Titles: Forms FNS-735, FNS Regional Office-School Food Authority Agreement and FNS-736, State Agency-School Food Authority Agreement.

OMB Number: New.

Expiration Date: Not yet assigned.

Type of Request: New.

Abstract: The Forms FNS-735, FNS Regional Office-School Food Authority Agreement and FNS-736, State Agency-School Food Authority Agreement are used to set out the requirements for administering the Child Nutrition Programs and the Food Distribution Program (Child Nutrition Program related portions only) of the U.S. Department of Agriculture (USDA).

On October 31, 1998, President Clinton signed the Child Nutrition Reauthorization Act of 1998 (Pub. L. 105-336). Section 102(d) amended section 9(i) of the NSLA (42 U.S.C. 1758(i)) by establishing two requirements with respect to school food authorities (SFA) which administer any combination of the Child Nutrition Programs under the same State administering agency (SA). First the SA must use a single State/local agreement for all programs operated by the SFA, including an alternate SFA under that SA. This also means that multiple programs operated under an alternate SA must be combined into a single agreement. A SA must use a common reimbursement form to claim meals under all of the programs. Previously, single agreements and common claim forms were permitted at SA option for SFAs administering multiple Child Nutrition Programs under a single SA.

Estimate of Burden: Public reporting burden for this collection of information is estimated to average .25 hours per response.

Respondents: The respondents are State agencies, FNS Regional Offices, and School Food Authorities participating in the National School Lunch Program (NSLP), School Breakfast Program (SBP), Summer Food Service Program (SFSP), Child and Adult Care Food Program (CACFP), School Milk Program (SMP), and Food Distribution Program (FDP—child nutrition program related portions only).

Estimated Number of Respondents:

Estimated Number of Responses per Respondent:

Estimated Total Annual Burden on Respondents:

The proposed site for the New Magdalena Ridge Observatory (MRO) facilities is within Langmuir Research Site, a 31,000-acre area set aside by Congress in 1980, under Public Law 96-550, for the purpose of encouraging scientific research into atmospheric processes and astronomical phenomena. New Mexico Institute of Mining and Technology (NMT) is part of a consortium of universities along with the U.S. Navy, Naval Research Laboratory (NRL) that would develop this facility. The observatory would feature both a conventional telescope and an interferometer array of telescopes that function together to provide more resolution than that which is available from a single telescope. This innovative technology has been pioneered by NRL at the Navy Prototype Optical Inteferometer (NPOI) near Flagstaff, Arizona. Experience from developing NPOI would be applied to this proposed facility with further refinements that would improve capabilities for high-resolution observations. The observatory's primary purpose would be for education and optical and astronomical research by NMT and the consortium members. A secondary purpose would be to support passive observing techniques for identifying satellites and to track missiles during tests at White Sands Missile Range.

The primary purpose of the MRO would be education and research by NMT and other consortium members. The facility would provide access to state-of-the-art telescopes, cameras, spectrometers, and associated equipment. There is an acute need for high-tech education in New Mexico, where the economy is closely tied to science and engineering. The MRO would serve the academic research community by providing telescopes for research and development of research techniques. This is important and timely, and the need is great due to the ongoing closing of several research telescopes at other observatories, which has handicapped the research community. The observatory would also provide public outreach, programs for K-12 students, courses for K-12 teachers, research experiences for undergraduates, and support of research by graduate students.

A secondary purpose would be to support the defense community. Using the interferometer array, passive observing techniques for identifying satellites could be developed. This would serve a national need to know how well satellites are performing and to improve their performance if they malfunction. A stand-alone, single telescope would be able to track missiles during tests sat the White Sands Missile Range. Also, this telescope could be used as a test bed for new instruments and sensors and could be used to develop new surveillance technologies.

To amend the existing Special Use Permit to the New Mexico Institute of Mining and Technology (NMT) to allow NMT to construct and operate a new observatory, called the Magdalena Ridge Observatory, on the ridge of the Magdalena Mountains. The new facilities would be situated on the ridge of the Magdalena Mountains between the main Langmuir Laboratory Principle Research Area and South Baldy Peak. Physical development would have two main parts: (1) the scientific equipment consisting of an interferometer array and associated infrastructure, and a single stand-alone telescope; and, (2) educational and research support facilities. An area of about 80 acres would be delineated as the primary science area where only the interferometer array and main telescope and associated support facilities would be located. The educational and supporting facilities would be located outside this area to reduce wind turbulence that can interfere with viewing objects in space. Fencing would be erected around some facilities, including the array, to prevent damage to the scientific equipment, for example, by livestock or recreationists. About 52,000 square feet (SF) of new enclosed facilities would be constructed, and about 85,000 SF of compacted gravel parking areas and roadway. A trench for new utilities lines (about one mile in length and five feet wide) would be dug. Excavations for building foundations and pits for water storage tanks and septic fields may involve blasting. Construction activities could directly disturb about six to eight acres and a larger area (about 10 to 12 acres) may be affected from operating construction equipment. Construction would take place over four to five years.

There is an acute need for high-tech education in New Mexico, where the economy is closely tied to science and engineering. The MRO would serve the academic research community by providing telescopes for research and development of research techniques. This is important and timely, and the need is great due to the ongoing closing of several research telescopes at other observatories, which has handicapped the research community.

The purpose and need of the Magdalana Ridge Observatory (MRO) are: (1) Education and research by NMT and other consortium members, (2) provide access to state-of-the-art telescopes, cameras, spectrometers, and associated equipment, (3) provide public outreach programs for K-12 students, courses for K-12 teachers, research experiences for undergraduates, and support of research by graduate students, (4) support to the defense community by using the interferometer array, passive observing techniques for identifying satellites, (5) assist in the need to know how well satellites are performing and to improve their performance if they malfunction, (6) support of tests at the white Sands Missile Range and a test bed for new instruments and sensors that could be used to develop new surveillance technologies.

Overall guidance for land management activities in the project area is provided by the Cibola National Forest Plan (U.S. Department of Agriculture, 1985). The proposed area is also covered by an existing Special Use Permit, Number 70, for the Langmuir Laboratory and the Operation and Maintenance Plan of May 2002 for the Langmuir Laboratory.

No Action Alternative— This alternative will serve as the baseline for the project and display the existing resource conditions. Under this alternative no modifications would be made to the Special Use Permit to the New Mexico Institute of Mining and Technology (NMT) nor would there be construction to operate a new observatory and its associated facilities.

Full Build Out Alternative.— This would involve all sixteen telescopes at one time instead of seven. This would be similar to the proposed, with the exception of the number of telescopes being installed at one time.

Optical Laser Techniques Alternative— This alternative would involve the use of adaptive optical techniques utilizing laser guide stars. A laser system of about 100 watts of power would be included with the scientific facilities identified in the proposed action.

24/24 Alternative —This would involve adding two additional movable telescopes with mirrors of approximately 2.4 meters, linked to the interferometer array located south of the proposed single telescope site.

the USDA Forest Service, Cibola National Forest will be the lead agency for this proposed project. The U.S. Navy, Naval Research Laboratory (NRL) is a cooperating agency. New Mexico Institute of Mining and Technology (NMT) is also a cooperating agency and part of a consortium of universities cooperating on this project.

Cibola National Forest Supervisor, 2113 Osuna Road NE., Suite A, Albuquerque, NM 87113-1001.

The USDA Forest Service must decide whether or not to amend the existing Special Use Permit that currently allows NMT to operate the Langmuir Laboratory for Atmospheric Research, to include the proposed observatory and its associated facilities.

A Public Involvement and Communication Plan (PIC) will be developed. It will focus on methods to inform the public on the proposal and to solicit public comments to help identify issues, concerns and opportunities associated with the Proposed Action. A prescoping letter will be sent out the week of October 1, 2002, with a two week response period to assist the forest in focusing on those audiences who are interested in the proposed activity. Once responses have been returned from the pre-scoping letter, the PIC plan will be implemented. No specific meeting dates and locations have been identified at this time. The number, location and type of public involvement meetings to be held will be identified after comments have been returned from the pre-scoping letter.

• Potential effects on Threatened and Endangered Species and habitat.

• Potential effects on visual quality from off-site locations on viewscape, including from adjacent ridges that may be used and/or have special value for Native American tribes.

• Potential effects of increased traffic on Water Canyon Road, and impact on private property inholdings and easements.

• Potential effects on recreation (such as cross country skiing and hunting) from new facilities and fenced areas.

• Potential effects on the Forest's ability to reduce fire risks within the Forest boundary and prevent catastrophic wildfire from increased human activity.

• Potential effects of developing and using a new water supply in an area where water for grazing operations is already stressed.

• Potential effects of slight reduction in area available for grazing, recreation, and other multiple uses that USFS determines to be incompatible with the primary use of the site for scientific purposes.

Solid Waste, Air Quality, and Water Use.

This Notice of Intent initiates the scoping process which guides the development of the environmental impact statement.

Early Notice of Importance of Public Participation in Subsequent Environmental Review: A draft environmental impact statement will be prepared for comment. The comment period on the draft environmental impact statement will be 45 days from the date the Environmental Protection Agency publishes the notice of availability in the Federal Register .

The Forest Service believes, at this early stage, it is important to give reviewers notice of several court rulings related to public participation in the environmental review process. First, reviewers of draft environmental impact statements must structure their participation in the environmental review of the proposal so that it is meaningful and alerts an agency to the reviewer's position and contentions. Vermont Yankee Nuclear Power Corp. v. NRDC, 435 U.S. 519, 553 (1987). Also, environmental objections that could be raised at the draft environmental impact statement stage but that are not raised could be raised at the draft environmental impact statement stage but that are not raised until after completion of the final environmental impact statement may be waived or dismissed by the courts. City of Angoon v. Hodel, 803 F.2d 1016, 1022 (9th Cir. 1986) and Wisconsin Heritages, Inc. v. Harris, 490 F. Supp. 1334, 1338 (E.D. Wis. 1980). Because of these court rulings, it is very important that those interested in this proposed action participate by the close of the November 29, 2002, comment period so that substantive comments and objections are made available to the Forest Service at a time when it can meaningfully consider them and respond to them in the final environmental impact statement.

To assist the Forest Service in identifying and considering issues and concerns on the proposed action, comments on the draft environmental impact statement should be as specific as possible. It is also helpful if comments refer to specific pages or chapters of the draft statement. Comments may also address the adequacy of the draft environmental impact statement or the merits of the alternatives formulated and discussed in the statement. Reviewers may wish to refer to the Council on Environmental Quality Regulations for implementing the procedural provisions of the National Environmental Policy Act at 40 CFR 1503.3 in addressing these points.

Comments received, including the names and addresses of those who comment, will be considered part of the public record on this proposal and will be available for public inspection.

Noxious weeds and invasive exotic plants are a serious biodiversity issue of great significance to human and natural resource conditions on the KNF. Increasing human population and activity contributes to the rapid spread of weeds. There are about 2,000 exotic and noxious weed species already established in the United States, with more entering the country every year as trade and travel between continents increases. Millions of acres of public lands in the West are rapidly undergoing the greatest degradation due to the spread of invasive non-native plants. Estimates indicate invasive plants are increasing at about 4,600 acres per day on Federal lands alone, and spreading at a rate of 14% per year (Asher and Mullahey, Weed Science Society of America Congressional Briefing, 1997). Within the last 20 years in California, studies show that yellow starthistle alone has increased from 1 million acres to more than 20 million-about 22 percent of the State's land base (Joe DiTomasso, Department of Weed Science, University of California, Davis, personal communication). Current inventories indicate that weeds are spreading at an increasing rate on Forest Service lands within the Pacific Southwest Region (Region 5 Strategy).

According to statistics compiled by the Integrated Pest Control Branch of the California Department of Food and Agriculture Plant Health and Pest Prevention Services (1998 Annual Report), 93 percent of the acres infested with A-rated noxious weeds in the State are located in the northeastern part of the State, including Siskiyou County. B- and C-rated pests occur in greater numbers and their density and frequency varies according to individual site locations. These species are generally widespread in the State of California and in Siskiyou County, and eradication is not an achievable goal on a broad scale. On the KNF, the numbers of exotic invasive plant species and areas infested are relatively small compared to other parts of the west. The KNF still has an opportunity to prevent extensive weed infestation and spread if aggressive, consistent treatment is employed.

The objectives of the KNF Noxious and Invasive Plant Control Project are to:

• Protect the ecosystem function and biodiversity of the KNF by preventing the continued spread of aggressive, non-native plant species.

• Prevent the spread of established non-native noxious and invasive plants into uninfested or lightly infested area. This is a strategy of containing the leading edge.

• Eradicate new invaders (non-native noxious and invasive plant species not previously reported in the area) before they become established.

• Eradicate or control known and potential non-native noxious and invasive plant infestations in the following areas that are considered infestation pathways (roads, trails, streams, intensively burned areas) for the establishment and movement of these plants on the KNF.

The U.S. Department of Agriculture (USDA) Forest Service, KNF, proposes to treat/control prioritized noxious weeds that are spread geographically over 27,000 acres on known and suspected infestation sites Forest-wide by a variety of treatment methods. Actual treatment would be on 2,700 acres per year or less. The word “control” refers to eradication (elimination) or reduction for some weed populations, and slowing the rate of spread for others. An Integrated Pest Management approach will be used, which employs a combination of control methods including: physical control ( e.g. hand-pulling, digging, clipping, mowing, tilling, and burning); cultural control ( e.g., seeding and cultivation); biological control ( e.g., use of parasites and pathogens); and chemical control ( e.g., use of herbicides). No aerial spraying of herbicides will occur.

Margaret Boland, Forest Supervisor, KNF, 1312 Fairlane Road, Yreka, California 96097 is the Responsible Official.

The decision is what actions, if any, should be taken to control non-native noxious and invasive plants on the KNF; where treatments should be applied, what type of treatments should be used, and what resource protection measures and operating procedures will be applied.

