Schedules of Controlled Substances: Placement of Suvorexant into Schedule IV, 51243-51247 [2014-20515]

Download as PDF Federal Register / Vol. 79, No. 167 / Thursday, August 28, 2014 / Rules and Regulations Authority: Secs. 205(a), 221, and 702(a)(5) of the Social Security Act (42 U.S.C. 405(a), 421, and 902(a)(5)). DEPARTMENT OF JUSTICE 2. Amend § 404.1615 by revising paragraph (c)(3) to read as follows: 21 CFR Part 1308 ■ [Docket No. DEA–381] § 404.1615 Making disability determinations. * * * * * (c) * * * (3) A State agency disability examiner alone if the claim is adjudicated under the quick disability determination process (see § 404.1619) or the compassionate allowance process (see § 404.1602), and the initial or reconsidered determination is fully favorable to you. This paragraph will no longer be effective on November 13, 2015 unless we terminate it earlier or extend it beyond that date by publication of a final rule in the Federal Register; or * * * * * PART 416—SUPPLEMENTAL SECURITY INCOME FOR THE AGED, BLIND, AND DISABLED Subpart J—[Amended] 3. The authority citation for subpart J continues to read as follows: ■ Authority: Secs. 702(a)(5), 1614, 1631, and 1633 of the Social Security Act (42 U.S.C. 902(a)(5), 1382c, 1383, and 1383b). 4. Amend § 416.1015 by revising paragraph (c)(3) to read as follows: ■ mstockstill on DSK4VPTVN1PROD with RULES * * * * * (c) * * * (3) A State agency disability examiner alone if you are not a child (a person who has not attained age 18), and the claim is adjudicated under the quick disability determination process (see § 416.1019) or the compassionate allowance process (see § 416.1002), and the initial or reconsidered determination is fully favorable to you. This paragraph will no longer be effective on November 13, 2015 unless we terminate it earlier or extend it beyond that date by publication of a final rule in the Federal Register; or * * * * * [FR Doc. 2014–20535 Filed 8–27–14; 8:45 am] BILLING CODE 4191–02–P 17:31 Aug 27, 2014 Schedules of Controlled Substances: Placement of Suvorexant into Schedule IV Drug Enforcement Administration, Department of Justice. ACTION: Final rule. AGENCY: With the issuance of this final rule, the Deputy Administrator of the Drug Enforcement Administration (DEA) places the substance [(7R)-4-(5chloro-1,3-benzoxazol-2-yl)-7-methyl1,4-diazepan-1-yl][5-methyl-2-(2H-1,2,3triazol-2-yl)phenyl]methanone (suvorexant), including its salts, isomers, and salts of isomers, into schedule IV of the Controlled Substances Act. This scheduling action is pursuant to the Controlled Substances Act which requires that such actions be made on the record after opportunity for a hearing through formal rulemaking. This action imposes the regulatory controls and administrative, civil, and criminal sanctions applicable to schedule IV controlled substances on persons who handle (manufacture, distribute, dispense, import, export, engage in research, conduct instructional activities, or possess), or propose to handle suvorexant. DATES: Effective Date: September 29, 2014. SUMMARY: FOR FURTHER INFORMATION CONTACT: § 416.1015 Making disability determinations. VerDate Mar<15>2010 Drug Enforcement Administration Jkt 232001 Imelda L. Paredes, Office of Diversion Control, Drug Enforcement Administration; Mailing Address: 8701 Morrissette Drive, Springfield, Virginia 22152, Telephone: (202) 598–6812. SUPPLEMENTARY INFORMATION: Legal Authority The DEA implements and enforces titles II and III of the Comprehensive Drug Abuse Prevention and Control Act of 1970, as amended. Titles II and III are referred to as the ‘‘Controlled Substances Act’’ and the ‘‘Controlled Substances Import and Export Act,’’ respectively, and are collectively referred to as the ‘‘Controlled Substances Act’’ or the ‘‘CSA’’ for the purpose of this action. 21 U.S.C. 801– 971. The DEA publishes the implementing regulations for these statutes in title 21 of the Code of Federal Regulations (CFR), parts 1300 to 1321. The CSA and its implementing regulations are designed to prevent, detect, and eliminate the diversion of PO 00000 Frm 00015 Fmt 4700 Sfmt 4700 51243 controlled substances and listed chemicals into the illicit market while providing for the legitimate medical, scientific, research, and industrial needs of the United States. Controlled substances have the potential for abuse and dependence and are controlled to protect the public health and safety. Under the CSA, each controlled substance is classified into one of five schedules based upon its potential for abuse, its currently accepted medical use in treatment in the United States, and the degree of dependence the substance may cause. 21 U.S.C. 812. The initial schedules of controlled substances established by Congress are found at 21 U.S.C. 812(c), and the current list of all scheduled substances is published at 21 CFR part 1308. Pursuant to 21 U.S.C. 811(a)(1), the Attorney General may, by rule, ‘‘add to such a schedule or transfer between such schedules any drug or other substance if he (A) finds that such drug or other substance has a potential for abuse, and (B) makes with respect to such drug or other substance the findings prescribed by [21 U.S.C. 812(b)] for the schedule in which such drug is to be placed * * *.’’ The Attorney General has delegated this authority to the Administrator of the DEA, 28 CFR 0.100, who in turn has redelegated that authority to the Deputy Administrator of the DEA. 28 CFR part 0, appendix to subpart R. The CSA provides that scheduling of any drug or other substance may be initiated by the Attorney General (1) on his own motion; (2) at the request of the Secretary of Health and Human Services (HHS); 1 or (3) on the petition of any interested party. 21 U.S.C. 811(a). This action imposes the regulatory controls and administrative, civil, and criminal sanctions of schedule IV controlled substances on persons who handle or propose to handle suvorexant. Background Suvorexant ([(7R)-4-(5-chloro-1,3benzoxazol-2-yl)-7-methyl-1,4-diazepan1-yl][5-methyl-2-(2H-1,2,3-triazol-2yl)phenyl]methanone), also known as MK–4305, is a new chemical entity developed for the treatment of insomnia. Suvorexant is a novel, first in class, orexin receptor antagonist with a 1 As set forth in a memorandum of understanding entered into by the HHS, the Food and Drug Administration (FDA), and the National Institute on Drug Abuse (NIDA), the FDA acts as the lead agency within the HHS in carrying out the Secretary’s scheduling responsibilities under the CSA, with the concurrence of NIDA. 50 FR 9518, Mar. 8, 1985. The Secretary of the HHS has delegated to the Assistant Secretary for Health of the HHS the authority to make domestic drug scheduling recommendations. E:\FR\FM\28AUR1.SGM 28AUR1 51244 Federal Register / Vol. 79, No. 167 / Thursday, August 28, 2014 / Rules and Regulations mechanism of action distinct from any marketed drug. It acts via inhibition of the orexin 1 (OX1) and orexin 2 (OX2) receptors. In pharmacological activity studies, suvorexant functioned as an antagonist as demonstrated by its ability to block agonist-induced calcium (Ca2+) release. The U.S. Food and Drug Administration (FDA) approved the new drug application for suvorexant on August 13, 2014. DEA and HHS Eight Factor Analyses On June 27, 2013, the HHS provided the DEA with a scientific and medical evaluation document prepared by the FDA entitled ‘‘Basis for the Recommendation to Place Suvorexant in Schedule IV of the Controlled Substances Act.’’ After considering the eight factors in 21 U.S.C. 811(c), including consideration of the substance’s abuse potential, legitimate medical use, and dependence liability, the Assistant Secretary of the HHS recommended that suvorexant be controlled in schedule IV of the CSA under 21 U.S.C. 812(b). In response, the DEA conducted its own eightfactor analysis of suvorexant pursuant to 21 U.S.C. 811(c). Both the DEA and HHS analyses are available in their entirety in the public docket for this rule (Docket Number DEA–381) at http:// www.regulations.gov under ‘‘Supporting and Related Material.’’ mstockstill on DSK4VPTVN1PROD with RULES Determination to Schedule Suvorexant After a review of the available data, including the scientific and medical evaluation and the scheduling recommendation from the HHS, the Deputy Administrator of the DEA published in the Federal Register a notice of proposed rulemaking (NPRM) entitled ‘‘Schedules of Controlled Substances: Placement of Suvorexant into Schedule IV’’ which proposed placement of suvorexant in schedule IV of the CSA. 79 FR 8639, Feb. 13, 2014. The proposed rule provided an opportunity for interested persons to file a request for hearing in accordance with DEA regulations by March 17, 2014. No requests for such a hearing were received by the DEA. The NPRM also provided an opportunity for interested persons to submit written comments on the proposal on or before March 17, 2014. Comments Received The DEA received five comments on the proposed rule to schedule suvorexant. Two commenters supported controlling suvorexant as a schedule IV controlled substance. One commenter opposed the control of suvorexant, one commenter did not articulate an official VerDate Mar<15>2010 17:31 Aug 27, 2014 Jkt 232001 position, and one commenter was in favor of controlling suvorexant as a schedule III controlled substance, rather than a schedule IV controlled substance. Support for the Proposed Rule Two commenters supported controlling suvorexant as a schedule IV controlled substance. These commenters indicated support for controlling suvorexant under the CSA based on the abuse potential of the substance. The commenters noted that controlling suvorexant as a schedule IV controlled substance is appropriate because it is similar to zolpidem (schedule IV), while one commenter stated that suvorexant produces fewer adverse effects than zolpidem. The commenters believe that controlling suvorexant as a schedule IV controlled substance will provide the necessary controls to prevent its diversion. DEA Response: The DEA appreciates the comments in support of this rulemaking. Opposition to the Proposed Rule Two commenters opposed the proposal to control suvorexant as a schedule IV controlled substance, and one commenter did not articulate an official position but expressed concern about the side effects of suvorexant. Request Not To Control Suvorexant One commenter opposed controlling suvorexant because they believed that there was a lack of strong scientific evidence that suvorexant has been abused, and the comparison of suvorexant with zolpidem (schedule IV) is incorrect due to each compound eliciting its effects via different mechanisms of action. The commenter was also concerned that controlling suvorexant will make it more difficult for patients to obtain the substance once it is approved by the FDA. DEA Response: The DEA does not agree. Suvorexant is a novel, first in class, new chemical substance and information on actual abuse data is not currently available. The legislative history of the CSA addresses the assessment of a new drug’s potential for abuse,2 and data from clinical studies 2 The legislative history of the CSA provides that a substance may have a potential for abuse if: ‘‘The drug or drugs containing such a substance are new drugs so related in their action to a drug or drugs already listed as having a potential for abuse to make it likely that the drug will have the same potentiality for abuse as such drugs, thus making it reasonable to assume that there may be significant diversions from legitimate channels, significant use contrary to or without medical advice, or that it has a substantial capability of creating hazards to the health of the user or to the safety of the community.’’ Comprehensive Drug Abuse PO 00000 Frm 00016 Fmt 4700 Sfmt 4700 investigating the abuse potential for suvorexant suggests that its effect is similar to zolpidem (schedule IV). Similarly, while the mechanism of action for suvorexant is distinct from any currently marketed drug for insomnia, human abuse potential studies demonstrated that suvorexant produced effects that were indistinguishable from zolpidem (schedule IV). Burdens associated with acquiring a substance as a result of control under the CSA are not relevant factors to the determination whether a substance should be controlled or under what schedule a substance should be placed if it is controlled. See 21 U.S.C. 811 and 812. Nonetheless, the DEA disagrees with the unsupported statement that making suvorexant a controlled substance will make it difficult for ultimate users to legally acquire the substance once it is approved by the FDA. If a DEA-registered practitioner lawfully prescribes suvorexant to treat a medical condition, it may be dispensed on the basis of an oral or written prescription. 21 CFR 1306.04(a), 1306.21. Request To Control Suvorexant as a Schedule III Substance One commenter had multiple concerns regarding the placement of suvorexant in schedule IV. The commenter believed that further studies on minimal levels of effective suvorexant doses should be conducted to reduce the risks of driving accidents. The commenter also expressed concern about the FDA’s statement that while effective, suvorexant is unsafe at various doses. This commenter believed that due to lack of conclusive findings, suvorexant should be categorized as a schedule III controlled substance for ‘‘safety and precautionary purposes’’ since it is a novel, first in class, new substance. Another commenter, who did not articulate a specific position, expressed concern that the side effects produced by suvorexant were similar to the effects of sleep deprivation, including cognitive and psychomotor impairment. DEA Response: The concerns about the limited research on minimal levels of effective suvorexant doses and the side effects of suvorexant and sleep deprivation, along with the statement that suvorexant is unsafe at various doses, are outside the scope of the DEA’s scheduling authority. As part of the new drug approval process, the HHS Prevention and Control Act of 1970, H.R. Rep. No. 91–1444 (1970); as reprinted in 1970 U.S.C.C.A.N. 4566, 4601. E:\FR\FM\28AUR1.SGM 28AUR1 mstockstill on DSK4VPTVN1PROD with RULES Federal Register / Vol. 79, No. 167 / Thursday, August 28, 2014 / Rules and Regulations provides scientific and medical evaluations of a drug or other substance to ensure that it is safe and effective for its intended use. This process is completely separate from the DEA’s proceedings to control such drug or other substance. 21 U.S.C. 811. The DEA does not agree that suvorexant should be controlled as a schedule III controlled substance. Pursuant to 21 U.S.C. 811(a)(1), the Attorney General may, by rule, ‘‘add to such a schedule or transfer between such schedules any drug or other substance if he (A) finds that such drug or other substance has a potential for abuse, and (B) makes with respect to such drug or other substance the findings prescribed by [21 U.S.C. 812(b)] for the schedule in which such drug is to be placed * * *.’’ This scheduling action was initiated when the DEA received a scientific and medical evaluation and a scheduling recommendation to control suvorexant as a schedule IV controlled substance from the Assistant Secretary of the HHS. In accordance with 21 U.S.C. 811(c), the DEA conducted its own analysis of the eight factors determinative of control or removal: (1) Its actual or relative potential for abuse; (2) scientific evidence of its pharmacological effect, if known; (3) the state of current scientific knowledge regarding the drug or other substance; (4) its history and current pattern of abuse; (5) the scope, duration, and significant of abuse; (6) what, if any, risk there is to the public health; (7) its psychic or physiological dependence liability; and (8) whether the substance is an immediate precursor of a substance already controlled. The summary of each factor as analyzed by the DEA and the HHS, and as considered by the DEA in this scheduling action, was provided in the proposed rule. Both the DEA and the HHS analyses have been made available in their entirety under ‘‘Supporting and Related Material’’ of the public docket for this rule at http:// www.regulations.gov under Docket Number DEA–381. There is evidence that suvorexant has a potential for abuse comparable to zolpidem (schedule IV), and like zolpidem, suvorexant has a low potential for abuse relative to the drugs or other substances in schedule III. Suvorexant was compared to zolpidem in human studies of recreational sedative users to measure its abuse potential relative to that of a sedativehypnotic in schedule IV. The abuse potential of suvorexant (40, 80 and 150 mg) relative to zolpidem (15 and 30 mg) and placebo was evaluated via a visual analog scale VAS, with results VerDate Mar<15>2010 17:31 Aug 27, 2014 Jkt 232001 demonstrating that the effects of suvorexant were statistically indistinguishable from zolpidem. The results of the human abuse potential study suggest that suvorexant and zolpidem produce similar reinforcing effects and have a similar potential for abuse. In addition, preclinical studies demonstrated that suvorexant (10, 20, 30 and 60 mg/kg) dose dependently reduced locomotor activity in rats, similar to other sedative drugs including zolpidem (schedule IV). Based on the review of the HHS evaluation and scheduling recommendation and all other relevant data, the DEA found that suvorexant has an abuse potential similar to other schedule IV drugs, including zolpidem (schedule IV). Scheduling Conclusion Based on consideration of all comments, the scientific and medical evaluation and accompanying recommendation of the HHS, and the DEA’s consideration of its own eightfactor analysis, the DEA finds that these facts and all other relevant data constitute substantial evidence of potential for abuse of suvorexant. As such, the DEA is scheduling suvorexant as a controlled substance under the CSA. Determination of Appropriate Schedule The CSA establishes five schedules of controlled substances known as schedules I, II, III, IV, and V. The CSA outlines the findings required for placing a drug or other substance in any particular schedule. 