Federal Register / Vol. 66, No. 215 / Tuesday, November 6, 2001 / Rules and Regulations 56035
new address is 5100 Paint Branch This rule does not meet the definition Medicine (HFV–102), Food and Drug Pkwy., College Park, MD 20740. of ‘‘rule’’ in 5 U.S.C. 804(3)(A) because Administration, 7500 Standish Pl., Publication of this document it is a rule of ‘‘particular applicability.’’ Rockville, MD 20855, 301–827–0209. constitutes final action on these changes Therefore, it is not subject to the SUPPLEMENTARY INFORMATION: Elanco under the Administrative Procedure Act congressional review requirements in 5 Animal Health, A Division of Eli Lilly (5 U.S.C. 553). Notice and public U.S.C. 801-808. & Co., Lilly Corporate Center, procedure are unnecessary because FDA List of Subjects in 21 CFR Part 510 Indianapolis, IN 46285, has informed is merely correcting nonsubstantive FDA that it has transferred to Ivy Administrative practice and errors. Laboratories, Div. of Ivy Animal Health, procedure, Animal drugs, Labeling, Therefore, under the Federal Food, Inc., 8857 Bond St., Overland Park, KS Reporting and recordkeeping Drug, and Cosmetic Act and under 66214, ownership of, and all rights and requirements. authority delegated to the Commissioner interests in NADA 118–123 for of Food and Drugs, 21 CFR chapter I is Therefore, under the Federal Food, COMPUDOSE 200 (estradiol) and amended as follows: Drug and Cosmetic Act and under COMPUDOSE 400 implants for cattle. 1. Parts 1, 5, 10, 70, 71, 73, 80, 100, authority delegated to the Commissioner Accordingly, the agency is amending 101, 102, 106, 107, 108, 109, 110, 130, of Food and Drugs and redelegated to 161, 165, 170, 172, 173, 175, 176, 177, the regulations in 21 CFR 522.840 to the Center for Veterinary Medicine, 21 reflect the transfer of ownership. 178, 180, 181, 184, 189, 190, 211, 701, CFR part 510 is amended as follows: 1240, and 1250 are amended by This rule does not meet the definition removing ‘‘200 C Street, SW., PART 510—NEW ANIMAL DRUGS of ‘‘rule’’ in 5 U.S.C. 804(3)(A) because Washington, DC 20204’’ or ‘‘200 C St. it is a rule of ‘‘particular applicability.’’ 1. The authority citation for 21 CFR SW., Washington, DC 20204’’ wherever Therefore, it is not subject to the part 510 continues to read as follows: they appear and by adding in their place congressional review requirements in 5 ‘‘5100 Paint Branch Pkwy., College Park, Authority: 21 U.S.C. 321, 331, 351, 352, U.S.C. 801–808. MD 20740.’’ 353, 360b, 371, 379e. List of Subjects in 21 CFR Part 522 Dated: October 31, 2001. § 510.600 [Amended] Animal drugs. Margaret M. Dotzel, 2. Section 510.600 Names, addresses, Therefore, under the Federal Food, Associate Commissioner for Policy. and drug labeler codes of sponsors of Drug, and Cosmetic Act and under [FR Doc. 01–27811 Filed 11–5–01; 8:45 am] approved applications is amended in authority delegated to the Commissioner BILLING CODE 4160–01–S the table in paragraph (c)(1) in the entry of Food and Drugs and redelegated to for ‘‘Marsam Pharmaceuticals, Inc.’’ and the Center for Veterinary Medicine, 21 in the table in paragraph (c)(2) in the CFR part 522 is amended as follows: DEPARTMENT OF HEALTH AND entry for ‘‘000209’’ by removing ‘‘Inc.’’ HUMAN SERVICES and by adding in its place ‘‘LLC’’. PART 522—IMPLANTATION OR Dated: October 26, 2001. INJECTABLE DOSAGE FORM NEW Food and Drug Administration Claire M. Lathers, ANIMAL DRUGS 21 CFR Part 510 Director, Office of New Drug Evaluation, 1. The authority citation for 21 CFR Center for Veterinary Medicine. part 522 continues to read as follows: New Animal Drugs; Change of [FR Doc. 01–27813 Filed 11–5–01; 8:45 am] Authority: 21 U.S.C. 360b. Sponsor’s Name BILLING CODE 4160–01–S § 522.840 [Amended] AGENCY: Food and Drug Administration, HHS. DEPARTMENT OF HEALTH AND 2. Section 522.840 Estradiol is amended in paragraph (b) by removing ACTION: Final rule. HUMAN SERVICES ‘‘000986’’ and by adding in its place SUMMARY: The Food and Drug Food and Drug Administration ‘‘No. 021641’’. Administration (FDA) is amending the Dated: October 