INFORMATION COLLECTION REQUEST SUPPORTING STATEMENT FOR BEST MANAGEMENT PRACTICES FOR THE BLEACHED PAPERGRADE KRAFT AND SODA SUBCATEGORY AND THE PAPERGRADE SULFITE SUBCATEGORY OF THE PULP, PAPER, AND PAPERBOARD POINT SOURCE CATEGORY ( 40 CFR PART 430)

EPA ICR NUMBER 1829.02 OMB CONTROL NUMBER 2040 0207 February 2002 U. S. Environmental Protection Agency Office of Water Engineering and Analysis Division 1200 Pennsylvania Avenue, NW Washington, D. C. 20460 i TABLE OF CONTENTS 1. IDENTIFICATION OF THE INFORMATION COLLECTION . . . . . . . . . . . . . . . . . . 1 1( a) Title of the Information Collection . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 1 1( b) Short Characterization/ Abstract . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 1 2. NEED FOR AND USE OF THE COLLECTION . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 2 2( a) Need/ Authority for the Collection . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 2 2( b) Practical Utility/ Users of the Data . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 2 3. NONDUPLICATION, CONSULTATIONS, AND OTHER COLLECTION CRITERIA . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 3 3( a) Nonduplication . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 3 3( b) Public Notice Required Prior to ICR Submission . . . . . . . . . . . . . . . . . . . . . . . . . 3 3( c) Consultations . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 3 3( d) Effects of Less Frequent Data Collection . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 3 3( e) General Guidelines . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 4 3( f) Confidentiality . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 4 3( g) Sensitive Questions . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 4 4. THE RESPONDENTS AND THE INFORMATION REQUESTED . . . . . . . . . . . . . . . 4 4( a) Respondents and Sic Codes . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 4 4( b) Information Requested . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 4 4( c) Respondent Activities . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 6 5. THE INFORMATION COLLECTED AGENCY ACTIVITIES, COLLECTION METHODOLOGY, AND INFORMATION MANAGEMENT . . . . . . . . . . . . . . . . . . . 7 5( a) Agency Activities . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 7 5( b) Collection Methodology and Management . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 7 5( c) Small Entity Flexibility . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 7 5( d) Collection Schedule . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 8 6. ESTIMATING THE BURDEN AND COST OF THE COLLECTION . . . . . . . . . . . . . 8 6( a) Estimating Respondent Burden . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 8 6( b) Estimating Agency Burden . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 12 6( c) Bottom Line Burden and Costs Tables . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 13 6( d) Reasons for Change of Burden . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 14 6( e) Burden Statement . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 14 ii LIST OF TABLES Table 1. Summary of Mill Status . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 9 Table 2. Mill Labor for Amendment and Review of BMP Plan, Reporting, Monitoring, Recordkeeping and Training . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 10 Table 3. Mill Costs for Amendment and Review of BMP Plan, Reporting, Monitoring, Recordkeeping and Training . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 10 Table 4. Recurring Respondent Burden and Costs . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 11 Table 5. Summary of Burden and Costs to Respondents and Government . . . . . . . . . . . . . . 11 Table 6. Bottom Line Initial Burden and Costs Based in 2000 Dollars . . . . . . . . . . . . . . . . 12 Table 7. Bottom Line Recurring Burden and Costs Based in 2000 Dollars . . . . . . . . . . . . 12 1 1. IDENTIFICATION OF THE INFORMATION COLLECTION 1( a) Title of the Information Collection ICR: Best Management Practices for the Bleached Papergrade Kraft and Soda Subcategory and the Papergrade Sulfite Subcategory of the Pulp, Paper, and Paperboard Point Source Category ( EPA ICR No. 1829.02).

1( b) Short Characterization/ Abstract This Information Collection Request ( ICR) presents estimates of the burden and costs to the regulated community ( approximately 95 bleached papergrade kraft, soda and sulfite mills) and NPDES permit and pretreatment control authorities for data collection and recordkeeping associated with implementation of the Best Management Practices requirements of the Pulp and Paper Effluent Limitations Guidelines and Standards ( 40 CFR Part 430.03). This is a renewal ICR.

The Clean Water Act ( CWA) authorizes the Environmental Protection Agency ( EPA) to include Best Management Practices ( BMPs) in effluent limitations guidelines and standards regulations. EPA's legal authority to promulgate BMPs is found in Section 304( e), Section 307( b) and ( c), Section 308( a), Section 402( a)( 1)( B) and Section 501( a) of the Clean Water Act, 33 U. S. C. § 1251, et. seq. EPA also relies on 40 CFR 122.44( k). The BMP regulation is consistent with the Pollution Prevention Act of 1990, 42 U. S. C. § 13101, et. seq.

The objectives of the BMPs are to prevent leaks and spills of spent pulping liquors, soap and turpentine for mils in bleached papergrade kraft and soda ( Subpart B) and papergrade sulfite ( Subpart E) subcategories; and, to contain, collect and recover at the immediate process area, or otherwise control, those leaks, spills and intentional diversions of spent pulping liquor that do occur. EPA has emphasized control of spent pulping liquors, intentional liquor diversions, soap and turpentine for the following reasons: ( 1) losses of spent pulping liquor contribute significant portions of untreated wastewater loadings and discharge loadings of color, oxygen demanding substances, and non chlorinated toxic compounds from chemical pulp mills; ( 2) spent pulping liquor spills and intentional liquor diversions are a principal cause of upsets and loss of efficiency of biological treatment systems that are used for treatment of Subpart B and E mill wastewaters, thus contributing to increased effluent discharges of toxic, conventional and nonconventional pollutants; ( 3) soap and turpentine are substances that are highly toxic to biological treatment systems; and ( 4) control of spent pulping liquors is a form of pollution prevention that can result in cost savings, less demand for make up pulping chemicals, increased energy efficiency, more effective wastewater treatment and incidental reductions in atmospheric emissions of total reduced sulfur ( TRS) compounds from kraft mills and volatile hazardous air pollutants from Subpart B and E mills.

The regulation requires that owners or operators of Subpart B and E mills prepare and implement site specific BMPs for management of spent pulping liquors and prevent and control 2 losses of soap and turpentine. In addition, the regulation requires mills to monitor the effectiveness of BMP implementation on a continuing basis by tracking the influent to treatment wastewater loading. EPA has structured the BMP regulation to provide maximum flexibility to the regulated community and to minimize administrative burdens on NPDES permit and pretreatment control authorities that regulate Subpart B and E mills. In fact, the final BMP regulation provides flexibility for mill owners or operators to select any reasonable measure of organic loading and/ or spent pulping liquor losses to monitor the effectiveness of BMPs. Also, the final regulation is less prescriptive than the proposed rule with regard to inspection, repair and log keeping requirements. EPA determined that the final rule language allows mills to use existing maintenance and repair tracking systems to fulfill the aforementioned requirements thereby reducing burden to the industry. By promulgating a national regulation for BMPs, EPA has effectively removed substantial administrative and technical burdens on NPDES and pretreatment control authorities to devise and implement these requirements on a case by case basis through their permit programs.

In summary, implementation of effective BMPs has been shown to provide a potential significant payback to a mill. In one incident at an indirect discharging kraft mill in the southeastern U. S. in July 1993, a process upset caused a release of excess spent pulping liquor to the POTW, which then caused a fish kill. The resulting costs for cleanup and mill shutdown were approximately equal to the cost of full implementation of BMPs at the mill.

2. NEED FOR AND USE OF THE COLLECTION 2( a) Need/ Authority for the Collection In the BMP regulation, EPA is requiring mills with pulp production Subpart B and E Subcategories to develop and implement BMPs to prevent or otherwise contain leaks and spills and to control intentional diversions of spent pulping liquor, soap and turpentine. These BMPs apply to direct and indirect discharging mills within these subcategories and are intended to reduce wastewater loadings of color, oxygen demanding substances, and non chlorinated toxic compounds and hazardous substances in mill wastewater, with incidental reductions in conventional water pollutants and certain air pollutants.

EPA's legal authority to promulgate this BMP regulation is found in Section 304( e), Section 307( b) and ( c), Section 308( a), Section 402( a)( 1)( B), Section 402( a)( 2) and Section 501( a) of the Clean Water Act, 33 U. S. C. § 1251, et seq. EPA also relies on 40 CFR § 122.44( k). This BMP regulation is also consistent with the Pollution Prevention Act of 1990, 42 U. S. C. § 13101, et seq. For further discussion of EPA's legal authority to require mills to develop and implement BMPs, including the information collection requirements discussed in this document, see the BMP Technical Support Document ( BMP TSD, DCN 14489).

2( b) Practical Utility/ Users of the Data The primary users of the information generated through BMP Plans will be the owners and operators of the Subpart B and E pulp and paper mills. EPA intends that the data collected ( in the form of BMP monitoring reports) will be used by mill operators to track the effectiveness and 3 progress of BMP implementation through comparisons with action levels established by the mill. Under the regulation, whenever monitoring results exceed action levels for particular periods, the mill must complete an investigation or corrective action, as appropriate.

