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Federal Register/Vol. 79, No. 39/Thursday, February 27, 2014/Rules and Regulations Federal Register / Vol. 79, No. 39 / Thursday, February 27, 2014 / Rules and Regulations 10985 (2) Turkeys— Combination in Zoalene in grams/ton grams per ton Indications for use Limitations Sponsor (i) 113.5 to 170.3 ..... ................................. Growing turkeys: For prevention and con- Feed continuously as sole ration. For tur- 054771 trol of coccidiosis. keys grown for meat purposes only. Do not feed to laying birds. (ii) 113.5 to 170.3 .... Bacitracin methylene Growing turkeys: For prevention and con- Feed continuously as sole ration until 14 054771 disalicylate 4 to 50. trol of coccidiosis; and for increased to 16 weeks of age. For turkeys grown rate of weight gain and improved feed for meat purposes only. Do not feed to efficiency. laying birds. Dated: February 3, 2014. Legal Authority initiated by the Attorney General (1) on Bernadette Dunham, The DEA implements and enforces his own motion; (2) at the request of the Director, Center for Veterinary Medicine. titles II and III of the Comprehensive Secretary of the Department of Health 1 [FR Doc. 2014–02617 Filed 2–26–14; 8:45 am] Drug Abuse Prevention and Control Act and Human Services (HHS), or (3) on the petition of any interested party. 21 BILLING CODE 4160–01–P of 1970, as amended. Titles II and III are referred to as the ‘‘Controlled U.S.C. 811(a). This action is based on a Substances Act’’ and the ‘‘Controlled recommendation from the Assistant DEPARTMENT OF JUSTICE Substances Import and Export Act,’’ Secretary of the HHS and on an respectively, and are collectively evaluation of all other relevant data by Drug Enforcement Administration referred to as the ‘‘Controlled the DEA. This action imposes the Substances Act’’ or the ‘‘CSA’’ for the regulatory controls and administrative, 21 CFR Part 1308 purpose of this action. 21 U.S.C. 801– civil, and criminal sanctions applicable 971. The DEA publishes the to schedule IV controlled substances on [Docket No. DEA–370] implementing regulations for these persons who handle or propose to handle alfaxalone. statutes in title 21 of the Code of Federal Schedules of Controlled Substances: Regulations (CFR), parts 1300 to 1321. Background Placement of Alfaxalone into Schedule The CSA and its implementing IV Alfaxalone (5a-pregnan-3a-ol-11,20- regulations are designed to prevent, dione, previously spelled detect, and eliminate the diversion of ‘‘alphaxalone’’), a substance with AGENCY: Drug Enforcement controlled substances and listed Administration, Department of Justice. central nervous system (CNS) chemicals into the illicit market while depressant properties, is a neurosteroid ACTION: Final rule. providing for the legitimate medical, that is a derivative of 11-alpha-hydroxy- scientific, research, and industrial needs progesterone. On October 23, 2012, the SUMMARY: With the issuance of this final of the United States. Controlled Food and Drug Administration (FDA) rule, the Administrator of the Drug substances have the potential for abuse published a final rule to approve a New Enforcement Administration (DEA) and dependence and are controlled to Animal Drug Application (NADA, 141– places the substance 5a-pregnan-3a-ol- protect the public health and safety. 342) for alfaxalone (Alfaxan®), as an 11,20-dione (alfaxalone), including its Under the CSA, controlled substances intravenous injectable anesthetic, for the salts, isomers, and salts of isomers, into are classified into one of five schedules induction and maintenance of schedule IV of the Controlled based upon their potential for abuse, anesthesia and for induction of Substances Act (CSA). This scheduling their currently accepted medical use, anesthesia followed by maintenance of action is pursuant to the CSA which and the degree of dependence the anesthesia with an inhalant anesthetic, requires that such actions be made on substance may cause. 21 U.S.C. 812. The in cats and dogs (77 FR 64715). the record after opportunity for a initial schedules of controlled Alfaxalone primarily acts as an agonist hearing through formal rulemaking. substances established by Congress are at the gamma-aminobutyric acid This action imposes the regulatory found at 21 U.S.C. 812(c), and the (GABA) receptor-channel complex, with controls and administrative, civil, and current list of all scheduled substances a mechanism of action at this site criminal sanctions applicable to is published at 21 CFR part 1308. similar to that of barbiturates like schedule IV controlled substances on Pursuant to 21 U.S.C. 811(a)(1), the phenobarbital (schedule IV) and persons who handle (manufacture, Attorney General may, by rule, ‘‘add to methohexital (schedule IV), distribute, dispense, import, export, such a schedule or transfer between benzodiazepines