                           SUPPORTING STATEMENT FOR
                 INFORMATION COLLECTION REQUEST NUMBER 1775.09
                  "HAZARDOUS REMEDIATION WASTE MANAGEMENT
                         REQUIREMENTS (HWIR-MEDIA)"

                                 December 2021

                               TABLE OF CONTENTS

1.  	IDENTIFICATION OF THE INFORMATION COLLECTION
      1(a)  	Title of the Information Collection	2
      1(b)  	Short Characterization	2

2.  	NEED FOR AND USE OF THE COLLECTION
      2(a)  	Need/Authority for the Collection	8
      2(b)  	Practical Utility/Users of the Data	11

3.  	NONDUPLICATION, CONSULTATIONS, AND OTHER
      COLLECTION CRITERIA
      3(a)  	Nonduplication	13
      3(b)  	Public Notice	14
      3(c)  	Consultations	14
      3(d)  	Effects of Less Frequent Collection	14
      3(e)  	General Guidelines	15
      3(f)  	Confidentiality	15
      3(g)  	Sensitive Questions	15

4. 	THE RESPONDENTS AND THE INFORMATION REQUESTED
      4(a)  	Respondent SIC/NAICS Codes	15
      4(b)  	Information Requested	16

5.  	THE INFORMATION COLLECTED -- AGENCY ACTIVITIES, COLLECTION
     	METHODOLOGY AND INFORMATION MANAGEMENT
      5(a)  	Agency Activities	30
      5(b)  	Collection Methodology and Management	35
      5(c)  	Small Entity Flexibility	35
      5(d)  	Collection Schedule	35

6.  	ESTIMATING THE HOUR AND COST BURDEN OF THE COLLECTION
      6(a)  	Estimating Respondent Hours	36
      6(b)  	Estimating Respondent Costs	36
      6(c)  	Estimating Agency Hour and Cost Burden	37
      6(d)	Estimating the Respondent Universe and Total Hour and Cost Burden	38
      6(e)  	Bottom Line Hour and Cost Burden	38
      6(f)  	Reasons for Change in Burden	44
      6(g)  	Reasons for Change in Burden	45
      6(h)  	Burden Statement	45

1.	IDENTIFICATION OF THE INFORMATION COLLECTION

      1(a)	Title of the Information Collection

      This Information Collection Request (ICR) is entitled "Hazardous Remediation Waste Management Requirements (HWIR-Media) (Renewal)," ICR Number 1775.09.

      1(b)	Short Characterization

      The Resource Conservation and Recovery Act of 1976 (RCRA), as amended, requires the U.S. Environmental Protection Agency (EPA) to establish a national regulatory program to ensure that hazardous wastes are managed in a manner protective of human health and the environment.  Under this program (known as the RCRA Subtitle C program), EPA regulates newly generated hazardous wastes, as well as hazardous remediation wastes (i.e., hazardous wastes managed during cleanup).

      To facilitate prompt and protective treatment, storage, and disposal of hazardous remediation wastes, EPA established three requirements for remediation waste management sites that are different from those for facilities managing newly generated hazardous waste:

 Performance standards for remediation waste management sites at 40 CFR 264.1(j) that replaced the detailed requirements in 40 CFR part 264, subparts B, C, and D (General Facility Standards, Preparedness and Prevention, and Contingency Plans and Emergency Procedures);

 A provision excluding remediation waste management sites from RCRA section 3004(u)'s requirements for facility-wide corrective action; and

 A new form of RCRA permit for treating, storing, and disposing of hazardous remediation wastes at 40 CFR part 270, subpart H.  The new permit, a Remedial Action Plan (RAP), streamlines the permitting process for remediation waste management sites to allow cleanups to take place more quickly.

In addition, EPA created a new kind of unit called a "staging pile" at 40 CFR 264.554 that allows more flexibility in storing remediation waste during cleanup.

      This ICR describes the requirements applicable to owners/operators of remediation waste management sites at 40 CFR 264.1(j) and part 270, subpart H, as well as the requirements for staging piles at 40 CFR 264.554.  It replaces the previously approved ICR on remediation waste management requirements.  Section 6 estimates the annual hour and cost burden to respondents and the Agency under these requirements, and discusses the reasons for the change in annual burden since the previously approved ICR.

2.	NEED FOR AND USE OF THE COLLECTION

      2(a)	Need/Authority for the Collection

      This section describes the need and authority for each type of information collection analyzed in this ICR.  All information collection requirements associated with the hazardous remediation waste management requirements were established under the authority of sections 3004 and 3005 of RCRA, as amended.  EPA believes these information collection requirements are necessary to balance streamlined regulation of remediation wastes with the Agency's responsibility to protect human health and the environment.

(1)	General Requirements for Hazardous Remediation Waste Management Sites

      Hazardous remediation waste management sites must comply with all parts of 40 CFR part 264 except subparts B, C, and D, and section 264.101.  In place of the requirements in subparts B, C, and D, however, they need to comply with performance standards based on the general requirement goals in these sections, which are codified at 40 CFR 264.1(j).

      Section 264.1(j)(1) requires owners/operators of hazardous waste remediation sites to obtain an EPA identification number by applying to the Administrator using EPA Form 8700-12.  This information collection is required by section 3010 of RCRA, and is needed to ensure consistent and coordinated identification of the site by EPA under RCRA and other regulatory programs.

      Section 264.1(j)(2) requires owners/operators of remediation waste management sites to obtain a detailed chemical and physical analysis of a representative sample of the waste that will be remediated.  At a minimum, the waste analysis must contain all the information which must be known to treat, store, or dispose of the waste in accordance with 40 CFR parts 264 and 268.  The owner/operator needs the information obtained from the waste analysis to determine whether there are any potential dangers from handling the remediation waste.  The waste analysis requirement contributes to EPA's goal of preventing undetected releases or reactions of hazardous waste on site.

      Section 264.1(j)(4) requires owners/operators to inspect the remediation waste management site for malfunctions, deterioration, operator errors, and discharges that may be causing, or may lead to, a release of hazardous waste constituents to the environment, or a threat to human health.  The owner/operator needs to conduct these inspections to identify problems in time to correct them before they harm human health or the environment.  EPA needs owners/operators to perform inspections in order to prevent undetected releases or other problems at the facility.

      Section 264.1(j)(7) requires owners/operators not to locate remediation waste management units within a floodplain unless the owner/operator can meet the demonstration of section 264.18(b).  In particular, the owner/operator must demonstrate that procedures will be in effect to remove waste safely before flood waters reach the unit in the event of a flood, or no adverse effects on human health or the environment would result from a washout.  This information collection contributes to EPA's goal of preventing unforseen releases of hazardous wastes.

      Section 264.1(j)(9) requires owners/operators to develop and maintain a construction quality assurance program for surface impoundments, waste piles, and landfills, as specified.  EPA needs this information to ensure that the units are constructed and designed to prevent unforseen releases of hazardous wastes.

      Section 264.1(j)(10) codifies streamlined contingency and emergency plan regulations for hazardous remediation waste sites.  Requiring remediation waste management sites to develop and maintain contingency and emergency plans contributes to EPA's goal of minimizing unanticipated damage from the treatment, storage, or disposal of hazardous waste.  Contingency planning is also mandated by RCRA section 3004(a)(5).

      Section 264.1(j)(12) requires owners/operators of remediation waste management sites to develop, maintain, and implement a plan to meet the requirements in sections 264.1(j)(2) through (j)(6) and sections 264.1(j)(9) through (j)(10).  40 CFR 264.1(j)(13) requires owners/operators of remediation waste management sites to maintain records documenting compliance with sections 264.1(j)(1) through (j)(12).  Under 40 CFR 264.73(b)(17), owners/operators of remediation waste management sites are required to record, as it becomes available, and maintain in the operating record any records required under section 264.1(j)(13).  EPA needs a record of this information to be sure that the requirements of section 264.1(j) are being met.

(2)	Requirements for Staging Piles

      Staging piles are codified at 40 CFR 264.554 under the authority of section 3004 of RCRA.  Sections 264.554(c) and (d) identify procedures and information requirements for designating staging piles.  Information provided to EPA by owners/operators seeking designation of staging piles is needed to ensure that the design and operation of the staging pile will comply with all applicable regulations and will be protective of human health and the environment.

      Owners/operators may request an extension of up to six months to the two-year limit for staging pile operation.  Extensions are authorized under section 264.554(i) and require a request with supporting information to be submitted to EPA.  EPA requires information in extension requests to ensure that continued operation of the staging pile is necessary and will not pose a threat to human health and the environment.  In addition, the information may be necessary to develop further standards and design criteria for the staging pile.

      Section 264.554(k) provides that, within 180 days after the operating term of the staging pile expires, owners/operators must close a staging pile located in an uncontaminated area of the site in accordance with sections 264.258(a) and 265.258(a) and sections 264.111 and 265.111 (i.e., the closure requirements for waste piles).

      Section 264.554(l) specifies procedures for incorporating staging piles into existing permits (including RAPs), closure plans, or orders, at the owner/operator's initiative.  These procedures are needed to keep the permit, closure plans, or orders up to date.

(3)	Remedial Action Plans

      Under 40 CFR 270.80 through 270.90, EPA provides general information on RAPs (e.g., a definition of a RAP, applicability criteria).  Under section 270.95 through 270.125, EPA describes how to apply for a RAP.  These procedures are needed to ensure owners/operators understand the requirements and procedures they must follow.

      Under section 270.130(b), if the Director tentatively finds that the RAP application does not include all of the information required under section 270.110 or that the proposed remediation waste management activities do not meet regulatory standards, the Director may request additional information from the owner/operator.  EPA needs this information to ensure that the proposed remediation waste management activities meet the regulatory standards.

