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 . 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 ACTION: Final rule. providing for the legitimate medical, that is a derivative of 11-alpha-hydroxy- scientific, research, and industrial needs . 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 , 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 like schedule IV controlled substances on Pursuant to 21 U.S.C. 811(a)(1), the (schedule IV) and persons who handle (manufacture, Attorney General may, by rule, ‘‘add to (schedule IV), distribute, dispense, import, export, such a schedule or transfer between such as engage in research, conduct such schedules any drug or other (schedule IV) and (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.’’

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(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 Material.’’ alfaxalone does not have the same abuse 2010) and fospropofol. Alfaxalone also potential as Xanax® () ® acts as an agonist at the gamma- Determination to Schedule Alfaxalone (schedule IV), Valium (diazepam) aminobutyric acid (GABA) receptor- After a review of the available data, (schedule IV), and other channel complex, with a mechanism of including the scientific and medical benzodiazepines. The commenter also action at the site similar to that of evaluation and the scheduling stated that controlling alfaxalone under benzodiazepines like recommendation from the HHS, the the CSA would make it difficult for diazepam(schedule IV) and midazolam Administrator of the DEA published in veterinarians and animal surgeons to (schedule IV). This mechanism of action the Federal Register a notice of acquire the drug. Lastly, this commenter is also similar to that of other schedule proposed rulemaking (NPRM) entitled stated that alfaxalone is ‘‘unheard of IV controlled substances, including ‘‘Schedules of Controlled Substances: outside of the veterinary community barbiturates like phenobarbital and Placement of Alfaxalone into Schedule and does not have a ‘black market’ as do methohexital, and also anesthetic agents IV’’ which proposed placement of the other schedule IV drugs.’’ like propofol (proposed to be controlled alfaxalone in schedule IV of the CSA. 78 DEA Response: The DEA does not as a schedule IV substance, 75 FR FR 17895, March 25, 2013. The agree. Pursuant to 21 U.S.C. 811(a)(1), 66195, Oct. 27, 2010) and fospropofol. It proposed rule provided an opportunity the Attorney General may, by rule, ‘‘add should be noted that alfaxalone’s for interested persons to file a request to such a schedule or transfer between current exclusive use as a veterinary for hearing in accordance with DEA such schedules any drug or other anesthetic drug and the asserted regulations by April 24, 2013. No substance if he (A) finds that such drug conclusion that there is no ‘‘black requests for such a hearing were or other substance has a potential for market’’ for the substance, do not negate received by the DEA. The NPRM also abuse, and (B) makes with respect to its abuse potential and associated risk of provided an opportunity for interested such drug or other substance the diversion. The DEA and HHS analyses persons to submit written comments on findings prescribed by [21 U.S.C. 812(b)] demonstrate that alfaxalone does have the proposal on or before April 24, 2013. for the schedule in which such drug is the potential for abuse and meets the to be placed * * *.’’ This scheduling necessary findings on potential for Comments Received action was initiated when the DEA abuse, currently accepted medical use, The DEA received four comments on received a scientific and medical and physical or psychological the proposed rule to schedule evaluation and a scheduling dependence for placement in schedule alfaxalone. Two commenters were in recommendation to control alfaxalone IV. favor of controlling alfaxalone as a as a schedule IV controlled substance Burdens associated with acquiring a schedule IV controlled substance. One from the Assistant Secretary of the HHS. substance as a result of control under commenter was in favor of controlling In accordance with 21 U.S.C. 811(c), the the CSA are not relevant factors to the alfaxalone as a schedule V controlled DEA conducted its own analysis of the determination whether a substance substance rather than a schedule IV eight factors determinative of control or should be controlled or under what controlled substance, and one removal: (1) Its actual or relative schedule a substance should be placed commenter opposed the control of potential for abuse; (2) scientific if it is controlled. See 21 U.S.C. 811 and alfaxalone. evidence of its pharmacological effect, if 812. Nonetheless, the DEA disagrees Support of the Proposed Rule: known; (3) the state of current scientific with the unsupported statement that Two commenters supported knowledge regarding the drug or other making alfaxalone a controlled controlling alfaxalone as a schedule IV substance; (4) its history and current substance would make it difficult for controlled substance. These commenters pattern of abuse; (5) the scope, duration, veterinarians and animal surgeons to

