Federal Register / Vol. 77, No. 244 / Wednesday, December 19, 2012 / Proposed Rules 75075 

detail the scope of the Agency’s 

authority. 

We are issuing this rulemaking under 

the authority described in ‘‘Subtitle VII, 

Part A, Subpart III, Section 44701: 

General requirements.’’ Under that 

section, Congress charges the FAA with 

promoting safe flight of civil aircraft in 

air commerce by prescribing regulations 

for practices, methods, and procedures 

the Administrator finds necessary for 

safety in air commerce. This regulation 

is within the scope of that authority 

because it addresses an unsafe condition 

that is likely to exist or develop on 

products identified in this rulemaking 

action. 

Regulatory Findings 

We determined that this proposed AD 

would not have federalism implications 

under Executive Order 13132. This 

proposed AD would not have a 

substantial direct effect on the States, on 

the relationship between the national 

Government and the States, or on the 

distribution of power and 

responsibilities among the various 

levels of government. 

For the reasons discussed, I certify 

this proposed regulation: 

1. Is not a ‘‘significant regulatory 

action’’ under Executive Order 12866; 

2. Is not a ‘‘significant rule’’ under the 

DOT Regulatory Policies and Procedures 

(44 FR 11034, February 26, 1979); 

3. Will not affect intrastate aviation in 

Alaska to the extent that it justifies 

making a regulatory distinction; and 

4. Will not have a significant 

economic impact, positive or negative, 

on a substantial number of small entities 

under the criteria of the Regulatory 

Flexibility Act. 

We prepared an economic evaluation 

of the estimated costs to comply with 

this proposed AD and placed it in the 

AD docket. 

List of Subjects in 14 CFR Part 39 

Air transportation, Aircraft, Aviation 

safety, Incorporation by reference, 

Safety. 

The Proposed Amendment 

Accordingly, under the authority 

delegated to me by the Administrator, 

the FAA proposes to amend 14 CFR part 

39 as follows: 

PART 39—AIRWORTHINESS 

DIRECTIVES 

1. The authority citation for part 39 

continues to read as follows: 

Authority: 49 U.S.C. 106(g), 40113, 44701. 

§ 39.13 [Amended] 

2. The FAA amends § 39.13 by adding 

the following new airworthiness 

directive (AD): 

Eurocopter Deutschland GmbH: Docket No. 

FAA–2011–1285; Directorate Identifier 

2010–SW–073–AD. 

(a) Applicability 

This AD applies to Model BO–105A, BO– 

105C, BO–105LS A–1, BO–105LS A–3, and 

BO–105S helicopters, with a main rotor 

blade, part number 105–15103, 105–15141, 

105–15141V001, 105–15143, 105–15150, 

105–15150V001, 105–15152, 105–81013, 

105–87214, 1120–15101, or 1120–15103; 

where the main rotor blade erosion protective 

shell (abrasion strip) was replaced between 

September 1, 2006 and March 31, 2010, 

inclusive; certificated in any category. 

(b) Unsafe Condition 

This AD defines the unsafe condition as 

debonding of a main rotor blade erosion 

protective shell (abrasion strip). This 

condition could result in loss of the abrasion 

strip and an unbalanced main rotor, high 

vibration, damage to the tail boom or tail 

rotor, and loss of control of the helicopter. 

(c) Compliance 

You are responsible for performing each 

action required by this AD within the 

specified compliance time unless it has 

already been accomplished prior to that time. 

(d) Required Actions 

(1) Within 50 hours time-in-service, 

inspect the main rotor blade for debonding of 

the erosion protective shell by tap testing the 

abrasion strip of the leading edge of each 

main rotor blade. 

(2) If the abrasion strip is debonding in any 

area, before further flight, replace the main 

rotor blade. 

