Federal Register / Vol. 70, No. 145 / Friday, July 29, 2005 / Proposed Rules 43809

Approximately 251 companies 9th Street, NW., Washington, DC. DEPARTMENT OF JUSTICE (primarily importers) are currently Arrangements to inspect submitted serviced by the airport. comments should be made in advance Drug Enforcement Administration CBP facilities are already in place at by calling Mr. Joseph Clark at (202) 572– the Tri-Cities Regional User Fee Airport. 8768. Comments may also be accessed 21 CFR Part 1308 CBP believes that the establishment of on the EPA Partner EDOCKET Web site this port will provide significant or Federal eRulemaking Portal. For [Docket No. DEA–269P] benefits to the local community, further additional information on accessing enhancing the economic growth that is comments via the EPA Partner Schedules of Controlled Substances: Placement of Embutramide Into already being experienced in this area, EDOCKET Web Site or Federal by providing enhanced business Schedule III eRulemaking Portal, see the ADDRESSES competitiveness for existing enterprises section of this document. and enabling the retention and AGENCY: Drug Enforcement expansion of the number of jobs in the Authority Administration, Department of Justice. area. ACTION: Notice of proposed rulemaking. The Tri-Cities Regional Airport is This change is proposed under the committed to continue making the authority of 5 U.S.C. 301 and 19 U.S.C. SUMMARY: This proposed rule is issued optimal use of electronic data transfer 2, 66, and 1624. by the Deputy Administrator of the Drug capability to permit integration with the Enforcement Administration (DEA) to CBP Automated Commercial System for The Regulatory Flexibility Act and place the substance embutramide, processing entries. This commitment is Executive Order 12866 including its salts, into Schedule III of shown in the current financial support, the Controlled Substances Act (CSA). With DHS approval, CBP establishes, This proposed action is based on a furnished by the Tri-Cities Airport expands and consolidates CBP ports of Commission, of an interstate dedicated recommendation from the Acting entry throughout the United States to Assistant Secretary for Health of the data line and computer upgrades. Since accommodate the volume of CBP-related October 1, 2003, two companies, each Department of Health and Human activity in various parts of the country. with the automated capacity to interface Services (DHHS) and on an evaluation The Office of Management and Budget with CBP, have occupied established of the relevant data by DEA. If finalized, offices in the Tri-Cities Airport. has determined that this regulatory this action will impose the regulatory action is not significant within the controls and criminal sanctions Description of Proposed Port-of-Entry meaning of Executive Order 12866. This applicable to Schedule III on those who Limits proposed rule also will not have a handle embutramide and products The geographical limits of the significant economic impact on a containing embutramide. proposed Tri-Cities, TN/VA, port of substantial number of small entities. DATES: Written comments must be entry would be as follows: Accordingly, it is certified that this postmarked, and electronic comments The contiguous outer boundaries of document is not subject to the must be sent, on or before August 29, Sullivan County, Tennessee; additional requirements of the 2005. Washington County, Tennessee; and provisions of the Regulatory Flexibility Washington County, Virginia. ADDRESSES: To ensure proper handling Act (5 U.S.C. 601 et seq.). of comments, please reference ‘‘Docket Proposed Amendments to Regulations Signing Authority No. DEA–269P’’ on all written and If the proposed port of entry electronic correspondence. Written designation is adopted, the list of CBP The signing authority for this comments being sent via regular mail ports of entry at 19 CFR 101.3(b)(1) will document falls under 19 CFR 0.2(a) should be sent to the Deputy be amended to add Tri-Cities, TN/VA, because the establishment of a new port- Administrator, Drug Enforcement as a port of entry in Tennessee, and of-entry and the termination of the user- Administration, Washington, DC 20537, ‘‘Tri-City Regional Airport’’ will be fee status of an airport are not within Attention: DEA Federal Register deleted from the list of user-fee airports the bounds of those regulations for Representative/ODL. Written comments at 19 CFR 122.15(b). Note that the which the Secretary of the Treasury has sent via express mail should be sent to regulations currently refer to the airport retained sole authority. Accordingly, the Deputy Administrator, Drug as ‘‘Tri-City’’ rather than the correct this notice of proposed rulemaking may Enforcement Administration, Attention: ‘‘Tri-Cities.’’ be signed by the Secretary of Homeland DEA Federal Register Representative/ Security (or his or her delegate). ODL, 2401 Jefferson-Davis Highway, Comments Alexandria, VA 22301. Comments may Before adopting this proposal, Dated: July 25, 2005. be directly sent to DEA electronically by consideration will be given to any Michael Chertoff, sending an electronic message to written comments that are timely Secretary. [email protected]. submitted to CBP. All such comments [FR Doc. 05–15045 Filed 7–28–05; 8:45 am] Comments may also be sent received from the public pursuant to BILLING CODE 4820–02–P electronically through http:// this notice of proposed rulemaking will www.regulations.gov using the be available for public inspection in electronic comment form provided on accordance with the Freedom of that site. An electronic copy of this Information Act (5 U.S.C. 552) and 19 document is also available at the CFR 103.11(b), during regular business http://www.regulations.gov Web site. days between the hours of 9 a.m. and DEA will accept electronic comments 4:30 p.m. at the Regulations Branch, containing MS Word, WordPerfect, Office of Regulations and Rulings, Adobe PDF, or Excel file formats only. Customs and Border Protection, DEA will not accept any file format Department of Homeland Security, 799 other than those specifically listed here.

