62500 Federal Register / Vol. 78, No. 204 / Tuesday, October 22, 2013 / Proposed Rules 

Airmen. The effective date and time will 

thereafter be continuously published in the 

Airport/Facility Directory. 

Paragraph 6002 Class E airspace 

Designated as Surface Areas. 

* * * * * 

AWP CA E2 Salinas, CA [Removed] 

Paragraph 6004 Class E airspace areas 

designated as an extension to Class D surface 

area. 

* * * * * 

AWP CA E4 Salinas, CA [Modified] 

Salinas Municipal Airport, CA 

(Lat. 36°39′46′′ N., long. 121°36′23′′ W.) 

That airspace extending upward from the 

surface within 1.8 miles each side of the 150° 

bearing of Salinas Municipal Airport 

extending from the 4.3-mile radius of the 

airport to 8 miles southeast of the airport. 

This Class E airspace area is effective during 

the specific dates and times established in 

advance by a Notice to Airmen. The effective 

date and time will thereafter be continuously 

published in the Airport/Facility Directory. 

Paragraph 6005 Class E airspace areas 

extending upward from 700 feet or more 

above the surface of the earth. 

* * * * * 

AWP CA E5 Salinas, CA [New] 

Salinas Municipal Airport, CA 

(Lat. 36°39′46′′ N., long. 121°36′23′′ W.) 

That airspace extending upward from 700 

feet above the surface within a 13.1-mile 

radius of Salinas Municipal Airport. 

Issued in Seattle, Washington, on 

September 26, 2013. 

Johanna Forkner, 

Acting Manager, Operations Support Group, 

Western Service Center. 

[FR Doc. 2013–24744 Filed 10–21–13; 8:45 am] 

BILLING CODE 4910–13–P 

DEPARTMENT OF JUSTICE 

Drug Enforcement Administration 

21 CFR Part 1308 

[Docket No. DEA–374] 

Schedules of Controlled Substances: 

Placement of Perampanel into 

Schedule III 

AGENCY: Drug Enforcement 

Administration, Department of Justice. 

ACTION: Notice of proposed rulemaking. 

SUMMARY: The Drug Enforcement 

Administration (DEA) proposes to place 

the substance perampanel [2-(2-oxo-1- 

phenyl-5-pyridin-2-yl-1,2- 

dihydropyridin-3-yl) benzonitrile 

hydrate], including its salts, isomers, 

and salts of isomers, into Schedule III 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 the DEA. If finalized, 

this action would impose the regulatory 

controls and administrative, civil, and 

criminal sanctions of Schedule III 

controlled substances on persons who 

handle (manufacture, distribute, 

dispense, import, export, engage in 

research, conduct instructional 

activities, and possess) or propose to 

handle perampanel. 

DATES: Interested persons may file 

written comments on this proposal in 

accordance with 21 CFR 1308.43(g). 

Comments must be submitted 

electronically or postmarked on or 

before November 21, 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. 

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),’’ 21 CFR 1300.01, may file a 

request for hearing or waiver of 

participation pursuant to 21 CFR 

1308.44 and in accordance with 21 CFR 

1316.45 and 1316.47. Requests for 

hearing, notices of appearance, and 

waivers of an opportunity for a hearing 

or to participate in a hearing must be 

received on or before November 21, 

2013. 

ADDRESSES: To ensure proper handling 

of comments, please reference ‘‘Docket 

No. DEA–374’’ on all electronic and 

written correspondence. The DEA 

encourages that all comments be 

submitted through the Federal 

eRulemaking Portal, which provides the 

ability to type short comments directly 

into the comment field on the Web page 

or attach a file for lengthier comments. 

Go to 

http://www.regulations.gov and follow 

the on-line instructions at that site for 

submitting comments. An electronic 

copy of this document and 

supplemental information to this 

proposed rule are also available at 

http://www.regulations.gov for easy 

reference. Paper comments that 

duplicate electronic submissions are not 

necessary. All comments submitted to 

http://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, in lieu of electronic 

comments, they should be sent via 

regular or express mail to: Drug 

Enforcement Administration, Attention: 

DEA Federal Register Representative/ 

ODW, 8701 Morrissette Drive, 

Springfield, Virginia 22152. All requests 

for hearing and waivers of participation 

must be sent to: Drug Enforcement 

Administration, Attention: Hearing 

Clerk/LJ, 8701 Morrissette Drive, 

Springfield, Virginia 22152. 

FOR FURTHER INFORMATION CONTACT: 

Ruth A. Carter, Chief, Policy Evaluation 

and Analysis Section, Office of 

Diversion Control, Drug Enforcement 

Administration; Mailing Address: 8701 

Morrissette Drive, Springfield, Virginia 

22152; Telephone: (202) 598–6812. 