(e) Alternative Methods of Compliance 

(AMOCs) 

(1) The Manager, Safety Management 

Group, FAA, may approve AMOCs for this 

AD. Send your proposal to: Jim Grigg, 

Manager, Safety Management Group, 

Rotorcraft Directorate, FAA, 2601 Meacham 

Blvd., Fort Worth, Texas 76137; telephone 

(817) 222–5110; email jim.grigg@faa.gov. 

(2) For operations conducted under a 14 

CFR part 119 operating certificate or under 

14 CFR part 91, subpart K, we suggest that 

you notify your principal inspector, or 

lacking a principal inspector, the manager of 

the local flight standards district office or 

certificate holding district office before 

operating any aircraft complying with this 

AD through an AMOC. 

(f) Additional Information 

(1) Eurocopter Emergency Alert Service 

Bulletin No. ASB BO105–10–124, Revision 1, 

dated October 18, 2010, and No. ASB– 

BO105LS–10–12, Revision 1, dated October 

20, 2010, which are not incorporated by 

reference, contain additional information 

about the subject of this AD. For this service 

information, contact American Eurocopter 

Corporation, 2701 N. Forum Drive, Grand 

Prairie, Texas 75052; telephone (972) 641– 

0000 or (800) 232–0323; fax (972) 641–3775; 

or at http://www.eurocopter.com/techpub. 

You may review a copy of the service 

information at the FAA, Office of the 

Regional Counsel, Southwest Region, 2601 

Meacham Blvd., Room 663, Fort Worth, 

Texas 76137. 

(2) The subject of this AD is addressed in 

European Aviation Safety Agency Emergency 

AD No. 2010–0216–E, dated October 21, 2010 

(corrected October 29, 2010). 

(g) Subject 

Joint Aircraft Service Component (JASC) 

Code: 6210, Main Rotor Blades. 

Issued in Fort Worth, Texas, on December 

12, 2012. 

S. Frances Cox, 

Acting Directorate Manager, Rotorcraft 

Directorate, Aircraft Certification Service. 

[FR Doc. 2012–30588 Filed 12–18–12; 8:45 am] 

BILLING CODE 4910–13–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: Notice of proposed rulemaking. 

SUMMARY: The Drug Enforcement 

Administration (DEA) proposes placing 

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 proposed 

action is based on a recommendation 

from the Assistant Secretary for Health 

of the Department of Health and Human 

Services (HHS) and on an evaluation of 

all other relevant data by DEA. If 

finalized, this action would impose the 

regulatory controls and criminal 

sanctions of Schedule IV on the 

manufacture, distribution, dispensing, 

importation, exportation, and 

possession of lorcaserin and products 

containing lorcaserin. 

DATES: DEA will permit interested 

persons to file written comments on this 

proposal pursuant to 21 CFR 1308.43(g). 

Electronic comments must be submitted 

and written comments must be 

postmarked on or before January 18, 

2013. Commenters should be aware that 

the electronic Federal Docket 

Management System will not accept 

comments after midnight Eastern Time 

on the last day of the comment period. 


wreier-aviles on DSK5TPTVN1PROD with 
75076 Federal Register / Vol. 77, No. 244 / Wednesday, December 19, 2012 / Proposed Rules 

1 21 CFR 1300.01. 2 21 CFR 1300.01. 

Interested persons, defined as those 

‘‘adversely affected or aggrieved by any 

rule or proposed rule issuable pursuant 

to section 201 of the Act (21 U.S.C. 

811),’’ 1 may file a request for hearing or 

waiver of participation pursuant to 21 

CFR 1308.44 and in accordance with 21 

CFR 1316.45. Requests for hearing and 

waivers of participation must be 

received on or before January 18, 2013. 

