6–18–03 Vol. 68 No. 117 Wednesday June 18, 2003 Pages 36445–36742

6–18–03 Wednesday Vol. 68 No. 117 June 18, 2003

Pages 36445–36742

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1 II Federal Register / Vol. 68, No. 117 / Wednesday, June 18, 2003

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2 III

Contents Federal Register Vol. 68, No. 117

Wednesday, June 18, 2003

Agricultural Marketing Service Pesticides; tolerances in food, animal feeds, and raw PROPOSED RULES agricultural commodities: Soybean promotion, research, and consumer information: Azoxystrobin, 36480–36487 Small soybean producing States and regions; assessments Bacillus pumilus (strain QST2808), 36476–36480 reporting requirements, 36498–36499 Glyphosate, 36472–36476 Solid wastes: Agriculture Department Residential lead-based paint waste disposal; solid waste See Agricultural Marketing Service disposal facilities and municipal solid waste See Food and Nutrition Service landfills; classification and practices criteria, 36487– See Forest Service 36495 PROPOSED RULES Army Department Air quality implementation plans; approval and See Engineers Corps promulgation; various States: Missouri, 36527–36528 Centers for Disease Control and Prevention Solid wastes: NOTICES Hazardous waste; identification and listing— Agency information collection activities; proposals, Exclusions, 36528–36534 submissions, and approvals, 36565–36566 NOTICES Communicable disease control: Agency information collection activities; proposals, Monkeypox; embargo and prohibition on transportation submissions, and approvals, 36545–36546 of all rodents from Africa, 36566–36567 Reports and guidance documents; availability, etc.: World Trade Center disaster— Coast Guard Exposure and human health evaluation of airborne RULES pollution; technical peer review meeting, 36546– Ports and waterways safety: 36547 Colorado River, NV; safety zone, 36466–36467 Water pollution control: NOTICES Total maximum daily loads— Agency information collection activities; proposals, Arkansas; state-wide waters list, 36547 submissions, and approvals, 36571–36572 Water supply: Commerce Department Public water supply supervision program— See National Oceanic and Atmospheric Administration Louisiana, 36548

Community Development Financial Institutions Fund Executive Office of the President NOTICES See Presidential Documents Agency information collection activities; proposals, Export-Import Bank submissions, and approvals, 36631–36632 NOTICES Consumer Product Safety Commission Egypt; equipment and other goods and services to produce NOTICES anhydrous ammonia from natural gas; finance Meetings; Sunshine Act, 36545 application, 36548 Mexico; equipment and other goods and services to Copyright Office, Library of Congress produce non-automotive flat glass; finance application, RULES 36548 Copyright Arbitration Royalty Panel rules and procedures: Digital performance of sound recordings; reasonable rates Federal Aviation Administration and terms determination, 36469–36470 RULES Airworthiness directives: Defense Department Aerospatiale, 36451–36452 See Engineers Corps BAE Systems (Operations) Ltd., 36452–36454 See Navy Department Empresa Brasileira de Aeronautica, S. A. (EMBRAER), 36454–36455 Engineers Corps General Electric Co., 36455–36458 RULES Airworthiness standards: Natural disaster procedures; preparedness, response, and Special conditions— recovery activities Boeing Model 747SP, 747-100, 747-200B, -200C, and Correction, 36467–36469 -200F series airplanes, 36449–36451 PROPOSED RULES Environmental Protection Agency Airworthiness directives: RULES Aerospatiale, 36525–36526 Air quality implementation plans; approval and Airbus, 36504–36506 promulgation; various States: Boeing, 36499–36502, 36506–36513, 36515–36518 Missouri, 36470–36472 Bombardier, 36513–36515

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Learjet, 36502–36504 Food and Drug Administration McDonnell Douglas, 36518–36525 RULES NOTICES Human drugs: Advisory circulars; availability, etc.: Abbreviated new drug applications certifying that patent Aircraft engines; turbine rotor strength requirements, claiming drug is invalid or will not be infringed; 36623 patent listing requirements and 30 month stays, 36675–36712 Federal Communications Commission PROPOSED RULES NOTICES Human drugs and biological products: Common carrier services: Pre- and postmarketing safety reporting requirements, Telecommunication carrier eligibility designation 36527 petitions— NOTICES ALLTELL Communciations, Inc.; Alabama service area; Communicable disease control: comment request, 36549–36550 Monkeypox; embargo and prohibition on transportation ALLTELL Communciations, Inc.; Virginia service area; of all rodents from Africa, 36566–36567 comment request, 36548–36549 Food for human consumption: Identity standards deviation; market testing permits— Federal Election Commission Chiquita Processed Foods, LLC and Crown Cork & Seal NOTICES Co.; canned asparagus, 36567 Meetings; Sunshine Act, 36550 Food and Nutrition Service Federal Maritime Commission NOTICES NOTICES Agency information collection activities; proposals, Agreements filed, etc., 36550–36551 submissions, and approvals, 36536–36537 Ocean transportation intermediary licenses: American Logistics & Purchasing Services, Ltd., et al., Forest Service 36551–36552 NOTICES Martin Strauss Air Freight Corp. et al., 36552 Agency information collection activities; proposals, Speedtrans International, Inc., et al., 36552 submissions, and approvals, 36537–36538 Federal Railroad Administration Health and Human Services Department NOTICES See Centers for Disease Control and Prevention Exemption petitions, etc.: See Food and Drug Administration Canadian National Railway, 36623–36624 See National Institutes of Health Canadian Pacific Railway, 36624–36625 See Substance Abuse and Mental Health Services Dakota, Minnesota & Eastern Railroad, 36625 Administration Eastern Maine Railway, 36625–36626 NOTICES National Railroad Passenger Corp., 36626–36627 Grants and cooperative agreements; availability, etc.: Traffic control systems; discontinuance or modification: State innovation grants, 36560–36565 Burlington Northern & Santa Fe Railway, 36627–36628 CSX Transportation, Inc., 36628–36629 Homeland Security Department Norfolk Southern Corp., 36629 See Coast Guard Federal Reserve System NOTICES Housing and Urban Development Department Banks and bank holding companies: NOTICES Change in bank control, 36552 Agency information collection activities; proposals, Formations, acquisitions, and mergers, 36552–36553 submissions, and approvals, 36572–36578 Permissible nonbanking activities, 36553 Meetings; Sunshine Act, 36553 Interior Department See Land Management Bureau Federal Retirement Thrift Investment Board See National Park Service NOTICES NOTICES Meetings; Sunshine Act, 36553 Central Arizona Project, AZ; water allocations and service contracting, 36578–36579 Federal Trade Commission RULES Internal Revenue Service Appliances, consumer; energy consumption and water use NOTICES information in labeling and advertising: Agency information collection activities; proposals, Comparability ranges— submissions, and approvals, 36632–36633 Clothes washers, 36458–36466 NOTICES Labor Department Premerger notification waiting periods; early terminations, NOTICES 36553–36555 Agency information collection activities; proposals, Prohibited trade practices: submissions, and approvals, 36584–36586 Anesthesia Service Medical Group, Inc., 36557–36558 Grants and cooperative agreements; availability, etc.: Grossmont Anesthesia Services Medical Group, Inc., Women in Apprenticeship and Nontraditional 36558–36560 Occupations Program, 36586–36601

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Land Management Bureau Navy Department NOTICES NOTICES Meetings: Inventions, Government-owned; availability for licensing, Resource Advisory Committees— 36545 Medford District, 36580 Resource Advisory Councils— Nuclear Regulatory Commission Eastern Montana, 36579–36580 RULES Survey plat filings: Fee schedules revision; 94% fee recovery (2003 FY), Wyoming, 36580–36581 36713–36741 NOTICES Library of Congress Agency information collection activities; proposals, See Copyright Office, Library of Congress submissions, and approvals, 36601 Environmental statements; availability, etc.: Maritime Administration Aventis Pharmaceuticals, Inc., 36601–36602 NOTICES Agency information collection activities; proposals, Presidential Documents submissions, and approvals, 36629 PROCLAMATIONS Special observances: National Highway Traffic Safety Administration Father’s Day (Proc. 7686), 36447–36448 PROPOSED RULES National Homeownership Month (Proc. 7685), 36445– Motor vehicle safety standards: 36446 Vehicle compatibility and roll over mitigation; safety Securities and Exchange Commission reports availability, 36534–36535 RULES Securities, etc.: National Institutes of Health Sarbanes-Oxley Act of 2002; implementation— NOTICES Exchange Act periodic reports; inclusion of Agency information collection activities; proposals, management’s report on internal control over submissions, and approvals, 36567–36568 financial reporting and certification, 36635–36673 Meetings: NOTICES National Human Genome Research Institute, 36568 Agency information collection activities; proposals, National Institute of Child Health and Human submissions, and approvals, 36602 Development, 36568–36569 Investment Company Act of 1940: National Institute of Diabetes and Digestive and Kidney Exemption applications— Diseases, 36570 American Performance Funds et al., 36611–36614 National Institute of General Medical Sciences, 36568– Dresdener Bank AG et al., 36602–36607 36570 Franklin Gold and Precious Metals Fund et al., 36607– National Institute of Mental Health, 36569 36611 National Institute on Drug Abuse, 36570 Securities, etc.: Sarbanes-Oxley Act of 2002; implementation— National Oceanic and Atmospheric Administration Proposed bylaws and amendment; comment request, NOTICES 36614–36616 Agency information collection activities; proposals, Self-regulatory organizations; proposed rule changes: submissions, and approvals, 36538–36539 American Stock Exchange LLC, 36616–36621 Environmental statements; notice of intent: Pacific Exchange, Inc., 36621–36622 Northern fur seals; effects of subsistance taking on Pribilof Islands, AK, 36539–36540 Small Business Administration Marine mammals: NOTICES Incidental taking; authorization letters, etc.— Disaster loan areas: EnCana Oil & Gas (USA) Inc.; steel drilling caisson Tennessee, 36622 move from Cross Island, AK through Beaufort Sea Virginia, 36622–36623 to Hershel Island, Yukon Territory, 36542–36545 Vandenberg Air Force Base, CA; harbor activities State Department related to Delta IV/Evolved Expendable Launch NOTICES Vehicle; Pacific harbor seals, etc., 36540–36542 Meetings: International Telecommunication Advisory Committee, National Park Service 36623 NOTICES Environmental statements; availability, etc.: Substance Abuse and Mental Health Services Colonial National Historical Park, Jamestown Unit, VA, Administration and Jamestown National Historic Site, VA, 36581 NOTICES Meetings: Meetings: Chesapeake and Ohio Canal National Historical Park Mental Health Services Center National Advisory Advisory Commission, 36581–36582 Council, 36571 National Register of Historic Places: Pending nominations, 36582–36583 Transportation Department Realty actions; sales, leases, etc.: See Federal Aviation Administration Maryland, 36583–36584 See Federal Railroad Administration

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See Maritime Administration Part III See National Highway Traffic Safety Administration Health and Human Services Department, Food and Drug RULES Administration, 36675–36712 Organization, functions, and authority delegations: Maritime Administrator, 36496–36497 Part IV Treasury Department Nuclear Regulatory Commission, 36713–36741 See Community Development Financial Institutions Fund See Internal Revenue Service NOTICES Agency information collection activities; proposals, Reader Aids submissions, and approvals, 36630–36631 Consult the Reader Aids section at the end of this issue for United States Postal Service, President’s Commission; phone numbers, online resources, finding aids, reminders, comment request, 36631 and notice of recently enacted public laws. To subscribe to the Federal Register Table of Contents Separate Parts In This Issue LISTSERV electronic mailing list, go to http:// listserv.access.gpo.gov and select Online mailing list Part II archives, FEDREGTOC-L, Join or leave the list (or change Securities and Exchange Commission, 36635–36673 settings); then follow the instructions.

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CFR PARTS AFFECTED IN THIS ISSUE

A cumulative list of the parts affected this month can be found in the Reader Aids section at the end of this issue.

3 CFR Proclamations: 7685...... 36445 7686...... 36447 7 CFR Proposed Rules: 1220...... 36498 10 CFR 170...... 36714 171...... 36714 14 CFR 25...... 36449 39 (4 documents) ...... 36451, 36452, 36454, 36455 Proposed Rules: 39 (11 documents) ...... 36499, 36502, 36504, 36506, 36510, 36513, 36515, 36518, 36520, 36523, 36525 16 CFR 305...... 36458 17 CFR 210...... 36636 228...... 36636 229...... 36636 240...... 36636 249...... 36636 270...... 36636 274...... 36636 21 CFR 314...... 36676 Proposed Rules: 310...... 36527 312...... 36527 314...... 36527 320...... 36527 600...... 36527 601...... 36527 606...... 36527 33 CFR 165...... 36466 203...... 36467 37 CFR 260...... 36469 40 CFR 52...... 36470 180 (3 documents) ...... 36472, 36476, 36480 257...... 36487 258...... 36487 Proposed Rules: 52...... 36527 261...... 36528 49 CFR 1...... 36496 Proposed Rules: 571...... 36534

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Federal Register Presidential Documents Vol. 68, No. 117

Wednesday, June 18, 2003

Title 3— Proclamation 7685 of June 13, 2003

The President National Homeownership Month, 2003

By the President of the United States of America

A Proclamation

Homeownership is more than just a symbol of the American Dream; it is an important part of our way of life. Core American values of individuality, thrift, responsibility, and self-reliance are embodied in homeownership. I am committed to helping more families know the security and sense of pride that comes with owning a home. The Department of Housing and Urban Development is leading an Adminis- tration-wide effort to bring new tools and resources to would-be homeowners. We are providing financial assistance to qualified families through the Amer- ican Dream Downpayment Fund, funding educational programs that stress financial literacy, and offering a compassionate hand to those who dream of moving from subsidized housing into homeownership. And through the Self-Help Homeownership Opportunity Program, my Administration partners with nonprofit organizations that offer homeownership opportunities to families willing to contribute their skills and labor to help build a home of their own. We are also proposing ways to make it easier to shop for a mortgage and to make mortgages available to more families through the Federal Housing Administration. Today, the United States is fortunate in that our homeownership rate is at an all-time high, and low interest rates continue to encourage millions of Americans to become first-time homeowners. Although a record number of Americans own their own homes, we continue to see a gap between the homeownership rates of minorities and nonminorities. By a significant margin, minority families are less likely to own their own homes. Therefore, I have called upon the entire housing industry to join with my Administration to expand minority homeownership across the Nation. Our goal is to help at least 5.5 million minority families become homeowners by the end of this decade, and our Blueprint for the American Dream Partnership is taking bold steps to make this a reality. Across our Nation, every citizen, regardless of race, creed, color, or place of birth, should have the opportunity to become a homeowner. Homeowner- ship represents a pathway to pride and prosperity for many families, encourages values of responsibility and sacrifice, creates stability for neighborhoods and communities, and generates economic growth that helps strengthen the entire Nation. NOW, THEREFORE, I, GEORGE W. BUSH, President of the United States of America, by virtue of the authority vested in me by the Constitution and laws of the United States, do hereby proclaim June 2003 as National Homeownership Month. I call upon the people of the United States to join me in recognizing the importance of offering every American the opportunity to realize their dream of homeownership and to help work towards making that dream a reality.

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IN WITNESS WHEREOF, I have hereunto set my hand this thirteenth day of June, in the year of our Lord two thousand three, and of the Independence of the United States of America the two hundred and twenty-seventh. W

[FR Doc. 03–15539 Filed 6–17–03; 8:45 am] Billing code 3195–01–P

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Proclamation 7686 of June 13, 2003

Father’s Day, 2003

By the President of the United States of America

A Proclamation

Fatherhood is one of life’s most challenging yet fulfilling endeavors. On Father’s Day, we honor America’s fathers and express our appreciation for all they do to help build a strong foundation for our children and our Nation. We also reaffirm our commitment to supporting fathers and encouraging responsible fatherhood in our society. Fathers have indispensable roles to play in the lives of their children: provider, protector, nurturer, teacher, and friend. Every caring father uncondi- tionally loves his sons and daughters and strives for the best for his children in the future. In seeking to give their children the opportunity to succeed, fathers offer needed strength, guidance, and discipline. Fathers teach their children many basic things in life: how to read a book, throw a ball, tie a necktie, ride a bike, or drive a car. More importantly, they also help instill time- honored values in their children, such as hard work, respect, honesty, and good citizenship. Through their words, actions, and sacrifices, fathers play an important role in shaping the characters of their sons and daughters. The time and attention that a father gives to a child is irreplaceable— there is no substitute for the involvement and commitment of a responsible father. Not only are fathers essential to the healthy development of children, they also influence the strength of families and the stability of communities. For this reason, our Government is working to help fathers succeed in this challenging, but life-affirming, role. Over the last 2 years, my Administra- tion has taken important steps to promote responsible fatherhood and encourage community-based initiatives that help them fulfill their important roles. We are working to provide funds for healthy marriage and parenting education and for community mentoring programs to help fathers become more engaged and involved in their children’s lives. This Father’s Day, we recognize the many fathers who are heroes and role models for their children, and we encourage more men to fulfill this responsibility by loving their sons and daughters with all their heart and demonstrating this love daily. By working together to encourage America’s fathers, we can strengthen our society and help ensure the well-being of all our children. NOW, THEREFORE, I, GEORGE W. BUSH, President of the United States of America, in accordance with a joint resolution of the Congress approved April 24, 1972, as amended (36 U.S.C. 109), do hereby proclaim June 15, 2003, as Father’s Day. I encourage all Americans to express love, admiration, and thanks to their fathers for their contributions to our lives and to society. I direct the appropriate officials of the Government to display the flag of the United States on all Government buildings on this day. I also call upon State and local governments and citizens to observe this day with appropriate programs, ceremonies, and activities.

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[FR Doc. 03–15540 Filed 6–17–03; 8:45 am] Billing code 3195–01–P

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Rules and Regulations Federal Register Vol. 68, No. 117

Wednesday, June 18, 2003

This section of the FEDERAL REGISTER SW., Renton, Washington 98055–4056; If you want the FAA to acknowledge contains regulatory documents having general or delivered in duplicate to the receipt of your comments on these applicability and legal effect, most of which Transport Airplane Directorate at the special conditions, include with your are keyed to and codified in the Code of above address. All comments must be comments a pre-addressed, stamped Federal Regulations, which is published under marked: Docket No. NM257. postcard on which the docket number 50 titles pursuant to 44 U.S.C. 1510. FOR FURTHER INFORMATION CONTACT: Greg appears. We will stamp the date on the The Code of Federal Regulations is sold by Dunn, FAA, Airplane and Flight Crew postcard and mail it back to you. the Superintendent of Documents. Prices of Branch, ANM–111, Transport Airplane Background new books are listed in the first FEDERAL Directorate, Aircraft Certification REGISTER issue of each week. On May 1, 2002, J.R.G Design Service, 1601 Lind Avenue, SW., submitted an application to the New Renton, Washington 98055–4056; York Aircraft Certification Office for a DEPARTMENT OF TRANSPORTATION telephone (425) 227–2799; facsimile Supplemental Type Certificate (STC). (425) 227–1149. The Boeing Model 747SP series; 747– Federal Aviation Administration SUPPLEMENTARY INFORMATION: 100 series; and 747–200B, –200C, and –200F series airplanes are being Comments Invited 14 CFR Part 25 modified for use by a head of state; they [Docket No. NM257; Special Conditions No. The FAA has determined that notice are non N-registered airplanes operating 25–238–SC] and opportunity for public comment in under part 91. This project involves accordance with 14 CFR 11.38 are replacing round dial displays in the Special Conditions: Boeing Model unnecessary, because the FAA has cockpit with four EFIS displays. The 747SP Series; 747–100 Series; and provided previous opportunities to EFIS upgrade is for multiple airplane 747–200B, –200C, and –200F Series comment on substantially identical installations. These systems may be Airplanes; High-Intensity Fields (HIRF) special conditions and has fully vulnerable to HIRF external to the considered and addressed all the airplane. AGENCY: Federal Aviation substantive comments received. Based Administration (FAA), DOT. Type Certification Basis on a review of the comment history and ACTION: Final special conditions; request the comment resolution, the FAA is Under the provisions of 14 CFR 21.17, for comments satisfied that new comments are J.R.G Design, Inc. must show that Boeing Model 747SP series; 747–100 SUMMARY: These special conditions are unlikely. The FAA, therefore, finds that series; and 747–200B, –200C, and –200F issued for Boeing Model 747SP series; good cause exists for making these series airplanes meet the applicable 747–100 series; and 747–200B, –200C, special conditions effective upon provisions in effect on the date of and –200F series airplanes. These issuance. application for the supplemental type airplanes will have a novel or unusual However, the FAA invites interested certificate or applicable provisions of 14 design feature when compared to the persons to participate in this rulemaking CFR part 25, as amended by state of technology envisioned in the by submitting written comments, data, Amendments 21–1 through 25–106, for airworthiness standards for transport or views. The most helpful comments areas affected by the change to the category airplanes. The airplane reference a specific portion of the greatest extent feasible. If the modification includes the installation of special conditions, explain the reason Administrator finds that the applicable an Electronic Flight Instrument System for any recommended change, and airworthiness regulations (i.e., part 25 as (EFIS), which performs critical include supporting data. We ask that amended) do not contain adequate or functions. The applicable airworthiness you send us two copies of written appropriate safety standards for Boeing regulations do not contain adequate or comments. Model 747SP series; 747–100 series; and appropriate safety standards for the We will file in the docket all 747–200 series airplanes because of a protection of this system from the comments we receive, as well as a novel or unusual design feature, special effects of high-intensity-radiated fields report summarizing each substantive conditions are prescribed under the (HIRF). These special conditions public contact with FAA personnel provisions of § 21.16. contain the additional safety standards concerning these special conditions. In addition to the applicable that the Administrator considers The docket is available for public airworthiness regulations and special necessary to establish a level of safety inspection before and after the comment conditions, Boeing Model 747SP series; equivalent to that established by the closing date. If you wish to review the 747–100 series; and 747–200B, –200C, existing airworthiness standards. docket in person, go to the address in and –200F series airplanes must comply EFFECTIVE DATE: The effective date of the ADDRESSES section of this preamble with the fuel vent and exhaust emission these special conditions is June 10, between 7:30 a.m. and 4 p.m., Monday requirements of 14 CFR part 34 and the 2003. Comments must be received on or through Friday, except Federal holidays. noise certification requirements of 14 before July 18, 2003. We will consider all comments we CFR part 36, and the FAA must issue a ADDRESSES: Comments on these special receive on or before the closing date for finding of regulatory adequacy pursuant conditions may be mailed in duplicate comments. We will consider comments to § 611 of Public Law 92–574, the to: Federal Aviation Administration, filed late if it is possible to do so ‘‘Noise Control Act of 1972.’’ Transport Airplane Directorate, without incurring expense or delay. We Special conditions, as defined in 14 Attention: Rules Docket (ANM–113), may change these special conditions CFR 11.19, are issued in accordance Docket No. NM257, 1601 Lind Avenue, based on the comments we receive. with § 11.38 and become part of the type

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certification basis in accordance with uncertainty concerning the effectiveness apply to those airplanes as well, under § 21.101(a)(2). of airframe shielding for HIRF. the provisions of § 21.101(a)(1), Special conditions are initially Furthermore, coupling of Amendment 21–69, effective September applicable to the model for which they electromagnetic energy to cockpit- 16, 1991. are issued. Should the type certificate installed equipment through the cockpit for that model be amended later to window apertures is undefined. Based Conclusion include any other model that on surveys and analysis of existing HIRF This action affects only certain novel incorporates the same novel or unusual emitters, an adequate level of protection or unusual design features on Boeing design feature, these special conditions exists when compliance with the HIRF Model 747SP series; 747–100 series; and would also apply to the other model protection special condition is shown 747–200B, –200C, and –200F series under the provisions of § 21.101(a)(1), with either paragraph 1 or 2 below: Amendment 21–69, effective September 1. A minimum threat of 100 volts rms airplanes. It is not a rule of general 16, 1991. (root-mean-square) per meter electric applicability and affects only the field strength from 10 KHz to 18 GHz. applicant which applied to the FAA for Novel or Unusual Design Features a. The threat must be applied to the approval of these features on the As noted earlier, Boeing Model 747SP system elements and their associated airplane. The FAA has determined that series; 747–100 series; and 747–200B, wiring harnesses without the benefit of notice and opportunity for public –200C, and –200F series airplanes will airframe shielding. comment are unnecessary, because the incorporate four EFIS displays (two for b. Demonstration of this level of FAA has provided previous each pilot) that will perform critical protection is established through system opportunities to comment on functions. These systems may be tests and analysis. substantially identical special vulnerable to HIRF external to the 2. A threat external to the airframe of conditions and has fully considered and airplane. The current airworthiness the field strengths identified in the table addressed all the substantive comments standards of part 25 do not contain below for the frequency ranges received. The FAA is satisfied that new adequate or appropriate safety standards indicated. Both peak and average field comments are unlikely and finds, strength components from the table are for the protection of this equipment therefore, that good cause exists for from the adverse effects of HIRF. to be demonstrated. making these special conditions Accordingly, these systems are effective upon issuance. considered to be novel or unusual Field strength (volts per meter) designs. Frequency List of Subjects in 14 CFR Part 25 Peak Average Discussion Aircraft, Aviation safety, Reporting There is no specific regulation that 10 kHz–100 kHz ...... 50 50 and recordkeeping requirements. addresses protection requirements for 100 kHz–500 kHz ..... 50 50 The authority citation for these electrical and electronic systems from 500 kHz–2 MHz ...... 50 50 HIRF. Increased power levels from 2 MHz–30 MHz ...... 100 100 special conditions is as follows: ground-based radio transmitters and the 30 MHzs–70 MHz ..... 50 50 Authority: 49 U.S.C. 106(g), 40113, 44701, growing use of sensitive avionics/ 70 MHz–100 MHz ..... 50 50 44702, 44704. 100 MHz–200 MHz ... 100 100 electronics and electrical systems to 200 MHz–400 MHz ... 100 100 The Special Conditions command and control airplanes have 400 MHz–700 MHz ... 700 50 made it necessary to provide adequate 700 MHz–1 GHz ...... 700 100 Accordingly, pursuant to the protection. 1 GHz–2 GHz ...... 2000 200 authority delegated to me by the To ensure that a level of safety is 2 GHz–4 GHz ...... 3000 200 Administrator, the following special 4 GHz–6GHz ...... 3000 200 achieved equivalent to that intended by conditions are issued as part of the type the regulations incorporated by 6 GHz–8 GHz ...... 1000 200 certification basis for Boeing Model reference, special conditions are needed 8 GHz–12 GHz ...... 3000 300 12 GHz–18 GHz ...... 2000 200 747SP series; 747–100 series; and 747– for Boeing Model 747SP series; 747–100 18 GHz–40 GHz ...... 600 200 series; and 747–200B, –200C, and –200F 200B, –200C, and –200F series series airplanes. These special Note.—The field strengths are expressed in airplanes. conditions require that avionic/ terms of peak of the root-mean-square (rms) 1. Protection From Unwanted Effects over the complete modulation period. electronic and electrical systems that of High-Intensity Radiated Fields perform critical functions be designed The threat levels identified above are (HIRF). Each electrical and electronic and installed to preclude component the result of an FAA review of existing system that performs critical functions damage and interruption of function studies on the subject of HIRF, in light must be designed and installed to due to both the direct and indirect of the ongoing work of the ensure that the operation and effects of HIRF. Electromagnetic Effects Harmonization operational capability of these systems Working Group of the Aviation High-Intensity Radiated Fields (HIRF) to perform critical functions are not Rulemaking Advisory Committee. adversely affected when the airplane is With the trend toward increased exposed to high-intensity radiated power levels from ground-based Applicability fields. transmitters and the advent of space and As discussed above, these special satellite communications, coupled with conditions are applicable to Boeing 2. For the purpose of these special electronic command and control of the Model 747SP series; 747–110 series; and conditions, the following definition airplane, the immunity of critical 747–200B, –200C, and –200F series applies: Critical Functions: Functions avionic/electronic and electrical airplanes. Should J.R.G. Design apply at whose failure would contribute to or systems to HIRF must be established. a later date for a type certificate change cause a failure condition that would It is not possible to precisely define for these airplane models incorporating prevent the continued safe flight and the HIRF to which the airplane will be the same novel or unusual design landing of the airplane. exposed in service. There is also feature, these special conditions would

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Issued in Renton, Washington on June 10, SUPPLEMENTARY INFORMATION: A operator has yet accomplished any of 2003. proposal to amend part 39 of the Federal the requirements of this AD action, and Kalene C. Yanamura, Aviation Regulations (14 CFR part 39) to that no operator would accomplish Acting Manager, Transport Airplane include an airworthiness directive (AD) those actions in the future if this AD Directorate, Aircraft Certification Service. that is applicable to certain Aerospatiale were not adopted. The cost impact [FR Doc. 03–15401 Filed 6–17–03; 8:45 am] Model ATR42–200, –300, –320, and figures discussed in AD rulemaking BILLING CODE 4910–13–M –500 series airplanes; and Model actions represent only the time ATR72–102, –202, –212, and 212A necessary to perform the specific actions series airplanes was published in the actually required by the AD. These DEPARTMENT OF TRANSPORTATION Federal Register on February 21, 2003 figures typically do not include (68 FR 8477). That action proposed to incidental costs, such as the time Federal Aviation Administration require modification of the flight required to gain access and close up, attendant’s seat located in the front of planning time, or time necessitated by 14 CFR Part 39 the cabin, and follow-on actions. other administrative actions. [Docket No. 2002–NM–331–AD; Amendment Comments Regulatory Impact 39–13195; AD 2003–12–10] Interested persons have been afforded The regulations adopted herein will RIN 2120–AA64 an opportunity to participate in the not have a substantial direct effect on the States, on the relationship between Airworthiness Directives; Aerospatiale making of this amendment. No the national Government and the States, Model ATR42–200, –300, –320, and comments were submitted in response or on the distribution of power and –500 Series Airplanes; and Model to the proposal or the FAA’s responsibilities among the various ATR72–102, –202, –212, and 212A determination of the cost to the public. levels of government. Therefore, it is Series Airplanes Clarification of Applicability determined that this final rule does not AGENCY: Federal Aviation We have revised the applicability have federalism implications under Administration, DOT. listed in Table 1 in this final rule to Executive Order 13132. ACTION: Final rule. more clearly identify those airplanes For the reasons discussed above, I affected by this AD. certify that this action (1) is not a SUMMARY: This amendment adopts a ‘‘significant regulatory action’’ under Conclusion new airworthiness directive (AD), Executive Order 12866; (2) is not a applicable to certain Aerospatiale Model After careful review of the available ‘‘significant rule’’ under DOT ATR42–200, –300, –320, and –500 series data, we have determined that air safety Regulatory Policies and Procedures (44 airplanes; and Model ATR72–102, –202, and the public interest require the FR 11034, February 26, 1979); and (3) –212, and 212A series airplanes; that adoption of the rule with the change will not have a significant economic requires modification of the flight described previously. The FAA has impact, positive or negative, on a attendant’s seat located in the front of determined that this change will neither substantial number of small entities the cabin, and follow-on actions. This increase the economic burden on any under the criteria of the Regulatory action is necessary to prevent release of operator nor increase the scope of the Flexibility Act. A final evaluation has the forward flight attendant’s shoulder AD. been prepared for this action and it is restraint harness, which could result in Changes to 14 CFR Part 39/Effect on the contained in the Rules Docket. A copy injury to the flight attendant in case of AD of it may be obtained from the Rules turbulence. This action is intended to Docket at the location provided under address the identified unsafe condition. On July 10, 2002, the FAA issued a the caption ADDRESSES. DATES: new version of 14 CFR part 39 (67 FR Effective July 23, 2003. List of Subjects in 14 CFR Part 39 The incorporation by reference of 47997, July 22, 2002), which governs the certain publications listed in the FAA’s airworthiness directives system. Air transportation, Aircraft, Aviation regulations is approved by the Director The regulation now includes material safety, Incorporation by reference, of the Federal Register as of July 23, that relates to altered products, special Safety. 2003. flight permits, and alternative methods of compliance. However, for clarity and Adoption of the Amendment ADDRESSES: The service information consistency in this final rule, we have ■ Accordingly, pursuant to the authority referenced in this AD may be obtained retained the language of the NPRM delegated to me by the Administrator, from Aerospatiale, 316 Route de regarding that material. the Federal Aviation Administration Bayonne, 31060 Toulouse, Cedex 03, amends part 39 of the Federal Aviation France. This information may be Cost Impact Regulations (14 CFR part 39) as follows: examined at the Federal Aviation The FAA estimates that Administration (FAA), Transport approximately 80 airplanes of U.S. PART 39—AIRWORTHINESS Airplane Directorate, Rules Docket, registry will be affected by this AD, that DIRECTIVES 1601 Lind Avenue, SW., Renton, it will take approximately 1 work hour Washington; or at the Office of the per airplane to accomplish the required ■ 1. The authority citation for part 39 Federal Register, 800 North Capitol actions, and that the average labor rate continues to read as follows: Street, NW., suite 700, Washington, DC. is $60 per work hour. Required parts Authority: 49 U.S.C. 106(g), 40113, 44701. FOR FURTHER INFORMATION CONTACT: Dan will cost approximately $1,786 per Rodina, Aerospace Engineer, airplane. Based on these figures, the cost § 39.13 [Amended] International Branch, ANM–116, FAA, impact of the AD on U.S. operators is ■ 2. Section 39.13 is amended by adding Transport Airplane Directorate, 1601 estimated to be $147,680, or $1,846 per the following new airworthiness Lind Avenue, SW., Renton, Washington airplane. directive: 98055–4056; telephone (425) 227–2125; The cost impact figure discussed 2003–12–10 Aerospatiale: Amendment 39– fax (425) 227–1149. above is based on assumptions that no 13195. Docket 2002–NM–331–AD.

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Applicability: Airplanes listed in the following table, certificated in any category:

TABLE 1.—APPLICABILITY

On which these modifications have been On which these modifications have not been Airplane models— installed— installed—

ATR42–200, –300, and -–320 series airplanes 0384, 1685, or 1991; or modifications per 5328 per ATR Service Bulletin ATR42–25– Avions de Transport Regional (ATR) Serv- 0141, 0619, or 8023 per ATR Service Bul- ice Bulletins ATR42–25–0082, ATR42–98– letin ATR42–98–025A 331A, or ATR42–98–409C. ATR42–500 series airplanes ...... 4181 or 5042 ...... 5301 per ATR Service Bulletin ATR42–98– 524D, or 5328 per ATR Service Bulletin ATR42–25–0141 ATR72–102, –202, –212, and –212A series (No applicable modification) ...... 5328 (replacement of the inertia-reel harness airplanes. with a fixed harness) per ATR Service Bul- letin ATR72–25–1082

Note 1: This AD applies to each airplane Service Bulletin 138–25–008, dated Note 4: The subject of this AD is addressed identified in the preceding applicability September 18, 2002. in French airworthiness directive 2002– provision, regardless of whether it has been Note 2: ATR Service Bulletins ATR42–25– 539(B), dated October 30, 2002. otherwise modified, altered, or repaired in 0141 and ATR72–25–1082 reference SICMA the area subject to the requirements of this Service Bulletin 138–25–008 as an additional Effective Date AD. For airplanes that have been modified, source of service information for procedures (f) This amendment becomes effective on altered, or repaired so that the performance to modify the forward flight attendant’s seat, July 23, 2003. of the requirements of this AD is affected, the and to perform follow-on actions (including Issued in Renton, Washington, on June 10, owner/operator must request approval for an replacing the seat identification placard with 2003. alternative method of compliance in a new placard, and installing a new accordance with paragraph (c) of this AD. modification placard). Ali Bahrami, The request should include an assessment of Acting Manager, Transport Airplane the effect of the modification, alteration, or Alternative Methods of Compliance Directorate, Aircraft Certification Service. repair on the unsafe condition addressed by (c) An alternative method of compliance or [FR Doc. 03–15220 Filed 6–17–03; 8:45 am] this AD; and, if the unsafe condition has not adjustment of the compliance time that BILLING CODE 4910–13–P been eliminated, the request should include provides an acceptable level of safety may be specific proposed actions to address it. used if approved by the Manager, Compliance: Required as indicated, unless International Branch, ANM–116, Transport DEPARTMENT OF TRANSPORTATION accomplished previously. Airplane Directorate, FAA. Operators shall To prevent release of the forward flight submit their requests through an appropriate Federal Aviation Administration attendant’s shoulder restraint harness, which FAA Principal Maintenance Inspector, who may add comments and then send it to the could result in injury to the flight attendant 14 CFR Part 39 in case of turbulence; accomplish the Manager, International Branch, ANM–116. following: Note 3: Information concerning the [Docket No. 2001–NM–271–AD; Amendment existence of approved alternative methods of 39–13194; AD 2003–12–09] Modification compliance with this AD, if any, may be (a) Within 18 months after the effective obtained from the International Branch, RIN 2120–AA64 date of this AD: Modify the forward flight ANM–116. attendant’s seat located in the front of the Airworthiness Directives; BAE cabin (including replacing the inertia-reel Special Flight Permits Systems (Operations) Limited Model harness with a new fixed harness, and (d) Special flight permits may be issued in BAe 146 Series Airplanes replace the backrest cover and backrest accordance with sections 21.197 and 21.199 cushion with new components), per ATR of the Federal Aviation Regulations (14 CFR AGENCY: Federal Aviation Service Bulletin ATR42–25–0141, dated 21.197 and 21.199) to operate the airplane to Administration, DOT. October 15, 2002 (for Model ATR42–200, a location where the requirements of this AD ACTION: Final rule. –300, –320, and –500 series airplanes); or can be accomplished. Service Bulletin ATR72–25–1082, dated SUMMARY: Incorporation by Reference This amendment adopts a October 15, 2002 (for Model ATR72–102, new airworthiness directive (AD), –202, –212, and 212A series airplanes); as (e) The actions shall be done in accordance applicable to certain BAE Systems applicable. with Avions de Transport Regional Service Bulletin ATR42–25–0141, dated October 15, (Operations) Limited Model BAe 146 Follow-on Actions 2002; or Avions de Transport Regional series airplanes, that requires (b) Before further flight following Service Bulletin ATR72–25–1082, dated modification of the flight annunciator accomplishment of the modification required October 15, 2002; as applicable. This box. This action is necessary to prevent by paragraph (a) of this AD: Accomplish incorporation by reference was approved by traffic collision avoidance system paragraphs (b)(1) and (b)(2) of this AD per the Director of the Federal Register in (TCAS) aural messages and resolution ATR Service Bulletin ATR42–25–0141, dated accordance with 5 U.S.C. 552(a) and 1 CFR advisories of the TCAS from being October 15, 2002; or ATR Service Bulletin part 51. Copies may be obtained from inhibited following a ground proximity ATR72–25–1082, dated October 15, 2002; as Aerospatiale, 316 Route de Bayonne, 31060 warning system alert or test message, applicable. Toulouse, Cedex 03, France. Copies may be (1) Replace the seat identification placard inspected at the FAA, Transport Airplane which could prevent the TCAS from with a new placard having a new part Directorate, 1601 Lind Avenue, SW., Renton, providing attention-getting alerts, and number (P/N). Washington; or at the Office of the Federal could result in the consequent (2) Install a new modification placard to Register, 800 North Capitol Street, NW., suite possibility of a mid-air collision or near indicate accomplishment of the SICMA 700, Washington, DC. mid-air collision. This action is

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intended to address the identified AD, that it will take approximately 2 PART 39—AIRWORTHINESS unsafe condition. work hours per airplane to accomplish DIRECTIVES DATES: Effective July 23, 2003. the modification, and that the average The incorporation by reference of labor rate is $60 per work hour. ■ 1. The authority citation for part 39 certain publications listed in the Required parts will cost approximately continues to read as follows: regulations is approved by the Director $250 per airplane. Based on these Authority: 49 U.S.C. 106(g), 40113, 44701. of the Federal Register as of July 23, figures, the cost impact of the AD on 2003. U.S. operators is estimated to be $7,400, § 39.13 [Amended] or $370 per airplane. ADDRESSES: The service information ■ 2. Section 39.13 is amended by adding referenced in this AD may be obtained The cost impact figure discussed the following new airworthiness from British Aerospace Regional above is based on assumptions that no directive: Aircraft American Support, 13850 operator has yet accomplished any of 2003–12–09 BAE Systems (Operations) Mclearen Road, Herndon, Virginia the requirements of this AD action, and Limited (Formerly British Aerospace 20171. This information may be that no operator would accomplish Regional Aircraft): Amendment 39– examined at the Federal Aviation those actions in the future if this AD 13194. Docket 2001–NM–271–AD. Administration (FAA), Transport were not adopted. The cost impact Applicability: Model BAe 146 series Airplane Directorate, Rules Docket, figures discussed in AD rulemaking airplanes on which Modifications 1601 Lind Avenue, SW., Renton, actions represent only the time HCM50261X; HCM01077L or HCM50273B; Washington; or at the Office of the necessary to perform the specific actions and HCM50040E or HCM50040N; have been Federal Register, 800 North Capitol actually required by the AD. These installed; certificated in any category. Street, NW., suite 700, Washington, DC. figures typically do not include Note 1: This AD applies to each airplane FOR FURTHER INFORMATION CONTACT: incidental costs, such as the time identified in the preceding applicability Todd Thompson, Aerospace Engineer, required to gain access and close up, provision, regardless of whether it has been International Branch, ANM–116, planning time, or time necessitated by otherwise modified, altered, or repaired in the area subject to the requirements of this Transport Airplane Directorate, 1601 other administrative actions. AD. For airplanes that have been modified, Lind Avenue SW., Renton, Washington Regulatory Impact altered, or repaired so that the performance 98055–4056; telephone (425) 227–1175; of the requirements of this AD is affected, the fax (425) 227–1149. The regulations adopted herein will owner/operator must request approval for an SUPPLEMENTARY INFORMATION: A not have a substantial direct effect on alternative method of compliance in proposal to amend part 39 of the Federal the States, on the relationship between accordance with paragraph (b) of this AD. Aviation Regulations (14 CFR part 39) to The request should include an assessment of the national Government and the States, the effect of the modification, alteration, or include an airworthiness directive (AD) or on the distribution of power and repair on the unsafe condition addressed by that is applicable to certain BAE responsibilities among the various this AD; and, if the unsafe condition has not Systems (Operations) Limited Model levels of government. Therefore, it is been eliminated, the request should include BAe 146 series airplanes was published determined that this final rule does not specific proposed actions to address it. in the Federal Register on March 12, have federalism implications under Compliance: Required as indicated, unless 2003 (68 FR 11760). That action Executive Order 13132. accomplished previously. proposed to require modification of the To prevent aural messages and resolution flight annunciator box. For the reasons discussed above, I advisories of the traffic collision avoidance Interested persons have been afforded certify that this action (1) is not a system (TCAS) from being inhibited an opportunity to participate in the ‘‘significant regulatory action’’ under following a ground proximity warning making of this amendment. No Executive Order 12866; (2) is not a system alert or test message, which could comments were submitted in response ‘‘significant rule’’ under DOT prevent the TCAS from providing attention- Regulatory Policies and Procedures (44 getting alerts, and could result in the to the proposal or the FAA’s consequent possibility of a mid-air collision determination of the cost to the public. FR 11034, February 26, 1979); and (3) will not have a significant economic or near mid-air collision, accomplish the following: Conclusion impact, positive or negative, on a The FAA has determined that air substantial number of small entities Modification safety and the public interest require the under the criteria of the Regulatory (a) Within 1 year after the effective date of adoption of the rule as proposed. Flexibility Act. A final evaluation has this AD: Modify the flight annunciator box been prepared for this action and it is (including installing 2 diode modules with Changes to 14 CFR Part 39/Effect on the contained in the Rules Docket. A copy associated wiring, and re-routing existing AD of it may be obtained from the Rules wiring), per the Accomplishment On July 10, 2002, the FAA issued a Instructions of BAE Systems (Operations) Docket at the location provided under Limited Modification Service Bulletin SB.34– new version of 14 CFR part 39 (67 FR the caption ADDRESSES. 339–50261Y, dated April 11, 2001. Although 47997, July 22, 2002), which governs the List of Subjects in 14 CFR Part 39 paragraph 2.F.(2) of the Accomplishment FAA’s airworthiness directives system. Instructions references a reporting The regulation now includes material Air transportation, Aircraft, Aviation requirement, such reporting is not required that relates to altered products, special safety, Incorporation by reference, by this AD. flight permits, and alternative methods Safety. Alternative Methods of Compliance of compliance. However, for clarity and consistency, this final rule retains the Adoption of the Amendment (b) An alternative method of compliance or adjustment of the compliance time that language of the NPRM regarding that ■ provides an acceptable level of safety may be material. Accordingly, pursuant to the authority used if approved by the Manager, delegated to me by the Administrator, Cost Impact International Branch, ANM–116, Transport the Federal Aviation Administration Airplane Directorate, FAA. Operators shall The FAA estimates that 20 airplanes amends part 39 of the Federal Aviation submit their requests through an appropriate of U.S. registry will be affected by this Regulations (14 CFR part 39) as follows: FAA Principal Avionics Inspector, who may

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add comments and then send it to the maneuvering actuator piston rod of the Request to Credit Work Done Per Manager, International Branch, ANM–116. main landing gear (MLG) to ensure Earlier Service Bulletin Versions Note 2: Information concerning the adequate wall thickness of the piston existence of approved alternative methods of Several commenters request that the rods, and replacement of any discrepant supplemental NPRM be revised to allow compliance with this AD, if any, may be piston rod with a new piston rod. This obtained from the International Branch, credit for work accomplished in ANM–116. amendment is prompted by issuance of accordance with the original version of mandatory continuing airworthiness EMBRAER Service Bulletin 145–32– Special Flight Permits information by a foreign civil 0031, dated July 3, 1998; and Change 01, (c) Special flight permits may be issued in airworthiness authority. The actions dated December 8, 1998. The accordance with sections 21.197 and 21.199 specified by this AD are intended to commenters note that, if the inspection of the Federal Aviation Regulations (14 CFR prevent failure of the maneuvering and related actions have been 21.197 and 21.199) to operate the airplane to actuator piston rod of the MLG, which a location where the requirements of this AD accomplished in accordance with either can be accomplished. would impede retraction of the MLG, of those service bulletin versions, no and consequent reduced controllability additional work would be necessary to Incorporation by Reference of the airplane. accomplish the actions specified in (d) The actions must be done in accordance Change 02 of the service bulletin. The DATES: Effective July 23, 2003. with BAE Systems (Operations) Limited commenters suggest that failure to Modification Service Bulletin SB.34–339– The incorporation by reference of include this credit provision in the AD 50261Y, dated April 11, 2001. This certain publications listed in the incorporation by reference was approved by could unnecessarily require operators to the Director of the Federal Register in regulations is approved by the Director request an alternative method of accordance with 5 U.S.C. 552(a) and 1 CFR of the Federal Register as of July 23, compliance to demonstrate compliance part 51. Copies may be obtained from British 2003. with the requirements of the AD. Aerospace Regional Aircraft American The FAA agrees. The procedures Support, 13850 Mclearen Road, Herndon, ADDRESSES: The service information described in the original issue and Virginia 20171. Copies may be inspected at referenced in this AD may be obtained Change 01 of EMBRAER Service the FAA, Transport Airplane Directorate, from Empresa Brasileira de Aeronautica Bulletin 145–32–0031 are essentially the 1601 Lind Avenue, SW., Renton, S.A. (EMBRAER), P.O. Box 343—CEP same as those described in Change 02. Washington; or at the Office of the Federal 12.225, Sao Jose dos Campos—SP, Register, 800 North Capitol Street, NW., suite Therefore, the original issue and Change 700, Washington, DC. Brazil. This information may be 01 of the service bulletin are also examined at the Federal Aviation Note 3: The subject of this AD is addressed acceptable for compliance with this AD. in British airworthiness directive 003–04– Administration (FAA), Transport Paragraph (a) of this final rule has been 2001. Airplane Directorate, Rules Docket, revised accordingly. 1601 Lind Avenue, SW., Renton, Effective Date Washington; or at the Office of the Conclusion (e) This amendment becomes effective on Federal Register, 800 North Capitol After careful review of the available July 23, 2003. Street, NW., suite 700, Washington, DC. data, including the comment noted above, the FAA has determined that air Issued in Renton, Washington, on July 10, FOR FURTHER INFORMATION CONTACT: Dan 2003. safety and the public interest require the Rodina, Aerospace Engineer, Ali Bahrami, adoption of the rule with the change International Branch, ANM–116, FAA, previously described. The FAA has Acting Manager, Transport Airplane Transport Airplane Directorate, 1601 Directorate, Aircraft Certification Service. determined that this change will neither Lind Avenue, SW., Renton, Washington increase the economic burden on any [FR Doc. 03–15221 Filed 6–17–03; 8:45 am] 98055–4056; telephone (425) 227–2125; BILLING CODE 4910–13–P operator nor increase the scope of the fax (425) 227–1149. AD. SUPPLEMENTARY INFORMATION: A Changes to 14 CFR Part 39/Effect on the DEPARTMENT OF TRANSPORTATION proposal to amend part 39 of the Federal AD Aviation Regulations (14 CFR part 39) to Federal Aviation Administration include an airworthiness directive (AD) On July 10, 2002, the FAA issued a that is applicable to certain EMBRAER new version of 14 CFR part 39 (67 FR 14 CFR Part 39 Model EMB–145 series airplanes was 47997, July 22, 2002), which governs the FAA’s airworthiness directives system. [Docket No. 99–NM–98–AD; Amendment published as a supplemental notice of 39–13196; AD 2003–12–11] proposed rulemaking (NPRM) in the The regulation now includes material that relates to altered products, special RIN 2120–AA64 Federal Register on June 5, 2000 (65 FR 35590). That action proposed to require flight permits, and alternative methods a one-time ultrasonic inspection of the of compliance. However, for clarity and Airworthiness Directives; Empresa consistency in this final rule, we have maneuvering actuator piston rod of the Brasileira de Aeronautica S.A. retained the language of the NPRM main landing gear (MLG) to ensure (EMBRAER) Model EMB–145 Series regarding that material. Airplanes adequate wall thickness of the piston rods, and replacement of any discrepant Cost Impact AGENCY: Federal Aviation piston rod with a new piston rod. Administration, DOT. The FAA estimates that 33 airplanes ACTION: Final rule. Comments of U.S. registry will be affected by this proposed AD, that it will take SUMMARY: This amendment adopts a Interested persons have been afforded approximately 1 work hour per airplane new airworthiness directive (AD), an opportunity to participate in the to accomplish the required actions, and applicable to certain EMBRAER Model making of this amendment. Due that the average labor rate is $60 per EMB–145 series airplanes, that requires consideration has been given to the work hour. Based on these figures, the a one-time ultrasonic inspection of the comments received. cost impact of this AD on U.S. operators

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is estimated to be $1,980, or $60 per § 39.13 [Amended] provides an acceptable level of safety may be airplane. ■ 2. Section 39.13 is amended by adding used if approved by the Manager, the following new airworthiness International Branch, ANM–116, Transport The cost impact figure discussed Airplane Directorate, FAA. Operators shall above is based on assumptions that no directive: submit their requests through an appropriate operator has yet accomplished any of 2003–12–11 Empresa Brasileira de FAA Principal Maintenance Inspector, who the requirements of this AD action, and Aeronautica S.A. (Embraer): may add comments and then send it to the that no operator would accomplish Amendment 39–13196. Docket 99–NM– Manager, International Branch, ANM–116. those actions in the future if this AD 98–AD. Note 2: Information concerning the were not adopted. The cost impact Applicability: Model EMB–145 series existence of approved alternative methods of figures discussed in AD rulemaking airplanes, equipped with main landing gear compliance with this AD, if any, may be maneuvering actuators, part and serial obtained from the International Branch, actions represent only the time numbers as listed in EMBRAER Service ANM–116. necessary to perform the specific actions Bulletin 145–32–0031, Change No. 02, dated actually required by the AD. These February 12, 1999; certificated in any Special Flight Permits figures typically do not include category. (c) Special flight permits may be issued in incidental costs, such as the time Note 1: This AD applies to each airplane accordance with sections 21.197 and 21.199 required to gain access and close up, identified in thepreceding applicability of the Federal Aviation Regulations (14 CFR planning time, or time necessitated by provision, regardless of whether it has been 21.197 and 21.199) to operate the airplane to other administrative actions. modified, altered, or repaired in the area a location where the requirements of this AD subject to the requirements of this AD. For can be accomplished. airplanes that have been modified, altered, or Regulatory Impact Incorporation by Reference repaired so that the performance of the The regulations adopted herein will requirements of this AD is affected, the (d) Unless otherwise specified in this AD, not have a substantial direct effect on owner/operator must request approval for an the actions must be done in accordance with alternative method of compliance in EMBRAER Service Bulletin 145–32–0031, the States, on the relationship between Change No. 02, dated February 12, 1999. This the national Government and the States, accordance with paragraph (b) of this AD. The request should include an assessment of incorporation by reference was approved by or on the distribution of power and the effect of the modification, alteration, or the Director of the Federal Register in responsibilities among the various repair on the unsafe condition addressed by accordance with 5 U.S.C. 552(a) and 1 CFR levels of government. Therefore, it is this AD; and, if the unsafe condition has not part 51. Copies may be obtained from determined that this final rule does not been eliminated, the request should include Empresa Brasileira de Aeronautica S.A. have federalism implications under specific proposed actions to address it. (EMBRAER), P.O. Box 343—CEP 12.225, Sao Executive Order 13132. Compliance: Required as indicated, unless Jose dos Campos—SP, Brazil. Copies may be accomplished previously. inspected at the FAA, Transport Airplane For the reasons discussed above, I To prevent failure of the maneuvering Directorate, 1601 Lind Avenue, SW., Renton, certify that this action (1) is not a actuator piston rod of the main landing gear Washington; or at the Office of the Federal ‘‘significant regulatory action’’ under (MLG), which would impede retraction of the Register, 800 North Capitol Street, NW., suite Executive Order 12866; (2) is not a MLG, and consequent reduced controllability 700, Washington, DC. ‘‘significant rule’’ under DOT of the airplane, accomplish the following: Note 3: The subject of this AD is addressed Regulatory Policies and Procedures (44 in Brazilian airworthiness directive 98–09–01 Ultrasonic Inspection and Replacement, If R1, dated March 15, 1999. FR 11034, February 26, 1979); and (3) Necessary will not have a significant economic (a) Within the next 100 landings after the Effective Date impact, positive or negative, on a effective date of this AD, perform an (e) This amendment becomes effective on substantial number of small entities ultrasonic inspection of the maneuvering July 23, 2003. under the criteria of the Regulatory actuator piston rods of the MLG to ensure Issued in Renton, Washington, on June 10, adequate wall thickness of the piston rods, in Flexibility Act. A final evaluation has 2003. been prepared for this action and it is accordance with EMBRAER Service Bulletin Ali Bahrami, contained in the Rules Docket. A copy 145–32–0031, Change No. 02, dated February of it may be obtained from the Rules 12, 1999. An inspection is also acceptable for Acting Manager, Transport Airplane Directorate, Aircraft Certification Service. Docket at the location provided under compliance with the requirements of this AD if done in accordance with EMBRAER [FR Doc. 03–15222 Filed 6–17–03; 8:45 am] the caption ADDRESSES. Service Bulletin 145–32–0031, dated July 3, BILLING CODE 4910–13–P List of Subjects in 14 CFR Part 39 1998; or Change 01, dated December 8, 1999. (1) If the thickness of any measurement Air transportation, Aircraft, Aviation point in any piston rod is greater than 2.0 DEPARTMENT OF TRANSPORTATION safety, Incorporation by reference, mm (.079 inch), no further action is required by this AD. Federal Aviation Administration Safety. (2) If the thickness of any measurement Adoption of the Amendment point in any piston rod is from 1.5 mm (.059 inch) to 2.0 mm (.079 inch): Within 500 14 CFR Part 39 ■ Accordingly, pursuant to the authority landings after the effective date of this AD, [Docket No. 2002–NE–09–AD; Amendment replace the piston rod with a new rod having 39–13193; AD 2003–12–08] delegated to me by the Administrator, the correct part number as specified in the the Federal Aviation Administration service bulletin. RIN 2120–AA64 amends part 39 of the Federal Aviation (3) If the thickness of any measurement Regulations (14 CFR part 39) as follows: point in any piston rod is less than 1.5 mm Airworthiness Directives; General (.059 inch): Within 50 landings after the Electric Company CF6–80A1/A3 and PART 39—AIRWORTHINESS effective date of this AD, replace the piston CF6–80C2A PMC Series Turbofan DIRECTIVES rod with a new rod having the correct part Engines number as specified in the service bulletin. ■ AGENCY: Federal Aviation 1. The authority citation for part 39 Alternative Methods of Compliance continues to read as follows: Administration, DOT. (b) An alternative method of compliance or ACTION: Final rule. Authority: 49 U.S.C. 106(g), 40113, 44701. adjustment of the compliance time that

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SUMMARY: This amendment adopts a Thereafter, that action proposed to AD has been revised to add Revision 1 new airworthiness directive (AD), that is require one of these actions on a to each of the ASBs. applicable to General Electric Company repetitive basis in accordance with Alternative for Replacement of (GE) CF6–80A1/A3 and CF6–80C2A Middle River Aircraft Systems Alert Serviceable DPV PMC series turbofan engines. This Service Bulletins (ASBs) CF6–80A1/A3 amendment requires performing either a SB 78A4030, dated April 4, 2002 or One commenter requests that directional pilot valve (DPV) pressure CF6–80C2A PMC SB 78A1118, dated deactivation of the fan reverser be switch moisture purge procedure and an April 4, 2002. allowed as an alternative to replacement operational check of the fan reverser or with a serviceable DPV. The commenter Comments replacing the DPV assembly with a sites a previous AD (99–18–19) that serviceable assembly and performing an Interested persons have been afforded allowed deactivation instead of a DPV operational check of the fan reverser. an opportunity to participate in the leak check inspection. Thereafter, this AD requires one of these making of this amendment. Due The FAA agrees and the final rule is actions on a repetitive basis. This consideration has been given to the revised to allow deactivation. amendment is prompted by a review of comments received. Limitations for operation with one or fan reverser safety analyses resulting more reversers deactivated have also from the discovery of an undetectable Request to Revise Applicability Statement been added and are consistent with the failure mode of the DPV pressure switch previous AD. on certain GE CF6–80C2A and CF6– One commenter requests that the 80A1/A3 engine models. The actions applicability statement be revised to Request to Rewrite Description of the specified by this AD are intended to reference the left-hand fan reverser Failure Sequence prevent inadvertent fan reverser halves associated with the engines One commenter requests that the deployment, which, if it occurred in- instead of the engine models description of the failure sequence in flight, could result in loss of control of themselves. The commenter believes the discussion section of the NPRM the airplane. that the DPV assembly is not a part of preamble be reworded to clarify that an DATES: Effective July 23, 2003. The the engine, but is instead a part of the additional failure is required in order incorporation by reference of certain left-hand fan reverser half. The for the undetectable DPV pressure publications listed in the regulations is commenter notes the fact that the switch freezing failure to result in an approved by the Director of the Federal reverser halves and engines can be inadvertent deployment (IAD). The Register as of July 23, 2003. removed or installed separately. commenter believes that the current ADDRESSES: The service information The FAA does not agree. The FAA statement is misleading. The commenter referenced in this AD may be obtained acknowledges that in service the believes that in addition to the from Middle River Aircraft Systems, engines and fan reversers can be pressurization failure, a directional Mail Point 46, 103 Chesapeake Park separated, with the possibility of failure is required before an IAD can Plaza, Baltimore, MD, 21220–4295, reversers remaining installed on-wing, occur. telephone: (410) 682–0094; fax: (410) while different engines are installed. The FAA does not agree. While the 682–0100. This information may be However, the fan reverser assembly and, FAA agrees that the wording could have examined, by appointment, at the therefore, the DPV are part of the engine been clearer, the requested change does Federal Aviation Administration (FAA), (14 CFR part 33) type design. The not affect the conclusion that an unsafe New England Region, Office of the applicability to the engine model is, condition has been identified. In Regional Counsel, 12 New England therefore, appropriate. No changes will addition, the Discussion section details Executive Park, Burlington, MA; or at be made to the AD as a result of this are not repeated in the final rule after an the Office of the Federal Register, 800 comment. NPRM, and therefore, the AD remains North Capitol Street, NW., suite 700, unchanged as a result of this comment. Washington, DC. Request to Add Isopropyl Alcohol as an Alternate to Acetone After careful review of the available FOR FURTHER INFORMATION CONTACT: data, including the comments noted Karen Curtis, Aerospace Engineer, One commenter requests that above, the FAA has determined that air Engine Certification Office, FAA, Engine isopropyl alcohol be allowed as an safety and the public interest require the and Propeller Directorate, 12 New acceptable alternate to the acetone adoption of the rule with the changes England Executive Park, Burlington, MA solvent listed in the consumables of the described previously. The FAA has 01803–5299; telephone (781) 238–7192; ASBs as the fluid used for purging determined that these changes will fax (781) 238–7199. moisture from the DPV pressure switch neither increase the economic burden SUPPLEMENTARY INFORMATION: A assemblies. The commenter notes that on any operator nor increase the scope proposal to amend part 39 of the Federal some airports may restrict the use of of the AD. Aviation Regulations (14 CFR part 39) to acetone. The commenter also notes that Regulatory Analysis include an AD that is applicable to the DPV assembly manufacturer has General Electric Company (GE) CF6– agreed that alcohol is an acceptable This final rule does not have 80A1/A3 and CF6–80C2A PMC series alternate for acetone for the purposes of federalism implications, as defined in turbofan engines was published in the accomplishing the moisture purge Executive Order 13132, because it Federal Register on June 21, 2002 (67 service bulletins. would not have a substantial direct FR 42202). That action proposed to The FAA agrees that isopropyl effect on the States, on the relationship require performing either a directional alcohol is an acceptable alternate for between the national government and pilot valve (DPV) pressure switch acetone for this application. The FAA, the States, or on the distribution of moisture purge procedure and an GE, and the component manufacturer, power and responsibilities among the operational check of the fan reverser, or previously identified this issue and the various levels of government. replacing the DPV assembly with a ASBs were revised on August 23, 2002, Accordingly, the FAA has not consulted serviceable assembly and performing an to allow the use of isopropyl alcohol. with state authorities prior to operational check of the fan reverser. The compliance section of this final rule publication of this final rule.

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For the reasons discussed above, I deployment, which, if it occurred in-flight, Instructions of Middle River Aircraft Systems certify that this action (1) is not a could result in loss of control of the airplane, ASBs CF6–80C2A PMC SB 78A1118, dated ‘‘significant regulatory action’’ under do the following: April 4, 2002, or CF6–80C2A PMC SB Executive Order 12866; (2) is not a 78A1118, Revision 1, dated August 23, 2002, GE CF6–80A1/A3 Series Engines or ‘‘significant rule’’ under the DOT (a) For GE CF6–80A1/A3 series engines, (2) Replace the DPV assembly with a Regulatory Policies and Procedures (44 perform one of the following no later than serviceable assembly, or FR 11034, February 26, 1979); and (3) 1,400 flight hours time-since-new (TSN) or (3) Deactivate the thrust reverser. The DPV will not have a significant economic 600 flight hours time-in-service (TIS) after must be replaced with a serviceable assembly impact, positive or negative, on a the effective date of this AD, whichever within 10 days after deactivation. substantial number of small entities occurs later: Information on deactivating the thrust under the criteria of the Regulatory (1) Perform the directional pilot valve reverser can be found in the applicable Flexibility Act. A final evaluation has (DPV) pressure switch moisture purge, in AMM. accordance with Paragraph 3.C. of the been prepared for this action and it is (f) After each purge or replacement done in Accomplishment Instructions of Middle accordance with paragraphs (e)(1), (e)(2), or contained in the Rules Docket. A copy River Aircraft Systems Alert Service (e)(3) of this AD, perform an operational of it may be obtained by contacting the Bulletins (ASBs) CF6–80A1/A3 SB 78A4030, check of the fan reverser, in accordance with Rules Docket at the location provided dated April 4, 2002, or CF6–80A1/A3 SB Paragraph 3.E. of the Accomplishment under the caption ADDRESSES. 78A4030, Revision 1, dated August 23, 2002, Instructions ASBs CF6–80C2A PMC SB or 78A1118, dated April 4, 2002, or CF6–80C2A List of Subjects in 14 CFR Part 39 (2) Replace the DPV assembly with a PMC SB 78A1118, Revision 1, dated August Air transportation, Aircraft, Aviation serviceable assembly, or 23, 2002. safety, Incorporation by reference, (3) Deactivate the thrust reverser. The DPV (g) Thereafter, for GE CF6–80C2A1/A2/A3/ Safety. must be replaced with a serviceable assembly A5/A8 series engines, perform one of the within 10 days after deactivation. following at intervals not to exceed 1,400 Adoption of the Amendment Information on deactivating the thrust hours TIS since the last pressure switch reverser can be found in the applicable ■ purge or replacement of the DPV assembly: Accordingly, pursuant to the authority Aircraft Maintenance Manual (AMM). (1) Perform the DPV pressure switch delegated to me by the Administrator, (b) After each purge or replacement done moisture purge, in accordance with the Federal Aviation Administration in accordance with paragraph (a)(1), (a)(2), or Paragraph 3.C. of the Accomplishment amends part 39 of the Federal Aviation (a)(3) of this AD, perform an operational Instructions of Middle River Aircraft Systems Regulations (14 CFR part 39) as follows: check of the fan reverser in accordance with ASBs CF6–80C2A PMC SB 78A1118, dated Paragraph 3.E. of the Accomplishment April 4, 2002, or CF6–80C2A PMC SB PART 39—AIRWORTHINESS Instructions of ASBs CF6–80A1/A3 SB 78A1118, Revision 1, dated August 23, 2002, DIRECTIVES 78A4030, dated April 4, 2002, or CF6–80A1/ or A3 SB 78A4030, Revision 1, dated August 23, (2) Replace the DPV assembly with a ■ 1. The authority citation for part 39 2002. serviceable assembly, or continues to read as follows: (c) Thereafter, for GE CF6–80A1/A3 series (3) Deactivate the thrust reverser. The DPV engines, at intervals not to exceed 1,400 Authority: 49 U.S.C. 106(g), 40113, 44701. must be replaced with a serviceable assembly hours TIS since the last pressure switch within 10 days after deactivation. § 39.13 [Amended] purge or replacement of the DPV assembly, Information on deactivating the thrust perform one of the following: ■ reverser can be found in the applicable 2. Section 39.13 is amended by adding (1) Perform the DPV pressure switch AMM. a new airworthiness directive to read as moisture purge, in accordance with (h) After each purge or replacement done follows: Paragraph 3.C. of the Accomplishment in accordance with paragraphs (g)(1), (g)(2), 2003–12–08 General Electric Company: Instructions of Middle River Aircraft Systems or (g)(3) of this AD, perform an operational Amendment 39–13193. Docket No. ASBs CF6–80A1/A3 SB 78A4030, dated check of the fan reverser, in accordance with 2002–NE–09–AD. April 4, 2002, or CF6–80A1/A3 SB 78A4030, Paragraph 3.E. of the Accomplishment Revision 1, dated August 23, 2002, or Applicability: This airworthiness directive Instructions of ASBs CF6–80C2A PMC SB (2) Replace the DPV assembly with a (AD) is applicable to General Electric 78A1118, dated April 4, 2002, or CF6–80C2A serviceable assembly, or Company (GE) CF6–80A1/A3 and CF6– PMC SB 78A1118, Revision 1, dated August (3) Deactivate the thrust reverser. The DPV 80C2A PMC series turbofan engines. These 23, 2002. must be replaced with a serviceable assembly engines are installed on, but not limited to within 10 days after deactivation. Serviceable DPV Assembly Airbus Industrie A300–600 and A310 series Information on deactivating the thrust (i) For the purpose of this AD, a serviceable airplanes. reverser can be found in the applicable DPV assembly is an assembly that has: Note 1: This AD applies to each engine AMM. (1) Accumulated zero time since new, or identified in the preceding applicability (d) After each purge or replacement done (2) Passed the tests in the Middle River provision, regardless of whether it has been in accordance with paragraph (c)(1), (c)(2), or Aircraft Systems Component Maintenance modified, altered, or repaired in the area (c)(3) of this AD, perform an operational Manual GEK 85007 (78–31–51), Revision No. subject to the requirements of this AD. For check of the fan reverser in accordance with 7 or later, Directional Pilot Solenoid Valve, engines that have been modified, altered, or Paragraph 3.E. of the Accomplishment Page Block 101, Testing and Troubleshooting, repaired so that the performance of the Instructions of ASBs CF6–80A1/A3 SB and that has zero flight hours TIS since requirements of this AD is affected, the 78A4030, dated April 4, 2002, or CF6–80A1/ passing the tests, or owner/operator must request approval for an A3 SB 78A4030, Revision 1, dated August 23, (3) Been successfully purged according to alternative method of compliance in 2002. paragraphs (a)(1), (c) (1), (e)(1) or (g)(1) of this accordance with paragraph (k) of this AD. AD immediately before installation on the The request should include an assessment of GE CF6–80C2A Series Engines fan reverser. the effect of the modification, alteration, or (e) For GE CF6–80C2A1/A2/A3/A5/A8 repair on the unsafe condition addressed by series engines, perform one of the following Deactivation Requirements this AD; and, if the unsafe condition has not no later than 1,400 flight hours TSN or 600 (j) If one or both thrust reversers are been eliminated, the request should include flight hours TIS after the effective date of this deactivated, then prior to further flight, specific proposed actions to address it. AD, whichever occurs later: revise the Limitations Section of the FAA- Compliance: Compliance with this AD is (1) Perform the DPV pressure switch approved AFM to include the following: required as indicated, unless already done. moisture purge, in accordance with ‘‘The takeoff performance on wet and To prevent inadvertent fan reverser Paragraph 3.C. of the Accomplishment contaminated runways with a thrust

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reverser(s) deactivated shall be determined in Operating Manual Section 2.18.50, unless all FAA Principal Maintenance Inspector, who accordance with Airbus Flight Operations components of the Main Wheel Brakes, Green may add comments and then send it to the Telex (FOT) 999.0066/99, dated June 9, 1999, and Yellow Brake Systems, Antiskid System, Manager, ECO. as follows: Ground Spoiler System, and all Spoiler and Note 3: Information concerning the For takeoff on wet runways, use Speed Brake Surfaces, operate normally. existence of approved alternative methods of performance data in accordance with Note 2: The ‘‘FCOM’’ referenced in Airbus compliance with this airworthiness directive, paragraph 4.1.1 of the FOT. FOT 999.0066/99, dated June 9, 1999, is if any, may be obtained from the ECO. For takeoff on contaminated runways, use Airbus Industrie Flight Crew Operating performance data in accordance with Special Flight Permits paragraph 4.1.2 of the FOT.’’ Manual (FCOM), Revision 27 for Airbus (1) Notwithstanding the provisions of the Model A310 series airplanes and Revision 22 (l) Special flight permits may be issued in FAA approved A300–600 and A310 Master for A300–600 series airplanes. [The revision accordance with §§ 21.197 and 21.199 of the Minimum Equipment List (MMEL), dispatch number is indicated on the List of Effective Federal Aviation Regulations (14 CFR 21.197 with both thrust reversers deactivated, for the Pages (LEP) of the FCOM.] and 21.199) to operate the airplane to a purposes of complying with this AD, is location where the requirements of this AD Alternative Methods of Compliance approved. can be done. (2) Notwithstanding the provisions of the (k) An alternative method of compliance or FAA Approved A300–600 and A310 MMEL, adjustment of the compliance time that Documents That Have Been Incorporated By airplanes which have deactivated one or both provides an acceptable level of safety may be Reference thrust reversers in compliance with this AD, used if approved by the Manager, Engine (m) The actions must be done in may not conduct operation on contaminated Certification Office (ECO). Operators must accordance with the following Middle River runways, as defined in Airbus Flight Crew submit their request through an appropriate Aircraft Systems Alert Service Bulletins:

Document no. Pages Revision Date

CF6–80C2A, PMC SB 78A1118 ...... All ...... Original .... April 4, 2002 Total Pages: 18. CF6–80C2A, PMC SB 78A1118 ...... 1 ...... 1 ...... August 23, 2002 2–4 ...... Original .... April 4, 2002 5 ...... 1 ...... August 23, 2002 6–8 ...... Original .... April 4, 2002 9–10 ...... 1 ...... August 23, 2002 11–18 ...... Original .... April 4, 2002 Total Pages: 18. CF6–80A1/A3, SB 78A4030 ...... All ...... Original .... April 4, 2002 Total Pages: 18. CF6–80A1/A3, SB 78A4030 ...... 1 ...... 1 ...... August 23, 2002 2–4 ...... Original .... April 4, 2002 5 ...... 1 ...... August 23, 2002 6–8 ...... Original .... April 4, 2002 9–10 ...... 1 ...... August 23, 2002 11–18 ...... Original .... April 4, 2002 Total Pages: 18.

This incorporation by reference was FEDERAL TRADE COMMISSION the conditional exemption described approved by the Director of the Federal herein is June 11, 2003. Register in accordance with 5 U.S.C. 552(a) 16 CFR Part 305 FOR FURTHER INFORMATION CONTACT: and 1 CFR part 51. Copies may be obtained Hampton Newsome, Attorney, Division Rule Concerning Disclosures from Middle River Aircraft Systems, Mail of Enforcement, Federal Trade Regarding Energy Consumption and Point 46, 103 Chesapeake Park Plaza, Commission, Washington, DC 20580, Water Use of Certain Home Appliances Baltimore, MD, 21220–4295, telephone: (410) (202) 326–2889. 682–0094; fax: (410) 682–0100. Copies may and Other Products Required Under SUPPLEMENTARY INFORMATION: be inspected at the FAA, New England the Energy Policy and Conservation Region, Office of the Regional Counsel, 12 Act (‘‘Appliance Labeling Rule’’) I. Background New England Executive Park, Burlington, MA; or at the Office of the Federal Register, AGENCY: Federal Trade Commission. A. FTC Requirements 800 North Capitol Street, NW., suite 700, ACTION: Final rule and conditional The Commission issued the Washington, DC. exemption. Appliance Labeling Rule in 1979, 44 FR 66466 (Nov. 19, 1979) (‘‘Rule’’), in Effective Date SUMMARY: The Federal Trade response to a directive in the Energy Commission (‘‘Commission’’) Policy and Conservation Act of 1975 (n) This amendment becomes effective on announces amendments to the (‘‘EPCA’’) (42 U.S.C. 6294). EPCA also July 23, 2003. Appliance Labeling Rule and the requires the Department of Energy Issued in Burlington, Massachusetts, on issuance of a conditional exemption in (‘‘DOE’’) to develop test procedures that June 9, 2003. response to a request from the measure how much energy certain Association of Home Appliance Francis A. Favara, appliances use, and to determine the Manufacturers (‘‘AHAM’’) related to representative average cost a consumer Acting Manager, Engine and Propeller certain labeling requirements for clothes Directorate, Aircraft Certification Service. pays for the different types of available washers. energy. [FR Doc. 03–15223 Filed 6–17–03; 8:45 am] DATES: The effective date of the The rule covers, among other things, BILLING CODE 4910–13–P amendments to 16 CFR part 305 is eight categories of major household January 1, 2004. The effective date of appliances: refrigerators and

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refrigerator-freezers, freezers, Appendix J1.2 Application of the new year and issue rule amendments to dishwashers, clothes washers, water test procedure (sometimes referred to as make the requested labeling changes a heaters, room air conditioners, furnaces, the ‘‘J1’’ test or the ‘‘Modified Energy permanent requirement for all and central air conditioners. The rule Factor’’ test) will likely produce energy manufacturers after January 1, 2004. requires manufacturers of all covered consumption figures different from AHAM submitted its request because appliances to disclose specific energy those yielded by the old (‘‘J’’) test it asserts that the transition to clothes consumption or efficiency information procedure (10 CFR part 430, subpart B, washers compliant with the new 2004 (derived from the DOE test procedures) Appendix J).3 Because these test results energy efficiency standard and new test at the point of sale in the form of an are used to determine energy use procedure, with respect to testing and ‘‘EnergyGuide’’ label and in catalogs. information that appears on the FTC labeling, could be unduly burdensome The rule requires manufacturers to EnergyGuide label, consumers may not to manufacturers and confusing to include, on labels, an energy be able effectively to compare the consumers. According to AHAM, there consumption or efficiency figure and a energy performance of clothes washers will be hundreds of new energy efficient ‘‘range of comparability.’’ This range if the labels are based on the two models introduced throughout the shows the highest and lowest energy different test procedures. course of 2003. Under current requirements, manufacturers will have consumption or efficiencies for all II. AHAM’s Request comparable appliance models so to test and rate these new models first consumers can compare the energy To ease the transition to the new under the old (J) procedure for 2003, consumption or efficiency of other energy efficiency standard and new (J1) and then again under the new (J1) models similar to the labeled model. test procedure, AHAM 4 wrote to FTC procedure in order to distribute them in The rule requires manufacturers, after staff on February 7, 2003, requesting 2004. AHAM stated that, since several filing an initial report, to report permission to begin using that test for samples of each basic model need to be annually the estimated annual energy labeling clothes washers during 2003, tested to determine statistically valid consumption or energy efficiency before the test becomes effective. In ratings, such duplicative testing would ratings for the appliances derived from addition, AHAM’s letter requests that result in tremendous laboratory and tests performed pursuant to the DOE test the Commission allow its members to manufacturer staff resources for procedures. 16 CFR 305.8(b). Because provide special wording on the hundreds of new models. Also, AHAM manufacturers regularly add new EnergyGuide labels for these models to states that retail floor models are not models to their lines, improve existing help consumers in distinguishing changed frequently. Thus, without models, and drop others, the database washers tested under the new (J1) action by the FTC, retail display units from which the ranges of comparability procedure from those tested under the for new models introduced this year are calculated is constantly changing. old (J) procedure (see Prototype Label 2 will have energy labels based on the old (J) test well into 2004 and beyond. Under section 305.10 of the rule, to keep at the end of this document). AHAM AHAM is concerned that these display the required information on labels proposed a modified label that would units could be very confusing and consistent with these changes, the display a banner across the top stating: misleading as consumers seek to Commission publishes new ranges (but ‘‘This Model has been Tested to the compare units tested under different not more often than annually) if an 2004 Test Procedure. Compare only procedures in a single showroom analysis of the new information with Models with this Notice.’’ AHAM without any notice that differences indicates that the upper or lower limits requested that the Commission allow its exist. of the ranges have changed by more members to begin using the new (J1) test than 15%. Otherwise, the Commission and modified labels on May 1, 2003, III. Proposed Exemption and Proposed publishes a statement that the prior and that the labeling changes be made Rulemaking 5 ranges remain in effect for the next year. ‘‘permanent.’’ To grant AHAM’s request, the Commission would have to In an April 3, 2003, document (68 FR B. New DOE Test Procedure and Energy grant an exemption from certain 16231), the Commission sought Standards for Clothes Washers EnergyGuide testing and labeling comments on AHAM’s proposal. The requirements for the remainder of this proposal raised two procedural matters: New energy conservation standards (1) A request for an exemption from and a new DOE test procedure for 2 certain testing and labeling clothes washers will become effective The EnergyStar program, run by DOE and the U.S. Environmental Protection Agency, already requirements for clothes washers from on January 1, 2004. The new energy requires use of the new (J1) test to certify clothes May through December 31, 2003 (to conservation standard requires that all washers under that program. permit testing and labeling pursuant to 3 new residential clothes washers According to AHAM, the clothes washer test the new (J1) test); and (2) a proposed manufactured after January 1, 2004, be procedures were revised to better reflect current usage habits by incorporating updated temperature ‘‘permanent’’ rule change, effective 22% more efficient than today’s utilization factors that are more appropriate for January 1, 2004, to conform existing 1 minimally compliant clothes washer. today’s designs. label content and format requirements Accordingly, the 2004 energy standard 4 The manufacturers identified in AHAM’s to label changes permitted by the 2003 request are Alliance Laundry Systems, Electrolux will render a substantial portion of the exemption. existing clothes washer market obsolete. Home Products, Fisher & Paykel Ltd., GE Appliances, Maytag Appliances, Miele Corp., and A. Proposed Conditional Exemption for The new DOE test procedure for Whirlpool Corp. Subsequently, AHAM informed clothes washers, which also will Commission staff that BSH, Gonrenje, and Asko 2003 become effective on January 1, 2004, is also are participating in AHAM’s request. The proposed exemption implicated According to AHAM, these manufacturers produce found at 10 CFR part 430, subpart B, over 95% of the clothes washers sold in the United several provisions of the Appliance States. Labeling rule. The rule requires that, for 1 66 FR 3314, 3315 (Jan. 12, 2001). A second 5 AHAM also requested that the Commission purposes of the EnergyGuide label, amended energy efficiency standard, slated to take change the reporting date for clothes washer data manufacturers use the estimated annual effect on January 1, 2007, requires that all new in the rule from March 1 to October 1 for each year. residential clothes washers manufactured after that The Commission addressed the requested date energy consumption as derived from the date be 35% more efficient than today’s minimally change for data submission in an earlier Federal DOE clothes washer test procedures in compliant clothes washer. Register document (see 68 FR 8448 (Feb. 21, 2003)). 10 CFR part 430 (see 16 CFR 305.5(a)

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and 305.11(a)(5)(i)(E)). Because the new with J1 labeling requirements in 2003 is as requested by AHAM. First, because (J1) test for clothes washers will not critical to the efficiency of testing and the new conservation standard will become effective until January 1, 2004, production as the industry transitions to become effective on the same date as the the current rule does not authorize the new washer standards by the end of new test procedure, a large number of use of that test for energy consumption 2003.’’7 Whirlpool echoed AHAM’s new models will appear on the market information on EnergyGuide labels until comment, adding that, without the over a short period of time in response that date. By granting the requested conditional exemption, it would be not to the more stringent efficiency exemption, the Commission would be able ‘‘to meet existing commitments standards. In addition, the differences allow manufacturers to begin using the to trade partners.’’8 These three between the results of the old and new new test results on EnergyGuide labels commenters also supported the proposal test procedures could be quite before 2004. In addition, the rule does to make the changes to the EnergyGuide substantial in this case, up to 40% as not allow any marks or identification label permanent. The fourth commenter, indicated by the industry comments. other than those specified in the rule to NRCan (the agency responsible for Finally, because the exemption will appear on the label except for some appliance labeling in Canada), raised allow manufacturers to begin using the limited exceptions not applicable here concerns about the impact of the new (J1) test results for labeling early, (see 16 CFR 305.11(a)(5)(i)(K)). proposal on adjoining labels bearing manufacturers will distribute new Accordingly, absent an exemption, the both the U.S. EnergyGuide and the products with labels based on the new rule does not allow the kind of Canadian ‘‘EnerGuide’’ label (as allowed test while they will continue to explanatory information proposed by by the Commission’s rule). An analysis distribute older products with labels AHAM. of specific issues raised by the reflecting the old test. Accordingly, the comments follows: transition between the old and new B. Proposed Rule Change for labels in showrooms will likely be EnergyGuide Labels for 2004 and A. Differences Between the J and J1 longer than is usually the case when Beyond Tests DOE amends a test procedure. In the April 3, 2003, document, the Comments Considering all these factors, the Commission indicated that, by granting The Commission requested comments Commission believes that explanatory the exemption, it is probable that many on whether the differences between the language as suggested by AHAM is new clothes washers distributed for sale results yielded by the new (J1) and old appropriate. in the United States for the remainder (J) tests are significant enough to B. Content, Size, and Placement of the of 2003 would have labels containing warrant special advisory language on Modified Language the proposed advisory language that: the EnergyGuide labels. The ‘‘This Model has been Tested to the Commission also asked whether one test Comments 2004 Test Procedure. Compare only yields significantly higher or lower The Commission solicited comments with Models with this Notice.’’ Once results than the other. The three on the proposed changes to the label, this change is made to EnergyGuide industry comments indicated that the such as the content, size, and placement labels on units distributed in 2003, a differences were significant enough to of the modified language on the return to the conventional label in the warrant the change. Alliance stated that EnergyGuide. The Commission asked future may cause consumer confusion the tests yielded a 25% difference for whether the proposed language on the 9 because the units with the modified one of its models. Whirlpool and EnergyGuide label will help consumers label will stay on showroom floors into AHAM commented that the new (J1) test in their purchasing decisions, or cause 2004 and beyond. Given these results are generally lower than the undue confusion. In addition, considerations, AHAM asked the older (J) test results and the differences 10 commenters were asked whether the Commission to make its proposed label could be as much as 40%. reference to the year ‘‘2004’’ on the label changes permanent. The Commission Discussion will create confusion in subsequent proposed that the advisory language According to the commenters, the years if the proposed change becomes a required by the rule after January 1, permanent fixture on the label and 2004, should be identical to that on the differences in energy use results yielded by the two tests can be significant. whether the explanatory language label during the exemption period. The should be required on both the top and Commission sought public comment on Given this information, we believe the explanatory text on the labels is the bottom of the label. The Commission a proposed rule change that would sought comment on alternatives to the incorporate AHAM’s suggested label appropriate to aid consumers in distinguishing models tested under the proposed advisory language, such as changes and require these changes for using the term ‘‘J1’’ or ‘‘Modified Energy all clothes washers distributed for sale two procedures. The Commission notes that DOE periodically modifies the test Factor’’ in lieu of ‘‘2004’’ in describing in the United States beginning January the test. 1, 2004. procedure for covered products and such changes can yield different test The three industry comments stated IV. Comment Analysis results for the same model. In the past, that the proposed changes are the Commission has not required appropriate and that the changes to the The Commission received four EnergyGuide label will help consumers. comments in response to the April 3, additional information on the 6 EnergyGuide label in response to test Whirlpool stated that there will be less 2003, document. The three industry need for dealers to ‘‘refloor’’ model comments (from Alliance, Whirlpool, procedure changes. In this case, however, there are special units and less confusion for ‘‘energy and AHAM) supported the proposed conscientious consumers when conditional exemption and rule change. circumstances that, in the Commission’s selecting new appliances.’’11 The AHAM stated that, ‘‘early compliance view, warrant the explanatory language industry commenters also preferred the 7 reference to ‘‘the 2004 procedure’’ over 6 The Commission received comments from AHAM (3) p. 1. Alliance Laundry Systems (‘‘Alliance’’) (1), 8 Whirlpool (2) p. 3. other descriptors such as ‘‘J1’’ or Whirlpool Corporation (‘‘Whirlpool’’) (2), AHAM 9 Alliance (1) p. 1 (attachment). (3), and Natural Resources Canada (‘‘NRCan’’) (4). 10 AHAM (3) p. 2; Whirlpool (2) p. 4. 11 Whirlpool (2) p. 4

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‘‘Modified Energy Factor’’ because explanatory statements on the labels in Mexico or Canada. Manufacturers using consumers would have ‘‘no clue’’ as to the future, the issuance of new ranges such joint labels generally print them on the meaning of these latter terms.12 could provide the Commission with the hang tags with the U.S. label on one side They did not believe it was necessary to opportunity to consider eliminating the and the Canadian label on the other. place the explanatory language on the advisory language published here. NRCan raised concerns about the impact bottom of the label (in addition to the The Commission has decided to make of the proposal for consumers statements proposed for the top and minor revisions to the proposed examining these adjoining labels. middle of the label). Whirlpool wrote wording of the explanatory language. Beginning in 2004, NRCan will require that such information would be Instead of stating in the banner on top an equivalent of the J1 test for labeling redundant for consumers.13 Finally, of the label that, ‘‘This Model has been purposes. That agency, however, may AHAM and Alliance requested that the Tested to the 2004 Test Procedure. not have time to harmonize fully with size of the new label be 73⁄8 inch (18.73 Compare only with Models with this the FTC’s exemption and rule if the cm.) as currently required by the Rule Notice,’’ the Commission believes that it changes are implemented as proposed and not 8 inches (20.32 cm.) as is preferable to state, ‘‘This model has before then. Therefore, NRCan is proposed by the Commission.14 been tested using the 2004 test concerned that there may be confusion Alliance suggested that the use of a 73⁄8 procedure. Compare only with models if both labels do not report the same inch (18.73 cm.) label can be displaying this statement.’’ Similarly, information on both sides. NRCan accomplished by not incorporating the the Commission has changed the indicated, however, that it has proposed text in the middle of the explanatory text in the middle of the discussed options with the Canadian label.15 label to read: ‘‘Compare the energy use Appliance Manufacturers Association of this clothes washer only with models and is willing to work to identify non- Discussion tested using the 2004 test procedure.’’ regulatory approaches to this issue.16 The Commission agrees with the These modifications replace the phrase Without such a resolution, commenters that the ‘‘2004’’ language is ‘‘Tested to the’’ with ‘‘tested using the’’ manufacturers would continue to use preferable to alternatives such as ‘‘J1’’ (emphasis added). In addition, the the Canadian equivalent of the old (J) and ‘‘Modified Energy Factor.’’ It is phrase ‘‘with this Notice’’ in the top test for new models sold in Canada until possible that, in later years, the banner has been changed to ‘‘displaying the end of this year. reference to ‘‘2004’’ on the label may this statement.’’ The final language also The other commenters believed that raise questions for consumers. eliminates stray capitalization that the proposal would not cause confusion Ultimately, however, we do not believe appeared in the proposed language. The where adjoining labels are used. AHAM that this reference will have a Commission believes these minor stated that the EnergyGuide label is significant impact on consumers’ ability changes will make it easier for discernable from that of Mexico or to compare clothes washer energy use consumers to understand the intended Canada because it is entirely in English, because the relevant energy use and message. has a unique format, and clearly states operating cost information will be Finally, some commenters stated that that the results are based on U.S. clearly marked on the label. the conventional size label (73⁄8 inches; government tests. In addition, AHAM Accordingly, we have retained the 18.73 cm.) should be used for the suggested that the proposed J1 label reference to ‘‘2004’’ in the explanatory exemption and final rule instead of an would make it clear that the label language for the final rule. 8 inch (20.32 cm.) label as proposed. should only be compared with other The Commission recognizes that it Upon further review, the existing label labels bearing the same message.17 may not be desirable to retain this size (73⁄8 inch; 18.73 cm.) will Alliance asserted that, ‘‘[t]he ‘‘2004’’ reference on the clothes washer accommodate the additional banner. We Commission’s first priority is to provide labels indefinitely. Although the see no significant benefit to requiring accurate information to U.S. consumers, explanatory language will aid the proposed 8 inch (20.32 cm.) label not withhold action or information consumers during the upcoming instead of the conventional 73⁄8 inch because of potential impacts to transition period, the language will (18.73 cm.) label. The Commission, consumers in neighboring countries.’’ In eventually become unnecessary because however, does not agree with Alliance its view, any confusion resulting from all models will carry the same label. The that the modified language in the the change would be far less than the Commission may consider eliminating middle of the label should be removed. confusion that would result if the the special advisory language from the This language in the middle of the label Commission does not issue the rule in the future. Each year, the reinforces the message provided by the proposed exemption and amendment.18 Commission analyzes energy use explanatory information in the top Discussion information submitted for all clothes banner. Using existing font and format washers sold in the United States to requirements for the EnergyGuide label, The Commission understands NRCan’s concerns about the use of new determine whether the ranges of the conventional (73⁄8 inch; 18.73 cm.) comparability for the EnergyGuide label can accommodate the explanatory (J1) test data on labels and the advisory labels should change. If the Commission language at the top and in the middle of language related to that test on adjoining determines to amend the ranges in a the label (as shown in Prototype Label U.S.-Canadian labels. We do not, given year, new labels printed as a 2). however, believe that these concerns result will display different ranges and warrant a change to the proposed use updated information to calculate C. Impact on Canadian and Mexican conditional exemption and rule operating costs. Accordingly, if there is Labels amendments. Beginning January 1, perceived need to discontinue the Comments 2004, all models distributed in the U.S. and Canada will display labels based on The Commission asked whether the 12 AHAM (3) p. 2; Alliance (1) p. 2; and Whirlpool the same test. Before that time, it is (2) p. 4. implementation of AHAM’s proposal 13 Whirlpool (2) p. 4. would cause consumer confusion for 16 NRCan (4) pp. 1–2. 14 AHAM (3) p. 2; Alliance (1) p. 2. those units with EnergyGuide labels 17 AHAM (3) p. 2; see also Whirlpool (2) p. 4. 15 Alliance (1) p. 2. adjoining energy labels required by 18 Alliance (1) p. 2.

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unclear whether manufacturers will burden on manufacturers. It estimated June 11, 2003, and December 31, 2003;24 distribute new models in Canada if, in that the proposal would save that and doing so, they will have to conduct the company 35 working days of one (2) For such models, use EnergyGuide same double testing they have sought to laboratory technician dedicated to DOE labels that contain the following avoid through their petition to the energy testing.22 modifications to the format and content Commission. In addition, NRCan, as requirements in 16 CFR 305.11, as suggested in its comment, may identify Discussion illustrated in Prototype Label 2 at the a ‘‘non-regulatory’’ solution that allows end of this document: The manufacturers have described the (a) The use of the statement ‘‘Compare manufacturers to use the J1 test for burdens they are seeking to avoid labels on products sold in Canada and the energy use of this clothes washer through the requested exemption. The only with other models tested using the thus eliminate these concerns Commission believes that issuance of altogether. 2004 test procedure’’ in lieu of the the exemption and final rule will help statement ‘‘Compare the Energy Use of Even assuming some new models are to avoid those burdens while, at the distributed this year bearing the joint this Clothes Washer with Others Before same time, minimizing any consumer You Buy’’; and label, the Commission does not expect confusion associated with the transition that differences between the Canadian (b) The use of the statement ‘‘This from the old Appendix J test procedure model has been tested using the 2004 and U.S. labels will significantly to the new Appendix J1 procedure. impede consumers’ ability to compare test procedure. Compare only with the energy use of competing products. V. Final Conditional Exemption and models displaying this statement.’’ in a Since 1996, the Commission’s rule has Amendments 10/16 inch (1.59 cm.) in height, process allowed manufacturers to print the black bar across the top of the label. The Commission grants the EnergyGuide label directly adjoining the The Commission has considered the exemption with the following Canadian EnerGuide. See 16 CFR comments received and has decided to conditions: (1) That any manufacturers 305.11(5)(i)(I). The U.S. EnergyGuide issue the conditional exemption and using this exemption must use it for all label contains operating cost amendments as detailed in this section. clothes washer models introduced information not found on the Canadian The Commission believes that there are between June 11, 2003, and December EnerGuide label. In addition, range of benefits to allowing manufacturers to 31, 2003 (they may also use it for comparability information on the FTC begin changing over to the new labels and test results at this time. The existing models that meet the new EnergyGuide label may not be the same conservation standard), and (2) the as that on the Canadian EnerGuide exemption and rule change will allow manufacturers to avoid testing their new modified EnergyGuide label must be labels. We have no evidence that these used if the new (J1) test is used to derive differences have caused confusion. As products multiple times pursuant to two test procedures for the purposes of FTC energy use information on the Alliance suggests in its comments, the EnergyGuide label for clothes washers. labeling.23 In addition, consumers will EnergyGuide’s reference to U.S. The manufacturers remain obliged to obtain information based on the new government tests alerts consumers that comply with all other Rule test sooner. The Commission also the label is intended for U.S. requirements. Manufacturers not 19 believes that the changes to the label consumers. In the long term, the specifically named in AHAM’s request Commission believes it is important to will minimize consumer confusion may use this exemption as long as they harmonize the U.S. label with the resulting from the exemption and follow the conditions specified by the Canadian label as much as possible. transition to the new test by alerting Commission.25 Given the relatively short duration of consumers that the energy use the exemption period and for the other information on some labels is derived B. Final Amendments reasons discussed above, however, the from a new test procedure. After considering the comments, the Commission is not requiring any A. Final Conditional Exemption Commission has determined to issue the specific conditions for the exemption final rule as described in this section. with regard to adjoining labels. The Commission grants AHAM’s To avoid confusion that may result from D. Benefits and Costs of the Conditional request for an exemption from the switching back to the conventional label Exemption and Amendments requirements in 16 CFR 305.5(a) and after the exemption period, the 305.11(a) only to the extent required to Commission believes that is preferable Comments allow manufacturers to: to amend the Rule to require the explanatory language on EnergyGuide The Commission asked for comments (1) Use the test procedure in 10 CFR on the economic impact of the proposed labels for all models beginning January part 430, subpart B, Appendix J1 for 1, 2004. These label changes are rule and conditional exemption, determining the energy use figure including impacts on small business. identical to those allowed by the printed on EnergyGuide labels of conditional exemption. The final AHAM stated that the proposals would clothes washers distributed between impose no additional burdens on amendments published here will minimize consumer confusion that manufacturers and would assist 22 Alliance (1) p. 2. could result from a return to the manufacturers in meeting DOE 23 As stated in the proposal, it is the conventional label at the end of the efficiency standards by January 1, Commission’s understanding that AHAM’s exemption period. 2004.20 Whirlpool added that it would members intend to test new models under the new suffer serious consequences if the FTC (J1) test procedure and use limited testing under the old (J) procedure to develop data for the purposes 24 The April 3, 2003, Federal Register document failed to implement these changes by of DOE and FTC reporting requirements during the proposed that the exemption period begin May 1, early May.21 Alliance indicated that the remainder of 2003. 64 FR at 16232. The final 2003 (see 68 FR at 16233). This date is now proposal would reduce a significant conditional exemption and rule amendments infeasible given the timing of the April 3 announced in this document apply only to FTC document’s publication. labeling requirements and do not change existing 25 Given the limited duration of this conditional 19 Alliance (1) p. 2. DOE requirements or otherwise relieve exemption, the Commission is not incorporating the 20 AHAM (3) p. 3. manufacturers from complying with DOE exemption into the text of the rule (see 16 CFR 21 Whirlpool (2) p. 5. requirements. 305.19).

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Consistent with the conditional Because the clothes washer requirements and, therefore, do not exemption, the final rule does not requirements of the Appliance Labeling require further OMB clearance.29 require an 8 inch label as proposed but rule cover a limited number of List of Subjects in 16 CFR Part 305 instead retains the 73⁄8 inch (18.73 cm.) manufacturers, most of which are large, length currently required by the Rule. In the Commission does not believe the Advertising, Energy conservation, addition, the final rule incorporates the proposed amendments or exemption Household appliances, Labeling, minor wording and format changes to will affect a substantial number of small Reporting and recordkeeping the explanatory statements described in businesses. In any event, the proposed requirements. the comment analysis and in the amendments and exemptions are VIII. Final Rule Amendments description of the conditional unlikely to have a significant economic exemption. The final rule changes are impact upon such entities, if any. ■ For the reasons set out in the preamble, printed at the end of this document. All Specifically, the proposed rule and the Federal Trade Commission amends manufacturers must follow these exemption involve minor text changes 16 CFR part 305 as follows: requirements beginning January 1, to labels already required by the rule. PART 305—[AMENDED] 2004.26 The content of these labels must be VI. Regulatory Analysis and Regulatory changed in response to new ranges of ■ 1. The authority citation for part 305 Flexibility Act Requirements comparability published by the continues to read as follows: Commission from time to time. Authority: 42 U.S.C. 6294. Under section 22 of the FTC Act, 15 Moreover, for the reasons explained ■ U.S.C. 57b, the Commission must issue earlier, the final rule amendments and 2. Amend § 305.11 by revising a regulatory analysis for a proceeding to exemption are expected to lessen the paragraph (a)(5)(i)(A) and adding new amend a rule only when it: (1) Estimates compliance burdens that would be paragraph (a)(5)(i)(L) to read as follows: that the amendment will have an annual imposed on regulated entities if they § 305.11 Labeling for covered products. effect on the national economy of were not permitted to label their $100,000,000 or more; (2) estimates that (a) * * * products in accordance with the 2004 (5) * * * the amendment will cause a substantial test procedures before those procedures change in the cost or price of certain (i) * * * officially take effect. In the (A) Headlines and texts, as illustrated categories of goods or services; or (3) Commission’s view, the amendments in the Prototype Labels in Appendix L otherwise determines that the and exemption should not have a to this Part, are standard for all labels amendment will have a significant effect significant or disproportionate impact except clothes washer labels, which upon covered entities or upon on the costs of small manufacturers and must have the text and features consumers. The Commission has retailers. described in 305.11(a)(5)(i)(L) of this determined that the exemption and part. amendments to the rule will not have Based on available information, such effects on the national economy, therefore, the Commission certifies that * * * * * on the cost of covered products, or on these amendments to the Appliance (L) Clothes washer labels must have covered parties or consumers. Labeling rule and the issuance of the the headlines and texts as illustrated in The Regulatory Flexibility Act requested exemption will not have a Prototype Label 2 of Appendix L of this (‘‘RFA’’), 5 U.S.C. 601–612, requires that significant economic impact on a Part. In particular, clothes washer labels agencies conduct analyses of the substantial number of small businesses. must have the following headline as illustrated in Prototype Label 2: anticipated economic impact of VII. Paperwork Reduction Act proposed amendments on small ‘‘Compare the energy use of this clothes businesses. The purpose of a regulatory In a 1988 notice (53 FR 22113), the washer only with other models tested flexibility analysis is to ensure that the Commission stated that the Rule using the 2004 test procedure.’’ In agency considers impact on small contains disclosure and reporting addition to the requirements for other entities and examines regulatory requirements that constitute labels, clothes washer labels must have alternatives that could achieve the ‘‘information collection requirements’’ a 10/16 inch (1.59 cm.) in height, regulatory purpose while minimizing as defined by 5 CFR 1320.7(c), the process black bar across the top that burdens on small entities. Section 605 regulation that implements the contains the following text in process of the RFA, 5 U.S.C. 605, provides that Paperwork Reduction Act.28 The yellow as illustrated in Prototype Label such an analysis is not required if the Commission noted that the rule had 2: ‘‘This model has been tested using the agency head certifies that the regulatory been reviewed and approved by the 2004 test procedure. Compare only with action will not have a significant Office of Management and Budget models displaying this statement.’’ economic impact on a substantial (‘‘OMB’’) and has been assigned OMB * * * * * number of small entities. Control No. 3084–0068 with respect to ■ 3. Appendix L to part 305 is amended There are approximately 20 the rule’s recordkeeping and reporting by revising Prototype Label 2 and manufacturers of clothes washers sold requirements until September 30, 2004, Sample Label 3 to read as follows: in the United States. Most of these subject to further renewal. The Appendix L to Part 305—Sample Labels manufacturers are relatively large.27 exemption and amendments issued in this document do not change the * * * * * 26 Prototype Label 2 in the final rule does not substance, frequency of the BILLING CODE 6750–01–C contain a specific reference to the 10/16 inch height recordkeeping, disclosure, or reporting for the black bar across the top of the label. Because 29 The exemption and final rule amendments may the final graphic may not be to scale as it appears modify the existing burden slightly by requiring in the Federal Register or the Code, specific qualify as a small business under the relevant additional information on the labels. However, references to dimensions on the prototype label threshold (i.e., 1000 employees). See http:// because the labels are already required and their may be confusing. The text of the rule clearly states www.sba.gov/size/sizetable2002.html (Small content changes from time to time when ranges of the 10/16 (1.59 cm.) inch requirement. Business Standards Matched To North American comparability are amended, we believe that the 27 Although no comments were received Industry Classification System, Code 335224, overall impact of this final rule and exemption is regarding the size of manufacturers subject to the Household Laundry Equipment Manufacturing). negligible and does not significantly alter the rule’s Rule, the Commission believes that few would 28 44 U.S.C. 3501–20. overall burden.

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* * * * * Register. The precise location of the substantial number of small entities. By direction of the Commission. event necessitating promulgation of this The term ‘‘small entities’’ comprises Donald S. Clark, safety zone and other logistical details small businesses, not-for-profit surrounding the event were not organizations that are independently Secretary. finalized until a date fewer than 30 days owned and operated and are not [FR Doc. 03–15369 Filed 6–17–03; 8:45 am] prior to the event. Delaying the effective dominant in their fields, and BILLING CODE 6750–01–P date of this rule would be contrary to governmental jurisdictions with the public interest because doing such populations of less than 50,000. would prevent the Coast Guard from For the same reasons set forth in the DEPARTMENT OF HOMELAND maintaining the safety of the above Regulatory Evaluation, the Coast SECURITY participants of the event and users of Guard certifies under 5 U.S.C. 605(b) the waterway. that this rule is not expected to have a Coast Guard significant economic impact on any Background and Purpose substantial number of entities, 33 CFR Part 165 The Coast Guard is establishing a regardless of size. [COTP San Diego 03–023] temporary safety zone on the navigable waters of the Colorado River in Assistance for Small Entities RIN 1625–AA00 Laughlin, Nevada in support of the Under section 213(a) of the Small Business Regulatory Enforcement Safety Zone; Colorado River, Laughlin, Laughlin 4th of July fireworks show. Fairness Act of 1996 (Public Law 104– NV The fireworks will be launched from an area on land, however, the fallout area 121), the Coast Guard wants to assist AGENCY: Coast Guard, DHS. will be over a section of the Colorado small entities in understanding the rule ACTION: Temporary final rule. River and a safety zone is necessary to so that they can better evaluate its provide for the safety of the spectators effects on them and participate in the SUMMARY: The Coast Guard is and users of this waterway. rulemaking process. If your small establishing a temporary safety zone business or organization is affected by near Laughlin, NV on the navigable Discussion of Rule this rule and you have questions waters of the Colorado River in support The Coast Guard proposes to establish concerning its provisions or options for of the Laughlin 4th of July fireworks this temporary rule to provide for the compliance, please contact Lieutenant show. This temporary safety zone is safety of the participants, spectators and Commander Rick Sorrell, U.S. Coast necessary to provide for the safety of the other users of the waterways. The Guard Marine Safety Office San Diego at crew, spectators, participants of the temporary safety zone is specifically (619) 683–6495. event, participating vessels and other defined as 600 yards around the point Small businesses may send comments vessels and users of the waterway. 35°09.270″ N, 114°34.222″ W. Persons on the actions of Federal employees Persons and vessels are prohibited from and vessels will be prohibited from who enforce, or otherwise determine entering into, transiting through, or entering into, transiting through, or compliance with, Federal regulations to anchoring within this safety zone unless anchoring within this safety zone unless the Small Business and Agriculture authorized by the Captain of the Port, or authorized by the Captain of the Port, or Regulatory Enforcement Ombudsman his designated representative. his designated representative. and the Regional Small Business Regulatory Fairness Boards. The DATES: This rule is effective from 8:30 Regulatory Evaluation p.m. (PDT) on July 4, 2003 through 9:30 Ombudsman evaluates these actions p.m. (PDT) on July 6, 2003. This rule is not a ‘‘significant annually and rates each agency’s regulatory action’’ under section 3(f) of ADDRESSES: Documents indicated in this responsiveness to small business. If you Executive Order 12866, Regulatory preamble as being available in the wish to comment on actions by Planning and Review, and does not docket, are part of docket [COTP San employees of the Coast Guard, call 1– require an assessment of potential costs Diego 03–023] and are available for 888–REG–FAIR (1–888–734–3247). and benefits under section 6(a)(3) of that inspection or copying at Marine Safety Order. The Office of Management and Collection of Information Office San Diego, 2716 N. Harbor Drive, Budget has not reviewed it under that This rule calls for no new collection San Diego, CA 92101–1064 between 8 Order. It is not ‘‘significant’’ under the of information under the Paperwork a.m. and 3 p.m., Monday through regulatory policies and procedures of Reduction Act of 1995 (44 U.S.C. 3501– Friday, except Federal holidays. the Department of Homeland Security 3520). FOR FURTHER INFORMATION CONTACT: (DHS). Petty Officer Austin Murai, USCG, c/o Due to the temporary safety zone’s Federalism U.S Coast Guard Captain of the Port, short duration of one hour for two days, A rule has implications for federalism telephone (619) 683–6495. its limited scope of implementation, and under Executive Order 13132, SUPPLEMENTARY INFORMATION: because vessels will have an Federalism, if it has a substantial direct opportunity to request authorization to effect on State or local governments and Regulatory Information transit, the Coast Guard expects the would either preempt State law or We did not publish a notice of economic impact of this rule to be so impose a substantial direct cost of proposed rulemaking (NPRM) for this minimal that full regulatory evaluation compliance on them. We have analyzed regulation. Under 5 U.S.C. 553(b)(B), the under the regulatory policies and this rule under that Order and have Coast Guard finds that good cause exists procedures of the DHS is unnecessary. determined that it does not have for not publishing an NPRM. In keeping implications for federalism. with the requirements of 5 U.S.C. Small Entities 553(d)(3), the Coast Guard also finds Under the Regulatory Flexibility Act Unfunded Mandates Reform Act that good cause exists for making this (5 U.S.C. 601–612), we have considered The Unfunded Mandates Reform Act regulation effective less than 30 days whether this rule would have a of 1995 (2 U.S.C. 1531–1538) requires after publication in the Federal significant economic impact on a Federal agencies to assess the effects of

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their discretionary regulatory actions. In Environment designated representative. The particular, the Act addresses actions We have analyzed this rule under designated representative may be that may result in the expenditure by a Commandant Instruction M16475.lD, contacted via VHF–FM channel 16. State, local, or tribal government, in the which guides the Coast Guard in Dated: June 6, 2003. aggregate, or by the private sector of complying with the National Robert E. McFarland, $100,000,000 or more in any one year. Environmental Policy Act of 1969 Lieutenant Commander, U.S. Coast Guard, Though this rule will not result in such (NEPA) (42 U.S.C. 4321–4370f), and Acting Captain of the Port, San Diego. expenditure, we do discuss the effects of have concluded that there are no factors [FR Doc. 03–15302 Filed 6–17–03; 8:45 am] this rule elsewhere in this preamble. in this case that would limit the use of BILLING CODE 4910–15–P Taking of Private Property a categorical exclusion under section 2.B.2 of the Instruction. Therefore, this This rule will not affect a taking of rule is categorically excluded, under DEPARTMENT OF DEFENSE private property or otherwise have figure 2–1, paragraph (34)(g), of the taking implications under Executive Instruction, from further environmental Corps of Engineers, Department of the Order 12630, Governmental Actions and documentation. Army Interference with Constitutionally Under figure 2–1, paragraph (34)(g), of Protected Property Rights. the Instruction, an ‘‘Environmental 33 CFR Part 203 Analysis Check List’’ and a ‘‘Categorical RIN 0710–AA47 Civil Justice Reform Exclusion Determination’’ are not required for this rule. This rule meets applicable standards Natural Disaster Procedures: in sections 3(a) and 3(b)(2) of Executive List of Subjects in 33 CFR Part 165 Preparedness, Response, and Order 12988, Civil Justice Reform, to Recovery Activities of the Corps of Harbors, Marine safety, Navigation Engineers; Correction minimize litigation, eliminate (water), Reporting and recordkeeping ambiguity, and reduce burden. requirements, Security measures, AGENCY: Army Corps of Engineers, DoD. Protection of Children Waterways. ACTION: Final rule; correction. ■ For the reasons discussed in the We have analyzed this rule under SUMMARY: The Corps promulgated a preamble, the Coast Guard amends 33 final rule to revise 33 CFR part 203. This Executive Order 13045, Protection of CFR part 165 as follows: Children from Environmental Health file rule was published in the Federal Register on April 21, 2003, with Risks and Safety Risks. This rule is not PART 165—REGULATED NAVIGATION inadvertent errors in section 203.62. The an economically significant rule and AREAS AND LIMITED ACCESS AREAS does not create an environmental risk to final rule completes the rulemaking health or risk to safety that may ■ 1. The authority citation for part 165 process initiated on February 26, 2002, disproportionately affect children. continues to read as follows: with publication of the proposed rule to revise 33 CFR part 203, which Authority: 33 U.S.C. 1231; 50 U.S.C. 191; Indian Tribal Governments and 33 CFR 1.05–1(g), 6.04–1, 6.04–6, and implements Pub. L. 84–99. The revisions are necessary to reflect current This rule does not have tribal 160.5; Department of Homeland Security Delegation No. 0170. policy, add features required by the implications under Executive Order Water Resources Development Act of ■ 13175, Consultation and Coordination 2. From 8:30 p.m. on July 4, 2003 1996 (WRDA 96), and streamline certain with Indian Tribal Governments, through 9:30 p.m. on July 6, 2003 add a procedures concerning Corps authority because it does not have a substantial new § 165.T11–042 to read as follows: addressing disaster preparedness, direct effect on one or more Indian § 165.T11–042 Safety Zone; Colorado response, and recovery activities. tribes, on the relationship between the River, Laughlin, Nevada. WRDA 96 additions include the option Federal Government and Indian tribes, (a) Location. The temporary safety to provide nonstructural alternatives in or on the distribution of power and zone is specifically defined as 600 yards lieu of structural repairs to levees responsibilities between the Federal around the point 35°09.270′ N, damaged by flood events, and the Government and Indian tribes. 114°34.222′ W. provision of a levee owner’s manual. Energy Effects (b) Enforcement period. This section Other significant changes include will be enforced from 8:30 p.m. to 9:30 expansion of investigation ability for We have analyzed this rule under p.m. (PDT) on July 4, 2003 and from potential Advance Measures work, and Executive Order 13211, Actions 8:30 p.m. through 9:30 p.m. on July 6, a streamlined approach for requests for Concerning Regulations That 2003. If the event concludes prior to the assistance from Native American tribes Significantly Affect Energy Supply, scheduled termination time, the Captain and Alaska Native Corporations. Distribution, or Use. We have of the Port will cease enforcement of DATES: This rule became effective on determined that it is not a ‘‘significant this safety zone and will announce that May 21, 2003. energy action’’ under that Order because fact via Broadcast Notice to Mariners. FOR FURTHER INFORMATION CONTACT: Mr. it is not a ‘‘significant regulatory action’’ (c) Regulations. In accordance with Jeffrey D. Jensen, Headquarters, U.S. under Executive Order 12866 and is not the general regulations in § 165.23 of Army Corps of Engineers, Civil likely to have a significant adverse effect this part, entry into, transit through, or Emergency Management Branch, on the supply, distribution, or use of anchoring within this zone by all CECW–HS–E, at (202) 761–4561. energy. The Administrator of the Office vessels is prohibited, unless authorized SUPPLEMENTARY INFORMATION: of Information and Regulatory Affairs by the Captain of the Port, or his I. Background. Section 203.62 is has not designated it as a significant designated representative. Mariners corrected by redesignation of the second energy action. Therefore, it does not requesting permission to transit through paragraph (d) ‘‘Guidance’’ as paragraph require a Statement of Energy Effects the safety zone may request (e) and paragraph (e) ‘‘Guidance- under Executive Order 13211. authorization to do so from the transport of water’’ as paragraph (f) and

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paragraph (f) ‘‘Request for assistance’’ as determines, due to drought conditions, (C) As a result of the drought, a paragraph (g). has an inadequate water supply that is private business could not construct the Dated: June 2, 2003. causing, or is likely to cause, a well within a reasonable time. Lawrence A. Lang, substantial threat to the health and (iv) The applicant has secured the welfare of the inhabitants of the necessary funding for well construction Acting Chief, Operations Division, Directorate of Civil Works. impacted area, including the threat of from commercial or other sources, or damage or loss of property. has entered into a contract to pay to the ■ Accordingly, 33 CFR part 203 section (3) Eligible applicant. Any rancher, United States the reasonable cost of 203.62 is correctly revised as follows: farmer or political subdivision within a such construction with interest over a PART 203—EMERGENCY designated drought-distressed area that period of years, not to exceed 30, as the EMPLOYMENT OF ARMY AND OTHER is experiencing an inadequate supply of Secretary of the Army deems RESOURCES, NATURAL DISASTER water due to drought. appropriate. PROCEDURES (4) Farmer or rancher. An individual (v) The applicant has obtained all who realizes at least one-third of his or necessary Federal, State and local § 203.62 Drought assistance. her gross annual income from permits. (a) Authority. The Chief of Engineers, agricultural sources, and is recognized (2) The financing of the cost of acting for the Secretary of the Army, has in the community as a farmer or construction of a well by the Corps the authority under certain statutory rancher. A farming partnership, under this authority should be secured conditions to construct wells for corporation, or similar entity engaged in by the project applicant. farmers, ranchers, political farming or ranching, which receives its (3) The project applicant will provide subdivisions, and to transport water to majority income from such activity, is the necessary assurances of local political subdivisions, within areas also considered to be a farmer or cooperation by signing a Cooperation determined to be drought-distressed. rancher, and thus an eligible applicant. Agreement (subpart G of this part) prior (b) General policy. (1) It is a non- (5) Political subdivision. A city, town, to the start of Corps work under this Federal responsibility for providing an borough, county, parish, district, authority. adequate supply of water to local association, or other public body created (4) Equipment owned by the United inhabitants. Corps assistance to provide by, or pursuant to, Federal or State law, States will be utilized to the maximum emergency water supplies will only be having jurisdiction over the water extent possible in exercising the considered when non-Federal interests supply of such public body. authority to drill wells, but can only be have exhausted reasonable means for (6) Reasonable cost. In connection used when commercial firms cannot securing necessary water supplies, with the Corps construction of a well, provide comparable service within the including assistance and support from means the lesser of: time needed to prevent the applicant from suffering significantly increased other Federal agencies. (i) The cost of the Chief of Engineers hardships from the effects of an (2) Before Corps assistance is to construct a well in accordance with inadequate water supply. considered under this authority, the these regulations, exclusive of: (f) Guidance-transport of water. (1) applicability of other Federal assistance (A) The cost of transporting Assistance to an applicant in the authorities must be evaluated. If these equipment used in the construction of transportation of water may be provided programs cannot provide the needed wells, and if: assistance, then maximum coordination (B) The cost of investigation and should be made with appropriate (i) It is in response to a written report preparation to determine the request by a political subdivision for agencies in implementing Corps suitability to construct a well, or, assistance. transportation of water. (ii) The cost to a private business of (ii) The applicant is located within an (c) Governor’s request. A letter signed constructing such a well. by the Governor, requesting Corps area that the Secretary of the Army has (7) State. Any State, the District of determined to be drought-distressed. assistance and addressing the State’s Columbia, the Commonwealth of Puerto commitments and capabilities with (iii) The Secretary of the Army has Rico, the Virgin Islands, Guam, made a determination that, as a result of response to the emergency situation, is Northern Marianas Islands, American required. All requests should identify the drought, the applicant has an Samoa, and the Trust Territory of the inadequate supply of water for human the following information: Pacific Islands. (1) A description of local and State consumption, and the applicant cannot (e) Guidance—construction of wells. efforts undertaken. A verification that obtain water. (1) Assistance to an eligible applicant all available resources have been (2) Transportation of water by for the construction of a well may be committed, to include National Guard vehicles, small diameter pipe line, or provided on a cost-reimbursable basis if: assets. other means will be at 100 percent (2) Identification of the specific needs (i) It is in response to a written Federal cost. of the State, and the required Corps request by a farmer, rancher, or political (3) Corps assistance in the assistance. subdivision for construction of a well transportation of emergency water (3) Identification of the additional under Public Law 84–99. supplies will be provided only in commitments to be accomplished by the (ii) The applicant is located within an connection with water needed for State. area that the Secretary of the Army has human consumption. Assistance will (4) Identification of the project determined to be drought-distressed. not be provided in connection with sponsor(s). (iii) The Secretary of the Army has water needed for irrigation, recreation, (d) Definitions applicable to this made a determination that: or other non-life supporting purposes, section. (A) The applicant, as a result of the or livestock consumption. (1) Construction. This term includes drought, has an inadequate supply of (4) Corps assistance will not include initial construction, reconstruction, or water. the purchase of water, nor the cost of repair. (B) An adequate supply of water can loading or discharging the water into or (2) Drought-distressed area. An area be made available to the applicant from any Government conveyance, to that the Secretary of the Army through the construction of a well. include Government-leased conveyance.

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(5) Equipment owned by the United allows certain noninteractive digital 260.7, because the CARP had not States will be utilized to the maximum audio services to transmit sound considered these issues, leaving the extent possible in exercising the recordings under a compulsory license, record devoid of any evidence upon authority to transport water, consistent provided that the services pay a which to fashion any terms concerning with lowest total Federal cost. reasonable royalty fee and comply with the collection and distribution of the (g) Request for assistance. A written the terms of the statutory license. royalty fees. Id. at 536. request must be made to the district Among the categories of services that In 2001, RIAA petitioned the commander with Civil Works may use the section 114 license are Copyright Office to adopt new terms responsibility for the affected area. preexisting subscription services 1 of that would govern the RIAA collective. Upon receipt of a written request, the which there are only three: Digital Cable These terms were to be adopted appropriate State and Federal agencies Radio Associates, now known as Music pursuant to § 251.63(b) which allows will be notified, and coordination will Choice; DMX Music, Inc. (‘‘DMX’’); and the Librarian of Congress to adopt continue as appropriate throughout the Muzak, L.P. (‘‘Muzak’’). proposed terms that are the result of assistance. In 1998, the Librarian of Congress settlement negotiations, provided that adopted final rates and terms applicable no person with a substantial interest [FR Doc. 03–15305 Filed 6–17–03; 8:45 am] to the preexisting services after a and an intent to participate in a CARP BILLING CODE 3710–92–P hearing before a copyright arbitration proceeding files an objection. royalty panel (‘‘CARP’’). See 63 FR Accordingly, the Copyright Office 25394 (May 8, 1998). In that proceeding, published the proposed terms in the LIBRARY OF CONGRESS the parties proposed a term which gave Federal Register and requested public the RIAA the responsibility for comment. 66 FR 38226 (July 23, 2001). Copyright Office collecting and distributing the royalty In response to this notice, the American fees to all copyright owners. Id. at Federation of Musicians (‘‘AFM’’) and 37 CFR Part 260 25397. The Librarian adopted this term, the American Federation of Television [Docket No. 96–5 CARP DSTRA] then crafted additional regulations that and Radio Artists (‘‘AFTRA’’) filed a afforded copyright owners a means to Notice of Intent to Participate and Determination of Reasonable Rates verify the accuracy of the royalty objections to certain of the proposed and Terms for the Digital Performance payments made by the RIAA collective,2 terms. Shortly thereafter, RIAA began of Sound Recordings established the value of each discussions with AFTRA and AFM performance, specified the nature of the regarding their objections, and the AGENCY: Copyright Office, Library of matter was held in abeyance, pending Congress. costs that RIAA may deduct from the royalty fees prior to distribution, and set the outcome of those discussions. ACTION: Final regulation. forth a procedure for handling royalty In the meantime, Congress passed the SUMMARY: The Copyright Office is fees in the case where the collective is Small Webcaster Settlement Act of 2002 announcing the final regulations that unable to identify or locate a copyright (‘‘SWSA’’), Public Law 107–321, 116 will govern SoundExchange, an owner who is entitled to receive Stat. 2780, which, among other things, unincorporated division of the royalties collected under the statutory amended 17 U.S.C. 114(g) in two Recording Industry Association of license. important ways that bear directly on America, Inc., when it functions as the RIAA appealed both the rate and the two key issues raised in this proceeding. First, the SWSA provides for direct designated agent for the purpose of additional terms announced in the payment to featured recording artists receiving royalty payments and Librarian’s determination and final and to the administrators of the escrow statements of accounts from nonexempt order. See, Recording Industry Ass’n v. accounts provided for in 17 U.S.C. subscription digital transmission Librarian of Congress, 176 F.3d 528 114(g)(2)(B)&(C). Second, the act allows services which make digital (D.C. Cir. 1999). The United States Court a designated agent, prior to the transmissions of sound recordings of Appeals for the District of Columbia distribution of the royalty receipts, to under a statutory license. Circuit upheld the rate and found that the Librarian had the authority to deduct reasonable costs incurred by that DATES: Effective Date: July 18, 2003. agent in the administration of those Applicability Date: The regulations impose additional terms on copyright owners or their agents. However, it receipts, including, but not limited to, apply to the license period which began costs associated with the collection and on November 1, 1995. remanded for further consideration certain terms imposed on RIAA under distribution of the royalty fees and the FOR FURTHER INFORMATION CONTACT: 37 CFR 260.2(d), 260.3(d), 260.6(b), and costs incurred in participating in David O. Carson, General Counsel, or negotiations or arbitration proceedings Tanya M. Sandros, Senior Attorney, 1 A ‘‘preexisting subscription service’’ is defined under sections 112 and 114. Copyright Arbitration Royalty Panel, as: Because of these changes in the law, P.O. Box 70977, Southwest Station, a service that performs sound recordings by RIAA revised its proposed amendments Washington, DC 20024. Telephone: means of noninteractive audio-only subscription to 37 CFR part 260 to conform the terms (202) 707–8380. Telefax: (202) 252– digital audio transmissions, which was in existence and was making such transmissions to the public in question to the new law and, in doing 3423. for a fee on or before July 31, 1998, and may include so, it addressed the concerns of AFM SUPPLEMENTARY INFORMATION: a number of limited number of sample channels and AFTRA. However, the proposed representative of the subscription service that are rules could not be adopted until all Background made available on a nonsubscription basis in order to promote the subscription service. interested parties had an opportunity to Section 106(6) of the Copyright Act, 17 U.S.C. 114(j)(11). comment. Therefore, pursuant to title 17 of the United States Code, gives 2 In November 2000, RIAA formed § 251.63(b) of the CARP rules, the copyright owners of sound recordings ‘‘SoundExchange,’’ an unincorporated division of Library published in the Federal an exclusive right to perform their RIAA, to administer statutory licenses, including its Register the proposed terms and sought responsibilities under the Librarian’s May 8 Order. copyrighted work publicly by means of See, Revised RIAA petition to Establish Terms comment from any party with a a digital audio transmission. This right Governing SoundExchange at 1 n.1 (March 12, substantial interest in this proceeding. is limited by section 114(d), which 2003). 68 FR 19482 (April 21, 2003).

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Having received no objections to the allocate their shares of the royalty paperwork, which was performed in the recently proposed terms, the Librarian is payments made by any Licensee among ordinary course of business according to adopting the proposed amendments as themselves on an alternative basis. generally accepted auditing standards final regulations. The proposed terms Parties entitled to receive payments by an independent auditor, shall serve shall govern SoundExchange, the under 17 U.S.C. 114(g)(2) may agree as an acceptable verification procedure collecting rights entity that was formed with the designated agent upon for all interested parties. from the designated RIAA collective, in payment protocols to be used by the (f) Costs of the verification procedure. its capacity as the sole agent designated designated agent that provide for The interested parties requesting the to receive royalty payments from the alternative arrangements for the verification procedure shall pay for the three subscription services that were payment of royalties consistent with the cost of the verification procedure, parties to this proceeding. Terms percentages in 17 U.S.C. 114(g)(2). unless an independent auditor governing the administrative functions (d) The designated agent may deduct concludes that there was an of any future collective or the from the payments made by Licensees underpayment of five (5) percent or designation of alternative agents shall be under § 260.2, prior to the distribution more, in which case, the designated decided in future rate adjustment of such payments to any person or agent shall bear the costs of the proceedings either through negotiations entity entitled thereto, all incurred costs verification procedure. or after a hearing before a CARP based permitted to be deducted under 17 (g) Interested parties. For purposes of upon a fully developed written record. U.S.C. 114(g)(3); Provided, however, this section, interested parties are those See, e.g., 67 FR 45239 (July 8, 2002). that any party entitled to receive royalty individuals or entities who are entitled payments according to 17 U.S.C. to receive royalty payments pursuant to List of Subjects in 37 CFR Part 260 114(g)(2) may agree to permit the 17 U.S.C. 114(g)(2), or their designated Copyright, Digital audio designated agent to deduct any agents. transmissions, Performance right, Sound additional costs. recordings. (e) Commencing June 1, 1998, and § 260.7 [Amended] until such time as a new designation is ■ 5. Section 260.7 is amended by Final Regulation made, SoundExchange, which currently removing the word ‘‘collecting’’ after the ■ For the foregoing reasons, the Library is an unincorporated division of the phrase ‘‘If the designated’; by removing amends part 260 of 37 CFR as follows: Recording Industry Association of the word ‘‘collecting’’ each place it America, Inc., shall be the agent that appears and adding the word PART 260—USE OF SOUND receives royalty payments and ‘‘designated ‘‘ in its place; and in the last RECORDINGS IN A DIGITAL statements of account under this part sentence, by removing the word ‘‘fees’’ PERFORMANCE 260 and shall continue to be designated and adding the word ‘‘payments’’ in its as such if it should be separately place. ■ 1. The authority citation for part 260 incorporated. Dated: May 27, 2003. continues to read as follows: ■ 4. Section 260.6 is revised to read as Marybeth Peters, Authority: 17 U.S.C. 114, 801(b)(1). follows: Register of Copyrights. § 260.2 [Amended] § 260.6 Verification of royalty payments. Approved by: ■ 2. In § 260.2, remove paragraph (d). (a) General. This section prescribes James H. Billington, ■ 3. Section 260.3 is amended by general rules pertaining to the method The Librarian of Congress. revising paragraphs (c), (d), and (e) to of verification of the payment of royalty [FR Doc. 03–15384 Filed 6–17–03; 8:45 am] read as follows: fees by the designated agent to BILLING CODE 1410–33–P interested parties; Provided, however, § 260.3 Terms for making payments of that the designated agent and any royalty fees. interested person may agree as to an ENVIRONMENTAL PROTECTION * * * * * alternative method of verification. AGENCY (c) The agent designated to receive the (b) Frequency of verification. royalty payments and the statements of Interested parties may conduct a single 40 CFR Part 52 account shall have the responsibility of audit of the designated agent during any making further distribution of these given calendar year and no calendar [MO 180–1180a; FRL–7513–9] payments to those parties entitled to year shall be subject to audit more than Approval and Promulgation of receive such payments according to the once. Implementation Plans; State of provisions set forth at 17 U.S.C. (c) Notice of intent to audit. Interested Missouri 114(g)(2); Provided that the designated parties must file with the Copyright agent shall only be responsible for Office a notice of intent to audit the AGENCY: Environmental Protection making distributions to those parties designated agent. Such notice of intent Agency (EPA). who provide the designated agent with shall also be served at the same time on ACTION: Direct final rule. such information as is necessary to the designated agent to be audited. identify and pay the correct recipient for Within 30 days of the filing of the notice SUMMARY: EPA is announcing it is such payments. The agent shall of intent, the Copyright Office shall approving a revision to the Missouri distribute royalty payments on a publish in the Federal Register a notice State Implementation Plan (SIP) which reasonable basis that values all announcing such filing. pertains to the rescission of two rules performances by a Licensee equally (d) Retention of records. The which control the emissions of based upon the information provided by interested party requesting the Perchloroethylene Dry Cleaning the Licensee pursuant to the regulations verification procedure shall retain the Installations in the Kansas City and St. governing records of use of report of the verification for a period of Louis areas. This revision will rescind performances by Licensees; Provided, three years. two rules that have been superseded by however, that parties who have (e) Acceptable verification procedure. the statewide Maximum Achievable designated the agent may agree to An audit, including underlying Control Technology rule. There is no

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relaxation of controls by rescinding monitoring networks, and modeling superseded by the state-adopted these rules. Approval of this revision demonstrations. Maximum Achievable Control will eliminate redundancy and Technology (MACT) rule 10 CSR 10– What Is the Federal Approval Process conflicting requirements. 6.075. The latter rule incorporates by for a SIP? DATES: This direct final rule will be reference the EPA rule, 40 CFR part 63, effective August 18, 2003, unless EPA In order for state regulations to be subpart M. As such, prior to this action, receives adverse comments by July 18, incorporated into the Federally- there were three Federally enforceable 2003. If adverse comments are received, enforceable SIP, states must formally regulations for the Perchloroethylene EPA will publish a timely withdrawal of adopt the regulations and control Dry Cleaning Installations. the direct final rule in the Federal strategies consistent with state and An EPA review concluded that the Register informing the public that the Federal requirements. This process rescission of these two Missouri rules rule will not take effect. generally includes a public notice, does not result in any increase in public hearing, public comment period, emissions. There is no relaxation of ADDRESSES: Comments may be mailed to and a formal adoption by a state- controls by rescinding rules 10 CSR 10– Amy Algoe-Eakin, Environmental authorized rulemaking body. 2.280 and 10 CSR 10–5.320. Sources Protection Agency, Air Planning and Once a state rule, regulation, or subject to the rule must still meet a Development Branch, 901 North 5th control strategy is adopted, the state control technology at least as stringent Street, Kansas City, Kansas 66101, or E- submits it to us for inclusion into the as RACT. Therefore, there are no mail her at [email protected]. SIP. We must provide public notice and adverse impacts on the ability of the Copies of documents relative to this seek additional public comment Kansas City and St. Louis areas to action are available for public regarding the proposed Federal action maintain the 1-hour ozone standard. inspection during normal business on the state submission. If adverse The controls on subject dry cleaning hours at the above-listed Region 7 comments are received, they must be installations will remain enforceable by location. The interested persons addressed prior to any final Federal the state under 10 CSR 10–6.075, and by wanting to examine these documents action by us. EPA, under 40 CFR part 63, subpart M. should make an appointment with the All state regulations and supporting Approval of this revision will eliminate office at least 24 hours in advance. information approved by EPA under redundancy and conflicting FOR FURTHER INFORMATION CONTACT: section 110 of the CAA are incorporated requirements. Amy Algoe-Eakin at (913) 551–7942. into the Federally-approved SIP. The state submittal has met the public SUPPLEMENTARY INFORMATION: Records of such SIP actions are notice requirements for SIP submissions Throughout this document whenever maintained in the Code of Federal in accordance with 40 CFR 51.102. The ‘‘we,’’ ‘‘us,’’ or ‘‘our’’ is used, we mean Regulations (CFR) at Title 40, Part 52, submittal also satisfied the EPA. This section provides additional entitled ‘‘Approval and Promulgation of completeness criteria of 40 CFR part 51, information by addressing the following Implementation Plans.’’ The actual state appendix V. In addition, as explained questions: regulations which are approved are not above and in more detail in the reproduced in their entirety in the CFR What is a SIP? technical support document which is What is the Federal approval process for a outright but are ‘‘incorporated by part of this document, the revision SIP? reference,’’ which means that we have meets the substantive SIP requirements What does Federal approval of a state approved a given state regulation with of the CAA, including section 110 and regulation mean to me? a specific effective date. implementing regulations. What is being addressed in this document? Have the requirements for approval of a SIP What Does Federal Approval of a State What Action Is EPA Taking? revision been met? Regulation Mean to Me? We are approving the revision to What action is EPA taking? Enforcement of the state regulation rescind Missouri rule 10 CSRS 10– What Is a SIP? before and after it is incorporated into 2.280, Control of Emissions from the Federally-approved SIP is primarily Perchloroethylene Dry Cleaning Section 110 of the Clean Air Act a state responsibility. However, after the Installations and Missouri rule 10 CSR (CAA) requires states to develop air regulation is Federally approved, we are 10–5.320, Control of Emissions from pollution regulations and control authorized to take enforcement action Perchloroethylene Dry Cleaning strategies to ensure that state air quality against violators. Citizens are also Installations from the Missouri SIP. meets the national ambient air quality offered legal recourse to address We are processing this action as a standards established by EPA. These violations as described in section 304 of final action because the revisions make ambient standards are established under the CAA. routine changes to the existing rules section 109 of the CAA, and they which are noncontroversial. Therefore, currently address six criteria pollutants. What Is Being Addressed in This we do not anticipate any adverse These pollutants are: carbon monoxide, Document? comments. Please note that if EPA nitrogen dioxide, ozone, lead, Missouri rule 10 CSR 10–2.280 and receives adverse comment on part of particulate matter, and sulfur dioxide. Missouri rule 10 CSR 10–5.320 relate to this rule and if that part can be severed Each state must submit these the control of emissions from from the remainder of the rule, EPA may regulations and control strategies to us Perchloroethylene Dry Cleaning adopt as final those parts of the rule that for approval and incorporation into the Installations for the Kansas City and St. are not the subject of an adverse Federally-enforceable SIP. Louis areas, respectively. These rules comment. Each Federally-approved SIP protects had been approved by EPA as air quality primarily by addressing air representing Reasonably Available Statutory and Executive Order Reviews pollution at its point of origin. These Control Technology (RACT) in the Under Executive Order 12866 (58 FR SIPs can be extensive, containing state Kansas City and St. Louis areas. 51735, October 4, 1993), this action is regulations or other enforceable This revision to Missouri’s SIP will not a ‘‘significant regulatory action’’ and documents and supporting information rescind rules 10 CSR 10–2.280 and 10 therefore is not subject to review by the such as emission inventories, CSR 10–5.320, which have been Office of Management and Budget. For

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this reason, this action is also not Technology Transfer and Advancement ■ b. In the table to paragraph (c) by subject to Executive Order 13211, Act of 1995 (15 U.S.C. 272 note) do not removing the entries under Chapter 2 for ‘‘Actions Concerning Regulations That apply. This rule does not impose an 10–2.280 and under Chapter 5 for 10– Significantly Affect Energy Supply, information collection burden under the 5.320. Distribution, or Use’’ (66 FR 28355, May provisions of the Paperwork Reduction The revision reads as follows: 22, 2001). This action merely approves Act of 1995 (44 U.S.C. 3501 et seq.). state law as meeting Federal The Congressional Review Act, 5 § 52.1320 Identification of plan. requirements and imposes no additional U.S.C. 801 et seq., as added by the Small * * * * * requirements beyond those imposed by Business Regulatory Enforcement (b) * * * state law. Accordingly, the Fairness Act of 1996, generally provides (3) Copies of the materials Administrator certifies that this rule that before a rule may take effect, the incorporated by reference may be will not have a significant economic agency promulgating the rule must inspected at the Environmental impact on a substantial number of small submit a rule report, which includes a Protection Agency, Region VII, Air entities under the Regulatory Flexibility copy of the rule, to each House of the Planning and Development Branch, 901 Act (5 U.S.C. 601 et seq.). Because this Congress and to the Comptroller General North 5th Street, Kansas City, Kansas rule approves pre-existing requirements of the United States. EPA will submit a 66101; the Office of Federal Register, under state law and does not impose report containing this rule and other 800 North Capitol Street, NW., Suite any additional enforceable duty beyond required information to the U.S. Senate, 700, Washington, DC; or at the EPA Air that required by state law, it does not the U.S. House of Representatives, and and Radiation Docket and Information contain any unfunded mandate or the Comptroller General of the United Center, Room B–108, 1301 Constitution significantly or uniquely affect small States prior to publication of the rule in Avenue, NW. (Mail Code 6102T), governments, as described in the the Federal Register. A major rule Washington, DC 20460. Unfunded Mandates Reform Act of 1995 cannot take effect until 60 days after it * * * * * (Public Law 104–4). is published in the Federal Register. [FR Doc. 03–15251 Filed 6–17–03; 8:45 am] This rule also does not have tribal This action is not a ‘‘major rule’’ as BILLING CODE 6560–50–P implications because it will not have a defined by 5 U.S.C. 804(2). substantial direct effect on one or more Under section 307(b)(1) of the CAA, Indian tribes, on the relationship petitions for judicial review of this ENVIRONMENTAL PROTECTION between the Federal Government and action must be filed in the United States AGENCY Indian tribes, or on the distribution of Court of Appeals for the appropriate power and responsibilities between the circuit by August 18, 2003. Filing a 40 CFR Part 180 Federal Government and Indian tribes, petition for reconsideration by the [OPP–2003–0155; FRL–7308–8] as specified by Executive Order 13175 Administrator of this final rule does not (65 FR 67249, November 9, 2000). This affect the finality of this rule for the Glyphosate; Pesticide Tolerance action also does not have Federalism purposes of judicial review nor does it implications because it does not have extend the time within which a petition AGENCY: Environmental Protection substantial direct effects on the States, for judicial review may be filed, and Agency (EPA). on the relationship between the national shall not postpone the effectiveness of ACTION: Final rule. government and the States, or on the such rule or action. This action may not distribution of power and be challenged later in proceedings to SUMMARY: This regulation establishes a responsibilities among the various enforce its requirements. (See section tolerance for residues of glyphosate in levels of government, as specified in 307(b)(2).) or on corn, field, forage at 6.0 parts per Executive Order 13132 (64 FR 43255, million (ppm) and reduces the tolerance August 10, 1999). This action merely List of Subjects 40 CFR Part 52 on grain, aspirated fractions from 200 approves a state rule implementing a Environmental protection, Air ppm to 100 ppm. Monsanto Company Federal standard and does not alter the pollution control, Carbon monoxide, requested this tolerance under the relationship or the distribution of power Incorporation by reference, Federal Food, Drug, and Cosmetic Act and responsibilities established in the Intergovernmental relations, Nitrogen (FFDCA), as amended by the Food CAA. This rule also is not subject to dioxide, Particulate matter, Ozone, Quality Protection Act of 1996 (FQPA). Executive Order 13045, ‘‘Protection of Reporting and recordkeeping DATES: This regulation is effective June Children from Environmental Health requirements, Sulfur dioxide, Volatile 18, 2003. Objections and requests for Risks and Safety Risks’’ (62 FR 19885, organic compounds. hearings, identified by docket ID April 23, 1997), because it is not Dated: June 8, 2003. number OPP–2003–0155, must be economically significant. received on or before August 18, 2003. In reviewing SIP submissions, EPA’s James B. Gulliford, role is to approve state choices, Regional Administrator, Region 7. ADDRESSES: Written objections and provided that they meet the criteria of ■ Chapter I, title 40 of the Code of hearing requests may be submitted the CAA. In this context, in the absence Federal Regulations is amended as electronically, by mail, or through hand of a prior existing requirement for the follows: delivery/courier. Follow the detailed State to use voluntary consensus instructions as provided in Unit VI. of standards (VCS), EPA has no authority PART 52—[AMENDED] the SUPPLEMENTARY INFORMATION. to disapprove a SIP submission for ■ 1. The authority citation for part 52 FOR FURTHER INFORMATION CONTACT: Jim failure to use VCS. It would thus be continues to read as follows: Tompkins, Registration Division inconsistent with applicable law for (7505C), Office of Pesticide Programs, EPA, when it reviews a SIP submission, Authority: 42 U.S.C. 7401 et seq. Environmental Protection Agency, 1200 to use VCS in place of a SIP submission Subpart AA—Missouri Pennsylvania Ave., NW., Washington, that otherwise satisfies the provisions of DC 20460–0001; telephone number: the CAA. Thus, the requirements of ■ 2. Section 52.1320 is amended by: (703) 305–5697; e-mail address: section 12(d) of the National ■ a. Revising paragraph (b)(3); and [email protected].

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SUPPLEMENTARY INFORMATION: www.access.gpo.gov/nara/cfr/ defines ‘‘safe’’ to mean that ‘‘there is a cfrhtml_00/Title_40/40cfr180_00.html, a reasonable certainty that no harm will I. General Information beta site currently under development. result from aggregate exposure to the A. Does this Action Apply to Me? An electronic version of the public pesticide chemical residue, including docket is available through EPA’s You may be potentially affected by all anticipated dietary exposures and all electronic public docket and comment this action if you are an agricultural other exposures for which there is system, EPA Dockets. You may use EPA producer, food manufacturer, or reliable information.’’ This includes Dockets at http://www.epa.gov/edocket/ exposure through drinking water and in pesticide manufacturer. Potentially to submit or view public comments, residential settings, but does not include affected entities may include, but are access the index listing of the contents occupational exposure. Section not limited to: of the official public docket, and to 408(b)(2)(C) of the FFDCA requires EPA • Crop production (NAIC 111) access those documents in the public to give special consideration to • Animal production (NAIC 112) docket that are available electronically. exposure of infants and children to the • Food manufacturing (NAIC 311) Although not all docket materials may pesticide chemical residue in • Pesticide manufacturing (NAIC be available electronically, you may still establishing a tolerance and to ‘‘ensure 32532) access any of the publicly available that there is a reasonable certainty that This listing is not intended to be docket materials through the docket no harm will result to infants and exhaustive, but rather provides a guide facility identified in Unit I.B.1. Once in children from aggregate exposure to the for readers regarding entities likely to be the system, select ‘‘search,’’ then key in pesticide chemical residue. . . .’’ affected by this action. Other types of the appropriate docket ID number. EPA performs a number of analyses to entities not listed in this unit could also determine the risks from aggregate II. Background and Statutory Findings be affected. The North American exposure to pesticide residues. For Industrial Classification System In the Federal Register of April 17, further discussion of the regulatory (NAICS) codes have been provided to 2002 (67 FR 18894) (FRL–6830–5), EPA requirements of section 408 of the assist you and others in determining issued a notice pursuant to section 408 FFDCA and a complete description of whether this action might apply to of the Federal Food, Drug, and Cosmetic the risk assessment process, see the final certain entities. To determine whether Act (FFDCA), 21 U.S.C. 346a, as rule on Bifenthrin Pesticide Tolerances you or your business may be affected by amended by the Food Quality Protection (62 FR 62961, November 26, 1997) this action, you should carefully Act of 1996 (FQPA) (Public Law 104– (FRL–5754–7). examine the applicability provisions in 170), announcing the filing of a number Unit II. If you have any questions of pesticide petitions by Monsanto, 600 III. Aggregate Risk Assessment and regarding the applicability of this action 13th St., NW., Suite 660, Washington, Determination of Safety to a particular entity, consult the person DC 20005. The notice included a Consistent with section 408(b)(2)(D) listed under FOR FURTHER INFORMATION summary of the petition prepared by of the FFDCA, EPA has reviewed the CONTACT. Monsanto, the registrant. Comments available scientific data and other B. How Can I Get Copies of this received in the public docket with relevant information in support of this Document and Other Related respect to the Notice of Filing were action. EPA has sufficient data to assess Information? addressed in the final rule publication the hazards of and to make a in the Federal Register of September 27, determination on aggregate exposure, 1. Docket. EPA has established an 2002 (67 FR 60934) (FRL–7200–2), and consistent with section 408(b)(2) of the official public docket for this action will not be presented again here in this FFDCA, for a tolerance for residues of under docket identification (ID) number final rule. glyphosate on grain, aspirated fractions OPP–2003–0155. The official public The petitions requested that 40 CFR at 100 ppm and corn, field, forage at 6.0 docket consists of the documents 180.364 be amended by establishing a ppm. EPA’s assessment of exposures specifically referenced in this action, tolerance for residues of the herbicide and risks associated with establishing any public comments received, and glyphosate in or on corn, field, forage at glyphosate tolerances for a number of other information related to this action. 6 ppm; by reducing the tolerance on feed commodities was performed Although a part of the official docket, aspirated grain fractions from 200 ppm previously and was presented in detail the public docket does not include to 100 ppm. In addition, the Agency is in the final rule on Glyphosate Pesticide Confidential Business Information (CBI) taking this opportunity to change the Tolerances (67 FR 60934, September 27, or other information whose disclosure is commodity definition from aspirated 2002) (FRL–7200–2). Given that higher restricted by statute. The official public grain fractions to grain, aspirated tolerances for glyphosate are currently docket is the collection of materials that fractions; deleting the existing tolerance established for other significant animal is available for public viewing at the for soybean, aspirated grain fractions at feed commodities, the dietary burden Public Information and Records 50.0 ppm since these soybean fractions for cattle, poultry, and hogs will be Integrity Branch (PIRIB), Rm. 119, are included in the ‘‘grain, aspirated unaffected by a glyphosate tolerance for Crystal Mall #2, 1921 Jefferson Davis fractions’’ tolerance described above; aspirated grain fractions at 100 ppm and Hwy., Arlington, VA. This docket and by deleting the existing tolerance corn, field, forage at 6.0 ppm. EPA facility is open from 8:30 a.m. to 4 p.m., for animal, feeds, nongrass group, estimates a worst-case dietary burden Monday through Friday, excluding legal except alfalfa at 200 ppm, which is now for livestock animals by assuming an holidays. The docket telephone number included in the established tolerance for animal consumes dietary feeds bearing is (703) 305–5805. animal feed, nongrass, group at 400 the highest permitted residues. In the 2. Electronic access. You may access ppm. case of glyphosate, the dietary feed this Federal Register document Section 408(b)(2)(A)(i) of the FFDCA bearing the highest permitted residue is electronically through the EPA Internet allows EPA to establish a tolerance (the alfalfa hay as the roughage component under the ‘‘Federal Register’’ listings at legal limit for a pesticide chemical of the diet with a tolerance of 400 ppm http://www.epa.gov/fedrgstr/. A residue in or on a food) only if EPA whereas only 6 ppm of glyphosate is frequently updated electronic version of determines that the tolerance is ‘‘safe.’’ permitted in corn forage and 100 ppm 40 CFR part 180 is available at http:// Section 408(b)(2)(A)(ii) of the FFDCA in grain, aspirated fractions.

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Accordingly EPA’s previous assessment grain, aspirated fractions at 100 ppm Pennsylvania Ave., NW., Washington, of exposures and risks will not change. and corn, field, forage at 6.0 ppm. DC 20460–0001. You may also deliver Based on these prior risk assessments, your request to the Office of the Hearing VI. Objections and Hearing Requests EPA concludes that there is a reasonable Clerk in Rm.104, Crystal Mall #2, 1921 certainty that no harm will result to the Under section 408(g) of the FFDCA, as Jefferson Davis Hwy., Arlington, VA. general population, and to infants and amended by the FQPA, any person may The Office of the Hearing Clerk is open children from aggregate exposure to file an objection to any aspect of this from 8 a.m. to 4 p.m., Monday through glyphosate residues. regulation and may also request a Friday, excluding legal holidays. The hearing on those objections. The EPA telephone number for the Office of the IV. Other Considerations procedural regulations which govern the Hearing Clerk is (703) 603–0061. A. Analytical Enforcement Methodology submission of objections and requests 2. Tolerance fee payment. If you file for hearings appear in 40 CFR part 178. an objection or request a hearing, you Adequate enforcement methods are Although the procedures in those must also pay the fee prescribed by 40 available for analysis of residues of regulations require some modification to CFR 180.33(i) or request a waiver of that glyphosate in or on plant and livestock reflect the amendments made to the fee pursuant to 40 CFR 180.33(m). You commodities. These methods include FFDCA by the FQPA, EPA will continue must mail the fee to: EPA Headquarters gas liquid chromatography (GLC) to use those procedures, with Accounting Operations Branch, Office (Method I in Pesticides Analytical appropriate adjustments, until the of Pesticide Programs, P.O. Box Manual (PAM) II; the limit of detection necessary modifications can be made. 360277M, Pittsburgh, PA 15251. Please is 0.05 ppm) and high performance The new section 408(g) of the FFDCA identify the fee submission by labeling liquid chromatography (HPLC) with provides essentially the same process it ‘‘Tolerance Petition Fees.’’ fluorometric detection. Use of the GLC for persons to ‘‘object’’ to a regulation EPA is authorized to waive any fee method is discouraged due to the for an exemption from the requirement requirement ‘‘when in the judgement of lengthiness of the experimental of a tolerance issued by EPA under new the Administrator such a waiver or procedure. The HPLC procedure has section 408(d) of FFDCA, as was refund is equitable and not contrary to undergone successful Agency validation provided in the old sections 408 and the purpose of this subsection.’’ For and was recommended for inclusion in 409 of the FFDCA. However, the period additional information regarding the PAM II. A gas chromatography mass for filing objections is now 60 days, waiver of these fees, you may contact spectrometry (GC/MS) method for rather than 30 days. James Tompkins by phone at (703) 305– 5697, by e-mail at glyphosate in crops has also been A. What Do I Need to Do to File an [email protected], or by mailing a validated by EPA’s Analytical Objection or Request a Hearing? Chemistry Laboratory (ACL). Thus, request for information to Mr. Tompkins adequate analytical methods are You must file your objection or at Registration Division (7505C), Office available for residue data collection and request a hearing on this regulation in of Pesticide Programs, Environmental enforcement of the tolerances of accordance with the instructions Protection Agency, 1200 Pennsylvania glyphosate in/on aspirated grain, provided in this unit and in 40 CFR part Ave., NW., Washington, DC 20460– aspirated fractions and corn, field, 178. To ensure proper receipt by EPA, 0001. forage. The method may be requested you must identify docket ID number If you would like to request a waiver from: Chief, Analytical Chemistry OPP–2003–0155 in the subject line on of the tolerance objection fees, you must Branch, Environmental Science Center, the first page of your submission. All mail your request for such a waiver to: 701 Mapes Rd., Ft. Meade, MD 20755– requests must be in writing, and must be James Hollins, Information Resources 5350; telephone number: (410) 305– mailed or delivered to the Hearing Clerk and Services Division (7502C), Office of 2905; e-mail address: on or before August 18, 2003. Pesticide Programs, Environmental 1. Filing the request. Your objection [email protected]. Protection Agency, 1200 Pennsylvania must specify the specific provisions in Ave., NW., Washington, DC 20460– B. International Residue Limits the regulation that you object to, and the 0001. grounds for the objections (40 CFR 3. Copies for the Docket. In addition Codex and Mexican maximum 178.25). If a hearing is requested, the to filing an objection or hearing request residue limits (MRLs) are established for objections must include a statement of with the Hearing Clerk as described in residues of glyphosate (glifosato) per se the factual issues(s) on which a hearing Unit VI.A., you should also send a copy and Canadian MRLs are established for is requested, the requestor’s contentions of your request to the PIRIB for its combined residues of glyphosate and on such issues, and a summary of any inclusion in the official record that is AMPA in a variety of raw agricultural, evidence relied upon by the objector (40 described in Unit I.B.1. Mail your processed, and animal commodities. CFR 178.27). Information submitted in copies, identified by docket ID number Currently a relevant Codex MRL for connection with an objection or hearing OPP–2003–0155, to: Public Information maize forage is established at 1.0 ppm. request may be claimed confidential by and Records Integrity Branch, No Canadian MRL is established for marking any part or all of that Information Resources and Services aspirated grain fractions or corn forage. information as CBI. Information so Division (7502C), Office of Pesticide The U.S. tolerance corn, field, forage at marked will not be disclosed except in Programs, Environmental Protection 6.0 ppm, cannot be harmonized with the accordance with procedures set forth in Agency, 1200 Pennsylvania Ave., NW., Codex MRL for maize, forage at 1 ppm 40 CFR part 2. A copy of the Washington, DC 20460–0001. In person because the U.S. tolerance is based on information that does not contain CBI or by courier, bring a copy to the higher application rates than those used must be submitted for inclusion in the location of the PIRIB described in Unit in the residue studies previously public record. Information not marked I.B.1. You may also send an electronic considered by Codex. confidential may be disclosed publicly copy of your request via e-mail to: opp- V. Conclusion by EPA without prior notice. [email protected]. Please use an ASCII Mail your written request to: Office of file format and avoid the use of special Therefore, the tolerance is established the Hearing Clerk (1900C), characters and any form of encryption. for residues of glyphosate, in or on Environmental Protection Agency, 1200 Copies of electronic objections and

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hearing requests will also be accepted consensus standards pursuant to section responsibilities between the Federal on disks in WordPerfect 6.1/8.0 or 12(d) of the National Technology Government and Indian tribes.’’ This ASCII file format. Do not include any Transfer and Advancement Act of 1995 rule will not have substantial direct CBI in your electronic copy. You may (NTTAA), Public Law 104–113, section effects on tribal governments, on the also submit an electronic copy of your 12(d) (15 U.S.C. 272 note). Since relationship between the Federal request at many Federal Depository tolerances and exemptions that are Government and Indian tribes, or on the Libraries. established on the basis of a petition distribution of power and B. When Will the Agency Grant a under section 408(d) of the FFDCA, responsibilities between the Federal Request for a Hearing? such as the tolerance in this final rule, Government and Indian tribes, as do not require the issuance of a specified in Executive Order 13175. A request for a hearing will be granted proposed rule, the requirements of the Thus, Executive Order 13175 does not if the Administrator determines that the Regulatory Flexibility Act (RFA) (5 apply to this rule. material submitted shows the following: U.S.C. 601 et seq.) do not apply. In VIII. Congressional Review Act There is a genuine and substantial issue addition, the Agency has determined of fact; there is a reasonable possibility that this action will not have a The Congressional Review Act, 5 that available evidence identified by the substantial direct effect on States, on the U.S.C. 801 et seq., as added by the Small requestor would, if established resolve relationship between the national Business Regulatory Enforcement one or more of such issues in favor of government and the States, or on the Fairness Act of 1996, generally provides the requestor, taking into account distribution of power and that before a rule may take effect, the uncontested claims or facts to the responsibilities among the various agency promulgating the rule must contrary; and resolution of the factual levels of government, as specified in submit a rule report, which includes a issues(s) in the manner sought by the Executive Order 13132, entitled copy of the rule, to each House of the requestor would be adequate to justify Federalism(64 FR 43255, August 10, Congress and to the Comptroller General the action requested (40 CFR 178.32). 1999). Executive Order 13132 requires of the United States. EPA will submit a VII. Statutory and Executive Order EPA to develop an accountable process report containing this rule and other Reviews to ensure ‘‘meaningful and timely input required information to the U.S. Senate, This final rule establishes a tolerance by State and local officials in the the U.S. House of Representatives, and under section 408(d) of the FFDCA in development of regulatory policies that the Comptroller General of the United response to a petition submitted to the have federalism implications.’’ ‘‘Policies States prior to publication of this final Agency. The Office of Management and that have federalism implications’’ is rule in the Federal Register. This final Budget (OMB) has exempted these types defined in the Executive Order to rule is not a ‘‘major rule’’ as defined by of actions from review under Executive include regulations that have 5 U.S.C. 804(2). ‘‘substantial direct effects on the States, Order 12866, entitled Regulatory List of Subjects in 40 CFR Part 180 Planning and Review (58 FR 51735, on the relationship between the national October 4, 1993). Because this rule has government and the States, or on the Environmental protection, been exempted from review under distribution of power and Administrative practice and procedure, Executive Order 12866 due to its lack of responsibilities among the various Agricultural commodities, Pesticides significance, this rule is not subject to levels of government.’’ This final rule and pests, Reporting and recordkeeping Executive Order 13211, Actions directly regulates growers, food requirements. Concerning Regulations That processors, food handlers and food Dated: June 2, 2003. retailers, not States. This action does not Significantly Affect Energy Supply, Debra Edwards, Distribution, or Use (66 FR 28355, May alter the relationships or distribution of power and responsibilities established Director, Registration Division, Office of 22, 2001). This final rule does not Pesticide Programs. contain any information collections by Congress in the preemption subject to OMB approval under the provisions of section 408(n)(4) of the ■ Therefore, 40 CFR chapter I is Paperwork Reduction Act (PRA), 44 FFDCA. For these same reasons, the amended as follows: U.S.C. 3501 et seq., or impose any Agency has determined that this rule enforceable duty or contain any does not have any ‘‘tribal implications’’ PART 180—[AMENDED] unfunded mandate as described under as described in Executive Order 13175, ■ entitled Consultation and Coordination 1. The authority citation for part 180 Title II of the Unfunded Mandates continues to read as follows: Reform Act of 1995 (UMRA) (Public with Indian Tribal Governments (65 FR Law 104–4). Nor does it require any 67249, November 6, 2000). Executive Authority: 21 U.S.C. 321(q), 346(a) and special considerations under Executive Order 13175, requires EPA to develop 371. Order 12898, entitled Federal Actions to an accountable process to ensure ■ 2. Section 180.364 is amended by Address Environmental Justice in ‘‘meaningful and timely input by tribal removing the entire entries for ‘‘Animal Minority Populations and Low-Income officials in the development of feed, nongrass, group, except alfalfa,’’ Populations (59 FR 7629, February 16, regulatory policies that have tribal ‘‘Aspirated grain fractions,’’ and 1994); or OMB review or any Agency implications.’’ ‘‘Policies that have tribal ‘‘Soybean, aspirated grain fractions’’ and action under Executive Order 13045, implications’’ is defined in the by alphabetically adding the following entitled Protection of Children from Executive Order to include regulations commodities to the table in paragraph (a) Environmental Health Risks and Safety that have ‘‘substantial direct effects on to read as follows. Risks (62 FR 19885, April 23, 1997). one or more Indian tribes, on the This action does not involve any relationship between the Federal § 180.364 Glyphosate; tolerances for technical standards that would require Government and the Indian tribes, or on residues. Agency consideration of voluntary the distribution of power and (a) * * *

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Commodity Parts per million

***** Corn, field, forage ...... 6.0 ***** Grain, aspirated fractions ...... 100.0 *****

* * * * * I. General Information holidays. The docket telephone number [FR Doc. 03–15128 Filed 6–17–03; 8:45 am] is (703) 305–5805. A. Does this Action Apply to Me? 2. Electronic access. You may access BILLING CODE 6560–50–S You may be potentially affected by this Federal Register document this action if you are an agricultural electronically through the EPA Internet ENVIRONMENTAL PROTECTION producer, food manufacturer or under the ‘‘Federal Register’’ listings at AGENCY pesticide manufacturer. Potentially http://www.epa.gov/fedrgstr/. A affected entities may include, but are frequently updated electronic version of 40 CFR Part 180 not limited to: 40 CFR part 180 is available at http:// • Crop production/Agriculture www.access.gpo.gov/nara/cfr/ _ _ _ [OPP–2003–0113; FRL–7301–1] (NAICS 111) cfrhtml 00/Title 40/40cfr180 00.html, • Animal production (NAICS 112) a beta site currently under development. Bacillus Pumilus Strain QST2808; • Food manufacturing (NAICS 311) To access the OPPTS Harmonized Temporary Exemption From the Guidelines referenced in this document, • Pesticide manufacturing (NAICS Requirement of a Tolerance go directly to the guidelines at http:// 32532) www.epa.gov/opptsfrs/home/ AGENCY: Environmental Protection This listing is not intended to be guidelin.htm. Agency (EPA). exhaustive, but rather provides a guide An electronic version of the public ACTION: Final rule. for readers regarding entities likely to be docket is available through EPA’s affected by this action. Other types of electronic public docket and comment SUMMARY: This regulation establishes a entities not listed in this unit could also system, EPA Dockets. You may use EPA temporary exemption from the be affected. The North American Dockets at http://www.epa.gov/edocket/ requirement of a tolerance for residues Industrial Classification System to submit or view public comments, of the Bacillus pumilus strain QST2808 (NAICS) codes have been provided to access the index listing of the contents in or on all agricultural commodities assist you and others in determining of the official public docket, and to when applied/used in accordance with whether this action might apply to access those documents in the public label directions. AgraQuest, Inc. certain entities. To determine whether docket that are available electronically. submitted a petition to EPA under the you or your business may be affected by Although not all docket materials may Federal Food, Drug, and Cosmetic Act this action, you should carefully be available electronically, you may still (FFDCA), as amended by the Food examine the applicability provisions. If access any of the publicly available Quality Protection Act of 1996 (FQPA), you have any questions regarding the docket materials through the docket requesting the temporary tolerance applicability of this action to a facility identified in Unit I.B.1. Once in exemption. This regulation eliminates particular entity, consult the person the system, select ‘‘search,’’ then key in the need to establish a maximum listed under FOR FURTHER INFORMATION the appropriate docket ID number. permissible level for residues of Bacillus CONTACT. pumilus strain QST2808. The temporary II. Background and Statutory Findings B. How Can I Get Copies of this tolerance exemption will expire on June Document and Other Related In the Federal Register of May 3, 2001 30, 2006. Information? (66 FR 22225) (FRL–6773–9), EPA DATES: This regulation is effective June issued a notice pursuant to section 408 18, 2003. Objections and requests for 1. Docket. EPA has established an of the FFDCA, 21 U.S.C. 346a, as hearings, identified by docket ID official public docket for this action amended by FQPA (Public Law 104– number OPP–2003–0113, must be under docket identification (ID) number 170), announcing the filing of a received by EPA on or before August 18, OPP–2003–0113. The official public pesticide tolerance petition (PP 2003. docket consists of the documents 1G6240), submitted by AgraQuest, Inc., ADDRESSES: Written objections and specifically referenced in this action, 1530 Drew Avenue, Davis, CA 95616. hearing requests may be submitted by any public comments received, and This notice included a summary of the mail or through hand delivery/courier. other information related to this action. petition prepared by the petitioner Follow the detailed instructions as Although a part of the official docket, AgraQuest, Inc. There were no provided in Unit VIII. of the the public docket does not include comments received in response to the SUPPLEMENTARY INFORMATION. Confidential Business Information (CBI) notice of filing. or other information whose disclosure is The petition requested that 40 CFR FOR FURTHER INFORMATION CONTACT: restricted by statute. The official public part 180 be amended by establishing a Susanne Cerrelli, Biopesticides and docket is the collection of materials that temporary exemption from the Pollution Prevention Division (7511C), is available for public viewing at the requirement of a tolerance for residues Environmental Protection Agency, 1200 Public Information and Records of Bacillus pumilus strain QST2808. Pennsylvania Ave., NW., Washington, Integrity Branch (PIRIB), Rm. 119, Section 408(c)(2)(A)(i) of the FFDCA DC 20460–0001; telephone number: Crystal Mall #2, 1921 Jefferson Davis allows EPA to establish an exemption (703) 308–8077 ; e-mail address: Hwy., Arlington, VA. This docket from the requirement for a tolerance (the [email protected]. facility is open from 8:30 a.m. to 4 p.m., legal limit for a pesticide chemical SUPPLEMENTARY INFORMATION: Monday through Friday, excluding legal residue in or on a food) only if EPA

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determines that the exemption is ‘‘safe.’’ requirement of a tolerance are Classification: Acceptable. (BPPD Section 408(c)(2)(A)(ii) of the FFDCA summarized below. Review - 1/7/02). defines ‘‘safe’’ to mean that ‘‘there is a 1. Acute oral toxicity and 6. Acute Inhalation toxicity (OPPTS reasonable certainty that no harm will pathogenicity rats (OPPTS Harmonized Harmonized Guideline 870.1300). result from aggregate exposure to the Guideline 885.3050; Master Record Results of the acute pulmonary toxicity/ pesticide chemical residue, including Identification Number (MRID) 451366– pathogenicity (MRID 451366–06) all anticipated dietary exposures and all 04). Fifteen male and fifteen female rats performed with Bacillus pumilus strain other exposures for which there is each were administered 4.1 x 109 cfu of QST2808 Technical indicate that it is reliable information.’’ This includes Bacillus pumilus strain QST2808 not toxic, infective, and/or pathogenic exposure through drinking water and in Technical and observed for 14 days. to rats when dosed at 1.6 x 108 cfu/ residential settings, but does not include Based on the data, Bacillus pumilus animal. For the purposes of this specific occupational exposure. Section strain QST2808 does not appear to be action, the Agency has determined that 408(b)(2)(C) of the FFDCA requires EPA toxic, infective, and/or pathogenic in the acute pulmonary toxicity/ to give special consideration to rats, when dosed at 4.1 x 109 cfu/ pathogenicity data are adequate to exposure of infants and children to the animal. Classification: Acceptable; support and/or fulfill this particular pesticide chemical residue in Toxicity Category IV. (C. Etsitty’s data requirement. establishing a tolerance and to ‘‘ensure Memorandum to John L. Kough, dated 7. Primary dermal irritation (OPPTS that there is a reasonable certainty that 1/7/02 (hereinafter referred to as ‘‘BPPD Harmonized Guideline 870.2500; MRID no harm will result to infants and Review - 1/7/02’’)). 452679–02). Each of three male adult children from aggregate exposure to the 2. Acute dermal toxicity (OPPTS rabbits were treated dermally with 0.5 pesticide chemical residue. . . .’’ Harmonized Guideline 885.3100; MRID mL QST2808 Technical for 4 hours and Additionally, section 408(b)(2)(D) of the 451366–05). Five male and five female observed for the following 72 hours. FFDCA requires that the Agency rabbits were dermally treated with 2g/kg Based on the data, no abnormal clinical consider ‘‘available information body weight Bacillus pumilus strain signs were noted. Approximately 60 concerning the cumulative effects of a QST2808 Technical for 24 hours and minutes after patch removal, very slight particular pesticide’s residues’’ and observed for the following 14 days. The erythema was noted on one of the three ‘‘other substances that have a common acute lethal dose (LD50) is greater than rabbits with resolution by 24 hours. mechanism of toxicity.’’ 2,000 mg/kg. Classification: Acceptable; When dosed with QST2808 Technical at EPA performs a number of analyses to Toxicity Category III. (BPPD Review - 1/ 0.5 mL/animal, QST2808 Technical was determine the risks from aggregate 7/02). essentially non-irritating. Classification: exposure to pesticide residues. First, 3. Primary eye irritation (OPPTS Acceptable; Toxicity Category IV. (BPPD EPA determines the toxicity of Harmonized Guideline 870.2400; MRID Review - 1/7/02). pesticides. Second, EPA examines 452679–01). Three male rabbits each 8. Hypersensitivity incidents (OPPTS exposure to the pesticide through food, were administered 0.1 mL of QST2808 Harmonized Guideline 885.3400). The drinking water, and through other Technical in the everted lower lid of registrant reported (November 1, 2000) exposures that occur as a result of one eye and then observed for 72 hours. no incidents to date. pesticide use in residential settings. Based on the data, QST2808 Technical 9. Immune response. There is no showed minimal effects to the eye. III. Toxicological Profile information to suggest that Bacillus Classification: Acceptable; Toxicity pumilus strain QST2808 has an effect on Consistent with section 408(b)(2)(D) Category IV. (BPPD Review - 1/7/02). the immune system. The submitted of the FFDCA, EPA has reviewed the 4. Acute injection toxicity/ toxicity/pathogenicity studies in rodents available scientific data and other pathogenicity (OPPTS Harmonized indicated that following several routes relevant information in support of this Guideline 885.3200; MRID 451366–07). of exposure, the immune system is still action and considered its validity, Eighteen male and eighteen female rats intact and able to process and clear the completeness and reliability and the each were dosed at 1.6 x 108 cfu Bacillus active ingredient (MRID 451366–04; relationship of this information to pumilus strain QST2808 Technical 451366–06, and 451366–07). human risk. EPA has also considered intravenously and monitored over a Based on the data generated in available information concerning the period of 28 days. A gross necropsy was accordance with the Tier I data variability of the sensitivities of major performed on all rats. Based on the data, requirements set forth in 40 CFR identifiable subgroups of consumers, the test organism was not toxic, § 158.740(c), the Tier II and Tier III data including infants and children. infective, or pathogenic to rats. requirements were not triggered and, Bacillus pumilus is a ubiquitous and Classification: Acceptable. (BPPD therefore, not required in connection naturally occurring bacteria found in Review - 1/7/02). with this action. In addition, because soil. The results of the acute toxicology 5. Acute pulmonary toxicity/ the Tier II and Tier III data requirements and pathogenicity studies required of pathogenicity (OPPTS Harmonized were not required, the residue data the petitioner under section 408(d)(2)(A) Guideline 885.3150; MRID 451366–06). requirements set forth in 40 CFR of the FFDCA in support of its petition Eighteen male and eighteen female rats § 158.740(b) also were not required. for a temporary exemption from the each were administered 1.6 x 108 cfu IV. Aggregate Exposures requirement of a tolerance for Bacillus Bacillus pumilus strain QST2808 pumilus strain QST2808 indicate Technical by a single intratracheal In examining aggregate exposure, negligible to no mammalian toxicity. In dosage and monitored over a period of section 408 of the FFDCA directs EPA addition, no pathogenicity was observed 35 days for clinical signs of toxicity. to consider available information in any of the tests conducted with the Necropsy studies showed no significant concerning exposures from the pesticide Bacillus pumilus strain QST2808 signs of abnormalities due to the test residue in food and all other non- Technical product. organism. Based on the data, Bacillus occupational exposures, including The toxicology and pathogenicity data pumilus strain QST2808 was not toxic, drinking water from ground water or generated by AgraQuest, Inc in support infective, and/or pathogenic to rats surface water and exposure through of this temporary exemption from the when dosed at 1.6 x 108 cfu/animal. pesticide use in gardens, lawns, or

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buildings (residential and other indoor proposed product would be negligible. requirement of a tolerance should be uses). Furthermore, and as demonstrated in considered safe and pose no significant Unit III of this action, the organism is of risk. A. Dietary Exposure low dermal toxicity, the acute lethal FFDCA section 408(b)(2)(C) provides Humans and animals are commonly dose (LD50) is greater than 2,000 mg/kg, that EPA shall apply an additional exposed to Bacillus pumilus, a and the QST2808 Technical was tenfold margin of exposure (safety) for ubiquitous microorganism that inhabits essentially non-irritating (Toxicity infants and children in the case of soil. No toxicological endpoints were Category IV). Accordingly, the risks threshold effects to account for prenatal identified for Bacillus pumilus strain anticipated for this route of exposure are and postnatal toxicity and the QST2808. The low toxicity and non- considered minimal. completeness of the data base on pathogenicity/infectivity of Bacillus 2. Inhalation exposure. The potential toxicity and exposure, unless EPA pumilus strain QST2808 is for inhalation exposure to Bacillus determines that a different margin of demonstrated by the data summarized pumilus strain QST2808 pesticide exposure (safety) will be safe for infants in Unit III of this action. residues for the general population, and children. Margins of exposure 1. Food. While the proposed use including infants and children is (safety) are incorporated into EPA risk pattern may result in dietary exposure unlikely because potential use sites are assessments either directly through the with possible residues in or on agricultural and horticultural. However, use of a margin of exposure analysis or agricultural commodities, negligible to since Bacillus pumilus is a natural by using uncertainty (safety) factors in no risk is expected for the general occurring bacteria in soil, there is a great calculating a dose level that poses no population, including infants and likelihood of prior exposure for most, if appreciable risk to humans. Due to the children, or animals because Bacillus not all individuals. Accordingly, the ubiquitous nature of Bacillus pumilus, pumilus strain QST2808 technical increase in exposure due to this residues of this microbial pesticide in or demonstrated no pathogenicity or oral proposed product would be negligible. on agricultural commodities are not toxicity at the maximum doses tested, as Furthermore, and as demonstrated in expected to significantly increase noted above in (Unit III). Unit III of this action, the acute exposure to the U.S. population, 2. Drinking water exposure. Most pulmonary toxicity/pathogenicity including infants and children. Here, importantly, there is no evidence of testing performed on the technical EPA concludes that the toxicity and adverse effects from oral, dermal, or formulation did not demonstrate exposure data are sufficiently complete inhalation exposure to this microbial pathogenicity or toxicity of Bacillus to adequately address the potential for agent. (See ‘‘Unit III. Toxicological pumilus strain QST2808. (See Unit III additional sensitivity of infants and Profile’’ above.) In addition, the above.) Accordingly, the risks children to residues of Bacillus pumilus potential for transfer of Bacillus pumilus anticipated for this route of exposure are strain QST2808 and that there is a strain QST2808 to surface or ground considered minimal. reasonable certainty that no harm will water during run-off associated with V. Cumulative Effects result to infants and children from intended use applications is considered aggregate exposure to Bacillus pumilus The Agency has considered the minimal to non-existent, due in part to strain QST2808 residues. its percolation through and resulting potential for cumulative effects of capture in soil. Accordingly, the use of Bacillus pumilus strain QST2808 and VII. Other Considerations other substances in relation to a this microbial pest control agent on A. Endocrine Disruptors terrestrial plants is not anticipated to common mechanism of toxicity. These negatively impact the quality of considerations include the possible EPA is required under section 408(p) drinking water. cumulative effects of such residues on of the FFDCA, as amended by FQPA, to infants and children. Bacillus pumilus develop a screening program to B. Other Non-Occupational Exposure strain QST2808 is practically non-toxic determine whether certain substances Based on the proposed use patterns, to mammals. Because no mechanism of (including all pesticide active and other the potential of non-dietary exposures to pathogenicity or toxicity in mammals ingredients) ‘‘may have an effect in Bacillus pumilus strain QST2808 has been identified for this organism humans that is similar to an effect pesticide residues for the general (see Unit III above), no cumulative produced by a naturally-occurring population, including infants and effects from the residues of this product estrogen, or other such endocrine effects children, is unlikely. Accordingly, the with other related microbial pesticides as the Administrator may designate.’’ Agency believes that the potential is anticipated. Following the recommendations of its aggregate non-occupational exposure, Endocrine Disruptor Screening and derived from dermal and inhalation VI. Determination of Safety for U.S. Testing Advisory Committee (EDSTAC), exposure through the application of Population, Infants and Children EPA determined that there is no Bacillus pumilus strain QST2808, There is a reasonable certainty that no scientific basis for including, as part of should fall well below the currently harm to the U.S. population, including the screening program, the androgen tested microbial safety levels. infants and children, will result from and thyroid hormone systems in 1. Dermal exposure. The potential for aggregate exposure to residues of addition to the estrogen hormone dermal exposure to Bacillus pumilus Bacillus pumilus strain QST2808 due to system. EPA also adopted EDSTAC’s strain QST2808 pesticide residues for its use as a microbial pest control agent. recommendation that the program the general population, including This includes all anticipated dietary include evaluations of potential effects infants and children, is unlikely because exposures and all other exposures for in wildlife. For pesticide chemicals, potential use sites are agricultural and which there is reliable information. As EPA will use FIFRA and, to the extent horticultural. However, since Bacillus discussed previously, Bacillus pumilus that effects in wildlife may help pumilus strain QST2808 is a naturally strain QST2808 is not pathogenic or determine whether a substance may occurring bacteria in soil, there is a great infective and is practically non-toxic to have an effect in humans, FFDCA likelihood of prior exposure for most, if mammals. (See Unit III above.) authority to require wildlife evaluations. not all individuals. Accordingly, the Accordingly, exempting Bacillus As the science develops and resources increase in exposure due to this pumilus strain QST 2808 from the allow, screening of additional hormone

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systems may be added to the Endocrine A. What Do I Need to Do to File an James Tompkins by phone at (703) 305– Disruptor Screening Program (EDSP). Objection or Request a Hearing? 5697, by e-mail at When the appropriate screening and/or You must file your objection or [email protected], or by mailing a testing protocols being considered request a hearing on this regulation in request for information to Mr. Tompkins under the Agency’s EDSP have been accordance with the instructions at Registration Division (7505C), Office developed, Bacillus pumilus strain provided in this unit and in 40 CFR part of Pesticide Programs, Environmental QST2808 may be subjected to additional 178. To ensure proper receipt by EPA, Protection Agency, 1200 Pennsylvania screening and/or testing to better you must identify docket ID number Ave., NW., Washington, DC 20460– characterize effects related to endocrine OPP–2003–0113 in the subject line on 0001. disruption. the first page of your submission. All If you would like to request a waiver To date, the Agency has no objections and requests for hearings of the tolerance objection fees, you must information to suggest that Bacillus must be in writing, and must be mailed mail your request for such a waiver to: pumilus strain QST2808 has an effect on or delivered to the Hearing Clerk on or James Hollins, Information Resources the endocrine systems. Moreover, as is before August 18, 2003. and Services Division (7502C), Office of 1. Filing the request. Your objection expected from a non-pathogenic Pesticide Programs, Environmental must specify the specific provisions in microorganism that is practically non- Protection Agency, 1200 Pennsylvania toxic to mammals, the submitted the regulation that you object to, and the grounds for the objections (40 CFR Ave., NW., Washington, DC 20460– toxicity/pathogenicity studies in rodents 0001. indicated that following several routes 178.25). If a hearing is requested, the of exposure, the immune system is still objections must include a statement of 3. Copies for the Docket. In addition intact and able to process and clear the the factual issues(s) on which a hearing to filing an objection or hearing request active ingredient. (BPPD Review - 1/7/ is requested, the requestor’s contentions with the Hearing Clerk as described in 02). on such issues, and a summary of any Unit VIII.A., you should also send a evidence relied upon by the objector (40 copy of your request to the PIRIB for its B. Analytical Method CFR 178.27). Information submitted in inclusion in the official record that is connection with an objection or hearing described in Unit I.B.1. Mail your The Agency proposes to establish an request may be claimed confidential by copies, identified by docket ID number exemption from the requirement of a marking any part or all of that OPP–2003–0113, to: Public Information tolerance without any numerical information as CBI. Information so and Records Integrity Branch, limitation for the reasons stated above, marked will not be disclosed except in Information Resources and Services including Bacillus pumilus strain accordance with procedures set forth in QST2808’s lack of mammalian toxicity. Division (7502C), Office of Pesticide 40 CFR part 2. A copy of the Programs, Environmental Protection For the same reasons, the Agency has information that does not contain CBI Agency, 1200 Pennsylvania Ave., NW., concluded that an analytical method is must be submitted for inclusion in the Washington, DC 20460–0001. In person not required for enforcement purpose public record. Information not marked for Bacillus pumilus strain QST2808. confidential may be disclosed publicly or by courier, bring a copy to the by EPA without prior notice. location of the PIRIB described in Unit C. Codex Maximum Residue Level Mail your written request to: Office of I.B.1. You may also send an electronic copy of your request via e-mail to: opp- There is no Codex Alimentarius the Hearing Clerk (1900C), [email protected]. Please use an ASCII Commission Maximum Residue Level Environmental Protection Agency, 1200 file format and avoid the use of special for Bacillus pumilus strain QST2808. Pennsylvania Ave., NW., Washington, DC 20460–0001. You may also deliver characters and any form of encryption. VIII. Objections and Hearing Requests your request to the Office of the Hearing Copies of electronic objections and Clerk in Rm.104, Crystal Mall #2, 1921 hearing requests will also be accepted Under section 408(g) of the FFDCA, as Jefferson Davis Hwy., Arlington, VA. on disks in WordPerfect 6.1/8.0 or amended by the FQPA, any person may The Office of the Hearing Clerk is open ASCII file format. Do not include any file an objection to any aspect of this from 8 a.m. to 4 p.m., Monday through CBI in your electronic copy. You may regulation and may also request a Friday, excluding legal holidays. The also submit an electronic copy of your hearing on those objections. The EPA telephone number for the Office of the request at many Federal Depository procedural regulations which govern the Hearing Clerk is (703) 603–0061. Libraries. submission of objections and requests 2. Tolerance fee payment. If you file for hearings appear in 40 CFR part 178. an objection or request a hearing, you B. When Will the Agency Grant a Although the procedures in those must also pay the fee prescribed by 40 Request for a Hearing? regulations require some modification to CFR 180.33(i) or request a waiver of that A request for a hearing will be granted reflect the amendments made to the fee pursuant to 40 CFR 180.33(m). You FFDCA by the FQPA, EPA will continue must mail the fee to: EPA Headquarters if the Administrator determines that the to use those procedures, with Accounting Operations Branch, Office material submitted shows the following: appropriate adjustments, until the of Pesticide Programs, P.O. Box There is a genuine and substantial issue necessary modifications can be made. 360277M, Pittsburgh, PA 15251. Please of fact; there is a reasonable possibility The new section 408(g) of the FFDCA identify the fee submission by labeling that available evidence identified by the provides essentially the same process it ‘‘Tolerance Petition Fees.’’ requestor would, if established resolve for persons to ‘‘object’’ to a regulation EPA is authorized to waive any fee one or more of such issues in favor of for an exemption from the requirement requirement ‘‘when in the judgement of the requestor, taking into account of a tolerance issued by EPA under new the Administrator such a waiver or uncontested claims or facts to the section 408(d), as was provided in the refund is equitable and not contrary to contrary; and resolution of the factual old sections 408 and 409 of the FFDCA. the purpose of this subsection.’’ For issues(s) in the manner sought by the However, the period for filing objections additional information regarding the requestor would be adequate to justify is now 60 days, rather than 30 days. waiver of these fees, you may contact the action requested (40 CFR 178.32).

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IX. Statutory and Executive Order to ensure ‘‘meaningful and timely input rule in the Federal Register. This final Reviews by State and local officials in the rule is not a ‘‘major rule ’’ as defined by This final rule establishes a temporary development of regulatory policies that 5 U.S.C. 804(2). have federalism implications.’’ ‘‘Policies exemption from the tolerance List of Subjects in 40 CFR Part 180 requirement for Bacillus pumilus strain that have federalism implications’’ is Environmental protection, QST2808 under section 408(d) of the defined in the Executive Order to Administrative practice and procedure, FFDCA in response to a petition include regulations that have Agricultural commodities, Pesticides submitted to the Agency. The Office of ‘‘substantial direct effects on the States, and pests, Reporting and recordkeeping Management and Budget (OMB) has on the relationship between the national exempted these types of actions from government and the States, or on the requirements. review under Executive Order 12866, distribution of power and Dated: June 3, 2003. entitled Regulatory Planning and responsibilities among the various James Jones, Review (58 FR 51735, October 4, 1993). levels of government.’’ This final rule Director, Office of Pesticide Programs. directly regulates growers, food Because this rule has been exempted ■ processors, food handlers and food Therefore, 40 CFR chapter I is from review under Executive Order amended as follows: 12866 due to its lack of significance, retailers, not States. This action does not this rule is not subject to Executive alter the relationships or distribution of PART 180—[AMENDED] Order 13211, Actions Concerning power and responsibilities established ■ Regulations That Significantly Affect by Congress in the preemption 1. The authority citation for part 180 Energy Supply, Distribution, or Use (66 provisions of section 408(n)(4) of the continues to read as follows: FR 28355, May 22, 2001). This final rule FFDCA. For these same reasons, the Authority: 21 U.S.C. 321(q), 346(a) and does not contain any information Agency has determined that this rule 371. collections subject to OMB approval does not have any ‘‘tribal implications’’ ■ 2. Section 180.1226 is added to subpart under the Paperwork Reduction Act as described in Executive Order 13175, D to read as follows: (PRA), 44 U.S.C. 3501 et seq., or impose entitled Consultation and Coordination with Indian Tribal Governments (65 FR § 180.1226 Bacillus pumilus strain any enforceable duty or contain any 67249, November 6, 2000). Executive QST2808; temporary exemption from the unfunded mandate as described under Order 13175, requires EPA to develop requirement of a tolerance. Title II of the Unfunded Mandates an accountable process to ensure A temporary exemption from the Reform Act of 1995 (UMRA) (Public ‘‘meaningful and timely input by tribal requirement of a tolerance is established Law 104–4). Nor does it require any officials in the development of for residues of the microbial pesticide special considerations under Executive regulatory policies that have tribal Bacillus pumilus strain QST2808 when Order 12898, entitled Federal Actions to implications.’’ ‘‘Policies that have tribal used in or on all agricultural Address Environmental Justice in implications’’ is defined in the commodities when applied/used in Minority Populations and Low-Income Executive Order to include regulations accordance with label directions. Populations (59 FR 7629, February 16, that have ‘‘substantial direct effects on [FR Doc. 03–15129 Filed 6–17 –03; 8:45 am] 1994); or OMB review or any Agency one or more Indian tribes, on the BILLING CODE 6560–50–S action under Executive Order 13045, relationship between the Federal entitled Protection of Children from Government and the Indian tribes, or on Environmental Health Risks and Safety the distribution of power and Risks (62 FR 19885, April 23, 1997). ENVIRONMENTAL PROTECTION responsibilities between the Federal AGENCY This action does not involve any Government and Indian tribes.’’ This technical standards that would require rule will not have substantial direct 40 CFR Part 180 Agency consideration of voluntary effects on tribal governments, on the consensus standards pursuant to section relationship between the Federal [OPP–2003–0196; FRL–7311–2] 12(d) of the National Technology Government and Indian tribes, or on the Azoxystrobin; Pesticide Tolerance Transfer and Advancement Act of 1995 distribution of power and (NTTAA), Public Law 104–113, section responsibilities between the Federal AGENCY: Environmental Protection 12(d) (15 U.S.C. 272 note). Since government and Indian tribes, as Agency (EPA). tolerances and exemptions that are specified in Executive Order 13175. ACTION: Final rule. established on the basis of a petition Thus, Executive Order 13175 does not under section 408(d) of the FFDCA, apply to this rule. SUMMARY: This regulation establishes such as the exemption in this final rule, tolerances for combined residues of do not require the issuance of a X. Congressional Review Act azoxystrobin, methyl (E)-2-[[6-(2- proposed rule, the requirements of the The Congressional Review Act, 5 cyanophenoxy)-4-pyrimidinyl]oxy]-∝- Regulatory Flexibility Act (RFA) (5 U.S.C. 801 et seq., as added by the Small (methoxymethylene)-benzeneacetate, U.S.C. 601 et seq.) do not apply. In Business Regulatory Enforcement and its Z isomer, methyl (Z)-2-[[6-(2- addition, the Agency has determined Fairness Act of 1996, generally provides cyanophenoxy)-4-pyrimidinyl]oxy]- that this action will not have a that before a rule may take effect, the ∝(methoxymethylene)-benzeneacetate, substantial direct effect on States, on the agency promulgating the rule must in or on artichoke, globe; asparagus; relationship between the national submit a rule report, which includes a brassica, head and stem, subgroup 5A; government and the States, or on the copy of the rule, to each House of the herb subgroup 19A, (dried) except distribution of power and Congress and to the Comptroller General chive; and herb subgroup 19A, (fresh) responsibilities among the various of the United States. EPA will submit a except chive. Interregional Research levels of government, as specified in report containing this rule and other Project Number 4 (IR-4) requested these Executive Order 13132, entitled required information to the U.S. Senate, tolerances under the Federal Food, Federalism (64 FR 43255, August 10, the U.S. House of Representatives, and Drug, and Cosmetic Act (FFDCA), as 1999). Executive Order 13132 requires the Comptroller General of the United amended by the Food Quality Protection EPA to develop an accountable process States prior to publication of this final Act of 1996 (FQPA).

