RENEWAL OF INFORMATION COLLECTION REQUEST ( No. 1463.05) FOR THE NATIONAL OIL AND HAZARDOUS SUBSTANCES POLLUTION CONTINGENCY PLAN ( 40 CFR PART 300)

1. IDENTIFICATION OF THE INFORMATION COLLECTION l( a) Title of the Information Collection Record keeping and reporting requirements of the Superfund remedial program as specified in the National Oil and Hazardous Substances Pollution Contingency Plan ( NCP; 40 CFR Part 300).

l( b) Short Characterization The Comprehensive Environmental Response, Compensation, and Liability Act of 1980 ( CERCLA or Superfund; 42 USC 9601 et seq.), as amended, establishes broad Federal authority to undertake removal and remedial actions in response to releases or threats of releases of hazardous substances and certain pollutants and contaminants into the environment. The NCP sets forth requirements for carrying out the response authorities established under CERCLA.

For states, this ICR addresses the record keeping and reporting provisions of the NCP that affect those states that voluntarily participate in the remedial action phase of the Superfund program. ( Record keeping and reporting requirements of the pre remedial action phase except those tied to community involvement have been addressed in the ICR prepared for the revisions to the Hazard Ranking System ( HRS) ( OMB Control No. 2050 0095). Record keeping and reporting provisions for the removal program except, again, those tied to community involvement also are not included in this ICR because the Federal government has the lead for removal actions.) Remedial responses under the Superfund program fall into the pre remedial action phase ( during which the extent of site contamination is assessed) and the remedial action phase ( during which investigations are conducted to identify and characterize contaminants present and to determine viable remedies for a site, the remedy is chosen and the cleanup or construction is completed). The NCP includes the following reporting and record keeping provisions for the remedial phase of the Superfund program:

( 1) States that voluntarily take the lead in remedial activities at Superfund sites must conduct the activities in a manner consistent with CERCLA ( 40 CFR 300.515( a)). Therefore, at a state lead site, the state must: develop a Remedial Investigation and Feasibility Study ( RI/ FS); prepare a Proposed Plan; issue a Record of Decision ( ROD); complete community interviews; prepare a Community Involvement Plan ( CIP), and provide information to the public; and ( 2) States must identify and communicate potential state applicable or relevant and appropriate requirements ( ARARs) at all Superfund sites within the state ( 40 CFR 300.400( g)).

In addition, this ICR addresses the record keeping and reporting provisions of the NCP that affect communities voluntarily providing their concerns to the lead agency about the Superfund process. This ICR also addresses the record keeping and reporting provisions imposed 2 on communities when those communities voluntarily provide feedback on community involvement activities. Community involvement related to NCP requirements and community feedback may occur during all phases of the Superfund process including, pre remedial, remedial, removal ( short term response actions), and operation and maintenance ( which may include such activities as ground water and air monitoring, inspection and maintenance of the treatment equipment remaining on site, and maintenance of any security measures or institutional controls.) Specifically, members of the community surrounding a Superfund site may participate in community interviews ( 40 CFR 300.43( c)) conducted by EPA in order to prepare a CIP or serve on Technical Assistance Grant ( TAG) groups, as provided for in Superfund Amendments and Reauthorization Act of 1986 ( SARA), as well as in Community Advisory Groups ( CAGs), as provided in Superfund Administrative Reforms. Community groups focused on the technical assistance provided through the Technical Outreach Services for Communities ( TOSC) program may also participate. Participation may also take the form of attending formal and informal meetings, open houses and public availability sessions, responding to telephone interviews, and/ or participation in focus groups.

The purpose of these community involvement activities is to provide a process for engaging in dialogue and collaboration with communities affected by Superfund sites. EPA community involvement is founded on the belief that people have a right to know what the Agency is doing in their community and to have a say in it. Its purpose is to give people the opportunity to become involved in the Agency's activities and to help shape the decisions that are made. Remedies that have community concerns and interests factored into them are less controversial and more likely to be accepted. Community involvement is the vehicle EPA uses to get community concerns and interests to the decision making table.

The Office of Emergency and Remedial Response, Office of Solid Waste and Emergency Response within the U. S. Environmental Protection Agency ( EPA) is responsible for implementing the Superfund program. EPA regions are responsible for oversight of State and local organizations' compliance with CERCLA and the NCP, including reporting and record keeping requirements.

EPA funds state activity at 90% from the CERCLA Hazardous Substances Response Trust Fund ( the Fund) for state lead activities via cooperative agreements with EPA as provided in CERCLA § 104( d)( 1)( 42 USC 9604( d)( 1)). States are not reimbursed from the Fund for identification of state sites and community members are not reimbursed for participation in community involvement activities. Despite the fact that community members are not reimbursed for their time, this ICR estimates the time costs imposed on community members who voluntarily participate in community activities tied to the Superfund process.

During the three year period covered by this ICR, EPA estimates that states will have the lead role at 30 sites that are in various stages of the remedial phase and that states will identify state ARARs at 120 sites. The total burden on state governments for the three year information collection period is estimated to be 503,730 hours at an estimated cost of $ 149,160 ( not including the costs reimbursed by the Federal government). EPA further estimates that community members will voluntarily incur a burden for participation activities equaling 53,850 hours at an estimated cost of $ 2,027,940 over the three year period of this ICR. 3 2. NEED FOR AND USE OF THE COLLECTION OF INFORMATION 2( a) Need/ Authority for the Collection of Information CERCLA authorizes the President to undertake removal and remedial actions in response to releases or threats of releases of hazardous substances and certain pollutants and contaminants into the environment. Revisions were made to the NCP in 1982 to incorporate the provisions of CERCLA. These revisions to the NCP established procedures for data collection, analysis, and reporting to be conducted during remedial and removal responses at Superfund sites. Subsequent revisions to the NCP in 1985 added additional procedures. Finally, the Superfund Amendments and Reauthorization Act of 1986 ( SARA) amended CERCLA and mandated, among other provisions, that the NCP be revised within 18 months of the date of enactment of SARA to incorporate provisions of the new law ( 42 USC 9605( b)). The revised NCP, published in March 1990, included new reporting and record keeping provisions for Superfund remedial responses.

EPA uses the information provided by the states to ensure state actions are consistent with the provisions of CERCLA and SARA and that their decisions are protective of human health and the environment. EPA uses the information gathered from private citizens to plan activities geared to educating them where necessary, keeping them informed of activities within the community, and ensuring they have had an opportunity to assume an active role in the decision making process that affects their community. EPA also uses information from private citizens to measure the effectiveness of community involvement activities and to improve those activities as needed. EPA believes involvement of the members of the community surrounding a Superfund site is critical to ensuring effective site cleanups.

There have been no statutory or regulatory revisions to applicable sections of the NCP since the previous ICR ( OMB Control No. 2050 0096). However, the previous information collection request for the NCP included estimates for the burden imposed on community members when providing feedback to EPA for purposes of the Government Performance and Results Act of 1993 ( GPRA). For the purposes of this ICR, however, EPA is not including an estimate for GPRA related reporting activities. This change emanates from the fact that community involvement activities are not part of the EPA's GPRA reporting requirements. Also, resources and time limits have shifted EPA's focus from GPRA evaluation activities to a focus on timely feedback of community involvement activities at specific sites. Therefore, this ICR contains an estimate for the burden imposed on community members when they provide feedback to EPA on community involvement activities but excludes a burden estimate for community involvementrelated GPRA reporting.

Most of the estimated burden in this ICR is for the information collection and record keeping required of states when they take the lead in remedial activities at Superfund sites. States, however, are not required to take on the role of the lead agency in remedial responses; rather, they choose to take on this responsibility and receive federal funding at 90% to compensate their efforts. A state may take the lead when EPA determines that a state's technical and oversight capabilities are adequate to ensure compliance with Federal standards ( 42 USC 9604( d)( 1)( A)). Furthermore, when states do take the lead role at NPL sites, they are reimbursed by the Fund for their work. The burden hours estimated in this ICR for state lead sites, therefore, represent responsibilities that states accept voluntarily and for which they are compensated. 4 The reporting and record keeping requirements imposed on states when taking a lead role is necessary to ensure that states perform remedial responses in a manner consistent with CERCLA and the NCP ( 42 USC 9604( d)( 1)( A)). States must identify state ARARs for each site in order to ensure that standards that are more stringent than Federal requirements are considered when selecting a remedy ( 42 USC 9621( d)). Community interviews are needed to prepare, and revise as necessary, a Community Involvement Plan ( CIP) for a site in order to ensure public involvement in site related decisions and provide appropriate opportunities for the community to learn about the site and to develop community groups to participate in site activities ( 42 USC 9617). Focus groups are needed to establish baselines and measure the results of various community involvement activities.