In April 2002, this project was included in the KNF's Spring 2002 Schedule of Proposed Actions (SOPA), which was posted on the KNF's internet website and mailed to the SOPA mailing list. In October 2002, a scoping letter of the proposed project will be sent to potentially affected individuals and anyone who expresses an interest in this proposal. This notice will invite public comment. Comments received will be included in the documentation for the EIS. The public is encouraged to take part in the process and to with the Forest Service officials at any time during the analysis and prior to the decision. The Forest Service will be seeking information, comments and assistance from Federal, State, and local agencies and other individuals or organizations who may be interested in, or affected by, the proposed administrative study.

While public participation in this analysis is welcome at any time, comments received within 45 days of the publication of this notice will be especially useful in the preparation of the Draft EIS. Information will be used in preparation of the draft and final EIS. The scoping will include identifying: potential issues, significant issues to be analyzed in depth, alternatives to the proposed action, and potential environmental effects of the proposed and alternatives.

This notice of intent initiatives the scoping process, which guides the development of the environmental impact statement.

A draft environmental impact statement will be prepared for comment. The comment period on the draft environmental impact statement will be 45-days from the date the Environmental Protection Agency publishes the notice of availability in the Federal Register .

The Forest Service believes, at this early stage, it is important to give reviewers notice of several court rulings related to public participation in the environmental review process. First, reviewers of Draft EISs must structure their participation in the environmental review of the proposed so that it is meaningful and alerts an agency to the reviewer's position and contentions. Vermont Yankee Nuclear Power Corp v. NRDC, 435 U.S. 519, 533, (1978). Also, environmental objections that could be raised at the Draft EIS stage but that are not raised until after completion of the Final EIS may be waived or dismissed by the courts. City of Angoon v. Hodel, 803 F.2d 1016, 1022 (9th Cir. 1986) and Wisconsin Heritages, Inc. v. Harris, 490 F. Supp. 1334, 1338 (E.D. Wis. 1980). Because of these court rulings, it is very important that those interested in this proposed action participate by the close of the 45-day comment period so that substantive comments and objections are made available to the Forest Service at a time when it can meaningfully consider them and respond to them in the Final EIS.

To assist the Forest Service in identifying and considering issues and concerns on the proposed action, comments on the Draft EIS should be as specific as possible. It is also helpful if comments refer to specific pages or chapters of the draft statement. Comments may also address the adequacy of the Draft EIS or the merits of the alternatives formulated and discussed in the statement. Reviewers may wish to refer to the Council on Environmental Quality Regulations for implementing the procedural provisions of the National Environmental Policy Act at 40 CFR 1503.3 in addressing these points.

Comments received, including the names and addresses of these who comment, will be considered part of the public record on this proposal and will be available for public inspection.

The meeting is open to the public. Council discussion is limited to Forest Service/BLM staff and Council Members. Lunch will be on your own. A public input session will be at 2:45 p.m. for fifteen minutes. The meeting is expected to adjourn around 4 p.m.

A public input period will begin at 11:45 a.m. The meeting is expected to adjourn a few minutes after 12 noon.

The meeting agenda includes reviewing project proposals for fiscal year 2003. The public forum begins at 1 p.m.

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) regulations are to the regulations codified at 19 CFR part 351 (April 2002).

We preliminarily determine that imports of urea ammonium nitrate solutions (UANS) from Ukraine are being, or are likely to be sold, in the United States at less than fair value (LTFV), as provided in section 733 of the Act. The estimated margins of sales at LTFV are shown in the “Suspension of Liquidation” section of this notice.

On May 9, 2002, the Department initiated antidumping duty investigations to determine whether imports of UANS from Lithuania, Belarus, the Russian Federation, and Ukraine are being, or are likely to be, sold in the United States at LTFV. See Initiation of Antidumping Investigations: Urea Ammonium Nitrate Solutions from Belarus, Lithuania, the Russian Federation, and Ukraine , 67 FR 35492 (May 20, 2002) ( Initiation Notice ). 1

On June 4, 2002, the International Trade Commission (ITC) preliminarily determined that there is a reasonable indication that an industry in the United States is materially injured or threatened with material injury by reason of imports of UANS from Belarus, the Russian Federation and Ukraine. See Urea Ammonium Nitrate Solution from Belarus, Lithuania, the Russian Federation and Ukraine , 67 FR 39439 (June 7, 2002).

During May 2002, the Department provided participating parties with an opportunity to comment on scope and the product characteristics of subject merchandise. No parties submitted comments.

On May 22, 2002, the Department issued its antidumping questionnaire 2 to JSC Stirol (Stirol), JSC Azot Cherkassy (Cherkassy), and to the Embassy of Ukraine in Washington, DC requesting that they forward it to any other potential respondents. The Department received no responses to the questionnaire.

The period of investigation (POI) is October 1, 2001, through March 31, 2002. This period corresponds to the two most recent fiscal quarters prior to the filing of the petition ( i.e ., April 2002). See 19 CFR 351.204(b)(1).

For purposes of these investigations, the product covered is all mixtures of urea and ammonium nitrate in aqueous or ammoniacal solution, regardless of nitrogen content by weight, and regardless of the presence of additives, such as corrosion inhibitors. The merchandise subject to these investigations is classified in the Harmonized Tariff Schedule of the United States (HTSUS) under item number 3102.80.00.00. Although the HTSUS item number is provided for convenience and U.S. Customs Service (U.S. Customs) purposes, the written description of the merchandise under investigation is dispositive.

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 (the Department) regulations are to the regulations codified at 19 CFR part 351 (April 2002).

We preliminarily determine that imports of urea ammonium nitrate solutions (UANS) from Belarus are being sold, or are likely to be sold, in the United States at less than fair value (LTFV), as provided in section 733 of the Act. The estimated margins of sales at LTFV are shown in the “Suspension of Liquidation” section of this notice.

On May 9, 2002, the Department initiated antidumping duty investigations to determine whether imports of UANS from Lithuania, Belarus, the Russian Federation, and Ukraine are being, or are likely to be, sold in the United States at LTFV. See Initiation of Antidumping Investigations: Urea Ammonium Nitrate Solutions from Belarus, Lithuania, the Russian Federation, and Ukraine , 67 FR 35492 (May 20, 2002) ( Initiation Notice ). 1

On June 4, 2002, the International Trade Commission (ITC) preliminarily determined that there is a reasonable indication that an industry in the United States is materially injured or threatened with material injury by reason of imports of UANS from Belarus, the Russian Federation and Ukraine. See Urea Ammonium Nitrate Solution from Belarus, Lithuania, the Russian Federation and Ukraine , 67 FR 39439 (June 7, 2002).

During May 2002, the Department provided participating parties with an opportunity to comment on scope and the product characteristics of subject merchandise. No parties submitted comments.

On May 22, 2002, the Department issued its antidumping questionnaire 2 to the Embassy of Belarus in Washington D.C., and to the company identified in the petition, Grodno Production Republican Enterprise “GPO Azot” (Grodno). The Department requested that the Embassy of Belarus send the questionnaire to all companies that manufactured and exported UANS to the United States, as well as all manufacturers that produced UANS for companies engaged in exporting subject merchandise to the United States, and all companies that exported UANS to the United States, during the period of investigation (POI). Only Grodno responded to the Department's questionnaire; the Department received timely responses on June 12, 2002 for the section A response, and July 2, 2002 for the section C and D responses. During July and August 2002, the Department issued and Grodno responded to three supplemental questionnaires.

The POI is October 1, 2001, through March 31, 2002. This period corresponds to the two most recent fiscal quarters prior to the month of the filing of the petition ( i.e ., April, 2002). See 19 CFR 351.204(b)(1).

For purposes of this investigation, the product covered is all mixtures of urea and ammonium nitrate in aqueous or ammoniacal solution, regardless of nitrogen content by weight, and regardless of the presence of additives, such as corrosion inhibitors. The merchandise subject to this investigation is classified in the Harmonized Tariff Schedule of the United States (HTSUS) under item number 3102.80.00.00. Although the HTSUS item number is provided for convenience and U.S. Customs Service (U.S. Customs) purposes, the written description of the merchandise under investigation is dispositive.

Chapter 19 of the North American Free-Trade Agreement (“Agreement”) establishes a mechanism to replace domestic judicial review of final determinations in antidumping and countervailing duty cases involving imports from a NAFTA country with review by independent binational panels. When a Request for Panel Review is filed, a panel is established to act in place of national courts to review expeditiously the final determination to determine whether it conforms with the antidumping or countervailing duty law of the country that made the determination.

Under Article 1904 of the Agreement, which came into force on January 1, 1994, the Government of the United States , the Government of Canada and the Government of Mexico established Rules of Procedure for Article 1904 Binational Panel Reviews (“Rules”). These Rules were published in the Federal Register on February 23, 1994 (59 FR 8686).

A first Request for Panel Review was filed with the United States Section of the NAFTA Secretariat, pursuant to Article 1904 of the Agreement, on September 19, 2002, requesting panel review of the final determination described above.

The Rules provide that:

(a) A Party or interested person may challenge the final determination in whole or in part by filing a Complaint in accordance with Rule 39 within 30 days after the filing of the first Request for Panel Review (the deadline for filing a Complaint is October 21, 2002);

(b) A Party, investigating authority or interested person that does not file a Complaint but that intends to appear in support of any reviewable portion of the final determination may participate in the panel review by filing a Notice of Appearance in accordance with Rule 40 within 45 days after the filing of the first Request for Panel Review (the deadline for filing a Notice of Appearance is November 4, 2002); and

(c) The panel review shall be limited to the allegations of error of fact or law, including the jurisdiction of the investigating authority, that are set out in the Complaints filed in the panel review and the procedural and substantive defenses raised in the panel review.

The draft Code of Conduct was released for public comment via Federal Register notice dated August 23, 2002 (67 FR 54644), with a 30-day comment period. NMFS is extending the comment period in response to numerous requests from the public indicating that a 30-day comment period does not allow sufficient time for stakeholders to provide their input into the preparation of the final document. The previous Federal Register notice provided a tentative time frame for the production of a Code of Conduct. To accommodate the longer comment period, the time frame for production of a final Code of Conduct has been revised as provided here.

August 23, 2002: Release draft Code of Conduct for public comment via posting of the document on the NMFS Web site ( www.nmfs.noaa.gov/aquaculture.htm ). The document will also be provided in hard copy upon request ( see FOR FURTHER INFORMATION CONTACT ).

October 31, 2002: Public comment period on draft Code of Conduct ends.December 2002: Release final Code of Conduct via a Federal Register notice of availability and posting on the NMFS Web site ( www.nmfs.noaa.gov/aquaculture.htm ). The document will also be provided in hard copy upon request ( see FOR FURTHER INFORMATION CONTACT ).

This document gives notice of revisions in per diem rates prescribed by the Per Diem Travel and Transportation Allowance Committee for non-foreign areas outside the continental United States. It supersedes Civilian Personnel Per Diem Bulletin Number 227. Distribution of Civilian Personnel Per Diem Bulletins by mail was discontinued. Per Diem Bulletins published periodically in the Federal Register now constitute the only notification of revisions in per diem rates to agencies and establishments outside the Department of Defense. For more information or questions about per diem rates, please contact your local travel office. The text of the Bulletin follows:

Title 10, USC 4346 provides requirements for admission of candidates to the US Military Academy. The US Military Academy USMA strives to motivate outstanding potential candidates to apply for admission to USMA. Once candidates are found, USMA collects information necessary to nurture them through successful completion of the application process.

Title 10, U.S.C. 4346 provides requirements for admission of candidates to the U.S. Military Academy. The U.S. Military Academy USMA strives to motivate outstanding potential candidates to apply for admission to USMA. Once candidates are found, USMA collects information necessary to nurture them through successful completion of the application process.

Title 10, USC 4346 provides requirements for admission of candidates to the US Military Academy. The US Military Academy USMA strives to motivate outstanding potential candidates to apply for admission to USMA. Once candidates are found, USMA collects information necessary to nurture them through successful completion of the application process.

Proposed Agenda: Fall Annual Meeting of the Board of Visitors. Review of the Academic, Military, Moral, Ethical, and the Physical Programs at the USMA. Approval of the 2002 Annual Report to the President. All proceedings are open.

The resolution authorized a study to determine the feasibility of constructing approximately 55 miles of hurricane protection levee from Larose, Louisiana to the western Davis Pond guide levee located east of Boutte, Louisiana. The proposed levee alignment would start at the Gulf Intracoastal Waterway in Lafourche Parish and proceed north parceling the east side of Bayou Lafourche to U.S. Highway 90 south of Raceland, Louisiana. The alignment would proceed northeast paralleling the south side of U.S. Highway 90 to Bayou Des Allemands. A water control structure would be built at Bayou des Allemands. Levee alignment would proceed northeast from east side of Bayou Des Allemands to join with the west Davis Pond guide levee east of Boutte, Louisiana. Additionally, ecosystem restoration activities and interior drainage issues will be investigated in the Lac des Allemands drainage basin between Donaldsonville and Des Allemands Louisiana.

Environmental and economic analysis will be used to determine the most practical plan, which would provide for the greatest overall public benefit. Alternatives recommended for consideration include several levee alignments along the east side of the Bayou Lafourche corridor in the vicinity of the wetland/cropland interface. Alternative alignments along the Bayou des Allemands to Davis Pond guide levee corridor would follow existing St. Charles Parish levees or along routes for which the parish has obtained permits. Alternatives will be investigated for levees of various elevations and widths that provide varying levels of protection, to determine the plan with the highest net benefits.

Alternatives will be investigated for several locations where levee would intersect Bayou des Allemands.

Ecosystem restoration alternatives being considered include a freshwater diversion from the Mississippi River, breaching of existing spoil banks to create more overland flow of water through the basin, and drainage improvements to prevent stagnation.

Scoping is the process for determining the range of alternatives and significant issues to be addressed in the EIS. For this analysis, a letter will be sent to all parties believed to have an interest in the analysis, requesting their input on alternatives and issues to be evaluated. The letter will also notify interested parties of public scoping meetings that will be held in the local area. Notices will also be sent to local news media. All interested parties are invited to comment at this time, and anyone interested in this study should request to be included in the study mailing list.

A series of public scoping meetings will be held in October and November 2002. Possible meeting site are in the vicinity of Hahnville, Vacherie, Edgard, Gheens, Chackbay, Napoleonville and Donaldsonville, Louisiana. Additional meetings could be held, depending upon interest and if it is determined that further public coordination is warranted.

