83 I SUPPORTING STATEMENT ENVIRONMENTAL PROTECTION AGENCY National Emission Standards for Hazardous Air Pollutants for Source Categories: Generic Maximum Achievable Control Technology ( 40 CFR Part 63, Subpart YY)

1. Identification of the Information Collection 1( a) Title of the Information Collection The title of this Information Collection Request ( ICR) is National Emission Standards for Hazardous Air Pollutants for Source Categories: Generic Maximum Achievable Control Technology ( 40 CFR Part 63, Subpart YY). This title differs slightly from the title of the currently approved ICR, National Emission Standards for Hazardous Air Pollutants: Generic Maximum Achievable Control Technology. The title of the ICR was changed to more closely resemble the title of the standard.

1( b) Short Characterization/ Abstract The National Emission Standards for Hazardous Air Pollutants ( NESHAP) for Source Categories: Generic Maximum Achievable Control Technology ( hereafter, this subpart is referred to as the " Generic MACT") were proposed on October 14, 1998 at 63 FR 55178 and promulgated on June 29, 1999 at 64 FR 34854. These regulations apply to hazardous air pollutant ( HAP) emission sources in four categories including: Polycarbonates ( PC) Production, Acrylic and Modacrylic Fibers ( AMF) Production, Acetal Resins ( AR) Production and Hydrogen Fluoride ( HF) Production. This Information Collection Request ( ICR) addresses these four source categories. On December 6, 2000 at 63 FR 76408, the Agency added four additional source categories to the Generic MACT rule including: Cyanide Chemicals Manufacturing, Carbon Black Production, Ethylene Production, and Spandex Production, which are being addressed by ICR Number 1983.02. An OMB Control Number has not been assigned yet to this other ICR. On November 2, 2001, the Agency promulgated wastewater provisions amendments to the Generic MACT applicable to wastewater streams for the AR, AMF, and PC production source categories. The HF production source category does not have wastewater streams. On June 7, 2002, the Agency made additional amendments as a direct ruling to the Generic MACT to clarify definitions and the recordkeeping provisions related to how readily accessible records should be maintained. This information is being collected to assure compliance with the provisions of 40 CFR Part 63, Subpart YY.

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 startup, shutdown, or malfunction in the operation of an affected facility, or any 2 period during which the monitoring system is inoperative. The specific monitoring and recordkeeping requirements vary for each source category depending on the types of emissions control equipment and monitoring equipment used to comply with the Generic MACT standards for their category. 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 all records, including reports and notifications for at least five years. This is consistent with the General Provisions as applied to the standards. EPA believes that the five year records retention requirement is consistent with the Part 70 permit program and the five year statute of limitations on which the permit program is based. 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. All reports are sent to the delegated State or local authority. In the event that there is no such delegated authority, the reports are sent directly to the United States Environmental Protection Agency ( EPA) Regional Office.

There are a total of ten sources, within the four source categories listed above, currently subject to the Generic MACT rule, and it is estimated that no new sources per year will become subject to the regulation in the next three years. The total number of sources subject to the Generic MACT rule has decreased by one when compared with the active ICR due to one PC source closing its facility. The breakdown of number of sources per source category is: the AR production source category has two facilities, the AMF production source category has three facilities, the HF production source category has one facility, and the PC production source category has four facilities. This estimate is based on information gathered during the development of the rule and consultation with the Office of Air Quality, Planning and Standards ( OAQPS) rule lead for each source category and industry representatives within all four source categories.

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: 3 ( 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 a manner as the Administrator shall prescribe); ( E) keep records on control equipment parameters, production variables or other indirect data when direct monitoring of emissions is impractical; ( F) submit compliance certifications in accordance with Section 114( a)( 3); and ( G) provide such other information as the Administrator may reasonably require.

In the Administrator's judgment, hazardous air pollutant emissions from the AMF, AR, HF and PC source categories cause or contribute to air pollution that may reasonably be anticipated to endanger public health or welfare. Therefore, the NESHAP was promulgated for this source category at 40 CFR Part 63, Subpart YY.

