Unknown. Final rule

2,131 words·~10 min read·/register/2003/05/21/03-12721·

A research copy — for the controlling text, always check the official state or federal source. Not legal advice.

--- schema: federal-register doc_type: fedreg source_file: FR-2003-05-21.xml --- 68 98 Wednesday, May 21, 2003 Contents Agriculture Agriculture Department See Forest Service See Rural Business-Cooperative Service NOTICES Agency information collection activities; proposals, submissions, and approvals, 27778-27780 03-12728 Antitrust Antitrust Division NOTICES Competitive impact statements and proposed consent judgments: Univision Communications Inc., 27851-27863 03-12746 Village Voice Media, LLC, et al., 27863-27864 03-12745 National cooperative research notifications:

Global Climate and Energy Project, 27865 03-12747 Arts Arts and Humanities, National Foundation See National Foundation on the Arts and the Humanities Centers Centers for Disease Control and Prevention NOTICES Grants and cooperative agreements; availability, etc.: Birth defects— Clinical Practices to Prevent Birth Defects and Developmental Disabilities to Promote Health Among Women with Disabilities Program, 27808-27810 03-12709 Duchenne and Becker Muscular Dystrophy and other single gene disorders; surveillance and epidemiologic research, 27810-27813 03-12708 Meetings:

Disease, Disability, and Injury Prevention and Control Special Emphasis Panels, 27813 03-12706 Centers Centers for Medicare & Medicaid Services NOTICES Medicaid: State plan amendments, reconsideration; hearings— Arkansas, 27815-27816 03-12698 Michigan, 27813-27815 03-12697 Children Children and Families Administration NOTICES Grants and cooperative agreements; availability, etc.: Help America Vote Act— Election Assistance for Individuals with Disabilities Program, 27816-27818 03-12699 Coast Guard Coast Guard RULES Ports and waterways safety:

Des Plaines River, Joliet, IL; regulated navigation area, 27727-27729 03-12687 Commerce Commerce Department See International Trade Administration See National Oceanic and Atmospheric Administration See Patent and Trademark Office CITA Committee for the Implementation of Textile Agreements NOTICES Cotton, wool, and man-made textiles: China, 27787-27789 03-12893 Comptroller Comptroller of the Currency PROPOSED RULES National banks: Securities; reporting and disclosure requirements, 27753-27757 03-12259 Defense Defense Department See Navy Department Education Education Department NOTICES Agency information collection activities; proposals, submissions, and approvals, 27790-27791 03-12696 Energy Energy Department NOTICES Grants and cooperative agreements; availability, etc.:

Biological and Environmental Research Office programs— Genomic sequencing targets; input and nominations request, 27791-27793 03-12715 EPA Environmental Protection Agency RULES Pesticides; tolerances in food, animal feeds, and raw agricultural commodities: Indoxacarb, 27740-27746 03-12480 Pyraflufen-ethyl, 27729-27740 03-12359 Superfund program: National oil and hazardous substances contingency plan— National priorities list update, 27746-27747 03-12476 NOTICES Agency information collection activities; proposals, submissions, and approvals, 27793-27797 03-12759 03-12763 Meetings:

Environmental Policy and Technology National Advisory Council, 27797-27799 03-12484 Pesticide, food, and feed additive petitions: Interregional Research Project (No. 4), 27799-27802 03-12485 Pesticides; emergency exemptions, etc.: Carbofuran, 27802-27805 03-12483 Pesticides; experimental use permits, etc.: HBB Partnership, 27805 03-12481 Reports and guidance documents; availability, etc.: Review of reference dose and reference concentration processes, 27805-27806 03-12762 Superfund; response and remedial actions, proposed settlements, etc.:

Southern Solvents Site, FL, 27806 03-12767 Water pollution; discharge of pollutants (NPDES): Alaska; oil and gas extraction facilities on north slope of Brooks Range; general permit, 27806-27807 03-12764 Executive Executive Office of the President See Presidential Documents See Trade Representative, Office of United States Farm Farm Credit Administration PROPOSED RULES Farm credit system: Financing eligibility and scope, loan policies and operations, and general provisions— Credit and related services; miscellaneous amendments, 27757-27760 03-12631 FCC Federal Communications Commission PROPOSED RULES Digital television stations; table of assignments:

Montana, 27767-27768 03-12685 FMC Federal Maritime Commission NOTICES Agreements filed, etc., 27807 03-12750 Ocean transportation intermediary licenses: Uraycar Transport Services, Inc., et al., 27807-27808 03-12749 Fish Fish and Wildlife Service NOTICES Comprehensive conservation plans; availability, etc: Noxubee National Wildlife Refugee, MS, 27840-27841 03-12710 Environmental statements; availability, etc.: Incidental take permits— Riverside County, CA; coastal California gnatcatcher, 27841-27842 03-12679 Food Food and Drug Administration RULES Animal drugs, feeds, and related products:

Bambermycins, 27727 03-12721 NOTICES Agency information collection activities; proposals, submissions, and approvals, 27818-27822 03-12717 03-12724 03-12725 Reports and guidance documents; availability, etc.: FDA Modernization Act of 1997— Drug and biologics firms conducting postmarketing commitment studies; performance report, 27822-27823 03-12720 Forest Forest Service NOTICES Environmental statements; notice of intent: Wallowa-Whitman National Forest, OR; withdrawn, 27780 03-12702 Meetings:

Resource Advisory Committees— Sanders County, 27780 03-12737 Health Health and Human Services Department See Centers for Disease Control and Prevention See Centers for Medicare & Medicaid Services See Children and Families Administration See Food and Drug Administration See Health Resources and Services Administration See National Institutes of Health Health Health Resources and Services Administration NOTICES Grants and cooperative agreements; availability, etc.: Continuing Clinical Education Program in Pacific Basin; planning, development, implementation, and operation, 27823-27826 03-12774 National Vaccine Injury Compensation Program:

Petitions received, 27826-27836 03-12773 Homeland Homeland Security Department See Coast Guard See Transportation Security Administration Housing Housing and Urban Development Department NOTICES Agency information collection activities; proposals, submissions, and approvals, 27838-27840 03-12682 03-12684 Interior Interior Department See Fish and Wildlife Service See Land Management Bureau See Minerals Management Service See Surface Mining Reclamation and Enforcement Office IRS Internal Revenue Service NOTICES Meetings:

Taxpayer Advocacy Panels; correction, 27884-27885 03-12777 International International Trade Administration NOTICES Antidumping: Stainless steel sheet and strip in coils from— Taiwan, 27782-27783 03-12768 Antidumping and countervailing duties: Administrative review requests, 27781-27782 03-12769 Justice Justice Department See Antitrust Division See National Institute of Corrections NOTICES Grants and cooperative agreements; availability, etc.: Community Oriented Policing Services Office— Community policing discretionary grants (2002 FY), 27846-27851 03-12692 Land Land Management Bureau NOTICES Meetings:

Wild Horse and Burro Advisory Board, 27842-27843 03-12680 Minerals Minerals Management Service NOTICES Agency information collection activities; proposals, submissions, and approvals, 27843-27845 03-12693 Royalty management: Indian gas production in designated areas not associated with index zones; additional royalty payments; major portion prices and due dates; correction, 27845 03-12714 NASA National Aeronautics and Space Administration NOTICES Meetings: Advisory Council Aerospace Technology Advisory Committee, 27865 03-12726 National Foundation National Foundation on the Arts and the Humanities NOTICES Meetings:

Humanities Panel, 27865-27866 03-12770 Senior Executive Service: Performance Review Board; membership, 27866 03-12771 National Institute National Institute of Corrections NOTICES Meetings: Advisory Board, 27865 03-12744 NIH National Institutes of Health NOTICES Meetings: National Cancer Institute, 03-12754 27836-27837 03-12756 03-12758 National Institute of Child Health and Human Development, 27838 03-12755 National Institute of Mental Health, 27837 03-12753 National Institute on Aging, 27838 03-12757 NOAA National Oceanic and Atmospheric Administration PROPOSED RULES Fishery conservation and management:

Northeastern United States fisheries— Northeast multispecies, 27774-27777 03-12742 Summer flounder, scup, and black sea bass, 27768-27773 03-12647 NOTICES Agency information collection activities; proposals, submissions, and approvals, 27783-27784 03-12738 Electronic Navigation Charts released as Nautical Charts; digital navigation and associated data; distribution to public on Internet, 27784-27785 03-12703 Meeting: North Pacific Fishery Management Council, 27785-27786 03-12740 Meetings:

Gulf of Mexico Fishery Management Council et al., 27786 03-12741 Permits: Foreign fishing, 27787 03-12739 National Science National Science Foundation NOTICES Antarctic Conservation Act of 1978; permit applications, etc., 27866 03-12694 Navy Navy Department NOTICES Base realignment and closure: Surplus Federal property— Naval Air Station, Key West, FL; withdrawn, 27790 03-12704 Inventions, Government-owned; availability for licensing, 27790 03-12705 Office of U.S. Trade Office of United States Trade Representative See Trade Representative, Office of United States Patent Patent and Trademark Office NOTICES Patents:

Human drug products: Ranolazine; interim term extension, 27787 03-12729 Postal Postal Service PROPOSED RULES Domestic Mail Manual: Customized MarketMail; mailing nonrectangular- or irregular-shaped items; classification change, 27760-27767 03-12719 Presidential Presidential Documents PROCLAMATIONS *Special observances:* World Trade Week (Proc. 7679), 27887-27890 03-12945 Railroad Railroad Retirement Board NOTICES Agency information collection activities; proposals, submissions, and approvals, 27866-27867 03-12691 Rural Rural Business-Cooperative Service NOTICES Agency information collection activities; proposals, submissions, and approvals, 27780-27781 03-12760 SEC Securities and Exchange Commission NOTICES Regulatory responsibility allocation program:

National Association of Securities Dealers, Inc., et al., 27869-27872 03-12730 Self-regulatory organizations; proposed rule changes: American Stock Exchange LLC, 27872-27876 03-12690 03-12735 Depository Trust Co., 27876-27879 03-12731 03-12732 National Association of Securities Dealers, Inc., 27879-27880 03-12689 National Securities Clearing Corp., 27880-27882 03-12733 03-12734 *Applications, hearings, determinations, etc.:* MainStay Funds, et al., 27867-27869 03-12736 SBA Small Business Administration NOTICES Disaster loan areas:

Alabama, 27882 03-12701 Kansas, 27882 03-12751 Mississippi, 27883 03-12752 Texas, 27883 03-12700 State State Department NOTICES Art objects; importation for exhibition: Anne Frank the Writer: An Unfinished Story, 27883 03-12895 Surface Surface Mining Reclamation and Enforcement Office NOTICES Agency information collection activities; proposals, submissions, and approvals, 27845-27846 03-12772 Textile Textile Agreements Implementation Committee See Committee for the Implementation of Textile Agreements Trade Trade Representative, Office of United States NOTICES Dominican Republic; reinstatement of government procurement treatment of products, 27883 03-12727 Security Transportation Security Administration RULES Aviation security infrastructure fees, 27747-27752 03-12775 Treasury Treasury Department See Comptroller of the Currency See Internal Revenue Service NOTICES Agency information collection activities; proposals, submissions, and approvals, 27883-27884 03-12716 Separate Parts In This Issue Part II Executive Office of the President, Presidential Documents, 27887-27890 03-12945 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. 68 98 Wednesday, May 21, 2003 Rules and Regulations DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration 21 CFR Part 558 New Animal Drugs for Use in Animal Feeds; Bambermycins 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 Intervet, Inc. The supplemental NADA provides for use of bambermycins Type A medicated articles to make Type B and Type C medicated feeds used to increase rate of weight gain in pasture cattle (slaughter, stocker, feeder cattle, and dairy and beef replacement heifers) when consumed free-choice or hand-fed at a rate of not less than 10 milligrams

(mg)nor more than 40 mg bambermycins per head per day. DATES: This rule is effective May 21, 2003. FOR FURTHER INFORMATION CONTACT: Eric S. Dubbin, Center for Veterinary Medicine (HFV-126), Food and Drug Administration, 7500 Standish Pl., Rockville, MD 20855, 301-827-0232, e-mail: *edubbin@cvm.fda.gov* . SUPPLEMENTARY INFORMATION: Intervet, Inc., PO Box 318, 405 State St., Millsboro, DE 19966, filed a supplement to NADA 141-034 that provides for use of GAINPRO (bambermycins) Type A medicated articles to make Type B and Type C medicated feeds used to increase rate of weight gain in pasture cattle (slaughter, stocker, feeder cattle, and dairy and beef replacement heifers) when consumed free-choice or hand-fed at a rate of not less than 10 mg nor more than 40 mg bambermycins per head per day. The supplemental NADA is approved as of February 10, 2003, and the regulations are amended in 21 CFR 558.95 to reflect the approval. The basis of approval is discussed in the freedom of information summary. In accordance with the freedom of information provisions of 21 CFR part 20 and 21 CFR 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 carefully considered the potential environmental impact of this action and has concluded that the action will not have a significant impact on the human environment and that an environmental impact statement is not required. FDA's finding of no significant impact and the evidence supporting that finding, contained in an environmental assessment, may be seen in the Dockets Management Branch between 9 a.m. and 4 p.m., Monday through Friday. 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 558 Animal drugs, Animal feeds. 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 558 is amended as follows: PART 558—NEW ANIMAL DRUGS FOR USE IN ANIMAL FEEDS 1. The authority citation for 21 CFR part 558 continues to read as follows: Authority: 21 U.S.C. 360b, 371. § 558.95 [Amended] 2. Section 558.95 *Bambermycins* is amended by: a. In paragraphs (d)(4)(ii)( *b* ) and (d)(4)(iv)( *a* ) by removing “20” and by adding in its place “40”; b. In paragraph (d)(4)(iii)( *d* ) by adding “cattle, and dairy and beef replacement heifers” after “feeder”, and by removing “5.33” and “10- to 20-milligrams” and by adding in their respective places “10.66” and “10 to 40 milligrams”; and c. In paragraphs (d)(4)(ii)( *b* ), (d)(4)(iii)( *d* ), and (d)(4)(iv)( *c* ) by adding “Daily bambermycins intakes in excess of 20 mg/head/day have not been shown to be more effective than 20 mg/head/day.” at the end of the paragraph. Dated: May 8, 2003. Steven D. Vaughn, Director, Office of New Animal Drug Evaluation, Center for Veterinary Medicine. [FR Doc. 03-12721 Filed 5-20-03; 8:45 am]

Connectionstraces to 4

Traces to 4 documents

CFR

U.S. Code

3 references not yet in our index