2( b) Use/ Users of the Data The lead agency, whether EPA or the state, conducts many data gathering activities, including development of the RI/ FS and the preparation of the Proposed Plan and the ROD. This data is used by the lead agency to make informed decisions regarding remedial responses. When states assume the lead responsibility, EPA Regions use the information collected to oversee states in the conduct of remedial responses at hazardous waste sites. Specifically, this information is used to ensure that remedies are selected in accordance with CERCLA and the NCP, that cleanup standards are attained, and that community concerns are appropriately addressed. The data are also made available to the public and may help community members understand health risks and participate in site related decisions.

States also identify state ARARs at all state and Federal lead sites during the RI/ FS. The ARARs are used to determine cleanup levels and to select the remedy to be used at a site.

Community interviews and information provided by community groups are used by the lead agency to ensure public involvement in site related decisions, as required by CERCLA and SARA, and provide appropriate opportunities for the community to learn about the site. EPA uses the information gathered through research instruments to obtain timely feedback on the community involvement process at the site level.

3. THE RESPONDENTS AND THE INFORMATION REQUESTED 3( a) Respondents The two categories of respondents for the activities addressed in this ICR are state governments and individuals ( i. e., community members surrounding Superfund sites). States are the only appropriate source for collecting, reporting, and maintaining data when they have the lead at NPL sites; community members are the only appropriate source for site specific public input, and for advising on whether EPA community involvement activities have been successful in providing understandable information and meaningful opportunities to participate in the process.

3( b) Information Requested ( I) Data Items This section describes the data items that must be reported or maintained by: ( 1) states at state lead sites; ( 2) states at all other sites; and ( 3) community members at all sites. 5 ( 1) State Activities at State Lead Sites At a state lead site, the state must conduct the following activities in order to be consistent with CERCLA:

Develop an RI/ FS;

Prepare a Proposed Plan;

Develop a ROD;

Prepare and update a CIP;

Prepare an engineering design fact sheet; and

Establish information repositories.

The Remedial Investigation and Feasibility Study The first step in conducting the RI/ FS, which is authorized under CERCLA § 104 ( 42 USC 9604( a)( 1); 40 CFR 300.430), is the development of a project plan, which describes the scope and content of the RI/ FS and includes work plans. Work plans are developed as part of the project plan and detail the site management strategy. The work plans identify initial boundaries of the study area, likely remedial response objectives, operable units ( if any), and the procedures that will be followed to satisfy the strategy. In addition, an initial site evaluation is presented in the typical work plan. This evaluation includes:

Site description;

Preliminary definition of the contamination problems;

Likely contaminant migration pathways;

Environmental and health effects associated with migration; and

Description of any initial remedial measures for the site.

A preliminary assessment of remedial alternatives may be included in the work plan. The data requirements necessary to support the selection of a remedy also are discussed.

Based on preliminary site information, the objectives and the scope of work for the RI and FS are developed. The scope of work for the RI includes many components, including plans for project operations that will be followed in conducting a survey of the study area, in characterizing the source of contamination, and in identifying Federal and state ARARs. The work plan also includes procedures that will be followed in evaluating contamination pathway and transport, and in evaluating the potential risk to public health posed by the site. Plans for testing the feasibility of remedial technologies also may be included. Initial data quality objectives, quality assurance procedures that will be followed, procedures to be followed in preparing the RI report, and information on the technical and financial management of the RI project also are discussed in the RI scope of work section of a site work plan.

The sampling and analysis plan for a site also is developed during the scoping phase of the RI. This plan describes the sampling, calibration, and analytical procedures that will be followed in collecting air, water, soil, and source samples. Quality assurance objectives to be met throughout the sampling task also are discussed. These objectives include procedures that will be followed to ensure the accuracy and precision of the analysis, as well as the completeness, representativeness, and comparability of the sampling. Hundreds of samples are taken during the typical RI, and the analysis of the site samples provides basic information on the concentration, source, and potential 6 paths of migration of contaminants at a site. Sampling and analysis plans generally include a project description that summarizes the site history, environmental setting, and project objectives such as the media to be sampled, sampling locations on the site, and sampling schedule. A health and safety plan also is drafted that identifies potentially hazardous operations and exposures, and prescribes appropriate protective measures.

In the scope of work for the FS, procedures are established for developing remedial alternatives for the site. Alternative screening and analysis procedures, methods for conducting a comparative evaluation of acceptable alternatives, and details on preparing the FS report also are included.

Concurrent with the preparation of the RI work plan, EPA conducts community interviews, as required by the NCP, in preparation for the required Community Involvement Plan, which must be finalized before any RI field work begins.

Upon completion and approval of the work plans and sampling and analysis plans, the RI/ FS can begin. The RI/ FS includes site work, analysis of data, and preparation of the RI report. Drilling and sampling detailed in the sample and analysis plan requires not only time spent at the site boring holes in the earth and taking air and water samples, but also time to mobilize drilling equipment and to train personnel in the sampling and decontamination techniques to be used at the site. Upon completion of the site work, the samples are sent to a laboratory for evaluation, and the results of the analyses are verified. Standard evaluation techniques include analyzing samples for organics, metals, and cyanide.

The RI serves as the mechanism for collecting data for site and waste characterization and for conducting treatability testing as necessary to: ( 1) evaluate the performance and cost of the treatment technologies considered for use at a site; and ( 2) support the design of selected remedies. The FS serves as the mechanism for the development, screening, and detailed evaluation of potential remedial alternatives. The RI and FS are conducted concurrently. Data collected in the RI influence the development of remedial alternatives in the FS, which in turn affects the data needs and scope of treatability studies and additional field investigations. The site characterization developed during the RI provides the data necessary to estimate the risks to human health and the environment posed by a site, to establish cleanup goals or ranges, and to identify viable cleanup alternatives. The FS draws upon the data collected and analyzed during the RI in the process of developing alternatives and conducting a detailed analysis of the most viable alternatives. Because of the interactive nature of this process, the sequence of the various phases and associated activities frequently will not be distinct in practice.

A risk assessment is conducted during the RI to estimate the health consequences of exposure to contaminants at a site. In this assessment, the physical and chemical properties of hazardous substances and their toxicological effects are studied to determine the potential for the substances to cause adverse health effects, and the likely pathways and magnitude of exposure of populations and/ or individuals near the site. An evaluation of dose response information also is completed to estimate the health effects ( e. g., incident of certain diseases) that may result from exposure to the hazardous or toxic substances at a site.

A risk characterization brings together the exposure and the dose response information to predict the likely range and severity of health effects that may occur as a result of the substances at a site, and the number of people affected. Included as an integral part of the risk assessment 7 process is the uncertainty evaluation, which identifies the degree of uncertainty associated with the final risk estimates by identifying uncertainties related to the data and the assumptions. This evaluation of uncertainties places bounds on the final estimate and targets areas needing improvement.

The FS process includes the initial evaluation and screening of a number of potential alternatives. Alternatives are eliminated from further evaluation for a number of reasons, including technical problems, lack of effectiveness in the long term or short term, failure to protect human health and the environment, cost, or implementation time. The universe of potential remedies is reduced to a reasonable number ( usually between three and five) of good alternatives on which detailed analyses are conducted. If existing site and treatment data are insufficient to evaluate the alternatives adequately, treatability tests may be necessary to evaluate a particular technology or specific site wastes. Treatability tests generally involve bench scale testing to assess the feasibility of a technology, although a pilot scale study may be required in a few situations.

Once sufficient data are available, alternatives are evaluated in detail with respect to nine evaluation criteria: protection of human health and the environment; compliance with ARARs; long term effectiveness and permanence; reduction of toxicity, mobility, or volume; short term effectiveness; implementability; cost; support agency acceptance; and community acceptance. The alternatives are evaluated individually against each criterion and then relative to other alternatives to understand completely the strengths and weaknesses of each alternative. At the end of this analysis process, the RI/ FS report is prepared.

For purposes of this analysis, EPA estimates that there will be, on average, 40 RI/ FS starts per year. It is estimated that a state will take the lead on ten new sites per year, on average, over the three year ICR period, and that the Federal government will take the lead on the remaining 30 sites per year. In this analysis, it is assumed that, for any given year, ten state lead sites will be in the first year of the RI/ FS process, ten will be in the second year, and ten will be in the final year, for a total of 30 state led sites per year in the RI/ FS process. This ICR does not address the burden on the Federal government for Federal lead activities in the RI/ FS process ( except to the extent that community activities are conducted). The cost to the Federal government of reviewing state lead site activities is addressed, and the full costs to the states are discussed.

The Proposed Plan The requirement to issue a Proposed Plan was added to the remedial process by SARA, ( 42 USC 9617( a); 40 CFR 300.430( f)( 2)). This document is to be prepared by the lead agency, in consultation with the support agency, at a site after completion of the RI/ FS report and prior to selection of a response action. The lead agency's primary objective in preparing and releasing the Proposed Plan is to seek public comment on the preferred alternative for addressing a problem at a site, and on the other alternatives discussed in the detailed analysis section of the RI/ FS.