2( b) Practical Utility/ Users of the Data The control of hazardous air pollutant ( HAP) emissions from the AMF, AR, HF and PC source categories require not only the installation of properly designed equipment, but also the operation and maintenance of that equipment. Emissions of HAPs ( including total organic HAP emissions and acrylonitrile emissions) from these sources are the result of the operation of the affected facilities. The Generic MACT standards are achieved by the capture and/ or reduction of HAP emissions from storage vessels, front end and back end process vents from continuous unit operations, equipment as defined in the rule, production process units that generate process, or maintenance wastewater, and fiber spinning lines, by using the applicable control technology specified in the rule including using a flare and/ or venting emissions through a closed vent system to any control device or combination of control devices meeting the requirements of Subparts SS or WW of Part 63, venting emissions through a closed vent system to a recovery system or wet scrubber, venting emissions through a closed vent system to a halogen reduction device meeting the requirements of Subpart SS, enclosing the spinning and washing areas, as well as, following the equipment leaks requirements under Subparts TT ( control level 1) and UU ( control level 2) of Part 63. The notifications required by this regulation 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, 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 periodic 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 Generic MACT standards continue to operate the control equipment and achieve compliance with 4 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 requested recordkeeping and reporting are required under 40 CFR Part 63, Subpart YY.

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 An announcement of a public comment period for the renewal of this ICR was published in the Federal Register on October 29, 2001. No comments were received on the burden published in the Federal Register.

3( c) Consultations The burden estimate for this Information Collection Request ( ICR), was determined in consultation with the rule leads for each source category for the Office of Air Quality, Planning and Standards ( OAQPS) and EPA Regional contacts, who provided updated information on the industry growth rate, the current number of facilities, the rule requirements and other rule related information. We also consulted industry representatives. Following is a list of contacts. 5 Organization Contact Information Type Phone Number OAQPS David W. Markwordt General rule related ( 919) 541 0837 OAQPS Richard Colyer HF source category ( 919) 541 5262 OAQPS Mark Morris PC source category ( 919) 541 5416 OAQPS John Schaefer AR source category ( 919) 541 0296 OAQPS Tony Wayne AMF source category ( 919) 541 5439 General Electric/ Industry Stephen Capone PC capital/ operation and maintenance costs ( 413) 448 7609 Dupont/ Industry John Dege HF capital/ operation and maintenance costs ( 302) 773 0900 Dupont/ Industry Robert Ritchey AR capital/ operation and maintenance costs ( 304) 863 4271 EPA Region IV Leonardo Ceron AMF affected facilities ( 404) 562 9129 Dow Chemical/ Industry Steve Knis PC capital/ operation and maintenance costs ( 979) 238 2011 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 1320.5. 6 3( f) Confidentiality The required information has been determined not to be confidential. 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 1, Part 2, Subpart B  Confidentiality of Business Information ( see 40 CFR 2; 41 FR 36902, September 1, 1976; amended by 43 FR 40000, September 8, 1978; 43 FR 42251, September 20, 1978; 44 FR 17674, March 23, 1979).

3( g) Sensitive Questions None of the reporting or recordkeeping requirements contain sensitive questions.

4. The Respondents and the Information Requested 4( a) Respondents/ SIC Codes The respondents to the recordkeeping and reporting requirements are sources of HAP emissions in four categories: Polycarbonates ( PC) Production, Acrylic and Modacrylic Fibers ( AMF) Production, Acetal Resins ( AR) Production and Hydrogen Fluoride ( HF) Production. The following table summarizes the SIC ( United States Standard Industrial Classification) codes and their corresponding NAICS ( The North American Industry Classification System) codes for each source category subject to 40 CFR Part 63, Subpart YY.

Source Category SIC Code ( Description) NAICS Code ( Description)

Hydrogen Fluoride Production 2819 ( Industrial Inorganic Chemicals, Not Elsewhere Classified) 325188 ( All Other Basic Inorganic Chemical Manufacturing)

Acetal Resins Production 2821 ( Plastics Materials, Synthetic Resins, and Nonvulcanizable Elastomers) 325211 ( Plastics Material and Resin Manufacturing)

Acrylic and Modacrylic Fiber Production 2824 ( Manmade Organic Fibers, Except Cellulosis) 325222 ( Noncellulosic Organic Fiber Manufacturing)

Polycarbonates Production 2822 ( Synthetic Rubber Vulcanizable Elastomers) 325212 ( Synthetic Rubber Manufacturing) 7 4( b) Information Requested ( i) Data Items All data in this ICR that is recorded and/ or reported is required by 40 CFR, PART 63, Subpart YY.