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DATES: This regulation is effective June for public viewing at the Public subgroup 19A, fresh, except chive at 50 18, 2003. Objections and requests for Information and Records Integrity ppm. hearings, identified by docket Branch (PIRIB), Rm. 119, Crystal Mall Section 408(b)(2)(A)(i) of the FFDCA identification (ID) number OPP–2003– #2, 1921 Jefferson Davis Hwy., allows EPA to establish a tolerance (the 0196, must be received on or before Arlington, VA. This docket facility is legal limit for a pesticide chemical August 18, 2003. open from 8:30 a.m. to 4 p.m., Monday residue in or on a food) only if EPA ADDRESSES: Written objections and through Friday, excluding legal determines that the tolerance is ‘‘safe.’’ hearing requests may be submitted holidays. The docket telephone number Section 408(b)(2)(A)(ii) of the FFDCA electronically, by mail, or through hand is (703) 305–5805. defines ‘‘safe’’ to mean that ‘‘there is a delivery/courier. Follow the detailed 2. Electronic access. You may access reasonable certainty that no harm will instructions as provided in Unit VI. of this Federal Register document result from aggregate exposure to the the SUPPLEMENTARY INFORMATION. electronically through the EPA Internet pesticide chemical residue, including FOR FURTHER INFORMATION CONTACT: under the ‘‘Federal Register’’ listings at all anticipated dietary exposures and all Shaja R. Brothers, Registration Division http://www.epa.gov/fedrgstr/. A other exposures for which there is (7505C), Office of Pesticide Programs, frequently updated electronic version of reliable information.’’ This includes Environmental Protection Agency, 1200 40 CFR part 180 is available at http:// exposure through drinking water and in www.access.gpo.gov/nara/cfr/ residential settings, but does not include Pennsylvania Ave., NW.,Washington, __ __ DC 20460–0001; telephone number: cfrhtml 00/Title 40/ occupational exposure. Section 40cfr180_00.html, a beta site currently 408(b)(2)(C) of the FFDCA requires EPA (703) 308–3194; e-mail address: under development. To access the to give special consideration to [email protected]. OPPTS Harmonized Guidelines exposure of infants and children to the SUPPLEMENTARY INFORMATION: referenced in this document, go directly pesticide chemical residue in I. General Information to the guidelines at http://www.epa.gov/ establishing a tolerance and to ‘‘ensure opptsfrs/home/guidelin.htm. that there is a reasonable certainty that A. Does this Action Apply to Me? An electronic version of the public no harm will result to infants and You may be potentially affected by docket is available through EPA’s children from aggregate exposure to the this action if you are an agricultural electronic public docket and comment pesticide chemical residue....’’ producer, food manufacturer, and system, EPA Dockets. You may use EPA EPA performs a number of analyses to pesticide manufacturer. Potentially Dockets at http://www.epa.gov/edocket/ determine the risks from aggregate affected entities may include, but are to submit or view public comments, exposure to pesticide residues. For not limited to: access the index listing of the contents further discussion of the regulatory • Crop Production (NAICS 111) of the official public docket, and to requirements of section 408 of the • Animal Production (NAICS 112) access those documents in the public FFDCA and a complete description of • Food manufacturing (NAICS 311) docket that are available electronically. the risk assessment process, see the final • Pesticide manufacturing (NAICS Although not all docket materials may rule on Bifenthrin Pesticide Tolerances 32532) be available electronically, you may still (62 FR 62961, November 26, 1997) This listing is not intended to be access any of the publicly available (FRL–5754–7). exhaustive, but rather provides a guide docket materials through the docket for readers regarding entities likely to be facility identified in Unit I.B.1. Once in III. Aggregate Risk Assessment and affected by this action. Other types of the system, select ‘‘search,’’ then key in Determination of Safety entities not listed in this unit could also the appropriate docket ID number. Consistent with section 408(b)(2)(D) be affected. The North American of the FFDCA, EPA has reviewed the Industrial Classification System II. Background and Statutory Findings available scientific data and other (NAICS) codes have been provided to In the Federal Register of March 26, relevant information in support of this assist you and others in determining 2003 (68 FR 14622) (FRL–7299–3), EPA action. EPA has sufficient data to assess whether this action might apply to issued a notice pursuant to section 408 the hazards of and to make a certain entities. If you have any of FFDCA, 21 U.S.C. 346a, as amended determination on aggregate exposure, questions regarding the applicability of by FQPA (Public Law 104–170), consistent with section 408(b)(2) of the this action to a particular entity, consult announcing the filing of pesticide FFDCA, for tolerances for combined the person listed under FOR FURTHER petitions (PP 2E6375, 2E6488, 2E6489, residues of azoxystrobin on artichoke, INFORMATION CONTACT. and 2E6495) by IR-4, 681 U.S. Highway globe at 4.0 ppm; asparagus at 0.04 ppm; #1 South, North Brunswick, NJ 08902– brassica, head and stem, subgroup 5A at B. How Can I Get Copies of this 3390. That notice included a summary 3.0 ppm; herb subgroup 19A, dried, Document and Other Related of the petitions prepared by Syngenta, except chive at 260 ppm; and herb Information? the registrant. subgroup 19A, fresh, except chive at 50 1. Docket. EPA has established an The petitions requested that 40 CFR ppm. EPA’s assessment of exposures official public docket for this action 180.507 be amended by establishing and risks associated with establishing under docket ID number OPP–2003– tolerances for combined residues of the the tolerances follow. 0196. The official public docket consists fungicide azoxystrobin, methyl (E)-2-[[6- of the documents specifically referenced (2-cyanophenoxy)-4-pyrimidinyl]oxy]- A. Toxicological Profile in this action, any public comments ∝-(methoxymethylene) benzeneacetate EPA has evaluated the available received, and other information related and its Z isomer methyl (Z)-2-[[6-(2- toxicity data and considered its validity, to this action. Although a part of the cyanophenoxy)-4-pyrimidinyl]oxy]-∝- completeness, and reliability as well as official docket, the public docket does (methoxymethylene) benzeneacetate, in the relationship of the results of the not include Confidential Business or on artichoke, globe at 4.0 parts per studies to human risk. EPA has also Information (CBI) or other information million (ppm); asparagus at 0.02 ppm; considered available information whose disclosure is restricted by statute. brassica, head and stem, subgroup 5A at concerning the variability of the The official public docket is the 3.0 ppm; herb subgroup 19A, dried, sensitivities of major identifiable collection of materials that is available except chive at 260 ppm; and herb subgroups of consumers, including

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infants and children. The nature of the below which carcinogenic effects are Individuals (CSFII) and accumulated toxic effects caused by azoxystrobin are not expected. The point of departure is exposure to the chemical for each discussed in Unit III.A of the Final Rule typically a NOAEL based on an commodity. The following assumptions on Azoxystrobin Pesticide Tolerance endpoint related to cancer effects were made for the chronic exposure published in the Federal Register on though it may be a different value assessments: The chronic dietary September 20, 2002 (67 FR 59169)(FRL– derived from the dose response curve. exposure analysis was performed for the 7198–9). To estimate risk, a ratio of the point of general U.S. Population and all departure to exposure (MOE = point B. Toxicological Endpoints cancer population subgroups using tolerance of departure/exposures) is calculated. A level residues (livestock) and total The dose at which no adverse effects summary of the toxicological endpoints residues of concern (plants; parent and are observed (the NOAEL) from the for azoxystrobin used for human risk metabolites) and 100% crop treated data toxicology study identified as assessment is discussed in Unit III.B. of for the proposed commodities and all appropriate for use in risk assessment is the Final Rule on Azoxystrobin registered uses. used to estimate the toxicological level Pesticide Tolerance published in the iii. Cancer. EPA’s Cancer Assessment of concern (LOC). However, the lowest Federal Register on September 20, 2002 Review Committee (CARC) evaluated dose at which adverse effects of concern (67 FR 59169)(FRL–7198–9). the carcinogenic potential of are identified (the LOAEL) is sometimes C. Exposure Assessment azoxystrobin and classified azoxystrobin used for risk assessment if no NOAEL as ‘‘not likely to be a human was achieved in the toxicology study 1. Dietary exposure from food and carcinogen’’ based on the revised Cancer selected. An uncertainty factor (UF) is feed uses. Tolerances have been Guidelines. applied to reflect uncertainties inherent established (40 CFR 180.507) for the 2. Dietary exposure from drinking in the extrapolation from laboratory combined residues of azoxystrobin, in water. The Agency lacks sufficient animal data to humans and in the or on a variety of raw agricultural monitoring exposure data to complete a variations in sensitivity among members commodities. Tolerances have been comprehensive dietary exposure of the human population as well as established for residues of azoxystrobin analysis and risk assessment for other unknowns. An UF of 100 is in or on a variety of raw agricultural azoxystrobin in drinking water. Because routinely used, 10X to account for commodities at levels ranging from 0.01 the Agency does not have interspecies differences and 10X for ppm (pecans) to 55 ppm (soybean hay), comprehensive monitoring data, intraspecies differences. and on meat, fat, and meat byproducts For dietary risk assessment (other of cattle, goats, hogs, horses, and sheep drinking water concentration estimates than cancer) the Agency uses the UF to at levels ranging from 0.01 to 0.07 ppm, are made by reliance on simulation or calculate an acute or chronic reference and on milk at 0.006 ppm. A time- modeling taking into account data on dose (acute RfD or chronic RfD) where limited tolerance (to expire on 12/31/ the physical characteristics of the RfD is equal to the NOAEL divided 2003) is currently established at 30 ppm azoxystrobin. by the appropriate UF (RfD = NOAEL/ for the head and stem Brassica The Agency uses the FQPA Index UF). Where an additional safety factor vegetables, subgroup 5A. Risk Reservoir Screening Tool (FIRST) or the (SF) is retained due to concerns unique assessments were conducted by EPA to Pesticide Root Zone model/Exposure to the FQPA, this additional factor is assess dietary exposures from Analysis Modeling System (PRZM/ applied to the RfD by dividing the RfD azoxystrobin in food as follows: EXAMS), to produce estimates of by such additional factor. The acute or i. Acute exposure. Acute dietary risk pesticide concentrations in an index chronic Population Adjusted Dose assessments are performed for a food- reservoir. The screening concentration (aPAD or cPAD) is a modification of the use pesticide if a toxicological study has in groundwater (SCI-GROW) model is RfD to accommodate this type of FQPA indicated the possibility of an effect of used to predict pesticide concentrations SF. concern occurring as a result of a one in shallow groundwater. For a For non-dietary risk assessments day or single exposure. In conducting screening-level assessment for surface (other than cancer) the UF is used to this acute risk assessment, EPA used the water EPA will use FIRST (a tier 1 determine the LOC. For example, when Dietary Exposure Evaluation Model model) before using PRZM/EXAMS (a 100 is the appropriate UF (10X to software with the Food Commodity tier 2 model). The FIRST model is a account for interspecies differences and Intake Database (DEEM-FCIDTM) which subset of the PRZM/EXAMS model that 10X for intraspecies differences) the incorporates food consumption data as uses a specific high-end runoff scenario LOC is 100. To estimate risk, a ratio of reported by respondents in the USDA for pesticides. FIRST and PRZM/ the NOAEL to exposures (margin of 1994–1996 and 1998 nationwide EXAMS incorporate an index reservoir exposure (MOE) = NOAEL/exposure) is Continuing Surveys of Food Intake by environment, and a percent crop area calculated and compared to the LOC. Individuals (CSFII) and accumulated factor as an adjustment to account for The linear default risk methodology exposure to the chemical for each the maximum percent crop coverage (Q*) is the primary method currently commodity. The following assumption within a watershed or drainage basin. used by the Agency to quantify was made for the acute exposure None of these models include carcinogenic risk. The Q* approach assessment: A Tier 1 acute dietary consideration of the impact processing assumes that any amount of exposure exposure analysis was performed for (mixing, dilution, or treatment) of raw will lead to some degree of cancer risk. azoxystrobin. water for distribution as drinking water A Q* is calculated and used to estimate ii. Chronic exposure. In conducting would likely have on the removal of risk which represents a probability of this chronic risk assessment, EPA used pesticides from the source water. The occurrence of additional cancer cases the Dietary Exposure Evaluation Model primary use of these models by the (e.g., risk is expressed as 1 x 10-6 or one software with the Food Commodity Agency at this stage is to provide a in a million). Under certain specific Intake Database (DEEM-FCIDTM) which coarse screen for sorting out pesticides circumstances, MOE calculations will incorporates food consumption data as for which it is highly unlikely that be used for the carcinogenic risk reported by respondents in the USDA drinking water concentrations would assessment. In this non-linear approach, 1994–1996 and 1998 nationwide ever exceed human health levels of a ‘‘point of departure’’ is identified Continuing Surveys of Food Intake by concern.

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Since the models used are considered Azoxystrobin is currently registered mechanism of toxicity and to evaluate to be screening tools in the risk for use on residential non-dietary sites the cumulative effects of such assessment process, the Agency does (turf and ornamentals). The risk chemicals, see the policy statements not use estimated environmental assessment was conducted using the released by EPA’s Office of Pesticide concentrations (EECs) from these following residential exposure Programs concerning common models to quantify drinking water assumptions: There is a potential for mechanism determinations and exposure and risk as a %RfD or %PAD. short-term dermal and inhalation procedures for cumulating effects from Instead, drinking water levels of exposures to homeowners who apply substances found to have a common comparison (DWLOCs) are calculated products containing azoxystrobin; mechanism on EPA’s Web site at http:/ and used as a point of comparison however, EPA did not identify dermal /www.epa.gov/pesticides/cumulative/. against the model estimates of a endpoints for azoxystrobin. Because no pesticide’s concentration in water. dermal endpoints could be indentified, D. Safety Factor for Infants and DWLOCs are theoretical upper limits on EPA expects no risk from dermal Children a pesticide’s concentration in drinking exposure to azoxystrobin. There is also 1. In general. Section 408 of the water in light of total aggregate exposure potential for non-dietary, oral exposure FFDCA provides that EPA shall apply to a pesticide in food, and from following lawn treatment. Short- and an additional tenfold margin of safety residential uses. Since DWLOCs address intermediate-term non-dietary, oral for infants and children in the case of total aggregate exposure to azoxystrobin exposure assessments were included for threshold effects to account for prenatal they are further discussed in the toddlers, since EPA selected toxicology and postnatal toxicity and the aggregate risk section in Unit III.E. endpoints for these exposures and there completeness of the data base on Although moderately persistent in is a potential for hand-to-mouth and toxicity and exposure unless EPA soils and stable to hydrolysis, the object-to mouth transfer of residues determines that a different margin of likelihood of azoxystrobin moving into from treated turfgrass and incidential safety will be safe for infants and ground and surface water is low due to ingestion of soil from treated turfgrass. children. Margins of safety are high soil/water partitioning coefficients Postapplication exposures from incorporated into EPA risk assessments and low single application rates. various activities following lawn either directly through use of a MOE However, with multiple applications treatment are considered to be the most analysis or through using uncertainty and repeated usage, azoxystrobin and common and significant in residential (safety) factors in calculating a dose especially its degradate (‘‘compound 2’’, settings. The exposure via incidental level that poses no appreciable risk to (E)-2-2-[6-(2-cyanophenoxy)pyrimidin- ingestion of other plant material may humans. 4-yloxy]-3-methoxyacrylic acid) may occur but is considered negligible. The 2. Prenatal and postnatal sensitivity. eventually build up in environmental residential exposure and risk Azoxystrobin studies have indicated no compartments and move into drinking assessment was conducted using the increased susceptibility of rats or rabbits water resources. application for turf because it is the to in utero and/or postnatal exposure to Based on the Tier I modeling results highest single use rate. Azoxystrobin azoxystrobin. using the FQPA Index Reservoir may be applied to turf at rates of up to 3. Conclusion. There is a complete Screening Tool (FIRST) model, 0.9516 active ingredient (a.i.) per acre toxicity data base for azoxystrobin and azoxystrobin EECs in surface water are five times per year (i.e., not to exceed exposure data are complete or are not likely to exceed 170 parts per billion 5 lb/ai/acre/year). estimated based on data that reasonably (ppb) for the acute (peak) concentration 4. Cumulative exposure to substances accounts for potential exposures. EPA or 33 ppb for the chronic (365–day) with a common mechanism of toxicity. determined that the 10–fold safety factor concentration. These values represent Section 408(b)(2)(D)(v) of the FFDCA for increased susceptibility of infants upper-bound estimates of the requires that, when considering whether and children be removed (i.e., reduced concentrations that might be found in to establish, modify, or revoke a to 1X). The FQPA factor is removed surface water which result from the use tolerance, the Agency consider because: of azoxystrobin on turf. ‘‘available information’’ concerning the • The toxicology data base is The SCI-GROW screening model cumulative effects of a particular complete developed in the Agency estimates pesticide’s residues and ‘‘other • The developmental and potential ground water concentrations substances that have a common reproductive toxicity data did not under hydrologically vulnerable mechanism of toxicity.’’ indicate increased susceptibility of rats conditions. Based on the highest use EPA does not have, at this time, or rabbits to in utero and/or postnatal rate (turf use, nine applications per year, available data to determine whether exposure 10–day interval, and 0.55 lb ai/A/ azoxystrobin has a common mechanism • Unrefined chronic dietary application), the upper-bound of toxicity with other substances. Unlike exposure estimates (assuming all concentration of azoxystrobin was other pesticides for which EPA has commodities contain tolerance level estimated at 3.1 ppb. This value was followed a cumulative risk approach residues) will overestimate dietary used for both acute and chronic risk based on a common mechanism of exposure assessments. This value represents toxicity, EPA has not made a common • Modeling data are used for ground upper-bound estimates of the mechanism of toxicity finding as to and surface source drinking water concentrations that might be found in azoxystrobin and any other substances exposure assessments resulting in ground water which result from the use and azoxystrobin does not appear to estimates considered to be upper-bound of azoxystrobin on turf. produce a toxic metabolite produced by concentrations 3. From non-dietary exposure. The other substances. For the purposes of term ‘‘residential exposure’’ is used in this tolerance action, therefore, EPA has E. Aggregate Risks and Determination of this document to refer to non- not assumed that azoxystrobin has a Safety occupational, non-dietary exposure common mechanism of toxicity with To estimate total aggregate exposure (e.g., for lawn and garden pest control, other substances. For information to a pesticide from food, drinking water, indoor pest control, termiticides, and regarding EPA’s efforts to determine and residential uses, the Agency flea and tick control on pets). which chemicals have a common calculates DWLOCs which are used as a

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point of comparison against the model female), and 1L/10 kg (child). Default pesticide’s uses, levels of comparison in estimates of a pesticide’s concentration body weights and drinking water drinking water may vary as those uses in water (EECs). DWLOC values are not consumption values vary on an change. If new uses are added in the regulatory standards for drinking water. individual basis. This variation will be future, EPA will reassess the potential DWLOCs are theoretical upper limits on taken into account in more refined impacts of residues of the pesticide in a pesticide’s concentration in drinking screening-level and quantitative drinking water as a part of the aggregate water in light of total aggregate exposure drinking water exposure assessments. risk assessment process. to a pesticide in food and residential Different populations will have different 1. Acute risk. Using the exposure uses. In calculating a DWLOC, the DWLOCs. Generally, a DWLOC is assumptions discussed in this unit for Agency determines how much of the calculated for each type of risk acute exposure, the acute dietary acceptable exposure (i.e., the PAD) is assessment used: Acute, short-term, exposure from food to azoxystrobin will available for exposure through drinking intermediate-term, chronic, and cancer. occupy 10% of the aPAD for the U.S. water [e.g., allowable chronic water When EECs for surface water and population, 17% of the aPAD for exposure (mg/kg/day) = cPAD - (average groundwater are less than the calculated children 1–2 years old, 9% of the aPAD food + residential exposure)]. This DWLOCs, EPA concludes with for females 13 years and older, and 10% allowable exposure through drinking reasonable certainty that exposures to of the aPAD for adults 50+ years old. In water is used to calculate a DWLOC. the pesticide in drinking water (when addition, there is potential for acute A DWLOC will vary depending on the considered along with other sources of dietary exposure to azoxystrobin in toxic endpoint, drinking water exposure for which EPA has reliable drinking water. After calculating consumption, and body weights. Default data) would not result in unacceptable DWLOCs and comparing them to the body weights and consumption values levels of aggregate human health risk at EECs for surface and ground water, EPA as used by the USEPA Office of Water this time. Because EPA considers the does not expect the aggregate exposure are used to calculate DWLOCs: 2 liter aggregate risk resulting from multiple to exceed 100% of the aPAD, as shown (L)/70 kg (adult male), 2L/60 kg (adult exposure pathways associated with a in Table 1 of this unit:

TABLE 1.—AGGREGATE RISK ASSESSMENT FOR ACUTE EXPOSURE TO AZOXYSTROBIN

Surface Ground Acute Population Subgroup aPAD (mg/ % aPAD Water EEC Water EEC DWLOC kg) (Food) (ppb) (ppb) (ppb)

U.S. Population ...... 0.67 10 170 3.1 21,000 Children 1–2 years old ...... 0.67 17 170 3.1 5,600 Females 13–49 years ...... 0.67 9 170 3.1 18,000 Adults (50+ years) ...... 0.67 10 170 3.1 21,000

2. Chronic risk. Using the exposure cPAD for females 13–49 years old, and calculating DWLOCs and comparing assumptions described in this unit for 11% for adults 50+ years old. Based on them to the EECs for surface and ground chronic exposure, EPA has concluded the use pattern, chronic residential water, EPA does not expect the that exposure to azoxystrobin from food exposure to residues of azoxystrobin is aggregate exposure to exceed 100% of will utilize 12% of the cPAD for the not expected. In addition, there is the cPAD, as shown in the following U.S. population, 22% of the cPAD for potential for chronic dietary exposure to Table 2: children 1–2 years old, 11% of the azoxystrobin in drinking water. After

TABLE 2.—AGGREGATE RISK ASSESSMENT FOR CHRONIC (NON-CANCER) EXPOSURE TO AZOXYSTROBIN

Surface Ground Chronic Population Subgroup cPAD mg/ % cPAD Water EEC Water EEC DWLOC kg/day (Food) (ppb) (ppb) (ppb)

U.S. Population ...... 0.18 12 33 3.1 5,500 Children 1–2 years ...... 0.18 22 33 3.1 1,400 Females 13–49 years ...... 0.18 11 33 3.1 4,800 Adults 50+ years ...... 0.18 11 33 3.1 5,600

3. Short-term risk. Short-term Using the exposure assumptions to the EECs for chronic exposure of aggregate exposure takes into account described in this unit for short-term azoxystrobin in ground and surface residential exposure plus chronic exposures, EPA has concluded that food water. After calculating DWLOCs and exposure to food and water (considered and residential exposures aggregated comparing them to the EECs for surface to be a background exposure level). result in aggregate MOEs of 1,200 for and ground water, EPA does not expect Azoxystrobin is currently registered adults, and 430 for children 1–2 years short-term aggregate exposure to exceed for use that could result in short-term old. These aggregate MOEs do not the Agency’s level of concern, as shown residential exposure and the Agency has exceed the Agency’s level of concern for in the following Table 3: determined that it is appropriate to aggregate exposure to food and aggregate chronic food and water and residential uses. In addition, short-term short-term exposures for azoxystrobin. DWLOCs were calculated and compared

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TABLE 3.—AGGREGATE RISK ASSESSMENT FOR SHORT-TERM EXPOSURE TO AZOXYSTROBIN

Aggregate Aggregate MOE (Food Level of Surface Ground Short-Term Population Subgroup + Concern Water EEC Water EEC DWLOC Residential) (LOC) (ppb) (ppb) (ppb)

U.S. Population ...... 1,200 100 33 3.1 8,000 Children 1–2 years old ...... 430 100 33 3.1 1,900

4. Intermediate-term risk. and water and intermediate-term addition, intermediate-term DWLOCs Intermediate-term aggregate exposure exposures for azoxystrobin. were calculated and compared to the takes into account residential exposure Using the exposure assumptions EECs for chronic exposure of plus chronic exposure to food and water described in this unit for intermediate- azoxystrobin in ground and surface (considered to be a background term exposures, EPA has concluded that water. After calculating DWLOCs and exposure level). food and residential exposures comparing them to the EECs for surface Azoxystrobin is currently registered aggregated result in aggregate MOEs of and ground water, EPA does not expect for use(s) that could result in 420 for children 1–2 years old. These intermediate-term aggregate exposure to intermediate-term residential exposure aggregate MOEs do not exceed the exceed the Agency’s level of concern, as and the Agency has determined that it Agency’s level of concern for aggregate shown in the following Table 4: is appropriate to aggregate chronic food exposure to food and residential uses. In

TABLE 4.—AGGREGATE RISK ASSESSMENT FOR INTERMEDIATE-TERM EXPOSURE TO AZOXYSTROBIN

Inter- Aggregate Aggregate Surface Ground mediate- Population Subgroup MOE (Food Level of Water EEC Water EEC Term + Concern (ppb) (ppb) DWLOC Residential) (LOC) (ppb)

Children 1–2 years old ...... 420 100 33 3.1 1,600

5. Aggregate cancer risk for U.S. B. International Residue Limits FFDCA by the FQPA, EPA will continue population. There is no evidence for No Codex, Canadian, or Mexican to use those procedures, with mutagenicity or carcinogenicity. Maximum Residue Levels (MRLs) have appropriate adjustments, until the Azoxystrobin has been classified as ‘‘not been established for residues of necessary modifications can be made. likely to be carcinogenic in humans’’ by azoxystrobin. Therefore, no tolerance The new section 408(g) of the FFDCA EPA; therefore, azoxystrobin is not discrepancies exist between countries provides essentially the same process expected to pose a carcinogenic risk. for this chemical. for persons to ‘‘object’’ to a regulation for an exemption from the requirement 6. Determination of safety. Based on V. Conclusion of a tolerance issued by EPA under new these risk assessments, EPA concludes section 408(d) of FFDCA, as was that there is a reasonable certainty that Therefore, the tolerances are established for combined residues of provided in the old sections 408 and no harm will result to the general 409 of the FFDCA. However, the period population, and to infants and children azoxystrobin, methyl (E)-2-[[6-(2- cyanophenoxy)-4-pyrimidinyl]oxy]-∝- for filing objections is now 60 days, from aggregate exposure to azoxystrobin rather than 30 days. residues. (methoxymethylene)-benzeneacetate, and its Z isomer, methyl (Z)-2-[[6-(2- A. What Do I Need to Do to File an ∝ IV. Other Considerations cyanophenoxy)-4-pyrimidinyl]oxy]- - Objection or Request a Hearing? (methoxymethylene)-benzeneacetate, in A. Analytical Enforcement Methodology or on artichoke, globe at 4.0 ppm; You must file your objection or request a hearing on this regulation in Adequate methodology is available for asparagus at 0.04 ppm; brassica, head accordance with the instructions enforcement of these tolerances. The gas and stem, subgroup 5A at 3.0 ppm; herb provided in this unit and in 40 CFR part chromatography/nitrogen phosphorous subgroup 19A, dried, except chive at 178. To ensure proper receipt by EPA, detector (GC/NPD) method (RAM 243/ 260 ppm; and herb subgroup 19A, fresh, except chive at 50 ppm. you must identify docket ID number 04) has undergone a method validation OPP–2003–0196 in the subject line on by the EPA analytical laboratory. EPA VI. Objections and Hearing Requests the first page of your submission. All comments have been incorporated and Under section 408(g) of the FFDCA, as requests must be in writing, and must be the revised method (designated RAM amended by the FQPA, any person may mailed or delivered to the Hearing Clerk 243) will be submitted to FDA for file an objection to any aspect of this on or before August 18, 2003. inclusion in PAM, Volume II as an regulation and may also request a 1. Filing the request. Your objection enforcement method. hearing on those objections. The EPA must specify the specific provisions in The method may be requested from: procedural regulations which govern the the regulation that you object to, and the Chief, Analytical Chemistry Branch, submission of objections and requests grounds for the objections (40 CFR Environmental Science Center, 701 for hearings appear in 40 CFR part 178. 178.25). If a hearing is requested, the Mapes Rd., Ft. Meade, MD 20755–5350; Although the procedures in those objections must include a statement of telephone number: (410) 305–2905; e- regulations require some modification to the factual issues(s) on which a hearing mail address: [email protected]. reflect the amendments made to the is requested, the requestor’s contentions

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on such issues, and a summary of any inclusion in the official record that is Reform Act of 1995 (UMRA) (Public evidence relied upon by the objector (40 described in Unit I.B.1. Mail your Law 104–4). Nor does it require any CFR 178.27). Information submitted in copies, identified by docket ID number special considerations under Executive connection with an objection or hearing OPP–2003–0196, to: Public Information Order 12898, entitled Federal Actions to request may be claimed confidential by and Records Integrity Branch, Address Environmental Justice in marking any part or all of that Information Resources and Services Minority Populations and Low-Income information as CBI. Information so Division (7502C), Office of Pesticide Populations (59 FR 7629, February 16, marked will not be disclosed except in Programs, Environmental Protection 1994); or OMB review or any Agency accordance with procedures set forth in Agency, 1200 Pennsylvania Ave., NW., action under Executive Order 13045, 40 CFR part 2. A copy of the Washington, DC 20460–0001. In person entitled Protection of Children from information that does not contain CBI or by courier, bring a copy to the Environmental Health Risks and Safety must be submitted for inclusion in the location of the PIRIB described in Unit Risks (62 FR 19885, April 23, 1997). public record. Information not marked I.B.1. You may also send an electronic This action does not involve any confidential may be disclosed publicly copy of your request via e-mail to: opp- technical standards that would require by EPA without prior notice. [email protected]. Please use an ASCII Agency consideration of voluntary Mail your written request to: Office of file format and avoid the use of special consensus standards pursuant to section the Hearing Clerk (1900C), characters and any form of encryption. 12(d) of the National Technology Environmental Protection Agency, 1200 Copies of electronic objections and Transfer and Advancement Act of 1995 Pennsylvania Ave., NW., Washington, hearing requests will also be accepted (NTTAA), Public Law 104–113, section DC 20460–0001. You may also deliver on disks in WordPerfect 6.1/8.0 or 12(d) (15 U.S.C. 272 note). Since your request to the Office of the Hearing ASCII file format. Do not include any tolerances and exemptions that are Clerk in Rm.104, Crystal Mall #2, 1921 CBI in your electronic copy. You may established on the basis of a petition Jefferson Davis Hwy., Arlington, VA. also submit an electronic copy of your under section 408(d) of the FFDCA, The Office of the Hearing Clerk is open request at many Federal Depository such as the tolerance in this final rule, from 8 a.m. to 4 p.m., Monday through Libraries. do not require the issuance of a Friday, excluding legal holidays. The proposed rule, the requirements of the telephone number for the Office of the B. When Will the Agency Grant a Regulatory Flexibility Act (RFA) (5 Hearing Clerk is (703) 603–0061. Request for a Hearing? 2. Tolerance fee payment. If you file A request for a hearing will be granted U.S.C. 601 et seq.) do not apply. In an objection or request a hearing, you if the Administrator determines that the addition, the Agency has determined must also pay the fee prescribed by 40 material submitted shows the following: that this action will not have a CFR 180.33(i) or request a waiver of that There is a genuine and substantial issue substantial direct effect on States, on the fee pursuant to 40 CFR 180.33(m). You of fact; there is a reasonable possibility relationship between the national must mail the fee to: EPA Headquarters that available evidence identified by the government and the States, or on the Accounting Operations Branch, Office requestor would, if established resolve distribution of power and of Pesticide Programs, P.O. Box one or more of such issues in favor of responsibilities among the various 360277M, Pittsburgh, PA 15251. Please the requestor, taking into account levels of government, as specified in identify the fee submission by labeling uncontested claims or facts to the Executive Order 13132, entitled it ‘‘Tolerance Petition Fees.’’ contrary; and resolution of the factual Federalism (64 FR 43255, August 10, EPA is authorized to waive any fee issues(s) in the manner sought by the 1999). Executive Order 13132 requires requirement ‘‘when in the judgement of requestor would be adequate to justify EPA to develop an accountable process the Administrator such a waiver or the action requested (40 CFR 178.32). to ensure ‘‘meaningful and timely input refund is equitable and not contrary to by State and local officials in the VII. Statutory and Executive Order the purpose of this subsection.’’ For development of regulatory policies that Reviews additional information regarding the have federalism implications.’’ ‘‘Policies waiver of these fees, you may contact This final rule establishes a tolerance that have federalism implications’’ is James Tompkins by phone at (703) 305– under section 408(d) of the FFDCA in defined in the Executive order to 5697, by e-mail at response to a petition submitted to the include regulations that have [email protected], or by mailing a Agency. The Office of Management and ‘‘substantial direct effects on the States, request for information to Mr. Tompkins Budget (OMB) has exempted these types on the relationship between the national at Registration Division (7505C), Office of actions from review under Executive government and the States, or on the of Pesticide Programs, Environmental Order 12866, entitled Regulatory distribution of power and Protection Agency, 1200 Pennsylvania Planning and Review (58 FR 51735, responsibilities among the various Ave., NW., Washington, DC 20460– October 4, 1993). Because this rule has levels of government.’’ This final rule 0001. been exempted from review under directly regulates growers, food If you would like to request a waiver Executive Order 12866 due to its lack of processors, food handlers and food of the tolerance objection fees, you must significance, this rule is not subject to retailers, not States. This action does not mail your request for such a waiver to: Executive Order 13211, Actions alter the relationships or distribution of James Hollins, Information Resources Concerning Regulations That power and responsibilities established and Services Division (7502C), Office of Significantly Affect Energy Supply, by Congress in the preemption Pesticide Programs, Environmental Distribution, or Use (66 FR 28355, May provisions of section 408(n)(4) of the Protection Agency, 1200 Pennsylvania 22, 2001). This final rule does not FFDCA. For these same reasons, the Ave., NW., Washington, DC 20460– contain any information collections Agency has determined that this rule 0001. subject to OMB approval under the does not have any ‘‘tribal implications’’ 3. Copies for the Docket. In addition Paperwork Reduction Act (PRA), 44 as described in Executive Order 13175, to filing an objection or hearing request U.S.C. 3501 et seq., or impose any entitled Consultation and Coordination with the Hearing Clerk as described in enforceable duty or contain any with Indian Tribal Governments (65 FR Unit VI.A., you should also send a copy unfunded mandate as described under 67249, November 6, 2000). Executive of your request to the PIRIB for its Title II of the Unfunded Mandates Order 13175, requires EPA to develop

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an accountable process to ensure ■ 2. Section 180.507 is amended by demolition landfills by stating that a ‘‘meaningful and timely input by tribal adding alphabetically commodities to construction and demolition landfill officials in the development of the table in paragraph (a)(1) to read as accepting residential lead-based paint regulatory policies that have tribal follows: waste, and no other household waste, is implications.’’ ‘‘Policies that have tribal not a municipal solid waste landfill implications’’ is defined in the § 180.507 Azoxystrobin; tolerances for unit. Today’s action would not prevent residues. Executive order to include regulations a municipal solid waste landfill unit that have ‘‘substantial direct effects on (a) * * * from continuing to receive residential one or more Indian tribes, on the lead-based paint waste. Commodity Parts per relationship between the Federal million DATES: This final rule will become Government and the Indian tribes, or on effective on June 18, 2003. The Agency the distribution of power and ***** finds good cause to make this rule responsibilities between the Federal Artichoke, globe ...... 4.0 effective immediately because today’s Asparagus ...... 0.04 Government and Indian tribes.’’ This final rule provides an additional rule will not have substantial direct ***** Brassica, head and stem, disposal option for residential lead- effects on tribal governments, on the subgroup 5A ...... 3.0 based paint waste. relationship between the Federal ***** ADDRESSES: Copies of the documents Government and Indian tribes, or on the Herb subgroup 19A, dried, relevant to this action (Docket No. distribution of power and except chive ...... 260 RCRA–2001–0017) are available for Herb subgroup 19A, fresh, responsibilities between the Federal public inspection during normal Government and Indian tribes, as except chive ...... 50 ***** business hours from 8:30 a.m. to 4:30 specified in Executive Order 13175. p.m., Monday through Friday, excluding Thus, Executive Order 13175 does not federal holidays, at the RCRA apply to this rule. * * * * * [FR Doc. 03–15261 Filed 6–17–03; 8:45 am] Information Center (RIC), located at EPA West, Room B–102, 1301 Constitution VIII. Congressional Review Act BILLING CODE 6560–50–S Ave., NW. Washington, DC. The Congressional Review Act, 5 U.S.C. 801 et seq., as added by the Small FOR FURTHER INFORMATION CONTACT: For Business Regulatory Enforcement ENVIRONMENTAL PROTECTION general information, contact the RCRA Fairness Act of 1996, generally provides AGENCY Hotline at (800) 424–9346 or TDD (800) 553–7672 (hearing impaired). In the that before a rule may take effect, the 40 CFR Parts 257 and 258 agency promulgating the rule must Washington, DC, metropolitan area, call submit a rule report, which includes a [FRL–7514–7] (703) 412–9810 or TDD (703) 412–3323. For information on specific aspects of copy of the rule, to each House of the RIN 2050–AE86 Congress and to the Comptroller General this rule, contact Paul Cassidy, Municipal and Industrial Solid Waste of the United States. EPA will submit a Criteria for Classification of Solid Division, Office of Solid Waste (mail report containing this rule and other Waste Disposal Facilities and code 5306W), U.S. Environmental required information to the U.S. Senate, Practices and Criteria for Municipal Protection Agency (EPA, HQ), 1200 the U.S. House of Representatives, and Solid Waste Landfills: Disposal of Pennsylvania Avenue, NW, Washington, the Comptroller General of the United Residential Lead-Based Paint Waste States prior to publication of this final DC 20460; (703) 308–7281, rule in the Federal Register. This final AGENCY: Environmental Protection [email protected]. The index and rule is not a ‘‘major rule’’ as defined by Agency (EPA). some supporting materials are available 5 U.S.C. 804(2). ACTION: Final rule. on the Internet. You can find these materials at http://www.epa.gov/ List of Subjects in 40 CFR Part 180 SUMMARY: To help accelerate the pace of epaoswer/non-hw/muncpl/landfill/pb- lead-based paint removal from paint.htm. Environmental protection, residences, and thereby reduce exposure Administrative practice and procedure, to children and adults from the health SUPPLEMENTARY INFORMATION: Agricultural commodities, Pesticides risks associated with lead, EPA is I. General Information and pests, Reporting and recordkeeping promulgating a change to its definition requirements. of ‘‘municipal solid waste landfill unit’’ A. Regulated Entities Dated: June 6, 2003. in both the Criteria for Classification of Entities potentially covered by this Debra Edwards, Solid Waste Disposal Facilities and regulation are public or private Director, Registration Division, Office of Practices and the Criteria for Municipal individuals or groups that generate Pesticide Programs. Solid Waste Landfills. In addition, EPA residential lead-based paint (LBP) waste ■ Therefore, 40 CFR chapter I is is promulgating two new definitions for as a result of abatement, rehabilitation, amended as follows: ‘‘construction and demolition (C&D) renovation and remodeling in homes, landfill’’ and ‘‘residential lead-based residences, and other households. By PART 180—[AMENDED] paint waste.’’ This final rule will ‘‘households,’’ we mean single and expressly allow residential lead-based multiple residences, hotels and motels, ■ 1. The authority citation for part 180 paint waste that is exempted from the bunkhouses, ranger stations, crew continues to read as follows: hazardous waste management quarters, campgrounds, picnic grounds, Authority: 21 U.S.C. 321(q), 346(a) and requirements as household waste to be and day-use recreation areas. Affected 371. disposed of in construction and categories and entities include:

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Category Examples of affected entities

Individuals and firms who generate residential Contractors and do-it-yourselfers who generate and dispose of residential LBP waste as a re- LBP wastes. sult of abatement, rehabilitation, renovation and remodeling in homes, residences, and other households. Construction and demolition waste disposal Owners or operators of construction and demolition landfills that accept residential LBP waste firms. for disposal.

The table above is not intended to be contents of the official public docket, V. How Will States and Tribes Implement exhaustive but, rather, is intended to and to access those documents in the this Rule? provide examples of entities likely to be public docket that are available VI. How Does this Rule Comply with regulated by this action. To determine electronically. Once in the system, Applicable Statutes and Executive Orders? Statutory and Executive Order whether your facility would be select ‘‘search,’’ then key in the Reviews impacted by this action, you should appropriate docket identification A. Executive Order 12866: Regulatory carefully examine the applicability number. Although not all docket Planning and Review criteria in this rule. If you have materials may be available B. Paperwork Reduction Act questions regarding the applicability of electronically, you may still access any C. Regulatory Flexibility Act this action to a particular facility, please of the publicly available docket D. Unfunded Mandates Reform Act contact Paul Cassidy, U.S. EPA, Office materials through the docket facility E. Executive Order 13132: Federalism of Solid Waste (5306W), 1200 identified above in Unit I.B. F. Executive Order 13175: Consultation Pennsylvania Ave. NW., Washington, and Coordination with Indian Tribal C. Acronyms Governments DC 20460; telephone 703–308–7281; e- G. Executive Order 13045: Protection of mail: [email protected]. Acronym Definition Children from Environmental Health B. How Can I Get Copies of This Risks and Safety Risks Document and Other Related CDC ...... Centers of Disease Control and H. Executive Order 13211: Actions that Information? Prevention. Significantly Affect Energy Supply, C&D ...... Construction and Demolition. Distribution, or Use 1. Docket. EPA has established an CFR ...... Code of Federal Regulations. I. National Technology Transfer and official public docket for this action EA ...... Economic Analysis. Advancement Act of 1995 under Docket ID No. RCRA–2001–0017. EPA ...... Environmental Protection Agen- J. Executive Order 12898: Federal Actions The official public docket consists of the cy. to Address Environmental Justice in documents specifically referenced in FR ...... Federal Register. Minority Populations and Low-Income this action, any public comments HUD ...... U.S. Department of Housing Populations K. Congressional Review Act received and other information related and Urban Development. to this action. The official public docket IQ ...... Intelligence Quotient. I. Legal Authority is the collection of materials that is LBP ...... Lead-Based Paint. MSWLF ...... Municipal Solid Waste Landfill. EPA is promulgating this rule available for public viewing at the OMB ...... Office of Management and pursuant to section 1008(a)(3), 2002(a), RCRA Information Center (RIC), located Budget. 4004(a) and 4010(c) of the Resource at EPA West, Room B–102, 1301 OPPTS ...... Office of Prevention, Pes- Conservation and Recovery Act (RCRA), Constitution Ave. NW., Washington DC. ticides, and Toxic Sub- 42 U.S.C. Secs. 6907(a), 6912(a), The Docket Facility is open from 8:30 stances. 6944(a), 6949a(c). We are also correcting OSWER ..... Office of Solid Waste and a.m. to 4:30 p.m., Monday through a typographical error in the existing Friday, excluding legal holidays. The Emergency Response. RCRA ...... Resource Conservation and statement of authority in part 257 by telephone number for the Public amending the citation to 42 U.S.C. Reading Room is (202) 566–1744. In the Recovery Act. RIC ...... RCRA Docket Information Cen- 6949(c) to read ‘‘6949a(c).’’ Washington, DC, metropolitan area, call ter. II. Summary of Proposed Lead-Based 202–566–0270 or TDD 703–412–3323 TC ...... Toxicity Characteristic. (hearing impaired). To review the TCLP ...... Toxicity Characteristic Leaching Paint Rule docket materials in person, we Procedure. A. Proposed Change to the Definition of recommend that the public make an TSCA ...... Toxic Substances Control Act. ‘‘Municipal Solid Waste Landfill appointment by calling 202–566–0270. USEPA ...... United States Environmental (MSWLF) Unit’’ The public can copy a maximum of 100 Protection Agency. pages from the docket at no charge. In its October 23, 2001, proposal (see Additional copies cost $0.15/page. If Outline 66 FR 53566–53573) regarding the you access the information I. Legal Authority disposal of residential lead-based paint electronically, you can download or II. Summary of Proposed Lead-Based Paint waste, the Agency proposed to expressly print copies free of charge. Rule allow construction and demolition 2. Electronic Access. You may access A. Proposed Change to the Definition of landfills to receive residential lead- this Federal Register document ‘‘Municipal Solid Waste Landfill based paint (LBP) waste.1 This was to be electronically through the EPA Internet (MSWLF) Unit’’ accomplished in part by adding a under the ‘‘Federal Register’’ listings at B. Proposed Definition of ‘‘Construction sentence to the definition of municipal and Demolition (C&D) Landfill’’ http.www.epa.gov/fedrgstr. solid waste landfill (MSWLF) unit in 40 C. Proposed Definition of ‘‘Residential CFR 257.2 and 258.2, as follows: ‘‘A An electronic version of the public Lead-Based Paint Waste’’ docket is available through EPA’s D. Rationale for Proposed Rule electronic public docket and comment 1 EPA published a direct final rule at 66 FR 53535 III. Summary of Public Comments and the (Oct. 23, 2001) together with the proposed rule. system, EPA Dockets. You may use EPA Agency’s Responses to those Comments EPA withdrew the direct final rule after receiving Dockets at http://www.epa.gov/edocket/ IV. Other Applicable Federal, State, Tribal, adverse comments. 66 FR 67108 (Dec. 28, 2001). to access the index listing of the and Local Requirements Today’s rule is final action on the proposed rule.

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construction and demolition landfill requirements of subparts A or B of this stakeholders who have seen the that receives residential lead-based part that receives construction and application of RCRA’s hazardous waste paint waste and does not receive any demolition waste and does not receive regulations as a barrier to the cost- other household waste is not a MSWLF hazardous waste (defined in Sec. 261.3 effective abatement of lead hazards; (4) unit.’’ The Agency explained in the of this chapter) other than conditionally the 1988 proposed rule under the Toxic preamble to the proposal that the exempt small quantity generator waste Substances Control Act (TSCA) which existing definition of a MSWLF unit (defined in Sec. 261.5 of this chapter), proposed new TSCA management and includes language which states that a or industrial solid waste (defined in Sec. disposal standards for LBP debris disposal unit ‘‘that receives household 258.2 of this chapter). A C&D landfill generated by contractors from pre-1978 waste’’ is a municipal solid waste typically receives any one or more of the homes and public and commercial landfill unit. This language can be following types of solid wastes: buildings; (5) the 1988 temporary construed to prohibit the disposal of any roadwork material, excavated material, suspension of the toxicity characteristic household waste into a facility that is demolition waste, construction/ for specified lead-based paint debris not designed and operated in renovation waste, and site clearance under RCRA; and (6) the July 31, 2000 conformance with 40 CFR part 258 waste.’’ The proposed rule would add memorandum clarifying the regulatory regulations. As a result the Agency this definition to 40 CFR parts 257 and status under RCRA Subtitle C of wastes proposed to amend the definition of 258. generated as a result of LBP activities, MSWLF unit, to distinguish residential including abatements, renovation and C. Proposed Definition of ‘‘Residential lead-based paint waste, which has been remodeling, and rehabilitations in Lead-Based Paint Waste’’ determined to be a household waste, homes and other residences. In the July from other types of household waste, for Finally, EPA proposed to define 31, 2000 memorandum, the Agency purposes of disposal. ‘‘residential lead-based paint waste’’ to interpreted residential LBP waste as a The definition as proposed is as clarify the scope of the waste stream household waste excluded from the follows: ‘‘Municipal solid waste landfill addressed by the proposed rule. The hazardous waste management (MSWLF) unit means a discrete area of proposed definition of residential lead- requirements pursuant to the household land or an excavation that receives based paint waste is as follows: waste exclusion in 40 CFR 261.4(b)(1), household waste, and that is not a land ‘‘Residential lead-based paint waste thus giving rise to the proposed application unit, surface impoundment, means waste generated as a result of amendments to parts 257 and 258 to injection well, or waste pile, as those lead-based paint activities (including expand disposal options for residential terms are defined in this section. A abatement, rehabilitation, renovation LBP waste to include C&D landfills, as MSWLF unit also may continue to and remodeling) in homes and other well as MSWLF units. receive other types of RCRA Subtitle D residences. The term residential lead- wastes, such as commercial solid waste, based paint waste includes, but is not III. Summary of Public Comments and nonhazardous sludge, and industrial limited to, lead-based paint debris, the Agency’s Response to Those solid waste. Such a landfill may be chips, dust, and sludges.’’ Not included Comments publicly or privately-owned. A MSWLF in the proposed definition of residential The Agency received a total of eight unit may be a new MSWLF unit, an LBP waste were residential LBP comments on the proposed residential existing MSWLF unit or a lateral demolition and deconstruction waste, LBP waste rule: four from construction expansion. A construction and and LBP waste from nonresidential and/or demolition trade associations, demolition landfill that receives structures such as public and and one each from a state, an residential lead-based paint waste and commercial buildings, warehouses, association of state agencies, an does not receive any other household bridges, water towers, and transmission environmental organization, and an waste is not a MSWLF unit.’’ towers. individual. In general, commenters The proposed change was designed to In proposing the definition of supported the proposal to allow simply distinguish residential LBP residential lead-based paint waste, the residential LBP waste to be disposed of waste from other household wastes. The Agency included these particular LBP in C&D landfills. However, some proposal would not alter what a activities because they were limited to commenters requested clarifications of MSWLF could or could not receive. residences and would pose lead hazards the rule or preamble language or MSWLFs would be allowed to continue to occupants, especially to children. We suggested additions to the rule language. to receive residential LBP waste as included the particular waste types (i.e., Definition of Residential Lead-Based household waste. The proposed rule debris, chips, dust, and sludges) because Paint Waste expressly provided an additional land- they are typically generated during the based waste disposal option for named LBP activities. The state commenter argued that the residential LBP waste. proposed rule contained a significant D. Rationale for Proposed Rule flaw by including chips, dust and B. Proposed Definition of ‘‘Construction In the preamble to the proposal, EPA sludges in the definition of ‘‘residential and Demolition Landfill’’ explained the Agency’s rationale and lead-based paint waste,’’ because EPA The October 23, 2001 notice also justification of the proposed changes, as failed to take into account the potential proposed to add a definition of a well as the analytical basis for the for sleet, surface-water or wind-borne construction and demolition (C&D) proposal. The proposal provided a movement of lead paint chips, dust, and waste landfill, which would expressly specific discussion of: (1) The reasons sludges off-site from a C&D landfill. The allow only C&D landfills, and no other that residential lead-based paint is a commenter stated that the placement of types of land disposal units that meet concern to children; (2) the LBP dust, chips and sludges in an open the criteria of 40 CFR part 257, to Congressional enactment of the environment (i.e., a landfill that does receive residential LBP waste. The Residential Lead-Based Paint Hazard not provide for daily cover) over an Agency proposed to define a C&D Reduction Act of 1992 (hereinafter extended period of time, e.g., 30 days, landfill as follows: ‘‘Construction and referred to as Title X of the Housing and may allow a significant rain or wind demolition (C&D) landfill means a solid Community Development Act of 1992, event to transport lead-containing waste disposal facility subject to the or Title X); (3) the concerns of materials off-site. The commenter

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further stated that sudden intense rain ‘‘Lead Paint Can Poison: Is Your Family facility, the containment plastic serves events or winds above 20 to 25 miles at Risk?’’ (http://www.hud.gov/offices/ to mitigate against potential impacts of per hour can transport lead-containing lead/outreach/parents.pdf). water or wind transport. wastes off-site by surface water or air ‘‘Lead Paint Safety—A Field Guide for Additionally, where water or wind currents. The commenter suggested that Painting, Home Maintenance, and transport are problematic, States have requiring daily cover or special Renovation Work’’ (http:// demonstrated their ability, even in the packaging at C&D landfills for the www.hud.gov/offices/lead/training/ absence of a federal requirement, to above-mentioned wastes would mitigate LBPguide.pdf). impose additional requirements for the potential for adverse impact from ‘‘Caution: Lead Paint Handle With Care’’ weekly, monthly, or daily cover as surface water or air transport. (http://www.hud.gov/offices/lead/ necessary to control particulate releases. Because other features of C&D outreach/tradesOKAYTOPRINT.pdf). According to the 1995 report, landfills and LBP waste handling ‘‘Lead Paint Can Poison: Protect Your ‘‘Construction and Demolition Waste practices serve to mitigate potential Family When You Repaint or Landfills,’’ 14 States require on-site C&D impacts from surface water or air Remodel’’. (http://www.hud.gov/ units to provide daily cover, while 19 transport, the Agency does not believe offices/lead/outreach/remodel.pdf) States require daily cover at off-site C&D that requirements for daily cover or HUD also operates the Lead-Based units. Based on these C&D landfill special packaging are needed on the Paint Hazard Control Grant Program that features and LBP waste handling federal level. Surface water transport has as its primary purpose to reduce the practices, the Agency does not believe it is necessary to impose on the federal off-site by sudden intense rain events exposure of young children to lead- would constitute ‘‘non-point source’’ level a requirement for daily cover at based paint hazards in their homes. The pollution under the Clean Water Act. To C&D landfills receiving LBP waste. program provides grants to State and mitigate potential surface water impacts, Two industry association commenters local governments for control of lead- C&D landfills must comply with 40 CFR stated that lead-based paint based paint hazards in privately owned, 257.3–3(c), which requires that a facility architectural debris generated from all low income owner-occupied and rental or practice shall not cause non-point structures, commercial and industrial, housing. These grants are designed to source pollution that violates legal as well as, residential, can safely be stimulate the development of a trained requirements implementing an areawide disposed of in C&D landfills (i.e., and certified hazard evaluation and or statewide water quality management Subtitle D facilities). The commenters control industry. Evaluation and hazard plan approved by EPA under the Clean disagreed with the Agency’s statement Water Act. control work under the program must be in the preamble that demolition and To further mitigate potential water or conducted by either contractors who are deconstruction waste was not similar to air transport, both EPA and the U.S. certified and workers who are trained household waste. The commenters Department of Housing and Urban through a State-accredited program or believe that LBP material handled by Development (HUD) have issued by contractors trained in lead-safe work the demolition industry in commercial guidance for LBP waste management practices in the case of interim controls. and industrial structures is no more calling for the containment of LBP Moreover, as of March 1, 2000, lead dangerous to public health and the wastes in plastic with sealed seams. service providers within the United environment than when LBP appears in EPA’s ‘‘Reducing Lead Hazards When States must be certified (or licensed) a residential structure. Remodeling Your Home’’ EPA 747–K– under an EPA authorized lead program. The Agency wishes to clarify that 97–001 (http://www.epa.gov/lead/ Most of the States have developed and today’s rule is an outgrowth of the July rrpamph.pdf) and EPA’s Model are administering such a program and 31, 2000 Memorandum stating that Renovation Training Course EPA 747– EPA certifies lead service providers in waste generated as a result of LBP B–00–005/6 (http://www.epa.gov/ states that do not have their own activities in homes and other residences opptintr/lead/rrmodel.htm) both call for programs. As of January 2003, 38 States falls within the exclusion for safe and secure disposal. Safe and had EPA-approved state lead programs ‘‘household waste’’ in 40 CFR secure disposal involves placing the that actively certify (license) lead 261.4(b)(1). (See 66 FR 53569.) The LBP wastes in plastic (4–6 mil poly) service providers. scope of this rulemaking concerns only bags that are sealed closed. HUD EPA has also discussed this issue residential lead-based paint wastes and modified the EPA training course and with the National Association of not lead-based paint wastes from developed their own training program to Demolition Contractors (NADC). NADC commercial and industrial structures serve the specific needs of HUD’s re-confirmed EPA’s understanding that because lead-based paint waste from constituents. The HUD training course paint chips and dust are managed in commercial and industrial structures entitled ‘‘Addressing Lead-Based Paint plastic bags. NADC stated that lead- does not fall within the exclusion for Hazards During Renovation, based dust is removed with vacuums ‘‘household waste’’ in 40 CFR Remodeling and Rehabilitation in with HEPA filters and that the vacuum 261.4(b)(1) or the definition of Federally Owned and Assisted bags are removed and then tied closed ‘‘household waste’’ in 40 CFR 258.2. Housing’’ (also referred to as ‘‘The 3R prior to disposal. Paint chips that may Thus, residential LBP waste that would Course’’) (http://www.hud.gov/offices/ fall on a plastic sheet are collected in otherwise be hazardous waste subject to lead/training/3r/3r_course.cfm) was first the plastic sheet which is then placed in the hazardous waste management delivered to remodeling and a tied plastic bag. requirements of Subtitle C of RCRA can rehabilitation workers during HUD’s As stated above, the EPA believes that be managed under Subtitle D of RCRA. nationwide training initiative in 2001– sufficient guidance, literature, training The purpose of this rulemaking is to 2002. HUD’s training recommends that programs, EPA-approved state lead expand Subtitle D disposal options for safe disposal of LBP wastes be programs, and current practices exist so this particular household waste, which, accomplished by means of plastic bags. that whether the LBP waste is in the without today’s rule could only be Other HUD brochures and documents form of chips, dust, or sludge it will be disposed of in municipal solid waste also recommend that LBP wastes be managed appropriately (i.e., landfills pursuant to 40 CFR part 258. placed in plastic bags for safe disposal. containment in plastic bags on site prior The July 31, 2000 Memorandum did These brochures include: to transport to disposal). At the disposal not affect the regulatory status of

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nonresidential LBP waste, such as that scope of the household waste exclusion Definition of Construction and generated during the abatement or and therefore are not included in the Demolition Waste Landfill renovation and remodeling of a definition of ‘‘residential LBP waste.’’ A trade association commenter commercial building. ‘‘Household Although demolition activities and objected to the proposed definition of waste’’ is defined as ‘‘any material renovation activities may produce some ‘‘construction and demolition waste (including garbage, trash and sanitary of the same types of waste, the waste landfill’’ because the proposed rule waste in septic tanks) derived from type is not a factor for consideration would define a C&D waste landfill as households (including single and under 40 CFR 261.4(b)(1), and therefore, one that does not receive ‘‘industrial multiple residences, hotels and motels, today’s final rule continues to read as wastes,’’ as defined in section 258.2. bunkhouses, ranger stations, crew proposed. The Agency wants to make it The commenter objected because the quarters, campgrounds, picnic grounds clear that deconstruction and definition as proposed would preclude and day-use recreation areas).’’ demolition wastes can continue to be a C&D landfill that receives industrial (Emphasis added.) waste in the form of manufacturer’s The Agency recognizes that not all placed in construction and demolition ‘‘off-spec,’’ rejected, or damaged lead-based paint waste, whether from waste landfills provided that these types construction materials from accepting residential, commercial, or industrial of wastes do not exhibit the toxicity or residential lead-based paint waste. Thus sources, is ‘‘hazardous waste’’ which any other characteristic (i.e., are not a C&D landfills in that state would have must be managed under RCRA Subtitle hazardous waste). to choose between residential LBP waste C. Any LBP waste that is not hazardous One commenter was specifically or off spec., damaged, or rejected waste can be safely disposed of in a concerned that the proposed definition Subtitle D landfill, including a C&D construction materials, but not both. of residential lead-based paint waste In the proposed definition of waste landfill. could create confusion about the scope Several commenters stated that the construction and demolition waste of activities that are considered ‘‘lead- proposed rule was not sufficiently clear landfill, the Agency stated that C&D based paint activities’’ under the Toxic as to the distinctions between those LBP waste landfills were not eligible to activities that generate waste that would Substances Control Act (TSCA). The receive ‘‘industrial solid wastes as qualify as ‘‘residential LBP waste’’ (e.g. proposed residential LBP definition defined in 40 CFR 258.2.’’ The abatement, rehabilitation, renovation, states that LBP activities include definition of ‘‘industrial solid waste’’ in and remodeling’’) and those that would abatement, rehabilitation, renovation, section 258.2 covers ‘‘wastes resulting not fall within the scope of the rule (e.g., and remodeling. Regulations from’’ particular manufacturing or ‘‘demolition and deconstruction’’). One promulgated under TSCA define ‘‘lead- industrial processes. In defining C&D of these commenters stated that the based paint activities’’ to mean lead landfills, the Agency was concerned regulated community might believe that inspection, risk assessment, and about C&D waste landfills receiving there is some deconstruction or abatement in the case of target (most wastes generated by manufacturing or demolition occurring whenever you pre-1978) housing (see 40 CFR 745.223). industrial processes and, as such, wrote perform rehabilitation, renovation, Renovation, remodeling, and the definition to exclude such wastes. In remodeling, and perhaps to some extent rehabilitation are not considered lead- practice, industrial process wastes are typically managed on-site, or in limited abatement. The commenter suggested based paint activities under Title X. The cases, sent off-site to private/ that the focus of the final rule be on commenter was concerned that the waste type and not on waste activity. commercial industrial waste facilities. Agency was trying to change the scope Industrial process wastes should not be The Agency distinguishes demolition of the TSCA regulation under the and deconstruction activities from received for disposal at a C&D waste proposed RCRA regulation. The abatement, rehabilitation, renovation, landfill. The commenter was concerned commenter suggested that the term lead- and remodeling on the basis that that off-spec construction products (e.g., demolition and deconstruction result in based paint activities be deleted and toilets or shingles) would not be the elimination of the residential replaced with the phrase ‘‘activities that allowed in a C&D waste landfill because structure, while the residential structure disturb lead-based paint.’’ of the proposed definition. However, the remains where the other listed activities The Agency did not intend or propose Agency views ‘‘off-spec,’’ rejected, or are conducted. The proposed definition to change the scope of the TSCA damaged construction materials as of residential lead based paint waste regulation in the October 2001 proposal. virtually identical in nature to the type does not include residential demolition However, to eliminate any potential of waste that is appropriately received at and deconstruction activities. The confusion, the Agency has decided to a C&D waste landfill and are not proposed definition was limited to LBP change the definition of residential LBP ‘‘industrial solid waste’’ as defined at 40 waste that would be subject to Subtitle wastes to eliminate the words ‘‘lead- CFR 258.2. Because the definition of C of RCRA, except that it is included based paint activities.’’ The definition of industrial solid waste does not within the household waste exclusion residential LBP wastes included in explicitly include materials that do not in 40 CFR 261.4(b)(1). The Agency has meet manufactures’ specifications, are today’s final rule does not use the term applied two criteria to define the scope damaged or rejected for use, EPA ‘‘lead-based paint activities.’’ This of the exclusion: (1) The waste must be believes that industrial waste in the generated by individuals on the definition is as follows: ‘‘Residential form of manufacturer’s ‘‘off-spec,’’ premises of a household, and (2) the lead-based paint waste means waste rejected, or damaged construction waste must be composed primarily of containing lead-based paint, which is materials can be appropriately placed in materials found in the wastes generated generated as a result of activities such a C&D landfill. In addition, the Agency by consumers in their homes (49 FR as abatement, rehabilitation, renovation expects that States would exercise 44978 and 63 FR 70241). In the case of and remodeling in homes and other judgment in what is considered LBP wastes, we have determined that residences. The term residential lead- industrial wastes. Thus, EPA believes demolition and deconstruction, which based paint waste includes, but is not that the definition in today’s final rule result in the elimination of the limited to, lead-based paint debris, accommodates disposal of unused household structure, are outside the chips, dust, and sludges.’’ construction materials that do not meet

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manufacturers’ specifications, are addressing disposal of lead- Today’s amendments are directly damaged or rejected for use. contaminated soils at this time. applicable to landfills in States without an approved permit program under part Another commenter stated that the Summary of Final Rule Changes definition of C&D landfill as proposed 239 and in Indian Country. We could be interpreted to mean that This final rule will expressly allow encourage Tribes to adopt today’s rule conditionally exempt small quantity residential lead-based paint waste to be into their programs to promote lead- generator waste could be accepted in a disposed of in construction and based paint abatement activities in 40 CFR part 257 Subpart A facility. The demolition waste landfills by clearly homes and other residences in Indian commenter suggested a wording change stating that a construction and Country. demolition landfill accepting residential to eliminate this possible VI. How Does This Final Rule Comply misinterpretation. lead-based paint waste, and no other household waste, is not a municipal With Applicable Statutes and Executive EPA does not intend that a C&D solid waste landfill unit. Today’s action Orders? landfill be allowed to receive does not prevent a municipal solid conditionally exempt small quantity Statutory and Executive Order Reviews waste landfill from continuing to generator wastes if the C&D landfill receive residential lead-based paint A. Executive Order 12866: Regulatory meets the requirements of 40 CFR part waste. Two minor changes were made to Planning and Review 257 Subpart A, but does not meet the the final regulatory language based on Under Executive Order 12866, EPA requirements of part 257, subpart B. comments received on the proposal. must determine whether a regulatory Therefore, the Agency has changed the Today’s final rule was modified to action is significant and therefore definition of C&D waste landfill to remove ‘‘LBP activities’’ to one that subject to Office of Management and eliminate any potential confusion. The includes ‘‘activities that disturb LBP.’’ Budget (OMB) review and the other definition has been changed to clarify The definition of construction and provisions of the Executive Order. The that conditionally exempt small demolition waste landfill was changed Order defines a significant regulatory quantity generator wastes can only be to eliminate any confusion so that small action as one that is likely to result in disposed of in a C&D landfill that meets quantity generator waste can only be a rule that may: (1) Have an annual the requirements of 40 CFR part 257, disposed of in a facility that meets the effect on the economy of $100 million Subpart B. requirements of 40 CFR part 257, or more or adversely affect in a material Effect on State Programs subpart B. way the economy, a sector of the economy, productivity, competition, The state association commenter IV. Other Applicable Federal, State, jobs, the environment, public health or indicated that it is important that EPA Tribal, and Local Requirements safety, or State, local, or tribal be explicit that states are not required to Today’s final rule would not alter the governments or communities; (2) create amend their programs to incorporate authority of State, local and Tribal a serious inconsistency or otherwise today’s rule; however the commenter governments to regulate LBP waste more interfere with an action taken or also suggested language to assure States stringently than does EPA. Generators of planned by another agency; (3) that their prior approved programs will residential LBP waste should contact materially alter the budgetary impact of not be reopened regardless of whether the appropriate State environmental entitlements, grants, user fees, or loan they adopt today’s rule or not. EPA agencies to determine if there are programs or rights and obligations or agrees with the comment and has additional or more stringent disposal recipients thereof; or (4) raise novel revised the language in Section V. of requirements for residential LBP waste. legal or policy issues arising out of legal today’s preamble to make this clear. Also, generators are subject to mandates, the President’s priorities, or Lead-Contaminated Soils applicable HUD and/or TSCA the principles set forth in Executive regulations when addressing residential Order 12866. Lastly, a commenter stated that EPA LBP hazards. It has been determined that this rule had missed a golden opportunity to is not a ‘‘significant regulatory action’’ allow lead-contaminated soils to be V. How Will States and Tribes under the terms of Executive Order managed similarly and requested that Implement This Final Rule? 12866 and is therefore not subject to EPA move expeditiously to craft a rule Because today’s final rule is less OMB review. to allow lead-contaminated soils to be stringent than existing federal criteria, EPA has performed a full economic disposed of in C&D and municipal solid States are not required to amend their analysis, ‘‘Economic Analysis of EPA’s waste landfills. The commenter claimed permit programs which have been Final Rule Amending 40 CFR parts 257 that the disposal of lead-contaminated determined to be adequate under 40 and 258,’’ which is available in the soils in C&D landfills and municipal CFR part 239. States have the option of docket for today’s rule. The Economic solid waste landfills is environmentally amending statutory or regulatory Analysis concludes that this rule will safer than is the disposal of lead-based definitions pursuant to today’s final impose no additional costs to parties, paint debris. The commenter also rule. If a state chooses to amend its but may result in cost savings and argued that the cost of managing those permit program pursuant to today’s incremental public health benefits. The soils that fail the TCLP under the RCRA action, the State would be required to rule authorizes the disposal of hazardous waste requirements notify the Regional Administrator of the residential LBP waste in C&D landfills, discourages soil lead abatement from modification as provided by 40 CFR where previously, as ‘‘household waste’’ residences. As discussed previously, 239.12. Whether a State chooses to under the July 31, 2000 policy today’s rulemaking is limited to incorporate today’s rule into its solid memorandum, disposal was authorized providing the C&D landfill disposal waste program has Statutory and only in MSWLFs. Therefore, EPA option for residential lead-based paint Executive Order Reviews no effect on its believes that, in those parts of the waste addressed in the July 31, 2000 existing status with respect to EPA country where costs associated with Memorandum. Lead-contaminated soils approval, i.e., State revisions will not transport to and disposal in C&D were not included in the July 31, 2000 open previously approved solid waste landfills is less expensive than costs Memorandum, thus EPA is not programs for Federal review. associated with MSWLF disposal, some

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residential LBP waste will be diverted Collection Strategies Division, U.S. school district or special district with a from MSWLFs to C&D landfills. Where Environmental Protection Agency population of less than 50,000; and (3) this occurs, generators will benefit from (2822), 1200 Pennsylvania Ave., NW., a small organization that is any not-for- lower waste management and disposal Washington, DC 20460, by email at profit enterprise which is independently costs. [email protected], or by calling (202) owned and operated and is not EPA believes that only residential 260–2740. A copy may also be dominant in its field. LBP waste generators in the Midwest, downloaded off the Internet at After considering the economic Northeast, and South regions will shift http://www.epa.gov/icr. impacts of today’s final rule on small disposal from MSWLFs to C&D landfills, Today’s action does not impose any entities, I certify that this action will not based on an analysis of the relative costs new information collection burden. The have a significant economic impact on of MSWLF and C&D landfill disposal by previously approved information a substantial number of small entities. region. EPA further believes that the collection requirements are contained in This final rule does not impose any new percentage of residential LBP waste that the existing regulations at 40 CFR requirements on small entities. In fact, is affected is proportional to the share 257.30. Burden means the total time, the rule will provide an additional non- of these three regions in the number of effort, or financial resources expended mandatory option for the disposal of housing units with LBP, which is 84.4 by persons to generate, maintain, retain, residential LBP waste, which could percent. Under these assumptions, an or disclose or provide information to or result in less cost in managing estimated 0.87 million tons of for a Federal agency. This includes the residential LBP waste. residential LBP waste may be diverted time needed to review instructions; from MSWLFs to C&D landfills develop, acquire, install, and utilize D. Unfunded Mandates Reform Act annually. This represents 0.73 percent technology and systems for the purposes Title II of the Unfunded Mandates of the total volume of all waste disposed of collecting, validating, and verifying Reform Act of 1995 (UMRA), Public of in MSWLFs annually. This shift in information, processing and Law 104–4, establishes requirements for disposal would save residential LBP maintaining information, and disclosing Federal agencies to assess the effects of waste generators in the Midwest, and providing information; adjust the regulatory actions on State, local, and Northeast, and South regions up to an existing ways to comply with any Tribal governments, and the private estimated $16.76 million annually. The previously applicable instructions and sector. Under Section 202 of the UMRA, savings accruing to generators of requirements; train personnel to be able EPA generally must prepare a written residential LBP abatement waste is to respond to a collection of estimated at $0.79 million per year, information; search data sources; statement, including a cost-benefit while the savings accruing to generators complete and review the collection of analysis, for proposed and final rules of residential renovation and information; and transmit or otherwise with ‘‘Federal mandates’’ that may remodeling waste is $15.98 million per disclose the information. result in expenditures to State, local, year. An Agency may not conduct or and tribal governments, in the aggregate, EPA estimates that of the $0.79 sponsor, and a person is not required to or to the private sector, of $100 million million in savings that could accrue to respond to a collection of information, or more in any one year. Before generators of residential LBP abatement unless it displays a currently valid OMB promulgating an EPA rule for which a waste, an estimated 39.7 percent, or control number. The OMB control written statement is needed, Section 205 $0.31 million, will be generated numbers for EPA’s regulations are listed of the UMRA generally requires EPA to annually in the public housing sector. in 40 CFR part 9 and 48 CFR Chapter identify and consider a reasonable EPA assumes that in the public sector, 15. number of alternatives and adopt the any savings in residential LBP waste least costly, most cost effective or least C. Regulatory Flexibility Act management and disposal costs will be burdensome alternative that achieves used to conduct additional LBP The Regulatory Flexibility Act (RFA), the objective of the rule. The provisions abatements. Given an average cost for as amended by the Small Business of Section 205 do not apply when they LBP abatement in public housing units Regulatory Enforcement Fairness Act of are inconsistent with applicable law. of $3,650, the $0.31 million in annual 1996 (SBREFA), 5 U.S.C. 601 et seq., Moreover, Section 205 allows EPA to savings would fund an additional 86 generally requires an agency to prepare adopt an alternative other than the least abatements each year. This ensuing a regulatory flexibility analysis of any costly, most cost-effective or least increase in LBP abatement projects rule subject to notice and comment burdensome alternative if the would result in a more rapid reduction rulemaking requirements under the Administrator publishes with the final in the potential for exposure to the Administrative Procedure Act or any rule an explanation why that alternative hazards of LBP, especially for children. other statute, unless the agency certifies was not adopted. Before EPA establishes These hazards include decreased that the rule will not have a significant any regulatory requirements that may intelligence (i.e., lower IQ), behavioral economic impact on a substantial significantly or uniquely affect small problems, reduced physical stature and number of small entities. Small entities governments, including tribal growth, and impaired hearing. include small businesses, small governments, it must have developed organizations, and small governmental under Section 203 of the UMRA a small B. Paperwork Reduction Act jurisdictions. government agency plan. The plan must The Office of Management and Budget For purposes of assessing the impacts provide for notifying potentially (OMB) has approved the information of today’s final rule on small entities, a affected small governments, enabling collection requirements contained in small entity is defined as: (1) A small officials of affected small governments this rule under the provisions of the business that is primarily engaged in to have meaningful and timely input in Paperwork Reduction Act, 44 U.S.C. lead paint removal as described in the the development of EPA regulatory 3501 et seq. and has assigned OMB North American Industry Classification proposals with significant Federal control number 2050–0154. Copies of System (see http://www.sba.gov/size/ intergovernmental mandates, and the ICR document(s) may be obtained SIC2NAICSmain.html); (2) a small informing, educating, and advising from Susan Auby, by mail at the Office governmental jurisdiction that is a small governments on compliance with of Environmental Information, government of a city, county, town, the regulatory requirements.

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Today’s final rule contains no Federal Federal government and Indian tribes, I. National Technology Transfer and mandates (under the regulatory as specified in Executive Order 13175. Advancement Act of 1995 provisions of Title II of the UMRA) for Today’s final rule would expressly Section 12(d) of the National State, local, or tribal governments or the provide an additional option for Technology Transfer and Advancement private sector. This final rule does not disposal of certain waste applicable in Act of 1995 (NTTAA), Pub L. 104–113, impose any enforceable duty on any Indian Country, but would not create Sec. 12(d) (15 U.S.C. 272 note) directs State, local or tribal governments or the any mandate on Indian tribal us to use voluntary consensus standards private sector. Thus, today’s final rule is governments. Thus, Executive Order in our regulatory activities unless to do not subject to the requirements of 13175 does not apply to this rule. so would be inconsistent with sections 202 and 205 of UMRA. G. Executive Order 13045: Protection of applicable law or otherwise impractical. E. Executive Order 13132: Federalism Children From Environmental Risks and Voluntary consensus standards are Executive Order 13132, entitled Safety Risks technical standards (for example, ‘‘Federalism’’ (64 FR 43255, August 10, Executive Order 13045, ‘‘Protection of materials specifications, test methods, 1999), requires EPA to develop an Children from Environmental Health sampling procedures, and business accountable process to ensure Risks and Safety Risks’’ applies to any practices) that are developed or adopted ‘‘meaningful and timely input by State rule that: (1) Is determined to be by voluntary consensus standards and local officials in the development of ‘‘economically significant’’ as defined bodies. The NTTAA directs EPA to regulatory policies that have federalism under Executive Order 12866, and (2) provide Congress, through OMB, implications.’’ Policies that have concerns an environmental health or explanations when we decide not to use federalism implications’ is defined in safety risk that EPA has reason to available and applicable voluntary the Executive Order to include believe may have a disproportionate consensus standards. Today’s final rule regulations that have ‘‘substantial direct effect on children. If the regulatory does not involve technical standards, effects on the States, on the relationship action meets both criteria, the Agency voluntary or otherwise. Therefore, the between the national government and must evaluate the environmental health NTTAA does not apply to today’s final the States, or on the distribution of or safety effects of the planned rule on rule. power and responsibilities among the children, and explain why the planned J. Executive Order 12898: Federal various levels of government.’’ regulation is preferable to other Action To Address Justice in Minority This final rule does not have potentially effective and reasonably Populations and Low-Income federalism implications. It will not have feasible alternatives considered by the Populations substantial direct effects on the States, Agency. on the relationship between the national This final rule is not subject to Under Executive Order 12898, government and the States, or on the Executive Order 13045 because it is not ‘‘Federal Actions to Address distribution of power and an economically significant rule as Environmental Justice in Minority responsibilities among the various defined by Executive Order 12866. Populations and Low-Income levels of government, as specified in However, this rule will affect decisions Populations,’’ as well as through EPA’s Executive Order 13132. As explained in involving the environmental health or April 1995, ‘‘Environmental Justice Section V. of this preamble, none of safety risks to children. In fact, it will Strategy, OSWER Environmental Justice today’s proposed revisions are more benefit children by allowing Task Force Action Agenda Report,’’ and stringent or broaden the scope of the environmentally protective disposal of the National Environmental Justice existing Federal requirements. residential lead-based paint waste in Advisory Council, EPA has undertaken Therefore, States are not required to C&D landfills, which is less costly than to incorporate environmental justice adopt the revision to the definition of disposal in MSWLFs in certain areas of into its policies and programs. EPA is MSWLF unit nor the additional the U.S., therefore reducing the cost of committed to addressing environmental definitions of construction and lead abatements. Reducing the cost of justice concerns, and is assuming a demolition (C&D) landfill and LBP abatements will also reduce the leadership role in environmental justice residential lead-based paint waste in amount of time needed to complete initiatives to enhance environmental today’s rule. Thus, Executive Order abatements in public housing. Lower quality for all residents of the United 13132 does not apply to this final rule. abatement costs may increase the States. The Agency’s goals are to ensure amount of private homes undergoing that no segment of the population, F. Executive Order 13175: Consultation abatements. By reducing costs regardless of race, color, national origin, and Coordination With Indian Tribal associated with the disposal of LBP or income, bears disproportionately Governments waste, the Agency believes that the high and adverse human health and Executive Order 13175, entitled number of abatements may marginally environmental effects as a result of ‘‘Consultation and Coordination with increase, thus resulting in a reduction of EPA’s policies, programs, and activities. Indian Tribal Governments’’ (65 FR the number of children exposed to LBP. Today’s final rule is not expected to 67249, November 6, 2000), requires EPA negatively impact any community, and to develop an accountable process to H. Executive Order 13211: Actions That therefore is not expected to cause any ensure ‘‘meaningful and timely input by Significantly Affect Energy Supply, disproportionately high and adverse tribal officials in the development of Distribution, or Use impacts to minority or low-income regulatory policies that have tribal This proposed rule is not a communities versus non-minority or implications.’’ This final rule does not ‘‘significant energy action’’ as defined in affluent communities. On the contrary, have tribal implications as specified in Executive Order 13211, ‘‘Actions since the rule will reduce the cost of Executive Order 13175. It will not have Concerning Regulations That performing LBP abatements in certain substantial direct effects on tribal Significantly Affect Energy Supply, regions of the U.S., EPA believes that governments, on the relationship Distribution, or Use’’ (66 FR 28355 (May the savings will afford public housing between the Federal government and 22, 2001)) because it will not have a authorities, in particular, the Indian tribes, or on the distribution of significant adverse effect on the supply, opportunity to conduct additional power and responsibilities between the distribution, or use of energy. abatements of LBP hazards in affected

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housing units. Tenants of public Construction and demolition (C&D) ■ b. By revising the definition of housing units are possibly more likely landfill means a solid waste disposal ‘‘Municipal solid waste landfill to be minority and lower-income facility subject to the requirements of (MSWLF) unit.’’ households, and the rule should have subparts A or B of this part that receives The revision and additions read as the effect of providing a differential construction and demolition waste and follows: benefit to such populations. does not receive hazardous waste (defined in § 261.3 of this chapter) or K. Congressional Review Act § 258.2 Definitions. industrial solid waste (defined in * * * * * The Congressional review Act, 5 § 258.2 of this chapter). Only a C&D U.S.C. 801 et seq., as added by the Small landfill that meets the requirements of Construction and demolition (C&D) Business Regulatory Enforcement subpart B of this part may receive landfill means a solid waste disposal Fairness Act of 1996, generally provides conditionally exempt small quantity facility subject to the requirements in that, before a rule may take effect, the generator waste (defined in § 261.5 of part 257, subparts A or B of this chapter agency promulgating the rule must this chapter). A C&D landfill typically that receives construction and submit a rule report, which includes a receives any one or more of the demolition waste and does not receive copy of the rule, to each House of the following types of solid wastes: hazardous waste (defined in § 261.3 of Congress and to the Comptroller General roadwork material, excavated material, this chapter) or industrial solid waste of the United States. EPA will submit a demolition waste, construction/ (defined in § 258.2 of this chapter). Only report containing this rule and other renovation waste, and site clearance a C&D landfill that meets the required information to the U.S. Senate, waste. requirements of 40 CFR part 257, the U.S. House of Representatives, and * * * * * subpart B may receive conditionally the Comptroller General of the United Municipal solid waste landfill exempt small quantity generator waste States prior to publication of the rule in (MSWLF) unit means a discrete area of (defined in § 261.5 of this chapter). A the Federal Register. A major rule land or an excavation that receives C&D landfill typically receives any one cannot take effect until 60 days after it household waste, and that is not a land or more of the following types of solid is published in the Federal Register. application unit, surface impoundment, wastes: roadwork material, excavated This action is not a ‘‘major rule’’ as injection well, or waste pile, as those material, demolition waste, defined by 5 U.S.C., 804(2). This rule terms are defined in this section. A construction/renovation waste, and site will be effective on June 18, 2003. MSWLF unit also may receive other clearance waste. List of Subjects types of RCRA Subtitle D wastes, such * * * * * as commercial solid waste, 40 CFR Part 257 nonhazardous sludge, and industrial Municipal solid waste landfill Environmental protection, Waste solid waste. Such a landfill may be (MSWLF) unit means a discrete area of treatment and disposal. publicly or privately owned. A MSWLF land or an excavation that receives household waste, and that is not a land 40 CFR Part 258 unit may be a new MSWLF unit, an existing MSWLF unit or a lateral application unit, surface impoundment, Environmental protection, Reporting expansion. A construction and injection well, or waste pile, as those and recordkeeping requirements, Waste demolition landfill that receives terms are defined under § 257.2 of this treatment and disposal, Water pollution residential lead-based paint waste and chapter. A MSWLF unit also may control. does not receive any other household receive other types of RCRA Subtitle D Dated: June 12, 2003. waste is not a MSWLF unit. wastes, such as commercial solid waste, Christine Todd Whitman, * * * * * nonhazardous sludge, conditionally Administrator. Residential lead-based paint waste exempt small quantity generator waste and industrial solid waste. Such a ■ For reasons set out in the preamble, means waste containing lead-based title 40, chapter I of the Code of Federal paint, which is generated as a result of landfill may be publicly or privately Regulations is amended as follows: activities such as abatement, owned. A MSWLF unit may be a new rehabilitation, renovation and MSWLF unit, an existing MSWLF unit PART 257—[AMENDED] remodeling in homes and other or a lateral expansion. A construction residences. The term residential lead- and demolition landfill that receives ■ 1. The authority citation for part 257 is based paint waste includes, but is not residential lead-based paint waste and revised to read as follows: limited to, lead-based paint debris, does not receive any other household Authority: 42 U.S.C. 6907(a)(3), 6912(a)(1), chips, dust, and sludges. waste is not a MSWLF unit. 6944(a), and 6949a(c); 33 U.S.C. 1345(d) and (e). * * * * * * * * * * Residential lead-based paint waste ■ 2. Section 257.2 is amended: PART 258—[AMENDED] ■ a. By adding in alphabetical order the means waste containing lead-based definitions for ‘‘Construction and ■ 1. The authority citation for part 258 paint, which is generated as a result of demolition (C&D) landfill’’ and continues to read as follows: activities such as abatement, rehabilitation, renovation and ‘‘Residential lead-based paint waste,’’ Authority: 33 U.S.C. 1345(d) and (e); 42 and U.S.C. 6902(a), 6907, 6912(a), 6944, 6945(c) remodeling in homes and other ■ b. By revising the definition of and 6949a(c). residences. The term residential lead- ‘‘Municipal solid waste landfill based paint waste includes, but is not ■ (MSWLF) unit.’’ 2. Section 258.2 is amended: limited to, lead-based paint debris, The revision and additions read as ■ a. By adding in alphabetical order the chips, dust, and sludges. follows: definitions for ‘‘Construction and * * * * * demolition (C&D) landfill’’ and § 257.2 Definitions. ‘‘Residential lead-based paint waste,’’ [FR Doc. 03–15363 Filed 6–17–03; 8:45 am] * * * * * and BILLING CODE 6560–50–P

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DEPARTMENT OF TRANSPORTATION of the DWPA. A deepwater port must be This amendment to 49 CFR part 1 to licensed by the Secretary. To date, reflect the Secretary’s delegation of his Office of the Secretary LOOP LLC is the only offshore authority to issue, transfer, amend or deepwater port facility licensed by the reinstate a license for the construction 49 CFR Part 1 Secretary under the DWPA. LOOP LLC’s and operation of a deepwater port to the [Docket No. OST 1999–6189] License was issued on January 17, 1977, Maritime Administrator relates solely to and was amended and updated on June departmental organization, procedure, RIN 9991–AA37 1, 2000. and practice. Therefore, notice and The Commandant of the United States comment are unnecessary under 5 Organization and Delegation of Powers Coast Guard (USCG) and the U.S.C. 553(b). Further, since the and Duties, Update of Secretarial Administrator of the Maritime amendment expedites the MARAD’s Delegations Administration (MARAD) have operated ability to meet the statutory intent of the AGENCY: Office of the Secretary, under delegated authority to coordinate applicable laws and regulations covered Department of Transportation. the processing of applications for the by this delegation, the Secretary finds ACTION: Final rule. issuance, transfer, amendment, or good cause under 5 U.S.C. 553(d)(3) for reinstatement of a license for the the final rule to be effective on the date SUMMARY: The Secretary of construction and operation of a of publication in the Federal Register. Transportation (Secretary) is delegating deepwater port. 62 FR 11382 (March 12, Regulatory Process Matters to the Maritime Administrator his 1997); 49 CFR 1.46(s) and 1.66(aa). The authority to issue, transfer, amend, or USCG has the additional statutory Regulatory Assessment reinstate a license for the construction responsibility to approve an operations This rulemaking is a nonsignificant and operation of a deepwater port as manual for a deepwater port. 33 U.S.C. regulatory action under section 3(f) of provided for in the Deepwater Port Act, 1503(e)(1). The USCG retained the Executive Order 12866 and has not been of 1974, as amended. Section 106 of the statutory and delegated authorities upon reviewed by the Office of Management Maritime Transportation Security Act of its transfer to the Department of and Budget under that Order. This rule 2002 amended the Deepwater Port Act Homeland Security (Department of is also not significant under the to include facilities that transport Homeland Security Delegation Number: regulatory policies and procedures of natural gas from the United States outer 0170, § 2. (75), March 3, 2003; Pub. L. the Department of Transportation, 44 FR continental shelf. This rule does not 107–296, section 888.). This rule does 11034. change the previous delegation of not change the authorities delegated to This rule does not impose unfunded license processing functions to the USCG and to MARAD nor does it mandates or requirements that will have United States Coast Guard, now part of change the coordination between the any impact on the quality of the human the Department of Homeland Security, USCG and MARAD for processing environment. and to the Maritime Administration. license applications. The rule clarifies The two agencies will continue to that the authorities of USCG and Small Business Impact coordinate their processing of the MARAD for processing license The Regulatory Flexibility Act of license applications. The rule also does applications include the authorities to 1980, 5 U.S.C. 601 et seq., (Act) was not change the previous delegation of process an application for a license enacted by Congress to ensure that small Deepwater Port Act authority to the reinstatement. 33 U.S.C. 1503(b) and (f) entities are not unnecessarily and Administrator of the Research and (as amended by Pub. L. 98–419, Sept. disproportionately burdened by Special Programs Administration. 25, 1984). government regulations. The Act This rule does not change the EFFECTIVE DATE: June 18, 2003. requires agencies to review proposed Secretary’s previous delegation of regulations that may have a significant FOR FURTHER INFORMATION CONTACT: Ms. DWPA authority to the Administrator of economic impact on a substantial Nancy Kessler, Senior Attorney- the Research and Special Programs Advisor, Office of the Assistant General number of small entities. For purposes Administration (RSPA) in 49 CFR of this rule, small entities include all Counsel for Environmental, Civil Rights, 1.53(a)(3) for the establishment, small businesses that are potential and General Law, Department of enforcement, and review of regulations offerors and contractors bidding on Transportation, Room 10102, 400 concerning the safe construction, Department of Transportation proposed Seventh Street, SW., Washington, DC operation or maintenance of pipelines acquisitions. The Act does not apply to 20590, Phone: (202) 366–9154. on Federal lands and the Outer this rulemaking, since a notice of SUPPLEMENTARY INFORMATION: This rule Continental Shelf (33 U.S.C. 1520). proposed rulemaking was not required. revises the Secretary’s reservation of By Federal Register notices dated, However, the Department certifies that authority under the Deepwater Port Act, respectively, December 27, 2002 (67 FR this rule does not have a significant as amended. The Secretary is delegating 79234), and January 23, 2003 (68 FR economic impact on a substantial to the Maritime Administrator his 3299), the Department of Transportation number of small entities. The rule authority to issue, transfer, amend, or through the USCG and MARAD gave makes administrative changes to 49 CFR reinstate a license for the construction notice, as required by the DWPA, of Part 1; therefore, a Regulatory Flexibility and operation of a deepwater oil or applications filed by Port Pelican LLC Analysis has not been performed. natural gas port as provided for in the and El Paso Energy Bridge Gulf of Deepwater Port Act of 1974, as Mexico, LLC for licenses to own, Collection of Information amended, 33 U.S.C. 1501–1524 (DWPA). construct, and operate deepwater This rule calls for no new collection The DWPA, as amended by section 106 natural gas port facilities. Since then, of information under the Paperwork of the Maritime Transportation Security MARAD and the USCG have been Reduction Act of 1995 (44 U.S.C. 3501– Act of 2002, Pub. L. 107–295, 116 coordinating the processing of these 3520). STAT. 2064 at 286 (MTSA), governs the applications. By this rule, MARAD has licensing of any offshore facility used to the authority over the issuance of the Federalism Assessment handle and transport petroleum and licenses for the respective applicants This proposed rule has been reviewed natural gas, pursuant to the amendment and for any future applicants. in accordance with the principles and

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criteria contained in Executive Order PART 1—[AMENDED] (aa) * * * 13132 dated August 4, 1999, and it is ■ 1. The authority citation for part 1 is (1) The authority to issue, transfer, determined that this action does not revised to read as follows: amend, or reinstate a license for the have a substantial direct effect on the construction and operation of a Authority: 49 U.S.C. 322; 46 U.S.C. States, or the relationship between the deepwater port (33 U.S.C. 1503(b)). national government and the States, or 2104(a); 28 U.S.C. 2672; 31 U.S.C. 3711(a)(2); Pub. L. 101–552, 104 Stat. 2736; Pub. L. 106– (2) The authority to process on the distribution of power and 159, 113 Stat. 1748; Pub. L. 107–71, 115 Stat. applications for the issuance, transfer, responsibilities among the various 597; Pub. L. 107–295. amendment, or reinstatement of a levels of government. This rule will not ■ 2. In § 1.44, revise paragraph (o) to read license for the construction and limit the policymaking discretion of the as follows: operation of a deepwater port (33 U.S.C. State nor preempt any State law or 1503(b)), as amended, in coordination regulation. § 1.44 Reservation of authority. * * * (o) Deepwater ports. Repealed. with the Commandant of the Coast List of Subjects in 49 CFR Part 1 * * * * * Guard. Authority delegations (Government ■ 3. In § 1.66, redesignate paragraphs * * * * * agencies), Organizations and functions (aa)(1) through (6) as paragraphs (aa)(2) Issued in Washington, DC on this 4th day (Government agencies). through (7). Add a new paragraph (aa)(1) of June, 2003. and revise newly designated (aa)(2) to Norman Y. Mineta, ■ In consideration of the foregoing, Part read as follows: 1 of Title 49, Code of Federal Secretary of Transportation. Regulations, is amended as follows: § 1.66 Delegations to the Maritime [FR Doc. 03–15400 Filed 6–17–03; 8:45 am] Administrator. BILLING CODE 4910–62–P * * * * *

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Proposed Rules Federal Register Vol. 68, No. 117

Wednesday, June 18, 2003

This section of the FEDERAL REGISTER Eastern Time, Monday through Friday, Another exception concerns certain contains notices to the public of the proposed except holidays at the above address. referenda conducted during specified issuance of rules and regulations. The FOR FURTHER INFORMATION CONTACT: periods by a State relating to the purpose of these notices is to give interested Marlene M. Betts, Agricultural continuation or termination of a QSSB persons an opportunity to participate in the or State soybean assessment. rule making prior to the adoption of the final Marketing Specialist, Marketing rules. Programs Branch, 202/720–1115. Regulatory Flexibility Act SUPPLEMENTARY INFORMATION: AMS has determined that this DEPARTMENT OF AGRICULTURE Executive Order 12866 proposed rule will not have a significant The Office of Management and Budget impact on a substantial number of small Agricultural Marketing Service (OMB) has waived the review process entities as defined by the Regulatory required by Executive Order 12866 for Flexibility Act (5 U.S.C. 601 et seq.), 7 CFR Part 1220 this action. because it only revises the remittance of assessments and reports from a monthly Executive Order 12988 [No. LS–02–14] basis to a quarterly basis for certain This proposed rule has been reviewed States or regions. The States or regions Amendment to the Soybean Promotion under Executive Order 12988, Civil of Delaware, Louisiana, South Carolina, and Research Rules and Regulations Justice Reform. This proposal is not Texas, Eastern Region, and the Western intended to have a retroactive effect. Region will be changed from monthly AGENCY: Agricultural Marketing Service, The Act provides that administrative remitting States or regions to quarterly USDA. proceedings must be exhausted before remitting States or regions to reduce ACTION: Proposed rule. parties may file suit in court. Under administrative costs. Because of the § 1971 of the Act, a person subject to the minimal number of first purchasers, SUMMARY: This proposed rule would Soybean Promotion and Research Order producers, and total remittances from amend the Soybean Promotion and (Order) may file a petition with the these States and regions, allowing the Research Rules and Regulations (Rules Department of Agriculture (Department) States or regions to remit and report and Regulations) established under the stating that the Order, any provision of assessments on a quarterly basis would Soybean Promotion, Research, and the Order, or any obligation imposed in benefit QSSBs, the States and regions, Consumer Information Act (Act) by connection with the Order, is not in and the United Soybean Board (Board) requiring first purchasers of soybeans accordance with law and requesting a by reducing the administrative costs of and producers marketing processed modification of the Order or an remitting and reporting assessments on soybeans or soybean products of a exemption from the Order. The a monthly basis. The proposed action producer’s own production in the States petitioner is afforded the opportunity would likely reduce administrative or regions of Delaware, Louisiana, South for a hearing on the petition. After a costs by approximately $10,000. As Carolina, Texas, Eastern Region, and the hearing, the Department would rule on such, these changes will not have a Western Region, to remit and report the petition. The Act provides that the significant impact on a substantial assessments on a quarterly basis rather district courts of the United States in number of small entities. There are an than a monthly basis. This proposed any district in which such person is an estimated 30,000 soybean producers change would reduce the administrative inhabitant, or has their principal place who pay assessments and an estimated costs of monthly reporting imposed on of business, has jurisdiction to review 150 first purchasers who collect these smaller soybean producing States the Department’s ruling on the petition, assessments in the four affected States and regions. if a complaint for this purpose is filed and two regions. There are six QSSBs DATES: Written comments must be within 20 days after the date of the entry that would be affected under this received by July 18, 2003. of the ruling. Further, § 1974 of the Act proposed rule. Most of these entities ADDRESSES: Send a copy of your provides, with certain exceptions, that would be considered small entities comments to Kenneth R. Payne, Chief; nothing in the Act may be construed to under the criteria established by the Marketing Programs Branch; Livestock preempt or supersede any other program Small Business Administration (13 CFR and Seed Program; Agricultural relating to soybean promotion, research, 121.201). Marketing Service (AMS), USDA, Room consumer information, or industry Paperwork Reduction Act 2638–S; STOP 0251; 1400 Independence information organized and operated Avenue, SW.; Washington, DC 20250– under the laws of the United States or In accordance with the Paperwork 0251. Comments may also be sent any State. One exception in the Act Reduction Act of 1990 (44 U.S.C. electronically to concerns assessments collected by Chapter 35), the reporting and [email protected] or by Qualified State Soybean Boards recordkeeping requirements included in facsimile at 202/720–1125. All (QSSBs). The exception provides that to 7 CFR part 1220 were previously comments should reference the docket ensure adequate funding of the approved by OMB and were assigned number LS–02–14, the date, and the operations of QSSBs under the Act, no OMB control number 0581–0093. The page number of this issue of the Federal State law or regulation may limit or purpose of this proposed rule is to Register. Comments will be available for have the effect of limiting the full change the remitting and reporting of public inspection via the Internet at amount of assessments that a QSSB in assessments to a quarterly basis from a http://www.ams.usda.gov/lsg/mpb/rp- that State may collect, and which is monthly basis in four soybean soy.htm or between 8 a.m. and 4:30 p.m. authorized to be credited under the Act. producing States and two regions. There

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are a minimal number of first by approximately $10,000 if first Monthly Quarterly purchasers and producers in these four purchasers of soybeans and producers States and two regions. This change marketing processed soybeans and Virginia would not substantially impact the soybean products of a producer’s own Eastern Region overall total burden hours. As a result, production in the States and regions of Western Region no change to the previously submitted Delaware, Louisiana, South Carolina, burden estimate is necessary. Texas, the Eastern Region, and the * * * * * Background and Proposed Changes Western Region could remit and report Dated: June 12, 2003. assessments on a quarterly basis. Kenneth C. Clayton, The Act (7 U.S.C. 6301–6311) Producers that market soybeans to first Acting Administrator, Agricultural Marketing provides for the establishment of a purchasers would continue to pay the Service. coordinated program of promotion and assessment at the time of settlement. [FR Doc. 03–15318 Filed 6–17–03; 8:45 am] research designed to strengthen the Due to the minimal number of first BILLING CODE 3410–02–P soybean industry’s position in the purchasers and total remittances in marketplace, and to maintain and these States and regions, allowing the expand domestic and foreign markets States or regions to remit quarterly DEPARTMENT OF TRANSPORTATION and uses for soybeans and soybean would be beneficial to the States, products. The program is financed by an regions, and the Board by reducing the Federal Aviation Administration assessment of 0.5 of 1 percent of the net administrative costs of collecting market price of soybeans sold by assessments. 14 CFR Part 39 producers. The final Order establishing A 30-day comment period is provided a soybean promotion, research, and for interested persons. For the [Docket No. 2001–NM–370–AD] consumer information program was aforementioned reasons, a 30-day RIN 2120–AA64 published in the July 9, 1991, issue of comment period is deemed appropriate the Federal Register (56 FR 31043) and so that the proposed change, if adopted, Airworthiness Directives; Boeing assessments began on September 1, can be implemented as soon as possible. 1991. Model 757 Series Airplanes Powered The Soybean Promotion and Research List of Subjects in 7 CFR Part 1220 by Pratt & Whitney Engines Rules and Regulations, 7 CFR part 1220, Administrative practice and AGENCY: Federal Aviation published in the Federal Register on procedure, Advertising, Agricultural Administration, DOT. July 2, 1992 (57 FR 29436), specify in research, Marketing agreements, ACTION: § 1220.312(b) that first purchasers and Notice of proposed rulemaking Soybeans and soybean products, (NPRM). producers responsible for remitting Reporting and recordkeeping assessments shall remit assessments and requirements. SUMMARY: This document proposes the reports on a monthly or quarterly basis For the reasons set forth in the supersedure of an existing airworthiness depending upon the State or region in directive (AD), applicable to certain which they are located. This proposed preamble, it is proposed that Title 7, part 1220 be amended as follows: Boeing Model 757 series airplanes, that rule would change the States or regions currently requires modification of the of Delaware, Louisiana, South Carolina, PART 1220—SOYBEAN PROMOTION, nacelle strut and wing structure. This Texas, Eastern Region, and the Western RESEARCH, AND CONSUMER action would reduce a certain Region from remitting and reporting INFORMATION compliance time in the existing AD. The assessments on a monthly basis to a actions specified by the proposed AD quarterly basis. Currently, 15 States and 1. The authority citation for 7 CFR are intended to prevent fatigue cracking 2 regions report on a monthly basis and part 1220 continues to read as follows: in primary strut structure and 14 States report on a quarterly basis. Authority: 7 U.S.C. 6301–6311. consequent reduced structural integrity The Board, in conjunction with the of the strut. This action is intended to affected States and regions, 2. In § 1220.312, the table in address the identified unsafe condition. recommended to AMS to change the paragraph (b) is revised to read as period for remitting and reporting follows: DATES: Comments must be received by assessments for the following States or * * * * * August 4, 2003. regions from a monthly basis to (b) * * * ADDRESSES: Submit comments in quarterly basis: Delaware, Louisiana, triplicate to the Federal Aviation South Carolina, Texas, Eastern Region, Monthly Quarterly Administration (FAA), Transport and the Western Region. Airplane Directorate, ANM–114, Arkansas ...... Alabama Attention: Rules Docket No. 2001–NM– This proposed rule would assist these Iowa ...... Delaware smaller soybean producing States and Kansas ...... Florida 370–AD, 1601 Lind Avenue, SW., regions (listed above) in reporting and Kentucky ...... Georgia Renton, Washington 98055–4056. remitting their assessments to the Board. Michigan ...... Illinois Comments may be inspected at this The Board has decided that the current Minnesota ...... Indiana location between 9 a.m. and 3 p.m., requirement to remit and report Missouri ...... Louisiana Monday through Friday, except Federal assessments on a monthly basis is no Mississippi ...... Maryland holidays. Comments may be submitted longer necessary given the minimal North Carolina ...... North Dakota via fax to (425) 227–1232. Comments number of first purchasers and total Tennessee ...... Nebraska may also be sent via the Internet using Wisconsin ...... New Jersey the following address: 9-anm- remitters from these smaller soybean Ohio producing States and regions. Allowing Oklahoma [email protected]. Comments sent these States and regions to become Pennsylvania via fax or the Internet must contain quarterly remitters would reduce their South Carolina ‘‘Docket No. 2001–NM–370–AD’’ in the administrative costs. It is estimated that South Dakota subject line and need not be submitted administrative costs would be reduced Texas in triplicate. Comments sent via the

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Internet as attached electronic files must Availability of NPRMs Explanation of Requirements of be formatted in Microsoft Word 97 for Any person may obtain a copy of this Proposed Rule Windows or ASCII text. NPRM by submitting a request to the Since an unsafe condition has been The service information referenced in FAA, Transport Airplane Directorate, identified that is likely to exist or the proposed rule may be obtained from ANM–114, Attention: Rules Docket No. develop on other products of this same Boeing Commercial Airplane Group, PO 2001–NM–370–AD, 1601 Lind Avenue, type design, the proposed AD would Box 3707, Seattle, Washington 98124– SW., Renton, Washington 98055–4056. supersede AD 2000–20–09 to continue 2207. This information may be Discussion to require modification of the nacelle examined at the FAA, Transport strut and wing structure. This new Airplane Directorate, 1601 Lind On September 28, 2000, the FAA action proposes to reduce a certain Avenue, SW., Renton, Washington. issued AD 2000–20–09, amendment 39– compliance time in the existing AD. The FOR FURTHER INFORMATION CONTACT: 11920 (65 FR 59703, October 6, 2000), actions would be required to be Dennis Stremick, Aerospace Engineer, applicable to certain Boeing Model 757 accomplished in accordance with the Airframe Branch, ANM–120S, FAA, series airplanes, that requires service bulletins described previously, Seattle Aircraft Certification Office, modification of the nacelle strut and and as discussed below. 1601 Lind Avenue, SW., Renton, wing structure. The requirements of that Washington 98055–4056; telephone AD are intended to prevent fatigue Difference Between This Proposed AD (425) 917–6450; fax (425) 917–6590. cracking in primary strut structure and and Service Bulletin 757–54–0036 SUPPLEMENTARY INFORMATION: consequent reduced structural integrity This proposed AD would add a grace of the strut. period of 2 years to the thresholds Comments Invited Actions Since Issuance of Previous Rule recommended in the service bulletin for Interested persons are invited to accomplishment of the modification of Since the issuance of AD 2000–20–09, participate in the making of the the upper link and wire support bracket the airplane manufacturer has done a proposed rule by submitting such of the strut, as specified in paragraph (d) new structural reassessment of the written data, views, or arguments as upper link of the strut of Boeing Model of this AD, as follows: Prior to the they may desire. Communications shall 757 series airplanes powered by Pratt & accumulation of 27,000 total flight identify the Rules Docket number and Whitney engines. This reassessment cycles (for Model 757–200 series be submitted in triplicate to the address indicates that certain design changes are airplanes) or 29,000 total flight cycles specified above. All communications needed on the upper link to ensure that (for Model 757–200PF series airplanes), received on or before the closing date fatigue cracking does not occur on the or within 2 years after the effective date for comments, specified above, will be primary strut structure before an of this AD, whichever is later. considered before taking action on the airplane reaches its design service Cost Impact proposed rule. The proposals contained objective of 20 years, or 50,000 flight There are approximately 317 in this action may be changed in light cycles. Analysis indicates that such of the comments received. cracking, if it were to occur, would grow airplanes of the affected design in the Submit comments using the following at a much greater rate than originally worldwide fleet. The FAA estimates that format: 278 airplanes of U.S. registry would be • expected. Fatigue cracking in primary Organize comments issue-by-issue. strut structure would result in reduced affected by this proposed AD. Since this For example, discuss a request to structural integrity of the strut. proposed AD would merely reduce the change the compliance time and a The compliance time for the compliance time for certain actions request to change the service bulletin modification of the upper link (Boeing required by AD 2000–20–09 (Service reference as two separate issues. Service Bulletin 757–54–0036, dated Bulletin 757–54–0036), it would add no • For each issue, state what specific May 14, 1998) required by paragraph (b) additional costs, and would require no change to the proposed AD is being of AD 2000–20–09, has been reduced additional work to be performed by requested. due to this new structural assessment. affected operators. The current costs • Include justification (e.g., reasons or associated with AD 2000–20–09 are data) for each request. Explanation of New Relevant Service reiterated in their entirety (as follows) Comments are specifically invited on Information for the convenience of affected the overall regulatory, economic, We have reviewed and approved operators: environmental, and energy aspects of Boeing Service Bulletin 757–54–0034, It will take approximately 800 work the proposed rule. All comments Revision 1, dated October 11, 2001. hours per airplane to accomplish the submitted will be available, both before (Boeing Service Bulletin 757–54–0034, required modification of the nacelle and after the closing date for comments, dated May 14, 1998, was referenced as strut and wing structure described in in the Rules Docket for examination by the appropriate source of service Boeing Service Bulletin 757–54–0034, at interested persons. A report information for the actions required by an average labor rate of $60 per work summarizing each FAA-public contact paragraph (a) of AD 2000–20–09.) We hour. Required parts will be provided at concerned with the substance of this find that the changes incorporated in no cost by the airplane manufacturer. proposal will be filed in the Rules Revision 1 of the service bulletin are not Based on these figures, the cost impact Docket. substantive, meaning that airplanes of this required modification on U.S. Commenters wishing the FAA to modified per the original issue of the operators is estimated to be $13,344,000, acknowledge receipt of their comments service bulletin are not subject to any or $48,000 per airplane. submitted in response to this action additional work under Revision 1 of the It will take approximately 26 work must submit a self-addressed, stamped service bulletin. Therefore, we have hours per airplane to accomplish the postcard on which the following added Revision 1 of the service bulletin actions described in Boeing Service statement is made: ‘‘Comments to as another source of service information Bulletin 757–54–0027, Revision 1, at an Docket Number 2001–NM–370–AD.’’ for the accomplishment of the average labor rate of $60 per work hour. The postcard will be date stamped and modification required by paragraph (a) Required parts will be provided at no returned to the commenter. of this AD. cost by the airplane manufacturer.

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Based on these figures, the cost impact Administrator, the Federal Aviation paragraph (a) of this AD; as specified in of these required actions on U.S. Administration proposes to amend part paragraph I.D., Table I, ‘‘Strut Improvement operators is estimated to be $433,680, or 39 of the Federal Aviation Regulations Bulletins,’’ on page 5 of Boeing Service $1,560 per airplane. (14 CFR part 39) as follows: Bulletin 757–54–0034, dated May 14, 1998; It will take approximately 90 work accomplish the actions specified in Boeing hours per airplane to accomplish the PART 39—AIRWORTHINESS Service Bulletin 757–54–0027, Revision 1, DIRECTIVES dated October 27, 1994; and Boeing Service actions described in Boeing Service Bulletin 757–54–0036, dated May 14, 1998, Bulletin 757–54–0036, at an average 1. The authority citation for part 39 as applicable, in accordance with those labor rate of $60 per work hour. continues to read as follows: service bulletins. Required parts will be provided at no cost by the airplane manufacturer. Authority: 49 U.S.C. 106(g), 40113, 44701. Repair Based on these figures, the cost impact § 39.13 [Amended] (c) If any damage to airplane structure is found during the accomplishment of the of these required actions on U.S. 2. Section 39.13 is amended by operators is estimated to be $1,501,200, modification required by paragraph (a) of this removing amendment 39–11920 (65 FR AD; and the service bulletin specifies to or $5,400 per airplane. 59703, October 6, 2000), and by adding The cost impact figures discussed contact Boeing for appropriate action: Prior a new airworthiness directive (AD), to above are based on assumptions that no to further flight, repair in accordance with a read as follows: method approved by the Manager, Seattle operator has yet accomplished any of Boeing: Docket 2001–NM–370–AD. Aircraft Certification Office (ACO), FAA; or the current or proposed requirements of in accordance with data meeting the type this AD action, and that no operator Supersedes AD 2000–20–09, Amendment 39–11920. certification basis of the airplane approved would accomplish those actions in the by a Boeing Company Designated Applicability: Model 757 series airplanes future if this AD were not adopted. The Engineering Representative (DER) who has powered by Pratt & Whitney engines, line cost impact figures discussed in AD been authorized by the Manager, Seattle numbers 1 through 735 inclusive, certificated ACO, to make such findings. For a repair rulemaking actions represent only the in any category. time necessary to perform the specific method to be approved by the Manager, Note 1: This AD applies to each airplane Seattle ACO, as required by this paragraph, actions actually required by the AD. identified in the preceding applicability These figures typically do not include the approval letter must specifically provision, regardless of whether it has been reference this AD. incidental costs, such as the time modified, altered, or repaired in the area required to gain access and close up, subject to the requirements of this AD. For New Requirements of this AD: planning time, or time necessitated by airplanes that have been modified, altered, or Modification other administrative actions. repaired so that the performance of the requirements of this AD is affected, the (d) Modify the nacelle strut (includes Regulatory Impact owner/operator must request approval for an replacing the upper link with a new, The regulations proposed herein alternative method of compliance in improved part and modifying the wire would not have a substantial direct accordance with paragraph (e) of this AD. support bracket attached to the upper link) in effect on the States, on the relationship The request should include an assessment of accordance with Boeing Service Bulletin the effect of the modification, alteration, or 757–54–0036, dated May 14, 1998, at the between the national Government and repair on the unsafe condition addressed by earlier of the times specified in paragraph the States, or on the distribution of this AD; and, if the unsafe condition has not (d)(1) or (d)(2) of this AD. power and responsibilities among the been eliminated, the request should include (1) Prior to or concurrently with various levels of government. Therefore, specific proposed actions to address it. accomplishment of the modification of the it is determined that this proposal Compliance: Required as indicated, unless nacelle strut and wing structure required by would not have federalism implications accomplished previously. paragraph (a) of this AD. under Executive Order 13132. To prevent fatigue cracking in primary (2) Prior to the accumulation of 27,000 For the reasons discussed above, I strut structure and consequent reduced total flight cycles (for Model 757–200 series certify that this proposed regulation (1) structural integrity of the strut, accomplish airplanes) or 29,000 total flight cycles (for is not a ‘‘significant regulatory action’’ the following: Model 757–200PF series airplanes), or within under Executive Order 12866; (2) is not 2 years after the effective date of this AD, Restatement of Requirements of AD 2000– whichever is later. a ‘‘significant rule’’ under the DOT 20–09: Regulatory Policies and Procedures (44 Alternative Methods of Compliance Modifications FR 11034, February 26, 1979); and (3) if (e) An alternative method of compliance or (a) Modify the nacelle strut and wing promulgated, will not have a significant adjustment of the compliance time that structure on both the left and right sides of economic impact, positive or negative, provides an acceptable level of safety may be the airplane, in accordance with Boeing used if approved by the Manager, Seattle on a substantial number of small entities Service Bulletin 757–54–0034, dated May 14, ACO. Operators shall submit their requests under the criteria of the Regulatory 1998; or Revision 1, dated October 11, 2001; through an appropriate FAA Principal Flexibility Act. A copy of the draft at the later of the times specified in Maintenance Inspector, who may add regulatory evaluation prepared for this paragraph (a)(1) or (a)(2) of this AD. comments and then send it to the Manager, (1) Prior to the accumulation of 37,500 action is contained in the Rules Docket. Seattle ACO. A copy of it may be obtained by total flight cycles, or within 20 years since contacting the Rules Docket at the the date of manufacture, whichever occurs Note 2: Information concerning the existence of approved alternative methods of location provided under the caption first. Use of the optional threshold formula described in paragraph I.D. of the service compliance with this AD, if any, may be ADDRESSES. bulletin is an acceptable alternative to the 20- obtained from the Seattle ACO. List of Subjects in 14 CFR Part 39 year threshold. (2) Within 3,000 flight cycles after Special Flight Permits Air transportation, Aircraft, Aviation November 13, 2000 (the effective date of AD (f) Special flight permits may be issued in safety, Safety. 2000–20–09, amendment 39–11920). accordance with sections 21.197 and 21.199 The Proposed Amendment (b) Except as provided by paragraph (d) of of the Federal Aviation Regulations (14 CFR this AD: Prior to or concurrently with the 21.197 and 21.199) to operate the airplane to Accordingly, pursuant to the accomplishment of the modification of the a location where the requirements of this AD authority delegated to me by the nacelle strut and wing structure required by can be accomplished.

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Issued in Renton, Washington, on June 12, holidays. Comments may be submitted Commenters wishing the FAA to 2003. via fax to (425) 227–1232. Comments acknowledge receipt of their comments Kalene C. Yanamura, may also be sent via the Internet using submitted in response to this action Acting Manager, Transport Airplane the following address: 9-anm- must submit a self-addressed, stamped Directorate, Aircraft Certification Service. [email protected]. Comments sent postcard on which the following [FR Doc. 03–15336 Filed 6–17–03; 8:45 am] via fax or the Internet must contain statement is made: ‘‘Comments to BILLING CODE 4910–13–P ‘‘Docket No. 2000–NM–408–AD’’ in the Docket Number 2000–NM–408–AD.’’ subject line and need not be submitted The postcard will be date stamped and in triplicate. Comments sent via the returned to the commenter. DEPARTMENT OF TRANSPORTATION Internet as attached electronic files must Availability of NPRMs be formatted in Microsoft Word 97 or Federal Aviation Administration 2000 or ASCII text. Any person may obtain a copy of this The service information referenced in NPRM by submitting a request to the 14 CFR Part 39 the proposed rule may be obtained from FAA, Transport Airplane Directorate, [Docket No. 2000–NM–408–AD] Learjet, Inc., One Learjet Way, Wichita, ANM–114, Attention: Rules Docket No. Kansas 67209–2942. This information 2000–NM–408–AD, 1601 Lind Avenue, RIN 2120–AA64 may be examined at the FAA, Transport SW., Renton, Washington 98055–4056. Airworthiness Directives; Learjet Airplane Directorate, 1601 Lind Discussion Avenue, SW., Renton, Washington. Model 60 Airplanes On June 28, 1995, the FAA issued FOR FURTHER INFORMATION CONTACT: airworthiness directive (AD) 95–14–09, AGENCY: Federal Aviation Jeffrey Janusz, Aerospace Engineer, Administration, DOT. amendment 39–9303 (60 FR 36984, July Systems and Propulsion Branch, ACE– 19, 1995), applicable to certain Learjet ACTION: Notice of proposed rulemaking 116W, FAA, Wichita Aircraft 60 airplanes, to require inspection to (NPRM). Certification Office, 1801 Airport Road, detect bends in or damage to the fuel Room 100, Mid-Continent Airport, SUMMARY: This document proposes the crossflow tube; inspection to determine Wichita, Kansas 67209; telephone (316) clearance between the fuel crossflow supersedure of an existing airworthiness 946–4148; fax (316) 946–4407. directive (AD), applicable to certain tube and the flight control cables; and SUPPLEMENTARY INFORMATION: Learjet Model 60 airplanes, that replacement or repair of the tube, if currently requires inspection to detect Comments Invited necessary. That action was prompted by reports of chafing of the fuel crossflow bends in or damage to the fuel crossflow Interested persons are invited to tube; inspection to determine clearance tube by flight control cables. The participate in the making of the requirements of that AD are intended to between the fuel crossflow tube and the proposed rule by submitting such flight control cables; and replacement or prevent chafing and consequent failure written data, views, or arguments as of the fuel crossflow tube due to repair of the tube, if necessary. This they may desire. Communications shall action would require a review of inadequate clearance between the tube identify the Rules Docket number and and the flight control cables, which airplane maintenance records or an be submitted in triplicate to the address inspection to determine if a fuel could result in loss of fuel from one fuel specified above. All communications tank during normal operating conditions crossflow tube having a certain part received on or before the closing date number is installed; and follow-on/ or loss of fuel from both main fuel tanks for comments, specified above, will be during fuel cross-feeding operations. corrective actions, as applicable. This considered before taking action on the action also would expand the proposed rule. The proposals contained Actions Since Issuance of Previous Rule applicability of the existing AD to in this action may be changed in light Since the issuance of that AD, the include additional airplanes. The of the comments received. manufacturer has implemented a design actions specified by the proposed AD Submit comments using the following change to adequately preclude chafing are intended to prevent chafing and format: or bending of the fuel crossflow tube. consequent failure of the fuel crossflow • Organize comments issue-by-issue. Although the minimum clearance tube due to inadequate clearance For example, discuss a request to required by AD 95–14–09 was adequate, between the tube and the flight control change the compliance time and a there was a possibility that the fuel cables, which could result in loss of fuel request to change the service bulletin crossflow tube could be installed from one fuel tank during normal reference as two separate issues. incorrectly due to installation variables, operating conditions or loss of fuel from • For each issue, state what specific including rotation of the fuel crossflow both main fuel tanks during fuel cross- change to the proposed AD is being tube. The design change calls for an feeding operations. This action is requested. increased minimum clearance and the intended to address the identified • Include justification (e.g., reasons or installation of a specific part number for unsafe condition. data) for each request. the fuel crossflow tube, which can be DATES: Comments must be received by Comments are specifically invited on installed in only one way. August 4, 2003. the overall regulatory, economic, ADDRESSES: Submit comments in environmental, and energy aspects of Explanation of New Service triplicate to the Federal Aviation the proposed rule. All comments Information Administration (FAA), Transport submitted will be available, both before The FAA has reviewed and approved Airplane Directorate, ANM–114, and after the closing date for comments, Bombardier Learjet 60 Alert Service Attention: Rules Docket No. 2000–NM– in the Rules Docket for examination by Bulletin SB A60–28–3, Revision 2, 408–AD, 1601 Lind Avenue, SW., interested persons. A report dated October 26, 1998. This service Renton, Washington 98055–4056. summarizing each FAA-public contact bulletin describes procedures for Comments may be inspected at this concerned with the substance of this inspecting the fuel crossflow tube for location between 9 a.m. and 3 p.m., proposal will be filed in the Rules damage (e.g., chafing and/or bends), Monday through Friday, except Federal Docket. measuring the clearance between the

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crossflow tube and flight control cables, the effective date of this proposed AD) Changes to 14 CFR Part 39/Effect on the and correcting incorrect clearance. For for accomplishment of the review of the Proposed AD certain airplanes, this service bulletin airplane maintenance records/ On July 10, 2002, the FAA issued a also describes procedures for replacing inspection would address the identified new version of 14 CFR part 39 (67 FR existing fuel crossflow tubes with new unsafe condition in a timely manner. 47997, July 22, 2002), which governs the • Alert Service Bulletin A60–28–3, fuel crossflow tubes. This service FAA’s airworthiness directive system. bulletin also adds certain airplanes to Revision 2, also recommends a The regulation now includes material the effectivity listing. compliance time of 600 flight hours to that relates to altered products, special We also have reviewed and approved replace the fuel crossflow tube, if Bombardier Learjet 60 Service Bulletin necessary. This proposed AD would flight permits, and alternative methods SB 60–28–4, Revision 2, dated August extend the compliance time to require of compliance (AMOC). Because we 22, 2001. For certain airplanes, this replacement of any fuel crossflow tube have now included this material in part service bulletin describes procedures for not having the correct part number, with 39, only the office authorized to approve replacing existing fuel crossflow tubes a new tube having the correct part AMOCs is identified in each individual with new fuel crossflow tubes, and number, within 90 days after the AD. Therefore paragraph (d) and Note 1 measuring the clearance between the proposed inspection. In developing an of AD 95–14–09 have not been included crossflow tube and flight control cables. appropriate compliance time for this in this proposed AD. Paragraph (c) of Accomplishment of the actions proposed AD, we considered not only AD 95–14–09 has been revised to only specified in these service bulletins is the manufacturer’s recommendation, identify the office authorized to approve intended to adequately address the but the degree of urgency associated AMOCs, and is identified as paragraph identified unsafe condition. with addressing the subject unsafe (f) in this proposed AD. Explanation of Requirements of condition, the average utilization of the Cost Impact affected fleet, and the time necessary to Proposed Rule perform the inspection. In light of all of There are approximately 145 Model Since an unsafe condition has been these factors, the FAA finds a longer 60 airplanes of the affected design in the identified that is likely to exist or compliance time for completing the worldwide fleet. The FAA estimates that develop on other products of this same proposed actions to be warranted, in 109 airplanes of U.S. registry would be type design, the proposed AD would that it represents an appropriate interval affected by this proposed AD. supersede AD 95–14–09 to require a of time allowable for affected airplanes It would take approximately 2 work review of maintenance records or an to continue to operate without hours per airplane to accomplish the inspection to determine if a fuel compromising safety. review of airplane maintenance records/ crossflow tube having a certain part • Bombardier Learjet 60 Service inspection proposed in this AD action, number is installed; and follow-on/ Bulletins SB A60–28–3, Revision 2, and at an average labor rate of $60 per work corrective actions, as applicable. Certain SB 60–28–4, Revision 2, specify that if hour. Based on these figures, the cost actions would be required to be the correct fuel crossflow tube part impact of the proposed requirements of accomplished in accordance with the number is installed and if the specified this AD on U.S. operators is estimated service bulletins described previously, minimum clearance does not exist to be $13,080, or $120 per airplane. except as discussed below. between the fuel crossflow tube and the The cost impact figures discussed flight control cables, the manufacturer above are based on assumptions that no Differences Between Proposed Rule and operator has yet accomplished any of Service Bulletins may be contacted for disposition. This proposed AD would require that the current or proposed requirements of Operators should note the following correction of any incorrect clearances be this AD action, and that no operator differences between the proposed AD accomplished per a method approved would accomplish those actions in the and the service bulletins: by the FAA. future if this AD were not adopted. The • Bombardier Learjet 60 Alert Service cost impact figures discussed in AD Bulletin SB A60–28–3, Revision 2, Clarification of Part Number for rulemaking actions represent only the recommends that the fuel crossflow tube Installation time necessary to perform the specific be inspected for bends and evidence of Operators should note that, in actions actually required by the AD. damage (e.g., contact with the flight Bombardier Learjet 60 Alert Service These figures typically do not include control cables). It also recommends that Bulletin SB A60–28–3, Revision 2, the incidental costs, such as the time the clearance between the fuel crossflow fuel crossflow tube to be installed in the required to gain access and close up, tube and flight control cables be airplane is incorrectly identified as part planning time, or time necessitated by measured to ensure that it is at least number (P/N) 6026020–001 in Figure 1, other administrative actions. 0.150 inch. This proposed AD would detail D; the correct P/N is 6026020– Regulatory Impact not require those inspections because 005. The FAA has been advised that the they pertain to the previous airplane manufacturer will issue a revision to The regulations proposed herein design. In lieu of the previously this alert service bulletin to correct the would not have a substantial direct described inspections for bends and error. effect on the States, on the relationship evidence of damage, this proposed AD between the national Government and would require a review of the airplane Changes to the Applicability of the the States, or on the distribution of maintenance records or an inspection to Existing AD power and responsibilities among the determine if a certain part number for This proposed AD would expand the various levels of government. Therefore, the fuel crossflow tube is installed. In applicability to include affected it is determined that this proposal addition, the proposed AD would airplanes having serial numbers 60–056 would not have federalism implications require measurement of the clearance through 60–145 inclusive, in addition to under Executive Order 13132. between the fuel crossflow tube and serial numbers 60–001 through 60–055 For the reasons discussed above, I flight control cables to ensure that it is inclusive identified in the existing AD. certify that this proposed regulation (1) at least 0.35 inch. We have determined All of these airplanes are subject to the is not a ‘‘significant regulatory action’’ that an interval of 25 flight hours (after identified unsafe condition of this AD. under Executive Order 12866; (2) is not

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a ‘‘significant rule’’ under the DOT AD, before further flight, measure the Issued in Renton, Washington, on June 12, Regulatory Policies and Procedures (44 clearance between the fuel crossflow tube 2003. FR 11034, February 26, 1979); and (3) if and the flight control cables to determine if Kalene C. Yanamura, promulgated, will not have a significant it is at least 0.35 inch, per paragraph 2.B.(8) Acting Manager, Transport Airplane economic impact, positive or negative, of the Accomplishment Instructions of Directorate, Aircraft Certification Service. Bombardier Learjet 60 Alert Service Bulletin on a substantial number of small entities SB A60–28–3, Revision 2, dated October 26, [FR Doc. 03–15339 Filed 6–17–03; 8:45 am] under the criteria of the Regulatory 1998. BILLING CODE 4910–13–P Flexibility Act. A copy of the draft (1) If the clearance is 0.35 inch or more, no regulatory evaluation prepared for this further action is required by this paragraph. action is contained in the Rules Docket. (2) If the clearance is less than 0.35 inch, DEPARTMENT OF TRANSPORTATION A copy of it may be obtained by before further flight, repair per a method contacting the Rules Docket at the approved by the Manager, Wichita Aircraft Federal Aviation Administration location provided under the caption Certification Office (ACO), FAA. 14 CFR Part 39 ADDRESSES. Part Replacement, Measurement, and Repair List of Subjects in 14 CFR Part 39 (c) For airplanes having serial numbers 60– [Docket No. 2002–NM–179–AD] 001 through 60–055: If P/N 6026020–005 is Air transportation, Aircraft, Aviation not found installed during the review or RIN 2120–AA64 safety, Safety. inspection required by paragraph (a) of this The Proposed Amendment AD, within 90 days after accomplishing the Airworthiness Directives; Airbus Model review or inspection, replace the existing fuel A310 Series Airplanes Accordingly, pursuant to the crossflow tube with a new fuel crossflow authority delegated to me by the tube having P/N 6026020–005, and measure AGENCY: Federal Aviation Administrator, the Federal Aviation the clearance between the newly installed Administration, DOT. Administration proposes to amend part fuel crossflow tube and the flight control cables, per paragraph 2.A. of the ACTION: Notice of proposed rulemaking 39 of the Federal Aviation Regulations (NPRM). (14 CFR part 39) as follows: Accomplishment Instructions of Bombardier Learjet 60 Service Bulletin SB 60–28–4, Revision 2, dated August 22, 2001. SUMMARY: This document proposes the PART 39—AIRWORTHINESS adoption of a new airworthiness DIRECTIVES (1) If the clearance is 0.35 inch or more, no further action is required by this paragraph. directive (AD) that is applicable to all 1. The authority citation for part 39 (2) If the clearance is less than 0.35 inch, Airbus Model A310 series airplanes. continues to read as follows: before further flight, repair per a method This proposal would require electrical approved by the Manager, Wichita ACO, conductivity testing to verify the correct Authority: 49 U.S.C. 106(g), 40113, 44701. FAA. heat treatment of the two half fittings § 39.13 [Amended] (d) For airplanes having serial numbers 60– holding the ejection jack for the ram air 056 through 60–145: If P/N 6026020–005 is 2. Section 39.13 is amended by turbine (RAT). This action is necessary not found installed during the review or to prevent decreased structural integrity removing amendment 39–9303 (60 FR inspection required by paragraph (a) of this 36984, July 19, 1995), and by adding a AD, within 90 days after accomplishing the of the two half fittings and loss of the new airworthiness directive (AD), to review or inspection, replace the existing fuel RAT during extension, which could read as follows: crossflow tube with a new fuel crossflow lead to reduced controllability of the airplane in the event of a dual engine Learjet: Docket 2000–NM–408–AD. tube having P/N 6026020–005, and measure Supersedes AD 95–14–09, Amendment the clearance between the newly installed failure, or in the event of loss of two or 39–9303. fuel crossflow tube and the flight control all hydraulic systems. This action is cables to determine if the clearance is at least Applicability: Model 60 airplanes, serial intended to address the identified 0.35 inch, per paragraph 2.B. of the unsafe condition. numbers 60–001 through 60–145 inclusive, Accomplishment Instructions of Bombardier certificated in any category. Learjet 60 Alert Service Bulletin SB 60–28– DATES: Comments must be received by Compliance: Required as indicated, unless 3, Revision 2, dated October 26, 1998. July 18, 2003. accomplished previously. (1) If the clearance is 0.35 inch or more, no ADDRESSES: Submit comments in To prevent chafing and consequent failure further action is required by this paragraph. of the fuel crossflow tube due to inadequate triplicate to the Federal Aviation (2) If the clearance is less than 0.35 inch, clearance between the tube and the flight Administration (FAA), Transport before further flight, repair per a method control cables, which could result in loss of Airplane Directorate, ANM–114, approved by the Manager, Wichita ACO, fuel from one fuel tank during normal Attention: Rules Docket No. 2002–NM– FAA. operating conditions or loss of fuel from both 179–AD, 1601 Lind Avenue, SW., main fuel tanks during fuel cross-feeding Note 1: Alert Service Bulletin SB A60–28– Renton, Washington 98055–4056. operations, accomplish the following: 3, Revision 2, Figure 1, detail D., incorrectly Comments may be inspected at this identifies the fuel crossflow tube to be Part Identification installed as P/N 6026020–001. The location between 9 a.m. and 3 p.m., (a) Within 25 flight hours after the effective manufacturer is aware of this error and plans Monday through Friday, except Federal date of this AD, inspect the fuel crossflow to correct the part number in the next holidays. Comments may be submitted tube to determine whether part number revision of the alert service bulletin. via fax to (425) 227–1232. Comments (P/N) 5026020–005 is installed. Instead of may also be sent via the Internet using inspecting the tube, a review of airplane Part Installation the following address: 9-anm- maintenance records is acceptable if the P/N (e) As of the effective date of this AD, only [email protected]. Comments sent of the tube can be positively determined from fuel crossflow tubes having P/N 6026020–005 via fax or the Internet must contain that review. shall be installed on any airplane. ‘‘Docket No. 2002–NM–179–AD’’ in the Clearance Measurement and Corrective Alternative Methods of Compliance subject line and need not be submitted Action (f) In accordance with 14 CFR 39.19, the in triplicate. Comments sent via the (b) For all airplanes: If P/N 6026020–005 is Manager, Wichita ACO, FAA, is authorized Internet as attached electronic files must found installed during the review or to approve alternative methods of be formatted in Microsoft Word 97 or inspection required by paragraph (a) of this compliance for this AD. 2000 or ASCII text.

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The service information referenced in FAA, Transport Airplane Directorate, DGAC, reviewed all available the proposed rule may be obtained from ANM–114, Attention: Rules Docket No. information, and determined that AD Airbus Industrie, 1 Rond Point Maurice 2002–NM–179–AD, 1601 Lind Avenue, action is necessary for products of this Bellonte, 31707 Blagnac Cedex, France. SW., Renton, Washington 98055–4056. type design that are certificated for This information may be examined at operation in the United States. Discussion the FAA, Transport Airplane Explanation of Requirements of Directorate, 1601 Lind Avenue, SW., The Direction Ge´ne´rale de l’Aviation Proposed Rule Renton, Washington. Civile (DGAC), which is the FOR FURTHER INFORMATION CONTACT: Tom airworthiness authority for France, Since an unsafe condition has been Groves, Aerospace Engineer, notified the FAA that an unsafe identified that is likely to exist or International Branch, ANM–116, FAA, condition may exist on all Airbus Model develop on other airplanes of the same Transport Airplane Directorate, 1601 A310 series airplanes. The DGAC type design registered in the United Lind Avenue, SW., Renton, Washington advises that an operator reported that States, the proposed AD would require 98055–4056; telephone (425) 227–1503; the two half fittings holding the ejection accomplishment of the actions specified fax (425) 227–1149. jack for the ram air turbine (RAT) were in the service bulletin described found cracked. Investigation showed SUPPLEMENTARY INFORMATION: previously, except as discussed below. that the cracks were due to stress Comments Invited corrosion. Conductivity testing revealed Differences Between Proposed Rule, the that the heat treatment of the half Foreign Airworthiness Directive, and Interested persons are invited to the Service Bulletin participate in the making of the fittings aluminum alloy was incorrect. proposed rule by submitting such Incorrect heat treatment of the half The proposed AD would differ from written data, views, or arguments as fittings decreased the material behavior the parallel French airworthiness they may desire. Communications shall against stress corrosion, and was directive in that it would require all identify the Rules Docket number and identified as the cause of the cracking. replacement half fittings to have be submitted in triplicate to the address This condition, if not corrected, could successfully passed the electrical specified above. All communications result in decreased structural integrity conductivity test per Airbus Service received on or before the closing date of the half fittings and loss of the RAT Bulletin A310–57A2084, including for comments, specified above, will be during extension, which could lead to Appendix 01, dated May 3, 2002. considered before taking action on the reduced controllability of the airplane Operators should note that the parallel proposed rule. The proposals contained in the event of a dual engine failure, or French airworthiness directive requires in this action may be changed in light in the event of loss of two or all that replacement half fittings have a of the comments received. hydraulic systems. certain part number and should either have been ordered after November 2001, Submit comments using the following Explanation of Relevant Service or have successfully passed the format: Information • Organize comments issue-by-issue. electrical conductivity test. The FAA For example, discuss a request to Airbus has issued Service Bulletin does not consider the ‘‘order date’’ as change the compliance time and a A310–57A2084, including Appendix 01, sufficient assurance that the request to change the service bulletin dated May 3, 2002, which describes replacement half fittings have the reference as two separate issues. procedures for a one-time electrical correct heat treatment. • For each issue, state what specific conductivity test of the half fittings, to Operators should also note that, change to the proposed AD is being check for the heat treatment status. The although the service bulletin specifies requested. service bulletin also describes reporting to Airbus the result of the • Include justification (e.g., reasons or procedures for a detailed inspection of inspections and any corrective actions, data) for each request. the half fittings for cracks or corrosion, the proposed AD does not include such Comments are specifically invited on if necessary. The service bulletin also a requirement. the overall regulatory, economic, describes procedures for replacement of Cost Impact environmental, and energy aspects of the half fittings. Accomplishment of the the proposed rule. All comments actions specified in the service bulletin The FAA estimates that 48 airplanes submitted will be available, both before is intended to adequately address the of U.S. registry would be affected by this and after the closing date for comments, identified unsafe condition. The DGAC proposed AD, that it would take in the Rules Docket for examination by classified this service bulletin as approximately 1 work hour per airplane interested persons. A report mandatory and issued French to accomplish the proposed actions, and summarizing each FAA-public contact airworthiness directive 2002–263(B), that the average labor rate is $60 per concerned with the substance of this dated May 15, 2002, in order to ensure work hour. Based on these figures, the proposal will be filed in the Rules the continued airworthiness of these cost impact of the proposed AD on U.S. Docket. airplanes in France. operators is estimated to be $2,880, or Commenters wishing the FAA to $60 per airplane. FAA’s Conclusions acknowledge receipt of their comments The cost impact figure discussed submitted in response to this action This airplane model is manufactured above is based on assumptions that no must submit a self-addressed, stamped in France and is type certificated for operator has yet accomplished any of postcard on which the following operation in the United States under the the proposed requirements of this AD statement is made: ‘‘Comments to provisions of section 21.29 of the action, and that no operator would Docket Number 2002–NM–179–AD.’’ Federal Aviation Regulations (14 CFR accomplish those actions in the future if The postcard will be date stamped and 21.29) and the applicable bilateral this AD were not adopted. The cost returned to the commenter. airworthiness agreement. Pursuant to impact figures discussed in AD this bilateral airworthiness agreement, rulemaking actions represent only the Availability of NPRMs the DGAC has kept the FAA informed time necessary to perform the specific Any person may obtain a copy of this of the situation described above. The actions actually required by the AD. NPRM by submitting a request to the FAA has examined the findings of the These figures typically do not include

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incidental costs, such as the time § 39.13 [Amended] passed the electrical conductivity test, per required to gain access and close up, 2. Section 39.13 is amended by the service bulletin. planning time, or time necessitated by adding the following new airworthiness Parts Installation other administrative actions. directive: (d) As of the effective date of this AD, no Changes to 14 CFR Part 39/Effect on the Airbus: Docket 2002–NM–179–AD. person shall install a half fitting having part Proposed AD Applicability: All Model A310 series number A5721023800000 that has not airplanes, certificated in any category. successfully passed the electrical On July 10, 2002, the FAA issued a Compliance: Required as indicated, unless conductivity test per the service bulletin, on new version of 14 CFR part 39 (67 FR accomplished previously. any airplane. 47997, July 22, 2002), which governs the To prevent decreased structural integrity of Alternative Methods of Compliance FAA’s airworthiness directives system. the two half fittings and loss of the ram air turbine (RAT) during extension, which could (e) In accordance with 14 CFR 39.19, the The regulation now includes material lead to reduced controllability of the airplane Manager, ANM–116, FAA, is authorized to that relates to altered products, special in the event of a dual engine failure, or in approve alternative methods of compliance flight permits, and alternative methods the event of loss of two or all hydraulic for this AD. of compliance. Because we have now systems, accomplish the following: Note 2: The subject of this AD is addressed included this material in part 39, only in French airworthiness directive 2002– Service Bulletin References the office authorized to approve AMOCs 263(B), dated May 15, 2002. is identified in each individual AD. (a) The following information pertains to the service bulletin referenced in this AD: Issued in Renton, Washington, on June 12, Regulatory Impact (1) The term ‘‘service bulletin,’’ as used in 2003. this AD, means the Accomplishment Kalene C. Yanamura, The regulations proposed herein Instructions of Airbus Service Bulletin A310– Acting Manager, Transport Airplane would not have a substantial direct 57A2084, including Appendix 01, dated May Directorate, Aircraft Certification Service. 3, 2002. effect on the States, on the relationship [FR Doc. 03–15335 Filed 6–17–03; 8:45 am] (2) Although the service bulletin between the national Government and BILLING CODE 4910–13–P the States, or on the distribution of referenced in this AD specifies to submit information to the manufacturer, this AD power and responsibilities among the does not include such a requirement. various levels of government. Therefore, DEPARTMENT OF TRANSPORTATION it is determined that this proposal Conductivity Test would not have federalism implications (b) Within 600 flight hours after the Federal Aviation Administration under Executive Order 13132. effective date of this AD, perform a one-time electrical conductivity test of the two half 14 CFR Part 39 For the reasons discussed above, I fittings holding the RAT ejection jack, to certify that this proposed regulation (1) verify correct heat treatment of the half [Docket No. 2001–NM–238–AD] is not a ‘‘significant regulatory action’’ fittings, per the service bulletin. under Executive Order 12866; (2) is not (1) If correct heat treatment of the two half RIN 2120–AA64 a ‘‘significant rule’’ under the DOT fittings is verified, no further action is Regulatory Policies and Procedures (44 required by this paragraph. Airworthiness Directives; Boeing FR 11034, February 26, 1979); and (3) if (2) If incorrect heat treatment of any half Model 747–100, 747–100B, 747–100B fitting is found by the test performed in SUD, 747–200B, 747–200F, 747–200C, promulgated, will not have a significant paragraph (b) of this AD, perform a detailed economic impact, positive or negative, inspection of the two half fittings for any 747–300, 747SR, and 747SP Series on a substantial number of small entities cracking or corrosion, per the service Airplanes under the criteria of the Regulatory bulletin. AGENCY: Federal Aviation Flexibility Act. A copy of the draft Note 1: For the purposes of this AD, a Administration, DOT. regulatory evaluation prepared for this detailed inspection is defined as: ‘‘An action is contained in the Rules Docket. intensive visual examination of a specific ACTION: Notice of proposed rulemaking A copy of it may be obtained by structural area, system, installation, or (NPRM). contacting the Rules Docket at the assembly to detect damage, failure, or SUMMARY: This document proposes the location provided under the caption irregularity. Available lighting is normally supplemented with a direct source of good adoption of a new airworthiness ADDRESSES. lighting at intensity deemed appropriate by directive (AD) that is applicable to all List of Subjects in 14 CFR Part 39 the inspector. Inspection aids such as mirror, Boeing Model 747–100, 747–100B, 747– magnifying lenses, etc., may be used. Surface 100B SUD, 747–200B, 747–200F, 747– Air transportation, Aircraft, Aviation cleaning and elaborate access procedures 200C, 747–300, 747SR, and 747SP series safety, Safety. may be required.’’ airplanes. This proposal would require The Proposed Amendment Corrective Action repetitive inspections for discrepancies (c) For any half fittings that require a of the structure near and common to the Accordingly, pursuant to the detailed inspection per paragraph (b)(2) of upper chord and splice fittings of the authority delegated to me by the this AD: Do the actions specified in rear spar of the wing, and repair if Administrator, the Federal Aviation paragraph (c)(1) or (c)(2) of this AD, as necessary. This proposal also would Administration proposes to amend part applicable, per the service bulletin. provide for an optional modification 39 of the Federal Aviation Regulations (1) If no cracking or corrosion is found: that, if accomplished, would terminate (14 CFR part 39) as follows: Within one year after the effective date of this the repetitive inspection requirement, AD, replace the two half fittings with half but would necessitate eventual post- PART 39—AIRWORTHINESS fittings having part number A5721023800000 modification inspections. This action is DIRECTIVES that have successfully passed the electrical conductivity test, per the service bulletin. necessary to find and fix fatigue cracking of structure near and common 1. The authority citation for part 39 (2) If any cracking or corrosion is found: Before further flight, replace the two half to the upper chord and splice fittings of continues to read as follows: fittings with half fittings having part number the rear spar of the wing, which could Authority: 49 U.S.C. 106(g), 40113, 44701. A5721023800000 that have successfully result in loss of structural integrity of

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the airplane. This action is intended to • Include justification (e.g., reasons or replacing cracked, corroded, or damaged address the identified unsafe condition. data) for each request. bolts with new improved bolts; DATES: Comments must be received by Comments are specifically invited on removing any installed repair bushings; August 4, 2003. the overall regulatory, economic, performing an open-hole high frequency ADDRESSES: Submit comments in environmental, and energy aspects of eddy current (HFEC) inspection for triplicate to the Federal Aviation the proposed rule. All comments cracking of the bolt holes; installing new Administration (FAA), Transport submitted will be available, both before bushings if necessary; reinstalling bolts Airplane Directorate, ANM–114, and after the closing date for comments, that are not cracked, corroded, or Attention: Rules Docket No. 2001–NM– in the Rules Docket for examination by damaged; torquing the nuts; performing 238–AD, 1601 Lind Avenue, SW., interested persons. A report a detailed inspection of the shim Renton, Washington 98055–4056. summarizing each FAA-public contact between the kick fitting and bulkhead Comments may be inspected at this concerned with the substance of this strap for cracking or migration; and location between 9 a.m. and 3 p.m., proposal will be filed in the Rules replacing the shim with a new shim if Monday through Friday, except Federal Docket. necessary. Accomplishment of the holidays. Comments may be submitted Commenters wishing the FAA to actions specified in the service bulletin via fax to (425) 227–1232. Comments acknowledge receipt of their comments is intended to adequately address the may also be sent via the Internet using submitted in response to this action identified unsafe condition. The service bulletin also describes the following address: 9-anm- must submit a self-addressed, stamped procedures for an optional modification, [email protected]. Comments sent postcard on which the following which involves removing installed via fax or the Internet must contain statement is made: ‘‘Comments to Docket Number 2001–NM–238–AD.’’ repair bushings, performing an open- ‘‘Docket No. 2001–NM–238–AD’’ in the hole HFEC inspection for cracking of the subject line and need not be submitted The postcard will be date stamped and returned to the commenter. bolt holes, repairing any cracking that is in triplicate. Comments sent via the found, oversizing bolt holes, and Internet as attached electronic files must Availability of NPRMs installing new improved bolts. be formatted in Microsoft Word 97 for Any person may obtain a copy of this Accomplishment of the optional Windows or ASCII text. NPRM by submitting a request to the modification eliminates the need for the The service information referenced in FAA, Transport Airplane Directorate, repetitive inspections described the proposed rule may be obtained from ANM–114, Attention: Rules Docket No. previously, but necessitates eventual Boeing Commercial Airplane Group, PO 2001–NM–238–AD, 1601 Lind Avenue, post-modification inspections. The post- Box 3707, Seattle, Washington 98124– SW., Renton, Washington 98055–4056. modification inspections involve 2207. This information may be procedures similar to those for the pre- Discussion examined at the FAA, Transport modification inspections, which were Airplane Directorate, 1601 Lind The FAA has received reports described previously. Avenue, SW., Renton, Washington. indicating that fatigue cracking has been FOR FURTHER INFORMATION CONTACT: found on the wing on several Boeing Explanation of Requirements of Tamara Anderson, Aerospace Engineer, Model 747–100 and 747–200B series Proposed Rule Airframe Branch, ANM–120S, FAA, airplanes. The cracking is adjacent and Since an unsafe condition has been Seattle Aircraft Certification Office, common to the upper chord and splice identified that is likely to exist or 1601 Lind Avenue, SW., Renton, fittings of the rear spar of the wing. develop on other products of this same Washington 98055–4056; telephone Such cracking, if not corrected, could type design, the proposed AD would (425) 917–6421; fax (425) 917–6590. result in loss of structural integrity of require accomplishment of the actions SUPPLEMENTARY INFORMATION: the airplane. specified in the service bulletin The subject area on Model 747–100B, described previously, except as Comments Invited 747–100B SUD, 747–200F, 747–200C, discussed below under the heading Interested persons are invited to 747–300, 747SR, and 747SP series ‘‘Differences Between Proposed Rule participate in the making of the airplanes is similar to that on the and Service Bulletin.’’ proposed rule by submitting such affected Model 747–100 and 747–200B Clarification of Credit for Actions written data, views, or arguments as series airplanes. Therefore, all of these Accomplished Previously they may desire. Communications shall airplanes may be subject to the same identify the Rules Docket number and unsafe condition. Flag Note 1 of the logic diagram in be submitted in triplicate to the address Figure 1 of Boeing Alert Service Bulletin Explanation of Relevant Service specified above. All communications 747–57A2314, Revision 1, specifies that, Information received on or before the closing date for certain fastener holes on certain for comments, specified above, will be The FAA has reviewed and approved airplanes, an inspection per Figure 4, considered before taking action on the Boeing Alert Service Bulletin 747– Step 14, of Boeing Service Bulletin 747– proposed rule. The proposals contained 57A2314, Revision 1, dated January 9, 57–2110 is considered acceptable for in this action may be changed in light 2003, which describes procedures for compliance with the initial inspection of the comments received. repetitive inspections for discrepancies specified in paragraph (a) of this Submit comments using the following of the structure near and common to the proposed AD. We have reviewed and format: upper chord and splice fittings of the approved Boeing Service Bulletin 747– • Organize comments issue-by-issue. rear spar of the wing, and repair if 57–2110, Revision 6, dated November For example, discuss a request to necessary. The inspection procedures 21, 1991; and Revision 7, dated April change the compliance time and a include removing existing bolts; 23, 1998; and have determined that request to change the service bulletin performing an ultrasonic or magnetic accomplishment of an initial inspection reference as two separate issues. particle inspection for cracking of before the effective date of this AD per • For each issue, state what specific removed H–11 bolts; performing a Figure 4, Step 14, of one of those change to the proposed AD is being detailed inspection of all other removed revisions of the service bulletin would requested. bolts for cracking, corrosion, or damage; provide an acceptable level of safety.

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We have also reviewed Boeing Service incidental costs, such as the time PART 39—AIRWORTHINESS Bulletin 747–57–2110, Revision 3, dated required to gain access and close up, DIRECTIVES February 19, 1987; Revision 4, dated planning time, or time necessitated by May 26, 1988; and Revision 5, dated other administrative actions. 1. The authority citation for part 39 October 26, 1989. We have determined Should an operator elect to continues to read as follows: that accomplishment of an initial accomplish the optional terminating Authority: 49 U.S.C. 106(g), 40113, 44701. inspection before the effective date of action that would be provided by this this AD per Figure 4, Step 9, of one of AD action, it would take approximately § 39.13 [Amended] those revisions of the service bulletin 22 work hours to accomplish it, at an 2. Section 39.13 is amended by would provide an acceptable level of average labor rate of $60 per work hour. adding the following new airworthiness safety. The first repeat inspection per The cost of required parts would be directive: paragraph (b) of this proposed AD approximately $10,700 per airplane. Boeing: Docket 2001–NM–238–AD. would be required to be accomplished Based on these figures, the cost impact Applicability: All Model 747–100, 747– at the applicable interval established in of the optional terminating action would 100B, 747–100B SUD, 747–200B, 747–200F, paragraph (b) of this proposed AD after be approximately $12,020 per airplane. 747–200C, 747–300, 747SR, and 747SP series the most recent inspection per Figure 4, If the optional terminating action airplanes; certificated in any category. Step 14, of Boeing Service Bulletin 747– provided by this AD action is Note 1: This AD applies to each airplane 57–2110, Revision 6 or 7; or Figure 4, accomplished, an eventual post- identified in the preceding applicability Step 9, of Boeing Service Bulletin 747– modification inspection would be provision, regardless of whether it has been 57–2110, Revision 3, 4, or 5. necessary. That inspection would take modified, altered, or repaired in the area approximately 8 work hours per subject to the requirements of this AD. For Differences Between Proposed Rule and airplanes that have been modified, altered, or airplane to accomplish, at an average Service Bulletin repaired so that the performance of the labor rate of $60 per work hour. Based requirements of this AD is affected, the Operators should note that, although on these figures, the cost impact of the owner/operator must request approval for an the service bulletin specifies that the post modification inspections would be alternative method of compliance in manufacturer may be contacted for approximately $480 per airplane, per accordance with paragraph (k) of this AD. disposition of certain repair conditions, inspection cycle. The request should include an assessment of this proposal would require the repair of the effect of the modification, alteration, or those conditions to be accomplished per Regulatory Impact repair on the unsafe condition addressed by a method approved by the FAA, or per The regulations proposed herein this AD; and, if the unsafe condition has not data meeting the type certification basis would not have a substantial direct been eliminated, the request should include of the airplane approved by a Boeing effect on the States, on the relationship specific proposed actions to address it. Company Designated Engineering between the national Government and Compliance: Required as indicated, unless Representative who has been authorized the States, or on the distribution of accomplished previously. To find and fix fatigue cracking of structure by the FAA to make such findings. power and responsibilities among the near and common to the upper chord and Operators should also note that, various levels of government. Therefore, splice fittings of the rear spar of the wing, although Appendix B of Boeing Alert it is determined that this proposal which could result in loss of structural Service Bulletin 747–57A2314, Revision would not have federalism implications integrity of the airplane, accomplish the 1, describes procedures for reporting under Executive Order 13132. following: discrepancies found during an For the reasons discussed above, I Initial Inspections inspection, this proposed AD would not certify that this proposed regulation (1) require those actions. is not a ‘‘significant regulatory action’’ (a) Perform inspections for discrepancies of under Executive Order 12866; (2) is not the structure near and common to the upper Cost Impact chord and splice fittings of the rear spar of a ‘‘significant rule’’ under the DOT There are approximately 593 the wing, per Part 2 of the Accomplishment Regulatory Policies and Procedures (44 Instructions of Boeing Alert Service Bulletin airplanes of the affected design in the FR 11034, February 26, 1979); and (3) if 747–57A2314, Revision 1, dated January 9, worldwide fleet. The FAA estimates that promulgated, will not have a significant 2003. The inspection procedures include 176 airplanes of U.S. registry would be economic impact, positive or negative, removing existing bolts; performing an affected by this proposed AD. on a substantial number of small entities ultrasonic or magnetic particle inspection for It would take approximately 8 work under the criteria of the Regulatory cracking of removed H–11 bolts; performing hours per airplane to accomplish the Flexibility Act. A copy of the draft a detailed inspection of all other removed proposed inspection, at an average labor regulatory evaluation prepared for this bolts for cracking, corrosion, or damage; replacing cracked, corroded, or damaged rate of $60 per work hour. Based on action is contained in the Rules Docket. these figures, the cost impact of the bolts with new improved bolts; removing any A copy of it may be obtained by installed repair bushings; performing an proposed inspection on U.S. operators is contacting the Rules Docket at the open-hole high frequency eddy current estimated to be $84,480, or $480 per location provided under the caption (HFEC) inspection for cracking of the bolt airplane, per inspection cycle. ADDRESSES. holes; installing new bushings, if necessary; The cost impact figure discussed reinstalling bolts that are not cracked, above is based on assumptions that no List of Subjects in 14 CFR Part 39 corroded, or damaged; torquing the nuts; operator has yet accomplished any of Air transportation, Aircraft, Aviation performing a detailed inspection of the shim the proposed requirements of this AD safety, Safety. between the kick fitting and bulkhead strap action, and that no operator would for cracking or migration; and replacing the accomplish those actions in the future if The Proposed Amendment shim with a new shim if necessary, except as this proposed AD were not adopted. The Accordingly, pursuant to the provided by paragraph (h) of this AD. Do the initial inspection at the time specified in cost impact figures discussed in AD authority delegated to me by the paragraph (a)(1) or (a)(2) of this AD, rulemaking actions represent only the Administrator, the Federal Aviation whichever is later. time necessary to perform the specific Administration proposes to amend part (1) Inspect at the earlier of the applicable actions actually required by the AD. 39 of the Federal Aviation Regulations times specified in the ‘‘Flights’’ and ‘‘Hours’’ These figures typically do not include (14 CFR part 39) as follows: columns under the heading ‘‘Initial

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Inspection Threshold’’ in Table 1 of Figure 1 columns under the heading ‘‘Post inspection accomplished before the effective of the service bulletin. Where the ‘‘Initial Modification Threshold’’ in Table 2 of Figure date of this AD per Figure 4, Step 9, of Inspection Threshold’’ column of Table 1 of 1 of Boeing Alert Service Bulletin 747– Boeing Service Bulletin 747–57–2110, Figure 1 of the service bulletin specifies 57A2314, Revision 1, dated January 9, 2003, Revision 3, dated February 19, 1987; ‘‘flights’’ and ‘‘hours,’’ for the purposes of perform a post-modification inspection per Revision 4, dated May 26, 1988; and Revision this paragraph the numbers in that column Part 5 of the Accomplishment Instructions of 5, dated October 26, 1989; is also considered are considered to be the airplane’s total flight Boeing Alert Service Bulletin 747–57A2314, acceptable, as applicable, for compliance cycles and total flight hours. Revision 1, dated January 9, 2003. The with the initial inspection required by (2) Inspect within 18 months after the inspection procedures include removing paragraph (a) of this AD. The first repeat effective date of this AD. existing bolts; performing a detailed inspection per paragraph (b) of this AD must Note 2: For the purposes of this AD, a inspection of removed bolts for cracking, be accomplished at the applicable interval detailed inspection is defined as: ‘‘An corrosion, or damage; replacing cracked, established in paragraph (b) of this AD after intensive visual examination of a specific corroded, or damaged bolts with new bolts; the most recent inspection per Figure 4, Step structural area, system, installation, or removing any installed repair bushings; 14, of Boeing Service Bulletin 747–57–2110, assembly to detect damage, failure, or performing an open-hole HFEC inspection for Revision 6 or 7; or Figure 4, Step 9, of Boeing irregularity. Available lighting is normally cracking of the bolt holes; installing new Service Bulletin 747–57–2110, Revision 3, 4, supplemented with a direct source of good bushings if necessary; reinstalling bolts that or 5. lighting at intensity deemed appropriate by are not cracked, corroded, or damaged; the inspector. Inspection aids such as mirror, torquing the nuts; performing a detailed Exception to Instructions in Service Bulletin magnifying lenses, etc., may be used. Surface inspection of the shim between the kick (h) Where Boeing Alert Service Bulletin cleaning and elaborate access procedures fitting and bulkhead strap for cracking or 747–57A2314, Revision 1, dated January 9, may be required.’’ migration; and replacing the shim with a new 2003, specifies to contact Boeing for shim if necessary; except as provided by appropriate action, before further flight, Repetitive Inspections paragraph (h) of this AD. Where the ‘‘Post repair per a method approved by the (b) Repeat the inspection required by Modification Inspection Threshold’’ column Manager, Seattle ACO, or per data meeting paragraph (a) of this AD at intervals not to of Table 2 of Figure 1 of the service bulletin the type certification basis of the airplane exceed the earlier of the times specified in specifies ‘‘flights’’ and ‘‘hours,’’ for the approved by a Boeing Company DER who has the ‘‘Flights’’ and ‘‘Hours’’ columns under purposes of this paragraph, the numbers in been authorized by the Manager, Seattle the heading ‘‘Repeat Inspection Intervals’’ in that column are considered to be the flight ACO, to make such findings. For a repair Table 1 of Figure 1 of Boeing Alert Service cycles and flight hours after accomplishment method to be approved, the approval must Bulletin 747–57A2314, Revision 1, dated of the modification specified in paragraph (d) specifically reference this AD. January 9, 2003, until paragraph (d) of this of this AD. (i) Although Appendix B of Boeing Alert AD is accomplished. Where the ‘‘Repeat (1) Repeat the inspection at intervals not to Service Bulletin 747–57A2314, Revision 1, Inspection Intervals’’ column of Table 1 of exceed the earlier of the times specified in dated January 9, 2003, refers to a reporting Figure 1 of the service bulletin specifies the ‘‘Flights’’ and ‘‘Hours’’ columns under requirement, such reporting is not required ‘‘flights’’ and ‘‘hours,’’ for the purposes of the heading ‘‘Post Modification Repeat by this AD. this paragraph, the figures in that column are Inspection Intervals’’ in Table 2 of Figure 1 considered to be the number of flight cycles of the service bulletin. Where the ‘‘Post Parts Installation and flight hours from the time of the most Modification Repeat Inspection Intervals’’ (j) Except as provided by paragraphs (a) recent inspection per paragraph (a) or (b) of column of Table 2 of Figure 1 of the service and (b) of this AD, as of the effective date of this AD, except as provided by paragraph (g) bulletin specifies ‘‘flights’’ and ‘‘hours,’’ for this AD, no person may install any alloy steel of this AD. the purposes of this paragraph, the numbers bolt in any location specified in this AD on in that column are considered to be the flight Repair any airplane listed in the applicability of this cycles and flight hours since the most recent AD. (c) If any cracking is found during any inspection per paragraph (e) or (e)(1) of this inspection required by paragraph (a) or (b) of AD. Alternative Methods of Compliance this AD, before further flight, repair per the (2) If any cracking is found during any (k) An alternative method of compliance or Accomplishment Instructions of Boeing Alert inspection required by paragraph (e) or (e)(1) adjustment of the compliance time that Service Bulletin 747–57A2314, Revision 1, of this AD, before further flight, repair per the provides an acceptable level of safety may be dated January 9, 2003, except as provided by Accomplishment Instructions of Boeing Alert used if approved by the Manager, Seattle paragraph (h) of this AD. Service Bulletin 747–57A2314, Revision 1, ACO. Operators shall submit their requests dated January 9, 2003, except as provided by Optional Modification through an appropriate FAA Principal paragraph (h) of this AD. Maintenance Inspector, who may add (d) Accomplishment of the modification Actions Accomplished Per Previous Issue of comments and then send it to the Manager, specified in Part 4 of the Accomplishment Service Bulletin Seattle ACO. Instructions of Boeing Alert Service Bulletin Note 3: Information concerning the 747–57A2314, Revision 1, dated January 9, (f) Inspections, repairs, or modifications existence of approved alternative methods of 2003, constitutes terminating action for the accomplished before the effective date of this compliance with this AD, if any, may be initial inspections required by paragraph (a) AD per Boeing Alert Service Bulletin 747– obtained from the Seattle ACO. of this AD and the repetitive inspections 57A2314, including Appendix A and B, required by paragraph (b) of this AD, dated June 28, 2001, are considered Special Flight Permits provided that the repetitive post- acceptable for compliance with the modification inspections required by corresponding action specified in this AD, (l) Special flight permits may be issued in paragraph (e) of this AD are initiated at the except as provided by paragraph (h) of this accordance with sections 21.197 and 21.199 applicable time. The modification procedures AD. of the Federal Aviation Regulations (14 CFR include removing installed repair bushings, (g) As specified in Flag Note 1 of the logic 21.197 and 21.199) to operate the airplane to performing an open-hole HFEC inspection for diagram in Figure 1 of Boeing Alert Service a location where the requirements of this AD cracking of the bolt holes, repairing any Bulletin 747–57A2314, Revision 1, dated can be accomplished. cracking that is found, oversizing bolt holes, January 9, 2003: An inspection accomplished Issued in Renton, Washington, on June 11, and installing new improved bolts. before the effective date of this AD per Figure 2003. 4, Step 14, of Boeing Service Bulletin 747– Ali Bahrami, Post-Modification Inspections 57–2110, Revision 6, dated November 21, (e) For airplanes on which the optional 1991; or Revision 7, dated April 23, 1998; is Acting Manager, Transport Airplane modification specified in paragraph (d) of considered acceptable, as applicable, for Directorate, Aircraft Certification Service. this AD is accomplished: At the earlier of the compliance with the initial inspection [FR Doc. 03–15324 Filed 6–17–03; 8:45 am] times specified in the ‘‘Flights’’ and ‘‘Hours’’ required by paragraph (a) of this AD. An BILLING CODE 4910–13–P

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DEPARTMENT OF TRANSPORTATION [email protected]. Comments sent postcard on which the following via fax or the Internet must contain statement is made: ‘‘Comments to Federal Aviation Administration ‘‘Docket No. 2001–NM–181–AD’’ in the Docket Number 2001–NM–181–AD.’’ subject line and need not be submitted The postcard will be date stamped and 14 CFR Part 39 in triplicate. Comments sent via the returned to the commenter. [Docket No. 2001–NM–181–AD] Internet as attached electronic files must Availability of NPRMs be formatted in Microsoft Word 97 for RIN 2120–AA64 Windows or ASCII text. Any person may obtain a copy of this The service information referenced in NPRM by submitting a request to the Airworthiness Directives; Boeing the proposed rule may be obtained from FAA, Transport Airplane Directorate, Model 747–200F and –200C Series Boeing Commercial Airplane Group, PO ANM–114, Attention: Rules Docket No. Airplanes Box 3707, Seattle, Washington 98124– 2001–NM–181–AD, 1601 Lind Avenue, AGENCY: Federal Aviation 2207. This information may be SW., Renton, Washington 98055–4056. Administration, DOT. examined at the FAA, Transport Discussion Airplane Directorate, 1601 Lind ACTION: Notice of proposed rulemaking On April 20, 1998, the FAA issued Avenue, SW., Renton, Washington. (NPRM). AD 98–09–17, amendment 39–10498 (63 FOR FURTHER INFORMATION CONTACT: Rick SUMMARY: This document proposes the FR 20311, April 24, 1998), applicable to Kawaguchi, Aerospace Engineer, all Boeing Model 747–200F and –200C supersedure of an existing airworthiness Airframe Branch, ANM–120S, FAA, directive (AD), applicable to all Boeing series airplanes, to require repetitive Seattle Aircraft Certification Office, inspections or a one-time inspection to Model 747–200F and –200C series 1601 Lind Avenue, SW., Renton, airplanes, that currently requires detect cracking of certain areas of the Washington 98055–4056; telephone upper deck floor beams, and corrective repetitive detailed inspections or a one- (425) 917–6434; fax (425) 917–6590. time open-hole high frequency eddy actions if necessary. That action was current inspection to detect cracking of SUPPLEMENTARY INFORMATION: prompted by reports indicating that certain areas of the upper deck floor Comments Invited fatigue cracks were found in the upper beams, and corrective actions if chord and web of upper deck floor Interested persons are invited to necessary. This action would add new beams. The requirements of that AD are participate in the making of the one-time inspections for cracking of the intended to prevent such fatigue proposed rule by submitting such web, upper chord, and strap of the cracking and the resultant failure of written data, views, or arguments as upper deck floor beams. This action also such floor beams. Failure of the floor they may desire. Communications shall would add a requirement to modify or beam could result in damage to critical identify the Rules Docket number and repair the upper deck floor beams, as flight control cables and wire bundles be submitted in triplicate to the address applicable, which would eventually that pass through the floor beam, and specified above. All communications necessitate accomplishment of new consequent loss of controllability of the received on or before the closing date repetitive inspections for cracking of the airplane. Failure of the floor beam also for comments, specified above, will be upper deck floor beams. This action is could result in the failure of the considered before taking action on the necessary to prevent fatigue cracks in adjacent fuselage frames and skin, and proposed rule. The proposals contained the upper chord and web of upper deck consequent rapid decompression of the in this action may be changed in light floor beams and the resultant failure of airplane. of the comments received. such floor beams. Failure of a floor In the preamble to AD 98–09–17, we Submit comments using the following beam could result in damage to critical specify that the actions required by that format: flight control cables and wire bundles AD are considered ‘‘interim action’’ and • Organize comments issue-by-issue. that pass through the floor beam, and that the manufacturer was developing a For example, discuss a request to consequent loss of controllability of the preventive modification to address the change the compliance time and a airplane. Failure of the floor beam also unsafe condition. We indicated that we request to change the service bulletin could result in the failure of the might consider further rulemaking reference as two separate issues. adjacent fuselage frames and skin, and action once the modification was • For each issue, state what specific consequent rapid decompression of the developed, approved, and available. change to the proposed AD is being airplane. This action is intended to Though the manufacturer now has requested. address the identified unsafe developed such a modification, we have • Include justification (e.g., reasons or conditions. determined that it does not provide an data) for each request. adequate level of safety, as explained DATES: Comments must be received by Comments are specifically invited on below under the heading ‘‘Differences August 4, 2003. the overall regulatory, economic, Between Proposed AD and Service ADDRESSES: Submit comments in environmental, and energy aspects of Bulletins.’’ However, considering the triplicate to the Federal Aviation the proposed rule. All comments nature of the identified unsafe Administration (FAA), Transport submitted will be available, both before condition, we have determined that it is Airplane Directorate, ANM–114, and after the closing date for comments, necessary to proceed with rulemaking Attention: Rules Docket No. 2001–NM– in the Rules Docket for examination by action at this time to ensure the 181–AD, 1601 Lind Avenue, SW., interested persons. A report continued operating safety of the Renton, Washington 98055–4056. summarizing each FAA-public contact affected airplane fleet. This proposed Comments may be inspected at this concerned with the substance of this AD follows from that determination. location between 9 a.m. and 3 p.m., proposal will be filed in the Rules Monday through Friday, except Federal Docket. Explanation of Relevant Service holidays. Comments may be submitted Commenters wishing the FAA to Information via fax to (425) 227–1232. Comments acknowledge receipt of their comments We have reviewed and approved may also be sent via the Internet using submitted in response to this action Boeing Alert Service Bulletin 747– the following address: 9-anm- must submit a self-addressed, stamped 53A2429, dated March 22, 2001. That

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service bulletin describes procedures for Bulletin 747–53A2429 and Boeing U.S. registry would be affected by this a one-time detailed inspection for Service Bulletin 747–53A2420, Revision proposed AD. cracking of the web, upper chord, and 1, except as discussed below. For airplanes on which the repetitive strap of certain upper deck floor beams; detailed inspection that is currently Differences Between Proposed AD and and an open-hole high frequency eddy required by AD 98–09–17 is Service Bulletins current (HFEC) inspection for cracking accomplished, that inspection takes of the fastener holes of the web and Operators should note that, although approximately 1 work hour per airplane, upper chord. The service bulletin also Boeing Service Bulletin 747–53A2420, at an average labor rate of $60 per work describes procedures for modifying the Revision 1, specifies that the hour. Based on these figures, the cost upper chord of the upper deck floor manufacturer may be contacted for impact of the currently required beams, if no cracking is found, and for disposition of certain repair conditions, detailed inspection is estimated to be installing a permanent repair if cracking this proposed AD would require the $60 per airplane, per inspection cycle. is found. The service bulletin repair of those conditions to be The HFEC inspection that is currently recommends new repetitive open-hole accomplished in accordance with a required by AD 98–09–17 takes HFEC or surface HFEC inspections of method that we have approved, or in approximately 6 work hours per the upper deck floor beams following accordance with data meeting the type airplane to accomplish, at an average such modification or permanent repair. certification basis of the airplane labor rate of $60 per work hour. Based However, the service bulletin does not approved by a Boeing Company on these figures, the cost impact of the contain instructions for such Designated Engineering Representative currently required actions on U.S. inspections. (DER) who we have authorized to make operators is estimated to be $8,280, or We also have reviewed and approved such findings. $360 per airplane. Boeing Service Bulletin 747–53A2420, The new one-time detailed and HFEC Operators should note that, although inspections that are proposed in this AD Revision 1, dated January 7, 1999. (AD Boeing Alert Service Bulletin 747– 98–09–17 refers to Boeing Alert Service action would take approximately 7 work 53A2429 provides specific instructions Bulletin 747–53A2420, dated March 26, hours per airplane to accomplish, at an for modifying the upper chord of the 1998, as the appropriate source of average labor rate of $60 per work hour. upper deck floor beams or installing a service information for the inspections Based on these figures, the cost impact permanent repair, this proposed AD required by that AD.) In addition to of the new proposed inspection on U.S. would require a modification or procedures for inspections of the entire operators is estimated to be $9,660, or permanent repair be accomplished in area subject to inspections per AD 98– $420 per airplane. accordance with a method that we have 09–17, Boeing Service Bulletin 747– For airplanes subject to the approved, or in accordance with data 53A2420, Revision 1, describes modification that is proposed in this AD meeting the type certification basis of procedures for time-limited repairs of action, it would take approximately 172 certain crack configurations in the the airplane approved by a Boeing work hours per airplane to accomplish, upper deck floor beams. These time- Company DER who we have authorized at an average labor rate of $60 per work limited repairs involve removing the to make such findings. We have hour. Required parts would cost existing strap; performing HFEC determined that the modification and approximately $4,959 per airplane. inspections of the chord, web, and permanent repair procedures specified Based on these figures, the cost impact angle, as applicable; stop-drilling in Boeing Alert Service Bulletin 747– of the proposed modification is cracks; trimming the angle and 53A2429 do not provide an adequate estimated to be $15,279 per airplane. machining the vertical leg of the chord, level of safety. This determination is For airplanes subject to the repair that if necessary; and installing a new strap. based on two reports that we recently is proposed in this AD action, it would received, which indicate that cracks take approximately 172 work hours per Explanation of Requirements of have been found on airplanes that had airplane to accomplish, at an average Proposed Rule a modification similar to that specified labor rate of $60 per work hour. Since an unsafe condition has been in Boeing Alert Service Bulletin 747– Required parts would cost identified that is likely to exist or 53A2429. Boeing concurs with our approximately $21,646 to $21,857 per develop on other products of this same determination and intends to revise that airplane. Based on these figures, the cost type design, the proposed AD would service bulletin in the future to include impact of the proposed repair is supersede AD 98–09–17 to continue to new modification and permanent repair estimated to be $31,966 to $32,177 per require repetitive detailed inspections procedures. Once we have reviewed the airplane. or a one-time open-hole HFEC revised service bulletin, we may The follow-on repetitive inspections inspection to detect cracking of certain consider approving it as an alternative that are proposed in this AD action areas of the upper deck floor beams, and method of compliance to allow the would take approximately 6 work hours corrective actions if necessary. The modification or permanent repair to be per airplane to accomplish, at an proposed AD would add a requirement accomplished per that service bulletin. average labor rate of $60 per work hour. for new one-time detailed and open- Explanation of Change Made To Based on these figures, the cost impact hole HFEC inspections for cracking of Existing Requirements of the new proposed follow-on the web, upper chord, and strap of inspections on U.S. operators is upper deck floor beams. The proposed We have changed all references to a estimated to be $8,280, or $360 per AD also would require modification or ‘‘detailed visual inspection’’ in the airplane, per inspection cycle. permanent repair of the upper deck existing AD to ‘‘detailed inspection’’ in The cost impact figures discussed floor beams, as applicable, which would this action. Note 3 of this proposed AD above are based on assumptions that no eventually necessitate new repetitive defines such an inspection. operator has yet accomplished any of open-hole HFEC or surface HFEC the proposed requirements of this AD Cost Impact inspections for cracking of the upper action, and that no operator would deck floor beams. The actions would be There are approximately 81 airplanes accomplish those actions in the future if required to be accomplished in of the affected design in the worldwide this proposed AD were not adopted. The accordance with Boeing Alert Service fleet. We estimate that 23 airplanes of cost impact figures discussed in AD

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rulemaking actions represent only the Note 1: This AD applies to each airplane through BS 440 inclusive, and the upper time necessary to perform the specific identified in the preceding applicability deck floor beams at BS 500 and BS 520, on actions actually required by the AD. provision, regardless of whether it has been the right and left sides of the airplane, in These figures typically do not include modified, altered, or repaired in the area accordance with paragraph (b)(1) or (b)(2) of subject to the requirements of this AD. For this AD. The inspections shall be incidental costs, such as the time airplanes that have been modified, altered, or accomplished in accordance with Boeing required to gain access and close up, repaired so that the performance of the Alert Service Bulletin 747–53A2420, dated planning time, or time necessitated by requirements of this AD is affected, the March 26, 1998; or Boeing Service Bulletin other administrative actions. owner/operator must request approval for an 747–53A2420, Revision 1, dated January 7, alternative method of compliance in 1999. Regulatory Impact accordance with paragraph (l)(1) of this AD. (1) Perform a detailed inspection to detect The regulations proposed herein The request should include an assessment of cracks in accordance with Figure 2 of the would not have a substantial direct the effect of the modification, alteration, or service bulletin. effect on the States, on the relationship repair on the unsafe condition addressed by (i) Repeat the detailed inspection thereafter between the national Government and this AD; and, if the unsafe condition has not at intervals not to exceed 25 flight cycles, been eliminated, the request should include until the requirements of paragraph (b)(1)(ii) the States, or on the distribution of specific proposed actions to address it. or (e) of this AD are accomplished. power and responsibilities among the Compliance: Required as indicated, unless (ii) Within 250 flight cycles after various levels of government. Therefore, accomplished previously. accomplishment of the initial detailed it is determined that this proposal To prevent reduced controllability of the inspection, accomplish paragraph (b)(2) of would not have federalism implications airplane and/or rapid decompression of the this AD. under Executive Order 13132. airplane due to fatigue cracking in the upper (2) Perform a one-time open hole HFEC For the reasons discussed above, I deck floor beams, accomplish the following: inspection to detect cracks in accordance certify that this proposed regulation (1) with Figure 3 of the service bulletin. Requirements of AD 98–09–17 is not a ‘‘significant regulatory action’’ Accomplishment of this action constitutes under Executive Order 12866; (2) is not Note 2: For the purposes of calculating the terminating action for the repetitive compliance threshold and repetitive interval inspection requirements of paragraph (b)(1)(i) a ‘‘significant rule’’ under the DOT of this AD. Regulatory Policies and Procedures (44 for the actions required by paragraphs (a) and (b) of this AD, ‘‘flight cycles’’ are considered Repair FR 11034, February 26, 1979); and (3) if to be flight cycles with a cabin pressure promulgated, will not have a significant differential greater than 2.0 pounds per (c) If any cracking is found during any economic impact, positive or negative, square inch (psi). inspection required by paragraphs (a) or (b) on a substantial number of small entities of this AD, prior to further flight, repair in under the criteria of the Regulatory Repetitive Inspections of Certain Upper Deck accordance with a method approved by the Flexibility Act. A copy of the draft Floor Beams Manager, Seattle Aircraft Certification Office (ACO), FAA. regulatory evaluation prepared for this (a) For airplanes that have accumulated action is contained in the Rules Docket. less than 18,000 total flight cycles as of May New Requirements of this AD A copy of it may be obtained by 11, 1998 (the effective date of AD 98–09–17, amendment 39–10498): Prior to the Note 3: For the purposes of this AD, a contacting the Rules Docket at the accumulation of 15,000 total flight cycles, or detailed inspection is defined as: ‘‘An location provided under the caption within 250 flight cycles after May 11, 1998, intensive visual examination of a specific ADDRESSES. whichever occurs later, inspect the upper structural area, system, installation, or assembly to detect damage, failure, or List of Subjects in 14 CFR Part 39 chord, web, and strap of the upper deck floor beams at body station (BS) 340 through BS irregularity. Available lighting is normally Air transportation, Aircraft, Aviation 440 inclusive, and the upper deck floor supplemented with a direct source of good safety, Safety. beams at BS 500 and BS 520, on the right and lighting at intensity deemed appropriate by left sides of the airplane, in accordance with the inspector. Inspection aids such as mirror, The Proposed Amendment paragraph (a)(1) or (a)(2) of this AD. The magnifying lenses, etc., may be used. Surface Accordingly, pursuant to the inspections shall be accomplished in cleaning and elaborate access procedures authority delegated to me by the accordance with Boeing Alert Service may be required.’’ Administrator, the Federal Aviation Bulletin 747–53A2420, dated March 26, 1998; or Boeing Service Bulletin 747– Adjustments to Compliance Time: Cabin Administration proposes to amend part 53A2420, Revision 1, dated January 7, 1999. Differential Pressure 39 of the Federal Aviation Regulations (1) Perform a detailed inspection to detect (d) For the purposes of calculating the (14 CFR part 39) as follows: cracks in accordance with Figure 2 of the compliance threshold and repetitive interval service bulletin. for the actions required by paragraphs (e), (h), PART 39—AIRWORTHINESS (i) Repeat the detailed inspection thereafter (i), and (j) of this AD: The number of flight DIRECTIVES at intervals not to exceed 25 flight cycles, cycles in which cabin differential pressure is until the requirements of paragraph (a)(1)(ii) at 2.0 psi or less need not be counted when 1. The authority citation for part 39 or (e) of this AD are accomplished. determining the number of flight cycles that continues to read as follows: (ii) Within 500 flight cycles after have occurred on the airplane, provided that Authority: 49 U.S.C. 106(g), 40113, 44701. accomplishment of the initial detailed flight cycles with momentary spikes in cabin inspection, accomplish paragraph (a)(2) of differential pressure above 2.0 psi are § 39.13 [Amended] this AD. included as full pressure cycles. For this 2. Section 39.13 is amended by (2) Perform a one-time open hole high provision to apply, all cabin pressure records removing amendment 39–10498 (63 FR frequency eddy current (HFEC) inspection to must be maintained for each airplane: No 20311, April 24, 1998), and by adding detect cracks in accordance with Figure 3 of fleet-averaging of cabin pressure is allowed. the service bulletin. Accomplishment of this a new airworthiness directive (AD), to action constitutes terminating action for the Detailed and Eddy Current Inspections of read as follows: repetitive inspection requirements of Certain Upper Deck Floor Beams Boeing: Docket 2001–NM–181–AD. paragraph (a)(1)(i) of this AD. (e) Within 5,000 flight cycles after Supersedes AD 98–09–17, Amendment (b) For airplanes that have accumulated accomplishing the most recent inspection 39–10498. 18,000 or more total flight cycles as of May required by paragraph (a) or (b) of this AD, Applicability: All Model 747–200F and 11, 1998: Within 25 flight cycles after May or within 1,000 flight cycles after the –200C series airplanes, certificated in any 11, 1998, inspect the upper chord, web, and effective date of this AD, whichever is later: category. strap of the upper deck floor beams at BS 340 Do paragraphs (e)(1) and (e)(2) of this AD, in

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accordance with the Accomplishment dated January 7, 1999; except, where the Repair Instructions of Boeing Alert Service Bulletin service bulletin specifies to contact Boeing (k) If any cracking is found during any 747–53A2429, dated March 22, 2001. for appropriate action, before further flight, inspection required by paragraph (j)(1) or Accomplishment of both paragraphs (e)(1) repair in accordance with a method approved (j)(2) of this AD: Before further flight, repair and (e)(2) of this AD constitutes terminating by the Manager, Seattle ACO, or in in accordance with a method approved by action for the repetitive inspection accordance with data meeting the type the Manager, Seattle ACO, or in accordance requirement of paragraph (a)(1)(i) or (b)(1)(i) certification basis of the airplane approved with data meeting the type certification basis of this AD, as applicable. by a Boeing Company DER who has been of the airplane approved by a Boeing (1) Do a one-time detailed inspection for authorized by the Manager, Seattle ACO, to Company DER who has been authorized by cracking of the web, upper chord, and strap make such findings. For a repair method to the Manager, Seattle ACO, to make such of the upper deck floor beams at BS 340 be approved, the approval must specifically findings. For a repair method to be approved, through BS 440 inclusive, BS 500, and BS reference this AD. Within 1,500 flight cycles the approval must specifically refer to this 520, on the right and left sides of the or 18 months after the installation of the AD. airplane, as specified in Figure 1 of the time-limited repair, whichever is first, do service bulletin. Alternative Methods of Compliance paragraph (h)(2) of this AD. (2) Do an open-hole high frequency eddy (2) Accomplish the permanent repair of the (l)(1) An alternative method of compliance current inspection for cracking of the fastener upper deck floor beams at the locations or adjustment of the compliance time that holes of the web and upper chord of the provides an acceptable level of safety may be upper deck floor beams at BS 340 through BS shown in Figures 4 and 5, as applicable, of Boeing Alert Service Bulletin 747–53A2429, used if approved by the Manager, Seattle 440 inclusive, BS 500, and BS 520, on the ACO. Operators shall submit their requests right and left sides of the airplane, as dated March 22, 2001, in accordance with a method approved by the Manager, Seattle through an appropriate FAA Principal specified in Figure 2 of the service bulletin. Maintenance Inspector, who may add ACO, or in accordance with data meeting the comments and then send it to the Manager, Compliance With Paragraphs (a) or (b) and type certification basis of the airplane Seattle ACO. (e) approved by a Boeing Company DER who has (2) Alternative methods of compliance, been authorized by the Manager, Seattle (f) Airplanes on which the inspections approved previously in accordance with AD required by paragraph (e) of this AD are ACO, to make such findings. For a repair 98–09–17, amendment 39–10498, are accomplished within the compliance time method to be approved, the approval must approved as alternative methods of specified in paragraph (a) or (b) of this AD, specifically refer to this AD. compliance with paragraphs (a), (b), and (c) as applicable, are not required to be Note 5: The permanent repair procedures of this AD. inspected in accordance with paragraph (a) specified in Boeing Alert Service Bulletin or (b) of this AD, as applicable. Note 6: Information concerning the 747–53A2429, dated March 22, 2001, do not existence of approved alternative methods of Modification of Upper Deck Floor Beams provide an adequate level of safety and are compliance with this AD, if any, may be not acceptable for compliance with obtained from the Seattle ACO. Note 4: The modification procedures paragraph (h)(2) of this AD. specified in Boeing Alert Service Bulletin Special Flight Permits 747–53A2429, dated March 22, 2001, do not Airplanes Modified or Repaired Previously provide an adequate level of safety and are (m) Special flight permits may be issued in (i) For airplanes on which a repair per not acceptable for compliance with accordance with sections 21.197 and 21.199 paragraph (c) of this AD or the modification paragraph (g) of this AD. Figure 3 of the of the Federal Aviation Regulations (14 CFR or permanent repair specified in Boeing Alert service bulletin is used only for identifying 21.197 and 21.199) to operate the airplane to Service Bulletin 747–53A2429, dated March the floor beams. a location where the requirements of this AD 22, 2001, was accomplished before the can be accomplished. (g) If no cracking is found during the effective date of this AD: Within 5,000 flight Issued in Renton, Washington, on June 11, inspections required by paragraph (e) of this cycles after installation of such modification 2003. AD, before further flight, except as provided or repair, as applicable, inspect per by paragraph (i) of this AD, modify the upper paragraph (e) of this AD, then do paragraph Ali Bahrami, chord of the upper deck floor beams at the (g) or (h) of this AD, as applicable. Acting Manager, Transport Airplane locations in Figure 3 of Boeing Alert Service Directorate, Aircraft Certification Service. Bulletin 747–53A2429, dated March 22, Repetitive Inspections After Modification or [FR Doc. 03–15325 Filed 6–17–03; 8:45 am] 2001, in accordance with a method approved Permanent Repair BILLING CODE 4910–13–P by the Manager, Seattle ACO, or in (j) Within 15,000 flight cycles after accordance with data meeting the type installation of the modification or permanent certification basis of the airplane approved repair in accordance with paragraph (g) or (h) DEPARTMENT OF TRANSPORTATION by a Boeing Company Designated of this AD, as applicable, do paragraph (j)(1) Engineering Representative (DER) who has or (j)(2) of this AD, in accordance with a been authorized by the Manager, Seattle Federal Aviation Administration method approved by the Manager, Seattle ACO, to make such findings. For a ACO. For an inspection method to be modification method to be approved, the approved, the approval letter must 14 CFR Part 39 approval must specifically reference this AD. specifically reference this AD. [Docket No. 2001–NM–328–AD] Repair of Upper Deck Floor Beams (1) Option 1: Do surface HFEC inspections RIN 2120–AA64 (h) If any crack is found during either along the lower edge of the upper chord of inspection required by paragraph (e) of this the upper deck floor beams at BS 340 through BS 440 inclusive, BS 500, and BS 520, on the Airworthiness Directives; Bombardier AD: Before further flight, except as provided Model CL–600–2B19 (Regional Jet by paragraph (i) of this AD, do paragraph right and left sides of the airplane. Repeat the (h)(1) or (h)(2) of this AD. surface HFEC inspections at intervals not to Series 100 & 440) Airplanes exceed 1,000 flight cycles. (1) Accomplish all actions associated with AGENCY: (2) Option 2: Do open-hole HFEC Federal Aviation the time-limited repair, including removing Administration, DOT. the existing strap; performing HFEC inspections for cracking at fasteners common inspections of the chord, web, and angle, as to the upper chord, reinforcement straps, and ACTION: Notice of proposed rulemaking applicable; stop-drilling cracks; trimming the body frame of the upper deck floor beams at (NPRM). angle and machining the vertical leg of the BS 340 through BS 440 inclusive, BS 500, chord, as applicable; and installing a new and BS 520, on the right and left sides of the SUMMARY: This document proposes the strap. Do these actions in accordance with airplane. Repeat the open-hole HFEC adoption of a new airworthiness the Accomplishment Instructions of Boeing inspections at intervals not to exceed 3,000 directive (AD) that is applicable to Service Bulletin 747–53A2420, Revision 1, flight cycles. certain Bombardier Model CL–600–

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2B19 (Regional Jet Series 100 & 440) for comments, specified above, will be Explanation of Relevant Service airplanes. This proposal would require considered before taking action on the Information installing new vent tube assemblies for proposed rule. The proposals contained Bombardier has issued Service the main fuel tanks; and, on certain in this action may be changed in light Bulletin 601R–28–024, Revision ‘A’, airplanes, inspecting to measure the of the comments received. dated November 11, 1998, which clearance between the vent system Submit comments using the following describes procedures for installing new tubing and the applicable wing ribs, and format: vent tube assemblies for the main fuel corrective action if necessary. This tanks to prevent fuel escaping from the • Organize comments issue-by-issue. action is necessary to prevent a fire tank vent lines and spilling. The service For example, discuss a request to hazard due to fuel spillage. This action bulletin also describes procedures for is intended to address the identified change the compliance time and a inspecting certain airplanes to measure unsafe condition. request to change the service bulletin the clearance between the vent system DATES: Comments must be received by reference as two separate issues. tubing and the applicable wing ribs, and July 18, 2003. • For each issue, state what specific installing bracket assemblies on those ADDRESSES: Submit comments in change to the proposed AD is being airplanes to provide the proper triplicate to the Federal Aviation requested. clearance, if necessary. Administration (FAA), Transport • Include justification (e.g., reasons or Accomplishment of the actions Airplane Directorate, ANM–114, data) for each request. specified in the service bulletin is Attention: Rules Docket No. 2001–NM– intended to adequately address the 328–AD, 1601 Lind Avenue, SW., Comments are specifically invited on identified unsafe condition. TCCA Renton, Washington 98055–4056. the overall regulatory, economic, classified this service bulletin as Comments may be inspected at this environmental, and energy aspects of mandatory and issued Canadian location between 9 a.m. and 3 p.m., the proposed rule. All comments airworthiness directive CF–2001–31, Monday through Friday, except Federal submitted will be available, both before dated August 7, 2001, to ensure the holidays. Comments may be submitted and after the closing date for comments, continued airworthiness of these via fax to (425) 227–1232. Comments in the Rules Docket for examination by airplanes in Canada. interested persons. A report may also be sent via the Internet using FAA’s Conclusions the following address: 9–anm– summarizing each FAA-public contact [email protected]. Comments sent concerned with the substance of this This airplane model is manufactured via fax or the Internet must contain proposal will be filed in the Rules in Canada and is type certificated for ‘‘Docket No. 2001–NM–328–AD’’ in the Docket. operation in the United States under the provisions of section 21.29 of the subject line and need not be submitted Commenters wishing the FAA to Federal Aviation Regulations (14 CFR in triplicate. Comments sent via the acknowledge receipt of their comments 21.29) and the applicable bilateral Internet as attached electronic files must submitted in response to this action airworthiness agreement. Pursuant to be formatted in Microsoft Word 97 or must submit a self-addressed, stamped this bilateral airworthiness agreement, 2000 or ASCII text. postcard on which the following The service information referenced in TCCA has kept the FAA informed of the statement is made: ‘‘Comments to situation described above. The FAA has the proposed rule may be obtained from Docket Number 2001–NM–328–AD.’’ Bombardier, Inc., Canadair, Aerospace examined the findings of TCCA, The postcard will be date stamped and reviewed all available information, and Group, P.O. Box 6087, Station Centre- returned to the commenter. ville, Montreal, Quebec H3C 3G9, determined that AD action is necessary Canada. This information may be Availability of NPRMs for products of this type design that are examined at the FAA, Transport certificated for operation in the United Any person may obtain a copy of this Airplane Directorate, 1601 Lind States. NPRM by submitting a request to the Avenue, SW., Renton, Washington; or at Explanation of Requirements of FAA, Transport Airplane Directorate, the FAA, New York Aircraft Proposed Rule ANM–114, Attention: Rules Docket No. Certification Office, 10 Fifth Street, Since an unsafe condition has been Third Floor, Valley Stream, New York. 2001–NM–328–AD, 1601 Lind Avenue, SW., Renton, Washington 98055–4056. identified that is likely to exist or FOR FURTHER INFORMATION CONTACT: develop on other airplanes of the same James Delisio, Aerospace Engineer, Discussion type design registered in the United Airframe and Propulsion Branch, ANE– States, the proposed AD would require 171, FAA, New York Aircraft Transport Canada Civil Aviation accomplishment of the actions specified Certification Office, 10 Fifth Street, (TCCA), which is the airworthiness in the service bulletin described Third Floor, Valley Stream, New York authority for Canada, notified the FAA previously. 11581; telephone (516) 256–7521; fax that an unsafe condition may exist on (516) 568–2716. certain Bombardier Model CL–600– Changes to 14 CFR part 39/Effect on the Proposed AD SUPPLEMENTARY INFORMATION: 2B19 (Regional Jet Series 100 & 440) series airplanes. TCCA advises that fuel On July 10, 2002, the FAA issued a Comments Invited can enter the vent line system of the new version of 14 CFR part 39 (67 FR Interested persons are invited to main tank and get trapped. During 47997, July 22, 2002), which governs the participate in the making of the refueling, or ground and flight FAA’s airworthiness directives system. proposed rule by submitting such maneuvers, the fuel may spill from The regulation now includes material written data, views, or arguments as certain scoops onto the ground, run that relates to altered products, special they may desire. Communications shall along the lower wing skin, accumulate flight permits, and alternative methods identify the Rules Docket number and in the dry bay, and possibly drip onto of compliance. Because we have now be submitted in triplicate to the address the main landing gear and brakes. This included this material in part 39, only specified above. All communications fuel spillage, if not corrected, could the office authorized to approve AMOCs received on or before the closing date result in a fire hazard. is identified in each individual AD.