The Proposed Plan is written using information from the RI/ FS report. The purpose of the Proposed Plan is to highlight the RI/ FS report, provide a brief analysis of remedial alternatives under consideration, identify a preferred alternative, and provide the public with information on how they can participate in the remedy selection process.

In developing the Proposed Plan, the lead and support agencies first review the RI/ FS 8 report prepared for a site, identify an initial preferred alternative, and prepare a draft Proposed Plan. The lead agency's management is briefed on the draft Proposed Plan, which is then forwarded to the support agency for comments. At the end of the support agency review period, the Proposed Plan is finalized and released to the public for comment.

CERCLA, as amended, also requires the lead agency to publish a brief notice and description of the Proposed Plan in a local newspaper of general circulation. As required by CERCLA § 117( a) ( 42 USC 9617( a)), this notice includes information sufficient to provide a reasonable explanation of the preferred alternative and the other alternatives studied. This notice will also announce the availability of the RI/ FS report and any planned public participation activities, especially the required Proposed Plan Public Meeting and 30 day comment period.

Finally, CERCLA § l17 requires the lead agency to offer the opportunity for a public meeting to discuss and answer questions and to obtain feedback about the RI/ FS report and the Proposed Plan. The lead agency establishes a date and time for the meeting, reserves a facility, and arranges for any special needs. The lead agency also designs the meeting program, including identifying specific issues and tasks to be addressed, preparing an agenda, identifying presenters, and rehearsing presentations. Printed materials, visual aids or graphics, and other materials are prepared and special arrangements made, such as hiring a court reporter. Finally, the meeting is held, and a transcript of the meeting notes is prepared by the lead agency. The transcript is made available to the public as required by CERCLA § 117.

In preparing the Proposed Plan, states are the lead agency for an estimated ten new sites per year and the Federal government is the lead agency for an estimated 30 sites per year. Only the full costs to the states, of conducting community activities and preparing a proposed plan, are discussed.

The Record of Decision The lead agency prepares a ROD in response to the statutory requirements in CERCLA § l13 ( 42 USC 9613) for a statement of basis and purpose of the selected remedy at a site and in CERCLA § 117 ( 42 USC 9617), which calls for a remedial action plan to be adopted and released to the public. The ROD is prepared by the lead agency in consultation with the support agency for a site. It is the decision document used to describe the selected remedy for a site or a particular component of a site ( e. g., geographic area, pathway, or source control), and to explain the rationale for the selected remedy. In addition, RODs demonstrate the lead agency's decisionmaking process has been carried out in accordance with CERCLA and the NCP. RODs typically have three major sections: the Declaration, the Decision Summary, and the Responsiveness Summary. All RODs are signed by EPA Regional Administrators or the Assistant Administrator for OSWER. In addition, a representative from a state may sign a ROD.

The Declaration is the formal statement ( signed by the EPA Regional Administrator or the Assistant Administrator of OSWER) which affirms that the selected remedy for a site is selected in accordance with CERCLA and is consistent, to the extent practicable, with the NCP. It provides a brief description of the selected remedy.

The Decision Summary is the focus of the ROD. The Summary begins with a brief discussion of the site history and a detailed site description, including: 9

Site area and topography,

Adjacent land uses;

Natural resource uses;

Distance to nearby populations;

General water resources, and

Surface and subsurface features.

Next, the history of state and Federal site investigations and CERCLA enforcement actions at the site are summarized. This historical summary is followed by a discussion of the community involvement activities that have been conducted for the site.

The Decision Summary then summarizes the scope of the response action and the site characteristics. The site characteristics section draws on information presented in the RI/ FS report and includes details on:

Types, quantity, and concentration of hazardous substances at a site:

All known or suspected sources of contamination;

All known or potential routes of migration, including the mobility, toxicity, and volume of waste;

Lateral and vertical extent of contamination at the site; and

Potential surface and subsurface pathways of migration.

Maps illustrating the location of units or contaminants and charts of contaminant types and concentrations often are used in the site characterization section of the Decision Summary. In addition, the results of the site risk assessment and any significant changes made to the preferred alternative in the Proposed Plan are summarized.

Another major component of the Decision Summary is the evaluation of the remedial alternatives considered for the site and identification of the selected remedy. The evaluation of alternatives section first presents a brief description of each of the remedial alternatives. Each alternative for which a detailed analysis was completed ( typically five) is discussed. These discussions include:

Summaries of the technology considered, such as in situ treatment, clean closure, or thermal treatment;

The type and quantity of waste to be contained or treated; and

The major ARARs and standards being met or utilized for specific components of the waste management process.

The estimated capital and O& M costs, as well as estimated implementation time of alternatives, also are presented. A comparative analysis is presented in which the remedial alternatives are evaluated based on the nine criteria described under the RI/ FS process and comments on the proposed plan. At the end of this analysis, the selected remedy is highlighted as a remedy that meets the statutory requirements of CERCLA and provides the best balance among the evaluation criteria.

The Decision Summary concludes with a detailed discussion of the selected remedy. The summary presents the risk levels to be attained after implementation of the remedy and summarizes the cleanup objectives for the different media at the site. Finally, the selected remedy 10 section of the Decision Summary demonstrates that the selected remedy complies with the statutory requirements in CERCLA § 121 ( 42 USC 9621), that is, the remedy will protect human health and the environment, attain Federal and state ARARs, be cost effective, and utilize permanent solutions and alternative treatment technologies or resource recovery technologies to the maximum extent practicable. A discussion of the extent to which the selected remedy fulfills the statutory preference for treatment that reduces the mobility, toxicity, or volume of the principal threats at a site also is presented in this section.

The final component of the ROD is the Responsiveness Summary, which is a requirement in CERCLA § 117 ( 42 USC 9617). This part summarizes the written and oral public comments received on the RI/ FS report, the Proposed Plan, and the administrative record and the lead agency's responses to each major category of comments. The Responsiveness Summary not only provides decision makers with information about community preferences regarding the remedial alternatives considered for a site, but also demonstrates to the public how their comments were taken into account as an integral part of the decision making process.

In preparing the Responsiveness Summary, background research is done to identify citizen input and concerns. In this process, transcripts of the public meeting on the RI/ FS report and the Proposed Plan are reviewed, major public comments are organized and summarized, and the lead agency's responses to these comments are prepared. The level of effort to be devoted to this section of the ROD varies, depending in part on the number, length, and complexity of comments and the number of policy issues outstanding at a site.

EPA estimates as many as 45 sites, on average, will issue a ROD each year and conduct the required community activities. It is estimated that ten of the sites issuing RODs each year will be state lead sites and that the remaining 35 sites will be Federal lead sites. It must also be noted here that, although CERCLA and SARA require only two community involvement activities in the post ROD stages of remedial design and construction, EPA's experience is that this is the most disruptive part of the process for the affected community and, therefore, the one most likely to draw intense public interest. EPA has found that it is in the Agency's best interests, as well as the public's, to continue its community involvement activities at the same level, if not at a higher level, as during the RI/ FS stage. Only the full costs to the states associated with conducting community activities and preparing the ROD are discussed.

Community Involvement Plan ( CIP)

Community Involvement Plans are developed at remedial sites to identify community concerns and to select techniques and approaches to use in addressing these concerns. The initial CIP developed for a site presents the community involvement program that is to be followed during the RI/ FS stage of the remedial phase. The NCP requires the CIP be completed and in place before field work begins for the RI. However, as the Agency seeks to accomplish RI field work during pre remedial actions to expedite cleanups, EPA is finding it necessary to begin its community involvement activity, including preparation of the CIP, very early in the pre remedial phase. The NCP also requires that EPA review its CIP prior to the Remedial Design/ Remedial Action phase, and make any changes necessary to accommodate changes in the community.

The initial steps in the preparation of CIPs involve conducting a review of the site and the surrounding community. Lead agency technical personnel summarize the problems at a site, the origins of those problems, and potential steps for addressing the problems. As part of this 11 process, lead agency files on the site are reviewed and local newspaper files are searched. Once a basic understanding of the site and previously performed activities is established, community involvement personnel from the lead agency conduct interviews with local community members to better determine community concerns and the level of community knowledge of site activities. In this process, a contact list is prepared, interviews are scheduled and conducted, and the results of the interviews are summarized. This process also includes the use of interviews for the purpose of establishing baseline measures of citizen concerns and attitudes from which changes can be measured, as well as to gain additional information that will help in the preparation of the CIP.

Once the background research is completed, a community involvement program is designed. This program may recommend such activities as distributing information brochures and fact sheets that explain Superfund program activities and the role of the lead agency in remediating Superfund sites. Small group meetings between lead agency staff, citizens, and local officials may be held to promote an informal exchange of ideas. To maximize the potential to bring about improvement in government services, EPA will utilize telephone interviews of fact sheet recipients and meeting attendees to assess the effectiveness of specific outreach products. EPA may also use focus groups to gather citizen input. At some sites, formal community groups are established that provide regular involvement and input to site activities.

