

____:___ A. M. P. M. ____:___ A. M. P. M.

____:___ A. M. P. M. ____:___ A. M. P. M.

____:___ A. M. P. M. ____:___ A. M. P. M.

____:___ A. M. P. M. ____:___ A. M. P. M.

____:___ A. M. P. M. ____:___ A. M. P. M.

____:___ A. M. P. M. ____:___ A. M. P. M.

____:___ A. M. P. M. ____:___ A. M. P. M.

____:___ A. M. P. M. ____:___ A. M. P. M.

____:___ A. M. P. M. ____:___ A. M. P. M.

____:___ A. M. P. M. ____:___ A. M. P. M.

____:___ A. M. P. M. ____:___ A. M. P. M.

______/_____/_____

Month Day Year Monday Tuesday Wednesday Thursday Friday Saturday Sunday ____:___ A. M. P. M. ____:___ A. M. P. M.

Activity Codes Code: Activity: Examples: Code: Activity: Examples:

01 Meals Breakfast, lunch, dinner, snacks,

bottle feedings 07 Interactive Play Playing with another persons, such as a sibling or parent 02 Sleeping Night time and nap time 08 Watching TV/ Video Watching television, including videos or DVDs 03 Crying Any crying, including tantrums 09 Travel Time Riding in a car, bus, or other type of transportation 04 Bath Time Bathing 10 Shopping Going to a grocery or department store 05 Quiet Alert Child is not interacting with toys,

but is observing surroundings 11 Preschool/ Daycare Attending a daycare or preschool 06 Solitary Play Sitting in an excersaucer, swing,

bouncy seat, or on a blanket and entertaining them selves 12 Outdoor Play Playing on a swing set, swimming, running outside, and other activities that cannot take place indoors 14 Day 5 Date Day of Week Activity Code Time Started Time Ended Comments ____:___ A. M. P. M. ____:___ A. M. P. M.

____:___ A. M. P. M. ____:___ A. M. P. M.

____:___ A. M. P. M. ____:___ A. M. P. M.

____:___ A. M. P. M. ____:___ A. M. P. M.

____:___ A. M. P. M. ____:___ A. M. P. M.

____:___ A. M. P. M. ____:___ A. M. P. M.

____:___ A. M. P. M. ____:___ A. M. P. M.

____:___ A. M. P. M. ____:___ A. M. P. M.

____:___ A. M. P. M. ____:___ A. M. P. M.

____:___ A. M. P. M. ____:___ A. M. P. M.

____:___ A. M. P. M. ____:___ A. M. P. M.

____:___ A. M. P. M. ____:___ A. M. P. M.

____:___ A. M. P. M. ____:___ A. M. P. M.

____:___ A. M. P. M. ____:___ A. M. P. M.

____:___ A. M. P. M. ____:___ A. M. P. M.

____:___ A. M. P. M. ____:___ A. M. P. M.

____:___ A. M. P. M. ____:___ A. M. P. M.

____:___ A. M. P. M. ____:___ A. M. P. M.

____:___ A. M. P. M. ____:___ A. M. P. M.

____:___ A. M. P. M. ____:___ A. M. P. M.

______/_____/_____

Month Day Year Monday Tuesday Wednesday Thursday Friday Saturday Sunday ____:___ A. M. P. M. ____:___ A. M. P. M.

Activity Codes Code: Activity: Examples: Code: Activity: Examples:

01 Meals Breakfast, lunch, dinner, snacks,

bottle feedings 07 Interactive Play Playing with another persons, such as a sibling or parent 02 Sleeping Night time and nap time 08 Watching TV/ Video Watching television, including videos or DVDs 03 Crying Any crying, including tantrums 09 Travel Time Riding in a car, bus, or other type of transportation 04 Bath Time Bathing 10 Shopping Going to a grocery or department store 05 Quiet Alert Child is not interacting with toys,

but is observing surroundings 11 Preschool/ Daycare Attending a daycare or preschool 06 Solitary Play Sitting in an excersaucer, swing,

bouncy seat, or on a blanket and entertaining them selves 12 Outdoor Play Playing on a swing set, swimming, running outside, and other activities that cannot take place indoors 15 Day 6 Date Day of Week Activity Code Time Started Time Ended Comments ____:___ A. M. P. M. ____:___ A. M. P. M.