VerDate jul<14>2003 17:15 Jul 28, 2005 Jkt 205001 PO 00000 Frm 00024 Fmt 4702 Sfmt 4702 E:\FR\FM\29JYP1.SGM 29JYP1 43810 Federal Register / Vol. 70, No. 145 / Friday, July 29, 2005 / Proposed Rules

FOR FURTHER INFORMATION CONTACT: The pharmacological data suggest that (3) Abuse of embutramide may lead to Christine Sannerud, Ph.D., Chief, Drug the abuse potential of embutramide may moderate or low physical dependence and Chemical Evaluation Section, Drug be similar to that of CNS depressants or high psychological dependence. Enforcement Administration, such as barbiturates and their products Based on these findings, the Deputy Washington, DC 20537, (202) 307–7183. (Schedules II through IV) and GHB and Administrator of DEA concludes that SUPPLEMENTARY INFORMATION: its product (Schedules I and III) that are embutramide warrants control in controlled under the CSA. Case reports Schedule III of the CSA. Note Regarding This Scheduling Action of suicides, attempted suicides, and Interested persons are invited to In accordance with the provisions of accidental exposures involving submit their comments, objections or the Controlled Substances Act (21 embutramide containing products have requests for a hearing with regard to this U.S.C. 811(a)), this action is a formal been published in the scientific proposal. Requests for a hearing should rulemaking ‘‘on the record after literature. Embutramide is not currently state, with particularity, the issues opportunity for a hearing.’’ Such marketed in the United States. From concerning which the person desires to be heard. All correspondence regarding proceedings are conducted pursuant to 1998 to 2004, there were no law this matter should be submitted to the the provisions of the Administrative enforcement encounters of embutramide Deputy Administrator, Drug Procedure Act (5 U.S.C. 556 and 557). including seizures or cases. Enforcement Administration, Interested persons are invited to submit On January 26, 2005, the Acting Washington, DC 20537, Attention: DEA their comments, objections or requests Assistant Secretary for Health, DHHS, Federal Register Representative/ODL. In for a hearing with regard to this sent the Deputy Administrator of DEA a the event that comments, objections, or proposal. Requests for a hearing should scientific and medical evaluation and a requests for a hearing raise one or more be filed in accordance with 21 CFR letter recommending that embutramide issues which the Deputy Administrator 1308.44 and should state, with be placed into Schedule III of the CSA. finds warrant a hearing, the Deputy particularity, the issues concerning Enclosed with the January 26, 2005, Administrator shall order a public which the person desires to be heard. letter was a document prepared by the hearing by notice in the Federal All correspondence regarding this FDA entitled, ‘‘Basis for the Register, summarizing the issues to be matter should be submitted to the Drug Recommendation to Control heard and setting the time for the Enforcement Administration using the Embutramide in Schedule III of the hearing. address information provided above. Controlled Substances Act (CSA).’’ The document contained a review of the Requirements for Handling Background factors which the CSA requires the Embutramide Embutramide is a central nervous Secretary to consider (21 U.S.C. 811(b)). The factors considered by the Acting If this rule is finalized as proposed, system depressant drug. On May 20, embutramide would be subject to 2005, the Food and Drug Administration Assistant Secretary of Health and DEA with respect to embutramide were: Controlled Substances Act and (FDA) approved a New Animal Drug Controlled Substances Import and Application (NADA) that provides for (1) Its actual or relative potential for abuse; Export Act regulatory controls and veterinary prescription use of administrative, civil and criminal TM (2) Scientific evidence of its Tributame Euthanasia Solution sanctions applicable to the manufacture, containing embutramide, chloroquine pharmacological effects; (3) The state of current scientific distribution, dispensing, importing and phosphate, and lidocaine by exporting of a Schedule III controlled intravenous injection for euthanasia of knowledge regarding the drug; (4) Its history and current pattern of substance, including the following: dogs (70 FR 36336). Embutramide as abuse; Registration. Any person who one of the ingredients in the veterinary (5) The scope, duration, and