EPA also expects that the monitoring reports required by the BMP regulations will be used by NPDES and pretreatment control authorities to determine compliance with the regulation. EPA anticipates that State and local control authorities will conduct detailed technical reviews of BMP Plans only in the event the monitoring reports indicate noncompliance with BMP conditions contained in the mill's NPDES permit or pretreatment control mechanism.

3. NONDUPLICATION, CONSULTATIONS, AND OTHER COLLECTION CRITERIA 3( a) Nonduplication EPA has examined all other reporting requirements contained in the Clean Water Act and 40 CFR Parts 122, 123, 124, 125, 501, and 503. The Agency also has consulted the following sources of information to determine if similar or duplicative information is available elsewhere:

° the EPA Information Systems Inventory, ° the Government Information Locator System ( GILS), and ° the Toxic Chemical Release Inventory.

Examination of these databases revealed no duplicative reporting requirements.

EPA has examined a similar reporting requirement for notice of spills under the Resource Conservation and Recovery Act ( RCRA) for duplication of the requirements of this regulation. The requirements for reporting of pollutant releases under RCRA is different than reporting of spills or losses of spent pulping liquor, soap or turpentine outside the immediate process areas under this regulation. EPA has concluded that there is no other way to obtain the compliance assessment information addressed in this ICR.

3( b) Public Notice Required Prior to ICR Submission OMB approved this information collection ( ICR No. 1829.01) on January 31, 1999 and assigned control number 2040 0207. EPA is now soliciting comments on the renewal of this ICR ( No. 1829.02) prior to submission to OMB for approval.

3( c) Consultations EPA had extensive discussions with the regulated community and selected federal and State NPDES permitting authorities regarding development of this regulation and the attendant recordkeeping and reporting requirements.

3( d) Effects of Less Frequent Data Collection 4 The regulation requires collection of daily influent to treatment data. Most mill operators collect such data independent of this requirement for purposes of monitoring and optimizing wastewater treatment plant operations. Because spill, leaks and losses of spent pulping liquors can and do occur frequently and at any time, less frequent monitoring would not provide the timely information to mill operators to identify and respond to a spill, leak or loss event.

3( e) General Guidelines This information collection is consistent with OMB guidelines contained in 5 CFR 1320.6 and 1320.12.

3( f) Confidentiality EPA does not expect that confidential business information or trade secrets will be required from mill operators as part of this ICR. In the event that the information submitted in conjunction with this ICR is claimed to be confidential business information ( CBI) by the mill owner or operator, the information would then be handled pursuant to 40 CFR Part 2 when EPA is the permitting authority and applicable State and local government rules and regulations governing CBI when States or local governments are the permitting or pretreatment control authorities. Any mills that may consider asserting CBI claims should do so carefully as they may be asked to support any such claims at a later date.

3( g) Sensitive Questions The reporting requirements addressed in this ICR do not include sensitive questions.

4. THE RESPONDENTS AND THE INFORMATION REQUESTED 4( a) Respondents and SIC Codes The respondents for this ICR will be approximately 95 direct and indirect discharging Subpart B and E pulp mills in the Pulp, Paper and Paperboard Manufacturing Category ( SIC 2611, 2631). Government respondents are estimated to be 35 State and local authorities ( approximately 26 State governments for direct discharging mills and 9 local governments for indirect discharging mills) for preparation of new NPDES permits and pretreatment conditions for implementing the BMP regulation and conducting detailed technical reviews of BMP Plans in the event the monitoring reports indicate noncompliance with BMP conditions contained in the mill's NPDES permit or pretreatment control mechanism.

4( b) Information Requested The BMP regulations at 40 CFR 430.03 include the following major components: ( 1) development, review and certification of a BMP plan; ( 2) amendment and periodic review of the BMP plan; ( 3) reporting of spills; ( 4) additional monitoring and reporting; and ( 5) additional recordkeeping. See 40 CFR 430.03( c) through ( i) and the BMP TSD for more detailed information on the requirements. The development, review, and certification of a BMP plan is an initial one time component of the BMP regulations, and the associated burden was already 5 accounted for in the original ICR ( No. 1829.01). Therefore, that burden is not included in this renewal ICR.

( 1) Development, review and certification of a BMP plan [ § 430.03( d) and ( f)]:

Central to the BMP regulation is the development of a BMP plan. This plan is intended to be the initial and ongoing BMP planning and implementation tool for mills. The BMP plan must, at a minimum, include programs: ( a) to identify and repair leaking equipment; ( b) to track equipment repairs; ( c) to train personnel; ( d) to report and evaluate spills; ( e) to review planned mill modifications; and ( f) to establish wastewater treatment system influent action levels ( including an initial six month monitoring program).

Also, as part of the BMP plan development, each mill must conduct a detailed engineering review of the pulping and chemical recovery areas to determine the magnitude and routing of potential leaks, spills, and intentional diversions of spent pulping liquors, soap and turpentine and to determine the adequacy of containment and collection facilities ( see 40 CFR 430.03 ( d) ( 3) for additional details). The BMP plan and any amendments require review by the senior technical manager and certification by the mill manager.

( 2) Amendment and periodic review of a BMP Plan [ § 430.03( e)]:

Owners or operators must amend their BMP Plans whenever there is a change in mill design, construction, operation, or maintenance that materially affects the potential for leaks or spills of spent pulping liquor, soap or turpentine from the immediate process areas. Notwithstanding this requirement, owners or operators must complete a review and evaluation of their BMP Plans at least once every five years and amend the plan within three months of such review, if warranted. As mentioned above, any BMP plan amendments require review by the senior technical manager and certification by the mill manager.

( 3) Reporting of spills [ § 430.03( c)( 5)]:

Owners or operators are required to prepare brief reports of spills of spent pulping liquor, soap or turpentine not contained in the immediate process area ( e. g., a failure of the management practices and control systems identified by the owner or operator in the BMP Plan). The report must list the equipment items involved, the circumstances leading to the incident, the effectiveness of corrective actions taken and plans to implement future changes. These reports must be maintained by the mill owner or operator for three years and they need only be submitted to the NPDES permit or pretreatment control authority upon request.

( 4) Additional monitoring and reporting [ § 430.03 ( c)( 3), ( g), ( h) and ( i)]:

Mills are required to operate continuous, automatic monitoring systems that the mill determines are necessary to detect and control leaks, spills, and intentional diversions of spent pulping liquor, soap, and turpentine. See 40 CFR 430.03( c)( 3). As part of this requirement, all mills ( with the exception of new sources) are required to perform two six month monitoring programs in order to determine the characteristics ( or action levels) of their wastewater treatment system influent. See 40 CFR 430.03( h). ( New sources are required to perform only one 6 six month monitoring program for this purpose. See 40 CFR 430.03( h)( 5).) All mills are also required to perform additional monitoring to revise those action levels after any change in mill design, construction, operation, or maintenance that materially affects the potential for leaks or spills or spent pulping liquor, soap, or turpentine from the immediate process area. See 40 CFR 430.03( h)( 6). The regulation also requires all mills to conduct daily monitoring of wastewater treatment system influent for the purpose of detecting leaks and spills, tracking the effectiveness of the BMPs, and detecting trends in spent pulping liquor losses. See 40 CFR 430.03( i).

Mill operators are required to provide their NPDES permit or pretreatment control authorities reports of the monitoring required by the BMP regulation. See 40 CFR 430.03( i)( 4). The reports must include a summary of the monitoring results, the number and dates of exceedances of the applicable action levels, and brief descriptions of any corrective actions taken to respond to such exceedances. Submission of such reports shall be at the frequency established by the NPDES permit or pretreatment control authority, but in no case less than once per year.

( 5) Recordkeeping requirements [ § 430.03( g)]:

The regulation requires that certain equipment repair records, records of employee training, reports of spills outside the immediate process area, and records of monitoring conducted as part of the BMP program be maintained for three years.

4( c) Respondent Activities Mill respondent activities include the following:

Preparing basic information. This includes reviewing regulatory and permit requirements; conducting initial and refresher employee training; developing and certifying the BMP Plan; tracking equipment repair; conducting influent to treatment monitoring; preparing reports of spill incidents outside the immediate process area; and, making reports to the NPDES permit or pretreatment control authority.

Maintaining records. All mills in Subparts B and E must keep records of monitoring information, equipment repair, employee training, and spill reports as required by the regulation.

State permitting and local pretreatment control authority activities include the following:

Preparing NPDES permit and pretreatment conditions. This includes reviewing the development of each mill's BMP plans in accordance with 40 CFR 430.03. State permitting and local pretreatment control authority respondents are responsible for the incorporation of BMP provisions in NPDES permits and pretreatment conditions.

