Unknown. Final rule

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--- schema: federal-register doc_type: fedreg source_file: FR-2002-04-15.xml --- 67 72 Monday, April 15, 2002 Contents Agricultural Agricultural Marketing Service NOTICES Canned apples; grade standards, 18162-18163 02-9053 Agriculture Agriculture Department See Agricultural Marketing Service See Forest Service NOTICES Tariff-rate quotas: Raw cane sugar and imported sugars, syrups, and molasses, 18162 02-9054 Alcohol Alcohol, Tobacco and Firearms Bureau RULES Organization, functions, and authority delegations:

Appropriate ATF officers, 18086-18090 02-8869 NOTICES Organization, functions, and authority delegations: Subordinate ATF officials, 18300-18303 02-8870 Army Army Department See Engineers Corps NOTICES Meetings: U.S. Military Academy, Board of Visitors, 18179 02-9074 Census Census Bureau NOTICES Agency information collection activities: Proposed collection; comment request, 18164-18165 02-8993 Centers Centers for Disease Control and Prevention NOTICES Grants and cooperative agreements; availability, etc.:

Human transmissible spongiform encephalopathies; determination of incidence in U.S.; research program, 18207-18209 02-9010 Reports and guidance documents; availability, etc.: Nuclear weapons tests of U.S. and other nations; feasibility study of health consequences to American population, 18209 02-9011 Centers Centers for Medicare & Medicaid Services NOTICES Grants and cooperative agreements; availability, etc.: Medicare— Medicare+Choice Program; Medicare Preferred Provider Organization Demonstrations, 18209-18216 02-9196 Reports and guidance documents; availability, etc.:

Health insurance reform; electronic transaction standards; model compliance plan, 18216-18227 02-9197 Children Children and Families Administration See Community Services Office Commerce Commerce Department See Census Bureau See Export Administration Bureau See International Trade Administration See National Oceanic and Atmospheric Administration See Patent and Trademark Office Community Community Services Office NOTICES Grants and cooperative agreements; availability, etc.: Assets for Independence Demonstration Program, 18311-18354 02-8717 Copyright Copyright Office, Library of Congress PROPOSED RULES Copyright office and procedures:

Sound recordings under statutory license; notice to owners of use of their work Public roundtable, 18148-18149 02-9207 Customs Customs Service NOTICES Tariff classification standards: Unisex footwear, 18303-18304 02-8987 Defense Defense Department See Army Department See Engineers Corps See Navy Department RULES Civilian health and medical program of uniformed services (CHAMPUS): TRICARE program— Medically underserved areas; bonus payments, 18114-18115 02-8586 PROPOSED RULES Acquisition regulations:

Anticompetitive teaming, 18160 02-9050 Defense supply contracts; Balance of Payments Program, 18161 02-9051 NOTICES Agency information collection activities: Proposed collection; comment request, 18177-18178 02-9052 Federal Acquisition Regulation (FAR): Agency information collection activities— Proposed collection; comment request, 18178-18179 02-8977 02-8978 Education Education Department NOTICES Agency information collection activities: Proposed collection; comment request, 18182 02-9002 Employment Employment and Training Administration NOTICES Grants and cooperative agreements; availability, etc.:

Youth Development Practitioner Apprenticeship Initiative, 18243-18253 02-9088 Energy Energy Department See Federal Energy Regulatory Commission NOTICES Floodplain and wetlands protection; environmental review determinations; availability, etc.: Pantex Plant, TX; Zone 13 sewage treatment plant deactivation and demolition, 18182-18183 02-9019 Engineers Engineers Corps NOTICES Environmental statements; availability, etc.: Platte West Water Production Facilities, NE, 18179-18180 02-9073 EPA Environmental Protection Agency RULES Air quality implementation plans; approval and promulgation; various States:

Illinois, 18115-18117 02-8948 PROPOSED RULES Air quality implementation plans; approval and promulgation; various States: Illinois, 18149-18150 02-8949 Pesticides; tolerances in food, animal feeds, and raw agricultural commodities: Acephate, etc., 18150-18160 02-9070 NOTICES Pesticide registration, cancellation, etc.: Acephate; correction, 18196-18197 02-9072 Reports and guidance documents; availability, etc.: Urea; tolerance reassessment progress, 18197-18202 02-9071 Superfund; response and remedial actions, proposed settlements, etc.:

Malvern TCE Site, PA, 18202-18203 02-9069 Executive Executive Office of the President See Management and Budget Office MISSING FOR: Export Administration Bureau Export Administration Bureau NOTICES Meetings: Information Systems Technical Advisory Committee, 18165 02-8994 FAA Federal Aviation Administration PROPOSED RULES Airworthiness directives: Univair Aircraft Corp., 18141-18145 02-8989 Federal Election Federal Election Commission NOTICES Meetings; Sunshine Act, 02-9162 18203 02-9163 Federal Energy Federal Energy Regulatory Commission NOTICES Agency information collection activities:

Proposed collection; comment request, 18183-18184 02-9025 Electric rate and corporate regulation filings: Wallula Generation, LLC, et al., 18190-18191 02-9020 Environmental statements; availability, etc.: Aquenergy Systems, Inc., 18191 02-9036 PPL Great Works, LLC, 18191 02-9035 Environmental statements; notice of intent: Newton Falls Holdings, LLC, 18192 02-9038 Hydroelectric applications, 18192-18195 02-9026 02-9027 02-9028 02-9037 Meetings: Regional Transmission Organizations— State-Federal Southeast Regional Panel, 18195 02-9033 Practice and procedure:

Off-the-record communications, 18195-18196 02-9034 *Applications, hearings, determinations, etc.:* Anadarko Gathering Co. et al., 18184 02-9031 ANR Pipeline Co., 02-9045 18184 02-9046 Aquila Storage & Transportation, LP, 18184-18185 02-9021 Columbia Gulf Transmission Co., 18185 02-9030 East Tennessee Natural Gas Co., 18186 02-9032 El Paso Natural Gas Co. et al., 18186-18187 02-9039 Enogex, Inc., 18187 02-9029 Florida Gas Transmission Co., 18187 02-9022 Indeck-Oswego L.P., 18187-18188 02-9024 Kern River Gas Transmission Co., 18188 02-9040 Natural Gas Pipeline Co. of America, 18188 02-9044 New York Independent System Operator, Inc., et al., 18188-18189 02-9023 Questar Pipeline Co., 18189 02-9042 TransColorado Gas Transmission Co., 18189 02-9043 Vector Pipeline L.P., 18189-18190 02-9041 Federal Reserve Federal Reserve System NOTICES Agency information collection activities:

Proposed collection; comment request; correction, 18203-18204 02-9007 Fish Fish and Wildlife Service RULES Endangered and threatened species: Critical habitat designations— Quino checkerspot butterfly, 18355-18395 02-8525 Food Food and Drug Administration RULES Animal drugs, feeds, and related products: Furosemide, 18086 02-9014 Sometribove zinc suspension, 18085 02-9015 NOTICES Agency information collection activities: Reporting and recordkeeping requirements, 18227 02-9097 Grants and cooperative agreements; availability, etc.:

Food safety research, 18227-18230 02-9098 Meetings: Prescription drugs; risk management; public hearing, 18230-18232 02-9096 Forest Forest Service NOTICES Agency information collection activities: Proposed collection; comment request, 18163-18164 02-9016 GSA General Services Administration NOTICES Environmental statements; notice of intent: Suitland, MD; Census Bureau building at Suitland Federal Center, 18204-18205 02-8976 Federal Acquisition Regulation (FAR): Agency information collection activities— Proposed collection; comment request, 18178-18179 02-8977 02-8978 Federal Management Regulation:

Motor vehicles; tobacco products use in vehicles owned or leased by Federal Government (Bulletin FMR B-3), 18205 02-9003 Geological Geological Survey NOTICES Agency information collection activities: Proposed collection; comment request, 18236-18237 02-9099 Health Health and Human Services Department See Centers for Disease Control and Prevention See Centers for Medicare & Medicaid Services See Community Services Office See Food and Drug Administration See National Institutes of Health See Substance Abuse and Mental Health Services Administration NOTICES Meetings:

Genetic Testing, Secretary's Advisory Committee, 18205-18206 02-9092 Reports and guidance documents; availability, etc.: Elderly people and appropriate use of therapeutic agents; national action plan; comment request, 18206-18207 02-9048 Housing Housing and Urban Development Department PROPOSED RULES Manufactured home construction and safety standards: Housing program fee, 18397-18399 02-9000 NOTICES Agency information collection activities: Submission for OMB review; comment request, 18236 02-9001 Public and Indian housing:

Housing assistance payments (Section 8)— Housing Choice Voucher Program and Moderate Rehabilitation Programs; administrative fees, 18401-18459 02-9049 Indian Indian Affairs Bureau NOTICES Tribal-State Compacts approval; Class III (casino) gambling: Snoqualmie Indian Tribe, WA, 18237 02-9008 Interior Interior Department See Fish and Wildlife Service See Geological Survey See Indian Affairs Bureau See Land Management Bureau See National Park Service International International Trade Administration NOTICES Antidumping:

Carbon and alloy steel wire rod from— Brazil, 18165-18172 02-9215 Extruded rubber thread from— Malaysia, 18172-18173 02-9080 Pure magnesium from— Canada, 18173 02-9079 Tapered roller bearings and parts, finished and unfinished, from— China, 18173-18174 02-9078 Meetings: Exporters’ Textile Advisory Committee, 18174 02-9013 Justice Justice Department See Juvenile Justice and Delinquency Prevention Office Juvenile Juvenile Justice and Delinquency Prevention Office NOTICES Meetings:

Juvenile Justice and Delinquency Prevention Coordinating Council, 18243 02-9004 Labor Labor Department See Employment and Training Administration See Occupational Safety and Health Administration Land Land Management Bureau NOTICES Environmental statements; availability, etc.: Grand Staircase-Escalante National Monument, UT; 3R Minerals Coal Bed Canyon Mine, 18237-18238 02-9047 Realty actions; sales, leases, etc.: Nevada, 18238 02-8888 Recreation management restrictions, etc.:

Piedras Blancas Light Station, CA; supplementary rules, 18238-18240 02-8887 Library Library of Congress See Copyright Office, Library of Congress Management Management and Budget Office NOTICES Federal Activities Inventory Reform Act of 1998; implementation: Agency Inventories of Activities that are not Inherently Governmental; availability, 18255 02-8992 NASA National Aeronautics and Space Administration NOTICES Federal Acquisition Regulation (FAR): Agency information collection activities— Proposed collection; comment request, 18178-18179 02-8977 02-8978 National Archives National Archives and Records Administration PROPOSED RULES Public availability and use:

NARA facilities; addresses and hours, 18146-18148 02-9018 National Credit National Credit Union Administration NOTICES Meetings; Sunshine Act, 18253 02-9214 NIH National Institutes of Health NOTICES Inventions, Government-owned; availability for licensing, 18232-18234 02-9094 Meetings: National Institute of Mental Health, 18234 02-9090 Scientific Review Center, 18234 02-9091 Patent licenses; non-exclusive, exclusive, or partially exclusive: Trophogen, 18234-18235 02-9093 NOAA National Oceanic and Atmospheric Administration RULES Fishery conservation and management:

Alaska; fisheries of Exclusive Economic Zone— Bering Sea and Aleutian Islands groundfish, 18129-18140 02-8961 West Coast States and Western Pacific fisheries— Pacific whiting, 18117-18129 02-9083 NOTICES Meetings: Mid-Atlantic Fishery Management Council, 18174-18175 02-9084 Pacific Fishery Management Council, 02-9085 18175-18176 02-9086 Western Pacific Fishery Management Council, 18176 02-9087 National Park National Park Service NOTICES Native American human remains and associated funerary objects:

Arkansas Archeological Survey, AR— Inventory from Clark County et al., AR, 18240-18243 02-9095 National Science National Science Foundation NOTICES Antarctic Conservation Act of 1978; permit applications, etc.:, 18253 02-8995 Navy Navy Department NOTICES Environmental statements; availability, etc.: Pearl Harbor, HI; Ford Island development, 18180-18182 02-9082 Nuclear Nuclear Regulatory Commission NOTICES *Applications, hearings, determinations, etc.:* Private Fuel Storage, L.L.C., 18253-18255 02-9081 Occupational Occupational Safety and Health Administration RULES Construction safety and health standards:

Signs, signals, and barricades, 18091-18112 02-8773 PROPOSED RULES Construction safety and health standards: Signs, signals, and barricades, 18145-18146 02-8774 Office Office of Management and Budget See Management and Budget Office Patent Patent and Trademark Office NOTICES Trademark Manual of Examining Procedure; publication in electronic format; comment request, 18176-18177 02-9017 Pension Pension Benefit Guaranty Corporation RULES Single-employer plans: Allocation of assets— Interest assumptions for valuing and paying benefits, 18112-18114 02-9064 NOTICES Multiemployer and single-employer plans:

Interest rates and assumptions, 18255-18256 02-9065 Personnel Personnel Management Office NOTICES Agency information collection activities: Submission for OMB review; comment request, 18256-18257 02-9009 Public Public Health Service See Centers for Disease Control and Prevention See Food and Drug Administration See National Institutes of Health See Substance Abuse and Mental Health Services Administration SEC Securities and Exchange Commission NOTICES Investment Company Act of 1940:

Exemption applications— Sage Life Assurance of America, Inc., et al., 18257-18261 02-9056 Shares substitution applications— American Enterprise Life Insurance Co. et al., 18261-18272 02-9089 Self-regulatory organizations; proposed rule changes: American Stock Exchange LLC, 18272-18278 02-8999 02-9057 National Association of Securities Dealers, Inc., 18278-18285 02-8997 02-8998 02-9063 New York Stock Exchange, Inc., 18285 02-9062 Pacific Exchange, Inc., 18285-18289 02-9061 Philadelphia Stock Exchange, Inc., 18289-18298 02-9058 02-9059 02-9060 *Applications, hearings, determinations, etc.:* Kinam Gold Inc., 18257 02-8996 SBA Small Business Administration NOTICES Disaster loan areas:

Massachusetts, 18298 02-9077 Tennessee, 18298-18299 02-9075 Virginia, 18299 02-9076 Social Social Security Administration NOTICES Meetings: Ticket to Work and Work Incentives Advisory Panel, 18299-18300 02-8974 Substance Substance Abuse and Mental Health Services Administration NOTICES Agency information collection activities: Submission for OMB review; comment request, 18235-18236 02-9012 Transportation Transportation Department See Federal Aviation Administration Treasury Treasury Department See Alcohol, Tobacco and Firearms Bureau See Customs Service Veterans Veterans Affairs Department NOTICES Agency information collection activities:

Proposed collection; comment request, 18304-18307 02-8979 02-8980 02-8981 02-8985 02-9006 Submission for OMB review; comment request, 02-8982 18307-18308 02-8983 02-8984 Real property; enhanced-use leases: Hillsborough, NJ; Somerville Asset Management Service facility, 18308-18309 02-8986 Separate Parts In This Issue Part II Children and Families Administration, Community Services Office, 18311-18354 02-8717 Part III Interior Department, Fish and Wildlife Service, 18355-18395 02-8525 Part IV Housing and Urban Development Department, 18397-18399 02-9000 Part V Housing and Urban Development Department, 18401-18459 02-9049 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. 67 72 Monday, April 15, 2002 Rules and Regulations DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration 21 CFR Part 522 Implantation or Injectable Dosage Form New Animal Drugs; Sometribove Zinc Suspension AGENCY:

Food and Drug Administration, HHS. ACTION: Final rule. SUMMARY: The Food and Drug Administration

(FDA)is amending the animal drug regulations to reflect approval of a supplemental new animal drug application