ADDRESSES: To ensure proper handling 

of comments, please reference ‘‘Docket 

No. DEA–369’’ on all electronic and 

written correspondence. DEA 

encourages all comments be submitted 

electronically through http:// 

www.regulations.gov using the 

electronic comment form provided on 

that site. An electronic copy of this 

document and supplemental 

information to this proposed rule are 

also available at the http:// 

www.regulations.gov Web site for easy 

reference. Paper comments that 

duplicate the electronic submission are 

not necessary as all comments 

submitted to www.regulations.gov will 

be posted for public review and are part 

of the official docket record. Should 

you, however, wish to submit written 

comments via regular or express mail, 

they should be sent to the Drug 

Enforcement Administration, Attention: 

DEA Federal Register Representative/ 

OD, 8701 Morrissette Drive, Springfield, 

VA 22152. All requests for hearing and 

waivers of participation must be sent to 

Drug Enforcement Administration, 

Attention: Hearing Clerk/LJ, 8701 

Morrissette Drive, Springfield, VA 

22152. 

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: 

Posting of Public Comments 

Please note that all comments 

received are considered part of the 

public record and made available for 

public inspection online at http:// 

www.regulations.gov and in the DEA’s 

public docket. Such information 

includes personal identifying 

information (such as your name, 

address, etc.) voluntarily submitted by 

the commenter. 

If you want to submit personal 

identifying information (such as your 

name, address, etc.) as part of your 

comment, but do not want it to be 

posted online or made available in the 

public docket, you must include the 

phrase ‘‘PERSONAL IDENTIFYING 

INFORMATION’’ in the first paragraph 

of your comment. You must also place 

all the personal identifying information 

you do not want posted online or made 

available in the public docket in the first 

paragraph of your comment and identify 

what information you want redacted. 

If you want to submit confidential 

business information as part of your 

comment, but do not want it to be 

posted online or made available in the 

public docket, you must include the 

phrase ‘‘CONFIDENTIAL BUSINESS 

INFORMATION’’ in the first paragraph 

of your comment. You must also 

prominently identify confidential 

business information to be redacted 

within the comment. If a comment has 

so much confidential business 

information that it cannot be effectively 

redacted, all or part of that comment 

may not be posted online or made 

available in the public docket. 

Personal identifying information and 

confidential business information 

identified and located as set forth above 

will be redacted and the comment, in 

redacted form, will be posted online and 

placed in the DEA’s public docket file. 

Please note that the Freedom of 

Information Act applies to all comments 

received. If you wish to inspect the 

agency’s public docket file in person by 

appointment, please see the ‘‘For 

Further Information Contact’’ paragraph, 

above. 

Requests for Hearing or Waiver of 

Participation in Hearing 

In accordance with the provisions of 

the CSA (21 U.S.C. 811(a)), this action 

is a formal rulemaking ‘‘on the record 

after opportunity for a hearing.’’ Such 

proceedings are conducted pursuant to 

the provisions of the Administrative 

Procedure Act (5 U.S.C. 556 and 557) 

and 21 CFR 1308.41. Pursuant to 21 CFR 

1308.44(a) and (c), requests for a hearing 

and waivers of participation may be 

submitted only by interested persons, 

defined as those ‘‘adversely affected or 

aggrieved by any rule or proposed rule 

issuable pursuant to section 201 of the 

Act (21 U.S.C. 811).’’ 2 Requests for a 

hearing must conform to the 

requirements of 21 CFR 1308.44(a) and 

1316.47. A request should state, with 

particularity, the interest of the person 

in the proceeding and the objections or 

issues, if any, concerning which the 

person desires to be heard. Any waiver 

must conform to the requirements of 21 

CFR 1308.44(c), including a written 

statement regarding the interested 

person’s position on the matters of fact 

and law involved in any hearing. 

Please note that pursuant to 21 U.S.C. 

811(a), the purpose and subject matter 

of the hearing is restricted to ‘‘(A) 

find[ing] that such drug or other 

substance has a potential for abuse, and 

(B) mak[ing] 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 * * *’’ 

Requests for hearing and waivers of 

participation in the hearing should be 

submitted to DEA using the address 

information provided above. DEA may 

grant a hearing only ‘‘for the purpose of 

receiving factual evidence and expert 

opinion regarding the issues involved in 

the issuance, amendment or repeal of a 

rule issuable’’ pursuant to 21 U.S.C. 