Periodic Review. State and local respondents are authorized to conduct periodic review of monitoring reports submitted by each mill and perform compliance reviews. Detailed technical reviews of BMP Plans may be performed in the event the monitoring reports indicate noncompliance with BMP conditions contained in the mill's NPDES permit or pretreatment control mechanism. 7 The initial one time burden associated with mill respondents conducting initial employee training and developing and certifying the BMP plan and State permitting and local pretreatment control authority activities in preparing NPDES permit and pretreatment conditions was already accounted for in the original ICR ( No. 1829.01) and, therefore, is not included in this renewal ICR.

5. THE INFORMATION COLLECTED AGENCY ACTIVITIES, COLLECTION METHODOLOGY, AND INFORMATION MANAGEMENT 5( a) Agency Activities Upon approval of this renewal ICR, permittees must continue to maintain records as described above in Section 4( c) and at least annually, must submit to the NPDES or pretreatment control authority a report summarizing the results of daily monitoring, the number and dates of any exceedances of action levels and corrective actions taken when action levels are exceeded. The permitting authority can be either an approved NPDES State or one of EPA's regional offices. The permitting authority or pretreatment control authority is authorized to conduct compliance audits of facility records, review the data, and where necessary, conduct follow up actions. Follow up activities may include informal contact with the permittee ( by telephone or letter) to discuss the cause of any exceedances of action levels and responses taken to correct the exceedences. Because the requirements to implement the BMPs and maintain records will be incorporated in a mill's NPDES permit or pretreatment control mechanism as enforeceable conditions, the permitting authority will be responsible for assessing whether the mill is properly maintaining records ( including the BMP Plan) and thus, performing equipment repairs, employee training and responding to any exceedance events in a timely manner. Review of monitoring records may also be helpful to the permit writers in the development of future NPDES permit conditions.

The extent to which EPA reviews data will depend on available resources and the specific reviewing procedures of the permitting authority ( State or EPA region). In NPDES States, State environmental agencies generally review permittee data. EPA regions may also review data from major permittees in NPDES States while performing program oversight functions, particularly since the assessment of compliance is subjective.

5( b) Collection Methodology and Management As with the minimum effluent monitoring requirements associated with the Cluster Rule, mill owners and operators are required to maintain information for in mill use to assess BMP effectiveness and for preparation of the summary report of daily monitoring. The regulation provides a framework for compliance, but mill owner and operators can develop the necessary data collection and management protocols to achieve an effective BMP program. EPA expects that mill owners and operators will most likely use existing in mill and effluent monitoring capabilities to perform the daily monitoring and existing computer capabilities to develop and maintain records. 8 5( c) Small Entity Flexibility EPA has certified that the Cluster Rules, including the BMP requirements will not have a significant economic impact on a substantial number of small entities. Only four mills are considered " a small business concern" as defined by SBA regulations. EPA does not believe this is a substantial number of small entities as that term is used in the RFA ( see Section X. C. of the Preamble to the final Cluster Rules published in the Federal Register on April 15,1998 ( see 63 FR 18611).

5( d) Collection Schedule The majority of information collection activities included in this ICR are anticipated to coincide with existing monitoring, recordkeeping, and reporting requirements ( e. g., Discharge Monitoring Reports), although some recordkeeping may be non routine, such as spill reporting.

° Submit summary report of daily monitoring to NPDES permit and pretreatment control authorities ( minimum frequency is annual, but frequency to be determined by the permit or pretreatment control authority): Immediately ° Complete second six month monitoring program and establish revised action levels: January 15, 2002 ° Initiate separate six month monitoring program and establish revised action levels after any change in mill design, construction, and operation or maintenance: Reasonable timeframe after change at mill 6. ESTIMATING THE BURDEN AND COST OF THE COLLECTION 6( a) Estimating Respondent Burden and Costs Burden and costs will vary based upon mill complexity, see Table 1. Tables 2 presents estimates of the recurring mill respondent burdens for labor hours and costs associated with this ICR. The assumptions made are listed in each Table. A summary of the mill respondents' burden hours and costs is presented in Table 3. A brief description of the basis for the burden estimates is presented below.

( 1) Development, review and certification of a BMP plan:

Development of a site specific BMP plan is a one time initial burden. As part of the BMP plan development, mills must also establish a training program for technical personnel. This training program must include both an initial training effort and refresher training, which at a minimum, must be performed annually. The burden associated with the development of the BMP plan and initial training were already accounted for in the original ICR ( No. 1829.01) and are, therefore, not included in the burden estimates of this renewal ICR. The refresher training is based on bi annual effort of four hours each, including nine operators and one consultant acting as 9 trainer. The total burden for refresher training per mill is estimated to be 72 hours of operator effort ( at $ 20 per hour) and eight hours of consultant engineering effort ( at $ 65 per hour).

( 2) Amendment and periodic review of a BMP Plan:

EPA anticipates less than 50 hours of mill labor per amendment and has based the ICR burden on an assumption that each mill would need to amend its BMP plan twice every five years for an annual burden of 20 hours, estimating 18 hours of mill engineer effort ( at $ 65 per hour) and two hours of management effort ( at $ 100 per hour), which is included in the annual estimates presented in Tables 2 and 3.

( 3) Reporting of spills:

EPA anticipates that the burden of preparing a spill report is approximately four hours and can be conducted by a mill engineer ( at $ 65 per hour). ICR burden is calculated on an annual basis using an assumption of one spill per mill per month and is included in the annual estimates presented in Table 2 and 3.

( 4) Additional monitoring and reporting:

Mills are required to operate continuous, automatic monitoring systems that the mills determine are necessary to detect and control leaks, spills, and intentional diversions of spent pulping liquor, soap, and turpentine. The burden for designing, testing, and operating the monitoring system, expressed in the form of costs, is included in the compliance cost estimates developed for the regulation ( see Table 9.2 of the BMP TSD, DCN 14489).

In addition, all mills with the exception of new sources are required to perform two six month monitoring programs in order to determine the characteristics ( or action levels) of their wastewater treatment system effluent. See 40 CFR 430.03( h). ( New sources are required to perform only one six month monitoring program for this purpose.) All mills are also required to perform additional monitoring to revise those action levels after any change in mill design, construction, operation, or maintenance that materially affects the potential for leaks or spills or spent pulping liquor, soap, or turpentine from the immediate process area. The effort required to implement the initial monitoring program and perform the associated statistical analysis to establish the action levels is included in the compliance cost estimates developed for the regulation, and the burden to perform monitoring to revise those action levels is included in the incremental monitoring burden discussed below.

The regulation also requires all mills to conduct daily monitoring of wastewater treatment system influent for the purpose of detecting leaks and spills, tracking the effectiveness of the BMPs, and detecting trends in spent pulping liquor losses. EPA estimates the burden associated with this monitoring to be an increment of one additional hour per day of operator time over existing burden imposed by minimum monitoring; this increment is included in the annual estimates shown in Tables 2 and 3. Costs for monitoring equipment were included as initial capital costs in the original ICR ( No. 1829.01). Therefore, these one time costs are not included in the burden estimates of this renewal ICR. 10 Mill operators are required to provide their NPDES permit or pretreatment control authorities reports of the monitoring required by the BMP regulation. Submission of such reports shall be at the frequency established by the NPDES permit or pretreatment control authority, but in no case less than once per year. EPA has based the burden estimates on a semi annual reporting frequency and estimates that each report will take 16 hours to complete, based on 14 hours of mill engineer effort and two hours of management effort ( also included in estimates presented in Tables 2 and 3).

( 5) Recordkeeping requirements:

Burden estimates for recordkeeping are based on an incremental level of effort to comply with BMP requirements consisting of two to four hours per month for the operators/ shift supervisors over current shift log recordkeeping ( at $ 20 per hour), two to four hours per months for mill engineers ( at $ 65 per hour), and two hours per month for clerical support ( at $ 15 per hour). These burden estimates are also included in the annual estimates presented in Tables 2 and 3 .

( 6) NPDES permit provisions, pretreatment conditions and periodic review The initial burden to State NPDES permitting and pretreatment control authorities for preparation of NPDES permit provisions and pretreatment conditions for implementing the BMP regulation was already accounted for in the new ICR. Therefore, this burden is not included in this renewal ICR. EPA estimates an incremental ten hours per year per facility for reviewing periodic ( e. g., annual or semi annual) monitoring reports and conducting compliance reviews.

Estimates for Federal and State labor rates were based on the 1998 US Labor department figures adjusted to 2000 dollars with the Consumer Price Index, whereby the average annual salary for Federal and State employees is $ 43,926; this is equivalent to the salary of a GS 9, Step 10 Federal employee. At 2,080 available labor hours per year, the hourly rate is $ 21.12. Overhead costs for Federal and State employees are estimated by EPA to be 60 percent ( EPA ICR Handbook), or $ 12.67 per hour, which results in a total hourly rate of $ 33.79 ($ 21.12 + $ 12.67).