21 U.S.C. 812(b). After consideration of the analysis and recommendation of the Assistant Secretary for Health of the HHS and review of all available data, the Deputy Administrator of the DEA, pursuant to 21 U.S.C. 812(b)(4), finds that: (1) [(7R)-4-(5-chloro-1,3-benzoxazol-2yl)-7-methyl-1,4-diazepan-1-yl][5methyl-2-(2H–1,2,3-triazol-2yl)phenyl]methanone (suvorexant) has a low potential for abuse relative to the drugs or other substances in schedule III. The overall abuse potential of suvorexant is comparable to the schedule IV controlled substance zolpidem; (2) [(7R)-4-(5-chloro-1,3-benzoxazol-2yl)-7-methyl-1,4-diazepan-1-yl][5methyl-2-(2H–1,2,3-triazol-2yl)phenyl]methanone (suvorexant) has a currently accepted medical use in treatment in the United States. Suvorexant was approved for marketing by FDA as a treatment for insomnia; and (3) Abuse of [(7R)-4-(5-chloro-1,3benzoxazol-2-yl)-7-methyl-1,4-diazepan1-yl][5-methyl-2-(2H–1,2,3-triazol-2yl)phenyl]methanone (suvorexant) may PO 00000 Frm 00017 Fmt 4700 Sfmt 4700 51245 lead to limited physical dependence or psychological dependence relative to the drugs or other substances in schedule III. The potential for psychological dependence is similar to that of zolpidem (schedule IV). Based on these findings, the Deputy Administrator of the DEA concludes that suvorexant, including its salts, isomers, and salts of isomers, warrants control in schedule IV of the CSA. 21 U.S.C. 812(b)(4). Requirements for Handling Suvorexant Upon the effective date of this final rule, any person who handles suvorexant is subject to the CSA’s schedule IV regulatory controls and administrative, civil, and criminal sanctions applicable to the manufacture, distribution, dispensing, importing, exporting, engagement in research, and conduct of instructional activities, of schedule IV controlled substances including the following: Registration. Any person who handles (manufactures, distributes, dispenses, imports, exports, engages in research, or conducts instructional activities with) suvorexant, or who desires to handle suvorexant, must be registered with the DEA to conduct such activities, pursuant to 21 U.S.C. 822, 823, 957, and 958, and in accordance with 21 CFR parts 1301 and 1312 as of September 29, 2014. Any person who currently handles suvorexant and is not registered with the DEA must submit an application for registration and may not continue to handle suvorexant as of September 29, 2014 unless the DEA has approved that application, pursuant to 21 U.S.C. 822, 823, 957, and 958, and in accordance with 21 CFR parts 1301 and 1312. Security. Suvorexant is subject to schedule III–V security requirements and must be handled and stored pursuant to 21 U.S.C. 821, 823, and 871(b) and in accordance with 21 CFR 1301.71–1301.93, as of September 29, 2014. Labeling and Packaging. All labels, labeling, and packaging for commercial containers of suvorexant must comply with 21 U.S.C. 825 and 958(e) and be in accordance with 21 CFR part 1302, as of September 29, 2014. Inventory. Every DEA registrant who possesses any quantity of suvorexant on the effective date of this final rule must take an inventory of all stocks of suvorexant on hand as of September 29, 2014, pursuant to 21 U.S.C. 827 and 958, and in accordance with 21 CFR 1304.03, 1304.04, and 1304.11(a) and (d). Any person who becomes registered with the DEA after September 29, 2014 E:\FR\FM\28AUR1.SGM 28AUR1 51246 Federal Register / Vol. 79, No. 167 / Thursday, August 28, 2014 / Rules and Regulations must take an initial inventory of all stocks of controlled substances (including suvorexant) on hand on the date the registrant first engages in the handling of controlled substances, pursuant to 21 U.S.C. 827 and 958 and in accordance with 21 CFR 1304.03, 1304.04, and 1304.11(a) and (b). After the initial inventory, every DEA registrant must take a new inventory of all stocks of controlled substances (including suvorexant) on hand every two years, pursuant to 21 U.S.C. 827 and 958, and in accordance with 21 CFR 1304.03, 1304.04, and 1304.11. Records. All DEA registrants must maintain records with respect to suvorexant pursuant to 21 U.S.C. 827 and 958, and in accordance with 21 CFR parts 1304, 1307, and 1312, as of September 29, 2014. Prescriptions. All prescriptions for suvorexant or products containing suvorexant must comply with 21 U.S.C. 829, and be issued in accordance with 21 CFR part 1306 and subpart C of 21 CFR part 1311 as of September 29, 2014. Importation and Exportation. All importation and exportation of suvorexant must be in compliance with 21 U.S.C. 952, 953, 957, and 958, and be in accordance with 21 CFR part 1312 as of September 29, 2014. Liability. Any activity involving suvorexant not authorized by, or in violation of, the CSA, occurring as of September 29, 2014 is unlawful, and may subject the person to administrative, civil, and/or criminal proceedings. Regulatory Analyses Executive Orders 12866 and 13563 In accordance with 21 U.S.C. 811(a), this scheduling action is subject to formal rulemaking procedures done ‘‘on the record after opportunity for a hearing,’’ which are conducted pursuant to the provisions of 5 U.S.C. 556 and 557. The CSA sets forth the criteria for scheduling a drug or other substance. Such actions are exempt from review by the Office of Management and Budget pursuant to section 3(d)(1) of Executive Order 12866 and the principles reaffirmed in Executive Order 13563. mstockstill on DSK4VPTVN1PROD with RULES Executive Order 12988 This regulation meets the applicable standards set forth in sections 3(a) and 3(b)(2) of Executive Order 12988 Civil Justice Reform to eliminate drafting errors and ambiguity, minimize litigation, provide a clear legal standard for affected conduct, and promote simplification and burden reduction. VerDate Mar<15>2010 17:31 Aug 27, 2014 Jkt 232001 Executive Order 13132 This rulemaking does not have federalism implications warranting the application of Executive Order 13132. The rule does not have substantial direct effects on the States, on the relationship between the national government and the States, or the distribution of power and responsibilities among the various levels of government. Executive Order 13175 This rule does not have tribal implications warranting the application of Executive Order 13175. The rule does not have substantial direct effects on one or more Indian tribes, on the relationship between the Federal government and Indian tribes, or on the distribution of power and responsibilities between the Federal government and Indian tribes. Regulatory Flexibility Act The Deputy Administrator, in accordance with the Regulatory Flexibility Act (RFA), 5 U.S.C. 601–612, has reviewed this final rule and by approving it certifies that it will not have a significant economic impact on a substantial number of small entities. The purpose of this final rule is to place suvorexant, including its salts, isomers, and salts of isomers, into schedule IV of the CSA. No less restrictive measures (i.e., non-control, or control in schedule V) enable the DEA to meet its statutory obligations under the CSA. In preparing this certification, the DEA has assessed economic impact by size category and has considered costs with respect to the various DEA registrant business activity classes. Suvorexant is a new molecular entity which has not yet been marketed in the United States or any other country. Accordingly, the number of currently identifiable manufacturers, importers, and distributors for suvorexant is extremely small. The publicly available materials also specify the readily identifiable persons subject to direct regulation by this final rule. Based on guidelines utilized by the Small Business Administration (SBA), the suvorexant manufacturer/distributor/ importer was determined not to be a small entity. Once generic equivalents of suvorexant are developed and approved for manufacturing and marketing, there may be additional manufacturers, importers, and distributors of suvorexant, but whether they may qualify as small entities cannot be determined at this time. There are approximately 1.5 million controlled substance registrations that PO 00000 Frm 00018 Fmt 4700 Sfmt 4700 represent approximately 381,000 entities (which include businesses, organizations, and governmental jurisdictions). The DEA estimates that 371,000 (97%) of these entities are considered ‘‘small entities’’ in accordance with the RFA and SBA size standards. 