811(a). 

Legal Authority 

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 (CSA) and the 

Controlled Substances Import Export 

Act (CSIEA) (21 U.S.C. 801–971), as 

amended (hereinafter, ‘‘CSA’’). 

Under the CSA, controlled substances 

are classified in one of five schedules 

based upon their potential for abuse, 

their currently accepted medical use, 

safety and the degree of dependence the 

substance may cause. 21 U.S.C. 812. The 

initial schedules of controlled 

substances are found at 21 U.S.C. 812(c). 

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. 

Background 

Lorcaserin ((R)-8-chloro-1-methyl2,3,4,5-tetrahydro-1H-3-benzepine 

hydrochloride hemihydrate) is a new 

chemical entity which has central 

nervous system hallucinogenic 

properties. Lorcaserin is a serotonin 

receptor agonist, at the 5HT2C and 

5HT2A receptor subtypes. Lorcaserin 

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 


wreier-aviles on DSK5TPTVN1PROD with 
Federal Register / Vol. 77, No. 244 / Wednesday, December 19, 2012 / Proposed Rules 75077 

3Comprehensive Drug Abuse Prevention and 

Control Act of 1970, H.R. Rep. No. 91–1444, 91st 

Cong., Sess. 1 (1970); 1970 U.S.C.C.A.N. 4566, 4601. 

management and it will be marketed 

under the trade name BELVIQ®. 

Proposed Determination To Schedule 

Lorcaserin 

Pursuant to the CSA, 21 U.S.C. 811(a), 

proceedings to add a drug or substance 

to those controlled under the CSA may 

be initiated by request of the Secretary 

of HHS. On June 25, 2012, HHS 

provided DEA with a scientific and 

medical evaluation document prepared 

by FDA entitled ‘‘Basis for the 

Recommendation for Control of 

Lorcaserin in Schedule IV of the 

Controlled Substances Act.’’ Pursuant to 

21 U.S.C. 811(b), (c), and (f), this 

document contained an eight-factor 

analysis of the abuse potential of 

lorcaserin as a new drug, along with 

HHS’ recommendation to control 

lorcaserin under Schedule IV of the 

CSA. 

In response, DEA conducted an eightfactor analysis of abuse potential of 

lorcaserin pursuant to 21 U.S.C. 811(c). 

Included below is a brief summary of 

each factor as considered by HHS and 

DEA. Please note that both the DEA and 

HHS analyses are available in whole in 

the ‘‘Supporting and Related Material’’ 

of the public docket for this rule at 

www.regulations.gov under docket 

number DEA–369. Full analysis of and 

citations to the information referenced 

in the summary may be found in the 

supporting material. 

1. The Drug’s Actual or Relative 

Potential for Abuse: Lorcaserin is a new 

chemical substance that has not been 

marketed in the U.S. or in any other 

country. As such, there is no 

information available which details 

actual abuse of lorcaserin. However, the 

legislative history of the CSA offers 

another methodology for assessing a 

drug or substance’s potential for abuse: 

The drug or drugs containing such a 

substance are new drugs so related in their 

action to a drug or drugs already listed as 

having a potential for abuse to make it likely 

that the drug will have the same potentiality 

for abuse as such drugs, thus making it 

reasonable to assume that there may be 

significant diversions from legitimate 

channels, significant use contrary to or 

without medical advice, or that it has a 

substantial capability of creating hazards to 

the health of the user or to the safety of the 

community.3

According to HHS, lorcaserin is an 

agonist at the serotonin receptor 

subtypes 5–HT2C and 5–HT2A. 

Lorcaserin is indicated as an addition to 

a reduced-calorie diet and exercise, for 

chronic weight management. There is 

evidence, described below, that 

lorcaserin produces subjective effects in 

humans and in animals that are similar 

to those produced by zolpidem 

(Schedule IV) and ketamine (Schedule 

III) 

HHS described a human abuse 

potential study in recreational drug 

abusers of psychedelic drugs and CNS 

depressants, in which lorcaserin and the 

comparator drugs zolpidem (Schedule 

IV) and ketamine (Schedule III) 

produced significant increases on 

positive subjective measures (visual 

analog scales (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 Addiction Research Center 

Inventory (ARCI), compared to placebo. 