A source must make the following reports:

Reports for 40 CFR, Part 63, Subpart YY Approval for construction/ reconstruction 63.5( d), 63.1110( a)

Initial notification of startup 63.110( b)

Initial notification of applicability 63.9( b), 63.1110( a) 63.1110( c)

Compliance Status Report 63.9( h), 63.1110( a), 63.1110( d)

Notification of performance test and performance evaluation results 63.7( b), 63.9( e), 63.10( d)( 2), 63.1110( d), 63.1110( a)

Rescheduled initial performance test 63.7( b)( 2)

Demonstration of continuous monitoring system 63.9( g)

Physical or operational change 63( a)( 8)

Opacity or visible emissions 63.10( d)( 3)

Develop start up, shutdown, malfunction plan and periodic reports 63.10( d)( 5)( i), 63.1110( b), 63.1111 Excess emissions and continuous parameter monitoring systems ( CPMS) performance reports 63.1110( a) 8 Reports for 40 CFR, Part 63, Subpart YY Periodic reports ( semiannual or according to the schedule for Title V) with information on excess emissions and on the implementation of leak detection and repair ( LDAR) standard provisions 63.1110( e), 63.1018( a), 63.1039 Startup, Shutdown and Malfunction Reports 63.1110( a), 63.1111( b)

A source must maintain the following records:

Recordkeeping for 40 CFR, Part 63, Subpart YY Start ups, shutdowns, malfunctions, periods when excess emissions have occurred during the reporting period 63.10( b)( 2), 63.1109( a)

Records of performance test and performance evaluation results 63.1109( a)

All reports and notifications 63.10( b), 63.1109( a)

Record of applicability 63.10( b)( 3), 631109( d)

Records of initial and compliance status notifications 63.998( a), 631109( a)

Records of CPMS operation, adjustments, calibration checks, and maintenance 63.10( b)( 2)( vii), 631109( a)

Records of implementation of LDAR standards provisions 63.107 Records are required to be retained for five of years. The first two years of records must be retained at the facility. 63.10( b)( 2) 9 ( ii.) Respondent Activities Respondent Activities Read instructions.

Conduct control device performance tests.

Conduct a performance evaluation of the CPMS.

Inspect and monitor closed vent system.

Monitor control devices.

Write the notifications and reports listed above.

Enter information required to be recorded above.

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

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

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

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

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

Transmit, or otherwise disclose the information.

The information on sources of HAP emissions for the AMF, AR, HF and PC source categories is gathered by EPA and the States through inspections and reports submitted by industry. Presently, several regulatory agencies are setting up electronic reporting systems to enable facilities to report electronically, which will further reduce labor costs. 10 5. The Information Collected: Agency Activities, Collection Methodology, and Information Management 5( a) Agency Activities EPA conducts the following activities in connection with the acquisition, analysis, storage, and distribution of the required information.

Agency Activities Observe initial performance tests and repeat performance tests if necessary.

Review notifications and reports, including performance test reports, and periodic 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.

5( b) Collection Methodology and Management Following notification of startup, the reviewing authority might inspect the source to determine whether the pollution control devices are properly installed and operated. Performance test reports are used by the Agency to discern a source's initial capability to comply with the emission standard. Data and records maintained by the respondents are tabulated and published for use in compliance and enforcement programs. The periodic reports ( semiannual or according to the schedule for Title V reporting) are used for problem identification, as a check on source operation and maintenance, and for compliance determinations.

Information contained in the reports is entered into AFS which is operated and maintained by EPA's Office of Air Quality Planning and Standards. AFS is EPA's database for the collection, maintenance, and retrieval of compliance and annual emission inventory data for over 100,000 industrial and government owned facilities. EPA uses AFS for tracking air pollution compliance and enforcement by local and State regulatory agencies, EPA Regional Offices and EPA Headquarters. EPA and its delegated Authorities can edit, store, retrieve and analyze the data.

The records required by this regulation must be retained by the owner or operator for five 11 years.