Prior to commencement of the Remedial Design/ Remedial Action stage, the CIP is reviewed to determine whether it should be revised to address the community concerns at that time. In addition, GPRA requires that government plans be written as 5 year plans that are renewed every three years; this cycle will be followed at all active sites throughout the duration of remedial activities. The process for preparing the revised CIP is essentially the same as that followed in preparing the initial CIP:

Background research is conducted on activities that have occurred since the Plan was first written or last revised;

Community interviews are planned and conducted;

The community involvement program is revised to address the current citizen concerns; and

The CIP document is revised.

It is estimated that a CIP will be developed and/ or revised at not more than 120 sites each year, on average. It is estimated that ten of the sites developing new CIPs each year will be statelead sites, 30 sites developing new CIPs will be Federal lead sites, and the remaining 80 sites revising CIPs will be Federal lead sites. For the Federal government, only the costs of conducting the community activities and reviewing state lead site activities are addressed in this ICR. The full cost to the states, of conducting community activities and preparing and revising the CIP, as well as the costs to the public for participating in the process are discussed. 12 Engineering Fact Sheets In addition to developing a CIP, lead agencies must distribute a fact sheet explaining the final engineering design to the community and other interested parties. The fact sheet serves to inform the public about activities related to the final design, including the schedule for implementing the remedy, physical changes that may result in the site's appearance, and an explanation of the various agency roles. Site health and safety plans, emergency procedures, and any potential inconveniences that may occur also are explained. With the increasing number of sites moving into this stage of Superfund, EPA is experiencing an increase in public interest in the design and construction stages not previously anticipated. As the number of constructions increase, EPA anticipates a corresponding shift in the community involvement workload ( including fact sheets, etc.) from the pre ROD stages to the post ROD stages of design and construction.

It is estimated that 175 sites per year, on average, will distribute a fact sheet. It is estimated that ten of these sites will be state lead sites and that the remaining 165 sites will be Federal lead sites. Only the full costs to the states are discussed.

Information Repositories SARA amended CERCLA § 113 to require that an administrative record for the selection of remedy process be maintained in an information repository near each site and be made available to the public ( 42 USC 9613( l)). As a result, two records are compiled and maintained for each remedial response   one near the site and one in the offices of the lead agency or EPA region. Information repositories near a site include all publicly disclosed, site related documents. In developing the repositories, an appropriate location for the repository must be identified. This location must be publicly accessible. Then, documents to include in the repository must be maintained by updating information as necessary, and verifying the information is available that should be included in the repository. The information repository will be maintained as long as site remediation continues and for as long as is needed in the event there is litigation. Because remedial responses often last longer than three years, the record keeping associated with remedial responses typically will be maintained for more than three years.

EPA estimates 40 sites per year, on average, will set up an information repository. Ten of these sites are estimated to be state lead sites and the remaining 30 sites to be Federal lead sites. Only the full costs to the states are discussed.

( 2) States at All Other Sites SARA added a requirement to CERCLA § 121( d) ( 42 USC 9621( d)) that all remedial actions must be in compliance with promulgated state ARARs that are more stringent than Federal ARARs. To this end, the current revisions to the NCP require states to identify potential state ARARs for all Fund financed remedial actions ( i. e., an estimated 40 Federal and state lead sites). Potential state ARARs are to be identified as early in the RI/ FS process as possible.

( 3) Community Members at All Sites Section 300.430( c)( I) of the NCP requires the lead agency to conduct interviews with local officials, community residents, public interest groups, or other interested or affected parties 13 to solicit their concerns and information needs. The information gained during these interviews is used to develop the CIP, or to revise an existing one. Community members who elect to participate in interviews do not have to submit any particular data items, but may voluntarily disclose information and concerns. In addition, community members at some sites will form community groups that meet periodically and voluntarily provide advice and comment to the lead agency. EPA has learned that informal open houses and public information availability sessions are effective methods of providing information to the public and soliciting comments on site activities. For purposes of this analysis, EPA envisions that some degree of community participation will occur at as many as 175 different Federal and state lead sites annually. 1 This estimate allows for the combined effect of new sites ( 40), sites where formal community group activities take place ( 35), sites where community interviews are conducted for CIP revisions ( 80) and the additional sites where focus groups are held ( 20).

( II) Respondent Activities ( 1) State Activities at State Lead Sites In complying with reporting and Record keeping requirements at state lead sites, state employees may need to:

Read instructions;

Plan activities;

Receive training;

Gather information;

Conduct tests, investigations, and studies;

Write documents;

Process, compile, and review information for accuracy and appropriateness;

Complete written forms or other paperwork;

Substantiate claims of confidential business information;

Record and disclose information; and

Store, file, and maintain the information.

( 2) State Activities at All Other Sites In identifying ARARs, state employees may need to:

Gather information on new state laws and regulations;

Process, compile, and review information for accuracy and appropriateness;

Record and disclose information; and

Store, file, and maintain information.

( 3) Community Members at All Sites In participating in the remedial phase, community members may disclose information to Agency personnel during interviews. Community members may perform any or all of the following activities: 14

Participate in interviews;

Provide comments;

Attend informal and formal meetings, open houses, and public information availability sessions;

Participate in community groups;

Participate in focus groups; and

Respond to surveys.

4. INFORMATION COLLECTED  AGENCY ACTIVITIES, COLLECTION METHODOLOGY, AND INFORMATION MANAGEMENT 4( a) Agency Activities The Agency must provide oversight for all state activities when states have the lead in conducting Fund financed remedial activities. As part of its oversight role, the Agency may obtain, review, and maintain the information gathered by states. The Agency also reviews state ARARs at all Superfund sites. At Federal lead sites, the Agency conducts interviews, convenes formal and informal meetings, open houses, and public information availability sessions, distributes surveys and reviews results, and, in some cases, provides support to community groups.

4( b) Collection Methodology and Management Currently, states provide copies of documents relating to site activities at state lead sites and to ARARs for all sites to EPA Regional offices. EPA Regions review the documents to ensure that activities undertaken at state lead sites are consistent with the NCP. The regions also conduct public interviews and convene meetings for Federal lead sites. Regions develop written summaries from the interviews and meetings for use in developing the CIP. The summaries are stored in a case file maintained at the Regional office. For site specific feedback, EPA will use a combination of telephone interviews and focus groups.

The activities reflected in this ICR do not lend themselves to automation because of the decentralized nature of each remedial activity. These activities are site specific and, therefore, are not conducive to mass data collection efforts. The NCP does not specify a particular method of accomplishing information collection; the use of improved information technology is not prohibited in any way.

4( c) Small Entity Flexibility The reporting and record keeping activities addressed in this ICR do not affect small businesses. The remedial phase of the NCP does not impose any general information collection or Record keeping requirements on small businesses. The NCP does impose burdens on community members, but it is important to note the burden to individual community members is voluntarily accepted and, therefore, highly flexible.

4( d) Collection Schedule Information is not collected at any specified frequency, other than that already addressed; rather, it is collected as needed to assure the site action progresses in a timely fashion. 15 5. NON DUPLICATION, CONSULTATIONS, AND OTHER COLLECTION CRITERIA 5( a) Non duplication To the extent information already exists for a site, the lead agency is encouraged to use that information in conducting the RI/ FS and in developing RODs or Proposed Plans. In the past, there has been duplication of effort in collection of some site samples during the Site Investigation and during the subsequent RI. Duplication with other Federal data collection activities is expected to be minimal.

5( b) Consultations In addition to EPA regional offices, state representatives participated in the NCP workgroup meetings leading to the 1990 NCP revisions. State representatives provided guidance on how to avoid problems associated with implementation of the NCP requirements. The public and other Federal and state agencies also had the opportunity to submit comments on the proposed revisions to the NCP ( 53 FR 51394; December 21, 1988). These comments are addressed in the preamble to the final rule and in the Response to Comments document supporting the final rule.

Agency experience in addressing community issues has included semi annual or annual meetings with Regional community involvement staff, meetings with groups of states, and meetings with citizen groups.

5( c) Effects of Less Frequent Collection Other than noted above, information is not collected at any specified frequency, rather it is collected as needed to assure that site action progresses in a timely manner. The information collection frequencies in the NCP are the minimum amount necessary to have a remedial or removal program; information collection frequencies for community involvement feedback are the minimum required to gather meaningful information. Anything less would render the program ineffective and in violation of CERCLA.

5( d) General Guidelines States have at least 30 days in which to respond to any information requests specified in the NCP. This time frame is in compliance with the Paperwork Reduction Act guidelines. The record retention period for information repositories and administrative records are not specified explicitly in the NCP; rather, these records and repositories are to be maintained as long as necessary for litigation purposes and for the duration of remedial response at a site. Because remedial responses typically last longer than three years, records often will be maintained for more than three years.

