Unknown. Affirmation of interim rule as final rule
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--- schema: federal-register doc_type: fedreg source_file: FR-2008-04-28.xml --- 73 82 Monday, April 28, 2008 Contents Agriculture Agriculture Department See Animal and Plant Health Inspection Service See Food Safety and Inspection Service NOTICES Agency Information Collection Activities; Proposals, Submissions, and Approvals, 22918 E8-8791 Alcohol Alcohol and Tobacco Tax and Trade Bureau RULES Certification Requirements for Imported Natural Wine (2005R-002P), 22816-22818 E8-9173 PROPOSED RULES Establishment of the Snipes Mountain Viticultural Area (2007R-300P), 22883-22887 E8-9172 Animal Animal and Plant Health Inspection Service RULES Karnal Bunt Compensation, 22785-22786 E8-9236 Antitrust Antitrust Division NOTICES National Cooperative Research and Production Act of 1993:
Alliance for Sustainable Air Transportation, Inc., 22974-22975 E8-8623 Commerce Commerce Department See International Trade Administration See National Oceanic and Atmospheric Administration See Patent and Trademark Office NOTICES Agency Information Collection Activities; Proposals, Submissions, and Approvals, 22920 E8-9212 Education Education Department NOTICES Proposed Priorities for RRTCs, 22932-22938 E8-9237 Employment Employment and Training Administration NOTICES Solicitation for Grant Applications:
Office of Apprenticeship and the Women's Bureau, 22975 E8-9190 Energy Energy Department See Energy Efficiency and Renewable Energy Office See Energy Information Administration See Federal Energy Regulatory Commission NOTICES Application to Export Electric Energy; Minnesota Power, 22938-22939 E8-9211 Energy Energy Efficiency and Renewable Energy Office NOTICES Meetings: Hydrogen and Fuel Cell Technical Advisory Committee, 22939 E8-9335 Energy Energy Information Administration NOTICES Agency Information Collection Activities;
Proposals, Submissions, and Approvals, 22939-22943 E8-9215 E8-9221 EPA Environmental Protection Agency RULES Metconazole; Pesticide Tolerances, 22823-22828 E8-8971 National Oil and Hazardous Substances Pollution Contingency Plan; National Priorities List, 22828-22831 E8-9077 Withdrawal of Federal Implementation Plans for Clean Air Interstate Rule in 12 States, 22818-22823 E8-9219 PROPOSED RULES Determination of Attainment for the Ozone National Ambient Air Quality Standards for Nonattainment Areas, etc.:
Delaware, District of Columbia, Maryland, Pennsylvania, and Virginia, 22896-22901 E8-9261 Standards of Performance for Coal Preparation Plants, 22901-22913 E8-9104 NOTICES Adequacy Status of the Northern Kentucky Attainment Demonstration 8-Hour Ozone: Motor Vehicle Emission Budgets for Transportation Conformity Purposes, 22943 E8-9244 Proposed Administrative Settlement Pursuant to the Comprehensive Environmental Response Compensation, and Liability Act, 22943-22944 E8-9249 Executive Executive Office of the President See National Drug Control Policy Office See Trade Representative, Office of United States FAA Federal Aviation Administration RULES Airworthiness Directives:
Agusta S.p.A. Model A109A, A109A II, and A109C Helicopters, 22791-22793 E8-8640 Air Tractor, Inc. Models AT-300, et al., 22795-22800 E8-9058 Dornier Luftfahrt GmbH Models 228-200, et al., 22793-22795 E8-9055 MD Helicopters, Inc. Model MD900 Series Helicopters, 22787-22789 E8-8638 Saab Model SAAB Fairchild SF340A (SAAB/SF340A) and SAAB 340B Airplanes, 22789-22791 E8-8663 PROPOSED RULES Airworthiness Directives: Boeing Model 737 Airplanes, 22840-22845 E8-9193 Boeing Model 747 100, 747 100B, etc.
Series Airplanes, 22845-22848 E8-9122 NOTICES Availability of Draft Advisory Circulars, Other Policy Documents and Proposed Technical Standard Orders, 22992 E8-8583 FCC Federal Communications Commission NOTICES Agency Information Collection Activities; Proposals, Submissions, and Approvals, 22944-22948 E8-9093 E8-9178 E8-9233 E8-9234 Rulemaking Proceeding; Petition for Reconsideration of Action, 22948 E8-9179 Federal Emergency Federal Emergency Management Agency NOTICES Agency Information Collection Activities;
Proposals, Submissions, and Approvals, 22964-22967 E8-9208 E8-9223 E8-9238 Disaster Declaration: Arkansas, 22967 E8-9228 Emergency Declaration: Wisconsin, 22967-22968 E8-9229 Federal Energy Federal Energy Regulatory Commission PROPOSED RULES Annual Charges Assessments for Public Utilities; Inquiry Notice, 22867-22871 E8-9199 Modification of Interchange and Transmission Loading Relief Reliability Standards etc., 22856-22867 E8-9013 Standards for Business Practices and Communication Protocols for Public Utilities, 22849-22856 E8-9046 Federal Railroad Federal Railroad Administration NOTICES Petition for Waiver of Compliance, 22992-22993 E8-9204 E8-9207 FTC Federal Trade Commission PROPOSED RULES Guides for Jewelry, Precious Metals, and Pewter Industries, 22848-22849 E8-9171 Food Food and Drug Administration RULES Human Subject Protection:
Foreign Clinical Studies Not Conducted Under an Investigational New Drug Application, 22800-22816 E8-9200 PROPOSED RULES Dental Devices: Classification of Encapsulated Amalgam Alloy and Dental Mercury and Reclassification of Dental Mercury; Issuance of Special Controls for Amalgam Alloy, 22877-22879 08-1187 NOTICES Agency Information Collection Activities; Proposals, Submissions, and Approvals, 22951-22956 E8-9155 E8-9157 E8-9159 Cooperative Agreement to Support the World Health Organization International Programme on Chemical Safety, 22956-22958 E8-9251 Draft Guidance for Industry:
Use of Nucleic Acid Tests to Reduce the Risk of Transmission of West Nile Virus From Donors, etc., 22958-22959 E8-9253 Meetings: Risk Communication Advisory Committee, 22959-22960 E8-9177 Not Withdrawn From Sale for Reasons of Safety or Effectiveness: TAPAZOLE Tablets and 18 Other Drug Products, 22960-22961 E8-9161 Food Food Safety and Inspection Service NOTICES Better Communications, Better Public Health Outcomes: Strategies for Improved Coordination During Foodborne Outbreaks, 22919 E8-9168 Foreign Foreign Assets Control Office NOTICES Foreign Narcotics Kingpin Designation Act;
Additional Designations, 23004 E8-9218 GSA General Services Administration NOTICES Financial Systems Integration Office; Federal Acquisition System Requirements, 22948-22949 E8-9183 Health Health and Human Services Department See Food and Drug Administration See Health Resources and Services Administration NOTICES Agency Information Collection Activities; Proposals, Submissions, and Approvals, 22949-22950 E8-9176 Meeting: Advisory Committee on Blood Safety and Availability, 22950 E8-9230 Meetings:
President's Council on Physical Fitness and Sports, 22950-22951 E8-9232 Health Health Resources and Services Administration NOTICES Statement of Organization, Functions and Delegations of Authority, 22961-22964 E8-9201 Homeland Homeland Security Department See Federal Emergency Management Agency Housing Housing and Urban Development Department NOTICES Agency Information Collection Activities; Proposals, Submissions, and Approvals, 22968-22970 E8-9130 E8-9131 E8-9235 Funding Availability
(NOFA)for 2008 Fiscal Year: Rural Housing and Economic Development Program, 23052-23062 E8-9273 Interior Interior Department See Minerals Management Service See National Park Service See Reclamation Bureau See Surface Mining Reclamation and Enforcement Office IRS Internal Revenue Service PROPOSED RULES Suspension of Running of Period of Limitations During a Proceeding to Enforce or Quash a Designated or Related Summons, 22879-22883 E8-9147 NOTICES Internal Revenue Service Advisory Council Nominations, 23004-23005 E8-9148 International International Trade Administration NOTICES Extension of Time Limit for Preliminary Results of Countervailing Duty: Corrosion-Resistant Carbon Steel Flat Products From the Republic of Korea, 22920 E8-9227 Final Countervailing Duty Determination With Final Antidumping Duty Determination: Sodium Nitrite From the People's Republic of China, 22920-22921 E8-9224 International International Trade Commission NOTICES Meetings; Sunshine Act, 22974 E8-9205 Justice Justice Department See Antitrust Division NOTICES Lodging Consent Decree: Holly Refining & Marketing Co., 22974 E8-9127 Labor Labor Department See Employment and Training Administration See Veterans Employment and Training Service NOTICES Agency Information Collection Activities; Proposals, Submissions, and Approvals, 22975 E8-9191 Maritime Maritime Administration NOTICES Requested Administrative Waiver of the Coastwise Trade Laws, 22993-22994 E8-9255 Minerals Minerals Management Service NOTICES Intent to Establish an Indian Oil Valuation Negotiated Rulemaking Committee, 22970-22972 E8-9248 National Archives National Archives and Records Administration NOTICES Records Schedules; Availability and Request for Comments, 22976-22977 E8-9306 National Credit National Credit Union Administration PROPOSED RULES Low-Income Definition, 22836-22839 E8-8968 Official Advertising Statement, 22839-22840 E8-8967 National Drug National Drug Control Policy Office NOTICES Agency Information Collection Activities; Proposals, Submissions, and Approvals, 22977-22978 E8-9166 National Highway National Highway Traffic Safety Administration PROPOSED RULES Environmental Impact Statement, Notice of Intent: New Corporate Average Fuel Economy Standards; Supplemental, 22913-22917 08-1191 NOAA National Oceanic and Atmospheric Administration RULES Fisheries of the Northeastern United States: Framework Adjustment 5 to the Monkfish Fishery Management Plan, 22831-22835 E8-9116 NOTICES Agency Information Collection Activities; Proposals, Submissions, and Approvals, 22921-22922 E8-9213 Incidental Takes of Marine Mammals During Specified Activities: Shallow Hazard and Site Clearance Surveys in 2008 in the Chukchi Sea, 22922-22931 E8-9264 Marine Mammals; Issuance of Permit Amendment, 22931 E8-9256 Meetings: Pacific Fishery Management Council, 22931-22932 E8-9189 National Park National Park Service PROPOSED RULES National Park System Units in Alaska, 22890-22894 E8-9184 NOTICES National Register of Historic Places; Notification of Pending Nominations and Related Actions, 22972 E8-9153 National Science National Science Foundation NOTICES Meetings: Advisory Committee for GPRA Performance Assessment, 22978 E8-9032 Interagency Arctic Research Policy Committee, 22978 E8-9128 Nuclear Nuclear Regulatory Commission RULES Limited Work Authorizations for Nuclear Power Plants; Correction, 22786-22787 E8-8890 NOTICES Order Imposing Procedures for Access to Sensitive Unclassified Non-Safeguards Information etc.; Hearing: Duke Energy, 22978-22982 E8-9217 Withdrawal of Application for Amendment to Facility; Limerick Generating Station Unit No. 2: Exelon Generation Co., LLC, 22982 E8-9220 National Office of National Drug Control Policy See National Drug Control Policy Office Office of U.S. Trade Office of United States Trade Representative See Trade Representative, Office of United States Patent Patent and Trademark Office PROPOSED RULES Institution of a Fee to File on Paper a Request for Reconsideration of a Final Office Action in a Trademark Case, 22894-22895 E8-9216 Personnel Personnel Management Office RULES Human Resources Management in Agencies, 23012-23049 E8-8661 Reclamation Reclamation Bureau NOTICES Environmental Statements; Availability, etc.: Environmental Water Account, 22972-22973 E8-9202 Meetings: Glen Canyon Dam Adaptive Management Work Group, 22973-22974 E8-9192 SEC Securities and Exchange Commission NOTICES Self-Regulatory Organizations; Proposed Rule Changes: American Stock Exchange LLC, 22983-22987 E8-9187 NASDAQ Stock Market LLC, 22987-22988 E8-9188 SBA Small Business Administration NOTICES Disaster Declaration: Texas, 22988-22989 E8-9144 Meetings: National Small Business Development Center Advisory Board, 22989 E8-9145 Social Social Security Administration PROPOSED RULES Revised Medical Criteria for Evaluating Malignant Neoplastic Diseases, 22871-22877 E8-9170 NOTICES Agency Information Collection Activities; Proposals, Submissions, and Approvals, 22989-22990 E8-9175 State State Department NOTICES Agency Information Collection Activities; Proposals, Submissions, and Approvals, 22990-22991 E8-9239 Culturally Significant Objects Imported for Exhibition Determinations: Pompeii and the Roman Villa, Art and Culture Around the Bay of Naples, 22991 E8-9240 Meetings: Enbridge Energy, Limited Partnership's Proposed Alberta Clipper Project, 22991 E8-9243 Surface Surface Mining Reclamation and Enforcement Office PROPOSED RULES Kansas Regulatory Program, 22887-22890 E8-9194 Surface Surface Transportation Board NOTICES Abandonment Exemption: Union Pacific Railroad Co.; Douglas and Sarpy Counties, NE, 22994 E8-8931 Environmental Impact Statement: Canadian National Railway Company and Grand Trunk Corporation Control - EJ&E West Company, 22994-23003 E8-9214 Release of Waybill Data, 23003-23004 E8-9071 Trade Trade Representative, Office of United States NOTICES Determinations Under the African Growth and Opportunity Act: Gambia, 22983 E8-9150 List of Countries Denying Fair Market Opportunities for Government-Funded Airport Construction Projects, 22983 E8-9222 Transportation Transportation Department See Federal Aviation Administration See Federal Railroad Administration See Maritime Administration See National Highway Traffic Safety Administration See Surface Transportation Board Treasury Treasury Department See Alcohol and Tobacco Tax and Trade Bureau See Foreign Assets Control Office See Internal Revenue Service U.S.-China Economic and Security Review Commission U.S.-China Economic and Security Review Commission NOTICES Public Hearing, 23005-23006 E8-9163 Veterans Veterans Affairs Department NOTICES Agency Information Collection Activities; Proposals, Submissions, and Approvals, 23006-23010 E8-9133 E8-9134 E8-9135 E8-9167 E8-9169 Veterans Veterans Employment and Training Service NOTICES Homeless Veterans’ Reintegration Into Employment, 22975-22976 E8-9065 Separate Parts In This Issue Part II Personnel Management Office, 23012-23049 E8-8661 Part III Housing and Urban Development Department, 23052-23062 E8-9273 Reader Aids Consult the Reader Aids section at the end of this issue for phone numbers, online resources, finding aids, reminders, and notice of recently enacted public laws. To subscribe to the Federal Register Table of Contents LISTSERV electronic mailing list, go to http://listserv.access.gpo.gov and select Online mailing list archives, FEDREGTOC-L, Join or leave the list (or change settings); then follow the instructions. 73 82 Monday, April 28, 2008 Rules and Regulations DEPARTMENT OF AGRICULTURE Animal and Plant Health Inspection Service 7 CFR Part 301 [Docket No. 01-112-2] RIN 0579-AB45 Karnal Bunt Compensation AGENCY: Animal and Plant Health Inspection Service, USDA. ACTION: Affirmation of interim rule as final rule. SUMMARY: We are adopting as a final rule, without change, an interim rule that amended the Karnal bunt regulations to provide compensation for certain growers and handlers of grain and seed affected by Karnal bunt who had not been eligible for compensation, and for certain wheat grown outside the regulated area that had been commingled with wheat grown in regulated areas in Texas. The compensation provided by the interim rule was necessary to encourage the participation of, and obtain cooperation from, affected individuals in our efforts to contain and reduce the prevalence of Karnal bunt. DATES: Effective on April 28, 2008, we are adopting as a final rule the interim rule published at 67 FR 21561-21566 on May 1, 2002. FOR FURTHER INFORMATION CONTACT: Mr. Matthew Royer, Associate Director, Emergency and Domestic Programs, Plant Protection and Quarantine, APHIS, 4700 River Road Unit 137, Riverdale, MD 20737-1231;
(301)734-7819. SUPPLEMENTARY INFORMATION: Background Karnal bunt is a fungal disease of wheat ( *Triticum aestivum* ), durum wheat ( *Triticum durum* ), and triticale ( *Triticum aestivum* X *Secale cereale* ), a hybrid of wheat and rye. Karnal bunt is caused by the fungus *Tilletia indica* (Mitra) Mundkur and is spread primarily through the planting of infected seed. In the absence of measures taken by the U.S. Department of Agriculture
(USDA)to prevent its spread, the establishment of Karnal bunt in the United States could have significant consequences with regard to the export of wheat to international markets. The regulations regarding Karnal bunt are set forth in 7 CFR 301.89-1 through 301.89-16 (referred to below as the regulations). Among other things, the regulations define areas regulated for Karnal bunt and restrict the movement of certain regulated articles, including wheat seed and grain, from the regulated areas. The regulations also provide for the payment of compensation for certain growers, handlers, seed companies, owners of grain storage facilities, flour millers, participants in the National Karnal Bunt Survey, and custom harvesters and owners or lessees of other equipment who incurred losses and expenses because of Karnal bunt during certain years. These provisions are in § 301.89-15, “Compensation for growers, handlers, and seed companies in the 1999-2000 and subsequent crop seasons,” and § 301.89-16, “Compensation for grain storage facilities, flour millers, National Survey participants, and certain custom harvesters and equipment owners or lessees for the 1999-2000 and subsequent crop seasons.” In an interim rule effective and published in the **Federal Register** on May 1, 2002 (67 FR 21561-21566, Docket No. 01-112-1), we amended the Karnal bunt regulations to provide compensation for certain growers and handlers of grain and seed affected by Karnal bunt who had not been eligible for compensation, and for certain wheat grown outside the regulated area that had been commingled with wheat grown in four counties in Texas that had been added to the list of regulated areas. In Archer, Baylor, Throckmorton, and Young Counties, certain wheat growers, handlers, and other parties covered by the compensation regulations had appeared to be ineligible to receive compensation for grain or seed affected by Karnal bunt due to restrictive language in the regulations that did not anticipate certain complications in the harvest and storage of grain that arose following the discovery of Karnal bunt in those counties. Due to the need to quickly declare these counties as regulated areas, we had been unable to modify the compensation regulations at that time to address certain relevant aspects of the way seed and grain were moved, stored, and used in the newly regulated areas. The May 2002 interim rule amended the compensation provisions of the regulations to allow persons affected by these complications in the harvest or storage of grain to apply for compensation. These cases represented unanticipated circumstances applicable only to the 2000-2001 growing season, and we determined that the parties affected should, in fairness, be eligible for compensation. The situations addressed by the interim rule primarily affected growers and handlers in Texas, and certain handlers who moved grain from other States to Texas for storage. We solicited comments on the interim rule for 60 days ending on July 1, 2002. We received 86 comments by that date, from individual custom harvesters and wheat growers and from boards and associations of custom harvesters and wheat growers and marketers. None of these commenters objected to the provisions of the interim rule. Several commenters urged us to provide compensation to custom harvesters whose business was affected by the addition of the four counties as regulated areas. In response to these comments, in an interim rule that was effective and published in the **Federal Register** on May 5, 2004 (69 FR 24909-24016, Docket No. 03-052-1) and in a subsequent final rule that was effective and published in the **Federal Register** on May 9, 2005 (70 FR 24297-24302, Docket No. 03-052-3), we amended the regulations in § 301.89-16 to provide for the payment of compensation to custom harvesters whose mechanized harvesting equipment was used to harvest Karnal bunt-infected host crops in Archer, Baylor, Throckmorton, and Young Counties, TX, during the 2000-2001 crop season and was required to be cleaned and disinfected prior to movement from those counties. (A fuller discussion of the comments we received on this topic can be found in the May 2004 interim rule.) This compensation was intended to reimburse custom harvesters for the cost of that cleaning and disinfection. The May 2004 interim rule also provided for the payment of compensation equivalent to the value of one contract that an eligible custom harvester lost due to the downtime necessitated by cleaning and disinfection. If an eligible custom harvester did not lose a contract due to this downtime, the interim rule provided for the payment of compensation for the fixed costs he or she incurred during the time the machine was being cleaned and disinfected. The May 2004 interim rule also provided for the payment of compensation for the expenses associated with the cleaning and disinfection of other types of equipment used in the four affected counties. The other comments we received did not address the situations addressed by the interim rule. Instead, they addressed the regulations in place before the publication of the interim rule, requesting that APHIS provide additional compensation to parties affected by the Karnal bunt quarantine regulations. Specifically, commenters stated that: • APHIS should pay compensation for wheat grown in quarantined areas; • Compensation for wheat should be based on the market in which the wheat farmer being compensated is accustomed to selling wheat; • Compensation should be provided for acreage within the quarantined areas that would normally be planted with wheat but is left fallow; • APHIS should provide compensation for more than 50 percent of the cost of decontaminating grain storage facilities and raise the $20,000 overall limit on such compensation; and • APHIS should provide greater compensation for seed, since seed prices are 2 to 4 times higher than local grain prices. These comments are outside the scope of the interim rule. The provisions of the regulations addressed by these commenters were added to the regulations in a final rule published in the **Federal Register** on August 6, 2001 (66 FR 40839-40843, Docket No. 96-016-37) that established the compensation levels for the 1999-2000 crop season and subsequent years and made several other changes to the compensation regulations. For the reasons discussed in that final rule, we have determined that the present compensation provisions are appropriate. One commenter stated that APHIS should provide compensation to seed companies and handlers that store uncertified wheat seed that tests spore-positive for Karnal bunt. The regulations in § 301.89-15 provide for compensation for handlers and seed companies who sell wheat grown in an area under the first regulated crop season only if the wheat was not tested by APHIS prior to purchase by the handler or seed company and found positive for Karnal bunt after purchase by the handler or seed company, as long as the price to be paid is not contingent on the test results. Compensation for such wheat will equal the estimated market price for the relevant class of wheat (meaning the type of wheat, such as durum or hard red winter), minus the actual price received by the handler or seed company. Further details are specified in paragraph (a)(2) of § 301.89-15. These provisions were in place during the 2000-2001 crop season, and thus it was not necessary to amend the regulations in the interim rule to accommodate this situation. Therefore, for the reasons given in the interim rule and in this document, we are adopting the interim rule as a final rule without change. This action also affirms the information contained in the interim rule concerning Executive Order 12866 and the Regulatory Flexibility Act, Executive Orders 12372 and 12988, and the Paperwork Reduction Act. Further, this action has been determined to be not significant for the purposes of Executive Order 12866 and, therefore, has not been reviewed by the Office of Management and Budget. List of Subjects in 7 CFR Part 301 Agricultural commodities, Plant diseases and pests, Quarantine, Reporting and recordkeeping requirements, Transportation. PART 301—DOMESTIC QUARANTINE NOTICES Accordingly, we are adopting as a final rule, without change, the interim rule that amended 7 CFR part 301 and that was published at 67 FR 21561-21566 on May 1, 2002. Done in Washington, DC, this 17th day of April 2008. Kevin Shea, Acting Administrator, Animal and Plant Health Inspection Service. [FR Doc. E8-9236 Filed 4-25-08; 8:45 am] BILLING CODE 3410-34-P NUCLEAR REGULATORY COMMISSION 10 CFR Parts 2, 50, 51, 52, and 100 [NRC-2008-0222] RIN 3150-AI05 Limited Work Authorizations for Nuclear Power Plants; Correction AGENCY: Nuclear Regulatory Commission. ACTION: Final rule; correction. SUMMARY: This document corrects a final rule appearing in the **Federal Register** on October 9, 2007 (72 FR 57415), that amended the Nuclear Regulatory Commission's
(NRC)regulations applicable to limited work authorizations (LWAs). This document is necessary to correct erroneous language to the preamble and codified language of the final rule. DATES: The correction is effective April 28, 2008, and is applicable to November 8, 2007. FOR FURTHER INFORMATION CONTACT: Michael T. Lesar, Chief, Rulemaking, Directives, and Editing Branch, Division of Administrative Services, Office of Administrative, U.S. Nuclear Regulatory Commission, Washington, DC 20555-0001, telephone 301-415-7163, e-mail *Michael.Lesar@nrc.gov.* SUPPLEMENTARY INFORMATION: This document corrects erroneous language to the preamble and codified language of the final rule published on October 9, 2007 (72 FR 57415). Also, as published, the final regulations contain errors which may prove to be misleading and need to be clarified. The following corrects the preamble to the October 9, 2007, document. 1. On page 57427, third column, in the first paragraph, the last line is corrected to read as follows: To ensure that the NRC has sufficient information to perform the cumulative impacts analysis in a timely fashion, the final LWA rule includes a requirement, in § 51.45(c), for the environmental report submitted by an applicant for an ESP, LWA, construction permit, or combined license to include a description of impacts of the applicant's preconstruction activities at the proposed site (i.e., the activities listed in a paragraph (2)(i) through (2)(x) in the definition of construction contained in § 51.4), that are necessary to support the construction and operation of the facility which is the subject of the ESP, LWA, construction permit, or combined license application, and an analysis of the cumulative impacts of the activities to be authorized by the ESP, LWA, construction permit, or combined license in light of the preconstruction impacts. 2. On page 57433, third column, the last paragraph is revised to read as follows: Section 51.4 is revised by adding a new definition of “construction,” which is identical to the definition of construction in the revised § 50.10. This makes applicable throughout part 51 the definition of construction in § 50.10. 3. On page 57434, in the first column, the first paragraph is removed. 4. On page 57434, in the first column, the paragraph under § 51.45 is corrected to read as follows: Paragraph
(c)is revised by adding a new requirement requiring environmental reports for ESPs, LWAs, construction permits, and combined licenses to include a description of impacts of the applicant's preconstruction activities at the proposed site (i.e., the activities listed in paragraphs (2)(i) through (2)(x) in the definition of “construction” contained in § 51.4), that are necessary to support the construction and operation of the facility which is the subject of the ESP, LWA, construction permit, or combined license application, and an analysis of the cumulative impacts of the activities to be authorized by the ESP, LWA, construction permit, or combined license in light of the preconstruction impacts. List of Subjects in 10 CFR Part 51 Administrative practice and procedure, Environmental impact statement, Nuclear materials, Nuclear power plants and reactors, Reporting and recordkeeping requirements. For the reasons set out in the preamble and under the authority of the Atomic Energy Act of 1954, as amended; the Energy Reorganization Act of 1974, as amended; and 5 U.S.C. 552 and 553, the NRC is adopting the following amendment to 10 CFR part 51. PART 51—ENVIRONMENTAL PROTECTION REGULATIONS FOR DOMESTIC LICENSING AND RELATED REGULATORY FUNCTIONS 1. The authority citation for part 51 continues to read as follows: Authority: Sec. 161, 68 Stat. 948, as amended, sec. 1701, 106 Stat. 2951, 2952, 2953, (42 U.S.C. 2201, 2297f); secs. 201, as amended, 202, 88 Stat. 1242, as amended, 1244 (42 U.S.C. 5841, 5842); sec. 1704, 112 Stat. 2750 (44 U.S.C. 3504 note). Subpart A also issued under National Environmental Policy Act of 1969, secs. 102, 104, 105, 83 Stat. 853-854, as amended (42 U.S.C. 4332, 4334, 4335); and Pub. L. 95-604, Title II, 92 Stat. 3033-3041; and sec. 193, Pub. L. 101-575, 104 Stat. 2835 (42 U.S.C. 2243). Sections 51.20, 51.30, 51.60, 51.80. and 51.97 also issued under secs. 135, 141, Pub. L. 97-425, 96 Stat. 2232, 2241, and sec. 148, Pub. L. 100-203, 101 Stat. 1330-223 (42 U.S.C. 10155, 10161, 10168). Section 51.22 also issued under sec. 274, 73 Stat. 688, as amended by 92 Stat. 3036-3038 (42 U.S.C. 2021) and under Nuclear Waste Policy Act of 1982, sec. 121, 96 Stat. 2228 (42 U.S.C. 10141). Sections 51.43, 51.67, and 51.109 also issued under Nuclear Waste Policy Act of 1982, sec. 114(f), 96 Stat. 2216, as amended (42 U.S.C. 10134(f)). 2. In § 51.45, paragraph (c), the second complete sentence is corrected to read as follows: § 51.45 Environmental report.
(c)* * * An environmental report prepared at the early site permit stage under § 51.50(b), limited work authorization stage under § 51.49, construction permit stage under § 51.50(a), or combined license stage under § 51.50(c) must include a description of impacts of the preconstruction activities performed by the applicant at the proposed site (i.e., those activities listed in paragraphs (2)(i) through (2)(x) in the definition of “construction” contained in § 51.4), necessary to support the construction and operation of the facility which is the subject of the early site permit, limited work authorization, construction permit, or combined license application. * * * Dated at Rockville, Maryland, this 18th day of April 2008. For the Nuclear Regulatory Commission. Annette L. Vietti-Cook, Secretary of the Commission. [FR Doc. E8-8890 Filed 4-25-08; 8:45 am] BILLING CODE 7590-01-P DEPARTMENT OF TRANSPORTATION Federal Aviation Administration 14 CFR Part 39 [Docket No. FAA-2006-25983; Directorate Identifier 2006-SW-11-AD; Amendment 39-15463; AD 2008-08-11] RIN 2120-AA64 Airworthiness Directives; MD Helicopters, Inc. Model MD900 Series Helicopters AGENCY: Federal Aviation Administration, DOT. ACTION: Final rule. SUMMARY: This amendment adopts a new airworthiness directive
(AD)for MD Helicopters, Inc.
(MDHI)Model MD900 series helicopters that requires modifying the pilot and co-pilot dual-control directional pedal assemblies, or the pilot single-control directional pedal assembly (directional control pedal assembly). This amendment is prompted by an accident which has been attributed to loss of directional control due to failure of the welds in the directional control pedal assembly. The actions specified by this AD are intended to prevent fatigue cracking in the welds that connect the directional control pedal to the pedal shaft, resulting in loss of directional control and subsequent loss of control of the helicopter. DATES: Effective June 2, 2008. The incorporation by reference of certain publications listed in the regulations is approved by the Director of the Federal Register as of June 2, 2008. ADDRESSES: You may get the service information identified in this AD from MD Helicopters, Inc., Attn: Customer Support Division, 4555 E. McDowell Rd., Mail Stop M615, Mesa, Arizona 85215-9734, telephone 1-800-388-3378, fax 480-346-6813, or on the Web at *http://www.mdhelicopters.com* . *Examining the Docket:* You may examine the docket that contains this AD, any comments, and other information on the Internet at *http://www.regulations.gov* or at the Docket Operations office, West Building Ground Floor, Room W12-140, 1200 New Jersey Avenue, SE., Washington, DC. FOR FURTHER INFORMATION CONTACT: Roger Durbin, Aviation Safety Engineer, FAA, Los Angeles Aircraft Certification Office, Airframe Branch, 3960 Paramount Blvd., Lakewood, California 90712, telephone
(562)627-5233, fax
(562)627-5210. SUPPLEMENTARY INFORMATION: A proposal to amend 14 CFR part 39 to include an AD for the specified model helicopters was published in the **Federal Register** on October 17, 2006 (71 FR 60927). That action proposed to require, for MDHI Model MD900 series helicopters, serial numbers (S/N) 900-00008 through 900-00111, 900-00113, and 900-00114, modifying the directional control pedal assembly, part number (P/N) 900C1012007-107, -109, -111, -113, or 900C6012007-111 (pilot dual control); or P/N 900C1012207-105, -107, -109, -111, or -113 (co-pilot dual control); or P/N 900C1010007-107, -109, -111, -113, or 900C6010007-111 (pilot single control), by removing the existing pedals, removing the welded pedal support plate from the pedal shafts, and installing a directional control pedal modification kit, P/N SBK-010. Ink stamping the P/N, 90005340111-101, on the pedal shaft of each modified directional control pedal assembly using permanent ink was also proposed. MDHI has issued Service Bulletin SB900-100, dated April 5, 2006, which describes procedures for modifying the directional control pedal assembly. Interested persons have been afforded an opportunity to participate in the making of this amendment. Due consideration has been given to the comments received. The one commenter, the Modification and Replacement Parts Association, “does not object to the TC holder provided modification kits provided at no cost to operators” and states that “Such action removes any incentive for the development of alternative parts under 14 CFR 21.303.” They also note that the cost impact stated in the AD is $61,650 per helicopter, but should correctly be stated as $61,650 for the entire U.S. fleet of MDHI MD900 helicopters. The FAA concurs and has corrected that error in this AD. After careful review of the available data, including the comments noted above, the FAA has determined that air safety and the public interest require the adoption of the rule with the change described previously. The FAA has determined that this change will neither increase the economic burden on any operator nor increase the scope of the AD. The FAA estimates that this AD will affect 30 helicopters of U.S. registry, and the required actions will take approximately 8 work hours for helicopters with single pilot controls installed, or 16 work hours for helicopters with dual pilot and co-pilot controls installed, at an average labor rate of $80 per work hour. Required parts will cost approximately $775 for helicopters with dual pilot and co-pilot controls installed. Based on these figures, we estimate the total cost impact of the AD on U.S. operators to be $61,650 for the entire fleet, or $2,055 per helicopter, assuming that dual pilot and co-pilot controls are installed on the entire fleet and there is no warranty coverage. Regulatory Findings We have determined that this AD will not have federalism implications under Executive Order 13132. This AD will not have a substantial direct effect on the States, on the relationship between the national Government and the States, or on the distribution of power and responsibilities among the various levels of government. For the reasons discussed above, I certify that the regulation: 1. Is not a “significant regulatory action” under Executive Order 12866; 2. Is not a “significant rule” under the DOT Regulatory Policies and Procedures (44 FR 11034, February 26, 1979); and 3. Will not have a significant economic impact, positive or negative, on a substantial number of small entities under the criteria of the Regulatory Flexibility Act. We prepared an economic evaluation of the estimated costs to comply with this AD. See the AD docket to examine the economic evaluation. Authority for This Rulemaking Title 49 of the United States Code specifies the FAA's authority to issue rules on aviation safety. Subtitle I, Section 106, describes the authority of the FAA Administrator. Subtitle VII, Aviation Programs, describes in more detail the scope of the Agency's authority. We are issuing this rulemaking under the authority described in Subtitle VII, Part A, Subpart III, Section 44701, “General requirements.” Under that section, Congress charges the FAA with promoting safe flight of civil aircraft in air commerce by prescribing regulations for practices, methods, and procedures the Administrator finds necessary for safety in air commerce. This regulation is within the scope of that authority because it addresses an unsafe condition that is likely to exist or develop on products identified in this rulemaking action. List of Subjects in 14 CFR Part 39 Air transportation, Aircraft, Aviation safety, Incorporation by reference, Safety. Adoption of the Amendment Accordingly, pursuant to the authority delegated to me by the Administrator, the Federal Aviation Administration amends part 39 of the Federal Aviation Regulations (14 CFR part 39) as follows: PART 39—AIRWORTHINESS DIRECTIVES 1. The authority citation for part 39 continues to read as follows: Authority: 49 U.S.C. 106(g), 40113, 44701. § 39.13 [Amended] 2. Section 39.13 is amended by adding a new airworthiness directive to read as follows: **2008-08-11 MD Helicopters, Inc.:** Amendment 39-15463. Docket No. FAA-2006-25983; Directorate Identifier 2006-SW-11-AD. Applicability Model MD900 series helicopters, serial numbers (S/N) 900-00008 through 900-00111, 900-00113, and 900-00114, certificated in any category. Compliance Required within 90 days after the effective date of this AD, unless accomplished previously. To prevent fatigue cracking in the welds which connect the pilot and co-pilot dual-control, or pilot single-control directional control pedal (directional control pedal) to the pedal shaft, resulting in loss of directional control and subsequent loss of control of the helicopter, accomplish the following:
(a)Modify each directional control pedal assembly, part number (P/N) 900C1012007-107, -109, -111, -113, or 900C6012007-111 (pilot dual control); or P/N 900C1012207-105, -107, -109, -111, or -113 (co-pilot dual control); or P/N 900C1010007-107, -109, -111, -113, or 900C6010007-111 (pilot single control), by removing the existing pedals, removing the welded pedal support plate from the pedal shafts, and installing a directional control pedal modification kit, P/N SBK-010, in accordance with part 2, Accomplishment Instructions, in MD Helicopters Service Bulletin SB900-100, dated April 5, 2006. One modification kit is required to be installed on helicopters with single controls and two modification kits are required to be installed on helicopters with dual controls.
(b)Using a permanent ink, ink stamp the P/N, 90005340111-101, on the pedal shaft of each modified directional control pedal assembly.
(c)To request a different method of compliance or a different compliance time for this AD, follow the procedures in 14 CFR 39.19. Contact the Manager, Los Angeles Aircraft Certification Office, FAA, ATTN: Roger Durbin, Airframe Branch, 3960 Paramount Blvd., Lakewood, California 90712, telephone
(562)627-5233, fax
(562)627-5210, for information about previously approved alternative methods of compliance.
(d)The modification shall be done in accordance with the specified portions of MD Helicopters Service Bulletin SB900-100, dated April 5, 2006. The Director of the Federal Register approved this incorporation by reference in accordance with 5 U.S.C. 552(a) and 1 CFR part 51. Copies may be obtained from MD Helicopters, Inc., Attn: Customer Support Division, 4555 E. McDowell Rd., Mail Stop M615, Mesa, Arizona 85215-9734, telephone 1-800-388-3378, fax 480-346-6813. Copies may be inspected at the FAA, Office of the Regional Counsel, Southwest Region, 2601 Meacham Blvd., Room 663, Fort Worth, Texas, or at the National Archives and Records Administration (NARA). For information on the availability of this material at NARA, call 202-741-6030, or go to: * http://www.archives.gov/federal_register/ code_of_federal_regulations/ibr_locations.html. *
(e)This amendment becomes effective on June 2, 2008. Issued in Fort Worth, Texas, on April 3, 2008. Mark R. Schilling, Acting Manager, Rotorcraft Directorate, Aircraft Certification Service. [FR Doc. E8-8638 Filed 4-25-08; 8:45 am] BILLING CODE 4910-13-P DEPARTMENT OF TRANSPORTATION Federal Aviation Administration 14 CFR Part 39 [Docket No. FAA-2007-29248; Directorate Identifier 2007-NM-155-AD; Amendment 39-15487; AD 2008-09-06] RIN 2120-AA64 Airworthiness Directives; Saab Model SAAB-Fairchild SF340A (SAAB/SF340A) and SAAB 340B Airplanes AGENCY: Federal Aviation Administration (FAA), Department of Transportation (DOT). ACTION: Final rule. SUMMARY: We are adopting a new airworthiness directive
(AD)for the products listed above. This AD results from mandatory continuing airworthiness information
(MCAI)originated by an aviation authority of another country to identify and correct an unsafe condition on an aviation product. The MCAI describes the unsafe condition as: Subsequent to accidents involving Fuel Tank System explosions in flight * * * and on ground, * * * Special Federal Aviation Regulation 88 (SFAR88) * * * required a safety review of the aircraft Fuel Tank System * * *. Fuel Airworthiness Limitations are items arising from a systems safety analysis that have been shown to have failure mode(s) associated with an `unsafe condition' * * *. These are identified in Failure Conditions for which an unacceptable probability of ignition risk could exist if specific tasks and/or practices are not performed in accordance with the manufacturers' requirements. We are issuing this AD to require actions to correct the unsafe condition on these products. DATES: This AD becomes effective June 2, 2008. The Director of the Federal Register approved the incorporation by reference of a certain publication listed in this AD as of June 2, 2008. ADDRESSES: You may examine the AD docket on the Internet at *http://www.regulations.gov* or in person at the U.S. Department of Transportation, Docket Operations, M-30, West Building Ground Floor, Room W12-140, 1200 New Jersey Avenue, SE., Washington, DC. FOR FURTHER INFORMATION CONTACT: Mike Borfitz, Aerospace Engineer, International Branch, ANM-116, FAA, Transport Airplane Directorate, 1601 Lind Avenue, SW., Renton, Washington 98057-3356; telephone
(425)227-2677; fax
(425)227-1149. SUPPLEMENTARY INFORMATION: Discussion We issued a supplemental notice of proposed rulemaking
(NPRM)to amend 14 CFR part 39 to include an AD that would apply to the specified products. That supplemental NPRM was published in the **Federal Register** on March 6, 2008 (73 FR 12034). That supplemental NPRM proposed to correct an unsafe condition for the specified products. The MCAI states: Subsequent to accidents involving Fuel Tank System explosions in flight * * * and on ground, the FAA published Special Federal Aviation Regulation 88 (SFAR 88) in June 2001. SFAR 88 required a safety review of the aircraft Fuel Tank System to determine that the design meets the requirements of FAR (Federal Aviation Regulation) § 25.901 and § 25.981(a) and (b). A similar regulation has been recommended by the JAA (Joint Aviation Authorities) to the European National Aviation Authorities in JAA letter 04/00/02/07/03-L024 of 3 February 2003. The review was requested to be mandated by NAA's (National Aviation Authorities) using JAR (Joint Aviation Regulation) § 25.901(c), § 25.1309. In August 2005 EASA published a policy statement on the process for developing instructions for maintenance and inspection of Fuel Tank System ignition source prevention (EASA D 2005/CPRO, *www.easa.eu.int/home/cert_policy_statements_en.html* ) that also included the EASA expectations with regard to compliance times of the corrective actions on the unsafe and the not unsafe part of the harmonised design review results. On a global scale the TC (type certificate) holders committed themselves to the EASA published compliance dates (see EASA policy statement). The EASA policy statement has been revised in March 2006: the date of 31-12-2005 for the unsafe related actions has now been set at 01-07-2006. Fuel Airworthiness Limitations are items arising from a systems safety analysis that have been shown to have failure mode(s) associated with an ‘unsafe condition’ as defined in FAA's memo 2003-112-15 `SFAR 88—Mandatory Action Decision Criteria'. These are identified in Failure Conditions for which an unacceptable probability of ignition risk could exist if specific tasks and/or practices are not performed in accordance with the manufacturers' requirements. This EASA Airworthiness Directive mandates the Fuel System Airworthiness Limitations (comprising maintenance/inspection tasks and Critical Design Configuration Control Limitations (CDCCL)) for the type of aircraft, that resulted from the design reviews and the JAA recommendation and EASA policy statement mentioned above. The corrective action is revising the Airworthiness Limitations Section of the Instructions for Continued Airworthiness to incorporate new limitations for fuel tank systems. You may obtain further information by examining the MCAI in the AD docket. Comments We gave the public the opportunity to participate in developing this AD. We received no comments on the NPRM or on the determination of the cost to the public. Conclusion We reviewed the available data and determined that air safety and the public interest require adopting the AD as proposed. Differences Between This AD and the MCAI or Service Information We have reviewed the MCAI and related service information and, in general, agree with their substance. But we might have found it necessary to use different words from those in the MCAI to ensure the AD is clear for U.S. operators and is enforceable. In making these changes, we do not intend to differ substantively from the information provided in the MCAI and related service information. We might also have required different actions in this AD from those in the MCAI in order to follow our FAA policies. Any such differences are highlighted in a NOTE within the AD. Costs of Compliance We estimate that this AD will affect about 144 products of U.S. registry. We also estimate that it will take about 1 work-hour per product to comply with the basic requirements of this AD. The average labor rate is $80 per work-hour. Based on these figures, we estimate the cost of this AD to the U.S. operators to be $11,520, or $80 per product. Authority for This Rulemaking Title 49 of the United States Code specifies the FAA's authority to issue rules on aviation safety. Subtitle I, section 106, describes the authority of the FAA Administrator. “Subtitle VII: Aviation Programs,” describes in more detail the scope of the Agency's authority. We are issuing this rulemaking under the authority described in “Subtitle VII, Part A, Subpart III, Section 44701: General requirements.” Under that section, Congress charges the FAA with promoting safe flight of civil aircraft in air commerce by prescribing regulations for practices, methods, and procedures the Administrator finds necessary for safety in air commerce. This regulation is within the scope of that authority because it addresses an unsafe condition that is likely to exist or develop on products identified in this rulemaking action. Regulatory Findings We determined that this AD will not have federalism implications under Executive Order 13132. This AD will not have a substantial direct effect on the States, on the relationship between the national government and the States, or on the distribution of power and responsibilities among the various levels of government. For the reasons discussed above, I certify this AD: 1. Is not a “significant regulatory action” under Executive Order 12866; 2. Is not a “significant rule” under the DOT Regulatory Policies and Procedures (44 FR 11034, February 26, 1979); and 3. Will not have a significant economic impact, positive or negative, on a substantial number of small entities under the criteria of the Regulatory Flexibility Act. We prepared a regulatory evaluation of the estimated costs to comply with this AD and placed it in the AD docket. Examining the AD Docket You may examine the AD docket on the Internet at *http://www.regulations.gov* ; or in person at the Docket Operations office between 9 a.m. and 5 p.m., Monday through Friday, except Federal holidays. The AD docket contains the NPRM, the regulatory evaluation, any comments received, and other information. The street address for the Docket Operations office (telephone
(800)647-5527) is in the ADDRESSES section. Comments will be available in the AD docket shortly after receipt. List of Subjects in 14 CFR Part 39 Air transportation, Aircraft, Aviation safety, Incorporation by reference, Safety. Adoption of the Amendment Accordingly, under the authority delegated to me by the Administrator, the FAA amends 14 CFR part 39 as follows: PART 39—AIRWORTHINESS DIRECTIVES 1. The authority citation for part 39 continues to read as follows: Authority: 49 U.S.C. 106(g), 40113, 44701. § 39.13 [Amended] 2. The FAA amends § 39.13 by adding the following new AD: **2008-09-06 Saab Aircraft AB:** Amendment 39-15487. Docket No. FAA-2007-29248; Directorate Identifier 2007-NM-155-AD. Effective Date
(a)This airworthiness directive
(AD)becomes effective June 2, 2008. Affected ADs
(b)None. Applicability
(c)This AD applies to all Saab Model SAAB-Fairchild SF340A (SAAB/SF340A) and SAAB 340B airplanes, certificated in any category, all serial numbers. Note 1: This AD requires revisions to certain operator maintenance documents to include new inspections. Compliance with these inspections is required by 14 CFR 91.403(c). For airplanes that have been previously modified, altered, or repaired in the areas addressed by these inspections, the operator may not be able to accomplish the inspections described in the revisions. In this situation, to comply with 14 CFR 91.403(c), the operator must request approval for an alternative method of compliance according to paragraph (g)(1) of this AD. The request should include a description of changes to the required inspections that will ensure the continued operational safety of the airplane. Subject
(d)*Air Transport Association
(ATA)of America Code 28:* Fuel. Reason
(e)The mandatory continuing airworthiness information
(MCAI)states: Subsequent to accidents involving Fuel Tank System explosions in flight * * * and on ground, the FAA published Special Federal Aviation Regulation 88 (SFAR 88) in June 2001. SFAR 88 required a safety review of the aircraft Fuel Tank System to determine that the design meets the requirements of FAR (Federal Aviation Regulation) § 25.901 and § 25.981(a) and (b). A similar regulation has been recommended by the JAA (Joint Aviation Authorities) to the European National Aviation Authorities in JAA letter 04/00/02/07/03-L024 of 3 February 2003. The review was requested to be mandated by NAA's (National Aviation Authorities) using JAR (Joint Aviation Regulation) § 25.901(c), § 25.1309. In August 2005 EASA published a policy statement on the process for developing instructions for maintenance and inspection of Fuel Tank System ignition source prevention (EASA D 2005/CPRO, *www.easa.eu.int/home/cert_policy_statements_en.html* ) that also included the EASA expectations with regard to compliance times of the corrective actions on the unsafe and the not unsafe part of the harmonised design review results. On a global scale the TC (type certificate) holders committed themselves to the EASA published compliance dates (see EASA policy statement). The EASA policy statement has been revised in March 2006: the date of 31-12-2005 for the unsafe related actions has now been set at 01-07-2006. Fuel Airworthiness Limitations are items arising from a systems safety analysis that have been shown to have failure mode(s) associated with an ‘unsafe condition' as defined in FAA's memo 2003-112-15 ‘SFAR 88—Mandatory Action Decision Criteria'. These are identified in Failure Conditions for which an unacceptable probability of ignition risk could exist if specific tasks and/or practices are not performed in accordance with the manufacturers' requirements. This EASA Airworthiness Directive mandates the Fuel System Airworthiness Limitations (comprising maintenance/inspection tasks and Critical Design Configuration Control Limitations (CDCCL)) for the type of aircraft, that resulted from the design reviews and the JAA recommendation and EASA policy statement mentioned above. The corrective action is revising the Airworthiness Limitations Section of the Instructions for Continued Airworthiness to incorporate new limitations for fuel tank systems. Actions and Compliance
(f)Unless already done, do the following actions.
(1)Before December 16, 2008, or within 3 months after the effective date of this AD, whichever occurs earlier, revise the Airworthiness Limitations Section
(ALS)of the Instructions for Continued Airworthiness to incorporate the maintenance and inspection instructions in Part 1 of Saab 340 Fuel Airworthiness Limitations Document 340 LKS 009033, dated February 14, 2006. For all tasks identified in Part 1 of Saab 340 Fuel Airworthiness Limitations Document 340 LKS 009033, dated February 14, 2006, the initial compliance times start from the effective date of this AD, and the repetitive inspections must be accomplished thereafter at the interval specified in Part 1 of Saab 340 Fuel Airworthiness Limitations Document 340 LKS 009033, dated February 14, 2006; except as provided by paragraphs (f)(3) and
(g)of this AD.
(2)Before December 16, 2008, revise the ALS of the Instructions for Continued Airworthiness to incorporate the CDCCLs as defined in Part 2 of Saab 340 Fuel Airworthiness Limitations Document 340 LKS 009033, dated February 14, 2006.
(3)After accomplishing the actions specified in paragraphs (f)(1) and (f)(2) of this AD, no alternative inspection, inspection intervals, or CDCCLs may be used unless the inspections, intervals, or CDCCLs are part of a later revision of Saab 340 Fuel Airworthiness Limitations Document 340 LKS 009033, dated February 14, 2006, that is approved by the Manager, International Branch, ANM-116, Transport Airplane Directorate, FAA, or the European Aviation Safety Agency
(EASA)(or its delegated agent); or unless the inspections, intervals, or CDCCLs are approved as an alternative method of compliance
(AMOC)in accordance with the procedures specified in paragraph (g)(1) of this AD.
(4)Where Saab 340 Fuel Airworthiness Limitations Document 340 LKS 009033, dated February 14, 2006, allows for exceptional short-term extensions, an exception is acceptable to the FAA if it is approved by the appropriate principal inspector in the FAA Flight Standards Certificate Holding District Office. FAA AD Differences Note 2: This AD differs from the MCAI and/or service information as follows: No differences. Other FAA AD Provisions
(g)The following provisions also apply to this AD:
(1)*Alternative Methods of Compliance (AMOCs):* The Manager, International Branch, ANM-116, Transport Airplane Directorate, FAA, has the authority to approve AMOCs for this AD, if requested using the procedures found in 14 CFR 39.19. Send information to ATTN: Mike Borfitz, Aerospace Engineer, International Branch, ANM-116, FAA, Transport Airplane Directorate, 1601 Lind Avenue, SW., Renton, Washington 98057-3356; telephone
(425)227-2677; fax
(425)227-1149. Before using any approved AMOC on any airplane to which the AMOC applies, notify your appropriate principal inspector
(PI)in the FAA Flight Standards District Office (FSDO), or lacking a PI, your local FSDO.
(2)*Airworthy Product:* For any requirement in this AD to obtain corrective actions from a manufacturer or other source, use these actions if they are FAA-approved. Corrective actions are considered FAA-approved if they are approved by the State of Design Authority (or their delegated agent). You are required to assure the product is airworthy before it is returned to service.
(3)*Reporting Requirements:* For any reporting requirement in this AD, under the provisions of the Paperwork Reduction Act, the Office of Management and Budget
(OMB)has approved the information collection requirements and has assigned OMB Control Number 2120-0056. Related Information
(h)Refer to MCAI EASA Airworthiness Directive 2006-0221, dated July 20, 2006; and Saab 340 Fuel Airworthiness Limitations Document 340 LKS 009033, dated February 14, 2006; for related information. Material Incorporated by Reference
(i)You must use Saab 340 Fuel Airworthiness Limitations Document 340 LKS 009033, dated February 14, 2006, to do the actions required by this AD, unless the AD specifies otherwise.
(1)The Director of the Federal Register approved the incorporation by reference of this service information under 5 U.S.C. 552(a) and 1 CFR part 51.
(2)For service information identified in this AD, contact Saab Aircraft AB, SAAB Aircraft Product Support, S-581.88, Linköping, Sweden.
(3)You may review copies at the FAA, Transport Airplane Directorate, 1601 Lind Avenue, SW., Renton, Washington; or at the National Archives and Records Administration (NARA). For information on the availability of this material at NARA, call
(202)741-6030, or go to: *http://www.archives.gov/federal-register/cfr/ibr-locations.html.* Issued in Renton, Washington, on April 15, 2008. Ali Bahrami, Manager, Transport Airplane Directorate, Aircraft Certification Service. [FR Doc. E8-8663 Filed 4-25-08; 8:45 am] BILLING CODE 4910-13-P DEPARTMENT OF TRANSPORTATION Federal Aviation Administration 14 CFR Part 39 [Docket No. FAA-2008-0431; Directorate Identifier 2008-SW-08-AD; Amendment 39-15483; AD 2008-09-03] RIN 2120-AA64 Airworthiness Directives; Agusta S.p.A. Model A109A, A109A II, and A109C Helicopters AGENCY: Federal Aviation Administration (FAA), Department of Transportation (DOT). ACTION: Final rule; request for comments. SUMMARY: We are adopting a new airworthiness directive
(AD)for the specified Agusta S.p.A. (Agusta) model helicopters. This AD results from mandatory continuing airworthiness information
(MCAI)originated by an aviation authority to identify and correct an unsafe condition on an aviation product. The European Aviation Safety Agency (EASA), the Technical Agent for Italy, with which we have a bilateral agreement, states in the MCAI: It has been reported, on an A109A helicopter, a case of failure of the grooved clamp fixing the engine exhaust duct, with the consequent loss of the duct. The duct has hit the main and tail rotor producing the loss of the tail rotor and the emergency landing of the helicopter. The fracture of the grooved clamp was due to excessive loads and corrosion around the attaching rivets. This AD requires actions that are intended to address this unsafe condition. DATES: This AD becomes effective May 13, 2008. The Director of the Federal Register approved the incorporation by reference of Agusta Bollettino Tecnico No. 109-123, dated November 16, 2006, as of May 13, 2008. We must receive comments on this AD by June 27, 2008. ADDRESSES: You may send comments by any of the following methods: • *Federal eRulemaking Portal:* Go to *http://www.regulations.gov* . Follow the instructions for submitting comments. • *Fax:* 202-493-2251. • *Mail:* U.S. Department of Transportation, Docket Operations, M-30, West Building Ground Floor, Room W12-140, 1200 New Jersey Avenue, SE., Washington, DC 20590. • *Hand Delivery:* U.S. Department of Transportation, Docket Operations, M-30, West Building Ground Floor, Room W12-140, 1200 New Jersey Avenue, SE., Washington, DC 20590, between 9 a.m. and 5 p.m., Monday through Friday, except Federal holidays. *Examining the AD Docket:* You may examine the AD docket on the Internet at *http://www.regulations.gov* or in person at the Docket Operations office between 9 a.m. and 5 p.m., Monday through Friday, except Federal holidays. The AD docket contains this AD, the economic evaluation, any comments received, and other information. The street address for the Docket Operations office (telephone
(800)647-5527) is in the ADDRESSES section. Comments will be available in the AD docket shortly after receipt. FOR FURTHER INFORMATION CONTACT: Eric Haight, Aviation Safety Engineer, FAA, Rotorcraft Directorate, Regulations and Guidance Group, Fort Worth, Texas 76193-0111, telephone
(817)222-5204, fax
(817)222-5961. SUPPLEMENTARY INFORMATION: Streamlined Issuance of AD The FAA is implementing a new process for streamlining the issuance of ADs related to MCAI. This streamlined process will allow us to adopt MCAI safety requirements in a more efficient manner and will reduce safety risks to the public. This process continues to follow all FAA AD issuance processes to meet legal, economic, Administrative Procedure Act, and **Federal Register** requirements. We also continue to meet our technical decision-making responsibilities to identify and correct unsafe conditions on U.S.-certificated products. This AD references the MCAI and related service information that we considered in forming the engineering basis to correct the unsafe condition. The AD contains text copied from the MCAI and for this reason might not follow our plain language principles. Discussion EASA, which is the Technical Agent for the aviation authority of Italy, has issued AD No. 2007-0041, dated February 21, 2007 (referred to after this as “the MCAI”), to correct an unsafe condition for this Italian-certificated product. The MCAI states: It has been reported, on an A109A helicopter, a case of failure of the grooved clamp fixing the engine exhaust duct, with the consequent loss of the duct. The duct has hit the main and tail rotor producing the loss of the tail rotor and the emergency landing of the helicopter. The fracture of the grooved clamp was due to excessive loads and corrosion around the attaching rivets. Even though the failed part was on a Model A109A, the Models A109A II and A109C use the same parts. You may obtain further information by examining the MCAI and service information. Relevant Service Information Agusta has issued Bollettino Tecnico No. 109-123, dated November 16, 2006. The actions described in the MCAI are intended to correct the same unsafe condition as that identified in the service information. FAA's Determination and Requirements of This AD These products have been approved by the aviation authority of Italy and are approved for operation in the United States. Pursuant to our bilateral agreement with this State of Design Authority, we have been notified of the unsafe condition described in the MCAI and service information. We are issuing this AD because we evaluated all pertinent information and determined the unsafe condition exists and is likely to exist or develop on other products of these same type designs. Differences Between the AD and the MCAI We have reviewed the MCAI and related service information and, in general, agree with their substance. However, this AD differs from the MCAI as follows:
(1)We refer to flight hours as hours time-in-service (TIS).
(2)We are requiring the initial inspection to be done within the next 20 hours TIS rather than using the date and operating hours specified in the MCAI.
(3)We are not requiring a recurring inspection of the grooved clamps, but we intend to propose to mandate the 300 hour time-in-service or yearly recurring inspection of the grooved clamps through our non-emergency rulemaking procedures. These differences are highlighted in the “Differences Between the FAA AD and the MCAI” section of this AD. Costs of Compliance We estimate that this AD will affect about 59 products of U.S. registry. We also estimate that it will take about 4 work-hours per helicopter to inspect the grooved clamps that attach the engine exhaust ducts. The average labor rate is $80 per work-hour. Required parts cost is negligible. Based on these figures, we estimate the cost of the AD on U.S. operators to be $18,880. FAA's Determination of the Effective Date An unsafe condition exists that requires the immediate adoption of this AD. The FAA has found that the risk to the flying public justifies waiving notice and comment prior to adoption of this rule because we are requiring an inspection within 20 hours time-in-service (TIS), a short time frame. The short inspection time is necessary because of the failure of a grooved clamp attaching the external left side engine exhaust duct and the consequent loss of the exhaust duct that occurred, resulted in an emergency landing. Therefore, we determined that notice and opportunity for public comment before issuing this AD are impracticable and that good cause exists for making this amendment effective in fewer than 30 days. Comments Invited This AD is a final rule that involves requirements affecting flight safety, and we did not precede it by notice and opportunity for public comment. We invite you to send any written relevant data, views, or arguments about this AD. Send your comments to an address listed under the ADDRESSES section. Include “Docket No. FAA-2008-0431; Directorate Identifier 2008-SW-08-AD” at the beginning of your comments. We specifically invite comments on the overall regulatory, economic, environmental, and energy aspects of this AD. We will consider all comments received by the closing date and may amend this AD because of those comments. We will post all comments we receive, without change, to *http://www.regulations.gov,* including any personal information you provide. We will also post a report summarizing each substantive verbal contact we receive about this AD. Authority for This Rulemaking Title 49 of the United States Code specifies the FAA's authority to issue rules on aviation safety. Subtitle I, section 106, describes the authority of the FAA Administrator. “Subtitle VII: Aviation Programs,” describes in more detail the scope of the Agency's authority. We are issuing this rulemaking under the authority described in “Subtitle VII, Part A, Subpart III, Section 44701: General requirements.” Under that section, Congress charges the FAA with promoting safe flight of civil aircraft in air commerce by prescribing regulations for practices, methods, and procedures the Administrator finds necessary for safety in air commerce. This regulation is within the scope of that authority because it addresses an unsafe condition that is likely to exist or develop on products identified in this rulemaking action. Regulatory Findings We determined that this AD will not have federalism implications under Executive Order 13132. This AD will not have a substantial direct effect on the States, on the relationship between the national government and the States, or on the distribution of power and responsibilities among the various levels of government. For the reasons discussed above, I certify this AD: 1. Is not a “significant regulatory action” under Executive Order 12866; 2. Is not a “significant rule” under the DOT Regulatory Policies and Procedures (44 FR 11034, February 26, 1979); and 3. Will not have a significant economic impact, positive or negative, on a substantial number of small entities under the criteria of the Regulatory Flexibility Act. We prepared an economic evaluation of the estimated costs to comply with this AD and placed it in the AD docket. List of Subjects in 14 CFR Part 39 Air transportation, Aircraft, Aviation safety, Incorporation by reference, Safety. Adoption of the Amendment Accordingly, under the authority delegated to me by the Administrator, the FAA amends 14 CFR part 39 as follows: PART 39—AIRWORTHINESS DIRECTIVES 1. The authority citation for part 39 continues to read as follows: Authority: 49 U.S.C. 106(g), 40113, 44701. § 39.13 [Amended] 2. The FAA amends § 39.13 by adding the following new AD: **2008-09-03 Agusta S.p.A.:** Amendment 39-15483. Docket No. FAA-2008-0431; Directorate Identifier 2008-SW-08-AD. Effective Date
(a)This airworthiness directive
(AD)becomes effective on May 13, 2008. Applicability
(b)This AD applies to Model A109A, A109A II, and A109C helicopters, with grooved clamps, part number 4606AC, that attach the engine exhaust ducts, installed, certificated in any category. Reason
(c)The mandatory continued airworthiness information
(MCAI)states: It has been reported, on an A109A helicopter, a case of failure of the grooved clamp fixing the engine exhaust duct, with the consequent loss of the duct. The duct has hit the main and tail rotor producing the loss of the tail rotor and the emergency landing of the helicopter. The fracture of the grooved clamp was due to excessive loads and corrosion around the attaching rivets. Actions and Compliance
(d)Required as indicated, unless already done, do the following:
(1)Within the next 20 hours time-in-service (TIS), remove, clean, and using a 10X or higher magnifying glass, inspect the four grooved clamps that attach the engine exhaust ducts as shown in Figure 1 and by following Steps 3 through 4.2. of the Compliance Instructions of Agusta Bollettino Tecnico No. 109-123, dated November 16, 2006.
(2)If you find a crack or corrosion, before further flight, replace the unairworthy grooved clamp with an airworthy grooved clamp. Differences Between the FAA AD and the MCAI
(e)This AD differs from the MCAI as follows:
(1)We refer to flight hours as hours TIS.
(2)We are requiring the initial inspection to be done within the next 20 hours TIS instead of using the date and operating time specified in the MCAI.
(3)We are not requiring a recurring inspection of the grooved clamps, but we intend to propose to mandate the 300 hour time-in-service or yearly recurring inspection of the grooved clamps through our non-emergency rulemaking procedures.
(f)Air Transport Association of America
(ATA)Code 7800: Engine Exhaust. Other FAA AD Provisions
(g)The following provisions also apply to this AD:
(1)*Alternative Methods of Compliance (AMOCs):* The Manager, Safety Management Group, Rotorcraft Directorate, FAA, has the authority to approve AMOCs for this AD, if requested using the procedures found in 14 CFR 39.19. Send information to ATTN: Eric Haight, Aviation Safety Engineer, Regulations and Guidance Group, Fort Worth, Texas 76193-0111, telephone
(817)222-5204, fax
(817)222-5961.
(2)*Airworthy Product:* Use only FAA-approved corrective actions. Corrective actions are considered FAA-approved if they are approved by the State of Design Authority (or their delegated agent) if the State of Design has an appropriate bilateral agreement with the United States. You are required to assure the product is airworthy before it is returned to service.
(3)*Reporting Requirements:* For any reporting requirement in this AD, under the provisions of the Paperwork Reduction Act, the Office of Management and Budget
(OMB)has approved the information collection requirements and has assigned OMB Control Number 2120-0056. Related Information
(h)EASA Mandatory Continuing Airworthiness Information
(MCAI)AD No. 2007-0041, dated February 21, 2007, contains related information. Material Incorporated by Reference
(i)The Director of the Federal Register approved the incorporation by reference of Agusta Bollettino Tecnico No. 109-123, dated November 16, 2006, under 5 U.S.C. 552(a) and 1 CFR part 51.
(1)For service information identified in this AD, contact Agusta, 21017 Cascina Costa di Samarate
(VA)Italy, Via Giovanni Agusta 520, telephone 39
(0331)229111, fax 39
(0331)229605-222595.