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acquire the drug. Several other for purposes of responding to this physical dependence or psychological anesthetic substances used by comment, the physical security dependence relative to the drugs or veterinarians and other practitioners are requirements for schedule IV and V other substances in schedule III. controlled under the CSA. All controlled substances are the same. Based on these findings, the veterinarians and animal surgeons who Also, under the CSA, schedule V Administrator of the DEA concludes are authorized by the State in which controlled substances may be dispensed that alfaxalone, including its salts, they practice to handle alfaxalone and without a prescription, while schedule isomers, and salts of isomers, warrants who are registered with the DEA to IV controlled substances may only be control in schedule IV of the CSA. 21 dispense controlled substances may dispensed pursuant to a prescription. U.S.C. 812(b)(4). acquire alfaxalone once it is controlled. However, this distinction is of no Requirements for Handling Alfaxalone As discussed in the Regulatory consequence with regard to alfaxalone Flexibility Analysis section of this because alfaxalone cannot be prescribed Upon the effective date of this final document, currently 98% of DEA by a veterinarian, nor may alfaxalone be rule, any person who handles alfaxalone registrants (most of which are small dispensed by a pharmacist pursuant to is subject to the CSA’s schedule IV businesses) are already authorized to a prescription. Federal law restricts this regulatory controls and administrative, handle schedule IV controlled drug to use by or on the order of a civil, and criminal sanctions applicable substances. licensed veterinarian (i.e., it may only to the manufacture, distribution, Request to Control Alfaxalone as a be administered). 21 CFR 522.52; see dispensing, importing, exporting, Schedule V Substance: also 21 CFR 514.8. engagement in research, and conduct of One commenter stated that alfaxalone instructional activities, of schedule IV should be controlled as a schedule V Scheduling Conclusion controlled substances including the controlled substance. This commenter Based on consideration of all following: stated that there was limited comments, the scientific and medical Registration. Any person who handles information available regarding evaluation and accompanying (manufactures, distributes, dispenses, alfaxalone’s abuse. The commenter also recommendation of the HHS, and based imports, exports, engages in research, or stated that alfaxalone is a new on the DEA’s consideration of its own conducts instructional activities with) introduction to the United States eight-factor analysis, the DEA finds that alfaxalone, or who desires to handle veterinary market, and controlling it in these facts and all other relevant data alfaxalone, must be registered with the the least stringent schedule, schedule V, constitute substantial evidence of DEA to conduct such activities, would minimize burdens on potential for abuse of alfaxalone. As pursuant to 21 U.S.C. 822, 823, 957 and practitioners using it for legitimate such, the DEA is scheduling alfaxalone 958, and in accordance with 21 CFR purposes, while also imposing controls as a controlled substance under the parts 1301 and 1312 as of March 31, to account for its abuse potential. CSA. 2014. Any person who currently DEA Response: The DEA does not handles alfaxalone and is not registered agree. The DEA thoroughly reviewed the Determination of Appropriate Schedule with the DEA must submit an scientific and medical evaluation and The CSA establishes five schedules of application for registration and may not the scheduling recommendation to controlled substances known as continue to handle alfaxalone as of control alfaxalone as a schedule IV schedules I, II, III, IV, and V. The CSA March 31, 2014 unless the DEA has controlled substance from the HHS. outlines the findings required for approved that application, pursuant to Additionally, the DEA conducted its placing a drug or other substance in any 21 U.S.C. 822, 823, 957, and 958, and own analysis of the eight factors in particular schedule. 21 U.S.C. 812(b). in accordance with 21 CFR parts 1301 accordance with 21 U.S.C. 811(b) and After consideration of the analysis and and 1312. made the findings required under 21 recommendation of the Assistant Security. Alfaxalone is subject to U.S.C. 812(b) for the placement of Secretary for Health of the HHS and schedule III–V security requirements alfaxalone in schedule IV. Based on the review of all available data, the and must be handled and stored review of the HHS’s evaluation and Administrator of the DEA, pursuant to pursuant to 21 U.S.C. 821, 823, and scheduling recommendation and all 21 U.S.C. 812(b)(4), finds that: 871(b) and in accordance with 21 CFR other relevant and available data, the (1) 5a-pregnan-3a-ol-11,20-dione 1301.71–1301.93, as of March 31, 2014. DEA found that alfaxalone has an abuse (alfaxalone) has a low potential for Labeling and Packaging. All labels potential similar to other schedule IV abuse relative to the drugs or other and labeling for commercial containers controlled substances, including the substances in schedule III; the overall of alfaxalone must comply with 21 benzodiazepines diazepam and abuse potential of alfaxalone is U.S.C. 825 and 958(e) and be in midazolam, barbiturates phenobarbital comparable to the schedule IV accordance with 21 CFR part 1302, as of and methohexital, and also the controlled substances diazepam, March 31, 2014. anesthetic agents propofol (proposed to midazolam, phenobarbital, Inventory. Every DEA registrant who be controlled as a schedule IV methohexital, propofol (proposed to be possesses any quantity of alfaxalone on substance, 75 FR 66195, Oct. 27, 2010) controlled as a schedule IV substance, the effective date of this final rule must and fospropofol. 