      The Agency believes that the information collected in the RAP applications is necessary to determine how and where media and remediation waste will be managed.  The information is essential to determine whether the management of these materials will be protective of human health and the environment, and will be in compliance with standards established pursuant to RCRA.

      Under section 270.170, the Director must specify in a RAP, either directly or by reference, procedures for future modifications, revocations and reissuance, or termination of the RAP.  Owners/operators and EPA need these procedures to ensure that modifications can be made in a manner that protects human health and the environment.

      Under section 270.195, RAPs must be issued for a fixed term, not to exceed ten years, although they may be renewed upon approval by the Director in fixed increments of no more than ten years by following the requirements of section 270.200.  EPA needs this information to determine whether the management of these materials will be protective of human health and the environment, and will be in compliance with standards established pursuant to RCRA.

      Section 270.210 requires owners/operators of remediation waste management sites to keep records concerning their RAP.  Recordkeeping is required to ensure that owners/operators are following the requirements for preparing and maintaining a RAP.

      Under section 270.220, owners/operators of remediation waste management sites may transfer their RAPs to new owners/operators.  Records of such changes are needed to ensure that owners/operators are aware of their rights and obligations under part 270, subpart H.

      Under section 270.230, owners/operators may request a RAP for remediation waste management activities at a location removed from the area where the remediation wastes originated if they believe such a location would be more protective than the contaminated area or areas in close proximity.  This information is essential to determine whether the management of hazardous remediation waste will be protective of human health and the environment, and will be in compliance with standards established pursuant to RCRA.

      2(b)	Practical Utility/Users of the Data

(1)	General Requirements for Hazardous Remediation Waste Management Sites

      An owner/operator of a hazardous remediation waste management site must request an EPA identification number by completing and submitting EPA Form 8700-12, according to section 264.1(j)(1).  EPA uses Form 8700-12 to process the request and to ensure accurate and consistent identification of the site.  Both EPA and the owner/operator use the EPA identification number as a standard way of identifying the site (e.g., in correspondence, reports).

      In performing waste analysis, pursuant to section 264.1(j)(2), the owner/operator of a remediation waste management site obtains detailed chemical and physical properties of the remediation waste.  The owner/operator uses these data to design and implement effective and safe remedial actions and to prevent unanticipated contaminant releases.

      Section 264.1(j)(4) requires owners/operators to inspect the remediation waste management site for malfunctions, deterioration, operator errors, and discharges that may be causing, or may lead to, a release of hazardous waste constituents to the environment, or a threat to human health.  The owner/operator uses the data collected in order to identify problems in time to correct them before they harm human health or the environment.

      Under section 264.1(j)(7), owners/operators planning to design, construct, operate, or maintain a hazardous remediation waste management unit in a 100-year floodplain must demonstrate that the unit meets the criteria of section 264.18(b).  The Director uses the information in the demonstration to evaluate whether the risk of contamination due to a flood is greater if the wastes are left unremediated within the floodplain than if the remediation wastes are managed in a unit within the floodplain.

      Section 264.1(j)(9) requires owners/operators to develop and maintain a construction quality assurance program for surface impoundments, waste piles, and landfills, as specified.  Owners/operators use this plan to construct and maintain these units in a manner that prevents unforseen releases of hazardous wastes.

      Section 264.1(j)(10) requires owners/operators of remediation waste management sites to develop and maintain contingency and emergency plans.  The contingency and emergency plans are used by the owner/operator to assure an appropriate response to any unplanned release of hazardous waste or hazardous waste constituents during the remedial action.

      Section 264.1(j)(12) requires owners/operators of remediation waste management sites to develop, maintain, and implement a plan to meet the requirements in sections 264.1(j)(2) through (j)(6) and sections 264.1(j)(9) through (j)(10).  40 CFR 264.1(j)(13) requires owners/operators of remediation waste management sites to maintain records documenting compliance with sections 264.1(j)(1) through (j)(12).  Under 40 CFR 264.73(b)(17), owners/operators of remediation waste management sites are required to record, as it becomes available, and maintain in the operating record any records required under section 264.1(j)(13).  Owners/operators use these records to keep track of maintenance and repairs, inspections, design criteria, and compliance with other aspects of hazardous waste remediation.

(2)	Requirements for Staging Piles

      Data submitted by owners/operators seeking designation of staging piles is used by EPA to evaluate and approve proposed remedial actions involving staging piles.  Specifically, EPA uses the data to develop standards and design criteria for staging piles that are included in an approved permit, order, or closure plan.  Similarly, when owners/operators request extensions to the two-year limit for operating a staging pile, EPA uses submitted data to evaluate the need for and protectiveness of the extension, and to issue further standards and design criteria if needed.

      Owners/operators using a staging pile in uncontaminated areas must close the staging piles in accordance with applicable requirements of sections 264.258(a) and 264.111 or 265.258(a) and 265.111.  Information submitted by owners/operators pursuant to these closure and post-closure care requirements is used by EPA to approve closure plans and ensure that the site does not pose a continuing threat to human health and the environment.

      Section 264.554(l) specifies procedures for incorporating staging piles into existing RCRA permits, closure plans, or orders.  In processing the information collected, EPA ensures that the proposed modifications will comply with all applicable provisions of RCRA.

(3)	Remedial Action Plans

      Information submitted in RAP applications and renewals, including requested additional information, is used by the Director to verify that proposed remedial activities will be conducted in accordance with applicable regulations and in a manner which protects human health and the environment.  In addition, the Director may use the information in aggregate (e.g., number of RAPs approved) to track and evaluate RCRA implementation and to assist with further program development.

      Section 270.210 requires owners/operators to maintain a file of RAP-related documents.  The owners/operators use information included in the operating record to minimize unanticipated damage from the treatment, storage, or disposal of hazardous remediation waste.  If an unanticipated release occurs, the owner/operator may review the information in the file to determine the composition of the waste and appropriate contingency measures.

      In the event that a remediation waste management site changes ownership, a RAP may be transferred to the new owner/operator under the procedures in section 270.220.  Specifically, the current owner/operator is required to submit to the Director a modified RAP and a written agreement between the current and new owner/operator.  The Director uses this information to maintain accurate records on the ownership of the sites and to ensure that new owners/operators are aware of their rights and obligations under part 270, subpart H.

      Under section 270.230, owners/operators may request a RAP for remediation waste management activities at a location removed from the area where the remediation wastes originated if they believe such a location would be more protective than the contaminated area or areas in close proximity.  The Director uses the information to verify that proposed remedial activities will be conducted in accordance with applicable regulations in a manner that protects human health and the environment.

3.	NONDUPLICATION, CONSULTATIONS, AND OTHER COLLECTION CRITERIA

      3(a)	Nonduplication

      No document identical or similar in purpose to the RAP is required by the Federal government.  Since management of hazardous contaminated media will take place under many Federal and State remedial programs, the Agency has established RAP requirements that are flexible enough so that any enforceable document used by one of these programs, which contains the relevant information and goes through at least the minimum public participation requirements in section 270.145, can be considered equivalent to the RAP.  A respondent would not be required to duplicate effort or documentation to meet the requirements of the RAP.

      Most of the information required by the regulations is not available from any source but the respondents.  To avoid duplicating previous work, EPA allows respondents to draw upon similar analyses in compiling data (e.g., for waste analyses), provided the information meets the requirements specified in the regulations.

      3(b)	Public Notice

      In compliance with the Paperwork Reduction Act of 1995, EPA issued a public notice in the Federal Register on September 28, 2021 (86 FR 53656) and provided a 60-day comment period.  No comments were received.

      3(c)	Consultations

      EPA consulted with several State and Regional representatives to ascertain the number of respondents subject to the RAP requirements under 40 CFR part 270.

      3(d)	Effects of Less Frequent Collection

      EPA has carefully considered the burden imposed upon the regulated community by the general requirements for remediation waste management sites.  EPA is confident that those activities required of respondents are necessary, and to the extent possible, has attempted to minimize the burden imposed.  EPA believes strongly that if the minimum requirements specified under the regulations are not met, neither the facilities nor EPA can ensure that hazardous remediation wastes will be managed properly, and will not pose a serious threat to human health and the environment.

      Since the RAP is a one-time document for a particular remediation waste management site, less frequent preparation is not possible.  At some sites, periodic review or renewal of the RAP may be needed to assure that the remedy continues to comply with currently applicable RCRA requirements.  RAPs are for fixed terms, not to exceed ten years.  When remedies continue beyond the term of the RAP, the Director may renew the RAP unchanged or with changes as needed.  In addition, the Director must review RAPs for hazardous waste land disposal facilities every five years.  Although the RAP renewals and five-year reviews do not require owners/operators to submit progress reports or new applications, communication will be necessary to appraise the Director of the status of the cleanup.

      3(e)	General Guidelines

      This ICR adheres to the guidelines stated in the Paperwork Reduction Act of 1995 (PRA), OMB's implementing regulations, EPA's Information Collection Review Handbook, and other applicable OMB guidance.

      3(f)	Confidentiality

      Section 3007(b) of RCRA and 40 CFR part 2, subpart B, which define EPA's general policy on public disclosure of information, contain provisions for confidentiality.  In addition, under section 270.115, EPA has established procedures that owners/operators submitting RAPs may use to claim as confidential any or all of the information submitted as part of the application.  If such a claim were asserted, EPA must and will treat the information in accordance with the regulations above.  Finally, EPA has ensured that this information collection complies with the Privacy Act of 1974 and OMB Circular 108.

      3(g)	Sensitive Questions

      No questions of a sensitive nature are included in any of the information collection requirements.

4.	THE RESPONDENTS AND THE INFORMATION REQUESTED

      4(a)	Respondent SIC/NAICS Codes

      The following is a list of North American Industrial Classification System (NAICS) codes associated with facilities most likely affected by the information requirements covered in this ICR.