(2)You may review copies of the service information at the FAA, Office of the Regional Counsel, Southwest Region, 2601 Meacham Blvd., Room 663, Fort Worth, Texas or at the National Archives and Records Administration (NARA). For information on the availability of this material at NARA, call
(202)741-6030, or go to: *http://www.archives.gov/federal-register/cfr/ibr-locations.html.* Issued in Fort Worth, Texas, on April 4, 2008. Mark R. Schilling, Acting Manager, Rotorcraft Directorate, Aircraft Certification Service. [FR Doc. E8-8640 Filed 4-25-08; 8:45 am] BILLING CODE 4910-13-P DEPARTMENT OF TRANSPORTATION Federal Aviation Administration 14 CFR Part 39 [Docket No. FAA-2008-0249; Directorate Identifier 2008-CE-012-AD; Amendment 39-15490; AD 2008-09-09] RIN 2120-AA64 Airworthiness Directives; DORNIER LUFTFAHRT GmbH Models 228-200, 228-201, 228-202, and 228-212 Airplanes AGENCY: Federal Aviation Administration (FAA), Department of Transportation (DOT). ACTION: Final rule. SUMMARY: We are adopting a new airworthiness directive
(AD)for the products listed above. This AD results from mandatory continuing airworthiness information
(MCAI)issued by an aviation authority of another country to identify and correct an unsafe condition on an aviation product. The MCAI describes the unsafe condition as: During production testing of a batch of control cables, cracks inside the cable terminal were detected. Despite the specified strength at the date of delivery was achieved, it can not be excluded that the mechanical properties of the cable will degrade. We are issuing this AD to require actions to correct the unsafe condition on these products. DATES: This AD becomes effective June 2, 2008. On June 2, 2008, the Director of the Federal Register approved the incorporation by reference of certain publications listed in this AD. ADDRESSES: You may examine the AD docket on the Internet at *http://www.regulations.gov* or in person at Document Management Facility, U.S. Department of Transportation, Docket Operations, M-30, West Building Ground Floor, Room W12-140, 1200 New Jersey Avenue, SE., Washington, DC 20590. FOR FURTHER INFORMATION CONTACT: Karl Schletzbaum, Aerospace Engineer, FAA, Small Airplane Directorate, 901 Locust, Room 301, Kansas City, Missouri 64106; telephone:
(816)329-4146; fax:
(816)329-4090. SUPPLEMENTARY INFORMATION: Discussion We issued a notice of proposed rulemaking
(NPRM)to amend 14 CFR part 39 to include an AD that would apply to the specified products. That NPRM was published in the **Federal Register** on March 5, 2008 (73 FR 11841). That NPRM proposed to correct an unsafe condition for the specified products. The MCAI states: During production testing of a batch of control cables, cracks inside the cable terminal were detected. Despite the specified strength at the date of delivery was achieved, it can not be excluded that the mechanical properties of the cable will degrade. The MCAI requires replacing rudder control cables, part number (P/N) B-422420A00F delivered with European Aviation Safety Agency
(EASA)Form One tracking number RS52074/05 after January 1, 2006 (also identified by production batch number 1141044, which is printed on the fork end next to the P/N), with FAA-approved serviceable rudder control cables. You may obtain further information by examining the MCAI in the AD docket. Comments We gave the public the opportunity to participate in developing this AD. We received no comments on the NPRM or on the determination of the cost to the public. Conclusion We reviewed the available data and determined that air safety and the public interest require adopting the AD as proposed. Differences Between This AD and the MCAI or Service Information We have reviewed the MCAI and related service information and, in general, agree with their substance. But we might have found it necessary to use different words from those in the MCAI to ensure the AD is clear for U.S. operators and is enforceable. In making these changes, we do not intend to differ substantively from the information provided in the MCAI and related service information. We might also have required different actions in this AD from those in the MCAI in order to follow FAA policies. Any such differences are highlighted in a NOTE within the AD. Costs of Compliance We estimate that this AD will affect about 17 products of U.S. registry. We also estimate that it will take about 15 work-hours per product to comply with the basic requirements of this AD. The average labor rate is $80 per work-hour. Based on these figures, we estimate the cost of this AD on U.S. operators to be $20,400 or $1,200 per product. Authority for This Rulemaking Title 49 of the United States Code specifies the FAA's authority to issue rules on aviation safety. Subtitle I, section 106, describes the authority of the FAA Administrator. “Subtitle VII: Aviation Programs,” describes in more detail the scope of the Agency's authority. We are issuing this rulemaking under the authority described in “Subtitle VII, Part A, Subpart III, Section 44701: General requirements.” Under that section, Congress charges the FAA with promoting safe flight of civil aircraft in air commerce by prescribing regulations for practices, methods, and procedures the Administrator finds necessary for safety in air commerce. This regulation is within the scope of that authority because it addresses an unsafe condition that is likely to exist or develop on products identified in this rulemaking action. Regulatory Findings We determined that this AD will not have federalism implications under Executive Order 13132. This AD will not have a substantial direct effect on the States, on the relationship between the national government and the States, or on the distribution of power and responsibilities among the various levels of government. For the reasons discussed above, I certify this AD:
(1)Is not a “significant regulatory action” under Executive Order 12866;
(2)Is not a “significant rule” under DOT Regulatory Policies and Procedures (44 FR 11034, February 26, 1979); and
(3)Will not have a significant economic impact, positive or negative, on a substantial number of small entities under the criteria of the Regulatory Flexibility Act. We prepared a regulatory evaluation of the estimated costs to comply with this AD and placed it in the AD Docket. Examining the AD Docket You may examine the AD docket on the Internet at *http://www.regulations.gov;* or in person at the Docket Management Facility between 9 a.m. and 5 p.m., Monday through Friday, except Federal holidays. The AD docket contains the NPRM, the regulatory evaluation, any comments received, and other information. The street address for the Docket Office (telephone
(800)647-5527) is in the ADDRESSES section. Comments will be available in the AD docket shortly after receipt. List of Subjects in 14 CFR Part 39 Air transportation, Aircraft, Aviation safety, Incorporation by reference, Safety. Adoption of the Amendment Accordingly, under the authority delegated to me by the Administrator, the FAA amends 14 CFR part 39 as follows: PART 39—AIRWORTHINESS DIRECTIVES 1. The authority citation for part 39 continues to read as follows: Authority: 49 U.S.C. 106(g), 40113, 44701. § 39.13 [Amended] 2. The FAA amends § 39.13 by adding the following new AD: **2008-09-09 DORNIER LUFTFAHRT GmbH:** Amendment 39-15490; Docket No. FAA-2008-0249; Directorate Identifier 2008-CE-012-AD. Effective Date
(a)This airworthiness directive
(AD)becomes effective June 2, 2008. Affected ADs
(b)None. Applicability
(c)This AD applies to Models 228-200, 228-201, 228-202, and 228-212, all serial numbers, that are:
(1)Equipped with rudder control cables, part number (P/N) B-422420A00F delivered with European Aviation Safety Agency
(EASA)Form One tracking number RS52074/05 after January 1, 2006 (also identified by production batch number 1141044, which is printed on the fork end next to the P/N); and
(2)Certificated in any category. Subject
(d)Air Transport Association of America
(ATA)Code 27: Flight Controls. Reason
(e)The mandatory continuing airworthiness information
(MCAI)states: During production testing of a batch of control cables, cracks inside the cable terminal were detected. Despite the specified strength at the date of delivery was achieved, it can not be excluded that the mechanical properties of the cable will degrade. The MCAI AD requires replacing rudder control cables, P/N B-422420A00F delivered with EASA Form One tracking number RS52074/05 after January 1, 2006 (also identified by production batch number 1141044, which is printed on the fork end next to the P/N), with FAA-approved serviceable rudder control cables. Actions and Compliance
(f)Unless already done, do the following actions:
(1)Replace the rudder control cables identified in paragraph (c)(1) of this AD with FAA-approved serviceable rudder control cables following RUAG Aerospace Defence Technology Dornier 228 Alert Service Bulletin No. ASB-228-269, dated March 23, 2007, at whichever of the following occurs first:
(i)Upon reaching 1,200 total hours time-in-service
(TIS)on the rudder control cables identified in paragraph (c)(1) of this AD or within 30 days after June 2, 2008 (the effective date of this AD), whichever occurs later; or
(ii)Within the next 3 months after June 2, 2008 (the effective date of this AD).
(2)As of June 2, 2008 (the effective date of this AD), do not install any rudder control cables, P/N B-422420A00F delivered with EASA Form One tracking number RS52074/05 after January 1, 2006 (also identified by production batch number 1141044, which is printed on the fork end next to the P/N).
(3)Within 30 days after doing the replacement required in paragraph (f)(1) of this AD, return the removed rudder control cables and any held as spares to the manufacturer at the address on RUAG Aerospace Defence Technology Dornier 228 Alert Service Bulletin No. ASB-228-269, dated March 23, 2007. FAA AD Differences Note: This AD differs from the MCAI and/or service information as follows: No differences. Other FAA AD Provisions
(g)The following provisions also apply to this AD:
(1)Alternative Methods of Compliance (AMOCs): The Manager, Standards Staff, FAA, has the authority to approve AMOCs for this AD, if requested using the procedures found in 14 CFR 39.19. Send information to ATTN: Karl Schletzbaum, Aerospace Engineer, FAA, Small Airplane Directorate, 901 Locust, Room 301, Kansas City, Missouri 64106; telephone:
(816)329-4146; fax:
(816)329-4090. Before using any approved AMOC on any airplane to which the AMOC applies, notify your appropriate principal inspector
(PI)in the FAA Flight Standards District Office (FSDO), or lacking a PI, your local FSDO.
(2)Airworthy Product: For any requirement in this AD to obtain corrective actions from a manufacturer or other source, use these actions if they are FAA-approved. Corrective actions are considered FAA-approved if they are approved by the State of Design Authority (or their delegated agent). You are required to assure the product is airworthy before it is returned to service.
(3)Reporting Requirements: For any reporting requirement in this AD, under the provisions of the Paperwork Reduction Act (44 U.S.C. 3501 et seq.), the Office of Management and Budget
(OMB)has approved the information collection requirements and has assigned OMB Control Number 2120-0056. Related Information
(h)Refer to MCAI Luftfahrt-Bundesamt
(LBA)AD No. D-2007-353, dated December 28, 2007, and RUAG Aerospace Defence Technology Dornier 228 Alert Service Bulletin No. ASB-228-269, dated March 23, 2007, for related information. Material Incorporated by Reference
(i)You must use RUAG Aerospace Defence Technology Dornier 228 Alert Service Bulletin No. ASB-228-269, dated March 23, 2007, to do the actions required by this AD, unless the AD specifies otherwise.
(1)The Director of the Federal Register approved the incorporation by reference of this service information under 5 U.S.C. 552(a) and 1 CFR part 51.
(2)For service information identified in this AD, contact RUAG Aerospace Services, Customer Support, P.O. Box 1253, 82231 Wessling, Germany.
(3)You may review copies at the FAA, Central Region, Office of the Regional Counsel, 901 Locust, Room 506, Kansas City, Missouri 64106; or at the National Archives and Records Administration (NARA). For information on the availability of this material at NARA, call 202-741-6030, or go to: *http://www.archives.gov/federal-register/cfr/ibr-locations.html.* Issued in Kansas City, Missouri, on April 18, 2008. David R. Showers, Acting Manager, Small Airplane Directorate, Aircraft Certification Service. [FR Doc. E8-9055 Filed 4-25-08; 8:45 am] BILLING CODE 4910-13-P DEPARTMENT OF TRANSPORTATION Federal Aviation Administration 14 CFR Part 39 [Docket No. FAA-2008-0476; Directorate Identifier 2008-CE-018-AD; Amendment 39-15491; AD 2008-09-10] RIN 2120-AA64 Airworthiness Directives; Air Tractor, Inc. Models AT-300, AT-301, AT-302, AT-400, and AT-400A Airplanes AGENCY: Federal Aviation Administration (FAA), DOT. ACTION: Final rule; request for comments. SUMMARY: The FAA is adopting a new airworthiness directive
(AD)to supersede AD 2003-06-01, which applies to all Air Tractor, Inc. (Air Tractor) Models AT-300, AT-301, AT-302, and AT-400A airplanes that have aluminum spar caps; certain Air Tractor Models AT-400 airplanes that have aluminum spar caps; and all Models AT-300 and AT-301 airplanes that have aluminum spar caps and are or have been converted to turbine power. AD 2003-06-01 requires replacing the wing spar lower caps at a specified safe life limit; allows extending the safe life limit on certain airplanes if a wing lower spar cap splice rework is done; allows a limited time of continued operation beyond the safe life limit provided parts are ordered, the replacement is scheduled, and repetitive inspections reveal no cracks; and requires a report of any cracks found during any inspection to the FAA. This AD results from a recent report of cracks found on a Model AT-301 airplane at hours below the modification time specified in AD 2003-06-01. Consequently, this AD retains the wing spar lower cap replacement and reporting requirements from AD 2003-06-01 and adds a repetitive eddy-current inspection. We are issuing this AD to detect and correct cracks in the wing centerline splice joint. If not detected and corrected, these cracks could result in the wing separating from the airplane during flight. DATES: This AD becomes effective on May 8, 2008. On May 8, 2008, the Director of the Federal Register approved the incorporation by reference of Snow Engineering Co. Service Letter #55, revised October 4, 2004, listed in this AD. As of April 4, 2003, (68 FR 13221, March 19, 2003), the Director of the Federal Register approved the incorporation by reference of Snow Engineering Co. Service Letter #55, revised October 23, 2002, and Snow Engineering Co. Process Specification Number 197, revised June 4, 2002, listed in this AD. We must receive any comments on this AD by June 27, 2008. ADDRESSES: Use one of the following addresses to comment on this AD. • *Federal eRulemaking Portal:* Go to *http://www.regulations.gov* . Follow the instructions for submitting comments. • *Fax:*
(202)493-2251. • *Mail:* U.S. Department of Transportation, Docket Operations, M-30, West Building Ground Floor, Room W12-140, 1200 New Jersey Avenue, SE., Washington, DC 20590. • *Hand Delivery:* U.S. Department of Transportation, Docket Operations, M-30, West Building Ground Floor, Room W12-140, 1200 New Jersey Avenue, SE., Washington, DC 20590, between 9 a.m. and 5 p.m., Monday through Friday, except Federal holidays. To get the service information identified in this AD, contact Air Tractor, Inc., P.O. Box 485, Olney, Texas 76374; telephone:
(940)564-5616; facsimile:
(940)564-5612. To view the comments to this AD, go to *http://www.regulations.gov* . The docket number is FAA-2008-0476; Directorate Identifier 2008-CE-018-AD. FOR FURTHER INFORMATION CONTACT: Rob Romero, Aerospace Engineer, FAA, Fort Worth Airplane Certification Office (ACO), 2601 Meacham Boulevard, Fort Worth, Texas 76193-0150; telephone:
(817)222-5102; facsimile:
(817)222-5960; or Andrew McAnaul, Aerospace Engineer, FAA, Fort Worth ACO (c/o MIDO-43), 10100 Reunion Place, Suite 650, San Antonio, Texas 78216; telephone:
(210)308-3365; facsimile:
(210)308-3370. SUPPLEMENTARY INFORMATION: Discussion An incident on an Air Tractor Model AT-400A where the wing separated from the airplane caused us to issue AD 2002-13-02, Amendment 39-12789 (67 FR 44024, July 1, 2002). Investigation revealed that the right-hand lower spar cap failed due to fatigue at the 3/8 -inch outboard bolt, which is located 6.5 inches outboard of the fuselage centerline. The airplanes affected by AD 2002-13-02 have a similar type design to that of the accident airplane. AD 2002-13-02 required inspecting (one-time) the wing centerline splice joint for cracks and, if any crack was found, replacing the affected wing spar lower cap; reporting the results of the inspection to the FAA; and replacing the wing spar lower caps after a certain amount of usage. The inspection reports submitted to the FAA (as required in AD 2002-13-02) revealed a Model AT-400A airplane with a cracked spar cap. The damage was significant enough to require spar cap replacement. Based on this damage and the results of the inspection reports, we determined that the mandatory replacement time for the wing spar lower cap on the affected turbine engine powered airplanes should be reduced. This prompted us to issue AD 2003-06-01, Amendment 39-13088 (68 FR 13221, March 19, 2003) to supersede AD 2002-13-02. AD 2003-06-01 requires replacing the wing spar lower caps at a specified safe life limit; allows extending the safe life limit on certain airplanes if a wing lower spar cap splice rework is done; allows a limited time of continued operation beyond the safe life limit provided parts are ordered, the replacement is scheduled, and repetitive inspections reveal no cracks; and requires a report of any cracks found during any inspection to the FAA. The FAA recently received a report of cracks found on a Model AT-301 airplane with less hours than the modification time specified in AD 2003-06-01. Based on this incident, we reevaluated the fatigue management plan for the AT-300 and AT-400 series airplanes that have aluminum spar caps without part number 20990-1/-2 steel web plate installed. We have determined that repetitive eddy-current inspections are needed on these airplanes in order to detect any cracks that may develop on the wing spar lower cap before reaching the safe life limit. This condition, if not corrected, could result in the wing separating from the airplane during flight. Relevant Service Information The manufacturer has issued the following service information to address this situation: • Snow Engineering Co. Service Letter #55, revised October 23, 2002, which includes procedures and information for doing the wing lower spar cap splice joint modification rework on all AT-300 and AT-301 series airplanes; • Snow Engineering Co. Service Letter #55, revised October 4, 2004, which includes revised procedures and information for doing the wing lower spar cap splice joint modification rework on all AT-300 and AT-301 series airplanes; and • Snow Engineering Co. Process Specification Number 197, revised June 4, 2002, which provides procedures for accomplishing eddy current inspections of the wing lower spar caps. FAA's Determination and Requirements of This AD We are issuing this AD because we evaluated all the information and determined the unsafe condition described previously is likely to exist or develop on other products of the same type design. This AD supersedes AD 2003-06-01 with a new AD that: • Requires repetitive eddy-current inspections; • Requires you to replace the wing spar lower caps at specified times; • Allows you to extend the time for replacement on certain airplanes if a wing lower spar cap splice rework is done; • Requires you to inspect the wing lower spar cap immediately prior to modification; and • Requires you to report any cracks found during the inspections to the FAA. We are not retaining from AD 2003-06-01 the provision to allow a limited time of continued operation beyond the safe life limit. In preparing this rule, we contacted type clubs and aircraft operators to get technical information and information on operational and economic impacts. We did not receive any information through these contacts. If received, we would have included a discussion of any information that may have influenced this action in the rulemaking docket. FAA's Determination of the Effective Date Since an unsafe condition exists that requires the immediate adoption of this AD, we determined that notice and opportunity for public comment before issuing this AD are impracticable, and that good cause exists for making this amendment effective in fewer than 30 days. Comments Invited This AD is a final rule that involves requirements affecting flight safety, and we did not precede it by notice and an opportunity for public comment. We invite you to send any written relevant data, views, or arguments regarding this AD. Send your comments to an address listed under the ADDRESSES section. Include the docket number “FAA-2008-0476; Directorate Identifier 2008-CE-018-AD” at the beginning of your comments. We specifically invite comments on the overall regulatory, economic, environmental, and energy aspects of the AD. We will consider all comments received by the closing date and may amend the AD in light of those comments. We will post all comments we receive, without change, to *http://www.regulations.gov* , including any personal information you provide. We will also post a report summarizing each substantive verbal contact we receive concerning this AD. Authority for This Rulemaking Title 49 of the United States Code specifies the FAA's authority to issue rules on aviation safety. Subtitle I, Section 106, describes the authority of the FAA Administrator. Subtitle VII, Aviation Programs, describes in more detail the scope of the Agency's authority. We are issuing this rulemaking under the authority described in Subtitle VII, Part A, Subpart III, Section 44701, “General requirements.” Under that section, Congress charges the FAA with promoting safe flight of civil aircraft in air commerce by prescribing regulations for practices, methods, and procedures the Administrator finds necessary for safety in air commerce. This regulation is within the scope of that authority because it addresses an unsafe condition that is likely to exist or develop on products identified in this rulemaking action. Regulatory Findings We determined that this AD will not have federalism implications under Executive Order 13132. This AD will not have a substantial direct effect on the States, on the relationship between the national government and the States, or on the distribution of power and responsibilities among the various levels of government. For the reasons discussed above, I certify that this AD:
(1)Is not a “significant regulatory action” under Executive Order 12866;
(2)Is not a “significant rule” under DOT Regulatory Policies and Procedures (44 FR 11034, February 26, 1979); and
(3)Will not have a significant economic impact, positive or negative, on a substantial number of small entities under the criteria of the Regulatory Flexibility Act. We prepared a regulatory evaluation of the estimated costs to comply with this AD and placed it in the AD docket. Examining the AD Docket You may examine the AD docket that contains the AD, the regulatory evaluation, any comments received, and other information on the Internet at *http://www.regulations.gov;* or in person at the Docket Management Facility between 9 a.m. and 5 p.m., Monday through Friday, except Federal holidays. The Docket Office (telephone
(800)647-5527) is located at the street address stated in the ADDRESSES section. Comments will be available in the AD docket shortly after receipt. List of Subjects in 14 CFR Part 39 Air transportation, Aircraft, Aviation safety, Incorporation by reference, Safety. Adoption of the Amendment Accordingly, under the authority delegated to me by the Administrator, the FAA amends 14 CFR part 39 as follows: PART 39—AIRWORTHINESS DIRECTIVES 1. The authority citation for part 39 continues to read as follows: Authority: 49 U.S.C. 106(g), 40113, 44701. § 39.13 [Amended] 2. The FAA amends § 39.13 by removing Airworthiness Directive
(AD)2003-06-01, Amendment 39-13088 (68 FR 13221, March 19, 2003), and by adding a new AD to read as follows: **2008-09-10 Air Tractor, Inc.:** Amendment 39-15491; Docket No. FAA-2008-0476; Directorate Identifier 2008-CE-018-AD. Effective Date
(a)This AD becomes effective on May 8, 2008. Affected ADs
(b)This AD supersedes AD 2003-06-01, Amendment 39-13088. Applicability
(c)This AD applies to the following airplanes that are certificated in any category:
(1)Models AT-300, AT-301, AT-302, and AT-400A airplanes, all serial numbers, that have aluminum spar caps;
(2)Models AT-400 airplanes, serial numbers 400-0244 through 400-0415, that have aluminum spar caps; and
(3)Models AT-300 and AT-301 airplanes, all serial numbers that have aluminum spar caps and are or have been converted to turbine power. Unsafe Condition
(d)This AD is the result of service reports and analysis done on wing lower spar caps of Air Tractor, Inc. airplanes. The actions specified by this AD are intended to prevent fatigue cracks from occurring in the wing lower spar cap before the established safe life is reached. Fatigue cracks in the wing lower spar cap, if not detected and corrected, could result in failure of the spar cap and lead to wing separation and loss of control. Compliance
(e)To address this problem, you must do the following, unless already done:
(1)For all affected airplanes without steel web plates, part numbers (P/N) 20990-1 or 20990-2, or steel spar caps installed, eddy-current inspect the left and right wing spar lower cap outboard holes for cracks following Snow Engineering Co. Process Specification #197, revised June 4, 2002. Do the inspections at the following compliance times: Affected airplanes Initial compliance time Repetitive compliance time
(i)For all airplanes Initially inspect upon reaching 3,500 total hours time-in-service
(TIS)on the wing spar lower cap or within the next 10 hours TIS after May 8, 2008 (the effective date of this AD), whichever occurs later Repetitively inspect thereafter at intervals not to exceed 450 hours TIS until the wing spar center splice joint modification or the required wing spar lower cap replacement. After each replacement, initially inspect upon reaching 3,500 total hours TIS on either wing spar lower cap, and repetitively inspect thereafter at intervals not to exceed 450 hours TIS until the wing spar center splice joint modification or the required wing spar lower cap replacement.
(ii)Airplanes that have had an eddy-current inspection done on the wing spar lower cap within the last 450 hours TIS before the effective date of this AD You may take credit for that inspection. Continue with the required repetitive inspection intervals Repetitively inspect thereafter at intervals not-to-exceed 450 hours TIS from the time of the last inspection until the wing spar center splice joint modification or the required wing spar lower cap replacement. After each replacement, initially inspect upon reaching 3,500 total hours TIS on either wing spar lower cap, and repetitively inspect thereafter at intervals not to exceed 450 hours TIS until the wing spar center splice joint modification or the required wing spar lower cap replacement.
(2)For all affected Models AT-300 and AT-301 airplanes with reciprocating engines, the 450-hour repetitive inspections required in this AD are terminated after the wing spar center splice joint modification is incorporated in accordance with paragraph
(g)of this AD or when the wing lower spar caps are replaced. The replacement specified in paragraph (f)(2) of this AD is still applicable.
(3)If cracks are found during any inspection required in paragraphs (e)(1)(i), (e)(1)(ii), or (g)(2) of this AD, replace the wing lower spar cap before further flight.
(f)Replace each wing lower spar cap in accordance with the applicable maintenance manual, as follows: Affected airplanes Initial replacement compliance time Repetitive replacement/inspection compliance time
(1)For all affected Models AT-300 and AT-301 airplanes with reciprocating engines and that do not incorporate the wing spar center splice joint modification Upon reaching 5,000 total hours TIS on either wing spar lower cap or within the next 25 hours TIS after April 4, 2003 (the effective date of AD 2003-06-01), whichever occurs later Replace each time the safe life limit of 5,000 total hours TIS on either wing spar lower cap is reached. After each replacement, inspect as specified in paragraph (e)(1) of this AD until the wing spar center splice joint modification or the required wing spar lower cap replacement.
(2)For all affected Models AT-300 and AT-301 airplanes with reciprocating engines that do incorporate the wing spar center splice joint modification done in accordance paragraph
(g)of this AD Upon reaching the safe life limit of 7,000 total hours TIS on either wing spar lower cap or within the next 25 hours TIS after April 4, 2003 (the effective date of AD 2003-06-01), whichever occurs later Replace each time the safe life limit of 7,000 total hours TIS on either wing spar lower cap is reached. After each replacement, inspect as specified in paragraph (e)(1) of this AD until the wing spar center splice joint modification or the required wing spar lower cap replacement.
(3)For all affected AT-302, AT-400, and AT-400A airplanes with aluminum spar caps; and all affected Models AT-300 and AT-301 airplanes with aluminum spar caps that are or have ever been converted to turbine power Upon reaching 4,450 total hours TIS on either wing spar lower cap or within the next 25 hours TIS after April 4, 2003 (the effective date of AD 2003-06-01), whichever occurs later Replace each time the safe life limit of 4,450 total hours TIS on the wing spar lower cap is reached. After each replacement inspect as specified in paragraph (e)(1) of this AD until the required wing spar lower cap replacement.
(g)For airplanes specified in paragraph (f)(1) of this AD, you may extend the safe life limit of the wing spar lower cap to 7,000 hours TIS by incorporating the wing spar center splice joint modification following the procedures in Snow Engineering Co. Service Letter #55, revised October 23, 2002; or Snow Engineering Co. Service Letter #55, revised October 4, 2004, with the following requirements:
(1)This modification must be done no earlier than 4,600 total hours TIS on the wing spar lower cap and no later than 5,000 total hours TIS on the wing spar lower cap.
(2)Immediately before incorporating the modification, you must do an eddy-current inspection for cracks following Snow Engineering Co. Process Specification #197, revised June 4, 2002.
(3)After each replacement, inspect as specified in paragraph (e)(1) of this AD until the wing spar center splice joint modification or the required wing spar lower cap replacement.
(h)Eddy-current inspections required by this AD must be done by one of the following:
(1)A level 2 or 3 inspector certified in eddy-current inspection using the guidelines established by the American Society for Nondestructive Testing or NAS 410; or
(2)A person authorized to perform AD maintenance work and who has completed and passed the Air Tractor, Inc. training course on eddy-current inspection on wing lower spar caps. Note 1: We are not retaining from AD 2003-06-01 the provision to allow a limited time of continued operation beyond the safe life limit provided parts are ordered, the replacement is scheduled, and repetitive inspections reveal no cracks. That provision was put in AD 2003-06-01 to prevent airplanes from being inadvertently grounded if parts were not available. If parts availability were to ever become a problem in the future, the owner/operator could request an alternative method of compliance following the procedures in 14 CFR 39.19 and this AD.
(i)Report the results of any inspection required by this AD where cracks are found to the FAA.
(1)Submit this report within 10 days after the inspection.
(2)Use the form (Figure 1 of this AD) and submit it to FAA, Fort Worth Airplane Certification Office (ACO), 2601 Meacham Boulevard, Fort Worth, Texas 76193-0150; telephone:
(817)222-5156; facsimile:
(817)222-5960.
(3)The Office of Management and Budget
(OMB)approved the information collection requirements contained in this regulation under the provisions of the Paperwork Reduction Act of 1980 (44 U.S.C. 3501 *et seq.* ) and assigned OMB Control Number 2120-0056. BILLING CODE 4910-13-P ER28ap08.001 BILLING CODE 4910-13-C Alternative Methods of Compliance (AMOCs)
(j)The Manager, Fort Worth ACO, FAA, has the authority to approve AMOCs for this AD, if requested using the procedures found in 14 CFR 39.19. Send information to ATTN: Rob Romero, Aerospace Engineer, FAA, Fort Worth ACO, 2601 Meacham Boulevard, Fort Worth, Texas 76193-0150; telephone:
(817)222-5102; facsimile:
(817)222-5960; or Andrew McAnaul, Aerospace Engineer, ASW-150 (c/o MIDO-43), 10100 Reunion Place, Suite 650, San Antonio, Texas 78216; telephone:
(210)308-3365; facsimile:
(210)308-3370. Before using any approved AMOC on any airplane to which the AMOC applies, notify your appropriate principal inspector
(PI)in the FAA Flight Standards District Office (FSDO), or lacking a PI, your local FSDO.
(k)AMOCs approved for AD 2003-06-01 are approved for this AD. Special Flight Permit
(l)Under 14 CFR part 39.23, we are limiting the special flight permits for this AD by the following conditions:
(1)Operate only in day visual flight rules (VFR).
(2)Ensure that the hopper is empty.
(3)Limit airspeed to 135 miles per hour
(mph)indicated airspeed (IAS).
(4)Avoid any unnecessary g-forces.
(5)Avoid areas of turbulence.
(6)Plan the flight to follow the most direct route. Material Incorporated by Reference
(m)You must use Snow Engineering Co. Service Letter #55, revised October 23, 2002; Snow Engineering Co. Service Letter #55, revised October 4, 2004; and Snow Engineering Co. Process Specification Number 197, revised June 4, 2002, to do the actions required by this AD, unless the AD specifies otherwise.
(1)The Director of the Federal Register approved the incorporation by reference of Snow Engineering Co. Service Letter #55, revised October 4, 2004, under 5 U.S.C. 552(a) and 1 CFR part 51.
(2)On April 4, 2003, (68 FR 13221, March 19, 2003), the Director of the Federal Register approved the incorporation by reference of Snow Engineering Co. Service Letter #55, revised October 23, 2002, and Snow Engineering Process Specification Number 197, revised June 4, 2002.
(3)For service information identified in this AD, contact Tractor, Inc., P.O. Box 485, Olney, Texas 76374.
(4)You may review copies at the FAA, Central Region, Office of the Regional Counsel, 901 Locust, Kansas City, Missouri 64106; or at the National Archives and Records Administration (NARA). For information on the availability of this material at NARA, call 202-741-6030, or go to: *http://www.archives.gov/federal_register/code_of_federal_regulations/ibr_locations.html* . Issued in Kansas City, Missouri, on April 18, 2008. David R. Showers, Acting Manager, Small Airplane Directorate, Aircraft Certification Service. [FR Doc. E8-9058 Filed 4-25-08; 8:45 am] BILLING CODE 4910-13-P DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration 21 CFR Part 312 [Docket No. 2004N-0018] Human Subject Protection; Foreign Clinical Studies Not Conducted Under an Investigational New Drug Application AGENCY: Food and Drug Administration, HHS. ACTION: Final rule. SUMMARY: The Food and Drug Administration
(FDA)is amending its regulations on acceptance of foreign clinical studies not conducted under an investigational new drug application
(IND)(non-IND foreign clinical studies) as support for an IND or application for marketing approval for a drug or biological product. The final rule replaces the requirement that these studies be conducted in accordance with ethical principles stated in the Declaration of Helsinki (Declaration) issued by the World Medical Association (WMA), specifically the 1989 version (1989 Declaration), with a requirement that the studies be conducted in accordance with good clinical practice (GCP), including review and approval by an independent ethics committee (IEC). The final rule updates the standards for the acceptance of foreign clinical studies not conducted under an IND and helps ensure the protection of human subjects and the quality and integrity of data obtained from these studies. DATES: This rule is effective October 27, 2008. FOR FURTHER INFORMATION CONTACT: Janet Norden, Office of Medical Policy, Center for Drug Evaluation and Research, Food and Drug Administration, 10903 New Hampshire Ave., Bldg. 22, rm. 4200, Silver Spring, MD 20993-0002, 301-796-2270; and Stephen Ripley, Center for Biologics Evaluation and Research (HFM-17), Food and Drug Administration, 1401 Rockville Pike, suite 200N, Rockville, MD 20852-1448, 301-827-6210. SUPPLEMENTARY INFORMATION: Table of Contacts I. Background II. Overview of the Final Rule, Including Changes to the Proposed Rule A. Acceptance of Studies B. Supporting Information C. Waivers D. Records III. Comments on the Proposed Rule A. Replacement of the Declaration With GCP B. Definition of Independent Ethics Committee C. Local Laws and Regulations D. Acceptance of Studies E. Definition of Good Clinical Practice F. IEC Review and Approval G. Onsite Inspection H. Data From Studies Not Conducted in Accordance With GCP I. Supporting Information 1. General Comments 2. Investigator Qualifications and Description of Research Facilities 3. Detailed Summary of Protocol and Results of the Study 4. Names and Qualifications of IEC Members 5. Summary of the IEC's Decision 6. Description of Informed Consent Process 7. Description of Incentives to Subjects 8. Description of Study Monitoring 9. Description of Investigator Training and Signed Written Commitments J. Waivers IV. Implementation V. Legal Authority VI. Paperwork Reduction Act of 1995 VII. Environmental Impact VIII. Federalism IX. Analysis of Economic Impacts A. Objectives of the Final Rule B. Background on Current Situation Regarding Foreign Studies C. The Final Rule D. Costs of the Final Rule E. Benefits of the Final Rule F. Small Business Impact 1. Nature of the Impact 2. The Affected Industry 3. Alternatives to the Final Rule 4. Outreach 5. Conclusion G. References I. Background In the **Federal Register** of June 10, 2004 (69 FR 32467), we published a proposed rule that would revise our regulations in part 312 (21 CFR part 312) on the conditions under which we will accept non-IND foreign clinical studies as support for an IND, a new drug application (NDA), or a biologics license application (BLA). As discussed in section III.A of this document, we revised the language used to refer to an application (other than an IND) that may be supported by non-IND foreign clinical studies from “NDA or BLA” or “marketing application” to “application for marketing approval,” which we define as an application under section 505 of the Federal Food, Drug, and Cosmetic Act (the act) (21 U.S.C. 355) or section 351 of the Public Health Service Act (the PHS Act) (42 U.S.C. 262), to make it clear that the regulation also applies to foreign clinical studies supporting abbreviated new drug applications (ANDAs). Previous § 312.120(a) stated that we generally accepted for review non-IND foreign clinical studies provided they were well designed, well conducted, performed by qualified clinical investigators, and conducted in accordance with ethical principles acceptable to the world community. With respect to such ethical principles, § 312.120(c)(1) stated that for a foreign clinical study not conducted under an IND to be used to support an IND or application for marketing approval, the study must have been conducted in accordance with the ethical principles stated in the 1989 Declaration or the laws and regulations of the country in which the research was conducted, whichever represents the greater protection of the individual. Section 312.120(c)(4) set forth the text of the 1989 Declaration. We proposed to replace the requirement that non-IND foreign clinical studies be conducted in accordance with ethical principles stated in the 1989 Declaration with a requirement that the studies be conducted in accordance with GCP. We proposed to define GCP as a standard for the design, conduct, performance, monitoring, auditing, recording, analysis, and reporting of clinical trials in a way that provides assurance that the data and reported results are credible and accurate, and that the rights, safety, and well-being of trial subjects are protected. GCP also would include review and approval by an IEC before initiating a study, continuing IEC review of ongoing studies, and obtaining and documenting freely given informed consent of study subjects. In the preamble to the proposed rule, we provided several reasons for our proposed change in requirements for non-IND foreign clinical studies. First, we noted that standards for protecting human subjects have evolved considerably over the past decade, as evidenced by revisions of the Declaration by the WMA's General Assembly and the issuance of several documents by the International Conference on Harmonisation of Technical Requirements for Registration of Pharmaceuticals for Human Use (ICH). We noted that the ICH document “E6 Good Clinical Practice: Consolidated Guideline” (ICH E6), which we adopted for use as guidance for industry in 1997 (62 FR 25692, May 9, 1997), includes a definition of GCP that shares many important ethical principles with the 1989 Declaration. 1 However, we stated that the concept of GCP in ICH E6 provides more detail and enumeration of specific responsibilities of various parties, including monitoring of the trial and reporting adverse events. Although we did not specifically incorporate ICH E6 into the proposed revision of § 312.120, we stated that the standard of GCP that we proposed for § 312.120 was consistent with that in ICH E6 and was sufficiently flexible to accommodate differences in how countries regulate the conduct of clinical research and obtain informed consent, while helping to ensure adequate and comparable human subject protection. 1 ICH E6 and other FDA guidances adopted from the ICH are available electronically at *http://www.fda.gov/cder/guidance/index.htm* . Another reason we stated for proposing to revise § 312.120 was that the adoption of a GCP requirement for non-IND foreign clinical studies would help provide greater assurance of the quality of the data obtained from these studies. Although the Declaration states that it is unethical to enroll human subjects in poorly designed or conducted clinical trials, it does not provide guidance on how to ensure proper conduct of trials. We proposed the GCP provisions to help ensure data quality and integrity by, among other things, specifying that GCP includes providing assurance that data are credible and accurate and requiring the submission of information on study monitoring and conformance with protocols. Finally, we stated that deleting the reference in § 312.120 to the Declaration was necessary to eliminate the potential for confusion about the requirements for non-IND foreign clinical studies that could result from potential revisions of the Declaration. We noted that the Declaration is a document that is subject to change independent of FDA authority and, therefore, could be modified to contain provisions that are inconsistent with U.S. laws and regulations. We further noted that although revisions to the Declaration could not supersede U.S. laws and regulations, the changes might be confusing for sponsors. We received 32 comments on the proposed rule, which we address in section III of this document. II. Overview of the Final Rule, Including Changes to the Proposed Rule We are revising our regulations in § 312.120 on the conditions under which we will accept as support for an IND or application for marketing approval (an application under section 505 of the act or section 351 of the PHS Act) a foreign clinical study not conducted under an IND. A. Acceptance of Studies Under revised § 312.120(a)(1), we will accept as support for an IND or application for marketing approval a well-designed, well-conducted, non-IND foreign clinical study if it was conducted in accordance with GCP and we are able to validate the data from the study through an onsite inspection, if necessary. Under § 312.120(a)(1)(i), GCP is defined as a standard for the design, conduct, performance, monitoring, auditing, recording, analysis, and reporting of clinical trials in a way that provides assurance that the data and reported results are credible and accurate and that the rights, safety, and well-being of trial subjects are protected. GCP includes review and approval (or provision of a favorable opinion) by an IEC before initiating a study, continuing review of an ongoing study by an IEC, and obtaining and documenting the freely given informed consent of the subject (or a subject's legally authorized representative, if the subject is unable to provide informed consent) before initiating a study. (An IEC is defined in § 312.3 as a review panel that is responsible for ensuring the protection of the rights, safety, and well-being of human subjects involved in a clinical investigation and is adequately constituted to provide assurance of that protection.) GCP does not require informed consent in life-threatening situations under limited circumstances, as specified in § 312.120(a)(1)(i). Section 312.120(a)(2) states that although we will not accept as support for an IND or application for marketing approval a study that does not meet the conditions in § 312.120(a)(1), we will examine data from such a study. We will do so because we require the submission of such data under applicable regulations for drugs and biologics (e.g., §§ 314.50, 314.80, 600.80, 601.2 (21 CFR 314.50, 314.80, 600.80, 601.2)) and because the data may have a bearing on the safety of a drug. B. Supporting Information The final rule revises the regulations on the information that a sponsor or applicant who wishes to rely on a non-IND foreign clinical study to support an IND or application for marketing approval must submit to us to demonstrate that the study conformed to GCP. In response to comments, we revised § 312.120(b) to make clear that a sponsor or applicant is not required to duplicate information already submitted in the IND or application for marketing approval. Instead, the sponsor or applicant may either submit the supporting information listed in § 312.120(b) or provide a cross reference to another section of the submission where the information is located (see comment 21 of this document). Under § 312.120(b), the sponsor or applicant must submit the information described in paragraphs (b)(1) through (b)(11). In response to comments, we changed the information requirements in § 312.120(b)(6) and (b)(11) of the proposed rule as noted in the following description. Under § 312.120(b), the sponsor or applicant must submit the following information: • The investigator's qualifications (§ 312.120(b)(1)). • A description of the research facilities (§ 312.120(b)(2)). • A detailed summary of the protocol and study results and, if we request, case records or additional background data (§ 312.120(b)(3)). • A description of the drug substance and drug product, including the components, formulation, specifications, and, if available, the bioavailability of the drug product (§ 312.120(b)(4)). • Information showing that the study is adequate and well controlled (if the study is intended to support the effectiveness of a drug product) (§ 312.120(b)(5)). • The name and address of the IEC that reviewed the study and a statement that the IEC meets the definition in § 312.3 (records supporting the statement, including the names and qualifications of IEC members, must be maintained by the sponsor or applicant and be available for agency review) (§ 312.120(b)(6)). (The proposed rule would have required submission to FDA of the names and qualifications of the IEC members that reviewed the study (see comment 25 of this document).) • A summary of the IEC's decision to approve or modify and approve the study, or to provide a favorable opinion (§ 312.120(b)(7)). • A description of how informed consent was obtained (§ 312.120(b)(8)). • A description of what incentives, if any, were provided to subjects to participate (§ 312.120(b)(9)). • A description of how the sponsors monitored the study and ensured that the study was consistent with the protocol (§ 312.120(b)(10)). • A description of how investigators were trained to comply with GCP and to conduct the study in accordance with the study protocol, and a statement on whether written commitments by investigators to comply with GCP and the protocol were obtained (any signed commitments must be maintained and available for agency review) (§ 312.120(b)(11)). (The proposed rule would have required sponsors and applicants to submit copies of any written commitments (see comment 32 of this document).) C. Waivers The final rule includes a provision (§ 312.120(c)) under which a sponsor or applicant may request that we waive any requirement in § 312.120(a)(1) or (b). D. Records In response to comments, we included in the final rule a provision on record retention requirements. Section 312.120(d) states that a sponsor or applicant must retain the records required by § 312.120 for 2 years after the agency's decision on an application for marketing approval for a drug or, if a study is submitted in support of an IND but not an application for marketing approval, for 2 years after the submission of the IND. The requirement to maintain appropriate records was implicit in the requirement, in proposed § 312.120(a)(1)(ii), that FDA be able to validate the data from a study through an onsite inspection if necessary, and under the proposed rule, the record retention requirements of § 312.57(c) would have applied to non-IND foreign clinical studies. However, we have concluded that it is appropriate to set forth record retention requirements specifically for these studies in § 312.120(d) (see comment 24 of this document). III. Comments on the Proposed Rule We received 32 comments on the proposed rule. Comments were received from manufacturers, trade associations, advocacy groups, foreign bioethics organizations, and individual health care providers, researchers, and consumers. Summaries of the comments received and our responses follow: A. Replacement of the Declaration With GCP Section 312.120(a)(1)(i) of the proposed rule stated that we would accept as support for an IND or application for marketing approval a well-designed and well-conducted foreign clinical study not conducted under an IND if the study was conducted in accordance with GCP. The requirement for conducting a study in accordance with GCP would replace the former requirement in § 312.120(c)(1) that such a study be conducted in accordance with the ethical principles stated in the 1989 Declaration or the laws and regulations of the country in which the research was conducted, whichever represents the greater protection of the individual. At our own initiative, we revised the language used to refer to an application (other than an IND) that may be supported by non-IND foreign clinical studies to “application for marketing approval” instead of “NDA or BLA” or “marketing application.” Under § 312.120(a)(1), we further clarified that an “application for marketing approval” means “an application under section 505 of the act or section 351 of the * * * PHS Act.” Applications for marketing approval under section 505 of the act include both NDAs and ANDAs. The phrase “application for marketing approval” tracks the language used in previous § 312.120. We made these revisions to avoid speculation that this final rule differed in scope from previous § 312.120, which was not our intention. (Comment 1) Several comments expressed support for adoption of the GCP requirement and deletion of the reference to the Declaration, for the following reasons: • The proposed changes are appropriate measures to improve public assurance of the quality of the science and ethics supporting data for non-IND studies. • Relying on GCP reflects the adoption of ICH E6 as a global standard for the conduct of sponsored clinical research. • The 13 principles of GCP set forth in ICH E6 are very encompassing and are in line with the guidelines used for domestic studies. • The principles of the Declaration are within GCP and form the basis for the ethical considerations in those guidelines. • The change from the Declaration to GCP would update the standards for the acceptance of foreign studies and help ensure the quality and integrity of data obtained from such studies. • Applying GCP standards to foreign studies not conducted under an IND brings logical symmetry with FDA regulation of studies conducted in the United States and ends the need to comply with the strict wording of the Declaration, which lacks the detail needed to describe usefully the intended compliance. • The proposal to rely on GCP is a more coherent approach to the multitude of complex issues that arise in overseas research than the Declaration provides. (Response) We agree with the comments stating that the requirement to conduct studies in accordance with GCP will ensure that these foreign studies will be conducted in a manner that is comparable to that required for domestic studies conducted under an IND. We also agree that the principles of the Declaration are reflected in the concept of GCP codified in § 312.120(a)(1)(i). We also agree with the comment that application of the GCP standard will protect human subjects while also enhancing the quality and integrity of data generated in these foreign studies. (Comment 2) One comment recommended that we give attention to the current development of international standards for the ethical review of clinical studies, including the work done by the Office for Human Research Protections
(OHRP)(of the U.S. Department of Health and Human Services), the European Forum for GCP, the World Health Organization (WHO), and the Strategic Initiative for Developing Capacity in Ethical Review. (Response) We agree that it is important for us to monitor the development of international standards for the ethical review of clinical studies. However, for purposes of determining whether data from non-IND foreign clinical studies can be used in support of an IND or application for marketing approval under § 312.120, we have concluded that it is appropriate to require that these studies be conducted in accordance with GCP for the reasons stated in section I of this document. Although the international standards noted by the comment are important, they are not legally binding on sponsors and applicants under § 312.120, and incorporating these standards into our regulations would present the same problems as codifying a reference to the Declaration, as explained in our response to comment 4 of this document. (Comment 3) Several comments opposed the proposal to delete the reference to the Declaration in § 312.120. Several comments stated that the Declaration represents the international standard or paradigm for the ethical conduct of clinical studies and the protection of human subjects. One comment stated that the Declaration is a living document that remains extremely influential and forms the substance of what people understand as the guiding principles of ethical research. (Response) As stated in the preamble to the proposed rule, we believe that our GCP standard will ensure adequate protection of human subjects while providing the flexibility necessary to accommodate differences in how countries regulate clinical research and obtain informed consent. We acknowledge the prominence of the Declaration among international standards on the treatment of human subjects in medical research, but other national and international ethical guidelines for research, such as the Belmont Report and guidelines issued by the Council for International Organizations of Medical Sciences, also are important. The U.S. Government continues to support the Declaration's underlying principles. However, as discussed in our response to comment 7 of this document, the U.S. Government does not fully support the 2000 version of the Declaration because it contains certain statements that may be inconsistent with U.S. law and policy (e.g., concerning use of placebos in clinical trials). We believe that the requirement to conduct non-IND foreign studies in accordance with GCP, which includes a requirement to protect the rights, safety, and well-being of subjects, ensures adequate protection of subjects without a need for reference to the Declaration. (Comment 4) Four comments stated that our statement in the proposed rule that the Declaration can be modified independent of FDA authority does not provide a basis for deleting the Declaration. These comments stated that we acknowledged that revisions to the Declaration could not supersede U.S. laws and regulations. These comments added that FDA declared in 2001 (in our guidance on “Acceptance of Foreign Clinical Studies”) that the reference to the Declaration in FDA regulations was to the 1989 version. One comment stated that the possibility that the 40-year-old Declaration might become inconsistent with U.S. ethics regulations is minimal. (Response) The comments appear to misunderstand our statements concerning the effect of modification of the Declaration. As we stated in the preamble to the proposed rule, the Declaration was not established under our authority and is subject to change independent of our control. We proposed to remove from the regulations the 1989 Declaration, which, because it was not the most recent version approved by the WMA, had the potential to cause confusion about the requirements for non-IND foreign clinical studies. The potential for confusion may increase with each subsequent revision of the Declaration. Moreover, initiating a rulemaking to revise § 312.120 each time the Declaration is changed would be burdensome and would not be possible if the changes were inconsistent with U.S. law and policy. For these reasons, the comments' statements regarding modification of the Declaration do not support retaining a reference to the Declaration in § 312.120. (Comment 5) One comment stated that eliminating the reference to the Declaration would damage international medical ethics and undermine the human rights approach and traditional foundations of research ethics in the Declaration, the Nuremberg Code, and the Universal Declaration of Human Rights. One comment stated that deleting the reference to the Declaration might send a message that FDA no longer supports high standards of ethics in research involving human subjects in foreign countries. One comment stated that the policy of unilaterally deciding not to rely on one of the most respected ethical documents is worrying. One comment stated that dismissing the relevance of the Declaration would encourage every other country to do the same. (Response) We disagree with these comments. We remain firmly committed to protecting the rights, safety, and well-being of subjects in both foreign and domestic research, and this commitment is reflected in § 312.120, our IND regulations, and our guidance documents, including ICH E6. We do not believe that deleting the reference to the Declaration in § 312.120 will damage international medical ethics or result in harm to research subjects because sponsors and applicants will need to comply with GCP, which includes protection of human subjects. It is also worth noting that the United States is not alone in declining to adopt the Declaration as the standard to apply. For example, the European Union
(EU)recognizes the importance of the Declaration, noting in Directive 2001/20/EC on the implementation of GCP in the conduct of clinical trials that the “accepted basis for the conduct of clinical trials * * * is founded in the protection of human rights and the dignity of the human being with regard to the application of biology and medicine, as for instance reflected in the 1996 version of the Helsinki Declaration.” Nevertheless, Directive 2001/20/EC does not incorporate the Declaration in the articles of the directive. Similarly, we do not believe that codification of the Declaration in our regulations is needed to ensure that foreign studies used to support U.S. drug applications are conducted in accordance with high ethical standards. (Comment 6) Several comments stated that they preferred the Declaration over GCP (as described in ICH E6) as a standard for ethical principles. Several comments stated that the Declaration is produced by the WMA, which is comprised of 82 national medical associations, whereas ICH documents are the product of the regulatory authorities and pharmaceutical industries of the United States, the EU, and Japan. One comment stated that the Declaration is independent of any one nation and represents a consensus, albeit sometimes uneasy, between many different parties with many diverse interests. One comment stated that the ethical principles in the 2000 Declaration were produced under an international and democratic process conducted by the WMA. One comment stated that it is improper for FDA to dismiss the views of the academicians, researchers, and clinicians who comprise the WMA and who have adopted the Declaration provisions. (Response) Although we appreciate the significance of the Declaration, we do not agree that the manner in which it was adopted makes it the most appropriate standard for the conduct of clinical studies. In fact, our regulations do not require that studies conducted in the United States under an IND be conducted in accordance with the Declaration. Furthermore, although we have not incorporated ICH E6 into our regulations (see comment 9 of this document), we disagree with the comment's characterization of the process for developing ICH guidelines. Twenty-seven countries (the United States, Japan, and the 25 member-states of the EU) participate in the ICH process, and Canada, Switzerland, and the WHO are observers. In addition to input from regulatory authorities and drug manufacturers, there is considerable opportunity for public health organizations, consumers, researchers, academicians, and others to comment publicly on proposed ICH guidelines, both before their adoption at the international level and before they are incorporated into the regulatory framework of individual ICH countries. Finally, by deleting the reference to the Declaration, we are not dismissing the views of WMA members regarding the protection of human subjects. Instead, we simply conclude that it is most appropriate and effective to ensure that studies are properly conducted by requiring compliance with GCP, as defined in § 312.120(a)(1)(i). (Comment 7) In objecting to the deletion of the reference to the Declaration, several comments cited the United States' objection to paragraphs 29 and 30 of the version of the Declaration adopted in 2000 (paragraphs 29 and 30). Paragraph 29 states: “The benefits, risks, burdens and effectiveness of a new method should be tested against those of the best current prophylactic, diagnostic, and therapeutic methods. This does not exclude the use of placebo, or no treatment, in studies where no proven prophylactic, diagnostic or therapeutic method exists.” Paragraph 30 states: “At the conclusion of the study, every patient entered into the study should be assured of access to the best proven prophylactic, diagnostic and therapeutic methods identified by the study.” Several comments were critical of the United States' objection to paragraphs 29 and 30 and expressed concern about its impact on research subjects. On the other hand, one comment expressed opposition to paragraphs 29 and 30. (Response) Compliance with the GCP standard will ensure adequate protection of human subjects in foreign clinical studies while accommodating differences in local authorities' regulation of these studies. As stated in our response to comment 3 of this document, we cannot endorse the 2000 version of the Declaration. We believe that paragraph 29 is inconsistent with U.S. law and policy because it would impose a standard for the design of clinical trials that is different from the standard of “adequate and well-controlled investigations,” which the act requires us to apply. Paragraph 30 invokes issues of health care policy that are not directly related to FDA's mission of ensuring that medical products are safe and effective. In addition, we do not believe that this rulemaking is the proper forum for debating or resolving issues concerning particular paragraphs of the Declaration, such as use of placebo controls or continued access to therapy after a study is concluded. (Comment 8) Several comments stated that deletion of the reference to the Declaration will have an adverse impact on the populations of developing countries, who are vulnerable to abuse, exploitation, and negligence because of their relative poverty and lack of education. One comment stated that the proposed rule is consistent with FDA's purported purpose of weakening items in the Declaration related to protection of human subjects in developing countries. One comment stated that deletion of the Declaration would imply that FDA believes that non-U.S. study populations do not need access to study results or that non-U.S. populations could be studied and put at risk only to identify medical products that would benefit the U.S. population. (Response) We do not agree that deleting the reference to the Declaration will have a negative impact on research subjects in developing countries or result in less protection for subjects in foreign studies. Human subject protection is essential to GCP as defined in revised § 312.120, which, among other things, requires the protection of the rights, safety, and well-being of trial subjects, and review and approval of studies by an IEC. We do not believe that referencing the Declaration in our regulations would provide additional protection to the populations of developing countries beyond the protections set forth in revised § 312.120. (Comment 9) Several comments stated that ICH E6 is concerned primarily with procedural and technical issues, not overarching ethical issues. One comment stated that GCP does not encompass the range of concerns about the protection of human subjects that is provided for in the Declaration. One comment stated that while the Declaration focuses on researchers' ethical conduct and the primacy of patient welfare, ICH E6 focuses on the relations between researchers and pharmaceutical sponsors. One comment stated that ICH E6 is designed to improve data quality but is unconcerned with ethics. (Response) We disagree with the comments. Most importantly, we note that the definition of GCP contained in § 312.120 is the standard that will apply to these studies, rather than the procedures set forth in ICH E6. The regulation requires, among other things, that the rights, safety, and well-being of subjects be protected, that an IEC review and approve (or provide a favorable opinion on) each study before initiation, and that subjects give informed consent. As for ICH E6 itself, protecting the interests of human subjects is one of its two fundamental purposes, along with helping to ensure the quality of data from clinical studies. The first paragraph of the introduction to ICH E6 states that compliance with GCP “provides public assurance that the rights, safety, and well-being of trial subjects are protected, consistent with the principles that have their origin in the Declaration of Helsinki, and that the clinical trial data are credible” (p. 6). In addition, the first principle of GCP listed in ICH E6 (section 2.1) is that “[c]linical trials should be conducted in accordance with the ethical principles that have their origin in the Declaration of Helsinki, and that are consistent with GCP and the applicable regulatory requirement(s)” (p. 8). Sections 3.1 and 4.3/4.8 of ICH E6 address the responsibilities of institutional review boards (IRBs)/IECs and investigators, respectively, concerning matters related to the care and treatment of research subjects, 2 including provisions on informed consent and medical care of subjects. Thus, although ICH E6 does address procedural issues, ethical issues are another principal focus of the document. 2 ICH E6 at pp. 10-11, 14-15, 17-21. (Comment 10) Several comments recommended that FDA simply add to the regulations a requirement to comply with GCP rather than delete the reference to the Declaration. One comment stated that it understood the need for data standardization and urged us to add GCP requirements without eliminating the reference to the Declaration. One comment stated that international studies, as they have been conducted in the past, can comply with both documents. Another comment stated that adherence to both documents would not cause the quality of these foreign studies to suffer. Several comments stated that the GCP guidance does not address conflict of interest or the need to publish results, which are both included in the Declaration. These comments stated that the two documents are complementary and that the regulations could require that affected studies comply with both documents. (Response) For the reasons stated previously in this document, it is no longer appropriate for § 312.120 to require compliance with the Declaration, either the 1989 version, the current
