Given the rapid demographic changes experienced in recent years and the strong expectation that such changes will continue and accelerate, the once-a-decade data collection approach of a decennial census is no longer acceptable. To meet the needs and expectations of the country, the Census Bureau developed the American Community Survey. This survey will collect long-form data every month and provide tabulations of these data on a yearly basis. In the past, the long-form data were collected only at the time of each decennial census. The American Community Survey will allow the Census Bureau to remove the long form from the 2010 Census, thus reducing operational risks, improving accuracy, and providing more relevant data. After years of development and testing, the American Community Survey is ready for full implementation in FY 2003.

The American Community Survey will provide more timely information for critical economic planning by governments and the private sector. In the current information-based economy, federal, state, tribal, and local decisionmakers, as well as private business and nongovernmental organizations, need current, reliable, and comparable socioeconomic data to chart the future. The American Community Survey will provide up-to-date profiles of American communities every year beginning in 2004, providing policymakers, planners, and service providers in the public and private sectors with information every year—not just every ten years.

The American Community Survey must begin full implementation in 2003 to provide comparable data at the census tract level by July 2008. These data are needed by federal agencies and others to provide assurance of long-form type data availability before eliminating the long form from the 2010 Census.

The American Community Survey demonstration period began in 1996 in four sites. In 1999, the number of sites was increased to 31 comparison sites. The comparison with Census 2000 was designed to collect several kinds of information necessary to understand the differences between data from the 1999-2002 American Community Survey and data from the 2000 long form. The purpose of the comparison sites was to give a good tract-by-tract comparison between the 1999-2002 American Community Survey cumulated estimates and the Census 2000 long-form estimates and to use these comparisons to identify both the causes of differences and diagnostic variables that tend to predict a certain kind of difference.

In 2000-2002, the Census Bureau conducted the Census 2000 Supplementary Survey, the 2001 Supplementary Survey, and the 2002 Supplementary Survey using the American Community Survey methodology. Each of these surveys had a sample of approximately 700,000 residential addresses per year. These surveys were conducted to study the operational feasibility of collecting long-form type data in a different methodology from the decennial census, demonstrate the reliability and stability of state and large area estimates over time, and demonstrate the usability of multiyear estimates.

For 2003-2005, the Census Bureau plans to conduct the American Community Survey in every part of the United States and also in Puerto Rico. In November 2002, the Census Bureau will begin full implementation of the American Community Survey by increasing the sample to a total of 250,000 residential addresses per month in the 50 states and the District of Columbia and 3,000 residential addresses per month in Puerto Rico. Data will be collected by mail and Census Bureau staff will follow up with households that do not respond using computer-assisted telephone interviewing (CATI) and computer-assisted personal interviewing (CAPI).

In addition to selecting a sample of residential addresses, the Census Bureau plans to select a sample of group quarters (GQs) and conduct the American Community Survey with a sample of persons within the GQs starting in January 2004. The Census Bureau will also conduct a reinterview operation with a small sample of households to monitor the quality of data collected during the CAPI.

The Census Bureau will mail questionnaires to households selected for the American Community Survey. For households that do not return a questionnaire, Census Bureau staff will attempt to conduct interviews via CATI. We will also conduct CAPI interviews for a subsample of nonrespondents.

For most types of GQs, Census Bureau field representatives (FRs) will either help respondents complete questionnaires or leave questionnaires and ask respondents to return them by mail. For a few GQs, the FRs will attempt to conduct interviews by telephone.

The Census Bureau staff will provide Telephone Questionnaire Assistance (TQA).

The Census Bureau staff will conduct reinterviews using CAPI.

OMB Number: 0607-0810.

Form Number(s): ACS-1, ACS-1 (GQ), ACS-3 (GQ), ACS-4(GQ), ACS-290.

Type of Review: Regular.

Affected Public: Individuals and households.

Estimated Number of Respondents: During the period of November 2002 through October 2005, we plan to contact 9,105,000 households, 40,000 persons in group quarters, and 81,000 households for reinterview.

Estimated Time Per Response: Estimates are 38 minutes per household, 15 minutes per person in group quarters, and 10 minutes per household in the reinterview sample.

Estimated Total Annual Burden Hours: 1,930,000 hours.

Estimated Total Annual Cost: Except for their time, there is no cost to respondents.

Respondent Obligation: Mandatory.

Comments are invited on: (a) Whether the proposed collection of information is necessary for the proper performance of the functions of the agency, including whether the information shall have practical utility; (b) the accuracy of the agency's estimate of the burden (including hours and cost) of the proposed collection of information; (c) ways to enhance the quality, utility, and clarity of the information to be collected; and (d) ways to minimize the burden of the collection of information on respondents, including through the use of automated collections techniques or other forms of information technology.

Comments submitted in response to this notice will be summarized and included in the request for the OMB approval of this information collection; they also will become a matter of public record.

The Census Bureau is the preeminent collector and provider of timely, relevant and quality data about the people and economy of the United States. Economic data are the Census Bureau's primary program commitment during nondecennial census years. The economic census, conducted under authority of Title 13, United States Code, is the primary source of facts about the structure and functioning of the Nation's economy and features unique industry and geographic detail. Economic census statistics serve as part of the framework for the national accounts and provide essential information for government, business and the general public. The 2002 Economic Census Covering the Manufacturing Sector will measure the economic activity for more than 400,000 manufacturing establishments.

The information collected from companies in the manufacturing sector of the economic census will produce basic statistics by industry for number of establishments, payroll, employment, value of shipments, value added, capital expenditures, depreciation, materials consumed, selected purchased services, electric energy used and inventories held. Primary strategies for reducing burden in the Census Bureau economic data collections are to increase electronic reporting through broader use of computerized self-administered census questionnaires, electronic data interchange, and other electronic data collection methods.

Establishments included in this collection will be selected from a frame provided by the Census Bureau's Business Register. To be eligible for selection, an establishment will be required to satisfy the following conditions: (i) It must be classified in the manufacturing sector; (ii) it must be an active operating establishment of a multi-establishment company, or it must be an operating single-establishment company with payroll; and (iii) it must be located in one of the 50 states or the District of Columbia. Most establishments will be included in the mail portion of the collection. Forms tailored for the particular kind of business will be mailed to the establishment to be filled out and returned. Establishments not meeting certain cutoffs for payroll will be included in the non-mail portion of the collection. We will use administrative data in lieu of collecting data directly from these establishments.

Mail selection procedures will distinguish several groups of establishments. Establishment selection to a particular group is based on a number of factors. The more important considerations are the size of the company and whether it is included in the intercensal Annual Survey of Manufactures (ASM) sample panel. The ASM panel is representative of both large and small establishments from the mail component of the manufacturing census. The ASM sample panel includes approximately 55,000 establishments. The various groups of establishments that will constitute the 2002 Economic Census are outlined below.

Selection procedures will assign eligible establishments of multi-establishment companies to the mail components of the potential respondent universe.

We estimate that the census mail canvass for 2002 will include the following:

1. ASM sample establishments: 32,000.

2. Non-ASM: 50,000.

As an initial step in the selection process, we will conduct a study of the potential respondent universe for manufacturing. The study of potential respondents will produce a set of industry-specific payroll cutoffs that we will use to distinguish large versus small-establishment companies within each industry. This payroll size distinction will affect selection as follows:

Single-establishment companies having annualized payroll (from Federal administrative records) that equals or exceeds the cutoff for their industry will be assigned to the mail component of the potential respondent universe.

We estimate that the census mail canvass for 2002 will include the following:

a. ASM sample establishments: 23,000.

b. Non-ASM: 101,000.

In selected industries, small single-establishment companies that satisfy a particular criteria (administrative record payroll cutoff) will receive a manufacturing short form, which will collect a reduced amount of basic statistics and other essential information that is not available from administrative records.

We estimate that the census mail canvass for 2002 will include approximately 54,000 companies in this category. This category does not contain ASM establishments.

3. All remaining single-establishment companies with payroll will be represented in the census by data estimated from Federal administrative records. Generally, we do not include these small employers in the census mail canvass.

We estimate that this category for 2002 will include approximately 140,000 manufacturing companies.

OMB Number: Not available.

Form Number: The forms used to collect information from businesses in these sectors of the economic census are tailored to specific business practices and are too numerous to list separately in this notice. You can obtain information on the proposed content of the forms by calling Mendel D. Gayle on (301) 457-4769 (or via the Internet at mendel.d.gayle@census.gov ).

Type of Review: Regular review.

Affected Public: Business or Other for Profit, Non-profit Institutions, Small Businesses or Organizations, and State or Local Governments.

Estimated Number of Respondents:

Estimated Time Per Response:

Estimated Total Annual Burden Hours:

Estimated Total Annual Cost: $14,403,864.

Respondent's Obligation: Mandatory.

Legal Authority: Title 13, United States Code, Sections 131 and 224.

Comments are invited on: (a) Whether the proposed collection of information is necessary for the proper performance of the functions of the agency, including whether the information shall have practical utility; (b) the accuracy of the agency's estimate of the burden (including hours and cost) of the proposed collection of information; (c) ways to enhance the quality, utility, and clarity of the information to be collected; and (d) ways to minimize the burden of the collection of information on respondents, including through the use of automated collection techniques or other forms of information technology.

Comments submitted in response to this notice will be summarized and/or included in the request for OMB approval of this information collection; they also will become a matter of public record.

Unless otherwise indicated, all citations to the Tariff Act of 1930, as amended (the Act), are references to the provisions effective January 1, 1995, the effective date of the amendments made to the Act by the Uruguay Round Agreements Act. In addition, unless otherwise indicated, all citations to the Department of Commerce's (the Department's) regulations are to 19 CFR part 351 (April 2000).

This review covers one manufacturer/exporter, Tokyo Kikai Seisakusho, Ltd. (TKS).

On October 9, 2001, the Department of Commerce published in the Federal Register the preliminary results of administrative review of the antidumping duty order on large newspaper printing presses (LNPP) and components thereof, whether assembled or unassembled, from Japan (66 FR 51379) ( Preliminary Results ).

We invited parties to comment on the preliminary results of the review. TKS submitted a case brief on November 8, 2001. On December 4, 2001, TKS withdrew its case brief from the record of this review. No other interested party submitted comments. The Department has conducted this administrative review in accordance with section 751 of the Act.

The products covered by the order are large newspaper printing presses, including press systems, press additions and press components, whether assembled or unassembled, whether complete or incomplete, that are capable of printing or otherwise manipulating a roll of paper more than two pages across. A page is defined as a newspaper broadsheet page in which the lines of type are printed perpendicular to the running of the direction of the paper or a newspaper tabloid page with lines of type parallel to the running of the direction of the paper.

In addition to press systems, the scope of the order includes the five press system components. They are: (1) A printing unit, which is any component that prints in monocolor, spot color and/or process (full) color; (2) a reel tension paster (RTP), which is any component that feeds a roll of paper more than two newspaper broadsheet pages in width into a subject printing unit; (3) a folder, which is a module or combination of modules capable of cutting, folding, and/or delivering the paper from a roll or rolls of newspaper broadsheet paper more than two pages in width into a newspaper format; (4) conveyance and access apparatus capable of manipulating a roll of paper more than two newspaper broadsheet pages across through the production process and which provides structural support and access; and (5) a computerized control system, which is any computer equipment and/or software designed specifically to control, monitor, adjust, and coordinate the functions and operations of large newspaper printing presses or press components.

A press addition is comprised of a union of one or more of the press components defined above and the equipment necessary to integrate such components into an existing press system.

Because of their size, large newspaper printing press systems, press additions, and press components are typically shipped either partially assembled or unassembled, complete or incomplete, and are assembled and/or completed prior to and/or during the installation process in the United States. Any of the five components, or collection of components, the use of which is to fulfill a contract for large newspaper printing press systems, press additions, or press components, regardless of degree of assembly and/or degree of combination with non-subject elements before or after importation, is included in the scope of this order. Also included in the scope are elements of a LNPP system, addition or component, which taken altogether, constitute at least 50 percent of the cost of manufacture of any of the five major LNPP components of which they are a part.

For purposes of the order, the following definitions apply irrespective of any different definition that may be found in Customs rulings, U.S. Customs law or the Harmonized Tariff Schedule of the United States (HTSUS): (1) The term “unassembled” means fully or partially unassembled or disassembled; and (2) the term “incomplete” means lacking one or more elements with which the LNPP is intended to be equipped in order to fulfill a contract for a LNPP system, addition or component.

This scope does not cover spare or replacement parts. Spare or replacement parts imported pursuant to a LNPP contract, which are not integral to the original start-up and operation of the LNPP, and are separately identified and valued in a LNPP contract, whether or not shipped in combination with covered merchandise, are excluded from the scope of this order. Used presses are also not subject to this scope. Used presses are those that have been previously sold in an arm's-length transaction to a purchaser that used them to produce newspapers in the ordinary course of business.

Also excluded from the scope, in accordance with the Department's determination in a changed- circumstances antidumping duty administrative review of the order which resulted in the partial revocation of the order with respect to certain merchandise, are elements and components of LNPP systems, and additions thereto, which feature a 22 inch cut-off, 50 inch web width and a rated speed no greater than 75,000 copies per hour. See Large Newspaper Printing Presses Components Thereof, Whether Assembled or Unassembled, from Japan: Final Results of Changed Circumstances Antidumping Duty Administrative Review and Intent to Revoke Antidumping Duty Order, In Part, 64 FR 72315 (Dec. 27, 1999). In addition to the specifications set out in this paragraph, all of which must be met in order for the product to be excluded from the scope of the order, the product must also meet all of the specifications detailed in the five numbered sections following this paragraph. If one or more of these criteria is not fulfilled, the product is not excluded from the scope of the order.

1. Printing Unit: A printing unit which is a color keyless blanket-to-blanket tower unit with a fixed gain infeed and fixed gain outfeed, with a rated speed no greater than 75,000 copies per hour, which includes the following features:

• Each tower consisting of four levels, one or more of which must be populated.

• Plate cylinders which contain slot lock-ups and blanket cylinders which contain reel rod lock-ups both of which are of solid carbon steel with nickel plating and with bearers at both ends which are configured in-line with bearers of other cylinders.

• Keyless inking system which consists of a passive feed ink delivery system, an eight roller ink train, and a non-anilox and non-porous metering roller.

• The dampener system which consists of a two nozzle per page spraybar and two roller dampener with one chrome drum and one form roller.

• The equipment contained in the color keyless ink delivery system is designed to achieve a constant, uniform feed of ink film across the cylinder without ink keys. This system requires use of keyless ink which accepts greater water content.

2. Folder: A module which is a double 3:2 rotary folder with 160 pages collect capability and double (over and under) delivery, with a cut-off length of 22 inches. The upper section consists of three-high double formers (total of 6) with six sets of nipping rollers.

3. RTP: A component which is of the two-arm design with core drives and core brakes, designed for 50 inch diameter rolls; and arranged in the press line in the back-to-back configuration (left and right hand load pairs).

4. Conveyance and Access Apparatus: Conveyance and access apparatus capable of manipulating a roll of paper more than two newspaper broadsheets across through the production process, and a drive system which is of conventional shafted design.

5. Computerized Control System: A computerized control system, which is any computer equipment and/or software designed specifically to control, monitor, adjust, and coordinate the functions and operations of large newspaper printing presses or press components.

Further, this order covers all current and future printing technologies capable of printing newspapers, including, but not limited to, lithographic (offset or direct), flexographic, and letterpress systems. The products covered by this order are imported into the United States under subheadings 8443.11.10, 8443.11.50, 8443.30.00, 8443.59.50, 8443.60.00, and 8443.90.50 of the HTSUS. Large newspaper printing presses may also enter under HTSUS subheadings 8443.21.00 and 8443.40.00. Large newspaper printing press computerized control systems may enter under HTSUS subheadings 8471.49.10, 8471.49.21, 8471.49.26, 8471.50.40, 8471.50.80, and 8537.10.90. Although the HTSUS subheadings are provided for convenience and customs purposes, our written description of the scope of the order is dispositive.

On September 29, 2000, the petitioner requested that the Department determine whether antidumping duties had been absorbed during the period of review (POR). Section 751(a)(4) of the Act provides for the Department, if requested, to determine during an administrative review initiated two or four years after the publication of the order, whether antidumping duties have been absorbed by a foreign producer or exporter, if the subject merchandise is sold in the United States through an affiliated importer. In this case, TKS sold to the United States through an importer that is affiliated within the meaning of section 771(33) of the Act.

Because this review was initiated four years after the publication of the antidumping duty order, we will make a duty absorption determination in this segment of the proceeding. As we have found that there is no dumping margin for TKS with respect to its U.S. sales, we have also found that there is no duty absorption for purposes of the final results.

Mitsubishi Heavy Industries, Ltd. (MHI) notified the Department that it had not made any U.S. sales or entries of subject merchandise during the POR. Accordingly, in the preliminary results, we made a preliminary determination to rescind this review with respect to MHI. As we have not received any comments on this determination, we are rescinding this review with respect to MHI.