                                Industry Sector
                                 NAICS Code(s)
Wood Preservation
                                    321114
Alkalies and Chlorine Manufacturing
                                    325181
All Other Miscellaneous Chemical Product and Preparation Manufacturing
                                    325998
Plastics Material and Resin Manufacturing
                                    325211
All Other Basic Organic Chemical Manufacturing
                                    325199
Pesticide and Other Agricultural Chemical Manufacturing
                                     32532
Petroleum Refineries
                                     32411
Plastics and Rubber Products Manufacturing
                                      326
All Other Plastic Products Manufacturing
                                    326199
Other Pressed and Blown Glass and Glassware Manufacturing
                                    327212
Rolled Steel Shape Manufacturing
                                    331221
Nonferrous Metal (except Aluminum) Production and Processing
                                     3314
Secondary Smelting and Alloying of Aluminum
                                    331314
Fabricated Metal Product Manufacturing
                                      332
Small Arms Ammunition Manufacturing
                                    332992
Other Ordnance and Accessories Manufacturing
                                    332995
Mechanical Power Transmission Equipment Manufacturing
                                    333613
Communications Equipment Manufacturing
                                     3342
Semiconductors and Related Device Manufacturing
                                    334413
Storage Battery Manufacturing
                                    335911
Aerospace Product and Parts Manufacturing
                                     3364
Guided Missile and Space Vehicle Propulsion Unit and Propulsion Unit Parts Manufacturing
                                    336415
Travel Trailer and Camper Manufacturing
                                    336214
Navigational, Measuring, Electromedical, and Control Instruments Manufacturing
                                     3345
Surgical and Medical Instrument Manufacturing
                                    339112
Other Support Activities for Road Transportation
                                     48849
Support Activities for Air Transportation
                                     4881
Waste Treatment and Disposal
                                     5622
Dry Cleaning and Laundry Services
                                     8123
Colleges, Universities, and Professional Schools
                                     61131
National Security
                                     92811

      4(b)	Information Requested

(1)	General Requirements for Hazardous Remediation Waste Management Sites

      (a)	EPA Identification Number

      40 CFR 264.1(j)(1) requires owners/operators of remediation waste management sites to have EPA identification numbers.  An EPA identification number can be obtained by applying to the Administrator using EPA Form 8700-12.

      (i)	Data Item:

      The data item required of owners/operators includes:

 A completed EPA Form 8700-12.

      (ii)	Respondent Activities:

      In order to comply with the above requirements, owners/operators must conduct the following activities:

 Complete and submit EPA Form 8700-12.

      [Note:  This ICR does not address the requirement in 40 CFR 264.1(j)(1) for obtaining an EPA identification number.  Refer to OMB Control No. 2050-0024 for this requirement.]

      (b)	Waste Analyses

      40 CFR 264.1(j)(2) requires owners/operators of remediation waste management sites to obtain a detailed chemical and physical analysis of a representative sample of the hazardous remediation wastes to be managed at the site.  At a minimum, the waste analysis must contain all the information that must be known to treat, store or disposed of the waste in accordance with 40 CFR parts 264 and 268, and must be kept accurate and up to date.

      (i)	Data Item:

      The data item required of owners/operators includes:

 A detailed chemical and physical analysis of a representative sample of the hazardous remediation wastes to be managed at the site.

      (ii)	Respondent Activity:

      In order to comply with the above requirements, owners/operators must conduct the following activity:

 Perform waste analysis.

      (c)	Inspections

      40 CFR 264.1(j)(4) requires owners/operators to inspect the remediation waste management site for malfunctions, deterioration, operator errors, and discharges that may be causing, or may lead to, a release of hazardous waste constituents to the environment, or a threat to human health.  The owner/operator must conduct these inspections often enough to identify problems in time to correct them before they harm human health or the environment, and must remedy the problem before it leads to a human health or environmental hazard.  Where a hazard is imminent or has already occurred, the owner/operator must take remedial action immediately.

      (i)	Data Item:

      The data item required of owners/operators includes:

 An inspection record.

      (ii)	Respondent Activity:

      In order to comply with the above requirements, owners/operators must conduct the following activity:

 Conduct inspections.

      (d)	Demonstrations for Remediation Waste Management Sites in Floodplains

      Under 40 CFR 264.1(j)(7), owners/operators of remediation waste management sites subject to regulation under part 264, subparts I through O and subpart X must design, construct, operate, and maintain units within a 100-year floodplain to prevent washout of any hazardous waste by a 100-year flood, unless they can meet the demonstration requirements of section 264.18(b).

      (i)	Data Item:

      The data item required of owners/operators includes:

 A demonstration that establishes that procedures are in effect which will cause the waste to be removed safely, before flood waters can reach the facility, to a location where the wastes will not be vulnerable to flood waters.

      (ii)	Respondent Activity:

      In order to comply with the above requirements, owners/operators must conduct the following activity:

 Prepare and submit demonstration for exemption from design and operating standards under §264.18(b).

      (e)	Construction Quality Assurance Program

      40 CFR 264.1(j)(9) requires owners/operators to develop and maintain a construction quality assurance program for all surface impoundments, waste piles, and landfill units that are required to comply with sections 264.221(c) and (d), 264.251(c) and (d), and 264.301(c) and (d) at the remediation waste management site, according to the requirements of section 264.19.

      (i)	Data Item:

      The data item required of owners/operators includes:

 A construction quality assurance program.

      (ii)	Respondent Activities:

      In order to comply with the above requirements, owners/operators must conduct the following activities:

 Develop and maintain a construction quality assurance program.

      (f)	Contingency and Emergency Plan

      40 CFR 264.1(j)(10) requires owners/operators of remediation waste management sites to develop and maintain procedures to prevent accidents.  These procedures must address proper design, construction, maintenance, and operation of hazardous remediation waste management units at the site.

      In addition, owners/operators must develop and maintain a contingency and emergency plan to control accidents that occur.  The plan must explain specifically how to treat, store, and dispose of the hazardous remediation waste in question, and must be implemented immediately whenever fire, explosion, or release of hazardous waste or hazardous waste constituents that could threaten human health or the environment.

      (i)	Data Items:

      The data items required of owners/operators include:

 Procedures to prevent accidents; and
 A contingency and emergency plan.

      (ii)	Respondent Activities:

      In order to comply with the above requirements, owners/operators must conduct the following activities:

 Develop and maintain procedures to prevent accidents; and

 Develop and maintain contingency and emergency plan.

      (g)	Compliance Plan

      40 CFR 264.1(j)(12) requires owners/operators of remediation waste management sites to develop, maintain, and implement a plan to meet the requirements in sections 264.1(j)(2) through (j)(6) and sections 264.1(j)(9) through (j)(10).

      (i)	Data Item:

      The data item required of owners/operators includes:

 A compliance plan.

      (ii)	Respondent Activities:

      In order to comply with the above requirements, owners/operators must conduct the following activities:

 Develop, maintain, and implement a plan to meet the requirements in §§264.1(j)(2) through (j)(6) and §§264.1(j)(9) through (j)(10).

      (h)	Recordkeeping Requirements

      40 CFR 264.1(j)(13) requires owners/operators of remediation waste management sites to maintain records documenting compliance with sections 264.1(j)(1) through (j)(12).  These records must be maintained in the operating record as required under section 264.73(b)(17).

      (i)	Data Items:

      The data items required of owners/operators include:

 Records documenting compliance with §§264.1(j)(1) through (j)(12).

      (ii)	Respondent Activity:

      In order to comply with the above requirements, owners/operators must conduct the following activity:

 Keep records documenting compliance with §§264.1(j)(1) through (j)(12).

(2)	Requirements for Staging Piles

      (a)	Designation of Staging Piles

      Under 40 CFR 264.554(c)(1), owners/operators seeking staging pile designations must provide sufficient and accurate information to enable the Director to impose standards and design criteria for the staging pile.  In addition, under section 264.554(c)(2), the owner/operator must provide a certification by an independent, qualified, registered professional engineer for technical data (e.g., design drawings and specifications, engineering studies), unless the Director determines, based on information provided by the owner/operator, that the certification is not necessary to ensure that the staging pile will protect human health and the environment.  Finally, under section 264.554(c)(3), the owner/operator must provide any additional information the Director determines is necessary to protect human health and the environment.

      (i)	Data Items:

      The data items required of owners/operators include:

 Information that will enable the Director to impose standards and design criteria for the staging pile;
 Certification by an independent, qualified, registered professional engineer for technical data; and
 Any additional information requested by the Director.

      (ii)	Respondent Activities:

      In order to comply with the above requirements, owners/operators must conduct the following activities:

 Prepare information that will enable the Director to impose standards and design criteria for the staging pile;
 Obtain certification by an independent, qualified, registered professional engineer for technical data, unless the Director determines that the certification is not necessary;
 Submit information to the Director; and
 Prepare and submit additional information requested by the Director, if requested.

      (b)	Staging Pile Recordkeeping

      As provided under 40 CFR 264.554(d)(1)(iii), a staging pile must not operate for more than two years, except when the Director grants an operating term extension under section 264.554(i).  The owner/operator must measure the two-year limit, or other operating term specified by the Director in the permit, closure plan, or order, from the first time remediation waste is placed into the staging pile.  The owner/operator must maintain a record of the date when remediation waste was first placed into the staging pile for the life of the permit, order, or approved closure plan, or for three years, whichever is longer.

      (i)	Data Item:

      The data item required of owners/operators includes:

 A record of the date when the remediation waste was first placed into the staging pile.

      (ii)	Respondent Activities:

      In order to comply with the above requirements, owners/operators must conduct the following activities:

 Record the date of waste placement in the unit; and
 File the record.