(2000)version, or some other future or past version. Moreover, we believe that because of the requirement in § 312.120 that acceptable foreign studies be conducted in accordance with GCP, which includes ensuring that the rights, safety, and well-being of trial subjects are protected, a specific reference to the Declaration will not enhance protection of human subjects. Nor do we believe that § 312.120 should address conflicts of interest or the need to publish study results. Other FDA regulations address conflicts of interest in these foreign studies (for example, the provisions on financial disclosure by clinical investigators in part 54 (21 CFR part 54) are applicable to studies submitted in support of an NDA, ANDA, or BLA under § 314.50(k), 21 CFR 314.94(a), and § 601.2(a), respectively). With respect to the publication of study results, we note that section 801 of the Food and Drug Administration Amendments Act of 2007 (42 U.S.C. 282(j)(3)) provides for publication in a results data bank of the results of “applicable clinical trials” under certain circumstances. In addition, we strongly encourage sponsors to seek publication in peer-reviewed journals. B. Definition of Independent Ethics Committee We proposed to add, under § 312.3, a definition for IEC. We proposed to define IEC to mean a review panel that is responsible for ensuring the protection of the rights, safety, and well-being of human subjects involved in a clinical investigation and is adequately constituted to provide assurance of that protection. An IRB, as defined in § 56.102(g) (21 CFR 56.102(g)) of this chapter and subject to the requirements of part 56 (21 CFR part 56), is one type of IEC. (Comment 11) Several comments stated that the proposed definition of IEC differed from the definition in ICH E6, and requested that we provide clarification of the term “adequately constituted” in the definition of IEC. One comment suggested either defining “adequately constituted” as “if its composition and membership complies with [part] 56, subpart B of this chapter,” or omitting “adequately constituted” from the definition of IEC, making it consistent with the definition in ICH E6. Other comments suggested defining IEC as in section 1.27 or 3.2 of ICH E6. (Response) The requirement in § 312.3 that the IEC be “adequately constituted” emphasizes the importance of the IEC having appropriate expertise to perform its critical role in the protection of human subjects. As described in the preamble to the proposed rule, we would consider an IEC to be adequately constituted if it “includes a reasonable number of members with the qualifications and experience to perform the IEC's functions (see, e.g., section 3.2.1 of the Good Clinical Practice guidance [ICH E6])” (69 FR 32467 at 32468). Such an “adequately constituted” IEC is responsible for ensuring the protection of the rights, safety, and well-being of human subjects involved in a clinical investigation. Although the definition of an IEC in ICH E6 does not include the term “adequately constituted,” ICH E6 defines an IEC as being “constituted of medical/scientific professionals and nonmedical/nonscientific members whose responsibility it is to ensure the protection of the rights, safety and well-being of human subjects” (section 1.27). We view our proposed definition of IEC as consistent with the definition of IEC in ICH E6 but at the level of specificity and detail appropriate for regulation. We recognize that the organization and membership of IECs may differ among countries because of the local needs of the host country, but we believe that such variation should not affect an IEC's ability to perform its functions. Our regulations must be sufficiently flexible to accommodate differences in how countries regulate the conduct of clinical research, including the composition of an IEC. Therefore, we will not specifically define IEC membership in the regulations or require that an IEC comply with the requirements in subpart B of part 56, or with the recommendations for membership in ICH E6. However, we would consider an IEC that is constituted to comply with part 56 or with ICH E6 to be “adequately constituted.” In fact, the definition of IEC in § 312.3 clarifies that an IRB, as defined in § 56.102(g) and subject to the requirements of part 56, is one type of IEC. For these reasons, we decline to omit “adequately constituted” from the definition of IEC in § 312.3. C. Local Laws and Regulations (Comment 12) Some comments stated that the proposed rule would delete the provision in former § 312.120(c)(1) requiring that foreign clinical research be conducted according to the laws and regulations of the country in which the research was conducted, when such laws provided for greater protection of human research subjects than the principles of the Declaration. Some comments stated that deleting the reference to compliance with local laws of the host country supported the notion that FDA could accept data collected in violation of those laws. (Response) We do not agree that deletion of this provision will lead to FDA accepting studies not conducted in accordance with local laws. Sponsors, IECs, investigators, and research sites and/or institutions are all responsible for complying with the local requirements for conducting research, including any requirements that may be more stringent than the requirements in § 312.120. A host country may deny a sponsor's request to conduct research in the country if the sponsor does not comply with local requirements, or may stop a study that is in progress in violation of the host country's laws. New § 312.120 sets forth U.S. standards for acceptance of foreign clinical studies in support of an IND or application for marketing approval, including that the study be conducted in accordance with GCP. We are confident that these standards provide for the protection of human subjects, and we will accept a study only if these standards are met. In addition, sponsors or applicants that currently conduct clinical trials in accordance with ICH E6 would comply with local requirements because ICH E6 states that one of the principles of GCP is that clinical trials be conducted consistent with the applicable regulatory requirements (i.e., any laws and regulations addressing the conduct of clinical trials of investigational products of the jurisdiction where a trial is conducted). (Comment 13) One comment stated that although proposed § 312.120 referenced general GCP standards, it did not clarify whether GCP as interpreted by the host country was at all relevant to acceptance of data or whether the ethics committee that must be used was one approved by the host country. (Response) The host country's interpretation of GCP is relevant to these non-IND foreign clinical studies because the host country requires the sponsor to comply with its laws. However, we will only accept data from studies that we determine were conducted in accordance with GCP as described in § 312.120(a)(1)(i). As to whether the IEC must be approved by the host country, if a host country requires by law that the host country approve the IEC, the sponsor would need to comply with that requirement. However, we will not specifically require in § 312.120 that an adequately constituted IEC be approved by the host country. We do not believe that such approval is essential to ensuring the quality of data or the protection of human subjects. Therefore, this matter is left to the discretion of the host country. (Comment 14) One comment recommended including a provision in § 312.120 to continue to allow a sponsor to document that the study was conducted in a country where the laws and regulations already provide for strict adherence to the principles of GCP, which would clearly provide for the assurance of protection of human research subjects and quality of clinical data. As support for this approach, the comment stated that clinical trials conducted in Europe must now meet the requirements of the EU Clinical Trials Directive and its implementing guidance for the conduct of clinical trials under GCP. (Response) We believe that the supporting documentation required under § 312.120(b), combined with an onsite inspection if necessary, will provide us with the ability to determine if a foreign clinical investigation was conducted in accordance with GCP. If the country adheres to the principles of GCP and the study complied with those principles, this should be reflected in the documentation submitted to us. Therefore, it is not necessary to add a provision as suggested by the comment. D. Acceptance of Studies (Comment 15) One comment stated that the proposed rule should be consistent with FDA's 1998 guidance “FDA Approval of New Cancer Treatment Uses for Marketed Drug and Biological Products” (New Cancer Treatment Guidance). The comment stated that section III.B of the New Cancer Treatment Guidance allows certain data to be submitted to us without additional data collection, auditing, or analyses by a pharmaceutical company submitting a marketing application, depending on the quality and credibility of the institutions providing such data. (Response) We do not agree that this rule and the New Cancer Treatment Guidance concern the same issues. Although the guidance addresses the submission of certain data without the applicant being subject to auditing, this is applicable only to data from studies conducted by independent cancer clinical trials organizations that have well-established and publicly available procedures for research data management, monitoring, and auditing, and a track record of high-quality research (e.g., U.S. National Cancer Institute-sponsored cooperative cancer research groups and other highly credible organizations that have no commercial interest in study outcomes). The guidance does not address the submission of foreign clinical data and is limited in scope to drugs for treating cancer. We will not accept foreign clinical studies in support of an IND or application for marketing approval except as set forth in § 312.120. (Comment 16) One comment recommended including the following statement in § 312.120 to reduce the potential regulatory burden: “The information to be provided in support of the IND does not need to be submitted to FDA throughout the study. The supporting information may be provided at the time the clinical study report is filed to the FDA in support of an NDA and/or made available upon request.” (Response) We do not agree that including such a statement in § 312.120 is necessary because the submission and reporting requirements are already clear. Information required under § 312.120 to be submitted in support of an IND or application for marketing approval would be submitted at the time the application is submitted to the agency. Once an application is pending before the agency, the applicable reporting requirements for INDs, NDAs, ANDAs, or BLAs under part 312, 314, or 601 (21 CFR parts 314 and 601), apply. E. Definition of Good Clinical Practice For the purposes of § 312.120, we proposed, in § 312.120(a)(1)(i), to define GCP as a standard for the design, conduct, performance, monitoring, auditing, recording, analysis, and reporting of clinical trials in a way that provides assurance that the data and reported results are credible and accurate and that the rights, safety, and well-being of trial subjects are protected. We also proposed to require that GCP include oversight by an IEC and obtaining informed consent of subjects. The final rule clarifies the limited circumstances in which GCP would not require informed consent. The proposed rule stated that GCP does not require informed consent in life-threatening situations when the IEC reviewing the study finds that the conditions present are consistent with those described in §§ 50.23 or 50.24(a) (21 CFR 50.23 or 50.24(a)), or when the measures described in the study protocol or elsewhere will protect the rights, safety, and well-being of subjects and ensure compliance with applicable regulatory requirements. We explained in the preamble that this provision would be consistent with the GCP guidance, which recommends that a legally authorized representative provide informed consent or that the requirement of informed consent be waived under such circumstances. In the final rule, we have made more explicit two conditions that were implicit in the proposed rule: The IEC review must occur before initiation of the study and the IEC must find that informed consent is not feasible. In addition, we deleted the provision referring to the IEC ensuring compliance with applicable regulatory requirements. Upon reconsideration, we recognized that the reference to “applicable regulatory requirements” was not clear. We had not described the requirements we considered to be applicable, and without additional clarity, the phrase did not provide additional protections for subjects in the study. Therefore, we decided that the provision would be clearer without this phrase. (Comment 17) Several comments requested confirmation that compliance with ICH E6 would be adequate to assure compliance with § 312.120 and questioned whether citing compliance with ICH E6, rather than submitting the supporting documentation required under 312.120(b), would be acceptable. One comment requested that we waive requirements in the proposed rule for any study conducted in EU member states, provided the member can submit a EudraCT (a database of clinical trials in the EU) number, and for any studies that have been conducted in Japan under Japanese Good Clinical Practices. One comment stated that the rule should explicitly require following ICH E6 because imposing a U.S. standard “consistent with” an international standard seemed insufficient. One comment recommended that if § 312.120 does not specifically require following ICH E6, we should acknowledge in the final rule or subsequent guidance that ICH E6 should be taken into account as one GCP standard that we find acceptable, and describe in what ways the standard set forth in § 312.120 differs from that in ICH E6. (Response) As noted in the preamble to the proposed rule, we have already incorporated many of the principles of GCP into our existing regulations. However, we have not specifically incorporated all of ICH E6 into our regulations, and we will not do so in § 312.120, for several reasons. First, for one of the same reasons that we deleted the reference to the Declaration from § 312.120, we do not believe that it is appropriate to reference in a regulation a document that is subject to change independent of our control. Second, although we adopted ICH E6 in 1997 for use as guidance for industry, there are other international documents that provide acceptable standards for GCP. Specific incorporation of ICH E6 into § 312.120 would constrain our ability to accept data from non-IND foreign clinical studies from countries that use other comparable GCP standards. Finally, ICH E6 contains a level of detail and specificity that is not appropriate for regulations. We believe that the GCP standard in § 312.120 is appropriate because it provides sufficient flexibility to accommodate differences in how countries regulate the conduct of clinical research, while still ensuring adequate and comparable human subject protection. Therefore, we do not require that sponsors or applicants follow ICH E6, but a study conducted in compliance with ICH E6 would meet the GCP requirements in § 312.120. However, for the agency to evaluate such a study, the information required under § 312.120(b) must be submitted. It would not be adequate to simply submit a statement that ICH E6 or Japanese GCP were followed, or to provide only a EudraCT number. F. IEC Review and Approval Proposed § 312.120(a)(1)(i) stated that GCP includes review and approval (or provision of a favorable opinion) by an IEC before initiating a study and continuing review of an ongoing study by an IEC. (Comment 18) One comment stated that the requirement for review and approval by an IEC does not guarantee protection of the participants unless the guidelines that the IEC must follow are stated explicitly and are not weaker than the Declaration. (Response) We disagree. Although § 312.120(a)(1)(i) requires review and approval of a clinical study before initiation, the regulation does not specify the procedures that the IEC must follow because different procedures offering equivalent human subject protection may be followed in different countries. As previously stated, we believe that the GCP standards in § 312.120, including the requirement for review and approval by an IEC, are and should be sufficiently flexible to accommodate differences in how countries regulate the conduct of clinical research, while ensuring adequate and comparable human subject protection. G. Onsite Inspection Proposed § 312.120(a)(1)(ii) would have required, as a condition of acceptance of a study submitted under this section, that we be able to validate the data from the study through an onsite inspection if we deem it necessary. (Comment 19) One comment recommended that we give attention to the current development of national and regional (e.g., European Medicines Agency) inspections outside the United States and the role they might play in providing public assurance for the quality of data and the protection of human subjects. (Response) Although this rule does not address the process for conducting inspections outside the United States, we can review and consider information from inspections by foreign authorities. However, if deemed necessary, we are also able, under § 312.120(a)(1)(ii), to conduct an onsite inspection to validate the data from a study. H. Data From Studies Not Conducted in Accordance With GCP Proposed § 312.120(a)(2) stated that although we will not accept as support for an IND , NDA, or BLA a study that does not meet the conditions of § 312.120(a)(i), we will examine data from such a study. (Comment 20) One comment requested that we clarify the meaning of proposed § 312.120(a)(2). The comment asked if this provision means that a sponsor should submit studies conducted on the investigational product but differentiate studies that comply for FDA review of safety and efficacy, or that we will review noncompliant studies as supportive. (Response) The provision states that we “will not accept as support” for an IND or application for marketing approval a study that does not meet the conditions of § 312.120(a)(1) (i.e., a “noncompliant” study). Nonetheless, a sponsor or applicant of an IND or application for marketing approval must submit all studies and other information required under applicable FDA regulations for drugs and biologics, including “noncompliant” studies. We would review information from “noncompliant” studies because they might have bearing on the safe use of the product. In the application, a sponsor or applicant should identify any studies that do not meet the conditions of § 312.120(a)(1). I. Supporting Information Proposed § 312.120(b) would have required a sponsor or applicant submitting a non-IND foreign clinical study in support of an IND, NDA, or BLA to submit, in addition to information required elsewhere in parts 312, 314, or 601, supporting information that describes the actions taken to ensure that the research conformed to GCP. 1. General Comments (Comment 21) Some comments stated that certain of the proposed requirements for submission of supporting information in § 312.120(b) are not entirely consistent with guidance provided in other relevant ICH documents. One comment requested that we confirm that conducting a study in accordance with ICH E6 and reporting and submitting the study according to ICH E3 (“Structure and Content of Clinical Study Reports”), ICH M4 (“Common Technical Document for the Registration of Pharmaceuticals for Human Use”), and FDA's corresponding guidance documents satisfies all the requirements of proposed § 312.120(b). In addition, the comment requested that in cases where the requirements in § 312.120(b) differed from ICH E3 and M4 standards, we consider modifying the requirements, thereby allowing sponsors to submit IND and non-IND studies according to a single standard. (Response) Conducting a study in accordance with ICH E6 and reporting and submitting the study according to ICH E3, ICH M4, and FDA's corresponding guidance documents would not satisfy all the requirements of § 312.120(b). The supporting documentation required in § 312.120(b) must describe the actions the sponsor or applicant took to ensure that the research conformed to GCP. This supporting documentation will supplement information required elsewhere in parts 312, 314, or 601. If any of the supporting information is already included in another section of the IND or application for marketing approval, the sponsor or applicant would not be required to submit this information more than once. We revised § 312.120(b) to clarify that, in submitting the description of the actions taken to ensure that research conformed to GCP, the sponsor or applicant is not required to duplicate information already submitted in the IND or application for marketing approval. Instead, the description submitted must provide either the supporting information required in § 312.120(b)(1) through (b)(11) or a cross-reference to another section of the submission where the information is located. In some cases, it would be necessary to supplement studies submitted according to ICH E3 and M4 with additional information to adequately describe the actions the sponsor or applicant took to ensure that research conformed to GCP. ICH E3 provides advice on structuring and reporting data from a clinical trial, and ICH M4 provides advice on the organization of information in an application. These documents, unlike ICH E6, were not developed to address GCP. 2. Investigator Qualifications and Description of Research Facilities Proposed § 312.120(b)(1) would have required submission of the investigator's qualifications, and proposed § 312.120(b)(2) would have required submission of a description of the research facilities. (Comment 22) One comment stated that we were imposing an additional regulatory burden by requiring a description of the investigator's qualifications and a description of the research facilities. The comment stated that the information provided should be similar to that currently provided to FDA by sponsors for studies conducted under an IND. (Response) We do not agree that the rule would impose any additional regulatory burden related to investigator's qualifications and description of research facilities. Section 312.120(b)(1) and (b)(2) of the final rule are unchanged from previous § 312.120(b)(1) and (b)(2), so there is no greater or lesser regulatory burden compared to what was previously required. In addition, we believe that assessment of the qualifications of the investigators and the adequacy of the research facilities are important factors in determining the reliability of the data generated by the study. IND sponsors are required to submit information about investigator qualifications and the name and address of the research facilities (whether domestic or foreign) to be used for each protocol (§ 312.23(a)(6)(iii)(b)). This rule does not require more information about investigator qualifications from sponsors of non-IND foreign studies. However, we generally are less likely to be familiar with the research facilities in which those studies are conducted. Therefore, we believe that it is appropriate to require a description of the research facilities for these studies to help us determine the adequacy of the facilities and to prioritize the need for an onsite inspection. 3. Detailed Summary of Protocol and Results of the Study Proposed § 312.120(b)(3) would have required submission of a detailed summary of the protocol and results of the study. In addition, the sponsor or applicant would have been required to submit case records maintained by the investigator or additional background data, such as hospital records or other institutional records, if requested by FDA. (Comment 23) One comment recommended that we modify the requirement in proposed § 312.120(b)(3) to allow sponsors to follow ICH E3, in which annex I, “Synopsis,” provides the template for the detailed summary of the protocol. (Response) We do not agree that submitting only the Synopsis from annex I of ICH E3 would be adequate to meet the requirements in § 312.120(b)(3) because the synopsis would not provide sufficient detail about the study protocol or results. Therefore, we have not modified the requirement as suggested by the comment. Although following ICH E3 is not required, an integrated, full clinical study report submitted in accordance with ICH E3 would be acceptable for meeting the requirements for providing summaries of the study protocol and results in § 312.120(b)(3). In addition, sponsors and applicants must submit information required elsewhere in parts 312, 314, or 601. (Comment 24) One comment indicated that the reference to “hospital records” in § 312.120(b)(3) suggests that we could request hospital records instead of a description of medical records maintained by an investigator, which might lead to data privacy concerns. One comment stated that the requirements for recordkeeping by investigators described in ICH E6, which it said were comparable to the requirements for investigator recordkeeping in § 312.62, should be included in the final rule. (Response) Proposed § 312.120(b)(3) was unchanged from previous § 312.120(b)(3). If we need source documents such as hospital records to verify data, these records must be available during an onsite inspection or provided upon request. If the necessary records are not available, we might not accept the study as support for an IND or application for marketing approval. We believe that informed consent documents should notify subjects that regulatory authorities will have direct access to the subject's original medical records for verification of clinical trial procedures and data, which is consistent with ICH E6, section 4.8.10(n). However, if a sponsor or applicant cannot disclose foreign records because it is prohibited by foreign law, the sponsor or applicant and FDA would need to agree upon an alternative validating procedure if the agency is to rely on the data. With respect to investigator recordkeeping, this rule does not address individual investigator responsibilities, but rather describes the requirements for sponsors or applicants who are submitting non-IND foreign clinical studies in support of an IND or application for marketing approval. Sponsors or applicants are responsible for ensuring that their investigators meet their responsibilities. As originally proposed, the retention requirements in § 312.57(c) for records and reports required under part 312 would have applied to records required under this rule. However, we decided to clarify the record retention requirements applicable to records required under this rule and incorporate the provision directly into § 312.120. Accordingly, we have added the following provision at § 312.120(d): A sponsor or applicant must retain the records required by this section for a foreign clinical study not conducted under an IND as follows:
(1)If the study is submitted in support of an application for marketing approval, retain records for 2 years after an agency decision on that application;
(2)if the study is submitted in support of an IND but not an application for marketing approval, retain records for 2 years after the submission of the IND. This record retention provision is similar to the requirements set forth in § 312.57(c). 4. Names and Qualifications of IEC Members Proposed § 312.120(b)(6) would have required submission of the names and qualifications for the members of the IEC that reviewed the study. (Comment 25) One comment stated that although the requirement to provide names and qualifications of IEC members is in current § 312.120(c)(3), the regulation should allow for situations where it is impossible for a sponsor or clinical investigator to obtain this information. One comment stated that because of privacy concerns, some IECs only provide sponsors with letters to confirm that the constitution of the IEC is in agreement with GCP. The comment stated that ICH E6 requires that the investigator files include the IEC composition to document that the IEC is so constituted, and that this information is available in sponsor files. The comment recommended that as an alternative we consider requiring the name and address of each IEC that approved a study. One comment requested allowing a statement from the IEC that it is properly constituted within the applicable laws that they must follow. Another comment suggested that we change the requirement to “information on the composition (preferably names and qualifications, but at a minimum qualifications) of the IEC that reviewed the study to ensure that the IEC is duly constituted.” Another comment recommended that we only require a statement from the IEC that it is organized and operates according to ICH E6 and the applicable laws and regulations, which the comment stated was consistent with ICH E6, section 5.11.1(b). Two comments stated that the proposed requirement deviated from ICH E3, which includes a list of IECs or IRBs (plus the name of the committee chair, if required by the regulatory authority). The comments recommended that the requirement be revised to be consistent with ICH E3. (Response) Because oversight by an adequately constituted IEC is an essential component of human subject protection, it is critical that there be adequate documentation of the IEC composition. We believe that submission of the names and qualifications of the members of the IEC that reviewed the study, as proposed, is one way to document the adequacy of the committee. Nevertheless, in response to concerns raised by some of the comments, we have developed an alternative approach that provides comparable assurance. As revised, § 312.120(b)(6) requires submission of the name and address of the IEC that reviewed the study and a statement that the IEC meets the definition of IEC in § 312.3. Section 312.120(b)(6) also states that the sponsor or applicant must maintain records supporting the statement, including records of the names and qualifications of IEC members, and make these records available for agency review upon request. We specify that the retained records must include records of the names and qualifications of IEC members because we do not believe it is possible to verify that an IEC is adequately constituted without knowing about the IEC members. Because sponsors or applicants were already required under previous § 312.120(c)(3) to submit the names and qualifications of IEC members, this change lessens the burden on sponsors and applicants. In addition, sponsors or applicants who comply with ICH E6 would also obtain and retain records on the information required in § 312.120(b)(6) (see sections 3.4 and 5.5.11 of ICH E6). (Comment 26) One comment recommended that we clarify the type of information that must be provided to document the qualifications of the IEC because it will be difficult to assess meaningfully the true qualifications of IEC members simply by review of their formal professional qualifications. One comment recommended that FDA clarify that “qualifications” means not only formal academic certifications but also evidence that the members of the IEC, individually and as a group, are competent to protect clinical trial participants and ensure that the study is conducted in compliance with GCP. The comment suggested that the sponsor be required to provide evidence that the IEC members received training in bioethics and the principles of GCP or provide evidence that the IEC was accredited. (Response) We believe that submitting a statement that the IEC meets the definition in § 312.3 and maintaining the records specified in § 312.120(b)(6) will provide sufficient documentation that the committee is adequately constituted to provide assurance that the rights, safety, and well-being of human subjects are protected. We believe that it is appropriate to allow flexibility in the composition and training of the IEC. If we deem it necessary in a particular case, we will inspect the sponsor's or applicant's records. Therefore, we will not require sponsors and applicants to provide evidence of training or IEC accreditation. 5. Summary of the IEC's Decision Proposed § 312.120(b)(7) would have required submission of a summary of the IEC's decision to approve or modify and approve the study, or to provide a favorable opinion. (Comment 27) One comment requested clarification of the requirement to provide “a summary of the IEC's decision to approve or modify and approve the study, or to provide a favorable opinion.” The comment asked if it would be acceptable to provide a general statement that the IEC approved the study protocol prior to its conduct, noting any modifications required by the IEC (along with such items as amendments and consent forms). One comment recommended that IEC review and approval should continue to be documented by receipt of the approval letter from the committee. The comment stated that these letters are usually issued in the local language of the country in which the study is conducted and official translations could be provided. If approval letters are acceptable, the comment requested clarification on whether we would expect approval letters for only the original protocol or for all protocol amendments as well. One comment recommended that the requirement under § 312.120(b)(7) also account for documenting continuing review by the IEC under § 312.120(a)(1)(i). (Response) We agree that it would be sufficient to provide a brief summary of the IEC's actions to approve or modify and approve the study, prior to the initiation of the study. For example, it would be acceptable to provide the name of the IEC and a list of IEC actions and dates (e.g., initial approval date, date of approval of modification to study (if any)). Alternatively, it would be acceptable to provide approval letter(s) from the IEC, including those for protocol amendments. Although continuing review by the IEC is required under § 312.120(a)(1)(i), documentation of such review does not need to be submitted under § 312.120(b)(7). 6. Description of Informed Consent Process Proposed § 312.120(b)(8) would have required submission of a description of how informed consent was obtained. (Comment 28) Two comments recommended that we modify the requirement in § 312.120(b)(8) so that it is acceptable to follow ICH E3, section 5.3, which calls for a description of how and when consent was obtained (the representative written information for the research subject (if any), and the sample informed consent are provided in accordance with appendix 16.1.3). One comment stated that the proposed rule requests more stringent supporting information on how informed consent was obtained than what is currently required in part 314 for studies conducted under an IND and submitted in an NDA. (Response) We do not believe it is necessary to modify the requirement as suggested. The requirement to provide a description of how informed consent was obtained allows for flexibility regarding the manner in which this information can be submitted. For example, ICH E6, section 4.8, provides standards for the informed consent process, including who obtains informed consent, as well as how and when it should be obtained. Submitting documentation of this process would be acceptable to meet the requirement in § 312.120(b)(8). Likewise, it would be acceptable for sponsors or applicants to follow the relevant provisions in ICH E3 to meet the requirements. We do not agree that § 312.120(b)(8) is more stringent than the corresponding requirements in part 314 for studies conducted under an IND. Sponsors conducting studies under an IND would have to meet the requirements in parts 50, 56, and 312, which include detailed requirements for obtaining informed consent. 7. Description of Incentives to Subjects Proposed § 312.120(b)(9) would have required submission of a description of what incentives, if any, were provided to subjects to participate in the study. (Comment 29) Two comments recommended that we clarify the requirements of § 312.120(b)(9). One comment stated that it should be acceptable to provide a general statement in the protocol, study report, and sample consent that subjects were reimbursed for their time and travel costs or that subjects were paid for participation. Two comments stated that it should be adequate to follow ICH E3 (appendix 16.1.3), which includes providing a sample or model informed consent form, since it would describe any incentives. (Response) We believe that there should be some flexibility in how sponsors or applicants comply with § 312.120(b)(9). If the sponsor or applicant follows ICH E6, informed consent would include an explanation of any incentives provided to subjects (section 4.8.10), so a sponsor or applicant could submit a model consent form to meet § 312.120(b)(9). Alternatively, we agree that following ICH E3 and providing a sample or model informed consent form that describes any incentives provided, as specified in appendix 16.1.3 of ICH E3, would be sufficient to satisfy § 312.120(b)(9). A sponsor or applicant could also satisfy § 312.120(b)(9) by submitting a brief description of any incentives provided to subjects to participate in the study. 8. Description of Study Monitoring Proposed § 312.120(b)(10) would have required submission of a description of how the sponsor monitored the study and ensured that the study was carried out consistent with the study protocol. (Comment 30) Two comments asked that we modify the requirements to state that it is acceptable to follow ICH E3, section 9.6, Data Quality Assurance, which would mean providing a description of any steps taken at the investigational sites or centrally to ensure the use of standard terminology and the collection of accurate, consistent, complete, and reliable data; steps might include training sessions, monitoring of investigators, use of centralized testing, and data audits. One comment recommended that the proposed rule be revised to allow the submission of a general description of what activities were used to ensure the quality of data (e.g., monitoring, investigator training), in keeping with part 314. (Response) As with the other requirements for submission of supporting information, we believe that there should be some flexibility in how sponsors or applicants meet the requirements in § 312.120(b)(10). We agree that following ICH E3, section 9.6, would be acceptable to meet these requirements. Alternatively, sponsors or applicants could provide a description of how the study was monitored as specified in ICH E6, section 5.18. Although it is acceptable to follow these sections of ICH E3 or E6 to comply with § 312.120(b)(10), we will not require that they be followed, and a sponsor or applicant might use an alternative approach to comply with this provision. 9. Description of Investigator Training and Signed Written Commitments Proposed § 312.120(b)(11) would have required submission of a description of how investigators were trained to comply with GCP and to conduct the study in accordance with the study protocol. In addition, the sponsor or applicant would have been required to submit copies of written commitments, if any, by investigators to comply with GCP and the protocol. (Comment 31) Some comments requested that we clarify the requirements in § 312.120(b)(11). One comment asked if submission of a general statement in the study report that investigators were trained at an investigators meeting and/or during site initiation visits would be acceptable. Two comments stated that investigator training was included in ICH E3, section 9.6, and recommended that we modify the requirement so that it is acceptable to reference this section of the clinical study report. (Response) We agree that submitting a statement in accordance with ICH E3, section 9.6 (i.e., whether investigator meetings or other steps were taken to prepare investigators and standardize performance), would be an acceptable means of complying with § 312.120(b)(11), provided that the description included how investigators were trained to comply with GCP and to conduct the study in accordance with the study protocol. As previously stated with respect to other supporting documentation requirements, a sponsor or applicant might use an alternative approach to meet this requirement. (Comment 32) Several comments recommended that we eliminate the proposed requirement to submit copies of written commitments, if any, by investigators to comply with GCP and the protocol. Three comments stated that written investigator commitments are usually included on the investigator signature page of the study protocol. Under ICH E3, appendix 16.1.1, a blank copy of this page is provided with the protocol. In addition, ICH E6, section 8.2.2, advises sponsors to archive individual investigators' signature pages in the sponsor's trial master file. The comments stated that to comply with this part of § 312.120(b)(11), it should suffice to submit a description of how the investigator commitment to comply with GCP and the protocol was obtained, and we should eliminate the proposed requirement to submit an individual form for each participating investigator. Two comments requested that the proposed rule be revised to require that the signed investigator agreements be available in the sponsor's files, to be provided to us upon request. One comment stated that there is no need to submit an individual form for each investigator because this information has already been obtained by the sponsor. One comment recommended that we require sponsors to obtain written commitments from investigators to comply with GCP and the study protocol. (Response) We agree that submitting individual copies of signed investigator agreements is unnecessary. We recognize that, for those sponsors following ICH E3 and E6, these documents would be either submitted with the clinical study report or kept on file with the sponsor. We believe that it would be acceptable to submit a statement indicating whether written commitments by investigators to comply with GCP and the protocol were obtained and, if so, to maintain such commitments on file to be provided upon the agency's request. Therefore, we revised § 312.120(b)(11) to require submission of such a statement instead of copies of signed investigator commitments. We believe that evaluation of the statements regarding commitments, combined with the availability of the signed commitments (if any) for our inspection, provides adequate assurance that investigators received GCP training and minimizes the burden on sponsors and the agency. We disagree with the comment that recommended requiring signed investigator commitments. Although we encourage sponsors to obtain written commitments, such commitments may not be required in all countries, and we do not want to preclude submission of ethically conducted foreign clinical studies solely because a written commitment was not obtained. J. Waivers Proposed § 312.120(c) would have permitted sponsors or applicants to request that FDA waive any applicable requirements under § 312.120(a)(1) and (b). Under proposed § 312.120(c)(2), we could have granted a waiver if we found that doing so would be in the interest of the public health. (Comment 33) One comment stated that proposed § 312.120(c)(2) could be construed as placing the interest of public health ahead of the need to protect trial participants in foreign countries. The comment recommended that we clarify the provision to indicate that a waiver would not be granted if this would compromise the sponsor's obligation to show that trial participants had been protected at all times, even though the waiver might be in the interest of public health. (Response) In providing for this waiver, we are giving the agency a measure of discretion to avoid inappropriate results. We envision that we might use this provision to allow us to accept a non-IND foreign clinical study conducted before the effective date of this rule, if the study is in compliance with the provisions of § 312.120 prevailing at the time it was conducted, but out of technical compliance with the terms of this rule. Section 312.120(c)(2) allows us to decide whether to grant or deny waivers on a case-by-case basis, taking into account all appropriate circumstances. IV. Implementation The proposed effective date would have applied the rule, when final, to foreign clinical studies for which the first subject is enrolled 180 days after the date of publication of the final rule. As proposed, a clinical trial that is currently ongoing, which might not be completed and for which the results might not be submitted to FDA (in an IND or application for marketing approval) for several years, would be submitted under previous § 312.120. We have determined that it is appropriate to make the rule effective 180 days after the date of publication in the **Federal Register** and applicable to foreign clinical studies regardless of the status of subject enrollment (e.g., ongoing, completed, not yet initiated). We have made this change to decrease the potential for confusion about which version of § 312.120 (new or previous) is applicable to ongoing clinical studies. We do not believe that this change will affect the ability of most sponsors or applicants to comply with § 312.120 because most foreign clinical trials are currently being conducted in accordance with GCP principles. If necessary, we can use the waiver provision under § 312.120(c) to accept studies initiated before the effective date of the rule if doing so would be in the interest of the public health. V. Legal Authority We are issuing this rule under the authority of the provisions of the act that apply to drugs (section 201 *et seq.* (21 U.S.C. 321 *et seq.* )) and section 351 of the PHS Act. These laws authorize the agency 3 to issue regulations to ensure the following:
(1)Data that we review are of adequate quality to enable us to make appropriate regulatory decisions;
(2)clinical investigators involved in developing data submitted to us are qualified to conduct such clinical investigations and are otherwise reliable; and
(3)clinical investigations generating data submitted in support of applications are well designed and well conducted in a manner supporting the reliability of study results. 3 In light of section 903(d) of the act (21 U.S.C. 393(d)) and the Secretary of Health and Human Services' (the Secretary's) delegations to the Commissioner of Food and Drugs, statutory references to “the Secretary” in the discussion of legal authority have been changed to “FDA” or the “agency.” Section 505 of the act requires us to weigh evidence of effectiveness and safety to determine whether the evidence supports drug approval, whether data are adequate to permit a clinical investigation to proceed under the IND regulations, and/or whether a product is appropriately labeled, and to weigh evidence of bioequivalence for generic drug approvals. Section 505(d) of the act provides that we may approve an NDA only after finding substantial evidence “consisting of adequate and well-controlled investigations, including clinical investigations, by experts qualified by scientific training and experience to evaluate the effectiveness of the drug involved, on the basis of which it could fairly and responsibly be concluded by such experts that the drug will have the effect it purports or is represented to have under the conditions of use prescribed, recommended, or suggested in the labeling or proposed labeling thereof.” When we review INDs, section 505(i) of the act requires us to determine whether the reports submitted in support of an application are “adequate to justify the proposed clinical testing” and whether the sponsor has submitted “adequate reports of basic information * * * necessary to assess the safety of the drug for use in clinical investigation.” The act also requires us to determine whether adequate and reliable studies are sufficient to support a drug's labeling. Under section 505(d)(5), evidence from clinical investigations of a drug's safety and effectiveness must support the conditions of use prescribed, recommended, or suggested in the labeling thereof. Section 505(j)(2)(A)(iv) of the act further requires us to assess information submitted in an ANDA demonstrating, among other things, that the ANDA drug is either bioequivalent to an already approved new drug which is the subject of an approved NDA, or can be expected to have the same therapeutic effect as such a drug, as determined by a petition submitted under section 505(j)(2)(C) of the act. Section 701(a) of the act (21 U.S.C. 371(a)) authorizes the agency to issue regulations for the efficient enforcement of the act. Section 351(a)(2)(C)(i)(I) of the PHS Act authorizes the agency to approve a BLA only if the applicant demonstrates that the product is safe, pure, and potent. Section 351(a)(2)(A) of the PHS Act authorizes the agency to establish, by regulation, requirements for the approval, suspension, and revocation of biologics licenses. These statutory provisions authorize us to issue regulations describing when we may consider foreign clinical studies not conducted under the IND regulations as reliable evidence supporting an IND or application for marketing approval. VI. Paperwork Reduction Act of 1995 This final rule contains information collection requirements that are subject to review by the Office of Management and Budget
(OMB)under the Paperwork Reduction Act of 1995 (the PRA) (44 U.S.C. 3501-3520). The title, description, and respondent description of the information collection provisions are shown in the following paragraphs with an estimate of the annual reporting and recordkeeping burden. The estimate includes the time for reviewing instructions, searching existing data sources, gathering and maintaining the data needed, and completing and reviewing each collection of information. *Title* : Foreign Clinical Studies Not Conducted Under an IND *Description* : Previous § 312.120 stated that we generally accept foreign clinical studies not conducted under an IND provided they are well designed, well conducted, performed by qualified investigators, and conducted in accordance with ethical principles. It further stated that such studies must be conducted in accordance with the 1989 Declaration or the laws of the country in which the research is conducted, whichever provides greater protection to subjects. The final rule replaces the requirement that non-IND foreign studies be conducted in accordance with the 1989 Declaration with a requirement to conduct such studies in accordance with GCP, including review and approval by an IEC. We are making this change for the following reasons:
(1)We want to provide greater assurance of the quality of data obtained from non-IND foreign studies;
(2)standards for protecting human subjects have evolved considerably over the past decade and include the adoption of GCP; and
(3)we want to eliminate the reference to the Declaration because that document is subject to change, independent of FDA authority, in a manner that might be inconsistent with U.S. laws and regulations, and referring to a superseded version of the Declaration could create the potential for confusion about the requirements for non-IND foreign studies. Under revised § 312.120(a), we will accept as support for an IND or application for marketing approval a well-designed and well-conducted foreign clinical study not conducted under an IND if the study is conducted in accordance with GCP and we are able to validate the data from the study through an onsite inspection if necessary. GCP includes review and approval by an IEC before initiating a study, continuing review of an ongoing study by an IEC, and obtaining and documenting the freely given informed consent of the subject before initiating a study. Previous § 312.120(b) required a sponsor of a non-IND foreign study who wanted to rely on that study as support for an IND or application for marketing approval to provide certain data to FDA. Revised § 312.120(b) requires this same information as well as the following:
(1)The name and address of the IEC and a summary of its decision to approve, or modify and approve, the study;
(2)a description of how informed consent was obtained and what incentives, if any, were provided to subjects to participate in the study;
(3)a description of how the sponsor monitored the trial and ensured that it was carried out consistently with the study protocol; and
(4)a description of how investigators were trained to comply with GCP and to conduct the trial in accordance with the protocol, as well as a statement on whether written commitments by investigators to comply with GCP and the protocol were obtained. Revised § 312.120(c) specifies how sponsors or applicants can request a waiver for any of the requirements under § 312.120(a)(1) and (b). By permitting a waiver of certain requirements, this provision is not likely to increase the burden on a sponsor or applicant. Under revised § 312.120(c)(1), a waiver request must contain at least one of the following:
(1)An explanation why the sponsor's or applicant's compliance with the requirement is unnecessary or cannot be achieved;
(2)a description of an alternative submission or course of action that satisfies the purpose of the requirement; or
(3)other information justifying a waiver. Under revised § 312.120(c)(2), FDA may grant a waiver if doing so would be in the interest of the public health. *Description of Respondents* : Businesses. *Burden Estimate* : Table 1 of this document provides an estimate of the annual reporting burden associated with the rule: **Table 1.—Estimated Annual Reporting Burden** 1 21 CFR Section No. of Respondents Frequency of Responses Total Annual Responses Hours per Response Total Hours 312.120 115 5 575 32 18,400 Total 18,400 1 There are no capital costs or operating and maintenance costs associated with this collection of information. We estimate that, each year, 115 companies submit a total of approximately 575 non-IND foreign clinical studies in support of an IND or application for marketing approval for a drug or biological product. We conducted consultations with seven large and small companies that had submitted non-IND foreign clinical studies to us during 1998 through 2001. All respondents indicated that they currently conduct non-IND foreign clinical studies in conformance with GCP and generally document all the items listed in revised § 312.120(b). Sponsors often plan to obtain marketing approval in more than one country and often conduct studies with the intention to submit data for review in multiple countries that may require compliance with GCP. Companies previously were required (under previous § 312.120(b)(1) through (b)(5) and (c)(3)) to document the items in revised § 312.120(b)(1) through (b)(7) as well as to document how the research conformed to the ethical principles contained in the 1989 Declaration or the foreign country's standards, whichever represented the greater protection of the individual (previous § 312.120(c)(2)). Hour burden estimates will vary due to differences in size, complexity, and duration across studies, because each of these factors affects the amount and intricacy of data collected. For example, the applicant of a study that involves five research sites, each with its own IEC, must submit documentation of review by all five committees. However, if the same study is performed with one IEC overseeing all five sites, the hour burden estimate would be less. As previously stated in this document, the general position among the sponsors that we interviewed was that documenting their compliance with GCP would take between 18 and 32 hours annually for each non-IND foreign clinical trial. To provide a liberal estimate of costs to industry, we assumed that no companies currently document compliance with any component of GCP and that the documentation required under revised § 312.120(b) would require 32 hours to complete for each study submitted for a total of 18,400 annual burden hours (575 x 32 hours). In addition to the reporting requirements set forth in table 1 of this document, the final rule includes a provision, § 312.120(d), stating how long sponsors and applicants must retain records required by § 312.120. Under the proposed rule, the retention requirements in § 312.57(c), for records and reports required under part 312, would have applied to these records. However, we decided to clarify the recordkeeping requirements applicable to records required under this rule by establishing § 312.120(d). Under § 312.120(d), if a study is submitted in support of an application for marketing approval, records must be retained for 2 years after an agency decision on that application; if a study is submitted in support of an IND but not an application for marketing approval, records must be retained for 2 years after the submission of the IND. The recordkeeping requirements for studies under part 312 are approved under OMB control number 0910-0014 until May 31, 2009. In compliance with the PRA (44 U.S.C. 3507(d)), we submitted a copy of this rule to OMB for its review and approval of these information collections. The reporting requirements of this final rule have been approved under OMB control number 0910-0622. This approval expires on April 11, 2011. An agency may not conduct or sponsor, and a person is not required to respond to, a collection of information unless the information collection displays a currently valid OMB control number. VII. Environmental Impact We have determined under 21 CFR 25.30(h) that this action is of a type that does not individually or cumulatively have a significant effect on the human environment. Therefore, neither an environmental assessment nor an environmental impact statement is required. VIII. Federalism We have analyzed this final rule in accordance with the principles set forth in Executive Order 13132. We have determined that the rule does not contain policies that have substantial direct effects on the States, on the relationship between the National Government and the States, or on the distribution of power and responsibilities among the various levels of government. Accordingly, we have concluded that the final rule does not contain policies that have federalism implications as defined in the Executive order and, consequently, a federalism summary impact statement is not required. IX. Analysis of Economic Impacts We have examined the impacts of the final rule under Executive Order 12866 and the Regulatory Flexibility Act (5 U.S.C. 601-612), and the Unfunded Mandates Reform Act of 1995 (Public Law 104-4). Executive Order 12866 directs agencies to assess all costs and benefits of available regulatory alternatives and, when regulation is necessary, to select regulatory approaches that maximize net benefits (including potential economic, environmental, public health and safety, and other advantages; distributive impacts; and equity). We believe that this final rule is not an economically significant regulatory action under the Executive order. The Regulatory Flexibility Act requires agencies to analyze regulatory options that would minimize any significant impact of the rule on small entities. Because the estimated impact of the final rule is not substantial and, in any event, clinical investigators generally follow GCP already, we certify that the final rule will not have a significant economic impact on a substantial number of small entities. Section 202(a) of the Unfunded Mandates Reform Act requires that agencies prepare a written statement, which includes an assessment of anticipated costs and benefits, before proposing “any rule that includes any Federal mandate that may result in the expenditure by State, local, and tribal governments, in the aggregate, or by the private sector, of $100,000,000 or more (adjusted annually for inflation) in any one year.” The current threshold after adjustment for inflation is approximately $127 million, using the most current
(2006)Implicit Price Deflator for the Gross Domestic Product. We do not expect this final rule to result in any 1-year expenditure that would meet or exceed this amount. A. Objectives of the Final Rule The objectives of the final rule are to ensure the quality and integrity of foreign clinical data supporting FDA decisionmaking on product applications and to help ensure the protection of human subjects participating in foreign clinical studies. High-quality data from foreign studies may be critical to our decisionmaking on applications and product labeling. By increasing our knowledge of a drug, including its effect in more diverse study populations, such data will help us better perform these review functions. By incorporating the monitoring and reporting responsibilities under GCP, the final rule also will reduce the risk to subjects who take part in foreign clinical trials of investigational drug and biological products. Most investigations of new therapeutic products carry potential risks for trial subjects due to the investigational nature of the products. However, if trials are well designed and carefully monitored, these risks can be minimized. B. Background on Current Situation Regarding Foreign Studies The current process for marketing a new drug product or amending the conditions of use of an existing product requires us to review and approve the results of clinical investigations included in applications for marketing approval. These applications contain the results of clinical investigations that characterize the therapeutic benefit of the new product and assess its risks. We review the submitted data and decide whether there is sufficient evidence of safety and effectiveness to grant approval. Clinical data included in an application for marketing approval usually are collected under an IND, for which protocols of the proposed clinical investigations are submitted for review. An IND is needed to lawfully administer an unapproved pharmaceutical or biological product to humans in the United States. However, not all clinical trials used to support an application for marketing approval take place in the United States. For a variety of reasons (e.g., foreign developer or manufacturer), there has been an increase in the number of foreign clinical investigations of potential new drug products. According to an analysis by the Department of Health and Human Services' Office of the Inspector General
(OIG)(Ref. 1), the number of foreign clinical investigators that conducted drug research under INDs increased from 41 in 1980 to 271 in 1990 and 4,458 in 1999. Although trials not conducted in the United States are not required to be conducted under an IND, many sponsors submit an IND before initiating a foreign trial. However, we have always required and reviewed the safety results of non-IND foreign clinical trials of drug products considered for marketing approval in the United States. According to estimates from the Center for Drug Evaluation and Research
(CDER)and the Center for Biologics Evaluation and Research (CBER), approximately 650 clinical investigations of investigational products intended for commercial marketing were initiated each year from 1995 through 1999. In addition, commercial sponsors submitted approximately 2,600 new protocols each year for new clinical trials under existing INDs. Therefore, in a typical recent year, we received approximately 3,250 new investigations (initial INDs and new protocols combined) for commercial development of new therapies. A CDER study of the INDs submitted to support development of new molecular entities
(NMEs)approved between 1995 and 1999 found that up to 35 percent of the trials that were conducted under an IND included foreign sites. Thus, in an average year, we estimate that approximately 1,140 foreign clinical trials (3,250 x 0.35) are conducted under IND review and oversight. However, this estimate does not include foreign clinical trials that were not subject to IND review. The CDER analysis indicates that as many as 15 percent of the trials submitted in NME marketing applications were not conducted under an IND. If this proportion holds with respect to all clinical trials, we estimate that approximately 3,825 clinical trials are conducted annually to develop data for submission to FDA in support of an application for marketing approval (assuming the 3,250 clinical trials conducted annually under an IND constitute only 85 percent of all trials conducted to develop data for such an application). We can then estimate that 575 non-IND foreign trials are conducted annually for eventual submission to FDA as part of an IND or application for marketing approval (3,825 - 3,250 = 575). We also estimated the number of applications supported by data from foreign trials not conducted under an IND. According to CDER data, each application for marketing approval may cite an average of approximately five investigations that provide important information relative to approval decisions. Lacking data on INDs supported by data from non-IND foreign trials, we will assume the same ratio of investigations to applications is true. Based on these estimates, we estimate that the 575 foreign trials conducted annually are used to support 115 INDs or applications for marketing approval. C. The Final Rule Under the final rule, all non-IND foreign clinical studies submitted as support for an IND or application for marketing approval must be conducted under GCP as defined in the rule. Under previous § 312.120, we accepted as support for an IND or application for marketing approval foreign clinical studies not conducted under an IND provided they were well designed, well conducted, performed by qualified investigators, and conducted in accordance with ethical principles. Sponsors of non-IND investigations used in support of INDs or applications for marketing approval were required to follow either the principles of the 1989 Declaration for patient protection or national laws that provide even greater protection. The final rule is expected to provide greater assurance that such clinical investigations will provide results that are of satisfactory quality while ensuring that the investigations are conducted with subjects' informed consent and do not place subjects unduly at risk. We believe that this change is necessary to ensure that foreign clinical investigations that are intended to be used as support for an IND or U.S. application for marketing approval are well designed and well conducted and provide sufficient protection to subjects. Consequently, under the final rule, we will not accept any non-IND foreign clinical results as support for sponsor claims of efficacy unless the trials are conducted in conformance with GCP. The results of all clinical trials must in any case be submitted with new product applications to evaluate the safety of the new therapy. D. Costs of the Final Rule We interviewed seven pharmaceutical manufacturers that had submitted results from non-IND foreign clinical studies to us during 1998 through 2001. These firms indicated that they currently conduct all research, including investigations not conducted under an IND, in accordance with ICH standards for GCP. However, the final rule requires that an applicant submit a description of the actions taken to ensure that the research conformed to GCP. Several items included in GCP (as defined in the final rule) are not specifically required to be documented and submitted in an application for marketing approval for results to be accepted by FDA. In particular, documentation that includes attestations by investigators and evidence that study protocols have been reviewed and approved by an IEC is not always included in INDs and applications for marketing approval. For studies under an IND, there are specific regulatory requirements for obtaining informed consent, ensuring IRB review, and carrying out appropriate monitoring. The absence of these requirements for non-IND studies makes it difficult for us to determine the adequacy of pre-initiation review of study protocols. The final rule will help ensure that these documents are available for our inspection at research sites and that information on IEC review is included in INDs and applications for marketing approval. The amount and detail of the necessary documentation will vary according to the size and complexity of the proposed clinical trial. The general position among the seven sponsors we interviewed was that providing a description of their compliance with GCP, including related documentation and recordkeeping, would take between 18 and 32 additional hours for each non-IND clinical trial. We obtained information on typical nonproduction, salaried labor costs for the pharmaceutical industry from the Bureau of Labor Statistics (North American Industrial Classification System (NAICS) 325412). Including wages and benefits, the average cost for these labor resources is slightly more than $30 per hour. As noted previously in this document, we estimate that approximately 575 non-IND foreign commercial clinical trials are conducted annually. Using the high estimate of the additional hours of documentation needed for each non-IND clinical trial, this would result in a total annual cost of about $552,000 to the sponsoring firms (32 hours x 575 non-IND foreign trials x $30 = $552,000). E. Benefits of the Final Rule We believe that improvement in the conduct of clinical trials will improve the quality of clinical data submitted, allowing these data to provide support for applications for marketing approval. We further believe that the final rule will decrease the possibility that subjects in foreign clinical trials will be placed unnecessarily at risk. We have not quantified the benefit of improvements in the data being included with applications for marketing approval resulting from the use of GCP in lieu of previous requirements. However, if these data were determined to be adequate to support an application, beneficial therapies could become available earlier. Similarly, we expect that the greater integrity of data from non-IND studies will result in an additional benefit, also difficult to quantify, due to better quality data about the safety and effectiveness of products and greater public confidence in the scientific basis for FDA decisions. F. Small Business Impact The final rule is not expected to have a significant impact on a substantial number of small entities. Nevertheless, we have prepared a voluntary regulatory flexibility analysis. 1. Nature of the Impact As discussed previously in this document, we estimate that the final rule will increase total costs to sponsors of foreign clinical studies by approximately $552,000 per year. The increased costs will be due to greater costs of review and documentation of the approval of study protocols by IECs. The resources needed to comply with this rule are not specialized. Assuming, for purposes of this calculation, that each of the approximately 115 INDs or applications for marketing approval submitted annually (in which are reported approximately 575 non-IND foreign clinical studies) is submitted by a different sponsor, each sponsor would incur costs of approximately $4,800 per year to comply with the final rule ($552,000 ÷ 115 = $4,800). 2. The Affected Industry The Census of Manufacturers defines the pharmaceutical preparations industry in NAICS 325412. This industry consists of 712 companies and 837 establishments. Average revenues per company are over $100 million annually. However, the Small Business Administration has defined any entity with 750 or fewer employees as a small entity. According to the Census of Manufacturers, approximately 95 percent of the industry establishments would meet this criterion. With the industry-wide average of approximately 1.2 establishments per company, it is likely that at least 90 percent of the companies would be considered small entities. On the other hand, the proportion of sponsors that submit original applications for marketing approval is markedly different from the general industry. We examined the characteristics of sponsors of new drug product applications for marketing approval between October 1996 and October 1999 (Ref. 2). Of the 158 firms that had sponsored applications for marketing approval during that period, 56 (or about 33 percent) were considered domestic small entities (750 or fewer employees). The remaining firms were either foreign sponsors or large innovating enterprises. The 56 small firms submitted a total of 76 NDAs during that period, which is about 1.5 applications each over a 3-year period (or 0.5 annually per small entity). The 76 NDAs submitted by small domestic entities represented about 20 percent of all applications. Using this proportion, we estimate that 20 percent of the 575 annual non-IND foreign clinical trials to develop data for submission in an FDA application for marketing approval (approximately 115 studies) could be sponsored by small entities. If these trials were distributed equally among each sponsoring small entity, each sponsor would be expected to conduct two non-IND clinical trials per year. If so, the compliance costs would equal about $9,600 annually per small entity ($4,800 x 2 = $9,600). The Census of Manufacturers also reports that a sizable proportion of the industry has an annual value of shipments of approximately $1 million. For example, a reported 494 of the 837 establishments had total shipments of approximately $480 million during 1997. The expected cost of $9,600 per small firm would not represent a significant impact. 3. Alternatives to the Final Rule We considered several alternatives to the final rule. We rejected leaving § 312.120 unchanged because it would not meet the objectives of enhancing standards for study conduct and ensuring data integrity. We rejected other regulatory options to increase our oversight of foreign clinical investigations because they would be either too costly or unenforceable. We considered changing the inspection strategy for foreign clinical trials, but this option would not ensure GCP compliance, a process that makes all parties to a study responsible for patient safety and study quality. We considered but rejected allowing an exemption from the requirements in the final rule for small entities. We must have confidence that all clinical investigations submitted as support for an IND or application for marketing approval meet basic standards of reliability, patient safety, and data quality. 4. Outreach We received 32 comments on the proposed rule. There were no comments on the “Analysis of Impacts” discussion. 5. Conclusion For the reasons stated previously, we conclude that the final rule will not result in a significant impact on a substantial number of small entities. G. References The following references have been placed on display in the Division of Dockets Management (HFA-305), Food and Drug Administration, 5630 Fishers Lane, rm. 1061, Rockville, MD 20852, and may be seen by interested persons between 9 a.m. and 4 p.m., Monday through Friday. 1. Department of Health and Human Services, Office of the Inspector General, “The Globalization of Clinical Trials: A Growing Challenge in Protecting Human Subjects,” OEI-01-00-00190, September 2001. 2. FDA, “Who Submits NDAs and ANDAs,” unpublished document, October 1999. List of Subjects in 21 CFR Part 312 Drugs, Exports, Imports, Investigations, Labeling, Medical research, Reporting and recordkeeping requirements, Safety. Therefore, under the Federal Food, Drug, and Cosmetic Act and under authority delegated to the Commissioner of Food and Drugs, 21 CFR part 312 is amended as follows: PART 312—INVESTIGATIONAL NEW DRUG APPLICATION 1. The authority citation for 21 CFR part 312 continues to read as follows: Authority: 21 U.S.C. 321, 331, 351, 352, 353, 355, 356, 371, 381, 382, 383, 393; 42 U.S.C. 262. 2. Section 312.3 is amended in paragraph
(b)by alphabetically adding a definition for “Independent ethics committee” to read as follows: § 312.3 Definitions and interpretations.
(b)* * * *Independent ethics committee (IEC)* means a review panel that is responsible for ensuring the protection of the rights, safety, and well-being of human subjects involved in a clinical investigation and is adequately constituted to provide assurance of that protection. An institutional review board (IRB), as defined in § 56.102(g) of this chapter and subject to the requirements of part 56 of this chapter, is one type of IEC. 3. Section 312.120 is revised to read as follows: § 312.120 Foreign clinical studies not conducted under an IND.
(a)*Acceptance of studies.*
(1)FDA will accept as support for an IND or application for marketing approval (an application under section 505 of the act or section 351 of the Public Health Service Act (the PHS Act) (42 U.S.C. 262)) a well-designed and well-conducted foreign clinical study not conducted under an IND, if the following conditions are met:
(i)The study was conducted in accordance with good clinical practice (GCP). For the purposes of this section, GCP is defined as a standard for the design, conduct, performance, monitoring, auditing, recording, analysis, and reporting of clinical trials in a way that provides assurance that the data and reported results are credible and accurate and that the rights, safety, and well-being of trial subjects are protected. GCP includes review and approval (or provision of a favorable opinion) by an independent ethics committee
(IEC)before initiating a study, continuing review of an ongoing study by an IEC, and obtaining and documenting the freely given informed consent of the subject (or a subject's legally authorized representative, if the subject is unable to provide informed consent) before initiating a study. GCP does not require informed consent in life-threatening situations when the IEC reviewing the study finds, before initiation of the study, that informed consent is not feasible and either that the conditions present are consistent with those described in § 50.23 or § 50.24(a) of this chapter, or that the measures described in the study protocol or elsewhere will protect the rights, safety, and well-being of subjects; and
(ii)FDA is able to validate the data from the study through an onsite inspection if the agency deems it necessary.
(2)Although FDA will not accept as support for an IND or application for marketing approval a study that does not meet the conditions of paragraph (a)(1) of this section, FDA will examine data from such a study.
(3)Marketing approval of a new drug based solely on foreign clinical data is governed by § 314.106 of this chapter.
(b)*Supporting information* . A sponsor or applicant who submits data from a foreign clinical study not conducted under an IND as support for an IND or application for marketing approval must submit to FDA, in addition to information required elsewhere in parts 312, 314, or 601 of this chapter, a description of the actions the sponsor or applicant took to ensure that the research conformed to GCP as described in paragraph (a)(1)(i) of this section. The description is not required to duplicate information already submitted in the IND or application for marketing approval. Instead, the description must provide either the following information or a cross-reference to another section of the submission where the information is located:
(1)The investigator's qualifications;
(2)A description of the research facilities;
(3)A detailed summary of the protocol and results of the study and, should FDA request, case records maintained by the investigator or additional background data such as hospital or other institutional records;
(4)A description of the drug substance and drug product used in the study, including a description of the components, formulation, specifications, and, if available, bioavailability of the specific drug product used in the clinical study;
(5)If the study is intended to support the effectiveness of a drug product, information showing that the study is adequate and well controlled under § 314.126 of this chapter;
(6)The name and address of the IEC that reviewed the study and a statement that the IEC meets the definition in § 312.3 of this chapter. The sponsor or applicant must maintain records supporting such statement, including records of the names and qualifications of IEC members, and make these records available for agency review upon request;
(7)A summary of the IEC's decision to approve or modify and approve the study, or to provide a favorable opinion;
(8)A description of how informed consent was obtained;
(9)A description of what incentives, if any, were provided to subjects to participate in the study;
(10)A description of how the sponsor(s) monitored the study and ensured that the study was carried out consistently with the study protocol; and
(11)A description of how investigators were trained to comply with GCP (as described in paragraph (a)(1)(i) of this section) and to conduct the study in accordance with the study protocol, and a statement on whether written commitments by investigators to comply with GCP and the protocol were obtained. Any signed written commitments by investigators must be maintained by the sponsor or applicant and made available for agency review upon request.
(c)*Waivers* .
(1)A sponsor or applicant may ask FDA to waive any applicable requirements under paragraphs (a)(1) and
(b)of this section. A waiver request may be submitted in an IND or in an information amendment to an IND, or in an application or in an amendment or supplement to an application submitted under part 314 or 601 of this chapter. A waiver request is required to contain at least one of the following:
(i)An explanation why the sponsor's or applicant's compliance with the requirement is unnecessary or cannot be achieved;
(ii)A description of an alternative submission or course of action that satisfies the purpose of the requirement; or
(iii)Other information justifying a waiver.
(2)FDA may grant a waiver if it finds that doing so would be in the interest of the public health.
