The purpose of the Committee is to advise the Joint Board on examinations in actuarial mathematics and methodology. The Joint Board administers such examinations in discharging its statutory mandate to enroll individuals who wish to perform actuarial services with respect to pension plans subject to the Employee Retirement Income Security Act of 1974. The Committee's advisory functions will include, but will not necessarily be limited to: (1) Considering areas of actuarial knowledge that should be treated on the examinations; (2) developing examination questions; (3) recommending proposed examinations and pass marks; and (4), as requested by the Joint Board, making recommendations relative to the examination program.

Unless otherwise indicated, all citations to the statute are references to the provisions effective January 1, 1995, the effective date of the amendments made to the Tariff Act of 1930 (the Act) by the Uruguay Round Agreements Act. In addition, unless otherwise indicated, all citations to the Department's regulations are to the regulations as codified at 19 CFR Part 351 (1999).

On August 31, 2000, the Department received a timely request from Hyundai Pipe Co., Ltd. (“HDP”) in accordance with 19 CFR 351.214(d), for a new shipper review of the antidumping duty order on certain cold-rolled carbon steel flat products from Korea, which has an August anniversary date. See Antidumping Duty Order: Certain Cold-Rolled Carbon Steel Flat Products from Korea, 58 FR 44159 (August 19, 1993).

In its request of August 31, 2000, HDP, as required by 19 CFR 351.214(b)(2)(i) and (b)(2)(iii)(A), certified that it did not export the subject merchandise to the United States during the period of investigation (“POI”) January 1, 1992 through June 30, 1992, and that since the investigation was initiated on July 20, 1992, (57 FR 33488, July 29, 1992), it has not been affiliated with any company which exported the subject merchandise to the United States during the POI. Pursuant to the Department's regulations at 19 CFR 351.214(b)(2)(iv), HDP submitted documentation establishing the date on which it first entered the subject merchandise to the United States, the volume of that first shipment, and the date of its first sale to an unaffiliated customer in the United States.

In accordance with section 751(a)(2)(B) of the Act and 19 CFR 351.214(d), we are initiating a new shipper review of the antidumping order on cold-rolled steel from Korea. In accordance with 19 CFR 351.214(h)(1), we intend to issue preliminary results of this review no later than 180 days after the date of initiation.

In accordance with section 351.214(g)(1)(i)(A) of the Department's regulations, the period of review (“POR”) for a new shipper review initiated in the month immediately following the annual anniversary month is the twelve-month period preceding the anniversary month. Therefore, the POR for this new shipper is August 1, 1999 through July 31, 2000.

Concurrent with publication of this notice and in accordance with 19 CFR 351.214(e), we will instruct the U.S. Customs Service to allow, at the option of the importer, the posting of a bond or security in lieu of a cash deposit for each entry of the merchandise exported by the above listed company, until the completion of this review.

The interested parties must submit applications for disclosure under administrative protective order in accordance with 19 CFR 351.305 and 351.306.

This initiation and notice are in accordance with section 751(a) of the Act (19 U.S.C. 1675(a)) and 19 CFR 351.214.

In section 135 of the 1974 Trade Act, as amended (19 U.S.C. 2155), Congress established a private-sector advisory system to ensure that U.S. trade policy and trade negotiation objectives adequately reflect U.S. commercial and economic interests. Section 135(a)(1) of the 1974 Trade Act directs the President to “seek information and advice from representative elements of the private sector and the non-Federal governmental sector with respect to:

(A) Negotiating objectives and bargaining positions before entering into a trade agreement under [title I of the 1974 Trade Act and section 1102 of the Omnibus Trade and Competitiveness Act of 1988];

(B) The operation of any trade agreement once entered into; including preparation for dispute settlement panel proceedings to which the United States is a party; and

(C) Other matters arising in connection with the development, implementation, and administration of the trade policy of the United States. * * *”

Section 135(c)(2) of the 1974 Trade Act provides:

(2) The President shall establish such sectoral or functional advisory committees as may be appropriate. Such committees shall, insofar as is practicable, be representative of all industry, labor, agricultural, or service interests (including small business interests) in the sector or functional areas concerned. In organizing such committees, the United States Trade Representative and the Secretaries of Commerce, Labor, Agriculture, the Treasury, or other executive departments, as appropriate, shall:

(A) Consult with interested private organizations; and

(B) Take into account such factors as—

(i) Patterns of actual and potential competition between United States industry and agriculture and foreign enterprise in international trade,

(ii) The character of the nontariff barriers and other distortions affecting such competition,

(iii) The necessity for reasonable limits on the number of such advisory committees,

(iv) The necessity that each committee be reasonably limited in size, and

(v) In the case of each sectoral committee, that the product lines covered by each committee be reasonably related.

Pursuant to this provision, Commerce and USTR have established and co-chair seventeen Industry Sector Advisory Committees (ISACs) and four Industry Functional Advisory Committees (IFACs). The Committees' efforts have resulted in strengthening U.S. negotiating positions by enabling the United States to display a united front when it negotiates trade agreements with other nations. Committees meet an average of four times a year in Washington, D.C. Members serve without compensation and are responsible for all expenses incurred in attending Committee meetings. For additional information regarding the functions and membership of these committees, and general qualifications for membership, see 64 FR 10448-10449, March 4, 1999 (Volume 64, Number 42).

Eligibility to serve as an environmental representative on ISAC 10 is limited to U.S. citizens who are not full-time employees of a governmental entity, who represent a “U.S. entity”, and who are not registered with the Department of Justice under the Foreign Agents Registration Act. For purposes of the preceding sentence, a “U.S. entity” is an organization incorporated in the United States (or, if unincorporated, having its headquarters in the United States):

(1) That is controlled by U.S. citizens or by another U.S. entity. An entity is not a U.S. entity if more than 50 percent of its Board of Directors or membership is made up of non-U.S. citizens. If the nominee is to represent an organization more than 10 percent of whose Board of Directors or membership is made up of non-U.S. citizens, or non-U.S. entities, the nominee must demonstrate at the time of nomination that this non-U.S. interest does not constitute control and will not adversely affect his or her ability to serve as a trade advisor to the United States; and

(2) at least 50 percent of whose annual revenue is attributable to non-governmental, U.S. sources.

USTR and Commerce will select environmental representatives eligible for appointment to ISAC 10 based upon the following:

(1) The organization to be represented will be considered based on environmental interest in trade policies in the sector relevant to the work of the Committee; and

(2) The nominee should demonstrate special interest in and knowledge of the formulation of environmental policies in the sector relevant to the work of the Committee, and the ability to work with governmental officials and industry representatives to reach consensus on complex environmental and trade issues affecting the relevant industry sectors.

(3) Preference will be accorded nominees who also demonstrate knowledge of and familiarity with the relevant industry sectors, as well as with international trade matters, including trade policy development relevant to those sectors.

Environmental representatives, as members of the Committee, will be required to have a security clearance. Members serve without compensation and are responsible for all expenses incurred in attending committee meetings.

Requests for applications should be sent to the Director of the Industry Consultations Program, U.S. Department of Commerce, 14th and Constitution Avenue, NW, Room 2015-B, Washington, D.C. 20230. This notice is issued under the Federal Advisory Committee Act (5 U.S.C., app. 2) and 21 CFR part 14 relating to advisory committees.

Location: Sheraton Ferncroft, 50 Ferncroft Road, Danvers, MA 01923; telephone: (978) 777-2500.

The Groundfish Oversight Committee will continue its development of management alternatives for Amendment 13 to the Northeast Multispecies Fishery Management Plan. The Committee will consider comments from it’s Advisory Panel on the area management and sector allocation proposals and may make changes to those proposals based on the comments received. They will finalize recommendations for rebuilding plans for overfished stocks, measures to address capacity in the groundfish fishery, and recommendations for closed areas. In addition, the Committee will refine its proposals for a revised status quo, area management, and sector allocation alternatives. They will review access by other fisheries or gears to closed areas and may develop recommendations for changes to those vessels and gears that are currently allowed access to closed areas. They will also develop priorities for cooperative research proposals that will be forwarded to the Research Steering Committee. The Committee will meet in a closed session to review advisory panel applications.

Location: Radisson Airport Hotel, 2081 Post Road, Warwick, RI 02886; telephone: (401)739-3000.

The Panel will discuss monkfish trip limit options to address perceived inequities across fleet sectors and develop recommendations to the Monkfish Committee. It will also develop a statement of purpose and a range of alternatives for monkfish spawning area/time management, and will discuss possible options for bycatch control and minimizing discards of monkfish in small mesh fisheries.

Location: Sheraton Colonial, One Audubon Road, Wakefield, MA 01880; telephone: (781) 245-9300.

The Research Committee will discuss priorities for funding regional research projects in 2001.

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

These meetings are physically accessible to people with disabilities. Requests for sign language interpretation or other auxiliary aids should be directed to Paul J. Howard (see ADDRESSES ) at least five days prior to the meeting dates.

Issuance of permits and permit modifications, as required by the Endangered Species Act of 1973 (16 U.S.C. 1531-1543) (ESA), is based on a finding that such permits/modifications: (1) are applied for in good faith; (2) would not operate to the disadvantage of the listed species which are the subject of the permits; and (3) are consistent with the purposes and policies set forth in section 2 of the ESA. Authority to take listed species is subject to conditions set forth in the permits. Permits and modifications are issued in accordance with and are subject to the ESA and NMFS regulations governing listed fish and wildlife permits (50 CFR parts 222-226).

Those individuals requesting a hearing on an application listed in this notice should set out the specific reasons why a hearing on that application would be appropriate (see ADDRESSES ). The holding of such hearing is at the discretion of the Assistant Administrator for Fisheries, NOAA. All statements and opinions contained in the permit action summaries are those of the applicant and do not necessarily reflect the views of NMFS.

The following species are covered in this notice:

Green turtle ( Chelonia mydas) , Hawksbill turtle ( Eretmochelys imbricata ), Kemp's ridley turtle ( Lepidochelys kempii ), Leatherback turtle (Dermochelys coriacea), Loggerhead turtle ( Caretta caretta ).

Shortnose sturgeon ( Acipenser brevirostrum ).

Notice was published on May 23, 2000 (65 FR 34445) that Mr. Carlos E. Diez, of Department of Natural and Environmental Resources applied for a scientific research permit (1253). The purpose of the research is to provide information on the ecology and population dynamics of the hawksbill and green turtles that inhabit the waters surrounding Puerto Rico and its adjacent islands (Mona, Monito, Desecheo, Caja-de-Muertos, Viques and Culebra). This research will improve the effectiveness of management efforts by addressing priorities set forth in the recovery plans for both species: (1) identification of important marine habitats; (2) determination of adult and juvenile distribution and abundance; (3) determination of sex ratios in the juvenile population; (4) evaluation of the extent of ingestion of persistent marine debris; (5) determination of growth rates and age at sexual maturity, and (6) quantification of threats to adults and juveniles on foraging grounds. Permit 1253 was issued on September 22, 2000, authorizing take of listed species. Permit 1253 expires July 31, 2005.

Notice was published on April 14, 2000 (65 FR 20138) that the Southwest Region, NMFS applied for a modification to 1190. Modification #1 authorizes and increase in the annual take of olive ridley turtles from 10 to 25. The purpose of the research is to document and evaluate the incidental take of pelagic turtles by the longline fishery, to help estimate the impact of the fishery on listed turtles as individuals and as populations, and to determine methods to reduce that impact. Research will evaluate how incidental captures affect sea turtle anatomy and physiology as a function of season, location of take, water temperature, species, size, time of day, and gear configuration. The results of the research will help NMFS to better meet the goals and objectives of the Pacific Sea Turtle Recovery Plans, the Hooking Mortality Workshop, and the requirements of Section 7 Biological Opinions developed for this fishery, and ultimately, to fulfill ESA responsibilities to protect, conserve, and recover listed species.

Incidentally-captured turtles will be examined, tagged, weighed, measured, resuscitated using approved techniques, have tissue samples taken, and be released. Some of these turtles will have transmitters attached. Dead turtles will be removed from the marine environment for research purposes, including necropsy and collection of life history data. Tissue samples may be used lab studies including the following: toxicology, histopathology, and genetic studies to identify nesting origins of incidentally taken turtles. Modification #1 to Permit 1190 was issued on September 21, 2000, authorizing take of listed species. Permit 1190 expires March 31, 2004.

The Department of the Army systems of records notices subject to the Privacy Act of 1974 (5 U.S.C. 552a), as amended, have been published in the Federal Register and are available from the address above.

The specific changes to the record system being amended are set forth below followed by the notice, as amended, published in its entirety.

The proposed amendments are not within the purview of subsection (r) of the Privacy Act of 1974 (5 U.S.C. 552a), as amended, which requires the submission of new a or altered system report.

The Department of the Navy's record system notices for records systems subject to the Privacy Act of 1974 (5 U.S.C. 552a), as amended, have been published in the Federal Register and are available from the address above.

The Department of the Navy proposes to delete two systems of records notices in its inventory of record systems subject to the Privacy Act of 1974 (5 U.S.C. 552a), as amended. The deletions are not within the purview of subsection (r) of the Privacy Act of 1974 (5 U.S.C. 552a), as amended, which requires the submission of a new or altered system report.

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

The Department of Education is especially interested in public comment addressing the following issues: (1) Is this collection necessary to the proper functions of the Department; (2) will this information be processed and used in a timely manner; (3) is the estimate of burden accurate; (4) how might the Department enhance the quality, utility, and clarity of the information to be collected; and (5) how might the Department minimize the burden of this collection on the respondents, including through the use of information technology.

Type of Review: Extension.

Title: Annual Client Assistance Program (CAP) Report.

Frequency: Annually.

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

Reporting and Recordkeeping Hour Burden: Responses: 56; burden hours: 350.

Abstract: Form RSA-227 is used to analyze and evaluate the Client Assistance Program (CAP) administered by designated CAP agencies. These agencies provide services to clients and client applicants of programs, projects, and community rehabilitation programs authorized by the Rehabilitation Act of 1973, as amended. Data also are reported on information and referral services provided to any individual with a disability.

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

Comments regarding burden and/or the collection activity requirements should be directed to Sheila Carey at (202) 708-6287 or via her internet address Sheila_Carey@ed.gov. Individuals who use a telecommunications device for the deaf (TDD) may call the Federal Information Relay Service (FIRS) at 1-800-877-8339.

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

The Department of Education is especially interested in public comment addressing the following issues: (1) Is this collection necessary to the proper functions of the Department; (2) will this information be processed and used in a timely manner; (3) is the estimate of burden accurate; (4) how might the Department enhance the quality, utility, and clarity of the information to be collected; and (5) how might the Department minimize the burden of this collection on the respondents, including through the use of information technology.

Type of Review: New.

Title: America's Career Resource Network State Grant Annual Performance Report.

Frequency: Annually.

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

Reporting and Recordkeeping Hour Burden: Responses: 56; burden hours: 9,408.

Abstract: Section 118(e) of the Carl D. Perkins Vocational and Technical Education Act requires the Department of Education to report annually to Congress concerning activities carried out by States with grant funds awarded under section 118. This collection solicits information from grantees necessary to fulfill this requirement, as well as to support the Department's monitoring and technical assistance activities.

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

Comments regarding burden and/or the collection activity requirements should be directed to Sheila_Carey at (202) 708-6287 or via her internet address Sheila_Carey@ed.gov. Individuals who use a telecommunications device for the deaf (TDD) may call the Federal Information Relay Service (FIRS) at 1-800-877-8339.

Section 3506 of the Paperwork

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

The Department of Education is especially interested in public comment addressing the following issues: (1) Is this collection necessary to the proper functions of the Department; (2) will this information be processed and used in a timely manner; (3) is the estimate of burden accurate; (4) how might the Department enhance the quality, utility, and clarity of the information to be collected; and (5) how might the Department minimize the burden of this collection on the respondents, including through the use of information technology.

