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Federal Register / Vol. 65, No. 223 / Friday, November 17, 2000 / Rules and Regulations 69443 substance that is 3–4 order of magnitude be considered under the Regulatory Under the authority vested in the (1000 to 10,000 times) more potent than Flexibility Act (5 U.S.C. 601, et seq.). Attorney General by Section 201(d)(1) of but with a shorter duration of This action provides notification of the CSA [21 U.S.C. 811(d)(1)], and action. The effects of dihydroetorphine control of dihydroetorphine in Schedule delegated to the Administrator of the and its psychological dependence II of the CSA in order to comply with DEA by the Department of Justice liability are similar to those produced international treaty obligations. regulations (28 CFR 0.100) and by . Animal studies demonstrate Although dihydroetorphine was not redelegated to the Deputy Administrator that it is a highly potent with specifically listed in the CSA as a pursuant to 28 CFR 0.104, Appendix to effects that begin within 15 minutes of controlled substance, it was already Subpart R, Section 12, the Deputy administration and the effects last from controlled in Schedule II of the CSA as Administrator hereby amends 21 CFR 60–90 minutes. Dihydroetorphine was a derivative of . part 1308 as follows: registered in China in December of 1992 Unfunded Mandate Reform Act for the relief of acute severe pain. PART 1308Ð[AMENDED] However, abuse of dihydroetorphine This rule will not result in the began soon after it was marketed in expenditure of state, local and tribal 1. The authority citation for Part 1308 China in 1992. Dihydroetorphine is not governments, in the aggregate, or by the continues to read as follows: marketed or used medically in the private sector, of $100,000,000 or more Authority: 21 U.S.C. 811, 812, 871(b), United States. As a thebaine derivative, in any one year, and it will not unless otherwise noted. dihydroetorphine is controlled in significantly or uniquely affect small 2. Section 1308.12 is amended by Schedule II of the CSA in the United governments. Therefore, no actions were redesignating paragraphs (b)(1)(8) States. deemed necessary under provisions of through (b)(1)(16) as (b)(1)(9) through the Unfunded Mandates Reform Act of (b)(1)(17) and adding a new paragraph Under What Authority Is 1995. (b)(1)(8) to read as follows: Dihydroetorphine Controlled? Small Business Regulatory Enforcement This order is prompted by a letter § 1308.12 Schedule II. Fairness Act of 1996 dated November 11, 1998, in which the * * * * * United States Government was informed This rule is not a major rule as (b) * * * by the Secretary-General of the United defined by § 804 of the Small Business (1) * * * Nations that dihydroetorphine has been Regulatory Enforcement Fairness Act of (8) dihydroetorphine—9334 added to Schedule I of the Single 1996. This rule will not result in an * * * * * Convention on Drugs, 1961 annual effect on the economy of (1961 Convention). As a signatory $100,000,000 or more; a major increase Dated: November 7, 2000. Member State to the 1961 Convention, in costs or prices; or significant adverse Julio F. Mercado, the United States is obligated to control effects on competition, employment, Deputy Administrator. dihydroetorphine under national drug investment, productivity, innovation, or [FR Doc. 00–29439 Filed 11–16–00; 8:45 am] control legislation, i.e., the CSA. on the ability of the United States-based BILLING CODE 4410±09±M Dihydroetorphine is currently companies to compete with foreign- controlled under Schedule II of the CSA based companies in domestic and as a thebaine derivative, and as such, all export markets. regulations and criminal sanctions Executive Order 13132 Federalism DEPARTMENT OF TRANSPORTATION applicable to Schedule II substances have been and are applicable to This rule will not have substantial Coast Guard dihydroetorphine. Schedule II control direct effects on the states, on the under the CSA satisfies the relationship between the national 33 CFR Part 117 requirements of Schedule II control government and the states, or on the under the 1961 Convention. distribution of power and [CGD01±00±244] responsibilities among the various Executive Order 12866 levels of government. Therefore, in Drawbridge Operation Regulations: This regulation has been drafted and accordance