Schedules of Controlled Substances: Placement of Lorcaserin Into Schedule IV, 26701-26705 [2013-10895]

Download as PDF 26701 Rules and Regulations Federal Register Vol. 78, No. 89 Wednesday, May 8, 2013 This section of the FEDERAL REGISTER contains regulatory documents having general applicability and legal effect, most of which are keyed to and codified in the Code of Federal Regulations, which is published under 50 titles pursuant to 44 U.S.C. 1510. The Code of Federal Regulations is sold by the Superintendent of Documents. Prices of new books are listed in the first FEDERAL REGISTER issue of each week. 1. Remove the term ‘‘book’’ and add in its place, the term ‘‘market’’ on page 23453, in the first column, line 18. ■ § 615.5134 [Corrected] 2. On page 23456, in the first column, line 4, in § 615.5134(e), remove the term ‘‘book’’ and add in its place, the term ‘‘market’’. ■ Dated: May 1, 2013. Dale L. Aultman, Secretary, Farm Credit Administration Board. FARM CREDIT ADMINISTRATION [FR Doc. 2013–10820 Filed 5–7–13; 8:45 am] 12 CFR Part 615 BILLING CODE 6705–01–P RIN 3052–AC54 Funding and Fiscal Affairs, Loan Policies and Operations, and Funding Operations; Liquidity and Funding; Correction DEPARTMENT OF JUSTICE Farm Credit Administration. ACTION: Final rule; correction. [Docket No. DEA–369] AGENCY: The Farm Credit Administration (FCA) published a final rule in the Federal Register on April 18, 2013 to strengthen liquidity risk management at Farm Credit System (System) banks, improve the quality of assets in their liquidity reserves, and bolster the ability of System banks to fund their obligations and continue operations during times of economic, financial, or market adversity. This document corrects that rule by replacing a term that was inadvertently used. DATES: Effective Date: This regulation will be effective 30 days after publication in the Federal Register during which either or both Houses of Congress are in session. We will publish a notice of the effective date in the Federal Register. FOR FURTHER INFORMATION CONTACT: David Lewandrowski, Senior Policy Analyst, Office of Regulatory Policy, Farm Credit Administration, 1501 Farm Credit Drive, McLean, VA, (703) 883– 4498, TTY (703) 883–4056; or Richard A. Katz, Senior Counsel, Office of General Counsel, Farm Credit Administration, McLean, VA 22102– 5090, (703) 883–4020, TTY (703) 883– 4056. mstockstill on DSK4VPTVN1PROD with RULES SUMMARY: The FCA published a document in the Federal Register on April 18, 2013, (78 FR 23438) amending part 615. In FR Doc. 2013–09166, make the following corrections on two separate pages. SUPPLEMENTARY INFORMATION: VerDate Mar<15>2010 16:21 May 07, 2013 Jkt 229001 Drug Enforcement Administration 21 CFR Part 1308 Schedules of Controlled Substances: Placement of Lorcaserin Into Schedule IV Drug Enforcement Administration, Department of Justice. ACTION: Final rule. AGENCY: With the issuance of this final rule, the Administrator of the Drug Enforcement Administration (DEA) places the substance lorcaserin, including its salts, isomers and salts of isomers whenever the existence of such salts, isomers, and salts of isomers is possible, into Schedule IV of the Controlled Substances Act (CSA). This action is pursuant to the CSA which requires that such actions be made on the record after opportunity for a hearing through formal rulemaking. DATES: Effective Date: June 7, 2013. FOR FURTHER INFORMATION CONTACT: John W. Partridge, Executive Assistant, Office of Diversion Control, Drug Enforcement Administration; Mailing Address: 8701 Morrissette Drive, Springfield, Virginia 22152; Telephone, (202) 307–7165. SUPPLEMENTARY INFORMATION: SUMMARY: Legal Authority The DEA implements and enforces Titles II and III of the Comprehensive Drug Abuse Prevention and Control Act of 1970, often referred to as the Controlled Substances Act and the Controlled Substances Import and Export Act (21 U.S.C. 801–971), as amended (hereinafter, ‘‘CSA’’). The PO 00000 Frm 00001 Fmt 4700 Sfmt 4700 implementing regulations for these statutes are found in Title 21 of the Code of Federal Regulations (CFR), parts 1300 to 1321. Under the CSA, controlled substances are classified in one of five schedules based upon their potential for abuse, their currently accepted medical use, and the degree of dependence the substance may cause, 21 U.S.C. 812. The initial schedules of controlled substances by statute are found at 21 U.S.C. 812(c) and the current list of 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 subsection (b) of section 812 of this title for the schedule in which such drug is to be placed . . .’’ Pursuant to 28 CFR 0.100(b), the Attorney General has delegated this scheduling authority to the Administrator of DEA. 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 the Department of Health and Human Services (HHS),1 or (3) on the petition of any interested party. 21 U.S.C. 811(a). This action is based on a recommendation from the Assistant Secretary of HHS and on an evaluation of all other relevant data by DEA. This action imposes the regulatory controls and criminal sanctions of Schedule IV on the manufacture, distribution, dispensing, importation, and exportation of lorcaserin and products containing lorcaserin. Background Lorcaserin ((R)–8–chloro–1–methyl– 2,3,4,5–tetrahydro–1H–3–benzepine hydrochloride hemihydrate) is a new 1 As set forth in a memorandum of understanding entered into by HHS, the Food and Drug Administration, (FDA), and the National Institute on Drug Abuse (NIDA), FDA acts as the lead agency within HHS in carrying out the Secretary’s scheduling responsibilities under the CSA, with the concurrence of NIDA. 50 FR 9518. In addition, because the Secretary of HHS has delegated to the Assistant Secretary for Health of HHS the authority to make domestic drug scheduling recommendations, for purposes of this document, all subsequent references to ‘‘Secretary’’ have been replaced with ‘‘Assistant Secretary.’’ E:\FR\FM\08MYR1.SGM 08MYR1 26702 Federal Register / Vol. 78, No. 89 / Wednesday, May 8, 2013 / Rules and Regulations chemical entity which has central nervous system hallucinogenic properties. Lorcaserin is a serotonin receptor agonist, at the 5HT2C and 5HT2A receptor subtypes. Lorcaserin HCl was approved by the Food and Drug Administration (FDA) on June 27, 2012, as an addition to a reduced-calorie diet and exercise, for chronic weight management and it will be marketed under the trade name BELVIQ®. HHS and DEA Eight-Factor Analyses On June 25, 2012, the Department of Human Health Service (HHS) provided to the Drug Enforcement Administration (DEA) a scientific and medical evaluation and scheduling recommendation entitled ‘‘Basis for the Recommendation for Control of Lorcaserin in Schedule IV of the Controlled Substances Act.’’ Following consideration of the eight factors and findings related to the substance’s abuse potential, legitimate medical use, and dependence liability, HHS recommended that lorcaserin be controlled in Schedule IV of the CSA under 21 U.S.C. 812 (b). In response, DEA conducted an eightfactor analysis of abuse potential of lorcaserin pursuant to 21 U.S.C. 811(c). mstockstill on DSK4VPTVN1PROD with RULES Determination to Schedule Lorcaserin After a review of the available data, including the scientific and medical evaluation and the scheduling recommendation from HHS, the Administrator of the DEA published in the Federal Register a Notice of Proposed Rulemaking (NPRM) entitled, ‘‘Schedules of Controlled Substances: Placement of Lorcaserin into Schedule IV’’ on December 19, 2012 (77 FR 75075), which proposed placement of lorcaserin into Schedule IV of the CSA. The proposed rule provided an opportunity for all interested persons to submit their written comments on or before January 18, 2013. Comments Received DEA received seventy-one comments on the proposed rule to schedule lorcaserin. Commenters included individual health-care providers, national organizations, shareholders in the company which will market BELVIQ®, consultants, medical researchers, and other concerned citizens. There were 16 commenters in favor of the proposed rule and one opposed to it, with the remaining 54 commenters not taking a position. Support of the Proposed Rule Fifteen commenters supported controlling lorcaserin as a Schedule IV substance. Eleven commenters indicated VerDate Mar<15>2010 16:21 May 07, 2013 Jkt 229001 support for controlling lorcaserin under the CSA based on the abuse potential of the substance. Most of the commenters supported the proposal to control lorcaserin as a Schedule IV substance. Because lorcaserin will be indicated as a weight loss drug, some commenters mentioned that there will be a high demand for the drug by the general public upon the drug being marketed. According to the commenters, controlling lorcaserin as a Schedule IV substance will therefore provide the necessary controls to prevent its diversion. Two commenters mentioned that weight loss drugs are needed in the United States. DEA Response: DEA appreciates the support for this rulemaking. Opposition to the Proposed Rule Two commenters opposed the proposal to control lorcaserin as a Schedule IV substance. One commenter stated that lorcaserin should be controlled as a Schedule V substance, based on the commenter’s stance that DEA is making assumptions of the abuse potential of lorcaserin. The commenter indicated that DEA did not include the methodology used to determine the abuse potential of lorcaserin. The other commenter stated that lorcaserin should be a non-controlled substance based on data from a published study on the abuse potential of lorcaserin in recreational polydrug users.2 DEA Response: DEA does not agree. The studies used to assess abuse potential of lorcaserin are widely held as the standard methods of evaluation. Clinical studies indicated that lorcaserin, similar to comparator drugs zolpidem (Schedule IV) and ketamine (Schedule III) produced significant increases on positive subjective measures (VAS for ‘‘high’’ and ‘‘good drug effects’’) as well as an increase on the VAS for ‘‘hallucinations.’’ Lorcaserin, as well as zolpidem and ketamine, significantly increased reports of ‘‘sedation’’ on the subjective scale of the ARCI, compared to placebo. In a human abuse potential study, incidence of euphoria resulting from lorcaserin administration is similar to the incidence reported following zolpidem (Schedule IV) administration (13–16%) and lower than that following ketamine (Schedule III) administration (50%). The DEA did consider in its evaluation the published article 1 cited by the commenter. The data collectively suggest that lorcaserin does have sufficient abuse potential to warrant control under the CSA. HHS 2 Shram et al. (2011) Clin Pharmacol Ther; 89(5):683–92. PO 00000 Frm 00002 Fmt 4700 Sfmt 4700 recommended control of lorcaserin in Schedule IV of the CSA and the DEA’s placement findings support this level of control. Requests To Control Lorcaserin in a Higher Schedule Than Schedule IV Four commenters expressed concern that Schedule IV was not a stringent enough schedule for lorcaserin, based on it being an agonist at the 5–HT2A receptors. These commenters suggested that lorcaserin be controlled in Schedule II or Schedule III. 5–HT2A receptors mediate hallucinogenic properties of other drugs, such as lysergic acid diethylamide (LSD). DEA Response: DEA believes that placement in Schedule IV of the CSA will help restrict unsafe access to lorcaserin and reduce instances of its abuse. Upon receiving from HHS a scientific and medical evaluation and a scheduling recommendation for lorcaserin, DEA also conducted its own analysis of the eight factors in accordance with 21 U.S.C. 811(b). Based on the review of HHS’ evaluation and scheduling recommendation and other relevant data, DEA found that lorcaserin had a low potential for abuse relative to ketamine, a Schedule III drug, a currently accepted medical use for treatment in the United States, and that abuse of lorcaserin may lead to limited physical or psychological dependence relative to drugs in Schedule III. On the basis of these findings, lorcaserin is appropriately being controlled in Schedule IV. Requests To Expedite the Lorcaserin Scheduling Action There were thirty-two comments which requested that DEA expedite the scheduling action for lorcaserin. Generally, the commenters indicated that the scheduling action should be expedited due to epidemic levels of obesity in the United States and the absence of any weight loss drugs on the market with lorcaserin’s novel mechanism of action. Some commenters stated that the review conducted by FDA was sufficient to justify that lorcaserin be controlled expeditiously. Of these thirty-two comments, seven comments also requested that, ‘‘in the interest of public health,’’ DEA waive the 30-day comment or implementation period in order to make lorcaserin available immediately. One commenter stated that the scheduling action should be expedited because ‘‘based on scientific evidence that is available to date, there is no risk of this drug being addictive, and therefore abused.’’ From the previously mentioned thirty-two comments, eight comments E:\FR\FM\08MYR1.SGM 08MYR1 Federal Register / Vol. 78, No. 89 / Wednesday, May 8, 2013 / Rules and Regulations Risk Evaluations and Mitigation Strategy (REMS) Program for Lorcaserin Phentermine Being Combined With Lorcaserin mstockstill on DSK4VPTVN1PROD with RULES requested that the placement of lorcaserin in Schedule IV become effective on the date of the publication of the Final Rule. One commenter requested that the implementation period be limited to two weeks instead of the standard 30 days. Generally the commenters stated that since obesity and obesity-related illnesses are occurring at epidemic levels, lorcaserin should be available to health care practitioners and patients in the immediate future. One commenter referenced other scheduling actions in which the effective date was the same as the publication date of the Final Rule as justification of doing the same for the lorcaserin. The scheduling actions referenced were zopiclone (70 FR 16935), pregabalin (70 FR 43633), and ezogabine (76 FR 77895). DEA Response: DEA believes that providing 30 days for this rule to become effective is both expeditious and sufficient to allow handlers to apply for registration with DEA and to comply with regulatory requirements for handling Schedule IV controlled substances. With regard to the comment about lack of abuse potential for lorcaserin, as mentioned in both HHS’ and DEA’s scientific and medical analyses, the data collectively suggest that lorcaserin does have sufficient abuse potential and though the effective dates for scheduling zopiclone, pregabalin, and ezogabine were the date of publication of their respective Final Rule, DEA does not agree that lorcaserin’s effective date should be the date of publication of the Final Rule. The clinical indications of above referenced drugs are different from that of lorcaserin. DEA believes that the clinical indications for lorcaserin do not support the waiver of the 30-day period. With regard to the availability of weightloss drugs, DEA further notes that other weight-loss drugs are currently available on the market. The remaining comments were concerning various topics, not all of them being related to lorcaserin directly. The comments are summarized below as follows: Eight commenters expressed concern about the probability that healthcare providers would prescribe phentermine with lorcaserin to increase weight loss results in patients. DEA Response: Prescriptions for controlled substances, including lorcaserin, must be issued for a legitimate medical purpose by an individual practitioner acting in the usual course of professional practice. A determination of the validity of a prescription depends on an evaluation of the particular circumstances surrounding its issuance. VerDate Mar<15>2010 16:21 May 07, 2013 Jkt 229001 Three commenters stated that there should be a REMS program in place for the prescribing and dispensing of prescriptions of lorcaserin to minimize the misuse of lorcaserin. Two of these commenters also expressed concern about the effects of direct-to-consumer television advertisements of lorcaserin. DEA Response: FDA is responsible for determining whether REMS programs should be implemented for particular drugs. Various agencies, such as FDA and the Federal Trade Commission (FTC), have a role in regulating directto-consumer drug advertising. Request for a Hearing One commenter requested a formal hearing prior to the finalization of the scheduling action for lorcaserin. The commenter expressed concern that the potential for abuse of lorcaserin is large since the indication is for the drug to be taken chronically for weight loss. The commenter requested that the hearing include ‘‘relevant experts.’’ DEA Response: DEA regulations provide that ‘‘[a]ny interested person’’ may request a hearing on a proposed scheduling action. 21 CFR 1308.44(a). DEA regulations define ‘‘interested person’’ as ‘‘any person adversely affected or aggrieved by any rule or proposed rule issuable pursuant to [21 U.S.C. 811].’’ 21 CFR 1300.01(b). The regulations further require that any person requesting a hearing must state ‘‘with particularity’’ his interest in the proceeding. 21 CFR 1316.47(a). Because the commenter failed to provide sufficient information to demonstrate that he meets the definition of ‘‘interested person’’ as set forth in the regulations, DEA hereby denies this hearing request. Other Comments • Several commenters were critical of DEA’s handling of the scheduling process. The commenters did not provide specific recommendations for action. • One commenter expressed concern about the abuse potential of lorcaserin. The commenter did not indicate whether they opposed or supported the proposal to control lorcaserin. • One commenter requested that DEA extend the comment period for the NPRM by 60 additional days. The commenter indicated that the public had not been given sufficient time to respond to the NPRM. DEA has PO 00000 Frm 00003 Fmt 4700 Sfmt 4700 26703 allowed 30 days for a comment period in previous scheduling actions for new chemical entities. A 30-day comment period has been demonstrated to be a sufficient period to allow the public to submit comments to proposed scheduling actions. • One commenter submitted information about Combo Pilling, which is not related to the current control action. • One commenter discussed the side effects experienced with taking Qsymia, a weight loss drug. This comment was not related to the current scheduling action. • Two commenters stated that obesity drugs are not needed to deal with the current obesity epidemic. This comment was not related to the current scheduling action. Scheduling Conclusion Based on consideration of all comments, the scientific and medical evaluation and accompanying recommendation of HHS, and based on DEA’s consideration of its own eightfactor analysis, DEA finds that these facts and all relevant data constitute substantial evidence of potential for abuse of lorcaserin. As such, DEA will schedule lorcaserin 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 statute 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 HHS and review of all available data, the Administrator of DEA, pursuant to 21 U.S.C. 812(b)(4), finds that: (1) Lorcaserin has a low potential for abuse relative to the drugs or other substances in Schedule III. The overall abuse potential of lorcaserin is comparable to Schedule IV substances such as zolpidem; (2) Lorcaserin has a currently accepted medical use in treatment in the United States. Lorcaserin HCL was approved for marketing by FDA as an addition to a reduced-calorie diet and exercise, for chronic weight management; and (3) Abuse of lorcaserin may lead to limited physical dependence or psychological dependence relative to the drugs or other substances in Schedule III. This finding is based on the ability of lorcaserin to produce positive subjective effects at supratherapeutic doses. Based on these findings, the Administrator of DEA concludes that lorcaserin, including its salts, isomers, and salts of isomers whenever the existence of such salts, isomers, and salts of isomers is possible, warrants E:\FR\FM\08MYR1.SGM 08MYR1 26704 Federal Register / Vol. 78, No. 89 / Wednesday, May 8, 2013 / Rules and Regulations control in Schedule IV of the CSA (21 U.S.C. 812(b)(4)). mstockstill on DSK4VPTVN1PROD with RULES Requirements for Handling Lorcaserin Upon the effective date of this final rule, lorcaserin is subject to the CSA and the Controlled Substances Import and Export Act (CSIEA) regulatory controls and administrative, civil, and criminal sanctions applicable to the manufacture, distribution, dispensing, importing, and exporting of a Schedule IV controlled substance, including the following: Registration. Any person who manufactures, distributes, dispenses, imports, exports, engages in research or conducts instructional activities with lorcaserin, or who desires to manufacture, distribute, dispense, import, export, engage in research or conduct instructional activities with lorcaserin, must be registered to conduct such activities pursuant to 21 U.S.C. 822 and in accordance with 21 CFR Part 1301. Any person who is currently engaged in any of the above activities and is not registered with DEA must submit an application for registration on or before June 7, 2013 and may not continue their activities until DEA has approved that application. Security. Lorcaserin is subject to Schedules III–V security requirements and must be manufactured, distributed, and stored pursuant to 21 U.S.C. 823 and in accordance with 21 CFR 1301.71, 1301.72(b), (c), and (d), 1301.73, 1301.74, 1301.75(b) and (c), 1301.76, and 1301.77 on or after June 7, 2013. Labeling and Packaging. All labels and labeling for commercial containers of lorcaserin must be in accordance with 21 CFR 1302.03–1302.07, pursuant to 21 U.S.C. 825, on or after June 7, 2013. Inventory. Every registrant required to keep records and who possesses any quantity of lorcaserin must keep an inventory of all stocks of lorcaserin on hand pursuant to 21 U.S.C. 827 and in accordance with 21 CFR 1304.03, 1304.04, 1304.06, and 1304.11 on or after June 7, 2013. Every registrant who desires registration in Schedule IV for lorcaserin is required to conduct an inventory of all stocks of the substance on hand at the time of registration. Records. All registrants must keep records pursuant to 21 U.S.C. 827 and in accordance with 21 CFR 1304.03, 1304.04, 1304.21, 1304.22, and 1304.23 on or after June 7, 2013. Prescriptions. All prescriptions for lorcaserin or prescriptions for products containing lorcaserin must comply with 21 U.S.C. 829 and 21 CFR 1306, including but not limited to 21 CFR 1306.03–1306.06, 1306.08, 1306.09, and VerDate Mar<15>2010 16:21 May 07, 2013 Jkt 229001 1306.21–1306.27 on or after June 7, 2013. Importation and Exportation. All importation and exportation of lorcaserin must be done in accordance with 21 CFR Part 1312, pursuant to 21 U.S.C. 952, 953, 957, and 958, on or after June 7, 2013. Criminal Liability. Any activity with lorcaserin not authorized by, or in violation of, the Controlled Substances Act or the Controlled Substances Import and Export Act shall be unlawful on or after June 7, 2013. 