Table 1. Summary of Mill Status CATEGORY Simple Moderately Complex Complex Total Kraft & Soda 41 30 13 84 Sulfite 11 0 0 11 Total Mills 52 30 13 95 Table 2. Mill Labor for Amendment and Review of BMP Plan, Reporting, Monitoring, Recordkeeping and Training ( hours) 11 Item Kraft & Soda Sulfite TOTAL HOURS Simp le Moderatel y Complex Compl ex Total Simple Total Amendment and Review of BMP Plan 820 600 260 1,680 220 220 1,900 Reporting of Spills 1,968 1,440 624 4,032 528 528 4,560 Additional Monitoring and Reporting 16,27 7 11,910 5,161 33,348 4,367 4,367 37,715 Recordkeepin g 2,952 2,880 1,560 7,392 792 792 8,184 Refresher Training 3,280 2,400 1,040 6,720 880 880 7,600 TOTAL 59,959 Table 3. Mill Costs for Amendment and Review of BMP Plan, Reporting, Monitoring, Recordkeeping and Training Item Kraft & Soda Sulfite TOTAL COSTS Simple Moderatel y Complex Complex Total Simple Total Amendment and Review of BMP Plan $ 56,170 $ 41,100 $ 17,810 $ 115,080 $ 15,070 $ 15,070 $ 130,150 Reporting of Spills $ 127,920 $ 93,600 $ 40,560 $ 262,080 $ 34,320 $ 34,320 $ 296,400 Additional Monitoring and Reporting $ 390,320 $ 285,600 $ 123,760 $ 799,680 $ 104,720 $ 104,72 0 $ 904,400 12 Recordkeepin g $ 98,400 $ 108,000 $ 57,720 $ 264,120 $ 26,400 $ 26,400 $ 290,520 Refresher Training $ 80,360 $ 58,800 $ 25,480 $ 164,640 $ 21,560 $ 21,560 $ 186,200 TOTAL $ 1,807,670 13 Table 4. Recurring Mill Respondent Burden and Costs Status Total Labor Hours Total Recurring Costs Kraft & Soda Simple 25,297 $ 753,170 Moderately Complex 19,230 $ 587,100 Complex 8,645 $ 265,330 Total Kraft & Soda 53,172 $ 1,605,600 Sulfite Simple 6,787 $ 202,070 Total Sulfite 6,787 $ 202,070 TOTAL MILLS 59,959 $ 1,807,670 6( b) Estimating Agency Burden EPA estimates an incremental labor burden of approximately eight hours per facility for a total of 760 hours annually for the BMP regulation. This burden accounts for anticipated support of State and local authority efforts described in Section 6( a). Using the hourly labor rate of $ 33.79 ( see Section 6( a)( 6)), recurring Agency costs are estimated at $ 25,680. A summary of the Agency burden hours and costs is presented in Table 5.

Table 5. Summary of Burden and Costs to Respondents and EPA Category Total Labor Hours Total Costs Respondents  Annual Burden Kraft & Soda Mills Sulfite Mills Total 53,172 6,787 59,959 $ 1,605,600 $ 202,070 $ 1,807,670 14 Respondents  State & Local Governments Annual Burden 950 $ 32,100 EPA Annual Burden 760 $ 25,680 6( c) Bottom Line Burden and Costs Tables The bottom line burden hours and cost tables for respondents are the summaries of all the hours and costs incurred for all activities. There are no Operating and Maintenance costs associated with this Information Collection Request.

( 1) Respondent Tally The bottom line respondent ( mills, State permitting and local pretreatment authorities) tally is presented in Table 6.

Table 6. Total Estimated Respondent Burden and Cost Summary ( 2000 Dollars)

Category Number of Respondents Total Hours Per Year Total Labor Cost Per Year Respondents  Subpart B and E mills 95 59,959 $ 1,807,670 Respondents  State and local authorities 35 950 $ 32,100 Total Respondents 130 60,909 $ 1,839,770 ( 2) Agency Tally The bottom line Agency tally is presented in Table 7. 15 Table 7. Total Estimated Agency Burden and Cost Summary ( 2000 Dollars)

Category Total Hours Per Year Total Labor Cost Per Year Agency 760 $ 25,680 6( d) Reasons for Changes in Burden As this is a renewal information collection, the change in burden for this collection includes adjusting from 1998 to 2000 dollars and to eliminate the initial burden and costs incurred by respondents and EPA that were already accounted for in the original ICR ( No. 1829.01).

6( e) Burden Statement The recurring burden for a mill to periodically review and amend the BMP plan, prepare spill reports, perform additional monitoring, hold refresher training, and conduct recordkeeping and reporting is estimated to be 617, 641 and 665 hours annually per mill for simple, moderately complex and complex mills, respectively. The total recurring cost for mills associated with the BMP requirements is estimated at $ 1,807,670.

The recurring burden to State NPDES and pretreatment control authorities is estimated at ten hours per year per facility for reviewing periodic ( e. g., annual or semi annual) monitoring reports and conducting compliance reviews. The total recurring costs for State NPDES and pretreatment control authorities is estimated at $ 32,100.

The recurring burden to EPA is estimated at eight hours per year per facility for support of State and local authority efforts in reviewing periodic ( e. g., annual or semi annual) monitoring reports and conducting compliance reviews. The total recurring costs for EPA is estimated at $ 25,680.

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.

Send comments on the need for this information, the accuracy of the provided burden estimates, and any suggested methods for minimizing respondent burden, including through the use 16 of automated collection techniques to the Director, Collection Strategies Division, U. S. Environmental Protection Agency ( 2822), 401 M. St. S. W., Washington, D. C. 20460; 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 ( 1829.02) in any correspondence.


Collocated sampling PM2.5,        Collocated          15%...............  Every 12 days.....  Primary sampler
 PM10	2.5.                         samplers.                                                   concentration and
                                                                                duplicate sampler
                                                                                concentration.
Performance evaluation program    Collocated          1. 5 valid audits   Over all 4          Primary sampler
 PM2.5, PM10	2.5.                  samplers.           for primary QA      quarters.           concentration and
                                                       orgs, with <=5                          performance
                                                       sites.                                  evaluation
                                                      2. 8 valid audits                        sampler
                                                       for primary QA                          concentration.
                                                       orgs, with >5
                                                       sites.
                                                      3. All samplers in
                                                       6 years.
----------------------------------------------------------------------------------------------------------------
                                                 Manual Methods
----------------------------------------------------------------------------------------------------------------
Collocated sampling PM10, TSP,    Collocated          15%...............  Every 12 days PSD-- Primary sampler
 PM10	2.5, PM2.5, Pb-TSP, Pb-      samplers.                               every 6 days.       concentration and
 PM10.                                                                                duplicate sampler
                                                                                concentration.
Flow rate verification PM10 (low  Check of sampler    Each sampler......  Once every month..  Audit flow rate
 Vol), PM10	2.5, PM2.5, Pb-PM10.   flow rate.                                                  and measured flow
                                                                                rate indicated by
                                                                                the sampler.
Flow rate verification PM10       Check of sampler    Each sampler......  Once every quarter  Audit flow rate
 (High-Vol), TSP, Pb-TSP.          flow rate.                                                  and measured flow
                                                                                rate indicated by
                                                                                the sampler.
Semi-annual flow rate audit       Check of sampler    Each sampler, all   Once every 6        Audit flow rate
 PM10, TSP, PM10	2.5, PM2.5, Pb-   flow rate using     locations.          months.             and measured flow
 TSP, Pb-PM10.                     independent                                                 rate indicated by
                                   standard.                                                   the sampler.
Pb audit strips Pb-TSP, Pb-PM10.  Check of            Analytical........  Each quarter......  Actual
                                   analytical system                                           concentration and
                                   with Pb audit                                               audit
                                   strips.                                                     concentration.
Performance evaluation program    Collocated          1. 5 valid audits   Over all 4          Primary sampler
 PM2.5, PM10	2.5.                  samplers.           for primary QA      quarters.           concentration and
                                                       orgs, with <=5                          performance
                                                       sites.                                  evaluation
                                                      2. 8 valid audits                        sampler
                                                       for primary QA                          concentration.
                                                       orgs, with >5
                                                       sites.
                                                      3. All samplers in
                                                       6 years.
Performance evaluation program    Collocated          1. 1 valid audit    Over all 4          Primary sampler
 Pb-TSP, Pb-PM10.                  samplers.           and 4 collocated    quarters.           concentration and
                                                       samples for                             performance
                                                       primary QA orgs,                        evaluation
                                                       with >5 sites.                          sampler
                                                      2. 2 valid audits                        concentration.
                                                       and 6 collocated                        Primary sampler
                                                       samples for                             concentration and
                                                       primary QA orgs,                        duplicate sampler
                                                       with >5 sites.                          concentration.
----------------------------------------------------------------------------------------------------------------
\1\ Effective concentration for open path analyzers.
\2\ Corrected concentration, if applicable, for open path analyzers.