      (c)	Staging Pile Extensions

      Under 40 CFR 264.554(i)(1), the Director may grant one operating term extension for a staging pile of up to 180 days beyond the operating term limit contained in the permit, closure plan, or order.  To obtain an extension, owners/operators must document that an extension will not pose a threat to human health and the environment and is necessary to ensure timely and efficient implementation of remedial actions at the facility.

      (i)	Data Item:

      The data item required of owners/operators includes:

 Information documenting that an extension: (1) will not pose a threat to human health and the environment and (2) is necessary to ensure timely and efficient implementation of remedial actions at the facility.

      (ii)	Respondent Activities:

      In order to comply with the above requirements, owners/operators must conduct the following activities:

 Prepare documentation supporting an extension; and
 Submit request for extension.

      (d)	Closure of Staging Piles

      40 CFR 264.554(k) provides that, within 180 days after the operating term of the staging pile expires, owners/operators must close a staging pile located in an uncontaminated area of the site in accordance with sections 264.258(a) and 265.258(a) and sections 264.111 and 265.111 (i.e., the closure requirements for waste piles).  [Note: This ICR does not address the requirements in 40 CFR 264.258(a), 265.258(a), 264.111, and 265.111 for closing a staging pile.  Refer to OMB Control No. 2050-0120 for these requirements.]

      (e)	Incorporation of Staging Piles into Existing Permits

      40 CFR 264.554(l) specifies procedures for incorporating staging piles into existing permits (including RAPs), closure plans, or orders.  Pursuant to section 264.554(l)(1), a permit, other than a RAP, may be modified to incorporate a staging pile or staging pile operating term extension as part of an Agency-initiated permit modification under section 270.41or as part of an owner/operator initiated Class 2 permit modification under section 270.42.  [Note:  This ICR does not address the requirements in 40 CFR 270.41 and 270.42 for modifying an existing RCRA permit.  Refer to OMB Control No. 2050-0009 for these requirements.]

      Pursuant to section 264.554(l)(2), an owner/operator may modify an existing RAP to incorporate a staging pile or staging pile operating term extension by complying with the RAP modification requirements under sections 270.170 and 270.175.

      Pursuant to section 265.554(l)(3), an owner/operator may modify an existing closure plan to incorporate a staging pile or staging pile operating term extension by following the applicable requirements under section 264.112(c) or 265.112(c).  [Note:  This ICR does not address the requirements in 40 CFR 264.112(c) or 265.112(c) for modifying an existing closure plan.  Refer to OMB Control No. 2050-0009, for the requirements under section 264.112(c).  Refer to EPA OMB Control No. 2050-0120 for the requirements under section 265.112(c).]

      Pursuant to section 264.554(l)(4), an owner/operator may modify an existing order to incorporate a staging pile or staging pile operating term extension by following the terms of the order and the applicable provisions of section 270.72(a)(5) or 270.72(b)(5).  [Note: Facilities incorporating staging piles into their orders would not follow the requirements in this ICR.  Rather, they would follow the procedures spelled out in their site-specific order.  As such, these facilities are not addressed in this ICR.]

(3)	Remedial Action Plans

      (a)	RAP Application

      40 CFR 270.80(a) defines a RAP as a special form of RCRA permit that an owner/operator of a remediation waste management site may obtain, instead of a permit issued under sections 270.3 through 270.66, to treat, store, or dispose of hazardous remediation waste at a remediation waste management site.

      Under 40 CFR 270.85(a), whenever an owner/operator treats, stores, or disposes of hazardous remediation waste in a manner that requires a RCRA permit under section 270.1, the owner/operator must either obtain a RCRA permit or a RAP.

      Under 40 CFR 270.85(c), an owner/operator may obtain a RAP for managing hazardous remediation waste at an already permitted RCRA facility.  This RAP must be approved as a modification to the existing permit according to the requirements of section 270.41 or section 270.42.  However, when the owner/operator submits an application for such modification, the information requirements in section 270.42(a)(1)(i), (b)(1)(iv), and (c)(1)(iv) do not apply; instead, the owner/operator must submit the information required under section 270.110.  When the permit is modified, the RAP becomes part of the RCRA permit.  [Note:  This ICR does not address the requirements in 40 CFR 270.41 and 270.42 for modifying an existing RCRA permit.  Refer to OMB Control No. 2050-0009 for these requirements.]

      Under 40 CFR 270.95, an owner/operator may apply for a RAP by completing an application, signing it, and submitting it to the Director.

      40 CFR 270.100 provides that, when a facility or remediation waste management site is owned by one person, but the treatment, storage, or disposal activities are operated by another person, it is the operator's duty to obtain a RAP.  Under section 270.105, both the owner and the operator must sign the RAP application and any required reports according to sections 270.11(a) through (c).  In addition, both the owner and the operator must also make the certification required under section 270.11(d)(1).  However, the owner may choose the alternative certification under section 270.11(d)(2) if the operator certifies under section 270.11(d)(1).

      The RAP application must include all the information specified in section 270.110.  Under section 270.115, an owner/operator may claim as confidential any or all of the information he submits to EPA.  Any such claim must be asserted at the time he submits his RAP application or other submissions by stamping the words "confidential business information" on each page containing such information.

      The owner/operator must submit the RAP application to the Director for approval (§270.120).  If the RAP application is submitted as part of another document, he must clearly identify the components of that document that constitute the RAP application (§270.125).

      40 CFR 270.130(b) provides that, if the Director tentatively finds that a RAP application does not include all of the information requested in section 270.110 or that the proposed remediation waste management activities do not meet the regulatory standards, the Director may request additional information from the owner/operator or ask the owner/operator to correct deficiencies in his application.

      (i)	Data Item:

      The data item required of owners/operators includes a RAP application with the following information:

 Owner and operator signatures in accordance with §270.11(a) through (c);
 Owner and operator certifications required under §270.11(d);
 Information specified in §270.110:
            --	The name, address, and EPA identification number of the remediation waste management site;
            --	The name, address, and telephone number of the owner and operator;
            --	The latitude and longitude of the site;
            --	The U.S. Geological Survey or county map showing the location of the remediation waste management site;
            --	A scaled drawing of the remediation waste management site showing:
 The remediation waste management site boundaries;
 Any significant physical structures;
 The boundary of all areas on site where remediation waste is to be treated, stored, or disposed;
            --	A specification of the hazardous remediation waste to be treated, stored, or disposed of at the facility or remediation waste management site, including the following information:
 Constituent concentrations and other properties of the hazardous remediation wastes that may affect how such materials should be treated and/or otherwise managed;
 An estimate of the quantity of these wastes;
 A description of the processes that will be used to treat, store, or dispose of the waste including technologies, handling systems, design, and operating parameters that will be used to treat hazardous remediation wastes before disposing of them according to the land disposal restrictions standards of part 268, as applicable;
            --	Enough information to demonstrate that operations that follow the provision in the RAP application will ensure compliance with applicable requirements of parts 264, 266, and 268;
            --	Such information as may be necessary to enable the Regional Administrator to carry out his duties under other Federal laws as required for traditional RCRA permits under §270.14(b)(20);
            --	Any other information the Director decides is necessary for demonstrating compliance with 40 CFR part 270, subpart H or for determining any additional RAP conditions that are necessary to protect human health and the environment; and

 If claiming as confidential any or all of the information on the RAP application or other submissions, a stamp with the words "confidential business information" on each page containing such information.

      (ii)	Respondent Activities:

      In order to comply with the above requirements, owners/operators must conduct the following activities:

 Prepare RAP application;
 Submit RAP application; and
 Prepare and submit additional information, if requested.

      (b)	RAP Modification, Revocation and Reissuance, and Termination

      Under 40 CFR 270.170, the Director must specify in a RAP, either directly or by reference, procedures for future modifications, revocations and reissuance, or termination of the RAP.  These procedures must provide adequate opportunities for public review and comment on any modification, revocation and reissuance, or termination that would significantly change the management of the remediation waste, or that otherwise merits public review and comment.

      If the RAP has been incorporated into a traditional RCRA permit, as allowed under section 270.85(c), then the RAP will be modified according to the applicable requirements in sections 270.40 through 270.42, revoked and reissued according to the applicable requirements in sections 270.41 and 270.43, or terminated according to applicable requirements of section 270.43.  [Note:  This ICR does not address the requirements in 40 CFR 270.41 through 270.43 for modifying, revoking and reissuing, and terminating a RCRA permit.  Refer OMB Control No. 2050-0009, for these requirements.]

      (i)	Data Item:

      The data item required of owners/operators includes:

 Information necessary to modify RAP, as specified in the RAP.

      (ii)	Respondent Activities:

      In order to comply with the above requirements, owners/operators must conduct the following activities:

 Prepare and submit information to modify RAP in accordance with procedures specified in the RAP.

      (c)	RAP Renewal

      Under 40 CFR 270.195, RAPs must be issued for a fixed term, not to exceed ten years, although they may be renewed upon approval by the Director in fixed increments of no more than ten years.  Under section 270.200, if an owner/operator wishes to renew his expiring RAP, he must follow the process for application for and issuance of RAPs.

      (d)	RAP Recordkeeping

      40 CFR 270.210 requires owners/operators of remediation waste management sites to keep records concerning their RAP.  All records must be kept for a period of at least three years from the date the RAP application is signed.

      (i)	Data Items:

      The data items required of owners/operators include:

 All data used to complete RAP applications and any supplemental information submitted; and
 Any operating and/or other records required as a condition of the RAP.

      (ii)	Respondent Activity:

      In order to comply with the above requirements, owners/operators must conduct the following activity:

 Maintain a file of RAP documents.

      (e)	RAP Transfers

      Under 40 CFR 270.220(a), owners/operators of remediation waste management sites may transfer their RAPs to new owners/operators.  To transfer the RAP, owners/operators must follow the requirements specified in their RAP for RAP modification to identify the new owner/operator, and incorporate any other necessary requirements.  The new owner/operator must submit a revised RAP application no later than 90 days before the scheduled change along with a written agreement containing a specific date for transfer of RAP responsibility between the owner/operator and the new permittees.