HHS summarized that these subjective 

response data suggest that lorcaserin 

produces subjective effects similar to 

those produced by zolpidem and 

ketamine. According to HHS, 20–60 mg 

of lorcaserin produced a high rate of 

euphoria in 6–19% of the subjects in a 

human abuse potential study. The 

incidence of euphoria following 

lorcaserin administration in the human 

abuse potential study is similar to that 

reported following zolpidem (Schedule 

IV) administration (13–16%) and lower 

than that following ketamine (Schedule 

III) administration (50%). 

According to HHS, lorcaserin is not 

available or marketed in any country. 

Thus there is no evidence of lorcaserin 

diversion, illicit manufacturing, or 

deliberate ingestion. Because lorcaserin 

has been shown to produce euphoria in 

humans, it is anticipated that there will 

be significant use contrary to or without 

medical advice. Lorcaserin is not readily 

synthesized from available substances, 

and thus its diversion will be likely 

from the legitimate channels. 

2. Scientific Evidence of the Drug’s 

Pharmacological Effects, If Known: HHS 

stated that lorcaserin is a 5–HT2C and 5– 

HT2A serotonin receptor agonist. DEA 

further notes that it has been shown that 

lorcaserin through activation of 5–HT2C

receptors causes inositol phosphate 

accumulation with an EC50 of 9 nM. 

Lorcaserin also activated the 5–HT2A

and 5–HT2B receptors, with EC50s of 168 

nM and 943 nM, respectively. 

HHS stated that acutely, lorcaserin 

decreases locomotor activity in rats. 

Tolerance does develop to this effect, 

because after 21 days, lorcaserin does 

not affect the locomotor activity of the 

rats. DEA further notes that a study 

showed that food intake in rats was 

reduced after a single administration of 

lorcaserin. The doses administered were 

3, 6, 12, and 24 mg/kg. Lorcaserin 

decreased the cumulative food intake at 

2, 4, 6, and 22 hours. The ED50 for food 

intake inhibition was 18 mg/kg. 

According to HHS’ review, a drug 

discrimination study conducted in 2,5- 

dimethoxy-4-methylamphetamine 

(DOM)-trained rats showed that 

lorcaserin (0.1–10 mg/kg) produced full 

generalization (≥ 80%) to the DOM cue 

in 7 of 9 rats. DOM is a Schedule I 

hallucinogen and a 5-HT2A and 5-HT2C

receptor agonist. These data suggest that 

lorcaserin in doses 0.1 to 10 mg/kg 

produces discriminative stimulus 

responses similar to DOM, a 

hallucinogen. 

As described by HHS in a human 

abuse potential study with individuals 

with a history of abusing drugs, 

lorcaserin was evaluated for its abuse 

potential; it was compared to ketamine 

(Schedule III NMDA antagonist), 

zolpidem (Schedule IV GABA agonist), 

and a placebo. In clinical trials, 

lorcaserin, similar to ketamine and 

zolpidem, produced euphoric and 

hallucinogenic adverse events (AEs). 

3. The State of the Current Scientific 

Knowledge Regarding the Drug or Other 

Substance: HHS states that lorcaserin 

((R)-8-chloro-1-methyl-2,3,4,5- 

tetrahydro-1H-3-benzepine 

hydrochloride hemihydrate) is watersoluble. The molecular formula is 

C11H14ClN and its molecular weight is 

241.6 g/mol, the CAS number is 

616202–92–7. 