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 Administrator, in accordance with the Regulatory Flexibility Act (5 U.S.C. 601–612) (RFA), has reviewed PO 00000 Frm 00004 Fmt 4700 Sfmt 4700 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 lorcaserin, including its salts, isomers and salts of isomers, into Schedule IV of the CSA. By this final rule, lorcaserin will remain in Schedule IV unless and until additional scheduling action is taken to either transfer it between the schedules or to remove it from the list of schedules. See 21 U.S.C. 811 and 812. No less restrictive measures (i.e., noncontrol) enable DEA to meet its statutory obligations under the CSA. Lorcaserin is a new chemical entity and is not currently available or marketed in any country. According to publicly available information reviewed by DEA, lorcaserin is anticipated to enjoy patent protection for at least a decade before generic equivalents may be manufactured and marketed. Accordingly, the number of currently identifiable manufacturers, importers, and distributors for lorcaserin 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, the lorcaserin manufacturer was identified as a small entity and is expected to conduct manufacturing activities at a facility outside the United States; the distributor/importer does not meet the standard as a small entity. Once generic equivalents are developed and approved for manufacturing and marketing, there may be additional manufacturers, importers, and distributors of lorcaserin, but whether they may qualify as small entity cannot be determined at this time. There are approximately 1.4 million controlled substance registrants, approximately 381,000 of which are estimated to be businesses. DEA estimates that 371,000 (97%) of these businesses are considered ‘‘small entities’’ in accordance with the RFA and Small Business Administration standards. 5 U.S.C. 601(6) and 15 U.S.C. 632. However, due to the wide variety of unidentifiable and unquantifiable variables that potentially could influence the dispensing rates of new chemical entities, DEA is unable to determine the number of small entities which might dispense (including administer or prescribe) lorcaserin (e.g., pharmacies and prescribers). Despite the fact that the number of small businesses possibly impacted by this rule could not be determined, DEA concludes that they would not experience a significant economic impact as a result of this rule. Currently E:\FR\FM\08MYR1.SGM 08MYR1 Federal Register / Vol. 78, No. 89 / Wednesday, May 8, 2013 / Rules and Regulations governments, in the aggregate, or by the private sector, of $100,000,000 or more (adjusted for inflation) in any one year. Therefore, no actions were deemed necessary under provisions of the Unfunded Mandates Reform Act of 1995 (UMRA). Unfunded Mandates Reform Act of 1995 For the reasons stated in the above section titled, ‘‘Regulatory Flexibility Act,’’ 3 this rule does not include a Federal mandate that may result in the expenditure by state, local, and tribal mstockstill on DSK4VPTVN1PROD with RULES 98% of DEA registrants (most of which are small businesses) are authorized to handle Schedule IV controlled substances. Even if we assume that all of these registrants were to handle lorcaserin (e.g., practitioners prescribe the substance, and pharmacies dispense those prescriptions), the costs that they would incur as a result of lorcaserin’s scheduling would be nominal. Registrants that dispense (but not prescribe) would incur nominal additional security, inventory, recordkeeping, and labeling costs. These registered entities have already established and implemented these systems and processes required to handle Schedule IV controlled substances, and can easily absorb the costs of dispensing lorcaserin with nominal to no additional economic burden. For example, pharmacies and institutional practitioners may disperse Schedule II through V controlled substances throughout the stock of noncontrolled substances in such a manner as to obstruct theft or diversion of the controlled substances. In addition, because registered pharmacies must label all Schedule II through V controlled substances that they dispense, the requirement to label all dispensed substances containing lorcaserin would not impose a significant economic burden upon registered pharmacies. Accordingly, compliance would not require significant additional manpower, capital investment, or recordkeeping burdens. The only additional requirement imposed by this rule upon registrants that only prescribe substances containing lorcaserin is that they issue an oral or written prescription to dispense the substance. Accordingly, registered prescribers would not incur any additional security, inventory, recordkeeping, or labeling costs as a result of this rule as they would not physically handle lorcaserin. Because of these facts, this rule will not result in a significant economic impact on a substantial number of small entities. Authority: 21 U.S.C. 811, 812, 871(b), unless otherwise noted. 3 UMRA and the RFA share the same definition of ‘‘rule.’’ UMRA defines ‘‘regulation’’ or ‘‘rule’’ by cross-referencing the RFA’s definition of ‘‘rule.’’ 2 U.S.C. 658(10)). The RFA generally defines ‘‘rule’’ as ‘‘any rule for which the agency publishes a general notice of proposed rulemaking pursuant to section 553(b) of [the Administrative Procedure Act].’’ 5 U.S.C. 601(2). VerDate Mar<15>2010 16:21 May 07, 2013 Jkt 229001 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. Congressional Review Act This rule is not a major rule as defined by § 804 of the Small Business Regulatory Enforcement Fairness Act of 1996 (Congressional Review Act). 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, 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. Under the authority vested in the Attorney General by Section 201(a) of the CSA (21 U.S.C. 811(a)), and delegated to the Administrator of DEA by Department of Justice regulations (28 CFR 0.100) the Administrator hereby amends 21 CFR part 1308 as follows: PART 1308—SCHEDULES OF CONTROLLED SUBSTANCES The authority citation for 21 CFR Part 1308 continues to read as follows: 1. Section 1308.14 is amended by redesignating paragraphs (e) and (f) as paragraphs (f) and (g), and adding a new paragraph (e) to read as follows: ■ § 1308.14 Schedule IV. * * * * * (e) Lorcaserin. Any material, compound, mixture, or preparation which contains any quantity of the following substances, including its salts, isomers, and salts of such isomers, PO 00000 Frm 00005 Fmt 4700 Sfmt 4700 26705 whenever the existence of such salts, isomers, and salts of isomers is possible: (1) Lorcaserin ................................... * * * * 1625 * Dated: April 29, 2013. Michele M. Leonhart, Administrator. [FR Doc. 2013–10895 Filed 5–7–13; 8:45 am] BILLING CODE 4410–09–P FEDERAL COMMUNICATIONS COMMISSION 47 CFR Part 54 [WC Docket Nos. 09–197; 11–42; FCC 13– 44] Telecommunications Carriers Eligible for Support; Lifeline and Link Up Reform and Several Petitions for Forbearance Federal Communications Commission. ACTION: Final rule. AGENCY: In this order, the Federal Communications Commission (Commission) grants limited forbearance from the requirement of the Commission’s rules that the service area of an eligible telecommunications carrier (ETC) conform to the service area of any rural telephone company serving the same area. In particular, this grant of forbearance applies to any ETC that has been designated by a state or the Commission, as well as pending and future requests by telecommunications carriers that seek limited designation, as an ETC to participate only in the Lifeline program (Lifeline-only ETC). The Commission concludes that forbearance furthers the Act’s and Commission’s goals of ensuring the availability of voice service to lowincome consumers. DATES: Effective June 7, 2013, except paragraph 19 which is effective upon release of the Memorandum Opinion and Order. FOR FURTHER INFORMATION CONTACT: Alexander Minard, Wireline Competition Bureau, (202) 418–0428 or TTY: (202) 418–0484. SUPPLEMENTARY INFORMATION: This is a summary of the Commission’s Memorandum Opinion and Order (Order) in WC Docket Nos. 09–197;11– 42; FCC 13–44, released on April 15, 2013. The full text of this document is available for public inspection during regular business hours in the FCC Reference Center, Room CY–A257, 445 12th Street SW., Washington, DC 20554. Or at the following Internet address: SUMMARY: E:\FR\FM\08MYR1.SGM 08MYR1