75 FR 66195, Oct. 27, 2010), and to take an inventory of all stocks of While not relevant to the substance’s fospropofol; alfaxalone on hand as of March 31, schedule placement, the DEA does not (2) 5a-pregnan-3a-ol-11,20-dione 2014, pursuant to 21 U.S.C. 827 and agree with this commenter’s concern (alfaxalone) has a currently accepted 958, and in accordance with 21 CFR that the requirements applicable to medical use in treatment in the United 1304.03, 1304.04, and 1304.11(a) and schedule IV controlled substances are States; alfaxalone was approved for (d). more burdensome than the requirements marketing by the FDA as a veterinary Any person who becomes registered applicable to schedule V controlled anesthetic product for the induction and with the DEA after March 31, 2014 must substances. There are only very minimal maintenance of anesthesia in cats and in take an initial inventory of all stocks of differences in handling requirements dogs; and controlled substances (including between schedule IV and schedule V (3) Abuse of 5a-pregnan-3a-ol-11,20- alfaxalone) on hand on the date the controlled substances. Most importantly dione (alfaxalone) may lead to limited registrant first engages in the handling

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of controlled substances, pursuant to 21 Order 12866 and the principles product in the United States is not U.S.C. 827 and 958 and in accordance reaffirmed in Executive Order 13563. considered a ‘‘small entity’’ in with 21 CFR 1304.03, 1304.04, and accordance with the RFA and Small Executive Order 12988 1304.11(a) and (b). Business Administration (SBA) size After the initial inventory, every DEA This regulation meets the applicable standards. Upon expiration of the registrant must take a new inventory of standards set forth in sections 3(a) and exclusivity period, and more likely, the all stocks of controlled substances 3(b)(2) of Executive Order 12988 Civil related patent, additional products (including alfaxalone) on hand every Justice Reform to eliminate drafting containing alfaxalone may receive two years, pursuant to 21 U.S.C. 827 errors and ambiguity, minimize approvals from the FDA, and thus and 958, and in accordance with 21 CFR litigation, provide a clear legal standard additional manufacturers, distributors, 1304.03, 1304.04, and 1304.11. for affected conduct, and promote importers, and exporters will handle Records. All DEA registrants must simplification and burden reduction. alfaxalone. Whether such maintain records with respect to Executive Order 13132 manufacturers, distributors, importers, alfaxalone pursuant to 21 U.S.C. 827 or exporters may qualify as small and 958, and in accordance with 21 CFR This rulemaking does not have entities cannot be determined at this parts 1304, 1307, and 1312, as of March federalism implications warranting the time. 31, 2014. application of Executive Order 13132. There are currently approximately 1.5 Prescriptions. The DEA recognizes The rule does not have substantial million controlled substance that alfaxalone is currently only direct effects on the States, on the registrations, representing approved as an injectable anesthetic that relationship between the national approximately 381,000 entities. The is administered to patients. The DEA government and the States, or the DEA estimates that 371,000 (97%) of also acknowledges that Federal law distribution of power and these entities are considered ‘‘small currently restricts alfaxalone to use by responsibilities among the various entities’’ in accordance with the RFA or on the order of a licensed levels of government. and SBA size standards. 5 U.S.C. 601(6) and 15 U.S.C. 632. Due to the wide veterinarian, and it may not be Executive Order 13175 dispensed pursuant to a prescription. 21 variety of unidentifiable and CFR 522.52; see also 21 CFR 514.8. A This rule does not have tribal unquantifiable variables that potentially ‘‘prescription’’ is defined as an order for implications warranting the application could influence the dispensing rates of medication which is dispensed to or for of Executive Order 13175. The rule does new chemical entities, the DEA is an ultimate user but does not include an not have substantial direct effects on unable to determine the number of order for medication which is dispensed one or more Indian tribes, on the small entities which might handle for immediate administration to the relationship between the Federal alfaxalone. However, because alfaxalone ultimate user (e.g., an order to dispense Government and Indian tribes, or on the is a new chemical entity that is a a drug to a bed patient for immediate distribution of power and veterinary anesthetic administered in administration in a hospital is not a responsibilities between the Federal veterinary settings and is not prescribed prescription). 