According to HHS, in humans, 

lorcaserin is rapidly absorbed from the 

gastrointestinal tract after oral 

administration, the tmax (time to reach 

maximum plasma concentration) is ≤ 2 

hours and its half-life in plasma is about 

11 hours. DEA further notes that after a 

single oral administration of 10 mg/kg 

lorcaserin to rats, the absorption from 

the gastrointestinal tract was rapid, 

resulting in a mean maximum plasma 

concentration (Cmax) of 0.76 mg/ml at 

0.25 hour. The time from oral 

administration to brain maximal 

exposure was 1 hour. 

According to HHS, the major 

circulating metabolite of lorcaserin is 

lorcaserin sulfamate (M1). Lorcaserin is 

metabolized by the liver and excreted by 

the kidney. M1 is considered inactive 

and it does not bind significantly to 

monoamine transporters. DEA further 

notes that the major metabolite in the 

urine is N-carbamoyl glucuronide (M5). 

4. Its History and Current Pattern of 

Abuse: History and current pattern of 

abuse of lorcaserin is not available since 

it has not been marketed in any country. 

As stated in HHS’ review, lorcaserin 

produced positive subjective effects in a 

human abuse potential study that are 


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75078 Federal Register / Vol. 77, No. 244 / Wednesday, December 19, 2012 / Proposed Rules 

similar to those produced by zolpidem 

(Schedule IV) and ketamine (Schedule 

III). HHS states that the positive 

subjective effects reported from 

supratherapeutic doses of lorcaserin 

administration, are predictive of its 

potential for abuse. 

5. The Scope, Duration, and 

Significance of Abuse: According to the 

HHS review, the information on 

lorcaserin’s scope, duration and 

significance of abuse is not available 

since it has not been marketed in any 

country. Thus, the evaluation of the 

significance of abuse of lorcaserin 

derives from positive indicators in premarket clinical trials which are believed 

to be predictive of drug abuse. Based on 

the AEs reported in the clinical efficacy 

studies and the data from a human 

abuse potential lorcaserin study, HHS 

concluded that the scope and 

significance of the abuse potential of 

lorcaserin is similar to Schedule IV 

substances. HHS states that marketing 

lorcaserin as a Schedule IV substance 

will decrease its abuse, as opposed to 

marketing it as an uncontrolled or 

Schedule V substance. 

6. What, if any, Risk There is to the 

Public Health: According to HHS, the 

abuse potential of lorcaserin presents a 

risk to the public health. HHS states that 

lorcaserin produces a number of AEs 

that are commonly seen with other 

Schedule IV substances that are abused. 

Some of these AEs include feeling 

jittery, psychomotor hyperactivity, 

paresthesia, abnormal dreams, and state 

of confusion. Headache, nausea, and 

dizziness were the most commonly 

reported AEs in lorcaserin clinical 

studies. In a human abuse potential 

study, 20–60 mg lorcaserin produced a 

high incidence of the AE euphoria in 6– 

19% of the subjects. According to HHS, 

because lorcaserin binds to 5-HT2

receptors and generalizes to 5-HT2

agonists in drug discrimination studies 

in rats, it is expected to have a 

hallucinogenic profile. DEA further 

notes that in the human abuse potential 

study conducted by Shram and 

colleagues (2011), supratherapeutic 

doses of lorcaserin were associated with 

significantly higher peak scores on the 

‘‘Detached’’ (40 and 60 mg), 

‘‘Hallucinations’’ (40 mg), and ‘‘Spaced 

Out’’ (40 and 60 mg) visual analog 

scales. 

7. Its Psychic or Physiological 

Dependence Liability: According to 

HHS’ review, there were two clinical 

studies conducted to determine the 

ability of lorcaserin to induce physical 

dependence. The patients in these 

studies were obese and lorcaserin was 

administered for 4 and 12 weeks prior 

to drug discontinuation. Upon 

lorcaserin discontinuation, there were 

no signs of changes in mood, food 

interest, or body weight. 

Discontinuation of lorcaserin 

administration to animals also did not 

produce typical withdrawal symptoms. 

However, according to HHS, the ability 

of lorcaserin to produce hallucinations, 

euphoria, and positive subjective 

responses at supratherapeutic doses is 

suggestive of its potential to produce 

psychic dependence. 