(d)*Records* . A sponsor or applicant must retain the records required by this section for a foreign clinical study not conducted under an IND as follows:
(1)If the study is submitted in support of an application for marketing approval, for 2 years after an agency decision on that application;
(2)If the study is submitted in support of an IND but not an application for marketing approval, for 2 years after the submission of the IND. Dated: April 21, 2008. Jeffrey Shuren, Associate Commissioner for Policy and Planning. [FR Doc. E8-9200 Filed 4-25-08; 8:45 am] BILLING CODE 4160-01-S DEPARTMENT OF THE TREASURY Alcohol and Tobacco Tax and Trade Bureau 27 CFR Parts 4, 24, and 27 [Docket No. TTB-2007-0006; T.D. TTB-70; Re: T.D. TTB-31 and Notice No. 51] RIN 1513-AB00 Certification Requirements for Imported Natural Wine (2005R-002P) AGENCY: Alcohol and Tobacco Tax and Trade Bureau (TTB), Treasury. ACTION: Final rule; Treasury decision. SUMMARY: The Alcohol and Tobacco Tax and Trade Bureau is adopting as a final rule, without changes, the temporary regulations implementing the certification requirements regarding production practices and procedures for imported natural wine. These requirements were adopted in section 2002 of the Miscellaneous Trade and Technical Corrections Act of 2004 as an amendment to section 5382 of the Internal Revenue Code of 1986. DATES: *Effective Date:* This final rule is effective on May 28, 2008. FOR FURTHER INFORMATION CONTACT: Jennifer Berry, Alcohol and Tobacco Tax and Trade Bureau, Regulations and Rulings Division, P.O. Box 18152, Roanoke, VA 24014; telephone 540-344-9333. SUPPLEMENTARY INFORMATION: Background The Alcohol and Tobacco Tax and Trade Bureau
(TTB)is responsible for the administration of Chapter 51 of the Internal Revenue Code of 1986
(IRC)which includes provisions relating to the taxation of wine. Section 5382(a) of the IRC (26 U.S.C. 5382(a)) sets forth standards regarding what constitutes proper cellar treatment of natural wine. On December 3, 2004, the President signed into law the Miscellaneous Trade and Technical Corrections Act of 2004, Public Law 108-429, 118 Stat. 2434 (“the Act”), which revised section 5382(a) of the IRC to accommodate two new provisions. The first new provision was paragraph (1)(B), which provides that, in the case of wine produced and imported subject to an international agreement or treaty, proper cellar treatment of natural wine includes those practices and procedures acceptable to the United States under the agreement or treaty. The second new provision was paragraph (3), which sets forth a new certification requirement regarding production practices and procedures for imported natural wine produced after December 31, 2004. Under section 5382(a)(3) the Secretary of the Treasury shall accept the practices and procedures used to produce wine in another country if, at the time of importation of the wine, one of the following conditions is met: • The Secretary has on file or is provided with a certification from the government of the producing country, accompanied by an affirmed laboratory analysis, that the practices and procedures used to produce the wine constitute proper cellar treatment under regulations prescribed by the Secretary; • The Secretary has on file or is provided with a certification required by an international agreement or treaty covering proper cellar treatment, or the wine is covered by an international agreement or treaty covering proper cellar treatment that does not require a certification; or • In the case of an importer that owns or controls or that has an affiliate that owns or controls a winery operating under a basic permit issued by the Secretary, the importer certifies that the practices and procedures used to produce the wine constitute proper cellar treatment under regulations prescribed by the Secretary. In addition, for purposes of the certification requirement, section 5382(a)(3) defines “affiliate” as having the meaning contained in section 117(a)(4) of the Federal Alcohol Administration Act (27 U.S.C. 211(a)(4)), and as including “a winery's parent or subsidiary or any other entity in which the winery's parent or subsidiary has an ownership interest.” Temporary Rule and Notice of Proposed Rulemaking On August 24, 2005, TTB published in the **Federal Register** (70 FR 49479) a temporary rule, T.D. TTB-31, which implemented the above described certification requirements by amending 27 CFR parts 4, 24, and 27. In conjunction with the publication of T.D. TTB-31, TTB published a notice of proposed rulemaking, Notice No. 51, in the **Federal Register** (70 FR 49516) on August 24, 2005, referencing and inviting comments on T.D. TTB-31. The comment period closed October 24, 2005. Comments and TTB Analysis TTB received four comments during the comment period. Below, we summarize and respond to the four comments. Comment The Embassy of Switzerland commented that requiring certification for shipments of limited quantities could create impediments to the introduction of new products. It therefore urged TTB to exempt from certification shipments of limited quantities and non-commercial shipments intended for trade fairs or exhibits. TTB Response The implementing regulations include an exemption for importations of commercial samples of natural wine. Under 27 CFR 27.140(b)(2)(ii)(C), commercial samples include sales samples, samples for trade shows, and samples imported for laboratory analysis. We believe this provision addresses the commenter's concern regarding shipments for trade shows and exhibits. We also believe that 27 CFR 27.140(b)(2)(ii)(B), which exempts importations of a personal, non-commercial nature, could apply to many of the shipments of limited quantities mentioned by the commenter. Comment The National Association of Beverage Importers, Inc. (NABI), in its comment, stated that TTB did not define the word “importer” in the temporary regulations, making it unclear who must retain a copy of the certification. It stated that in the industry, “importer” could mean either the “authorized importer” or the “importer of record.” According to NABI, the “authorized importer” is authorized by the foreign supplier to import the supplier's wine into the U.S., whereas the “importer of record” is the importer that physically imports the wine (sic), usually using a certificate of label approval
(COLA)owned by the authorized importer. NABI therefore asked which type of importer must maintain a copy of the certification in their records. NABI believes that the COLA owner should be required to retain the certification. NABI also requested clarification regarding wine that is a blend of wines from multiple suppliers, asking if the importer must obtain certifications for all the wines used in a blend or only for the finished wine. TTB Response “Importer” is defined in § 27.140 of the implementing regulations as “any person importing wine who must obtain a permit as provided in § 27.55.” Under § 27.55, any person who intends to engage in the business of importing wines must obtain a permit from TTB. If a COLA holder is also the actual importer, that COLA holder would have to both obtain a permit and retain the certification, a copy of which is sufficient for this purpose. TTB believes the regulations are sufficiently clear on this point. With regard to NABI's second point, we note that the certification requirement applies to the wine that is imported into the United States, that is, the certification is required only for the finished wine if that is the wine that is imported. If the component wines were imported into the United States for blending here, then the certification requirement would apply to each of the component wines that is imported. If the wine is blended before importation, a certificate is required only for the finished, blended wine. We believe the regulatory language is also sufficiently clear on this point. Comment The Wine Institute filed a comment disagreeing with the position taken by TTB in the temporary rule regarding self-certification, that is, that the statute does not allow self-certification by a winery when the winery owns or controls an importer rather than the other way around. The Wine Institute stated that a winery operating under a basic permit is the more qualified of the two entities to make this certification. The Wine Institute contends that TTB has the authority to infer that Congress did not intend to make this exclusion and that TTB should therefore revise the temporary regulations to allow a winery owning or controlling an importer to self-certify its imports. TTB Response TTB notes that the statutory language contained in 26 U.S.C. 5382(a)(3)(A)(iii) very specifically refers only to an importer that owns or controls a winery or that has an affiliate that owns or controls a winery operating under a basic permit. The statutory language does not suggest that Congress intended the statute also to allow self-certification by a winery that owns or controls an importer or that has an affiliate to that owns or controls an importer. Accordingly, we do not believe Congress intended the interpretation suggested in this comment. Comment The Government of Canada submitted a comment requesting that certain types of Canadian wines—non-grape wines, cider, and wines containing less than 7 percent alcohol by volume—be exempt from the certification requirements. These wines are outside the scope of the “Agreement on Mutual Acceptance of Oenological Practices”
(MAA)signed by several nations including Canada and the United States, which covers only natural grape wines that are at least 7 percent alcohol by volume, and are therefore subject to the certification requirements. Canada contends that an exemption would be justified because Canadian regulations require that fruit wines (other than cider) and wines containing less than 7 percent alcohol by volume must be produced in accordance with the same standards as wines covered by the MAA. Canada also requested consideration of an exemption from the certification requirements for the importation of small quantities of non-grape natural wine from Canada in order to mitigate the potential economic impact on small exporters. Canada stated that because these wines are exported in limited quantities by small exporters the cost of complying with the requirements will be prohibitive and may shut these products out of the U.S. market. Finally, Canada requested that we delay the implementation of the certification requirements until the United States and Canada can reach an agreement on an import certification regime covering these wines. TTB Response We are unable to provide the two requested exemptions. The non-grape wines and other products described by Canada clearly fall within the certification requirements of the statute. The fact that they are produced in accordance with the same standards as wine covered by the scope of the MAA or are only exported in limited quantities cannot override the clear wording of the statute. Regarding the request for a delay in the implementation date, TTB does not have the authority to change the implementation date of the certification requirements, which is prescribed by the statute. TTB Finding Based on the reasons set forth above and on the comments received, we believe it is appropriate to adopt the temporary rule as a final rule without change. Regulatory Flexibility Act We certify that this regulation will not have a significant impact on a substantial number of small entities. This regulation adopts without change a temporary rule that incorporated some reporting and recordkeeping requirements. It was previously concluded that those requirements were expected to be of minimal burden, and we have received no information that contradicts that previous determination. Therefore, no regulatory flexibility analysis is required. Additionally, pursuant to section 7805(f) of the Internal Revenue Code, we submitted the temporary rule to the Chief Counsel for Advocacy of the Small Business Administration for comment on the impact to small businesses. That office did not comment on the temporary rule. Paperwork Reduction Act The collections of information contained in this final regulation have been previously reviewed and approved by the Office of Management and Budget
(OMB)in accordance with the Paperwork Reduction Act of 1995 (44 U.S.C. 3507(d)) and assigned OMB control number 1513-0119. An agency may not conduct or sponsor, and a person is not required to respond to, a collection of information unless it displays a valid control number assigned by OMB. This final rule restates the collection of information without substantive change. Comments concerning suggestions for reducing the burden of the collections of information should be directed to Mary A. Wood, Alcohol and Tobacco Tax and Trade Bureau, at any of these addresses: • P.O. Box 14412, Washington, DC 20044-4412; • 202-927-8525 (facsimile); or • *formcomments@ttb.gov* (e-mail). Executive Order 12866 This rule is not a significant regulatory action as defined in Executive Order 12866. Therefore, it requires no regulatory assessment. Drafting Information The principal author of this document was Jennifer K. Berry, Regulations and Rulings Division, Alcohol and Tobacco Tax and Trade Bureau. Other personnel also participated in its development. List of Subjects 27 CFR Part 4 Advertising, Customs duties and inspection, Imports, Labeling, Packaging and containers, Reporting and recordkeeping requirements, Trade practices, Wine. 27 CFR Part 24 Administrative practice and procedure, Claims, Electronic fund transfers, Excise taxes, Exports, Food additives, Fruit juices, Labeling, Liquors, Packaging and containers, Reporting and recordkeeping requirements, Research, Scientific equipment, Spices and flavoring, Surety bonds, Vinegar, Warehouses, Wine. 27 CFR Part 27 Alcohol and alcoholic beverages, Beer, Customs duties and inspection, Electronic funds transfers, Excise taxes, Imports, Labeling, Liquors, Packaging and containers, Reporting and recordkeeping requirements, Wine. The Regulatory Amendment For the reasons stated in the preamble, the temporary rule published in the **Federal Register** at 70 FR 49479 on August 24, 2005, is adopted as a final rule without change. Signed: January 2, 2008. John J. Manfreda, Administrator. Approved: March 24, 2008. Timothy E. Skud, Deputy Assistant Secretary (Tax, Trade, and Tariff Policy). [FR Doc. E8-9173 Filed 4-25-08; 8:45 am] BILLING CODE 4810-31-P ENVIRONMENTAL PROTECTION AGENCY 40 CFR Part 52 [EPA-HQ-OAR-2007-0510; FRL-8556-1] Withdrawal of Federal Implementation Plans for the Clean Air Interstate Rule in 12 States AGENCY: Environmental Protection Agency (EPA). ACTION: Final rule. SUMMARY: EPA is withdrawing Federal Implementation Plans
(FIPs)for the Clean Air Interstate Rule
(CAIR)in Alabama, Arkansas, Florida, Georgia, Illinois, Iowa, Kentucky, Louisiana (SO 2 FIP trading program only), Massachusetts, Mississippi, Missouri, and Virginia because these 12 states have previously submitted and received EPA approval of full state implementation plans
(SIPs)to meet the CAIR requirements. When EPA issued the CAIR FIPs on April 28, 2006, it stated that it would withdraw the FIPs in a state in coordination with the approval of the CAIR SIP for that state. Also, when EPA approved the CAIR SIPs for these states, it explained that it would take a separate action to remove the CAIR FIPs for those states. EPA is now acting to formally withdraw the FIPs for 12 states. This action is necessary because EPA's approval of those states' CAIR SIPs corrected the deficiency that provided the basis for EPA's promulgation of the FIPs. EPA is also removing the CAIR FIP regulatory text for Connecticut and New York. The FIPs for these states have already been automatically withdrawn pursuant to a rulemaking published on November 2, 2007. This ministerial action is necessary to correct the regulatory text. DATES: This final rule is effective on April 28, 2008. ADDRESSES: EPA has established a docket for this rulemaking under Docket ID number EPA-HQ-OAR-2007-0510. (The docket for the CAIR FIP rulemaking is EPA-HQ-OAR-2004-0076 and the docket for the CAIR is EPA-HQ-OAR-2003-0053.) All documents in the docket are listed in the *http://www.regulations.gov* index. Although listed in the index, some information is not publicly available, e.g., confidential business information or other information whose disclosure is restricted by statute. Certain other material, such as copyrighted material, is not placed on the Internet and will be publicly available only in hard copy. Publicly available docket materials are available either electronically in *http://www.regulations.gov* or in hard copy at the EPA Docket Center EPA/DC, EPA West, Room 3334, 1301 Constitution Ave., NW., Washington, DC. The Public Reading Room is open from 8:30 a.m. to 4:30 p.m., Monday through Friday, excluding legal holidays. The telephone number for the Public Reading Room is
(202)566-1744, and the telephone number for the EPA Docket Center is
(202)566-1742. Rulemaking actions for the CAIR and CAIR FIPs are also available at EPA's CAIR Web site at *http://www.epa.gov/cair* . The **Federal Register** citations for the SIP approval actions for the states addressed in this rule are provided in section III below. FOR FURTHER INFORMATION CONTACT: Carla Oldham, Air Quality Planning Division, Office of Air Quality Planning and Standards, mail code C539-04, Environmental Protection Agency, Research Triangle Park, North Carolina 27711; telephone number: 919-541-3347; fax number: 919-541-0824; e-mail address: *oldham.carla@epa.gov* . SUPPLEMENTARY INFORMATION: Outline I. General Information A. Does This Action Apply to Me? B. Judicial Review II. What Is the Background for This Rule? III. What Is This Final Action? A. Withdrawal of CAIR FIPs in 12 States B. Removal of CAIR FIP Regulatory Text for New York and Connecticut C. Updating the CAIR FIP Regulatory Text IV. What Is the Rulemaking Procedure? V. Statutory and Executive Order Reviews I. General Information A. Does This Action Apply to Me? This action does not establish any control requirements. It withdraws the CAIR FIPs in Alabama, Arkansas, Florida, Georgia, Illinois, Iowa, Kentucky, Louisiana (SO 2 FIP trading program only), Massachusetts, Mississippi, Missouri, and Virginia because these states previously have submitted and received full EPA approval of SIPs to meet the CAIR requirements. EPA promulgated the CAIR FIPs on April 28, 2006 (71 FR 25328). Categories and entities potentially regulated by the CAIR FIPs include the following: Category NAICS code 1 Examples of potentially regulated entities Industry 221112 Fossil fuel-fired electric utility steam generating units. Federal government 2 221122 Fossil fuel-fired electric utility steam generating units owned by the Federal government. State/local/Tribal government 2 221122 Fossil fuel-fired electric utility steam generating units owned by municipalities. 921150 Fossil fuel-fired electric utility steam generating units in Indian Country. 1 North American Industry Classification System. 2 Federal, state, or local government-owned and operated establishments are classified according to the activity in which they are engaged. This table is not intended to be exhaustive, but rather provides a guide for readers regarding entities likely to be regulated by the CAIR FIPs in states that continue to be affected by the FIPs. To determine whether your facility is affected by the CAIR FIPs, in states where the FIP still applies, you should examine the definitions and applicability criteria in 40 CFR 97.102, 97.104, 97.105, 97.202, 97.204, 97.205, 97.302, 97.304, and 97.305. B. Judicial Review Under CAA section 307(b), judicial review of this final action is available only by filing a petition for review in the U.S. Court of Appeals for the District of Columbia Circuit on or before June 27, 2008. Moreover, under CAA section 307(b)(2), the requirements established by this final rule may not be challenged separately in any civil or criminal proceedings brought by EPA to enforce these requirements. II. What Is the Background for This Rule? In a final rule published on April 25, 2005 (70 FR 21147), effective May 25, 2005, EPA made national findings that states had failed to submit SIPs required under section 110(a)(2)(D)(i) of the Clean Air Act
(CAA)to address interstate transport with respect to the PM 2.5 and 8-hour ozone national ambient air quality standards (NAAQS). These SIPs were due in July 2000, 3 years after the promulgation of the PM <sup>2.5</sup> and 8-hour ozone NAAQS. The findings started a 2-year clock for EPA to promulgate FIPs to address the requirements of section 110(a)(2)(D)(i). Under section 110(c)(1), EPA may issue a FIP any time after such findings are made and must do so unless a SIP revision correcting the deficiency is approved by EPA before the FIP is promulgated. On May 12, 2005 (70 FR 25162), EPA issued the CAIR, which established the levels of NO <sup>X</sup> and SO 2 emission reduction requirements necessary for CAIR-affected states to address their significant 8-hour ozone and PM 2.5 interstate transport. ( *See also* CAIR revisions on April 28, 2006; 71 FR 25288 and December 13, 2006; 71 FR 74792.) NO <sup>X</sup> emissions are precursors to 8-hour ozone and PM 2.5 ; SO 2 emissions are precursors to PM 2.5 . The CAIR affects 28 states and the District of Columbia (collectively, CAIR states) in the eastern half of the country. All CAIR states were required to submit their CAIR SIPs by September 11, 2006. For states subject to the CAIR requirements, an approved CAIR SIP corrects the section 110(a)(2)(D)(i) deficiency identified in the April 25, 2005 findings action. In a final rule published on April 28, 2006 (71 FR 25328), EPA promulgated FIPs as a backstop to implement the CAIR requirements in all CAIR states. As the control requirement for the FIPs, EPA adopted the model trading rules for electric generating units
(EGUs)that EPA provided in CAIR as a control option for states, with minor changes to account for Federal rather than state implementation. The FIPs were promulgated to regulate EGUs in the affected states and achieve the emissions reduction requirements established by the CAIR until states promulgated and received EPA approval of SIPs to achieve the reductions. In the FIP preamble, EPA stated it would withdraw the FIP in a state in coordination with the approval of the CAIR SIP for that state. Because EPA's authority to issue the FIPs was premised on the section 110(a)(2)(D)(i) deficiency identified in the April 25, 2005, findings action, once EPA fully approves a full SIP 1 to correct that deficiency for a state, EPA no longer has the authority for the FIP in that state. 1 The CAIR FIPs also provide that states may submit “abbreviated” SIP revisions to replace or supplement specific elements of the FIPs, leaving the remainder of the overall FIPs in place, rather than submitting “full” CAIR SIP revisions that replace the FIPs. The abbreviated SIP revisions, when approved, will automatically replace or supplement the corresponding CAIR FIP provisions. ( *See* 71 FR at 25345-25346 for further details.) This rule only addresses States that submitted full CAIR SIPs. On November 2, 2007 (72 FR 62338), EPA published a final rule to amend the CAIR FIPs to make FIP withdrawal automatic upon the effective date of EPA's approval of a full SIP revision meeting the CAIR requirements. This rule became effective on January 16, 2008. For full CAIR SIPs whose EPA approvals are effective on or after that date, EPA will not need to take further action to withdraw the FIP. However, the automatic CAIR FIP withdrawal provisions do not apply retroactively. Therefore, EPA is issuing this separate final rule to withdraw the CAIR FIPs in states whose full CAIR SIP approvals have effective dates prior to January 16, 2008. III. What Is This Final Action? A. Withdrawal of CAIR FIPs in 12 States In this final action, EPA is withdrawing CAIR FIPs in the 12 states listed below because the states previously have submitted and received EPA approval of full SIPs to meet the CAIR requirements and the SIP approvals are effective. These SIP approvals became effective prior to January 16, 2008. Therefore, as discussed above, the automatic FIP withdrawal provisions, which became effective on January 16, 2008, do not apply. EPA promulgated the FIPs based on findings that the affected states had failed to submit SIPs to address the requirements of CAA 110(a)(2)(D)(i). EPA's approval of the full CAIR SIPs corrects the 110(a)(2)(D)(i) deficiency for the listed states and thus also removes the basis for the FIPs in that state. All of these 12 states have chosen to participate in the EPA-administered trading programs that EPA provided in the CAIR as highly cost-effective options for meeting the CAIR requirements. The SIP approval actions provide details on the states' trading programs. Except for Louisiana, the full SIPs address all of the CAIR requirements in the state. Louisiana adopted a full SIP to address the SO 2 requirements for PM 2.5 , but adopted an abbreviated SIP to address the annual and ozone season NO <sup>X</sup> requirements for PM 2.5 and ozone. Therefore, EPA is only withdrawing the FIP SO 2 requirements in Louisiana. The EPA has not yet taken any action under the relevant FIP trading programs for these states, such as recording the initial set of NO <sup>X</sup> allocations, that would preclude EPA from fully withdrawing the FIPs in these states. The final CAIR SIP approvals were published in the **Federal Register** on the dates given below. Alabama EPA's full approval of Alabama's CAIR SIP for the 8-hour ozone and PM <sup>2.5</sup> NAAQS was published on October 1, 2007 (72 FR 55659) and effective on October 31, 2007. Therefore, EPA is withdrawing the CAIR FIP requirements for Alabama under 40 CFR 52.54 for annual and ozone season NO <sup>X</sup> emissions and under 40 CFR 52.55 for to SO <sup>2</sup> emissions. Arkansas EPA's full approval of Arkansas's CAIR SIP for the 8-hour ozone NAAQS was published on September 26, 2007 (72 FR 54556) and effective November 26, 2007. Therefore, EPA is withdrawing the CAIR FIP requirements for Arkansas under 40 CFR 52.184 for ozone season NO <sup>X</sup> emissions. Florida EPA's full approval of Florida's CAIR SIP for the 8-hour ozone and PM <sup>2.5</sup> NAAQS was published October 12, 2007 (72 FR 58016) and effective November 13, 2007. Therefore, EPA is withdrawing the CAIR FIP requirements for Florida under 40 CFR 52.540 for annual and ozone season NO <sup>X</sup> emissions and under 40 CFR 52.541 for SO <sup>2</sup> emissions. Georgia EPA's full approval of Georgia's CAIR SIP for the PM <sup>2.5</sup> NAAQS was published on October 9, 2007 (72 FR 57202) and effective November 8, 2007. Therefore, EPA is withdrawing the CAIR FIP requirements for Georgia under 40 CFR 52.584 for annual NO <sup>X</sup> emissions and under 40 CFR 52.585 for SO <sup>2</sup> emissions. Illinois EPA's full approval of Illinois' CAIR SIP for the 8-hour ozone and PM <sup>2.5</sup> NAAQS was published on October 16, 2007 (72 FR 58528) and effective December 17, 2007. Therefore, EPA is withdrawing the CAIR FIP requirements for Illinois under 40 CFR 52.745 for annual and ozone season NO <sup>X</sup> emissions and under 40 CFR 52.746 for SO <sup>2</sup> emissions. Iowa EPA's full approval of Iowa's CAIR SIP for the 8-hour ozone and PM <sup>2.5</sup> NAAQS was published August 6, 2007 (72 FR 43539) and effective September 5, 2007. Therefore, EPA is withdrawing the CAIR FIP requirements for Iowa under 40 CFR 52.840 for annual and ozone season NO <sup>X</sup> emissions and under 40 CFR 52.841 for SO <sup>2</sup> emissions. Kentucky EPA's full approval of Kentucky's CAIR SIP for the 8-hour ozone and PM <sup>2.5</sup> NAAQS was published October 4, 2007 (72 FR 56623) and effective December 3, 2007. Therefore, EPA is withdrawing the CAIR FIP requirements for Kentucky under 40 CFR 52.940 for annual and ozone season NO <sup>X</sup> emissions and under 40 CFR 52.941 for SO <sup>2</sup> emissions. Louisiana EPA's approval of Louisiana's full CAIR SO <sup>2</sup> SIP for the PM <sup>2.5</sup> NAAQS was published on July 20, 2007 (72 FR 39741) and effective on September 18, 2007. Therefore, EPA is withdrawing the FIP requirements for Alabama under 40 CFR part 52.985 for SO <sup>2</sup> emissions. (Louisiana adopted an abbreviated SIP for annual and ozone season NO <sup>X</sup> emissions for the PM <sup>2.5</sup> and 8-hour ozone NAAQS, respectively (72 FR 55064; September 28, 2007).) Massachusetts EPA's approval of Massachusetts's CAIR SIP for the ozone NAAQS was published on December 3, 2007 (72 FR 67854) and effective on December 3, 2007. Therefore, EPA is withdrawing the CAIR FIP requirements for Massachusetts under 40 CFR 52.1140 for ozone season NO <sup>X</sup> emissions. Mississippi EPA's approval of Mississippi's CAIR SIP for the 8-hour ozone and PM <sup>2.5</sup> NAAQS was published October 3, 2007 (72 FR 56268) and effective on November 2, 2007. Therefore, EPA is withdrawing the CAIR FIP requirements for Mississippi under 40 CFR 52.1284 for annual and ozone season NO <sup>X</sup> emissions and under 40 CFR 52.1285 for SO <sup>2</sup> emissions. Missouri EPA's approval of Missouri's CAIR SIP for the 8-hour ozone and PM <sup>2.5</sup> NAAQS was published on December 14, 2007 (72 FR 71073) and effective on December 14, 2007. Therefore, EPA is withdrawing the CAIR FIP requirements for Missouri under 40 CFR 52.1341 for annual and ozone season NO <sup>X</sup> emissions and under 40 CFR 52.1342 for SO <sup>2</sup> emissions. Virginia EPA's approval of Virginia's CAIR SIP for the 8-hour ozone and PM <sup>2.5</sup> NAAQS was published on December 28, 2007 (72 FR 73602) and effective on December 28, 2007. Therefore, EPA is withdrawing the CAIR FIP requirements for Virginia under 40 CFR 52.2440 for annual and ozone season NO <sup>X</sup> emissions and under 40 CFR 52.2441 for SO <sup>2</sup> emissions. B. Removal of CAIR FIP Regulatory Text for New York and Connecticut EPA is also taking ministerial action to remove the CAIR FIP regulatory text for Connecticut and New York. The CAIR SIP approvals for these states became effective after the January 16, 2008 effective date of EPA's automatic FIP withdrawal rule (72 FR 62338; November 2, 2007). Therefore, the FIPs for these states were automatically withdrawn pursuant to that rule. This current action removes the associated FIP regulatory text to reflect that the FIPs have been withdrawn. EPA's approval of Connecticut's CAIR SIP for the 8-hour ozone NAAQS was published and effective on January 24, 2008 (73 FR 4105). Therefore, the CAIR FIP for Connecticut was withdrawn on January 24, 2008 and EPA is removing the CAIR FIP regulatory text for Connecticut under 40 CFR 52.386 for ozone season NO <sup>X</sup> emissions. EPA's approval of New York's CAIR SIP for the 8-hour ozone and PM <sup>2.5</sup> NAAQS was published and effective on January 24, 2008 (73 FR 4109). Therefore, the CAIR FIPs for New York were withdrawn on January 24, 2008 and EPA is removing the CAIR FIP regulatory text for New York under 40 CFR 1684 for annual and ozone season NO <sup>X</sup> emissions and under 40 CFR 52.1685 for SO <sup>2</sup> emissions. To meet the CAIR requirements, Connecticut and New York both chose to participate in the EPA-administered cap and trade programs that EPA provided in the CAIR. In the future, EPA will be removing the CAIR FIP regulatory text for a state in the context of the CAIR SIP approval action for the state. Thus, a separate action to remove the CAIR FIP regulatory text will not be needed. C. Updating the CAIR FIP Regulatory Text This action updates the regulatory text in 40 CFR part 52 to reflect the withdrawal of the FIPs for the states discussed above. In some instances, EPA is not only removing the regulatory text, but also reserving the section where the regulatory text had been. This has no substantive impact and is being done solely to preserve the numbering of sections in the Code of Federal Regulations according a protocol established by the Office of the Federal Register. IV. What Is the Rulemaking Procedure? The EPA is taking this action as a final rule without providing an additional opportunity for public comment or a public hearing because EPA finds that the Administrative Procedure Act
(APA)good cause exemption applies here. Section 553 of the APA, 5 U.S.C. 553(b)(B), provides that when an Agency for good cause finds that notice and public procedure are impracticable, unnecessary, or contrary to public interest, the Agency may issue a rule without providing notice and an opportunity to comment. The EPA has determined that it is not necessary or in the public interest to provide a public hearing or an additional opportunity for public comment on this action because the withdrawal of the FIPs in these states is a necessary ministerial act. As explained above, once EPA fully approves a CAIR SIP for a state and that approval is effective, EPA no longer has the authority for the CAIR FIPs in that state. Therefore, EPA is taking this action to remove the regulatory text that applies the FIP requirements to sources in states listed above. Since the SIPs are already effective and sources in these states are subject to the requirements of the SIP for their state, EPA's withdrawal of the FIPs has no practical consequences. Further, since the SIP approvals remove EPA's authority for the FIPs, EPA believes it has no option but to withdraw the FIPs. If EPA were to decide to reconsider or reverse a SIP approval action, it would take any appropriate action with regard to the FIP at that time. For these reasons, it would serve no useful purpose to provide an additional opportunity for public comment or a public hearing on this issue. EPA also finds that it would be contrary to the public interest to delay issuing this rule in order to offer additional comment opportunities. Promulgation of this rule as soon as possible following the SIP approval serves to clarify that sources initially covered by the FIPs in these states are now covered by the requirements of the SIPs in these states. For these reasons, EPA hereby finds for good cause, pursuant to section 553 of the APA, 5 U.S.C. 553(b)(B), that it would be unnecessary and contrary to public interest for EPA to offer an additional opportunity for public comment and a public hearing on this rule. Therefore, pursuant to CAA 307(d)(1) the requirements of 307(d), including the requirement for a public hearing, do not apply to this action. Further, EPA previously provided public notice that the withdrawal of the FIP would be a necessary consequence of the SIP approval. In the CAIR FIP rulemaking, EPA explained that it would withdraw the FIP in a state in coordination with the CAIR SIP approval. In developing the FIP, EPA provided an opportunity for comment and held two public hearings. Further, in proposing to approve each SIP, EPA noted that the FIP withdrawal would be one necessary consequence of the SIP approval. This process provided the public with ample opportunity to comment on the substantive issues related to the SIP approval. To provide an additional opportunity for public comment and a public hearing on the FIP withdrawal action, which cannot alter or affect the terms of the SIP approval, would serve no useful purpose and is thus unnecessary. EPA has also determined that it is appropriate for this rule to become effective immediately upon publication. Section 553(d) of the APA allows the agency to give a rule an effective date that is less than 30 days after the rules publication date in certain circumstances, two of which apply here. First, section 553(d)(1) allows the effective date to be less than 30 days after the publication date if the rule is “a substantive rule which * * * relieves a restriction.” This action withdraws a federal regulation for 12 states and thus qualifies as a substantive rule which relieves a restriction within the meaning of 553(d)(1). Second, section 553(d)(3) also allows the effective date to be less than 30 days after the publication date “as otherwise provided by the agency for good cause found and published with the rule.” As explained above, promulgation of this rule as soon as possible following the SIP approval serves to clarify that sources initially covered by the FIPs in these states are now covered by the requirements of the states' SIP. V. Statutory and Executive Order Reviews Under Executive Order 12866, Regulatory Planning and Review (58 FR 51735, October 4, 1993), this action is not a “significant regulatory action” and, therefore, is not subject to review by the Office of Management and Budget. This action is not a “major rule” as defined by 5 U.S.C. 804(2). The FIP withdrawal does not impose an information collection burden under the provisions of the Paperwork Reduction Act of 1995 (44 U.S.C. 3501 *et seq.* ). Because EPA has made a “good cause” finding that this action is not subject to notice-and-comment requirements under the APA or any other statute, it is not subject to the regulatory flexibility provisions of the Regulatory Flexibility Act (5 U.S.C. 601 *et seq.* ), or to sections 202 and 205 of the Unfunded Mandates Reform Act of 1995
(UMRA)(Pub. L. 104B4). In addition, this action does not significantly or uniquely affect small governments or impose a significant intergovernmental mandate, as described in sections 203 and 204 of the UMRA. This FIP withdrawal rule does not have substantial direct effects on the states, or on the relationship between the national government and the states, or on the distribution of power and responsibilities among the various levels of government, as specified in Executive Order 13132, Federalism (64 FR 43255, August 10, 1999). This action also does not significantly or uniquely affect the communities of Tribal governments, as specified in Executive Order 13175, Consultation and Coordination with Indian Tribal Governments (65 FR 67249, November 9, 2000). The FIP withdrawal rule is not subject to Executive Order 13045, Protection of Children from Environmental Health and Safety Risks (62 FR 19885, April 23, 1997) because this action is not economically significant. The FIP withdrawal rule is not subject to Executive Order 13211, Actions Concerning Regulations That Significantly Affect Energy Supply, Distribution, or Use (66 FR 28355, May 22, 2001) because this action is not a significant regulatory action under Executive Order 12866. The FIP withdrawal rule does not involve changes to technical standards related to test methods or monitoring methods; thus, the requirements of section 12(d) of the National Technology Transfer and Advancement Act of 1995 (15 U.S.C. 272) do not apply. The FIP withdrawal rule also does not involve special consideration of environmental justice-related issues as required by Executive Order 12898, Federal Actions to Address Environmental Justice in Minority Populations and Low-Income Populations (59 FR 7629, February 16, 1994). The Congressional Review Act, 5 U.S.C. 801 et seq., as added by the Small Business Regulatory Enforcement Fairness Act of 1996 (SBREFA), generally provides that before a rule may take effect, the agency promulgating the rule must submit a rule report, which includes a copy of the rule, to each House of the Congress and to the Comptroller General of the United States. Section 808 of the CRA provides an exception to this requirement. For any rule for which an agency for good cause finds that notice and comment are impracticable, unnecessary, or contrary to the public interest, the rule may take effect on the date set by the Agency. The EPA will submit a report containing this rule and other required information to the U.S. Senate, the U.S. House of Representatives, and the Comptroller General of the United States prior to publication of the rule in the **Federal Register** . This action is not a “major rule” as defined by 5 U.S.C. 804(2). The final rule will be effective on April 28, 2008. The EPA's compliance with the above statutes and Executive Orders for the underlying rules are discussed in section X of the CAIR at 70 FR 25305 and in section IX of the CAIR FIPs at 71 FR 25365. List of Subjects in 40 CFR Part 52 Environmental protection, Administrative practice and procedure, Air pollution control, Electric utilities, Intergovernmental relations, Nitrogen oxides, Ozone, Particulate matter, Reporting and recordkeeping requirements, Sulfur dioxide. Dated: April 16, 2008. Stephen L. Johnson, Administrator. For the reasons set forth in the preamble, part 52 of chapter I of title 40 of the Code of Federal Regulations is amended as follows: PART 52—[AMENDED] 1. The authority citation for part 52 continues to read as follows: Authority: 42 U.S.C. 7401 *et seq* . Subpart B—Alabama § 52.54 [Removed and reserved] 2. Section 52.54 is removed and reserved. § 52.55 [Removed and reserved] 3. Section 52.55 is removed and reserved. Subpart E—Arkansas § 52.184 [Removed] 4. Section 52.184 is removed. Subpart H—Connecticut § 52.386 [Removed] 5. Section 52.386 is removed. Subpart K—Florida § 52.540 [Removed] 6. Section 52.540 is removed. § 52.541 [Removed] 7. Section 52.541 is removed. Subpart L—Georgia § 52.584 [Removed] 8. Section 52.584 is removed. § 52.585 [Removed] 9. Section 52.585 is removed. Subpart O—Illinois § 52.745 [Removed] 10. Section 52.745 is removed. § 52.746 [Removed] 11. Section 52.746 is removed. Subpart Q—Iowa § 52.840 [Removed] 12. Section 52.840 is removed. § 52.841 [Removed] 13. Section 52.841 is removed. Subpart S—Kentucky § 52.940 [Removed] 14. Section 52.940 is removed. § 52.941 [Removed] 15. Section 52.941 is removed. Subpart T—Louisiana § 52.985 [Removed and reserved] 16. Section 52.985 is removed and reserved. Subpart W—Massachusetts § 52.1140 [Removed and reserved] 17. Section 52.1140 is removed and reserved. Subpart Z—Mississippi § 52.1284 [Removed] 18. Section 52.1284 is removed. § 52.1285 [Removed] 19. Section 52.1285 is removed. Subpart AA—Missouri § 52.1341 [Removed] 20. Section 52.1341 is removed. § 52.1342 [Removed] 21. Section 52.1342 is removed. Subpart HH—New York § 52.1684 [Removed] 22. Section 52.1684 is removed. § 52.1685 [Removed] 23. Section 52.1685 is removed. Subpart VV—Virginia § 52.2440 [Removed and reserved] 24. Section 52.2440 is removed and reserved. § 52.2441 [Removed and reserved] 25. Section 52.2441 is removed and reserved. [FR Doc. E8-9219 Filed 4-25-08; 8:45 am] BILLING CODE 6560-50-P ENVIRONMENTAL PROTECTION AGENCY 40 CFR Part 180 [EPA-HQ-OPP-2006-0855; FRL-8360-5] Metconazole; Pesticide Tolerances AGENCY: Environmental Protection Agency (EPA). ACTION: Final rule. SUMMARY: This regulation establishes tolerances for residues of metconazole in or on wheat, barley, rye, oat, sugar beet, and soybeans. BASF Corporation requested these tolerances under the Federal Food, Drug, and Cosmetic Act (FFDCA). This regulation also establishes tolerances for residues of metconazole in or on stone fruit, tree nuts, and peanuts. Valent U.S.A. Corporation requested these tolerances under the Federal Food, Drug, and Cosmetic Act (FFDCA). DATES: This regulation is effective April 28, 2008. Objections and requests for hearings must be received on or before June 27, 2008, and must be filed in accordance with the instructions provided in 40 CFR part 178 (see also Unit I.C. of the SUPPLEMENTARY INFORMATION ). ADDRESSES: EPA has established a docket for this action under docket identification
(ID)number EPA-HQ-OPP-2006-0855. To access the electronic docket, go to *http://www.regulations.gov* , select “Advanced Search,” then “Docket Search.” Insert the docket ID number where indicated and select the “Submit” button. Follow the instructions on the regulations.gov website to view the docket index or access available documents. All documents in the docket are listed in the docket index available in regulations.gov. Although listed in the index, some information is not publicly available, e.g., Confidential Business Information
(CBI)or other information whose disclosure is restricted by statute. Certain other material, such as copyrighted material, is not placed on the Internet and will be publicly available only in hard copy form. Publicly available docket materials are available in the electronic docket at *http://www.regulations.gov* , or, if only available in hard copy, at the OPP Regulatory Public Docket in Rm. S-4400, One Potomac Yard (South Bldg.), 2777 S. Crystal Dr., Arlington, VA. The Docket Facility is open from 8:30 a.m. to 4 p.m., Monday through Friday, excluding legal holidays. The Docket Facility telephone number is
(703)305-5805. FOR FURTHER INFORMATION CONTACT: Tracy Keigwin, Registration Division (7505P), Office of Pesticide Programs, Environmental Protection Agency, 1200 Pennsylvania Ave., NW., Washington, DC 20460-0001; telephone number:
(703)305-6605; e-mail address: *keigwin.tracy @epa.gov* . SUPPLEMENTARY INFORMATION: I. General Information A. Does this Action Apply to Me? You may be potentially affected by this action if you are an agricultural producer, food manufacturer, or pesticide manufacturer. Potentially affected entities may include, but are not limited to those engaged in the following activities: • Crop production (NAICS code 111). • Animal production (NAICS code 112). • Food manufacturing (NAICS code 311). • Pesticide manufacturing (NAICS code 32532). This listing is not intended to be exhaustive, but rather to provide a guide for readers regarding entities likely to be affected by this action. Other types of entities not listed in this unit could also be affected. The North American Industrial Classification System (NAICS) codes have been provided to assist you and others in determining whether this action might apply to certain entities. If you have any questions regarding the applicability of this action to a particular entity, consult the person listed under FOR FURTHER INFORMATION CONTACT . B. How Can I Access Electronic Copies of this Document? In addition to accessing an electronic copy of this **Federal Register** document through the electronic docket at *http://www.regulations.gov* , you may access this **Federal Register** document electronically through the EPA Internet under the “ **Federal Register** ” listings at *http://www.epa.gov/fedrgstr* . You may also access a frequently updated electronic version of EPA's tolerance regulations at 40 CFR part 180 through the Government Printing Office's pilot e-CFR site at *http://www.gpoaccess.gov/ecfr* . C. Can I File an Objection or Hearing Request? Under section 408(g) of FFDCA, any person may file an objection to any aspect of this regulation and may also request a hearing on those objections. You must file your objection or request a hearing on this regulation in accordance with the instructions provided in 40 CFR part 178. To ensure proper receipt by EPA, you must identify docket ID number EPA-HQ-OPP-2006-0855 in the subject line on the first page of your submission. All requests must be in writing, and must be mailed or delivered to the Hearing Clerk as required by 40 CFR part 178 on or before June 27, 2008. In addition to filing an objection or hearing request with the Hearing Clerk as described in 40 CFR part 178, please submit a copy of the filing that does not contain any CBI for inclusion in the public docket that is described in ADDRESSES . Information not marked confidential pursuant to 40 CFR part 2 may be disclosed publicly by EPA without prior notice. Submit this copy, identified by docket ID number EPA-HQ-OPP-2006-0855, by one of the following methods: • *Federal eRulemaking Portal* : *http://www.regulations.gov* . Follow the on-line instructions for submitting comments. • *Mail* : Office of Pesticide Programs
(OPP)Regulatory Public Docket (7502P), Environmental Protection Agency, 1200 Pennsylvania Ave., NW., Washington, DC 20460-0001. • *Delivery* : OPP Regulatory Public Docket (7502P), Environmental Protection Agency, Rm. S-4400, One Potomac Yard (South Bldg.), 2777 S. Crystal Dr., Arlington, VA. Deliveries are only accepted during the Docket's normal hours of operation (8:30 a.m. to 4 p.m., Monday through Friday, excluding legal holidays). Special arrangements should be made for deliveries of boxed information. The Docket Facility telephone number is
(703)305-5805. II. Petition for Tolerance In the **Federal Register** of February 13, 2008 (73 FR 8307) (FRL-8351-5), EPA issued a notice pursuant to section 408(d)(3) of FFDCA, 21 U.S.C. 346a(d)(3), announcing the filing of a pesticide petition (PP 6F7094) by BASF Corporation, 26 Davis Dr., P.O. Box 13528, Research Triangle Park, NC 27709-3528. The petition requested that 40 CFR 180.617 be amended by establishing tolerances for residues of the fungicide metconazole, 5-[(4-chlorophenyl)-methyl]-2,2-dimethyl-1-(1 *H* -1,2,4-triazol-1-ylmethyl)cyclopentanol, measured as the sum of *cis* - and *trans* -isomers in or on food commodities barley, grain at 2.0 parts per million (ppm); barley, hay at 7.0 ppm; barley straw at 7.0 ppm; beet, sugar, root at 0.1 ppm; beet, sugar, tops at 2.0 ppm; beet, sugar, pulp, dry at 1.9 ppm; beet, sugar, molasses at 0.2 ppm; beet, sugar, raw at 0.25 ppm; oat, grain at 1.0 ppm; oat, straw at 6.0 ppm; oat, hay at 17 ppm; rye, grain at 0.25 ppm; rye, straw at 14.0 ppm; soybean, forage at 3.0 ppm; soybean, hay at 6.0 ppm; soybean, seed at 0.10 ppm; soybean, aspirated grain fractions at 1.0 ppm; soybean, hulls at 0.2 ppm; triticale at 0.25 ppm, wheat, grain at 0.15 ppm; wheat, hay at 16.0 ppm; wheat, straw at 18.0 ppm; wheat, aspirated grain fractions at 10.0 ppm; wheat, milled byproducts at 1.0 ppm. That notice referenced a summary of the petition prepared by BASF Corporation, the registrant, which is available to the public in the docket, *http://www.regulations.gov* . There were no comments received in response to the notice of filing. Additionally, in the **Federal Register** of February 13, 2008 (73 FR 8307) (FRL-8351-5), EPA issued a notice pursuant to section 408(d)(3) of FFDCA, 21 U.S.C. 346a(d)(3), announcing the filing of a pesticide petition (PP 6F7095) by Valent U.S.A. Company, 1600 Riviera Ave., Suite 200, Walnut Creek, CA 94596-8025. The petition requested that 40 CFR 180.617 be amended by establishing tolerances for residues of the fungicide metconazole, 5-[(4-chlorophenyl)-methyl]-2,2-dimethyl-1-(1 *H* -1,2,4-triazol-1-ylmethyl)cyclopentanol, measured as the sum of *cis-* and trans-isomers in or on food commodities fruits, stone (crop group 12) at 0.2 ppm; nuts, tree (crop group 14) including pistachio at 0.02 ppm; almond hulls at 5.0 ppm; and peanut at 0.02 ppm. That notice referenced a summary of the petition prepared by Valent U.S.A. Corporation, the registrant, which is available to the public in the docket, *http://www.regulations.gov* . There were no comments received in response to the notice of filing. Based upon review of the data supporting the petition, EPA has modified the proposed tolerance levels as follows: Almond, hulls at 4.0 ppm; barley, grain at 2.5 ppm; beet, sugar, dried pulp at 0.70 ppm; beet, sugar, molasses at 0.08 ppm; beet, sugar, roots at 0.07 ppm; grain, aspirated grain fractions at 7.0 ppm; nut, tree, group 14 at 0.04 ppm; oat, grain at 1.0 ppm; peanut at 0.04 ppm; peanut, refined oil at 0.05 ppm; pistachio at 0.04 ppm; soybean, hulls at 0.08 ppm; soybean, seed at 0.05 ppm; wheat, milled byproducts at 0.20 ppm; and meat byproducts of cattle, goat, horse, and sheep at 0.04 ppm. Additionally, EPA is not establishing the tolerances requested for beet, sugar; sugar beet tops; and soybean meal. Finally, EPA has added tolerances for peanut, refined oil; for meat byproducts of cattle, goat, horse, and sheep. The reason for these changes is explained in Unit IV.D. III. Aggregate Risk Assessment and Determination of Safety Section 408(b)(2)(A)(i) of FFDCA allows EPA to establish a tolerance (the legal limit for a pesticide chemical residue in or on a food) only if EPA determines that the tolerance is “safe.” Section 408(b)(2)(A)(ii) of FFDCA defines “safe” to mean that “there is a reasonable certainty that no harm will result from aggregate exposure to the pesticide chemical residue, including all anticipated dietary exposures and all other exposures for which there is reliable information.” This includes exposure through drinking water and in residential settings, but does not include occupational exposure. Section 408(b)(2)(C) of FFDCA requires EPA to give special consideration to exposure of infants and children to the pesticide chemical residue in establishing a tolerance and to “ensure that there is a reasonable certainty that no harm will result to infants and children from aggregate exposure to the pesticide chemical residue. . . .” Consistent with FFDCA section 408(b)(2)(D), and the factors specified in FFDCA section 408(b)(2)(D), EPA has reviewed the available scientific data and other relevant information in support of this action. EPA has sufficient data to assess the hazards of and to make a determination on aggregate exposure for the petitioned-for tolerances for residues of metconazole. EPA's assessment of exposures and risks associated with establishing the tolerance follows. A. Toxicological Profile EPA has evaluated the available toxicity data and considered its validity, completeness, and reliability as well as the relationship of the results of the studies to human risk. EPA has also considered available information concerning the variability of the sensitivities of major identifiable subgroups of consumers, including infants and children. Acute oral and dermal toxicities to metconazole are moderate, while acute inhalation toxicity is low. Metconazole is a moderate eye irritant and a mild skin irritant. It is not a skin sensitizer. The liver is the primary target organ in the mouse, rat and dog following oral exposure to metconazole via subchronic or chronic exposure durations. Developmental studies in rats and rabbits show some evidence of developmental effects, but only at dose levels that are maternally toxic. Metconazole did not demonstrate the potential for neurotoxicity in the four species (mouse, rat, dog and rabbit) tested. Metconazole is considered nongenotoxic and liver tumors seen in chronic mouse study appear to have been formed via a mitogenic mode of action and therefore, metconazole is classified as “not likely to be carcinogenic to humans” at levels that do not cause mitogenesis. The chronic reference dose
(RfD)would be protective of mitogenesis/carcinogenesis. Specific information on the studies received and the nature of the adverse effects caused by metconazole as well as the no-observed-adverse-effect-level (NOAEL) and the lowest-observed-adverse-effect-level (LOAEL) from the toxicity studies can be found at *http://www.regulations.gov* under docket ID number EPA-HQ-OPP-2005-0016. B. Toxicological Endpoints For hazards that have a threshold below which there is no appreciable risk, a toxicological point of departure
(POD)is identified as the basis for derivation of reference values for risk assessment. The POD may be defined as the highest dose at which the NOAEL in the toxicology study identified as appropriate for use in risk assessment. However, if a NOAEL cannot be determined, the lowest dose at which adverse effects of concern are identified (the LOAEL) or a Benchmark Dose
(BMD)approach is sometimes used for risk assessment. Uncertainty/safety factors
(UFs)are used in conjunction with the POD to take into account uncertainties inherent in the extrapolation from laboratory animal data to humans and in the variations in sensitivity among members of the human population as well as other unknowns. Safety is assessed for acute and chronic dietary risks by comparing aggregate food and water exposure to the pesticide to the acute population adjusted dose
(aPAD)and chronic population adjusted dose (cPAD). The aPAD and cPAD are calculated by dividing the POD by all applicable UFs. Aggregate short-term, intermediate-term, and chronic-term risks are evaluated by comparing food, water, and residential exposure to the POD to ensure that the margin of exposure
(MOE)called for by the product of all applicable UFs is not exceeded. This latter value is referred to as the Level of Concern (LOC). For non-threshold risks, the Agency assumes that any amount of exposure will lead to some degree of risk. Thus, the Agency estimates risk in terms of the probability of an occurrence of the adverse effect greater than that expected in a lifetime. For more information on the general principles EPA uses in risk characterization and a complete description of the risk assessment process, see *http://www.epa.gov/pesticides/factsheets/riskassess.htm* . A summary of the toxicological endpoints for metconazole used for human risk assessment is discussed in Unit III.B. of the final rule published in the **Federal Register** of September 27, 2006 (71 FR 6383) (FRL-8085-2). C. Exposure Assessment 1. *Dietary exposure from food and feed uses* . In evaluating dietary exposure to metconazole, EPA considered exposure under the petitioned-for tolerances as well as all existing metconazole tolerances in (40 CFR 180.617). EPA assessed dietary exposures from metconazole in food as follows: i. *Acute exposure* . Quantitative acute dietary exposure and risk assessments are performed for a food-use pesticide, if a toxicological study has indicated the possibility of an effect of concern occurring as a result of a 1-day or single exposure. In estimating acute dietary exposure, EPA used food consumption information from the United States Department of Agriculture
(USDA)1994-1996 and 1998 Nationwide Continuing Surveys of Food Intake by Individuals (CSFII). As to residue levels in food, EPA assumed all foods for which there are tolerances were treated and contain tolerance-level residues. ii. *Chronic exposure* . In conducting the chronic dietary exposure assessment EPA used the food consumption data from the USDA 1994-1996 and 1998 CSFII. As to residue levels in food, EPA assumed all foods for which there are tolerances were treated and contain tolerance-level residues. iii. *Cancer* . Metconazole is classified as “not likely to be carcinogenic to humans” at levels that do not cause mitogenesis. The chronic RfD would be protective of mitogenesis/carcinogenesis and the chronic exposure assessment is appropriate for evaluating cancer risk. 2. *Dietary exposure from drinking water* . The Agency used screening level water exposure models in the dietary exposure analysis and risk assessment for metconazole in drinking water. These simulation models take into account data on the physical, chemical, and fate/transport characteristics of metconazole. Further information regarding EPA drinking water models used in pesticide exposure assessment can be found at *http://www.epa.gov/oppefed1/models/water/index.htm.* Based on the Pesticide Root Zone Model/Exposure Analysis Modeling System (PRZM/EXAMS) and Screening Concentration in Ground Water (SCI-GROW) models, the estimated environmental concentrations
(EECs)of metconazole for acute exposures are estimated to be 45.48 parts per billion
(ppb)for surface water and 0.384 ppb for ground water. The EECs for chronic exposures are estimated to be 31.25 ppb for surface water and 0.384 ppb for ground water. Modeled estimates of drinking water concentrations were directly entered into the dietary exposure model. For acute dietary risk assessment, the water concentration value of 45 ppb was used to assess the contribution to drinking water. For chronic dietary risk assessment, the water concentration of value 31 ppb was used to assess the contribution to drinking water. 3. *From non-dietary exposure* . The term “residential exposure” is used in this document to refer to non-occupational, non-dietary exposure (e.g., for lawn and garden pest control, indoor pest control, termiticides, and flea and tick control on pets). Metconazole is currently registered for the following residential non-dietary sites: Turf and ornamentals. Adult residential handlers may be exposed to metconazole as a result of applying metconazole to turf and ornamentals. Because dermal toxicity endpoints for the appropriate duration of exposure were not identified, only residential handler short-term inhalation exposures were assessed. Additionally, adults and adolescents may experience short-term and intermediate-term dermal post-application exposure from golfing and other activities on treated turf. Toddlers may experience short-term and intermediate-term dermal and incidental oral exposure from activities on treated turf. However, because dermal toxicity endpoints for the appropriate durations of exposure were not identified, and because inhalation exposure is considered to be insignificant for post-application exposures, only toddler incidental oral post-application exposures were assessed. 4. *Cumulative effects from substances with a common mechanism of toxicity* . Section 408(b)(2)(D)(v) of FFDCA requires that, when considering whether to establish, modify, or revoke a tolerance, the Agency consider “available information” concerning the cumulative effects of a particular pesticide's residues and “other substances that have a common mechanism of toxicity.” Metconazole is a member of the triazole-containing class of pesticides. Although conazoles act similarly in plants (fungi) by inhibiting ergosterol biosynthesis, there is not necessarily a relationship between their pesticidal activity and their mechanism of toxicity in mammals. Structural similarities do not constitute a common mechanism of toxicity. Evidence is needed to establish that the chemicals operate by the same, or essentially the same, sequence of major biochemical events. In conazoles, however, a variable pattern of toxicological responses is found. Some are hepatotoxic and hepatocarcinogenic in mice. Some induce thyroid tumors in rats. Some induce developmental, reproductive, and neurological effects in rodents. Furthermore, the conazoles produce a diverse range of biochemical events including altered cholesterol levels, stress responses, and altered DNA methylation. It is not clearly understood whether these biochemical events are directly connected to their toxicological outcomes. Thus, there is currently no evidence to indicate that conazoles share common mechanisms of toxicity and EPA is not following a cumulative risk approach based on a common mechanism of toxicity for the conazoles. For information regarding EPA's procedures for cumulating effects from substances found to have a common mechanism of toxicity, see EPA's website at *http://www.epa.gov/pesticides/cumulative* . Triazole-derived pesticides can form the common metabolite 1,2,4-triazole and two triazole conjugates (triazole alanine and triazole acetic acid). To support existing tolerances and to establish new tolerances for triazole-derivative pesticides, including metconazole, EPA conducted a human health risk assessment for exposure to 1,2,4-triazole, triazole alanine, and triazole acetic acid resulting from the use of all current and pending uses of any triazole-derived fungicide as of September 1, 2005. The risk assessment is a highly conservative, screening-level evaluation in terms of hazards associated with common metabolites (e.g., use of a maximum combination of uncertainty factors) and potential dietary and non-dietary exposures (i.e., high end estimates of both dietary and non-dietary exposures). In addition, the Agency retained the additional 10X FQPA safety factor for the protection of infants and children. The assessment includes evaluations of risks for various subgroups, including those comprised of infants and children. The Agency's September 1, 2005 risk assessment can be found in the propiconazole reregistration docket at *http://www.regulations.gov* (Docket ID EPA-HQ-OPP-2005-0497). An addendum to the risk assessment, *Dietary Exposure Assessments for the Common Triazole Metabolites 1,2,4-triazole, Triazolylalanine, Triazolylacetic Acid and Triazolylypyruvic Acid; Updated to Include New Uses of Fenbuconazole, Ipconazole, Metconazole, Tebuconazole, and Uniconazole* can be found at *http://www.regulations.gov* in docket ID EPA-HQ-OPP-2006-0855. D. Safety Factor for Infants and Children 1. *In general* . Section 408(b)(2)(c) of FFDCA provides that EPA shall apply an additional tenfold
(10X)margin of safety for infants and children in the case of threshold effects to account for prenatal and postnatal toxicity and the completeness of the database on toxicity and exposure unless EPA determines based on reliable data that a different margin of safety will be safe for infants and children. This additional margin of safety is commonly referred to as the FQPA safety factor (SF). In applying this provision, EPA either retains the default value of 10X, or uses a different additional safety factor when reliable data available to EPA support the choice of a different factor. 2. *Prenatal and postnatal sensitivity* . Acceptable developmental toxicity studies are available in the rat and rabbit as well as a 2-generation reproductive toxicity study in the rat. There is no evidence of susceptibility following *in utero* exposure in the rabbit. In the rat there is qualitative evidence of susceptibility, however the concern is low since the developmental effects are characterized as variations (not malformations), occur in the presence of maternal toxicity, the NOAELs are well defined, and the dose/endpoint is used for acute dietary risk assessment for the sensitive population. There is no evidence of increased susceptibility in the offspring based on the result of the 2-generation reproduction study. 3. *Conclusion.* EPA has determined that reliable data show the safety of infants and children would be adequately protected if the FQPA SF were reduced to 1X. That decision is based on the following findings: i. The toxicity database for metconazole is complete. ii. There was no evidence of neurotoxicity observed in the toxicology database and there is no need for a developmental neurotoxicity study or additional uncertainty factors to account for neurotoxicity. iii. There is no evidence of susceptibility following *in utero* exposure in the rabbit or in young rats in the 2-generation reproduction study. In the rat there is qualitative evidence of susceptibility, however the concern is low since the developmental effects are characterized as variations (not malformations), occur in the presence of maternal toxicity, the NOAELs are well defined, and the dose/endpoint is used for acute dietary risk assessment for the sensitive population. iv. Dietary exposure assessments were conducted using tolerance level residues and assumed 100% crop treated (CT). Therefore, the acute and chronic dietary, food only, exposure is considered an upper bound conservative estimate. Acute and chronic exposure estimates in this analysis are unlikely to underestimate actual exposure. v. The drinking water component of the dietary assessment utilizes water concentration values generated by model and associated modeling parameters which are designed to provide conservative, health protective, high-end estimates of water concentrations which will not likely be exceeded. vi. While there is potential for post application residential exposure, the Agency used the current conservative approaches for residential assessment. The Agency believes that the calculated risks represent conservative estimates of exposure because maximum application rates are used to define residue levels upon which the calculations are based. E. Aggregate Risks and Determination of Safety EPA determines whether acute and chronic pesticide exposures are safe by comparing aggregate exposure estimates to the aPAD and cPAD. The aPAD and cPAD represent the highest safe exposures, taking into account all appropriate SFs. EPA calculates the aPAD and cPAD by dividing the POD by all applicable UFs. For linear cancer risks, EPA calculates the probability of additional cancer cases given the estimated aggregate exposure. Short-term, intermediate-term, and chronic-term risks are evaluated by comparing the estimated aggregate food, water, and residential exposure to the POD to ensure that the MOE called for by the product of all applicable UFs is not exceeded. 1. *Acute risk* . Using the exposure assumptions discussed in this unit for acute exposure, the acute dietary exposure from food and water to metconazole will occupy 3% of the aPAD for the population group (females 13-49 years old) receiving the greatest exposure. 2. *Chronic risk* . Using the exposure assumptions described in this unit for chronic exposure, EPA has concluded that exposure to metconazole from food and water will utilize 4% of the cPAD for the U.S. population and 9% of the cPAD for the most highly exposed population group (infants less than 1-year old). 3. *Short-term risk* . Short-term risk takes into account residential exposure plus chronic exposure to food and water (considered to a background exposure level). Metconazole is currently registered for uses that could result in short-term residential exposure and the Agency has determined that it is appropriate to aggregate chronic food and water and short-term exposures for metconazole. Metconazole is currently registered for uses that could result in short-term residential exposure and the Agency has determined that it is appropriate to aggregate chronic food and water and short-term exposures for metconazole. Using the exposure assumptions described in this unit for short-term exposures, EPA has concluded that short-term aggregate MOEs from dietary exposure (food + drinking water) and non-occupational/residential handler exposure (inhalation) for adults are 2,700; the children's residential combined short-term MOE from treated turf is 810. The lowest MOE for residential handler short-term inhalation risks is 71,000. These MOEs are not of concern to the Agency, since they are greater than the level of concern MOE of 100. 4. *Intermediate-term risk* . Intermediate-term risk takes into account residential exposure plus chronic exposure to food and water (considered to a background exposure level). Metconazole is currently registered for uses that could result in intermediate-term residential exposure and the Agency has determined that it is appropriate to aggregate chronic food and water and intermediate-term exposures for metconazole. Using the exposure assumptions described in this unit for intermediate-term exposures, EPA has concluded that intermediate-term aggregate MOEs from dietary exposure (food + drinking water) and non-occupational/residential handler exposure (inhalation) for adults are 2,700; the children's residential combined short-term risk from treated turf are 1,000. These MOEs are not of concern to the Agency, since they are greater than the level of concern MOE of 100. 5. *Aggregate cancer risk for U.S. population* . Metconazole is classified as “not likely to be carcinogenic to humans“ at levels that do not cause mitogenesis. As explained in Unit lll.E2, the cPAD is protective of mitogenesis and because the chronic risk assessment for metconazole shows exposure to be below the cPAD, there is no cancer concern. 6. *Determination of safety* . Based on these risk assessments, EPA concludes that there is a reasonable certainty that no harm will result to the general population, or to infants and children from aggregate exposure to metconazole residues. IV. Other Considerations A. Analytical Enforcement Methodology The following adequate enforcement methodologies are available to enforce the tolerance expression: 1. A liquid chromatography/mass spectrometry method (LC/MS) (method D0508) along with multi-residue methods serving as a confirmatory method are adequate to enforce tolerances for residues in small grain, soybean, and sugarbeet agricultural and processed commodities. 2. A gas chromatography/nitrogen-phosphorus detection method (GC/NPD) (method RM-41C-1-1) is adequate to enforce tolerances for residues in stone fruit, tree nuts, and peanut commodities. 3. A German multi-residue method (method DFG S19) is adequate for enforcing tolerances for residues in livestock commodities. The methods may be requested from: Chief, Analytical Chemistry Branch, Environmental Science Center, 701 Mapes Rd., Ft. Meade, MD 20755-5350; telephone number:
(410)305-2905; e-mail address: *residuemethods@epa.gov* . B. International Residue Limits There are currently no Codex, Canadian, or Mexican MRLs established for metconazole. C. Response to Comments There were no comments received in response to the notice of filing. D. Revisions to Petitioned-For Tolerances Based upon review of the data supporting the petition, EPA determined that the proposed tolerances should be revised as follows: Almond, hulls decreased from 5.00 ppm to 4.0 ppm; barley, grain increased from 2.0 ppm to 2.5 ppm; beet, sugar, dried pulp reduced from 1.9 ppm to 0.70 ppm; beet, sugar, molasses reduced from 0.2 ppm to 0.08 ppm; beet, sugar, roots reduced from 0.1 ppm to 0.07 ppm; nut, tree, group 14 increased from 0.02 to 0.04 ppm; oat, grain increased from 0.1 ppm to 1.0 ppm; peanut increased from 0.02 ppm to 0.04 ppm; pistachio increased from 0.02 ppm to 0.04 ppm; soybean, hulls decreased from 0.2 ppm to 0.08 ppm; soybean, seed reduced from 0.1 ppm to 0.05 ppm; and wheat, milled byproducts reduced from 1.0 ppm to 0.20 ppm. The wheat, aspirated grain fraction and soybean, aspirated grain fraction proposals at 10.0 ppm and 1.0 ppm, respectively, should be expressed as grain, aspirated grain fractions and revised to 7.0 ppm. EPA revised the tolerance levels based on analysis of the residue field trial data using the Agency's Tolerance Spreadsheet in accordance with the Agency's *Guidance for Setting Pesticide Tolerances Based on Field Trial Data* Standard Operating Procedure (SOP). No tolerances are needed for beet sugar and soybean meal since metconazole does not increase in these commodities on processing. The tolerance on sugar beet root covers sugar. No tolerance is needed for sugar beet tops since this commodity is no longer a significant feed item. Separate tolerances are being established for meat byproducts of cattle, goat, horse, and sheep at 0.04 ppm based on a cattle feeding study in which dairy cattle were fed metconazole at levels corresponding to 1.3x, 3.9x, and 12x, respectively, the dietary burden for beef cattle and 0.54x, 1.7x, and 5.2x, respectively, the dietary burden for dairy cattle. In liver, residues of *cis* and *trans* -metconazole were <0.02-0.021 ppm and <0.02 ppm, respectively, in samples from the high-dose group and below the LOQ (both isomers) in samples from the low-dose and mid-dose groups. Maximum total metconazole residues (sum of *cis* and *trans* isomers) in liver were 0.041 ppm from the high-dose group. Because quantifiable residues of *cis* -metconazole were observed in liver (0.021 ppm) at the highest dosing level, tolerances are needed for meat byproducts at the limit of quantitation of the enforcement method (0.04 ppm). V. Conclusion Therefore, the tolerances are established for residues of metconazole, 5-[(4-chlorophenyl)-methyl]-2,2-dimethyl-1-(1H-1,2,4-triazol-1-ylmethyl)cyclopentanol, in or on almond, hulls at 4.0 ppm; barley, grain at 2.5 ppm; barley, hay at 7.0 ppm; barley, straw at 7.0 ppm; beet, sugar, dried pulp at 0.70 ppm; beet, sugar, molasses at 0.08 ppm; beet, sugar, roots at 0.07 ppm; cattle, meat byproducts at 0.04 ppm; fruit, stone, group 12 at 0.20 ppm; goat, meat byproducts at 0.04 ppm; grain, aspirated grain fractions at 7.0 ppm; horse, meat byproducts at 0.04 ppm; nut, tree, group 14 at 0.04 ppm; oat, grain at 1.0 ppm; oat, hay at 17 ppm; oat, straw at 6.0 ppm; peanut at 0.04 ppm; peanut, refined oil at 0.05 ppm; pistachio at 0.04 ppm; rye, grain at 0.25 ppm; rye, straw at 14 ppm; sheep, meat byproducts at 0.04 ppm; soybean, forage at 3.0 ppm; soybean, hay at 6.0 ppm; soybean, hulls at 0.08 ppm; soybean, seed at 0.05 ppm; wheat, grain at 0.15 ppm; wheat, hay at 16 ppm; wheat, milled byproducts at 0.20 ppm; wheat, straw at 18 ppm. VI. Statutory and Executive Order Reviews This final rule establishes tolerances under section 408(d) of FFDCA in response to a petition submitted to the Agency. The Office of Management and Budget
(OMB)has exempted these types of actions from review under Executive Order 12866, entitled *Regulatory Planning and Review* (58 FR 51735, October 4, 1993). Because this rule has been exempted from review under Executive Order 12866, this rule is not subject to Executive Order 13211, *Actions Concerning Regulations That Significantly Affect Energy Supply, Distribution, or Use* (66 FR 28355, May 22, 2001) or Executive Order 13045, entitled *Protection of Children from Environmental Health Risks and Safety Risks* (62 FR 19885, April 23, 1997). This final rule does not contain any information collections subject to OMB approval under the Paperwork Reduction Act (PRA), 44 U.S.C. 3501 *et seq* ., nor does it require any special considerations under Executive Order 12898, entitled *Federal Actions to Address Environmental Justice in Minority Populations and Low-Income Populations* (59 FR 7629, February 16, 1994). Since tolerances and exemptions that are established on the basis of a petition under section 408(d) of FFDCA, such as the tolerance in this final rule, do not require the issuance of a proposed rule, the requirements of the Regulatory Flexibility Act
(RFA)(5 U.S.C. 601 *et seq* .) do not apply. This final rule directly regulates growers, food processors, food handlers, and food retailers, not States or tribes, nor does this action alter the relationships or distribution of power and responsibilities established by Congress in the preemption provisions of section 408(n)(4) of FFDCA. As such, the Agency has determined that this action will not have a substantial direct effect on States or tribal governments, on the relationship between the national government and the States or tribal governments, or on the distribution of power and responsibilities among the various levels of government or between the Federal Government and Indian tribes. Thus, the Agency has determined that Executive Order 13132, entitled *Federalism* (64 FR 43255, August 10, 1999) and Executive Order 13175, entitled *Consultation and Coordination with Indian Tribal Governments* (65 FR 67249, November 9, 2000) do not apply to this rule. In addition, This rule does not impose any enforceable duty or contain any unfunded mandate as described under Title II of the Unfunded Mandates Reform Act of 1995
(UMRA)(Public Law 104-4). This action does not involve any technical standards that would require Agency consideration of voluntary consensus standards pursuant to section 12(d) of the National Technology Transfer and Advancement Act of 1995 (NTTAA), Public Law 104-113, section 12(d) (15 U.S.C. 272 note). VII. Congressional Review Act The Congressional Review Act, 5 U.S.C. 801 *et seq* ., generally provides that before a rule may take effect, the agency promulgating the rule must submit a rule report to each House of the Congress and to the Comptroller General of the United States. EPA will submit a report containing this rule and other required information to the U.S. Senate, the U.S. House of Representatives, and the Comptroller General of the United States prior to publication of this final rule in the **Federal Register** . This final rule is not a “major rule” as defined by 5 U.S.C. 804(2). List of Subjects in 40 CFR Part 180 Environmental protection, Administrative practice and procedure, Agricultural commodities, Pesticides and pests, Reporting and recordkeeping requirements. Dated: April 15, 2008. Daniel Kenny, Acting Director, Registration Division, Office of Pesticide Programs. Therefore, 40 CFR chapter I is amended as follows: PART 180—[AMENDED] 1. The authority citation for part 180 continues to read as follows: Authority: 21 U.S.C. 321(q), 346a and 371. 2. Section 180.617 is amended by alphabetically adding the following commodities to the table in paragraph
(a)and by removing and reserving paragraph
(b)with heading to read as follows: 180.617 Metconazole; tolerances for residues.
(a)* * * Commodity Parts per million Almond, hulls 4.0 * * * * * Barley, grain 2.5 Barley, hay 7.0 Barley, straw 7.0 Beet, sugar, dried pulp 0.70 Beet, sugar, molasses 0.08 Beet, sugar, roots 0.07 Cattle, meat byproducts 0.04 Fruit, stone, group 12 0.20 Goat, meat byproducts 0.04 Grain, aspirated grain fractions 7.0 Horse, meat byproducts 0.04 Nut, tree, group 14 0.04 Oat, grain 1.0 Oat, hay 17 Oat, straw 6.0 Peanut 0.04 Peanut, refined oil 0.05 Pistachio 0.04 Rye, grain 0.25 Rye, straw 14 Sheep, meat byproducts 0.04 Soybean, forage 3.0 Soybean, hay 6.0 Soybean, hulls 0.08 Soybean, seed 0.05 Wheat, grain 0.15 Wheat, hay 16 Wheat, milled byproducts 0.20 Wheat, straw 18
(b)*Section 18 emergency exemption* . [Reserved] [FR Doc. E8-8971 Filed 4-25-08; 8:45 am] BILLING CODE 6560-50-S ENVIRONMENTAL PROTECTION AGENCY 40 CFR Part 300 [EPA-HQ-SFUND-1990-0011; FRL-8558-5] National Oil and Hazardous Substances Pollution Contingency Plan National Priorities List AGENCY: Environmental Protection Agency. ACTION: Notice of partial deletion of the Seneca Army Depot Activity Superfund Site from the National Priorities List. SUMMARY: The United States Environmental Protection Agency
(EPA)Region 2 announces the deletion from the National Priorities List
(NPL)of the following two specific parcels of real property located at the Seneca Army Depot Activity
(SEDA)Superfund Site (Site), Romulus, New York: Real Estate Parcel 1, except for a portion of this parcel known as SEAD-24; and the entirety of Real Estate Parcel 2. The NPL, promulgated pursuant to section 105 of the Comprehensive Environmental Response, Compensation, and Liability Act (CERCLA) of 1980, as amended, is found at Appendix B of 40 CFR part 300, which is an appendix to the National Oil and Hazardous Substances Pollution Contingency Plan (NCP). This partial deletion of SEDA parcels is done in accordance with 40 CFR 300.425(e) and the Notice of Policy Change: Partial Deletion of Sites Listed on the National Priorities List, 60 FR 55466 (Nov. 1, 1996). This deletion pertains to all media (surface soils, subsurface soils, structures, surface water, and ground water) within Parcel 1, excluding the SEAD-24 portion of Parcel 1, and Parcel 2. Parcel 1, also known as the Empire Biofuels Redevelopment area, is located midway on the western edge of SEDA. Most of this Parcel did not require remedial investigations under CERCLA. The two areas within Parcel 1 that were investigated under CERCLA are known as SEAD-58 and SEAD-24. SEAD-58 includes two debris disposal areas that have been found to require no active remediation under CERCLA. SEAD-24 is a two-acre area which underwent a soil removal action in 2004 and is awaiting a determination by EPA that all appropriate response actions have been implemented. SEAD-24 is not included in this deletion and will remain on the NPL. Parcel 2, also known as the Seneca County Public Safety Building and Jail area, is located along the eastern perimeter of SEDA in the southeast quadrant. The parcel encompasses two sub-parcel areas designated as SEAD-50 and SEAD-54, both of which have been remediated. Subsequent sampling of these two areas confirmed that all appropriate CERCLA response actions were performed. However, SEAD-50 and 54 are subject to institutional controls in the form of deed restrictions which prohibit residential use and use of the groundwater as they are part of the encompassing Planned Industrial Development area. The rest of SEDA will remain on the NPL, and response activities will continue at the remaining areas determined to be in need of response actions. The EPA and the State of New York, through the New York State Department of Environmental Conservation, have determined that all appropriate response actions under CERCLA have been completed at the parcels proposed for deletion. However, the deletion of these parcels does not preclude future actions under Superfund. DATES: This rule will be effective April 28, 2008. ADDRESSES: EPA has established a docket for this action under Docket Identification No. EPA-HQ-SFUND-1990-0011. All documents in the docket are listed on the *http://www.regulations.gov* Web site. Although listed in the index, some information is not publicly available, i.e., confidential business information or other information whose disclosure is restricted by statute. Certain other material, such as copyrighted material, is not placed on the Internet and will be publicly available only in hard copy form. Publicly available docket materials are available either electronically through *http://www.regulations.gov* or in hard copy at the site information repositories. Locations, contacts, phone numbers and viewing hours are: Regional Repository, U.S. EPA Region 2 Records Center, 290 Broadway, 18th Floor, New York, NY 10007-1866, Hours: 9 a.m. to 5 p.m.—Monday through Friday.
(212)637-4308. Local Site Repository, Seneca Army Depot Activity, 5786 State Route 96, Building 123, Romulus, NY 14541, Hours: 9 a.m. to 3:30 p.m.—Monday through Thursday.