SUPPLEMENTARY INFORMATION: 

Posting of Public Comments 

Please note that comments received in 

response to this docket are considered 

part of the public record and will be 

made available for public inspection 

and posted at http:// 

www.regulations.gov. 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 made 

public, 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 made publicly 

available 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 made 

publicly available, 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 made publicly available. 

Comments containing personally 

identifying information or confidential 

business information identified as 

directed above will be made publicly 

available in redacted form. The Freedom 

of Information Act (FOIA) applies to all 

comments received. If you wish to 

personally inspect the comments and 

materials received or the supporting 

documentation the DEA used in 

preparing the proposed action, these 

materials will be available for public 

inspection by appointment. To arrange 


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a viewing, please see the FOR FURTHER

INFORMATION CONTACT paragraph, above. 

Requests for Hearing, Notice of 

Appearance at Hearing, or Waiver of 

Participation in Hearing 

Pursuant to 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 (APA) (5 U.S.C. 551– 

559), 21 CFR 1308.41–1308.45, and 21 

CFR part 1316 subpart D. In accordance 

with 21 CFR 1308.44(a)–(c), requests for 

a hearing, notices of appearance, and 

waivers of an opportunity for a hearing 

or to participate in a hearing 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).’’ 21 CFR 1300.01. 

Such requests or notices must conform 

to the requirements of 21 CFR 

1308.44(a) or (b) and 1316.47 or 

1316.48, as applicable, and include a 

statement of 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) and 1316.49, 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 a hearing held in relation to this 

rulemaking 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 [Title 

21] for the schedule in which such drug 

is to be placed. . . .’’ Requests for 

hearing, notices of appearance at the 

hearing, and waivers of an opportunity 

for a hearing or to participate in a 

hearing must be submitted to the DEA 

using the address information provided 

above. 

Legal Authority 

The DEA implements and enforces 

titles II and III of the Comprehensive 

Drug Abuse Prevention and Control Act 

of 1970 and the Controlled Substances 

Import and Export Act, as amended, and 

collectively referred to as the Controlled 

Substances Act (CSA) (21 U.S.C. 801– 

971). The DEA publishes the 

implementing regulations for these 

statutes in title 21 of the Code of Federal 

Regulations (CFR), parts 1300 to 1321. 

The CSA and its implementing 

regulations are designed to prevent, 

detect, and eliminate the diversion of 

controlled substances and listed 

chemicals into the illicit market while 

providing for legitimate medical, 

scientific, research, and industrial needs 

of the United States. Controlled 

substances have the potential for abuse 

and dependence and are controlled to 

protect the public health and safety. 

Under the CSA, controlled substances 

are classified into 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 established by Congress are 

found at 21 U.S.C. 812(c), and the 

current list of all scheduled substances 

is published at 21 CFR part 1308. 

Pursuant to 21 U.S.C. 811(a)(1), the 

Attorney General may, by rule, ‘‘add to 

such a schedule or transfer between 

such schedules any drug or other 

substance if he (A) finds that such drug 

or other substance has a potential for 

abuse, and (B) makes with respect to 

such drug or other substance the 

findings prescribed by [21 U.S.C. 812(b)] 

for the schedule in which such drug is 

to be placed . . . .’’ Pursuant to 28 CFR 

0.100(b), the Attorney General has 

delegated this scheduling authority to 

the Administrator of the DEA who has 

further delegated this authority to the 

Deputy Administrator of the DEA under 

28 CFR 0.104. 

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); or (3) on 

the petition of any interested party. 21 

U.S.C. 811(a). If finalized, this action 

would impose the regulatory controls 

and administrative, civil, and criminal 

sanctions of Schedule III on the 

manufacture, distribution, dispensing, 

importation, exportation, research, 

instructional activities, and possession 

of perampanel. 

Background 

Perampanel [2-(2-oxo-1-phenyl-5- 

pyridin-2-yl-1,2-dihydropyridin-3-yl) 

benzonitrile hydrate] is a new chemical 

entity with central nervous system 

(CNS) depressant and hallucinogenic 

properties. The HHS states that on 

October 22, 2012, the Food and Drug 

Administration (FDA) approved a new 

drug application for perampanel as an 

adjunctive therapy for the treatment of 

partial-onset seizures with or without 

secondarily generalized seizures in 

patients with epilepsy aged 12 years and 

older. Perampanel will initially be 

marketed in the United States under the 

trade name FYCOMPA®. Perampanel is 

a non-competitive AMPA (a-amino-3- 

hydroxy-5-methyl-4-isoxazolepropionic 

acid)-type glutamate receptor 

antagonist. Perampanel was approved in 

Europe in May 2012 and has been 

marketed there since July 2012. 