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Cost Impact regulatory evaluation prepared for this obvious damage, failure, or irregularity. This action is contained in the Rules Docket. level of inspection is made from within The FAA estimates that the proposed touching distance unless otherwise specified. installation would be required to be A copy of it may be obtained by contacting the Rules Docket at the A mirror may be necessary to enhance visual accomplished on 45 Model CL–600– access to all exposed surfaces in the 2B19 (Regional Jet Series 100 & 440) location provided under the caption inspection area. This level of inspection is airplanes of U.S. registry, that it would ADDRESSES. made under normally available lighting take approximately 15 work hours per List of Subjects in 14 CFR Part 39 conditions such as daylight, hangar lighting, flashlight, or droplight and may require airplane to accomplish the proposed Air transportation, Aircraft, Aviation installation, and that the average labor removal or opening of access panels or doors. safety, Safety. Stands, ladders, or platforms may be required rate is $60 per work hour. Required to gain proximity to the area being checked.’’ The Proposed Amendment parts would cost approximately $10,273 (1) If the clearance between the vent per airplane. Based on these figures, the Accordingly, pursuant to the system tubing and the applicable wing rib is cost impact of the proposed installation authority delegated to me by the 0.125 inch or more, no further action is on U.S. operators is estimated to be Administrator, the Federal Aviation required by this paragraph. $502,785, or $11,173 per airplane. Administration proposes to amend part (2) If the clearance between the vent The FAA estimates that the proposed 39 of the Federal Aviation Regulations system tubing and the applicable wing rib is inspection would be required to be (14 CFR part 39) as follows: less than 0.125 inch, prior to further flight, accomplished on 43 Model CL–600– install the bracket assemblies in accordance 2B19 (Regional Jet Series 100 & 440) PART 39—AIRWORTHINESS with paragraphs B.(8) through B.(10) of the airplanes of U.S. registry, that it would DIRECTIVES Accomplishment Instructions of the service bulletin. take approximately 1 work hour per airplane to accomplish the proposed 1. The authority citation for part 39 Alternative Methods of Compliance continues to read as follows: inspection, and that the average labor (c) In accordance with 14 CFR 39.19, the rate is $60 per work hour. Based on Authority: 49 U.S.C. 106(g), 40113, 44701. Manager, New York Aircraft Certification Office (ACO), FAA, is authorized to approve these figures, the cost impact of the § 39.13 [Amended] proposed inspection on U.S. operators is alternative methods of compliance for this estimated to be $2,580, or $60 per 2. Section 39.13 is amended by AD. airplane. adding the following new airworthiness Note 2: The subject of this AD is addressed The cost impact figures discussed directive: in Canadian airworthiness directive CF– above are based on assumptions that no Bombardier, Inc. (Formerly Canadair): 2001–31, dated August 7, 2001. operator has yet accomplished any of Docket 2001–NM–328–AD. Issued in Renton, Washington, on June 11, the proposed requirements of this AD Applicability: Model CL–600–2B19 2003. action, and that no operator would (Regional Jet Series 100 & 440) airplanes Kalene C. Yanamura, having serial numbers 7003 through 7067 accomplish those actions in the future if Acting Manager, Transport Airplane inclusive and 7069 through 7109 inclusive, this AD were not adopted. The cost Directorate, Aircraft Certification Service. certificated in any category; excluding those impact figures discussed in AD airplanes on which the actions specified in [FR Doc. 03–15326 Filed 6–17–03; 8:45 am] rulemaking actions represent only the Bombardier Service Bulletin 601R–28–024, BILLING CODE 4910–13–P time necessary to perform the specific dated May 21,1996, have been accomplished. actions actually required by the AD. (This applicability includes airplanes These figures typically do not include informally identified as ‘‘Series 200.’’) DEPARTMENT OF TRANSPORTATION incidental costs, such as the time Compliance: Required as indicated, unless required to gain access and close up, accomplished previously. Federal Aviation Administration planning time, or time necessitated by To prevent a fire hazard due to fuel other administrative actions. spillage, accomplish the following: 14 CFR Part 39 Installation Regulatory Impact [Docket No. 2001–NM–246–AD] (a) Within 180 days after the effective date The regulations proposed herein of this AD, install new vent tube assemblies RIN 2120–AA64 would not have a substantial direct for the main fuel tanks, per Part A of effect on the States, on the relationship paragraph 2.B. of the Accomplishment Airworthiness Directives; Boeing between the national Government and Instructions of Bombardier Service Bulletin Model 737–200, –200C, –300, –400, and the States, or on the distribution of 601R–28–024, Revision ‘A’, dated November –500 Series Airplanes 11, 1998. power and responsibilities among the AGENCY: Federal Aviation various levels of government. Therefore, Inspection and Corrective Action Administration, DOT. it is determined that this proposal (b) For airplanes having serial numbers ACTION: Notice of proposed rulemaking would not have federalism implications 7003 through 7035 inclusive, and 7048 (NPRM). under Executive Order 13132. through 7057 inclusive: Before further flight For the reasons discussed above, I after installing the vent tube assemblies as SUMMARY: This document proposes the certify that this proposed regulation: (1) required by paragraph (a) of this AD, perform adoption of a new airworthiness Is not a ‘‘significant regulatory action’’ a general visual inspection to measure the directive (AD) that is applicable to under Executive Order 12866; (2) is not clearance between the vent system tubing certain Boeing Model 737–200, –200C, a ‘‘significant rule’’ under the DOT and the applicable wing rib, per Part B of –300, –400, and –500 series airplanes. paragraph 2.B. of the Accomplishment Regulatory Policies and Procedures (44 Instructions of Bombardier Service Bulletin This proposal would require repetitive FR 11034, February 26, 1979); and (3) if 601R–28–024, Revision ‘A’, dated November inspections to find fatigue cracking of promulgated, will not have a significant 11, 1998. certain upper and lower skin panels of economic impact, positive or negative, Note 1: For the purposes of this AD, a the fuselage, and follow-on and on a substantial number of small entities general visual inspection is defined as: ‘‘A corrective actions, if necessary. This under the criteria of the Regulatory visual examination of an interior or exterior proposal also includes terminating Flexibility Act. A copy of the draft area, installation, or assembly to detect action for the repetitive inspections of

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certain modified or repaired areas only. • Organize comments issue-by-issue. Related Rulemaking This action is necessary to find and fix For example, discuss a request to fatigue cracking of the skin panels, change the compliance time and a This proposed AD is related to AD which could result in sudden fracture request to change the service bulletin 2002–07–08, amendment 39–12702 (67 and failure of the skin panels of the reference as two separate issues. FR 17917, April 12, 2002). That AD fuselage, and consequent rapid • For each issue, state what specific references Boeing Service Bulletin 737– decompression of the airplane. This change to the proposed AD is being 53A1177, Revision 6, dated May 31, action is intended to address the requested. 2001, as the appropriate source of service information for accomplishment identified unsafe condition. • Include justification (e.g., reasons or of the specified actions. (The AD also data) for each request. DATES: Comments must be received by referenced, for accomplishment of August 4, 2003. Comments are specifically invited on certain actions, Boeing Alert Service the overall regulatory, economic, ADDRESSES: Submit comments in Bulletin 737–53A1177, Revision 1, triplicate to the Federal Aviation environmental, and energy aspects of dated September 19, 1996; Revision 2, Administration (FAA), Transport the proposed rule. All comments dated July 24, 1997; Revision 3, dated Airplane Directorate, ANM–114, submitted will be available, both before September 18, 1997; Revision 4, dated Attention: Rules Docket No. 2001–NM– and after the closing date for comments, September 2, 1999; and Revision 5, 246–AD, 1601 Lind Avenue, SW., in the Rules Docket for examination by dated February 15, 2001.) That AD is Renton, Washington 98055–4056. interested persons. A report applicable to certain Boeing Model 737 Comments may be inspected at this summarizing each FAA-public contact series airplanes and requires repetitive location between 9 a.m. and 3 p.m., concerned with the substance of this inspections to find cracking of the lower Monday through Friday, except Federal proposal will be filed in the Rules skin at the lower row of fasteners in the holidays. Comments may be submitted Docket. lap joints of the fuselage, and repair of via fax to (425) 227–1232. Comments Commenters wishing the FAA to any cracking found. That AD also may also be sent via the Internet using acknowledge receipt of their comments requires modification of the fuselage lap the following address: 9-anm- submitted in response to this action joints at certain locations, which [email protected]. Comments sent must submit a self-addressed, stamped constitutes terminating action for via fax or the Internet must contain postcard on which the following repetitive inspections of the modified ‘‘Docket No. 2001–NM–246–AD’’ in the statement is made: ‘‘Comments to areas. Additionally, that AD requires subject line and need not be submitted Docket Number 2001–NM–246–AD.’’ replacement of a preventive in triplicate. Comments sent via the The postcard will be date stamped and modification with an improved Internet as attached electronic files must returned to the commenter. modification. be formatted in Microsoft Word 97 for Availability of NPRMs Windows or ASCII text. Explanation of Relevant Service Information The service information referenced in Any person may obtain a copy of this NPRM by submitting a request to the the proposed rule may be obtained from We have reviewed and approved Boeing Commercial Airplane Group, PO FAA, Transport Airplane Directorate, ANM–114, Attention: Rules Docket No. Boeing Alert Service Bulletin 737– Box 3707, Seattle, Washington 98124– 53A1210, Revision 1, including 2207. This information may be 2001–NM–246–AD, 1601 Lind Avenue, SW., Renton, Washington 98055–4056. Appendix A and Evaluation Form, examined at the FAA, Transport dated October 25, 2001. The service Airplane Directorate, 1601 Lind Discussion bulletin describes procedures for Avenue, SW., Renton, Washington. The FAA has received reports repetitive external detailed and eddy FOR FURTHER INFORMATION CONTACT: indicating that cracks were found along current inspections to find fatigue Duong Tran, Aerospace Engineer, the edges of the chem-milled pockets in cracking of the upper and lower skin Airframe Branch, ANM–120S, FAA, the upper skin at stringer S–12, and panels of the fuselage (crown area and Seattle Aircraft Certification Office, above the S–4, S–10, and S–14 lap lower lobe area) at stringer S–12, and 1601 Lind Avenue, SW., Renton, joints, on several Boeing Model 737 above the S–4, S–10, and S–14 lap Washington 98055–4056; telephone series airplanes. The cracks were up to joints, and repair of any cracking with (425) 917–6452; fax (425) 917–6590. 6 inches long and multiple adjacent either a permanent or time-limited SUPPLEMENTARY INFORMATION: bays were found to be cracked along the repair. same stringers on three of the airplanes. For airplanes on which a time-limited Comments Invited The airplanes had accumulated between repair is done, Part 4 of the service Interested persons are invited to 34,574 and 56,949 total flight cycles. bulletin describes procedures for a participate in the making of the Additionally, skin cracks up to 4 inches subsequent permanent repair within proposed rule by submitting such long located below the S–14 lap joint 10,000 flight cycles after installation of written data, views, or arguments as along the bonded skin doublers were the time-limited repair. Doing a they may desire. Communications shall reported on 25 other airplanes which permanent repair eliminates the need identify the Rules Docket number and had accumulated between 22,786 and for the repetitive inspections for the be submitted in triplicate to the address 80,113 total flight cycles. repaired area only. specified above. All communications Analysis by the manufacturer For Group 3, 5, 6, and 8 airplanes received on or before the closing date revealed that these cracks are caused by only, on which no cracking is found, for comments, specified above, will be fatigue due to high bending stresses at Part 5 of the service bulletin provides considered before taking action on the the edge of chem-milled pockets or procedures for a preventive proposed rule. The proposals contained bonded skin doublers. Such fatigue modification of the chem-milled pockets in this action may be changed in light cracking could result in sudden fracture in the upper skins at stringer S–12, of the comments received. and failure of the skin panels of the between body station (BS) 500D and BS Submit comments using the following fuselage, and consequent rapid 520, which would end the repetitive format: decompression of the airplane. inspections for the modified area only.

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The service bulletin also describes previously does not include the it is determined that this proposal procedures for repetitive follow-on inspection of the crown area (upper would not have federalism implications visual inspections for cracking of the lobe) for Group 7 airplanes, as specified under Executive Order 13132. lower lobe skins from S–15L to S–15R in paragraph (a) of this proposed AD, For the reasons discussed above, I between stations 360 and 1016 and in the manufacturer has advised that it certify that this proposed regulation (1) section 41; replacement of any loose currently is developing a new service is not a ‘‘significant regulatory action’’ fasteners with new fasteners; an internal bulletin to address those airplanes. under Executive Order 12866; (2) is not eddy current inspection of the skin, tear Once the FAA has reviewed and a ‘‘significant rule’’ under the DOT straps, and lap joint in each adjacent approved the service bulletin, we may Regulatory Policies and Procedures (44 bay for cracking; and repair of any consider additional rulemaking to FR 11034, February 26, 1979); and (3) if cracking found. mandate those inspections. promulgated, will not have a significant Accomplishment of the actions Cost Impact economic impact, positive or negative, specified in Service Bulletin 737– on a substantial number of small entities 53A1210, Revision 1, is intended to There are approximately 2,200 under the criteria of the Regulatory adequately address the identified unsafe airplanes of the affected design in the Flexibility Act. A copy of the draft condition. worldwide fleet. The FAA estimates that regulatory evaluation prepared for this 903 airplanes of U.S. registry would be action is contained in the Rules Docket. Explanation of Requirements of affected by this proposed AD. Proposed Rule A copy of it may be obtained by It would take approximately 94 work contacting the Rules Docket at the Since an unsafe condition has been hours per airplane to accomplish the location provided under the caption proposed inspections of the crown area, identified that is likely to exist or ADDRESSES. develop on other products of this same at an average labor rate of $60 per work type design, the proposed AD would hour. Based on these figures, the cost List of Subjects in 14 CFR Part 39 require accomplishment of the actions impact of these proposed inspections on Air transportation, Aircraft, Aviation specified in the service bulletin U.S. operators is estimated to be safety, Safety. described previously, except as $5,092,920, or $5,640 per airplane, per discussed below. inspection cycle. The Proposed Amendment It would take approximately 96 work Accordingly, pursuant to the Differences Between Proposed AD and hours per airplane to accomplish the authority delegated to me by the Service Bulletin 737–53A1210, Revision proposed inspections of the lower lobe Administrator, the Federal Aviation 1 area, at an average labor rate of $60 per Administration proposes to amend part The service bulletin specifies that the work hour. Based on these figures, the 39 of the Federal Aviation Regulations manufacturer may be contacted for cost impact of these proposed (14 CFR part 39) as follows: disposition of certain repair conditions, inspections on U.S. operators is but this proposed AD would require the estimated to be $5,201,280, or $5,760 PART 39—AIRWORTHINESS repair of those conditions to be done per per airplane, per inspection cycle. DIRECTIVES a method approved by the FAA, or per The cost impact figures discussed data meeting the type certification basis above are based on assumptions that no 1. The authority citation for part 39 of the airplane approved by a Boeing operator has yet accomplished any of continues to read as follows: Company Designated Engineering the proposed requirements of this AD Authority: 49 U.S.C. 106(g), 40113, 44701. Representative who has been authorized action, and that no operator would by the FAA to make such findings. accomplish those actions in the future if § 39.13 [Amended] The service bulletin recommends that, this proposed AD were not adopted. The 2. Section 39.13 is amended by after installation of a time-limited cost impact figures discussed in AD adding the following new airworthiness repair, an internal eddy current rulemaking actions represent only the directive: inspection should be done at the first time necessary to perform the specific Boeing: Docket 2001–NM–246–AD. ‘‘C–check’’ or within 4,000 flight cycles, actions actually required by the AD. whichever is last. Because ‘‘C–check’’ These figures typically do not include Applicability: Model 737–200, –200C, schedules vary among operators, such a –300, –400, and –500 series airplanes, as incidental costs, such as the time listed in Boeing Alert Service Bulletin 737– nonspecific interval would provide no required to gain access and close up, 53A1210, Revision 1, dated October 25, 2001; assurance that operators would do the planning time, or time necessitated by certificated in any category. inspection within the prescribed other administrative actions. Note 1: This AD applies to each airplane schedule. This proposed AD would Should an operator elect to install the identified in the preceding applicability require that the inspection be done preventive modification, it would take provision, regardless of whether it has been within 4,000 flight cycles after the approximately 108 work hours to modified, altered, or repaired in the area repair installation. We find that a 4,000- accomplish, at an average labor rate of subject to the requirements of this AD. For flight-cycle interval is appropriate for $60 per work hour. Based on these airplanes that have been modified, altered, or affected airplanes to continue to operate figures, the cost impact of the repaired so that the performance of the without compromising safety. preventive modification is estimated to requirements of this AD is affected, the Although the service bulletin be $6,480 per airplane. owner/operator must request approval for an alternative method of compliance in recommends that operators report Regulatory Impact accordance with paragraph (g) of this AD. inspection results to the manufacturer, The request should include an assessment of this proposed AD does not contain such The regulations proposed herein the effect of the modification, alteration, or a reporting requirement. would not have a substantial direct repair on the unsafe condition addressed by effect on the States, on the relationship this AD; and, if the unsafe condition has not Interim Action between the national Government and been eliminated, the request should include This is considered to be interim the States, or on the distribution of specific proposed actions to address it. action for Group 7 airplanes. Although power and responsibilities among the Compliance: Required as indicated, unless the service bulletin described various levels of government. Therefore, accomplished previously.

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To find and fix fatigue cracking of certain dated October 25, 2001. Where the service (3) Within 10,000 flight cycles after doing upper and lower skin panels of the fuselage, bulletin specifies to contact Boeing for repair the repair: Make the repair permanent per which could result in sudden fracture and instructions, before further flight, repair per Part 4 and Figure 20 of the Work Instructions failure of the skin panels and consequent a method approved by the Manager, Seattle of the service bulletin, which ends the rapid decompression of the airplane, Aircraft Certification Office (ACO), FAA; or repetitive inspections for the repaired area accomplish the following: per data meeting the type certification basis only. of the airplane approved by a Boeing External Detailed and Eddy Current Company Designated Engineering Credit for Actions Done per Previous Service Inspections Representative (DER) who has been Bulletin (a) For Groups 1 through 6 and Group 8 authorized by the Manager, Seattle ACO, to (f) Inspections, repairs, and preventive airplanes: Before the accumulation of 35,000 make such findings. For a repair method to modifications done before the effective date total flight cycles, or within 4,500 flight be approved by the Manager, Seattle ACO, as of this AD per Boeing Alert Service Bulletin cycles after the effective date of this AD, required by this paragraph, the approval 737–53A1210, dated December 14, 2000, are whichever is later, do external detailed and letter must specifically reference this AD. acceptable for compliance with the eddy current inspections of the crown area (1) For cracking of the crown area, do the corresponding actions required by this AD. skin panels of the fuselage for cracking, per repair specified in either paragraph (d)(1)(i) Alternative Methods of Compliance Part 1 and Figure 1 of the Work Instructions or (d)(1)(ii) of this AD. Installation of the lap of Boeing Alert Service Bulletin 737– joint repair specified in paragraph (g) of AD (g) An alternative method of compliance or 53A1210, Revision 1, including Appendix A 2002–07–08, amendment 39–12702, is adjustment of the compliance time that and excluding Evaluation Form, dated considered acceptable for compliance with provides an acceptable level of safety may be October 25, 2001. Repeat the inspections at the corresponding action specified in this used if approved by the Manager, Seattle least every 4,500 flight cycles until paragraph paragraph for the lap joint areas only. ACO. Operators shall submit their requests (c) or (d)(1)(ii) of this AD has been done, as (i) Do a time-limited repair per Part 4 of the through an appropriate FAA Principal applicable. Although paragraph 1.D. of the Work Instructions of the service bulletin, Maintenance Inspector, who may add service bulletin references a reporting then do the actions required by paragraph (e) comments and then send it to the Manager, requirement, such reporting is not required of this AD at the times specified in that Seattle ACO. by this AD. paragraph. Note 3: Information concerning the Note 2: For the purposes of this AD, a (ii) Do a permanent repair per Part 3 of the existence of approved alternative methods of detailed inspection is defined as: ‘‘An Work Instructions of the service bulletin. compliance with this AD, if any, may be intensive visual examination of a specific Installation of a permanent repair ends the obtained from the Seattle ACO. structural area, system, installation, or repetitive inspections required by paragraph assembly to detect damage, failure, or (a) of this AD for the repaired area only. Special Flight Permit irregularity. Available lighting is normally (2) For cracking of the lower lobe area and (h) Special flight permits may be issued in supplemented with a direct source of good Section 41, repair per Part 2 of the Work accordance with sections 21.197 and 21.199 lighting at intensity deemed appropriate by Instructions of the service bulletin. of the Federal Aviation Regulations (14 CFR the inspector. Inspection aids such as mirror, Accomplishment of this repair ends the 21.197 and 21.199) to operate the airplane to magnifying lenses, etc., may be used. Surface repetitive inspections required by paragraph a location where the requirements of this AD cleaning and elaborate access procedures (b) of this AD for the repaired area only. can be accomplished. may be required.’’ Follow-on and Corrective Actions Issued in Renton, Washington, on June 11, (b) For all airplanes: Before the 2003. accumulation of 40,000 total flight cycles, or (e) If a time-limited repair is done, as Ali Bahrami, within 4,500 flight cycles after the effective specified in paragraph (d)(1)(i) of this AD: Do date of this AD, whichever is later, do an the actions specified in paragraphs (e)(1), Acting Manager, Transport Airplane external detailed inspection of the lower lobe (e)(2), and (e)(3) of this AD, at the times Directorate, Aircraft Certification Service. area and section 41 of the fuselage for specified, per the Work Instructions of [FR Doc. 03–15327 Filed 6–17–03; 8:45 am] Boeing Alert Service Bulletin 737–53A1210, cracking, per Part 2 and Figure 2 of the Work BILLING CODE 4910–13–P Instructions of Boeing Alert Service Bulletin Revision 1, including Appendix A and 737–53A1210, Revision 1, including excluding Evaluation Form, dated October 25, 2001. Appendix A and excluding Evaluation Form, DEPARTMENT OF TRANSPORTATION dated October 25, 2001. Repeat the (1) Within 3,000 flight cycles after doing the repair: Do a general visual inspection of inspection at least every 9,000 flight cycles Federal Aviation Administration until paragraph (d)(2) of this AD has been the repaired area for loose fasteners per Part done, as applicable. 4 of the Work Instructions of the service bulletin. If any loose fastener is found, before 14 CFR Part 39 Preventive Modification further flight, replace with a new fastener per [Docket No. 2000–NM–169–AD] (c) For Groups 3, 5, 6, and 8 airplanes: If the service bulletin. Then repeat the no cracking is found during any inspection inspection at least every 3,000 flight cycles RIN 2120–AA64 required by paragraph (a) of this AD, doing until permanent rivets are installed in the the preventive modification of the chem- repaired area, which ends the repetitive Airworthiness Directives; McDonnell milled pockets in the upper skin as specified inspections for this paragraph. Douglas Model DC–9–81 (MD–81), DC– in Part 5 of the Work Instructions of Boeing (2) Within 4,000 flight cycles after doing 9–82 (MD–82), DC–9–83 (MD–83), DC– Alert Service Bulletin 737–53A1210, the repair: Do an internal eddy current 9–87 (MD–87), and Model MD–88 Revision 1, including Appendix A and inspection of the skin, tear straps, and lap Airplanes excluding Evaluation Form, dated October joint in each adjacent bay of the repaired area 25, 2001, ends the repetitive inspections for for cracking, per Part 4 of the Work AGENCY: Federal Aviation the modified area only. Instructions of the service bulletin. If any Administration, DOT. cracking is found, before further flight, repair ACTION: Notice of proposed rulemaking Corrective Actions per a method approved by the Manager, (d) If any cracking is found during any Seattle ACO, or per data meeting the type (NPRM). inspection required by paragraph (a) or (b) of certification basis of the airplane approved SUMMARY: This document proposes the this AD, before further flight, do the actions by a Boeing Company DER who has been specified in paragraphs (d)(1) and (d)(2) of authorized by the FAA to make such adoption of a new airworthiness this AD, as applicable, per the Work findings. For a repair method to be approved directive (AD) that is applicable to Instructions of Boeing Alert Service Bulletin by the Manager, Seattle ACO, as required by certain McDonnell Douglas airplanes. 737–53A1210, Revision 1, including this paragraph, the approval letter must This proposal would require reversing Appendix A and excluding Evaluation Form, specifically reference this AD. the ground stud installation of the main

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battery, and installing a new nameplate for comments, specified above, will be Therefore, all of these models may be on the cover of the battery. This action considered before taking action on the subject to the same unsafe condition. is necessary to prevent damage to proposed rule. The proposals contained Other Related Rulemaking equipment or possible fire in the in this action may be changed in light electrical/electronics equipment of the comments received. Submit The FAA, in conjunction with Boeing compartment due to electrical arcing comments using the following format: and operators of Model Douglas DC–9– between the ground stud of the main • Organize comments issue-by-issue. 81 (MD–81), DC–9–82 (MD–82), DC–9– battery and adjacent structure. This For example, discuss a request to 83 (MD–83), DC–9–87 (MD–87), and action is intended to address the change the compliance time and a Model MD–88 airplanes, has reviewed identified unsafe condition. request to change the service bulletin all aspects of the service history of those DATES: Comments must be received by reference as two separate issues. airplanes to identify potential unsafe August 4, 2003. • For each issue, state what specific conditions and to take appropriate ADDRESSES: Submit comments in change to the proposed AD is being corrective actions. This proposed triplicate to the Federal Aviation requested. airworthiness directive (AD) is one of a Administration (FAA), Transport • Include justification (e.g., reasons or series of corrective actions identified Airplane Directorate, ANM–114, data) for each request. during that process. We have previously Attention: Rules Docket No. 2000–NM– Comments are specifically invited on issued several other ADs and may 169–AD, 1601 Lind Avenue, SW., the overall regulatory, economic, consider further rulemaking actions to Renton, Washington 98055–4056. environmental, and energy aspects of address the remaining identified unsafe Comments may be inspected at this the proposed rule. All comments conditions. location between 9 a.m. and 3 p.m., submitted will be available, both before Explanation of Relevant Service Monday through Friday, except Federal and after the closing date for comments, Information holidays. Comments may be submitted in the Rules Docket for examination by via fax to (425) 227–1232. Comments interested persons. A report The FAA has reviewed and approved may also be sent via the Internet using summarizing each FAA-public contact McDonnell Douglas Alert Service the following address: 9-anm- concerned with the substance of this Bulletin MD–80–24A159, Revision 01, [email protected]. Comments sent proposal will be filed in the Rules dated January 24, 2000, which describes via fax or the Internet must contain Docket. procedures for reversing the ground ‘‘Docket No. 2000–NM–169–AD’’ in the Commenters wishing the FAA to stud of the main battery and installing subject line and need not be submitted acknowledge receipt of their comments a nameplate at stations Y=110.000 and in triplicate. Comments sent via the submitted in response to this action Z=39.000 in the lower nose frame area. Internet as attached electronic files must must submit a self-addressed, stamped The manufacturer advises that reversing be formatted in Microsoft Word 97 or postcard on which the following the ground stud installation will allow 2000 or ASCII text. statement is made: ‘‘Comments to easier access to tighten the ground stud The service information referenced in Docket Number 2000–NM–169–AD.’’ nut to proper torque, which will the proposed rule may be obtained from The postcard will be date stamped and minimize the possibility of the ground Boeing Commercial Aircraft Group, returned to the commenter. stud coming loose and causing arcing or Long Beach Division, 3855 Lakewood further damage. Installation of the Boulevard, Long Beach, California Availability of NPRMs nameplate will clarify installation and 90846, Attention: Data and Service Any person may obtain a copy of this torque requirements for future Management, Dept. C1–L5A (D800– NPRM by submitting a request to the maintenance. Accomplishment of the 0024). This information may be FAA, Transport Airplane Directorate, actions specified in the service bulletin examined at the FAA, Transport ANM–114, Attention: Rules Docket No. is intended to adequately address the Airplane Directorate, 1601 Lind 2000–NM–169–AD, 1601 Lind Avenue, identified unsafe condition. Avenue, SW., Renton, Washington; or at SW., Renton, Washington 98055–4056. Explanation of Requirements of the FAA, Los Angeles Aircraft Discussion Proposed Rule Certification Office, 3960 Paramount Boulevard, Lakewood, California. As part of its practice of re-examining Since an unsafe condition has been FOR FURTHER INFORMATION CONTACT: all aspects of the service experience of identified that is likely to exist or Elvin Wheeler, Aerospace Engineer, a particular aircraft whenever an develop on other products of this same Systems and Equipment Branch, ANM– accident occurs, the FAA has become type design, the proposed AD would 130L, FAA, Los Angeles Aircraft aware of a report indicating that heat require accomplishment of the actions Certification Office, 3960 Paramount damage had been detected on the specified in the service bulletin Boulevard, Lakewood, California ground stud of the main battery and on described previously. adjacent structure of a Model DC–9–82 90712–4137; telephone (562) 627–5344; Changes to 14 CFR Part 39/Effect on the (MD–82) airplane. The heat damage has fax (562) 627–5210. Proposed AD SUPPLEMENTARY INFORMATION: been attributed to a loose or inadequately tightened ground stud of On July 10, 2002, the FAA issued a Comments Invited the main battery, which resulted in new version of 14 CFR part 39 (67 FR Interested persons are invited to electrical arcing. Such electrical arcing 47997, July 22, 2002), which governs the participate in the making of the could result in damage to equipment or FAA’s airworthiness directives system. proposed rule by submitting such possible fire in the electrical/electronics The regulation now includes material written data, views, or arguments as equipment compartment. that relates to altered products, special they may desire. Communications shall The ground stud of the main battery flight permits, and alternative methods identify the Rules Docket number and on McDonnell Douglas Model DC–9–81 of compliance (AMOC). Because we be submitted in triplicate to the address (MD–81), DC–9–83 (MD–83), DC–9–87 have now included this material in part specified above. All communications (MD–87), and MD–88 airplanes is 39, we no longer need to include it in received on or before the closing date identical to that on the affected Model. each individual AD; however, this

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proposed AD identifies the office Flexibility Act. A copy of the draft Issued in Renton, Washington, on June 12, authorized to approve AMOCs. regulatory evaluation prepared for this 2003. action is contained in the Rules Docket. Kalene C. Yanamura, Cost Impact A copy of it may be obtained by Acting Manager, Transport Airplane There are approximately 1,224 Model contacting the Rules Docket at the Directorate, Aircraft Certification Service. DC–9–81 (MD–81), DC–9–82 (MD–82), location provided under the caption [FR Doc. 03–15333 Filed 6–17–03; 8:45 am] DC–9–83 (MD–83), DC–9–87 (MD–87), ADDRESSES. BILLING CODE 4910–13–P and Model MD–88 airplanes of the affected design in the worldwide fleet. List of Subjects in 14 CFR Part 39 The FAA estimates that 600 airplanes of Air transportation, Aircraft, Aviation DEPARTMENT OF TRANSPORTATION U.S. registry would be affected by this safety, Safety. proposed AD, that it would take Federal Aviation Administration approximately 2 work hours per The Proposed Amendment airplane to accomplish the proposed 14 CFR Part 39 actions, and that the average labor rate Accordingly, pursuant to the [Docket No. 2001–NM–164–AD] is $60 per work hour. Required parts authority delegated to me by the would cost approximately $38, per Administrator, the Federal Aviation RIN 2120–AA64 airplane. Based on these figures, the cost Administration proposes to amend part impact of the proposed AD on U.S. 39 of the Federal Aviation Regulations Airworthiness Directives; McDonnell operators is estimated to be $94,800, or (14 CFR part 39) as follows: Douglas Model MD–11 and –11F $158 per airplane. Airplanes The cost impact figure discussed PART 39—AIRWORTHINESS DIRECTIVES AGENCY: Federal Aviation above is based on assumptions that no Administration, DOT. operator has yet accomplished any of the proposed requirements of this AD 1. The authority citation for part 39 ACTION: Notice of proposed rulemaking action, and that no operator would continues to read as follows: (NPRM). accomplish those actions in the future if Authority: 49 U.S.C. 106(g), 40113, 44701. SUMMARY: This document proposes the this proposed AD were not adopted. The adoption of a new airworthiness cost impact figures discussed in AD § 39.13 [Amended] directive (AD) that is applicable to rulemaking actions represent only the 2. Section 39.13 is amended by certain McDonnell Douglas Model MD– time necessary to perform the specific 11 and –11F airplanes. This proposal actions actually required by the AD. adding the following new airworthiness directive: would require an initial general visual These figures typically do not include inspection of the power feeder cables of incidental costs, such as the time McDonnell Douglas: Docket 2000–NM–169– the integrated drive generator (IDG) and required to gain access and close up, AD. the fuel feed lines of engine plyons No. planning time, or time necessitated by Applicability: Model DC–9–81 (MD–81), 1 and No. 3 on the wings for proper other administrative actions. The DC–9–82 (MD–82), DC–9–83 (MD–83), DC– clearance and damage; corrective manufacturer may cover the cost of 9–87 (MD–87), and Model MD–88 airplanes, actions if necessary; and repetitive parts associated with this proposed AD, as listed in McDonnell Douglas Alert Service general visual inspections and a Bulletin MD80–24A159, Revision 01, dated subject to warranty conditions. terminating action for the repetitive Manufacturer warranty remedies also January 24, 2000; certificated in any category. Compliance: Required as indicated, unless inspections. This action is necessary to may be available for labor costs prevent potential chafing of the power associated with this proposed AD. As a accomplished previously. To prevent damage to equipment or feeder cables of the IDG in engine result, the costs attributable to the pylons No. 1 and No. 3 on the wings, proposed AD may be less than stated possible fire in the electrical/electronics equipment compartment due to electrical and consequent arcing on the fuel lines above. arcing between the ground stud of the main in the engine pylons and possible fuel Regulatory Impact battery and adjacent structure; accomplish fire. This action is intended to address The regulations proposed herein the following: the identified unsafe condition. (a) Within 1 year after the effective date of would not have a substantial direct DATES: Comments must be received by this AD, reverse the installation of the ground August 4, 2003. effect on the States, on the relationship stud for the main battery, and install a new between the national Government and nameplate on the cover of the battery; per ADDRESSES: Submit comments in the States, or on the distribution of McDonnell Douglas Alert Service Bulletin triplicate to the Federal Aviation power and responsibilities among the MD80–24A159, Revision 01, dated January Administration (FAA), Transport various levels of government. Therefore, 24, 2000. Airplane Directorate, ANM–114, it is determined that this proposal (b) Accomplishment of the actions Attention: Rules Docket No. 2001–NM– would not have federalism implications specified in paragraph (a) of this AD before 164–AD, 1601 Lind Avenue, SW., under Executive Order 13132. the effective date of this AD, in accordance Renton, Washington 98055–4056. For the reasons discussed above, I with McDonnell Douglas Service Bulletin Comments may be inspected at this certify that this proposed regulation (1) MD80–24A159, dated March 15, 1996, is location between 9 a.m. and 3 p.m., is not a ‘‘significant regulatory action’’ considered to be an acceptable method of Monday through Friday, except Federal under Executive Order 12866; (2) is not compliance with paragraph (a) of this AD. holidays. Comments may be submitted a ‘‘significant rule’’ under the DOT Alternative Methods of Compliance via fax to (425) 227–1232. Comments Regulatory Policies and Procedures (44 (c) In accordance with 14 CFR 39.19, the may also be sent via the Internet using FR 11034, February 26, 1979); and (3) if Manager, Los Angeles Aircraft Certification the following address: 9-anm- promulgated, will not have a significant Office, 3960 Paramount Boulevard, [email protected]. Comments sent economic impact, positive or negative, Lakewood, California, is authorized to via fax or the Internet must contain on a substantial number of small entities approve alternative methods of compliance ‘‘Docket No. 2001–NM–16–4AD’’ in the under the criteria of the Regulatory for this AD. subject line and need not be submitted

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in triplicate. Comments sent via the submitted in response to this action • Repositioning cables with improper Internet as attached electronic files must must submit a self-addressed, stamped clearance; and be formatted in Microsoft Word 97 for postcard on which the following • Repairing damage or replacing Windows or ASCII text. statement is made: ‘‘Comments to damaged cables or fuel feed lines with The service information referenced in Docket Number 2001–NM–164–AD.’’ new or serviceable cables or fuel feed the proposed rule may be obtained from The postcard will be date stamped and lines. Boeing Commercial Aircraft Group, returned to the commenter. The terminating action involves: Long Beach Division, 3855 Lakewood • Installing brackets to support the Boulevard, Long Beach, California Availability of NPRMs IDG harness; • 90846, Attention: Data and Service Any person may obtain a copy of this Installing new clamps on the power Management, Dept. C1–L5A (D800– NPRM by submitting a request to the feeder cables of the IDG of engine 0024). This information may be FAA, Transport Airplane Directorate, pylons No. 1 and No. 3; and • examined at the FAA, Transport ANM–114, Attention: Rules Docket No. Replacing the existing fairlead with Airplane Directorate, 1601 Lind 2001–NM–164–AD, 1601 Lind Avenue, a new clamp, and installing new tape; Avenue, SW., Renton, Washington; or at SW., Renton, Washington 98055–4056. as applicable. the FAA, Los Angeles Aircraft Accomplishment of the actions Certification Office, 3960 Paramount Discussion specified in the service bulletin is Boulevard, Lakewood, California 90712. As part of its practice of re-examining intended to adequately address the FOR FURTHER INFORMATION CONTACT: all aspects of the service experience of identified unsafe condition. Boeing also has issued Information Brett Portwood, Aerospace Engineer, a particular aircraft whenever an Notice MD11–54A011 R02 IN 02, dated Systems and Equipment Branch, ANM– accident occurs, the FAA has become July 11, 2002. The information notice 130L, FAA, Los Angeles Aircraft aware of reports indicating that the informs operators of a typographical Certification Office, 3960 Paramount power feeder cables of the integrated error for the string tie part number (P/ Boulevard, Lakewood, California 90712; drive generator (IDG) are riding against N) specified in the Boeing Alert Service telephone (562) 627–5350; fax (562) structure and fuel lines in engine pylons Bulletin MD11–54A011, Revision 02. 627–5210. No. 1 and No. 3 on the wings of certain The service bulletin specifies string tie SUPPLEMENTARY INFORMATION: McDonnell Douglas Model MD–11 and P/N 190L0F21G/A; the correct P/N is –11F airplanes. The cables are routed Comments Invited 109 LOF 21G/A. too closely to the components. This Interested persons are invited to condition, if not corrected, could result Explanation of Requirements of participate in the making of the in potential chafing of the power feeder Proposed Rule proposed rule by submitting such cables of the IDG in engine pylons No. Since an unsafe condition has been written data, views, or arguments as 1 and No. 3 on the wings, and they may desire. Communications shall identified that is likely to exist or consequent arcing on the fuel lines in develop on other products of this same identify the Rules Docket number and the engine pylons and possible fuel fire. be submitted in triplicate to the address type design, the proposed AD would specified above. All communications Other Related Rulemaking require accomplishment of the actions received on or before the closing date specified in the service bulletin The FAA, in conjunction with Boeing for comments, specified above, will be described previously. and operators of Model MD–11 and considered before taking action on the –11F airplanes, has reviewed all aspects Clarification of Procedures in Service proposed rule. The proposals contained of the service history of those airplanes Bulletin in this action may be changed in light to identify potential unsafe conditions of the comments received. Boeing has informed us that, although and to take appropriate corrective Submit comments using the following the service bulletin specifies two actions. This proposed airworthiness format: options (i.e., ‘‘Option 1’’ and ‘‘Option • Organize comments issue-by-issue. directive (AD) is one of a series of 2’’) for Conditions 1 through 3 findings, For example, discuss a request to corrective actions identified during that these actions are not optional. The change the compliance time and a process. We have previously issued intent is that the actions specified in request to change the service bulletin several other ADs and may consider Option 1 be accomplished until the reference as two separate issues. further rulemaking actions to address actions specified in Option 2 are • For each issue, state what specific the remaining identified unsafe accomplished at a later time. If an change to the proposed AD is being conditions. operator elects to accomplish the requested. Explanation of Relevant Service actions specified in Option 2 before the • Include justification (e.g., reasons or Information actions specified in Option 1, the data) for each request. actions specified in Option 1 do not Comments are specifically invited on We have reviewed and approved need to be accomplished. the overall regulatory, economic, Boeing Alert Service Bulletin MD11– environmental, and energy aspects of 54A011, Revision 02, dated May 31, Changes to 14 CFR part 39/Effect on the the proposed rule. All comments 2002. The service bulletin describes Proposed AD submitted will be available, both before procedures for an initial general visual On July 10, 2002, we issued a new and after the closing date for comments, inspection of the power feeder cables of version of 14 CFR part 39 (67 FR 47997, in the Rules Docket for examination by the IDG and the fuel feed lines of engine July 22, 2002), which governs the FAA’s interested persons. A report plyons No. 1 and 3 on the wings for airworthiness directives system. The summarizing each FAA-public contact proper clearance and damage; corrective regulation now includes material that concerned with the substance of this action if necessary; and repetitive relates to altered products, special flight proposal will be filed in the Rules general visual inspections and a permits, and alternative methods of Docket. terminating action for the repetitive compliance (AMOCs). Because we have Commenters wishing the FAA to inspections. The corrective actions now included this material in part 39, acknowledge receipt of their comments include: only the office authorized to approve

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AMOCs is identified in each individual under the criteria of the Regulatory daylight, hangar lighting, flashlight, or drop- AD. Flexibility Act. A copy of the draft light, and may require removal or opening of regulatory evaluation prepared for this access panels or doors. Stands, ladders, or Cost Impact action is contained in the Rules Docket. platforms may be required to gain proximity to the area being checked.’’ There are approximately 195 Model A copy of it may be obtained by MD–11 and –11F airplanes of the contacting the Rules Docket at the Condition 1: Proper Clearance and No affected design in the worldwide fleet. location provided under the caption Damage The FAA estimates that 74 airplanes of ADDRESSES. (b) If proper clearance exists and no U.S. registry would be affected by this damage is detected during any inspection proposed AD, that it would take List of Subjects in 14 CFR Part 39 required by paragraph (a) of this AD, do the approximately 1 work hour per airplane Air transportation, Aircraft, Aviation action(s) specified in paragraphs (b)(1), (b)(2), to accomplish the proposed inspection, safety, Safety. and (b)(3) of this AD, as applicable, per and that the average labor rate is $60 per Boeing Alert Service Bulletin MD11–54A011, work hour. Based on these figures, the The Proposed Amendment Revision 02, dated May 31, 2002. cost impact of the proposed AD on U.S. Accordingly, pursuant to the (1) For Group 1 and Group 2 airplanes identified in the service bulletin: Repeat the operators is estimated to be $4,440, or authority delegated to me by the $60 per airplane, per inspection cycle. inspection required by paragraph (a) of this Administrator, the Federal Aviation AD every 6 months until the modification It would take approximately 4 work Administration proposes to amend part required by paragraph (b)(2) or (b)(3) of this hours per airplane to accomplish the 39 of the Federal Aviation Regulations AD, as applicable, has been done. terminating action, at an average labor (14 CFR part 39) as follows: (2) For Group 1 airplanes identified in the rate of $60 per work hour. Required service bulletin: Within 18 months after the parts would cost approximately $91 per PART 39—AIRWORTHINESS effective date of this AD, install the brackets airplane. Based on these figures, the cost DIRECTIVES to support the IDG harness, and install new impact of this terminating action is clamps on the power feeder cables of the IDG estimated to be $24,494, or $331 per 1. The authority citation for part 39 of the No. 1 and No. 3 pylons. airplane. continues to read as follows: (3) For Group 2 airplanes identified in the service bulletin: Within 18 months after the The cost impact figures discussed Authority: 49 U.S.C. 106(g), 40113, 44701. effective date of this AD, replace the existing above are based on assumptions that no § 39.13 [Amended] fairlead with a new clamp, and install new operator has yet accomplished any of tape. the proposed requirements of this AD 2. Section 39.13 is amended by action, and that no operator would adding the following new airworthiness Condition 2: Improper Clearance and No accomplish those actions in the future if directive: Damage this proposed AD were not adopted. The McDonnell Douglas: Docket 2001–NM– (c) If improper clearance exists and no cost impact figures discussed in AD 164–AD. damage is detected during any inspection rulemaking actions represent only the Applicability: Model MD–11 and –11F required by paragraph (a) of this AD, do the action(s) specified in paragraphs (c)(1), (c)(2), time necessary to perform the specific airplanes, as listed in Boeing Alert Service Bulletin MD11–54A011, Revision 02, dated and (c)(3) of this AD, as applicable, per actions actually required by the AD. Boeing Alert Service Bulletin MD11–54A011, These figures typically do not include May 31, 2002; certificated in any category. Compliance: Required as indicated, unless Revision 02, dated May 31, 2002. incidental costs, such as the time accomplished previously. (1) For Group 1 and Group 2 airplanes required to gain access and close up, To prevent potential chafing of the power identified in the service bulletin: Before planning time, or time necessitated by feeder cables of the integrated drive generator further flight, reposition cables, and repeat other administrative actions. (IDG) in engine pylons No. 1 and No. 3 on the inspection required by paragraph (a) of Manufacturer warranty remedies may be the wings, and consequent arcing on the fuel this AD every 6 months until the available for labor costs associated with lines in the engine pylons and possible fuel modification required by paragraph (c)(2) or fire, accomplish the following: (c)(3) of this AD, as applicable, has been this proposed AD. As a result, the costs done. attributable to the proposed AD may be Note 1: Boeing has issued Information (2) For Group 1 airplanes identified in the less than stated above. Notice MD11–54A011 R02 IN 02, dated July service bulletin: Within 18 months after the 11, 2002. The information notice informs Regulatory Impact effective date of this AD, install the brackets operators of a typographical error for the to support the IDG harness, and install new The regulations proposed herein string tie part number (P/N) specified in the clamps on the power feeder cables of the IDG would not have a substantial direct Boeing Alert Service Bulletin MD11–54A011, of engine pylons No. 1 and No. 3. Revision 02. The service bulletin specifies effect on the States, on the relationship (3) For Group 2 airplanes identified in the string tie P/N 190L0F21G/A; the correct P/N service bulletin: Within 18 months after the between the national Government and is 109 LOF 21G/A. the States, or on the distribution of effective date of this AD, replace the existing power and responsibilities among the Initial Inspection fairlead with a new clamp, and install new tape. various levels of government. Therefore, (a) Within 30 days after the effective date it is determined that this proposal of this AD, do a general visual inspection of Condition 3: Improper Clearance and would not have federalism implications the power feeder cables of the IDG and the Damage Detected under Executive Order 13132. fuel feed lines of engine pylons No. 1 and 3 (d) If improper clearance exists and any For the reasons discussed above, I on the wings for proper clearance and damage is detected during any inspection certify that this proposed regulation (1) damage, per Boeing Alert Service Bulletin required by paragraph (a) of this AD, do the is not a ‘‘significant regulatory action’’ MD11–54A011, Revision 02, dated May 31, action(s) specified in paragraphs (d)(1), 2002. under Executive Order 12866; (2) is not (d)(2), and (d)(3) of this AD, as applicable, a ‘‘significant rule’’ under the DOT Note 2: For the purposes of this AD, a per Boeing Alert Service Bulletin MD11– general visual inspection is defined as ‘‘A 54A011, Revision 02, dated May 31, 2002. Regulatory Policies and Procedures (44 visual examination of an interior or exterior (1) For Group 1 and Group 2 airplanes FR 11034, February 26, 1979); and (3) if area, installation, or assembly to detect identified in the service bulletin: Before promulgated, will not have a significant obvious damage, failure, or irregularity. This further flight, reposition cables; repair economic impact, positive or negative, level of inspection is made under normally damage or replace damaged cables or fuel on a substantial number of small entities available lighting conditions such as feed lines with new or serviceable cables or

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fuel feed lines; and repeat the inspection require replacement of a support bracket for comments, specified above, will be required by paragraph (a) of this AD every 6 located on the left side of the lower considered before taking action on the months until the modification required by cargo compartment with a new ‘‘U’’ proposed rule. The proposals contained paragraph (d)(2) or (d)(3) of this AD, as shaped bracket. This action is necessary in this action may be changed in light applicable, has been done. (2) For Group 1 airplanes identified in the to prevent chafing of the power feeder of the comments received. service bulletin: Within 18 months after the cables of the APU, which could result Submit comments using the following in electrical arcing to adjacent structure format: effective date of this AD, install the brackets • to support the IDG harness, and install new and consequent fire in the airplane. This Organize comments issue-by-issue. clamps on the power feeder cables of the IDG action is intended to address the For example, discuss a request to of engine pylons No. 1 and No. 3. identified unsafe condition. change the compliance time and a (3) For Group 2 airplanes identified in the DATES: Comments must be received by request to change the service bulletin service bulletin: Within 18 months after the August 4, 2003. reference as two separate issues. effective date of this AD, replace the existing • For each issue, state what specific ADDRESSES: Submit comments in fairlead with a new clamp, and install new change to the proposed AD is being tape. triplicate to the Federal Aviation Administration (FAA), Transport requested. • Include justification (e.g., reasons or Credit for Earlier Service Bulletin Airplane Directorate, ANM–114, data) for each request. (e) Accomplishment of the actions Attention: Rules Docket No. 2000–NM– Comments are specifically invited on specified in this AD before the effective date 171–AD, 1601 Lind Avenue, SW., the overall regulatory, economic, of this AD per Boeing Alert Service Bulletin Renton, Washington 98055–4056. MD11–54A011, Revision 01, dated August environmental, and energy aspects of Comments may be inspected at this 22, 2002, is acceptable for compliance with the proposed rule. All comments location between 9 a.m. and 3 p.m., the requirements of this AD. submitted will be available, both before Monday through Friday, except Federal and after the closing date for comments, Alternative Methods of Compliance holidays. Comments may be submitted in the Rules Docket for examination by (f) In accordance with 14 CFR 39.19, the via fax to (425) 227–1232. Comments interested persons. A report Manager, Los Angeles Aircraft Certification may also be sent via the Internet using summarizing each FAA-public contact Office (ACO), FAA, is authorized to approve the following address: 9-anm- concerned with the substance of this alternative methods of compliance for this [email protected]. Comments sent AD. proposal will be filed in the Rules via fax or the Internet must contain Issued in Renton, Washington, on June 12, Docket. ‘‘Docket No. 2000–NM–171–AD’’ in the Commenters wishing the FAA to 2003. subject line and need not be submitted Kalene C. Yanamura, acknowledge receipt of their comments in triplicate. Comments sent via the submitted in response to this action Acting Manager, Transport Airplane Internet as attached electronic files must Directorate, Aircraft Certification Service. must submit a self-addressed, stamped be formatted in Microsoft Word 97 or postcard on which the following [FR Doc. 03–15334 Filed 6–17–03; 8:45 am] 2000 or ASCII text. statement is made: ‘‘Comments to BILLING CODE 4910–13–U The service information referenced in Docket Number 2000–NM–171–AD.’’ the proposed rule may be obtained from The postcard will be date stamped and Boeing Commercial Aircraft Group, returned to the commenter. DEPARTMENT OF TRANSPORTATION Long Beach Division, 3855 Lakewood Boulevard, Long Beach, California Availability of NPRMs Federal Aviation Administration 90846, Attention: Data and Service Any person may obtain a copy of this Management, Dept. C1–L5A (D800– 14 CFR Part 39 NPRM by submitting a request to the 0024). This information may be FAA, Transport Airplane Directorate, [Docket No. 2000–NM–171–AD] examined at the FAA, Transport ANM–114, Attention: Rules Docket No. Airplane Directorate, 1601 Lind RIN 2120–AA64 2000–NM–171–AD, 1601 Lind Avenue, Avenue, SW., Renton, Washington; or at SW., Renton, Washington 98055–4056. the FAA, Los Angeles Aircraft Airworthiness Directives; McDonnell Certification Office, 3960 Paramount Discussion Douglas Model DC–9–81 (MD–81), DC– Boulevard, Lakewood, California. 9–82 (MD–82), DC–9–83 (MD–83), and The FAA has received a report DC–9–87 (MD–87) Airplanes and Model FOR FURTHER INFORMATION CONTACT: indicating that the power feeder cables MD–88 Airplanes Elvin Wheeler, Aerospace Engineer; of the auxiliary power unit (APU) had Systems and Equipment Branch, ANM– chafed against a support bracket located AGENCY: Federal Aviation 130L, FAA, Los Angeles Aircraft in the forward lower cargo compartment Administration, DOT. Certification Office, 3960 Paramount of a Model MD–88 airplane. ACTION: Notice of proposed rulemaking Boulevard, Lakewood, California Investigation revealed that a spacer that (NPRM). 90712–4137; telephone (562) 627–5344; separates the cable from the bracket fax (562) 627–5210. might have been inadvertently omitted SUMMARY: This document proposes the SUPPLEMENTARY INFORMATION: during maintenance. This condition, if adoption of a new airworthiness not corrected, could cause chafing of the Comments Invited directive (AD) that is applicable to power feeder cables of the APU, which certain McDonnell Douglas Model DC– Interested persons are invited to could result in electrical arcing to 9–81 (MD–81), DC–9–82 (MD–82), DC– participate in the making of the adjacent structure and consequent fire 9–83 (MD–83), and DC–9–87 (MD–87) proposed rule by submitting such in the airplane. airplanes and Model MD–88 airplanes. written data, views, or arguments as This proposal would require a general they may desire. Communications shall Other Related Rulemaking visual inspection for chafing of the identify the Rules Docket number and The FAA, in conjunction with Boeing power feeder cables of the auxiliary be submitted in triplicate to the address and operators of Model MD–11 and power unit (APU), and repair if specified above. All communications –11F airplanes, has reviewed all aspects necessary. This proposal also would received on or before the closing date of the service history of those airplanes

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to identify potential unsafe conditions operators is estimated to be $90,666, or § 39.13 [Amended] and to take appropriate corrective $207 per airplane. 2. Section 39.13 is amended by actions. This proposed airworthiness The cost impact figure discussed adding the following new airworthiness directive (AD) is one of a series of above is based on assumptions that no directive: corrective actions identified during that operator has yet accomplished any of McDonnell Douglas: Docket 2000–NM–171– process. We have previously issued the proposed requirements of this AD AD. several other ADs and may consider action, and that no operator would further rulemaking actions to address accomplish those actions in the future if Applicability: Model DC–9–81 (MD–81), the remaining identified unsafe this proposed AD were not adopted. The DC–9–82 (MD–82), DC–9–83 (MD–83), and conditions. cost impact figures discussed in AD DC–9–87 (MD–87) airplanes, and Model MD– rulemaking actions represent only the 88 airplanes, as listed in McDonnell Douglas Explanation of Relevant Service Alert Service Bulletin MD80–24A105, time necessary to perform the specific Information Revision 02, dated January 24, 2000; actions actually required by the AD. The FAA has reviewed and approved certificated in any category. These figures typically do not include McDonnell Douglas Alert Service Compliance: Required as indicated, unless incidental costs, such as the time Bulletin MD80–24A105, Revision 02, accomplished previously. required to gain access and close up, dated January 24, 2000, which describes To prevent chafing of the power feeder planning time, or time necessitated by procedures for inspecting for any chafed cables of the auxiliary power unit (APU), other administrative actions. power feeder cables of the APU, and which could result in electrical arcing to repairing if necessary. The alert service Regulatory Impact adjacent structure and consequent fire in the bulletin also describes procedures for airplane; accomplish the following: replacing a support bracket for the The regulations proposed herein No Reporting Requirement power feeder cable on the left side of the would not have a substantial direct effect on the States, on the relationship (a) Although the alert service bulletin lower cargo compartment between referenced in this AD specifies to submit fuselage stations Y=218.000 and between the national Government and the States, or on the distribution of information to the manufacturer, this AD Y=237.000 with a new ‘‘U’’ shaped does not include such a requirement. bracket. The new bracket will eliminate power and responsibilities among the the need for a spacer and minimize the various levels of government. Therefore, Inspection for Chafing possibility of cable chafing and arcing. it is determined that this proposal (b) Within 1 year after the effective date of would not have federalism implications this AD, perform a general visual inspection Explanation of Requirements of under Executive Order 13132. for chafing of the power feeder cables of the Proposed Rule For the reasons discussed above, I auxiliary power unit, per McDonnell Douglas Since an unsafe condition has been certify that this proposed regulation (1) Alert Service Bulletin MD80–24A105, identified that is likely to exist or is not a ‘‘significant regulatory action’’ Revision 02, dated January 24, 2000. develop on other products of this same under Executive Order 12866; (2) is not (1) If no chafing is detected, no further type design, the proposed AD would a ‘‘significant rule’’ under the DOT action is required by this paragraph. require accomplishment of the actions Regulatory Policies and Procedures (44 (2) If any chafing is detected, before further specified in the alert service bulletin FR 11034, February 26, 1979); and (3) if flight, repair the cable(s) per the alert service described previously. promulgated, will not have a significant bulletin. economic impact, positive or negative, Note 1: For the purposes of this AD, a Changes to 14 CFR Part 39/Effect on the general visual inspection is defined as: ‘‘A Proposed AD on a substantial number of small entities under the criteria of the Regulatory visual examination of an interior or exterior On July 10, 2002, the FAA issued a Flexibility Act. A copy of the draft area, installation, or assembly to detect new version of 14 CFR part 39 (67 FR regulatory evaluation prepared for this obvious damage, failure, or irregularity. This level of inspection is made from within 47997, July 22, 2002), which governs the action is contained in the Rules Docket. touching distance unless otherwise specified. FAA’s airworthiness directives system. A copy of it may be obtained by A mirror may be necessary to enhance visual The regulation now includes material contacting the Rules Docket at the that relates to altered products, special access to all exposed surfaces in the location provided under the caption inspection area. This level of inspection is flight permits, and alternative methods ADDRESSES. of compliance (AMOC). Because we made under normally available lighting have now included this material in part List of Subjects in 14 CFR Part 39 conditions such as daylight, hangar lighting, 39, only the office authorized to approve flashlight, or droplight and may require AMOCs is identified in each individual Air transportation, Aircraft, Aviation removal or opening of access panels or doors. AD. safety, Safety. Stands, ladders, or platforms may be required to gain proximity to the area being checked.’’ Cost Impact The Proposed Amendment Replacement of a Support Bracket There are approximately 634 Accordingly, pursuant to the airplanes of the affected design in the authority delegated to me by the (c) Within 1 year after the effective date of worldwide fleet. The FAA estimates that Administrator, the Federal Aviation this AD, replace the support bracket for the 438 airplanes of U.S. registry would be Administration proposes to amend part power feeder cable located on the left side of the lower cargo compartment between affected by this proposed AD, that it 39 of the Federal Aviation Regulations fuselage stations Y=218.000 and Y=237.000 would take approximately 1 work hour (14 CFR part 39) as follows: with a new ‘‘U’’ shaped bracket. per airplane to accomplish the inspection and replacement of the PART 39—AIRWORTHINESS Alternative Methods of Compliance bracket, and that the average labor rate DIRECTIVES (d) In accordance with 14 CFR 39.19, the is $60 per work hour. Required parts Manager, Los Angeles Aircraft Certification would cost approximately $147 per 1. The authority citation for part 39 Office (ACO), FAA, is authorized to approve airplane. Based on these figures, the cost continues to read as follows: alternative methods of compliance for this impact of the proposed AD on U.S. Authority: 49 U.S.C. 106(g), 40113, 44701. AD.

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Issued in Renton, Washington, on June 12, The service information referenced in FAA, Transport Airplane Directorate, 2003. the proposed rule may be obtained from ANM–114, Attention: Rules Docket No. Kalene C. Yanamura, Aerospatiale, 316 Route de Bayonne, 2002–NM–169–AD, 1601 Lind Avenue, Acting Manager, Transport Airplane 31060 Toulouse, Cedex 03, France. This SW., Renton, Washington 98055–4056. Directorate, Aircraft Certification Service. information may be examined at the Discussion [FR Doc. 03–15337 Filed 6–17–03; 8:45 am] FAA, Transport Airplane Directorate, BILLING CODE 4910–13–P 1601 Lind Avenue, SW., Renton, The Direction Ge´ne´rale de l’Aviation Washington. Civile (DGAC), which is the airworthiness authority for France, FOR FURTHER INFORMATION CONTACT: Dan notified the FAA that an unsafe DEPARTMENT OF TRANSPORTATION Rodina, Aerospace Engineer; condition may exist on certain International Branch, ANM–116, FAA, Federal Aviation Administration Aerospatiale Model ATR42–500 and Transport Airplane Directorate, 1601 ATR72 series airplanes. The DGAC Lind Avenue, SW., Renton, Washington 14 CFR Part 39 advises that, after parking a Model 98055–4056; telephone (425) 227–2125; ATR42–500 series airplane with the [Docket No. 2002–NM–169–AD] fax (425) 227–1149. right-hand engine on, the flightcrew RIN 2120–AA64 SUPPLEMENTARY INFORMATION: tried unsuccessfully to start the left- Comments Invited hand engine. Investigation revealed wire Airworthiness Directives; Aerospatiale chafing on electrical rack 90VU between Interested persons are invited to Model ATR42–500 and ATR72 Series the carbon structure of the 95VU shelf participate in the making of the Airplanes and the main wire bundle. This chafing proposed rule by submitting such led to a short circuit, which burned AGENCY: Federal Aviation written data, views, or arguments as several wires of the bundle (including Administration, DOT. they may desire. Communications shall the left-hand engine ignition circuits) ACTION: identify the Rules Docket number and Notice of proposed rulemaking and the protective sheath (conduit). It be submitted in triplicate to the address (NPRM). was determined that the chafing and specified above. All communications subsequent electrical short circuit SUMMARY: This document proposes the received on or before the closing date probably occurred when the wire adoption of a new airworthiness for comments, specified above, will be bundle on the shelf was mispositioned directive (AD) that is applicable to considered before taking action on the during maintenance, and that this wire certain Aerospatiale Model ATR42–500 proposed rule. The proposals contained bundle is susceptible to such and ATR72 series airplanes. This in this action may be changed in light mispositioning. This created a direct proposal would require inspecting the of the comments received. wire bundle in the area of electrical rack Submit comments using the following contact between the wire bundle and 90VU to detect damage, verifying that format: the carbon shelf (an abrasive structure). the conduit around the wire bundle is • Organize comments issue-by-issue. This condition could also exist on in the proper position, and installing a For example, discuss a request to shelves 93VU and 94VU and, if not clamp between the wire bundles and the change the compliance time and a corrected, could result in the loss of carbon shelves structure. This action is request to change the service bulletin several functions essential for safe necessary to prevent chafing of a wire reference as two separate issues. flight. The design of the wire bundle routing bundle, which could result in an • For each issue, state what specific is the same on Model ATR42–500 and electrical short and potential loss of change to the proposed AD is being ATR72 series airplanes; therefore, these several functions essential for safe requested. • airplane models are subject to the flight. This action is intended to address Include justification (e.g., reasons or identified unsafe condition. the identified unsafe condition. data) for each request. Comments are specifically invited on DATES: Comments must be received by Explanation of Relevant Service the overall regulatory, economic, July 18, 2003. Information environmental, and energy aspects of ADDRESSES: Submit comments in the proposed rule. All comments The manufacturer has issued Avions triplicate to the Federal Aviation submitted will be available, both before de Transport Regional Service Bulletins Administration (FAA), Transport and after the closing date for comments, ATR42–92–0007 (for Model ATR42–500 Airplane Directorate, ANM–114, in the Rules Docket for examination by series airplanes) and ATR72–92–1007 Attention: Rules Docket No. 2002–NM– interested persons. A report (for Model ATR72 series airplanes), both 169–AD, 1601 Lind Avenue, SW., summarizing each FAA-public contact dated January 25, 2002. These service Renton, Washington 98055–4056. concerned with the substance of this bulletins describe procedures for Comments may be inspected at this proposal will be filed in the Rules inspecting the wire bundles in the area location between 9 a.m. and 3 p.m., Docket. of electrical rack 90VU to detect Monday through Friday, except Federal Commenters wishing the FAA to damage, verifying that the conduit holidays. Comments may be submitted acknowledge receipt of their comments around the wire bundles is in the proper via fax to (425) 227–1232. Comments submitted in response to this action position, and installing a clamp between may also be sent via the Internet using must submit a self-addressed, stamped the wire bundles and the carbon shelves the following address: 9-anm- postcard on which the following structure (93VU, 94VU, 95VU). [email protected]. Comments sent statement is made: ‘‘Comments to Accomplishment of the actions via fax or the Internet must contain Docket Number 2002–NM–169–AD.’’ specified in the applicable service ‘‘Docket No. 2002–NM–169–AD’’ in the The postcard will be date stamped and bulletins is intended to adequately subject line and need not be submitted returned to the commenter. address the identified unsafe condition. in triplicate. Comments sent via the The DGAC classified these service Internet as attached electronic files must Availability of NPRMs bulletins as mandatory and issued be formatted in Microsoft Word 97 or Any person may obtain a copy of this French airworthiness directives 2002– 2000 or ASCII text. NPRM by submitting a request to the 090–092(B) and 2002–091–066(B), both

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dated February 20, 2002, to ensure the actions, and that the average labor rate PART 39—AIRWORTHINESS continued airworthiness of these is $60 per work hour. Required parts DIRECTIVES airplanes in France. would cost approximately $259 per 1. The authority citation for part 39 airplane. Based on these figures, the cost FAA’s Conclusions continues to read as follows: impact of the proposed AD on U.S. These airplane models are operators is estimated to be $42,914, or Authority: 49 U.S.C. 106(g), 40113, 44701. manufactured in France and are type $499 per airplane. certificated for operation in the United § 39.13 [Amended] States under the provisions of §21.29 of The cost impact figure discussed 2. Section 39.13 is amended by the Federal Aviation Regulations (14 above is based on assumptions that no adding the following new airworthiness CFR 21.29) and the applicable bilateral operator has yet accomplished any of directive: airworthiness agreement. Pursuant to the proposed requirements of this AD Aerospatiale: Docket 2002–NM–169–AD. this bilateral airworthiness agreement, action, and that no operator would Applicability: Model ATR42–500 and the DGAC has kept the FAA informed accomplish those actions in the future if ATR72 series airplanes, certificated in any of the situation described above. The this AD were not adopted. The cost category, on which ATR Modification 1447 FAA has examined the findings of the impact figures discussed in AD has been incorporated and ATR Modification DGAC, reviewed all available rulemaking actions represent only the 4840 has not been incorporated. information, and determined that AD time necessary to perform the specific Compliance: Required as indicated, unless accomplished previously. action is necessary for products of this actions actually required by the AD. To prevent chafing of a wire bundle in the type design that are certificated for These figures typically do not include area of electrical rack 90VU, which could operation in the United States. incidental costs, such as the time result in an electrical short and potential loss required to gain access and close up, of several functions essential for safe flight, Explanation of Requirements of accomplish the following: Proposed Rule planning time, or time necessitated by other administrative actions. Modification Since an unsafe condition has been identified that is likely to exist or Regulatory Impact (a) Within 500 flight hours or 6 months develop on other airplanes of the same after the effective date of this AD, whichever occurs first: Do a detailed inspection to type design registered in the United The regulations proposed herein would not have a substantial direct detect damage of the wire bundles in the area States, the proposed AD would require of electrical rack 90VU, ensure that the accomplishment of the actions specified effect on the States, on the relationship conduit around the wire bundles is in the in the service bulletin described between the national Government and proper position, and install a clamp between previously. The actions would be the States, or on the distribution of the wire bundles and the carbon shelves required to be accomplished in power and responsibilities among the structure (94VU, 94VU, 95VU); in accordance accordance with the service bulletins various levels of government. Therefore, with Avions de Transport Regional Service described previously, except as it is determined that this proposal Bulletin ATR42–92–0007 (for Model ATR42– would not have federalism implications 500 series airplanes) or ATR72–92–1007 (for discussed below. Model ATR72 series airplanes), both dated under Executive Order 13132. Difference Between Proposed AD and January 25, 2002, as applicable. Repair any Service Bulletins For the reasons discussed above, I damaged wiring before further flight in certify that this proposed regulation (1) accordance with Chapter 20–27–17 of the The service bulletins do not provide is not a ‘‘significant regulatory action’’ applicable ATR Aircraft Schematic Manual, procedures to repair damaged wiring. dated October 1, 1995. under Executive Order 12866; (2) is not This proposed AD would require that Note 1: For the purposes of this AD, a a ‘‘significant rule’’ under the DOT damaged wiring be repaired in detailed inspection is defined as: ‘‘An Regulatory Policies and Procedures (44 accordance with the applicable ATR intensive visual examination of a specific Aircraft Schematic Manual, Chapter 20– FR 11034, February 26, 1979); and (3) if structural area, system, installation, or 27–17, dated October 1, 1995. promulgated, will not have a significant assembly to detect damage, failure, or economic impact, positive or negative, irregularity. Available lighting is normally Changes to 14 CFR Part 39/Effect on the on a substantial number of small entities supplemented with a direct source of good Proposed AD under the criteria of the Regulatory lighting at intensity deemed appropriate by the inspector. Inspection aids such as mirror, On July 10, 2002, the FAA issued a Flexibility Act. A copy of the draft magnifying lenses, etc., may be used. Surface new version of 14 CFR part 39 (67 FR regulatory evaluation prepared for this cleaning and elaborate access procedures 47997, July 22, 2002), which governs the action is contained in the Rules Docket. may be required.’’ FAA’s airworthiness directives system. A copy of it may be obtained by The regulation now includes material contacting the Rules Docket at the Alternative Methods of Compliance that relates to altered products, special location provided under the caption (b) In accordance with 14 CFR 39.19, the Manager, International Branch, ANM–116, flight permits, and alternative methods ADDRESSES. of compliance (AMOCs). It is not FAA, is authorized to approve alternative methods of compliance for this AD. necessary to include this material in List of Subjects in 14 CFR Part 39 Note 2: The subject of this AD is addressed each individual AD; however, the office Air transportation, Aircraft, Aviation in French airworthiness directives 2002– authorized to approve AMOCs is safety, Safety. 090–092(B) and 2002–091–066(B), both dated identified in paragraph (b) of this February 20, 2002. proposed AD. The Proposed Amendment Issued in Renton, Washington, on June 12, Cost Impact Accordingly, pursuant to the 2003. The FAA estimates that 86 airplanes authority delegated to me by the Kalene C. Yanamura, of U.S. registry would be affected by this Administrator, the Federal Aviation Acting Manager, Transport Airplane proposed AD, that it would take Administration proposes to amend part Directorate, Aircraft Certification Service. approximately 4 work hours per 39 of the Federal Aviation Regulations [FR Doc. 03–15338 Filed 6–17–03; 8:45 am] airplane to accomplish the proposed (14 CFR part 39) as follows: BILLING CODE 4910–13–U

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DEPARTMENT OF HEALTH AND • Implement definitions and reporting ENVIRONMENTAL PROTECTION HUMAN SERVICES formats and standards recommended by AGENCY the International Conference on Food and Drug Administration Harmonisation of Technical 40 CFR Part 52 Requirements for Registration of [MO 180–1180; FRL–7514–1] 21 CFR Parts 310, 312, 314, 320, 600, Pharmaceuticals for Human Use and by 601, and 606 the World Health Organization’s Approval and Promulgation of [Docket No. 2000N–1484] Council for International Organizations Implementation Plans; State of Missouri RIN 0910–AA97 of Medical Sciences; • Codify the agency’s expectations for AGENCY: Environmental Protection Safety Reporting Requirements for timely acquisition, evaluation, and Agency (EPA). Human Drug and Biological Products; submission of relevant safety ACTION: Proposed rule. Extension of Comment Period information for marketed drugs and SUMMARY: EPA proposes to approve a AGENCY: Food and Drug Administration, licensed biological products; • revision to the Missouri State HHS. Require that certain information, Implementation Plan (SIP) which ACTION: Proposed rule; extension of such as domestic reports of medication pertains to the control of emissions from comment period. errors, be submitted to the agency in an Perchloroethylene Dry Cleaning expedited manner; and SUMMARY: Installations in Kansas City and St. The Food and Drug • Administration (FDA) is extending to Clarify certain requirements and Louis areas, respectively. This revision October 14, 2003, the comment period make other minor revisions. will rescind two rules that have been for a proposed rule published in the FDA also proposed to amend its superseded by the statewide Maximum Federal Register of March 14, 2003 (68 postmarketing annual reporting Achievable Control Technology rule. There is no relaxation of controls by FR 12406). The proposed rule would regulations for human drug and licensed rescinding these rules. Approval of this amend the agency’s pre- and biological products by revising the revision will eliminate redundancy and postmarketing safety reporting content for these reports. regulations for human drug and conflicting requirements. In the final Interested persons were given until biological products. The agency is rules section of the Federal Register, July 14, 2003, to submit written or taking this action in response to a EPA is approving the state’s SIP revision request for more time to submit electronic comments to the agency on as a direct final rule without prior comments to FDA. the proposal. On May 7, 2003, FDA proposal because the Agency views this received a written request to allow an as a noncontroversial revision DATES: Submit written or electronic additional 90 days for interested amendment and anticipates no relevant comments on the proposed rule by adverse comments to this action. A October 14, 2003. persons to comment. FDA believes that an extension of 90 days to the comment detailed rationale for the approval is set ADDRESSES: Submit written comments period is appropriate, given the length forth in the direct final rule. If no to the Division of Dockets Management relevant adverse comments are received (HFA–305), Food and Drug and complexity of the proposed rule. Therefore, FDA is extending the in response to this action, no further Administration, 5630 Fishers Lane, rm. activity is contemplated in relation to 1061, Rockville, MD 20852. Submit comment period until October 14, 2003. This extension will provide the public this action. If EPA receives relevant electronic comments to adverse comments, the direct final rule [email protected] or on the with a total of 210 days to submit comments. will be withdrawn and all public Internet at http://accessdata.fda.gov/ comments received will be addressed in scripts/oc/dockets/commentdocket.cfm. II. Comments a subsequent final rule based on this FOR FURTHER INFORMATION CONTACT: proposed action. EPA will not institute For information concerning human Interested persons may submit to the a second comment period on this action. drug products: Audrey A. Thomas, Division of Dockets Management (see Any parties interested in commenting Center for Drug Evaluation and ADDRESSES) written or electronic on this action should do so at this time. Research (HFD–007), Food and comments on the proposal. Submit a Please note that if EPA receives adverse Drug Administration, 5600 Fishers single copy of electronic comments or comment on part of this rule and if that Lane, Rockville, MD 20857, 301– two paper copies of any mailed part can be severed from the remainder 594–5626. comments, except that individuals may of the rule, EPA may adopt as final For information concerning human submit one paper copy. Comments are those parts of the rule that are not the biological products: Miles Braun, to be identified with the docket number subject of an adverse comment. Center for Biologics Evaluation and found in brackets in the heading of this DATES: Comments on this proposed Research (HFM–220), Food and document. Received comments may be action must be received in writing by Drug Administration, 1401 seen in the Division of Dockets July 18, 2003. Rockville Pike, Rockville, MD Management between 9 a.m. and 4 p.m., 20852–1448, 301–827–6079. ADDRESSES: Comments may be mailed to Monday through Friday. Amy Algoe-Eakin, Environmental SUPPLEMENTARY INFORMATION: Dated: June 11, 2003. Protection Agency, Air Planning and I. Background Development Branch, 901 North 5th Jeffrey Shuren, In the Federal Register of March 14, Street, Kansas City, Kansas 66101, or E- Assistant Commissioner for Policy. mail her at [email protected]. 2003 (68 FR 12406), FDA published a [FR Doc. 03–15341 Filed 6–17–03; 8:45 am] proposed rule that, if finalized, would FOR FURTHER INFORMATION CONTACT: amend its pre-and postmarketing safety BILLING CODE 4160–01–S Amy Algoe-Eakin at (913) 551–7942. reporting regulations for human drug SUPPLEMENTARY INFORMATION: See the and biological products to: information provided in the direct final

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rule which is located in the rules Arch Street, Philadelphia, PA, 19103– specific sources on January 16, 1981, as section of the Federal Register. 2029. part of its final and interim final Dated: June 8, 2003. Your request for a hearing should be regulations implementing Section 3001 addressed to James J. Burke, Director, James B. Gulliford, of RCRA. These lists have been Waste and Chemicals Management amended several times, and are found at Regional Administrator, Region 7. Division (3WC00), U.S. EPA Region III, 40 CFR 261.31 and 261.32. [FR Doc. 03–15252 Filed 6–17–03; 8:45 am] 1650 Arch Street, Philadelphia, PA, We list these wastes as hazardous BILLING CODE 6560–50–P 19103–2029. because: (1) they typically and FOR FURTHER INFORMATION CONTACT: For frequently exhibit one or more of the characteristics of hazardous wastes ENVIRONMENTAL PROTECTION technical information concerning this identified in subpart C of 40 CFR part AGENCY document, please contact David M. Friedman at the address above, at (215) 261 (i.e., ignitability, corrosivity, 40 CFR Part 261 814–3395, or via e-mail at reactivity, and toxicity), or (2) they meet [email protected]. the criteria for listing contained in 40 [SW–FRL–7514–5] SUPPLEMENTARY INFORMATION: CFR 261.11(a)(2) or (a)(3). We also define residues from the Hazardous Waste Management Docket treatment, storage, or disposal of listed System; Identification and Listing of EPA has established an official docket hazardous wastes and mixtures Hazardous Waste; Proposed Exclusion for this action. The official docket containing listed hazardous wastes as consists of the petition submitted by hazardous wastes. (See 40 CFR AGENCY: Environmental Protection SPSA/Onyx, the results of a risk 261.3(a)(2)(iv) and (c)(2)(i), referred to as Agency. assessment which evaluates the the ‘‘mixture’’ and ‘‘derived-from’’ rules, ACTION: Proposed rule and request for potential impact of the petitioned waste respectively.) comment. on human health and the environment, Individual waste streams may vary, any public comments received, and however, depending on raw materials, SUMMARY: The Environmental Protection industrial processes, and other factors. Agency (EPA, also the Agency or we in other information related to this action. Thus, while a waste that is described in this preamble) is proposing to grant a The official docket for this proposed these regulations generally is hazardous, petition submitted by the Southeastern rule is located at the offices of U.S. EPA a specific waste from an individual Public Service Authority (SPSA) and Region III, 1650 Arch Street, facility that would otherwise meet the Onyx Environmental Services (Onyx), to Philadelphia, PA, 19103–2029, and is listing description may not be. exclude (or delist) on a one-time basis available for you to view from 8:30 a.m. For this reason, 40 CFR 260.20 and certain solid wastes generated at the to 5:00 p.m., Monday through Friday, 260.22 provide an exclusion procedure SPSA Power Plant in Portsmouth, except on Federal holidays. Please call which allows a person to demonstrate Virginia, from the lists of hazardous David M. Friedman at (215) 814–3395 that a specific listed waste from a waste. This waste is currently located at for appointments. The public may copy particular generating facility should not the SPSA Regional Landfill in Suffolk, material from the docket at $0.15 per be regulated as a hazardous waste, and Virginia. page. should, therefore, be delisted. The Agency has tentatively decided to Outline According to 40 CFR 260.22(a)(1), in grant the petition based on an The information in this preamble is order to have a waste excluded, a evaluation of specific information organized as follows: petitioner must first show that the waste provided by the petitioners. This generated at its facility does not meet tentative decision, if finalized, would I. Background A. What laws and regulations give EPA the any of the criteria for which the waste conditionally exclude the petitioned authority to delist waste? was listed. The criteria which we use to waste from the requirements of the B. What does SPSA/Onyx request in their list wastes are found in 40 CFR 261.11. hazardous waste regulations under the petition? An explanation of how these criteria Resource Conservation and Recovery II. Waste-Specific Information apply to a particular waste is contained Act (RCRA). A. How was the waste generated? in the background document for that The Agency is requesting comments B. What information did SPSA/Onyx listed waste. on this proposed decision. submit to support their petition? III. EPA’s Evaluation of the Petition In addition to the criteria that we DATES: To make sure we consider your A. What method did EPA use to evaluate considered when we originally listed comments on this proposed exclusion, risk? the waste, we are also required by the they must be postmarked by August 4, B. What other factors did EPA consider in provisions of 40 CFR 260.22(a)(2) to 2003. Comments received after the close its evaluation? consider any other factors (including of the comment period will be C. What conclusion did EPA reach? additional constituents), if there is a designated as late. EPA is not required IV. Conditions for Exclusion A. What conditions are associated with this reasonable basis to believe that these to consider late comments. factors could cause the waste to be Any person may request a hearing on exclusion? B. What happens if SPSA or Onyx fails to hazardous. this tentative decision to grant the meet the conditions of this exclusion? In a delisting petition, the petitioner petition by filing a request by July 3, V. Effect on State Authorization must demonstrate that the waste does 2003. The request must contain the VI. Effective Date not exhibit any of the hazardous waste information prescribed in 40 CFR VII. Administrative Requirements characteristics defined in subpart C of 260.20(d). I. Background 40 CFR part 261 (i.e., ignitability, ADDRESSES: Please send two copies of corrosivity, reactivity, and toxicity), and your comments to David M. Friedman, A. What Laws and Regulations Give EPA must present sufficient information for Technical Support Branch (3WC11), the Authority To Delist Waste? EPA to determine whether the waste Waste and Chemicals Management EPA published amended lists of contains any other constituents at Division, U.S. EPA Region III, 1650 hazardous wastes from non-specific and hazardous levels.

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A generator remains obligated under Logan ships its wastes to Onyx in 55- before SPSA received notification on RCRA to confirm that its waste remains gallon drums. February 27, 2002, that the ash was non-hazardous based on the hazardous On January 30, 2002, Onyx picked up subject to regulation as a hazardous waste characteristics defined in subpart a shipment of eighty-two drums from waste. The remaining ash (about 250 C of 40 CFR part 261, even if EPA has Logan. Fourteen of the drums contained tons or 575 cubic yards) has been delisted its waste. MEK rags used in the roller cleaning segregated and stored on a liner under process, and these drums were shipped a water- and wind-tight cover on an B. What Does SPSA/Onyx Request in with a Uniform Hazardous Waste adjacent area of the Landfill. The area of Their Petition? Manifest. Sixty drums in this shipment the Landfill where the material was On April 7, 2003, SPSA/Onyx contained only non-hazardous waste used as cover is cordoned off and petitioned EPA to exclude on a one-time and eight others, which were not further operations remain suspended in this basis a combustion ash generated at involved in this incident, were also area. SPSA’s waste-to-energy facility in designated as hazardous. All the drums B. What Information Did SPSA/Onyx Portsmouth, Virginia. The ash which is in this shipment were received at Submit To Support Their Petition? the subject of this petition is currently Onyx’s West Carrollton facility on located at SPSA’s Regional Landfill in February 9, 2002. In order to support their petition, Suffolk, Virginia. The total volume of In the petition, Onyx asserts that on SPSA/Onyx submitted detailed the subject combustion ash at the SPSA February 16, 2002, the fourteen drums descriptions of the chemicals used and Landfill was determined by SPSA/Onyx containing the used wipes were the wastes generated by Logan, detailed to be 1410 cubic yards. inadvertently included in a shipment of information related to the material The ash was produced by the routine eighty-three drums sent under a non- shipments received for destruction at combustion of a batch of municipal and hazardous waste manifest to Eagle SPSA’s Power Plant during the period of commercial solid waste which was Environmental Services, Inc.’s (Eagle) time between receipt of the shipment of processed in SPSA’s Refuse Derived waste processing facility in Dorchester, material from Eagle and notification of Fuel (RDF) plant and burned in SPSA’s South Carolina. Eagle operates a facility the shipping error, and validated Power Plant in Portsmouth, Virginia. A that processes non-hazardous industrial analytical results from representative small amount of this waste consisted of waste for recycling and disposal, and is samples of the ash obtained by SPSA/ materials containing the spent non- permitted for such activities by the Onyx on October 15, 2002 and January halogenated solvent, methyl ethyl South Carolina Department of Health 28, 2003. ketone (EPA Hazardous Waste Number and Environmental Control. Because of the number and variety of F005). Eagle emptied the fourteen drums waste streams that were processed at the containing the used wipes and SPSA waste-to-energy facility, we II. Waste-Specific Information processed their contents, along with requested that SPSA/Onyx analyze the A. How Was the Waste Generated? approximately twenty-three drums of ash for the entire list of constituents non-hazardous industrial waste, by found in Appendix IX to 40 CFR part In January, 2002, Logan Aluminum, shredding the combined material and 264. Inc. (Logan) sent a routine shipment of mixing it with sawdust to absorb any On October 15, 2002, SPSA/Onyx fourteen drums of hazardous waste free liquids that may have been present. collected eight samples and one generated at the Logan plant in On February 22, 2002, the processed duplicate sample from ash being stored Russellville, Kentucky, to Onyx’s material, totaling 47,380 pounds, was in a segregated waste pile at the SPSA facility in West Carrollton, Ohio. Logan shipped in a single container under a Regional Landfill. The ash that was used manufactures aluminum sheet used in non-hazardous waste manifest to for daily cover in the Landfill was not making beverage cans. Its process SPSA’s RDF plant in Portsmouth, sampled. The ash has been includes application of an FDA- Virginia. Here, this material was mixed homogenized by several processes such approved, food-safe coating by passing with other non-hazardous solid waste as loading out at the power plant, sheet aluminum through rollers. The and then burned in SPSA’s Power Plant. transportation and stockpiling, and, rollers are cleaned periodically by The ash resulting from combustion of therefore, the ash currently stored in the wiping them with cloth strips using this batch of RDF was delivered to the waste pile (which is lined with a virgin methyl ethyl ketone (MEK) as the SPSA Regional Landfill in Suffolk, geosynthetic liner and covered with a cleaning agent. MEK is the only solvent Virginia, on February 23, 2002. high-density polyethylene cap) was used by Logan in this process. Following standard procedure, the ash determined to be representative of that The used wipes are collected in was stockpiled there for use as daily portion of the ash which was used as drums along with other materials cover in the Landfill. daily cover. including personal protective According to Onyx, on February 26, Total analysis was performed on all equipment, excess coating, paper, 2002, it discovered its error and notified samples for the entire list of Appendix cardboard and packing materials. These the Ohio Environmental Protection IX constituents, which include volatiles, wipes are classified by the Kentucky Agency and Eagle that the drums had semi-volatiles, pesticides, herbicides, Department for Environmental been shipped to Eagle without the PCBs, polychlorinated dibenzodioxins Protection as spent solvent wastes. required hazardous waste manifest. On (PCDDs), polychlorinated dibenzofurans Onyx Environmental Services is a February 27, 2002, Eagle notified (PCDFs) metals, cyanide, and sulfide. company that provides a wide range of Chesapeake Waste Solutions, the waste Toxicity Characteristic Leaching environmental services to other broker that had arranged the shipment Procedure (TCLP) leachate analysis was companies. These services include from Eagle to SPSA, and Chesapeake performed on all Appendix IX metals. hazardous and non-hazardous waste Waste Solutions notified SPSA. SPSA TCLP leachate analysis was not management. then notified the Virginia Department of performed on the organic constituents Logan has a contractual arrangement Environmental Quality. or cyanide, since allowable holding with Onyx for the transportation and Approximately 510 tons (835 cubic times were exceeded, and any results disposal of hazardous and non- yards) of this ash had been used as daily obtained from such samples may not be hazardous wastes. Every two months, cover at the SPSA Regional Landfill reliable. Holding time requirements

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were met, however, for total constituent constituent by twenty. This twenty-fold laboratory using SW–846 Method 8280 analysis of the organic constituents and dilution is part of the TCLP protocol rather than the specified method, SW– cyanide. Therefore, in our evaluation of and represents the liquid to solid ratio 846 Method 8290. Method 8280 did not the organic constituents (except for the employed in the test procedure. yield results that were sufficiently PCDDs and PCDFs) and cyanide, we If the TCLP were performed on the sensitive for this evaluation. On January have calculated the theoretical actual waste, the concentration of this 28, 2003, four additional composite ash maximum leachate concentrations by constituent in the TCLP leachate could samples were collected and analyzed for applying the most conservative not exceed the calculated value derived total and leachable PCDDs and PCDFs assumption. from the procedure described above. concentrations using Method 8290. Analyzing a waste for TCLP The actual TCLP concentration, if The maximum total constituent and constituent concentrations involves determined, may be substantially less maximum leachate concentrations for application of the TCLP followed by than the calculated value because the all detected inorganic constituents in analysis of the TCLP leachate for the calculated value assumes that 100 SPSA/Onyx’s waste samples are constituents of concern. For a waste that percent of the constituent leaches from presented in Table 1. is a physical solid (i.e., a waste that does the waste. The detection limits presented in not contain a liquid phase), the PCDD and PCDF analysis of the Table 1 represent the lowest maximum theoretical leachate samples collected during the October concentrations quantifiable by SPSA/ concentration can be calculated by 15, 2002 sampling event were Onyx using appropriate methods to dividing the total concentration of the inadvertently analyzed by SPSA/Onyx’s analyze the waste.

TABLE 1.—MAXIMUM TOTAL CONSTITUENT AND LEACHATE CONCENTRATIONS 1 IN ASH

Total constituent TCLP leachate Inorganic constituents concentration concentration (mg/kg) (mg/1)

Antimony ...... 125 0.54 Arsenic ...... 45.9 0.18 Barium ...... 375 0.21 Beryllium ...... 1.7 <0.005 Cadmium ...... 34.9 0.11 Chromium ...... 808 <0.5 Cobalt ...... 27.3 <0.05 Copper ...... 2830 1.8 Lead ...... 1650 <0.5 Mercury ...... 6.8 0.003 Nickel ...... 449 0.065 Selenium ...... 4.6 <0.25 Silver ...... 9.5 <0.5 Thallium ...... 1.2 <2.0 Tin ...... 149 <0.1 Vanadium ...... 29.6 0.012 Zinc ...... 9810 8.5 Cyanide (total ...... 0.28 0.014 2 1 These levels represent the highest concentration of each constituent found in any sample. These levels do not necessarily represent the specific levels found in any one sample. 2 This value is the calculated theoretical maximum leachate concentration based on the maximum total constituent concentration. < Denotes that the constituent was not detected at the concentration specified in the table.

The maximum total constituent and SPSA/Onyx’s waste samples are maximum leachate concentrations for presented in Table 2. all detected organic constituents in

TABLE 2.—MAXIMUM TOTAL CONSTITUENT AND LEACHATE CONCENTRATIONS 1 IN ASH

Total constituent TCLP leachate Organic constituents concentration concentration (mg/kg) (mg/1)

Actone ...... 0.058 0.0029 3 Aceonitrile ...... <0.31 <0.01553 Bis(2-ethylhexyl)phthlate ...... 2.6 0.13 3 Butylbenzylphthalate ...... <2.0 <0.1 3 DDD ...... <0.0022 <0.00011 3 Endrin aldehyde ...... <0.0022 <0.00011 3 Heptachlor ...... <0.002 <0.0001 3 Methyl ethyl ketone (2-butanone) ...... <0.049 <0.00245 3 Methylene chloride ...... 0.0082 0.00014 3

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TABLE 2.—MAXIMUM TOTAL CONSTITUENT AND LEACHATE CONCENTRATIONS 1 IN ASH—Continued

Total constituent TCLP leachate Organic constituents concentration concentration (mg/kg) (mg/1)

2,3,7,8-TCDD 2 ...... 0.0175 0.00000000017 1 These levels represent the highest concentration of each constituent found in any sample. These levels do not necessarily represent the specific levels found in any one sample. 2 For risk assessment of PCDDs and PCDFs compounds, toxicity values are expressed as 2,3,7,8-TCDD equivalents (TEQs). 3 This value is the calculated theoretical maximum leachate concentration based on the maximum total constituent concentration. < Denotes that the constituent was not detected at the concentration specified in the table.

EPA requires that petitioners submit earth1r6/6pd/rcra_c/pd-o/dtsd.htm as standard risk assessment and exposure signed certifications affirming the well as in the public docket for this algorithms to perform this assessment. truthfulness, accuracy and completeness proposed rule. In most cases, because a delisted of the information in their delisting The Agency believes that the waste is no longer subject to hazardous petitions (See 40 CFR 260.22(i)(12)). EPACMTP fate and transport model waste regulation, the Agency is SPSA and Onyx each submitted signed represents a reasonable worst-case generally unable to predict, and does certifications stating that all submitted scenario for possible groundwater not presently control, how a petitioner information is true, accurate and contamination resulting from disposal will manage a waste after it is excluded. complete. of the petitioned waste in a landfill, and Therefore, we believe that it is that a reasonable worst-case scenario is inappropriate to consider extensive site- III. EPA’s Evaluation of the Petition appropriate when evaluating whether a specific factors when applying the fate A.What Method Did EPA Use To waste should be relieved of the and transport model. Evaluate Risk? protective management constraints of The back-calculation procedure the RCRA Subtitle C program. The use contrasts with the method used to For this delisting determination, we of a reasonable worst-case scenario compute the cumulative risk for a one- used information gathered by SPSA/ results in conservative values for the time delisting petition. To determine Onyx to identify plausible exposure compliance-point concentrations and cumulative risk, the calculations routes (i.e., groundwater, surface water, insures that the waste, once removed proceed in a forward direction. and air) for hazardous constituents from hazardous waste regulation, will Beginning with the leachate and total present in the petitioned waste. Because not pose a significant threat to human waste concentrations for each of its physical form, we determined that health or the environment. constituent in the waste (source disposal in a RCRA Subtitle D landfill In assessing potential risks to concentrations), the waste volume and was the most reasonable, worst-case groundwater, we use the estimated exposure parameters are used to (least protective) disposal scenario for waste volume and the maximum estimate the upper-bound excess SPSA/Onyx’s petitioned waste. We then measured or calculated leachate lifetime cancer risks(risk) and used a fate and transport model to concentrations as inputs to the DRAS noncarcinogenic hazards (hazard). The predict the release of hazardous program to estimate the constituent risk is said to be cumulative because constituents from the petitioned waste concentrations in the groundwater at a risks and hazards are summed once it is disposed of, in order to hypothetical receptor well separately for receptors (resident adults evaluate the potential impact on human downgradient from the disposal site. and children) across all applicable health and the environment. To perform Using an established risk level, the waste constituents and exposure this evaluation, we used a Windows- DRAS program can back-calculate pathways to obtain an estimate of the based software tool, the Delisting Risk receptor well concentrations (referred to total individual risk and hazard for each Assessment Software Program (DRAS), as a compliance-point concentration) receptor. Risk is the probability that a to estimate the potential releases of using standard risk assessment receptor will develop cancer. Risk is waste constituents and to predict the algorithms and Agency health-based estimated based on a unique set of risk associated with those releases. numbers. exposure, model, and toxicity DRAS accomplishes this using several For constituents which are not assumptions. EPA models including the EPA detected in leachate analysis, the DRAS Hazard is defined as the potential for Composite Model for Leachate requires that the detection limit be noncarcinogenic health effects as a Migration with Transformation Products entered along with the other data. In result of exposure to constituents of (EPACMTP) fate and transport model for these circumstances, the DRAS uses concern, averaged over an exposure estimating groundwater releases. For a one-half the detection limit to calculate period of less than an entire lifetime. A detailed description of the DRAS risk. We believe it is inappropriate to hazard is not a probability but rather a program and the EPACMPT model, See evaluate constituents which are not measure (expressed as a ratio) of the 65 FR 58015, September 27, 2000. detected in any sample analyzed, if an magnitude of a receptor’s potential Subsequent revisions to the DRAS appropriate analytical method was used. exposure relative to a standard exposure program are described in 65 FR 75637 Similarly, the DRAS also predicts level. The standard exposure level is (December 4, 2000). The DRAS program possible risks associated with releases of calculated over an exposure period such is available on the World Wide Web at waste constituents through surface that there is no likelihood of adverse http://www.epa.gov/earth1r6/6pd/ pathways (e.g., volatilization or wind- health effects to potential receptors, rcra_c/pd-o/dras.htm. The technical blown particulate from the landfill). As including sensitive populations. support document for the DRAS in the groundwater analyses, the DRAS If a delisting evaluation is performed program is also available on the World uses the established acceptable risk for a one-time exclusion, the DRAS Wide Web at http://www.epa.gov/ level, the health-based data, and computes the cumulative carcinogenic

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risk by summing the carcinogenic risks petitioned waste under actual The estimated cumulative hazard for all waste constituents for a given conditions, and not reasonable worst index for this waste is calculated by exposure pathway and then summing case assumptions, we believe that DRAS to be 3.2 × 10–1. We likewise the carcinogenic risks for each pathway evidence of groundwater contamination believe that this risk is acceptable both analyzed in the delisting risk originating from a land-based waste because the value is within the assessment. The DRAS also computes management unit may be sufficient generally acceptable range of 1.0 to 0.1 the cumulative noncarcinogenic risk by basis for petition denial. and, for a one-time delisting, EPA summing the Hazard Quotients for all In this case, SPSA/Onyx has not Region III considers a cumulative waste constituents for a given exposure generated the subject ash until this hazard index less than or equal to 1 to pathway to obtain exposure pathway- recent incident (described earlier in this be protective of human health. specific Hazard Indexes (HIs), and then preamble) which resulted in a small We believe the data submitted in summing the HIs associated with each amount of the ash being used as daily support of the petition show that the exposure pathway analyzed. For a one- cover in the SPSA Regional Landfill. We waste will not pose a threat when time exclusion, the results of the have determined that it would not be disposed of in a RCRA Subtitle D cumulative risk assessment may be used helpful to request groundwater landfill. We, therefore, propose to grant in lieu of the calculated delisting levels. monitoring data since the small amount SPSA/Onyx’s request for a one-time Since this is a one-time delisting, we do of ash used as daily cover would not delisting for the 1410 cubic yards of ash not need to establish monitoring have a detectable impact on the currently located at the SPSA Regional concentrations for each batch of waste groundwater at this Regional Landfill. Landfill. that is subsequently managed under the exclusion. Therefore, we set the C. What Conclusion Did EPA Reach? IV. Conditions for Exclusion evaluation levels in the cumulative risk EPA believes that the information A. What Conditions Are Associated process at the established target risk provided by SPSA/Onyx provides a With This Exclusion? × –4 × –6 range (1 10 to 1 10 for reasonable basis to grant SPSA/Onyx’s carcinogenic waste constituents and a The proposed exclusion would apply petition. We, therefore, propose to grant only to the estimated 1410 cubic yards HI of 1.0 to 0.1 for noncarcinogenic SPSA/Onyx a one-time delisting for the waste constituents). Use of the of ash currently located at the SPSA 1410 cubic yards of petitioned ash Regional Landfill as described in SPSA/ cumulative risk analysis allows the risk currently located at the SPSA Regional associated with an individual waste Onyx’s petition. No ash other than the Landfill. This includes both the ash ash described in this petition could be constituent to extend to a less which has been segregated in a waste conservative risk level as long as the managed as nonhazardous waste under pile at the site as well as the ash that this exclusion. cumulative risk for the entire petitioned has been used as cover material in the waste lies below or within EPA’s target If SPSA and/or Onyx discovers that a Landfill. The data submitted to support condition or assumption related to the risk range. the petition and the Agency’s evaluation For calculation of delisting levels for characterization of this waste that was show that the constituents in the SPSA/ multi-year (batch) waste generation, used in the evaluation of this petition is Onyx ash are below health-based levels EPA Region III generally defines not as reported in the petition, SPSA used by the Agency for delisting acceptable risk levels as wastes with an and/or Onyx will be required to report decision-making, and that the ash does excess cancer risk of no more than 1 × any information relevant to that not exhibit any of the characteristics of 10–6 and a hazard quotient of no more condition or assumption in writing to a hazardous waste. than 0.1 for individual constituents. For the Regional Administrator and the a one-time delisting, EPA Region III For this delisting determination, we Virginia Department of Environmental evaluates the cumulative cancer risk used information gathered to identify Quality within 10 calendar days of and cumulative hazard index of the plausible exposure routes (i.e., discovering that condition. petitioned waste. A cumulative cancer groundwater, surface water, air) for The purpose of this condition is to risk less than 1 × 10–4 and a cumulative hazardous constituents present in the require SPSA and/or Onyx to disclose hazard index less than or equal to 1 are petitioned waste. We determined that new or different information that may considered to be protective of human disposal in a RCRA Subtitle D landfill be pertinent to the delisting. This health and will be considered is the most reasonable, worst-case provision will allow us to reevaluate the acceptable for this type of delisting disposal scenario for SPSA/Onyx’s exclusion based on this new determination. petitioned waste. We applied the DRAS information in order to determine if our described above to predict the original decision was correct. If we B. What Other Factors Did EPA maximum allowable concentrations of discover such information from any Consider in Its Evaluation? hazardous constituents that may be source, we will act on it as appropriate. We also consider the applicability of released from the petitioned waste after Further action may include repealing groundwater monitoring data during the disposal, and we determined the the exclusion, modifying the exclusion, evaluation of delisting petitions where potential impact of the disposal of or other appropriate action deemed the petitioned waste is currently SPSA/Onyx’s petitioned waste on necessary to protect human health or managed or was once managed in a human health and the environment. the environment. EPA has the authority land-based unit (e.g., a landfill or The estimated total cumulative risk under RCRA and the Administrative surface impoundment). posed by the waste, as calculated using Procedures Act, 5 U.S.C. 551 et seq. We use the results of groundwater the DRAS, is 4.1 × 10–5. We believe that (1978), (APA), to reopen the delisting monitoring data evaluations as a check this risk is acceptable both because the under the conditions described above. on the reasonable worst case evaluations value is within the generally acceptable SPSA/Onyx state in their petition that performed, in order to provide an range of 1 × 10–4 to 1 × 10–6 and, as the waste, if delisted, will remain at the additional level of confidence in our stated above, for a one-time delisting, SPSA Regional Landfill. However, in delisting decisions. Because EPA Region III considers a cumulative order to adequately track wastes that groundwater monitoring data are cancer risk less than 1 × 10–4 to be have been delisted, in the event that a descriptive of the impact of the protective of human health. decision is made to dispose of all or part

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of the ash off-site, we will require that VI. Effective Date power and responsibilities among the SPSA/Onyx provide a one-time EPA is today making a tentative various levels of government, as notification to any State regulatory decision to grant SPSA/Onyx’s petition. specified in Executive Order 13132 (64 agency to which or through which the This proposed rule, if made final, will FR 43255, August 10, 1999). This rule delisted waste will be transported for become effective immediately upon also is not subject to Executive Order disposal. SPSA/Onyx will be required to such final publication. The Hazardous 13045 (62 FR 19885, April 23, 1997), provide this notification at least 60 and Solid Waste Amendments of 1984 because it is not economically calendar days prior to commencing amended Section 3010 of RCRA to allow significant. these activities. Failure to provide such rules to become effective in less than six This rule does not involve technical notification will be a violation of the months when the regulated community standards; thus, the requirements of delisting, and may be grounds for does not need the six-month period to section 12(d) of the National revocation of the exclusion. come into compliance. That is the case Technology Transfer and Advancement here, because this rule, if finalized, Act of 1995 (15 U.S.C. 272) do not B. What Happens if SPSA or Onyx Fails would reduce the existing requirements apply. As required by section 3 of To Meet the Conditions of This for a facility generating hazardous Executive Order 12988 (61 FR 4729, Exclusion? wastes. In light of the unnecessary February 7, 1996), in issuing this rule, If SPSA or Onyx violates the terms hardship and expense that would be EPA has taken the necessary steps to and conditions established in the imposed on this petitioner by an eliminate drafting errors and ambiguity, effective date six months after exclusion, the Agency may start minimize potential litigation, and publication and the fact that a six- procedures to withdraw the exclusion, provide a clear legal standard for month deadline is not necessary to affected conduct. This rule does not and may initiate enforcement actions. achieve the purpose of RCRA Section impose an information collection V. Effect on State Authorizations 3010, EPA believes that this exclusion burden under the provisions of the should be effective immediately upon Paperwork Reduction Act of 1995 (44 This proposed exclusion, if final publication. These reasons also U.S.C. 3501 et seq.). promulgated, would be issued under the provide a basis for making this rule Federal RCRA delisting program. States, effective immediately, upon final List of Subjects in 40 CFR Part 261 however, may impose more stringent publication, under the Administrative Environmental protection, Hazardous regulatory requirements than EPA Procedures Act, 5 U.S.C. 553(d). waste, Recycling, Reporting and pursuant to Section 3009 of RCRA. VII. Administrative Requirements recordkeeping requirements. These more stringent requirements may Under Executive Order 12866 (58 FR Authority: Sec. 3001(f) RCRA, 42 U.S.C. include a provision which prohibits a 6921(f). Federally-issued exclusion from taking 51735, October 4, 1993), this action is effect in the State. Because a petitioner’s not a rule of general applicability and Dated: June 10, 2003. waste may be regulated under a dual therefore is not a ‘‘regulatory action’’ Donald S. Welsh, system (i.e., both Federal (RCRA) and subject to review by the Office of Regional Administrator, Region III. Management and Budget. Because this State (RCRA) or State (non-RCRA) For the reasons set forth in the action is a rule of particular programs), petitioners are urged to preamble, 40 CFR Part 261 is proposed applicability relating to a particular contact State regulatory authorities to to be amended as follows: determine the current status of their facility, it is not subject to the regulatory wastes under the State laws. flexibility provisions of the Regulatory PART 261—IDENTIFICATION AND Flexibility Act (5 U.S.C. 601 et seq.), or LISTING OF HAZARDOUS WASTE Furthermore, some States are to sections 202, 203, and 205 of the authorized to administer a delisting Unfunded Mandates Reform Act of 1995 1. The authority citation for Part 261 program in lieu of the Federal program (UMRA) (Pub. L. 104–4). Because the continues to read as follows: (i.e., to make their own delisting rule will affect only one facility, it will decisions). Therefore, this proposed Authority: 42 U.S.C. 6905, 6912(a), 6921, not significantly or uniquely affect small 6922, and 6938. exclusion, if promulgated, may not governments, as specified in section 203 apply in those authorized States, unless of UMRA, or communities of Indian Appendix IX of Part 261—[Amended] it is adopted by the State. If the tribal governments, as specified in 2. Table 1 of Appendix IX of Part 261 petitioned waste is managed in any Executive Order 13175 (65 FR 67249, is amended to add the following waste State with delisting authorization, November 6, 2000). For the same reason, stream in alphabetical order by facility SPSA/Onyx must obtain delisting this rule will not have substantial direct to read as follows: authorization from that State before the effects on the States, on the relationship waste may be managed as nonhazardous between the national government and Appendix IX to Part 261—Wastes in that State. the States, or on the distribution of Excluded Under §§ 260.20 and 260.22.

TABLE 1.—WASTES EXCLUDED FROM NON-SPECIFIC SOURCES

Facility Address Waste description

******* Southeastern Public Service Authority Suffolk, Virginia ...... Combustion ash generated from the burning of the spent solvent methyl ethyl (SPSA) and Onyx Environmental ketone (Hazardous Waste Number F005) and disposed of in a Subtitle D Services (Onyx). landfill. This is a one-time exclusion for 1410 cubic yards of ash and is effective after (insert publication date of the final rule). (1) Reopener language

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TABLE 1.—WASTES EXCLUDED FROM NON-SPECIFIC SOURCES—Continued

Facility Address Waste description

(a) If SPSA and/or Onyx discovers that any condition or assumption related to the characterization of the excluded waste which was used in the evaluation of the petition or that was predicted through modeling is not as reported in the petition, then SPSA and/or Onyx must report any information relevant to that condition or assumption, in writing, to the Regional Administrator and the Virginia Department of Environmental Quality within 10 calendar days of discovering that information. (b) Upon receiving information described in paragraph (a) of this section, regardless of its source, the Regional Adminis- trator will determine whether the reported condition requires further action. Further action may include repealing the exclusion, modifying the exclusion, or other appropriate action deemed necessary to protect human health or the environment. (2) Notification Requirements In the event that the delisted waste is transported off-site for disposal, SPSA/ Onyx must provide a one-time written notification to any State Regulatory Agency to which or through which the delisted waste described above will be transported at least 60 calendar days prior to the commencement of such activities. Failure to provide such notification will be deemed to be a violation of this exclusion and may result in revocation of the decision and other enforcement action.

*******

[FR Doc. 03–15361 Filed 6–17–03; 8:45 am] ADDRESSES: You may submit comments 20590, Telephone: 202–366–1740, or BILLING CODE 6560–50–P identified by Vehicle Compatibility Dee Y. Williams, National Highway DOT DMS Docket Number [NHTSA– Traffic Safety Administration, Room 2003–14623] and/or Rollover Mitigation 5208, 400 Seventh Street, SW., DEPARTMENT OF TRANSPORTATION DOT DMS Docket Number [NHTSA– Washington, DC 20590. Telephone: 2003–14622] by any of the following 202–366–0498. methods: Rollover Mitigation—Jim Simons, National Highway Traffic Safety • Administration Web Site: http://dms.dot.gov. National Highway Traffic Safety Follow the instructions for submitting Administration, Room 5208, 400 49 CFR Part 571 comments on the DOT electronic docket Seventh Street, SW., Washington, DC site. 20590, Telephone: 202–366–2555, or [Vehicle Compatibility, Docket No. NHTSA– • Fax: 1–202–493–2251. • Dee Y. Williams, National Highway 2003–14623; Rollover Mitigation, Docket No. Mail: Docket Management Facility; Traffic Safety Administration, Room NHTSA–2003–14622] U.S. Department of Transportation, 400 5208, 400 Seventh Street, SW., Seventh Street, SW., Nassif Building, Vehicle Compatibility and Rollover Washington, DC 20590. Telephone: Room PL–401, Washington, DC 20590– 202–366–0498. Mitigation Integrated Project Team 001. (IPT) Plans • Hand Delivery: Room PL–401 on SUPPLEMENTARY INFORMATION: the plaza level of the Nassif Building, Vehicle Compatibility AGENCY: National Highway Traffic 400 Seventh Street, SW., Washington, Safety Administration (NHTSA), DOT. DC, between 9 a.m. and 5 p.m., Monday Since the 1970s, vehicle compatibility ACTION: Notice of availability of through Friday, except Federal has been a concern to NHTSA. Recent documents. Holidays. sales and registrations of LTVs have Instructions: All submissions must steadily increased as a percentage of the SUMMARY: This notice announces the include the agency name and docket passenger vehicle fleet, with LTVs availability of NHTSA’s first two of four number. Note that all comments representing 50 percent of new vehicle high priority safety reports describing received will be posted without change sales in 2001 and 37 percent of vehicle the agency’s current and planned to http://dms.dot.gov, including any registrations. Consequently, this has led activities to address vehicle personal information provided. to an increased number of fatalities to compatibility and rollover mitigation. Docket: For access to the docket to car occupants who are struck by LTVs. The reports are available from the read background documents or This increase in passenger car fatalities Docket Management System, U.S. comments received, go to http:// has occurred even while the overall Department of Transportation, at dms.dot.gov at any time or to Room PL– fatalities for the U.S. fleet has stabilized http://dms.dot.gov or on NHTSA’s Web 401 on the plaza level of the Nassif or decreased over the past several years. site at http://www.nhtsa.dot.gov/people/ Building, 400 Seventh Street, SW., Therefore, NHTSA has made vehicle iptreports.html. While the documents Washington, DC, between 9 a.m. and 5 compatibility one of the agency’s are final, the agency is offering the p.m., Monday through Friday, except highest priorities. Initiatives the agency public the opportunity to comment on Federal Holidays. plans to pursue in improving vehicle the agency’s planned activities. The FOR FURTHER INFORMATION CONTACT: compatibility include: comments will be considered for future Vehicle Compatibility—Roger A. Saul, 1.Vehicle Strategies agency efforts. National Highway Traffic Safety a. Partner Protection DATES: Comments must be received no Administration, Room 5307, 400 b. Self Protection later than August 4, 2003. Seventh Street, SW., Washington, DC c. Lighting/Glare

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d. Reform CAFE Each document will describe the receives before the close of business on 2. Roadway Strategies safety problem and provide strategies the comment closing date indicated a. Improve Structural Engagement with the agency plans to pursue in increasing above under DATES. To the extent Roadside Hardware safety belt use and reducing impaired possible, we will also consider b. Increase Awareness driving. 3. Behavioral Strategies comments that Docket Management a. Consumer Information Program How Do I Prepare and Submit receives after that date. Comments? Please note that even after the Vehicle Rollover comment closing date, we will continue Your comments must be written and Vehicle rollover is also a great to file relevant information in the in English. To ensure that your concern to NHTSA. Many factors Docket as it becomes available. Further, comments are correctly filed in the contribute to the occurrence of rollover some people may submit late comments. Docket, please include the Docket crashes. Rollover crashes closely Accordingly, we recommend that you number of this document (Vehicle correlate with unsafe and reckless periodically check the Docket for new Compatibility, NHTSA–2003–14623; driving behaviors, poor road design and material. Rollover Mitigation, NHTSA–2003– vehicle type. Certain categories of 14622) in your comments. How Can I Read the Comments vehicles, such as sport utility vehicles Please send two paper copies of your Submitted By Other People? and small pickup trucks, are more prone comments to Docket Management or to rollover than other classes of light submit them electronically. The mailing You may read the comments by motor vehicles. In recognition of the address is U.S. Department of visiting Docket Management in person increasing rollover problem, NHTSA Transportation Docket Management, at Room PL–401, 400 Seventh Street, has also made finding solutions one of Room PL–401, 400 Seventh Street, SW., SW., Washington, DC from 10 a.m. to 5 the agency’s highest priorities. Washington, DC 20590. If you submit p.m., Monday through Friday. Initiatives the agency plans to pursue in your comments electronically, log onto You may also see the comments on reducing deaths and injuries attributable the Docket Management System Web the Internet by taking the following to rollover crashes include: site at http://dms.dot.gov and click on steps: 1.Vehicle Strategies ‘‘Help & Information’’ or ‘‘Help/Info’’ to • Go to the Docket Management a. Handling and Stability obtain instructions. System (DMS) Web page of the b. Reform CAFE Department of Transportation (http:// c. Ejection Mitigation How Can I Be Sure That My Comments d. Roof Crush Were Received? dms.dot.gov). • 2. Roadway and Roadside Improvements If you wish Docket Management to On that page, click on ‘‘search.’’ 3. Consumer Information Program notify you upon its receipt of your • On the next page ((http:// 4. Rollover Causation Study comments, enclose a self-addressed, dms.dot.gov/search/) type in the five- NHTSA believes the initiatives stamped postcard in the envelope digit Docket number shown at the described in these two IPT reports will containing your comments. Upon beginning of this document (Vehicle lead to both near-term and longer-term receiving your comments, Docket Compatibility -14623; Rollover solutions to improve vehicle Management will return the postcard by Mitigation—14622). Click on ‘‘search.’’ compatibility in the fleet and reduce mail. • On the next page, which contains crashes attributable to rollover. How Do I Submit Confidential Business Docket summary information for the NHTSA has also assembled IPTs to Information? Docket you selected, click on the address two other highway safety desired comments. You may also programs of high interest: safety belt use If you wish to submit any information download the comments. and impaired driving. For each of these under a claim of confidentiality, send Anyone is able to search the programs, the agency will issue final three copies of your complete electronic form of all comments IPT reports and provide the public with submission, including the information received into any of our dockets by the the same opportunity to comment on you claim to be confidential business name of the individual submitting the the planned agency activities. Similar to information, to the Chief Counsel, NCC– comment (or signing the comment, if the reports on vehicle compatibility and 01, National Highway Traffic Safety submitted on behalf of an association, rollover mitigation, the documents will Administration, Room 5219, 400 business, labor union, etc.). You may be final and comments received will be Seventh Street, SW., Washington, DC review DOT’s complete Privacy Act evaluated and incorporated, as 20590. Include a cover letter supplying Statement in the Federal Register appropriate into future agency efforts. the information specified in our published on April 11, 2000 (Volume Each of these documents can be found confidential business information 65, Number 70; Pages 19477–78) or you at future dates on NHTSA’s Web site at regulation (49 CFR part 512). In addition, send two copies from may visit http://dms.dot.gov. http://www.nhtsa.dot.gov/people/ which you have deleted the claimed iptreports.html and also on DOT’s Authority: 49 U.S.C. 30111, 30117, 30168; confidential business information to docket management system (DMS) at delegation of authority at 49 CFR 1.50 and Docket Management, Room PL–401, 400 http://dms.dot.gov/. The docket 501.8. Seventh Street, SW., Washington, DC numbers for each of the respective Issued on: June 12, 2003. 20590. reports will be as follows: Rose A. McMurray, ❏ Safety Belt Use NHTSA–2003–14620; Will the Agency Consider Late Associate Administrator for Planning, and Comments? Evaluation & Budget. ❏ Impaired Driving NHTSA–2003– In our response, NHTSA will consider [FR Doc. 03–15239 Filed 6–17–03; 8:45 am] 14621. all comments that Docket Management BILLING CODE 4910–59–P

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Notices Federal Register Vol. 68, No. 117

Wednesday, June 18, 2003

This section of the FEDERAL REGISTER techniques or other forms of information adults without dependent children contains documents other than rules or technology. (ABAWDs). Section 4121(b) of the Farm proposed rules that are applicable to the All comments will be summarized Security and Rural Reinvestment Act of public. Notices of hearings and investigations, and included in the request for Office of 2002, Public Law 107–171, which was committee meetings, agency decisions and Management and Budget approval of the signed into law on May 13, 2002, gave rulings, delegations of authority, filing of petitions and applications and agency information collection. All comments FNS $20 million in new 100% funds statements of organization and functions are will become a matter of public record. (the ABAWD grants). FNS has examples of documents appearing in this FOR FURTHER INFORMATION CONTACT: determined that it needs the new section. Barbara Hallman, telephone number category of information on the FNS– (703) 305–2383. 366A to separately track these funds in SUPPLEMENTARY INFORMATION: Title: its budget information system. The DEPARTMENT OF AGRICULTURE Operating Guidelines, Forms and funds benefit ABAWD food stamp Waivers. recipients (who are subject to a 3-month Food and Nutrition Service OMB Number: 0584–0083. time limit for FSP participation) to help them get jobs. The funding amount is Agency Information Collection Expiration Date: December 2005. Type of Request: Revision of a allocated by FNS to the State agency for Activities: Proposed Collection, the ABAWD grant. Because the funding Comment Request—Food Stamp currently approved collection. Abstract: In accordance with section amount figure for this item is provided Program: Federal Collection of State 11(e) of the Food Stamp Act of 1977 (the by FNS, the impact on the burden is Plan of Operations, Operating Act), 7 U.S.C. 2020(e), State agencies are negligible, and so there is no additional Guidelines and Forms required to submit a Plan of Operation burden for this as a budget item. The AGENCY: Food and Nutrition Service, specifying the manner in which the FNS–366A data for this item will allow USDA. Food Stamp Program will be conducted. FNS to compare this budget item against The State Plan of Operations, in actual expenditures. ACTION: Notice. accordance with current rules at 7 CFR Beginning July 1997, State agencies SUMMARY: In accordance with the 272.2, consists of a Federal/State were allowed to submit the FNS–366B Paperwork Reduction Act of 1995, the Agreement, annual budget and activity data electronically to the national Food and Nutrition Service (FNS) is statements, and specific attachments database files stored in FNS’ FSP publishing for public comment, a (such as plans if the State elects to Integrated Information System in lieu of summary of a proposed information conduct program information activities a paper report. The voluntary collection. The proposed collection is a or provide nutrition educational changeover from paper to electronic revision of a collection currently services). State Plans of Operation are a reporting of FNS–366B data by States approved under OMB No. 0584–0083. one-time effort with updates that are was done as part of FNS’ State provided as necessary. Cooperative Data Exchange (SCDEX) DATES: Comments on this notice must be Under section 16 of the Act, 7 U.S.C. Project. This project is being expanded received by August 18, 2003, to be 2025, the Secretary is authorized to pay over time as more FNS forms are assured of consideration. each State agency an amount equal to 50 transformed to electronic formats for ADDRESSES: Send comments and percent of all administrative costs State data entry. As of February 2003, a requests for copies of this information involved in each State agency’s total of nine State agencies submitted collection to Barbara Hallman, Chief, operation of the FSP. Under the FNS–366B data electronically and State Administration Branch, Food corresponding FSP regulations at 7 CFR 44 State agencies submitted paper Stamp Program, Food and Nutrition 272.2, the State agencies must submit reports. Service, USDA, 3101 Park Center Drive, annually to FNS for approval, a Budget Under section 11(o) of the Act, 7 Alexandria, VA 22302. Projection Statement (Form FNS–366A), U.S.C. 2020(o), each State agency was Comments are invited on: (a) Whether which projects the total costs for major required to develop a plan, no later than the proposed collection of information areas of FSP operations, and a Program October 1, 1987, for implementing an is necessary for the proper performance Activity Statement (Form FNS–366B), automated data processing (ADP) and of the functions of the Agency, which provides a summary of FSP information retrieval system to including whether the information will operations during the preceding fiscal administer the FSP. Corresponding FSP have practical utility; (b) the accuracy of year. The reports are required to regulations at 7 CFR 277.18 require that the Agency’s estimate of the burden of substantiate the costs the State agency a written plan of action, called an the proposed collection of information, expects to incur during the next fiscal Advance Planning Document (APD), be including the validity of the year. Form FNS–366A is submitted prepared to acquire proposed ADP methodology and assumptions used; (c) annually by August 15, for the services, systems or equipment. The ways to enhance the quality, utility, and upcoming fiscal year and Form FNS– frequency of the APD submission is at clarity of the information to be 366B must be submitted no later than 45 the discretion of the State agency. collected; and (d) ways to minimize the days after the end of each State agency’s Under section 7(i) of the Act, 7 U.S.C. burden of the collection of information fiscal year. 2016(i), the Secretary is authorized to on those who are to respond, including FNS is proposing to add a new permit State agencies to implement on- through the use of appropriate category of information to the FNS– line electronic benefit transfer (EBT) automated, electronic, mechanical, or 366A to report data on Employment and systems. The Secretary is authorized to other technological collection Training (E&T) grants for able-bodied establish standards for the required

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testing prior to implementation of any DEPARTMENT OF AGRICULTURE through the Youth Conservation Corps EBT system and analysis of the results must complete the following forms: (1) of implementation in a limited pilot Forest Service FS 1800–18, Youth Conservation Corps project area before expansion of the Application, and (2) FS–1800–3, Youth system. Any State requesting funding Information Collection; Youth Conservation Corps Medical History. for an EBT system must submit an APD. Conservation Corps Forest Service and Department of the Respondents: State agencies that AGENCY: Forest Service, USDA. Interior employees use the information administer the FSP. ACTION: Notice; request for comments. to evaluate the eligibility of each Number of Respondents: 53. applicant. Estimated Number of Responses per SUMMARY: In accordance with the The Youth Conservation Corps Respondent: Plan of Operation Updates: Paperwork Reduction Act of 1995, the stresses three important objectives: 53 State agencies once a year. Forest Service is seeking comments 1. Accomplish needed conservation Form FNS–366A: 53 State agencies from all interested individuals and work on public lands; once a year. organizations on the extension of a 2. Provide gainful employment for 15 Form FNS–366B: 53 State agencies previously approved information to 18 year old males and females from once a year. collection for forms FS–1800–18, Youth all social, economic, ethnic, and racial Advance Planning Documents: 15 Conservation Corps Application, and backgrounds; and State agencies once a year. FS–1800–3, Youth Conservation Corps 3. Foster, on the part of the 15 to 18 Advance Planning Documents for EBT year old youth, an understanding and Systems: 10 State agencies once a year. Medical History. The collected information will help the Forest Service appreciation of the Nation’s natural EBT Reporting: 41 State agencies resources and heritage. reporting four times a year. evaluate the employment eligibility of Estimate of Burden: Plan of Operation youth 15–18 years old through the Description of Information Collection Updates: The State agencies submit Plan Youth Conservation Corps Program. 1. Title: FS–1800–18, Youth updates at an estimate of 10 hours per Under this Program, the Forest Service Conservation Corps (YCC) Application. respondent, or 530 total hours. cooperates with other Federal agencies OMB Number: 0596–0084. Form FNS–366A: The State agencies to provide seasonal employment for Expiration Date of Approval: submit Form FNS–366A at an estimate youth. September 30, 2003. of 13 hours per respondent, or 689 total DATES: Comments must be received in Type of Request: Extension of an hours. writing on or before August 18, 2003 to information collection previously Form FNS–366B: The total burden for be assured of consideration. Comments approved by the Office of Management the collection of information for Form received after that date will be and Budget. FNS–366B is 18 hours per respondent, considered to the extent practicable. Abstract: Employees of the U.S. or 954 hours. ADDRESSES: All comments should be Department of Agriculture, Forest Outreach Plans: We estimate that up addressed to: United States Department Service and the U.S. Department of the to 25 States may submit an Outreach of Agriculture, Forest Service, Director, Interior, Fish and Wildlife Service, Plan over the next year at an estimate of Youth Conservation Corps, Senior, National Park Service and Bureau of 1 hour per respondent or 25 total hours. Youth and Volunteer Programs, Mail Land Management will evaluate the data PRWORA Plan Updates: We estimate Stop 1136, PO Box 96090, Washington, and determine the eligibility of each 34 States will choose one or more DC 20090–1136. youth for employment with the Youth options, and thus will have to respond, Comments also may be submitted via Conservation Corps. To be considered at an average .25 hours per response, or facsimile to (703) 605–5115 or by e-mail for employment with the Corps, each a total burden of 8.5 hours. to: syvp/[email protected]. youth must complete FS–1800–18, Advance Planning Documents: The public may inspect comments at Youth Conservation Corps Application Approximately 15 State agencies submit the Office of the Director, Senior, Youth Form. Applicants are asked to answer an APD each year at an estimate of 10 and Volunteer Programs, Forest Service, questions that include their name, social hours per respondent or 150 total hours. USDA, Room 1010, 1621 North Kent security number, date of birth, mailing Advance Planning Documents for EBT Street, Arlington, VA 22209. Visitors are address, and telephone number. The Systems: Approximately ten State asked to call (703) 605–4831 in advance applicant’s parents or guardian must agencies submit an APD each year for an to facilitate entrance into the office. sign the form. EBT system at an estimate of 35 hours FOR FURTHER INFORMATION CONTACT: Data gathered in this information per respondent, or 350 total hours. collection are not available from other EBT Reporting: None. Ransom Hughes, Youth Conservation Corps, Senior, Youth and Volunteer sources. Estimated Total Annual Burden on Estimate of Annual Burden: 6 Program at (703) 605–4854. Respondents: The total annual reporting minutes. and recordkeeping burden for OMB No. SUPPLEMENTARY INFORMATION: Type of Respondents: Youth 15 to 18 0584–0083 is estimated to be 2,707 Background years old. hours, a decrease of 225 hours from the Estimated Annual Number of previous estimate and currently Under the Youth Conservation Corps Respondents: 18,000. approved burden of 2,932 hours. The Act of August 13, 1970, as amended (16 Estimated Annual Number of decrease in the burden is due to a U.S.C. 1701)—1706), the U.S. Responses per Respondent: 1. decrease in the number of States who Department of Agriculture Forest Estimated Total Annual Burden on submit an APD and the time to complete Service in cooperation with the U.S. Respondents: 1,800 hours. an APD. Department of the Interior Fish and Wildlife Service, National Park Service Description of Information Collection Dated: June 11, 2003. and Bureau of Land Management 2. Title: FS–1800–3, Youth Roberto Salazar, provide seasonal employment for Conservation Corps Medical History. Administrator. eligible youth 15 to 18 years old. OMB Number: 0596–0084. [FR Doc. 03–15350 Filed 6–17–03; 8:45 am] Youth who seek training and Expiration Date of Approval: BILLING CODE 3410–30–U employment with the Forest Service September 30, 2003.

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Type of Request: Extension of an DEPARTMENT OF COMMERCE Officer, Room 10202, New Executive information collection previously Office Building, Washington, DC 20503. National Oceanic and Atmospheric approved by the Office of Management Dated: June 11, 2003. Administration and Budget. Gwellnar Banks, Abstract: To be considered for [I.D. 061203F] Management Analyst, Office of the Chief employment with the Corps, each youth Information Officer. must complete FS–1800–3, Youth Submission for OMB Review; [FR Doc. 03–15404 Filed 6–17–03; 8:45 am] Comment Request Conservation Corps Medical History BILLING CODE 3510–NK–S Form. Applicants are asked to answer The Department of Commerce has questions regarding their personal submitted to the Office of Management health. The purpose of FS–1800–3 is to and Budget (OMB) for clearance the DEPARTMENT OF COMMERCE certify the youth’s physical fitness to following proposal for collection of National Oceanic and Atmospheric work in the seasonal employment information under the provisions of the Administration Program. The applicant’s parents or Paperwork Reduction Act (44 U.S.C. guardian must sign the form. Chapter 35). [I.D. 061203G] Data gathered in this information Agency: National Oceanic and collection are not available from other Atmospheric Administration (NOAA). Submission for OMB Review; sources. Title: National Marine Sanctuaries - Comment Request Socioeconomic Impacts of Marine Estimate of Annual Burden: 14 The Department of Commerce has minutes. Reserves. Form Number(s): None. submitted to the Office of Management Type of Respondents: Youth 15 to 18 OMB Approval Number: 0648-0408. and Budget (OMB) for clearance the years old. Type of Request: Regular submission. following proposal for collection of Estimated Annual Number of Burden Hours: 1,330. information under the provisions of the Respondents: 18,000. Number of Respondents: 665. Paperwork Reduction Act (44 U.S.C. Average Hours Per Response: 2. Chapter 35). Estimated Annual Number of Agency: National Oceanic and Responses per Respondent: 1. Needs and Uses: NOAA’s National Marine Sanctuaries are authorized Atmospheric Administration (NOAA). Estimated Total Annual Burden on under the National Marine Sanctuary Title: Northeast Region Vessel Respondents: 4,200 hours. Act to use zoning to prohibit or restrict Monitoring and Communications. Comment Is Invited uses in certain portions (zones) of Form Number(s): None. sanctuaries. Ecological Reserves, OMB Approval Number: 0648–0404. The agency invites comments on the Sanctuary Preservation Areas, or Marine Type of Request: Regular submission. following: (a) Whether the proposed Reserves (no-take zones) are being Burden Hours: 974. collection of information is necessary proposed. There is a need to evaluate Number of Respondents: 150. for the stated purpose and the proper the socioeconomic impact that no-take Average Hours Per Response: 1 hour performance of the functions of the zones might have on different user for installation of a vessel monitoring agency, including whether the groups. Those activities that might be system (VMS); 2 minutes for verification information will have practical or displaced from no-take zones include of installation; 5 seconds for an scientific utility; (b) the accuracy of the commercial fishing operations, automatic position report; and 2 agency’s estimate of the burden of the recreational fishing operations, and minutes for a Letter of Authorization proposed collection of information, individuals takes of anything in the Exemption request. including the validity of the area. The surveys will collect Needs and Uses: Owners or operators methodology and assumptions used; (c) socioeconomic data for use by NOAA, of vessels that have caught 500 metric ways to enhance the quality, utility, and sanctuary advisory councils, and similar tons of herring in the past year, or clarity of the information to be participants in the planning process. intend to catch 500 metric tons in the collected; and (d) ways to minimize the Affected Public: Business or other for- current year, must equip their vessels burden of the collection of information profit organizations, individuals or with an approved Vessel Monitoring on respondents, including the use of households, and not-for-profit System (VMS). The VMS units automated, electronic, mechanical, or institutions. automatically report the vessel’s other technological collection Frequency: Annually, one-time. position at least once per hour when the techniques or other forms of information Respondent’s Obligation: Voluntary. vessel is underway. Vessel owners must technology. OMB Desk Officer: David Rostker, submit proof that the VMS has been (202) 395-3897. installed. Herring carriers may be Use of Comments Copies of the above information exempted from this requirement by All comments received in response to collection proposal can be obtained by obtaining a letter of authorization from this notice, including names and calling or writing Diana Hynek, NOAA. address when provided, will become a Departmental Paperwork Clearance Affected Public: Business or other for- matter of public record. Comments will Officer, (202) 482-0266, Department of profit organizations, individuals or be summarized and included in the Commerce, Room 6625, 14th and households. request for Office of Management and Constitution Avenue, NW, Washington, Frequency: On occasion, hourly. Budget. DC 20230 (or via the Internet at Respondent’s Obligation: Mandatory. [email protected]). OMB Desk Officer: David Rostker, Dated: June 11, 2003. Written comments and (202) 395–3897. Irving W. Thomas, recommendations for the proposed Copies of the above information Acting Deputy Chief Operations. information collection should be sent collection proposal can be obtained by [FR Doc. 03–15314 Filed 6–17–03; 8:45 am] within 30 days of publication of this calling or writing Diana Hynek, BILLING CODE 3410–11–P notice to David Rostker, OMB Desk Departmental Paperwork Clearance

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Officer, (202) 482-0266, Department of 709 West 9th Street, Juneau, AK, or management measures implemented in Commerce, Room 6625, 14th and NMFS, Federal Building, Room 517, 222 the groundfish fisheries in the Bering Constitution Avenue, NW, Washington, West 7th Avenue, Anchorage, AK. Sea and Aleutian Islands (BSAI) to DC 20230 (or via the Internet at NMFS is not accepting email or internet protect endangered Steller sea lions in [email protected]). comments. the area. In the analyses of the Written comments and FOR FURTHER INFORMATION CONTACT: cumulative effects of the action on the recommendations for the proposed David Cormany, (907) 271–5006. environment, it was determined that information collection should be sent commercial fishing and environmental SUPPLEMENTARY INFORMATION: On July 9, within 30 days of publication of this 1985 (50 FR 27914), NMFS published an changes (effects of a regime shift) may result in a conditionally significant notice to David Rostker, OMB Desk emergency interim rule to govern the adverse effect on northern fur seals. Officer, Room 10202, New Executive subsistence taking of fur seals by Alaska Therefore, while the subsistence harvest Office Building, Washington, DC 20503. Native (Aleut) residents of the Pribilof is not likely to have any direct or Dated: June 11, 2003. Islands. A final rule was subsequently indirect effects on the fur seal Gwellnar Banks, published on July 9, 1986 (51 FR population that would be considered 24828). The subsistence harvest of Management Analyst, Office of the Chief significant under NEPA, the cumulative Information Officer. northern fur seals on the Pribilof Islands effects of the subsistence harvest is governed by regulations at 50 CFR [FR Doc. 03–15405 Filed 6–17–03; 8:45 am] alternatives when added to the effects of 216 Subpart F—Pribilof Islands, Taking BILLING CODE 3510–22–S the groundfish fisheries on the harvest for Subsistence Purposes. These alternatives may result in a similar regulations were published under the cumulative effects finding as identified DEPARTMENT OF COMMERCE authority of the Fur Seal Act (FSA), 16 in NMFS (2001). U.S.C. 1151 et seq., and the Marine National Oceanic and Atmospheric Mammal Protection Act (MMPA), 16 Information and Comments Solicited Administration U.S.C. 1361 et seq. The purpose of these NMFS solicits comments and [I.D. 060603E] regulations was to provide for the information to identify the complete subsistence needs of the Pribilof Aleuts range of alternatives to be analyzed. Intent to Analyze the Effects of the using humane harvesting methods and Alternatives analyzed in this EIS may Subsistence Taking of Northern Fur to restrict taking by sex, age, and season include those identified below, plus Seals on the Pribilof Islands, Alaska for herd management purposes. additional alternatives identified AGENCY: National Marine Fisheries The Need for an EIS on this Action through the public scoping process and Service (NMFS), National Oceanic and through working with the Tribal An Environmental Assessment and a Governments and other constituent Atmospheric Administration (NOAA), Finding of No Significant Impact of the Commerce. groups. Potential alternatives that have harvest on the fur seal population have already been identified include the ACTION: Notice of intent; scoping been considered adequate to address the following: (1) status quo alternative- No meetings; request for comments. Agency’s NEPA compliance action will be taken to change existing responsibilities in the past. However, SUMMARY: NMFS intends to prepare an regulations at 50 CFR 216 subpart F. evidence is building that continued Environmental Impact Statement (EIS) The conduct and management of the management under the harvest regarding possible changes to the harvest will remain as it has been; (2) an regulations in combination with other subsistence harvest of the Pribilof alternative that combines some of the past, present, and future actions, may be Islands stock of northern fur seals. The existing regulations with agreed upon having a significant impact on the scope of the EIS will consist of a broad stipulations identified in the co- human environment. Therefore, review of the subsistence harvest management agreements between NMFS preparation of an EIS for the proposed management on the Pribilof Islands and the Tribal Governments pursuant to action may be required by NEPA and including the manner in which the section 119 of the MMPA; and (3) a implementing regulations at 40 CFR harvest is conducted. NMFS intends to harvest regime that is completely 1501.4. hold scoping meetings to receive public managed through co-management NMFS is required to publish a Notice input on the issues of concern and the pursuant to section 119 of the MMPA. of Intent (NOI) to, among other things, appropriate range of management NMFS has entered into co- describe the proposed scoping process, alternatives to be addressed in the EIS. management agreements with the Tribal including any scoping meetings to be In addition to holding the scoping Governments of St. Paul Island and St. held. The NOI also serves as the official meetings, NMFS solicits written George Island under section 119 of the notice that a Federal agency is comments related to the scope of the MMPA in 2000 and 2001, respectively. commencing preparation of an EIS analysis. These agreements are specific to the pursuant. conservation and management of DATES: Written comments will be NMFS will examine all activities northern fur seals and Steller sea lions accepted through September 16, 2003. addressing the conduct of the on the Pribilof Islands, with particular ADDRESSES: Written comments should subsistence harvest management. The attention to the subsistence take and use be addressed to the Assistant Regional cumulative effects section of the EIS of these animals. NMFS has worked Administrator, Protected Resources will address the incremental cumulative with both communities to integrate the Division, NMFS, P.O. Box 21668, effects of these management alternatives agreements into one management plan Juneau, AK 99802, Attn: Lori Durall. on northern fur seals when added to the for the purpose of recovering and Requests to be included on a mailing list effects of past, other present, or maintaining the fur seal population. of persons interested in the EIS should reasonably foreseeable future actions Under this alternative all current be sent to Mr. David Cormany at 222 including the significant effects finding regulations would be eliminated. West 7th Avenue, Box 43, Anchorage, of the Steller Sea Lion Protection NMFS is also seeking information on AK 99513. Comments may also be hand- Measures EIS (NMFS 2001). The EIS for the environmental, social and economic delivered to NMFS, Federal Building, Steller sea lions examined the effects of issues to be considered in the analysis.

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The direct and indirect effects sections (VAFB) has been issued to The Boeing an application followed by a 30–day of the EIS will present the impacts of Company (Boeing). public notice and comment period on each identified alternative on the DATES: Effective from May 20, 2003, any proposed authorizations for the human environment. Major issues are until May 20, 2004. incidental harassment of small numbers likely to include: the impact of of marine mammals. Within 45 days of ADDRESSES: A copy of the IHA and/or subsistence and commercial fisheries the application is available by writing to the close of the comment period, NMFS removals on this stock, the impacts of must either issue or deny issuance of Ms. Kaja Brix, Acting Chief, Marine regulated harvests on the subsistence the authorization. Mammal Conservation Division, Office needs, traditional and cultural values of of Protected Resources, NMFS, 1315 Summary of Request Alaskan Natives, and co-management of East-West Highway, Silver Spring, MD the subsistence harvest under section On January 28, 2003, NMFS received 20910–3225, or by telephoning one of 119 of the MMPA. an application from Boeing requesting the contacts listed here. an authorization for the harassment of Public Involvement FOR FURTHER INFORMATION CONTACT: small numbers of Pacific harbor seals Scoping is an open process for Kimberly Skrupky, (301) 713–2322, ext. (Phoca vitulina richardsi) and California determining the scope of issues to be 163 or Christina Fahy, (562) 980–4023. sea lions (Zalophus californianus) addressed and for identifying the SUPPLEMENTARY INFORMATION: incidental to harbor activities related to significant issues related to the the Delta IV/EELV, including: transport proposed action. A principle objective Background vessel operations, cargo movement of this process is to identify a range of Sections 101(a)(5)(A) and (D) of the activities, harbor maintenance dredging, reasonable management alternatives MMPA (16 U.S.C. 1361 et seq.) direct and kelp habitat mitigation operations. that, with analysis, will provide a clear the Secretary of Commerce to allow, In addition, northern elephant seals basis for distinguishing between the upon request, the incidental, but not (Mirounga angustirostris) may also be alternatives and selecting a preferred intentional taking of small numbers of incidentally harassed but in smaller alternative. marine mammals by U.S. citizens who numbers. The harbor where activities Scoping meetings will be held on the engage in a specified activity (other than will take place is on south VAFB Pribilof Islands, AK, and in Anchorage, commercial fishing) within a specified approximately 2.5 mi (4.02 km) south of AK. Dates have not been set at this time geographical region if certain findings Point Arguello, CA, and approximately and will follow the cessation of the 2003 are made and either regulations are 1 mi (1.61 km) north of the nearest subsistence harvest. Times and issued or, if the taking is limited to marine mammal pupping site (i.e., locations of the scoping meetings will harassment, notice of a proposed Rocky Point). An Incidental Harassment also be published in a subsequent authorization is provided to the public Authorization (IHA) was issued to notice. for review. Boeing on May 20, 2002 and remains in Dated: June 11, 2003. Permission for incidental takings may effect for a one-year period (see 67 FR Donna Wieting, be granted if NMFS finds that the taking 36151, May 23, 2002). Acting Director, Office of Protected Resources, will have no more than a negligible Specified Activities impact on the species or stock(s) and National Marine Fisheries Service. Additional information of the work [FR Doc. 03–15407 Filed 6–17–03; 8:45 am] will not have an unmitigable adverse impact on the availability of the species proposed for 2003 is contained in the BILLING CODE 3510–22–S or stock(s) for subsistence uses and that application, which is available upon the permissible methods of taking and request (see ADDRESSES) and in the Final US Air Force Environmental DEPARTMENT OF COMMERCE requirements pertaining to the monitoring and reporting of such taking Assessment for Harbor Activities National Oceanic and Atmospheric are set forth. Associated with the Delta IV Program at Administration NMFS has defined ‘‘negligible Vandenberg Air Force Base (ENSR International, 2001). [I.D. 031203A] impact’’ in 50 CFR 216.103 as: an impact resulting from the specified Comments and Responses Small Takes of Marine Mammals activity that cannot be reasonably expected to, and is not reasonably likely to, adversely On April 9, 2003 (68 FR 17351), Incidental to Specified Activities; affect the species or stock through effects on NMFS published a notice of receipt and Harbor Activities at Vandenberg Air annual rates of recruitment or survival. a 30–day public comment period was Force Base, CA Subsection 101(a)(5)(D) of the MMPA provided on the application and AGENCY: National Marine Fisheries established an expedited process by proposed authorization. That notice Service (NMFS), National Oceanic and which citizens of the United States can described the activity and anticipated Atmospheric Administration (NOAA), apply for an authorization to effects on marine mammals. Comments Commerce. incidentally take small numbers of were received from Boeing which ACTION: Notice of issuance of incidental marine mammals by harassment. The requested that the mitigation measure be harassment authorization. MMPA defines ‘‘harassment’’ as: modified to allow for the continuation any act of pursuit, torment, or annoyance of activities while seals are present. As SUMMARY: In accordance with provisions which (i) has the potential to injure a marine the Notice stated, the rocks near the of the Marine Mammal Protection Act mammal or marine mammal stock in the wild VAFB harbor are not typically used by (MMPA) as amended, notification is [‘‘Level A harassment’’]; or (ii) has the large numbers of harbor seals nor is potential to disturb a marine mammal or hereby given that an Incidental marine mammal stock in the wild by causing there pupping: ‘‘...on average the Harassment Authorization (IHA) to take disruption of behavioral patterns, including, number of harbor seals hauled out near small numbers of marine mammals by but not limited to, migration, breathing, the site is less than 30 and there is no harassment incidental to harbor nursing, breeding, feeding, or sheltering pupping at nearby sites’’ (68 Fed. Reg. activities related to the Delta IV/Evolved [‘‘Level B harassment’’]. 17351 at 17353). The monitoring that Expendable Launch Vehicle (EELV) at Subsection 101(a)(5)(D) establishes a was performed for the VAFB harbor South Vandenberg Air Force Base, CA 45–day time limit for NMFS review of dredging during the fall of 2001 and

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winter of 2002 established that seals flushing or other behaviors as a result of activities, this will be reported to NMFS routinely hauled out on the adjacent Boeing’s activities. immediately. rocks during ongoing activities within (6) The Delta Mariner and Consultation the harbor. On several occasions, these accompanying vessels will enter the seals flushed, apparently due to harbor only when the tide is too high for This action will not affect those activities on the dock or in the harbor. harbor seals to haul-out on the rocks marine mammal species listed under the However, when they did leave the rocks and the vessel will reduce speed 1.5 to Endangered Species Act (ESA), that are during low tide they would quickly 2 knots once the vessel is within 3 mi under the jurisdiction of NMFS, as these return or be replaced by other (4.83 km) of the harbor. The vessel will species are not expected to haulout on individuals in the same resting place. enter the harbor stern first, approaching VAFB and thereby potentially be This quick return to the original haulout the wharf and its mooring dolphins at affected through harassment and fleeing suggests that the response was short less than 0.75 knot. from the haulout. No other marine term and transient. Boeing’s experience (7) As alternate dredge methods are species listed under the ESA will be last year with the dredging and other explored, the dredge contractor may affected by Boeing’s harbor activities harbor activities, however, also introduce quieter techniques and related to the Delta IV/EELV at VAFB. demonstrated that stopping work when equipment. VAFB formally consulted with U.S. Fish and Wildlife Service (FWS) in 1998 on seals are present on the adjacent rocks Monitoring can have a considerable impact to the possible take of southern sea otters schedules and costs. The data collected As part of its application, Boeing during Boeing’s harbor activities at during last year’s harbor activities, provided a proposed monitoring plan south VAFB. A Biological Opinion was which is documented in the application for assessing impacts to harbor seals issued in August 2001. Southern sea for the IHA, supports the conclusion from the activities at south VAFB harbor otters were discussed in these reached by NMFS in the proposed IHA and for determining when mitigation documents and FWS recognized that that the occasional flushing of a limited measures should be employed. Boeing will restore sea otter habitat (i.e., number of seals from the rocks while A NMFS-approved and VAFB- kelp beds) in the vicinity of the harbor harbor activities are underway has designated biologically trained observer to replace kelp destroyed during minimal impact on the species. will monitor the area for pinnipeds dredging. In addition, the FWS noting Accordingly, Boeing requests that the during all harbor activities. During that VAFB has committed to a southern IHA provide that the continuation of nighttime activities, the harbor area will sea otter monitoring program designed activities at VAFB harbor is authorized be illuminated, and the monitor will use to detect the presence and possible while seals are present even in the event a night vision scope. Monitoring disturbance at the VAFB harbor area of flushing seals. activities will consist of: during dredging activities. (1) Conducting baseline observation of NMFS concurs that continuation of NEPA pinnipeds in the project area prior to activities would have a minimal impact initiating project activities. In accordance with section 6.01 of the on pinnipeds and has thus modified the (2) Conducting and recording NOAA Administrative Order 216–6 mitigation measures contained in the observations on pinnipeds in the (Environmental Review Procedures for authorization to allow for continuation vicinity of the harbor for the duration of Implementing the National of activities while seals are present. The the activity occurring when tides are Environmental Policy Act, May 20, mitigation measures still require marine low enough for pinnipeds to haul out 1999), NMFS has determined, based on mammal monitoring during all Boeing (2 ft, 0.61 m, or less). the content and analysis of Boeing’s activities in the harbor and reporting of (3) Conducting post-construction request for an IHA, and the Final EA for any possible disturbance of the harbor observations of pinniped haul-outs in Harbor Activities Associated with the seals associated with those activities. the project area to determine whether Delta IV Program at VAFB (ENSRI, Mitigation animals disturbed by the project 2001) that the proposed issuance of this activities return to the haul-out. IHA to Boeing by NMFS will not To reduce the potential for individually or cumulatively result in a Reporting disturbance from visual and acoustic significant impact on the quality of the stimuli associated with the activities Boeing will notify NMFS 2 weeks human environment as defined in 40 Boeing will undertake the following prior to initiation of each activity. After CFR 1508.27. Impacts are not expected marine mammal mitigating measures: each activity is completed, Boeing will to be outside the scope of that EA. (1) If activities occur during nighttime provide a report to NMFS 120 days prior Therefore, this action meets the hours, lighting will be turned on before to the expiration of this Authorization definition of a ‘‘Categorical Exclusion’’ dusk and left on the entire night to or within 120 days after the expiration and is exempted from further avoid startling harbor seals at night. of this Authorization if a new environmental review. (2) Activities will be initiated before Authorization is not being requested. dusk. This report will provide dates and Determinations (3) Construction noises must be kept locations of specific activities, details of NMFS had determined that the constant (i.e., not interrupted by periods seal behavioral observations, and impact of harbor activities related to the of quiet in excess of 30 minutes) while estimates of the amount and nature of Delta IV/EELV at VAFB, including: harbor seals are present. all takes of seals by harassment or in transport vessel operations, cargo (4) If activities cease for longer than other ways. In addition, the report will movement activities, harbor 30 minutes and harbor seals are in the include information on the weather, the maintenance dredging, and kelp habitat area, start-up of activities will include a tidal state, the horizontal visibility, and mitigation will result in the harassment gradual increase in noise levels. the composition (species, gender, and of small numbers of Pacific harbor seals, (5) A NMFS-approved marine age class) and locations of haul-out California sea lions, and northern mammal observer will visually monitor group(s). In the unanticipated event that elephant seals; would have no more the harbor seals on the beach adjacent any cases of pinniped injury or negligible impact on these marine to the harbor and on rocks for any mortality are judged to result from these mammal stocks; and would not have an

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unmitigable adverse impact on the DEPARTMENT OF COMMERCE FOR FURTHER INFORMATION CONTACT: availability of marine mammal stocks Kimberly Skrupky, (301) 713–2322, ext for subsistence uses. Northern fur seals, National Oceanic and Atmospheric 163 or Brad Smith, (907) 271–3023. Guadalupe fur seals, and Steller sea Administration SUPPLEMENTARY INFORMATION: lions are unlikely to be found in the area [I.D. 061203I] Background and therefore will not be affected. While behavioral modifications may be made Small Takes of Marine Mammals Sections 101(a)(5)(A) and (D) of the by those pinniped species ashore in Incidental to Specified Activities; MMPA (16 U.S.C. 1361 et seq.) direct order to avoid the resultant acoustic and Movement of Steel Drilling Caisson the Secretary of Commerce to allow, visual stimuli from the activity, there is through the Beaufort Sea from Cross upon request, the incidental, but not no potential for large-scale movements, Island, McCovey Prospect to Herschel intentional taking of small numbers of such as stampedes, since harbor seals, Island, Yukon Territory marine mammals by U.S. citizens who engage in a specified activity (other than California sea lions, and elephant seals AGENCY: National Marine Fisheries commercial fishing) within a specified haul out in small numbers near the site Service (NMFS), National Oceanic and geographical region if certain findings (maximum number of harbor seals Atmospheric Administration (NOAA), are made and either regulations are hauled out in one day estimated at 43 Commerce. issued or, if the taking is limited to seals, averaging at 21 seals per day, ACTION: Notice of receipt of application harassment, notice of a proposed maximum number of California sea and proposed incidental harassment authorization is provided to the public lions hauled out in one day is estimated authorization; request for comments. for review. at six). The effects of Boeing’s harbor Permission for incidental takings may activities are expected to be limited to SUMMARY: NMFS has received a request be granted if NMFS finds that the taking short-term and localized behavioral from EnCana Oil and Gas (USA) Inc. will have no more than a negligible changes. (EnCana) for an authorization to take impact on the species or stock(s) and Due to the localized nature of these small numbers of marine mammals by will not have an unmitigable adverse activities, the number of marine harassment incidental to movement of a impact on the availability of the species Steel Drilling Caisson (SDC) from Cross mammals potentially taken by or stock(s) for subsistence uses and that Island, McCovey Prospect, AK through harassment are estimated to be small. In the permissible methods of taking and the Beaufort Sea to Herschel Island in requirements pertaining to the addition, no take by injury and/or death the Yukon Territory and for associated is anticipated, and the potential for monitoring and reporting of such taking activities in the Beaufort Sea. If there is are set forth. temporary or permanent hearing a problem with this location for the NMFS has defined ‘‘negligible impairment is unlikely given the low SDC, the U.S. Outer Continental Shelf impact’’ in 50 CFR 216.103 as: noise levels expected at the site. No waters north of West Dock has been an impact resulting from the specified rookeries, mating grounds, areas of named as the backup location. Under activity that cannot be reasonably expected concentrated feeding, or other areas of the Marine Mammal Protection Act to, and is not reasonably likely to, adversely special significance for marine (MMPA), NMFS is requesting comments affect the species or stock through effects on mammals occur within or near south on its proposal to authorize EnCana to annual rates of recruitment or survival. VAFB harbor. incidentally take, by harassment, small Subsection 101(a)(5)(D) of the MMPA numbers of bowhead whales, beluga established an expedited process by Authorization whales, ringed seals, bearded seals, and which citizens of the United States can apply for an authorization to NMFS has issued an IHA to Boeing spotted seals in the above mentioned areas during August 2003 through incidentally take small numbers of for harbor activities related to the Detla marine mammals by harassment. The IV/EELV program at south VAFB for a January 2004 for SDC preparation, movement, refueling, and removal of MMPA defines ‘‘harassment’’ as: 1–year period. A copy of this IHA is any act of pursuit, torment, or annoyance available upon request (see ADDRESSES). equipment. The incidental take of polar which (i) has the potential to injure a marine The issuance of this IHA is contigent bears and walrus from EnCana’s mammal or marine mammal stock in the wild planned activities are not covered by upon adherence to the previously [‘‘Level A harassment’’]; or (ii) has the this proposed incidental harassment mentioned mitigation, monitoring, and potential to disturb a marine mammal or authorization, as these species are under marine mammal stock in the wild by causing reporting requirements. jurisdiction of the U.S. Fish and disruption of behavioral patterns, including, Dated: June 10, 2003. Wildlife Service (USFWS). EnCana is but not limited to, migration, breathing, nursing, breeding, feeding, or sheltering Donna Wieting, applying for a Letter of Authorization from the USFWS for potential takes of [‘‘Level B harassment’’]. Acting Office Director, Office of Protected Subsection 101(a)(5)(D) establishes a polar bear and Pacific walrus. Resources, National Marine Fisheries Service. 45–day time limit for NMFS review of [FR Doc. 03–15406 Filed 6–17–03; 8:45 am] DATES: Comments and information must an application followed by a 30–day BILLING CODE 3510–22–S be received no later than July 18, 2003. public notice and comment period on ADDRESSES: Comments on the any proposed authorizations for the application should be addressed to Kaja incidental harassment of small numbers Brix, Acting Chief, Marine Mammal of marine mammals. Within 45 days of Conservation Division, Office of the close of the comment period, NMFS Protected Resources, NMFS, 1315 East- must either issue or deny issuance of West Highway, Silver Spring, MD the authorization. 20910–3225. A copy of the application used in this document may be obtained Summary of Request by writing to this address or by On May 14, 2003, NMFS received an telephoning one of the contacts listed application from EnCana requesting an here. authorization for the harassment of

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small numbers of five species of marine the ESA that could potentially be Numbers of Marine Mammals Expected mammals incidental to movement of the affected by these activities. However, to Be Taken SDC from Cross Island, McCovey they are not expected to be encountered The number of marine mammals that Prospect, AK through the Beaufort Sea during the mobilization phase because may be taken as a result of the SDC to Herschel Island, Yukon Territory and the majority of the whales will be at mobilization operation is unpredictable. associated activities beginning on or their summer feeding grounds in Operations are scheduled to occur prior about August 1, 2003 to ice-up later in Canada. However, a few transitory to the westward migration and the year. The SDC will lift-off from its whales may be encountered along the associated subsistence bowhead whale current location and will be towed to routes. Beluga whales occur in the hunts to purposely avoid any take of the new set down location. Once the Beaufort Sea during the summer, but are this species. Noise disturbance from SDC reaches Herschel Island, it will go expected to be found near the pack ice vessels and helicopters or from noise into cold stack mode. Helicopter edge north of the proposed SDC generated from SDC might qualify as supported one-day reconnaissance trips relocation routes. Depending on harassment to seals, but previous to the SDC may occur to check on seasonal ice conditions, it is possible surveys have indicated little behavioral winterization conditions on-board the that belugas may be encountered during reaction from these animals to slow- SDC. A detailed description of these the transit. moving or stationary vessels. activities proposed for 2003–2004 is Based on past surveys, ringed seals contained in the application (Lynx should represent the vast majority of Effects of SDC Mobilization and Enterprises, Inc., 2003), which is marine mammals encountered during Associated Activities on Subsistence available upon request (see ADDRESSES) the transit. Ringed seals are expected to Needs Description of Marine Mammals be present all along the SDC No impact is anticipated on the Affected by the Activity mobilization routes. There is the availability of marine mammal species possibility that bearded and spotted The Beaufort Sea supports many and stocks for subsistence uses since an seals will also be harassed during marine mammals under NMFS amendment to the existing Conflict transit. Spotted seals may be present in jurisdiction, including bowhead whales Avoidance Agreement (CAA) and Plan Prudhoe Bay, but it is likely that they (Balaena mysticetus), beluga of Cooperation has been negotiated with may be closer to shore and therefore are whales(Delphinapterus leucas), ringed the Alaska Eskimo Whaling Commission not expected to be harassed during seals (Phoca hispida), bearded seals (AEWC) and affected village Whaling (Erignathus barbatus) and spotted seals transit phase. Captains Associations. EnCana has (Phoca largha). Descriptions of the It is not likely that bowhead whales taken steps to disclose its project plans biology, distribution, and current status will be impacted by transit operations in initial consultation with the of these species can be found in NMFS since EnCana plans to finish the Executive Director and the president of Stock Assessment Reports (2000, 1999, relocation operations and shutdown the AEWC, the Mayor of the North and 1997). Please refer to those (i.e., cold stack ‘‘quiet’’ mode) the SDC Slope Borough, and village Whaling documents for more information on by late August, when bowhead whales Captains. EnCana coordinated with the these species. These documents can be begin their westward fall migration in AEWC and amended the existing CAA downloaded electronically from: http:// the Beaufort Sea. According to 23 years to include the 2003 SDC relocation. The www.nmfs.noaa.gov/pr/PR2/ of survey data collected by the Minerals operation is scheduled to occur prior to StocklAssessmentlProgram/ Management Service (MMS), North the annual fall bowhead whale hunt. individuallsars.html Slope Borough, the Alaska Eskimo Whaling Commission (AEWC), and Mitigation Potential Effects of SDC Mobilization many more years of traditional During mobilization of the SDC from and Associated Activities on Marine knowledge from Cross Island-based Cross Island at the McCovey Prospect Mammals whale hunters, the annual fall migration through the Beaufort Sea to Herschel Potential harassment of marine of the bowhead whales is normally Island, EnCana will have on-board mammals will result from the noise many kilometers north of the McCovey marine mammal monitors throughout generated by the operation of towing Prospect, where the SDC currently the transit. The program will commence vessels during SDC mobilization resides. However, because the fall with the reoccupation of SDC at the between Cross Island and Herschel migration path of the bowhead whales current McCovey deployment and will Island and the noise generated during is dependent on environmental continue on a nearly 24–hour basis until equipment removal of the SDC. The conditions (i.e., extent of ice coverage) the rig exits U.S. waters and goes into physical presence of the SDC tow that vary from year-to-year, the extreme cold stack mode in Canada. vessels and helicopter could also lead to southern edge of the fall migration EnCana proposes to mitigate the disturbance of marine mammals by corridor may pass closer to McCovey potential negative impacts from its visual or other cues. The potential for Prospect, increasing the likelihood that relocation and supply removal activities collisions between tug vessels and bowhead whales may be harassed by by planning the timing of operations in whales will be reduced by the slow tow activities. Transitory bowhead whales such a way as to reduce the production speed (2 knots) and visual monitoring traveling ahead of the herd may be of noise during the fall bowhead whale by on-board marine mammal observers. encountered during relocation. Beluga migration. This includes putting the Marine mammal species with the whales migrate along the pack ice edge SDC into cold stack mode during the highest likelihood of being harassed north of the proposed relocation routes entire bowhead migration period during the SDC mobilization phase and are not expected to be seen. (approximately late-August through (August) are: beluga whales, ringed mid-October). In addition to these Potential Effects of SDC Mobilization seals, and bearded seals. Spotted seals mitigation measures, EnCana worked and Associated Activities on Habitat are less likely to be harassed during the with the AEWC, North Slope Borough, SDC mobilization phase because they The activity will not result in the and other whaling communities and reside closer to the shore. Bowhead disturbance of any habitat for the amended the existing CAA to include whales are the only species listed under affected species. the 2003 relocation to eliminate impacts

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to subsistence hunting of bowheads and mammals, and the methods, results, and Outer Continental Shelf waters north of thereby on bowheads themselves. interpretation of all monitoring West Dock, and associated activities activities, including estimates of the will result, at worst, in a temporary Monitoring level and type of take, species name and modification in behavior by certain As part of its application, EnCana numbers of each species observed, species of whales and pinnipeds. While proposed a visual monitoring program direction of movement of species, and behavioral modifications may be made for assessing impacts to marine any observed changes or modifications by these species to avoid the resultant mammals during the SDC’s transit from in behavior. noise or visual cues, this behavioral Cross Island, McCovey Prospect to change is expected to have a negligible Endangered Species Act (ESA) Herschel Island or the backup location impact on the survival and recruitment Consultation in Federal Waters north of West Dock of stocks. near Prudhoe Bay, Alaska. The effects of oil and gas exploration While the number of potential EnCana proposes to initiate a activities in the U.S. Beaufort Sea, incidental harassment takes will depend comprehensive training program for all which includes this proposed activity, on the year-to-year distribution and potential marine mammal observers that on listed species were analyzed as part abundance of marine mammals in the includes learning the identification and of a consultation on oil and gas leasing area of operations, due to the behavior of all local species known to and exploration activities in the distribution and abundance of marine use the areas where EnCana will be Beaufort Sea, Alaska, and authorization mammals during the projected period of operating. This training would be of small takes under the MMPA. A activity and the location of the proposed conducted by professional marine biological opinion on these activities activity, the number of potential biologists and experienced Native was issued on May 25, 2001. Pursuant harassment takings is estimated to be observers participating in the to section 7 of the ESA, NMFS has small. In addition, no take by injury monitoring program. The observer begun consultation on the proposed and/or death is anticipated, and there is protocol would be to scan the area issuance of an IHA to EnCana. The only no potential for temporary or permanent around vessels and the SDC with species listed in the ESA that could be hearing impairment as a result of the binoculars of sufficient power. Range taken during these activities are activities. No rookeries, mating grounds, finding equipment will be supplied to bowhead whales. The effects of the areas of concentrated feeding, or other observers in order to better estimate proposed IHA on bowhead whales will areas of special significance for marine distances. Observers would collect data be compared with the analysis mammals occur within or near the on the presence, distribution, and contained in the 2001 biological relocation route. behavior of marine mammals relative to opinion. If an authorization to The principal measures undertaken to EnCana activities as well as climatic incidentally harass marine mammals ensure that the SDC relocation will not conditions at the time of marine listed under the ESA is issued for this have an adverse impact on subsistence mammal sightings. Observations would activity under the MMPA, NMFS will activities is a Conflict Avoidance be made on a nearly 24–hour basis from issue an Incidental Take Statement Agreement (CAA), Plan of Cooperation, the time the SDC leaves Cross Island under section 7 of the ESA. and an operation schedule prior to the until the SDC crosses the Canadian annual bowhead whale subsistence National Environmental Policy Act border or, if the backup deployment in hunt, as amended on June 3, 2003. U.S. waters is used, is placed in cold In 1997, NMFS prepared and released stack mode. If the backup deployment an EA that addressed the impacts on the Proposed Authorization in U.S. waters is used and re-supply human environment from issuance of an NMFS proposes to issue an IHA for efforts are necessary between the end of authorization for taking marine the harassment of marine mammals the fall bowhead whale harvest and ice- mammals incidental to moving an oil incidental to movement of a SDC from over, observers would be re-deployed on drilling structure through the Beaufort Cross Island, McCovey Prospect, AK the SDC and supply vessels. All Sea during the summer and conducting through the Beaufort Sea to Herschel personnel stationed aboard the SDC oil exploration activities in the eastern Island, Yukon Territory, or, as a backup, during the open water season of 2003 Beaufort Sea and the alternatives to that to the U.S. Outer Continental Shelf would also receive training on marine proposed action. A Finding of No waters north of West Dock, and mammal monitoring and utilize marine Significant Impact was signed on associated activities. This IHA proposal mammal reporting forms to document September 25, 1997. Because the action is contingent upon incorporation of the any incidental takes of marine discussed in this document is not previously mentioned mitigation, mammals. substantially different from the 1997 monitoring, and reporting requirements. As required by the MMPA, this action, and because no significant new NMFS has preliminarily determined proposed monitoring plan will be scientific information or analyses have that the proposed activity would result subject to review and approval by been developed in the past several years in the harassment of small numbers of NMFS. significant enough to warrant new bowhead whales, beluga whales, ringed NEPA documentation, this action is seals, bearded seals and spotted seals; Reporting categorically excluded from further would have no more than a negligible All monitoring data collected would review under NOAA Administrative impact on these marine mammal stocks; be reported to NMFS and the USFWS on Order 216–6. A copy of that EA is and would not have an unmitigable a weekly basis. EnCana must provide a available upon request (see ADDRESSES). adverse impact on the availability of final report on 2003–2004 activities to marine mammal stocks for subsistence Preliminary Conclusions NMFS within 90 days of the completion uses once the Plan of Cooperation and of the activity. This report will provide NMFS has preliminarily determined CAA is amended. dates and locations of the SDC that the short-term impact of SDC movements and other operational mobilization from Cross Island, Information Solicited activities, weather conditions, dates and McCovey Prospect, AK through the NMFS requests interested persons to locations of any activities related to Beaufort Sea to Herschel Island, Yukon submit comments, and information, monitoring the effects on marine Territory, or mobilization to the U.S. concerning this request to Kaja Brix,

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Acting Chief, Marine Mammal directed to the Naval Research ENVIRONMENTAL PROTECTION Conservation Division, Office of Laboratory, Code 1004, 4555 Overlook AGENCY Protected Resources, NMFS, 1315 East- Avenue, SW., Washington, DC 20375– [OAR–2003–0078, FRL–7514–6] West Highway, Silver Spring, MD 5320, and must include the Navy Case 20910–3225. number. Agency Information Collection Activities: Proposed Collection; Dated: June 12, 2003. FOR FURTHER INFORMATION CONTACT: Comment Request; Reporting Under Stephen L. Leathery, Catherine M. Cotell, Ph.D., Head, EPA’s Landfill Methane Outreach Acting Office Director, Office of Protected Technology Transfer Office, NRL Code Program Resources, National Marine Fisheries Service. 1004, 4555 Overlook Avenue, SW., [FR Doc. 03–15408 Filed 6–17–03; 8:45 am] Washington, DC 20375–5320, telephone AGENCY: Environmental Protection BILLING CODE 3510–22–S (202) 767–7230. Due to temporary U.S. Agency. Postal Service delays, please fax (202) ACTION: Notice. 404–7920, E-Mail: [email protected] SUMMARY: In compliance with the CONSUMER PRODUCT SAFETY or use courier delivery to expedite Paperwork Reduction Act (44 U.S.C. COMMISSION response. 3501 et seq.), this document announces Sunshine Act Meeting (Authority: 35 U.S.C. 207, 37 CFR Part 404.) that EPA is planning to submit the following continuing Information AGENCY: Consumer Product Safety Dated: June 11, 2003. Collection Request (ICR) to the Office of Commission, Washington, DC 20207. E.F. McDonnell, Management and Budget (OMB): TIME AND DATE: Tuesday, June 24, 2003, Major, U.S. Marine Corps, Federal Register Reporting Under EPA’s Landfill 2 p.m. Liaison Officer. Methane Outreach Program, ICR LOCATION: Room 410, Bethesda Towers, [FR Doc. 03–15321 Filed 6–17–03; 8:45 am] Number 1849.02, OMB Control Number 4330 East West Highway, Bethesda, BILLING CODE 3810–FF–P 2060–0446, expiration October 31, 2003. Maryland. Before submitting the ICR to OMB for STATUS: Closed to the Public—Pursuant review and approval, EPA is soliciting to 5 U.S.C. 552b(f)(1) and 16 CFR DEPARTMENT OF DEFENSE comments on specific aspects of the 1013.4(b)(3), (7), (9), and (10) and proposed information collection as submitted to the Federal Register Department of the Navy described below. pursuant to 5 U.S.C. 552b(e)(3). Notice of Availability of Government- DATES: Comments must be submitted on MATTER TO BE CONSIDERED: The staff will or before August 18, 2003. brief the Commission on the status of Owned Invention; Available for Licensing ADDRESSES: Follow the detailed various compliance matters. instructions in SUPPLEMENTARY For a recorded message containing the INFORMATION. latest agenda information, call (301) AGENCY: Department of the Navy, DoD. FOR FURTHER INFORMATION CONTACT: 504–7948. ACTION: Notice. FOR FURTHER INFORMATION CONTACT: Brian Guzzone, Climate Protection Todd A. Stevenson, Office of the Partnerships Division, Office of SUMMARY: The invention listed below is Atmospheric Programs, 6202J, Secretary, 4330 East West Highway, assigned to the United States Bethesda, MD 20207, (301) 504–7923. Environmental Protection Agency, 1200 Government as represented by the Pennsylvania Ave., NW., Washington, Dated: June 16, 2003. Secretary of the Navy and is available DC 20460; telephone number: (202) Todd A. Stevenson, for licensing by the Department of the 564–2666; fax number: (202) 565–2079; Secretary. Navy. U.S. Patent No. 6,459,079 B1 e-mail address: [email protected]. [FR Doc. 03–15546 Filed 6–16–03; 4:01 p.m.] entitled, ‘‘SHIPBOARD CHEMICAL SUPPLEMENTARY INFORMATION: EPA has BILLING CODE 6335–01–M AGENT MONITOR—PORTABLE established a public docket for this ICR (SCAMP).’’ under Docket ID number OAR–2003– 0078, which is available for public ADDRESSES: Requests for copies of the DEPARTMENT OF DEFENSE viewing at the Air and Radiation Docket patent cited should be directed to the in the EPA Docket Center (EPA/DC), Department of the Navy Naval Surface Warfare Center, Dahlgren EPA West, Room B102, 1301 Div., Code XDC1, 17320 Dahlgren Rd., Constitution Ave., NW., Washington, Notice of Availability of Government- Dahlgren, VA 22448–5100. DC. The EPA Docket Center Public Owned Invention; Available for Reading Room is open from 8:30 a.m. to Licensing FOR FURTHER INFORMATION CONTACT: Matthew J. Bussan, Patent Counsel, 4:30 p.m., Monday through Friday, AGENCY: Department of the Navy, DoD. Naval Surface Warfare Center, Dahlgren excluding legal holidays. The telephone ACTION: Notice. Div., Code XDC1, 17320 Dahlgren Rd., number for the Reading Room is (202) Building 183, Room 4, Dahlgren, VA 566–1744, and the telephone number for SUMMARY: The invention listed below is 22448–5100, telephone (540) 653–8061. the Air and Radiation Docket is (202) assigned to the United States 566–1742. An electronic version of the Government as represented by the (Authority: 35 U.S.C. 207, 37 CFR Part 404.) public docket is available through EPA Secretary of the Navy and is available Dated: June 11, 2003. Dockets (EDOCKET) at http:// for licensing by the Department of the E.F. McDonnell, www.epa.gov/edocket. Use EDOCKET to Navy. Navy Case No. 82,897, entitled obtain a copy of the draft collection of ‘‘Anti-Charging Layer for Beam Major, U.S. Marine Corps, Federal Register information, submit or view public Liaison Officer. Lithography and Mask Fabrication.’’ comments, access the index listing of [FR Doc. 03–15322 Filed 6–17–03; 8:45 am] ADDRESSES: Requests for information the contents of the public docket, and to about the invention cited should be BILLING CODE 3810–FF–P access those documents in the public

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docket that are available electronically. promote the use of landfill methane at or provide information to or for a Once in the system, select ‘‘search,’’ their facilities. The Landfill Methane Federal agency. This includes the time then key in the docket ID number Outreach Program signs voluntary needed to review instructions; develop, identified above. Memoranda of Understanding (MOU) acquire, install, and utilize technology Any comments related to this ICR with these organizations to enlist their and systems for the purposes of should be submitted to EPA within 60 support in promoting cost-effective collecting, validating, and verifying days of this notice, and according to the landfill gas utilization. The information information, processing and following detailed instructions: Submit collection includes completion and maintaining information, and disclosing your comments to EPA online using submission of the MOU, and annual and providing information; adjust the EDOCKET (our preferred method), by e- online completion and submission of existing ways to comply with any mail to a-and-r- information forms that include basic previously applicable instructions and [email protected], or by mail to: information on the organizations that requirements; train personnel to be able EPA Docket Center, Environmental sign the MOU and landfill methane to respond to a collection of Protection Agency, Air and Radiation projects in which they are involved. The information; search data sources; Docket and Information Center, MC information collection is to be utilized complete and review the collection of 6102T, 1200 Pennsylvania Ave., NW., to maintain up-to-date data and information; and transmit or otherwise Washington, DC 20460. information about Landfill Methane disclose the information. EPA’s policy is that public comments, Outreach Program partners and landfill Dated: May 29, 2003. whether submitted electronically or in methane projects in which they are paper, will be made available for public involved. In addition, the information Kathleen Hogan, viewing in EDOCKET as EPA receives collection will assist LMOP to evaluate Director. them and without change, unless the the reduction of methane emissions [FR Doc. 03–15362 Filed 6–17–03; 8:45 am] comment contains copyrighted material, from landfills. Responses to the BILLING CODE 6560–50–P CBI, or other information whose public information collection are voluntary. disclosure is restricted by statute. When An agency may not conduct or EPA identifies a comment containing sponsor, and a person is not required to ENVIRONMENTAL PROTECTION copyrighted material, EPA will provide respond to, a collection of information AGENCY a reference to that material in the unless it displays a currently valid OMB [FRL–7514–8] version of the comment that is placed in control number. The OMB control EDOCKET. The entire printed comment, numbers for EPA’s regulations are listed Technical Peer Review Meeting on the including the copyrighted material, will in 40 CFR part 9 and 48 CFR chapter 15. Draft Document Entitled, Exposure and be available in the public docket. The EPA would like to solicit Human Health Evaluation of Airborne Although identified as an item in the comments to: Pollution from the World Trade Center official docket, information claimed as (i) Evaluate whether the proposed Disaster CBI, or whose disclosure is otherwise collection of information is necessary restricted by statute, is not included in for the proper performance of the AGENCY: Environmental Protection the official public docket, and will not functions of the agency, including Agency. be available for public viewing in whether the information will have ACTION: Notice of meeting. EDOCKET. For further information practical utility; SUMMARY: about the electronic docket, see EPA’s (ii) Evaluate the accuracy of the The U.S. Environmental Federal Register notice describing the agency’s estimate of the burden of the Protection Agency (EPA) is announcing electronic docket at 67 FR 38102 (May proposed collection of information, a technical peer review meeting, 31, 2002), or go to www.epa.gov./ including the validity of the organized and convened by Versar, Inc., edocket. methodology and assumptions used; a contractor to the National Center for Affected Entities: Entities potentially (iii) Enhance the quality, utility, and Environmental Assessment (NCEA) affected by this action are those local clarity of the information to be within EPA’s Office of Research and agencies and municipalities that own collected; and Development, for review of the draft landfills; State agencies; manufacturers (iv) Minimize the burden of the document entitled, Exposure and and suppliers of equipment/knowledge collection of information on those who Human Health Evaluation of Airborne to capture and utilize landfill gas; utility are to respond, including through the Pollution from the World Trade Center companies; end users of energy from the use of appropriate automated electronic, Disaster (EPA/600/P–02/002A). The landfill. mechanical, or other technological document was prepared by NCEA. The Title: Reporting Under EPA’s Landfill collection techniques or other forms of draft document was already subjected to Methane Outreach Program (OMB information technology, e.g., permitting public review and comment. NCEA will Control Number 2060–0446; EPA ICR electronic submission of responses. consider those public comments and Number 1849.02; expiring October 31, Burden Statement: The annual public any additional comments provided by 2003). reporting and recordkeeping burden for the expert peer-review panel in revising Abstract: The Landfill Methane this (3) three year collection of the document. Outreach Program (LMOP) is an EPA- information is estimated to equal 1,531 DATES: The peer review meeting will be sponsored voluntary program that hours and to average 3.6 hours per year held on Monday, July 14 and Tuesday, encourages landfill owners, per respondent. The estimated number July 15, 2003, from 9 a.m. to 5 p.m., communities, and project developers to of respondents averaged over (3) three eastern daylight time (EDT) each day. reduce emissions of methane, a potent years is 422. The average capital, start- On December 27, 2002, the draft report greenhouse gas, by implementing up, and operation and maintenance cost was announced in the Federal Register landfill gas technologies that collect and resulting from this three year collection (67 FR 79079) and made available for a utilize the methane as a source of of information is $212 per respondent. 60-day public comment period that energy. The Landfill Methane Outreach Burden means the total time, effort, or ended on February 25, 2003. The Program further encourages utilities and financial resources expended by persons comment period was subsequently other energy customers to support and to generate, maintain, retain, or disclose extended (Federal Register (68 FR

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10723) dated March 6, 2003) until April pollutants resulting from the World decision to add 52 water quality limited 7, 2003. Copies of the public comments Trade Center disaster was initiated. This segments (WQLSs) and associated received by EPA have been provided to draft evaluation is the subject of the pollutants to Arkansas’ 2002 303(d) list. the expert peer reviewers. technical peer review meeting ADDRESSES: Copies of the documents ADDRESSES: The meeting will be held at announced today. The primary purpose the Sofitel New York Hotel, 45 West and scope of the draft report were to which explain the rationale for EPA’s 44th Street, New York, NY 10036; evaluate the environmental levels of final decision, response to public telephone (212) 354–8844. Versar, Inc., various air pollutants to which the comments, and a list of the 50 WQLSs an EPA contractor, will convene and public could potentially be exposed as that EPA added to Arkansas’ 2002 facilitate the meeting. To attend the a result of the collapse of the towers. section 303(d) list can be obtained from meeting as an observer, register by July These data were evaluated in terms of EPA Region 6’s Web site at 10, 2003, 5 p.m. EDT by visiting http:/ available health benchmark www.epa.gov/earth1r6/6wq/artmdl.htm, /www.versar.com/epa/ concentrations and typical background or by writing or calling Ms. Ellen wtcpeerreview.htm or contacting Ms. concentrations for New York City or Caldwell, Environmental Protection Traci Bludis, Versar, Inc.; telephone: other urban areas. The draft evaluation Specialist, Water Quality Protection (703) 750–3000, extension 449; concludes that, with the exception of Division, U.S. Environmental Protection facsimile: (703) 642–6954; e-mail: those exposed immediately following Agency Region 6, 1445 Ross Ave., [email protected]. There will be a the collapse and perhaps during the Dallas, TX 75202–2733, telephone (214) limited time for oral comments from the next few days, people in the 665–7513, facsimile (214) 665–6490, or public (registration is required). If you surrounding community are not likely e-mail: [email protected]. wish to make a statement during the to suffer from serious long- or short-term Documents from the administrative observer comment period of the health effects. While the primary focus record for these decisions also are workshop, please check the appropriate of EPA’s draft evaluation is on outdoor available for public inspection at the box when you register at the Web site. levels of various air pollutants to which above address. Please contact Ms. Space is limited, and registration for the public could potentially be exposed Caldwell to schedule an inspection. attendance and oral comments will be as a result of the collapse of the towers, accepted on a first-come, first-served some information on indoor and FOR FURTHER INFORMATION CONTACT: basis. occupational exposures is summarized Ellen Caldwell at (214) 665–7513. in EPA’s draft report. FOR FURTHER INFORMATION CONTACT: For SUPPLEMENTARY INFORMATION: Section Both the processes of public review workshop information and logistics 303(d) of the Clean Water Act (CWA) and comment and expert scientific peer please contact Versar, Inc. The draft requires that each state identify those document, Exposure and Human Health review are the usual steps that EPA waters for which existing technology- Evaluation of Airborne Pollution from takes to ensure full and open based pollution controls are not the World Trade Center Disaster, is participation by interested parties. available via the Internet on the NCEA These steps help EPA identify areas stringent enough to attain or maintain Web site at http://www.epa.gov/ncea/ where a draft document could be state water quality standards. For those wtc.htm. Copies are not available from improved to strengthen both clarity and waters, states are required to establish Versar, Inc. For information regarding completeness of the draft. Comments total maximum daily loads according to the draft document, please contact from the public and from the expert a priority ranking. Linda C. Tuxen, U.S. Environmental peer reviewers during this meeting will On March 10, 2003, EPA approved Protection Agency, Office of Research be used to improve the draft report Arkansas’ listing of 76 WQLSs and and Development, National Center for before it is finalized. associated priority rankings. EPA Environmental Assessment (8601–D), Dated: June 12, 2003. disapproved Arkansas’ decision not to Washington, DC 20460; telephone: (202) George W. Alapas, list 52 WQLSs and associated 564–3332; fax: (202) 565–0090; e-mail: Deputy Director, National Center for pollutants. EPA proposed to add 52 of [email protected]. Environmental Assessment. these additional WQLSs and pollutants SUPPLEMENTARY INFORMATION: [FR Doc. 03–15364 Filed 6–17–03; 8:45 am] along with priority rankings for Immediately following the September BILLING CODE 6560–50–P inclusion on the 2002 Section 303(d) list 11, 2001, terrorist attack on New York and initiated public notice and City’s World Trade Center, many federal comment for these proposed listings. agencies, including the EPA, were ENVIRONMENTAL PROTECTION On June 9, 2003, EPA took final called upon to focus their technical and AGENCY scientific expertise on the national agency action not adding two of the emergency issues. EPA, other federal [FRL–7514–4] proposed additional WQLSs and agencies, New York City, and New York associated pollutants to the Arkansas Clean Water Act Section 303(d): Final 2002 section 303(d) list and adding 50 State public health and environmental Agency Action Adding Waters to the WQLSs to the Arkansas 2002 section authorities focused on numerous air Arkansas 2002 Section 303(d) List monitoring activities to better 303(d) list. understand the ongoing human health AGENCY: Environmental Protection Dated: June 9, 2003. impact of the disaster. Many EPA offices Agency. Miguel I. Flores, and programs quickly became involved ACTION: Final agency action. with these activities, providing Director, Water Quality Protection Division, Region 6. scientific, engineering, public health, SUMMARY: This notice announces EPA’s and management expertise to help cope final agency action on the Arkansas [FR Doc. 03–15254 Filed 6–17–03; 8:45 am] with the aftereffects of the collapse of 2002 section 303(d) list pursuant to BILLING CODE 6560–60–P the World Trade Center. Clean Water Act section 303(d). As part of these activities, a human On June 9, 2003, EPA took final action health evaluation of exposure to air on its March 10, 2003, proposed

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ENVIRONMENTAL PROTECTION Section (6WQ–SD), 1445 Ross Avenue, transaction by e-mail to AGENCY Suite 1200, Dallas, Texas 75202. [email protected] or by mail FOR FURTHER INFORMATION CONTACT: to 811 Vermont Avenue, NW., Room [FRL–7514–3] David Reazin, EPA Region 6, Drinking 1238, Washington, DC 20571, within 14 Public Water System Supervision Water Section at the Dallas address days of the date this notice appears in Program Revision for the State of given above or at telephone (214) 665– the Federal Register. Louisiana 7501, or [email protected]. Helene S. Walsh, Authority: (Sec. 1413 of the Safe Drinking Director, Policy Oversight and Review. AGENCY: Environmental Protection Water Act, as amended (1996), and 40 CFR [FR Doc. 03–15346 Filed 6–17–03; 8:45 am] Agency (EPA). part 142 of the National Primary Drinking BILLING CODE 6690–01–M ACTION: Notice of tentative approval. Water Regulations). Dated: June 9, 2003. SUMMARY: Notice is hereby given that Richard E. Greene, the State of Louisiana is revising its FEDERAL COMMUNICATIONS approved Public Water System Regional Administrator, Region 6. COMMISSION [FR Doc. 03–15255 Filed 6–17–03; 8:45 am] Supervision Program. Louisiana has [CC Docket No. 96–45; DA 03–1881] revised its administrative penalty BILLING CODE 6560–50–P authority, revised its definition for Wireline Competition Bureau Seeks public water system, and adopted a Comment on ALLTEL consumer confidence report rule for all EXPORT-IMPORT BANK Communications, Inc. Petition for community water systems. EPA has Designation as an Eligible determined that these revisions are no Economic Impact Policy Telecommunications Carrier in the less stringent than the corresponding This notice is to inform the public State of Virginia federal regulations. Therefore, EPA that the Export-Import Bank has AGENCY: Federal Communications intends to approve these program received an application to guarantee up Commission. revisions. All interested parties may to $198 million of equipment and other request a public hearing. A request for goods and services on the behalf of U.S. ACTION: Notice; solicitation of a public hearing must be submitted by exporters to a buyer in Egypt. The U.S. comments. July 18, 2003, to the Regional exports will enable the Egyptian SUMMARY: In this document, the Administrator at the EPA Region 6 company to produce anhydrous Wireline Competition Bureau sought address shown below. Frivolous or ammonia from natural gas. The Egyptian comment on the ALLTEL Petition. insubstantial requests for a hearing may company will have a production ALLTEL Communications, Inc. be denied by the Regional capacity of 1,850 metric tons of (ALLTEL) is seeking designation as an Administrator. However, if a substantial ammonia per day. It is envisioned this eligible telecommunications carrier request for a public hearing is made by new production will be consumed (ETC) to receive federal universal July 18, 2003, a public hearing will be primarily in Jordan and India. Interested service support for service offered held. If no timely and appropriate parties may submit comments on this throughout its licensed service area in request for a hearing is received and the transaction by e-mail to the state of Virginia, including rural and Regional Administrator does not elect to [email protected] or by mail non-rural areas. hold a hearing on his own motion, this to 811 Vermont Avenue, NW., Room DATES: Comments are due on or before determination shall become final and 1238, Washington, DC 20571, within 14 June 30, 2003. Reply comments are due effective on July 18, 2003. Any request days of the date this notice appears in on or before July 7, 2003. for a public hearing shall include the the Federal Register. following information: The name, ADDRESSES: Federal Communications address, and telephone number of the Helene S. Walsh, Commission, 445 Twelfth Street, SW., individual, organization, or other entity Director, Policy Oversight and Review. Washington, DC 20554. See requesting a hearing; a brief statement of [FR Doc. 03–15345 Filed 6–17–03; 8:45 am] SUPPLEMENTARY INFORMATION for further the requesting person’s interest in the BILLING CODE 6690–01–M filing instructions. Regional Administrator’s determination FOR FURTHER INFORMATION CONTACT: and a brief statement of the information Shannon Lipp, Attorney, Wireline that the requesting person intends to EXPORT-IMPORT BANK Competition Bureau, submit at such hearing; and the Telecommunications Access Policy signature of the individual making the Economic Impact Policy Division, (202) 418–7400, TTY (202) request, or, if the request is made on This notice is to inform the public 418–0494. behalf of an organization or other entity, that the Export-Import Bank has SUPPLEMENTARY INFORMATION: This is a the signature of a responsible official of received an application to guarantee up summary of the Commission’s Public the organization or other entity. to $25 million of equipment and other Notice, CC Docket No. 96–45, released ADDRESSES: All documents relating to goods and services on the behalf of U.S. June 3, 2003. On April 14, 2003, this determination are available for exporters to a buyer in Mexico. The U.S. ALLTEL Communications, Inc. inspection between the hours of 8 a.m. exports will enable the Mexican (ALLTEL), a commercial mobile radio and 4:30 p.m., Monday through Friday, company to produce non-automotive service (CMRS) carrier, filed with the at the following offices: Louisiana flat glass. The Mexican company will Commission a petition under section Department of Health and Hospitals, produce 146,000 metric tons of glass 214(e)(6) seeking designation as an Engineering Services, Safe Drinking with a thickness between 2.4 and 8.0 eligible telecommunications carrier Water Program, 6867 Bluebonnet Drive, mm. It is envisioned this new (ETC) to receive federal universal Baton Rouge, LA 70810 and the United production will be consumed in Mexico service support for service offered States Environmental Protection and the United States. Interested parties throughout its licensed service area in Agency, Region 6, Drinking Water may submit comments on this the state of Virginia, including rural and

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non-rural areas. On May 21, 2003, commenters should include their full Federal Communications Commission. ALLTEL filed an amendment to its name, U.S. Postal Service mailing Paul Garnett, petition with regard to its proposed address, and the applicable docket or Acting Assistant Division Chief, Wireline service areas. Specifically, ALLTEL rulemaking number. Parties may also Competition Bureau, Telecommunications contends that: the Virginia State submit an electronic comment by Access Policy Division. Corporation Commission (Virginia Internet e-mail. To get filing instructions [FR Doc. 03–15303 Filed 6–17–03; 8:45 am] Commission) has provided an for e-mail comments, commenters BILLING CODE 6712–01–P affirmative statement that it does not should send an e-mail to [email protected], regulate CMRS carriers; ALLTEL and should include the following words satisfies all the statutory and regulatory in the body of the message, ‘‘get form FEDERAL COMMUNICATIONS prerequisites for ETC designation; and .’’ A sample form COMMISSION designating ALLTEL as an ETC will and directions will be sent in reply. [CC Docket No. 96–45; DA 03–1882] serve the public interest. Parties who choose to file by paper Pursuant to § 54.207(c) of the Wireline Competition Bureau Seeks Commission’s rules, ALLTEL also must file an original and four copies of each filing. If more than one docket or Comment on ALLTEL requests that the Commission designate Communications, Inc. Petition for rulemaking number appears in the ALLTEL as an ETC in service areas Designation as an Eligible caption of this proceeding, commenters defined along boundaries that differ Telecommunications Carrier in the must submit two additional copies for from incumbent rural local exchange State of Alabama company (LEC) study area boundaries. each additional docket or rulemaking ALLTEL requests that these service number. Filings can be sent by hand or AGENCY: Federal Communications areas be redefined on a wire center by messenger delivery, by commercial Commission. wire center basis such that each wire overnight courier, or by first-class or ACTION: Notice; solicitation of center is a separate service area. overnight U.S. Postal Service mail comments. ALLTEL intends to serve each proposed (although we continue to experience wire center in its entirety. The service delays in receiving U.S. Postal Service SUMMARY: In this document, the area requested by ALLTEL for ETC mail). The Commission’s contractor, Wireline Competition Bureau sought designation partially covers the study Vistronix, Inc., will receive hand- comment on the ALLTEL Petition. areas of Central Telephone Company— delivered or messenger-delivered paper ALLTEL Communications, Inc. Virginia and United Inter-Mountain filings for the Commission’s Secretary at (ALLTEL) is seeking designation as an Telephone. ALLTEL maintains that the 236 Massachusetts Avenue, NE., Suite eligible telecommunications carrier proposed redefinition of service areas 110, Washington, DC 20002. The filing (ETC) to receive federal universal for ETC purposes is consistent with the hours at this location are 8 a.m. to 7 service support for service offered factors to be considered when p.m. All hand deliveries must be held throughout its licensed service area in redefining a rural telephone company together with rubber bands or fasteners. the state of Alabama, including rural service area, as enumerated by the Any envelopes must be disposed of and non-rural areas. Federal-State Joint Board on Universal before entering the building. DATES: Comments are due on or before Service (Joint Board). Commercial overnight mail (other than June 30, 2003. Reply comments are due The petitioner must provide copies of on or before July 7, 2003. its petition to the Virginia Commission. U.S. Postal Service Express Mail and ADDRESSES: Federal Communications The Commission will also send a copy Priority Mail) must be sent to 9300 East Hampton Drive, Capitol Heights, MD Commission, 445 Twelfth Street, SW., of this Public Notice to the Virginia Washington, DC 20554. See Commission by overnight express mail 20743. U.S. Postal Service first-class SUPPLEMENTARY INFORMATION for further to ensure that the Virginia Commission mail, Express Mail, and Priority Mail filing instructions. is notified of the notice and comment should be addressed to 445 12th Street, period. SW., Washington, DC 20554. All filings FOR FURTHER INFORMATION CONTACT: Pursuant to §§ 1.415 and 1.419 of the must be addressed to the Commission’s Shannon Lipp, Attorney, Wireline Commission’s rules, interested parties Secretary, Marlene H. Dortch, Office of Competition Bureau, may file comments as follows: the Secretary, Federal Communications Telecommunications Access Policy comments are due on or before June 30, Commission. Division, (202) 418–7400, TTY (202) 418–0494. 2003, and reply comments are due on or Parties also must send three paper before July 7, 2003. Comments may be copies of their filing to Sheryl Todd, SUPPLEMENTARY INFORMATION: This is a filed using the Commission’s Electronic Telecommunications Access Policy summary of the Commission’s Public Comment Filing System (ECFS) or by Division, Wireline Competition Bureau, Notice, CC Docket No. 96–45, released filing paper copies. See Electronic Filing Federal Communications Commission, June 3, 2003. On April 14, 2003, ALLTEL Communications, Inc. of Documents in Rulemaking 445 12th Street SW., Room 5–B540, (ALLTEL), a commercial mobile radio Proceedings, 63 FR 24121, May 1, 1998. Washington, DC 20554. In addition, Comments filed through the ECFS can service (CMRS) carrier, filed with the commenters must send diskette copies be sent as an electronic file via the Commission a petition under section to the Commission’s copy contractor, Internet to http://www.fcc.gov/e-file/ 214(e)(6) seeking designation as an Qualex International, Portals II, 445 ecfs.html. Generally, only one copy of eligible telecommunications carrier an electronic submission must be filed. 12th Street, SW., Room CY-B402, (ETC) to receive federal universal If multiple docket or rulemaking Washington, DC 20054. service support for service offered numbers appear in the caption of this Pursuant to § 1.1206 of the throughout its licensed service area in proceeding, however, commenters must Commission’s rules, 47 CFR 1.1206, this the state of Alabama, including rural transmit one electronic copy of the proceeding will be conducted as a and non-rural areas. On May 21, 2003, comments to each docket or rulemaking permit-but-disclose proceeding in ALLTEL filed an amendment to its number referenced in the caption. In which ex parte communications are petition with regard to its proposed completing the transmittal screen, permitted subject to disclosure. service areas. Specifically, ALLTEL

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contends that: the Alabama Public an electronic submission must be filed. Pursuant to § 1.1206 of the Service Commission (Alabama If multiple docket or rulemaking Commission’s rules, 47 CFR 1.1206, this Commission) has provided an numbers appear in the caption of this proceeding will be conducted as a affirmative statement that it does not proceeding, however, commenters must permit-but-disclose proceeding in regulate CMRS carriers; ALLTEL transmit one electronic copy of the which ex parte communications are satisfies all the statutory and regulatory comments to each docket or rulemaking permitted subject to disclosure. prerequisites for ETC designation; and number referenced in the caption. In Federal Communications Commission. designating ALLTEL as an ETC will completing the transmittal screen, serve the public interest. commenters should include their full Paul Garnett, Pursuant to § 54.207(c) of the name, U.S. Postal Service mailing Acting Assistant Division Chief, Wireline Commission’s rules, ALLTEL also address, and the applicable docket or Competition Bureau, Telecommunications Access Policy Division. requests that the Commission designate rulemaking number. Parties may also ALLTEL as an ETC in service areas submit an electronic comment by [FR Doc. 03–15304 Filed 6–17–03; 8:45 am] defined along boundaries that differ Internet e-mail. To get filing instructions BILLING CODE 6712–01–P from incumbent rural local exchange for e-mail comments, commenters company (LEC) study area boundaries. should send an e-mail to [email protected], ALLTEL requests that these service and should include the following words FEDERAL ELECTION COMMISSION areas be redefined on a wire center by in the body of the message, ‘‘get form Sunshine Act Meeting wire center basis such that each wire .’’ A sample form center is a separate service area. and directions will be sent in reply. AGENCY: Federal Election Commission. ALLTEL intends to serve each proposed Parties who choose to file by paper wire center in its entirety. The service DATE AND TIME: Monday, June 23, 2003 must file an original and four copies of at 10 a.m. areas requested by ALLTEL for ETC each filing. If more than one docket or designation partially cover the study PLACE: 999 E Street, NW., Washington, rulemaking number appears in the DC. areas of ALLTEL Alabama, Inc. (a caption of this proceeding, commenters wireline affiliate of ALLTEL by virtue of must submit two additional copies for STATUS: This meeting will be closed to common ownership by ALLTEL each additional docket or rulemaking the public. Corporation), Butler Telephone Co. Inc., number. Filings can be sent by hand or ITEMS TO BE DISCUSSED: Castleberry Telephone Co. Inc., Frontier messenger delivery, by commercial Compliance matters pursuant to 2 Communications of Alabama, Frontier overnight courier, or by first-class or U.S.C. 437g. Communications of The South, Graceba overnight U.S. Postal Service mail Audits conducted pursuant to 2 Total Communications, GTC Inc.—AL, (although we continue to experience U.S.C. 437g, 438(b), and title 26, U.S.C. Gulf Telephone Co., Hayneville delays in receiving U.S. Postal Service Matters concerning participation in Telephone Co. Inc., Millry Telephone mail). The Commission’s contractor, civil actions or proceedings or Company, Mon-Cre Telephone Vistronix, Inc., will receive hand- arbitration. Cooperative, Pine Belt Telephone delivered or messenger-delivered paper Internal personnel rules and Company, Union Springs Telephone Co. filings for the Commission’s Secretary at procedures or matters affecting a Inc. ALLTEL maintains that the 236 Massachusetts Avenue, NE., Suite particular employee. proposed redefinition of service areas for ETC purposes is consistent with the 110, Washington, DC 20002. The filing DATE AND TIME: Thursday, June 26, 2003 factors to be considered when hours at this location are 8 a.m. to 7 at 10 a.m. redefining a rural telephone company p.m. All hand deliveries must be held PLACE: 999 E Street, NW., Washington, service area, as enumerated by the together with rubber bands or fasteners. DC (ninth floor). Any envelopes must be disposed of Federal-State Joint Board on Universal STATUS: This meeting will be open to the before entering the building. Service (Joint Board). public. Commercial overnight mail (other than The petitioner must provide copies of ITEMS TO BE DISCUSSED: its petition to the Alabama Commission. U.S. Postal Service Express Mail and Priority Mail) must be sent to 9300 East Correction and Approval of Minutes. The Commission will also send a copy Draft Advisory Opinion 2003–05— of this Public Notice to the Alabama Hampton Drive, Capitol Heights, MD 20743. U.S. Postal Service first-class National Association of Homebuilders Commission by overnight express mail of the United States by counsel, Mark to ensure that the Alabama Commission mail, Express Mail, and Priority Mail should be addressed to 445 12th Street, Braden. is notified of the notice and comment Routine Administrative Matters. period. SW., Washington, DC 20554. All filings Pursuant to §§ 1.415 and 1.419 of the must be addressed to the Commission’s FOR FURTHER INFORMATION CONTACT: Mr. Commission’s rules, 47 CFR 1.415, Secretary, Marlene H. Dortch, Office of Ron Harris, Press Officer, Telephone: 1.419, interested parties may file the Secretary, Federal Communications (202) 694–1220. comments as follows: comments are due Commission. Mary W. Dove, on or before June 30, 2003, and reply Parties also must send three paper Secretary of the Commission. comments are due on or before July 7, copies of their filing to Sheryl Todd, [FR Doc. 03–15544 Filed 6–16–03; 2:16 pm] 2003. Comments may be filed using the Telecommunications Access Policy BILLING CODE 6715–01–M Commission’s Electronic Comment Division, Wireline Competition Bureau, Filing System (ECFS) or by filing paper Federal Communications Commission, copies. See Electronic Filing of 445 12th Street SW., Room 5–B540, FEDERAL MARITIME COMMISSION Documents in Rulemaking Proceedings, Washington, DC 20554. In addition, 63 FR 24121, May 1, 1998. commenters must send diskette copies Notice of Agreement(s) Filed Comments filed through the ECFS can to the Commission’s copy contractor, be sent as an electronic file via the Qualex International, Portals II, 445 The Commission hereby gives notice Internet to http://www.fcc.gov/e-file/ 12th Street, SW., Room CY–B402, of the filing of the following ecfs.html. Generally, only one copy of Washington, DC 20054. agreement(s) under the Shipping Act of

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1984. Interested parties can review or Title: Common Ocean Carrier Platform Agreement No.: 011802–003. obtain copies of agreements at the Agreement (INTTRA). Title: Evergreen/Lloyd Triestino/ Washington, DC, offices of the Parties: A.P. Moller-Maersk Sealand, Hatsu Marine Alliance—WTSA Bridging P&O Nedlloyd Limited, Hamburg- Commission, 800 North Capitol Street, Agreement. NW., Room 940. Interested parties may Su¨ damerikanische submit comments on an agreement to Dampfschifffahrtgesellschaft KG, Parties: Evergreen Marine Corp. the Secretary, Federal Maritime Mediterranean Shipping Company, (Taiwan) Ltd.; Lloyd Triestino di Commission, Washington, DC 20573, CMA CGM, Hapag-Lloyd Container Navegazione S.p.A.; Hatsu Marine within 10 days of the date this notice Linie, United Arab Shipping Company, Limited; AmericanPresident Lines, Ltd. appears in the Federal Register. Alianca Navegac¸ao e Logistica Ltda., and APL Co. Pte Ltd. (operating as one Agreement No.: 011284–052. Safmarine Container Lines, Nippon carrier); China Shipping Container Lines Title: Ocean Carrier Equipment Yusen Kaisha, and CP Ships Limited for Co., Ltd.; COSCO Container Lines Ltd.; Management Association. its ocean common carrier subsidiaries. Hanjin Shipping Co., Ltd.; Hapag-Lloyd Parties: APL Co. PTE Ltd; American Synopsis: The modification adds Container Linie GmbH; Hyundai President Lines Ltd; A.P. Moller-Maersk Tasman Orient Line C.V. as a non- Merchant Marine Co., Ltd.; Kawasaki Sealand; CMA CGM, S.A.; Compania shareholder party to the agreement. Kisen Kaisha, Ltd.; Mitsui O.S.K. Lines, Sud Americana de Vapores, S.A.; Agreement No.: 011770–002. Ltd.; Nippon Yusen Kaisha; Orient Evergreen Marine Corp. (Taiwan) Ltd.; Title: NSCSA/Oldendorff Slot Overseas Container Line Limited; P&O Hanjin Shipping Co., Ltd.; Hamburg- Exchange Agreement. Parties: National Shipping Company Nedlloyd B.V.; P&O Nedlloyd Limited; Su¨ damerikanische Yangming Marine Transport Corp. Dampfschifffahrtgesellschaft KG; Hapag- of Saudi Arabia, Oldendorff Carriers Synopsis: The proposed amendment Lloyd Container Linie GmbH; Hyundai (Indotrans) Ltd. Synopsis: The proposed modification Merchant Marine Co., Ltd.; Mitsui would extend the duration of agreement reduces the scope of the agreement to O.S.K. Lines, Ltd.; Lykes Lines Limited, through August 15, 2004. the westbound trade from ports in India LLC; TMM Lines Limited, LLC; Dated: June 13, 2003. to U.S. East and Gulf Coast ports; revises Contship Container Lines, a division of the amount of space to be chartered; and By Order of the Federal Maritime CP Ships (UK) Limited; Australia-New revises agreement provisions on Commission. Zealand Direct Line, a division of CP termination, notices, and force majeure. Bryant L. VanBrakle, Ships (UK) Limited; Orient Overseas Agreement No.: 011799–002. Secretary. Container Line Limited; P&O Nedlloyd Title: Evergreen/Lloyd Triestino/ B.V.; P&O Nedlloyd Limited; Nippon [FR Doc. 03–15390 Filed 6–17–03; 8:45 am] Hatsu Marine Alliance—TSA Bridging BILLING CODE 6730–01–P Yusen Kaisha Line; Yangming Marine Agreement. Transport Corp.; COSCO Container Parties: Evergreen Marine Corp. Lines Company Limited; and Kawasaki (Taiwan) Ltd.; Lloyd Triestino di FEDERAL MARITIME COMMISSION Kisen Kaisha, Ltd. Navegazione S.p.A.; Hatsu Marine Synopsis: The amendment adds Limited; AmericanPresident Lines, Ltd. Crowley Maritime Corporation to the Ocean Transportation Intermediary and APL Co. Pte Ltd. (operating as one License Reissuances membership of the agreement. carrier); A.P. Moller-Maersk Sealand; Agreement No.: 011510–018. CMA CGM S.A.; COSCO Container Notice is hereby given that the Title: West African Discussion Lines Ltd.; Hanjin Shipping Co., Ltd.; following Ocean Transportation Agreement. Hapag-Lloyd Container Linie GmbH; Intermediary licenses have been Parties: A.P. Moller-Maersk Sealand, HyundaiMerchant Marine Co., Ltd.; Atlantic Bulk Carriers, HUAL AS, reissued by the Federal Maritime Kawasaki Kisen Kaisha, Ltd.; Mitsui Commission pursuant to section 19 of Mediterranean Shipping Company, P&O O.S.K. Lines, Ltd.; Nippon Yusen the Shipping Act of 1984, as amended Nedlloyd Limited, Safmarine Container Kaisha; Orient Overseas Container Line by the Ocean Shipping Reform Act of Lines, and Zim Israel Navigation Limited; P&O Nedlloyd B.V.; P&O Company. Nedlloyd Limited; Yangming Marine 1998 (46 U.S.C. app. 1718) and the Synopsis: The modification removes Transport Corp. regulations of the Commission Mediterranean Shipping Company as a Synopsis: The proposed amendment pertaining to the licensing of Ocean party to the agreement. would extend the duration of the Transportation Intermediaries, 46 CFR Agreement No.: 011733–008. agreement through August 15, 2004. part 515.