(607)869-1494. FOR FURTHER INFORMATION CONTACT: Mr. Julio F. Vazquez, Remedial Project Manager, U.S. EPA Region 2, 290 Broadway, 18th Floor, New York, NY 10007-1866,
(212)637-4323. SUPPLEMENTARY INFORMATION: The parcels to be deleted from the NPL are Parcel 1, excluding SEAD-24, and the entirety of Parcel 2 of SEDA. A notice of intent for partial deletion for this site was published in the **Federal Register** on September 11, 2007. The closing date for comments on the notice of intent for partial deletion was October 20, 2007. Eleven public comments were received, and all the comments relate to the construction of an ethanol plant on Parcel 1. This issue is not related to our finding that Parcel 1, excluding SEAD-24, and Parcel 2 do not present any threat to human health or the environment. A responsiveness summary was prepared and placed in both the docket, EPA-HQ-SFUND-1990-0011, on *http://www.regulations.gov* and in the local repositories listed above. EPA identifies sites that may present a significant risk to public health, welfare and the environment. The NPL is a list of releases or threatened releases which EPA has determined to be a priority. Deletion of a portion of a site from the NPL does not preclude further remedial action. If a significant release occurs at a site, or any portion thereof, which has been deleted from the NPL, the deleted portions of the site may be restored to the NPL without application of the Hazard Ranking System. Deletion of any portion of a site from the NPL does not affect responsible party liability for further remedial actions, in the unlikely event that future conditions warrant such actions. Responsiveness Summary Introduction A Notice of Intent of Partial Deletion for the Seneca Army Depot Activity
(SEDA)Superfund Site was published in the **Federal Register** on September 11, 2007 (72 FR 51758-51762). The publication of this notice was intended to inform the public that EPA planned to delete two specific parcels from the National Priorities List: Real Estate Parcel 1, except for a portion of that parcel known as SEAD-24; and the entirety of Real Estate Parcel 2. The notice also provided a 30-day public comment period on the proposed partial deletion. The closing date for comments on the Notice of Intent to Partially Delete was October 11, 2007. Eleven written comments were received (these comments are available in the Information Repositories); therefore EPA has prepared this Responsiveness Summary. In addition, all public comments were considered in EPA's final decision to delete these parcels (as identified above) of the Site from the NPL. Responsiveness Summary This Responsiveness Summary has been prepared to provide responses to comments submitted to EPA during the 30-day public comment period regarding the Notice of Intent to Partially Delete (72 FR 51762) a portion of Real Estate Parcel 1 and Real Estate Parcel 2 of the SEDA. The original comments are summarized below and available at *http://www.regulations.gov* , Docket ID No. EPA-HQ-SFUND-1990-0001, with the support materials under document type “public submissions” and at the information repositories at the following addresses: U.S. EPA Region 2 Records Center, 290 Broadway—18th Floor, New York, NY 10007-1866, Hours: 9 a.m. to 5 p.m.—Monday through Friday,
(212)637-4308; and Seneca Army Depot Activity, 5786 State Route 96, Building 123, Romulus, NY 14541, Hours: 9 a.m. to 3:30 p.m.—Monday through Thursday,
(607)869-1494. *Summary of Comment from Mary Anne Kowalski:* The commenter is opposed to the deletion of Parcel 1 because this land is proposed to be used for an ethanol plant that is proceeding without an environmental impact statement, expressing the view that without an environmental impact statement the residents of Seneca County have no way of determining the impact of this construction on the hazardous materials already there. This deletion action would remove another impediment to construction. *Response:* In the summer of 2003, EPA concurred with the Finding of Suitability to Transfer
(FOST)for the Conservation/Recreation Area. This Area included Parcel 1, except for SEAD-58 and SEAD-24. In 2006, EPA determined that no action under CERCLA was necessary for SEAD-58. Therefore, EPA's determination is that soils in the Parcel 1 area proposed for deletion do not present an unacceptable threat to human health or the environment. Note that a delisting action has no significant effect upon redevelopment activities. An ethanol plant may or may not be constructed regardless of whether the parcel remains listed on the NPL. *Summary of Comment from Sandra L. Dranias:* The commenter expressed concern regarding the potential health hazards that will be unleashed by the premature disturbance of these heavily contaminated soils in the parcels being proposed for deletion. Documents list hazardous materials removed from the site listed as SEAD-24. SEAD-24 is located directly nearby the proposed location of the ethanol refinery. None of the soil surrounding SEAD-24 was ever tested to see if any of these chemicals leached beyond the borders drawn by the Government. *Response:* SEAD-24, the abandoned powder burning pit, underwent a time-critical removal action between 2004 and 2006. EPA has not made its final determination on the ultimate adequacy of this action. Therefore, this area is retained by the Army until a final determination is made whether this area no longer presents a significant threat to human health or the environment. SEAD-24 is not the subject of this de-listing from the NPL. *Summary of Comment from Tom and Nancy Hooser:* The commenters noted that, if their information is correct, this deletion means that no additional cleanup is necessary at the parcel where an ethanol plant is to be built. We have been provided no environmental impact study, and the prospect of what could happen down the line is enormous. The parcel in question needs to be thoroughly cleaned up before anything as hazardous as an ethanol plant is built in our backyards. *Response:* It is correct that it has been determined that no additional action is deemed necessary at both Parcel 1, except SEAD-24 (which is not being deleted) and Parcel 2. They do not present an unacceptable threat to human health or the environment. Parcel 1, SEAD-58, after remedial investigation activities, was found to require no active remediation under CERCLA. Parcel 2, including SEAD-50 and SEAD-54, underwent remediation. *Summary of Comment from Bobbi Clifford:* The commenter pointed out that 8,300 acres were identified for conservation/recreation uses according to the Preferred Land Use Plan/Seneca Army Depot Reuse Plan. On page 21-7, under 9(c), Environmental: the State criteria require that a “proposed site not contain any wetlands.” In the February, 1998 report of the Administrative Final Environmental Impact Statement, the SEDA Wetlands, Fish and Wildlife Plan identifies “87 distinct wetlands on the depot lands.” In the Environmental Assessment Form of 11/06 for the ethanol/biomass project, Malcolm Pirnie identified the following: “sixteen wetlands and eight streams were delineated for the ethanol/biomass project site, with the main site having eleven wetlands and two streams. Within the main site, a large wetland system is approximately 60 acres in size.” This comment implies that redevelopment of the property proposed for deletion may negatively impact wetlands. Additionally, the commenter pointed out that during the 1950s and 1960s, classified metallic parts were buried at the Miscellaneous Components burial Site. Because the documentation of the disposal is considered classified by the Army, the exact nature of the buried material has not been disclosed. Results of site investigations indicate that previous activities may have adversely impacted soil and groundwater. The commenter implies that contamination may exist at the parcel proposed for deletion could pose a threat to human health and the environment. *Response:* In 2003, EPA concurred with the Finding of Suitability to Transfer for the Conservation/Recreation Area. This document served as the basis for the transfer of the 8,300 acre parcel. EPA concurred with this transfer because it had been determined that no further remediation was warranted at this parcel, and none of the investigation performed at this area identified contaminants that would present an unacceptable risk under any land use scenario. The wetlands issue is not related to this de-listing action. EPA's role to oversee the suitability of the property to be de-listed does not include approving any specific redevelopment. There are many other areas within SEDA that are undergoing investigation and other CERCLA-related efforts, including the Miscellaneous Components Burial Site. These areas are under the control of the Army and will remain on the NPL until all appropriate response actions are implemented or it is determined that the areas pose no significant threat to public health or the environment. *Summary of Comment from John Ghidiu:* This commenter objected to the delisting because it was his understanding that solid waste and incinerator ash were disposed of intermittently for 30 years between 1941 and 1979, that radioactive materials were stored in several of the igloos on the south end of SEDA, and herbicides and pesticides were stored there as well. Demilitarization of munitions had also been conducted for forty years by open burning of fuses, projectiles, explosives and propellants directly upon the ground surface. Burial of laboratory wastes occurred between 1940 and 1980 at the Radioactive Waste Burial Sites and the Pitchblende Storage Igloos. *Response:* The areas to be de-listed are not included in any of the areas of concern identified by the commenter. Since 1984, when SEDA was proposed to be included on the NPL, EPA, the Army and the State of New York have been working on various areas of concern including the Ash Landfill (SEAD-03, 06, 08, 14 and 15), the Pitchblende Ore Storage (SEAD-48), and the Radioactive Burial Sites (SEAD-12). Although some of the work is still in progress at these Army-retained areas, the parcels proposed to be de-listed from the NPL are areas where either all appropriate response actions have been implemented or there is no significant threat to public health or the environment. List of Subjects in 40 CFR Part 300 Environmental protection, Air pollution control, Chemicals, Hazardous waste, Hazardous substances, Intergovernmental relations, Penalties, Reporting and recordkeeping requirements, Superfund, Water pollution control, Water supply. Dated: March 14, 2008. Alan J. Steinberg, Regional Administrator, Region 2. For the reasons set forth in the preamble, 40 part 300 is amended as follows. PART 300—[AMENDED] 1. The authority citation for part 300 continues to read as follows: Authority: 33 U.S.C. 1321(c)(2); 42 U.S.C. 9601-9657; E.O. 12777, 56 FR 54757, 3 CFR 1991 Comp., p. 351; E.O. 12580, 52 FR 2923, 3 CFR 1987 Comp., p. 193. Appendix B—[Amended] 2. Table 2 of appendix B to part 300 is amended by revising the entry under New York for “Seneca Army Depot” to read as follows: Appendix B to Part 300—National Priorities List Table 2.—Federal Facilities Section St Site name City/County Notes a * * * * * * * NY Seneca Army Depot Romulus P * * * * * * *
(a)* * * P = Sites with partial deletion(s). [FR Doc. E8-9077 Filed 4-25-08; 8:45 am] BILLING CODE 6560-50-P DEPARTMENT OF COMMERCE National Oceanic and Atmospheric Administration 50 CFR Part 648 [Docket No. 071128763-8490-02] RIN 0648-AW33 Magnuson-Stevens Fishery Conservation and Management Act Provisions; Fisheries of the Northeastern United States; Monkfish Fishery; Framework Adjustment 5 to the Monkfish Fishery Management Plan AGENCY: National Marine Fisheries Service (NMFS), National Oceanic and Atmospheric Administration (NOAA), Commerce. ACTION: Final rule. SUMMARY: NMFS approves and implements new management measures for the monkfish fishery recommended in Framework Adjustment 5 (Framework 5) to the Monkfish Fishery Management Plan (FMP), which has been submitted jointly by the New England (NEFMC) and Mid-Atlantic Fishery Management Councils (Councils). This action approves and implements revised biological reference points in the FMP to be consistent with the recommendations resulting from the most recent stock assessment for this fishery (Northeast Data Poor Stocks Working Group (DPWG, July 2007)), and approves and implements revised management measures to ensure that the monkfish management program succeeds in keeping landings within the target total allowable catch
(TAC)levels. DATES: This rule is effective May 1, 2008. ADDRESSES: Copies of the Environmental Assessment (EA), including the Regulatory Impact Review
(RIR)and Initial Regulatory Flexibility Analysis (IRFA), prepared for Framework 5 are available upon request from Paul Howard, Executive Director, NEFMC, 50 Water Street, Newburyport, MA, 01950. The document is also available online at www.nefmc.org. NMFS prepared a Final Regulatory Flexibility Analysis (FRFA), which is contained in the classification section of this rule. The FRFA consists of the IRFA, public comments and responses contained in this final rule, and a summary of impacts and alternatives contained in this final rule. The small entity compliance guide is available from Patricia A. Kurkul, Regional Administrator, Northeast Regional Office, National Marine Fisheries Service, One Blackburn Drive, Gloucester, MA 01930 2298, and on the Northeast Regional Office's website at *http://www.nero.noaa.gov* . FOR FURTHER INFORMATION CONTACT: Tobey Curtis, Fishery Policy Analyst, e-mail *Tobey.Curtis@noaa.gov* , phone
(978)281-9273, fax
(978)281-9135. SUPPLEMENTARY INFORMATION: Background The monkfish fishery is jointly managed by the Councils, with the NEFMC having the administrative lead. The fishery extends from Maine to North Carolina, and is divided into two management units: The Northern Fishery Management Area
(NFMA)and the Southern Fishery Management Area (SFMA). In July 2007, the DPWG completed and accepted a new monkfish assessment. The results of this assessment indicate that neither stock is overfished, overfishing is no longer occurring, and both stocks are rebuilt based on a new modeling approach and newly recommended biological reference points. In addition to the fact that this assessment was the first to use a new analytical model, the July 2007 assessment report emphasizes the high degree of uncertainty in the analyses due to the dependence on assumptions about natural mortality, growth rates, and other model inputs. The report concluded that the data-poor nature of this species and the significant uncertainty in assessing the stocks should be considered when developing management measures. Framework 5 implements the revised biological reference points recommended by the DPWG and makes other modifications to the regulations to ensure that the management program succeeds in keeping landings within the target TACs implemented in Framework Adjustment 4 (72 FR 53942; September 21, 2007). The management measures contained in Framework 5 are described in detail in the following paragraphs. Framework 5 Management Measures 1. Revision to Biological Reference Points This action revises the biological reference points contained in the FMP to be consistent with those recommended in the July 2007 assessment report. In that report, the DPWG recommended that B target for both management areas be set equivalent to the average of the total biomass from 1980 through 2006. Therefore, this final rule establishes a B target of 92,200 mt for the NFMA and 122,500 mt for the SFMA. In addition, the DPWG recommended that B threshold for both management areas be set equivalent to the lowest value of total biomass from 1980 through 2006. As a result, this final rule establishes a B threshold of 65,200 mt for the NFMA and 96,400 mt for the SFMA. The most recent estimate of biomass for each management area (B 2006 ) is 118,700 mt for the NFMA and 135,500 mt for the SFMA. Therefore, based upon the revised biological reference points being implemented in this final rule, both monkfish stocks are no longer overfished (B 2006 above B threshold ), and are rebuilt (B 2006 above B target ). 2. Reduction in Carryover Days-at-Sea
(DAS)This action reduces the number of unused monkfish DAS that a limited access monkfish vessel is allowed to carry over from one fishing year into the next from 10 to 4 DAS. Carryover DAS are intended to enhance safety at sea by allowing a vessel, at the end of a fishing year, to avoid the predicament of using or losing DAS in the event of bad weather or mechanical problems. However, Framework 5 brought into question whether 10 carryover DAS were really needed, especially since the use of carryover DAS contributed to a substantial overage (60 percent) in the target TAC for the SFMA during FY 2006, when vessels in this area were only allocated 12 DAS for the fishing year. During that fishing year, carryover DAS represented over an 80-percent increase above a limited access monkfish vessel's base allocation of monkfish DAS. As a result, NMFS approved and the Councils recommended a reduction in carryover DAS because it better reflects an amount that is commensurate to a vessel's base DAS allocation, thereby helping to ensure that the target TACs are not exceeded, while still providing members of the fishing industry with some carryover DAS to enhance safety at the end of the fishing year. Since most monkfish trips are less than four days in duration, the reduction to 4 carryover DAS is not expected to undermine the promotion of safe fishing practices at the end of a fishing year. This final rule implements the Councils' recommendation. 3. Revision to DAS Accounting Provision for Gillnet Vessels This action changes the manner in which DAS are counted for monkfish gillnet vessels. The FMP currently states that monkfish gillnet vessels are charged actual time fished on trips less than 3 hours or greater than 15 hours in duration, but are charged a minimum of 15 hours for trips from 3 to 15 hours in duration. The original intent of this regulation was to adjust gillnet effort to be more equivalent to trawl effort, but allow vessels that run into bad weather or experience mechanical difficulties at the beginning of a trip to return to port and only be charged actual time at sea (i.e., trips less than 3 hours in duration). However, as monkfish DAS have been reduced in recent years, some vessels have begun to exploit this 3-hour window and use it to catch and land monkfish. As a result, an allocation of 23 monkfish DAS, for example, would normally allow a vessel to take approximately 36 15-hour trips. If that vessel exploited the 3-hour provision, the number of potential trips could increase to as many as 184. It appears that only a few vessels are currently exploiting this provision, but there is potential for increased usage, which then increases the probability that the target TACs will be exceeded. As a result, the Councils recommended that the 3-hour provision be eliminated, requiring all monkfish gillnet trips of less than 15 hours in duration to be charged 15 hours. Although removal of this provision reduces some flexibility for gillnet vessels, NMFS approved this recommendation because of the potential negative impacts on the monkfish resource from exploitation of the status quo alternative outweigh the original flexibility and safety intentions of this infrequently invoked provision. Under this action, vessels with VMS will still have the ability to return to port, prior to crossing the VMS demarcation line at the start of a trip, if they experience bad weather or mechanical issues and not be charged DAS. This final rule implements the Councils' recommendation. This action also adds a sentence to the section of the regulations concerning the monkfish gillnet accounting rules, found at § 648.92 (b)(8)(v), to clarify that a monkfish gillnet vessel fishing under a joint monkfish and NE multispecies DAS, that is declared as a trip gillnet vessel under the NE Multispecies FMP, must remove its gillnet gear from the water prior to calling out of the DAS program. The language contained in this section was recently clarified in a letter from the Regional Administrator to limited access monkfish permit holders, dated August 13, 2007. 4. Revision to the Incidental Catch Limit in the SFMA This action revises the monkfish incidental catch limit applicable to large-mesh vessels fishing in the Southern New England Regulated Mesh Area (SNE RMA), as defined under the Northeast
(NE)multispecies regulations, east of 72°30′ W long., but not under a monkfish, NE multispecies, or scallop DAS, or vessels fishing under a Skate Bait Letter of Authorization
(LOA)in the SNE RMA east of 74°00′ W long., to be 5 percent (tail weight) of the total weight of fish on board, not to exceed 50 lb (23 kg) tail weight per day, up to 150 lb (68 kg) tail weight per trip. The Councils recommended this change to the incidental catch limit in response to reports that vessels fishing for skate as bait in the SNE RMA, using mesh larger than the multispecies minimum mesh size (i.e., large mesh), are targeting monkfish using the existing incidental catch limit; which is 5 percent (tail weight) of the total weight of fish on board with no limit on the amount of monkfish that the vessel can land. This behavior could undermine the FMP's ability to prevent overfishing. The landings cap recommended by the Councils in this action is equivalent to the incidental catch limit applicable to vessels not fishing under a DAS in the SNE RMA with small-mesh, hook gear, or dredge gear. This final rule implements the Councils' recommendation. 5. Revision to Monkfish LOA Requirement This action eliminates the requirement to obtain a Monkfish LOA to fish under the less restrictive management measures of the NFMA for vessels using a vessel monitoring system (VMS). Monkfish vessels using the interactive voice response
(IVR)call-in system, however, will still be required to obtain a Monkfish LOA. The Councils recommended this action because requiring an LOA was determined to be burdensome and unnecessary, given that VMS screens were recently revised to enable limited access monkfish vessels to declare the management area in which they are fishing when declaring a monkfish DAS. In addition, the VMS system enables NMFS to monitor where these vessels are fishing. Conversely, although vessels using the IVR call-in system can now declare the management area in which they are fishing through that system, NMFS cannot monitor where these vessels are fishing in the same manner as VMS vessels. In this final rule, NMFS approves the Councils recommendation that the Monkfish LOA requirement be eliminated for VMS vessels, but retained for vessels using the IVR call-in system. Technical Corrections to Monkfish FMP Regulations Two corrections to the regulations implementing the Monkfish FMP are included in this final rule. The first correction removes a duplicate paragraph concerning the impact of leasing NE multispecies DAS on a vessel's monkfish DAS allocation (§ 648.92(b)(2)(iii)). This paragraph should have been removed in the final rule implementing Framework 4. The second set of corrections corrects the cross-references to the regulations implementing the Atlantic Sea Scallop FMP concerning accrual of DAS and the Good Samaritan credit found at § 648.92(b)(3) and (4). It appears that the final rule implementing Amendment 10 to the Atlantic Sea Scallop FMP (69 FR 35215; June 23, 2004) revised § 648.53, thereby inadvertently impacting these cross-references in the monkfish regulations. Comments and Responses The public comment period on the proposed rule ended on March 25, 2008, with three comments received. *Comment 1* : The commenter suggested that Framework 5 would allow overfishing of monkfish to continue, and more restrictive measures should be implemented. *Response* : There is no scientific basis for the commenter's statements, as monkfish are not currently subject to overfishing, nor in an overfished condition based on the best scientific information available. Measures more restrictive than those implemented under prior actions in the monkfish fishery and in this final rule are not justified at this time. *Comment 2* : The commenter supported some Framework 5 measures, but disagreed with others. Specifically, the commenter supported the measures to revise the biological reference points, eliminate the 3-hour provision for gillnet vessels, revise the incidental catch limits, and revise the LOA requirements in the NFMA. The commenter disagreed with the measure to reduce carryover DAS from 10 to 4. The commenter stated that such restrictions were no longer justified given the positive change in monkfish stock status. *Response* : The reduction of carryover DAS would, to some extent, reduce flexibility for industry members that were unable to use all of their allotted DAS due to poor weather or mechanical problems. However, the use of carryover DAS contributed to a substantial overage (60 percent) in the target TAC for the SFMA during FY 2006, when vessels in this area were only allocated 12 DAS for the fishing year. During that fishing year, carryover DAS represented over an 80-percent increase above a limited access monkfish vessel's base allocation of monkfish DAS. Therefore, NMFS approved the Councils' recommended reduction in carryover DAS because it better reflects an amount of DAS that is commensurate to a vessel's annual DAS allocation, thereby helping to ensure that the target TACs are not exceeded, without compromising the safety benefits of being able to defer some fishing days to the next fishing year. Additionally, a significant amount of uncertainty remains in the results of the DPWG stock assessment. Changes to monkfish management strategies should, therefore, be precautionary, and significant liberalization of measures are not justified at this time. *Comment 3* : The commenter was concerned about the dramatic change in monkfish stock status resulting from the revised biological reference points. The commenter was supportive, however, of all the measures included in Framework 5, since they are intended to keep monkfish landings within the target TACs. *Response* : NMFS is confident that the revised biological reference points proposed by the DPWG represent the best available science on monkfish stock status. The measures included in Framework 5, however, remain appropriately precautionary due to some level of uncertainty in the assessment. Classification The Administrator, Northeast Region, NMFS, determined that Framework 5 is necessary for the conservation and management of the monkfish fishery and that it is consistent with the Magnuson-Stevens Act and other applicable laws. This rule has been determined to be not significant for purposes of Executive Order 12866. The Assistant Administrator for Fisheries
(AA)finds good cause under 5 U.S.C. 553(d)(3), to waive the 30-day delay in effectiveness of this final rule. The need to implement these measures in a timely manner to reduce the risk of overfishing in the monkfish fishery, constitutes good cause under authority contained in 5 U.S.C. 553(d)(3), to establish an effective date less than 30 days after date of publication. If Framework 5 measures are not in place at the start of the new fishing year (May 1, 2008), continuation of the less restrictive measures currently in place would increase the likelihood that the target TACs would be exceeded, potentially leading to overfishing if the target TACs are exceeded by a substantial amount. For example, gillnet vessels could continue to exploit the 3-hour provision to bypass effort controls, and certain large-mesh vessels in the SFMA would be able to continue fishing for monkfish without a sufficient cap on their incidental trip limits. This action could not be implemented earlier due to the fact that this rulemaking could not be completed until the predicate Council actions were completed. The final approval of Framework 5 by the Councils did not occur until their November 2007 and December 2007 meetings, respectively. The NEFMC submitted this action to NMFS on January 16, 2008, which did not allow sufficient time for review and publication of proposed and final rules prior to the start of the fishing year. In order to implement this final rule for the start of FY 2008, and prevent any negative impacts to the monkfish resource, such as overharvesting of the target TACs, resulting from a delay in implementation, the AA finds that there is good cause to waive the 30-day delay in effectiveness. Included in this final rule is the FRFA prepared pursuant to 5 U.S.C. 604(a). The FRFA incorporates the IRFA, a summary of the significant issues raised by the public comments in response to the IRFA, and NMFS's responses to those comments, and a summary of the analyses completed to support the action. A copy of the EA/RIR/IRFA is available from the Council (see ADDRESSES ). The preamble to the proposed rule included a detailed summary of the analyses contained in the IRFA, and that discussion is not repeated here. Final Regulatory Flexibility Analysis Statement of Objective and Need A description of the reasons why this action is being taken, and the objectives of and legal basis for this final rule are contained in the preambles to the proposed rule and this final rule and are not repeated here. Summary of Significant Issues Raised in Public Comments Three comments were submitted on the proposed rule, but none were specific to the IRFA or the economic effects of the rule. NMFS has responded to the comments in the Comments and Responses section of the preamble to this final rule. No changes were made to the final rule as a result of the comments received. Description and Estimate of Number of Small Entities to Which the Rule will Apply The Small Business Administration
(SBA)defines small businesses in the commercial fishing and recreational fishing sectors as firms with receipts (gross revenues) of up to $4.0 million and $6.5 million, respectively. No large entities participate in this fishery, as defined in section 601 of the RFA. Therefore, there are no disproportionate impacts between large and small vessels. As of November 30, 2007, there were 765 limited access monkfish permit holders and 2,142 vessels holding an open access Category E permit. In FY 2006, there were 616 limited access permits holders that participated in the monkfish fishery based on vessel trip report
(VTR)records. During the same period, 574 Category E permit holders reported landing monkish. Based on VTR information from FY 2006 (the most recent FY for which complete information is available) this action would affect up to 194 limited access monkfish vessels with carryover DAS; 101 limited access monkfish gillnet vessels landing monkfish on trips less than 3 hours in duration; 3 vessels using large mesh (and not on a DAS) or under a Skate Bait LOA in the SNE RMA and landing monkfish above the proposed 50 lb (23 kg) per day, up to 150 lb (68 kg) per trip incidental catch limit; and 525 vessels with a VMS that fish in the NFMA. Description of Projected Reporting, Recordkeeping, and Other Compliance Requirements No additional reporting, recordkeeping, or other compliance requirements are included in this final rule. This rule does not duplicate, overlap, or conflict with other Federal rules. Description of the Steps Taken to Minimize Economic Impact on Small Entities The effort controls and possession limits modified by this rule are constrained by the conservation objectives of the FMP, under the authority of the Magnuson-Stevens Act. However, steps were taken to minimize economic impacts on small entities by selecting measures that have less of an economic impact than the other alternatives considered, to the extent possible. The preferred alternative to reduce carryover DAS from 10 to 4 (alternative 2) does not have a substantially different economic impact than the alternative to reduce carryover DAS from 10 to 6 (alternative 1) since only a small number of vessels appear to be constrained by the current DAS allocations. However, by further restricting the amount of carryover DAS a vessel can carryover from on fishing year to the next, the preferred alternative would have a greater probability of keeping landings within the target TAC than the other DAS carryover alternative or the no action alternative. Allowing up to 4 carryover DAS allows limited access monkfish vessels some flexibility to make up for missed fishing opportunities, but addresses the Councils' concern that the use of these carryover DAS has resulted in overages in the target TAC in the SFMA in recent years, which is why this was selected as the preferred alternative. The preferred alternative to eliminate the 3-hour gillnet provision would affect approximately 100 monkfish gillnet vessels that have historically taken trips less than 3 hours in duration. However, only those vessels that take more trips than available, if using a 15-hour DAS (e.g. dividing total DAS by 0.625) could likely be impacted by this action. Only 5 monkfish gillnet vessels met this criteria. The preferred alternative (alternative 3B) is functionally equivalent from an economic impact perspective to the alternative to prohibit the landing of monkfish on trips less than 3 hours in duration (alternative 1) since under either alternative, a limited access monkfish vessel would be required to take a 15 hour DAS charge (0.625 DAS) in order to land monkfish. However, there were enforceablility concerns with alternative 1, which is why alternative 3B was selected as the preferred alternative. Alternative 2, which would allow vessels to land monkfish on one 3-hour trip per calendar day, would have an even smaller economic impact than alternatives 1 and 3B. If more than one 3-hour trip is taken in a calendar day, all but one trip would no longer be allowed, resulting in economic loss to the vessel. However, less than 1 percent of 3-hour trips in FY 2006 were the result of more than one trip within a calendar day. Similar to alternative 1, this alternative was not selected due to enforceability concerns. The revision to the incidental catch limit applicable to non-DAS vessels in the SFMA affects a relatively small number
(3)of vessels. In fact, the economic analysis contained in Framework 5 indicates that alternative 1A and the no action alternative are functionally the same from an economic perspective, but that the preferred alternative
(1B)would have a marginal affect on revenues for the affected vessels in comparison to the other two alternatives. Given the fact that there is a minimal difference in economic impacts among the 3 alternatives, alternative 1B was selected because it is the more restrictive of the 3 alternatives; therefore, providing a greater likelihood that this measure will help keep monkfish landings within the target TACs. In comparison to the no action alternative, the preferred alternative to remove the requirement to obtain a Monkfish LOA to fish in the NFMA for vessels using a VMS would reduce the administrative burden and potentially increase flexibility for limited access monkfish vessels, particularly those that fish in both the NFMA and SFMA. Although the positive economic effects associated with the preferred alternative are likely small, this alternative was selected because it would reduce administrative burden and increase flexibility. Overall, Framework 5 is expected to have long-term positive impacts on affected small entities. Under the new biological reference points implemented by this action, monkfish are no longer considered overfished, which eliminates the potential need for further management restrictions. Continued stability in the management program will potentially allow for higher and sustainable yields from the monkfish resource. The negative economic impacts from this action are estimated to be relatively minor, short-term, and affect comparatively few vessels. Small Entity Compliance Guide Section 212 of the Small Business Regulatory Enforcement Fairness Act of 1996 states that, for each rule or group of related rules for which an agency is required to prepare a FRFA, the agency shall publish one or more guides to assist small entities in complying with the rule, and shall designate such publications as “small entity compliance guides.” The agency shall explain the actions a small entity is required to take to comply with a rule or group of rules. As part of this rulemaking process, a small entity compliance guide will be sent to all holders of Federal permits issued for the monkfish fishery. In addition, copies of this final rule and guide (i.e., permit holder letter) are available from NMFS (see ADDRESSES ) and at the following website: *http://www.nero.noaa.gov* . List of Subjects in 50 CFR Part 648 Fisheries, Fishing, Reporting and recordkeeping requirements. Dated: April 21, 2008 Samuel D. Rauch III, Deputy Assistant Administrator For Regulatory Programs, National Marine Fisheries Service. For the reasons set out in the preamble, 50 CFR part 648 is amended as follows: PART 648—FISHERIES OF THE NORTHEASTERN UNITED STATES 1. The authority citation for part 648 continues to read as follows: Authority: 16 U.S.C. 1801 *et seq.* 2. In § 648.92, paragraphs (a)(1), (b)(3), (b)(4), and (b)(8)(v) are revised to read as follows: § 648.92 Effort-control program for monkfish limited access vessels.
(a)* * *
(1)*End of year carryover* . With the exception of a vessel that held a Confirmation of Permit History, as described in § 648.4(a)(1)(i)(J), for the entire fishing year preceding the carryover year, a limited access monkfish vessel that has unused monkfish DAS on the last day of April of any year may carry over a maximum of 4 unused monkfish DAS into the next fishing year. A vessel whose DAS have been sanctioned through enforcement proceedings shall be credited with unused DAS based on its DAS allocation minus any DAS that have been sanctioned.
(b)* * *
(3)*Accrual of DAS* . Same as § 648.53(f).
(4)*Good Samaritan credit* . Same as § 648.53(g).
(8)* * *
(v)*Method of counting DAS* . A vessel fishing with gillnet gear under a monkfish DAS shall accrue 15 hours monkfish DAS for all trips less than or equal to 15 hours in duration. Such vessels shall accrue monkfish DAS based on actual time at sea for trips greater than 15 hours in duration. A vessel fishing with gillnet gear under only a monkfish DAS is not required to remove gillnet gear from the water upon returning to the dock and calling out of the DAS program, provided the vessel complies with the requirements and conditions of paragraphs (b)(8)(i)-(v) of this section. A vessel fishing with gillnet gear under a joint monkfish and NE multispecies DAS, as required under § 648.92(b)(2)(i), that is declared as a trip gillnet vessel under the NE Multispecies FMP, must remove its gillnet gear from the water prior to calling out of the DAS program, as specified at § 648.82(j)(2). 3. In § 648.94, paragraphs (c)(3) and
(f)are revised to read as follows: § 648.94 Monkfish possession and landing restrictions.
(c)* * *
(3)*Vessels fishing with large mesh and not fishing under a DAS* —(i) A vessel issued a valid monkfish incidental catch limit (Category E) permit or a limited access monkfish permit (Category A, B, C, D, F, G, or H) fishing in the GOM or GB RMAs with mesh no smaller than specified at § 648.80(a)(3)(i) and (a)(4)(i), respectively, while not on a monkfish, NE multispecies, or scallop DAS, may possess, retain, and land monkfish (whole or tails) only up to 5 percent (where the weight of all monkfish is converted to tail weight) of the total weight of fish on board. For the purpose of converting whole weight to tail weight, the amount of whole weight possessed or landed is divided by 3.32.
(ii)A vessel issued a valid monkfish incidental catch (Category E) permit or a limited access monkfish permit (Category A, B, C, D, F, G, or H) fishing in the SNE RMA east of the MA Exemption Area boundary with mesh no smaller than specified at § 648.80(b)(2)(i), while not on a monkfish, NE multispecies, or scallop DAS, may possess, retain, and land monkfish (whole or tails) only up to 5 percent (where the weight of all monkfish is converted to tail weight) of the total weight of fish on board, not to exceed 50 lb (23 kg) tail weight or 166 lb (75 kg) whole weight of monkfish per day or partial day, up to a maximum of 150 lb (68 kg) tail weight or 498 lb (226 kg) whole weight per trip. For the purpose of converting whole weight to tail weight, the amount of whole weight possessed or landed is divided by 3.32.
(iii)A vessel issued a valid monkfish incidental catch (Category E) permit or a limited access monkfish permit (Category A, B, C, D, F, G, or H) fishing in the SNE RMA under a Skate Bait Letter of Authorization, as authorized under § 648.322(b), while not on a monkfish, NE multispecies, or scallop DAS, may possess, retain, and land monkfish (whole or tails) only up to 5 percent (where the weight of all monkfish is converted to tail weight) of the total weight of fish on board, not to exceed 50 lb (23 kg) tail weight or 166 lb (75 kg) whole weight of monkfish per day or partial day, up to a maximum of 150 lb (68 kg) tail weight or 498 lb (226 kg) whole weight per trip. For the purpose of converting whole weight to tail weight, the amount of whole weight possessed or landed is divided by 3.32.
(iv)A vessel issued a valid monkfish incidental catch (Category E) permit or a limited access monkfish permit (Category A, B, C, D, F, G, or H) fishing in the SNE or MA RMAs west of the MA Exemption Area boundary with mesh no smaller than specified at § 648.104(a)(1) while not on a monkfish, NE multispecies, or scallop DAS, may possess, retain, and land monkfish (whole or tails) only up to 5 percent (where the weight of all monkfish is converted to tail weight) of the total weight of fish on board, but not to exceed 450 lb (204 kg) tail weight or 1,494 lb (678 kg) whole weight of monkfish, unless that vessel is fishing under a Skate Bait Letter of Authorization in the SNE RMA. Such a vessel is subject to the incidental catch limit specified under paragraph (c)(3)(iii) of this section. For the purpose of converting whole weight to tail weight, the amount of whole weight possessed or landed is divided by 3.32.
(f)*Area declaration requirement for a vessel fishing exclusively in the NFMA* . A vessel intending to fish for, or fishing for, possessing or landing monkfish under a multispecies, scallop, or monkfish DAS under the less restrictive management measures of the NFMA, must fish exclusively in the NFMA for the entire trip. In addition, a vessel fishing under a monkfish DAS must declare its intent to fish in the NFMA through the vessel's VMS unit. A vessel that is not required to and does not possess a VMS unit, such as a vessel that declares DAS through the call-in system, must declare its intent to fish in the NFMA by obtaining a letter of authorization from the Regional Administrator, for a period of not less than 7 days. A vessel that has not declared into the NFMA under this paragraph
(f)shall be presumed to have fished in the SFMA and shall be subject to the more restrictive requirements of that area. A vessel that has declared into the NFMA may transit the SFMA, providing that it complies with the transiting and gear storage provision described in paragraph
(e)of this section, and provided that it does not fish for or catch monkfish, or any other fish, in the SFMA. [FR Doc. E8-9116 Filed 4-25-08; 8:45 am] BILLING CODE 3510-22-S 73 82 Monday, April 28, 2008 Proposed Rules NATIONAL CREDIT UNION ADMINISTRATION 12 CFR Parts 701 and 705 RIN 3133-AC98 The Low-Income Definition AGENCY: National Credit Union Administration (NCUA). ACTION: Proposed rule. SUMMARY: The NCUA is proposing to use median family income
(MFI)to determine if a credit union qualifies for a low-income designation and assistance from the Community Development Revolving Loan Fund (CDRLF). The proposed rule will eliminate the confusion associated with adjusting median household income
(MHI)in metropolitan areas with higher costs of living. Additionally, it will better align NCUA criteria for a low-income designation with the criteria for the addition of an underserved area to a federal credit union
(FCU)field of membership and certification as a Community Development Financial Institution (CDFI). DATES: Comments must be received on or before June 27, 2008. ADDRESSES: You may submit comments by any of the following methods (Please send comments by one method only): • *Federal eRulemaking Portal: http://www.regulations.gov.* Follow the instructions for submitting comments. • *NCUA Web Site: http://www.ncua.gov/news/proposed_regs/proposed_regs.html* . Follow the instructions for submitting comments. • *E-mail:* Address to *regcomments@ncua.gov.* Include “[Your name] Comments on Proposed Rule Parts 701 and 705” in the e-mail subject line. • *Fax:*
(703)518-6319. Use the subject line described above for e-mail. • *Mail:* Address to Mary Rupp, Secretary of the Board, National Credit Union Administration, 1775 Duke Street, Alexandria, Virginia 22314-3428. • *Hand Delivery/Courier:* Same as mail address. FOR FURTHER INFORMATION CONTACT: Moisette Green, Staff Attorney, Office of General Counsel, at the above address or telephone:
(703)518-6540. SUPPLEMENTARY INFORMATION: Background The Federal Credit Union Act
(Act)authorizes the NCUA Board to define “low-income members” so that credit unions with a membership predominantly consisting of low-income members can benefit from certain statutory relief and receive assistance from the CDRLF. 12 U.S.C. 1752(5), 1757a(b)(2)(A), 1752a(c)(2)(B), 1772c-1. NCUA defines “low-income members” in parts 701 and 705 of its regulations generally as meaning members whose annual household income falls at or below 80% of the national MHI, but provides a differential for certain geographic areas with higher costs of living. 12 CFR 701.34(a)(2), 705.3(a)(1). In 2006, NCUA's Member Service Assessment Pilot Program
(MSAP)recommended the Board consider reassessing the formula for determining if an FCU qualifies for a low-income designation. According to MSAP, using MFI would be more reflective of the regional economic diversity of the United States and of the circumstances in which FCU members live. The NCUA Outreach Task Force evaluated the MSAP recommendation, identified concerns with the current low-income formula, and agreed with MSAP that the standard for designating low-income credit unions should change from MHI to MFI. Specifically, NCUA proposes to revise the definition of “low-income members” in §§ 701.34(a)(2) and 705.3(a)(1) to base the determination on an “income standard” that relies on MFI or the alternative of median earnings. For metropolitan areas, the proposal defines low-income members as those living in an area, within the metropolitan area, where the standard is at or below 80% of either the standard for the entire metropolitan area or the national standard, whichever is greater. For members living outside a metropolitan area, the proposal defines low-income members as those living in an area where the standard is at or below 80% of either the statewide non-metropolitan area standard or the national non-metropolitan area standard, whichever is greater. The Census Bureau designates Metropolitan Areas in accordance with the standards developed by the U.S. Office of Management and Budget. Metropolitan Areas contain a core urban area of 50,000 or more in population and one or more counties, including the counties containing the core urban area and adjacent counties with a high degree of social and economic integration with the urban core. U.S. Census Bureau, *http://www.census.gov/population/www/estimates/metroarea.html* (April 7, 2008). The proposed rule will eliminate the confusion associated with adjusting the national MHI for metropolitan areas with higher costs of living. Additionally, it will better align the criteria for a low-income designation with the criteria adding an underserved area to an FCU field of membership
(FOM)and certification as a CDFI under Treasury Department regulations. *See* Interpretive Rulings and Policy Statement
(IRPS)03-1, 68 FR 18334 (April 15, 2003) (as amended by IRPS 06-1, 71 FR 36667 (June 28, 2006)); 12 CFR 1805.201(b)(3)(ii)(D)(2)(i)-(ii). The proposed amendment includes a five-year grandfather provision to allow existing low-income credit unions (LICUs) to qualify under the new MFI standard or adequate transition time if they no longer qualify for the low-income designation. The proposed rule is not changing or removing other current standards, which credit unions can use to qualify for a low-income designation, based on serving members who are enrolled as students in a college, university, high school, or vocational school. 12 CFR 701.34(a)(2)(ii). Median Household Income Standard MHI divides the income distribution into two equal groups, half having household incomes above the median, half having incomes below the median. The Census Bureau defines “household” as all the people who occupy a housing unit, such as a house, an apartment or other group of rooms established as separate living quarters. A household includes the related family members and all the unrelated people, if any, such as lodgers, foster children, wards, or employees who share the housing unit. A person living alone in a housing unit, or a group of unrelated people sharing a housing unit such as partners or roomers, is also counted as a household. Households do not include group quarters such as dormitories. In determining MHI for members of credit unions applying for a low-income designation, NCUA currently applies allowances to the national MHI for geographical areas with higher costs of living. The geographical differentials are based on data from the Employment and Training Administration of the Department of Labor. The differentials are outdated and do not account for all national high-cost areas defined in the current lower living standard income level differentials. *See* 71 FR 31215 (June 1, 2006). Consequently, some credit unions may not be eligible for low-income designation due to the outdated geographical area differentials in the current regulation. In addition to the outdated differentials, two concerns related to using MHI as a standard to determine low-income eligibility exist. First, using MHI is inconsistent with the standard NCUA uses to assess whether an area is underserved and has caused confusion between the definitions of “low income” and “underserved.” Second, NCUA's use of the MHI standard is not consistent with the qualification standard used by other federal agencies with policies to foster low-income initiatives, specifically the Treasury Department's CDFI Fund. Median Family Income Standard The Board believes MFI should be the standard used to determine whether a credit union qualifies for a low-income designation. MFI is the amount that divides the income distribution into two equal groups, half having family incomes above the median, half having incomes below the median. The median is based on family members 16 years old and over with income. The Census Bureau defines a “family” as a group of two or more people related by birth, marriage, or adoption and residing together. MFI is available from the U.S. Census Bureau for both non-metropolitan and metropolitan areas. This is an advantage because it eliminates the need to adjust the income standard for areas with higher costs of living. Inconsistency With Underserved Area Definition NCUA's low-income definition using the MHI standard preceded amendments to FOM provisions in the FCU Act regarding underserved areas. NCUA began using MHI to determine if a credit union qualified for a low-income designation in 1993. 56 FR 21645 (April 23, 1993). In 1998, the FCU Act was amended to permit multiple common-bond FCUs to add underserved areas if, among other requirements, the area met the definition of an “investment area,” as defined in § 103(16) of the Community Development Banking and Financial Institutions Act of 1994. Credit Union Membership Access Act (CUMAA), Public Law 105-219, § 101, 112 Stat. 913, 915
(1998)(codified at 12 U.S.C. 1759(c)(2)(A)(i)); Public Law 103-325, § 103(16), 108 Stat. 2163 (1994). Treasury Department regulations, implementing the Community Development Banking and Financial Institution Act of 1994, include an MFI at or below 80 percent of the MFI for corresponding metropolitan area as a factor supporting the determination that an area is an investment area. 12 CFR 1805.201(b). As required by CUMAA, NCUA implemented the authority for service to underserved areas by looking to the definition of investment area and included the 80 percent of MFI standard among the criteria that can be used to qualify an underserved area as an investment area. NCUA Chartering and Field of Membership Manual, Chapter 3, II.A., Interpretive Rulings and Policy Statement
(IRPS)03-1, 68 FR 18334 (April 15, 2003) (as amended by IRPS 06-1, 71 FR 36667 (June 28, 2006)). While the 80 percent of MFI standard is among the criteria that can be used to qualify an underserved area as an investment area, an FCU that adds an underserved area does not automatically qualify for the low-income designation. The low-income formula, however, did not change with the FOM amendments, causing inconsistency within NCUA regulations and creating confusion between the benchmarks used for determining low-income designation and if an area is underserved. The use of MFI as a standard to determine low-income status will bring uniformity and consistency to the regulations, and should eliminate industry confusion regarding the low-income designation and application for an underserved area. Inconsistency With the Community Development Financial Institutions Fund Generally, the current MHI standard differs from the standard other federal agencies use to promote outreach programs, most importantly the Treasury Department's CDFI Fund. The CDFI Fund, through monetary awards and other benefits, helps promote access to capital and local economic growth in urban and rural low-income communities across the nation. Qualifying credit unions obtain assistance from the CDFI Fund to offer financial services to and further economic development of low-income members. The CDFI Fund uses MFI to implement the Community Development Banking and Financial Institutions Act of 1994, as previously discussed. This has created confusion and, in many instances, placed additional and unnecessary burdens on credit unions attempting to qualify for a low-income designation and assistance from the CDFI Fund. The CDFI Fund defines “low income” as an income, adjusted for family size, of not more than 80 percent of the metropolitan area MFI or, if appropriate, non-metropolitan area MFI. 12 CFR 1805.104(ee). Because credit unions may apply for financial assistance from the CDFI Fund, the Board believes it would be beneficial to align the low-income formula with the CDFI Fund criteria. This would reduce the regulatory burden on federally-insured credit unions attempting to qualify for benefits of a low-income designation and from the CDFI Fund. Proposed Rule The proposed rule amends the definition of “low-income members” to use the MFI as an income standard instead of MHI. NCUA recognizes not all credit union members meet the Census Bureau's definition of “family.” Therefore, the proposed rule permits credit unions to use the median earnings for individuals reported by the Census Bureau as an alternate income standard for MFI. It also defines the geographic areas NCUA will consider when determining whether a credit union qualifies for a low-income designation. Additionally, the proposed rule clarifies the process for removing a low-income designation. If a credit union no longer qualifies for the designation, a regional director will give the credit union written notice. Loss of the designation may result for various reasons, including changes in FOM or as a result of mergers, assumptions of member shares from liquidating credit unions, or other similar occurrences. A credit union will have five years after the date of the written notice to come into compliance with regulations applicable to credit unions that do not have a low-income designation. A credit union may appeal the loss of its low-income designation to the Board; an appeal must be filed within 60 days of the date of the written notice of loss of the designation. A credit union will submit its appeal through the appropriate regional office. The five-year period provides LICUs that lose their low-income designation adequate time to comply with regulatory requirements regarding secondary capital (§ 701.34 and part 702), member business loans (§ 723.17), nonmember deposits (§ 701.32), and CDRLF financial assistance (12 CFR part 705). The reasons for a five-year period include the fact that NCUA regulations require a minimum maturity of five years for secondary capital, 12 CFR 701.31(b)(4)), and CDRLF loans have a maximum maturity of five years, 12 CFR 705.7(c). If a LICU loses its designation under the MFI standard and must repay secondary capital, a CDRLF loan, nonmember deposits, or reduce its member business loans, the five-year period should provide adequate time to make the necessary adjustments. Finally, the proposed rule makes a conforming amendment to § 705.3, namely, that the meaning of low-income members will be the same in that section as in § 701.34 and will clarify that credit unions qualifying for the low-income designation under § 701.34 may apply for assistance from the CDRLF. Part 705 and § 701.34 would continue to apply to state-chartered credit unions in accordance with § 741.204. Five-Year Grandfather Provision for Current LICUs The Board does not anticipate changing from MHI to MFI will have a significant impact on the number of credit unions qualifying for a low-income designation. To offset any potential adverse impact from the change to the MFI standard, the proposed rule includes a grandfather provision to permit current LICUs not meeting the new standard to retain the designation for a five-year period after a final rule becomes effective. During this five-year period LICUs may take advantage of the benefits associated with a low-income designation, including continuing to be eligible for CDRLF program. The reasons for a five-year period for a grandfather provision are the same as those noted above for a five-year period following a loss of the designation for other reasons. By the end of five years after the effective date of a final rule, all LICUs must qualify for the designation using the MFI standard. Any LICU failing to qualify under the MFI standard would automatically lose the low-income designation at the end of this five-year period. Loss of the low-income designation for failure to meet the MFI standard within five years of the effective date of a final rule would not be appealable to the Board. Regulatory Procedures Regulatory Flexibility Act The Regulatory Flexibility Act requires NCUA to prepare an analysis to describe any significant economic impact any regulation may have on a substantial number of small entities. 5 U.S.C. 603(a). For purposes of this analysis, NCUA considers credit unions having under $10 million in assets small entities. Interpretive Ruling and Policy Statement 03-2, 68 FR 31949 (May 29, 2003). As of December 31, 2007, out of approximately 8,410 federally insured credit unions, 3,599 had less than $10 million in assets. This proposed rule directly affects all low-income credit unions, of which there are approximately 1,087. NCUA estimates approximately 692 low-income credit unions are small entities. Therefore, NCUA has determined this proposed rule will have an impact on a substantial number of small entities. NCUA has determined, however, the economic impact on entities affected by the proposed rule will not be significant. The proposed rule will better align criteria for a low-income designation with the criteria for the addition of an underserved area to a federal credit union field of membership under IRPS 03-1 (as amended by 06-1) and certification as a CDFI. The proposed rule will establish one income standard for determining a low-income designation, underserved areas, and investment areas. It will also eliminate the confusion within the credit union industry due to the use of different income standards. NCUA believes the proposed rule will reduce the regulatory burden for LICUs and any economic impact will be minimal. Additionally, NCUA has proposed a five-year period for LICUs affected to make necessary adjustments. Accordingly, the Board certifies this rule will not have a significant economic impact on a substantial number of small entities. NCUA invites comment from the public on whether the proposal will have a significant economic impact on small entities. Paperwork Reduction Act The proposed rule does not contain a “collection of information” within the meaning of section 3502(3) of the Paperwork Reduction Act of 1995 (44 U.S.C. 3502(3)) and would not increase paperwork requirements under the Paperwork Reduction Act of 1995 or regulations of the Office of Management and Budget. Executive Order 13132 Executive Order 13132 encourages independent regulatory agencies to consider the impact of their actions on state and local interests. In adherence to fundamental federalism principles, NCUA, an independent regulatory agency as defined in 44 U.S.C. 3502(5), voluntarily complies with the executive order. The proposed rule would not have substantial direct effect on the states, on the connection between the national government and the states, or on the distribution of power and responsibilities among the various levels of government. NCUA has determined this proposed rule does not constitute a policy that has federalism implications for purposes of the executive order. The Treasury and General Government Appropriations Act, 1999—Assessment of Federal Regulations and Policies on Families NCUA has determined that this proposed rule would not affect family well-being within the meaning of section 654 of the Treasury and General Government Appropriations Act, 1999, Public Law 105-277, 112 Stat. 2681 (1998). Agency Regulatory Goal NCUA's goal is to promulgate clear and understandable regulations that impose minimal regulatory burden. We request your comments on whether the proposed amendment is understandable and minimally intrusive if implemented as proposed. List of Subjects 12 CFR Part 701 Credit unions, Low income, Nonmember deposits, Secondary capital, Shares. 12 CFR Part 705 Community development, Credit unions, Loans, Low income, Technical assistance. By the National Credit Union Administration Board, on April 17, 2008. Mary F. Rupp, Secretary of the Board. For the reasons stated above, NCUA proposes to amend 12 CFR parts 701 and 705 as follows: PART 701—ORGANIZATION AND OPERATIONS OF FEDERAL CREDIT UNIONS 1. The authority citation for part 701 continues to read as follows: Authority: 12 U.S.C. 1752(5), 1757, 1765, 1766, 1781, 1782, 1787, 1789; Title V, Public Law 109-351, 120 Stat. 1966. 2. Amend § 701.34 by revising paragraph
(a)to read as follows: § 701.34 Designation of low income status; Acceptance of secondary capital accounts by low-income designated credit unions.
(a)*Designation of low-income status* .
(1)A regional director will designate a federal credit union as a low-income credit union if a majority of its membership qualifies as low-income members. As provided in § 701.32, low-income credit unions may receive shares from nonmembers.
(2)A regional director will remove the designation if the federal credit union no longer meets the criteria of this section and will give the credit union written notice. The credit union will have five years after the date of the written notice to come into compliance with regulatory requirements applicable to credit unions that do not have a low-income designation. A federal credit union may appeal the loss of its designation as a low-income credit union to the Board within 60 days of the date of the notice from the regional director. An appeal must be submitted to the regional director.
(3)*Definitions* . The following definitions apply to this section: *Geographic area* means an area within the United States, including any State, the District of Columbia, American Samoa, Guam, the Northern Mariana Islands, Puerto Rico, the Virgin Islands, or any territory of the United States or a geographic unit that is a county or equivalent area, a unit of a local government, incorporated place, census tract, block numbering area, Zip Code Tabulation Area, block group, or Native American, American Indian, or Alaskan Native area, as such units are defined or reported by the U.S. Census Bureau. *Income standard* means the median income for families or median earnings for individuals, as reported by the U.S. Census Bureau. *Low-income members* means those members: enrolled as students in a college, university, high school, or vocational school; living in a geographic area within a Metropolitan Area, where the median income is at or below 80% of the greater of the Metropolitan Area income standard or the national Metropolitan Area income standard; or living in a geographic area outside a Metropolitan Area, where the median income is at or below 80% of the greater of the statewide, non-Metropolitan Area income standard or the national non-Metropolitan Area income standard.
(4)Any credit union designated as a low-income credit union on the [EFFECTIVE DATE OF THE FINAL RULE] will have five years from that date to meet the criteria for low-income designation under paragraph (a)(1) of this section. PART 705—COMMUNITY DEVELOPMENT REVOLVING LOAN FUND FOR CREDIT UNIONS 3. The authority citation for part 705 continues to read as follows: Authority: 12 U.S.C. 1772c-1; 42 U.S.C. 9822 and 9822 note. 4. Amend § 705.3 by revising paragraph
(a)to read as follows: § 705.3 Definitions.
(a)The term “low-income members” means those members defined in § 701.34 of this chapter. [FR Doc. E8-8968 Filed 4-25-08; 8:45 am] BILLING CODE 7535-01-P NATIONAL CREDIT UNION ADMINISTRATION 12 CFR Part 740 RIN 3133-AD45 The Official Advertising Statement AGENCY: National Credit Union Administration (NCUA). ACTION: Proposed rulemaking. SUMMARY: The NCUA Board proposes revising the requirements for use of the official insurance sign and official advertising statement to permit insured credit unions to use the basic form of the official advertising statement, a shortened form, or the official sign in advertisements. The proposed rule will give credit unions added flexibility in advertisements. As compared to the current requirement, credit unions will be able to use the shortened form or the official insurance sign in advertisements as alternatives to the basic official advertising statement; under the current rule, credit unions may only use the shortened form if they also include the official sign. DATES: Comments must be received on or before June 27, 2008. ADDRESSES: You may submit comments by any of the following methods (Please send comments by one method only): • *Federal eRulemaking Portal: http://www.regulations.gov.* Follow the instructions for submitting comments. • *NCUA Web site: http://www.ncua.gov/RegulationsOpinionsLaws/proposed_regs/proposed_regs.html* . Follow the instructions for submitting comments. • *E-mail:* Address to *regcomments@ncua.gov.* Include “[Your name] Comments on Proposed Part 740” in the e-mail subject line. • *Fax:*
(703)518-6319. Use the subject line described above for e-mail. • *Mail:* Address to Mary Rupp, Secretary of the Board, National Credit Union Administration, 1775 Duke Street, Alexandria, Virginia 22314-3428. • *Hand Delivery/Courier:* Same as mail address. FOR FURTHER INFORMATION CONTACT: Moisette I. Green, Staff Attorney, Office of General Counsel, at the above address or telephone:
(703)518-6540. SUPPLEMENTARY INFORMATION: NCUA continually reviews its regulations to “update, clarify and simplify existing regulations and eliminate redundant and unnecessary provisions.” NCUA Interpretive Ruling and Policy Statement
(IRPS)87-2, Developing and Reviewing Government Regulations. Under IRPS 87-2, NCUA conducts a rolling review of one-third of its regulations every year, involving both internal review and public comment. As a part of its 2007 regulatory review, NCUA identified an improvement for part 740, the regulation governing notice of insured status, providing insured credit unions greater flexibility in how they meet the requirement of giving notice of their insured status. The Federal Credit Union Act
(Act)requires insured credit unions to display signs at their places of business indicating accounts are insured and also to include in all advertisements a statement to the effect that accounts are insured. 12 U.S.C. 1785(a). The Act authorizes the NCUA Board to promulgate regulations governing the substance of the official insurance sign and the manner it is displayed or used and, also, to address the practicality of including the official statement on insured status in advertisements. *Id.* NCUA implements this authority in part 740 of its regulations and, in § 740.5, NCUA requires insured credit unions to include the official advertising statement in all advertisements, including on their main internet pages, with certain exceptions. The basic form of the official statement is “This credit union is federally insured by the National Credit Union Administration.” Currently, the regulation permits shortening the official statement to “Federally insured by NCUA” if used with a reproduction of the official sign in § 740.4(b). NCUA proposes to revise § 740.5(b) to permit insured credit unions to use, in addition to the basic form of the official advertising statement, the shortened form *or* the official sign in their advertisements. In other words, the proposed rule will permit insured credit unions, in addition to using the official advertising statement in its advertisements, to use the shortened statement alone or the official sign alone in advertisements. The flexibility this would provide is currently available under the Federal Deposit Insurance Corporation's rule regarding disclosure of insured status in advertisements. 12 CFR 328.3. Additionally, the proposed amendment clarifies the font of the text in the official sign may be altered as described in § 740.4(b)(2) when it is used as the official advertising statement. 12 CFR 740.4(b)(2). Regulatory Procedures Regulatory Flexibility Act The Regulatory Flexibility Act requires NCUA to prepare an analysis to describe any significant economic impact any proposed regulation may have on a substantial number of small credit unions (those under $10 million in assets). The proposed amendment merely expands the options credit unions have to comply with the requirement to notify members and the public of their insured status in advertisements. Accordingly, the NCUA has determined and certifies that the proposed rule, if adopted, will not have a significant economic impact on a substantial number of small credit unions within the meaning of the Regulatory Flexibility Act, 5 U.S.C. 601-612. Paperwork Reduction Act The proposed rule does not contain a “collection of information” within the meaning of section 3502(3) of the Paperwork Reduction Act of 1995 (44 U.S.C. 3502(3)) and would not increase paperwork requirements under the Paperwork Reduction Act of 1995 or regulations of the Office of Management and Budget. Executive Order 13132 Executive Order 13132 encourages independent regulatory agencies to consider the impact of their actions on state and local interests. In adherence to fundamental federalism principles, NCUA, an independent regulatory agency as defined in 44 U.S.C. 3502(5), voluntarily complies with the executive order. The proposed rule would not have substantial direct effect on the states, on the connection between the national government and the states, or on the distribution of power and responsibilities among the various levels of government. NCUA has determined that this proposed rule does not constitute a policy that has federalism implications for purposes of the executive order. The Treasury and General Government Appropriations Act, 1999—Assessment of Federal Regulations and Policies on Families NCUA has determined that this proposed rule would not affect family well-being within the meaning of section 654 of the Treasury and General Government Appropriations Act, 1999, Pub. L. 105-277, 112 Stat. 2681 (1998). Agency Regulatory Goal NCUA's goal is to promulgate clear and understandable regulations that impose minimal regulatory burden. We request your comments on whether the proposed amendment is understandable and minimally intrusive if implemented as proposed. List of Subjects in 12 CFR Part 740 Advertisements, Credit unions, Signs and symbols. By the National Credit Union Administration Board on April 17, 2008. Mary F. Rupp, Secretary of the Board. For the reasons set forth above, it is proposed that 12 CFR part 740 be amended as follows: PART 740—ACCURACY OF ADVERTISING AND NOTICE OF INSURED STATUS 1. The authority citation for part 740 is revised to read as follows: Authority: 12 U.S.C. 1766, 1781, 1785, and 1789. 2. Section 740.5 is amended by revising paragraph
(b)to read as follows: § 740.5 Requirements for the official advertising statement.
(b)The official advertising statement is in substance as follows: “This credit union is federally insured by the National Credit Union Administration.” Insured credit unions, at their option, may use the short title “Federally insured by NCUA” or a reproduction of the official sign, as described in § 740.4(b), as the official advertising statement. The official advertising statement must be in a size and print that is clearly legible. If the official sign is used as the official advertising statement, an insured credit union may alter the font size to ensure its legibility as provided in paragraph (b)(2) of § 740.4. [FR Doc. E8-8967 Filed 4-25-08; 8:45 am] BILLING CODE 7535-01-P DEPARTMENT OF TRANSPORTATION Federal Aviation Administration 14 CFR Part 39 [Docket No. FAA-2008-0415; Directorate Identifier 2007-NM-256-AD] RIN 2120-AA64 Airworthiness Directives; Boeing Model 737 Airplanes AGENCY: Federal Aviation Administration (FAA), DOT. ACTION: Notice of proposed rulemaking (NPRM). SUMMARY: We propose to adopt a new airworthiness directive
(AD)for certain Boeing Model 737 airplanes. This proposed AD would require repetitive inspections, lubrications, and repetitive repairs/overhauls of the ball nut and ballscrew and attachment (Gimbal) fittings for the trim actuator of the horizontal stabilizer; various installation(s); and corrective actions if necessary; as applicable. This proposed AD results from a report of extensive corrosion of a ballscrew used in the drive mechanism of the horizontal stabilizer trim actuator (HSTA). We are proposing this AD to prevent an undetected failure of the primary load path for the ballscrew in the drive mechanism of the HSTA and subsequent wear and failure of the secondary load path, which could lead to loss of control of the horizontal stabilizer and consequent loss of control of the airplane. DATES: We must receive comments on this proposed AD by June 12, 2008. ADDRESSES: You may send comments by any of the following methods: • *Federal eRulemaking Portal:* Go to *http://www.regulations.gov.* Follow the instructions for submitting comments. • *Fax:* 202-493-2251. • *Mail:* U.S. Department of Transportation, Docket Operations, M-30, West Building Ground Floor, Room W12-140, 1200 New Jersey Avenue, SE., Washington, DC 20590. • *Hand Delivery:* U.S. Department of Transportation, Docket Operations, M-30, West Building Ground Floor, Room W12-140, 1200 New Jersey Avenue, SE., Washington, DC 20590, between 9 a.m. and 5 p.m., Monday through Friday, except Federal holidays. For service information identified in this AD, contact Boeing Commercial Airplanes, P.O. Box 3707, Seattle, Washington 98124-2207. Examining the AD Docket You may examine the AD docket on the Internet at *http://www.regulations.gov;* or in person at the Docket Management Facility between 9 a.m. and 5 p.m., Monday through Friday, except Federal holidays. The AD docket contains this proposed AD, the regulatory evaluation, any comments received, and other information. The street address for the Docket Office (telephone 800-647-5527) is in the ADDRESSES section. Comments will be available in the AD docket shortly after receipt. FOR FURTHER INFORMATION CONTACT: Kelly McGuckin, Aerospace Engineer, Systems and Equipment Branch, ANM-130S, FAA, Seattle Aircraft Certification Office, 1601 Lind Avenue, SW., Renton, Washington 98057-3356; telephone
(425)917-6490; fax
(425)917-6590. SUPPLEMENTARY INFORMATION: Comments Invited We invite you to send any written relevant data, views, or arguments about this proposed AD. Send your comments to an address listed under the ADDRESSES section. Include “Docket No. FAA-2008-0415; Directorate Identifier 2007-NM-256-AD” at the beginning of your comments. We specifically invite comments on the overall regulatory, economic, environmental, and energy aspects of this proposed AD. We will consider all comments received by the closing date and may amend this proposed AD because of those comments. We will post all comments we receive, without change, to *http://www.regulations.gov,* including any personal information you provide. We will also post a report summarizing each substantive verbal contact we receive about this proposed AD. Discussion On January 31, 2000, there was an accident involving a McDonnell Douglas Model DC-9-83 (MD-83) airplane. The National Transportation Safety Board
(NTSB)determined that the probable cause of the accident was a loss of airplane pitch control resulting from the in-flight failure of the acme nut threads of the jackscrew assembly of the horizontal stabilizer trim system. The NTSB concluded that the thread failure was caused by excessive wear, resulting from insufficient lubrication of the jackscrew assembly. The drive mechanism of the horizontal stabilizer on Model MD-83 airplanes has a jackscrew assembly with an acme screw. The drive mechanism of the horizontal stabilizer on Boeing Model 737 airplanes has a horizontal stabilizer trim actuator
(HSTA)with a ballscrew. Acme screws and ballscrews have some differences in design, but perform similar functions and have the same airplane-level effect following failure. In response to this accident, Boeing initiated a design review and safety analysis of the primary and secondary load paths of the ballscrew assembly used on the HSTA of their airplanes. During this review, one operator of a Model 757 airplane reported extensive corrosion of a ballscrew assembly of the HSTA. Investigation revealed extensive corrosion of the primary load path ball bearings in the ballscrew assembly. This condition, if not corrected, could result in an undetected failure of the primary load path for the ballscrew in the drive mechanism of the HSTA and subsequent wear and failure of the secondary load path, which could lead to loss of control of the horizontal stabilizer and consequent loss of control of the airplane. The ballscrew assembly on Model 757 airplanes is similar to those on the affected Model 737 airplanes. Therefore, all of these models may be subject to the same unsafe condition. Other Relevant Rulemaking We are considering additional rulemaking to address the identified unsafe condition on Model 757 airplanes. Relevant Service Information We have reviewed the following Boeing Service Bulletins: Table—Primary Service Bulletins Boeing Alert Service Bulletin— Describes the following procedures for the trim actuator of the horizontal stabilizer (depending on the airplane configuration)— And recommends that those actions be done— 737-27A1277, Revision 1, dated July 25, 2007 (for Model 737-600, -700, -700C, -800, -900, and -900ER series airplanes) Repetitive detailed and general visual inspections to detect discrepancies (e.g., metal particles or corrosion in grease, damage, cracks, corrosion, worn areas, grease leakage, and loose ball bearings) of the ball nut and ballscrew Within 6,400 flight hours or 18 months from the last detailed inspection, whichever occurs first, and thereafter at intervals not to exceed 6,400 flight hours or 2 years, whichever occurs first. Repetitive lubrications of the ball nut and ballscrew Within 1,600 flight hours or 1 year from the last lubrication, whichever occurs first, and thereafter at intervals not to exceed 1,600 flight hours or 1 year, whichever occurs first. Repetitive repair/overhaul Before the accumulation of 25,000 flight hours since the date of issuance of the original standard airworthiness certificate or the date of issuance of the original export certificate of airworthiness, or within 25,000 flight hours since the last overhaul of the trim actuator of the horizontal stabilizer, whichever occurs first, and thereafter at intervals not to exceed 25,000 flight hours. Installation of tube retainers on the ball nut Before the accumulation of 25,000 flight hours since the date of issuance of the original standard airworthiness certificate or the date of issuance of the original export certificate of airworthiness, or within 25,000 flight hours since the latest overhaul of the trim actuator of the horizontal stabilizer, whichever occurs later. Applicable corrective actions. The corrective actions include repairing/replacing discrepant parts Before further flight. 737-27A1278, dated May 24, 2007 (for Model 737-100, -200, -200C, -300, -400, and -500 series airplanes) Repetitive detailed and general visual inspections to detect discrepancies (e.g., metal particles or corrosion in grease, damage, cracks, corrosion, worn areas, grease leakage, and loose ball bearings) of the ball nut and ballscrew and attachment (Gimbal) fittings Within 2,000 or 4,000 flight hours or 12 or 18 months from the last detailed inspection, whichever occurs first, and thereafter at intervals not to exceed 2,000 or 4,000 flight hours or 1 or 2 years, whichever occurs first (depending on the airplane configuration). Repetitive lubrications of the ball nut and ballscrew and attachment (Gimbal) fittings Within 500 or 2,000 flight hours or 2 months or 1 year from the last lubrication, whichever occurs first, and thereafter at intervals not to exceed 500 or 2,000 flight hours or 2 months or 1 year, whichever occurs first (depending on the airplane configuration). Repetitive repair/overhaul Before the accumulation of 20,000 flight hours or 24,000 flight hours since the date of issuance of the original standard airworthiness certificate or the date of issuance of the original export certificate of airworthiness, or within 20,000 flight hours or 24,000 flight hours since the last overhaul of the trim actuator of the horizontal stabilizer, whichever occurs first (depending on the airplane configuration); and thereafter at intervals not to exceed 20,000 or 25,000 flight cycles (depending on the airplane configuration). Installation of tube retainers on the ball nut Before the accumulation of 24,000 flight hours since the date of issuance of the original standard airworthiness certificate or the date of issuance of the original export certificate of airworthiness, or within 24,000 flight hours since the last overhaul of the trim actuator of the horizontal stabilizer, whichever occurs first. Installation of a grease fitting Before the accumulation of 20,000 flight hours since the date of issuance of the original standard airworthiness certificate or the date of issuance of the original export certificate of airworthiness, or within 20,000 flight hours since the last overhaul of the trim actuator of the horizontal stabilizer, whichever occurs first. Installation of new ball deflectors and guide clamps for the ball return Before the accumulation of 24,000 flight hours since the date of issuance of the original standard airworthiness certificate or the date of issuance of the original export certificate of airworthiness, or within 24,000 flight hours since the last overhaul of the trim actuator of the horizontal stabilizer, whichever occurs first. Installation of new return tube clamps Before the accumulation of 20,000 flight hours since the date of issuance of the original standard airworthiness certificate or the date of issuance of the original export certificate of airworthiness, or within 20,000 flight hours since the last overhaul of the trim actuator of the horizontal stabilizer, whichever occurs first. Applicable corrective actions. The corrective actions include repairing/replacing discrepant parts Before further flight. Table.—Secondary Service Bulletins Boeing Alert Service Bulletin— Refers to— 737-27A1277, Revision 1, dated July 25, 2007 (for Model 737-600, -700, -700C, -800, -900, and -900ER series airplanes) UMBRA CUSCINETTI Service Bulletin 07322-27-01, dated December 21, 2004, as an additional source of service information for installing tube retainers on the ball nut. 737-27A1278, dated May 24, 2007 (for Model 737-100, -200, -200C, -300, -400, and -500 series airplanes) UMBRA CUSCINETTI Service Bulletin 07322-27-01, dated December 21, 2004, as an additional source of service information for installing tube retainers on the ball nut. Boeing 737 Service Bulletin 27-1046, Revision 1, dated April 5, 1974, as an additional source of service information for installing a grease fitting. Linear Motion Service Bulletin 7901708, Revision A, dated July 26, 2005, as an additional source of service information for installing new ball deflectors and guide clamps for the ball return. SKYTRONICS Service Bulletin 93004, dated September 1, 2005, as an additional source of service information for installing new return tube clamps. FAA's Determination and Requirements of This Proposed AD We are proposing this AD because we evaluated all relevant information and determined the unsafe condition described previously is likely to exist or develop in other products of the(se) same type design(s). This proposed AD would require accomplishing the actions specified in the primary service bulletins described previously. Clarification of Applicability of This AD Boeing has informed us that Model 737-900ER series airplanes were not specifically identified by model name in the Effectivity section of Boeing Alert Service Bulletin 737-27A1277. However, those airplanes are identified by variable numbers in the Effectivity section. Therefore, this AD refers to Model 737-900ER series airplanes where appropriate. Costs of Compliance We estimate that this proposed AD would affect 1,602 Model 737 airplanes of U.S. registry. The following table provides the estimated costs for U.S. operators to comply with this proposed AD. Estimated Costs Action 1 Work hours 1 Average labor rate per hour Parts Cost per product 1 Number of U.S.-registered airplanes Fleet cost 1 Detailed inspections 2 or 4 $80 None $160 or $320, per inspection cycle 1,602 Between $256,320, and $512,640 per inspection cycle. Lubrications 1 or 3 80 None $80 or $240, per lubrication cycle 1,602 Between $128,160, and $384,480 per lubrication cycle. Repairs/overhauls 40 80 None $3,200 per repair/overhaul 1,602 $5,126,400 per repair/overhaul cycle. Installations Between 1 and 3 80 $2,200 Between $2,280 and $2,440 1,320 Between $3,009,600 and $3,220,800. 1 Depending on airplane configuration. The number of work hours, as indicated above, is presented as if the accomplishment of the actions in this proposed AD is to be conducted as new “stand alone” actions. However, in actual practice, the lubrications, detailed inspections, and overhauls are currently being done as part of normal airplane maintenance. The repair can be done coincidentally or in combination with the normally scheduled HSTA and ballscrew overhaul. Therefore, the actual number of necessary additional work hours will be minimal in many instances. Additionally, any costs associated with special airplane scheduling will be minimal. Authority for This Rulemaking Title 49 of the United States Code specifies the FAA's authority to issue rules on aviation safety. Subtitle I, section 106, describes the authority of the FAA Administrator. “Subtitle VII: Aviation Programs,” describes in more detail the scope of the Agency's authority. We are issuing this rulemaking under the authority described in “Subtitle VII, Part A, Subpart III, Section 44701: General requirements.” Under that section, Congress charges the FAA with promoting safe flight of civil aircraft in air commerce by prescribing regulations for practices, methods, and procedures the Administrator finds necessary for safety in air commerce. This regulation is within the scope of that authority because it addresses an unsafe condition that is likely to exist or develop on products identified in this rulemaking action. Regulatory Findings We determined that this proposed AD would not have federalism implications under Executive Order 13132. This proposed AD would not have a substantial direct effect on the States, on the relationship between the national Government and the States, or on the distribution of power and responsibilities among the various levels of government. For the reasons discussed above, I certify this proposed regulation: 1. Is not a “significant regulatory action” under Executive Order 12866, 2. Is not a “significant rule” under the DOT Regulatory Policies and Procedures (44 FR 11034, February 26, 1979), and 3. Will not have a significant economic impact, positive or negative, on a substantial number of small entities under the criteria of the Regulatory Flexibility Act. You can find our regulatory evaluation and the estimated costs of compliance in the AD Docket. List of Subjects in 14 CFR Part 39 Air transportation, Aircraft, Aviation safety, Safety. The Proposed Amendment Accordingly, under the authority delegated to me by the Administrator, the FAA proposes to amend 14 CFR part 39 as follows: PART 39—AIRWORTHINESS DIRECTIVES 1. The authority citation for part 39 continues to read as follows: Authority: 49 U.S.C. 106(g), 40113, 44701. § 39.13 [Amended] 2. The FAA amends § 39.13 by adding the following new AD: **Boeing:** Docket No. FAA-2008-0415; Directorate Identifier 2007-NM-256-AD. Comments Due Date
(a)We must receive comments by June 12, 2008. Affected ADs
(b)None. Applicability
(c)This AD applies to Boeing airplanes identified in Table 1 of this AD, certificated in any category. Table 1.—Applicability Boeing model— As identified in Boeing Alert Service Bulletin—
(1)737-100, -200, -200C, -300, -400, and -500 series airplanes 737-27A1278, dated May 24, 2007.
(2)737-600, -700, -700C, -800, -900, and -900ER series airplanes 737-27A1277, Revision 1, dated July 25, 2007. Unsafe Condition
(d)This AD results from a report of extensive corrosion of a ballscrew in the drive mechanism of the horizontal stabilizer trim actuator (HSTA). We are issuing this AD to prevent an undetected failure of the primary load path for the ballscrew in the drive mechanism of the HSTA and subsequent wear and failure of the secondary load path, which could lead to loss of control of the horizontal stabilizer and consequent loss of control of the airplane. Compliance
(e)Comply with this AD within the compliance times specified, unless already done. Service Bulletins
(f)The term “service bulletin,” as used in this AD, means the applicable service bulletins specified in Table 2 of this AD. Table 2.—Service Bulletins Boeing Alert Service Bulletin— For model—
(1)737-27A1278, dated May 24, 2007 737-100, -200, -200C, -300, -400, and -500 series airplanes.
(2)737-27A1277, Revision 1, dated July 25, 2007 737-600, -700, -700C, -800, -900, and -900ER series airplanes. Note 1: The service bulletins refer to UMBRA CUSCINETTI Service Bulletin 07322-27-01, dated December 21, 2004; Linear Motion Service Bulletin 7901708, Revision A, dated July 26, 2005; Boeing 737 Service Bulletin 27-1046, Revision 1, dated April 5, 1974; and/or SKYTRONICS Service Bulletin 93004, dated September 1, 2005, as applicable, as additional sources of service information for accomplishing the specified actions. Inspections, Lubrications, Repairs/Overhauls, and Applicable Corrective Actions
(g)At the applicable compliance time and repeat intervals listed in Tables 1 and 2 of paragraph 1.E., “Compliance,” of the service bulletin, do the inspections, lubrications, repairs/overhauls, installation(s), and applicable corrective actions by accomplishing all the applicable actions specified in the Accomplishment Instructions of the service bulletin; except as provided by paragraphs (g)(1) through (g)(3) of this AD.
(1)Where paragraph 1.E., “Compliance,” of the service bulletin specifies an initial compliance time for accomplishing the initial inspection, lubrication, or repair/overhaul, this AD requires doing the applicable initial action(s) at the later of the times specified in paragraphs (g)(1)(i) and (g)(1)(ii) of this AD.
(i)At the applicable compliance time specified in paragraph 1.E., “Compliance,” of the service bulletin.
(ii)Within the applicable compliance time specified in paragraph (g)(1)(ii)(A), (g)(1)(ii)(B), or (g)(1)(ii)(C) of this AD.
(A)For the initial detailed inspection and lubrication: Within 6 months after the effective date of this AD.
(B)For the initial repair/overhaul: Within 12 months after the effective date of this AD.
(C)For the installation(s): Within 12 months after the effective date of this AD.
(2)Where Table 2 of paragraph 1.E., “Compliance,” of Boeing Alert Service Bulletin 737-27A1277, Revision 1, dated July 25, 2007, specifies a compliance time of “* * * within 25,000 Flight Hours since the latest horizontal stabilizer trim actuator
(HSTA)Overhaul from the date of Revision 1 of this Service Bulletin * * *,” this AD requires compliance “* * * within 25,000 flight hours since the last overhaul of the trim actuator of the horizontal stabilizer.”
(3)Where Work Package 4, paragraphs 1.a., 2.a., and 3.a., of the Accomplishment Instructions of Boeing Alert Service Bulletin 737-27A1278, dated May 24, 2007, specifies to identify the HSTA name plate “* * * AS GIVEN IN SB 737-27A1278, WORK PACKAGE 3,” this AD requires that identification “ * * * AS GIVEN IN SB 737-27A1278, WORK PACKAGE 4.”