manufactures, distributes, dispenses, euthanasia drug product, T–61, was significance of abuse; imports, exports, engages in research or previously marketed in the United (6) What, if any, risk there is to the conducts instructional activities with States. T–61 was withdrawn from the public health; embutramide, or who desires to market in 1991. (7) Its psychic or physiological manufacture, distribute, dispense, Embutramide is a derivative of dependence liability; and import, export, engage in instructional gamma-hydroxybutyric acid (GHB). Its (8) Whether the substance is an activities or conduct research with chemical name is N-[2-(m- immediate precursor of a substance embutramide, would need to be methoxyphenyl)-2-ethyl-butyl]-gamma- already controlled under this registered to conduct such activities in hydroxybutyramide (CAS number subchapter. (21 U.S.C. 811(c)) accordance with Part 1301 of Title 21 of 15687–14–6). Embutramide shares Based on the recommendation of the the Code of Federal Regulations. pharmacological similarities with other Acting Assistant Secretary for Health, Security. Embutramide would be central nervous system (CNS) received in accordance with section subject to Schedule III-V security depressants such as barbiturates, GHB 201(b) of the Act (21 U.S.C. 811(b)), and requirements and must be and ketamine. It produces a reversible the independent review of the available manufactured, distributed and stored in stupor-like state (narcosis) in data by DEA, the Deputy Administrator accordance with §§ 1301.71, 1301.72(b), experimental animals. of DEA, pursuant to sections 201(a) and (c), and (d), 1301.73, 1301.74, The effects of embutramide on 201(b) of the Act (21 U.S.C. 811(a) and 1301.75(b) and (c), 1301.76, and 1301.77 locomotor activity, rearing, forelimb 811(b)), finds that: of Title 21 of the Code of Federal grip strength, hind-limb splay, and the (1) Based on information now Regulations. performance of inverted screen tests on available, embutramide has a low Labeling and Packaging. All labels rodents were similar to those of potential for abuse relative to the drugs and labeling for commercial containers pentobarbital. Embutramide produces or other substances in Schedules I and of embutramide which are distributed complete substitution for the II; after finalization of this rule would need pentobarbital discriminative stimulus in (2) Embutramide has a currently to comply with requirements of mice. Methohexital-trained rhesus accepted medical use in treatment in the §§ 1302.03–1302.07 of Title 21 of the monkeys self-administer embutramide. United States; and Code of Federal Regulations.

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Inventory. Every registrant required to Executive Order 12988 2. Section 1308.13 is proposed to be keep records and who possesses any This regulation meets the applicable amended by redesignating paragraphs quantity of embutramide would be standards set forth in Sections 3(a) and (c)(5) through (c)(13) as paragraphs required to keep an inventory of all 3(b)(2) of Executive Order 12988 Civil (c)(6) through (c)(14), and adding a new stocks of embutramide on hand Justice Reform. paragraph (c)(5) to read as follows: pursuant to §§ 1304.03, 1304.04 and 1304.11 of Title 21 of the Code of Executive Order 13132 § 1308.13 Schedule III. Federal Regulations. Every registrant This rulemaking does not preempt or * * * * * who desires registration in Schedule III modify any provision of state law; nor (c) * * * for embutramide would be required to does it impose enforcement conduct an inventory of all stocks of the responsibilities on any state; nor does it (5) Embutramide ...... XXXX substance on hand at the time of diminish the power of any state to * * * * * registration. enforce its own laws. Accordingly, this Records. All registrants would be Dated: July 22, 2005. rulemaking does not have federalism Michele M. Leonhart, required to keep records pursuant to implications warranting the application Deputy Administrator. §§ 1304.03, 1304.04, 1304.21, 1304.22, of Executive Order 13132. and 1304.23 of Title 21 of the Code of [FR Doc. 05–15035 Filed 7–28–05; 8:45 am] Federal Regulations. Unfunded Mandates Reform Act of 1995 BILLING CODE 4410–09–P Prescriptions. All prescriptions for This rule will not result in the embutramide or prescriptions for expenditure by State, local and tribal products containing embutramide governments, in the aggregate, or by the DEPARTMENT OF THE TREASURY would be required to be issued pursuant private sector, of $115,000,000 or more to 21 CFR 1306.03–1306.06 and in any one year, and will not Internal Revenue Service 1306.21–1306.27. All prescriptions for significantly or uniquely affect small embutramide or products containing governments. Therefore, no actions were 26 CFR Part 1 embutramide issued after publication of deemed necessary under provisions of [REG–149436–04] the Final Rule, if authorized for the Unfunded Mandates Reform Act of refilling, would be limited to five refills. 