26, 2001. animal drug regulations to reflect a 21 CFR Part 522 Claire M. Lathers, change of sponsor’s name from Marsam Implantation or Injectable Dosage Office of New Animal Drug Evaluation, Center Pharmaceuticals, Inc., to Marsam for Veterinary Medicine. Pharmaceuticals, LLC. Form New Animal Drugs; Change of [FR Doc. 01–27812 Filed 11–5–01; 8:45 am] DATES: This rule is effective November Sponsor BILLING CODE 4160–01–S 6, 2001. AGENCY: Food and Drug Administration, FOR FURTHER INFORMATION CONTACT: HHS. Lonnie W. Luther, Center for Veterinary ACTION: Final rule. DEPARTMENT OF TRANSPORTATION Medicine (HFV–102), Food and Drug SUMMARY: The Food and Drug Administration, 7500 Standish Pl., Coast Guard Rockville, MD 20855, 301–827–0209, e- Administration (FDA) is amending the animal drug regulations to reflect a mail: [email protected]. 33 CFR Parts 100 and 165 SUPPLEMENTARY INFORMATION: Marsam change of sponsor for an approved new Pharmaceuticals, Inc., Bldg. 31, 24 animal drug application (NADA) from [USCG–2001–10936] Olney Ave., Cherry Hill, NJ 08034, has Elanco Animal Health, A Division of Eli informed FDA of a change of sponsor’s Lilly & Co., to Ivy Laboratories, Div. of Safety Zones, Security Zones, and name to Marsam Pharmaceuticals, LLC. Ivy Animal Health, Inc. Special Local Regulations DATES: Accordingly, the agency is amending This rule is effective November AGENCY: Coast Guard, DOT. the regulations in 21 CFR 510.600(c)(1) 6, 2001. ACTION: Notice of temporary rules and (c)(2) to reflect the change of FOR FURTHER INFORMATION CONTACT: issued. sponsor’s name. Lonnie W. Luther, Center for Veterinary
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SUMMARY: This document provides the docket, contact Dorothy Beard, these special local regulations, security required notice of substantive rules Chief, Dockets, Department of zones, or safety zones by Coast Guard issued by the Coast Guard and Transportation, (202) 366–5149. officials on-scene prior to enforcement temporarily effective between April 1, SUPPLEMENTARY INFORMATION: District action. However, the Coast Guard, by 2001 and June 30, 2001 which were not Commanders and Captains of the Port law, must publish in the Federal published in the Federal Register. This (COTP) must be immediately responsive Register notice of substantive rules quarterly notice lists temporary local to the safety and security needs of the adopted. To meet this obligation regulations, security zones, and safety waters within their jurisdiction; without imposing undue expense on the zones of limited duration and for which therefore, District Commanders and public, the Coast Guard periodically timely publication in the Federal COTPs have been delegated the publishes a list of these temporary Register was not possible. authority to issue certain local special local regulations, security zones, DATES: This notice lists temporary Coast regulations. Safety zones may be and safety zones. Permanent regulations Guard regulations that became effective established for safety or environmental are not included in this list because they and were terminated between April 1, purposes. A safety zone may be are published in their entirety in the 2001 and June 30, 2001. This notice also stationary and described by fixed limits Federal Register. Temporary regulations lists regulations that were effective and or it may be described as a zone around may also be published in their entirety terminated between January 1, 2001, a vessel in motion. Security zones limit if sufficient time is available to do so and March 31, 2001. access to vessels, ports, or waterfront before they are placed in effect or facilities to prevent injury or damage. terminated. The safety zones, special ADDRESSES: The Docket Management Special local regulations are issued to local regulations and security zones Facility maintains the public docket for enhance the safety of participants and listed in this notice have been exempted this notice. Documents indicated in this spectators at regattas and other marine from review under