(4)Where Note
(b)of Figures 7 through 9 of Boeing Alert Service Bulletin 737-27A1278, dated May 24, 2007, specifies to do a “* * * Backlash Inspection as given in AMM 27-41-81/606,” this AD requires an “* * * End Play Test as given in OHM 27-45-11 page 701.”
(h)Actions done before the effective date of this AD in accordance with Boeing Alert Service Bulletin 737-27A1277, dated July 21, 2005, are acceptable for compliance with the corresponding requirements of this AD. Alternative Methods of Compliance (AMOCs) (i)(1) The Manager, Seattle Aircraft Certification Office, FAA, ATTN: Kelly McGuckin, Aerospace Engineer, Systems and Equipment Branch, ANM-130S, FAA, Seattle Aircraft Certification Office, 1601 Lind Avenue, SW., Renton, Washington 98057-3356; telephone
(425)917-6490; fax
(425)917-6590; has the authority to approve AMOCs for this AD, if requested using the procedures found in 14 CFR 39.19.
(2)To request a different method of compliance or a different compliance time for this AD, follow the procedures in 14 CFR 39.19. Before using any approved AMOC on any airplane to which the AMOC applies, notify your appropriate principal inspector
(PI)in the FAA Flight Standards District Office (FSDO), or lacking a PI, your local FSDO. Issued in Renton, Washington, on April 17, 2008. Ali Bahrami, Manager, Transport Airplane Directorate, Aircraft Certification Service. [FR Doc. E8-9193 Filed 4-25-08; 8:45 am] BILLING CODE 4910-13-P DEPARTMENT OF TRANSPORTATION Federal Aviation Administration 14 CFR Part 39 [Docket No. FAA-2008-0414; Directorate Identifier 2007-NM-095-AD] RIN 2120-AA64 Airworthiness Directives; Boeing Model 747-100, 747-100B, 747-100B SUD, 747-200B, 747-200C, 747-200F, 747-300, 747-400, 747-400D, 747-400F, and 747SR Series Airplanes AGENCY: Federal Aviation Administration (FAA), Department of Transportation (DOT). ACTION: Notice of proposed rulemaking (NPRM). SUMMARY: The FAA proposes to supersede an existing airworthiness directive
(AD)that applies to certain Boeing Model 747 series airplanes. The existing AD currently requires repetitive inspections for cracking and corrosion of all exposed surfaces of the carriage spindles (including the inner bore and aft links) of the trailing edge flaps, and additional inspection and corrective action if necessary. The existing AD also requires repetitive overhaul of the carriage spindle and aft link, which terminates the repetitive inspections. This proposed AD would add a repetitive inspection to detect broken parts, and revise the overhaul threshold and repetitive intervals. This proposed AD results from analysis that showed additional inspections should be done to prevent the loss of a flap, and that the flight-hour-based interval should be revised to a flight-cycle-based interval, because the greatest loads on the spindles happen during takeoff and landing. We are proposing this AD to detect and correct failed carriage spindles or aft links for the inboard or outboard trailing edge flaps. Such failure could cause the flap to depart the airplane, reducing the flightcrew's ability to maintain the safe flight and landing of the airplane. DATES: We must receive comments on this proposed AD by June 12, 2008. ADDRESSES: You may send comments by any of the following methods: • *Federal eRulemaking Portal:* Go to *http://www.regulations.gov.* Follow the instructions for submitting comments. • *Fax:* 202-493-2251. • *Mail:* U.S. Department of Transportation, Docket Operations, M-30, West Building Ground Floor, Room W12-140, 1200 New Jersey Avenue SE., Washington, DC 20590. • *Hand Delivery:* U.S. Department of Transportation, Docket Operations, M-30, West Building Ground Floor, Room W12-140, 1200 New Jersey Avenue, SE., Washington, DC 20590, between 9 a.m. and 5 p.m., Monday through Friday, except Federal holidays. For service information identified in this AD, contact Boeing Commercial Airplanes, P.O. Box 3707, Seattle, Washington 98124-2207. Examining the AD Docket You may examine the AD docket on the Internet at *http://www.regulations.gov* ; or in person at the Docket Management Facility between 9 a.m. and 5 p.m., Monday through Friday, except Federal holidays. The AD docket contains this proposed AD, the regulatory evaluation, any comments received, and other information. The street address for the Docket Office (telephone 800-647-5527) is in the ADDRESSES section. Comments will be available in the AD docket shortly after receipt. FOR FURTHER INFORMATION CONTACT: Gary Oltman, Aerospace Engineer, Airframe Branch, ANM-120S, FAA, Seattle Aircraft Certification Office, 1601 Lind Avenue, SW., Renton, Washington 98057-3356; telephone
(425)917-6443; fax
(425)917-6590. SUPPLEMENTARY INFORMATION: Comments Invited We invite you to send any written relevant data, views, or arguments about this proposed AD. Send your comments to an address listed under the ADDRESSES section. Include “Docket No. FAA-2008-0414; Directorate Identifier 2007-NM-095-AD” at the beginning of your comments. We specifically invite comments on the overall regulatory, economic, environmental, and energy aspects of this proposed AD. We will consider all comments received by the closing date and may amend this proposed AD because of those comments. We will post all comments we receive, without change, to *http://www.regulations.gov* , including any personal information you provide. We will also post a report summarizing each substantive verbal contact we receive about this proposed AD. Discussion On August 6, 1990, we issued AD 90-17-19, amendment 39-6705 (55 FR 33280, August 15, 1990), for all Boeing Model 747 series airplanes, except the Model 747SP. That AD requires repetitive inspections for cracking and corrosion of all exposed surfaces of the carriage spindles (including the inner bore and aft links) of the trailing edge flaps, and additional inspection and corrective action if necessary. The existing AD also requires repetitive overhaul of the carriage spindle and aft link, which terminates the repetitive inspections. That AD resulted from a report of failure of two aft links in the spindles on one flap, causing control problems during approach and landing. We issued that AD to prevent failure of the trailing edge flaps' carriage spindles, which could result in reduced controllability of the airplane. Actions Since Existing AD Was Issued Since we issued AD 90-17-19, the manufacturer conducted a dynamic aerodynamic analysis, which showed that the airplane might not have sufficient roll authority to overcome loss of lift caused by a departure of a single left- or right-hand inboard or outboard trailing edge flap. The manufacturer then conducted a structural analysis of the flap attach structure and fail-safe components, which showed that additional inspections should be done to prevent the loss of a flap, and that the flight-hour-based interval required by AD 90-17-19 should be revised to a flight-cycle-based interval because the greatest loads on the spindles happen during takeoff and landing and not during flight. Relevant Service Information We have reviewed Boeing Service Bulletin 747-27-2280, Revision 6, dated February 14, 2008. We referred to Boeing Service Bulletin 747-27-2280, Revision 3, dated November 30, 1989, as the appropriate source of service information for accomplishing the actions required by AD 90-17-19. Revision 6 adds a repetitive inspection of all eight carriage spindles and aft links to detect a broken carriage spindle or aft link, and corrective action if necessary. The remaining procedures in Revision 6 of the service bulletin are unchanged from Revision 3 of the service bulletin. The corrective action is replacing the broken part before further flight. Revision 6 of the service bulletin also revises the overhaul threshold and the repetitive overhaul interval as follows (AD 90-17-19 required the repetitive overhaul): • The initial overhaul threshold is the earlier of 8 years or a specified number of flight cycles. The number of flight cycles is either 6,000 or 9,000, depending on the airplane group specified in the service bulletin and the type and location of carriage originally installed. • The repetitive overhaul interval is also the earlier of 8 years or the same specified number of flight cycles based on the same variables. We have also reviewed Boeing Service Bulletin 747-27-2371, dated December 20, 2000, which applies only to Group 1 and Group 3 airplanes identified in Boeing Service Bulletin 747-27-2280, Revision 6. Boeing Service Bulletin 747-27-2371 describes procedures for replacing the link assemblies with new link assemblies made from improved corrosion-resistant steel
(CRES)that has a bearing race that is machined into the link. Doing this replacement eliminates the need for the repetitive overhauls specified in Boeing Service Bulletin 747-27-2280, Revision 6, for that aft link only. Accomplishing the actions specified in the service information is intended to adequately address the unsafe condition. FAA's Determination and Requirements of the Proposed AD We have evaluated all pertinent information and identified an unsafe condition that is likely to develop on other airplanes of the same type design. For this reason, we are proposing this AD, which would supersede AD 90-17-19 and would retain certain requirements of the existing AD at revised intervals. This proposed AD would also require a repetitive inspection to detect a broken carriage spindle or broken aft link, and corrective action if necessary. The proposed AD would also include, for certain airplanes, procedures for replacing the link assemblies with new link assemblies made from improved CRES that has a bearing race that is machined into the link, which would end the need for the repetitive overhauls specified in Boeing Service Bulletin 747-27-2280, Revision 6, for that aft link only. Changes to Existing AD This proposed AD would retain certain requirements of AD 90-17-19. Since AD 90-17-19 was issued, the AD format has been revised, and certain paragraphs have been rearranged. As a result, the corresponding paragraph identifiers have changed in this proposed AD, as listed in the following table: Revised Paragraph Identifiers Requirement in AD 90-17-19 Corresponding requirement in this proposed AD paragraph A. paragraph (f). paragraph A.1. paragraph (f). paragraph A.2. paragraph (f)(1). paragraph A.3. paragraph (f)(2). paragraph A.4. paragraph (f)(3). paragraph A.5. paragraph (f)(4). paragraph B. paragraph (g). We have revised paragraph A.5. of AD 90-17-19 (paragraph (f)(4) of this proposed AD) to allow any part of both carriage spindle/aft link assemblies to be repaired according to data that conform to the airplane's type certificate and that are approved by an Authorized Representative for the Boeing Commercial Airplanes Delegation Option Authorization Organization whom we have authorized to make such findings. In this proposed AD, the “detailed visual inspection” specified in AD 90-17-19 is referred to as a “detailed inspection.” We have included the definition for a detailed inspection in Note 1 of the proposed AD. We have also included the definition of a general visual inspection in Note 2 of this AD. That definition was not included in AD 90-17-19. Costs of Compliance There are about 925 airplanes of the affected design in the worldwide fleet, which includes 160 airplanes of U.S. registry. The following table provides the estimated costs for U.S. operators to comply with this proposed AD. The average labor rate is $80 per work hour. Estimated Costs Action Work hours Parts Cost per airplane Fleet cost Inspection and overhaul (required by AD 90-17-19) Between 120 and 140, per flap per cycle $0 Between $9,600 and $11,200, per flap per overhaul cycle Between $1,536,000 and $1,792,000, per flap per cycle. Repetitive inspection for broken parts (new proposed action) 2, per inspection cycle 0 $160, per inspection cycle $25,600, per inspection cycle. Authority for This Rulemaking Title 49 of the United States Code specifies the FAA's authority to issue rules on aviation safety. Subtitle I, Section 106, describes the authority of the FAA Administrator. Subtitle VII, Aviation Programs, describes in more detail the scope of the Agency's authority. We are issuing this rulemaking under the authority described in Subtitle VII, Part A, Subpart III, Section 44701, “General requirements.” Under that section, Congress charges the FAA with promoting safe flight of civil aircraft in air commerce by prescribing regulations for practices, methods, and procedures the Administrator finds necessary for safety in air commerce. This regulation is within the scope of that authority because it addresses an unsafe condition that is likely to exist or develop on products identified in this rulemaking action. Regulatory Findings We have determined that this proposed AD would not have federalism implications under Executive Order 13132. This proposed AD would not have a substantial direct effect on the States, on the relationship between the national Government and the States, or on the distribution of power and responsibilities among the various levels of government. For the reasons discussed above, I certify that the proposed regulation: 1. Is not a “significant regulatory action” under Executive Order 12866; 2. Is not a “significant rule” under the DOT Regulatory Policies and Procedures (44 FR 11034, February 26, 1979); and 3. Will not have a significant economic impact, positive or negative, on a substantial number of small entities under the criteria of the Regulatory Flexibility Act. We prepared a regulatory evaluation of the estimated costs to comply with this proposed AD and placed it in the AD docket. See the ADDRESSES section for a location to examine the regulatory evaluation. List of Subjects in 14 CFR Part 39 Air transportation, Aircraft, Aviation safety, Safety. The Proposed Amendment Accordingly, under the authority delegated to me by the Administrator, the FAA proposes to amend 14 CFR part 39 as follows: PART 39—AIRWORTHINESS DIRECTIVES 1. The authority citation for part 39 continues to read as follows: Authority: 49 U.S.C. 106(g), 40113, 44701. § 39.13 [Amended] 2. The Federal Aviation Administration
(FAA)amends § 39.13 by removing amendment 39-6705 (55 FR 33280, August 15, 1990) and adding the following new airworthiness directive (AD): **Boeing:** Docket No. FAA-2008-0414; Directorate Identifier 2007-NM-095-AD. Comments Due Date
(a)The FAA must receive comments on this AD action by June 12, 2008. Affected ADs
(b)This AD supersedes AD 90-17-19. Applicability
(c)This AD applies to all Boeing Model 747-100, 747-100B, 747-100B SUD, 747-200B, 747-200C, 747-200F, 747-300, 747-400, 747-400D, 747-400F, and 747SR series airplanes, certificated in any category. Unsafe Condition
(d)This AD results from analysis that showed that additional inspections should be done to prevent the loss of a flap, and that the flight-hour-based interval should be revised to a flight-cycle-based interval, because the greatest loads on the spindles happen during takeoff and landing. We are issuing this AD to detect and correct failed carriage spindles or aft links for the inboard or outboard trailing edge flaps. Such failure could cause the flap to depart the airplane, reducing the flightcrew's ability to maintain the safe flight and landing of the airplane. Compliance
(e)You are responsible for having the actions required by this AD performed within the compliance times specified, unless the actions have already been done. Requirements of AD 90-17-19 Repetitive Inspections
(f)For all airplanes except those airplanes on which the repetitive overhauls required by paragraph B. of AD 90-17-19 are being accomplished as of the effective date of this AD: Prior to the accumulation of 30,000 flight hours or 8 years on each new or previously overhauled flap carriage spindle, whichever occurs first, remove the aft link and thrust collars from the trailing edge flaps' carriage spindles and perform a detailed inspection of all exposed surfaces of the carriage spindles, including inner bore, and aft links to detect cracking and corrosion, in accordance with the Accomplishment Instructions of Boeing Service Bulletin 747-27-2280, Revision 3, dated November 30, 1989. Note 1: For the purposes of this AD, a detailed inspection is: “An intensive examination of a specific item, installation, or assembly to detect damage, failure, or irregularity. Available lighting is normally supplemented with a direct source of good lighting at an intensity deemed appropriate. Inspection aids such as mirror, magnifying lenses, etc., may be necessary. Surface cleaning and elaborate procedures may be required.”
(1)If no cracking or corrosion is found, repeat the inspections required by paragraph
(f)of this AD at intervals not to exceed 12 months until the carriage spindles are overhauled in accordance with paragraph
(g)of this AD.
(2)If a cracked carriage spindle or aft link is found, prior to further flight, replace the part(s) in accordance with the service bulletin.
(3)If corrosion is found on any part of the carriage spindle/aft link assembly, but not on the other assembly on the same flap, perform a repetitive general visual inspection in accordance with the service bulletin at intervals not to exceed 2 months. Overhaul or replace corroded parts in accordance with the service bulletin within 36 months after detection of the corrosion.
(4)If corrosion is found on any part of both carriage spindle/aft link assemblies on the same flap, prior to further flight, overhaul or replace the part(s) in accordance with the service bulletin or repair in accordance with the procedures specified in paragraph
(m)of this AD. Note 2: For the purposes of this AD, a general visual inspection is: “A visual examination of an interior or exterior area, installation, or assembly to detect obvious damage, failure, or irregularity. This level of inspection is made from within touching distance unless otherwise specified. A mirror may be necessary to ensure visual access to all surfaces in the inspection area. This level of inspection is made under normally available lighting conditions such as daylight, hangar lighting, flashlight, or droplight and may require removal or opening of access panels or doors. Stands, ladders, or platforms may be required to gain proximity to the area being checked.” Initial and Repetitive Overhauls
(g)*For all airplanes:* Prior to the accumulation of 8 years or 30,000 flight hours on any new or previously overhauled flap carriage spindle, whichever occurs later, remove the carriage spindle and aft link, and overhaul in accordance with the Accomplishment Instructions of Boeing Service Bulletin 747-27-2280, Revision 3, dated November 30, 1989. Repeat the overhaul thereafter at intervals not to exceed 8 years or 30,000 flight hours, whichever occurs earlier. Accomplishment of initial overhaul required by this paragraph terminates the requirements of paragraph
(f)of this AD. New Requirements of This AD Terminating Requirements
(h)The actions specified in paragraphs
(i)and
(j)of this AD must be accomplished in their entirety, at the specified compliance times, to terminate the requirements of paragraphs
(f)and
(g)of this AD. There is no terminating action for the requirements of paragraphs
(i)and
(j)of this AD. Repetitive Inspection for Broken Parts
(i)*For all airplanes:* Within 12 months or 400 flight cycles after the effective date of this AD, whichever occurs earlier, do a general visual inspection of all eight carriage spindles and aft links to detect a broken carriage spindle or broken aft link, and do all applicable corrective actions before further flight. Repeat the inspection thereafter at intervals not to exceed 400 flight cycles. Do all actions in accordance with the Accomplishment Instructions of Boeing Service Bulletin 747-27-2280, Revision 6, dated February 14, 2008. For airplanes identified in Note
(d)of Table 1 in paragraph 1.E., “Compliance,” of Boeing Service Bulletin 747-27-2280, Revision 6, dated February 14, 2008, the initial compliance time and repetitive interval for a flap may be extended to 1,000 flight cycles when new carriages are installed at both the inboard and outboard carriage locations on the flap. Repetitive Overhauls
(j)*For all airplanes:* At the later of the times specified in paragraph (j)(1) or (j)(2) of this AD, remove the carriage spindle and aft link, and overhaul in accordance with the Accomplishment Instructions of Boeing Service Bulletin 747-27-2280, Revision 6, dated February 14, 2008. Repeat the overhaul thereafter at the applicable repeat interval specified in paragraph 1.E., “Compliance,” of Boeing Service Bulletin 747-27-2280, Revision 6, dated February 14, 2008.
(1)The applicable threshold specified in paragraph 1.E. “Compliance,” of Boeing Service Bulletin 747-27-2280, Revision 6, dated February 14, 2008.
(2)Within 48 months after the effective date of this AD. Optional Terminating Action
(k)For Groups 1 and 3 airplanes identified in Boeing Service Bulletin 747-27-2280, Revision 6, dated February 14, 2008: Replacing the existing 4340M aft link with a new corrosion resistant steel
(CRES)aft link in accordance with the Accomplishment Instructions of Boeing Service Bulletin 747-27-2371, dated December 20, 2000, terminates the repetitive inspection requirements of paragraph
(f)of this AD, and the repetitive overhaul requirements of paragraphs
(g)and
(j)of this AD for that aft link only. The repetitive inspections for broken parts required by paragraph
(i)of this AD cannot be terminated. Credit for Previous Revision of Service Bulletin
(l)Actions done before the effective date of this AD in accordance with Boeing Service Bulletin 747-27-2280, Revision 4, dated April 26, 2001, are acceptable for compliance with the corresponding requirements of paragraphs
(f)and
(g)of this AD. Actions done before the effective date of this AD in accordance with Boeing Service Bulletin 747-27-2280, Revision 5, dated April 5, 2007, are acceptable for compliance with the corresponding requirements of paragraphs
(i)and
(j)of this AD. Alternative Methods of Compliance (AMOCs) (m)(1) The Manager, Seattle Aircraft Certification Office (ACO), FAA, has the authority to approve AMOCs for this AD, if requested in accordance with the procedures found in 14 CFR 39.19.
(2)To request a different method of compliance or a different compliance time for this AD, follow the procedures in 14 CFR 39.19. Before using any approved AMOC on any airplane to which the AMOC applies, notify your appropriate principal inspector
(PI)in the FAA Flight Standards District Office (FSDO), or lacking a PI, your local FSDO.
(3)AMOCs approved previously in accordance with AD 90-17-19 are approved as AMOCs for the corresponding provisions of this AD.
(4)Adjustments to the compliance times approved previously in accordance with AD 90-17-19 are not approved for the corresponding provisions of this AD.
(5)An AMOC that provides an acceptable level of safety may be used for any repair required by this AD, if it is approved by an Authorized Representative for the Boeing Commercial Airplanes Delegation Option Authorization Organization who has been authorized by the Manager, Seattle ACO, to make those findings. For a repair method to be approved, the repair must meet the certification basis of the airplane, and the approval must specifically refer to this AD. Issued in Renton, Washington, on April 18, 2008. Ali Bahrami, Manager, Transport Airplane Directorate, Aircraft Certification Service. [FR Doc. E8-9122 Filed 4-25-08; 8:45 am] BILLING CODE 4910-13-P FEDERAL TRADE COMMISSION 16 CFR Part 23 Guides for the Jewelry, Precious Metals, and Pewter Industries AGENCY: Federal Trade Commission (FTC or Commission) ACTION: Extension of deadline for submission of public comments. SUMMARY: The FTC is extending the deadline for filing public comments on a proposed amendment to the platinum section of the Guides for the Jewelry, Precious Metals, and Pewter Industries for an additional ninety
(90)days. DATES: Written comments must be received on or before August 25, 2008. ADDRESSES: Interested parties are invited to submit written comments. Comments should refer to “Jewelry Guides, Matter No. G711001” to facilitate the organization of comments. A comment filed in paper form should include this reference both in the text and on the envelope, and should be mailed or delivered, with two copies, to the following address: Federal Trade Commission/Office of the Secretary, Room 135-H (Annex E), 600 Pennsylvania Avenue, N.W., Washington, D.C. 20580. If the comment contains any material for which confidential treatment is requested, it must be filed in paper (rather than electronic) form, and the first page of the document must be clearly labeled “Confidential.” 1 The FTC is requesting that any comment filed in paper form be sent by courier or overnight service, if possible, because U.S. postal mail in the Washington area, and at the Commission, is subject to delay due to heightened security precautions. 1 Commission Rule 4.2(d), 16 CFR 4.2 (d). The comment must be accompanied by an explicit request for confidential treatment, including the factual and legal basis for the request, and must identify the specific portions of the comment to be withheld from the public record. The request will be granted or denied by the Commission’s General Counsel, consistent with applicable law and the public interest. *See* Commission Rule 4.9(c), 16 CFR 4.9(c). Because U.S. postal mail is subject to delay due to heightened security measures, please consider submitting your comments in electronic form. Comments filed in electronic form (except comments containing any confidential material) should be submitted by clicking on the following: *https://secure.commentworks.com/ftc-jewelry* and following the instructions on the web-based form. To ensure that the Commission considers an electronic comment, you must file it on the web-based form at *https://secure.commentworks.com/ftc-jewelry* . If this Notice appears at *http://www.regulations.gov* , you may also file an electronic comment through that website. The Commission will consider all comments that regulations.gov forwards to it. The FTC Act and other laws the Commission administers permit the collection of public comments to consider and use in this proceeding as appropriate. The Commission will consider all timely and responsive public comments that it receives, whether filed in paper or electronic form. Comments will be available to the public on the FTC website, to the extent practicable, at *http://www.ftc.gov.* As a matter of discretion, the FTC makes every effort to remove home contact information for individuals from the public comments it receives before placing those comments on the FTC website. More information, including routine uses permitted by the Privacy Act, may be found in the FTC's privacy policy at *http://www.ftc.gov/ftc/privacy.htm* . FOR FURTHER INFORMATION CONTACT: Robin Rosen Spector, Attorney,
(202)326-3740, or Janice Podoll Frankle, Attorney,
(202)326-3022, Division of Enforcement, Bureau of Consumer Protection, Federal Trade Commission, 600 Pennsylvania Avenue, N.W., Washington, D.C. 20580. SUPPLEMENTARY INFORMATION: On February 26, 2008, the Commission published a request for comment on a proposed amendment to the platinum section of the Guides for the Jewelry, Precious Metals, and Pewter Industries 2 (Jewelry Guides or Guides). The proposed amendment provides guidance on how to mark or describe non-deceptively products that contain at least 500 parts per thousand, but less than 850 parts per thousand, pure platinum and do not contain at least 950 parts per thousand platinum group metals. The Commission also sought comment on whether it should revise the Guides to provide guidance on how to mark or describe platinum-clad, filled, plated, or overlay products. The notice designated May 27, 2008 as the deadline for filing public comments. 2 73 FR 10190 (February 26, 2008). Two trade associations that represent jewelry industry members, Platinum Guild International
(PGI)and Jewelers Vigilance Committee (JVC), request a 90-day extension of the comment period. The associations explain that the Commission requested responses to 19 questions, that include over 20 subparts, and expressly requested submission of empirical data. 3 PGI states that the current deadline does not provide sufficient time to develop its comments and generate data to address the questions. JVC explains that the current period does not allow sufficient time for its Platinum Task Force 4 to collect the information required to fully address the issues. 3 The notice includes 19 questions that have 27 sub-parts. *Id.* 4 The JVC co-chairs this task force with two other industry trade associations, Manufacturing Jewelers and Suppliers of America and Jewelers of America. Karat Platinum LLC, a marketer of platinum/base metal alloys, filed a comment opposing the request for extension. Karat Platinum asserts that additional time is not needed in order to fully and completely respond to the Commission’s request for comment and that a delay will perpetuate market confusion. Karat Platinum states that the issues surrounding the appropriate terminology for this alloy are not new and many of the questions in the request for comment overlap with those posed in the Commission’s 2005 FRN requesting comment on this issue. 5 5 70 FR 38836 (July 6, 2005). The Commission is mindful of the need to deal with this matter expeditiously. However, the Commission also recognizes that its proposal raises complex issues and believes that extending the comment period to facilitate the creation of a more complete record outweighs any harm that might result from any delay. Accordingly, the Commission has decided to extend the comment period to August 25, 2008. By direction of the Commission. Donald S. Clark, Secretary. [FR Doc. E8-9171 Filed 4-25-08: 8:45 am] [Billing Code 6750-01-S] DEPARTMENT OF ENERGY Federal Energy Regulatory Commission 18 CFR Part 38 [Docket No. RM05-5-005] Standards for Business Practices and Communication Protocols for Public Utilities Issued April 21, 2008. AGENCY: Federal Energy Regulatory Commission, DOE. ACTION: Notice of proposed rulemaking. SUMMARY: The Federal Energy Regulatory Commission (Commission) proposes to incorporate by reference in its regulations the latest version (Version 001) of certain standards adopted by the Wholesale Electric Quadrant
(WEQ)of the North American Energy Standards Board (NAESB). NAESB's standards revise its Open Access Same-Time Information Systems (OASIS) business practice standards and four business practice standards relating to reliability issues, add new standards on transmission loading relief for the Eastern Interconnection and public key infrastructure, and add a new OASIS implementation guide. DATES: Comments on the proposed rule are due May 28, 2008. ADDRESSES: You may submit comments identified by Docket No. RM05-5-005, by one of the following methods: • *Agency Web site: http://ferc.gov.* Follow the instructions for submitting comments via the eFiling link found in the Comment Procedures Section of the preamble. • *Mail:* Commenters unable to file comments electronically must mail or hand deliver an original and 14 copies of their comments to the Federal Energy Regulatory Commission, Secretary of the Commission, 888 First Street, NE., Washington, DC 20426. Please refer to the Comment Procedures Section of the preamble for additional information on how to file paper comments. FOR FURTHER INFORMATION CONTACT: Gary D. Cohen (legal issues), Office of the General Counsel, Federal Energy Regulatory Commission, 888 First Street, NE., Washington, DC 20426,
(202)502-8321. Kay Morice (technical issues), Office of Energy Market Regulation, Federal Energy Regulatory Commission, 888 First Street, NE., Washington, DC 20426,
(202)502-6507. Ryan M. Irwin (technical issues), Office of Energy Market Regulation, Federal Energy Regulatory Commission, 888 First Street, NE., Washington, DC 20426,
(202)502-6454. SUPPLEMENTARY INFORMATION: 1. The Federal Energy Regulatory Commission (Commission) proposes to amend its regulations under the Federal Power Act 1 to incorporate by reference the latest version (Version 001) of certain business practice standards concerning the Open Access Same-Time Information Systems (OASIS) and four business practice standards relating to reliability issues adopted by the Wholesale Electric Quadrant
(WEQ)of the North American Energy Standards Board (NAESB). These revised standards update earlier versions of these standards that the Commission previously incorporated by reference into its regulations at 18 CFR 38.2 in Order Nos. 676 and 676-B. 2 In addition, we propose to incorporate by reference NAESB's new standards on transmission loading relief for the Eastern Interconnection and public key infrastructure, and add a new OASIS implementation guide. 1 16 U.S.C. 791a, *et seq.* 2 *Standards for Business Practices and Communication Protocols for Public Utilities,* Order No. 676, 71 FR 26199 (May 4, 2006), FERC Stats. & Regs., Regulations Preambles ¶ 31,216 (Apr. 25, 2006), *reh'g denied,* Order No. 676-A, 116 FERC ¶ 61,255 (2006), Order No. 676-B, 72 FR 21095 (Apr. 30, 2007), FERC Stats. & Regs. ¶ 31,246 (Apr. 19, 2007). I. Background NAESB 2. NAESB is a non-profit standards development organization established in January 2002 that serves as an industry forum for the development and promotion of business practice standards that promote a seamless marketplace for wholesale and retail natural gas and electricity. 3 Since 1995, NAESB and its predecessor, the Gas Industry Standards Board, have been accredited members of the American National Standards Institute (ANSI), complying with ANSI's requirements that its standards reflect a consensus of the affected industries. 4 3 *See Standards for Business Practices and Communication Protocols for Public Utilities,* Notice of Proposed Rulemaking, 72 FR 8318 (Feb. 27, 2007), FERC Stats. & Regs. ¶ 32,612 at P 3 (Feb. 20, 2007). 4 *Id.* 3. NAESB's standards include business practices that streamline the transactional processes of the natural gas and electric industries, as well as communication protocols and related standards designed to improve the efficiency of communication within each industry. NAESB supports all four quadrants of the gas and electric industries—wholesale gas, wholesale electric, retail gas, and retail electric. All participants in the gas and electric industries are eligible to join NAESB and participate in standards development. 5 5 *Id.* at P 4. 4. NAESB's procedures are designed to ensure that all industry members can have input into the development of a standard, whether or not they are members of NAESB, and each standard NAESB adopts is supported by a consensus of the relevant industry segments. 6 6 *Id.* at P 5. Order Nos. 676 and 676-B 5. In Order No. 676, with certain specified exceptions, the Commission incorporated by reference into its regulations at 18 CFR 38.2 the Version 000 OASIS Business Practice Standards adopted by NAESB in January 2005. In Order No. 676, the Commission also incorporated by reference into its regulations at 18 CFR 38.2 NAESB's OASIS Standards & Communication Protocols, OASIS Data Dictionary and four business practice standards related to reliability issues. Specifically, the business practice standards related to reliability issues are: Coordinate Interchange, WEQ-004, Version 000; Area Control Error
(ACE)Equation Special Cases, WEQ-005, Version 000; Manual Time Error Correction, WEQ-006, Version 000; and Inadvertent Interchange Payback, WEQ-007, Version 000. 6. In Order No. 676, the Commission not only adopted business practice standards and communication protocols for the wholesale electric industry, it also established a formal ongoing process for reviewing and upgrading the Commission's OASIS standards and other wholesale electric industry business practice standards. 7 7 In developing the original OASIS standards and communications protocols adopted in Order No. 889, and revised in subsequent orders, the Commission enlisted the assistance of two *ad hoc* industry working groups (the “How” Group and the “What” Group) that developed proposals for OASIS standards and communications protocols that the Commission reviewed, modified where appropriate, and ultimately adopted as Commission regulations and requirements. *See Open Access Same-Time Information System (OASIS) and Standards of Conduct,* Order No. 889, 61 FR 21737 (May 10, 1996), FERC Stats. & Regs., Regulations Preambles January 1991-June 1996 ¶ 31,035 at 31,588-89 & n. 13 (Apr. 24, 1996). In Order No. 676, this informal process was replaced by the more formal NAESB process, where NAESB, as an ANSI-approved standards development organization, adopted standards and requirements that were then reported to the Commission to consider and, following public comment, incorporate by reference into its regulations, where appropriate. 7. In Order No. 676-B, the Commission incorporated by reference into its regulations at 18 CFR 38.2 the revised Coordinate Interchange Standards adopted by NAESB in June 2005. NAESB's Version 001 Report 8. On December 26, 2007, NAESB filed a report informing the Commission that the NAESB WEQ had ratified WEQ Version 001 of its standards. These standards include several modifications to the existing business practice standards that the Commission incorporated by reference in Order Nos. 676 and 676-B, as well as creating new standards to provide additional functionality for OASIS transactions, transmission loading relief for the Eastern Interconnection, and public key infrastructure. Some of the standards subsequently were corrected by the WEQ and these minor corrections were applied to the Version 001 standards on November 16, 2007. 8 NAESB's WEQ Version 001 includes the following standards: 8 The Version 001 standards do not include modifications of existing standards or new standards to support Order No. 890, the Commission's Final Rule amending the Commission's *pro forma* Open Access Transmission Tariff, *Preventing Undue Discrimination and Preference in Transmission Service,* 72 FR 12266 (Mar. 15, 2007), FERC Stats. & Regs. ¶ 31,241 (Feb. 16, 2007), *order on reh'g,* Order No. 890-A, 73 FR 2984 (Jan. 16, 2008), FERC Stats. & Regs. ¶ 31,261 (Dec. 28, 2007), *reh'g pending,* with the exception of modifications to resales and transfers to address the Commission's rules for resales described in Order No. 890 in P 815 and footnote 496. • Business Practices for Open Access Same-Time Information Systems (OASIS), Version 1.4 (WEQ-001); 9 9 The WEQ Version 001 package of standards includes Version 1.4 of the OASIS Standards. The reference to Version 1.4 is based on the fact that this is the fourth set of revisions to the Version 1.0 OASIS Standards that the Commission adopted in Order No. 889. The Version 1.4 reference appears in Standards WEQ-001, WEQ-002, WEQ-003, and WEQ-013. • Business Practices for Open Access Same-Time Information Systems (OASIS) Standards & Communications Protocols, Version 1.4 (WEQ-002); • OASIS Data Dictionary, Version 1.4 (WEQ-003); • Coordinate Interchange (WEQ-004); 10 10 In a Notice of Proposed Rulemaking (NOPR), being issued contemporaneously by the Commission in Docket No. RM08-7-000, the Commission proposes, pursuant to section 215 of the Federal Power Act, to approve six modified Reliability Standards submitted to the Commission for approval by the North American Electric Reliability Corporation (NERC). In the proceeding in Docket No. RM08-7-000, the Commission is addressing modified Reliability Standards, while in the instant proceeding, in Docket No. RM05-5-005, the Commission is addressing, among other matters, the business practice standards related to these Reliability Standards. Five of the modified Reliability Standards being addressed in the proceeding in Docket No. RM08-7-000 pertain to interchange scheduling and coordination and one pertains to transmission loading relief procedures. In addition, the Commission proposes, in the NOPR being issued in RM08-7-000, to approve NERC's proposed interpretation of five specific Requirements of Commission-approved Reliability Standards. • Area Control Error
(ACE)Equation Special Cases (WEQ-005); • Manual Time Error Correction (WEQ-006); • Inadvertent Interchange Payback (WEQ-007); • Transmission Loading Relief—Eastern Interconnection (WEQ-008); 11 11 *Id.* • Standards of Conduct for Electric Transmission Providers (WEQ-009); • Contracts Related Standards (WEQ-010); • Gas/Electric Coordination (WEQ-011); 12 12 These standards are identical to the standards the Commission incorporated by reference into its regulations at 18 CFR 38.2 in Order No. 698. *Standards for Business Practices for Interstate Natural Gas Pipelines; Standards for Business Practices for Public Utilities,* Order No. 698, 72 FR 38757 (July 16, 2007), FERC Stats. & Regs., Regulations Preambles 2006-2007 ¶ 31,251 (June 25, 2007), *order on clarification and reh'g,* Order No. 698-A, 121 FERC ¶ 61,264 (2007). • Public Key Infrastructure
(PKI)(WEQ-012); and • Business Practices for Open Access Same-Time Information Systems (OASIS) Implementation Guide, Version 1.4 (WEQ-013). II. Discussion 9. We propose generally to incorporate by reference the NAESB WEQ standards. 13 While many of the standards simply revise or update existing standards, some of the standards address new business practices. For example, NAESB adopted new business practice standards for Resales and Transfers to standardize secondary transmission service on OASIS. These standards also standardize how Resales and Transfers are conducted off OASIS. NAESB also adopted public key infrastructure standards to create greater security for business transactions taking place over the Internet. In addition, NAESB has revised and added standards establishing business practices related to the NERC reliability standards. 14 In particular, NAESB has adopted standards governing transmission loading relief
(TLR)that specify business practices for cutting transmission services in the event of a TLR, consistent with the NERC reliability standards. These standards are described more fully in the discussion below. 13 We do not propose to incorporate by reference in the Commission's regulations the following standards: Standards of Conduct for Electric Transmission Providers (WEQ-009) and Contracts Related Standards (WEQ-010). We do not propose to incorporate these standards into the Commission's regulations because WEQ-009 contains no substantive standards and merely serves as a placeholder for future standards while WEQ-010 contains an optional NAESB contract regarding funds transfers. The Commission does not require utilities to use such contracts and thus, the Commission does not propose to incorporate this standard by reference. In addition, as discussed more specifically in note 22, *infra,* we do not propose to incorporate by reference certain portions of WEQ-001. 14 *See* note 10, *supra.* 10. NAESB approved the standards under its consensus procedures. 15 Adoption of consensus standards is appropriate because the consensus process helps ensure the reasonableness of the standards by requiring that the standards draw support from a broad spectrum of all segments of the industry. Moreover, since the industry itself has to conduct business under these standards, the Commission's regulations should reflect those standards that have the widest possible support. In § 12(d) of the National Technology Transfer and Advancement Act of 1995 (NTT&AA), Congress affirmatively requires federal agencies to use technical standards developed by voluntary consensus standards organizations, like NAESB, as a means to carry out policy objectives or activities. 16 15 The WEQ's procedures ensure that all industry members can have input into the development of a business practice standard, whether or not they are members of NAESB, and each standard it adopts is supported by a consensus of the five industry segments: transmission, generation, marketer/brokers, distribution/load serving entities, and end users. Under the WEQ process, for a standard to be approved, it must receive a super-majority vote of 67 percent of the members of the WEQ's Executive Committee with support from at least 40 percent of each of the five industry segments. For final approval, 67 percent of the WEQ's general membership must ratify the standards. 16 Public Law No. 104-113, 12(d), 110 Stat. 775 (1996), 15 U.S.C. 272 note (1997). 11. The Commission is also proposing, consistent with our regulation at 18 CFR 35.28(c)(vi), to require each electric utility to revise its open access transmission tariff
(OATT)to include the Version 001 WEQ standards we are proposing to incorporate by reference herein. For standards that do not require implementing tariff provisions, the Commission is proposing to permit the utility to incorporate the WEQ standard by reference in its OATT. We are not, however, requiring a separate tariff filing to accomplish this change. Consistent with our prior practice, we are proposing to give public utilities the option of including these changes as part of an unrelated tariff filing. 17 However, consistent with our prior practice, we propose that, once the Commission incorporates these standards by reference into its regulations, public utilities must abide by these standards even before they have updated their tariffs to incorporate these changes. 17 *See* Order No. 676 at P 100. A. OASIS Standards 12. In Standards WEQ-001, WEQ-002, and WEQ-003, NAESB revises the OASIS Standards currently incorporated by reference by the Commission. More specifically, in Standard WEQ-001, NAESB adopts new standards addressing Resale and Transfer transactions 18 that are consistent with the Commission's policies articulated in Order No. 890. 19 18 NAESB defines a “Resale” as “[t]he request to convey scheduling rights associated with a reservation for Point-to-Point Transmission Service from a Reseller to an Assignee.” Standard WEQ-001.0.19. NAESB defines “Transfer” as a “[r]equest to convey *all* rights and obligations associated with a reservation for Point-to-Point Transmission Service from a Reseller to an Assignee.” Standard WEQ-001-0.20. 19 *See* Order No. 890, P 815 and n.496. 13. In Order No. 890, the Commission adopted reforms to its underlying rules governing capacity reassignments. Specifically, the Commission required that all sales or assignments of capacity be conducted through or otherwise posted on the transmission provider's OASIS on or before the date the reassigned service commences. 20 The Commission directed transmission providers (working through NAESB) to develop the appropriate OASIS functionality to allow such postings and stated that transmission providers need not implement this new OASIS functionality and any related business practices until NAESB develops appropriate standards. These business practices and functionality have now been adopted by NAESB in Standard WEQ-001. 20 *Id.* 14. The WEQ's Standard WEQ-002 creates a new business practice standard requiring a Standards of Conduct link on the OASIS in response to the Commission's NOPR that preceded Order No. 676. 21 In addition, WEQ Standard WEQ-002 divides the OASIS Standards and Communications Protocols Document (S&CP Document) into two documents, thus separating the technical requirements (which remain in WEQ-002) from the business requirements (now found in WEQ-013). The WEQ's Standard WEQ-003 revises the OASIS Data Dictionary to include minor clarifications or corrections to the format, appearance, or descriptions of standards in standards documentation, as well as corrections and minor revisions that did not materially change a standard. 21 The types of information accessible from this link include Emergency Circumstances Deviations, Marketing and Energy Affiliate List, Shared Facilities, Organizational Charts and Job Descriptions, Common Employees, Potential Merger Partners, Transfers, Information Disclosure, Voluntary Consent to Share Non-Affiliated Customer Information, Discretionary Actions Under Tariff, Discounts, Chief Compliance Officer, and Written Procedures for Implementation. 15. The WEQ's Standard WEQ-013 contains a new OASIS Implementation Guide. While this Standard condenses and incorporates the various OASIS S&CP Document business practices and requirements that formerly were found in WEQ-002 into a separate Implementation Guide, it makes no significant substantive changes to the prior standard. 16. In this NOPR, we propose to incorporate by reference all four of these OASIS-related business practice standards, as revised ( *i.e.* , Standards WEQ-001, WEQ-002, WEQ-003, and WEQ-013). 22 22 As we stated in Order No. 676, we are not proposing to incorporate by reference WEQ standards 001-0.1, 001-0.9 through 001-0.13, 001-1.0 through 001-1.8, and 001-9.7, because these standards merely restate Commission regulations and because standard 001-9.7 is not consistent with the Commission's policy on redirects. B. Public Key Infrastructure 17. In Version 001, NAESB has adopted new standards for secure communications over the public internet, Public Key Infrastructure
(PKI)23 (WEQ-012). These standards describe the requirements that Certification Authorities
(CAs)24 must meet to claim the electronic certificate that a CA issues meets the NAESB WEQ PKI Standards and to conform to the NAESB Certification Program and, thus, be considered an Authorized Certification Authority (Authorized CA). 25 Providing security for transactions across the public internet is an important part of supporting energy markets and system reliability functions. Therefore, we propose to update our regulations at 18 CFR 38.2 to incorporate by reference Standard WEQ-012. 23 This PKI mechanism occurs through the use of extremely long prime numbers, called keys. Two keys are involved—a private key, which only the user has access to, and a public key, which can be accessed by anyone. The two keys work together so a message scrambled with the private key can only be unscrambled with the public key and vice versa. The more digits in these keys, the more secure the process. Similar to proving an identity through a handwritten signature offline, a digital signature is used to prove an identity online. 24 A Certification Authority is a third-party entity that issues digital certificates used to create digital signatures and public-private key pairs. A Certification Authority plays a critical role in data security and electronic commerce since it is entrusted to guarantee that the two parties exchanging information are really who they claim to be. 25 On achieving NAESB certification, NAESB will provide NERC with the names of Authorized CAs. The Authorized CA may immediately display the NAESB certification mark and will be authorized to claim compliance with NAESB WEQ PKI Standards. All industry applications ( *e.g.* , OASIS) secured under these PKI Standards must permit access to any legitimate user that presents a valid electronic certificate issued by an Authorized CA. C. Business Standards to Coordinate With Reliability Standards 18. The WEQ has also adopted revisions to business practice standards addressing the business ramifications of certain reliability-related issues. 1. Coordinate Interchange 19. In Version 001 standards for Coordinate Interchange (WEQ-004), NAESB has made additional modifications to the Coordinate Interchange standards that the Commission incorporated by reference into its regulations in Order No. 676-B. 26 These modifications were made to account for a regional difference in the Western Electricity Coordinating Council regarding acceptable backup methods for creating a Request for Interchange, to provide for Purchasing-Selling Entity optional approval rights, to explain the terms “correctable” and “required,” to clarify that tag data elements may be “not correctable” or “not required,” and to make the element of “Energy Product Type” required. These modifications were made as a result of a joint effort of NERC and NAESB via the Joint Interchange Scheduling Working Group which is a committee of both NERC and NAESB participants. 26 The revised Coordinate Interchange standards were designed to facilitate the transfer of electric energy between entities responsible for balancing load and generation. Also, the revised Coordinate Interchange standards were intended to be compatible with the NERC Interchange Scheduling and Coordination Reliability Standards that the Commission approved in Order No. 693, *Mandatory Reliability Standards for the Bulk-Power System* , 72 FR 16416 (Apr. 4, 2007), FERC Stats. & Regs. ¶ 31,242, at P 961-65 (2007), *order on reh'g* , Order No. 693-A, 120 FERC ¶ 61,053 (2007). 20. We propose to update our regulations at 18 CFR 38.2 to incorporate by reference the Coordinate Interchange Standard WEQ-004, Version 001. However, we seek comment on two aspects of these standards. Standard 004-3.1 states that “[f]or Interchange where the sink is in the Western Interconnection for same day transactions, the last Purchasing-Selling Entity before the DC Tie in the Eastern Interconnection shall be responsible for submitting the e-Tag.” This standard identifies only the last Purchasing-Selling Entity before the DC Tie in the Eastern Interconnection as being responsible for submitting the e-Tag Interchange when the sink is in the Western Interconnection. However, we request comment on whether, based on the NERC standards, this standard also should address whether a Generator Owner or Load Serving Entity may schedule directly to the DC Tie owner. 21. Additionally, Standard 004-6.1.2 states that “[i]f the PSE, LSE, and GPE do not respond to a request from the Interchange Authority, the Interchange is considered passively approved.” While confirmation by silence is a common business practice eliminating unnecessary communications, we request comment on whether this is appropriate for a business practice intended to complement a reliability standard. 2. Area Control Error
(ACE)Equation Special Cases 22. In the Version 001 standards for Area Control Error
(ACE)Equation Special Cases (WEQ-005), NAESB has made only minor modifications to the standards to number the definitions and make other minor edits. We propose to update our regulations at 18 CFR 38.2 to incorporate by reference this revised standard in lieu of the current version of this standard. 3. Manual Time Error Correction 23. In the Version 001 standards for Manual Time Error Correction (WEQ-006), NAESB has made changes to remove references to the Electric Reliability Council of Texas (ERCOT), to make minor corrections to the standards for the Western Interconnection, and to make other minor modifications including numbering the definitions. We propose to update our regulations at 18 CFR 38.2 to incorporate by reference this revised standard in lieu of the current version of this standard. 4. Inadvertent Interchange Payback 24. In the Version 001 standards for Inadvertent Interchange Payback (WEQ-007), NAESB has made changes to remove references to ERCOT and make other minor modifications including numbering the definitions. We propose to update our regulations at 18 CFR 38.2 to incorporate by reference this revised standard in lieu of the current version of this standard. 5. Transmission Loading Relief 25. In Version 001, NAESB has adopted new standards for Transmission Loading Relief—Eastern Interconnection (WEQ-008). NAESB states that these business practice standards are intended to be complementary to the NERC reliability standards INT-004-1—Reliability Coordination—Operations Planning and INT-006-4—Reliability Coordination—Transmission Loading Relief. 27 NAESB reports that its Transmission Loading Relief
(TLR)business practice standards are the result of a multi-year joint effort of the NERC Transmission Loading Relief Drafting Team and the NAESB WEQ Business Practices Subcommittee to split the existing NERC Transmission Loading Relief reliability standards into reliability and business practice components. In addition, NAESB states that the NAESB WEQ TLR standards have been further modified to allow for regional differences for market flows. 28 The NAESB WEQ TLR standards include general requirements regarding the use of Interconnection-wide TLR procedures; 29 Interchange Transaction 30 priorities for use with Interconnection-wide TLR procedures; the Eastern Interconnection procedure for physical curtailment of Interchange Transactions; appendices with various examples; and an appendix specifying regional differences for PJM Interconnection, L.L.C./Midwest Independent System Operator, Inc. and for Southwest Power Pool. 27 NERC filed a petition seeking approval of its related proposed reliability standards, IRO-006-4—Reliability Coordination—Transmission Loading Relief, with the Commission in Docket No. RM08-7-000. We believe that NAESB's reference to INT-006-4 should be a reference to IRO-006-4. We also believe that the proper subject of INT-004-1 is “Dynamic Interchange Transaction Modifications,” rather than “Reliability Coordination—Operations Planning.” 28 Market flows are the calculated energy flows on a specified Flowgate as a result of the dispatch of generating resources within a Market-Based Operating Entity's market. NAESB defines “Flowgate” as a “designated point of the transmission system through which the Interchange Distribution Calculator calculates the power flow from Interchange Transactions.” The treatment of the market flows of regional transmission organizations compared with the treatment of generation-to-load impacts of non-market entities as they relate to the use of TLRs has been addressed by the Commission in a number of cases, including Order No. 693, FERC Stats. & Regs. ¶ 31,242 at P 987, *Alliance Companies* , 100 FERC ¶ 61,137
(2002)and *Midwest Independent Transmission System Operator, Inc. and PJM Interconnection, L.L.C.* , 106 FERC ¶ 61,251 (2004). 29 NAESB defines “Transmission Loading Relief”
(TLR)as “[a] procedure used in the Eastern Interconnection to relieve potential or actual loading on a Constrained Facility or Flowgate.” Standard WEQ-008-0.40. 30 NAESB defines an “Interchange Transaction” as “[a] transaction that crosses one or more Balancing Authorities’ boundaries. The planned energy exchange between two adjacent Balancing Authorities.” Standard WEQ-008-0.19. 26. The Commission seeks to ensure that the NAESB WEQ TLR business practice standards and the proposed NERC TLR reliability standard complement each other and can be implemented together harmoniously. Therefore, we propose to update our regulations at 18 CFR 38.2 to incorporate by reference Standard WEQ-008. We invite comment on this proposal. 27. While we understand that NAESB and NERC have worked collaboratively to coordinate their standard development efforts, there appear to be several occasions in the TLR standards in which the definitions used by the two depart. The following are some examples: 31 Glossary of Terms Used in Reliability Standards, *ftp://www.nerc.com/pub/sys/all_updl/standards/rs/Glossary_02Aug06.pdf.* NAESB definition NERC definition 31 Balancing Authority Area: [a]n electrical system bounded by Interconnection (tie-line) metering and telemetry, where the Balancing Authority controls (either directly or by contract) generation to maintain its Interchange Schedule with other Balancing Authority Areas and contributes to frequency regulation of the Interconnection Balancing Authority Area: [t]he collection of generation, transmission, and loads within the metered boundaries of the Balancing Authority. The Balancing Authority maintains load-resource balance within this area. Interchange Transaction: [a] transaction that crosses one or more Balancing Authorities' boundaries. The planned energy exchange between two adjacent Balancing Authorities Interchange Transaction: [a]n agreement to transfer energy from a seller to a buyer that crosses one or more Balancing Authority Area boundaries. Reliability Coordinator: [a]n entity that provides the security assessment and emergency operations coordination for a group of Balancing Authorities, Transmission Service Providers, and Transmission Operators Reliability Coordinator: [t]he entity that is the highest level of authority who is responsible for the reliable operation of the Bulk Electric System, has the Wide Area view of the Bulk Electric System, and has the operating tools, processes and procedures, including the authority to prevent or mitigate emergency operating situations in both next-day analysis and real-time operations. The Reliability Coordinator has the purview that is broad enough to enable the calculation of Interconnection Reliability Operating Limits, which may be based on the operating parameters of transmission systems beyond any Transmission Operator's vision. 28. There also appear to be some instances in various NAESB standards where the same term is defined differently. For example, the definition of Balancing Authority in Standard WEQ-004-0.3 is not identical to the definition of that same term in Standard WEQ-008-0.4. As the Commission stated in Order No. 676, the standards relating to reliability would be clearer if a single definition were used. Although in Order No. 676 the Commission generally found that NERC should take the lead in defining reliability-related terms, 32 we recognize that good reasons may exist in certain cases for some differences in these terms. We therefore request comment on whether the differences in definitions are significant and whether a single definition for reliability-related terms should be adopted in future standards. 32 Order No. 676 at P 40. III. Notice of Use of Voluntary Consensus Standards 29. The NAESB WEQ standards were adopted pursuant to NAESB's consensus procedures. 33 As the Commission found in Order No. 676, adoption of consensus standards is appropriate because the consensus process helps ensure the reasonableness of the standards by requiring that the standards draw support from a broad spectrum of all segments of the industry. Moreover, since the industry itself has to conduct business under these standards, the Commission's regulations should reflect those standards that have the widest possible support. In section 12(d) of the National Technology Transfer and Advancement Act of 1995, Congress affirmatively requires federal agencies to use technical standards developed by voluntary consensus standards organizations, like NAESB, as a means to carry out policy objectives or activities. 34 33 This process is described in note 15, *supra.* 34 Public Law 104-113, 12(d), 110 Stat. 775 (1996), 15 U.S.C. 272 note (1997). 30. Office of Management and Budget Circular A-119 (section 11) (February 10, 1998) provides that Federal Agencies should publish a request for comment in a NOPR when the agency is seeking to issue or revise a regulation proposing to adopt a voluntary consensus standard or a government-unique standard. In this NOPR, the Commission is proposing to incorporate by reference a voluntary consensus standard developed by the WEQ. IV. Information Collection Statement 31. The following collection(s) of information contained in this proposed rule have been submitted to the Office of Management and Budget
(OMB)for review under section 3507(d) of the Paperwork Reduction Act of 1995, 44 U.S.C. 3507(d). The Commission solicits comments on the Commission's need for this information, whether the information will have practical utility, the accuracy of the provided burden estimates, ways to enhance the quality, utility, and clarity of the information to be collected, and any suggested methods for minimizing respondents' burden, including the use of automated information techniques. Respondents subject to the filing requirements of this rule will not be penalized for failing to respond to these collections of information unless the collections of information display a valid OMB Control number. 32. The following burden estimate is based on the projected costs for the industry to implement revisions to the WEQ Standards currently incorporated by reference into the Commission's regulations at 18 CFR 38.2 and to implement the new standards adopted by NAESB that we propose here to incorporate by reference. Data collection Nunber of respondents Number of responses per respondent Hours per response Total number of hours FERC-516 176 1 6 1056 FERC-717 176 1 10 1760 Totals 2816 *Total Annual Hours for Collection:* (Reporting and Recordkeeping, (if appropriate)) = 2816 hours. *Information Collection Costs:* The Commission seeks comments on the costs to comply with these requirements. It has projected the average annualized cost for all respondents to be the following: 35 35 The total annualized costs for the information collection is $901,120. This number is reached by multiplying the total hours to prepare responses (2,816) by an hourly wage estimate of $320 (a composite estimate that includes legal, technical and support staff rates, $200 + $95 + $25=$320), 2,816 hours × $320/hour= $901,120. FERC-516 FERC-717 Annualized Capital/Startup Costs $337,920 $563,200 Annualized Costs (Operations & Maintenance) N/A Total Annualized Costs 337,920 563,200 33. OMB regulations 36 require OMB to approve certain information collection requirements imposed by agency rule. The Commission is submitting notification of this proposed rule to OMB. These information collections are mandatory requirements. 36 5 CFR 1320.11. *Title:* Standards for Business Practices and Communication Protocols for Public Utilities ( *formerly* Open Access Same Time Information System) (FERC-717); Electric Rate Schedule Filings (FERC-516). *Action:* Proposed collection. *OMB Control No.:* 1902-0096 (FERC-516); 1902-0173 (FERC-717). *Respondents:* Business or other for profit, (Public Utilities—Not applicable to small businesses.) *Frequency of Responses:* One-time implementation (business procedures, capital/start-up). *Necessity of the Information:* This proposed rule, if implemented would upgrade the Commission's current business practice and communication standards. Specifically, these standards include several modifications to the existing business practice standards as well as creating new standards to provide additional functionality for OASIS transactions, transmission loading relief and public key infrastructure. The standards will assist in providing greater security for business transactions over the Internet, identify the business practices to be used to relieve potential or actual loading on a constrained facility and facilitate the transfer of electric energy between entities responsible for balancing load and generation. These practices will ensure that potential customers of open access transmission service receive access to information that will enable them to obtain transmission service on a non-discriminatory basis and will assist the Commission in maintaining a safe and reliable infrastructure and also will assure the reliability of the interstate transmission grid. The implementation of these standards and regulations is necessary to increase the efficiency of the wholesale electric power grid. 34. The information collection requirements of this proposed rule are based on the transition from transactions being made under the Commission's existing business practice standards to conducting such transactions under the proposed revisions to these standards and to account for the burden associated with the new standard(s) being proposed here ( *i.e.,* WEQ-008 and WEQ-012). 35. *Internal Review:* The Commission has reviewed the revised business practice standards and has made a preliminary determination that the proposed revisions are necessary to maintain consistency between the business practice standards and reliability standards on this subject. The Commission has assured itself, by means of its internal review, that there is specific, objective support for the burden estimate associated with the information requirements. 36. Interested persons may obtain information on the reporting requirements by contacting the following: Federal Energy Regulatory Commission, Attn: Michael Miller, Office of the Executive Director, 888 First Street, NE., Washington, DC 20426, Tel:
(202)502-8415 / Fax:
(202)273-0873, E-mail: *michael.miller@ferc.gov* . 37. Comments concerning the collection of information(s) and the associated burden estimate(s), should be sent to the contact listed above and to the Office of Management and Budget, Office of Information and Regulatory Affairs, Washington, DC 20503 [ *Attention:* Desk Officer for the Federal Energy Regulatory Commission, phone:
(202)395-7856, fax:
(202)395-7285]. V. Environmental Analysis 38. The Commission is required to prepare an Environmental Assessment or an Environmental Impact Statement for any action that may have a significant adverse effect on the human environment. 37 The Commission has categorically excluded certain actions from these requirements as not having a significant effect on the human environment. 38 The actions proposed here fall within categorical exclusions in the Commission's regulations for rules that are clarifying, corrective, or procedural, for information gathering, analysis, and dissemination, and for sales, exchange, and transportation of electric power that requires no construction of facilities. 39 Therefore, an environmental assessment is unnecessary and has not been prepared in this NOPR. 37 Order No. 486, *Regulations Implementing the National Environmental Policy Act,* 52 FR 47897 (Dec. 17, 1987), FERC Stats. & Regs., Regulations Preambles 1986-1990 ¶30,783 (1987). 38 18 CFR 380.4. 39 *See* 18 CFR 380.4(a)(2)(ii), 380.4(a)(5), 380.4(a)(27). VI. Regulatory Flexibility Act Certification 39. The Regulatory Flexibility Act of 1980
(RFA)40 generally requires a description and analysis of final rules that will have significant economic impact on a substantial number of small entities. The regulations proposed here impose requirements only on public utilities, which are not small businesses, and, these requirements are, in fact, designed to benefit all customers, including small businesses. 40 5 U.S.C. 601-612. 40. The Commission has followed the provisions of both the RFA and the Paperwork Reduction Act on potential impact on small business and other small entities. Specifically, the RFA directs agencies to consider four regulatory alternatives to be considered in a rulemaking to lessen the impact on small entities: Tiering or establishment of different compliance or reporting requirements for small entities, classification, consolidation, clarification or simplification of compliance and reporting requirements, performance rather than design standards, and exemptions. As the Commission originally stated in Order No. 889, the OASIS regulations now known as Standards for Business Practices and Communication Protocols for Public Utilities, apply only to public utilities that own, operate, or control transmission facilities subject to the Commission's jurisdiction and should a small entity be subject to the Commission's jurisdiction, it may file for waiver of the requirements. This is consistent with the exemption provisions of the RFA. Accordingly, pursuant to section 605(b) of the RFA, 41 the Commission hereby certifies that the regulations proposed herein will not have a significant adverse impact on a substantial number of small entities. 41 5 U.S.C. 605(b). VII. Comment Procedures 41. The Commission invites interested persons to submit comments on the matters and issues proposed in this notice to be adopted, including any related matters or alternative proposals that commenters may wish to discuss. Comments are due May 28, 2008. Comments must refer to Docket No. RM05-5-005, and must include the commenter's name, the organization they represent, if applicable, and their address. Comments may be filed either in electronic or paper format. 42. Comments may be filed electronically via the eFiling link on the Commission's Web site at *http://www.ferc.gov* . The Commission accepts most standard word processing formats and commenters may attach additional files with supporting information in certain other file formats. Commenters filing electronically do not need to make a paper filing. Commenters that are not able to file comments electronically must send an original and 14 copies of their comments to: Federal Energy Regulatory Commission, Secretary of the Commission, 888 First Street, NE., Washington, DC 20426. 43. All comments will be placed in the Commission's public files and may be viewed, printed, or downloaded remotely as described in the Document Availability section below. Commenters on this proposal are not required to serve copies of their comments on other commenters. VIII. Document Availability 44. In addition to publishing the full text of this document in the **Federal Register** , the Commission provides all interested persons an opportunity to view and/or print the contents of this document via the Internet through FERC's Home Page ( *http://www.ferc.gov* ) and in FERC's Public Reference Room during normal business hours (8:30 a.m. to 5 p.m. Eastern time) at 888 First Street, NE., Room 2A, Washington, DC 20426. 45. From FERC's Home Page on the Internet, this information is available in the eLibrary. The full text of this document is available in the eLibrary both in PDF and Microsoft Word format for viewing, printing, and/or downloading. To access this document in eLibrary, type the docket number excluding the last three digits of this document in the docket number field. 42 42 NAESB's Dec. 26, 2007, submittal is also available for viewing in eLibrary. The link to this file is as follows: *http://elibrary.ferc.gov:0/idmws/doc_info.asp?document_id=13566661.* 46. User assistance is available for eLibrary and the FERC's web site during our normal business hours. For assistance contact FERC Online Support at *FERCOnlineSupport@ferc.gov* or toll-free at
(866)208-3676, or for TTY, contact
(202)502-8659. List of Subjects in 18 CFR Part 38 Conflict of interests, Electric power plants, Electric utilities, Incorporation by reference, Reporting and recordkeeping requirements. By direction of the Commission. Commissioner Wellinghoff concurring with a separate statement attached. Kimberly D. Bose, Secretary. In consideration of the foregoing, the Commission proposes to amend Chapter I, Title 18, part 38 of the *Code of Federal Regulations,* as follows: PART 38—BUSINESS PRACTICE STANDARDS AND COMMUNICATION PROTOCOLS FOR PUBLIC UTILITIES 1. The authority citation for part 38 continues to read as follows: Authority: 16 U.S.C. 791-825r, 2601-2645; 31 U.S.C. 9701; 42 U.S.C. 7101-7352. 2. In § 38.2, paragraphs (a)(1) through
(8)are revised, and paragraphs (a)(9) through
(11)are added to read as follows: § 38.2 Incorporation by reference of North American Energy Standards Board Wholesale Electric Quadrant standards.