Agencies

[Federal Register Volume 78, Number 89 (Wednesday, May 8, 2013)]
[Rules and Regulations]
[Pages 26701-26705]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: 2013-10895]


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DEPARTMENT OF JUSTICE

Drug Enforcement Administration

21 CFR Part 1308

[Docket No. DEA-369]


Schedules of Controlled Substances: Placement of Lorcaserin 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 Administrator of the 
Drug Enforcement Administration (DEA) places the substance lorcaserin, 
including its salts, isomers and salts of isomers whenever the 
existence of such salts, isomers, and salts of isomers is possible, 
into Schedule IV of the Controlled Substances Act (CSA). This action is 
pursuant to the CSA which requires that such actions be made on the 
record after opportunity for a hearing through formal rulemaking.

DATES: Effective Date: June 7, 2013.

FOR FURTHER INFORMATION CONTACT: John W. Partridge, Executive 
Assistant, Office of Diversion Control, Drug Enforcement 
Administration; Mailing Address: 8701 Morrissette Drive, Springfield, 
Virginia 22152; Telephone, (202) 307-7165.

SUPPLEMENTARY INFORMATION: 

Legal Authority

    The DEA implements and enforces Titles II and III of the 
Comprehensive Drug Abuse Prevention and Control Act of 1970, often 
referred to as the Controlled Substances Act and the Controlled 
Substances Import and Export Act (21 U.S.C. 801-971), as amended 
(hereinafter, ``CSA''). The implementing regulations for these statutes 
are found in Title 21 of the Code of Federal Regulations (CFR), parts 
1300 to 1321. Under the CSA, controlled substances are classified in 
one of five schedules based upon their potential for abuse, their 
currently accepted medical use, and the degree of dependence the 
substance may cause, 21 U.S.C. 812. The initial schedules of controlled 
substances by statute are found at 21 U.S.C. 812(c) and the current 
list of 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 subsection (b) of section 812 of 
this title for the schedule in which such drug is to be placed . . .'' 
Pursuant to 28 CFR 0.100(b), the Attorney General has delegated this 
scheduling authority to the Administrator of DEA.
    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 the Department of Health and Human Services 
(HHS),\1\ or (3) on the petition of any interested party. 21 U.S.C. 
811(a). This action is based on a recommendation from the Assistant 
Secretary of HHS and on an evaluation of all other relevant data by 
DEA. This action imposes the regulatory controls and criminal sanctions 
of Schedule IV on the manufacture, distribution, dispensing, 
importation, and exportation of lorcaserin and products containing 
lorcaserin.
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    \1\ As set forth in a memorandum of understanding entered into 
by HHS, the Food and Drug Administration, (FDA), and the National 
Institute on Drug Abuse (NIDA), FDA acts as the lead agency within 
HHS in carrying out the Secretary's scheduling responsibilities 
under the CSA, with the concurrence of NIDA. 50 FR 9518. In 
addition, because the Secretary of HHS has delegated to the 
Assistant Secretary for Health of HHS the authority to make domestic 
drug scheduling recommendations, for purposes of this document, all 
subsequent references to ``Secretary'' have been replaced with 
``Assistant Secretary.''
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Background

    Lorcaserin ((R)-8-chloro-1-methyl-2,3,4,5-tetrahydro-1H-3-benzepine 
hydrochloride hemihydrate) is a new

[[Page 26702]]

chemical entity which has central nervous system hallucinogenic 
properties. Lorcaserin is a serotonin receptor agonist, at the 
5HT2C and 5HT2A receptor subtypes. Lorcaserin HCl 
was approved by the Food and Drug Administration (FDA) on June 27, 
2012, as an addition to a reduced-calorie diet and exercise, for 
chronic weight management and it will be marketed under the trade name 
BELVIQ[supreg].

HHS and DEA Eight-Factor Analyses

    On June 25, 2012, the Department of Human Health Service (HHS) 
provided to the Drug Enforcement Administration (DEA) a scientific and 
medical evaluation and scheduling recommendation entitled ``Basis for 
the Recommendation for Control of Lorcaserin in Schedule IV of the 
Controlled Substances Act.'' Following consideration of the eight 
factors and findings related to the substance's abuse potential, 
legitimate medical use, and dependence liability, HHS recommended that 
lorcaserin be controlled in Schedule IV of the CSA under 21 U.S.C. 812 
(b).
    In response, DEA conducted an eight-factor analysis of abuse 
potential of lorcaserin pursuant to 21 U.S.C. 811(c).