Executive Order notice will be available for inspection or events. Timely publication of these 12866 because of their emergency copying at the Docket Management regulations in the Federal Register is nature, or limited scope and temporary Facility, U.S. Department of often precluded when a regulation effectiveness. Transportation, Room PL–401, 400 responds to an emergency, or when an Seventh Street, SW., Washington, DC The following regulations were placed event occurs without sufficient advance in effect temporarily during the period 20593–0001 between 9 a.m. and 5 p.m., notice. The affected public is, however, April 1, 2001 and June 30, 2001, unless Monday through Friday, except Federal informed of these regulations through otherwise indicated. This notice also Holidays. You may electronically access Local Notices to Mariners, press includes regulations that were not the public docket for this notice on the releases, and other means. Moreover, received in time to be included on the Internet at http://dms.dot.gov. actual notification is provided by Coast quarterly notice for the first quarter of FOR FURTHER INFORMATION CONTACT: For Guard patrol vessels enforcing the 2001. questions on this notice, contact restrictions imposed by the regulation. Christena Green, Office of Regulations Because Federal Register publication Dated: November 1, 2001. and Administrative Law, telephone was not possible before the beginning of S.G. Venckus, (202) 267–0133. For questions on the effective period, mariners were Chief, Office of Regulations and viewing, or on submitting material to personally notified of the contents of Administrative Law.
DISTRICT QUARTERLY REPORT
District docket Location Type Effective date
01–01–033 ...... Portland, ME ...... Safety Zone ...... 04/07/2001. 01–01–050 ...... Bath Iron Works, Portland, ME ...... Safety Zone ...... 04/11/2001. 01–01–072 ...... Port of New York/New Jersey Fleet Week ...... Security Zone ...... 05/23/2001. 01–01–073 ...... Fireworks Display, Newport, RI ...... Safety Zone ...... 06/29/2001. 01–01–080 ...... Boston, MA ...... Safety Zone ...... 04/09/2001. 01–01–086 ...... Kennebec River, Bath, ME ...... Safety Zone ...... 06/23/2001. 01–01–091 ...... Fireworks Display, Orleans, MA ...... Safety Zone ...... 06/30/2001. 01–01–094 ...... USS Monterey Port Visit, Boston, MA ...... Safety Zone ...... 06/08/2001. 01–01–097 ...... Mayflower II Port Visit, Boston, MA ...... Safety Zone ...... 06/24/2001. 01–01–106 ...... USS Klakring Port Visit, Gloucester, MA ...... Safety Zone ...... 06/28/2001. 01–01–109 ...... USS Wasp Port Visit, Boston, MA ...... Safety Zone ...... 06/29/2001. 05–01–010 ...... Mantoloking, NJ ...... Special Local ...... 05/20/2001. 05–01–012 ...... Patuxent River, Solomons, MD ...... Special Local ...... 05/27/2001. 05–01–014 ...... James River, VA ...... Safety Zone ...... 05/21/2001. 05–01–015 ...... Presidential Visit, Annapolis, MD ...... Security Zone ...... 05/25/2001. 05–01–016 ...... Ocean City, MD ...... Safety Zone ...... 06/18/2001. 05–01–017 ...... Hampton Roads, VA ...... Safety Zone ...... 06/14/2001. 05–01–024 ...... Delaware City, Delaware ...... Special Local ...... 06/16/2001. 05–01–025 ...... Delaware River, Camden, NJ ...... Special Local ...... 06/30/2001. 07–01–020 ...... San Juan Harbor, Puerto Rico ...... Special Local ...... 04/01/2001. 07–01–028 ...... Charleston Harbor, Charleston, SC ...... Special Local ...... 04/21/2001. 07–01–029 ...... Savannah River, Savannah, GA ...... Special Local ...... 05/21/2001. 07–01–032 ...... Miami Beach, FL ...... Special Local ...... 04/22/2001. 07–01–041 ...... Myrtle Beach, SC ...... Special Local ...... 06/01/2001. 07–01–044 ...... Hardeeville, SC ...... Special Local ...... 06/06/2001. 09–01–028 ...... Muskegon, Michigan ...... Safety Zone ...... 05/05/2001. 09–01–031 ...... Algoma Harbor, Algoma, WI ...... Safety Zone ...... 06/23/2001. 09–01–043 ...... Milwaukee, WI ...... Safety Zone ...... 06/02/2001. 09–01–056 ...... Pridefest 2001, Milwaukee Harbor, WI ...... Safety Zone ...... 06/08/2001.