(a)* * *
(1)Business Practices for Open Access Same-Time Information Systems (OASIS), Version 1.4 (WEQ-001, Version 001, October 31, 2007, with minor corrections applied on November 16, 2007) with the exception of Standards 001-0.1, 001-0.9 through 001-0.13, 001-1.0 through 001-1.8, and 001-9.7;
(2)Business Practices for Open Access Same-Time Information Systems (OASIS) Standards & Communication Protocols, Version 1.4 (WEQ-002, Version 001, October 31, 2007, with minor corrections applied on November 16, 2007);
(3)Open Access Same-Time Information Systems (OASIS) Data Dictionary, Version 1.4 (WEQ-003, Version 001, October 31, 2007, with minor corrections applied on November 16, 2007);
(4)Coordinate Interchange (WEQ-004, Version 001, October 31, 2007, with minor corrections applied on November 16, 2007);
(5)Area Control Error
(ACE)Equation Special Cases (WEQ-005, Version 001, October 31, 2007, with minor corrections applied on November 16, 2007);
(6)Manual Time Error Correction (WEQ-006, Version 001, October 31, 2007, with minor corrections applied on November 16, 2007);
(7)Inadvertent Interchange Payback (WEQ-007, Version 001, October 31, 2007, with minor corrections applied on November 16, 2007);
(8)Transmission Loading Relief—Eastern Interconnection (WEQ-008, Version 001, October 31, 2007, with minor corrections applied on November 16, 2007);
(9)Gas/Electric Coordination (WEQ-011, Version 001, October 31, 2007, with minor corrections applied on November 16, 2007);
(10)Public Key Infrastructure
(PKI)(WEQ-012, Version 001, October 31, 2007, with minor corrections applied on November 16, 2007);
(11)Business Practices for Open Access Same-Time Information Systems (OASIS) Implementation Guide, Version 1.4 (WEQ-013, Version 001, October 31, 2007, with minor corrections applied on November 16, 2007). Note: The following statement will not appear in the Code of Federal Regulations. DEPARTMENT OF ENERGY Federal Energy Regulatory Commission [Docket No. RM05-5-005] Standards for Business Practices and Communication Protocols for Public Utilities April 21, 2008. WELLINGHOFF, Commissioner, *concurring:* Today, the Commission issues a Notice of Proposed Rulemaking
(NOPR)proposing to amend its regulations under the Federal Power Act 43 to incorporate by reference, among other matters, the latest version of certain business practice standards concerning the Open Access Same-Time Information Systems (OASIS) adopted by the Wholesale Electric Quadrant
(WEQ)of the North American Energy Standards Board (NAESB). 44 I appreciate NAESB's leadership and the work of the industry in developing these business practice standards. 43 16 U.S.C. 791a, *et. seq.* 44 In addition, the Commission proposes in this NOPR to incorporate by reference NAESB's new business practices standards on transmission loading relief
(TLR)for the Eastern Interconnection. I note my concurrence to the separate, concurrently issued NOPR in Docket No. RM08-7-000, in which the Commission proposes to approve, among other matters, modified Reliability Standard IRO-006-4 pertaining to TLR procedures to which the NAESB business practice we address herein relates. One of the business practice standards addressed in this NOPR, WEQ-001 Version 1.4, revises NAESB's Business Practices for OASIS and, among other matters, addresses the information that is to be posted on OASIS. This information includes posting of ancillary service offerings and prices and the process for customers to procure ancillary services. I write separately to note that in Order No. 890, the Commission determined that many ancillary services may be provided by generating units as well as other non-generation resources such as demand resources where appropriate. 45 Nothing in WEQ-001 precludes such a role for demand resources, but the definition of certain ancillary services in the standard also does not specifically reflect that possible role. 45 *See* Order No. 890 at P 888 (addressing the following ancillary services: Reactive Supply and Voltage Control, Regulation and Frequency Response, Energy Imbalances, Spinning Reserves, Supplemental Reserves, and Generator Imbalances (Schedules 2, 3, 4, 5, 6, and 9, respectively, of the *pro forma* OATT)). To remove any confusion between the *pro forma* tariff that the Commission adopted in Order No. 890 and the business practice standards for offering and procuring ancillary services on OASIS, I encourage NAESB and its stakeholders to amend WEQ-001, as soon as possible, to reflect that the above-noted ancillary services may be provided by non-generation resources such as demand resources. This will facilitate implementation of this aspect of the *pro forma* OATT. For this reason, I concur with this NOPR. Jon Wellinghoff, *Commissioner.* [FR Doc. E8-9046 Filed 4-25-08; 8:45 am] BILLING CODE 6717-01-P DEPARTMENT OF ENERGY Federal Energy Regulatory Commission 18 CFR Part 40 [Docket No. RM08-7-000] Modification of Interchange and Transmission Loading Relief Reliability Standards; and Electric Reliability Organization Interpretation of Specific Requirements of Four Reliability Standards Issued April 21, 2008. AGENCY: Federal Energy Regulatory Commission, DOE. ACTION: Notice of proposed rulemaking. SUMMARY: Pursuant to section 215 of the Federal Power Act, the Federal Energy Regulatory Commission proposes to approve six modified Reliability Standards submitted to the Commission for approval by the North American Electric Reliability Corporation (NERC). Five modified Reliability Standards pertain to interchange scheduling and coordination and one pertains to transmission loading relief procedures. In addition, the Commission proposes to approve NERC's proposed interpretations of five specific requirements of Commission-approved Reliability Standards. DATES: Comments are due June 12, 2008. ADDRESSES: You may submit comments, identified by docket number by any of the following methods: • *Agency Web Site:* *http://www.ferc.gov* . Documents created electronically using word processing software should be filed in native applications or print-to-PDF format and not in a scanned format. • *Mail/Hand Delivery:* Commenters unable to file comments electronically must mail or hand deliver an original and 14 copies of their comments to: Federal Energy Regulatory Commission, Secretary of the Commission, 888 First Street, NE., Washington, DC 20426. FOR FURTHER INFORMATION CONTACT: Patrick Harwood (Technical Information), Office of Electric Reliability, Federal Energy Regulatory Commission, 888 First Street, NE., Washington, DC 20426. Christopher Daignault (Legal Information), Office of the General Counsel, Federal Energy Regulatory Commission, 888 First Street, NE., Washington, DC 20426. SUPPLEMENTARY INFORMATION: Table of Contents Paragraph numbers I. Background 2 A. EPAct 2005 and Mandatory Reliability Standards 2 B. NERC Filings 6 II. Discussion 11 A. NERC's December 19, 2007 Filing: Interpretations 12 1. BAL-001-0—Real Power Balancing Control Performance and BAL-003-0—Frequency Response and Bias 13 a. Background 13 i. Reliability Standard BAL-001-0 13 ii. Reliability Standard BAL-003-0 15 b. NERC's Proposed Interpretations 16 i. Reliability Standard BAL-001-0 17 ii. Reliability Standard BAL-003-0 21 c. Commission Proposal 23 2. BAL-005-0—Automatic Generation Control 26 a. NERC's Proposed Interpretation 26 b. Commission Proposal 28 3. VAR-002-1—Generator Operation for Maintaining Network Voltage Schedules 29 a. NERC's Proposed Interpretation 29 b. Commission Proposal 34 B. NERC's December 21, 2007 Filing: Modification of TLR Procedure 35 1. NERC's Proposed Reliability Standard 35 a. Background 36 b. NERC Filing 38 c. Commission Proposal 47 i. Requirements 48 ii. Violation Risk Factors 50 C. NERC's December 26, 2007 Filing: Modification to Five “Interchange and Scheduling” Reliability Standards 58 1. INT-001-3—Interchange Information and INT-004-2—Dynamic Interchange Transaction Modifications 59 a. Background 59 b. NERC's Proposed Modifications 61 c. Commission Proposal 63 2. INT-005-2—Interchange Authority Distributes Arranged Interchange 64 a. INT-006-2—Response to Interchange Authority, and INT-008-2—Interchange Authority Distributes Status 64 i. Background 64 ii. NERC's Proposed Modifications 68 b. Commission Proposal 74 III. Information Collection Statement 75 IV. Environmental Analysis 82 V. Regulatory Flexibility Act Analysis 83 VI. Comment Procedures 84 VII. Document Availability 88 1. Pursuant to section 215 of the Federal Power Act (FPA), 1 the Federal Energy Regulatory Commission (Commission) proposes to approve six modified Reliability Standards submitted to the Commission for approval by the North American Electric Reliability Corporation (NERC). Five modified Reliability Standards pertain to interchange scheduling and coordination, and one pertains to transmission loading relief procedures. 2 In addition, the Commission proposes to approve NERC's proposed interpretations of five specific requirements of Commission-approved Reliability Standards. 1 16 U.S.C. 824o (Supp. V 2005). 2 The Commission is not proposing any new or modified text to its regulations. Rather, as set forth in 18 CFR Part 40, a proposed Reliability Standard will not become effective until approved by the Commission, and the ERO must post on its Web site each effective Reliability Standard. I. Background A. EPAct 2005 and Mandatory Reliability Standards 2. Section 215 of the FPA requires a Commission-certified Electric Reliability Organization
(ERO)to develop mandatory and enforceable Reliability Standards, which are subject to Commission review and approval. Once approved, the Reliability Standards may be enforced by the ERO, subject to Commission oversight, or by the Commission independently. 3 3. Pursuant to section 215 of the FPA, the Commission established a process to select and certify an ERO 4 and, subsequently, certified NERC as the ERO. 5 On April 4, 2006, as modified on August 28, 2006, NERC submitted to the Commission a petition seeking approval of 107 proposed Reliability Standards. On March 16, 2007, the Commission issued a final rule, Order No. 693, approving 83 of these 107 Reliability Standards and directing other action related to these Reliability Standards. 6 In addition, pursuant to section 215(d)(5) of the FPA, the Commission directed NERC to develop modifications to 56 of the 83 approved Reliability Standards. 7 3 *See* FPA 215(e)(3), 16 U.S.C. 824o(e)(3) (Supp. V 2005). 4 *Rules Concerning Certification of the Electric Reliability Organization; and Procedures for the Establishment, Approval and Enforcement of Electric Reliability Standards* , Order No. 672, FERC Stats. & Regs. ¶ 31,204, *order on reh'g* , Order No. 672-A, FERC Stats. & Regs. ¶ 31,212 (2006). 5 *North American Electric Reliability Corp.* , 116 FERC ¶ 61,062 (ERO Certification Order), *order on reh'g & compliance* , 117 FERC ¶ 61,126 (ERO Rehearing Order) (2006), *appeal docketed sub nom. Alcoa, Inc.* v. *FERC* , No. 06-1426 (D.C. Cir. Dec. 29, 2006). 6 *Mandatory Reliability Standards for the Bulk-Power System* , Order No. 693, FERC Stats. & Regs. ¶ 31,242, *order on reh'g* , Order No. 693-A, 120 FERC ¶ 61,053 (2007). 7 16 U.S.C. 824o(d)(5) (Supp. V 2005). Section 215(d)(5) provides, “The Commission * * * may order the Electric Reliability Organization to submit to the Commission a proposed reliability standard or a modification to a reliability standard that addresses a specific matter if the Commission considers such a new or modified reliability standard appropriate to carry out this section.” 4. In April 2007, the Commission approved delegation agreements between NERC and each of the eight Regional Entities, including the Western Electricity Coordinating Council (WECC). 8 Pursuant to such agreements, the ERO delegated responsibility to the Regional Entities to carry out compliance monitoring and enforcement of the mandatory, Commission-approved Reliability Standards. In addition, the Commission approved as part of each delegation agreement a Regional Entity process for developing regional Reliability Standards. 8 *See* *North American Electric Reliability Corp.* , 119 FERC ¶ 61,060, *order on reh'g* , 120 FERC ¶ 61,260 (2007). 5. NERC's Rules of Procedure provide that a person that is “directly and materially affected” by Bulk-Power System reliability may request an interpretation of a Reliability Standard. 9 The ERO's “standards process manager” will assemble a team with relevant expertise to address the clarification and also form a ballot pool. NERC's Rules provide that, within 45 days, the team will draft an interpretation of the Reliability Standard, with subsequent balloting. If approved by ballot, the interpretation is appended to the Reliability Standard and filed with the applicable regulatory authority for regulatory approval. 9 NERC Rules of Procedure, Appendix 3A (Reliability Standards Development Procedure), at 26-27. B. NERC Filings 6. This rulemaking proceeding consolidates and addresses three NERC filings. 7. On December 19, 2007, NERC submitted for Commission approval interpretations of requirements in four Commission-approved Reliability Standards: BAL-001-0 (Real Power Balancing Control Performance), Requirement R1; BAL-003-0 (Frequency Response and Bias), Requirement R3; BAL-005-0 (Automatic Generation Control), Requirement R17; and VAR-002-1 (Generator Operation for Maintaining Network Voltage Schedules), Requirements R1 and R2. 10 10 In its filing, NERC identifies the Reliability Standards together with NERC's proposed interpretations as BAL-001-0a, BAL-003-0a, BAL-005-0a, and VAR-002-1a. 8. On December 21, 2007, NERC submitted for Commission approval modifications to Reliability Standard IRO-006-4 (Reliability Coordination—Transmission Loading Relief) that applies to balancing authorities, reliability coordinators, and transmission operators. NERC states that the modifications “extract” from the Reliability Standard the business practices and commercial requirements from the current IRO-006-3 Reliability Standard. The business practices and commercial requirements have been transferred to a North American Energy Standards Board (NAESB) business practices document. The NAESB business practices and commercial requirements have been included in Version 001 of the NAESB Wholesale Electric Quadrant
(WEQ)Standards which NAESB filed with the Commission on the same day, December 21, 2007. 11 Further, NERC states that the modified Reliability Standard includes changes directed by the Commission in Order No. 693 related to the appropriateness of using the transmission loading relief
(TLR)procedure to mitigate violations of interconnection reliability operating limits (IROLs). 12 11 NAESB December 21, 2007 Filing, Docket No. RM05-5-005. 12 An IROL is a system operating limit that, if violated, could lead to instability, uncontrolled separation, or cascading outages that adversely impact the reliability of the Bulk-Power System. 9. On December 26, 2007, NERC submitted for Commission approval modifications to five Reliability Standards from the “Interchange Scheduling” group of Reliability Standards: INT-001-3 (Interchange Information); INT-004-2 (Dynamic Interchange Transaction Modifications); INT-005-2 (Interchange Authority Distributes Arranged Interchange); INT-006-2 (Response to Interchange Authority); and INT-008-2 (Interchange Authority Distributes Status). NERC states that the modifications to INT-001-3 and INT-004-2 eliminate waivers requested in 2002 under the voluntary Reliability Standards regime for entities in the WECC region. According to NERC, modifications to INT-005-2, INT-006-2, and INT-008-2 adjust reliability assessment time frames for proposed transactions within WECC. 13 13 The proposed, modified Reliability Standard addressed in this notice of proposed rulemaking is available on the Commission's eLibrary document retrieval system in Docket No. RM08-7-000 and also on NERC's Web site, *http://www.nerc.com* . 10. Each Reliability Standard that the ERO proposes to interpret or modify in this proceeding was approved by the Commission in Order No. 693. II. Discussion 11. The Commission discusses below the ERO's proposed interpretations and proposed modifications, and the Commission's proposed disposition of each. A. NERC's December 19, 2007 Filing: Interpretations 12. As mentioned above, NERC submitted for Commission approval interpretations of four Commission-approved Reliability Standards. 1. BAL-001-0-Real Power Balancing Control Performance and BAL-003-0-Frequency Response and Bias a. Background i. Reliability Standard BAL-001-0 13. The purpose of Reliability Standard BAL-001-0 is to maintain interconnection steady-state frequency within defined limits by balancing real power demand and supply in real-time. 14 Requirement R1 of BAL-001-0 defines the limits on area control error (ACE), which essentially is the mismatch between generation and load ( *i.e.* , the mismatch between supply and demand) within the footprint of a balancing authority, measured by the difference between the balancing authority's net actual interchange and scheduled interchange with neighboring balancing authorities, after taking into account effects of deviations in interconnection frequency. 15 The ability to constantly match load and generation within a certain tolerance directly affects the electrical state and control of the Bulk-Power System. 16 Each balancing authority thus monitors the extent of its ACE in real-time and takes appropriate action also in real-time to rebalance supply and demand. 17 Requirement R1 obliges each balancing authority, on a rolling twelve-month basis, to maintain its clock-minute averages of ACE within a specific limit. 14 *See* Reliability Standard BAL-001-0. Each Reliability Standard developed by the ERO includes a “Purpose” statement. 15 Generally, a balancing authority within an interconnection has an obligation to do its part to maintain the desired 60 Hertz
(Hz)frequency. To achieve this, each balancing authority must keep its generation output (including net imports from neighboring balancing authorities) and load in balance within its footprint. A deviation from the 60 Hz baseline system frequency signals an imbalance in supply and demand. To prevent this imbalance from propagating throughout the interconnection, steps are taken to adjust regulating reserves (generation output and demand-side management) in response to deviations from the 60 Hz optimum. *See North American Electric Reliability Corp.* , 121 FERC ¶ 61,179, at P 17
(2007)(November 16, 2007 Order). 16 If generation and load is not matched within a balancing authority's area, the resulting imbalance could result in an undue burden on adjacent balancing authorities and, if additional contingencies from disturbances are experienced, may compromise the ability of the Bulk-Power System to recover from those disturbances. *See* November 16, 2007 Order, 121 FERC ¶ 61,179 at P 28. 17 *See* November 16, 2007 Order, 121 FERC ¶ 61,179 at P 20. 14. A supply/demand imbalance between the interconnection's generation output (including net imports) and load on a real-time basis will result in a deviation from the desired 60 Hz optimum operating frequency of the interconnection. All of the balancing authorities within an interconnection must work together to correct a deviation. 18 They do this by including a frequency bias component in their ACE calculation which indicates how many more or fewer megawatts a balancing authority would have interchanged with neighboring balancing authorities if the actual frequency had been exactly maintained so as to equal to the scheduled frequency. Thus, balancing authorities calculate what their total interchange would have been if the actual frequency had been exactly maintained so as to equal to the scheduled frequency. With this information, the balancing authority can increase or decrease generation within the balancing authority's area to maintain the correct scheduled interchange. The total supply and the demand within an interconnection is balanced by the collective effort of all the balancing authorities in that interconnection to maintain the correct scheduled interchange. In this manner, frequency deviations are minimized, thereby protecting reliability without causing undue burden on any balancing authorities. 18 *See* id. P 31. ii. Reliability Standard BAL-003-0 15. The purpose of Reliability Standard BAL-003-0 is to provide a consistent method for calculating the frequency bias component of ACE. To accomplish this purpose, it is necessary to rely on historic data from a balancing authority's automatic generation control. 19 Automatic generation control is the equipment that calculates ACE on an ongoing basis and serves as a “governor” that adjusts a balancing authority's generation, and demand-side resources where available, from a central location to minimize unscheduled interchange with its neighboring balancing authorities in order to balance ACE. There are several ways that automatic generation control could be set to balance the supply and demand within the balancing authority area. One method is called the “tie-line frequency bias” mode of operation. Collective operation in this mode allows balancing authorities' automatic generation control to calculate ACE and adjust the generation in the balancing authority area in a manner that maintains the interconnection frequency and does not result in an undue burden for any balancing authority. In addition, operation in this mode allows a balancing authority to continuously collect its tie-line and frequency data that must be used when the balancing authority annually reviews the frequency bias component of its ACE calculation as specified by BAL-003-0. Requirement R3 of BAL-003-0 requires the use of the tie-line frequency bias mode of operation of automatic generation control, unless such operation is adverse to system interconnection reliability. 19 Automatic generation control refers to an automatic process whereby a balancing authority's mix and output of its generation and demand-side management is varied to offset the extent of supply and demand imbalances reflected in its ACE. November 16, 2007 Order, 121 FERC ¶ 61,179 at P 19 n.14. b. NERC's Proposed Interpretations 16. NERC further states that, on June 1, 2007, WECC requested that NERC provide a formal interpretation that addresses Requirement R1 of BAL-001-0 and Requirement R3 of BAL-003-0. In particular, WECC asked whether the use of WECC's existing automatic time error correction procedure, which is currently proposed as a regional Reliability Standard, violates Requirement R1 of BAL-001-0 or Requirement R3 of BAL-003-0. i. Reliability Standard BAL-001-0 17. Requirement R1 of BAL-001-0 provides: Each Balancing Authority shall operate such that, on a rolling 12-month basis, the average of the clock-minute averages of the Balancing Authority's Area Control Error
(ACE)divided by 10B (B is the clock-minute average of the Balancing Authority Area's Frequency Bias) times the corresponding clock-minute averages of the Interconnection's Frequency Error is less than a specific limit. This limit ε <sup>1</sup> 2 is a constant derived from a targeted frequency bound (separately calculated for each Interconnection) that is reviewed and set as necessary by the NERC Operating Committee. 18. NERC's proposed interpretation of BAL-001-0 Requirement R1 reads: • The [WECC automatic time error correction or WATEC] procedural documents ask Balancing Authorities to maintain raw ACE for [control performance standard or CPS] reporting and to control via WATEC-adjusted ACE. • As long as Balancing Authorities use raw (unadjusted for WATEC) ACE for CPS reporting purposes, the use of WATEC for control is not in violation of BAL-001 Requirement 1. (NERC December 19, 2007 Filing, Ex. A-2.) 19. As context to its interpretation, NERC explains that BAL-001-0 uses a formula for the ACE calculation equal to the difference in actual and scheduled interchange, less a component based on the frequency bias to adjust for the difference in actual and scheduled frequency, less the meter error. 20 NERC also explains that the WECC automatic time error correction procedure uses the same formula for ACE as defined in BAL-001-0 except with two additional components. 21 20 *See* NERC December 19, 2007 Filing at 8-9. 21 *See id* . 20. NERC maintains that the use of the WECC automatic time error correction procedure for control does not result in a violation of BAL-001-0 Requirement 1, provided that
(1)WECC's balancing authorities use the raw and unadjusted ACE for control performance reporting purposes and
(2)the raw, unadjusted ACE complies with Requirement R1. ii. Reliability Standard BAL-003-0 21. Requirement R3 of BAL-003-0 provides: Each Balancing Authority shall operate its Automatic Generation Control
(AGC)on Tie Line Frequency Bias, unless such operation is adverse to system or Interconnection Reliability. NERC's proposed interpretation of BAL-003-0 Requirement R3 reads: • Tie-Line Frequency Bias is one of the three foundational control modes available in a Balancing Authority's energy management system. (The other two are flat-tie and flat-frequency.) Many Balancing Authorities layer other control objectives on top of their basic control mode, such as automatic inadvertent payback, [control performance standard] optimization, time control (in single [balancing authority] interconnections). 22 22 The “flat frequency” control mode would increase or decrease generation solely based on the interconnection frequency. The “flat tie” mode would increase or decrease generation within a balancing authority area depending solely on that balancing authority's total interchange. The “tie-line frequency bias” mode combines the flat frequency and flat tie modes and adjusts generation based on the balancing authority's net interchange and the interconnection frequency. • As long as Tie-Line Frequency Bias is the underlying control mode and CPS1 is measured and reported on the associated ACE equation, 23 there is no violation of BAL-003-0 Requirement 3: 23 “CPS1” refers to Requirement R1 of BAL-001-0. ACE = (NI A —NI S )—10B (F A —F S )—I ME (NERC December 19, 2007 Filing, Ex. A-3.) 22. NERC explains that there is no violation of BAL-003-0 Requirement R3, provided that a balancing authority uses the tie-line frequency bias mode as the underlying control mode and the control performance standard (CPS1), per BAL-001-0 Requirement R1, is measured and reported on the associated ACE equation. c. Commission Proposal 23. The Commission proposes to approve the ERO's formal interpretation of Requirement R1 of BAL-001-0 and Requirement R3 of BAL-003-0. 24. The ERO's interpretation is reasonable because it clarifies that raw ACE must be used in NERC compliance reporting. Reporting of raw ACE is essential because a balancing authority could exceed ACE limits in BAL-001-0 if allowed to report an adjusted ACE that adds or subtracts amounts from the equation. This interpretation upholds the reliability goal of BAL-001-0, Requirement R1 to minimize the frequency deviation of the interconnection by constantly balancing supply and demand. The interpretation also clarifies that an entity may use automatic generation control modes layered on top of the tie-line frequency bias mode as long as the raw ACE is used in NERC compliance reporting. This would permit WECC to implement more stringent time error correction procedures that rely on additional control modes layered on top of the tie-line frequency bias mode of automatic generation control, provided they do not report adjusted ACE which, if reported, could produce ambiguous data used for frequency bias calculations. The interpretation maintains the goal of BAL-003-0, Requirement R3, by providing accurate historic data for frequency bias calculations and by using ACE calculations in automatic generation control that will adjust the generation, or demand-side resources where available, in the balancing authority area in a manner that maintains the interconnection frequency and does not result in an undue burden for any balancing authority. The Commission proposes to approve the ERO's interpretation based on the understanding that a balancing authority, in operating automatic generation control, must use tie-line frequency bias as its underlying control mode unless to do so is adverse to system or interconnection reliability. 25. In Order No. 693, the Commission stated that, according to the available data, the WECC automatic time error correction procedure is more effective in minimizing time error corrections and inadvertent interchange than the Reliability Standard BAL-004-0. 24 Therefore, the ERO's interpretation provides balancing authorities using the WECC automatic time error correction procedure with necessary clarification and certainty in accordance with the continent-wide Reliability Standards BAL-001-0 and BAL-003-0. Accordingly, this interpretation appears to be just, reasonable, not unduly discriminatory or preferential, and in the public interest. 24 Order No. 693, FERC Stats. & Regs. ¶ 31,242 at P 377. 2. BAL-005-0—Automatic Generation Control a. NERC's Proposed Interpretation 26. Requirement R17 of Reliability Standard BAL-005-0 (Automatic Generation Control) is intended to annually check and calibrate the time error and frequency devices under the control of the balancing authority that feed data into automatic generation control necessary to calculate ACE. Requirement R17 mandates that the balancing authority must adhere to an annual calibration program for time error and frequency devices. The Requirement states that a balancing authority must adhere to minimum accuracies in terms of ranges specified in Hertz, volts, amps, etc., for various listed devices, such as digital frequency transducers, voltage transducers, remote terminal unit, potential transformers, and current transformers. 27. On December 21, 2006, NERC received a request to provide a formal interpretation of Requirement R17 asking whether the only devices that need to be annually calibrated under this requirement are time error and frequency devices, and whether the list of device accuracy is simply the design accuracy of the devices listed and that those devices do not need to be calibrated on an annual basis (except the digital frequency transducer which is covered as a “frequency device”). NERC provided an interpretation clarifying that the intent of BAL-005-0, Requirement R17 is to annually check and calibrate a balancing authority's time error and frequency devices located in the control room against the common reference, and this requirement does not apply to any such devices located outside of the operations control center. b. Commission Proposal 28. On July 31, 2007, the ERO received a second request for an interpretation of Requirement R17 of BAL-005-0, which asked the ERO to further clarify the ambiguity of what devices are included in the requirement. On April 15, 2008, the ERO submitted another interpretation of Requirement R17 of BAL-005-0 and sought to withdraw its request for Commission approval of the interpretation of Requirement R17 filed in this proceeding on December 19, 2007. Accordingly, the Commission does not plan to act on the initial interpretation. The Commission will act on the April 15 interpretation in a future proceeding. 3. VAR-002-1—Generator Operation for Maintaining Network Voltage Schedules a. NERC's Proposed Interpretation 29. The stated purpose of Reliability Standard VAR-002-1 is to ensure that generators provide reactive and voltage control necessary to ensure that voltage levels, reactive flows, and reactive resources are maintained within applicable facility ratings to protect equipment and the reliable operation of the interconnection. 25 Specifically, Requirement R1 of Reliability Standard VAR-002-1 provides: 25 Most bulk electric power is generated, transported, and consumed in alternating current
(AC)networks. AC systems supply (or produce) and consume (or absorb or lose) two kinds of power: real power and reactive power. Real power accomplishes useful work ( *e.g.* , runs motors and lights lamps). Reactive power supports the voltages that must be controlled for system reliability. FERC, *Principles for Efficient and Reliable Reactive Power Supply and Consumption* , Docket No. AD05-1-000, at 17 (2005), *available at http://www.ferc.gov/legal/staff-reports.asp (Reactive Power Principles)* . The Generator Operator shall operate each generator connected to the interconnected transmission system in the automatic voltage control mode (automatic voltage regulator in service and controlling voltage) unless the Generator Operator has notified the Transmission Operator. Requirement R2 of this Reliability Standard provides: Unless exempted by the Transmission Operator, each Generator Operator shall maintain the generator voltage or Reactive Power output (within applicable Facility Ratings) as directed by the Transmission Operator. 30. NERC states that it received a request to provide a formal interpretation of Requirements R1 and R2 on January 24, 2007. The request for interpretation first asked whether automatic voltage regulator
(AVR)operation in the constant power factor or constant Mvar modes complies with Requirement R1. 26 Secondly, the request asked the ERO whether Requirement R2 gives the transmission operator the option of directing the generation owner to operate the AVR in the constant power factor or constant Mvar modes rather than the constant voltage mode. 26 “Power factor” is a measure of real power in relation to reactive power. A high power factor means that relatively more useful power is being taken or produced relative to the amount of reactive power. A lower power factor means that there is relatively more reactive power taken than real power. “Mvar” is a measure of reactive power equal to one million reactive volt-amperes. * Reactive Power Principles, supra * note 16, at 7, 12, 41, 119, 120. 31. The AVR is designed to automatically adjust generator voltage and/or power-factor to ensure proper grid operational characteristics. Constant voltage mode is the normal mode of operation for AVR and maintains the output voltage at a constant level. The constant power factor mode is a setting of the AVR that causes the generator to output a set ratio of real power to reactive power, whereas the constant Mvar mode is a setting that causes the generator to maintain an output with a constant amount of reactive power. 32. NERC's formal interpretation provides that AVR operation in the constant power factor or constant Mvar modes does not comply with Requirement R1. 27 The interpretation rests on the assumption that the generator has the physical equipment that will allow such operation and that the transmission operator has not directed the generator to run in a mode other than constant voltage. The interpretation also provides that Requirement R2 does give the transmission operator the option of directing the generation operator to operate the AVR in the constant power factor or constant Mvar modes rather than the constant voltage mode. 28 27 NERC's proposed interpretation of VAR-002-1 Requirement R1 reads: 1. First, does AVR operation in the constant PF or constant Mvar modes comply with R1? Interpretation: No, only operation in constant voltage mode meets this requirement. This answer is predicated on the assumption that the generator has the physical equipment that will allow such operation and that the Transmission Operator has not directed the generator to run in a mode other than constant voltage. 2. Second, does R2 give the Transmission Operator the option of directing the Generation Owner
(sic)to operate the AVR in the constant Pf or constant Mvar modes rather than the constant voltage mode? Interpretation: Yes, if the Transmission Operator specifically directs a Generator Operator to operate the AVR in a mode other than constant voltage mode, then that directed mode of AVR operation is allowed. NERC December 19, 2007 Filing, Ex. C-2. 28 We note, as does NERC, the requesting party's apparent error when it references “Generation Owner” instead of the generator operator. 33. In its transmittal letter, NERC explains that, with respect to the interpretation of Requirement R1, Reliability Standard VAR-002-1 clearly states that the generator operator shall operate with the automatic voltage regulator in service and controlling voltage. The interpretation specifies that this can only be accomplished by using the constant voltage control mode, and using the constant power factor or constant Mvar control is not a true method to control voltage even though it may have some effect on voltage. In addition, NERC explains that Requirement R2 provides for an exemption to this baseline mode of operation to allow the transmission operator the ability to direct the generator operator to use another mode of operation. b. Commission Proposal 34. The Commission proposes to approve the ERO's interpretation of Requirement R1 and Requirement R2 of VAR-002-1. These interpretations appear to be reasonable and do not appear to change or conflict with the stated responsibilities set forth in the two requirements as approved in Order No. 693. Therefore, this interpretation appears to be just, reasonable, not unduly discriminatory or preferential, and in the public interest. B. NERC's December 21, 2007 Filing: Modification of TLR Procedure 1. NERC's Proposed Reliability Standard 35. As mentioned above, on December 21, 2007, NERC submitted for Commission approval proposed Reliability Standard IRO-006-4, to modify the current Commission-approved Reliability Standard, IRO-006-3. a. Background 36. In Order No. 693, the Commission approved the current version of this Reliability Standard, IRO-006-3. This Reliability Standard ensures that a reliability coordinator has a coordinated transmission service curtailment and reconfiguration method that can be used along with other alternatives, such as redispatch or demand-side management, to avoid transmission limit violations when the transmission system is congested. Reliability Standard IRO-006-3 establishes a detailed TLR process for use in the Eastern Interconnection to alleviate loadings on the system by curtailing or changing transactions based on their priorities and the severity of the transmission congestion. 29 29 The equivalent interconnection-wide TLR procedures for use in WECC and Electric Reliability Council of Texas (ERCOT) are known as “WSCC Unscheduled Flow Mitigation Plan” and section 7 of the “ERCOT Protocols,” respectively. 37. In addition to approving IRO-006-3, the Commission in Order No. 693 directed the ERO to modify the Reliability Standard to:
(1)Include a clear warning that the TLR procedure is an inappropriate and ineffective tool to mitigate actual IROL violations; 30 and
(2)identify in a requirement the available alternatives to mitigate an IROL violation other than use of the TLR procedure. 31 These directives reflect an observation from the U.S.-Canada Power System Outage Task Force in the August 14, 2003 Blackout Report, which identified that the TLR procedure is often too slow for use in situations where the system has already violated IROLs. 32 In setting forth these directives, the Commission stated that it did not have concerns with the use of the TLR procedure to avoid potential IROL violations. 33 30 An IROL is a system operating limit that, if violated, could lead to instability, uncontrolled separation, or cascading outages that adversely impact the reliability of the Bulk-Power System. 31 Order No. 693, FERC Stats. & Regs. ¶ 31,242 at P 964. 32 U.S.-Canada Power System Outage Task Force, *Final Report on the August 14, 2003 Blackout in the United States and Canada: Causes and Recommendations,* at 163 (April 2004) ( *Final Blackout Report* ), *available at https://reports.energy.gov/.* 33 Order No. 693, FERC Stats. & Regs. ¶ 31,242 at P 962. b. NERC Filing 38. According to NERC, the modifications embodied in proposed Reliability Standard IRO-006-4 represent the first phase of a three-phase project intended to improve the overall quality of IRO-006. In the first phase, NERC extracted the business practices and commercial requirements from the existing IRO-006-3 Reliability Standard and proposes to transfer them into the NAESB business practices. 34 NERC's filing does not seek to modify the remaining reliability requirements of IRO-006, with the exception that the Reliability Standard has been clarified to include the Commission's Order No. 693 directive that using the TLR procedure is not effective to mitigate an actual IROL violation. 34 The NAESB business practices and commercial requirements have been included in Version 001 of the NAESB Wholesale Electric Quadrant standards and filed with the Commission on December 21, 2007. The NAESB filing is the subject of a separate rulemaking in Docket No. RM05-5-005. A notice of proposed rulemaking addressing the NAESB filing is being issued concurrently with the immediate NOPR. 39. According to NERC, the second phase of the IRO-006 project will address possible changes to the regional differences associated with the congestion management process used by the PJM Interconnection, L.L.C., the Midwest Independent System Operator, Inc., and the Southwest Power Pool, Inc. In the third phase, NERC plans to completely redraft the Reliability Standard to incorporate further enhancements and changes beyond the separation of reliability and business practices. 40. In its filing, NERC explains that the filed Reliability Standard IRO-006-4 meets the guidance outlined in Order No. 672, used to determine whether a Reliability Standard is just, reasonable, not unduly discriminatory or preferential, and in the public interest. 35 In addition, IRO-006-4 includes violation risk factors and violation severity levels that were not provided with IRO-006-3. 35 Order No. 672, FERC Stats. & Regs. ¶ 31,204 at P 326. 41. NERC's proposed IRO-006-4 Reliability Standard consists of five requirements. Proposed Requirement R1 obligates a reliability coordinator experiencing a potential or actual system operating limit
(SOL)or IROL violation within its reliability coordinator area to select one or more procedures to provide transmission loading relief. The requirement also identifies the regional TLR procedures in WECC and Electric Reliability Council of Texas (ERCOT). The requirement includes a warning that the TLR procedure alone is an inappropriate and ineffective tool to mitigate an IROL violation and provides alternatives. 42. Proposed Requirement 2 mandates that the reliability coordinator only use a congestion management procedure to which the transmission operator experiencing the SOL or IROL is a party. NERC explains that Requirement R1 and Requirement R2 are assigned a violation risk factor of “lower” because they are administrative in nature and are merely intended to describe how a reliability coordinator may choose a procedure to implement TLR. 36 According to NERC, these Requirements are not intended to duplicate the requirements of other Reliability Standards that ensure the system is operated within SOL and IROL limits such as Requirements R3 and R5 of IRO-005-1, which have “high” violation risk factors. 37 NERC adds that, provided the reliability coordinator is adhering to the requirements in IRO-005-1, there is no significant risk to the reliability of the Bulk-Power System as a result of a violation of Requirement R1 of IRO-006-4. 36 Exhibit A (Reliability Standard Proposed for Approval) of NERC's December 21, 2007 filing, however, contains the violation risk factor of “medium” for these requirements, but NERC indicates elsewhere that it is “lower.” NERC December 21, 2007 Filing at 12-13. 37 *Id.* at 13. 43. Proposed Requirement R3 establishes that a reliability coordinator with a TLR obligation from an interconnection-wide procedure follow the curtailments as directed by the interconnection-wide procedure. The requirement includes that a reliability coordinator desiring to use a local procedure as a substitute for curtailments as directed by the interconnection-wide procedure shall obtain prior approval of the local procedure from the ERO. NERC states that a violation risk factor of “lower” for Requirement R3 is appropriate because it is intended that an entity could choose alternate actions for relief other than curtailments specified by this requirement to ensure reliability. 44. Proposed Requirement R4 mandates that each reliability coordinator comply with interconnection-wide procedures, once they are implemented, to curtail transactions that cross interconnection boundaries. 45. Proposed Requirement R5 directs balancing authorities and reliability coordinators to comply with applicable interchange-related Reliability Standards during the implementation of TLR procedures. NERC proposes “medium” violation risk factors for Requirement R4 and Requirement R5 explaining that, while failure to comply with these requirements could lead the system to an unbalanced scenario, such failure would not pose a “high” risk to the system. 46. Finally, NERC explains that four violation severity levels have been assigned to Requirement R1 of IRO-006-4 based on the number of violations of interconnection-wide procedure requirements, and these levels are intended to base violation severity on the degree of deviation from the requirements by the violator. NERC states that there is a single violation severity level for each of the remaining requirements ( *i.e.* , R2, R3, R4, and R5), because an entity simply either “passes” or “fails” each of these requirements. c. Commission Proposal 47. The Commission proposes to approve Reliability Standard IRO-006-4 as just, reasonable, not unduly discriminatory or preferential, and in the public interest. In addition, the Commission proposes to direct the ERO to modify certain violation risk factors that correspond to the Requirements of the Reliability Standard. i. Requirements 48. NERC's proposal implements the Commission's directives
(1)to include a clear warning that the TLR procedure is an inappropriate and ineffective tool to mitigate actual IROL violations; and
(2)to identify in a requirement the available alternatives to mitigate an IROL violation. Specifically, Requirement R1.1 of IRO-006-4 states, “The TLR procedure alone is an inappropriate and ineffective tool to mitigate an IROL violation due to the time required to implement the procedure. Other acceptable and more effective procedures to mitigate actual IROL violations include: reconfiguration, redispatch, or load shedding.” The Commission proposes to approve this standard based on the interpretation that using a TLR procedure alone to mitigate an IROL violation is a violation of the Reliability Standard. 49. Further, the proposed division between NERC and NAESB business practices seems to be reasonable and appears to pose no harm to reliability. The Commission has long supported the coordination of business practices and Reliability Standards. As early as May 2002, the Commission urged the industry expeditiously to establish the procedures for ensuring coordination between NAESB and NERC. 38 The Commission asks for comments on whether any compromise in the reliability of the Bulk-Power System may result from the removal and transfer to NAESB of the business-related issues formerly contained in Reliability Standard IRO-006. 38 *Electricity Market Design and Structure,* 99 FERC ¶ 61,171, at P 22 (2002); *see also Standards for Business Practices and Communication Protocols for Public Utilities,* Order No. 676, FERC Stats. & Regs. ¶ 31,216, at P 6 (2006). ii. Violation Risk Factors 50. Violation risk factors delineate the relative risk to the Bulk-Power System associated with the violation of each Requirement and are used by NERC and the Regional Entities to determine financial penalties for violating a Reliability Standard. NERC assigns a lower, medium, or high violation risk factor for each mandatory Reliability Standard Requirement. 39 The Commission also established guidelines for evaluating the validity of each Violation Risk Factor assignment. 40 39 The definitions of “high,” “medium,” and “lower” are provided in *North American Electric Reliability Corp.,* 119 FERC ¶ 61,145, at P 9 (Violation Risk Factor Order), *order on reh'g,* 120 FERC ¶ 61,145
(2007)(Violation Risk Factor Rehearing). 40 The guidelines are:
(1)Consistency with the conclusions of the Blackout Report;
(2)consistency within a Reliability Standard;
(3)consistency among Reliability Standards;
(4)consistency with NERC's definition of the violation risk factor level; and
(5)treatment of requirements that co-mingle more than one obligation. The Commission also explained that this list was not necessarily all-inclusive and that it retains the flexibility to consider additional guidelines in the future. A detailed explanation is provided in Violation Risk Factor Rehearing, 120 FERC ¶ 61,145 at P 8-13. 51. The Commission is concerned regarding the violation risk factors submitted with IRO-006-4. While the approved violation risk factors for IRO-006-0 Requirement R2 through Requirement R6 are all “high,” 41 NERC proposes to revise violation risk factors for similarly-worded Requirements R1 through R5 of IRO-006-4 to “lower” or “medium.” Sub-requirements R1.1 through R1.3 are explanatory text; therefore, we propose that a violation risk factor need not be assigned to them. For consistency with the Commission's five guidelines discussed above, the Commission proposes to direct the ERO to modify the violation risk factors assigned to Requirements R1 through R4 to “high.” We discuss our concerns below. 41 The violation risk factors for these requirements were submitted by NERC on February 23, 2007, and they were approved in the Violation Risk Factor Order. 52. The Commission disagrees with the ERO that Requirement R1 is administrative in nature in describing how a reliability coordinator may choose a procedure to provide transmission loading relief. Requirement R1, as well as Requirement R2 through R4, goes beyond merely providing procedural choices for transmission loading relief, as the ERO asserts. Requirements R1 through R4 require that a reliability coordinator choose and follow the appropriate procedure to provide relief. If the reliability coordinator chooses an unapproved and ineffective procedure for relief or fails to choose a procedure entirely, potential or actual IROLs will not be mitigated as intended by the reliability coordinator. Failure to implement the proper TLR procedure likely would lead to IROL violations, which could lead to cascading outages. The implementation of the TLR procedure shares a similar reliability goal as other Reliability Standard requirements that keep the transmission system within IROLs, thus presenting a similar reliability risk and violation risk factor, if violated. 53. With respect to IRO-006-4, Requirement R1, the ERO states that, provided the reliability coordinator is adhering to the requirements in IRO-005-1, there is no significant risk to the reliability of the Bulk-Power System as a result of a violation of Requirement R1 of IRO-006-4. We disagree. The violation risk factor of a requirement represents the risk a violation of that requirement presents to the reliability of the Bulk-Power System. Violation risk factors should not be assigned differently for requirements in separate Reliability Standards based on compliance with another standard. Two requirements either achieve separate reliability goals and, therefore, violation of them represents independent risks, or two requirements share the same reliability goal. As stated in Guideline 3 of the Violation Risk Factor Order, 42 the Commission expects that the assignment of violation risk factors corresponding to requirements that address similar reliability goals in different Reliability Standards would be treated comparably. 42 119 FERC ¶ 61,145 at P 25. 54. Furthermore, a “high” violation risk factor assignment for Requirements R1 through R4 is consistent with findings of the Final Blackout Report. The report highlights that, generally, “TLRs are intended as a tool to prevent the system from being operated in an unreliable state and are not applicable in real-time emergency situations.” 43 As a result, Recommendation No. 31 in the Final Blackout Report was developed to clarify that the TLR procedure should not be used in situations involving an actual violation of an operating security limit. 43 *Final Blackout Report* at 62. 55. A medium or lower violation risk factor has been approved for the Reliability Standards in the Interchange Scheduling and Coordination
(INT)family of Reliability Standards. Requirement R5 of IRO-006-4 complements the INT group of Reliability Standards and, thus, appears to be appropriately assigned a medium violation risk factor. 56. The added “Measures” and other revisions embedded in proposed Reliability Standard IRO-006-4 do not appear to substantively change the earlier, Commission-approved version ( *i.e.* , IRO-006-3). 57. In summary, proposed Reliability Standard IRO-006-4 appears to be just, reasonable, not unduly discriminatory or preferential, and in the public interest. Accordingly, the Commission proposes to approve Reliability Standard IRO-006-4 as mandatory and enforceable. In addition, the Commission proposes to direct the ERO to modify the violation risk factors, as described above. 44 44 Although “time horizons,” which relate to the immediacy of the risk posed by a violation of a requirement, are included in this Reliability Standard, we do not propose to rule on the time horizons in this rulemaking. On March 3, 2008, in Docket No. RR08-4-000, NERC submitted proposed violation severity levels corresponding to the Requirements of 83 Commission-approved Reliability Standards. The Commission will address the violation severity levels regarding IRO-006-4 in that proceeding. C. NERC's December 26, 2007 Filing: Modification to Five “Interchange and Scheduling” Reliability Standards 58. NERC submitted for Commission approval proposed modifications to five Reliability Standards from the INT group of Reliability Standards. 1. INT-001-3—Interchange Information and INT-004-2—Dynamic Interchange Transaction Modifications a. Background 59. The Interchange Scheduling and Coordination or “INT” group of Reliability Standards address interchange transactions, which occur when electricity is transmitted from a seller to a buyer across the power grid. Reliability Standard INT-001 applies to purchasing-selling entities and balancing authorities. The stated purpose of this Reliability Standard is to “ensure that Interchange Information is submitted to the NERC-identified reliability analysis service.” Reliability Standard INT-004 is intended to “ensure Dynamic Transfers are adequately tagged to be able to determine their reliability impacts.” 60. In Order No. 693, the Commission approved the currently applicable version of these Reliability Standards, INT-001-2 and INT-004-1. 45 Further, when NERC initially submitted these two Reliability Standards for Commission approval, NERC also asked the Commission to approve a “regional difference” that would exempt WECC from requirements related to tagging dynamic schedules and inadvertent payback provisions of INT-001-2 and INT-004-1. The Commission, in Order No. 693, stated that it did not have sufficient information to address the ERO's proposed regional difference and directed the ERO to submit a filing either withdrawing the regional difference or providing additional information needed for the Commission to make a determination on the matter. 46 The effect of NERC's December 26, 2007 filing is to withdraw the regional difference with respect to WECC. 45 Order No. 693, FERC Stats. & Regs. ¶ 31,242 at P 821, 843. In addition, the Commission directed that the ERO develop modifications to INT-001-2 and INT-004-1 that address the Commission's concerns. 46 *Id.* P 825. b. NERC's Proposed Modifications 61. In May 2007, WECC requested that NERC rescind the regional difference, referred to as e-tagging waivers, 47 for Reliability Standards INT-001-2 and INT-004-1. According to NERC, WECC has developed business practices for dynamic schedules and has taken the steps needed to comply with the e-tagging of inadvertent payback interchange schedules. Thus, WECC determined that it no longer needs the e-tagging waivers. 47 An E-tag represents a transaction on the North American bulk electricity market scheduled to flow within, between, or across electric utility company territories electronically. This is done so that transmission system operators can ascertain all of the transactions impacting their local system and take any corrective actions to alleviate situations that could put the power grid at risk of damage or collapse. 62. NERC processed WECC's request through NERC's Reliability Standard Development Procedure, using its urgent action process. 48 NERC states that, by rescinding the e-tagging waivers, NERC maintains uniformity and makes no structural changes to the requirements in the current Commission-approved version of the Reliability Standards. 48 NERC December 26, 2007 Filing at 5-6. c. Commission Proposal 63. NERC states that simply rescinding these waivers will not result in structural changes to the requirements in the current Commission-approved version of the Reliability Standards and will maintain uniformity. Further, we note that WECC agrees that it no longer needs to retain the waivers. 49 Accordingly, the Commission proposes to approve INT-001-3 and INT-004-2. 49 *Id.* 2. INT-005-2—Interchange Authority Distributes Arranged Interchange a. INT-006-2—Response to Interchange Authority, and INT-008-2—Interchange Authority Distributes Status i. Background 64. In Order No. 693, the Commission approved the entire group of INT Reliability Standards. 50 50 In addition, the Commission directed the ERO to develop modifications to INT-006-1. The Commission-directed modifications are not included in the immediate filing; rather, the ERO will develop such modifications pursuant to its *Reliability Standards Development Plan 2008-2010.* 65. Reliability Standard INT-005-1 applies to the interchange authority. The stated purpose of proposed Reliability Standard INT-005-1 is to “ensure that the implementation of Interchange between Source and Sink Balancing Authorities is distributed by an Interchange Authority such that Interchange information is available for reliability assessments.” 66. Reliability Standard INT-006-1 applies to balancing authorities and transmission service providers. The stated purpose of the Reliability Standard is to “ensure that each Arranged Interchange is checked for reliability before it is implemented.” 67. Reliability Standard INT-008-1 applies to the interchange authority. The stated purpose of the Reliability Standard is to “ensure that the implementation of Interchange between Source and Sink Balancing Authorities is coordinated by an Interchange Authority.” This means that it is the interchange authorities' responsibility to oversee and coordinate the interchange from one balancing authority to another. ii. NERC's Proposed Modifications 68. In its December 26, 2007 filing, NERC addresses a specific reliability need identified by WECC in its urgent action request. 69. Requirement R1.4 of INT-007-1 requires that each balancing authority and transmission service provider provide confirmation to the interchange authority that it has approved the transactions for implementation. NERC states that for WECC the timeframe allotted for this assessment is five minutes in the original version of the Commission-approved Reliability Standards. 70. NERC explains that the proposed Reliability Standards for INT-005-2, INT-006-2, and INT-008-2 would increase the timeframe for applicable WECC entities to perform the reliability assessment from five to ten minutes for next hour interchange tags submitted in the first thirty minutes of the hour before. According to NERC, this modification is needed because the majority of next-hour tags in WECC are submitted between xx:00 and xx:30. NERC explains that the existing five minute assessment window makes it nearly impossible for balancing authorities and transmission service providers to review each tag before the five minute assessment time expires. NERC maintains that, when the time expires, the tags are denied and must be resubmitted. 71. NERC states that WECC has experienced numerous instances of transactions being denied because one or more applicable reliability entities did not actively approve the tag. In NERC's view, the current structure causes frustration and inefficiencies for entities involved in this process, as requestors are required to re-create tags that are denied. Further, NERC states that there is no reliability basis for a five minute assessment period for tags submitted at least thirty minutes ahead of the ramp-in period. 72. NERC notes that, prior to January 1, 2007, when the new INT group of Reliability Standards was implemented, WECC had a ten-minute reliability assessment period for next-hour tags. NERC states that the urgent action request restores assessment times back to ten minutes. 73. Apart from the extension of the reliability assessment period from five to ten minutes for WECC entities, NERC avers that it makes no substantive changes to the requirements in the current Commission-approved version of the Reliability Standards. b. Commission Proposal 74. The Commission proposes to approve INT-005-2, INT-006-2, and INT-008-2. The only change proposed to these Reliability Standards is the reliability assessment period for WECC. 51 51 The Commission notes that NERC's compliance with Order No. 693, with respect to Reliability Standard INT-006-1, is ongoing. *See* Order No. 693, FERC Stats. & Regs. ¶ 31,242 at P 866. III. Information Collection Statement 75. The Office of Management and Budget
(OMB)regulations require that OMB approve certain reporting and recordkeeping (collections of information) imposed by an agency. 52 The information contained here is also subject to review under section 3507(d) of the Paperwork Reduction Act of 1995. 53 As stated above, the Commission previously approved, in Order No. 693, each of the Reliability Standards that are the subject of the current rulemaking. The proposed modifications to the Reliability Standards are minor and the proffered interpretations relate to existing Reliability Standards; therefore, they do not add to or increase entities' current reporting burden. Thus, the current proposal would not materially affect the burden estimates relating to the currently effective version of the Reliability Standards presented in Order No. 693. 54 52 5 CFR 1320.11. 53 44 U.S.C. 3507(d). 54 *See* Order No. 693, FERC Stats. & Regs. ¶ 31,242 at P 1905-07. 76. For example, the proposed interpretation of BAL-001-0 and BAL-003-0 does not modify or otherwise affect the collection of information already in place. With respect to BAL-001-0, the interpretation merely clarifies the rule that is already in place, that the time error correction component of the WECC automatic time error correction calculation of ACE is not to be used in NERC performance reporting. With respect to BAL-003-0, the interpretation clarifies that layering additional control modes on top of the tie-line frequency bias mode of automatic generation control is acceptable. Layering additional control modes on top of the tie-line frequency bias mode of automatic generation control does not change the information that a balancing authority reports because the same logs, data, or measurements would be maintained. 77. The proposed removal of business practice-related requirements from Reliability Standard IRO-006-4 will likely decrease, not increase, the reporting burden associated with the current, Commission-approved version of the Reliability Standard. Nor would the proposed revision to certain Reliability Standards to allow WECC an additional five minutes to perform a reliability assessment regarding interchange transactions impact the reporting burden. Further, the proposal to rescind the requested waivers from the e-tagging obligation under Reliability Standards INT-001-3 and INT-004-2 for entities in the WECC region does not change the reporting burden because NERC was never granted its requested waiver to exempt WECC from requirements related to tagging dynamic schedules and inadvertent payback. 55 In addition, WECC already has business practice standards in place that fulfill the dynamic transfer e-tagging reporting and record keeping obligations set forth in these Reliability Standards. 56 55 *See* Order No. 693, FERC Stats. & Regs. ¶ 31,242 at P 822, 825 (directing ERO either to withdraw regional difference or provide additional information). 56 *See* Business Practice Standard INT-BPS-008-1 (Dynamic Transfer E-Tagging Requirements), available at *http://www.wecc.biz.* 78. Thus, the proposed modifications to the current Reliability Standards and interpretations effected by this proposed rule will not increase the reporting burden nor impose any additional information collection requirements. 79. The Commission does not foresee any additional impact on the reporting burden for small businesses, because the proposed modifications are minor and the interpretations do not increase the existing burden. However, we will submit this proposed rule to OMB for informational purposes. *Title:* Modification of Interchange and Transmission Loading Relief Reliability Standards; and Electric Reliability Organization Interpretation of Specific Requirements of Four Reliability Standards. *Action:* Proposed Collection. *OMB Control No.:* 1902-0244. *Respondents:* Businesses or other for-profit institutions; not-for-profit institutions. *Frequency of Responses:* On Occasion. *Necessity of the Information:* This proposed rule would approve six modified Reliability Standards, five of which pertain to interchange scheduling and coordination and one that pertains to transmission loading relief procedures. In addition, this proposed rule would approve interpretations of five specific requirements of Commission-approved Reliability Standards. The proposed rule would find the Reliability Standards and interpretations just, reasonable, not unduly discriminatory or preferential, and in the public interest. *Internal Review:* The Commission has reviewed the proposed Reliability Standards and interpretations and made a determination that these requirements are necessary to implement section 215 of the FPA. These requirements conform to the Commission's plan for interchange scheduling and coordination as well as transmission loading relief procedures within the energy industry. 80. Interested persons may obtain information on the reporting requirements by contacting the following: Federal Energy Regulatory Commission, 888 First Street, NE., Washington, DC 20426 [ *Attention:* Michael Miller, Office of the Executive Director, Phone:
(202)502-8415, fax:
(202)273-0873, e-mail: *michael.miller@ferc.gov* ]. 81. For submitting comments concerning the collection(s) of information and the associated burden estimate(s), please send your comments to the contact listed above and to the Office of Information and Regulatory Affairs, Office of Information and Regulatory Affairs, Washington, DC 20503 [ *Attention:* Desk Officer for the Federal Energy Regulatory Commission, phone
(202)395-4650, fax:
(202)395-7285, e-mail: *oira_submission@omb.eop.gov* ]. IV. Environmental Analysis 82. The Commission is required to prepare an Environmental Assessment or an Environmental Impact Statement for any action that may have a significant adverse effect on the human environment. 57 The Commission has categorically excluded certain actions from this requirement as not having a significant effect on the human environment. Included in the exclusion are rules that are clarifying, corrective, or procedural or that do not substantially change the effect of the regulations being amended. 58 The actions proposed herein fall within this categorical exclusion in the Commission's regulations. 57 *Regulations Implementing the National Environmental Policy Act,* Order No. 486, FERC Stats. & Regs. ¶ 30,783 (1987). 58 18 CFR 380.4(a)(2)(ii). V. Regulatory Flexibility Act Analysis 83. The Regulatory Flexibility Act of 1980
(RFA)59 generally requires a description and analysis of final rules that will have significant economic impact on a substantial number of small entities. The RFA mandates consideration of regulatory alternatives that accomplish the stated objectives of a proposed rule and that minimize any significant economic impact on a substantial number of small entities. The Small Business Administration's Office of Size Standards develops the numerical definition of a small business. ( *See* 13 CFR 121.201.) For electric utilities, a firm is small if, including its affiliates, it is primarily engaged in the transmission, generation and/or distribution of electric energy for sale and its total electric output for the preceding twelve months did not exceed four million megawatt hours. The RFA is not implicated by this proposed rule because the minor modifications and interpretations discussed herein will not have a significant economic impact on a substantial number of small entities. 59 5 U.S.C. 601-12. VI. Comment Procedures 84. The Commission invites interested persons to submit comments on the matters and issues proposed in this notice to be adopted, including any related matters or alternative proposals that commenters may wish to discuss. Comments are due 45 days from publication in the **Federal Register** . Comments must refer to Docket No. RM08-7-000, and must include the commenter's name, the organization they represent, if applicable, and their address in their comments. 85. The Commission encourages comments to be filed electronically via the eFiling link on the Commission's Web site at *http://www.ferc.gov.* The Commission accepts most standard word processing formats. Documents created electronically using word processing software should be filed in native applications or print-to-PDF format and not in a scanned format. Commenters filing electronically do not need to make a paper filing. 86. Commenters that are not able to file comments electronically must send an original and 14 copies of their comments to: Federal Energy Regulatory Commission, Secretary of the Commission, 888 First Street, NE., Washington, DC, 20426. 87. All comments will be placed in the Commission's public files and may be viewed, printed, or downloaded remotely as described in the Document Availability section below. Commenters on this proposal are not required to serve copies of their comments on other commenters. VII. Document Availability 88. In addition to publishing the full text of this document in the **Federal Register** , the Commission provides all interested persons an opportunity to view and/or print the contents of this document via the Internet through FERC's Home Page ( *http://www.ferc.gov* ) and in FERC's Public Reference Room during normal business hours (8:30 a.m. to 5 p.m. Eastern time) at 888 First Street, NE., Room 2A, Washington DC 20426. 89. From FERC's Home Page on the Internet, this information is available on eLibrary. The full text of this document is available on eLibrary in PDF and Microsoft Word format for viewing, printing, and/or downloading. To access this document in eLibrary, type the docket number excluding the last three digits of this document in the docket number field. 90. User assistance is available for eLibrary and the FERC's website during normal business hours from FERC Online Support at
(202)502-6652 (toll free at 1-866-208-3676) or e-mail at *ferconlinesupport@ferc.gov* , or the Public Reference Room at
(202)502-8371, TTY
(202)502-8659. E-mail the Public Reference Room at *public.referenceroom@ferc.gov* . List of Subjects in 18 CFR Part 40 Electric power, Electric utilities, Reporting and recordkeeping requirements. By direction of the Commission. Commissioners Wellinghoff and Kelly concurring jointly with a separate statement. Kimberly D. Bose, Secretary. Department of Energy Federal Energy Regulatory Commission [Docket No. RM08-7-000] Modification of Interchange and Transmission Loading Relief Reliability Standards; and Electric Reliability Organization Interpretation of Specific Requirements of Four Reliability Standards Issued April 21, 2008. WELLINGHOFF and KELLY, Commissioners, *concurring* : Today, the Commission issues a Notice of Proposed Rulemaking
(NOPR)proposing to approve, among other matters, modified Reliability Standard IRO-006-4 pertaining to transmission loading relief
(TLR)procedures that can be used to prevent or manage potential or actual transmission line limit violations when the transmission system is congested. An earlier version of this Reliability Standard, IRO-006-3, was approved in Order No. 693 subject to modification. 60 This Reliability Standard establishes a detailed TLR process for use in the Eastern Interconnection to alleviate loadings on the system by curtailing or changing transmission transactions based on their priorities and the severity of the transmission congestion. However, the Commission directed the ERO 61 to modify the Reliability Standard to:
(1)Include a clear warning that the TLR procedure is an inappropriate and ineffective tool to mitigate actual IROL violations, and
(2)identify in a requirement the available alternatives to mitigate an IROL violation other than use of the TLR procedure. 62 60 *Mandatory Reliability Standards for the Bulk-Power System* , Order No. 693, FERC Stats. & Regs. ¶ 31,242, *order on reh'g* , Order No. 693-A, 120 FERC ¶ 61,053 at P 964 (2007). 61 The Commission designated the North American Electric Reliability Corp.