5( c) Small Entity Flexibility There is a distribution of business sizes subject to this regulation. Minimizing the information collection burden for all sizes of businesses is a continuing effort on the EPA's part. Therefore, the EPA has reduced the recordkeeping and reporting requirement respondent burden to include only the information needed by the EPA to determine compliance with the Generic MACT standards. To the extent that larger businesses can use economies of scale to reduce their burden, the overall burden will be reduced.

5( d) Collection Schedule The specific frequency for each information collection activity required by the Generic MACT rule for each source category are shown in Tables 2a through 2d, Annual ( Source Category) Industry Burden and Cost: National Emission Standards for Hazardous Air Pollutants for Source Categories: Generic Maximum Achievable Control Technology ( 40 CFR Part 63, Subpart YY) standards. Specifically, the tables address each category as follows: Table 2a  Annual AMF Production Industry Burden and Cost, Table 2b  Annual AR Production Industry Burden and Cost, Table 2c  Annual HF Production Industry Burden and Cost, and Table 2d  Annual PC Production Industry Burden and Cost.

6. Estimating the Burden and Cost of the Collection Tables 2a through 2d document the computation of individual burdens for the recordkeeping and reporting requirements applicable to each of the four source categories addressed 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 in the tables. Responses to this information collection are mandatory.

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

6( a) Estimating Respondent Burden The average annual burden to industry over the next three years from these recordkeeping and reporting requirements is estimated to be 4,077 labor hours ( The sum of the " Total Labor Hours" from Tables 2a through Table 2d, as summarized below). These hours are based on Agency studies and background documents from the development of the regulation, the most 12 recently approved ICR and consultation with the OAQPS lead for each source category and industry representatives in each source category.

Table Number Major Source Category Total Labor Hours ( Rounded) Total Cost ( Rounded)

2a AMF 1,511 $ 85,459 2b AR 1,007 $ 56,973 2c HF 474 $ 26,783 2d PC 1,085 $ 69,377 Total Burden and Cost 4,077 $ 238,592 6( b) Estimating Respondent Costs ( i) Estimating Labor Costs This ICR uses the following labor rates: $ 85.81 per hour for Executive, Administrative, and Managerial labor; $ 57.12 per hour for Technical labor, and $ 36.27 per hour for Clerical labor. These rates are from the United States Department of Labor, Bureau of Labor Statistics, March 2001, " Table 10. Private industry, by occupational and industry group." The rates are from Column 1, " Total compensation." The wage rates have been increased by 110% to account for the benefit packages available to those employed by private industry.

Managerial $ 85.81 ($ 40.86 + 110%) Technical $ 57.12 ($ 27.20 + 110%) Clerical $ 36.27 ($ 17.27 + 110%)

( ii) Estimating Capital/ Startup and Operation and Maintenance Costs The types of industry cost associated with the information collection activity in the regulations are for labor and operation and maintenance of continuous parameter monitoring systems ( CPMS) for the PC source category only. The capital/ startup costs are a one time cost when a facility becomes subject to the regulation. The annual operation and maintenance costs are the ongoing costs to maintain the monitors and other costs such as contractor support cost, 13 1 We have assumed that each source will have five responses per year to comply with the rule reporting requirements at a total cost per source of $ 128.85 for storage, filing, photocopying, and postage. This estimate is based on the assumption that it takes 0.5 hrs to conduct these tasks at a clerical labor rate of $ 36.27 per hour for a total labor cost of $ 18.14 per response. First class postage is estimated at $ 7.63 per response for mailing of an one pound package and two one half pound packages to regulatory agencies. Thus, the total storage, filing, photocopying, and postage cost per response is $ 25.77.

2 Based on information we obtained from industry, we have determined that two PC sources of a total of four sources within the PC source category will use contractor support for CPMS O& M at a total cost of approximately $ 53,000 per source. photocopying and postage.