1995. RIN 1545–BD92 Importation and Exportation. All importation and exportation of Small Business Regulatory Enforcement Return Required by Subchapter T embutramide would need to be in Fairness Act of 1996 Cooperatives Under Section 6012 compliance with part 1312 of Title 21 of This rule is not a major rule as AGENCY: Internal Revenue Service (IRS), the Code of Federal Regulations. defined by section 804 of the Small Treasury. Criminal Liability. Any activity with Business Regulatory Enforcement ACTION: Notice of proposed rulemaking. embutramide not authorized by, or in Fairness Act of 1996. This rule will not violation of, the Controlled Substances result in an annual effect on the SUMMARY: This document contains Act or the Controlled Substances Import economy of $100,000,000 or more; a proposed regulations that prescribe the and Export Act occurring on or after major increase in costs or prices: or form that cooperatives must use to file finalization of this proposed rule would significant adverse effects on their income tax returns. The be unlawful. competition, employment, investment, regulations affect all cooperatives that Regulatory Certifications productivity, innovation, or on the are currently required to file an income ability of United States-based tax return on either Form 1120, ‘‘U.S. Executive Order 12866 companies to compete with foreign- Corporation Income Tax Return,’’ or In accordance with the provisions of based companies in domestic and Form 990–C, ‘‘Farmers’’ Cooperative the CSA (21 U.S.C. 811(a)), this action export markets. Association Income Tax Return.’’ is a formal rulemaking ‘‘on the record List of Subjects in 21 CFR Part 1308 DATES: Written or electronic comments after opportunity for a hearing.’’ Such and requests for a public hearing must proceedings are conducted pursuant to Administrative practice and be received by October 27, 2005. the provisions of 5 U.S.C. 556 and 557 procedure, Drug traffic control, ADDRESSES: Send submissions to: and, as such, are exempt from review by Narcotics, Prescription drugs. CC:PA:LPD:PR (REG–149436–04), room the Office of Management and Budget Under the authority vested in the 5203, Internal Revenue Service, POB pursuant to Executive Order 12866, Attorney General by section 201(a) of 7604, Ben Franklin Station, Washington, section 3(d)(1). the CSA (21 U.S.C. 811(a)), and DC 20044. Submissions may be hand Regulatory Flexibility Act delegated to the Administrator of DEA delivered Monday through Friday by Department of Justice regulations (28 between the hours of 8 a.m. and 4 p.m. The Deputy Administrator, in CFR 0.100), and redelegated to the accordance with the Regulatory to: CC:PA:LPD:PR (REG–149436–04), Deputy Administrator pursuant to 28 Courier’s Desk, Internal Revenue Flexibility Act (5 U.S.C. 605(b)), has CFR 0.104, the Deputy Administrator reviewed this proposed rule and by Service, 1111 Constitution Avenue, hereby proposes that 21 CFR part 1308 NW., Washington, DC, or sent approving it certifies that it will not be amended as follows: have a significant economic impact on electronically, via the IRS Internet site a substantial number of small entities. PART 1308—SCHEDULES OF at http://www.irs.gov/regs, or via the Embutramide products will be CONTROLLED SUBSTANCES Federal eRulemaking Portal at http:// prescription drugs used for the [AMENDED] www.regulations.gov (IRS–REG– euthanasia of animals. Handlers of 149436–04). A public hearing may be embutramide also handle other 1. The authority citation for Part 1308 scheduled if requested by any person controlled substances used to euthanize continues to read as follows: who timely submits comments. animals which are already subject to the Authority: 21 U.S.C. 811, 812, 871(b), FOR FURTHER INFORMATION CONTACT: regulatory requirements of the CSA. unless otherwise noted. Concerning the proposed regulations,

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