The Department “may revoke, in whole or in part,” an antidumping duty order upon completion of a review under section 751 of the Act. While Congress has not specified the procedures that the Department must follow in revoking an order, the Department has developed a procedure for revocation that is described in 19 CFR 351.222. This regulation requires, inter alia , that a company requesting revocation must submit the following: (1) A certification that the company has sold the subject merchandise at not less than normal value (NV) in the current review period and that the company will not sell at less than NV in the future; (2) a certification that the company sold the subject merchandise in each of the three years forming the basis of the request in commercial quantities; and (3) an agreement to reinstatement of the order if the Department concludes that the company, subsequent to the revocation, sold subject merchandise at less than NV. See 19 CFR 351.222(e)(1). Upon receipt of such a request, the Department will revoke an order, in part, if it concludes that: (1) The company in question has sold subject merchandise at not less than NV for a period of at least three consecutive years; (2) the continued application of the antidumping order is not otherwise necessary to offset dumping; and (3) the company has agreed in writing to immediate reinstatement of the order if the Department concludes that the company, subsequent to the revocation, sold subject merchandise at less than NV. See 19 CFR part 351.222(b)(2).

In the preliminary results, we found that TKS met the requirements for revocation ( see Preliminary Results ). We received no comments on this determination. Accordingly, we have determined that the Department's requirements for revocation have been met. Based on the final results in this review and the final results of the two preceding reviews, TKS has demonstrated three consecutive years of sales at not less than NV. Furthermore, we find that TKS's aggregate sales to the United States have been made in commercial quantities during each of those years. In the particular situation of LNPPs, one sale, which may be worth millions of dollars, constitutes a commercial quantity. TKS had at least one sale in each of the three reviews. Finally, based on our review of the record, there is no basis to find continued application of the order is necessary to offset dumping.

Therefore, for the reasons discussed above, we find that TKS qualifies for revocation of the order on LNPPs which it produces and exports to the United States under 19 CFR 351.222(b)(2)(ii).

Our final results remain unchanged from the preliminary results. The following weighted-average margin percentage applies to TKS for the period September 1, 1999, through August 31, 2000:

This revocation applies to all entries of subject merchandise that are produced by TKS and that are also exported by TKS, entered, or withdrawn from warehouse, for consumption on or after September 1, 2000. The Department will order the suspension of liquidation ended for all such entries and will instruct the Customs Service to release any cash deposits or bonds. The Department will further instruct the Customs Service to refund with interest any cash deposits on entries made after August 31, 2000.

The Department shall determine, and the Customs Service shall assess, antidumping duties on all appropriate entries. The Department will issue appraisement instructions directly to the Customs Service. In accordance with 19 CFR part 351.106(c)(2), we will instruct the Customs Service to liquidate without regard to antidumping duties all entries of the subject merchandise for which the importer-specific assessment rate is zero or de minimis ( i.e ., less than 0.50 percent).

This notice serves as a final reminder to importers of their responsibility under 19 CFR 351.402(f)(2) to file a certificate regarding the reimbursement of antidumping duties prior to liquidation of the relevant entries during this review period. Failure to comply with this requirement could result in the Secretary's presumption that reimbursement of antidumping duties occurred and the subsequent assessment of double antidumping duties.

The following deposit requirements shall be effective for all shipments of the subject merchandise from Japan that are entered, or withdrawn from warehouse, for consumption on or after the publication date of the final results of this administrative review, as provided for by section 751(a)(1) of the Act: (1) Cash deposits for TKS will no longer be required and the suspension of liquidation will cease for entries made on or after September 1, 2000; (2) for previously investigated companies not listed above, the cash deposit rate will continue to be the company-specific rate published for the most recent period; (3) if the exporter is not a firm covered in this review, or the original investigation, but the manufacturer is, the cash deposit rate will be the rate established for the most recent period for the manufacturer of the merchandise; and (4) the cash deposit rate for all other manufacturers or exporters of this merchandise will continue to be 58.69 percent, the all others rate made effective by the less-than-fair-value investigation. These requirements, when imposed, shall remain in effect until publication of the final results of the next administrative review.

This notice serves as the only reminder to parties subject to administrative protective order (APO) of their responsibility concerning the disposition of proprietary information disclosed under APO in accordance with 19 CFR part 351.305(a)(3). Timely written notification of return/destruction of APO materials or conversion to judicial protective order is hereby requested. Failure to comply with the regulation and the terms of an APO is a sanctionable violation.

This administrative review and notice are issued and published in accordance with sections 751(a)(1) and 777(i)(1) of the Act and 19 CFR part 351.221.

Unless otherwise indicated, all citations to the Tariff Act of 1930, as amended (the Act), are references to the provisions effective January 1, 1995, the effective date of the amendments made to the Act by the Uruguay Round Agreements Act (URAA). In addition, unless otherwise indicated, all citations to the Department of Commerce's (the Department's) regulations are to 19 CFR part 351 (April 2000).

This review covers one manufacturer/exporter, MAN Roland Druckmaschinen AG (MAN Roland).

On October 9, 2001, the Department of Commerce published in the Federal Register the preliminary results of administrative review of the antidumping duty order on large newspaper printing presses (LNPP) and components thereof, whether assembled or unassembled, from Germany (66 FR 51375) ( Preliminary Results ).

We invited parties to comment on the preliminary results of the review. MAN Roland submitted a case brief on November 8, 2001. On November 29, 2001, MAN Roland withdrew its case brief from the record of this review. No other interested party submitted comments. The Department has conducted this administrative review in accordance with section 751 of the Act.

The products covered by the order are large newspaper printing presses, including press systems, press additions and press components, whether assembled or unassembled, whether complete or incomplete, that are capable of printing or otherwise manipulating a roll of paper more than two pages across. A page is defined as a newspaper broadsheet page in which the lines of type are printed perpendicular to the running of the direction of the paper or a newspaper tabloid page with lines of type parallel to the running of the direction of the paper.

In addition to press systems, the scope of the order includes the five press system components. They are: (1) A printing unit, which is any component that prints in monocolor, spot color and/or process (full) color; (2) a reel tension paster (RTP), which is any component that feeds a roll of paper more than two newspaper broadsheet pages in width into a subject printing unit; (3) a folder, which is a module or combination of modules capable of cutting, folding, and/or delivering the paper from a roll or rolls of newspaper broadsheet paper more than two pages in width into a newspaper format; (4) conveyance and access apparatus capable of manipulating a roll of paper more than two newspaper broadsheet pages across through the production process and which provides structural support and access; and (5) a computerized control system, which is any computer equipment and/or software designed specifically to control, monitor, adjust, and coordinate the functions and operations of large newspaper printing presses or press components.

A press addition is comprised of a union of one or more of the press components defined above and the equipment necessary to integrate such components into an existing press system.

Because of their size, large newspaper printing press systems, press additions, and press components are typically shipped either partially assembled or unassembled, complete or incomplete, and are assembled and/or completed prior to and/or during the installation process in the United States. Any of the five components, or collection of components, the use of which is to fulfill a contract for large newspaper printing press systems, press additions, or press components, regardless of degree of assembly and/or degree of combination with non-subject elements before or after importation, is included in the scope of this order. Also included in the scope are elements of a LNPP system, addition or component, which taken altogether, constitute at least 50 percent of the cost of manufacture of any of the five major LNPP components of which they are a part.

For purposes of the order, the following definitions apply irrespective of any different definition that may be found in Customs rulings, U.S. Customs law or the Harmonized Tariff Schedule of the United States (HTSUS): (1) The term “unassembled” means fully or partially unassembled or disassembled; and (2) the term “incomplete” means lacking one or more elements with which the LNPP is intended to be equipped in order to fulfill a contract for a LNPP system, addition or component.

This scope does not cover spare or replacement parts. Spare or replacement parts imported pursuant to a LNPP contract, which are not integral to the original start-up and operation of the LNPP, and are separately identified and valued in a LNPP contract, whether or not shipped in combination with covered merchandise, are excluded from the scope of this order. Used presses are also not subject to this scope. Used presses are those that have been previously sold in an arm's-length transaction to a purchaser that used them to produce newspapers in the ordinary course of business.

Further, this order covers all current and future printing technologies capable of printing newspapers, including, but not limited to, lithographic (offset or direct), flexographic, and letterpress systems. The products covered by this order are imported into the United States under subheadings 8443.11.10, 8443.11.50, 8443.30.00, 8443.59.50, 8443.60.00, and 8443.90.50 of the HTSUS. Large newspaper printing presses may also enter under HTSUS subheadings 8443.21.00 and 8443.40.00. Large newspaper printing press computerized control systems may enter under HTSUS subheadings 8471.49.10, 8471.49.21, 8471.49.26, 8471.50.40, 8471.50.80, and 8537.10.90. Although the HTSUS subheadings are provided for convenience and customs purposes, our written description of the scope of the order is dispositive.

On September 29, 2000, the petitioner requested that the Department determine whether antidumping duties had been absorbed during the period of review. Section 751(a)(4) of the Act provides for the Department, if requested, to determine during an administrative review initiated two or four years after the publication of the order, whether antidumping duties have been absorbed by a foreign producer or exporter, if the subject merchandise is sold in the United States through an affiliated importer. In this case, MAN Roland sold to the United States through an importer that is affiliated within the meaning of section 771(33) of the Act.

Because this review was initiated four years after the publication of the antidumping duty order, we will make a duty absorption determination in this segment of the proceeding. As we have found that there is no dumping margin for MAN Roland with respect to its U.S. sales, we have also found that there is no duty absorption for purposes of the final results.

Our final results remain unchanged from the preliminary results. The following weighted-average margin percentage applies to MAN Roland for the period September 1, 1999, through August 31, 2000:

Economic performance data for selected West Coast (California-Alaska) commercial fisheries will be collected for each of the following groups of operations: (1) processors, including on-shore plants, mothership vessels and at-sea catcher/processor vessels; (2) catcher vessels; and (3) charter vessels. Companies associated with these groups will be surveyed for expenditure, earnings and employment data. In general, questions will be asked concerning ex-vessel and wholesale prices and revenue, variable and fixed costs, expenditures, dependence on the fisheries, and fishery employment. The data collection efforts will be coordinated to reduce the additional burden for those who participate in multiple fisheries. Each year the principal focus of this data collection program will be on a different set of fisheries or on a different set of participants in these fisheries. The data will be used for the following three purposes: (1) to monitor the economic performance of these fisheries and various components of these fisheries through primary processing; (2) to analyze the economic performance effects of current management measures; and (3) to analyze the economic performance effects of alternative management measures. The measures of economic performance to be supported by this data collection program include the following: (1) contribution to net National benefit; (2) contribution to income of groups of participants in the fisheries (i.e., fishermen, vessel owners, processing plant employees, and processing plant owners) (3) employment; (4) regional economic impacts (income and employment); and (5) factor utilization rates. As required by law, the confidentiality of the data will be protected.

In each year, the data collection effort will focus on different components of the West Coast fisheries and more limited data will be collected for the previously surveyed components of these fisheries. The latter will be done to update the models that will be used to track economic performance and to evaluate the economic effects of alternative management actions. This cycle of data collection will result in economic performance data being available and updated for all the components of the West Coast fisheries identified above.

The large scale of most of the processing operations involved in these fisheries and of many of the harvesting operations and the concentration of ownership in many of these fisheries, particularly off Alaska, means that improved economic data for the management of these fisheries is a high priority for the individuals who will provide data for these fisheries. This is demonstrated by the fact that associations representing many of the Alaskan participants in these fisheries support this data collection effort and have volunteered to assist in verifying the data.

Data will be collected from a sample of the owners and operators of catcher vessels, catcher/processors, on-shore processing plants, motherships and charter vessels that participate in these fisheries. The data are expected to be collected principally by NMFS and Pacific States Marine Fisheries Commission economists. Questionnaires will be mailed to the selected members of each of the different survey groups and in many cases those individuals will be interviewed to ensure the clarity of their responses. To the extent practicable, the data collected will consist of data that the respondents maintain for their own business purposes. Therefore, the collection burden will consist principally of transcribing data from their internal records to the survey instrument and participating in personal interviews. In addition, current data reporting requirements will be evaluated to determine if they can be modified to provide improved economic data at a lower cost to respondents and the Agency. Similarly, it will be determined if some of these data can be collected more effectively and efficiently from the firms that provide bookkeeping and accounting services to participants in West Cost commercial marine fisheries. This data collection method would be used only after obtaining permission to do so from participants in the fisheries.

The surveys described in this Federal Register Notice will be voluntary. The North Pacific Fishery Management Council is considering the development of additional mandatory reporting requirements for economic data. If such requirements are implemented, the data collected with voluntary surveys in Alaska would be decreased.

OMB Number : 0648-0369.

Form Number : None.

Type of Review : Regular submission.

Affected Public : Business and other for-profit organizations.

Estimated Number of Respondents : 2,278.

Estimated Time Per Response : 2 hours for a response from a catcher vessel; 1 hour for a response from a charter boat operator; and 8 hours for a response from a processor.

Estimated Total Annual Burden Hours : 7,074.

Estimated Total Annual Cost to Public : $0.

Comments are invited on: (a) whether the proposed collection of information is necessary for the proper performance of the functions of the agency, including whether the information shall have practical utility; (b) the accuracy of the agency’s estimate of the burden (including hours and cost) of the proposed collection of information; (c) ways to enhance the quality, utility, and clarity of the information to be collected; and (d) ways to minimize the burden of the collection of information on respondents, including through the use of automated collection techniques or other forms of information technology.

Comments submitted in response to this notice will be summarized and/or included in the request for OMB approval of this information collection; they also will become a matter of public record.

The meeting will begin at 10:30 a.m. on Tuesday, January 29, continue through Wednesday, January 30. The committee's agenda includes the following issues:

1. Review of alternatives for EFH and habitat areas of particular concern (HAPC).

2. Discussion of HAPC site designation/proposal process.

3. Develop final recommendation on EFH and HAPC alternatives.

4. Review draft Groundfish Programmatic Groundfish Supplementary Environmental Impact Statement schedule, table of contents, and purpose and need statements.

5. Presentation and discussion of white paper on mitigation alternatives and gear impact analysis.

6. Discussion of format for NMFS workshop on gear effects.

Although non-emergency issues not contained in this agenda may come before this group for discussion, those issues may not be the subject of formal action during this meeting. Action will be restricted to those issues specifically identified in this notice and any issues arising after publication of this notice that require emergency action under section 305(c) of the Magnuson-Stevens Fishery Conservation and Management Act, provided the public has been notified of the Council's intent to take final action to address the emergency.

These meetings are physically accessible to people with disabilities. Requests for sign language interpretation or other auxiliary aids should be directed to Helen Allen, 907-271-2809, at least 5 working days prior to the meeting date.

The subject amendment to Permit No. 775-1600-01, issued on March 6, 2001 (66 FR 32793) is requested under the authority of the Marine Mammal Protection Act of 1972, as amended (16 U.S.C. 1361 et seq .), and the Regulations Governing the Taking and Importing of Marine Mammals (50 CFR part 216).

Permit No. 775-1600-01 authorizes the permit holder to conduct research on 28 species of cetacean in the North Atlantic Ocean, and on harbor seals ( Phoca vitulina ), gray seals ( Halichoerus grypus ), harp seals ( Phoca groenlandica ), and hooded seals ( Cystophora cristata ) in coastal Maine, Massachusetts, New Hampshire, and Delaware. The principal purpose of the research, for all species, relates to stock assessment, an activity for which NMFS has primary responsibility under the MMPA. Types of take for cetaceans include potential harassment by shipboard and aerial approach, photo-ID, biopsy sampling, acoustic sampling, and tagging. Types of take for the 4 species of pinnipeds include potential harassment by shipboard and aerial approach; type of takes for harbor and gray seals include photo-ID and incidental harassment during scat and carcass collections; harbor seals may also be captured, biopsy and blood sampled, VHF tagged, “hat tagged”, and flipper tagged. The Permit also authorizes import and export of marine mammal parts (including soft and hard tissue, blood, extracted DNA, and whole dead animals or parts thereof) to and from any country.

The permit holder requests authorization to capture, examine, measure, flipper tag (retain tissue from tagging), apply a “seal hat”, and photograph up to 200 gray seal pups; blood sample 50 of the 200 pups captured; and VHF tag 30 of the 200 pups captured. These activities would occur in coastal Maine and Massachusetts for purposes of stock assessment.

In compliance with the National Environmental Policy Act of 1969 (42 U.S.C. 4321 et seq .), an initial determination has been made that the activity proposed is categorically excluded from the requirement to prepare an environmental assessment or environmental impact statement.

Project Location: This notice announces the initiation of the feasibility phase study for beach erosion control, storm damage reduction and related purposes along the north shore of Long Island at Asharoken, NY. The study area extends from Long Island Sound on the north, Duck Island Harbor and Northport Bay on the south, the North Power Station on the East and Eatons Neck on the west.