The tentative list of resources and issues to be evaluated in the EIS includes wetlands (marshes and swamps), bottomland hardwoods, agricultural lands, wildlife resources, aquatic resources including fisheries and essential fish habitat, water quality, air quality, threatened and endangered species, recreation resources, and cultural resources. Socioeconomic items to be evaluated in the EIS include navigation, flood protection, business and industrial activity, employment, land use, property values, public/community facilities and services, tax revenues, population, community and regional growth, transportation, housing, community cohesion, and noise.

The U.S. Fish and Wildlife Service (USFWS) will be assisting in the documentation of existing conditions and the assessment of effects of project alternatives through the Fish and Wildlife Coordination Act consultation procedures. The USFWS will provide a Fish and Wildlife Coordination Act report. Consultation will be accomplished with the USFWS and the National Marine Fisheries Service (NMFS) concerning threatened and endangered species and their critical habitat. The NMFS will be consulted on the effects of this proposed action on Essential Fish Habitat. The draft EIS or a notice of its availability will be distributed to all interested agencies, organizations, and individuals.

Funding levels will dictate the date when the draft EIS is available. The earliest that the draft EIS is expected to be available in the fall of 2004.

1. Title: Method and Device for Securing a Knot. A device for securing a knot in a tight condition in a cord includes a generally tubular member defining a longitudinal hole therethrough. The Tubular member includes a score line for dividing it into two sections by applying a bending or torsional force on the ends thereof. The tubular member further includes a longitudinal slit extending substantially through the thickness thereof. A pre-stretched elastomeric band is disposed around the tubular member.

Serial No.: 09/645,517.

Date: 8/25/2000.

2. Title: System and Method for Visually Calculating and Displaying the Status of an Account. A graphical user interface (GUI) is provided a user to facilitate entry and maintenance of accounting information. It requires little or no apriori knowledge of accounting principles and thus is amenable for use by unskilled personnel. The system incorporates a “put and take” methodology. By entering an amount in a cell, i.e., “putting,” a user establishes a balance within that cell. The balance may be reduced by associated amounts with arrows from that cell to another, i.e., “taking,” to indicate a transfer of all or part of that balance. Each cell may be color coded to enable a user to readily ascertain the status of various cells within the GUI representing accounting information of interest. Although money is a common commodity tracked via accounting, any commodity that needs to be tracked, including commercial goods, fungible items, or data representing scientific results.

Serial No.: 09/662,460.

Date: 9/15/2000.

3. Title: Intelligent Amplifier System. Provided is a system and method for concurrently adjusting parameters of a system incorporating separate devices. In a preferred embodiment, a series of amplifiers used in an instrumentation system are able to be adjusted and calibrated concurrently via a simple operation of an unskilled operator. One option provides for this adjustment to occur remotely from the devices.

Serial No.: 09/730,566.

Date: 12/07/2000.

4. Title: Survey Flag Positioning Method and Apparatus. A device for placing survey flags, and similar devices having stems, is operated so that the stem is locked or otherwise held to an elongated shaft or similar aligning device. Pressure on the shaft or aligning device forces a portion of the flag stem into the soil or other sound substrate. Then, an operator can carry out an operation to separate the placing device from the stem.

Serial No.: 09/779,051.

Date: 12/08/2001.

5. Title: Durable System for Controlling the Disposition of Expended Munitions Fired at a Target Positioned Close to the Shooter. To reduce ricochet and backsplash of material impacted by expended munitions at close range, behind a single target is placed a screen of durable internal elements that are much longer than they are wide. The long dimension of each of these internal elements is terminated on at least one of its ends in a tapered configuration. With the tapered configuration facing the shooter, the elements are stacked between durable strong blocks so as to support them. The stacking configuration and shape of the elements provide spaces between each element for debris and projectiles to be directed away from the shooter to a backstop located behind the screen. In a preferred embodiment the screen comprises a 2.4 m by 2.4 m by 1.2 m deep structure incorporating replaceable internal elements of concrete logs of about 15 cm diameter and 1.2 m length with a conical end section of length 30 cm.

Serial No. : 09/801,175.

Date : 3/05/2001.

6. Title : Device for Removing Sludge From The Bottom of a Lagoon. A device for removing sludge from a lagoon, includes an elongated frame including first and second end portions. The frame includes first and second laterally spaced runners defining a recess there between. A scoop is positioned in the recess and includes an inclined bottom. One of the first and second end portions includes an opening, which is in fluid communication with the scoop for allowing the sludge to flow therein. A pump is operably connected to the scoop for pumping the sludge collected in the scoop to a remote location.

Serial No. : 09/875,988.

Date : 06/08/2001.

7. Title : Scour Sensor Assembly. A system for efficiently and cost effectively monitoring the status of the interface between two dissimilar media is provided. The system uses principles applied from the theory of time domain reflectometry (TDR), together with novel circuitry and low cost narrow band telemetry, to provide real time monitoring on a continuous basis, as needed. The circuitry involved permits operation of the system without relying on relative values of signal amplitude and a novel feedback function that sets the pulse repetition frequency instantaneously to permit an optimum data collection rate as well as a separate measure of the status based on the system operating parameters. It has particular application to real time monitoring and alerting to the effect of scour events in.

Serial No. : 09/879,001.

Date : 6/13/2001.

8. Title : Ultra-wide Band Soil/Tire Interaction Radar. A radar system for vehicle tire testing and analysis may be mounted within the casing of a vehicle tire to measure the location of the inner casing of the tire (tire footprint). The radar system of the present invention may also be used to determine soil characteristics by analyzing the reflected signals. The present invention may have particular use in testing tires for use with on or off-road surfaces. However, the present invention may also be used to monitor tire deformation, traction, footprint, and soil characteristics.

Serial No. : 09/882,408.

Date : 6/15/2001.

9. Title : Device, and Method of its use, for Concurrent Real Time Alerting to Accumulation of Material Upon Multiple Areas of a Surface. A system is provided for detecting accumulation of material concurrently on multiple areas of a surface in real time. In one embodiment, it is used for detecting icing of airframes while in use or on the ground while awaiting use. It may use either Time domain Reflectometry (TDR) or Frequency Modulated Continuous Ware (FM-CW) sources to provide a known energizing signal to a transmission line sensor. The system ascertains the signals round trip travel time in the transmission line. As material accumulates around the transmission line sensor, the medium through which the signal propagates is indicated by the change in time for the signal to propagate in relation to propagation in a reference medium, e.g., air. By employing pre-specified spectral analysis algorithms and referencing to the dielectric constant of media of interest, a determination of the occurrence, located and the rate, and type of material accumulation can be made.

Serial No. : 10/015,784.

Date : 12/17/2001.

10. Title: Material, and Method of Producing it, for Immobilizing Heavy Metals Later Entrained Therein. Provided are an improved structural material for bullet traps and the like, a method of producing it, and a structure comprising it. The material is suitable for entraining and immobilizing projectiles and fine particles in a stick gel. It is prepared by mixing cement with a thickener to form a dry mixture. Water is mixed with a fine aggregate in a mixer. The dry mixture is combined with the aqueous mixture in the mixer to form a slurry. Calcium phosphate and an aluminum compound are added, mixing each separately until homogeneous. The density of the mixture is measured and an aqueous foam is added to adjust the density to a pre-specified level. Fibers are mixed into the adjusted mixture to form a homogeneous slurry that may be poured into a mold or in place at a construction site. Upon curing, the material may be used as a structural component.

Serial No.: 10/067,909.

Date: 02/08/2002.

11. Title: Nested Tapered Bags. Tapered bags are dispensed singly form a nested configuration. They may be made of plastic, paper, aluminum foil, or aluminum foil laminated with plastic. The bags are connected at the top by a strip that has a row of perforations between the strip and the top of each bag, the strips in turn attached to each other by conventional fasteners such as staples. The taper may be formed by folding the bags so that a dispensed bag may be unfolded to have a bottom as wide as the top. A row of closely spaced perforations along the connecting portion between any two bags allows a single outermost bag to be separated by pulling and tearing along the row of perforations.

Serial No.: 10/086,702.

Date: 3/04/2002.

12. Title: Modular Barrier System for Satisfying Needs Unique to a Specific User. Provided are components, a system, and method of implementing the system, for controlling access and egress. In a preferred embodiment, the user's requirements are considered in providing a properly scaled barrier for such varied uses as security, safety, order, privacy, and discipline. In one embodiment, pre-manufactured panels and connectors are delivered to a site that has been properly prepared for installation of the system. Local materials may be used for the panels in some cases. The panels and connectors may be assembled quickly by unskilled labor and, in some embodiments, the barrier just as quickly dismantled or repaired as necessary. One embodiment may be used as a temporary or emergency solution to access control. Another embodiment may be used in a residential setting, providing storage in some installations. In all embodiments, accessories for enhancing effectiveness may be installed on or within the barrier.

Serial No.: 01/096,922.

Date: 03/14/2002.

13. Title: System and Method for Bioremediating Wastestreams Containing Energetics. A bioremediation system converts a waste stream, at least part of which is a fluid containing energetics, to carbon dioxide (CO2), water and environmentally benign end products. It uses gas-enhanced sequencing-batch-reactors 9SBRs), treating the waste stream in three SBRs seriatim. The first SBR uses a nitrogen purge, the second a hydrogen gas supplement, and the third an oxygen gas or forced air supplement. Each reactor may be supplemented with additives to optimize conditions such as pH, dissolve oxygen, and nutrient level. The system may be implemented under manual control, semi-automated, or fully automated, as needed. A waste stream of consideration is the pink water resultant from munitions fabrication and handling.

Serial No: 10/096,659.

Date: 3/14/2002.

14. Title: Process and System for Treating Waste From the Production of Energetics. A waste stream from energetics processing is treated using a pre-filter having media, preferably sand, and a metal that has a reducing potential, preferably elemental iron (Fe 0 ). The pre-filter is connected to a zero-valent metal column reactor. The waste stream is pumped through the pre-filter to trap solids and deoxygenate it, then enters the reactor and is subjected to a reducing process. Most of the Fe 2 is transformed to the ferrous ion (Fe + 2 ), added to the resultant products, and fed to a continuous stirred tank reactor (CSTR) in which Fenton oxidation occurs. This product is then sent to a sedimentation tank and pH-neutralized using a strong base such as sodium hydroxide (Na OH ). The aquesous portion is drawn off and the sludge pumped from the sedimentation tank. Both tanks are monitored and controlled to optimize required additives, while monitoring of pressure drop across the pre-filter and column reactor establishes replacement requirements.

Serial No.: 10/097,089.

Date: 3/14/2002.

15. Title: Reactive Geocomposite for Remediating Contaminated Sediments. In one application for remediating sediments, employing a geocomposite sheet eliminates the need for a thick cap or removal and subsequent ex situ treatment of the sediment. A geocomposite with at least one layer of reactive material is placed over the area to be remediated. A layer of available surcharge materials such as sand, gravel, or riprap covers the geocomposite. The weight of the surcharge materials causes pore water to flow from the sediment through the reactive layer or layers of the geocomposite. Contaminants may be trapped in this reactive layer or layers. A top or bottom layer, or both a top and bottom layer, may be provided to inhibit incursion from outside the sediment layer, while permitting appropriate flow direction or pore water into the reactive layer or layers.

Serial No.: 10/115,088.

Date: 4/04/2002.

16. Title: System and Method for Determining Status of an Object by Insonification. A flexible piezoelectric-based transducer, mounted on a circumference of a rotating object senses acoustical energy traversing portions of the object. In a preferred embodiment, the transducer is affixed, using a suitable adhesive, within the enclosed portion of a wheel/tire assembly. The transducer sense acoustical energy, e.g., ultrasonic transmissions, generated by the tire contracting the road surface at its contact patch and, without need of external power, translates it to an electrical current and communicates it for further processing. Because the acoustical impedance of the tire casing changes with temperature, hot spots within the tire, as well as other characteristics of the tire's operation, can be detected. Further, any Doppler shift, which occurs due to the rotating medium may be compensated for since the rate of tire rotation may be made known via a speed sensor. A position sensor may also be employed to indicate the position of the hot spot.

Serial No.: 10/118,001.

Date: 4/09/2002.

17. Title: Apparatus and Methods For Determining Self-Weight Consolidation And Other Properties of Media. Provided is a consolidometer and methods of its use. In its preferred embodiment, the device and methods permit accurate and convenient laboratory sampling of the self-weight consolidation of media, such as soft soil and soil slurries that may result from dredging operations. One option also provides for attaching sensors at locations along the consolidometer for taking data on additional characteristics of the media.

Serial No.: 10/118,012.

Date: 4/09/2002.

18. Title: System and Method for Separate Devices Concurrently. Within a few seconds, parameters of separate devices within a system may be adjusted concurrently. In one embodiment, multiple amplifers used in an instrumentation system are able to be biased and calibrated concurrently with final stage gain control via a simple operation of an unskilled operator. Remote adjustment of devices is also possible.

Serial No.: 10/139,373.

Date: 5/07/2002.

19. Title: Electro-Osmotic Pulse (EOP) System Incorporating a Durable Dimensionally Stable Anode and Method of use Therefore. A system and method for treating porous material, e.g., concrete, brick, or other masonry material, via electroosmosis. One application carries dehydration to an extend that it weakens a structure for demolition by significantly dehydrating its structural material. A durable, dimensionally stable anode is affixed to the structure and attached to a wire from a DC power supply. The anode is composed of a value metal substrate with a semi-conductive coating of a precious metal, cement or ceramic. Connection to a cathode through the power supply completes the circuit. A DC voltage is applied to the concrete structure by cycling a prespecified pulse train from the power supply. One pulse train consists of an initial positive pulse followed by a shorter duration negative pulse and ends with a short off period before the pulse train is reinitiated. The cycle continues until the porous material has been determined to be sufficiently treated.

Serial No.: 10/140,875.

Date: 5/09/2002.

20. Title: Method and Apparatus for Treating Volatile Organic Compounds, Odors and Biodegradable Aerosol/Particulates In Air Emissions. A biofilter reactor included a housing, an axial pipe ratably supported in the housing and including a plurality of perforations that open into the interior of the housing for collecting a treated fluid. The axial pipe includes an outlet in communication with the interior thereof for removing the treated fluid from the housing. A porous medium is disposed about the axial pipe and is rotatable therewith. The porous medium is made of a microbial foam.