5 U.S.C. 601(6); 15 U.S.C. 632. Due to the wide variety of unidentifiable and unquantifiable variables that potentially could influence the dispensing rates of new molecular entities, the DEA is unable to determine what number of these 371,000 small entities might handle suvorexant. Despite the fact that the number of small entities possibly impacted by this rule could not be determined, the DEA concludes that they would not experience a significant economic impact as a result of this final rule. The DEA estimates all anticipated suvorexant handlers to be DEA registrants and currently 98% of DEA registrants (most of which are small entities) are authorized to handle schedule IV controlled substances. Registrants that handle suvorexant are expected to incur nominal additional security, inventory, and recordkeeping costs. These registered entities are likely to have already established and implemented the systems and processes required to handle schedule IV controlled substances and can easily absorb the costs of handling suvorexant with nominal to no additional economic burden. For example, because DEA– registered pharmacies and institutional practitioners are likely to already be schedule IV handlers, they may secure schedule II–V controlled substances by dispersing such substances throughout the stock of noncontrolled substances in such a manner as to obstruct the theft or diversion of the controlled substances. Additionally, because other DEA registrants who will handle suvorexant are likely to already be schedule IV handlers, they already should have existing secure storage areas for schedule II–V controlled substances, which we assume would be able to accommodate any new stocks of suvorexant. See 21 CFR 1301.75(b), 1301.72(b). Accordingly, the requirement to secure all controlled substances containing suvorexant would not impose a significant economic burden upon DEA-registered practitioners as the infrastructure and materials for doing so are already in place. The DEA therefore assumes that the cost of compliance with 21 CFR 1301.71–1301.77 as a result of this final rule is nominal. Correspondingly, because DEAregistered manufacturers, distributors, E:\FR\FM\28AUR1.SGM 28AUR1 Federal Register / Vol. 79, No. 167 / Thursday, August 28, 2014 / Rules and Regulations and importers must label and package all schedule II–V controlled substances in accordance with 21 CFR part 1302, the requirement to label and package all controlled substances containing suvorexant in accordance with 21 CFR part 1302 would not impose a significant economic burden upon DEAregistered manufacturers, distributors, and importers as the infrastructure and materials for doing so would already be in place. Accordingly, compliance with 21 CFR part 1302 would not require significant additional manpower, capital investment, or recordkeeping burdens. Because of these facts, this final rule will not result in a significant economic impact on a substantial number of small entities. Unfunded Mandates Reform Act of 1995 In accordance with the Unfunded Mandates Reform Act (UMRA) of 1995 (2 U.S.C. 1501 et seq.), the DEA has determined and certifies pursuant to UMRA that this action would not result in any Federal mandate that may result ‘‘in the expenditure by State, local, and tribal governments, in the aggregate, or by the private sector, of $100,000,000 or more (adjusted for inflation) in any one year . . . .’’ Therefore, neither a Small Government Agency Plan nor any other action is required under provisions of UMRA of 1995. mstockstill on DSK4VPTVN1PROD with RULES Paperwork Reduction Act of 1995 This action does not impose a new collection of information requirement under the Paperwork Reduction Act of 1995. 44 U.S.C. 3501–3521. This action would not impose recordkeeping or reporting requirements on State or local governments, individuals, businesses, or organizations. An agency may not conduct or sponsor, and a person is not required to respond to, a collection of information unless it displays a currently valid OMB control number. Congressional Review Act This rule is not a major rule as defined by section 804 of the Small Business Regulatory Enforcement Fairness Act of 1996 (Congressional Review Act (CRA)). This rule will not result in: an annual effect on the economy of $100,000,000 or more; a major increase in costs or prices for consumers, individual industries, Federal, State, or local government agencies, or geographic regions; or significant adverse effects on competition, employment, investment, productivity, innovation, or on the ability of United States-based companies to compete with foreignbased companies in domestic and export markets. However, pursuant to VerDate Mar<15>2010 17:31 Aug 27, 2014 Jkt 232001 the CRA, the DEA has submitted a copy of this final rule to both Houses of Congress and to the Comptroller General. List of Subjects in 21 CFR Part 1308 Administrative practice and procedure, Drug traffic control, Reporting and recordkeeping requirements. For the reasons set out above, the DEA amends 21 CFR part 1308 as follows: PART 1308—SCHEDULES OF CONTROLLED SUBSTANCES 1. The authority citation for 21 CFR part 1308 continues to read as follows: ■ Authority: 21 U.S.C. 811, 812, 871(b), unless otherwise noted. 2. Amend § 1308.14 by redesignating paragraphs (c)(49) through (c)(54) as (c)(50) through (c)(55) and adding new paragraph (c)(49) to read as follows: ■ § 1308.14 Schedule IV. * * * * (c) * * * (49) Suvorexant * * * * * 2223 * Dated: August 21, 2014. Thomas M. Harrigan, Deputy Administrator. [FR Doc. 2014–20515 Filed 8–27–14; 8:45 am] BILLING CODE 4410–09–P DEPARTMENT OF STATE 22 CFR Part 22 [Public Notice: 8850] RIN 1400–AD47 Schedule of Fees for Consular Services, Department of State and Overseas Embassies and Consulates—Visa and Citizenship Services Fee Changes Department of State. Interim final rule. AGENCY: ACTION: PO 00000 Frm 00019 Fmt 4700 Sfmt 4700 immigrant visa services. Lastly, the rule raises the application processing fee for renunciation of U.S. citizenship and lowers the hourly consular officer time charge. The Department of State is adjusting the fees in light of the findings of a recent Cost of Service study to ensure that the fees for consular services better align with the costs of providing those services. DATES: This interim final rule becomes effective September 6, 2014. Written comments must be received on or before October 21, 2014. ADDRESSES: Interested parties may submit comments to the Department by any of the following methods: • Visit the Regulations.gov Web site at: http://www.regulations.gov and search the RIN 1400–AD47or docket number DOS–2014–0016. • Mail (paper, disk, or CD–ROM): U.S. Department of State, Office of the Comptroller, Bureau of Consular Affairs (CA/C), SA–17 8th Floor, Washington, DC 20522–1707. • E-Mail: fees@state.gov. You must include the RIN (1400–AD47) in the subject line of your message. • All comments should include the commenter’s name, the organization the commenter represents, if applicable, and the commenter’s address. If the Department is unable to read your comment for any reason, and cannot contact you for clarification, the Department may not be able to consider your comment. After the conclusion of the comment period, the Department will publish a Final Rule (in which it will address relevant comments) as expeditiously as possible. FOR FURTHER INFORMATION CONTACT: Celeste Scott, Special Assistant, Office of the Comptroller, Bureau of Consular Affairs, Department of State; phone: 202–485–6681, telefax: 202–485–6826; Email: fees@state.gov. SUPPLEMENTARY INFORMATION: Background The Department of State amends the Schedule of Fees for Consular Services (Schedule) for certain nonimmigrant visa application processing fees, certain immigrant visa application processing and special visa services fees, and certain citizenship services fees. More specifically, the rule amends the application processing fees for two categories of petition-based nonimmigrant visas and the tiered application processing fees for immigrant visas. The rule also amends the security surcharge for immigrant visa services and the fees for certain SUMMARY: 51247 The interim final rule makes changes to the Schedule of Fees for Consular Services of the Department of State’s Bureau of Consular Affairs. The Department sets and collects its fees based on the concept of full cost recovery. The Department completed its most recent review of current consular fees and will implement several changes to the Schedule of Fees based on the new fees calculated by the Cost of Service Model (CoSM). Please note that certain ‘‘no fee’’ consular services are included in the Schedule of Fees so that members of the public will be aware of significant consular services provided E:\FR\FM\28AUR1.SGM 28AUR1