Project Authorization and History: The North Shore of Long Island, village of Asharoken, New York, Hurricane and Storm Damage Reduction Study was authorized by a resolution of the U.S. House of Representatives Committee on Public Works and Transportation, adopted May 13, 1993. In response to the study resolution and a State request, following the devastating coastal storm of December 1992, the USACE performed a Reconnaissance Study and issued a Reconnaissance Report in September 1995 that demonstrated a potential Federal interest and the need for a more detailed feasibility study.

Project Need; The Long Island northern shoreline has historically experienced coastal erosion and related storm damage, most recently from the two storms of September 1996 and October 1996, and from previous storms including the Christmas Eve 1994 storm, and March 1993 Blizzard of the Century, the December 1992 northeaster, Hurricane Danielle of September 1992 and Halloween Storm of 1991. These Storms caused evacuations in several north shore communities as well as damage from flooding and loss of structures from erosion. The December 1992 storm alone inundated hundreds of residential and business properties and caused damages estimated at $12,000,000. The loss of beachfront in some areas now leaves the site increasingly vulnerable to severe damages even from moderate storms. The length of Asharoken Beach is approximately 2.5 miles, while the width varies from 100 feet at the northwestern end to 1,000 feet at the southeastern end. Asharoken Avenue, which generally runs parallel to the Long Island Sound shoreline, provides only vehicular access to the Village and the Eatons Neck community. While the most critically threatened location of Asharoken Avenue is protected by a small temporary shore protection project, the feasibility study will consider long-term protection throughout the Village.

DEIS Scope: The intended DEIS will evaluate the potential environmental and cultural impacts associated with the proposed hurricane and storm damage reduction alternatives for the Village of Asharoken, NY.

Public Involvement: The USACE intends to schedule an interagency meeting and public scoping meeting in the spring/summer 2002 to discuss the scope of the DEIS and data gaps. The public scoping meeting place, date, and time will be advertised in advance in local newspapers, and meeting announcement letters will be sent to interested parties. A scoping document will be made available at least one month before scheduled public scoping meeting date at the following locations:

(1) Northport Public Library, 151 Laurel Avenue, Northport, NY 11768.

(2) East Northport Public Library, 185 Larkfield Road, East Northport, NY 11731.

(3) Huntington Main Library, 338 Main Street, Huntington, NY 11743.

The public will have an opportunity to provide written and oral comments at the public scoping meeting. Written comments may also be submitted via mail and should be directed to Ms. Megan B. Grubb at the address listed above under FOR FURTHER INFORMATION CONTACT heading. The USACE plans to issue the DEIS in Spring 2003. The USACE will announce availability of the draft in the Federal Register and other media, and will provide the public, organizations, and agencies with the opportunity to submit comments, which will be addressed in the final Environmental Impact Statement.

Project Location: This notice announces of the feasibility phase study for beach erosion control, storm damage reduction and related purposes along the north shore of Long Island at Bayville, NY. The study area extends from Long Island Sound on the north, Mill Neck Creek and Oyster Bay on the South, Centre Island on the east and the western boundary of the Village of Bayville on the west.

Project Authorization and History: The North Shore of Long Island, Village of Bayville, New York, Hurricane and Storm Damage Reduction Study was authorized by a resolution of the U.S. House of Representatives Committee on Public Works and Transportation, adopted May 13, 1993. In response to the study resolution and a State request following the devastating coastal storm of December 1992, the USACE performed a Reconnaissance Study and issued a Reconnaissance Report in September 1995 that demonstrated potential Federal interest and the need for a more detailed feasibility study.

Project Need: The Long Island northern shoreline has historically experienced coastal erosion and related storm damage, most recently from the two storms of September 1996 and October 1996, and also from previous storms including the Christmas Eve 1994 storm, the March 1993 Blizzard of the Century, the December 1992 northeaster, Hurricane Danielle of September 1992 and the Halloween Storm of 1991. These storms caused evacuations in several north shore communities as well as damage from flooding and loss of structures from erosion. The December 1992 storm alone inundated hundreds of residential and business properties and caused damages estimated at $12,000,000. Approximately 300 families were evacuated and several sections of Bayville Avenue were impassable for days. The loss of beachfront in some areas now leaves the site increasingly vulnerable to severe damages even from moderate storms.

DEIS Scope: The intended DEIS will evaluate the potential environmental and cultural impacts associated with the purposed hurricane and storm damage reduction alternatives for the Village of Bayville, NY.

Public Involvement: The USACE intends to schedule an interagency meeting and public scoping meeting in spring/summer 2002 to discuss the scope of the DEIS and data gaps. The public scoping meeting place, date, and time will be advertised in advanced in local newspapers, and meeting announcement letters will be sent to interested parties. A scoping document will be made available at least one month before scheduled public scoping meeting date at the following locations:

(1) Bayville Free Library, 34 School Street, Nayville, NY 11709.

(2) Oyster Bay-East Norwich Public Library, 89 E. Main St., Oyster Bay, NY 11771.

The public will have an opportunity to provide written and oral comments at the public scoping meeting. Written comments may also be submitted via mail and should be directed to Ms. Megan B. Grubb at the address listed above under FOR FURTHER INFORMATION CONTACT heading. The USACE plans to issue the DEIS in Spring 2003. The USACE will announce availability of the draft in the Federal Register and other media, and will provide the public, organization, and agencies with the opportunity to submit comments, which will be addressed in the Final Environmental Impact Statement.

1. Scoping Process: The Corps will conduct a scoping meeting prior to preparing the Environmental Impact Statement to aid in determining the significant environmental issues associated with the proposed action. The public, as well as Federal, State, and local agencies are encouraged to participate in the scoping process by submitting data, information, and comments identifying relevant environmental and socioeconomic issues to be addressed in the environmental analysis. Useful information includes other environmental studies, published and unpublished data, alternatives that should be addressed in the analysis, and potential mitigation measures associated with the proposed action.

A public scoping meeting will be held in conjunction with the local sponsor to discuss the project scope and invite public participation in developing alternatives for the project. Individuals and agencies may offer information or data relevant to the environmental or socioeconomic impacts by attending the public scoping meeting, or by mailing the information to the above address.

2. Public Scoping Meeting: A public scoping meeting will be held on January 24, 2002 at 6:00 PM.

Location: Salt River Pima Maricopa Indian Community, Multi-purpose Building, 1880 N Longmore, Scottsdale, AZ 85256.

Section 3506 of the Paperwork Reduction Act of 1995 (44 U.S.C. Chapter 35) requires that the Office of Management and Budget (OMB) provide interested Federal agencies and the public an early opportunity to comment on information collection requests. OMB may amend or waive the requirement for public consultation to the extent that public participation in the approval process would defeat the purpose of the information collection, violate State or Federal law, or substantially interfere with any agency's ability to perform its statutory obligations. The Leader, Regulatory Information Management Group, Office of the Chief Information Officer, publishes that notice containing proposed information collection requests prior to submission of these requests to OMB. Each proposed information collection, grouped by office, contains the following: (1) Type of review requested, e.g. new, revision, extension, existing or reinstatement; (2) Title; (3) Summary of the collection; (4) Description of the need for, and proposed use of, the information; (5) Respondents and frequency of collection; and (6) Reporting and/or Recordkeeping burden. OMB invites public comment.

Type of Review: Revision.

Title: Safe and Drug-Free Schools and Communities Act of the Governor's Report Forms.

Frequency: Annually.

Affected Public: State, Local, or Tribal Gov't, SEAs or LEAs.

Reporting and Recordkeeping Hour Burden: Responses: 56.

Burden Hours: 2,240.

Abstract: Section 4117 of the Safe and Drug-Free Schools and Communities Act (SDFSCA) requires state chief executive officers to submit to the Secretary on a triennial basis a report on the implementation and outcomes of Governor's SDFSCA programs. ED must report to the President and Congress regarding the national impact of SDFSCA programs.

Requests for copies of the proposed information collection request may be accessed from http://edicsweb.ed.gov, or should be addressed to Vivian Reese, Department of Education, 400 Maryland Avenue, SW., Room 4050, Regional Office Building 3, Washington, DC 20202-4651 or to the e-mail address vivian.reese@ed.gov. Requests may also be electronically mailed to the internet address OCIO_RIMG@ed.gov or faxed to 202-708-9346. Please specify the complete title of the information collection when making your request.

Comments regarding burden and/or the collection activity requirements should be directed to Kathy Axt at her internet address Kathy.Axt@ed.gov. Individuals who use a telecommunications device for the deaf (TDD) may call the Federal Information Relay Service (FIRS) at 1-800-877-8339.

We allocate funds to eligible higher education institutions in each of the campus-based programs. We will not allocate funds under the campus-based programs for award year 2002-2003 to any currently non-participating institution unless the institution files its Application for Approval to Participate in Federal Student Financial Aid Programs and required supporting documents by the closing date. If the institution submits its Application for Approval to Participate in Federal Student Financial Aid Programs or other required supporting documents after the February 15, 2002 closing date, we will use this application in determining the institution's eligibility to participate in the campus-based programs beginning with the 2003-2004 award year.

For purposes of this notice, ineligible institutions include only:

(1) An institution that has not been designated as an eligible institution by the Department, but has previously filed a FISAP; or

(2) An additional location of an eligible institution that is currently not included in the Department's eligibility certification for that eligible institution, but has been included in the institution's 2002-2003 FISAP.

The following regulations apply to the campus-based programs:

(1) Student Assistance General Provisions, 34 CFR part 668.

(2) General Provisions for the Federal Perkins Loan Program, Federal Work-Study Program, and Federal Supplemental Educational Opportunity Grant Program, 34 CFR part 673.

(3) Federal Perkins Loan Program, 34 CFR part 674.

(4) Federal Work-Study Program, 34 CFR part 675.

(5) Federal Supplemental Opportunity Grant Program, 34 CFR part 676.

(6) Institutional Eligibility Under the Higher Education Act of 1965, as amended, 34 CFR part 600.

(7) New Restrictions on Lobbying, 34 CFR part 82.

(8) Governmentwide Debarment and Suspension (Nonprocurement) and Governmentwide Requirements for Drug-Free Workplace (Grants), 34 CFR part 85.

(9) Drug-Free Schools and Campuses, 34 CFR part 86.

This action is directed to the public in general, nevertheless, a wide range of stakeholders will be interested in obtaining the interim risk management decision documents for terbufos, including environmental, human health, and agricultural advocates; the chemical industry; pesticide users; and members of the public interested in the use of pesticides on food. Since other entities also may be interested, the Agency has not attempted to describe all the specific entities that may be affected by this action. If you have any questions regarding the applicability of this action to a particular entity, consult the person listed under FOR FURTHER INFORMATION CONTACT .

1. Electronically . You may obtain electronic copies of this document, and certain other related documents that might be available electronically, from the EPA Internet Home Page at http://www.epa.gov/. On the Home Page select “Laws and Regulations,” “Regulations and Proposed Rules,” and then look up the entry for this document under the “ Federal Register —Environmental Documents.” You can also go directly to the Federal Register listings at http://www.epa.gov/fedrgstr/. In addition, copies of the pesticide interim risk management decision documents released to the public may also be accessed at http://www.epa.gov/pesticides/reregistration/status.htm.

2. In person . The Agency has established an official record for this action under docket control number OPP-341399D. The official record consists of the documents specifically referenced in this action, and other information related to this action, including any information claimed as Confidential Business Information (CBI). This official record includes the documents that are physically located in the docket, as well as the documents that are referenced in those documents. The public version of the official record does not include any information claimed as CBI. The public version of the official record, which includes printed, paper versions of any electronic comments submitted during an applicable comment period is available for inspection in the Public Information and Records Integrity Branch (PIRIB), Rm. 119, Crystal Mall #2, 1921 Jefferson Davis Hwy., Arlington, VA, from 8:30 a.m. to 4 p.m., Monday through Friday, excluding legal holidays. The PIRIB telephone number is (703) 305-5805.

EPA has assessed the risks of terbufos and reached an Interim Reregistration Eligibility Decision (IRED) for this organophosphate pesticide. Provided that risk mitigation measures are adopted, terbufos fits into its own risk cup its individual, aggregate risks are within acceptable levels. Used on corn, sorghum, and sugar beets, terbufos residues in food and drinking water do not pose risk concerns with the implementation of certain risk mitigation measures. Terbufos has no residential uses. With other risk reduction measures, worker and ecological risks also will be substantially reduced.

The interim risk management decision documents for terbufos were made through the organophosphate pesticide pilot public participation process, which increases transparency and maximizes stakeholder involvement in EPA's development of risk assessments and risk management decisions. The pilot public participation process was developed as part of the EPA-USDA Tolerance Reassessment Advisory Committee (TRAC), which was established in April 1998, as a subcommittee under the auspices of EPA's National Advisory Council for Environmental Policy and Technology. A goal of the pilot public participation process is to find a more effective way for the public to participate at critical junctures in the Agency's development of organophosphate pesticide risk assessments and risk management decisions. EPA and USDA began implementing this pilot process in August 1998, to increase transparency and opportunities for stakeholder consultation.

EPA worked extensively with affected parties to reach the decisions presented in the interim risk management decision documents, which conclude the pilot public participation process for terbufos. As part of the pilot public participation process, numerous opportunities for public comment were offered as these interim risk management decision documents were being developed. There will also be a 60-day comment period on the interim reregistration eligibility decision and the docket will remain open after this period for any comments submitted to the Agency.

The risk assessments for terbufos were released to the public through a notice published in the Federal Register of August 12, 1998 (63 FR 43175) (FRL-6024-5), and September 1, 1999 (64 FR 34195) (FRL-6099-9).

EPA's next step under FQPA is to complete a cumulative risk assessment and risk management decision for the organophosphate pesticides, which share a common mechanism of toxicity. The interim risk management decision documents on terbufos cannot be considered final until this cumulative assessment is complete. When the cumulative risk assessment for the organophosphate pesticides has been completed, EPA will issue its final tolerance reassessment decision(s) for terbufos and further risk mitigation measures may be needed.

You may be potentially affected by this action if you manufacture or formulate pesticides. Potentially affected categories and entities may include, but are not limited to:

This listing is not intended to be exhaustive, but rather provides a guide for readers regarding entities likely to be affected by this action. Other types of entities not listed could also be affected. The North American Industrial Classification System (NAICS) codes have been provided to assist you and others in determining whether or not this notice affects certain entities. If you have any questions regarding the applicability of this action to a particular entity, consult the person listed under FOR FURTHER INFORMATION CONTACT .

1. Electronically . You may obtain electronic copies of this document, the science policy documents, and certain other related documents that might be available from the Office of Pesticide Programs' Home Page at http://www.epa.gov/pesticides. On the Office of Pesticide Programs' Home Page select “FQPA” and then look up the entry for this document under “Science Policies.” You can also go directly to the listings at the EPA Home page at http://www.epa.gov. On the Home Page select “Laws and Regulations,” “Regulations and Proposed Rules,” and then look up the entry to this document under “ Federal Register —Environmental Documents.” You can go directly to the Federal Register listings at http://www.epa.gov/fedrgstr.

2. In person . The Agency has established an official record for this action under docket control number OPP-00658B. In addition, the documents referenced in the framework notice, which published in the Federal Register on October 29, 1998 (63 FR 58038) (FRL-6041-5) under docket control number OPP-00557, are considered as part of the official record for this action under docket control number OPP-00658B even though not placed in the official record. The official record consists of the documents specifically referenced in this action, and other information related to this action, including any information claimed as Confidential Business Information (CBI). This official record includes the documents that are physically located in the docket, as well as the documents that are referenced in those documents. The public version of the official record does not include any information claimed as CBI. The public version of the official record, which includes printed, paper versions of any electronic comments submitted during an applicable comment period is available for inspection in the Public Information and Records Integrity Branch (PIRIB), Rm. 119, Crystal Mall #2, 1921 Jefferson Davis Hwy., Arlington, VA, from 8:30 a.m. to 4 p.m., Monday through Friday, excluding legal holidays. The PIRIB telephone number is (703) 305-5805.

On August 3, 1996, FQPA was signed into law. The FQPA significantly amended the Federal Insecticide, Fungicide, and Rodenticide Act (FIFRA) and FFDCA. Among other changes, FQPA established a stringent health-based standard (“a reasonable certainty of no harm”) for pesticide residues in foods to assure protection from unacceptable pesticide exposure and strengthened health protections for infants and children from pesticide risks.

Thereafter, the Agency established the Food Safety Advisory Committee (FSAC) as a subcommittee of the National Advisory Council for Environmental Policy and Technology (NACEPT) to assist in soliciting input from stakeholders and to provide input to EPA on the broad policy choices facing the Agency and on strategic direction for the Office of Pesticide Programs (OPP). The Agency has used the interim approaches developed through discussions with FSAC to make regulatory decisions that meet the new FFDCA standard, but that could be revisited if additional information became available or as the science evolved. In addition, the Agency seeks independent review and public participation, generally through presentation of the science policy issues to the FIFRA Scientific Advisory Panel (SAP), a group of independent, outside experts who provide peer review and scientific advice to OPP.