License No. Name/address Date reissued

4085F ...... American Logistics & Purchasing Services, Ltd., 1610 Parkview Avenue, Seaford, NY 11783 ...... April 20, 2003. 1803NF ...... Blue Sky Blue Sea, Inc. dba America Export Lines, dba International Shipping Company 12919 S. March 29, 2003. Figueroa Street, Los Angeles, CA 90061. 13754N ...... L.A.S. Incorporated, 8 Hook Road, Bayonne, NJ 07002 ...... May 11, 2003. 4273NF ...... Primar International, Inc., 15402 Vantage Parkway East, Suite 314, Houston, TX 77032 ...... May 7, 2003. 6098N ...... Sunshine Express Line, Inc., 3250 N.W. North River Drive, Miami, FL 33142 ...... May 11, 2003. 3443F ...... Tradewinds Shipping Corp., 420 Sackett Point Road, Unit 4–B, New Haven, CT 06473–3171 ...... April 20, 2003. 16228N ...... Air & Sea Pak Co. dba Corrigan Air & Sea Cargo Systems, 6170 Middlebelt Road, Romulus, MI April 28, 2003. 48174. 18051N ...... Dominicana Air & Ocean Freight Corp., 1332 NW 36th Street, Jamaica, NJ 33142 ...... May 22, 2003. 3307F ...... American Freight International, Inc., 8169 NW 7th Street, Miami, FL 33166 ...... May 16, 2003.

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Sandra L. Kusumoto, Operating Common Carrier and Ocean set forth in paragraph 7 of the Act (12 Director, Bureau of Consumer Complaints Freight Forwarder—Ocean U.S.C. 1817(j)(7)). and Licensing. Transportation Intermediary pursuant to The notices are available for [FR Doc. 03–15388 Filed 6–17–03; 8:45 am] section 19 of the Shipping Act of 1984 immediate inspection at the Federal BILLING CODE 6730–01–P as amended (46 U.S.C. app. 1718 and 46 Reserve Bank indicated. The notices CFR part 515). also will be available for inspection at Persons knowing of any reason why the office of the Board of Governors. FEDERAL MARITIME COMMISSION the following applicants should not Interested persons may express their receive a license are requested to views in writing to the Reserve Bank Ocean Transportation Intermediary contact the Office of Transportation indicated for that notice or to the offices License Revocations Intermediaries, Federal Maritime of the Board of Governors. Comments must be received not later than July 2, The Federal Maritime Commission Commission, Washington, DC 20573. 2003. hereby gives notice that the following Non-Vessel Operating Common Carrier A. Federal Reserve Bank of Dallas Ocean Transportation Intermediary Ocean Transportation Intermediary (W. Arthur Tribble, Vice President) 2200 licenses have been revoked pursuant to Applicants North Pearl Street, Dallas, Texas 75201- section 19 of the Shipping Act of 1984 2272: (46 U.S.C. app. 1718) and the Speedtrans International, Inc., Suite 1001 Federal Tower Condominium, 1. James Fowler Justiss, III, Jena, regulations of the Commission Louisiana; to acquire voting shares of pertaining to the licensing of Ocean Dasmarinas Street, Binondo, Manila, Officers: Edith P. Vaporoso, Exec. JBI Financial Corporation, Jena, Transportation Intermediaries, effective Louisiana, and thereby indirectly on the corresponding date shown below: Vice President (Qualifying Individual), Susano D. Gemora, Jr., acquire voting shares of Bank of Jena, License Number: 3683F. President. Jena, Louisiana. Name: Martin Strauss Air Freight Pacific-Net Logistics ATL, Inc., 6020 Board of Governors of the Federal Reserve Corp. Dawson Blvd., #F, Norcross, GA System, June 12, 2003. Address: P.O. Box 300666, JFK 30093, Officers: David Hume Shafer, Robert deV. Frierson, International Airport, Jamaica, NY CEO (Qualifying Individual), Michael Deputy Secretary of the Board. 11434. Tsang, CFO. Date Revoked: May 27, 2003. [FR Doc. 03–15316 Filed 6–17–03; 8:45 am] Marenas Shipping, L.L.C., 8074 NW., 66 BILLING CODE 6210–01–S Reason: Surrendered license Street, Miami, FL 33166, Officers: voluntarily. Freddy J. Zelaya, Exec. Manager License Number: 13475N. (Qualifying Individual), Jorge Arenas, FEDERAL RESERVE SYSTEM Name: Triple Alliance Company, Inc. President. Address: 177–25 Rockaway Blvd., Formations of, Acquisitions by, and Suite 204, Jamaica, NY 11434. Non-Vessel Operating Common Carrier Mergers of Bank Holding Companies Date Revoked: May 29, 2003. and Ocean Freight Forwarder Reason: Surrendered license Transportation Intermediary The companies listed in this notice voluntarily. Applicants have applied to the Board for approval, pursuant to the Bank Holding Company CAF Worldwide Inc., 154–09 146th License Number: 16483N. Act of 1956 (12 U.S.C. 1841 et seq.) Avenue, Jamaica, NY 11434, Officers: Name: UniGlobal Logistics, Inc. (BHC Act), Regulation Y (12 CFR Part Joseph F. Barry, Vice President Address: 39 Old Ridgebury Road, 225), and all other applicable statutes (Qualifying Individual), Joseph F. Danbury, CT 07817. and regulations to become a bank Barry, III, President. Date Revoked: June 9, 2003. holding company and/or to acquire the M/S Galaxy Multimodal Systems Pvt. Reason: Surrendered license assets or the ownership of, control of, or Ltd., 7, Kumtha Street, Ballard Estate, voluntarily. the power to vote shares of a bank or Mumbai-400 038, India, Officer: Capt. License Number: 4378NF. bank holding company and all of the P. P. Singh, Managing Director Name: World 2000 Services, Inc. banks and nonbanking companies (Qualifying Individual). Address: 8233 NW., 66th Street, owned by the bank holding company, Miami, FL 33166. Dated: June 13, 2003. including the companies listed below. Date Revoked: May 21, 2003. Bryant L. VanBrakle, The applications listed below, as well Reason: Surrendered license Secretary. as other related filings required by the voluntarily. [FR Doc. 03–15387 Filed 6–17–03; 8:45 am] Board, are available for immediate BILLING CODE 6730–01–P inspection at the Federal Reserve Bank Sandra L. Kusumoto, indicated. The application also will be Director, Bureau of Consumer Complaints, available for inspection at the offices of and Licensing. the Board of Governors. Interested [FR Doc. 03–15389 Filed 6–17–03; 8:45 am] FEDERAL RESERVE SYSTEM persons may express their views in BILLING CODE 6730–01–P Change in Bank Control Notices; writing on the standards enumerated in Acquisition of Shares of Bank or Bank the BHC Act (12 U.S.C. 1842(c)). If the Holding Companies proposal also involves the acquisition of FEDERAL MARITIME COMMISSION a nonbanking company, the review also Ocean Transportation Intermediary The notificants listed below have includes whether the acquisition of the License Applicants applied under the Change in Bank nonbanking company complies with the Control Act (12 U.S.C. 1817(j)) and standards in section 4 of the BHC Act Notice is hereby given that the § 225.41 of the Board’s Regulation Y (12 (12 U.S.C. 1843). Unless otherwise following applicants have filed with the CFR 225.41) to acquire a bank or bank noted, nonbanking activities will be Federal Maritime Commission an holding company. The factors that are conducted throughout the United States. application for license as a Non-Vessel considered in acting on the notices are Additional information on all bank

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holding companies may be obtained other company, in a nonbanking activity FOR FURTHER INFORMATION CONTACT: from the National Information Center that is listed in § 225.28 of Regulation Y Michelle A. Smith, Assistant to the website at www.ffiec.gov/nic/. (12 CFR 225.28) or that the Board has Board; 202–452–2955. Unless otherwise noted, comments determined by Order to be closely SUPPLEMENTARY INFORMATION: You may regarding each of these applications related to banking and permissible for call 202–452–3206 beginning at must be received at the Reserve Bank bank holding companies. Unless approximately 5 p.m. two business days indicated or the offices of the Board of otherwise noted, these activities will be before the meeting for a recorded Governors not later than July 12, 2003. conducted throughout the United States. announcement of bank and bank A. Federal Reserve Bank of Chicago Each notice is available for inspection holding company applications (Phillip Jackson, Applications Officer) at the Federal Reserve Bank indicated. scheduled for the meeting; or you may 230 South LaSalle Street, Chicago, The notice also will be available for contact the Board’s Web site at http:// Illinois 60690-1414: inspection at the offices of the Board of www.federalreserve.gov for an electronic 1. Kankakee Bancorp, Inc., Kankakee, Governors. Interested persons may announcement that not only lists Illinois; to become a bank holding express their views in writing on the applications, but also indicates company by acquiring 100 percent of question whether the proposal complies procedural and other information about the voting shares of State Bank of with the standards of section 4 of the the meeting. Aviston, Aviston, Illinois. BHC Act. Additional information on all In connection with this application, Dated: June 13, 2003. bank holding companies may be Applicant also has applied to retain Robert deV. Frierson, obtained from the National Information control of KFS Bank, F.S.B., Kankakee, Deputy Secretary of the Board. Center website at www.ffiec.gov/nic/. Illinois, and thereby engage in operating [FR Doc. 03–15420 Filed 6–13–03; 4:17 pm] Unless otherwise noted, comments a savings association, pursuant to BILLING CODE 6210–01–P section 225.28(b)(4) of Regulation Y. regarding the applications must be B. Federal Reserve Bank of Kansas received at the Reserve Bank indicated City (James Hunter, Assistant Vice or the offices of the Board of Governors not later than July 2, 2003. FEDERAL RETIREMENT THRIFT President) 925 Grand Avenue, Kansas INVESTMENT BOARD City, Missouri 64198-0001: A. Federal Reserve Bank of 1. Platte County Bancshares, Inc., Minneapolis (Richard M. Todd, Vice Sunshine Act Meeting Platte City, Missouri; to acquire an President and Community Affairs additional 6.2 percent, for a total of 18.7 Officer) 90 Hennepin Avenue, TIME AND DATE: 9 a.m. (EDT), June 20, percent, of the voting shares of Minneapolis, Minnesota 55480-0291: 2003. MidAmerican Bancshares, Inc., 1. Franklin Bancorp, Inc., DBA PLACE: 4th Floor, Conference Room, Harrisonville, Missouri, and thereby Sunrise Community Banks, St. Paul, 1250 H Street, NW., Washington, DC. indirectly acquire voting shares of Allen Minnesota; to engage de novo in STATUS: The meeting will be closed to Bank and Trust Company, Harrisonville, purchasing participations in loans the public. Missouri. originated by its subsidiary banks, MATTERS TO BE CONSIDERED: 2. Peoples Bancshares, Inc., Kansas Discussion pursuant to section 225.28(b)(1) of of litigation matters. City, Missouri; to acquire an additional Regulation Y. FOR FURTHER INFORMATION CONTACT: 22.87 percent, for a total of 68.7 percent, Board of Governors of the Federal Reserve of the voting shares of MidAmerican Thomas J. Trabucco, Director, Office of System, June 12, 2003. External Affairs, (202) 942–1640. Bancshares, Inc., Harrisonville, Robert deV. Frierson, Missouri, and thereby indirectly acquire Dated: June 16, 2003. Deputy Secretary of the Board. voting shares of Allen Bank and Trust Elizabeth S. Woodruff, [FR Doc. 03–15315 Filed 6–17–03; 8:45 am] Company, Harrisonville, Missouri. Secretary to the Board, Federal Retirement BILLING CODE 6210–01–S Board of Governors of the Federal Reserve Thrift Investment Board. System, June 12, 2003. [FR Doc. 03–15584 Filed 6–16–03; 4:00 pm] Robert deV. Frierson, FEDERAL RESERVE SYSTEM BILLING CODE 6760–01–M Deputy Secretary of the Board. [FR Doc. 03–15317 Filed 6–17–03; 8:45 am] Government in the Sunshine Meeting BILLING CODE 6210–01–S Notice FEDERAL TRADE COMMISSION

AGENCY HOLDING THE MEETING: Board of Granting of Request for Early FEDERAL RESERVE SYSTEM Governors of the Federal Reserve Termination of the Waiting Period System. Under the Premerger Notification Notice of Proposals to Engage in Rules TIME AND DATE: 12 p.m., Monday, June Permissible Nonbanking Activities or 23, 2003. to Acquire Companies that are Section 7A of the Clayton Act, 15 Engaged in Permissible Nonbanking PLACE: Marriner S. Eccles Federal U.S.C. 18a, as added by Title II of the Activities Reserve Board Building, 20th and C Hart-Scott-Rodino Antitrust Streets, NW., Washington, DC 20551. Improvements Act of 1976, requires The companies listed in this notice persons contemplating certain mergers STATUS: Closed. have given notice under section 4 of the or acquisitions to give the Federal Trade Bank Holding Company Act (12 U.S.C. MATTERS TO BE CONSIDERED: 1. Personnel Commission and the Assistant Attorney 1843) (BHC Act) and Regulation Y (12 actions (appointments, promotions, General advance notice and to wait CFR Part 225) to engage de novo, or to assignments, reassignments, and salary designated periods before acquire or control voting securities or actions) involving individual Federal consummation of such plans. Section assets of a company, including the Reserve System employees. 7A(b)(2) of the Act permits the agencies, companies listed below, that engages 2. Any items carried forward from a in individual cases, to terminate this either directly or through a subsidiary or previously announced meeting. waiting period prior to its expiration

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and requires that notice of this action be premerger notification rules. The grants Department of Justice. Neither agency published in the Federal Register. were made by the Federal Trade intends to take any action with respect The following transactions were Commission and the Assistant Attorney to these proposed acquisitions during granted early termination of the waiting General for the Antitrust Division of the the applicable waiting period. period provided by law and the

TRANSACTION GRANTED EARLY TERMINATION

ET ET Date Trans No. Req Party Name Status

12–May–03 20030530 G Networks Associates, Inc...... G IntruVert Networks Inc...... G IntruVert Networks Inc. 20030589 G PRIMEDIA Inc...... G PRIMEDIANet Inc...... G Cover Concepts Marketing Services, LLC ...... G PRIMEDIA California Digital Inc...... G PRIMEDIA Magazine Finance, Inc...... G PRIMEDIA Magazines Inc...... G PRIMEDIA Speciality Group Inc. 20030591 G CVC European Equity Partners III L.P...... G E.ON AG...... G Viterra Energy Services AG. 20030592 G A. Jerrold Perenchio...... G Family Stations, Inc...... G Family Stations, Inc. 20030600 G Laird Norton Company LLC...... G DLC Holdings, Inc...... G Dixieline Lumber Company...... G Dixieline Builders Fund Control, Inc. 20030603 G Oxford Industries, Inc...... G Viewpoint International, Inc...... G Viewpoint International, Inc. 14–May–03 20030483 G CRH plc...... G S.E. Johnson Companies Inc...... G S.E. Johnson Companies Inc. 20030485 G Carlyle Partners III, L.P...... G TA Acquisition Holdings, Inc...... G The Aerostructures Corporation. 19–May–03 20030588 G Sumner M. Redstone...... G AOL Time Warner Inc...... G Comedy Partners. 20030596 G Automatic Data Processing, Inc...... G Deutsche Bank AG...... G Deutsche Investment Management Americas Inc...... G Scudder Trust Company...... G Scudder Investments Service Company...... G Scudder Distributors, Inc...... G Deutsche Realty Holdings (II), LLC. 20030604 G Teva Pharmaceutical Industries Limited...... G GlaxoSmithKline plc...... G Glaxo Group Limited. 20030607 G David W. and Freda Barrick...... G John D. Gaughan...... G Exber, Inc...... G Union Plaza Hotel and Casino, Inc...... G Union Plaza Operating Company, Inc...... G Gaughan South Corp. 20030609 G SmartMail, LLC...... G Roy R. Ferber...... G Drop Ship Express, Inc. 20030610 G General Motors Corporation...... G Lend Lease Corporation Limited...... G CapMark Services, L.P...... G Lend Lease Asset Management, L.P...... G Lend Lease Equities S.A. de C.V...... G Lend Lease Japan Inc...... G Lend Lease Real Estate Investments, Inc...... G Lend Lease (US) Inc...... G Pearl Mortgage, Inc. 20030611 G Churchill Equity and ESOP Capital Partners II, L.P...... G Code, Hennessy & Simmons III, L.P...... G CBSA Holdings, L.L.C. 20030617 G Berkshire Hathaway Inc.

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TRANSACTION GRANTED EARLY TERMINATION—Continued

ET ET Date Trans No. Req Party Name Status

...... G Wal-Mart Stores, Inc...... G McLane Company Inc. 21–May–03 20030621 G Jupiter Partners II L.P...... G Gary Damkoehler...... G JSA Healthcare Corporation.

FOR FURTHER INFORMATION CONTACT: FEDERAL TRADE COMMISSION 7A(b)(2) of the Act permits the agencies, Sandra M. Peay, Contact Representative, in individual cases, to terminate this or Renee Hallman, Legal Technician, Granting of Request for Early waiting period prior to its expiration Federal Trade Commission, Premerger Termination of the Waiting Period and requires that notice of this action be Notification Office, Bureau of Under the Premerger Notification published in the Federal Register. Rules Competition, Room H–303, Washington, The following transactions were DC 20580, (202) 326–3100. Section 7A of the Clayton Act, 15 granted early termination of the waiting By Direction of the Commission. U.S.C. 18a, as added by Title II of the period provided by law and the Hart-Scott-Rodino Antitrust premerger notification rules. The grants Donald S. Clark, Improvements Act of 1976, requires were made by the Federal Trade Secretary. person contemplating certain mergers or Commission and the Assistant Attorney [FR Doc. 03–15365 Filed 6–17–03; 8:45 am] acquisitions to give the Federal Trade General for the Antitrust Division of the BILLING CODE 6750–01–M Commission and the Assistant Attorney Department of Justice. Neither agency General advance notice and to wait intends to take any action with respect designated periods before to these proposed acquisitions during consummation of such plans. Section the applicable waiting period.

TRANSACTION GRANTED EARLY TERMINATION

ET ET Date Trans No. Req Party Name Status

27–MAY–03 20030602 G Biovail Corporation ...... G Wyeth ...... G American Cyanamid Company ...... G Wyeth Pharmaceuticals Inc. 20030613 G Tekelec ...... G Santera Systems Inc...... G Santera Systems Inc. 20030615 G Delta Electronics (Thailand) Public Company Limited ...... G Ascom Holding AG ...... G Ascom India Prive Ltd...... G Ascom Rompower, Inc...... G Ascom Energy Systems GmbH ...... G Ascom Energy Systems (Guangzhou) Ltd...... G Ascom UK Limited ...... G Ascom Energy Systems AG ...... G Ascom Spain SA ...... G scom Praha spol. s.r.o. 20030622 G Johnson & Johnson ...... G Helmut D. Link ...... G Link Spine Group, Inc...... G Link Holding Company, Inc. 20030632 G Swift Transportation Co., Inc...... G Wal-Mart Stores, Inc...... G Merit Distribution Services, Inc. 20030639 G Bank One Corporation ...... G Quintiles Transnational Corp...... G Quintiles Transnational Corp. 20030640 G Barry Diller ...... G LendingTree, Inc...... G LendingTree, Inc. 28–MAY–03 20030627 G Fenway Partners Capital Fund II, L.P...... G Lincolnshire Equity Fund II, L.P...... G Riddell Sports Group, Inc. 20030628 G Carlyle Partners III, L.P...... G The UIS Industries, Inc. Voting Trust...... G Pioneer, Inc...... G Neapco Inc...... G Wells Manufacturing Corporation.

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TRANSACTION GRANTED EARLY TERMINATION—Continued

ET ET Date Trans No. Req Party Name Status

...... G Champion Laboratories, Inc...... G Mid-South Mfg., Inc...... G Airtex Products, LLC...... G Automotive Accessory Co. Ltd...... G Talleres Mecanicos Montserrat, S.A. de C.V...... G Brummer Mexicana en Puebla, S.A. de C.V...... G Brummer Seal de Mexico, S.A. de C.V...... G Wells Manufacturing Canada Limited...... G Airtex Products S.A...... G UIS Industries, Ltd. 20030631 G Petroliam Nasional Berhad...... G Neptune Orient Lines Limited...... G American Eagle Tankers Inc. Limited. 20030634 G Hewitt Holdings LLC...... G Michael D. Blair...... G Cybord Worldwide, Inc. 20030637 G SKM Equity Fund III, L.P...... G Murray’s Inc...... G Murray’s Inc. 20030638 G Green Equity Investors III, L.P...... G Werner Holding Co. (PA), Inc...... G Werner Holding Co. (PA), Inc. 20030643 G Odyssey Investment Partners Fund., L.P...... G Scott K. Lemay...... G United Site Services, Inc. 29–MAY–03 20030295 G Southern Union Company...... G CMS Energy Corporation...... G Panhandle Eastern Pipeline Company. 20030626 G McCormick & Company, Inc...... G Zatarain’s Brands, Inc...... G Zatarain’s Brands, Inc. 20030641 G Olympus Growth Fund III, L.P...... G Mettis Group Limited...... G Mettis (UK) Limited. 20030642 G Brockway Moran & Partners Fund II, L.P...... G KKR–FS Associates II LLC...... G WS Acquisition Corp. 20030645 G Health Management Associates, Inc...... G Sisters of Providence, Mother Joseph Providence...... G Providence Health System—Washington...... G Providence Home Care and Hospice...... G Providence Toppenish Hospital...... G John Gabriel Ryan Association...... G Providence Yakima Medical Center. 02–JUN–03 20030612 G Probitas Pharma, S.A...... G Mitsubishi Chemical Corporation...... G Alpha Therapeutic Corporation. 20030649 G Palomino Fund Ltd...... G Conseco, Inc...... G Conseco, Inc. 20030655 G Comcast Corporation...... G George Lane...... G Advanced TeleMedia, LLC 20030657 G Ripplewood Partners II, L.P...... G Lillian Vernon Corporation...... G Lillian Vernon Corporation. 20030658 G Citadel Broadcasting Corporation...... G Wicks Communications & Media Partners, L.P...... G Wilks Broadcasting LLC. 20030659 G Tellabs, Inc...... G Vivace Networks, Inc...... G Vivace Networks, Inc. 04–JUN–03 20030644 G Yorktown Energy Partners, IV, L.P...... G Duke Energy Corporation...... G Duke Energy Field Services, L.P...... G AIM Pipeline, LLC...... G Duke Energy Intrastate Pipeline, LLC...... G Duke Energy Field Services Marketing, LLC. 20030654 G Career Education Corporation...... G Whitman Education Group, Inc.

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TRANSACTION GRANTED EARLY TERMINATION—Continued

ET ET Date Trans No. Req Party Name Status

...... G Whitman Education Group, Inc. 20030656 G Nautic Partners V, L.P...... G Barry L. Downing...... G Corporate Lodging Consultants, Inc...... G Crew Transport Services, Inc...... G Crew Transport Specialists, Inc. 05–JUN–03 20030614 G ScanSoft, Inc...... G SpeechWorks International, Inc...... G SpeechWorks International, Inc.

FOR FURTHER INFORMATION CONTACT: SUPPLEMENTARY INFORMATION: Pursuant Analysis of Agreement Containing Sandra M. Peay, Contact Representative, to section 6(f) of the Federal Trade Consent Order To Aid Public Comment or Renee Hallman, Legal Technician, Commission Act, 38 Stat. 721, 15 U.S.C. The Federal Trade Commission Federal Trade Commission, Premerger 46(f), and Section 2.34 of the (‘‘Commission’’) has accepted, subject to Notification Office, Bureau of Commission’s Rules of Practice, 16 CFR final approval, an agreement containing Competition, Room H–303, Washington, 2.34, notice is hereby given that the a proposed consent order with DC 20580, (202) 326–3100. above-captioned consent agreement Anesthesia Service Medical Group, Inc. By Direction of the Commission. containing a consent order to cease and (‘‘ASMG’’ or ‘‘Respondent’’). The Donald S. Clark, desist, having been filed with and agreement settles charges that Secretary. accepted, subject to final approval, by Respondent violated section 5 of the [FR Doc. 03–15368 Filed 6–17–03; 8:45 am] the Commission, has been placed on the Federal Trade Commission Act, 15 BILLING CODE 6750–01–M public record for a period of thirty (30) U.S.C. 45, by facilitating and days. The following Analysis to Aid implementing agreements with Public Comment describes the terms of Grossmont Anesthesia Services Medical FEDERAL TRADE COMMISSION the consent agreement, and the Group, Inc. (‘‘GAS’’) on fees, quantity of allegations in the complaint. An anesthesia services provided, and other [File No. 021 0006] electronic copy of the full text of the competitively significant terms. The consent agreement package can be proposed consent order has been placed Anesthesia Service Medical Group, on the public record for 30 days to Inc.; Analysis To Aid Public Comment obtained from the FTC Home Page (for May 30, 2003), on the World Wide Web, receive comments from interested AGENCY: Federal Trade Commission. at ‘‘http://www.ftc.gov/os/2003/05/ persons. Comments received during this period will become part of the public ACTION: Proposed consent agreement. index.htm.’’ A paper copy can be obtained from the FTC Public Reference record. After 30 days, the Commission will review the agreement and the SUMMARY: The consent agreement in this Room, Room 130–H, 600 Pennsylvania comments received, and will decide matter settles alleged violations of Avenue, NW., Washington, DC 20580, whether it should withdraw from the Federal law prohibiting unfair or either in person or by calling (202) 326– deceptive acts or practices or unfair agreement or make the proposed order 2222. methods of competition. The attached final. Analysis to Aid Public Comment Public comments are invited, and may The purpose of this analysis is to describes both the allegations in the be filed with the Commission in either facilitate public comment on the draft complaint that accompanies the paper or electronic form. Comments proposed order. The analysis is not consent agreement and the terms of the filed in paper form should be directed intended to constitute an official consent order—embodied in the consent to: FTC/Office of the Secretary, Room interpretation of the agreement and agreement—that would settle these 159–H, 600 Pennsylvania Avenue, NW., proposed order, or to modify their terms allegations. Washington, DC 20580. If a comment in any way. Further, the proposed consent order has been entered into for DATES: Comments must be received on contains nonpublic information, it must settlement purposes only and does not or before June 30, 2003. be filed in paper form, and the first page of the document must be clearly labeled constitute an admission by any ADDRESSES: Comments filed in paper ‘‘confidential.’’ Comments that do not Respondent that said Respondent form should be directed to: FTC/Office violated the law or that the facts alleged of the Secretary, Room 159–H, 600 contain any nonpublic information may instead be filed in electronic form (in in the complaint (other than Pennsylvania Avenue, NW., jurisdictional facts) are true. Washington, DC 20580. Comments filed ASCII format, WordPerfect, or Microsoft in electronic form should be directed to: Word) as part of or as an attachment to The Complaint Allegations [email protected], as email messages directed to the following ASMG and GAS are competing prescribed in the Supplementary email box: [email protected]. anesthesiology groups that provide Information section. Such comments will be considered by anesthesia services for a fee to patients FOR FURTHER INFORMATION CONTACT: John the Commission and will be available in San Diego County, California. ASMG Wiegand or Kerry O’Brien, FTC Western for inspection and copying at its employs approximately 180 Regional Office, 901 Market St., Suite principal office in accordance with anesthesiologists. GAS is composed of 570, San Francisco, CA 94103, (415) Section 4.9(b)(6)(ii) of the Commission’s approximately 10 anesthesiologists. 848–5100. Rules of Practice, 16 CFR 4.9(b)(6)(ii)). ASMG and GAS anesthesiologists are

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members of the medical staff of demand from the hospital for taking improve quality by managing the Grossmont Hospital in La Mesa, a obstetric call. ASMG and GAS also provision of services. Second, any municipality in central San Diego discussed reducing their hours of agreement concerning reimbursement or County, California. ASMG and GAS availability for taking call to increase other terms or conditions of dealing anesthesiologists make up their negotiating power with the must be reasonably necessary to obtain approximately 75 percent of the hospital. Furthermore, they agreed to significant efficiencies through the joint anesthesiologists with active medical maintain a solid front against the arrangement. To be a ‘‘qualified staff privileges at Grossmont Hospital hospital to prevent the hospital from (1) clinically-integrated joint arrangement,’’ and work on approximately 70 percent negotiating separately with each group an arrangement must satisfy two of the cases that require anesthesia to reduce the amount of the stipend or conditions. First, all participants must services at the hospital. (2) seeking services solely from one join in active and ongoing programs to Anesthesiologists provide anesthesia group to the exclusion of the other. evaluate and modify their clinical services to patients primarily at general ASMG and GAS ceased this collusive practice patterns, creating a high degree acute care hospitals and outpatient activity only after the Commission of interdependence and cooperation surgery centers. Those services include contacted them about this conduct. among providers to control costs and evaluating a patient before surgery, While the Commission’s investigation ensure the quality of services provided. consulting with the surgical team, prevented any anticompetitive effects Second, any agreement concerning providing pain control and support-of- from occurring, this conduct is a naked reimbursement or other terms or life functions during surgery, restraint, which constitutes an unfair conditions of dealing must be supervising care after surgery in the method of competition in violation of reasonably necessary to obtain recovery unit, and medically section 5 of the FTC Act. significant efficiencies through the joint discharging the patient from the The Proposed Consent Order arrangement. Both definitions reflect the recovery unit. In addition to working on analyses contained in the 1996 FTC/DOJ scheduled surgical procedures, The proposed consent order is Statements of Antitrust Enforcement anesthesiologists work on unscheduled designed to prevent recurrence of the Policy in Health Care. obstetric and emergency cases at general illegal concerted actions alleged in the Paragraphs III through V of the acute care hospitals. An anesthesiologist complaint while allowing Respondent proposed order are reporting and who remains available to work on to engage in legitimate joint conduct. compliance provisions. Paragraph VI is Paragraph II.A prohibits Respondent unscheduled cases is said to be ‘‘taking a provision ‘‘sunsetting’’ the order after from entering into or facilitating call.’’ 20 years. Anesthesiologists in San Diego agreements between or among medical County are reimbursed for their services practices: (1) To negotiate, to fix, or to By direction of the Commission. from several sources. Health insurance establish any fee, stipend, or any other Donald S. Clark, companies and other third-party payors term of reimbursement for the provision Secretary. typically reimburse anesthesiologists for of anesthesia services; (2) to deal, to [FR Doc. 03–15366 Filed 6–17–03; 8:45 am] refuse to deal, or to threaten to refuse to services rendered to their subscribers BILLING CODE 6750–01–P during scheduled and unscheduled deal with any payor of anesthesia medical procedures and obstetrical services; or (3) to reduce, or to threaten cases through contracts that establish to reduce, the quantity of anesthesia FEDERAL TRADE COMMISSION fees and other competitively significant services provided to any purchaser of terms. In addition, some hospitals pay anesthesia services. A ‘‘medical [File No. 021 0006] anesthesiologists ‘‘stipends’’ for taking practice’’ is defined as a bona fide, call and/or for rendering services to integrated business entity in which Grossmont Anesthesia Services uninsured patients. Some hospitals pay physicians practice medicine together as Medical Group, Inc.; Analysis To Aid anesthesiologists stipends through partners, shareholders, owners, Public Comment contracts that establish a stipend members, or employees, or in which AGENCY: Federal Trade Commission. amount and other competitively only one physician practices medicine. ACTION: Proposed consent agreement. significant terms. Paragraph II.B prohibits Respondent Absent agreements among competing from attempting to engage in any action SUMMARY: The consent agreement in this anesthesiologists, competing prohibited by Paragraph II.A. Paragraph matter settles alleged violations of anesthesiologists or anesthesiology II.C prohibits Respondent from Federal law prohibiting unfair or groups decide independently whether to encouraging, pressuring, or attempting deceptive acts or practices or unfair seek a stipend from a hospital and the to induce any person to engage in any methods of competition. The attached amount of the stipend. They also decide action that would be prohibited by Analysis to Aid Public Comment independently whether they will Paragraphs II.A and II.B. describes both the allegations in the terminate or restrict the services they Paragraph II contains a proviso that draft complaint that accompanies the provide to unscheduled or uninsured allows Respondent to engage in conduct consent agreement and the terms of the patients if the hospital refuses to pay that is reasonably necessary to the consent order—embodied in the consent them a stipend or if they are dissatisfied formation or operation of a ‘‘qualified agreement—that would settle these with the stipend. risk-sharing joint arrangement’’ or a allegations. From as early as February 2001 ‘‘qualified clinically-integrated joint through March 2002, ASMG and GAS arrangement.’’ To be a ‘‘qualified risk- DATES: Comments must be received on discussed between themselves a joint sharing joint arrangement,’’ an or before June 30, 2003. strategy to secure stipends from arrangement must satisfy two ADDRESSES: Comments filed in paper Grossmont Hospital for taking obstetric conditions. First, all participating form should be directed to: FTC/Office call and for rendering services to providers must share substantial of the Secretary, Room 159–H, 600 uninsured emergency room patients. financial risk through the arrangement Pennsylvania Avenue, NW., Eventually, ASMG and GAS agreed on and thereby create incentives for the Washington, DC 20580. Comments filed the stipend amount both groups would participants jointly to control costs and in electronic form should be directed to:

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[email protected], as Respondent violated section 5 of the acute care hospitals. An anesthesiologist prescribed in the SUPPLEMENTARY Federal Trade Commission Act, 15 who remains available to work on INFORMATION section. U.S.C. 45, by facilitating and unscheduled cases is said to be ‘‘taking FOR FURTHER INFORMATION CONTACT: John implementing agreements with call.’’ Wiegand or Kerry O’Brien, FTC Western Anesthesia Service Medical Group, Inc. Anesthesiologists in San Diego Regional Office, 901 Market St., Suite (‘‘ASMG’’) on fees, quantity of County are reimbursed for their services 570, San Francisco, CA 94103, (415) anesthesia services provided, and other from several sources. Health insurance 848–5100. competitively significant terms. The companies and other third-party payors proposed consent order has been placed typically reimburse anesthesiologists for SUPPLEMENTARY INFORMATION: Pursuant services rendered to their subscribers to section 6(f) of the Federal Trade on the public record for 30 days to during scheduled and unscheduled Commission Act, 38 Stat. 721, 15 U.S.C. receive comments from interested persons. Comments received during this medical procedures and obstetrical 46(f), and Section 2.34 of the period will become part of the public cases through contracts that establish Commission’s Rules of Practice, 16 CFR record. After 30 days, the Commission fees and other competitively significant 2.34, notice is hereby given that the will review the agreement and the terms. In addition, some hospitals pay above-captioned consent agreement comments received, and will decide anesthesiologists ‘‘stipends’’ for taking containing a consent order to cease and whether it should withdraw from the call and/or for rendering services to desist, having been filed with and agreement or make the proposed order uninsured patients. Some hospitals pay accepted, subject to final approval, by final. anesthesiologists stipends through the Commission, has been placed on the The purpose of this analysis is to contracts that establish a stipend public record for a period of thirty (30) facilitate public comment on the amount and other competitively days. The following Analysis to Aid proposed order. The analysis is not significant terms. Public Comment describes the terms of intended to constitute an official Absent agreements among competing the consent agreement, and the interpretation of the agreement and anesthesiologists, competing allegations in the complaint. An proposed order, or to modify their terms anesthesiologists or anesthesiology electronic copy of the full text of the in any way. Further, the proposed groups decide independently whether to consent agreement package can be consent order has been entered into for seek a stipend from a hospital and the obtained from the FTC Home Page (for settlement purposes only and does not amount of the stipend. They also decide May 30, 2003), on the World Wide Web, constitute an admission by any independently whether they will at ‘‘http://www.ftc.gov/os/2003/05/ Respondent that said Respondent terminate or restrict the services they index.htm.’’ A paper copy can be violated the law or that the facts alleged provide to unscheduled or uninsured obtained from the FTC Public Reference in the complaint (other than patients if the hospital refuses to pay Room, Room 130–H, 600 Pennsylvania jurisdictional facts) are true. them a stipend or if they are dissatisfied Avenue, NW., Washington, D.C. 20580, with the stipend. either in person or by calling (202) 326– The Complaint Allegations From as early as February 2001 2222. GAS and ASMG are competing through March 2002, GAS and ASMG Public comments are invited, and may anesthesiology groups that provide discussed between themselves a joint be filed with the Commission in either anesthesia services for a fee to patients strategy to secure stipends from paper or electronic form. Comments in San Diego County, California. ASMG Grossmont Hospital for taking obstetric filed in paper form should be directed employs approximately 180 call and for rendering services to to: FTC/Office of the Secretary, Room anesthesiologists. GAS is composed of uninsured emergency room patients. 159–H, 600 Pennsylvania Avenue, NW., approximately 10 anesthesiologists. Eventually, GAS and ASMG agreed on Washington, DC 20580. If a comment GAS and ASMG anesthesiologists are the stipend amount both groups would contains nonpublic information, it must members of the medical staff of demand from the hospital for taking be filed in paper form, and the first page Grossmont Hospital in La Mesa, a obstetric call. GAS and ASMG also of the document must be clearly labeled municipality in central San Diego discussed reducing their hours of ‘‘confidential.’’ Comments that do not County, California. GAS and ASMG availability for taking call to increase contain any nonpublic information may anesthesiologists make up their negotiating power with the instead be filed in electronic form (in approximately 75 percent of the hospital. Furthermore, they agreed to ASCII format, WordPerfect, or Microsoft anesthesiologists with active medical maintain a solid front against the Word) as part of or as an attachment to staff privileges at Grossmont Hospital hospital to prevent the hospital from (1) email messages directed to the following and work on approximately 70 percent negotiating separately with each group email box: [email protected]. of the cases that require anesthesia to reduce the amount of the stipend or Such comments will be considered by services at the hospital. (2) seeking services solely from one the Commission and will be available Anesthesiologists provide anesthesia group to the exclusion of the other. for inspection and copying at its services to patients primarily at general ASMG and GAS ceased this collusive principal office in accordance with acute care hospitals and outpatient activity only after the Commission section 4.9(b)(6)(ii) of the Commission’s surgery centers. Those services include contacted them about this conduct. Rules of Practice, 16 CFR 4.9(b)(6)(ii)). evaluating a patient before surgery, While the Commission’s investigation consulting with the surgical team, prevented any anticompetitive effects Analysis of Agreement Containing providing pain control and support-of- Consent Order to Aid Public Comment from occurring, this conduct is a naked life functions during surgery, restraint, which constitutes an unfair The Federal Trade Commission supervising care after surgery in the method of competition in violation of (‘‘Commission’’) has accepted, subject to recovery unit, and medically section 5 of the FTC Act. final approval, an agreement containing discharging the patient from the a proposed consent order with recovery unit. In addition to working on The Proposed Consent Order Grossmont Anesthesia Services Medical scheduled surgical procedures, The proposed consent order is Group, Inc. (‘‘GAS’’ or ‘‘Respondent’’). anesthesiologists work on unscheduled designed to prevent recurrence of the The agreement settles charges that obstetric and emergency cases at general illegal concerted actions alleged in the

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complaint while allowing Respondent Paragraphs III through V of the Administrative questions will be to engage in legitimate joint conduct. proposed order are reporting and accepted and responded to up to ten Paragraph II.A prohibits Respondent compliance provisions. Paragraph VI is working days prior to closing date of from entering into or facilitating a provision ‘‘sunsetting’’ the order after receipt of applications. Technical agreements between or among medical 20 years. questions should be directed to Brenda practices: (1) To negotiate, to fix, or to By direction of the Commission. Benesch, either by telephone (202–260– establish any fee, stipend, or any other Donald S. Clark, 0382), fax (202–690–6562), e-mail term of reimbursement for the provision ([email protected]) or in writing Secretary. of anesthesia services; (2) to deal, to at the following address, Office of the refuse to deal, or to threaten to refuse to [FR Doc. 03–15367 Filed 6–17–03; 8:45 am] Assistant Secretary for Planning and deal with any payor of anesthesia BILLING CODE 6750–01–P Evaluation, Department of Health and services; or (3) to reduce, or to threaten Human Services, 200 Independence to reduce, the quantity of anesthesia Avenue, SW., Room 450G, Hubert H. services provided to any purchaser of DEPARTMENT OF HEALTH AND Humphrey Building, Washington, DC anesthesia services. A ‘‘medical HUMAN SERVICES 20201. If you send your question(s) in practice’’ is defined as a bona fide, writing, please call to confirm receipt. Office of the Secretary, Assistant integrated business entity in which Technical questions will be accepted Secretary for Planning and Evaluation; physicians practice medicine together as and responded to up to ten working Notice of Funding Availability for partners, shareholders, owners, days prior to the closing date of receipt Policy and Research Grants (State members, or employees, or in which of applications. Innovation Grants) only one physician practices medicine. Application Materials: Application Paragraph II.B prohibits Respondent AGENCY: The Office of the Assistant materials are included in this package from attempting to engage in any action Secretary for Planning and Evaluation and are also available from the ASPE prohibited by Paragraph II.A. Paragraph (ASPE), HHS. World Wide Web site: http:// II.C prohibits Respondent from ACTION: Notice of grant competition. aspe.hhs.gov/funding.htm or by calling encouraging, pressuring, or attempting to be determined. to induce any person to engage in any SUMMARY: The Office of the Assistant SUPPLEMENTARY INFORMATION: This action that would be prohibited by Secretary for Planning and Evaluation program announcement consists of five Paragraphs II.A and II.B. announces its intention to conduct a parts: Part I: Background—Legislative Paragraph II contains a proviso that grant competition for ASPE State authority, Background information, allows Respondent to engage in conduct Innovation Demonstration Grants. This Purpose, Technical assistance and that is reasonably necessary to the competition is limited to current process evaluation; Part II: Project and formation or operation of a ‘‘qualified recipients of FY 2002 ASPE State Applicant Eligibility—Eligible risk-sharing joint arrangement’’ or a Innovation Planning Grants. applicants, Available funds, Budget and ‘‘qualified clinically-integrated joint The Catalog of Federal Domestic project period, and Matching arrangement.’’ To be a ‘‘qualified risk- Assistance Number: The CFDA number requirements; Part III: The Review sharing joint arrangement,’’ an is 93.239. Process—Intergovernmental review, arrangement must satisfy two Closing Date: The closing date for Initial screening, and Competitive conditions. First, all participating submitting applications under this review and evaluation criteria; Part IV: providers must share substantial announcement is August 18, 2003. The Application—Application financial risk through the arrangement Please email Brenda Benesch at development, Application submission, and thereby create incentives for the [email protected] by July 8, Disposition of applications, and participants jointly to control costs and 2003 to inform the government of your Components of a complete application; improve quality by managing the intent to submit an application. Please Part V: Questions and Answers. include the proposed title of the project provision of services. Second, any Part I. Background agreement concerning reimbursement or and the name of the agency submitting other terms or conditions of dealing the application. Providing notice of A. Legislative Authority intent to submit is not a requirement for must be reasonably necessary to obtain This announcement is authorized by submitting an application. However, a significant efficiencies through the joint section 1110 of the Social Security Act notice of intent to submit will help the arrangement. To be a ‘‘qualified (42 U.S.C. 1310) and section 310 of the federal government in planning for the clinically-integrated joint arrangement,’’ Public Health Service Act and awards review process. an arrangement must satisfy two will be made from funds appropriated Mailing Address: Applications should conditions. First, all participants must under the Consolidated Appropriations be submitted to be determined. join in active and ongoing programs to Resolution, 2003 (Pub. L. 108–7). evaluate and modify their clinical You will receive email confirmation practice patterns, creating a high degree to notify you that your application was B. Background Information of interdependence and cooperation received within 14 days of the closing In FY 2002 ASPE awarded state among providers to control costs and date. If you do not receive confirmation innovation demonstration grants to five ensure the quality of services provided. within 14 days of the closing date, states and planning grants to ten states Second, any agreement concerning please contact to be determined at the to help them implement or develop reimbursement or other terms or address above. innovative approaches for providing conditions of dealing must be The printed Federal Register notice is health and human services more reasonably necessary to obtain the only official program efficiently. Planning grants were significant efficiencies through the joint announcement. awarded for up to a 17-month project arrangement. Both definitions reflect the FOR FURTHER INFORMATION CONTACT: period. The following planning grants analyses contained in the 1996 FTC/DOJ Administrative questions should be were awarded: Statements of Antitrust Enforcement directed to be determined at the address • Alaska Department of Health and Policy in Health Care. or phone number listed above. Social Sciences— ‘‘Planning for

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Comprehensive Early Childhood Mental determine that the continuation of the that the continuation of the project is Health in Alaska’’; project is consistent with the purposes consistent with the purpose of the • Arizona Department of Health of the announcement. announcement. Services— ‘‘Arizona Diabetic Patient After a grant award is made, any D. Technical Assistance and Process Self-Management Project’’; purchase of computer hardware or Evaluation • Arkansas Department of Human software needs to be requested in Services— ‘‘Improving Transitions from The Lewin Group will provide a writing by the grantee and approved in the Institutions into the Community’’; limited amount of tailored technical writing by the ASPE project officer and • Delaware Health and Social assistance to the states. The the grants officer. Purchases of Services— ‘‘Self-Directed Supports for independent process evaluation begun computer hardware or software for Community Living’’; in the FY2002 phase of the State routine uses will not be considered. See • District of Columbia Department of Innovation Grants initiative will be Part IV, Section II for more information Health— ‘‘DC Youth Violence expanded to document the progress of on review criteria for MIS/Data System Prevention Initiative-’’; the FY2003 grantees. The process • proposals. Iowa Department of Human evaluation will, at a minimum, address No funds may be paid as profit to Services— ‘‘Healthy Marriage/ key research questions: grantees or subgrantees, i.e., any amount Responsible Fatherhood’’; 1. What are the issues and challenges • is excess of allowable direct and Kansas Department of Social and associated with implementing and indirect costs of the recipient (45 CFR Rehabilitation Services— ‘‘Child operating the funded projects? 74.81). Grant monies can be used for 2. What are the expected short and Welfare Wrap Around Service client services to the extent that the cost long-term implications of this Delivery’’; of the services cannot be covered under • intervention for clients, as well as for Maryland Department of Aging— existing programs. ‘‘Changing Interagency Service Delivery agencies involved? Systems to Help Older Public Housing 3. What other innovative ideas/ D. Matching Requirements Residents’’; projects may grow out of each funded • Grantees must provide at least 10 New Hampshire State Department project and the program as a whole? percent of the total approved cost of the We expect that the work undertake of Health and Human Services— project. The total approved cost of the through this evaluation will result in ‘‘Granite State Data Archive’’; and project is the sum of the Federal share • South Carolina Department of important operational lessons and and the non-Federal share. The non- Social Services— ‘‘Keep Them Home: sound information about implementing Federal share may be met by cash or in- An Adult Protective Service Program.’’ innovative approaches. ASPE expects kind contributions, although applicants that this investment will benefit low- are encouraged to meet their match C. Purpose income clients and families, state and requirements through cash ASPE has determined that building on local health and human service contributions. For example, a state with the efforts already underway is the most administrators, others who work with a project with a total budget (both direct efficient use of the Fiscal Year 2003 low-income people, and the general and indirect costs) of $500,000 may state innovative grant funds. Since fiscal public. limitations prevent use from funding all request up to $450,000 in federal funds. ten planning grantees to move into a Part II. Project and Applicant Eligibility Matching requirements cannot be met second-year, transitional planning/ A. Eligible Applicants with funds from other federally-funded programs. demonstration phase, we plan to This grant competition is limited to conduct a limited competition among If a proposed project activity has the FY2002 State Innovation Grant approved funding support from other the planning grantees in order to select recipients (see Part I B). 2–3 that will receive second-year funding sources, the amount, duration, resources. ASPE’s goal in supporting B. Available Funds purpose, and source of the funds should be indicated in materials submitted this phase is to enable some states to Approximately $1 million is expected implement their innovative ideas, as under this announcement. If completion to be available from ASPE funds of the proposed project activity is well as to improve our understanding of appropriated for fiscal year 2003. We the process of successful innovation. contingent upon approval of funding estimate that this level of funding will from other sources, the relationship Planning grantees that receive support between 2–3 grants. additional funding will be expected to between the funds being sought strengthen their activities and begin C. Budget and Project Period elsewhere and from ASPE should be implementation. We anticipate that Awards under this announcement discussed in the budget information lessons learned from the planning and will be made for 12-month budget submitted as a part of the abstract. In implementation process will assist periods. States may propose projects up both cases, the contribution that ASPE program directors and state officials to 36 months in duration. Subject to the funds will make to the project should be across the country in planning and availability of funds, grantees with clearly presented. implementing innovative projects. We projects which last longer then 12 Part III. The Review Process plan to provide additional funding to 2– months may be allowed to submit 3 grantees. Each applicant may request subsequent applications for additional A. Intergovernmental Review funds in the range of $300,000–$500,000 funding, at a lower funding level, for State Single Point of Contact (E.O. No. per year for a maximum of three years. additional budget period(s). Decisions 12372)—DHHS has determined that this Decision on subsequent funding will be on subsequent funding will be made on program is not subject to Executive made on a noncompetitive basis based a noncompetitive basis based on the Order 12372, ‘‘Intergovernmental on the availability of funds, the availability of funds, the adequacy of Review of Federal Programs.’’ adequate progress of the grantee, and grantee progress, and such other similar Applicants are not required to seek such other similar criteria as the criteria as the Department may intergovernmental review of their Department determines. Any requested determine. Any requests for additional applications within the constraints of additional funding will be reviewed to funding also will be reviewed to ensure E.O. 12372.

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B. Initial Screening of the proposed approach, the to which it can be obtained or accessed Each application submitted under this application should identify the key, by the applicant organization, the program announcement will undergo a relevant organizations that will be existence of data exchange agreements pre-review to determine that (1) the involved in project activity and describe with other agencies that are the source application was received by the closing operational relationships that exist or of needed data, and the willingness of will be put into place among the state, the applicant agency to obtain data date and submitted in accordance with local public, private and non-profit needed for the evaluation. Any the instructions in this announcement; agencies, and any other entities. Plans limitations regarding data availability or (2) the applicant is eligible for funding; for cross-agency collaboration should be access should be discussed, including (3) the applicant has included clearly explained. any fees for data. assurances that they and other relevant Applicants should include a Any application for a project participating organizations will be discussion of the proposed approach for involving the use of personally- willing to field test strategies, based on implementing and operating the identifiable information about patients their initial planning phase, and will innovative strategies identifying specific or clients that grantees collect should participate in a process evaluation to steps to be undertaken. The approach describe how the project intends to document the steps taken from planning should include a discussion of the time address the privacy and confidentiality to implementation [this must be frame and action steps necessary before issues presented by the data collection. indicated on the page with the project the implementation/demonstration The description should not include abstract—see part IV, section E, 8(a)]; phase of the project becomes details of collection, consent, security and (4) is within the page limit (see part operational (e.g., staff must be trained and the like. It should describe the IV, section A). Note that applications over the next six months; partnerships organizational and planning approaches exceeding the page limit will not be with local agencies, non-profits, that will ensure that the project reviewed further and will be ineligible employers, etc. must be established, addresses these issues in a thoughtful for funding. etc.). Applicants should provide a way, respectful of the patients’ and C. Competitive Review and Evaluation detailed description of the steps clients’ privacy and dignity, in accord Criteria necessary to transition from a planning with all applicable law, and, if grant to a larger demonstration grant. appropriate, taking particular account of Applications that pass the initial Applicants should also describe how the special privacy issues created by ASPE pre-review screening will be the transition to a demonstration grant systems that integrate or link evaluated and rated by an independent will affect goals and objectives. In administrative data across several review panel on the basis of specific particular, applicants should address programs that serve the same evaluation criteria. The evaluation whether or not goals and objectives population. criteria are designed to assess the identified for the planning phase will (2) Objectives and Need for Assistance: quality of the proposed project and to need to be modified for the transition to (15 points) determine the likelihood of its success. a demonstration phase. The application The evaluation criteria are closely will be judged based on the extent to The applications should describe (1) related and are considered as a whole in which the proposed project issues and challenges which the judging the overall quality of an demonstrates a firm commitment of applicant has considered and dealt with application. Points are awarded only to State, and/or local, and/or private to date in designing and/or applications that are responsive to the funding and/or in-kind contributions implementing strategies for system evaluation criteria as provided in this dedicated to sustainability of the improvements, including an assessment program announcement. project, on the extent to which it is of the current delivery system and the In order to ensure that the interests of innovative, and on its potential for most urgent needs of the project’s target the Federal Government are met, in improving outcomes either in target population or system, and (2) the making the final selections, ASPE may populations or management of state proposed strategy for the transition from consider additional factors, in addition programs. a planning to a demonstration phase to the review criteria identified below. The application should include a brief and ways in which it will significantly These additional factors may include discussion of the location of the enhance innovative services for the such things as the applicants’ readiness proposed project to be implemented. target population. (3) A description of to transition from a planning to an Maps or other graphic aids may be existing resources and programs for the implementation phase; capacity for attached. Applications should include target population, barriers in the current continued and sustainable innovation; appropriate information about the size delivery system, and gaps in service the potential impact of the innovation of the target population in the proposed delivery should also be included. The on the target population; the potential site/area and other data or information applicant should include any for building upon funding activities; the available that relate to the project supporting data or available information extent of partnerships with local activity. gained during the planning phase that entities; and the overall diversity of It may be necessary for agencies to further demonstrates why the program activities within the applicant provide data to Lewin or to HHS. The innovation is needed, and how the pool. types of data possibly requested under planning phase contributed to the Proposed projects will be reviewed this project may include administrative development of innovative ways to using the following evaluation criteria: data, including data on program serve the target populations. attendance, or other participation data. Applications will be judged on the (1) Approach: (40 points) Data may also be collected from relevance of the discussion to the The application will be judged on the program managers and staff and from program objectives set out within this extent to which the proposed individuals participating in the announcement. The application will approaches to project activities are demonstration program to be also be judged on the extent to which adequate and appropriate to meet the implemented. The proposed approach the innovation proposed will help to objectives for projects in this program as should indicate the availabilty of such address the target population’s needs, set out in this announcement. As a part data, the source of the data, the extent build the knowledge base, and have

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applicability to a range of states and (5) Adequacy of Workplan (10 points) certificates, and the like. Forms are localities. Applicants should provide details available from GRANTS OFFICER TO BE DETERMINED or may be obtained (3) Results or Benefits Expected: (15 about how planning projects will be electronically from the ASPE World points) implemented. Applications should delineate tasks for completing the work, Wide Web site: http://aspe.hhs.gov/ The application should describe how indicate staff assignments for each task, funding.htm. Applications that are not the proposed implementation phase will and provide a schedule for completing received in the format described above address the identified needs and each task. Applicants should also and/or exceed the page limit, will not be improve the delivery of services or describe mechanisms that will be put in reviewed. Applicants are requested to activities. The application should place to maintain quality control over be concise. Applicants are encouraged identify specific outcome measures the project. The application will be not to attach or include bound reports or other documents. (goals) to be achieved through judged on the appropriateness and implementation of the innovation. timeliness of the work schedule and B. Application Submission Goals should be tied to discrete, tasks, staff assignments, and quality 1. Mailed applications must be measurable objectives. Examples assurance plan. include: increase in the proportion of postmarked by midnight three days participants entering jobs at higher wage (6) Budget Appropriateness (10 points) prior to the closing date. Otherwise, levels; increased partnerships between they will be classified as late. The application must include a 2. Deadline. The closing date agencies and employers to support narrative description and justification (deadline) for submission of working families; increased access to for proposed budget line items and applications is August 18, 2003. Please health and human services benefits; demonstrate that the project’s costs are email Brenda Benesch at increased integration of programs or adequate, reasonable and necessary for [email protected] by July 8, services targeting clients with multiple the activities or personnel to be 2003 to inform the government of your barriers; increased innovation related to supported. The budget and narrative intent to submit an application. ‘‘consumer-directed’’ approaches to should have a clear relationship to the Providing notice of intent to submit is home and community-based long-term approach. The application will be not a requirement for submitting an care services; more rapid access to judged on the extent to which adequate application. However, a notice of intent program and client date; etc. The staffing and other resources will be to submit will help the Federal application will be judged on the extent provided as required to successfully government in the planning for the to which the proposed program design carry out the tasks and activities review process. USPS mailed or policies can be expected to achieve proposed. (Applicants should refer to applications shall be considered as the stated project goals. the budget information presented in the meeting the announced deadline if they In committing to participate in a Standard Forms 424 and 424A, which are either received on or before the process evaluation, applicants should be can be found at http://aspe.hhs.gov/ deadline date or postmarked by able to report baseline information, funding.htm). midnight three days prior to the closing including the size of the target Part IV. The Application date and received by ASPE in time for population and the expected number of the independent review (within 2 weeks individuals or families to be served by A. Application Development of the deadline): to be determined. the project, as appropriate. Interim and In order to be considered for an award If applicants use a commercial mail final program reports will be required. under this program announcement, an service, they must ensure that a legibly (4) Staff and Position Data (10 Points) application must be submitted on the dated, machine produced postmark of a forms supplied and in the manner commercial mail service is affixed to the The application should include a prescribed by ASPE. Application envelope/package containing the listing of key individuals who will materials including forms and application. To be acceptable as proof of oversee and work on the project, instructions are attached to this timely mailing, a postmark from a specifically identifying the key announcement. Additional copies are commercial mail service must include individuals from the applicant agency available from to be determined. the logo/emblem of the commercial mail who will serve as the primary contacts Applicants should refer to the service company and must reflect the for ASPE and contractor staff, indicating attached application kit for instructions date the package was received by the their positions, areas of responsibility regarding which forms, certifications commercial mail service company from and authority, and the proportion of and assurances are required and for the applicant. Private metered time that will be available for project instructions on completing the forms postmarks shall not be acceptable as activity. and preparing and submitting the proof of timely mailing. (Applicants are Applications will be judged on the application. Each application package cautioned that express/overnight mail extent to which individuals with must include an original and two copies services do not always deliver as appropriate authority, positions, and of the complete application. All pages of agreed.) experience will work on the project and the narrative must be sequentially Applications hand-carried by the adequacy of time allocated for key numbered and unbound. applicants, applicant couriers, or by staff to the project. In addition, the Applications must be received in the other representatives of the applicant application will be judged on the extent following format: shall be considered as meeting the to which there is a commitment to the • 12 point font size announced deadline if they are received project evidenced by the participation of • Single line spacing on or before the deadline date, between senior state and local officials and • 1 inch top, bottom, left, and right the hours of 8 a.m. and 4:30 p.m. EST, managers and on the adequacy of the margins at: to be determined. The address must proposed plans for obtaining advice and • Applications should not exceed 20 appear on the envelope/package direction regarding project work and pages. Page limits apply to items containing the application with the note involvement and assistance to resolve Section IV, D, 8(b–e) only; page limits ‘‘Attention: to be determined’’ issues or problems, as appropriate. do not include standard forms, (Applicants are cautioned that express/

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overnight mail services do not always 8. Project Narrative Statement, and (10) South Carolina Department of deliver as agreed). organized in six sections, addressing the Social Services—‘‘Keep Them Home: Applications transmitted by fax or following topics (b) through (e) are An Adult Protective Service Program’’. through other electronic means will not limited to twenty (20) single-spaced be accepted regardless of date or time of pages: 2. How Much Money Is Available for submission or receipt. (a) Abstract (must include assurance Grants Under This Announcement? 3. Late applications. Applications that of willingness to participate in a process The total that is available under this do not meet the criteria above are evaluation), considered late applications. To be announcement is approximately $1 (b) Goals, Objectives and Usefulness million. ASPE anticipates that determined shall notify each late of the Project, applicant that its application will not be individual awards will be between (c) Methodology and Design, $300,000–$500,000 per year. considered in the current competition. (d) Background of the Personnel and 4. Extension of deadlines. NICHD may Organizational Capabilities, 3. How Many Awards Will Be Made or extend an application deadline when (e) Work plan (timetable), and How Many Applications Will Be circumstances such as acts of God (f) Budget narrative. Approved? (floods, hurricanes, etc.) occur, or when 9. Certification Regarding Drug-Free there are widespread disruptions of the Workplace; ASPE anticipates awarding 2–3 mail service, or in other rare cases. 10. Certification Regarding grants. Determinations to extend or waive Debarment, Suspension, or other 4. Are There Page Limits or Other Page deadline requirements rest with grants Responsibility Matters; officer to be determined, the ASPE Guidelines for the Narrative Section of 11. Certification and, if necessary, the Application Grants Management Officer. Disclosure Regarding Lobbying; C. Disposition of Applications 12. Supplement to Section II—Key Yes, there are page limits for the Personnel; applications. Applicants are requested 1. Approval, disapproval, or deferral. 13. Application for Federal Assistance On the basis of the review of the to be concise. The announcement Checklist. application, the Assistant Secretary will indicates that applications are not Standard forms are available from either (a) approve the application as a expected to be lengthy (see Part III, GRANTS OFFICER TO BE whole or in part; (b) disapprove the Section C). Applications must be no DETERMINED or may be obtained application; or (c) defer action on the longer than 20 pages. Applications must electronically from the ASPE world application for such reasons as lack of be typed in 12 point font size, with wide web site: http://aspe.hhs.gov/ funds or a need for further review. single line spacing, and 1 inch top, 2. Notification of disposition. The funding.htm bottom, right, and left margins. Assistant Secretary for Planning and Part V. Questions and Answers Applications that exceed the page limits Evaluation will notify the applicants of and other guidelines will not be the disposition of their applications. If 1. Who May Submit an Application considered. approved, a signed notification of the Under This Announcement? 5. Where Should Applications To Be award will be sent to the business office State agencies that received ASPE Sent? named in the ASPE checklist. State Innovation Planning grants in FY 3. The Assistant Secretary’s 2002 are eligible to apply. An original and two copies of the Discretion. Nothing in this The following planning grantees are complete application should be sent to: announcement should be construed as eligible to apply for an FY 2003 ASPE To be determined. to obligate the Assistant Secretary for State Innovation Demonstration grant: Planning and Evaluation to make any (1) Alaska Department of Health and 6. What Is the Application Submission awards whatsoever. Awards and the Social Services—‘‘Planning for Deadline? distribution of awards among the Comprehensive Early Childhood Mental priority areas are contingent on the Health in Alaska’’; (2) Arizona Applications must be received or needs of the Department at any point in Department of Health Services— postmarked by August 18, 2003. time and the quality of the applications ‘‘Arizona Diabetic Patient Self- 7. What Is the Deadline for Applications that are received. Management Project’’; (3) Arkansas Sent via Overnight Courier Services? D. Components of a Complete Department of Human Services— Application ‘‘Improving Transitions from the Applications that are hand-carried Institutions into the Community’’; (4) will be considered as meeting the A complete application consists of the Delaware Health and Social Services— deadline if they are received on or following items in this order: ‘‘Self-Directed Supports for Community before the deadline date between the 1. Application for Federal Assistance Living’’; (5) District of Columbia hours of 8 a.m. and 4:30 p.m. EST at (Standard Form 424); NICHD, Grants Management Branch, 2. Budget Information—Non- Department of Health—‘‘DC Youth construction Programs (Standard Form Violence Prevention Initiative—’’; (6) U.S. Department of Health and Human 424A); Iowa Department of Human Services— Services, 6100 Executive Boulevard, 3. Assurances—Non-construction ‘‘Healthy Marriage/Responsible Room 8A01 Bethesda, Maryland 20892– Programs (Standard Form 424B); Fatherhood’’; (7) Kansas Department of 7510 (Regular Mail) or Rockville, 4. Table of Contents; Social and Rehabilitation Services— Maryland 20852 (Express Mail), Phone: 5. Budget Justification for Section B ‘‘Child Welfare Wrap Around Service (301) 435–6997, Fax: (301) 402–0915. Budget Categories; Delivery’’; (8) Maryland Department of The address must include the 6. Proof of Non-profit Status, if Aging—‘‘Changing Interagency Service designation: ‘‘Attention: Grants Officer appropriate; Delivery Systems to Help Older Public To Be Determined.’’ (Applicants are 7. Copy of the applicant’s Approved Housing Residents’’; (9) New Hampshire cautioned that express/overnight mail Indirect Cost Rate Agreement, if State Department of Health and Human services do not always deliver as necessary; Services—‘‘Granite State Data Archive’’; agreed.)

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8. May Applications Be Faxed or Sent proposed projects or to obtain a copy of modified and are being merged to create Electronically? the data collection plans and the NHSN. The NHSN will evolve with No. Applications transmitted by fax or instruments, call the CDC Reports the addition of modules and through other electronic means will not Clearance Officer on (404) 498–1210. participating healthcare institutions Comments are invited on: (a) Whether be accepted regardless of date or time of from a wide spectrum of settings. the proposed collection of information submission or receipt. The NHSN is a knowledge system for is necessary for the proper performance accumulating, exchanging, and 9. Where Can Additional Copies of the of the functions of the agency, including integrating relevant information and Announcement and/or Forms Be whether the information shall have resources among private and public Obtained? practical utility; (b) the accuracy of the stakeholders to support local and agency’s estimate of the burden of the The complete package, announcement national efforts to protect patients and proposed collection of information; (c) and standard forms, may be obtained by to promote healthcare safety. ways to enhance the quality, utility, and calling to be determined. Specifically, the data will be used to clarity of the information to be determine the magnitude of various Dated: June 9, 2003. collected; and (d) ways to minimize the healthcare-associated adverse events William F. Raub, burden of the collection of information and trends in the rates of these events on respondents, including through the Acting Assistant Secretary for Planning and among patients and healthcare workers Evaluation. use of automated collection techniques with similar risks. They will be used to or other forms of information [FR Doc. 03–15385 Filed 6–17–03; 8:45 am] detect changes in the epidemiology of technology. Send comments to Seleda BILLING CODE 4154–05–M adverse events resulting from new and Perryman, CDC Assistant Reports current medical therapies and changing Clearance Officer, 1600 Clifton Road, DEPARTMENT OF HEALTH AND MS–D24, Atlanta, GA 30333. Written risks. HUMAN SERVICES comments should be received within 60 Healthcare institutions that days of this notice. participate in NHSN voluntarily report Centers for Disease Control and Proposed Project: National Healthcare their data to the Division of Healthcare Prevention Safety Network (NHSN)—New— Quality Promotion in the National National Center for Infectious Disease Center for Infectious Diseases at the [60Day–03–79] (NCID), Centers for Disease Control and Centers for Disease Control and Proposed Data Collections Submitted Prevention (CDC). OMB first approved Prevention through the National for Public Comment and the information collection now known Electronic Disease Surveillance System Recommendations as the ‘‘National Nosocomial Infections that uses a web browser-based Surveillance (NNIS) System’’ (OMB technology for data entry and data In compliance with the requirement No.0920–0012) in 1970; it approved the management. Data are collected by of section 3506(c)(2)(A) of the ‘‘National Surveillance System for trained surveillance personnel using Paperwork Reduction Act of 1995 for Healthcare Workers(NaSH)’’ (OMB written standardized protocols. The cost opportunity for public comment on 0920–0417) in 1997, and the to participating institutions is a proposed data collection projects, the ‘‘Surveillance for Bloodstream and computer capable of supporting an Centers for Disease Control and Vascular Access Infections in internet service provider (ISP) and Prevention (CDC) will publish periodic Outpatient Hemodialysis Centers’’ access to an ISP. The table below shows summaries of proposed projects. To (OMB No. 0920–0442) in 1999. These the estimated annual burden in hours to request more information on the three data collections have been collect and report data.

Number of Burden per Title Number of responses/ response Total burden respondents respondent (in hrs.) (hrs.)

NHSN Application/Annual Survey ...... 350 1 1 350 Dialysis Application/Annual Survey ...... 80 1 1 80 Patient Safety Monthly Reporting Plan ...... 350 9 25/60 1,313 Patient Data ...... 350 111 5/60 3,238 Surgical Site Infection (SSI) ...... 200 27 25/60 2,250 Pneumonia (PNEU) ...... 200 54 25/60 4,500 Primary Bloodstream Infection (BSI) ...... 230 54 25/60 5,175 Urinary Tract Infection (UTI) ...... 150 45 25/60 2,813 Dialysis Incident (DI) ...... 80 90 12/60 1,440 Denominator for Procedure ...... 200 540 5/60 9,000 Denominator for Specialty Care Area (SCA) ...... 75 9 5 3,375 Denominator for Neonatal Intensive Care Unit (NICU) ...... 100 9 4 3,600 Denominator for Intensive Care Unit (ICU)/Other locations (Not NICU or SCA) ...... 245 18 5 22,050 Denominator for Outpatient ...... 80 9 5/60 60 Antimicrobia 1 Use and Resistance (AUR)—Pharmacy ...... 20 36 2 1,440 Healthcare Personnel Safety Reporting Plan ...... 90 2 10/60 30 Healthcare Personnel Exposures to Blood/Body Fluids ...... 90 42 1 3,780 Healthcare Personnel Post-exposure Prophylaxis ...... 90 6 15/60 135 Healthcare Personnel Demographic Data ...... 90 42 10/60 630 Healthcare Personnel Vaccination History ...... 90 42 15/60 945 Healthcare Personnel Facility Survey ...... 90 1 6 540 Healthcare Personnel Implementation of Engineering Controls ...... 90 1 6 540 Healthcare Personnel Survey ...... 30 1 10/60 5

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Number of Burden per Title Number of responses/ response Total burden respondents respondent (in hrs.) (hrs.)

Total ...... 67,289

Dated: June 12, 2003. porcupines (Atherurus sp.), Striped involved in the outbreak will likely Thomas A. Bartenfeld, mice (Hybomys sp.). change as the investigation continues. Acting Associate Director for Policy, Planning This prohibition does not apply to Onset of illness among patients began and Evaluation, Centers for Disease Control individuals who transport listed in early May. All patients reported and Prevention. animals to veterinarians or animal direct or close contact with Prairie dogs, [FR Doc. 03–15330 Filed 6–17–03; 8:45 am] control officials or other entities most of which were sick. In May, the BILLING CODE 4163–18–P pursuant to guidance or instructions Prairie dogs were sold by a Milwaukee issued by Federal, State, or local animal distributor to two pet shops in government authorities. the Milwaukee area and during a pet ‘‘swap meet’’ (pets for sale or exchange) DEPARTMENT OF HEALTH AND This action is being taken because at in northern Wisconsin. The Milwaukee HUMAN SERVICES least six different species of potentially animal distributor had obtained Prairie infected rodents have been implicated Centers for Disease Control and dogs and a Gambian giant rat that was in the current outbreak of monkeypox Prevention ill at the time from a northern Illinois virus in humans. Monkeypox virus was animal distributor. On the basis of also subsequently transmitted from Food and Drug Administration preliminary findings from the trace-back infected rodents to native Prairie dogs. investigation of the Prairie dogs and the RIN 0920–AA03 Based on epidemiologic and scientific Gambian giant rat, it appears that the knowledge gathered to date, specific source of the infection was a shipment Control of Communicable Diseases interstate restrictions on the species of rodents from Africa, which included within these genera are required to AGENCIES: Centers for Disease Control six distinct species of rodents. It appears contain further movement of implicated and Prevention (CDC), Food and Drug that the primary route of transmission animals. A ban on the intrastate sale or Administration (FDA), Department of may be from infected rodents from offering for sale or offering for any other Health and Human Services (HHS). Africa to native Prairie dogs and then to type of commercial or public ACTION: Notice of embargo and humans as a result of close contact. prohibition on transportation or offering distribution of the species within these II. Public Health Risks for transportation in interstate genera is also necessary because of the commerce, or sale, offering for sale, or potential impact on interstate disease Monkeypox is a rare zoonotic viral offering for any other type of spread. Furthermore, a ban on the disease that occurs primarily in the rain commercial or public distribution, importation of shipments of all rodents forest countries of central and west including release into the environment, from Africa is necessary to mitigate the Africa. Studies have shown that rodents of certain rodents and Prairie dogs. harm of further introductions of from Africa are capable of transmitting monkeypox virus into the United States. monkeypox virus in humans. In SUMMARY: Shipments of rodents (order DATES: This embargo and prohibition is humans, the illness produces a vesicular Rodentia) from Africa capable of effective on June 11, 2003, and will and pustular rash similar to that of transmitting monkeypox virus in remain in effect until further notice. smallpox. Limited person-to-person humans are being imported into the FOR FURTHER INFORMATION CONTACT: spread of infection has been reported in United States and further distributed. In Thomas A. Demarcus, National Center disease-endemic areas in Africa; the the United States, Prairie dogs incubation period is about 12 days. (Cynomys sp.) and certain rodents from for Infectious Diseases (E03), Centers for Disease Control and Prevention, 1600 Case-fatality ratios in Africa have ranged Africa may further transmit the from 1 percent to 10 percent. It is likely monkeypox virus in humans. Clifton Road, NE., Atlanta, GA 30333, 770–488–7100, or Gloria Dunnavan, the virus entered the United States via Because of the public health threat imported rodent species from Africa. posed by the importation of rodents Division of Compliance, Office of Surveillance and Compliance, Center for Further transmission of the virus likely from Africa, CDC is implementing an occurred in the storage and handling of immediate embargo on the importation Veterinary Medicine, Food and Drug Administration, 7500 Standish Place these imported rodents during sale and of all rodents (order Rodentia) from distribution within the United States. Africa until further notice. In addition, (HFV–230), Rockville, MD 20855, 301– 827–1168. This resulted in secondary transmission as a public health measure, CDC and to domestic Prairie dogs housed in the FDA are prohibiting, until further SUPPLEMENTARY INFORMATION: same animal-holding facility or pet notice, the transportation or offering for I. Background shop. transportation in interstate commerce, or the sale or offering for sale, or As of June 10, a total of 50 persons III. Immediate Action offering for any other type of with suspected monkeypox had been Introduction of exotic species, such as commercial or public distribution, reported from Wisconsin, Illinois, rodents from Africa, poses a serious including release into the environment, Indiana, and New Jersey. Monkeypox public health threat because of the of Prairie dogs and the following had been confirmed by laboratory tests potential of human monkeypox virus rodents from Africa: Tree squirrels in four persons. Seven of the people infection. Transportation in interstate (Heliosciurus sp.); Rope squirrels with suspected monkeypox had been commerce or sale or any other type of (Funisciurus sp.); Dormices (Graphiurus hospitalized for their illness; there have commercial or public distribution, sp.); Gambian Giant Pouched Rats been no deaths related to the outbreak. including release into the environment, (Cricetomys sp.); Brush-tailed The number of cases and States of species of rodents linked to the initial

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infected shipment and Prairie dogs that a temporary permit has been issued and 130. The permit is effective for 15 poses a serious public health threat to Chiquita Processed Foods, LLC, and months, beginning on the date the test because of the potential for further Crown Cork & Seal Co., to market test product is introduced or caused to be spread of the monkeypox virus to other a product designated as ‘‘VERI-GREEN introduced into interstate commerce, species and humans. Cut Asparagus Spears’’ that deviates but not later than September 16, 2003. The scope of this communicable from the U.S. standard of identity for Dated: June 10, 2003. disease problem is inherently and canned asparagus. The purpose of the Jeffrey Shuren, necessarily an interstate problem that temporary permit is to allow the Assistant Commissioner for Policy. cannot be controlled by individual state applicant to measure consumer [FR Doc. 03–15403 Filed 6–17–03; 8:45 am] health authorities. Thus, the appropriate acceptance of the food. BILLING CODE 4160–01–S measures taken by the health authorities DATES: This permit is effective for 15 of any state or possession are months, beginning on the date the test insufficient to prevent the interstate product is introduced or caused to be DEPARTMENT OF HEALTH AND spread of human monkeypox virus introduced into interstate commerce, HUMAN SERVICES infection. Accordingly, CDC and FDA, but no later than September 16, 2003. pursuant to 42 CFR 70.2 and 21 CFR FOR FURTHER INFORMATION CONTACT: National Institutes of Health 1240.30, are prohibiting, until further Catalina Ferre-Hockensmith, Center for notice, the transportation or offering for Food Safety and Applied Nutrition Proposed Collection; Comment transportation in interstate commerce, (HFS–820), Food and Drug Request; Physicians’ Experience of or the sale, offering for sale, or offering Administration, 5100 Paint Branch Ethical Dilemmas and Resource for any other type of commercial or Pkwy., College Park, MD 20740, 301– Allocation public distribution, including release 436–2371. SUMMARY: In compliance with the into the environment, of Prairie dogs SUPPLEMENTARY INFORMATION: In requirement of section 3506(c)(2)(A) of and the following rodents from Africa: accordance with 21 CFR 130.17 the Paperwork Reduction Act of 1995, Tree squirrels (Heliosciurus sp.); Rope concerning temporary permits to for opportunity for public comment on squirrels (Funisciurus sp.); Dormices facilitate market testing of foods proposed data collection projects, the (Graphiurus sp.); Gambian Giant deviating from the requirements of the National institute of Dental and Pouched Rats (Cricetomys sp.); Brush- standards of identity issued under Craniofacial Research (NIDCR), the tailed porcupines (Atherurus sp.), section 401 of the Federal Food, Drug, National Institutes of Health (NIH) will Striped mice (Hybomys sp.). and Cosmetic Act (21 U.S.C. 341), FDA publish periodic summaries of proposed This prohibition does not apply to is giving notice that a temporary permit projects to be submitted to the Office of individuals who transport listed has been issued to Chiquita Processed Management and Budget (OMB) for animals to veterinarians or animal Foods, LLC, P.O. Box 458, Walla Walla, review and approval. control officials or other entities WA 99362, and to Crown Cork & Seal Proposed Collection: Title: pursuant to guidance or instructions Co., 11535 South Central Ave., Alsip, IL Physicians’ Experience of Ethical issued by Federal, State, or local 60803. Dilemmas and Resource Allocation. government authorities. In addition, The permit covers limited interstate Type of Information Collection Request: pursuant to 42 CFR 71.32(b), CDC is marketing tests of a product designated New. Need and Use of Information implementing an immediate embargo on as ‘‘VERI-GREEN Cut Asparagus Spears’’ Collection: Health care costs are rising the importation of all rodents from that deviates from the U.S. standard of ceaselessly and there are currently no Africa (order Rodentia). identity for canned asparagus (21 CFR generally accepted way of controlling Dated: June 12, 2003. 155.200) in that the test product will them. This study will access the Julie Louise Gerberding, contain added zinc chloride and experience of physicians regarding Director, Centers for Disease Control and stannous chloride at a maximum level resource allocation in clinical practice, Prevention. of 75 parts per million (ppm) of zinc and how allocation decisions made at Dated: June 12, 2003. and 35 ppm of stannous chloride in the other levels shapes this experience. The Mark B. McClellan, finished food. The test product meets all primary objectives of the study are to determine if physicians make decisions Commissioner of Food and Drugs. requirements of the standard with the exception of the variation. The purpose to withhold interventions on the basis of [FR Doc. 03–15423 Filed 6–13–03; 5:07 pm] of the variance is to test the use of cost, how often they report doing so, BILLING CODE 4160–01–P added zinc chloride and stannous what types of care are withheld, and chloride to retain the green color of the what criteria are used in making such DEPARTMENT OF HEALTH AND food and fresh taste. decisions. The findings will provide HUMAN SERVICES The permit provides for the temporary valuable information concerning: (1) marketing of 387,192 pounds (lb) of the The practice if resource allocation in Food and Drug Administration test product (175,200 kilograms (kg)) clinical practice, (2) the possible effects (10,000 cases, each containing 6 lb, 7 of perceived constraints on this practice, [Docket No. 2003N–0234] ounce (2.92 kg) cans). The product will and (3) international comparisons on these two aspects. Frequency of Canned Asparagus Deviating From be manufactured at Chiquita Processed Response: Once. Affected Public: Identity Standard; Temporary Permit Foods, LLC, 516 West Rose, Walla Individuals or households; businesses for Market Testing Walla, WA 99362. The product will be distributed in the United States. or other for-profit; not-for-profit AGENCY: Food and Drug Administration, For the purpose of the permit, the institutions. Type of Respondents: HHS. name of the product is ‘‘VERI-GREEN Physicians. The annual reporting ACTION: Notice. Cut Asparagus Spears.’’ Each of the burden is as follows: Estimated number ingredients used in the food must be of Respondents: 250; Estimated Number SUMMARY: The Food and Drug declared on the label as required by the of Responses per Respondent: 1; Administration (FDA) is announcing applicable sections of 21 CFR parts 101 Average Burden Hours Per Response:

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.0.3674; and Estimated Total Annual is hereby given of the following Name of Committee: National Institute of Burden Hours Requested: 91.85. The meeting. General Medical Sciences Special Emphasis Panel, National Research Service Award. annualized cost to respondents is The meeting will be closed to the estimated at: $5,218. There are no Date: July 15, 2003. public in accordance with the Time: 8 a.m. to 6 p.m. capital costs, operating costs and/or provisions set forth in sections Agenda: To review and evaluate grant maintenance costs to report. 552b(c)(4) and 552b(c)(6), Title 5 U.S.C., applications. Request for Comments: Written as amended. The grant applications and Place: Holiday Inn Select Bethesda, 8120 comments and/or suggestions from the the discussions could disclose Wisconsin Ave, Bethesda, MD 20814. public and affected agencies are invited confidential trade secrets or commercial Contact Person: Brian R. Pike, PhD, Scientific Review Administrator, Office of on one or more of the following points: property such as patentable material, (1) Whether the proposed collection of Scientific Review, National Institute of and personal information concerning General Medical Sciences, National Institutes information is necessary for the proper individuals associated with the grant of Health, Natcher Building, Room 3AN–18K, performance of the function of the applications, the disclosure of which Bethesda, MD 20892, 301–594–3907, agency, including whether the would constitute a clearly unwarranted [email protected]. information will have practical utility; invasion of personal privacy. (Catalogue of Federal Domestic Assistance (2) the accuracy of the agency’s estimate Program Nos. 93.375, Minority Biomedical Name of Committee: National Human of the burden of the proposed collection Research Support; 93.821, Cell Biology and Genome Research Institute Special Emphasis of information, including the validity of Biophysics Research; 93.859, Pharmacology, Panel, ENCODE Determination and Physiology, and Biological Chemistry the methodology and assumptions used; Technology. (3) ways to enhance the quality, utility, Research; 93.862, Genetics and Date: July 14–15, 2003. Developmental Biology Research; 93.88, and clarity of the information to be Time: 8:30 a.m. to 5 p.m. collected; and (4) ways to minimize the Minority Access to Research Careers; 93.86, Agenda: To review and evaluate grant Special Minority Initiatives, National burden of the collection of information applications. Institutes of Health, HHS) on those who are to respond, including Place: Hyatt Regency Bethesda, One the use of appropriate automated, Bethesda Metro Center, 7400 Wisconsin Dated: June 10, 2003. electronic, mechanical, or other Avenue, Bethesda, MD 20814. Anna P. Snouffer, technological collection techniques or Contact Person: Rudy O. Pozzatti, PhD, Acting Director, Office of Federal Advisory other forms of information technology. Scientific Review Administrator, Office of Committee Policy. Scientific Review, National Human Genome [FR Doc. 03–15373 Filed 6–17–03; 8:45 am] FOR FURTHER INFORMATION CONTACT: To Research Institute, National Institutes of BILLING CODE 4140–01–M request more information on the Health, Bethesda, MD 20892, 301–402–0838. proposed project or to obtain a copy of (Catalogue of Federal Domestic Assistance the data collection plans and Program Nos. 93.172, Human Genome DEPARTMENT OF HEALTH AND instruments, contact Dr. Samia Hurst, Research, National Institutes of Health, HHS) HUMAN SERVICES Department of Clinical Bioethics, Dated: June 10, 2003. Building 10, room 1C118, National National Institutes of Health Institutes of Health, Bethesda, MD Anna P. Snouffer, 20892, or call non-toll-free number (301) Acting Director, Office of Federal Advisory National Institute of Child Health and 435–8713 or E-mail your request, Committee Policy. Human Development; Notice of Closed including your address to: [FR Doc. 03–15374 Filed 6–17–03; 8:45 am] Meeting [email protected]. BILLING CODE 4140–01–M Pursuant to section 10(d) of the Comments Due Date: Comments Federal Advisory Committee Act, as regarding this information collection are amended (5 U.S.C. appendix 2), notice best assured of having their full effect if DEPARTMENT OF HEALTH AND is hereby given of the following received within 60-days of the date of HUMAN SERVICES meeting. this publication. National Institutes of Health The meeting will be closed to the Dated: May 29, 2003. public in accordance with the David K. Henderson, National Institute of General Medical provisions set forth in sections Deputy Director, Warren G. Magnuson Sciences; Notice of Closed Meeting 552b(a)(4) and 552b(c)(6), Title 5 U.S.C., Clinical Center, National Institutes of Health. as amended. The contract proposals and Ezekiel J. Emanuel, Pursuant to section 10(d) of the the discussions could disclose Director, Department of Clinical Bioethics, Federal Advisory Committee Act, as confidential trade secrets or commercial Warren G. Magnuson Clinical Center, amended (5 U.S.C. appendix 2), notice property such as patentable material, National Institutes of Health. is hereby given of the following and personal information concerning [FR Doc. 03–15372 Filed 6–17–03; 8:45 am] meeting. individuals associated with the contract BILLING CODE 4140–01–M The meeting will be closed to the proposals, the disclosure of which public in accordance with the would constitute a clearly unwarranted provisions set forth in sections invasion of personal privacy. DEPARTMENT OF HEALTH AND 552b(c)(4) and 552b(c)(6), Title 5 U.S.C., Name of Committee: National Institute of HUMAN SERVICES as amended. The grant applications and Child Health and Human Development the discussions could disclose Special Emphasis Panel, RFP–NICHD–2003– National Institutes of Health confidential trade secrets or commercial 12 ‘‘Determinants of Male and Female property such as patentable material, Fecundity and Fertility’’. National Human Genome Research Date: July 14, 2003. Institute; Notice of Closed Meeting and personal information concerning Time: 8 a.m. to 2 p.m. individuals associated with the grant Agenda: To review and evaluate contract Pursuant to section 10(d) of the applications, the disclosure of which proposals. Federal Advisory Committee Act, as would constitute a clearly unwarranted Place: Ramada Inn Rockville, 1775 amended (5 U.S.C. appendix 2), notice invasion of personal privacy. Rockville Pike, Rockville, MD 20852.

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Contact Person: Hameed Khan, PhD, Infertility Loan Repayment Program, National Dated: June 10, 2003. Scientific Review Administrator, Division of Institutes of Health, HHS) Anna P. Snouffer, Scientific Review, National Institute of Child Health and Human Development, National Dated: June 10, 2003. Acting Director, Office of Federal Advisory Institutes of Health, 6100 Executive Blvd., Anna P. Snouffer, Committee Policy. Room 5E01, Bethesda, MD 20892, (301) 435– Acting Director, Office of Federal Advisory [FR Doc. 03–15377 Filed 6–17–03; 8:45 am] 6902, khanh2mail.nih.gov. Committee Policy. BILLING CODE 4140–01–M (Catalogue of Federal Domestic Assistance [FR Doc. 03–15376 Filed 6–17–03; 8:45 am] Program Nos. 93.864, Population Research; 93.865, Research for Mothers and Children; BILLING CODE 4140–01–M DEPARTMENT OF HEALTH AND 93.929, Center for Medical Rehabilitation HUMAN SERVICES Research; 93.209, Contraception and DEPARTMENT OF HEALTH AND Infertility Loan Repayment Program, National National Institutes of Health Institutes of Health, HHS) HUMAN SERVICES Dated: June 10, 2003. National Institute of General Medical National Institutes of Health Anna P. Snouffer, Sciences; Notice of Closed Meeting Acting Director, Office of Federal Advisory National Institute of Mental Health; Committee Policy. Pursuant to section 10(d) of the Notice of Closed Meeting [FR Doc. 03–15375 Filed 6–17–03; 8:45 am] Federal Advisory Committee Act, as amended (5 U.S.C. appendix 2), notice BILLING CODE 4140–01–M Pursuant to section 10(d) of the is hereby given of the following Federal Advisory Committee Act, as meeting. amended (5 U.S.C. appendix 2), notice DEPARTMENT OF HEALTH AND The meeting will be closed to the HUMAN SERVICES is hereby given of the following meeting. public in accordance with the National Institutes of Health provisions set forth in sections The meeting will be closed to the 552b(c)(4) 552b(c)(6), Title 5 U.S.C., as public in accordance with the National Institute of Child Health and amended. The grant applications and provisions set forth in sections Human Development; Notice of Closed the discussions could disclose 552b(c)(4) and 552b(c)(6), Title 5 U.S.C., Meeting confidential trade secrets or commercial as amended. The grant applications and property such as patentable material, Pursuant to section 10(d) of the the discussions could disclose and personal information concerning Federal Advisory Committee Act, as confidential trade secrets or commercial individuals associated with the grant amended (5 U.S.C. appendix 2), notice property such as patentable material, applications, the disclosure of which is hereby given of the following and personal information concerning would constitute a clearly unwarranted meeting. individuals associated with the grant invasion of personal privacy. The meeting will be closed to the applications, the disclosure of which public in accordance with the Name of Committee: National Institute of would constitute a clearly unwarranted General Medical Sciences Special Emphasis provisions set forth in sections invasion of personal privacy. 552b(c)(4) and 552(c)(6), Title 5 U.S.C., Panel, Initiative for Minority Student as amended. The contract proposals and Name of Committee: National Institute of Development. the discussions could disclose Mental Health Special Emphasis Panel, ITV Date: July 14–15, 2003. confidential trade secrets or commercial Conflicts Cooperative Agreements. Time: 8:30 a.m. to 12 p.m. property such as patentable material, Date: June 19, 2003. Agenda: To review and evaluate grant applications. and personal information concerning Time: 11 a.m. to 12 p.m. Place: Holiday Inn Select Bethesda, 8120 individuals associated with the contract Agenda: To review and evaluate Wisconsin Ave., Bethesda, MD 20814. proposals, the disclosure of which cooperative agreement applications. Contact Person: N. Kent Peters, PhD, would constitute a clearly unwarranted Place: National Institutes of Health, Scientific Review Administrator, Office of invasion of personal privacy. Neuroscience Center, 6001 Executive Boulevard, Rockville, MD 20852, (Telephone Scientific Review, National Institute of Name of Committee: National Institute of Conference Call). General Medical Sciences, National Institutes Child Health and Human Development Contact Person: Martha Ann Carey, PhD, of Health, 45 Center Drive, Room 18ANK, Special Emphasis Panel, RFP–NICHD–2003– RN, Scientific Review Administrator, Bethesda, MD 20892, (301) 594—2408, 02—BPCA Coordinating Center Review. [email protected]. Date: July 16, 2003. Division of Extramural Activities, National Time: 8 a.m. to 5 p.m. Institute of Mental Health, NIH, (Catalogue of Federal Domestic Assistance, Agenda: To review and evaluate contract Neuroscience Center, 6001 Executive Blvd., Program Nos. 93.375, Minority Biomedical proposals. Room 6151, MSC 9608, Bethesda, MD 20892– Research Support; 93.821, Cell Biology and Place: National Institutes of Health, 6100 9608, 301–443–1606, [email protected]. Biophysics Research; 93.859, Pharmacology, Executive Boulevard, Rockville, MD 20552, This notice is being published less than 15 Physiology, and Biological Chemistry (Telephone Conference Call). days prior to the meeting due to the timing Research; 93.862, Genetics and Contact Person: Hameed Khan, PhD, limitations imposed by the review and Developmental Biology Research; 93.88, Scientific Review Administrator, Division of funding cycle. Scientific Review, National Institute of Child Minority Access to Research Careers; 93.96, Health and Human Development, National (Catalogue of Federal Domestic Assistance Special Minority Initiatives, National Institutes of Health, 6100 Executive Blvd., Program Nos. 93.242, Mental Health Research Institutes of Health, HHS) Room 5E01, Bethesda, MD 20892, (301) 435– Grants; 93.281, Scientist Development Dated: June 11, 2003. 6902, [email protected]. Award, Scientist Development Award for Anna P. Snouffer, (Catalogue of Federal Domestic Assistance Clinicians, and Research Scientist Award; Acting Director, Office of Federal Advisory Program Nos. 93.864, Population Research; 93.282, Mental Health National Research Committee Policy. 93.865, Research for Mothers and Children; Service Awards for Research Training, [FR Doc. 03–15378 Filed 6–17–03; 8:45 am] 93.929, Center for Medical Rehabilitation National Institutes of Health, HHS) Research; 93.209, Contraception and BILLING CODE 4140–01–M

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DEPARTMENT OF HEALTH AND is hereby given of the following applications, the disclosure of which HUMAN SERVICES meeting. would constitute a clearly unwarranted The meeting will be closed to the invasion of personal privacy. National Institutes of Health public in accordance with the Name of Committee: National Institute on provisions set forth in sections Drug Abuse Special Emphasis Panel, National Institute of General Medical 552b(c)(4) and 552b(c)(6), title 5 U.S.C., Training and Career Development Sciences; Notice of Closed Meeting as amended. The grant applications and Subcommittee. Pursuant to section 10(d) of the the discussions could disclose Date: July 16, 2003. Federal Advisory Committee Act, as confidential trade secrets or commercial Time: 1 p.m. to 4 p.m. Agenda: To review and evaluate grant amended (5 U.S.C. appendix 2), notice property such as patentable material, and personal information concerning applications. is hereby given of the following Place: Ritz-Carlton Hotel at Pentagon City, meeting. individuals associated with the grant applications, the disclosure of which 1250 South Hayes Street, Arlington, VA The meeting will be closed to the 22202. public in accordance with the would constitute a clearly unwarranted invasion of personal privacy. Contact Person: Elaine Lazar-Wesley, provisions set forth in sections Health Scientist Administrator, Office of 552b(c)(4) and 552b(c)(6), Title 5 U.S.C., Name of Committee: National Institute of Extramural Affairs, National Institute on as amended. The grant applications and Diabetes and Digestive and Kidney Diseases Drug Abuse, National Institutes of Health, the discussions could disclose Special Emphasis Panel, Bariatric Surgery DHHS, 6001 Executive Boulevard, Room Clinical Research Consortium. confidential trade secrets or commercial 3158, MSC 9547, Bethesda, MD 20892–9547, Date: July 24–25, 2003. 301–451–4530. property such as patentable material, Time: 8 a.m. to 5 p.m. and personal information concerning Agenda: To review and evaluate grant Name of Committee: National Institute on individuals associated with the grant applications. Drug Abuse Special Emphasis Panel, applications, the disclosure of which Place: Courtyard by Marriott, 2899 Transdisciplinary Prevention Research would constitute a clearly unwarranted Jefferson Davis Highway, Arlington, VA Centers. invasion of personal privacy. 22202. Date: July 17–18, 2003. Contact Person: Paul A. Rushing, PhD, Time: 8:30 a.m. to 5 p.m. Name of Committee: Minority Programs Scientific Review Administrator, Review Agenda: To review and evaluate grant Review Committee, MBRS Review Branch, DEA, NIDDK, Room 747, 6706 applications. Subcommittee B. Democracy Boulevard, National Institutes of Date: July 10–11, 2003. Place: Ritz-Carlton Hotel at Pentagon City, Health, Bethesda, MD 20892. (301) 594–8895. 1250 South Hayes Street, Arlington, VA Time: 8:30 a.m. to 12 p.m. [email protected]. Agenda: To review and evaluate grant 22202. applications. (Catalogue of Federal Domestic Assistance Contact Person: Mark R. Green, PhD, Chief, Place: Holiday Inn Select Bethesda, 8120 Program Nos. 93.847, Diabetes, CEASRB, Office of Extramural Affairs, Wisconsin Ave., Bethesda, MD 20814. Endocrinology and Metabolic Research; National Institute on Drug Abuse, National 93.848, Digestive Diseases and Nutrition Contact Person: Shiva P. Singh, PhD, Institutes of Health, DHHS, Room 3158, MSC Research; 93.849, Kidney Diseases, Urology Office of Scientific Review, National Institute 9547, 6001 Executive Boulevard, Bethesda, and Hematology Research, National Institutes of General Medical Sciences, National MD 20892–9547, (301) 435–1431. of Health, HHS.) Institutes of Health, Natcher Building, Room Name of Committee: National Institute on Dated: June 11, 2003. 1AS–13J, Bethesda, MD 20892. Drug Abuse Special Emphasis Panel, Anna Snouffer, (Catalogue of Federal Domestic Assistance Translating Tobacco Addiction Research to Program Nos. 93.375, Minority Biomedical Acting Director, Office of Federal Advisory Treatment. Research Support; 93.821, Cell Biology and Committee Policy. Date: July 21, 2003. Biophysics Research; 93.859, Pharmacology, [FR Doc. 03–15380 Filed 6–17–03; 8:45 am] Time: 8 a.m. to 7 p.m. Physiology, and Biological Chemistry BILLING CODE 4140–01–M Agenda: To review and evaluate grant Research; 93.862, Genetics and applications. Developmental Biology Research; 93.88, Place: Park Hyatt, 1201 24th Street, Minority Access to Research Careers; 93.96, DEPARTMENT OF HEALTH AND Washington, DC 20037. Special Minority Initiatives, National HUMAN SERVICES Contact Person: Khursheed Asghar, PhD, Institutes of Health, HHS) Chief, Basic Sciences Review Branch, Office Dated: June 11, 2003. National Institutes of Health of Extramural Affairs, National Institute on Anna P. Snouffer, Drug Abuse, National Institutes of Health, National Institute on Drug Abuse; Acting Director, Office of Federal Advisory DHHS, 6001 Executive Boulevard, Room Committee Policy. Notice of Closed Meetings 3158, MSC 9547, Bethesda, MD 20892–9547, (301) 443–2620. [FR Doc. 03–15379 Filed 6–17–03; 8:45 am] Pursuant to section 10(d) of the BILLING CODE 4140–01–M Federal Advisory Committee Act, as (Catalogue of Federal Domestic Assistance amended (5 U.S.C. appendix 2), notice Program Nos. 93.277, Drug Abuse Scientist is hereby given of the following Development Award for Clinicians, Scientist DEPARTMENT OF HEALTH AND meetings. Development Awards, and Research Scientist HUMAN SERVICES The meeting will be closed to the Awards; 93.278, Drug Abuse National public in accordance with the Research Service Awards for Research National Institutes of Health Training; 93.279, Drug Abuse Research provisions set forth in sections Programs, National Institutes of Health, HHS) 552b(c)(4) and 552b(c)(6), Title 5 U.S.C., National Institute of Diabetes and Dated: June 10, 2003. Digestive and Kidney Diseases; Notice as amended. The grant applications and Anna P. Snouffer, of Closed Meeting the discussions could disclose confidential trade secrets or commercial Acting Director, Office of Federal Advisory Pursuant to section 10(d) of the property such as patentable material, Committee Policy. Federal Advisory Committee Act, as and personal information concerning [FR Doc. 03–15381 Filed 6–17–03; 8:45 am] amended (5 U.S.C. appendix 2), notice individuals associated with the grant BILLING CODE 4140–01–M

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DEPARTMENT OF HEALTH AND Dated: June 11, 2003. above, to the attention of the Desk HUMAN SERVICES Toian Vaughn, Officer for the Coast Guard. Committee Management Officer, Substance (3) By fax to (a) the Facility at 202– Substance Abuse and Mental Health Abuse and Mental Health Services 493–2251 and (b) OIRA at 202–395– Services Administration Administration. 5806, or e-mail to OIRA at [FR Doc. 03–15340 Filed 6–17–03; 8:45 am] [email protected] attention: Center for Mental Health Services; BILLING CODE 4162–20–P Desk Officer for the Coast Guard. Notice of Meeting (4)(a) Electronically through the Web Pursuant to Pub. L. 92–463, notice is site for the Docket Management System hereby given of the meeting of the DEPARTMENT OF HOMELAND at http://dms.dot.gov. (b) OIRA does not Center for Mental Health Services SECURITY have a Web site on which you can post (CMHS) National Advisory Council in your comments. June 2003. Coast Guard The Facility maintains the public docket for this notice. Comments and A portion of the meeting will be open [USCG 2003–14779] and will include a roll call, general material received from the public, as announcements, a budget update, and Information Collection Under Review well as documents mentioned in this discussions about the President’s New by the Office of Management and notice as being available in the docket, Freedom Commission on Mental Health, Budget (OMB): OMB Control Numbers will become part of this docket and will the Substance Abuse and Mental Health 1625–0070, 1625–0047, and 1625–0084 be available for inspection or copying at Services Administration’s (SAMHSA) room PL–401 (Plaza level), 400 Seventh activities in translating science to AGENCY: Coast Guard, DHS. Street, SW., Washington, DC, between 9 services, SAMHSA/CMHS’ Report to ACTION: Request for comments. a.m. and 5 p.m., Monday through Congress on Co-occurring Disorder, and Friday, except Federal holidays. You SUMMARY: consumer/survivor issues. In addition, In compliance with the may also find this docket on the Internet the meeting will include an orientation Paperwork Reduction Act of 1995, this at http://dms.dot.gov. session for new council members. request for comments announces that Copies of the complete ICRs are Public comments are welcome. Please the Coast Guard has forwarded the three available for inspection and copying in communicate with the individual listed Information Collection Requests (ICRs) public dockets. They are available in as contact below for guidance. If anyone abstracted below to the Office of docket USCG 2003–14779 of the Docket needs special accommodations for Information and Regulatory Affairs Management Facility between 10 a.m. persons with disabilities please notify (OIRA) of the Office of Management and and 5 p.m., Monday through Friday, the contact listed below. Budget (OMB) for review and comment. except Federal holidays; for inspection The meeting will also include the (The Coast Guard has withdrawn a and printing on the internet at http:// review, discussion, and evaluation of fourth ICR (1625–0077) under this dms.dot.gov; and for inspection from the grant applications. Therefore, a portion docket number and will revise it and Commandant (G–CIM–2), U.S. Coast of the meeting will be closed to the resubmit it to OMB for approval Guard, room 6106, 2100 Second Street, public as determined by the SAMHSA separately.) Our ICRs describe the SW., Washington, DC, between 10 a.m. Administrator, in accordance with Title information we seek to collect from the and 4 p.m., Monday through Friday, 5 U.S.C. 552b(c)(6) and 5 U.S.C. App. 2. public. Review and comment by OIRA except Federal holidays. & 10(d). ensures that we impose only paperwork FOR FURTHER INFORMATION CONTACT: A summary of the meeting and a burdens commensurate with our Barbara Davis, Office of Information roster of Council members may be performance of duties. Management, 202–267–2326, for obtained from Ms. Tracey Cooper, DATES: Please submit comments on or questions on this document; Dorothy Committee Management Coordinator, before July 18, 2003. Beard, Chief, Documentary Services CMHS, Room 17–99, Parklawn ADDRESSES: To make sure that your Division, U.S. Department of Building, Rockville, Maryland 20857, comments and related material do not Transportation, 202–366–5149, for telephone (301) 443–1158. enter the docket (USCG 2003–14779) questions on the docket. Substantive program information may more than once, please submit them by SUPPLEMENTARY INFORMATION: be obtained from the contact person only one of the following means: listed below. (1)(a) By mail to the Docket Regulatory History Committee Name: CMHS National Management Facility, U.S. Department This request constitutes the 30-day Advisory Council. of Transportation, room PL–401, 400 notice required by OIRA. The Coast Meeting Date: June 25–26, 2003. Seventh Street, SW., Washington, DC Guard has already published (68 FR Place: The Melrose Hotel, 2430 20590–0001. (b) By mail to OIRA, 725 16065 (April 2, 2003)) the 60-day notice Pennsylvania Ave., NW, Washington, 17th Street, NW., Washington, DC required by OIRA. That notice elicited DC 20037. 202–955–6400. 20503, to the attention of the Desk no comments. Type: Officer for the Coast Guard. Caution: Closed: June 25, 2003–8:30 a.m.–10:30 Because of recent delays in the delivery Request for Comments a.m. of mail, your comments may reach the The Coast Guard invites comments on Open: June 25, 2003–11 a.m.–5 p.m. Facility more quickly if you choose one the proposed collections of information Open: June 26, 2003–8:30 a.m.–11:30 of the other means described below. to determine whether the collections are a.m. (2)(a) By delivery to room PL–401 at necessary for the proper performance of FOR FURTHER INFORMATION CONTACT: Dale the address given in paragraph (1)(a) the functions of the Department. In Kaufman, MPH, MA, Executive above, between 9 a.m. and 5 p.m., particular, the Coast Guard would Secretary, 5600 Fishers Lane, Parklawn Monday through Friday, except Federal appreciate comments addressing: (1) Building, Room 17–99, Rockville, holidays. The telephone number is 202– The practical utility of the collections; Maryland 20857, Telephone: (301) 443– 366–9329. (b) By delivery to OIRA, at (2) the accuracy of the Department’s 2660 and FAX (301) 443–1563. the address given in paragraph (1)(b) estimated burden of the collections; (3)

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ways to enhance the quality, utility, and authorized to issue certificates of and Urban Development, 451 Seventh clarity of the information that is the compliance with the ISM Code for the Street, Southwest, Washington, DC subject of the collections; and (4) ways United States. 20410; e-mail [email protected]; to minimize the burden of collection on Form: This collection of information telephone (202) 708–2374. This is not a respondents, including the use of does not require the public to fill out toll-free number. Copies of the proposed automated collection techniques or forms, but does require the information forms and other available documents other forms of information technology. to be in written format to the Coast submitted to OMB may be obtained Comments, to DMS or OIRA, must Guard. from Mr. Eddins. contain the OMB Control Number of the Abstract: This information helps to SUPPLEMENTARY INFORMATION: The ICR addressed. Comments to DMS must determine whether U.S. vessels, subject Department has submitted the proposal contain the docket number of this to SOLAS 74, engaged in international for the collection of information, as request, USCG 2003–14779. Comments trade, are in compliance with that described below, to OMB for review, as to OIRA are best assured of having their treaty. Organizations recognized by the required by the Paperwork Reduction full effect if OIRA receives them 30 or Coast Guard conduct ongoing audits of Act (44 U.S.C. Chapter 35). The Notice fewer days after the publication of this vessels’ and companies’ safety- lists the following information: (1) The request. management-systems Annual Estimated Burden Hours: The title of the information collection Information Collection Request estimated burden is 8,440 hours a year. proposal; (2) the office of the agency to 1. Title: Vessel Identification System. collect the information; (3) the OMB OMB Control Number: 1625–0070. Dated: June 11, 2003. approval number, if applicable; (4) the Type of Request: Extension of a Clifford I. Pearson, description of the need for the currently approved collection. Director of Information and Technology. information and its proposed use; (5) Affected Public: Governments of [FR Doc. 03–15301 Filed 6–17–03; 8:45 am] the agency form number, if applicable; States and territories. BILLING CODE 4910–15–P (6) what members of the public will be Form: This collection of information affected by the proposal; (7) how does not require the public to fill out frequently information submissions will forms, but does require the information DEPARTMENT OF HOUSING AND be required; (8) an estimate of the total to be collected electronically. URBAN DEVELOPMENT number of hours needed to prepare the Abstract: The Coast Guard must information submission including establish a nationwide vessel- [Docket No. FR–4815–N–33] number of respondents, frequency of identification system (VIS) and Notice of Submission of Proposed response, and hours of response; (9) centralize certain vessel-documentation whether the proposal is new, an functions. VIS provides participating Information Collection to OMB: Previous Participation Certification extension, reinstatement, or revision of States and territories with access to data an information collection requirement; on vessels numbered by States and AGENCY: Office of the Chief Information and (10) the name and telephone territories. Participation in it is Officer, HUD. number of an agency official familiar voluntary. ACTION: Notice. with the proposal and of the OMB Desk Annual Estimated Burden Hours: The Officer for the Department. estimated burden is 6,045 hours a year. SUMMARY: The proposed information 2. Title: Vital System Automation. This Notice also lists the following collection requirement described below information: OMB Control Number: 1625–0047. has been submitted to the Office of Type of Request: Extension of a Management and Budget (OMB) for Title of Proposal: Previous currently approved collection. review, as required by the Paperwork Participation Certification. Affected Public: Designers, Reduction Act. The Department is OMB Approval Number: 2502–0118. manufacturers, and owners of vessels soliciting public comments on the and shipyards. Form Numbers: HUD–2530. Form: This collection of information subject proposal. Description of the Need for the does not require the public to fill out DATES: Comments Due Date: July 18, Information and its Proposed Use: The forms, but does require the information 2003. collection of this information aids in to be in written format to the Coast ADDRESSES: Interested persons are protecting HUD’s Multifamily Housing Guard. invited to submit comments regarding Programs by ensuring participation by Abstract: This collection pertains to this proposal. Comments should refer to responsible individuals and the vital-system automation on the proposal by name and/or OMB organizations. HUD evaluates the commercial vessels that is necessary to approval number (2502–0118) and feasibility of applicants with respect to protect personnel and property on board should be sent to: Lauren Wittenberg, their previous track records. U.S.-flag vessels. OMB Desk Officer, Office of Respondents such as owners, managers, Annual Estimated Burden Hours: The Management and Budget, Room 10235, consultants, general contractors, and estimated burden is 57,375 hours a year. New Executive Office Building, nursing home operators and 3. Title: Audit Reports under the Washington, DC 20503; Fax number administrators will be subject to review. International Safety Management Code. (202) 395–6974; e-mail: OMB Control Number: 1625–0084. Respondents: Individuals or [email protected]. Type of Request: Extension of a households, Business or other for-profit, currently approved collection. FOR FURTHER INFORMATION CONTACT: Not-for-profit institutions. Affected Public: Owners and Wayne Eddins, Reports Management Frequency of Submission: On operators of vessels, and organizations Officer, AYO, Department of Housing occasion.

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Number of × Annual × Hours per Burden respondents responses response = hours

Reporting Burden: ...... 4,300 1 0.5 2,150

Total Estimated Burden Hours: 2,150. SUPPLEMENTARY INFORMATION: The of the recovery progress and provide Status: Revision of a currently Department will submit the proposed technical assistance to the PHA. approved collection. information collection to OMB for Following completion of the corrective Authority: Section 3507 of the Paperwork review, as required by the Paperwork action plan, HUD will confirm the Reduction Act of 1995, 44 U.S.C. 35, as Reduction Act of 1995 (44 U.S.C. success of the recovery effort and amended. Chapter 35, as amended). remove the PHA from HUD’s listing of Dated: June 11, 2003. This notice is soliciting comments troubled PHAs. from members of the public and affected Wayne Eddins, Agency form number: HUD–52648. agencies concerning the proposed Members of the Affected Public: Departmental Reports Management Officer, collection of information to: (1) Evaluate Office of the Chief Information Officer. PHAs, State and Local Governments, whether the proposed collection of businesses or other for-profits. [FR Doc. 03–15298 Filed 6–17–03; 8:45 am] information is necessary for the proper BILLING CODE 4210–72–P performance of the functions of the Estimation Including the Total agency, including whether the Number of Hours Needed to Prepare the information will have practical utility; Information Collection for the Number DEPARTMENT OF HOUSING AND (2) evaluate the accuracy of the agency’s of Respondents, Frequency of Response, URBAN DEVELOPMENT estimate of the burden of the proposed and Hours of Response: The number of [Docket No. FR–4817–N–08] collection of information; (3) enhance respondents (2500 PHAs) are required to the quality, utility, and clarity of the submit an electronic SEMAP Notice of Proposed Information information to be collected; and (4) certification to HUD each year within 60 Collection for Public Comment for the minimize the burden of the collection of calendar days following the end of the Section Eight Management information on those who are to PHA’s fiscal year end date. The number Assessment Program (SEMAP) respond; including through the use of of hours that are anticipated regarding the certification process should not AGENCY: Office of the Assistant appropriate automated collection techniques or other forms of information exceed two hours per PHA per year, Secretary for Public and Indian therefore, 5,000 hours. In addition, the Housing. technology, e.g., permitting electronic submissions of responses. number of hours that are anticipated ACTION: Notice. This notice also lists the following regarding the requirement for the PHAs SUMMARY: The proposed information information: to examine samples of tenant file data, collection requirement described below Title of Proposal: Section Eight for quality control purposes, should not will be submitted to the Office of Management Assessment Program exceed 80 hours per PHA per year, Management and Budget (OMB) for (SEMAP). therefore, 200,000 hours. review, as required by the Paperwork OMB Control Number: 2577–0215. Of that number, it is anticipated that Reduction Act. The Department is Description of the Need for the approximately 10 percent or 250 PHAs soliciting public comments on the Information and Proposed Use: Public will be troubled and required to develop subject proposal. Housing Agencies (PHAs) prepare and and implement a corrective active plan. submit an electronic submission to HUD DATES: Comments Due Date: August 18, The number of hours that are that certifies the PHA’s SEMAP 2003. anticipated regarding the development performance in 14 key program areas and implementation of a corrective ADDRESSES: Interested persons are involving the administration and action plan for those PHAs that are invited to submit comments regarding operation of the Housing Choice designated troubled, varies based on the this proposal. Comments should refer to Voucher Program. The certification number and extent of program the proposal by name and/or OMB profile is reviewed by HUD. Following violations at each troubled PHA as well Control Number and should be sent to: review, HUD assigns each PHA an as the extent of correction that will be Mildred M. Hamman, Reports Liaison annual SEMAP score and performance required to remedy the actual violation. Officer, Public and Indian Housing, designation denoting whether the PHA The number of hours that will be Department of Housing & Urban is a High, Standard or Troubled PHA. required for this process are too difficult Development, 451—7th Street, SW., PHAs that are designated High or to estimate. Room 4249, Washington, DC 20410– Standard must correct all cited 5000. Status of the Proposed Information deficiencies within a stand timeframe Collection: Extension is not anticipated FOR FURTHER INFORMATION CONTACT: and may be required to develop a to result in any substantive changes Mildred M. Hamman, (202) 708–0614, corrective action plan to resolve the concerning the foregoing requirements. extension 4128, for copies of the areas of program non-compliance. PHAs proposed forms and other available designated Troubled must submit a Authority: Section 3506 of the Paperwork documents. (This is not a toll-free corrective action plan to HUD for review Reduction Act of 1995, 44 U.S.C. Chapter 35, as amended. number). For hearing- and speech- and approval that outlines the areas of impaired persons, this telephone program non-compliance and details the Dated: June 11, 2003. number may be accessed via TTY (Text corrective strategies the PHA will Michael Liu, telephone) by calling the Federal implement to resolve the cited Assistant Secretary for Public and Indian Information Relay Services at 1–800– deficiencies. During the recovery Housing. 877–8339 (toll-free). process, HUD will monitor the success BILLING CODE 4210–33–P

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[FR Doc. 03–15299 Filed 6–17–03; 8:45 am] FR 81265, Dec. 10, 1980; 48 FR 12446, The major cities in Maricopa County, BILLING CODE 4210–33–C Mar. 24, 1983; 56 FR 29704, Jun. 28, which are the sources of most of the 1991; 57 FR 4470, Feb. 5, 1992; and 57 exchangeable effluent, prefer to FR 48388, Oct. 23, 1992. The above exchange effluent on their own, incur DEPARTMENT OF THE INTERIOR listed notices and decisions were made all related treatment and transportation pursuant to the authority vested in the expenses, and receive any benefits from Office of the Secretary Secretary by the Reclamation Act of the exchange. 1902 as amended and supplemented (32 The notice of proposed modification Central Arizona Project, Arizona; Water Stat. 388, 43 U.S.C. 391), the Boulder of the Secretary of the Interior’s Record Allocations Canyon Project Act of December 21, of Decision to remove the mandatory 1928 (45 Stat. 1057), the Colorado River effluent pooling provision and request AGENCY: Office of the Secretary, Interior. Basin Project Act of September 30, 1968 for comments was published in the ACTION: Notice of final decision to (82 Stat. 885, 43 U.S.C. 1501) and in Federal Register (67 FR 38514, June 4, modify the Secretary of the Interior’s recognition of the Secretary’s trust 2002). Implementation of the proposed record of decision. responsibility to Indian tribes. modification was the only option presented. SUMMARY: The Department hereby issues II. Background notice of its final decision to modify the Following the 1983 CAP Water III. Rationale for Final Decision 1983 Central Arizona Project (CAP) Allocation Decision, the Bureau of The Department favors elimination of Water Allocation Decision to delete the Reclamation, the Central Arizona Water the mandatory effluent pooling mandatory effluent pooling provision. Conservation District (CAWCD), and provision from the 1983 CAP Water As supported by public comment, we each of the non-Indian CAP water Allocation Decision for the following now view that provision as an allottees desiring CAP water entered reasons: impediment to effluent exchanges and into three-party water service (1) In response to public comments effective water management in central subcontracts providing for the delivery submitted by the City of Phoenix in Arizona. The decision that we are of CAP water. In order to ensure 1992 concerning the mandatory effluent publishing in this notice eliminates the implementation of the mandatory pooling provision, the Department requirement for a mandatory effluent effluent pooling provision, municipal committed to re-evaluate this provision pooling provision in CAP water service and industrial (M&I) water service at a later date after consultation with the subcontracts. We will grant the requests subcontractors who choose to Arizona Department of Water Resources by the cities of Chandler and Mesa to circumvent the effluent pooling (ADWR) (see 57 FR 48389, Oct. 23, amend their water service subcontracts provision and directly exchange their 1992). In part, the City of Phoenix stated to remove the mandatory effluent effluent with Indian tribes are subject to ‘‘* * * The City of Phoenix agrees with pooling provision and we will delete the a reduction in their entitlement to CAP the reasons for deleting the mandatory mandatory effluent pooling provision in water under their subcontracts by the substitute water provision from the other CAP municipal and industrial amount of CAP water received from the Indian CAP Contracts and believes that water service subcontracts upon request. effluent exchange. it is equally important to remove the DATES: This final decision is effective The Department indicated in the 1983 provision from CAP M&I subcontracts June 18, 2003 and amends the previous CAP Water Allocation Decision that that would penalize a subcontractor for allocation decision published by CAP M&I water allocations could be entering into a direct effluent exchange Secretary Watt on March 24, 1983 (48 made more firm by execution of feasible with an Indian Community for CAP FR 12446). non-potable effluent exchanges with water.’’ The Department acknowledged ADDRESSES: To receive a copy of the Indian tribes. The 1983 CAP Water the City of Phoenix’s concerns that the Final Environmental Assessment and Allocation Decision also implemented a provisions of the effluent exchange responses thereto, contact John pooling provision whereby all M&I article in the CAP M&I water service McGlothen, NEPA Specialist, Phoenix water service subcontractors share in subcontracts may no longer be critical to Area Office, Bureau of Reclamation, the benefits of effluent exchanges. In a the management of water supplies in P.O. Box 81169, Phoenix, Arizona time of shortage of CAP water under the central Arizona. 85069, telephone: 602–216–3866. effluent pooling provision, the (2) The mandatory effluent pooling FOR FURTHER INFORMATION CONTACT: Paul additional CAP water made available as provision removes any incentive for a Nelson, Contracts and Repayment a result of any effluent exchanges with municipality to exchange effluent with Specialist, Phoenix Area Office, Bureau Indian tribes would be shared by all an Indian tribe. The Department of Reclamation, telephone: (602) 216– M&I subcontractors, thereby reducing believes that effluent producing entities, 3878. the amount of shortage for each Indian tribes, the State of Arizona, and subcontractor. The pooling provision other local organizations should be free SUPPLEMENTARY INFORMATION: was included in the CAP M&I water to pursue local water management I. Previous Notices Related to CAP Water service subcontracts. decisions that are in the best interest of II. Background The 1983 CAP Water Allocation III. Rationale for Final Decision the local economies, and that they IV. Comments on the Proposed Modification Decision also provided that the should not be constrained in such water and Responses Department could require Indian tribes management decisions by the V. Compliance with NEPA located in close proximity to mandatory effluent pooling provision. metropolitan areas to take delivery of (3) ADWR now supports removing the I. Previous Notices Related to CAP effluent in lieu of CAP water. This mandatory effluent pooling provision Water requirement was eliminated by a from the 1983 CAP Water Allocation Previous notices related to CAP water Secretarial decision published in the Decision and the CAP M&I water service were published in the Federal Register Federal Register on October 23, 1992, so subcontracts. as 37 FR 28082, Dec. 20, 1972; 40 FR that any effluent exchanges involving (4) CAWCD, as a party to the CAP 17297, Apr. 18, 1975; 41 FR 45883, Oct. Indian tribes would occur on a M&I water service subcontracts, does 18, 1976; 45 FR 52938, Aug. 8, 1980; 45 voluntary basis. not object to deletion of the mandatory

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effluent pooling provision from the Secretary’s decision. It has been contract to remove the mandatory subcontracts. instrumental in spurring the effluent pooling provision, which is (5) The Department is aware of two Department’s investigation of the issues pending. pending effluent exchange agreements arising from the mandatory effluent V. Compliance With NEPA that require Departmental approval. The exchange provision. cities of Chandler and Mesa each have The Department has completed a (3) City of Chandler, July 3, 2002 a proposed effluent exchange agreement Final Environmental Assessment (EA) with the Gila River Indian Community Comment 1–3: ‘‘The City of Chandler, on the impact of modifying the 1983 (GRIC). The benefits resulting from the Arizona submits this letter in support of CAP Water Allocation Decision to delete proposed exchanges to the cities and the proposed modification of the the mandatory effluent pooling GRIC will not occur unless and until the Secretary of Interior’s March, 1983 provision. The Final EA resulted in a mandatory effluent provision is Record of Decision, which deletes the ‘‘Finding of No Significant Impact’’ removed from the cities’ CAP water mandatory effluent pooling provision (FONSI) to the human environment and service subcontracts. from Central Arizona Project (‘‘CAP’’) was signed August 5, 2002 by (6) The Department received four water service contracts. This provision, Reclamation’s Phoenix Area Office responses to the proposed action during and the related M&I subcontracts’ Manager, Phoenix, Arizona. the Federal Register notice public effluent exchanges restriction, prevent Final Decision comment period. Each respondent municipalities from exchanging effluent provided rationale and for CAP water held by Indian The following sentence is hereby recommendations that support the communities. The proposed deleted from the 1983 CAP Water option of modifying the Secretary’s modification encourages better water Allocation Decision (March 24, 1983, 48 Record of Decision to remove the management, and will allow for a FR 12447): ‘‘This allocation is subject to mandatory effluent pooling provision. necessary effluent exchange as part of adoption of a pooling concept whereby The Department received no objections the Gila River Indian Community water all M&I allottees share in the benefits of to this proposed action. rights settlement.’’ effluent exchanges.’’ Response 1–3: The Department IV. Comments on the Proposed acknowledges the City of Chandler’s Dated: May 14, 2003. Modification and Responses statements of support for the Secretary’s Gale A. Norton, proposed modification of the 1983 Secretary of the Interior. (1) Salt River Project, July 5, 2002 Record of Decision. It also notes that [FR Doc. 03–15280 Filed 6–17–03; 8:45 am] Comment 1–1: ‘‘SRP agrees with the Chandler’s position supports and is BILLING CODE 4310–MN–P Department’s determination that the consistent with its formal request for an mandatory effluent pooling provision is amendment of its CAP water service an impediment to effluent exchanges contract to remove the mandatory DEPARTMENT OF THE INTERIOR and effective water management in effluent pooling provision, which is central Arizona. For example, without pending. Bureau of Land Management the modification the cities of Chandler and Mesa will not be able to undertake (4) City of Mesa, June 17, 2002 [MT–020–1010–AC] effluent-CAP water exchanges pursuant Comment 1–4: ‘‘The City of Mesa fully to the Reclaimed Water Exchange supports the Department’s proposal to Notice of Public Meeting, Eastern Agreement portion of the Gila River modify the 1983 Central Arizona Project Montana Resource Advisory Council Indian Community Settlement.’’ (CAP) Water Allocation Decision to Meeting Response 1–1: SRP’s expression of delete the mandatory effluent pooling AGENCY: Bureau of Land Management, support for the Department’s proposal is provision. We agree with Department’s Interior, Montana, Billings and Miles noted. determination that the mandatory effluent pooling provision is an City field offices. (2) City of Phoenix, July 5, 2002 impediment to effluent exchanges and ACTION: Notice of public meeting. Comment 1–2: ‘‘The City of Phoenix effective water management in central SUMMARY: In accordance with the has long supported the removal of that Arizona.*** The City of Mesa Federal Land Policy and Management sentence. In 1982 the City sent two intends to enter into an effluent Act (FLPMA) and the Federal Advisory letters to then Secretary of the Interior exchange agreement with the Gila River Committee Act of 1972 (FACA), the U.S. James Watt asking that the mandatory Indian Community (GRIC) through the Department of the Interior, Bureau of effluent exchange pooling concept be proposed GRIC water rights settlement. Land Management (BLM) Eastern eliminated from the Secretary’s The benefits resulting from the Montana Resource Advisory Council proposed allocation decision. We proposed exchanges to Mesa and GRIC (RAC), will meet as indicated below. maintained then that the inclusion of will not occur unless and until the such a provision would serve to inhibit mandatory effluent provision is DATES: The meeting will be held August future exchanges which would removed from Mesa’s CAP water service 14, 2003, in Billings, MT beginning at 8 otherwise be mutually beneficial to the subcontracts*** We urge the a.m. When determined, the meeting exchanging parties * * *. We are Secretary to amend Mesa’s CAP water place will be announced in a News pleased that you are now proposing to service subcontracts to delete the Release. The public comment period eliminate the mandatory effluent mandatory effluent pooling provision.’’ will begin at approximately 11 a.m. and exchange pooling requirement from Response 1–4: The Department the meeting will adjourn at both the Secretary’s record of decision acknowledges and accepts the City of approximately 3:30 p.m. and also from the CAP M&I Mesa’s statements of support for the FOR FURTHER INFORMATION CONTACT: subcontracts.’’ Secretary’s proposed modification of the Mark Jacobsen, Public Affairs Specialist, Response 1–2: The City of Phoenix 1983 Record of Decision. Its comments Miles City Field Office, 111 Garryowen position has remained consistent are consistent with its formal request for Road, Miles City, Montana, 59301, throughout the period following the an amendment of its CAP water service telephone (406) 233–2831.

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SUPPLEMENTARY INFORMATION: The 15- locations will be within the Medford At the formal meeting, the Resource member Council advises the Secretary BLM District. Advisory Committee will discuss the of the Interior, through the Bureau of The primary office meeting of the projects which were submitted for Land Management, on a variety of Resource Advisory Committee will be funding in Fiscal Year 2004. The public planning and management issues held on August 11, 2003 at the BLM will be able to comment on those associated with public land office at 3040 Biddle Road, Medford, projects at that time. The Resource management in Montana. At this Oregon beginning at 10 a.m. The Advisory Committee will make meeting, topics we plan to discuss objective of this meeting is to review recommendations on project funding to include: Sustaining Working proposals for projects to be funded in the Designated Federal Official, who is Landscapes Initiative, OHV Update, Fiscal Year 2004. If there is not enough the Medford BLM District Manager. The National RAC meeting report, time to adequately consider all the Designated Federal Official will then Weatherman Draw Subcommittee proposed projects, a follow-up meeting make a final determination on which update, Oil and Gas EIS Update and will be held at the BLM office on August projects will be funded in Fiscal Year other topics the council may raise. 14, 2003, also beginning at 10 a.m. 2004. All meetings are open to the public. The purposes of the field trips and the DATES: The field trips will take place on The public may present written meetings are to allow the Resource July 14 and July 28. They will leave the comments to the Council. Each formal Advisory Committee to discuss and BLM office at 8:30 and return at Council meeting will also have time fully understand the projects. They will approximately 4 p.m. The meeting will allocated for hearing public comments. have the opportunity to ask questions of take place at the BLM building on Depending on the number of persons BLM managers and staff as well as the August 11, 2003 beginning at 10 a.m.; a wishing to comment and time available, public parties who made the follow-up meeting will take place at the the time for individual oral comments submissions. Considering the proposals BLM office on August 14, 2003, if may be limited. Individuals who plan to in a meeting format will allow the necessary to review all the proposals attend and need special assistance, such Committee to exchange information and and make recommendations. These as sign language interpretation, tour alternatives and reach a set of times and dates will be published on the transportation or other reasonable recommendations for funding. Medford District Web site http:// accommodations, should contact the www.or.blm.gov/Medford and in the Authority: Federal Land Policy and BLM as provided above. ‘‘Medford Mail Tribune’’ and ‘‘Grant’s Management Act (FLPMA) and Secure Rural Dated: June 6, 2003. Pass Courier’’ newspapers. Schools and Community Self-Determination Act of 2000. David McIlnay, FOR FURTHER INFORMATION AND Dated: June 10, 2003. Field Manager. ADDRESSES: Comments and questions Mary L. Smelcer, [FR Doc. 03–15331 Filed 6–17–03; 8:45 am] should be sent to Roger Schnoes, Bureau BILLING CODE 4310–$$–P of Land Management, 3040 Biddle Road, Acting District Manager, Medford District, Bureau of Land Management. Medford, Oregon, 97504, (541) 618– 2417, or fax to (541) 618–2400, or e-mail [FR Doc. 03–15332 Filed 6–17–03; 8:45 am] DEPARTMENT OF THE INTERIOR to [email protected]. BILLING CODE 4310–33–P Bureau of Land Management SUPPLEMENTARY INFORMATION: The Secure Rural Schools and Community DEPARTMENT OF THE INTERIOR [OR113–5882–PF, HAG03–0197] Self-Determination Act of 2000 (Pub. L. Bureau of Land Management Notice of Resource Advisory 106–393) established the Resource Advisory Committees associated with Committee Field Trips and Meetings [WY–957–02–1420–BJ] the BLM Districts and National Forests AGENCY: Medford District, Bureau of in western Oregon to assist the BLM and Plats of Survey Filing; Wyoming Land Management, Interior. Forest Service fund projects to restore AGENCY: Bureau of Land Management, ACTION: Notice of Resource Advisory stability and predictability to the annual Interior. Committee field trips and meetings. payments to the States and counties and to benefit public schools, roads and ACTION: Notice of filing of plats of SUMMARY: The Medford District BLM other purposes. The Medford BLM survey, Wyoming. will be hosting a series of field trips and Resource Advisory Committee has met meetings for the Medford Resource in 2001 and 2002 and made SUMMARY: The Bureau of Land Advisory Committee. The purpose of recommendations for funding projects. Management (BLM) has filed the plats of the field trips and meetings will be to Projects for Fiscal Year 2004 have been survey of the lands described below in discuss and make recommendations for submitted by BLM staff and by the the BLM Wyoming State Office, projects submitted for funding under the public and these have been made Cheyenne, Wyoming, on June 9, 2003. Secure Rural Schools and Community available to the Resource Advisory FOR FURTHER INFORMATION CONTACT: Self-Determination Act of 2000 (Pub. L. Committee. They will also be published Bureau of Land Management, 5353 106–393). The committee will also be on the BLM Web site at http:// Yellowstone Road, PO Box 1828, reviewing the progress of projects www.or.blm.gov/Medford. The Resource Cheyenne, Wyoming 82003. funded in previous years. Advisory Committee will have two SUPPLEMENTARY INFORMATION: These The field trips will leave from the opportunities to visit project sites surveys were executed at the request of BLM office at 3040 Biddle Road, during the field trips in July which are the Bureau of Land Management, and Medford, Oregon at 8:30 a.m. and will the subject of this notice. The field trips are necessary for the management of return to the BLM office at will include some of the projects being resources. The lands surveyed are: approximately 4 p.m. on July 14, 2003 proposed for Fiscal Year 2004 as well as The plat representing the dependent and July 28, 2003. The itinerary of the some of the projects already approved resurvey of a portion of the field trips will vary depending on the and funded in Fiscal Years 2002 and subdivisional lines, and the subdivision types of projects to be visited, but all 2003. of section 28, and the metes and bounds

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survey of Parcel A, section 28 Township DEPARTMENT OF THE INTERIOR making process, findings on impairment 26 north, Range 105 west, Sixth of park resources and values, a Principal Meridian, Wyoming, was National Park Service description of the environmentally accepted June 9, 2003. preferred alternative, and a listing of The plat representing the dependent Jamestown Project Development measures to minimize and/or mitigate resurvey of a portion of the Concept Plan, Final Environmental environmental harm. It also includes the subdivisional lines and the subdivision Impact Statement, Colonial National Programmatic Agreement between and of section lines and the subdivision of Historical Park, Jamestown Unit, the NPS, the Advisory Council on section 27, Township 34 north, Range Jamestown, Virginia, and Jamestown Historic Preservation, and the Virginia 109 west, Sixth Principal Meridian, National Historic Site, Jamestown, State Historic Preservation Office for Wyoming, was accepted June 9, 2003. Virginia Implementation of the Jamestown Copies of the preceding described AGENCY: National Park Service, Project Development Concept Plan; the plats are available to the public. Department of the Interior. Statement of Findings on Floodplains and Wetlands; and the U.S. Fish and Dated: June 12, 2003. ACTION: Notice of availability of a record Wildlife Service Biological Opinion. John P. Lee, of decision on the final environmental FOR FURTHER INFORMATION CONTACT: impact statement for the Jamestown Chief Cadastral Surveyor, Division of Support Mike Litterst, Information Officer, Services. Project Development Concept Plan, Colonial National Historical Park, (757) Colonial National Historical Park, [FR Doc. 03–15328 Filed 6–17–03; 8:45 am] 898–2409, [email protected]. BILLING CODE 4310–22–P Jamestown Unit, and Jamestown National Historic Site. SUPPLEMENTARY INFORMATION: Copies of the Record of Decision may be obtained DEPARTMENT OF THE INTERIOR SUMMARY: Pursuant to § 102(2)(C) of the from the contact listed above or online National Environmental Policy Act of at http://www.nps.gov/colo. Bureau of Land Management 1969 Pub. L. 91–190, 83 Stat. 852, 853, Dated: May 13, 2003. codified as amended at 42 U.S.C. Marie Rust, [WY–957–02–1910–BJ] 4332(2)(C), the National Park Service Regional Director, Northeast Region, National announces the availability of the Record Park Service. Plats of Survey; Wyoming of Decision for the Jamestown Project [FR Doc. 03–15306 Filed 6–17–03; 8:45 am] Development Concept Plan, BILLING CODE 4310–78–M AGENCY: Bureau of Land Management, Environmental Impact Statement, Interior. Colonial National Historical Park, ACTION: Notice of filing of plats of Jamestown Unit, Jamestown, Virginia, DEPARTMENT OF THE INTERIOR survey, Wyoming. and Jamestown National Historic Site, Jamestown, Virginia. ON May 13, 2003, National Park Service SUMMARY: The Bureau of Land the Director, Northeast Region, Management (BLM) is scheduled to file approved the Record of Decision for the Chesapeake and Ohio Canal National the plat of survey of the lands described project. As soon as practicable, the Historic Park Advisory Commission; below, thirty (30) calender days from National Park Service will begin to Notice of Public Meeting the date of this publication in the BLM implement the Preferred Alternative Notice is hereby given in accordance Wyoming State Office, Cheyenne, contained in the Final Environmental Wyoming. with the Federal Advisory Committee Impact Statement issued on April 2, Act that a meeting of the Chesapeake FOR FURTHER INFORMATION CONTACT: 2003. The Preferred Alternative and Ohio Canal National Historic Park Bureau of Land Management, 5353 includes strategies for an updated Advisory Commission will be held at 10 Yellowstone Road, PO Box 1828, interpretive experience; the a.m. on Friday, June 20, 2003, at park Cheyenne, Wyoming 82003. improvement or repalcement of headquarters, 1850 Dual Highway, Suite SUPPLEMENTARY INFORMATION: These facilities (including the current Visitor 100, Hagerstown, Maryland. surveys were executed at the request of Center, collections storage, and The Commission was established by the Bureau of Indian Affairs and are parking); the addition of comfort/ Public Law 91–664 to meet and consult necessary for the managements of hospitality services and new with the Secretary of the Interior on resources. The lands surveyed are: interpretive venues; and enhanced and general policies and specific matters The plat representing the dependent multimodal transportation options related to the administration and resurvey of portion of the First Guide (including water taxis/tours/ hike/bike development of the Chesapeake and Merdian west, through Township 5 N, trails, and shuttle services). This course Ohio Canal National Historical Park. between Ranges 4 and 5 west, and a of action and 4 alternatives were The members of the Commission are portion of the subdivisional lines, and analyzed in the Draft and Final as follows: Mrs. Sheila Rabb the subdivision of section 24, Township Environmental Impact Statements. The Weidenfeld, Chairman, Mr. Charles J. 5 North, Range 5 west, Wind River full range of foreseeable environmental Weir, Mr. Barry A. Passett, Mr. Terry W. Meridian, Wyoming, was accepted June consequences was assessed, and Hepburn, Ms. Elise B. Heinz, Ms. JoAnn 9, 2003. appropriate mitigating measures were M. Spevacek, Mrs. Mary E. Woodward, Copies of the preceding described plat identified. Mrs. Donna Printz, Mrs. Ferial S. is available to the public. The Record of Decision includes a Bishop, Ms. Nancy C. Long, Mrs. Jo statement of the decision made, a Reynolds, Dr. James H. Gilford, Mrs. Sue Dated: June 12, 2003. description of the project background, a Ann Sullivan, Brother James John P. Lee, detailed description of the alternative to Kirkpatrick. Chief Cadastral Surveyor, Division of Support be implemented, the basis for the Topics that will be presented during Services. decision, synopses of other alternatives the meeting include: [FR Doc. 03–15329 Filed 6–17–03; 8:45 am] considered, an overview of public and 1. Status of the draft Lands Protection BILLING CODE 4310–22–P agency involvement in the decision- Plan.

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2. Major construction/development Colorado Richardson—Bower Building, (Sugar House Business District MPS), 1019 East 2100 projects. Boulder County 3. Historic Leasing program. South, Salt Lake City, 03000636 4. Mecklenburg warehouse planning Jamestown Town Hall, 118 Main St., Sprague Branch of the Salt Lake City Public Jamestown, 03000615 project. Library, (Sugar House Business District 5. Western Maryland Railroad right- Louisiana MPS), 2131 S. Highland Dr., Salt Lake City, 03000637 of-way planning study. East Baton Rouge Parish 6. Business Plan. Sugar House LDS Ward Building, (Sugar The meeting will be open to the Broussard House, 4512 Highland Rd., Baton House Business District MPS), 1950 South Rouge, 03000616 public. Any member of the public may 1200 East, Salt Lake City, 03000631 file with the Commission a written Maine Sugar House Monument, (Sugar House Business District MPS), 1100 East and 2100 statement concerning the matters to be Cumberland County discussed. Persons wishing further South, Salt Lake City, 03000638 Freeman Farm Historic District, 342 W. Gray information concerning this meeting, or Utah State Liquor Agency #22, (Sugar House Rd., Gray, 03000621 Business District MPS), 1938 South 1100 who wish to submit written statements, East, Salt Lake City, 03000639 may contact Douglas D. Faris, Knox County Superintendent, C&O Canal National Beechnut Hut Historic District, 316 Beech Sanpete County Historic Park, 1850 Dual Highway, Suite Hill Rd., Rockport, 03000617 Mortensen—Nelson House, 291 East 100 100, Hagerstown, Maryland, 21740. Lincoln County South, Moroni, 03000632 Minutes of the meeting will be Arch Bridge, Over the Pemaquid R on Benner Virginia available for public inspection six (6) Rd., Bristol, 03000618 weeks after the meeting at park Arlington County Oxford County headquarters, Hagerstown, Maryland. Al’s Motors, 3910 Wilson Blvd., Arlington, Bell Hill Meetinghouse, 191 Bell Hill Rd., Dated: May 5, 2003. 03000628 Otisfield, 03000620 Douglas Faris, Bell Hill School, 185 Bell Hill Rd., Otisfield, [FR Doc. 03–15309 Filed 6–17–03; 8:45 am] Superintendent, C&O Canal National 03000619 BILLING CODE 4312–51–P Historical Park. Michigan [FR Doc. 03–15307 Filed 6–17–03; 8:45 am] BILLING CODE 4310–6V–M Alpena County DEPARTMENT OF THE INTERIOR Fishing Tug Katherine V, 491 Johnson St., Alpena, 03000622 National Park Service DEPARTMENT OF THE INTERIOR Benzie County National Register of Historic Places; National Park Service Watervaile Historic District, 975–1422 Notification of Pending Nominations Watervale Rd., Blaine Township, 03000624 National Register of Historic Places; Houghton County Nominations for the following Notification of Pending Nominations Vivian, Jr., J., and Company Building, 342 properties being considered for listing Nominations for the following Hecla St., Laurium, 03000625 in the National Register were received by the National Park Service before May properties being considered for listing Leelanau County in the National Register were received 24, 2003. Pursuant to section 60.13 of 36 Fountain Point, 990 South Lake Leelanau Dr., CFR part 60 written comments by the National Park Service before May Suttoms Bay Township, 03000623 31, 2003. Pursuant to § 60.13 of 36 CFR concerning the significance of these part 60 written comments concerning Texas properties under the National Register the significance of these properties Bexar County criteria for evaluation may be forwarded by United States Postal Service, to the under the National Register criteria for Bungalow Colony Historic District, Roughly evaluation may be forwarded by United bounded by Duncan Dr., Crockett Dr., National Register of Historic Places, States Postal Service, to the National Walker Rd. and Robins Dr., San Antonio, National Park Service, 1849 C St. NW., Register of Historic Places, National 03000627 2280, Washington, DC 20240; by all Park Service, 1849 C St. NW., 2280, Kelly Field Historic District, Roughly other carriers, National Register of Washington, DC 20240; by all other encompassing the 1600 abd 1700 Areas of Historic Places, National Park Service, carriers, National Register of Historic Kelly AFB, San Antonio, 03000626 1201 Eye St. NW., 8th floor, Washington Places, National Park Service,1201 Eye Utah DC 20005; or by fax, (202) 371–6447. Written or faxed comments should be St. NW., 8th floor, Washington DC Salt Lake County 20005; or by fax, 202–371–6447. Written submitted by July 3, 2003. Crown Cleaning and Dyeing Company or faxed comments should be submitted Building, (Sugar House Business District Carol D. Shull, by July 3, 2003. MPS), 1989 South 1100 East, Salt Lake Keeper of the National Register of Historic Carol D. Shull, City, 03000633 Places. Granite LDS Stake Tabernacle, (Sugar House Keeper of the National Register of Historic Business District MPS), 2005 South 900 AMERICAN SAMOA Places. East, Salt Lake City, 03000630 California Granite Lumber Company Building, (Sugar Eastern District House Business District MPS), 1090 East Thompson, Sadie, Building, along main road, Sacramento County 2100 South, Salt Lake City, 03000629 Malaloa, 03000582. Ehrhardt, William, House, Dartmoor Way and Petty Motor Company Annex, (Sugar House Percheron Dr., Elk Grove, 03000614 Business District MPS), 2030 South 900 CALIFORNIA East, Salt Lake City, 03000634 Madera County Yolo County Redman Van and Storage Company Building, Union Church of Dunnigan, 3615 Cty Rd. (Sugar House Business District MPS), 1240 Gerry Building, 910 S. Los Angeles St., Los 89A, Dunnigan, 03000613 East 2100 South, Salt Lake City, 03000635 Angeles, 03000583.

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DISTRICT OF COLUMBIA Rockland County DEPARTMENT OF THE INTERIOR District of Columbia Perry, Jacob P., House, 15 Sickeletown Rd., Pearl River, 03000594. National Park Service Capitol Hill Historic District (Boundary Increase), Roughly bounded by 7th St. NE, Saratoga County Notice of Realty Action Proposed I–295, M St. SE and 11th St. SE, First United Methodist Church, 36 Second Exchange of Interests in Federally- Washington, 03000585. St., Lion, 03000601. Owned Land for Privately-Owned Connecticut Avenue Bridge, Connecticut Lands Located in Montgomery County, Ave., NW., of Rock Creek, Washington, Steuben County State of Maryland 03000584. Wombough, William, House, 145 E. Front St., GEORGIA Addison, 03000593. AGENCY: National Park Service, Interior. ACTION: Notice of realty action for Jeff Davis County Tioga County proposed land exchange. Pace House, 61 E. Coffee St., Hazlehurst, Waverly Village Hall, 358–360 Broad St., 03000591. Waverly, 03000600. SUMMARY: The following described interests in federally-owned land which IDAHO Ulster County was acquired by the National Park Lincoln County Childs, Walstein, House, Sand Hill Rd., Service has been determined to be Wood River Center Grange No. 87, 375 W 4 Wallkill Correctional Facility, Wallkill, suitable for disposal by exchange. The Mile Rd., Shoshone, 03000586. 03000602. authority for this exchange is section 3 Forsyth, James and Mary, House, 31 Albany of Public Law 91–664 (84 Stat. 1978), MISSISSIPPI Ave., Kingston, 03000603. which authorized the donation, Bolivar County Westchester County purchase with donated or appropriated Downtown Cleveland Historic District funds, or exchange of land and interests St. Peter’s Episcopal Church, 137 N. Division (Boundary Increase), 201 S. Court St. and therein on the Chesapeake and Ohio 200–215 N. Pearman Ave., Cleveland, St., Peekskill, 03000598. Canal National Historical Park, and 03000588. NORTH CAROLINA section 5 of Public Law 90–401 (82 Stat. Coahoma County 356), which also authorizes land Dare County exchanges. Clark, John, House, 211 Clark St., Clarksdale, Bodie Island Light Station, Off NC 12, Nags DATES: Comments on this proposed land 03000589. Head, 03000607. exchange will be accepted through Lauderdale County OHIO August 4, 2003. Terminal Building, Old, Hangar and Summit County ADDRESSES: Detailed information Powerhouse at Key Field, 2525 U.S. 11 S, concerning this exchange including Meridian, 03000587. Lutz—Martin Farm, 2470 Martin Rd., Bath, precise legal descriptions, Land NEW YORK 03000608. Protection Plan, environmental and Allegany County SOUTH DAKOTA cultural analysis and reports are available at the National Trails Land Lake County Belmont Literary and Historical Society Free Resources Program Center, 1314 Edwin Library, 2 Willets Ave., Belmont, Lake Badus Rural Agricultural Historic Miller Boulevard, PO Box 908, 03000599. District, Roughly bounded by US 81, Cty Martinsburg, West Virginia 25402. Bolivar Free Library, 390 Main St., Bolivar, Rte. 16, Cty Rte. 37, and Cty Rte 20, Nunda, 03000606. Comments may also be mailed to this 03000609. address. Cattaraugus County TEXAS FOR FURTHER INFORMATION CONTACT: Judy Bedford Corners Historic District, NY 305 at Gonzales County L. Brumback, Chief, Acquisition Deer Creek and Dodge Creek Rds., Division, National Park Service, Portville, 03000590. Spooner, Thomas Harrison and Mollie, National Trails Resources Program Bryant Hill Cemetery, Bryant Hill Rd. near House, 207 St. Francis St., Gonzales, Crane Rd., Ellicottville, 03000605. Center, PO Box 908, Martinsburg, WV 03000610. 25402–0908. Phone (304) 263–4943. Columbia County The following resource is being REMOVED SUPPLEMENTARY INFORMATION: The Clermont Civic Historic District, (Clermont for procedural error: selected interest in federal land is MRA) 1795 US 9, Clermont, 03000604. NORTH CAROLINA located within the boundaries of the Chesapeake and Ohio Canal National Erie County Pitt County Historical Park and is not required for Reformed Mennonite Church, Former, 5178 Greenville Commercial Historic District, Main St., Williamsville, 03000596. inclusion into the park unit area. The Roughly bounded by West Third, South land has been surveyed for cultural Nassau County Evans and East and West Fifth St.s, resources and endangered and Underhill, George, House, 28 Factory Pond Greenville 03000419. threatened species. These reports are Rd., Locust Valley, 03000592. A request for a MOVE has been made for available upon request. the following resource: Onondaga County The United States of America will LOUISIANA acquire a 16.10-acre parcel of land Fuller, James and Lydia Canning, House, currently owned by Jacob R. Ramsburg, (Freedom Trail, Abolitionism, and African St. John the Baptist Parish Jr., et al., lying within the boundaries of American Life in Central New York MPS) W. Genesee St., Skaneateles, 03000595. Graugnard House, 2294 LA 44, Reserve the Chesapeake and Ohio Canal vicinity, 94001249. National Historical Park. Three cabins Rensselaer County are located on the tract. Acquisition of [FR Doc. 03–15310 Filed 6–17–03; 8:45 am] Sherman Farm, 35 Sherman Rd., Pittstown, this land will allow the Park to 03000597. BILLING CODE 4312–51–P consolidate its inholdings and provide

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for visitor access by foot to the Potomac action to modify or vacate, this realty of this publication in the Federal River and Canal. The land is being action will become the final Register. acquired in fee simple subject to a determination of the Department of the The OMB is particularly interested in reservation of a 17-year term estate for Interior. comments which: • use and occupancy of structures located Dated: February 25, 2003. Evaluate whether the proposed on the land. Kevin Brandt, collection of information is necessary In exchange for the land described in for the proper performance of the Acting Superintendent, Chesapeake and Ohio the previous paragraph, the United Canal National Historical Park. functions of the agency, including States will convey a term estate, for whether the information will have [FR Doc. 03–15308 Filed 6–17–03; 8:45 am] seventeen years, for use and occupancy practical utility; of structures located on the following BILLING CODE 4310–6V–M • Evaluate the accuracy of the federally-owned property: Tract 17–116 agency’s estimate of the burden of the is an interest in a 21.38-acre tract proposed collection of information, acquired in fee (formerly Tract 17–101) DEPARTMENT OF LABOR including the validity of the by the United States of America by deed methodology and assumptions used; Office of the Secretary recorded in Book 4598, Page 621, in the • Enhance the quality, utility, and Land Records of Montgomery County, Submission for OMB Review; clarity of the information to be State of Maryland. Twenty-two cabins Comment Request collected; and are located on the tract. Conveyance of • Minimize the burden of the the interests in land by the United June 5, 2003. collection of information on those who States of America will be done by The Department of Labor (DOL) has are to respond, including through the Quitclaim Deed. submitted the following public use of appropriate automated, The land to be acquired by the United information collection request (ICR) to electronic, mechanical, or other States of America is described as the Office of Management and Budget technological collection techniques or follows: Tract 17–100 is a 16.10-acre (OMB) for review and approval in other forms of information technology, tract acquired by Jacob R. Ramsburg, Jr., accordance with the Paperwork e.g., permitting electronic submission of et al., and recorded in Book 5322, Page Reduction Act of 1995 (Pub. L. 104–13, responses. 501, in Land Records of Montgomery 44 U.S.C. Chapter 35). A copy of this Agency: Employment Standards County, State of Maryland. Conveyance ICR, with applicable supporting Administration (ESA). of the fee simple title will be done by documentation, may be obtained by Type of Review: Extension of a a Special Warranty Deed as approved by calling the Department of Labor. To currently approved collection. the Solicitor’s Office. obtain documentation, contact Darrin Title: 29 CFR Part 825, The Family The value of the interests and land to King on 202–693–4129 (this is not a toll- and Medical Leave Act of 1993. be exchanged has been determined by a free number) or E-Mail: OMB Number: 1215–0181. current fair market value appraisal and [email protected]. Frequency: On occasion. the value of land and/or interests to be Comments should be sent to Office of Type of Response: Recordkeeping and conveyed is equal. Information and Regulatory Affairs, third party disclosure. Interested parties may submit written Attn: OMB Desk Officer for the Affected Public: Individuals or comments to the address listed in the Employment Standards Administration, households; business or other for-profit; ADDRESSES paragraph. Adverse Office of Management and Budget, Not-for-profit institutions; farms; comments will be evaluated and this Room 10235, Washington, DC 20503 Federal Government; and State, Local, action may be modified or vacated (202–395–7316 / this is not a toll-free or Tribal Government. accordingly. In the absence of any number), within 30 days from the date Number of Respondents: 6,655,000.

Annual Average re- Annual burden Information collection requirement responses sponse time hours

Employee Notice of Need for FMLA Leave ...... 4,150,000 0.02 69,167 Notice to Employees of FMLA Rights— WH–381: Providing Guidance 388,000 0.17 64,667 Providing Written Notice to Employees ...... 4,150,000 0.08 345,833 Medical Certifications and Recertifications (Serious Health Condition)—WH–380: Medical Certifications—Initial ...... 1,660,000 0.33 553,333 Medical Certifications—Additional ...... 166,000 0.33 55,333 Medical Recertifications ...... 83,000 0.33 27,667 Fitness-for-Duty Medical Certifications ...... 207,500 0.17 34,583 Notice to Employees of Change 12-Month Period for Determining FMLA Entitlement ...... 38,800 0.17 6,467 Key Employee Notification: First Notice ...... 41,500 0.08 3,458 Second Notice ...... 20,750 0.08 1,729 Recordkeeping ...... 4,150,000 0.05 207,500

Total ...... 15,055,550 ...... 1,369,737

Total Annualized capital/startup Description: The Family and Medical of 50 or more employees, and public costs: $0. Leave Act of 1993 (FMLA), Public Law agencies to provide up to 13 weeks of Total annual costs (operating/ 103–3, 107 Stat. 6, 29 U.S.C. 2601, unpaid, job-protected leave during any maintaining systems or purchasing which became effective on August 5, 12-month period to eligible employees services): $0. 1993, requires private sector employers for certain family and medical reasons.

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This ICR contains recordkeeping and DEPARTMENT OF LABOR for the proper performance of the notification requirements associated functions of the agency, including with the Act and implementing Office of the Secretary whether the information will have regulations found at 29 CFR Part 825. practical utility; Submission for OMB Review; Two optional forms are included in this • Evaluate the accuracy of the Comment Request information collection request. The agency’s estimate of the burden of the WH–380, Certification of Health Care June 11, 2003. proposed collection of information, Provider, may be used to certify a The Department of Labor (DOL) has including the validity of the serious health condition under FMLA. submitted the following public methodology and assumptions used; The WH–381, Employer Response to information collection requests (ICR’s) • Enhance the quality, utility, and Employee Request for Family or to the Office of Management and Budget clarity of the information to be Medical Leave may be used by an (OMB) for review and approval in collected; and minimize the burden of employer to respond to a leave request accordance with the Paperwork the collection of information on those under FMLA. Both forms are third-party Reduction Act of 1995 (Pub. L. 104–13, who are to respond, including through notifications and are sent to the 44 U.S.C. Chapter 35). A copy of the the use of appropriate automated, employee; they are not submitted to the ICR’s, with applicable supporting electronic, mechanical, or other Department of Labor. This information documentation, may be obtained by technological collection techniques or collection is currently approved for use calling the Department of Labor. To other forms of information technology, through July 31, 2003. obtain documentation, contact Vanessa e.g., permitting electronic submission of Reeves on 202–693–4121 (this is not a responses. The Department of Labor seeks OMB toll-free number) or E-Mail: Agency: Employee Benefits Security approval for the extension of this [email protected]. Administration (EBSA). information collection in order to Comments should be sent to Office of ensure that both employers and Type of Review: Extension of a Information and Regulatory Affairs, currently approved collection. employees are aware of and can exercise Attn: OMB Desk Officer for the their rights and meet their respective Title: Prohibited Transaction Class Employee Benefits Security Agency, Exemptions for Multiple Employer & obligations under FMLA, and in order Office of Management and Budget, for the Department of Labor to carry out Multiple Employer Apprenticeship Room 10235, Washington, DC 20503 Plans, PTCE 76–1, PTCE 77–10, PTCE its statutory obligation under FMLA to (202–395–7316/this is not a toll-free investigate and ensure employer 78–6. number), within 30 days from the date OMB Number: 1210–0058. compliance have been met. of this publication in the Federal Affected Public: Business or other for- Ira L. Mills, Register. The OMB is particularly interested in profit and individuals or households. Departmental Clearance Officer. comments which: Frequency: On occasion. [FR Doc. 03–15342 Filed 6–17–03; 8:45 am] • Evaluate whether the proposed Type of Response: Recordkeeping. BILLING CODE 4510–27–P collection of information is necessary Number of Respondents: 4,810.