8. Whether the Substance is an 

Immediate Precursor of a Substance 

Already Controlled Under the CSA: 

Lorcaserin is not an immediate 

precursor of a substance already 

controlled under the CSA. 

Conclusion: Based on consideration of 

the scientific and medical evaluation 

conducted by HHS and its 

recommendation, and after considering 

its own eight-factor analysis, DEA has 

determined that these facts and all 

relevant data constitute substantial 

evidence of potential for abuse of 

lorcaserin. As such, DEA hereby 

proposes to schedule lorcaserin as a 

controlled substance under the CSA. 

Proposed 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 in placing 

a drug or other substance in any 

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), 

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 the Schedule IV 

substances; 

(2) Lorcaserin has a currently 

accepted medical use in treatment in the 

United States. Lorcaserin 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 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 

control in Schedule IV of the CSA (21 

U.S.C. 812(b)(4)). 

Requirements for Handling Lorcaserin 

If this rule is finalized as proposed, 

lorcaserin would be subject to CSA 

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 instructional 

activities or conduct research with 

lorcaserin, would need to be registered 

to conduct such activities pursuant to 

21 U.S.C. 822 and in accordance with 21 

CFR Part 1301. 

Security. Lorcaserin would be subject 

to Schedules III–V security 

requirements and would need to 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. 

Labeling and Packaging. All labels 

and labeling for commercial containers 

of lorcaserin which are distributed on or 

after finalization of this rule would need 

to be in accordance with 21 CFR 

1302.03–1302.07, pursuant to 21 U.S.C. 

825. 

Inventory. Every registrant required to 

keep records and who possesses any 

quantity of lorcaserin would be required 

to 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, and 1304.11. 

Every registrant who desires registration 

in Schedule IV for lorcaserin would be 

required to conduct an inventory of all 

stocks of the substance on hand at the 

time of registration. 

Records. All registrants would be 

required to 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. 

Prescriptions. All prescriptions for 

lorcaserin or prescriptions for products 

containing lorcaserin would be required 

to be issued as a controlled substance 

pursuant to 21 U.S.C. 829 and in 

accordance with 21 CFR 1306, including 

but not limited to 21 CFR 1306.03– 

1306.06, 1306.08, 1306.09, and 1306.21– 

1306.27. 

Importation and Exportation. All 

importation and exportation of 

lorcaserin would need to be done in 


wreier-aviles on DSK5TPTVN1PROD with 
Federal Register / Vol. 77, No. 244 / Wednesday, December 19, 2012 / Proposed Rules 75079 

accordance with 21 CFR Part 1312, 

pursuant to 21 U.S.C. 952, 953, 957, and 

958. 

Criminal Liability. Any activity with 

lorcaserin not authorized by, or in 

violation of, Subchapter I Part D and 

Subchapter II of the CSA occurring on 

or after finalization of this proposed rule 

would be unlawful. 

Regulatory Analyses 

Executive Orders 12866 and 13563 

In accordance with 21 U.S.C. 811(a), 

this proposed 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. 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 proposed regulation meets the 

applicable standards set forth in 

Sections 3(a) and 3(b)(2) of Executive 

Order 12988 Civil Justice Reform to 

eliminate ambiguity, minimize 

litigation, establish clear legal standards 

and reduce burden. 

Executive Order 13132 

This proposed rulemaking does not 

preempt or modify any provision of 

State law; nor does it impose 

enforcement responsibilities on any 

State; nor does it diminish the power of 

any State to enforce its own laws. 

Accordingly, this rulemaking does not 

have federalism implications warranting 

the application of Executive Order 

13132. 

Executive Order 13175 

This proposed rule will not have 

tribal implications and will not impose 

substantial direct compliance costs on 

Indian tribal governments. 

Regulatory Flexibility Act 

The Administrator, in accordance 

with the Regulatory Flexibility Act (5 

U.S.C. 601–612), has reviewed this 

proposed rule and by approving it 

certifies that it will not have a 

significant economic impact on a 

substantial number of small entities. 