0
20. Appendix C to Part 58 is amended by adding paragraph 2.10 to read
as follows:
* * * * *

    2.10 Use of Pb-PM10 at SLAMS Sites.
    2.10.1 The EPA Regional Administrator may approve the use of a
Pb-PM10 FRM or Pb-PM10 FEM sampler in lieu of
a Pb-TSP sampler as part of the network plan required under part
58.10(a)(4) in the following cases.
    <IP_ADDRESS> Pb-PM10 samplers can be approved for use at
the non-source-oriented sites required under paragraph 4.5(b) of

Appendix D to part 58 if there is no existing monitoring data
indicating that the maximum arithmetic 3-month mean Pb concentration
(either Pb-TSP or Pb-PM10) at the site was equal to or
greater than 0.10 micrograms per cubic meter during the previous 3
years.
    <IP_ADDRESS> Pb-PM10 samplers can be approved for use at
source-oriented sites required under paragraph 4.5(a) if the
monitoring agency can demonstrate (through modeling or historic
monitoring data from the last 3 years) that Pb concentrations
(either Pb-TSP or Pb-PM10) will not equal or exceed 0.10
micrograms per cubic meter on an arithmetic 3-month mean and the
source is expected to emit a substantial majority of its Pb in the
fraction of PM with an aerodynamic diameter of less than or equal to
10 micrometers.
    2.10.2 The approval of a Pb-PM10 sampler in lieu of a
Pb-TSP sampler as allowed for in paragraph 2.10.1 above will be
revoked if measured Pb-PM10 concentrations equal or
exceed 0.10 micrograms per cubic meter on an arithmetic 3-month
mean. Monitoring agencies will have up to 6 months from the end of
the 3-month period in which the arithmetic 3-month Pb-
PM10 mean concentration equaled or exceeded 0.10
micrograms per cubic meter to install and begin operation of a Pb-
TSP sampler at the site.

0
22. Appendix D to Part 58 is amended by revising paragraph 4.5 to read
as follows:

Appendix D to Part 58--Network Design Criteria for Ambient Air Quality
Monitoring

* * * * *
    4.5 Lead (Pb) Design Criteria. (a) State and, where appropriate,
local agencies are required to conduct ambient air Pb monitoring
taking into account Pb sources which are expected to or have been
shown to contribute to a maximum Pb concentration in ambient air in
excess of the NAAQS, the potential for population exposure, and
logistics. At a minimum, there must be one source-oriented SLAMS
site located to measure the maximum Pb concentration in ambient air
resulting from each Pb source which emits 1.0 or more tons per year
based on either the most recent National Emission Inventory (http://
www.epa.gov/ttn/chief/eiinformation.html) or other scientifically
justifiable methods and data (such as improved emissions factors or
site-specific data) taking into account logistics and the potential
for population exposure.
    (i) One monitor may be used to meet the requirement in paragraph
4.5(a) for all sources involved when the location of the maximum Pb
concentration due to one Pb source is expected to also be impacted
by Pb emissions from a nearby source (or multiple sources). This
monitor must be sited, taking into account logistics and the
potential for population exposure, where the Pb concentration from
all sources combined is expected to be at its maximum.
    (ii) The Regional Administrator may waive the requirement in
paragraph 4.5(a) for monitoring near Pb sources if the State or,
where appropriate, local agency can demonstrate the Pb source will
not contribute to a maximum Pb concentration in ambient air in
excess of 50% of the NAAQS (based on historical monitoring data,
modeling, or other means). The waiver must be renewed once every 5
years as part of the network assessment required under 58.10(d).
    (b) State and, where appropriate, local agencies are required to
conduct Pb monitoring in each CBSA with a population equal to or
greater than 500,000 people as determined by the latest available
census figures. At a minimum, there must be one non-source-oriented
SLAMS site located to measure neighborhood scale Pb concentrations
in urban areas impacted by re-entrained dust from roadways, closed
industrial sources which previously were significant sources of Pb,
hazardous waste sites, construction and demolition projects, or
other fugitive dust sources of Pb.
    (c) The EPA Regional Administrator may require additional
monitoring beyond the minimum monitoring requirements contained in
4.5(a) and 4.5(b) where the likelihood of Pb air quality violations
is significant or where the emissions density, topography, or
population locations are complex and varied.
    (d) The most important spatial scales for source-oriented sites
to effectively characterize the emissions from point sources are
microscale and middle scale. The most important spatial scale for
non-source-oriented sites to characterize typical lead
concentrations in urban areas is the neighborhood scale. Monitor
siting should be conducted in accordance with 4.5(a)(i) with respect
to source-oriented sites.
    (1) Microscale--This scale would typify areas in close proximity
to lead point sources. Emissions from point sources such as primary
and secondary lead smelters, and primary copper smelters may under
fumigation conditions likewise result in high ground level
concentrations at the microscale. In the latter case, the microscale
would represent an area impacted by the plume with dimensions
extending up to approximately 100 meters. Pb monitors in areas where
the public has access, and particularly children have access, are
desirable because of the higher sensitivity of children to exposures
of elevated Pb concentrations.
    (2) Middle scale--This scale generally represents Pb air quality
levels in areas up to several city blocks in size with dimensions on
the order of approximately 100 meters to 500 meters. The middle
scale may for example, include schools and playgrounds in center
city areas which are close to major Pb point sources. Pb monitors in
such areas are desirable because of the higher sensitivity of
children to exposures of elevated Pb concentrations (reference 3 of
this appendix). Emissions from point sources frequently impact on
areas at which single sites may be located to measure concentrations
representing middle spatial scales.
    (3) Neighborhood scale--The neighborhood scale would
characterize air quality conditions throughout some relatively
uniform land use areas with dimensions in the 0.5 to 4.0 kilometer
range. Sites of this scale would provide monitoring data in areas
representing conditions where children live and play. Monitoring in
such areas is important since this segment of the population is more
susceptible to the effects of Pb. Where a neighborhood site is
located away from immediate Pb sources, the site may be very useful
in representing typical air quality values for a larger residential
area, and therefore suitable for population exposure and trends
analyses.
    (d) Technical guidance is found in references 4 and 5 of this
appendix. These documents provide additional guidance on locating
sites to meet specific urban area monitoring objectives and should
be used in locating new sites or evaluating the adequacy of existing
sites.
* * * * *

[FR Doc. E8-25654 Filed 11-10-08; 8:45 am]

BILLING CODE 6560-50-P


[Federal Register Volume 81, Number 44 (Monday, March 7, 2016)]
[Notices]
[Pages 11804-11806]
[FR Doc No: 2016-04965]

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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2016-N-0668]

Mechanistic Oral Absorption Modeling and Simulation for
Formulation Development and Bioequivalence Evaluation; Public Workshop;
Request for Comments

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice of public workshop; request for comments.

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SUMMARY: The Food and Drug Administration (FDA or the Agency) is

announcing a public workshop entitled ``Mechanistic Oral Absorption
Modeling and Simulation for Formulation Development and Bioequivalence
Evaluation.'' The purposes of the workshop are to share current FDA
experiences on the application of mechanism-based absorption modeling
and simulation in regulatory activities; discuss current and future
utility of mechanism-based absorption modeling and simulation in the
development of bioequivalent oral drug products and regulatory reviews;
obtain input from various stakeholders on when, where, and how to
conduct mechanism-based absorption modeling and simulations in the
context of bioequivalent product development; and request comments on
these topics.

DATES: The public workshop will be held on May 19, 2016, from 8:30 a.m.
to 4:30 p.m. Individuals who wish to attend the workshop must register
by April 19, 2016. The deadline for submitting either electronic or
written comments on this workshop is June 20, 2016. See the
SUPPLEMENTARY INFORMATION section for registration date and
information.

ADDRESSES: The public workshop will be held at FDA White Oak Campus,
10903 New Hampshire Ave., Bldg. 31 Conference Center, the Great Room
(Rm. 1503A), Silver Spring, MD 20993-0002. Entrance for the public
workshop participants (non-FDA employees) is through Building 1, where
routine security check procedures will be performed. For parking and
security information, please refer to http://www.fda.gov/AboutFDA/WorkingatFDA/BuildingsandFacilities/WhiteOakCampusInformation/ucm241740.htm.
    You may submit comments as follows:

Electronic Submissions

    Submit electronic comments in the following way:
     Federal eRulemaking Portal: http://www.regulations.gov.
Follow the instructions for submitting comments. Comments submitted
electronically, including attachments, to http://www.regulations.gov
will be posted to the docket unchanged. Since your comment will be made
public, you are solely responsible for ensuring that your comment does
not include any confidential information that you or a third party may
not wish to be posted, such as medical information, your or anyone
else's Social Security number, or confidential business information,
such as a manufacturing process. Please note that if you include your
name, contact information, or other information that identifies you in
the body of your comments, that information will be posted on http://www.regulations.gov.
     If you want to submit a comment with confidential
information that you do not wish to be made available to the public,
submit the comment as a written/paper submission and in the manner
detailed (see ``Written/Paper Submissions'' and ``Instructions'').