Average Information collection requirements Annual response time Annual burden responses (hours) hours

PTCE 76–1, Part A ...... 0 0.00 0 PTCE 76–1, Part B ...... 58 0.25 15 PTCE 76–1, Part C ...... 4,623 0.25 1,156 PTCE 77–10 ...... 0 0.00 0 PTCE 78–6 ...... 645 0.08 54

Total ...... 5,326 ...... 1,225

Total Annualized Capital/Startup construction loans involving plans and OMB No. 1210–0080, by incorporating Costs: $0. participating employers must be in the information collection provisions of Total Annual Costs (operating/ writing, and records must be maintained PTCE 78–6 into the revision ICR number maintaining systems or purchasing for six years. Part C permits plans to OMB No. 1210–0058 and allowing the services): $0. lease office space and provide control number for PTCE 78–6 to expire. Description: Prohibited Transaction administrative services or sell goods to PTCE 78–6 provides an exemption to Class Exemption 76–1, approved under a participating employer, employee multiple employer apprenticeship plans OMB No. 1210–0058, provides an organization, participating employer for the purchase of personal property or exemption, under specified conditions, association or to another multiple the lease of real property by a plan to from certain of ERISA’s prohibited employer plan that is a party in interest. a contributing employer. The transaction provisions at section 406(a) A related exemption, PTCE 77–10, also Department believes that the public will for various transactions involving multi- approved under OMB No. 1210–0058, benefit by having the opportunity to employer or multi employer plans complements Part C of PTCE 76–1 by comment on the three information (together, multiple employer plans). Part providing an exemption from sections collection provisions at the same time A of PTCE 76–1 provides that an 406(a) and 407(a) of ERISA. because the three exemptions are agreement between a plan and an The Department proposes to combine closely related in that they provide employer for extending the time for a the information collection under PTCE relief from prohibited transactions for contribution must be in writing. Part B 76–1 with the information collection in multiple employer plans or multiple provides that permanent financing for PTCE 78–6, currently approved under employer apprenticeship plans and they

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have the same recordkeeping Total Annual Costs (operating/ DEPARTMENT OF LABOR provisions. maintaining systems or purchasing Agency: Employee Benefits Security services): $0. Office of the Secretary Administration (EBSA). Description: Prohibited Transaction Women’s Bureau; Women in Type of Review: Extension of a Class Exemption 90–1 provides an Apprenticeship and Nontraditional currently approved collection. exemption from certain provisions of Occupations (WANTO) Act of 1992 FY– Title: Bank Collective Investment the Employee Retirement Income 2003 Budget, Training and Funds; Prohibited Transaction Class Security Act of 1974 (ERISA) for certain Employment Services (TES) 1630174 Exemption 91–38. transactions involving insurance OMB Number: 1210–0082. company pooled separate accounts in AGENCY: Women’s Bureau, Department Affected Public: Business or other for- which employee benefit plans of Labor. profit; individuals or households; and participate and which are otherwise ACTION: Notice of Availability of Funds not-for-profit institutions. prohibited by ERISA. Specifically, the and Solicitation For Grant Applications Frequency: On occasion. exemption allows persons who are (SGA 03–12). Type of Response: Recordkeeping. parties in interest to a plan that invests Number of Respondents: 1,036. in a pooled separate account, such as a This notice contains all of the Number of Annual Responses: 1,036. service provider, to engage in information needed to apply for grant Estimated Time Per Responses: 5 transactions with the separate account if funding. Grant proposals that are not minutes. the plan’s participation in the separate completed as directed will be judged Total Burden Hours: 86. account does not exceed specified non-responsive and will not be Total Annualized Capital/Startup limits. This ICR covers the evaluated. Costs: $0. recordkeeping requirements for SUMMARY: The Women’s Bureau, U.S. Total Annual Costs (operating/ insurance companies. Department of Labor (DOL), announces maintaining systems or purchasing Agency: Employee Benefits Security the 2003 Solicitation for Grant services): $0. Administration (EBSA). Applications (SGA) authorized under Description: Prohibited Transaction Type of Review: Extension of a the Women in Apprenticeship and Class Exemption 91–38 provides an currently approved collection. Nontraditional Occupations (WANTO) exemption from the prohibited Title: Foreign Exchange Transactions; Act of 1992. The purpose of this transaction provisions of ERISA for Prohibited Transaction Class Exemption program is to assist employers and labor certain transactions between a bank 94–20. unions in the placement and retention collective investment fund and persons of women in apprenticeship and who are parties in interest with respect OMB Number: 1210–0085. nontraditional occupations. To that end, to a plan provided that the plan’s Affected Public: Business or other-for WANTO grant funds are disbursed to participation in the collective profit; individuals or households; and eligible community-based organizations, investment fund does not exceed a not-for-profit institutions. which may be faith-based, which, in specific percentage of the total assets in Frequency: On occasion. turn, provide employers and labor the collective investment fund. To Type of Response: Recordkeeping. unions with technical assistance geared insure that the exemption is not abused, Number of Respondents: 130. towards the successful placement and that the rights of the participants and Number of Annual Responses: 650. retention of women in apprenticeship beneficiaries are protected, and that a and nontraditional occupations. bank is complying with the conditions Estimated Time Per Responses: 5 minutes. DATES: One signed original, complete of the exemption, the Department grant application plus two copies of the Total Burden Hours: 54. requires records pertaining to the Technical Proposal and two copies of exempted transaction to be maintained Total Annualized Capital/Startup the Cost Proposal must be submitted. by the bank for six years. The Costs: $0. The original and copies must be recordkeeping requirement is the Total Annual Costs (operating/ submitted by 4:45 p.m. e.s.t., August 11, subject of this proposed extension of an maintaining systems or purchasing 2003. Hand-delivered applications must ICR. services): $0. be received by that time. An application Agency: Employee Benefits Security Description: Prohibited Transaction received after August 11, 2003, will not Administration (EBSA). Class Exemption 94–20 permits the be considered unless it is received Type of Review: Extension of a purchase and sale of foreign currencies before awards are made and: currently approved collection. between an employee benefit plan and 1. It was sent by registered or certified Title: Prohibited Transaction Class a bank or a broker-dealer or an affiliate mail not later than August 6, 2003. Exemptions 90–1; Pooled Separate thereof that is a party in interest with 2. It is determined by the government Accounts. respect to such plan. In the absence of that the late receipt was due solely to OMB Number: 1210–0083. this exemption, certain aspects of these mishandling by the government after Affected Public: Business or other-for transactions could be prohibited by receipt at the U.S. Department of Labor profit; individuals or households; and section 406(a) and 406(b) of the at the address listed under ADDRESSES; not-for-profit institutions. Employee Retirement Income Security or Frequency: On occasion. Act of 1974. This ICR covers the 3. It was sent by U.S. Postal Service Type of Response: Recordkeeping. disclosure and recordkeeping Express Mail Next Day Service—Post Number of Respondents: 128. requirements for a bank, broker-dealer, Office to Addressee, not later than 4:45 Number of Annual Responses: 128. or affiliate thereof. p.m. e.s.t. on August 9, 2003. Estimated Time Per Responses: 5 The only acceptable evidence to minutes. Ira L. Mills, establish the date of mailing of a late Total Burden Hours: 11. Departmental Clearance Officer. application sent by registered or Total Annualized Capital/Startup [FR Doc. 03–15343 Filed 6–17–03; 8:45 am] certified mail is the U.S. Postal Service Costs: $0. BILLING CODE 4510–29–M postmark on the envelope or wrapper

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and on the original receipt from the U.S. contacting Cassandra Willis, U.S. applicant’s intention to begin Postal Service. If the postmark is not Department of Labor, Procurement performance no later than October 1, legible, an application received after the Services Center; (202) 693–4570 (this is 2003. specified time and date will be not a toll-free number), prior to the D. Acronyms and Definitions. The processed as if mailed late. ‘‘Postmark’’ closing deadline. following terms are defined for the means a printed, stamped, or otherwise Application announcements or forms convenience of prospective applicants: placed impression (not a postage meter will not be mailed. The Federal Register WANTO refers to Women in machine impression) that is readily may be obtained from your nearest Apprenticeship and Nontraditional identifiable without further action as government office or library. In Occupations. having been applied and affixed by an addition, a copy of this notice and the A/NTO refers to apprenticeship and employee of the U.S. Postal Service on application requirements may be nontraditional occupations. the date of mailing. Therefore, downloaded from the Women’s E/LU refers to employers and labor applicants shall request that the postal Bureau’s Web site at http:// unions. clerk place a legible hand cancellation www.dol.gov/wb/nontra.htm. ATELS refers to the Apprenticeship bull’s-eye postmark on both the receipt All questions about this SGA should Training, Employer and Labor Services and the wrapper or envelope. be directed to Cassandra Willis, U.S. office of the Employment and Training The only acceptable evidence to Department of Labor, Procurement Administration, U.S. Department of establish the date of mailing of a late Services Center, Room N–5416, 200 Labor. application sent by U.S. Postal Service Constitution Avenue, NW., Washington, WB refers to the Women’s Bureau, Mail Next Day Service—Post Office to DC 20210; 202–693–4570. U.S. Department of Labor. Addressee is the date entered by the SUPPLEMENTARY INFORMATION: TA refers to technical assistance. post office receiving clerk on the Part I. Background NTO (Nontraditional Occupations) are ‘‘Express Mail Next Day Service-Post those where women account for less Office to Addressee’’ label and the A. Authority and Funding. The Women in Apprenticeship and than 25 percent of all persons employed postmark on the envelope or wrapper in a single occupational group. For the and on the original receipt from the U.S. Nontraditional Occupations (WANTO) Act of 1992 (29 U.S.C. 2501 et seq.) most recent listing of nontraditional Postal Service. ‘‘Postmark’’ has the same jobs, see the WB Web site at meaning as defined in the preceding authorizes the Department of Labor (DOL) to disburse technical assistance www.dol.gov/wb/stats/main.htm. paragraph. Therefore, applicants shall Pre-Apprenticeship Programs are request that the postal clerk place a grants. The WANTO grants for Fiscal Year (FY) 2003 are funded by DOL FY those programs that prepare individuals legible hand cancellation bull’s-eye for apprenticeship or entry-level postmark on both the receipt and the 2003 Budget: Training and Employment Services (TES) 1630174. The Women’s employment in NTO. Depending on the envelope or wrapper. apprenticeable or other nontraditional The only acceptable evidence to Bureau (WB) co-administers the WANTO program with the DOL Office occupation for which the program is establish the time of receipt at the U.S. preparing students, the curriculum Department of Labor is the date/time of Apprenticeship Training, Employer and Labor Services (ATELS). WB has would vary. For example, a curriculum stamp of the Office of Procurement for the construction trades may include Services on the application wrapper or responsibility for implementing the grant process. pre-vocational identification and use of other documentary evidence of receipt B. Purpose. The WANTO Act’s tools, blueprint reading, basic shop maintained by that office. Applications purpose is to provide technical skills, safety procedures, math skills, sent by other delivery services, such as assistance to employers and labor and physical conditioning. English as a Federal Express, UPS, etc., will also be unions (E/LU) to encourage employment Second Language and team-building accepted; however, the applicant bears of women in apprenticeships and skills such as effective listening and the responsibility of timely submission. nontraditional occupations (A/NTO). feedback might be included in curricula ADDRESSES: Applications must be WANTO grants are awarded to preparing students for some entry-level directed to the U.S. Department of community-based organizations (CBOs), nontraditional jobs. Labor, Procurement Services Center, which may be faith-based, to deliver Apprenticeship is a formal Attention: Cassandra Willis, Reference technical assistance to E/LU to prepare employment relationship designed to SGA 03–12, Room N–5416, 200 them to successfully recruit, train, promote skill training and learning on Constitution Avenue, NW., Washington, employ and retain women in A/NTO. the job. ‘‘Hands on’’ learning takes place DC 20210. DOL has found that placement and in conjunction with related theoretical FOR FURTHER INFORMATION CONTACT: All retention of women in A/NTO pose instruction (often in a classroom applicants are advised that U.S. mail significant challenges. setting). An apprentice who successfully delivery in the Washington, DC area has C. Grant Awards. The WB is soliciting completes an ATELS registered been erratic due to concerns involving proposals on a competitive basis for the program, which usually requires 3 to 5 anthrax contamination. All applicants WANTO program. The WB anticipates years, is awarded a certificate of must take this into consideration when awarding grants of $50,000 to $100,000 completion. An ATELS-registered preparing to meet the application to approximately 10 grantees to conduct program is one in which employers, or deadline. You assume the risk for innovative projects that comply with the groups of employers, and unions design, ensuring a timely submission; that is, if, goals set forth in the WANTO Act and organize, manage, and finance because of these mail problems, the this SGA. The period of performance apprenticeship programs under the Department does not receive an begins September 30, 2003, and ends on standards developed and registered with application or receives it too late to give September 29, 2004. The initial ATELS or ATELS-recognized State it proper consideration, even if it was performance period may be extended Apprenticeship Agencies. Employers, or timely mailed, the Department is not once, for up to three months, at no groups of employers, and unions also required to consider the application. additional cost to DOL, so that a grantee select apprentices who are trained to Therefore, it is recommended that you can finish its final report. Each meet certain predetermined confirm receipt of your application by application shall clearly state the occupational standards. For more

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information, see the ATELS Web site at 2. Documentation of applicant 4. A copy of the most current Indirect http://www.doleta.gov/atels_bat/. eligibility, as described in part II of this Cost Rate Agreement issued by the High-technology occupations are notice. cognizant federal agency, if applicable. those in which cutting-edge, state-of- 3. A 2-page abstract, summarizing the 5. Applications from a consortium of the-art technologies are used. The proposed project. organizations also must include a copy technologies shape the design, 4. Documentation of its experience, of the consortium agreement and must development, and introduction of new capability, and qualifications for identify the consortium that will act as products and innovative production providing TA to E/LU for the purpose of the administrative entity for the project. processes. These scientific, technical recruiting, training, hiring and retaining No member of a consortium shall make and engineering occupations require in- women in A/NTO, as described in part a separate application under his grant depth knowledge of the theories and IV, section A1 ‘‘Organizational program. In addition, the agreement principles of science, engineering, and Overview’’ of this notice. must specify the consortium’s mathematics, acquired through post- 5. Documentation of commitments arrangements for handling the secondary specialized education. For from a minimum of six (6) up to a administrative and financial the purposes of this solicitation, this maximum of eight (8) E/LU to receive responsibilities for the program. definition also includes other TA, and a description of the E/LU’s 6. The applicants must include the occupations which have many high-tech previous experience in recruiting, Assurances and Certifications Signature aspects, for example, repairing the training, placing and retaining women Page. products used in high-tech industries. in A/NTO, as described in part iv, Potential applicants who do not have CBO (Community-Based section A2 ‘‘Established Employer and the current version of the standard grant Organization) is a private nonprofit Labor Union Linkages’’ of this notice. forms 424 and 424A listed above can organization, which may be faith-based, 6. A Statement of Work as described download them from the following that is representative of a community or in part IV section A3 ‘‘Scope of WANTO OMB Web site address: http:// a significant segment of a community, Project and Projected Outcomes’’ of this www.whitehouse.gov/omb/grants/ and that has demonstrated experience notice. grants_forms.html. The Assurances and administering programs that train 7. A list of all items for which grant Certifications Signature Page will be women for A/NTO. funds will be expended. Do not include available on the WB WANTO Web site at http://www.dol.gov/wb/nontra.htm. Part II. Eligible Applicants any cost information, only expenditure items. An applicant must be a community- Part IV. Evaluation Criteria and 8. The CBO’s budget and major Selection Process based organization. That is, it must: funding sources for the past three (3) • Be a private, nonprofit organization. years, including foundation and Technical proposals will be carefully A public body such as a governmental government funds, as well as other reviewed by an evaluation panel using body, public school, college, or hospital types of funding. the following criteria under section A of is not a CBO. this part. Up to 115 points may be • Represent a community or a B. Cost Proposal awarded to an application. This total is significant segment of a community. The Cost Proposal is a physically based on up to 100 points for the • Have demonstrated experience separate document and must not be required information described in A. 1, administering programs that train included within the twenty-page limit 2, and 3 below, and up to 15 bonus women for A/NTO. of the technical proposal. The Cost points for special program emphasis In addition, a CBO must not be Proposal must include the following: described in A. 4 below. The ranked classified under the IRS Tax Code as a 1. A Standard Form (SF) 424, scores of the proposals will serve as the 501(c)(4) entity. ‘‘Application for Federal Assistance.’’ primary basis for selection of applicants All proposals must document that All copies of the SF 424 must have for a potential award in accordance with these eligibility requirements have been, original signatures of the legal entity the process in section B of this part. and will continue to be, satisfied. applying for grant funding. Applicants A. Technical Evaluation Criteria/Points A faith-based organization is an must indicate on the SF 424 the eligible applicant provided it meets the organizations IRS status. The Catalogue 1. Organizational Overview (Up to 20 eligibility requirements stated above. of Federal Domestic Assistance (CFDA) Points Awarded) A consortium of CBOs may apply for number for this program is 17.700, The applicant must demonstrate its a grant provided they include a copy of which should be entered on the SF 424, experience, capability and qualifications the consortium agreement and identify block 10. for administering a grant project to the entity/entities that will administer 2. A certification prepared within the provide technical assistance to E/LU. the grant. last six (6) months, attesting to the The applicant must: Applications that fail to establish adequacy of the entity’s fiscal (a) Describe the organization’s eligibility according to these criteria management and accounting systems to experience and leadership in providing will not be evaluated. account for and safeguard Federal funds technical assistance to E/LU for the Part III. Application Contents properly. The certification should be purpose of recruiting, training, placing obtained as follows: and retaining women in A/NTO. A. Technical Proposal a. For incorporated organizations, a (b) Highlight the qualifications of the The technical proposal text is limited certification from a Certified Public key staff and the organizational to twenty (20) 81⁄2 by 11 inch pages (not Accountant or structure that would ensure the success including the Table of Contents and any b. For other applicants, their of the project. Include the CBO’s attachments), numbered, double-spaced, employers’ identification number (EIN) organizational chart and the names and single-sided, in 8 to 12 pitch (font size). issued by the IRS; full resumes of all primary staff The following information is required: 3. Budget Information Form 424A, managing the grant project. 1. A Table of Contents, listing the with a narrative of description of each (c) Include job descriptions which application sections. line item. identify all key tasks, the hours required

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for the completion of such tasks, and the 3. Scope of WANTO Project and experience or indicate their plans to persons responsible for completing each Projected Outcomes (Up to 60 Points provide one or more of the following: task. Awarded) a. Opportunities for women to be (d) Indicate if tradeswomen or women The applicant must demonstrate placed and retained in A/NTO in high in nontraditional occupations serve as comprehensive, targeted, and effective technology occupations. (Up to 5 points active members of the organization, as technical assistance to be provided to E/ awarded.) either employed staff or as board LU with WANTO funding. The b. Services for disabled women to be members. applicant must also project the types placed in A/NTO. (Up to 5 points and amounts of successful outcomes awarded.) (e) Where applicable, differentiate c. Mentoring services to at least one that can reasonably be expected as a between the CBO and any proposed other CBO that is providing technical result of the TA provided with WANTO consultants or subcontractors, providing assistance to E/LU. (Up to 5 points information on each of the above. funding. The WB considers the successful placement of women in awarded.) 2. Established Employer and Labor apprenticeships and nontraditional B. Total Score Union Linkages (Up to 20 Points occupations the primary successful Awarded) The review panel’s recommendations outcome a grantee can achieve with are advisory in nature and not binding WANTO funding. on the Grant Officer. Final awards will The applicant must demonstrate The applicant must include a be made based on the best interest of the commitments from a minimum of six (6) Statement of Work which: E/LU up to a maximum of eight (8) E/ (a) Details all forms of technical government, including, but not limited LU to receive technical assistance assistance to be provided to the E/LU to, such factors as technical quality, during the grant award period. The identified in the previous section, geographic balance, occupational and/or applicant must also demonstrate a level ‘‘Established Employer and Labor Union industrial impact, and past grant of understanding of the E/LU’s previous Linkages.’’ (According to the WANTO performance. The submission of a experiences with recruitment, training, Act, technical assistance provided with successful previous application for a placement, and retention of women in WANTO grant funds may include: (1) WANTO grant from any prior year does A/NTO sufficient to enable the Developing outreach and orientation not guarantee an award under this applicant to provide targeted technical sessions to recruit women into the solicitation. A previous grantee’s failure assistance. The applicant must: employers’ apprenticeable occupations to complete a WANTO grant project (a) Document commitments (in the and nontraditional occupations; (2) within the grant award period, or failure form of written agreements or letters) developing preapprenticeable to provide required reports in a timely from a minimum of six (6) E/LU up to occupations or nontraditional skills manner are aspects of past grant a maximum of eight (8) E/LU to receive training to prepare women for A/NTO; performance that may result in denial of technical assistance for the purpose of (3) providing ongoing orientations for E/ a 2003 grant. training or employing women in A/ LU and workers on creating a successful Although the government reserves the NTO. As stated in the WANTO Act, at environment for women in A/NTO; (4) right to award on the basis of the a minimum such agreements or letters setting up support groups and applicant’s initial submissions, the should include: (1) A description of the facilitating networks for women in A/ government may establish a competitive need for technical assistance; (2) a NTO on or off the job site to improve range or technically acceptable range description of the types of their retention; (5) setting up a local based upon proposal evaluation for the apprenticeable occupations or computerized data base referral system purpose of selecting qualified nontraditional occupations in which the to maintain a current list of applicants. The government reserves the employer or labor union would like to tradeswomen who are available for right to ask for clarification or hold train or employ women; (3) assurances work; (6) serving as a liaison between discussion, but may elect to award a that there are or will be suitable and tradeswomen and E/LU to address grant without such discussion. The appropriate positions available in the workplace issues related to gender; and Grant Officer’s determination of award apprenticeable occupations program or (7) conducting exit interviews with under this SGA is the final agency in the nontraditional occupations being tradeswomen to evaluate their on-the- action. targeted; and (4) commitments that job experience and to assess the Part V. Deliverables effectiveness of the program.) reasonable efforts shall be made to place This section is provided so that qualified women in apprenticeable (b) Documents any leveraging or co- funding anticipated for the applicants may more accurately occupations or nontraditional estimate the staffing budgetary occupations. accomplishment of the proposed project. This must include a description requirements when preparing their (b) Document the previous programs of the value-added of the WANTO grant, proposal. Applicants are to exclude and experiences, and success or lack i.e., what technical assistance will be from their cost proposal the cost of any thereof, of the E/LU in recruiting, provided to E/LU as a result of WANTO requested travel to Washington, DC. training, placing, and retaining women grant funding? A. Post Grant Award Conference. in A/NTO. Such documentation may (c) Describes the outcomes the include descriptions of previous applicant projects as a result of WANTO No later than eight (8) weeks after an outreach and orientation provided to funding. This must include the number award, the grantees shall meet with the women, mentoring programs, support of women to be placed in (1) pre- WB and ATELS at the Post-Award groups, networks, workplace apprenticeships; (2) apprenticeships; Conference to discuss the project, consultations, employee and and (3) nontraditional occupations. related components and TA; timelines; supervisory workshops, and other technical assistance outcomes; workplace-specific strategic planning to 4. Bonus Points (Up to 15 Points assessment for comment; and final increase the participation of women in Awarded) approval. The grantees and the WB will apprenticeship and nontraditional Bonus points will be awarded for discuss and make decisions on the occupations. projects that demonstrate their following program activities:

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1. The proposed TA commitments for 3. In addition, between scheduled 29 CFR part 95—Uniform employment, registered apprenticeship, reporting dates, the grantee(s) shall Administrative Requirements for and related skilled nontraditional immediately inform the Women’s Grants and Cooperative Agreements occupation activities and Bureau National Office Grant Officer’s with Institutions of Higher Education, responsibilities; the number of targeted Technical Representative of significant etc. partnerships with E/LU; and the number developments affecting the ability to B. Allowable Costs of women who will be served. accomplish the work. 2. The methodology the proposed The WB shall determine what partnership will use to support/change E. Final Report constitutes allowable costs in management and employee attitudes to 1. The Final Report shall cover accordance with the following promote female workers in A/NTO. findings, final performance data, applicable Federal cost principles: (1) 3. The types of systemic change outcome results, an assessment of the State and Local Government—OMB anticipated by the TA strategies that grant project, and any employer or labor Circular A–87; (2) Educational will be incorporated into ongoing organization plans for follow-up of Institutions—OMB Circular A–21; (3) employer recruitment, hiring, training, participants. It shall include an Nonprofit Organizations—OMB Circular and promotion of women in A/NTO. Executive Summary of no more than A–122; and (4) Profit-making 4. The occupational, industrial, and three (3) pages. Commercial Firms—48 CFR Part 31. geographical impact anticipated. 5. The supportive services to be 2. No later than ninety (90) days after C. Grant Nondiscrimination Assurances provided to employers and women after the expiration of the grant award, the As a condition of the awards, successful placement into A/NTO. grantee(s) shall submit two (2) copies of applicants must certify that they will The WB and ATELS will provide the camera-ready final report, each comply fully with the further input orally or in writing, if bound in a professional manner in a nondiscrimination and equal necessary, within ten (10) working days loose-leaf notebook. These materials opportunity provisions of the following after the Post-Award Conference. must be paid for with grant funds. laws: 3. Upon request of either the Women’s B. Grant Plan of Action. 29 CFR part 31—Nondiscrimination in Bureau or the grantee, the grantee shall Federally-assisted programs of the If revisions have been necessary, no submit a draft final report no more than Department of Labor, effectuation of later than ten (10) weeks after an award, sixty (60) days after the expiration of the title VI of the Civil Rights Act of 1964. the grantees and the WB will confirm grant award. The Women’s Bureau will 29 CFR part 32—Nondiscrimination on the ‘‘plan of action’’ and detailed time- then review the draft report, consult the Basis of Disability in Programs line for program implementation. with ATELS as necessary, and provide and Activities Receiving or Benefiting written comments to the grantee within C. Grant Implementation. from Federal Assistance. fifteen (15) days of receipt. (Implementing section 504 of the No later than twelve (12) weeks after Part VII. Grant Requirements Rehabilitation Act, 29 U.S.C. 794) an award, the grantee(s) shall have 29 CFR part 36—Nondiscrimination on begun providing E/LU with TA to A. Administrative Standards and the Basis of Sex in Education recruit, select, train, place, retain, and Provisions Programs or Activities Receiving otherwise prepare women for A/NTO, Federal Financial Assistance. with progress to be measured in terms Except as specifically provided, DOL acceptance of a proposal and an award (Implementing title IX of the of employment growth and rising Education Amendments of 1972, 20 earnings. of Federal funds to sponsor any program(s) does not provide a waiver of U.S.C. 1681 et seq.) D. Quarterly Reports any grant requirements and/or The applicant must include 1. No more than thirty (30) calendar procedures. For example, the OMB assurances and certifications that it will days after the end of each quarter, the Grants Management circulars (available comply with these laws in its grant grantee shall submit a progress report of on the OMB Web site at http:// application. The assurances and work done under this grant. www.whitehouse.gov/omb/grants/ certifications are attached as Appendix 2. Quarterly reports shall generally grants_circulars.html) require, and an C. contain brief information on each of the entity’s procurement procedures must In addition, this program is subject to following: require, that all procurement the provisions of the ‘‘Jobs for Veterans (a) A comparison of actual transactions will be conducted, as Act,’’ Public Law 107–288, which accomplishments with the goals and practical, to provide open and free provides priority of service to veterans objectives established for the period. competition. If a proposal identifies a and spouses of certain veterans for the This must include discussion of specific entity to provide the services, receipt of employment, training, and placements in pre-apprenticeship the DOL award does not provide the placement services in any job training programs, apprenticeships and justification or basis to sole-source the program directly funded, in whole or in nontraditional jobs, giving the name and procurement, i.e., avoid competition. part, by the Department of Labor. Please address of each workplace/company The grants awarded under this SGA note that, to obtain priority of service, involved; and TA provided to E/LU, shall be subject to the following a veteran must meet those programs’ giving the E/LU name and address as administrative standards and provisions eligibility requirements. Comprehensive well as the nature of the TA provided. as applicable: policy guidance is being developed and (b) Reasons why established goals will be issued in the near future. were not met, if appropriate. 29 CFR part 97—Uniform (c) Any problems that may impede the Administrative Requirements for Part VIII. Paperwork Reduction Act performance of the grant and the Grants and Cooperative Agreements to Notice (Public Law 104–13) proposed corrective action. State and Local Governments. This collection of information is (d) Any changes in the proposed work 29 CFR part 96—Federal Standards for approved under the Office of to be performed during the next Audit of Federally Funded Grants, Management and Budget (OMB) control reporting period. Contracts, and Agreements. number 1225–0080, which expires 12/

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31/05. Persons are not required to Send comments regarding this burden Signed in Washington, DC, this 12th day of respond to a collection of information estimate or any other aspect of this June, 2003. unless it displays a currently valid OMB collection of information, including Lawrence J. Kuss, control number. The public reporting suggestions for reducing this burden to Grant Officer. burden for this collection of information the Women’s Bureau, U.S. Department Appendix is estimated to average six (6) to twelve of Labor, Room S3311, 200 Constitution (12) hours to complete the grant Ave., NW., Washington, DC 20210, to A. Standard Form 424: Application for application; two (2) to five (5) hours for Federal Assistance the attention of Diane Faulkner. Please B. Standard Form 424A: Budget quarterly reports; and four (4) to ten (10) reference OMB control number 1225– Information—Non-Construction hours for the final report. These 0080. Programs estimates include the time for reviewing C. Assurances and Certifications Signature instructions, researching existing data Page sources, gathering and maintaining the D. Survey on Ensuring Equal Opportunity for data needed, and completing and Applicants, OMB No. 1225–0083 reviewing the collection of information. BILLING CODE 4510–23–P

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[FR Doc. 03–15344 Filed 6–17–03; 8:45 am] regulations for persons in Agreement authorize release of its facility in East BILLING CODE 4510–23–C States. Part 150 also defines activities in Millstone, New Jersey for unrestricted Agreement States and in offshore waters use and has prepared an Environmental over which NRC regulatory authority Assessment (EA) in support of this NUCLEAR REGULATORY continues, including certain information action in accordance with the COMMISSION collection requirements. The requirements of 10 CFR Part 51. Based information is needed to permit NRC to on the EA, the NRC has concluded that Agency Information Collection make reports to other governments and a Finding of No Significant Impact Activities: Submission for the Office of the International Atomic Energy Agency (FONSI) is appropriate. Management and Budget (OMB) in accordance with international Review; Comment Request agreements. The information is also II. EA Summary used to carry out NRC’s safeguards and The purpose of the proposed action is AGENCY: Nuclear Regulatory inspection programs. to allow for the release of the licensee’s Commission (NRC). A copy of the final supporting East Millstone, New Jersey facility for ACTION: Notice of the OMB review of statement may be viewed free of charge unrestricted use. Aventis information collection and solicitation at the NRC Public Document Room, One Pharmaceuticals, Inc. has been of public comment. White Flint North, 11555 Rockville authorized by NRC since August 10, Pike, Room O–1 F21, Rockville, MD 2000, to use radioactive materials for SUMMARY: The NRC has recently 20852. OMB clearance requests are submitted to OMB for review the research and development including available at the NRC worldwide Web animal studies at the site. On January following proposal for the collection of site: http://www.nrc.gov/public-involve/ information under the provisions of the 20, 2003, Aventis Pharmaceuticals, Inc. doc-comment/omb/index.html. The requested that NRC release the facility Paperwork Reduction Act of 1995 (44 document will be available on the NRC U.S.C. Chapter 35). The NRC hereby for unrestricted use. Aventis home page site for 60 days after the Pharmaceuticals, Inc. has conducted informs potential respondents that an signature date of this notice. agency may not conduct or sponsor, and surveys of the facility and determined Comments and questions should be that the facility meets the license that a person is not required to respond directed to the OMB reviewer listed to, a collection of information unless it termination criteria in Subpart E of 10 below by July 18, 2003. Comments CFR Part 20. displays a currently valid OMB control received after this date will be number. considered if it is practical to do so, but III. Finding of No Significant Impact 1. Type of submission, new, revision, assurance of consideration cannot be or extension: Revision. The NRC staff has evaluated Aventis given to comments received after this Pharmaceuticals, Inc.’s request and the 2. The title of the information date. Bryon Allen, Office of Information collection: 10 CFR part 150, results of the surveys and has concluded and Regulatory Affairs (3150–0032), that the completed action complies with ‘‘Exemptions and Continued Regulatory NEOB–10202, Office of Management Authority in Agreement States and in the criteria in Subpart E of 10 CFR part and Budget, Washington, DC 20503. 20. The staff has prepared the EA Offshore Waters under Section 274’’. Comments can also be submitted by (summarized above) in support of the 3. The form number if applicable: Not telephone at (202) 395–3087. applicable. The NRC Clearance Officer is Brenda proposed license amendment to 4. How often the collection is Jo. Shelton, 301–415–7233. terminate the license and release the required: 10 CFR 150.16(b), 150.17(c), facility for unrestricted use. On the basis and 150.19(c) require the submission of Dated at Rockville, Maryland, this 11th day of the EA, NRC has concluded that the of June, 2003. reports following specified events, such environmental impacts from the For the Nuclear Regulatory Commission. as the theft or unlawful diversion of proposed action are expected to be licensed radioactive material. The Brenda Jo. Shelton, insignificant and has determined not to source material inventory reports NRC Clearance Officer, Office of the Chief prepare an environmental impact required under 10 CFR 150.17(b) must Information Officer. statement for the proposed action. be submitted annually by certain [FR Doc. 03–15349 Filed 6–17–03; 8:45 am] IV. Further Information licensees. BILLING CODE 7590–01–P 5. Who will be required or asked to The EA and the documents related to report: Agreement State licensees this proposed action, including the authorized to possess source or special NUCLEAR REGULATORY application for the license amendment nuclear material at certain types of COMMISSION and supporting documentation, are facilities, or at any one time and [Docket No. 030–08963] available for inspection at NRC’s Public location in greater than specified Electronic Reading Room at http:// amounts. Notice of Finding of No Significant www.nrc.gov/reading-rm/adams.html 6. An estimate of the number of Impact and Availability of (ADAMS Accession Nos. ML031620018, annual responses: 12. Environmental Assessment for ML030280251, ML030870319, and 7. The estimated number of annual License Amendment of Materials ML031611141. These documents are respondents: 9 Agreement State License No. 29–15354–01, Aventis also available for inspection and licensees. Pharmaceuticals, Inc, East Millstone, copying for a fee at the Region I Office, 8. An estimate of the total number of NJ 475 Allendale Road, King of Prussia, PA hours needed annually to complete the 19406. Any questions with respect to requirement or request: 35 hours. I. Introduction this action should be referred to Judy 9. An indication of whether Section The U.S. Nuclear Regulatory Joustra, Nuclear Materials Safety Branch 3507(d), Pub. L. 104–13 applies: Not Commission (NRC) is considering the 2, Division of Nuclear Materials Safety, applicable. issuance of a license amendment to Region I, 475 Allendale Road, King of 10. Abstract: 10 CFR part 150 Aventis Pharmaceuticals, Inc. for Prussia, Pennsylvania, 19406, telephone provides certain exemptions from NRC Materials License No. 29–15354–01, to (610) 337–5355, fax (610) 337–5269.

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Dated at King of Prussia, Pennsylvania this Technology, Securities and Exchange Applicants: Bank, DKWS and PIMCO 11th day of June, 2003. Commission, 450 Fifth Street, NW, Funds: Multi-Manager Series (the For the Nuclear Regulatory Commission. Washington, DC 20549. Comments must ‘‘Trust’’). John D. Kinneman, be submitted to OMB within 30 days of Filing Dates: The application was Chief, Nuclear Materials Safety Branch 2, this notice. filed on July 19, 2002 and amended on Division of Nuclear Materials Safety, Region Dated: June 10, 2003. June 2, 2003. I. Hearing or Notification of Hearing: An Margaret H. McFarland, [FR Doc. 03–15348 Filed 6–17–03; 8:45 am] order granting the application will be Deputy Secretary. BILLING CODE 7590–01–P issued unless the Commission orders a [FR Doc. 03–15311 Filed 6–17–03; 8:45 am] hearing. Interested persons may request BILLING CODE 8010–01–P a hearing by writing to the SECURITIES AND EXCHANGE Commission’s Secretary and serving COMMISSION applicants with a copy of the request, SECURITIES AND EXCHANGE personally or by mail. Hearing requests Submission for OMB Review; COMMISSION should be received by the Commission Comment Request by 5:30 p.m. on July 7, 2003, and should [Release No. IC–26073; 812–12859] be accompanied by proof of service on Upon Written Request, Copies Available applicants, in the form of an affidavit, From: Securities and Exchange Commission, Dresdner Bank AG, et al.; Notice of or, for lawyers, a certificate of service. Office of Filings and Information Services, Application Washington, DC 20549. Hearing requests should state the nature Extension: June 11, 2003. of the writer’s interest, the reason for the request, and the issues contested. Form S–11, OMB Control No. 3235–0067, AGENCY: Securities and Exchange SEC File No. 270–064 Commission (‘‘Commission’’). Persons may request notification of a hearing by writing to the Commission’s Notice is hereby given that pursuant ACTION: Notice of application for an Secretary. to the Paperwork Reduction Act of 1995 order under section 12(d)(1)(J) of the ADDRESSES: Secretary, Commission, 450 (44 U.S.C. 3501 et seq.) the Securities Investment Company Act of 1940 (the Fifth Street, NW., Washington, DC and Exchange Commission ‘‘Act’’) for an exemption from section 20549–0609. Applicants, c/o Robert (‘‘Commission’’) has submitted to the 12(d)(1) of the Act, under sections 6(c) Boyd, Dresdner Bank AG, New York Office of Management and Budget and 17(b) of the Act for an exemption Branch, 75 Wall Street, 31st Floor, New request for extension of the previously from section 17(a) of the Act, under York, NY 10005. approved collection of information section 6(c) of the Act for an exemption discussed below. from section 17(e) of the Act, and under FOR FURTHER INFORMATION CONTACT: Form S–11 is the registration section 17(d) of the Act and rule 17d– Emerson S. Davis, Sr., Senior Counsel, statement form used to register 1 under the Act to permit certain joint at (202) 942–0714, or Nadya B. Roytblat, securities issued in real estate transactions. Assistant Director, at (202) 942–0564 investment trusts by issuers whose (Division of Investment Management, business is primarily that of acquiring Summary of Application: Applicants Office of Investment Company and holding investment interest in real request an order to permit: (a) Certain Regulation). estate under the Securities Act of 1933. registered investment companies and SUPPLEMENTARY INFORMATION: The The information filed with the certain private investment companies to following is a summary of the Commission permits verifications of use cash collateral from securities application. The complete application compliance with securities law lending transactions (‘‘Cash Collateral’’) may be obtained for a fee from the requirements and assures public to purchase shares (‘‘Shares’’) of certain Commission’s Public Reference Branch, availability and dissemination of such registered open-end management 450 5th Street, NW., Washington DC information. Information provided is investment companies (‘‘Registered 20549–0102 (telephone (202) 942–8090). mandatory. Approximately 150 issuers Investment Funds’’) and private file Form S–11 annually and it takes investment companies (‘‘Private Applicants’ Representations approximately 1,892 hours per response Investment Funds’’, together with the 1. The Bank, a German public limited for a total burden of 283,800 hours. It is Registered Investment Funds, the company, is wholly-owned by Allianz estimated that 25% of the total burden ‘‘Investment Funds’’); (b) certain AG (‘‘Allianz’’), a German international hours (70,950 reporting burden) is registered investment companies to pay financial services company. DKWS, prepared by the company. Finally, an affiliated lending agent a fee based registered as a broker-dealer under the persons who respond to the collection on a share of the revenue derived from Securities Exchange Act of 1934, is a of information contained in Form S–11 securities lending activities; (c) wholly-owned subsidiary of Allianz. are not required to respond unless the Dresdner Bank AG (‘‘Bank’’), Dresdner The Trust, a Massachusetts business form displays a currently valid control Kleinwort Wassertein Securities LLC trust, is an open-end management number. (‘‘DKWS’’) and any other Dresdner investment company registered under Written comments regarding the Entity (as defined below) (each, an the Act and advised by PIMCO Advisors above information should be directed to ‘‘Affiliated Borrower’’) to engage in Fund Management LLC, an investment the following persons: (i) Desk Officer principal transactions with, and receive adviser under the Investment Advisers for the Securities and Exchange brokerage commissions from, certain Act of 1940 that is an indirect Commission, Office of Information and registered investment companies that subsidiary of Allianz. Series of the Trust Regulatory Affairs, Office of are affiliated persons because they hold and any other registered management Management and Budget, Room 10102, 5% or more of the outstanding voting investment companies or series thereof New Executive Office Building, securities of an Investment Fund; and currently or in the future advised by the Washington, DC 20503; and (ii) Kenneth (d) certain registered investment Bank or any entity controlling, A. Fogash, Acting Associate Executive companies to lend portfolio securities to controlled by, or under common control Director/CIO, Office of Information Affiliated Borrowers. with the Bank (the Bank and each

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entity, a ‘‘Dresdner Entity’’) are referred Personnel providing day-to-day lending the securities of other investment to as ‘‘Affiliated Lending Funds.’’ 1 agency services to the Affiliated companies, more than 10% of the 2. The New York branch of the Bank Lending Funds will not provide acquiring company’s total assets. operates a securities lending program investment advisory services to the Section 12(d)(1)(B) of the Act provides (‘‘Program’’). Lenders in the Program Affiliated Lending Funds or participate that no registered open-end investment include, among others: (a) Affiliated in any way in the selection of portfolio company may sell its securities to Lending Funds, (b) other registered securities for, or other aspects of the another investment company if the sale management investment companies or management of, the Affiliated Lending will cause the acquiring company to series thereof (‘‘Other Lending Funds,’’ Funds. The duties to be performed by own more than 3% of the acquired together with the Affiliated Lending the Bank as lending agent with respect company’s voting stock, or if the sale Funds, the ‘‘Registered Lending Funds’’) to any Registered Lending Fund will not will cause more than 10% of the and (c) investment entities excluded exceed the parameters described in acquired company’s voting stock to be from the definition of investment Norwest Minnesota, N.A., SEC No- owned by investment companies. company under section 3(c)(1) or 3(c)(7) Action Letter (pub. avail. May 25, 1995). Section 12(d)(1)(J) of the Act provides of the Act (‘‘Private Lending Funds,’’ The Bank will not purchase Shares of an that the Commission may exempt any together with the Registered Lending Investment Fund with Cash Collateral person or transaction from any Funds, the ‘‘Lending Funds’’). unless participation in the Program has provision of section 12(d)(1) if and to 3. The Registered Investment Funds been approved by a majority of the the extent that the exemption is will be open-end management directors or trustees of the Registered consistent with the public interest and investment companies registered under Lending Fund that are not ‘‘interested the protection of investors. the Act and advised by a Dresdner persons’’ within the meaning of section 2. Applicants request an exemption Entity. The Private Investment Funds 2(a)(19) of the Act. under section 12(d)(1)(J) to permit the will rely on section 3(c)(1) or 3(c)(7) of 5. When a securities loan is Lending Funds to invest Cash Collateral the Act and will be advised by a collateralized by Cash Collateral, the in Shares of the Registered Investment Dresdner Entity. Shares of the Borrower is entitled to receive a fixed Funds in excess of the limits imposed Investment Funds will not be subject to return on the collateral for the term of by section 12(d)(1)(A), and each any sales load, redemption fee, asset- the loan (‘‘Borrower’s Rebate’’). The Registered Investment Fund to sell its based sales charge or service fee, as difference between the Borrower’s Shares to the Lending Funds in excess defined in rule 2830(b)(9) of the Rebate and the actual return on the of the limits in section 12(d)(1)(B). Conduct Rules of the National investment of the collateral will be 3. Applicants state that none of the Association of Securities Dealers, Inc. divided between the Lending Fund and abuses meant to be addressed by section (‘‘NASD Conduct Rules’’). Certain the Bank in accordance with the terms 12(d)(1) of the Act will be created by the Investment Funds will hold themselves of the Lending Agreement. When the proposed investment of Cash Collateral out as money market funds and will collateral is not Cash Collateral, the in the Registered Investment Funds. comply with rule 2a–7 under the Act. Lending Agreement will set a loan fee Applicants represent that the proposed Other Investment Funds will seek to to be paid by the Borrower, which likely arrangement will not result in an achieve a high level of current income will approximate the return the Lending inappropriate layering of fees because consistent with the preservation of Fund would receive had the Borrower Shares of the Investment Funds will be sold without a sales load, redemption capital and the maintenance of liquidity delivered Cash Collateral. The amount and will invest in high quality securities fee, asset-based sales charge or service of the fee will be divided between the with relatively short maturities. fee as defined in the NASD Conduct Lending Fund and the Bank in 4. Under the Program, the Bank will Rules. Applicants also represent that no accordance with the terms of the enter into an agreement (‘‘Lending Investment Fund will acquire shares of Agreement’’) with each Lending Fund Lending Agreement. 6. The applicants request relief to any other investment company in excess that appoints the Bank to serve as its permit: (a) The Lending Funds to invest of the limits contained in section lending agent and authorizes the Bank 12(d)(1)(A) of the Act. Cash Collateral in the Investment to enter into a master borrowing 4. Sections 17(a)(1) and 17(a)(2) of the Funds, (b) the Registered Lending Funds agreement (‘‘Borrowing Agreement’’) Act prohibit an affiliated person of a to pay the Bank a fee based on a share with persons designated by the Lending registered investment company, or any Fund as eligible to borrow its portfolio of the revenue derived from securities affiliated person of the affiliated person securities (each a ‘‘Borrower’’). Under lending activities, (c) Affiliated Lending (‘‘second-tier affiliate’’) from selling any the Lending Agreement, the Bank will Funds to lend portfolio securities to the security to, or purchasing any security invest any Cash Collateral received in Affiliated Borrowers, and (d) a Dresdner from, the registered investment the Program on behalf of a Lending Entity to engage in principal company. Section 2(a)(3) of the Act Fund directly in various types of transactions with, and receive brokerage defines an ‘‘affiliated person’’ of another instruments, accounts and investment commissions from, the Other Lending person to include: any person directly vehicles, including Shares of one or Funds. or indirectly owning, controlling, or more Investment Funds. The Lending Applicants’ Legal Analysis holding with power to vote 5% or more Agreement and the Borrowing of the outstanding voting securities of Agreement will also establish for each A. Investment of Cash Collateral by the the other person; any person 5% or transaction the initial and on-going Lending Funds in the Investment Funds more of whose outstanding voting collaterization requirements and the 1. Section 12(d)(1)(A) of the Act securities are directly or indirectly types of collateral that may be accepted. provides that no registered investment owned, controlled, or held with power company may acquire securities of to vote, by such other person; any 1 All existing Affiliated Lending Funds that another investment company person directly or indirectly controlling, currently intend to rely on the requested relief have representing more than 3% of the controlled by, or under common control been named as applicants. Any other existing or future entity may rely on the requested relief only acquired company’s outstanding voting with, the other person; and, in the case in accordance with the terms and conditions of the stock, more than 5% of the acquiring of an investment company, its application. company’s total assets, or, together with investment adviser. Control is defined

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in section 2(a)(9) of the Act to mean that the Registered Lending Funds will 10. Applicants state that the ‘‘the power to exercise a controlling only be permitted to invest in an investment by the Lending Funds in influence over the management or Investment Fund if that Investment Shares will be on the same basis and policies of a company, unless such Fund invests in instruments that the will be indistinguishable from any other power is solely the result of an official Registered Lending Fund has previously shareholder account maintained by the position with such company.’’ determined are acceptable medium for Investment Funds. In addition, 5. Applicants state that because the investment for Cash Collateral. applicants state that all investors in Dresdner Entities will serve as Applicants state that Cash Collateral of Shares will be subject to the same investment advisers to Affiliated a Registered Lending Fund that is a eligibility requirements imposed by the Lending Funds and the Investment money market fund will not be used to Investment Funds and all Shares will be Funds, the Dresdner Entities could be acquire Shares of any Investment Fund priced in the same manner and will be deemed to control the Affiliated that does not comply with rule 2a–7 redeemable under the same terms. Lending Funds and the Investment under the Act. Applicants further state B. Payment of Lending Agent Fees to the Funds, and the Dresdner Entities are that the investment of Cash Collateral Bank under common control. Accordingly, will comply with all present and future the Affiliated Lending Funds and the Commission and staff positions 1. Applicants also believe that a Investment Funds may be deemed to be concerning securities lending lending agent agreement between the under common control and affiliated arrangements. Applicants also state that Registered Lending Funds and the Bank, persons of each other. Further, the Private Investment Funds will under which compensation is based on applicants state that if any Other comply with the provisions of the Act a share of the revenue generated by the Lending Fund acquires 5% or more of dealing with affiliated transactions, Program, may be a joint enterprise or an Investment Fund’s Shares, the leveraging and issuing senior securities, other joint arrangement within the Investment Fund may be deemed an and rights of redemption. meaning of section 17(d) of the Act and affiliated person of the Other Lending 8. Section 17(d) of the Act and rule rule 17d–1 under the Act. Consequently, Fund. As a result, applicants state that 17d–1 under the Act prohibit any applicants request an order permitting the sale of Shares of the Investment affiliated person or principal the Registered Lending Funds to pay, Funds to the Registered Lending Funds, underwriter for a registered investment and the Bank, as lending agent, to and the redemption of such Shares in company, or any second tier affiliate, accept fees based on a share of the connection with the investment of Cash acting as principal, from effecting any revenue generated by securities lending Collateral may be prohibited under transaction in connection with any joint transactions under the Program. Section 17(a). enterprise or other joint arrangement or 2. Applicants propose that each 6. Section 17(b) of the Act authorizes profit sharing plan in which the Affiliated Lending Fund adopt the the Commission to exempt a transaction investment company participates, following procedures to ensure that the from section 17(a) if the terms of the without an order of the Commission. proposed fee arrangement and the other proposed transaction, including the Under rule 17d–1, in passing on terms governing the relationship with consideration to be paid or received, are applications for orders under section the Bank, as lending agent, will meet the reasonable and fair and do not involve 17(d), the Commission considers standards of rule 17d–1: overreaching on the part of any person whether the participation of the (a) In connection with the approval of concerned, and the proposed registered investment company is the Bank as lending agent for an transaction is consistent with the policy consistent with the provisions, policies, Affiliated Lending Fund and of each registered investment company and purposes of the Act and the extent implementation of the proposed fee concerned and with the general to which the participation is on a basis arrangement, a majority of the board of purposes of the Act. Section 6(c) of the different from or less advantageous than directors or trustees of the Affiliated Act authorizes the Commission to that of other participants. Lending Fund (the ‘‘Board’’), including exempt any person or transaction from 9. Applicants state that the Lending a majority of the directors or trustees any provision of the Act if the Funds (by purchasing and redeeming that are not ‘‘interested persons’’ as exemption is necessary or appropriate Shares of the Investment Funds), the defined in section 2(a)(19) of the Act in the public interest and consistent Dresdner Entities (by managing the (‘‘Independent Directors’’), will with the protection of investors and the portfolio securities of the Affiliated determine that (i) the Lending purposes fairly intended by the policy Lending Funds and Investment Funds at Agreement with the Bank is in the best and provisions of the Act. the same time that the Affiliated interests of the Affiliated Lending Fund 7. Applicants request an order under Lending Funds’ Cash Collateral is and its shareholders, (ii) the services to sections 6(c) and 17(b) of the Act to invested in Shares), the Bank (by acting be performed by the Bank are permit the Registered Lending Funds to as lending agent, investing Cash appropriate for the Affiliated Lending invest Cash Collateral in Shares of the Collateral in Shares, and receiving a Fund, (iii) the nature and quality of the Investment Funds. Applicants submit portion of the revenue generated by services provided by the Bank are at that the terms of the proposed securities lending transactions), and the least equal to those services offered and transactions, including the Investment Funds (by selling Shares to provided by others, and (iv) the fees for consideration to be paid or received, are and redeeming Shares from the Lending the Bank’s services are within the range reasonable and fair, do not involve Funds) could be deemed to be of, but in any event no higher than, the overreaching and are consistent with the participants in a joint enterprise or other fees charged by the Bank to comparable general purposes of the Act as well as joint arrangement within the meaning of unaffiliated securities lending clients for the policies of the respective Registered section 17(d) of the Act and rule 17d– services of the same nature and quality. Lending Funds. The Registered Lending 1 under the Act. Applicants request an (b) Each Affiliated Lending Fund’s Funds will purchase and redeem Shares order in accordance with section 17(d) Lending Agreement with the Bank for on the same terms and the same basis and rule 17d–1 to permit the lending agent services will be reviewed as the Shares are purchased and transactions incident to the investment annually by the Board and will be redeemed by all other shareholders of of Cash Collateral of the Lending Funds approved for continuation only if a the Investment Funds. Applicants state in the Investment Funds. majority of the Board, including a

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majority of Independent Directors, the Bank will be the product of arm’s- D. Transactions by Other Lending Funds makes the findings referred to in length bargaining. with Dresdner Entities paragraph (a) above. C. Lending to Affiliated Borrowers 1. As noted above, sections 17(a)(1), (c) In connection with the initial (2) and (3) prohibit certain principal 1. Section 17(a)(3) of the Act makes it implementation of an arrangement transactions between a registered unlawful for any affiliated person of a whereby the Bank will be compensated investment company and its affiliates. registered investment company or as lending agent based on a percentage To the extent that a Dresdner Entity and second-tier affiliate, acting as principal, of the revenue generated by an the Investment Funds are deemed to be to borrow money or other property from Affiliated Lending Fund’s participation under common control, they could be the registered investment company. in the Program, the Affiliated Lending affiliated persons of one another. Under section 2(a)(3)(C) of the Act, an Fund’s Board shall secure a certificate Applicant also asserts that each Affiliated Borrower would be deemed a from the Bank attesting to the factual Dresdner Entity that serves as second-tier affiliate of Affiliated accuracy of clause (iv) in paragraph (a) investment adviser to an Investment Lending Funds for which Dresdner above. In addition, the Board will Fund could be deemed an affiliated Entities serve as investment advisers. In request and evaluate, and the Bank shall person of the Investment Fund and a addition, applicants state that to the furnish, such information and materials second-tier affiliate of an Other Lending extent that an Affiliated Lending Fund as the Board, with and upon the advice Fund that owns 5% or more of an or Other Lending Fund acquires Shares of agents, consultants or counsel, Investment Fund. determines to be appropriate in making of an Investment Fund, an Affiliated 2. Applicants request relief under the findings referred to in paragraph (a) Borrower also could be deemed a sections 6(c) and 17(b) from section above. Such information shall include, second-tier affiliate of the Affiliated 17(a) to permit principal transactions in any event, information concerning Lending Fund or Other Lending Fund. between Other Lending Funds and the fees charged by the Bank to other Accordingly, section 17(a)(3) would Dresdner Entities where the affiliation institutional investors for providing prohibit the Affiliated Borrowers from between the parties arises solely as a similar services. borrowing securities from the Registered result of an investment by an Other (d) The Board of each Affiliated Lending Funds. Lending Fund in Shares of the Lending Fund, including a majority of 2. As noted above, section 17(d) and Investment Funds. Applicants state that the Independent Directors, will (i) rule 17d–1 generally prohibit joint there will be no element of self-dealing determine at each regular quarterly transactions involving registered because the Dresdner Entities will have meeting that the loan transactions investment companies and their no influence over the decisions made by during the prior quarter were effected in affiliates unless the Commission has any Other Lending Fund. Applicants compliance with the conditions and approved the transaction. Applicants assert that each transaction will be the procedures set forth in the application request relief under sections 6(c) and product of arm’s length bargaining. and (ii) review no less frequently than 17(b) of the Act exempting the Because the interests of the Other annually the conditions and procedures Registered Lending Funds from section Lending Funds’ investment advisers are set forth in the application for 17(a)(3), and under section 17(d) and solely and directly aligned with those of continuing appropriateness. rule 17d–1 to permit the Registered the Other Lending Funds, applicants (e) Each Affiliated Lending Fund will Lending Funds to lend portfolio believe it is reasonable to conclude that (i) maintain and preserve permanently securities to Affiliated Borrowers. the consideration paid to or received by in an easily accessible place a written 3. Applicants state that each loan to the Other Lending Funds in connection copy of the procedures and conditions an Affiliated Borrower by an Affiliated with a principal transaction with a described in the application and (ii) Lending Fund will be made with a Dresdner Entity will be reasonable and maintain and preserve for a period of spread that is no lower than that applied fair. not less than six (6) years from the end to comparable loans to unaffiliated 3. Section 17(e) of the Act makes it 2 of the fiscal year in which any loan Borrowers. Applicants further state that unlawful for any affiliated person of a transaction pursuant to the Program at least 50% of the loans made by the registered investment company, or any occurred, the first two (2) years in an Affiliated Lending Funds, on an second-tier affiliate, acting as a broker in easily accessible place, a written record aggregate basis, will be made to connection with the sale of securities to of each such loan transaction setting unaffiliated Borrowers. Moreover, all or by that registered investment forth a description of the security loans will be made with spreads that are company, to receive from any source a loaned, the identity of the person on the no lower than those set forth in a commission for effecting the transaction other side of the loan transaction, the schedule of spreads which will be that exceeds specified limits. Rule 17e– terms of the loan transaction, and the established by each Affiliated Lending 1 provides that a commission shall be information or materials upon which Fund’s Board and a majority of the deemed an usual and customary the determination was made that each Independent Directors and monitored broker’s commission if certain loan was made in accordance with the by an officer of the Affiliated Lending procedures are followed by the procedures set forth above and the Fund. The Board, including a majority registered investment company. conditions to the application. of the Independent Directors, also will 4. Applicants request relief under 3. With respect to Other Lending review quarterly reports on all lending section 6(c) from section 17(e) to the Funds, applicants state that the activity. extent necessary to permit Dresdner affiliations with the Bank arise solely as Entities to receive fees or commissions 2 A ‘‘spread’’ is the compensation earned by a result of the investment of Cash Lending Fund from a securities loan, which for acting as broker or agent in Collateral in the Investment Funds. compensation is in the form either of a lending fee connection with the purchase or sale of Applicants state that a Dresdner Entity payable by the Borrower to the Lending Fund securities for any Other Lending Fund would not have any influence over the (when non-cash collateral is posted) or of the excess for which a Dresdner Entity becomes a retained by the Lending Fund over a rebate rate decisions made by any Other Lending payable by the Lending Fund to the Borrower second-tier affiliate solely because of the Fund, and that any fee arrangement (when Cash Collateral is posted and then invested investment by the Other Lending Fund between the Other Lending Funds and by the Lending Fund). in Shares of Investment Funds.

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5. Applicants submit that brokerage or 5. Investment in Shares of an of the fiscal year in which any similar transactions by Dresdner Entities Investment Fund by a particular transaction occurred, the first two years for the Other Lending Funds raise no Registered Lending Fund will be in in an easily accessible place, and will be possibility of self-dealing or any accordance with the guidelines subject to examination by the concern that the Other Lending Funds regarding the investment of Cash Commission and its staff. would be managed in the interest of the Collateral specified by the Registered 10. The net asset value per Share with Dresdner Entities. Applicants believe Lending Fund in the Lending respect to Shares of the Private that each transaction between an Other Agreement. A Registered Lending Investment Funds will be determined Lending Fund and a Dresdner Entity Fund’s Cash Collateral will be invested separately for each Private Investment would be the product of arm’s length in a particular Investment Fund only if Fund by dividing the value of the assets bargaining because each investment that Investment Fund has been belonging to that Private Investment adviser to an Other Lending Fund approved for investment by the Fund, less the liabilities of that Private would have no interest in benefiting a Registered Lending Fund and if that Investment Fund, by the number of Dresdner Entity at the expense of an Investment Fund invests in the types of Shares outstanding with respect to that Other Lending Fund. instruments that the Registered Lending Private Investment Fund. Fund has authorized for the investment 11. Any Private Investment Fund that Applicants’ Conditions of its Cash Collateral. operates as a money market fund and Applicants agree that any order of the 6. An Investment Fund will not uses the amortized cost method of Commission granting the requested acquire securities of any investment valuation, as defined in rule 2a-7 under relief will be subject to the following company in excess of the limits in the Act, will comply with rule 2a-7. conditions: Section 12(d)(1)(A). With respect to each such Private 7. Shares will not be subject to a sales Investment Fund, the Dresdner Entity General load, redemption fee, asset-based sales serving as investment adviser, trustee, 1. The securities lending program of charge or service fee (as defined in rule general partner or managing member each Registered Lending Fund will 2830(b)(9) of the NASD Conduct Rules). shall adopt and monitor the procedures described in rule 2a-7(c)(7) under the comply with all present and future Private Investment Funds applicable guidelines of the Act and will take such other actions as 8. Each Registered Lending Fund will are required to be taken pursuant to Commission and its staff regarding purchase and redeem Shares of a Private securities lending arrangements. these procedures. The Registered Investment Fund as of the same time Lending Funds may only purchase 2. The approval of an Affiliated and at the same price, and will receive Shares of such Private Investment Fund Lending Fund’s Board, including a dividends and bear its proportionate if the Dresdner Entity serving as majority of the Independent Directors, share of expenses on the same basis as investment adviser, trustee, general shall be required for the initial and other shareholders of the Private partner or managing member determines subsequent approvals of the Bank’s Investment Fund. A separate account on an ongoing basis that the Private service as lending agent for the will be established in the shareholder Investment Fund is in compliance with Affiliated Lending Fund pursuant to the records of the Private Investment Fund rule 2a-7. Such investment adviser, Program, for the institution of all for the account of each Registered trustee, general partner or managing procedures relating to the Program as it Lending Fund. member shall preserve for a period not relates to the Affiliated Lending Fund, 9. Each Private Investment Fund in less than six years from the date of and for any periodic review of loan which a Registered Lending Fund determination, the first two years in an transactions for which the Bank acted as invests will comply with the easily accessible place, a record of such lending agent pursuant to the Program. requirements of sections 17(a), (d), and determination and the basis upon which 3. No Registered Lending Fund will (e), and 18 of the Act as if the Private the determination was made. This purchase Shares of any Investment Investment Fund were a registered record will be subject to examination by Fund unless participation in the open-end investment company. With the Commission and its staff. Program has been approved by a respect to all redemption requests made majority of the Independent Directors of by a Registered Lending Fund, the Loans to Affiliated Borrowers the Registered Lending Fund. The Private Investment Fund will comply 12. The Affiliated Lending Funds, on Independent Directors will evaluate the with section 22(e) of the Act. The an aggregate basis, will make at least Program no less frequently than Dresdner Entity serving as investment 50% of their portfolio securities loans to annually and determine that investing adviser, trustee, general partner or unaffiliated Borrowers. Cash Collateral in the Investment Funds managing member of a Private 13. An Affiliated Lending Fund will is in the best interests of the Investment Fund will adopt procedures not make any loan to an Affiliated shareholders of the Registered Lending designed to ensure that the Private Borrower unless the income attributable Fund. Investment Fund will comply with the to such loan fully covers the transaction requirements of sections 17(a), (d), and Investment of Cash Collateral costs incurred in making the loan. (e), 18, and 22(e) of the Act, will 14. a. All loans will be made with 4. Investment in Shares of an periodically review and periodically spreads no lower than those set forth in Investment Fund by a particular update as appropriate such procedures, a schedule of spreads which will be Registered Lending Fund will be will maintain books and records established and may be modified from consistent with the Registered Lending describing such procedures, and will time to time by each Affiliated Lending Fund’s investment objectives and maintain the records required by rules Fund’s Board and by a majority of the policies. A Registered Lending Fund 31a–1(b)(1), 31a–1(b)(2)(ii), and 31a– Independent Directors (the ‘‘Schedule of that complies with rule 2a-7 under the 1(b)(9) under the Act. All books and Spreads’’). Act will not invest its Cash Collateral in records required to be maintained b. The Schedule of Spreads will set an Investment Fund that does not pursuant to this condition will be forth rates of compensation to the comply with the requirements of rule maintained and preserved for a period Affiliated Lending Funds that are 2a–7 under the Act. of not less than six years from the end reasonable and fair and that are

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determined in light of those loaned, the face amount of the securities Franklin Templeton Fund Allocator considerations set forth in the loaned, the fee received (or the rebate Series, Franklin Money Fund, Franklin application. rate remitted), the identity of the Templeton Money Fund Trust, Franklin c. The Schedule of Spreads will be Borrower, the terms of the loan, and any Federal Money Fund, Franklin Tax- uniformly applied to all Borrowers of other information or materials upon Exempt Money Fund, Franklin Mutual the Affiliated Lending Fund’s portfolio which the finding was made that each Series Fund Inc., Franklin Floating Rate securities, and will specify the lowest loan made to an Affiliated Borrower was Trust, The Money Market Portfolios allowable spread with respect to a loan fair and reasonable, and that the (collectively, the ‘‘Franklin Funds’’); of securities to any Borrower. procedures followed in making such Templeton Growth Fund, Inc., d. If a security is lent to an loan were in accordance with the Templeton Funds, Inc., Templeton unaffiliated Borrower with a spread procedures and other undertakings set Global Smaller Companies Fund, Inc., higher than the minimum set forth in forth in the application. Templeton Income Trust, Templeton the Schedule of Spreads, all comparable Capital Accumulator Fund (formerly, loans to Affiliated Borrowers will be For the Commission, by the Division of Investment Management, pursuant to Templeton Capital Accumulator Fund made at no less than the higher spread. delegated authority. Inc.), Templeton Global Opportunities e. The securities lending program for Trust, Templeton Institutional Funds, each Affiliated Lending Fund will be Margaret H. McFarland, Inc., Templeton Developing Markets monitored on a daily basis by an officer Deputy Secretary. of each Affiliated Lending Fund who is [FR Doc. 03–15312 Filed 6–17–03; 8:45 am] Trust, Templeton Global Investment Trust, Templeton Emerging Markets subject to section 36(a) of the Act. This BILLING CODE 8010–01–P officer will review the terms of each Fund (formerly Templeton Emerging loan to Affiliated Borrowers for Markets Fund, Inc.), Templeton Global comparability with loans to unaffiliated SECURITIES AND EXCHANGE Income Fund, Inc., Templeton Emerging Borrowers and conformity with the COMMISSION Markets Income Fund, Templeton China Schedule of Spreads, and will World Fund, Inc., Templeton Dragon [Investment Company Act Release No. Fund, Inc., Templeton Russia and East periodically, and at least quarterly, 26076; 812–12674] report his or her findings to the European Fund, Inc. (formerly, Affiliated Lending Fund’s Board, Franklin Gold and Precious Metals Templeton Russia Fund, Inc.) including a majority of the Independent Fund, et al.; Notice of Application (collectively, the ‘‘Templeton Funds’’) Directors. FTI Funds; (the Franklin Funds, the 15. The total value of securities June 12, 2003. Templeton Funds and the FTI Funds are loaned to any one Borrower on the AGENCY: Securities and Exchange collectively, together with any other approved list of Borrowers of securities Commission (‘‘Commission’’). registered management investment from an Affiliated Lending Fund will be ACTION: Notice of application for an company or series thereof advised by an in accordance with a schedule to be order under section 12(d)(1)(J) of the Adviser, as defined below, the approved by the Board of each Affiliated Investment Company Act of 1940 ‘‘Franklin Templeton Funds’’); Franklin Lending Fund, but in no event will the (‘‘Act’’) for an exemption from sections Advisers, Inc., Franklin Advisory total value of securities loaned to any 12(d)(1)(A) and (B) of the Act, under Services, LLC, Franklin Investment one Affiliated Borrower exceed 10% of sections 6(c) and 17(b) of the Act for an Advisory Services Inc., Franklin Mutual the net assets of the Affiliated Lending exemption from section 17(a) of the Act, Advisers, LLC, Franklin Private Client Fund, computed at market. and under section 17(d) of the Act and Group, Inc., Templeton/Franklin 16. The Boards of the Affiliated rule 17d–1 under the Act to permit Investment Services Inc., Templeton Lending Funds, including a majority of certain joint transactions. Investment Counsel, LLC, Franklin the Independent Directors, (a) will Templeton Asset Strategies, LLC, determine no less frequently than APPLICANTS: Franklin Gold and Precious Fiduciary International, Inc., Franklin quarterly that all transactions with the Metal Fund, Franklin Capital Growth Templeton Investment Management Affiliated Borrowers effected during the Fund, Franklin High Income Trust, Limited, Franklin Templeton preceding quarter were effected in Franklin Custodian Funds, Inc., Investments (Asia) Limited, Franklin compliance with the requirements of the Franklin California Tax-Free Income Templeton Investments Corp., procedures adopted by the Boards and Fund, Inc., Franklin New York Tax-Free Templeton Asset Management LTD., the conditions of this order if granted Income Fund, Franklin Federal Tax-Free Templeton Global Advisors Limited, and that such transactions were Income Fund, Franklin Tax-Free Trust, Fiduciary Investment Management conducted on terms that were Franklin California Tax-Free Trust, International, Inc., Fiduciary Trust reasonable and fair; and (b) will review Franklin New York Tax-Free Trust, International Limited, FTI Institutional, no less frequently than annually such Franklin Investors Securities Trust, LLC (‘‘Advisers’’), together with any requirements and conditions for their Institutional Fiduciary Trust, Franklin entity controlling, controlled by, or continuing appropriateness. Value Investors Trust, Franklin under common control with Advisers 17. The Affiliated Lending Funds will Managed Trust, Franklin Municipal that acts in the future as investment maintain and preserve permanently in Securities Trust, Franklin Floating Rate adviser for the Franklin Templeton an easily accessible place a written copy Master Trust, Franklin Strategic Funds, the Unregistered Funds (as of the procedures (and any Mortgage Portfolio, Franklin Strategic defined below), or a Managed Account modifications thereto) which are Series, Adjustable Rate Securities (as defined below) (included in the term followed in lending securities, and shall Portfolios, Franklin Templeton ‘‘Advisers’’); the Advisers on behalf of maintain and preserve for a period of International Trust, Franklin Global certain private investment companies or not less than six years from the end of Trust, Franklin Real Estate Securities series thereof that are excluded from the the fiscal year in which any loan occurs, Trust, Franklin Templeton Global Trust, definition of ‘‘investment company’’ the first two years in an easily accessible Franklin Templeton Variable Insurance pursuant to section 3(c)(1), section place, a written record of each loan Products Trust, Franklin Universal 3(c)(7) or section 3(c)(11) of the 1940 setting forth the number of shares Trust, Franklin Multi-Income Trust, Act for which one of the Advisers

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currently or in the future serves as application. The complete application on portfolio securities, unsettled investment adviser or trustee (the may be obtained for a fee at the securities transactions, reserves held for ‘‘Unregistered Funds’’); and the Commission’s Public Reference Branch, strategic purposes, scheduled maturity Advisers on behalf of institutional and 450 Fifth Street, NW, Washington, DC of investments, liquidation of individual accounts that are not pooled 20549–0102 (telephone (202) 942–8090). investment securities to meet investment vehicles for which one of anticipated redemptions and dividend Applicants’ Representations the Advisers currently or in the future payments, and new monies received serves as investment adviser (the 1. The Franklin Templeton Funds are from investors. Certain of the Registered ‘‘Managed Accounts’’). organized as Maryland Corporations, Participating Funds have the ability to SUMMARY OF APPLICATION: The applicants California Corporations, Massachusetts increase their income by participating in request an order that would permit (a) business trusts, or Delaware statutory a securities lending program certain registered management trusts. The Franklin Templeton Funds (‘‘Securities Lending Program’’) under investment companies, Unregistered are registered under the Act as open-end which they may lend portfolio securities Funds and Managed Accounts to invest or closed-end management investment to registered broker-dealers or other uninvested cash and cash collateral in companies. The Advisers are each institutional investors deemed by the affiliated registered and unregistered registered under the Investment respective Adviser to be of good money market funds, and (b) the Advisers Act of 1940 (‘‘Advisers Act’’) standing. The loans are continuously registered investment companies and together with any entity controlling, secured by collateral which may include certain affiliated entities to continue to controlled by and under common cash (‘‘Cash Collateral,’’ together with engage in purchase and sale transactions control with Advisers that acts in the Uninvested Cash, ‘‘Cash Balances’’) involving portfolio securities in reliance future as investment adviser for the equal at all times in value to at least the on rule 17a–7 under the Act. The order Franklin Templeton Funds, an market value of the securities loaned. would supersede a prior order.1 The Unregistered Fund, as defined below, 4. Applicants request an order of the order also would amend a prior order.2 Managed Account, as defined below, Commission to permit: (i) The included in the term Advisers.3 FILING DATES: The application was filed Participating Funds to use their Cash 2. Certain of the Franklin Templeton on October 26, 2001 and amended on Balances to purchase shares of one or Funds or series thereof are money October 18, 2002, and June 10, 2003. more of the Money Market Funds; (ii) market funds subject to the the Money Market Funds to sell their HEARING OR NOTIFICATION OF HEARING: An requirements of rule 2a–7 under the Act shares to, and purchase (redeem) such order granting the application will be (‘‘Registered Money Market Funds’’). shares from, the Participating Funds; issued unless the Commission orders a The Franklin Templeton Funds or series and (iii) the Advisers to effect the above hearing. Interested persons may request thereof that are not money market funds transactions (the ‘‘Proposed a hearing by writing to the are the ‘‘Registered Funds.’’ Certain of Transactions’’). The requested order also Commission’s Secretary and serving the Unregistered Funds that rely on would permit the Participating Funds applicants with a copy of the request, section 3(c)(1) or 3(c)(7) of the Act also and the Money Market Funds to personally or by mail. Hearing requests operate as cash management vehicles continue to engage in interfund should be received by the Commission (‘‘Unregistered Money Market Funds,’’ 4 purchase and sale transactions by 5:30 p.m. on July 7, 2003, and should together with the Registered Money (‘‘Interfund Transactions’’). be accompanied by proof of service on Market Funds, the ‘‘Money Market the applicants, in the form of an Funds’’). The Unregistered Money Applicants’ Legal Analysis affidavit, or, for lawyers, a certificate of Market Funds will comply with rule 2a– I. Investment of Cash Balances by the service. Hearing requests should state 7 under the Act. Participating Funds in the Money the nature of the writer’s interest, the 3. The Registered Funds, Unregistered Market Funds reason for the request, and the issues Funds and Managed Accounts contested. Persons who wish to be (‘‘Participating Funds’’) have, or may be A. Section 12(d)(1) notified of a hearing may request expected to have, cash that has not been 1. Section 12(d)(1)(A) of the Act notification by writing to the invested in portfolio securities provides that no registered investment Commission’s Secretary. (‘‘Uninvested Cash’’).5 Uninvested Cash company may acquire securities of ADDRESSES: Secretary, Commission, 450 may result from a variety of sources, another investment company, and no Fifth Street, NW., Washington, DC including dividends or interest received investment company may inquire 20549–0609; Applicants, c/o David P. securities of a registered investment Goss, Esq., Franklin Templeton 3 All existing Advisers and Franklin Templeton company, if such securities represent Investments, One Franklin Parkway, Funds that currently intend to rely on the requested more than 3% of the acquired San Mateo, CA 94403–1906. order are named as applicants. Any other entity will not rely on the relief requested except in company’s outstanding voting stock, FOR FURTHER INFORMATION CONTACT: accordance with the terms and conditions in the more than 5% of the acquiring Deepak T. Pai, Senior Counsel, at (202) application. company’s total assets, or if such 942–0574 or Todd Kuehl, Branch Chief, 4 In addition to cash management vehicles that securities, together with the securities of at (202) 942–0564 (Division of are excluded from the definition of an investment other acquired investment companies, company pursuant to section 3(c)(1) or section Investment Management, Office of 3(c)(7) of the 1940 Act, Unregistered Money Market represent more than 10% of the Investment Company Regulation). Funds may include one or more entities that are acquiring company’s assets. Section SUPPLEMENTARY INFORMATION: The organized offshore and offer their shares privately 12(d)(1)(B) of the Act provides that no to U.S. investors (‘‘Offshore Money Market Funds,’’ registered open-end investment following is a summary of the included in the term ‘‘Unregistered Money Market Funds’’). Any Offshore Money Market Fund will company may sell its securities to 1 Franklin Gold Fund, et. al, Investment Company have as its investment adviser or trustee one of the another investment company if the sale Act Release Nos. 23633 (Jan. 5, 1999)(Notice) and Advisers. will cause the acquiring company to 23675 (Feb. 2, 1999)(Order). 5 The Participating Funds that are Registered own more than 3% of the acquired 2 Franklin Templeton Fund Manager, et. al, Funds are the ‘‘Registered Participating Funds.’’ Investment Company Act Release Nos. 21964 (May The Participating Funds that are Unregistered company’s voting stock, or if the sale 20, 1996)(Notice) and 22022(June 17, 1996)(Order) Funds and Management Accounts are the will cause more than 10% of the (the ‘‘Fund of Funds Order’’). ‘‘Unregistered Participating Funds.’’ acquired company’s voting stock to be

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owned by investment companies. Any Participating Fund will invest in the 5% of the voting securities of a Money entity that is excluded from the class with the lowest expense ratio at Market Fund, the Money Market Fund definition of investment company under the time of investment. Before the next and the Participating Fund may be section 3(c)(1) or 3(c)(7) of the Act is meeting of the board of directors or affiliated persons of each other. As a deemed to be an investment company trustees (‘‘Board’’) of the Registered result, section 17(a) would prohibit the for the purposes of the 3% limitation Participating Fund that invests in the sale of the shares of Money Market specified in sections 12(d)(1)(A) and (B) Money Market Fund is held for the Funds to the Participating Funds, and with respect to purchases by and sales purpose of voting on an advisory the redemption of the shares by the to such entity of securities of a contract under section 15 of the Act, the Participating Funds. registered investment company. Adviser will provide the Board with 2. Section 17(b) of the Act authorizes 2. Section 12(d)(1)(J) of the Act specific information regarding the the Commission to exempt a transaction provides that the Commission may approximate cost to the Adviser for, or from section 17(a) of the Act if the terms exempt any person, security, or portion of the advisory fee under the of the proposed transaction, including transaction from any provision of existing advisory contract attributable the consideration to be paid or received, section 12(d)(1) if and to the extent that to, managing the Uninvested Cash of the are reasonable and fair and do not such exemption is consistent with the Registered Participating Fund that can involve overreaching on the part of any public interest and the protection of be expected to be invested in the Money person concerned, and the proposed investors. Applicants request relief Market Fund. Before approving any transaction is consistent with the policy under section 12(d)(1)(J) to permit the advisory contract under section 15, the of each registered investment company Participating Funds to use their Cash Board of the Registered Participating concerned and with the general Balances to acquire shares of the Fund, including a majority who are not purposes of the Act. Section 6(c) of the Registered Money Market Funds in ‘‘interested persons,’’ as that term is Act permits the Commission to exempt excess of the percentage limitations in defined in section 2(a)(19) of the Act any person or transactions from any section 12(d)(1)(A), provided however, (‘‘Disinterested Directors’’), shall provision of the Act, if the exemption is that in all cases a Registered consider to what extent, if any, the necessary or appropriate in the public Participating Fund’s aggregate advisory fees charged to the Registered interest and consistent with the investment of Uninvested Cash in Participating Fund by the Adviser protection of investors and the purposes shares of the Money Market Funds will should be reduced to account for fairly intended by the policy and not exceed 25% of the Registered reduced services provided to the provisions of the Act. Participating Fund’s total assets at any Registered Participating Fund by the 3. Applicants submit that their time. Applicants also request relief to Adviser as a result of Uninvested Cash request for relief to permit the purchase permit the Registered Money Market being invested in the Money Market and redemption of shares of the Money Funds to sell their securities to the Funds. Applicants represent that no Market Funds by the Participating Participating Funds in excess of the Money Market Fund will acquire Funds satisfies the standards in sections percentage limitations in section securities of any other investment 6(c) and 17(b) of the Act. Applicants 12(d)(1)(B).6 company in excess of the limitations note that the consideration paid and 3. Applicants state that the proposed contained in section 12(d)(1)(A) of the received on the sale and redemption of arrangement will not result in the Act. shares of the Money Market Funds will be based on the net asset value per share abuses that sections 12(d)(1)(A) and (B) B. Section 17(a) of the Act were intended to prevent. Applicants of the Money Market Funds. Applicants state that because each Registered 1. Section 17(a) of the Act makes it state that the Registered Participating Money Market Fund maintains a highly unlawful for any affiliated person of a Funds will retain their ability to invest liquid portfolio and the Advisers will registered investment company, acting Cash Balances directly in money market as principal, to sell or purchase any serve as investment advisers to both the instruments and other short-term security to or from the investment Participating Funds and the Money obligations as authorized by their company. Section 2(a)(3) of the Act Market Funds, the Advisers will not be respective investment objectives and defines an affiliated person of an policies. Applicants represent that a susceptible to undue influence investment company to include any Money Market Fund reserves the right regarding their management of the person directly or indirectly owning, to discontinue selling shares to any of Registered Money Market Funds due to controlling, or holding with power to the Participating Funds if the Money threatened redemptions or loss of fees. vote 5% or more of the outstanding Market Fund’s Board determines that Applicants state that the proposed voting securities of the other person or, such sale would adversely affect the arrangement will not result in any person 5% or more of whose Money Market Fund’s portfolio inappropriate layering of fees. Shares of outstanding securities are directly or management and operations. the Money Market Funds sold to the indirectly owned, controlled, or held Participating Funds will not be subject with power to vote by such other C. Section 17(d) of the Act and Rule to a sales load, redemption fee, person, any person directly or indirectly 17d–1 Under the Act distribution fee under a plan adopted in controlling, controlled by, or under 1. Section 17(d) of the Act and rule accordance with rule 12b–1 under the common control with the other person, 17d–1 under the Act prohibit an Act or service fee (as defined in rule and any investment adviser to the affiliated person of a registered 2830(b)(9) of the Conduct Rules of the investment company. Because the investment company, acting as National Association of Securities Advisers serve, or will serve, as principal, from participating in or Dealers Inc., (a ‘‘Service Fee’’). If a investment adviser or trustee exercising effecting any transaction in connection Money Market Fund offers more than investment discretion for the with any joint enterprise or joint one class of shares, a Registered Participating Funds and Money Market arrangement in which the investment Funds, they may be deemed to be under company participates, unless the 6 Applicants also seek relief to allow the Registered Participating Funds to acquire shares of common control and therefore, affiliated Commission has approved the joint an offshore Money Market Fund in excess of the persons of each other. In addition, if a arrangement. Applicants state that the limits in section 12(d)(1)(A) of the Act. Participating Fund purchases more than Participating Funds and the Money

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Market Funds, by participating in the and fair, do not involve overreaching, 6. No Money Market Fund shall proposed transactions, and the Advisers and will be consistent with the purposes acquire securities of any investment by managing the proposed transactions, of the Act. company in excess of the limits could be deemed to be participating in contained in section 12(d)(1)(A) of the Applicants’ Conditions a joint arrangement within the meaning Act. of section 17(d) and rule 17d–1. Applicants agree that any order 7. The Unregistered Money Market 2. In considering whether to approve granting the requested relief shall be Funds will comply with the a joint transaction under rule 17d–1, the subject to the following conditions: requirements of sections 17(a), (d), and Commission considers whether the 1. The shares of the Money Market (e), and 18 of the 1940 Act. With respect investment company’s participation in Funds sold to and redeemed from the to all redemption requests made by a the joint transaction is consistent with Participating Funds will not be subject Participating Fund, the Unregistered the provisions, policies and purposes of to a sales load, redemption fee, asset- Money Market Funds will comply with the Act, and the extent to which the based distribution fee under a plan section 22(e) of the Act. The Advisers participation is on a basis different from adopted in accordance with Rule 12b– will adopt procedures designed to or less advantageous than that of other 1, or Service Fee. ensure that each Unregistered Money participants. Applicants submit that the 2. Before the next meeting of the Market Fund complies with sections Proposed Transactions meet the Board of the Registered Participating 17(a), (d), (e), 18 and 22(e) of the Act. standards for an order under rule 17d– Fund that invests in the Money Market The Advisers also will periodically 1. Fund is held for the purpose of voting review and update as appropriate the procedures, and will maintain books II. Interfund Transactions on an advisory contract pursuant to section 15 of the Act, the Adviser will and records describing such procedures, 1. Applicants state that they currently provide the Board with specific and will maintain books and records rely on rule 17a–7 under the Act to information regarding the approximate describing such procedures, and will conduct Interfund Transactions. Rule cost to the Adviser for, or portion of the maintain the records required by rules 17a–7 under the Act provides an advisory fee under the existing advisory 31a–1(b)(1), 31a–1(b)(2)(ii), and 31a– exemption from section 17(a) for a contract attributable to, managing the 1(b)(9) under the Act. All books and purchase or sale of certain securities Uninvested Cash of the Registered records required to be made pursuant to between registered investment this condition will be maintained and companies that are affiliated persons (or Participating Fund that can be expected to be invested in the Money Market preserved for a period of not less than an affiliated person of an affiliated six years from the end of the fiscal year person), or between a registered Funds. Before approving any advisory contract pursuant to section 15 of the in which any transaction occurred, the investment company, and a person that first two years in an easily accessible is an affiliated person of such company Act, the Board of the Registered Participating Fund, including a majority place, and will be subject to (or an affiliated person of such person) examination by the Commission and its of the Disinterested Directors, shall solely by reason of having a common staff. consider to what extent, if any, the investment adviser, common officers 8. Each Unregistered Money Market and/or common directors or trustees. advisory fees charged to the Registered Fund will comply with rule 2a–7. With Applicants state that the Participating Participating Fund by the Adviser respect to each Unregistered Money Funds and Money Market Funds may should be reduced to account for Market Fund, the Advisers will adopt not be able to rely on rule 17a–7 when reduced services provided to the and monitor the procedures described purchasing or selling portfolio securities Registered Participating Fund by the in rule 2a–7(c)(7) under the Act and will to each other, because some of the Adviser as a result of Uninvested Cash take such other actions as are required Participating Funds may own 5% or being invested in the Money Market to be taken under those procedures. A more of the outstanding voting Funds. The minute books of Registered Participating Fund may only purchase securities of a Money Market Fund and, Participating Fund will record fully the shares of an Unregistered Money Market therefore, an affiliation would not exist Board’s consideration in approving the Fund if the Adviser determines on an solely by reason of having a common advisory contract, including the ongoing basis that the Unregistered investment adviser, common officers considerations relating to fees referred Money Market Fund is in compliance and/or common directors or trustees. to above. with rule 2a–7. The Advisers will 2. Applicants request relief under 3. Each Registered Participating preserve for a period of not less than six sections 6(c) and 17(b) of the Act to Fund’s aggregate investment of years from the date of determination, permit the Interfund Transactions. Uninvested Cash in the Money Market the first two years in an easily accessible Applicants submit that the requested Funds will not exceed 25% of the place, a record of such determination relief satisfies the standards for relief in Registered Participating Fund’s total and the basis upon which the sections 6(c) and 17(b). Applicants state assets. For purposes of this limitation, determination was made. This record that the Funds will comply with rule each Registered Participating Fund or will be subject to examination by the 17a–7 under the Act in all respects, series thereof will be treated as a Commission and its staff. other than the requirement that the separate investment company. 9. Each Participating Fund will participants be affiliated solely by 4. Investment in shares of the Money purchase and redeem shares of any reason of having a common investment Market Funds will be in accordance Unregistered Money Market Fund as of adviser, common directors and/or with the investment policies and the same time and at the same price, and common officers. Applicants state that restrictions of each Registered will receive dividends and bear its by complying with the conditions of Participating Fund as set forth in its proportionate share of expenses on the Rule 17a–7, the interests of the registration statement. same basis, as other shareholders of the shareholders of the Registered 5. Each Registered Fund and Managed Unregistered Money Market Fund. A Participating Funds and the Registered Account that may rely on the order shall separate account will be established in Money Market Funds are protected. be advised by an Adviser. Each the shareholder records of each Thus, the Applicants submit that the Unregistered Fund shall be advised by, Unregistered Money Market Fund for Interfund Transactions are reasonable or have as its trustee, an Adviser. the account of each Participating Fund

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that invests in such Unregistered Money For the Commission, by the Division of Performance Funds Trust (‘‘Performance Market Fund. Investment Management, under delegated Funds’’), The Victory Portfolios, Vintage authority. Mutual Funds, BOk Investment 10. To engage in Interfund Margaret H. McFarland, Transactions, the Registered Funds, Advisers, Inc. (‘‘BOk’’) (formerly, Deputy Secretary. Unregistered Funds, Managed Accounts Investment Concepts, Inc.), AmSouth [FR Doc. 03–15354 Filed 6–17–03; 8:45 am] Investment Management Company, LLC and Money Market Funds will comply BILLING CODE 8010–01–P (‘‘AmSouth’’), The Bank of New York with rule 17a–7 under the Act in all (‘‘BNY’’), Citizens Advisers, Inc. respects other than the requirement that (‘‘Citizens Advisers’’), Fifth Third Asset the parties to the transaction be SECURITIES AND EXCHANGE Management, Inc. (‘‘Fifth Third’’), HSBC affiliated persons (or affiliated persons COMMISSION Asset Management (Americas) Inc. of affiliated persons) of each other solely [Investment Company Act Release No. (‘‘HSBC’’), First Financial Capital by reason of having a common 26075; 812–12779] Advisors LLC (‘‘First Financial’’), investment adviser, or investment Bessemer Investment Management LLC advisers which are affiliated persons of American Performance Funds, et al.; (‘‘Bessemer’’), Mercantile Capital each other, common officers, and/or Notice of Application Advisors, Inc. (‘‘Mercantile’’), common directors or trustees, solely Trustmark Investment Advisors, Inc. because a Participating Fund and a June 12, 2003. (formerly, Trustmark Financial Services, AGENCY: Money Market Fund might become Securities and Exchange Inc.) (‘‘Trustmark’’), Victory Capital affiliated persons within the meaning of Commission (‘‘Commission’’). Management, Inc. (‘‘Victory’’) and section 2(a)(3)(A) and (B) of the Act. ACTION: Notice of an application for an Investors Management Group, Ltd. order under section 12(d)(1)(J) of the (‘‘Investors Management Group’’). 11. The net asset value per share with Investment Company Act of 1940 (the respect to shares of an Unregistered Filing Dates: The application was ‘‘Act’’) for an exemption from sections filed on February 1, 2002 and was Money Market Fund will be determined 12(d)(1)(A) and (B) of the Act, under separately for each Unregistered Money amended on June 9, 2003. Applicants sections 6(c) and 17(b) of the Act for an have agreed to file an amendment Market Fund by dividing the value of exemption from section 17(a) of the Act, during the notice period, the substance the assets belonging to that Unregistered and under section 17(d) of the Act and of which is reflected in this notice. Money Market Fund, less the liabilities rule 17d–1 under the Act to permit HEARING OR NOTIFICATION OF HEARING: of that Unregistered Money Market certain joint transactions. An Fund, by the number of shares order granting the application will be outstanding with respect to that SUMMARY OF APPLICATION: Applicants issued unless the Commission orders a hearing. Interested persons may request Unregistered Money Market Fund. request an order that would permit certain registered management a hearing by writing to the 12. Before a Registered Participating investment companies to invest Commission’s Secretary and serving Fund may participate in the Securities uninvested cash and cash collateral in applicants with a copy of the request, Lending Program, a majority of the one or more affiliated money market personally or by mail. Hearing requests Board (including a majority of the funds in excess of the limits in sections should be received by the Commission Disinterested Directors) will approve the 12(d)(1)(A) and (B) of the Act. Prior to by 5:30 p.m. on July 7, 2003, and should Registered Participating Fund’s relying on the requested order, be accompanied by proof of service on participation in the Securities Lending Applicants would cease relying on a the applicants, in the form of an Program. No less frequently than prior order.1 affidavit, or, for lawyers, a certificate of annually, the Board also will evaluate, APPLICANTS: American Performance service. Hearing requests should state with respect to each Registered Funds, AmSouth Funds, BNY Hamilton the nature of the writer’s interest, the Participating Fund, any securities Funds, Inc. (‘‘BNY Hamilton Funds’’), reason for the request, and the issues lending arrangement and its results and Citizens Funds, Fifth Third Funds, contested. Persons who wish to be determine that any investment in Cash HSBC Advisor Funds Trust, HSBC notified of a hearing may request Collateral in the Money Market Funds is Investor Funds and HSBC Investor notification by writing to the in the best interest of the Registered Portfolios (collectively, the ‘‘HSBC Commission’s Secretary. Participating Fund. Funds’’), Legacy Funds Group (‘‘Legacy ADDRESSES: Secretary, Commission, 450 Fifth Street, NW., Washington, DC Condition 2 to the Fund-of-Funds Funds’’), Mercantile Funds, Inc. 20549–0609; Applicants, c/o Ryan M. Order is amended to read as follows: (‘‘Mercantile Funds’’), Old Westbury Funds, Inc. (‘‘Old Westbury Funds’’), Louvar, Esq., BISYS, 60 State Street, ‘‘No Underlying Portfolio will acquire Suite 1300, Boston, MA 02109. securities of any other investment 1 On February 19, 2000, the Commission issued company in excess of the limits FOR FURTHER INFORMATION CONTACT: Jean an order amending prior orders under Sections 6(c) E. Minarick, Senior Counsel, at (202) contained in section 12(d)(1)(A) of the and 17(b) of the Act that exempted certain 942–0527 or Annette M. Capretta, Act, except to the extent that the Applicants and certain other entities who are not parties to the application from the provisions of Branch Chief, at (202) 942–0564 Underlying Portfolio other than a money Section 12(d)(1)(A) and Section 17(a) of the Act and (Division of Investment Management, market fund acquires securities of that permitted pursuant to rule 17d–1, certain joint Office of Investment Company transactions in accordance with Section 17(d) and another registered or unregistered Regulation). investment company pursuant to rule 17d–1. See Investment Company Act Rel. Nos. 24274 (Feb. 1, 2000) (notice) and 24325 (Feb. 19, SUPPLEMENTARY INFORMATION: exemptive relief from the Commission 2000) (order); Investment Company Act Rel. Nos. The permitting the Underlying Portfolio to 23962 (Aug. 23, 1999) (notice) and 24021 (Sept. 21, following is a summary of the purchase securities of an affiliated 1999) (order); Investment Company Act Rel. Nos. application. The complete application 23393 (Aug. 18, 1998) (notice) and 23436 (Sept. 15, registered or unregistered money market may be obtained for a fee at the 1998); Investment Company Act Rel. Nos. 22636 Commission’s Public Reference Branch, fund for short-term cash management (April 24, 1997) (notice) and 22677 (May 20, 1997) purposes. (order); Investment Company Act Rel. Nos. 19695 450 Fifth Street, NW., Washington, DC (Sept. 9, 1993) and 19759 (Oct. 5, 1993) (order). 20549–0102 (telephone (202) 942–8090).

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Applicants’ Representations 4. Applicants request that relief be set forth in its prospectus and statement 1. American Performance Funds, extended to any registered open-end of additional information. Applicants AmSouth Funds, Citizens Funds, Fifth management investment company or believe that the proposed transactions Third Funds, HSBC Advisor Funds series thereof for which BOk, AmSouth, may reduce transaction costs, create Trust, HSBC Investor Funds, Legacy BNY, Citizen Advisers, Fifth Third, more liquidity, increase returns, and Funds and Old Westbury Funds are HSBC, First Financial, Bessemer, diversify holdings. Mercantile, Trustmark, Victory or Massachusetts business trusts that are Applicants’ Legal Analysis registered under the Act as open-end Investors Management Group (each an ‘‘Adviser,’’ and any entity controlled by, 1. Section 12(d)(1)(A) of the Act management investment companies. provides, in pertinent part, that no BNY Hamilton Funds, Mercantile Funds controlling or under common control 2 registered investment company may and Vintage Mutual Funds are Maryland with each Adviser, an ‘‘Adviser’’) now or in the future serves as investment acquire securities of another investment corporations that are registered under company if the securities represent the Act as open-end management adviser (collectively with the Funds, the ‘‘Funds’’).3 more than 3% of the acquired investment companies. HSBC Investor 5. Each Fund Group has one or more company’s outstanding voting stock, Portfolios is a New York trust that is money market Funds (‘‘Money Market more than 5% of the acquiring registered under the Act as an open-end Funds’’). The Money Market Funds company’s total assets, or if such investment management company. The comply with rule 2a–7 under the Act. securities, together with the securities of Performance Funds and The Victory The Funds that are not Money Market other acquired investment companies, Portfolios are Delaware statutory trusts Funds invest in a variety of debt and/ represent more than 10% of the that are registered under the Act as or equity securities or other investments acquired company’s total assets. Section open-end management investment in accordance with their respective 12(d)(1)(B) of the Act provides, in companies. investment objectives and policies. pertinent part, that no registered open- 2. BOk is the investment adviser to 6. Applicants state that certain Funds end investment company may sell its each of the twelve series of the (‘‘Investing Funds’’) have, or may be securities to another investment American Performance Funds. AmSouth expected to have, cash that has not been company if the sale will cause the is the investment adviser to the twenty- invested in portfolio securities acquiring company to own more than four series of the AmSouth Funds. (‘‘Uninvested Cash’’). Uninvested Cash 3% of the acquired company’s voting Citizens Advisers is the investment may result from a variety of sources, stock, or if the sale will cause more than adviser to the twelve series of the including dividends or interest received 10% of the acquired company’s voting Citizens Funds. BNY is the investment on portfolio securities, unsettled stock to be owned by investment adviser to the twenty series of BNY securities transactions, strategic companies. Hamilton Funds. Fifth Third serves as reserves, matured investments, proceeds 2. Section 12(d)(1)(J) of the Act the investment adviser to thirty-five of from liquidation of investment provides that the Commission may the thirty-six series of the Fifth Third securities, dividend payments, or exempt any person, security, or Funds. HSBC serves as investment money received from investors. The transaction from any provision of adviser to the twenty-one series of the Investing Funds may participate in a section 12(d)(1) if, and to the extent HSBC Funds. First Financial serves as securities lending program under which that, the exemption is consistent with the investment adviser to the three a Fund may lend its portfolio securities the public interest and the protection of series of the Legacy Funds. Mercantile to registered broker-dealers or other investors. Applicants request relief serves as the investment adviser to the institutional investors. The loans are under section 12(d)(1)(J) of the Act from fourteen series of the Mercantile Funds. continuously secured by collateral equal the limitations of sections 12(d)(1)(A) Bessemer serves as the investment at all times to at least the market value and (B) to permit the Investing Funds to adviser to the five series of the Old of the securities loaned. Collateral for invest Cash Balances in the Money Westbury Funds. Trustmark is the these loans may include cash (‘‘Cash Market Funds. investment adviser to the seven series of Collateral,’’ and together with 3. Applicants state that the proposed the Performance Funds. Victory is the Uninvested Cash, ‘‘Cash Balances’’). arrangement will not result in the investment adviser to the twenty-six 7. Applicants request an order to abuses that sections 12(d)(1)(A) and (B) series of The Victory Portfolios. permit each of the Investing Funds to were intended to prevent. Applicants Investors Management Group is the invest its Cash Balances in one or more state that because each Money Market investment adviser to the nine series of of the Money Market Funds within the Fund will maintain a highly liquid the Vintage Mutual Funds. same Fund Group, and to permit each portfolio, an Investing Fund would not 3. The American Performance Funds, of the Money Market Funds to sell its be in a position to gain undue influence AmSouth Funds, BNY Hamilton Funds, shares to, and redeem its shares from, over a Money Market Fund. Applicants Citizens Funds, Fifth Third Funds, the the Investing Funds within the same represent that the proposed arrangement HSBC Funds, Legacy Funds, Mercantile Fund Group. Investment of Cash will not result in an inappropriate Funds, Old Westbury Funds, Balances in shares of the Money Market layering of fees because shares of the Performance Funds, The Victory Funds will be made only to the extent Money Market Funds sold to the Portfolios and the Vintage Mutual that such investments are consistent Investing Funds will not be subject to a Funds and their respective series (each with each Investing Fund’s investment sales load, redemption fee, distribution series, a ‘‘Fund,’’ and collectively, the objectives, restrictions, and policies as fee under a plan adopted in accordance ‘‘Funds’’) each is in the American with rule 12b–1 under the Act or service Performance, AmSouth, BNY Hamilton, 2 Each Adviser is registered under the Investment fee (as defined in rule 2830(b)(9) of the Citizens, Fifth Third, HSBC, Legacy, Advisers Act of 1940 or will be exempt from National Association of Securities Mercantile, Old Westbury, Performance, registration. Dealers, Inc. (‘‘NASD’’) Conduct Rules) Victory and Vintage group of investment 3 Each Fund that currently intends to rely on the or if such shares are subject to any such order has been named as an applicant. Any other companies, respectively, within the Fund that may rely on the order in the future will sales load, redemption fees, distribution meaning of section 12(d)(1)(G)(ii) of the do so only in accordance with the terms and fees or service fees, the Adviser will Act (each a ‘‘Fund Group’’). conditions of the application. waive its advisory fee for each Investing

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Fund in an amount that offsets the of the Act permits the Commission to Money Market Funds would be amount of such fees incurred by the exempt any person or transaction from indistinguishable from any other Investing Fund. Applicants state that if any provision of the Act if such shareholder account maintained by the a Money Market Fund offers more than exemption is necessary or appropriate Money Market Fund and that the one class of shares, each Investing Fund in the public interest and consistent transactions will be consistent with the will invest only in the class with the with the protection of investors and the Act. lowest expense ratio (taking into purposes fairly intended by the policy Applicants’ Conditions account the expected impact of the and provisions of the Act. Investing Fund’s investment) at the time 6. Applicants submit that their Applicants agree that any order of the of the investment. In connection with request for relief to permit the purchase Commission granting the requested approving any advisory contract for an and redemption of shares of the Money relief will be subject to the following Investing Fund, the Investing Fund’s Market Funds by the Investing Funds conditions: board of directors/trustees (the satisfies the standards for relief under 1. Shares of the Money Market Funds ‘‘Board’’), including a majority of the sections 6(c) and 17(b) of the Act. sold to and redeemed by the Investing directors/trustees who are not Applicants note that the shares of the Funds will not be subject to a sales load, ‘‘interested persons,’’ as defined in Money Market Funds will be purchased redemption fee, distribution fee under a section 2(a)(19) of the Act and redeemed by the Investing Funds at plan adopted in accordance with rule (‘‘Disinterested Directors’’), will their net asset value, the same 12b–1 under the Act, or service fee (as consider to what extent, if any, the consideration paid and received for defined in rule 2830(b)(9) of the NASD advisory fees charged to the Investing these shares by any other shareholder. Conduct Rules), or if such shares are Fund by the Adviser should be reduced Applicants state that the Investing subject to any such fee, the Adviser for to account for the reduced services Funds will retain their ability to invest the Investing Fund will waive its provided to the Investing Fund by the Cash Balances directly in money market advisory fee for each Investing Fund in Adviser as a result of the investment of instruments as authorized by their an amount that offsets the amount of Uninvested Cash in a Money Market respective investment objectives and such fees that are incurred by the Fund. Applicants represent that no policies if they believe they can obtain Investing Fund. Money Market Fund will acquire a higher rate of return, or for any other 2. Prior to reliance on the order, an securities of any other investment reason. Applicants also state that a Investing Fund will hold a meeting of company in excess of the limitations Money Market Fund has the right to the Board for the purpose of voting on contained in section 12(d)(1)(A) of the discontinue selling shares to any of the the advisory contract under section 15 Act. Investing Funds if the Money Market of the Act. The Adviser to the Investing 4. Section 17(a) of the Act generally Fund’s Board determines that such sale Fund will provide the Board with prohibits sales or purchases of securities would adversely affect its portfolio specific information regarding the between a registered investment management and operations. approximate cost to the Adviser of, or company and an affiliated person of a 7. Section 17(d) of the Act and rule portion of the advisory fee under the registered investment company or an 17d–1 under the Act prohibit an existing advisory contract attributable affiliated person of such person acting affiliated person of a registered to, managing the Uninvested Cash of the as principal. Section 2(a)(3) of the Act investment company, acting as Investing Fund that can be expected to defines an ‘‘affiliated person’’ of another principal, from participating in or be invested in the Money Market Funds. person to include: (a) Any person effecting any transaction in connection Before approving any advisory contract directly or indirectly controlling, with any joint enterprise or joint for an Investing Fund, the Board, controlled by, or under common control arrangement in which the investment including a majority of the Disinterested with the other person; (b) any officer or company participates. Applicants state Directors, taking into account all director of such other person; and (c) if that each Investing Fund (by purchasing relevant factors, shall consider to what such other person is an investment shares of Money Market Funds), the extent, if any, the advisory fees charged company, any investment adviser Adviser for each Investing Fund (by to the Investing Fund by such Fund’s thereof. Applicants state that each Fund managing the assets of the Investing Adviser should be reduced to account within the same Fund Group may be Funds invested in Money Market for reduced services provided to the deemed to be affiliated persons of one Funds), and each Money Market Fund Investing Fund by the Adviser as a another by virtue of having a common (by selling shares to Investing Funds) result of Uninvested Cash being board of directors or common could be deemed to be participants in a invested in one or more of the Money investment advisers. In light of these joint enterprise or arrangement within Market Funds. The minute books of the possible affiliations, section 17(a) could the meaning of section 17(d) of the Act Investing Fund will record fully the prevent a Money Market Fund from and rule 17d–1 under the Act. Board’s consideration in approving the selling shares to and redeeming shares 8. Rule 17d–1 permits the advisory contract, including the from an Investing Fund. Commission to approve a proposed joint considerations relating to fees referred 5. Section 17(b) of the Act authorizes transaction covered by the terms of to above. the Commission to grant an order section 17(d) of the Act. In determining 3. Each Investing Fund will invest exempting a transaction otherwise whether to approve a transaction, the Uninvested Cash in, and hold shares of, prohibited by section 17(a) if (a) the Commission is to consider whether the Money Market Funds only to the extent terms of the proposed transaction are proposed transaction is consistent with that the Investing Fund’s aggregate fair and reasonable and do not involve the provisions, policies, and purposes of investment in such Money Market overreaching on the part of any person the Act, and the extent to which Funds does not exceed 25 percent of the concerned; (b) the proposed transaction participation by the registered Investing Fund’s total assets. For is consistent with the policies of the investment company is on a basis purposes of this limitation, each registered investment company different from, or less advantageous Investing Fund will be treated as a involved; and (c) the proposed than, that of other participants. separate investment company. transaction is consistent with the Applicants submit that the investment 4. Investment of Cash Balances in general purposes of the Act. Section 6(c) by the Investing Funds in shares of the shares of the Money Market Funds will

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be in accordance with each Investing I. Board’s Statement of the Terms of provide for including a recused Board Fund’s respective investment Substance of the Proposed Rule member in the count for quorum restrictions and will be consistent with On January 9, 2003, the Board purposes only in exigent circumstances, each Investing Fund’s policies as set adopted its bylaws. On April 25, 2003, in which the Board is required to act forth in its prospectus and statement of the Board adopted an amendment to within a limited period of time or in which the public interest or the additional information. Article VI of the bylaws to specify the protection of investors otherwise 5. Each Investing Fund that may rely powers of the Chair. In general, the prevents the deferral of action until a on the order may invest only in Money bylaws implement Title I of the quorum of non-recused members is Market Funds within the same Fund Sarbanes-Oxley Act by establishing a available. Group as the Investing Fund. principal office in Washington, DC, and 6. So long as its shares are held by an The Board’s bylaws also provide that by establishing the composition of a the Governing Board shall hold at least Investing Fund no Money Market Fund Governing Board, and the powers and shall acquire securities of any other one public meeting each month, on the duties of the Governing Board and first Tuesday of the month (the ‘‘Regular investment company in excess of the officers. The bylaws are intended by the limits contained in section 12(d)(1)(A) Public Meeting’’) or at such other time Board to be effective as of their initial as the Chair shall determine. The of the Act. adoption by a unanimous vote of the 7. Before a Fund may participate in bylaws require the Board to adopt a Board members. The Board is therefore written Open Meeting Policy defining the Securities Lending Arrangements, a proposing that the Commission approve majority of the Board, including a the circumstances under which the bylaws effective as of January 9, meetings of the Board will be open to majority of the Disinterested Directors, 2003. will approve the Fund’s participation in the public and to include in that Open the Securities Lending Arrangements. II. Board’s Statement of the Purpose of, Meeting Policy procedures to ensure Such Disinterested Directors also will and Statutory Basis for, the Proposed that the public is informed, at least five evaluate the Securities Lending Rule calendar days in advance, of the time, location, and general topics scheduled Arrangements and their results no less In its filing with the Commission, the frequently than annually and determine for discussion at each Regular Public Board included statements concerning Meeting. The bylaws also permit the that any investment of Cash Collateral the purpose of, and basis for, the in the Money Market Funds is in the Governing Board to hold additional proposed rule and discussed any meetings (‘‘Special Meetings’’), which best interest of the shareholders of the comments it received on the proposed may be public or non-public (in Fund. rule. The text of these statements may accordance with the Open Meeting For the Commission, by the Division of be examined at the places specified in Policy), as it deems necessary or Investment Management, under delegated Item IV below. The Board has prepared appropriate to further the purposes of authority. summaries, set forth in sections A, B the Sarbanes-Oxley Act. The bylaws Margaret H. McFarland, and C below, of the most significant require that the Open Meeting Policy set Deputy Secretary. aspects of such statements. forth procedures for providing the [FR Doc. 03–15356 Filed 6–17–03; 8:45 am] A. Board’s Statement of the Purpose of, public with reasonable notice of public BILLING CODE 8010–01–P and Statutory Basis for, the Proposed Special Meetings, and they permit the Rule Governing Board to meet by telephone, provided that, in the case of a public SECURITIES AND EXCHANGE The Sarbanes-Oxley Act established meeting, at least one Board member is COMMISSION the Board as a nonprofit corporation, present at the location specified in the subject to and with all the powers meeting notice. conferred upon a nonprofit corporation [Release No. 34–48027; File No. PCAOB– The bylaws provide that the Chair 2003–01] by the District of Columbia Nonprofit shall also be the President and Chief Corporation Act, to oversee the audits of Executive Officer of the Corporation and Public Company Accounting Oversight public companies that are subject to the that the other Governing Board members Board; Notice of Filing of Proposed securities laws, and related matters, in shall also be Vice Presidents of the Bylaws and Amendment No. 1 Thereto order to protect the interests of investors Corporation. Section 6.2 of the bylaws and further the public interest in the provides that the other officers of the June 13, 2003. preparation of informative, accurate, Corporation shall include a Secretary, Pursuant to section 107(b) of the and independent audit reports for Treasurer, General Counsel, Chief Sarbanes-Oxley Act of 2002 (the companies the securities of which are Auditor, Chief Administrative Officer, ‘‘Sarbanes-Oxley Act’’ or ‘‘Act’’),1 notice sold to, and held by and for, public Director of Inspections and Registration, is hereby given that on March 3, 2003, investors. Director of Investigations and the Public Company Accounting The Board’s bylaws implement Title I Enforcement, and such other officers as Oversight Board (the ‘‘Board’’ or the of the Sarbanes-Oxley Act by the Governing Board may establish in ‘‘PCAOB’’) filed with the Securities and establishing a principal office in accordance with such rules of the Board Exchange Commission (the Washington, DC, and by establishing the as may be adopted for establishing ‘‘Commission’’) the proposed rule as composition of a Governing Board, and officers. described in Items I, II, and III below, the powers and duties of the Governing Section 6.3 of the bylaws provides which items have been prepared by the Board and officers. Among the that the Chief Executive Officer is Board. On April 30, 2003, the PCAOB provisions of the bylaws are rules for responsible for, and has authority over, filed Amendment No. 1 to the proposed establishing a quorum and providing the management and administration of rule. The Commission is publishing this that an act approved by majority vote of the Corporation, including: (i) notice to solicit comments on the the members of the Governing Board Responsibility and authority for the proposed rule from interested persons. present at a meeting of the Board at appointment, dismissal, and which a quorum is present shall be an supervision of personnel (other than 1 15 U.S.C. 7217(b). act of the Board. The bylaws also Board members and personnel

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employed regularly and full-time within employees, officers, and Governing retroactively effective as of January 9, the immediate offices of the Board Board members, and any former 2003. members); (ii) the distribution of employees, officers, or Governing Board business among such personnel and members, against any and all expenses B. Board’s Statement on Burden on among organizational units of the and liabilities actually and necessarily Competition Corporation; (iii) the use and incurred by him or her, or imposed on The proposed rule does not impose expenditure of funds (including the him or her, in connection with any any burden on competition. procurement of goods and services); and claim, action, suit, or proceeding (iv) the development (for Board review) (whether actual or threatened, civil, C. Board’s Statement on Comments on of strategic policy initiatives. criminal, administrative, or the Proposed Rule Received From The bylaws also provide that in investigative, including appeals), to Members, Participants or Others carrying out any of the responsibilities which he or she may be or is made a under the provisions of section 6.3 of party by reason of being or having been The Board has not solicited, and does the bylaws, the Chief Executive Officer an employee, officer, or Board member, not intend to solicit, comments on this shall be governed by the general policies except that there shall be no proposed rule. The Board has not of the Governing Board and by such indemnification in relation to matters as received any unsolicited written rules and decisions as the Governing to which the Board finds that the comments. Board may lawfully make. The bylaws employee, officer, or Board member III. Date of Effectiveness of the also provide that the appointment by acted in bad faith or engaged in willful Proposed Rule and Timing for the Chief Executive Officer of the misconduct in the performance of a Commission Action officers of the Corporation designated in duty to the Corporation. Amounts paid and established under section 6.2 shall in indemnification of expenses and Within 35 days of the date of be subject to the approval of, and made liabilities may include, but shall not be publication of this notice in the Federal in consultation with, the Governing limited to, counsel and other related Register or within such longer period (i) Board. The bylaws also provide that the fees, costs and disbursements, and as the Commission may designate up to dismissal of the officers of the judgments, fines and penalties against, 90 days of such date if it finds such Corporation designated in and and amounts paid in settlement by, such longer period to be appropriate and established under section 6.2 shall be employee, officer, or Board member. publishes its reasons for so finding or made in consultation with the The bylaws further permit the (ii) as to which the Board consents the Governing Board, except that when the Corporation to advance expenses to, or Commission will: Board determines that the dismissal where appropriate to itself, at its arises out of a conflict regarding the expense, undertake the defense of any (a) by order approve such proposed general policies of the Governing Board, employee, officer, or Board member, so rule; or it is also subject to the approval of the long as the employee, officer, or Board (b) institute proceedings to determine Governing Board. member undertakes to repay or whether the proposed rule should be The bylaws also provide that each reimburse such expense if it should be disapproved. Board member has the responsibility ultimately determined that he or she is and authority for the appointment, not entitled to indemnification under IV. Solicitation of Comments dismissal, and supervision of personnel the bylaws. Interested persons are invited to employed regularly and full-time within The bylaws also permit the Governing submit written data, views and the immediate office of the Board Board to purchase insurance on behalf member. The Board member’s of any employee, officer, or Governing arguments concerning the foregoing, responsibility and authority for these Board member against any liability including whether the proposed rule is persons would be subject to the which may be asserted against or consistent with the requirements of Governing Board’s overall personnel incurred by him or her which arises out Title I of the Sarbanes-Oxley Act and policies. of such person’s status as an employee, the Exchange Act. Persons making The bylaws also provide that the officer, or Board member, whether or written submissions should file six Chief Executive Officer has the not the Corporation would have the copies thereof with the Secretary, responsibility and authority to develop, power to indemnify such person against Securities and Exchange Commission, and present to the Board for approval, that liability under law. 450 Fifth Street, NW., Washington, DC an annual budget as well as mid-year The bylaws permit the Governing 20549–0609. Copies of the submission, adjustments, if any. The bylaws further Board to adopt such rules of the all subsequent amendments, all written provide that there is reserved to the Corporation as it deems necessary or statements with respect to the proposed Governing Board its responsibility and appropriate to discharge its rule that are filed with the Commission, authority with respect to determining responsibilities under the Sarbanes- and all written communications relating the distribution of funds according to Oxley Act. The bylaws also prohibit any to the proposed rule change between the major programs and purposes, including capital expenditure or investment Commission and any person, other than those related to salary schedules and without the approval of the Board, those that may be withheld from the other conditions of employment. except as expressly delegated by the public in accordance with the The bylaws also provide that no Governing Board. Finally, the bylaws provisions of 5 U.S.C. 552, will be contract entered into by or on behalf of require the Governing Board to retain an available for inspection and copying in the Corporation shall personally accounting firm to annually audit the the Commission’s Public Reference obligate any employee, officer, or Corporation’s financial records, which Room in Washington, DC. Copies of Governing Board member, including the firm shall not perform any other such filing will also be available for employee, officer or Governing Board services, except tax services, for the inspection and copying at the principal member authorizing or executing such a Corporation. office of the PCAOB. All submissions contract. Further, unless otherwise In the event that the Commission should refer to File No. SR–PCAOB– prohibited by law, the bylaws provide approves the Board’s bylaws, the Board 2003–01 and should be submitted by for the Corporation to indemnify seeks that they be approved so as to be July 9, 2003.

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By the Commission. the maintenance of a fair and orderly options traders and options specialists.3 Margaret H. McFarland, market and shall engage, to a reasonable Subparagraph (c)(i) of Rule 958 requires Deputy Secretary. degree under the existing registered options traders and options [FR Doc. 03–15355 Filed 6–17–03; 8:45 am] circumstances, in dealings for his own specialists, in the course of maintaining BILLING CODE 8010–01–P account when there exists a lack of price a fair and orderly market, to adhere to continuity, a temporary disparity maximum bid/offer differentials between the supply of and demand for specified in the rule.4 In connection SECURITIES AND EXCHANGE option contracts of a particular series, or with this conversion from fractions to COMMISSION a temporary distortion of the price decimals, the Exchange converted (i) the relationships between option contracts [Release No. 34–48023; File No. SR–Amex– maximum bid/offer differential of 3/8 of 2003–53] of the same class. Without limiting the $1 to $0.37 where the prevailing bid is foregoing, a Registered Trader is at or above $2 but does not exceed $5; Self-Regulatory Organizations; Notice expected to perform the following and (ii) the maximum bid/offer of Filing and Immediate Effectiveness activities in the course of maintaining a differential of 3/4 of $1 to $0.75 where of Proposed Rule Change by the fair and orderly market: the prevailing bid is more than $10 but American Stock Exchange LLC (i) If the underlying security is a stock does not exceed $20. Relating to Maximum Bid/Offer or Exchange-Traded Fund Share, The requirements of related Exchange Differentials for Option Contracts bidding and offering so as to create Rule 952, however, created anomalies in June 12, 2003. differences of no more than $0.25 the maximum bid/offer differentials as between the bid and the offer for each Pursuant to section 19(b)(1) of the stated in Rule 958. Amex Rule 952, option contract for which the prevailing Securities Exchange Act of 1934 which sets forth the minimum price (‘‘Act’’)1 and Rule 19b–4 thereunder,2 bid is less than $2, no more than [$0.37] variation (‘‘MPV’’) for option contracts, notice is hereby given that on June 2, $0.40 where the prevailing bid is $2 but requires a MPV of $0.05 where an 2003, the American Stock Exchange LLC does not exceed $5, no more than $0.50 option contract trades less than $3.00 where the prevailing bid is more than $5 (the ‘‘Amex’’ or the ‘‘Exchange’’) filed and a MPV of $0.10 where an option but does not exceed $10, no more than with the Securities and Exchange contract trades at or above $3. [$0.75] $0.80 where the prevailing bid is Commission (the ‘‘Commission’’) the Consequently, option contracts trading more than $10 but does not exceed $20, proposed rule change as described in at or above $2 but less than $3 are and no more than $1 where the last Items I and II below, which Items have restricted to a maximum bid/offer prevailing bid is more than $20. In the been prepared by the Exchange. The differential of $0.35, not $0.37, because event the bid/ask differential in the Commission is publishing this notice to the MPV at those prices is $0.05, and underlying security is greater than the solicit comments on the proposed rule option contracts trading at or above $3 bid/ask differential set forth herein, the change from interested persons. but not exceeding $5 are restricted to a permissible price differential for any in- maximum bid/offer differential of $0.30, I. Self-Regulatory Organization’s the-money option series may be not $0.37, because the MPV at those Statement of the Terms of Substance of identical to those in the underlying prices is $0.10. Similarly, option the Proposed Rule Change security market. contracts where the prevailing bid is The Amex proposes to amend II. Self-Regulatory Organization’s more than $10 but does not exceed $20 Exchange Rule 958 to set the maximum Statement of the Purpose of, and are allowed a maximum bid/offer bid/offer differential for option contracts Statutory Basis for, the Proposed Rule differential of $0.75 under Amex Rule at $0.40 where the prevailing bid is at Change 958, but since the MPV is $0.10 at those or above $2 but does not exceed $5, and prices, registered options traders and $0.80 where the prevailing bid is more In its filing with the Commission, the options specialists are required to quote than $10 but does not exceed $20. The Amex included statements concerning with a maximum differential of $0.70. text of the proposed rule change is set the purpose of and basis for the forth below. [Bracketing] indicates text proposed rule change and discussed any Because maximum bid/offer to be deleted, and italics indicates text comments it received on the proposed differentials were reduced from levels to be added. rule change. The text of these statements permitted before the conversion from * * * * * may be examined at the places specified fractions to decimals, the Exchange now in Item IV below. The Amex has proposes to amend Amex Rule 958 to Options Transactions of Registered prepared summaries, set forth in increase the maximum bid/offer Traders Sections A, B, and C below, of the most differential (i) from $0.37 to $0.40 where Rule 958 significant aspects of such statements. the prevailing bid is at or above $2 but does not exceed $5; and (ii) from $.075 (a)–(b) No change A. Self-Regulatory Organization’s to $0.80 where the prevailing bid is (c) With respect to each class of Statement of the Purpose of, and the more than $10 but does not exceed $20. options as to which he is assigned by Statutory Basis for, the Proposed Rule These changes will conform Amex Rule the Exchange, a Registered Trader, Change whenever he enters the trading crowd in 958 to the Exchange’s current practice of other than a floor brokerage capacity, or (1) Purpose allowing registered options traders and is called upon by a Floor Official or a options specialists to quote bids and Floor Broker acting in an agency Pursuant to the industry-wide offers with maximum bid/offer capacity, is required to make conversion of the pricing of securities competitive bids and offers as from fractions to decimals, the Exchange 3 Exchange Rule 950(n) requires options reasonably necessary to contribute to converted all stocks and options pricing specialists to adhere to the maximum bid/offer in its rules to decimals. Among the rules differentials set forth in Amex Rule 958(c). 4 The maximum bid/offer differential varies 1 15 U.S.C. 78s(b)(1). affected was Exchange Rule 958, which depending upon the prevailing bid for the option 2 17 CFR 240 19b–4. sets forth the obligations of registered contract.

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differentials of $0.40 and $0.80 under investors and the public interest. SECURITIES AND EXCHANGE the abovementioned conditions.5 Acceleration of the operative delay will COMMISSION (2) Basis permit the Amex to amend Rule 958 [Release No. 34–48024; File No. SR–Amex– without undue delay. For this reason, 2003–36] The proposed rule change is the Commission designates the proposal 6 consistent with section 6(b) of the Act to be effective upon filing with the Self-Regulatory Organizations; Notice in general and furthers the objectives of Commission.10 At any time within sixty of Filing and Order Granting section 6(b)(5) of the Act 7 in particular (60) days of the filing of the proposed Accelerated Approval of a Proposed in that it is designed to prevent rule change, the Commission may Rule Change and Amendments No. 1 fraudulent and manipulative acts and and 2 by the American Stock Exchange practices, to promote just and equitable summarily abrogate such rule change if it appears to the Commission that such LLC To Initiate a Pilot Program That principles of trade, to foster cooperation Allows the Listing of Strike Prices at and coordination with persons engaged action is necessary or appropriate in the public interest, for the protection of One-Point Intervals for Certain Stocks in facilitating transactions in securities, Trading Under $20 and to remove impediments to and investors, or otherwise in furtherance of perfect the mechanism of a free and the purposes of the Act. June 12, 2003. open market and a national market IV. Solicitation of Comments Pursuant to section 19(b)(1) of the system. Securities Exchange Act of 1934 (‘‘Act’’),1 and Rule 19b–4 thereunder,2 B. Self-Regulatory Organization’s Interested persons are invited to notice is hereby given that on April 29, Statement on Burden on Competition submit written data, views and arguments concerning the foregoing, 2003, the American Stock Exchange LLC The Exchange does not believe that including whether the proposed rule (‘‘Amex’’ or ‘‘Exchange’’) filed with the the proposed rule change will impose change is consistent with the Act. Securities and Exchange Commission any burden on competition. Persons making written submissions (‘‘SEC’’ or ‘‘Commission’’) the proposed C. Self-Regulatory Organization’s should file six copies thereof with the rule change as described in Items I and Statement on Comments on the Secretary, Securities and Exchange II below, which Items have been Proposed Rule Change Received From Commission, 450 Fifth Street, NW., prepared by the Exchange. The Exchange filed Amendments No. 1 and Members, Participants or Others Washington, DC 20549. Copies of the 2 to the proposal on June 3, 2003,3 and submission, all subsequent No written comments were solicited June 11, 2003,4 respectively. The or received with respect to the proposed amendments, all written statements Commission is publishing this notice to rule change. with respect to the proposed rule solicit comments on the proposed rule III. Date of Effectiveness of the change that are filed with the change, as amended, from interested Proposed Rule Change and Timing for Commission, and all written persons and to grant accelerated Commission Action communications relating to the approval to the proposed rule change, as proposed rule change between the amended, through June 5, 2004. The foregoing rule change has become Commission and any person, other than immediately effective pursuant to those that may be withheld from the I. Self-Regulatory Organization’s section 19(b)(3)(A) of the Act 8 and Rule public in accordance with the Statement of the Terms of Substance of 19b–4(f)(6) 9 thereunder because (i) it provisions of 5 U.S.C. 552, will be the Proposed Rule Change does not significantly affect the The Exchange proposes to initiate a protection of investors or the public available for inspection and copying in the Commission’s Public Reference pilot program (‘‘Pilot Program’’) that interest; (ii) it does not impose any will allow the Exchange to list options significant burden on competition; and Section, 450 Fifth Street, NW., Washington, DC 20549. Copies of such on selected stocks trading below $20 at (iii) by its terms, it does not become one-point intervals. The text of the operative for 30 days after the date of filing will also be available for inspection and copying at the principal proposed rule change appears below. the filing, or such shorter time as the Additions are in italics. Commission may designate if consistent office of the Amex. All submissions with the protection of investors and the should refer to File No. SR–Amex– Rule 903. Series of Options Open for public interest; provided that the self- 2003–53 and should be submitted by Trading regulatory organization has given the July 9, 2003. (a)–(d) No Change. Commission written notice of its intent For the Commission, by the Division of Commentary to file the proposed rule change, along Market Regulation, pursuant to delegated with a brief description and text of the authority.11 .01–.03 No Change. proposed rule change, at least five Margaret H. McFarland, business days prior to the date of filing 1 15 U.S.C. 78s(b)(1). of the proposed rule change. Deputy Secretary. 2 17 CFR 240.19b–4. The Exchange has requested that the [FR Doc. 03–15352 Filed 6–17–03; 8:45 am] 3 Amendment No. 1 replaces and supersedes the original filing in its entirety. Commission waive the 30-day operative BILLING CODE 8010–01–P 4 See letter from Jeffrey P. Burns, Associate delay. The Commission believes General Counsel, Amex, to Nancy Sanow, Division waiving the 30-day operative delay is of Market Regulation, Commission, dated June 10, consistent with the protection of 2003 (‘‘Amendment No. 2’’). Amendment No. 2 revises the proposal to indicate that: (1) The pilot program will expire on June 5, 2004; (2) the strike 5 Under Amex Rule 958(c)(i), the Exchange may price interval for options on individual stocks will establish, where appropriate, maximum bid/offer 10 For purposes only of accelerating the operative be $5 or greater where the strike price is greater differentials other than those set forth in the rule. date of this proposal, the Commission has than $25 but less than $200 and $10 or greater 6 15 U.S.C. 78f(b). considered the proposed rule’s impact on where the strike price is greater than or equal to 7 15 U.S.C. 78f(b)(5). efficiency, competition, and capital formation. 15 $200; and (3) the strike price interval for options on 8 15 U.S.C. 78s(b)(3)(A). U.S.C. 78c(f). Exchange-Traded Fund Shares (‘‘ETFs’’) will be $5 9 17 CFR 240.19b–4(f)(6). 11 17 CFR 200.30–3(a)(12). or greater where the strike price is over $200.

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.04 The interval between strike .06 The options exchanges may to amend Amex Rule 903 to indicate prices of series of options on individual select up to 200 options classes on that: (1) the strike price interval for stocks may be (a) $2.50 or greater where individual stocks for which the interval series of options on individual stocks the strike price is $25 or less, provided of strike prices will be $2.50 where the may be $2.50 or greater where the strike however, that the Exchange may not list strike price is greater than $25 but less price is $25 or less,6 $5 or greater where $2.50 intervals below $20 (e.g. $12.50, than $50. The 200 options classes are the strike price is greater than $25 but $17.50) for any class included within selected by the various options less than $200 (except for options the $1 Strike Price Pilot Program, as exchanges pursuant to any agreement included in the options exchanges’ $2 detailed below in Commentary .05, if the mutually agreed to by the individual 1⁄2-point strike price program, as addition of $2.50 intervals would cause exchanges and approved by the described below), or $10 or greater the class to have strike price intervals Commission. In addition to those where the strike price is greater than or that are $0.50 apart; (b) $5 or greater options selected by the Exchange, the equal to $200; and (2) the strike price where the strike price is greater than $25 strike price interval may be $2.50 in any interval for series of options on ETFs but less than $200; or (c) $10 or greater multiply-traded option once another may be $1 or greater where the strike where the strike price is greater than or exchange trading that option selects price is $200 or less or $5 or greater equal to $200. For series of options on such option, as part of this program. where the strike price is over $200. In Exchange-Traded Fund Shares that The Exchange and any of the other addition, the Amex proposes to revise satisfy the criteria set forth in options exchanges may also list strike Amex Rule 903 to describe more Commentary .06 to Rule 915, the prices of $2.50 on any option class that specifically the options exchanges’ 21⁄2- interval of strike prices may be $1 or was selected by the NYSE pursuant to point strike price program.7 greater where the strike price is $200 or this program. less or $5 or greater where the strike Pilot Program price is over $200. Exceptions to the II. Self-Regulatory Organization’s The Amex notes that stock prices in strike price intervals above are set forth Statement of the Purpose of, and general have dropped over the past few in Commentaries .05 and .06 below. Statutory Basis for, the Proposed Rule years, with many listings suffering .05 The interval between strike Change severe declines. As a result, there has prices of series of options on individual In its filing with the Commission, the been a proliferation of stocks trading stocks may be: Exchange included statements below $20. The Amex lists options on a. $1.00 or greater (‘‘$1 Strike Prices’’) concerning the purpose of and basis for more than 900 of these stocks. Some of provided the strike price is $20 or less, the proposed rule change and discussed these stocks are among the most widely but not less than $3. The listing of $1 any comments it received on the held and actively traded equity strike prices shall be limited to option proposed rule change. The text of these securities listed on the New York Stock classes overlying no more than five (5) statements may be examined at the Exchange, Inc., the Amex, and Nasdaq, individual stocks (the ‘‘$1 Strike Price places specified in Item III below. The including, for example, Cisco, Oracle, Pilot Program’’) as specifically Exchange has prepared summaries, set Lucent, JDS Uniphase, AT&T, and designated by the Exchange. The forth in sections A, B, and C below, of Motorola. Accordingly, the options Exchange may list $1 Strike Prices on the most significant aspects of such overlying these stocks are among the any other option classes if those classes statements. most actively traded options. are specifically designated by other When a stock underlying an option A. Self-Regulatory Organization’s national securities exchanges that trades at a lower price, it requires a Statement of the Purpose of, and employ a similar $1 Strike Price Pilot larger percentage gain in the price of the Statutory Basis for, the Proposed Rule Program under their respective rules. stock for an option to become in-the- b. To be eligible for inclusion into the Change money. For example, when a stock $1 Strike Price Pilot Program, an 1. Purpose trades at $10 an investor that wants to underlying security must close below $20 in the primary market on the The Amex proposes to amend Amex purchase a slightly out-of-the-money previous trading day. After a security is Rule 903, ‘‘Series of Options Open for call option would have to buy the added to the $1 Strike Price Pilot Trading,’’ to implement the Pilot $12.50 call. At these levels, the stock Program, the Exchange may list $1 Program, which will operate until June (January 16, 1985) (File No. SR–Amex–84–31) Strike Prices from $3 to $20 that are no 5, 2004. The Pilot Program will allow (order approving $5 strike price intervals for more than $5 from the closing price of the Amex to list options on up to five options on stocks trading below $200); and 40157 the underlying on the preceding day. underlying equities trading below $20 at (July 1, 1998), 63 FR 37426 ((July 10, 1998) (File No. For example, if the underlying security one-point intervals and to list $1 strike SR–Amex–96–44) (order approving strike price intervals of $1 or greater for options on ETFs up to closes at $13, the Exchange may list prices on any equity option included in a strike price of $200 and strike price intervals of strike prices from $8 to $18. The the $1 strike price pilot program of any $5 or greater for ETF options where the strike price Exchange may not list series with $1 other options exchange. is over $200). intervals within $0.50 of an existing In addition to implementing the Pilot 6 As discussed more fully below, the Pilot $2.50 strike price (e.g. $12.50, $17.50) in Program, the Amex proposes to amend Program will impose certain limitations on the Amex’s ability to list $21⁄2-point strike prices on the same series. Additionally, for an Amex Rule 903 to codify certain options included in the Pilot Program. option class selected for the $1 Strike existing strike price interval guidelines 7 See Securities Exchange Act Release No. 40662 Price Pilot Program, the Exchange may that the Commission approved but that (November 12, 1998), 63 FR 64297 (November 19, not list $1 Strike Prices on any series have not been codified in Amex Rule 1998) (File Nos. SR–Amex–98–21; SR–CBOE–98– 5 29; SR–PCX–98–31; and SR–PHLX–98–26) (order having greater than nine (9) months 1 903. In this regard, the Amex proposes permanently approving the 2 ⁄2-point strike price until expiration. pilot program). The 21⁄2-point strike price program c. A security shall remain in the $1 5 See Securities Exchange Act Release Nos. 21929 allows the Amex, the Chicago Board Options Strike Price Pilot Program until (April 10, 1985), 50 FR 15258 (April 17, 1985) (File Exchange, Inc. (‘‘CBOE’’), the Pacific Exchange, No. SR–Amex–85–6) (order approving $2.50 strike Inc., and the Philadelphia Stock Exchange, Inc. to otherwise designated by the Exchange. price intervals for options on individual stocks list up to 200 equity options trading at a strike price The $1 Strike Price Pilot Program shall where the strike price is $25 or less) (‘‘April 1985 greater than $25 but less than $50 at 21⁄2-point expire on June 5, 2004. Order’’); 21644 (January 9, 1985), 50 FR 2360 intervals.

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price would need to increase by 25% to add strike prices outside of the $5 range. class upon the initial listing of an reach in-the-money status. According to For example, if the underlying stock options class for trading. Thus, for the Amex, a 25% or higher gain in the trades at $6, the Exchange could list $1 options included in the Pilot Program, price of the underlying stock is strike prices from $3 to $11, while if the the Amex will list an additional especially large given the lessened underlying stock trades at $10, the expiration month upon expiration of the degree of volatility that has Exchange could list $1 strikes from $5 near-term month, provided that the accompanied many stocks and options to $15. By restricting the number of underlying stock prices closes below over the past several months. strike prices that may be listed to a $20 on Expiration Friday. If the Accordingly, Amex member firms have predetermined $5 range, the Exchange underlying closes at or above $20 on its expressed an interest in listing believes it will be able to provide primary market on Expiration Friday, additional strike prices on these classes investors with more flexibility without the Exchange will not list an additional so that they can provide their customers burdening The Options Price Reporting month of $1 strike price series until the with greater flexibility in achieving their Authority (‘‘OPRA’’) capacity by stock again closes below $20. investment strategies. For this reason, bringing up strike prices that are not 6. Procedures for Delisting $1 Strike the Exchange proposes to implement the reasonably related to the price of the Price Intervals: At any time, the proposed Pilot Program. underlying stock. Exchange may cease listing $1 strike 1. Pilot Program Eligibility: The Currently, when an underlying stock prices on existing series by submitting Exchange proposes to amend Amex trades below $25, the Exchange may list a cessation notice to The Options Rule 903 to allow the Exchange to list strike prices with $2.50 intervals.8 For Clearing Corporation (‘‘OCC’’).9 As options on selected stocks trading below this reason, several classes have $7.50, discussed above, if the underlying $20 at one-point intervals, provided that $12.50, and $17.50 strike prices. To closes at or above $20 on its primary the strike prices are $20 or less, but not further avoid the proliferation of series, market on Expiration Friday, the Amex less than $3. An option would become the Exchange does not intend to list $1 will not list any additional months with eligible for inclusion in the Pilot strike prices at levels that ‘‘bracket’’ $1 strike prices until the stock Program provided that the underlying existing $2.50 intervals (e.g., $7 and $8 subsequently closes below $20. If the stock closed below $20 in its primary strikes around a $7.50 strike). underlying stock does not subsequently market on the preceding trading day. Accordingly, the Exchange does not close below $20, thereby precluding the Once the underlying stock is part of the intend to list $7, $8, $12, $13, $17, and listing of additional strike prices and Pilot Program, the Exchange may $18 levels in an expiration month where months, the existing $1 series continue to list $1 strike prices provided there is a corresponding $2.50 level. As eventually will expire. When the near- the underlying stock remains below $20. the $2.50 intervals are ‘‘phased-out,’’ as term month is the only series available As described more fully below, although described below, the Exchange will for trading, the Exchange may submit a an option class will not be removed introduce the $1 levels that bracket the cessation notice to OCC. Upon automatically from the Pilot Program if phased-out price. For example, when a submission of that notice, the the underlying stock trades at or above $7.50 series expires, the Exchange will underlying stock would no longer count $20, the Amex will not add $1 strike replace it by issuing a new expiration towards the five option classes available prices when the underlying stock closes month with $7 and $8 strike price on the Exchange pursuant to the Pilot above $20. Once the stock closes below intervals. Program, thereby allowing the Exchange 3. Procedures for Phasing-Out $2.50 $20, it will again be eligible for the to list options on an additional stock at addition of $1 strike prices. An Strike Price Intervals: When an $1 strike price intervals. Once the underlying stock will remain in the individual stock becomes a part of the Exchange submits the cessation notice it Pilot Program until the Amex removes Pilot Program, the Exchange will begin will not list any additional months it from the Pilot Program. Options on to phase-out the existing $2.50 strike pursuant to the Pilot Program for trading stocks trading under $20 that are not price intervals for options on that stock with strikes below $20, unless the included in the Pilot Program may in favor of the $1 strike price intervals. underlying stock again closes below continue to trade in $2.50 and $5.00 To phase-out the $2.50 strike price $20.10 strike price intervals. Although the intervals, the Exchange first will delist 7. OPRA Capacity: The Exchange Amex may only select up to five any $2.50 series for which there is no believes that OPRA has the capacity to individual stock options for its Pilot open interest. Second, the Exchange Program, the Exchange will not be will no longer add new expiration accommodate the increase in the precluded from also listing at $1 strike months at $2.50 strike price intervals number of series that could be added price intervals equity options included below $20 when existing months expire. pursuant to the Pilot Program. In this in the $1 strike price programs of other This will cause the $2.50 strike price regard, the Amex notes that, on a daily option exchanges. intervals below $20 to be phased-out basis, the options exchanges use an 2. Procedure for Adding $1 Strike when the farthest-out month with a average of less than 7,000 messages per Price Intervals: The Exchange proposes $2.50 interval expires. second (‘‘mps’’) during peak periods, to amend Amex Rule 903 to set forth the 4. $1 Strikes for Longer Dated 9 The reasons for submitting a cessation notice are standards regarding the addition of $1 Options: The Exchange will not list $1 as follows: (1) Expiration of available $1 strikes (i.e. strike price intervals. Under the Pilot strikes on any series of individual the underlying stock price remains at or above $20); Program, the closing price of the equity option classes that have greater (2) series proliferation concerns; and (3) delisting underlying stock serves as the reference than nine months until expiration. because of, among other things, low price, merger, point for determining which $1 strike 5. Procedures for Adding Expiration or takeover. In any event, with prior notice to the membership and customers, the Amex will prices the Exchange may open for Months: Amex Rule 903(a)(i) will continue to have the ability to cease trading any trading. To minimize the proliferation of govern the addition of expiration series that has became inactive and has no open options series, the Exchange intends to months for $1 strikes series. Pursuant to interest. restrict the number of $1 strike prices this rule, the Exchange generally opens 10 If the underlying stock trades below $20 after the Amex submits a cessation notice, the Amex that may be added to those strikes that up to four expiration months for each could again list options on that stock at $1 strike fall within a $5 range of the price of the prices provided the Amex included the class as one underlying stock. The Amex will not 8 See April 1985 Order, supra note 5. of its five allowable classes.

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which is less than 25% of the total subsequent amendments, all written remedy this situation should it occur. In system capacity of 32,000 mps. statements with respect to the proposed addition, the Commission requests that According to the Amex, the Amex listed rule change that are filed with the the Amex monitor the trading volume approximately 108,094 series in Commission, and all written associated with the additional options December 2000, approximately 100,632 communications relating to the series listed as a result of the Pilot series in September 2001, and proposed rule change between the Program and the effect of these approximately 88,494 series in April Commission and any person, other than additional series on market 2003. The Amex believes that the those that may be withheld from the fragmentation and on the capacity of the increase in the number of series public in accordance with the Exchange’s, OPRA’s, and vendors’ resulting from the Pilot Program should provisions of 5 U.S.C. 552, will be automated systems. be substantially less than the decreases available for inspection and copying in As noted above, the Commission is in listed series experienced by the the Commission’s Public Reference approving the Amex’s proposal on a Exchange. Room. Copies of such filings will also be pilot basis. In the event that Amex Furthermore, the Amex states that, to available for inspection and copying at proposes to extend the Pilot Program date, the options exchanges have not the principal office of the Exchange. All beyond June 5, 2004, expand the exceeded 11,000 mps for any extended submissions should refer to File No. number of options eligible for inclusion period of time.11 Therefore, the Amex SR–Amex–2003–36 and should be in the Pilot Program, or seek permanent believes that implementing the Pilot submitted by July 9, 2003. approval of the Pilot Program, it should Program would not have a negative submit a Pilot Program report to the IV. Commission’s Findings and Order impact on OPRA system capacity. Commission along with the filing of Granting Accelerated Approval of such proposal.16 The report must cover 2. Statutory Basis Proposed Rule Change the entire time the Pilot Program was in The Exchange believes the proposed After careful review, the Commission effect, and must include: (1) Data and rule change is consistent with section finds that the proposed rule change is written analysis on the open interest 12 6(b) of the Act in general and furthers consistent with the requirements of the and trading volume for options (at all 13 the objectives of section 6(b)(5), in Act and the rules and regulations strike price intervals) selected for the particular, in that it is designed to thereunder applicable to a national Pilot Program; (2) delisted options series prevent fraudulent and manipulative securities exchange.14 In particular, the (for all strike price intervals) for all acts and practices, to promote just and Commission finds that the proposed options selected for the Pilot Program; equitable principles of change, to foster rule change is consistent with section (3) an assessment of the appropriateness cooperation and coordination with 6(b)(5) of the Act,15 which requires, of $1 strike price intervals for the persons engaged in facilitating among other things, that the rules of a options the Amex selected for the Pilot transactions in securities, and to remove national securities exchange be Program; (4) an assessment of the impediments to and perfect the designed to remove impediments to and impact of the Pilot Program on the mechanism of a free and open market perfect the mechanism of a free and capacity of the Amex’s, OPRA’s, and and a national market system. open market and a national market vendors’ automated systems; (5) any B. Self-Regulatory Organization’s system, and, in general, to protect capacity problems or other problems Statement on Burden on Competition investors and the public interest. that arose during the operation of the Specifically, the Commission believes Pilot Program and how the Amex The Exchange believes that the that the proposed listing of one point addressed them; (6) any complaints that proposed rule change will impose no strike price intervals in selected equity the Amex received during the operation burden on competition. options on a pilot basis should provide of the Pilot Program and how the Amex C. Self-Regulatory Organization’s investors with more flexibility in the addressed them; and (7) any additional Statement on Comments on the trading of equity options overlying information that would help to assess Proposed Rule Change Received From stocks trading at more than $3 but less the operation of the Pilot Program. Members, Participants, or Others than $20, thereby furthering the public The Commission believes that the No written comments were solicited interest by allowing investors to proposal to codify previously approved or received with respect to the proposed establish equity options positions that options strike price interval guidelines rule change. are better tailored to meet their in Amex Rule 903 and to revise Amex investment objectives. The Commission Rule 903 to describe the options’ III. Solicitation of Comments also believes that the Exchange’s limited exchanges existing 21⁄2-point strike Interested persons are invited to Pilot Program strikes a reasonable price program with greater specificity submit written data, views, and balance between the Exchange’s desire should help to clarify the Amex’s rules arguments concerning the foregoing, to accommodate market participants by and facilitate compliance with them, including whether the proposed rule offering a wide array of investment thereby protecting investors and the change, as amended, is consistent with opportunities and the need to avoid public interest. the Act. Persons making written unnecessary proliferation of options The Commission finds good cause for submissions should file six copies series. The Commission expects the approving the proposal, as amended, thereof with the Secretary, Securities Exchange to monitor the applicable prior to the thirtieth day after the date and Exchange Commission, 450 Fifth equity options activity closely to detect of publication of notice of filing thereof Street, NW., Washington, DC 20549– any proliferation of illiquid options in the Federal Register. The Amex’s 0609. Copies of the submission, all series resulting from the narrower strike Pilot Program is identical to a CBOE price intervals and to act promptly to pilot program (‘‘CBOE Pilot’’) that the 11 According to the Amex, on November 6, 2002, the OPRA five-minute message peak was 8,203 mps 14 In approving this proposed rule change, the 16 The Commission expects the Amex to submit and on November 13, 2002, the one-minute peak Commission has considered the proposed rule’s a proposed rule change at least 60 days before the was 10,091 mps. impact on efficiency, competition, and capital expiration of the Pilot Program in the event the 12 15 U.S.C. 78f(b). formation. 15 U.S.C. 78c(f). Amex wishes to extend, expand, or seek permanent 13 15 U.S.C. 78f(b)(5). 15 15 U.S.C. 78f(b)(5). approval of the Pilot Program.

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Commission approved.17 Notice of the II below, which Items have been Auto-Ex Incentive Program for CBOE Pilot was published for prepared by the Exchange. On June 6, apportioning Auto-Ex trades among comment 18 and the Commission 2003, the Exchange filed Amendment Market Makers.5 On June 7, 2002, the received one comment letter, which No. 1 to the proposed rule change.3 The Commission extended the Auto-Ex supported the CBOE’s proposal. Commission is publishing this notice to Incentive Program pilot for six months 6 Accordingly, the Commission believes solicit comments on the proposed rule and on December 24, 2002, the that the Amex’s Pilot Program raises no change from interested persons and is Commission extended the pilot for an issues of regulatory concern. approving the proposal on an additional six months.7 The pilot Amendment No. 2 clarifies the proposal accelerated basis. program is currently set to expire on by specifying the expiration date for the I. Self-Regulatory Organization’s June 24, 2003. Pilot Program and the strike price The Auto-Ex Incentive Program Statement of the Terms of Substance of intervals for options on individual allows the Exchange to assign Auto-Ex the Proposed Rule Change stocks and ETFs. For these reasons, the orders to logged-on Market Makers Commission believes that there is good PCX proposes to amend its rules to according to the percentage of their in- cause, consistent with sections 6(b)(5) extend the Automatic Execution System person agency 8 contracts traded in an and 19(b) of the Act,19 to approve the (‘‘Auto-Ex’’) Incentive Pilot Program issue (excluding Auto-Ex contracts) Amex’s proposal, as amended, on an until June 30, 2004. The text of the compared to all of the Market Maker in- accelerated basis, through June 5, 2004. proposed rule change is available at the person agency contracts traded Office of the Secretary, PCX and at the V. Conclusion (excluding Auto-Ex contracts) during Commission. the review period. The review period is It is therefore ordered, pursuant to II. Self-Regulatory Organization’s determined by the Options Floor section 19(b)(2) of the Act,20 that the Statement of the Purpose of, and Trading Committee (‘‘OFTC’’) and may proposed rule change (SR–Amex–2003– be for any period of time not in excess 36) and Amendments No. 1 and 2 Statutory Basis for, the Proposed Rule Change of two weeks.9 The percentage thereto are hereby approved, on an distribution determined for a review accelerated basis and as a pilot program, In its filing with the Commission, the period will be effective for the through June 5, 2004. self-regulatory organization included succeeding review period. For the Commission, by the Division of statements concerning the purpose of, The Exchange is requesting an Market Regulation, pursuant to delegated and basis for, the proposed rule change additional extension of the pilot authority.21 and discussed any comments it received program from June 24, 2003 through Margaret H. McFarland, on the proposed rule change. The text June 30, 2004. The added time permits Deputy Secretary. of these statements may be examined at the Exchange to phase-in the Exchange’s [FR Doc. 03–15353 Filed 6–17–03; 8:45 am] the places specified in Item III below. new trading platform for options, ‘‘PCX PCX has prepared summaries, set forth 10 BILLING CODE 8010–01–P Plus’’, on an issue-by-issue basis. As in sections A, B, and C below, of the each issue is phased into PCX Plus, the most significant aspects of such Exchange will simultaneously phase-out SECURITIES AND EXCHANGE statements. such issue from the Auto-Ex Incentive COMMISSION A. Self-Regulatory Organization’s Program. PCX Plus will eventually [Release No. 34–48019; File No. SR–PCX– Statement of the Purpose of, and the replace the Auto-Ex Incentive Program 2003–16] Statutory Basis for, the Proposed Rule in its entirety. Therefore, the Exchange Change believes that an extension of the Self-Regulatory Organizations; Notice program is warranted until June 30, of Filing and Order Accelerating 1. Purpose 2004, the date on which PCX Plus will Approval of Proposed Rule Change On September 25, 2001, the be completely operative. and Amendment No. 1 Thereto by the Commission approved, as a nine-month 2. Statutory Basis Pacific Exchange, Inc. Relating to an pilot program, the Exchange’s proposal Amendment to the Auto-Ex Incentive to amend Rule 6.87, which governs the The Exchange believes that the Program operation of Auto-Ex,4 to provide an proposed rule change, as amended, is consistent with section 6(b)11 of the Act, June 11, 2003. 3 See Letter from Tania J. Cho, Regulatory Policy, in general, and furthers the objectives of Pursuant to section 19(b)(1) of the PCX, to Nancy J. Sanow, Assistant Director, Securities Exchange Act of 1934 Division of Market Regulation, Commission, dated 5 See Exchange Act Release No. 44847 (September (‘‘Act’’),1 and Rule 19b-4 thereunder,2 June 5, 2003 (‘‘Amendment No. 1’’). In Amendment 25, 2001), 66 FR 50237 (October 2, 2001) (SR–PCX– No. 1, PCX amended its proposal to request an 01–05). notice is hereby given that on May 21, extension of its Auto-Ex Incentive Program pilot 6 See Exchange Act Release No. 46115 (June 25, 2003, the Pacific Exchange, Inc. (‘‘PCX’’ until June 30, 2004, rather than June 24, 2004, as 2002), 67 FR 44494 (July 2, 2002) (SR–PCX–2002– stated in the original proposal, so that the pilot’s or ‘‘Exchange’’) filed with the Securities 34). expiration coincides with the date on which the and Exchange Commission 7 Exchange’s ‘‘PCX Plus’’ system will be completely See Exchange Act Release No. 47088 (December (‘‘Commission’’ or ‘‘SEC’’) the proposed operative. See supra n. 10 and accompanying text. 24, 2002), 68 FR 140 (January 2, 2003) (SR–PCX– 2002–78). rule change as described in Items I and 4 Auto-Ex is the Exchange’s Automated Execution 8 system feature of POETS for market or marketable Agency contracts are those contracts that are represented by an agent and do not include 17 See Securities Exchange Act Release No. 47991 limit orders. The Pacific Options Exchange Trading System (‘‘POETS’’) is the Exchange’s automated contracts traded between Markets Makers in person (June 5, 2003) (order approving File No. SR–CBOE– in the trading crowd. 2001–60). trading system comprised of an options order 9 The OFTC has set a two-week review period for 18 routing system, an automatic execution system See Securities Exchange Act Release No. 47753 all options classes and the OFTC will not vary the (April 29, 2003), 68 FR 23784 (May 5, 2003). (‘‘Auto-Ex’’), an on-line limit order book system and an automatic market quote update system. Option term of the review period except for exigent 19 15 U.S.C. 78f(b)(5) and 78s(b). orders can be sent to POETS via the Exchange’s circumstances. 20 15 U.S.C. 78s(b)(2). Member Firm Interface (‘‘MFI’’). Market and 10 See Exchange Act Release No. 47838 (May 13, 21 17 CFR 200.30–3(a)(12). marketable limit orders sent through the MFI will 2003), 68 FR 27129 (May 19, 2003) (‘‘ PCX Plus 1 15 U.S.C. 78s(b)(1). be executed by Auto-Ex if they meet the order type Order’’). 2 17 CFR 240.19b-4. and size requirements of the Exchange. 11 15 U.S.C. 78f(b).

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section 6(b)(5),12 in particular, in that it section 6(b)(5) of the Act.13 The Cocke, Jefferson and Sevier Counties in is designed to facilitate transactions in Commission notes that this proposal is the State of Tennessee as disaster areas securities, to promote just and equitable the latest in a series of Auto-Ex due to damages caused by severe principles of trade, to enhance Incentive Pilot Program extensions storms, tornadoes and flooding competition and to protect investors and previously approved by the occurring on May 4, 2003 and the public interest. Commission.14 Further, the Commission continuing through May 30, 2003. notes that the Auto-Ex Incentive Pilot In addition, applications for economic B. Self-Regulatory Organization’s Program itself has remained injury loans from small businesses Statement on Burden on Competition substantively unchanged since it was located in the contiguous counties of The Exchange does not believe that originally approved by the Commission Greene and Hamblen in the State of the proposed rule change, as amended, as a nine-month pilot.15 The Tennessee; and Haywood and Madison will impose any burden on competition Commission believes that an extension counties in the State of North Carolina that is not necessary or appropriate in until June 30, 2004 provides an may be filed until the specified date at furtherance of the purposes of the Act. appropriate period of time for the the previously designated location. All C. Self-Regulatory Organization’s Exchange to continue its Auto-Ex other counties contiguous to the above Statement on Comments on the Incentive Program while it phases-in its named primary counties have been new trading platform for options, ‘‘PCX Proposed Rule Change Received From previously declared. Plus,’’ on an issue-by-issue basis. Once Members, Participants or Others All other information remains the ‘‘PCX Plus’’ is fully implemented, the same, i.e., the deadline for filing Written comments on the proposed Exchange no longer will need to operate applications for physical damage is July rule change were neither solicited nor its Auto-Ex system.16 Accordingly, the 7, 2003, and for economic injury the received. Commission finds good cause for deadline is February 6, 2004. approving the proposed rule change, as III. Solicitation of Comments (Catalog of Federal Domestic Assistance amended, prior to the thirtieth day after Program Nos. 59002 and 59008). Interested persons are invited to the date of publication of notice thereof Dated: June 12, 2003. submit written data, views and in the Federal Register. arguments concerning the foregoing, Herbert L. Mitchell, including whether the proposed rule V. Conclusion Associate Administrator for Disaster change, as amended, is consistent with Is it therefore ordered, pursuant to Assistance. the Act. Persons making written section 19(b)(2) of the Act,17 that the [FR Doc. 03–15357 Filed 6–17–03; 8:45 am] submissions should file six copies proposed rule change (SR–PCX–2003– BILLING CODE 8025–01–P thereof with the Secretary, Securities 16), as amended, is hereby approved on and Exchange Commission, 450 Fifth an accelerated basis, as a pilot program Street, NW, Washington, DC 20549– scheduled to expire on June 30, 2004. SMALL BUSINESS ADMINISTRATION 0609. Copies of the submission, all For the Commission by the Division of [Declaration of Disaster #3510] subsequent amendments, all written Market Regulation, pursuant to delegated statements with respect to the proposed authority.18 Commonwealth of Virginia rule change that are filed with the Margaret H. McFarland, Southampton County and the Commission, and all written Deputy Secretary. communications relating to the contiguous counties of Greensville, Isle [FR Doc. 03–15313 Filed 6–17–03; 8:45 am] proposed rule change between the of Wight, Surry, Sussex, and the Commission and any person, other than BILLING CODE 8010–01–P Independent Cities of Franklin and those that may be withheld from the Suffolk in the Commonwealth of public in accordance with the Virginia; and Gates, Hertford, and SMALL BUSINESS ADMINISTRATION provisions of 5 U.S.C. 552, will be Northampton Counties in the State of available for inspection and copying in [Declaration of Disaster #3498] North Carolina constitute a disaster area the Commission’s Public Reference due to damages caused by severe Room. Copies of such filing will also be State of Tennessee; (Amendment #5) storms, hail, and tornadoes that available for inspection and copying at occurred on May 9, 2003. Applications In accordance with a notice received for loans for physical damage may be the principal office of PCX. All from the Department of Homeland submissions should refer to the File No. filed until the close of business on Security—Federal Emergency August 11, 2003 and for economic SR–PCX–2003–16 and should be Management Agency, effective June 10, submitted by July 9, 2003. injury until the close of business on 2003, the above numbered declaration is March 11, 2004 at the address listed IV. Commission’s Findings and Order hereby amended to include Blount, below or other locally announced Granting Accelerated Approval of locations: U.S. Small Business Proposed Rule Change 13 Id. In approving this rule, the Commission notes that it has considered the proposed rule’s Administration, Disaster Area 1 Office, The Exchange has requested that the impact on efficiency, competition, and capital 360 Rainbow Blvd., South 3rd Floor, Commission approve this proposed rule formation. See 15 U.S.C. 78c(f). Niagara Falls, NY 14303. change on an accelerated basis. After 14 See Exchange Act Release No. 47088 The interest rates are: careful consideration, the Commission (December 24, 2002), 68 FR 140 (January 2, 2003) (SR–PCX–2002–78) (six-month extension); Percent finds that the proposed rule change, as Securities Exchange Act Release No. 46115 (June amended, is consistent with the 25, 2002); 67 FR 44494 (July 2, 2002) (SR–PCX– For Physical Damage: requirements of the Act and the rules 2002–34) (six-month extension). 15 Homeowners with credit avail- and regulations thereunder applicable to See Exchange Act Release No. 44847 (September 25, 2001), 66 FR 50237 (October 2, able elsewhere ...... 5.625 a national securities exchange, and, in 2001) (SR–PCX–01–05). Homeowners without credit particular, with the requirements of 16 See PCX Plus Order, supra n. 10. available elsewhere ...... 2.812 17 15 U.S.C. 78s(b)(2). Businesses with credit available 12 15 U.S.C. 78f(b)(5). 18 17 CFR200.30–3(a)(12). elsewhere ...... 5.906

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Percent (202) 647–7407 or e-mail to CONTACT. The FAA will consider all [email protected] not later than 24 communications received by the closing Businesses and non-profit orga- hours before the meeting: (1) Name of date before issuing the final AC. nizations without credit avail- the meeting, (2) your name, and (3) Background able elsewhere ...... 2.953 organizational affiliation. A valid photo Others (including non-profit or- ID must be presented to gain entrance to This AC provides guidance and ganizations) with credit avail- the National Academy of Sciences acceptable methods, but not the only able elsewhere ...... 5.500 methods, for demonstrating compliance For Economic Injury: Building. Directions to the meeting Businesses and small agricul- location may be obtained by calling the with the rotor strength (overspeed) tural cooperatives without ITAC Secretariat at 202 647–2592 or e- requirements of § 33.27 of title 14 of the credit available elsewhere ..... 2.953 mail to [email protected]. Code of Federal Regulations (14 CFR 33.27). Dated: June 5, 2003. The numbers assigned to this disaster Joseph P. Richardson, (Authority: 49 U.S.C. 106(g), 40113, 44701– for physical damage are 351012 for 44702, 44704.) Virginia and 351112 for North Carolina. Office of Multilateral Affairs, International Issued in Burlington, Massachusetts, on The numbers assigned to this disaster Communications and Information Policy, Department of State. June 11, 2003. for economic damage are 9V8100 for Peter A. White, Virginia and 9V8200 for North Carolina. [FR Doc. 03–15386 Filed 6–17–03; 8:45 am] BILLING CODE 4710–45–P Acting Manager, Engine and Propeller (Catalog of Federal Domestic Assistance Directorate, Aircraft Certification Service. Program Nos. 59002 and 59008.) [FR Doc. 03–15402 Filed 6–17–03; 8:45 am] Dated: June 11, 2003. DEPARTMENT OF TRANSPORTATION BILLING CODE 4910–13–M Hector V. Barreto, Administrator. Federal Aviation Administration [FR Doc. 03–15358 Filed 6–17–03; 8:45 am] DEPARTMENT OF TRANSPORTATION BILLING CODE 8025–01–P Proposed Advisory Circular; Turbine Rotor Strength Requirements Federal Railroad Administration AGENCY: Federal Aviation Petitions for Waivers of Compliance DEPARTMENT OF STATE Administration, DOT. In accordance with title 49 Code of ACTION: Notice of availability of [Public Notice 4351] Federal Regulations (CFR) section proposed advisory circular and request 211.41, and 49 U.S.C. 20103, this notice United States International for comments. Telecommunication Advisory is hereby given that the Federal Railroad Committee Information Meeting on the SUMMARY: The Federal Aviation Administration (FRA) has received a World Summit on the Information Administration (FAA) announces the request for a waiver of compliance from Society and the U.S. Preparatory availability of proposed advisory certain requirements of its safety Process circular (AC) Number 33.27–1, Turbine regulations. The individual petition is Rotor Strength Requirements of 14 CFR described below, including the party The Department of State announces 33.27. seeking relief, the regulatory provisions meetings of the U.S. International DATES: Comments must be received on involved, the nature of the relief being Telecommunication Advisory or before August 1, 2003. sought, and the petitioner’s argument in Committee (ITAC). The purpose of the favor of relief. ADDRESSES: Send all comments on the Committee is to advise the Department proposed AC to the Federal Aviation on matters related to telecommunication Canadian National Railway; FRA Administration, Attn: Tim Mouzakis, and information policy matters in Waiver Petition No. FRA–2003–15012 Engine and Propeller Standards Staff, preparation for international meetings Canadian National Railway (CN) ANE–110, 12 New England Executive pertaining to telecommunication and located in Montreal, Canada, seeks a Park, Burlington, MA 01803–5299. information issues. permanent waiver of compliance from The ITAC will meet to discuss the FOR FURTHER INFORMATION CONTACT: Tim 49 CFR 241.7(c), United States matters related to the World Summit on Mouzakis, Engine and Propeller Locational Requirements for the Information Society (WSIS), which Standards Staff, ANE–110, at the above Dispatching of United States Rail will take place in December 2003, address; telephone: (781) 238–7114; fax: Operations, to allow the continuation of including U.S. preparations for the (781) 238–7199; e-mail: Canadian dispatching of that part of the WSIS. The meeting will take place on [email protected]. Sprague Subdivision located in the Wednesday, July 9, 2003 from 10:30 SUPPLEMENTARY INFORMATION: United States, extending between a.m. to 12 p.m. at the Historic National Baudette, Minnesota, and International Academy of Science Building. The Comments Invited Boundary, Minnesota, approximately National Academy of Sciences is located A copy of the subject AC may be 43.8 miles and on those parts of the at 2100 C St. NW., Washington, DC. obtained by contacting the person Strathroy and Flint Subdivisions located This meeting announcement does not named under FOR FURTHER INFORMATION in the United States, forming a meet the official deadline due to CONTACT or by donwloading the continuous line between Sarnia, constraints imposed by the travel of proposed AC from the following Ontario, Canada, through the St. Clair senior officials who will brief on WSIS. Internet Web site: http:// River Tunnel, and Port Huron, Members of the public are welcome to www.airweb.faa.gov/rgl. The FAA Michigan, approximately 3.1 miles, as participate and may join in the invites interested parties to comment on defined in appendix A to part 241. This discussions, subject to the discretion of the proposed AC. Comments should request formalizes the request for waiver the Chair. People intending to attend a identify the subject of the AC and be requirement contained in part 241, meeting at the Department of State submitted to the individual identified specifically § 241.7(c)(3), which refers to should send the following data by fax to under FOR FURTHER INFORMATION territory that was previously

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grandfathered in the exceptions to Based on the foregoing, CN seeks a DEPARTMENT OF TRANSPORTATION extraterritorial dispatching contained in permanent waiver of compliance from FRA’s Interim Final Rule (see 66 FR 49 CFR 241.7(c), United States Federal Railroad Administration 63942, December 11, 2001). Locational Requirements for Petitions for Waivers of Compliance In this regard, the track segments Dispatching of United States Rail identified in the Interim Final Rule Operations, to allow the continuation of In accordance with Title 49 Code of remains the same as identified above. Canadian dispatching on that part of the Federal Regulations (CFR) section With respect to the Sprague Sprague Subdivision located in the 211.41, and 49 U.S.C. 20103, this notice Subdivision, this is part of a continuous United States and on those parts of the is hereby given that the Federal Railroad line extending between Rainy River, Strathroy and Flint Subdivisions located Administration (FRA) has received a Ontario, and Navin, Manitoba, Canada, in the United States, as described above. request for a waiver of compliance from a distance of 145.2 miles, a portion of Interested parties are invited to certain requirements of its safety which cuts across a corner of the State participate in this proceeding by regulations. The individual petition is of Minnesota, from the U.S./Canadian submitting written views, data, or described below, including the party border near Baudette, Minnesota comments. FRA does not anticipate seeking relief, the regulatory provisions (milepost 1.1), and the U.S./Canadian scheduling a public hearing in involved, the nature of the relief being border at a point identified as connection with the request for a waiver sought, and the petitioner’s argument in International Boundary, Minnesota, of certain regulatory provisions. If any favor of relief. milepost 44.9, a distance of interested party desires an opportunity approximately 43.8 miles. Canadian Pacific Railway; FRA Waiver for oral comment, he or she should Petition No. FRA–2003–15010 Approximately 15 trains per day are notify FRA, in writing, before the end of operated over this segment. Each train the comment period and specify the Canadian Pacific Railway (CP) located that traverses this territory is operated basis for his or her request. All in Montreal, Canada, seeks a permanent by the same crew. The entire Sprague communications concerning these waiver of compliance from 49 CFR Subdivision is single track and is proceedings should identify the 241.7(c), United States Locational operated under a Centralized Traffic appropriate docket number (Docket Requirements for Dispatching of United Control system, controlled from a single States Rail Operations to allow the Number FRA 2003–15012) and must be dispatching desk at CN’s Rail Traffic continuation of Canadian dispatching of submitted to the DOT Docket Control Center in Edmonton, Alberta, that part of the Windsor Subdivision Management Facility, Room PL–401 Canada. With respect to the Strathroy located in the United States, extending (Plaza level) 400 Seventh Street, SW., and Flint Subdivisions, this is part of a between Windsor, Ontario, Canada, and Washington, DC 20590. All documents continuous line extending between Detroit, Michigan, approximately 1.8 in the public docket, including CN’s London, Ontario, Canada, and Port miles, as defined in appendix A to part detailed waiver request, are also Huron, Michigan, a distance of 61.7 241. This request formalizes the request available for inspection and copying on miles, a 3.1 mile portion of which is for waiver requirement contained in the Internet at the docket facility’s Web located in the United States. part 241, specifically § 241.7(c)(3), site at http://dms.dot.gov. Approximately 26 trains per day are which refers to territory that was operated over this segment. Each train Communications received within 30 previously grandfathered in the that traverses this territory is operated days of the date of this notice will be exceptions to extraterritorial by the same crew. This segment consists considered by FRA before final action is dispatching contained in FRA’s Interim of a single track for approximately 1.1 taken. Comments received after that Final Rule (see 66 FR 63942, December miles, and two main tracks for the date will be considered as far as 11, 2001). remaining 2.0 miles, and is operated practicable. All written communications In this regard, the track segment under a Centralized Traffic Control concerning this proceeding are available identified in the Interim Final Rule system, controlled from a single for examination during regular business remains the same as identified above. dispatching desk at CN’s Rail Traffic hours (9 a.m.–5 p.m.) at the above All trains operated into the United Control Center in Toronto, Ontario, facility. States are of very short distances to an Canada. Dispatching of all trackage of FRA wishes to inform all potential interchange point with a U.S. railroad the Sprague Subdivision and the commenters that anyone is able to and are always under the control of a Strathroy and Flint Subdivisions is an search the electronic form of all single crew. All dispatching is entirely English operation and fully comments received into any of our conducted in English. All units of dispatched in English. Canadian Rail dockets by the name of the individual measure are the same as those used in Operating Rules (CROR) and CN’s submitting the comment (or signing the the U.S. Because of the very short Timetable and Special Instructions comment, if submitted on behalf of an distances, all train operations in the govern train operations on this trackage. association, business, labor union, etc.). U.S. are under the control of a single CN uses English (or Imperial) units for You may review DOT’s complete dispatching desk, located in CP’s all aspects of railroad operations, Privacy Act Statement in the Federal Network Management Center in including distance, speed, and location. Register published on April 11, 2000 Montreal, Quebec, Canada. CP operates The CN dispatchers are covered under (Volume 65, Number 70; Pages 19477– approximately 6 to 8 trains a day over their company drug and alcohol policies 78) or you may visit http://dms.dot.gov. this segment. The trackage is operated and their dispatching office is under 24- under a Centralized Traffic Control Issued in Washington, DC on June 11, hour security. Transport Canada Rail system and consists of two main tracks 2003. Safety Directorate has the legislative for the entire 1.8 mile distance. safety jurisdiction over CN in Grady C. Cothen, Jr., Movements are governed by the accordance with the provisions Deputy Associate Administrator for Safety Canadian Rail Operating Rules (CROR) contained in the Railway Safety Act Standards and Program Development. and CP’s Timetable and Special over all federally regulated railways [FR Doc. 03–15394 Filed 6–17–03; 8:45 am] Instructions. CP’s train dispatchers are operating in Canada. BILLING CODE 4910–06–P covered under their company drug and

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alcohol policies and their dispatching Issued in Washington, DC, on June 11, the facts do not appear to warrant a office is under 24-hour security. 2003. hearing. If any interested party desires Transport Canada Rail Safety Grady C. Cothen, Jr., an opportunity for oral comment, they Directorate has the legislative safety Deputy Associate Administrator for Safety should notify FRA in writing before the jurisdiction over CP in accordance with Standards and Program Development. end of the comment period and specify the provisions contained in the Railway [FR Doc. 03–15391 Filed 6–17–03; 8:45 am] the basis for their request. Safety Act over all federally regulated BILLING CODE 4910–06–P All communication concerning these railways operating in Canada. proceedings should identify the Based on the foregoing, CP seeks a appropriate docket number (e.g., Waiver DEPARTMENT OF TRANSPORTATION permanent waiver of compliance from Petition Docket Number 2003–14986) 49 CFR 241.7(c), United States Federal Railroad Administration and must be submitted to the Docket Locational Requirements for Clerk, DOT Docket Management Dispatching of United States Rail Petition for Waiver of Compliance Facility, Room PL–401 (Plaza Level), Operations, to allow the continuation of 400 7th Street, SW., Washington, DC Canadian dispatching on that part of the In accordance with part 211 of Title 20590. Communications received within Windsor Subdivision located in the 49 Code of Federal Regulations (CFR), 45 days of the date of this notice will United States, between Windsor, notice is hereby given that the Federal be considered by FRA before final Ontario, Canada, and Detroit, Michigan, Railroad Administration (FRA) received action is taken. Comments received after approximately 1.8 miles. a request for a waiver of compliance that date will be considered as far as with certain requirements of its safety practicable. All written communications Interested parties are invited to standards. The individual petition is concerning these proceedings are participate in this proceeding by described below, including the party available for examination during regular submitting written views, data, or seeking relief, the regulatory provisions business hours (9 a.m.–5 p.m.) at the comments. FRA does not anticipate involved, the nature of the relief being above facility. All documents in the scheduling a public hearing in requested, and the petitioner’s public docket are also available for connection with the request for a waiver arguments in favor of relief. inspection and copying on the Internet of certain regulatory provisions. If any Dakota, Minnesota & Eastern Railroad at the docket facility’s Web site at interested party desires an opportunity http://dms.dot.gov. for oral comment, he or she should [Docket Number FRA–2003–14986] notify FRA, in writing, before the end of Dakota, Minnesota & Eastern Railroad FRA wishes to inform all potential the comment period and specify the (DM&E) seeks a waiver of compliance commenters that anyone is able to basis for his or her request. All from the provisions of the Track Safety search the electronic form of all communications concerning these Standards, 49 CFR 213.113(a), regarding comments received into any of our proceedings should identify the defective rails. dockets by the name of the individual appropriate docket number (Docket The DM&E is petitioning for a waiver submitting the comment (or signing the Number FRA 2003–15010) and must be which would provide relief from comment, if submitted on behalf of an submitted to the DOT Docket replacing rails that contain bolt hole/rail association, business, labor union, etc.). Management Facility, Room PL–401 crack-outs that emanate from the edge of You may review DOT’s complete (Plaza level) 400 Seventh Street, SW., the rail to the bolt hole ‘one’ location of Privacy Act Statement in the Federal Washington, DC 20590. All documents various rail joint locations. Register published on April 11, 2000 in the public docket, including CP’s The petitioner states that rails with (volume 65, number 70; pages 19477– detailed waiver request, are also bolt-hole/rail crack-outs up to 6″ 78), or you may visit http://dms.dot.gov. available for inspection and copying on maximum from the end of the rail to the the Internet at the docket facility’s Web Issued in Washington, DC on June 11, bolt hole ‘one’ location can be allowed 2003. site at http://dms.dot.gov. to remain in service as the broken-out Grady C. Cothen, Jr., Communications received within 30 piece of rail remains tightly held by the days of the date of this notice will be joint bars and thus poses less danger of Deputy Associate Administrator for Safety Standards and Program Development. considered by FRA before final action is breaking loose. The petitioner proposes taken. Comments received after that to institute a 10 MPH slow order at [FR Doc. 03–15399 Filed 6–17–03; 8:45 am] date will be considered as far as these locations as well as schedule daily BILLING CODE 4910–06–P practicable. All written communications visual inspections in lieu of constant concerning this proceeding are available visual inspection of each operation over DEPARTMENT OF TRANSPORTATION for examination during regular business that defect (for up to no more than 30 hours (9 a.m.–5 p.m.) at the above days for any instance) by qualified Federal Railroad Administration facility. personnel as per 49 CFR 213.7. If the FRA wishes to inform all potential cracks grow greater than 6″ from the Petitions for Waivers of Compliance commenters that anyone is able to edge of rail or the rail section becomes search the electronic form of all loose, priority will be given to that In accordance with title 49 Code of comments received into any of our location for an immediate rail Federal Regulations (CFR) section dockets by the name of the individual replacement. The petitioner feels that 211.41 and 49 U.S.C. 20103, this notice submitting the comment (or signing the this will enable the DM&E to more is hereby given that the Federal Railroad comment, if submitted on behalf of an efficiently utilize its limited resources. Administration (FRA) has received a association, business, labor union, etc.). Interested parties are invited to request for a waiver of compliance from You may review DOT’s complete participate in these proceedings by certain requirements of its safety Privacy Act Statement in the Federal submitting written views, data, or regulations. The individual petition is Register published on April 11, 2000 comments. FRA does not anticipate described below, including the party (Volume 65, Number 70; Pages 19477– scheduling a public hearing in seeking relief, the regulatory provisions 78) or you may visit http://dms.dot.gov. connection with these proceedings since involved, the nature of the relief being

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sought, and the petitioner’s argument in Interested parties are invited to standards. The individual petition is favor of relief. participate in this proceeding by described below, including the party submitting written views, data, or seeking relief, the regulatory provisions Eastern Maine Railway; FRA Waiver comments. FRA does not anticipate involved, the nature of the relief being Petition No. FRA–2003–15011 scheduling a public hearing in requested, and the petitioner’s Eastern Maine Railway (EMRY), connection with the request for a waiver arguments in favour of relief. of certain regulatory provisions. If any located in St. John, New Brunswick, National Railroad Passenger interested party desires an opportunity Canada, seeks a permanent waiver of Corporation compliance from 49 CFR 241.7(c), for oral comment, he or she should United States Locational Requirements notify FRA, in writing, before the end of [Docket Number FRA–2003–14444] for Dispatching of United States Rail the comment period and specify the The National Railroad Passenger Operations, to allow the continuation of basis for his or her request. All Corporation (Amtrak) has petitioned for Canadian dispatching of that part of communications concerning these a permanent waiver of compliance for Mattawamkeag Subdivision located in proceedings should identify the the Acela trainsets and HHP–8 Electric the United States extending between appropriate docket number (Docket locomotives from certain dimensional Vanceboro, Maine, and Brownville Number FRA 2003–15011) and must be requirements of the Railroad Passenger Junction, Maine, approximately 99 submitted to the DOT Docket Equipment Safety Standards, 49 CFR miles, as defined in Appendix A to Part Management Facility, Room PL–401 238.429 and Safety Appliance 241. This request was submitted in (Plaza level) 400 Seventh Street, SW., Standards, 49 CFR 231.14. Amtrak accordance with § 241.7(c)(3), which Washington, DC 20590. All documents requests this relief due to the unique permits waiver of the requirements in the public docket, including EMRY’s carbody design of this new equipment found in Part 241 that all dispatching of detailed waiver request, are also and its structural frame that precludes U.S. rail operations be conducted in the available for inspection and copying on installation of safety appliances U.S. This territory was previously the Internet at the docket facility’s Web compliant with the safety standards. grandfathered in the exceptions to site at http://dms.dot.gov. Amtrak and the equipment’s extraterritorial dispatching contained in Communications received within 30 manufacturer have made every effort to FRA’s Interim Final Rule (see 66 FR days of the date of this notice will be bring the safety appliance arrangement 63942, December 11, 2001). considered by FRA before final action is into compliance, but find it not possible taken. Comments received after that for the following items: In this regard, the track segment • identified in the Interim Final Rule date will be considered as far as Requirements of § 238.429(d)(4) & remains the same as identified above. practicable. All written communications § 231.14(c)(3)(ii)—‘‘The maximum and minimum distances from the top of the This segment consists of a single main concerning this proceeding are available rail for vertical handrails and handholds track dispatched from a single desk at for examination during regular business hours (9 a.m.–5 p.m.) at the above shall be 51 inches***’’. the EMRY’s Rail Traffic Control office in Proposed alternate compliance—The St. John, New Brunswick, Canada, facility. FRA wishes to inform all potential current handholds are approximately 68 under Canadian Rail Operating Rules commenters that anyone is able to inches from the top of the rail. The (CROR), and the EMRY’s Timetable and search the electronic form of all structural integrity of the carbody side Special Instructions. The trackage is comments received into any of our sill would be compromised by strict non-signaled and operated under dockets by the name of the individual adherence to this dimensional Occupancy Control System rules. All submitting the comment (or signing the requirement. Amtrak proposes an dispatching is conducted in English. All comment, if submitted on behalf of an alternate solution with the installation units of measure are the same as those association, business, labor union, etc.). of additional horizontal handholds on used in the U.S. EMRY operates You may review DOT’s complete either side of the cab door, approximately 2 trains a day over this Privacy Act Statement in the Federal approximately 53 to 54 inches from the segment. The train dispatchers who Register published on April 11, 2000 top of the rail. These additional perform the dispatching function for the (Volume 65, Number 70; Pages 19477– handholds will provide personnel the EMRY are employed by the New 78) or you may visit http://dms.dot.gov. support necessary for a safe ingress to Brunswick Southern Railway (NBSR) the powercar or locomotive cab area and are therefore covered under the Issued in Washington, DC on June 11, while eliminating the danger of NBSR’s company drug and alcohol 2003. weakening the side sill structure. policies and their dispatching office is Grady C. Cothen, Jr., Additionally, carbody clearance under 24-hour security. The Department Deputy Associate Administrator for Safety constraints and strict infrastructure of Transportation of the Province of Standards and Program Development. clearance limits dictate that the New Brunswick, Canada, is the [FR Doc. 03–15395 Filed 6–17–03; 8:45 am] horizontal handholds have a maximum regulatory authority which exercises BILLING CODE 4910–06–P clearance of 2.0 inches. safety jurisdiction over the New • Requirements of § 238.429(d)(5)— Brunswick Southern Railway, which ‘‘Vertical handrails and handholds shall provides dispatching services for the DEPARTMENT OF TRANSPORTATION continue to a point equal to the top edge EMRY. of the control cab door.’’ Based on the foregoing, EMRY seeks Federal Railroad Administration Relief Requested—The powercar’s a permanent waiver of compliance from Petition for Waiver of Compliance structural members are arranged such 49 CFR 241.7(c), United States that they extend to a point several Locational Requirements for In accordance with part 211 of title 49 inches below the top of the control cab Dispatching of United States Rail Code of Federal Regulations (CFR), door to maximize the integrity of the Operations, to allow the continuation of notice is hereby given that the Federal upper framework. The vertical Canadian dispatching on that part of the Railroad Administration (FRA) received handholds are arranged to avoid Mattawamkeag Subdivision located in a request for a waiver of compliance interference with these structural the United States, as described above. with certain requirements of its safety members. Serious consideration was

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given toward applying a horizontal Washington, DC, 20590–0001. Subdivision. The proposed changes handhold on the uppermost portion of Communications received within 45 consist of the conversion of the power- the doorframe interior as an alternate days of the date of this notice will be operated switch to hand operation, compliance, but after further analysis considered by FRA before final action is equipped with an electric lock, and Amtrak determined that this would pose taken. Comments received after that removal of the three associated absolute a greater safety risk during the ingress date will be considered as far as controlled signals on Main Track No. 2, and egress of personnel at this location. practicable. All written communications and the discontinuance and removal of Therefore, permanent relief from the concerning these proceedings are the back to back intermediate signals on requirement that the vertical handhold available for examination during regular Main Track No. 1. continue to a point equal to the top edge business hours (9 a.m.—5 p.m.) at the The reasons given for the proposed of the control cab door is requested. above facility. All documents in the • changes are that the switch at one time Requirements of § 238.429(e)(4) & public docket are also available for was used for passenger service to the 231.14(b)(2)—‘‘The minimum clear inspection and copying on the Internet depot, but now the track is used to tie depth of the sill step shall be 8 inches’’. at the docket facility’s Web site at up a switch engine once or twice a Regarding the sill steps, to decrease http://dms.dot.gov. week, and due to the short blocks on the distance in the vertical rise FRA wishes to inform all potential Main Track No. 1. measurement from the original 21 commenters that anyone is able to inches it was necessary to raise the search the electronic form of all Any interested party desiring to upper step. This revised design comments received into any of our protest the granting of an application maintains the clear depth measurement dockets by the name of the individual shall set forth specifically the grounds at 7.5 inches. Amtrak believes that submitting the comment (or signing the upon which the protest is made, and decreasing the vertical rise while comment, if submitted on behalf of an include a concise statement of the maintaining the depth between the step association, business, labor union, etc.). interest of the party in the proceeding. and the carbody ensures a safer sill step You may review DOT’s complete Additionally, one copy of the protest area. Privacy Act Statement in the Federal shall be furnished to the applicant at the • Requirements of § 238.429(e)(6) & Register published on April 11, 2000 address listed above. § 231.14(b)(4)—‘‘Sill steps shall not (Volume 65, Number 70; Pages 19477– All communications concerning this have a vertical rise between treads 78) or you may visit http://dms.dot.gov. proceeding should be identified by the exceeding 18 inches’’. docket number and must be submitted Proposed alternate compliance—The Issued in Washington, DC on June 11, to the Docket Clerk, DOT Central Docket 2003. original sill step configuration had a Management Facility, Room PL–401 vertical rise of 21 inches due to Grady C. Cothen, Jr., (Plaza Level), 400 7th Street, SW., constraints with the design of the Deputy Associate Administrator for Safety Washington, DC 20590–0001. carbody’s side sill. This alternate design Standards and Program Development. Communications received within 45 lowers this distance to approximately 20 [FR Doc. 03–15392 Filed 6–17–03; 8:45 am] days of the date of this notice will be inches. However, further decrease of BILLING CODE 4910–06–P considered by the FRA before final this dimension would result in a action is taken. Comments received after corresponding decrease of the 7.5-inch that date will be considered as far as DEPARTMENT OF TRANSPORTATION clear depth of the sill step. practicable. All written communications • Requirements of § 238.429(e)(10)— Federal Railroad Administration concerning these proceedings are ‘‘50% of the tread surface area of each available for examination during regular sill step shall be open space’’. Notice of Application for Approval of business hours (9 a.m.–5 p.m.) at the Proposed alternate compliance— Discontinuance or Modification of a above facility. All documents in the Amtrak believes that the current Railroad Signal System or Relief From public docket are also available for serrated design for the lower step, with the Requirements of Title 49 Code of inspection and copying on the internet 2.25-inch high foot guards on each side, Federal Regulations Part 236 at the docket facility’s Web site at combined with a non-skid surface http://dms.dot.gov. material would provide a safer tread Pursuant to Title 49 Code of Federal surface than a more traditional open Regulations (CFR) part 235 and 49 FRA wishes to inform all potential space design. U.S.C. 20502(a), the following railroad commenters that anyone is able to Interested parties are invited to has petitioned the Federal Railroad search the electronic form of all participate in these proceedings by Administration (FRA) seeking approval comments received into any of our submitting written views, data, or for the discontinuance or modification dockets by the name of the individual comments. FRA does not anticipate of the signal system or relief from the submitting the comment (or signing the scheduling a public hearing in requirements of 49 CFR part 236 as comment, if submitted on behalf of an connection with these proceedings since detailed below. association, business, labor union, etc.). You may review DOT’s complete the facts do not appear to warrant a Docket No. FRA–2003–15301 hearing. If any interested party desires Privacy Act Statement in the Federal an opportunity for oral comment, they Applicant: Burlington Northern and Register published on April 11, 2000 should notify FRA, in writing, before Santa Fe Railway, Mr. William G. (Volume 65, Number 70; Pages 19477– the end of the comment period and Peterson, Director Signal Engineering, 78) or you may visit http://dms.dot.gov. specify the basis for their request. 4515 Kansas Avenue, Kansas City, FRA expects to be able to determine All communications concerning these Kansas 66106. these matters without an oral hearing. proceedings should identify the Burlington Northern and Santa Fe However, if a specific request for an oral appropriate docket number (Waiver Railway (BNSF) seeks approval of the hearing is accompanied by a showing Petition Docket Number FRA–2003– proposed modification of the traffic that the party is unable to adequately 14444) and must be submitted to the control system, on the two main tracks present his or her position by written Docket Clerk, DOT Central Docket at Burlington, Iowa, milepost 205.48, on statements, an application may be set Management Facility, Room PL–401, the Nebraska Division, Ottumwa for public hearing.

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Issued in Washington, DC on June 11, to the Docket Clerk, DOT Central Docket Docket No. FRA–2003–15194 2003. Management Facility, Room PL–401 Applicant: CSX Transportation, Grady C. Cothen, Jr., (Plaza Level), 400 7th Street, SW., Incorporated, Mr. Eric G. Peterson, Deputy Associate Administrator for Safety Washington, DC 20590–0001. Assistant Chief Engineer, Signal Standards and Program Development. Communications received within 45 Design and Construction, 4901 Belfort [FR Doc. 03–15393 Filed 6–17–03; 8:45 am] days of the date of this notice will be Road, Suite 130 (S/C J–370), BILLING CODE 4910–06–P considered by the FRA before final Jacksonville, Florida 32256. action is taken. Comments received after CSX Transportation, Incorporated that date will be considered as far as DEPARTMENT OF TRANSPORTATION seeks approval of the proposed practicable. All written communications modification of the traffic control concerning these proceedings are Federal Railroad Administration system at South Wye, milepost ANA available for examination during regular 587.80, near Waycross, Georgia, on the Notice of Application for Approval of business hours (9 a.m.–5 p.m.) at the Jesup Subdivision, Jacksonville Service Discontinuance or Modification of a above facility. All documents in the Lane. The proposed change consists of Railroad Signal System or Relief From public docket are also available for the discontinuance and removal of the Requirements of Title 49 Code of inspection and copying on the internet controlled absolute signal 220RD, Federal Regulations Part 236 at the docket facility’s Web site at associated with the addition of aspects http://dms.dot.gov. to controlled absolute signal 222RA to Pursuant to title 49 Code of Federal FRA wishes to inform all potential govern southward diverging routes from Regulations (CFR) part 235 and 49 commenters that anyone is able to Rice Yard to the Main Track. U.S.C. 20502(a), the following railroad search the electronic form of all The reason given for the proposed has petitioned the Federal Railroad comments received into any of our changes is to eliminate facilities no Administration (FRA) seeking approval dockets by the name of the individual longer needed in present day operation. for the discontinuance or modification submitting the comment (or signing the Any interested party desiring to of the signal system or relief from the comment, if submitted on behalf of an protest the granting of an application requirements of 49 CFR part 236 as association, business, labor union, etc.). shall set forth specifically the grounds detailed below. You may review DOT’s complete upon which the protest is made, and Docket No. FRA–2003–15145 Privacy Act Statement in the Federal include a concise statement of the Register published on April 11, 2000 interest of the party in the proceeding. Applicant: Burlington Northern and (Volume 65, Number 70; Pages 19477– Additionally, one copy of the protest Santa Fe Railway, Mr. William G. 78) or you may visit http://dms.dot.gov. shall be furnished to the applicant at the Peterson, Director Signal Engineering, FRA expects to be able to determine address listed above. 4515 Kansas Avenue, Kansas City, All communications concerning this Kansas 66106. these matters without an oral hearing. However, if a specific request for an oral proceeding should be identified by the Burlington Northern and Santa Fe hearing is accompanied by a showing docket number and must be submitted Railway (BNSF) seeks approval of the that the party is unable to adequately to the Docket Clerk, DOT Central Docket proposed discontinuance and removal present his or her position by written Management Facility, Room PL–401 of the automatic block signal system, statements, an application may be set (Plaza Level), 400 7th Street, SW., between Hettinger, North Dakota, for public hearing. Washington, DC 20590–0001. milepost 926.0 and Terry, Montana, Communications received within 45 milepost 1078.9, on the Montana Issued in Washington, DC, on June 11, days of the date of this notice will be Division, Hettinger Subdivision, a 2003. considered by the FRA before final distance of approximately 153 miles, Grady C. Cothen, Jr., action is taken. Comments received after with governance of train movements by Deputy Associate Administrator for Safety that date will be considered as far as Track Warrant Control. Standards and Program Development. practicable. All written communications The reason given for the proposed [FR Doc. 03–15397 Filed 6–17–03; 8:45 am] concerning these proceedings are changes is that due to an ice storm BILLING CODE 4910–06–P available for examination during regular which disabled about 35 percent of the business hours (9 a.m.–5 p.m.) at the pole line on the Subdivision, the signal above facility. All documents in the pole line is in need of large amounts of DEPARTMENT OF TRANSPORTATION public docket are also available for replacement capital to restore and inspection and copying on the internet rehabilitate this line. BNSF believes that Federal Railroad Administration at the docket facility’s Web site at this scarce capital would be much better http://dms.dot.gov. spent on other lines with greater track Notice of Application for Approval of FRA wishes to inform all potential density, because this line averages only Discontinuance or Modification of a commenters that anyone is able to four trains per day. Railroad Signal System or Relief From search the electronic form of all Any interested party desiring to the Requirements of Title 49 Code of comments received into any of our protest the granting of an application Federal Regulations Part 236 dockets by the name of the individual shall set forth specifically the grounds submitting the comment (or signing the upon which the protest is made, and Pursuant to Title 49 Code of Federal comment, if submitted on behalf of an include a concise statement of the Regulations (CFR) Part 235 and 49 association, business, labor union, etc.). interest of the party in the proceeding. U.S.C. 20502(a), the following railroad You may review DOT’s complete Additionally, one copy of the protest has petitioned the Federal Railroad Privacy Act Statement in the Federal shall be furnished to the applicant at the Administration (FRA) seeking approval Register published on April 11, 2000 address listed above. for the discontinuance or modification (Volume 65, Number 70; Pages 19477– All communications concerning this of the signal system or relief from the 78) or you may visit http://dms.dot.gov. proceeding should be identified by the requirements of 49 CFR part 236 as FRA expects to be able to determine docket number and must be submitted detailed below. these matters without an oral hearing.

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However, if a specific request for an oral (Plaza Level), 400 7th Street, SW., soliciting comments on the following hearing is accompanied by a showing Washington, DC 20590–0001. collection of information was published that the party is unable to adequately Communications received within 45 on April 4, 2003. No comments were present his or her position by written days of the date of this notice will be received. statements, an application may be set considered by the FRA before final DATES: Comments must be submitted on for public hearing. action is taken. Comments received after or before July 18, 2003. that date will be considered as far as Issued in Washington, DC, on June 11, FOR FURTHER INFORMATION CONTACT: practicable. All written communications 2003. James Zok, maritime Administration concerning these proceedings are Grady C. Cothen, Jr., (MAR–500), 400 Seventh St., SW., available for examination during regular Deputy Associate Administrator for Safety Washington, DC 20590. Telephone: business hours (9 a.m.–5 p.m.) at the Standards and Program Development. 202–366–0364; FAX: 202–366–9580, or above facility. All documents in the [FR Doc. 03–15398 Filed 6–17–03; 8:45 am] e-mail: [email protected]. Copies public docket are also available for BILLING CODE 4910–06–P of this collection also can be obtained inspection and copying on the internet from that office. at the docket facility’s Web site at SUPPLEMENTARY INFORMATION: DEPARTMENT OF TRANSPORTATION http://dms.dot.gov. FRA wishes to inform all potential Maritime Administration (MARAD) Federal Railroad Administration commenters that anyone is able to search the electronic form of all Title: Customer Service Survey. Notice of Application for Approval of comments received into any of our OMB Control Number: 2133–0528. Discontinuance or Modification of a dockets by the name of the individual Type of Request: Extension of Railroad Signal System or Relief From submitting the comment (or signing the currently approved collection. the Requirements of Title 49 Code of comment, if submitted on behalf of an Affected Public: Individuals receiving Federal Regulations Part 236 association, business, labor union, etc.). goods and services from the Maritime You may review DOT’s complete Administration. Pursuant to Title 49 Code of Federal Privacy Act Statement in the Federal Forms: MA–1016, MA–1017, and Regulations (CFR) part 235 and 49 Register published on April 11, 2000 MA–1021. Abstract: Executive Order 12862 U.S.C. 20502(a), the following railroad (Volume 65, Number 70; Pages 19477– requires agencies to survey customers to has petitioned the Federal Railroad 78) or you may visit http://dms.dot.gov. Administration (FRA) seeking approval FRA expects to be able to determine determine the kind and quality of for the discontinuance or modification these matters without an oral hearing. services they want and the level of of the signal system or relief from the However, if a specific request for an oral satisfaction with existing services. This requirements of 49 CFR part 236 as hearing is accompanied by a showing collection provides the instruments detailed below. that the party is unable to adequately used to collect the information regarding MARDAD programs and Docket No. FRA–2003–15102 present his or her position by written statements, an application may be set services. Applicant: Norfolk Southern for public hearing. Annual Estimated Burden Hours: 256 Corporation, Mr. Brian L. Sykes, Chief hours. Issued in Washington, DC on June 11, Engineer C&S Engineering, 99 Spring ADDRESSES: Send comments to the 2003. Street, SW., Atlanta, Georgia 30303. Office of Information and Regulatory The Norfolk Southern Corporation Grady C. Cothen, Jr., Affairs, Office of Management and seeks approval of the proposed Deputy Associate Administrator for Safety Budget, 725 17th Street, NW., discontinuance and removal of the Standards and Program Development. Washington, DC 20503, Attention automatic block signal system, on the [FR Doc. 03–15396 Filed 6–17–03; 8:45 am] MARAD Desk Officer. two main tracks between Clair, New BILLING CODE 4910–06–P Comments are Invited on: (a) Whether Jersey, milepost 11.7 and DB-Junction, the proposed collection of information New Jersey, milepost 4.3, on the Orange is necessary for the proper performance Running Track, Harrisburg Division. DEPARTMENT OF TRANSPORTATION of the functions of the agency, including The proposal includes retention of the Maritime Administration whether the information will have interlocking signals at DB-Junction. practical utility; (b) the accuracy of the The reason given for the proposed Reports, Forms and Recordkeeping agency’s estimate of the burden of the changes is to eliminate facilities no Requirements; Agency Information proposed information collection; (c) longer needed for present day operation. Collection Activity Under OMB Review ways to enhance the quality, utility and Both tracks are only used for local clarity of the information to be access to the Orange Industry Track. AGENCY: Maritime Administration, DOT. collected; and (d) ways to minimize the Any interested party desiring to ACTION: Notice and request for burden of the collection of information protest the granting of an application comments. on respondents including the use of shall set forth specifically the grounds automated collection techniques or SUMMARY: upon which the protest is made, and In compliance with the other forms of information technology. include a concise statement of the Paperwork Reduction Act of 1995 (44 A comment to OMB is best assured of interest of the party in the proceeding. U.S.C. 3501 et seq.), this notice having its full effect if OMB receives it Additionally, one copy of the protest announces that the Information within 30 days of publication. shall be furnished to the applicant at the Collection abstracted below has been address listed above. forwarded to the Office of management Issued in Washington, DC on June 13, All communications concerning this and Budget (OMB) for review and 2003. proceeding should be identified by the approval. The nature of the information Joel C. Richard, docket number and must be submitted collection is described as well as its Secretary Maritime Administration. to the Docket Clerk, DOT Central Docket expected burden. The Federal Register [FR Doc. 03–15371 Filed 6–17–03; 8:45 am] Management Facility, Room PL–401 Notice with a 60-day comment period BILLING CODE 4910–81–M

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DEPARTMENT OF THE TREASURY Internal Revenue Service (IRS) Copying, assembling, and sending the OMB Number: 1545–0139. form to the IRS—34 min. Submission for OMB Review; Form Number: IRS Form 2106. Frequency of Response: Annually. Comment Request Type of Review: Revision. Estimated Total Reporting/ Title: Employee Business Expenses. Recordkeeping Burden: 22,809,519 June 10, 2003. Description: Internal Revenue Code hours. The Department of Treasury has (IRC) section 62 allows employees to submitted the following public deduct their business expenses to the OMB Number: 1545–0890. information collection requirement(s) to extent of reimbursement in computing Form Number: IRS Form 1120–A. OMB for review and clearance under the ‘‘Adjusted Gross Income’’. Expenses in Type of Review: Extension. Paperwork Reduction Act of 1995, Pub. excess of reimbursements are allowed as Title: U.S. Corporation Short-Form L. 104–13. Copies of the submission(s) an itemized deduction. Unreimbursed Income Tax Return. may be obtained by calling the Treasury meals and entertainment are allowed to Description: Form 1120–A is used by the extent of 50% of the expense. Form Bureau Clearance Officer listed. small corporations, those with less that 2106 is used to figure these expenses. $500,000 of income and assets, to Comments regarding this information Respondents: Individuals or collection should be addressed to the compute their taxable income and tax households. liability. The IRS uses Form 1120–A to OMB reviewer listed and to the Estimated Number of Respondents/ determine whether corporations have Treasury Department Clearance Officer, Recordkeepers: 5,567,188. Department of the Treasury, Room Estimated Burden Hours Per correctly computed their tax liability. 11000, 1750 Pennsylvania Avenue, Respondent/Recordkeeper: Respondents: Business or other for- NW., Washington, DC 20220. Recordkeeping—2 hr., 11 min. profit, Farms. Learning about the law or the form—27 Estimated Number of Respondents/ DATES: Written comments should be min. Recordkeepers: 191,769. received on or before July 18, 2003 to be Preparing and sending the form—1 hr., Estimated Burden Hours Per assured of consideration. 27 min. Respondent/Recordkeeper:

Copying, assem- Learning about the law or bling, and sending Form Recordkeeping the form Preparing the form the form to the IRS

1120 ...... 71 hr., 18 min ...... 43 hr., 29 min ...... 75 hr., 24 min ...... 8 hr., 18 min. 1120–A ...... 43 hr., 44 min ...... 23 hr., 6 min ...... 41 hr., 35 min ...... 4 hr., 49 min. Schedule D (1120) ...... 7 hr., 10 min ...... 4 hr., 6 min ...... 6 hr., 16 min ...... 32 min. Schedule H (1120) ...... 5 hr., 58 min ...... 35 min ...... 43 min ...... 0 min. Schedule N (1120) ...... 3 hr., 35 min ...... 1 hr., 7 min ...... 3 hr., 6 min ...... 32 min. Schedule PH (1120) ...... 15 hr., 18 min ...... 6 hr., 12 min ...... 8 hr., 35 min ...... 32 min.