Type of Review: New.

Title: Education Longitudinal Study of 2002 (ELS 2002).

Frequency: Annually.

Affected Public: Not-for-profit institutions; State, Local, or Tribal Gov't, SEAs or LEAs.

Reporting and Recordkeeping Hour Burden: Responses: 51,597; burden hours: 59,497.

Abstract: Year 2001 field test will include 50 schools in five states, students, parents, teachers, and librarians. The main study in Spring 2002 in all 50 states and District of Columbia will constitute the baseline of a longitudinal study of school effectiveness and impact on postsecondary and labor market outcomes.

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

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

The purpose of the Secretary of Energy Advisory Board (The Board) is to provide the Secretary of Energy with essential independent advice and recommendations on issues of national importance. The Board and its subcommittees provide timely, balanced, and authoritative advice to the Secretary of Energy on the Department's management reforms, research, development and technology activities, energy and national security responsibilities, environmental cleanup activities, and economic issues relating to energy.

The agenda for the October 10th meeting has not been finalized. However, the meeting will include a series of briefings and discussions on Department of Energy, Board and subcommittee activities including the Laboratory Operations Board, Openness Advisory Panel, Panel on Emerging Technological Alternatives to Incineration, NIF Laser System Task Force, and the Task Force on DOE Nonproliferation Programs with Russia. Members of the Public wishing to comment on issues before the Secretary of Energy Advisory Board will have an opportunity to address the Board during the afternoon period for public comment. The final agenda will be available at the meeting.

In keeping with procedures, members of the public are welcome to observe the business of the Secretary of Energy Advisory Board and submit written comments or comment during the scheduled public comment period. The Chairman of the Board is empowered to conduct the meeting in a fashion that will, in the Chairman's judgment, facilitate the orderly conduct of business. During its meeting in Denver, Colorado, the Board welcomes public comment. Members of the public will be heard in the order in which they sign up at the beginning of the meeting. The Board will make every effort to hear the views of all interested parties. You may submit written comments to Mary Louise Wagner, Executive Director, Secretary of Energy Advisory Board, AB-1, U.S. Department of Energy, 1000 Independence Avenue, SW, Washington, DC 20585. This notice is being published less than 15 days before the date of the meeting due to the late resolution of programmatic issues.

A copy of the minutes and a transcript of the meeting will be made available for public review and copying approximately 30 days following the meeting at the Freedom of Information Public Reading Room, 1E-190 Forrestal Building, 1000 Independence Avenue, SW., Washington, DC between 9 a.m. and 4 p.m., Monday through Friday except Federal holidays. Further information on the Secretary of Energy Advisory Board and its subcommittees may be found at the Board's web site, located at http://www.hr.doe.gov/seab.

Title: The 2001 Hazardous Waste Report (Biennial Report), EPA ICR Number 0976.10; OMB Control Number 2050-0024. This is a request for an extension of a currently approved collection.

Abstract: Large quantity generators of hazardous waste and owners/operators of hazardous waste facilities must complete, under the authority of RCRA sections 3002 and 3004, a report every other year on the amount of waste they generate and how it was managed. EPA uses the information to understand waste management practices, to expand its database of information for rulemakings, and to monitor compliance with regulatory requirements.

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 Notice required under 5 CFR 1320.8(d), soliciting comments on this collection of information was published June 23, 2000 (65 FR 39142). We are implementing all of the recommendations described in the June 23, 2000 notice. Nine comments were received on the June Notice, including a comment from the Tribal Association on Solid Waste and Emergency Response (TASWER). TASWER asked that a data element be added to the Biennial Report that would identify RCRA facilities on or adjacent to Indian Country and Alaska Native Villages. We have begun discussions with TASWER to see how their information needs might be met by the Biennial Report or other means. However, this process cannot be completed in time to make changes to the 2001 Biennial Report.

Burden Statement: The annual public reporting and recordkeeping burden for this collection of information is estimated to average 19.49 hours per response. Burden means the total time, effort, or financial resources expended by persons to generate, maintain, retain, or disclose or provide information to or for a Federal agency. This includes the time needed to review instructions; develop, acquire, install, and utilize technology and systems for the purposes of collecting, validating, and verifying information, processing and maintaining information, and disclosing and providing information; adjust the existing ways to comply with any previously applicable instructions and requirements; train personnel to be able to respond to a collection of information; search data sources; complete and review the collection of information; and transmit or otherwise disclose the information.

Respondents/Affected Entities: Large Quantity Generators and Treatment, Storage, and Disposal Facilities.

Estimated Number of Respondents: 10,157.

Frequency of Response: Biennially.

Estimated Total Annual Hour Burden: 195,214 hours.

Estimated Total Annualized Capital, O&M Cost Burden: $26,000.

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 following addresses listed above.

Please refer to EPA ICR No. 0976.10 and OMB Control No. 2050-0024 in any correspondence.

Title: Hazardous Waste Specific Unit Requirements, and Special Waste Processes and Types (OMB Control No. 2050-0050; EPA ICR No. 1572.05) expiring December 31, 2000. This is a request for extension of a currently approved collection.

Abstract: This ICR provides a discussion of all of the information collection requirements associated with specific unit standards applicable to owners and operators of facilities that treat, store, or dispose of hazardous wastes as defined by 40 CFR part 261. It includes a detailed description of the data items and respondent activities associated with each requirement and with each hazardous waste management unit at a facility. The specific units and processes included in this ICR are: Tank Systems, Surface Impoundments, Waste Piles, Land Treatment, Landfills, Incinerators, Thermal Treatment, Chemical/Physical, and Biological Treatment, Miscellaneous (subpart X), Drip Pads, Process Vents, Equipment Leaks, Containment Buildings, Recovery/Recycling.

With each information collection covered in this ICR, EPA is aiding the goal of complying with its statutory mandate under RCRA to develop standards for hazardous waste treatment, storage, and disposal facilities, to protect human health and the environment. Without the information collection, the agency cannot assure that the facilities are designed and operated properly.

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 May 5, 2000 (65 FR 26196); no comments were received.

Burden Statement: The annual public reporting and recordkeeping burden for this collection of information is estimated to average the following burden hours per response:

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

Respondents/Affected Entities: Business.

Estimated Number of Respondents: 6,341.

Frequency of Response: Occasional.

Estimated Total Annual Hour Burden: 287,069 hours.

Estimated Total Annualized Capital, Operating/ Maintenance Cost Burden: $874,517.

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 addresses listed above. Please refer to EPA ICR No. 1572.05 and OMB Control No. 2050-0050 in any correspondence.

OMB Control No.: 3060-0105.

Title: Licensee Qualification Report for Multipoint Distribution Service.

Form No.: FCC Form 430.

Type of Review: Revision of a currently approved collection.

Respondents: Businesses or other for-profit, not-for-profit institutions.

Number of Respondents: 1,500.

Estimated Time Per Response: 2 hours.

Frequency of Response: On occasion and annual reporting requirement.

Total Annual Burden: 3,000 hours.

Total Annual Cost: N/A.

Needs and Uses: FCC Form 430 is filed by new applicants or annually by licensees if substantial changes occur in the organizational structure to provide information concerning corporate structure, alien ownership, and character of applicant or licensee. Applicants soliciting authority for assignment or transfer of control also file FCC Form 430. The form has been revised to remove all other services from the form except for services authorized under Part 21.

The information will be used by the Commission to determine whether the applicant is legally qualified to become or remain a licensee, as required by the Communications Act. Without such information the Commission would not be able to fulfill its responsibility under the Communications Act to make a finding as to the legal qualifications of an applicant or licensee.

OMB Control No.: 3060-0914.

Title: Petition, Pursuant to Section 7 of the Act, for a Waiver of the Airborne Cellular Rule, or, in the Alternative, for a Declaratory Ruling.

Form No.: None.

Type of Review: Extension.

Respondents: Business or other for-profit; Federal Government; State, Local or Tribal Government.

Number of Respondents: 30.

Estimated Time Per Response: 8 hours.

Frequency of Response: On occasion.

Total Annual Burden: 240 hours.

Total Annual Cost: 0.

Needs and Uses: The Commission resets a waiver of section 22.925 of the Commission's rules in order to permit AirCell and a number of cellular licensees who, jointly entered into resale agreements with AirCell, to furnish system capacity for the provision of cellular service on a secondary, conditional basis to airborne terminal units using AirCell-developed technology for a period of two years. The waiver allows airborne use of cellular telephones.

OMB Approval Number: 3060-0021.

Title: Civil Air Patrol Radio Station License.

Form No.: FCC 480.

Type of Review: Extension of a currently approved collection.

Respondents: Non-profit institutions.

Number of Respondents: 12.

Estimated Time Per Response: 5 minutes.

Total Annual Burden: 1 hour.

Total Costs to Respondents: 0.

Needs and Uses: FCC Rules require that applicants file the FCC Form 480 to apply for a new, renewed, or modified Civil Air Patrol Radio Station License. This form is required by the Communications Act of 1934, as amended; International Treaties and FCC Rules 47 CFR Parts 1.922, 87.21 and 87.31.

The data will be used by Commission personnel to evaluate the application to issue licenses, to provide information for enforcement and rulemaking proceedings and to maintain a current inventory of licensees.

This is a summary of a Public Notice released September 25, 2000. The complete text of the public notice, including the attachments, is available for inspection and copying during normal business hours in the FCC Reference Center (Room CY-A257), 445 12th Street, SW., Washington, DC. It may also be purchased from the Commission's copy contractor, International Transcription Services, Inc. (ITS, Inc.) 1231 20th Street, NW., Washington, DC 20036, (202) 857-3800. It is also available on the Commission's web site at http://www.fcc.gov .

List of Attachments available at the FCC:

1. On September 21, 2000, the Federal Communications Commission completed the auction of 104 licenses in the 700 MHz Guard Bands (“Auction No. 33”), raising (in net high bids) a total of $519,892,575.00 for the U.S. Treasury. Nine winning bidders won a total of 96 licenses in this auction.

2. The Commission's rules require that within ten business days after the release of the Public Notice, in this case 6:00 p.m. ET on October 10, 2000, winning bidders in Auction No. 33 must have on deposit with Mellon Bank in Pittsburgh, Pennsylvania, enough funds to cover all required: (i) down payments on winning bids, and (ii) payments for withdrawn bids, if applicable. If a winning bidder's upfront payment is not sufficient to meet both of these requirements, the winning bidder must deposit additional funds. See 47 CFR 1.2107(b), 1.2104(g).

3. The amount now due from each winning bidder, if any, is set out in the last column of Attachment B of the Public Notice. Note that a payment and FCC Form 159 are necessary only if a winning bidder's upfront payment does not cover the required total of down payments and withdrawn bid payments (as reflected in Attachment B) of the Public Notice. Each winning bidder's down payment must be a total of twenty (20) percent of its net winning bid(s) plus any withdrawal payments.

4. After the termination of the licensing pleading cycle ( see 47 CFR 1.2108), the Commission will issue a public notice announcing that it is prepared to grant the licenses. Within ten business days after the date of that public notice, winning bidders will be required to make full payment of the balance of their winning bids. See 47 CFR 1.2109 and 1.2107(b). Licenses will be granted only after the full and timely payment of winning bids and any applicable late fees, in accordance with § 1.2109(a). See 47 CFR 1.2109(a).

5. All payments must be in U.S. dollars and made in the form of a wire transfer. No personal checks, credit card payments, or other forms of payment will be accepted. All payments must be accompanied by a completed FCC Remittance Advice Form (FCC Form 159). If applicable, a partially completed copy of the FCC Form 159 will be sent along with the Public Notice to facilitate submission of the correct down payment. Questions regarding FCC Form 159 should be addressed to Tim Dates or Gail Glasser at 202-418-1995. Please note, however, that winning bidders are ultimately responsible for insuring the verification and submission of the correct down payment from their bank to Mellon bank.

6. Wire transfer payments must be received by Mellon Bank by 6 p.m. ET, on October 10, 2000. Winning bidders should coordinate with their bankers ahead of time regarding their wire transfers, and allow sufficient time for the wire transfer to be initiated and completed prior to the deadline. To submit funds by wire transfer, winning bidders will need the following information:

ABA Routing Number: 043000261.

Receiving Bank: Mellon Pittsburgh.

BNF: 911-6106.

OBI Field: (Skip one space between each information item) “AUCTIONPAY”.

Taxpayer Identification No. (same as FCC Form 159, Block 25).

Payment Type Code (enter “A33D”).

FCC Code 1 (same as FCC Form 159, Block 23A: “33”).

Payor Name (same as FCC Form 159, Block 2).

Lockbox No.: 358850.

7. Proper completion of the FCC Form 159 is critical to ensuring correct credit of bidder deposits. Winning bidders must use the same Taxpayer Identification Number used on their FCC Form 175. Questions concerning the calculation and submission of down payments should be directed to Gail Glasser at 202-418-1995.

8. The Commission imposes payments on bidders that withdraw high bids during the course of an auction, default on payments due after an auction closes, or those that are disqualified. See 47 CFR 1.2104(g), 1.2109.

9. Bid Withdrawal Payments. A bidder (Bidder X) that withdraws a high bid during the course of an auction is subject to a bid withdrawal payment equal to the difference between the amount withdrawn and the amount of the subsequent winning bid. If a high bid is withdrawn on a license that remains unsold at the close of the auction, Bidder X will be required to make an interim payment equal to three (3) percent of the net amount of the withdrawn bid. This payment amount is deducted from any upfront payments or down payments that Bidder X has deposited with the Commission. If, in a subsequent auction, that license receives a valid bid in an amount equal to or greater than the withdrawn bid amount, then no final bid withdrawal payment will be assessed, and Bidder X may request a refund of the interim three (3) percent payment. If, in a subsequent auction, the winning bid amount for that license is less than Bidder X's withdrawn bid amount, then Bidder X will be required to make a final bid withdrawal payment equal to either the difference between Bidder X's net withdrawn bid and the subsequent net winning bid, or the difference between Bidder X's gross withdrawn bid and the subsequent gross winning bid, whichever is less. The three (3) percent interim payment will be applied toward the withdrawal payment.

Attachment C of the Public Notice identifies bidders that owe withdrawal payments to the Commission as a result of bid withdrawals made in Auction No. 33.

10. Bid Default/Disqualification Payments. If a high bidder defaults or is disqualified after the close of the auction, the defaulting bidder will be subject to the same bid withdrawal payment obligations as described above, plus an additional payment equal to three (3) percent of the subsequent winning bid or three (3) percent of the defaulted bid, whichever is less. Where a bidding credit applies to the winning bid in either the original or the subsequent auction, the calculation of the three percent payment is based on the smaller of the two gross bids or smaller of the two net bids, whichever basis (gross or net) was used to figure the first component. Thus, if the difference between the gross bids is less than the difference between the net bids, the 3 percent payment will be computed on the lower of the gross bids. If the difference between the net bids is less than or equal to the difference between the gross bids, the 3 percent payment will be computed on the lower of the net bids. However, if the differences between both the gross bids and the net bids are less than or equal to zero, the three percent payment will be computed on the lower of the net bids.

11. If a winning bidder fails to remit the required down payment within ten (10) business days after the Commission has released the Public Notice , in this case by October 10, 2000, the bidder will be deemed to have defaulted, its application will be dismissed, and it will be liable for a default payment as described above. In such event, the Commission, at its discretion, may either auction the spectrum to existing or new applicants, or offer it to the other highest bidders (in descending order) at their final bids. See 47 CFR 1.2109(b).