      Under 40 CFR 270.220(b), when a transfer of ownership occurs, the old owner/operator must comply with applicable requirements of 40 CFR part 264, subpart H, until the new owner/operator has demonstrated compliance (i.e., within six months of the date of the change).  [Note: The demonstrations under 40 CFR part 264, subpart H are addressed in OMB Control No. 2050-0120.]

      (i)	Data Items:

      The data item required of the owner/operator with the RAP includes:

 Information specified in the RAP for RAP modification.

      The data items required of the new owner/operator include:

 A revised RAP application; and
 A written agreement containing a specific date for transfer of RAP responsibility between the owner/operator and the new permittees.

      (ii)	Respondent Activities:

      In order to comply with the above requirements, owners/operators with the RAP must conduct the following activity:

 Modify RAP.

      In order to comply with the above requirements, the new owners/operators must conduct the following activities:

 Prepare a revised RAP application and a written agreement containing a specific date for transfer of RAP responsibility between the owner/operator and the new permittees; and
 Submit modified RAP and written agreement to the Director no later than 90 days before the scheduled changes.

      (f)	RAP for an Off-Site Location

      Under 40 CFR 270.230(a), owners/operators may request a RAP for hazardous remediation waste management activities at a location removed from the area where the remediation wastes originated if they believe such a location would be more protective than the contaminated area or areas in close proximity.  Owners/operators must request the RAP, and the Director will approve or deny the RAP, according to the requirements in part 270, subpart H (§270.230(c)).

      A RAP for an alternative location must meet the additional requirements specified in section 270.230(d), including the RCRA expanded public participation requirements in sections 124.31 through 124.33.  [Note:  This ICR does not address the expanded public participation requirements in 40 CFR 124.31 through 124.33.  Refer to OMB Control No. 2050-0149 for these requirements.]

      In addition, under section 270.230(e)(2), these alternative locations are remediation waste management sites, and retain the benefit of complying with the requirements of section 264.1(j) in lieu of part 264, subpart B, C, and D.

5.	THE INFORMATION COLLECTED -- AGENCY ACTIVITIES, COLLECTION METHODOLOGY, AND INFORMATION MANAGEMENT
      5(a)	Agency Activities

(1)	General Requirements for Hazardous Remediation Waste Management Sites

      (a)	Demonstrations for Remediation Waste Management Sites in Floodplains

      The Director must receive and review information submitted by owners/operators to meet the demonstration of section 264.18(b).

(2)  	Requirements for Staging Piles

 Designation of Staging Piles

      The Director must receive and review information submitted by all owners/operators seeking a staging pile designation.  Based on this information, the Director designates a staging pile in a permit, closure plan, or order under section 264.554(b) and establishes standards and design criteria in accordance with section 264.554(d).  In addition, the Director may receive and review additional information for staging pile designations submitted under section 264.554(c)(3).

 Staging Pile Extensions

      Under 40 CFR 264.554(h), the Director designates in the permit the length of time the owner/operator may use a staging pile, which may be up to two years.  Under section 264.554(i), the Director may grant extensions of up to 180 days for the use of staging piles.  The Director must receive and review request for extensions from owners/operators, and determine whether to grant an extension.  The Director may, as a condition of the extension, specify further standards and design criteria in the permit, closure plan, or order.

 Closure of Staging Piles

      40 CFR 264.554(j) provides that, within 180 days after the operating term of the staging pile expires, owners/operators must close a staging pile located in a previously contaminated area of the site by removing or decontaminating all remediation waste, contaminated containment system components, and structures and equipment contaminated with waste and leachate.  The owner/operator must also decontaminate subsoils in a manner and according to a schedule that the Director determines will protect human health and the environment.  The Director must include these requirements in the permit, closure plan, or order in which the staging pile is designated.

      Section 264.554(k) provides that, within 180 days after the operating term of the staging pile expires, owners/operators must close a staging pile located in an uncontaminated area of the site according to sections 264.258(a) and 264.111; or according to sections 265.258(a) and 265.111.  The Director must include the above requirement in the permit, closure plan, or order in which the staging pile is designated.

 Incorporation of Staging Piles into Existing Permits

      40 CFR 264.554(l) specifies procedures for incorporating staging piles into existing permits (including RAPs), closure plans, or orders.  Pursuant to section 264.554(l)(1), a permit, other than a RAP, may be modified to incorporate a staging pile or staging pile operating term extension as part of an Agency-initiated permit modification under section 270.41or as part of an owner/operator initiated Class 2 permit modification under section 270.42.

 Data Availability

      Under section 264.554(m), the Director must document the rationale for designating a staging pile or staging pile operating term extension and make this documentation available to the public.

(3) 	Remedial Action Plans

      (a) 	RAP Applications

      According to 40 CFR 270.95 and 270.120, the Director must receive RAP applications for approval.  Sections 270.130 through 270.140 identify the activities the Director must follow to review and approve RAP applications.  As part of this process, the Director may require RAP applicants to provide additional information, as described in section 270.110(i).  When additional information is requested, the Director must receive and review the information to ensure that the RAP application complies with applicable hazardous remediation waste management standards and, if necessary, develop additional permit conditions.

      Based on the RAP application, the Director must prepare either a draft RAP or a notice of intent to deny the RAP.  Section 270.135 describes what the Director must include in a draft RAP.

      Under section 270.140(a), the Director must prepare a statement of basis that briefly describes the derivation of conditions of the draft RAP or the rationale for the notice of intent to deny the RAP.  Under section 270.140(b), the Director must compile an administrative record.  Under section 270.140(c), the Director must make that record available to the public.  The administrative record should include the following items:

 The RAP application and any supporting data furnished by the applicant;
 The draft RAP or notice of intent to deny;
 The statement of basis and all documents cited therein; and
 Other documents supporting the decision to approve or deny the RAP

      Under 40 CFR 270.85(c), an owner/operator may obtain a RAP for managing hazardous remediation waste at an already permitted RCRA facility.  This RAP must be approved as a modification to the existing permit according to the requirements of section 270.41 or section 270.42.  When the permit is modified, the RAP becomes part of the RCRA permit.

      (b) 	Public Comment on the Draft RAP or Notice of Intent to Deny

      Under 40 CFR 270.145, the Director must notify the applicant of his intention to approve or deny the RAP application.  The Director also must notify the public of his intention to approve or deny the RAP application by publishing a notice in a major local newspaper or general circulation and broadcasting his intention over a local radio station.  In addition, the Director must notify the applicable local government and State agencies of his intention.

      The public notice must provide an opportunity for the public to submit written comments on the draft RAP or notice of intent to deny within at least 45 days.  If, within the comment period, the Director receives written notice of opposition to his intention to approve or deny the RAP application and a request for a hearing, the Director must hold an informal public hearing to discuss issues related to the approval or denial of the RAP application.  The Director may also determine on his own initiative that an informal hearing is appropriate.  The Director must notify the public that a hearing will take place.

      (c) 	RAP Final Decisions

      40 CFR 270.150 specifies the procedures by which the Director must make a final decision on RAP applications.  If the RAP is to be approved, the Director must issue a final RAP and notify the applicant and all commenters on the draft RAP of the approval in writing.  If the RAP is denied, the Director must prepare and send to the applicant and all commenters on the draft RAP of the denial in writing.  Before issuing a final decision, the Director must compile an administrative record that includes the following items:

 All comments received during the public comment period;
 Tapes or transcripts of any hearings;
 Any written materials submitted at such hearings;
 The responses to comments;
 Any new material placed in the record since issuance of the draft RAP;
 Any other documents supporting the RAP; and
 A copy of the final RAP.

Administrative Appeal of a RAP Application

      Under 40 CFR 270.155, the Director must review administrative appeals of the Director's decision to approve or deny a RAP.  The Director must then give public notice of any grant of review of RAPs by the Environmental Appeals Board (EAB).

      (e)	RAP Modification, Revocation and Reissuance, and Termination

      Under 40 CFR 270.170, the Director must specify in a RAP, either directly or by reference, procedures for future modifications, revocations and reissuance, or termination of the RAP.  These procedures must provide adequate opportunities for public review and comment on any modification, revocation and reissuance, or termination that would significantly change the management of the remediation waste, or that otherwise merits public review and comment.

      Under sections 270.175 and 270.185, the Director may choose to modify the final RAP because the owner/operator made material and substantial alterations to the RAP, new information became available, or standards and regulations under which the RAP was submitted have changed.  In addition, if the RAP includes a compliance schedule, the Director may modify it if events over which the owner/operator has little control over affect RAP activities (e.g., a flood).

      If the RAP has been incorporated into a traditional RCRA permit, as allowed under section 270.85(c), then the RAP will be modified according to the applicable requirements in sections 270.40 through 270.42, revoked and reissued according to the applicable requirements in sections 270.41 and 270.43, or terminated according to applicable requirements of section 270.43.

      (f) 	Administrative Appeal of a Modification, Revocation and Reissuance, or Termination of a RAP

      Under 40 CFR 270.190(c), the EAB must review administrative appeals of revisions to a RAP.  The Board must act on the appeal within 60 days of receiving it; otherwise, the appeal is considered denied.

      (g) 	RAP Expiration

      Under 40 CFR 270.195, the Director may renew the RAP for up to 10 years.  In addition, the Director must review any RAP for hazardous waste land disposal five years after the RAP is issued or reissued.

      (h) 	RAP Transfers

      Under 40 CFR 270.220, once the new owner/operator has submitted a revised RAP application, and has demonstrated compliance with 40 CFR part 264, subpart H, the Director will notify the previous owner/operator that he or she no longer has to comply with 40 CFR part 264, subpart H.