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DISTRICT QUARTERLY REPORT—Continued
District docket Location Type Effective date
09–01–061 ...... Niagara River, Tonawanda, NY ...... Safety Zone ...... 06/23/2001. 09–01–068 ...... USS Silversides Filming, Lake Michigan ...... Safety Zone ...... 06/25/2001. 09–01–077 ...... Milwaukee Harbor, Milwaukee, WI ...... Safety Zone ...... 06/28/2001. 13–01–009 ...... Sub Ex-Narwhal, Puget Sound, WA ...... Safety Zone ...... 05/27/2001. 13–01–014 ...... Nana Provider, Swinomish Channel, WA ...... Safety Zone ...... 06/21/2001. 13–01–016 ...... Nana Provider, Swinomish Channel, WA ...... Safety Zone ...... 06/24/2001.
COTP QUARTERLY REPORT
COTP Docket Location Type Effective date
Charleston 01–126 ...... Charleston, SC ...... Safety Zone ...... 04/02/2001. Guam 01–005 ...... Agat Bay, Guam ...... Safety Zone ...... 05/06/2001. Guam 01–006 ...... North of Glass Breakwater, Guam ...... Safety Zone ...... 05/06/2001. Guam 01–007 ...... Agat Bay, Guam ...... Safety Zone ...... 05/08/2001. Guam 01–008 ...... North of Glass Breakwater, Guam ...... Safety Zone ...... 05/08/2001. Guam 01–009 ...... Cocos Lagoon, Guam ...... Safety Zone ...... 05/27/2001. Guam 01–011 ...... North of Glass Breakwater, Guam ...... Safety Zone ...... 06/08/2001. Houston/Galveston 01–007 ...... Gulf Intracoastal Waterway, M. 343 ...... Safety Zone ...... 06/04/2001. Jacksonville 01–038 ...... Fernandina Beach, FL ...... Safety Zone ...... 05/04/2001. Jacksonville 01–047 ...... Fernandina Beach, FL ...... Safety Zone ...... 05/28/2001. LA/LB 01–002 ...... Angels Gate, Los Angeles, CA ...... Safety Zone ...... 04/19/2001. LA/Long Beach 01–003 ...... Long Beach, CA ...... Safety Zone ...... 06/17/2001. Louisville 01–002 ...... Ohio River, M. 629 to 632 ...... Safety Zone ...... 05/23/2001. Louisville 01–003 ...... Riverbats Fireworks, Louisville, KY ...... Safety Zone ...... 05/27/2001. Louisville 01–007 ...... Aurora, Indiana ...... Safety Zone ...... 06/30/2001. Memphis 01–005 ...... Mississippi River, M. 532 to 528 ...... Safety Zone ...... 04/10/2001. Memphis 01–006 ...... Mississippi River, M. 7265.5 to 728.5 ...... Safety Zone ...... 04/14/2001. New Orleans 01–009 ...... Lwr Mississippi River ...... Safety Zone ...... 04/19/2001. New Orleans 01–019 ...... Ouachita River, M. 166 to 168 ...... Safety Zone ...... 06/30/2001. Paducah 01–001 ...... Upr Mississippi River, M. 0 to 1 ...... Safety Zone ...... 05/18/2001. Philadelphia 01–003 ...... Port of Wilmington, Wilmington, DE ...... Security Zone ...... 05/25/2001. Port Arthur 01–004 ...... Neches River, Beaumont, TX ...... Safety Zone ...... 04/01/2001. Port Arthur 01–005 ...... Port of Orange, Beaumont, TX ...... Safety Zone ...... 04/11/2001. Port Arthur 01–006 ...... Port of Orange/Port Arthur, TX ...... Safety Zone ...... 06/23/2001. Port Arthur 01–007 ...... Gulf Intracoastal Waterway, M. 290 ...... Safety Zone ...... 06/15/2001. San Diego 01–006 ...... San Clemente Island, CA ...... Security Zone ...... 04/18/2001. San Diego 01–011 ...... Colorado River ...... Safety Zone ...... 05/01/2001. San Diego 01–015 ...... Bio-Tech 2001 Conference ...... Safety Zone ...... 06/22/2001. San Francisco Bay 01–001 ...... San Francisco Bay, San Francisco, CA ...... Safety Zone ...... 04/02/2001. San Francisco Bay 01–002 ...... Suisun Bay, CA ...... Safety Zone ...... 04/21/2001. San Juan 01–025 ...... Guayanilla, Puerto Rico ...... Safety Zone ...... 04/05/2001. Savannah 01–051 ...... Beaufort, SC ...... Safety Zone ...... 06/04/2001. St. Louis 01–001 ...... Upper Mississippi River, M. 55.3 to 860 ...... Safety Zone ...... 04/14/2001. Tampa 01–030 ...... Tampa Bay, FL ...... Safety Zone ...... 04/19/2001. Tampa 01–031 ...... Tampa Bay, FL ...... Security Zone ...... 04/16/2001. Tampa 01–036 ...... Tampa Bay, FL ...... Security Zone ...... 04/27/2001.