Written/Paper Submissions

    Submit written/paper submissions as follows:
     Mail/Hand delivery/Courier (for written/paper
submissions): Division of Dockets Management (HFA-305), Food and Drug
Administration, 5630 Fishers Lane, Rm. 1061, Rockville, MD 20852.
     For written/paper comments submitted to the Division of
Dockets Management, FDA will post your comment, as well as any
attachments, except for information submitted, marked and identified,
as confidential, if submitted as detailed in ``Instructions.''
    Instructions: All submissions received must include the Docket No.
FDA-2016-N-0668 for ``Mechanistic Oral Absorption Modeling and
Simulation for Formulation Development and Bioequivalence Evaluation;
Public Workshop; Request for Comments.'' Received comments will be
placed in the docket and, except for those submitted as ``Confidential
Submissions,'' publicly viewable at http://www.regulations.gov or at
the Division of Dockets Management between 9 a.m. and 4 p.m., Monday
through Friday.
     Confidential Submissions--To submit a comment with
confidential information that you do not wish to be made publicly
available, submit your comments only as a written/paper submission. You
should submit two copies total. One copy will include the information
you claim to be confidential with a heading or cover note that states
``THIS DOCUMENT CONTAINS CONFIDENTIAL INFORMATION.'' The Agency will
review this copy, including the claimed confidential information, in
its consideration of comments. The second copy, which will have the
claimed confidential information redacted/blacked out, will be
available for public viewing and posted on http://www.regulations.gov.
Submit both copies to the Division of Dockets Management. If you do not
wish your name and contact information to be made publicly available,
you can provide this information on the cover sheet and not in the body
of your comments and you must identify this information as
``confidential.'' Any information marked as ``confidential'' will not
be disclosed except in accordance with 21 CFR 10.20 and other
applicable disclosure law. For more information about FDA's posting of
comments to public dockets, see 80 FR 56469, September 18, 2015, or
access the information at: http://www.fda.gov/regulatoryinformation/dockets/default.htm.
    Docket: For access to the docket to read background documents or
the electronic and written/paper comments received, go to http://www.regulations.gov and insert the docket number, found in brackets in
the heading of this document, into the ``Search'' box and follow the
prompts and/or go to the Division of Dockets Management, 5630 Fishers
Lane, Rm. 1061, Rockville, MD 20852.

FOR FURTHER INFORMATION CONTACT: Xinyuan Zhang, Center for Drug
Evaluation and Research, Food and Drug Administration, 10903 New
Hampshire Ave., Bldg. 75, Rm. 4612, Silver Spring, MD 20993, 240-402-
7971, email<EMAIL_ADDRESS>or Liang Zhao, Center for Drug
Evaluation and Research, Food and Drug Administration, 10903 New
Hampshire Ave., Bldg. 75, Rm. 4606, Silver Spring, MD 20993, 240-402-
4468, email<EMAIL_ADDRESS>
SUPPLEMENTARY INFORMATION:

I. Background

    In July 2012, Congress passed the Generic Drug User Fee Amendments
(GDUFA) (Title III of the Food and Drug Administration Safety and
Innovation Act (Pub. L. 112-144)). GDUFA is designed to enhance public
access to safe, high-quality generic drugs and reduce costs to
industry. To support this goal, FDA agreed in the GDUFA commitment
letter to work with industry and interested stakeholders on identifying
regulatory science research priorities specific to generic drugs for
each fiscal year covered by GDUFA. The commitment letter outlines FDA's
performance goals and procedures under the GDUFA program for the years
2012 to 2017. The commitment letter can be found at http://www.fda.gov/downloads/ForIndustry/UserFees/GenericDrugUserFees/UCM282505.pdf.
    In the Regulatory Science section of the GDUFA Commitment Letter,
FDA outlined its plans to advance regulatory science, including with
respect to modeling and simulation. To enhance communication of recent
advances in modeling and simulation, including those supported by GDUFA
funds, FDA plans to hold a public workshop on

mechanistic oral absorption modeling and simulation. Mechanism-based
absorption modeling and simulation is a computational tool that
integrates drug substance information, drug product information, drug
product in vitro performance, and physiological properties of the human
body to predict drug product pharmacokinetics in vivo. Modeling
simulation studies may also, in principle, be used as a tool to
elucidate dissolution boundaries that have high likelihood of remaining
bioequivalence, and those boundaries can be used to inform clinically
relevant dissolution specifications. Models developed in a mechanistic
manner integrating all available knowledge relevant to the absorption
process lend great value for development of bioequivalent oral drug
products and regulatory evaluation because the main differences between
the reference drug products and the bioequivalent products (e.g., the
difference in formulation factors) are taken into account in the model.

II. Purpose and Scope of the Workshop

    The purpose of the workshop is to:
    1. Share FDA's current experiences on the application of mechanism-
based absorption modeling and simulation in regulatory activities;
    2. Discuss the current and future utility of mechanism-based
absorption modeling and simulation in development of bioequivalent oral
drug products and regulatory reviews; and
    3. Obtain input from the public on when, where, and how mechanism-
based absorption modeling and simulation should be applied in
development of bioequivalent oral drug products and review of
bioequivalence.
    The scope of the workshop covers the current status of mechanism-
based absorption modeling and simulation from academia, industry, and
regulatory perspectives.
    The majority of drug products on the market are administered
orally. Predicting oral bioavailability is always of great interest for
pharmaceutical scientists. It has been a long journey for scientists to
develop mechanistic absorption models for oral bioavailability
prediction to reduce drug development time and cost, and to inform
regulatory decisions. From simpler models to more complex ones,
mechanism-based absorption models have been advanced substantially and
their applications have been increasingly found in scientific
literature and regulatory reports.
    The high value of leveraging mechanistic absorption models in the
development and evaluation of bioequivalent drug products can be
attributed to their incorporation of formulation factors. The focus of
this public workshop is on the application of mechanistic absorption
modeling and simulation for development of bioequivalent oral drug
products and evaluation of bioequivalence, including discussing the
areas in which mechanistic oral absorption models can contribute
significantly, how the mechanistic absorption modeling and simulation
should be conducted and evaluated, and inherent scientific challenges.
    Public input will improve FDA's current understanding of using
mechanism-based absorption modeling and simulation in bioequivalence
evaluation. The knowledge gained from, and consensus reached, through
this workshop will be summarized and disseminated to the scientific
community by publication(s).

III. Scope of Public Input Requested

    FDA seeks input from the public on when, where, and how to utilize
mechanism-based absorption modeling and simulation in the context of
development of bioequivalent oral drug products and regulatory
evaluation of bioequivalence. Specific topics to be addressed include:
    1. Identifying the areas in which mechanistic oral absorption
models can contribute significantly during development of bioequivalent
oral drug products and regulatory evaluation of bioequivalence;
    2. How mechanistic absorption modeling and simulation should be
conducted and evaluated; and
    3. The scientific challenges in mechanistic oral absorption and
simulation.
    Registration and Requests for Attendee Participation: The FDA
Conference Center at the White Oak Campus is a Federal facility with
security screening and limited seating. Individuals who wish to attend
the public workshop (either in person or by Webcast (see Streaming
Webcast of the Public Workshop)) must register on or before April 19,
2016, by sending a request to<EMAIL_ADDRESS>with their
complete contact information (i.e., name, title, affiliation, address,
email address, and telephone number).
    There is no registration fee for the public workshop. Early
registration is recommended because seating is limited. Registration on
the day of the public workshop will be provided on a space available
basis beginning at 8 a.m.
    If you need special accommodations due to a disability, please
contact Xinyuan Zhang (see FOR FURTHER INFORMATION CONTACT) at least 7
days in advance.
    The workshop agenda and other background materials will be
available approximately 2 weeks before the workshop at http://www.fda.gov/Drugs/NewsEvents/ucm488178.htm. The agenda will include
time for questions and answers throughout the day and for general
comments and questions from the audience following panel discussions.
    In this document, FDA has included specific issues that will be
addressed by the panel. If you wish to address one or more of these
issues, please submit your comments via the Docket or speak during the
public comments session at the workshop. If you wish to speak during
the public comments session at the workshop, please indicate it at the
time you register so that FDA can consider that in planning the agenda.
FDA will do its best to accommodate requests to speak.
    Streaming Webcast of the Public Workshop: A live Webcast of this
workshop will be viewable at https://collaboration.fda.gov/r6gjahu3ejv
on the day of the workshop. The live Webcast will be in a listening
only mode.
    Transcripts: Transcripts of the workshop will be available for
review at http://www.fda.gov/Drugs/NewsEvents/ucm488178.htm at the
Division of Dockets Management (see ADDRESSES), and at http://www.regulations.gov approximately 30 days after the workshop. A
transcript will also be available, in either hardcopy or on CD-ROM,
after submission of a Freedom of Information request. The Freedom of
Information office address is available on the Agency's Web site at
http://www.fda.gov.