Agencies

[Federal Register Volume 79, Number 167 (Thursday, August 28, 2014)]
[Rules and Regulations]
[Pages 51243-51247]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: 2014-20515]


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DEPARTMENT OF JUSTICE

Drug Enforcement Administration

21 CFR Part 1308

[Docket No. DEA-381]


Schedules of Controlled Substances: Placement of Suvorexant into 
Schedule IV

AGENCY: Drug Enforcement Administration, Department of Justice.

ACTION: Final rule.

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SUMMARY: With the issuance of this final rule, the Deputy Administrator 
of the Drug Enforcement Administration (DEA) places the substance 
[(7R)-4-(5-chloro-1,3-benzoxazol-2-yl)-7-methyl-1,4-diazepan-1-yl][5-
methyl-2-(2H-1,2,3-triazol-2-yl)phenyl]methanone (suvorexant), 
including its salts, isomers, and salts of isomers, into schedule IV of 
the Controlled Substances Act. This scheduling action is pursuant to 
the Controlled Substances Act which requires that such actions be made 
on the record after opportunity for a hearing through formal 
rulemaking. This action imposes the regulatory controls and 
administrative, civil, and criminal sanctions applicable to schedule IV 
controlled substances on persons who handle (manufacture, distribute, 
dispense, import, export, engage in research, conduct instructional 
activities, or possess), or propose to handle suvorexant.

DATES: Effective Date: September 29, 2014.

FOR FURTHER INFORMATION CONTACT: Imelda L. Paredes, Office of Diversion 
Control, Drug Enforcement Administration; Mailing Address: 8701 
Morrissette Drive, Springfield, Virginia 22152, Telephone: (202) 598-
6812.

SUPPLEMENTARY INFORMATION: 

Legal Authority

    The DEA implements and enforces titles II and III of the 
Comprehensive Drug Abuse Prevention and Control Act of 1970, as 
amended. Titles II and III are referred to as the ``Controlled 
Substances Act'' and the ``Controlled Substances Import and Export 
Act,'' respectively, and are collectively referred to as the 
``Controlled Substances Act'' or the ``CSA'' for the purpose of this 
action. 21 U.S.C. 801-971. The DEA publishes the implementing 
regulations for these statutes in title 21 of the Code of Federal 
Regulations (CFR), parts 1300 to 1321. The CSA and its implementing 
regulations are designed to prevent, detect, and eliminate the 
diversion of controlled substances and listed chemicals into the 
illicit market while providing for the legitimate medical, scientific, 
research, and industrial needs of the United States. Controlled 
substances have the potential for abuse and dependence and are 
controlled to protect the public health and safety.
    Under the CSA, each controlled substance is classified into one of 
five schedules based upon its potential for abuse, its currently 
accepted medical use in treatment in the United States, and the degree 
of dependence the substance may cause. 21 U.S.C. 812. The initial 
schedules of controlled substances established by Congress are found at 
21 U.S.C. 812(c), and the current list of all scheduled substances is 
published at 21 CFR part 1308.
    Pursuant to 21 U.S.C. 811(a)(1), the Attorney General may, by rule, 
``add to such a schedule or transfer between such schedules any drug or 
other substance if he (A) finds that such drug or other substance has a 
potential for abuse, and (B) makes with respect to such drug or other 
substance the findings prescribed by [21 U.S.C. 812(b)] for the 
schedule in which such drug is to be placed * * *.'' The Attorney 
General has delegated this authority to the Administrator of the DEA, 
28 CFR 0.100, who in turn has redelegated that authority to the Deputy 
Administrator of the DEA. 28 CFR part 0, appendix to subpart R.
    The CSA provides that scheduling of any drug or other substance may 
be initiated by the Attorney General (1) on his own motion; (2) at the 
request of the Secretary of Health and Human Services (HHS); \1\ or (3) 
on the petition of any interested party. 21 U.S.C. 811(a). This action 
imposes the regulatory controls and administrative, civil, and criminal 
sanctions of schedule IV controlled substances on persons who handle or 
propose to handle suvorexant.
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    \1\ As set forth in a memorandum of understanding entered into 
by the HHS, the Food and Drug Administration (FDA), and the National 
Institute on Drug Abuse (NIDA), the FDA acts as the lead agency 
within the HHS in carrying out the Secretary's scheduling 
responsibilities under the CSA, with the concurrence of NIDA. 50 FR 
9518, Mar. 8, 1985. The Secretary of the HHS has delegated to the 
Assistant Secretary for Health of the HHS the authority to make 
domestic drug scheduling recommendations.
---------------------------------------------------------------------------

Background

    Suvorexant ([(7R)-4-(5-chloro-1,3-benzoxazol-2-yl)-7-methyl-1,4-
diazepan-1-yl][5-methyl-2-(2H-1,2,3-triazol-2-yl)phenyl]methanone), 
also known as MK-4305, is a new chemical entity developed for the 
treatment of insomnia. Suvorexant is a novel, first in class, orexin 
receptor antagonist with a

[[Page 51244]]

mechanism of action distinct from any marketed drug. It acts via 
inhibition of the orexin 1 (OX1) and orexin 2 (OX2) receptors. In 
pharmacological activity studies, suvorexant functioned as an 
antagonist as demonstrated by its ability to block agonist-induced 
calcium (Ca\2+\) release. The U.S. Food and Drug Administration (FDA) 
approved the new drug application for suvorexant on August 13, 2014.