Determination to Schedule Lorcaserin

    After a review of the available data, including the scientific and 
medical evaluation and the scheduling recommendation from HHS, the 
Administrator of the DEA published in the Federal Register a Notice of 
Proposed Rulemaking (NPRM) entitled, ``Schedules of Controlled 
Substances: Placement of Lorcaserin into Schedule IV'' on December 19, 
2012 (77 FR 75075), which proposed placement of lorcaserin into 
Schedule IV of the CSA. The proposed rule provided an opportunity for 
all interested persons to submit their written comments on or before 
January 18, 2013.

Comments Received

    DEA received seventy-one comments on the proposed rule to schedule 
lorcaserin. Commenters included individual health-care providers, 
national organizations, shareholders in the company which will market 
BELVIQ[supreg], consultants, medical researchers, and other concerned 
citizens. There were 16 commenters in favor of the proposed rule and 
one opposed to it, with the remaining 54 commenters not taking a 
position.

Support of the Proposed Rule

    Fifteen commenters supported controlling lorcaserin as a Schedule 
IV substance. Eleven commenters indicated support for controlling 
lorcaserin under the CSA based on the abuse potential of the substance. 
Most of the commenters supported the proposal to control lorcaserin as 
a Schedule IV substance. Because lorcaserin will be indicated as a 
weight loss drug, some commenters mentioned that there will be a high 
demand for the drug by the general public upon the drug being marketed. 
According to the commenters, controlling lorcaserin as a Schedule IV 
substance will therefore provide the necessary controls to prevent its 
diversion. Two commenters mentioned that weight loss drugs are needed 
in the United States.
    DEA Response: DEA appreciates the support for this rulemaking.

Opposition to the Proposed Rule

    Two commenters opposed the proposal to control lorcaserin as a 
Schedule IV substance. One commenter stated that lorcaserin should be 
controlled as a Schedule V substance, based on the commenter's stance 
that DEA is making assumptions of the abuse potential of lorcaserin. 
The commenter indicated that DEA did not include the methodology used 
to determine the abuse potential of lorcaserin. The other commenter 
stated that lorcaserin should be a non-controlled substance based on 
data from a published study on the abuse potential of lorcaserin in 
recreational polydrug users.\2\
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    \2\ Shram et al. (2011) Clin Pharmacol Ther; 89(5):683-92.
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    DEA Response: DEA does not agree. The studies used to assess abuse 
potential of lorcaserin are widely held as the standard methods of 
evaluation. Clinical studies indicated that lorcaserin, similar to 
comparator drugs zolpidem (Schedule IV) and ketamine (Schedule III) 
produced significant increases on positive subjective measures (VAS for 
``high'' and ``good drug effects'') as well as an increase on the VAS 
for ``hallucinations.'' Lorcaserin, as well as zolpidem and ketamine, 
significantly increased reports of ``sedation'' on the subjective scale 
of the ARCI, compared to placebo. In a human abuse potential study, 
incidence of euphoria resulting from lorcaserin administration is 
similar to the incidence reported following zolpidem (Schedule IV) 
administration (13-16%) and lower than that following ketamine 
(Schedule III) administration (50%). The DEA did consider in its 
evaluation the published article \1\ cited by the commenter. The data 
collectively suggest that lorcaserin does have sufficient abuse 
potential to warrant control under the CSA. HHS recommended control of 
lorcaserin in Schedule IV of the CSA and the DEA's placement findings 
support this level of control.

Requests To Control Lorcaserin in a Higher Schedule Than Schedule IV

    Four commenters expressed concern that Schedule IV was not a 
stringent enough schedule for lorcaserin, based on it being an agonist 
at the 5-HT2A receptors. These commenters suggested that 
lorcaserin be controlled in Schedule II or Schedule III. 5-
HT2A receptors mediate hallucinogenic properties of other 
drugs, such as lysergic acid diethylamide (LSD).
    DEA Response: DEA believes that placement in Schedule IV of the CSA 
will help restrict unsafe access to lorcaserin and reduce instances of 
its abuse. Upon receiving from HHS a scientific and medical evaluation 
and a scheduling recommendation for lorcaserin, DEA also conducted its 
own analysis of the eight factors in accordance with 21 U.S.C. 811(b). 
Based on the review of HHS' evaluation and scheduling recommendation 
and other relevant data, DEA found that lorcaserin had a low potential 
for abuse relative to ketamine, a Schedule III drug, a currently 
accepted medical use for treatment in the United States, and that abuse 
of lorcaserin may lead to limited physical or psychological dependence 
relative to drugs in Schedule III. On the basis of these findings, 
lorcaserin is appropriately being controlled in Schedule IV.

Requests To Expedite the Lorcaserin Scheduling Action

    There were thirty-two comments which requested that DEA expedite 
the scheduling action for lorcaserin. Generally, the commenters 
indicated that the scheduling action should be expedited due to 
epidemic levels of obesity in the United States and the absence of any 
weight loss drugs on the market with lorcaserin's novel mechanism of 
action. Some commenters stated that the review conducted by FDA was 
sufficient to justify that lorcaserin be controlled expeditiously. Of 
these thirty-two comments, seven comments also requested that, ``in the 
interest of public health,'' DEA waive the 30-day comment or 
implementation period in order to make lorcaserin available 
immediately. One commenter stated that the scheduling action should be 
expedited because ``based on scientific evidence that is available to 
date, there is no risk of this drug being addictive, and therefore 
abused.''
    From the previously mentioned thirty-two comments, eight comments

[[Page 26703]]

requested that the placement of lorcaserin in Schedule IV become 
effective on the date of the publication of the Final Rule. One 
commenter requested that the implementation period be limited to two 
weeks instead of the standard 30 days. Generally the commenters stated 
that since obesity and obesity-related illnesses are occurring at 
epidemic levels, lorcaserin should be available to health care 
practitioners and patients in the immediate future. One commenter 
referenced other scheduling actions in which the effective date was the 
same as the publication date of the Final Rule as justification of 
doing the same for the lorcaserin. The scheduling actions referenced 
were zopiclone (70 FR 16935), pregabalin (70 FR 43633), and ezogabine 
(76 FR 77895).
    DEA Response: DEA believes that providing 30 days for this rule to 
become effective is both expeditious and sufficient to allow handlers 
to apply for registration with DEA and to comply with regulatory 
requirements for handling Schedule IV controlled substances. With 
regard to the comment about lack of abuse potential for lorcaserin, as 
mentioned in both HHS' and DEA's scientific and medical analyses, the 
data collectively suggest that lorcaserin does have sufficient abuse 
potential and though the effective dates for scheduling zopiclone, 
pregabalin, and ezogabine were the date of publication of their 
respective Final Rule, DEA does not agree that lorcaserin's effective 
date should be the date of publication of the Final Rule. The clinical 
indications of above referenced drugs are different from that of 
lorcaserin. DEA believes that the clinical indications for lorcaserin 
do not support the waiver of the 30-day period. With regard to the 
availability of weight-loss drugs, DEA further notes that other weight-
loss drugs are currently available on the market.