12. If a winning bidder fails to pay the balance of its winning bids in a lump sum by the applicable deadline as specified by the Commission, it will be allowed to make payment within ten (10) business days after the payment deadline provided that it also pays a late fee equal to five (5) percent of the amount due. When a winning bidder fails to pay the balance of its winning bid plus late fee by the late payment deadline, it is considered to be in default on its license(s) and subject to the applicable default payments. Licenses will be awarded upon the full and timely payment of winning bids and any applicable late fees. See 47 CFR 1.2109(a). A winning bidder that is found unqualified to be a licensee, fails to remit the balance of its winning bid in a timely manner, or defaults or is disqualified for any reason after having made the required down payment, will be deemed to have defaulted and will be liable for the payment set forth in § 1.2104(g)(2). In such event, the Commission may either auction the spectrum to existing or new applicants or offer it to the other highest bidders (in descending order) at their final bids. See 47 CFR 1.2109(c).

13. Finally, bidders that are found to have violated the antitrust laws or the Commission's rules in connection with their participation in the competitive bidding process may be subject, in addition to any other applicable sanctions, to forfeiture of their upfront payment, down payment, or full bid amount, and may be prohibited from participating in future auctions. See 47 CFR 1.2109(d).

14. Upfront monies on deposit that are in excess of the required down payment, withdrawal and/or default payment amounts will be refunded to the payer of record promptly upon receipt of the necessary wire transfer instructions. Winning bidders must fax the necessary wire transfer instructions to Gail Glasser at 202-418-2843. Any questions concerning refunds should be referred to Gail Glasser or Tim Dates at 202-418-1995.

15. Non-winning bidders must fax the necessary wire transfer instructions to Gail Glasser or Tim Dates at 202-418-2843. Any questions concerning refunds for non-winning bidders should be referred to Gail Glasser or Tim Dates at 202-418-1995.

16. By 6 p.m. ET on October 10, 2000, winning bidders must submit a completed long-form license application(s) covering each license for which they were the winning high bidder. Attachment D of the Public Notice sets out instructions for completing the FCC Form 601. Applications must be filed electronically. Detailed instructions for filing the Form 601 electronically are set out in Attachment E of the Public Notice. Failure to timely file FCC Form 601 will result in default. Late-filed applications will not be accepted without a showing of good cause.

17. Pursuant to § 1.919 of the Commission's rules, an applicant for a license in an auctionable service must have on file with the Commission a current FCC Form 602 regarding ownership information of the applicant. See 47 CFR 1.919. Therefore, unless the applicant already has a current FCC Form 602 on file with the Commission, the applicant must submit one at the time the FCC Form 601 is filed. Any late-filed FCC Form 602 must contain a request for waiver of the filing requirement in 47 CFR 1.919.

18. FCC Form 602 must be filed manually (not electronically), and may be obtained from the Internet at http://www.fcc.gov/formpage.html or by calling the FCC's Form Distribution Center at 1-800-418-FORM (3676). For more detailed information on FCC Form 602, see “Wireless Telecommunications Bureau Answers Frequently Asked Questions Concerning Reporting of Ownership Information on FCC Form 602,” Public Notice , DA 99-1001 (14 FCC Rcd. 8261) 1999.

Applicants that do not have a current FCC Form 602 on file should send the form to: Federal Communications Commission, 1270 Fairfield Road, Gettysburg, PA 17325-7245.

19. Filing FCC Form 602 is a separate requirement from, and in addition to, the ownership reporting requirements associated with filing FCC Form 601, Exhibit A, as set forth in Attachment D of the Public Notice. However, to avoid duplication, applicants may provide certain information required in Exhibit A by attaching a copy of their FCC Form 602 (in Adobe PDF Format) to their FCC Form 601 submission. Applicants are reminded, however, that an original FCC Form 602 still must be filed manually in Gettysburg, PA. For further information, see Instructions in Attachment D of the Public Notice.

20. Applicants may submit one FCC Form 601 Main Form, Schedule B, and Form 602 for multiple licenses if all filing information (name and address information, all ownership and eligibility attachments, and waiver requests) associated with the application is identical. Licensing information such as market designator, channel block, and/or market name may be different ( i.e. WXMEA001A and WXMEA001B- Boston, MA; WXMEA022A—Knoxville, TN).

21. Filers whose name and address, ownership, eligibility, and waiver requests are identical for some licenses but different for other licenses must submit a separate Form 601 and 602 for those licenses for which filing information is unique. The streamlined filing procedure described in paragraph 20 may only be used for licenses that have identical filing information.

22. Applicants are no longer required to maintain accuracy and completeness of information furnished on their FCC Form 175 and exhibits. After the auction closes, applicants are required to make all changes in the ULS system (Forms 601/602).

23. Pursuant to 47 CFR 1.2108(b) and the Balanced Budget Act of 1997, Public Law 105-33, 111 Stat. 251 (1997), interested parties will have ten (10) days to file petitions to deny after the Commission releases a public notice announcing the FCC Forms 601 and 602 are acceptable for filing. An applicant may file an opposition to any petition to deny within five (5) days after the time for filing petitions to deny has expired. See 47 CFR1.2108(c). The petitioner may file a reply to such opposition within five (5) days after the time for filing oppositions has expired. See 47 CFR 1.2108(c). If the Commission determines that an applicant is qualified and there is no substantial and material issue of fact concerning that determination, the Commission will issue a public notice announcing that it is prepared to grant the application conditioned upon the full and timely payment of the remaining balance of the applicant's winning bid. Once the Commission has received full payment of the applicant's winning bid, it will issue a public notice announcing grant of the license (or licenses) to the applicant.

24. Applicants should be aware that the Policy Division of the Wireless Telecommunications Bureau has issued two Errata. The first Errata, inter alia, makes conforming amendments to § 27.308 of the Commission's Rules, concerning technical content of applications. The second Errata, inter alia, makes conforming amendments to § 27.6 of the Commission's Rules, referencing the definitional criterion for the Gulf of Mexico EA.

25. To ensure the competitiveness of the auction process, the Commission's rules prohibit applicants for the same geographic license area from communicating with each other during the auction about bids, bidding strategies, or settlements. As explained more fully in the Auction No. 33 Procedures Public Notice, 65 FR 21182 (April 20, 2000), this prohibition began with the filing of short-form applications and ends on the down payment due date. The prohibition ends on the down payment due date whether or not a high bidder must supplement its upfront payment to cover its down payment. Applicants certified their compliance with § 1.2105(c) when their FCC Form 175 short-form applications were signed.

26. The following is a list of important numbers relating to Auction No. 33:

News Media: Meribeth McCarrick at 202-418-0654.

Technical Support Hotline: Technical Support Personnel at 202-414-1250 (V) or 202-414-1255 (text telephone (TTY)).

Office of the Managing Director Auctions Accounting Group (Payment, FCC Form 159 and refund questions) Gail Glasser or Tim Dates at 202-418-1995.

Wireless Telecommunications Bureau, Commercial Wireless Division (FCC Form 601 and 602 questions) JoAnn Epps at 202-418-1342, Gary Oshinsky at 202-418-7167 or Erin McGrath at 202-418-2042.

Wireless Telecommunications Bureau, Auctions and Industry Analysis Division Auctions (Auction-related questions) Lisa Stover, Project Manager at 717-338-2888, or Howard Davenport, Attorney, at 202-418-0660.

The Public Notice was released on September 28, 2000. The document is available, in entirety, for inspection and copying during normal business hours in the FCC Reference Center (Room CY-A-257), 445 12th Street, SW, Washington, DC 20554. It may also be purchased from the Commission's copy contractor, International Transcription Services, Inc. (ITS, Inc.) 1231 20th Street, NW, Washington, DC 20036, (202) 857-3800. For background information, a copy of the R&O in ET Docket No. 99-255 can be found on the Commission's web page. The Commission's website is http://www.fcc.gov/Bureaus/Wireless/Orders/2000/fcc00076.pdf.

The Commission adopted a Report and Order (R&O) establishing a new WMTS. The WMTS is intended to enhance the ability of health care providers to offer high quality and cost-effective care to patients with acute and chronic health care needs. While WMTS equipment will be licensed by rule, the Commission concluded that it was necessary to designate a frequency coordinator(s) to maintain a database of all WMTS equipment identified by location, operating frequency, emission type and output power. The Commission believed that the database will provide a record of the frequencies used by each facility or device to assist parties in selecting frequencies to avoid interference. The Commission envisioned that the database would be used by users eligible for the WMTS and manufacturers to plan for specific frequency use within a geographic area.

1. WMTS Frequency Coordinator Duties and Responsibilities. The designated WMTS frequency coordinator(s) must be familiar with the medical telemetry user community, and must make its services available to all parties on a first-come, first-served and non-discriminatory basis. The WMTS frequency coordinator(s) must be willing to serve a five-year term, which could be renewed by the Commission. The WMTS frequency coordinator(s) will be permitted to set the fee structure associated with such frequency coordination as necessary to recoup costs. Pursuant to § 95.1113 of the Commission's Rules, a WMTS frequency coordinator will be required to: (i) Review and process coordination requests submitted by authorized health care providers as required in 47 CFR 95.1111; (ii) maintain a database of WMTS use; (iii) notify users of potential conflicts; and (iv) coordinate WMTS operation with radio astronomy observatories and Federal Government radar systems as specified in 47 CFR 95.1119 and 95.1121.

2. Each request for designation as a WMTS frequency coordinator must be signed and indicate the name and telephone number of a contact person familiar with the request. Each request must include:

(i) a description of the entity requesting to be a WMTS frequency coordinator and its qualifications;

(ii) how it will prevent any conflicts of interest;

(iii) its proposed fee structure;

(iv) length of time before applicant will be able to begin its duties as a WMTS frequency coordinator;

(v) a statement that the applicant will be able and willing to work with other WMTS frequency coordinators should WTB decide to designate more than one frequency coordinator, and

(vi) the geographic area(s) for which the applicant is willing to coordinate.

3. WTB will base its decision on the information provided. Preference will be given to applicants who can provide nationwide coordination. Once a decision has been made, the name(s) and address(es) of the designated WMTS coordinator(s) will be announced by Public Notice.

4. Requests for designation as a WMTS frequency coordinator must reference this Public Notice, including the DA number, and be filed with the Office of the Secretary, Federal Communications Commission, 445 12th Street, SW., TW-A325, Washington DC 20554. A copy of each filing should be sent to International Transcription Service, Inc. at 1231 20th Street, NW., Washington, DC 20036, and Jeffrey Tobias, Federal Communications Commission, Wireless Telecommunications Bureau, Public Safety and Private Wireless Division, Policy and Rules Branch, 445 12th Street, SW., 2-C828, Washington, DC 20554.

Released: October 3, 2000.

The North American Numbering Council (NANC) has scheduled a meeting to be held Tuesday, October 17, 2000, from 8:30 a.m. until 5 p.m., and on Wednesday, October 18, from 8:30 a.m., until 12 noon. The meeting will be held at the Federal Communications Commission, Portals II, 445 12th Street, SW, Room TW-C305, Washington, DC. This meeting is open to members of the general public. The FCC will attempt to accommodate as many participants as possible. The public may submit written statements to the NANC, which must be received two business days before the meeting. In addition, oral statements at the meeting by parties or entities not represented on the NANC will be permitted to the extent time permits. Such statements will be limited to five minutes in length by any one party or entity, and requests to make an oral statement must be received two business days before the meeting. Requests to make an oral statement or provide written comments to the NANC should be sent to Cheryl Callahan or Aaron Goldberger at the address under FOR FURTHER INFORMATION CONTACT, stated above.

1. Approval of June 20-21 and July 18-19, 2000, meeting minutes.

2. North American Numbering Plan Administration (NANPA) Report. Presentation of Enterprise Services and associated prices. Discussion of September 27 notice regarding INC issue 220.

3. North American Numbering Plan Administration (NANPA) Oversight Working Group Report. Status of NANPA technical requirements document.

4. Report of Numbering Resource Optimization (NRO). Status of NRUF Requirements Document and ITN Recommendations.

5. JFAX presentation on UMS Issues.

6. Industry Numbering Committee Report. Status of UNP.

7. Report of Toll Free Access Codes IMG.

8. Local Number Portability Administration (LNPA) Working Group Report. Wireless Number Portability Subcommittee report, Third Wireline Wireless Integration Report, and Review of Report on LNP & Pooling.

9. Report of Cost Recovery Working Group.

10. Report from NBANC.

11. Ad Hoc Voluntary UNP Study Group Report. Presentation of Business Rule Model.

12. Steering Group Meeting. Update Table of NANC Projects.

13. Steering Group Report.

14. Reseller CIC IMG Status Report.

15. NANC Discussion Group on Charging for Telephone Numbers.

16. UMS IMG Report.

17. Oversight of LLCs NPAC.

18. Public participation (5 minutes each, if any).

19. Other Business.

20. Action Items.

On May 11, 2000, the Federal Trade Commission published a Federal Register Notice announcing a public forum in the fall of 2000 to discuss warranty protection for software and other computer information products and services that are marketed to consumers, and soliciting academic papers and written comment relating to those issues. The Commission has not set October 26 and 27, 2000, as the dates for the forum. The forum will be held at the offices of the Federal Trade Commission, 600 Pennsylvania Avenue, NW., Washington, DC 20580, from 8:30 a.m. to 5:30 p.m. on October 26 and from 9:00 a.m. to 5:30 p.m. on October 27, 2000. The forum is open to the public, and there is no formal registration process for those wishing to attend. Seating is limited, but overflow rooms will be available.

Pursuant to Section 6(f) of the Federal Trade Commission Act, 38 Stat. 721, 15 U.S.C. 46, and Section 2.34 of the Commission's Rules of Practice (16 CFR 2.34), notice is hereby given that the above-captioned consent agreement containing a consent order to cease and desists, having been filed with and accepted subject to final approval, by the Commission, has been placed on the public record for a period of thirty (30) days. The following Analysis to Aid Public Comment describes the terms of the consent agreement, and the allegations in the complaint. An electronic copy of the full text of the consent agreement package can be obtained from the FTC Home page (for September 29, 2000), on the World Wide Web, at “http://www.ftc.gov/os/2000/09/index.htm.” A paper copy can be obtained from the FTC Public Reference Room, Room H-130, 600 Pennsylvania Avenue, NW., Washington, DC 20580, either in person or by calling (202) 326-3627.

Public comment is invited. Comments should be directed to: FTC/Office of the Secretary, Room 159, 600 Pennsylvania Avenue, NW., Washington, DC 20580. Two paper copies of each comment should be filed, and should be accompanied, if possible, by a 3 1/2 inch diskette containing an electronic copy of the comment. Such comments or views will be considered by the Commission and will be available for inspection and copying at its principal office in accordance with Section 4.9(b)(6)(ii) of the Commission's Rules of Practice (16 CFR 4.9(b)(6)(ii)).

The Federal Trade Commission (“Commission”) has accepted for public comment an Agreement Containing Consent Order with Agrium, Inc. (“Agrium”) and Union Oil Company of California and Unocal Corp. (“Unocal”). The purpose of the agreement is to remedy the anticompetitive effects of Agrium's proposed acquisition of Unocal's nitrogen fertilizer business. The proposed order would require that Agrium divest assets that are integral to the sale of nitrogen fertilizers in the Northwest (Washington, Oregon, and Idaho).

Nitrogen fertilizers are used by farmers around the world to improve crop yields by supplying the nitrogen essential to plant growth. Agrium, with production facilities in Texas and near its headquarters in Alberta, Canada, is one of the world's largest producers of nitrogen fertilizers. In 1998, Agrium's wholesale sales of nitrogen fertilizers were $501 million. Unocal produces and sells nitrogen fertilizers through its subsidiaries Alaska Nitrogen Products LLC and Prodica LLC, which have production and distribution facilities in Alaska, Washington, Oregon and California. Unocal's 1998 wholesale sales of nitrogen fertilizers were approximately $377 million.

Agrium and Unocal are the leading sellers of anhydrous ammonia, urea, and UAN 32% solution, which are the most popular nitrogen fertilizers in the Northwest. Substitution among these fertilizers, and between them and other nitrogen fertilizers, is limited because of agricultural considerations (they differ in their suitability for particular crops, soils, weather conditions, etc.) and commercial factors ( e.g., each of these fertilizers requires different storage and application equipment). In the manufacture of an important resin, there is no substitute for urea.