During 1998 and 1999, EPA and the U.S. Department of Agriculture (USDA) established a second subcommittee of NACEPT, the Tolerance Reassessment Advisory Committee (TRAC) to address FFDCA issues and implementation. TRAC comprised more than 50 representatives of affected user, producer, consumer, public health, environmental, states, and other interested groups. The TRAC met from May 27, 1998, through April 29, 1999.

In order to continue the constructive discussions about FFDCA, EPA and USDA have established, under the auspices of NACEPT, the Committee to Advise on Reassessment and Transition (CARAT). The CARAT provides a forum for a broad spectrum of stakeholders to consult with and advise the Agency and the Secretary of Agriculture on pest and pesticide management transition issues related to the tolerance reassessment process. The CARAT is intended to further the valuable work initiated by the FSAC and TRAC toward the use of sound science and greater transparency in regulatory decisionmaking, increased stakeholder participation, and reasonable transition strategies that reduce risks without jeopardizing American agriculture and farm communities.

As a result of the 1998 and 1999 TRAC process, EPA decided that the implementation process and related policies would benefit from providing notice and comment on major science policy issues. The TRAC identified nine science policy areas it believed were key to implementation of tolerance reassessment. EPA agreed to provide one or more documents for comment on each of the nine issues by announcing their availability in the Federal Register . In a notice published in the Federal Register of October 29, 1998 (63 FR 58038) (FRL-6041-5), EPA described its intended approach. Since then, EPA has been issuing a series of draft documents concerning the nine science policy issues. This notice announces the availability of the revised science policy document concerning cumulative risk assessment.

In assessing the potential health risks associated with exposure to pesticides, attention has historically focused on single pathways of exposure (e.g., from pesticide residues in food, water, or residential/nonoccupational uses) for individual chemicals, and not on the potential for individuals to be exposed to multiple pesticides by all pathways concurrently. In 1996, FQPA modified FFDCA to require OPP to consider potential human health risks from all pathways of dietary and nondietary exposures to more than one pesticide acting through a common mechanism of toxicity. This document provides guidance to OPP scientists for evaluating and estimating the potential human risks associated with such multichemical and multipathway exposures to pesticides. This process is referred to as cumulative risk assessment.

The current guidance has been revised in light of review and comment offered by the public on an earlier draft version during the public comment period of June through September 2000 (USEPA, 2000a) (65 FR 40644, June 30, 2000 (FRL-6556-4) and 65 FR 50526, August 18, 2000 (FRL-6739-3)), by the SAP in September and December 1999, and by comments offered by other external parties at the SAP meetings. Furthermore, OPP has gained experience in applying the principles of the draft guidance itself with actual datasets on pesticides that share a common mechanism of toxicity. A pilot analysis was presented to the SAP on 24 organophosphorus pesticides illustrating the hazard and dose-response guidance in September 2000, and on the exposure assessment and risk characterization process in December 2000. The SAP comments on this pilot analysis have also led to refinements in the process of conducting cumulative risk assessments.

Cumulative risk assessments will play a significant role in the evaluation of risks posed by pesticides, and will enable OPP to make regulatory decisions that more fully protect public health and sensitive subpopulations, including infants and children. The cumulative assessment of risks posed by exposure to multiple chemicals by multiple pathways (including food, drinking water, and residential/nonoccupational exposure to air, soil, grass, and indoor surfaces) presents a formidable challenge for OPP. This guidance takes into account the knowledge and methods available now for assessing cumulative risk, and provides flexibility for addressing a variety of data situations. Because methods and knowledge are expected to continue to evolve in this area, OPP will update specific procedures with peer-reviewed supplementary technical documentation as needed. Further revision of the guidance itself will take place when extensive changes are necessary.

Before undertaking a cumulative risk assessment on pesticides sharing a common mechanism of toxicity, OPP will typically perform an aggregate risk assessment for each chemical in the common-mechanism group. When conducting aggregate assessments, OPP will follow the guidance described in the document entitled “Guidance for Performing Aggregate Exposure and Risk Assessments” (USEPA, 1999b), dated November 16, 2001 (66 FR 59428, November 28, 2001) (FRL-6792-8). Using this guidance, OPP will simultaneously consider the exposures from food, drinking water, and residential/non-occupational uses of each pesticide. When the aggregate risk assessments are completed for individual chemicals that share a common mechanism of toxicity, OPP will perform the cumulative risk assessment in the steps summarized below.

A cumulative risk assessment begins with the identification of a group of chemicals, a common mechanism group (CMG), that induce a common toxic effect by a common mechanism of toxicity. OPP will follow the framework for identifying the chemicals that belong in that group (see “Guidance for Identifying Pesticide Chemicals and Other Substances That Have a Common Mechanism of Toxicity,” USEPA, 1999a (64 FR 5796, February 5, 1999) (FRL-6060-7)). Once a CMG has been established, the next step is to evaluate registered and proposed uses for each CMG member in order to identify potential exposure pathways (i.e., food, drinking water, residential) and routes (i.e., oral, inhalation, dermal). During the hazard characterization phase, the various endpoints associated with the common mechanism of toxicity are identified, as well as the test species/sex that might serve as a uniform basis for determining relative potencies among the chemicals of interest. The common effect is also evaluated to determine if it is expressed across all exposure routes and durations of interest for each CMG member. The temporal aspects (e.g., time to peak effects, time to recovery) of the common mechanism toxicity are characterized to determine the critical window of its expression.

Not all cumulative assessments need to be of the same depth and scope. Thus, early in the cumulative assessment process, it is important to determine the need for, or the capability to perform, a comprehensive risk assessment. This is done by considering the number and types of possible exposure scenarios in conjunction with the associated residue values available. Initial toxicological and exposure information is collected. A screening-level assessment may be conducted that applies more conservative approaches than would a comprehensive and refined cumulative risk assessment. For example, margins of exposure may be based on no-observed adverse-effect-levels (NOAELs) for the common toxic effect rather than modeling dose-response curves of each chemical member to derive more refined relative potencies and points of departures. For dietary food risk, treatment of 100% of crops is assumed for each CMG chemical registered for use on a crop. Tolerance-level residues for the exposure component of the assessment may be assumed, rather than producing a refined estimate of actual residue levels from monitoring. If a screening-level analysis including such overestimates of exposure indicates that there is no risk concern, then no further detailed assessment may be necessary. But if this conservative approach indicates a potential for unacceptable risk, then a refined assessment should be conducted. This may engender the need for additional data.

As the risk assessor proceeds with the cumulative assessment, it is important to determine candidate chemicals and uses, routes, and pathways from the CMG that may cause cumulative effects. Cumulative assessments should not attempt to quantify risk resulting from those common-mechanism chemicals that will have a minimal toxic contribution to the cumulative hazard, or from minor exposure pathways, routes, or uses.

Exposures from minor pathways should be considered qualitatively. Thus, a subset of common-mechanism chemicals to be included in the quantification of cumulative risk needs to be identified from the CMG. This subgroup is called the cumulative assessment group (CAG). The identification of the CAG is done throughout the process as a detailed understanding of each group member's hazard and exposure potential emerges from the analysis. Although a chemical(s) may be removed from the quantification of risk, the rationale for such decisions will be explained. Thus, all chemicals that were grouped by a common mechanism of toxicity will be accounted for (qualitatively or quantitatively) in the final assessment.

OPP will use dose addition for determining the combined risk of the CAG. This approach is consistent with the Agency's approach to multichemical assessments that involve chemicals that are toxicologically similar and share a common toxic effect. OPP will depart from the dose-addition approach if there are data available to support an alternative method. A dose-response analysis is performed on each CAG member to determine its toxic potency for the common toxic effect. The determination of toxic potency should, to the extent feasible with available data, be conducted on a uniform basis (i.e., same measure of potency, for the same effect, from the same test species/sex using studies of comparable methodology).

Once the toxic potency of each common-mechanism chemical is determined, the relative potencies of the CAG members are established. To determine relative potency, a chemical from the CAG is selected to serve as the index chemical. The index chemical is used as the point of reference for standardizing the common toxicity of the other chemical members of the CAG. Once the index chemical is selected, relative potency factors (RPFs) are calculated (i.e., the ratio of the toxic potency of a given chemical relative to that of the index chemical). RPFs are used to convert exposures of all chemicals in the CAG into exposure equivalents of the index chemical. Given that the RPF method portrays risk as exposure equivalents to one chemical (the index compound), it is preferred that index chemical (1) have high-quality dose-response data, (2) have a toxicological/biological profile for the common toxicity that is representative of the common toxic effect(s), and (3) be well characterized for the common mechanism of toxicity. The last step in the dose-response assessment is to calculate a point of departure(s) for the index chemical so that the risk of the CAG can be extrapolated to anticipated human exposures.

Detailed exposure scenarios for all of the uses remaining for each pesticide in the CAG must be developed. This includes determination of potential human exposures by all relevant pathways, durations, and routes that may allow simultaneous exposures, or any sequential exposures among the CAG members that could contribute to the same joint risk of the common toxic effect (i.e., either by overlapping internal doses or by overlapping toxic effects). The framework for estimating combined exposures is based on exposure to individuals, representing differing attributes of the population (e.g., human activity patterns, place of residence, age) that link pathways/route of exposure through scenario building. Cumulative risk values for a given common toxic effect are calculated separately for each exposure route and duration and then combined. To the extent data permit, the temporal and spatial linkages should be maintained for the many factors defining a possible individual exposure. A decision must be made on the relative importance of scenarios and the need for their inclusion in a quantitative assessment, as well as on the populations of interest and locations for evaluation in the assessment. The potential for co-occurrence of possible exposure scenarios is evaluated. Spatial, temporal, and demographic considerations are major factors in determining whether a concurrent exposure is likely to occur. In other words, all exposure events need to occur over a specific interval of time; events need to agree in time, place, and demographic characteristics; and an individual's dose needs to be matched with relevant toxicological values in terms of route and duration.

Exposure input parameters must be established. The magnitude, frequency, and duration for all pertinent exposure pathway/route combinations are determined, and appropriate sources of use/usage information, residues in all appropriate media, and any modifying factors necessary for inclusion in the assessment are identified. Where necessary, any appropriate surrogate datasets from other chemical-specific data, published literature, or generic datasets are identified. A trial run of a quantitative cumulative risk is conducted by assigning route-specific and duration-specific risk metrics. The outputs of this trial run are evaluated and a sensitivity analysis is conducted. Subpopulations of concern are assessed.

The last step of the assessment process is to characterize the risk. The results and conclusions of the cumulative risk analysis are clearly described, including the relative confidence in toxicity and exposure data sources and model inputs. The risk characterization also includes a description of the variability. Major areas of uncertainty are described both qualitatively and quantitatively. The magnitude and direction of likely bias and the impact on the final assessment are discussed. Risk contributors are identified with regard to pesticide(s), pathway, source, time of year, and impacted subpopulation (with particular attention to children). The basis for group uncertainty and FQPA safety factors is explained.

In the event that a cumulative risk assessment indicates that there may be risks of concern, OPP would need to develop risk mitigation measures and take appropriate regulatory actions. OPP notes that the Cumulative Risk Assessment Guidance document does not address the process used to decide on the need for or the choice of risk mitigation measures. It may be possible to address risk concerns through mitigation measures that do not significantly change the use of a pesticide (e.g. reducing application rates or changing the timing or manner of application). In other cases, however, OPP acknowledges that regulatory measures, that reduce or eliminate pesticide uses, may be necessary and may result in the use of other pesticides or alternative pest control practices, which may have their own risks and benefits. While beyond the scope of this science policy document, OPP also recognizes that it is important to consider potential risks and benefits of such substitutes and alternatives to ensure that decisions do not increase net risk, transfer risk unreasonably, and fail to preserve important benefits wherever possible. Such consideration would be an important part in designing mitigation options for aggregate risk assessments for individual chemicals and for cumulative risk assessments for chemicals sharing a common mechanism of toxicity. The consideration of the risks and benefits of alternatives would contribute to an understanding of whether adoption of a possible risk mitigation measure might actually result in increased risks. When alternative means of reducing risk exist, OPP intends that the risk management decisions appropriately take into account which of the mitigation measures achieves the necessary reduction in risk in the most efficient manner, i.e., the manner that has the highest societal benefits. Accordingly, OPP will produce an analysis of alternatives when developing risk reduction options so that the net societal risk and net societal benefits for the options can be estimated. This analysis will enable risk managers to assure that there are not significant risk transfers and uses with important benefits are maintained, to the extent possible.

OPP is interested in understanding the views of the public on these issues— both in the context of making regulatory decisions on specific pesticides and more broadly. OPP's ongoing process of public participation in individual pesticide tolerance reassessment decisions affords ample opportunity for interested stakeholders to comment on these issues as they may affect individual chemicals, classes of chemicals, and the transfer of risks and benefits. In addition, OPP intends to seek public input on broader methodological aspects of these issues through its existing federal advisory committee, the Committee to Advise on Reassessment and Transition, and/or through other avenues that give the public an opportunity to comment. OPP intends to make publicly available the comments received, and to use an open and participatory process to discuss the analysis, methods, and scientific considerations the Agency may use when characterizing changes in net risk, and effects of any transfer of risk and benefits associated with mitigation options.

The policy document discussed in this notice is intended to provide guidance to EPA personnel and decision-makers, and to the public. As a guidance document and not a rule, the policy in this guidance is not binding on either EPA or any outside parties. Although this guidance provides a starting point for EPA risk assessments, EPA will depart from its policy where the facts or circumstances warrant. In such cases, EPA will explain why a different course was taken. Similarly, outside parties remain free to assert that a policy is not appropriate for a specific pesticide or that the circumstances surrounding a specific risk assessment demonstrate that a policy should not be applied.

You may call 202-452-3206 beginning at approximately 5 p.m. two business days before the meeting for a recorded announcement of bank and bank holding company applications scheduled for the meeting; or you may contact the Board's Web site at http://www.federalreserve.gov for an electronic announcement that not only lists applications, but also indicates procedural and other information about the meeting.

The General Services Administration (GSA) has various mission responsibilities related to the acquisition and provision of real property management, and disposal of real and personal property. These mission responsibilities generate requirements that are realized through the solicitation and award of leasing contracts. Individual solicitations and resulting contracts may impose unique information collection/reporting requirements on contractors, not required by regulation, but necessary to evaluate particular program accomplishments and measure success in meeting program objectives.

Respondents: 5016.

Responses Per Respondent: 1.

Total Responses: 5,016.

Total Burden Hours: 25,183.

Requester may obtain a copy of the proposal from the General Services Administration, Regulatory Secretariat (MVP), 1800 F Street, NW., Room 4035, Washington, DC 20405, telephone (202) 501-4744. Please cite OMB Control No. 3090-0086, GSA Form 1364, Proposal to Lease Space (Not Required by Regulation), in all correspondence.

The Office of Government Ethics is the supervising ethics office for the executive branch of the Federal Presidential nominees to executive branch positions subject to Senate confirmation and any other executive branch officials may seek OGE approval for Ethics Act qualified blind or diversified trusts to be used to avoid conflicts of interest.

The Office of Government Ethics is the sponsoring agency for the model certificates and model trust documents for qualified blind and diversified trusts of executive branch officials set up under section 102(f) of the Ethics Act, 5 U.S.C. app. § 102(f), and OGE's implementing financial disclosure regulations at subpart D of 5 CFR part 2634. The various model certificates and model trust documents are utilized by OGE and settlors, trustees and other fiduciaries in establishing and administering these qualified trusts.

On July 3, 2001, OGE issued its first round Federal Register notice to announce its forthcoming request to OMB for paperwork renewal of the updated qualified trust model certificates and model trust documents. See 66 FR 35243-35244, with comments due by September 17, 2001. (OGE did not receive any comments or requests for copies of the updated qualified trust model certificates and model trust documents.) In that notice, and this one, OGE has proposed a minor change to the qualified trust model documents. The Office of Government Ethics has proposed to substitute the words “mailing address” for the words “home address” where they appear within the model trust documents. The proposed change is a minor improvement that will enhance privacy with respect to trust instruments once executed. No change is needed for the model certificates of independence and compliance as codified at appendices A-C to 5 CFR part 2634.

The Office of Government Ethics has submitted updated versions of all twelve qualified trust certificates and model documents described below (all of which are included under OMB paperwork control number 3209-0007, currently cleared through the end of January 2002) for a three-year extension of approval by OMB under the Paperwork Reduction Act (44 U.S.C. chapter 35).