Phentermine Being Combined With Lorcaserin

    Eight commenters expressed concern about the probability that 
healthcare providers would prescribe phentermine with lorcaserin to 
increase weight loss results in patients.
    DEA Response: Prescriptions for controlled substances, including 
lorcaserin, must be issued for a legitimate medical purpose by an 
individual practitioner acting in the usual course of professional 
practice. A determination of the validity of a prescription depends on 
an evaluation of the particular circumstances surrounding its issuance.

Risk Evaluations and Mitigation Strategy (REMS) Program for Lorcaserin

    Three commenters stated that there should be a REMS program in 
place for the prescribing and dispensing of prescriptions of lorcaserin 
to minimize the misuse of lorcaserin. Two of these commenters also 
expressed concern about the effects of direct-to-consumer television 
advertisements of lorcaserin.
    DEA Response: FDA is responsible for determining whether REMS 
programs should be implemented for particular drugs. Various agencies, 
such as FDA and the Federal Trade Commission (FTC), have a role in 
regulating direct-to-consumer drug advertising.

Request for a Hearing

    One commenter requested a formal hearing prior to the finalization 
of the scheduling action for lorcaserin. The commenter expressed 
concern that the potential for abuse of lorcaserin is large since the 
indication is for the drug to be taken chronically for weight loss. The 
commenter requested that the hearing include ``relevant experts.''
    DEA Response: DEA regulations provide that ``[a]ny interested 
person'' may request a hearing on a proposed scheduling action. 21 CFR 
1308.44(a). DEA regulations define ``interested person'' as ``any 
person adversely affected or aggrieved by any rule or proposed rule 
issuable pursuant to [21 U.S.C. 811].'' 21 CFR 1300.01(b). The 
regulations further require that any person requesting a hearing must 
state ``with particularity'' his interest in the proceeding. 21 CFR 
1316.47(a). Because the commenter failed to provide sufficient 
information to demonstrate that he meets the definition of ``interested 
person'' as set forth in the regulations, DEA hereby denies this 
hearing request.

Other Comments

    The remaining comments were concerning various topics, not all of 
them being related to lorcaserin directly. The comments are summarized 
below as follows:

     Several commenters were critical of DEA's handling of 
the scheduling process. The commenters did not provide specific 
recommendations for action.
     One commenter expressed concern about the abuse 
potential of lorcaserin. The commenter did not indicate whether they 
opposed or supported the proposal to control lorcaserin.
     One commenter requested that DEA extend the comment 
period for the NPRM by 60 additional days. The commenter indicated 
that the public had not been given sufficient time to respond to the 
NPRM. DEA has allowed 30 days for a comment period in previous 
scheduling actions for new chemical entities. A 30-day comment 
period has been demonstrated to be a sufficient period to allow the 
public to submit comments to proposed scheduling actions.
     One commenter submitted information about Combo 
Pilling, which is not related to the current control action.
     One commenter discussed the side effects experienced 
with taking Qsymia, a weight loss drug. This comment was not related 
to the current scheduling action.
     Two commenters stated that obesity drugs are not needed 
to deal with the current obesity epidemic. This comment was not 
related to the current scheduling action.

Scheduling Conclusion

    Based on consideration of all comments, the scientific and medical 
evaluation and accompanying recommendation of HHS, and based on DEA's 
consideration of its own eight-factor analysis, DEA finds that these 
facts and all relevant data constitute substantial evidence of 
potential for abuse of lorcaserin. As such, DEA will schedule 
lorcaserin 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 statute 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 HHS and review 
of all available data, the Administrator of DEA, pursuant to 21 U.S.C. 
812(b)(4), finds that:
    (1) Lorcaserin has a low potential for abuse relative to the drugs 
or other substances in Schedule III. The overall abuse potential of 
lorcaserin is comparable to Schedule IV substances such as zolpidem;
    (2) Lorcaserin has a currently accepted medical use in treatment in 
the United States. Lorcaserin HCL was approved for marketing by FDA as 
an addition to a reduced-calorie diet and exercise, for chronic weight 
management; and
    (3) Abuse of lorcaserin may lead to limited physical dependence or 
psychological dependence relative to the drugs or other substances in 
Schedule III. This finding is based on the ability of lorcaserin to 
produce positive subjective effects at supratherapeutic doses.
    Based on these findings, the Administrator of DEA concludes that 
lorcaserin, including its salts, isomers, and salts of isomers whenever 
the existence of such salts, isomers, and salts of isomers is possible, 
warrants

[[Page 26704]]

control in Schedule IV of the CSA (21 U.S.C. 812(b)(4)).

Requirements for Handling Lorcaserin

    Upon the effective date of this final rule, lorcaserin is subject 
to the CSA and the Controlled Substances Import and Export Act (CSIEA) 
regulatory controls and administrative, civil, and criminal sanctions 
applicable to the manufacture, distribution, dispensing, importing, and 
exporting of a Schedule IV controlled substance, including the 
following:
    Registration. Any person who manufactures, distributes, dispenses, 
imports, exports, engages in research or conducts instructional 
activities with lorcaserin, or who desires to manufacture, distribute, 
dispense, import, export, engage in research or conduct instructional 
activities with lorcaserin, must be registered to conduct such 
activities pursuant to 21 U.S.C. 822 and in accordance with 21 CFR Part 
1301. Any person who is currently engaged in any of the above 
activities and is not registered with DEA must submit an application 
for registration on or before June 7, 2013 and may not continue their 
activities until DEA has approved that application.
    Security. Lorcaserin is subject to Schedules III-V security 
requirements and must be manufactured, distributed, and stored pursuant 
to 21 U.S.C. 823 and in accordance with 21 CFR 1301.71, 1301.72(b), 
(c), and (d), 1301.73, 1301.74, 1301.75(b) and (c), 1301.76, and 
1301.77 on or after June 7, 2013.
    Labeling and Packaging. All labels and labeling for commercial 
containers of lorcaserin must be in accordance with 21 CFR 1302.03-
1302.07, pursuant to 21 U.S.C. 825, on or after June 7, 2013.
    Inventory. Every registrant required to keep records and who 
possesses any quantity of lorcaserin must keep an inventory of all 
stocks of lorcaserin on hand pursuant to 21 U.S.C. 827 and in 
accordance with 21 CFR 1304.03, 1304.04, 1304.06, and 1304.11 on or 
after June 7, 2013. Every registrant who desires registration in 
Schedule IV for lorcaserin is required to conduct an inventory of all 
stocks of the substance on hand at the time of registration.
    Records. All registrants must keep records pursuant to 21 U.S.C. 
827 and in accordance with 21 CFR 1304.03, 1304.04, 1304.21, 1304.22, 
and 1304.23 on or after June 7, 2013.
    Prescriptions. All prescriptions for lorcaserin or prescriptions 
for products containing lorcaserin must comply with 21 U.S.C. 829 and 
21 CFR 1306, including but not limited to 21 CFR 1306.03-1306.06, 
1306.08, 1306.09, and 1306.21-1306.27 on or after June 7, 2013.
    Importation and Exportation. All importation and exportation of 
lorcaserin must be done in accordance with 21 CFR Part 1312, pursuant 
to 21 U.S.C. 952, 953, 957, and 958, on or after June 7, 2013.
    Criminal Liability. Any activity with lorcaserin not authorized by, 
or in violation of, the Controlled Substances Act or the Controlled 
Substances Import and Export Act shall be unlawful on or after June 7, 
2013.