Lorcaserin products, as recently 

approved by the FDA, will be used as 

an adjunct treatment of partial onset 

seizure. Handlers of lorcaserin will also 

handle other controlled substances used 

as anti-seizure agents, which are already 

subject to the regulatory requirements of 

the CSA. 

Unfunded Mandates Reform Act of 

1995 

This rule will not result in the 

expenditure by State, local and tribal 

governments, in the aggregate, or by the 

private sector, of $136,000,000 or more 

(adjusted for inflation) in any one year, 

and will not significantly or uniquely 

affect small governments. Therefore, no 

actions were deemed necessary under 

provisions of the Unfunded Mandates 

Reform Act of 1995. 

Paperwork Reduction Act of 1995 

This action does not impose a new 

collection of information requirement 

under the Paperwork Reduction Act of 

1995, 44 U.S.C. 3501–3521. 

List of Subjects in 21 CFR Part 1308 

Administrative practice and 

procedure, Drug traffic control, 

Reporting and recordkeeping 

requirements. 

For the reasons set out above, 21 CFR 

part 1308 is proposed to be amended as 

follows: 

PART 1308—SCHEDULES OF 

CONTROLLED SUBSTANCES 

1. The authority citation for part 1308 

continues to read as follows: 

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

unless otherwise noted. 

2. 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: December 13, 2012. 

Michele M. Leonhart, 

Administrator. 

[FR Doc. 2012–30531 Filed 12–18–12; 8:45 am] 

BILLING CODE 4410–09–P 

DEPARTMENT OF HOMELAND 

SECURITY 

Coast Guard 

33 CFR Part 165 

[Docket Number USCG–2012–1013] 

RIN 1625–AA00 

Safety Zone; Woldenburg Park, 

Mississippi River, New Orleans, LA 

AGENCY: Coast Guard, DHS. 

ACTION: Notice of Proposed Rulemaking. 

SUMMARY: The Captain of the Port New 

Orleans, under the authority of the Ports 

and Waterways Safety Act, intends to 

establish a temporary safety zone on the 

Mississippi River in the vicinity of 

Woldenburg Park, mile marker 94 to 

mile marker 96, extending out 300 feet 

from the East Bank of the Mississippi 

River during Super Bowl 2013 

celebratory events. The Super Bowl is a 

large scale event that poses many public 

safety concerns due to the number of 

people that will attend. This safety zone 

would be established to protect the 

public from the hazards created by 

congested river traffic. This rule would 

be effective from 6:00 a.m. on January 

29, 2013 through 6:00 a.m. on February 

4, 2013. The zone will be enforced 

between the hours of 8:00 a.m. and 

10:00 p.m. on each day of the effective 

period described above. 

DATES: Comments and related material 

must be received by the Coast Guard on 

or before December 30, 2012. 

ADDRESSES: You may submit comments 

identified by docket number using any 

one of the following methods: 

(1) Federal eRulemaking Portal: 

http://www.regulations.gov. 

(2) Fax: 202–493–2251. 

(3) Mail or Delivery: Docket 

Management Facility (M–30), U.S. 

Department of Transportation, West 

Building Ground Floor, Room W12–140, 

1200 New Jersey Avenue SE., 

Washington, DC 20590–0001. Deliveries 

accepted between 9 a.m. and 5 p.m., 

Monday through Friday, except Federal 

holidays. The telephone number is 202– 

366–9329. 

See the ‘‘Public Participation and 

Request for Comments’’ portion of the 

SUPPLEMENTARY INFORMATION section 

below for further instructions on 

submitting comments. To avoid 

duplication, please use only one of 

these three methods. 

FOR FURTHER INFORMATION CONTACT: If 

you have questions on this rule, call or 

email LCDR Kenneth Blair, Sector New 

Orleans, U.S. Coast Guard; telephone 

(504) 365–2392, email 


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