The complaint alleges that Agrium's proposed acquisition of Unocal, if consummated, may substantially lessen competition in violation of Section 7 of the Clayton Act, as amended, 15 U.S.C. 18, and Section 5 of the Federal Trade Commission Act, as amended, 15 U.S.C. 45. The complaint identifies three relevant lines of commerce (product markets) in which to analyze the effects of this acquisition: urea, ammonia, and UAN 32%. The Relevant Section of the country (geographic market) alleged in the complaint is the Northwest, which consists of the states of Washington, Oregon, and Idaho. In urea, Agrium's acquisition of Unocal would result in an increase in the Herfindahl-Hirschman Index (commonly referred to as “HHI”) from 2200 to over 4800; in ammonia, the HHI rises from 1922 to over 4200; and in UAN 32% it rises from 1560 to over 3800. By eliminating competition between Agrium and Unocal, who are the top two suppliers of each of these products in the Northwest, the acquisition would enable Agrium to unilaterally increase the prices of ammonia, urea, and UAN 32% in that geographic market.

It is unlikely that the competition eliminated by the proposed acquisition would be replaced by new entry into the Northwest. The construction of a new nitrogen fertilizer plant to supply the Northwest appears to be uneconomic. One recent attempt at building a plant in the region was abandoned four years after it was first announced. Design, site selection, permitting and construction of a new plant to supply the Northwest would require considerably more than two years. Producers with plants in the Northwest cannot expand output because these plants are operating at capacity. Importers of offshore fertilizers are unlikely to ship significantly more to the Northwest because the transfer and storage terminals they need are either unavailable or more expensive to use than Unocal's Rivergate terminal. Midwest producers face obstacles to increasing shipments to the Northwest, including high transportation costs, commitments to local customers, the attractiveness of netbacks closer to their plants, and differences in seasonal demand that often make California a better market for their product.

The proposed consent order would require that Agrium divest Unocal's deepwater terminal at Rivergate, part of its upriver terminal at Hedges (containing urea storage and land for expansion and road access), and leases on three UAN terminals (including one with deepwater access) to J.R. Simplot Company. The order would also require Agrium to provide Simplot with a long-term lease on the ammonia storage at Hedges and perpetual access to the Hedges dock, roadway, rail spur and weight scales.

The Commission is preliminarily satisfied that Simplot is well qualified to reproduce Unocal's competitive role in the Northwest. Simplot is a $2.8 billion agribusiness that, among other things, produces, wholesales and retails nitrogen and other fertilizers around North America. It operates a large nitrogen fertilizer production facility in Manitoba, numerous phosphate plants, and a chain of retail outlets. In the Northwest, Simplot is a substantial source of phosphate fertilizers, but its wholesaling of nitrogen fertilizers is very limited. The proposed divestiture would enable Simplot to become a major wholesaler of nitrogen fertilizers in the Northwest.

The proposed order requires that respondents divest the specified assets to Simplot, in accordance with the agreement between Agrium and Simplot, immediately after Agrium acquires Unocal. If, at the time the Commission decides to make the proposed consent order final, the Commission notifies the respondents that Simplot is not an acceptable acquirer, or that the agreement with Simplot is not an acceptable manner of divestiture, the respondents must immediately rescind the transaction and divest those assets to an acceptable acquirer, and in an acceptable manner, within four months of the date the proposed consent order becomes final.

For a period of ten (10) years from the date the proposed order becomes final, respondents are required to provide written notice to the Commission prior to acquiring any interest in (1) any asset to be divested or (2) any terminal with deepwater access used in the transfer and storage of UAN 32 in the Northwest. These appear to be the only assets in the Northwest whose acquisition might substantially affect competition in the sale of the relevant products but not trigger a reporting obligation under the Hart-Scott-Rodino Act. Respondents are required to provide to the Commission a report of compliance with the proposed order within thirty (30) days of the date the order becomes final every sixty (60) days thereafter until respondents have complied with the divestiture obligations. Respondents are also required to provide annual reports during the term of the order. For Agrium the term of the order would be ten years; for Unocal it would be until the assets to be divested are transferred to Agrium.

The Agreement Containing Consent Order has been placed on the public record for thirty (30) days for receipt of comments by interested persons. Comments received during this period will become part of the public record. After thirty (30) days, the Commission will again review the proposed order and the comments received and will decide whether it should withdraw from the order or make it final. By accepting the proposed order subject to final approval, the Commission anticipates that the competitive problems alleged in the complaint will be resolved. The purpose of this analysis is to invite public comment on the proposed order, including the specified divestitures, to aid the Commission in its determination of whether it should make the order final. This analysis is not intended to constitute an official interpretation of the proposed order, nor is it intended to modify the terms of the order in any way.

Pursuant to Section 6(f) of the Federal Trade Commission Act, 38 Stat. 721, 15 U.S.C. 46, and § 2.34 of the Commission's Rules of Practice (16 CFR 2.34), notice is hereby given that the above-captioned consent agreement containing a consent order to cease and desist, having been filed with and accepted, subject to final approval, by the Commission, has been placed on the public record for a period of thirty (30) days. The following Analysis to Aid Public Comment describes the terms of the consent agreement, and the allegations in the complaint. An electronic copy of the full text of the consent agreement package can be obtained from the FTC Home Page (for September 20, 2000), on the World Wide Web, at “http://www.ftc.gov/os/2000/09/index.htm.” A paper copy can be obtained from the FTC Public Reference Room, Room H-130, 600 Pennsylvania Avenue, NW., Washington, DC 20580, either in person or by calling (202) 326-3627.

Public comment is invited. Comments should be directed to: FTC/Office of the Secretary, Room 159, 600 Pennsylvania Avenue, NW., Washington, DC 20580. Two paper copies of each comment should be filed, and should be accompanied, if possible, by a 3 1/2 inch diskette containing an electronic copy of the comment. Such comments or views will be considered by the Commission and will be available for inspection and copying at its principal office in accordance with § 4.9(b)(6)(ii) of the Commission's Rules of Practice (16 CFR 4.9(b)(6)(ii))

The Federal Trade Commission has accepted, subject to final approval, an agreement with the Alaska Healthcare Network, Inc. (“AHN”) containing a proposed consent order. The agreement settles charges that AHN violated Section 5 of the Federal Trade Commission Act, 15 U.S.C. 45, by facilitating or implementing agreements among its members to fix prices and other terms of dealing with payors, and to refuse to deal with payors except on collectively-determined terms. The proposed consent order has been placed on the public record for 30 days to receive comments from interested persons. Comments received during this period will become part of the public record. After 30 days, the Commission will review the agreement and the comments received, and will decide whether it should withdraw from the agreement or make the proposed order final.

The purpose of this analysis is to facilitate public comment on the proposed order. The analysis is not intended to constitute an official interpretation of the agreement and proposed order, or to modify in any way their terms. Further, the proposed consent order has been entered into for settlement purposes only and does not constitute an admission by AHN that it violated the law or that the facts alleged in the complaint (other than jurisdictional facts) are true.

The allegations in the Commission' proposed complaint are summarized below.

Respondent AHN is a non-profit corporation composed of more than 60 percent of the physicians with active medical staff privileges at Fairbanks Memorial Hospital (the only private general acute care hospital in the Fairbanks area). AHN's members include almost half of the family and general practitioners, and from 70 to 100 percent of the internists, pediatricians, obstetrician-gynecologists, and general surgeons in full-time, year-round private practice in Fairbanks.

AHN has served as a vehicle for its physician members to negotiate collectively with health plans. When AHN was formed, a wide range of health plans, including PPOs, HMOs, and government health care purchasing cooperatives, were seeking to contract with Fairbanks physicians. AHN members authorized AHN's Executive Director to bargain on their behalf over the terms and conditions under which individual physicians would deal with third-party payors. AHN emphasized to its members that—as a result of its size and its members' agreement to allow AHN to bargain on their behalf—AHN would be able to bargain from a position of strength and thus avert the competition among physicians that might otherwise be introduced into the Fairbanks area by managed care plans.

From early 1997 through 1998, AHN negotiated price and other contract terms on behalf of its physician members with at least seven third-party payors. It used fee information collected from its member physicians to develop a fee schedule to use in contract negotiations. AHN told its members that its fee schedule represented members' usual fees, and that the fee schedule would be used to obtain a favorable level of reimbursement for area physicians. AHN's Board of Directors and Contracting Committee also adopted a model contract that required payors to use AHN's fee schedule and to delegate their credentialing, utilization review, and formulary management to AHN rather than operating their own programs.

AHN purported to operate as a “messenger model,” under which an agent conveys payors' contract offers to individual physicians, who each make an independent decision whether to accept or reject each contract. In practice, however, AHN's Executive Director and Contracting Committee bargained with payors over payment and other terms, and refused to transmit contract offers to AHN members unless the payors agreed to AHN's terms.

AHN functioned de facto as the exclusive representative of its members. Through statements in its newsletters, documents, and other media, AHN repeatedly advised members to deal with payors only through AHN in order to obtain better prices and other terms. Some payors who were seeking to enter the Fairbanks area attempted unsuccessfully to contract with individual physicians instead of dealing with AHN: physicians told the payors that AHN handled contracting for them and for other Fairbanks physicians. Payors believes that they could not go around AHN to contract individually with physicians in Fairbanks, and thus that they had no alternative but to reach agreement with AHN or give up their planned entry into Fairbanks. In several instances, payors approached individual physicians in mass mailings, requests for proposals, or phone calls, and received no responses. This was complete unprecedented and contradicted by payors' favorable responses to RFPs in other markets, including Anchorage, Alaska, and demonstrated the unwillingness of AHN and its members to deal with an entire category of payors.

AHN reached agreement with one payor—NYLCare—in 1998, and transmitted a contract to individual AHN members for their approval. AHN's Executive Director told the members that the Contracting Committee had revised the NYLCare contract proposal in a way that was responsive to the common economic interest of all AHN members. AHN engaged six other third-party payors in protracted negotiations over price and non-price terms that often extended for more than a year with no resolution. AHN demanded that the payors use AHN's fee schedule and its model contract that required payors to delegate credentialing, quality assurance, and utilization review to AHN physicians. However, AHN had not implemented any utilization review, quality assurance, or credentialing systems, and it lacked the capacity to implement some or all of those services. AHN did not refer contract offers from any of these payors to its members. As a result of AHN's conduct, a wide range of third-party payors of physician services, including PPOs, HMOs, and employer health care purchasing cooperatives, were unable to secure physician contracts and thus were unable to do business in the Fairbanks area.

AHN did not engage in any activity that might justify collective agreements on the prices its members would accept for their services. Its actions have restrained price and other competition among physicians in the Fairbanks area and thereby harmed consumers (including third-party payors, subscribers, and their employers) by increasing the prices for physician services, delaying the development of alternative health care financing and delivery systems, and limiting competition among health plans.

The proposed order is designed to prevent recurrence of the illegal concerted actions alleged in the complaint, while allowing AHN and its members to engage in legitimate joint conduct. The core prohibitions of the proposed order are contained in Paragraph II. Paragraph II.A prohibits AHN from entering into or facilitating any agreement: (1) To negotiate on behalf of any physicians with any payor or provider; (2) to deal or refuse to deal with any payor or provider; (3) regarding any term on which any physicians deal, or are willing to deal, with any payor or provider; or (4) to restrict the ability of any physician to deal with any payor or provider on an individual basis or through any other arrangement.

Paragraph II.B prohibits AHN from exchanging or facilitating the exchange of information among Fairbanks area physicians concerning: (1) Negotiation with any payor or provider regarding reimbursement terms; or (2) any physician's intentions or decisions with respect to any dealings with any payor or provider. Paragraph II.C prohibits AHN from encouraging, advising, or pressuring any person, other than the government, to engage in any action that would be prohibited if the person were subject to the order.

Paragraph II contains two provisos. The first proviso permits respondent to engage in conduct that is approved and supervised by the State of Alaska, so long as that conduct is exempt from liability under the federal antitrust laws under the state action doctrine. That doctrine protects private conduct that is both: (1) In accordance with a clearly articulated and affirmatively expressed state policy to supplant competition; and (2) actively supervised by the state itself. See, e.g., FTC v. Ticor Title Insurance Co. , 504 U.S. 621 (1992); California Retail Liquor Dealers Ass'n v. Midcal Aluminum, Inc. , 445 U.S. 97, 105 (1980).

The second proviso in Paragraph II allows AHN to engage in conduct (including collectively determining reimbursement and other terms of contracts) that is reasonably necessary to operate any “qualified risk-sharing joint arrangement” or “qualified clinically-integrated joint arrangement,” provided respondent complies with the prior notification requirements set forth in Paragraph VI of the order. The prior notification mechanism will allow the Commission to evaluate a specific proposed arrangement and assess its likely competitive impact.

As defined in the order, a “qualified risk-sharing joint arrangement” must satisfy three conditions. First, all physician participants must share substantial financial risk through the arrangement. The definition of financial risk-sharing tracks the discussion of that term contained in the 1996 FTC/DOJ Statements of Antitrust Enforcement Policy in Health Care. Second, any agreement on prices or terms of reimbursement must be reasonably necessary to obtain significant efficiencies through the joint arrangement. Third, the arrangement must be non-exclusive—that is, it must not restrict the ability, or facilitate the refusal, of participating physicians to deal with payors individually or through any other network or venture.

A “qualified clinically-integrated joint arrangement” is one in which the physicians undertake cooperative activities to achieve efficiencies in the delivery of clinical services, without necessarily sharing substantial financial risk. This definition also reflects the analysis contained in the 1996 FTC/DOJ Statements of Antitrust Enforcement Policy in Health Care. Participating physicians must establish a high degree of interdependence and cooperation through their use of programs to evaluate and modify their clinical practice patterns, in order to control costs and assure the quality of physician services provided. In addition, the arrangement must be non-exclusive, and any agreement on prices or terms of reimbursement must be reasonably necessary to obtaining significant efficiencies through the arrangement.

The proposed order also imposes a structural remedy for a period of five years. Although the Commission has not routinely imposed structural relief on physician groups in previous cases, such relief is not unprecedented. See e.g., Home Oxygen and Medical Equipment Co. , 118 F.T.C. 661 (1994) (pulmonologists prohibited for ten years from acquiring ownership interest in any entity that provides home oxygen delivery services if more than 25 percent of the pulmonologists in the area would be affiliated with the entity), and Physicians Group, Inc. , 120 F.T.C. 567 (1995) (physician organization ordered to dissolve). The Commission will continue to consider the option of structural remedies in these cases when necessary to achieve effective relief.

Paragraph III.A requires that if AHN operates a qualified risk-sharing or clinically-integrated joint arrangement, its participating physicians must constitute no more than 30 percent of Fairbanks physicians in any of the key medical specialties of family practice and general internal medicine, obstetrics and/or gynecology, pediatrics, general surgery, and orthopedic surgery. Paragraph III.B of the proposed order further requires that, when offering the services of its physicians through any other arrangement, AHN's participating physicians constitute no more than 50 percent of Fairbanks physicians in any of those specialties. Paragraph III.B permits participation by a greater percentage of physicians because it is intended to apply to arrangements in which there is no agreement among AHN participating physicians on price or other competitively significant terms, including messenger model arrangements.

Paragraph III contains two provisos. The first proviso permits AHN to include as a participating physician any single physician or any one pre-existing physician practice group, without regard to the percentage limitations. The single physician exception allows AHN to exceed the percentage limitations in instances where there may be only a few physicians in a designated medical speciality; and the one pre-existing practice group exception allows AHN to exceed the percentage limitations where the alternative would be to require an integrated practice group to downsize. The second proviso permits AHN to exceed the percentage limitations to the extent that the excess arises from certain changes in the marketplace. As a result of these provisos, once AHN is operating in conformity with percentage limitations contained in the order, it will not be required to reduce its physician membership because of (1) the addition of a physician (who was not already in practice in Fairbanks) to a member practice group, or (2) a reduction in the total number of physicians in a particular specialty (and thus in the denominator used in calculating the percentage of physicians in a specialty who can be AHN members) as a result of physician exit from the market.