5( e) Confidentiality and Sensitive Questions ( I) Confidentiality The nature of the data being gathered as part of this information collection is not 16 confidential. Information may be gathered from Potentially Responsible Parties ( PRPs) that the PRP considers to be Confidential Business Information ( CBI). When information is designated as CBI by a PRP, EPA follows restricted access procedures in handling the information. These procedures include keeping the information in locked areas and only allowing CBI cleared personnel access to the information. PRP information is gathered in anticipation of litigation. EPA, therefore, does not have to grant Freedom of Information Act requests for this information.

Lists of participants in community interviews and lists of attendees of public meetings are not confidential. Some data gathered during community interviews may not be releasable, however, due to privacy concerns.

( ii) Sensitive Questions The information gathering activities discussed in this ICR generally do not involve any sensitive questions. The Agency has found, however, that some information gathered during community interviews may be sensitive information with respect to privacy concerns.

6. ESTIMATED BURDEN AND COST OF THE COLLECTION OF INFORMATION 6( a) Respondent Unit Burdens ( Hours)

This section presents the burden of the NCP remedial program requirements to respondents in terms of the time ( in hours) spent to comply with the reporting and record keeping requirements. Respondents include states and the public. States incur an annual burden at a limited number of hazardous waste sites where they have responsibility for implementing remedial activities ( i. e., ten out of 30 sites). States also incur a burden for providing information on state ARARs at all 40 NPL sites where RI/ FSs are started. The public is also expected to incur an annual burden for community interviews and other community activities conducted in conjunction with the preparation of a CIP and other activities at each of the up to 175 sites, including the 40 NPL sites added to the remedial process on an annual basis ( i. e., both Federal and state lead sites). The annual burden to the Federal government to conduct community involvement activities at an estimated 175 Federal lead sites is also discussed.

The burden data in this section are based on estimates by EPA personnel knowledgeable of the remedial program's record keeping and reporting requirements and the costs and level of effort required to meet the requirements.

Estimated Unit Burdens to State Governments A " unit" burden is the burden incurred by a respondent for performing an individual sitespecific activity. States incur burdens at: ( 1) an estimated ten new state lead sites per year for several reporting and record keeping activities; and ( 2) all of the estimated 40 NPL sites on an annual basis with RI/ FS starts for identifying and reporting ARARs. At a state lead site, states incur a burden for the following activities:

Development of the RI/ FS;

Development of the Proposed Plan;

Preparation of the ROD;

Development of the CIP and 17

Providing information to the public.

The estimated average burden associated with each activity is discussed below and summarized in Exhibit 1.

The estimated burden associated with the RI/ FS process represents the number of hours that are spent conducting the data collection and analysis for the RI/ FS and for preparing the RI/ FS report. The RI/ FS process presently takes anywhere from 18 to 36 months, depending on the complexity of the site and the scope of the remedial activities being considered. It is estimated that the RI/ FS process takes an average of 33 months. EPA estimates that an average of 5,200 hours per year are necessary for a three year period ( i. e., a total of 15,600 hours) to complete the RI/ FS process. ( See Row 1 of Exhibit 1) For purposes of this analysis, it is assumed that these hours are incurred equally over the three year ICR period. The distribution of hours over the 33 month period may vary, and a burden will be incurred, on average, for a shorter period of time in the third year. However, this analysis assumes that, in any given year, ten state lead sites are in the first year of the RI/ FS process, ten in the second year, and ten in the third, and final, year, for a total of 30 state lead sites in the RI/ FS process over the three years covered by this ICR. Therefore, the distribution of hours over the 33 month RI/ FS period will not affect the total annual burden for all sites. Because the RI/ FS burden is averaged over a three year duration of the activity, the unit burden shown in Exhibit 1 is incurred annually at the 30 sites at which an RI/ FS is being conducted.

Other activities at state lead sites are incurred during a one year period at each site, and therefore are only performed at ten new sites annually. These activities include preparing the Proposed Plan, developing the ROD, preparing the initial CIP, revising the CIP, preparing an engineering design fact sheet, and establishing information repositories.

The Agency estimates that preparation of the Proposed Plan and related activities, including the newspaper notification, will require a total of 80 hours per site per year. ( See Row 2 of Exhibit 1) EPA estimates that preparing the Proposed Plan itself will require 70 hours. This estimate is based on program experience in preparing fact sheets for remedial sites, and is applicable to the Proposed Plan because it may be released in fact sheet format. The Agency estimates that ten hours will be necessary to prepare the newspaper notification on the Proposed Plan required by CERCLA. This estimate is based on program experience in preparing such notifications.

EPA estimates that it will require 360 hours to prepare a ROD and provide public notification. ( See Row 3 of Exhibit 1) Historical program experience indicates that approximately 350 hours are devoted to preparing a ROD. An additional ten hours are estimated to be necessary for preparing the newspaper notification of the ROD required by statute.

EPA estimates that an average of 150 hours is required to prepare the initial CIP and 150 hours are required to revise it later in the remedial process. ( See Rows 4 and 5 of Exhibit 1) These estimates are based on program experience. The estimate includes time to conduct initial background reviews of the site and community activities, plan and conduct community interviews, prepare for and attend community meetings as necessary, and prepare the initial CIP and revised CIP. EPA estimates the preparation and subsequent revision of the CIP occurs over a three year period, with the initial CIP prepared during the first year, and the revised CIP prepared during the third year. 18 Other community involvement activities include two additional requirements for providing information to the public: ( 1) preparing an engineering design fact sheet and ( 2) creating information repositories. Preparation of the engineering design fact sheet is estimated to require 70 hours of time per site. ( See Row 6 of Exhibit 1) Based on program experience, EPA estimates that 40 hours will be required to maintain both of the administrative records ( i. e., one record at the site and one at the lead agency). ( See Row 8 of Exhibit 1) These hours include time necessary to determine an appropriate location for the on site record, to identify, reproduce and deposit documents, and to maintain the records.

States incur a burden at all Superfund sites, both state lead ( ten per year) and Federal lead EXHIBIT 1 ESTIMATED ANNUAL BURDEN AND COST TO STATES Activity Unit Burden ( Hours) Unit Labor Cost1 ( Dollars) Other Unit Costs2 ( Dollars) Total Unit Cost ( Dollars) Average Number of Units per Year3 Total Burden ( Hours) Total Cost ( Dollars)

RI/ FS 5,200 [ 255,060] [ 50,231] [ 305,291] 30 156,000 [ 9,158,730]

Proposed plan 80 [ 3,013] [ 1,552] [ 4,565] 10 800 [ 45,650]

ROD 360 [ 13,558] [ 463] [ 14,021] 10 3,600 [ 140,210]

Initial CIP 150 [ 5,649] 0 [ 5,649] 10 1,500 [ 56,490]

Revised CIP 150 [ 5,649] 0 [ 5,649] 10 1,500 [ 56,490]

Participation in community group activities 112 [ 4,230] 0 [ 4,230] 10 1,120 [ 4,724]

Participation in focus groups 17 [ 640] 0 [ 640] 10 170 [ 6,402]

Fact sheets 70 [ 2,636] [ 2,112] [ 4,748] 10 700 [ 47,480]

Public briefing 80 [ 3,013] [ 371] [ 3,384] 10 800 [ 33,840]

Information repositories 40 [ 1,506 ] [ 1,256] [ 2,762] 10 400 [ 27,620 ARARs 33 1,243 0 1,243 40 1,320 49,720 Subtotal 167,910 9,627,356 Reimbursement from Federal Government n/ a [ 9,577,636]

TOTAL ( includes record keeping activities) 167,910 49,720 [ ] Brackets indicate costs that are reimbursed by the Federal government. Because the costs are reimbursed, they are not incurred by the State government. The reimbursed costs are indicated here to help determine the costs incurred by the federal government for Site activities at Statelead sites.

( 30 per year), for identification of state ARARs. EPA estimates that site specific determinations of potential state ARARs will require 33 hours per site. ( See Row 9 of Exhibit 1) 19 For purposes of this analysis, it is estimated that 10 percent of the total burden to states is attributed to record keeping activities and 90 percent is attributed to reporting activities.

Estimated Unit Burdens to Community Members The estimated unit burden for community members is summarized in Exhibit 2. As discussed above, there are several levels of activity that may be associated with community involvement at a Superfund site. For all Superfund sites, there is a voluntary burden associated with initial community interviews, review of and comment on various EPA documents, participation in focus groups, and additional community interviews associated with revisions to the CIP. These activities are conducted to identify major community concerns and to provide community members with meaningful opportunities to participate in decisions that affect them. The burden of these activities is the same for both state lead and Federal lead sites. The burden, which is voluntarily accepted by community members, is estimated based on the number of participants and the estimated number, and frequency, of the community activities or meetings:

Completion of written questionnaires regarding community involvement effectiveness at specific sites   15 minutes each, an estimated 300 completed questionnaires for a total burden of 75 hours per site;

Initial community interviews   20 people per site multiplied by 2 hour per interview for a total burden of 40 hours per site.

