Unknown. Final rule

3,017 words·~14 min read·/register/2005/10/20/05-20974

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--- schema: federal-register doc_type: fedreg source_file: FR-2005-10-20.xml --- 70 202 Thursday, October 20, 2005 Contents Agricultural Agricultural Marketing Service PROPOSED RULES Fresh fruit and vegetable terminal market inspection services; fee revisions, 61068 05-20961 Agriculture Agriculture Department See Agricultural Marketing Service See Animal and Plant Health Inspection Service See Commodity Credit Corporation See Forest Service Animal Animal and Plant Health Inspection Service RULES Interstate transportation of animals and animal products (quarantine):

Tuberculosis in cattle, bison, and captive cervids— Affected herd; definition, 61025-61026 05-20974 Centers Centers for Disease Control and Prevention RULES Possession, use and transfer of select agents and toxins: 1918 pandemic influenza virus; reconstructed replication competent forms, 61047-61049 05-20946 Centers Centers for Medicare & Medicaid Services See Inspector General Office, Health and Human Services Department Coast Guard Coast Guard RULES Regattas and marine parades:

Hampton Roads Sailboard Classic, 61032-61034 05-21017 Spa Creek, Annapolis, MD, 61034-61037 05-21018 NOTICES Environmental statements; notice of intent: Neptune LNG, L.L.C. liquified natural gas; deepwater port license application, 61151-61152 05-21007 Meetings: National Boating Safety Advisory Council, 61152-61153 05-21008 Commerce Commerce Department See International Trade Administration See National Oceanic and Atmospheric Administration CITA Committee for the Implementation of Textile Agreements NOTICES Textile and apparel categories:

Chinese imports; safeguard actions, 61121 05-21107 Commodity Commodity Credit Corporation NOTICES Domestic Sugar Program: 2004-crop cane sugar and sugar beet marketing allotments and allocations, 61113-61115 05-20960 Comptroller Comptroller of the Currency PROPOSED RULES Risk-based capital: Capital framework; guidelines and modifications, 61068-61078 05-20858 Customs Customs and Border Protection Bureau RULES Merchandise, special classes: Nicaragua; archaeological material from pre-Hispanic cultures; import restrictions, 61031-61032 05-21049 Defense Defense Nuclear Facilities Safety Board NOTICES Meetings;

Sunshine Act, 61121-61122 05-21052 Drug Drug Enforcement Administration NOTICES *Applications, hearings, determinations, etc.:* Boehringer Ingelheim Chemicals, Inc., 61160 05-20950 Johnson Matthey, Inc., 61160 05-20949 Rhodes Technologies, 61160 05-20948 Education Education Department RULES Postsecondary education: Student assistance general provisions; Federal Perkins Loan, Federal Direct Loan, Federal Family Education Loan Programs; waivers and modifications, 61037 05-21012 NOTICES Grants and cooperative agreements; availability, etc.:

Special education and rehabilitative services— Steppingstones of Technology Innovation for Children with Disabilities; correction, 61122 05-21019 Energy Energy Department See Federal Energy Regulatory Commission NOTICES Meetings: Environmental Management Site-Specific Advisory Board— Rocky Flats, CO, 61123 05-20989 EPA Environmental Protection Agency RULES Air programs; approval and promulgation; State plans for designated facilities and pollutants: Massachusetts, 61044-61046 05-20985 Reports and guidance documents; availability, etc.:

Clean Water State Revolving Fund program recipients; State fees, 61039-61044 05-21014 PROPOSED RULES Air pollution; standards of performance for new stationary sources: Electric generating units; emissions test, 61081-61103 05-20983 Air programs; approval and promulgation; State plans for designated facilities and pollutants: Massachusetts, 61106-61107 05-20984 Air quality implementation plans; approval and promulgation; various States: West Virginia, 61104-61106 05-20986 Radiation protection programs:

Energy Department; Waste Isolation Pilot Plant compliance recertification application, 61107-61111 05-20987 NOTICES Agency information collection activities; proposals, submissions, and approvals, 61124-61128 05-20980 05-20981 Air programs: State implementation plans; adequacy status for transportation conformity purposes— Indiana, 05-20978 61128-61129 05-20979 Committees; establishment, renewal, termination, etc.: Pesticide Program Dialogue Committee, 61129-61130 05-21076 Confidential business information and data transfer, 61130-61131 05-21075 Executive Executive Office of the President See Presidential Documents Export Export-Import Bank NOTICES Meetings:

Sub-Saharan Africa Advisory Committee, 61131 05-20951 FAA Federal Aviation Administration RULES Class E airspace, 61026-61027 05-21002 Standard instrument approach procedures, 61027-61030 05-20849 PROPOSED RULES Airworthiness directives: Airbus, 61078-61080 05-20965 NOTICES Agency information collection activities; proposals, submissions, and approvals, 61163-61164 05-21001 05-21003 Environmental statements; record of decision: Washington Dulles International Airport, VA, 61164-61165 05-21032 FCC Federal Communications Commission RULES Common carrier services:

Wireless telecommunications services— Wireless radio services; licensing provisions, 61049-61062 05-20927 NOTICES Agency information collection activities; proposals, submissions, and approvals, 61131 05-21000 FDIC Federal Deposit Insurance Corporation PROPOSED RULES Risk-based capital: Capital framework; guidelines and modifications, 61068-61078 05-20858 Federal Energy Federal Energy Regulatory Commission NOTICES Environmental statements; availability, etc.: New York State Electric & Gas Corp., 61123-61124 E5-5788 *Applications, hearings, determinations, etc.:* Crete Energy Venture, LLC, 61123 E5-5789 Federal Motor Federal Motor Carrier Safety Administration PROPOSED RULES Motor carrier safety standards:

Motor carrier qualifications to self-insure operations and fees to support approval and compliance process; withdrawn, 61111-61112 05-20718 NOTICES Motor carrier safety standards: Driver qualifications— Thomas E. Adams, et al., 61165-61166 05-21006 Federal Reserve Federal Reserve System PROPOSED RULES Risk-based capital: Capital framework; guidelines and modifications, 61068-61078 05-20858 NOTICES Banks and bank holding companies: Formations, acquisitions, and mergers, 61132 E5-5782 Fish Fish and Wildlife Service NOTICES Environmental statements; notice of intent:

Incidental take permits— Kern County waste facilities, CA; habitat conservation plan, 61153-61155 05-20967 Food Food and Drug Administration NOTICES Meetings: Anesthetic and Life Support Drugs Advisory Committee, 61132-61133 05-20970 Reports and guidance documents; availability, etc.: International Conference on Harmonisation— Human pharmaceuticals; delayed ventricular repolarization; potential evaluation, 61133-61134 05-20959 International Conference on Harmonization— QT/QTc interval prolongation and Proarrhythmic potential for non-antiarrhythmic drugs;

E14 clinical evaluation, 61134-61135 05-20971 Source plasma containing disease-associated and other immunoglobulin antibodies collection program; implementation, 61135-61136 05-20958 Forest Forest Service NOTICES Environmental statements; notice of intent: San Juan National Forest, CO, 61115-61116 05-20964 Meetings: Resource Advisory Committees— Lake County, 61116 05-20988 GSA General Services Administration RULES Federal travel: Transportation expenses; government-furnished automobiles, 61046-61047 05-20216 Health Health and Human Services Department See Centers for Disease Control and Prevention See Food and Drug Administration See Inspector General Office, Health and Human Services Department See National Institutes of Health NOTICES Meetings:

Vital and Health Statistics National Committee, 61132 05-20991 Homeland Homeland Security Department See Coast Guard See Customs and Border Protection Bureau Housing Housing and Urban Development Department PROPOSED RULES Manufactured Housing Dispute Resolution Program, 61178-61191 05-20953 Inspector Inspector General Office, Health and Human Services Department NOTICES Program exclusions; list, 61136-61142 05-20963 Interior Interior Department See Fish and Wildlife Service See Land Management Bureau See Surface Mining Reclamation and Enforcement Office IRS Internal Revenue Service NOTICES Agency information collection activities; proposals, submissions, and approvals, 61171 E5-5784 Meetings:

Taxpayer Advocacy Panels, 61171-61172 E5-5783 International International Trade Administration NOTICES Antidumping: Cut-to-length carbon-quality steel plate products from— Italy, 61116-61117 E5-5793 Freshwater crawfish tail meat from— China, 61117 E5-5790 Pasta from— Italy, 61118 E5-5794 Polyethylene terephthalate film from— Korea, 61118-61119 E5-5792 Stainless steel butt-weld pipe fittings from— Various countries, 61119-61120 E5-5791 International International Trade Commission NOTICES Import investigations:

Heavy forged hand tools from— China, 61156 05-20975 Paper clips from— China, 61157 05-20977 Personal computers, server computers, and components, 61157-61159 05-20976 Justice Justice Department See Drug Enforcement Administration NOTICES Privacy Act; systems of records, 05-20997 61159 05-20998 Land Land Management Bureau NOTICES Meetings: Steens Mountain Advisory Council, 61155-61156 05-20995 Maritime Maritime Administration NOTICES Agency information collection activities; proposals, submissions, and approvals, 61167 05-20952 Environmental statements; notice of intent:

Neptune LNG, L.L.C. liquified natural gas; deepwater port license application, 61151-61152 05-21007 NIH National Institutes of Health NOTICES Inventions, Government-owned; availability for licensing, 61142-61144 05-21010 Meetings: National Heart, Lung, and Blood Institute, 05-21020 05-21022 61144 05-21024 National Institute of Diabetes and Digestive and Kidney Diseases, 61144-61145 05-21021 National Institute of Neurological Disorders and Stroke, 61145 05-21023 Vital and Health Statistics National Committee, 61145-61146 05-20990 Organization, functions, and authority delegations:

National Cancer Institute, 61146-61150 05-21009 NOAA National Oceanic and Atmospheric Administration RULES Fishery conservation and management: Alaska; fisheries of Exclusive Economic Zone— Pollock, 61067 05-20994 West Coast States and Western Pacific fisheries— Pacific Coast groundfish; correction, 61063-61066 05-21088 NOTICES Grants and cooperative agreements; availability, etc.: Ballast Water Technology Demonstration Program, 61120-61121 05-21027 Pipeline Pipeline and Hazardous Materials Safety Administration NOTICES Hazardous materials:

Applications; exemptions, renewals, etc., 61167-61169 05-21004 05-21005 Postal Postal Service RULES Domestic Mail Manual: Bundled flat-size and irregular parcel mail; address visibility, 61037-61039 05-20924 Presidential Presidential Documents ADMINISTRATIVE ORDERS Colombia; continuation of national emergency with respect to narcotics traffickers (Notice of October 19, 2005), 61207-61209 05-21210 SEC Securities and Exchange Commission RULES Fair fund and disgorgement plans; administration efficiency, 61030-61031 05-20973 NOTICES Self-regulatory organizations; proposed rule changes:

American Stock Exchange, LLC, 61160-61162 E5-5785 Chicago Stock Exchange, Inc., 61162-61163 E5-5786 National Association of Securities Dealers, Inc., 61163 E5-5787 Surface Surface Mining Reclamation and Enforcement Office RULES Non-Federal and non-Indian lands; permanent regulatory programs: State program amendment process, 61194-61206 05-21025 Surface Surface Transportation Board NOTICES Rail carriers: Control exemptions— Consolidated Rail Corp., 61169-61170 05-20911 Saginaw Bay Southern Railway Co., 61170 05-20968 Textile Textile Agreements Implementation Committee See Committee for the Implementation of Textile Agreements Thrift Thrift Supervision Office PROPOSED RULES Risk-based capital:

Capital framework; guidelines and modifications, 61068-61078 05-20858 Transportation Transportation Department See Federal Aviation Administration See Federal Motor Carrier Safety Administration See Maritime Administration See Pipeline and Hazardous Materials Safety Administration See Surface Transportation Board Treasury Treasury Department See Comptroller of the Currency See Internal Revenue Service See Thrift Supervision Office RULES Merchandise, special classes: Nicaragua; archaeological material from pre-Hispanic cultures; import restrictions, 61031-61032 05-21049 NOTICES Agency information collection activities; proposals, submissions, and approvals, 05-20955 61170-61171 05-20956 Veterans Veterans Affairs Department NOTICES Agency information collection activities; proposals, submissions, and approvals, E5-5778 61172-61174 E5-5779 E5-5780 E5-5781 Meetings:

Clinical Science Research and Development Service Cooperative Studies Scientific Merit Review Board, 61174 05-21015 Joint Biomedical Laboratory Research and Development and Clinical Science Research and Development Services Scientific Merit Review Board, 61174-61175 05-20947 Separate Parts In This Issue Part II Housing and Urban Development Department, 61178-61191 05-20953 Part III Interior Department, Surface Mining Reclamation and Enforcement Office, 61194-61206 05-21025 Part IV Executive Office of the President, Presidential Documents, 61207-61209 05-21210 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. 70 202 Thursday, October 20, 2005 Rules and Regulations DEPARTMENT OF AGRICULTURE Animal and Plant Health Inspection Service 9 CFR Part 77 [Docket No. 02-111-2] Tuberculosis; Amend the Definition of Affected Herd AGENCY: Animal and Plant Health Inspection Service, USDA.

ACTION: Final rule. SUMMARY: We are amending the regulations by removing the two different definitions of *affected herd* and replacing them with a single, updated definition. This action is necessary to provide more clarity in the regulations and because the current definitions are out-of-date and inconsistent. EFFECTIVE DATE: November 21, 2005. FOR FURTHER INFORMATION CONTACT: Dr. M.J. Gilsdorf, Director, Ruminant Health Programs, National Center for Animal Health Programs, VS, APHIS, 4700 River Road Unit 43, Riverdale, MD 20737-1231;

(301)734-6954. SUPPLEMENTARY INFORMATION: Background The regulations in 9 CFR part 77, “Tuberculosis” (referred to below as the regulations), and the “Uniform Methods and Rules—Bovine Tuberculosis Eradication” (UMR), January 22, 1999, edition, which is incorporated by reference into the regulations, restrict the interstate movement of cattle, bison, and captive cervids to prevent the spread of bovine tuberculosis. Subpart A of part 77 (§§ 77.1-77.4) contains general provisions of the tuberculosis regulations such as definitions; subpart B (§§ 77.5-77.19) contains specific provisions regarding cattle and bison; and subpart C (§§ 77.20-77.41) contains specific provisions regarding captive cervids. There have been two definitions of *affected herd* in part 77. In § 77.5, *affected herd* has been defined as “a herd in which tuberculosis has been disclosed in any cattle or bison by an official tuberculin test or by post mortem examination.” In § 77.20, *affected herd* has been defined as “a herd of captive cervids that contains or that has contained one or more captive cervids infected with *Mycobacterium bovis* (determined by bacterial isolation of *M. bovis* ) and that has not tested negative to the three whole herd tests as prescribed in § 77.39(d) of this part.” On July 2, 2004, we published in the **Federal Register** (69 FR 40329-40330, Docket No. 02-111-1) a proposal to amend the regulations by removing the two inconsistent definitions of *affected herd* from §§ 77.5 and 77.20 and replacing them with a new definition of the term that would apply to cattle, bison, and captive cervids. Our proposed new definition read as follows: “A herd of livestock in which there is strong and substantial evidence that *Mycobacterium bovis* exists. This evidence should include, but is not limited to, any of the following: Epidemiologic evidence, histopathology, polymerase chain reaction