There are two categories of information collection requirements, each with its own related reporting model certificates or model trust documents which are subject to paperwork review and approval by OMB. The OGE regulatory citations for these two categories, together with identification of the forms used for their implementation, are as follows:

i. Qualified trust certifications—5 CFR 2634.401(d)(2), 2634.403(b)(11), 2634.404(c)(11), 2634.406(a)(3) & (b), 2634.408, 2634.409 and appendixes A & B to part 2634 (the two implementing forms, the Certificate of Independence and Certificate of Compliance, are codified respectively in the cited appendixes; see also the Privacy Act and Paperwork Reduction Act notices thereto in appendix C); and

ii. Qualified trust communications and model provisions and agreements—5 CFR 2634.401(c)(1)(i) & (d)(2), 2634.403(b), 2634.404(c), 2634.408 and 2634.409 (the ten implementing forms are the: (A) Blind Trust Communications (Expedited Procedure for Securing Approval of Proposed Communications); (B) Model Qualified Blind Trust Provisions; (C) Model Qualified Diversified Trust Provisions; (D) Model Qualified Blind Trust Provisions (For Use in the Case of Multiple Fiduciaries); (E) Model Qualified Blind Trust Provisions (For Use in the Case of an Irrevocable Pre-Existing Trust); (F) Model Qualified Diversified Trust Provisions (Hybrid Version); (G) Model Qualified Diversified Trust Provisions (For Use in the Case of Multiple Fiduciaries); (H) Model Qualified Diversified Trust Provisions (For Use in the Case of an Irrevocable Pre-Existing Trust); (I) Model Confidentiality Agreement Provisions (For Use in the Case of a Privately Owned Business); and (J) Model Confidentiality Agreement Provisions (For Use in the Case of Investment Management Activities)).

The various model trust certificates and model trust documents as proposed to be modified are available without charge to the public upon request as indicated in the “For Further Information Contact” section above.

The communications formats and the confidentiality agreements (items ii (A), (I) and (J) above) would not be available to the public because they contain sensitive, confidential information. All the other completed model trust certificates and model trust documents (except for any trust provisions that relate to the testamentary disposition of trust assets) are publicly available based upon a proper Ethics Act request (by filling out an OGE Form 201 access form).

The total annual public reporting burden represents the time involved for completing qualified trust certificates and model trust documents which are processed by OGE. The burden is based on the amount of time imposed on private citizens. Virtually all filers/document users are private trust administrators and other private representatives who help to set up and maintain the qualified blind and diversified trusts. The detailed paperwork estimates below for the various trust certificates and model trust documents, which remain the same as for the last paperwork clearance three years ago, are based primarily on OGE's experience with administration of the qualified trust program.

A. Certificate of Independence: Total filers (executive branch): 10; Private citizen filers (100%): 10; OGE-processed certificates (private citizens): 10; OGE burden hours (20 minutes/certificate): 3.

B. Certificate of Compliance: Total filers (executive branch): 35; Private citizen filers (100%): 35; OGE-processed certificates (private citizens): 35; OGE burden hours (20 minutes/certificate): 12; and

A. Blind Trust Communications: Total Users (executive branch): 35; Private citizen users (100%): 35; OGE-processed documents (private citizens): 210 (based on an average of six communications per user, per year); OGE burden hours (20 minutes/communication): 70.

B. Model Qualified Blind Trust: Total Users (executive branch): 10; Private citizen users (100%): 10; OGE-processed models (private citizens): 10; OGE burden hours (100 hours/model): 1,000.

C. Model Qualified Diversified Trust: Total users (executive branch): 15; Private citizen users (100%): 15; OGE-processed models (private citizens): 15; OGE burden hours (100 hours/model): 1,500.

D.-H. Each of the five remaining model qualified trust documents: Total users (executive branch): 2; Private citizen users (100%): 2; OGE-processed models (private citizens): 2, multiplied by 5 (five different models) = 10; OGE burden hours (100 hours/model): 200, multiplied by 5 (five different models) = 1,000.

I.-J. Each of the two model confidentiality agreements: Total users (executive branch): 2; Private citizens users (100%): 2; OGE-processed agreements (private citizens): 2, multiplied by 2 (two different models) = 4; OGE burden hours (50 hours/agreement): 100, multiplied by 2 (two different models) = 200.

Based on these estimates, the total number of forms expected annually at OGE remains unchanged at 294 with a cumulative total of 3,785 burden hours.

In this second round notice, public comment is again invited on all aspects of OGE's qualified trust model certificates and model trust documents as proposed for renewal with minor revision, including specifically views on: the accuracy of OGE's public burden estimate; the potential for enhancement of quality, utility, and clarity of the information to be collected; and the minimization of burden (including the possibility of use of information technology). The Office of Government Ethics, in consultation with OMB, will consider all comments received, which will become a matter of public record.

CMS proposes to initiate a new SORs collecting data under the authority of section 1875(a) (42 U.S.C. 1395ll) and section 1115 (42 U.S.C. 1315) of the Social Security Act. The EMRD SOR will provide data necessary to evaluate CMS's Evaluations of the Medicaid Reform Demonstrations. As part of this effort, individually identifiable data will be used to analyze the effects of the demonstration on beneficiary eligibility, access to care, utilization, health care costs, satisfaction with care, quality of care, and health status. The information retrieved from this SOR will be used: (1) To support program administration, reporting, and regulatory, reimbursement, and policy functions performed within the Centers for Medicare & Medicaid Services (CMS) or by a contractor or consultant; (2) to enable another Federal or State agency to contribute to the accuracy of the CMS's proper payment of Medicaid, State Children's Health Insurance Program and Medicare benefits; (3) to enable CMS to administer a Federal health benefits program or to enable CMS to fulfill a requirement of a Federal statute or regulation that implements a health benefits program funded in whole or in part with Federal funds; (4) to support constituent requests made by a Congressional representative; (5) to support litigation involving the Agency; (6) to support program administration, reporting, research, evaluation, and related issues; (7) and to disclose individual-specific information for the purpose of combating fraud and abuse in health benefits programs administered by CMS.

As of September 1, 1999, 21 section 1115 waivers for demonstrations in the following States have been approved and implemented: Alabama (Mobile County only), Arizona, Arkansas, California (Los Angeles County only), Delaware, District of Columbia, Florida, Hawaii, Kentucky, Maryland, Massachusetts, Minnesota, New Jersey, New York, Ohio, Oklahoma, Oregon, Rhode Island, Tennessee, Vermont and Wisconsin.

CMS has awarded a number of contracts to independent evaluators to assess the demonstrations thus far. These evaluations include:

Evaluation of the State Health Reform Demonstrations (Contract Number 500-94-0047)—Awarded to prime contractor Mathematica Policy Research, Inc. and subcontractors.

Examines the impact of five State Medicaid reform demonstrations (Hawaii, Maryland, Oklahoma, Rhode Island, and Tennessee).

Evaluation of the Medicaid Health Reform Demonstrations (Contract Number 500-95-0040) Awarded to Urban Institute and its subcontractors.

Examines five health reform demonstrations (California (Los Angeles County only), Kentucky, Minnesota, New York, and Vermont).

Evaluation of the Oregon Medicaid Reform Demonstration (Contract Number 500-94-0056)—Awarded to Health Economics Research, Inc. and subcontractors.

Examines the impacts of the Oregon Medicaid Reform Demonstration.

Evaluation of Delaware's Diamond State Health Plan (500-92-0033 Delivery Order Nos. 1 and 4)—Awarded to Research Triangle Institute and subcontractors.

Examines the impacts of the Delaware demonstration, with particular emphasis on children, including children with special health care needs.

Evaluation of Mass Health Quality Improvement Plan and Insurance Reimbursement Program (Contract Number 500-95-0058/T.O. #9)—Awarded to Health Economics Research, Inc. and subcontractors.

The evaluation will consist of two parts: (1) A case study of the quality improvement process in Medicaid MCOs and PCCs; (2) A case study of the implementation of the Insurance Reimbursement Program for low-income families.

Evaluation of the District of Columbia's Demonstration Project, “Managed Care System for Disabled and Special Needs Children” (Contract Number 500-96-0003)—Awarded to Abt Associates, Inc. and subcontractors.

The goal of this project is to document and analyze the experiences of the District of Columbia's managed care system for children and adolescents under the age of 22 who are eligible for Medicaid and who are considered disabled according to Supplemental Security Income (SSI) Program guidelines.

Focused Evaluation of Ohio Section 1115 State Health Reform Demonstration: Behavioral Health (Contract Number 500-97-0022)—Awarded to Heath Economics Research, Inc. and subcontractors.

This evaluation will consist of the following two components: (1) A focused evaluation of the behavioral health component of OhioCare, Ohio's section 1115 State health reform demonstration; and (2) A case study of the implementation of OhioCare.

Additional contracts will be awarded to evaluate other demonstrations as they are approved.

1. Each evaluation conducts analyses to answer the following broad questions for participants, individuals, employers or other relevant parties; or nonparticipant comparison populations from the pre-demonstration period, during the demonstration, and post-demonstration period.

2. How were the demonstrations implemented, and what processes were put in place to administer them. Are these processes effective?

3. What are the impacts of the demonstrations on eligibility and access to care?

4. What are the demonstrations' impacts on quality, including health status impacts, the process of care delivered, and satisfaction with care received?

5. What are the impacts of the demonstrations on the utilization of services?

6. What are the impacts of the demonstrations on cost, from Federal, State, provider, employer, and beneficiary perspectives?

As part of these efforts, the contractors will use individually identifiable data from state administrative data bases (including, but not, limited to, Medicaid eligibility, claims and encounter data), CMS data bases, data from other Federal and State agencies (including, but not limited to, the Social Security Administration), and other relevant data bases, surveys and vital records to analyze the effects of the demonstration on beneficiary eligibility, access to care, health care costs, satisfaction with care, and health status. CMS and the contractor will collect only that information necessary to perform the system's function.

The SOR is expected to include data on the number and type of services used by demonstration participants and comparison group members and their experiences in accessing health care before, during, and after the demonstration period. Sources of information contained in this records system are expected to include: State Medicaid Management Information Systems, managed care organizations (i.e., encounter data), fee-for-service providers, surveys of demonstration participants or providers and comparison group members, medical records, Social Security Administration data bases, vital statistics, and other relevant data systems.

The Privacy Act permits us to disclose information without an individual's consent if the information is to be used for a purpose that is compatible with the purpose(s) for which the information was collected. Any such disclosure of data is known as a “routine use.” The government will only release EMRD information that can be associated with an individual patient as provided for under “Section III. Entities Who May Receive Disclosures Under Routine Use.” Both identifiable and non-identifiable data may be disclosed under a routine use. Identifiable data includes individual records with EMRD information and identifiers. Non-identifiable data includes individual records with EMRD information and masked identifiers or EMRD information with identifiers stripped out of the file.

We will only disclose the minimum personal data necessary to achieve the purpose of the EMRD. CMS has the following policies and procedures concerning disclosures of information that will be maintained in the system. In general, disclosure of information from the SOR will be approved only for the minimum information necessary to accomplish the purpose of the disclosure after CMS:

1. Determines that the use or disclosure is consistent with the reason that the data is being collected; e.g., to evaluate the effects of the demonstration on beneficiaries eligibility, access to care, utilization, health care costs, satisfaction with care; quality of care, and health status.

1. Determines that:

a. The purpose for which the disclosure is to be made can only be accomplished if the record is provided in individually identifiable form;

b. The purpose for which the disclosure is to be made is of sufficient importance to warrant the effect and/or risk on the privacy of the individual that additional exposure of the record might bring; and

c. There is a strong probability that the proposed use of the data would in fact accomplish the stated purpose(s).

3. Requires the information recipient to:

a. Establish administrative, technical, and physical safeguards to prevent

b. Unauthorized use of disclosure of the record;

c. Remove or destroy at the earliest time all patient-identifiable information; and

d. Agree to not use or disclose the information for any purpose other than the stated purpose under which the information was disclosed.

4. Determines that the data are valid and reliable.

These routine uses specify circumstances, in addition to those provided by statute in the Privacy Act of 1974, under which CMS may release information from the EMRD without the consent of the individual to whom such information pertains. Each proposed disclosure of information under these routine uses will be evaluated to ensure that the disclosure is legally permissible, including but not limited to ensuring that the purpose of the disclosure is compatible with the purpose for which the information was collected.

We are proposing to establish the following routine use disclosures of information maintained in the system:

1. To agency contractors or consultants who have been contracted by the agency to assist in the performance of a service related to this system of records and who need to have access to the records in order to perform the activity.

We contemplate disclosing information under this routine use only in situations in which CMS may enter into a contractual or similar agreement with a third party to assist in accomplishing agency business functions relating to purposes for this system of records.

CMS occasionally contracts out certain of its functions when doing so would contribute to effective and efficient operations. CMS must be able to give a contractor whatever information is necessary for the contractor to fulfill its duties. In these situations, safeguards are provided in the contract prohibiting the contractor from using or disclosing the information for any purpose other than that described in the contract and requires the contractor to return or destroy all information at the completion of the contract.

2. To the Agency of a state or local government, or established by state law, for purposes of ensuring that no payments are made with respect to any item or service furnished by an individual or entity during the period when such individual or entity is excluded from participation in Medicaid, SCHIP, Medicare or other Federal and State health care programs. Data will be released to the State only on those individuals who are either individuals or entities excluded from participation in Medicaid, SCHIP, Medicare, or other Federal and State health care programs, or employers of excluded individuals or entities, or are legal residents of the State, irrespective of the location of a provider or supplier furnishing items or services.

Program evaluation relies, in large part, on program integrity and the integrity of collected data, the routine use proposed in this paragraph is a necessary requirement for this database, and is therefore, compatible with the purpose for which the information is being collected.

3. To another Federal or state agency:

a. To contribute to the accuracy of CMS's proper payment of Medicaid, SCHIP, or Medicare benefits,

b. To enable such agency to administer a Federal health benefits program, or as necessary to enable such agency to fulfill a requirement of a Federal statute or regulation that implements a health benefits program funded in whole or in part with Federal funds, or

c. To fulfill reporting requirements, research, evaluation, or other policy or epidemiological considerations.

CMS, and other Federal or state and local agencies, all contribute data to the databases included in this SOR, and (both separately and jointly) have an interest in performing program evaluation, conducting research and maintaining program integrity. Therefore, the routine uses described herein are compatible with the purpose for which the data are being collected.

4. To an individual or other private or public entity for research, evaluation or epidemiological projects related to the prevention of disease or disability, the restoration or maintenance of health, or for projects designed to increase the efficiency and economy of care provision.

The EMRD data will provide an opportunity for comprehensive research, evaluation and epidemiological projects regarding EMRD patients. CMS anticipates that many researchers will have legitimate requests to use these data in projects that could ultimately improve the care provided to Medicaid, SCHIP and Medicare beneficiaries and the policy that governs the care.

5. To a Member of Congress or to a congressional staff member in response to an inquiry of the Congressional Office made at the written request of the constituent about whom the record is maintained.

Beneficiaries sometimes request the help of a Member of Congress in resolving some issue relating to a matter before CMS. The Member of Congress then writes CMS, and CMS must be able to give sufficient information to be responsive to the inquiry.

6. To the Department of Justice (DOJ), court or adjudicatory body when:

a. The agency or any component thereof, or

b. Any employee of the agency in his or her official capacity; or

c. Any employee of the agency in his or her individual capacity where the DOJ has agreed to represent the employee, or

d. The United States Government;

Whenever CMS is involved in litigation, or occasionally when another party is involved in litigation and CMS's policies or operations could be affected by the outcome of the litigation, CMS would be able to disclose information to the DOJ, court or adjudicatory body involved. A determination would be made in each instance that, under the circumstances involved, the purposes served by the use of the information in the particular litigation is compatible with a purpose for which CMS collects the information.

7. To CMS or State contractors, to administer some aspect of the health benefits programs, or to a CMS grantee or program which is or could be affected by fraud and abuse, for the purpose of preventing, deterring, discovering, detecting, investigating, examining, prosecuting, suing with respect to, defending against, correcting, remedying, or otherwise combating such fraud and abuse in such programs.

CMS contemplates disclosing information under this routine use only in situations in which CMS may enter into a contractual or similar agreement with a third party to assist in accomplishing CMS functions relating to purposes for this SORs.

CMS occasionally contracts out certain of its functions when this would contribute to effective and efficient operations. CMS must be able to give a contractor whatever information is necessary for the contractor to fulfill its duties. In these situations, safeguards (like ensuring that the purpose for which the disclosure is to be made is of sufficient importance to warrant the effect and/or risk on the privacy of the individual that additional exposure of the record might bring and those stated in II.B above), are provided in the contract prohibiting the contractor from using or disclosing the information for any purpose other than that described in the contract and to return or destroy all information.

Program evaluation relies, in large part, on program integrity and the integrity of collected data, the routine use proposed in this paragraph is a necessary requirement for this database, and is therefore, compatible with the purpose for which the information is being collected.

8. To another Federal agency or to an instrumentality of any governmental jurisdiction within or under the control of the United States, including any State or Local government agency, for the purpose of preventing, deterring, discovering, detecting, investigating, examining, prosecuting, suing with respect to, defending against, correcting, remedying, or otherwise combating such fraud and abuse in health benefits program funded in whole or in part by Federal funds.