REGULATIONS NOT ON PREVIOUS 1ST QUARTERLY REPORT
District/COTP Location Type Effective date
COTP Regulations Guam 01–003 ...... Outer Apra Harbor, Guam ...... Safety Zone ...... 03/13/01. Houston/Galveston 01–004 .. Houston, TX ...... Safety Zone ...... 03/21/01. New Orleans 01–008 ...... Lwr Mississippi River, M 108 to 110 ...... Safety Zone ...... 03/31/01. Port Arthur 01–003 ...... Port or Port Arthur/Orange, TX ...... Safety Zone ...... 02/18/01.
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[FR Doc. 01–27870 Filed 11–5–01; 8:45 am] DEPARTMENT OF COMMERCE the stocks and promote viable fisheries. BILLING CODE 4910–15–M The Convention Area is all waters of the National Oceanic and Atmospheric eastern Pacific Ocean between 40° N. Administration lat. and 40° S. lat. and east of 150° W. long. The boundary of the CYRA is FEDERAL COMMUNICATIONS 50 CFR Part 300 described at 50 CFR 300.21. COMMISSION [Docket No. 011005243–1243–01; I.D. At its annual meeting in June 2001, 102401B] the IATTC adopted a resolution (which 47 CFR Part 73 was subsequently agreed to by the DOS) International Fisheries Regulations; recommending that action be taken by [FCC 01–241, MM Docket No. 97–107, RM– Pacific Tuna Fisheries; Establishment member nations and other fishing 9023] of Incidental Catch Limit for Yellowfin nations to limit the catch of yellowfin Tuna Taken by the U.S. Purse Seine tuna in 2001 to 250,000 metric tons FM Broadcasting Services; Pottsville Fishery in the Eastern Pacific Ocean (mt), with the potential to increase the and Saltillo, MS quota by up to three increments of AGENCY: National Marine Fisheries AGENCY: 20,000 mt each (or a total quota of Federal Communications Service (NMFS), National Oceanic and 310,000 mt) if the Director of IATTC Commission. Atmospheric Administration (NOAA), concluded, based on catch and effort ACTION: Final rule; application for Commerce. review, denied. data, that the higher level of harvest ACTION: Fishing restrictions; request for would not pose a substantial danger of SUMMARY: In MM Docket No. 97–107, comments. overfishing to the stocks. the Commission denied an application SUMMARY: NMFS announces that the Under regulations at 50 CFR for review filed by Olvie E. Sisk, 2001 yellowfin tuna quota has been 300.29(a), the Regional Administrator is licensee of Station WCNA(FM), Channel reached and a 15-percent incidental authorized to notify tuna purse seine 240C3 (95.9 MHz), Potts Camp, catch limit is now in effect for yellowfin vessel owners and agents directly of any Mississippi. Sisk had requested review tuna taken in the U.S. purse seine quotas and associated regulatory of the Report and Order, 64 FR 38,592, fishery in the Commission’s Yellowfin measures that have been recommended published July 19, 1999, which the Regulatory Area (CYRA) of the Inter- by the IATTC and approved by the DOS. Commission denied because it found American Tropical Tuna Commission On September 12, 2001, the Regional that the staff had properly denied in the (IATTC) through the remainder of 2001. Administrator notified the vessel Report and Order Sisk’s petition for This action is taken in accordance with owners and agents of the 2001 yellowfin rulemaking (RM–9023) seeking the a resolution adopted by the IATTC and tuna quota and the incidental catch reallotment of Channel 240C3 from approved by the Department of State limit that would go into effect when the Potts Camp