Serial No.: 09/881,188.

Date: 6/15/2001.

21. Title: Roll of Tapered Bags Suitable for Dispensing Bags Singly. Tapered bags are dispensed singly from a roll. They may be made of plastic, paper, aluminum foil, or aluminum foil laminated with plastic. The bags are connected on the roll alternately top-to-top and bottom-to-bottom. Each bag is tapered towards its bottom such that its top-to-top connection with the next bag is wider than the bottom-to-bottom connection. The taper may be formed by folding the bags so that a dispensed bag may be unfolded to have a bottom as wide as the top. Each bottom-to-bottom connection separates the bags along a row of perforations adjacent to a sealed seam of each bag that defines the bag and insures its integrity. A row of closely spaced perforations along the connecting portion between any two bags allows a single end bag to be separated by pulling and tearing along the row of perforations.

Serial No.: 10/086,731.

Date: 3/04/2002.

The nation is commemorating the 30th anniversary of the passage of Title IX, the landmark legislation prohibiting recipients of Federal funds from discriminating on the basis of sex. Since this legislation was enacted, there has been a dramatic increase in the number of women participating in athletics at the high school and college levels. The Secretary of Education has determined that this anniversary provides an appropriate time to review the application of Title IX to educational institutions' efforts to provide equal opportunity in athletics to women and men. In order to do so, the Secretary established the Commission on Opportunity in Athletics. The Commission will produce a report no later than January 31, 2002, outlining its findings relative to the opportunities for men and women in athletics in order to improve the effectiveness of Title IX.

Comments are encouraged on the following priority areas:

1. Are Title IX standards for assessing equal opportunity in athletics working to promote opportunities for male and female athletes?

2. Is there adequate Title IX guidance that enables colleges and school districts to know what is expected of them and to plan for an athletic program that effectively meets the needs and interests of their students?

3. Is further guidance or are other steps needed at the junior and senior high school levels where the availability or absence of opportunities will critically affect the prospective interests and abilities of student athletes when they reach college age?

4. How should activities such as cheerleading or bowling factor into the analysis of equitable opportunities?

5. How do revenue producing and large-roster teams affect the provision of equal athletic opportunities? The Department has heard from some parties that whereas some men athletes will “walk-on” to intercollegiate teams—without athletic financial aid and without having been recruited—women rarely do this. Is this accurate and, if so, what are its implications for Title IX analysis?

6. In what ways do opportunities in other sports venues, such as the Olympics, professional leagues, and community recreation programs, interact with the obligations of colleges and school districts to provide equal athletic opportunity? What are the implications for Title IX?

7. Apart from Title IX enforcement, are there other efforts to promote athletic opportunities for male and female students that the Department might support, such as public-private partnerships to support the efforts of schools and colleges in this area?

You may view this document, as well as all other Department of Education documents published in the Federal Register , in text or Adobe Portable Document Format (PDF) on the Internet at the following site: http://www.ed.gov/legislation/FedRegister.

To use PDF you must have Adobe Acrobat Reader, which is available free at this site. If you have questions about using PDF, call the U.S. Government Printing Office (GPO), toll free, at 1-888-293-6498; or in the Washington, DC, area at (202) 512-1530.

Section 515 of the Treasury and General Government Appropriations Act for Fiscal Year 2001 (Public Law 106-554) requires all Federal agencies covered by the Paperwork Reduction Act (44 U.S.C. Chapter 35), including the Department of Education, to issue guidelines by October 1, 2002, for the purpose of “ensuring and maximizing the quality, objectivity, utility, and integrity of information (including statistical information) disseminated by the agency.” (Public Law 106-554). The agency guidelines must be consistent with government-wide guidelines published by the Office of Management and Budget (66 FR 49718, September 28, 2001; 67 FR 8452, February 22, 2002) and must include “administrative mechanisms allowing affected persons to seek and obtain correction of information” that the agency maintains and disseminates, and that does not comply with the OMB or agency guidelines.

On May 1, 2002, the Department published in the Federal Register (67 FR 21641) a request for public comments on the Department's draft information quality guidelines. On June 11, 2002, the Department published in the Federal Register (67 FR 39962) a notice reopening and extending the public comment period. The Department received four sets of public comments on the guidelines. Three sets of comments were general suggestions that were addressed to all agencies and did not specifically address the Department's guidelines, e.g. , suggestions for how to define terms, set deadlines for review, and establish a correction and appeal process. These comments were considered and, where appropriate, suggested changes have been incorporated into the final guidelines.

The Department did receive one set of comments specifically on its guidelines. That commenter suggested that the Department should: (1) Categorize the types of data the Department would consider as “influential information”; (2) provide more detailed guidance to the program offices with respect to the level of correction and the corresponding action to be taken; and (3) only decide not to process a request for correction if it is made in bad faith.

With respect to the first suggestion, the final guidelines include an expanded definition of influential information and examples of some of the types of data that would fall into this category. With respect to the second suggestion, the Department has not made any changes in the final guidelines; the Department believes that the appropriate program office will exercise good judgment in determining whether a correction is necessary and, if so, what that correction should be. In addition, the ability of the requester to appeal to the Chief Information Officer for an impartial review that is conducted by parties other than those who prepared the Department's initial decision serves as an opportunity for the Department to reconsider whether the initial decision was appropriate. Finally, with respect to the third suggestion, the Department has revised the final guidelines to state that the Department “may reject a request that appears to be made in bad faith or without justification, and is only required to undertake the degree of correction that it concludes is appropriate for the nature and timeliness of the information involved. In addition, the Department need not respond substantively to requests that concern information not covered by the information quality guidelines.”

In addition, the National Center for Education Statistics (NCES) received substantive comments on its standard for Maintaining Confidentiality. In response to those comments, NCES expanded the discussion of laws in the standard and clarified the language required for a confidentiality pledge.

You may view this document, as well as all other Department of Education documents published in the Federal Register , in text or Adobe Portable Document Format (PDF) on the Internet at the following site: http;//www.ed.gov/legislation/FedRegister.

To use PDF you must have Adobe Acrobat Reader, which is available free at this site. If you have questions about using PDF, call the U.S. Government Printing Office (GPO), toll free, at 1-888-293-6498; or in the Washington, DC, area at (202) 512-1530.

Title: NSPS for Municipal Solid Waste Landfills, 40 CFR part 60, subpart WWW. (OMB Control No. 2060-0220; EPA ICR Number 1557.05) expiring September 30, 2002. This is a request for extension of a currently approved collection.

Abstract: The Standards of Performance for Municipal Solid Waste Landfills; 40 CFR part 60, subpart WWW, were promulgated on March 12, 1996. These standards apply to municipal solid waste landfills for which construction, modification or reconstruction commences on or after May 30, 1991. The rule requires the installation of properly designed emission control equipment, and the proper operation and maintenance of this equipment. These standards rely on the capture and reduction of methane, carbon dioxide, and nonmethane organic gas compound emissions by combustion devices (boilers, internal combustion engines, or flares).

Owners and operators of the affected facilities described must make initial reports when a source becomes subject, conduct and report on performance tests, report of annual or periodic emission rates, report on design plans, report on equipment removal and closure, as well as maintain records of the reports, system design and performance tests, monitoring and exceedances, plot map, and well locations.

Any owner or operator subject to the provisions of this part must maintain a file of the applicable reporting and recordkeeping requirements for at least five years following the collection of such measurements, maintenance reports, and records. All reports are sent to the delegated state or local authority.

An agency may not conduct or sponsor, and a person is not required to respond to, a collection of information unless it displays a currently valid OMB Control Number. The OMB control numbers for EPA's regulations are listed in 40 CFR part 9 and 48 CFR Chapter 15. The Federal Register document required under 5 CFR 1320.8(d), soliciting comments on this collection of information was published on January 30, 2002 at 67 FR 4421. No comments were received on the notice.

Burden Statement: The annual public reporting and recordkeeping burden for this collection of information is estimated to average 11 hours per response. Burden means the total time, effort, or financial resources expended by persons to: generate, maintain, retain, disclose, or provide information to or for a Federal agency. This includes the time needed to review instructions; develop, acquire, install, and utilize technology and systems for the purposes of collecting, validating, and verifying information, processing and maintaining information, and disclosing and providing information; adjust the existing ways to comply with any previously applicable instructions and requirements; train personnel to be able to respond to a collection of information; search data sources; complete and review the collection of information; and transmit or otherwise disclose the information.

Respondents/Affected Entities: Owners and/or operators of municipal solid waste landfills.

Estimated Number of Respondents: 175.

Frequency of Response: On occasion, Quarterly, and Annually.

Estimated Total Annual Hour Burden: 3390 hours.

Estimated Total Annualized Capital, O&M Cost Burden: $107,000.

Send comments on the Agency's need for this information, the accuracy of the provided burden estimates, and any suggested methods for minimizing respondent burden, including through the use of automated collection techniques to the previous addresses. Please refer to EPA ICR No.1557.05 and OMB Control No. 2060-0220 in any correspondence.

Electronic Copies: Electronic copies of this document are available from the EPA Home Page under the link “Laws and Regulations” at the Federal Register —Environmental Documents entry ( http://www.epa.gov/fedrgstr ).

IPSCO Steel, Inc., a steel manufacturer located in Muscatine, Iowa and incorporated in the State of Delaware, disclosed, pursuant to the EPA “Incentives for Self-Policing: Discovery, Disclosure, Correction and Prevention of Violations' (“Audit Policy”), 65 FR 19618 (April 11, 2000), that its SPCC plan failed to include a reference to each of the guidelines found in 40 CFR 112.7, in violation of the CWA section 311(b)(3). Respondent disclosed that it had failed to record furnace pressure, fan amps, and damper positions on a “once-per-shift” basis. The NSPS for EAFs, 40 CFR part 60, subpart AAa, requires that furnace pressure, fan amps, and damper positions be checked and recorded on a “once-per-shift” basis. The failure to record these readings during separate shifts is a violation of 40 CFR 60.274a(b) and CAA section 111, 42 U.S.C. 7411. Respondent disclosed that it failed to maintain a logbook resulting in violations of requirements in its PSD permit no. 94-A-561-S1 to (1) maintain records of startup, shutdown, and malfunction of its two coiling reheat furnaces; (2) monitor the inlet combustion air temperature and furnace combustion chamber temperature and record any times that the temperature exceeds 2100°F; and (3) monitor percent of excess air supplied to the burners and record times when excess air exceeds 10 percent. Respondent disclosed that it failed to use “emulsion” for dust suppression on the slag-haul road in violation of its PSD permit no. 94-A-555-S1. IPSCO's outside contractor, Heckett Multiserve, used water rather than emulsion. Respondent disclosed that three rolloff boxes containing hazardous waste K061 and a 55-gallon drum of spent ethyl acetate were not properly labeled. IPSCO did not properly label rolloff boxes and drum with the words “Hazardous Wastes” and the date accumulation commenced, as required by 40 CFR 262.34(a). IPSCO disclosed that its RCRA contingency plan did not identify specifically the location of emergency response and communication equipment in the areas surrounding the emission control baghouse and other areas where hazardous materials are managed, as required by 40 CFR 262.34(a), which incorporates by reference 40 CFR 265.52(e). Respondent disclosed that its RCRA training records were deficient. The records did not include a written job title and description for each position that involves hazardous wastes and the names of those filling each position. Although this information is available at the plant, 40 CFR 262.34, which incorporates by reference 40 CFR 265.16, requires that this information be maintained in one location. Respondent disclosed that its universal waste training program was deficient. IPSCO did not incorporate universal waste training into its RCRA training, which it provides to all employees, as required by 40 CFR 273.16. Finally, Respondent disclosed that three drums of used oil were not properly labeled. IPSCO did not have “used oil” labels on three drums containing used oil as required by 40 CFR 279.22.

EPA determined that Respondent met the criteria set out in the Audit Policy for a 100% waiver of the gravity component of the penalty for the CWA violation and certain CAA and RCRA violations. However, Respondent failed to satisfy some of the conditions set forth in the Audit Policy for certain CAA and RCRA violations and was assessed an appropriate and fair civil penalty ($16,790) to settle those violations. As a result, for those violations meeting the audit policy, EPA waived the gravity based penalty ($186,989) and proposed a settlement penalty amount of two thousand, nine hundred and fifty-three dollars ($2,953). Of this amount, $2,809 is attributable to the CAA violations; $77 is attributable to the RCRA violations; and $67 is attributable to the CWA violation. This is the amount of the economic benefit gained by Respondent, attributable to its delayed compliance with the CWA, RCRA, and CAA regulations. The total civil penalty assessed for settlement purposes is nineteen thousand seven hundred and forty-three dollars ($19,743). Respondent has agreed to pay this amount. EPA and Respondent negotiated and reached an administrative consent agreement, following the Consolidated Rules of Practice, 40 CFR 22.13(b), on September 26, 2002 ( In Re: IPSCO Steel, Inc. Docket Nos. CWA-HQ-2001-6013, CAA-HQ-2001-6013, RCRA-HQ-2001-6013). This consent agreement is subject to public notice and comment under CWA section 311(b)(6), 33 U.S.C. 1321(b)(6).

Under CWA section 311(b)(6)(A), 33 U.S.C. 1321(b)(6)(A), any owner, operator, or person in charge of a vessel, onshore facility, or offshore facility from which oil is discharged in violation of the CWA section 311(b)(3), 33 U.S.C. 1321(b)(3), or who fails or refuses to comply with any regulations that have been issued under CWA section 311(j), 33 U.S.C. 1321(j), may be assessed a Class II civil penalty of up to $137,500 by EPA. Class II proceedings under CWA section 311(b)(6) are conducted in accordance with 40 CFR part 22.

The procedures by which the public may comment on a proposed Class II penalty order, or participate in a Clean Water Act Class II penalty proceeding, are set forth in 40 CFR 22.45. The deadline for submitting public comment on this proposed final order is November 4, 2002. All comments will be transferred to the Environmental Appeals Board (“EAB”) of EPA for consideration. The powers and duties of the EAB are outlined in 40 CFR 22.4(a).