The structural relief in this case is necessary to prevent continuing tacit collusion among AHN members. Fairbanks is an isolated community with a relatively small number of physicians, a high proportion of whom are AHN members. According to the allegations of the complaint, these doctors have demonstrated an unwillingness to participate in health plans independently of AHN. In these circumstances, there is a significant risk of continuing tacit collusion among AHN members that cannot adequately be addressed by an order limited to prohibiting certain specified conduct ( i.e. , AHN members might be able to coordinate their refusals to deal with payors without engaging in overt acts of collusion). Moreover, since AHN purported to operate as a messenger model, but in fact actively negotiated price and nonprice terms on behalf of its physician members, an order limited to conduct remedies would have required detailed provisions governing AHN's future operation as a messenger. The structural relief, by contrast, will permit AHN, subject to the five-year size limits, to carry on its activities as it finds most effective without detailed oversight by the Commission, so long as the core prohibitions of Paragraph II are respected.

The structural relief contained in the order responds to the particular facts of this case, and is intended to interrupt the chain of effects flowing from the conduct alleged in the complaint and to permit time for new market structures and relationships to develop among Fairbanks physicians and between the physicians and health plans. The presence of this provision in the proposed order does not suggest that other physician networks whose membership exceeds the percentage limitations are likely to have anticompetitive effects. The provision is limited to five years in order to give AHN the greatest possible freedom to respond to changing market conditions thereafter, once the effects of the challenged conduct have dissipated.

The remaining provisions of the proposed order impose obligations on AHN with respect to distributing the order and complaint to its members and other specified persons and reporting information to the Commission. The order terminates twenty years after the date it issues.

Although we have voted to accept the consent agreement in this matter because we believe the conduct remedy is justified, we also believe that one component of the relief prescribed by the proposed order—namely, the inclusion of a form of “structural” remedy to help cure the effects of respondent AHN's allegedly unlawful conduct—is inappropriate in this particular case.

If AHN elects to function as a negotiator or merely as a “messenger,” then Paragraph III of the proposed order will for five years impose, respectively, either a 30 percent or a 50 percent “cap” on the number of Fairbanks physicians in each of five “relevant physician markets” who may participate in AHN. Although we believe that limits on a physician group's “market shares” in particular specialties can be appropriate fencing-in relief for the type of conduct involved in this case, we are not persuaded that this provision will operate in a rational and predictable way in a market as small as Fairbanks. This concern is exacerbated by the first proviso to Paragraph III, which allows respondent to “grandfather” in “any one pre-existing practice group”—no matter how large—and thus to perpetuate a structure inconsistent with the goals of that paragraph.

The imposition of such structural relief in a setting like Fairbanks results in anomalies that would not arise in a larger urban area. For example, one of the five “relevant physician markets” affected by the order (pediatrics) has only seven practitioners, and five are in a grandfathered group; another “market” (ob/gyn) has only ten practitioners, six of whom are in a grandfathered group. We can certainly understand the desire to refrain from forcing the breakup of a presumably efficient practice group, but this proviso makes the percentage caps ineffective for those specialties. On the other hand, the order itself potentially inhibits the formation of similarly efficient practice groups in the specialties where the caps are effective.

Some form of structural relief might well be warranted in future cases in which the efficacy of a purely “conduct” ( i.e., “cease-and-desist”) order is in doubt. A formerly collusive group's compliance with the dictates of a conduct order (through the cessation of overtly conspiratorial behavior) does not necessarily spell the end of tacit coordination in the future. In a market with different characteristics from those involved in this case, some type of percentage cap on network membership could go a long way to bolster competition through the creation of one or more competing networks. In this market, however, we question whether the remedy makes sense.

We hope that the public comment period on this consent agreement will yield some illuminating advice from the bar, the medical community, and the public at large, both with respect to the general appropriations of structural measures in “conduct” cases and with regard to whether such measures make sense in a thinly populated market such as Fairbanks.

Pursuant to Section 6(f) of the Federal Trade Commission Act, 38 Stat. 721, 15 U.S.C. 46, and Section 2.34 of the Commission's Rules of Practice (16 CFR 2.34), notice is hereby given that the above-captioned consent agreement containing a consent order to cease and desist, having been filed with and accepted, subject to final approval, by the Commission, has been placed on the public record for a period of thirty (30) days. The following Analysis to Aid Public Comment describes the terms of the consent agreement, and the allegations in the complaint. An electronic copy of the full text of the consent agreement package can be obtained from the FTC Home Page (for September 27, 2000), on the World Wide Web, at “http://www.ftc.gov/os/2000/09/index.htm.” A paper copy can be obtained from the FTC Public Reference Room, Room H-130, 600 Pennsylvania Avenue, NW., Washington, DC 20580, either in person or by calling (202) 326-3627.

Public comment is invited. Comments should be directed to: FTC/Office of the Secretary, Room 159, 600 Pennsylvania Avenue, NW., Washington, DC 20580. Two paper copies of each comment should be filed, and should be accompanied, if possible, by a 3 1/2 inch diskette containing an electronic copy of the comment. Such comments or views will be considered by the Commission and will be available for inspection and copying at its principal office in accordance with Section 4.9(b)(6)(ii) of the Commission's Rules of Practice (16 CFR 4.9(b)(6)(ii)).

The Federal Trade Commission (“Commission”) has accepted, subject to final approval, an Agreement Containing Consent Order (“Consent Agreement”) from The Boeing Company (“Boeing”) designed to remedy the anticompetitive effects resulting from Boeing's acquisition of certain assets of General Motors Corporation. The proposed Consent Agreement prohibits Boeing from providing systems engineering and technical assistance (“SETA”) services to the United States Department of Defense (“DoD”) for a certain classified program. The proposed Consent Agreement also prohibits Boeing's launch vehicle division from gaining access to any non-public information that Boeing's satellite division receives from competing launch vehicle suppliers when those competing suppliers launch Boeing's satellites. Similarly, the proposed Consent Agreement prohibits Boeing's satellite division from gaining access to any non-public information that Boeing's launch vehicle business receives from competing satellite suppliers. In addition, the proposed Consent Agreement requires Boeing to make available all necessary satellite interface information, which is used to make a satellite compatible with a launch vehicle, to all launch vehicle suppliers.

The proposed Consent Agreement has been placed on the public record for thirty (30) days for reception of comments by interested persons. Comments received during this period will become part of the public record. After thirty (30) days, the Commission will again review the proposed Consent Agreement and any comments received, and will decide whether it should withdraw from the proposed Consent Agreement or make final the proposed Decision & Order.

Pursuant to a Stock Purchase Agreement entered into on January 13, 2000, Boeing agreed to acquire certain assets of General Motors Corporation, including Hughes Space and Communications Company, Hughes Space and Communications International, Hughes Space and Communications International Service Company, Spectrolab, Inc., Hughes Electron Dynamics, Hughes Telecommunications and Space Company's 2.69% interest in ICO Global Communications Ltd., and Hughes Telecommunications and Space Company's 2% interest in Thuraya Satellite Telecommunications Private Joint Stock Company, for approximately $3.75 billion. The Commission's Complaint alleges that the transaction, if consummated, would violate Section 7 of the Clayton Act, as amended, 15 U.S.C. 45, and Section 5 of the FTC Act, as amended, 15 U.S.C. 18, in the following markets:

(1) A certain classified program for which Boeing is providing SETA services;  1

(2) The research, development, manufacture, and sale of commercial geosynchronous earth orbit satellites;

(3) The research, development, manufacture, and sale of commercial medium earth orbit satellites;

(4) The research, development, manufacture, and sale of commercial low earth orbit satellites;

(5) The research, development, manufacture, and sale of government satellites; and

(6) The research, development, manufacture, and sale of launch vehicles.

The proposed Consent Agreement remedies the alleged violations in each market. First, Boeing is the sole supplier of SETA services to DoD for a certain classified program. Boeing provides these services to DoD under a classified contract identified for purposes of the Complaint as Contract 4208. Hughes is one of two competing contractors for the classified program for which Boeing is providing SETA services. Thus, as result of the proposed acquisition, Boeing would be both the provider of SETA services and a competing contractor for this classified program.

As a SETA contractor, Boeing must receive a great deal of competitively sensitive information, including detailed cost and bidding data, from contractors competing for the classified program. With access to such information, Boeing may be able to raise prices for the classified program by bidding less aggressively than it otherwise would. In addition, Boeing's position as SETA contractor could enable it anticompetitively to favor itself and/or disfavor its competitors in a number of ways, such as submitting unfair evaluations of its competitors' proposals.

The proposed Consent Agreement remedies the proposed acquisition's potential anticompetitive effects in this classified program by prohibiting Boeing from performing certain SETA services for this classified program in the future. To prevent the anticompetitive exchange of information, the Consent Agreement requires Boeing to: (1) Use non-public SETA services information only its capacity as provider of technical assistance to DoD, or for the provision of SETA services not prohibited by the Order; and (2) erect a “firewall” between its SETA services division and Boeing's satellite division. In addition, to assist DoD in the transition of these SETA services responsibilities to one of its own research and development centers, the Consent Agreement further requires Boeing to: (1) Provide technical assistance, at the request of DoD, for a period not to exceed one year; and (2) provide to DoD all documents relating to certain SETA services that Boeing has received in its role as SETA contractor.

Second, Hughes is a significant supplier of satellites and Boeing is a significant supplier of launch vehicles, which are used to launch satellites from the Earth's surface into space. In order for a launch vehicle to launch a satellite, launch vehicle suppliers and satellite suppliers must work closely together and share a substantial amount of proprietary and competitively sensitive information to integrate the two products. Thus, as a significant supplier of launch vehicles, Boeing/Hughes would have access to competitively sensitive information of competing satellite manufacturers which it could share with its satellite divisions. If Boeing's satellite divisions gained access to this information, Boeing would be able to determine the cost and technology involved in its competitors' satellite proposals. This could have immediate anticompetitive consequences on upcoming satellite procurements by allowing Boeing to bid less aggressively than it otherwise would. In addition, the incentives of other satellite suppliers to invest in future technological advancements could be reduced due to concerns that Boeing would be able to “free-ride” off its competitors' technological innovations. As a significant supplier of satellites, Boeing/Hughes likewise would have access to sensitive information of competing launch vehicle providers. If Boeing's launch vehicle division were to gain access to this information, it could allow Boeing to bid less aggressively in upcoming launch vehicle procurements and reduce incentives of competitors to invest in technological innovation.

The proposed Consent Agreement is designed to protect the proprietary and competitively sensitive information of launch vehicle and satellite suppliers. Specifically, the Consent Agreement prohibits Boeing's satellite business from making any non-public launch vehicle information obtained from any launch vehicle provider available to Boeing's launch vehicle business. Under the proposed Consent Agreement, Boeing may only use such information as a provider of satellites. Similarly, the proposed Consent Agreement prohibits Boeing's launch vehicle business from making any non-public satellite information obtained from any satellite supplier available to Boeing's satellite business. Under the terms of the Consent Agreement, Boeing may only use such information in its capacity as a launch vehicle provider. The Commission has issued similar orders limiting potentially anticompetitive information transfers following mergers or acquisitions, including: Lockheed Martin , (C-3685) (September 20, 1996); Raytheon Company , (C-3681) (September 10, 1996); Lockheed Corporation/Martin Marietta Corporation , (C-3576) (May 9, 1995); Alliant Techsystems Inc. , (C-3567) (April 7, 1995); Martin Marietta , (C-3500) (June 28, 1994).

Third, the proposed acquisition raises concern that Boeing could withhold satellite interface information, which is necessary to integrate a satellite with a launch vehicle, from its launch vehicle competitors. If Boeing were to withhold such satellite interface information, it could potentially disadvantage or raise the costs of other launch vehicle suppliers that are competing to launch Boeing's satellites, and ultimately to customers. The proposed Consent Agreement remedies this concern by requiring that for any satellite manufactured by Boeing/Hughes prior to the date the Consent Agreement becomes final, Boeing must provide satellite interface information, as that term is defined in the Consent Agreement, to any launch vehicle supplier within thirty (30) days from the date Boeing receives a request for such information. The Order also requires Boeing to notify all launch vehicle suppliers, in writing, that satellite interface information relating to any Boeing/Hughes satellite bus, model, or product line is available upon request. Boeing/Hughes is also required to provide each launch vehicle supplier with instructions on how to request such information. The Consent Agreement further requires Boeing to provide satellite interface information relating to any of its satellite buses, models, or product lines manufactured after the date this Consent Agreement becomes final, to any launch vehicle supplier that requests such information or to whom Boeing previously supplied satellite interface information. However, for each satellite manufactured for the United States Government, Boeing shall only be required to provide satellite interface information to any launch vehicle supplier specified by the United States Government. In addition, the Consent Agreement requires Boeing/Hughes to provide satellite interface information to any launch vehicle supplier specified by any satellite customer no later than Boeing provides such information to its own launch vehicle businesses.

Fourth, the Commission has appointed Sheila Widnall as a monitor trustee pursuant to the proposed Consent Agreement to ensure that Boeing complies with the provisions of the Order. The monitor trustee will, among other things, assist the Commission in monitoring Boeing's compliance with the firewall requirements of the Order and Boeing's efforts to provide satellite interface information to other launch vehicle competitors. Because satellite interface information often involves technical information, the monitor trustee will aid in evaluating the contents of the satellite interface information that is to be distributed. Under the provisions of the Consent Agreement, the monitor trustee will serve for a period of ten (10) years and provide, among other things, written reports sixty (60) days after she is appointed detailing Boeing's compliance with the proposed Consent Agreement and annually thereafter for the next ten (10) on the anniversary of the date the Decision and Order becomes final.

The purpose of this analysis is to facilitate public comment on the Consent Agreement and Decision & Order, and it is not intended to constitute an official interpretation of the Consent Agreement and Decision & Order or to modify their terms in any way.

The creation of compliance program guidances is a major initiative of the OIG in its effort to engage the private health care community in preventing the submission of erroneous claims and in combating fraudulent conduct. In the past several years, the OIG has developed and issued compliance program guidances directed at a variety of segments in the health care industry. The development of these types of compliance program guidances is based on our belief that a health care provider can use internal controls to more efficiently monitor adherence to applicable statutes, regulations and program requirements.

Copies of these compliance program guidances can be found on the OIG web site at http://www.hhs.gov/oig.

On September 8, 1999, the OIG published a solicitation notice seeking information and recommendations for developing formal guidance for individual and small group physician practices (64 FR 48846). In response to that solicitation notice, the OIG received 83 comments from various outside sources. We carefully considered those comments, as well as previous OIG publications, such as other compliance program guidance and Special Fraud Alerts, in developing a guidance for individual and small group physician practices. In addition, we have consulted with the Health Care Financing Administration and the Department of Justice. In an effort to ensure that all parties had a reasonable opportunity to provide input into a final product, draft guidance for individual and small group physician practices was published in the Federal Register on June 12, 2000 (65 FR 36818) for further comments and recommendations.

This compliance program guidance for individual and small group physician practices contains seven components that provide a solid basis upon which a physician practice can create a voluntary compliance program:

• Conducting internal monitoring and auditing;

• Implementing compliance and practice standards;

• Designating a compliance officer or contact;

• Conducting appropriate training and education;

• Responding appropriately to detected offenses and developing corrective action;

• Developing open lines of communication; and

• Enforcing disciplinary standards through well-publicized guidelines.