( iii) Capital/ Startup vs. Operation and Maintenance ( O& M) Costs Capital/ Startup vs. Operation and Maintenance ( O& M) Costs ( A) Source Category ( B) Startup Cost ($) for One Affected Facility ( C) Number of New Affected Facilities to Startup ( D) Total Startup Cost ( B X C) ( E) Annual O& M Costs ($) for One Affected Facility 1 ( F) Number of Affected Facilities with O& M ( G) Total O& M ( E X F)

AMF $ 0 0 $ 0 $ 128.85 3 $ 386.55 AR $ 0 0 $ 0 $ 128.85 2 $ 257.70 HF $ 0 0 $ 0 $ 128.85 1 $ 128.85 PC2 $ 0 0 $ 0 $ 53,128.85 2 $ 106,257.70 $ 128.85 2 $ 257.70 Total Number $ 0 $ 107,289 ( Rounded)

We have determined that there are no capital/ startup costs for this ICR since all sources within the four source categories have already purchased the necessary monitoring equipment to comply with the rule requirements. This estimate was made based on consultation with industry and OAQPS. Therefore, zero is shown in block 14( a), Total annualized capital/ startup costs, on the OMB 83 I form. 14 The total annual operation and maintenance costs for this ICR are approximately $ 107,289. This estimate is based on consultation with industry and OAQPS staff. We have determined that sources within the AMF, AR and HF source categories had the necessary CPMS at the time of rule promulgation. The one HF source subject to this rule is a large facility that had the necessary monitoring equipment at the time of rule promulgation because of established workpractices to ensure workers safety. The two AMF source sources subject to this rule had the necessary monitoring equipment at the time of rule promulgation due to compliance with the requirements of the Standards of Performance for Synthetic Fiber Production Facilities ( 40 CFR Part 60, Subpart HHH), addressed by ICR Number 1156.09, OMB Control Number 2060 0059), and the Standard of Performance for Volatile Organic Compound ( VOC) Emissions From Synthetic Organic Chemical Manufacturing Industry ( SOCMI) Air Oxidation Unit Processes ( 40 CFR Part 60, Subpart III), addressed by ICR Number 0998.06, OMB Control Number 2060 0197. The two AR sources subject to this rule had the necessary monitoring equipment at the time of rule promulgation due to compliance with the requirements of the Hazardous Organic NESHAP ( HON) from the SOCMI for Process Vents, Storage Vessels, Transfer Operations, and Wastewater rule ( 40 CFR Part 63, Subparts F, G, H and I), addressed by ICR Number 1414.05, OMB Control Number 2060 0282. This ICR is now included as part of the Consolidated Air Rule ( CAR) ICR Number 1854.03, OMB Control Number 2060 0443. Therefore, the operation and maintenance costs for CPMS for the AMF, AR and HF have already been addressed in the above ICRs. For the PC source category, we have determined that two sources have operation and maintenance costs associated with CPMS.

It should be noted that the industry costs in block 14 of the OMB 83 I form of the most recently approved ICR were erroneously based on the assumption that PC sources did not incur any capital/ startup costs and did not have incremental cost for operation and maintenance. For this ICR, there are no capital/ startup costs because the CPMS have already been installed but there are continuing operation and maintenance costs ( i. e., 53,000 per source). See Footnote number 2 regarding contractor support costs for the PC category. The total O& M cost estimate is the total of column G. These costs are 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 are estimated to be $ 107,289. 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 Agency burden and cost are mainly associated with the 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. 15 The average annual Agency cost during the three years of the ICR is estimated to be $ 9,055, as described in Table 1: Annual Agency Burden and Cost: National Emission Standards for Hazardous Air Pollutants for Source Categories: Generic Maximum Achievable Control Technology ( 40 CFR Part 63, Subpart YY), attached. This cost is based on the average hourly labor rate at a GS 12, Step 1, times a 1.6 benefits multiplication factor to account for government overhead expenses for a total of $ 38.30.

This rate is from the Office of Planning and Management ( OPM) " 2002 General Schedule" which excludes locality rates of pay. Details upon which this estimate is based appear in Table 1: Annual Agency Burden and Cost: National Emission Standards for Hazardous Air Pollutants for Source Categories: Generic Maximum Achievable Control Technology ( 40 CFR Part 63, Subpart YY), below.

6( d) Estimating the Respondent Universe and Total Burden and Costs Respondent Universe and Number of Responses Per Year Source Category ( A) Average Number of New Respondents per Year ( B) Number of Reports for New Sources ( C) Number of Existing Respondents ( D) Number of Reports for Existing Sources ( F) Number of Respondents that keep records but do not submit reports ( E) Total Annual Responses = ( AxB)+( CxD)+ F AMF 0 0 3 3 0 9 AR 0 0 2 3 0 6 HF 0 0 1 3 0 3 PC 0 0 4 3 0 12 Total Number 10 30 The number of total respondents is 10 since one PC source has closed and is no longer subject to the Generic MACT rule. This number is the sum of column A and column C of the Respondent Universe and Number of Responses Per Year table. This represents the number of existing sources plus the number of new sources averaged over the three year period ( i. e., number of new respondents per year multiplied by three years divided by two). It is shown in block 13 ( a), Number of respondents, on the OMB 83 I form.