Pursuant to CWA section 311(b)(6)(C), EPA will not issue an order in this proceeding prior to the close of the public comment period.

Compliance program guidance is a major initiative of the OIG in its effort to engage the health care community in preventing and reducing fraud and abuse in Federal health care programs. The purpose of the compliance program guidance is to encourage the use of internal controls to efficiently monitor adherence to applicable statutes, regulations and program requirements. In the last several years, the OIG has developed and issued compliance program guidance directed at the following segments of the health care industry: The hospital industry; home health agencies; clinical laboratories; third-party medical billing companies; the durable medical equipment, prosthetics, orthotics and supply industry; Medicare+Choice organizations offering coordinated care plans; hospices; nursing facilities; and individual and small group physician practices. The OIG has also issued draft guidance directed at ambulance suppliers. Copies of these compliance program guidances can be found on the OIG Web site at http://oig.hhs.gov/fraud/complianceguidance.html.

On June 11, 2001, the OIG published a solicitation notice seeking information and recommendations for developing compliance program guidance for the pharmaceutical industry (66 FR 31246). In response to that solicitation notice, the OIG received eight comments from various outside sources. In developing this draft guidance for formal public comment, we have considered those comments, as well as previous OIG publications, such as other compliance program guidances and Special Fraud Alerts. In addition, we have taken into account past and ongoing fraud investigations conducted by the OIG's Office of Investigations and the Department of Justice, and have consulted with the Centers for Medicare and Medicaid Services (CMS) (formerly known as the Health Care Financing Administration).

This draft guidance for pharmaceutical manufacturers contains seven elements that have been widely recognized as fundamental to an effective compliance program:

• Implementing written policies and procedures;

• Designating a compliance officer and compliance committee;

• Conducting effective training and education;

• Developing effective lines of communication;

• Conducting internal monitoring and auditing;

• Enforcing standards through well-publicized disciplinary guidelines; and

• Responding promptly to detected problems and undertaking corrective action.

These elements are included in previous guidances issued by the OIG. As with previously-issued guidances, this draft compliance program guidance represents the OIG's suggestions on how pharmaceutical manufacturers can establish internal controls to ensure adherence to applicable rules and program requirements. The contents of this guidance should not be viewed as mandatory or as an exclusive discussion of the advisable elements of a compliance program. The document is intended to present voluntary guidance to the industry and not represent binding standards for pharmaceutical manufacturers.

Although the June 11, 2001, solicitation notice requested information and recommendations for developing a compliance program guidance for the pharmaceutical industry generally, the OIG has since decided to focus this draft compliance program guidance specifically on pharmaceutical manufacturers and not to address other segments of the pharmaceutical industry, such as retail pharmacies. This decision was reached, in part, in response to comments from both pharmaceutical manufacturers and retail pharmacy chains, suggesting that the differences between pharmaceutical manufacturers and retail pharmacy chains, both in terms of operational issues and compliance issues, are significant enough to warrant addressing them separately.

In an effort to ensure that all parties have an opportunity to provide input into the OIG's guidance, we are publishing this guidance in draft form. We welcome any comments from interested parties regarding this document. The OIG will consider all comments that are received within the above-cited time frame, incorporate any specific recommendations as appropriate, and prepare a final version of the guidance thereafter for publication in the Federal Register . The final version of the guidance will be available though the OIG Web site at http://oig.hhs.gov.

The Office of Inspector General (OIG) of the Department of Health and Human Services is continuing in its efforts to promote voluntary compliance programs for the health care industry. This compliance guidance is intended to assist companies that develop, manufacture, market, and sell pharmaceutical drugs or biological products (pharmaceutical manufacturers) in developing and implementing internal controls and procedures that promote adherence to applicable statutes, regulations, and requirements of the Federal health care programs  1 and in evaluating and, as necessary, refining existing compliance programs.

This guidance provides the OIG s views on the fundamental elements of pharmaceutical manufacturer compliance programs and principles that each pharmaceutical manufacturer should consider when creating and implementing an effective compliance program. This guide is not a compliance program. Rather, it is a set of guidelines that pharmaceutical manufacturers should consider when developing and implementing a compliance program or evaluating an existing one. For those manufacturers with an existing compliance program, this guidance may serve as a benchmark or comparison against which to measure ongoing efforts.

A pharmaceutical manufacturer's implementation of an effective compliance program may require a significant commitment of time and resources by various segments of the organization. In order for a compliance program to be effective, it must have the support and commitment of senior management and the company's governing body. In turn, the corporate leadership should strive to foster a culture that promotes the prevention, detection, and resolution of instances of problems. Although an effective compliance program may require a reallocation of existing resources, the long-term benefits of establishing a compliance program significantly outweigh the initial costs.

In a continuing effort to collaborate closely with the pharmaceutical industry, the OIG published a notice in the Federal Register soliciting comments and recommendations on what should be included in this compliance program guidance. 2 In addition to considering the comments received in response to that solicitation notice, in drafting this guidance we reviewed previous OIG publications, including OIG advisory opinions, safe harbor regulations (including the preambles) relating to the Federal anti-kickback statute, 3 Special Fraud Alerts, as well as reports issued by the OIG's Office of Audit Services and Office of Evaluation and Inspections relevant to the pharmaceutical industry. (These materials are available on the OIG Web page at http://oig.hhs.gov. ) In addition, we relied on the experience gained from investigations of pharmaceutical manufacturers conducted by OIG's Office of Investigations, the Department of Justice, and the state Medicaid Fraud Control Units.

The OIG believes a comprehensive compliance program provides a mechanism that addresses the public and private sectors' mutual goals of reducing fraud and abuse; enhancing health care provider operational functions; improving the quality of health care services; and reducing the cost of health care. Attaining these goals provides positive results to the pharmaceutical manufacturer, the government, and individual citizens alike. In addition to fulfilling its legal duty to avoid submitting false or inaccurate pricing or rebate information to any Federal health care program or illegal marketing activities, a pharmaceutical manufacturer may gain important additional benefits by voluntarily implementing a compliance program. The benefits may include:

• A concrete demonstration to employees and the community at large of the company's commitment to honest and responsible corporate conduct;

• An increased likelihood of preventing, or at least identifying, and correcting unlawful and unethical behavior at an early stage;

• A mechanism to encourage employees to report potential problems and allow for appropriate internal inquiry and corrective action; and

• Through early detection and reporting, minimizing any financial loss to the government and any corresponding financial loss to the company.

The OIG recognizes that the implementation of a compliance program may not entirely eliminate improper conduct from the operations of a pharmaceutical manufacturer. However, a good faith effort by the company to comply with applicable statutes and regulations as well as Federal health care program requirements, demonstrated by an effective compliance program, significantly reduces the risk of unlawful conduct and any penalties that result from such behavior.

Given the wide diversity within the pharmaceutical industry, there is no single best pharmaceutical manufacturer compliance program. The OIG recognizes the complexities of this industry and the differences among industry members. Some pharmaceutical manufacturers are small and may have limited resources to devote to compliance measures. Conversely, other companies are well-established, large multi-national corporations with a widely dispersed work force. Some companies may have well-developed compliance programs already in place; others only now may be initiating such efforts. The OIG also recognizes that pharmaceutical manufacturers are subject to extensive regulatory requirements in addition to fraud and abuse-related issues and that many pharmaceutical manufacturers have addressed these obligations through compliance programs. Accordingly, the OIG strongly encourages pharmaceutical manufactures to develop and implement or refine (as necessary) compliance elements that uniquely address the areas of potential problems, common concern, or high risk that apply to their own companies (or, as applicable, to the U.S. operations of their companies).

For example, although they are not exhaustive of all potential risk areas, the OIG has identified three major potential risk areas for pharmaceutical manufacturers: (1) Integrity of data used by state and Federal governments to establish payment; (2) kickbacks and other illegal remuneration; and (3) compliance with laws regulating drug samples. The risk areas are discussed in greater detail in section II.B.2. below. The compliance measures adopted by a pharmaceutical manufacturer should be tailored to fit the unique environment of the company (including its organizational structure, operations and resources, as well as prior enforcement experience). In short, the OIG recommends that each pharmaceutical manufacturer should adapt the objectives and principles underlying the measures outlined in this guidance to its own particular circumstances.

The OIG believes that every effective compliance program must begin with a formal commitment by the pharmaceutical manufacturer's board of directors or other governing body. Evidence of that commitment should include the allocation of adequate resources, a timetable for the implementation of the compliance measures, and the identification of an individual to serve as a compliance officer to ensure that each of the recommended and adopted elements is addressed. Once a commitment has been undertaken, a compliance officer should immediately be chosen to oversee the implementation of the compliance program.

The elements listed below provide a comprehensive and firm foundation upon which an effective compliance program may be built. Further, they are likely to foster the development of a corporate culture of compliance. The OIG recognizes that full implementation of all elements may not be immediately feasible for all pharmaceutical manufacturers. However, as a first step, a good faith and meaningful commitment on the part of the company's management will substantially contribute to the program's successful implementation. As the compliance program is implemented, that commitment should filter down through management to every employee and contractor of the pharmaceutical manufacturer, as applicable for the particular individual.

At a minimum, a comprehensive compliance program should include the following elements:

(1) The development and distribution of written standards of conduct, as well as written policies, procedures and protocols that verbalize the company's commitment to compliance ( e.g. , by including adherence to the compliance program as an element in evaluating management and employees) and address specific areas of potential fraud and abuse, such as the reporting of pricing and rebate information to the Federal health care programs, and sales and marketing practices;

(2) The designation of a compliance officer and other appropriate bodies ( e.g. , a corporate compliance committee) charged with the responsibility for developing, operating, and monitoring the compliance program, and with authority to report directly to the board of directors and/or the president or CEO;

(3) The development and implementation of regular, effective education and training programs for all affected employees;

(4) The creation and maintenance of an effective line of communication between the compliance officer and all employees, including a process (such as a hotline or other reporting system) to receive complaints or questions, and the adoption of procedures to protect the anonymity of complainants and to protect whistle blowers from retaliation;

(5) The use of audits and/or other risk evaluation techniques to monitor compliance, identify problem areas, and assist in the reduction of identified problems;

(6) The development of policies and procedures addressing the non-employment or retention of excluded individuals or entities, and the enforcement of appropriate disciplinary action against employees or contractors who have violated company policies and procedures and/or applicable Federal health care program requirements; and

(7) The development of policies and procedures for the investigation of identified instances of non-compliance or misconduct. These should include directions regarding the prompt and proper response to detected offenses, such as the initiation of appropriate corrective action and preventive measures.

In developing a compliance program, every pharmaceutical manufacturer should develop and distribute written compliance standards, procedures, and practices that guide the company and the conduct of its employees in day-to-day operations. These policies and procedures should be developed under the direction and supervision of the compliance officer, the compliance committee, and operational managers. At a minimum, the policies and procedures should be provided to all employees who are affected by these policies, and to any agents or contractors who may furnish services that impact Federal health care programs ( e.g. , contractors involved in the co-promotion of a manufacturer's products).

Although a clear statement of detailed and substantive policies and procedures is at the core of a compliance program, the OIG recommends that pharmaceutical manufacturers also develop a general corporate statement of ethical and compliance principles that will guide the company's operations. One common expression of this statement of principles is the code of conduct. The code should function in the same fashion as a constitution, i.e. , as a document that details the fundamental principles, values, and framework for action within an organization. The code of conduct for a pharmaceutical manufacturer should articulate the company's expectations of commitment to compliance by management, employees, and agents, and should summarize the broad ethical and legal principles under which the company must operate. Unlike the more detailed policies and procedures, the code of conduct should be brief, easily readable, and cover general principles applicable to all employees.

As appropriate, the OIG strongly encourages the participation and involvement of the pharmaceutical manufacturer s board of directors, CEO, president, members of senior management, and other personnel from various levels of the organizational structure in the development of all aspects of the compliance program, especially the code of conduct. Management and employee involvement in this process communicates a strong and explicit commitment by management to foster compliance with applicable Federal health care program requirements. It also communicates the need for all employees to comply with the organization's code of conduct and policies and procedures.

This section addresses the following major risk areas for pharmaceutical manufacturers: (1) Integrity of data used by state and Federal governments to establish payment; (2) kickbacks and other illegal remuneration; and (3) compliance with laws regulating drug samples. This section focuses on areas that are currently of most concern to the enforcement community and is not intended to be exhaustive of all potential risk areas for pharmaceutical manufacturers.

a. Integrity of Data Used to Establish Government Reimbursement . Many Federal and state health care programs establish reimbursement rates for pharmaceuticals, either prospectively or retrospectively, using price and sales data directly or indirectly furnished by pharmaceutical manufacturers. The government sets reimbursement with the expectation that the data provided are complete and accurate. The knowing submission of false, fraudulent, or misleading information is actionable. A pharmaceutical manufacturer may be liable under the False Claims Act, 4 if government reimbursement (including, but not limited to, reimbursement by Medicare and Medicaid) for the manufacturer s product depends, in whole or in part, on information generated or reported by the manufacturer, directly or indirectly, and the manufacturer has knowingly (as defined in the False Claims Act) failed to generate or report such information completely and accurately. Manufacturers may also be liable for civil money penalties under various laws, rules and regulations. Moreover, in some circumstances, inaccurate or incomplete reporting may be probative of liability under the Federal anti-kickback statute.

Where appropriate, manufacturers reported prices should accurately take into account price reductions, rebates, up-front payments, coupons, goods in kind, free or reduced price services, grants, or other price concessions or similar benefits offered to some or all purchasers. If a discount, price concession, or similar benefit is offered on purchases of multiple products, the discount, price concession, or similar benefit should be fairly apportioned among the products. Underlying assumptions used in connection with reported prices should be reasoned, consistent, and appropriately documented, and pharmaceutical manufacturers should retain all relevant records reflecting reported prices and efforts to comply with Federal health care program requirements.