Other State or local agencies in their administration of a Federal health program may require EMRD information for the purpose of preventing, deterring, discovering, detecting, investigating, examining, prosecuting, suing with respect to, defending against, correcting, remedying, or otherwise combating such fraud and abuse in such programs. Releases of information would be allowed if the proposed use(s) for the information proved compatible with the purpose for which CMS collects the information.

Program evaluation relies, in large part, on program integrity and the integrity of collected data, the routine use proposed in this paragraph is a necessary requirement for this database, and is therefore, compatible with the purpose for which the information is being collected.

In addition, our policy will be to prohibit release even of non-identifiable data, except pursuant to one of the routine uses, if there is a possibility that an individual can be identified through implicit deduction based on small cell sizes (instances where the patient population is so small that individuals who are familiar with the enrollees could, because of the small size, use this information to deduce the identity of the beneficiary).

This System of Records contains Protected Health Information as defined by the Department of Health and Human Services' regulation “Standards for Privacy of Individually Identifiable Health Information” (45 CFR parts 160 and 164, 65 FR 82462 as amended by 66 FR 12434). Disclosures of Protected Health Information authorized by these routine uses may only be made if, and as, permitted or required by the “Standards for Privacy of Individually Identifiable Health Information.”

The HHS EMRD system will conform to applicable law and policy governing the privacy and security of Federal automated information systems. These include but are not limited to: the Privacy Act of 1984, Computer Security Act of 1987, the Paperwork Reduction Act of 1995, the Clinger-Cohen Act of 1996, and OMB Circular A-130, Appendix III, “Security of Federal Automated Information Resources.” CMS has prepared a comprehensive system security plan as required by OMB Circular A-130, Appendix III. This plan conforms fully to guidance issued by the National Institute for Standards and Technology (NIST) in NIST Special Publication 800-18, “Guide for Developing Security Plans for Information Technology Systems.” Paragraphs A-C of this section highlight some of the specific methods that CMS is using to ensure the security of this system and the information within it.

Personnel having access to the system have been trained in Privacy Act requirements. Employees who maintain records in the system are instructed not to release any data until the intended recipient agrees to implement appropriate administrative, technical, procedural, and physical safeguards sufficient to protect the confidentiality of the data and to prevent unauthorized access to the data. Records are used in a designated work area and system location is attended at all times during working hours.

To ensure security of the data, the proper level of class user is assigned for each individual user level. This prevents unauthorized users from accessing and modifying critical data. The system database configuration includes five classes of database users:

• Database Administrator class owns the database objects (e.g., tables, triggers, indexes, stored procedures, packages) and has database administration privileges to these objects.

• Quality Control Administrator class has read and write access to key fields in the database;

• Quality Index Report Generator class has read-only access to all fields and tables;

• Policy Research class has query access to tables, but are not allowed to access confidential patient identification information; and

• Submitter class has read and write access to database objects, but no database administration privileges.

All server sites will implement the following minimum requirements to assist in reducing the exposure of computer equipment and thus achieve an optimum level of protection and security for the CMS system:

Access to all servers is to be controlled, with access limited to only those support personnel with a demonstrated need for access. Servers are to be kept in a locked room accessible only by specified management and system support personnel. Each server is to require a specific log-on process. All entrance doors are identified and marked. A log is kept of all personnel who were issued a security card, key and/or combination, which grants access to the room housing the server, and all visitors are escorted while in this room. All servers are housed in an area where appropriate environmental security controls are implemented, which include measures implemented to mitigate damage to Automated Information Systems (AIS) resources caused by fire, electricity, water and inadequate climate controls.

Protection applied to the workstations, servers and databases include:

• User Log-on—Authentication is to be performed by the Primary Domain Controller/Backup Domain Controller of the log-on domain.

• Workstation Names—Workstation naming conventions may be defined and implemented at the agency level.

• Hours of Operation—May be restricted by Windows NT. When activated all applicable processes will automatically shut down at a specific time and not be permitted to resume until the predetermined time. The appropriate hours of operation are to be determined and implemented at the agency level.

• Inactivity Lockout—Access to the NT workstation is to be automatically locked after a specified period of inactivity.

• Warnings—Legal notices and security warnings are to be displayed on all servers and workstations.

• Remote Access Security—Windows NT Remote Access Service (RAS) security handles resource access control. Access to NT resources is to be controlled for remote users in the same manner as local users, by utilizing Windows NT file and sharing permissions. Dial-in access can be granted or restricted on a user-by-user basis through the Windows NT RAS administration tool.

All automated systems must comply with Federal laws, guidance, and policies for information systems security. These include, but are not limited to: the Privacy Act of 1974; the Computer Security Act of 1987; OMB Circular A-130, revised; Information Resource Management (IRM) Circular #10; HHS Automated Information Systems Security Program; the CMS Information Systems Security Policy, Standards, and Guidelines Handbook; and other CMS systems security policies. Each automated information system should ensure a level of security commensurate with the level of sensitivity of the data, risk, and magnitude of the harm that may result from the loss, misuse, disclosure, or modification of the information contained in the system.

CMS proposes to establish this system in accordance with the principles and requirements of the Privacy Act and will collect, use, and disseminate information only as prescribed therein. Data in this system will be subject to the authorized releases in accordance with the routine uses identified in this system of records.

CMS will monitor the collection and reporting of EMRD data. EMRD information on patients is submitted to CMS through standard systems. Accuracy of the data is important since incorrect information could result in the wrong payment for services and a less effective process for assuring quality of services. CMS will utilize a variety of onsite and offsite edits and audits to increase the accuracy of EMRD data.

CMS will take precautionary measures (see item IV. above) to minimize the risks of unauthorized access to the records and the potential harm to individual privacy or other personal or property rights of patients whose data is maintained in the system. CMS will collect only that information necessary to perform the system's functions. In addition, CMS will make disclosure from the proposed system only with consent of the subject individual, or his/her legal representative, or in accordance with an applicable exception provision of the Privacy Act.

CMS, therefore, does not anticipate an unfavorable effect on individual privacy as a result of maintaining this system of records.

PDUFA (Public Law 102-571), as amended by FDAMA (Public Law 105- 115), referred to as PDUFA II in this document, establishes three different kinds of user fees. Fees are assessed on: (1) Certain types of applications and supplements for approval of drug and biological products, (2) certain establishments where such products are made, and (3) certain products (21 U.S.C. 379h(a)). When certain conditions are met, FDA may waive or reduce fees (21 U.S.C. 379h(d)).

For FY 1998 through 2002, under PDUFA II, the application fee rates are set in the statute, but are to be adjusted annually for cumulative inflation since FY 1997. Total application fee revenues are structured to increase or decrease each year as the number of fee-paying applications submitted to FDA increases or decreases.

Each year from FY 1998 through 2002, FDA is required to set establishment fees and product fees so that the estimated total fee revenue from each of these two categories will equal the total revenue FDA expects to collect from application fees that year. This procedure continues the arrangement under which one-third of the total user fee revenue is projected to come from each of the three types of fees: Application fees, establishment fees, and product fees.

This notice establishes fee rates for FY 2002 for application, establishment, and product fees. These fees are retroactive to October 1, 2001, and will remain in effect through September 30, 2002. For fees already paid on applications and supplements submitted on or after October 1, 2001, FDA will bill applicants for the difference between fees paid and fees due under the new fee schedule. For applications and supplements submitted after January 16, 2002, the new fee schedule must be used. Invoices for establishment and product fees for FY 2002 will be issued in January 2002, using the new fee schedule.

PDUFA II provides that fee rates for each FY shall be adjusted by notice in the Federal Register . The adjustment must reflect the greater of : (1) The total percentage change that occurred during the preceding FY in the Consumer Price Index (CPI) (all items; U.S. city average), or (2) the total percentage pay change for that FY for Federal employees stationed in the Washington, DC metropolitan area. PDUFA II provides for this annual adjustment to be cumulative and compounded annually after 1997 (see 21 U.S.C. 379h(c)(1)).

PDUFA II also structures the total application fee revenue to increase or decrease each year as the number of fee-paying applications submitted to FDA increases or decreases. This provision allows revenues to rise or fall as this portion of FDA's workload rises or falls. To implement this provision, each year FDA will estimate the number of fee-paying applications it anticipates receiving. The number of applications estimated will then be multiplied by the inflation-adjusted statutory application fee. This calculation will produce the FDA estimate of total application fee revenues to be received.

PDUFA II also provides that FDA shall adjust the rates for establishment and product fees so that the total revenues from each of these categories is projected to equal the revenues FDA expects to collect from application fees that year. PDUFA II provides that the new fee rates based on these calculations be adjusted within 60 days after the end of each FY (21 U.S.C. 379h(c)(2)).

PDUFA II provides that the application fee rates set out in the statute be adjusted each year for cumulative inflation since 1997. It also provides for total application fee revenues to increase or decrease based on increases or decreases in the number of fee-paying applications submitted.

Application fees are assessed at different rates for qualifying applications depending on whether the applications require clinical data for safety or effectiveness (other than bioavailability or bioequivalence studies) (21 U.S.C. 379h(a)(1)(A) and 379h(b)). Applications that require clinical data are subject to the full application fee. Applications that do not require clinical data and supplements that require clinical data are assessed one-half the fee of applications that require clinical data. If FDA refuses to file an application or supplement, 75 percent of the application fee is refunded to the applicant (21 U.S.C. 379h(a)(1)(D)).

The application fees described above are set out in PDUFA II for FY 2002 ($258,451 for applications requiring clinical data, and $129,226 for applications not requiring clinical data or supplements requiring clinical data) (21 U.S.C. 379h(b)(1)), but must be adjusted for cumulative inflation since 1997. That adjustment each year is to be the greater of: (1) The total percentage change that occurred during the preceding FY in the CPI, or (2) the total percentage pay change for that FY for Federal employees stationed in the Washington, DC metropolitan area, as adjusted for any locality-based payment. PDUFA II provides for this annual adjustment to be cumulative and compounded annually after 1997 (see 21 U.S.C. 379h(c)).

The adjustment for FY 1998 was 2.45 percent (62 FR 64849, December 9, 1997). This was the greater of the CPI increase for FY 1997 (2.15 percent) or the increase in applicable Federal salaries (2.45 percent).

The adjustment for FY 1999 was 3.68 percent. (63 FR 70777 at 70778, December 22, 1998). This was the greater of the CPI increase for FY 1998 (1.49 percent) or the increase in applicable Federal salaries (3.68 percent).

The adjustment for FY 2000 was 4.94 percent (64 FR 72669 at 72670, December 28, 1999). This was the greater of the CPI increase for FY 1999 (2.62 percent) or the increase in applicable Federal salaries (4.94 percent).

The adjustment for FY 2001 was 3.81 percent (65 FR 79107 at 79108, December 18, 2000). This was the greater of the CPI increase for FY 2000 (2.62 percent) or the increase in applicable Federal salaries (3.81 percent).

The adjustment for FY 2002 is 4.77 percent. This is the greater of the CPI increase for FY 2001 (2.65 percent) or the increase in applicable Federal salaries (4.77 percent).

Compounding these amounts (1.0245 times 1.0368 times 1.0494 times 1.0381 times 1.0477) yields a total compounded inflation increase of 21.23 percent for FY 2002. The adjusted application fee rates are computed by adding one to the decimal equivalent of this percent (0.2123) and multiplying this amount (1.2123) by the FY 2002 statutory application fee rates stated above ($258,451 for applications requiring clinical data, and $129,226 for applications not requiring clinical data or supplements requiring clinical data). For FY 2002 the adjusted application fee rates are $313,320 for applications requiring clinical data, and $156,660 for applications not requiring clinical data or supplements requiring clinical data. These amounts must be submitted with all applications during FY 2002.

Total application fee revenues for FY 2002 will be estimated by multiplying the number of fee-paying applications FDA expects to receive in FY 2002 (from October 1, 2001, through September 30, 2002) by the fee rates calculated in the preceding paragraph. Before fees can be set for establishment and product fee categories, each of which are projected to be equal to total revenues FDA collects from application fees, FDA must first estimate its total FY 2002 application fee revenues. To do this FDA first determines its FY 2001 fee-paying full application equivalents, and uses that number in a linear regression analysis to predict the number of fee-paying full application equivalents expected in FY 2002. This is the same technique applied in each of the previous 3 fiscal years.

In FY 2001, FDA received and filed 95 human drug applications that require clinical data for approval, 16 that did not require clinical data for approval, and 126 supplements to human drug applications that required clinical data for approval. Because applications that do not require clinical data and supplements that require clinical data are assessed only one-half the full fee, the equivalent number of these applications subject to the full fee is determined by summing these categories and dividing by 2. This amount is then added to the number of applications that require clinical data to arrive at the equivalent number of applications that may be subject to full application fees.

In addition, as of September 30, 2000, FDA refused to file, or firms withdrew before filing, 2 applications that required clinical data, and 5 applications that either did not require clinical data or that were supplements requiring clinical data. The full applications refused for filing or withdrawn before filing pay one-fourth the full application fee and are counted as one-fourth of an application; the applications that do not require clinical data and the supplements refused for filing or withdrawn before filing pay one-eighth of the full application fee and are each counted as one-eighth of an application.

Using this methodology, the number of full application equivalent (FAE) submissions that were received for review in FY 2001 was 167.125, before any exemptions, waivers or reductions. Under PDUFA II, FDA waives application fees for certain small businesses submitting their first application and for certain orphan products. Certain application supplements for pediatric indications are also exempt from fees. In addition, PDUFA II provides a number of other grounds for waivers (public health necessity, preventing significant barriers to innovation, and fees exceed the cost). In FY 2001 waivers or exemptions were applied to 59 FAE submissions (14.5 for orphan products, 12 for small businesses, 19 for pediatric supplements, and 13.5 miscellaneous exemptions/waivers). Therefore, for FY 2001, FDA estimates that it received 108.125 (167.125 minus 59) FAE submissions that will pay fees, after allowing for exemptions, waivers and reductions.

Next a linear regression line based on the adjusted number of fee-paying FAE submissions since 1993, and including our FY 2001 total of FAEs, must be drawn to project the number of FAEs in FY 2002.

In FY 2002, however, additional applications will have to pay fees. All pediatric supplements will be required to pay fees effective January 4, 2002 (for three-fourths of FY 2002). This is the result of section 5 of the Best Pharmaceuticals for Children Act. It repealed the fee exemption for pediatric supplements effective January 4, 2002. Thus, the regression line projecting FY 2002 fee-paying receipts must be drawn to reflect this change. In FY 1998, 8 full fees were exempted for pediatric supplements; the numbers for FY 1999, FY 2000, and FY 2001 respectively were 5.25, 12.5, and 19. Since fees on these supplements will only be paid for three-fourths of FY 2002 (January 1 through September 30, 2002), three-fourths of the number of pediatric supplements waived each year from FY 1998 through FY 2001 (the only years when fees were waived) will be added to the total of fee-paying FAEs received each year.

A linear regression line based on this adjusted number of fee-paying FAE submissions since 1993, and including our adjusted FY 2001 total of 122.375 FAEs (108.125 fee-paying FAEs and three-fourths of the 19 pediatric supplements that were exempted in FY 2001), projects the receipt of 158.3 fee-paying FAEs in FY 2002, as reflected in table 1 of this document and the graph below.

The total FY 2002 application fee revenue is estimated by multiplying the adjusted application fee rate ($313,320) by the number of applications projected to qualify for fees in FY 2002 (158.3), for a total estimated application fee revenue in FY 2001 of $49,598,556. This is the amount of revenue that FDA is also expected to derive both from establishment fees and from product fees.

Under the provisions of PDUFA II, if the agency collects more fees than were provided for in appropriations in any year after 1997, FDA is required to reduce its anticipated fee collections in a subsequent year by that amount (21 U.S.C. 379h(g)(4)).

In FY 1998, Congress appropriated a total of $117,122,000 to FDA in PDUFA II fee revenue. To date, collections for FY 1998 total $117,737,470---a total of $615,470 in excess of the appropriation limit. This is the only fiscal year since 1997 in which FDA has collected more in PDUFA II fees than Congress appropriated.

FDA also has requests for waivers or reductions of FY 1998 fees pending. For this reason FDA is not reducing its FY 2002 fees to offset excess collections at this time. An offset will be considered in a future year, if FDA still has collections in excess of appropriations for FY 1998 after the pending requests for FY 1998 waivers and reductions have been resolved.

At the beginning of FY 2001, the establishment fee was based on an estimate of 347 establishments subject to fees. For FY 2001, 379 establishments qualified for and were billed for establishment fees, before all decisions on requests for waivers or reductions were made. FDA estimates that a total of 25 establishment fee waivers or reductions will be made for FY 2001, for a net of 354 fee-paying establishments, and will use this number for its FY 2002 estimate of establishments paying fees, after taking waivers and reductions into account. The fee per establishment is determined by dividing the adjusted total fee revenue to be derived from establishments ($49,598,556), by the estimated 354 establishments, for an establishment fee rate for FY 2002 of $140,109 (rounded to the nearest dollar).