The number of Total Annual Responses is 30. This is the number in column E of the Respondent Universe and Number of Responses Per Year table. It is shown in block 13 ( b), Total annual responses, on the OMB 83 I form. 16 The total annual labor costs are $ 238,592 which includes $ 8,000 for contractor labor support used by two PC sources. This number is not shown on the OMB 83 I form in block 13( c), Total hours requested. Only the burden hours are reflected in block 13( c). Details upon which this estimate is based appear in Tables 2a through 2d, Annual ( Source Category) Industry Burden and Cost: National Emission Standards for Hazardous Air Pollutants for Source Categories: Generic Maximum Achievable Control Technology ( 40 CFR Part 63, Subpart YY) standards. Specifically, these tables address each source category as follows: Table 2a  Annual AMF Production Industry Burden and Cost, Table 2b  Annual AR Production Industry Burden and Cost, Table 2c  Annual HF Production Industry Burden and Cost, and Table 2d  Annual PC Production Industry Burden and Cost.

The total annual capital and O& M costs to the regulated entity are approximately $ 107,289. This number is shown on the OMB 83 I form in block 14 ( c), Total annualized cost requested. These costs are detailed in section 6( b)( iii), Capital/ Startup vs. Operating and Maintenance ( O& M) Costs.

6( e) Bottom Line Burden Hours and Cost Tables The bottom line burden hours and cost tables for both the Agency and the respondents are attached.

6( f) Reasons for Change in Burden The industry hour burden in block 13 of the OMB 83 I form has decreased from the most recently approved ICR due to an adjustment based on the assumption that all existing sources have complied with the initial monitoring, recordkeeping and reporting requirements of the Generic MACT rule. We have also determined that one source within the PC source category has closed based on industry consultation.

The industry cost burden in block 14 of the OMB 83I form have increased since we have determined that two sources in the PC source category have continuing operation and maintenance costs ( i. e., $ 53,000 per source).

We have used the most recent labor rates from the United States Department of Commerce Bureau of Labor Statistics for year 2001 which are slightly higher than the labor rates for the most recently approved ICR.

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 17 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 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 Ms. Susan Auby, Collection Strategies Division ( Mail Code 2822T), Office of Environmental Information, United States Environmental Protection Agency, 1200 Pennsylvania Avenue, N. W., Washington, D. C. 20460 0001; and to the Office of Information and Regulatory Affairs, Office of Management and Budget, 725 17th Street, N. W., Washington, D. C. 20503, Attention: Desk Officer for EPA. Include the EPA ICR Number and OMB Control Number in any correspondence.

Part B of the Supporting Statement This part is not applicable because no statistical methods were used in collecting this information. 18 Attachment 1 TABLE 1: AVERAGE ANNUAL EPA RESOURCE REQUIREMENTS AS A RESULT OF STANDARDS A B C D E F Activity Person hours per response or Annual number of responses Total annual person Annual labor cost( C x Annual direct costs Total annual cost ( D + E)

1. Review reports a. Initial notification NA b. Performance test 2 0 0 0 0 $ 0 c. Compliance status 4 0 0 0 0 0 d. Performance test reports 4 0 0 0 0 0 e. 2 22 44 1,470 0 1,470 f. Semi annual summary 2 22 44 1,470 0 1,470 2. Compliance inspections a. Select site and review 4 1 4 134 0 134 b. Travel to/ from site 8 1 8 267 500 767 c. On site inspection 4 1 4 134 0 134 d. Prepare inspection 16 1 16 534 0 534 3. Enforcement action a. Notice of non compliance 160 1 160 5,344 0 5,344 b. Follow up compliance 32 1 32 1,069 0 1,069 c. Litigation NA Total 312 $ 10,421 $ 500 $ 10,921 NA  Not Applicable. 19 20


[Federal Register: October 7, 2008 (Volume 73, Number 195)]
[Notices]
[Page 58606]
[DOCID:fr07oc08-83]

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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2004-P-0474] (formerly Docket No. 2004P-0262)

Withdrawal of Approval of 128 Suitability Petitions; Correction

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice; correction.