Frequency of Response: Annually. Clearance Officer: Glenn Kirkland, information collection should be Estimated Total Reporting/ Internal Revenue Service, Room 6411– addressed to the OMB reviewer listed Recordkeeping Burden: 19,152,552 03, 1111 Constitution Avenue, NW, and to the Treasury Department hours. Washington, DC 20224, (202) 622–3428. Clearance Officer, Department of the OMB Number: 1545–1057. OMB Reviewer: Joseph F. Lackey, Jr., Treasury, Room 11000, 1750 Form Number: IRS Form 8800. Office of Management and Budget, Pennsylvania Avenue, NW., Type of Review: Extension. Room 10235, New Executive Office Washington, DC 20220. Title: Application for Additional Building, Washington, DC 20503, (202) DATES: Written comments should be Extension of Time to File U.S. Return 395–7316. received on or before July 18, 2003 to be for a Partnership, REMIC, or for Certain Mary A. Able, assured of consideration. Trusts. Departmental Reports Management Officer. Description: Form 8800 is used by Financial Management Service (FMS) [FR Doc. 03–15382 Filed 6–17–03; 8:45 am] partnerships, real estate mortgage OMB Number: 1510–0056. investment conduits (REMICs), and by BILLING CODE 4830–01–P Form Number: SF 3881. certain trusts to request an additional Type of Review: Extension. Title: ACH Vendor/Miscellaneous extension of time (up to 3 months) to DEPARTMENT OF THE TREASURY file Form 1065, Form 1041, or Form Payment Enrollment Form. 1066. Form 8800 contains data needed Submission for OMB Review; Description: Payment data will be by the IRS to determine whether or not Comment Request collected from vendors doing business a taxpayer qualifies for such an with the Federal Government. FMS/ extension. June 9, 2003. Treasury will use the information to Respondents: Business or other for- The Department of Treasury has electronically transmit payments to profit, Farms. submitted the following public vendors’ financial institutions. The Estimated Number of Respondents/ information collection requirement(s) to affected public includes (but not limited Recordkeepers: 20,000. OMB for review and clearance under the to) business, state/local governments, Estimated Burden Hours Per Paperwork Reduction Act of 1995, corporations, educational institutions, Respondent/Recordkeeper: 11 minutes. Public Law 104–13. Copies of the and other organizations. Frequency of Response: Annually. submission(s) may be obtained by Respondents: Business or other for- Estimated Total Reporting/ calling the Treasury Bureau Clearance profit, not-for-profit institutions, State, Recordkeeping Burden: 3,800 hours. Officer listed. Comments regarding this Local or Tribal Government.

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Estimated Number of Respondents: To be accepted by the Commission, Financial Institutions Fund, U.S. 70,000. final comments must not exceed a Department of the Treasury, 601 13th Estimated Burden Hours Per maximum length of 10 pages of double- Street, NW., Suite 200 South, Respondent: 15 minutes. spaced written text. Washington, DC 20005, Telephone Frequency of Response: On occasion. SUPPLEMENTARY INFORMATION: Please be Number (202) 622–8662, Facsimile Estimated Total Reporting Burden: aware that the Commission may, at its Number (202) 622–7754. 17,500 hours. discretion, post any final comments it SUPPLEMENTARY INFORMATION: Clearance Officer: Juanita Holder, receives on the Commission’s Web site Title: The Community Development Financial Management Service, 3700 at www.treas.gov/offices/domestic- Financial Institutions Fund—Conflict of East West Highway, Room 135, PGP finance/usps. Interest Package for Non-Federal II, Hyattsville, MD 20782. FOR FURTHER INFORMATION CONTACT: If Readers. OMB Reviewer: Joseph F. Lackey, Jr., you have any questions about this final- OMB Number: 1559–0011. (202) 395–7316, Office of comment process, please contact Jana Abstract: Through its programs the Management and Budget, Room Sinclair White or James Cox of the Fund supports financial institutions 10235, New Executive Office Commission staff at (202) 622–5930. around the country that are specifically Building, Washington, DC 20503. Dated: June 12, 2003. dedicated to financing and supporting community and economic development Mary A. Able, Roger Kodat, activities. This strategy builds strong Departmental Reports Management Officer. Designated Federal Official. institutions that make loans and [FR Doc. 03–15383 Filed 6–17–03; 8:45 am] [FR Doc. 03–15319 Filed 6–17–03; 8:45 am] investments and provide financial BILLING CODE 4810–35–P BILLING CODE 4811–16–P services in markets (including economically distressed investments areas and targeted populations) whose DEPARTMENT OF THE TREASURY DEPARTMENT OF THE TREASURY needs for loans, investments, and President’s Commission on the United Community Development Financial financial services have not been fully States Postal Service Institutions Fund met by traditional financial institutions, particularly in the areas of promoting AGENCY: Department of the Treasury, Proposed Collection; Comment homeownership, developing of Departmental Offices. Request affordable housing, and stimulating ACTION: Notice and request for small business development, as well as comments. ACTION: Notice and request for providing financial services to those comments. that have not previously accessed SUMMARY: Now that the Commission has financial institutions. SUMMARY: concluded the testimonial portion of its The Department of the Consistent with the Federal work, it will accept final written Treasury, as part of its continuing effort Acquisition Regulations provisions on comments from any party who wishes to to reduce paperwork and respondent conflicts of interest, the Fund has submit them for consideration. burden, invites the general public and applied, and will continue to apply, a The Commission has established three other Federal agencies to take this conflict of interest policy with respect to methods by which final comments can opportunity to comment on proposed its contract (non-Federal employee) be submitted for consideration and and/or continuing information readers that avoids a reader’s review: collections, as required by the participation in the evaluation or 1. Transmission by E-mail to the Paperwork Reduction Act of 1995, Pub. process of selection of applications following address: L. 104–13 (44 U.S.C. 3506(c)(2)(A)). where such participation creates a [email protected]. Statements Currently, the Community Development conflict of interest or an appearance of can be embedded in the E-mail as ASCII Financial Institutions Fund (the a conflict of interest. The conflict of text or sent as a MS Word or ASCII text ‘‘Fund’’) within the Department of the interest review materials are used by the attachment. Do not include artwork or Treasury is soliciting comments Fund to determine whether or not a other graphic elements. concerning the Fund’s conflict of contractor’s financial interest, or that of 1 interest reporting requirements for 2. Stored on 3 ⁄2 inch high density the contractor’s spouse, parent, computer disk as a MS word or ASCII contract readers of applications dependent child, or member of text document (Windows format only) submitted for funding under the Fund’s household, may result in a conflict, or and mailed or hand-delivered to: various programs. apparent conflict of interest with the President’s Commission on the United DATES: Written comments should be individual’s duties and responsibilities States Postal Service, 1120 Vermont received on or before August 18, 2003 as a contractor evaluating applications. Avenue, NW., Suite 971, Washington, to be assured of consideration. The completion of the package is DC 20005. ADDRESSES: Direct all comments to mandatory for all contractors prior to 3. Typewritten statements may be Jeffrey C. Berg, Legal Counsel, their selection as readers. mailed or hand-delivered to: President’s Community Development Financial Current Action: Extension. Commission on the United States Postal Institutions Fund, U.S. Department of Type of Review: Renewal. Service, 1120 Vermont Avenue, NW., the Treasury, 601 13th Street, NW., Affected Public: Individuals. Suite 971, Washington, DC 20005. Suite 200 South, Washington, DC 20005, Estimated Number of Respondents: DATES: E-mail transmissions of all final Facsimile Number (202) 622–7754. 80. comments must be received by the FOR FURTHER INFORMATION CONTACT: A Estimated Annual Time Per Commission no later than 5 p.m. eastern copy of the conflict of interest Respondent: 0.75 hours. standard time on Tuesday, July 8. information collection or requests for Estimated Total Annual Burden Mailed submissions must be additional information may be obtained Hours: 60 hours. postmarked no later than 5 p.m. eastern by contacting Jeffrey C. Berg, Legal Requests for Comments: Comments standard time on Tuesday, July 8. Counsel, Community Development submitted in response to this notice will

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be summarized and/or included in the Washington, DC 20005, Facsimile Fund, including whether the request for OMB approval. All Number (202) 622–7754. information shall have practical utility; comments will become a matter of FOR FURTHER INFORMATION CONTACT: The (b) the accuracy of the Fund’s estimate public record. Comments are invited on: Certification/Re-certification application of the burden of the collection of (a) Whether the collection of will be in the same form as the information; (c) ways to enhance the information is necessary for the proper Eligibility and Certification Materials quality, utility, and clarity of the performance of the functions of the section of the CDFI Program—Technical information to be collected; (d) ways to Fund, including whether the Assistance Component application minimize the burden of the collection of information shall have practical utility; (located at Part II, page 21), except that information on respondents, including (b) the accuracy of the Fund’s estimate questions under Subparts A and C will through the use of technology; and (e) of the burden of the collection of not be included in the stand-alone estimates of capital or start-up costs and information; (c) ways to enhance the Certification/Re-certification application costs of operation, maintenance, and quality, utility, and clarity of the and there will be no opportunities for purchase of services to provide information to be collected; (d) ways to applicants that do not meet a specific information. minimize the burden of the collection of certification requirement(s) to provide a Authority: 12 U.S.C. 4703, 4703 note, 4704, information on respondents, including narrative describing its proposal to meet 4706, 4707, 4717; 12 CFR part 1805. through the use of technology; and (e) such requirement(s).The Technical Dated: June 12, 2003. estimates of capital or start-up costs and Assistance Component application may Tony T. Brown, costs of operation, maintenance, and be obtained from the Fund’s Web site at purchase of services to provide http://www.cdfifund.gov. Requests for Director, Community Development Financial Institutions Fund. information. additional information should be [FR Doc. 03–15360 Filed 6–17–03; 8:45 am] Authority: 12 U.S.C. 4703(c); and 48 CFR directed to Linda G. Davenport, Deputy subpart 9.5. Director for Policy and Programs, BILLING CODE 4810–70–P Dated: June 11, 2003. Community Development Financial Institutions Fund, U.S. Department of Tony T. Brown, DEPARTMENT OF THE TREASURY the Treasury, 601 13th Street, NW., Director, Community Development Financial Suite 200 South, Washington, DC 20005, Institutions Fund. Internal Revenue Service or call (202) 622–8662. [FR Doc. 03–15359 Filed 6–17–03; 8:45 am] SUPPLEMENTARY INFORMATION: [REG–103805–99] BILLING CODE 4810–70–P Title: The Community Development Financial Institutions Program— Proposed Collection; Comment Certification/Re-Certification Request for Regulation Project DEPARTMENT OF THE TREASURY Application. OMB Number: 1559–0006. Community Development Financial AGENCY: Internal Revenue Service (IRS), Abstract: The purpose of the CDFI Treasury. Institutions Fund Program is to promote economic ACTION: revitalization and community Notice and request for Proposed Collection; Comment development through investment in and comments. Request assistance to certified CDFIs. Through SUMMARY: The Department of the ACTION: Notice and request for the CDFI Program, the Fund makes Treasury, as part of its continuing effort comments. financial investments in and may to reduce paperwork and respondent provide technical assistance grants to burden, invites the general public and SUMMARY: The Department of the CDFIs that have comprehensive other Federal agencies to take this Treasury, as part of its continuing effort business plans for creating opportunity to comment on proposed to reduce paperwork and respondent demonstrable community development and/or continuing information burden, invites the general public and impact through the deployment of collections, as required by the other Federal agencies to take this capital within their respective target Paperwork Reduction act of 1995, opportunity to comment on proposed markets for community development Public Law 104–13 (44 U.S.C. and/or continuing information finance purposes. In order to be certified 3506(c)(2)(A)). Currently, the IRS is collections, as required by the as a CDFI, an entity must submit an soliciting comments concerning an Paperwork Reduction Act of 1995, Pub. application for certification to the Fund. existing final regulation, REG–103805– L. 104–13 (44 U.S.C. 3506(c)(2)(A)). Type of Review: Extension. Affected Public: Not-for-profit 99 (TD 9002), Agent for Consolidated Currently, the Community Development Group (§ 1.1502–77). Financial Institutions Fund (the institutions, businesses or other for- ‘‘Fund’’) within the Department of the profit institutions and tribal entities. DATES: Written comments should be Treasury is soliciting comments Estimated Number of Respondents: received on or before August 6, 2003 to concerning the Community 215. be assured of consideration. Estimated Annual Time Per Development Financial Institutions ADDRESSES: Direct all written comments Respondent: 40 hours. (‘‘CDFI’’) Program; Certification/Re- Estimated Total Annual Burden to Glenn P. Kirkland, Internal Revenue certification Application. Hours: 8,600 hours. Service, room 6411, 1111 Constitution DATES: Written comments should be Requests for Comments: Comments Avenue NW., Washington, DC 20224. received on or before August 18, 2003 submitted in response to this notice will FOR FURTHER INFORMATION CONTACT: to be assured of consideration. be summarized and/or included in the Requests for additional information or ADDRESSES: Direct all comments to request for OMB approval. All copies of regulations should be directed Linda G. Davenport, Deputy Director for comments will become a matter of to Carol Savage at Internal Revenue Policy and Programs, Community public record. Comments are invited on: Service, room 6407, 1111 Constitution Development Financial Institutions (a) Whether the collection of Avenue NW., Washington, DC 20224, or Fund, U.S. Department of the Treasury, information is necessary for the proper at (202) 622–3945, or through the 601 13th Street, NW., Suite 200 South, performance of the functions of the internet at [email protected].

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SUPPLEMENTARY INFORMATION: Estimated Number of Respondents: matter of public record. Comments are Title: Agent for Consolidated Group. 100. invited on: (a) Whether the collection of OMB Number: 1545–1699. Estimated Time Per Respondent: 2 information is necessary for the proper Regulation Project Number: REG– hours. performance of the functions of the 103805–99. Estimated Total Annual Burden agency, including whether the Abstract: The information is needed Hours: 200. information shall have practical utility; in order for a terminating common The following paragraph applies to all (b) the accuracy of the agency’s estimate parent of a consolidated group to of the collections of information covered designate a substitute agent for the by this notice: of the burden of the collection of group and receive approval of the An agency may not conduct or information; (c) ways to enhance the Commissioner, or for a default sponsor, and a person is not required to quality, utility, and clarity of the substitute agent to notify the respond to, a collection of information information to be collected; (d) ways to Commissioner that it is the default unless the collection of information minimize the burden of the collection of substitute agent, pursuant to Treas. Reg. displays a valid OMB control number. information on respondents, including § 1.1502–77(d). The Commissioner will Books or records relating to a collection through the use of automated collection use the information to determine of information must be retained as long techniques or other forms of information whether to approve the designation of as their contents may become material technology; and (e) estimates of capital the substitute agent (if approval is in the administration of any internal or start-up costs and costs of operation, required) and to change the IRS’s revenue law. Generally, tax returns and maintenance, and purchase of services records to reflect the information about tax return information are confidential, to provide information. the substitute agent. as required by 26 U.S.C. 6103. Current Actions: There is no change to Approved: June 11, 2003. Request for Comments this existing regulation. Glenn P. Kirkland, Type of Review: Extension of a Comments submitted in response to IRS Reports Clearance Officer. currently approved collection. this notice will be summarized and/or [FR Doc. 03–15284 Filed 6–17–03; 8:45 am] Affected Public: Business or other for- included in the request for OMB BILLING CODE 4830–01–M profit organizations. approval. All comments will become a

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Part II

Securities and Exchange Commission 17 CFR Parts 210, 228, et al. Management’s Report on Internal Control Over Financial Reporting and Certification of Disclosure in Exchange Act Periodic Reports; Final Rule

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SECURITIES AND EXCHANGE 2002 as exhibits to certain periodic certifications to eliminate certain COMMISSION reports. references to internal control over DATES: Effective Date: August 14, 2003. financial reporting, as further explained 17 CFR Parts 210, 228, 229, 240, 249, Compliance Dates: The following in Section II.I. below. Registered 270 and 274 compliance dates apply to companies investment companies may voluntarily [Release Nos. 33–8238; 34–47986; IC– other than registered investment comply with the rule and form 26068; File Nos. S7–40–02; S7–06–03] companies. A company that is an amendments before the compliance ‘‘accelerated filer,’’ as defined in dates. RIN 3235–AI66 and 3235–AI79 Exchange Act Rule 12b–2, as of the end FOR FURTHER INFORMATION CONTACT: N. Management’s Report on Internal of its first fiscal year ending on or after Sean Harrison, Special Counsel, or Control Over Financial Reporting and June 15, 2004, must begin to comply Andrew D. Thorpe, Special Counsel, Certification of Disclosure in Exchange with the management report on internal Division of Corporation Finance, at Act Periodic Reports control over financial reporting (202) 942–2910, or with respect to disclosure requirements in its annual registered investment companies, AGENCY: Securities and Exchange report for that fiscal year. A company Christian Broadbent, Senior Counsel, Commission. that is not an accelerated filer as of the Division of Investment Management, at ACTION: Final rule. end of its first fiscal year ending on or (202) 942–0721, or with respect to after June 15, 2004, including a foreign attestation and auditing issues, Edmund SUMMARY: As directed by Section 404 of private issuer, must begin to comply Bailey, Assistant Chief Accountant, the Sarbanes-Oxley Act of 2002, we are with the annual internal control report Randolph P. Green, Professional adopting rules requiring companies for its first fiscal year ending on or after Accounting Fellow, or Paul Munter, subject to the reporting requirements of April 15, 2005. A company must begin Academic Accounting Fellow, Office of the Securities Exchange Act of 1934, to comply with the requirements the Chief Accountant, at (202) 942– other than registered investment regarding evaluation of any material 4400, U.S. Securities and Exchange companies, to include in their annual change to its internal control over Commission, 450 Fifth Street, NW., reports a report of management on the financial reporting in its first periodic Washington, DC 20549. company’s internal control over report due after the first annual report SUPPLEMENTARY INFORMATION: We are financial reporting. The internal control required to include a management revising Items 307, 401 and 601 of report must include: a statement of report on internal control over financial Regulations S–B 1 and S–K; 2 adding management’s responsibility for reporting. Companies may voluntarily new Item 308 to Regulations S–B and S– establishing and maintaining adequate comply with the new disclosure K; amending Form 10–K,3 Form 10– internal control over financial reporting requirements before the compliance KSB,4 Form 10–Q,5 Form 10–QSB,6 for the company; management’s dates. A company must comply with the Form 20–F,7 Form 40–F,8 Rule 12b–15,9 assessment of the effectiveness of the new exhibit requirements for the Rule 13a–14,10 Rule 13a–15,11 Rule company’s internal control over certifications required by Sections 302 15d–14 12 and Rule 15d–15 13 under the financial reporting as of the end of the and 906 of the Sarbanes-Oxley Act of Securities Exchange Act of 1934 (the company’s most recent fiscal year; a 2002 and changes to the Section 302 ‘‘Exchange Act’’); 14 amending Rules 1– statement identifying the framework certification requirements in its 02 and 2–02 15 of Regulation S–X; 16 used by management to evaluate the quarterly, semi-annual or annual report amending Rules 8b–15,17 30a–2 18 and effectiveness of the company’s internal due on or after August 14, 2003. To 30a–3 19 under the Investment Company control over financial reporting; and a account for the differences between the Act of 1940 (‘‘Investment Company statement that the registered public compliance date of the rules relating to Act’’); 20 and amending Forms N–CSR 21 accounting firm that audited the internal control over financial reporting and N–SAR 22 under the Exchange Act company’s financial statements and the effective date of changes to the and the Investment Company Act. included in the annual report has issued language of the Section 302 an attestation report on management’s certification, a company’s certifying Table of Contents assessment of the company’s internal officers may temporarily modify the I. Background control over financial reporting. Under content of their Section 302 the new rules, a company is required to certifications to eliminate certain 1 17 CFR 228.10 et seq. file the registered public accounting references to internal control over 2 17 CFR 229.10 et seq. firm’s attestation report as part of the financial reporting until the compliance 3 17 CFR 249.310. annual report. Furthermore, we are date, as further explained in Section 4 17 CFR 249.310b. adding a requirement that management III.E. below. 5 17 CFR 249.308a. 6 evaluate any change in the company’s Registered investment companies 17 CFR 249.308b. 7 17 CFR 249.220f. internal control over financial reporting must comply with the rule and form 8 17 CFR 249.240f. that occurred during a fiscal quarter that amendments applicable to them on and 9 17 CFR 240.12b–15. has materially affected, or is reasonably after August 14, 2003, except as follows. 10 17 CFR 240.13a–14. likely to materially affect, the Registered investment companies must 11 17 CFR 240.13a–15. company’s internal control over comply with the amendments to 12 17 CFR 140.15d–14. financial reporting. Finally, we are Exchange Act Rules 13a–15(a) and 15d– 13 17 CFR 240.15d–15. adopting amendments to our rules and 15(a) and Investment Company Act Rule 14 15 U.S.C. 78a et seq. forms under the Securities Exchange 30a–3(a) that require them to maintain 15 17 CFR 210.1–02 and 2–02. 16 Act of 1934 and the Investment internal control over financial reporting 17 CFR 210.1–01 et seq. 17 17 CFR 270.8b–15. Company Act of 1940 to revise the with respect to fiscal years ending on or 18 17 CFR 270.30a–2. Section 302 certification requirements after June 15, 2004. In addition, a 19 17 CFR 270.30a–3. and to require issuers to provide the registered investment company’s 20 15 U.S.C. 80a–1 et seq. certifications required by Sections 302 certifying officers may temporarily 21 17 CFR 249.331; 17 CFR 274.128. and 906 of the Sarbanes-Oxley Act of modify the content of their Section 302 22 17 CFR 249.330; 17 CFR 274.101.

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A. Management’s Report on Internal (the ‘‘Sarbanes-Oxley Act’’),23 which came from corporations, professional Control over Financial Reporting requires us to prescribe rules requiring associations, accountants, law firms, B. Certifications each annual report that a company, consultants, academics, investors and II. Discussion of Amendments Implementing other than a registered investment others. In general, the commenters Section 404 company,24 files pursuant to Section supported the objectives of the proposed A. Definition of Internal Control 1. Proposed Rule 13(a) or 15(d) of the Exchange Act to new requirements. Investors supported 2. Comments on the Proposal contain an internal control report: (1) the manner in which we proposed to 3. Final Rules Stating management’s responsibility for achieve these objectives and, in some B. Management’s Annual Assessment of, establishing and maintaining an cases, urged us to require additional and Report on, the Company’s Internal adequate internal control structure and disclosure from companies. Other Control over Financial Reporting procedures for financial reporting; and commenters, however, thought that we 1. Proposed Rule (2) containing an assessment, as of the were requiring more disclosure than 2. Comments on the Proposal end of the company’s most recent fiscal necessary to fulfill the mandates of the 3. Final Rules year, of the effectiveness of the Sarbanes-Oxley Act and suggested a. Evaluation of Internal Control over company’s internal control structure modifications to the proposals. We have Financial Reporting and procedures for financial reporting. reviewed and considered all of the b. Auditor Independence Issues c. Material Weaknesses in Internal Control Section 404 also requires every comments that we received on the over Financial Reporting registered public accounting firm that proposals. The adopted rules reflect d. Method of Evaluating prepares or issues an audit report on a many of these comments—we discuss e. Location of Management’s Report company’s annual financial statements our conclusions with respect to each C. Quarterly Evaluations of Internal to attest to, and report on, the topic and related comments in more Control over Financial Reporting assessment made by management. The detail throughout the release. 1. Proposed Rule attestation must be made in accordance B. Certifications 2. Comments on the Proposal with standards for attestation 3. Final Rules engagements issued or adopted by the We also are adopting amendments to D. Differences between Internal Control Public Company Accounting Oversight require companies to file the over Financial Reporting and Disclosure 25 certifications mandated by Sections 302 Controls and Procedures Board (‘‘PCAOB’’). Section 404 further E. Evaluation of Disclosure Controls and stipulates that the attestation cannot be and 906 of the Sarbanes-Oxley Act as Procedures the subject of a separate engagement of exhibits to annual, semi-annual and F. Periodic Disclosure about the Certifying the registered public accounting firm. quarterly reports. Section 302 required Officers’ Evaluation of the Company’s We received over 200 comment letters the Commission to adopt final rules that Disclosure Controls and Procedures and in response to our release proposing were to be effective by August 29, 2002, Disclosure about Changes to its Internal requirements to implement Sections under which the principal executive Control over Financial Reporting 404, 406 and 407 of the Sarbanes-Oxley and principal financial officers, or 1. Existing Disclosure Requirements Act.26 Of these, 61 respondents persons performing similar functions, of 2. Proposed Amendments to the Disclosure commented on the Section 404 a company filing periodic reports under Requirements proposals.27 These comment letters Section 13(a) or 15(d) of the Exchange 3. Final Disclosure Requirements 28 4. Conclusions Regarding Effectiveness of Act must provide a certification in Disclosure Controls and Procedures 23 Pub. L. 107–204, 116 Stat. 745 (2002). G. Attestation to Management’s Internal 24 Section 404 of the Sarbanes-Oxley Act does not Estate Investment Trusts; New York Bankers Control Report by the Company’s apply to any registered investment company due to Association; New York County Lawyers’ an exemption in Section 405 of the Sarbanes-Oxley Association; New York State Bar Association; Registered Public Accounting Firm Act. See sec. 405 of Pub. L. 107–204, 116 Stat. 745 Software & Information Industry Association; H. Types of Companies Affected (2002). Software Finance and Tax Executives Council; 1. Foreign Private Issuers 25 On April 25, 2003, the Commission approved Wisconsin Bankers Association; Corporations 2. Asset-Backed Issuers the PCAOB’s adoption of the auditing and Cardinal Health, Inc.; Compass Bancshares, Inc.; 3. Small Business Issuers attestation standards in existence as of April 16, Computer Sciences Corporation; Eastman Kodak 4. Bank and Thrift Holding Companies 2003 as interim auditing and attestation standards. Company; Eli Lilly and Company; Emerson Electric I. Registered Investment Companies See Release No. 33–8222 (Apr. 25, 2003) [68 FR Co.; Executive Responsibility Advisors, LLC; Greif Bros.; Intel Corporation; International Paper J. Transition Period 23335]. 26 Company; Protiviti; Government Entities Federal III. Discussion of Amendments Related to Release No. 33–8138 (Oct. 22, 2002) [67 FR 66208] (‘‘Proposing Release’’). The public Reserve Bank of Atlanta; Small Business Certifications comments we received can be viewed in our Public Administration; Law Firms Dykema Gossett PLLC; A. Proposed Rules Reference Room at 450 Fifth Street, NW, Karr Tuttle Campbell; Fried, Frank, Harris, Shriver B. Final Rules Washington, DC 20549, in File No. S7–40–02. and Jacobson; Sutherland, Asbill & Brennan LLP; C. Effect on Interim Guidance Regarding Public comments submitted by electronic mail are Individuals Thomas Damman; D. Scott Huggins; Filing Procedures available on our Web site, http://www.sec.gov. Tim J. Leech; Simon Lorne; Ralph Saul; Lee Squire; D. Form of Section 302 Certifications 27 The commenters on File No. S7–40–02 are as Robert J. Stuckey; Foreign Companies Siemens follows: Academics Paul Walker, Ph.D., CPA; Aktiengesellcraft; International Entities British E. Transition Period Bankers Association; British Embassy; Canadian IV. Paperwork Reduction Act Accounting Firms BDO Seidman, LLP; Deloitte & Touche LLP; Ernst & Young LLP; KPMG LLP; Bankers Association; Confederation of British V. Cost-Benefit Analysis PricewaterhouseCoopers LLP; Associations Industry; European Commission; Institute of VI. Effect on Efficiency, Competition and America’s Community Bankers; American Bankers Chartered Accountants of England and Wales. Capital Formation Association; American Bar Association; American 28 15 U.S.C. 78m(a) or 78o(d). Section 13(a) of the VII. Final Regulatory Flexibility Analysis Corporate Counsel Association; American Institute Exchange Act requires every issuer of a security VIII. Statutory Authority and Text of Rule of Certified Public Accountants; Association for registered pursuant to Section 12 of the Exchange Amendments Financial Professionals; the Association of the Bar Act [15 U.S.C. 78l] to file with the Commission such of the City of New York; Association for Investment annual reports and such quarterly reports as the I. Background Management and Research; the Business Commission may prescribe. Section 15(d) of the Roundtable; Community Bankers Association of Exchange Act requires each issuer that has filed a A. Management’s Report on Internal New York State; Edison Electric Institute; Financial registration statement that has become effective Control Over Financial Reporting Executives International; Independent Community pursuant to the Securities Act of 1933 [15 U.S.C. Bankers of America; the Institute of Internal 77a et seq.] (the ‘‘Securities Act’’) to file such Auditors; Maine Bankers Association; supplementary and periodic information, In this release, we implement Section Manufacturers Alliance/MAPI Inc.; Massachusetts documents and reports as may be required pursuant 404 of the Sarbanes-Oxley Act of 2002 Bankers Association; National Association of Real Continued

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each quarterly and annual report filed effectively monitor compliance with tests of transactions and perform with the Commission. Section 906 of the this certification requirement. additional analyses in order to Sarbanes-Oxley Act added new Section accumulate sufficient, competent audit II. Discussion of Amendments 1350 to Title 18 of the United States evidence to support its opinion on the Implementing Section 404 Code,29 which contains a certification financial statements. requirement subject to specific federal A. Definition of Internal Control From the outset, it was recognized criminal provisions and that is separate that internal control is a broad concept 1. Proposed Rule and distinct from the certification that extends beyond the accounting requirement mandated by Section 302.30 The proposed rules would have functions of a company. Early attempts On August 28, 2002, we adopted defined the term ‘‘internal controls and to define the term focused primarily on Exchange Act Rules 13a-14 and 15d-14 procedures for financial reporting’’ 35 to clarifying the portion of a company’s and Investment Company Act Rule 30a- mean controls that pertain to the internal control that an auditor should 2 and amended our periodic report preparation of financial statements for consider when planning and performing forms to implement the statutory external purposes that are fairly an audit of a company’s financial directive in Section 302.31 These rules presented in conformity with generally statements.38 However, this did not and amendments became effective on accepted accounting principles as improve the level of understanding of August 29, 2002. On January 27, 2003, addressed by the Codification of the term, nor satisfactorily provide the we adopted Form N–CSR to be used by Statements on Auditing Standards § 319 guidance sought by auditors. Successive registered management investment or any superseding definition or other definitions and formal studies of the companies to file certified shareholder literature that is issued or adopted by concept of internal control followed. reports with the Commission.32 The the Public Company Accounting In 1977, based on recommendations provisions added to Title 18 by Section Oversight Board. of the Commission, Congress enacted 906 were by their terms effective on As noted in the Proposing Release, the Foreign Corrupt Practices Act enactment of the Sarbanes-Oxley Act. there has been some confusion over the (‘‘FCPA’’).39 The FCPA codified the To enhance the ability of interested exact meaning and scope of the term accounting control provisions contained parties to effectively access the ‘‘internal control,’’ because the in Statement of Auditing Standards No. certifications through our Electronic definition of the term has evolved over 1 (codified as AU § 320 in the Data Gathering, Analysis and Retrieval time. Historically, the term ‘‘internal Codification of Statements on Auditing (‘‘EDGAR’’) system and thereby enhance control’’ was applied almost exclusively Standards). Under the FCPA, companies compliance with the certification within the accounting profession.36 As that have a class of securities registered requirements, we proposed to amend the auditing of financial statements under Section 12 of the Exchange Act, our rules and forms to require a evolved from a process of detailed or that are required to file reports under company to file the certifications as an testing of transactions and account Section 15(d) of the Exchange Act, are exhibit to the periodic reports to which balances towards a process of sampling required to devise and maintain a they relate.33 The proposals addressed and testing, greater consideration of a both Section 302 and 906 certifications. company’s internal controls became 38 An early definition for the term appeared in After discussions with the Department 37 Internal Control—Elements Of a Coordinated necessary in planning an audit. If an System and Its Importance to Management and the of Justice, we concluded that, in light of internal control component had been Independent Public Accountant, a report published the inconsistent methods that adequately designed, then the auditor in 1949 by the American Institute of Accountants, companies have been employing to could limit further consideration of that the predecessor to the American Institute of fulfill their obligations under Section control to procedures to determine Certified Public Accountants (‘‘AICPA’’). The report 34 defined internal control to mean ‘‘the plan of 906, an exhibit requirement would whether the control had been placed in organization and all of the coordinate methods and consistently enable investors and the operation. Accordingly, the auditor measures adopted within a business to safeguard its Commission staff, as well as the could rely on the control to serve as a assets, check the accuracy and reliability of its Department of Justice, to more accounting data, promote operational efficiency, basis to reduce the amount, timing or and encourage adherence to prescribed managerial extent of substantive testing in the policies.’’ Subsequent definitions of the term to Section 13 in respect of a security registered execution of an audit. Conversely, if an attempted to clarify the distinction by labeling the pursuant to Section 12, unless the duty to file under auditor determined that an internal controls relevant to an audit as ‘‘internal accounting Section 15(d) has been suspended for any fiscal controls’’ and the non-accounting controls as year. See Exchange Act Rule 12h-3 [17 CFR control component was inadequate in ‘‘administrative controls.’’ The AICPA officially 240.12h-3]. its design or operation, then the auditor dropped these distinctions in 1988. See Root, at p. 29 29 18 U.S.C. 1350. could not rely upon that control. In this 76. 30 See Release No. 34–46300 (Aug. 2, 2002) [67 FR instance, the auditor would conduct 39 Title I of Pub. L. 95–213 (1977). Beginning in 51508] at n. 11, containing supplemental 1973, as a result of the work of the Office of the information on the Commission’s original Watergate Special Prosecutor, the Commission certification proposal in light of the enactment of 35 We proposed to use this term throughout the became aware of a pattern of conduct involving the the Sarbanes-Oxley Act of 2002. rules implementing the annual internal control use of corporate funds for illegal domestic political 31 See Release No. 33–8124 (Aug. 28, 2002) [67 FR report requirements of Section 404 of the Sarbanes- contributions. A subsequent Commission 57276]. Oxley Act, as well as the revised Sarbanes-Oxley investigation revealed that instances of undisclosed 32 See Release No. IC–25914 (Jan. 27, 2003) [68 FR Section 302 certification requirements, to questionable or illegal corporate payments—both 5348]. complement the defined term ‘‘disclosure controls domestic and foreign—were widespread. On May 33 See Release No. 33–8212 (Mar. 21, 2003) [68 FR and procedures’’ referred to in the Section 302 12, 1976, the Commission submitted to the Senate 15600]. requirements. Congress used the term ‘‘internal Banking, Housing and Urban Affairs Committee a 34 These methods have included: (1) Submitting controls’’ in Section 302 and ‘‘internal control report entitled Report on Questionable and Illegal the statement as non-public paper correspondence; structure and procedures for financial reporting’’ in Corporate Payments and Practices. The report (2) submitting the statement as non-public Section 404. described and analyzed the Commission’s electronic correspondence with the EDGAR filing of 36 For a history of the development of internal investigation concerning improper corporate the periodic report; (3) submitting the statement control standards, see Steven J. Root, Beyond payments and outlined legislative and other under (1) or (2) above supplemented by an Item 9 COSO—Internal Control to Enhance Corporate responses that the Commission recommended to Form 8-K report so that the statement is publicly Governance (1998). remedy these problems. One of the Commission’s available; (4) submitting the statement as an exhibit 37 In 1941, the Commission adopted amendments recommendations was that Congress enact to the periodic report; and (5) submitting the to Rules 2–02 and 3–07 of Regulation S-X that legislation aimed expressly at enhancing the statement in the text of the periodic report formally codified this practice. See Accounting accuracy of the corporate books and records and the (typically, below the signature block for the report). Series Release No. 21 (Feb. 5, 1941) [11 FR 10921]. reliability of the audit process.

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system of internal accounting controls effected by an entity’s board of Several of the commenters that were sufficient to provide reasonable directors, management and other opposed to the proposed definition assurances that: personnel, designed to provide thought that we should refer to COSO • transactions are executed in reasonable assurance regarding the for the definition of internal control, accordance with management’s general achievement of objectives’’ in three rather than AU § 319.46 Some of these or specific authorization; categories—effectiveness and efficiency commenters noted that the objective of • transactions are recorded as of operations; reliability of financial AU § 319 is to provide guidance to necessary (1) to permit preparation of reporting; and compliance with auditors regarding their consideration of financial statements in conformity with applicable laws and regulations. COSO internal control in planning and generally accepted accounting further stated that internal control performing an audit of financial principles or any other criteria consists of: the control environment, statements. The common concern of applicable to such statements, and (2) to risk assessment, control activities, these commenters was that AU § 319 maintain accountability for assets; information and communication, and does not provide any measure or • access to assets is permitted only in monitoring. The scope of internal standard by which a company’s accordance with management’s general control therefore extends to policies, management can determine that internal or specific authorization; and control is effective, nor does it define • plans, procedures, processes, systems, the recorded accountability for activities, functions, projects, initiatives, what constitutes effective internal assets is compared with the existing and endeavors of all types at all levels control. One commenter believed that assets at reasonable intervals and of a company. absent such evaluative criteria or appropriate action is taken with respect definition of effectiveness, the proposed 40 In 1995, the AICPA incorporated the to any differences. rules could not be implemented definition of internal control set forth in In 1985, a private-sector initiative effectively.47 In addition, several of the the COSO Report in Statement on known as the National Commission on commenters opposed to the proposed Auditing Standards No. 78 (codified as Fraudulent Financial Reporting, also definition suggested that we use the AU § 319 in the Codification of known as the Treadway Commission, term ‘‘internal control over financial Statements on Auditing Standards).43 was formed to study the financial reporting’’ rather than the term ‘‘internal reporting system in the United States. In Although we recognized that the AU controls and procedures for financial 1987, the Treadway Commission issued § 319 definition was derived from the reporting,’’48 on the ground that the a report recommending that its COSO definition, our proposal referred former is more consistent with the sponsoring organizations work together to AU § 319 because we thought that the terminology currently used within the to integrate the various internal control former constituted a more formal and auditing literature. concepts and definitions and to develop widely-accessible version of the A few of the commenters urged us to a common reference point. definition than the latter. adopt a considerably broader definition In response, the Committee of 2. Comments on the Proposal of internal control that would focus not Sponsoring Organizations of the only on internal control over financial Treadway Commission (‘‘COSO’’) 41 We received comments from 25 reporting, but also on internal control undertook an extensive study of internal commenters on the proposed definition objectives associated with enterprise control to establish a common definition of ‘‘internal control and procedures for risk management and corporate that would serve the needs of financial reporting.’’ Eleven commenters governance. While we agree that these companies, independent public stated that the proposed definition of are important objectives, the definition accountants, legislators and regulatory internal control was appropriate or that we are adopting retains a focus on agencies, and to provide a broad generally agreed with the proposal.44 financial reporting, consistent with our framework of criteria against which Two of these noted that the definition position articulated in the Proposing companies could evaluate the in AU § 319 had been adopted by the Release. We are not adopting a more effectiveness of their internal control bank regulatory agencies for use by expansive definition of internal control systems. In 1992, COSO published its banking institutions.45 Fourteen of the for a variety of reasons. Most important, Internal Control—Integrated 25 commenters opposed the proposed we believe that Section 404 focuses on Framework.42 The COSO Framework definition. Two of these asserted that the element of internal control that defined internal control as ‘‘a process, the proposed definition was too relates to financial reporting. In complex and would not resolve the addition, many commenters indicated 40 See Exchange Act Section 13(b)(2) [15 U.S.C. confusion that existed over the meaning that even the more limited definition 78m(b)(2)]. or scope of the term. related to financial reporting that we 41 The Treadway Commission was sponsored by proposed will impose substantial the AICPA, the American Accounting Association, the Financial Executives International (formerly 43 Auditing Standards Board, AICPA, Statement reporting and cost burdens on Financial Executives Institute), the Institute of on Auditing Standards No. 78, Consideration of companies. Finally, independent Internal Auditors and the Institute of Management Internal Control in a Financial Statement Audit: An accountants traditionally have not been Accountants (formerly the National Association of Amendment to Statement on Auditing Standards responsible for reviewing and testing, or Accountants). The Treadway Commission’s report, No. 55 (1995). the Report of the National Commission on 44 See letters regarding File No. S7–40–02 of: attesting to an assessment by Fraudulent Financial Reporting (Oct. 1987), is America’s Community Bankers (‘‘ACB’’); American management of, internal controls that available at www.coso.org. Corporate Counsel Association (‘‘ACCA’’); 42 See COSO, Internal Control—Integrated American Institute of Certified Public Accountants 46 See letters regarding File No. S7–40–02 of: the Framework (1992) (‘‘COSO Report’’). In 1994, COSO (‘‘AICPA’’); Compass Bancshares, Inc. (‘‘Compass’’); American Bar Association, Committee on the published an addendum to the Reporting to Computer Sciences Corporation (‘‘CSC’’); the Federal Regulation of Securities and the Committee External Parties volume of the COSO Report. The Edison Electric Institute (‘‘EEI’’); the Independent on Law and Accounting (‘‘ABA’’); the Federal addendum discusses the issue of, and provides a Community Bankers of America (‘‘ICBA’’); the Reserve Bank of Atlanta (‘‘FED’’); IIA; Simon Lorne vehicle for, expanding the scope of a public Institute of Internal Auditors (‘‘IIA’’); the (‘‘Lorne’’); and Pricewaterhouse Coopers LLP management report on internal control to address Association of the Bar of the City of New York, (‘‘PwC’’). additional controls pertaining to safeguarding of Committee on Corporate Law (‘‘NYCB–CCL’’); 47 See ABA letter regarding File No. S7–40–02. assets. In 1996, COSO issued a supplement to its Protiviti; and Siemens AG. 48 See letters regarding File No. S7–40–02 of: original framework to address the application of 45 See letters regarding File No. S7–40–02 of ACB AICPA; Compass; Deloitte & Touche LLP (‘‘D&T’’); internal control over financial derivative activities. and ICBA. IIA; KPMG LLP (‘‘KPMG’’); and PwC.

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are outside the boundary of financial (2) Provide reasonable assurance that language is included to make clear that reporting. transactions are recorded as necessary to the assessment of management in its permit preparation of financial statements in internal control report as to which the 3. Final Rules accordance with generally accepted accounting principles, and that receipts and company’s registered public accounting After consideration of the comments, firm will be required to attest and report we have decided to make several expenditures of the registrant are being made only in accordance with authorizations of specifically covers the matters modifications to the proposed management and directors of the registrant; referenced in Section 103. A few amendments. We agree that we should and commenters believed that it would use the term ‘‘internal control over (3) Provide reasonable assurance regarding financial reporting’’ in our amendments prevention or timely detection of cause confusion if the definition of to implement Section 404, as well as our unauthorized acquisition, use or disposition internal control did not acknowledge revisions to the Section 302 certification of the registrant’s assets that could have a the objectives set forth in Section 103 of 51 requirements and forms of material effect on the financial statements. the Sarbanes-Oxley Act. As discussed in certification.49 Rapidly changing We recognize that our definition of Section II.G below, the PCAOB is terminology has been one obstacle in the term ‘‘internal control over financial responsible for establishing the Section the development of an accepted reporting’’ reflected in the final rules 103 standards. understanding of internal control. The encompasses the subset of internal Our definition also includes, in clause term ‘‘internal control over financial controls addressed in the COSO Report (3), explicit reference to assurances reporting’’ is the predominant term used that pertains to financial reporting regarding use or disposition of the by companies and auditors and best objectives. Our definition does not company’s assets. This provision is encompasses the objectives of the encompass the elements of the COSO specifically included to make clear that, Sarbanes-Oxley Act. In addition, by Report definition that relate to for purposes of our definition, the effectiveness and efficiency of a using this term, we avoid having to safeguarding of assets is one of the company’s operations and a company’s familiarize investors, companies and elements of internal control over compliance with applicable laws and auditors with new terminology, which financial reporting and it addresses the regulations, with the exception of should lessen any confusion that may supplementation of the COSO exist about the meaning and scope of compliance with the applicable laws Framework after it was originally internal control. and regulations directly related to the The final rules define ‘‘internal preparation of financial statements, promulgated. In the absence of our control over financial reporting’’ as: such as the Commission’s financial change to the definition, the 52 determination of whether control A process designed by, or under the reporting requirements. Our definition supervision of, the registrant’s principal is consistent with the description of regarding the safeguarding of assets falls executive and principal financial officers, or internal accounting controls in within a company’s internal control persons performing similar functions, and Exchange Act Section 13(b)(2)(B).53 over financial reporting currently could effected by the registrant’s board of Following the general language be subject to varying interpretation. directors,50 management and other defining internal control over financial Safeguarding of assets had been a personnel, to provide reasonable assurance reporting, clauses (1) and (2) include the regarding the reliability of financial reporting primary objective of internal accounting and the preparation of financial statements internal control matters described in control in SAS No. 1. In 1988, the ASB for external purposes in accordance with Section 103 of the Sarbanes-Oxley Act issued Statement of Auditing Standards that the company’s registered public generally accepted accounting principles and No. 55 (codified as AU § 319 in the includes those policies and procedures that: accounting firm is required to evaluate Codification of Statements on Auditing (1) Pertain to the maintenance of records in its audit or attestation report.54 This that in reasonable detail accurately and fairly Standards), which replaced AU § 320. reflect the transactions and dispositions of 51 See amended Exchange Act Rules 13a–14(d) SAS No. 55 revised the definition of the assets of the registrant; and 15d–14(d). The scope of the term ‘‘preparation ‘‘internal control’’ and expanded of financial statements in accordance with generally auditors’ responsibilities for considering 49 See new Item 308 of Regulations S–K and S– accepted accounting principles’’ in the definition internal control in a financial statement B, amended Items 1–02 and 2–02 of Regulation S– encompasses financial statements prepared for X; amended Items 307and 401 of Regulations S–K regulatory reporting purposes. audit. The prior classification of internal and S–B; amended Exchange Act Rules 13a–14, 52 Codification of Statements on Auditing control into the two categories of 13a–15, 15d–14 and 15d–15; and amended Forms Standards Section 317 requires auditors to consider ‘‘internal accounting control’’ and a company’s compliance with laws and regulations 20–F and 40–F. ‘‘administrative control’’ was replaced 50 The COSO Report states that the composition that have a direct and material effect on the of a company’s board and audit committee, and financial statements. with the single term ‘‘internal control how the directors fulfill their responsibilities 53 15 U.S.C. 78m(b)(2)(B). structure,’’ which consisted of three related to the financial reporting process, are key 54 Section 103 of the Sarbanes-Oxley Act requires interrelated components—control aspects of the company’s control environment. An the PCAOB to establish by rule standards to be used important element of the company’s internal by registered public accounting firms in the environment, the accounting system and control over financial reporting ‘‘* * * is the preparation and issuance of audit reports. In control procedures. Under this new involvement of the board or audit committee in carrying out this responsibility, the PCAOB must overseeing the financial reporting process, include in the auditing standards that it adopts, preparation of financial statements in accordance including assessing the reasonableness of among other things: a requirement that each with generally accepted accounting principles, and management’s accounting judgments and estimates registered public accounting firm describe in each that receipts and expenditures of the company are and reviewing key filings with regulatory agencies.’’ audit report the scope of its testing of the being made only in accordance with the See COSO Report at 130. The Commission similarly company’s internal control structure and authorization of management and directors of the has stated in the past that both a company’s procedures performed in fulfilling its internal company. In the audit report (or attestation report), management and board have important roles to play control evaluation and reporting required by in establishing a supportive control environment. In Section 404(b) of the Sarbanes-Oxley Act; present the registered public accounting firm also must its 1981 Statement of Policy regarding the FCPA, in the audit report (or attestation report) its findings describe, at a minimum, material weaknesses in the Commission stated, ‘‘In the last analysis, the key from such testing; and an evaluation of whether the such internal controls and any material to an adequate ’control environment’ is an approach company’s internal control structure and noncompliance found on the basis of such testing. on the part of the board and top management which procedures: (1) Include maintenance of records that See Sections 103(a)(2)(A)(iii)(I), (II) and (III) of the makes clear what is expected and that conformity in reasonable detail accurately and fairly reflect the Sarbanes-Oxley Act. See also, Interim Professional to these expectations will be rewarded while transactions and dispositions of the company’s Attestation Standards Rule 3300T, adopted in breaches will be punished.’’ See Release No. 34– assets; and (2) provide reasonable assurance that PCAOB Release No. 2003–006 (Apr. 18, 2003), and 17500 (Jan. 29, 1981) [46 FR 11544]. transactions are recorded as necessary to permit approved by the Commission on April 25, 2003.

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definition, the safeguarding of assets addendum, COSO concluded that while management’s evaluation of those was no longer a primary objective, but it believed its definition of internal controls and procedures; and a subset of the control procedures control in its 1992 report remained • A statement that the registered component.55 The COSO Report appropriate, it recognized that the FCPA public accounting firm that prepared or followed this shift in the iteration of encompasses certain controls related to issued the company’s audit report safeguarding of assets. The COSO safeguarding of assets and that there is relating to the financial statements Report states that operations objectives a reasonable expectation on the part of included in the company’s annual ‘‘pertain to effectiveness and efficiency some readers of management’s internal report has attested to, and reported on, of the entity’s operations, including control reports that the reports will management’s evaluation of the performance and profitability goals and cover such controls. The addendum company’s internal controls and safeguarding resources against loss.’’ 56 therefore sets forth the following procedures for financial reporting. However, the report also clarifies that definition of the term ‘‘internal control The proposed amendments did not list safeguarding of assets can fall within over safeguarding of assets against any additional disclosure requirements other categories of internal control.57 unauthorized acquisition, use or for the management report, but rather In 1994, COSO published an disposition’’: would have afforded management the addendum to the Reporting to External flexibility to tailor the report to fit its Internal control over safeguarding of assets company’s particular circumstances. Parties volume of the COSO Report. The against unauthorized acquisition, use or addendum was issued in response to a disposition is a process, effected by an 2. Comments on the Proposal concern expressed by some parties, entity’s board of directors, management and We received comments from 17 including the U.S. General Accounting other personnel, designed to provide commenters on our proposed annual Office, that the management reports reasonable assurance regarding prevention or internal control report requirements. All contemplated by the COSO Report did timely detection of unauthorized acquisition, of these commenters believed, in not adequately address controls relating use or disposition of the entity’s assets that could have a material effect on the financial varying degrees, that we should set forth to safeguarding of assets and therefore statements. additional disclosure criteria or would not fully respond to the standards for the management report. requirements of the FCPA.58 In the As indicated above, to achieve the desired result and to provide Nine commenters stated that we should 55 Control procedures were described as policies consistency with COSO’s 1994 provide guidance as to the topics to be and procedures in addition to the control addendum, we have incorporated this addressed in the management report, or environment and accounting system that definition into our definition of specify standards or a common set of management established to provide reasonable internal control objectives to be assurance that specific entity objectives will be ‘‘internal control over financial achieved. SAS 55 also states that control procedures reporting.’’ We are persuaded that this considered by management when may generally be categorized as procedures that is appropriate given the fact that our assessing the effectiveness of its include, among other things, ‘‘adequate safeguards definition will be used for purposes of company’s internal control over over access to and use of assets and records, such financial reporting to ensure that control as secured facilities and authorization for access to public management reporting, and that computer programs and data files.’’ See Statement the companies that will be subject to the objectives are addressed in a consistent 59 on Auditing Standards No. 55, paragraph no. 11. Section 404 requirements also are fashion. These commenters believed 56 See COSO ‘‘Addendum to Reporting to subject to the FCPA requirements. So, that consistent standards for External Parties,’’ Internal Control—Integrated under the final rules, safeguarding of management’s report on internal control Framework, (1994) (‘‘1994 Addendum’’) at p. 154. would help investors to understand and 57 The COSO Report states: ‘‘Although these assets as provided is specifically [objectives relating to safeguarding of resources] are included in our definition of ‘‘internal compare the quality of various primarily operations objectives, certain aspects of control over financial reporting.’’ management internal control reports. safeguarding can fall under other categories * * * Several commenters also thought that [T]he goal of ensuring that any such asset losses are B. Management’s Annual Assessment we should require management’s properly reflected in the entity’s financial of, and Report on, the Company’s internal control report to include certain statements represents a financial reporting objective.’’ The category in which an objective falls Internal Control Over Financial recitations that would parallel can sometimes depend on the circumstances. Reporting recitations that the registered public Continuing the discussion of safeguarding of assets, 1. Proposed Rule accounting firm would have to make in controls to prevent theft of assets—such as its report attesting to management’s maintaining a fence around inventory and a We proposed to amend Item 307 of 60 gatekeeper verifying proper authorization of assessment. Additional commenters requests for movement of goods—fall under the Regulations S–K and S–B, as well as believed that the management report on operations category. These controls normally would Forms 20–F and 40–F, to require a internal control should specifically not be relevant to the reliability of financial company’s annual report to include an reference the objectives contained in statement preparation, because any inventory losses internal control report of management would be detected pursuant to periodic physical Section 103 of the Sarbanes-Oxley inspection and recorded in the financial statements. containing: Act.61 Furthermore, although Section • However, if for financial reporting purposes A statement of management’s 404(b) of the Sarbanes-Oxley Act does management relies solely on perpetual inventory responsibility for establishing and not explicitly direct us to require records, as may be the case for interim reporting, maintaining adequate internal controls the physical security controls would then also fall companies to file the registered public within the financial reporting category. This is and procedures for financial reporting; accounting firms’ attestation reports as • because these physical security controls, along with The conclusions of management part of the companies’ annual report other controls over the perpetual inventory records, about the effectiveness of the company’s filings, we proposed a filing would be needed to ensure reliable financial internal controls and procedures for reporting. Id. at 37. 58 As stated in n. 1 to the 1994 Addendum, the financial reporting based on 59 See letters regarding File No. S7–40–02 of: FCPA requires companies, among other things, to ABA; CSC; EEI; FED; Eastman Kodak Co. ‘‘devise and maintain a system of internal assets; (iii) access to assets is permitted only in (‘‘Kodak’’); KPMG; Protiviti; and PwC. accounting controls sufficient to provide reasonable accordance with management’s general or specific 60 See letters regarding File No. S7–40–02 of: assurances that (i) transactions are executed in authorization; and (iv) the recorded accountability ACCA and Financial Executives Institute (‘‘FEI’’). accordance with management’s general or specific for assets is compared with the existing assets at 61 See letters regarding File No. S7–40–02 of: authorization; (ii) transactions are recorded as reasonable intervals and appropriate action is taken AICPA; BDO Seidman, LLP (‘‘BDO’’); D&T; Ernst & necessary * * * to maintain accountability for with respect to any differences.’’ Young LLP (‘‘E&Y’’); KPMG; and PwC.

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requirement that most of those report of the registered public benefits to investors. The use of commenting on this aspect of the accounting firm that audited the standard measures that are publicly proposal supported. company’s financial statements. available will enhance the quality of the internal control report and will promote 3. Final Rules a. Evaluation of Internal Control Over comparability of the internal control Financial Reporting After evaluating the comments reports of different companies. The final received, we are adopting the proposals In the Proposing Release, we rules require management’s report to with several modifications. The final requested comment on whether we identify the evaluation framework used rules require a company’s annual report should establish specific evaluative by management to assess the to include an internal control report of criteria for management’s report on effectiveness of the company’s internal management that contains: internal control. All of the commenters control over financial reporting.68 • A statement of management’s responding to this request supported the Specifically, a suitable framework responsibility for establishing and establishment of such evaluative criteria must: be free from bias; permit maintaining adequate internal control in order to improve comparability reasonably consistent qualitative and over financial reporting for the among the standards used by companies quantitative measurements of a company; to conduct their annual internal control company’s internal control; be • A statement identifying the evaluations.65 Several commenters sufficiently complete so that those framework used by management to believed that we either should adopt the relevant factors that would alter a conduct the required evaluation of the COSO Framework as the means by conclusion about the effectiveness of a effectiveness of the company’s internal which management must evaluate its company’s internal controls are not control over financial reporting; company’s internal control over omitted; and be relevant to an • Management’s assessment of the financial reporting or, alternatively, evaluation of internal control over effectiveness of the company’s internal simply acknowledge the COSO financial reporting.69 control over financial reporting as of the Framework as being suitable for end of the company’s most recent fiscal purposes of management’s evaluation. b. Auditor Independence Issues year, including a statement as to Other commenters suggested that we Because the auditor is required to whether or not the company’s internal require management to evaluate the attest to management’s assessment of control over financial reporting is effectiveness of a company’s internal internal control over financial reporting, effective.62 The assessment must control over financial reporting using management and the company’s include disclosure of any ‘‘material suitable control criteria established by a independent auditors will need to weaknesses’’ 63 in the company’s group that follows due process coordinate their processes of internal control over financial reporting procedures. documenting and testing the internal identified by management. Management After consideration of the comments, controls over financial reporting. is not permitted to conclude that the we have modified the final requirements However, we remind companies and company’s internal control over to specify that management must base their auditors that the Commission’s financial reporting is effective if there its evaluation of the effectiveness of the rules on auditor independence prohibit are one or more material weaknesses in company’s internal control over an auditor from providing certain the company’s internal control over financial reporting on a suitable, nonaudit services to an audit client.70 financial reporting; and recognized control framework that is As the Commission stated in its auditor • A statement that the registered established by a body or group that has independence release, auditors may public accounting firm that audited the followed due-process procedures, assist management in documenting financial statements included in the including the broad distribution of the internal controls. When the auditor is annual report has issued an attestation framework for public comment.66 engaged to assist management in report on management’s assessment of The COSO Framework satisfies our documenting internal controls, the registrant’s internal control over criteria and may be used as an management must be actively involved financial reporting.64 evaluation framework for purposes of in the process. We understand the need As proposed, our final rules also require management’s annual internal control for coordination between management a company to file, as part of the evaluation and disclosure requirements. and the auditor, however, we remind company’s annual report, the attestation However, the final rules do not mandate companies and auditors that use of a particular framework, such as management cannot delegate its 62 Management must state whether or not the the COSO Framework, in recognition of responsibility to assess its internal company’s internal control over financial reporting the fact that other evaluation standards controls over financial reporting to the is effective. A negative assurance statement 67 auditor.71 The rules adopted today do indicating that nothing has come to management’s exist outside of the United States, and attention to suggest that the company’s internal that frameworks other than COSO may control over financial reporting is not effective will be developed within the United States 68 We are aware that some of the evaluation not be acceptable. in the future, that satisfy the intent of frameworks used to assess a foreign company’s 63 internal controls in its home country do not require A ‘‘material weakness’’ is defined in Statement the statute without diminishing the on Auditing Standards No. 60 (codified in a statement regarding whether the company’s Codification of Statements on Auditing Standards system of internal control has been effective. Under AU § 325) as a reportable condition in which the 65 Many commenters cited the absence of our final rules, management of a foreign reporting design or operation of one or more of the internal evaluative criteria in AU § 319 in their arguments company who relies on such an evaluation control components does not reduce to a relatively against the reference to AU § 319 in our proposed framework used in its home country is nevertheless low level the risk that misstatements caused by definition of ‘‘internal controls and procedures for under an obligation to state affirmatively whether errors or fraud in amounts that would be material financial reporting.’’ its company’s internal controls are, or are not, in relation to the financial statements being audited 66 See amended Exchange Act Rule 13a–15(c) or effective. may occur and not be detected within a timely 15d–15(c), amended Item 15 of Form 20–F and 69 See AT § 101, paragraph 24. period by employees in the normal course of amended General Instruction (B) to Form 40–F. 70 See Release No. 33–8183 (Jan. 28, 2003) [68 FR performing their assigned functions. See discussion 67 The Guidance on Assessing Control published 6006]. in Section II.B.3.b. below. by the Canadian Institute of Chartered Accountants 71 Management’s acceptance of responsibility for 64 See new Item 308 of Regulations S–B and S– and the Turnbull Report published by the Institute the documentation and testing performed by the K, Item 15 of Form 20–F and General Instruction of Chartered Accountants in England & Wales are auditor does not satisfy the auditor independence B(6) of Form 40–F. examples of other suitable frameworks. rules.

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not amend the Commission’s rules on regarding the extent of evaluation, controls related to the prevention, auditor independence. including the documentation identification, and detection of fraud. required.75 The methods of conducting The nature of a company’s testing c. Material Weaknesses in Internal evaluations of internal control over activities will largely depend on the Control Over Financial Reporting financial reporting will, and should, circumstances of the company and the In the Proposing Release, we did not vary from company to company. significance of the control. However, propose any specific standard on which Therefore, the final rules do not specify inquiry alone generally will not provide management would base its conclusion the method or procedures to be an adequate basis for management’s that the company’s internal control over performed in an evaluation. However, in assessment.78 financial reporting is effective. We conducting such an evaluation and An assessment of the effectiveness of requested comment on whether we developing its assessment of the internal control over financial reporting should prescribe specific standards effectiveness of internal control over must be supported by evidential matter, upon which an effectiveness financial reporting, a company must including documentation, regarding determination would be based, and also maintain evidential matter, including both the design of internal controls and what standards we should consider. documentation, to provide reasonable the testing processes. This evidential Several commenters agreed that the support for management’s assessment of matter should provide reasonable final rules should specify standards, and the effectiveness of the company’s support: for the evaluation of whether all believed that the existence of a internal control over financial reporting. the control is designed to prevent or material weakness in internal control Developing and maintaining such detect material misstatements or over financial eporting should preclude evidential matter is an inherent element omissions; for the conclusion that the a conclusion by management that a of effective internal controls.76 An tests were appropriately planned and registrant’s internal control over instruction to new Item 308 of performed; and that the results of the financial reporting is effective. We have Regulations S–K and S–B and Forms tests were appropriately considered. considered these comments, and agree 20–F and 40–F reminds registrants to The public accounting firm that is that the rules should set forth this maintain such evidential matter.77 required to attest to, and report on, threshold for concluding that a The assessment of a company’s management’s assessment of the company’s internal control over internal control over financial reporting effectiveness of the company’s internal financial reporting is effective. must be based on procedures sufficient control over financial reporting also will The final rules therefore preclude both to evaluate its design and to test its require that the company develop and management from determining that a operating effectiveness. Controls subject maintain such evidential matter to company’s internal control over to such assessment include, but are not support management’s assessment.79 financial reporting is effective if it limited to: controls over initiating, e. Location of Management’s Report identifies one or more material recording, processing and reconciling weaknesses in the company’s internal account balances, classes of transactions Although the final rules do not control over financial reporting.72 For and disclosure and related assertions specify where management’s internal purposes of the final rules, the term included in the financial statements; control report must appear in the ‘‘material weakness’’ has the same controls related to the initiation and company’s annual report, we think it is meaning as in the definition under processing of non-routine and non- important for management’s report to be GAAS and attestation standards.73 The systematic transactions; controls related in close proximity to the corresponding final rules also specify that to the selection and application of attestation report issued by the management’s report must include appropriate accounting policies; and company’s registered public accounting disclosure of any ‘‘material weakness’’ firm. We expect that many companies in the company’s internal control over 75 See, for example, letters re: File No. S7–40–02 will choose to place the internal control financial reporting identified by of: ABA; AICPA; BDO; Intel; and Eli Lilly and report and attestation report near the management in the course of its Company. companies’ MD&A disclosure or in a evaluation.74 76 Section 13(b)(2)(A) of the Exchange Act [15 portion of the document immediately U.S.C. 78m(b)(2)(A)] requires companies to ‘‘make preceding the companies’ financial d. Method of Evaluating and keep books, records, and accounts, which in reasonable detail, accurately and fairly reflect the statements. Many commenters addressed the transactions and dispositions of the assets of the method of evaluating internal control issuer.’’ See also Section 13(b)(2)(B) of the Exchange C. Quarterly Evaluations of Internal Act [15 U.S.C. 78m(b)(2)(B)] and In re Microsoft Control Over Financial Reporting over financial reporting, and some Corp., Administrative Proceeding File No. 3–10789 sought additional precision or guidance (June 3, 2002). In the Microsoft order, the 1. Proposed Rule Commission stated that such books and records We proposed to require a company’s 72 This is consistent with interim attestation include not only general ledgers and accounting standards. See AT § 501. entries, but also memoranda and internal corporate certifying officers to evaluate the 73 The term ‘‘significant deficiency’’ has the same reports. We have previously stated, as a matter of effectiveness of the company’s internal meaning as the term ‘‘reportable condition’’ as used policy, that under Section 13(b)(2) ‘‘every public controls and procedures for financial in AU § 325 and AT § 501. The terms ‘‘material company needs to establish and maintain records reporting as of the end of the period weakness’’ and ‘‘significant deficiency’’ both of sufficient accuracy to meet adequately four represent deficiencies in the design or operation of interrelated objectives: appropriate reflection of covered by each annual and quarterly internal control that could adversely affect a corporate transactions and the disposition of assets; company’s ability to record, process, summarize effective administration of other facets of the 78 This statement should not be interpreted to and report financial data consistent with the issuer’s internal control system; preparation of its mean that management personally must conduct assertions of management in the company’s financial statements in accordance with generally the necessary activities to evaluate the design and financial statements, with a ‘‘material weakness’’ accepted accounting principles; and proper test the operating effectiveness of the company’s constituting a greater deficiency than a ‘‘significant auditing.’’ Statement of Policy Regarding the internal control over financial reporting. Activities, deficiency.’’ Because of this relationship, it is our Foreign Corrupt Practices Act of 1977, Release No. including those necessary to provide management judgment that an aggregation of significant 34–17500 (Jan. 29, 1981) [46 FR 11544]. with the information on which it bases its deficiencies could constitute a material weakness in 77 See Instruction 1 to new Item 308 of assessment, may be conducted by non-management a company’s internal control over financial Regulations S–K and S–B, Instruction 1 to Item 15 personnel acting under the supervision of reporting. of Form 20–F and Instruction 1 to paragraphs (b), management. 74 See new Item 308(d) of Regulations S–B and S– (c), (d) and (e) of General Instruction B.6 to Form 79 See Statements on Standards for Attestation K. 40–F. Engagements No. 10.

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report that the company is required to particularly as the accelerated filing evaluation to suggest that the controls file under the Exchange Act. The deadlines for quarterly reports take are no longer effective.91 company’s certifying officers already are 85 effect. Several other commenters 3. Final Rules required to evaluate the effectiveness of argued that we should not go beyond the company’s disclosure controls and the requirements of Section 404 of the After consideration of the comments procedures on a quarterly basis.80 We Sarbanes-Oxley Act with respect to the received, we have decided not to require noted that a quarterly evaluation frequency of internal control reporting quarterly evaluations of internal control requirement with respect to internal without an adequate basis for doing over financial reporting that are as controls would create symmetry so.86 These commenters remarked that extensive as the annual evaluation. We between our requirements for periodic such a decision would be better made recognize that some controls operate continuously while others operate only evaluations of both the company’s after we have had sufficient experience at certain times, such as the end of the disclosure controls and procedures and with the Section 302 certification fiscal year. We believe that each its internal controls and procedures for requirements adopted in August of company should be afforded the financial reporting, and give effect to the 2002. language in the Section 302 certification flexibility to design its system of requirements regarding quarterly Several commenters suggested internal control over financial reporting internal control evaluations. alternatives to quarterly evaluations. to fit its particular circumstances. The Five commenters stated that it would be management of each company should 2. Comments on the Proposal more appropriate and desirable if perform evaluations of the design and We received responses from 25 companies were required to make operation of the company’s entire commenters on the proposed quarterly disclosure only of material system of internal control over financial amendments. Of the 25 commenters, changes to their internal control that reporting over a period of time that is four supported the proposal to require occurred subsequent to management’s adequate for it to determine whether, as quarterly evaluations of internal most recent annual internal control of the end of the company’s fiscal year, controls and procedures for financial evaluation.87 Two other commenters the design and operation of the reporting.81 One commenter specifically similarly recommended that the company’s internal control over concurred with our objective of creating quarterly evaluation be less rigorous financial reporting are effective. symmetry between the requirements to than the annual evaluation.88 One Accordingly, we are adopting conduct periodic evaluations of both the commenter stated that we should amendments that require a company’s company’s disclosure controls and instead adopt an approach that requires management, with the participation of procedures and its internal controls and less effort and assurance for purposes of the principal executive and financial officers, to evaluate any change in the procedures for financial reporting.82 quarterly reports, such as permitting company’s internal control over Twenty-one commenters opposed companies to test compliance with financial reporting that occurred during quarterly evaluations of internal controls relating to major applications a fiscal quarter that has materially controls.83 Many of these believed that on a rotating basis throughout the affected, or is reasonably likely to quarterly evaluations would impose year.89 This commenter further stated materially affect, the company’s internal substantial additional costs on that the objective of the quarterly control over financial reporting. We also companies without producing any evaluation should be to identify changes have adopted a modification to the incremental benefit to investors. One in controls during the quarter and Section 302 certification requirement individual stated that the proper evaluate whether they would change the and our disclosure requirements to evaluation of a company’s system of certifying officers’ conclusions about adopt this approach, as discussed internal controls is a weighty and time- disclosure controls and internal controls 84 below. consuming process. Twelve of the as stated in the most recent annual The management of a foreign private commenters opposed to quarterly report. The other commenter, although issuer that has Exchange Act reporting evaluations indicated that quarterly opposed to any quarterly evaluation obligations must also, like its domestic evaluations of all aspects of internal requirement, believed that if we did counterparts, report any material controls and procedures would be require it, the quarterly evaluation changes to the issuer’s internal control extremely burdensome, expensive and should be viewed as an update of the over financial reporting. However, difficult to perform under the time annual evaluation, just as the quarterly because foreign private issuers are not constraints of quarterly reporting, report on Form 10–Q is an update of the required to file quarterly reports under annual report on Form 10–K.90 One Section 13(a) or 15(d) of the Exchange 80 See Exchange Act Rules 13a–15(b) and 15d– commenter stated that if we require Act, the final rules clarify that a foreign 15(b) [17 CFR 240.13a–15(b) and 240.15d–15(b)]. some form of quarterly certification, it 81 See letters regarding File No. S7–40–02 of: private issuer’s management need only AICPA; Executive Responsibility; FED; and should be limited to negative assurance disclose in the issuer’s annual report the Protiviti. that nothing has come to the certifying material changes to its internal control 82 See Protiviti letter regarding File No. S7–40–02. officers’ attention since the prior year’s over financial reporting that have 83 See letters regarding File No. S7–40–02 of: occurred in the period covered by the ABA; ACB; ACCA; Association for Financial 85 See letters regarding File No. S7–40–02 of: 92 Professionals (‘‘AFP’’); Am. Bankers Assoc.; BDO; annual report. ABA; ACB; ACCA; BRT; CSC; Emerson; Fried Business Roundtable (‘‘BRT’’); Computer Sciences Frank; ICBA; IPC; NYCB–CCL; SIIA; and SOFTEC. D. Differences Between Internal Control Corporation (‘‘CSC’’); Compass; Thomas Damman 86 (‘‘Damman’’); EEI; Emerson Electric Co. See letters regarding File No. S7–40–02 of: Am. Over Financial Reporting and (‘‘Emerson’’); FEI; Fried, Frank, Harris, Shriver and Bankers Assoc.; CSC; Fried Frank. Disclosure Controls and Procedures Jacobson (‘‘Fried Frank’’); International Paper 87 See letters regarding File No. S7–40–02 of: Company (‘‘IPC’’); ICBA; NYCB–CCL; New York Damman; Compass; EEI; Executive Responsibility Many of the commenters on the State Bar Association (‘‘NYSBA’’); Siemens AG Advisors, LLC (‘‘Executive Responsibility’’); and Proposing Release indicated that they (‘‘Siemens’’); Software & Information Industry Siemens. Association (‘‘SIIA’’); and Software Finance and 88 See letters regarding File No. S7–40–02 of: ABA 91 See Emerson letter regarding File No. S7–40– Tax Executives Council (‘‘SOFTEC’’). and BDO. 02. 84 See Damman letter regarding File No. S7–40– 89 89 See BDO letter regarding File No. S7–40–02. 92 See Exchange Act Rules 13a–15(d) and 15d– 02. 90 See ABA letter regarding File No. S7–40–02. 15(d) [17 CFR 240.13a–15(d) and 240.15d–15(d)].

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were confused as to the differences principles can be viewed as a subset of basis. While the evaluation is of between a company’s disclosure disclosure controls and procedures. effectiveness overall, a company’s controls and procedures and a We agree that some components of management has the ability to make company’s internal control over internal control over financial reporting judgments (and it is responsible for its financial reporting. Exchange Act Rule will be included in disclosure controls judgments) that evaluations, particularly 13a–15(d) defines ‘‘disclosure controls and procedures for all companies. In quarterly evaluations, should focus on and procedures’’ to mean controls and particular, disclosure controls and developments since the most recent procedures of a company that are procedures will include those evaluation, areas of weakness or designed to ensure that information components of internal control over continuing concern or other aspects of required to be disclosed by the company financial reporting that provide disclosure controls and procedures that in the reports that it files or submits reasonable assurances that transactions merit attention. Finally, the nature of under the Exchange Act is recorded, are recorded as necessary to permit the quarterly evaluations of those processed, summarized and reported, preparation of financial statements in components of internal control over within the time periods specified in the accordance with generally accepted financial reporting that are subsumed Commission’s rules and forms. The accounting principles. However, in within disclosure controls and definition further states that disclosure designing their disclosure controls and procedures should be informed by the controls and procedures include, procedures, companies can be expected purposes of disclosure controls and without limitation, controls and to make judgments regarding the procedures.93 procedures designed to ensure that the processes on which they will rely to The rules adopted in August 2002 information required to be disclosed by meet applicable requirements. In doing required the management of an a company in the reports that it files or so, some companies might design their Exchange Act reporting foreign private submits under the Exchange Act is disclosure controls and procedures so issuer to evaluate and disclose accumulated and communicated to the that certain components of internal conclusions regarding the effectiveness company’s management, including its control over financial reporting of the issuer’s disclosure controls and principal executive and principal pertaining to the accurate recording of procedures only in its annual report and financial officers, or persons performing transactions and disposition of assets or not on a quarterly basis. The primary similar functions, as appropriate to to the safeguarding of assets are not reason for this treatment is because allow timely decisions regarding included. For example, a company foreign private issuers are not subject to required disclosure. might have developed internal control mandated quarterly reporting While there is substantial overlap over financial reporting that includes as requirements under the Exchange Act. between a company’s disclosure a component of safeguarding of assets The rules adopted today continue this controls and procedures and its internal dual signature requirements or treatment.94 control over financial reporting, there limitations on signature authority on are both some elements of disclosure checks. That company could F. Periodic Disclosure About the controls and procedures that are not nonetheless determine that this Certifying Officers’ Evaluation of the subsumed by internal control over component is not part of disclosure Company’s Disclosure Controls and financial reporting and some elements controls and procedures. We therefore Procedures and Disclosure About of internal control that are not believe that while there is substantial Changes to its Internal Control Over subsumed by the definition of overlap between internal control over Financial Reporting disclosure controls and procedures. financial reporting and disclosure 1. Existing Disclosure Requirements With respect to the latter point, controls and procedures, many clearly, the broad COSO description of companies will design their disclosure The rules that we adopted in August internal control, which includes the controls and procedures so that they do 2002 to implement the certification efficiency and effectiveness of a not include all components of internal requirements of Section 302 of the company’s operations and the control over financial reporting. Sarbanes-Oxley Act included new Item company’s compliance with laws and 307 of Regulations S-B and S-K. regulations (not restricted to the federal E. Evaluation of Disclosure Controls and Paragraph (a) of Item 307 requires securities laws), would not be wholly Procedures companies, in their quarterly and subsumed within the definition of The rules in place starting in August annual reports, to disclose the disclosure controls and procedures. A 2002 requiring quarterly evaluations of conclusions of the company’s principal number of commenters suggested that disclosure controls and procedures and executive and financial officers (or the narrower concept of internal control, disclosure of the conclusions regarding persons performing similar functions) involving internal control over financial effectiveness of disclosure controls and about the effectiveness of the company’s reporting, is a subset of a company’s procedures have not been substantively disclosure controls and procedures as of disclosure controls and procedures, changed since their adoption, including a date within 90 days of the filing date given that the maintenance of reliable in the rules that we adopt today. These of the quarterly or annual report. This financial reporting is a prerequisite to a evaluation and disclosure requirements disclosure enables the certifying officers company’s ability to submit or file will continue to apply to disclosure to satisfy the representation made in complete disclosure in its Exchange Act controls and procedures, including the reports on a timely basis. This elements of internal control over 93 For example, where a component of internal suggestion focuses on the fact that the financial reporting that are subsumed control over financial reporting is subsumed within elements of internal control over within disclosure controls and disclosure controls and procedures, even where systems testing of that component would clearly be financial reporting requiring a company procedures. required as part of the annual evaluation of internal to have a process designed to provide With respect to evaluations of control over financial reporting, management could reasonable assurance regarding the disclosure controls and procedures, make a different determination of the appropriate reliability of financial reporting and the companies must, under our rules and nature of the evaluation of that component for purposes of a quarterly evaluation of disclosure preparation of financial statements for consistent with the Sarbanes-Oxley Act, controls and procedures. external purposes in accordance with evaluate the effectiveness of those 94 See Exchange Act Rules 13a–15(b) and 15d– generally accepted accounting controls and procedures on a quarterly 15(b).

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their certifications that they have the point at which a company must We are amending the proposal that ‘‘presented in the quarterly or annual undertake an evaluation of its controls would have required companies to report their conclusions about the ‘‘strongly agreed’’ with the proposed disclose any significant changes in its effectiveness of the disclosure controls change to require evaluations as of the internal controls. Under the final rules, and procedures based on their end of the period. Several other a company must disclose any change in evaluation.’’ commenters preferred the existing ‘‘90 its internal control over financial Paragraph (b) of Item 307 requires the days within the filing date’’ evaluation reporting that occurred during the fiscal company to disclose in each quarterly point, noting that it provides more quarter covered by the quarterly report, and annual report whether or not there flexibility than the fixed point. Some of or the last fiscal quarter in the case of were significant changes in the these commenters expressed concern an annual report, that has materially company’s internal controls or in other that it would be hard to conduct affected, or is reasonably likely to factors that could significantly affect evaluations on the last day of the materially affect, the company’s internal these controls subsequent to the date of period. One of the commenters control over financial reporting.98 their evaluation, including any suggested that the proposed requirement Furthermore, we have deleted the corrective actions with regard to that a company disclose changes to its phrase ‘‘or in other factors’’ from significant deficiencies and material internal control over financial reporting Exchange Act Rules 13a–14 and 15d–15 weaknesses. This disclosure enables the that occurred at any time during a fiscal and the form of certification. Although certifying officers to satisfy the quarter was inconsistent with the the final rules do not explicitly require representation made in their proposed requirement that management the company to disclose the reasons for certifications that they have ‘‘indicated evaluate such changes ‘‘as of the end of any change that occurred during a fiscal in the quarterly or annual report each fiscal quarter.’’95 An additional quarter, or to otherwise elaborate about whether or not there were significant commenter asserted that it was critical the change, a company will have to changes in internal controls or in other that we offer companies some guidance determine, on a facts and circumstances factors that could significantly affect as to the types of changes that constitute basis, whether the reasons for the internal controls subsequent to the date ‘‘significant changes.’’96 Finally, a few change, or other information about the of their most recent evaluation, commenters noted that while we had circumstances surrounding the change, including any corrective actions with proposed to delete the words ‘‘or other constitute material information regard to significant deficiencies and factors’’ from Exchange Act Rules 13a– necessary to make the disclosure about material weaknesses.’’ 14(b)(6) and 15d–14(b)(6) regarding the change not misleading.99 While an evaluation of the 2. Proposed Amendments to the disclosure of ‘‘significant changes in effectiveness of disclosure controls and Disclosure Requirements internal controls or in other factors that could significantly affect internal procedures must be undertaken on a In the Proposing Release, we controls, * * *’’ we had not likewise quarterly basis, we expect that for proposed several revisions to the proposed to delete those words from the purposes of disclosure by domestic existing disclosure requirements actual certification language. companies, the traditional relationship regarding: (1) The certifying officers’ between disclosure in annual reports on evaluation of the company’s disclosure 3. Final Disclosure Requirements Form 10–K and intervening quarterly controls and procedures; and (2) After consideration of the comments, reports on Form 10–Q will continue. changes to the company’s internal we are adopting the proposals with Disclosure in an annual report that control over financial reporting. We also several modifications. We are adopting continues to be accurate need not be proposed to require quarterly disclosure as proposed the change of the repeated. Rather, disclosure in quarterly regarding the conclusions of the evaluation date for disclosure controls reports may make appropriate reference certifying officers about the to ‘‘as of the end of the period’’ covered to disclosures in the most recent annual effectiveness of the company’s internal by the quarterly or annual report. We report (and, where appropriate, control over financial reporting. are not specifying the point at which intervening quarterly reports) and Moreover, we proposed to require management must evaluate changes to disclose subsequent developments evaluations of both types of controls as the company’s internal control over required to be disclosed in the quarterly of the end of the period covered by the financial reporting. Given that the final report. quarterly or annual report, rather than rules do not require a company to state We note that, as required by the ‘‘as of a date within 90 days of the filing the conclusions of the certifying officers Sarbanes-Oxley Act, the quarterly date’’ of the quarterly or annual report, regarding the effectiveness of the certification regarding disclosure that as currently required with respect to company’s internal control over the certifying officers must make to the disclosure controls. With respect to the financial reporting as of a particular company’s auditors and audit disclosure about changes to the date on a quarterly basis as proposed, as committee provides:100 company’s internal control over the company must with respect to financial reporting, we proposed to disclosure controls and procedures, it is internal control over financial reporting be as of the require a company to disclose ‘‘any unnecessary to specify a date for the end of the period. significant changes made during the quarterly evaluation of changes in 98 98 We have also made conforming changes to Forms 20–F and 40–F to clarify that the period covered by the quarterly or internal control over financial reporting. management of a foreign private issuer must annual report’’ rather than ‘‘whether or We believe that this change is consistent disclose in the issuer’s annual report filed on Form not there were significant changes in the with the new accelerated reporting 20–F or 40–F any change in the issuer’s internal 97 control over financial reporting that occurred company’s internal control over deadlines. during the period covered by the annual report and financial reporting that could that materially affected, or is reasonably likely to significantly affect these controls 95 95 See ABA letter regarding File No. S7–40–02. affect, this internal control. See Item 15(d) of Form subsequent to the date of their 96 See Intel letter regarding File No. S7–40–02. 20–F and General Instruction B(6)(e) of Form 40– evaluation.’’ 97 See Release No. 33–8128 (Sept. 16, 2002) [67 F. FR 58480]. The final rule amendments do not 99 See Exchange Act Rules 10b–5 and 12b–20 [17 The commenters were mixed in their require that the evaluation take place on the last CFR 240.10b–5 and 17 CFR reaction to these proposed changes. A day of the period, but that the statement of 100 This is the disclosure required by paragraph couple of the commenters remarking on effectiveness of the issuer’s disclosure controls and 5 of the certification form.

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The company’s other certifying officer(s) accounting control provisions of Section Improvement Act of 1991,103 as and I have disclosed, based on our most 13(b)(2) of the Exchange Act 101 and discussed below. Under the Sarbanes- recent evaluation of internal control over current auditing literature.102 If Oxley Act, the PCAOB has become the financial reporting, to the company’s auditors management decides to include a body that sets auditing and attestation and the audit committee of the company’s board of directors (or persons performing the discussion of reasonable assurance in standards generally for registered public equivalent functions): the internal control report, the accounting firms to use in the (a) All significant deficiencies and material discussion must be presented in a preparation and issuance of audit weaknesses in the design or operation of manner that neither makes the reports on the financial statements of internal control over financial reporting disclosure in the report confusing nor issuers, and under Section 404(b) of the which are reasonably likely to adversely renders management’s assessment Sarbanes-Oxley Act, the PCAOB is affect the company’s ability to record, concerning the effectiveness of the required to set standards for the process, summarize and report financial company’s internal control over registered public accounting firms’ information; and financial reporting unclear. attestations to, and reports on, (b) Any fraud, whether or not material, that involves management or other employees G. Attestation to Management’s Internal management’s assessment regarding its who have a significant role in the company’s Control Report by the Company’s internal control over financial reporting. internal control over financial reporting. Registered Public Accounting Firm On April 16, 2003, the PCAOB designated Statements on Standards for We expect that if a certifying officer In the Proposing Release, we Attestation Engagements as existed on becomes aware of a significant proposed to amend Rules 210.1–02 and April 16 as the standard for attestations deficiency, material weakness or fraud 210.2–02 of Regulation S–X to make of management’s assessment of the requiring disclosure outside of the conforming revisions to Regulation S–X effectiveness of internal control over formal evaluation process or after the to reflect the registered public financial reporting pending further management’s most recent evaluation of accounting firm attestation requirements PCAOB standard-setting in the area (and internal control over financial reporting, mandated by Section 404(b) of the subject to our approval of the PCAOB’s he or she will disclose it to the Sarbanes-Oxley Act. Under the actions), and on April 25, we approved company’s auditors and audit proposals, we set forth a definition for the PCAOB’s action. SSAE No. 10 is committee. the new term ‘‘attestation report on thus the standard applicable on a management’s evaluation of internal 4. Conclusions Regarding Effectiveness transition basis for attestations required control over financial reporting’’ and of Disclosure Controls and Procedures under Section 404 of the Act and the certain requirements for the rules we are adopting today, again In disclosures required under current accountant’s attestation report. We are pending further PCAOB standard-setting Item 307 of Regulations S–K and S–B, adopting the proposals substantially as (and our approval). We expect that the Item 15 of Form 20–F and General proposed. However, the final rules PCAOB will assess the appropriateness Instruction B(6) to Form 40–F, some define the expanded term ‘‘attestation of those standards and modify them as companies have indicated that report on management’s evaluation of needed, and any future standards disclosure controls and procedures are internal control over financial adopted by the PCAOB will apply to designed only to provide ‘‘reasonable reporting.’’ Several commenters registered public accounting firms in assurance’’ that the controls and suggested that we use this more specific connection with the preparation and procedures will meet their objectives. In term, noting that auditors currently issuance of attestation reports on reviewing those disclosures, the perform attestation engagements on a management’s assessment of the Commission staff generally has not broad variety of subjects. Amended Rule effectiveness of internal control over objected to that type of disclosure. The 2–02 requires every registered public financial reporting. staff has, however, requested companies accounting firm that issues an audit including that type of disclosure to set report on the company’s financial H. Types of Companies Affected forth, if true, the conclusions of the statements that are included in its Section 404 of the Sarbanes-Oxley Act principal executive and principal annual report required by Section 13(a) states that the Commission must financial officer that the disclosure or 15(d) of the Exchange Act containing prescribe rules that require each annual controls and procedures are, in fact, an assessment by management of the report required by Section 13(a) or 15(d) effective at the ‘‘reasonable assurance’’ effectiveness of the registrant’s internal of the Exchange Act to contain an level. Other companies have included control over financial reporting must internal control report. The Act exempts disclosure that there is ‘‘no assurance’’ attest to, and report on, such that the disclosure controls and registered investment companies from assessment. 104 procedures will operate effectively At the time of the enactment of the this requirement. under all circumstances. In these Sarbanes-Oxley Act, the applicable 1. Foreign Private Issuers instances, the staff has requested standard for attestation by auditors of companies to clarify that the disclosure internal control over financial reporting Section 404 of the Sarbanes-Oxley Act controls and procedures are designed to was set forth in Statements on makes no distinction between domestic provide reasonable assurance of Standards for Attestation Engagements and foreign issuers and, by its terms, achieving their objectives and to set No. 10 (‘‘SSAE No. 10’’). That standard clearly applies to foreign private issuers. forth, if true, the conclusions of the was used by auditors providing These amendments, therefore, apply the principal executive and principal attestations on a voluntary basis to management report on internal control financial officers that the controls and companies, as well as by auditors whose over financial reporting requirement to procedures are, in fact, effective at the financial institution clients are required foreign private issuers that file reports ‘‘reasonable assurance’’ level. to obtain attestations under Federal under Section 13(a) or 15(d) of the The concept of reasonable assurance Deposit Insurance Corporation Exchange Act. We have, however, is built into the definition of internal adopted a later compliance date for control over financial reporting that we 101 101 15 U.S.C. 78m(b)(2). are adopting. This conforms to the 102 See Codification of Statement on Auditing 103 Pub. L. 102–242, 105 Stat. 2242 (1991). standard contained in the internal Standards AU § 319.18. 104 See Section 405 of the Sarbanes-Oxley Act.

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foreign private issuers than for internal control report and the FDIC’s holding companies do so under a accelerated filers. internal control report requirements. provision of Part 363 of the FDIC’s Under regulations adopted by the FDIC regulations111 that permits an insured 2. Asset-Backed Issuers implementing Section 36 of the Federal depository institution that is the In the Proposing Release, we Deposit Insurance Act,106 a federally subsidiary of a holding company to proposed to exclude issuers of asset- insured depository institution with total satisfy its internal control report backed securities from the proposed assets of $500 million or more requirements with an internal control rules implementing Section 404 of the (‘‘institution’’), is required, among other report of the consolidated holding Act. We noted that because of the things, to prepare an annual company’s management if: unique nature of asset-backed issuers, management report that contains: • Services and functions comparable such issuers are subject to substantially • A statement of management’s to those required of the subsidiary by different reporting requirements. Most responsibility for preparing the Part 363 are provided at the holding significantly, asset-backed issuers are institution’s annual financial company level;112 and generally not required to file the types statements, for establishing and • The subsidiary has, as of the of financial statements that other maintaining an adequate internal beginning of its fiscal year, (i) total companies must file. Also, such entities control structure and procedures for assets of less than $5 billion or (ii) total typically are passive pools of assets, financial reporting, and for complying assets of $5 billion or more and a without a board of directors or persons with designated laws and regulations composite rating of 1 or 2 under the acting in a similar capacity. We did not relating to safety and soundness;107 and Uniform Financial Institutions Rating receive any comments on the proposed • Management’s assessment of the System.113 exclusion of asset-backed issuers from effectiveness of the institution’s internal Section 404 of the Sarbanes-Oxley Act the internal control reporting control structure and procedures for does not contain an exemption for requirements, and we are excluding financial reporting as of the end of the insured depository institutions that are asset-backed issuers from the new fiscal year and the institution’s both subject to the FDIC’s internal disclosure requirements as proposed. compliance with the designated safety control report requirements and and soundness laws and regulations required to file Exchange Act reports. In 3. Small Business Issuers during the fiscal year.108 fact, it makes no distinction whatsoever Our proposed rules implementing The FDIC’s regulations additionally between institutions subject to the Section 404 of the Act did not require the institution’s independent FDIC’s requirements and other types of distinguish between large and small accountant to examine, and attest to, Exchange Act filers. Accordingly, issuers. Similarly, Section 404 of the management’s assertions concerning the regardless of whether an insured Act directs that the management report effectiveness of the institution’s internal depository institution is subject to the on internal control over financial control structure and procedures for FDIC’s requirements, insured depository reporting apply to any company filing financial reporting.109 The institution’s institutions or holding companies that periodic reports under Section 13(a) or management report and the accountant’s are required to file periodic reports 15(d) of the Exchange Act. Accordingly, attestation report must be filed with the under Section 13(a) or 15(d) of the these amendments apply to all issuers FDIC, the institution’s primary federal Exchange Act are subject to the internal that file Exchange Act periodic reports, regulator (if other than the FDIC), and control reporting requirements that we except registered investment companies, any appropriate state depository are adopting today. regardless of their size. However, we are institution supervisor and must be Although our final rules are similar to sensitive that many small business available for public inspection.110 the FDIC’s internal control report issuers may experience difficulty in Although bank and thrift holding requirements, the rules differ in a few evaluating their internal control over companies are not required under the significant respects. Most notably, our financial reporting because these issuers FDIC’s regulations to prepare these final rules do not require a statement of may not have as formal or well- internal control reports, many of these compliance with designated laws and structured a system of internal control regulations relating to safety and over financial reporting as larger 106 12 U.S.C. 1831m. soundness. Conversely, the following companies. Accordingly, we are 107 The designated laws and regulations are providing an extended compliance federal laws and regulations concerning loans to 111 12 CFR Part 363. insiders and federal and state laws and regulations 112 period for small business issuers and Services and functions are considered concerning dividend restrictions. See 12 CFR part ‘‘comparable’’ if the holding company prepares and other companies that are not accelerated 363, Appendix A, Guideline 12. submits the management assessment of the filers.105 In addition, our approach of 108 See 12 CFR 363.2, adopted in 58 FR 31332. effectiveness of the internal control structure and not mandating specific criteria to be These requirements only apply to an insured procedures for financial reporting and compliance depository institution with total assets of $500 with the designated safety and soundness laws and used by management to evaluate a million or more. We recognize that the FDIC’s regulations based on information concerning the company’s internal control over regulations use the term ‘‘internal control structure relevant activities and operations of those financial reporting should provide small and procedures for financial reporting’’ rather than subsidiary institutions subject to Part 363. See 12 issuers some flexibility in meeting these the term ‘‘internal control over financial reporting’’ CFR Part 363, Appendix A, Guideline 4. used in our rules. We think the differences in the 113 disclosure requirements. This rating is more commonly known as the meaning of the two terms are insignificant because CAMELS rating, which addresses Capital adequacy, 4. Bank and Thrift Holding Companies both Section 36(b)(2) of the Federal Deposit Asset quality, Management, Earnings, Liquidity and Insurance Act and Section 404(a) of the Sarbanes- Sensitivity to market risk. See 12 CFR 363.1(b)(2). In the Proposing Release, we stated Oxley Act refer to ‘‘internal control structure and The appropriate federal banking agency may that we were coordinating with the procedures for financial reporting.’’ Nevertheless, determine that an insured depository institution the FDIC has defined the term ‘‘financial reporting’’ with total assets in excess of $9 billion that is a Federal Deposit Insurance Corporation to include financial statements prepared in subsidiary of a holding company may not satisfy its (the ‘‘FDIC’’) and the other federal accordance with generally accepted accounting FDIC internal control report requirement with an banking regulators to eliminate, to the principles (‘‘GAAP’’) and those prepared for internal control report of the consolidated holding extent possible, any unnecessary regulatory reporting purposes (see FDIC Financial company’s management if the agency determines Institution Letter FIL–86–94, dated December 23, that there could be a significant risk to the affected duplication between our proposed 1994). deposit insurance fund if the institution were 109 12 CFR 363.3. allowed to satisfy its requirements in this manner. 105 See Section II. J. below. 110 12 CFR 363.4(a) and (b). See 12 CFR 363.1(b)(3).

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provisions in our rules are not included exemption in our rules mirroring the regulations relating to safety and in the FDIC’s regulations: FDIC’s exemption that excludes insured soundness designated by the FDIC and • The requirement that the report depository institutions or their holding the appropriate federal banking include a statement identifying the companies with less than $500 million agencies; framework used by management to in assets from the internal control report • A statement identifying the evaluate the effectiveness of the requirements. framework used by management to company’s internal control over After consultation with the staffs of evaluate the effectiveness of the financial reporting;114 the FDIC, the Federal Reserve Board, the registrant’s internal control over • The requirement that management Office of Thrift Supervision and the financial reporting as required by disclose any material weakness that it Office of the Comptroller of Currency, Exchange Act Rule 13a–15 or 15d–15; has identified in the company’s internal we have determined that insured • Management’s assessment of the control over financial reporting (and depository institutions that are subject effectiveness of the registrant’s internal related stipulation that management is to Part 363 of the FDIC’s regulations (as control over financial reporting as of the not permitted to conclude that the well as holding companies permitted to end of the registrant’s most recent fiscal company’s internal control over file an internal control report on behalf year, including a statement as to financial reporting is effective if there of their insured depository institution whether or not management has are one or more material weaknesses); subsidiaries in satisfaction of these concluded that the registrant’s internal • The requirement that the company regulations) and also subject to our new control over financial reporting is state that the registered public rules implementing Section 404 of the effective, and of the institution’s accounting firm that audited the Sarbanes-Oxley Act 116 should be compliance with the designated safety financial statements included in the afforded considerable flexibility in and soundness laws and regulations annual report has issued an attestation determining how best to satisfy both during the fiscal year. This discussion report on management’s assessment of sets of requirements. Therefore, they can must include disclosure of any material the company’s internal control over choose either of the following two weakness in the registrant’s internal financial reporting; and options: control over financial reporting • The requirement that the company • They can prepare two separate identified by management; 118 and • must provide the registered public management reports to satisfy the A statement that the registered accounting firm’s attestation report on FDIC’s and our new requirements; or public accounting firm that audited the management’s assessment of internal • They can prepare a single financial statements included in the control over financial reporting in the management report that satisfies both registrant’s annual report has issued an company’s annual report filed under the the FDIC’s requirements and our new attestation report on management’s Exchange Act.115 requirements. assessment of the registrant’s internal Several commenters generally If an insured depository institution or control over financial reporting. supported our goal to eliminate or its holding company chooses to prepare Additionally, the institution or holding reduce duplicative reporting a single report to satisfy both sets of company will have to provide the requirements. Some of these requirements, the report of management registered public accounting firm’s commenters asserted that we should on the institution’s or holding attestation report on management’s recognize the substantial protections to company’s internal control over assessment in its annual report filed depositors and investors provided by financial reporting (as defined in under the Exchange Act.119 For the federal laws that govern depository Exchange Act Rule 13a–15(f) or 15d– purposes of the report of management institutions and their holding 15(f)) will have to contain the and the attestation report, financial companies. They suggested that our following: 117 reporting must encompass both final rules should state that compliance • A statement of management’s financial statements prepared in with the FDIC’s internal control report responsibility for preparing the accordance with GAAP and those requirements satisfies the internal registrant’s annual financial statements, prepared for regulatory reporting control report requirements that we are for establishing and maintaining purposes. adequate internal control over financial adopting under Section 404. A number I. Registered Investment Companies of these commenters also thought that if reporting for the registrant, and for the we did not exempt insured depository institution’s compliance with laws and Section 404 of the Sarbanes-Oxley Act institutions already filing internal does not apply to registered investment control reports under the FDIC’s 116 Our rules do not provide an exemption that parallels the FDIC’s exemption for insured 118 Management will not be permitted to conclude requirements, we should provide an depository institutions with less than $500 million that the registrant’s internal control over financial in assets. It would be incongruous to provide an reporting is effective if there are one or more 114 The FDIC’s regulations do not specifically exemption in our rules for small depository material weaknesses in the registrant’s internal require that management identify the control institutions and not other small, non-depository control over financial reporting. framework used to evaluate the effectiveness of the Exchange Act reporting companies. 119 An insured depository institution subject to institution’s internal control over financial 117 An insured depository institution subject to both the FDIC’s requirements and our new reporting. However, given the requirements of both the FDIC’s requirements and our new requirements choosing to file a single management Sections 101 and 501 of the American Institute of requirements choosing to file a single report to report to satisfy both sets of requirements will file Certified Public Accountants’ attestation standards, satisfy both sets of requirements will file the report the attestation report with its primary federal the FDIC believes that the framework used must be with its primary federal regulator under the regulator under the Exchange Act and the FDIC, its disclosed or otherwise publicly available to all Exchange Act and the FDIC, its primary federal primary federal regulator (if other than the FDIC), users of reports that institutions file with the FDIC regulator (if other than the FDIC), and any and any appropriate state depository institution pursuant to Part 363 of the FDIC’s regulations. appropriate state depository institution supervisor supervisor under Part 363 of the FDIC’s regulations. 115 The FDIC’s regulations do require an under Part 363 of the FDIC’s regulations. A holding A holding company choosing to prepare a single independent public accountant to examine, attest company choosing to prepare a single report to management report to satisfy both sets of to, and report separately on, the assertion of satisfy both sets of requirements will file the report requirements will file the attestation report with the management concerning the institution’s internal with the Commission under the Exchange Act and Commission under the Exchange Act and the FDIC, control structure and procedures for financial the FDIC, the primary federal regulator of the the primary federal regulator of the insured reporting, but these regulations do not require the insured depository institution subsidiary subject to depository institution subsidiary subject to the accountant to be a registered public accounting the FDIC’s requirements, and any appropriate state FDIC’s requirements, and any appropriate state firm. See 12 CFR 363.3(b). depository institution supervisor under Part 363. depository institution supervisor under Part 363.

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companies, and we are not extending Sarbanes-Oxley Act for registered record, process, summarize, and report any of the requirements that would investment companies in order to financial information. implement section 404 to registered conform to the changes that we are We are not, however, adopting investment companies.120 Several adopting for operating companies.124 proposed amendments that would have commenters objected to the proposed • Paragraph (d) of Investment required the evaluation by an requirement that the Section 302 Company Act Rule 30a–3. The investment company’s management of certification include a statement of the amendments use the same term the effectiveness of its disclosure officers’ responsibility for internal ‘‘internal control over financial controls and procedures to be as of the controls.121 These commenters argued reporting’’ that we are using in the rules end of the period covered by each report that this requirement would contradict for operating companies and include the on Form N–CSR, rather than within 90 Section 405 of the Sarbanes-Oxley Act same definition of ‘‘internal control over days prior to the filing date of the and represent a ‘‘back-door’’ application financial reporting’’ that we are report, as our certification rules of Section 404, from which registered adopting in Exchange Act Rules 13a– currently require.125 Commenters noted investment companies are exempt.122 15(f) and 15d–15(f). that this would require investment We disagree. The certification • Paragraph (a) of Investment company complexes that have funds requirements implement Section 302 of Company Act Rule 30a–3. The with staggered fiscal year ends to the Sarbanes-Oxley Act, from which amendments require every registered perform evaluations of their disclosure registered investment companies are not management investment company, other controls and procedures as many as exempt.123 We are not subjecting than a small business investment twelve times per year. They argued that registered investment companies to the company, to maintain internal control requiring such frequent evaluations requirements implementing Section 404 over financial reporting. These would be extremely costly, inefficient, of the Sarbanes-Oxley Act, including the amendments parallel those that we are and operationally disruptive, and would annual and quarterly evaluation adopting for operating companies in not provide any benefits to requirements with respect to internal Exchange Act Rules 13a–15(a) and 15d– shareholders.126 We agree that the costs control over financial reporting and the 15(a). of requiring investment company requirements for an annual report by • Introductory text and sub– complexes to perform evaluations of management on internal control over paragraph (b) of paragraph 4 of the their disclosure controls and procedures financial reporting and an attestation certification in Item 10(a)(2) of Form N– twelve times per year would outweigh report on management’s assessment. CSR. The amendments require the the benefits to investors. The We are adopting the following signing officers to state that they are certification rules we are adopting will technical changes to our rules and forms responsible for establishing and require an investment company implementing Section 302 of the maintaining internal control over complex to perform at most four such financial reporting, and that they have evaluations per year.127 120 See Section 405 of the Sarbanes-Oxley Act designed such internal control over (‘‘Nothing in section 401, 402, or 404, the Transition Period for Registered amendments made by those sections, or the rules financial reporting, or caused such Investment Companies of the Commission under those sections shall apply internal control over financial reporting to any investment company registered under to be designed under their supervision, Registered investment companies section 8 of the Investment Company Act of 1940 to provide reasonable assurance must comply with the rule and form (15 U.S.C. 80a–8).’’). The provisions that would not amendments applicable to them on and extend to registered investment companies include regarding the reliability of financial reporting and the preparation of after August 14, 2003, except as follows. amendments to Exchange Act rules 13a–15(c) and Registered investment companies must 15d–15(c) (requiring annual evaluation of the financial statements for external effectiveness of internal control over financial purposes in accordance with generally comply with the amendments to reporting); Exchange Act rules 13a–15(d) and 15d– Exchange Act Rules 13a–15(a) and 15d– 15(d) (requiring quarterly evaluation of any change accepted accounting principles. • Paragraph (4)(d) of the certification 15(a) and Investment Company Act Rule in internal control over financial reporting that has 30a–3(a) that require them to maintain materially affected, or is reasonably likely to of Item 10(a)(2), and Item 9(b) of Form materially affect, internal control over financial N–CSR. The amendments require internal control over financial reporting reporting); and Items 308(a) and (b) of Regulations with respect to fiscal years ending on or S–K and S–B (requiring annual report by disclosure of any change in the investment company’s internal control after June 15, 2004. In addition, management on internal control over financial registered investment companies must reporting and attestation report on management’s over financial reporting that occurred evaluation of internal control over financial during the most recent fiscal half-year comply with the portion of the reporting). introductory language in paragraph 4 of that has materially affected, or is 121 Proposed paragraph 4 of the certification the certification in Item 10(a)(2) of Form reasonably likely to materially affect, section of proposed Form N–CSR. Proposing N–CSR that refers to the certifying the company’s internal control over Release, note 26 above, 67 FR at 66250. We received officers’ responsibility for establishing 7 comment letters on the proposed changes to the financial reporting. certification rules with respect to investment • Paragraph (5) of the certification of companies in the Proposing Release. See letters 125 Proposed Exchange Act Rules 13a–15(c) and regarding File No. S7–40–02 of: the Investment Item 10(a)(2) of Form N–CSR. The 15d–15(c), proposed Investment Company Act Rule Company Institute (‘‘ICI’’); Protiviti; amendments require the signing officers 30a–2(b)(4)(iii), and proposed Investment Company OppenheimerFunds, Inc. (‘‘Oppenheimer’’); The to state that they have disclosed to the Act Rule 30a–3(b). Association of the Bar of the City of New York; investment company’s auditors and the 126 See letters regarding File No. S7–40–02 of: Leslie Ogg of Board Services Corporation (‘‘Ogg’’); audit committee all significant D&T; ICI; Ogg; and Oppenheimer. Federated Funds; and D&T. 127 See Release No. IC–25914 (Jan. 27, 2003) [68 122 See letters regarding File No. S7–40–02 of: deficiencies and material weaknesses in FR 5348, 5352 n. 43] (noting that in the case of a Association of the Bar of the City of New York; ICI; the design or operation of internal series fund or family of investment companies in and Oppenheimer. control over financial reporting which which the disclosure controls and procedures for 123 See Section 302(a)(4)(A) and (B) of the are reasonably likely to adversely affect each fund in the series or family are the same, a Sarbanes-Oxley Act (requiring signing officers to single evaluation of the effectiveness of the certify that they are responsible for establishing and the investment company’s ability to disclosure controls and procedures for the series or maintaining internal controls and have designed the family could be used in multiple certifications for internal controls to ensure that material information 124 For a discussion of changes to the form of the the funds in the series or family, as long as the relating to the issuer is made known to the signing Section 302 certification for operating companies, evaluation has been performed within 90 days of officers). see Section III.D. below. the report on Form N–CSR).

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and maintaining internal control over addition, the transition period will Forms 20–F and 40–F and Item 601 of financial reporting, as well as paragraph provide additional time for the PCAOB Regulations S–B and S–K to add the 4(b) of the certification, beginning with to consider relevant factors in Section 302 certifications to the list of the first annual report filed on Form N– determining and implementing any new required exhibits. In addition, we CSR for a fiscal year ending on or after attestation standard as it finds proposed to amend Exchange Act Rules June 15, 2004. appropriate, subject to our approval. 13a–14 and 15d–14 to require that Consistent with this extended J. Transition Period Section 906 certifications accompany compliance period for management’s the periodic reports to which they We received a number of comments internal control report and the related relate, and to amend Forms 20–F and urging us to adopt an extended attestation, and for the subsequent 40–F and Item 601 of Regulations S–B transition period for compliance with evaluation of changes in internal control the new disclosure requirements.128 We and S–K to add Section 906 over financial reporting, the following certifications to the list of required have decided to delay the compliance provisions of the rules adopted today date of the requirement to provide a exhibits. We also proposed to amend are subject to the extended compliance Investment Company Act Rule 30a–2 to management report assessing the period: require that Section 906 certifications effectiveness of internal control over • The provisions of Items 308(a) and financial reporting and an auditor’s (b) of Regulations S–K and S–B and the accompany the periodic reports on attestation to, and report on, that comparable provisions of Forms 20–F Form N–CSR to which they relate and assessment beyond that in the Proposing and 40–F requiring management’s Item 10 of Form N–CSR to add the Release so that companies and their internal control report and the related Section 906 certifications as a required auditors will have time to prepare and attestation; exhibit. satisfy the new requirements. These • The amendments to Rules 13a–15(a) We received eight comment letters in compliance dates do not apply to and 15d–15(a) under the Exchange Act response to the proposals.131 The registered investment companies, which relating to maintenance of internal primary topic addressed by the are not required to provide the control over financial reporting; and commenters was whether Section 906 of • management report assessing the The provisions of Rules 13a–15(c) the Sarbanes-Oxley Act applied to effectiveness of internal control over and (d) and 15d–15(c) and (d) under the annual reports filed on Form 11–K. financial reporting and the related Exchange Act requiring evaluations of Most of the commenters believed that auditor’s attestation.129 A company that internal control over financial reporting is an ‘‘accelerated filer,’’ as defined in issuers required to file annual reports on and changes thereto. Form 11–K should be exempt from the Exchange Act Rule 12b–2, as of the end The extended compliance period does of its first fiscal year ending on or after requirement to furnish a Section 906 not in any way affect the provisions of certification as an exhibit.132 Two June 15, 2004, must begin to comply our other rules and regulations with the management report on internal commenters noted that the language of regarding internal controls that are in Section 906 that requires certification of control over financial reporting effect, including, without limitation, disclosure requirements promulgated the chief executive officer and chief Rule 13b–2 under the Exchange Act. financial officer (or equivalent thereof) under Section 404 of the Sarbanes- Other rules relating to evaluation and is inconsistent with the actual Oxley Act in its annual report for that disclosure adopted today are effective administration of employee benefit fiscal year. We recognize that non- on August 14, 2003. These other rules plans because such plans do not have accelerated filers, including smaller include amendments to Items 308(c) of individuals acting as chief executive companies and foreign private issuers, Regulations S–K and S–B and the officer and chief financial officer.133 may have greater difficulty in preparing comparable provisions of Forms 20–F the management report on internal and 40–F requiring disclosure regarding Those commenters noted that employee control over financial reporting. certain changes in internal control over benefit plans are typically administered Therefore, these types of companies financial reporting. These amendments through one or more committees that are must begin to comply with the modify existing requirements regarding appointed as the plan’s named disclosure requirements in annual disclosure of changes in internal control fiduciaries to administer the plan and 134 reports for their first fiscal year ending over financial reporting, are related to oversee investments. In addition, on or after April 15, 2005. A company statements made in the Section 302 some commenters believed that we must begin to comply with the quarterly certifications of principal executive and should provide an exemption for Form evaluation of changes to internal control financial officers, and provide 11–K because employee benefit plans over financial reporting requirements clarifications that are beneficial and are already subject to extensive for its first periodic report due after the whose implementation need not be regulation under the Employee first annual report that must include delayed. These other rules that are Retirement Income Security Act of 1974 management’s report on internal control effective on August 14, 2003 also (‘‘ERISA’’),135 which includes a over financial reporting. We believe that include amendments relating to requirement for the plan administrator the transition period is appropriate in disclosure controls and procedures. to certify, under penalties of perjury and light of both the substantial time and other criminal and administrative resources needed to properly implement III. Discussion of Amendments Related 130 to Certifications the rules and the corresponding 131 See letters regarding File No. S7–06–03 of: benefit to investors that will result. In A. Proposed Rules ABA; Cleary, Gottlieb, Steen & Hamilton (‘‘Cleary’’); Prof. Paul A. Griffin (‘‘Griffin’’); Intel Corporation 128 See, for example, the letters regarding File No. We proposed to amend our rules and (‘‘Intel’’); ICI; PwC; John Stalnaker and Patrick S7–40–02 of: AICPA; D&T; CSC; E&Y; and forms to require companies to file the Derksen (‘‘Stalnaker’’); and Rooks Pitts (‘‘Rooks’’). Association of the Bar of the City of New York, certifications required by Section 302 of 132 See letters regarding File No. S7–06–03 of: Committee on Securities Regulation (‘‘NYCB– ABA; Cleary; Intel; and PwC. CSR’’). the Sarbanes-Oxley Act as an exhibit to 133 See letters File No. S7–06–03 of ABA and 129 See Section II. I., above, for compliance dates the periodic reports to which they Cleary. applicable to registered investment companies. relate. Specifically, we proposed to 134 Id. 130 See Section V. below. amend the exhibit requirements of 135 Pub. L. No. 83–406, 88 Stat. 129 (1974).

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penalties, the accuracy of the plan’s 6–K and 8–K and annual reports on failure to furnish the Section 906 disclosures under ERISA.136 Form 11–K and the possibility of taking certifications would cause the periodic Commenters also addressed other additional action. report to which they relate to be topics related to Section 906. One incomplete, thereby violating Section B. Final Rules commenter requested that the 13(a) of the Exchange Act.148 In Commission allow Section 906 We are amending the exhibit addition, referencing the Section 906 certifications to remain confidential.137 requirements of Forms 20–F and 40–F certifications in Exchange Act Rules That commenter expressed concern that and Item 601 of Regulations S–B and S– 13a–14 and 15d–14 and Investment a plaintiff could use a Section 906 K to add the Section 302 certifications Company Act Rule 30a–2 subjects these certification to create a basis for liability to the list of required exhibits.145 In the certifications to the signature that did not otherwise exist.138 One final rules, the specific form and content requirements of Rule 302 of Regulation commenter objected to the proposal to of the required certifications is set forth S–T.149 deem Section 906 certifications as in the applicable exhibit filing Section 906 requires that the ‘‘furnished,’’ rather than as ‘‘filed.’’139 requirement.146 To coordinate the rules certifications ‘‘accompany’’ the periodic After considering all of the comments, requiring an evaluation of ‘‘disclosure report to which they relate. This is in we are adopting the proposals controls and procedures’’ and ‘‘internal contrast to Section 302, which requires substantially as proposed. control over financial reporting,’’ we are the certifications to be included ‘‘in’’ the On April 11, 2003, U.S. Senator moving the definition of the term periodic report. In recognition of this Joseph Biden introduced a statement ‘‘disclosure controls and procedures’’ difference, we are permitting companies into the Congressional Record that from Exchange Act Rules 13a–14(c) and to ‘‘furnish,’’ rather than ‘‘file,’’ the discusses Section 906.140 The statement 15d–14(c) and Investment Company Act Section 906 certifications with the asserts that Section 906 ‘‘is intended to Rule 30a–2(c) to new Exchange Act Commission.150 Thus, the certifications apply to any financial statement filed by Rules 13a–15(c) and 15d–15(c) and would not be subject to liability under a publicly-traded company, upon which Investment Company Act Rule 30a–3(c), Section 18 of the Exchange Act.151 the investing public will rely to gauge respectively. Moreover, the certifications would not the financial health of the company,’’ We are amending Exchange Act Rules be subject to automatic incorporation by which includes financial statements 13a–14 and 15d–14 and Investment reference into a company’s Securities included in current reports on Forms 6– Company Act Rule 30a–2 to require the Act registration statements, which are K and 8–K and annual reports on Form Section 906 certifications to accompany subject to liability under Section 11 of 11–K.141 The language added to Title 18 periodic reports containing financial the Securities Act,152 unless the issuer by Section 906 refers to ‘‘periodic statements as exhibits. We also are takes steps to include the certifications reports containing financial amending the exhibit requirements in in a registration statement. statements,’’ and our proposals to Forms 20–F, 40–F and Item 601 of Although Section 906 does not require companies to furnish Section Regulations S–B and S–K to add the explicitly require the certifications to be 906 certifications as exhibits applied to Section 906 certifications to the list of made public, we believe that it is periodic (annual, semi-annual and required exhibits to be included in appropriate to require certifications that quarterly) reports but did not address reports filed with the Commission. In ‘‘accompany’’ a publicly filed periodic current reports on Forms 6–K and 8– addition, we are amending Item 10 of report to be provided publicly in this K.142 One commenter addressed the Form N–CSR to add the Section 906 manner. We believe that Congress statement in the Congressional Record, certifications as a required exhibit. intended for Section 906 certifications indicating that the suggested Because the Section 906 certification requirements would create substantial requirement applies to periodic reports 15(d) of the Exchange Act); n. 28 above (discussing practical burdens for companies to containing financial statements that are issuers covered by Sections 13(a) and 15(d) of the filed by an issuer pursuant to Section Exchange Act). Registered management investment provide Section 906 certifications in companies that are required to file reports on Form current reports filed on Forms 6–K or 8– 13(a) or 15(d) of the Exchange Act, the N–CSR pursuant to Section 13(a) or 15(d) of the K.143 We are also concerned that exhibit requirement will only apply to Exchange Act will be required to provide the extending Section 906 certifications to reports on Form N–CSR filed under Section 906 certifications under Exchange Act these sections and not to reports on Rules 13a–14(b) and 15d–14(b) as well as Forms 6–K or 8–K could potentially Investment Company Act Rule 30a–2(b). By chill the disclosure of information by Form N–CSR that are filed under the contrast, registered management investment companies. As noted above, four Investment Company Act only.147 A companies that are required to file reports on Form commenters argued that Section 906 N–CSR are required to provide the Section 302 144 145 We recently adopted Form N–CSR, to be used certifications solely under Investment Company Act should not apply to Form 11–K. In Rule 30a–2(a), which was adopted under Sections light of these developments, we are by registered management investment companies to file certified shareholder reports with the 13(a) and 15(d) of the Exchange Act as well as the considering, in consultation with the Commission. See Release No. IC–25914 (Jan. 27, Investment Company Act. Release No. 33–8124 Department of Justice, the application of 2003) [68 FR 5348]. As adopted, Form N–CSR (Aug. 28, 2002) [67 FR 57276, 57295]; Release No. Section 906 to current reports on Forms requires the Section 302 certifications to be filed as IC–25914 (Jan. 27, 2003) [68 FR 5348, 5365]. an exhibit to a report on Form N–CSR. Item 10(b) 148 See also Section 3(b)(1) of the Sarbanes-Oxley Act, which provides that ‘‘[a] violation by any 136 of Form N–CSR. See letters regarding File No. S7–06–03 of: 146 person of this Act * * * shall be treated for all ABA; Cleary; and PwC. Accordingly, we are revising Exchange Act Rules 13a–14 and 15d–14 to delete from those rules purposes in the same manner as a violation of the 137 See ABA letter regarding File No. S7–06–03. the detailed description of the contents of the Securities Exchange Act of 1934 * * * and any 138 Id. required certifications and to revise the instructions such person shall be subject to the same penalties, 139 See Stalnaker letter regarding File No. S7–06– to Forms 10–Q, 10–QSB, 10–K, and 10–KSB to and to the same extent, as for a violation of that 03. delete the references to the Section 302 certification Act* * *.’’ 140 See 149 Cong. Rec. S5325 (daily ed. Apr. 11, requirements. We are also adopting similar changes 149 See Rule 302(b) of Regulation S–T [17 CFR 2003). to Investment Company Act Rule 30a–2 and Form 232.302(b)]. Among other things, this rule requires 141 Id. at S5331. N–CSR. that an issuer maintain manually signed 142 See Release No. 33–8212 (Mar. 21, 2003) [68 147 See General Instruction A of Form N–CSR certifications or other authenticating documents. FR 15600] at fn. 37. (Form N–CSR is a combined reporting form to be 150 See, for example, Item 601(b)(32)(ii) of 143 See ABA letter regarding File No. S7–06–03. used for reports of registered management Regulation S–K. 144 See letters regarding File No. S7–06–03 of: investment companies under Section 30(b)(2) of the 151 15 U.S.C. 78r. ABA; Cleary; Intel; and PwC. Investment Company Act and Sections 13(a) or 152 15 U.S.C. 77k.

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to be publicly provided. Civil liability investment companies, that interim • We have clarified that the statement already exists under our signature voluntary guidance shall remain in as effectiveness of disclosure controls requirements and the Section 302 effect until the rules become effective. and procedures be as of the end of the certifications. In addition, any Section In the event that the EDGAR system is period, but that the date of the 906 certification submitted to the not updated by the effective date, evaluation is not specified; and Commission as correspondence is companies should submit the required • We have made minor changes in the subject to the Freedom of Information certifications as Exhibit 99.158 For organization of the certification. Act.153 Finally, the requirement to registered investment companies, the E. Transition Period furnish Section 906 certifications as interim guidance shall remain in effect exhibits serves a number of important until the rules become effective.159 The final rules regarding filing of certifications under Sections 302 and functions. First, the exhibit requirement D. Form of Section 302 Certifications enhances compliance by allowing the 906, for companies other than registered Commission, the Department of Justice We proposed several amendments to investment companies, will be effective and the public to monitor the the form of certifications to be provided on August 14, 2003. The compliance certifications effectively. Second, by pursuant to Section 302 of the Sarbanes- dates applicable to registered subjecting the Section 906 certifications Oxley Act. In particular, we proposed investment companies are described in the following: Section II. I., above. to the signature requirements of • Regulation S–T, companies are required The addition of a statement that We believe that changes in the form to retain a manually signed signature principal executive and financial of Section 302 certification described page or other authenticating document officers are responsible for designing above are beneficial to both registrants for a five-year period. This requirement internal controls and procedures for and investors because they clarify the helps to preserve evidential matter in financial reporting or having such provisions of the certification. With one the event of prosecution. controls and procedures designed under exception, discussed below, the changes their supervision; There are important distinctions to be • are also not related to our new made between Sections 302 and 906 of The clarification that disclosure requirements regarding management’s the Sarbanes-Oxley Act. Unlike the controls and procedures may be internal control report. With that one Section 302 certifications, the Section designed under the supervision of exception, appropriateness of the 906 certifications are required only in principal executive and financial modified certification is thus not officers; and periodic reports that contain financial • affected by the extended compliance statements. Therefore, amendments to The revision of the statement as to period we are providing in connection periodic reports that do not contain the effectiveness of disclosure controls with management’s internal control financial statements would not require a and procedures and internal controls report and the related attestation. Our new Section 906 certification, but and procedures for financial reporting rules adopted today also therefore would require a new Section 302 would be as of the end of the period. provide that the form of Section 302 We have adopted the proposals certification to be filed with the certification will be modified, with that referred to above substantially as amendment.154 In addition, unlike the one exception, in accordance with these proposed. In addition, we have made Section 302 certifications, the Section rules effective on August 14, 2003. the following changes: 906 certifications may take the form of • We have incorporated the term We are applying the extended a single statement signed by a ‘‘internal control over financial compliance period to the portion of the company’s chief executive and financial introductory language in paragraph 4 of 155 reporting’’ into the certification; officers. • We have amended the provision of the Section 302 certification that refers to the certifying officers’ responsibility C. Effect on Interim Guidance Regarding the certification relating to changes in for establishing and maintaining Filing Procedures internal control over financial reporting, consistent with the final rules discussed internal control over financial reporting We provided interim guidance above regarding evaluation and for the company, as well as paragraph regarding voluntary filing procedures disclosure, so that it refers to changes 4(b), which must be provided in the first for Section 906 certifications.156 That that have materially affected or are annual report required to contain guidance encouraged issuers to submit reasonably likely to materially affect management’s internal control report their Section 906 certifications as internal control over financial reporting; and thereafter. As noted above, this exhibits to the periodic reports to which extended compliance period does not in they relate.157 For issuers that are not insert the following legend after the text of each any way affect the provisions of our certification: ‘‘A signed original of this written other rules and regulations regarding 153 5 U.S.C. 552 et seq. statement required by Section 906, or other internal controls that are in effect. 154 See Exchange Act Rule 12b–15 [17 CFR document authenticating, acknowledging, or 240.12b–15] and Investment Company Act Rule 8b– otherwise adopting the signature that appears in IV. Paperwork Reduction Act 15 [17 CFR 270.8b–15]. Depending on the contents typed form within the electronic version of this of the amendment, the form of certification required written statement required by Section 906, has been A. Background to be included may be subject to modification. provided to [name of issuer] and will be retained 155 See Exchange Act Rules 13a–14(b) and 15d– by [name of issuer] and furnished to the Securities Certain provisions of our final 14(b) [17 CFR 240.13a–14(b) and 240.15d–14(b)] and Exchange Commission or its staff upon amendments contain ‘‘collection of and Investment Company Act Rule 30a–2(b) [17 request.’’ information’’ requirements within the CFR 270.30a–2(b)]. 158 Use of Exhibit 99 for this purpose will remain meaning of the Paperwork Reduction 156 See Release No. 33–8212 (Mar. 21, 2003) [68 in effect until we announce that our EDGAR system 160 FR 15600] at Section III. permits registrants to file or furnish exhibits 31 and Act of 1995 (‘‘PRA’’). We published 157 We are modifying that interim guidance, 32 for Section 302 and 906 certifications. We will a notice requesting comment on the however, to more closely parallel the provisions of issue a statement and post it on the Commission’s collection of information requirements Section 302 of Regulation S–T that require retention website to announce this date as soon as it becomes in the proposing release for the rule of manual signatures for electronically filed signed known. amendments, and we submitted these statements. Issuers furnishing Section 906 159 For a registered management investment certifications to the Commission as an exhibit to the company filing reports on Form N–CSR, the EDGAR requirements to the Office of periodic reports to which they relate during the document type should be EX–99.906CERT for the period covered by the interim guidance should Section 906 certifications. 160 44 U.S.C. 3501 et seq.

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Management and Budget (‘‘OMB’’) for over financial reporting for the reporting.164 However, few of these review in accordance with the PRA.161 company; commenters provided actual alternative The titles for the collection of • A statement identifying the cost estimates, and none provided information are: framework used by management to estimates that could be applied (1) ‘‘Form 10–Q’’ (OMB Control No. evaluate the effectiveness of the generally to all types and sizes of 3235–0070); company’s internal control over companies. One commenter believed (2) ‘‘Form 10–QSB’’ (OMB Control No. financial reporting; that, based on its experience, we 3235–0416); • Management’s assessment of the understated the burden estimate by at (3) ‘‘Form 10–K’’ (OMB Control No. effectiveness of the company’s internal least a factor of 100.165 In response to 3235–0063); control over financial reporting, as of these commenters, and based on follow- (4) ‘‘Form 10–KSB’’ (OMB Control No. the end of the most recent fiscal year; up conversations with several of the 3235–0420); and commenters who expressed a view on (5) ‘‘Form 20–F’’ (OMB Control No. • A statement that the registered our burden and cost estimates, we have 3235–0288); public accounting firm that audited the revised our estimates as discussed more (6) ‘‘Form 40–F’’ (OMB Control No. financial statements included in the fully in Section IV.D below. 3235–0381); annual report has issued an attestation We have made a substantive (7) ‘‘Regulation S–X’’ (OMB Control report on management’s evaluation of modification to the proposed rules in No. 3235–0009); the company’s internal control over response to the cost concerns expressed (8) ‘‘Regulation S–K’’ (OMB Control financial reporting. by commenters. Specifically, the final No. 3235–0071); rules require companies to undertake a (9) ‘‘Regulation S–B’’ (OMB Control We are adding these requirements pursuant to the legislative mandate in quarterly evaluation only of any change No. 3235–0417); and occurring during the fiscal quarter that (10) ‘‘Form N–CSR’’ (OMB Control Section 404 of the Sarbanes-Oxley Act. Under our final rules, a company also has materially affected, or is reasonably No. 3235–0570). likely to materially affect, the The forms are periodic reports will be required to evaluate and disclose any change in its internal control over company’s internal control over adopted under the Exchange Act and financial reporting. This change should the Investment Company Act. The financial reporting that occurred during the fiscal quarter that has materially substantially mitigate some of the costs regulations set forth the disclosure and burdens associated with the requirements for periodic reports, affected, or is reasonably likely to materially affect, the company’s internal proposed requirements. registration statements and proxy and We have made additional substantive control over financial reporting. information statements filed by changes to the proposed rule as well. companies to ensure that investors are We are also adopting amendments to First, the final rules require informed. The hours and costs require companies to file the management to evaluate the company’s associated with preparing, filing and certifications mandated by Sections 302 internal control over financial reporting sending these forms constitute reporting and 906 of the Sarbanes-Oxley Act as using a suitable framework, such as the and cost burdens imposed by each exhibits to their annual, semi-annual COSO Framework. Second, the final collection of information. An agency and quarterly reports. These rules expand the list of information that may not conduct or sponsor, and a amendments will enhance the ability of must be included in the management person is not required to respond to, a investors, the Commission staff, the report and specify that management collection of information unless it Department of Justice and other cannot conclude that a company’s displays a currently valid OMB control interested parties to easily and internal control over financial reporting number. Compliance with the efficiently access the certifications is effective if there are one or more requirements is mandatory. Under our through our Electronic Data Gathering, material weaknesses in such control. rules for the retention of manual Analysis and Retrieval (‘‘EDGAR’’) Under the final rules, management must signatures,162 companies must retain, system and facilitate better monitoring identify the framework used to evaluate for a period of five years, an original of a company’s compliance with the the company’s internal control over signature page or other document certification requirements. financial reporting and disclose any authenticating, acknowledging or C. Summary of Comment Letters and material weaknesses in the company’s otherwise adopting the certifying Revisions to Proposals internal control over financial reporting officers’ signatures that appear in their discovered through the evaluation. We electronically filed periodic reports. We requested comment on the PRA do not believe that these changes Responses to the information collections analysis contained in the proposing significantly alter the burdens imposed are not kept confidential. releases addressing Section 404 and on companies resulting from the Sections 302 and 906 of the Sarbanes- B. Summary of the Final Rules 163 required assessment of internal control Oxley Act. We received no comments over financial reporting. The final rules require the annual on our PRA estimates for the report of every company that files certification requirements. With respect D. Revisions to PRA Reporting and Cost periodic reports under Section 13(a) or to our PRA estimates for the rules Burden Estimates 15(d) of the Exchange Act, other than implementing Section 404 of the As discussed above, in consideration reports by registered investment Sarbanes-Oxley Act, eight commenters of commenters’ remarks, we are revising companies, to contain a report of thought that our PRA estimates our PRA burden and cost estimates for management that includes: significantly understated the actual time the rules pertaining to Section 404 that • A statement of management’s and costs that companies would have to we originally submitted to the OMB in responsibility for establishing and expend evaluating and reporting on connection with the proposed rules. maintaining adequate internal control their internal control over financial 164 164 See letters regarding File No. S7–40–02 of: 161 44 U.S.C. 3507(d) and 5 CFR 1320.11. 163 See Release No. 33–8138 (Oct. 22, 2002) [67 AICPA; BDO; D&T; Emerson; E&Y; IPC; Intel; and 162 See Rule 302 of Regulation S–T [17 CFR FR 66208] and Release No. 33–8212 (Mar. 21, 2003) NYCB–CCL. 232.302]. [68 FR 15600]. 165 See Intel letter regarding File No. S7–40–02.

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We derived our new burden hour average incremental burden for an each quarterly report. Accordingly, we estimates for the annual report forms by annual filing will be 383 hours per did not revise our original burden hour estimating the total amount of time that company and the portion of that burden estimates for the quarterly report forms. it will take a company’s management to that is reflected as the cost associated We estimate the total annual conduct the annual evaluation of its with outside professionals is incremental burden (for annual and internal control over financial reporting approximately $34,300 per company. quarterly reports) associated with the and to prepare the required management For large corporations, we expect that new internal control evaluation and report.166 Our annual burden estimate is this burden will be substantially higher. disclosure requirements for all based on several assumptions. First, we Indeed, we received estimates in the companies to be approximately assumed that the annual number of thousands of hours for some large and 3,792,888 hours of company personnel responses for each form would be complex companies. Conversely, we time and a cost of $481,013,550 for the consistent with the number of filings expect small companies to find their services of outside professionals.169 that we received in fiscal year 2002.167 burden to be less than this average. We also believe that many companies will Table 1 below presents these burdens Second, we assumed that there is a and costs for each form affected by the direct correlation between the extent of experience costs well in excess of this average in the first year of compliance final rules implementing Section 404 of the burden and the size of the reporting Sarbanes-Oxley. We calculated the company, with the burden increasing with the final rules. We believe that costs will decrease in subsequent years. burden by multiplying the estimated commensurate with the size of the This burden will also vary among number of affected responses by the company. We believe that there will be companies based on the complexity of estimated average number of hours that a marked disparity of burdens and costs their organization and the nature of management will spend conducting its resulting from the new internal control their current internal control assessment of the company’s internal requirements between the largest and procedures. We therefore calculated our control over financial reporting and smallest reporting companies. Our estimates by averaging the estimated preparing the related disclosure. For estimates reflect an average burden for burdens over a three-year period. Exchange Act annual reports, we all sizes of companies. Third, we We derived our burden estimates for estimate that 75% of the burden of assumed that the first-year burden the quarterly report forms by estimating preparation is carried by the company would be greater than that for the total amount of time that it will take internally and that 25% of the burden subsequent years, as a portion of the a company’s management to conduct of preparation is carried by outside costs will reflect one-time expenditures the quarterly evaluation of material professionals retained by the company associated with complying with the changes to the company’s internal at an average cost of $300 per hour.170 rule, such as compiling documentation, control over financial reporting and for The portion of the burden carried by implementing new processes, and the company to prepare the required outside professionals is reflected as a training staff. We also adjusted the disclosure about such changes. We cost, while the portion of the burden second and third year estimates to believe that these quarterly evaluations carried by the company internally is account for the fact that management will impose little additional burden, as reflected in hours. There is no change to should become more efficient at much of the structure to conduct these the estimated burden of the collections conducting its internal control evaluations will be established in of information entitled ‘‘Regulation S– assessment and preparing the disclosure connection with the annual evaluations. K,’’ ‘‘Regulation S–B’’ and ‘‘Regulation after the first year as the process We estimate that the quarterly reporting S–X’’ because the burdens that these becomes more routine.168 Under these will impose an additional burden of five regulations impose are reflected in our assumptions, we estimate that the hours per company in connection with revised estimates for the forms.

TABLE 1.—INCREMENTAL PAPERWORK BURDEN FOR THE RULES IMPLEMENTING SECTION 404

25% Professional Annual re- Incremental Total burden 75% Company Professional costs sponses (A) hours/form (B) (C)=(A)*(B) (D)=(C)*0.75 (E)=(C)*0.25 (F)=(E)*$300

10–K ...... 8,484 383 3,249,372 2,437,029 812,343 243,702,900 10–KSB ...... 3,820 383 1,463,606 1,097,295 365,765 109,729,500 20–F ...... 1,194 383 457,302 114,326 342,977 102,892,950 40–F ...... 134 383 51,322 12,831 37,989 11,547,450 10–Q ...... 23,743 5 118,715 89,036 29,679 8,903,625 10–QSB ...... 11,299 5 56,495 42,371 14,124 4,237,125 Reg. S–K...... N/A 1 1 N/A N/A N/A Reg. S–B...... N/A 1 1 N/A N/A N/A Reg. S–X...... N/A 1 1 N/A N/A N/A

Total ...... 3,792,888 ...... $481,013,550

166 Our estimates are based on information from 169 Our PRA estimates do not include any estimated 0.5 hour burden in our revised annual with several large and small firms, accounting firms additional burdens or costs that a company will burden estimates to account for the filing by the and trade and professional associations. incur as a result of having to obtain an auditor’s company of the attestation report. 167 The estimates used in the releases proposing attestation report on management’s internal control 170 The burden allocation for Forms 20–F and 40– these rules were based on the number of filings that report because the PCAOB, rather than the F, however, use a 25% internal to 75% outside we received in fiscal year 2001. Commission, is responsible for establishing the professional allocation to reflect the fact that foreign 168 We assumed the estimated burdens in the attestation standards and the Sarbanes-Oxley Act second and third years would decline by 75% from itself requires companies to obtain such an private issuers rely more heavily on outside the first year estimate. attestation. We have, however, included an professionals for the preparation of these forms.

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We do not believe that the reports and for Form N–CSR based on amendments relating to the Section 906 amendments with respect to the Section the amendment with respect to the certifications would result in an 302 certifications result in a need to Section 906 certification.171 The PRA increase of one burden hour per alter the burden estimates that we estimates for these amendments do not portfolio.172 We estimate that there are previously submitted to OMB because reflect a cost because we believe that the approximately 3,700 registered they merely relocate the certifications entire burden will be borne by company management investment companies that from the text of quarterly and annual personnel. With respect to semi-annual are required to file reports on Form N– reports filed or submitted under Section reports on Form N–CSR, because the CSR, containing 9,850 portfolios. The 13(a) or 15(d) of the Exchange Act to the financial statements of registered following table illustrates the ‘‘Exhibits’’ section of the reports. We management investment companies are incremental PRA estimates for the new are, however, revising the burden not as complex as those of operating Section 906 certification 173 estimates for quarterly and annual companies, we estimate that the requirements:

TABLE 2.—INCREMENTAL PAPERWORK BURDEN FOR CERTIFICATION REQUIREMENTS

Annual Total hours Form responses Hours/form added

20–F ...... 1,194 2 2,388 40–F ...... 134 2 268 10–K ...... 8,484 2 16,968 10–KSB ...... 3,820 2 7,640 10–Q ...... 23,743 2 47,486 10–QSB ...... 11,299 2 22,598 N–CSR ...... 7,400 173 2.66 19,700

Total ...... 117,048

V. Cost-Benefit Analysis important responsibility of and perhaps thereby deter financial The amendments implementing management. An effective system of fraud or minimize its adverse effects. Section 404 of the Sarbanes-Oxley Act internal control over financial reporting All of these benefits will increase are congressionally mandated. We is necessary to produce reliable market efficiency by improving investor recognize that implementation of the financial statements and other financial confidence in the reliability of a Sarbanes-Oxley Act will likely result in information used by investors. By company’s financial disclosure and costs and benefits to the economy. We requiring a report of management stating system of internal control over financial are sensitive to the costs and benefits management’s responsibility for the reporting. These benefits are not readily imposed by our rules, and we have company’s financial statements and quantifiable. Commenters considered costs and benefits of our internal control over financial reporting overwhelmingly supported the benefits amendments. and management’s assessment regarding of the amendments. the effectiveness of such control, The amendments related to Section A. Benefits investors will be able to better evaluate 302 of the Sarbanes-Oxley Act relocate One of the main goals of the Sarbanes- management’s performance of its the certifications required by Exchange Oxley Act is to enhance the quality of stewardship responsibilities and the Act Rules 13a-14 and 15d-14 from the reporting and increase investor reliability of a company’s financial text of quarterly and annual reports filed confidence in the financial markets. statements and other unaudited or submitted under Section 13(a) or Recent market events have evidenced a financial information. 15(d) of the Exchange Act to the need to provide investors with a clearer The required annual evaluation of ‘‘Exhibits’’ section of these reports. The understanding of the processes that internal control over financial reporting amendments related to Section 906 of surround the preparation and will encourage companies to devote the Sarbanes-Oxley Act require that the presentation of financial information. adequate resources and attention to the certifications required by Section 1350 These amendments are intended to maintenance of such control. of Title 18 of the United States Code, accomplish the Act’s goals by improving Additionally, the required evaluation added by Section 906 of the Act, public company disclosure to investors should help to identify potential accompany the periodic reports to about the extent of management’s weaknesses and deficiencies in advance which they relate as exhibits. These responsibility for the company’s of a system breakdown, thereby changes will enhance the ability of financial statements and internal control facilitating the continuous, orderly and investors and the Commission staff to over financial reporting and the means timely flow of information within the verify that the certifications have, in by which management discharges its company and, ultimately, to investors fact, been submitted with the Exchange responsibility. The establishment and and the marketplace. Improved Act reports to which they relate and to maintenance of internal control over disclosure may help companies detect review the contents of the certifications financial reporting has always been an fraudulent financial reporting earlier to ensure compliance with the

171 While Section 906 of the Sarbanes-Oxley Act consistently submitted the certifications as part of than a registered management investment company requires that certifications must accompany a the report. basis. periodic report, we are increasing our PRA burdens 172 Many registered management investment 173 This number represents the burden associated in view of the fact that the amendments explicitly companies have multiple portfolios. However, they with the average number of portfolios per form. require companies to furnish Section 906 prepare separate financial statements for each This number will vary for each registered certifications as exhibits to these reports. To date, management investment company depending on portfolio. Thus, the burden of the Section 906 companies have used various methods to fulfill the number of portfolios. We estimate that the their obligations under Section 906, and have not certifications is estimated on a portfolio basis rather paperwork burden for each portfolio is one hour.

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applicable requirements. In addition, billion (or $91,000 per company).174 We firms from seeking capital in the United the changes will enable the Department recognize the magnitude of the cost States. of Justice, which has responsibility for burdens and we are making several The incremental costs of the enforcing Section 906, to review accommodations to address amendments related to Section 302 of effectively the form and content of the commenters’ concerns and to ease the Sarbanes-Oxley Act are minimal. certifications required by that section. compliance, including: Since companies must already include • Requiring quarterly disclosure only B. Costs the certifications required by Exchange of any change that has materially Act Rules 13a-14 and 15d-14 in their affected, or is reasonably likely to The final rules related to Section 404 quarterly and annual reports, there of the Sarbanes-Oxley Act require materially affect, a company’s internal should be no incremental cost to companies, other than registered control over financial reporting; and relocating the certifications from the investment companies, to include in • An extended transition period for text of the reports to the ‘‘Exhibits’’ their annual reports a report of the new internal control reporting section of these reports. Requiring the management on the company’s internal requirements. Section 906 certifications to be included control over financial reporting. The We originally proposed to require a as an exhibit to the periodic reports to management report on internal control company to include an internal control which they relate will lead to some over financial reporting must include: a report in its annual report for fiscal additional costs for companies that statement of management’s years ending on or after September 15, currently are submitting the responsibility for establishing and 2003. Under the final rules, a company certifications to the Commission in maintaining adequate internal control that is an ‘‘accelerated filer’’ under the over financial reporting; a statement definition in Exchange Act Rule 12b-2 some other manner. While these costs identifying the framework used to must begin to comply with the internal are difficult to quantify, we estimate evaluate the effectiveness of the control report requirement in its annual that the annual paperwork burden of the report for its first fiscal year ending on amendments will be approximately company’s internal control over 175 financial reporting; management’s or after June 15, 2004. All other $23.4 million. assessment of the effectiveness of the companies must begin to comply with One commenter has expressed company’s internal control over the requirement in their annual reports concern that companies may assume financial reporting as of the end of the for their first fiscal year ending on or greater legal risk by making their company’s most recent fiscal year; and after April 15, 2005. Section 906 certifications publicly a statement that the registered public A longer transition period will help to available.176 To the extent that accounting firm that audited the alleviate the immediate impact of any companies may assume greater legal risk company’s financial statements costs and burdens imposed on by including the Section 906 included in the annual report has issued companies. A longer transition period certifications as part of their periodic an attestation report on management’s may even help to reduce costs as reports filed pursuant to the Exchange evaluation of the company’s internal companies will have additional time to Act where these reports are control over financial reporting. The develop best practices, long-term incorporated by reference into final rules will increase costs for all processes and efficiencies in preparing Securities Act registration statements, reporting companies. These costs are management reports. Also, a longer we address this risk by requiring mitigated somewhat because companies transition period will expand the period companies to ‘‘furnish,’’ rather than have an existing obligation to maintain of availability of outside professionals ‘‘file,’’ the certifications with the an adequate system of internal that some companies may wish to retain Commission for purposes of Section 18 accounting control under the FCPA. as they prepare to comply with the new of the Exchange Act or incorporation by Moreover, one commenter noted that requirements. reference into other filings. Thus, the some companies already voluntarily The PRA burden estimate, however, amendments should mitigate this include management reports on their excludes several costs attributable to potential indirect cost of compliance. internal controls in their annual reports. Section 404. The estimate does not We believe that it is appropriate to The preparation of the management include the costs associated with the require the certifications that report on internal control over financial auditor’s attestation report, which many accompany a periodic report to be reporting will likely involve multiple commenters have suggested might be publicly available. We believe that parties, including senior management, substantial. It also excludes estimates of Congress intended for Section 906 internal auditors, in-house counsel, likely ‘‘indirect’’ costs of the final rules. certifications to be publicly available. outside counsel and audit committee For instance, the final rules increase the Civil liability already exists by virtue of members. cost of being a public company; the pre-existing signature requirements Many commenters believed that our therefore the final rules may discourage and Section 302 certifications. In proposal to require quarterly some companies from seeking capital addition, any Section 906 certification evaluations of a company’s internal from the public markets. Moreover, the submitted to the Commission as control over financial reporting would final rules may also discourage non-U.S. correspondence is subject to the significantly increase the costs of Freedom of Information Act.177 preparing periodic reports. Several 174 This estimate is based on the estimated total burden hours of 5,396,266, an assumed 75%/25% commenters also were concerned that split of the burden hours between internal staff and 175 This calculation is based on an estimate of the proposals would result in increased external professionals, and an hourly rate of $200 burden hours multiplied by a cost of $200.00 per audit fees. We have limited data on for internal staff time and $300 for external hour. (117,048 hours multiplied by $200.00 per hour). The hourly cost estimate is based on which to base cost estimates of the final professionals. The hourly cost estimate is based on consultations with several registrants and law firms consultations with several registrants and law firms rules. and other persons who regularly assist registrants and other persons who regularly assist registrants Using our PRA burden estimates, we in preparing and filing periodic reports with the in preparing and filing periodic reports with the estimate the aggregate annual costs of Commission. Our PRA estimate does not reflect any Commission. additional cost burdens that a company will incur 176 176 See ABA letter regarding File No. S7–06– implementing Section 404(a) of the as a result of having to obtain an auditor’s 03. Sarbanes-Oxley Act to be around $1.24 attestation on management’s internal control report. 177 5 U.S.C. 552 et seq.

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VI. Effect on Efficiency, Competition fact, been submitted with the Exchange an attestation report on management’s and Capital Formation Act reports to which they relate and to evaluation of the company’s internal Section 23(a)(2) of the Exchange review the contents of the certifications control over financial reporting. This Act 178 requires us to consider the anti- to ensure compliance with the FRFA also addresses new rules and competitive effects of any rules that we applicable requirements. The amendments that require companies to adopt under the Exchange Act. In amendments related to Section 906 of file the certifications mandated by addition, Section 23(a)(2) prohibits us the Sarbanes-Oxley Act also will Sections 302 and 906 of the Sarbanes- from adopting any rule that would streamline compliance with Section Oxley Act as exhibits to their periodic impose a burden on competition not 1350 of Title 18 of the United States reports. An Initial Regulatory Flexibility necessary or appropriate in furtherance Code, added by Section 906 of the Act, Analysis (‘‘IRFA’’) was prepared in of the purposes of the Exchange Act. and will enable investors, the accordance with the Regulatory The amendments related to Section 404 Commission staff and the Department of Flexibility Act in conjunction with each 183 of the Sarbanes-Oxley Act represent the Justice, which has responsibility for of the releases proposing these rules. implementation of a congressional enforcing Section 1350, to verify The proposing releases solicited mandate. The final rules require submission and efficiently review the comments on these analyses. form and content of the certifications management reports that improve A. Need for the Amendments investors’ understanding of required by that provision. We are adopting these disclosure management’s responsibility for the We do not believe that the requirements to comply with the preparation of reliable financial amendments related to certifications mandate of, and to fulfill the purposes information and maintaining adequate will impose any burden on competition, underlying the provisions of, the internal control over financial reporting. nor are we aware of any impact on Sarbanes-Oxley Act of 2002. The new We anticipate that these requirements capital formation that would result from evaluation and disclosure requirements will enhance the proper functioning of the amendments. Depending on how an regarding a company’s internal control the capital markets by increasing the issuer’s principal executive and over financial reporting are intended to quality and accountability of financial principal financial officers presently enhance the quality of reporting and reporting and restoring investor satisfy the Section 906 certification increase investor confidence in the confidence. requirements, issuers may incur some Section 2(b) of the Securities Act,179 additional costs in submitting these fairness and integrity of the securities Section 3(f) of the Exchange Act 180 and certifications as an exhibit to their markets by making it clear that a Section 2(c) of the Investment Company periodic reports. While these costs are company’s management is responsible Act 181 require us, when engaging in difficult to quantify, we believe that for maintaining and annually assessing rulemaking to consider or determine they would be nominal. We requested such controls. The amendments related whether an action is necessary or comment on whether the amendments to Sections 302 and 906 of the Sarbanes- appropriate in the public interest, and would affect competition, efficiency and Oxley Act will enhance the ability of consider whether the action will capital formation. We received no investors and the Commission staff to promote efficiency, competition, and comments in response to this request. verify that the certifications have, in capital formation. The amendments fact, been submitted with the Exchange VII. Final Regulatory Flexibility Act reports to which they relate and to related to Section 404 are designed to Analysis enhance the quality and accountability review the contents of the certifications This Final Regulatory Flexibility of the financial reporting process and to ensure compliance with the Analysis (‘‘FRFA’’) has been prepared in may help increase investor confidence, applicable requirements. The accordance with the Regulatory which implies increased efficiency and amendments also will streamline Flexibility Act.182 This FRFA relates to competitiveness of the U.S. capital compliance with Section 1350 of Title new rules and amendments that require markets. Increased market efficiency 18 of the United States Code and will Exchange Act companies, other than and investor confidence also may enable investors, the Commission staff registered investment companies, to encourage more efficient capital and the Department of Justice, which include in their annual reports a report formation. We requested comments on has responsibility for enforcing Section of management on the company’s the effect of these amendments on 1350, to verify a company’s submission internal control over financial reporting. efficiency, competition and capital of the Section 906 certification and The management report on internal formation analyses in the proposing efficiently review the form and content control over financial reporting must release addressing Section 404. We of the certifications. include: a statement of management’s received no comments in response to responsibility for establishing and B. Significant Issues Raised by Public these requests. Comment The amendments related to Section maintaining adequate internal control 302 of the Sarbanes-Oxley Act would over financial reporting; a statement In the Proposing Releases, we relocate the certifications required by identifying the framework used to requested comment on any aspect of the Exchange Act Rules 13a–14 and 15d–14 evaluate the effectiveness of the IRFA, including the number of small from the text of quarterly and annual company’s internal control over entities that would be affected by the reports filed or submitted under Section financial reporting; management’s proposals, and both quantitative and 13(a) or 15(d) of the Exchange Act to the assessment of the effectiveness of the qualitative nature of the impact. Several ‘‘Exhibits’’ section of these reports. This company’s internal control over commenters expressed concern that relocation will enhance the ability of financial reporting as of the end of the small business issuers, including small investors and the Commission staff to company’s most recent fiscal year; and entities, would be particularly verify that the certifications have, in a statement that the registered public disadvantaged by our proposal to accounting firm that audited the require quarterly evaluations of internal 178 15 U.S.C. 78w(a)(2). company’s financial statements control over financial reporting. We 179 15 U.S.C 77b(b). included in the annual report has issued received no commentary on the impact 180 15 U.S.C. 78c(f). 181 15 U.S.C. 80a–2(c). 182 5 U.S.C. 601. 183 5 U.S.C. 603.

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on small entities of the new certification necessarily are required to prepare the based on a company’s size. We think requirements. new disclosure, although some that improvements in the financial companies may choose to engage reporting process for all companies are C. Small Entities Subject to the outside professionals to assist them in important for promoting investor Amendments complying with the new requirements. confidence in our markets. For example, The new disclosure items affect We expect that these new disclosure a 1999 report commissioned by the issuers that are small entities. Exchange items will increase compliance costs organizations that sponsored the Act Rule 0–10(a) 184 defines an issuer, incurred by small entities. We have Treadway Commission found that the other than an investment company, to calculated for purposes of the incidence of financial fraud was greater be a ‘‘small business’’ or ‘‘small Paperwork Reduction Act that each in small companies.190 However, we are organization’’ if it had total assets of $5 company would be subject to an added sensitive to the costs and burdens that million or less on the last day of its most annual reporting burden of small entities will face. The final rules recent fiscal year. We estimate that there approximately 398 hours and the require only a quarterly evaluation of are approximately 2,500 issuers, other portion of that burden that is reflected material changes to a company’s than investment companies, that may be as the cost associated with outside internal control over financial reporting, considered small entities. For purposes professionals is approximately unlike the proposed rules that would of the Regulatory Flexibility Act, an $35,286.187 We believe, however, that have required management to evaluate investment company is a ‘‘small entity’’ the annual average burden and costs for the effectiveness of a company’s internal if it, together with other investment small issuers are much lower.188 For the control over financial reporting on a companies in the same group of related new certification requirements, we quarterly basis. In response to investment companies, has net assets of estimate that a company, including a comments, including comments $50 million or less as of the end of its small entity, will be subject to an submitted by the Small Business most recent fiscal year.185 We estimate additional reporting burden of eight Administration, we have decided not to that there are approximately 190 hours per year.189 These burden adopt this proposal. registered management investment estimates reflect only the burden and We believe that a blanket exemption companies that, together with other cost of the required collection of for small entities from coverage of the investment companies in the same information. requirements is not appropriate and group of related investment companies, would be inconsistent with the policies have net assets of $50 million or less as E. Agency Action to Minimize Effect on underlying the Sarbanes-Oxley Act. of the end of the most recent fiscal Small Entities However, we have provided an year.186 The Regulatory Flexibility Act directs extended transition period for The new disclosure items with us to consider alternatives that would companies that do not meet the respect to management’s report on accomplish our stated objectives, while definition in Exchange Act Rule 12b– internal control over financial reporting minimizing any significant adverse 2 191 of an ‘‘accelerated filer’’ for the and the registered public accounting impact on small entities. In connection rules implementing Section 404 of the firm’s attestation report apply to any with the amendments, we considered Sarbanes-Oxley Act. Under the adopted small entity, other than a registered the following alternatives: rules, non-accelerated filers, including investment company, that is subject to • Establishing different compliance or small business issuers, need not prepare Exchange Act reporting requirements. reporting requirements or timetables the management report on internal The new certification requirements that take into account the resources control over financial reporting until apply to any small entity that is subject available to small entities; they file their annual reports for fiscal • to Exchange Act reporting requirements. Clarifying, consolidating or years ending on or after April 15, 2005. simplifying compliance and reporting This deferral provides non-accelerated D. Reporting, Recordkeeping and Other requirements under the rules for small Compliance Requirements filers more time to develop structured entities; and formal systems of internal control • The amendments require a company’s Using performance rather than over financial reporting. management to disclose information design standards; and We believe that the new disclosure • regarding the company’s internal Exempting small entities from all or and certification requirements are clear control over financial reporting, part of the requirements. and straightforward. The amendments including management’s assessment of Several of these alternatives were require only brief disclosure. An the effectiveness of the company’s considered but rejected, while other effective system of internal control over internal control over financial reporting. alternatives were taken into account in financial reporting has always been All small entities that are subject to the the final rules. We believe the final rules necessary to produce reliable financial reporting requirements of Section 13(a) fulfill the intent of the Sarbanes-Oxley statements and other financial or 15(d) of the Exchange Act, other than Act of enhancing the quality of information. Our amendments do not registered investment companies, are reporting and increasing investor specify any particular controls that a subject to these evaluation and confidence in the fairness and integrity company’s internal control over disclosure requirements. Because of the securities markets. financial reporting should include. Each Sections 302, 404 and 906 of the reporting companies already file the company is afforded the flexibility to Sarbanes-Oxley Act make no distinction forms being amended, no additional design its internal control over financial professional skills beyond those reporting according to its own set of 187 This estimate includes the burden for one currently possessed by these filers annual report and three quarterly reports. circumstances. This flexibility should 188 Under the method we used to estimate the 184 17 CFR 240.0–10(a). PRA burdens associated with the Section 404 rules, 190 See Beasley, Carcello and Hermanson, 185 17 CFR 270.0–10. we estimated that companies with less than $100 Fraudulent Financial Reporting: 1987–1997, An 186 This estimate is based on figures compiled by million in revenues would be subject to an added Analysis of U.S. Public Companies (Mar. 1999) the Commission staff regarding investment annual reporting burden of approximately 100 (study commissioned by the Committee of companies registered on Forms N–1A, N–2 and N– hours. Sponsoring Organizations of the Treadway 3, which are required to file reports on Form N– 189 The estimated burden for one annual report Commission). CSR. and three quarterly reports. 191 17 CFR 240.12b–2.

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enable companies to keep costs of PART 210—FORM AND CONTENT OF (c) Opinions to be expressed in compliance as low as possible. AND REQUIREMENTS FOR FINANCIAL accountants’ reports. *** Therefore, it does not seem necessary to STATEMENTS, SECURITIES ACT OF (d) Exceptions identified in develop separate requirements for small 1933, SECURITIES EXCHANGE ACT accountants’ reports. *** entities. OF 1934, PUBLIC UTILITY HOLDING * * * * * The final rules impose both design COMPANY ACT OF 1935, INVESTMENT (f) Attestation report on COMPANY ACT OF 1940, INVESTMENT management’s assessment of internal and performance standards regarding ADVISERS ACT OF 1940, AND control over financial reporting. Every disclosure of management’s ENERGY POLICY AND registered public accounting firm that responsibility for establishing and CONSERVATION ACT OF 1975 issues or prepares an accountant’s maintaining adequate internal control report for a registrant, other than an ■ over financial reporting for the company 1. The authority citation for Part 210 is investment company registered under and management’s assessment of the revised to read as follows: section 8 of the Investment Company effectiveness of such controls. The rules Authority: 15 U.S.C. 77f, 77g, 77h, 77j, 77s, Act of 1940 (15 U.S.C. 80a–8), that is do, however, afford a company the 77z–2, 77z–3, 77aa(25), 77aa(26), 78c, 78j–1, included in an annual report required flexibility to design its internal control 78l, 78m, 78n, 78o(d), 78q, 78u–5, 78w(a), by section 13(a) or 15(d) of the over financial reporting to fit its 78ll, 78mm, 79e(b), 79j(a), 79n, 79t(a), 80a– Securities Exchange Act of 1934 (15 particular circumstances. We believe 8, 80a–20, 80a–29, 80a–30, 80a–31, 80a– U.S.C. 78a et seq.) containing an that it would be inconsistent with the 37(a), 80b–3, 80b–11, 7202 and 7262, unless otherwise noted. assessment by management of the purposes of the Sarbanes-Oxley Act to ■ effectiveness of the registrant’s internal specify different requirements for small 2. Section 210.1–02 is amended by: control over financial reporting must ■ a. Removing the authority citation entities. attest to, and report on, such following § 210.1–02; ■ assessment. The attestation report on VIII. Statutory Authority and Text of b. Redesignating paragraph (a) as management’s assessment of internal Rule Amendments paragraph (a)(1); and ■ control over financial reporting shall be c. Adding paragraph (a)(2). dated, signed manually, identify the The amendments described in this The revisions read as follows: release are being adopted under the period covered by the report and clearly state the opinion of the accountant as to authority set forth in Sections 5, 6, 7, 10, § 210.1–02 Definitions of terms used in Regulation S–X (17 CFR part 210). whether management’s assessment of 17 and 19 of the Securities Act, as the effectiveness of the registrant’s amended, Sections 12, 13, 15, 23 and 36 * * * * * (a)(1) * * * internal control over financial reporting of the Exchange Act, Sections 8, 30, 31 is fairly stated in all material respects, and 38 of the Investment Company Act, (2) Attestation report on management’s assessment of internal or must include an opinion to the effect as amended and Sections 3(a), 302, 404, that an overall opinion cannot be 405 and 906 of the Sarbanes-Oxley Act. control over financial reporting. The term attestation report on expressed. If an overall opinion cannot List of Subjects management’s assessment of internal be expressed, explain why. The control over financial reporting means a attestation report on management’s 17 CFR Part 210 report in which a registered public assessment of internal control over accounting firm expresses an opinion, financial reporting may be separate from Accountants, Accounting, Reporting the accountant’s report. and recordkeeping requirements, or states that an opinion cannot be expressed, concerning management’s Securities. PART 228—INTEGRATED assessment of the effectiveness of the DISCLOSURE SYSTEM FOR SMALL 17 CFR Part 228 registrant’s internal control over BUSINESS ISSUERS financial reporting (as defined in Reporting and recordkeeping § 240.13a–15(f) or 240.15d–15(f) of this ■ 4. The general authority citation for requirements, Securities, Small chapter) in accordance with standards Part 228 is revised to read as follows: businesses. on attestation engagements. When an overall opinion cannot be expressed, the Authority: 15 U.S.C. 77e, 77f, 77g, 77h, 77j, 17 CFR Parts 229, 240 and 249 77k, 77s, 77z–2, 77z–3, 77aa(25), 77aa(26), registered public accounting firm must 77ddd, 77eee, 77ggg, 77hhh, 77jjj, 77nnn, Reporting and recordkeeping state why it is unable to express such an 77sss, 78l, 78m, 78n, 78o, 78u–5, 78w, 78ll, requirements, Securities. opinion. 78mm, 80a–8, 80a–29, 80a–30, 80a–37, 80b– * * * * * 11, 7202, 7241, and 7262; and 18 U.S.C. 17 CFR Parts 270 and 274 ■ 3. Amend § 210.2–02 by: 1350, unless otherwise noted. Investment companies, Reporting and ■ a. Revising the section heading; * * * * * recordkeeping requirements, Securities. ■ b. Revising the headings of paragraphs ■ 5. Revise § 228.307 to read as follows: (a), (b), (c) and (d); and § 228.307 (Item 307) Disclosure controls Text of Amendments ■ c. Adding paragraph (f). and procedures. The addition and revisions read as ■ Disclose the conclusions of the small For the reasons set out in the preamble, follows. the Commission amends title 17, chapter business issuer’s principal executive II, of the Code of Federal Regulations as § 210.2–02 Accountants’ reports and and principal financial officers, or follows: attestation reports on management’s persons performing similar functions, assessment of internal control over regarding the effectiveness of the small financial reporting. business issuer’s disclosure controls and (a) Technical requirements for procedures (as defined in § 240.13a- accountants’ reports. *** 15(e) or 240.15d-15(e) of this chapter) as (b) Representations as to the audit of the end of the period covered by the included in accountants’ reports. *** report, based on the evaluation of these

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controls and procedures required by is not permitted to conclude that the the small business issuer’s internal paragraph (b) of § 240.13a-15 or small business issuer’s internal control control over financial reporting. 240.15d-15 of this chapter. over financial reporting is effective if Instructions to Item 308 ■ 6. Add § 228.308 to read as follows: there are one or more material weaknesses in the small business 1. The small business issuer must maintain § 228.308 (Item 308) Internal control over issuer’s internal control over financial evidential matter, including documentation, financial reporting. to provide reasonable support for reporting; and management’s assessment of the effectiveness (a) Management’s annual report on (4) A statement that the registered of the small business issuer’s internal control internal control over financial reporting. public accounting firm that audited the over financial reporting. Provide a report of management on the financial statements included in the 2. A small business issuer that is an Asset- small business issuer’s internal control annual report containing the disclosure Backed Issuer (as defined in § 240.13a-14(g) over financial reporting (as defined in required by this Item has issued an and § 240.15d-14(g) of this chapter) is not § 240.13a-15(f) or 240.15d-15(f) of this attestation report on management’s required to disclose the information required chapter) that contains: assessment of the small business by this Item. (1) A statement of management’s issuer’s internal control over financial § 228.401 [Amended] responsibility for establishing and reporting. maintaining adequate internal control (b) Attestation report of the registered ■ 7. Amend § 228.401 by removing the over financial reporting for the small public accounting firm. Provide the phrase ‘‘internal controls and procedures business issuer; registered public accounting firm’s for financial reporting’’ in paragraph (2) A statement identifying the attestation report on management’s (e)(2)(iv) of Item 401 and adding, in its framework used by management to assessment of the small business place, the phrase ‘‘internal control over evaluate the effectiveness of the small issuer’s internal control over financial financial reporting’’. business issuer’s internal control over reporting in the small business issuer’s ■ 8. Amend § 228.601 by: financial reporting as required by annual report containing the disclosure ■ a. Removing the last sentence of paragraph (c) of § 240.13a-15 or required by this Item. 240.15d-15 of this chapter; (c) Changes in internal control over paragraph (a)(1); (3) Management’s assessment of the financial reporting. Disclose any change ■ b. Revising the Exhibit Table; effectiveness of the small business in the small business issuer’s internal ■ c. Revising paragraph (b)(7) to read issuer’s internal control over financial control over financial reporting ‘‘No exhibit required.’’; reporting as of the end of the small identified in connection with the ■ d. Revising the heading in paragraph business issuer’s most recent fiscal year, evaluation required by paragraph (d) of (b)(11) to read ‘‘Statement re: including a statement as to whether or § 240.13a-15 or 240.15d-15 of this computation of per share earnings’’; and not internal control over financial chapter that occurred during the small ■ e. Revising paragraphs (b)(27) through reporting is effective. This discussion business issuer’s last fiscal quarter (the (b)(98). must include disclosure of any material small business issuer’s fourth fiscal ■ The revisions read as follows. weakness in the small business issuer’s quarter in the case of an annual report) internal control over financial reporting that has materially affected, or is § 228.601 (Item 601) Exhibits. identified by management. Management reasonably likely to materially affect, * * * * *

EXHIBIT TABLE

Securities act forms Exchange act forms

SB–2 S–2 S–3 S–4 3 S–8 10–SB 8–K 10–QSB 10–KSB

(1) Underwriting agreement ...... X X X X ...... X ...... (2) Plan of purchase, sale, reorganization, arrangement, liquidation or succession ...... X X X X ...... X X X X (3) (i) Articles of Incorporation ..... X ...... X ...... X ...... X X (ii) By-laws ...... X ...... X ...... X ...... X X (4) Instruments defining the rights of security holders, including indentures ...... X X X X XXXXX (5) Opinion on legality ...... X X X X X ...... (6) No exhibit required...... N/A N/A N/A N/A N/A N/A N/A N/A N/A (7) No exhibit required...... N/A N/A N/A N/A N/A N/A N/A N/A N/A (8) Opinion on tax matters ...... X X X X ...... (9) Voting trust agreement and amendments ...... X ...... X ...... X ...... X (10) Material contracts ...... X X ...... X ...... X ...... X X (11) Statement re: computation of per share earnings ...... X X ...... X ...... X ...... X X (12) No exhibit required...... N/A N/A N/A N/A N/A N/A N/A N/A N/A (13) Annual report to security holders for the last fiscal year, Form 10-Q or 10-QSB or quarterly report to security holders 1 X X ...... X ...... X (14) Code of ethics ...... X (15) Letter on unaudited interim financial information ...... X X X X X ...... X ......

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EXHIBIT TABLE—Continued

Securities act forms Exchange act forms

SB–2 S–2 S–3 S–4 3 S–8 10–SB 8–K 10–QSB 10–KSB

(16) Letter on change in certifying accountant 4 ...... X X ...... X ...... X X ...... X (17) Letter on director resignation ...... X ...... (18) Letter on change in accounting principles ...... X X (19) Reports furnished to security holders ...... X ...... (20) Other documents or statements to security holders or any document incorporated by reference ...... X X (21) Subsidiaries of the small business issuer ...... X ...... X ...... X ...... X (22) Published report regarding matters submitted to vote of security holders ...... X X (23) Consents of experts and counsel ...... X X X X X ...... X 2 X2 X2 (24) Power of attorney ...... X X XXXXXXX (25) Statement of eligibility of trustee ...... X X X X ...... (26) Invitations for competitive bids ...... XXXX...... (27) through (30) [Reserved] ...... (31) Rule 13a-14(a)/15d-14(a) Certifications ...... X X (32) Section 1350 Certifications ...... X X (33) through (98)[Reserved] ...... (99) Additional exhibits ...... X XXXXXXXX 1 Only if incorporated by reference into a prospectus and delivered to holders along with the prospectus as permitted by the registration statement; or in the case of a Form 10-KSB, where the annual report is incorporated by reference into the text of the Form 10-KSB. 2 Where the opinion of the expert or counsel has been incorporated by reference into a previously filed Securities Act registration statement. 3 An issuer need not provide an exhibit if: (1) an election was made under Form S–4 to provide S–2 or S–3 disclosure; and (2) the form selected (S–2 or S–3) would not require the company to provide the exhibit. 4 If required under Item 304 of Regulation S-B.

(b) Description of exhibits. * * * issuer as of, and for, the periods for external purposes in accordance (27) through (30) [Reserved] presented in this report; with generally accepted accounting (31) Rule 13a-14(a)/15d-14(a) 4. The small business issuer’s other principles; Certifications. The certifications certifying officer(s) and I are responsible (c) Evaluated the effectiveness of the required by Rule 13a-14(a) (17 CFR for establishing and maintaining small business issuer’s disclosure 240.13a-14(a)) or Rule 15d-14(a) (17 CFR disclosure controls and procedures (as controls and procedures and presented 240.15d-14(a)) exactly as set forth defined in Exchange Act Rules 13a– in this report our conclusions about the below: 15(e) and 15d–15(e)) and internal effectiveness of the disclosure controls control over financial reporting (as and procedures, as of the end of the Certifications * defined in Exchange Act Rules 13a–15(f) period covered by this report based on I, [identify the certifying individual], and 15d–15(f)) for the small business such evaluation; and certify that: issuer and have: (d) Disclosed in this report any 1. I have reviewed this [specify report] (a) Designed such disclosure controls change in the small business issuer’s of [identify small business issuer]; and procedures, or caused such internal control over financial reporting 2. Based on my knowledge, this report disclosure controls and procedures to be that occurred during the small business does not contain any untrue statement designed under our supervision, to issuer’s most recent fiscal quarter (the of a material fact or omit to state a ensure that material information relating small business issuer’s fourth fiscal material fact necessary to make the to the small business issuer, including quarter in the case of an annual report) statements made, in light of the its consolidated subsidiaries, is made that has materially affected, or is circumstances under which such known to us by others within those reasonably likely to materially affect, statements were made, not misleading entities, particularly during the period the small business issuer’s internal with respect to the period covered by in which this report is being prepared; control over financial reporting; and this report; (b) Designed such internal control 5. The small business issuer’s other 3. Based on my knowledge, the over financial reporting, or caused such certifying officer(s) and I have disclosed, financial statements, and other financial internal control over financial reporting based on our most recent evaluation of information included in this report, to be designed under our supervision, to internal control over financial reporting, fairly present in all material respects the provide reasonable assurance regarding to the small business issuer’s auditors financial condition, results of operations the reliability of financial reporting and and the audit committee of the small and cash flows of the small business the preparation of financial statements business issuer’s board of directors (or

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persons performing the equivalent ■ 10. By revising § 229.307 to read as assessment of the registrant’s internal functions): follows: control over financial reporting. (a) All significant deficiencies and (b) Attestation report of the registered material weaknesses in the design or § 229.307 (Item 307) Disclosure controls and procedures. public accounting firm. Provide the operation of internal control over registered public accounting firm’s financial reporting which are reasonably Disclose the conclusions of the registrant’s principal executive and attestation report on management’s likely to adversely affect the small assessment of the registrant’s internal business issuer’s ability to record, principal financial officers, or persons control over financial reporting in the process, summarize and report financial performing similar functions, regarding registrant’s annual report containing the information; and the effectiveness of the registrant’s disclosure required by this Item. (b) Any fraud, whether or not disclosure controls and procedures (as material, that involves management or defined in § 240.13a–15(e) or 240.15d– (c) Changes in internal control over other employees who have a significant 15(e) of this chapter) as of the end of the financial reporting. Disclose any change role in the small business issuer’s period covered by the report, based on in the registrant’s internal control over internal control over financial reporting. the evaluation of these controls and financial reporting identified in Date: procedures required by paragraph (b) of connection with the evaluation required lllllllllllllllllllll § 240.13a–15 or 240.15d–15 of this by paragraph (d) of § 240.13a–15 or llllllllllllllllllll chapter. 240.15d–15 of this chapter that occurred [Signature] ■ 11. By adding § 229.308 to read as during the registrant’s last fiscal quarter [Title] follows: (the registrant’s fourth fiscal quarter in * Provide a separate certification for each the case of an annual report) that has § 229.308 (Item 308) Internal control over principal executive officer and principal financial reporting. materially affected, or is reasonably financial officer of the small business issuer. likely to materially affect, the See Rules 13a–14(a) and 15d–14(a) (a) Management’s annual report on registrant’s internal control over internal control over financial reporting. financial reporting. (32) Section 1350 Certifications. Provide a report of management on the (i) The certifications required by Rule registrant’s internal control over Instructions to Item 308 13a–14(b) (17 CFR 240.13a–14(b)) or financial reporting (as defined in Rule 15d–14(b) (17 CFR 240.15d–14(b)) § 240.13a–15(f) or 240.15d–15(f) of this 1. The registrant must maintain and Section 1350 of Chapter 63 of Title chapter) that contains: evidential matter, including 18 of the United States Code (18 U.S.C. (1) A statement of management’s documentation, to provide reasonable 1350). responsibility for establishing and support for management’s assessment of (ii) A certification furnished pursuant maintaining adequate internal control the effectiveness of the registrant’s to this Item will not be deemed ‘‘filed’’ over financial reporting for the internal control over financial reporting. for purposes of section 18 of the registrant; 2. A registrant that is an Asset-Backed Exchange Act (15 U.S.C. 78r), or (2) A statement identifying the otherwise subject to the liability of that Issuer (as defined in § 240.13a–14(g) and framework used by management to § 240.15d–14(g) of this chapter) is not section. Such certification will not be evaluate the effectiveness of the deemed to be incorporated by reference required to disclose the information registrant’s internal control over required by this Item. into any filing under the Securities Act financial reporting as required by or the Exchange Act, except to the paragraph (c) of § 240.13a–15 or § 229.401 [Amended] extent that the small business issuer 240.15d–15 of this chapter; specifically incorporates it by reference. (3) Management’s assessment of the ■ 12. By amending § 229.401 by (33) through (98) [Reserved] effectiveness of the registrant’s internal removing the phrase ‘‘internal controls * * * * * control over financial reporting as of the and procedures for financial reporting’’ end of the registrant’s most recent fiscal in paragraph (h)(2)(iv) of Item 401 and PART 229—STANDARD year, including a statement as to adding, in its place, the phrase ‘‘internal INSTRUCTIONS FOR FILING FORMS whether or not internal control over control over financial reporting’’. UNDER SECURITIES ACT OF 1933, financial reporting is effective. This SECURITIES EXCHANGE ACT OF 1934 ■ 13. By amending § 229.601 by: discussion must include disclosure of AND ENERGY POLICY AND ■ any material weakness in the registrant’s a. Removing the second and third CONSERVATION ACT OF 1975— internal control over financial reporting sentences of paragraph (a)(1); REGULATION S–K identified by management. Management ■ b. Revising the Exhibit Table which ■ 9. The general authority citation for is not permitted to conclude that the follows the Instructions to the Exhibit Part 229 is revised to read as follows: registrant’s internal control over Table; and financial reporting is effective if there ■ c. Revising paragraphs (b)(27) through Authority: 15 U.S.C. 77e, 77f, 77g, 77h, 77j, are one or more material weaknesses in 77k, 77s, 77z–2, 77z–3, 77aa(25), 77aa(26), (b)(98). the registrant’s internal control over 77ddd, 77eee, 77ggg, 77hhh, 77iii, 77jjj, ■ The revisions read as follows: 77nnn, 77sss, 78c, 78i, 78j, 78l, 78m, 78n, financial reporting; and 78o, 78u–5, 78w, 78ll, 78mm, 79e, 79j, 79n, (4) A statement that the registered § 229.601 (Item 601) Exhibits. 79t, 80a–8, 80a–9, 80a–20, 80a–29, 80a–30, public accounting firm that audited the 80a–31(c), 80a–37, 80a–38(a), 80a–39, 80b– financial statements included in the (a) Exhibits and index required. *** 11, 7202, 7241, and 7262; and 18 U.S.C. annual report containing the disclosure Instructions to the Exhibit Table 1350, unless otherwise noted. required by this Item has issued an * * * * * attestation report on management’s * * * * *

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EXHIBIT TABLE

Securities act forms Exchange act forms S– 10– 10– 3 3 10 8–K S–1S–2S–3S–4 S–8 11 F–1F–2F–3F–4 Q K

(1) Underwriting agreement ...... X X X X ...... X X X X X ...... X ...... (2) Plan of acquisition, reorganization, arrangement, liquidation or succession ... X X X X ...... X X XXXXXXX (3) (i) Articles of incorporation ...... X ...... X ...... X X ...... X X ...... X X (ii) By-laws ...... X ...... X ...... X X ...... X X ...... X X (4) Instruments defining the rights of security holders, including indentures ...... XXXXXXXXXXXXXX (5) Opinion re legality ...... X X XXXXXXXX...... (6) [Reserved]...... N/A N/A N/A N/A N/A N/A N/A N/A N/A N/A N/A N/A N/A N/A (7) [Reserved]...... N/A N/A N/A N/A N/A N/A N/A N/A N/A N/A N/A N/A N/A N/A (8) Opinion re tax matters ...... XXXX...... X XXXX...... (9) Voting trust agreement ...... X X X XXXXXXXXXXX (10) Material contracts ...... X X ...... X ...... X X X ...... X X ...... X X (11) Statement re computation of per share earnings ...... X X ...... X ...... X X X ...... X X ...... X X (12) Statements re computation of ratios X X X X ...... X X X ...... X X ...... X (13) Annual report to security holders, Form 10–Q and 10–QSB, or quarterly report to security holders 1 ...... X ...... X ...... X (14) Code of Ethics ...... X (15) Letter re unaudited interim financial information ...... X X XXXXXXXX...... X ...... (16) Letter re change in certifying accountant 4 ...... X X ...... X ...... X ...... X X ...... X (17) Letter re director resignation ...... X ...... (18) Letter re change in accounting principles ...... X X (19) Report furnished to security holders ...... X ...... (20) Other documents or statements to security holders ...... X ...... (21) Subsidiaries of the registrant ...... X ...... X ...... X X ...... X X ...... X (22) Published report regarding matters submitted to vote of security holders ...... X X (23) Consents of experts and counsel ..... X X X X XXXXXX...... X 2 X2 X2 (24) Power of attorney ...... X X XXXXXXXXXXXX (25) Statement of eligibility of trustee ...... X X X X ...... XXXXX...... (26) Invitations for competitive bids ...... X X X X ...... X X X X ...... (27) through (30) [Reserved] ...... (31) Rule 13a–14(a)/15d–14(a) Certifi- cations ...... X X (32) Section 1350 Certifications ...... X X (33) through (98) [Reserved]...... N/A N/A N/A N/A N/A N/A N/A N/A N/A N/A N/A N/A N/A N/A (99) Additional exhibits ...... X XXXXXXXXXXXXX 1 Where incorporated by reference into the text of the prospectus and delivered to security holders along with the prospectus as permitted by the registration statement; or, in the case of the Form 10–K, where the annual report to security holders is incorporated by reference into the text of the Form 10–K. 2 Where the opinion of the expert or counsel has been incorporated by reference into a previously filed Securities Act registration statement. 3 An exhibit need not be provided about a company if: (1) With respect to such company an election has been made under Form S–4 or F–4 to provide information about such company at a level prescribed by Forms S–2, S–3, F–2 or F–3 and (2) the form, the level of which has been elected under Forms S–4 or F–4, would not require such company to provide such exhibit if it were registering a primary offering. 4 If required pursuant to Item 304 of Regulation S–K.