      (i) 	RAP for an Off-Site Location

      Under 40 CFR 270.230, if the applicant wishes to perform remediation waste management activities under a RAP at a location removed from the area where the waste originated, the Director must approve a RAP for this alternative location and must include in the RAP that the alternative location meets the requirements of section 270.230(d).

      5(b)	Collection Methodology and Management

      In collecting and analyzing the information submitted, EPA uses equipment such as personal computers and applicable data base software, when appropriate.  As part of the RAP application process, the public will receive information through newspaper announcements and other media, and, upon request, will have access to additional data in the administrative record.

      5(c) 	Small Entity Flexibility

      RAPs are not mandatory.  The Agency believes that the RAP provisions provide a flexible, less burdensome alternative to RCRA permitting at remediation waste management sites.

      Staging piles provide an alternative to placing hazardous remediation waste in a waste pile.  Staging piles are less burdensome because the waste need not be treated to land disposal restriction standards before being placed in the pile, as is the case for a waste pile.

      These regulatory alternatives may decrease burden for both small and large entities.

      5(d)	Collection Schedule

(1)	Requirements for Staging Piles

      As provided under 40 CFR 264.554(d)(1)(iii), a staging pile must not operate for more than two years, except when the Director grants an operating term extension under section 264.554(i).  The owner/operator must measure the two-year limit, or other operating term specified by the Director in the permit, closure plan, or order, from the first time remediation waste is placed into the staging pile.  The owner/operator must maintain a record of the date when remediation waste was first placed into the staging pile for the life of the permit, order, or approved closure plan, or for three years, whichever is longer.

      Under 40 CFR 264.554(i)(1), the Director may grant one operating term extension for a staging pile of up to 180 days beyond the operating term limit contained in the permit, closure plan, or order.  To obtain an extension, owners/operators must document that an extension will not pose a threat to human health and the environment and is necessary to ensure timely and efficient implementation of remedial actions at the facility.

      40 CFR 264.554(k) provides that, within 180 days after the operating term of the staging pile expires, owners/operators must close a staging pile located in an uncontaminated area of the site in accordance with sections 264.258(a) and 265.258(a) and sections 264.111 and 265.111 (i.e., the closure requirements for waste piles).

(2)	Remedial Action Plans

      Under 40 CFR 270.220(a), owners/operators of remediation waste management sites may transfer their RAPs to new owners/operators.  To transfer the RAP, owners/operators must follow the requirements specified in their RAP for RAP modification to identify the new owner/operator, and incorporate any other necessary requirements.  The new owner/operator must submit a revised RAP application no later than 90 days before the scheduled change along with a written agreement containing a specific date for transfer of RAP responsibility between the owner/operator and the new permittees.

6.	ESTIMATING THE HOUR AND COST BURDEN OF THE COLLECTION

      6(a)	Estimating Respondent Hours

      EPA estimates respondent hourly burden for all the information collection requirements covered in this ICR in Exhibit 1.  The burden estimates for each activity presented in Exhibit 1 include the burden hours (total and by labor type) per respondent, as well as the overall burden hours for all respondents.

      6(b)	Estimating Respondent Costs

      Exhibit 1 estimates the annual costs to respondents based on the cost of labor, capital, and operations and maintenance (O&M).

(1)	Labor Costs

      	For the private sector, EPA estimates an average hourly respondent labor cost (including fringe and overhead) of $135.07 for legal staff, $79.84 for managerial staff, $59.47 for technical staff, and $35.78 for clerical staff.  These respondent labor costs were obtained from the previously approved ICR (i.e., EPA ICR Number 1775.08), and updated to 2021 levels using Employment Cost Indexes developed by the U.S. Bureau of Labor Statistics.

(2)	Capital Costs

      Capital costs usually include any produced physical good needed to provide the necessary information, such as machinery, computers, and other equipment.  EPA does not anticipate that respondents will incur capital costs in carrying out the information collection requirements covered in this ICR.

(3)	Operation & Maintenance Costs

      O&M costs are those costs associated with a paperwork requirement incurred continually over the life of the ICR.  They are defined by the Paperwork Reduction Act of 1995 as "the recurring dollar amount of cost associated with O&M or purchasing services."  For this ICR, O&M costs cover mailing costs ($7.59 per submittal) and waste analysis costs ($1,400 per respondent).

      6(c)	Estimating Agency Hour and Cost Burden

      EPA estimates the Agency hour and cost burden associated with the information collection requirements covered in this ICR.  EPA estimates an average hourly labor cost of $98.08 for legal staff (GS15, Step 5), $86.54 for managerial staff (GS-15, Step 1), $62.27 for technical staff (GS-13, Step 1), and $26.56 for clerical staff (GS-06, Step 1).  To derive these hourly estimates, EPA referred to the General Schedule (GS) Salary Table 2021.  This publication summarizes the unloaded (base) hourly rate for various labor categories in the Federal Government.  EPA then applied the standard government overhead factor of 1.6 to the unloaded rate to derive loaded hourly rates.

      6(d)	Estimating State Agency Burden and Cost

	Thirty eight (38) States are authorized for the HWIR program, with an additional four (4) States expected to be authorized over the next three years.  EPA estimates the State Agency hour and cost burden associated with all information collection requirements covered in this ICR in Exhibit 3.

	For State agencies, EPA estimates an average hourly respondent labor cost (including fringe and overhead) of $63.02 for legal staff, $59.16 for managerial staff, $35.39 for technical staff, and $22.57 for clerical staff.  These respondent labor costs were obtained from the previously approved ICR (i.e., EPA ICR Number 1775.08), and updated to 2021 levels using Employment Cost Indexes developed by the U.S. Bureau of Labor Statistics.

      6(e)	Estimating the Respondent Universe and Total Hour and Cost Burden

(1)	Respondent Universe

      (a)	Hazardous Remediation Waste Management Sites Subject to 40 CFR 264.1(j) and Part 270, Subpart H

      In estimating the number of owners/operators of hazardous remediation waste management sites subject to 40 CFR 264.1(j) and part 270, subpart H (i.e., the requirements for sites with RAPs), EPA conducted consultations with State and EPA Regional representatives and has come to the conclusion that the number of entities covered by this ICR has not changed significantly from the previous renewal.  Based on this analysis, EPA estimates that, currently, there are 44 hazardous remediation waste management sites with RAPs.

      Note that this ICR addresses only non-permitted sites under 40 CFR 264.1(j) and part 270, subpart H.  As discussed earlier in this ICR, a site may conduct cleanup through a RAP, permit, or other specified mechanism.  Permitted facilities would obtain a RAP by modifying their permit.  These activities are already addressed in OMB Control No. 2050-0009.  Therefore, this ICR addresses only non-permitted sites under the RAP requirements.

      (b)	Hazardous Remediation Waste Management Sites Subject to 40 CFR 264.554

      In estimating the number of owners/operators of hazardous remediation waste management sites subject to the 40 CFR 264.554 requirements for staging piles, EPA referred to RCRAInfo.  Based on analysis of RCRAInfo data, EPA estimates that, currently, there are 53 existing hazardous remediation waste management sites with staging piles.  EPA also estimates that, each year, 45 owners/operators of non-permitted hazardous remediation waste management sites will seek a new staging pile designation. Permitted facilities must modify their permit to incorporate a staging pile which is covered by OMB Control No. 2050-0009.
(2)	Annual Respondent Hour and Cost Burden

      (a)	Reading the Regulations

      EPA estimates that 128 owners/operators of hazardous remediation waste management sites (i.e., 30 + 53 + 45 = 128) will be subject to the requirements in this ICR and will, therefore, read the regulations each year.

      (b)	General Requirements for Hazardous Remediation Waste Management Sites

      Following is a discussion of the Agency's burden assumptions regarding sites subject to the 40 CFR 264.1(j) requirements.

      (b1)	Waste Analyses

      Owners/operators of hazardous remediation waste management sites are required to obtain a detailed chemical and physical analysis of a representative sample of the hazardous remediation waste to be managed at the site.  EPA estimates that the owners/operators of all 30 remediation sites will perform waste analyses in order to obtain this information each year.

      (b2)	Inspections

      Owners/operators must inspect the remediation waste management site for malfunctions, deterioration, operator errors, and discharges that may be causing, or may lead to, a release of hazardous waste constituents to the environment, or a threat to human health.  Note that this ICR burdens inspections under Section b6 of this subsection, "Compliance Plan."

      (b3)	Demonstrations for Remediation Waste Management Sites in Floodplains

      Hazardous remediation waste management units must be designed, constructed, operated, and maintained in such a way as to prevent washout of any hazardous waste within a 100-year floodplain.  Exceptions are allowed for sites that meet the demonstration requirements of section 264.18(b).

      EPA assumes that owners/operators of existing remediation sites have already prepared and submitted the above demonstration, if applicable.  EPA further assumes that, each year, five percent of owners/operators of new remediation sites will prepare and submit the demonstration.  Thus, EPA estimates that no owner/operator of a remediation site will need to comply with this information collection requirement during the three-year period covered in this ICR.

      (b4)	Construction Quality Assurance Program

      Owners/operators of hazardous remediation waste management sites are required to develop and maintain a construction quality assurance program for all surface impoundments, waste piles, and landfill units, as specified.  EPA assumes that existing remediation sites have already developed their construction quality assurance programs.  Thus, EPA estimates that only the eight new remediation sites will have to conduct this activity each year.

      (b5)	Contingency and Emergency Plan

      Owners/operators of hazardous remediation waste management sites are required to develop and maintain procedures to prevent accidents.  EPA assumes that existing remediation sites have already developed these procedures.  Thus, EPA estimates that only the eight new remediation sites will have to conduct this activity each year.

      Owners/operators of hazardous remediation waste management sites also are required to develop and maintain a contingency and emergency plan.  EPA assumes that existing remediation sites have already developed their contingency and emergency plans.  Thus, EPA estimates that only the eight new remediation sites will have to conduct this activity each year.