Similar components have been contained in previous guidances issued by the OIG. However, unlike other guidances issued by OIG, this guidance for physicians does not suggest that physician practices implement all seven components of a full scale compliance program. Instead, the guidance emphasizes a step by step approach to follow in developing and implementing a voluntary compliance program. This change is in recognition of the financial and staffing resource constraints faced by physician practices. The guidance should not be viewed as mandatory or as an all-inclusive discussion of the advisable components of a compliance program. Rather, the document is intended to present guidance to assist physician practices that voluntarily choose to develop a compliance program.

This compliance program guidance is intended to assist individual and small group physician practices (“physician practices”)  1 in developing a voluntary compliance program that promotes adherence to statutes and regulations applicable to the Federal health care programs (“Federal health care program requirements”). The goal of voluntary compliance programs is to provide a tool to strengthen the efforts of health care providers to prevent and reduce improper conduct. These programs can also benefit physician practices 2 by helping to streamline business operations.

Many physicians have expressed an interest in better protecting their practices from the potential for erroneous or fraudulent conduct through the implementation of voluntary compliance programs. The Office of Inspector General (OIG) believes that the great majority of physicians are honest and share our goal of protecting the integrity of Medicare and other Federal health care programs. To that end, all health care providers have a duty to ensure that the claims submitted to Federal health care programs are true and accurate. The development of voluntary compliance programs and the active application of compliance principles in physician practices will go a long way toward achieving this goal.

Through this document, the OIG provides its views on the fundamental components of physician practice compliance programs, as well as the principles that a physician practice might consider when developing and implementing a voluntary compliance program. While this document presents basic procedural and structural guidance for designing a voluntary compliance program, it is not in and of itself a compliance program. Indeed, as recognized by the OIG and the health care industry, there is no “one size fits all” compliance program, especially for physician practices. Rather, it is a set of guidelines that physician practices can consider if they choose to develop and implement a compliance program.

As with the OIG's previous guidance,  3 these guidelines are not mandatory. Nor do they represent an all-inclusive document containing all components of a compliance program. Other OIG outreach efforts, as well as other Federal agency efforts to promote compliance, 4 can also be used in developing a compliance program. However, as explained later, if a physician practice adopts a voluntary and active compliance program, it may well lead to benefits for the physician practice.

This guidance focuses on voluntary compliance measures related to claims submitted to the Federal health care programs. Issues related to private payor claims may also be covered by a compliance plan if the physician practice so desires.

The guidance is also limited in scope by focusing on the development of voluntary compliance programs for individual and small group physician practices. The difference between a small practice and a large practice cannot be determined by stating a particular number of physicians. Instead, our intent in narrowing the guidance to the small practices subset was to provide guidance to those physician practices whose financial or staffing resources would not allow them to implement a full scale, institutionally structured compliance program as set forth in the Third Party Medical Billing Guidance or other previously released OIG guidance. A compliance program can be an important tool for physician practices of all sizes and does not have to be costly, resource-intensive or time-intensive.

The OIG acknowledges that patient care is, and should be, the first priority of a physician practice. However, a practice's focus on patient care can be enhanced by the adoption of a voluntary compliance program. For example, the increased accuracy of documentation that may result from a compliance program will actually assist in enhancing patient care. The OIG believes that physician practices can realize numerous other benefits by implementing a compliance program. A well-designed compliance program can:

• Speed and optimize proper payment of claims;

• Minimize billing mistakes;

• Reduce the chances that an audit will be conducted by HCFA or the OIG; and

• Avoid conflicts with the self-referral and anti-kickback statutes.

The incorporation of compliance measures into a physician practice should not be at the expense of patient care, but instead should augment the ability of the physician practice to provide quality patient care.

Voluntary compliance programs also provide benefits by not only helping to prevent erroneous or fraudulent claims, but also by showing that the physician practice is making additional good faith efforts to submit claims appropriately. Physicians should view compliance programs as analogous to practicing preventive medicine for their practice. Practices that embrace the active application of compliance principles in their practice culture and put efforts towards compliance on a continued basis can help to prevent problems from occurring in the future.

A compliance program also sends an important message to a physician practice's employees that while the practice recognizes that mistakes will occur, employees have an affirmative, ethical duty to come forward and report erroneous or fraudulent conduct, so that it may be corrected.

The applicability of these recommendations will depend on the circumstances and resources of the particular physician practice.

Each physician practice can undertake reasonable steps to implement compliance measures, depending on the size and resources of that practice. Physician practices can rely, at least in part, upon standard protocols and current practice procedures to develop an appropriate compliance program for that practice. In fact, many physician practices already have established the framework of a compliance program without referring to it as such.

There appear to be significant misunderstandings within the physician community regarding the critical differences between what the Government views as innocent “erroneous” claims on the one hand and “fraudulent” (intentionally or recklessly false) health care claims on the other. Some physicians feel that Federal law enforcement agencies have maligned medical professionals, in part, by a perceived focus on innocent billing errors. These physicians are under the impression that innocent billing errors can subject them to civil penalties, or even jail. These impressions are mistaken.

To address these concerns, the OIG would like to emphasize the following points. First, the OIG does not disparage physicians, other medical professionals or medical enterprises. In our view, the great majority of physicians are working ethically to render high quality medical care and to submit proper claims.

Second, under the law, physicians are not subject to criminal, civil or administrative penalties for innocent errors, or even negligence. The Government's primary enforcement tool, the civil False Claims Act, covers only offenses that are committed with actual knowledge of the falsity of the claim, reckless disregard, or deliberate ignorance of the falsity of the claim. 5 The False Claims Act does not encompass mistakes, errors, or negligence. The Civil Monetary Penalties Law, an administrative remedy, similar in scope and effect to the False Claims Act, has exactly the same standard of proof. 6 The OIG is very mindful of the difference between innocent errors (“erroneous claims”) on one hand, and reckless or intentional conduct (“fraudulent claims”) on the other. For criminal penalties, the standard is even higher—criminal intent to defraud must be proved beyond a reasonable doubt.

Third, even ethical physicians (and their staffs) make billing mistakes and errors through inadvertence or negligence. When physicians discover that their billing errors, honest mistakes, or negligence result in erroneous claims, the physician practice should return the funds erroneously claimed, but without penalties. In other words, absent a violation of a civil, criminal or administrative law, erroneous claims result only in the return of funds claimed in error.

Fourth, innocent billing errors are a significant drain on the Federal health care programs. All parties (physicians, providers, carriers, fiscal intermediaries, Government agencies, and beneficiaries) need to work cooperatively to reduce the overall error rate.

Finally, it is reasonable for physicians (and other providers) to ask: what duty do they owe the Federal health care programs? The answer is that all health care providers have a duty to reasonably ensure that the claims submitted to Medicare and other Federal health care programs are true and accurate. The OIG continues to engage the provider community in an extensive, good faith effort to work cooperatively on voluntary compliance to minimize errors and to prevent potential penalties for improper billings before they occur. We encourage all physicians and other providers to join in this effort.

The OIG believes that a basic framework for any voluntary compliance program begins with a review of the seven basic components of an effective compliance program. A review of these components provides physician practices with an overview of the scope of a fully developed and implemented compliance program. The following list of components, as set forth in previous OIG compliance program guidances, can form the basis of a voluntary compliance program for a physician practice:

• Conducting internal monitoring and auditing through the performance of periodic audits;

• Implementing compliance and practice standards through the development of written standards and procedures;

• Designating a compliance officer or contact(s) to monitor compliance efforts and enforce practice standards;

• Conducting appropriate training and education on practice standards and procedures;

• Responding appropriately to detected violations through the investigation of allegations and the disclosure of incidents to appropriate Government entities;

• Developing open lines of communication, such as (1) discussions at staff meetings regarding how to avoid erroneous or fraudulent conduct and (2) community bulletin boards, to keep practice employees updated regarding compliance activities; and

• Enforcing disciplinary standards through well-publicized guidelines.

These seven components provide a solid basis upon which a physician practice can create a compliance program. The OIG acknowledges that full implementation of all components may not be feasible for all physician practices. Some physician practices may never fully implement all of the components. However, as a first step, physician practices can begin by adopting only those components which, based on a practice's specific history with billing problems and other compliance issues, are most likely to provide an identifiable benefit.

The extent of implementation will depend on the size and resources of the practice. Smaller physician practices may incorporate each of the components in a manner that best suits the practice. By contrast, larger physician practices often have the means to incorporate the components in a more systematic manner. For example, larger physician practices can use both this guidance and the Third-Party Medical Billing Compliance Program Guidance, which provides a more detailed compliance program structure, to create a compliance program unique to the practice.

The OIG recognizes that physician practices need to find the best way to achieve compliance for their given circumstances. Specifically, the OIG encourages physician practices to participate in other provider's compliance programs, such as the compliance programs of the hospitals or other settings in which the physicians practice. Physician Practice Management companies also may serve as a source of compliance program guidance. A physician practice's participation in such compliance programs could be a way, at least partly, to augment the practice's own compliance efforts.

The opportunities for collaborative compliance efforts could include participating in training and education programs or using another entity's policies and procedures as a template from which the physician practice creates its own version. The OIG encourages this type of collaborative effort, where the content is appropriate to the setting involved (i.e., the training is relevant to physician practices as well as the sponsoring provider), because it provides a means to promote the desired objective without imposing excessive burdens on the practice or requiring physicians to undertake duplicative action. However, to prevent possible anti-kickback or self-referral issues, the OIG recommends that physicians consider limiting their participation in a sponsoring provider's compliance program to the areas of training and education or policies and procedures.

The key to avoiding possible conflicts is to ensure that the entity providing compliance services to a physician practice (its referral source) is not perceived as nor is it operating the practice compliance program at no charge. For example, if the sponsoring entity conducted claims review for the physician practice as part of a compliance program or provided compliance oversight without charging the practice fair market value for those services, the anti-kickback and Stark self-referral laws would be implicated. The payment of fair market value by referral sources for compliance services will generally address these concerns.

As previously discussed, implementing a voluntary compliance program can be a multi-tiered process. Initial development of the compliance program can be focused on practice risk areas that have been problematic for the practice such as coding and billing. Within this area, the practice should examine its claims denial history or claims that have resulted in repeated overpayments, and identify and correct the most frequent sources of those denials or overpayments. A review of claim denials will help the practice scrutinize a significant risk area and improve its cash flow by submitting correct claims that will be paid the first time they are submitted. As this example illustrates, a compliance program for a physician practice often makes sound business sense.

The following is a suggested order of the steps a practice could take to begin the development of a compliance program. The steps outlined below articulate all seven components of a compliance program and there are numerous suggestions for implementation within each component. Physician practices should keep in mind, as stated earlier, that it is up to the practice to determine the manner in which and the extent to which the practice chooses to implement these voluntary measures.

An ongoing evaluation process is important to a successful compliance program. This ongoing evaluation includes not only whether the physician practice's standards and procedures are in fact current and accurate, but also whether the compliance program is working, i.e. , whether individuals are properly carrying out their responsibilities and claims are submitted appropriately. Therefore, an audit is an excellent way for a physician practice to ascertain what, if any, problem areas exist and focus on the risk areas that are associated with those problems. There are two types of reviews that can be performed as part of this evaluation: (1) A standards and procedures review; and (2) a claims submission audit.

It is recommended that an individual(s) in the physician practice be charged with the responsibility of periodically reviewing the practice's standards and procedures to determine if they are current and complete. If the standards and procedures are found to be ineffective or outdated, they should be updated to reflect changes in Government regulations or compendiums generally relied upon by physicians and insurers ( i.e. , changes in Current Procedural Terminology (CPT) and ICD-9-CM codes).

In addition to the standards and procedures themselves, it is advisable that bills and medical records be reviewed for compliance with applicable coding, billing and documentation requirements. The individuals from the physician practice involved in these self-audits would ideally include the person in charge of billing (if the practice has such a person) and a medically trained person ( e.g. , registered nurse or preferably a physician (physicians can rotate in this position)). Each physician practice needs to decide for itself whether to review claims retrospectively or concurrently with the claims submission. In the Third-Party Medical Billing Compliance Program Guidance, the OIG recommended that a baseline, or “snapshot,” be used to enable a practice to judge over time its progress in reducing or eliminating potential areas of vulnerability. This practice, known as “benchmarking,” allows a practice to chart its compliance efforts by showing a reduction or increase in the number of claims paid and denied.

The practice's self-audits can be used to determine whether:

• Bills are accurately coded and accurately reflect the services provided (as documented in the medical records);

• Documentation is being completed correctly;

• Services or items provided are reasonable and necessary; and

• Any incentives for unnecessary services exist.

A baseline audit examines the claim development and submission process, from patient intake through claim submission and payment, and identifies elements within this process that may contribute to non-compliance or that may need to be the focus for improving execution. 7 This audit will establish a consistent methodology for selecting and examining records, and this methodology will then serve as a basis for future audits.

There are many ways to conduct a baseline audit. The OIG recommends that claims/services that were submitted and paid during the initial three months after implementation of the education and training program be examined, so as to give the physician practice a benchmark against which to measure future compliance effectiveness.

Following the baseline audit, a general recommendation is that periodic audits be conducted at least once each year to ensure that the compliance program is being followed. Optimally, a randomly selected number of medical records could be reviewed to ensure that the coding was performed accurately. Although there is no set formula to how many medical records should be reviewed, a basic guide is five or more medical records per Federal payor ( i.e. , Medicare, Medicaid), or five to ten medical records per physician. The OIG realizes that physician practices receive reimbursement from a number of different payors, and we would encourage a physician practice's auditing/monitoring process to consist of a review of claims from all Federal payors from which the practice receives reimbursement. Of course, the larger the sample size, the larger the comfort level the physician practice will have about the results. However, the OIG is aware that this may be burdensome for some physician practices, so, at a minimum, we would encourage the physician practice to conduct a review of claims that have been reimbursed by Federal health care programs.

If problems are identified, the physician practice will need to determine whether a focused review should be conducted on a more frequent basis. When audit results reveal areas needing additional information or education of employees and physicians, the physician practice will need to analyze whether these areas should be incorporated into the training and educational system.

There are many ways to identify the claims/services from which to draw the random sample of claims to be audited. One methodology is to choose a random sample of claims/services from either all of the claims/services a physician has received reimbursement for or all claims/services from a particular payor. Another method is to identify risk areas or potential billing vulnerabilities. The codes associated with these risk areas may become the universe of claims/services from which to select the sample. The OIG recommends that the physician practice evaluate claims/services selected to determine if the codes billed and reimbursed were accurately ordered, performed, and reasonable and necessary for the treatment of the patient.

One of the most important components of a successful compliance audit protocol is an appropriate response when the physician practice identifies a problem. This action should be taken as soon as possible after the date the problem is identified. The specific action a physician practice takes should depend on the circumstances of the situation. In some cases, the response can be as straight forward as generating a repayment with appropriate explanation to Medicare or the appropriate payor from which the overpayment was received. In others, the physician practice may want to consult with a coding/billing expert to determine the next best course of action. There is no boilerplate solution to how to handle problems that are identified.

It is a good business practice to create a system to address how physician practices will respond to and report potential problems. In addition, preserving information relating to identification of the problem is as important as preserving information that tracks the physician practice's reaction to, and solution for, the issue.

After the internal audit identifies the practice's risk areas, the next step is to develop a method for dealing with those risk areas through the practice's standards and procedures. Written standards and procedures are a central component of any compliance program. Those standards and procedures help to reduce the prospect of erroneous claims and fraudulent activity by identifying risk areas for the practice and establishing tighter internal controls to counter those risks, while also helping to identify any aberrant billing practices. Many physician practices already have something similar to this called “practice standards” that include practice policy statements regarding patient care, personnel matters and practice standards and procedures on complying with Federal and State law.