(b) Description of exhibits. *** 2. Based on my knowledge, this report and cash flows of the registrant as of, (27) through (30) [Reserved] does not contain any untrue statement and for, the periods presented in this (31) Rule 13a–14(a)/15d–14(a) of a material fact or omit to state a report; Certifications. The certifications material fact necessary to make the 4. The registrant’s other certifying required by Rule 13a–14(a) (17 CFR statements made, in light of the officer(s) and I are responsible for 240.13a–14(a)) or Rule 15d–14(a) (17 circumstances under which such establishing and maintaining disclosure CFR 240.15d–14(a)) exactly as set forth statements were made, not misleading controls and procedures (as defined in below: with respect to the period covered by Exchange Act Rules 13a–15(e) and 15d– this report; 15(e)) and internal control over financial Certifications* 3. Based on my knowledge, the reporting (as defined in Exchange Act I, [identify the certifying individual], financial statements, and other financial Rules 13a–15(f) and 15d–15(f)) for the certify that: information included in this report, registrant and have: 1. I have reviewed this [specify report] fairly present in all material respects the (a) Designed such disclosure controls of [identify registrant]; financial condition, results of operations and procedures, or caused such

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disclosure controls and procedures to be (i) The certifications required by Rule the form being amended will govern the designed under our supervision, to 13a–14(b) (17 CFR 240.13a–14(b)) or number of copies to be filed in ensure that material information relating Rule 15d–14(b) (17 CFR 240.15d–14(b)) connection with a paper format to the registrant, including its and Section 1350 of Chapter 63 of Title amendment. Electronic filers satisfy the consolidated subsidiaries, is made 18 of the United States Code (18 U.S.C. provisions dictating the number of known to us by others within those 1350). copies by filing one copy of the entities, particularly during the period (ii) A certification furnished pursuant amendment in electronic format. See in which this report is being prepared; to this item will not be deemed ‘‘filed’’ § 232.309 of this chapter (Rule 309 of (b) Designed such internal control for purposes of Section 18 of the Regulation S–T). over financial reporting, or caused such Exchange Act (15 U.S.C. 78r), or ■ 16. By amending § 240.13a–14 by: internal control over financial reporting otherwise subject to the liability of that ■ a. Revising paragraphs (a) and (b); to be designed under our supervision, to section. Such certification will not be ■ b. Removing paragraph (c); provide reasonable assurance regarding deemed to be incorporated by reference ■ c. Redesignating paragraphs (d), (e) the reliability of financial reporting and into any filing under the Securities Act and (f) as paragraphs (c), (d) and (e); the preparation of financial statements or the Exchange Act, except to the ■ d. Revising newly redesignated for external purposes in accordance extent that the registrant specifically paragraph (c), the introductory text of with generally accepted accounting incorporates it by reference. newly redesignated paragraph (d) and principles; (33) through (98) [Reserved] newly redesignated paragraph (e); and (c) Evaluated the effectiveness of the ■ e. Adding and reserving new registrant’s disclosure controls and PART 240—GENERAL RULES AND paragraph (f). procedures and presented in this report REGULATIONS, SECURITIES The revisions read as follows: EXCHANGE ACT OF 1934 our conclusions about the effectiveness § 240.13a–14 Certification of disclosure in of the disclosure controls and ■ 14. The general authority citation for annual and quarterly reports. procedures, as of the end of the period Part 240 is revised to read as follows: (a) Each report, including transition covered by this report based on such Authority: 15 U.S.C. 77c, 77d, 77g, 77j, reports, filed on Form 10–Q, Form 10– evaluation; and QSB, Form 10–K, Form 10–KSB, Form (d) Disclosed in this report any 77s, 77z–2, 77z–3, 77eee, 77ggg, 77nnn, 77sss, 77ttt, 78c, 78d, 78e, 78f, 78g, 78i, 78j, 20–F or Form 40–F (§§ 249.308a, change in the registrant’s internal 249.308b, 249.310, 249.310b, 249.220f control over financial reporting that 78j–1, 78k, 78k–1, 78l, 78m, 78n, 78o, 78p, 78q, 78s, 78u–5, 78w, 78x, 78ll, 78mm, 79q, or 249.240f of this chapter) under occurred during the registrant’s most 79t, 80a–20, 80a–23, 80a–29, 80a–37, 80b–3, section 13(a) of the Act (15 U.S.C. recent fiscal quarter (the registrant’s 80b–4, 80b–11, 7202, 7241, 7262, and 7263; 78m(a)), other than a report filed by an fourth fiscal quarter in the case of an and 18 U.S.C. 1350, unless otherwise noted. Asset-Backed Issuer (as defined in annual report) that has materially * * * * * paragraph (g) of this section), must affected, or is reasonably likely to ■ 15. By revising § 240.12b–15 to read as include certifications in the form materially affect, the registrant’s internal follows: specified in the applicable exhibit filing control over financial reporting; and requirements of such report and such 5. The registrant’s other certifying § 240.12b–15 Amendments. certifications must be filed as an exhibit officer(s) and I have disclosed, based on All amendments must be filed under to such report. Each principal executive our most recent evaluation of internal cover of the form amended, marked and principal financial officer of the control over financial reporting, to the with the letter ‘‘A’’ to designate the issuer, or persons performing similar registrant’s auditors and the audit document as an amendment, e.g., ‘‘10– functions, at the time of filing of the committee of the registrant’s board of K/A,’’ and in compliance with pertinent report must sign a certification. directors (or persons performing the requirements applicable to statements (b) Each periodic report containing equivalent functions): and reports. Amendments filed financial statements filed by an issuer (a) All significant deficiencies and pursuant to this section must set forth pursuant to section 13(a) of the Act (15 material weaknesses in the design or the complete text of each item as U.S.C. 78m(a)) must be accompanied by operation of internal control over amended. Amendments must be the certifications required by Section financial reporting which are reasonably numbered sequentially and be filed 1350 of Chapter 63 of Title 18 of the likely to adversely affect the registrant’s separately for each statement or report United States Code (18 U.S.C. 1350) and ability to record, process, summarize amended. Amendments to a statement such certifications must be furnished as and report financial information; and may be filed either before or after an exhibit to such report as specified in (b) Any fraud, whether or not registration becomes effective. the applicable exhibit requirements for material, that involves management or Amendments must be signed on behalf such report. Each principal executive other employees who have a significant of the registrant by a duly authorized and principal financial officer of the role in the registrant’s internal control representative of the registrant. An issuer (or equivalent thereof) must sign over financial reporting. amendment to any report required to a certification. This requirement may be Date: include the certifications as specified in satisfied by a single certification signed lllllllllllllllllllll § 240.13a–14(a) or § 240.15d–14(a) must by an issuer’s principal executive and llllllllllllllllllll include new certifications by each principal financial officers. lllllllllllllllllllll principal executive and principal (c) A person required to provide a [Signature] financial officer of the registrant, and an certification specified in paragraph (a) lllllllllllllllllllll amendment to any report required to be or (b) of this section may not have the [Title] accompanied by the certifications as certification signed on his or her behalf *Provide a separate certification for each specified in § 240.13a–14(b) or pursuant to a power of attorney or other principal executive officer and principal § 240.15d–14(b) must be accompanied form of confirming authority. financial officer of the registrant. See Rules by new certifications by each principal (d) Each annual report filed by an 13a–14(a) and 15d–14(a). executive and principal financial officer Asset-Backed Issuer (as defined in (32) Section 1350 Certifications. of the registrant. The requirements of paragraph (g) of this section) under

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section 13(a) of the Act (15 U.S.C. which management’s evaluation of the (2) Provide reasonable assurance that 78m(a)) must include a certification issuer’s internal control over financial transactions are recorded as necessary to addressing the following items: * * * reporting is based must be a suitable, permit preparation of financial (e) With respect to Asset-Backed recognized control framework that is statements in accordance with generally Issuers, the certification required by established by a body or group that has accepted accounting principles, and that paragraph (d) of this section must be followed due-process procedures, receipts and expenditures of the issuer signed by the trustee of the trust (if the including the broad distribution of the are being made only in accordance with trustee signs the annual report) or the framework for public comment. authorizations of management and senior officer in charge of securitization (d) The management of each such directors of the issuer; and of the depositor (if the depositor signs issuer, other than an investment (3) Provide reasonable assurance the annual report). Alternatively, the company registered under section 8 of regarding prevention or timely detection senior officer in charge of the servicing the Investment Company Act of 1940, of unauthorized acquisition, use or function of the master servicer (or entity must evaluate, with the participation of disposition of the issuer’s assets that performing the equivalent functions) the issuer’s principal executive and could have a material effect on the may sign the certification. principal financial officers, or persons financial statements. (f) [Reserved] performing similar functions, any ■ 18. Amending § 240.15d–14 by: * * * * * change in the issuer’s internal control ■ a. Revising paragraphs (a) and (b); ■ b. Removing paragraph (c); ■ 17. Section 240.13a–15 is revised to over financial reporting, that occurred ■ c. Redesignating paragraphs (d), (e) read as follows: during each of the issuer’s fiscal quarters, or fiscal year in the case of a and (f) as paragraphs (c), (d) and (e); § 240.13a–15 Controls and procedures. foreign private issuer, that has ■ d. Revising newly redesignated (a) Every issuer that has a class of materially affected, or is reasonably paragraph (c), the introductory text of securities registered pursuant to section likely to materially affect, the issuer’s newly redesignated paragraph (d) and 12 of the Act (15 U.S.C. 78l), other than internal control over financial reporting. newly redesignated paragraph (e); and ■ e. Adding and reserving new an Asset-Backed Issuer (as defined in (e) For purposes of this section, the paragraph (f). § 240.13a–14(g)), a small business term disclosure controls and procedures The revisions read as follows: investment company registered on Form means controls and other procedures of N–5 (§§ 239.24 and 274.5 of this an issuer that are designed to ensure § 240.15d–14 Certification of disclosure in chapter), or a unit investment trust as that information required to be annual and quarterly reports. defined by section 4(2) of the disclosed by the issuer in the reports (a) Each report, including transition Investment Company Act of 1940 (15 that it files or submits under the Act (15 reports, filed on Form 10–Q, Form 10– U.S.C. 80a–4(2)), must maintain U.S.C. 78a et seq.) is recorded, QSB, Form 10–K, Form 10–KSB, Form disclosure controls and procedures (as processed, summarized and reported, 20–F or Form 40–F (§§ 249.308a, defined in paragraph (e) of this section) within the time periods specified in the 249.308b, 249.310, 249.310b, 249.220f and internal control over financial Commission’s rules and forms. or 249.240f of this chapter) under reporting (as defined in paragraph (f) of Disclosure controls and procedures section 15(d) of the Act (15 U.S.C. this section). include, without limitation, controls 78o(d)), other than a report filed by an (b) Each such issuer’s management and procedures designed to ensure that Asset-Backed Issuer (as defined in must evaluate, with the participation of information required to be disclosed by paragraph (g) of this section), must the issuer’s principal executive and an issuer in the reports that it files or include certifications in the form principal financial officers, or persons submits under the Act is accumulated specified in the applicable exhibit filing performing similar functions, the and communicated to the issuer’s requirements of such report and such effectiveness of the issuer’s disclosure management, including its principal certifications must be filed as an exhibit controls and procedures, as of the end executive and principal financial to such report. Each principal executive of each fiscal quarter, except that officers, or persons performing similar and principal financial officer of the management must perform this functions, as appropriate to allow timely issuer, or persons performing similar evaluation: decisions regarding required disclosure. functions, at the time of filing of the (1) In the case of a foreign private (f) The term internal control over report must sign a certification. issuer (as defined in § 240.3b–4) as of financial reporting is defined as a (b) Each periodic report containing the end of each fiscal year; and process designed by, or under the financial statements filed by an issuer (2) In the case of an investment supervision of, the issuer’s principal pursuant to section 15(d) of the Act (15 company registered under section 8 of executive and principal financial U.S.C. 78o(d)) must be accompanied by the Investment Company Act of 1940 officers, or persons performing similar the certifications required by Section (15 U.S.C. 80a–8), within the 90-day functions, and effected by the issuer’s 1350 of Chapter 63 of Title 18 of the period prior to the filing date of each board of directors, management and United States Code (18 U.S.C. 1350) and report requiring certification under other personnel, to provide reasonable such certifications must be furnished as § 270.30a–2 of this chapter. assurance regarding the reliability of an exhibit to such report as specified in (c) The management of each such financial reporting and the preparation the applicable exhibit requirements for issuer, other than an investment of financial statements for external such report. Each principal executive company registered under section 8 of purposes in accordance with generally and principal financial officer of the the Investment Company Act of 1940, accepted accounting principles and issuer (or equivalent thereof) must sign must evaluate, with the participation of includes those policies and procedures a certification. This requirement may be the issuer’s principal executive and that: satisfied by a single certification signed principal financial officers, or persons (1) Pertain to the maintenance of by an issuer’s principal executive and performing similar functions, the records that in reasonable detail principal financial officers. effectiveness, as of the end of each fiscal accurately and fairly reflect the (c) A person required to provide a year, of the issuer’s internal control over transactions and dispositions of the certification specified in paragraph (a) financial reporting. The framework on assets of the issuer; or (b) of this section may not have the

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certification signed on his or her behalf principal financial officers, or persons (1) Pertain to the maintenance of pursuant to a power of attorney or other performing similar functions, the records that in reasonable detail form of confirming authority. effectiveness, as of the end of each fiscal accurately and fairly reflect the (d) Each annual report filed by an year, of the issuer’s internal control over transactions and dispositions of the Asset-Backed Issuer (as defined in financial reporting. The framework on assets of the issuer; paragraph (g) of this section) under which management’s evaluation of the (2) Provide reasonable assurance that section 15(d) of the Act (15 U.S.C. issuer’s internal control over financial transactions are recorded as necessary to 78o(d)), must include a certification reporting is based must be a suitable, permit preparation of financial addressing the following items: * * * recognized control framework that is statements in accordance with generally (e) With respect to Asset-Backed established by a body or group that has accepted accounting principles, and that Issuers, the certification required by followed due-process procedures, receipts and expenditures of the issuer paragraph (d) of this section must be including the broad distribution of the are being made only in accordance with signed by the trustee of the trust (if the framework for public comment. authorizations of management and trustee signs the annual report) or the (d) The management of each such directors of the issuer; and senior officer in charge of securitization issuer, other than an investment (3) Provide reasonable assurance of the depositor (if the depositor signs company registered under section 8 of regarding prevention or timely detection the annual report). Alternatively, the the Investment Company Act of 1940, of unauthorized acquisition, use or senior officer in charge of the servicing must evaluate, with the participation of disposition of the issuer’s assets that function of the master servicer (or entity the issuer’s principal executive and could have a material effect on the performing the equivalent functions) principal financial officers, or persons financial statements. may sign the certification. performing similar functions, any PART 249—FORMS, SECURITIES (f) [Reserved] change in the issuer’s internal control EXCHANGE ACT OF 1934 * * * * * over financial reporting, that occurred ■ 19. Section 240.15d–15 is revised to during each of the issuer’s fiscal ■ 20. The general authority citation for read as follows: quarters, or fiscal year in the case of a Part 249 and the subauthority citation for foreign private issuer, that has ‘‘Section 249.331’’ are revised to read as § 240.15d–15 Controls and procedures. materially affected, or is reasonably follows: (a) Every issuer that files reports likely to materially affect, the issuer’s Authority: 15 U.S.C. 78a et seq., 7202, under section 15(d) of the Act (15 U.S.C. internal control over financial reporting. 7233, 7241, 7262, 7264, and 7265; and 18 78o(d)), other than an Asset-Backed (e) For purposes of this section, the U.S.C. 1350, unless otherwise noted. Issuer (as defined in § 240.15d–14(g) of term disclosure controls and procedures * * * * * this chapter), a small business means controls and other procedures of Section 249.331 is also issued under investment company registered on Form an issuer that are designed to ensure 15 U.S.C. 78j-1, 7202, 7233, 7241, 7264, N–5 (§§ 239.24 and 274.5 of this that information required to be 7265; and 18 U.S.C. 1350. chapter), or a unit investment trust as disclosed by the issuer in the reports * * * * * defined in section 4(2) of the Investment that it files or submits under the Act (15 ■ 21. By amending Form 10-Q Company Act of 1940 (15 U.S.C. 80a– U.S.C. 78a et seq.) is recorded, (referenced in § 249.308a) by: 4(2)), must maintain disclosure controls processed, summarized and reported, ■ a. Removing the last sentence of and procedures (as defined in paragraph within the time periods specified in the General Instruction G; (e) of this section) and internal control Commission’s rules and forms. ■ b. Revising Item 4 to ‘‘Part I—Financial over financial reporting (as defined in Disclosure controls and procedures Information;’’ and paragraph (f) of this section). include, without limitation, controls ■ c. Removing the ‘‘Certifications’’ (b) Each such issuer’s management and procedures designed to ensure that section after the ‘‘Signatures’’ section. must evaluate, with the participation of information required to be disclosed by ■ The revision reads as follows. the issuer’s principal executive and an issuer in the reports that it files or Note: The text of Form 10–Q does not, and principal financial officers, or persons submits under the Act is accumulated this amendment will not, appear in the Code performing similar functions, the and communicated to the issuer’s of Federal Regulations. effectiveness of the issuer’s disclosure management, including its principal controls and procedures, as of the end executive and principal financial Form 10–Q of each fiscal quarter, except that officers, or persons performing similar * * * * * management must perform this functions, as appropriate to allow timely evaluation: decisions regarding required disclosure. Part I—Financial Information (1) In the case of a foreign private (f) The term internal control over * * * * * issuer (as defined in § 240.3b–4) as of financial reporting is defined as a the end of each fiscal year; and process designed by, or under the Item 4. Controls and Procedures. (2) In the case of an investment supervision of, the issuer’s principal Furnish the information required by company registered under section 8 of executive and principal financial Items 307 of Regulation S-K (17 CFR the Investment Company Act of 1940 officers, or persons performing similar 229.307) and 308(c) of Regulation S-K (15 U.S.C. 80a–8), within the 90-day functions, and effected by the issuer’s (17 CFR 229.308(c)). period prior to the filing date of each board of directors, management and * * * * * report requiring certification under other personnel, to provide reasonable ■ 22. By amending Form 10-QSB § 270.30a–2 of this chapter. assurance regarding the reliability of (referenced in § 249.308b) by: (c) The management of each such financial reporting and the preparation ■ a. Removing the last sentence of issuer, other than an investment of financial statements for external paragraph 2 of General Instruction F; company registered under section 8 of purposes in accordance with generally ■ b. Revising Item 3 to ‘‘Part I—Financial the Investment Company Act of 1940, accepted accounting principles and Information;’’ and must evaluate, with the participation of includes those policies and procedures ■ c. Removing the ‘‘Certifications’’ the issuer’s principal executive and that: section after the ‘‘Signatures’’ section.

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■ The revision reads as follows. Form 10-K may wish to file, which shall be so Note: The text of Form 10-QSB does not, * * * * * marked as to indicate clearly the subject and this amendment will not, appear in the matters to which they refer. Code of Federal Regulations. Part II (13) Form F-X—Canadian issuers shall * * * * * file a written irrevocable consent and Form 10–QSB power of attorney on Form F-X. Item 9A. Controls and procedures. * * * * * (31) The exhibit described in Furnish the information required by paragraph (b)(31) of Item 601 of Part I—Financial Information Items 307 and 308 of Regulation S-K (17 Regulation S-B. * * * * * CFR 229.307 and 229.308). (32) The exhibit described in ■ 24. By amending Form 10-KSB paragraph (b)(32) of Item 601 of Item 3. Controls and Procedures. (referenced in § 249.310b) by: Regulation S-B. Furnish the information required by ■ a. Removing the phrase ‘‘(who also ■ 25. By amending Form 20–F Items 307 of Regulation S–B (17 CFR must provide the certification required (referenced in § 249.220f) by: 228.307) and 308(c) of Regulation S–B by Rule 13a-14 (17 CFR 240.13a-14) or ■ a. Revising paragraph (e) to General (17 CFR 228.308(c)). Rule 15d-14 (17 CFR 240.15d-14) exactly Instruction B; * * * * * as specified in this form)’’ each time it ■ b. Revising Item 15 of Part II; ■ 23. By amending Form 10–K appears in the first sentence of paragraph ■ c. Removing the phrase ‘‘internal (referenced in § 249.310) by: 2 of General Instruction C.; controls and procedures for financial ■ a. Removing the phrase ‘‘(who also ■ b. Redesignating Item 14 of Part III as reporting’’ in paragraph (b)(4) of Item must provide the certification required Item 8A of Part II and revising newly 16A of Part II and adding, in its place, by Rule 13a–14 (17 CFR 240.13a–14) or redesignated Item 8A; the phrase ‘‘internal control over Rule 15d–14 (17 CFR 240.15d–14) ■ c. Redesignating Item 15 of Part III as financial reporting’’; exactly as specified in this form)’’ each Item 14; ■ d. Removing the ‘‘Certifications’’ ■ time it appears in the first sentence of d. ‘‘Instruction to Item 15’’ is corrected section after the ‘‘Signatures’’ section paragraph (2)(a) of General Instruction to read ‘‘Instruction to Item 14’’; ■ and before the section referencing D.; e. Revising Item 2 of Part III of ‘‘Instructions as to Exhibits’’; and ■ b. Removing the phrase ‘‘(Items 1 ‘‘INFORMATION REQUIRED IN ■ e. In the ‘‘Instruction as to Exhibits’’ through 9 or any portion thereof)’’ and ANNUAL REPORT OF TRANSITIONAL section, redesignate paragraph 12 as adding, in its place, the phrase ‘‘(Items SMALL BUSINESS ISSER’’; and paragraph 14 and add new paragraph 12 ■ f. Removing the ‘‘Certifications’’ 1 through 9A or any portion thereof)’’ in and paragraph 13. section after the ‘‘Signatures’’ section the first sentence of paragraph (2) of ■ The revisions and addition read as and before the reference to General Instruction G.; follows. ■ c. Removing the phrase ‘‘(Items 10, 11, ‘‘Supplemental Information to be Note: The text of Form 20–F does not, and 12 and 13)’’ and adding, in its place, the Furnished With Reports Filed Pursuant to Section 15(d) of the Exchange Act By this amendment will not, appear in the Code phrase ‘‘(Items 10, 11, 12, 13 and 14)’’ in of Federal Regulations. the first sentence of paragraph (3) of Non-reporting Issuers.’’ General Instruction G.; Note: The text of Form 10-KSB does not, Form 20–F ■ d. Removing the phrase ‘‘(Items 1 and this amendment will not, appear in the through 9)’’ in the third sentence of Code of Federal Regulations. * * * * * paragraph (4) of General Instruction G General Instructions and adding, in its place, the phrase Form 10–KSB * * * * * ‘‘(Items 1 through 9A)’’; * * * * * ■ e. Removing the phrase ‘‘(Items 10 B. General Rules and Regulations That PART II through 13)’’ in the third sentence of Apply to this Form. paragraph (4) of General Instruction G * * * * * and adding, in its place, the phrase * * * * * ‘‘(Items 10 through 14)’’; Item 8A. Controls and Procedures (e) Where the Form is being used as ■ f. Redesignating Item 14 of Part III as Furnish the information required by an annual report filed under Section Item 9A of Part II and revising newly Items 307 of Regulation S-B (17 CFR 13(a) or 15(d) of the Exchange Act, redesignated Item 9A; 228.307) and 308 of Regulation S-B (17 provide the certifications required by ■ g. Redesignating Item 15 in Part III as CFR 228.308). Rule 13a-14 (17 CFR 240.13a-14) or Rule 15d-14 (17 CFR 240.15d-14). Item 14; * * * * * ■ h. ‘‘Instruction to Item 15’’ is corrected * * * * * to read ‘‘Instruction to Item 14’’; Information Required in Annual Report ■ i. Redesignating Item 16 in Part IV as of Transitional Small Business isser Part II Item 15; * * * * * * * * * * ■ j. Removing the ‘‘Certifications’’ section after the ‘‘Signatures’’ section PART III Item 15. Controls and Procedures. and before the reference to * * * * * (a) Disclosure Controls and ‘‘Supplemental Information to be Procedures. Where the Form is being Furnished With Reports Filed Pursuant Item 2. Description of Exhibits. used as an annual report filed under to Section 15(d) of the Act by Issuers As appropriate, the issuer should file Section 13(a) or 15(d) of the Exchange Which Have Not Registered Securities those documents required to be filed as Act, disclose the conclusions of the Pursuant to Section 12 of the Act.’’ Exhibit Number 2, 3, 5, 6, and 7 in Part issuer’s principal executive and ■ The revision reads as follows. III of Form 1-A. The registrant also shall principal financial officers, or persons Note: The text of Form 10-K does not, and file: performing similar functions, regarding this amendment will not, appear in the Code (12) Additional exhibits—Any the effectiveness of the issuer’s of Federal Regulations. additional exhibits which the issuer disclosure controls and procedures (as

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defined in 17 CFR 240.13a-15(e) or has materially affected, or is reasonably to be designed under our supervision, to 240.15d-15(e)) as of the end of the likely to materially affect, the issuer’s provide reasonable assurance regarding period covered by the report, based on internal control over financial reporting. the reliability of financial reporting and the evaluation of these controls and the preparation of financial statements Instructions to Item 15. procedures required by paragraph (b) of for external purposes in accordance 17 CFR 240.13a-15 or 240.15d-15. 1. The issuer must maintain with generally accepted accounting (b) Management’s annual report on evidential matter, including principles; internal control over financial reporting. documentation, to provide reasonable (c) Evaluated the effectiveness of the Where the Form is being used as an support for management’s assessment of company’s disclosure controls and annual report filed under Section 13(a) the effectiveness of the issuer’s internal procedures and presented in this report or 15(d) of the Exchange Act, provide a control over financial reporting. our conclusions about the effectiveness report of management on the issuer’s 2. An issuer that is an Asset-Backed of the disclosure controls and internal control over financial reporting Issuer (as defined in 17 CFR 240.13a– procedures, as of the end of the period (as defined in 17 CFR 240.13a–15(f) or 14(g) and 17 CFR 240.15d–14(g)) is not covered by this report based on such 240.15d–15(f)) that contains: required to disclose the information evaluation; and (1) A statement of management’s required by this Item. (d) Disclosed in this report any responsibility for establishing and * * * * * change in the company’s internal maintaining adequate internal control control over financial reporting that over financial reporting for the issuer; Instructions as to Exhibits occurred during the period covered by (2) A statement identifying the * * * * * the annual report that has materially framework used by management to 12. The certifications required by Rule affected, or is reasonably likely to evaluate the effectiveness of the issuer’s 13a–14(a) (17 CFR 240.13a–14(a)) or materially affect, the company’s internal internal control over financial reporting Rule 15d–14(a) (17 CFR 240.15d–14(a)) control over financial reporting; and as required by paragraph (c) of 17 CFR exactly as set forth below: 5. The company’s other certifying 240.13a–15 or 240.15d–15; officer(s) and I have disclosed, based on Certifications* (3) Management’s assessment of the our most recent evaluation of internal effectiveness of the issuer’s internal I, [identify the certifying individual], control over financial reporting, to the control over financial reporting as of the certify that: company’s auditors and the audit end of the issuer’s most recent fiscal 1. I have reviewed this annual report committee of the company’s board of year, including a statement as to on Form 20–F of [identify company]; directors (or persons performing the whether or not internal control over 2. Based on my knowledge, this report equivalent functions): financial reporting is effective. This does not contain any untrue statement (a) All significant deficiencies and discussion must include disclosure of of a material fact or omit to state a material weaknesses in the design or any material weakness in the issuer’s material fact necessary to make the operation of internal control over internal control over financial reporting statements made, in light of the financial reporting which are reasonably identified by management. Management circumstances under which such likely to adversely affect the company’s is not permitted to conclude that the statements were made, not misleading ability to record, process, summarize issuer’s internal control over financial with respect to the period covered by and report financial information; and reporting is effective if there are one or this report; (b) Any fraud, whether or not more material weaknesses in the issuer’s 3. Based on my knowledge, the material, that involves management or internal control over financial reporting; financial statements, and other financial other employees who have a significant and information included in this report, role in the company’s internal control (4) A statement that the registered fairly present in all material respects the over financial reporting. public accounting firm that audited the financial condition, results of operations Date: financial statements included in the and cash flows of the company as of, lllllllllllllllllllll annual report containing the disclosure and for, the periods presented in this lllllllllllllllllllll required by this Item has issued an report; lllllllllllllllllllll attestation report on management’s 4. The company’s other certifying [Signature] assessment of the issuer’s internal officer(s) and I are responsible for lllllllllllllllllllll control over financial reporting. establishing and maintaining disclosure [Title] (c) Attestation report of the registered controls and procedures (as defined in *Provide a separate certification for each public accounting firm. Where the Form Exchange Act Rules 13a–15(e) and 15d– principal executive officer and principal is being used as an annual report filed 15(e)) and internal control over financial financial officer of the company. See Rules under Section 13(a) or 15(d) of the reporting (as defined in Exchange Act 13a–14(a) and 15d–14(a). Exchange Act, provide the registered Rules 13a–15(f) and 15d–15(f)) for the 13. (a) The certifications required by public accounting firm’s attestation company and have: Rule 13a–14(b) (17 CFR 240.13a–14(b)) report on management’s assessment of (a) Designed such disclosure controls or Rule 15d–14(b) (17 CFR 240.15d– the issuer’s internal control over and procedures, or caused such 14(b)) and Section 1350 of Chapter 63 of financial reporting in the issuer’s annual disclosure controls and procedures to be Title 18 of the United States Code (18 report containing the disclosure designed under our supervision, to U.S.C. 1350). required by this Item. ensure that material information relating (b) A certification furnished pursuant (d) Changes in internal control over to the company, including its to Rule 13a–14(b) (17 CFR 240.13a– financial reporting. Disclose any change consolidated subsidiaries, is made 14(b)) or Rule 15d–14(b) (17 CFR in the issuer’s internal control over known to us by others within those 240.15d–14(b)) and Section 1350 of financial reporting identified in entities, particularly during the period Chapter 63 of Title 18 of the United connection with the evaluation required in which this report is being prepared; States Code (18 U.S.C. 1350) will not be by paragraph (d) of 17 CFR 240.13a–15 (b) Designed such internal control deemed ‘‘filed’’ for purposes of Section or 240.15d–15 that occurred during the over financial reporting, or caused such 18 of the Exchange Act [15 U.S.C. 78r], period covered by the annual report that internal control over financial reporting or otherwise subject to the liability of

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that section. Such certification will not Rules 13a–15(f) and 15d–15(f)) for the (2) (i) Provide the certifications be deemed to be incorporated by issuer and have: required by Rule 13a–14(b) (17 CFR reference into any filing under the (a) Designed such disclosure controls 240.13a–14(b)) or Rule 15d–14(b) (17 Securities Act or the Exchange Act, and procedures, or caused such CFR 240.15d–14(b)) and Section 1350 of except to the extent that the company disclosure controls and procedures to be Chapter 63 of Title 18 of the United specifically incorporates it by reference. designed under our supervision, to States Code (18 U.S.C. 1350) as an ■ 26. By amending Form 40–F ensure that material information relating exhibit to this report. (referenced in § 249.240f) by: to the issuer, including its consolidated (ii) A certification furnished pursuant ■ a. Revising paragraph (6) to General subsidiaries, is made known to us by to Rule 13a–14(b) (17 CFR 240.13a– Instruction B; and others within those entities, particularly 14(b)) or Rule 15d–14(b) (17 CFR ■ b. Removing the phrase ‘‘internal during the period in which this report 240.15d–14(b)) and Section 1350 of controls and procedures for financial is being prepared; Chapter 63 of Title 18 of the United reporting’’ and adding, in its place, the (b) Designed such internal control States Code (18 U.S.C. 1350) will not be phrase ‘‘internal control over financial over financial reporting, or caused such deemed ‘‘filed’’ for purposes of Section internal control over financial reporting reporting’’ in paragraph (8)(b)(4) of 18 of the Exchange Act [15 U.S.C. 78r], to be designed under our supervision, to General Instruction B; and or otherwise subject to the liability of ■ c. Removing the ‘‘Certifications’’ provide reasonable assurance regarding that section. Such certification will not section after the ‘‘Signatures’’ section. the reliability of financial reporting and be deemed to be incorporated by ■ The revision reads as follows. the preparation of financial statements reference into any filing under the for external purposes in accordance Securities Act or the Exchange Act, Note: The text of Form 40–F does not, and with generally accepted accounting except to the extent that the issuer this amendment will not, appear in the Code principles; specifically incorporates it by reference. of Federal Regulations. (c) Evaluated the effectiveness of the (b) Disclosure Controls and issuer’s disclosure controls and Procedures. Where the Form is being FORM 40–F procedures and presented in this report used as an annual report filed under * * * * * our conclusions about the effectiveness Section 13(a) or 15(d) of the Exchange Act, disclose the conclusions of the General Instructions of the disclosure controls and procedures, as of the end of the period issuer’s principal executive and * * * * * covered by this report based on such principal financial officers, or persons B. Information To Be Filed on this Form evaluation; and performing similar functions, regarding (d) Disclosed in this report any the effectiveness of the issuer’s * * * * * change in the issuer’s internal control disclosure controls and procedures (as (6) Where the Form is being used as over financial reporting that occurred defined in 17 CFR 240.13a-15(e) or an annual report filed under Section during the period covered by the annual 240.15d-15(e)) as of the end of the 13(a) or 15(d) of the Exchange Act: report that has materially affected, or is period covered by the report, based on (a) (1) Provide the certifications reasonably likely to materially affect, the evaluation of these controls and required by Rule 13a–14(a) (17 CFR the issuer’s internal control over procedures required by paragraph (b) of 240.13a–14(a)) or Rule 15d–14(a) (17 financial reporting; and 17 CFR 240.13a-15 or 240.15d-15. CFR 240.15d–14(a)) as an exhibit to this 5. The issuer’s other certifying (c) Management’s annual report on report exactly as set forth below. officer(s) and I have disclosed, based on internal control over financial reporting. Certifications* our most recent evaluation of internal Where the Form is being used as an control over financial reporting, to the annual report filed under Section 13(a) I, [identify the certifying individual], issuer’s auditors and the audit or 15(d) of the Exchange Act, provide a certify that: committee of the issuer’s board of report of management on the issuer’s 1. I have reviewed this annual report directors (or persons performing the internal control over financial reporting on Form 40–F of [identify issuer]; equivalent functions): (as defined in 17 CFR 240.13a-15(f) or 2. Based on my knowledge, this report (a) All significant deficiencies and 240.15d-15(f)) that contains: does not contain any untrue statement material weaknesses in the design or (1) A statement of management’s of a material fact or omit to state a operation of internal control over responsibility for establishing and material fact necessary to make the financial reporting which are reasonably maintaining adequate internal control statements made, in light of the likely to adversely affect the issuer’s over financial reporting for the issuer; circumstances under which such ability to record, process, summarize (2) A statement identifying the statements were made, not misleading and report financial information; and framework used by management to with respect to the period covered by (b) Any fraud, whether or not evaluate the effectiveness of the issuer’s this report; material, that involves management or internal control over financial reporting 3. Based on my knowledge, the other employees who have a significant as required by paragraph (c) of 17 CFR financial statements, and other financial role in the issuer’s internal control over 240.13a-15 or 240.15d-15; information included in this report, financial reporting. (3) Management’s assessment of the fairly present in all material respects the Date: effectiveness of the issuer’s internal financial condition, results of operations lllllllllllllllllllll control over financial reporting as of the and cash flows of the issuer as of, and lllllllllllllllllllll end of the issuer’s most recent fiscal for, the periods presented in this report; lllllllllllllllllllll year, including a statement as to 4. The issuer’s other certifying [Signature] whether or not internal control over officer(s) and I are responsible for lllllllllllllllllllll financial reporting is effective. This establishing and maintaining disclosure [Title] discussion must include disclosure of controls and procedures (as defined in *Provide a separate certification for each any material weakness in the issuer’s Exchange Act Rules 13a–15(e) and 15d– principal executive officer and principal internal control over financial reporting 15(e)) and internal control over financial financial officer of the issuer. See Rules 13a– identified by management. Management reporting (as defined in Exchange Act 14(a) and 15d–14(a). is not permitted to conclude that the

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issuer’s internal control over financial § 270.8b-15 Amendments. (as defined in paragraph (d) of this reporting is effective if there are one or * * * An amendment to any report section). more material weaknesses in the issuer’s required to include the certifications as (b) Each such registered management internal control over financial reporting; specified in § 270.30a-2(a) must include investment company’s management and new certifications by each principal must evaluate, with the participation of (4) A statement that the registered executive and principal financial officer the company’s principal executive and public accounting firm that audited the of the registrant, and an amendment to principal financial officers, or persons financial statements included in the any report required to be accompanied performing similar functions, the annual report containing the disclosure by the certifications as specified in effectiveness of the company’s required by this Item has issued an § 240.13a-14(b) or § 240.15d-14(b) and disclosure controls and procedures, attestation report on management’s § 270.30a-2(b) must be accompanied by within the 90-day period prior to the assessment of the issuer’s internal new certifications by each principal filing date of each report on Form N– control over financial reporting. executive and principal financial officer CSR (§§ 249.331 and 274.128 of this (d) Attestation report of the registered of the registrant. chapter). public accounting firm. Where the Form ■ 29. Section 270.30a-2 is revised to read (c) For purposes of this section, the is being used as an annual report filed as follows: term disclosure controls and procedures under Section 13(a) or 15(d) of the means controls and other procedures of Exchange Act, provide the registered § 270.30a-2 Certification of Form N–CSR. a registered management investment public accounting firm’s attestation (a) Each report filed on Form N-CSR company that are designed to ensure report on management’s assessment of (§§ 249.331 and 274.128 of this chapter) that information required to be internal control over financial reporting by a registered management investment disclosed by the investment company in the annual report containing the company must include certifications in on Form N–CSR (§§ 249.331 and disclosure required by this Item. the form specified in Item 10(a)(2) of 274.128 of this chapter) is recorded, (e) Changes in internal control over Form N–CSR and such certifications processed, summarized, and reported financial reporting. Disclose any change must be filed as an exhibit to such within the time periods specified in the in the issuer’s internal control over report. Each principal executive and Commission’s rules and forms. financial reporting identified in principal financial officer of the Disclosure controls and procedures connection with the evaluation required investment company, or persons include, without limitation, controls by paragraph (d) of 17 CFR 240.13a-15 performing similar functions, at the time and procedures designed to ensure that or 240.15d-15 that occurred during the of filing of the report must sign a information required to be disclosed by period covered by the annual report that certification. an investment company in the reports has materially affected, or is reasonably (b) Each report on Form N–CSR filed that it files or submits on Form N–CSR likely to materially affect, the issuer’s by a registered management investment is accumulated and communicated to internal control over financial reporting. company under Section 13(a) or 15(d) of the investment company’s management, Instructions to paragraphs (b), (c), (d) the Securities Exchange Act of 1934 (15 including its principal executive and and (e) of General Instruction B. 6. U.S.C. 78m(a) or 78o(d)) and that principal financial officers, or persons 1. The issuer must maintain contains financial statements must be performing similar functions, as evidential matter, including accompanied by the certifications appropriate to allow timely decisions documentation, to provide reasonable required by Section 1350 of Chapter 63 regarding required disclosure. support for management’s assessment of of Title 18 of the United States Code (18 (d) The term internal control over the effectiveness of the issuer’s internal U.S.C. 1350) and such certifications financial reporting is defined as a control over financial reporting. must be furnished as an exhibit to such process designed by, or under the 2. An issuer that is an Asset-Backed report as specified in Item 10(b) of Form supervision of, the registered Issuer (as defined in 17 CFR 240.13a- N–CSR. Each principal executive and management investment company’s 14(g) and 240.15d-14(g)) is not required principal financial officer of the principal executive and principal to disclose the information required by investment company (or equivalent financial officers, or persons performing this Item. thereof) must sign a certification. This similar functions, and effected by the requirement may be satisfied by a single company’s board of directors, * * * * * certification signed by an investment management, and other personnel, to PART 270—RULES AND company’s principal executive and provide reasonable assurance regarding REGULATIONS, INVESTMENT principal financial officers. the reliability of financial reporting and COMPANY ACT OF 1940 (c) A person required to provide a the preparation of financial statements certification specified in paragraph (a) for external purposes in accordance ■ 27. The authority citation for Part 270 or (b) of this section may not have the with generally accepted accounting is amended by revising the subauthority certification signed on his or her behalf principles and includes those policies citation for ‘‘Section 270.30a-2’’ to read pursuant to a power of attorney or other and procedures that: as follows: form of confirming authority. (1) Pertain to the maintenance of ■ 30. By revising § 270.30a-3 to read as records that in reasonable detail Authority: 15 U.S.C. 80a-1 et seq., 80a- accurately and fairly reflect the 34(d), 80a-37, and 80a-39, unless otherwise follows: noted. transactions and dispositions of the § 270.30a-3 Controls and procedures. assets of the investment company; * * * * * (a) Every registered management (2) Provide reasonable assurance that Section 270.30a-2 is also issued under investment company, other than a small transactions are recorded as necessary to 15 U.S.C. 78m, 78o(d), 80a-8, 80a-29, business investment company registered permit preparation of financial 7202, and 7241; and 18 U.S.C. 1350, on Form N–5 (§§ 239.24 and 274.5 of statements in accordance with generally unless otherwise noted. this chapter), must maintain disclosure accepted accounting principles, and that * * * * * controls and procedures (as defined in receipts and expenditures of the ■ 28. By revising the last sentence of paragraph (c) of this section) and investment company are being made § 270.8b-15 to read as follows: internal control over financial reporting only in accordance with authorizations

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of management and directors of the General Instructions information included in this report, investment company; and * * * * * fairly present in all material respects the (3) Provide reasonable assurance financial condition, results of regarding prevention or timely detection F. Signature and Filing of Report. operations, changes in net assets, and of unauthorized acquisition, use, or * * * * * cash flows (if the financial statements disposition of the investment company’s 2. (a) The report must be signed by the are required to include a statement of assets that could have a material effect registrant, and on behalf of the registrant cash flows) of the registrant as of, and on the financial statements. by its principal executive and principal for, the periods presented in this report; financial officers. 4. The registrant’s other certifying PART 274—FORMS PRESCRIBED officer(s) and I are responsible for * * * * * UNDER THE INVESTMENT COMPANY establishing and maintaining disclosure ACT OF 1940 Item 9. Controls and Procedures. controls and procedures (as defined in (a) Disclose the conclusions of the Rule 30a-3(c) under the Investment ■ 31. The authority citation for Part 274 registrant’s principal executive and Company Act of 1940) and internal is amended by revising the authority principal financial officers, or persons control over financial reporting (as citation for ‘‘Section 274.128’’ to read as performing similar functions, regarding defined in Rule 30a-3(d) under the follows: the effectiveness of the registrant’s Investment Company Act of 1940) for Authority: 15 U.S.C. 77f, 77g, 77h, 77j, 77s, disclosure controls and procedures (as the registrant and have: 78c(b), 78l, 78m, 78n, 78o(d), 80a-8, 80a-24, defined in Rule 30a-3(c) under the Act (a) Designed such disclosure controls 80a-26, and 80a-29, unless otherwise noted. (17 CFR 270.30a-3(c))) as of a date and procedures, or caused such * * * * * within 90 days of the filing date of the disclosure controls and procedures to be Section 274.128 is also issued under report that includes the disclosure designed under our supervision, to 15 U.S.C. 78j-1, 7202, 7233, 7241, 7264, required by this paragraph, based on the ensure that material information relating and 7265; and 18 U.S.C. 1350. evaluation of these controls and to the registrant, including its ■ 32. Form N–SAR (referenced in procedures required by Rule 30a-3(b) consolidated subsidiaries, is made §§ 249.330 and 274.101) is amended by under the Act (17 CFR 270.30a-3(b)) and known to us by others within those revising the reference ‘‘internal controls Rules 13a-15(b) or 15d-15(b) under the entities, particularly during the period and procedures for financial reporting’’ Exchange Act (17 CFR 240.13a-15(b) or in which this report is being prepared; (b) Designed such internal control in paragraph (b)(6)(iv) of the Instruction 240.15d-15(b)). over financial reporting, or caused such to Sub-Item 102P3 to read ‘‘internal (b) Disclose any change in the internal control over financial reporting control over financial reporting’’. registrant’s internal control over to be designed under our supervision, to ■ 33. Form N–CSR (referenced in financial reporting (as defined in Rule provide reasonable assurance regarding §§ 249.331 and 274.128) is amended by: 30a-3(d) under the Act (17 CFR 270.30a- the reliability of financial reporting and ■ a. In General Instruction D, revising the 3(d)) that occurred during the the preparation of financial statements reference ‘‘Items 4, 5, and 10(a)’’ to read registrant’s last fiscal half-year (the for external purposes in accordance ‘‘Items 4, 5, and 10(a)(1)’’; registrant’s second fiscal half-year in the ■ b. Revising paragraph 2.(a) of General case of an annual report) that has with generally accepted accounting Instruction F; materially affected, or is reasonably principles; (c) Evaluated the effectiveness of the ■ c. In paragraph (c) of Item 2, revising likely to materially affect, the registrant’s disclosure controls and the reference ‘‘Item 10(a)’’ to read ‘‘Item registrant’s internal control over procedures and presented in this report 10(a)(1)’’; financial reporting. our conclusions about the effectiveness ■ d. In paragraph (f)(1) of Item 2, revising Item 10. Exhibits. of the disclosure controls and the reference ‘‘Item 10(a)’’ to read ‘‘Item procedures, as of a date within 90 days 10(a)(1)’’; (a) File the exhibits listed below as prior to the filing date of this report ■ e. In paragraph (b)(4) of Item 3, revising part of this Form. based on such evaluation; and the reference ‘‘internal controls and * * * * * (d) Disclosed in this report any procedures for financial reporting’’ to (a)(2) A separate certification for each change in the registrant’s internal read ‘‘internal control over financial principal executive and principal control over financial reporting that reporting’’; financial officer of the registrant as occurred during the registrant’s most ■ f. Revising Item 9; and required by Rule 30a-2(a) under the Act recent fiscal half-year (the registrant’s ■ g. In Item 10: (17 CFR 270.30a-2(a)), exactly as set second fiscal half-year in the case of an ■ (i) The introductory text and forth below: annual report) that has materially paragraphs (a) and (b) are redesignated as Certifications affected, or is reasonably likely to paragraphs (a), (a)(1) and (a)(2), materially affect, the registrant’s internal respectively; I, [identify the certifying individual], control over financial reporting; and ■ (ii) Revising newly redesignated certify that: 1. I have reviewed this report on Form 5. The registrant’s other certifying paragraph (a) and newly redesignated N-CSR of [identify registrant]; officer(s) and I have disclosed to the paragraph (a)(2); and 2. Based on my knowledge, this report registrant’s auditors and the audit ■ (iii) Adding new paragraph (b) and an does not contain any untrue statement committee of the registrant’s board of Instruction to Item 10. of a material fact or omit to state a directors (or persons performing the The revisions and additions read as material fact necessary to make the equivalent functions): follows. statements made, in light of the (a) All significant deficiencies and Note: The text of Form N-CSR does not, circumstances under which such material weaknesses in the design or and these amendments will not, appear in statements were made, not misleading operation of internal control over the Code of Federal Regulations. with respect to the period covered by financial reporting which are reasonably this report; likely to adversely affect the registrant’s FORM N–CSR 3. Based on my knowledge, the ability to record, process, summarize, * * * * * financial statements, and other financial and report financial information; and

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(b) Any fraud, whether or not 270.30a-2(b)), Rule 13a-14(b) or Rule the registrant specifically incorporates it material, that involves management or 15d-14(b) under the Exchange Act (17 by reference. other employees who have a significant CFR 240.13a-14(b) or 240.15d-14(b)), role in the registrant’s internal control and Section 1350 of Chapter 63 of Title Instruction to Item 10. over financial reporting. 18 of the United States Code (18 U.S.C. Letter or number the exhibits in the Date: 1350) as an exhibit. A certification sequence that they appear in this item. lllllllllllllllllllll furnished pursuant to this paragraph lllllllllllllllllllll will not be deemed ‘‘filed’’ for purposes * * * * * [Signature] of Section 18 of the Exchange Act (15 By the Commission. lllllllllllllllllllll U.S.C. 78r), or otherwise subject to the Dated: June 5, 2003. [Title] liability of that section. Such (b) If the report is filed under Section certification will not be deemed to be J. Lynn Taylor, 13(a) or 15(d) of the Exchange Act, incorporated by reference into any filing Assistant Secretary. provide the certifications required by under the Securities Act of 1933 or the [FR Doc. 03–14640 Filed 6–13–03; 8:45 am] Rule 30a-2(b) under the Act (17 CFR Exchange Act, except to the extent that BILLING CODE 8010–01–P

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Part III

Department of Health and Human Services Food and Drug Administration

21 CFR Part 314 Applications for FDA Approval To Market a New Drug: Patent Submission and Listing Requirements and Application of 30-Month Stays on Approval of Abbreviated New Drug Applications Certifying That a Patent Claiming a Drug Is Invalid or Will Not Be Infringed; Final Rule

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DEPARTMENT OF HEALTH AND SUPPLEMENTARY INFORMATION: information can affect the approval of ANDA and 505(b)(2) applications. (We HUMAN SERVICES I. Introduction will refer to these as ‘‘ANDA and Food and Drug Administration This final rule revises implementing 505(b)(2) applicants’’ or ‘‘ANDA or regulations in part 314 (21 CFR part 505(b)(2) applicants’’ and refer to their 21 CFR Part 314 314) for certain statutory amendments to applications as ‘‘ANDA and 505(b)(2) the act, 21 U.S.C. 301 et seq., relating to [Docket No. 02N–0417 ] applications’’ or ‘‘ANDA or 505(b)(2) new drug applications and generic drug applications’’ throughout the remainder RIN 0910–AC48 approvals. The statutory provisions of the preamble of this document.) were added to the act through the Drug Section 505(b)(1) of the act (21 U.S.C. Applications for FDA Approval to Price Competition and Patent Term 355(b)(1)) requires all NDA applicants to Market a New Drug: Patent Submission Restoration Act of 1984 (Public Law 98– file, as part of the NDA, ‘‘the patent and Listing Requirements and 417 (21 U.S.C. 355, 360cc; 35 U.S.C. number and the expiration date of any Application of 30-Month Stays on 156, 271, 282) (‘‘Hatch-Waxman patent which claims the drug for which Approval of Abbreviated New Drug Amendments’’)). These statutory the applicant submitted the application Applications Certifying That a Patent provisions reflect an attempt to balance or which claims a method of using such Claiming a Drug Is Invalid or Will Not two competing interests: Promoting drug and with respect to which a claim Be Infringed competition between ‘‘brand-name’’ or of patent infringement could reasonably ‘‘innovator drugs’’ and ‘‘generic’’ drugs, AGENCY: Food and Drug Administration, be asserted if a person not licensed by and encouraging research and HHS. the owner engaged in the manufacture, innovation. The act promotes ACTION: Final rule. use, or sale of the drug.’’ Section competition by creating a process to 505(c)(2) of the act (21 U.S.C. 355(c)(2)) SUMMARY: The Food and Drug expedite the filing and approval of imposes a similar patent submission Administration (FDA) is amending its ANDA and 505(b)(2) drug applications obligation on holders of approved NDAs patent submission and listing (applications submitted under the when the NDA holder could not have requirements for new drug applications provisions of section 505(b)(2) of the submitted the patent information with (NDAs). The final rule clarifies the types act) and for resolving challenges to its application. of patents that must and must not be patents in court before marketing Under section 505(b)(1) of the act, we submitted and revises the declaration begins. At the same time, the act publish patent information after that NDA applicants must provide encourages research and innovation by approval of an NDA application in our regarding their patents to help ensure protecting the patent interests of the approved drug products list entitled that NDA applicants submit only patent owner and innovator drug ‘‘Approved Drug Products With appropriate patents. The final rule also company. Therapeutic Equivalence Evaluations.’’ The final rule maintains a balance revises the regulations regarding the This list is known popularly as the between the innovator companies’ effective date of approval for certain ‘‘Orange Book’’ because of its orange- intellectual property rights and the abbreviated new drug applications colored cover. If patent information is desire to get generic drugs on the market (ANDAs) and certain other new drug submitted after NDA approval, section in a timely fashion. The final rule limits applications, known as 505(b)(2) 505(c)(2) of the act directs us to publish to one per ANDA or 505(b)(2) applications, submitted under the the information upon its submission. application the maximum number of Federal Food, Drug, and Cosmetic Act The act also requires ANDA or statutory 30-month stays of approval to (the act). In certain situations, Federal 505(b)(2) applicants to make which an innovator will be entitled law bars FDA from making the approval certifications regarding each of the when it submits multiple patents for the of certain ANDA and 505(b)(2) listed patents pertaining to the drug same NDA. Eliminating multiple 30- applications effective for 30 months if they intend to reference (see sections month stays will speed up the approval the applicant has certified that the 505(b)(2)(A)(i) through (b)(2)(A)(iv) and and market entry of generic drugs. The patent claiming a drug is invalid or will 505(j)(2)(A)(vii)(I) through final rule also clarifies patent not be infringed, and the patent owner (j)(2)(A)(vii)(IV) of the act (21 U.S.C. submission and listing requirements, or NDA holder then brings suit for 355(b)(2)(A)(i) through (b)(2)(A)(iv) and which will reduce confusion and help patent infringement. The final rule also 21 U.S.C. 355(j)(2)(A)(vii)(I) through curb attempts to take advantage of this states that there is only one opportunity (j)(2)(A)(vii)(IV)). In brief, these process. Specifically, patents claiming for a 30-month stay in the approval date certifications state that: packaging, intermediates, or metabolites of each ANDA and 505(b)(2) • Patent information has not been must not be submitted for listing. application. The final rule will make the filed, Patents claiming a different patent submission and listing process • The patent has expired, polymorphic form of the active more efficient as well as enhance the • The patent will expire on a specific ingredient described in the NDA must ANDA and 505(b)(2) application date, or be submitted if the NDA holder has test • approval processes. The patent is invalid or will not be data demonstrating that a drug product infringed. DATES: Effective Date: This final rule is containing the polymorph will perform If the ANDA or 505(b)(2) applicant effective on August 18, 2003. the same as the drug product described certifies that the patent is invalid or will Compliance Date: The compliance in the NDA. date is December 18, 2003, for the not be infringed (a certification known submission of information on A. What Are the Statutory Provisions as a ‘‘paragraph IV’’ certification polymorph patents. Which Affect Patent Submissions and because it is the fourth type of patent certification described in the act1), the FOR FURTHER INFORMATION CONTACT: the Approval of New Drugs? act requires the applicant to notify the Jarilyn Dupont, Office of Policy and To explain why we (FDA) issued the Planning (HF–11), Food and Drug proposal, we first describe how Federal 1 Paragraph IV throughout also refers to paragraph Administration, 5600 Fishers Lane, law requires NDA applicants to file iv, the comparable provision in section 505(b)(2)(A) Rockville, MD 20857, 301–827–3360. patent information and how that patent of the act.

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NDA holder and patent owner (see proposed to clarify our regulatory polymorphic form of the active sections 505(b)(3) and 505(j)(2)(B) of the policies regarding patent submission, ingredient described in the NDA; act (21 U.S.C. 355(b)(3) and 355(j)(2)(B)). listing, certification, and notice. We also • Adds a requirement that for The notice states that an ANDA or issued the proposal to respond, in part, submission of polymorph patents the 505(b)(2) application containing a to concerns raised by the Bureau of NDA holder must have test data paragraph IV certification to a listed Competition and the Policy Planning demonstrating that a drug product patent has been submitted for the NDA Staff of the Federal Trade Commission containing the polymorph will perform holder’s approved drug product (known (FTC). On May 16, 2001, the FTC the same as the drug product described as the ‘‘listed drug’’). The notice also submitted a citizen petition to FDA in the NDA; includes a ‘‘detailed statement of the (FDA docket number 01P–0248) (‘‘FTC • Makes changes to the patent factual and legal basis of the applicant’s Citizen Petition’’) asking for guidance information required to be submitted opinion that the patent is not valid or concerning the criteria that a patent and provides declaration forms for will not be infringed’’ (id.). If the NDA must meet before it is listed in the submitting that information to FDA, holder or patent owner brings an action Orange Book. The FTC Citizen Petition both with the NDA and after NDA for patent infringement within 45 days asked us to clarify several patent listing approval; and after notice of the paragraph IV issues and indicated that the FTC was • certification has been received, then we conducting an extensive study of Does not require claim-by-claim may not make the approval of an ANDA generic drug competition. listing on the declaration form except or 505(b)(2) application effective for 30 In July 2002, the FTC published the for method-of-use patents claiming months, or such shorter or longer period results of the study in a report entitled approved methods of use. as a court may order, or until the date ‘‘Generic Drug Entry Prior to Patent II. Comments on the Proposed Rule of a court decision (see sections Expiration: An FTC Study’’ (‘‘FTC 505(c)(3)(C) and 505(j)(5)(B)(iii) of the Report’’). The FTC Report focused on We received over 35 comments on the act (21 U.S.C. 355(c)(3)(C) and the procedures used to facilitate a proposed rule. The comments 355(j)(5)(B)(iii)). (We will refer to the generic drug’s entry into the market represented a diverse range of interests date the approval of an ANDA or before the expiration of a patent or such as: Health insurance programs, 505(b)(2) application is made effective patents that claim the brand-name drug brand name pharmaceutical companies, as the ‘‘approval date’’ throughout the product. The FTC also recommended generic pharmaceutical companies, law remainder of this preamble.) changing Federal law to ‘‘permit only firms, consumer organizations, one automatic 30-month stay per drug pharmacy associations, the FTC, the B. What Did the Proposed Rule Say? product per ANDA to resolve New York Department of Health, large In the Federal Register of October 24, infringement disputes over patents corporations, and individuals. In 2002 (67 FR 65448), we published a listed in the Orange Book prior to the general, most comments supported the proposed rule (proposed rule) that filing date of the generic applicant’s rule, either in whole or in part, and would address: ANDA’’ (see FTC Report at page ii). The believed that the rule would help • The types of patents that must and FTC Report explained ‘‘To permit only reduce prescription drug costs by must not be submitted by NDA one 30-month stay per drug product per making generic drugs available more applicants and NDA holders or patent ANDA should eliminate most of the quickly. However, other comments owners (for purposes of this preamble, potential for improper Orange Book opposed the rule because they felt we an NDA applicant is someone who is listings to generate unwarranted 30- had misinterpreted the act or because seeking FDA approval of a specific new month stays’’ (id. at page v (footnote they felt that new legislation, rather drug application or supplement, omitted)). In an appendix to its report, than a regulation, was necessary. We whereas an NDA holder is someone the FTC asked us to issue a regulation describe the comments, and our whose NDA we have approved); or guidance clarifying whether an NDA responses to the comments, in this • The types of patents that we will list holder could submit various types of section. To make it easier to identify the in the Orange Book; patents for listing in the Orange Book. comments and our responses, the word • The patent declaration that NDA The types of patents for which the FTC ‘‘Comment’’ in parentheses, will appear applicants must submit as part of an sought clarification were patents that before the description of the comment, NDA, an amendment, a supplement, or claimed metabolites, polymorphs, and the word ‘‘Response’’ in when submitting information on a intermediates, product-by-process parentheses, will appear before our newly issued patent; and • patents, and double patents (see FTC response. We also have numbered each The 30-month stay of the effective Report at pages A–39–A–45). comment to make it easier to identify a date of approval for an ANDA or particular comment. The number C. What Does This Final Rule Do? 505(b)(2) application. assigned to each comment is only for The preamble to the proposed rule The comments received expressed organizational purposes. It does not noted that, on occasion, we have seen both support for, and opposition to, signify the comment’s value, NDA holders submit new patents for various provisions of the proposed rule. importance, or the order in which we listing shortly before other listed patents After careful review of these comments, received it. for the same drug were to expire (see 67 we are making final most of the FR 65448 at 65449). We explained that, provisions of the proposed rule with A. Comments on Specific Aspects of the in some disputes over recently listed certain modifications. The final rule: Proposed Rule • patents, the parties had questioned Allows a full opportunity for only 1. What Patents Must and Must Not Be whether particular patents met the one 30-month stay per ANDA or Submitted? (Section 314.53(b)) regulatory requirements for submission 505(b)(2) application; and listing in the Orange Book. These • Prohibits the submission of patents Proposed § 314.53(b) would require disputes sometimes resulted in judicial claiming packaging, intermediates, or NDA applicants and holders or patent decisions that are inconsistent with our metabolites; owners to submit information on the regulatory policies or our interpretation • Requires the submission of certain following types of patents for listing in of our own regulations (id.). We patents claiming a different the Orange Book. In brief, the proposed

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rule would clarify that we would list purposes as including certain drug applicant or holder is able to establish only patents that claim: substances having different physical that a polymorph claimed in a patent is • The drug substance (ingredient); forms if they would be considered the the ‘‘same’’ active ingredient (i.e., that a • The drug product (formulation and same active ingredient for ANDA drug product containing the polymorph composition); and approval purposes (id.). will perform the same as the drug • Method of use. We invited comment on whether we product described in the NDA with Proposed § 314.53(b) would not allow should revise the codified language to respect to such characteristics as listing of process patents and patents require an NDA holder to submit dissolution, solubility, and claiming packaging, metabolites, or additional information regarding the bioavailability), the NDA applicant or intermediates. basis for its assertion that the drug holder must submit the patent to us for a. Patents Claiming a Drug substances are the ‘‘same’’ active listing. We acknowledge that there may Substance—Must Patents that Claim the ingredient. We also invited comment on be some legitimate confusion regarding ‘‘Same’’ Active Ingredient Be Submitted the potential impact of the change our prior position concerning and Listed? For patents that claim a (allowing the submission of patents submission of such patents for listing, drug substance, the proposal stated that claiming different polymorphs) on the which resulted in the listing of some an applicant ‘‘shall submit information submission of ANDA and 505(b)(2) polymorph patents in the Orange Book. only on those patents that claim the applications. The uncertainty over our policy resulted form of the drug substance that is the (Comment 1) Several comments from certain court decisions, our subject of the pending or approved disagreed with our proposal to allow response to those court decisions, and application or that claim a drug listing of patents claiming different other public statements. The FTC substance that is the same as the active polymorphs of the active ingredient in ingredient that is the subject of the Citizen Petition highlighted the need for the listed drug. Some comments stated clarification and is one reason we approved or pending application.’’ We that section 505(b)(1) of the act requires explained that an NDA applicant or decided to implement this final rule and the patent to claim the drug substance clarify our position. For the reasons holder would determine whether the that is the subject of the NDA. Several drug substance was the ‘‘same’’ as the explained in the preamble to the comments asserted that a patent proposed rule (see 67 FR 65448 at 65452 active ingredient in the NDA by claiming a polymorph that was not the considering ‘‘whether the drug to 65453), it is appropriate to have a subject of an NDA did not satisfy consistent interpretation of the substances can be expected to perform section 505(b)(1) of the act. Other the same with respect to such ‘‘sameness’’ principle in the patent comments argued that ‘‘sameness’’ for listing and ANDA approval contexts. characteristics as dissolution, solubility, ANDA approval purposes differed from and bioavailability’’ (see 67 FR 65448 at Accordingly, we will not treat ‘‘sameness’’ in patent law, so we did not polymorphs differently for patent 65452). have to develop an identical submission and listings and ANDA Drug substances that are the same interpretation of the two concepts. approval. The argument that certain active ingredient, but that are in Several comments maintained that no polymorph patents should never have different physical forms, are often called such patents could exist if the active been issued is not a matter for us to ‘‘polymorphs.’’ For example, the ingredients were truly the ‘‘same’’ address. The Patent and Trademark different crystalline forms of a drug because a subsequent patent for the Office (PTO) is responsible for substance are sometimes known ‘‘same’’ active ingredient should not reviewing and issuing patents. We will collectively as polymorphs, and drug have been issued. Some comments not question whether the PTO should substances with different waters of agreed that patents claiming different have issued a particular patent, nor will hydration are sometimes referred to as polymorphs of the same active ‘‘polymorphs’’ as well. (For purposes of ingredient should be listed, but only we conduct a ‘‘patent law’’ or other this final rule, polymorphs include with submission of additional analysis to determine ‘‘sameness.’’ chemicals with different crystalline information such as clinical trial data We agree with the comments that structures, different waters of hydration, required for FDA approval or proof that suggested we needed to take additional solvates, and amorphous forms.) Under ‘‘sameness’’ is beneficial. A few steps to help ensure that the submitted the proposed rule, an NDA applicant or comments maintained that the proposal patents claim the ‘‘same’’ active holder would be required to submit a did not change our pre-existing position ingredient as that described in the NDA. patent claiming a different polymorph because we have permitted NDA A polymorph patent must claim the from that of the drug substance holders and applicants to submit drug substance (active ingredient) to described in the NDA if a drug product patents claiming different polymorphs meet the statutory requirements for containing the polymorph will perform of the active ingredient. In response to submission. We have modified the the same as the drug product described our request for comment on the impact declaration requirement and created in the NDA with respect to dissolution, on ANDA and 505(b)(2) applications, forms to help ensure that the NDA solubility, and bioavailability. one comment expressed the belief that applicant or holder or patent owner The proposed rule would make the listing patents claiming different confirms that the patent does claim the patent listing standards generally polymorphs of the active ingredient ‘‘same’’ active ingredient. The final rule consistent with the ANDA approval would reduce the ability of generic and the declaration forms require that standards. For ANDA approval manufacturers to ‘‘design around’’ the the NDA applicant or holder or patent purposes, the active ingredient in a existing patents, an option which was owner certify that test data exist generic drug product can be the ‘‘same’’ contemplated by the Hatch-Waxman demonstrating that a drug product as that in the reference listed drug Amendments. containing the polymorph will perform notwithstanding differences in the (Response) We decline to modify our the same as the drug product described physical forms of their active ingredient position taken in the proposed rule in the NDA. If a patent claims more than if the drug product performs the same. which would require patents to be one polymorph, each polymorph for Thus, we stated that it would be submitted for listing that claim different which the required test data are consistent to interpret ‘‘drug substance’’ polymorphs of the active ingredient available must be identified by claim or for patent submission and listing described in the NDA. If the NDA description in the declaration forms.

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The final rule does not require these • Comparative in vitro dissolution might not be readily apparent to persons tests to be submitted to FDA at the time testing on 12 dosage units each of the who are unfamiliar with patent law. We of patent submission, nor does it require executed test batch and the NDA sought comment on ways to ensure that the NDA applicant or holder to conduct product. only appropriate product-by-process the tests itself. The testing requirements, This test data requirement corresponds patents are listed in the Orange Book. however, will ensure that only relevant to the test data required of ANDA (Comment 2) Several comments polymorphs are submitted for listing. applicants to demonstrate the drug argued that product-by-process patents Whether two different polymorphs are product containing the polymorph must not be listed. Some comments the ‘‘same’’ active ingredient for described in the ANDA will perform the stated that product-by-process patents purposes of drug approval is a scientific same as the drug product described in ‘‘closely resemble’’ process patents and determination based upon the specific the NDA. In addition to the data that the act does not allow listing of characteristics of the forms of the drug requirements described in our process patents. One comment asserted substance involved. Only with testing regulations cited above (§§ 314.50 and that listing product-by-process patents can the scientific determination be 314.94), we have published guidance would have a ‘‘profound negative made that the drug product containing documents describing the test data effect’’ on generic drug approvals the polymorph will perform the same as ANDA applicants may use to because NDA applicants and holders or the drug product described in the NDA. demonstrate that the drug product will patent owners would attempt to list any The test data that the NDA applicant or perform the same as the drug product product-by-process patent, whether or holder or patent owner must certify described in the NDA. (See ‘‘Guidance not the process defined in the patent exist at the time of patent submission for Industry: Changes to an Approved was actually used to manufacture the are similar to the type of information NDA or ANDA’’ (November 1999) and drug product approved in the NDA. required under §§ 314.50 and 314.94. ‘‘Guidance for Industry: Immediate Similarly, other comments sought to The following explains more fully the Release Solid Oral Dosage Forms CMS limit the type of product-by-process required tests or data that would 5’’ (November 1995); these guidances patents that could be listed. Several support the statement in the declaration are available at www.fda.gov/opacom/ comments would revise the rule to forms: morechoices/industry/guidedc.htm.) require the product-by-process patent to The stringency of these requirements claim a ‘‘novel’’ product, so that if the • A full description of the regarding ‘‘sameness’’ also should drug product described by the product- polymorphic form of the drug address the concerns that the by-process patent was a ‘‘known’’ drug substance, including its physical and submission of polymorph patents might product or the product already had been chemical characteristics and stability; lead to submission of other patents listed in the Orange Book, we would not the method of synthesis (or isolation) claiming components which are not, but list the product-by-process patent. In and purification of the drug substance; might be, included in a drug described other words, the comments sought to the process controls used during in an NDA. Given the narrow legal and ensure that the product-by-process manufacture and packaging; and such scientific basis for submission of patent covered a product that was ‘‘new specifications and analytical methods as polymorph patents, the final rule does and patentably distinct’’ from are necessary to assure the identity, not open the door to submission of any previously-approved drug products. strength, quality, and purity of the patents claiming formulations or One comment suggested adding a new polymorphic form of the drug inactive ingredients not contained in the paragraph to the patent declaration to substance; • drug product described in the NDA. read as follows: The executed batch record for a drug We believe that these changes will F. For each drug substance or drug product product containing the polymorphic help deter submission of inappropriate claim that was (1) identified as listable in form of the drug substance and polymorph patents. The assumption subparts B and C and (2) is drafted in documentation that the batch was that a product containing a polymorph product-by-process format, please provide manufactured under current good the following information: will perform the same as the product 1. Is the product of the recited process manufacturing practice requirements; containing a different polymorph and • novel? [If the answer to question F.1 is ‘‘no,’’ Demonstration of bioequivalence described in the NDA will have to be stop. The patent cannot be listed. If yes, between the executed batch of the drug substantiated. please identify the claim(s) by number.] product that contains the polymorphic b. Product-by-Process Patents— Another comment thought that few form of the drug substance and the drug Should These Patents Be Listed? drugs would be the subject of a product- product as described in the NDA; Proposed § 314.53(b) would allow an by-process patent. The comment • A list of all components used in the NDA applicant or holder or patent recommended that we investigate any manufacture of the drug product owner to submit information on product-by-process patents that were containing the polymorphic form and a product-by-process patents. The act listed in the Orange Book to see if these statement of the composition of the drug requires that NDA holders submit related to the NDA drug product. Yet product; a statement of the patents that claim the drug product. another comment would amend the specifications and analytical methods However, NDA applicants or holders patent declaration to identify the for each component; a description of the must not submit patents that claim a product-by-process claims in the patent, manufacturing and packaging process for making that product. the effective filing date of the patent procedures and in-process controls for We explained that a product-by- application, whether the product has the drug product; such specifications process patent claims a product by been previously sold, and, if the product and analytical methods as are necessary describing or listing process steps to had been previously sold, whether such to assure the identity, strength, quality, wholly or partially define the claimed sales occurred more than 1 year before purity, and bioavailability of the drug product. In a product-by-process patent, the effective filing date of the patent product, including release and stability the patented, novel invention is the application. The comment explained data complying with the approved product and not the process that is used that if the drug’s active ingredient has product specifications to demonstrate to make the product. We recognized that been previously sold for more than 1 pharmaceutical equivalence and the distinction between a product-by- year before the effective filing date of comparable product stability; and process patent and a process patent the product-by-process patent

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application, the patent would be 505 of the act typically are capable of proposed rule would prohibit ineligible for listing because the patent being described by their chemical submission and listing of a patent would violate a specific provision in formula. Most such drug products claiming a metabolite of the approved patent law. approved are not of the type that can be drug. A metabolite is the chemical In contrast, three comments described only in terms of the process compound that results after the active supported listing product-by-process used to produce the product. We ingredient of the drug has broken down patents. These comments agreed that decline to add any additional questions inside the body. We explained that a product-by-process patents are a form of to the declaration relating to the patent claiming a metabolite does not a product patent. Two comments stated patented product’s length of time in the claim the approved drug, as required by that we did not need to revise the rule commercial market or other related the act, because the metabolite exists to distinguish between product-by- questions, as we believe that the only after the approved drug has been process patents (which must be listed) declaration questions we have added broken down inside the body (see 67 FR and process patents (which must not be will accomplish the clarification at 65451). listed). The comment suggested revising necessary to prevent the submission of (Comment 4) Most comments agreed § 314.53(b) to replace its mention of process patents. with our exclusion of patents claiming product-by-process patents with c. Patents Claiming Packaging—Do a metabolite. One comment, however, ‘‘patents that claim the drug substance We Consider Containers and Delivery asked whether we would list ‘‘a patent or drug product at least in part in terms Systems to be ‘‘Packaging?’’ Proposed that claims a method of using an of its method of manufacture (product- § 314.53(b) would not have allowed an approved drug to administer a by-process patents).’’ applicant to list a patent that claimed metabolite.’’ The comment (Response) We agree that, to be packaging. distinguished a method-of-use patent submitted for listing, the product-by- (Comment 3) Most comments agreed from a patent that claimed the process patent must claim the drug that patents claiming packaging should metabolite. product that is the subject of the NDA. not be submitted for listing. However, (Response) The final rule prohibits We explained in the proposed rule why some comments stated that patents submission of patents claiming a product-by-process patent is a type of claiming devices or containers that are metabolites when the metabolite is not product patent (see 67 FR 65448 at ‘‘integral’’ to the drug product or require the active ingredient described in the 65452). We also agree that the prior FDA approval should be submitted NDA. The submission of a metabolite declaration should be clear enough to and listed. These comments patent does not meet the legal ensure that the patents that are distinguished between packaging and requirements for patent submissions as submitted for listing are product-by- devices such as metered dose inhalers discussed in the proposed rule (see 67 process patents and not process patents. and transdermal patches, which are FR 65448 at 65451). By contrast, if a In the response to comment 12 in drug delivery systems used and patent submitted for listing claimed an section II.A of this document we detail approved in combination with a drug. approved method of using an approved the changes we have made to the (Response) We agree that patents drug to administer a metabolite, the declaration (including declaration claiming a package or container must submission of the patent would be forms) to help ensure that the patents not be submitted. Such packaging and permissible as long as all the conditions submitted for listing are patents that containers are distinct from the drug for submitting ‘‘method-of-use’’ patents claim the drug product that is the product and thus fall outside of the are met. We describe the requirements subject of the NDA and do not claim the requirements for patent submission. for submission of method-of-use patents process that is used to manufacture the However, we have clarified the rule to in the response to comment 7 in section drug product. ensure that if the patent claims the drug II.A of this document. Briefly, if a The declaration forms include a product as defined in § 314.3, the patent method of use is described in the question which requires the NDA must be submitted for listing. labeling for the drug product, and there applicant or holder or patent owner to Section 314.3 defines a ‘‘drug is a patent claiming that method of use, certify whether the patent being product’’ as ‘‘***a finished dosage the patent must be submitted for listing submitted is a product-by-process form, for example, tablet, capsule, or in the Orange Book, the method-of-use patent in which the product claimed is solution, that contains a drug substance, claim must be identified in the novel. Although we do not adopt the generally, but not necessarily, in declaration forms, and the labeling wording suggested by several association with one or more other language related to the method-of-use comments, we agree that a requirement ingredients.’’ The appendix in the claim must be provided in the to identify the product as novel will Orange Book lists current dosage forms declaration forms. help ensure that the patent is a product- for approved drug products. The list e. Patents Claiming Intermediates— by-process patent. We acknowledge that includes metered aerosols, capsules, Must We Allow Them to Be Submitted? when the PTO issues a patent, the PTO metered sprays, gels, and pre-filled drug The proposed rule would not allow the necessarily determines that some aspect delivery systems. The key factor is submission of patents that claimed an of the patent claims is ‘‘novel.’’ We want whether the patent being submitted intermediate. We explained that to make sure that the NDA applicant or claims the finished dosage form of the intermediates are materials that are holder or patent owner is identifying the approved drug product. Patents must produced during preparation of the product claim as the novel aspect. This not be submitted for bottles or active ingredient and are not present in clarification should eliminate the containers and other packaging, as these the finished drug product. We consider submission of patents that may be are not ‘‘dosage forms.’’ The revised intermediates to be ‘‘in-process mistakenly identified as product-by- declaration requirements, described in materials’’ rather than drug substances process patents but, in reality, are the response to comment 12 in section or components in the finished drug process patents which cannot be II.A of this document, detail the product (see 67 FR 65448 at 65451 to submitted for listing. information required for submission. 65452). We expect that product-by-process d. Patents Claiming Metabolites—Are (Comment 5 and Response) The patents will not be submitted often. Any Patents Claiming Metabolites comments that addressed this issue Drug products approved under section Eligible for Submission and Listing? The agreed with the proposal. Consequently,

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the final rule does not allow submission terminal disclaimer. As long as the claims the drug for which the applicant of patents that claim intermediates for patent meets the statutory requirements, submitted the application or which the reasons explained in the proposal. the patent must be submitted, even if it claims a method of using such f. ‘‘Double’’ Patents—What Are They, contains a terminal disclaimer. Again, drug***.’’ The corresponding and Must We Allow Them to Be we note that the PTO is responsible for language in section 505(c)(2) of the act Submitted? The proposal did not the issuance of such patents. We defer is nearly identical. Only method-of-use discuss ‘‘double’’ patents. to the PTO on matters of patent patents ‘‘which claim the drug for (Comment 6) One comment suggested issuance. which the applicant submitted the that we prohibit the listing of patents g. Method-of-Use Patents—Must the application’’ must be listed. ‘‘Drug’’ is that contain a terminal disclaimer over ‘‘Use’’ Be Approved in the Approved an ambiguous term, one which, for a patent that had already been listed. Drug Product? The preamble to the many years, we have consistently The comment explained that patent law proposed rule mentioned that patents interpreted in the Hatch-Waxman generally prevents an inventor from claiming a method of use would be able Amendments to refer to the drug double patenting—that is, extending the to be submitted, but did not address product. One court has said that: term of the patent ‘‘by the subsequent such patents except to confirm our The meaning of the word ‘‘drug’’ in 21 patenting of variations that are not position that patents may not be U.S.C.§ 355(b)(1) cannot be determined apart patentably distinct from the first- submitted for listing if they claim from its context. Neither the FDA nor this patented invention.’’ The comment methods of use that are not approved for court disputes that the definition of drug in stated that this ‘‘double patenting’’ can § 321(g) covers both drug products and active the listed drug or are not the subject of ingredients. The relevant statutory section in be cured if the patent holder files a a pending application. this case, however, modifies the word ‘‘drug’’ ‘‘terminal disclaimer’’ which ‘‘acts to (Comment 7) Comments disagreed as by attaching the phrase ‘‘for which the disclaim the term of the later patent that to whether the method-of-use claim in applicant submitted the application.’’ In that extends beyond the term of the original a patent submitted for listing must be a context the FDA’s interpretation of drug as patent, so that both patents expire on use approved in the NDA. Several meaning drug product is consistent with and the same day.’’ The comment expressed comments urged us to list only those indeed required by the statute. concern that NDA holders could list a patents claiming methods of use (See Pfizer, Inc. v. FDA, 753 F. Supp. later patent and have an opportunity to approved in the NDA or that required 171, 176 (D. Md. 1990).) All of the obtain a 30-month stay even if the later clinical trials. One comment argued that benefits afforded NDA holders under listed patent had a terminal disclaimer. listing only patents for approved uses the Hatch-Waxman Amendments, such In other words, the terminal disclaimer was the only way to stop NDA holders as the 30-month stay, derive from would prevent the inventor from from claiming broad uses or indications obtaining our approval of a particular enjoying a longer term of patent not in the approved labeling. In drug product. Accordingly, only protection, but it would not prevent the contrast, other comments argued that method-of-use patents that claim a use imposition of another 30-month stay if the act did not prevent NDA applicants of the drug product in the pending or the NDA holder or patent owner sued to or holders or patent owners from approved application must be enforce the later patent. The comment submitting patents for listing that submitted. Method-of-use patents for noted that, for the drugs PAXIL and claimed uses not approved by FDA. uses that the NDA holder ‘‘has not FOSAMAX, the NDA holder had Some comments stated that patent chosen to make available to the public’’ submitted earlier patents and a later- infringement is not limited to approved (id. at 177) must not be submitted for issued patent that had a terminal uses. Other comments stated that listing. disclaimer. The patents were listed in section 505(b)(1) of the act contemplates This construction of the statute is also the Orange Book, paragraph IV the listing of patents claiming supported by the more recent case law. certifications were required for both unapproved uses if a claim of patent Since we issued the proposed rule, there patents and the NDA holder sued ANDA infringement could reasonably be have been several judicial opinions applicants on both patents, triggering asserted, citing Purepac Pharm. Co. v. discussing method-of-use patents. In 30-month stays. Thompson, 238 F. Supp. 2d 191 (D.D.C. Purepac Pharm. Co. v. Thompson, 238 (Response) We acknowledge that the 2002) (Purepac). F. Supp. 2d 191 (D.D.C. 2002), and in ‘‘double patenting’’ described by the (Response) If an NDA applicant or the related case TorPharm, Inc. v. comment may, indeed, provide an NDA holder or patent owner intends to Thompson, Civ. No. 03–0254 (D.D.C. holder an opportunity to obtain an submit information on a patent that April 25, 2003) (appeal pending for both additional 30-month stay under the claims a method of use, the patent must Purepac and TorPharm), the district prior interpretation of the act. Under the claim a use that is described in the court held that, where a patent did not final rule, there is no opportunity for NDA. If we have already approved the claim a use approved in the NDA, an multiple 30-month stays if patents with NDA, the patent must claim a method ANDA applicant could not be required terminal disclaimers are submitted for of use that is in the labeling of the to certify to that patent, and the agency listing. If such a patent is submitted approved NDA. This has been our could properly find that no ANDA after an ANDA applicant has filed a position since before we issued the final applicant was entitled to 180-day paragraph IV certification to a patent information rule in 1994 (see 59 exclusivity on that patent. In Warner- previously filed patent, and one full FR 50338, 50363–50364 (Oct. 3, 1994)). Lambert Co. v. Apotex Corp., 316 F.3d opportunity was provided for the 30- The pre-existing requirement can be 1348 (Fed. Cir. 2003), the Federal month stay, no notice need be given for found at § 314.53(b) and (c)(2). Circuit held that an ANDA applicant a subsequent paragraph IV certification Sections 505(b) and (c) of the act does not need to certify to a patent and no additional 30-month stay for that support our position that only patents claiming a use not covered by the ANDA applicant can result under the claiming approved methods of use be applicable NDA, and there is no cause final rule. submitted for listing. Section 505(b)(1) of action against an ANDA applicant for The act expressly contemplates listing of the act provides that the NDA patent infringement under 35 U.S.C. of patents after NDA approval. It does applicant ‘‘shall file with the 271(e)(2)(A) for patents that claim an not prevent an NDA holder or patent application the patent number and the unapproved use. In Allergan, Inc. v. owner from submitting a patent with a expiration date of any patent which Alcon Labs., Inc., 324 F.3d 1322 (Fed.

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Cir. 2003), the Federal Circuit issued a then to litigation over an ANDA section viii statement provisions under per curium opinion that held that a applicant’s obligation to submit either a sections 505(b)(2)(B) and method-of-use patent holder does not paragraph IV certification under section 505(j)(2)(A)(viii) of the act that intersect have an infringement action against an 505(j)(2)(A)(vii)(IV) of the act or a with the patent submission ANDA applicant when the use claimed ‘‘section viii’’ statement under section considerations described in the in the patent is not FDA approved and 505(j)(2)(A)(viii) of the act. The section proposed rule. One approach would be the ANDA applicant is not seeking viii statement, which is also applicable to permit each ANDA and 505(b)(2) approval of that use. These decisions are to 505(b)(2) applications, permits the applicant to make its own independent consistent with our position that ANDA or 505(b)(2) applicant to avoid decision on whether a listed method-of- sponsors must not submit method-of- certifying to a patent by stating that it use patent claims the use for which the use patents that do not claim an is not seeking approval for the use ANDA applicant seeks approval, and approved use for listing in the Orange claimed in the listed patent. A section then to submit a paragraph IV Book. They also highlight the need for viii statement does not carry the certification or section viii statement as an improved declaration that will clarify requirement for notice to the NDA the applicant sees fit. The second the claimed scope of the method-of-use holder and patent owner, and the approach would be to require the NDA patents being submitted. related opportunity for a 30-month stay. applicant or holder to identify We have modified the required We have implemented the section viii specifically the approved uses claimed declaration relating to method-of-use provisions of the act by deferring to the by the method-of-use patent, with patents submitted. Although we agree, NDA holder’s or patent owner’s reference to the approved labeling, and as discussed in the response to assertion that the method-of-use patent declare under penalty of perjury that the comment 11 of section II.A of this claims an approved use of the drug patent claims an approved use. This document, that each individual claim of product. When the NDA holder or would permit ANDA and 505(b)(2) a patent does not need to be listed on patent owner submits a method-of-use applicants, and us, to assess whether the the declaration forms for drug substance patent for an approved NDA, we rely ANDA or 505(b)(2) applicant is seeking and drug product patents, we do require upon the requirements in the approval for a use the sponsor states is identification of individual claims for regulations and the required declaration claimed in the listed patent, and thus method-of-use patents. The declarant as the evidence that the patent claims an determine whether the applicant must must describe each individual method approved use. Therefore, when an submit a patent certification or may of use for which a patent is submitted ANDA applicant has sought to duplicate submit a section viii statement under for listing, and identify the the labeling for which the innovator has section 505(b)(2)(B) or 505(j)(2)(A)(viii) corresponding language found in the submitted the patent, and not to of the act. labeling of the approved NDA that specifically omit, or ‘‘carve out’’ In the absence of explicit statutory corresponds to that method of use. This labeling, we require the ANDA language, we believe an approach that information will expedite our review of applicant to submit a certification to requires the NDA applicant or holder or ANDA and 505(b)(2) applications that that patent. A section viii statement patent owner to identify the approved do not seek approval for all the would not be appropriate because the methods of use protected by the patent approved uses. In determining whether ANDA applicant is seeking approval for is most consistent with the general an ANDA applicant can ‘‘carve out’’ the exactly the same labeling as that in the balance adopted in Hatch-Waxman. method of use, rather than certify to the NDA for which the patent was This approach permits the NDA listed patent, we will rely on the submitted. applicant or holder to determine which description of the approved use Our position has been that, for an patents claim its approved drug product provided by the NDA holder or patent ANDA applicant to file a section viii and then, when appropriate, to resolve owner in the patent declaration and statement, it must ‘‘carve out’’ from the disputes over infringement of those listed in the Orange Book. proposed ANDA labeling, the labeling patents through patent litigation. If The need for accurate and detailed protected by the listed patent. Unless ANDA and 505(b)(2) applicants could information related to the approved the ANDA applicant can show that it is always avoid the possibility of a 30- methods of use claimed in the patent carving out certain method-of-use month stay by asserting in a section viii being submitted for listing is labeling, a section viii statement is not statement that certain labeling for which underscored by the decision in Purepac a correct submission for the listed the applicant is seeking approval is not Pharm. Co. v. Thompson, 238 F. Supp. patent. In Purepac, the court rejected protected by a listed method-of-use 2d 191 (D.D.C. 2002). In that case, the our reliance on the regulations and the patent—despite the NDA holder’s NDA holder submitted information on a general declaration as a reasonable basis assertion to the contrary—there would patent claiming what was later for this approach to implementation. be little reason for any applicant to determined to be an unapproved use of The court specifically pointed to the submit a paragraph IV certification for a the approved drug product. This patent submissions in the case, and method-of-use patent. This approach submission was accompanied by the noted that the NDA holder had not would essentially eliminate the required signed declaration from the complied with the requirement that certification, notice, and litigation NDA holder that the patent covered the NDA holders submit only those patents process as to any listed method-of-use method of use for the approved product. claiming an approved use for the drug. patent, producing an outcome that is Accordingly, we listed the patent and Although the court noted that the facts inconsistent with the act. the use code information submitted in Purepac were unique (the NDA To effectively implement the with the patent. Years later, well after holder later admitted that it made its certification and section viii statement litigation over this patent was submission ‘‘without regard’’ to FDA’s provisions set out in the statute, we underway, the NDA holder clarified to regulations), there may be other cases in must have adequate information FDA that the patent did not, in fact, which NDA holders have submitted concerning method-of-use patents. claim the use for which the NDA was patents claiming unapproved uses of Since 1994, we have requested, but not approved. approved drug products. required, that NDA applicants submit to This submission of inappropriate Following the Purepac decision, we FDA information on the approved use patent information led to confusion and have two options for implementing the claimed by the patent. Since the

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Purepac case and other instances have ministerial role and should review review of the scope of the patent and its raised questions about what aspects of patents to determine if they meet the application to the approved drug the approved drug are claimed by a requirements for listing. Several product. Indeed, the requirement of listed use patent, we believe that it is comments contend that we have the prompt publication (‘‘upon necessary that an NDA holder submit authority to determine the attributes of submission’’), combined with the 30- more specific information on the the approved drug and thus to day timeframe for updating the Orange approved methods of use protected by a determine the appropriate patent Book, are strong evidence that Congress submitted patent. Only with this listings. Various administrative did not intend us to undertake anything information can we determine what mechanisms were suggested through other than a ministerial action. submission is required of the ANDA and which FDA could conduct a review of In addition to the absence of any 505(b)(2) applicants referencing the patents. These suggestions ranged from statutory basis for a substantive agency approved drug. hiring patent lawyers to review review of patents, we have long We further note that we list methods submitted patents to development of a observed that we lack expertise in of use for approved products in the full administrative hearing process. patent matters. An administrative Orange Book in the section on use One comment stated that patent process for reviewing patents, assessing codes. Due to the limitations of our owners need an administrative process patent challenges, and de-listing patents database system and software to enforce the listing of their patents would involve patent law issues that are constraints, we are limited to using 240 because an NDA holder might ‘‘fail’’ to outside both our expertise and our total characters for the use code list eligible patents. authority. Although we will continue to description in the Orange Book. (Response) A fundamental relay questions about the accuracy of a Traditionally, we have created the use assumption of the Hatch-Waxman patent submission to the NDA holder code description for the Orange Book Amendments is that the courts are the (see § 314.53(f)), our patent listing role from the information submitted by the appropriate mechanism for the remains ministerial. Courts have upheld NDA applicant or holder. After resolution of disputes about the scope our determination that our role with considering the comments, and in light and validity of patents. The courts have respect to patent listing is ministerial. of the previously described litigation, the experience, expertise, and authority (See aai Pharma v. Thompson, 296 F.3d we have determined that it is more to address complex and important 227, 242–43 (4th Cir. 2002), cert. efficient and accurate to ask the NDA issues of patent law. This final rule denied, 123 S. Ct. 1582 (2003); holder to give us the exact use code supports that assumption in two ways. American Biosci., Inc. v. Thompson, 269 description to be published in the First, the final rule clarifies what F.3d 1077, 1084 (D.C. Cir. 2001); In re Orange Book. Use codes are intended to patents must and must not be submitted Buspirone Patent Litigation, 185 F. alert ANDA and 505(b)(2) applicants to for listing. This will make it easier for Supp. 2d 363, 371 (S.D.N.Y. 2002); the existence of a patent that claims an NDA applicants and holders and patent Watson Pharm., Inc. v. Henney, 194 F. approved use. They are not meant to owners to avoid inadvertently Supp. 2d 442, 445–446 (D. Md. 2001); substitute for the applicant’s review of submitting patents that do not meet the Mylan Pharm., Inc. v. Thompson, 139 F. the patent and the approved labeling. statutory and regulatory requirements. Supp. 2d 1, 10–11 (D.D.C.), rev’d on We understand that in some cases 240 The clarification will reduce the other grounds, 268 F.3d 1323 (Fed. Cir. characters may not fully describe the pressure on us to intercede in patent 2001).) We recognize that one court has use as claimed in the patent. The listing disputes and will allow the held that parties have no private right of declaration, which includes the courts and parties to focus on the action to seek de-listing of patents (see complete description of the method-of- ultimate issue of patent invalidity or Mylan Pharmaceuticals, Inc. v. use claim and the corresponding non-infringement. Second, the final rule Thompson, 268 F.3d 1323 (Fed. Cir. language in the labeling of the approved requires NDA applicants or holders or 2001)). Nevertheless, it would be drug, will be publicly available after patent owners to submit detailed inappropriate and impractical for us to NDA approval. information and to certify to its create regulatory mechanisms for h. Miscellaneous Patent Listing correctness. This should further ensure reviewing patent listings or permitting Comments. i. Should We Create an that only patents meeting the statutory third parties to submit patents for Administrative Process to Challenge requirements will be submitted for listing. We lack both the resources and Patent Listings or to De-List Patents or listing. the expertise to resolve such matters. to Review the Listability of Patents? The We decline to create an additional Furthermore, even if we were to proposed rule did not propose an administrative process for challenging establish an administrative process for administrative process for challenging patent listings beyond that already patent review, our decisions on these patent listings or for seeking removal of established in § 314.53(f). We also patent listing matters would inevitably a patent from the Orange Book, nor did decline to create a new process for de- lead to disputes and increased litigation we propose a new process to internally listing patents or for internal FDA against us. This litigation could review the patents for listability. review of patents beyond the limited question whether such an (Comment 8) Several comments stated review of the patent declaration administrative process was within our that parties, such as generic drug described in this final rule. Section legal authority. Even if the courts were companies and even third parties, need 505(b)(1) of the act directs NDA to decide that we may review submitted a method for challenging patent listings applicants to submit certain patent patents, there would be repeated or for de-listing patents in the Orange information. It requires that ‘‘[u]pon litigation over individual patent listing Book. Some comments explained that approval of the application, the decisions. Given the uncertainty of the the lack of an administrative procedure Secretary shall publish’’ the patent listing status of the challenged patent for challenging patent listings either information (emphasis added). In during the litigation, there is no encouraged NDA applicants to submit section 505(j)(7)(A)(ii) and (iii) the assurance that, if we reviewed inappropriate patent information, or did statute mandates that we publish submitted patents, ANDAs or 505(b)(2) not deter the practice, to delay generic revisions to this information every 30 applications would be approved sooner competition. A number of comments days. These short time frames do not and generic drugs would enter the maintained that FDA has more than a contemplate a substantive agency market any more rapidly.

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We agree that there have been a few submitted, or whether ANDA or approval but not submitted to us within cases in which legitimate concerns have 505(b)(2) applicants would need to 30 days after issuance. However, the been raised about whether specific provide certifications for patents listed patent will be listed in the Orange Book submitted patents meet the statutory after they had filed an ANDA or upon submission of a complete requirements for submission and listing. 505(b)(2) application. declaration, and ANDA and 505(b)(2) We believe that these concerns will be (Comment 10) Several comments applications filed after the patent is adequately and efficiently addressed by suggested revising the rule to create listed will be required to contain a the clarification of the types of patents time limits relating to the submission of certification to the patent. This that must and must not be submitted patent information or patent longstanding interpretation is consistent and by improvements to the patent certifications. For example, one with the statutory language describing information required. We further believe comment asserted that ‘‘abuse’’ occurs patent submission deadlines, the notice that even if legally permissible, it is not when NDA holders submit non- concept inherent in patent publication, necessary for us to develop a patent meritorious patent information to us and early judicial resolution of patent review mechanism. The final rule shortly before an earlier-submitted disputes. We are not persuaded by the permits us to allocate our limited patent is to expire. Another comment comments that we should change our resources to public health activities, suggested that we limit the time during interpretation. while leaving questions of patent law to which NDA holders can submit patent We believe that removing the the courts, which are better able to information to a defined time period possibility of multiple 30-month stays handle such questions. This division of after we have approved their NDAs. per ANDA will diminish the incentive responsibility is fully consistent with Another comment said we should not to obtain additional patents late in the the process established in the Hatch- require ANDA applicants to submit patent life of the product described in Waxman Amendments. amended patent certifications if the the NDA. As described in the FTC (Comment 9) One comment suggested patent was submitted after the first Report, of the patents reviewed by FTC, that we create an administrative ANDA had been filed. many of the patents submitted well after mechanism to ensure timely patent Similarly, one comment asserted that NDA approval, and usually after an infringement litigation if no statutory a patent submitted after NDA approval ANDA application was filed, were notice is provided to the NDA holder. cannot claim the approved drug product ultimately found to be invalid. (Response) We decline to amend the because the later-submitted patent Therefore, in the absence of the 30- proposed rule as suggested by the would be invalid. The comment month stay, these patents would have comment. The act does not contemplate explained that, under patent law, a been unlikely to serve as a basis for a that we will play an active role in person cannot obtain a patent if the preliminary injunction precluding determining the timing of patent subject of the patent is known and market entry of generic drugs. infringement litigation. In the absence of therefore ‘‘anticipated’’ under patent We also decline to amend the the 45-day timetable imposed when law. notice is given for a paragraph IV (Response) We decline to amend the proposed rule to exempt ANDA certification, a decision on whether and proposed rule as suggested by the applicants from submitting patent when to file suit for patent infringement comments. The act clearly contemplates certifications if the patent was listed may depend on multiple variables. For the submission of additional patent after the ANDA was filed. Our pre- example, did the NDA holder or patent information after an NDA has been filed. existing regulations do not require owner have sufficient information to For example, section 505(b)(1) of the act ANDA applicants to amend their patent instructs applicants to amend their certifications if: decide whether to sue the ANDA or • 505(b)(2) applicant for patent NDAs to include information on a The NDA holder failed to provide infringement? An ANDA applicant and patent issued after the NDA has been the required patent information within the NDA holder may disagree on when filed, but before the NDA has been 30 days after the issuance of the patent; the NDA holder had sufficient approved, which claims the drug or a and • information to decide to file suit. The method of using the drug that is the The ANDA had already been parties may also disagree as to what subject of the application. Section submitted and had contained an constitutes ‘‘timely’’ litigation. For 505(c)(2) of the act directs NDA holders appropriate patent certification before example, an NDA holder who defers to submit patent information if the the submission of new patent filing a lawsuit on a later-filed patent patent issued after we have approved information (see § 314.94(a)(12)(vi)). until a 30-month stay has elapsed may the NDA. We do not interpret the act as However, if the NDA holder has feel that the subsequent litigation is still permitting us to refuse to accept submitted patent information in a ‘‘timely,’’ given the information submissions of new patents either after timely manner, consistent with section available to the NDA holder. The ANDA an NDA has been filed or approved, or 505(c)(2) of the act, then section or 505(b)(2) applicant may view this after an ANDA has been submitted. 505(j)(2)(A)(vii) of the act requires the latter lawsuit as an obstacle to Section 505(c)(2) of the act also ANDA applicant to certify to that marketing its drug product. Given the instructs NDA holders to submit patent. Section 505(j)(2)(A)(vii) of the limits of our statutory authority as well information on patents issued after NDA act requires ANDA applicants to as complex issues of patent litigation approval no later than 30 days after the provide a certification with respect to strategy that lie outside our expertise, date the patent issued. This deadline ‘‘each patent which claims the listed we decline to create a mechanism to ensures prompt public notice that the drug,’’ not only patents that are listed at ensure ‘‘timely’’ patent litigation in NDA holder believes the patent claims the time the ANDA is submitted. The situations where the NDA holder and the approved drug product and permits act contemplates the submission of patent owner did not receive notice of legal issues regarding these later-issued patent certifications even if the patent subsequent paragraph IV certifications. patents to be resolved as early as was listed after the ANDA or 505(b)(2) ii. Should There Be Time Limits on possible. Under § 314.94(a)(12)(vi), we application had been submitted. Patent Submissions or Certifications? do not require an ANDA or 505(b)(2) We do not have the authority to The proposed rule did not specify when applicant with a pending application to declare any patent to be invalid. We patent information would need to be certify to a patent issued after NDA leave questions regarding the issuance

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and validity of patents to the PTO and be asserted***.’’ The number of help to ensure appropriate patent the courts. claims contained within a particular submissions. iii. What Should the Patent patent does not affect the ability of the (2) Should the Declaration Be Declaration Say? (Proposed § 314.53(c)). patent to be listed as long as there is at Expanded or Modified? The proposed Proposed § 314.53(c) would require a least one claim that meets the two rule would revise § 314.53(c)(2) and patent declaration for NDA applicants required elements. would replace the existing, general and holders and patent owners to Individual patent claims are relevant declaration with a more detailed complete as part of the NDA, an for purposes of the Orange Book only in declaration. The proposed declaration amendment, a supplement, or for the context of method-of-use patents. would be a ‘‘checklist’’ that required information on a later-issued patent. The specific method-of-use claims are information on the approved drug The proposed revised declaration in the essential to our review because sections product including trade name, active proposal was a ‘‘checklist’’ that focused 505(j)(2)(A)(viii) and 505(b)(2)(B) of the ingredient(s), strength(s), dosage on individual patent claims. The act allow ANDA and 505(b)(2) form(s), and approval date. For each proposed declaration required applicants to file statements which patent submitted, each claim of a patent information on each claim to help assert that the method-of-use patent which applied to the drug substance ensure that applicants submit only does not claim a use for which the (active ingredient), drug product appropriate patent information, and that applicant is seeking approval. The (formulation or composition), and they stand behind the accuracy of the ANDA or 505(b)(2) applicant does not method of use would need information. The proposed requirement have to seek approval for all uses identification. A ‘‘yes’’ or ‘‘no’’ check- to identify claims was intended to help approved for the reference listed drug. off would be required as to each all parties focus on the same claim and Thus, the claim-by-claim listing of individual applicable patent claim. The help prevent arguments as to whether a method-of-use patents will permit proposed § 314.53 would require the particular claim claimed the approved ANDA and 505(b)(2) applicants to NDA applicant or holder or patent drug product. assess whether they are seeking owner to state in the declaration that the (1) Should the Declaration Identify approval for a use claimed in the listed information was provided for an NDA Individual Patent Claims? patent, and thus determine whether to submitted under section 505 of the act. (Comment 11) Several comments submit a patent certification or a section (Comment 12) Several comments objected to identifying patent claims as viii statement. Additionally, we can supported our proposed changes to the part of the declaration. The comments verify that the certification or statement declaration but also suggested additions stated that a claim-by-claim listing: is correct, and that only the appropriate to the declaration. These comments • Would be ‘‘unnecessarily onerous’’ methods of use are included in the would add the following information to because patents may contain many proposed labeling for the ANDA or the declaration: claims; • 505(b)(2) drug product. Specific exclusions of patents for • Could threaten the patent holder’s forms of the active ingredient not We decline to adopt the legitimate rights if the NDA applicant marketed, such as acids, freebases, salts, recommendation made in some failed to list a patent claim because the and isomers; failure to list that claim could be used comments to require all claims to be • Exclusion of patents claiming as an admission against the NDA listed and then provide a 30-month stay labeling matters such as business holder’s or patent owner’s interests in only for litigation involving a claim methods, registries, titration/dosing litigation; listed in the Orange Book. This schedules, or ornamental designs; • Could expose the NDA holder to suggestion would require us to • Exclusion of a patent claiming a criminal and civil liability if the claim significantly exceed our ministerial drug substance claimed in conjunction cited in the declaration is later found responsibility in listing patents because with another active ingredient or not to claim the drug; or, we would be obliged to evaluate patent method of using the combination which • Is irrelevant to patent listing because lawsuits and their relation to individual is not the claimed drug substance; the patent, and not the patent claims, is patent claims. We discuss our • Various forms of statements what we must list in the Orange Book. ministerial role in the response to indicating or certifying the submitter Other comments supported the claim- comment 8. Removing the proposed has filed accurate information; by-claim listing. Some comments requirement of a claim-by-claim listing • Identification of the NDA requested that we impose a 30-month in the final rule should not be applicant’s pending patent applications; stay only if the specific claims detrimental to ANDA or 505(b)(2) and submitted in the patent declaration were applicants. In fact, several generic • Additional information for product- the subject of the patent litigation filed companies, the FTC and the Generic by-process patents. within the 45-day time period. Pharmaceutical Association (GPhA), The comments suggested that it was (Response) We have re-examined our stated in their comments that no necessary to identify each of the rationale for proposing a claim-by-claim ‘‘prudent generic company’’ would rely excluded patents in the declaration form listing and have concluded that solely on Orange Book listings to and the codified text. Several comments submission of a claim-by-claim evaluate patent information for suggested requiring a sworn statement declaration for all patents is not litigation exposure, particularly when and an acknowledgement that a false warranted. Such detailed information is all patents cannot be listed in the statement was subject to criminal not explicitly required by the act and is Orange Book. Thus, we believe that penalties. For example, one comment not necessary for a patent to be listed in identification of the relevant patent(s), suggested that the declaration include the Orange Book. Section 505(b)(1) of as opposed to the individual patent the statement: ‘‘The undersigned the act requires that the patent be one claims (other than for method-of-use declares that all of the above that ‘‘claims the drug for which the patents), satisfies the act’s explicit information has been provided in applicant submitted the application or requirements, provides sufficient accordance with Title 28, section 1746, which claims a method of using such information to potential applicants to entitled ‘Unsworn declarations under drug and with respect to which a claim determine if a more thorough patent penalty of perjury’,’’ followed by the of patent infringement could reasonably search or analysis is warranted, and will signature, date, title, and telephone

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number. The comment also would attested to as to the accuracy of the ‘‘same’’ as the active ingredient require additional information on patent information being submitted. approved in the NDA. We require patents in the declaration form to Examples of the two declaration forms, information on whether the patents identify that the product in the product- FDA Form 3542 and 3542a, are submitted claim metabolites or by-process patent was a novel product. provided in the Appendix found at the intermediates to help ensure that the (Response) We agree, in part, with the end of this document. The declaration patents prohibited from submission comments that the information that forms will be available on the Internet under final § 314.53(b) are not would be required in the declaration at http://www.fda.gov by searching for submitted. Similarly, we require should be modified. Also, we have the word ‘‘forms’’. information on patents claiming the created standardized declaration forms The final rule also revises pre-existing drug product to prevent the submission which will encompass the required § 314.53(c)(2)(ii) and (c)(3) to conform to of patents claiming packaging. patent declaration information. the changes we made to the patent The final rule also requires The final rule changes the general information required on the declaration information on product-by-process requirements in pre-existing forms. The final rule requires a patents as discussed in the response to § 314.53(c)(1) by requiring that the declaration form to be filed with us comment 2 of section II.A of this patent information which must be within 30 days after NDA approval; this document. We have added a submitted must be provided on the is consistent with the pre-existing requirement that the NDA applicant or declaration forms in full. In final requirement. This form must also be holder or patent owner state whether § 314.53(c)(2), we substitute declaration used to file patent information on any the patent being submitted is a product- forms which must be used in place of patents submitted or issued after NDA by-process patent in which the product the checklist described in the proposed approval. This declaration form requires claimed is novel. This is to help ensure rule. Each declaration form is a standard the NDA holder or patent owner to that process patents are not submitted form that must be used by all NDA provide the patent information for listing. applicants or holders or patent owners applicable to the approved NDA. It is We agree that the attestation in the for submission of patent information at similar to the declaration form filed declaration form should be revised in the time of initial NDA or supplement upon the filing of an NDA, supplement, the final rule. In the proposal, we stated filing, and upon and after NDA or or amendment. However, the that we had revised the declaration so supplement approval. declaration form filed upon or after that applicants would ‘‘make careful For several years our Internet Web site NDA approval requires information on and well-considered representations’’ has included a sample format which can the approved product and a description and ‘‘stand behind the accuracy of that be used in submitting patent of the approved methods of use for the information’’ (see 67 FR 65448 at information required under pre-existing use code listing in the Orange Book. 65453). In the final rule, we revise the regulations. Although use of the sample This description will be limited to 240 statement to be more specific about the format is purely voluntary, it is used characters as discussed in the response need to ensure the information is extensively to submit patent to comment 7. accurate. We adopt the attestation information to us. Based on this The final rule describes other statement contained in 28 U.S.C. 1746 experience, and given the additional information required for the declaration for unsworn declarations and include information required in the final rule, forms not identified in the proposed attestations in the declaration forms. we concluded that mandatory rule. Some of the additional information The attestation statements in the declaration forms are appropriate to will allow us to more easily determine declaration forms read as follows: obtain the patent information. We, thus, the eligibility of the patent for listing, (Declaration Form 3542a submitted with require use of forms in the final rule. while other information will provide NDA, amendment or supplement.) Since we determined that forms are more complete information related to The undersigned declares that this is an appropriate, we have consolidated the responsibilities of the NDA holders accurate and complete submission of patent information currently required by pre- information for the NDA, amendment, or or ANDA applicants. For example, we supplement pending under section 505 of the existing regulations with the new require the issue date of the patent in Federal Food, Drug, and Cosmetic Act. This required information. For example, we order to determine whether the patent time-sensitive patent information is require a response on whether there are has been submitted to us within the submitted pursuant to 21 CFR 314.53. I attest relevant patents related to the drug required 30 days. We require that I am familiar with 21 CFR 314.53 and product, information currently required information on whether the patent being this submission complies with the under pre-existing § 314.53(c)(3). This submitted has been submitted requirements of the regulation. I verify under was not contained in the proposal but, previously for the NDA or supplement penalty of perjury that the foregoing is true for administrative efficiency, and to and correct. referenced in the declaration. For (Declaration Form 3542 submitted upon or lessen the burden on NDA applicants or example, an earlier listed patent may after NDA approval.) holders or patent owners, we have have included several method-of-use The undersigned declares that this is an included in the declaration forms all of claims but only one method of use accurate and complete submission of patent the required information relating to the previously approved and submitted. A information for the NDA or supplement patent submission. second method of use may be approved approved under section 505 of the Federal The NDA applicant must provide a in a supplement and must be submitted Food, Drug, and Cosmetic Act. This time- declaration form when an NDA, for listing. Such information will assist sensitive patent information is submitted amendment, or supplement to an NDA pursuant to 21 CFR 314.53. I attest that I am the Orange Book staff with its familiar with 21 CFR 314.53 and this is filed. The NDA holder must also administrative listing responsibilities. submission complies with the requirements submit another declaration form after The address and contact information of of the regulation. I verify under penalty of NDA or supplement approval to provide the patent owner required in the perjury that the foregoing is true and correct. information on all patents relevant to declaration forms will assist in the We also include a warning statement in the approved NDA or supplement, required notification to the patent the declaration forms to alert the whether or not information on any such owner of a paragraph IV certification. submitter that a willfully and knowingly patent was previously submitted. The We have elaborated on the requirement false statement is a criminal offense declaration forms filed with us must be for asserting that the polymorph is the under 18 U.S.C. 1001.

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We decline to revise the proposed NDA supplements, or newly issued calendar days of the notification, we rule to list every excluded type of patent patents will not be published in the will consider the patent information to as requested by some comments. Based Orange Book unless and until we have been submitted as of the date we on our experience, we believe that if we receive a complete declaration originally received it, that is, within the attempted to include questions on all submitted post-NDA approval 30 day period allowed by the statute. If types of patents, such as ‘‘business indicating the patent is eligible for the NDA holder submits the adequate method’’ or ‘‘registry’’ patents, or listing. declaration more than 15 calendar days specifically list all exclusions in the We interpret the statute to permit after notification, we will consider the final rule, there would be disagreements listing of only those patents claiming patent information to have been over whether the examples are all- the approved drug product and its submitted on the day the revised inclusive or whether other types of approved uses. Even though the NDA declaration form is received, which may patents were excluded as well. We applicant must submit patent be more than 30 days after the date of believe the patent information requested information prior to NDA approval, it is patent issuance. Such patents will be not until the NDA or supplement has is sufficient to ensure only eligible subject to patent certification only as been approved that the scope of that patents are submitted for listing. described in § 314.94(a)(12)(vi). If the We also decline to revise the approval is known. For example, we NDA holder does not submit an declaration to require identification of might approve only one of two an NDA applicant or NDA holder’s indications proposed in an NDA and, adequate declaration for the newly patent applications that are under thus, patents on an unapproved issued patent, we will not list the patent review by the PTO. The act does not indication or use, although submitted in the Orange Book. This approach is contain any references to pending with the original NDA, could not be appropriate because it gives the NDA patents. In contrast, sections 505(b) and listed. Therefore, as a way of confirming holder who promptly submits 505(c)(2) of the act contain requirements or amending the original patent information on a newly-issued patent a for patent information to be submitted information, a declaration form must be reasonable period of time to correct a after the patent is issued. Section 505(b) submitted after approval. If the mistake in a patent declaration, while at of the act requires that the information declaration form submitted after NDA the same time ensuring that there are submitted on any patent claiming the approval is incomplete or indicates a adequate declarations and minimal drug include the patent number and patent is not eligible for listing, we will delays for listed patents. We will accept expiration date of the patent. We notify the NDA holder and indicate the certifications to any patent only from publish that information when we list reason. The NDA holder must resubmit the date an acceptable declaration is the patent in the Orange Book. A patent the declaration form with complete submitted. number and expiration date are information indicating that the patent is The process established in § 314.53(f) available only when the PTO issues a eligible for listing. If the declaration for patent listing challenges is not patent and are not available for pending form is incomplete or indicates the altered by our requirements for patent patent applications. Accordingly, we patent is not eligible for listing, we will information and declaration forms. will not require submission of refuse to list the patent until an Interested parties may still rely on that information regarding pending patent appropriate declaration form has been process if they believe a patent has been applications. submitted. submitted and listed in error. Although we do not require For patents newly issued by the PTO submission of information concerning after the NDA is approved, section We are aware of NDA holders that pending patent applications, we 505(c)(2) of the act requires that the have submitted patents for listing that understand that pending patent NDA holder submit the patent have been listed in the Orange Book and applications are generally publicly information to us within 30 days to be then, at a later time, been removed from disclosable by the PTO if pending for considered timely filed. All such patent the Orange Book at the NDA holder’s more than 18 months at the PTO or information must be contained in a request. If, after the patent has been foreign patent offices. In addition, complete declaration submitted post- removed from the Orange Book, the information concerning pending patents NDA approval indicating that the patent NDA holder again seeks to submit the would not provide any useful is eligible for listing. A patent is patent for listing, we will require information if the PTO never issued the considered listed in the Orange Book as resubmission of the patent information patent. of the date it is received in the Central and the filing of an accompanying We note that we will not evaluate a Document Room as required in patent declaration before the patent will patent to assess whether the declaration § 314.53(d)(4) and (d)(5), if it is be relisted. Such resubmission will be is accurate or whether the patent has accompanied by a declaration form that governed under the final rule. If the been appropriately submitted for listing is both complete and contains resubmission of a previously listed (see our response to comment 8). We information indicating that the patent is patent takes place after the effective date will, however, review the declaration eligible for listing. If we must notify an of this rule, the final rule applies as for completeness and to determine that NDA holder that a declaration form is described in section IV of this the information given by the NDA incomplete or the patent is not eligible document. applicant or holder or patent owner for listing, and the NDA holder then indicates that the patent is eligible for submits an acceptable declaration The final rule does not require us to listing. within 15 calendar days, we will review or evaluate patents, but will Although section 505(b)(1) of the act consider the patent timely filed. So, for simplify and clarify the submission requires submission of patent example, suppose an NDA holder process for NDA applicants and holders information upon the filing of an NDA, submits information on a new patent to and patent owners, and will promote we will rely only on the declaration us 20 days after the patent is issued by administrative efficiency. The form filed upon or after NDA approval PTO, and we notify the NDA holder 5 additional information required by the under § 314.53(c)(2)(ii) to list patent days later that the declaration is declaration form will help ensure that information in the Orange Book. Patent incomplete. If the NDA holder submits only appropriate patents are submitted information for newly approved NDAs, an adequate declaration within 15 for listing.

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2. How Many Times Can an ANDA or • Require us to notify the NDA holder reasons other than the listing of a patent § 505(b)(2) Application’s Approval Date as to a subsequent paragraph IV subsequent to the filing of an ANDA. Be Delayed by 30-Month Stays? certification. (Response) We decline to modify the Similarly, several comments proposed rule as suggested. We The proposed rule offered an expressed concerns that ANDA and conclude, however, that clarification of interpretation of the act that would limit 505(b)(2) applicants could manipulate the proposed rule is required in the final the number of 30-month stays to only the rule to avoid even a single 30-month rule to ensure that our revised one possible stay per ANDA or 505(b)(2) stay. The comments explained that in interpretation allows for one full application. The proposed the absence of notice for all paragraph opportunity for a 30-month stay after interpretation in the proposed rule IV certifications, there could be several notice of a paragraph IV certification. differed from our previous scenarios in which an ANDA or Our long experience with interpretation of the act (which allowed 505(b)(2) applicant could take advantage administering the Hatch-Waxman for multiple 30-month stays). Under our of the regulations to avoid a meaningful Amendments convinces us that any proposed interpretation, the ANDA or 30-month stay under our revised regulatory scheme in this area will be 505(b)(2) applicant would continue to interpretation. For example, an ANDA complex, and that any advantage that a file the appropriate certifications as or 505(b)(2) applicant could file a party can find in manipulating the required under section paragraph IV certification on a narrow regulatory program will be pursued. 505(j)(2)(A)(vii)(I) through patent or a narrow patent claim and Despite our conviction that the final (j)(2)(A)(vii)(IV) or section provide notice to the NDA holder and rule will substantially reduce such 505(b)(2)(A)(i) through (b)(2)(A)(iv) of patent owner on that certification, manipulation, we do not believe we can the act. However, under the proposed thereby satisfying the regulatory completely prevent attempts at ‘‘creative compliance’’ by the parties. interpretation in the proposed rule, the requirements, while providing a Our revised interpretation of the notice to the NDA holder and patent paragraph III certification on broader holder of the paragraph IV certification statute reads all three subparagraphs of patents or claims. The NDA holder or section 505(j)(2)(B) of the act as a is required only when a paragraph IV patent owner could bring a patent certification is included in the initial coherent whole. We believe that infringement suit within the 45 days, Congress considered the first paragraph ANDA or 505(b)(2) application or when triggering a 30-month stay, or decide not such an application is amended to IV certification, notice and the to bring suit on the narrow claim or opportunity for a single 30-month stay, include, for the first time, a paragraph patent. The comments argued that, after IV certification. Notice to the NDA to be part of an inter-connected process. suit was filed, or after the 45 days In the final rule we keep these holder and patent owner is one of the expired with no suit initiated, the requirements for a 30-month stay; if the provisions operating together, as much ANDA or 505(b)(2) applicant could as possible, requiring that certifications ANDA or 505(b)(2) applicant is not change the paragraph IV certification to be made and notification provided in obliged to provide a subsequent notice a paragraph III. If suit had been filed, such a way that there always will be one to the patent owner and NDA holder, no the applicant could seek dismissal of full opportunity for a 30-month stay. successive 30-month stay is possible. the patent infringement suit and avoid The notice requirement in the final a. When Must Notice Be Provided and the 30-month stay. At a later date, the rule depends on whether the ANDA or What Is a Full Opportunity for a 30- ANDA or 505(b)(2) applicant could 505(b)(2) application contained a Month Stay? The proposed rule would change its paragraph III certification on paragraph IV certification before the require an ANDA or 505(b)(2) applicant the broader patent or claim to a submission of an amendment containing to provide notice to NDA holders and paragraph IV certification, but because a paragraph IV certification. We note patent owners only when the applicant there had already been an opportunity three potentially confusing situations files a paragraph IV certification with for a 30-month stay, no further 30- concerning applicability of that the initial application or amends the month stay would be possible. principle and describe how these will application to include a paragraph IV The comments maintained that we be treated under the final rule. certification for the first time. If the should not allow such manipulation First, an ANDA or 505(b)(2) applicant application were amended to add and that it could be avoided by treating who filed a paragraph IV certification additional paragraph IV certifications, the new or revised certification as could change to a paragraph III no notice to the NDA holder and patent though it relates back to, and substitutes certification after notice is given but owner would be required. for, the original certification so that the before the 45 days for filing suit has run (Comment 13) Several comments notification requirements for original and before a suit is filed. In this claimed that the lack of notice for applications, and not those for situation, because the opportunity for a subsequent paragraph IV certifications amendments, apply. Under this 30-month stay has not vested (the 45 would delay initiation of patent suggested approach, the changed days has not expired or patent litigation litigation. To avoid this ‘‘delay,’’ the paragraph III certification would be has not yet been initiated), under the comments suggested that, if we retained treated as if the original application had final rule, this ANDA or 505(b)(2) our proposed interpretation allowing contained the paragraph IV certification. application will not be considered to only one 30-month stay per ANDA or The new certification, thus, would have ever included a paragraph IV 505(b)(2) application, we should amend require notice to the NDA holder and certification. If a paragraph IV the rule to: patent owner and have the potential to certification is submitted later, the trigger a 30-month stay. The comment notice obligation and one full • Give the ANDA applicant the cited § 314.94(a)(12)(viii) which relates opportunity for a 30-month stay will ‘‘option’’ to provide voluntary to amended certifications to support this attach. This ensures that, consistent notification; approach. In this instance, it was argued with the statute, for at least one • Give the ANDA applicant the that there should be the opportunity for paragraph IV certification, the NDA ‘‘option’’ to provide notification and be at least one 30-month stay when the holder or patent owner has a full 45 subject to an ‘‘optional’’ additional 30- ANDA or 505(b)(2) applicant ‘‘alters or days to determine whether to exercise month stay; amends’’ a patent certification for the right to sue for patent infringement

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and to obtain a 30-month stay on ANDA The third situation could occur when application will be considered to have or 505(b)(2) approval. The phrase ‘‘one an applicant withdraws an ANDA or contained only the changed certification full opportunity for a 30-month stay’’ 505(b)(2) application that contained a retroactively to the date that the original used throughout this preamble means a paragraph IV certification after it has certification was filed. If interpreted in notice of a paragraph IV certification provided notification to the NDA holder that manner, an ANDA or 505(b)(2) followed by either the full 45 day and patent owner. If an ANDA or applicant could amend certifications to period, or notice followed by the 505(b)(2) applicant were to reactivate its other patents and make them paragraph initiation of patent litigation before the withdrawn application, it might IV certifications. Among other 45 days expire. contend that the notice that it provided difficulties, an applicant could then Only where both the 45 days have not prior to withdrawal of the ANDA or argue that, by virtue of relating back, run and the ANDA or 505(b)(2) 505(b)(2) application was the only such a paragraph IV certification was applicant has not been sued for patent notice that could trigger a 30-month the ‘‘first’’ application with a paragraph infringement will this exception apply. stay, regardless of whether the 45 day IV certification, potentially entitling the If the NDA holder brings suit before the period had run, whether patent applicant to exclusivity under section 45 days, and the ANDA or 505(b)(2) infringement litigation was initiated, or 505(j)(5)(B)(iv) of the act. This theory applicant then changes its application to whether that litigation was terminated would lead to absurd results in the omit any paragraph IV certifications, the because of withdrawal of the application of 180-day exclusivity. court where suit is pending can application. Furthermore, we note that ANDA determine how to proceed. Our pre-existing regulations prevent applicants have substantial incentives to For effective enforcement of this an applicant from using withdrawal to avoid manipulation of the patent provision of the regulations, notice of defeat the opportunity for one 30-month certification process. The 180-day the first paragraph IV certification(s) stay. Under §§ 314.52(b) and 314.95(b), marketing exclusivity provided in must be given by the ANDA or 505(b)(2) the applicant is not to give notice until section 505(j)(5)(B)(iv) of the act is a applicant either: (1) When the applicant it receives an acknowledgement letter significant incentive for ANDA from us stating that its application is applicants to file legitimate paragraph receives from us an acknowledgement sufficiently complete to permit review. IV certifications. Exclusivity as to each that the ANDA or 505(b)(2) application Any notice sent prior to receipt of such listed patent is available only to the first is sufficiently complete to permit letter will not constitute the notice that ANDA applicant filing a paragraph IV substantive review, or (2) at the same creates the full opportunity for the certification. Frequently, there is a race time that the amendment to the ANDA single 30-month stay. to submit the first paragraph IV or 505(b)(2) application is submitted to Once the review period begins, an certification. Consequently, given this us. These requirements are already application may not be withdrawn and incentive, we do not anticipate that contained in our regulations at then ‘‘reactivated.’’ If the ANDA or ANDA applicants will manipulate their § 314.95(b) and (d) and § 314.52(b) and 505(b)(2) application is withdrawn patent certification filings, because they (d). (These also apply to a second notice during the review period, we ‘‘will treat could jeopardize their chances of of a paragraph IV certification when the the resubmission as a new application obtaining the valuable 180-day first notice did not result in a full or abbreviated application’’ under exclusivity. opportunity for a 30-month stay.) The § 314.100(b). If the applicant wishes to We encourage ANDA and 505(b)(2) importance of ANDA and 505(b)(2) have the withdrawn ANDA or 505(b)(2) applicants to resolve their concerns applicants providing this notice was application reviewed, it must submit it about commencing litigation quickly by recently reaffirmed in TorPharm, Inc. v. as a new ANDA or 505(b)(2) application. providing voluntary notice to the NDA Thompson, Civ. No. 03–0254 (D.D.C. The ‘‘decision to withdraw the holder and patent owner as they wish. April 25, 2003) (appeal pending). ANDA application is without prejudice to There is nothing in the final rule to and 505(b)(2) applicants shall submit refiling’’ as noted in § 314.65. However, prevent ANDA or 505(b)(2) applicants proper documentation of notice to us as we will treat the new ANDA or 505(b)(2) from providing notice on their own required by §§ 314.95(e) and 314.52(e). application in the same manner as any initiative, nothing to prevent NDA Second, an applicant who filed a other original application. The applicant holders or patent owners from paragraph IV certification with its will be required to provide notice for responding with patent litigation, and original ANDA or 505(b)(2) application paragraph IV certifications contained in nothing to prevent ANDA or 505(b)(2) could change its paragraph IV the new ANDA or 505(b)(2) application, applicants from not marketing during certification (generally to a paragraph III with the possibility of a single 30-month the litigation. To the extent that ANDA certification) after a patent infringement stay. If the new ANDA or 505(b)(2) or 505(b)(2) applicants seek resolution suit is filed and after the 30-month stay application contains no paragraph IV of outstanding patent issues before has commenced. Such a change could certification, notice must be provided if entering the market, we note that the occur, for example, as a result of a court it is later amended to include such a applicant can file a declaratory order after a finding of infringement in certification. In short, withdrawal of an judgment action (as discussed below) the patent litigation. In this ANDA or 505(b)(2) application will not and enter into a stipulated preliminary circumstance, an application that defeat the opportunity for a 30-month injunction pursuant to which the ANDA previously contained a paragraph IV stay of approval for the resubmitted or 505(b)(2) applicant will not enter the certification would no longer do so. If ANDA or 505(b)(2) application. market during the course of the such an application is subsequently We do not agree that litigation. Such a stipulation, of course, amended to add a new paragraph IV § 314.94(a)(12)(viii) supports a ‘‘relation must be consistent with FTC precedent certification, the notice obligation will back’’ theory. The provision does and established antitrust requirements. not be triggered for the new provide that when an ANDA or Information on pertinent FTC consent certification. The notice requirement 505(b)(2) applicant changes a orders may be obtained from the FTC or and one full opportunity for 30-month certification in its application, ‘‘the its Internet Web site. stay will have been exhausted when the application will no longer be considered The interpretation we are adopting in first patent lawsuit was filed and a 30- to contain the prior certification,’’ but it the final rule allows only one 30-month month stay was imposed. cannot be read to suggest that the stay per ANDA or 505(b)(2) application;

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it does not permit multiple 30-month full opportunity did not result. Only the submitted both by brand name or stays. Revising the rule to impose paragraph IV certifications for which innovator firms and their trade additional 30-month stays would be notice is required will be routinely associations and by generic drug firms contrary to our interpretation of the act subject to public disclosure prior to or related interests. We believe such and the reasons for the rulemaking. approval. All other certifications in an mutual interests will encourage the Furthermore, requiring notice and application would be considered voluntary disclosure of paragraph IV imposing a second full opportunity for confidential, commercial information. certifications. an additional 30-month stay under the Unless the ANDA or 505(b)(2) applicant (Comment 15) Several comments circumstances described would be makes the subsequent certification responded to our request for comments inconsistent with our legal basis for a public on its own accord, we are on whether our regulations concerning single 30-month stay since we permit prohibited from any disclosure that the certifications filed by ANDA and notice and one full opportunity for a 30- would reveal the applicant’s identity, 505(b)(2) applicants and the notice to month stay per ANDA or 505(b) contents of the application, or the NDA holders and patent owners could application. Multiple 30-month stays timing of the application (see or should be modified. Most comments increase the delay in approval of generic §§ 20.61(b) and 314.430). We do not agreed that we had the authority to drugs and result in increased costs to believe that amending our FOIA modify both the certifications and the consumers because the cost of regulations to permit the release of notice. One comment suggested that we individual drugs is reduced when information typically considered ‘‘clarify the elements of a proper generic drugs enter the marketplace and confidential, commercial information, paragraph IV notification’’ to ‘‘ensure compete with the NDA drug. i.e. information that could cause that paragraph IV notifications b. Should All Paragraph IV competitive harm is appropriate, communicate meaningful information Certifications Be Made Public and without deciding at this time that we regarding the basis for an assertion that Should the Notice Requirements Be could even do so. a listed patent is invalid or not Modified? The proposed rule would Although parties are free to make infringed’’ and that ‘‘adequate’’ limit when a notice of a paragraph IV paragraph IV certifications public information is provided. Another certification is provided to NDA holders themselves, we will continue to adhere comment suggested that the notice and patent owners but did not address to our pre-existing FOIA and public provided to the NDA holder and patent the content or format of the notice. The disclosure requirements as applicable to owner of a paragraph IV certification proposed rule did not address whether paragraph IV certifications. We also should include an explanation of the or not paragraph IV certifications were intend to publish on our Internet Web relationship between the patent claims subject to public disclosure. We invited site, for each drug, the number of as construed by the ANDA or 505(b)(2) comment on whether our regulations paragraph IV certifications filed to applicant and the drug product. Another regarding the notice by ANDA and patents submitted after the effective date comment said we should require the 505(b)(2) applicants to the NDA holder of this final rule, if it can be done in a NDA holder and patent owner to and patent owner could and should be manner that is consistent with FOIA. To identify an ‘‘agent for service’’ and amended (67 FR 65454). avoid any inappropriate public require service by registered mail to (Comment 14) Several comments identification, we will not publish the ensure that the notice will reach its suggested that we should post all number of subsequent paragraph IV ‘‘proper location within the corporation paragraph IV certifications on our Web certifications if there is only one ANDA in a timely manner.’’ site because, these comments argued, or 505(b)(2) application containing a (Response) In reviewing the current there is no basis to exempt the paragraph IV certification because such notification requirements at § 314.95(c), paragraph IV certifications from public publication would be tantamount to a we do not believe that the suggested disclosure. The comments also public disclosure of that applicant’s solutions for clarification or more suggested that we disclose all paragraph confidential, commercial information. detailed explanations would improve IV certifications. The NDA holder and patent owner upon the current regulation. The current (Response) We decline to amend the also have other means to determine regulation requires specific information proposed rule to make public all whether subsequent paragraph IV in a notice that explains in full, and in paragraph IV certifications or otherwise certifications have been filed. If a detail, the nature of the claim that the provide notice of paragraph IV lawsuit is filed after notice of the listed patent is invalid or, unenforceable certifications to NDA holders and patent paragraph IV certification, the NDA or will not be infringed. Our regulations, owners. Under current practice, holder or patent owner can use the at §§ 314.52(a) and 314.95(a), require paragraph IV certifications are subject to litigation process to discover the ANDA notification by registered or certified public disclosure under the Freedom of or 505(b)(2) applicant’s certifications to mail, return receipt requested. Our Information Act (FOIA) and FDA’s subsequent patents. Furthermore, regulations also require documentation public disclosure regulations once the additional public information is of a receipt establishing that the notice notice of the paragraph IV certification available if we issue a tentative approval was received by the listed NDA holder has been provided to the NDA holder letter to the ANDA or 505(b)(2) and patent owner (see § 314.52(e) and and patent owner. Because the notice to applicant with a paragraph IV § 314.95(e)). A receipt other than a the NDA holder or patent owner of the certification. These letters are publicly return receipt or a letter from the paragraph IV certification is considered available before the ANDA or 505(b)(2) recipient acknowledging receipt can be a public disclosure after notice has been applicant receives an approval and note provided only with advance FDA given, the certification is available the applicable patents, patent agreement. under FOIA. The final rule requires certifications, and exclusivities affecting We do not believe it would be notice only for the first paragraph IV the timing of the approval of the ANDA appropriate to further limit delivery of certification of an ANDA or 505(b)(2) or 505(b)(2) application. the notice, nor do we believe it is application if that notice results in a full We note that comments concerning appropriate to require ‘‘agents for opportunity for a 30-month stay. Notice public disclosure of paragraph IV service.’’ We are not persuaded that for a subsequent paragraph IV certifications and the need for quick such agents would solve the comment’s certification will be required only if the resolution of patent issues were problem that ‘‘notice is not reaching its

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proper location within the corporation (Response) We decline to adopt the reduce ‘‘certainty’’ for ANDA in a timely manner.’’ In addition, the additional limitations as suggested by applicants. individual listed as the ‘‘agent for the comments. The act requires a (Response) We appreciate the desire service’’ could change, resulting in certification for each listed patent for to resolve patent issues quickly, but confusion and delay in providing each application filed under sections believe the concerns expressed about notice. 505(b)(2) or 505(j) of the act. We the ability to pursue declaratory (Comment 16) Another comment construe section 505(c)(2) of the act to judgment actions are unwarranted. suggested we require ANDA and require submission of patent Section 505(j)(5)(B)(iii) of the act 505(b)(2) applicants to file a new information after NDA approval, provides: ‘‘Until the expiration of forty- complete application for every drug without regard to when an ANDA or 505 five days from the date the notice made product listed separately in the Orange (b)(2) application has been filed. We under paragraph (2)(B)(i) is received, no Book rather than allow applicants to file decline to limit the 30-month stay action may be brought under section supplements to approved applications. resulting from a paragraph IV 2201 of title 28, United States Code, for This comment would require new certification to only those patents a declaratory judgment with respect to applications for each drug strength submitted before any ANDA or 505(b)(2) the patent.’’ We interpret this particular listed in the Orange Book as a separate filing, or those filed only within 30 days section as creating an exception to the product. of NDA approval, or per listed drug general right of a party to bring a (Response) We decline to adopt the instead of per application. declaratory judgment action at any time comment’s suggestions. Our current d. Will the Application of Only One that jurisdictional requirements are policies regarding supplements to 30-Month Stay Affect Declaratory satisfied under title 28, United States ANDA and 505(b)(2) applications allow Judgment Actions Under the Act? Code. The general rule allowing declaratory judgments under 28 U.S.C. for significant administrative (Comment 18) Several comments 2201 would be applicable as long as a efficiencies and reduced application supported the single 30-month stay but party can satisfy the ‘‘case or review times. Requiring separate ANDA expressed concern that limiting the controversy’’ requirement that is or 505(b)(2) applications would notice requirement and 30-month stays necessary to file a declaratory judgment substantially increase costs for to the first paragraph IV certification action. The exception created in section applicants, as well as the agency, to could affect the ability of ANDA and accommodate the burden of creating, 505(j) of the act restricts the timing 505(b)(2) applicants to file a declaratory when a declaratory judgment action submitting, processing, and reviewing judgment action to resolve patent multiple, complete applications. Our may be filed under certain limited infringement issues. Some comments circumstances. Under the act, if notice policy regarding supplemental ANDAs believed that in the absence of both for multiple strengths of a drug has been of a paragraph IV certification is notice to the NDA holder and patent required, no declaratory judgment a major factor in reducing ANDA review owner and the ensuing 45-day period action can be filed until 45 days after times. Before 1991 (when applicants within which a patent infringement suit that notice is given to the NDA holder had to submit separate ANDAs for could be initiated, a declaratory and patent owner. However, if no notice different strengths of a drug), the judgment action could not be brought. is required to be provided to the NDA median approval time for an ANDA was Other comments opposed the single 30- holder and patent owner, the exception 33 months. Today it is approximately 18 month stay and also expressed concern created in section 505(j) of the act no months. A key purpose of this final rule about the ability to pursue a declaratory longer applies, and the general rule is to help expedite the approval of judgment action under the proposal. permitting declaratory judgments to be generic products so that they can more Some comments questioned whether a filed at any time under 28 U.S.C. 2201 quickly be introduced to the declaratory judgment action could be would apply. marketplace. If we adopted the filed under other statutory provisions; We also disagree with the conclusions suggestion, the probable effect would be the comments explained that the Hatch- drawn from the cases cited in the to delay the introduction of generic Waxman Amendments created the act of comments that, in the absence of the drugs into the market because the patent infringement and, if litigation notice of subsequent paragraph IV review times would increase. Requiring were bought ‘‘outside’’ the act, there certifications, there would be no case or multiple applications would not would be no ‘‘case or controversy’’ controversy on which to base a provide any additional value to our required by those provisions. One declaratory judgment action. A case or review of ANDA applications. comment cited Cordis Corp. v. controversy can exist where first, there Consequently, we decline to require Medtronic, Inc., 835 F.2d 859, 862 (Fed. is reasonable fear of a lawsuit and, separate applications as suggested by Cir. 1987), noting that ‘‘when the second, the plaintiff has actually the comment. generic cannot meet the subjective produced the product in question or is c. Should the Single 30-Month Stay Be standard of proving a reasonable prepared to produce the product. (See Further Limited? apprehension of a suit by the brand Cordis Corp. v. Medtronic, Inc., 835 F.2d (Comment 17) Many comments agreed company,’’ the case may be dismissed 859 (Fed. Cir. 1987)). In Vanguard with our determination that the delay in because there was no ‘‘case or Research, Inc. v. PEAT, Inc., 304 F.3d approval of ANDA or 505(b)(2) controversy.’’ Another comment cited 1249, 1255 (Fed. Cir. 2002), the court applications could be limited to one 30- Teva Pharmaceuticals, USA, Inc. v. found that fear of a lawsuit existed month stay per application. Other FDA, 182 F.3d 1003 (D.C. Cir. 1999), to when the competitor was engaged in comments agreed with the limitation claim that if no notification were activity subject to a patent infringement but stated that the single 30-month received, arguably no declaratory action charge, and the patent holder already limitation was or should be: could be brought. Other comments had sued the competitor to protect its • Per drug; suggested that limiting NDA holders to technology. The court noted that: • Per ANDA, for all patents submitted a single 30-month stay per ANDA or ‘‘[f]iling a lawsuit for patent before any ANDA filing; or 505(b)(2) application would encourage infringement would be just another • Limited only to patents submitted the delay of litigation designed to logical step in its quest to protect its within 30 days of NDA approval. resolve patent issues and thus would technology.’’ This is similar to the

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situation in which an ANDA or of any other Hatch-Waxman patent that the plain meaning of ‘‘include’’ or 505(b)(2) applicant has filed an initial infringement case in which a court has ‘‘amended to include’’ is to ‘‘contain’’ or paragraph IV certification and the NDA found no reasonable apprehension of ‘‘comprise as part of a whole,’’ and that holder or patent owner has filed a suit. our interpretation of section lawsuit to protect the patent and obtain In response to the comments arguing 505(j)(2)(B)(iii) of the act is not a 30-month stay. There is little reason to that a single 30-month stay would create reasonable. The comments also argued doubt that an NDA holder or patent uncertainty regarding litigation and that our interpretation of ‘‘include’’ in owner who had submitted a second later-submitted patents, we note that a this provision differs from its use patent to us for listing would bring firm’s inability to predict whether it will elsewhere in section 505 of the act. One another lawsuit to protect the second or will not be sued for patent comment stated that the meaning of patent if an ANDA or 505(b)(2) infringement is a matter outside the ‘‘include’’ in sections 505(j)(7)(A)(ii) applicant were to manufacture the drug, scope of this final rule. A decision by and (iii) of the act cannot be reconciled even if no notice of a subsequent the NDA holder or patent owner on with our interpretation of that term in paragraph IV certification was provided. whether to file suit for patent section 505(j)(2)(B)(iii) of the act. In other words, the NDA holder or infringement may depend on many Section 505(j)(2)(B)(iii) of the act states patent owner should have an incentive factors. For example, litigation decisions that ‘‘If an application is amended to to protect the patented invention could be affected by the strength of the include a certification described in regardless of whether the ANDA or underlying patent, the party’s resources, subparagraph (A)(vii)(IV), the notice 505(b)(2) applicant provided notice. licensing agreements if the patented required by clause (ii) shall be given We acknowledge that the court in invention is made under a license, or when the amended application is Jervis B. Webb Co. v. Southern Systems, other factors. We also note that some submitted.’’ The comment noted that Inc., 742 F.2d 1388 (Fed. Cir. 1984), patent infringement suits may be section 505(j)(7)(A)(ii) of the act found that a case or controversy did not initiated after the 45 day period provides that the Secretary ‘‘shall revise exist when the plaintiff had not available to obtain a 30-month stay has the list [Orange Book] to include each produced a product (a device) at the expired. The act only requires the drug which has been approved . . . time of the declaratory judgment initiation of a patent infringement suit during the [intervening] thirty-day counterclaim. However, an ANDA or within a specific time if the NDA holder period’’ and, when that updated drug 505(b)(2) applicant is engaged in or patent owner wishes to get the benefit information is recorded ‘‘in revisions ‘‘producing’’ a product at the time the of a 30-month stay in the approval of an made under clause (ii), [shall] include ANDA or 505(b)(2) application is filed. ANDA or 505(b)(2) application; the such [patent] information for such Although 35 U.S.C. 271(e)(1) makes it NDA holder or patent owner can bring drug.’’ an act of non-infringement to use a suit at a later time, but loses the Several comments questioned patented invention for uses related to opportunity to obtain a 30-month stay of whether the legislative history of the submitting an ANDA or 505(b)(2) approval. Hatch-Waxman Amendments supported application (such as testing and In addition, there are various types of our proposed interpretation of section producing sample batches of drug patents which must not be submitted for 505(j)(2)(B)(iii) of the act. One comment product), 35 U.S.C. 271(e)(2) expressly listing in the Orange Book. These contended that House Report language makes it an act of infringement to patents are not subject to the (see 67 FR 65448 at 65456) we had cited submit an ANDA or 505(b)(2) certification, notice, and 30-month stay should be read as supporting multiple application seeking approval of the drug provisions. The fact that such patents 30-month stays. The comments also product before a patent expires. This must not be listed does not prevent the argued that our interpretation failed to statutory provision does not require that NDA holder or patent owner from consider the importance of the final the NDA holder or patent owner receive defending those patents in litigation as compromise that led to a 30-month, formal notice of a paragraph IV it deems appropriate. rather than 18-month, stay to ensure certification for the submission of the e. Is the Correct Legal Interpretation that patent litigation was resolved application to be an act of infringement. Applied to Provide Only One 30-Month before a generic drug was approved. Thus, unlike the plaintiff in Jervis B. Stay? Finally, other comments criticized our Webb Co. v. Southern Systems, Inc., the (Comment 19) Numerous comments failure to consider other language from second element of the case or challenged our proposed interpretation a House Report that allegedly shows controversy test would be satisfied. of the act to permit only one 30-month that Congress intended the availability In another case cited in the stay per ANDA or 505(b)(2) application. of multiple 30-month stays. This comments, Teva Pharmaceuticals, USA, Some comments advanced a legal language, found at H. Rept. 98–857, Part Inc. v. FDA, 182 F.3d 1003 (D.C. Cir. analysis different than the one we 1, 98th Cong., 2d Sess. at 28, states: ‘‘In 1999), the court explained that a case or described in the preamble to the the case where the patent certification is controversy did not exist in the proposal to support a single 30-month amended in an ANDA to allege underlying declaratory judgment action. stay. The comments asserted that their invalidity or non-infringement of a There was no reasonable apprehension legal theories were either better than patent, the FDA may not make the of suit—the first element of the case or ours or were the only appropriate legal approval effective within the 45 day controversy test—because the patent arguments possible. period that an action for patent owner had disavowed an intent to sue. In contrast, other comments infringement may be brought.’’ A disavowal of the intent to sue is an maintained that section 505(j)(2)(B)(iii) (Response) We agree that section unusual circumstance that we do not of the act requires that notice be 505(j)(2)(B)(iii) of the act can be read to expect to occur in many cases. In any provided to the NDA holder and patent permit multiple 30-month stays. Indeed, event, the availability of a declaratory owner each time a new paragraph IV this has been our position since the judgment action is less important when certification is added to an ANDA. enactment of the Hatch-Waxman the innovator or patent owner disavows These comments maintained that Amendments. The proposal put forth a an intent to sue because the ANDA multiple 30-month stays are clearly different interpretation, one that we applicant will face less risk in marketing required if the notices result in patent believe is equally reasonable and more its competing product. We are not aware litigation. Several comments contended in line with the intent of the Hatch-

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Waxman Amendments—to maintain a Our interpretation ensures that the language may plausibly be read in balance between the rights of the NDA NDA holder and patent owner will different ways. It is certainly reasonable holders and patent owners, and the receive notice of at least one paragraph to interpret ‘‘include’’ as used in the act desire to have more rapid availability of IV certification and have one full to mean ‘‘contain.’’ That is the meaning generic drugs. Our revised opportunity for a 30-month stay. we understood the word to have when interpretation of section 505(j)(2)(B)(iii) However, we also disagree that every we issued the proposed rule (see 67 FR of the act accomplishes two statutory paragraph IV certification requires 65448 at 65455). Thus, it is a reasonable objectives: (1) It closes a possible notice and an opportunity for a 30- construction of the act to conclude that loophole that would have allowed month stay. We will require notice to when an application is amended to ANDA applicants to avoid any 30- the NDA holder and patent owner of a contain a paragraph IV certification month stay and (2) it prevents multiple later paragraph IV certification if: (1) (when it did not previously contain 30-month stays per ANDA application. The ANDA or 505(b)(2) application did such a certification), it is thus amended A similar conclusion applies to the not previously contain a paragraph IV to include such a certification; and, that parallel provisions of section 505(b)(2) certification, but is amended to include once an application contains such a of the act. a paragraph IV certification; or (2) a certification, adding a new one does not We based our change in position on previous notice of a paragraph IV amend or change the application to a reevaluation of the statutory text and certification did not result in one full include or contain one, since it already concluded that the act is ambiguous on opportunity for the 30-month stay under contained such a certification. In any this issue of multiple 30-month stays. the act. event, reliance on words in isolation is We note that certain other legal This approach is consistent with the misplaced. As Judge Learned Hand interpretations or theories may support statutory language. By its terms, section observed, ‘‘Words are not pebbles in a single 30-month stay, but we believe 505(j)(2)(B)(i) of the act, and the nearly alien juxtaposition; they have only a that the position we have taken in the identical language applicable to communal existence; and not only does final rule is the most appropriate. 505(b)(2) applicants, requires that the the meaning of each interpenetrate the The preamble to the proposed rule ANDA applicant submitting a paragraph other, but all in their aggregate take their explained the rationale for our different IV certification in its original ANDA purport from the setting in which they interpretation (see 67 FR 65448 at 65454 ‘‘include in the application’’ that it will are used***.’’ NLRB v. Federbush to 65456). In brief, after reviewing the provide the required notice. Section Co., 121 F.2d 954, 957 (2d Cir. 1941). text of section 505(j)(2)(B)(i) through 505(j)(2)(B)(ii) of the act sets forth the Our interpretation of the 30-month stay (iii) of the act, we believe that these required content of the notice referred to provision is fully consistent with this provisions may be reasonably in clause (i). Under section principle. interpreted so that notice and the 505(j)(5)(B)(iii) of the act, we are opportunity for a 30-month stay do not prohibited from approving an We also reject the view that our flow from all paragraph IV application with a paragraph IV interpretation of the statutory language certifications. However, one notice of a certification if an action has been ‘‘amended to include’’ is inconsistent paragraph IV certification and one full brought within 45 days of the date the with the use of the word ‘‘include’’ opportunity for a 30-month stay will notice under section 505(j)(2)(B)(i) is elsewhere in the statute. We do not always be required. This outcome—the received. The text of section agree that the use of ‘‘include’’ in opportunity for one 30-month stay 505(j)(5)(B)(iii) refers multiple times to section 505(j)(7)(A)(ii) and (j)(7)(A)(iii) during which patent rights can be ‘‘the notice provided [or made] under of the act cannot be squared with our litigated, but no multiple 30-month paragraph (2)(B)(i).’’ Thus, at a interpretation of that term in section stays per ANDA or 505(b)(2) application minimum, it cannot be said the statute 505(j)(2)(B)(iii) of the act. Sections to unreasonably delay approvals of clearly applies the notice requirement to 505(j)(7)(A)(ii) and (j)(7)(A)(iii) of the competitor drugs—is a reasonable and all paragraph IV certifications, whether act, which relate to updating the Orange balanced interpretation of the act. in original or amended ANDAs. Book every 30 days to take into account We disagree with the comments that By contrast, section 505(j)(2)(B)(iii) of drug approvals and patent listings, claimed that notice and 30-month stays the act refers to amended, not original, provide that the Secretary ‘‘shall revise are required only for paragraph IV ANDAs. It addresses the question of the list to include each drug which has certifications contained in original notice when an ANDA is amended to been approved * * * during the ANDAs because the notice provision at include a paragraph IV certification. Our [intervening] thirty-day period’’ and section 505(j)(2)(B)(ii) references only interpretation eliminates the possibility when that updated drug information is section 505(j)(2)(B)(i) of the act. This that an ANDA applicant could evade recorded, ‘‘in revisions made under interpretation would eliminate the any notice that could lead to a 30-month clause (ii), [shall] include such [patent] opportunity for a 30-month stay in any stay by omitting any paragraph IV information for such drug.’’ That situation where an ANDA applicant certification in an original ANDA, and language requires publication of waits until an amendment to submit a then later amending the application to revisions to include something that was paragraph IV certification. As we include such a certification. By not previously contained in the Orange explained in the proposed rule (see 67 providing one full opportunity for the Book, i.e., approved drugs and patents FR 65448 at 65455 to 65456), section 30-month stay, we reduce the that were not listed in the version of the 505(j)(2)(B)(iii) of the act specifically opportunity for intentional Orange Book that existed immediately requires ANDA applicants to give notice manipulation of the filing of paragraph before the amendments were filed. The if they amend their applications to IV certifications. Secretary would publish nothing, under include their first paragraph IV We do not agree that the act’s this statutory directive, if in the certification. For these reasons, we do language governing the operation of preceding 30 days, no new drugs were not interpret the act to require that only paragraph IV certifications, notice, and approved or patent listings filed. paragraph IV certifications contained in 30-month stays is clear and Similarly, when an ANDA or 505(b)(2) original ANDA applications will trigger unambiguous. As the multiple application is amended to include a the notice requirements and the interpretations advanced by the paragraph IV certification, when no possibility of a 30-month stay. comments demonstrate, the statutory such certification is contained in the

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application prior to the amendment of the first time, we cannot approve the significant delays in the approval of the application, section 505(j)(2)(B)(iii) application for 45 days, and notification generic versions of frequently of the act applies. But when an ANDA of the paragraph IV certification will be prescribed drugs. We anticipate that if or 505(b)(2) application contained a required. For additional paragraph IV we do not address the current situation, paragraph IV certification prior to the certifications, when a patent has already these multiple 30-month stays and amendment and one full opportunity resulted in a paragraph IV certification resulting delays in generic drug arose for a 30-month stay, no notice and a full opportunity for a 30-month approvals would continue to increase. obligation is triggered for subsequent stay, no notice is required and we do There will be an increasing number of paragraph IV certifications. not need to wait for 45 days to approve patents expiring in the next few years We do not agree with the comment an ANDA or 505(b)(2) application if it covering innovator drugs currently on that the legislative history indicates that is otherwise ready for approval. the market. According to our records, Congress changed the 18-month stay to f. Is There a Sufficient Basis to Adopt over 500 drug patents will expire a 30-month stay because it intended that the Change in Legal Interpretation? In between 2003 and 2009. We have patent litigation be resolved before a the preamble to the proposed rule, we identified 26 top-selling drugs subject to generic application could be approved. detailed the factual basis for our patents with expiration dates between The House Judiciary Committee rejected decision to reevaluate our legal 2003 and 2005. These 26 drugs had an ‘‘amendment [that] would have interpretation of the maximum number combined 2001 retail sales exceeding required that either the patent expire of 30-month stays per ANDA or $38 billion (over 25 percent of all 2001 before approval, or that there be a final 505(b)(2) application (see 67 FR 65448 prescription drug expenditures) and decision by a Federal District Court that at 65455). We noted that our impression include 7 of the top 10 best selling the patent in question was not valid’’ that multiple 30-month stays were drugs. The pressure on NDA holders (see H. Rept. 98–857, Part 2, 98th Cong. increasing was confirmed by the FTC and innovator companies to protect 2d Sess., 9 (1984)). It appears that the Report. In addition, the FTC Report their market share and delay generic amendment was rejected because the found that there was an increase in competition into the market will effect ‘‘would have been to substantially submission of later-issued patents, continue to increase. We would expect delay generics from getting onto the many of which ‘‘do not appear to claim to see an increase in the conduct market when they seek to challenge the the approved drug product or an documented in FTC Report if our validity of a patent’’ (id. at 10). Congress approved use of the drug’’ (id.). regulations remained the same. explicitly rejected amendments to (Comment 20) Several comments The FTC’s comprehensive and prohibit generic entry before judicial questioned the factual basis for what discerning analyses of the data it resolution of the patent issues prior to they called our ‘‘dramatic change in collected substantiated the seriousness approval, but accepted a 30-month stay position’’ and argued that the of the problem. The FTC analyzed the period, whether or not litigation was information used in the FTC Report was relationship between patent listings and finally resolved, because, as a practical already known to us. Since there was no multiple 30-month stays, conducted an matter, it was believed the time period ‘‘new information,’’ the comments extensive review of various lawsuits would not affect when generic maintained that the facts did not involving multiple 30-month stays provide an ‘‘adequate’’ basis for our manufacturers would begin to market (including lawsuits in which we were adoption of a single 30-month stay per their drugs (see 130 Congressional not a party) and analyzed the outcome Record H9118 (September 6, 1984) ANDA or 505(b)(2) application. (Response) We disagree with the of the litigation. Although we provided (remarks of Rep. Waxman)). some raw data to the FTC to assist its We also believe that the legislative contention that our factual basis investigations (and thus that history quoted in the comments is underlying our rule was inadequate. At information was not ‘‘new’’ to us), we ambiguous at most and can be the outset, we note that the comments did not have all of the data that the FTC interpreted in a way that does not proceed from a false premise to a flawed collected nor had we analyzed the data undercut our changed interpretation. conclusion. The ‘‘newness’’ of the in the manner done by the FTC. The report states: ‘‘In the case where the underlying data is not the appropriate We have concluded that our patent certification is amended in an legal standard for evaluating the regulations permitting multiple 30- ANDA to allege invalidity or non- reasonableness of our different month stays have led to considerable infringement of a patent, the FDA may interpretation. An agency must consider delays in the approval of generic drugs. not make the approval effective within ‘‘the wisdom of its policy on a the 45 day period that an action for continuing basis’’ ‘‘with or without a This consequence was not intended patent infringement may be brought.’’ change in circumstances’’ (see Chevron, either by Congress or by FDA. Thus, we Although this language does not U.S.A., Inc. v. Natural Resources have changed our regulations to address distinguish explicitly between Defense Council, Inc., 467 U.S. 837, 863, this problem. situations when an application already 104 S. Ct. 2778, 2792 (1984); Motor B. Miscellaneous Comments contained a paragraph IV certification Vehicle Manufacturers Ass’n v. State and those when it did not, it would not Farm Mut. Automobile Ins. Co., 463 U.S. 1. Do We Need Legislation to be unreasonable to interpret it to apply 29, 57, 103 S. Ct. 2856, 2873 (1983)). Accomplish Our Goals? only when invalidity or non- Our pre-existing regulations permitting The preamble to the proposed rule infringement of a patent is alleged for multiple 30-month stays have led to did not discuss any legislative efforts to the first time. Language describing when protracted delays in generic drug enhance the availability of generic an ANDA is ‘‘amended***to allege approvals and, therefore, need to be drugs. invalidity or non-infringement of a changed. (Comment 21) Several comments said patent’’ can be read in another way as If ‘‘newness’’ of the underlying data that legislation would be better than ‘‘amended to include’’ a paragraph IV were the test, the data here would rulemaking or that we should support certification. When an ANDA or satisfy it. Over the last several years, legislation. In general, the comments felt 505(b)(2) application is amended to there has been an increasing number of that legislation would: include an allegation of invalidity or multiple 30-month stays for a single • Better resolve intellectual property non-infringement of a listed patent for drug product. These stays have caused issues than our rule;

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• Give us clear legal authority to act interpretation of a prior statute. this final rule could affect the number or be less vulnerable to judicial review; Congressional inaction lacks persuasive of exclusivity periods. Other suggestions or, significance because several equally tenable made in the comments are beyond the • Result in timely and predictable inferences may be drawn from such inaction, scope of the final rule. We are not access to generic drugs. including the inference that existing altering our interpretation of exclusivity One comment noted that Congress legislation already incorporated the offered change. in the final rule. had considered several bills to address (See Central Bank of Denver v. First 30-month stays. The comment declared 3. Should the Provisions of the Final Interstate Bank of Denver, 511 U.S. 164, that such proposed legislative action Rule Be Severable? 187 (1994).) indicated both that we lacked authority The proposed rule did not address (Citations and internal quotation marks to issue the rule and that new legislation whether each provision should be omitted.) was needed. Another comment considered independent of other suggested that we support legislation to Although it would be both provisions and, thus, severable if any allow only one 30-month stay and only inappropriate and premature for us to provision were determined to be for patents that are listed within 30 days take a position on any legislative invalid. of an NDA’s initial approval. concept without seeing the details of (Comment 23) Although there were no (Response) We believe that, under our any specific proposed or draft comments that directly addressed existing regulations, there have been legislation, we are always willing to severability, one comment suggested delays in generic drugs reaching the work with Congress. Until then, we will that the limitation on multiple 30- market, as well as confusion over not take a position on legislation to months stays was unnecessary because certain patent listing requirements. This allow only one 30-month stay for the revised patent listing provisions rule is intended to help ensure that patents filed within 30 days after NDA would prevent improper patents from lower cost, safe and effective generic approval. being submitted for listing in the Orange drugs become available to Americans 2. Will the Different Interpretation Book. without any inappropriate delays, while Affect Existing Exclusivities? (Response) Although we agree that the still preserving incentives to innovate. changes to the patent submission and These changes can be achieved through We stated in the preamble to the listing provisions and the information rulemaking, using our existing legal proposed rule that the implementation required on the declaration forms will authority. We cannot predict whether, if of the final rule would not affect an help ensure that improper patents are at all, legislation addressing these issues ANDA’s eligibility for 180-day not submitted for listing, we also believe will be enacted. The possibility that exclusivity under 505(j)(5)(B)(iv) of the that eliminating multiple 30-month there could be legislation to address act (see 67 FR 65448 at 65457). stays will help maintain the balance problems associated with 30-month (Comment 22) Several comments intended by the Hatch-Waxman stays and generic drug approvals addressed different aspects of the 180- Amendments and is equally important cannot, and should not, preclude us day and 3 year exclusivity provisions of to the final rule. Each of the final rule from using our existing authority to the Hatch-Waxman Amendments. The provisions reinforces interrelated goals. address these problems. We also note comments offered suggestions on Clarifying that certain patents may not that those comments favoring legislative changing the exclusivity trigger, be submitted for listing should lead to solutions over regulatory ones requiring the forfeit of the exclusivity if the submission of fewer improper apparently assume that legislative parties agree to delay marketing and patents. Requiring additional patent changes would necessarily lead to less expressed concerns about the potential declaration information from NDA litigation than a rule. Based on our past increase in the availability of 180-day applicants or holders or patent owners experience in defending statutory exclusivity if we allow additional also should help ensure that only interpretations, we question whether patents to be filed. eligible patents are submitted. such a presumption is appropriate here. (Response) We appreciate the Eliminating the opportunity for multiple We recognize that a regulation may not complexities of the various exclusivities 30-month stays also should reduce always be a perfect solution due to provided by the act. As we noted in the incentives to submit improper patents. limits on our statutory authority, but proposed rule, eligibility for 180-day Based on our past experience we that recognition does not mean that we exclusivity will follow the same general acknowledge that the provisions of this cannot use our existing legal authority principles as before implementation of final rule will neither completely to engage in rulemaking to improve our this final rule. The first ANDA applicant resolve all issues governing patent regulatory approach. to file a substantially complete ANDA, submission, nor will they eliminate Additionally, we disagree with the or supplement, containing a paragraph attempts to manipulate the final rule for comments that claimed we lack IV certification to a listed patent will be market advantage. We also believe that authority to issue the rule. The eligible for exclusivity as to that patent each provision will reduce the preamble to the proposed rule discussed under section 505(j)(5)(B)(iv) of the act. opportunities for manipulation and, our legal authority (see 67 FR 65448 at For a paragraph IV certification to be thus, is independently justified and 65457). We will not repeat that effective for exclusivity purposes, when worthwhile. However, we believe each discussion here. The fact that Congress notice is required, notice must be given provision stands on its own as a legal has considered, or is currently as described in the response to comment and practical matter. considering, bills on the 30-month stay 13 of section II.A of this document. From the comments we have received issue does not preclude us from However, when notice is not required, to the proposed rule, we believe there is exercising our existing authority, nor a paragraph IV certification will be a possibility that we will be challenged demonstrate that we presently lack that effective for exclusivity purposes on various portions of the final rule. We authority. As the Supreme Court has without notice. We understand that expect we will prevail in any such explained: each patent listed in the Orange Book challenge, as the final rule and each of We have stated***that failed may form the basis for a claim to 180- its provisions is legally sound. If, legislative proposals are a particularly day exclusivity. Thus an increase or however, a court should conclude that dangerous ground on which to rest an decrease in listed patents as a result of any one or more provisions of the final

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rule is invalid, we wish to emphasize declaration requirements, and ANDA or patent owners who have not already our intent that the remaining provisions 505(b)(2) application applicants would conducted testing. The 6 months will of the final rule be permitted to take not have to provide notice if their provide time for NDA applicants and effect. applications previously contained a holders and patent owners with patents paragraph IV certification. Only one 30- 4. Implementation and Effective Date pending at the PTO to conduct the tests month stay per each ANDA’s or needed to produce the data required for The preamble to the proposed rule 505(b)(2) application’s approval date the declaration statement in time to described how a final rule would be would be possible. submit any newly issued patent within applied to pending applications (see 67 We invited comment on how a final rule 30 days of issuance. FR 65448 at 65457) as follows: should be implemented. • For patents filed for an NDA that has (Comment 24) Several comments We also decline to apply the final rule not been approved by the effective date suggested alternative effective dates retroactively. If we canceled all multiple of a final rule, the rule would apply on including the following: 30-month stays currently applicable to the effective date. For example, if the • Apply the final rule to all ANDAs ANDAs and 505(b)(2) applications or final rule were to become effective 60 filed before the effective date of the final applied the declaration requirements to days after the date of publication in the rule and cancel any existing multiple already submitted patents for existing Federal Register, and an NDA was 30-month stays; • NDAs, we would be applying the pending on the 60th day after the final Apply the final rule retroactively to provisions retroactively. As we noted in rule’s publication date, the NDA all current NDA holders by requiring all the proposal (67 FR 65448 at 65457): ‘‘If NDA holders to be subject to only one applicant would have to comply with we were to adopt an alternative the final rule’s patent listing and patent 30-month stay and apply the declaration implementation plan, we would risk declaration requirements. ANDA and provisions to require all current NDA upsetting legitimate expectations held 505(b)(2) application applicants would holders or patent owners to file a new be subject to the revised notice declaration and certification for already by those who had relied on our earlier requirement. Each ANDA or 505(b)(2) listed patents using the declaration interpretation of the act.’’ As a general application referencing that NDA would statement in the proposal; matter, a statutory grant of legislative be subject to the possibility of only one • Apply the new declaration rulemaking does not encompass the 30-month stay per ANDA or 505(b)(2) requirements retroactively to require the power to implement such regulations on application. new information on patents currently a retroactive basis in the absence of • If we have approved the NDA as of listed in the Orange Book; if the express language granting such power the final rule’s effective date, and no propriety of a patent listed in Orange (see Bowen v. Georgetown University ANDA has been filed before that date, Book for a current NDA holder or patent Hospital, 488 U.S. 204, 208–09 (1988)). then any patent listed before that date owner is questioned, the NDA holder or There is no question that this rule would be subject to the pre-existing patent owner must file a new ‘‘changes the legal landscape’’ (see regulation. For example, if the final rule declaration or FDA should delist the National Mining Ass’n v. Department of were to become effective 60 days after patent. Labor, 292 F.3d 849, 858 (D.C. Cir. the date of publication in the Federal In contrast, other comments supported 2002)). Applying this rule retroactively Register, and we approved the NDA on the implementation plan as proposed. would subject us to potential legal the 59th day after the date of (Response) We will implement the challenge. Thus, adopting these final rule on a prospective basis, as we publication, the NDA applicant would suggestions would lead to even greater stated in the proposed rule. The fact that not have to amend its patent listing and uncertainty as to the applicability of the patent declaration to comply with the we made our intent public in a provisions. final rule. ANDA and 505(b)(2) proposed rule and the time lag between applications submitted after the when the rule was proposed and when After further consideration, however, effective date would be subject to the this final rule is effective provides we believe that the proposed rule’s revised notice requirement. Each ANDA sufficient time for most parties to adjust implementation plan will not fully or 505(b)(2) application referencing that their practices and expectations, or to effect our intent to implement the NDA would be subject to the possibility take other steps to suit their business provisions only prospectively. of only one 30-month stay per ANDA or practices. Accordingly, as described in section IV 505(b)(2) application. We do delay the implementation date of this document, we have clarified our • If we have approved the NDA as of for submission of information implementation plan to ensure the final rule’s effective date, and an concerning a patent claiming a prospective application of the final rule. ANDA or 505(b)(2) application has been polymorph that is the active ingredient Nevertheless, patent owners may filed before that date, then any patent of the drug product described in the voluntarily complete, and NDA holders listed before that date would be subject approved NDA. We provide a longer may voluntarily complete and submit, to the pre-existing regulations, as period of implementation to new patent declarations, using FDA accommodate the tests required to described in the example immediately Forms 3542 and 3542a, for patents not establish that the drug product above. The ANDA or 505(b)(2) subject to the final rule and currently application applicant would have to containing the polymorph will perform listed in the Orange Book. This course provide notice to the patent owner and the same as the drug product described is particularly advisable for method-of- NDA holder if the ANDA or 505(b)(2) in the NDA. This test data must exist application contained a paragraph IV when a polymorph patent is submitted use patents, in light of the Purepac certification. Multiple 30-month stays in to us. We recognize that the testing decision and concerns about the approval date would be possible. necessary to obtain the data for implementation of section • If the NDA holder or NDA applicant submission of polymorph patents 505(j)(2)(A)(viii) of the act. Such files patent information after the final claiming the active ingredient of the voluntary submission of new patent rule’s effective date, then the NDA product described in the NDA may take declarations will not bring patents holder or applicant is subject to the final at least 6 months to complete. There within the scope of the final rule with rule’s patent listing and patent will be NDA applicants and holders and respect to notice and 30-month stays.

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III. Description of the Final Rule Section 314.53(c)(2)(i) requires a person such paragraph IV certification and submitting an NDA, an amendment, or related notice are not considered to have A. Section 314.53(b)—What Patents a supplement, to submit an original satisfied the requirement of providing Must Be Submitted? signed declaration form as part of its one notice of a paragraph IV 1. Which Patents Would the Final Rule submission of patent information. The certification and a full opportunity for a Require To Be Submitted? appropriate declaration form must be 30-month stay. used for submitting patent information. Section 314.53(b) describes the The information required to be IV. Implementation patents for which information must be submitted is described. Each form seeks The final rule will be effective on submitted. The final rule states, in specific patent information and requires August 18, 2003. relevant part, that information must be a signed attestation from the NDA • Patent information submitted to us submitted on the required declaration applicant or holder or patent owner that (FDA) before the effective date will be forms for each patent that claims the the information is accurate and subject to our pre-existing regulations drug or a method of using the drug that complies with the requirements of the governing patent submission, is the subject of the NDA and with regulations. declarations, certifications, notice and respect to which a claim of patent Section 314.53(c)(2)(ii) requires that availability of 30-month stays; infringement could reasonably be the NDA holder submit a declaration • Patent information submitted to us asserted if a person not licensed by the form with information relating to the on or after the effective date will be owner of the patent engaged in the approved NDA and additional subject to the final rule’s provisions manufacture, use, or sale of the drug information on use codes within 30 governing patent submission, product. The patents include patents days of NDA approval. The information accompanying declarations, that claim: required to be submitted is described. certifications, notice and availability of • The drug substance (active Each form includes specific patent 30-month stays; ingredient), information and requires a signed • Patent information submitted to us • The drug product (formulation and attestation from the NDA holder or on a newly applicable claim, even if the composition), and patent owner that the information is patent was previously submitted to us, • A method of use. accurate and complies with the will be subject to the final rule’s Those patents that claim a different requirements of the regulations. This provisions. polymorphic form of the drug substance section also requires submission of The final rule will have a compliance that is the active ingredient described in information on patents submitted for date of December 18, 2003, for patent the NDA must be submitted if the listing after NDA approval. This information submitted to us on patents applicant has test data demonstrating declaration form is the only declaration claiming a polymorph of the same active that a drug product containing the form that we will rely on to determine ingredient of the product described in polymorph will perform the same as the whether a patent is eligible for listing the NDA. drug product described in the NDA. The based on the patent information As a result, within a single same drug product (formulation and submitted. approved or pending NDA, some composition) patents submitted must patents may be subject to our pre- claim the specific drug product C. Section 314.53(c)(3)—What Is existing regulations while other patents described in the pending or approved Required to Be Filed If There Are No may be subject to the final rule. The NDA. For patents that claim a method Relevant Patents? date on which the patent information of use, the NDA applicant or holder The final rule modifies the statement was submitted to us will determine must submit only those patents that used to describe the fact that the NDA which set of regulations applies. claim indications or other conditions of applicant or holder believes there are no We believe that the effective dates use that are the subject of a pending or relevant patents to be submitted. The will provide adequate time for the NDA approved application. Each pending or language is changed to conform to the applicants, NDA holders, and patent approved method of use and related descriptions used for drug substance owners to adjust their business patent claim must be described. (active ingredient), drug product practices. The patent information (formulation and composition) and required for submission is information 2. What Patents Must Not Be Submitted? method of use to those used in the other readily available to the NDA applicants Section 314.53(b), as finalized, states regulatory provisions. and holders and patent owners. that information on patents claiming We have delayed the implementation D. Sections 314.95(a) and 314.52(a)— packaging, patents claiming metabolites, date for patent information to be When Are Notice and Certification and patents claiming intermediates submitted to us on patents claiming a Required? must not be submitted. Process patents polymorph that is the active ingredient also must not be submitted. The final The final rule modifies §§ 314.95(a) of the drug product described in the rule clarifies that the prohibition on and 314.52(a) to state that, if an ANDA approved NDA. NDA applicants and submission of packaging patents does or 505(b)(2) application is amended to holders and patent owners with patents not apply to patents that claim the drug include a paragraph IV certification, pending at the PTO will have additional product as defined in § 314.3. If a patent notice must be provided to the NDA time (i.e., until 6 months after the date claims the finished dosage form of the holder and patent owner only if the of publication in the Federal Register) drug product, it must be submitted for application did not already contain a to conduct the tests needed to produce listing. paragraph IV certification or there was the data required for the declaration not a full opportunity for a 30-month statement in time to submit any newly B. Section 314.53(c)—What Does the stay. If an ANDA or 505(b)(2) applicant Patent Declaration Say? issued patent within 30 days of changes its paragraph IV certification issuance. Section 314.53(c)(1) describes the before the 45-day period after notice to general requirements for submission of the NDA holder and patent owner has V. Legal Authority patent information and the conditions expired, and the NDA holder or patent Our principal legal authority for the for acceptance of the patent information. owner has not initiated patent litigation, final rule is section 505 of the act, in

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conjunction with our general the human environment. Therefore, Title: Applications for FDA Approval rulemaking authority in section 701(a) neither an environmental assessment to Market a New Drug: Patent (21 U.S.C. 371) of the act. Section 505(b) nor an environmental impact statement Submission and Listing Requirements and (c) of the act describes the contents is required. and Application of 30-month Stays on of an NDA and 505(b)(2) application, Approval of Abbreviated New Drug including the patent submission and VII. Executive Order 13132: Federalism Applications Certifying That a Patent patent certification requirements. We have analyzed this final rule in Claiming a Drug Is Invalid or Will Not Section 505(j) of the act describes the accordance with the principles set forth Be Infringed contents of an ANDA, including patent in Executive Order 13132. We have Description: The final rule clarifies certification requirements. Sections determined that this final rule does not the types of patent information that 505(b)(2)(A) and 505(j)(2)(A)(vii) of the contain policies that have substantial must and must not be submitted to FDA as part of an NDA, an amendment or act, respectively, require patent direct effects on the States, on the certifications, while sections 505(b)(3) supplement. The final rule also requires relationship between the National and 505(j)(2)(B) of the act require those persons submitting an NDA, Government and the States, or on the applicants who have made a paragraph amendment or supplement, or distribution of power and IV certification to provide notice to the submitting information on a patent after responsibilities among the various NDA holder and patent owner. NDA approval, to make a detailed levels of government. Accordingly, we The final rule clarifies the types of patent declaration using required FDA have concluded that the final rule does patents which NDA applicants and NDA declaration forms. The final rule permits not contain policies that have holders must and must not submit to the possibility of only one 30-month federalism implications as defined in FDA for listing in the Orange Book. It stay per each ANDA or 505(b)(2) the order and, consequently, a also requires a more detailed patent application’s approval date in the event federalism summary impact statement is declaration from NDA applicants and of patent infringement litigation because not required. NDA holders or patent owners using the final rule does not require ANDA or declaration forms. The specific legal VIII. Paperwork Reduction Act of 1995 505(b)(2) applicants to provide a notice authority for each provision is set forth of certification of invalidity or in the preamble discussion This final rule contains information noninfringement of a patent if the accompanying it. collection requirements that are subject application already contains such a For ANDA and 505(b)(2) applicants, to public comment and review by the certification or if a full opportunity for the final rule reduces the number of Office of Management and Budget a 30-month stay resulted after such notifications sent to patent owners and (OMB) under the Paperwork Reduction notice. NDA holders. The specific legal Act of 1995 (44 U.S.C. 3501–3520). We Description of Respondents: Persons authority for this action is set forth in describe these provisions below in this submitting an NDA, amendment or the preamble discussion of our changed section of the document with an supplement, or submitting information interpretation. estimate of the annual reporting burden. on a patent after NDA approval, and Our estimate includes the time for persons submitting an ANDA or VI. Environmental Impact reviewing instructions, searching 505(b)(2) application containing a We have determined under 21 CFR existing data sources, gathering and patent certification of invalidity or 25.30(h) and 25.31(a) that this action is maintaining the data needed, and noninfringement of a patent. of a type that does not individually or completing and reviewing each We estimate the burden of this cumulatively have a significant effect on collection of information. collection of information as follows:

TABLE 1.—ESTIMATED ANNUAL REPORTING BURDEN1

Frequency of Total Annual Hours per 21 CFR Section No. of Respondents Responses Responses Response Total Hours

314.50(a) through (f), (h), and (k) (citing 21 CFR 314.53) FDA Forms 3542 and 3542a 107 2.8 296 1,684 498,464 314.50(i)(1)(i) and 314.94(a)(12) 74 1.5 111 4 444 314.52(a)(3) and 314.95(a)(3) 74 1.01 74 12 897

Total 499,805 1 There are no capital costs or operating and maintenance costs associated with this collection of information.

Our estimates are based on the or 505(b)(2) application or when the will not require notice. In previous following assumptions. For the years application is amended to include a estimates, we have combined the 1998 to 2002, the annual number of paragraph IV certification or when such information collection burden for both original applications we have received notice did not provide a full the notice and certification. For containing a paragraph IV certification opportunity for a 30-month stay, this purposes of the final rule, we assume has been 61, 58, 79, 90, and 82, would mean that these applicants that the certification information respectively. The annual average is 74 would provide one notice to NDA collection burden is 4 hours and the ((61 certifications + 58 certifications +79 holders and patent owners, and, in rare information collection burden for the certifications + 90 certifications + 82 instances, a second notice. We increase notice is 12 hours. We also account for certifications) / 5 years = 74 the frequency of response to account for the multiple number of certifications certifications / year). Because the final these rare second notices. There may that may have to be provided by an rule requires notice of a paragraph IV still be multiple certifications made by ANDA or 505(b)(2) applicant. Under certification filed in the original ANDA ANDA or 505(b)(2) applicants which pre-existing regulations, we have had

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NDA holders submit two or more those patents. On the other hand, displays a currently valid OMB control patents for a single NDA. While this § 314.53(b) will require NDA applicants number. may continue to occur, we believe that and holders or patent owners to submit IX. Analysis of Economic Effects this final rule may reduce the number patent information on different forms of of patents submitted for listing because the active ingredient described in the We have examined the impacts of the we have clarified the type of patents NDA, and this could result in more rule under Executive Order 12866, and that must be submitted. The number of patent information being submitted or the Regulatory Flexibility Act (5 U.S.C. patents submitted could increase less patent information if test data do 601–612), and under the Unfunded because we allow polymorph patents to not exist to demonstrate that a drug Mandates Reform Act (UMRA) (2 U.S.C. be submitted or it could decrease if no product containing the polymorph will 1501 et seq.). Executive Order 12866 test data exist to demonstrate that a drug perform the same as the drug product directs agencies to assess all costs and product containing the polymorph will described in the NDA. We cannot benefits of available regulatory perform the same as the drug product determine whether the potential net alternatives and, when regulation is described in the NDA. We, thus, effect will increase, decrease, or not necessary, to select regulatory estimate the number of annual change the overall burden associated approaches that maximize net benefits certifications at 1.5 x 74 (the number of with submitting patent information, so (including potential economic, original certifications). Thus, the we have not assigned any change in the environmental, public health and safety, information collection burden for total reporting burden for the change in and other advantages, distributive §§ 314.50(i)(1)(i) and 314.94(a)(12) patent information alone. impacts, and equity). Unless the agency certifies that the rule is not expected to (certifications) would be 444 hours (74 In contrast, § 314.53(c) makes the have a significant economic impact on respondents x 1.5 response per patent declaration more detailed. The a substantial number of small entities, respondent x 4 hours per response = 444 change in the declaration will increase the Regulatory Flexibility Act, as hours). The information burden for the burden hours per response under amended by the Small Business §§ 314.52(a)(3) and 314.95(a)(3) (notices) § 314.50(h) (the provision under which Regulatory Flexibility Act (SBREFA), would be 897 hours (74 respondents x we covered patent declarations requires agencies to analyze regulatory 1.01 response per respondent x 12 hours described in § 314.53(c)) because options that would minimize any per response). respondents will be required to be more To estimate the number of enhanced significant economic impact of a rule on precise in their declarations. Based on small entities. Section 202 of UMRA patent declarations that will be other rules that require respondents to submitted annually, we referred to requires that agencies prepare a written compile and submit information in their historical data on patent submissions. statement of anticipated costs and possession, we estimate that the For the years 1998 to 2002, the numbers benefits before proposing any rule that information required to be submitted on of patents submitted to us were 159, may result in expenditures by State, the patent declaration forms, FDA 205, 321, 280, and 268 respectively, for local, and tribal governments in the Forms 3542 or 3542a, will result in an an annual average of 246.6 ((159 patents aggregate, or by the private sector, of additional information collection +205 patents +321 patents+280 $100 million in any one year (adjusted burden of 18 hours. However, the patents+268 patents) / 5 years = 247 annually for inflation). We have previous burden hour estimate of 1,666 patents / year). Because many of these conducted analyses of the rule, and hours for § 314.50 covered paragraphs individual patents are included in have determined that the rule is multiple NDA submissions, there could (a) through (f), in addition to paragraphs consistent with the principles set forth be multiple declarations for a single (h) and (k) (see 66 FR 29143 at 29146, in the Executive Order and in these patent. From our review of submissions, May 29, 2001). We are unable to statutes. we believe the number of duplicate determine how many of the 1,666 hours The final rule is a significant patent listings to be 20 percent of the were devoted to patent declarations, so, regulatory action as defined by the number of unique patents. Therefore, in this table, we simply add 18 hours to Executive Order. With respect to the we estimate 49.2 (246.6 patents x 20 the 1,666 hour estimate for § 314.50(a) Regulatory Flexibility Act, we certify percent) patent declarations will be through (f), (h), and (k), resulting in a that this final rule is not expected to multiple listings, and there will be 296 burden hour estimate of 1,684 hours have a significant impact on a (247 declarations + 49 declarations = (1,666 hours + 18 hours) to account for substantial number of small entities. 296 declarations) total annual patent a respondent’s need for more time to This regulatory action is also a major declarations. As we received 115 and 99 make and verify the patent declaration. rule under the Congressional Review NDAs in 2000 and 2001, respectively, Thus, the information collection burden Act. The discussion of costs and we assume there will be 107 ((115 for § 314.50(a) through (f), (h), and benefits is consistent with the applications + 99 applications) / 2 years (k)(citing § 314.53) will increase from requirements of the UMRA. = 80 applications / year) instances the estimate we made in the proposed A. Summary where an NDA holder would be affected rule of 209,560 hours to 498,464 hours by the patent declaration requirements (296 annual responses x 1,684 hours per The economic impacts arise from a and that each of these holders would, on response = 498,464 hours). variety of effects of this rule. The average, submit 2.8 (296 declarations / The information collection provisions primary effect is the elimination of 107 instances = 2.8 declarations per of this final rule have been submitted to multiple 30-month stays, which (as instance) on FDA Forms 3542 or 3542a. OMB for review. Prior to the effective explained earlier) will result in earlier However, § 314.53(b) and (c) have date of this final rule, FDA will publish market entry by generic drug different impacts on the hours per a notice in the Federal Register manufacturers without appreciable response. On the one hand, § 314.53(b) announcing OMB’s decision to approve, effects on pharmaceutical innovation. might decrease the reporting burden modify, or disapprove the information Earlier generic competition will result because it would specify certain patents collection provisions in this final rule. in gains for two groups. It will reduce that must not be submitted, and thus An agency may not conduct or sponsor, pharmaceutical prices to consumers and NDA applicants and holders and patent and a person is not required to respond increase net revenues of generic drug owners will not submit information on to, a collection of information unless it manufacturers. Earlier competition also

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will result in a revenue loss for patent declaration forms. Finally, those over 10 years. We have chosen this time innovator drug companies, which will NDA holders wishing to submit patents period because the Centers for Medicare be offset slightly by a reduction in claiming different polymorphs of the and Medicaid Services (CMS), the associated costs. We believe that the active ingredient described in the NDA source of the most reliable rule will also reduce legal fees will need to have test data pharmaceutical expenditure estimates, associated with disputed patents, demonstrating ‘‘sameness.’’ Table 2 projects these expenditures only for the although we are unable to provide below provides a summary of our next 10 years. We expect that this rule quantitative estimates of this effect. In estimates of these effects and overall net will generate substantial net benefits addition, innovator drug companies will benefits. The benefits and costs are beyond this time period. face a burden of completing revised annualized at a 7-percent discount rate

TABLE 2.—ECONOMIC EFFECTS OF THE RULE1

Effects Amount per year (millions of dollars)

Gains •Savings to consumers 3,290 • Net revenues to generic manufactures 1,810 •Reduced legal costs Not quantified

Losses • Revenue loss to innovator firms (net of associated costs) 4,870 • Costs of patent declarations and data to support polymorph patent submissions <10

Net Benefits 220 1 Gains and Losses include impacts of an economic transfer in addition to changes in resource costs.

These estimates are derived using polymorph testing and completing the increase. Also, to the extent that these methods and data similar to those revised declaration, so the rule is a net generic drugs are less expensive than described at more length in the benefit. These support costs are based innovator drugs, consumers will benefit preamble to the proposed rule on a point estimate provided by from saving money as a result of earlier published in the Federal Register on literature that does not customarily access. Our model, as described in the October 24, 2002 (see 67 FR 65448 at provide confidence intervals. We proposed rule (see 67 FR 65448 at 65460 65459 to 65464). In that analysis, we cannot, therefore, provide confidence to 65462), estimates costs and benefits found that the increase in revenues to intervals about our net benefit estimate, to consumers and innovators and generic drug manufacturers would be but believe the uncertainty to be small, generic drug firms for the first year the $19.117 billion over 10 years, or $1.8 relative to the projected net benefit. rule would be in effect. The projected billion per year if annualized assuming We received no comment on the changes in market shares and prices in a 7-percent discount rate. The benefit to analysis published with the proposal. the model are based on studies consumers would be $34.822 billion We continue to believe these estimates published in the economic literature over 10 years or an annualized $3.3 to be reasonable and include them in and by FDA. We then escalate the 1-year billion. We found that the reduction in the final rule. This final rule, however, estimates by the CMS—projected annual revenues to innovator firms would be contains provisions that differ from percentage increases in prescription mitigated somewhat by the reduction in what was in the proposed rule. To drug expenditures to obtain estimates marketing expenses and that the cost account for these provisions, we have for 10 years. This 10-year stream is then would be $51.508 billion over ten years, changed our analysis of the burden of annualized at a 7-percent discount rate or an annualized $4.9 billion. The 10- providing the information required for to obtain the annualized estimate. year net benefit is $2.356 billion, and completing the patent declaration and the annualized net benefit is we assess the impact of the requirement 1. Gains to Consumers approximately $220 million. that NDA applicants or holders or With respect to the changes in market patent owners submitting patents Generic drugs are cheaper than their shares, the gains to consumers and claiming different polymorphs of the innovator counterparts. As a generic generics equal the losses to innovators. active ingredient described in the NDA. drug gains market share and its price An uncertainty estimate on the cost side In all other major respects, however, our falls, consumers save more money. The would equal the uncertainty on the analysis is unchanged from the elimination of multiple 30-month stays benefit side of such a transfer and proposal, so we do not repeat here some per ANDA and 505(b)(2) applications would not affect our projection of net parts of our analysis that were described and earlier market entry by generic benefits. Our projection of net benefits in detail in the proposal (see 67 FR drugs will reduce consumer is driven by our estimate of support 65448 at 65459 to 65464). expenditures on pharmaceuticals. We costs. The primary economic impact of estimate that the 1-year savings to this action is a transfer from innovator B. Benefits of the Regulation consumers are projected to be $2.040 drug firms to consumers and generic We have identified two principal billion. We use the CMS pharmaceutical drug firms. But as innovator drug firms effects from the elimination of 30-month expenditure projections to escalate the face a decline in revenues, they will stays. These effects are impacts base year figure results in a 10-year save substantial resources used to associated with parties gaining in consumer savings estimate of $34.822 support their products. These support economic transfer. Generic drug billion for the final rule. Our annualized costs, which include marketing, manufacturers gain the market share lost benefit using a 7-percent discount rate advertising, and administration, by innovators. Generic revenues, is $3.288 billion, the same as the outweigh the costs associated with therefore, would be expected to proposed rule.