to Saltillo, Mississippi. The (DOS). quota was reached. NMFS also staff relied upon strong Commission announced the 2001 yellowfin tuna policy against removal of a community’s DATES: Effective 12:01 a.m., October 28, quota and incidental catch limit to the sole aural broadcast transmission 2001, through 11:59 p.m., December 31, public in the Federal Register at 66 FR service absent a compelling showing 2001. Comments will be accepted 53735, October 24, 2001. that a waiver of this prohibition is through November 21, 2001. Under regulations at 50 CFR warranted. Sisk’s allegations of his ADDRESSES: Submit comments to 300.29(b), when advised by the Director station’s financial peril fell well short of Rodney R. McInnis, Acting Regional of Investigations of the IATTC that a justifying such a waiver. With this Administrator, Southwest Region quota has been or is projected to be action, the proceeding is terminated. (Regional Administrator), NMFS, 501 reached, the Regional Administrator FOR FURTHER INFORMATION CONTACT: J. W. Ocean Boulevard, Suite 4200, Long may close the fishery and establish Bertron Withers, Jr., Mass Media Beach, CA 90802–4213. incidental catch allowances by direct Bureau, (202) 418–2180. FOR FURTHER INFORMATION CONTACT: notification to the owners or agents of Svein Fougner at 562–980–4040. SUPPLEMENTARY INFORMATION: This is a U.S. vessels who are fishing in or are summary of the Memorandum Opinion SUPPLEMENTARY INFORMATION: This eligible to fish in the Convention Area. and Order, MM Docket 97–107, adopted action is taken under the authority of As soon as practicable after being August 23, 2001, and released August the regulations at 50 CFR part 300, advised of the closure, NMFS will 29, 2001. The full text of this subpart C, which implement the Tuna publish the announcement in the Commission decision is available for Conventions Act (16 U.S.C. 955). The Federal Register. The Director of inspection and copying during normal United States is a member of the IATTC, Investigations of the IATTC advised the business hours in the Commission’s which was established under the Regional Administrator on October 11, Reference Information Center (room Convention for the Establishment of an 2001, that the 2001 quota, including all CY–A257), 445 12th Street, SW, Inter-American Tropical Tuna 3 incremental increases, was projected Washington, DC 20554. The complete Commission signed in 1949. The IATTC to be reached on October 27, 2001, and text of this decision may be also was established to provide an that incidental catch limits would be in purchased from the Commission’s copy international arrangement to ensure the effect for the rest of the year. contractor, Qualex International Portals effective international conservation and Accordingly, the incidental catch limit II, 445 12th Street, SW, Room CY–B402, management of tunas and tuna-like for yellowfin tuna taken in purse seine Washington, DC, 20554. fishes in the Convention Area. The gear will go into effect on October 28, IATTC maintains a scientific research 2001, and last through calendar year Federal Communications Commission. and fishery monitoring program and 2001. That is, from October 28, 2001, Magalie Roman Salas, annually assesses the status of stocks of through December 31, 2001, any Secretary. tuna and tuna fisheries to determine individual purse seiner when fishing for [FR Doc. 01–27781 Filed 11–5–01; 8:45 am] appropriate harvest limits or other other species of tuna may retain a BILLING CODE 6712–01–P measures to prevent overexploitation of maximum of 15–percent of yellowfin
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