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.

Rules and Regulations Federal Register

26701 

Vol. 78, No. 89 

Wednesday, May 8, 2013 

1As 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.’’ 

FARM CREDIT ADMINISTRATION 

12 CFR Part 615 

RIN 3052–AC54 

Funding and Fiscal Affairs, Loan 

Policies and Operations, and Funding 

Operations; Liquidity and Funding; 

Correction 

AGENCY: Farm Credit Administration. 

ACTION: Final rule; correction. 

SUMMARY: 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. 

SUPPLEMENTARY INFORMATION: 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. 

■ 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. 

[FR Doc. 2013–10820 Filed 5–7–13; 8:45 am] 

BILLING CODE 6705–01–P 

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. 

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. 

Background 

Lorcaserin ((R)–8–chloro–1–methyl– 

2,3,4,5–tetrahydro–1H–3–benzepine 

hydrochloride hemihydrate) is a new 

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26702 Federal Register / Vol. 78, No. 89 / Wednesday, May 8, 2013 / Rules and Regulations 

2Shram et al. (2011) Clin Pharmacol Ther; 

89(5):683–92. 

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). 

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 

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 

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 

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Federal Register / Vol. 78, No. 89 / Wednesday, May 8, 2013 / Rules and Regulations 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 weightloss 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 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 

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 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 

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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)). 

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., 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 

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Federal Register / Vol. 78, No. 89 / Wednesday, May 8, 2013 / Rules and Regulations 26705 

3UMRA 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). 

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). 

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: 

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

unless otherwise noted. 

■ 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, 

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 

AGENCY: Federal Communications 

Commission. 

ACTION: Final rule. 

SUMMARY: 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: 

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