      (b6)	Compliance Plan

      Owners/operators of hazardous remediation waste management sites are required to develop, maintain, and implement a plan to meet the requirements in sections 264.1(j)(2) through (j)(6) and sections 264.1(j)(9) through (j)(10).  EPA estimates that the owners/operators of all 30 remediation sites will need to comply with this information collection requirement each year.

      (b7)	Recordkeeping Requirements

      Owners/operators of hazardous remediation waste management sites are required to maintain records documenting compliance with sections 264.1(j)(1) through (j)(12) in the operating record.  EPA estimates that the owners/operators of all 30 remediation sites will need to comply with these recordkeeping requirements each year.

      (c)	Requirements for Staging Piles

      Following is a discussion of the Agency's burden assumptions regarding sites subject to the 40 CFR 264.554 requirements for staging piles.

      (c1)	Designation of Staging Piles

      To manage hazardous remediation waste in a staging pile, owners/operators of hazardous remediation waste management sites must seek a staging pile designation from the Director.  EPA estimates that, each year, 45 owners/operators of hazardous remediation waste management sites will seek staging pile designations under section 264.554(c).  EPA also estimates that one percent of these owners/operators will need to prepare and submit additional information requested by the Director.

      (c2)	Staging Pile Recordkeeping

      Owners/operators of staging piles must keep a record of the date when waste was first placed in the staging pile.  EPA estimates that, each year, all 45 owners/operators of hazardous remediation waste management sites seeking staging pile designations under section 264.554(c) will need to comply with the recordkeeping requirements under section 264.554(d)(1)(iii).

      (c3)	Staging Pile Extensions

      Staging piles are intended to be used for up to two years.  Under certain circumstances, the Director may grant an extension of up to six months.  EPA estimates that, each year, 20 percent of owners/operators with existing staging piles will request an operating term extension for a staging pile.

      (d)	Remedial Action Plans

      Following is a discussion of the Agency's burden assumptions regarding sites subject to the 40 CFR part 270, subpart H requirements.

      (d1)	RAP Application

      EPA estimates that, each year, eight owners/operators of hazardous remediation waste management sites will submit a RAP application.  EPA assumes that 50 percent of these owners/operators will be able to use existing documents that satisfy the requirements for a RAP in preparing their RAP applications.  The remaining 50 percent will not have existing documents that satisfy the requirements for a RAP and thus, will have to develop RAP applications from new information.  All owners/operators must submit their RAP application to the Director.

      The Director may request additional information if necessary.  EPA estimates that ten percent of owners/operators submitting RAP applications each year will be required to prepare and submit additional information.

      (d2)	RAP Modification, Revocation and Reissuance, and Termination

      To modify a RAP, owners/operators must prepare and submit information to modify their RAP in accordance to the procedures specified in the RAP.  EPA estimates that, each year, five percent of owners/operators of hazardous remediation waste management sites with a RAP will need to modify it.  Thus, EPA estimates that two owner/operators will need to modify his RAP.

      (d3)	RAP Recordkeeping

      Owners/operators of hazardous remediation waste management sites with RAPs are required to keep records concerning their RAPs.  EPA estimates that all owners/operators of hazardous remediation waste management sites with RAPs will maintain a file of RAP documents.

      (d4)	RAP Transfers

      Owners/operators of hazardous remediation waste management sites with RAPs may transfer the RAPs to new owners/operators.  EPA assumes that, each year, one percent of the owners/operators will transfer their RAP.  Thus, EPA estimates that no owner/operator will need to comply with this information collection requirement during the three-year period covered in this ICR.

      6(f)	Bottom Line Hour and Cost Burden

(1)	Private Respondent Tally

      Exhibit 1 shows the aggregate annual hour and cost burden to respondents.  As shown in the exhibit, EPA estimates the annual respondent burden to be 3,386 hours and $279,473 (which includes $225,780 in labor costs and $53,693 in operating and maintenance costs).

(2)	Federal Agency Tally

      Exhibit 2 shows the annual Federal Agency hour and cost burden associated with all the requirements covered in this ICR.  As shown in this exhibit, EPA estimates the annual Federal Agency burden to be 438 hours and $28,513 (labor cost only).

(3)	State Agency Tally

      Exhibit 3 shows the annual State Agency hour and cost burden associated with all the requirements covered in this ICR.  As shown in this exhibit, EPA estimates the annual State Agency burden to be 1,728 hours and $68,615 (labor cost only).

      6(g)	Reasons for Change in Burden

      There is a decrease of 1,197 hours in the total estimated respondent burden compared with the ICR currently approved by OMB. This decrease is due to an adjustment in Agency calculations.

      6(h)	Burden Statement

      For owners/operators of hazardous remediation waste management sites the reporting burden is estimated to be 25 hours per respondent per year. The recordkeeping burden is estimated to be 2 hours per respondent per year.

Burden means the total time, effort, or financial resources expended by persons to generate, maintain, retain, or disclose or provide information to or for a Federal agency. This includes the time needed to review instructions; develop, acquire, install, and utilize technology and systems for the purposes of collecting, validating, and verifying information, processing and maintaining information, and disclosing and providing information; adjust the existing ways to comply with any previously applicable instructions and requirements; train personnel to be able to respond to a collection of information; search data sources; complete and review the collection of information; and transmit or otherwise disclose the information. An agency may not conduct or sponsor, and a person is not required to respond to, a collection of information unless it displays a currently valid OMB control number. The OMB control numbers for EPA's regulations are listed in 40 CFR part 9 and 48 CFR chapter 15.
      To comment on the Agency's need for this information, the accuracy of the provided burden estimates, and any suggested methods for minimizing respondent burden, including the use of automated collection techniques, EPA has established a public docket for this ICR under Docket ID Number EPA-HQ-OLEM-2018-0543, which is available for online viewing at www.regulations.gov. Due to public health concerns related to COVID-19, the EPA Docket Center and Reading Room are open to the public by appointment only. Our Docket Center staff also continues to provide remote customer service via email, phone, and webform. Hand deliveries or couriers will be received by scheduled appointment only. For further information and updates on EPA Docket Center services, please visit us online at https://www.epa.gov/dockets. The EPA continues to carefully and continuously monitor information from the Centers for Disease Control and Prevention (CDC), local area health departments, and our Federal partners so that we can respond rapidly as conditions change regarding COVID-19.

An electronic version of the public docket is available at www.regulations.gov. This site can be used to submit or view public comments, access the index listing of the contents of the public docket, and to access those documents in the public docket that are available electronically. When in the system, select "search," then key in the Docket ID Number identified above. Also, you can send comments to the Office of Information and Regulatory Affairs, Office of Management and Budget, 725 17th Street, NW, Washington, D.C. 20503, Attention: Desk Officer for EPA. Please include the EPA Docket ID Number EPA-HQ-OLEM-2018-0543 and OMB Control Number 2050-0161 in any correspondence.


[Federal Register: November 14, 2008 (Volume 73, Number 221)]
[Proposed Rules]
[Page 67433-67435]
[DOCID:fr14no08-38]

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DEPARTMENT OF TRANSPORTATION

Federal Aviation Administration

14 CFR Part 39

[Docket No. FAA-2008-1206; Directorate Identifier 2008-NE-19-AD]
RIN 2120-AA64

Airworthiness Directives; General Electric Co. (GE) CF6-80A
Series Turbofan Engines

AGENCY: Federal Aviation Administration (FAA), Department of
Transportation (DOT).

ACTION: Notice of proposed rulemaking (NPRM).

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

SUMMARY: The FAA proposes to adopt a new airworthiness directive (AD)
for GE CF6-80A series turbofan engines with a high-pressure turbine
rotor (HPTR) stage 1 disk, part number (P/N) 9367M45G06, installed.
This proposed AD would require removing any HPTR stage 1 disk, P/N
9367M45G06, before exceeding 2,075 cycles-since-new (CSN). This
proposed AD results from an error by GE that incorrectly cited a cyclic
life of 12,600 CSN for the HPTR stage 1 disk, P/N 9367M45G06. We are
proposing this AD to prevent the HPTR stage 1 disk from exceeding its
part life which could cause fatigue cracks to start and grow. These
cracks could result in a possible uncontained disk failure and damage
to the airplane.

DATES: We must receive any comments on this proposed AD by January 13,
2009.

ADDRESSES: Use one of the following addresses to comment on this
proposed AD.
     Federal eRulemaking Portal: Go to http://
www.regulations.gov and follow the instructions for sending your
comments electronically.
     Mail: Docket Management Facility, U.S. Department of
Transportation, 1200 New Jersey Avenue, SE., West Building Ground
Floor, Room W12-140, Washington, DC 20590-0001.

     Hand Delivery: Deliver to Mail address above between 9
a.m. and 5 p.m., Monday through Friday, except Federal holidays.
     Fax:<PHONE_NUMBER>.

FOR FURTHER INFORMATION CONTACT: Robert Green, Aerospace Engineer,
Engine Certification Office, FAA, Engine & Propeller Directorate, 12
New England Executive Park, Burlington, MA 01803; e-mail:
<EMAIL_ADDRESS>telephone<PHONE_NUMBER>; fax<PHONE_NUMBER>.

SUPPLEMENTARY INFORMATION:

Comments Invited

    We invite you to send us any written relevant data, views, or
arguments regarding this proposal. Send your comments to an address
listed under ADDRESSES. Include ``Docket No. FAA-2008-1206; Directorate
Identifier 2008-NE-19-AD'' in the subject line of your comments. We
specifically invite comments on the overall regulatory, economic,
environmental, and energy aspects of the proposed AD. We will consider
all comments received by the closing date and may amend the proposed AD
in light of those comments.
    We will post all comments we receive, without change, to http://
www.regulations.gov, including any personal information you provide. We
will also post a report summarizing each substantive verbal contact
with FAA personnel concerning this proposed AD. Using the search
function of the Web site, anyone can find and read the comments in any
of our dockets, including, if provided, the name of the individual who
sent the comment (or signed the comment on behalf of an association,
business, labor union, etc.). You may review the DOT's complete Privacy
Act Statement in the Federal Register published on April 11, 2000 (65
FR 19477-78).