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2. Gains to the Generic Drug Industry for submitting patents that may complete patent declarations. The loss Innovator market share erosion is ultimately be found invalid. It logically in revenues to innovator drug accompanied by a gain in generic follows that the reduction in resources companies is part of an economic market share. We estimate the 1-year devoted to litigation would result in transfer, but is included in this analysis increase in revenues to be $1.120 savings to both innovator and generic with the resource costs associated with billion. Escalating this impact by the drug firms. this action. We summarize the revenue This final rule reduces the level of annual increases in pharmaceutical loss and we assess the costs associated uncertainty associated with drug expenditures yields a 10-year revenue with the declaration requirement. In marketing decisions. For example, the addition, we estimate the burden to gain of $19.117 billion. Our annualized final rule diminishes incentives industry from the requirement that, for impact using a 7-percent discount rate associated with submitting later-issued submission of patents claiming different is $1.805 billion. These estimates are the patents late in the patent life or polymorphs of the active ingredient same as in the proposed rule. exclusivity period of the product described in the NDA, there must be test 3. Benefits Not Quantified described in the NDA. Increasing the data demonstrating that a drug product predictability of the generic drug entry Many important benefits associated containing the polymorph will perform process reduces product introduction with this final rule are difficult to the same as the drug product described costs faced by generic drug firms. In the quantify. The benefits to consumers in the NDA. final rule, we are also addressing a In the proposed rule, we addressed from lower prices also involve favorable source of confusion over the submission potential concerns about the effect this secondary benefits from improved of polymorph patents for listing in the action may have on innovation. After access to less expensive drugs. While Orange Book. We believe that a more considering potential impacts, we the economic literature indicates predictable business environment concluded that any negative effect generic competition does not lead to benefits both innovator and generic drug would be minimal. As discussed in the significant overall increases in the firms. proposed rule, while the initial 30- quantity of drugs demanded, we Another important benefit of the final month stay is part of the balance struck nevertheless recognize this rule has rule involves the balance between in the Hatch-Waxman Amendments to favorable distributional effects for rewarding innovation and the reward innovation, the subsequent stays consumers who otherwise may not have availability of less expensive drugs. In are not part of this balance. According been able to afford some medications. striking this balance, we do not believe to the FTC report, most of the court Such a benefit is consistent with the that the Hatch-Waxman Amendments rulings examined by the FTC, which objective of improving access to intended to create the potential for NDA involved a subsequent 30-month stay, affordable quality healthcare. holders to obtain multiple 30-month found the underlying patent to be either Consumers with better access to stays to unduly delay generic invalid or not infringed. Extending affordable safe and effective therapies competitors. We believe this balance to market exclusivity through multiple are healthier and enjoy a higher quality be important, yet find the value difficult stays is a strategy that has become of life. to quantify. Nevertheless, in addressing popular in the last few years and is not By addressing multiple 30-month the issue of multiple 30-month stays, we a longstanding source of research stays, this final rule is removing a believe this action has the very valuable funding. Subsequent stays could barrier to entry for generic drug firms. benefit of preserving the balance struck actually hinder innovation through the In principle, the removal of a barrier to in the Hatch-Waxman Amendments. replacement effect, in that they provide entry would imply an increase in a disincentive for an NDA holder to economic efficiency. The existing 4. Total Benefits of the Regulation improve upon its own product. economic literature, however, indicates The total quantified benefits of this Moreover, to the extent that subsequent no significant increase in the quantity of final rule include the gains in generic 30-month stays might be associated with drugs demanded with generic entry, drug manufacturer revenues and increases in spending on research, these implying no gain in efficiency from the consumer savings from earlier access to increases do not necessarily improve removal of the barrier to entry. Thus, we less expensive pharmaceuticals. These social welfare (see 67 FR 65460). We do not quantify any efficiency gains in quantified gains to consumers and received no comment on our assessment our analysis. Nevertheless, this rule generic drug companies are the result of of the impact on innovation and encourages more and earlier market an economic transfer. The 1-year continue to believe it to be reasonable. entry by generic drug firms and may benefits to generic drug manufacturers 1. Innovator Revenue Loss impact consumption in a way not and consumers are $1.119 billion and captured by the economic literature. To $2.040 billion, respectively. Escalating As discussed in the analysis of that extent, we believe this rule has the these base year costs over 10 years impacts in the proposed rule, the potential to increase economic yields generic drug manufacturer elimination of multiple 30-month stays efficiency. revenue gains of $19.117 billion and per ANDA or 505(b)(2) application The costs of allocating legal resources consumer savings of $34.822 billion, for allows generic drugs to enter the market to defend patent protections are a total of $53.940 billion. The 10-year earlier. Upon entry, generic versions of substantial. We do not know the extent annualized benefits, using a 7-percent an innovator drug gradually lower their to which this final rule will reduce such discount rate, are $1.805 billion for prices and take market share from the costs, but by eliminating multiple 30- generic drug manufacturers and $3.288 innovator. With the loss of market share, month stays per ANDA and 505(b)(2) billion for consumers, for a total of innovator revenues are lower than they application, we are reducing the number $5.093 billion. would be had the innovator been of instances where innovator and allowed to use multiple 30-month stays generic drug firms would engage in such C. Costs of the Regulation to delay generic entry. In the analysis in litigation. Moreover, we believe that this In the proposed rule, we identified the proposed rule, we used data from rule will reduce litigation because it two sources of costs. Innovators lose instances where generics had been clarifies which patents must and must revenues from earlier generic blocked with multiple 30-month stays not be submitted and reduces incentives competition and innovators must and calculated the impact of a typical

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drug being blocked for a typical period estimated cost would be $992 ($55.14 $625,000. We believe the typical value of time. We estimated the 1-year loss in per hour x 18 hours) per event. The of a deterred polymorph patent to be innovator revenues to be $3.160 billion. burden on individual firms would substantially less than the cost of As discussed in the proposed rule, we depend on the number of declarations submission of the patent for listing, as believe that the negative impact on they submit. We estimate that the 1-year many of the patents have little value innovators from earlier generic burden for submitting patent declaration without the ability to delay generic competition will be mitigated somewhat forms is $293,000 ($992 per event x entry through multiple 30-month stays. by a reduction in required innovators’ 295.8 events). For this analysis, we assume such low value patents to be worth approximately costs. With earlier generic competition, 3. Cost of Submitting Polymorph Patents innovators will reduce marketing 20 percent of the cost of showing expenses. In the proposed rule, we We are requiring the submission of ‘‘sameness,’’ or $125,000. estimated the 1-year reduction in patent information for patents that claim We believe the annual number of support costs to be approximately $142 different polymorphs of the active polymorph patents that will be million. For the final rule, we estimate ingredient described in the NDA. NDA submitted for listing to be small, but we that the 1-year loss in revenues, after holders will now be able to submit these do not know with certainty. We adjusting for the reduction in support polymorph patents for listing in the reviewed a publicly available listing of costs, is $3.017 billion, the same as in Orange Book, as long as they have test NDAs in which an outside party had the proposed rule. data demonstrating that a drug product identified patents it judged to be containing the polymorph will perform polymorph patents. Of the 105 NDAs in 2. Declaration Costs the same as the drug product described the sample, there were 13 polymorph In the proposed rule, we used earlier in the NDA. patents. Applying that same ratio to the information collection data to estimate We cannot make a precise estimate of 107 expected NDAs per year, we there will be 124 annual patent the impact of these requirements, as estimate 13.2 (107 x 13 / 105) potential declarations by innovator firms. We costs can vary substantially depending polymorph patents to be submitted for now believe that the number of patents on the substance being tested, the listing per year. We assume that a submitted to us each year would better number of subjects required, the cost of polymorph patent will have a high estimate the annual number of patent raw materials, and other factors. As part potential value (greater than $625,000— declarations. For the years 1998 to 2002, of an unrelated study in 1998, we the midpoint of the testing cost the numbers of patents submitted to us commissioned a contractor, Eastern estimates) and be submitted, or will were 159, 205, 321, 280, and 268 Research Group (ERG) to estimate the have a low potential value ($125,000) respectively, for an annual average of cost of bioequivalence testing. We and not be submitted. With the 246. We understand that many of these believe the burden of demonstrating that elimination of multiple 30-month stays individual patents are included in a drug product containing the per ANDA or 505(b)(2) application, we multiple NDA submissions, so there polymorph will perform the same as the believe the number of high-value could be multiple declarations for a drug product described in the NDA to polymorph patents to be a subset of the single patent and this method could be similar to that of demonstrating number of total polymorph patents, and underestimate the number of bioequivalence. Our estimates include assume three-fourths of the potential declarations. From our review of both the cost of manufacturing the batch patents will not be submitted for listing. submissions, we believe the number of and the cost of conducting the Thus, we assume 3.3 (13.2 potential duplicate patent listings to be 20 bioequivalence testing. ERG found the patents x 0.25 likelihood of being high percent of the number of unique cost of performing such testing to be value) patents will be submitted for 3 patents. Therefore, we estimate 49.2 between $70,000 and $750,000. We listing at a 1-year cost of $2.06 million (246.6 x 20 percent) patent declarations believe the cost of showing ‘‘sameness’’ (3.3 patents x $625,000 cost per patent). will be multiple listings, and there will to be at the higher end of this range, and Likewise, we assume 9.9 (13.2 potential be 295.8 (246.6 + 49.2) annual patent estimate the burden to be between patents x 0.75 likelihood of being low declarations. We have created patent $500,000 and $750,000. The midpoint of value) patents will not be submitted declaration forms to make the this estimate is $625,000. (We did not each year. We estimate the 1-year cost submission of patent information less adjust the ERG estimates for inflation.) from the inability to submit these burdensome. The two forms, for filing We believe a firm’s decision to submit patents for listing to be $1.24 million with an NDA submission and upon or a polymorph patent for listing will (9.9 patents x $125,000 value of low- after NDA approval, will contain more depend on whether the expected value patent) and the 1-year burden information, but we have simplified the benefits to the firm from listing exceed associated with the test data format to make these easier to complete. the costs of showing ‘‘sameness.’’ We demonstrating ‘‘sameness’’ for In simplifying the forms, we believe our recognize that potential benefits from polymorph patents to be submitted for initial estimate of 24 additional hours listing polymorph patents may be listing is estimated to be $3.3 million per declaration to complete these forms reduced by the elimination in the final ($2.06 million + $1.24 million). rule of multiple 30-month stays in likely overstates the actual burden. To 4. Total Costs of the Regulation account for the simplification of the approval of ANDA or 505(b)(2) applications. Thus, the cost of The total costs of the final rule declaration process, we have lowered include the lost revenues to innovator the expected time required to complete demonstrating ‘‘sameness’’ would deter submitting patents for listing with firms from the erosion of market share, a patent declaration to 18 hours. mitigated by the decrease in support A regulatory affairs specialist could expected values less than approximately costs, the cost of completing a more perform the tasks associated with this detailed patent declaration, and the process. Based on the total average then adjusted for inflation at 1.58 percent (unadjusted CPI–U) and increased 40 percent to costs associated with the requirement hourly compensation of $55.142 the account for benefits. that test data exist demonstrating 3 Pharmaceutical Industry Cost Savings Through 2 The figure of $55.14 represents the hourly rate Use of the Scale-up and Post-Approval Change ‘‘sameness’’ in order to submit a for ‘‘lawyer’’ from the Bureau of Labor Statistics Guidance for Immediate Release Solid Oral Dosage polymorph patent for listing. The 2003 National Compensation Survey of $38.77, and Forms ( SUPAC–IR), prepared for FDA, 1998, p. 63. estimated 1-year loss in revenues from

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erosion of market share is $3.160 billion patent claiming different polymorphs of Authority: 21 U.S.C. 321, 331, 351, 352, and the reduction in support costs the active ingredient described in the 353, 355, 355a, 356, 356a, 356b, 356c, 371, would reduce this loss by $142 million. NDA needed to have test data 374, 379e. We estimate the 1-year cost of providing demonstrating that a drug product ■ 2. Section 314.52 is amended by the patent declaration information by containing the polymorph will perform redesignating paragraph (a)(3) as completing the patent declaration forms the same as the drug product described paragraph (a)(4) and by adding new is $293,000 and the cost associated with in the NDA. This requirement is similar paragraph (a)(3) to read as follows: polymorph patents is $3.3 million. to the requirement of establishing § 314.52 Notice of certification of invalidity Thus, we estimate the 1-year cost to bioequivalence. or noninfringement of a patent. innovator firms is $3.022 billion. We also considered using the current We recognize that in projecting the (a)*** system of patent declarations. This (3) This paragraph does not apply if future impact of this final rule, we must alternative was also rejected because the the applicant amends its application to account for changes in the market for pre-existing declaration information pharmaceuticals. The Office of the add a certification under may be insufficient to prevent NDA Actuary at CMS, projects that § 314.50(i)(1)(i)(A)(4) when the applicants and holders and patent expenditures on prescription application already contained a owners from submitting patents to us pharmaceuticals will increase certification under § 314.50(i)(1)(i)(A)(4) dramatically in the near future. As in that should not be submitted and listed to a patent unless: (i) The notice of the previous the proposed rule, we account for the under the act. The choices to require certification under § 314.50(i)(1)(i)(A)(4) projected growth in pharmaceutical tests demonstrating ‘‘sameness’’ for was withdrawn or changed to a expenditures by escalating our 1-year polymorph patents and the required estimate by the annual CMS projected patent information provided in the certification other than a certification growth in prescription drug patent declarations are particularly under § 314.50(i)(1)(i)(A)(4); and (ii) The 45-day period under section expenditures. We estimate the 10-year important in light of the fact that we lack the authority, expertise and 505(c)(3) of the act had not expired; and costs for the final rule are $51.584 (iii) No person receiving notice under billion. We annualized over the 10-year resources to evaluate patents submitted paragraphs (a)(1) and (a)(2) of this period at a 7 percent discount rate to determine whether they should be section had brought an action against yields to obtain a cost of $4.871 billion. listed in the Orange Book. the applicant for infringement of the D. Summary of Costs and Benefits F. Small Business Impact patent that was the subject of the We estimate the 10-year cost of this Unless the agency certifies that the withdrawn or changed certification final rule to be $51.584 billion and the rule is not expected to have a significant under § 314.50(i)(1)(i)(A)(4). annualized cost to be $4.871 billion. impact on a substantial number of small * * * * * The 10-year benefit of this final rule is entities, the Regulatory Flexibility Act, ■ 3. Section 314.53 is amended by estimated to be $53.940 billion and the as amended by SBREFA, requires revising paragraph (b) and paragraphs annualized benefit is $5.093 billion. agencies to analyze regulatory options (c)(1) through (c)(3) to read as follows: These benefit and cost figures include that would minimize any significant § 314.53 Submission of patent information. the estimated impacts of an economic economic impact of a rule on small transfer. Thus, the 10-year net benefit is entities. In the proposed rule, we * * * * * $2.356 billion and the annualized net certified that we believed the rule is not (b) Patents for which information benefit is $222 million. The quantified expected to have a significant impact on must be submitted and patents for benefits exceed the quantified costs. a substantial number of small entities, which information must not be Moreover, there are benefits that are as we did not know of any small submitted—(1) General requirements. difficult to quantify. These benefits innovator companies that use or would An applicant described in paragraph (a) include reduced costs of litigation and use multiple 30-month stays to block of this section shall submit the required more predictability in the business entry from generic competitors. We did information on the declaration form set environment. The benefits to consumers not receive comment on this forth in paragraph (c) of this section for also involve favorable secondary certification and we continue to believe each patent that claims the drug or a benefits, such as improved access to less that this final rule will not have a method of using the drug that is the expensive drugs. It also preserves the significant impact on a substantial subject of the new drug application or balance struck in the Hatch-Waxman number of small entities. amendment or supplement to it and Amendments. with respect to which a claim of patent List of Subjects in 21 CFR Part 314 infringement could reasonably be E. Regulatory Alternatives asserted if a person not licensed by the In creating this final rule, we Administrative practice and owner of the patent engaged in the considered several regulatory procedure, Confidential business manufacture, use, or sale of the drug alternatives, including not enacting this information, Drugs, Reporting and product. For purposes of this part, such rule. We rejected the alternative of not recordkeeping requirements. patents consist of drug substance (active enacting this final rule because under ■ Therefore, under the Federal Food, ingredient) patents, drug product the current situation, NDA holders and Drug, and Cosmetic Act and under (formulation and composition) patents, patent owners are able to use multiple authority delegated to the Commissioner and method-of-use patents. For patents 30-month stays to delay generic entry of Food and Drugs, 21 CFR part 314 is that claim the drug substance, the and frustrate the intent of the Hatch- amended as follows: applicant shall submit information only Waxman Amendments. We considered on those patents that claim the drug allowing the submission of polymorph PART 314—APPLICATIONS FOR FDA substance that is the subject of the patents for listing in the Orange Book APPROVAL TO MARKET A NEW DRUG pending or approved application or that without the required test data claim a drug substance that is the same demonstrating ‘‘sameness.’’ We rejected ■ 1. The authority citation for 21 CFR as the active ingredient that is the this alternative as we decided that a part 314 continues to read as follows: subject of the approved or pending

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application. For patents that claim a product; a statement of the (J) Information on whether the patent polymorph that is the same as the active specifications and analytical methods has been submitted previously for the ingredient described in the approved or for each component; a description of the new drug application; pending application, the applicant shall manufacturing and packaging (K) Information on whether the certify in the declaration forms that the procedures and in-process controls for expiration date is a new expiration date applicant has test data, as set forth in the drug product; such specifications if the patent had been submitted paragraph (b)(2) of this section, and analytical methods as are necessary previously for listing; demonstrating that a drug product to assure the identity, strength, quality, (L) Information on whether the patent containing the polymorph will perform purity, and bioavailability of the drug is a product-by-process patent in which the same as the drug product described product, including release and stability the product claimed is novel; in the new drug application. For patents data complying with the approved (M) Information on the drug substance that claim a drug product, the applicant product specifications to demonstrate (active ingredient) patent including the shall submit information only on those pharmaceutical equivalence and following: patents that claim a drug product, as is comparable product stability; and (1) Whether the patent claims the defined in § 314.3, that is described in (v) Comparative in vitro dissolution drug substance that is the active the pending or approved application. testing on 12 dosage units each of the ingredient in the drug product described For patents that claim a method of use, executed test batch and the new drug in the new drug application or the applicant shall submit information application product. supplement; only on those patents that claim (c) Reporting requirements—(1) (2) Whether the patent claims a indications or other conditions of use General requirements. An applicant polymorph that is the same active that are described in the pending or described in paragraph (a) of this ingredient that is described in the approved application. The applicant section shall submit the required patent pending application or supplement; shall separately identify each pending information described in paragraph (3) Whether the applicant has test or approved method of use and related (c)(2) of this section for each patent that data, described in paragraph (b)(2) of patent claim. For approved applications, meets the requirements described in this section, demonstrating that a drug the applicant submitting the method-of- paragraph (b) of this section. We will product containing the polymorph will use patent shall identify with specificity not accept the patent information unless perform the same as the drug product the section of the approved labeling that it is complete and submitted on the described in the new drug application corresponds to the method of use appropriate forms, FDA Forms 3542 or or supplement, and a description of the claimed by the patent submitted. 3542a. These forms may be obtained on polymorphic form(s) claimed by the Process patents, patents claiming the Internet at http://www.fda.gov by patent for which such test data exist; packaging, patents claiming metabolites, searching for ‘‘forms’’. (4) Whether the patent claims only a metabolite of the active ingredient; and and patents claiming intermediates are (2) Drug substance (active ingredient), (5) Whether the patent claims only an not covered by this section, and drug product (formulation or information on these patents must not intermediate; composition), and method-of-use (N) Information on the drug product be submitted to FDA. patents—(i) Original Declaration. For (2) Test Data for Submission of Patent (composition/formulation) patent each patent that claims a drug substance Information for Patents That Claim a including the following: (active ingredient), drug product Polymorph. The test data, referenced in (1) Whether the patent claims the (formulation and composition), or paragraph (b)(1) of this section, must drug product for which approval is method of use, the applicant shall include the following: being sought, as defined in § 314.3; and (i) A full description of the submit FDA Form 3542a. The following (2) Whether the patent claims only an polymorphic form of the drug information and verification is required: intermediate; substance, including its physical and (A) New drug application number; (O) Information on each method-of- chemical characteristics and stability; (B) Name of new drug application use patent including the following: the method of synthesis (or isolation) sponsor; (1) Whether the patent claims one or and purification of the drug substance; (C) Trade name (or proposed trade more methods of using the drug product the process controls used during name) of new drug; for which use approval is being sought manufacture and packaging; and such (D) Active ingredient(s) of new drug; and a description of each pending specifications and analytical methods as (E) Strength(s) of new drug; method of use or related indication and are necessary to assure the identity, (F) Dosage form of new drug; related patent claim of the patent being strength, quality, and purity of the (G) United States patent number, submitted; and polymorphic form of the drug issue date, and expiration date of patent (2) Identification of the specific substance; submitted; section of the proposed labeling for the (ii) The executed batch record for a (H) The patent owner’s name, full drug product that corresponds to the drug product containing the address, phone number and, if available, method of use claimed by the patent polymorphic form of the drug substance fax number and e-mail address; submitted; and documentation that the batch was (I) The name, full address, phone (P) Whether there are no relevant manufactured under current good number and, if available, fax number patents that claim the drug substance manufacturing practice requirements; and e-mail address of an agent or (active ingredient), drug product (iii) Demonstration of bioequivalence representative who resides or maintains (formulation or composition) or between the executed batch of the drug a place of business within the United method(s) of use, for which the product that contains the polymorphic States authorized to receive notice of applicant is seeking approval and with form of the drug substance and the drug patent certification under sections respect to which a claim of patent product as described in the NDA; 505(b)(3) and 505(j)(2)(B) of the act and infringement could reasonably be (iv) A list of all components used in §§ 314.52 and 314.95 (if patent owner or asserted if a person not licensed by the the manufacture of the drug product new drug application applicant or owner of the patent engaged in the containing the polymorphic form and a holder does not reside or have a place manufacture, use, or sale of the drug statement of the composition of the drug of business within the United States); product;

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(Q) A signed verification which states: and e-mail address of an agent or substance (active ingredient), the ‘‘The undersigned declares that this is an representative who resides or maintains approved drug product (formulation or accurate and complete submission of patent a place of business within the United composition) or approved method(s) of information for the NDA, amendment or States authorized to receive notice of use and with respect to which a claim supplement pending under section 505 of the patent certification under sections of patent infringement could reasonably Federal Food, Drug, and Cosmetic Act. This 505(b)(3) and 505(j)(2)(B) of the act and time-sensitive patent information is be asserted if a person not licensed by submitted pursuant to 21 CFR 314.53. I attest §§ 314.52 and 314.95 (if patent owner or the owner of the patent engaged in the that I am familiar with 21 CFR 314.53 and new drug application applicant or manufacture, use, or sale of the drug this submission complies with the holder does not reside or have a place product; requirements of the regulation. I verify under of business within the United States); (R) A signed verification which states: penalty of perjury that the foregoing is true (K) Information on whether the patent ‘‘The undersigned declares that this is and correct.’’; and has been submitted previously for the an accurate and complete submission of (R) Information on whether the new drug application; patent information for the NDA, applicant, patent owner or attorney, (L) Information on whether the amendment or supplement approved agent, representative or other authorized expiration date is a new expiration date under section 505 of the Federal Food, official signed the form; the name of the if the patent had been submitted Drug, and Cosmetic Act. This time- person; and the full address, phone previously for listing; sensitive patent information is number and, if available, the fax number (M) Information on whether the submitted pursuant to 21 CFR 314.53. I and e-mail address. patent is a product-by-process patent in attest that I am familiar with 21 CFR (ii) Submission of patent information which the product claimed is novel; 314.53 and this submission complies (N) Information on the drug substance upon and after approval. Within 30 with the requirements of the regulation. (active ingredient) patent including the days after the date of approval of its I verify under penalty of perjury that the application or supplement, the following: (1) Whether the patent claims the foregoing is true and correct.’’; and applicant shall submit FDA Form 3542 (S) Information on whether the for each patent that claims the drug drug substance that is the active ingredient in the drug product described applicant, patent owner or attorney, substance (active ingredient), drug agent, representative or other authorized product (formulation and composition), in the approved application; (2) Whether the patent claims a official signed the form; the name of the or approved method of use. FDA will person; and the full address, phone rely only on the information submitted polymorph that is the same as the active ingredient that is described in the number and, if available, the fax number on this form and will not list or publish and e-mail address. patent information if the patent approved application; (3) Whether the applicant has test (3) No relevant patents. If the declaration is incomplete or indicates data, described at paragraph (b)(2) of applicant believes that there are no the patent is not eligible for listing. this section, demonstrating that a drug relevant patents that claim the drug Patent information must also be product containing the polymorph will substance (active ingredient), drug submitted for patents issued after the perform the same as the drug product product (formulation or composition), date of approval of the new drug described in the approved application or the method(s) of use for which the application as required in paragraph and a description of the polymorphic applicant has received approval, and (c)(2)(ii) of this section. As described in form(s) claimed by the patent for which with respect to which a claim of patent paragraph (d)(4) of this section, patent such test data exist; infringement could reasonably be information must be submitted to FDA (4) Whether the patent claims only a asserted if a person not licensed by the within 30 days of the date of issuance metabolite of the active ingredient; and owner of the patent engaged in the of the patent. If the applicant submits (5) Whether the patent claims only an manufacture, use, or sale of the drug the required patent information within intermediate; product, the applicant will verify this the 30 days, but we notify an applicant (O) Information on the drug product information in the appropriate forms, that a declaration form is incomplete or (composition/formulation) patent FDA Forms 3542 or 3542a. shows that the patent is not eligible for including the following: * * * * * listing, the applicant must submit an (1) Whether the patent claims the acceptable declaration form within 15 approved drug product as defined in ■ 4. Section 314.95 is amended by days of FDA notification to be § 314.3; and redesignating paragraph (a)(3) as considered timely filed. The following (2) Whether the patent claims only an paragraph (a)(4) and by adding new information and verification statement intermediate; paragraph (a)(3) to read as follows: (P) Information on each method-of- is required: § 314.95 Notice of certification of invalidity (A) New drug application number; use patent including the following: or noninfringement of a patent. (B) Name of new drug application (1) Whether the patent claims one or sponsor; more approved methods of using the (a)*** (C) Trade name of new drug; approved drug product and a (3) This paragraph does not apply if (D) Active ingredient(s) of new drug; description of each approved method of the applicant amends its application to (E) Strength(s) of new drug; use or indication and related patent add a certification under (F) Dosage form of new drug; claim of the patent being submitted; § 314.94(a)(12)(i)(A)(4) when the (G) Approval date of new drug (2) Identification of the specific application already contained a application or supplement; section of the approved labeling for the certification under (H) United States patent number, drug product that corresponds to the § 314.94(a)(12)(i)(A)(4) to a patent issue date, and expiration date of patent method of use claimed by the patent unless: submitted; submitted; and (i) The notice of the previous (I) The patent owner’s name, full (3) The description of the patented certification under address, phone number and, if available, method of use as required for § 314.94(a)(12)(i)(A)(4) was withdrawn fax number and e-mail address; publication; or changed to a certification other than (J) The name, full address, phone (Q) Whether there are no relevant a certification under number and, if available, fax number patents that claim the approved drug § 314.94(a)(12)(i)(A)(4);

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(ii) The 45-day period under section patent that was the subject of the Dated: May 23, 2003. 505(j)(5)(B)(iii) of the act had not withdrawn or changed certification Mark B. McClellan, expired; and under § 314.94(a)(12)(i)(A)(4). Commissioner of Food and Drugs. (iii) No person receiving notice under * * * * * Dated: June 9, 2003. paragraphs (a)(1) and (a)(2) of this Tommy G. Thompson, section had brought an action against the applicant for infringement of the Secretary of Health and Human Services. [This appendix will not appear in the Code of Federal Regulations.] BILLING CODE 4160–01–S

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[FR Doc. 03–15065 Filed 6–12–03; 1:00 pm] BILLING CODE 4160–01–S

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Part IV

Nuclear Regulatory Commission 10 CFR Parts 170 and 171 Revision of Fee Schedules; Fee Recovery for FY 2003; Final Rule

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NUCLEAR REGULATORY 6041; Office of the Chief Financial generic and other regulatory costs not COMMISSION Officer, U.S. Nuclear Regulatory otherwise recovered through 10 CFR Commission, Washington, DC 20555– Part 170 fees. 10 CFR Parts 170 and 171 0001. II. Response to Comments RIN 3150–AH14 SUPPLEMENTARY INFORMATION: I. Background The NRC published the FY 2003 Revision of Fee Schedules; Fee II. Response to Comments proposed fee rule on April 3, 2003 (68 Recovery for FY 2003 III. Final Action FR 16374) to solicit public comment on IV. Voluntary Consensus Standards its proposed revisions to 10 CFR Parts AGENCY: Nuclear Regulatory V. Environmental Impact: Categorical 170 and 171. The NRC received 26 Commission. Exclusion comments dated on or before the close VI. Paperwork Reduction Act Statement ACTION: Final rule. of the comment period (May 5, 2003) VII. Regulatory Analysis and several additional comments SUMMARY: The Nuclear Regulatory VIII. Regulatory Flexibility Analysis IX. Backfit Analysis thereafter, for a total of 32 comments Commission (NRC) is amending the X. Small Business Regulatory Enforcement that were considered in this fee licensing, inspection, and annual fees Fairness Act rulemaking. The comments have been charged to its applicants and licensees. grouped by issues, and are addressed in I. Background The amendments are necessary to a collective response. implement the Omnibus Budget For FYs 1991 through 2000, OBRA– Reconciliation Act of 1990 (OBRA–90), 90, as amended, required that the NRC A. Legal Issues as amended, which requires that the recover approximately 100 percent of its Information Provided by NRC in NRC recover approximately 94 percent budget authority, less the amount Support of Proposed Rule of its budget authority in fiscal year (FY) appropriated from the U.S. Department 2003, less the amounts appropriated of Energy (DOE) administered NWF, by Comment. Several commenters urged from the Nuclear Waste Fund (NWF). assessing fees. To address fairness and the NRC to provide licensees and the The amount to be recovered for FY 2003 equity concerns raised by the NRC public with a more detailed explanation is approximately $526.3 million. related to charging NRC license holders of the activities and associated costs that form the basis for NRC’s fees. Some EFFECTIVE DATE: August 18, 2003. for agency budgeted costs that do not provide a direct benefit to the licensee, commenters stated that the NRC should ADDRESSES: The comments received and provide specific accounting of the major the agency work papers that support the FY 2001 Energy and Water Development Appropriations Act elements that comprise the annual fee, these final changes to 10 CFR Parts 170 including detailed information on the and 171 are available electronically at amended OBRA–90 to decrease the NRC’s fee recovery amount by 2 percent outstanding major contracts, their the NRC’s Public Electronic Reading purpose, and their costs. Other Room on the Internet at http:// per year beginning in FY 2001, until the fee recovery amount is 90 percent in FY commenters indicated that this www.nrc.gov/reading-rm/adams.html. information should also be available for From this site, the public can gain entry 2005. As a result, the NRC is required to recover approximately 94 percent of part 170 fees, claiming it is difficult to into the NRC’s Agencywide Documents understand exactly what is included in Access and Management System its FY 2003 budget authority, less the amounts appropriated from the NWF, the hourly rate. One of these (ADAMS), which provides text and commenters also stated that more image files of NRC’s public documents. through fees. In the Energy and Water Development Appropriation Act, 2003, detailed information on the total costs For more information, contact the NRC contained in the Consolidated associated with each component of Public Document Room (PDR) Reference Appropriations Resolution, 2003 (Pub. reactor regulation and all other generic staff at 1–800–397–4209, or 301–415– L. 108–7), Congress appropriated $584.6 costs would allow stakeholders to 4737, or by email to [email protected]. If you million to the NRC for FY 2003. This provide more effective feedback on the do not have access to ADAMS or if there sum includes $24.7 million efficiency of NRC’s regulatory activities are problems in accessing the appropriated from the NWF. The total and would propel the Commission to documents located in ADAMS, contact amount NRC is required to recover in exercise its authority to promote the PDR. fees for FY 2003 is approximately increased fiscal responsibility. Comments received may also be $526.3 million. Several commenters raised concerns viewed via the NRC’s interactive The NRC assesses two types of fees to that the NRC could not specifically rulemaking Web site (http:// meet the requirements of OBRA–90, as identify where resources are being ruleforum.llnl.gov). This site provides amended. First, license and inspection applied, as the agency identified the ability to upload comments as files fees, established in 10 CFR Part 170 approximately 76 percent of the NRC’s (any format), if your web browser under the authority of the Independent budget for recovery under part 171 and supports that function. For information Offices Appropriation Act of 1952 only 24 percent under the discrete fee about the interactive rulemaking site, (IOAA), 31 U.S.C. 9701, recover the provisions of part 170. These contact Ms. Carol Gallagher, 301–415– NRC’s costs of providing special commenters stated this meant that the 5905; e-mail [email protected]. benefits to identifiable applicants and NRC could only identify 24 percent of For a period of 90 days after the licensees. Examples of the services its expenditures as directly supporting effective date of this final rule, the work provided by the NRC for which these the licensees, and that neither NRC nor papers may also be examined at the fees are assessed are the review of industry management can determine NRC Public Document Room, Room O– applications for new licenses, and for whether applicable resources are being 1F22, One White Flint North, 11555 certain types of existing licenses, the applied to appropriate priorities in such Rockville Pike, Rockville, MD 20852– review of renewal applications, the a case. These commenters further stated 2738. review of amendment requests, and that the aggregation of a substantial FOR FURTHER INFORMATION CONTACT: Ann inspections. Second, annual fees portion of non-discrete expenditures to Norris, telephone 301–415–7807; or established in 10 CFR Part 171 under be recovered through part 171 fees Tammy Croote, telephone 301–415– the authority of OBRA–90, recover makes it virtually impossible for

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licensees to understand and comment were available during the public as general and administrative costs, on the appropriateness of these comment period to answer any such as rent, utilities, supplies, and expenditures, and that the NRC should questions that commenters had on the payroll and human resources staffs. revise parts 170 and 171 to discretely development of the proposed fees. No These hourly rates are not developed in allocate generic program costs to inquiries were received about the fee relation to one another but are based on individual dockets in order to improve development process. budgeted costs for the reactors program the visibility of management oversight With regard to the comments that and the materials program. Since the and associated accountability of these expressed concern that too much of the budgeted costs are different for each programs. NRC’s budget was designated for program, different rates result. These Response. Consistent with the recovery under part 171, the NRC notes rates do not necessarily track with requirements of OBRA–90, as amended, that it has taken action to increase the private sector rates, nor should they be the purpose of this rulemaking is to amount recovered under part 170, used as a benchmark for industry establish fees necessary to recover 94 consistent with existing Federal law and standards. Instead, these rates reflect the percent of the NRC’s FY 2003 budget policy. For example, in FY 1998 the budgeted costs of the reactors and authority, less the amounts appropriated agency began charging part 170 fees for materials programs. from the NWF, from the various classes resident inspectors and in FY 1999 the A major reason for the four percent of licensees. The efficiencies of NRC’s agency started charging part 170 fees for increase in the hourly rate for the regulatory activities and the manner in project manager activities associated materials program is the salary and which NRC carries out its fiscal with oversight of the assigned license or benefits increase resulting primarily responsibilities are outside the scope of plant. Additionally, in FY 2003 the NRC from the Government-wide pay raise. this rulemaking. The proposed rule amended its regulations to allow the While salary and benefits also increase described the types of activities agency to recover costs associated with similarly for the reactor program, the included in the proposed fees and contested hearings on licensing actions increase is offset by a reduction in the explained how the fees were calculated involving U.S. Government national average overhead cost per direct FTE for to recover the budgeted costs for those security initiatives through part 170 fees the reactor program. The hourly rates, activities. Therefore, the NRC believes assessed to the affected applicant or coupled with the direct contract costs, that ample information was available on licensee (67 FR 64033; October 17, recover through part 170 fees the full which to base constructive comments 2002). Included under this provision are cost to the NRC of providing special on the proposed revisions to parts 170 activities involving the fabrication and services to specifically identifiable and 171 and that its fee schedule utilization of mixed oxide fuel (MOX). beneficiaries as provided by the IOAA. development is a transparent process. The NRC assesses part 170 fees under The revised hourly rates plus direct In addition to the information the IOAA, and consistent with OMB contract costs recover, through part 171 provided in the proposed rule, the Circular A–25, to recover the costs annual fees, the required amount of supporting work papers were available incurred from each identifiable NRC’s budgeted costs for activities not for public examination in the NRC’s recipient for special benefits derived recovered through part 170 fees, as Agencywide Documents Access and from Federal activities beyond those mandated by OBRA–90, as amended. Management System (ADAMS) and, received by the general public. Generic The NRC is establishing in this final during the 30-day comment period, in costs that do not provide special rule the revised hourly rates necessary the NRC Public Document Room at One benefits to identifiable recipients can to accomplish the fee recovery White Flint North, 11555 Rockville not be recovered under part 170. requirements. For part 170 activities, the Pike, Rockville, MD. The work papers The NRC clearly sets forth the rates will be assessed for professional show the total budgeted full time components of these generic costs in its staff time expended on or after the equivalent (FTE) and contract costs at workpapers and how those costs are effective date of this final rule. the planned accomplishment level for recovered through annual fees. each agency activity. The work papers 2. Project Manager Billing Issues also include extensive information B. Specific Part 170 Issues Comment. Several commenters detailing the allocation of the budgeted expressed concern with the increase in 1. Increase in Hourly Rates costs for each planned accomplishment charges for Project Manager (PM) time to within each program of each strategic Comment. Several commenters raised uranium recovery licensees and other arena to the various classes of licenses, concerns with the proposed increase to materials licensees. Some of these as well as information on categories of $158 for the hourly rate for the materials commenters would like clarification of costs included in the hourly rate. program. One commenter stated that the status of the NRC’s Office of Nuclear The NRC has also made available in there seems to be no reason that the Materials Safety and Safeguards (NMSS) the Public Document Room NUREG– hourly rate for the materials program is policy change that was implemented in 1100, Volume 18, ‘‘Budget Estimates higher than the hourly rate for reactors. July 2001, which states that a PM’s costs and Performance Plan, Fiscal Year This commenter also thought that the are not billed to the licensee as part 170 2003’’ (February 2002), which discusses rates are out of line with rates paid by fees if that PM spends 75 percent or less the NRC’s budget for FY 2003, including industry for safety professionals and of his/her time in any two-week period the activities to be performed in each managers. on duties to support that licensee. Other strategic arena. This document is also Response. The NRC’s hourly rates are commenters said that after an initial available on the NRC public Web site at based on budgeted costs and must be drop in part 170 charges for PM duties http://www.nrc.gov/reading-rm.html. established at the revised levels each to uranium recovery licensees, these The extensive information available to year to meet the fee recovery charges had increased recently even the public meets all legal requirements requirements. The hourly rates include though duties related to the sites had and the NRC believes it has provided not only average salaries and benefits not changed, and stated that PM time the public with sufficient information for professional employees, but also a should not be charged to part 170 fees, on which to base their comments on the prorated share of overhead costs, such whenever possible. Some commenters proposed fee rule. Additionally, the as supervisory, secretarial, and thought the Commission should reduce contacts listed in the proposed fee rule information technology support, as well the impact of the hourly rate increase on

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uranium recovery licensees by doing and counterproductive to regulatory activities whose costs are recovered everything possible to reduce the efficiency and effectiveness. In through part 171 annual fees. amount of time spent by staff working particular, this commenter stated that The NRC does not believe its fee on licensing issues related to uranium NRC’s fee waiver policy is not waiver policy discourages cooperative recovery licenses. They suggested that consistent with the definitions of part efforts between the agency and industry, this could be accomplished through the 170 and part 171 fees as described in the and that its assessment of part 170 fees streamlining of the regulatory process, FY 2003 proposed fee rule. The for a special project is fully consistent including delegating regulation of in- commenter stated that the Office of the with the NRC’s policies on industry situ leach wellfields to the States Chief Financial Officer (OCFO) had initiatives. Under the existing fee waiver through Memoranda of Understanding been charging part 170 fees for criteria, NRC will waive the review fees and more reliance on Safety and documents that did not fall under the for a special project submitted for the Environmental Review Panels and description in the FY 2003 proposed fee purpose of supporting the agency’s performance based-licensing. rule of documents for which part 170 regulatory improvements as long as the Response. NMSS modified its policy fees should be assessed. This NRC staff agrees with the applicant at for project management fee billing commenter challenged as flawed the time of submission that it will be effective July 29, 2001. The modified various reasons that OCFO had used by the NRC in developing or policy states that an NRC employee previously given to deny fee waivers in improving its regulatory framework. The must spend more than 75 percent of his/ the past. The commenter advocated NRC encourages any special project her time in any two-week period cooperative efforts between NRC and applicant who believes that its proposal performing duties to support a facility’s industry, and expressed concern that will help improve NRC’s regulatory license or certificate review to be OCFO positions blocked this process to discuss its proposal with the considered a PM for full-cost fee billing cooperation. The commenter suggested cognizant NRC program office staff prior purposes (Full-cost fee billing causes a changing NRC’s fee waiver policy to to requesting a fee waiver from the Chief prorated portion of a PM’s indirect time eliminate disincentives for industry to Financial Officer. to be charged to the licensee. The be proactive in addressing generic C. Specific Part 171 Issues modified NMSS policy reduced the regulatory issues. number of PMs whose indirect time is Response. The NRC did not propose 1. Annual Fees vs. Hourly Fees billed to the licensee.). The NRC has not to revise its policy for those services changed that policy, nor how it is being Comment. One commenter stated that implemented. The FY 2003 proposed which part 170 fees are assessed, nor the it prefers annual fees to hourly fees, fee rule did not propose to change the existing fee waiver policy in this since it is easier to plan and allocate NMSS PM fee billing policy, so there rulemaking. The proposed rule’s resources related to annual fees, while was no need for the proposed rule to description of purposes for which part hourly fees are more unpredictable and address its implementation status. If 170 fees would apply is intended to be more difficult to incorporate into a licensees have specific questions about illustrative, not exhaustive. The NRC licensee’s financial plan. Some particular invoices, they may request clarified its fee waiver policy in the FY commenters complained, however, that more details from the NRC and the staff 2002 final fee rule (67 FR 42612; June a disproportionate amount of the budget will provide additional information. 24, 2002), and responded extensively to is recovered through annuals fees. This has always been an option comments similar to the one Response. While the NRC appreciates available to licensees and applicants summarized above in the Response to the concerns raised by this commenter, who feel they need more information on Comments section of that final rule. The the agency notes that its collection of the costs billed. Commission’s position with respect to part 170 fees is consistent with Federal The NRC only charges fees to uranium its existing fee waiver policy has not law. The NRC assesses part 170 fees recovery (or any other) licensees based changed. In brief, the NRC has under the IOAA, which allows Federal on its budgeted costs. Regarding the consistently applied its policy of agencies to assess fees to recover costs comments suggesting that staff time waiving the part 170 fees for a special incurred in providing special benefits to devoted to regulating uranium recovery project submitted to the NRC for the identifiable recipients. In addition, the facilities should be reduced, the NRC purpose of supporting ‘‘NRC’s’’ generic Conference Report accompanying notes that the manner in which NRC regulatory improvements, and assessing OBRA–90 specifically states that the carries out its regulatory responsibilities part 170 fees for the review of a special Conference Committee ‘‘* * * expects is not addressed in this final rule, since project that is submitted for other the NRC to continue to assess fees under this issue is outside the scope of this purposes, including those that support the [IOAA] to the end that each licensee rulemaking. Nonetheless, the ‘‘industry’’ generic improvements. The or applicant pays the full cost to the Commission strives to ensure that all of NRC finds no justification for granting a NRC of all identifiable regulatory its efforts are needed to carry out its part 170 fee waiver, as the comment services such licensee or applicant health, safety, common defense and suggests, whenever a nuclear industry receives’’ (136 Cong. Rec. H12692–3, security responsibilities and frequently organization submits a proposal for daily ed. October 26 1990). The NRC has modifies its regulatory regime to reduce generic regulatory improvement. Fee received additional direction on this unnecessary burden on the regulated waivers will be granted only if the NRC issue in the Office of Management and community. Concerns about specific determines the submission will be used Budget (OMB) Circular A–25, in which licensee review efforts conducted by the for NRC’s generic regulatory OMB states it is Federal policy that a staff should be directed to the improvements, and the initiative was user charge will be assessed against appropriate program office. submitted specifically for that purpose. each identifiable recipient for special Thus, fee waivers are only appropriate benefits derived from Federal activities 3. Fee Waivers for Special Projects where the NRC’s review of the industry beyond those received by the general Comment. One commenter raised a initiative is part of the process of public. The NRC abides by this number of concerns with NRC’s fee developing the NRC’s generic regulatory direction in charging part 170 fees to waiver policy. This commenter stated program, and the review activities are recover the costs of providing special that this policy is flawed, unworkable, similar to other NRC generic regulatory benefits to identifiable recipients.

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Further, the NRC notes that, as required first implemented, that it recognizes the OBRA–90 requirement to recover most by OBRA–90, the part 171 annual fee assessment of fees to recover the of the agency’s budget authority through recovery amounts are offset by the agency’s costs may result in a fees. While establishing additional tiers estimated part 170 fee collections. As substantial financial hardship for some would provide further fee relief to some explained above, the NRC is not at licensees. However, consistent with the small entities, it would result in an liberty to allocate fees indiscriminately OBRA–90 requirement that annual fees increase of the small entity subsidy paid between parts 170 and 171, as statute must have, to the maximum extent by other licensees. The NRC must controls fee allocation. This applies practicable, a reasonable relationship to maintain a reasonable balance between both to comments that more of the the cost of providing regulatory services, the provisions of OBRA–90 and the RFA budget should be shifted from part 170 the NRC’s annual fees for each class of requirement that an agency must fees to part 171 as to the position license reflect the NRC’s budgeted cost examine ways to minimize significant advocating the reverse. of its regulatory services to the class. impacts that its rules may have on a The NRC determines the budgeted costs substantial number of small entities. 2. Annual Fees for Materials Users, to be allocated to each class of licensee Therefore, the NRC does not plan to Including Small Entities through a comprehensive review of modify its small entity fee structure, nor Comment. Two nuclear density gauge every planned accomplishment in each provide any further reduction in annual users commented that their fees are too of the agency’s major program areas. fees beyond that already established for high, and create a significant financial Furthermore, a reduction in the fees small entities. The NRC will re-examine burden on small business owners. One assessed to one class of licensees would the small entity fees again in FY 2005. of these users indicated only a small require a corresponding increase in the 3. Annual Fees for Uranium Recovery fraction of the company’s revenues was fees assessed to other classes. Licensees generated from NRC licensed activities, Accordingly, the NRC has not based its but that these activities are essential to annual fees on licensees’ economic Comment. The NRC received several support projects it designs and status, market conditions, or the comments regarding annual fees for monitors. With respect to the NRC’s inability of licensees to pass through the uranium recovery licensees. These upper fee level for small entities, this costs to its customers. Instead, the NRC comments supported the reduction in commenter stated that the broad has only considered the impacts that it annual fees for these facilities that revenue range encompassing $350,000 is required to address by law. resulted from the decision to rebaseline to $5,000,000 in gross annual receipts Based on the provisions of the FY 2003 annual fees. One commenter tends to favor larger firms while Regulatory Flexibility Act (RFA), the also supported the continued burdening smaller businesses. Thus, NRC provides reduced annual fees for implementation of last year’s they urge the NRC to consider adding licensees who qualify as small entities determination that the DOE must be more tiers for small businesses to reduce under the NRC’s size standards. The assessed one-half of all NRC budgeted the license fee burden on smaller materials users class has the most costs attributed to generic/other entities. The other commenter stated licensees who qualify for these reduced activities for the uranium recovery that license fees make it difficult for fees of any class. As such, the materials program. However, despite the proposed small projects to recover expenses, and users class receives the largest amount reductions, these commenters stated requested smaller fees. of annual fee reductions of any class. that there continues to be the lack of a Response. The NRC stated in the FY About 24 percent of these licensees reasonable relationship between the cost 2001 fee rule (66 FR 32452; June 14, (approximately 1,200 licensees) have to uranium recovery licensees of NRC’s 2001), that it would re-examine the requested small entity certification in regulatory program and the benefit small entity fee every two years, in the the past. The FY 2003 total estimated derived from such services. These same years in which it conducts the fee amount that will not be collected commenters believe there is excessive biennial review of fees as required by from licensees who pay reduced annual regulatory oversight by the NRC of the the Chief Financial Officer (CFO) Act of fees based on their small entity status is uranium recovery industry, especially 1990 (Pub. L. 101–578, November 15, approximately $4.5 million, which must in light of the NRC’s performance-based 1990, 104 Stat. 2838). Accordingly, as be collected from other NRC licensees in licensing approach, which they contend discussed in the FY 2003 proposed fee the form of a surcharge. Further should result in a reduced regulatory rule, this year the NRC re-examined the reductions in fees for materials users effort. The commenters assert that the small entity fees, and determined that would create an additional fee burden NRC should consider a more balanced no change to the small entity fee is on other licensees, thus raising fairness approach to uranium recovery warranted for FY 2003. The NRC last and equity concerns. regulation, resulting in less regulatory revised its small entity fees in FY 2000 As stated in 10 CFR 2.810, the NRC oversight and lower costs. (65 FR 36936; June 12, 2000), when it uses the Small Business Additionally, the commenters stated increased the small entity annual fee Administration’s (SBA) definition of that the NRC has failed to adequately and the lower tier small entity fee by 25 receipts. Based on the SBA definition, address the issue of decreasing numbers percent. For FY 2003, the NRC has revenue from all sources, not solely of uranium recovery licensees. determined that the current small entity receipts from NRC licensed activities, is Specifically, as more states become fees of $500 and $2,300 continue to considered in determining whether a Agreement States and/or additional sites meet the objective of providing relief to licensee qualifies as a small entity under are decommissioned, the number of many small entities while recovering the NRC’s revenue-based size standards. NRC regulated sites continues to from them some of the NRC costs The NRC believes that the two tiers of decline, leaving fewer licensees to pay associated with regulatory activities that reduced annual fees currently in place a larger share of the NRC’s regulatory benefit them. provide substantial fee relief for small costs. These commenters urged NRC to The NRC has addressed comments entities, including those with relatively continue its efforts to seek cost regarding the impact of fees on industry low annual gross revenues. As noted efficiencies through its annual reviews in previous fee rulemakings. The NRC previously, reductions in fees for small conducted as part of the budget process. has stated since FY 1991, when the 100 entities must be paid by other NRC One commenter stated that uranium percent fee recovery requirement was licensees in order to comply with the recovery licensees continue to be

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subject to unnecessary costs due to fully recover costs from certain classes Water Development Appropriations Act overlapping Federal or State agency of licensees due to caps or thresholds amended OBRA–90 to decrease the jurisdiction. The commenter stated that would result in other classes of NRC’s fee recovery amount by two in non-Agreement States, the NRC licensees bearing these costs. Combining percent per year beginning in FY 2001, should accept the groundwater quality fee categories would also have the until the fee recovery amount is 90 assessments conducted by the state or potential to increase the annual fees for percent in FY 2005. This decrease of six the Environmental Protection Agency certain licensees in the new combined percent in FY 2003 is applied to help rather than performing duplicative category to cover part of the cost for the offset the surcharge amount. environmental assessments. Several licensees whose fees were reduced by The annual fee for the power reactor commenters suggested that the agency this action. At this time, the class includes the agency’s homeland proceed expeditiously with extension of Commission is not prepared to adopt security costs related to power reactors the reactor oversight process for these any of these approaches. The NRC notes for this fiscal year, which significantly and other facilities as a risk-informed, that the annual fees for the Uranium contributed to the 15 percent increase in performance-based oversight process Recovery class decreased from FY 2001 power reactor fees. Additionally, the that recognizes the inherent safety of to FY 2002, and remained stable for FY increased workload for the new reactor these operations should further reduce 2003 due in part to the concerted efforts licensing activities contributed to the unnecessary regulatory burdens. by the program offices to reduce increase. Response. The NRC has responded to budgeted costs associated with this The agency workpapers supporting similar concerns raised by commenters program. However, the NRC recognizes both the proposed and final fee rules in several previous fee rulemakings. the concerns expressed and will show the budgeted costs for each First, in response to the specific continue its efforts to seek cost activity at the NRC’s planned suggestions about how the NRC should efficiencies and reduce regulatory accomplishment level, and the classes regulate these licensees or operate more burdens, without compromising its of licenses to which these costs are efficiently, the NRC again notes that the commitment to public health and safety. allocated. Furthermore, the workpapers purpose of this rule is to recover the show by class the total costs allocated, required percentage of its FY 2003 4. Annual Fees for Power Reactor and the estimated part 170 collections. budget authority, and that the manner in Licensees The annual fees are established to which the NRC carries out its regulatory Comment. One commenter stated that recover the difference between the activities is outside the scope of this there is insufficient basis to support the NRC’s total recoverable budgeted costs rulemaking. required costs to the power reactor (less the Nuclear Waste Fund) and the The NRC must assess annual fees to licensees for activities not directly estimated part 170 collections, in NRC licensees to recover the budgeted attributable or beneficial to their accordance with OBRA–90, as amended. costs not recovered through part 170 operation. Another commenter 5. Annual Fees for Fuel Facilities fees and other receipts. The NRC expressed concern about the 15 percent Licensees recognizes that this presents fairness increase in the operating power reactor and equity issues as costs must be annual fee, despite the two percent drop Comment. Several commenters recovered from licensees for activities in the agency’s overall recovery rate as expressed concerns with the annual fees that do not directly benefit them. To mandated by the FY 2001 Energy and for fuel facilities licensees. One address these fairness and equity Water Appropriations Act. Both commenter stated that these fees are concerns, as previously noted, the FY commenters raised fairness and equity unreasonably high and not in accord 2001 Energy and Water Development concerns regarding utilities paying for with NRC’s Strategic Plan: Fiscal Year Appropriations Act amended OBRA–90 agency activities that do not provide a 2000–Fiscal Year 2005. Other to decrease the NRC’s fee recovery direct benefit to them. commenters did not understand why amount by two percent per year Response. The part 171 power reactor there was a significant discrepancy beginning in FY 2001, until the fee annual fees are established to recover between the increase in annual fees for recovery amount is 90 percent in FY the costs for generic activities related to fuel fabricators (43 percent) in 2005. power reactors such as research, comparison to power reactors (15 The Commission is concerned about rulemakings and guidance development, percent), when much of the annual fee the issue of decreasing numbers of as well as costs for other activities for increase was attributed to the costs of licensees and its implications. Although the class not recovered through part 170 security-related activities and these a decreasing licensee base is only one of fees (e.g., allegations, most contested activities are similar for both types of several possible factors affecting annual hearings, special projects for which fee facilities. These commenters requested fees, it presents a clear dilemma for both waivers are granted, orders issued under that NRC review this discrepancy and the uranium recovery group in its efforts 10 CFR 2.202 or responses to such consider revisions to more equitably to maintain a viable industry, and the orders). The annual fees for each class allocate these costs. Another commenter NRC, which must by statute recover its also include a share of the total expressed concerns about the annual budgeted costs from the licensees it surcharge costs. The surcharge is fees for gaseous diffusion plants (GDPs), regulates. Potential remedies to this established to recover the costs for NRC stating that it did not believe that the problem involve establishing arbitrary activities that are not attributable to an annual fee for a GDP should be equal to fee caps or thresholds for certain classes existing NRC licensee or class of or more than the annual fee for a power of licensees, or combining fee licensees, such as activities that are reactor. This commenter suggested that categories. However, alternatives exempt from part 170 fees by law or NRC reevaluate its methodology to involving caps or thresholds, and Commission policy. The surcharge is establish the FY 2003 fees with the combining fee categories, also raise required in order for NRC to meet its objective of achieving a fee structure potential legal and fairness and equity statutory fee recovery requirements. To that is fair and equitable when viewed concerns. As noted previously, given address fairness and equity concerns in its entirety. Another commenter the requirements of OBRA–90, as related to charging NRC license holders stated that low enriched uranium fuel amended, to collect most of NRC’s for these expenses that do not directly facilities constitute a very small part of budget authority through fees, failure to benefit them, the FY 2001 Energy and the nuclear fuel cycle and pose only

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minimal risk, and that their facility annual fees for two classes (non-power and the fact that it has withstood this operated in a very competitive reactors and uranium recovery). For the scrutiny for many years continues to international market and so the small materials users and transportation lend support to the NRC’s confidence in magnitude of the fee increase represents classes, some categories of licensees will it as a robust tool in the fee a serious economic burden. The have increased annual fees and others development process. commenter asked that the proposed fees will have decreased annual fees. for fuel facilities be reviewed and that Regarding the comment that fees to Annual Fees for Spent Fuel Storage/ the amount of the increase be reduced fuel facilities represent an economic Reactor Decommissioning to a more reasonable level (on the order burden, since FY 1991 the Commission Comment. One commenter stated that of 10 percent) to be consistent with has consistently taken the position that other facilities and the general it will not consider economic factors the proposed 29.3 percent increase in increasing costs of NRC operations. when establishing fees, except for annual fees for spent fuel storage/reactor Response. The part 171 annual fees reduced fees provided for small entities decommissioning licensees is not for each class of licenses are established based on the policies reflected in the equitable and places an undue burden to recover the costs for generic activities Regulatory Flexibility Act. Granting fee on this particular class of licensees, related to that class of licenses, relief to the fuel facility licensees on the which do not generate revenue through including rulemakings and guidance basis of economic considerations could the sale of electricity and do not have development, as well as costs for other set an untenable precedent for the NRC a guarantee of recovering additional activities for the class not recovered with the potential to unravel the costs by petitioning local public utility through part 170 fees. The NRC believes stability and viability of the entire fee commissions. The commenter further this methodology is consistent with all system. Not only would other classes of stated that rapidly rising annual fee applicable laws, regulations, and licenses be required to subsidize fuel increases for spent fuel storage/reactor policies. Because the costs for one class facilities through increased fees, but decommissioning licensees place undue of licenses may increase or decrease at other categories of licensees may also budget constraints that could affect the different rates than the costs for other request similar treatment based on resources available for performing plant classes of licenses, fees for different analogous economic considerations. decommissioning activities. classes will increase or decrease at Thus, it would be difficult to develop a different rates accordingly. The NRC has rationale for waiving the fees for one Response. The NRC has responded to considered capping fee increases for class of licenses while denying similar similar comments in previous classes of licenses, but has not chosen requests from other NRC licensees rulemakings. Annual fees for the classes to do so for potential legal and fairness which may also be experiencing of licenses are based on the budgeted and equity reasons. economic downturns. costs for the classes, as well as a The NRC appreciates the concerns The annual fees for the fuel facility surcharge to recover the costs for NRC raised about fee predictability and class reflect increased budgeted costs for activities that are not attributable to an stability. In order to recover its budgeted activities that are not subject to cost existing NRC licensee or class of annual costs in compliance with the recovery under part 170, primarily licensee, including activities that are OBRA–90, as amended, the NRC homeland security activities related to exempt from part 170 fees by law or annually promulgates a rule establishing fuel facilities. Such activities include Commission policy. Since budgeted licensee fees. In light of concerns about the issuance and follow-up of orders costs for one class of licenses may rise annual fluctuations in these fees, the directing the fuel facility licensees to or fall at different rates than for other NRC announced in FY 1995 that annual take interim compensatory measures to classes of licenses, so will annual fees. fees would be adjusted only by the increase security, and a series of risk- The increase in annual fees for the spent percentage change (plus or minus) in informed vulnerability assessments the fuel storage/reactor decommissioning NRC’s total budget authority, adjusted NRC is conducting on fuel facilities. class of licensees reflects an increase in for changes in estimated collections for The NRC initially established a fuel budgeted costs allocated to this class 10 CFR Part 170 fees, the number of facility ‘‘effort/fee’’ matrix in the FY since FY 2002, including homeland licensees paying annual fees, and as 1995 fee rule (60 FR 32218; June 20, security activities that are on the fee 1995), further revising it in the FY 1999 otherwise needed to assure the billed base for FY 2003. Recovering the costs fee rule (64 FR 31448; June 10, 1999). amounts resulted in the required associated with spent fuel storage and collections. The NRC indicated that if The purpose of this matrix is to reactor decommissioning from operating there were a substantial change in the accurately reflect the NRC’s current power reactors, power reactors in total NRC budget authority or the costs of providing generic and other decommissioning or possession only magnitude of the budget allocated to a regulatory services to each type of fuel specific class of licenses, the annual fee facility. The matrix depicts the status if they have fuel on site, and base would be recalculated by categorization of licenses according to independent spent fuel storage part 72 rebaselining. Commission policy sets their activities, level, scope, depth of licensees who do not hold a part 50 the maximum interval between coverage, and rigor or generic regulatory license, is consistent with the intent of rebaselined fee schedules at three years. programmatic effort applicable to each OBRA–90 to assess annual fees to Based on the change in the magnitude facility category from a safety and licensees or classes of licenses, of the budget to be recovered through safeguards perspective. The relative commensurate with the expenditure of fees, the Commission determined that it weighted factors for each facility type the NRC’s resources. The Commission was appropriate to rebaseline its part for the various fee subclasses are believes it would be inequitable to grant 171 annual fees in FY 2003. depicted in Table VII. The matrix has fee relief to one class of licenses (except Rebaselining fees resulted in increased been quite valuable in helping the NRC to address small entity issues in annual fees compared to FY 2002 for assign appropriate fees for each type of accordance with the Regulatory four classes of licenses (power reactors, fuel facility. It is routinely available Flexibility Act) on the basis of economic spent fuel storage/reactor among the workpapers during the considerations, since this class would decommissioning, fuel facilities, and public comment process of each year’s then need to be subsidized by other rare earth facilities), and decreased rulemaking for revision of fee schedules classes of licenses.

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D. Other Issues In response to the comments that to recovery of these costs. The expressed concern regarding how the Commission has the authority to, but as 1. Security Costs NRC is expending homeland security a matter of policy does not, assess part Comment. The majority of comments funds, as stated previously, the NRC’s 170 fees for specific services rendered to did not support the NRC collecting budget and manner in which the agency an Agreement State. Agreement States security-related costs from licensees. carries out its activities are not within devote significant monetary and staff These commenters noted that the FY the scope of this rulemaking. resources to national radiation control 2003 NRC budget includes $29.3 million Nonetheless, the NRC is addressing the programs, and this effort assists the NRC for homeland security activities, and issues raised regarding the costs of and other Federal agencies in protecting stated that these activities should be vulnerability assessments and NRC’s public health and safety. The NRC costs funded through the General Treasury as relationship with the Department of for these Agreement State activities are part of the nation’s protection of critical Homeland Security. funded through a surcharge, which is infrastructure. Some of these allocated to the various license classes 2. NRC Budget commenters also stated that significant on a prorated basis. security costs are being incurred for Comment. Many commenters offered The surcharge is being funded from nuclear vulnerability assessments suggestions for reducing NRC’s budget the general fund of the U.S. Treasury as without due consideration of the and for more efficient/different use of a result of the FY 2001 Energy and evaluated threats or rigor of the NRC’s resources. Many of these Water Development Appropriations Act. methodology for conducting these comments addressed expenditures on This act amended OBRA–90 to decrease assessments, which is not the best way homeland security, while others the NRC’s fee recovery amount by 2 to allocate the nation’s resources in suggested more generally that NRC percent per year beginning in FY 2001, defending against terrorist attacks. Other reduce expenditures, streamline until the fee recovery amount is 90 commenters noted their belief that there processes, or otherwise perform percent in FY 2005, to address fairness is overlap and duplication of functions activities more efficiently. Commenters and equity concerns related to charging in Nuclear Security and Incident suggested that changes in NRC’s NRC license holders for agency Response with those of other Federal regulatory approach, such as the reactor budgeted costs that do not provide a agencies, particularly the Department of oversight process and risk-informed direct benefit to the licensee. The 2 Homeland Security. One comment changes to inspection, assessment, and percent per year reduction from the fee suggested that the increased fees for FY enforcement processes, should result in base accounts for activities such as 2003 did not appear to reflect a reduced fees. One commenter suggested Agreement State Oversight and consideration for the substantial work that increased cooperation between the Agreement State Regulatory Support. and engineered solutions that have NRC and industry could increase 4. Fee Increase Communication and already been implemented in the area of efficiency and conservation of limited Timing security. resources. Response. The NRC appreciates the Response. The NRC’s budgets and the Comment. Several commenters concerns raised by commenters with manner in which the NRC carries out its suggested that the NRC communicate regard to homeland security costs being activities are not within the scope of the potential magnitude of fee increases funded through licensee fees. The NRC this rulemaking. Therefore, this final earlier in the process. The commenters notes that the President’s FY 2003 rule does not address the commenters’ stated that this communication would budget requested that NRC’s funding for suggestions concerning the NRC’s allow licensees to forecast and mitigate homeland security activities be budget and the use of NRC resources. financial impacts. These commenters excluded from the fee base, as was the The NRC’s budget is submitted to the expressed disappointment that the NRC case in FY 2002. However, the Energy Office of Management and Budget and gave its licensees no warning that and Water Development Appropriations to Congress for review and approval. significant increases were being Act, 2003, contained in the The Congressionally-approved budget contemplated. Several commenters Consolidated Appropriations resulting from this process reflects the expressed concern that NRC fee Resolution, 2003 (Pub. L. 108–7), resources deemed necessary for NRC to increases are seen by licensees almost a included NRC’s budget for homeland carry out its statutory obligations. In year after their budgets have been security activities in the fee base. compliance with OBRA–90, the fees are initially set, and suggested that NRC Therefore, the FY 2003 fees must established to recover the required shift its process by one year (e.g., the include the $29.3 million budgeted for percentage of the approved budget. 2003 fee collection would be the 2004 NRC’s homeland security activities. The fee projection). One commenter Commission agrees there are merits to 3. Cost Recovery for Agreement State specifically requested that NRC review the arguments that licensees should be Activities and forecast ongoing costs and fees over treated in the same fashion as other Comment. One commenter stated that the next five years so that licensees can owner/operators of critical it supported the approach to allocate make accurate business forecasts. One infrastructure that do not generally pay Agreement State Program activities to commenter stated that NRC’s method of user fees for Federal agency homeland user fees, rather than the General Fund. collecting retroactive fees during the last security costs. The NRC notes that S. Another commenter suggested the government quarter for the previous 1043, the ‘‘Nuclear Infrastructure opposite approach, and stated that the three quarters will create a significant Security Act of 2003,’’ recently costs for activities like Agreement State and unanticipated negative financial approved by the Senate Committee on Programs should not be allocated to user impact. Environment and Public Works, fees, but rather paid for from the Response. The NRC appreciates the provides that amounts appropriated to General Fund. concerns raised by these commenters. the NRC for homeland security activities Response. The FY 2003 proposed fee However, as a matter of law (OBRA–90, would be excluded from the fee base rule did not propound to change how as amended) and policy the NRC must except for costs associated with the NRC recovers costs for Agreement collect the statutorily mandated level of fingerprinting, background checks and State Program activities, nor does this fees by the end of the fiscal year to security inspections. final rule make any changes with regard which they are attributed, in this case,

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September 30, 2003. The law also III. Final Action annual fees, compared to $345.6 million requires that these fees be established for FY 2002. through the rulemaking process. The The NRC is amending its licensing, A primary reason for the increase in NRC makes every effort to issue its inspection, and annual fees to recover total fees, as well as the annual fee approximately 94 percent of its FY 2003 proposed and final fee rules in a timely amount, for FY 2003 compared to FY budget authority, including the budget manner to afford licensees as much time 2002 is that the amount to be recovered authority for its Office of the Inspector as possible to plan for fee increases. for FY 2003 includes $29.3 million for General, less the appropriations However, the agency must ensure that it homeland security activities, whereas received from the NWF. The NRC’s total the FY 2002 funding for homeland fully complies with all applicable budget authority for FY 2003 is $584.6 legislation, regulations, and policies, as security was excluded from fees. While million, of which approximately $24.7 the President’s FY 2003 budget well as perform the required fee million has been appropriated from the calculations, in a relatively short time requested that NRC’s funding for NWF. Based on the 94 percent fee homeland security activities continue to each year to produce its fee rules. This recovery requirement, the NRC must be excluded from the fee base, the year Congress did not enact NRC recover approximately $526.3 million in Energy and Water Development appropriations for FY 2003 until FY 2003 through part 170 licensing and Appropriations Act, 2003, contained in February 20, 2003. Because the NRC inspection fees, part 171 annual fees, the Consolidated Appropriations does not know in advance what its and other offsetting receipts. The total Resolution, 2003 (Pub. L. 108–7), future budgets will be (i.e., proposed amount to be recovered through fees included NRC’s budget for homeland budgets must be submitted to the Office and other offsetting receipts for FY 2003 security activities in the fee base. of Management and Budget for its is $46.8 million more than the amount Therefore, the FY 2003 fees include the review before the President submits the estimated for recovery in FY 2002. $29.3 million budgeted for NRC’s budget to Congress for enactment), the The NRC estimates that homeland security activities. Other agency believes it is not practicable to approximately $127.5 million will be reasons for the fee increases include the set fees based on future estimated recovered in FY 2003 from part 170 fees 2003 Federal pay raise, and the budgets, nor would such an approach be and other offsetting receipts. For FY increased workload for new reactor consistent with its statutory mandate. 2003, the NRC also estimates a net licensing activities and reactor license The NRC will continue to strive to issue adjustment of approximately $1.9 renewal. its fee regulations as early in the process million for FY 2003 invoices that the Table I summarizes the budget and fee as is practicable in order to give as NRC estimates will not be paid during recovery amounts for FY 2003. Due to much time as possible for licensees to the fiscal year, and for payments rounding, adding the individual plan for changes in fees. received in FY 2003 for FY 2002 numbers in the table may result in a invoices. The remaining $396.8 million total that is slightly different than the will be recovered through the part 171 one shown.

TABLE I.—BUDGET AND FEE RECOVERY AMOUNTS FOR FY 2003 [Dollars in millions]

Total Budget Authority ...... $584.6 Less NWF ...... ¥24.7

Balance ...... $559.9 Fee Recovery Rate for FY 2003 ...... × 94.0%

Total Amount to be Recovered For FY 2003 ...... $526.3 Less Carryover from FY 2002 ...... ¥0

Amount to be Recovered Through Fees and Other Receipts ...... $526.3 Less Estimated Part 170 Fees and Other Receipts ...... ¥127.5

Part 171 Fee Collections Required ...... $398.8 Part 171 Billing Adjustments:. Unpaid FY 2003 Invoices (estimated) ...... 2.4 Less Payments Received in FY 2003 for Prior Year Invoices (estimated) ...... ¥4.3

Subtotal ...... ¥1.9

Adjusted Part 171 Collections Required ...... $396.8

The FY 2003 final fee rule is a publication of the FY 2003 final rule. licensees whose license anniversary ‘‘major’’ final action as defined by the For these licensees, payment will be due date falls on or after the effective date Small Business Regulatory Enforcement on the effective date of the FY 2003 final of the final FY 2003 rule will be billed Fairness Act of 1996. Therefore, the rule. Those materials licensees whose for the annual fee at the FY 2003 annual NRC’s fees for FY 2003 will become license anniversary date during FY 2003 fee rate during the anniversary month of effective 60 days after publication of the falls before the effective date of the final the license, and payment will be due on final rule in the Federal Register. The FY 2003 rule will be billed for the the date of the invoice. NRC will send an invoice for the annual fee during the anniversary In accordance with its FY 1998 amount of the annual fee to reactors and month of the license at the FY 2002 announcement, the NRC has major fuel cycle facilities upon annual fee rate. Those materials discontinued mailing the final fee rule

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to all licensees as a cost-saving measure. Additionally, the NRC is revising fee benefits also increase for the reactor Accordingly, the NRC does not plan to category 15.A. of § 170.31 to cover all program, the increase is offset by a routinely mail the FY 2003 final fee rule categories of radioactive waste import reduction in the average overhead cost or future final fee rules to licensees. license applications and to revise per direct FTE. However, the NRC will send the final category 15.B. to remove the radioactive The method used to determine the rule to any licensee or other person waste import license applications. two professional hourly rates is as upon specific request. To request a The amendments are as follows: follows: a. Direct program FTE levels are copy, contact the License Fee and 1. Hourly Rates Accounts Receivable Branch, Division identified for the reactor program and of Accounting and Finance, Office of the The NRC is revising the professional the materials program (nuclear materials Chief Financial Officer, at 301–415– hourly rates for NRC staff time and nuclear waste programs). 7554, or e-mail us at [email protected]. The established in § 170.20. These rates are b. Direct contract support, which is NRC plans to publish the final fee rule based on the number of FY 2003 direct the use of contract or other services in in June 2003. In addition to publication program FTEs and the FY 2003 NRC support of the line organization’s direct in the Federal Register, the final rule budget, excluding direct program program, is excluded from the will be available on the Internet at support costs and NRC’s appropriations calculation of the hourly rates because http://ruleforum.llnl.gov for at least 90 from the NWF. These rates are used to the costs for direct contract support are days after the effective date of the final determine the part 170 fees. The rate for charged directly through the various rule. the reactor program is $156 per hour categories of fees. The NRC is amending 10 CFR Parts ($276,661 per direct FTE). This rate is c. All other program costs (e.g., 170 and 171 as discussed in Sections A applicable to all activities for which fees Salaries and Benefits, Travel) represent and B below. are assessed under § 170.21 of the fee ‘‘in-house’’ costs and are to be collected regulations. The rate for the materials by dividing them uniformly by the total A. Amendments to 10 CFR Part 170: program (nuclear materials and nuclear number of direct FTEs for the program. Fees for Facilities, Materials, Import and waste programs) is $158 per hour In addition, salaries and benefits plus Export Licenses, and Other Regulatory ($280,876 per direct FTE). This rate is contracts for non-program direct Services Under the Atomic Energy Act applicable to all activities for which fees management and support, and for the of 1954, as Amended are assessed under § 170.31 of the fee Office of the Inspector General, are The NRC is revising the hourly rates regulations. In the FY 2002 final fee allocated to each program based on that used to calculate fees and is adjusting rule, the reactor and materials program program’s direct costs. This method the part 170 fees based on the revised rates were $156 and $152, respectively. results in the following costs which are hourly rates and the results of the A major reason for the 4 percent included in the hourly rates. Due to agency’s biennial review of fees increase to the materials program rate is rounding, adding the individual required by the Chief Financial Officer the salary and benefits increase that numbers in the table may result in a (CFO) Act of 1990 (Pub. L. 101–578, results primarily from the Government- total that is slightly different than the November 15, 1990, 104 Stat. 2838). wide pay raise. While salary and one shown.

TABLE II.—FY 2003 BUDGET AUTHORITY TO BE INCLUDED IN HOURLY RATES

Reactor Materials program program

Direct Program Salaries & Benefits (millions) ...... $134.1 $34.4 Overhead Salaries & Benefits, Program Travel and Other Support (millions) ...... 62.3 17.1 Allocated Agency Management and Support (millions) ...... 118.5 31.1

Subtotal (millions) ...... $314.9 $82.6 Less offsetting receipts (million) ...... ¥0 .1 ¥0.00

Total Budget Included in Hourly Rate (millions) ...... $314.8 $82.6

Program Direct FTEs ...... 1138.0 294.1 Rate per Direct FTE ...... $276,661 $280,876 Professional Hourly Rate (Rate per direct FTE divided by 1,776 hours) ...... $156 $158

As shown in Table II, dividing the Commercial Activities.’’ Similarly, 2. Fee Adjustments $314.8 million budgeted amount dividing the $82.6 million budgeted (rounded) included in the hourly rate amount (rounded) included in the The NRC is adjusting the current part for the reactor program by the reactor hourly rate for the materials program by 170 fees in §§ 170.21 and 170.31 to reflect both the revised hourly rates and program direct FTEs (1138.0) results in the program direct FTEs (294.1) results the results of the biennial review of part a rate for the reactor program of in a rate of $280,876 per FTE for FY 170 fees required by the CFO Act. To $276,661 per FTE for FY 2003. The 2003. The Direct FTE Hourly Rate for comply with the requirements of the Direct FTE Hourly Rate for the reactor the materials program is $158 per hour CFO Act, the NRC has evaluated program is $156 per hour (rounded to (rounded to the nearest whole dollar). historical professional staff hours used the nearest whole dollar). This rate is This rate is calculated by dividing the calculated by dividing the cost per to process a new license application for cost per direct FTE ($280,876) by the direct FTE ($276,661) by the number of those materials licensees whose fees are productive hours in one year (1,776 number of productive hours in one year based on the average cost method, or hours) as set forth in the revised OMB (1,776 hours). ‘‘flat’’ fees. This review also included Circular A–76, ‘‘Performance of new license and amendment

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applications for import and export follows: fees under $1,000 are rounded accompanying the FY 1995 fee rule (60 licenses. to the nearest $10, fees that are greater FR 32225; June 20, 1995), and further Evaluation of the historical data than$1,000 but less than $100,000 are explained in the statement of shows that fees based on the average rounded to the nearest $100, and fees considerations accompanying the FY number of professional staff hours that are greater than $100,000 are 1999 fee rule (64 FR 31448; June 10, required to complete licensing actions rounded to the nearest $1,000. 1999), determined that base annual fees in the materials program should be Applications filed on or after the will be re-established (rebaselined) at increased in some categories and effective date of the final rule will be least every third year, and more decreased in others to more accurately subject to the revised fees in this final frequently if there is a substantial reflect current costs incurred in rule. change in the total NRC budget or in the completing these licensing actions. The NRC is expanding fee Category magnitude of the budget allocated to a The data for the average number of 15.A. of § 170.31 to include all specific class of licenses. The fees were professional staff hours needed to categories of radioactive waste import last rebaselined in FY 2002. Based on complete new licensing actions was last license applications, and modifying the change in the magnitude of the updated in FY 2001 (66 FR 32452; June Category 15.B. of § 170.31 to exclude budget to be recovered through fees, the 14, 2001). Thus, the revised average these types of import license Commission has determined that it is professional staff hours in this fee rule applications. This change is being made appropriate to rebaseline the annual fees reflect the changes in the NRC licensing because all applications for the import again this year. Rebaselining fees will review program that have occurred of radioactive waste must be reviewed result in increased annual fees since FY 2001. by the Executive Branch and require the compared to FY 2002 for four classes of As a result of the biennial review, the involvement of all states and compacts, licenses (power reactors, spent fuel licensing fees that are based on the as well as extensive coordination within storage/reactor decommissioning, fuel average professional staff hours reflect the NRC. Therefore, the NRC efforts for facilities, and rare earth facilities), and an increase in average time for new the waste import license applications decreased annual fees for two classes license applications for six of the 33 are more closely aligned with the efforts (non-power reactors and uranium materials program fee categories, a for the other types of export and import recovery). For the small materials users decrease in average time for eight fee licenses currently covered by Category and transportation classes, some categories, and the same average time 15.A. categories of licenses will have for the remaining 19 fee categories. In addition, the Office of Nuclear increased annual fees and others will Similarly, the average time for Reactor Regulation revised its policy of have decreased annual fees. applications for new export and import charging the sites for administrative/ The annual fees in §§ 171.15 and licenses and for amendments to export overhead fees for early assignment of 171.16 will be revised for FY 2003 to and import licenses remained the same resident inspectors. Under this new recover approximately 94 percent of the for eight fee categories in §§ 170.21 and policy, the administrative/overhead fees NRC’s FY 2003 budget authority, less 170.31, and decreased for two other fee for the individuals selected for early the estimated amount to be recovered categories. assignments will not be charged to the through part 170 fees and the amounts The licensing fees for fee categories site. appropriated from the NWF. The total K.1 through K.5 of § 170.21, and fee In summary, the NRC is amending 10 amount to be recovered through annual categories 1C, 1D, 2B, 2C, 3A through CFR Part 170 to — fees for FY 2003 is $396.8 million, 3P, 4B through 9D, 10B, 15A through 1. Revise the materials and reactor compared to $345.6 million for FY 2002. 15E, and 16 of § 170.31 are based on the programs FTE hourly rates; Within the fee classes, the FY 2003 revised average professional staff hours 2. Revise the licensing fees to be annual fees will increase for many needed to process the licensing actions assessed to reflect the reactor and categories of licenses, decrease for other multiplied by the revised materials materials program hourly rates and to categories, and for two categories program professional hourly rate for FY comply with the CFO Act requirement remain the same from the previous year. 2003. that fees be reviewed biennially and The two largest categories of materials The biennial review also included the revised as necessary to reflect the cost licensees (which together include nearly ‘‘flat’’ fee for the general license to the agency; 3,500 of NRC’s approximately 4,900 registrations covered by fee Category 3. Revise Category 15.A. of § 170.31 to materials user licenses) show annual fee 3.Q. As a result of this review, the fee include radioactive waste import decreases compared to FY 2002 of 7.4 per registration is $620, compared to licenses, and exclude these types of percent and 9.8 percent. The increases $450 in FY 2002. The revised fee is applications from Category 15.B. in annual fees range from approximately based on the current estimated number 1.2 percent for DOE’s transportation of registrants, current annual resource B. Amendments to 10 CFR Part 171: activities to approximately 62 percent estimates for the program, and the FY Annual Fees for Reactor Licenses, and for licenses issued to distribute items 2003 materials program FTE rate. This Fuel Cycle Licenses and Materials containing byproduct material that increase to the current fee of $450 is Licenses, Including Holders of require device review to persons exempt based on experience with the Certificates of Compliance, from licensing requirements of part 30. registrations to date, which indicates Registrations, and Quality Assurance The decreases in annual fees range from that the average cost per registrant is Program Approvals, and Government approximately 2.7 percent for two higher than originally estimated. The Agencies Licensed by the NRC materials categories and for the quality next biennial review of the registration The NRC is revising the annual fees assurance approvals for users to fee will be included in the FY 2005 fee for FY 2003 as follows. approximately 53 percent for materials rule; however, the registration fee may licenses authorizing possession and use change in the FY 2004 fee rule if there 1. Annual Fees of byproduct material, source material, is a change to the materials program The NRC is establishing rebaselined and/or special nuclear material for well FTE rate for FY 2004. annual fees for FY 2003. The logging, well surveys, and tracer studies The amounts of the materials Commission’s policy commitment, (other than field flooding). The fees licensing ‘‘flat’’ fees are rounded as made in the statement of considerations remain the same for materials licenses

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authorizing possession and use of Factors affecting the changes to the the materials and waste program, and byproduct material in sealed sources for annual fee amounts include adjustments decreases in the numbers of licensees irradiation of materials where the source in budgeted costs for the different for certain categories of licenses. In is not removed from its shield and classes of licenses (including the addition, there is no carryover from FY licenses specifically authorizing the addition of budgeted costs for NRC’s 2002 to reduce the FY 2003 fees. The FY receipt of waste byproduct material, homeland security activities), the 2002 fees were reduced by a $1.7 source material, or special nuclear reduction in the fee recovery rate from million carryover from FY 2001. material from other persons for the 96 percent for FY 2002 to 94 percent for FY 2003, the estimated part 170 Table IV below shows the rebaselined purpose of packaging or repackaging the annual fees for FY 2003 for material. collections for the various classes of licenses, the increased hourly rate for representative categories of licenses.

TABLE IV.—REBASELINED ANNUAL FEES FOR FY 2003

FY 2003 an- Class/category of licenses nual fee

Operating Power Reactors (including Spent Fuel Storage/Reactor Decommissioning annual fee) ...... $3,251,000 Spent Fuel Storage/Reactor Decommissioning ...... 319,000 Nonpower Reactors ...... 63,300 High Enriched Uranium Fuel Facility ...... 5,836,000 Low Enriched Uranium Fuel Facility ...... 1,957,000 UF6 Conversion Facility ...... 839,000 Uranium Mills ...... 63,700 Transportation: Users/Fabricators ...... 76,200 Users Only ...... 7,100 Typical Materials Users: Radiographers ...... 12,200 Well Loggers ...... 4,700 Gauge Users ...... 1,900 Broad Scope Medical ...... 24,700

The annual fees assessed to each class and Water Appropriations Act which costs for these activities and the of licenses include a surcharge to amended OBRA–90 to decrease the reduction to the total surcharge amount recover those NRC budgeted costs that NRC’s fee recovery amount by 2 percent for fee recovery purposes are shown in are not directly or solely attributable to per year beginning in FY 2001, until the Table V. Due to rounding, adding the the classes of licenses, but must be fee recovery amount is 90 percent in FY individual numbers in the table may recovered from licensees to comply with 2005, the total surcharge costs for FY result in a total that is slightly different the requirements of OBRA–90, as 2003 will be reduced by about $33.6 than the one shown. amended. Based on the FY 2001 Energy million. The total FY 2003 budgeted

TABLE V.—SURCHARGE COSTS [Dollars in millions]

FY 2003 Category of costs budgeted costs

1. Activities not attributable to an existing NRC licensee or class of licensee: a. International activities ...... $10.3 b. Agreement State oversight ...... 8.8 c. Low-level waste disposal generic activities ...... 2.7 d. Site decommissioning management plan activities not recovered under part 170 ...... 3.6 2. Activities not assessed part 170 licensing and inspection fees or part 171 annual fees based on existing law or Commission policy: a. Fee exemption for nonprofit educational institutions ...... 6.7 b. Licensing and inspection activities associated with other Federal agencies ...... 2.9 c. Costs not recovered from small entities under 10 CFR 171.16(c) ...... 4.5 3. Activities supporting NRC operating licensees and others: a. Regulatory support to Agreement States ...... 13.4 b. Generic decommissioning/reclamation (except those related to power reactors) ...... 4.9

Total surcharge costs ...... 57.8 Less 6 percent of NRC’s FY 2003 total budget (less NWF) ...... ¥33.6

Total Surcharge Costs to be Recovered ...... $24.2

As shown in Table V, $24.2 million is various classes of licenses for FY 2003. surcharge costs, except Low-Level the total surcharge cost allocated to the The NRC will continue to allocate the Waste (LLW) surcharge costs, to each

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class of licenses based on the percent of licenses. The surcharge costs allocated Table VI. Due to rounding, adding the the budget for that class. The NRC will to each class will be included in the individual numbers in the table may continue to allocate the LLW surcharge annual fee assessed to each licensee. result in a total that is slightly different costs based on the volume of LLW The FY 2003 surcharge costs allocated than the one shown. disposed of by certain classes of to each class of licenses are shown in

TABLE VI.—ALLOCATION OF SURCHARGE

LLW surcharge Non-LLW surcharge Total sur- Percent $,M Percent $,M charge $,M

Operating Power Reactors ...... 74 2.0 79.3 17.1 19.1 Spent Fuel Storage/Reactor Decomm...... 8.2 1.8 1.8 Nonpower Reactors ...... 0.1 0.0 0.0 Fuel Facilities...... 8 0.2 6.7 1.4 1.6 Materials Users...... 18 0.5 3.8 0.8 1.3 Transportation ...... 1.2 0.3 0.3 Rare Earth Facilities ...... 0.2 0.0 0.0 Uranium Recovery ...... 0.7 0.1 0.1

Total Surcharge ...... 100 2.7 100.0 21.5 24.2

The budgeted costs allocated to each on the effort/fee determination matrix being subject to part 171 costs class of licenses and the calculations of established in the FY 1999 final fee rule applicable to the fee class, then the the rebaselined fees are described in a. (64 FR 31448; June 10, 1999). In the budgeted costs for the safety and/or through h. below. The workpapers matrix (which is included in the NRC safeguards components will be spread which support this final rule show in workpapers that are publicly available), among the remaining fuel facility detail the allocation of NRC’s budgeted licensees are grouped into five licensees/certificate holders, resulting in resources for each class of licenses and categories according to their licensed higher fees for those affected licensees. how the fees are calculated. The activities (i.e., nuclear material The methodology is applied as workpapers are available electronically enrichment, processing operations, and follows. First, a fee category is assigned at the NRC’s Electronic Reading Room material form) and according to the based on the nuclear material and on the Internet at Web site address level, scope, depth of coverage, and activity authorized by license or http://www.gov/reading-rm/ rigor of generic regulatory programmatic certificate. Although a licensee/ adams.html. For a period of 90 days effort applicable to each category from certificate holder may elect not to fully after the effective date of this final rule, a safety and safeguards perspective. utilize a license/certificate, the license/ the workpapers may also be examined at This methodology can be applied to certificate is still used as the source for the NRC Public Document Room located determine fees for new licensees, determining authorized nuclear material at One White Flint North, Room O– current licensees, licensees in unique possession and use/activity. Next, the 1F22, 11555 Rockville Pike, Rockville, license situations, and certificate category and license/certificate MD 20852–2738. holders. a. Fuel Facilities. The revised annual The methodology is adaptable to information are used to determine fees for the fuel facility class reflect changes in the number of licensees or where the licensee/certificate holder fits increased budgeted costs for activities certificate holders, licensed-certified into the matrix. The matrix depicts the that are not subject to cost recovery material/activities, and total categorization of licensees/certificate under part 170, primarily homeland programmatic resources to be recovered holders by authorized material types security activities related to fuel through annual fees. When a license or and use/activities, and the relative facilities. Such activities include the certificate is modified, it may result in generic regulatory programmatic effort issuance and follow-up of orders a change of category for a particular fuel associated with each category. The directing the fuel facility licensees to facility licensee as a result of the programmatic effort (expressed as a take interim compensatory measures to methodology used in the fuel facility value in the matrix) reflects the safety increase security, and a series of risk- effort/fee matrix. Consequently, this and safeguards risk significance informed vulnerability assessments the change may also have an effect on the associated with the nuclear material and NRC is conducting on fuel facilities. fees assessed to other fuel facility use/activity, and the commensurate The FY 2003 budgeted costs of licensees and certificate holders. For generic regulatory program (i.e., scope, approximately $27.0 million to be example, if a fuel facility licensee depth and rigor) level of effort. recovered in annual fees assessed to the amends its license/certificate in such a The effort factors for the various fuel facility class is allocated to the way (e.g., decommissioning or license subclasses of fuel facility licenses are individual fuel facility licensees based termination) that results in them not summarized in Table VII.

TABLE VII.—EFFORT FACTORS FOR FUEL FACILITIES

Effort factors Number of (In percent) Facility type facilities Safety Safeguards

High Enriched Uranium Fuel ...... 2 91 (36.0) 76 (57.1) Enrichment ...... 2 70 (27.7) 34 (25.6)

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TABLE VII.—EFFORT FACTORS FOR FUEL FACILITIES—Continued

Effort factors Number of (In percent) Facility type facilities Safety Safeguards

Low Enriched Uranium Fuel ...... 3 66 (26.1) 18 (13.5) UF6 Conversion ...... 1 12 (4.7) 0 (0) Limited Operations Facility ...... 1 8 (3.2) 3 (2.3) Others ...... 1 6 (2.4) 2 (1.5)

Applying these factors to the safety, class. The remaining surcharge, generic, (Class II facilities), and mill tailings safeguards, and surcharge components and other costs are assessed to the NRC disposal facilities (11e.(2) disposal of the $27.0 million total annual fee Title II program licensees that are facilities). Each of these categories amount for the fuel facility class results subject to annual fees. The costs to be benefits from the generic uranium in annual fees for each licensee within recovered through annual fees assessed recovery program efforts (e.g., the subcategories of this class to the uranium recovery class are shown rulemakings, staff guidance documents); summarized in Table VIII. below. Due to rounding, adding the (2) The matrix relates the category and individual numbers in the table may the level of benefit by program element TABLE VIII.—ANNUAL FEES FOR FUEL result in a total that is slightly different and subelement; FACILITIES than the one shown. (3) The two major program elements DOE Annual Fee Amount of the generic uranium recovery FY 2003 an- (UMTRCA Title I and Title II program are activities related to facility Facility type nual fee general licenses): operations and those related to facility UMTRCA Title I budgeted costs $393,227 closure; High Enriched Uranium Fuel .... $5,836,000 50% of generic/other uranium Uranium Enrichment ...... 3,634,000 recovery budgeted costs ...... 485,513 (4) Each of the major program Low Enriched Uranium ...... 1,957,000 50% of uranium recovery sur- elements was further divided into three UF Conversion ...... 839,000 6 charge ...... 70,829 subelements; Limited Operations Facility ...... 769,000 Others ...... 559,000 (5) The three major subelements of Total Annual Fee generic activities associated with Amount for DOE ...... 949,569 b. Uranium Recovery Facilities. The uranium facility operations are Annual Fee Amount for regulatory efforts related to the FY 2003 budgeted costs, including UMTRCA Title II Specific Li- surcharge costs, to be recovered through censes: operation of mills, handling and annual fees assessed to the uranium 50% of generic/other ura- disposal of waste, and prevention of recovery class is approximately $1.5 nium recovery budgeted groundwater contamination. The three million. Approximately $1.0 million of costs ...... 485,513 major subelements of generic activities this amount will be assessed to DOE. 50% of uranium recovery associated with uranium facility closure The remaining $0.5 million will be surcharge ...... 70,829 are regulatory efforts related to decommissioning of facilities and land recovered through annual fees assessed Total Annual Fee to conventional mills, in-situ leach clean-up, reclamation and closure of Amount for Title II tailings impoundments, and solution mining facilities, and 11e.(2) Specific Licenses ...... 556,342 mill tailings disposal facilities. groundwater clean-up. Weighted values Consistent with the change in The costs allocated to the various were assigned to each program element methodology adopted in the FY 2002 categories of Title II specific licensees and subelement considering health and final fee rule (67 FR 42612; June 24, are based on the uranium recovery safety implications and the associated 2002), the total annual fee amount, less matrix established in the FY 1999 final effort to regulate these activities. The the amounts specifically budgeted for fee rule (64 FR 31448; June 10, 1999). applicability of the generic program in Title I activities, is allocated equally The methodology for establishing part each subelement to each uranium between Title I and Title II licensees. 171 annual fees for Title II uranium recovery category was qualitatively This results in an annual fee being recovery licensees has not changed and estimated as either significant, some, assessed to DOE to recover the costs is as follows: minor, or none. specifically budgeted for NRC’s Title I (1) The methodology identifies three The relative weighted factors per activities plus 50 percent of the categories of licenses: conventional facility type for the various subclasses of remaining annual fee amount, including uranium mills (Class I facilities), specifically licensed Title II uranium the surcharge, for the uranium recovery uranium solution mining facilities recovery licensees are as follows:

TABLE IX.—WEIGHTED FACTORS FOR URANIUM RECOVERY LICENSES

Level of benefit total Number of Category weight Facility type facilities weight Value Percent

Class I (conventional mills) ...... 3 770 2,310 34 Class II (solution mining) ...... 6 645 3,870 58 11e.(2) disposal ...... 1 475 475 7 11e.(2) disposal incident to existing tailings sites ...... 1 75 75 1

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Applying these factors to the $0.5 costs is to be recovered through annual implementation of revised part 35, million in budgeted costs to be fees assessed to the non-power reactor Medical Use of Byproduct Material recovered from Title II specific licensees class of licenses for FY 2003. This (unique costs), has been allocated to results in the following revised annual amount is divided equally among the holders of NRC human use licenses. fees: four non-power reactors subject to The annual fee assessed to each annual fees. This results in a FY 2003 licensee also includes a share of the TABLE X.—ANNUAL FEES FOR TITLE II annual fee of $63,300 for each licensee. $800,000 in surcharge costs allocated to SPECIFIC LICENSES f. Rare Earth Facilities. The FY 2003 the materials user class of licenses and, budgeted costs of approximately for certain categories of these licenses, FY 2003 $187,000 for rare earth facilities to be a share of the approximately $500,000 Facility type annual recovered through annual fees will be in LLW surcharge costs allocated to the fee divided equally among the two class. The annual fee for each fee Class I (conventional mills) ...... $ 63,700 licensees who have a specific license for category is shown in § 171.16(d). Class II (solution mining) ...... 53,300 receipt and processing of source h. Transportation. Of the 11e.(2) disposal ...... 39,300 material. Prior to the beginning of FY approximately $5.0 million in FY 2003 11e.(2) disposal incidental to ex- 2003, one rare earth facility budgeted costs to be recovered through isting tailings sites ...... 6,200 permanently ceased operations and annual fees assessed to the requested that its license be amended to transportation class of licenses In the FY 2001 final rule (66 FR authorize decommissioning activities (including homeland security costs), 32478; June 14, 2001), the NRC revised only. Consequently, this license is no approximately $1.4 million will be § 171.19 to establish a quarterly billing longer subject to annual fees. The result recovered from annual fees assessed to schedule for the Class I and Class II is a FY 2003 annual fee of $93,600 for DOE based on the number of part 71 licensees, regardless of the annual fee each of the two remaining rare earth Certificates of Compliance that it holds. amount. Therefore, as provided in facilities. Of the remaining $3.6 million, § 171.19(b), if the amounts collected in g. Materials Users. To equitably and approximately 25 percent is allocated to the first three quarters of FY 2003 fairly allocate the $23.7 million in FY the 89 quality assurance plans exceed the amount of the revised annual 2003 budgeted costs to be recovered in authorizing use only and the 40 quality fee, the overpayment will be refunded; annual fees assessed to the assurance plans authorizing use and if the amounts collected in the first approximately 5,000 diverse materials design/fabrication. The remaining 75 three quarters are less than the final users and registrants, the NRC has percent is allocated only to the 40 revised annual fee, the remainder will continued to use the FY 1999 quality assurance plans authorizing use be billed after the FY 2003 final fee rule methodology to establish baseline and design/fabrication. This results in is published. The remaining categories annual fees for this class. The annual an annual fee of $7,100 for each of the of Title II facilities are subject to billing fees are based on the part 170 holders of quality assurance plans that based on the anniversary date of the application fees and an estimated cost authorize use only, and an annual fee of license as provided in § 171.19(c). for inspections. Because the application $76,200 for each of the holders of c. Power Reactors. The approximately fees and inspection costs are indicative quality assurance plans that authorize $305.0 million in budgeted costs to be of the complexity of the license, this use and design/fabrication. recovered through FY 2003 annual fees approach continues to provide a proxy 2. Small Entity Annual Fees assessed to the power reactor class, for allocating the generic and other which includes NRC’s budgeted costs regulatory costs to the diverse categories The NRC stated in the FY 2001 fee for homeland security activities related of licenses based on how much it costs rule (66 FR 32452; June 14, 2001), that to power reactors, is divided equally the NRC to regulate each category. The it would re-examine the small entity among the 104 power reactors licensed fee calculation also continues to fees every two years, in the same years to operate. This results in a FY 2003 consider the inspection frequency in which it conducts the biennial review annual fee of $2,932,000 per reactor. (priority), which is indicative of the of fees as required by the CFO Act. Additionally, each power reactor safety risk and resulting regulatory costs Accordingly, the NRC has re-examined licensed to operate will be assessed the associated with the categories of the small entity fees, and does not FY 2003 spent fuel storage/reactor licenses. The annual fee for these believe that a change to the small entity decommissioning annual fee of categories of licenses is developed as fees is warranted for FY 2003. The $319,000. This results in a total FY 2003 follows: revision to the small entity fees in FY annual fee of $3,251,000 for each power Annual fee = Constant × [Application 2000 (65 FR 36946; June 12, 2000) was reactor licensed to operate. Fee + (Average Inspection Cost divided based on the 25 percent increase in d. Spent Fuel Storage/Reactor by Inspection Priority)] + Inspection average total fees assessed to other Decommissioning. For FY 2003, Multiplier × (Average Inspection Cost materials licensees in selected budgeted costs of approximately $38.6 divided by Inspection Priority) + categories since the small entity fees million for spent fuel storage/reactor Unique Category Costs. were first established and changes that decommissioning are to be recovered The constant is the multiple necessary had occurred in the fee structure for through annual fees assessed to part 50 to recover approximately $18.0 million materials licensees over time. power reactors, and to part 72 licensees in general costs and is 1.18 for FY 2003. Unlike the annual fees assessed to who do not hold a part 50 license. The inspection multiplier is the other licensees, the small entity fees are Those reactor licensees that have ceased multiple necessary to recover not designed to recover the agency costs operations and have no fuel onsite are approximately $4.5 million in associated with particular licensees. not subject to these annual fees. The inspection costs for FY 2003, and is 0.92 Instead, the reduced fees for small costs are divided equally among the 121 for FY 2003. The unique category costs entities are designed to provide some licensees, resulting in a FY 2003 annual are any special costs that the NRC has fee relief for qualifying small entity fee of $319,000 per licensee. budgeted for a specific category of licensees while at the same time e. Non-power Reactors. licenses. For FY 2003, approximately recovering from them some of the Approximately $253,000 in budgeted $65,300 in budgeted costs for the agency’s costs for activities that benefit

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them. The costs not recovered from VII. Regulatory Analysis Pub. L. 101–508, the Omnibus Budget small entities for activities that benefit With respect to 10 CFR Part 170, this Reconciliation Act of 1990 (OBRA–90), them must be recovered from other final rule was developed pursuant to which required that, for FYs 1991 licensees. Given the reduction in annual Title V of the Independent Offices through 1995, approximately 100 fees and the relative low inflation rates, Appropriation Act of 1952 (IOAA) (31 percent of the NRC budget authority be the NRC has determined that the current U.S.C. 9701) and the Commission’s fee recovered through the assessment of small entity fees of $500 and $2,300 guidelines. When developing these fees. OBRA–90 was subsequently continue to meet the objective of guidelines the Commission took into amended to extend the 100 percent fee providing relief to many small entities account guidance provided by the U.S. recovery requirement through FY 2000. while recovering from them some of the Supreme Court on March 4, 1974, in The FY 2001 Energy and Water costs that benefit them. National Cable Television Association, Development Appropriations Act amended OBRA–90 to decrease the Therefore, the NRC is retaining the Inc. v. United States, 415 U.S. 36 (1974) NRC’s fee recovery amount by 2 percent $2,300 small entity annual fee and the and Federal Power Commission v. New per year beginning in FY 2001, until the $500 lower tier small entity annual fee England Power Company, 415 U.S. 345 fee recovery amount is 90 percent in FY for FY 2003. The NRC plans to re- (1974). In these decisions, the Court 2005. The NRC’s fee recovery amount examine the small entity fees again in held that the IOAA authorizes an agency for FY 2003 is 94 percent. To comply FY 2005. to charge fees for special benefits rendered to identifiable persons with this statutory requirement and in In summary, the NRC has— measured by the ‘‘value to the accordance with § 171.13, the NRC is 1. Established rebaselined annual fees recipient’’ of the agency service. The publishing the amount of the FY 2003 for FY 2003; meaning of the IOAA was further annual fees for reactor licensees, fuel cycle licensees, materials licensees, and 2. Retained the current reduced fees clarified on December 16, 1976, by four holders of Certificates of Compliance, for small entities. decisions of the U.S. Court of Appeals for the District of Columbia: National registrations of sealed source and IV. Voluntary Consensus Standards Cable Television Association v. Federal devices and QA program approvals, and Communications Commission, 554 F.2d Government agencies. OBRA–90, The National Technology Transfer 1094 (D.C. Cir. 1976); National consistent with the accompanying and Advancement Act of 1995, Pub. L. Association of Broadcasters v. Federal Conference Committee Report, and the 104–113, requires that Federal agencies Communications Commission, 554 F.2d amendments to OBRA–90, provides use technical standards that are 1118 (D.C. Cir. 1976); Electronic that— developed or adopted by voluntary Industries Association v. Federal (1) The annual fees be based on consensus standards bodies unless Communications Commission, 554 F.2d approximately 94 percent of the using such a standard is inconsistent 1109 (D.C. Cir. 1976); and Capital Cities Commission’s FY 2003 budget of $584.6 with applicable law or is otherwise Communication, Inc. v. Federal million less the amounts collected from impractical. In this final rule, the NRC Communications Commission, 554 F.2d part 170 fees and funds directly is amending the licensing, inspection, 1135 (D.C. Cir. 1976). The Commission’s appropriated from the NWF to cover the and annual fees charged to its licensees fee guidelines were developed based on NRC’s high level waste program; and applicants as necessary to recover these legal decisions. (2) The annual fees shall, to the approximately 94 percent of its budget The Commission’s fee guidelines were maximum extent practicable, have a authority in FY 2003 as is required by upheld on August 24, 1979, by the U.S. reasonable relationship to the cost of the Omnibus Budget Reconciliation Act Court of Appeals for the Fifth Circuit in regulatory services provided by the of 1990, as amended. This action does Mississippi Power and Light Co. v. U.S. Commission; and not constitute the establishment of a Nuclear Regulatory Commission, 601 (3) The annual fees be assessed to standard that contains generally F.2d 223 (5th Cir. 1979), cert. denied, those licensees the Commission, in its applicable requirements. 444 U.S. 1102 (1980). This court held discretion, determines can fairly, equitably, and practicably contribute to V. Environmental Impact: Categorical that— (1) The NRC had the authority to their payment. Exclusion recover the full cost of providing 10 CFR Part 171, which established annual fees for operating power reactors The NRC has determined that this services to identifiable beneficiaries; effective October 20, 1986 (51 FR 33224; final rule is the type of action described (2) The NRC could properly assess a September 18, 1986), was challenged in categorical exclusion 10 CFR fee for the costs of providing routine and upheld in its entirety in Florida 51.22(c)(1). Therefore, neither an inspections necessary to ensure a Power and Light Company v. United environmental assessment nor an licensee’s compliance with the Atomic States, 846 F.2d 765 (D.C. Cir. 1988), environmental impact statement has Energy Act and with applicable cert. denied, 490 U.S. 1045 (1989). been prepared for the final regulation. regulations; Further, the NRC’s FY 1991 annual fee By its very nature, this regulatory action (3) The NRC could charge for costs rule methodology was upheld by the does not affect the environment and, incurred in conducting environmental D.C. Circuit Court of Appeals in Allied therefore, no environmental justice reviews required by NEPA; (4) The NRC properly included the Signal v. NRC, 988 F.2d 146 (D.C. Cir. issues are raised. costs of uncontested hearings and of 1993). VI. Paperwork Reduction Act administrative and technical support VIII. Regulatory Flexibility Analysis Statement services in the fee schedule; (5) The NRC could assess a fee for The NRC is required by the Omnibus This final rule does not contain renewing a license to operate a low- Budget Reconciliation Act of 1990, as information collection requirements level radioactive waste burial site; and amended, to recover approximately 94 and, therefore, is not subject to the (6) The NRC’s fees were not arbitrary percent of its FY 2003 budget authority requirements of the Paperwork or capricious. through the assessment of user fees. Reduction Act of 1995 (44 U.S.C. 3501 With respect to 10 CFR Part 171, on This act further requires that the NRC et seq.). November 5, 1990, the Congress passed establish a schedule of charges that

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fairly and equitably allocates the facility or the procedures or PART 170—FEES FOR FACILITIES, aggregate amount of these charges organization required to design, MATERIALS, IMPORT AND EXPORT among licensees. construct, or operate a facility. LICENSES, AND OTHER This final rule establishes the REGULATORY SERVICES UNDER THE schedules of fees that are necessary to X. Small Business Regulatory ATOMIC ENERGY ACT OF 1954, AS implement the Congressional mandate Enforcement Fairness Act AMENDED for FY 2003. The final rule will result In accordance with the Small in increases in the annual fees charged ■ 1. The authority citation for part 170 Business Regulatory Enforcement to certain licensees and holders of continues to read as follows: certificates, registrations, and approvals, Fairness Act of 1996, Pub. L. 104–121, the NRC has determined that this action Authority: Sec. 9701, Pub. L. 97–258, 96 and decreases in annual fees for others. Stat. 1051 (31 U.S.C. 9701); sec. 301, Pub. L. Licensees affected by the annual fee is a major rule and has verified the 92–314, 86 Stat. 227 (42 U.S.C. 2201w); sec. increases and decreases include those determination with the Office of 201, Pub. L. 93–438, 88 Stat. 1242, as that qualify as a small entity under Information and Regulatory Affairs of amended (42 U.S.C. 5841); sec. 205a, Pub. L. NRC’s size standards in 10 CR 2.810. the Office of Management and Budget. 101–576, 104 Stat. 2842, as amended (31 U.S.C. 901, 902). The Regulatory Flexibility Analysis, List of Subjects prepared in accordance with 5 U.S.C. ■ 2. Section 170.20 is revised to read as 604, is included as Appendix A to this 10 CFR Part 170 follows: final rule. The Small Business Regulatory Byproduct material, Import and § 170.20 Average cost per professional Enforcement Fairness Act of 1996 export licenses, Intergovernmental staff-hour. (SBREFA) was signed into law on March relations, Non-payment penalties, Fees for permits, licenses, 29, 1996. The SBREFA requires all Nuclear materials, Nuclear power plants amendments, renewals, special projects, Federal agencies to prepare a written and reactors, Source material, Special part 55 re-qualification and replacement compliance guide for each rule for nuclear material. examinations and tests, other required reviews, approvals, and inspections which the agency is required by 5 U.S.C. 10 CFR Part 171 604 to prepare a regulatory flexibility under §§ 170.21 and 170.31 will be analysis. Therefore, in compliance with Annual charges, Byproduct material, calculated using the following the law, Attachment 1 to the Regulatory Holders of certificates, Registrations, applicable professional staff-hour rates: Flexibility Analysis is the small entity Approvals, Intergovernmental relations, (a) Reactor Program (§ 170.21 compliance guide for FY 2003. Non-payment penalties, Nuclear Activities): $156 per hour IX. Backfit Analysis materials, Nuclear power plants and (b) Nuclear Materials and Nuclear Waste reactors, Source material, Special Program (§ 170.31 Activities): $158 The NRC has determined that the nuclear material. per hour backfit rule, 10 CFR 50.109, does not ■ apply to this final rule and that a backfit ■ For the reasons set out in the preamble 3. In § 170.21, Category K in the table analysis is not required for this final and under the authority of the Atomic is revised to read as follows: rule. The backfit analysis is not required Energy Act of 1954, as amended; the § 170.21 Schedule of fees for production because these amendments do not Energy Reorganization Act of 1974, as and utilization facilities, review of standard require the modification of or additions amended; and 5 U.S.C. 552 and 553, the referenced design approvals, special to systems, structures, components, or NRC is adopting the following projects, inspections and import and export the design of a facility or the design amendments to 10 CFR Parts 170 and licenses. approval or manufacturing license for a 171. * * * * *

SCHEDULE OF FACILITY FEES [See footnotes at end of table]

Facility categories and type of fees Fees 1,2

******* K. Import and export licenses: Licenses for the import and export only of production and utilization facilities or the export only of components for production and utilization facilities issued under 10 CFR Part 110: 1. Application for import or export of reactors and other facilities and exports of components which must be reviewed by the Commissioners and the Executive Branch, for example, actions under 10 CFR 110.40(b). This category includes application for import of radioactive waste. Application-new license ...... $10,300 Amendment ...... $10,300 2. Application for export of reactor and other components requiring Executive Branch review only, for example, those actions under 10 CFR 110.41(a)(1)–(8). This category includes application for the export of radioactive waste. Application-new license ...... $6,000 Amendment ...... $6,000 3. Application for export of components requiring foreign government assurances only. Application-new license ...... $1,900 Amendment ...... $1,900 4. Application for export of facility components and equipment not requiring Commissioner review, Executive Branch review, or foreign government assurances. Application-new license ...... $1,300 Amendment ...... $1,300

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SCHEDULE OF FACILITY FEES—Continued [See footnotes at end of table]

Facility categories and type of fees Fees 1,2

5. Minor amendment of any export or import license to extend the expiration date, change domestic information, or make other revisions which do not require in-depth analysis or review. Amendment ...... $240 1 Fees will not be charged for orders issued by the Commission under § 2.202 of this chapter or for amendments resulting specifically from the requirements of these types of Commission orders. Fees will be charged for approvals issued under a specific exemption provision of the Com- mission’s regulations under Title 10 of the Code of Federal Regulations (e.g., 10 CFR 50.12, 73.5) and any other sections in effect now or in the future, regardless of whether the approval is in the form of a license amendment, letter of approval, safety evaluation report, or other form. Fees for licenses in this schedule that are initially issued for less than full power are based on review through the issuance of a full power license (generally full power is considered 100 percent of the facility’s full rated power). Thus, if a licensee received a low power license or a temporary license for less than full power and subsequently receives full power authority (by way of license amendment or otherwise), the total costs for the license will be determined through that period when authority is granted for full power operation. If a situation arises in which the Commission determines that full operating power for a particular facility should be less than 100 percent of full rated power, the total costs for the license will be at that determined lower operating power level and not at the 100 percent capacity. 2 Full cost fees will be determined based on the professional staff time and appropriate contractual support services expended. For applications currently on file and for which fees are determined based on the full cost expended for the review, the professional staff hours expended for the review of the application up to the effective date of the final rule will be determined at the professional rates in effect at the time the service was provided. For those applications currently on file for which review costs have reached an applicable fee ceiling established by the June 20, 1984, and July 2, 1990, rules, but are still pending completion of the review, the cost incurred after any applicable ceiling was reached through January 29, 1989, will not be billed to the applicant. Any professional staff-hours expended above those ceilings on or after January 30, 1989, will be assessed at the applicable rates established by § 170.20, as appropriate, except for topical reports whose costs exceed $50,000. Costs which exceed $50,000 for any topical report, amendment, revision or supplement to a topical report completed or under review from January 30, 1989, through August 8, 1991, will not be billed to the applicant. Any professional hours expended on or after August 9, 1991, will be assessed at the applicable rate established in § 170.20.

* * * * * § 170.31 Schedule of fees for materials materials licenses or import and export licenses and other regulatory services, ■ 4. Section 170.31 is revised to read as licenses shall pay fees for the following including inspections, and import and categories of services. The following follows: export licenses. schedule includes fees for health and Applicants for materials licenses, safety and safeguards inspections where import and export licenses, and other applicable: regulatory services, and holders of

SCHEDULE OF MATERIALS FEES [See footnotes at end of table]

Category of materials licenses and type of fees1 Fee 2,3

1. Special nuclear material: A. Licenses for possession and use of 200 grams or more of plutonium in unsealed form or 350 grams or more of contained U–235 in unsealed form or 200 grams or more of U–233 in unsealed form. This includes applications to terminate licenses as well as licenses authorizing possession only: Licensing and Inspection ...... Full Cost. B. Licenses for receipt and storage of spent fuel and reactor-related Greater than Class C (GTCC) waste at an independent spent fuel storage installation (ISFSI): Licensing and inspection ...... Full Cost. C. Licenses for possession and use of special nuclear material in sealed sources contained in devices used in industrial measuring systems, including x-ray fluorescence analyzers:4 Application ...... $730. D. All other special nuclear material licenses, except licenses authorizing special nuclear material in unsealed form in combination that would constitute a critical quantity, as defined in § 150.11 of this chapter, for which the licensee shall pay the same fees as those for Category 1A:4 Application ...... $1,500. E. Licenses or certificates for construction and operation of a uranium enrichment facility: Licensing and inspection ...... Full Cost. 2. Source material: A. (1) Licenses for possession and use of source material in recovery operations such as milling, in-situ leaching, heap- leaching, refining uranium mill concentrates to uranium hexafluoride, ore buying stations, and ion exchange facilities, and in processing of ores containing source material for extraction of metals other than uranium or thorium, including licenses authorizing the possession of byproduct waste material (tailings) from source material recovery operations, as well as licenses authorizing the possession and maintenance of a facility in a standby mode: Licensing and inspection ...... Full Cost. (2) Licenses that authorize the receipt of byproduct material, as defined in Section 11e(2) of the Atomic Energy Act, from other persons for possession and disposal except those licenses subject to fees in Category 2A(1): Licensing and inspection ...... Full Cost (3) Licenses that authorize the receipt of byproduct material, as defined in Section 11e.(2) of the Atomic Energy Act, from other persons for possession and disposal incidental to the disposal of the uranium waste tailings generated by the licensee’s milling operations, except those licenses subject to the fees in Category 2A(1): Licensing and inspection ...... Full Cost. B. Licenses which authorize the possession, use, and/or installation of source material for shielding: Application ...... $170.

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SCHEDULE OF MATERIALS FEES—Continued [See footnotes at end of table]

Category of materials licenses and type of fees1 Fee 2,3

C. All other source material licenses: Application ...... $6,200 3. Byproduct material: A. Licenses of broad scope for the possession and use of byproduct material issued under parts 30 and 33 of this chapter for processing or manufacturing of items containing byproduct material for commercial distribution: Application ...... $7,400. B. Other licenses for possession and use of byproduct material issued under part 30 of this chapter for processing or manufacturing of items containing byproduct material for commercial distribution: Application ...... $2,900. C. Licenses issued under §§ 32.72, 32.73, and/or 32.74 of this chapter that authorize the processing or manufacturing and distribution or redistribution of radiopharmaceuticals, generators, reagent kits, and/or sources and devices containing byproduct material. This category does not apply to licenses issued to nonprofit educational institutions whose processing or manufacturing is exempt under § 170.11(a)(4). These licenses are covered by fee Category 3D. Application ...... $6,100. D. Licenses and approvals issued under §§ 32.72, 32.73, and/or 32.74 of this chapter authorizing distribution or redistribution of radiopharmaceuticals, generators, reagent kits, and/or sources or devices not involving processing of byproduct material. This category includes licenses issued under §§ 32.72, 32.73, and/or 32.74 of this chapter to nonprofit educational institutions whose processing or manufacturing is exempt under § 170.11(a)(4). Application ...... $2,700. E. Licenses for possession and use of byproduct material in sealed sources for irradiation of materials in which the source is not removed from its shield (self-shielded units): Application ...... $1,800. F. Licenses for possession and use of less than 10,000 curies of byproduct material in sealed sources for irradiation of materials in which the source is exposed for irradiation purposes. This category also includes underwater irradiators for irradiation of materials where the source is not exposed for irradiation purposes. Application ...... $3,700. G. Licenses for possession and use of 10,000 curies or more of byproduct material in sealed sources for irradiation of materials in which the source is exposed for irradiation purposes. This category also includes underwater irradiators for irradiation of materials where the source is not exposed for irradiation purposes. Application ...... $8,800. H. Licenses issued under Subpart A of part 32 of this chapter to distribute items containing byproduct material that require device review to persons exempt from the licensing requirements of part 30 of this chapter. The category does not include specific licenses authorizing redistribution of items that have been authorized for distribution to persons exempt from the licensing requirements of part 30 of this chapter: Application ...... $4,300. I. Licenses issued under Subpart A of part 32 of this chapter to distribute items containing byproduct material or quantities of byproduct material that do not require device evaluation to persons exempt from the licensing requirements of part 30 of this chapter. This category does not include specific licenses authorizing redistribution of items that have been authorized for distribution to persons exempt from the licensing requirements of part 30 of this chapter: Application ...... $4,300. J. Licenses issued under Subpart B of part 32 of this chapter to distribute items containing byproduct material that require sealed source and/or device review to persons generally licensed under part 31 of this chapter. This category does not include specific licenses authorizing redistribution of items that have been authorized for distribution to persons generally licensed under part 31 of this chapter: Application ...... $1,100. K. Licenses issued under Subpart B of part 32 of this chapter to distribute items containing byproduct material or quantities of byproduct material that do not require sealed source and/or device review to persons generally licensed under part 31 of this chapter. This category does not include specific licenses authorizing redistribution of items that have been authorized for distribution to persons generally licensed under part 31 of this chapter: Application ...... $650. L. Licenses of broad scope for possession and use of byproduct material issued under parts 30 and 33 of this chapter for research and development that do not authorize commercial distribution: Application ...... $6,200 M. Other licenses for possession and use of byproduct material issued under part 30 of this chapter for research and development that do not authorize commercial distribution: Application ...... $3,000. N. Licenses that authorize services for other licensees, except: (1) Licenses that authorize only calibration and/or leak testing services are subject to the fees specified in fee Category 3P; and (2) Licenses that authorize waste disposal services are subject to the fees specified in fee Categories 4A, 4B, and 4C: Application ...... $3,300. O. Licenses for possession and use of byproduct material issued under part 34 of this chapter for industrial radiography operations: Application ...... $3,300. P. All other specific byproduct material licenses, except those in Categories 4A through 9D: Registration ...... $1,200. Q. Registration of a device(s) generally licensed under part 31 of this chapter: Application ...... $620.

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SCHEDULE OF MATERIALS FEES—Continued [See footnotes at end of table]

Category of materials licenses and type of fees1 Fee 2,3

4. Waste disposal and processing: A. Licenses specifically authorizing the receipt of waste byproduct material, source material, or special nuclear material from other persons for the purpose of contingency storage or commercial land disposal by the licensee; or licenses authorizing contingency storage of low-level radioactive waste at the site of nuclear power reactors; or licenses for receipt of waste from other persons for incineration or other treatment, packaging of resulting waste and residues, and transfer of packages to another person authorized to receive or dispose of waste material: Licensing and inspection ...... Full Cost. B. Licenses specifically authorizing the receipt of waste byproduct material, source material, or special nuclear material from other persons for the purpose of packaging or repackaging the material. The licensee will dispose of the material by transfer to another person authorized to receive or dispose of the material: Application ...... $1,900. C. Licenses specifically authorizing the receipt of prepackaged waste byproduct material, source material, or special nuclear material from other persons. The licensee will dispose of the material by transfer to another person authorized to receive or dispose of the material: Application ...... $2,800. 5. Well logging: A. Licenses for possession and use of byproduct material, source material, and/or special nuclear material for well logging, well surveys, and tracer studies other than field flooding tracer studies: Application ...... $2,000. B. Licenses for possession and use of byproduct material for field flooding tracer studies: Licensing ...... Full Cost. 6. Nuclear laundries: A. Licenses for commercial collection and laundry of items contaminated with byproduct material, source material, or special nuclear material: Application ...... $12,600. 7. Medical licenses: A. Licenses issued under parts 30, 35, 40, and 70 of this chapter for human use of byproduct material, source material, or special nuclear material in sealed sources contained in teletherapy devices: Application ...... $6,900. B. Licenses of broad scope issued to medical institutions or two or more physicians under parts 30, 33, 35, 40, and 70 of this chapter authorizing research and development, including human use of byproduct material, except licenses for byproduct material, source material, or special nuclear material in sealed sources contained in teletherapy devices: Application ...... $4,900. C. Other licenses issued under parts 30, 35, 40, and 70 of this chapter for human use of byproduct material, source material, and/or special nuclear material, except licenses for byproduct material, source material, or special nuclear material in sealed sources contained in teletherapy devices: Application ...... $1,900. 8. Civil defense: A. Licenses for possession and use of byproduct material, source material, or special nuclear material for civil defense activities: Application ...... $360. 9. Device, product, or sealed source safety evaluation: A. Safety evaluation of devices or products containing byproduct material, source material, or special nuclear material, except reactor fuel devices, for commercial distribution: Application—each device ...... $5,700. B. Safety evaluation of devices or products containing byproduct material, source material, or special nuclear material manufactured in accordance with the unique specifications of, and for use by, a single applicant, except reactor fuel devices: Application—each device ...... $5,700. C. Safety evaluation of sealed sources containing byproduct material, source material, or special nuclear material, except reactor fuel, for commercial distribution: Application—each source ...... $1,800. D. Safety evaluation of sealed sources containing byproduct material, source material, or special nuclear material, manufactured in accordance with the unique specifications of, and for use by, a single applicant, except reactor fuel: Application—each source ...... $600. 10. Transportation of radioactive material: A. Evaluation of casks, packages, and shipping containers: Licensing and inspections ...... Full Cost. B. Evaluation of 10 CFR Part 71 quality assurance programs: Application ...... $2,100. Inspections ...... Full Cost. 11. Review of standardized spent fuel facilities: Licensing and inspection ...... Full Cost. 12. Special projects: Approvals and preapplication/Licensing activities ...... Full Cost. Inspections ...... Full Cost. 13. A. Spent fuel storage cask Certificate of Compliance: Licensing ...... Full Cost. B. Inspections related to spent fuel storage cask Certificate of Compliance ...... Full Cost. C. Inspections related to storage of spent fuel under § 72.210 of this chapter ...... Full Cost.

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SCHEDULE OF MATERIALS FEES—Continued [See footnotes at end of table]

Category of materials licenses and type of fees1 Fee 2,3

14. Byproduct, source, or special nuclear material licenses and other approvals authorizing decommissioning, decontamination, reclamation, or site restoration activities under parts 30, 40, 70, 72, and 76 of this chapter: Licensing and inspection ...... Full Cost. 15. Import and Export licenses: Licenses issued under part 110 of this chapter for the import and export only of special nuclear material, source material, tritium and other byproduct material, heavy water, or nuclear grade graphite. A. Application for export or import of high enriched uranium and other materials, including radioactive waste, which must be reviewed by the Commissioners and the Executive Branch, for example, those actions under 10 CFR 110.40(b). This category includes application for import of radioactive waste. Application—new license ...... $10,300. Amendment ...... $10,300. B. Application for export or import of special nuclear material, source material, tritium and other byproduct material, heavy water, or nuclear grade graphite, including radioactive waste, requiring Executive Branch review but not Com- missioner review. This category includes application for the export of radioactive waste. Application—new license ...... $6,000. Amendment ...... $6,000. C. Application for export of routine reloads of low enriched uranium reactor fuel and exports of source material requiring only foreign government assurances under the Atomic Energy Act. Application—new license ...... $1,900. Amendment ...... $1,900. D. Application for export or import of other materials, including radioactive waste, not requiring Commissioner review, Executive Branch review, or foreign government assurances under the Atomic Energy Act. This category includes application for export or import of radioactive waste where the NRC has previously authorized the export or import of the same form of waste to or from the same or similar parties, requiring only confirmation from the receiving facility and licensing authorities that the shipments may proceed according to previously agreed understandings and procedures. Application—new license ...... $1,300. Amendment ...... $1,300. E. Minor amendment of any export or import license to extend the expiration date, change domestic information, or make other revisions which do not require in-depth analysis, review, or consultations with other agencies or foreign governments. Amendment ...... $240. 16. Reciprocity: Agreement State licensees who conduct activities under the reciprocity provisions of 10 CFR 150.20. Application ...... $1,500. 1 Types of fees—Separate charges, as shown in the schedule, will be assessed for pre-application consultations and reviews and applications for new licenses and approvals, issuance of new licenses and approvals, certain amendments and renewals to existing licenses and approvals, safety evaluations of sealed sources and devices, generally licensed device registrations, and certain inspections. The following guidelines apply to these charges: (a) Application and registration fees. Applications for new materials licenses and export and import licenses; applications to reinstate expired, terminated, or inactive licenses except those subject to fees assessed at full costs; applications filed by Agreement State licensees to register under the general license provisions of 10 CFR 150.20; and applications for amendments to materials licenses that would place the license in a higher fee category or add a new fee category must be accompanied by the prescribed application fee for each category. (1) Applications for licenses covering more than one fee category of special nuclear material or source material must be accompanied by the prescribed application fee for the highest fee category. (2) Applications for new licenses that cover both byproduct material and special nuclear material in sealed sources for use in gauging devices will pay the appropriate application fee for fee Category 1C only. (b) Licensing fees. Fees for reviews of applications for new licenses and for renewals and amendments to existing licenses, for pre-application consultations and for reviews of other documents submitted to NRC for review, and for project manager time for fee categories subject to full cost fees (fee Categories 1A, 1B, 1E, 2A, 4A, 5B, 10A, 11, 12, 13A, and 14) are due upon notification by the Commission in accordance with § 170.12(b). (c) Amendment fees. Applications for amendments to export and import licenses must be accompanied by the prescribed amendment fee for each license affected. An application for an amendment to a license or approval classified in more than one fee category must be accompanied by the prescribed amendment fee for the category affected by the amendment unless the amendment is applicable to two or more fee categories, in which case the amendment fee for the highest fee category would apply. (d) Inspection fees. Inspections resulting from investigations conducted by the Office of Investigations and non-routine inspections that result from third-party allegations are not subject to fees. Inspection fees are due upon notification by the Commission in accordance with § 170.12(c). (e) Generally licensed device registrations under 10 CFR 31.5. Submittals of registration information must be accompanied by the prescribed fee. 2 Fees will not be charged for orders issued by the Commission under 10 CFR 2.202 or for amendments resulting specifically from the requirements of these types of Commission orders. However, fees will be charged for approvals issued under a specific exemption provision of the Commission’s regulations under Title 10 of the Code of Federal Regulations (e.g., 10 CFR 30.11, 40.14, 70.14, 73.5, and any other sections in effect now or in the future), regardless of whether the approval is in the form of a license amendment, letter of approval, safety evaluation report, or other form. In addition to the fee shown, an applicant may be assessed an additional fee for sealed source and device evaluations as shown in Categories 9A through 9D. 3 Full cost fees will be determined based on the professional staff time multiplied by the appropriate professional hourly rate established in § 170.20 in effect at the time the service is provided, and the appropriate contractual support services expended. For applications currently on file for which review costs have reached an applicable fee ceiling established by the June 20, 1984, and July 2, 1990, rules, but are still pending completion of the review, the cost incurred after any applicable ceiling was reached through January 29, 1989, will not be billed to the applicant. Any professional staff-hours expended above those ceilings on or after January 30, 1989, will be assessed at the applicable rates established by § 170.20, as appropriate, except for topical reports whose costs exceed $50,000. Costs which exceed $50,000 for each topical report, amendment, revision, or supplement to a topical report completed or under review from January 30, 1989, through August 8, 1991, will not be billed to the applicant. Any professional hours expended on or after August 9, 1991, will be assessed at the applicable rate established in § 170.20. 4 Licensees paying fees under Categories 1A, 1B, and 1E are not subject to fees under Categories 1C and 1D for sealed sources authorized in the same license except for an application that deals only with the sealed sources authorized by the license.

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PART 171—ANNUAL FEES FOR reactors does not include generic decommissioning class. The FY 2003 REACTOR LICENSES AND FUEL activities specifically related to reactor operating power reactor surcharge to be CYCLE LICENSES AND MATERIAL decommissioning. assessed to each operating power reactor LICENSES, INCLUDING HOLDERS OF (c)(1) The FY 2003 annual fee for each is approximately $183,300. This amount CERTIFICATES OF COMPLIANCE, power reactor holding a part 50 license is calculated by dividing the total REGISTRATIONS, AND QUALITY that is in a decommissioning or operating power reactor surcharge ASSURANCE PROGRAM APPROVALS possession only status and has spent ($19.1 million) by the number of AND GOVERNMENT AGENCIES fuel on-site and each independent spent operating power reactors (104). LICENSED BY THE NRC fuel storage part 72 licensee who does (3) The FY 2003 surcharge allocated ■ not hold a part 50 license is $319,000. to the spent fuel storage/reactor 5. The authority citation for part 171 (2) The FY 2003 annual fee is continues to read as follows: decommissioning class of licenses is comprised of a base spent fuel storage/ $1.8 million. The FY 2003 spent fuel Authority: Sec. 7601, Pub. L. 99–272, 100 reactor decommissioning annual fee Stat. 146, as amended by sec. 5601, Pub. L. storage/reactor decommissioning (which is also included in the operating surcharge to be assessed to each 100–203, 101 Stat. 1330, as amended by sec. power reactor annual fee shown in 3201, Pub. L. 101–239, 103 Stat. 2132, as operating power reactor, each power amended by sec. 6101, Pub. L. 101–508, 104 paragraph (b) of this section), and an reactor in decommissioning or Stat. 1388, as amended by sec. 2903a, Pub. additional charge (surcharge). The possession only status that has spent L. 102–486, 106 Stat. 3125 (42 U.S.C. 2213, activities comprising the FY 2003 fuel onsite, and to each independent 2214); sec. 301, Pub. L. 92–314, 86 Stat. 227 surcharge are shown in paragraph (d)(1) spent fuel storage part 72 licensee who (42 U.S.C. 2201w); sec. 201, Pub. L. 93–438, of this section. The activities comprising does not hold a part 50 license is 88 Stat. 1242, as amended (42 U.S.C. 5841). the FY 2003 spent fuel storage/reactor approximately $14,900. This amount is ■ 6. In § 171.15 paragraphs (b), (c), (d), decommissioning rebaselined annual and (e) are revised to read as follows: calculated by dividing the total fee are: surcharge costs allocated to this class by § 171.15 Annual Fees: Reactor licenses (i) Generic and other research the total number of power reactor and independent spent fuel storage activities directly related to reactor licenses, except those that permanently licenses. decommissioning and spent fuel ceased operations and have no fuel on * * * * * storage; and site, and part 72 licensees who do not (b)(1) The FY 2003 annual fee for each (ii) Other safety, environmental, and hold a part 50 license. operating power reactor which must be safeguards activities related to reactor (e) The FY 2003 annual fees for collected by September 30, 2003, is decommissioning and spent fuel licensees authorized to operate a non- $3,251,000. storage, except costs for licensing and (2) The FY 2003 annual fee is inspection activities that are recovered power (test and research) reactor comprised of a base annual fee for under part 170 of this chapter. licensed under part 50 of this chapter, power reactors licensed to operate, a (d)(1) The activities comprising the unless the reactor is exempted from fees base spent fuel storage/reactor FY 2003 surcharge are as follows: under § 171.11(a), are as follows: decommissioning annual fee, and (i) Low level waste disposal generic Research reactor ...... $63,300 associated additional charges activities; Test reactor ...... $63,300 (ii) Activities not attributable to an (surcharges). The activities comprising ■ 7. In § 171.16, paragraphs (c), (d), and existing NRC licensee or class of the FY 2003 spent storage/reactor (e) are revised to read as follows: decommissioning base annual fee are licenses (e.g., international cooperative shown in paragraph (c)(2)(i) and (ii) of safety program and international § 171.16 Annual Fees: Materials this section. The activities comprising safeguards activities, support for the Licensees, Holders of Certificates of the FY 2003 surcharge are shown in Agreement State program, and site Compliance, Holders of Sealed Source and paragraph (d)(1) of this section. The decommissioning management plan Device Registrations, Holders of Quality Assurance Program Approvals and activities comprising the FY 2003 base (SDMP) activities); and (iii) Activities not currently subject to Government Agencies Licensed by the annual fee for operating power reactors NRC. are as follows: 10 CFR part 170 licensing and (i) Power reactor safety and safeguards inspection fees based on existing law or * * * * * regulation except licensing and Commission policy, e.g., reviews and (c) A licensee who is required to pay inspection activities recovered under inspections conducted of nonprofit an annual fee under this section may part 170 of this chapter and generic educational institutions, licensing qualify as a small entity. If a licensee reactor decommissioning activities. actions for Federal agencies, and costs qualifies as a small entity and provides (ii) Research activities directly related that would not be collected from small the Commission with the proper to the regulation of power reactors, entities based on Commission policy in certification along with its annual fee except those activities specifically accordance with the Regulatory payment, the licensee may pay reduced related to reactor decommissioning. Flexibility Act, 5 U.S.C. 601 et seq. annual fees as shown in the following (iii) Generic activities required largely (2) The total FY 2003 surcharge table. Failure to file a small entity for NRC to regulate power reactors, e.g., allocated to the operating power reactor certification in a timely manner could updating part 50 of this chapter, or class of licenses is $19.1 million, not result in the denial of any refund that operating the Incident Response Center. including the amount allocated to the might otherwise be due. The small The base annual fee for operating power spent fuel storage/reactor entity fees are as follows:

Miximum annual fee per licensed category

Small Businesses Not Engaged in Manufacturing and Small Not-For-Profit Organizations (Gross Annual Receipts): $350,000 to $5 million ...... $2,300

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Miximum annual fee per licensed category

Less than $350,000 ...... 500 Manufacturing entities that have an average of 500 employees or less: 35 to 500 employees ...... 2,300 Less than 35 employees ...... 500 Small Governmental Jurisdictions (Including publicly supported educational institutions) (Population): 20,000 to 50,000 ...... 2,300 Less than 20,000 ...... 500 Educational Institutions that are not State or Publicly Supported, and have 500 Employees or Less: 35 to 500 employees ...... $2,300 Less than 35 employees ...... $500

(1) A licensee qualifies as a small cannot access the NRC’s Web site, NRC each category applicable to the entity if it meets the size standards Form 526 may be obtained through the license(s). established by the NRC (See 10 CFR local point of contact listed in the NRC’s (d) The FY 2003 annual fees are 2.810). ‘‘Materials Annual Fee Billing comprised of a base annual fee and an (2) A licensee who seeks to establish Handbook,’’ NUREG/BR–0238, which is additional charge (surcharge). The status as a small entity for the purpose enclosed with each annual fee billing. activities comprising the FY 2003 of paying the annual fees required under The form can also be obtained by calling this section must file a certification the fee staff at 301–415–7554, or by e- surcharge are shown for convenience in statement with the NRC. The licensee mailing the fee staff at [email protected]. paragraph (e) of this section. The FY must file the required certification on (3) For purposes of this section, the 2003 annual fees for materials licensees NRC Form 526 for each license under licensee must submit a new certification and holders of certificates, registrations which it is billed. NRC Form 526 can be with its annual fee payment each year. or approvals subject to fees under this accessed through the NRC’s Web site at (4) The maximum annual fee a small section are shown in the following table: http://www.nrc.gov. For licensees who entity is required to pay is $2,300 for

SCHEDULE OF MATERIALS ANNUAL FEES AND FEES FOR GOVERNMENT AGENCIES LICENSED BY NRC [See footnotes at end of table]

Category of materials licenses Annual fees1,2,3

1. Special nuclear material: A. (1) Licenses for possession and use of U–235 or plutonium for fuel fabrication activities. (a) Strategic Special Nuclear Material: BWX Technologies SNM–42 ...... $5,836,000 Nuclear Fuel Services SNM–124 ...... 5,836,000 (b) Low Enriched Uranium in Dispersible Form Used for Fabrication of Power Reactor Fuel: Global Nuclear Fuel SNM–1097 ...... 1,957,000 Framatome ANP Richland SNM–1227 ...... 1,957,000 Westinghouse Electric Company SNM–1107 ...... 1,957,000 (2) All other special nuclear materials licenses not included in Category 1.A.(1) which are licensed for fuel cycle activities. (a) Facilities with limited operations: Framatome ANP SNM–1168 ...... 769,000 (b) All Others: General Electric SNM–960...... 559,000 B. Licenses for receipt and storage of spent fuel and reactor-related Greater than Class C (GTCC) waste at an independent spent fuel storage installation (ISFSI) ...... 11N/A C. Licenses for possession and use of special nuclear material in sealed sources contained in devices used in industrial measuring systems, including x-ray fluorescence analyzers ...... 1,900 D. All other special nuclear material licenses, except licenses authorizing special nuclear material in unsealed form in combination that would constitute a critical quantity, as defined in § 150.11 of this chapter, for which the licensee shall pay the same fees as those for Category 1.A.(2) ...... 4,500 E. Licenses or certificates for the operation of a uranium enrichment facility ...... 3,634,000 2. Source material: A. (1) Licenses for possession and use of source material for refining uranium mill concentrates to uranium hexafluoride .... 839,000 (2) Licenses for possession and use of source material in recovery operations such as milling, in-situ leaching, heap-leaching, ore buying stations, ion exchange facilities and in processing of ores containing source material for extraction of metals other than uranium or thorium, including licenses authorizing the possession of byproduct waste material (tailings) from source material recovery operations, as well as licenses authorizing the possession and maintenance of a facility in a standby mode. Class I facilities 4 ...... 63,700 Class II facilities 4 ...... 53,300 Other facilities 4 ...... 93,600 (3) Licenses that authorize the receipt of byproduct material, as defined in Section 11e.(2) of the Atomic Energy Act, from other persons for possession and disposal, except those licenses subject to the fees in Category 2A(2) or Category 2A(4) ...... 39,300

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SCHEDULE OF MATERIALS ANNUAL FEES AND FEES FOR GOVERNMENT AGENCIES LICENSED BY NRC—Continued [See footnotes at end of table]

Category of materials licenses Annual fees1,2,3

(4) Licenses that authorize the receipt of byproduct material, as defined in Section 11e.(2) of the Atomic Energy Act, from other persons for possession and disposal incidental to the disposal of the uranium waste tailings generated by the licensee’s milling operations, except those licenses subject to the fees in Category 2A(2) ...... 6,200 B. Licenses that authorize only the possession, use and/or installation of source material for shielding ...... 730 C. All other source material licenses ...... 11,400 3. Byproduct material: A. Licenses of broad scope for possession and use of byproduct material issued under parts 30 and 33 of this chapter for processing or manufacturing of items containing byproduct material for commercial distribution ...... 21,800 B. Other licenses for possession and use of byproduct material issued under part 30 of this chapter for processing or manufacturing of items containing byproduct material for commercial distribution ...... 6,600 C. Licenses issued under §§ 32.72, 32.73, and/or 32.74 of this chapter authorizing the processing or manufacturing and distribution or redistribution of radiopharmaceuticals, generators, reagent kits and/or sources and devices containing byproduct material. This category also includes the possession and use of source material for shielding authorized under part 40 of this chapter when included on the same license. This category does not apply to licenses issued to nonprofit educational institutions whose processing or manufacturing is exempt under § 171.11(a)(1). These licenses are covered by fee Category 3D ...... 10,900 D. Licenses and approvals issued under §§ 32.72, 32.73, and/or 32.74 of this chapter authorizing distribution or redistribution of radiopharmaceuticals, generators, reagent kits and/or sources or devices not involving processing of byproduct material. This category includes licenses issued under §§ 32.72, 32.73 and 32.74 of this chapter to nonprofit educational institutions whose processing or manufacturing is exempt under § 171.11(a)(1). This category also includes the possession and use of source material for shielding authorized under part 40 of this chapter when included on the same license 4,700 E. Licenses for possession and use of byproduct material in sealed sources for irradiation of materials in which the source is not removed from its shield (self-shielded units) ...... 3,600 F. Licenses for possession and use of less than 10,000 curies of byproduct material in sealed sources for irradiation of materials in which the source is exposed for irradiation purposes. This category also includes underwater irradiators for irradiation of materials in which the source is not exposed for irradiation purposes ...... 6,600 G. Licenses for possession and use of 10,000 curies or more of byproduct material in sealed sources for irradiation of materials in which the source is exposed for irradiation purposes. This category also includes underwater irradiators for irradiation of materials in which the source is not exposed for irradiation purposes ...... 24,100 H. Licenses issued under Subpart A of part 32 of this chapter to distribute items containing byproduct material that require device review to persons exempt from the licensing requirements of part 30 of this chapter, except specific licenses authorizing redistribution of items that have been authorized for distribution to persons exempt from the licensing requirements of part 30 of this chapter ...... 6,000 I. Licenses issued under Subpart A of part 32 of this chapter to distribute items containing byproduct material or quantities of byproduct material that do not require device evaluation to persons exempt from the licensing requirements of part 30 of this chapter, except for specific licenses authorizing redistribution of items that have been authorized for distribution to persons exempt from the licensing requirements of part 30 of this chapter ...... 6,100 J. Licenses issued under Subpart B of part 32 of this chapter to distribute items containing byproduct material that require sealed source and/or device review to persons generally licensed under part 31 of this chapter, except specific licenses authorizing redistribution of items that have been authorized for distribution to persons generally licensed under part 31 of this chapter ...... 2,200 K. Licenses issued under Subpart B of part 31 of this chapter to distribute items containing byproduct material or quantities of byproduct material that do not require sealed source and/or device review to persons generally licensed under part 31 of this chapter, except specific licenses authorizing redistribution of items that have been authorized for distribution to persons generally licensed under part 31 of this chapter ...... 1,400 L. Licenses of broad scope for possession and use of byproduct material issued under parts 30 and 33 of this chapter for research and development that do not authorize commercial distribution ...... 11,800 M. Other licenses for possession and use of byproduct material issued under part 30 of this chapter for research and development that do not authorize commercial distribution ...... 5,600 N. Licenses that authorize services for other licensees, except: (1) Licenses that authorize only calibration and/or leak testing services are subject to the fees specified in fee Cat- egory 3P; and. (2) Licenses that authorize waste disposal services are subject to the fees specified in fee Categories 4A, 4B, and 4C 6,100 O. Licenses for possession and use of byproduct material issued under part 34 of this chapter for industrial radiography operations. This category also includes the possession and use of source material for shielding authorized under part 40 of this chapter when authorized on the same license ...... 12,200 P. All other specific byproduct material licenses, except those in Categories 4A through 9D ...... 2,500 Q. Registration of devices generally licensed pursuant to part 31 of this chapter ...... 13 N/A 4. Waste disposal and processing: A. Licenses specifically authorizing the receipt of waste byproduct material, source material, or special nuclear material from other persons for the purpose of contingency storage or commercial land disposal by the licensee; or licenses authorizing contingency storage of low-level radioactive waste at the site of nuclear power reactors; or licenses for receipt of waste from other persons for incineration or other treatment, packaging of resulting waste and residues, and transfer of packages to another person authorized to receive or dispose of waste material ...... 5 N/A B. Licenses specifically authorizing the receipt of waste byproduct material, source material, or special nuclear material from other persons for the purpose of packaging or repackaging the material. The licensee will dispose of the material by transfer to another person authorized to receive or dispose of the material ...... 10,300

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SCHEDULE OF MATERIALS ANNUAL FEES AND FEES FOR GOVERNMENT AGENCIES LICENSED BY NRC—Continued [See footnotes at end of table]

Category of materials licenses Annual fees1,2,3

C. Licenses specifically authorizing the receipt of prepackaged waste byproduct material, source material, or special nuclear material from other persons. The licensee will dispose of the material by transfer to another person authorized to receive or dispose of the material ...... 7,400 5. Well logging: A. Licenses for possession and use of byproduct material, source material, and/or special nuclear material for well logging, well surveys, and tracer studies other than field flooding tracer studies ...... 4,700 B. Licenses for possession and use of byproduct material for field flooding tracer studies ...... 5 N/A 6. Nuclear laundries: A. Licenses for commercial collection and laundry of items contaminated with byproduct material, source material, or special nuclear material ...... 23,100 7. Medical licenses: A. Licenses issued under parts 30, 35, 40, and 70 of this chapter for human use of byproduct material, source material, or special nuclear material in sealed sources contained in teletherapy devices. This category also includes the possession and use of source material for shielding when authorized on the same license ...... 11,000 B. Licenses of broad scope issued to medical institutions or two or more physicians under parts 30, 33, 35, 40, and 70 of this chapter authorizing research and development, including human use of byproduct material except licenses for byproduct material, source material, or special nuclear material in sealed sources contained in teletherapy devices. This category also includes the possession and use of source material for shielding when authorized on the same license.9 ... 24,700 C. Other licenses issued under parts 30, 35, 40, and 70 of this chapter for human use of byproduct material, source material, and/or special nuclear material except licenses for byproduct material, source material, or special nuclear material in sealed sources contained in teletherapy devices. This category also includes the possession and use of source material for shielding when authorized on the same license.9 ...... 4,600 8. Civil defense: A. Licenses for possession and use of byproduct material, source material, or special nuclear material for civil defense activities ...... 1,300 9. Device, product, or sealed source safety evaluation: A. Registrations issued for the safety evaluation of devices or products containing byproduct material, source material, or special nuclear material, except reactor fuel devices, for commercial distribution ...... 7,000 B. Registrations issued for the safety evaluation of devices or products containing byproduct material, source material, or special nuclear material manufactured in accordance with the unique specifications of, and for use by, a single applicant, except reactor fuel devices ...... 7,000 C. Registrations issued for the safety evaluation of sealed sources containing byproduct material, source material, or special nuclear material, except reactor fuel, for commercial distribution ...... 2,200 D. Registrations issued for the safety evaluation of sealed sources containing byproduct material, source material, or special nuclear material, manufactured in accordance with the unique specifications of, and for use by, a single applicant, except reactor fuel ...... 730 10. Transportation of radioactive material: A. Certificates of Compliance or other package approvals issued for design of casks, packages, and shipping containers. Spent Fuel, High-Level Waste, and plutonium air packages ...... 6 N/A Other Casks ...... 6 N/A B. Quality assurance program approvals issued under part 71 of this chapter. Users and Fabricators ...... 76,200 Users ...... 7,100 11. Standardized spent fuel facilities ...... 6 N/A 12. Special Projects ...... 6 N/A 13. A. Spent fuel storage cask Certificate of Compliance ...... 6 N/A B. General licenses for storage of spent fuel under 10 CFR 72.210 ...... 12 N/A 14. Byproduct, source, or special nuclear material licenses and other approvals authorizing decommissioning, decontamination, reclamation, or site restoration activities under parts 30, 40, 70, 72, and 76 of this chapter ...... 7 N/A 15. Import and Export licenses ...... 8 N/A 16. Reciprocity ...... 8 N/A 17. Master materials licenses of broad scope issued to Government agencies ...... 228,000 18. Department of Energy: A. Certificates of Compliance ...... 10 1,386,000 B. Uranium Mill Tailing Radiation Control Act (UMTRCA) Activities ...... 950,000 1 Annual fees will be assessed based on whether a licensee held a valid license with the NRC authorizing possession and use of radioactive material during the current fiscal year. However, the annual fee is waived for those materials licenses and holders of certificates, registrations, and approvals who either filed for termination of their licenses or approvals or filed for possession only/storage licenses prior to October 1, 2002, and permanently ceased licensed activities entirely by September 30, 2002. Annual fees for licensees who filed for termination of a license, downgrade of a license, or for a possession only license during the fiscal year and for new licenses issued during the fiscal year will be prorated in accordance with the provisions of § 171.17. If a person holds more than one license, certificate, registration, or approval, the annual fee(s) will be assessed for each license, certificate, registration, or approval held by that person. For licenses that authorize more than one activity on a single license (e.g., human use and irradiator activities), annual fees will be assessed for each category applicable to the license. Licensees paying annual fees under Category 1A(1) are not subject to the annual fees for Category 1C and 1D for sealed sources authorized in the license. 2 Payment of the prescribed annual fee does not automatically renew the license, certificate, registration, or approval for which the fee is paid. Renewal applications must be filed in accordance with the requirements of parts 30, 40, 70, 71, 72, or 76 of this chapter. 3 Each fiscal year, fees for these materials licenses will be calculated and assessed in accordance with § 171.13 and will be published in the Federal Register for notice and comment. 4 A Class I license includes mill licenses issued for the extraction of uranium from uranium ore. A Class II license includes solution mining licenses(in-situ and heap leach) issued for the extraction of uranium from uranium ores including research and development licenses. An ‘‘other’’ license includes licenses for extraction of metals, heavy metals, and rare earths.

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5 There are no existing NRC licenses in these fee categories. If NRC issues a license for these categories, the Commission will consider establishing an annual fee for this type of license. 6 Standardized spent fuel facilities, 10 CFR Parts 71 and 72 Certificates of Compliance, and special reviews, such as topical reports, are not assessed an annual fee because the generic costs of regulating these activities are primarily attributable to users of the designs, certificates, and topical reports. 7 Licensees in this category are not assessed an annual fee because they are charged an annual fee in other categories while they are licensed to operate. 8 No annual fee is charged because it is not practical to administer due to the relatively short life or temporary nature of the license. 9 Separate annual fees will not be assessed for pacemaker licenses issued to medical institutions who also hold nuclear medicine licenses under Categories 7B or 7C. 10 This includes Certificates of Compliance issued to DOE that are not under the Nuclear Waste Fund. 11 See § 171.15(c). 12 See § 171.15(c). 13 No annual fee is charged for this category because the cost of the general license registration program applicable to licenses in this category will be recovered through 10 CFR part 170 fees.

(e) The activities comprising the uses the size standards to reduce the impact specific class of licenses, in which case the surcharge are as follows: of annual fees on small entities by annual fee base would be reestablished. (1) LLW disposal generic activities; establishing a licensee’s eligibility to qualify Based on the change in the magnitude of (2) Activities not directly attributable for a maximum small entity fee. The small the budget to be recovered through fees, the to an existing NRC licensee or class(es) entity fee categories in § 171.16(c) of this Commission has determined that it is appropriate to rebaseline its part 171 annual of licenses; e.g., international final rule are based on the NRC’s size standards. fees again in FY 2003. Rebaselining fees will cooperative safety program and From FY 1991 through FY 2000, the result in increased annual fees for a majority international safeguards activities; Omnibus Budget Reconciliation Act (OBRA– of the categories of licenses, decreased support for the Agreement State 90), as amended, required that the NRC annual fees for other categories (including program; Site Decommissioning recover approximately 100 percent of its many materials licensees), and no change for Management Plan (SDMP) activities; budget authority, less appropriations from one category. and the Nuclear Waste Fund, by assessing license The Small Business Regulatory (3) Activities not currently assessed and annual fees. The FY 2001 Energy and Enforcement Fairness Act of 1996 (SBREFA) licensing and inspection fees under 10 Water Development Appropriations Act is intended to reduce regulatory burdens imposed by Federal agencies on small CFR part 170 based on existing law or amended OBRA–90 to decrease the NRC’s fee recovery amount by 2 percent per year businesses, nonprofit organizations, and Commission policy (e.g., reviews and governmental jurisdictions. SBREFA also inspections of nonprofit educational beginning in FY 2001, until the fee recovery amount is 90 percent in FY 2005. The provides Congress with the opportunity to institutions and reviews for Federal amount to be recovered for FY 2003 is review agency rules before they go into effect. agencies; activities related to approximately $526.3 million. Under this legislation, the NRC annual fee rule is considered a ‘‘major’’ rule and must decommissioning and reclamation; and OBRA–90 requires that the schedule of be reviewed by Congress and the Comptroller costs that would not be collected from charges established by rule should fairly and General before the rule becomes effective. small entities based on Commission equitably allocate the total amount to be SBREFA also requires that an agency prepare recovered from the NRC’s licensees and be policy in accordance with the a guide to assist small entities in complying Regulatory Flexibility Act, 5 U.S.C. 601 assessed under the principle that licensees with each rule for which a final regulatory et seq.) who require the greatest expenditure of flexibility analysis is prepared. This agency resources pay the greatest annual Regulatory Flexibility Analysis (RFA) and the Dated at Rockville, Maryland, this 30th day charges. Since FY 1991, the NRC has of May, 2003. small entity compliance guide (Attachment complied with OBRA–90 by issuing a final 1) have been prepared for the FY 2003 fee For the Nuclear Regulatory Commission. rule that amends its fee regulations. These rule as required by law. Jesse L. Funches, final rules have established the methodology Chief Financial Officer. used by NRC in identifying and determining II. Impact on Small Entities the fees to be assessed and collected in any The fee rule results in substantial fees Note: This appendix will not appear in the given fiscal year. being charged to those individuals, Code of Federal Regulations. In FY 1995, the NRC announced that, in organizations, and companies that are order to stabilize fees, annual fees would be licensed by the NRC, including those Appendix A to This Final Rule—Final adjusted only by the percentage change (plus licensed under the NRC materials program. Regulatory Flexibility Analysis for the or minus) in NRC’s total budget authority, The comments received on previous Amendments to 10 CFR Part 170 adjusted for changes in estimated collections proposed fee rules and the small entity (License Fees) and 10 CFR Part 171 for 10 CFR Part 170 fees, the number of certifications received in response to (Annual Fees) licensees paying annual fees, and as previous final fee rules indicate that NRC otherwise needed to assure the billed licensees qualifying as small entities under I. Background amounts resulted in the required collections. the NRC’s size standards are primarily The Regulatory Flexibility Act (RFA), as The NRC indicated that if there were a materials licensees. Therefore, this analysis amended, (5 U.S.C. 601 et seq.) requires that substantial change in the total NRC budget will focus on the economic impact of the agencies consider the impact of their authority or the magnitude of the budget annual fees on materials licensees. About 24 rulemakings on small entities and, consistent allocated to a specific class of licenses, the percent of these licensees (approximately with applicable statutes, consider annual fee base would be recalculated. 1,200 licensees for FY 2002) have requested alternatives to minimize these impacts on the In FY 1999, the NRC concluded that there small entity certification in the past. A 1993 businesses, organizations, and government had been significant changes in the allocation NRC survey of its materials licensees jurisdictions to which they apply. of agency resources among the various indicated that about 25 percent of these The NRC has established standards for classes of licenses and established licensees could qualify as small entities determining which NRC licensees qualify as rebaselined annual fees for FY 1999. The under the NRC’s size standards. small entities (10 CFR 2.810). These size NRC stated in the final FY 1999 rule that to The commenters on previous fee standards were established on the basis of the stabilize fees it would continue to adjust the rulemakings consistently indicated that the Small Business Administration’s most annual fees by the percent change method following results would occur if the proposed common receipts-based size standards and established in FY 1995, unless there is a annual fees were not modified: include a size standard for business concerns substantial change in the total NRC budget or 1. Large firms would gain an unfair that are manufacturing entities. The NRC the magnitude of the budget allocated to a competitive advantage over small entities.

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Commenters noted that small and very small benchmark to assist it in determining the annual fee for many small entities was companies (‘‘Mom and Pop’’ operations) amount or the percent of gross receipts that reduced while at the same time materials would find it more difficult to absorb the should be charged to a small entity. In licensees, including small entities, would annual fee than a large corporation or a high- developing the maximum small entity annual pay for most of the costs attributable to them. volume type of operation. In competitive fee in FY 1991, the NRC examined its 10 CFR The costs not recovered from small entities markets, such as soils testing, annual fees Part 170 licensing and inspection fees and are allocated to other materials licensees and would put small licensees at an extreme Agreement State fees for those fee categories to power reactors. competitive disadvantage with their much which were expected to have a substantial While reducing the impact on many small larger competitors because the proposed fees number of small entities. Six Agreement entities, the NRC determined that the would be the same for a two-person licensee States, Washington, Texas, Illinois, Nebraska, maximum annual fee of $2,300 for small as for a large firm with thousands of New York, and Utah, were used as entities may continue to have a significant employees. benchmarks in the establishment of the impact on materials licensees with annual 2. Some firms would be forced to cancel maximum small entity annual fee in FY gross receipts in the thousands of dollars their licenses. A licensee with receipts of less 1991. Because small entities in those range. Therefore, the NRC continued to than $500,000 per year stated that the Agreement States were paying the fees, the provide a lower-tier small entity annual fee proposed rule would, in effect, force it to NRC concluded that these fees did not have for small entities with relatively low gross relinquish its soil density gauge and license, a significant impact on a substantial number annual receipts, and for manufacturing thereby reducing its ability to do its work of small entities. Therefore, those fees were concerns and educational institutions not effectively. Other licensees, especially well- considered a useful benchmark in State or publicly supported, with less than 35 loggers, noted that the increased fees would establishing the NRC maximum small entity employees. The NRC also increased the lower force small businesses to get rid of the annual fee. tier small entity fee by the same percentage materials license altogether. Commenters The NRC maximum small entity fee was increase to the maximum small entity annual stated that the proposed rule would result in established as an annual fee only. In addition fee. This 25 percent increase resulted in the about 10 percent of the well-logging licensees to the annual fee, NRC small entity licensees lower tier small entity fee increasing from terminating their licenses immediately and were required to pay amendment, renewal $400 to $500 in FY 2000. approximately 25 percent terminating their and inspection fees. In setting the small The NRC examined the small entity fees licenses before the next annual assessment. entity annual fee, NRC ensured that the total again in FY 2001 (66 FR 32452; June 14, 3. Some companies would go out of amount small entities paid annually would 2001), and determined that a change was not business. not exceed the maximum paid in the six warranted to the small entity fees established 4. Some companies would have budget benchmark Agreement States. in FY 2000. The NRC stated in the Regulatory problems. Many medical licensees noted Of the six benchmark states, the maximum Flexibility Analysis for the FY 2001 final fee that, along with reduced reimbursements, the Agreement State fee of $3,800 in Washington rule that it would re-examine the small entity proposed increase of the existing fees and the was used as the ceiling for the total fees. fees every two years, in the same years in introduction of additional fees would Thus the NRC’s small entity fee was which it conducts the biennial review of fees significantly affect their budgets. Others developed to ensure that the total fees paid as required by the CFO Act. noted that, in view of the cuts by Medicare by NRC small entities would not exceed Accordingly, the NRC has re-examined the and other third party carriers, the fees would $3,800. Given the NRC’s FY 1991 fee small entity fees for FY 2003, and does not produce a hardship and some facilities structure for inspections, amendments, and believe that a change to the small entity fees would experience a great deal of difficulty in renewals, a small entity annual fee is warranted this year. Unlike the annual fees meeting this additional burden. established at $1,800 allowed the total fee assessed to other licensees, the small entity Approximately 3,000 license, approval, (small entity annual fee plus yearly average fees are not designed to recover the agency and registration terminations have been for inspections, amendments and renewal costs associated with particular licensees. requested since the NRC first established fees) for all categories to fall under the $3,800 Instead, the reduced fees for small entities annual fees for materials licenses. Although ceiling. are designed to provide some fee relief for some of these terminations were requested In FY 1992, the NRC introduced a second, qualifying small entity licensees while at the because the license was no longer needed or lower tier to the small entity fee in response same time recovering from them some of the licenses or registrations could be combined, to concerns that the $1,800 fee, when added agency’s costs for activities that benefit them. indications are that other termination to the license and inspection fees, still The costs not recovered from small entities requests were due to the economic impact of imposed a significant impact on small for activities that benefit them must be the fees. entities with relatively low gross annual recovered from other licensees. Given the To alleviate the significant impact of the receipts. For purposes of the annual fee, each reduction in annual fees and the relative low annual fees on a substantial number of small small entity size standard was divided into inflation rates, the NRC has determined that entities, the NRC considered the following an upper and lower tier. Small entity the current small entity fees of $500 and alternatives in accordance with the RFA, in licensees in the upper tier continued to pay $2,300 continue to meet the objective of developing each of its fee rules since FY an annual fee of $1,800 while those in the providing relief to many small entities while 1991. lower tier paid an annual fee of $400. recovering from them some of the costs that 1. Base fees on some measure of the Based on the changes that had occurred benefit them. amount of radioactivity possessed by the since FY 1991, the NRC re-analyzed its Therefore, the NRC is retaining the $2,300 licensee (e.g., number of sources). maximum small entity annual fees in FY small entity annual fee and the $500 lower 2. Base fees on the frequency of use of the 2000, and determined that the small entity tier small entity annual fee for FY 2003. The licensed radioactive material (e.g., volume of fees should be increased by 25 percent to NRC plans to re-examine the small entity fees patients). reflect the increase in the average fees paid again in FY 2005. 3. Base fees on the NRC size standards for by other materials licensees since FY 1991 as IV. Summary small entities. well as changes in the fee structure for The NRC has reexamined its previous materials licensees. The structure of the fees The NRC has determined that the 10 CFR evaluations of these alternatives and that NRC charged to its materials licensees Part 171 annual fees significantly impact a continues to believe that establishment of a changed during the period between 1991 and substantial number of small entities. A maximum fee for small entities is the most 1999. Costs for materials license inspections, maximum fee for small entities strikes a appropriate and effective option for reducing renewals, and amendments, which were balance between the requirement to recover the impact of its fees on small entities. previously recovered through part 170 fees 94 percent of the NRC budget and the for services, are now included in the part 171 requirement to consider means of reducing III. Maximum Fee annual fees assessed to materials licensees. the impact of the fee on small entities. On the The RFA and its implementing guidance As a result, the maximum small entity annual basis of its regulatory flexibility analysis, the do not provide specific guidelines on what fee increased from $1,800 to $2,300 in FY NRC concludes that a maximum annual fee constitutes a significant economic impact on 2000. By increasing the maximum annual fee of $2,300 for small entities and a lower-tier a small entity; therefore, the NRC has no for small entities from $1,800 to $2,300, the small entity annual fee of $500 for small

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businesses and not-for-profit organizations Licensees who meet NRC’s size standards 4. Small governmental jurisdiction—a with gross annual receipts of less than for a small entity must submit a completed government of a city, county, town, $350,000, small governmental jurisdictions NRC Form 526 ‘‘Certification of Small Entity township, village, school district or special with a population of less than 20,000, small Status for the Purposes of Annual Fees district with a population of less than 50,000; manufacturing entities that have less than 35 Imposed Under 10 CFR Part 171’’ to qualify 5. Small educational institution—an employees, and educational institutions that for the reduced annual fee. This form can be educational institution supported by a are not State or publicly supported and have accessed on the NRC’s Web site at http:// qualifying small governmental jurisdiction, less than 35 employees reduces the impact www.nrc.gov. The form can then be accessed or one that is not state or publicly supported on small entities. At the same time, these by selecting ‘‘License Fees’’ and under and has 500 or fewer employees.1 reduced annual fees are consistent with the ‘‘Forms’’ selecting NRC Form 526. For To further assist licensees in determining objectives of OBRA–90. Thus, the fees for licensees who cannot access the NRC’s Web if they qualify as a small entity, we are small entities maintain a balance between the site, NRC Form 526 may be obtained through objectives of OBRA–90 and the RFA. the local point of contact listed in the NRC’s providing the following guidelines, which Therefore, the analysis and conclusions ‘‘Materials Annual Fee Billing Handbook,’’ are based on the Small Business previously established remain valid for FY NUREG/BR–0238, which is enclosed with Administration’s regulations (13 CFR Part 2003. each annual fee billing. Alternatively, the 121). 1. A small business concern is an Attachment 1 to Appendix A—U.S. Nuclear form may be obtained by calling the fee staff at 301–415–7554, or by e-mailing the fee staff independently owned and operated entity Regulatory Commission Small Entity which is not considered dominant in its field Compliance Guide; Fiscal Year 2003 at [email protected]. The completed form, the appropriate small entity fee, and the payment of operations. Contents copy of the invoice should be mailed to the 2. The number of employees means the Introduction U.S. Nuclear Regulatory Commission, total number of employees in the parent NRC Definition of Small Entity License Fee and Accounts Receivable company, any subsidiaries and/or affiliates, NRC Small Entity Fees Branch, to the address indicated on the including both foreign and domestic Instructions for Completing NRC Form 526 invoice. Failure to file the NRC small entity locations (i.e., not solely the number of certification Form 526 in a timely manner employees working for the licensee or Introduction may result in the denial of any refund that conducting NRC licensed activities for the The Small Business Regulatory might otherwise be due. company). Enforcement Fairness Act of 1996 (SBREFA) NRC Definition of Small Entity 3. Gross annual receipts includes all requires all Federal agencies to prepare a revenue received or accrued from any source, The NRC has defined a small entity for written guide for each ‘‘major’’ final rule as including receipts of the parent company, purposes of compliance with its regulations defined by the Act. The NRC’s fee rule, any subsidiaries and/or affiliates, and (10 CFR 2.810) as follows: published annually to comply with the account for both foreign and domestic Omnibus Budget Reconciliation Act of 1990 1. Small business—a for-profit concern that locations. Receipts include all revenues from (OBRA–90), as amended, is considered a provides a service or a concern not engaged sales of products and services, interest, rent, ‘‘major’’ rule under SBREFA. Therefore, in in manufacturing with average gross receipts compliance with the law, this guide has been of $5 million or less over its last 3 completed fees, and commissions, from whatever prepared to assist NRC material licensees in fiscal years; sources derived (i.e., not solely receipts from complying with the FY 2003 fee rule. 2. Manufacturing industry—a NRC licensed activities). Licensees may use this guide to determine manufacturing concern with an average 4. A licensee who is a subsidiary of a large whether they qualify as a small entity under number of 500 or fewer employees based entity does not qualify as a small entity. upon employment during each pay period for NRC regulations and are eligible to pay NRC Small Entity Fees reduced FY 2003 annual fees assessed under the preceding 12 calendar months; 10 CFR Part 171. The NRC has established 3. Small organizations—a not-for-profit In 10 CFR 171.16 (c), the NRC has two tiers of separate annual fees for those organization which is independently owned established two tiers of small entity fees for materials licensees who qualify as small and operated and has annual gross receipts licensees that qualify under the NRC’s size entities under NRC’s size standards. of $5 million or less; standards. The fees are as follows:

Maximum annual fee per licensed category

Small Business Not Engaged in Manufacturing and Small Not-For-Profit Organizations (Gross Annual Receipts): $350,000 to $5 million ...... $2,300 Less than $350,000 ...... 500 Manufacturing entities that have an average of 500 employees or less: 35 to 500 employees ...... 2,300 Less than 35 employees ...... 500 Small Governmental Jurisdictions (Including publicly supported educational institutions) (Population): 20,000 to 50,000 ...... 2,300 Less than 20,000 ...... 500 Educational Institutions that are not State or Publicly Supported, and have 500 Employees or Less: 35 to 500 employees ...... 2,300 Less than 35 employees ...... 500

To pay a reduced annual fee, a licensee under ‘‘Forms’’ selecting NRC Form 526. and submit the completed form and the must use NRC Form 526. Licensees can Those licensees that qualify as a ‘‘small appropriate payment to the address provided access this form on the NRC’s Web site at entity’’ under the NRC size standards at 10 on the invoice. For licensees who cannot http://www.nrc.gov. The form can then be CFR Part 2.810 can complete the form in access the NRC’s Web site, NRC Form 526 accessed by selecting ‘‘License Fees’’ and accordance with the instructions provided, may be obtained through the local point of

1 An educational institution referred to in the size nationally recognized accrediting agency or provides an educational program for which it standards is an entity whose primary function is association, who is legally authorized to provide a awards academic degrees, and whose educational education, whose programs are accredited by a program of organized instruction or study, who programs are available to the public.

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contact listed in the NRC’s ‘‘Materials (3) Gross annual receipts means all revenue maximum annual fee shown on NRC Form Annual Fee Billing Handbook,’’ NUREG/BR– in whatever form received or accrued from 526 for the size standard under which the 0238, which is enclosed with each annual fee whatever sources —not solely receipts from licensee qualifies, resulting in a fee of either invoice. Alternatively, licensees may obtain licensed activities. There are limited $1150 or $250 for each fee category billed, the form by calling the fee staff at 301–415– exceptions as set forth at 13 CFR 121.104. instead of the full small entity annual fee of 7544, or by e-mailing us at [email protected]. These are: the term receipts excludes net $2,300 or $500. Instructions for Completing NRC Small capital gains or losses; taxes collected for and A new small entity form (NRC Form 526) Entity Form 526 remitted to a taxing authority if included in must be filed with the NRC each fiscal year gross or total income; proceeds from the to qualify for reduced fees in that year. 1. File a separate NRC Form 526 for each transactions between a concern and its annual fee invoice received. Because a licensee’s ‘‘size,’’ or the size domestic or foreign affiliates (if also excluded standards, may change from year to year, the 2. Complete all items on NRC Form 526 as from gross or total income on a consolidated invoice reflects the full fee and a new Form follows: return filed with the IRS); and amounts 526 must be completed and returned in order a. The license number and invoice number collected for another entity by a travel agent, for the fee to be reduced to the small entity must be entered exactly as they appear on the real estate agent, advertising agent, or annual fee invoice. conference management service provider. fee amount. Licensees will not be issued a b. The Standard Industrial Classification (4) The owner of the entity, or an official new invoice for the reduced amount. The (SIC) or North American Industry empowered to act on behalf of the entity, completed NRC Form 526, the payment of Classification System (NAICS) Code must be must sign and date the small entity the appropriate small entity fee, and the entered if known. ‘‘Payment Copy’’ of the invoice should be c. The licensee’s name and address must be certification. The NRC sends invoices to its licensees for mailed to the U.S. Nuclear Regulatory entered as they appear on the invoice. Name Commission, License Fee and Accounts and/or address changes for billing purposes the full annual fee, even though some entities Receivable Branch at the address indicated must be annotated on the invoice. Correcting qualify for reduced fees as a small entity. the name and/or address on NRC Form 526, Licensees who qualify as a small entity and on the invoice. or on the invoice does not constitute a file NRC Form 526, which certifies eligibility If you have questions regarding the NRC’s request to amend the license. Any request to for small entity fees, may pay the reduced annual fees, please call the license fee staff amend a license is to be submitted to the fee, which for a full year is either $2,300 or at 301–415–7554, e-mail the fee staff at respective licensing staffs in the NRC $500 depending on the size of the entity, for [email protected], or write to the U.S. Nuclear Regional or Headquarters Offices. each fee category shown on the invoice. Regulatory Commission, Washington, DC d. Check the appropriate size standard for Licensees granted a license during the first 20555, Attention: Office of the Chief which the licensee qualifies as a small entity. six months of the fiscal year, and licensees Financial Officer. Check only one box. Note the following: who file for termination or for a possession False certification of small entity status (1) A licensee who is a subsidiary of a large only license and permanently cease licensed could result in civil sanctions being imposed entity does not qualify as a small entity. activities during the first six months of the by the NRC under the Program Fraud Civil (2) The size standards apply to the fiscal year, pay only 50 percent of the annual Remedies Act, 31 U.S.C. 3801 et. seq. NRC’s fee for that year. Such an invoice states the licensee, including all parent companies and implementing regulations are found at 10 affiliates— not the individual authorized ‘‘Amount Billed Represents 50% Proration.’’ CFR part 13. users listed in the license or the particular This means the amount due from a small segment of the organization that uses entity is not the prorated amount shown on [FR Doc. 03–14960 Filed 6–17–03; 8:45 am] licensed material. the invoice, but rather one-half of the BILLING CODE 7590–01–P

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Reader Aids Federal Register Vol. 68, No. 117 Wednesday, June 18, 2003

CUSTOMER SERVICE AND INFORMATION CFR PARTS AFFECTED DURING JUNE

Federal Register/Code of Federal Regulations At the end of each month, the Office of the Federal Register General Information, indexes and other finding 202–741–6000 publishes separately a List of CFR Sections Affected (LSA), which aids lists parts and sections affected by documents published since Laws 741–6000 the revision date of each title. 1951...... 35321 Presidential Documents 2 CFR 3560...... 32872 Executive orders and proclamations 741–6000 Proposed Rules: 3565...... 34552 The United States Government Manual 741–6000 Subtitles A and B...... 33883 4284...... 35321 Other Services 3 CFR 8 CFR Electronic and on-line services (voice) 741–6020 Proclamations: 1...... 35273 741–6064 Privacy Act Compilation 7683...... 33339 103...... 35273 Public Laws Update Service (numbers, dates, etc.) 741–6043 7684...... 34775 212...... 35151 TTY for the deaf-and-hard-of-hearing 741–6086 7685...... 36445 239...... 35273 7686...... 36447 287...... 35273 Executive Orders: ELECTRONIC RESEARCH 13159 (See Notice of 9 CFR World Wide Web June 10, 2003)...... 35149 82...... 34779 Administrative Orders: Full text of the daily Federal Register, CFR and other publications 93...... 35529 Notices: is located at: http://www.access.gpo.gov/nara 113...... 35282 Notice of June 10, 430...... 34208 Federal Register information and research tools, including Public 2003 ...... 35149 Proposed Rules: Inspection List, indexes, and links to GPO Access are located at: Presidential 93...... 33028 http://www.archives.gov/federallregister/ Determinations: E-mail No. 2003-24 of May 10 CFR 29, 2003 ...... 35525 35...... 35534 FEDREGTOC-L (Federal Register Table of Contents LISTSERV) is No. 2003-25 of May 72...... 33611 an open e-mail service that provides subscribers with a digital 29, 2003 ...... 35526 form of the Federal Register Table of Contents. The digital form 73...... 33611 of the Federal Register Table of Contents includes HTML and 4 CFR 170...... 36714 171...... 36714 PDF links to the full text of each document. 81...... 33831 765...... 32955 To join or leave, go to http://listserv.access.gpo.gov and select 5 CFR Proposed Rules: Online mailing list archives, FEDREGTOC-L, Join or leave the list 50...... 35585 (or change settings); then follow the instructions. 230...... 35265 301...... 35265 12 CFR PENS (Public Law Electronic Notification Service) is an e-mail 316...... 35265 service that notifies subscribers of recently enacted laws. 333...... 35265 37...... 35283 To subscribe, go to http://listserv.gsa.gov/archives/publaws-l.html 337...... 35265 615...... 33347, 33617 and select Join or leave the list (or change settings); then follow 410...... 35265 703...... 32958 the instructions. 831...... 35270 742...... 32958 1700...... 32627 FEDREGTOC-L and PENS are mailing lists only. We cannot 842...... 35270 Proposed Rules: respond to specific inquiries. 1600...... 35492 1601...... 35492 Ch. I ...... 35589 Reference questions. Send questions and comments about the 1603...... 35492 Ch. II ...... 35589 Federal Register system to: [email protected] 1604...... 35492 Ch. III ...... 35589 The Federal Register staff cannot interpret specific documents or 1605...... 35492 Ch. V...... 35589 regulations. 1606...... 35492 1640...... 35492 13 CFR 121...... 33348, 35285 FEDERAL REGISTER PAGES AND DATE, JUNE 1645...... 35492 1650...... 35492 Proposed Rules: 32623–32954...... 2 1651...... 35492 121...... 33412, 35334 1653...... 35492 32955–33338...... 3 14 CFR 33339–33610...... 4 1655...... 35492 1690...... 35492 33611–33830...... 5 25 ...... 33834, 33836, 35285, 36449 33831–34260...... 6 7 CFR 39 ...... 32629, 32967, 32968, 34261–34516...... 9 2...... 35256 33355, 33356, 33358, 33618, 34517–34774...... 10 319...... 34517 33621, 33840, 33842, 33844, 34775–35148...... 11 457...... 34261 33854, 34781, 34786, 34787, 35149–35264...... 12 723...... 34777 35152, 35155, 35157, 35160, 35265–35524...... 13 800...... 32623, 35490 35163, 35286, 36451, 36452, 35525–35782...... 16 802...... 34519 36454, 36455 35783–36444...... 17 1400...... 33341 71 ...... 32633, 33231, 33360, 36445–36742...... 18 1464...... 34777 33361, 33579, 33623, 35287, Proposed Rules: 35288, 35534, 35535, 35947 810...... 33408 91...... 35524 1220...... 35825, 36498 95...... 34522

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97 ...... 32633, 33536, 35538 520...... 34533, 34795 33...... 36408 439...... 34831 401...... 35289 522 ...... 33856, 34533, 34796 35...... 36408 712...... 34832 404...... 35289 524...... 33381 36...... 36408 725...... 35315 413...... 35289 558...... 34534 Proposed Rules: Proposed Rules: 1260...... 35290 601...... 34796 906...... 33032 Ch. I ...... 33898 Proposed Rules: 878...... 32983 934...... 33035 51...... 32802 25 ...... 33659, 35335, 45612 888...... 32635 938...... 33037 52 ...... 33041, 33042, 33043, 36...... 34256 1308...... 35293 33665, 33898, 33899, 34560, 39 ...... 32691, 32693, 32695, Proposed Rules: 31 CFR 36527 33030, 33416, 33418, 33420, 201...... 33429 1...... 32638 62...... 35191, 35348 33423, 33663, 33885, 34557, 310...... 36527 210...... 33826 82...... 33284 34843, 34847, 34849, 35186, 312...... 36527 594...... 34196 86...... 35830 35826, 36499, 36502, 36504, 314...... 36527 146...... 33902 36506, 36510, 36513, 36515, 320...... 36527 33 CFR 180...... 35349 36518, 36520, 36523, 36525 343...... 33429 100...... 32639, 32641 194...... 33429 71 ...... 33426, 33427, 34340 347...... 35346 117 ...... 32643, 34302, 34303, 261...... 36528 600...... 36527 34535, 34799, 34800, 34801, 15 CFR 601...... 36527 35296 42 CFR 734...... 35783 606...... 36527 165 ...... 32643, 32996, 32998, 412...... 34122, 34494 740...... 35783 33382, 33384, 33386, 33388, Proposed Rules: 742...... 34526, 35783 24 CFR 33390, 33392, 33393, 33395, 412...... 33579, 34492 744...... 34192 Proposed Rules: 33396, 33398, 33399, 33401, 413 ...... 33579, 34492, 34768 745...... 34526 1000...... 34344 33402, 34303, 34305, 34307, 748...... 35783 34535, 34537, 34803, 35172, 43 CFR 770...... 35783 25 CFR 36466 4...... 33794 772...... 34192 170...... 33625 203...... 36467 3800...... 32656 774...... 34526, 35783 309...... 35164 Proposed Rules: 4100...... 33794 Proposed Rules: 117...... 34877 5000...... 33794 930...... 34851 26 CFR 165 ...... 33894, 33896, 34370, 1 ...... 33381, 34293, 34797 35615 44 CFR 16 CFR 31...... 34797 64...... 32657 305...... 36458 301...... 33857 36 CFR 65...... 32659, 32660 Proposed Rules: 602...... 34293, 34797 215...... 33582 67...... 32664, 32669 1500...... 35191 Proposed Rules: 230...... 34309 206...... 34545 1700...... 35614 1 ...... 34344, 34874, 34875 242...... 33402 Proposed Rules: 14a...... 34344 251...... 35117 67...... 32699, 32717 17 CFR 25...... 34875 1253...... 33404 1...... 34790 31...... 34875 Proposed Rules: 46 CFR 30...... 33623 49...... 35828 1280...... 35829 10...... 35801 40...... 33623 53...... 34875 15...... 35801 201...... 35787 55...... 34875 37 CFR 221...... 33405 210...... 36636 156...... 34875 260...... 36469 228...... 36636 157...... 32698 47 CFR 229...... 36636 301...... 33887 38 CFR 2 ...... 32676, 33020, 33640, 240...... 36636 602...... 32698 1...... 35297 34336 249...... 36636 3...... 34539 21...... 34547 27 CFR 270...... 36636 13...... 34539 25...... 33640, 34336 274...... 36636 Proposed Rules: 21 ...... 34319, 34326, 35177 52...... 34547 7...... 32698 61...... 34332 73 ...... 32676, 33654, 35540, 18 CFR 25...... 32698 Proposed Rules: 35541, 35542 201...... 34795 20...... 33040 74...... 32676, 34336 28 CFR 76...... 35818 19 CFR 5...... 33629 39 CFR 78...... 34336 201...... 32081 571...... 34299, 34301 111...... 33858, 34805 80...... 32676 204...... 32081 802...... 32985 87...... 32676 206...... 32081 40 CFR 90...... 32676 29 CFR 207...... 32081 51...... 33764 95...... 32676 210...... 32081 1910...... 32637 52 ...... 32799, 33000, 33002, 97...... 32676, 33020 212...... 32081 1926...... 35172 33005, 33008, 33010, 33012, Proposed Rules: 4022...... 35294 33014, 33018, 33631, 33633, 1...... 34560 20 CFR 4044...... 35294 33635, 33638, 33873, 33875, 2...... 33043, 33666 Proposed Rules: Proposed Rules: 34543, 34808, 34813, 34821, 15...... 32720 220...... 34341 1910...... 33887, 34036 35790, 36470 21...... 34560 1915...... 34036 60...... 35792 25...... 33666 21 CFR 1926...... 34036 61...... 35792 64...... 32720 165...... 34272 62 ...... 34332, 35181, 35299, 73 ...... 33431, 33668, 33669, 201...... 32979 30 CFR 35792 35617 310...... 33362, 34273 6...... 36408 63...... 35792 74...... 34560 314...... 36676 7...... 36408 86...... 35792 76...... 35833 347...... 33362, 35290 18...... 36408 180 ...... 33876, 34825, 35303, 101...... 34560 349...... 32981 19...... 36408 36472, 36476, 36480 350...... 34273 20...... 36408 257...... 36487 48 CFR 352...... 33362 22...... 36408 258...... 36487 2...... 33231 369...... 34273 23...... 36408 261...... 32645 32...... 33231 510...... 33381, 34293 27...... 36408 271...... 34334, 34829 52...... 33231

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252...... 33026 171...... 32679 579...... 35132, 35145 635...... 35185, 35822 Proposed Rules: 173...... 32679 597...... 33655 648...... 33882 15...... 33330 177...... 32679 Proposed Rules: 660...... 32680 31...... 33326 180...... 32679 171...... 34880 679...... 34550 192...... 35574 52...... 33326 172...... 34880 Proposed Rules: 204...... 34879 195...... 35574 173...... 34880 16...... 33431 206...... 33057 375...... 35064 271...... 35354 377...... 35064 571...... 36534 17 ...... 33058, 33234, 34569 49 CFR 567...... 33655 402...... 33806 1 ...... 34548, 35183, 36496 571...... 33655, 34838 50 CFR 648...... 33432 26...... 35542 574...... 33655 17...... 34710, 35950 660 ...... 33670, 35354, 35575 107...... 32679 575...... 33655, 35184 100...... 33402

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REMINDERS comments due by 8-4-03; Patent statute; changes to New Hampshire; comments The items in this list were published 6-3-03 [FR 03- implement 2002 inter due by 6-27-03; published editorially compiled as an aid 13654] partes reexamination and 5-28-03 [FR 03-13175] to Federal Register users. other technical ENVIRONMENTAL Inclusion or exclusion from COMMENTS DUE NEXT amendments; comments PROTECTION AGENCY this list has no legal due by 6-27-03; published Superfund program: WEEK 4-28-03 [FR 03-10412] significance. National oil and hazardous COURT SERVICES AND AGRICULTURE substances contingency OFFENDER SUPERVISION plan— RULES GOING INTO DEPARTMENT AGENCY FOR THE National priorities list Agricultural Marketing DISTRICT OF COLUMBIA EFFECT JUNE 18, 2003 update; comments due Service Acceptance of gifts; comments by 6-23-03; published Grapes grown in— due by 6-23-03; published ENVIRONMENTAL 5-22-03 [FR 03-12612] PROTECTION AGENCY California; comments due by 4-22-03 [FR 03-09937] ENVIRONMENTAL Pesticides; tolerances in food, 6-23-03; published 4-22- Organization, functions, and 03 [FR 03-09843] authority delegations: PROTECTION AGENCY animal feeds, and raw Superfund program: agricultural commodities: AGRICULTURE Agency seal; comments due DEPARTMENT by 6-23-03; published 4- National oil and hazardous Azoxystrobin; published 6- substances contingency Agricultural Marketing 22-03 [FR 03-09936] 18-03; comments due by plan— 12-30-99; published 6-18- Service DEFENSE DEPARTMENT National priorities list 03 [FR 03-15261] Pistachio nuts, in shell and Federal Acquisition Regulation update; comments due shelled; grade standards; (FAR): Bacillus pumilus (strain by 6-23-03; published comments due by 6-23-03; Federal Prison Industries, QST2808); published 6- 5-22-03 [FR 03-12613] 18-03; comments due by published 5-23-03 [FR 03- Inc.; increased waiver 12-30-99; published 6-18- 12805] threshold; comments due ENVIRONMENTAL by 6-23-03; published 5- PROTECTION AGENCY 03 [FR 03-15129] AGRICULTURE 22-03 [FR 03-12305] Glyphosate; published 6-18- DEPARTMENT Superfund program: ENVIRONMENTAL 03; comments due by 12- Animal and Plant Health National oil and hazardous PROTECTION AGENCY 30-99; published 6-18-03 Inspection Service substances contingency Air programs; approval and plan— [FR 03-15128] Interstate transportation of Solid wastes: promulgation; State plans National priorities list animals and animal products for designated facilities and Residential lead-based paint update; comments due (quarantine): pollutants: waste disposal; solid by 6-23-03; published Tuberculosis in cattle and Vermont; comments due by waste disposal facilities 5-22-03 [FR 03-12614] bison— 6-23-03; published 5-22- and municipal solid waste ENVIRONMENTAL State and area 03 [FR 03-12863] landfills; classification and classifications; PROTECTION AGENCY practices criteria; ENVIRONMENTAL Superfund program: comments due by 6-24- PROTECTION AGENCY published 6-18-03; National oil and hazardous 03; published 4-25-03 Air programs; approval and comments due by 12-30- [FR 03-10242] substances contingency 99; published 6-18-03 [FR promulgation; State plans plan— AGRICULTURE for designated facilities and 03-15363] National priorities list DEPARTMENT pollutants: HEALTH AND HUMAN update; comments due Natural Resources Vermont; comments due by SERVICES DEPARTMENT by 6-23-03; published Conservation Service 6-23-03; published 5-22- Children and Families 5-22-03 [FR 03-12615] Support activities: 03 [FR 03-12864] Administration ENVIRONMENTAL Technical service provider ENVIRONMENTAL Personal Responsibility and PROTECTION AGENCY assistance; comments due PROTECTION AGENCY Work Opportunity by 6-23-03; published 3- Air programs; approval and Toxic substances: Reconciliation Act of 1996; 24-03 [FR 03-06668] promulgation; State plans Preliminary assessment implementation: information reporting— COMMERCE DEPARTMENT for designated facilities and Child support enforcement Benzenamine, 3-chloro- National Oceanic and pollutants: program; revision or 2,6-dinitro-N,N-dipropyl- Atmospheric Administration West Virginia; comments elimination of obsolete or due by 6-26-03; published 4-(trifluoromethyl), etc.; Fishery conservation and inconsistent provisions; 5-27-03 [FR 03-13176] comments due by 6-25- published 5-12-03; management: ENVIRONMENTAL 03; published 6-11-03 comments due by 12-30- Magnuson-Stevens Act [FR 03-14749] 99; published 5-12-03 [FR provisions— PROTECTION AGENCY Air programs; approval and FEDERAL 03-11223] Pacific Coast groundfish; promulgation; State plans COMMUNICATIONS fishing capacity TRANSPORTATION for designated facilities and COMMISSION reduction program; DEPARTMENT pollutants: Common carrier services: comments due by 6-27- Organization, functions, and West Virginia; comments 03; published 5-28-03 Telcommunications Act of authority delegations: due by 6-26-03; published [FR 03-13274] 1996; implementation— Maritime Administrator; 5-27-03 [FR 03-13177] Marine mammals: Pay telephone published 6-18-03; ENVIRONMENTAL reclassification and comments due by 12-30- Incidental taking— PROTECTION AGENCY compensation 99; published 6-18-03 [FR San Nicolas Island, CA; Air programs; State authority provisions; comments 03-15400] missile launch delegations: due by 6-23-03; TRANSPORTATION operations; pinnipeds; New Hampshire; comments published 6-2-03 [FR DEPARTMENT comments due by 6-23- due by 6-27-03; published 03-13722] Federal Aviation 03; published 5-9-03 5-28-03 [FR 03-13174] Radio stations; table of [FR 03-11613] Administration ENVIRONMENTAL assignments: Airworthiness directives: COMMERCE DEPARTMENT PROTECTION AGENCY California; comments due by Eurocopter France; Patent and Trademark Office Air programs; State authority 6-26-03; published 5-22- published 6-3-03; Patent cases: delegations: 03 [FR 03-12793]

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FEDERAL TRADE San Diego fairy shrimp; TRANSPORTATION 03; published 4-22-03 [FR COMMISSION comments due by 6-23- DEPARTMENT 03-09864] Alternative fuels and 03; published 4-22-03 Federal Aviation TRANSPORTATION alternative fueled vehicles; [FR 03-09434] Administration DEPARTMENT labeling requirements; NATIONAL AERONAUTICS Airspace: Federal Aviation comments due by 6-23-03; AND SPACE Construction or alteration in Administration published 5-8-03 [FR 03- ADMINISTRATION vicinity of private Airworthiness directives: 11391] Federal Acquisition Regulation residence of President of McDonnell Douglas; GENERAL SERVICES (FAR): United States; comments comments due by 6-24- ADMINISTRATION Federal Prison Industries, due by 6-23-03; published 03; published 4-25-03 [FR Federal Acquisition Regulation Inc.; increased waiver 4-22-03 [FR 03-09886] 03-09981] (FAR): threshold; comments due TRANSPORTATION TRANSPORTATION Federal Prison Industries, by 6-23-03; published 5- DEPARTMENT DEPARTMENT 22-03 [FR 03-12305] Inc.; increased waiver Federal Aviation Federal Aviation threshold; comments due NUCLEAR REGULATORY Administration Administration by 6-23-03; published 5- COMMISSION Airworthiness directives: 22-03 [FR 03-12305] Airworthiness directives: Nuclear equipment and Airbus; comments due by 6- Pratt & Whitney; comments HEALTH AND HUMAN material; export and import: 23-03; published 5-23-03 due by 6-23-03; published SERVICES DEPARTMENT Major nuclear reactor [FR 03-12836] 4-23-03 [FR 03-09984] Centers for Medicare & components; general TRANSPORTATION TRANSPORTATION Medicaid Services import license; comments DEPARTMENT DEPARTMENT Medicare: due by 6-27-03; published Federal Aviation Federal Aviation 5-28-03 [FR 03-13217] Billing privileges; Administration Administration establishment and NUCLEAR REGULATORY Airworthiness directives: Class E airspace; comments maintenance COMMISSION Boeing; comments due by due by 6-25-03; published requirements; comments Nuclear equipment and 6-23-03; published 4-23- 5-9-03 [FR 03-11645] due by 6-24-03; published material; export and import: 03 [FR 03-09691] 4-25-03 [FR 03-09943] TRANSPORTATION Major nuclear reactor TRANSPORTATION DEPARTMENT HEALTH AND HUMAN components; general DEPARTMENT SERVICES DEPARTMENT Federal Aviation import license; comments Federal Aviation Administration Food and Drug due by 6-27-03; published Administration Class E5 airspace; comments Administration 5-28-03 [FR 03-13216] Airworthiness directives: due by 6-23-03; published Food for human consumption: SMALL BUSINESS Boeing; comments due by 5-22-03 [FR 03-12818] Infant formula; current good ADMINISTRATION 6-24-03; published 4-25- TREASURY DEPARTMENT manufacturing practice, Small business size standards: 03 [FR 03-10115] quality control procedures, Comptroller of the Currency Nonmanufacturer rule; etc.; comments due by 6- TRANSPORTATION International banking activities: waivers— DEPARTMENT 27-03; published 4-28-03 Foreign banks seeking to [FR 03-10301] Other ordnance and Federal Aviation establish Federal accessories Administration HOMELAND SECURITY branches and agencies in manufacturing; Airworthiness directives: U.S.; approval procedures; DEPARTMENT comments due by 6-25- Coast Guard Bombardier; comments due comments due by 6-23- 03; published 6-13-03 by 6-23-03; published 5- 03; published 4-23-03 [FR Ports and waterways safety: [FR 03-14851] 23-03 [FR 03-12964] 03-09733] St. Croix, U.S. Virgin Small arms manufacturing; TRANSPORTATION TREASURY DEPARTMENT Islands; security zone; comments due by 6-25- DEPARTMENT comments due by 6-27- 03; published 6-13-03 Fiscal Service 03; published 4-28-03 [FR [FR 03-14850] Federal Aviation Checks drawn on U.S. Administration 03-10293] Size for Multiple Award Treasury; indorsement and payment; comments due by INTERIOR DEPARTMENT Schedule and other Airworthiness directives: 6-23-03; published 4-23-03 Fish and Wildlife Service multiple award contract Consolidated, Consolidated purposes and 8(a) Vultee, and Convair; [FR 03-09998] Endangered and threatened comments due by 6-23- TREASURY DEPARTMENT species: business development/ small disadvantaged 03; published 4-22-03 [FR Currency and foreign Critical habitat business status 03-09861] transactions; financial designations— determinations; comments TRANSPORTATION reporting and recordkeeping Cactus ferruginous due by 6-24-03; published DEPARTMENT requirements: pygmy-owl; Arizona 4-25-03 [FR 03-10286] Federal Aviation USA PATRIOT Act; distinct population TRANSPORTATION Administration implementation— segment; comments DEPARTMENT Banks lacking Federal due by 6-27-03; Airworthiness directives: functional regulator; published 4-28-03 [FR Federal Aviation de Havilland; comments due customer identification 03-10531] Administration by 6-23-03; published 4- Air traffic operating and flight 16-03 [FR 03-09304] programs; comments Coastal California due by 6-23-03; rules, etc.: Dornier; comments due by gnatcatcher; comments published 5-9-03 [FR 6-23-03; published 5-15- due by 6-23-03; Grand Canyon National 03-11015] published 4-24-03 [FR Park, AZ; special flight 03 [FR 03-12112] 03-09435] rules in vicinity— Dowty Aerospace Propellers; TREASURY DEPARTMENT Mussels in Mobile River Aircraft operations; noise comments due by 6-27- Alcohol and Tobacco Tax Basin, AL; comments limitations; comments 03; published 4-28-03 [FR and Trade Bureau due by 6-24-03; due by 6-23-03; 03-10334] Alcoholic beverages: published 3-26-03 [FR published 3-24-03 [FR Eurocopter France; Flavored malt beverages; 03-06903] 03-06918] comments due by 6-23- comments due by 6-23-

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03; published 3-24-03 [FR The text of laws is not S. 330/P.L. 108–29 03-06855] published in the Federal Labeling and advertising; Register but may be ordered Veterans’ Memorial Public Laws Electronic organic claims; comments in ‘‘slip law’’ (individual Preservation and Recognition Notification Service due by 6-23-03; published pamphlet) form from the Act of 2003 (May 29, 2003; (PENS) 5-9-03 [FR 03-11609] Superintendent of Documents, 117 Stat. 772) U.S. Government Printing PENS is a free electronic mail Office, Washington, DC 20402 S. 870/P.L. 108–30 LIST OF PUBLIC LAWS (phone, 202–512–1808). The notification service of newly text will also be made To amend the Richard B. enacted public laws. To This is a continuing list of subscribe, go to http:// available on the Internet from Russell National School Lunch public bills from the current GPO Access at http:// listserv.gsa.gov/archives/ Act to extend the availability session of Congress which www.access.gpo.gov/nara/ publaws-l.html have become Federal laws. It nara005.html. Some laws may of funds to carry out the fruit may be used in conjunction not yet be available. and vegetable pilot program. Note: This service is strictly with ‘‘PLUS’’ (Public Laws (May 29, 2003; 117 Stat. 774) for E-mail notification of new Update Service) on 202–741– S. 243/P.L. 108–28 laws. The text of laws is not 6043. This list is also Concerning participation of Last List May 30, 2003 available through this service. available online at http:// Taiwan in the World Health PENS cannot respond to www.nara.gov/fedreg/ Organization. (May 29, 2003; specific inquiries sent to this plawcurr.html. 117 Stat. 769) address.

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