Community interviews for revision to CIP   20 people per site multiplied by 2 hour per interview, for a total burden of 40 hours.

Participation in focus groups   15 people per site multiplied by 2 hours per group session for a total burden of 30 hours per participating site.

This results in a total annual burden to community members for most Superfund sites ranging from 155 ( 75+ 40+ 40) to 185 ( 155+ 30) hours of citizen time per year, with an average of 170 hours ( 155+ 185/ 2). However, for certain Superfund sites, there is an additional burden associated with participation in formal community group activities ( e. g., participation in Community Advisory Groups ( CAGs) or in obtaining technical assistance). These efforts are estimated to involve, on average, 20 people per meeting multiplied by 4 meetings per year multiplied by 2 hours per meeting for a total unit burden to community members for this activity of 160 hours. Thus, for approximately 10 percent of Superfund sites, with study, design or construction underway, the total annual burden to community members is 315 ( 75+ 40+ 40+ 160) to 345 ( 75+ 40+ 40+ 160+ 30) hours with the average being 330 hours ( 315+ 345/ 2) per site. 20 EXHIBIT 2 ESTIMATED ANNUAL BURDEN AND COST TO COMMUNITY MEMBERS Activity Unit Burden ( Hours) Unit Labor Cost4 ( Dollars) Other Unit Costs ( Dollars) Total Unit Cost ( Dollars) Average Number of Units per Year5 Total Burden ( Hours) Total Cost6 ( Dollars)

Completion of questionnaires 75 2,825 0 2,825 10 750 28,250 Initial community interviews 40 1,506 0 1,506 40 1,600 60,256 Community interviews for revision to CIP 40 1,506 0 1,506 80 3,200 120,480 Participation in focus groups 30 1,130 0 1,130 40 1,200 45,200 Participation in community group activities 160 6,025 0 6,025 70 11,200 421,792 TOTAL 17,950 675,980 6( b) Respondent Unit Costs A " unit" cost is the cost incurred by a respondent in performing an individual, site specific activity. In developing estimates of the costs to state governments and to respondents, a weighted hourly wage rate is used. This wage rate reflects the assumption that the total number of hours necessary for completing any of the record keeping or reporting activities analyzed here are divided among three labor categories as follows: ten percent of total hours are allocated to managerial staff for their direction of and review of activities; 80 percent of the total hours are allocated to technical staff for conducting the majority of the preparation activities; and the remaining 10 percent of the total labor hours are allocated to support staff for their preparation of documents.

For all of the activities covered by this ICR except RI/ FS activity, wage rates for state government personnel are estimated to be comparable to those for Federal government personnel. Labor rates for government workers reflect the median GS level salaries for managerial, technical, and clerical positions. These rates include direct salary and fringe benefits ( calculated at 60 percent of direct salary). The hourly rates, as of January 2001, are:

Management ( GS 13, Step 5) $ 49.82/ hour; Technical ( GS 11, Step 5): $ 34.96/ hour; and Clerical ( GS 7, Step 5) $ 23.61/ hour.

Based on the above, the weighted hourly wage rate for state and Federal personnel is $ 37.66 [( 0.1)*($ 49.82) + ( 0.8)*($ 34.96) + ( 0.1)*($ 23.61)] dd 21 For RI/ FS activity, a higher weighted hourly wage is used, $ 49.05. The basis for this higher rate is that a substantial amount of RI/ FS work is performed by contractual labor which commands a higher hourly rate reflecting the direct labor, labor overhead, other direct costs, provisional hourly fees and other fees. The weighted hourly wage rate for RI/ FS work is $ 49.05 [( 0.1)*($ 37.66) state oversight + ( 0.9)*( 50.32) average hourly contractual rate].

For purposes of this analysis, the same wage rate is used when valuing the time of community members who participate in community outreach activities.

The annual unit cost of labor for each activity is presented in Exhibits 1 and 2. The labor unit cost of any activity for state governments or community members is determined by multiplying the unit burden estimate by the appropriate wage rates. For example, it is estimated that a state will incur an average burden of 5,200 hours annually at a state lead site for development of the RI/ FS. Therefore, the annual labor cost of preparing the RI/ FS is $ 255,060 [( 5,200 hours)*($ 49.05)].

Many activities include costs other than labor costs. These other costs are displayed in Column 3 of Exhibit 1. EPA estimates that the following capital and other costs are necessary to complete each activity:

$ 150,695 to develop the RI/ FS, at an average annual cost of $ 50,231 ( includes the cost of equipment purchased to conduct site work, such as drill casings, and the cost of sampling and analysis);

$ 1,552 to prepare the Proposed Plan ( includes costs specific to printing, distribution, and purchasing newspaper advertising space);

$ 463 to develop a ROD ( includes the costs of producing and printing documents and purchasing newspaper advertising space);

$ 2,112 to prepare fact sheets describing the final engineering design ( includes the costs of printing and distributing the document); and

$ 1,256 to establish information repositories ( for copying and obtaining storage space).

The total unit cost is determined by adding the unit labor cost to the unit capital cost. For example, the total unit cost to develop the RI/ FS is $ 305,291 [($ 255,060) in labor costs) + ($ 50,231 in annual capital and other costs)].

Although states conduct the activities at state lead sites, they are reimbursed by the Federal government for certain activities and, therefore, do not incur any costs for these activities at these sites. However, the Federal government will incur the costs of state activities, and these costs are analyzed later in this ICR. Consequently, the estimated costs of state activities are included in brackets in Exhibit 1 in order to establish the basis for determining the cost to the Federal government in the next section of this ICR.

It is estimated that identification of ARARs by a state at any Superfund site, which is not reimbursed by the Federal government, costs a state $ 1,243 per site. The cost of identifying state ARARs represents labor costs only, it does not include any capital or other costs.

The estimated cost for community member participation in a combination of activities relating to a remedial decision at a Superfund site is $ 7,043 per site for most sites ($ 2,825 for answering written questionnaires; $ 1,544 for initial community interviews; and $ 1,544 for 22 interviews associated with revisions to the CIP; $ 1,130 for participation in focus groups); and $ 11,900 for those sites where a community group is formed ( including $ 4,857 for participation in community group activities). Community members are not expected to incur any capital or other costs to participate in community activities. The unit costs for the community member activities are presented in Exhibit 2.

6( c) Estimated Agency Unit Burdens and Costs This section estimates the unit burdens and costs to the Federal government for overseeing the NCP reporting and record keeping activities. The annual costs to the Federal government estimated here are the costs of obtaining, reviewing, and maintaining the information gathered from states when they have the lead in conducting Fund financed remedial activities or are fulfilling other reporting or record keeping requirements under the NCP. Specifically, the Agency incurs costs associated with: ( 1) conducting community involvement activities at Federallead sites; ( 2) overseeing states' remedial activities at state lead sites; and ( 3) reviewing ARARs at all NPL sites with RI/ FS starts.

The unit burdens and costs for the Agency are presented in Exhibits 3 and 4. Exhibit 3 presents the unit burden and costs associated with conducting community involvement activities at Federal lead sites. As for the burden to community members, the burden to the Federal government is estimated based on the number of EPA participants and the estimated number, and frequency, of the community activities or meetings:

Preparation and analysis of written questionnaires   requiring an estimated 800 surveys to receive 300 completed questionnaires: 800 mailings prepared ( i. e., folded and placed in envelopes) @ 1 min each ( 13 hours) plus 40 hours to compile and analyze data and prepare reports for a total of 53 hours.

Initial community interviews  20 interviews per site multiplied by 2 EPA/ contractor personnel multiplied by 2 hour per interview ( 80 hours) plus 1 hour of preparation/ follow up time per EPA/ contractor personnel per interview ( 40 hours) for a total burden of 120 hours per site.

Community interviews for revision to CIP 20 completed interviews per site multiplied by 2 EPA/ contractor personnel multiplied by 2 hour per interview and one hour for preparation for a total burden of 120 hours.

Participation in focus groups   5 hours for preparation + 12 hours ( 2 people multiplied by 2 hours per session multiplied by 3 sessions) for a total of 17 hours.