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SUMMARY: The Food and Drug Administration (FDA) is correcting a notice
that appeared in the Federal Register of February 23, 2007 (72 FR
8184). The notice announced that FDA was withdrawing approval of 128
suitability petitions in accordance with the Pediatric Research Equity
Act of 2003 (PREA). FDA has determined that approval of the suitability
petition submitted by Roxane Laboratories, Inc. (Roxane), for lorazepam
oral solution, 1 milligram (mg)/10 milliliters (mL) (Docket No. FDA-
1994-P-0017),\1\ should not have been withdrawn and therefore
retroactively reinstates its approval of that petition. This document
also corrects errors in the petition numbers for two of the suitability
petitions listed in the notice.
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    \1\ This citizen petition was originally assigned docket number
94P-0199. The number was changed to FDA-1994-P-0017 as a result of
FDA's transition to its new docketing system (http://
www.Regulations.gov) in January 2008.

FOR FURTHER INFORMATION CONTACT: Cecelia M. Parise,Center for Drug
Evaluation and Research (HFD-600), Food and Drug Administration,5600
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Fishers Lane, Rockville, MD 20857,<PHONE_NUMBER>.

SUPPLEMENTARY INFORMATION: In the Federal Register of February 23, 2007
(72 FR 8184), FDA announced that it was withdrawing approval of 128
suitability petitions in accordance with PREA. Prior to PREA's
enactment, FDA had approved these suitability petitions to permit
abbreviated new drug applications (ANDAs) to be submitted for drugs
that had a different active ingredient, dosage form, or route of
administration than their reference listed drugs. In the notice, FDA
explained that the approval of these suitability petitions was being
withdrawn because ANDAs were never submitted and PREA requires that all
applications submitted on or after April 1, 1999, for a new active
ingredient, new indication, new dosage form, new dosing regimen, or new
route of administration contain an assessment of the safety and
effectiveness of the drug for the claimed indications in relevant
pediatric subpopulations unless the requirement is waived or deferred.
Thus, these suitability petitions no longer satisfied the conditions
for approval. The notice became effective on March 26, 2007.
    In response to the notice, Roxane sent FDA a letter dated March 1,
2007, regarding the withdrawal of approval of its suitability petition
for lorazepam oral solution, 1 mg/10 mL (Docket No. FDA-1994-P-0017).
Roxane stated that it submitted ANDA 74-648 for lorazepam oral
solution, 1 mg/10 mL, on the basis of the approval of its suitability
petition for lorazepam oral solution, 1 mg/10 mL (Docket No. FDA-1994-
P-0017). Roxane also stated that during the review of the ANDA, they
were asked to change the name of the product to lorazepam oral
solution, 0.5 mg/5 mL, and the ANDA was approved on March 18, 1997. FDA
has reviewed its records and determined that ANDA 74-648 was submitted
under suitability petition no. 94P-0199/CP1 before April 1, 1999;
therefore, approval of this suitability petition should not have been
withdrawn. This document corrects the error and retroactively
reinstates approval of the suitability petition for lorazepam oral
solution, 1 mg/10 mL (Docket No. FDA-1994-P-0017).
    In addition, FDA has determined that the notice contained incorrect
petition numbers for two of the suitability petitions. This document
corrects those errors.
    In FR Doc. E7-3043, appearing on page 8184 in the Federal Register
of Friday, February 23, 2007, the following corrections are made:
    1. On page 8185, in the table, in the first column, for Petition
No., ``85P-0095/CP1'' is corrected to read ``83N-0095/CP1''.
    2. On page 8187, in the table, in the first column, for Petition
No., ``92P-0332/CP1'' is corrected to read ``92P-0232/CP1''.
    3. On page 8187, in the table, in the first column, for Petition
No., ``94P-0199/CP1'' is deleted.

    Dated: September 29, 2008.
Jeffrey Shuren,
Associate Commissioner for Policy and Planning.
[FR Doc. E8-23721 Filed 10-6-08; 8:45 am]

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