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 Administrator, in accordance with the Regulatory Flexibility 
Act (5 U.S.C. 601-612) (RFA), 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 lorcaserin, including its salts, isomers and 
salts of isomers, into Schedule IV of the CSA. By this final rule, 
lorcaserin will remain in Schedule IV unless and until additional 
scheduling action is taken to either transfer it between the schedules 
or to remove it from the list of schedules. See 21 U.S.C. 811 and 812. 
No less restrictive measures (i.e., non-control) enable DEA to meet its 
statutory obligations under the CSA.
    Lorcaserin is a new chemical entity and is not currently available 
or marketed in any country. According to publicly available information 
reviewed by DEA, lorcaserin is anticipated to enjoy patent protection 
for at least a decade before generic equivalents may be manufactured 
and marketed. Accordingly, the number of currently identifiable 
manufacturers, importers, and distributors for lorcaserin 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, the 
lorcaserin manufacturer was identified as a small entity and is 
expected to conduct manufacturing activities at a facility outside the 
United States; the distributor/importer does not meet the standard as a 
small entity. Once generic equivalents are developed and approved for 
manufacturing and marketing, there may be additional manufacturers, 
importers, and distributors of lorcaserin, but whether they may qualify 
as small entity cannot be determined at this time.
    There are approximately 1.4 million controlled substance 
registrants, approximately 381,000 of which are estimated to be 
businesses. DEA estimates that 371,000 (97%) of these businesses are 
considered ``small entities'' in accordance with the RFA and Small 
Business Administration standards. 5 U.S.C. 601(6) and 15 U.S.C. 632. 
However, due to the wide variety of unidentifiable and unquantifiable 
variables that potentially could influence the dispensing rates of new 
chemical entities, DEA is unable to determine the number of small 
entities which might dispense (including administer or prescribe) 
lorcaserin (e.g., pharmacies and prescribers).
    Despite the fact that the number of small businesses possibly 
impacted by this rule could not be determined, DEA concludes that they 
would not experience a significant economic impact as a result of this 
rule. Currently

[[Page 26705]]

98% of DEA registrants (most of which are small businesses) are 
authorized to handle Schedule IV controlled substances. Even if we 
assume that all of these registrants were to handle lorcaserin (e.g., 
practitioners prescribe the substance, and pharmacies dispense those 
prescriptions), the costs that they would incur as a result of 
lorcaserin's scheduling would be nominal. Registrants that dispense 
(but not prescribe) would incur nominal additional security, inventory, 
recordkeeping, and labeling costs. These registered entities have 
already established and implemented these systems and processes 
required to handle Schedule IV controlled substances, and can easily 
absorb the costs of dispensing lorcaserin with nominal to no additional 
economic burden. For example, pharmacies and institutional 
practitioners may disperse Schedule II through V controlled substances 
throughout the stock of noncontrolled substances in such a manner as to 
obstruct theft or diversion of the controlled substances. In addition, 
because registered pharmacies must label all Schedule II through V 
controlled substances that they dispense, the requirement to label all 
dispensed substances containing lorcaserin would not impose a 
significant economic burden upon registered pharmacies. Accordingly, 
compliance would not require significant additional manpower, capital 
investment, or recordkeeping burdens.
    The only additional requirement imposed by this rule upon 
registrants that only prescribe substances containing lorcaserin is 
that they issue an oral or written prescription to dispense the 
substance. Accordingly, registered prescribers would not incur any 
additional security, inventory, recordkeeping, or labeling costs as a 
result of this rule as they would not physically handle lorcaserin.
    Because of these facts, this rule will not result in a significant 
economic impact on a substantial number of small entities.

Unfunded Mandates Reform Act of 1995

    For the reasons stated in the above section titled, ``Regulatory 
Flexibility Act,'' \3\ this rule does not include a 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, no actions were deemed necessary under provisions of the 
Unfunded Mandates Reform Act of 1995 (UMRA).
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    \3\ UMRA and the RFA share the same definition of ``rule.'' UMRA 
defines ``regulation'' or ``rule'' by cross-referencing the RFA's 
definition of ``rule.'' 2 U.S.C. 658(10)). The RFA generally defines 
``rule'' as ``any rule for which the agency publishes a general 
notice of proposed rulemaking pursuant to section 553(b) of [the 
Administrative Procedure Act].'' 5 U.S.C. 601(2).
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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.

Congressional Review Act

    This rule is not a major rule as defined by Sec.  804 of the Small 
Business Regulatory Enforcement Fairness Act of 1996 (Congressional 
Review Act). 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, 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.

    Under the authority vested in the Attorney General by Section 
201(a) of the CSA (21 U.S.C. 811(a)), and delegated to the 
Administrator of DEA by Department of Justice regulations (28 CFR 
0.100) the Administrator hereby amends 21 CFR part 1308 as follows:

PART 1308--SCHEDULES OF CONTROLLED SUBSTANCES

    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
1. Section 1308.14 is amended by redesignating paragraphs (e) and (f) 
as paragraphs (f) and (g), and adding a new paragraph (e) to read as 
follows:


Sec.  1308.14  Schedule IV.

* * * * *
    (e) Lorcaserin. Any material, compound, mixture, or preparation 
which contains any quantity of the following substances, including its 
salts, isomers, and salts of such isomers, whenever the existence of 
such salts, isomers, and salts of isomers is possible:

(1) Lorcaserin.................................................     1625
 

* * * * *

    Dated: April 29, 2013.
Michele M. Leonhart,
Administrator.
[FR Doc. 2013-10895 Filed 5-7-13; 8:45 am]
BILLING CODE 4410-09-P