The OIG believes that written standards and procedures can be helpful to all physician practices, regardless of size and capability. If a lack of resources to develop such standards and procedures is genuinely an issue, the OIG recommends that a physician practice focus first on those risk areas most likely to arise in its particular practice. 8 Additionally, if the physician practice works with a physician practice management company (PPMC), independent practice association (IPA), physician-hospital organization, management services organization (MSO) or third-party billing company, the practice can incorporate the compliance standards and procedures of those entities, if appropriate, into its own standards and procedures. Many physician practices have found that the adoption of a third party's compliance standards and procedures, as appropriate, has many benefits and the result is a consistent set of standards and procedures for a community of physicians as well as having just one entity that can then monitor and refine the process as needed. This sharing of compliance responsibilities assists physician practices in rural areas that do not have the staff to perform these functions, but do belong to a group that does have the resources. Physician practices using another entity's compliance materials will need to tailor those materials to the physician practice where they will be applied.

Physician practices that do not have standards or procedures in place can develop them by: (1) Developing a written standards and procedures manual; and (2) updating clinical forms periodically to make sure they facilitate and encourage clear and complete documentation of patient care. A practice's standards could also identify the clinical protocol(s), pathway(s), and other treatment guidelines followed by the practice.

Creating a resource manual from publicly available information may be a cost-effective approach for developing additional standards and procedures. For example, the practice can develop a “binder” that contains the practice's written standards and procedures, relevant HCFA directives and carrier bulletins, and summaries of informative OIG documents ( e.g., Special Fraud Alerts, Advisory Opinions, inspection and audit reports). 9 If the practice chooses to adopt this idea, the binder should be updated as appropriate and located in a readily accessible location.

If updates to the standards and procedures are necessary, those updates should be communicated to employees to keep them informed regarding the practice's operations. New employees can be made aware of the standards and procedures when hired and can be trained on their contents as part of their orientation to the practice. The OIG recommends that the communication of updates and training of new employees occur as soon as possible after either the issuance of a new update or the hiring of a new employee.

The OIG recognizes that many physician practices may not have in place standards and procedures to prevent erroneous or fraudulent conduct in their practices. In order to develop standards and procedures, the physician practice may consider what types of fraud and abuse related topics need to be addressed based on its specific needs. One of the most important things in making that determination is a listing of risk areas where the practice may be vulnerable.

To assist physician practices in performing this initial assessment, the OIG has developed a list of four potential risk areas affecting physician practices. These risk areas include: (a) Coding and billing; (b) reasonable and necessary services; (c) documentation; and (d) improper inducements, kickbacks and self-referrals. This list of risk areas is not exhaustive, or all-encompassing. Rather, it should be viewed as a starting point for an internal review of potential vulnerabilities within the physician practice. 10 The objective of such an assessment is to ensure that key personnel in the physician practice are aware of these major risk areas and that steps are taken to minimize, to the extent possible, the types of problems identified. While there are many ways to accomplish this objective, clear written standards and procedures that are communicated to all employees are important to ensure the effectiveness of a compliance program. Specifically, the following are discussions of risk areas for physician practices:  11

a. Coding and Billing. A major part of any physician practice's compliance program is the identification of risk areas associated with coding and billing. The following risk areas associated with billing have been among the most frequent subjects of investigations and audits by the OIG:

• Billing for items or services not rendered or not provided as claimed;  12

• Submitting claims for equipment, medical supplies and services that are not reasonable and necessary;  13

• Double billing resulting in duplicate payment;  14

• Billing for non-covered services as if covered;  15

• Knowing misuse of provider identification numbers, which results in improper billing;  16

• Unbundling (billing for each component of the service instead of billing or using an all-inclusive code);  17

• Failure to properly use coding modifiers;  18

• Clustering;  19 and

• Upcoding the level of service provided. 20

The physician practice written standards and procedures concerning proper coding reflect the current reimbursement principles set forth in applicable statutes, regulations  21 and Federal, State or private payor health care program requirements and should be developed in tandem with coding and billing standards used in the physician practice. Furthermore, written standards and procedures should ensure that coding and billing are based on medical record documentation. Particular attention should be paid to issues of appropriate diagnosis codes and individual Medicare Part B claims (including documentation guidelines for evaluation and management services). 22 A physician practice can also institute a policy that the coder and/or physician review all rejected claims pertaining to diagnosis and procedure codes. This step can facilitate a reduction in similar errors.

b. Reasonable and Necessary Services. A practice's compliance program may provide guidance that claims are to be submitted only for services that the physician practice finds to be reasonable and necessary in the particular case. The OIG recognizes that physicians should be able to order any tests, including screening tests, they believe are appropriate for the treatment of their patients. However, a physician practice should be aware that Medicare will only pay for services that meet the Medicare definition of reasonable and necessary. 23

Medicare (and many insurance plans) may deny payment for a service that is not reasonable and necessary according to the Medicare reimbursement rules. Thus, when a physician provides services to a Medicare beneficiary, he or she should only bill those services that meet the Medicare standard of being reasonable and necessary for the diagnosis and treatment of a patient. A physician practice can bill in order to receive a denial for services, but only if the denial is needed for reimbursement from the secondary payor. Upon request, the physician practice should be able to provide documentation, such as a patient's medical records and physician's orders, to support the appropriateness of a service that the physician has provided.

c. Documentation. Timely, accurate and complete documentation is important to clinical patient care. This same documentation serves as a second function when a bill is submitted for payment, namely, as verification that the bill is accurate as submitted. Therefore, one of the most important physician practice compliance issues is the appropriate documentation of diagnosis and treatment. Physician documentation is necessary to determine the appropriate medical treatment for the patient and is the basis for coding and billing determinations. Thorough and accurate documentation also helps to ensure accurate recording and timely transmission of information.

i. Medical Record Documentation. In addition to facilitating high quality patient care, a properly documented medical record verifies and documents precisely what services were actually provided. The medical record may be used to validate: (a) The site of the service; (b) the appropriateness of the services provided; (c) the accuracy of the billing; and (d) the identity of the care giver (service provider). Examples of internal documentation guidelines a practice might use to ensure accurate medical record documentation include the following:  24

• The medical record is complete and legible;

• The documentation of each patient encounter includes the reason for the encounter; any relevant history; physical examination findings; prior diagnostic test results; assessment, clinical impression, or diagnosis; plan of care; and date and legible identity of the observer;

• If not documented, the rationale for ordering diagnostic and other ancillary services can be easily inferred by an independent reviewer or third party who has appropriate medical training;

• CPT and ICD-9-CM codes used for claims submission are supported by documentation and the medical record; and

• Appropriate health risk factors are identified. The patient's progress, his or her response to, and any changes in, treatment, and any revision in diagnosis is documented.

The CPT and ICD-9-CM codes reported on the health insurance claims form should be supported by documentation in the medical record and the medical chart should contain all necessary information. Additionally, HCFA and the local carriers should be able to determine the person who provided the services. These issues can be the root of investigations of inappropriate or erroneous conduct, and have been identified by HCFA and the OIG as a leading cause of improper payments.

One method for improving quality in documentation is for a physician practice to compare the practice's claim denial rate to the rates of other practices in the same specialty to the extent that the practice can obtain that information from the carrier. Physician coding and diagnosis distribution can be compared for each physician within the same specialty to identify variances.

ii. HCFA 1500 Form. Another documentation area for physician practices to monitor closely is the proper completion of the HCFA 1500 form. The following practices will help ensure that the form has been properly completed:

• Link the diagnosis code with the reason for the visit or service;

• Use modifiers appropriately;

• Provide Medicare with all information about a beneficiary's other insurance coverage under the Medicare Secondary Payor (MSP) policy, if the practice is aware of a beneficiary's additional coverage.

d. Improper Inducements, Kickbacks and Self-Referrals. A physician practice would be well advised to have standards and procedures that encourage compliance with the anti-kickback statute  25 and the physician self-referral law. 26 Remuneration for referrals is illegal because it can distort medical decision-making, cause overutilization of services or supplies, increase costs to Federal health care programs, and result in unfair competition by shutting out competitors who are unwilling to pay for referrals. Remuneration for referrals can also affect the quality of patient care by encouraging physicians to order services or supplies based on profit rather than the patients' best medical interests. 27

In particular, arrangements with hospitals, hospices, nursing facilities, home health agencies, durable medical equipment suppliers, pharmaceutical manufacturers and vendors are areas of potential concern. In general the anti-kickback statute prohibits knowingly and willfully giving or receiving anything of value to induce referrals of Federal health care program business. It is generally recommended that all business arrangements wherein physician practices refer business to, or order services or items from, an outside entity should be on a fair market value basis. 28 Whenever a physician practice intends to enter into a business arrangement that involves making referrals, the arrangement should be reviewed by legal counsel familiar with the anti-kickback statute and physician self-referral statute.

In addition to developing standards and procedures to address arrangements with other health care providers and suppliers, physician practices should also consider implementing measures to avoid offering inappropriate inducements to patients. 29 Examples of such inducements include routinely waiving coinsurance or deductible amounts without a good faith determination that the patient is in financial need or failing to make reasonable efforts to collect the cost-sharing amount. 30

Possible risk factors relating to this risk area that could be addressed in the practice's standards and procedures include:

• Financial arrangements with outside entities to whom the practice may refer Federal health care program business; 31

• Joint ventures with entities supplying goods or services to the physician practice or its patients; 32

• Consulting contracts or medical directorships;

• Office and equipment leases with entities to which the physician refers; and

• Soliciting, accepting or offering any gift or gratuity of more than nominal value to or from those who may benefit from a physician practice's referral of Federal health care program business. 33

In order to keep current with this area of the law, a physician practice may obtain copies, available on the OIG web site or in hard copy from the OIG, of all relevant OIG Special Fraud Alerts and Advisory Opinions that address the application of the anti-kickback and physician self-referral laws to ensure that the standards and procedures reflect current positions and opinions.

In light of the documentation requirements faced by physician practices, it would be to the practice's benefit if its standards and procedures contained a section on the retention of compliance, business and medical records. These records primarily include documents relating to patient care and the practice's business activities. A physician practice's designated compliance contact could keep an updated binder or record of these documents, including information relating to compliance activities. The primary compliance documents that a practice would want to retain are those that relate to educational activities, internal investigations and internal audit results. We suggest that particular attention should be paid to documenting investigations of potential violations uncovered by the compliance program and the resulting remedial action. Although there is no requirement that the practice retain its compliance records, having all the relevant documentation relating to the practice's compliance efforts or handling of a particular problem can benefit the practice should it ever be questioned regarding those activities.

Physician practices that implement a compliance program might also want to provide for the development and implementation of a records retention system. This system would establish standards and procedures regarding the creation, distribution, retention, and destruction of documents. If the practice decides to design a record system, privacy concerns and Federal or State regulatory requirements should be taken into consideration. 34

While conducting its compliance activities, as well as its daily operations, a physician practice would be well advised, to the extent it is possible, to document its efforts to comply with applicable Federal health care program requirements. For example, if a physician practice requests advice from a Government agency (including a Medicare carrier) charged with administering a Federal health care program, it is to the benefit of the practice to document and retain a record of the request and any written or oral response (or nonresponse). This step is extremely important if the practice intends to rely on that response to guide it in future decisions, actions, or claim reimbursement requests or appeals.

In short, it is in the best interest of all physician practices, regardless of size, to have procedures to create and retain appropriate documentation. The following record retention guidelines are suggested:

• The length of time that a practice's records are to be retained can be specified in the physician practice's standards and procedures (Federal and State statutes should be consulted for specific time frames, if applicable);

• Medical records (if in the possession of the physician practice) need to be secured against loss, destruction, unauthorized access, unauthorized reproduction, corruption, or damage; and

• Standards and procedures can stipulate the disposition of medical records in the event the practice is sold or closed.

After the audits have been completed and the risk areas identified, ideally one member of the physician practice staff needs to accept the responsibility of developing a corrective action plan, if necessary, and oversee the practice's adherence to that plan. This person can either be in charge of all compliance activities for the practice or play a limited role merely to resolve the current issue. In a formalized institutional compliance program there is a compliance officer who is responsible for overseeing the implementation and day-to-day operations of the compliance program. However, the resource constraints of physician practices make it so that it is often impossible to designate one person to be in charge of compliance functions.

It is acceptable for a physician practice to designate more than one employee with compliance monitoring responsibility. In lieu of having a designated compliance officer, the physician practice could instead describe in its standards and procedures the compliance functions for which designated employees, known as “compliance contacts,” would be responsible. For example, one employee could be responsible for preparing written standards and procedures, while another could be responsible for conducting or arranging for periodic audits and ensuring that billing questions are answered. Therefore, the compliance-related responsibilities of the designated person or persons may be only a portion of his or her duties.

Another possibility is that one individual could serve as compliance officer for more than one entity. In situations where staffing limitations mandate that the practice cannot afford to designate a person(s) to oversee compliance activities, the practice could outsource all or part of the functions of a compliance officer to a third party, such as a consultant, PPMC, MSO, IPA or third-party billing company. However, if this role is outsourced, it is beneficial for the compliance officer to have sufficient interaction with the physician practice to be able to effectively understand the inner workings of the practice. For example, consultants that are not in close geographic proximity to a practice may not be effective compliance officers for the practice.

One suggestion for how to maintain continual interaction is for the practice to designate someone to serve as a liaison with the outsourced compliance officer. This would help ensure a strong tie between the compliance officer and the practice's daily operations. Outsourced compliance officers, who spend most of their time offsite, have certain limitations that a physician practice should consider before making such a critical decision. These limitations can include lack of understanding as to the inner workings of the practice, accessibility and possible conflicts of interest when one compliance officer is serving several practices.

If the physician practice decides to designate a particular person(s) to oversee all compliance activities, not just those in conjunction with the audit-related issue, the following is a list of suggested duties that the practice may want to assign to that person(s):

• Overseeing and monitoring the implementation of the compliance program;

• Establishing methods, such as periodic audits, to improve the practice's efficiency and quality of services, and to reduce the practice's vulnerability to fraud and abuse;

• Periodically revising the compliance program in light of changes in the needs of the practice or changes in the law and in the standards and procedures of Government and private payor health plans;

• Developing, coordinating and participating in a training program that focuses on the components of the compliance program, and seeks to ensure that training materials are appropriate;

• Ensuring that the HHS-OIG's List of Excluded Individuals and Entities, and the General Services Administration's (GSA's) List of Parties Debarred from Federal Programs have been checked with respect to all employees, medical staff and independent contractors;  35 and

• Investigating any report or allegation concerning possible unethical or improper business practices, and monitoring subsequent corrective action and/or compliance.

Each physician practice needs to assess its own practice situation and determine what best suits that practice in terms of compliance oversight.

Education is an important part of any compliance program and is the logical next step after problems have been identified and the practice has designated a person to oversee educational training. Ideally, education programs will be tailored to the physician practice's needs, specialty and size and will include both compliance and specific training.

There are three basic steps for setting up educational objectives:

• Determining who needs training (both in coding and billing and in compliance);

• Determining the type of training that best suits the practice's needs ( e.g. , seminars, in-service training, self-study or other programs); and

• Determining when and how often education is needed and how much each person should receive.

Training may be accomplished through a variety of means, including in-person training sessions ( i.e. , either on site or at outside seminars), distribution of newsletters, 36 or even a readily accessible office bulletin board. Regardless of the training modality used, a physician practice should ensure that the necessary education is communicated effectively and that the practice's employees come away from the training with a better understanding of the issues covered.

Under the direction of the designated compliance officer/contact, both initial and recurrent training in compliance is advisable, both with respect to the compliance program itself and applicable statutes and regulations. Suggestions for items to include in compliance training are: The operation and importance of the compliance program; the consequences of violating the standards and procedures set forth in the program; and the role of each employee in the operation of the compliance program.

There are two goals a practice should strive for when conducting compliance training: (1) All employees will receive training on how to perform their jobs in compliance with the standards of the practice and any applicable regulations; and (2) each employee will understand that compliance is a condition of continued employment. Compliance training focuses on explaining why the practice is developing and establishing a compliance program. The training should emphasize that following the standards and procedures will not get a practice employee in trouble, but violating the standards and procedures may subject the employee to disciplinary measures. It is advisable that new employees be trained on the compliance program as soon as possible after their start date and employees should receive refresher training on an annual basis or as appropriate.