DEA and HHS Eight Factor Analyses

    On June 27, 2013, the HHS provided the DEA with a scientific and 
medical evaluation document prepared by the FDA entitled ``Basis for 
the Recommendation to Place Suvorexant in Schedule IV of the Controlled 
Substances Act.'' After considering the eight factors in 21 U.S.C. 
811(c), including consideration of the substance's abuse potential, 
legitimate medical use, and dependence liability, the Assistant 
Secretary of the HHS recommended that suvorexant be controlled in 
schedule IV of the CSA under 21 U.S.C. 812(b). In response, the DEA 
conducted its own eightfactor analysis of suvorexant pursuant to 21 
U.S.C. 811(c). Both the DEA and HHS analyses are available in their 
entirety in the public docket for this rule (Docket Number DEA-381) at 
http://www.regulations.gov under ``Supporting and Related Material.''

Determination to Schedule Suvorexant

    After a review of the available data, including the scientific and 
medical evaluation and the scheduling recommendation from the HHS, the 
Deputy Administrator of the DEA published in the Federal Register a 
notice of proposed rulemaking (NPRM) entitled ``Schedules of Controlled 
Substances: Placement of Suvorexant into Schedule IV'' which proposed 
placement of suvorexant in schedule IV of the CSA. 79 FR 8639, Feb. 13, 
2014. The proposed rule provided an opportunity for interested persons 
to file a request for hearing in accordance with DEA regulations by 
March 17, 2014. No requests for such a hearing were received by the 
DEA. The NPRM also provided an opportunity for interested persons to 
submit written comments on the proposal on or before March 17, 2014.

Comments Received

    The DEA received five comments on the proposed rule to schedule 
suvorexant. Two commenters supported controlling suvorexant as a 
schedule IV controlled substance. One commenter opposed the control of 
suvorexant, one commenter did not articulate an official position, and 
one commenter was in favor of controlling suvorexant as a schedule III 
controlled substance, rather than a schedule IV controlled substance.

Support for the Proposed Rule

    Two commenters supported controlling suvorexant as a schedule IV 
controlled substance. These commenters indicated support for 
controlling suvorexant under the CSA based on the abuse potential of 
the substance. The commenters noted that controlling suvorexant as a 
schedule IV controlled substance is appropriate because it is similar 
to zolpidem (schedule IV), while one commenter stated that suvorexant 
produces fewer adverse effects than zolpidem. The commenters believe 
that controlling suvorexant as a schedule IV controlled substance will 
provide the necessary controls to prevent its diversion.
    DEA Response: The DEA appreciates the comments in support of this 
rulemaking.

Opposition to the Proposed Rule

    Two commenters opposed the proposal to control suvorexant as a 
schedule IV controlled substance, and one commenter did not articulate 
an official position but expressed concern about the side effects of 
suvorexant.

Request Not To Control Suvorexant

    One commenter opposed controlling suvorexant because they believed 
that there was a lack of strong scientific evidence that suvorexant has 
been abused, and the comparison of suvorexant with zolpidem (schedule 
IV) is incorrect due to each compound eliciting its effects via 
different mechanisms of action. The commenter was also concerned that 
controlling suvorexant will make it more difficult for patients to 
obtain the substance once it is approved by the FDA.
    DEA Response: The DEA does not agree. Suvorexant is a novel, first 
in class, new chemical substance and information on actual abuse data 
is not currently available. The legislative history of the CSA 
addresses the assessment of a new drug's potential for abuse,\2\ and 
data from clinical studies investigating the abuse potential for 
suvorexant suggests that its effect is similar to zolpidem (schedule 
IV). Similarly, while the mechanism of action for suvorexant is 
distinct from any currently marketed drug for insomnia, human abuse 
potential studies demonstrated that suvorexant produced effects that 
were indistinguishable from zolpidem (schedule IV).
---------------------------------------------------------------------------

    \2\ The legislative history of the CSA provides that a substance 
may have a potential for abuse if: ``The drug or drugs containing 
such a substance are new drugs so related in their action to a drug 
or drugs already listed as having a potential for abuse to make it 
likely that the drug will have the same potentiality for abuse as 
such drugs, thus making it reasonable to assume that there may be 
significant diversions from legitimate channels, significant use 
contrary to or without medical advice, or that it has a substantial 
capability of creating hazards to the health of the user or to the 
safety of the community.'' Comprehensive Drug Abuse Prevention and 
Control Act of 1970, H.R. Rep. No. 91-1444 (1970); as reprinted in 
1970 U.S.C.C.A.N. 4566, 4601.
---------------------------------------------------------------------------

    Burdens associated with acquiring a substance as a result of 
control under the CSA are not relevant factors to the determination 
whether a substance should be controlled or under what schedule a 
substance should be placed if it is controlled. See 21 U.S.C. 811 and 
812. Nonetheless, the DEA disagrees with the unsupported statement that 
making suvorexant a controlled substance will make it difficult for 
ultimate users to legally acquire the substance once it is approved by 
the FDA. If a DEA-registered practitioner lawfully prescribes 
suvorexant to treat a medical condition, it may be dispensed on the 
basis of an oral or written prescription. 21 CFR 1306.04(a), 1306.21.

Request To Control Suvorexant as a Schedule III Substance

    One commenter had multiple concerns regarding the placement of 
suvorexant in schedule IV. The commenter believed that further studies 
on minimal levels of effective suvorexant doses should be conducted to 
reduce the risks of driving accidents. The commenter also expressed 
concern about the FDA's statement that while effective, suvorexant is 
unsafe at various doses. This commenter believed that due to lack of 
conclusive findings, suvorexant should be categorized as a schedule III 
controlled substance for ``safety and precautionary purposes'' since it 
is a novel, first in class, new substance.
    Another commenter, who did not articulate a specific position, 
expressed concern that the side effects produced by suvorexant were 
similar to the effects of sleep deprivation, including cognitive and 
psychomotor impairment.
    DEA Response: The concerns about the limited research on minimal 
levels of effective suvorexant doses and the side effects of suvorexant 
and sleep deprivation, along with the statement that suvorexant is 
unsafe at various doses, are outside the scope of the DEA's scheduling 
authority. As part of the new drug approval process, the HHS

[[Page 51245]]

provides scientific and medical evaluations of a drug or other 
substance to ensure that it is safe and effective for its intended use. 
This process is completely separate from the DEA's proceedings to 
control such drug or other substance. 21 U.S.C. 811.
    The DEA does not agree that suvorexant should be controlled as a 
schedule III controlled substance. Pursuant to 21 U.S.C. 811(a)(1), the 
Attorney General may, by rule, ``add to such a schedule or transfer 
between such schedules any drug or other substance if he (A) finds that 
such drug or other substance has a potential for abuse, and (B) makes 
with respect to such drug or other substance the findings prescribed by 
[21 U.S.C. 812(b)] for the schedule in which such drug is to be placed 
* * *.'' This scheduling action was initiated when the DEA received a 
scientific and medical evaluation and a scheduling recommendation to 
control suvorexant as a schedule IV controlled substance from the 
Assistant Secretary of the HHS. In accordance with 21 U.S.C. 811(c), 
the DEA conducted its own analysis of the eight factors determinative 
of control or removal: (1) Its actual or relative potential for abuse; 
(2) scientific evidence of its pharmacological effect, if known; (3) 
the state of current scientific knowledge regarding the drug or other 
substance; (4) its history and current pattern of abuse; (5) the scope, 
duration, and significant of abuse; (6) what, if any, risk there is to 
the public health; (7) its psychic or physiological dependence 
liability; and (8) whether the substance is an immediate precursor of a 
substance already controlled. The summary of each factor as analyzed by 
the DEA and the HHS, and as considered by the DEA in this scheduling 
action, was provided in the proposed rule. Both the DEA and the HHS 
analyses have been made available in their entirety under ``Supporting 
and Related Material'' of the public docket for this rule at http://www.regulations.gov under Docket Number DEA-381.
    There is evidence that suvorexant has a potential for abuse 
comparable to zolpidem (schedule IV), and like zolpidem, suvorexant has 
a low potential for abuse relative to the drugs or other substances in 
schedule III. Suvorexant was compared to zolpidem in human studies of 
recreational sedative users to measure its abuse potential relative to 
that of a sedative-hypnotic in schedule IV. The abuse potential of 
suvorexant (40, 80 and 150 mg) relative to zolpidem (15 and 30 mg) and 
placebo was evaluated via a visual analog scale VAS, with results 
demonstrating that the effects of suvorexant were statistically 
indistinguishable from zolpidem. The results of the human abuse 
potential study suggest that suvorexant and zolpidem produce similar 
reinforcing effects and have a similar potential for abuse. In 
addition, preclinical studies demonstrated that suvorexant (10, 20, 30 
and 60 mg/kg) dose dependently reduced locomotor activity in rats, 
similar to other sedative drugs including zolpidem (schedule IV). Based 
on the review of the HHS evaluation and scheduling recommendation and 
all other relevant data, the DEA found that suvorexant has an abuse 
potential similar to other schedule IV drugs, including zolpidem 
(schedule IV).