At the beginning of FY 2001, the product fee was based on an estimate that 2,314 products would be subject to product fees. By the end of FY 2001, 2,348 products qualified and were billed for product fees before all decisions on requests for waivers or reductions were made. Assuming that there will be about 55 waivers and reductions made, FDA estimates that 2,293 products will qualify for product fees in FY 2002, after allowing for waivers and reductions, and will use this number for its FY 2002 estimate. Accordingly, the FY 2002 product fee rate is determined by dividing the adjusted total fee revenue to be derived from product fees ($49,598,556) by the estimated 2,293 products for a product fee rate of $21,630 (rounded to the nearest dollar).

The fee rates for FY 2002 are set out in table 2 of this document:

Any application or supplement subject to fees under PDUFA II that is submitted after January 16, 2002, must be accompanied by the appropriate application fee established in the new fee schedule. Payment must be made in U.S. currency by check, bank draft, or U.S. postal money order payable to the order of the Food and Drug Administration. Please include the user fee ID number on your check. Your check can be mailed to: Food and Drug Administration, P.O. Box 360909, Pittsburgh, PA 15251-6909.

If checks are to be sent by a courier that requests a street address, the courier can deliver the checks to: Food and Drug Administration (360909), Mellon Client Service Center, rm. 670, 500 Ross St., Pittsburgh, PA 15262-0001. (Note: This Mellon Bank Address is for courier delivery only.)

Please make sure that the FDA P.O. Box number (P.O. Box 360909) is on the enclosed check.

FDA will bill applicants who submitted lower application fees from October 1 to January 16, 2002, for the difference between the amount they submitted and the amount specified in the Adjusted Fee Schedule for FY 2002.

By [ insert date of publication in the Federal Register ], FDA will issue invoices for establishment and product fees for FY 2002 under the new Adjusted Fee Schedule. Payment will be due by January 31, 2002. FDA will issue invoices for any products and establishments subject to fees for FY 2002 that qualify for fees after the January 2002 billing.

FDA is announcing the availability of a document entitled “Guidance for Industry: Revised Preventive Measures to Reduce the Possible Risk of Transmission of Creutzfeldt-Jakob Disease (CJD) and Variant Creutzfeldt-Jakob Disease (vCJD) by Blood and Blood Products” dated January 2002. This guidance document contains comprehensive revised recommendations based upon advisory committee discussions, internal Public Health Service and FDA deliberations, and public comments. FDA has developed recommendations for donor deferral, and product retrieval, quarantine, and disposition based upon consideration of risk in the donor and product, and the effect that withdrawals and deferrals might have on the supply of life- and health-sustaining blood components and plasma derivatives. The new recommendations are intended to minimize the possible risk of CJD and vCJD transmission from blood products while maintaining their availability. The guidance document announced in this notice finalizes the draft guidance of the same title, dated August 2001, announced in the Federal Register of August 29, 2001 (66 FR 45683). The guidance document also supersedes the guidance document entitled “Revised Preventive Measures to Reduce the Possible Risk of Transmission of Creutzfeldt-Jakob Disease (CJD) and New Variant Creutzfeldt-Jakob Disease (nvCJD) by Blood and Blood Products” dated November 1999 (64 FR 65715, November 23, 1999).

This guidance is being issued consistent with FDA’s good guidance practices regulation (21 CFR 10.115). This guidance document represents the agency's current thinking on this topic. 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 requirement of the applicable statutes and regulations.

Interested persons may, at any time, submit written comments to the Dockets Management Branch (address above) regarding this guidance document. Two copies of any comments are to be submitted, except individuals may submit one copy. Comments should be identified with the docket number found in the brackets in the heading of this document. A copy of the document and received comments are available for public examination in the Dockets Management Branch between 9 a.m. and 4 p.m., Monday through Friday.

Persons with access to the Internet may obtain the document at either http://www.fda.gov/cber/guidelines.htm or http://www.fda.gov/ohrms/dockets/default.htm.

The Department is submitting the proposed information collection to OMB for review, as required by the Paperwork Reduction Act of 1995 (44 U.S.C. chapter 35, as amended).

This notice is soliciting comments from members of the public and affected agencies concerning the proposed collection of information to: (1) Evaluate whether the proposed collection is necessary for the proper performance of the functions of the agency, including whether the information will have practical utility; (2) Evaluate the accuracy of the agency's estimate of the burden of the proposed collection of information; (3) Enhance the quality, utility, and clarity of the information to be collected; and (4) Minimize the burden of the collection of information on those who are to respond; including the use of appropriate automated collection techniques or other forms of information technology, e.g. , permitting electronic submission of responses.

This Notice also lists the following information:

Title of Proposal: Land Registration, Purchaser's Revocation Rights, Sales Practices and Standards, and Formal Procedures and Rules of Practice.

OMB Control Number, if applicable: 2502-0243.

Description of the need for the information and proposed use: The Interstate Land Sales Full Disclosure Act protects consumers from fraud in the sale of land by requiring developers of non-exempt subdivisions to register with HUD and give purchasers a property report. The property report discloses facts about the land so the purchaser can make an informed lot purchase and tells them of their revocation rights. Developers are required to register subdivisions of 100 or more non-exempt lots with HUD.

Agency form numbers, if applicable: None.

Estimation of the total numbers of hours needed to prepare the information collection including number of respondents, frequency of response, and hours of response: There is a total of 19,579 annual burden hours estimated for a total of approximately 5,270 respondents. The frequency of response is on occasion, annually, and third-party disclosure totaling 117,958 total annual responses.

Status of the proposed information collection: Extension of a currently approved information collection.

The Housing Counseling Program is authorized by section 106 of the Housing and Urban Development Act of 1968 (12 U.S.C. 1701x). HUD enters into agreement with qualified public or private nonprofit organizations to provide housing counseling services to low- and moderate-income individuals and families nationwide. The services include providing information, advice and assistance to renters, first-time homebuyers, homeowners, and senior citizens in areas such as pre-purchase counseling, financial management, property maintenance and other forms of housing assistance to improve the clients' housing conditions and meet the responsibilities of tenancy and homeownership.

The purpose of the grant is to assist HUD-approved housing counseling agencies in providing housing counseling services to HUD-related and other clients. HUD funding of approved housing counseling agencies is not guaranteed and when funds are awarded, a HUD grant does not cover all expenses incurred by an agency to deliver housing counseling services. Counseling agencies must actively seek additional funds from other sources such as city, county, state and federal agencies and from private entities to ensure that they have sufficient operating funds. The availability of housing counseling program grants depends upon whether the U.S. Congress appropriates funds for this purpose, the amount of those funds, and the outcome of the competitions for award.

The 2001 grantees announced in Appendix A of this Notice were selected for funding through a competition announced in a Federal Register notice published on February 26, 2001 (66 FR 11841) for the housing counseling program. Applications submitted for each competition were scored and selected for funding on the basis of selection criteria contained in the Notice. HUD awarded $17.548 million in housing counseling grants to 369 housing counseling agencies nationwide: 340 local agencies, 11 intermediaries, and 18 State housing finance agencies.

Additionally, HUD distributed $734,500 in noncompetitive housing counseling grants. Specifically, $584,500 was awarded to the American Association of Retired Persons (AARP) to provide housing counseling services related to the Home Equity Conversion Program (HECM). HUD also awarded 7 housing counseling grants, totaling $150,000, to provide Native Americans with quality homeownership education and counseling services, and to build the capacity of organizations in Indian Country to provide housing counseling. Noncompetitive awards are announced in Appendix B of this notice.

In accordance with section 102(a)(4)(C) of the Department of Housing and Urban Development Reform Act of 1989 (103 Stat. 1987, 42 U.S.C. 3545), the Department is publishing the names, addresses, and award amounts as provided in Appendix A.

Pursuant to the Act, five Resource Advisory Committees have been formed for western Oregon BLM districts that contain Oregon & California (O&C) Grant Lands and Coos Bay Wagon Road lands. The Act establishes a six-year payment schedule to local counties in lieu of funds derived from the harvest of timber on federal lands, which have dropped dramatically over the past 10 years.

The Act creates a new mechanism for local community collaboration with federal land management activities in the selection of projects to be conducted on federal lands or that will benefit resources on federal lands using funds under Title II of the Act. The BLM Resource Advisory Committees consist of 15 local citizens (plus 6 alternates) representing a wide array of interests.

Title: Designation of Royalty Payment Responsibility.

OMB Control Number: 1010-0107.

Bureau Form Number: MMS-4425.

Abstract: The Department of the Interior (DOI) is responsible for matters relevant to mineral resource development on Federal and Indian lands and the Outer Continental Shelf (OCS). The Secretary of the Interior (Secretary) is responsible for managing the production of minerals from Federal and Indian lands and the OCS, collecting royalties from lessees who produce minerals, and distributing the funds collected in accordance with applicable laws. The Secretary also has an Indian trust responsibility to manage Indian lands and seek advice and information from Indian beneficiaries. MMS performs the royalty management functions and assists the Secretary in carrying out DOI's Indian trust responsibility.

The Federal Oil and Gas Royalty Simplification and Fairness Act of 1996 (RSFA), Public Law 104-185, as corrected by Public Law 104-200, established that owners of operating rights or lease record title (referred to as “lessees”) are responsible for making royalty and related payments on Federal oil and gas leases. It is common, however, for a payor rather than a lessee to make these payments. When a payor makes payments on behalf of a lessee, RSFA requires that the lessee designate the payor as its designee and notify MMS of this arrangement in writing. These RSFA requirements are codifed in 30 CFR 218.52.

MMS designed Form MMS-4425, Designation Form, to contain all the information necessary for lessees to comply with these RSFA requirements. We are proposing a minor revision to Form MMS-4425 to remove the field for revenue source code. This revision is necessary to make Form MMS-4425 compatible with other recently revised forms such as the Form MMS-2014, Report of Sales and Royalty Remittance. These revisions are the result of a major reengineering of MMS's financial and compliance processes and the procurement of a new computer system.

Submission of the information in this collection is necessary to comply with RSFA requirements to notify MMS in writing when a lessee wishes to designate a designee. Proprietary information that is submitted is protected, and there are no questions of a sensitive nature included in this information collection.

Frequency: On occasion.

Estimated Number and Description of Respondents: 1,600 oil and gas lessees.

Estimated Annual Reporting and Recordkeeping “Hour” Burden: 1,200 hours.

Estimated Annual Reporting and Recordkeeping “Non-hour Cost” Burden: We have identified no “non-hour cost” burdens.

Comments: The PRA (44 U.S.C. 3501, et seq. ) provides that 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. Before submitting an ICR to OMB, PRA section 3506(c)(2)(A) requires each agency “* * * to provide notice * * * and otherwise consult with members of the public and affected agencies concerning each proposed collection of information * * *.” Agencies must specifically solicit comments to: (a) Evaluate whether the proposed collection of information is necessary for the agency to perform its duties, including whether the information is useful; (b) evaluate the accuracy of the agency's estimate of the burden of the proposed collection of information; (c) enhance the quality, usefulness, and clarity of the information to be collected; and (d) minimize the burden on the respondents, including the use of automated collection techniques or other forms of information technology.

The PRA also requires agencies to estimate the total annual reporting “non-hour cost” burden to respondents or recordkeepers resulting from the collection of information. We have not identified non-hour cost burdens for this information collection. If you have costs to generate, maintain, and disclose this information, you should comment and provide your total capital and startup cost components or annual operation, maintenance, and purchase of service components. You should describe the methods you use to estimate major cost factors, including system and technology acquisition, expected useful life of capital equipment, discount rate(s), and the period over which you incur costs. Capital and startup costs include, among other items, computers and software you purchase to prepare for collecting information; monitoring, sampling, testing equipment; and record storage facilities. Generally, your estimates should not include equipment or services purchased: (i) Before October 1, 1995; (ii) to comply with requirements not associated with the information collection; (iii) for reasons other than to provide information or keep records for the Government; or (iv) as part of customary and usual business or private practices.

We will summarize written responses to this notice and address them in our ICR submission for OMB approval, including appropriate adjustments to the estimated burden. We will provide a copy of the ICR to you without charge upon request.

Public Comment Policy. We will also make copies of the comments available for public review, including names and addresses of respondents, during regular business hours at our offices in Lakewood, Colorado. Individual respondents may request that we withhold their home address from the public record, which we will honor to the extent allowable by law. There also may be circumstances in which we would withhold from the rulemaking record a respondent's identity, as allowable by law. If you request that we withhold your name and/or address, state this prominently at the beginning of your comment. However, we will not consider anonymous comments. We will make all submissions from organizations or businesses, and from individuals identifying themselves as representatives or officials of organizations or businesses, available for public inspection in their entirety.

MMS Information Collection Clearance Officer: Jo Ann Lauterbach, (202) 208-7744.

On November 19, 2001, Congress enacted the Aviation and Transportation Security Act (ATSA), Pub. L. 107-71. Upon enactment, section 113 of the ATSA imposed new constrictions on persons subject to regulation under Title 49 subtitle VII part A, United States Code, with respect to providing aviation training to aliens. Persons subject to regulation under Title 49 subtitle VII Part A, United States Code, include individual training providers, certificated carriers, and flight schools (hereinafter collectively referred to as “training providers”). Pursuant to section 113, training providers must provide the Attorney General with the alien's identification in such form as the Attorney General may require in order to initiate a security risk assessment by the Department of Justice. After notification, the Attorney General then has 45 days to inform the training provider that the alien should not be given the requested training because he or she presents a risk to aviation or national security. If the Attorney General does not indicate that the person is a risk within this 45-day review period, then the training provider may proceed with training. The ATSA, however, permits the Attorney General to interrupt training if he later determines that the alien poses a risk to aviation or national security. The Attorney General has delegated his authority under Section 113 to the Director of the Foreign Terrorist Tracking Task Force.

The Department recognizes that section 113 of the ATSA became immediately effective, and that training providers have been forced to suspend the training of aliens covered by the ATSA pending the implementation of the process for notification to the Attorney General. The Department plans to issue any necessary implementing regulations as soon as possible. However, because the suspension of training imposes a substantial economic burden on regulated training providers, the Department is granting provisional advance consent, effective immediately, for training providers to resume aviation training for certain categories of aliens who appear to pose a risk to aviation and national security which is sufficiently minimal that the Department would not deny them training. In addition, section 113 also permits the Under Secretary of Transportation for Security to specify other individuals for whom the Department should conduct security risk assessments. At this time, however, no other individuals have been specified. The Department plans to publish implementation procedures shortly to provide a means by which training providers may notify the Attorney General with respect to covered individuals seeking aviation instruction who are not eligible for advance consent in order to initiate the Department of Justice's 45-day review period.

The Department believes that the primary intent of Congress regarding the enactment of this statute was to prevent potentially dangerous aliens from being taught how to pilot aircraft with a maximum certificated takeoff weight of 12,500 pounds or more. Based on that standard, it appears that certain categories of aliens pose little such risk. For example, currently licensed pilots who seek recurrent training already know how to fly the aircraft for which they wish to maintain proficiency. Denying such retraining would appear to offer no benefit to aviation or national security. Indeed, the purpose behind recurrent training is to make flying safer for the public. The Department has identified several similar classes of aliens who appear not to pose the risk to aviation or national security contemplated by Congress in section 113 of the ATSA. The Department will revisit this provisional advance consent when it promulgates any necessary implementing regulations to determine whether these pilots should continue to be granted advance consent.

Accordingly, effective immediately and until further notice, the Department is granting a provisional advance consent for the training of the following three categories of aliens, based on an initial determination that they do not appear to pose a risk to aviation or national security:

(1) Foreign nationals who are currently employed by U.S. air carriers as pilots on aircraft with a maximum certificated takeoff weight of 12,500 pounds or more;

(2) Foreign nationals employed by foreign air carriers as pilots on aircraft with a maximum certificated takeoff weight of 12,500 pounds or more who are current and qualified as pilot in command, second in command, or flight engineer with respective certificates and ratings recognized by the United States; and

(3) Commercial, corporate, or military pilots of aircraft with a maximum certificated takeoff weight of 12,500 pounds or more who must receive familiarization training on a particular aircraft in order to transport it to the purchaser.

Section 113 of the ATSA applies to all aliens as defined in section 101(a)(3) of the Immigration and Nationality Act, but does not currently apply to citizens or nationals of the United States. Accordingly, training providers must make a determination as to whether or not a prospective trainee is an alien. If the prospective trainee establishes that he or she is a citizen or national of the United States, the restrictions of section 113 do not apply.

Training providers should require appropriate proof of citizenship or nationality from all trainees who claim to be citizens or nationals of the United States, before commencing aviation training on aircraft with a maximum certificated takeoff weight of 12,500 pounds or more. This requirement is necessary to prevent aliens from falsely claiming to be United States citizens or nationals in order to evade the Department's security risk assessment.