(PCR)assay, bacterial isolation or detection, testing data, or association with known sources of infection.” We solicited comments concerning our proposal for 60 days ending August 31, 2004. We received three comments by that date. They were from a State government official and two private citizens. The comments are discussed below. One commenter stated that the “strong and substantial evidence” standard in the proposed definition was too high and that potentially infected animals could remain unidentified as a result. We disagree and believe that the new definition will actually increase the likelihood that the disease will be detected. For example, under the new definition, cervid herds can be classified as affected without first having a diagnosis of tuberculosis confirmed through a culture—a procedure that can be difficult and usually requires at least 8 to 12 weeks to complete. With respect to cattle, the new definition provides that a herd can be classified as affected based on broader criteria than under the definition in § 77.5, which provided that a diagnosis could only be made when an official test or a post mortem examination was conducted. Therefore, we expect that the new definition will eliminate time constraints, confusion, and differing standards between cattle, bison, and cervids. The new definition also will expand the types of evidence or information that can be considered by a professional veterinary diagnostician when examining herds. Moreover, a designated tuberculosis epidemiologist (DTE), which is already defined in § 77.2, is designated by the Administrator of the Animal and Plant Health Inspection Service to use and interpret diagnostic tests for tuberculosis and the management of tuberculosis affected herds. Thus, a DTE has the expertise necessary to appropriately apply the new definition. A second commenter suggested that the words “in domestic livestock” should be added to the definition after the words “association with known sources of infection.” We disagree and believe that this language would hinder the diagnosis of tuberculosis as it would eliminate consideration of contacts with infected animals outside of domestic livestock, such as wild animals. For example, in Michigan, wild deer have passed tuberculosis to domestic livestock. Under such circumstances, the suggested limiting language might prevent the introduction of evidence indicating tuberculosis in wildlife populations and possibly slow or deter the detection of the disease in regulated animals. Another commenter pointed out that the definition in the proposed rule differed slightly from the definition of *affected herd* set forth in a draft update of the UMR, that is currently under consideration. The commenter suggested that we revise the definition in the regulations to match the definition of *affected herd* in the draft UMR update. We agree that the definitions in the regulations and the draft UMR update should be the same. In this final rule, we have slightly modified the definition so that it refers to “epidemiologic evidence such as contact with known sources of infection” rather than naming “epidemiologic evidence” and “association with known sources of infection” as separate considerations. The definition as presented in this final rule will be added to the draft UMR update. Therefore, for the reasons given in the proposed rule and in this document, we are adopting the proposed rule as a final rule, with the changes discussed in this document. Executive Order 12866 and Regulatory Flexibility Act This rule has been reviewed under Executive Order 12866. The rule 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. We are amending the tuberculosis regulations by removing the two different definitions of *affected herd* and replacing them with a single, updated definition. This action is necessary because the definitions that have appeared in the regulations are out-of-date and inconsistent. This action will provide more clarity to the regulations. No economic benefits or costs are associated with this action, which would simply update and clarify our definition of *affected herd.* This action would have no effect on small entities, other Federal agencies, State governments, or local governments. Under these circumstances, the Administrator of the Animal and Plant Health Inspection Service has determined that this action will not have a significant economic impact on a substantial number of small entities. Executive Order 12372 This program/activity is listed in the Catalog of Federal Domestic Assistance under No. 10.025 and is subject to Executive Order 12372, which requires intergovernmental consultation with State and local officials. (See 7 CFR part 3015, subpart V.) Executive Order 12988 This final rule has been reviewed under Executive Order 12988, Civil Justice Reform. This rule:

(1)Preempts all State and local laws and regulations that are in conflict with this rule;

(2)has no retroactive effect; and

(3)does not require administrative proceedings before parties may file suit in court challenging this rule. Paperwork Reduction Act This final rule contains no information collection or recordkeeping requirements under the Paperwork Reduction Act of 1995 (44 U.S.C. 3501 *et seq.* ). List of Subjects in 9 CFR Part 77 Animal diseases, Bison, Cattle, Reporting and recordkeeping requirements, Transportation, Tuberculosis. Accordingly, we are amending 9 CFR part 77 as follows: PART 77—TUBERCULOSIS 1. The authority citation for part 77 continues to read as follows: Authority: 7 U.S.C. 8301-8317; 7 CFR 2.22, 2.80, and 371.4. 2. Section 77.2 is amended by adding, in alphabetical order, a definition of *affected herd* to read as follows: § 77.2 Definitions. *Affected herd.* A herd of livestock in which there is strong and substantial evidence that *Mycobacterium bovis* exists. This evidence should include, but is not limited to, any of the following: Histopathology, polymerase chain reaction

(PCR)assay, bacterial isolation or detection, testing data, or epidemiologic evidence such as contact with known sources of infection. §§ 77.5 and 77.20 [Amended] 3. Sections 77.5 and 77.20 are amended by removing the definitions of *affected herd.* Done in Washington, DC, this 14th day of October 2005. Elizabeth E. Gaston, Acting Administrator, Animal and Plant Health Inspection Service. [FR Doc. 05-20974 Filed 10-19-05; 8:45 am]

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