Given the importance of the Medicaid Rebate Program, as well as other programs that rely on Medicaid Rebate Program benchmarks (such as the 340B Program  5 ), manufacturers should pay particular attention to ensuring that they are calculating Average Manufacturer Price and Best Price accurately and that they are paying appropriate rebate amounts for their drugs. 6

In sum, pharmaceutical manufacturers are responsible for ensuring the integrity of data they generate that is used for government reimbursement purposes.

b. Kickbacks and Other Illegal Remuneration . Pharmaceutical manufacturers, as well as their employees and agents, should be aware of the Federal anti-kickback statute, and the constraints it places on the marketing and promotion of products reimbursable by the Federal health care programs. The anti-kickback statute is a criminal prohibition against payments (in any form, whether the payments are direct or indirect) made purposefully to induce or reward referrals of Federal health care business. The anti-kickback statute potentially implicates not only the offer or payment of anything of value for patient referrals, but also the offer or payment of anything of value in return for purchasing, leasing, ordering, or arranging for or recommending the purchase, lease, or ordering of any item or service reimbursable in whole or part by a Federal health care program. Under certain circumstances, a violation of the anti-kickback statute may give rise to liability under the False Claims Act.

Activities that fit squarely in one of the safe harbors set forth in 42 CFR 1001.952 are deemed immune from sanction under the anti-kickback statute. We recommend that pharmaceutical manufacturers structure their arrangements to fit in a safe harbor whenever possible. Potentially relevant safe harbors include: personal services and management contracts, warranties, discounts, employees, group purchasing organization arrangements, and shared risk arrangements. Even where an arrangement cannot be structured to fit in a safe harbor, the safe harbor regulations (and accompanying Federal Register preambles) provide valuable guidance for assessing risk of abuse under the anti-kickback statute. In addition, parties seeking guidance about their particular arrangements may apply for an OIG advisory opinion using the procedures set out at 42 CFR part 1008.

The following discussion addresses key areas of potential risk under the anti-kickback statute arising from pharmaceutical manufacturers relationships with three groups: purchasers; physicians and other health care professionals; and sales agents. This discussion is intended to be illustrative, not exhaustive, of potential risk areas.

(1) Relationships with Purchasers. (a) Discounts and Other Terms of Sale. Pharmaceutical manufacturers offer customers a variety of price concessions and similar benefits to induce the purchase of their products. Such inducements potentially implicate the anti-kickback statute if the products are reimbursable to the customers, in whole or in part, directly or indirectly, by any of the Federal health care programs. Moreover, price concessions and similar benefits offered to a wholesaler potentially implicate the statute if the concessions or benefits are offered to induce the wholesaler to purchase the products and to recommend the products to, or arrange for the purchase of the products by, customers that submit claims to the Federal health care programs. Finally, incentive payments to GPOs, PBMs, and other persons or entities in a position to influence the purchase of a manufacturers's products, but that do not themselves purchase the products, also potentially implicate the anti-kickback statute.

Discounts. The anti-kickback statute contains a broad exception for discounts offered to customers that submit claims to the Federal health care programs, if the discounts are properly disclosed and accurately reported. See 42 U.S.C. 1320a-7b(b)(3)(A); 42 CFR 1001.952(h). However, to qualify for the exception, the discount must be in the form of a reduction in the price of the good or service based on an arms-length transaction. In other words, the exception covers only actual reductions in the product's price. Moreover, the regulations provide that the discount must be given at the time of sale or, in certain cases, set at the time of sale, even if finally determined subsequent to the time of sale ( i.e. , a rebate). Other kinds of price concessions (including, but not limited to, discounts on other products, other free or reduced price goods or services, “educational” or other grants, “conversion payments,” signing bonuses, or “up-front rebates”) do not qualify for the discount exception and should be carefully reviewed.

Manufacturers offering discounts should thoroughly familiarize themselves, and have their sales and marketing personnel familiarize themselves, with the discount safe harbor at 42 CFR 1001.952(h). In particular, manufacturers should pay attention to the safe harbor requirements applicable to “sellers” and “offerors” of discounts. Under the safe harbor, sellers and offerors have specific obligations that include (i) informing a customer of any discount and of the customer's reporting obligations with respect to that discount and (ii) refraining from any action that would impede a customer's ability to comply with the safe harbor. To fulfill the safe harbor requirements, manufacturers will need to know how their customers submit claims to the Federal health care programs ( e.g. , whether the customer is a managed care, cost-based, or charge-based biller).

Other terms of sale. Any remuneration provided as part of a sale, other than a price reduction covered by the discount exception, potentially implicates the anti-kickback statute. Non-price terms of sale make it difficult to ensure that the value of the remuneration is appropriately apportioned and accurately reported and that costs are not shifted disproportionately from private payers to the Federal health care programs. Arrangements involving such non-price terms should be evaluated on a case-by-case basis. Arrangements that may increase the risk of overutilization, higher government program costs, inappropriate steering of Federal health care business, or unfair competition are particularly suspect.

Pharmaceutical manufacturers sometimes offer certain services in connection with the sale of their products. Such services include, among other things, product-related billing assistance programs, reimbursement consultation, or other types of programs. Any time a pharmaceutical manufacturer provides free or below market rate goods or services to a purchaser (or other potential referral source, such as a physician who might prescribe a manufacturer s product or a PBM that might put it on a formulary), it should examine whether it is providing a valuable tangible benefit to the recipient with the intent to induce or reward referrals. For example, a manufacturer should examine whether the services are made available to all customers or only to a select group ( e.g. , high volume prescribers). If the purchaser or referral source is in a position to make or influence referrals, and if the goods or services provided by the manufacturer eliminate an expense that the purchaser or referral source would have otherwise incurred, the arrangement is likely to be problematic from a kickback perspective. Similarly, if a manufacturer provides a service having no independent value (such as limited reimbursement support services in connection with its own products) in tandem with another service or program that confers a benefit on a referring provider (such as one that eliminates normal financial risks), the arrangement could raise kickback concerns. For example, the anti-kickback statute would be implicated if a manufacturer were to couple a reimbursement support service with (i) a requirement that a purchaser pay for ordered products only if the purchaser is paid or (ii) a guarantee of a minimum “spread” between the purchase price and third party reimbursement levels.

(b) Average Wholesale Price . The “spread” is the difference between the amount a customer pays for a product and the amount the customer receives upon resale of the product to the patient or other payer. In many situations under the Federal programs, pharmaceutical manufacturers control not only the amount at which they sell a product to their customers, but also the amount those customers who purchase the product for their own accounts and thereafter bill the Federal health care programs will be reimbursed. A subset of the manufacturer's customers, including certain medical specialists, PBMs, HMOs, and institutional providers, are also in a position to influence substantially a physician's or other health care professional's selection of the product. To the extent that a manufacturer controls the “spread,” it controls its customer's profit.

Average Wholesale Price (AWP) is the benchmark often used to set reimbursement for prescription drugs under the Medicare Part B program. For covered drugs and biologicals, Medicare Part B generally reimburses at “95 percent of average wholesale price.” 42 U.S.C. 1395u(o). Similarly many state Medicaid programs and other payers base reimbursement for drugs and biologicals on AWP. Generally, AWP is reported directly by pharmaceutical manufacturers.

A pharmaceutical manufacturer's purposeful manipulation of the AWP to increase its customers profits by increasing the amount the Federal health care programs reimburse its customers implicates the anti-kickback statute. Unlike bona fide discounts, which transfer remuneration from a seller to a buyer, manipulation of the AWP transfers remuneration to a seller's immediate customer from a subsequent purchaser (the Federal or state government). Under the anti-kickback statute, offering remuneration to a purchaser or referral source is improper if one purpose is to induce the purchase or referral of program business.

In the light of this risk, the OIG recommends that manufacturers review their AWP reporting practices and methodology to confirm that marketing considerations do not influence the process. Furthermore, manufacturers should review their marketing practices. Manipulation of the AWP to induce customers to purchase a product, coupled with active marketing of the spread is evidence of the unlawful intent necessary to trigger the anti-kickback statute. Active marketing of the spread includes, for example, sales representatives promoting the spread as a reason to purchase the product or guaranteeing a certain profit or spread in exchange for the purchase of a product.

(2) Relationships with Physicians and Other Health Care Professionals . Pharmaceutical manufacturers and their agents may have a variety of remunerative relationships with physicians and other health care professionals who order or prescribe their products. As these relationships may implicate the anti-kickback statute, they should be examined carefully. Relationships with particular parties should be evaluated individually and in the aggregate. The following discussion highlights some of the most significant areas of potential risk.

“Switching” arrangements. As noted in the 1994 Special Fraud Alert (59 FR 65372; December 19, 1994), product conversion arrangements (also known as “switching” arrangements) are suspect under the anti-kickback statute. Switching arrangements involve pharmaceutical manufacturers offering pharmacies, PBMs, physicians or other prescribers cash payments or other benefits each time a patient's prescription is changed to the manufacturer's product from a competing product. This activity implicates the statute, and, while such programs may be permissible in certain managed care arrangements, manufacturers should review any marketing practices utilizing “switching” payments in connection with products reimbursable by Federal health care programs very carefully. In addition, arrangements that have the effect of rewarding switching indirectly should also be carefully reviewed. Such arrangements include payments by pharmaceutical manufacturers to pharmacies, PBMs, or others for contacting patients or their physicians to encourage them change a prescription from another product to the company's product, and discounts or rebates based on movement of market share.

Consulting and advisory payments. Pharmaceutical manufacturers frequently engage physicians and other health care professionals to act as “consultants,” “advisors,” or “researchers” in connection with various types of marketing and research activities. For instance, pharmaceutical manufacturers may engage physicians to perform research, data collection, and consulting services, to serve on advisory boards, to participate in focus groups, or to speak at meetings. While there may be legitimate purposes to these arrangements, they pose a substantial risk of fraud and abuse; without appropriate safeguards, they can result in payments for referrals.

Pharmaceutical manufacturers should ensure that they (and their sales agents) compensate health care professionals only for providing actual, reasonable, and necessary services and that the arrangements are not merely token arrangements created to disguise otherwise improper payments. Moreover, payments should be fair market value for the services rendered, and manufacturers should take steps to ensure appropriate documentation of the fair market value determination, as well as the performance of the services. Whenever possible, the OIG recommends that consulting and advisory arrangements be structured to fit in the personal services safe harbor (42 CFR 1001.952(d)).

Other remuneration . Pharmaceutical companies and their employees and agents engage in a number of other arrangements that offer benefits, directly or indirectly, to physicians or others in a position to make or influence referrals. These arrangements potentially implicate the anti-kickback statute. They include:

• Entertainment, recreation, travel, meals, or other benefits in association with information or marketing presentations;

• Sponsorship or other financing related to third-party educational conferences and meetings attended or taught by physicians or others in a position to generate or influence referrals;

• Scholarships and educational funds;

• Grants for research and education; and

• Gifts, gratuities, and other business courtesies.

These practices raise a particular risk where they involve parties in a position to prescribe or order the manufacturer's products or to influence such prescriptions or orders. These parties include physicians and other health care professionals, as well as PBMs, GPOs, hospital systems, and the like.

With respect to these practices, a good starting point for compliance purposes is the “PhRMA Code on Interactions with Healthcare Professionals” (the “PhRMA Code” ), a voluntary code promulgated by the Executive Committee of the Pharmaceutical Research and Manufacturers of America (PhRMA), that became effective July 1, 2002. It is available through PhRMA's Web site at http://www.phrma.org . The PhRMA Code provides useful guidance for evaluating relationships with physicians and other health care professionals. The OIG recommends that pharmaceutical manufacturers at a minimum comply with the standards set by the PhRMA Code. Arrangements that fail to meet the minimum standards set out in the PhRMA Code are likely to receive increased scrutiny from government authorities.

While the PhRMA Code provides important and practicable benchmarks for manufacturers and government when evaluating practices involving gifts, gratuities, and other benefits, it must be understood that compliance with the relevant sections of the PhRMA Code will not necessarily protect a manufacturer from prosecution or liability for illegal conduct. Thus, all arrangements should be reviewed with the following issues, among others, in mind:

• Is the gift or other benefit made to a person in a position to generate or influence business for the paying party?

• Does the gift or other benefit take into account, directly or indirectly, the volume or value of business generated ( e.g. , is the payment or gift only given to persons who have prescribed or agree to prescribe the product)?

• Is the gift or benefit more than nominal in value and/or does it exceed the fair market value of any legitimate service rendered to payer?

• Is the gift or benefit unrelated to any services at all other than the referral of Federal health care business?

(3) Relationships with Sales Agents . Sales agents, whether employees or independent contractors, are in the business of recommending or arranging for the purchase of the items or services they offer for sale on behalf of the pharmaceutical manufacturer they represent. Accordingly, any compensation arrangement between a pharmaceutical manufacturer and a sales agent for the purpose of selling health care items or services that are directly or indirectly reimbursable by a Federal health care program potentially implicates the anti-kickback statute, irrespective of the methodology used to compensate the agent. In addition, sales agents may engage in improper marketing and promotional activities that may give rise to manufacturer liability. Of particular concern are situations in which a sales agent's express or implied duties include offering or paying remuneration (in any form) to purchasers or prescribers of the pharmaceutical manufacturer's products or in which a sales agent's compensation methodology creates an undue incentive to engage in aggressive marketing or promotional practices.

As an initial matter, the safe harbors for personal services arrangements and employment, 42 CFR 1001.952(d) and (i), are available to protect many compensation arrangements with sales agents. While compliance with safe harbors is voluntary and failure to comply does not necessarily mean that an arrangement violates the anti-kickback statute, the OIG strongly recommends that manufacturers structure their relationships with their sales force to fit in a safe harbor whenever possible. Compensation arrangements with sales personnel that do not fit in a safe harbor should be reviewed carefully.