These activities result in a total annual burden for community activities at most Federallead sites of 310 hours ( 120+ 53+ 120+ 17) per year per site. For those Federal lead sites with formal community group activities, however, the total annual burden per site is estimated to be 422 hours ( 310+ 112). The additional burden associated with participating in community group activities is based on the expectation that, on average, 2 Federal personnel attend 4 activities per year each requiring 4 hours ( i. e., 2 hours of meeting time and 2 hours of preparation time). In addition, the 4 meetings are estimated to require an additional 20 hours of planning time each. This results in an additional burden of 112 hours per site for those Federal lead sites with formal community group activities. 23 EXHIBIT 3 ESTIMATED ANNUAL BURDEN AND COST TO FEDERAL GOVERNMENT FOR COMMUNITY INVOLVEMENT ACTIVITIES AT FEDERAL LEAD SITES Activity Unit Burden ( Hours) Unit Labor Cost7 ( Dollars) Other Unit Costs ( Dollars) Total Unit Cost ( Dollars) Average Number of Units per Year8 Total Burden ( Hours) Total Cost9 ( Dollars)

Preparation and analysis of written questionnaires 53 2,000 0 2,000 10 530 20,000 Initial community interviews 120 4,519 0 4,519 40 3,600 135,576 Community interviews for revision of CIP 120 3,013 0 3,013 80 6,400 241,040 Participation in focus groups 17 640 0 640 40 1,360 51,218 Participation in community group activities 112 4,217 0 4,217 70 7,840 295,254 TOTAL 19,730 743,032 Unit costs are arrived at by multiplying the unit burden estimate by the weighted wage rate of $ 37.66/ hour. The total unit cost to the Federal government of conducting community activities is $ 9,151 for most sites ($ 4,519 for initial community interviews; $ 979 for telephone interviews of fact sheet recipients; $ 640 for participation in focus groups and $ 3,013 for interviews associated with revisions to the CIP and $ 13,369 for those sites where a community group is formed ( including $ 4,218 for participation in community group activities).

Exhibit 4 presents the unit burden and cost to the Federal government associated with Federal oversight of state lead sites and with review of state ARAR determinations. Federal oversight of state activities is assumed to require 10 percent of the total annual burden hours for states to perform each activity. Therefore, the unit burdens are determined by multiplying the state burdens for each activity by a factor of 10 percent. Unit costs are determined by multiplying the unit burdens by the weighted wage rate of $ 37.66/ hour. For example, it is estimated that a state government will spend an average of 5,200 hours annually to conduct the RI/ FS at a state lead site. The Agency, therefore, is estimated to spend an average of 520 hours [( 5,200 hours)*( 0.1)] overseeing the state's RI/ FS process and reports at an average annual cost of $ 19,583 per site [( 520 hours)*($ 37.66/ hour)]. 24 EXHIBIT 4 ESTIMATED ANNUAL BURDEN AND COST TO FEDERAL GOVERNMENT FOR OVERSIGHT OF STATE LEAD SITES Activity Unit Burden10 ( Hours) Unit Labor Cost11 ( Dollars) Other Unit Costs ( Dollars) Total Unit Cost ( Dollars) Average Number of Units per Year12 Reimbursement Cost ( Dollars) Total Burden ( Hours) Total Cost13 ( Dollars)

Federal oversight of Activities at State Lead Sites RI/ FS 520 19,583 0 19,583 30 9,158,730 15,600 9,746,226 Proposed plan 8 301 0 301 10 45,650 80 48,663 ROD 36 1,356 0 1,356 10 140,210 360 153,768 Initial CIP 15 565 0 565 10 56,490 150 32,259 Revised CIP 15 565 0 565 10 56,490 150 32,259 Participation in community group activities 11 414 0 414 10 4,140 110 4,142 Participation in focus groups 2 75 0 75 10 750 20 753 Fact sheets 7 264 0 264 10 47,480 70 50,116 Information repositories 4 151 0 151 10 27,620 40 29,126 Review of State ARARs Determination 3 113 0 113 40 0 120 4,520 Community Activities at Federal lead Sites 0 19,730 743,032 TOTAL 9,537,560 36,430 10,844,864 25 6( d) Total Burden for Respondents and the Agency Total Estimated Burden and Cost to State Governments The total estimated burden and cost to state governments for reporting and record keeping activities at all applicable sites depend on the number of such activities that are performed annually. The burden estimated here is based on the assumption that the new average of six statelead RI/ FS starts each year will be maintained over the period of this ICR. Furthermore, because this ICR is a renewal of a previously estimated burden, it is further assumed that several state lead RI/ FSs are already in process as of the start of this ICR period ( i. e., some RI/ FSs are in their second year and others in their third and final year). Thus, as discussed above, for each year of this ICR, it is estimated that there are 30 state lead sites that are in the RI/ FS stage: ten state lead starts, ten sites where RI/ FS activities are in their second year, and ten sites where RI/ FS activities are in their third and final year. Because the RI/ FS burden is averaged over a three year duration of the activity, the unit burden shown in Exhibit 1 is incurred annually at the 30 sites at which an RI/ FS is being conducted. As mentioned above, other activities at state lead sites are incurred during a one year period at each site, and therefore are only performed at ten sites annually. These activities include preparing the Proposed Plan, developing the ROD, preparing the initial CIP, revising the CIP, preparing an engineering design fact sheet, and establishing information repositories.

The total estimated burden to state governments is determined by multiplying the unit burden estimate, ( shown in Exhibit 1) by the number of units ( i. e., the number of times an activity is performed each year). For example, the annual unit burden for a state to develop an RI/ FS is 5,200 hours. As discussed above, it is estimated that states are developing an RI/ FS at 30 sites during any given year. Consequently, the total annual burden to all states for the RI/ FS process is 156,000 hours [( 5,200 hours/ site)*( 30 sites)]. For purposes of this analysis, it is estimated that 10 percent of the total burden is attributed to record keeping activities and 90 percent is attributed to reporting activities.

The total estimated cost to state governments is determined by multiplying the total unit cost estimate ( shown in Exhibit 1) by the number of units. The only cost that is incurred by a state is identification of ARARs because that cost is not reimbursed by the Federal government. However, the estimated total costs of reimbursable state activities are included in brackets in Exhibit 1 in order to establish the basis for determining the cost to the Federal government. For example, the total unit cost for a state to develop an RI/ FS is estimated to be $ 305,291. As discussed above, it is estimated that states are developing an RI/ FS at 30 sites during any given year. Consequently, the total annual cost to all states for the RI/ FS process is $ 9,158,730 [($ 305,291/ site)*( 30 sites)]. This amount is an estimate that must be annually reimbursed to state governments from the Fund for RI/ FS activities. This cost is included as a cost to the Federal government in Exhibit 4.

The total annual cost to all states for identifying state ARARs at 40 sites is estimated to be $ 49,711 [($ 37.66/ hour)*( 33 hours/ site)*( 40 sites)].

Total Estimated Burden and Cost to Community Members The total estimated burden and cost to community members for reporting activities ( i. e., participating in interviews, formal community groups, and the phone interviews and focus groups 26 associated with site specific program evaluation efforts) depend on the number of such activities that are performed annually. There are no record keeping activities for community members.

The total burden and cost to community members are shown in Exhibit 2. As discussed above, EPA estimates that initial community interviews take place at 40 sites, interviews associated with revisions to the CIP take place at all 80 sites and activities associated with participation in community groups occur at 70 sites. These figures include an assumption that the site specific feedback activities of telephone interviews and focus groups will take place at up to 10 sites. The total annual burden to community members is estimated to be 1,600 hours for initial interviews; 3,200 hours for interviews associated with revisions to the CIP; and 11,200 hours for activities associated with participation in community groups. The total annual cost to community members is $ 60,256 for participating in initial interviews, $ 120,480 for interviews associated with revisions to the CIP, and $ 421,792 for activities associated with participation in community groups, $ 28,250 to complete the written questionnaires, and $ 45,200 to participate in the focus groups. The total annual cost to the community for all activities at Superfund sites is $ 675,980. It must be noted that these costs are an attempt to value private citizens' time; since private citizens participate voluntarily during their free time, time costs are the only costs incurred; there are no out of pocket expenses for citizens.

Total Estimated Burden and Cost to the Federal Government The total annual burden and cost to the Federal government are presented in Exhibits 3 and 4. The Federal government incurs costs not only for its labor in conducting community involvement at Federal lead sites, providing oversight at state lead sites, and reviewing state ARARS, but also for reimbursing state governments for their activities at state lead sites ( the reimbursement costs are derived in Exhibit 1 under the costs to state governments). Total annual burdens and costs are determined by multiplying the unit burdens and costs by the number of units performed each year. As shown in Exhibit 3, the total annual burden and cost to the Federal government for community activities at Federal lead sites are 19,730 hours and $ 743,032 respectively.

Exhibit 4 shows the total burden and total cost estimates for Federal oversight activities. and review of State ARARs. Because EPA is providing oversight for state lead actions, the number of units is identical to the number of units performed by the states. The total annual burden to the Agency for oversight activities and review of state ARARs is 16,700 hours. The total annual cost to the Agency for this oversight is $ 628,922 [( 16,700 hours) * ($ 37.66/ hours)]. The total annual cost to the Fund for reimbursing state governments is estimated to be $ 9,577,636.

The total annual burden and cost to the Federal government for conducting community involvement at Federal lead sites ($ 743,032), oversight at state lead sites ($ 10,097,312), review of state ARARs ($ 4,520), and reimbursing state governments for their activities at state lead sites ($ 9,577,636) are $ 20,422,500. 27 Total Estimated Burden and Cost to All Respondents and the Federal Government The estimated total annual burden and cost to all respondents are presented in Exhibit 5. The total burden to all respondents over the three year ICR period is 557,580 hours. The total cost to all respondents over the three year ICR period is $ 2,177,100.