Examining the AD Docket

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

Discussion

    During a recent GE internal audit, comparing the life-limited parts
certification documents to the part life limits specified in the
Airworthiness Limitations Section of the Instructions for Continuing
Airworthiness, GE found that the life limits for the CF6-80A series
engines incorrectly specified a cyclic life of 12,600 CSN for the HPTR
stage 1 disk, P/N 9367M45G06. GE has determined that the correct life
limit for the HPTR stage 1 disk, P/N 9367M45G06, is 2,075 CSN. Failure
to remove these disks from service before exceeding the new, reduced
life limit of 2,075 CSN could result in fatigue cracks, leading to a
possible uncontained disk failure and damage to the airplane.

FAA's Determination and Requirements of the Proposed AD

    We have evaluated all pertinent information and identified an
unsafe condition that is likely to exist or develop on other products
of this same type design. We are proposing this AD, which would require
removing from service any HPTR stage 1 disk, P/N 9367M45G06, before it
exceeds 2,075 CSN.

Costs of Compliance

    We estimate that this proposed AD would affect 10 engines installed
on airplanes of U.S. registry. We also estimate that it would take
about 110 work-hours per engine to perform the proposed actions, and
that the average labor rate is $80 per work-hour. Required parts would
cost about $437,000 per engine. Based on these figures, we estimate the
total cost of the proposed AD to U.S. operators to be $4,462,000.

Authority for This Rulemaking

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

Regulatory Findings

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

List of Subjects in 14 CFR Part 39

    Air transportation, Aircraft, Aviation safety, Safety.

The Proposed Amendment

    Under the authority delegated to me by the Administrator, the
Federal Aviation Administration proposes to amend 14 CFR part 39 as
follows:

PART 39--AIRWORTHINESS DIRECTIVES

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

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

Sec.  39.13  [Amended]

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

General Electric Co. (GE): Docket No. FAA-2008-1206; Directorate
Identifier 2008-NE-19-AD.

Comments Due Date

    (a) The Federal Aviation Administration (FAA) must receive
comments on this airworthiness directive (AD) action by January 13,
2009.

Affected ADs

    (b) None.

Applicability

    (c) This AD applies to GE CF6-80A, CF6-80A1, CF6-80A2, and CF6-
80A3 turbofan engines with a high-pressure turbine rotor (HPTR)
stage 1 disk, part number (P/N) 9367M45G06, installed. These engines
are installed on, but not limited to, Airbus A310 series and Boeing
767 series airplanes.

Unsafe Condition

    (d) This AD results from an error by GE that incorrectly cited a
cyclic life of 12,600 CSN in the Airworthiness Limitations Section
(ALS) of the Instructions for Continued Airworthiness (ICA) for the
HPTR, P/N 9367M45G06. We are issuing this AD to prevent the HPTR
stage 1 disk from exceeding its part life which could cause fatigue
cracks to start and grow. These cracks could result in a possible
uncontained disk failure and damage to the airplane.

Compliance

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

New Reduced Life Limit for HPTR Stage 1 Disks, P/N 9367M45G06

    (f) After the effective date of this AD, remove HPTR stage 1
disks, P/N 9367M45G06, from service before exceeding the new,
reduced life limit of 2,075 cycles-since-new.

Alternative Methods of Compliance

    (g) The Manager, Engine Certification Office, has the authority
to approve alternative methods of compliance for this AD if
requested using the procedures found in 14 CFR 39.19.

Special Flight Permits

    (h) Under 14 CFR part 39.23, we are prohibiting any special
flight permits.

Related Information

    (i) Contact Robert Green, Aerospace Engineer, Engine
Certification Office, FAA, Engine & Propeller Directorate, 12 New
England Executive Park, Burlington, MA 01803; e-mail:
<EMAIL_ADDRESS>telephone<PHONE_NUMBER>; fax<PHONE_NUMBER>,
for more information about this AD.

    Issued in Burlington, Massachusetts, on November 7, 2008.
Peter A. White,
Assistant Manager, Engine and Propeller Directorate, Aircraft
Certification Service.
 [FR Doc. E8-27080 Filed 11-13-08; 8:45 am]

BILLING CODE 4910-13-P


NOTICE OF CHAUTAUQUA AIRLINES, INC.

D/B/A TW EXPRESS

Pursuant to Order 2001-9-20, Chautauqua Airlines, Inc., d/b/a/ TW
Express gives the following notice of service reductions that have been
implemented prior to October 1, 2001:

Rochester, MN (RST).  Chautauqua terminated TWExpress service at
Rochester, MN on September 30, 2001.  Prior to that date, Chautauqua
operated three daily round trip flights between Rochester, MN and St.
Louis, MO.

Respectfully submitted,

Jeffrey B. Jones

VP Planning

Chautauqua Airlines, Inc.

2500 S. High School Road, Suite 160

Indianapolis, IN 46241


[Federal Register Volume 79, Number 247 (Wednesday, December 24, 2014)]
[Notices]
[Pages 77515-77516]
[FR Doc No: 2014-30109]

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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2007-D-0369]

Bioequivalence Recommendations for Methylphenidate Hydrochloride
Extended-Release Oral Suspension; Draft Guidance for Industry;
Availability

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice.

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

SUMMARY: The Food and Drug Administration (FDA) is announcing the
availability of a draft guidance for industry entitled ``Bioequivalence
Recommendations for Methylphenidate Hydrochloride Extended-Release Oral
Suspension.'' The recommendations provide specific guidance on the
design of bioequivalence (BE) studies to support abbreviated new drug
applications (ANDAs) for methylphenidate hydrochloride (HCl) extended-
release oral suspension.

DATES: Although you can comment on any guidance at any time (see 21 CFR
10.115(g)(5)), to ensure that the Agency considers your comments on
this draft guidance before it begins work on the final version of the
guidance, submit either electronic or written comments on the draft
guidance by February 23, 2015.

ADDRESSES: Submit written requests for single copies of the draft
guidance to the Division of Drug Information, Center for Drug
Evaluation and Research, Food and Drug Administration, 10001 New
Hampshire Ave., Hillandale Building, 4th Floor, Silver Spring, MD
20993-0002. Send one self-addressed adhesive label to assist that
office in processing your requests. See the SUPPLEMENTARY INFORMATION
section for electronic access to the draft guidance document.
    Submit electronic comments on the draft guidance to http://www.regulations.gov. Submit written comments to the Division of Dockets
Management (HFA-305), Food and Drug Administration, 5630 Fishers Lane,
rm. 1061, Rockville, MD 20852.

FOR FURTHER INFORMATION CONTACT: Kris Andr[eacute], Center for Drug
Evaluation and Research (HFD-600), Food and Drug Administration, 10903
New Hampshire Ave., Bldg. 75, Rm. 4726, Silver Spring, MD 20993-0002,
240-402-7959.

SUPPLEMENTARY INFORMATION:

I. Background

    In the Federal Register of June 11, 2010 (75 FR 33311), FDA
announced the availability of a guidance for industry, ``Bioequivalence
Recommendations for Specific Products,'' which explained the process
that would be used to make product-specific BE recommendations
available to the public on FDA's Web site at http://www.fda.gov/Drugs/GuidanceComplianceRegulatoryInformation/Guidances/default.htm. As
described in that guidance, FDA adopted this process as a means to
develop and disseminate product-specific BE recommendations and provide
a meaningful opportunity for the public to consider and comment on
those recommendations. This notice announces the availability of draft
BE recommendations for methylphenidate HCl extended-release oral
suspension.
    New drug application 202100 for Quillivant XR (methylphenidate HCl)
extended-release oral suspension was initially approved by FDA in
September 2012. There are no approved ANDAs for this product. FDA is
now issuing a draft guidance for industry on BE recommendations for
generic methylphenidate HCl extended-release oral suspension (Draft
Methylphenidate HCl Oral Suspension BE Recommendations).
    In August 2014, Pfizer, Inc., manufacturer of the reference listed
drug, Quillivant XR, submitted a citizen petition requesting that FDA
establish certain BE requirements for any new drug product that
references Quillivant XR and seeks approval by means of demonstrating
BE to Quillivant XR (Docket No. FDA-2014-P-1269). FDA is reviewing the
issues raised in the petition.
    This draft guidance is being issued consistent with FDA's good
guidance practices regulation (21 CFR 10.115). The draft guidance, when
finalized, will represent the Agency's current thinking on the design
of BE studies to support ANDAs for methylphenidate HCl extended-release
oral suspension. It does not create or confer any rights for or on any
person and does not operate to bind FDA or the public. An alternative
approach may be used if such approach satisfies the requirements of the
applicable statutes and regulations.

II. Comments

    Interested persons may submit to the Division of Dockets Management
(see ADDRESSES) either electronic or written

comments regarding this document. It is only necessary to send one set
of comments. Identify comments with the docket number found in brackets
in the heading of this document. Received comments may be seen in the
Division of Dockets Management between 9 a.m. and 4 p.m., Monday
through Friday.

III. Electronic Access

    Persons with access to the Internet may obtain the document at
either http://www.fda.gov/Drugs/GuidanceComplianceRegulatoryInformation/Guidances/default.htm or http://www.regulations.gov.

    Dated: December 18, 2014.
Leslie Kux,
Associate Commissioner for Policy.
[FR Doc. 2014-30109 Filed 12-23-14; 8:45 am]
BILLING CODE 4164-01-P