It is in a pharmaceutical manufacturer's best interests to: (i) Develop a regular and comprehensive training program for its sales force, including refresher and updated training on a regular basis, either in person or through newsletters, memoranda, or the like; (ii) institute and implement corrective action and disciplinary policies applicable to sales agents who engage in improper marketing; (iii) avail itself of the advisory opinion process if it has questions about particular practices used by its sales force; and (iv) establish an effective system for tracking, compiling, and reviewing information about sales force activities.

c. Drug Samples . The provision of drug samples is a widespread industry practice that can benefit patients, but can also be an area of potential risk to a pharmaceutical manufacturer. The Prescription Drug Marketing Act of 1987 (PDMA) governs the distribution of drug samples and forbids their sale. 21 U.S.C. 353(c)(1). A drug sample is defined to be a unit of the drug “that is not intended to be sold * * * and is intended to promote the sale of the drug”. 21 U.S.C. 353(c)(1). Failure to comply with the requirements of PDMA can result in PDMA sanctions. In some circumstances, if the samples have monetary value to the recipient ( e.g. , a physician) and are used to treat Federal health care program beneficiaries, the provision of samples may also trigger potential False Claims Acts or kickback liability.

Pharmaceutical manufacturers should closely follow the PDMA requirements (including all documentation requirements). In addition, manufacturers can minimize their risk of liability by (i) training their sales force to inform sample recipients in a meaningful manner that samples may not be sold or billed; (ii) clearly and conspicuously labeling individual samples as units that may not be sold; and (iii) including on packaging and any documentation related to the samples (such as shipping notices or invoices) a clear and conspicuous notice that the samples are subject to PDMA and may not be sold. Recent government enforcement activity has focused on instances in which drug samples were provided to physicians who, in turn, sold them to the patient or billed them to the Federal health care programs on behalf of the patient.

Every pharmaceutical manufacturer should designate a compliance officer to serve as the focal point for compliance activities. This responsibility may be the individual's sole duty or added to other management responsibilities, depending upon the size and resources of the company and the complexity of the task. If the individual has additional management responsibilities, the pharmaceutical manufacturer should ensure that the individual is able to dedicate adequate and substantive time and attention to the compliance functions. Similarly, if the compliance officer delegates some of the compliance duties, he or she should, nonetheless, remain sufficiently involved to fulfill the compliance oversight function.

Designating a compliance officer with the appropriate authority is critical to the success of the program, necessitating the appointment of a high-level official with direct access to the company's president or CEO, board of directors, all other senior management, and legal counsel. The compliance officer should have sufficient funding, resources, and staff to perform his or her responsibilities fully. The compliance officer should be able to effectuate change within the organization as necessary or appropriate and to exercise independent judgment. Optimal placement of the compliance officer within the organization will vary according to the particular situation of a manufacturer. 7

Coordination and communication with other appropriate individuals or business units are the key functions of the compliance officer with regard to planning, implementing or enhancing, and monitoring the compliance program. The compliance officer's primary responsibilities should include:

• Overseeing and monitoring implementation of the compliance program;  8

• Reporting on a regular basis to the company's board of directors, CEO or president, and compliance committee (if applicable) on compliance matters and assisting these individuals or groups to establish methods to reduce the company's vulnerability to fraud and abuse;

• Periodically revising the compliance program, as appropriate, to respond to changes in the company's needs and applicable Federal health care program requirements, identified weakness in the compliance program, or identified systemic patterns of non-compliance;

• Developing, coordinating, and participating in a multifaceted educational and training program that focuses on the elements of the compliance program, and seeking to ensure that all affected employees and management understand and comply with pertinent Federal and state standards;

• Ensuring that independent contractors and agents, particularly those agents and contractors who are involved in sales and marketing activities, are aware of the requirements of the company's compliance program with respect to sales and marketing activities, among other things;

• Coordinating personnel issues with the company's Human Resources/Personnel office (or its equivalent) to ensure that the List of Excluded Individuals/Entities  9 has been checked with respect to all employees and independent contractors;

• Assisting the company's internal auditors in coordinating internal compliance review and monitoring activities;

• Reviewing and, where appropriate, acting in response to reports of non-compliance received through the hotline (or other established reporting mechanism) or otherwise brought to his or her attention ( e.g. , as a result of an internal audit or by corporate counsel who may have been notified of a potential instance of non-compliance);

• Independently investigating and acting on matters related to compliance. To that end, the compliance officer should have the flexibility to design and coordinate internal investigations ( e.g. , responding to reports of problems or suspected violations) and any resulting corrective action ( e.g. , making necessary improvements to policies and practices, and taking appropriate disciplinary action) with various company divisions or departments;

• Participating with the company s counsel in the appropriate reporting of any self-discovered violations of Federal health care program requirements; and

• Continuing the momentum and, as appropriate, revision or expansion of the compliance program after the initial years of implementation. 10

The compliance officer must have the authority to review all documents and other information relevant to compliance activities. This review authority should enable the compliance officer to examine interactions with government programs to determine whether the company is in compliance with Federal health care program reporting and rebate requirements and to examine interactions with health care professionals that could violate kickback prohibitions or other Federal health care programs requirements. Where appropriate, the compliance officer should seek the advice of competent legal counsel about these matters.

The OIG recommends that a compliance committee be established to advise the compliance officer and assist in the implementation of the compliance program. 11 When developing an appropriate team of people to serve as the pharmaceutical manufacturer s compliance committee, the company should consider a variety of skills and personality traits that are expected from the team members. The company should expect its compliance committee members and compliance officer to demonstrate high integrity, good judgment, assertiveness, and an approachable demeanor, while eliciting the respect and trust of company employees. These interpersonal skills are as important as the professional experience of the compliance officer and each member of the compliance committee.

Once a pharmaceutical manufacturer chooses the people who will accept the responsibilities vested in members of the compliance committee, the company needs to train these individuals on the policies and procedures of the compliance program, as well as how to discharge their duties. The OIG recognizes that some pharmaceutical manufacturers ( e.g. , small companies or those with limited budgets) may not have the resources or the need to establish a compliance committee. However, when potential problems are identified at such companies, the OIG recommends the creation of a task force to address the particular issues. The members of the task force may vary depending upon the area of concern. For example, if the compliance officer identifies issues relating to improper inducements to the company's purchasers or prescribers, the OIG recommends that a task force be organized to review the arrangements and interactions with those purchasers or prescribers. In essence, the compliance committee is an extension of the compliance officer and provides the organization with increased oversight.

The proper education and training of officers, directors, employees, contractors, and agents, and periodic retraining of personnel at all levels are critical elements of an effective compliance program. A pharmaceutical manufacturer must take steps to communicate effectively its standards and procedures to all affected personnel by requiring participation in appropriate training programs and by other means, such as disseminating publications that explain specific requirements in a practical manner. These training programs should include general sessions summarizing the manufacturer's compliance program, written standards, and applicable Federal health care program requirements. All employees and, where feasible and appropriate, contractors should receive the general training. More specific training on issues, such as (i) the anti-kickback statute and how it applies to pharmaceutical sales and marketing practices and (ii) the calculation and reporting of pricing information and payment of rebates in connection with Federal health care programs, should be targeted at those employees and contractors whose job requirements make the information relevant. The specific training should be tailored to make it as meaningful as possible for the participants.

Managers and employees of specific divisions can assist in identifying specialized areas that require training and in carrying out such training. Additional areas for training may also be identified through internal audits and monitoring and from a review of any past compliance problems of the pharmaceutical manufacturer or similarly-situated companies. Training instructors may come from outside or inside the organization, but must be qualified to present the subject matter involved and sufficiently experienced in the issues presented to adequately field questions and coordinate discussions among those being trained. Ideally, training instructors should be available for follow-up questions after the formal training session has been conducted.

The pharmaceutical manufacturer should train new employees soon after they have started working. Training programs and materials should be designed to take into account the skills, experience, and knowledge of the individual trainees. The compliance officer should document any formal training undertaken by the company as part of the compliance program. The company should retain adequate records of its training of employees, including attendance logs, descriptions of the training sessions, and copies of the material distributed at training sessions.

The OIG suggests that all relevant personnel ( i.e. , employees as well as agents of the pharmaceutical manufacturer) participate in the various educational and training programs of the company. For example, for sales representatives who are responsible for the sale and marketing of the company's products, periodic training in the anti-kickback statute and its safe harbors should be required. Employees should be required to have a minimum number of educational hours per year, as appropriate, as part of their employment responsibilities.

The OIG recognizes that the format of the training program will vary depending upon the size and resources of the pharmaceutical manufacturer. For example, a company with limited resources or whose sales force is widely dispersed may want to create a videotape or computer-based program for each type of training session so new employees and employees outside of central locations can receive training in a timely manner. If videos or computer-based programs are used for compliance training, the OIG suggests that the company make a qualified individual available to field questions from trainees. Also, large pharmaceutical manufacturers may find training via the Internet or video conference capabilities to be a cost-effective means of reaching a large number of employees. Alternatively, large companies may include training sessions as part of regularly scheduled regional meetings.

The OIG recommends that participation in training programs be made a condition of continued employment and that failure to comply with training requirements should result in disciplinary action. Adherence to the training requirements as well as other provisions of the compliance program should be a factor in the annual evaluation of each employee.

In order for a compliance program to work, employees must be able to ask questions and report problems. Supervisors play a key role in responding to employee concerns and it is appropriate that they serve as a first line of communications. Pharmaceutical manufacturers should consider the adoption of open-door policies in order to foster dialogue between management and employees. In order to encourage communications, confidentiality and non-retaliation policies should also be developed and distributed to all employees. 12

Open lines of communication between the compliance officer and employees are equally important to the successful implementation of a compliance program and the reduction of any potential for fraud and abuse. In addition to serving as a contact point for reporting problems and initiating appropriate responsive action, the compliance officer should be viewed as someone to whom personnel can go to get clarification on the company's policies. Questions and responses should be documented and dated and, if appropriate, shared with other staff so that compliance standards or policies can be updated and improved to reflect any necessary changes or clarifications. Pharmaceutical manufacturers may also consider rewarding employees for appropriate use of established reporting systems as a way to encourage the use of such systems.

The OIG encourages the use of hotlines, e-mails, newsletters, suggestion boxes, and other forms of information exchange to maintain open lines of communication. In addition, an effective employee exit interview program could be designed to solicit information from departing employees regarding potential misconduct and suspected violations of company policy and procedures. Pharmaceutical manufacturers may also identify areas of risk or concern through periodic surveys or communications with sales representatives about the current marketing environment. This could provide management with insight about and an opportunity to address conduct occurring in the field, either by the company's own sale representatives or those of other companies.

If a pharmaceutical manufacturer establishes a hotline or other reporting mechanism, information regarding how to access the reporting mechanism should be made readily available to all employees and independent contractors by including that information in the code of conduct or by circulating the information ( e.g. , by publishing the hotline number or e-mail address on wallet cards) or conspicuously posting the information in common work areas. 13 Employees should be permitted to report matters on an anonymous basis.

Reported matters that suggest substantial violations of compliance policies or applicable Federal health care program requirements should be documented and investigated promptly to determine their veracity and the scope and cause of any underlying problem. The compliance officer should maintain a detailed log that records such reports, including the nature of any investigation, its results, and any remedial or disciplinary action taken. Such information, redacted of individual identifiers, should be summarized and included in reports to the board of directors, the president or CEO, and compliance committee. Although the pharmaceutical manufacturer should always strive to maintain the confidentiality of an employee's identity, it should also make clear that there may be a point where the individual's identity may become known or need to be revealed in certain instances. The OIG recognizes that protecting anonymity may be infeasible for small companies. However, the OIG believes all employees, when seeking answers to questions or reporting potential instances of fraud and abuse, should know to whom to turn for a meaningful response and should be able to do so without fear of retribution.

An effective compliance program should incorporate thorough monitoring of its implementation and an ongoing evaluation process. The compliance officer should document this ongoing monitoring, including reports of suspected noncompliance, and provide these assessments to company's senior management and the compliance committee. The extent and frequency of the compliance audits may vary depending on variables such as the pharmaceutical manufacturer's available resources, prior history of noncompliance, and the risk factors particular to the company. The nature of the reviews may also vary and could include a prospective systemic review of the manufacturer's processes, protocols, and practices or a retrospective review of actual practices in a particular area.

Although many assessment techniques are available, it is often effective to have internal or external evaluators who have relevant expertise perform regular compliance reviews. The reviews should focus on those divisions or departments of the pharmaceutical manufacturer that have substantive involvement with or impact on Federal health care programs (such as the government contracts and sales and marketing divisions) and on the risk areas identified in this guidance. The reviews should also evaluate the company's policies and procedures regarding other areas of concern identified by the OIG ( e.g. , through Special Fraud Alerts) and Federal and state law enforcement agencies. Specifically, the reviews should evaluate whether: (1) The pharmaceutical manufacturer has policies covering the identified risk areas; (2) whether the policies were implemented and communicated; and (3) whether the policies were followed.

An effective compliance program should include clear and specific disciplinary policies that set out the consequences of violating the law or the pharmaceutical manufacturer's code of conduct or policies and procedures. A pharmaceutical manufacturer should consistently undertake appropriate disciplinary action across the company in order for the disciplinary policy to have the required deterrent effect. Intentional and material noncompliance should subject transgressors to significant sanctions. Such sanctions could range from oral warnings to suspension, termination or other sanctions, as appropriate. Disciplinary action also may be appropriate where a responsible employee's failure to detect a violation is attributable to his or her negligence or reckless conduct. Each situation must be considered on a case-by-case basis, taking into account all relevant factors, to determine the appropriate response.

Violation of a pharmaceutical manufacturer's compliance program, failure to comply with applicable Federal or state law, and other types of misconduct threaten the company's status as a reliable, honest, and trustworthy participant in the health care industry. Detected but uncorrected misconduct can endanger the reputation and legal status of the company. Consequently, upon receipt of reasonable indications of suspected noncompliance, it is important that the compliance officer or other management officials immediately investigate the allegations to determine whether a material violation of applicable law or the requirements of the compliance program has occurred and, if so, take decisive steps to correct the problem. 14 The exact nature and level of thoroughness of the investigation will vary according to the circumstances, but the review should be detailed enough to identify the root cause of the problem. As appropriate, the investigation may include a corrective action plan, a report and repayment to the government, and/or a referral to criminal and/or civil law enforcement authorities.