EXHIBIT 5 TOTAL ANNUAL COST AND BURDEN Respondents Cost Burden ( Hours)

States $ 49,720 167,910 Community Members $ 675,980 17,950 Total $ 725,700 185,860 Federal Government $ 20,422,500 36,430 6( e) Reasons for the Change in Burden The estimated annual to respondents ( i. e., state governments and community members) increased by 72,370 hours from the previous ICR ( from 113,490 hours to 185,860 hours). This increase is primarily attributable to the increase in the number of sites to be added to the NPL over the three year period of this ICR as compared to the number of NPL sites covered by the previous ICR and revisions to the community involvement estimates based on an update of the activities conducted and the burden imposed by those activities.

6( f) Burden Statement The average public reporting burden for a state government that has the lead at a Superfund site is estimated to be 5,474 hours per site. This reporting burden includes the time required to review instructions, search existing data sources, gather and maintain the data needed, estimate the information required, and complete and review the collection of information. The average record keeping burden for a state government that has the lead at a Superfund site is estimated to be 609 hours per site.

The average public reporting burden for community members is estimated to range from, 155 hours to 345 hours, with an average burden of 250 hours per site. This reporting burden includes time required to participate in community group activities and participate in community interviews. There is no record keeping burden for community members.

An announcement was published in the Federal Register on March 9, 2001, informing the public that EPA was planning to seek renewal of this ICR from the Office of Management and Budget. The announcement solicited comments on specific aspects of the proposed information collection; EPA received no comments from the public.

These reporting and record keeping burden estimates are based on the average burden for 28 1. Labor costs for all activities except RI/ FS are based on a weighted hourly wage rate of $ 37.66. The labor rate for RI/ FS activity is a weighted hourly wage rate of $ 49.05. This higher rate reflects the cost of contractual labor and state oversight costs. ( See p. 20.)

2. Other costs may include capital costs and other direct costs such as: equipment purchased to conduct site work, printing, copying, storage space, and newspaper advertising space.

3. The average number of units represents the number of times an activity is performed by state governments each year. The annual estimate used in this analysis is an average number for the three year ICR period and may not represent the actual distribution of activities over the three year period. In this analysis, it is assumed that, for any given year, ten State lead sites will be in the first year of the RI/ FS process, ten will be in the second year, and ten will be in the final year, for a total of 30 sites per year.

4. Labor costs are based on a weighted hourly wage rate of $ 37.66. ( See p. 20.)

5. The average number of units represents the number of sites at which an activity is performed by community members each year. The annual estimate used in this analysis is an average number for the three year ICR period and may not represent the actual distribution of activities over the three year period.

6. Totals may not add exactly due to rounding.

7. Labor costs are based on a weighted hourly wage rate of $ 37.66. ( See p. 20.)

8. The average number of units represents the number of times an activity is performed by community members each year. The annual estimate used in this analysis is an average number for the three year ICR period and may not represent the actual distribution of activities over the three year periods.

9. Totals may not add exactly due to rounding.

10. Unit burden estimates for each activity are based on an annual average burden. Some activities are performed over a period of greater than one year and the burdens associated with such activities are not necessarily uniform over the duration of the activity.

11. Labor costs are based on a weighted hourly wage of $ 37.66. ( See p. 20.)

12. The average number of units represents the number of times an activity is performed by the Agency each year. The annual estimate used in this analysis is an average number for the three year ICR period and may not represent the actual distribution of activities over the three year period.

13. Total may not add exactly due to rounding. the 3 year period covered by this ICR. Send comments regarding this collection of information, including suggestions for reducing the burden, to: Director, Collection Strategies Division, U. S. Environmental Protection Agency ( 2822), 1200 Pennsylvania Ave., NW, Washington, D. C. 20460. Include the OMB control number in any correspondence.

End Notes


[Federal Register Volume 76, Number 129 (Wednesday, July 6, 2011)]
[Notices]
[Page 39405]
[FR Doc No: 2011-16859]

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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2011-N-0002]

Blood Products Advisory Committee; Notice of Meeting

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice.

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    This notice announces a forthcoming meeting of a public advisory
committee of the Food and Drug Administration (FDA). The meeting will
be open to the public.
    Name of Committee: Blood Products Advisory Committee.
    General Function of the Committee: To provide advice and
recommendations to the Agency on FDA's regulatory issues.
    Date and Time: The meeting will be held on August 2, 2011, from
1:30 p.m. to 5 p.m. and on August 3, 2011, from 8 a.m. to 2:30 p.m.
    Location: Hilton Hotel, Washington, DC North Gaithersburg, 620
Perry Pkwy., Gaithersburg, MD 20877,<PHONE_NUMBER>. For those unable to
attend in person, the meeting will also be Web cast. The Web cast will
be available at the following links.
    Blood Products Advisory Committee Day 1: http://fda.yorkcast.com/webcast/Viewer/?peid=b6ce0d080a594ddf9d362a0b1815b4491d.
    Blood Products Advisory Committee Day 2: http://fda.yorkcast.com/webcast/Viewer/?peid=68d4630cf50847c5aaec06b1720f205f1d.
    Contact Person: Bryan Emery or Rosanna Harvey, Center for Biologics
Evaluation and Research (HFM-71), Food and Drug Administration, 1401
Rockville Pike, Rockville, MD 20852,<PHONE_NUMBER>, or FDA Advisory
Committee Information Line, 1-800-741-8138<PHONE_NUMBER> in the
Washington, DC area), and follow the prompts to the desired center or
product area. Please call the Information Line for up-to-date
information on this meeting. A notice in the Federal Register about
last minute modifications that impact a previously announced advisory
committee meeting cannot always be published quickly enough to provide
timely notice. Therefore, you should always check the Agency's Web site
and call the appropriate advisory committee hot line/phone line to
learn about possible modifications before coming to the meeting.
    Agenda: On August 2, 2011, the committee will discuss a study on
the incidence of Trypanosoma cruzi infection in blood donors and its
implications for selective testing of blood donors. On August 3, 2011,
the committee will discuss measures to preserve the blood supply during
a severe emergency. In the afternoon, the committee will hear the
following updates: Summary of the June 7-8, 2011, Health and Human
Services Advisory Committee on Blood Safety and Availability meeting;
summary of the May 17-18, 2011, public workshop on risk mitigation
strategies to address procoagulant activity in immune globulin
products; and summary of the August 1-2, 2011, Transmissible Spongiform
Encephalopathies Advisory Committee meeting.
    FDA intends to make background material available to the public no
later than 2 business days before the meeting. If FDA is unable to post
the background material on its Web site prior to the meeting, the
background material will be made publicly available at the location of
the advisory committee meeting, and the background material will be
posted on FDA's Web site after the meeting. Background material is
available at http://www.fda.gov/AdvisoryCommittees/Calendar/default.htm. Scroll down to the appropriate advisory committee link.
    Procedure: Interested persons may present data, information, or
views, orally or in writing, on issues pending before the committee.
Written submissions may be made to the contact person on or before July
26, 2011. Oral presentations from the public will be scheduled on
August 2, 2011, between approximately 3:30 and 4 p.m. and on August 3,
2011, between approximately 11 and 11:30 a.m. Those individuals
interested in making formal oral presentations should notify the
contact person and submit a brief statement of the general nature of
the evidence or arguments they wish to present, the names and addresses
of proposed participants, and an indication of the approximate time
requested to make their presentation on or before July 18, 2011. Time
allotted for each presentation may be limited. If the number of
registrants requesting to speak is greater than can be reasonably
accommodated during the scheduled open public hearing session, FDA may
conduct a lottery to determine the speakers for the scheduled open
public hearing session. The contact person will notify interested
persons regarding their request to speak by July 19, 2011.
    Persons attending FDA's advisory committee meetings are advised
that the Agency is not responsible for providing access to electrical
outlets.
    FDA welcomes the attendance of the public at its advisory committee
meetings and will make every effort to accommodate persons with
physical disabilities or special needs. If you require special
accommodations due to a disability, please contact Bryan Emery or
Rosanna Harvey at least 7 days in advance of the meeting.
    FDA is committed to the orderly conduct of its advisory committee
meetings. Please visit our Web site at http://www.fda.gov/AdvisoryCommittees/AboutAdvisoryCommittees/ucm111462.htm for procedures
on public conduct during advisory committee meetings.
    Notice of this meeting is given under the Federal Advisory
Committee Act (5 U.S.C. app. 2).

    Dated: June 30, 2011.
Jill Hartzler Warner,
Acting Associate Commissioner for Special Medical Programs.
[FR Doc. 2011-16859 Filed 7-5-11; 8:45 am]
BILLING CODE 4160-01-P