such as diazepam engage in research, conduct such schedules any drug or other (schedule IV) and midazolam (schedule instructional activities with, or possess) substance if he (A) finds that such drug IV), as well as the anesthetic agents or propose to handle alfaxalone and or other substance has a potential for substances containing alfaxalone. abuse, and (B) makes with respect to 1 As set forth in a memorandum of understanding such drug or other substance the entered into by the HHS, the Food and Drug DATES: Effective Date: March 31, 2014. findings prescribed by [21 U.S.C. 812(b)] Administration (FDA), and the National Institute on for the schedule in which such drug is Drug Abuse (NIDA), the FDA acts as the lead agency FOR FURTHER INFORMATION CONTACT: within the HHS in carrying out the Secretary’s Ruth A. Carter, Office of Diversion to be placed . ..’’ Pursuant to 28 CFR scheduling responsibilities under the CSA, with the Control, Drug Enforcement 0.100(b), the Attorney General has concurrence of NIDA. 50 FR 9518, Mar. 8, 1995. In Administration; Mailing Address: 8701 delegated this scheduling authority to addition, because the Secretary of the HHS has the Administrator of the DEA. 28 CFR delegated to the Assistant Secretary for Health of Morrissette Drive, Springfield, Virginia the HHS the authority to make domestic drug 22152; Telephone: (202) 598–6812. 0.104. scheduling recommendations, for purposes of this The CSA provides that scheduling of document, all subsequent references to ‘‘Secretary’’ SUPPLEMENTARY INFORMATION: any drug or other substance may be have been replaced with ‘‘Assistant Secretary.’’ VerDate Mar<15>2010 16:18 Feb 26, 2014 Jkt 232001 PO 00000 Frm 00035 Fmt 4700 Sfmt 4700 E:\FR\FM\27FER1.SGM 27FER1 TKELLEY on DSK3SPTVN1PROD with RULES 10986 Federal Register / Vol. 79, No. 39 / Thursday, February 27, 2014 / Rules and Regulations propofol (proposed to be controlled as a indicated support for controlling and significant of abuse; (6) what, if any, schedule IV substance, 75 FR 66195, alfaxalone under the CSA based on the risk there is to the public health; (7) its Oct. 27, 2010) and fospropofol (schedule abuse potential of the substance. psychic or physiological dependence IV). Because alfaxalone is indicated for use liability; and (8) whether the substance as a pre-anesthetic and anesthetic in is an immediate precursor of a HHS and DEA Eight-Factor Analyses cats and dogs, these commenters felt substance already controlled. The On July 17, 2012, the Assistant that the abuse potential was particularly summary of each factor as analyzed by Secretary of the HHS provided to the high for persons with access to the the HHS and the DEA, and as DEA a scientific and medical evaluation substance in the medical field. One considered by the DEA in this and scheduling recommendation commenter noted that controlling scheduling action, was provided in the entitled ‘‘Basis for the Recommendation alfaxalone as a schedule IV controlled proposed rule. Both the DEA and the to Control Alfaxalone in Schedule IV of substance is appropriate because it HHS analyses have been made available the Controlled Substances Act.’’ After could be abused in a manner similar to in their entirety under ‘‘Supporting and considering the eight factors in 21 other schedule IV CNS depressants. The Related Material’’ of the public docket U.S.C. 811(c), including consideration commenters believe that controlling for this rule at www.regulations.gov of the substance’s abuse potential, alfaxalone as a schedule IV controlled under Docket Number DEA–370. legitimate medical use, and dependence substance will provide the necessary Based on the review of the HHS liability, the Assistant Secretary of the controls to prevent its diversion. evaluation and scheduling HHS recommended that alfaxalone be DEA Response: The DEA appreciates recommendation and all other relevant controlled in schedule IV of the CSA the comments in support of this data, the DEA found that alfaxalone has under 21 U.S.C. 812(b). In response, the rulemaking. an abuse potential similar to other DEA conducted its own eight-factor Opposition to the Proposed Rule: schedule IV drugs, including the analysis of alfaxalone pursuant to 21 Two commenters opposed the benzodiazepines diazepam and U.S.C. 811(c). Both the DEA and HHS proposal to control alfaxalone as a midazolam, the barbiturates analyses are available in their entirety in schedule IV controlled substance. phenobarbital and methohexital, and the public docket for this rule (Docket Request Not to Control Alfaxalone: also the anesthetic agents propofol Number DEA–370) at One commenter opposed controlling (proposed to be controlled as a schedule www.regulations.gov under ‘‘Supporting alfaxalone at all and stated that IV substance, 75 FR 66195, Oct. 27, and Related
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