Where the compliance officer, compliance committee, or a member of senior management discovers credible evidence of misconduct from any source and, after a reasonable inquiry, believes that the misconduct may violate criminal, civil, or administrative law, the company should promptly report the existence of misconduct to the appropriate Federal and state authorities  15 within a reasonable period, but not more than 60 days, 16 after determining that there is credible evidence of a violation. 17 Prompt voluntary reporting will demonstrate the pharmaceutical manufacturer's good faith and willingness to work with governmental authorities to correct and remedy the problem. In addition, reporting such conduct will be considered a mitigating factor by the OIG in determining administrative sanctions ( e.g. , penalties, assessments, and exclusion), if the reporting company becomes the subject of an OIG investigation. 18

When reporting to the government, a pharmaceutical manufacturer should provide all information relevant to the alleged violation of applicable Federal or state law(s) and the potential financial or other impact of the alleged violation. The compliance officer, under advice of counsel and with guidance from the governmental authorities, could be requested to continue to investigate the reported violation. Once the investigation is completed, and especially if the investigation ultimately reveals that criminal, civil or administrative violations have occurred, the compliance officer should notify the appropriate governmental authority of the outcome of the investigation, including a description of the impact of the alleged violation on the operation of the applicable Federal health care programs or their beneficiaries.

In today's environment of increased scrutiny of corporate conduct and increasingly large expenditures for prescription drugs, it is imperative for pharmaceutical manufacturers to establish and maintain effective compliance programs. These programs should foster a culture of compliance that begins at the executive level and permeates throughout the organization. This compliance guidance is designed to provide assistance to all pharmaceutical manufacturers as they either implement compliance programs or re-assess existing programs. The essential elements outlined in this compliance guidance can be adapted to the unique environment of each manufacturer. It is the hope and expectation of the OIG that the resulting compliance programs will benefit not only Federal health care programs and their beneficiaries, but also pharmaceutical manufacturers themselves.

Mandatory Guidelines for Federal Workplace Drug Testing were developed in accordance with Executive Order 12564 and section 503 of Pub. L. 100-71. Subpart C of the Guidelines, “Certification of Laboratories Engaged in Urine Drug Testing for Federal Agencies,” sets strict standards which laboratories must meet in order to conduct urine drug testing for Federal agencies. To become certified an applicant laboratory must undergo three rounds of performance testing plus an on-site inspection.

To maintain that certification a laboratory must participate in a quarterly performance testing program plus periodic, on-site inspections.

Laboratories which claim to be in the applicant stage of certification are not to be considered as meeting the minimum requirements expressed in the HHS Guidelines. A laboratory must have its letter of certification from SAMHSA, HHS (formerly: HHS/NIDA) which attests that it has met minimum standards.

In accordance with Subpart C of the Guidelines, the following laboratories meet the minimum standards set forth in the Guidelines:

On August 30, 2002, HUD published a notice (67 FR 55861) that announced the availability of the revised Public Housing Occupancy Guidebook (Occupancy Guidebook) on HUD's website for review and comment. In view of the widespread use of the Occupancy Guidebook and its importance to public housing residents and PHA staff, HUD has decided to further extend the comment period until October 15, 2002 so that all stakeholders will have a greater opportunity to participate and express their viewpoints.

Copies of HUD's draft, revised Occupancy Guidebook will be available until October 15, 2002 at the HUD web site http://www.hud.gov/offices/pih. Members of the public without access to the World Wide Web may obtain a copy of the revised Occupancy Guidebook by contacting the Public and Indian Housing Resource Center at 1-800-955-2232.

Public input is solicited on the overall scope and direction of the revised Occupancy Guidebook. Interested members of the public may submit comments, or submit additional comments, either electronically or by overnight mail to the addresses listed in the Addresses section above. To be most helpful, comments must be identified by specific page and paragraph references and must be received by October 15, 2002.

Applicant requests an amendment to an existing permit to allow collection of seeds and vouchers of Canelo Hills ladies'-tresses ( Spiranthes delitescens ) from Santa Cruz County, Arizona.

Applicant requests a permit for research and recovery purposes to conduct presence/absence surveys for the following species: lesser long-nosed bat ( Leptonycteris curasoae yerbabuenae ), southwestern willow flycatcher ( Empidonax traillii extimus ), and cactus ferruginous pygmy owl ( Glaucidium brasilianum cactorum ). All surveys are to occur throughout the known range of each species, including locations within the states of Arizona, California, Colorado, New Mexico, Texas, and Utah. Applicant additionally requests authorization to conduct surveys for and transplant individuals of Pima pineapple cactus ( Coryphantha scheeri var. robustispina ) within Pima County, Arizona.

Applicant requests an amendment to an existing permit to allow presence/absence surveys for American burying beetle ( Nicrophorus americanus ) within Arkansas.

Applicant requests an amendment to an existing permit to allow presence/absence surveys for southwestern willow flycatcher ( Empidonax traillii extimus ) within Arizona.

Applicant requests an amendment to an existing permit to allow collection of the following species from within Texas: Big Bend gambusia ( Gambusia gaigei ), Clear Creek gambusia ( Gambusia heterochir ), and Pecos gambusia ( Gambusia nobilis ).

Applicant requests a permit for research and recovery purposes to allow collection and habitat manipulation of Pima pineapple cactus ( Coryphantha scheeri var. robustispina ) within Pima and Santa Cruz Counties, Arizona.

Applicant requests a permit for research and recovery purposes to conduct presence/absence surveys and salvage the following species where they are known to occur throughout Arizona, New Mexico, and Texas: lesser long-nosed bat ( Leptonycteris curasoae yerbabuenae ), Mexican long-nosed bat ( Leptonycteris nivalis ), black-footed ferret ( Mustela nigripes ), Hualapai Mexican vole ( Microtus mexicanus hualpaiensis ), southwestern willow flycatcher ( Empidonax traillii extimus ), black-capped vireo ( Vireo atricapillus ), golden-cheeked warbler ( Dendroica chrysoparia ), cactus ferruginous pygmy owl ( Glaucidium brasilianum cactorum ), Yuma clapper rail ( Rallus longirostris yumanensis ), Sonoran tiger salamander ( Ambystoma tigrinum stebbinsi ), desert pupfish ( Cyprinodon macularius ), Gila topminnow ( Poeciliopsis occidentalis ), humpback chub ( Gila cypha ), razorback sucker ( Xyrauchen texanus ), Virgin River chub ( Gila robusta semidnuda ), and woundfin ( Plagopterus argentissimus ).

Applicant requests an amendment to an existing permit to allow authorization to house and care for captive bred jaguarundi ( Herpailurus yagouaroundi ) within Jim Wells County, Texas.

Applicant requests an amendment to an existing permit to allow presence/absence surveys and collection of the following species within Texas: Rhadine exilis (ground beetle, no common name), Rhadine infernalis (ground beetle, no common name), Batrisodes venyivi (Helotes mold beetle), Texella cokendolpheri (Cokendolpher cave harvestman), Cicurina baronia (Robber Baron cave meshweaver), Cicurina madla (Madla's cave meshweaver), Cicurina venii (Bracken Bat Cave meshweaver), Cicurina vespera (Government Canyon Bat Cave meshweaver), and Neoleptoneta microps (Government Canyon Bat Cave spider).

Applicant requests an amendment to an existing permit to allow presence/ absence surveys for brown pelican ( Pelecanus occidentalis ) within Texas.

There were both supporters and opponents to the proposal to create a new national wildlife refuge in south central Ohio, but the community consistently expressed support for the conservation of agricultural and natural resource areas. In withdrawing the proposal to establish a refuge, the Service is supporting interest in locally-driven conservation efforts. The Final Report includes an overview of the refuge proposal, a brief history of the area, description of the natural resource values of the Little Darby Creek Watershed, information on local perceptions and expectations related to conservation, and information on resources available for local conservation initiatives. The Report reiterates the Service's belief in preserving the watershed's resource values.

OMB issued guidelines on January 3, 2002 (67 FR 369-378), as corrected and reprinted on February 22, 2002 (67 FR 8451-8460), to implement Section 151 of the Treasury and General Government Appropriations Act for FY 2001 (Public Law 106-554, HR 5658). Section 515 and the OMB Guidelines require each federal agency subject to the Paperwork Reduction Act to issue its own guidelines that provide policies and procedures used by the Agency to ensure the objectivity, utility, and integrity of information disseminated by the Agency. The guidelines must also establish administrative mechanisms allowing affected persons to obtain correction of information disseminated to the public that does not comply with OMB and Agency guidelines. The Peace Corps published proposed guidelines in the Federal Register on August 21, 2002, and requested public comment on the guidelines. See 67 FR 54329. the Agency received no comments from the public. The Agency did receive comments and guidance from OMB that have been integrated into the final guidelines. The guidelines may be accessed on the Agency's public Web site at http://www.peacecorps.gov or by written request addressed to Suzanne B. Glasow, Office of the General Counsel, 1111 20th Street, NW., Washington DC 20526.

On February 18, 2000, pursuant to section 203 of the Trade Act of 1974, as amended (the “Trade Act”) (19 U.S.C. 2253), the President issued Proclamation 7274, which imposed additional duties on certain circular welded carbon quality line pipe (“line pipe”) provided for in subheadings 7306.10.10 and 7306.10.50 of the HTS. On July 29, 2002, the United States Trade Representative (“USTR”) negotiated an agreement with the Republic of Korea limiting the export from Korea and import into the United States of line pipe through the implementation of a tariff-rate quota, to take effect on September 1, 2002. Proclamation 7585 of August 28, 2002, revised the additional duties on line pipe from Korea, replacing them with a tariff-rate quota in the terms provided for under the agreement with Korea. Effective with respect to goods entered, or withdrawn from warehouse for consumption, on or after September 1, 2002, and prior to the close of March 1, 2003, Proclamation 7585 modified subchapter III of chapter 99 of the HTS so as to provide for such tariff-rate quota.

Technical errors introduced through the annex to Proclamation 7585 have come to the attention of USTR. The annex to this notice makes technical corrections to the HTS to remedy these errors. In particular, the annex to this notice corrects errors in the tariff subheadings created by the Annex to Proclamation 7585 and the amount of the tariff-rate quota.

Proclamation 6969 authorized the USTR to exercise the authority provided to the President under section 604 of the Trade Act of 1974 (19 U.S.C. 2483) to embody rectifications, technical or conforming changes, or similar modifications in the HTS. Under authority vested in the USTR by Proclamation 6969, the rectifications, technical and conforming changes, and similar modifications set forth in the annex to this notice shall be embodied in the HTS with respect to goods entered, or withdrawn from warehouse for consumption, on or after the date set forth in each item in the Annex to this notice.

On November 5, 1973, the National Highway Traffic Safety Administration (NHTSA) published the Standards for Devices to Measure Breath Alcohol (38 FR 30459). A Qualified Products List of Evidential Breath Measurement Devices comprised of instruments that met this standard was first issued on November 21, 1974 (39 FR 41399).

On December 14, 1984 (49 FR 48854), NHTSA converted this standard to Model Specifications for Evidential Breath Testing Devices, and published a Conforming Products List (CPL) of instruments that were found to conform to the Model Specifications as Appendix D to that notice (49 FR 48864).

On September 17, 1993, NHTSA published a notice (58 FR 48705) to amend the Model Specifications. The notice changed the alcohol concentration levels at which instruments are evaluated, from 0.000, 0.050, 0.101, and 0.151 BAC, to 0.000, 0.020, 0.040, 0.080, and 0.160 BAC; added a test for the presence of acetone; and expanded the definition of alcohol to include other low molecular weight alcohols including methyl or isopropyl. On July 21, 2000, the most recent amendment to the Conforming Products List (CPL) was published (65 FR 45419), identifying those instruments found to conform with the Model Specifications.

Since the last publication of the CPL, seven (7) instruments have been evaluated and found to meet the model specifications, as amended on September 17, 1993, for mobile and non-mobile use. In alphabetical order by company, they are: (1) Alert J4X.ec manufactured by Alcohol Countermeasure Systems, Inc. of Mississauga, Ontario, Canada. This is a hand held device that uses a fuel cell sensor and is powered by an internal battery. (2) Intoxilyzer 8000 manufactured by CMI, Inc. of Owensboro, KY. This is a non-dispersive infrared device which uses the 3.4 micron and the 9 micron band for measurement of alcohol. It is powered by 120 volts AC power or by 12 volts DC power from a car battery. (3) Intoxilyzer S-D5 manufactured by CMI, Inc. of Owensboro, KY. This device is a hand-held device that uses a fuel cell sensor. (4) The new Alco-Sensor III with serial numbers above 1,200,000. This is an enhanced version of the earlier Alco-Sensor III. The enhanced version has a new fuel cell and a microprocessor that improves performance. It is a hand held device intended for stationary or roadside operations. As indicated, it uses a fuel cell sensor and is powered by an internal battery. (5) The Intox EC/IR 2 manufactured by Intoximeters, Inc. of St. Louis, Missouri. This is a bench top device intended primarily for use in stationary operations. It uses a fuel cell sensor and can be powered by either 110 volts AC or 9 volts DC power sources. (6) The FC 10, manufactured by Lifeloc Technologies, Inc. of Wheat Ridge, CO. This is a handheld device that uses a fuel cell sensor. (7) The FC 20, also manufactured by Lifeloc Technologies, Inc. of Wheat Ridge, CO. This is also a handheld device that uses a fuel cell sensor. The Lifeloc FC 20 is similar to the FC 10 except that it has additional features that are not addressed by the model specifications.

Finally, three devices are being removed from the CPL, because they are no longer manufactured and are no longer in use. They are: (1) Alco.Tector Model 500, manufactured by Decator Electronics of Decator, Illinois. This device was introduced more than 30 years ago. It has not been manufactured for at least 20 years, and its manufacturer is no longer in existence. It would be impossible to repair because replacement parts are not available. The agency has no knowledge of any such devices in use. (2) The AE-D1 manufactured by Lion Laboratories, Ltd. of Cardiff, Wales, UK. The manufacturer has confirmed in writing that this unit is totally obsolete, no longer in use and no longer in production. (3) The Auto-Alcolmeter manufactured by Lion Laboratories, Ltd. of Cardiff, Wales, UK. The manufacturer has also confirmed in writing that this unit is totally obsolete, no longer in use and no longer in production.

The CPL has been amended to add the seven instruments identified above to the list, and to remove the three instruments also identified above.

In accordance with the foregoing, the CPL is therefore amended, as set forth below.