Coding and billing training on the Federal health care program requirements may be necessary for certain members of the physician practice staff depending on their respective responsibilities. The OIG understands that most physician practices do not employ a professional coder and that the physician is often primarily responsible for all coding and billing. However, it is in the practice's best interest to ensure that individuals who are directly involved with billing, coding or other aspects of the Federal health care programs receive extensive education specific to that individual's responsibilities. Some examples of items that could be covered in coding and billing training include:

• Coding requirements;

• Claim development and submission processes;

• Signing a form for a physician without the physician's authorization;

• Proper documentation of services rendered;

• Proper billing standards and procedures and submission of accurate bills for services or items rendered to Federal health care program beneficiaries; and

• The legal sanctions for submitting deliberately false or reckless billings.

Training may be conducted either in-house or by an outside source. 37 Training at outside seminars, instead of internal programs and in-service sessions, may be an effective way to achieve the practice's training goals. In fact, many community colleges offer certificate or associate degree programs in billing and coding, and professional associations provide various kinds of continuing education and certification programs. Many carriers also offer billing training.

The physician practice may work with its third-party billing company, if one is used, to ensure that documentation is of a level that is adequate for the billing company to submit accurate claims on behalf of the physician practice. If it is not, these problem areas should also be covered in the training. In addition to the billing training, it is advisable for physician practices to maintain updated ICD-9, HCPCS and CPT manuals (in addition to the carrier bulletins construing those sources) and make them available to all employees involved in the billing process. Physician practices can also provide a source of continuous updates on current billing standards and procedures by making publications or Government documents that describe current billing policies available to its employees. 38

Physician practices do not have to provide separate education and training programs for the compliance and coding and billing training. All in-service training and continuing education can integrate compliance issues, as well as other core values adopted by the practice, such as quality improvement and improved patient service, into their curriculum.

There is no set formula for determining how often training sessions should occur. The OIG recommends that there be at least an annual training program for all individuals involved in the coding and billing aspects of the practice. 39 Ideally, new billing and coding employees will be trained as soon as possible after assuming their duties and will work under an experienced employee until their training has been completed.

When a practice determines it has detected a possible violation, the next step is to develop a corrective action plan and determine how to respond to the problem. Violations of a physician practice's compliance program, significant failures to comply with applicable Federal or State law, and other types of misconduct threaten a practice's status as a reliable, honest, and trustworthy provider of health care. Consequently, upon receipt of reports or reasonable indications of suspected noncompliance, it is important that the compliance contact or other practice employee look into the allegations to determine whether a significant violation of applicable law or the requirements of the compliance program has indeed occurred, and, if so, take decisive steps to correct the problem. 40 As appropriate, such steps may involve a corrective action plan, 41 the return of any overpayments, a report to the Government, 42 and/or a referral to law enforcement authorities.

One suggestion is that the practice, in developing its compliance program, develop its own set of monitors and warning indicators. These might include: Significant changes in the number and/or types of claim rejections and/or reductions; correspondence from the carriers and insurers challenging the medical necessity or validity of claims; illogical patterns or unusual changes in the pattern of CPT-4, HCPCS or ICD-9 code utilization; and high volumes of unusual charge or payment adjustment transactions. If any of these warning indicators become apparent, then it is recommended that the practice follow up on the issues. Subsequently, as appropriate, the compliance procedures of the practice may need to be changed to prevent the problem from recurring.

For potential criminal violations, a physician practice would be well advised in its compliance program procedures to include steps for prompt referral or disclosure to an appropriate Government authority or law enforcement agency. In regard to overpayment issues, it is advised that the physician practice take appropriate corrective action, including prompt identification and repayment of any overpayment to the affected payor.

It is also recommended that the compliance program provide for a full internal assessment of all reports of detected violations. If the physician practice ignores reports of possible fraudulent activity, it is undermining the very purpose it hoped to achieve by implementing a compliance program.

It is advised that the compliance program standards and procedures include provisions to ensure that a violation is not compounded once discovered. In instances involving individual misconduct, the standards and procedures might also advise as to whether the individuals involved in the violation either be retrained, disciplined, or, if appropriate, terminated. The physician practice may also prevent the compounding of the violation by conducting a review of all confirmed violations, and, if appropriate, self-reporting the violations to the applicable authority.

The physician practice may consider the fact that if a violation occurred and was not detected, its compliance program may require modification. Physician practices that detect violations could analyze the situation to determine whether a flaw in their compliance program failed to anticipate the detected problem, or whether the compliance program's procedures failed to prevent the violation. In any event, it is prudent, even absent the detection of any violations, for physician practices to periodically review and modify their compliance programs.

In order to prevent problems from occurring and to have a frank discussion of why the problem happened in the first place, physician practices need to have open lines of communication. Especially in a smaller practice, an open line of communication is an integral part of implementing a compliance program. Guidance previously issued by the OIG has encouraged the use of several forms of communication between the compliance officer/committee and provider personnel, many of which focus on formal processes and are more costly to implement ( e.g., hotlines and e-mail). However, the OIG recognizes that the nature of some physician practices is not as conducive to implementing these types of measures. The nature of a small physician practice dictates that such communication and information exchanges need to be conducted through a less formalized process than that which has been envisioned by prior OIG guidance.

In the small physician practice setting, the communication element may be met by implementing a clear “open door” policy between the physicians and compliance personnel and practice employees. This policy can be implemented in conjunction with less formal communication techniques, such as conspicuous notices posted in common areas and/or the development and placement of a compliance bulletin board where everyone in the practice can receive up-to-date compliance information. 43

A compliance program's system for meaningful and open communication can include the following:

• The requirement that employees report conduct that a reasonable person would, in good faith, believe to be erroneous or fraudulent;

• The creation of a user-friendly process (such as an anonymous drop box for larger practices) for effectively reporting erroneous or fraudulent conduct;

• Provisions in the standards and procedures that state that a failure to report erroneous or fraudulent conduct is a violation of the compliance program;

• The development of a simple and readily accessible procedure to process reports of erroneous or fraudulent conduct;

• If a billing company is used, communication to and from the billing company's compliance officer/contact and other responsible staff to coordinate billing and compliance activities of the practice and the billing company, respectively. Communication can include, as appropriate, lists of reported or identified concerns, initiation and the results of internal assessments, training needs, regulatory changes, and other operational and compliance matters;

• The utilization of a process that maintains the anonymity of the persons involved in the reported possible erroneous or fraudulent conduct and the person reporting the concern; and

• Provisions in the standards and procedures that there will be no retribution for reporting conduct that a reasonable person acting in good faith would have believed to be erroneous or fraudulent.

The OIG recognizes that protecting anonymity may not be feasible for small physician practices. However, the OIG believes all practice employees, when seeking answers to questions or reporting potential instances of erroneous or fraudulent conduct, should know to whom to turn for assistance in these matters and should be able to do so without fear of retribution. While the physician practice may strive to maintain the anonymity of an employee's identity, it also needs to make clear that there may be a point at which the individual's identity may become known or may have to be revealed in certain instances.

Finally, the last step that a physician practice may wish to take is to incorporate measures into its practice to ensure that practice employees understand the consequences if they behave in a non-compliant manner. An effective physician practice compliance program includes procedures for enforcing and disciplining individuals who violate the practice's compliance or other practice standards. Enforcement and disciplinary provisions are necessary to add credibility and integrity to a compliance program.

The OIG recommends that a physician practice's enforcement and disciplinary mechanisms ensure that violations of the practice's compliance policies will result in consistent and appropriate sanctions, including the possibility of termination, against the offending individual. At the same time, it is advisable that the practice's enforcement and disciplinary procedures be flexible enough to account for mitigating or aggravating circumstances. The procedures might also stipulate that individuals who fail to detect or report violations of the compliance program may also be subject to discipline. Disciplinary actions could include: Warnings (oral); reprimands (written); probation; demotion; temporary suspension; termination; restitution of damages; and referral for criminal prosecution. Inclusion of disciplinary guidelines in in-house training and procedure manuals is sufficient to meet the “well publicized” standard of this element.

It is suggested that any communication resulting in the finding of non-compliant conduct be documented in the compliance files by including the date of incident, name of the reporting party, name of the person responsible for taking action, and the follow-up action taken. Another suggestion is for physician practices to conduct checks to make sure all current and potential practice employees are not listed on the OIG or GSA lists of individuals excluded from participation in Federal health care or Government procurement programs. 44

A practice's commitment to compliance can best be assessed by the active application of compliance principles in the day-to-day operations of the practice. Compliance programs are not just written standards and procedures that sit on a shelf in the main office of a practice, but are an everyday part of the practice operations. It is by integrating the compliance program into the practice culture that the practice can best achieve maximum benefit from its compliance program.

Just as immunizations are given to patients to prevent them from becoming ill, physician practices may view the implementation of a voluntary compliance program as comparable to a form of preventive medicine for the practice. This voluntary compliance program guidance is intended to assist physician practices in developing and implementing internal controls and procedures that promote adherence to Federal health care program requirements.

As stated earlier, physician compliance programs do not need to be time or resource intensive and can be developed in a manner that best reflects the nature of each individual practice. Many of the recommendations set forth in this document are ones that many physician practices already have in place and are simply good business practices that can be adhered to with a reasonable amount of effort. By implementing an effective compliance program, appropriate for its size and resources, and making compliance principles an active part of the practice culture, a physician practice can help prevent and reduce erroneous or fraudulent conduct in its practice. These efforts can also streamline and improve the business operations within the practice and therefore innoculate itself against future problems.

Mandatory Guidelines for Federal Workplace Drug Testing were developed in accordance with Executive Order 12564 and section 503 of Public Law 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:

It is Service policy to have all lands within the National Wildlife Refuge System managed in accordance with an approved comprehensive conservation plan. The plan guides management decisions and identifies Refuge goals, objectives, and strategies for achieving Refuge purposes. Public input into this planning process is encouraged. The plan will provide other agencies and the public with a clear understanding of the desired future conditions of the Refuge and how the Service will implement management strategies. Some of the issues to be addressed in the plan include the following:

(a) Habitat management;

(b) Public use management;

(c) Wildlife population management;

(d) Wilderness management;

(e) Industrial facilities management; and

(f) Cultural resource identification and protection.

After the public scoping of issues, a decision will be made whether to prepare an environmental assessment or an environmental impact statement. If we decide to prepare an environmental impact statement, another notice of intent will be published announcing that decision. The environmental assessment or environmental impact statement will include several alternatives that address the issues and management strategies associated with these topics.

Crab Orchard National Wildlife Refuge was established on August 5, 1947, by Public law 80-361. This Act of Congress transferred certain Federal lands acquired in connection with the Crab Orchard Creek project and the Illinois Ordnance Plant to the Secretary of the Interior. This legislation mandated that these lands be administered by the Secretary through the Fish and Wildlife Service “for the conservation of wildlife, and for the development of the agricultural, recreational, industrial, and related purposes specified in this Act.”

The 43,890-acre Refuge contains three large man-made lakes and numerous small ponds totaling 9,000 acres, 26,000 acres of forest and brush land, 5,000 acres of cropland, 2,000 acres of grassland, and 2,000 acres of administrative lands. The Refuge supports an extensive variety of plant and animal species, hosts 1.2 million recreational visitors per year, provides facilities for industrial tenants, and sponsors cooperative farmers and permittee graziers. The 4,050-acre Crab Orchard Wilderness, the first wilderness are a designated in the State of Illinois, is within the Refuge.

The authority to issue this document is vested in the Secretary of the Interior by 5 U.S.C. 301 and the Act of August 14, 1914 (38 Stat. 583; 25 U.S.C. 385). The Secretary has delegated this authority to the Assistant Secretary—Indian Affairs pursuant to part 209 Departmental Manual, Chapter 8.1A and memorandum dated January 25, 1994, from Chief of Staff, Department of the Interior, to Assistant Secretaries, and Heads of Bureaus and Offices. The new rates are specified in the following schedule.

This notice is given in accordance with Section 171.1(e) and 171.1(g) of part 171, Subchapter H, Chapter 1, of Title 25 of the Code of Federal Regulations, which provides for the fixing and announcing the rates for annual operation and maintenance assessments and related information of Bureau of Indian Affairs irrigation projects.

The assessment rates are based on a prepared estimate of the cost of normal operation and maintenance of the irrigation project. Normal operation and maintenance means the expenses we incur to provide direct support or benefit to the project's activities for administration, operation, maintenance, and rehabilitation. We must include at least:

(a) Personnel salaries and benefits for the project engineer/manager and our employees under his management/control;

(b) Materials and supplies;

(c) Major and minor vehicle and equipment repairs;

(d) Equipment, including transportation, fuel, oil, grease, lease and replacement;

(e) Capitalization expenses;

(f) Acquisition expenses; and

(g) Other expenses we determine necessary to properly perform the activities and functions characteristic of an irrigation project.

The irrigation operation and maintenance assessments become due based on locally established payment requirements. No water shall be delivered to any of these lands until all irrigation charges have been paid.

Interest, penalty, and administrative fees will be assessed, where required by law, on all delinquent operation and maintenance assessment charges as prescribed in the Code of Federal Regulations, Title 4, Part 102, Federal Claims Collection Standards; and 42 BIAM Supplement 3, part 3.8 Debt Collection Procedures. Beginning 30 days after the due date, interest will be assessed at the rate of the current value of funds to the U.S. Treasury. An administrative fee of $12.50 will be assessed each time an effort is made to collect a delinquent debt; a penalty charge of 6 percent per year will be charged on delinquent debts over 90 days old and will accrue from the date the debt became delinquent. No water shall be delivered to any farm unit until all irrigation charges have been paid. Within 180 days a delinquent debt will be forwarded to the U.S. Treasury for further action in accordance with Debt Collection Improvement Act of 1996 (Public Law 104-134).

The following table illustrates the impact of the rate adjustment:

Regulatory Planning and Review (E.O. 12866): This rate adjustment is not a significant regulatory action and has been reviewed by the Office of Management and Budget under Executive Order 12866.

Regulatory Flexibility Act: This rate making is not a rule for the purposes of the Regulatory Flexibility Act because it is “a rule of particular applicability relating to rates” (5 U.S.C. § 601(2)).

Unfunded Mandates Reform Act: This rate adjustment imposes no unfunded mandates on any governmental or private entity and is in compliance with the provisions of the Unfunded Mandates Reform Act of 1995.

Takings Implication Assessment (E.O. 12630): The Department has determined that this rate adjustment does not have significant “takings” implications.

Federalism (E.O. 13132): The Department has determined that this rate adjustment does not have significant Federalism effects because it pertains solely to Federal-tribal relations and will not interfere with the roles, rights, and responsibilities of states.

Civil Justice Reform (E.O. 12988): The Department has certified to the Office of Management and Budget (OMB) that this rate adjustment meets the applicable standards provided in sections 3(a) and 3(b)(2) of Executive Order 12988.

Paperwork Reduction Act: This rate adjustment does not contain collections of information requiring approval under the Paperwork Reduction Act of 1995.

National Environmental Policy Act (NEPA): The Department has determined that this rate adjustment does not constitute a major Federal action significantly affecting the quality of the human environment and that no detailed statement is required under the National Environmental Policy Act of 1969.

Interested persons may submit written comments regarding the proposed rate adjustment to the location identified in the ADDRESSES section of this document. Our practice is to make comments, including names and home addresses of respondents, available for public review during regular business hours. Individual respondents may request confidentiality. If you wish to request that we consider withholding your name, street address, and other contact information (such as Internet address, FAX, or phone number) from public review or from disclosure under the Freedom of Information Act, you must state this prominently at the beginning of your comment. We will honor your request to the extent allowable by law. However, we will not consider anonymous comments. We will make all submissions from organizations or businesses, and from individuals identifying themselves as representatives or officials of organizations or businesses, available for public inspection in their entirety.