with E.O. 13132, it is Raritan River, Arthur Kill, and Their reviewed in accordance with Executive determined that this rule will not have Tributaries, NJ Order 12866, Section 1(b), Principles of sufficient federalism implications to Regulation. DEA has determined that warrant the preparation of a Federalism AGENCY: Coast Guard, DOT. this rule is not a significant regulatory Assessment. ACTION: Notice of temporary deviation from regulations. action under Executive Order 12866, Plain English Section 3(f), Regulatory Planning and Review, and accordingly this rule has The DEA makes every effort to write SUMMARY: The Commander, First Coast not been reviewed by the Office of clearly. If you have suggestions as to Guard District, has issued a temporary Management and Budget. how to improve the clarity of this deviation from the drawbridge operation regulation please contact Patricia M. regulations for the Perth Amboy railroad Executive Order 12988—Civil Justice Good, Chief, Policy and Liaison Section, bridge, at mile 0.5, across the Raritan Reform Office of Diversion Control, Drug River in New Jersey. This deviation This regulation meets the applicable Enforcement Administration, from the regulations allows the owner of standards set forth in Sections 3(a) and Washington, DC 20537, phone (202) the bridge to keep the bridge in the 3(b)(2) of Executive Order 12988. 307–7297. closed position from 10:30 a.m. on November 28, 2000 through 11 a.m. on Regulatory Flexibility Act List of Subjects in 21 CFR Part 1308 November 30, 2000. This action is This action will not have a significant Administrative practice and necessary to facilitate the inspection of economic impact on a substantial procedure, Drug traffic control, the bridge wedge mechanism system at number of entities whose interests must , Prescription drugs. the bridge.

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DATES: This deviation is effective from downstream from the bridge location. downstream from the centerline of the November 28, 2000, through November The safety zone temporarily requires a Andrew McArdle Bridge. This safety 30, 2000. four-hour advance notification by zone prohibits entry into or movement FOR FURTHER INFORMATION CONTACT: Judy vessels wishing to transit through the within this portion of the Chelsea River Yee, Project Officer, First Coast Guard zone. The safety zone is needed to without a four hour advance notice District, at (212) 668–7165. protect vessels from the hazards posed given to personnel on scene. In an effort SUPPLEMENTARY INFORMATION: The Perth during repairs to the bascule floor to maximize commerce during the Amboy railroad bridge, at mile 0.5, beams and bridge fender system. It is closures, waterway users were invited to across the Raritan River has a vertical also needed to allow sufficient time to provide input at meetings on the clearance in the closed position of 8 feet move the construction barges in and out following dates: August 11, 17, 24, and at mean high water and 13 feet at mean of the channel for vessel transits during 31, September 7, 14, 21, and 28, and low water. The existing drawbridge the repair period. October 5, 2000. The meetings, hosted operating regulations are listed at 33 DATES: This rule is effective from by Marine Safety Office Boston, were CFR 117.747. Wednesday, October 18, 2000, through attended by stakeholders and promoted The bridge owner, New Jersey Transit Friday, December 8, 2000. a consensus of the most favorable requirements for bridge repair efforts (NJTRANSIT), requested a temporary ADDRESSES: Documents as indicated in deviation from the drawbridge operating this preamble are part of docket CGD1– during the effective period. The repair work requires a four hour regulations to facilitate the inspection of 00–240 and are available for inspection advance notice for passage to minimize the bridge wedge mechanism system at or copying at Marine Safety Office the bridge. This deviation to the lost work time due to setting up, Boston, 455 Commercial Street, Boston, cleaning the site, and assuring safety for operating regulations allows MA between the hours of 8 a.m. and 3 NJTRANSIT to keep the Perth Amboy ship traffic. The Coast Guard was able p.m., Monday through Friday, except to balance this need with community Bridge in the closed position from 10:30 Federal holidays. demands