____:___ A. M. P. M. ____:___ A. M. P. M.

____:___ A. M. P. M. ____:___ A. M. P. M.

____:___ A. M. P. M. ____:___ A. M. P. M.

____:___ A. M. P. M. ____:___ A. M. P. M.

____:___ A. M. P. M. ____:___ A. M. P. M.

____:___ A. M. P. M. ____:___ A. M. P. M.

____:___ A. M. P. M. ____:___ A. M. P. M.

____:___ A. M. P. M. ____:___ A. M. P. M.

____:___ A. M. P. M. ____:___ A. M. P. M.

____:___ A. M. P. M. ____:___ A. M. P. M.

____:___ A. M. P. M. ____:___ A. M. P. M.

____:___ A. M. P. M. ____:___ A. M. P. M.

____:___ A. M. P. M. ____:___ A. M. P. M.

____:___ A. M. P. M. ____:___ A. M. P. M.

____:___ A. M. P. M. ____:___ A. M. P. M.

____:___ A. M. P. M. ____:___ A. M. P. M.

____:___ A. M. P. M. ____:___ A. M. P. M.

____:___ A. M. P. M. ____:___ A. M. P. M.

____:___ A. M. P. M. ____:___ A. M. P. M.

______/_____/_____

Month Day Year Monday Tuesday Wednesday Thursday Friday Saturday Sunday ____:___ A. M. P. M. ____:___ A. M. P. M.

Activity Codes Code: Activity: Examples: Code: Activity: Examples:

01 Meals Breakfast, lunch, dinner, snacks,

bottle feedings 07 Interactive Play Playing with another persons, such as a sibling or parent 02 Sleeping Night time and nap time 08 Watching TV/ Video Watching television, including videos or DVDs 03 Crying Any crying, including tantrums 09 Travel Time Riding in a car, bus, or other type of transportation 04 Bath Time Bathing 10 Shopping Going to a grocery or department store 05 Quiet Alert Child is not interacting with toys,

but is observing surroundings 11 Preschool/ Daycare Attending a daycare or preschool 06 Solitary Play Sitting in an excersaucer, swing,

bouncy seat, or on a blanket and entertaining them selves 12 Outdoor Play Playing on a swing set, swimming, running outside, and other activities that cannot take place indoors 16 Day 7 ( Last day of the study)

Date Day of Week Activity Code Time Started Time Ended Comments ____:___ A. M. P. M. ____:___ A. M. P. M.

____:___ A. M. P. M. ____:___ A. M. P. M.

____:___ A. M. P. M. ____:___ A. M. P. M.

____:___ A. M. P. M. ____:___ A. M. P. M.

____:___ A. M. P. M. ____:___ A. M. P. M.

____:___ A. M. P. M. ____:___ A. M. P. M.

____:___ A. M. P. M. ____:___ A. M. P. M.

____:___ A. M. P. M. ____:___ A. M. P. M.

____:___ A. M. P. M. ____:___ A. M. P. M.

____:___ A. M. P. M. ____:___ A. M. P. M.

____:___ A. M. P. M. ____:___ A. M. P. M.

____:___ A. M. P. M. ____:___ A. M. P. M.

____:___ A. M. P. M. ____:___ A. M. P. M.

____:___ A. M. P. M. ____:___ A. M. P. M.

____:___ A. M. P. M. ____:___ A. M. P. M.

____:___ A. M. P. M. ____:___ A. M. P. M.

____:___ A. M. P. M. ____:___ A. M. P. M.

____:___ A. M. P. M. ____:___ A. M. P. M.

____:___ A. M. P. M. ____:___ A. M. P. M.

____:___ A. M. P. M. ____:___ A. M. P. M.

______/_____/_____

Month Day Year Monday Tuesday Wednesday Thursday Friday Saturday Sunday ____:___ A. M. P. M. ____:___ A. M. P. M.

Activity Codes Code: Activity: Examples: Code: Activity: Examples:

01 Meals Breakfast, lunch, dinner, snacks,

bottle feedings 07 Interactive Play Playing with another persons, such as a sibling or parent 02 Sleeping Night time and nap time 08 Watching TV/ Video Watching television, including videos or DVDs 03 Crying Any crying, including tantrums 09 Travel Time Riding in a car, bus, or other type of transportation 04 Bath Time Bathing 10 Shopping Going to a grocery or department store 05 Quiet Alert Child is not interacting with toys,

but is observing surroundings 11 Preschool/ Daycare Attending a daycare or preschool 06 Solitary Play Sitting in an excersaucer, swing,

bouncy seat, or on a blanket and entertaining them selves 12 Outdoor Play Playing on a swing set, swimming, running outside, and other activities that cannot take place indoors 17 Daily Questions Question Day 1 Day 2 Day 3 Day 4 Day 5 Day 6 Day 7 Date: Date: Date: Date: Date: Date: Date:

Was the child's ( the child participating in this study) routine or activities today normal for a typical day? Yes No Yes No Yes No Yes No Yes No Yes No Yes No Did the child take any prescription or over the counter medicines today? If so, what?