    Dated: March 1, 2016.
Leslie Kux,
Associate Commissioner for Policy.
[FR Doc. 2016-04965 Filed 3-4-16; 8:45 am]
BILLING CODE 4164-01-P


[Federal Register Volume 87, Number 81 (Wednesday, April 27, 2022)]
[Proposed Rules]
[Pages 24905-24908]
[FR Doc No: 2022-08890]

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DEPARTMENT OF TRANSPORTATION

Federal Aviation Administration

14 CFR Part 71

[Docket No. FAA-2022-0436; Airspace Docket No. 22-ASW-1]
RIN 2120-AA66

Proposed Amendment and Establishment of Air Traffic Service (ATS)
Routes; South Central United States

AGENCY: Federal Aviation Administration (FAA), DOT.

ACTION: Notice of proposed rulemaking (NPRM).

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SUMMARY: This action proposes to amend VHF Omnidirectional Range (VOR)
Federal airways V-198, V-212, V-556, and V-558; amend Area Navigation
(RNAV) route T-256; and establish RNAV route T-466. The FAA is
proposing this action due to the planned decommissioning of the VOR
portion of the Eagle Lake, TX (ELA), VOR/Distance Measuring Equipment
(VOR/DME) navigational aid (NAVAID). The Eagle Lake VOR is being
decommissioned in support of the FAA's VOR Minimum Operational Network
(MON) program.

DATES: Comments must be received on or before June 13, 2022.

ADDRESSES: Send comments on this proposal to the U.S. Department of
Transportation, Docket Operations, 1200 New Jersey Avenue SE, West
Building Ground Floor, Room W12-140, Washington, DC 20590; telephone:
1(800) 647-5527, or<PHONE_NUMBER>. You must identify FAA Docket No.
FAA-2022-0436; Airspace Docket No. 22-ASW-1 at the beginning of your
comments. You may also submit comments through the internet at https://www.regulations.gov.
    FAA Order JO 7400.11F, Airspace Designations and Reporting Points,
and subsequent amendments can be viewed online at https://www.faa.gov/air_traffic/publications/. For further information, you can contact the
Rules and Regulations Group, Federal Aviation Administration, 800
Independence Avenue SW, Washington, DC 20591; telephone: (202) 267-
8783.

FOR FURTHER INFORMATION CONTACT: Colby Abbott, Rules and Regulations
Group, Office of Policy, Federal Aviation Administration, 800
Independence Avenue SW, Washington, DC 20591; telephone: (202) 267-
8783.

SUPPLEMENTARY INFORMATION:

Authority for This Rulemaking

    The FAA's authority to issue rules regarding aviation safety is
found in Title 49 of the United States Code. 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. This rulemaking is promulgated under the authority
described in Subtitle VII, Part A, Subpart I, Section 40103. Under that
section, the FAA is charged with prescribing regulations to assign the
use of the airspace necessary to ensure the safety of aircraft and the
efficient use of airspace. This regulation is within the scope of that
authority as it would modify the National Airspace System (NAS) as
necessary to preserve the safe and efficient flow of air traffic.

Comments Invited

    Interested parties are invited to participate in this proposed
rulemaking by submitting such written data, views, or arguments as they
may desire. Comments that provide the factual basis supporting the
views and suggestions presented are particularly helpful in developing
reasoned regulatory decisions on the proposal. Comments are
specifically invited on the overall regulatory, aeronautical, economic,
environmental, and energy-related aspects of the proposal.
    Communications should identify both docket numbers (FAA Docket No.
FAA-2022-0436; Airspace Docket No. 22-ASW-1) and be submitted in
triplicate to the Docket Management Facility (see ADDRESSES section for
address and phone number). You may also submit comments through the
internet at https://www.regulations.gov.
    Commenters wishing the FAA to acknowledge receipt of their comments
on this action must submit with those comments a self-addressed,
stamped postcard on which the following statement is made: ``Comments
to FAA Docket No. FAA-2022-0436; Airspace Docket No. 22-ASW-1.'' The
postcard will be date/time stamped and returned to the commenter.
    All communications received on or before the specified comment
closing date will be considered before taking action on the proposed
rule. The proposal contained in this action may be changed in light of
comments received. All comments submitted will be available for
examination in the public docket both before and after the comment
closing date. A report summarizing each substantive public contact with
FAA personnel concerned with this rulemaking will be filed in the
docket.

Availability of NPRMs

    An electronic copy of this document may be downloaded through the
internet at https://www.regulations.gov. Recently published rulemaking
documents can also be accessed through the FAA's web page at https://www.faa.gov/air_traffic/publications/airspace_amendments/.
    You may review the public docket containing the proposal, any
comments received and any final disposition in person in the Dockets
Office (see ADDRESSES section for address and phone number) between
9:00 a.m. and 5:00 p.m., Monday through Friday, except federal
holidays. An informal docket may also be examined during normal
business hours at the office of the Operations Support Group, Central
Service Center, Federal Aviation Administration, 10101 Hillwood
Parkway, Fort Worth, TX 76177.

Availability and Summary of Documents for Incorporation by Reference

    This document proposes to amend FAA Order JO 7400.11F, Airspace
Designations and Reporting Points, dated August 10, 2021, and effective
September 15, 2021. FAA Order JO 7400.11F is publicly available as
listed in the ADDRESSES section of this document. FAA Order JO 7400.11F
lists Class A, B, C, D, and E airspace areas, air traffic service
routes, and reporting points.

Background

    The FAA is planning to decommission the Eagle Lake, TX, VOR in
December 2022. The Eagle Lake VOR was one of the candidate VORs
identified for discontinuance by the FAA's VOR MON program and listed
in the Final policy statement notice, ``Provision of Navigation
Services for the Next Generation Air Transportation System (NextGen)
Transition to Performance-Based Navigation (PBN) (Plan for Establishing
a VOR Minimum Operational Network),'' published in the Federal Register
of July 26, 2016 (81 FR 48694), Docket No. FAA-2011-1082.
    Although the VOR portion of the Eagle Lake VOR/DME is planned for
decommissioning, the co-located DME portion of the NAVAID is being
retained to support NextGen PBN flight procedure requirements.
    The ATS routes effected by the Eagle Lake VOR decommissioning are
VOR Federal airways V-198, V-212, V-556, and V-558, and RNAV route T-
256. The V-198, V-556, V-558, and T-256 ATS routes are affected
directly with the Eagle Lake VOR being included in the route
descriptions. Whereas, V-212 is affected based on the navigational
guidance the Eagle Lake VOR provides to a segment of the airway between
the extended service volume limit of the San Antonio, TX, VOR/Tactical
Air Navigation (VORTAC) NAVAID (SEEDS fix) and the intersection of the
San Antonio VORTAC and the Industry, TX, VORTAC radials (WEMAR fix).
Except for T-256, the planned decommissioning of the Eagle Lake VOR
results in the remaining ground-based NAVAID coverage in the area being
insufficient to enable the continuity of the affected ATS routes. As
such, modifications to V-198 and V-556 would result in creating or
extending gaps in the airways and modifications to V-212 and V-558
would result in the airways being shortened. And, modifications to T-
256 would include the Eagle Lake VOR/DME route point being removed from
the route description.
    To overcome the affected ATS route gaps or removed segments,
instrument flight rules (IFR) traffic could use portions of adjacent
VOR Federal airways V-68 and V-222 to circumnavigate the affected area,
or receive air traffic control (ATC) radar vectors to fly through the
affected area. Additionally, IFR pilots equipped with RNAV capabilities
could use T-200, T-220, and T-256, and the new T-466 proposed in this
action, or navigate point to point using the existing fixes that would
remain in place to support continued operations though the affected
area. Visual flight rules (VFR) pilots who elect to navigate via the
affected ATS routes could also take advantage of the adjacent ATS
routes or ATC services listed previously.
    Further, the FAA proposes to establish RNAV route T-466 between the
San Angelo, TX, VORTAC and Sabine Pass, TX, VOR/DME. The proposed T-
route would overlay the existing V-556 and, in part, mitigate the
proposed removal of the V-556 segment between the Stonewall, TX, VORTAC
and the Scholes, TX, VOR/DME. The new T-route would provide airspace
users equipped with RNAV capabilities an enroute structure between the
San Angelo, TX, area southeastward to the Galveston, TX, area and then
northeastward to the Beaumont, TX, area, by transiting north of the San
Antonio, TX, and New Braunfels, TX, areas and south of the Houston, TX,
area. Lastly, the new T-route would support the FAA's NextGen efforts
to modernize the NAS navigation system from a ground-based system to a
satellite-based system.