21 CFR 1300.01(b). Government and Indian tribes. to ultimate users, the number of entities However, any lawful prescriptions for Regulatory Flexibility Act affected by the rule would be far fewer than the 381,000 entities represented by alfaxalone or prescriptions for products The Administrator, in accordance containing alfaxalone must comply with all DEA registrants. There are with the Regulatory Flexibility Act approximately 66,361 veterinarian 21 U.S.C. 829 and must be issued in (RFA) (5 U.S.C. 601–612), has reviewed accordance with 21 CFR parts 1306 and practitioners and 23 veterinarian this final rule and by approving it distributors (schedules III–V) registered 1311 subpart C as of March 31, 2014. certifies that it will not have a Importation and Exportation. All with the DEA. significant economic impact on a Despite the fact that the number of importation and exportation of substantial number of small entities. alfaxalone must be in compliance with small entities possibly impacted by this The purpose of this final rule is to place rule could not be determined, the DEA 21 U.S.C. 952, 953, 957, and 958, and alfaxalone, including its salts, isomers, concludes that they would not be in accordance with 21 CFR part 1312 and salts of isomers, into schedule IV of experience a significant economic as of March 31, 2014. the CSA. By this final rule, alfaxalone impact as a result of this rule. The DEA Criminal Liability. Any activity will remain in schedule IV unless and estimates all anticipated alfaxalone involving alfaxalone not authorized by, until additional scheduling action is handlers to be DEA registrants, and or in violation of, the CSA, occurring as taken to either transfer it between the currently 98% of DEA registrants (most of March 31, 2014 is unlawful, and may schedules or to remove it from the list of which are small entities) are subject the person to administrative, of schedules. See 21 U.S.C. 811 and 812. authorized to handle schedule IV civil, and/or criminal sanctions. No less restrictive measures (i.e., no controlled substances. Even assuming Regulatory Analyses control or control in schedule V) enable that all of these registrants were to the DEA to meet its statutory obligations handle alfaxalone (e.g., practitioners Executive Orders 12866 and 13563 under the CSA. administer the substance), the costs that In accordance with 21 U.S.C. 811(a), On September 6, 2012, the FDA they would incur as a result of this scheduling action is subject to approved for use in the United States alfaxalone’s scheduling would be formal rulemaking procedures done ‘‘on one product containing alfaxalone, nominal. the record after opportunity for a which will have FDA marketing Registrants that dispense (e.g., hearing,’’ which are conducted pursuant exclusivity and patent protection for administer) alfaxalone are expected to to the provisions of 5 U.S.C. 556 and several years. Accordingly, the number incur nominal additional security, 557. The CSA sets forth the criteria for of currently identifiable manufacturers, inventory, and recordkeeping costs. scheduling a drug or other substance. distributors, importers, and exporters These registered entities have already Such actions are exempt from review by for alfaxalone is extremely small. The established and implemented the the Office of Management and Budget manufacturer who obtained FDA systems and processes required to pursuant to section 3(d)(1) of Executive approval for the sale of alfaxalone handle schedule IV controlled

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substances and can easily absorb the Review Act (CRA). This rule will not SUMMARY: This rule amends the policy costs of administering alfaxalone with result in: an annual effect on the of the Department of Justice regarding nominal to no additional economic economy of $100,000,000 or more; a the use of subpoenas, certain court burden. For example, because DEA- major increase in costs or prices for orders, and search warrants, to obtain veterinary practitioners are likely to consumers, individual industries, information from, or records of, already be schedule IV handlers, they Federal, State, or local government members of the news media. The rule already secure schedule II–V controlled agencies, or geographic regions; or also amends the Department’s policy substances in a securely locked, significant adverse effects on regarding questioning, arresting, or substantially constructed cabinet. See competition, employment, investment, charging members of the news media. 