(NADA)filed by Monsanto Co. which provides for subcutaneous injection of sometribove zinc suspension in healthy lactating dairy cows to increase the production of marketable milk with no restriction on injection site. Three injection sites are recommended. DATES: This rule is effective April 15, 2002. FOR FURTHER INFORMATION CONTACT: Suzanne J. Sechen, Center for Veterinary Medicine (HFV-126), Food and Drug Administration, 7500 Standish Pl., Rockville, MD 20855, 301-827-0221, e-mail: *ssechen@cvm.fda.gov.* SUPPLEMENTARY INFORMATION: Monsanto Co., 800 North Lindbergh Blvd., St. Louis, MO 63167, filed a supplement to NADA 140-872 that provides for the use of POSILAC 1 STEP (sometribove zinc suspension) in healthy lactating dairy cows to increase the production of marketable milk. The supplemental NADA provides for subcutaneous injection with no restriction on injection site. Three injection sites are recommended: The neck area, the postscapular region, or the depression on either side of the tailhead. The application is approved as of December 27, 2001, and the regulations are amended in § 522.2112 (21 CFR 522.2112) to reflect the approval. The basis of approval is discussed in the freedom of information summary. Section 522.2112 is also being amended to provide for changes to the conditions of use approved November 4, 1997. These changes included the use of sometribove zinc suspension beginning during the 9th or 10th week after calving, and the removal of, or changes in, precautionary statements from labeling pertaining to certain reproductive disorders. In accordance with the freedom of information provisions of 21 CFR part 20 and 514.11(e)(2)(ii), a summary of safety and effectiveness data and information submitted to support approval of this application may be seen in the Dockets Management Branch (HFA-305), Food and Drug Administration, 5630 Fishers Lane, rm. 1061, Rockville, MD 20852, between 9 a.m. and 4 p.m., Monday through Friday. The agency has determined under 21 CFR 25.33(a)(1) 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. This rule does not meet the definition of “rule” in 5 U.S.C. 804(3)(A) because it is a rule of “particular applicability.” Therefore, it is not subject to the congressional review requirements in 5 U.S.C. 801-808. List of Subjects in 21 CFR Part 522 Animal drugs. Therefore, under the Federal Food, Drug, and Cosmetic Act and under authority delegated to the Commissioner of Food and Drugs and redelegated to the Center for Veterinary Medicine, 21 CFR part 522 is amended as follows: PART 522—IMPLANTATION OR INJECTABLE DOSAGE FORM NEW ANIMAL DRUGS 1. The authority citation for 21 CFR part 522 continues to read as follows: Authority: 21 U.S.C. 360b. 2. Section 522.2112 is amended by revising the section heading and paragraph (a), by removing paragraph (c), by redesignating paragraph

(d)as paragraph (c), and by revising newly redesignated paragraphs (c)(1) and (c)(3) to read as follows: § 522.2112 Sometribove zinc suspension.

(a)*Specifications.* Each single-dose syringe contains 500 milligrams

(mg)sometribove zinc in a prolonged-release suspension.

(c)*Conditions of use* —(1) *Amount.* Inject 500 mg every 14 days beginning during the 9th or 10th week (57 to 70 days) after calving and continue until the end of lactation.

(3)*Limitations.* For use in lactating dairy cows only. Safety to replacement bulls born to treated dairy cows has not been established. Administer subcutaneously. To minimize injection site blemishes on carcass at time of slaughter, avoid injections within 2 weeks of expected slaughter. No milk discard or preslaughter withdrawal period is required. Use may result in reduced pregnancy rates and, in first calf heifers, an increase in days open. The incidence of retained placenta may be higher. Treated cows are at an increased risk for clinical mastitis and subclinical mastitis. In some herds, use has been associated with increases in somatic cell counts in milk. Care should be taken to differentiate increased body temperature due to use of this product from an increased body temperature that may occur due to illness. Use may result in an increase in digestive disorders such as indigestion, bloat, and diarrhea. There may be an increase in the number of cows experiencing periods of “off-feed” (reduced feed intake) during treatment. Cows treated with this product may have increased numbers of enlarged hocks and lesions of the knee (carpal region), and second lactation or older cows may have more disorders of the foot region. Use has been associated with reductions in hemoglobin and hematocrit values during treatment. Human warning: Avoid prolonged or repeated contact with eyes and skin. Dated: March 21, 2002. Andrew J. Beaulieu, Acting Director, Office of New Animal Drug Evaluation, Center for Vetrinary Medicine. [FR Doc. 02-9015 Filed 4-12-02; 8:45 am]

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