Scheduling Conclusion

    Based on consideration of all comments, the scientific and medical 
evaluation and accompanying recommendation of the HHS, and the DEA's 
consideration of its own eight-factor analysis, the DEA finds that 
these facts and all other relevant data constitute substantial evidence 
of potential for abuse of suvorexant. As such, the DEA is scheduling 
suvorexant as a controlled substance under the CSA.

Determination of Appropriate Schedule

    The CSA establishes five schedules of controlled substances known 
as schedules I, II, III, IV, and V. The CSA outlines the findings 
required for placing a drug or other substance in any particular 
schedule. 21 U.S.C. 812(b). After consideration of the analysis and 
recommendation of the Assistant Secretary for Health of the HHS and 
review of all available data, the Deputy Administrator of the DEA, 
pursuant to 21 U.S.C. 812(b)(4), finds that:
    (1) [(7R)-4-(5-chloro-1,3-benzoxazol-2-yl)-7-methyl-1,4-diazepan-1-
yl][5-methyl-2-(2H-1,2,3-triazol-2-yl)phenyl]methanone (suvorexant) has 
a low potential for abuse relative to the drugs or other substances in 
schedule III. The overall abuse potential of suvorexant is comparable 
to the schedule IV controlled substance zolpidem;
    (2) [(7R)-4-(5-chloro-1,3-benzoxazol-2-yl)-7-methyl-1,4-diazepan-1-
yl][5-methyl-2-(2H-1,2,3-triazol-2-yl)phenyl]methanone (suvorexant) has 
a currently accepted medical use in treatment in the United States. 
Suvorexant was approved for marketing by FDA as a treatment for 
insomnia; and
    (3) Abuse of [(7R)-4-(5-chloro-1,3-benzoxazol-2-yl)-7-methyl-1,4-
diazepan-1-yl][5-methyl-2-(2H-1,2,3-triazol-2-yl)phenyl]methanone 
(suvorexant) may lead to limited physical dependence or psychological 
dependence relative to the drugs or other substances in schedule III. 
The potential for psychological dependence is similar to that of 
zolpidem (schedule IV).
    Based on these findings, the Deputy Administrator of the DEA 
concludes that suvorexant, including its salts, isomers, and salts of 
isomers, warrants control in schedule IV of the CSA. 21 U.S.C. 
812(b)(4).

Requirements for Handling Suvorexant

    Upon the effective date of this final rule, any person who handles 
suvorexant is subject to the CSA's schedule IV regulatory controls and 
administrative, civil, and criminal sanctions applicable to the 
manufacture, distribution, dispensing, importing, exporting, engagement 
in research, and conduct of instructional activities, of schedule IV 
controlled substances including the following:
    Registration. Any person who handles (manufactures, distributes, 
dispenses, imports, exports, engages in research, or conducts 
instructional activities with) suvorexant, or who desires to handle 
suvorexant, must be registered with the DEA to conduct such activities, 
pursuant to 21 U.S.C. 822, 823, 957, and 958, and in accordance with 21 
CFR parts 1301 and 1312 as of September 29, 2014. Any person who 
currently handles suvorexant and is not registered with the DEA must 
submit an application for registration and may not continue to handle 
suvorexant as of September 29, 2014 unless the DEA has approved that 
application, pursuant to 21 U.S.C. 822, 823, 957, and 958, and in 
accordance with 21 CFR parts 1301 and 1312.
    Security. Suvorexant is subject to schedule III-V security 
requirements and must be handled and stored pursuant to 21 U.S.C. 821, 
823, and 871(b) and in accordance with 21 CFR 1301.71-1301.93, as of 
September 29, 2014.
    Labeling and Packaging. All labels, labeling, and packaging for 
commercial containers of suvorexant must comply with 21 U.S.C. 825 and 
958(e) and be in accordance with 21 CFR part 1302, as of September 29, 
2014.
    Inventory. Every DEA registrant who possesses any quantity of 
suvorexant on the effective date of this final rule must take an 
inventory of all stocks of suvorexant on hand as of September 29, 2014, 
pursuant to 21 U.S.C. 827 and 958, and in accordance with 21 CFR 
1304.03, 1304.04, and 1304.11(a) and (d).
    Any person who becomes registered with the DEA after September 29, 
2014

[[Page 51246]]

must take an initial inventory of all stocks of controlled substances 
(including suvorexant) on hand on the date the registrant first engages 
in the handling of controlled substances, pursuant to 21 U.S.C. 827 and 
958 and in accordance with 21 CFR 1304.03, 1304.04, and 1304.11(a) and 
(b).
    After the initial inventory, every DEA registrant must take a new 
inventory of all stocks of controlled substances (including suvorexant) 
on hand every two years, pursuant to 21 U.S.C. 827 and 958, and in 
accordance with 21 CFR 1304.03, 1304.04, and 1304.11.
    Records. All DEA registrants must maintain records with respect to 
suvorexant pursuant to 21 U.S.C. 827 and 958, and in accordance with 21 
CFR parts 1304, 1307, and 1312, as of September 29, 2014.
    Prescriptions. All prescriptions for suvorexant or products 
containing suvorexant must comply with 21 U.S.C. 829, and be issued in 
accordance with 21 CFR part 1306 and subpart C of 21 CFR part 1311 as 
of September 29, 2014.
    Importation and Exportation. All importation and exportation of 
suvorexant must be in compliance with 21 U.S.C. 952, 953, 957, and 958, 
and be in accordance with 21 CFR part 1312 as of September 29, 2014.
    Liability. Any activity involving suvorexant not authorized by, or 
in violation of, the CSA, occurring as of September 29, 2014 is 
unlawful, and may subject the person to administrative, civil, and/or 
criminal proceedings.

Regulatory Analyses

Executive Orders 12866 and 13563

    In accordance with 21 U.S.C. 811(a), this scheduling action is 
subject to formal rulemaking procedures done ``on the record after 
opportunity for a hearing,'' which are conducted pursuant to the 
provisions of 5 U.S.C. 556 and 557. The CSA sets forth the criteria for 
scheduling a drug or other substance. Such actions are exempt from 
review by the Office of Management and Budget pursuant to section 
3(d)(1) of Executive Order 12866 and the principles reaffirmed in 
Executive Order 13563.