___________________________ ___________________________ Yes No Yes No Yes No Yes No Yes No Yes No Yes No Was the child sick or ill today? Yes No Yes No Yes No Yes No Yes No Yes No Yes No Was the actigraphy monitor removed or did it accidentally fall off today at any time? Yes No If yes, what time did this occur: __________ Yes No If yes, what time did this occur: __________ Yes No If yes, what time did this occur: __________ Yes No If yes, what time did this occur: __________ Yes No If yes, what time did this occur: __________ Yes No If yes, what time did this occur: __________ Yes No If yes, what time did this occur: __________

Approximately how much time did the child spend with his or her mother or primary female caregiver today? < 1 hour 1 2 hours 3 4 hours 5 6 hours 7 8 hours > 8 hours < 1 hour 1 2 hours 3 4 hours 5 6 hours 7 8 hours > 8 hours < 1 hour 1 2 hours 3 4 hours 5 6 hours 7 8 hours > 8 hours < 1 hour 1 2 hours 3 4 hours 5 6 hours 7 8 hours > 8 hours < 1 hour 1 2 hours 3 4 hours 5 6 hours 7 8 hours > 8 hours < 1 hour 1 2 hours 3 4 hours 5 6 hours 7 8 hours > 8 hours < 1 hour 1 2 hours 3 4 hours 5 6 hours 7 8 hours > 8 hours Approximately how much time did the child spend with his or her father or primary male caregiver today? < 1 hour 1 2 hours 3 4 hours 5 6 hours 7 8 hours > 8 hours < 1 hour 1 2 hours 3 4 hours 5 6 hours 7 8 hours > 8 hours < 1 hour 1 2 hours 3 4 hours 5 6 hours 7 8 hours > 8 hours < 1 hour 1 2 hours 3 4 hours 5 6 hours 7 8 hours > 8 hours < 1 hour 1 2 hours 3 4 hours 5 6 hours 7 8 hours > 8 hours < 1 hour 1 2 hours 3 4 hours 5 6 hours 7 8 hours > 8 hours < 1 hour 1 2 hours 3 4 hours 5 6 hours 7 8 hours > 8 hours 18 Additional Questions to be Completed on the Last Day of the Study Question Responses Mark all that apply.

Has a doctor or health professional ever told you that the child had attention deficit disorder,

mental retardation, or any other development delay? No Attention deficit disorder Mental retardation Other developmental delay Please specify: ___________________________

Does the child have any impairment or health problem that limits his or her movement or ability to crawl, walk, run, or play? No Yes Was the child born prematurely? No Yes: If yes: What week of gestation was the child born?

_______________________

How many brothers or sisters does the child have? 0 1 2 3 or more Where do you live? In a city In a suburb In the country ( rural area)

On a farm What is the highest level of school the child's mother has completed? Less than high school High school diploma Technical or trade school Some college, no degree 2 or 4 year degree Graduate degree What is the highest level of school the child's father has completed? Less than high school High school diploma Technical or trade school Some college 2 or 4 year degree Graduate degree 19 Attachment 2 Description and Domains of ITSEA, IBQ and PDMS 2 ITSEA and IBQ Personality characteristics such as temperament affect a person's movement or activity level. Researchers have noted that one of the consistent dimensions of temperament across time is that of activity level ( Thomas & Chess, 1977). The ITSEA is suitable for use in 6 12 month old infants. The following chart summarizes the domains of temperament and sample question items the ITSEA uses to measure these domains.