The Department believes that the following documents are sufficient to establish proof of citizenship or nationality:

(1) A valid, unexpired United States passport;

(2) An original birth certificate with raised sea documenting birth in the United States or one of its territories;

(3) An original U.S. naturalization certificate with raised seal, Form N-550 or Form N-570;

(4) An original certification of birth abroad, Form FS-545 or Form DS-1350; or

(5) An original certificate of U.S. citizenship, Form N-560 or Form N-561.

If a training provider has questions about the documents above or any other documentation presented by a person who claims to be a citizen or national of the United States, the training provider may seek further guidance from the Department or the Immigration and Naturalization Service.

After a training provider reasonably determines that a prospective alien trainee falls within one of the three advance consent categories, the training provider may proceed with training the alien immediately and does not have to submit any identifying information to the Department. The training provider, however, should retain records to document how the training provider made the determination that the alien was eligible for advance consent. Appropriate measures will be taken by the Department with respect to any alien who is determined to pose a risk to aviation or national security. Available civil and/or criminal penalties will be pursued with respect to any training provider who knowingly or negligently provides training to aliens not covered by this notice.

The Department of Labor seeks to collect data regarding the costs and usage of Workforce Investment Act (WIA) and Wagner Peyser services that do not require participant registration. Current reporting systems do not capture this information because self and informational services do not require registration and are not part of the performance accountability provisions of the respective statutes. This fact has complicated the budget process by limiting DOL's capacity to develop unit cost projections. In addition, DOL does not have complete information on WIA service design. The information that is developed will be used to inform budget decisions and the WIA reauthorization process.

The data will consist of information already collected by state and local workforce development staff for their own management purposes and data collected from a probability sample of persons using self-service facilities. The principal goal of the data collection is to develop a national estimate of the number of job seekers who use informational, self, or staff facilitated services that do not require registration in primary One-Stop programs and related costs.

The Department of Labor is particularly interested in comments which:

• Evaluate whether the proposed collection of information is necessary for the proper performance of the functions of the agency, including whether the information will have practical utility;

• Evaluate the accuracy of the agency's estimate of the burden of the proposed collection of information, including the validity of the methodology and assumptions used;

• Enhance the quality, utility, and clarify of the information to be collected; and

• Minimize the burden of the collection of information on those who are to respond, including through the use of appropriate automated, electronic, mechanical, or other technological collection techniques or other forms of information technology, e.g. , permitting electronic submissions of responses.

DOL is seeking Office of Management and Budget (OMB) approval to collect data on the costs and usage of Workforce Investment Act (WIA) and Wagner Peyser services that do not require registration. The data are necessary to inform budget decisions and for the WIA reauthorization process. The data will consist of information already collected by state and local workforce development staff for their own management purposes and data collected from a probability sample of persons using self-service facilities. The principal goal of the data collection is to develop a national estimate of the number of job seekers who use informational, self, or staff facilitated services that do not require registration in primary One-Stop programs.

Type of Review: New.

Agency: Employment and Training Administration.

Title: Estimation of ETA Non-Registrant Service Usage and Costs.

OMB Number: 1205-ONEW.

Affected Public: Individuals or households; State, Local or Tribal Government.

Total Respondents: 12,554.

Frequency: On occasion.

Total Responses: 12,554.

Average Time per Response: 12.37 hours for state survey; 2 minutes for participant survey.

Estimated Total Burden Hours: 1,085 for state and participant surveys; 2,760 local staff burden for participant survey.

Total Burden Hours for all surveys: 3,845.

Total Burden Cost (capital/startup): $0.

Total Burden Cost (operating/maintaining): $0.

Comments submitted in response to this comment request will be summarized and/or included in the request for Office of Management and Budget approval of the information collection request; they will also become a matter of public record.

Section 203(b)(1) of the Migrant and Seasonal Agricultural Worker Protection Act (MSPA), and § 500.135(b) of Regulations, 29 CFR part 500, provide that any person who owns or controls a facility or real property to be used for housing migrant agricultural workers must obtain and post on site, a certificate of occupancy from the State, local, or Federal agency which conducted the housing safety and health inspection. The WH-520 is a form used to gather information to determine whether or not the facility meets the applicable safety and health standards, and also serves as the certificate of occupancy.

The Department of Labor is particularly interested in comments which:

• Evaluate whether the proposed collection of information is necessary for the proper performance of the functions of the agency, including whether the information will have practical utility;

• Evaluate the accuracy of the agency's estimate of the burden of the proposed collection of information, including the validity of the methodology and assumptions used;

• Enhance the quality, utility and clarity of the information to be collected; and

• Minimize the burden of the collection of information on those who are to respond, including through the use of appropriate automated, electronic, mechanical, or other technological collection techniques or other forms of information technology, e.g. , permitting electronic submissions of responses.

The Department of Labor seeks approval for the extension of this information collection in order to inspect and certify a migrant housing facility as meeting applicable safety and health standards under the law.

Type of Review: Extension.

Agency: Employment Standards Administration.

Title: Housing Occupancy Certificate—Migrant and Seasonal Agricultural Worker Protection Act.

OMB Number: 1215-0158.

Agency Number: WH-520.

Affected Public: Individuals or households; Businesses or other for-profit; Farms.

Frequency: On occasion.

Total Respondents/Responses: 60.

Time per Response 3 minutes(Reporting): 1 minute (Recordkeeping and Posting).

Estimated Total Burden Hours: 4.

Total Burden Cost (capital/startup): $0.

Total Burden Cost (operating/maintenance): $0.

Comments submitted in response to this notice will be summarized and/or included in the request for Office of Management and Budget approval of the information collection request; they will also become a matter of public record.

The meeting will be open to the public up to the seating capacity of the room. The agenda for the meeting is as follows:

• Review of Previous Meeting

• OSDBU Update of Activities

• NAC Meeting Report

• Overview of NASA Ames

• Overview of Small Business Program

• Public Comment

• Panel Discussion and Review

• Committee Panel Reports

• Status of Open Committee Recommendations

• New Business

It is imperative that the meeting be held on these dates to accommodate the scheduling priorities of the key participants. Visitors will be requested to sign a visitor's register.

Title of Collection: The Cross Site Analysis of the Integrative Graduate Education and Research Traineeship (IGERT) Program.

OMB Control No.: 3145-0182.

EXPIRATION DATE OF APPROVAL: May 31, 2002.

Abstract: This document has been prepared to support the clearance of data collection instruments to be used in the evaluation of the Integrative Graduate Education and Research Traineeship (IGERT) Program. This site-based interview component is a part of a mixed method implementation and impact study and is comprised of on-site interviews of PIs, trainees, key faculty, and administrative personnel for all IGERT projects in their third year of funding (approximately 20 sites per year). It complements and verifies data from the previously cleared IGERT Distance Monitoring System (a Web-based survey completed annually by the project Principal Investigators, funded trainees, and non-funded associate students). While the Web-based survey provides prescribed and consistent data across all IGERT sites, site visits allow the collection of site-specific, in-depth information that answers questions raised by the Web-based collection and extends its scope. The two approaches inform and enrich each other to provide the clearest and most complete portrait possible of the evaluated program. Data are needed by NSF for program monitoring and to support program analysis, impact assessment, and evaluation activities.

Expected Respondents: Interview respondents at each IGERT project will include: the Principal Investigator, Co-Principal Investigators, Faculty associated with the project or advisors to trainees, Funded Trainees, Non-Funded Associates, and University Administrators.

Burden on the Public: Burden for respondents varies according to role, from 30 minutes to three hours. A total of 34 hours and 30 minutes interview time is projected for the estimated 44 respondents at each site. Over the average of 20 sites each year, this amounts to 880 respondents and a total of 690 hours. Burden to the public is limited because all respondents are limited to those associated with IGERT projects in their third year of implementation.

Title: National Science Foundation Proposal Evaluation Process.

OMB Control Number: 3145-0060.

The National Science Foundation (NSF) is an independent Federal agency created by the National Science Foundation Act of 1950, as amended (42 U.S.C. 1861-75). The Act states the purpose of the NSF is “to promote the progress of science; (and) to advance the national health, prosperity, and welfare” by supporting research and education in all fields of science and engineering.”

From those first days, NSF has had a unique place in the Federal Government: It is responsible for the overall health of science and engineering across all disciplines. In contrast, other Federal agencies support research focused on specific missions such as health or defense. The Foundation also is committed to ensuring the nation's supply of scientists, engineers, and science and engineering educators.

The Foundation fulfills this responsibility by initiating and supporting merit-selected research and education projects in all the scientific and engineering disciplines. It does this through grants and cooperative agreements to more than 2,000 colleges, universities, K-12 school systems, businesses, informal science organizations and other research institutions throughout the U.S. The Foundation accounts for about one-fourth of Federal support to academic institutions for basic research.

The Foundation relies heavily on the advice and assistance of external advisory committees, ad-hoc proposal reviewers, and to other experts to ensure that the Foundation is able to reach fair and knowledgeable judgments. These scientists and educators come from colleges and universities, nonprofit research and education organizations, industry, and other Government agencies.

In making its decisions on proposals the counsel of these merit reviewers has proven invaluable to the Foundation both in the identification of meritorious projects and in providing sound basis for project restructuring.

Review of proposals may involve large panel sessions, small groups, or use of a mail-review system. Proposals are reviewed carefully by scientists or engineers who are expert in the particular field represented by the proposal. About 50% are reviewed exclusively by panels of reviewers who gather, usually in Arlington, VA, to discuss their advice as well as to deliver it. About 35% are reviewed first by mail reviewers expert in the particular field, then by panels, usually of persons with more diverse expertise, who help the NSF decide among proposals from multiple fields or sub-fields. Finally, about 15% are reviewed exclusively by mail.

The information collected is used to support grant programs of the Foundation. The information collected on the proposal evaluation forms is used by the Foundation to determine the following criteria when awarding or declining proposals submitted to the Agency: (1) What is the intellectual merit of the proposed activity? (2) What are the broader impacts of the proposed activity?

The information collected on reviewer background questionnaires is used by managers to maintain an automated database of reviewers for the many disciplines represented by the proposals submitted to the Foundation. Information collected on gender, race, ethnicity is used in meeting NSF needs for data to permit response to Congressional and other queries into equity issues. These data are also used in the design, implementation, and monitoring of NSF efforts to increase the participation of various groups in science, engineering, and education.

When a decision has been made (whether an award or a declination), verbatim copies of reviews, excluding the names of the reviewers, and summaries of review panel deliberations, if any, are provided to the PI. Proposers also may request and obtain any other releasable material in NSF's file on their proposal. Everything in the file except information that directly identifies either reviewers or other pending or declined proposals is usually releasable to the proposer.

While listings of panelists' names are released, the names of individual reviewers, associated with individual proposals, are not released to anyone.

Because the Foundation is committed to monitoring and identifying any real or apparent inequities based on gender, race, ethnicity, or disability of the proposed principal investigator(s)/project director(s) or the co-principal investigator(s)/co-project director(s), the Foundation also collects information regarding race, ethnicity, disability, and gender. This information is also protected by the Privacy Act.

The Foundation estimates that anywhere from one hour to twenty hours may be required to review a proposal. It is estimated that approximately five hours are required to review an average proposal. Each proposal receives an average of 8.5 reviews.

The Alaron Corporation of Wampum, Pennsylvania holds a license issued by the U.S. Nuclear Regulatory Commission (NRC) for performing decontamination of equipment contaminated with radioactive material. Alaron has requested authority to add a system for the treatment of wet wastes by installing a system which includes a concentrate dryer, ultra-filtration, reverse-osmosis, demineralizers and steam generator on its site in Wampum.

Alaron estimates that approximately 214 curies of radioactive materials would be processed per year. Environmental radiation safety concerns include exposure due to airborne releases. To evaluate airborne releases, the licensee utilized a computer code (COMPLY, an EPA computer code for calculating the dose to individuals due to airborne releases) to assess dose from radionuclide emissions. The code assumed that an activity of 740 millicuries would be released in effluents to the air and projected a effective dose equivalent of 0.03 millirem/year to an individual at the nearest site boundary.

NRC has reviewed the assumptions used in the above described codes and concurs with the reported results. The maximum annual dose of 0.03 millirem is well below the regulatory limit of 100 millirem per year.

Copies of the EA and FONSI as well as supporting documentation are available for review at the NRC offices located at 475 Allendale Road, King of Prussia, Pennsylvania 19406, telephone number (610) 337-5000, during normal business hours.

The Alaron Corporation of Wampum, Pennsylvania holds a license issued by the U.S. Nuclear Regulatory Commission (NRC) for performing decontamination of equipment contaminated with radioactive material. Alaron uses a variety of techniques to perform the decontamination. In a letter dated May 31, 2001, Alaron requested an amendment to their license to authorize a wet waste processing system to dry high-solids wet wastes and aqueous liquid wastes in their Wampum facility. The system will be supplied by NUKEM Nuclear Technologies and includes a concentrate dryer, ultra-filtration units, reverse-osmosis units, demineralizers, steam generator and holding tanks. The purpose of this Environmental Assessment is to determine whether or not the proposed action could contribute to significant impacts on the human environment.

The only credible alternative is to not allow Alaron to install and use the treatment system. Relocation of the unit to another part of the site would not alter the environmental impact of the operation of the unit. To allow the use of some components of the system and not others could actually result in an increase in the amount of activity released to the environment.

Alaron is located on a 24 acre site in the Point Industrial Park, Wampum, Pennsylvania. Building F1 is a 67,800 ft 2 steel frame and steel wall building with a flat synthetic membrane type roof. The proposed wet waste processing system would be located inside a curbed area at the east end of the F1 Annex. The F1 Annex is located on the east side of the F1 Building and is a steel frame, steel walled building 32 feet wide and 88 feet long. The curbed area in the F1 Annex is capable of holding all of the contaminated liquid in the wet waste system. The NUKEM system consists of a number of water treatment components, including a concentrate dryer (CD), an ultra-filtration (UF) unit, a reverse osmosis (RO) unit, two demineralizers, and a steam generator. Wet waste will arrive by truck and will be transferred to one of two 1400 gallon sludge tanks inside the curbed area of the F1 Annex using a pneumatic pump through a double containment transfer hose.

Alaron's License No. 37-20826-01 was last renewed in its entirety on December 3, 1998. As part of that renewal, NRC issued an Environmental Assessment (NUREG/CR-5549) and published a Finding of No Significant Impact in the Federal Register on December 2, 1998. The Environmental Assessment found that no atmospheric emissions containing radioactive contaminants were expected to be released from the operation as then licensed. This was based on the fact that potentially contaminated air within work areas is cycled through HEPA filters and exhausted back into the building. Alaron recognized, though, that fugitive emissions, through doors, vents, etc. exist and a conservative estimate of an annual dose to the nearest residence was calculated to be 0.26 millirem. 10 CFR 20.1301 requires that each licensee conduct operations so that the total effective dose equivalent to individual members of the public from the licensed operation does not exceed 0.1 rem (100 millirem) in a year.

The installation of this waste treatment system would add an airborne release point at the Alaron facility. Steam from the steam generator will be vented through an exhaust stack on the roof of the F1 Building. Most of the radioactivity in the wet waste to be processed will be removed by the various treatment methods in the system and will be disposed of as solid waste. After being cleaned by passing through the system, the cleaned or polished water feeds the steam generator. Steam from the steam generator is exhausted through the stack.

Alaron estimates that the wet waste processing system will process liquid, sludge and/or resin waste whose isotopic distribution is typical of waste currently being disposed from nuclear power facilities. Based on the estimated waste throughput, approximately 214 curies of radioactive material will be processed per year. Assuming that all of the H-3 activity will become airborne, that the polished water feed to the steam generator contains other isotopes at 10 CFR Part 20 effluent limits, and that all of the radioactivity in the feed is released, the total activity emitted per year would be about 740 millicuries. The licensee performed dose calculations using the computer code COMPLY (an EPA computer code for calculating the dose to individuals due to airborne releases) which projects an effective dose equivalent of 0.03 millirem/year to an individual at the nearest site boundary as a result of the estimated release. NRC has performed a dose assessment of the proposal and agrees with the basic assumptions and results of the licensee's analysis.

With regard to direct radiation exposure, the licensee plans to conduct cleaning and back flush evolutions that will assure that accumulation of radioactive material on filter media will not result in high radiation levels around the unit. In addition, there will be shielding in place to avoid creation of high radiation levels. The maximum radiation levels is expected to be 50 millirem per hour one foot from the Concentrate Dryer, i.e. within the restricted area. Radiation levels at the closest unrestricted area, including the contribution from existing operations, will be about 10 microrem per hour.

In view of the fact that the additional dose of 0.03 millirem/year to an individual at the nearest site boundary as a result of the proposed amendment is a small fraction of the dose attributed to fugitive emissions to an individual at the nearest residence as a result of existing operations, the staff concludes that the proposed action will have a negligible impact on the environment.