Executive Order 12988

    This regulation meets the applicable standards set forth in 
sections 3(a) and 3(b)(2) of Executive Order 12988 Civil Justice Reform 
to eliminate drafting errors and ambiguity, minimize litigation, 
provide a clear legal standard for affected conduct, and promote 
simplification and burden reduction.

Executive Order 13132

    This rulemaking does not have federalism implications warranting 
the application of Executive Order 13132. The rule does not have 
substantial direct effects on the States, on the relationship between 
the national government and the States, or the distribution of power 
and responsibilities among the various levels of government.

Executive Order 13175

    This rule does not have tribal implications warranting the 
application of Executive Order 13175. The rule does not have 
substantial direct effects on one or more Indian tribes, on the 
relationship between the Federal government and Indian tribes, or on 
the distribution of power and responsibilities between the Federal 
government and Indian tribes.

Regulatory Flexibility Act

    The Deputy Administrator, in accordance with the Regulatory 
Flexibility Act (RFA), 5 U.S.C. 601-612, has reviewed this final rule 
and by approving it certifies that it will not have a significant 
economic impact on a substantial number of small entities. The purpose 
of this final rule is to place suvorexant, including its salts, 
isomers, and salts of isomers, into schedule IV of the CSA. No less 
restrictive measures (i.e., non-control, or control in schedule V) 
enable the DEA to meet its statutory obligations under the CSA. In 
preparing this certification, the DEA has assessed economic impact by 
size category and has considered costs with respect to the various DEA 
registrant business activity classes.
    Suvorexant is a new molecular entity which has not yet been 
marketed in the United States or any other country. Accordingly, the 
number of currently identifiable manufacturers, importers, and 
distributors for suvorexant is extremely small. The publicly available 
materials also specify the readily identifiable persons subject to 
direct regulation by this final rule. Based on guidelines utilized by 
the Small Business Administration (SBA), the suvorexant manufacturer/
distributor/importer was determined not to be a small entity. Once 
generic equivalents of suvorexant are developed and approved for 
manufacturing and marketing, there may be additional manufacturers, 
importers, and distributors of suvorexant, but whether they may qualify 
as small entities cannot be determined at this time.
    There are approximately 1.5 million controlled substance 
registrations that represent approximately 381,000 entities (which 
include businesses, organizations, and governmental jurisdictions). The 
DEA estimates that 371,000 (97%) of these entities are considered 
``small entities'' in accordance with the RFA and SBA size standards. 5 
U.S.C. 601(6); 15 U.S.C. 632. Due to the wide variety of unidentifiable 
and unquantifiable variables that potentially could influence the 
dispensing rates of new molecular entities, the DEA is unable to 
determine what number of these 371,000 small entities might handle 
suvorexant.
    Despite the fact that the number of small entities possibly 
impacted by this rule could not be determined, the DEA concludes that 
they would not experience a significant economic impact as a result of 
this final rule. The DEA estimates all anticipated suvorexant handlers 
to be DEA registrants and currently 98% of DEA registrants (most of 
which are small entities) are authorized to handle schedule IV 
controlled substances. Registrants that handle suvorexant are expected 
to incur nominal additional security, inventory, and recordkeeping 
costs. These registered entities are likely to have already established 
and implemented the systems and processes required to handle schedule 
IV controlled substances and can easily absorb the costs of handling 
suvorexant with nominal to no additional economic burden. For example, 
because DEA-registered pharmacies and institutional practitioners are 
likely to already be schedule IV handlers, they may secure schedule II-
V controlled substances by dispersing such substances throughout the 
stock of noncontrolled substances in such a manner as to obstruct the 
theft or diversion of the controlled substances. Additionally, because 
other DEA registrants who will handle suvorexant are likely to already 
be schedule IV handlers, they already should have existing secure 
storage areas for schedule II-V controlled substances, which we assume 
would be able to accommodate any new stocks of suvorexant. See 21 CFR 
1301.75(b), 1301.72(b). Accordingly, the requirement to secure all 
controlled substances containing suvorexant would not impose a 
significant economic burden upon DEA-registered practitioners as the 
infrastructure and materials for doing so are already in place. The DEA 
therefore assumes that the cost of compliance with 21 CFR 1301.71-
1301.77 as a result of this final rule is nominal.
    Correspondingly, because DEA-registered manufacturers, 
distributors,

[[Page 51247]]

and importers must label and package all schedule II-V controlled 
substances in accordance with 21 CFR part 1302, the requirement to 
label and package all controlled substances containing suvorexant in 
accordance with 21 CFR part 1302 would not impose a significant 
economic burden upon DEA-registered manufacturers, distributors, and 
importers as the infrastructure and materials for doing so would 
already be in place. Accordingly, compliance with 21 CFR part 1302 
would not require significant additional manpower, capital investment, 
or recordkeeping burdens.
    Because of these facts, this final rule will not result in a 
significant economic impact on a substantial number of small entities.

Unfunded Mandates Reform Act of 1995

    In accordance with the Unfunded Mandates Reform Act (UMRA) of 1995 
(2 U.S.C. 1501 et seq.), the DEA has determined and certifies pursuant 
to UMRA that this action would not result in any Federal mandate that 
may result ``in the expenditure by State, local, and tribal 
governments, in the aggregate, or by the private sector, of 
$100,000,000 or more (adjusted for inflation) in any one year . . . .'' 
Therefore, neither a Small Government Agency Plan nor any other action 
is required under provisions of UMRA of 1995.

Paperwork Reduction Act of 1995

    This action does not impose a new collection of information 
requirement under the Paperwork Reduction Act of 1995. 44 U.S.C. 3501-
3521. This action would not impose recordkeeping or reporting 
requirements on State or local governments, individuals, businesses, or 
organizations. An agency may not conduct or sponsor, and a person is 
not required to respond to, a collection of information unless it 
displays a currently valid OMB control number.

Congressional Review Act

    This rule is not a major rule as defined by section 804 of the 
Small Business Regulatory Enforcement Fairness Act of 1996 
(Congressional Review Act (CRA)). This rule will not result in: an 
annual effect on the economy of $100,000,000 or more; a major increase 
in costs or prices for consumers, individual industries, Federal, 
State, or local government agencies, or geographic regions; or 
significant adverse effects on competition, employment, investment, 
productivity, innovation, or on the ability of United States-based 
companies to compete with foreign-based companies in domestic and 
export markets. However, pursuant to the CRA, the DEA has submitted a 
copy of this final rule to both Houses of Congress and to the 
Comptroller General.

List of Subjects in 21 CFR Part 1308

    Administrative practice and procedure, Drug traffic control, 
Reporting and recordkeeping requirements.

    For the reasons set out above, the DEA amends 21 CFR part 1308 as 
follows:

PART 1308--SCHEDULES OF CONTROLLED SUBSTANCES

0
1. The authority citation for 21 CFR part 1308 continues to read as 
follows:

    Authority:  21 U.S.C. 811, 812, 871(b), unless otherwise noted.


0
2. Amend Sec.  1308.14 by redesignating paragraphs (c)(49) through 
(c)(54) as (c)(50) through (c)(55) and adding new paragraph (c)(49) to 
read as follows:


Sec.  1308.14  Schedule IV.

* * * * *
    (c) * * *
    (49) Suvorexant 2223
* * * * *

    Dated: August 21, 2014.
Thomas M. Harrigan,
Deputy Administrator.
[FR Doc. 2014-20515 Filed 8-27-14; 8:45 am]
BILLING CODE 4410-09-P