ITSEA Behavior Domain/ Scales Sample Items from ITSEA Externalizing Scales Activity/ Impulsivity Is restless and can't sit still Aggression/ Defiance Has temper tantrums Peer Aggression Hits, shoves, kicks, or bites other children Internalizing Scales Depression/ Withdrawal Looks unhappy or sad without any reason General Anxiety Worries a lot or is very serious Separation Distress Hangs on you or wants to be in your lap when with other people Inhibition to Novelty Is quiet or less active in new situations Dysregulation Scales Sleep Must be held to go to sleep Negative Emotionality Has trouble calming down when upset Eating Refuses to eat foods that require chewing Sensory Sensitivity Won't touch some objects because of how they feel Competence Scales Compliance Tries to do as you ask Attention Sits for 5 minutes while you read a story Imitation/ Pretend Play Hugs or feeds dolls or stuffed animals Mastery Motivation Enjoys challenging activities Empathy Is worried or upset when someone is hurt Prosocial Peer Relations Takes turns when playing with others 20 Attachment 2 ( continued)

IBQ The IBQ is applicable for assessment of temperament in the 18 24 month old infants. It includes a total of 94 items on six scales; Activity Level, Smiling and Laughter, Fear, Soothability, Distress to Limitations, Duration to Orienting. There are seven response options, ranging from " never" to " always" as well as a " does not apply" option.

PDMS 1 Gross and fine motor development follows a consistent trajectory throughout development. The PDMS 2 measures this development in six specific domains. These domains are listed in the chart below with a more complete description of each domain.

PDMS 2 Scale Domains Description of Measure Gross Motor Reflexes Child's ability to automatically react to environmental events.

Gross Motor Stationary Child's ability to sustain control of his or her body within its center of gravity and retain equilibrium.

Gross Motor Locomotion Child's ability to move from one place to another by crawling, walking, running, hopping, and jumping forward.

Gross Motor Object manipulation Child's ability to manipulate balls by catching, throwing, and kicking ( because these skills are not apparent until a child has reached the age of 11 months, this subtest is only given to children ages 12 months and older).

Fine Motor Grasping Child's ability to use his or her hands. It begins with the ability to hold an object with one hand and progresses to actions involving the controlled use of the fingers of both hands.

Fine Motor Visual motor integration Child's ability to use his or her visual perceptual skills to perform complex eye hand coordination tasks such as reaching and grasping for an object, building with blocks, and copying designs.


"King, Heidi R."<EMAIL_ADDRESS> 09/29/2008 05:25 PM

To

Ron Evans/RTP/USEPA/US@EPA

cc

Brian Heninger/DC/USEPA/US@EPA, Charlotte Bertrand/DC/USEPA/US@EPA, Charles Fulcher/RTP/USEPA/US@EPA, Darryl Weatherhead/RTP/USEPA/US@EPA, Kathy Kaufman/RTP/USEPA/US@EPA, "Clark, Michael C." <EMAIL_ADDRESS>Nathalie Simon/DC/USEPA/US@EPA, Al McGartland/DC/USEPA/US@EPA, Neal Fann/RTP/USEPA/US@EPA, Tricia Crabtree/RTP/USEPA/US@EPA, Lydia Wegman/RTP/USEPA/US@EPA, Rosalina Rodriguez/RTP/USEPA/US@EPA, Tom Walton/RTP/USEPA/US@EPA, "Fraas, Arthur G."<EMAIL_ADDRESS>"Lee, Amanda I." <EMAIL_ADDRESS>"Mancini, Dominic J." <EMAIL_ADDRESS> Subject

RE: counties not in attainment for Pb NAAQS RIA

Thanks --

h

-----Original Message-----

From<EMAIL_ADDRESS><EMAIL_ADDRESS> Sent: Monday, September 29, 2008 5:26 PM

To: King, Heidi R.

Cc<EMAIL_ADDRESS><EMAIL_ADDRESS> <EMAIL_ADDRESS><EMAIL_ADDRESS> <EMAIL_ADDRESS>Clark, Michael C.;

<EMAIL_ADDRESS><EMAIL_ADDRESS> <EMAIL_ADDRESS><EMAIL_ADDRESS> <EMAIL_ADDRESS><EMAIL_ADDRESS> <EMAIL_ADDRESS>Fraas, Arthur G.; Lee, Amanda I.; Mancini, Dominic

J.

Subject: counties not in attainment for Pb NAAQS RIA

Heidi, this morning Kathy offered to share information about what we

know about the sources in the 9 counties which do not attain a 0.15

microgram/m3 standard with identified controls.  The data is shown in

the attached.  In summary:

o     Every county has a metal processing facility, these are largely

small facilities.   Some of which have existing controls (like a

baghouse).  Others do not have control information in the NEI.

o     4 of the counties have known land contamination, 3 of which have

Superfund sites.

We will be happy to discuss these once you have had a chance to review

the enclosed.  Have a good evening.

Ron

(See attached file: Pb sources at monitors over 0.15 ron.doc)