21 CFR 1301.75(b). Accordingly, the productivity, innovation, or on the DATES: This rule is effective on February requirement to secure all controlled ability of United States-based 27, 2014. substances containing alfaxalone would companies to compete with foreign not impose a significant economic based companies in domestic and FOR FURTHER INFORMATION CONTACT: burden upon DEA-registered export markets. However, pursuant to Monique Roth, Director, Office of practitioners as the infrastructure and the CRA, the DEA has submitted a copy Enforcement Operations, Criminal materials for doing so are already in of this final rule to both Houses of Division, (202) 514–6809. place. Labeling their products is routine Congress and to the Comptroller SUPPLEMENTARY INFORMATION: and in the normal course of business of General. Discussion manufacturers. The DEA therefore List of Subjects in 21 CFR Part 1308 assumes that the cost of compliance In May of 2013, the Department with 21 CFR part 1302 as a result of this Administrative practice and initiated a comprehensive evaluation of final rule is nominal. Correspondingly, procedure, Drug traffic control, its practices and policies regarding the the DEA estimates that the cost of the Reporting and recordkeeping use of subpoenas, court orders, and labeling and packaging requirements of requirements. search warrants to obtain information this final rule is nominal for the For the reasons set out above, 21 CFR from, or records of, members of the authorized manufacturer. Accordingly, part 1308 is amended as follows: news media. As part of this process, the compliance would not require Department convened a series of PART 1308—SCHEDULES OF significant additional manpower, capital meetings to solicit input from a wide CONTROLLED SUBSTANCES investment, or recordkeeping burdens. range of news media stakeholders, First Because of these facts, this rule will ■ 1. The authority citation for 21 CFR Amendment academics and advocates, not result in a significant economic part 1308 continues to read as follows: and Members of Congress. Based on this impact on a substantial number of small review, the Department issued a report entities. Authority: 21 U.S.C. 811, 812, 871(b), on July 12, 2013, announcing changes to unless otherwise noted. the Department’s policies. Unfunded Mandates Reform Act of 1995 ■ 2. Amend § 1308.14 by redesignating This final rule revises the existing In accordance with the Unfunded paragraphs (c)(1) through (c)(53) as provisions in the Department’s Mandates Reform Act (UMRA) of 1995 paragraphs (c)(2) through (c)(54) and regulations at 28 CFR 50.10. The (2 U.S.C. 1501 et seq.), the DEA has adding new paragraph (c)(1) to read as revisions are intended to ensure that, in determined and certifies pursuant to follows: determining whether to seek UMRA that this action would not result § 1308.14 Schedule IV. information from, or records of, in any Federal mandate that may result members of the news media, the ‘‘in the expenditure by State, local, and * * * * * (c) * * * Department strikes the proper balance tribal governments, in the aggregate, or among several vital interests: (1) by the private sector, of $100,000,000 or (1) Alfaxalone—(2731) * * * * * Protecting national security, (2) more (adjusted for inflation) in any one ensuring public safety, (3) promoting year * * * .’’ Therefore, neither a Small Dated: February 21, 2014. effective law enforcement and the fair Government Agency Plan nor any other Michele M. Leonhart, administration of justice, and (4) action is required under provisions of Administrator. safeguarding the essential role of the UMRA of 1995. [FR Doc. 2014–04332 Filed 2–26–14; 8:45 am] free press in fostering government Paperwork Reduction Act of 1995 BILLING CODE 4410–09–P accountability and an open society. This action does not impose a new The revisions also ensure more robust collection of information requirement oversight by senior Department officials; under the Paperwork Reduction Act of DEPARTMENT OF JUSTICE centralize the internal review and evaluation process; set out specific 1995. 44 U.S.C. 3501–3521. This action Office of the Attorney General would not impose recordkeeping or standards for the use and handling of information obtained from, or records reporting requirements on State or local 28 CFR Parts 50 and 59 governments, individuals, businesses, or of, members of the news media; and organizations. An agency may not [Docket No. 145; AG Order No. 3420–2014] extend the policies to cover the use of conduct or sponsor, and a person is not subpoenas, court orders issued pursuant required to respond to, a collection of Policy Regarding Obtaining to 18 U.S.C. 2703(d) and 3123, and information unless it displays a Information From, or Records of, search warrants. currently valid OMB control number. Members of the News Media; and The changes to the policy also Regarding Questioning, Arresting, or strengthen the presumption that Congressional Review Act Charging Members of the News Media Department attorneys will negotiate This rule is not a major rule as AGENCY: Office of the Attorney General, with, and provide advance notice to, defined by section 804 of the Small Department of Justice. affected members of the news media Business Regulatory Enforcement when investigators seek to obtain from ACTION: Final rule. Fairness Act of 1996 (Congressional third parties communications records or

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