The Proposal

    The FAA is proposing an amendment to 14 CFR part 71 to amend VOR
Federal airways V-198, V-212, V-556, and V-558; amend RNAV route T-256;
and establish RNAV route T-466 due to the planned decommissioning of
the

Eagle Lake, TX, VOR. The proposed ATS route actions are described
below.
    V-198: V-198 currently extends between the San Simon, AZ, VORTAC
and the Eagle Lake, TX, VOR/DME; and between the Sabine Pass, TX, VOR/
DME and the Craig, FL, VORTAC. The FAA proposes to remove the route
segment between the San Antonio, TX, VORTAC and the Eagle Lake, TX,
VOR/DME. The unaffected portions of the existing airway would remain as
charted.
    V-212: V-212 currently extends between the San Antonio, TX, VORTAC
and the Mc Comb, MS, VORTAC. The FAA proposes to remove the airway
segment between the San Antonio, TX, VORTAC and the Industry, TX,
VORTAC. The unaffected portions of the existing airway would remain as
charted.
    V-556: V-556 currently extends between the San Angelo, TX, VORTAC
and the Sabine Pass, TX, VOR/DME. The FAA proposes to remove the airway
segment between the Stonewall, TX, VORTAC and the Scholes, TX, VOR/DME.
The unaffected portions of the existing airway would remain as charted.
    V-558: V-558 currently extends between the Llano, TX, VORTAC and
the Eagle Lake, TX, VOR/DME. The FAA proposes to remove the airway
segment between the Industry, TX, VORTAC and the Eagle Lake, TX, VOR/
DME. The unaffected portions of the existing airway would remain as
charted.
    T-256: T-256 currently extends between the San Antonio, TX, VORTAC
and the Sabine, TX, VOR/DME. The FAA proposes to remove the Eagle Lake,
TX, VOR/DME route point from the description as it is on a straight
segment of the route and does not change the route structure between
the San Antonio, TX, VORTAC and the MOLLR, TX, waypoint (WP).
Additionally, the FAA proposes to add a RNAV route segment overlaying
V-194 between the Sabine, TX, VOR/DME and the DAFLY, LA, WP being
established near the Lafayette, LA, VORTAC. The full route legal
description is listed in ``The Proposed Amendment'' section, below.
    T-466: T-466 is a proposed new RNAV route that would extend between
the San Angelo, TX, VORTAC and the Sabine Pass, TX, VOR/DME. The T-
route would overlay the current V-556 and, in part, mitigate the
proposed removal of the V-556 segment between the Stonewall, TX, VORTAC
and the Scholes, TX, VOR/DME. The new route would provide RNAV routing
between the San Angelo, TX, area southeastward to the Galveston, TX,
area and then northeastward to the Beaumont, TX, area. The full route
legal description is listed in ``The Proposed Amendment'' section,
below.
    All NAVAID radials listed in the VOR Federal airway descriptions
below are unchanged and stated in True degrees.
    VOR Federal airways are published in paragraph 6010(a), and RNAV T-
routes are published in paragraph 6011 of FAA Order JO 7400.11F, dated
August 10, 2021, and effective September 15, 2021, which is
incorporated by reference in 14 CFR 71.1. The ATS routes listed in this
document would be published subsequently in FAA Order JO 7400.11.
    FAA Order JO 7400.11, Airspace Designations and Reporting Points,
is published yearly and effective on September 15.

Regulatory Notices and Analyses

    The FAA has determined that this proposed regulation only involves
an established body of technical regulations for which frequent and
routine amendments are necessary to keep them operationally current.
It, therefore: (1) Is not a ``significant regulatory action'' under
Executive Order 12866; (2) is not a ``significant rule'' under
Department of Transportation (DOT) Regulatory Policies and Procedures
(44 FR 11034; February 26, 1979); and (3) does not warrant preparation
of a regulatory evaluation as the anticipated impact is so minimal.
Since this is a routine matter that will only affect air traffic
procedures and air navigation, it is certified that this proposed rule,
when promulgated, will not have a significant economic impact on a
substantial number of small entities under the criteria of the
Regulatory Flexibility Act.

Environmental Review

    This proposal will be subject to an environmental analysis in
accordance with FAA Order 1050.1F, ``Environmental Impacts: Policies
and Procedures,'' prior to any FAA final regulatory action.

List of Subjects in 14 CFR Part 71

    Airspace, Incorporation by reference, Navigation (air).

The Proposed Amendment

    In consideration of the foregoing, the Federal Aviation
Administration proposes to amend 14 CFR part 71 as follows:

PART 71--DESIGNATION OF CLASS A, B, C, D, AND E AIRSPACE AREAS; AIR
TRAFFIC SERVICE ROUTES; AND REPORTING POINTS

0
1. The authority citation for 14 CFR part 71 continues to read as
follows:

    Authority:  49 U.S.C. 106(f), 106(g); 40103, 40113, 40120; E.O.
10854, 24 FR 9565, 3 CFR, 1959-1963 Comp., p. 389.

Sec.  71.1   [Amended]

0
2. The incorporation by reference in 14 CFR 71.1 of FAA Order JO
7400.11F, Airspace Designations and Reporting Points, dated August 10,
2021, and effective September 15, 2021, is amended as follows:

Paragraph 6010(a) Domestic VOR Federal Airways.

* * * * *

V-198 [Amended]

    From San Simon, AZ; Columbus, NM; El Paso, TX; 6 miles wide INT
El Paso 109[deg] and Hudspeth, TX, 287[deg] radials; 6 miles wide
Hudspeth; 29 miles, 38 miles 82 MSL INT Hudspeth 109[deg] and Fort
Stockton, TX, 284[deg] radials; 18 miles 82 MSL Fort Stockton; 20
miles, 116 miles 55 MSL Junction, TX; to San Antonio, TX. From
Sabine Pass, TX; White Lake, LA; Tibby, LA; Harvey, LA; 69 miles, 33
miles 25 MSL Brookley, AL; INT Brookley 056[deg] and Crestview, FL,
266[deg] radials; Crestview; Marianna, FL; Seminole, FL; Greenville,
FL; Taylor, FL; INT Taylor 093[deg] and Craig, FL, 287[deg] radials;
to Craig.
* * * * *

V-212 [Amended]

    From Industry, TX; Navasota, TX; INT Navasota 019[deg] and
Lufkin, TX, 250[deg] radials; Lufkin; Alexandria, LA; to Mc Comb,
MS.
* * * * *

V-556 [Amended]

    From San Angelo, TX; INT San Angelo 181[deg] and Junction, TX,
310[deg] radials; Junction; to Stonewall, TX. From Scholes, TX; to
Sabine Pass, TX.
* * * * *

V-558 [Amended]

    From Llano, TX; INT Llano 088[deg] and Centex, TX, 306[deg]
radials; Centex; to Industry, TX.
* * * * *

Paragraph 6011 United States Area Navigation Routes.

* * * * *

T-256 San Antonio, TX (SAT) to DAFLY, LA [Amended]
San Antonio, TX (SAT)           VORTAC             (Lat. 29[deg]38'38.51'' N, long. 098[deg]27'40.74'' W)
MOLLR, TX                       WP                 (Lat. 29[deg]39'20.23'' N, long. 095[deg]16'35.83'' W)
Sabine Pass, TX (SBI)           VOR/DME            (Lat. 29[deg]41'12.19'' N, long. 094[deg]02'16.72'' W)

DAFLY, LA                       WP                 (Lat. 30[deg]11'37.70'' N, long. 091[deg]59'33.94'' W)

* * * * *

T-466 San Angelo, TX (SJT) to Sabine Pass, TX (SBI) [New]
San Angelo, TX (SJT)            VORTAC             (Lat. 31[deg]22'29.84'' N, long. 100[deg]27'17.53'' W)
CHILD, TX                       WP                 (Lat. 31[deg]03'41.17'' N, long. 100[deg]27'40.62'' W)
Junction, TX (JCT)              VORTAC             (Lat. 30[deg]35'52.88'' N, long. 099[deg]49'02.93'' W)
BETTI, TX                       FIX                (Lat. 29[deg]57'54.97'' N, long. 098[deg]03'23.98'' W)
MARCS, TX                       FIX                (Lat. 29[deg]53'52.04'' N, long. 097[deg]51'40.70'' W)
SEEDS, TX                       FIX                (Lat. 29[deg]39'31.94'' N, long. 097[deg]14'58.66'' W)
LDRET, TX                       WP                 (Lat. 29[deg]39'44.93'' N, long. 096[deg]19'00.96'' W)
KEEDS, TX                       WP                 (Lat. 29[deg]21'59.49'' N, long. 095[deg]36'48.98'' W)
Scholes, TX (VUH)               VOR/DME            (Lat. 29[deg]16'09.60'' N, long. 094[deg]52'03.81'' W)
Sabine Pass, TX (SBI)           VOR/DME            (Lat. 29[deg]41'12.19'' N, long. 094[deg]02'16.72'' W)

    Issued in Washington, DC, on April 21, 2022.
Scott M. Rosenbloom,
Manager, Airspace Rules and Regulations.
[FR Doc. 2022-08890 Filed 4-26-22; 8:45 am]
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