through the aforementioned a.m. on November 28, 2000 through 11 FOR FURTHER INFORMATION CONTACT: open forum. The group arrived at a a.m. on November 30, 2000. Lieutenant (Junior Grade) David Sherry, consensus between marine operators, The bridge owner did not provide the Waterways Management Division, Coast required thirty-day notice to the Coast the bridge owner, Massachusetts State Guard Marine Safety Office Boston, Highway officials, and construction Guard for this deviation; however, this (617) 223–3000. deviation was approved because the contractor. The expected duration of the SUPPLEMENTARY INFORMATION: inspection/repairs are necessary in safety zone will be from Wednesday, order to keep the bridge operating and Regulatory Information October 18, 2000 through Friday, December 8, 2000. During the effective prevent an unscheduled closure due to Pursuant to 5 U.S.C 553, a notice of dates, the channel will be open with component failure. proposed rulemaking (NPRM) was not construction on going, but a four-hour In accordance with 33 CFR 117.35(c), published for this regulation. Good this work will be performed with all due notice is required for vessel passage. cause exists for not publishing a NPRM Notice shall be given to the Andrew speed in order to return the bridge to and for making this regulation effective normal operation as soon as possible. McCardle Bridge bridge tender via VHF in less than 30 days after Federal channel 13. The bridge tender will This deviation from the operating Register publication. Conclusive regulations is authorized under 33 CFR convey the notice of passage to the information about this event was not construction barge operator. Smaller 117.35. provided to the Coast Guard until vessels that can navigate the area Dated: November 7, 2000. October 12, 2000, making it impossible without requiring the barges to move are Gerald M. Davis, to publish a NPRM or a final rule 30 not required to give this notice. The Captain, U.S. Coast Guard, Acting days in advance of its effective date. Coast Guard will make Marine Safety Commander, First Coast Guard District. Any delay encountered in this Information Broadcasts and Local [FR Doc. 00–29516 Filed 11–16–00; 8:45 am] regulation’s effective date would be Notice to Mariners announcements BILLING CODE 4910±15±U unnecessary and contrary to public informing mariners of this safety zone. interest since immediate action is Regulatory Evaluation needed to regulate a portion of the DEPARTMENT OF TRANSPORTATION Chelsea River and protect the maritime This final rule is not a significant public from the hazards associated with regulatory action under section 3(f) of Coast Guard bridge repair activities. Additionally, Executive Order 12866 and does not the repair activity takes place only on require an assessment of potential costs 33 CFR Part 165 weekdays from 6:30 a.m. until 5 p.m. and benefits under section 6(a)(3) of that [CGD1±00±240] and does not close the channel to users. Order. The Office of Management and Budget has not reviewed it under that RIN 2115±AA97 Background and Purpose Order. It is not significant under the The Andrew McArdle Bridge over the regulatory policies and procedures of Safety Zone: Andrew McArdle Chelsea River, Chelsea, MA, fender the Department of Transportation (DOT) (Meridian Street) Bridge, Chelsea system and bascule floor beams require (44 FR 11040; February 26, 1979). The River, Chelsea, MA repairs. During the repair evolution, Coast Guard expects the economic AGENCY: Coast Guard, DOT. barges will be moored in the center of impact of this rule to be so minimal that ACTION: Temporary final rule. the channel. Barge placement requires a a full regulatory evaluation under four-hour advance notice by vessels paragraph 10e of the regulatory policies SUMMARY: The Coast Guard is wishing to transit the area, to ensure and procedures of DOT is unnecessary. establishing a temporary safety zone on vessel safety. This finding is based on the limited the Chelsea River for the Andrew This regulation establishes a safety duration of the safety zone and limited McArdle Bridge repairs in all waters 100 zone in all waters of the Chelsea River commercial traffic expected in the area yards upstream and 100 yards 100 yards upstream and 100 yards during the effective periods. Moreover,

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