(NERC)as the nation's electric reliability organization
(ERO)in 2006. 62 An IROL is a system operating limit that, if violated, could lead to instability, uncontrolled separation, or cascading outages that adversely impact the reliability of the Bulk-Power System. Reliability Standard IRO-006-4 contains the required warning that the TLR procedure alone is an inappropriate and ineffective tool to mitigate an IROL violation due to the time required to implement the procedure. It furthers states that other acceptable and more effective procedures to mitigate actual IROL violations include reconfiguration, redispatch, or load shedding. Load shedding reduces customers' demand involuntarily. We write separately to note that demand-side management (DSM), or voluntary demand reduction, is not explicitly included in IRO-006-4 among the acceptable alternatives to TLR procedures. Nothing in the proposed standard precludes the use of DSM that can respond quickly to emergencies as an alternative to TLR procedures. Nor is there any indication that NERC intended this to be an exhaustive list of alternatives. We understand that DSM technologies used currently to provide operating reserve (for instance, in the operating reserve markets of ISO and RTOs) would, in fact, be deployed as quick response to IROL violations and in most cases would be deployed prior to involuntary load shedding. Indeed, voluntary demand response could be a better alternative than involuntary load shedding, which, as we indicated above, IRO-006-4 identifies as an acceptable alternative to TLR procedures. In Order No. 693, the Commission directed modifications to Reliability Standards BAL-002-0 (Disturbance Control Performance), EOP-002-2 (Capacity and Energy Emergencies), VAR-001-1 (Voltage and Reactive Control), and the sensitivity studies of the TPL (Transmission Planning) standards to explicitly provide that DSM may be used as a resource to meet the requirements of those Standards. The Commission clarified that DSM should be treated on a comparable basis and must meet similar technical requirements as other resources providing this service. 63 The Commission also addressed why explicit identification in the Reliability Standard is necessary, stating: 63 Order No. 693, FERC Stats. & Regs. ¶ 31,242 at P 335. The Commission disagrees with APPA that we should not explicitly identify any type of capacity as a resource for meeting reserve contingencies. The Commission believes that listing the types of resources that can be used to meet contingency reserves makes the Reliability Standard clearer, provides users, owners and operators of the Bulk-Power System a set of options to meet contingency reserves, and treats DSM on a comparable basis with other resources. Many commenters argue that the Commission's proposed directive that would explicitly allow DSM as a resource for contingency reserves is too prescriptive. Concerns in this area generally fall into three categories:
(1)That DSM should be treated on a comparable basis as other resources;
(2)that the Reliability Standard should be based on meeting an objective as opposed to stating how that objective is met and
(3)that DSM may not be technically capable of providing this service. With regard to the first concern, the Commission clarifies that the purpose of the proposed directive is to ensure comparable treatment of DSM with conventional generation or any other technology and to allow DSM to be considered as a resource for contingency reserves on this basis without requiring the use of any particular contingency reserve option. The proposed directive as written achieves that goal. With regard to the second concern, we believe that this Reliability Standard is objective-based and we reiterate that we are simply attempting to make it inclusive of other technologies that may be able to provide contingency reserves, and are not directing the use of any particular type of resource. By specifying DSM as a potential resource for contingency reserves, the Commission is clarifying the substance of the Reliability Standard. 64 64 *Id* at P 331-33. Thus, in the interest of clarity and comparability, we would prefer to see DSM included among the list of alternatives to TLR procedures. Therefore, we would be interested in comments regarding the inclusion of DSM that is capable of responding quickly to emergencies among the alternatives to TLR procedures for mitigating transmission line limit violations to maintain system reliability. For these reasons, we concur with this NOPR. Jon Wellinghoff, Commissioner. Suedeen G. Kelly, Commissioner. [FR Doc. E8-9013 Filed 4-25-08; 8:45 am] BILLING CODE 6717-01-P DEPARTMENT OF ENERGY Federal Energy Regulatory Commission 18 CFR Part 382 [Docket No. AD08-7-000] Annual Charges Assessments for Public Utilities April 21, 2008. AGENCY: Federal Energy Regulatory Commission, DOE. ACTION: Notice of Inquiry. SUMMARY: In this Notice of Inquiry, the Commission is seeking comments on its current methodology for the assessment of electric annual charges to public utilities, in particular, whether that methodology remains fair and equitable, and on alternative methodologies. As provided in its current regulations, the Commission recovers the costs of its electric regulatory program through filing fees and, as particularly relevant here, annual charges assessed to public utilities that provide transmission service, based on the volume of electricity transmitted. This methodology reflects that regulation of transmission providers, transmission facilities and transmission service is central to Commission regulation, and that the transmission grid is the interstate highway system for wholesale power sales. This Notice will enable the Commission to determine whether its current methodology remains fair and equitable, and to review alternative methodologies. DATES: Comments are due May 28, 2008. ADDRESSES: Interested persons may submit comments, identified by Docket No. AD08-7-000, by any of the following methods: • *eFiling:* Comments may be filed electronically via the eFiling link on the Commission's Web site at *http://www.ferc.gov* . Documents created electronically using word processing software should be filed in the native application or print-to-PDF format and not in a scanned format. This will enhance document retrieval for both the Commission and the public. The Commission accepts most standard word processing formats and commenters may attach additional files with supporting information in certain other file formats. Attachments that exist only in paper form may be scanned. Commenters filing electronically should not make a paper filing. Service of rulemaking (or Notice of Inquiry) comments is not required. • *Mail/Hand Delivery:* Commenters that are not able to file electronically must mail or hand deliver an original and 14 copies of their comments to: Federal Energy Regulatory Commission, Secretary of the Commission, 888 First Street, NE., Washington, DC 20426. FOR FURTHER INFORMATION CONTACT: For further information contact: Lawrence R. Greenfield (Legal Information), Office of the General Counsel, Federal Energy Regulatory Commission, 888 First Street, NE., Washington, DC 20426,
(202)502-6415. Richard M. Wartchow (Legal Information), Office of the General Counsel, Federal Energy Regulatory Commission, 888 First Street, NE., Washington, DC 20426,
(202)502-8744. Troy D. Cole (Technical Information), Director, Division of Financial Services, Office of the Executive Director, Federal Energy Regulatory Commission, 888 First Street, NE., Washington, DC 20426,
(202)502-6161. SUPPLEMENTARY INFORMATION: 1. In this Notice of Inquiry, the Commission is seeking comments on its current methodology for the assessment of electric annual charges to public utilities, in particular, whether that methodology remains fair and equitable, and on alternative methodologies. 1 As provided in its current regulations, the Commission recovers the costs of its electric regulatory program through filing fees and, as particularly relevant here, annual charges assessed to public utilities that provide transmission service, based on the volume of electricity transmitted. This methodology reflects that regulation of transmission providers, transmission facilities and transmission service is central to Commission regulation, and that the transmission grid is the interstate highway system for wholesale power sales. This Notice will enable the Commission to determine whether its current methodology remains fair and equitable, and to review alternative methodologies. 1 This Notice of Inquiry is limited to the assessment of annual charges to public utilities regulated under Parts II and III of the Federal Power Act (FPA). It does not, therefore, address the assessment of charges for the Commission's hydroelectric, natural gas or oil pipeline regulatory programs. It also does not address recovery of Federal power marketing agency (PMA)-related costs or electric filing fees (the latter are separately charged for, among other things, petitions for declaratory orders, Commission staff interpretations and certain qualifying facility-related filings). 2. Although the Commission has held in the past that industry concerns did not justify a change to the annual charges methodology, in response to continued expressions of concern the Commission is issuing this Notice of Inquiry to seek comment on whether the existing methodology remains an appropriate means to recover the costs of the Commission's electric regulatory program or whether there is another more appropriate alternative. The Commission seeks to ascertain whether those industry concerns, although not determinative previously, may now be more valid and, if so, to review alternative proposals for the recovery of the Commission's electric regulatory program costs. The Commission also invites interested parties to submit in this proceeding their views on other possible changes to the Commission's annual charges regulations. I. Background A. Commission Authority 3. The Commission is required by section 3401 of the Omnibus Budget Reconciliation Act of 1986 (Budget Act) 2 to “assess and collect fees and annual charges in any fiscal year in amounts equal to all of the costs incurred * * * in that fiscal year.” 3 The annual charges must be computed based on methods which the Commission determines to be “fair and equitable.” 4 The Conference Report accompanying the Budget Act provides the Commission with the following guidance as to this phrase's meaning: 2 42 U.S.C. 7178 (2000). 3 This authority is in addition to that granted to the Commission in sections 10(e) and 30(e) of the FPA. *See* 16 U.S.C. 803(e), 823a(e). 4 42 U.S.C. 7178(b). [A]nnual charges assessed during a fiscal year on any person may be reasonably based on the following factors:
(1)The type of Commission regulation which applies to such person such as a gas pipeline or electric utility regulation;
(2)the total direct and indirect costs of that type of Commission regulation incurred during such year; 5
(3)the amount of energy—electricity, natural gas, or oil—transported or sold subject to Commission regulation by such person during such year; and
(4)the total volume of all energy transported or sold subject to Commission regulation by all similarly situated persons during such year. 6 5 The Commission is required to collect not only all its direct costs but also all its indirect expenses such as hearing costs and indirect personnel costs. *See* H.R. Conf. Rep. No. 99-1012 at 238 (1986), *reprinted in* 1986 U.S.C.C.A.N. 3868, 3883 (Conference Report); *see also* S. Rep. No. 99-348 at 56, 66 and 68 (1986). 6 *See* Conference Report at 238. The Commission may assess these charges by making estimates based upon data available to it at the time of the assessment. 42 U.S.C. 7178(c). 4. The Commission's annual charges do not enable the Commission to collect amounts in excess of its expenses, but merely serve as a vehicle to reimburse the United States Treasury for the Commission's expenses. 7 7 42 U.S.C. 7178(f). Congress approves the Commission's budget through annual and supplemental appropriations. B. Current Annual Charges Billing Procedure 5. As required by the Budget Act, the Commission's regulations provide for the payment of annual charges by public utilities to fund the Commission's electric regulatory program. 8 The Commission intends that these annual charges in any fiscal year will recover the Commission's estimated electric regulatory program costs (other than the costs of regulating PMAs and the electric regulatory program costs recovered through electric filing fees) for that fiscal year. In the next fiscal year, the Commission adjusts its annual charges up or down, as appropriate, both to eliminate any over-or under-recovery of the Commission's actual costs and to eliminate any over-or under-charging of any particular person. 9 8 18 CFR Part 382 (2007); *see Revision of Annual Charges Assessed to Public Utilities* , Order No. 641, FERC Stats. & Regs. ¶ 31,109 (2000), *order on reh'g* , Order No. 641-A, 94 FERC ¶ 61,290 (2001). The Commission's regulations define its electric regulatory program as “the Commission's regulation of the electric industry under Parts II and III of the Federal Power Act; Public Utility Regulatory Policies Act; Powerplant and Industrial Fuel Use Act; Department of Energy Organization Act; Energy Security Act; Regulatory Flexibility Act; Pacific Northwest Electric Power Planning and Conservation Act; Flood Control and River and Harbor Acts; Bonneville Project Act; Federal Columbia River Transmission Act; Reclamation Project Act; Nuclear Waste Policy Act; National Environmental Policy Act; and the Public Utility Holding Company Act.” 18 CFR 382.102. 9 18 CFR 382.201; *accord Annual Charges Under the Omnibus Budget Reconciliation Act of 1986* , Order No. 507, FERC Stats. & Regs. ¶ 30,839, at 31,263-64 (1988); *Texas Utilities Electric Company* , 45 FERC ¶ 61,007, at 61,027 (1988). 6. When the Commission first developed an annual charge methodology for public utilities in response to the Budget Act, it assessed charges based on two types of wholesale electricity service: transmission and wholesale sales in interstate commerce. 10 However, in Order No. 641, the Commission determined that the sweeping changes in the industry occurring in the late 1980's and the 1990's had changed the industry landscape, which consequently changed the nature of the Commission's work. 10 *See Annual Charges Under the Omnibus Budget Reconciliation Act of 1986,* Order No. 472, FERC Stats. & Regs. ¶ 30,746 (1987), *clarified* , Order No. 472-A, FERC Stats. & Regs. ¶ 30,750, *order on reh'g* , Order No. 472-B, FERC Stats. & Regs. ¶ 30,767 (1987), *order on reh'g* , Order No. 472-C, 42 FERC ¶ 61,013 (1988). 7. In Order No. 641, the Commission noted that open access transmission, functional unbundling, and the rapid movement to market-based power sales rates brought about by Order No. 888, state retail unbundling, and Order No. 2000 encouraging the formation of regional transmission organizations
(RTOs)caused the Commission's time and effort to be increasingly devoted to assuring open and equal access to public utilities' transmission systems. Order No. 641 anticipated that wholesale power rates would be increasingly disciplined by competitive market forces and less by direct regulation, and the Commission's workload had, in fact, moved away from its traditional focus on review of bilateral power sales agreements and instead focused increasingly on transmission. In order to reflect those changes, Order No. 641 changed the Commission's annual charges methodology to recover its electric regulatory program costs by assessing charges solely on the MWh of electric energy transmitted in interstate commerce by public utilities providing transmission service, rather than on both jurisdictional power sales and transmission volumes, as in the past. 11 11 Order No. 641, FERC Stats. & Regs. ¶ 31,109 at 31,848-49; *accord Annual Charges Under the Omnibus Budget Reconciliation Act of 1986 (Phibro Inc.),* 81 FERC ¶ 61,308, at 31,843-56
(1997)( *Phibro Inc.* ). 8. As such, sections 382.201(a) and
(b)of the Commission's regulations provide that the costs of the Commission's administration of its electric regulatory program (excluding the costs of regulating the PMAs such as the Bonneville Power Administration, 12 and electric regulatory program costs recovered through electric filing fees 13 ) are assessed to public utilities that provide transmission service based on the comparative amount of transmission that they provide; 14 those that have provided more transmission service (i.e., more MWhs) are charged more, and those that have provided less transmission service (i.e., less MWhs) are charged less. 15 12 The PMAs such as the Bonneville Power Administration are the subject of a separate assessment. 18 CFR 382.201(d). 13 The Commission's case-specific filing fees are spelled out in Part 381 of the Commission's regulations. 18 CFR Part 381. 14 18 CFR 382.201(a), (b). 15 *See* Order No. 641-A, 94 FERC ¶ 61,290 at 62,038. 16 The Commission's regulations define public utility, for the purpose of assessing annual charges, as “any person who owns or operates facilities subject to the jurisdiction of the Commission under Parts II and III of the Federal Power Act, and who has rate schedule(s) on file with the Commission and who is not a `qualifying small power producer' or a ‘qualifying cogenerator,’ as those terms are defined in section 3 of the Federal Power Act, or the United States or a state, or any political subdivision of the United States or a state, or any agency, authority, or instrumentality of the United States, a state, political subdivision of the United States, or political subdivision of a state.” 18 CFR 382.102. In addition, the current electric annual charges are assessed based on transmission service, and thus exclude power marketers, which typically do not provide transmission service. 17 18 CFR 382.201; see Phibro Inc., 81 FERC ¶ 61,308 at 62,424-25. 9. In calculating annual charges, the Commission first determines the total costs of its electric regulatory program and subtracts all PMA-related costs and electric filing fee collections to determine total collectible electric regulatory program costs. It then uses the data submitted under FERC Reporting Requirement No. 582 (FERC 582) to determine the total volume of transmission and exchanges for all public utilities to be assessed. 16 The Commission divides that transaction volume into its collectible electric regulatory program costs to determine the unit charge per megawatt-hour. Finally, the Commission multiplies the transaction volume for each public utility to be assessed by the unit charge per megawatt-hour to determine the annual charges for each public utility. 17 17 18 CFR 382.201; *see Phibro Inc.,* 81 FERC ¶ 61,308 at 62,424-25. 10. In response to Order No. 641, certain public utilities and members of RTOs and independent system operators (ISO), including municipal utility and cooperative members, expressed concern that this annual charges methodology may be unfair and they alleged that the resulting annual charges fall more heavily on RTO and ISO members than on public utilities that are not RTO or ISO members. These concerns were initially raised in proceedings where RTO and ISO members objected to bills reflecting the charges determined under Order No. 641 and the underlying methodology. Although they did not seek timely rehearing of Order No. 641 itself, they sought rehearing of annual charges bills determined using the Order No. 641 methodology. 18 In a second proceeding, three RTOs and ISOs filed a petition requesting that the Commission initiate a rulemaking proceeding to revise the Order No. 641 methodology, seeking lower annual charges and questioning the assumptions that the Commission made in issuing Order No. 641. 19 18 *See Revision of Annual Charges to Public Utilities (California Independent System Operator),* 101 FERC ¶ 61,043 (California ISO Order), *order dismissing reh'g,* 101 FERC ¶ 61,326
(2002)(California ISO Rehearing Order) (denying requests for rehearing filed by California Independent System Operator, Inc., New York Independent System Operator (New York ISO), Arizona Public Service Company, American Transmission Company, LLC, and American Transmission Services, Inc.). 19 *See Midwest Independent Transmission System Operator, Inc.,* 103 FERC ¶ 61,048 (Midwest ISO Order), *order denying reh'g,* 104 FERC ¶ 61,060
(2003)(Midwest ISO Rehearing Order) (denying petition for rulemaking filed by Midwest ISO, New York ISO and PJM Interconnection, LLC), *aff'd,* 388 F.3d 903 (D.C. Cir. 2004) (Midwest ISO Court Order). 11. Those proceedings raised arguments that charges should be assessed to power sales as well as transmission, 20 challenges to the Commission's finding that its work was primarily focused on transmission regulation, 21 assertions that annual charge allocations should reflect the transmission component of bundled retail sales, 22 and claims that the Commission's annual charge assessments do not reflect the level of transmission service in various regions and unduly disadvantage RTOs. The proceedings also addressed the assertion that the Commission had erred in assessing charges to RTOs and ISOs based on services provided for non-jurisdictional members. 23 20 Midwest ISO Rehearing Order, 104 FERC ¶ 61,060 at P 7. 21 *Id.* P 9. 22 *Id.* P 7 n.13. 23 Midwest ISO Order, 103 FERC ¶ 61,048 at P 15 n.25; Midwest ISO Rehearing Order, 104 FERC ¶ 61,060 at P 7. 12. After noting that those arguments represented an untimely attempt to seek rehearing of Order No. 641, the Commission responded to the specifics of each issue. The Commission rejected the arguments that annual charges should be allocated to power sales and arguments questioning whether transmission was the Commission's primary regulatory focus by noting that, in contrast to the timeframe in which the Commission established its previous methodology, the Commission was then focused increasingly on transmission through efforts related to open access transmission service, interconnection policy, and RTO and ISO regulation. 24 The Commission also noted that then-current market regulation efforts such as reforming western markets and promoting standard market design (SMD), while nominally related to power sales, were primarily focused on transmission issues. 25 The Commission reported that its reform of western markets was concerned with transmission scheduling and constraints used to manipulate prices, and its SMD proposal incorporated a new open access transmission tariff and focused on congestion management procedures. 26 24 Midwest ISO Order, 103 FERC ¶ 61,048 at P 11-12; Midwest ISO Rehearing Order, 104 FERC ¶ 61,060 at P 10. 25 *Id.* 26 *Id.* 13. The Commission rejected the suggestion that it should impose annual charges based on the transmission component of bundled retail sales, noting that such transactions formed no part of the Commission's work load at that time. 27 The Commission also refuted the suggestion that the transaction volumes that it relied on were inaccurate and understated transmission service provided by certain utilities, by pointing out that the reported transaction volumes were subject to audit and correction and annual charge assessments would be updated to reflect any correction. 28 Finally, the Commission justified assessing annual charges on public utilities based on transmission services that they provided to non-jurisdictional entities, noting that such charges were properly recoverable in rates from the non-jurisdictional utility and should be treated like any other cost of providing service. 29 27 California ISO Order, 101 FERC ¶ 61,043 at P 15; *see also* Order No. 641-A, 94 FERC ¶ 61,290 at 62,038. 28 Midwest ISO Order, 103 FERC ¶ 61,048 at P 13. 29 *Id.* P 15 & n.25. In fact, since that order, the Commission's authority over such traditionally non-jurisdictional utilities has expanded with the passage of the Energy Policy Act of 2005 (EPAct 2005). *Compare* 16 U.S.C. 824(f) *with* 16 U.S.C. 824j-1(a)-(b), 824o(b), 824u, 824v (2000 & Supp. V 2005). 14. The Midwest ISO petitioned the United States Court of Appeals for the District of Columbia for review of the Commission's orders denying the petition for rulemaking. The court denied the petition, but noted the Commission's statement in the Midwest ISO Rehearing Order that “the issues may merit further consideration at a later time.” 30 30 Midwest ISO Court Order, 388 F.3d at 923, *citing* Midwest ISO Rehearing Order, 104 FERC ¶ 61,060 at P 16. II. Discussion 15. When the Commission issued Order No. 641, it determined that its regulatory focus was turning increasingly towards regulation of transmission service and away from a case-by-case review of wholesale power sales rates. In recognition of this focus on regulating transmission service, Order No. 641 provided for the Commission to recover the costs of its electric regulatory program (not otherwise recovered by, for example, filing fees) through annual charges assessed to public utilities that provide transmission service, based on the volume of electricity transmitted. Regulation of transmission providers, transmission facilities and transmission service remains at the heart of Commission regulation. 16. Although the state of the industry in 2002 and 2003 did not justify a change to the Commission's methodology, the Commission stated that it would reconsider its methodology when the issue merited further consideration. The Commission is now seeking through this Notice of Inquiry to determine whether subsequent developments make it appropriate to revisit Order No. 641 or otherwise suggest the need for changes to its methodology for assessing annual charges to recover its electric regulatory program costs. 17. The Commission continues to devote substantial resources to oversight of transmission service. In February 2007, for example, the Commission issued Order No. 890, amending its regulations and reforming the pro forma open access transmission tariff to ensure that transmission services are provided on a just, reasonable and not unduly discriminatory or preferential basis. 31 In addition, the Commission also continues to commit substantial resources to regulation of the development and operation of RTOs and ISOs. These transmission service providers, moreover, administer complex and comprehensive energy markets and transmission tariffs that serve broad regions—New England, New York, California, the mid-Atlantic and the Midwest, among others. These RTO/ISO markets are based on regional, security-constrained economic dispatch transmission service and locational-based marginal pricing, including transmission congestion charges. Therefore, although the Commission devotes some resources to power sales regulation through its regulation of these markets, the markets are fundamentally linked to transmission service. As a result, assessing annual charges based on transmission has been a fair and equitable means to allocate the costs of regulating these markets (with such costs, in turn, being incorporated into the RTO/ISO transmission rates). Moreover, the Commission devotes extensive resources to resolving hundreds of tariff filings by these entities and their members each year—and these filings are among the most complex that the Commission faces. 31 *Preventing Undue Discrimination and Preference in Transmission Service,* Order No. 890, FERC Stats. & Regs. ¶ 31,241, Order No. 890-A, FERC Stats. & Reg. ¶ 31,261 (2007). 18. The Commission thus continues to focus very significant resources on transmission, 32 including implementation of new authority under EPAct 2005 to, among other things, approve and enforce mandatory reliability standards for the bulk-power system, which has as its center the interstate electric transmission grid. 33 Order No. 890, for example, established comprehensive requirements for coordinated, open and transparent transmission planning to facilitate the expansion of the transmission system and to address transmission congestion, which can result in higher energy prices, and other customer concerns. 32 The current electric annual charges methodology also has the advantages of being comparatively simple and easy to administer—a not insignificant concern. It is a methodology that, as well, has been challenged and upheld by the D.C. Circuit. *See supra* notes 18, 29. 33 Pub. L. No 109-58, Title XII, Subtitle A, 119 Stat. 594
(2005)(EPAct 2005) (amending the FPA, 16 U.S.C. 824, *et seq.* ). 19. The RTOs and ISOs and their members in their earlier pleadings pointed out that all transmission service in RTOs and ISOs is regulated by this Commission and therefore annual charges are assessed on both wholesale and retail transmission service. This stands in contrast to annual charges paid by a public utility that is not an RTO or ISO member, which may provide both unbundled wholesale transmission service and bundled retail transmission service; for such public utilities, only the former transmission service is considered in allocating the Commission's electric regulatory program costs. This results in a comparatively high percentage of the Commission's annual charges being assessed to RTOs and ISOs. 20. While the nature of Commission regulation of wholesale power sales has certainly changed since adoption of Order No. 641, the Commission continues to regulate wholesale power sales. Comprehensive wholesale power sales rate review proceedings are now comparatively rare. Instead of individual rate proceedings, the Commission reviews new market-based rate power sales applications, electric quarterly reports, and triennial filings and notices of changes in status for market-based rate power sellers. In 2004, the Commission revised the market-power analysis that is used to grant market-based rate authority, and, in 2007, clarified its market-based rate policies. 34 Further, the Commission establishes market rules and mitigation rules for wholesale power sales. Finally, the Commission dedicates enforcement resources to investigating compliance with rules governing wholesale power sales. 34 *Market-Based Rates for Wholesale Sales of Electric Energy, Capacity and Ancillary Services by Public Utilities,* Order No. 697, 72 FR 39904 (Jul. 20, 2007), FERC Stats. & Regs. ¶ 31,252, *clarified,* 121 FERC ¶ 61,260 (2007), *order on rehearing,* 123 FERC 61,055 (2008). 21. These facts, in combination with new programs intended to implement new EPAct 2005 authority over certain mergers and other corporate transactions and to sanction market manipulation, warrant the Commission inquiring whether the current system remains fair and equitable, or whether the concerns previously raised by RTOs and ISOs, and their members, or other changes in the industry justify a change to the current electric annual charges methodology. 22. If such a change is justified, the Commission requests comments, as described below, on whether other annual charges assessment methodologies are more suitable than the current methodology. Such alternate methodologies could include, but are not limited to:
(i)Assessing annual charges based on jurisdictional wholesale power sales as well as transmission service, 35
(ii)adopting different annual charge calculation methodologies for different types of public utilities to account for regional differences in market structure or to account for the fact that all RTO and ISO transmission service is considered when developing annual charges but that non-RTO and ISO members' bundled retail transmission service is not accounted for in annual charges, or
(iii)determining annual charges using factors other than the volume of MWh transmitted in interstate commerce, such as peak load or transmission investment. 35 To the extent that a commenter advocates assessing annual charges based on wholesale power sales, such commenter should identify what utilities should be assessed annual charges and what transactions (and/or power sales volumes) should be used in developing such charges, as well as how the Commission would calculate such charges. For example, should the methodology reflect capacity sales, energy sales or both? Should the methodology reflect shorter-term transactions, longer-term transactions or both and should the methodology treat them similarly or should the methodology treat them differently (and, if so, how)? Given that the Commission does not separately track its resources devoted to transmission regulation versus those devoted to wholesale power sales regulation, how should the Commission allocate its costs between the two? Given that any alternative annual charges methodology adopted must be practical, i.e. must be a methodology that the Commission can administer without undue burden, such questions and others are important and necessitate answers. 23. The Commission requests that interested parties submit comments, taking into account the factors listed in the Conference Report for guidance, on the following inquiries:
(A)Does the current electric annual charges assessment methodology remain a fair and equitable method for recovering the Commission's electric regulatory program costs, and why?
(B)If the current electric annual charges assessment methodology is no longer a fair and equitable method, please identify what alternative methodology is fair and equitable, and explain why, providing, where possible, empirical evidence to support any proposed methodology.
(C)For any such alternative methodology, please identify, with specificity, what entities should be assessed electric annual charges and how such an alternative methodology would work, 36 including what data the Commission would need to allocate the charges and how the Commission would obtain the data. 36 The Commission emphasizes the importance of this third question. Parties seeking a change in methodology are cautioned to give this question careful thought and thorough analysis. Broadly phrased requests that some other entities be charged will be less persuasive than specific recommendations as to which particular entities should be charged, and how. III. Comment Procedures 24. The Commission invites interested persons to submit comments on the matters and inquiries discussed in this notice, including any related matters or alternative proposals that commenters may wish to discuss. Comments are due May 28, 2008. Comments must refer to Docket No. AD08-7-000, and must include the commenter's name, the organization it represents, if applicable, and its address in their comments. 25. The Commission encourages comments to be filed electronically via the eFiling link on the Commission's Web site at *http://www.ferc.gov* . The Commission accepts most standard word processing formats. Documents created electronically using word processing software should be filed in native applications or print-to-PDF format and not in a scanned format. Commenters filing electronically do not need to make a paper filing. 26. Commenters that are not able to file comments electronically must send an original and 14 copies of their comments to: Federal Energy Regulatory Commission, Secretary of the Commission, 888 First Street, NE., Washington, DC 20426. 27. All comments will be placed in the Commission's public files and may be viewed, printed, or downloaded remotely as described in the Document Availability section below. Commenters are not required to serve copies of their comments on other commenters. IV. Document Availability 28. In addition to publishing the full text of this document in the **Federal Register** , the Commission provides all interested persons an opportunity to view and/or print the contents of this document via the Internet through the Commission's Home Page ( *http://www.ferc.gov* ) and in the Commission's Public Reference Room during normal business hours (8:30 a.m. to 5 p.m. Eastern time) at 888 First Street, NE., Room 2A, Washington, DC 20426. 29. From the Commission's Home Page on the Internet, this information is available on eLibrary. The full text of this document is available on eLibrary in PDF and Microsoft Word format for viewing, printing, and/or downloading. To access this document in eLibrary, type the docket number excluding the last three digits of this document in the docket number field. 30. User assistance is available for eLibrary and the Commission's Web site during normal business hours from FERC Online Support at
(202)502-6652 (toll free at
(866)208-3676) or e-mail at *ferconlinesupport@ferc.gov* , or the Public Reference Room at
(202)502-8371, TTY
(202)502-8659. E-mail the Public Reference Room at *public.referenceroom@ferc.gov* . By direction of the Commission. Kimberly D. Bose, Secretary. [FR Doc. E8-9199 Filed 4-25-08; 8:45 am] BILLING CODE 6717-01-P SOCIAL SECURITY ADMINISTRATION 20 CFR Part 404 [Docket No. SSA-2007-0066] RIN 0960-AG57 Revised Medical Criteria for Evaluating Malignant Neoplastic Diseases AGENCY: Social Security Administration. ACTION: Notice of proposed rulemaking. SUMMARY: We propose to revise the criteria in parts A and B of the Listing of Impairments (the listings) that we use to evaluate claims involving malignant neoplastic diseases. We apply these criteria when you claim benefits based on disability under title II and title XVI of the Social Security Act (the Act). The proposed revisions reflect our adjudicative experience, as well as advances in medical knowledge, treatment, and methods of evaluating malignant neoplastic diseases. DATES: To be sure that your comments are considered, we must receive them by *June 27, 2008* . ADDRESSES: You may submit comments by any of the following methods. Regardless of which method you choose, to ensure that we can associate your comments with the correct regulation for consideration, state that your comments refer to Docket No. SSA-2007-0066: • Federal eRulemaking Portal at *http://www.regulations.gov* . (This is the preferred method for submitting your comments.) In the Comment or Submission section, type “SSA-2007-0066”, select “Go”, and then click “Send a Comment or Submission” under the highlighted SSA-2007-00766 text. • Telefax to
(410)966-2830. • Letter to the Commissioner of Social Security, P.O. Box 17703, Baltimore, MD 21235-7703. • Deliver your comments to the Office of Regulations, Social Security Administration, 922 Altmeyer Building, 6401 Security Boulevard, Baltimore, MD 21235-6401, between 8 a.m. and 4:30 p.m. on regular business days. Comments are posted on the Federal eRulemaking Portal, or you may inspect them on regular business days by making arrangements with the contact person shown in this preamble. FOR FURTHER INFORMATION CONTACT: Rosemarie Greenwald, Social Insurance Specialist, Social Security Administration, Office of Regulations, 960 Altmeyer Building, 6401 Security Boulevard, Baltimore, MD 21235-6401. Call 410-966-7813 for further information about these proposed rules. For information on eligibility or filing for benefits, call our national toll-free number 1-800-772-1213 or TTY 1-800-325-0778, or visit our Internet Web site, Social Security Online, at *http://www.socialsecurity.gov* . SUPPLEMENTARY INFORMATION: Electronic Version The electronic file of this document is available on the date of publication in the **Federal Register** at *http://www.gpoaccess.gov/fr/index.html* . Why are we proposing to revise the adult listings for malignant neoplastic diseases? We last published final rules revising the listings for malignant neoplastic diseases in the **Federal Register** on November 15, 2004 (69 FR 67017, corrected at 70 FR 15227). In those rules, we indicated that we intended to monitor these listings and to update the criteria for any malignant neoplastic disease contained in these listings as the need arose. We are proposing changes to the listing criteria for malignant neoplastic diseases to reflect our adjudicative experience since we last issued final rules on this body system and to reflect advances in medical knowledge, treatment, and methods of evaluating malignant neoplastic diseases. We are also proposing changes to the introductory text to these listings to provide additional information about how we evaluate malignant neoplastic diseases and to update medical terminology. Many of these proposed changes are based on the answers we provided to our adjudicators who had questions about the current rules. How do we propose to revise the introductory text to the malignant neoplastic diseases listings for adults? We propose to make the following changes to 13.00I, “What do these terms in the listings mean?” • Expand the definition of “inoperable” in current 13.00I1 by adding a reference to the term “neoadjuvant therapy” and defining it. “Neoadjuvant therapy” is antineoplastic therapy, such as chemotherapy or radiation, that you receive before surgery in order to reduce the size of your tumor. In current 13.00I1, we explain that the determination of whether a tumor is inoperable “usually occurs before attempts to shrink the tumor with chemotherapy or radiation”; that is, before the administration of neoadjuvant therapy. However, it is becoming more common in medical practice to wait until neoadjuvant therapy is completed before determining whether a tumor is inoperable. Therefore, we propose to revise current 13.00I1 to define the term “neoadjuvant therapy” and to explain that the determination of whether a tumor is inoperable “may be made before or after neoadjuvant therapy,” to be consistent with current medical practice. Lastly, we propose to make minor editorial changes to clarify our list of examples of when a tumor may be considered inoperable. • Expand the definition of “unresectable” in current 13.00I2 (proposed 13.00I6) by defining the term “adjuvant therapy” and explaining how the use of this type of therapy relates to a determination of whether a tumor is unresectable. “Adjuvant therapy” is antineoplastic therapy, such as chemotherapy or radiation, that you receive after you have surgery in order to eliminate any remaining cancer cells and lessen the chance of recurrence. • Add a definition for “metastases” (proposed 13.00I2). In the proposed definition, we explain that “metastases” means spread of tumor cells by blood, lymph, or other body fluid. We also explain that “metastases” does not include the spread of tumor cells by direct extension of the tumor to other tissue or organs. • Reorganize the section to present the terms in alphabetical order for easier reference. We propose to make the following changes to 13.00K, “How do we evaluate specific malignant neoplastic diseases?” • Revise current 13.00K1a and 13.00K1b to refer to “indolent lymphoma” instead of “low grade or indolent lymphoma” to reflect current medical terminology. • Expand current 13.00K2a to recognize that testicular biopsy is an acceptable method of documenting recurrent leukemia. • Revise current 13.00K6 to clarify that we consider a brain tumor to be malignant if it is classified as grade II or higher under the World Health Organization's (WHO's) classification of tumors of the central nervous system published in 2007. (See References at the end of this preamble.) For purposes of determining disability, we do not consider grade I tumors to be malignant because they are usually associated with long-term survival, even in the rare situation in which they progress or recur following initial antineoplastic therapy. Although we would not evaluate grade I brain tumors under the listings for malignant neoplastic diseases, we would evaluate them under listing 11.05. How do we propose to revise the criteria in the malignant neoplastic listings for adults? We propose to revise current listing 13.02C, which applied to recurrent soft tissue tumors of the head and neck, except for salivary or thyroid gland tumors. The current listing excludes local vocal cord recurrence. We propose to revise the listing to specify that it does not include “recurrence in the true vocal cord.” The proposed change more accurately reflects our intent. Accordingly, under our proposal as under our current rules, recurrence of the disease in the “false” vocal cord would meet listing 13.02C. We propose to expand the criteria in current listing 13.03B2 for melanoma with palpable nodal metastases or metastases to adjacent skin (satellite lesions) or elsewhere. A palpable lymph node is a type of “clinically apparent” lymph node. As defined by the American Joint Committee on Cancer
(AJCC)in the sixth edition of the Cancer Staging Handbook (see References at the end of this preamble), “clinically apparent” means “detected by imaging studies (excluding lymphoscintigraphy) or by clinical examination.” Current medical literature establishes that a finding of melanoma with metastases to one or more “clinically apparent” lymph nodes is equivalent in severity to palpable nodal metastases. The literature also establishes that a finding of melanoma with metastases to four or more lymph nodes that are not clinically apparent is equivalent in severity to palpable nodal metastases. Therefore, we propose to expand the current listing to include these criteria. We also propose to make a minor editorial change to clarify that “elsewhere” means “distant sites.” We propose to make the following changes to current listing 13.05A for non-Hodgkin's lymphoma: • Replace the terms “intermediate or high-grade” and “low-grade or indolent” with the terms “aggressive” and “indolent,” respectively, to reflect current medical terminology; • Clarify that mycosis fungoides is an indolent lymphoma by removing it from the heading of the listing and including it as an example in proposed listing 13.05A2; and • Add an example of an aggressive lymphoma and another example of an indolent lymphoma for clarity. Current listing 13.09B, for carcinoma of the thyroid gland with metastases beyond the regional lymph nodes, provides that we consider this disease to be of listing-level severity when it progresses despite radioactive iodine treatment. We propose to add a criterion, proposed listing 13.09C, for medullary carcinoma of the thyroid gland with metastases beyond the regional lymph nodes. Because medullary carcinoma is not treated with radioactive iodine, it cannot meet current listing 13.09B. Although we are adding this criterion for adults, we are not adding a comparable criterion for children since medullary carcinoma is extremely rare in children. Instead, we are proposing to include guidance in proposed 113.00K4, the introductory text to the childhood listings, indicating that we will use listing 13.09C in the rare case in which a child has medullary carcinoma of the thyroid gland. When we published current listing 13.10B, for breast carcinoma, the spread of breast carcinoma to the supraclavicular nodes was considered to be distant metastases. However, the medical community no longer considers this to represent distant metastases for breast carcinoma. Therefore, we propose to add a criterion to current listing 13.10B for metastases to the supraclavicular nodes to make it clear that we will continue to consider metastases to the supraclavicular nodes to be of listing-level severity. We also propose to add criteria for breast cancer with metastases to the infraclavicular nodes or to 10 or more axillary nodes. In light of the current medical literature, we believe that these findings are indicative of listing-level severity as well. We propose to remove the words “carcinoma or” from the heading of current listing 13.11, for malignant neoplastic diseases of the skeletal system, to correct an editorial error. A carcinoma is a malignant tumor that begins in the skin or in tissues that line or cover internal organs. Therefore, by definition, a carcinoma cannot originate in the skeletal system. We propose to make a minor editorial change to current listing 13.13A1 for highly malignant central nervous system neoplasms to clarify that the requirement for documented metastases applies only to medulloblastoma or other primitive neuroectodermal tumors (PNETs), and not to grades III and IV astrocytomas, glioblastoma multiforme, and ependymoblastoma. This is what we intend in the current rule, but we wanted to make the current sentence structure clearer. Therefore, we propose to reorganize the sentence for clarity. We also propose to add the word “malignant” to current listing 13.13A, for central nervous system neoplasms. This would clarify that we do not evaluate benign tumors under this listing. We propose to expand the criteria in current listing 13.14, for carcinoma of the lungs, by adding proposed listing 13.14C. The proposed listing would provide that an individual with carcinoma of the superior sulcus (including Pancoast tumors) who receives multimodal antineoplastic therapy would be disabled for at least 18 months from the date of diagnosis. This criterion recognizes the debilitating effects of, and the length of time needed to recover from, treatment for this disease. At the end of the 18-month period, we would evaluate any residual impairment(s) under the criteria for the affected body system. We propose to remove current listing 13.23E1c, for ovarian cancer with ruptured ovarian capsule, tumor on the serosal surface of the ovary, ascites with malignant cells, or positive peritoneal washings. Current medical literature indicates improved prognoses for these clinical findings. Consequently, we believe that these clinical findings do not usually represent an impairment of listing-level severity. We will continue to consider ovarian cancer to be of listing-level severity if it meets the other criteria in current listing 13.23E1; that is, there is tumor extension beyond the pelvis (current listing 13.23E1a), there are metastases to or beyond the regional lymph nodes (current listing 13.23E1b), or the disease is recurrent following initial antineoplastic therapy (current listing 13.23E1d). Because of this proposed deletion, we would redesignate current listing 13.23E1d as listing 13.23E1c. We propose to revise listing 13.24B for carcinoma of the prostate gland to clarify that “visceral metastases” means metastases to internal organs. We propose to make a minor editorial change to current listing 13.27 for malignant tumors for which the primary site of origin is unknown. The current listing provides that these tumors are of listing-level severity “except for solitary squamous cell carcinoma in the neck.” We propose to revise this language to read “except for squamous cell carcinoma confined to the neck nodes” for clarity. How do we propose to revise the introductory text to the malignant neoplastic diseases listings for children? We propose to make the following changes in 113.00 to correspond to changes we propose to make in 13.00: • Add a definition of “metastases” (proposed 113.00I1); • Reorganize section 113.00I to present the terms in alphabetical order for easier reference; • Revise the guidance on lymphoma in current 113.00K1a to refer to “aggressive” lymphoma and “indolent” lymphoma and to make minor editorial changes; • Revise current 113.00K2a to add testicular biopsy as an acceptable method of documenting recurrent leukemia; and • Revise current 113.00K4 (proposed 113.00K5) to clarify when we consider a brain tumor to be malignant. We also propose to add a new 113.00K4 to provide guidance on evaluating thyroid tumors. As we indicated above, we are not proposing to add a listing for medullary carcinoma of the thyroid gland to the childhood listings because this disease is extremely rare in children. Instead, we propose to add guidance indicating that we will evaluate this disease in children under listing 13.09C. Because of this addition, we would redesignate current 113.00K4 and current 113.00K5 as 113.00K5 and 113.00K6. How do we propose to revise the criteria in the malignant neoplastic listings for children? We propose to revise current listing 113.13, for brain tumors, to be consistent with the change we are proposing in current listing 13.13A1. What programs would these proposed regulations affect? These proposed rules would affect disability determinations and decisions that we make under titles II and XVI of the Act. In addition, to the extent that Medicare entitlement and Medicaid eligibility are based on whether you qualify for disability benefits under title II or title XVI, these proposed rules would also affect the Medicare and Medicaid programs. Who can get disability benefits? Under title II of the Act, we provide for the payment of disability benefits if you are disabled and belong to one of the following three groups: • Workers insured under the Act, • Children of insured workers, and • Widows, widowers, and surviving divorced spouses (see § 404.336) of insured workers. Under title XVI of the Act, we provide for supplemental security income
(SSI)payments on the basis of disability if you are disabled and have limited income and resources. How do we define disability? Under both the title II and title XVI programs, disability must be the result of any medically determinable physical or mental impairment or combination of impairments that is expected to result in death or which has lasted or can be expected to last for a continuous period of at least 12 months. Our definitions of disability are shown in the following table: If you file a claim under * * * And you are * * * Disability means you have a medically determinable impairment(s) as described above that results in * * * title II an adult or a child the inability to do any substantial gainful activity (SGA). title XVI an individual age 18 or older the inability to do any SGA. title XVI an individual under age 18 marked and severe functional limitations. How do we decide whether you are disabled? If you are applying for benefits under title II of the Act, or if you are an adult applying for payments under title XVI of the Act, we use a five-step “sequential evaluation process” to decide whether you are disabled. We describe this five-step process in our regulations at §§ 404.1520 and 416.920. We follow the five steps in order and stop as soon as we can make a determination or decision. The steps are: 1. Are you working, and is the work you are doing substantial gainful activity? If you are working and the work you are doing is substantial gainful activity, we will find that you are not disabled, regardless of your medical condition or your age, education, and work experience. If you are not, we will go on to step 2. 2. Do you have a “severe” impairment? If you do not have an impairment or combination of impairments that significantly limits your physical or mental ability to do basic work activities, we will find that you are not disabled. If you do, we will go on to step 3. 3. Do you have an impairment(s) that meets or medically equals the severity of an impairment in the listings? If you do, and the impairment(s) meets the duration requirement, we will find that you are disabled. If you do not, we will go on to step 4. 4. Do you have the residual functional capacity
(RFC)to do your past relevant work? If you do, we will find that you are not disabled. If you do not, we will go on to step 5. 5. Does your impairment(s) prevent you from doing any other work that exists in significant numbers in the national economy, considering your RFC, age, education, and work experience? If it does, and it meets the duration requirement, we will find that you are disabled. If it does not, we will find that you are not disabled. We use a different sequential evaluation process for children who apply for payments based on disability under SSI. If you are already receiving benefits, we also use a different sequential evaluation process when we decide whether your disability continues. See §§ 404.1594, 416.924, 416.994, and 416.994a of our regulations. However, all of these processes include steps at which we consider whether your impairment(s) meets or medically equals one of our listings. What are the listings? The listings are examples of impairments that we consider severe enough to prevent you as an adult from doing any gainful activity. If you are a child seeking SSI payments based on disability, the listings describe impairments that we consider severe enough to result in marked and severe functional limitations. Although the listings are contained only in appendix 1 to subpart P of part 404 of our regulations, we incorporate them by reference in the SSI program in § 416.925 of our regulations and apply them to claims under both title II and title XVI of the Act. How do we use the listings? The listings are in two parts. There are listings for adults (part A) and for children (part B). If you are an individual age 18 or over, we apply the listings in part A when we assess your claim, and we never use the listings in part B. If you are an individual under age 18, we first use the criteria in part B of the listings. Part B contains criteria that apply only to individuals who are under age 18. If the criteria in part B do not apply, we may use the criteria in part A when those criteria give appropriate consideration to the effects of the impairment(s) in children. (See §§ 404.1525 and 416.925.) If your impairment(s) does not meet any listing, we will also consider whether it medically equals any listing; that is, whether it is as medically severe as an impairment in the listings. (See §§ 404.1526 and 416.926.) What if you do not have an impairment(s) that meets or medically equals a listing? We use the listings only to decide that you are disabled or that you are still disabled. We will not deny your claim or decide that you no longer qualify for benefits because your impairment(s) does not meet or medically equal a listing. If you have a severe impairment(s) that does not meet or medically equal any listing, we may still find you disabled based on other rules in the “sequential evaluation process.” Likewise, we will not decide that your disability has ended only because your impairment(s) no longer meets or medically equals a listing. Also, when we conduct reviews to determine whether your disability continues, we will not find that your disability has ended because we have changed a listing. Our regulations explain that, when we change our listings, we continue to use our prior listings when we review your case, if you qualified for disability benefits or SSI payments based on our determination or decision that your impairment(s) met or medically equaled a listing. In these cases, we determine whether you have experienced medical improvement, and if so, whether the medical improvement is related to the ability to work. If your condition(s) has medically improved so that your impairment(s) no longer meets or medically equals the prior listing, we evaluate your case further to determine whether you are currently disabled. We may find that you are currently disabled, depending on the full circumstances of your case. See §§ 404.1594(c)(3)(i) and 416.994(b)(2)(iv)(A). If you are a child who is eligible for SSI payments, we follow a similar rule when we decide that you have experienced medical improvement in your condition(s). See § 416.994a(b)(2). When will we start to use these rules? We will not use these rules until we evaluate the public comments we receive on them, determine whether they should be issued as final rules, and issue final rules in the **Federal Register** . If we publish final rules, we will explain in the preamble how we will apply them, and summarize and respond to the public comments. Until the effective date of any final rules, we will continue to use our current rules. How long would these proposed rules be effective? If we publish these proposed rules as final rules, they will remain in effect for 8 years after the date they become effective, unless we extend them, or revise and issue them again. Clarity of these Proposed Rules Executive Order 12866, as amended, requires each agency to write all rules in plain language. In addition to your substantive comments on these proposed rules, we invite your comments on how to make them easier to understand. For example: • Have we organized the material to suit your needs? • Are the requirements in the rules clearly stated? • Do the rules contain technical language or jargon that is not clear? • Would a different format (grouping and order of sections, use of headings, paragraphing) make the rules easier to understand? • Would more (but shorter) sections be better? • Could we improve clarity by adding tables, lists, or diagrams? • What else could we do to make the rules easier to understand? Regulatory Procedures Executive Order 12866 We have consulted with the Office of Management and Budget
(OMB)and determined that these proposed rules meet the requirements for a significant regulatory action under Executive Order 12866, as amended. Thus, they were subject to OMB review. The Office of the Chief Actuary estimates that these proposed rules, if finalized, would reduce the program costs of the Old Age, Survivors, and Disability Insurance (OASDI) and the SSI programs, as shown in the table below: Estimated Net Reductions in OASDI Benefit Payments and Federal SSI Payments Due To the Proposed Revision of the Malignant Neoplastic Diseases Listings, Fiscal Years 2009-2018 (in millions) Fiscal year OASDI SSI 2009 $1 ( 1 ) 2010 2 ( 1 ) 2011 2 ( 1 ) 2012 3 $1 2013 4 1 2014 5 1 2015 6 1 2016 7 1 2017 8 1 2018 9 1 Totals: 2019-2013 12 2 2009-2018 47 8 1 Reduction in payments of less than $500,000. Regulatory Flexibility Act We certify that these proposed rules would not have a significant economic impact on a substantial number of small entities because they would affect only individuals. Thus, a regulatory flexibility analysis as provided in the Regulatory Flexibility Act, as amended, is not required. Paperwork Reduction Act These proposed rules will impose no additional reporting or recordkeeping requirements requiring OMB clearance. References During development of these proposed rules, we consulted the following information: Alifano, M., *et al.* , Surgical treatment of superior sulcus tumors, *Chest* , Sep;124(3), 996-1003 (2003). Archie, V.C. and Thomas, C.R. Jr., Superior sulcus tumors: A mini-review. *The Oncologist* , Sep;9(5), 550-555 (2004). Asher, A., *et al.* , *A Primer of Brain Tumors: A Patient's Reference Manual* , (American Brain Tumor Association, 8th ed. 2004). Balch, C.M., *et al.* , Final version of the American Joint Committee on Cancer Staging System for Cutaneous Melanoma, *Journal of Clinical Oncology* , Aug;19(16), 3635-3648 (2001). Bell, J., *et al.* , Randomized phase III trial of three versus six cycles of adjuvant carboplatin and paclitaxel in early stage epithelial ovarian carcinoma: A Gynecologic Oncology Group study, *Gynecologic Oncology* Sep;102(3), 432-439 (2006). Benamore, R., *et al.* , Does intensive follow-up alter outcomes in patients with advanced lung cancer?, *Journal of Thoracic Oncology* , Apr;2(4), 273-281 (2007). Cliby, W.A., *et al.* , Is it justified to classify patients to stage IIIC epithelial ovarian cancer based on nodal involvement only?, *Gynecologic Oncology* , Dec;103(3), 797-801 (2006). Colombo, N., *et al.* , Ovarian cancer, *Critical Reviews in Oncology/Hematology* , Nov;60(2), 159-179 (2006). Garcia, J.A., *et al.* , Multidisciplinary approach to superior sulcus tumors, *The Cancer Journal* , May/Jun;11(3), 189-197 (2005). Greene, F.L., *et al.* , Eds., *AJCC Cancer Staging Handbook: From the AJCC Cancer Staging Manual* , (Springer, 6th ed. 2002). Kestle, J., *et al.* , Juvenile pilocytic astrocytoma of the brainstem in children, *Journal of Neurosurgery* , Aug;101(1 Suppl.), 1-6 (2004). Kleihues, P, *et al.* , The WHO classification of tumors of the nervous system, *Journal of Neuropathology and Experimental Neurology* , Mar;61(3), 215-225 (2002). Lockwood-Rayermann, S., Survivorship issues in ovarian cancer: A review, *Oncology Nursing Forum* , May;33(3), 553-562 (2006). Louis, D.N., *et al.* , Eds., *WHO Classification of Tumours of the Central Nervous System* , (International Agency for Research on Cancer, 4th ed. 2007). Marra, A., *et al.* , Induction chemotherapy, concurrent chemoradiation and surgery for Pancoast tumour, *European Respiratory Journal* , Jan;29(1), 117-126 (2007). Morton, D.L. and Cochran, A.J., The case for lymphatic mapping and sentinel lymphadenectomy in the management of primary melanoma, *British Journal of Dermatology* , Aug;151(2), 308-319 (2004). Pectasides, P., *et al.* , Treatment issues in clear cell carcinoma of the ovary: A different entity?, *The Oncologist* , Nov;11(10), 1089-1094 (2006). Rao, G.G., *et al.* , Surgical staging of ovarian low malignant potential tumors, *The Women's Oncology Review* , Mar;5(1), 29-30 (2005). Shah, H., *et al.* , Brain: The common site of relapse in patients with Pancoast or superior sulcus tumors, *Journal of Thoracic Oncology* , Nov;1(9), 1020-1022 (2006). Shimada, M., *et al.* , Outcome of patients with early ovarian cancer undergoing three courses of adjuvant chemotherapy following complete surgical staging, *International Journal of Gynecological Cancer* , Jul/Aug;15(4), 601-605 (2006). Signorelli, M., *et al.* , Conservative management in primary genital lymphoma: The role of chemotherapy, *Gynecologic Oncology* , Feb;104(2), 416-421 (2007). Steliarova, E., *et al.* , Thyroid cancer incidence and survival among European children and adolescents (1978-1997): Report from the Automated Childhood Cancer Information System project, *European Journal of Cancer* , Sep;42(13), 2150-2169 (2006). Tanvetyanon, T., *et al.* , Neoadjuvant therapy: An emerging concept in oncology, *Southern Medical Journal* , Mar;98(3), 338-344 (2005). White, R.R., *et al.* , Long-term survival in 2,505 patients with melanoma with regional lymph node metastasis, *Annals of Surgery* , Jun;235(6), 879-887 (2002). Zhang, M., *et al.* , Prognostic factors responsible for survival in sex cord stromal tumors of the ovary—An analysis of 376 women, *Gynecologic Oncology* , Feb;104(2), 396-400 (2007). These references are included in the rulemaking record for these proposed rules and are available for inspection by interested individuals making arrangements with the contact person shown in this preamble. (Catalog of Federal Domestic Program Nos. 96.001, Social Security—Disability Insurance; 96.002, Social Security—Retirement Insurance; 96.004, Social Security—Survivors Insurance; and 96.006, Supplemental Security Income) List of Subjects in 20 CFR Part 404 Administrative practice and procedure, Blind, Disability benefits, Old Age, Survivors, and Disability Insurance, Reporting and recordkeeping requirements, Social Security. Dated: January 29, 2008. Michael J. Astrue, Commissioner of Social Security. For the reasons set out in the preamble, we propose to amend Appendix 1 to subpart P of part 404 of chapter III of title 20 of the Code of Federal Regulations as set forth below: PART 404—FEDERAL OLD-AGE, SURVIVORS AND DISABILITY INSURANCE (1950-) 1. The authority citation for subpart P of part 404 continues to read as follows: Authority: Secs. 202, 205(a), (b), and (d)-(h), 216(i), 221(a) and (i), 222(c), 223, 225, and 702(a)(5) of the Social Security Act (42 U.S.C. 402, 405(a), (b), and (d)-(h), 416(i), 421(a) and (i), 422(c), 423, 425, and 902(a)(5)); sec. 211(b), Pub. L. 104-193, 110 Stat. 2105, 2189; sec. 202, Pub. L. 108-203, 118 Stat. 509 (42 U.S.C. 902 note). 2. Appendix 1 to subpart P of Part 404 is amended as follows: a. Revise the expiration date in item 14 of the introductory text before part A of appendix 1. b. Revise paragraph I of section 13.00 of part A of appendix 1. c. Amend paragraph K of section 13.00 of part A of appendix 1 by revising 13.00K1a, 13.00K1b, the third sentence of 13.00K2a, and 13.00K6. d. Revise listing 13.02C of part A of appendix 1. e. Revise listing 13.03B2 of part A of appendix 1. f. Amend listing 13.05 of part A of appendix 1 by revising the heading and listing 13.05A. g. Amend listing 13.09 of part A of appendix 1 by adding the word “OR” and listing 13.09C. h. Revise listing 13.10B of part A of appendix 1. j. Amend listing 13.11 of part A of appendix 1 by removing the words “carcinoma or.” k. Revise listings 13.13A1 and 13.13A2 of part A of appendix 1. l. Amend listing 13.14 of part A of appendix 1 by adding the word “OR” and listing 13.14C. m. Amend listing 13.23 of part A of appendix 1 by removing current listing 13.23E1c and redesignating current listing 13.23E1d as listing13.23E1c. n. Revise listing 13.24B of part A of appendix 1. o. Revise listing 13.27 of part A of appendix 1. p. Revise paragraph I of section 113.00 of part B of appendix 1. q. Amend paragraph K of section 113.00 of part B of appendix 1 by revising 113.00K1a and the third sentence of 113.00K2a, redesignating current 113.00K4 and 113.00K5 as 113.00K5 and 113.00K6, respectively, adding new 113.00K4, and revising newly designated 113.00K5. r. Revise listing 113.13 of part B of appendix 1. The revised text is set forth as follows: APPENDIX 1 TO SUBPART P OF PART 404—LISTING OF IMPAIRMENTS 14. Malignant Neoplastic Diseases (13.00 and 113.00): (Insert date 8 years from the effective date of the final rules.) *Part A* 13.00 MALIGNANT NEOPLASTIC DISEASES I. *What do these terms in the listings mean?* 1. *Inoperable:* Surgery is thought to be of no therapeutic value or the surgery cannot be performed. Examples of when surgery cannot be performed include a tumor that is too large or that invades crucial structures, or you cannot tolerate the anesthesia or surgery due to another impairment(s). This term does not include situations in which the tumor could have been surgically removed but another method of treatment was chosen; for example, an attempt at organ preservation. The determination whether a tumor is inoperable may be made before or after the administration of neoadjuvant therapy. Neoadjuvant therapy is antineoplastic therapy, such as chemotherapy or radiation, given before surgery in order to reduce the size of the tumor. 2. *Metastases:* The spread of tumor cells by blood, lymph, or other body fluid. This term does not include the spread of tumor cells by direct extension of the tumor to other tissue or organs. 3. *Persistent:* Failure to achieve a complete remission. 4. *Progressive:* The malignancy became more extensive after treatment. 5. *Recurrent, relapse:* A malignancy that had been in complete remission or entirely removed by surgery has returned. 6. *Unresectable:* The operation was performed, but the malignant tumor was not removed. This term includes situations in which a tumor is incompletely resected or the surgical margins are positive. This term does not include situations in which a tumor is completely resected but adjuvant therapy is being administered. Adjuvant therapy is antineoplastic therapy, such as chemotherapy or radiation, given after surgery in order to eliminate any remaining cancer cells and lessen the chance of recurrence. K. *How do we evaluate specific malignant neoplastic diseases?* 1. *Lymphoma.* a. Many indolent (non-aggressive) lymphomas are controlled by well-tolerated treatment modalities, although they may produce intermittent symptoms and signs. Therefore, we may defer adjudication of these cases for an appropriate period after initiation of therapy to determine whether the therapy will achieve its intended effect. (See 13.00E3.) For indolent lymphoma, the intended effect of therapy is usually stability of the disease process. When stability has been achieved, we will assess severity on the basis of the extent of involvement of other organ systems and residuals from therapy. b. A change in therapy for indolent lymphomas is usually an indicator that the therapy is not achieving its intended effect. However, it does not indicate this if the change is based on your (or your physician's) choice rather than a failure to achieve stability. If the therapy is changed solely due to choice, the requirements of listing 13.05A2 are not met. 2. *Leukemia.* a. *Acute leukemia.* * * * Recurrent disease must be documented by peripheral blood, bone marrow, or cerebrospinal fluid examination, or by testicular biopsy. * * * 6. *Brain tumors.* We use the criteria in 13.13 to evaluate malignant brain tumors. We consider a brain tumor to be malignant if it is classified as grade II or higher under the World Health Organization's (WHO's) classification of tumors of the central nervous system ( *WHO Classification of Tumours of the Central Nervous System,* 2007). We evaluate any complications of malignant brain tumors, such as resultant neurological or psychological impairments, under the criteria for the affected body system. We evaluate benign brain tumors under 11.05. 13.01 Category of Impairments, Malignant Neoplastic Diseases 13.02 *Soft tissue tumors of the head and neck* (except salivary glands—13.08—and thyroid gland—13.09). C. Recurrent disease following initial antineoplastic therapy, except recurrence in the true vocal cord. 13.03 *Skin.* OR B. Melanoma, as described in 1 or 2. 2. With metastases as described in a, b, or c: a. Metastases to one or more clinically apparent nodes; that is, nodes that are detected by imaging studies (excluding lymphoscintigraphy) or by clinical examination. b. If the nodes are not clinically apparent, with metastases to four or more nodes. c. With metastases to adjacent skin (satellite lesions) or distant sites. 13.05 *Lymphoma* (excluding T-cell lymphoblastic lymphoma—13.06). (See 13.00K1 and 13.00K2c.) A. Non-Hodgkin's lymphoma, as described in 1 or 2: 1. Aggressive lymphoma (including diffuse large B-cell lymphoma) persistent or recurrent following initial antineoplastic therapy. 2. Indolent lymphoma (including mycosis fungoides and follicular small cleaved cell) requiring initiation of more than one antineoplastic treatment regimen within a consecutive 12-month period. Consider under a disability from at least the date of initiation of the treatment regimen that failed within 12 months. 13.09 *Thyroid gland.* OR C. Medullary carcinoma with metastases beyond the regional lymph nodes. 13.10 *Breast.* (except sarcoma—13.04). (See 13.00K4.) B. Carcinoma with metastases to the supraclavicular or infraclavicular nodes, to 10 or more axillary nodes, or with distant metastases. 13.11 *Skeletal system* —sarcoma. 13.13 *Nervous system.* (See 13.00K6.) A. Central nervous system malignant neoplasms (brain and spinal cord), as described in 1 or 2: 1. Highly malignant tumors, such as medulloblastoma or other primitive neuroectodermal tumors (PNETs) with documented metastases, grades III and IV astrocytomas, glioblastoma multiforme, ependymoblastoma, diffuse intrinsic brain stem gliomas, or primary sarcomas. 2. Progressive or recurrent following initial antineoplastic therapy. 13.14 *Lungs.* OR C. Carcinoma of the superior sulcus (including Pancoast tumors) with multimodal antineoplastic therapy. Consider under a disability until at least 18 months from the date of diagnosis. Thereafter, evaluate any residual impairment(s) under the criteria for the affected body system. 13.23 *Cancers of the female genital tract* —carcinoma or sarcoma. E. Ovaries, as described in 1 or 2: 1. All tumors except germ cell tumors, with at least one of the following: a. Tumor extension beyond the pelvis; for example, tumor implants on peritoneal, omental, or bowel surfaces. b. Metastases to or beyond the regional lymph nodes. c. Recurrent following initial antineoplastic therapy. 13.24 *Prostate gland* —carcinoma. B. With visceral metastases (metastases to internal organs). 13.27 *Primary site unknown after appropriate search for primary* —metastatic carcinoma or sarcoma, except for squamous cell carcinoma confined to the neck nodes. *Part B* 113.00 MALIGNANT NEOPLASTIC DISEASES I. *What do these terms in the listings mean?* 1. *Metastases:* The spread of tumor cells by blood, lymph, or other body fluid. This term does not include the spread of tumor cells by direct extension of the tumor to other tissue or organs. 2. *Persistent:* Failure to achieve a complete remission. 3. *Progressive:* The malignancy became more extensive after treatment. 4. *Recurrent, relapse:* A malignancy that had been in complete remission or entirely removed by surgery has returned. K. *How do we evaluate specific malignant neoplastic diseases?* 1. *Lymphoma.* a. We provide criteria for evaluating aggressive lymphomas that have not responded to antineoplastic therapy in 113.05. Indolent lymphomas are rare in children. We will evaluate indolent lymphomas in children under 13.05 in part A. 2. *Leukemia.* a. *Acute leukemia.* * * * Recurrent disease must be documented by peripheral blood, bone marrow, or cerebrospinal fluid examination, or by testicular biopsy. * * * 4. *Thyroid tumors.* We use the criteria in 113.09 to evaluate anaplastic carcinoma and carcinoma treated with radioactive iodine. Medullary carcinoma of the thyroid gland, which is not treated with radioactive iodine, is rare in children. We evaluate medullary carcinoma in children under 13.09C in part A. 5. *Brain tumors.* We use the criteria in 113.13 to evaluate malignant brain tumors. We consider a brain tumor to be malignant if it is classified as grade II or higher under the World Health Organization's classification of tumors of the central nervous system ( *WHO Classification of Tumours of the Central Nervous System,* 2007). We evaluate any complications of malignant brain tumors, such as resultant neurological or psychological impairments, under the criteria for the affected body system. We evaluate benign brain tumors under 111.05. 113.01 Category of Impairments, Malignant Neoplastic Diseases 113.13 *Brain tumors.* (See 113.00K5.) Highly malignant tumors, such as medulloblastoma or other primitive neuroectodermal tumors (PNETs) with documented metastases, grades III and IV astrocytomas, glioblastoma multiforme, ependymoblastoma, diffuse intrinsic brain stem gliomas, or primary sarcomas. [FR Doc. E8-9170 Filed 4-25-08; 8:45 am] BILLING CODE 4191-02-P DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration 21 CFR Part 872 [Docket No. FDA-2008-N-0163] (formerly Docket No. 2001N-0067) Dental Devices: Classification of Encapsulated Amalgam Alloy and Dental Mercury and Reclassification of Dental Mercury; Issuance of Special Controls for Amalgam Alloy; Reopening of Comment Period AGENCY: Food and Drug Administration, HHS. ACTION: Proposed rule; reopening of comment period. SUMMARY: The Food and Drug Administration
(FDA)is reopening for 90 days, the comment period for the proposed rule, published in the **Federal Register** of February 20, 2002 (67 FR 7620), on the classification of encapsulated amalgam alloy and dental mercury, the reclassification of dental mercury, and the issuance of special controls for amalgam alloy. In the **Federal Register** of July 17, 2002 (67 FR 46941), the initial comment period was reopened for 60 days. The agency is taking this action to provide the public with an additional opportunity to comment and to request data and information that may have become available since publication of the proposed rule. DATES: Submit written or electronic comments by July 28, 2008. ADDRESSES: You may submit comments, identified by Docket No. FDA-2008-N-0163 (formerly Docket No. 2001N-0067), by any of the following methods: *Electronic Submissions* Submit electronic comments in the following way: • Federal eRulemaking Portal: *http://www.regulations.gov* . Follow the instructions for submitting comments. *Written Submissions* Submit written submissions in the following ways: • FAX: 301-827-6870. • Mail/Hand delivery/Courier [For paper, disk, or CD-ROM submissions]: Division of Dockets Management (HFA-305), Food and Drug Administration, 5630 Fishers Lane, rm. 1061, Rockville, MD 20852. To ensure more timely processing of comments, FDA is no longer accepting comments submitted to the agency by e-mail. FDA encourages you to continue to submit electronic comments by using the Federal eRulemaking Portal, as described previously, in the ADDRESSES portion of this document under *Electronic Submissions* . *Instructions* : All submissions received must include the agency name and Docket No(s). and Regulatory Information Number
(RIN)(if a RIN number has been assigned) for this rulemaking. All comments received may be posted without change to *http://www.regulations.gov* , including any personal information provided. For additional information on submitting comments, see the “How to Submit Comments” heading of the SUPPLEMENTARY INFORMATION section of this document. *Docket* : For access to the docket to read background documents or comments received, go to *http://www.regulations.gov* and insert the docket number, found in brackets in the heading of this document, into the “Search” box and follow the prompts and/or go to the Division of Dockets Management, 5630 Fishers Lane, rm. 1061, Rockville, MD 20852. FOR FURTHER INFORMATION CONTACT: Michael E. Adjodha, Center for Devices and Radiological Health (HFZ-480), Food and Drug Administration, 9200 Corporate Blvd., Rockville, MD 20850, 240-276-3688. SUPPLEMENTARY INFORMATION: I. Background In the **Federal Register** of February 20, 2002 (67 FR 7620), FDA published a proposed rule entitled “Dental Devices: Classification of Encapsulated Amalgam Alloy and Dental Mercury and Reclassification of Dental Mercury; Issuance of Special Controls for Amalgam Alloy.” In that document, FDA proposed the following actions:
(1)Issue a separate classification regulation for encapsulated amalgam alloy and dental mercury;
(2)amend the classification for amalgam alloy by adding special controls; and
(3)reclassify dental mercury from class I (general controls) to class II. FDA proposed that all three products would have the same labeling guidance as a special control. In addition, FDA proposed that dental mercury would have a voluntary American National Standards Institute
(ANSI)standard as a special control; encapsulated amalgam alloy and dental mercury would have voluntary ANSI and International Standards Organization
(ISO)standards as special controls; and the amalgam alloy products would have a voluntary ISO standard as a special control. Since that time, a 2006 joint meeting of the Dental Products Panel and the Peripheral and Central Nervous System Drugs Advisory Committee raised the need for FDA to further consider scientific issues that are potentially relevant to this classification and we seek additional comments on the proposed classification. In an effort to provide an update on the latest scientific information concerning dental amalgam, a working group of the U.S. Department of Health and Human Services, known as the Trans-agency Working Group on the Health Effects of Dental Amalgam, commissioned a new review of the scientific literature in 2004 (the 2004 review). The 2004 review, funded by the National Institutes of Health in cooperation with FDA, the Centers for Disease Control and Prevention, and the Office of the Chief Dental Officer of the Public Health Service, was completed in 2004 by Life Sciences Research Office, Inc. (LSRO). LSRO engaged an independent panel of experts from academia with preeminent qualifications and experience in the appropriate scientific disciplines needed for the 2004 review. The 2004 review was a systematic and comprehensive evaluation of approximately 300 peer-reviewed studies of dental amalgam and mercury vapor published from 1996 through 2003, intended to determine whether these studies provided new evidence related to the health effects of dental amalgam in humans. The panel concluded that the studies contained insufficient evidence to support a correlation or causal relationship between exposure to dental amalgam and kidney or cognitive dysfunction; neurodegenerative disease (specifically Alzheimer's disease and Parkinson's disease); autoimmune disease (including multiple sclerosis); or adverse pregnancy outcomes (Refs. 1 and 2). Dental amalgam was the subject of an advisory committee meeting in 2006. As announced in the **Federal Register** of April 3, 2006 (71 FR 16582), on September 6 and 7, 2006, FDA held a joint meeting of the Dental Products Panel and the Peripheral and Central Nervous System Drugs Advisory Committee (the 2006 joint committee). The 2006 joint meeting was held to discuss and make recommendations to FDA on a draft FDA White Paper (2006 draft White Paper) (Ref. 3) regarding the potential adverse health risks associated with exposure to mercury in dental amalgam. The goal of the 2006 draft White Paper was to provide an assessment and conclusions regarding significant new information and health risks from mercury in dental amalgam and to build on previous Public Health Service literature reviews and risk assessments (1993 and 1997) and reviews by other Federal agencies since 1997. The 2006 joint committee, comprised of 24 panelists, heard presentations from the following groups:
(1)Scientists;
(2)regulatory officials from Canada and Sweden, on the scientific basis for the regulation of dental amalgam in their respective countries; and
(3)FDA, on how the United States has regulated and evaluated dental amalgam. Numerous public speakers also presented their views. The 2006 joint committee then deliberated on a series of questions FDA had posed on its draft review of the dental amalgam literature and provided recommendations to the agency related to those questions (Ref. 4). By majority vote, the committee concluded that FDA's draft White Paper had significant limitations. Among its criticisms, the 2006 joint committee identified insufficient explanation about the following:
(1)How the scientific references were chosen;
(2)failure to identify the significant gaps in the scientific knowledge, particularly with respect to exposure limits; and
(3)lack of attention to sensitive subpopulations. The majority of the 2006 joint committee voted that it could not find the conclusions of the draft White Paper to be “reasonable.” Despite the limitation on the draft White Paper, the 2006 joint committee generally agreed that there is no evidence that dental amalgams cause health problems. The 2006 joint committee also agreed that the most recent well-controlled clinical studies, including two prospective clinical studies in children (Refs. 5 and 6), showed no evidence of neurological harm from dental amalgams. In addition, a more recent article corroborated this evidence (Ref. 7). Panelists provided individual recommendations, including recommendations that FDA consider requirements related to the use of dental amalgam in pregnant women and small children, as well as patient information to ensure that consumers understand that these devices contain mercury. II. Reopening of the Comment Period FDA believes it is important for members of the public to have the opportunity to further comment on FDA's proposal. Accordingly, FDA is asking for comments concerning whether these devices should be classified into class II (special controls). We specifically request comments supported by empirical data and scientific evidence concerning this classification and these special controls. In addition, if class II (special controls) is the appropriate classification for these devices, FDA requests comment on whether the two types of special controls proposed by FDA in 2002 (materials and labeling) provide reasonable assurance of the safety and effectiveness of these devices and on whether the proposed special control guidance document should be revised in light of the recommendations and with respect to the discussions by the 2006 joint committee. • Controls on the Materials. For example, should the material controls proposed by FDA address conformance to recognized consensus standards that make recommendations for testing, compressive strength, and identifying the mercury vapor released by the device? • Labeling Controls. For example, how should labeling controls, if any, address the disclosure of composition, including mercury content, and precautions regarding use of the device in sensitive subpopulations composed of individuals who respond biologically at lower levels of exposure to mercury than the general population? If so, which subpopulations should be included (e.g., children under age 6, pregnant and lactating women, hypersensitive or immunocompromised individuals)? Should the labeling controls require more specific patient labeling (e.g., informing patients of identified sensitive subpopulations of the mercury content, the alternatives to the device and their relative costs, and health risks associated with the failure to obtain dental care)? For the agency's future analysis of benefits and costs of the regulatory options for dental amalgams, FDA also requests comments, including available data, on the following questions:
(1)How many annual procedures use mercury amalgams? What are the trends?
(2)What are the differences in cost between amalgams and alternative materials (e.g., composite, other metals, ceramics, etc.)? Are there differences in replacement lives?
(3)What are reimbursement rates for dental amalgam and the alternative materials?
(4)How would labeling describing the risks of amalgam for certain subpopulations (e.g., children under age 6, pregnant and lactating women, hypersensitive or immunocompromised individuals) affect the demand for, and use of, mercury amalgam? How would the risks included in the labeling be communicated to those subpopulations?
(5)What is the current exposure to mercury for patients? For professionals? What would be the reduction in exposure associated with the alternatives described previously in this section of this document? III. How to Submit Comments Interested persons may submit to the Division of Dockets Management (see ADDRESSES ) written or electronic comments regarding this document. Submit a single copy of electronic comments to *http://www.regulations.gov* or two paper copies of any mailed comments, except that individuals may submit one paper copy. Comments are to be identified with the docket number found in brackets in the heading of this document. Received comments may be seen in the Division of Dockets Management between 9 a.m. and 4 p.m., Monday through Friday. Please note that on January 15, 2008, the FDA Division of Dockets Management Web site transitioned to the Federal Dockets Management System (FDMS). FDMS is a Governmental-wide, electronic docket management system. Electronic comments or submissions will be accepted by FDA only through FDMS at *http://www.regulations.gov* . IV. References The following references have been placed on display in the Division of Dockets Management (see ADDRESSES ) and may be seen by interested persons between 9 a.m. and 4 p.m., Monday through Friday. 1. Review and Analysis of the Literature on the Potential Adverse Health Effects of Dental Amalgam, LSRO, July 2004. 2. Brownawell, A.M., et al., “The Potential Adverse Health Effects of Dental Amalgam,” *Toxicological Reviews* , 24(1):1-10, 2006. 3. Draft FDA Update/Review of Potential Adverse Health Risks Associated With Exposure to Mercury in Dental Amalgam, National Center for Toxicological Research, FDA, August 2006. 4. Transcripts from the Joint Meeting of Dental Products Panel and Central Nervous System Drugs Advisory Committee, September 6 and 7, 2006. 5. Bellinger, D.C., et al., “Neuropsychological and Renal Effects of Dental Amalgam in Children: A Randomized Trial,” *Journal of the American Medical Association* , 295:1775-1783, 2006. 6. DeRouen, T.A., et al., “Neurobehavioral Effects of Dental Amalgam in Children: A Randomized Clinical Trial,” *Journal of the American Medical Association* , 295:1784-1792, 2006. 7. Dunn, Julie E., “Scalp hair and urine mercury content of children in the Northeast United States: The New England Children's Amalgam Trial,” *Environmental Research* , Vol. 107, Issue 1, pages 79 to 88, May 2008. Dated: April 22, 2008. Randall W. Lutter, Deputy Commissioner for Policy. [FR Doc. 08-1187 Filed 4-23-08; 10:15 am]
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79 references not yet in our index
- 7 CFR 301
- 7 CFR 301.89-1
- 10 CFR 51
- 68 Stat. 948
- 106 Stat. 2951
- 88 Stat. 1242
- 112 Stat. 2750
- 83 Stat. 853
- Pub. L. 95-604
- 92 Stat. 3033
- Pub. L. 101-575
- 104 Stat. 2835
- Pub. L. 97-425
- 96 Stat. 2232
- Pub. L. 100-203
- 101 Stat. 1330
- 73 Stat. 688
- 92 Stat. 3036
- 96 Stat. 2228
- 96 Stat. 2216
- 14 CFR 39
- 1 CFR 51
- 21 CFR 312
- 21 CFR 54
- 21 CFR 56
- 44 USC 3501-3520
- 5 USC 601-612
- Pub. L. 104-4
- Pub. L. 108-429
- 118 Stat. 2434
- 27 CFR 4
- 27 CFR 24
- 27 CFR 27
- 40 CFR 52
- 40 CFR 97.102
- 40 CFR 52.541
- 40 CFR 52.745
- 40 CFR 52.746
- 40 CFR 52.1140
- 40 CFR 52.1285
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