Proposed Determination to Schedule 

Perampanel 

Pursuant to 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 the Department of Health and Human 

Services (HHS). On January 22, 2013, 

the HHS recommended that the DEA 

add perampanel to Schedule III of the 

CSA and provided the DEA with the 

scientific and medical evaluation 

document, ‘‘Basis for the 

Recommendation for Control of 

Perampanel and Its Salts in Schedule III 

of the Controlled Substances Act.’’ 

Following consideration of the eight 

factors determinative of control under 

the CSA, with findings related to the 

substance’s abuse potential, legitimate 

medical use, and dependence liability, 

the HHS recommended that perampanel 

be controlled in Schedule III of the CSA. 

In response, the DEA reviewed the 

scientific and medical evaluation and 

scheduling recommendation provided 

by the HHS, and all other relevant data, 

and completed an eight factor review 

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

Included below is a brief summary of 

each factor as analyzed by the HHS and 

the DEA, and as considered by the DEA 

in its proposed scheduling decision. 

Please note that the DEA and HHS 

analyses are available in their entirety 

under ‘‘Supporting and Related 

Material’’ in the public docket for this 

proposed rule, at http:// 

www.regulations.gov, under Docket 

Number ‘‘DEA–374.’’ Full analysis of, 

and citations to, the information 

referenced in the summary may also be 

found in the supporting and related 

material. 

1. The Drug’s Actual or Relative 

Potential for Abuse: Perampanel is a 

new chemical entity that has been 

marketed in Europe since July 2012. 

According to the HHS, since 

perampanel has been marketed in 

Europe only since July 2012, there is a 

lack of information regarding 

perampanel’s actual or relative potential 

for abuse. However, the legislative 

history of the CSA offers the following 

criterion for assessing a new 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 


tkelley on DSK3SPTVN1PROD with PROPOSALS
62502 Federal Register / Vol. 78, No. 204 / Tuesday, October 22, 2013 / Proposed Rules 

1Comprehensive Drug Abuse Prevention and 

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

Cong., Sess. 1 (1970); as reprinted in 1970 

U.S.C.C.A.N. 4566, 4601. 

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.1

According to the HHS, perampanel is 

a non-competitive AMPA-type 

glutamate receptor antagonist, which 

has been demonstrated by various 

groups. Antagonism of the AMPA 

receptors has been shown to produce a 

broad-spectrum anti-convulsant activity 

of focal and generalized epilepsy in 

animal models. 

The HHS states that monkeys selfadministered perampanel at rates 

similar to or greater than those for 

pentobarbital (Schedule II). These data 

indicate that perampanel may have a 

high psychological dependence liability. 

It was demonstrated in rats that 

cessation of administration of 

perampanel produced withdrawal 

symptoms similar to those produced 

after cessation of diazepam (Schedule 

IV) administration. 

According to the HHS, a clinical 

study of recreational drug abusers (with 

histories of abuse of sedative hypnotic 

and psychoactive drugs such as 

ketamine (Schedule III) and alprazolam 

(Schedule IV)) using ketamine 

(Schedule III), alprazolam (Schedule 

IV), and perampanel produced 

subjective effects indicative of abuse 

potential. The subjective effects 

reported were ‘‘euphoria,’’ ‘‘high,’’ and 

‘‘drug-liking.’’ For the measures of 

‘‘floating,’’ ‘‘spaced out,’’ and 

‘‘detached,’’ perampanel produced 

similar responses to those of ketamine 

(Schedule III) and greater responses 

than those of alprazolam (Schedule IV). 

The study used 8, 24, and 36 mg doses 

of perampanel, 100 mg doses of 

ketamine (Schedule III), 1.5 and 3mg 

doses of alprazolam (Schedule IV), or a 

placebo. Those that received 24 and 36 

mg doses of perampanel reported 

measures of ‘‘sedation,’’ ‘‘slowed 

down,’’ ‘‘confused,’’ ‘‘clear crisp 

vision,’’ and ‘‘attention span’’ at levels 

similar to or greater than alprazolam 

(Schedule IV) and greater than ketamine 

(Schedule III). Forty-six percent of the 

subjects reported euphoria-type adverse 

events (AEs) with the 24 and 36 mg 

perampanel doses, which was higher 

than the rate reported for 3 mg 

alprazolam (Schedule IV) (13 percent), 

and lower than that reported for 100 mg 

ketamine (Schedule III) (89 percent). 

The data from the study indicated that 

perampanel produces behavioral and 

subjective effects in humans similar to 

or greater than alprazolam (Schedule IV) 

and similar to ketamine (Schedule III). 

According to the HHS, based on 

results from the clinical study with 

recreational drug users, it is reasonable 

to assume that perampanel will appeal 

to individuals who prefer to abuse drugs 

that elicit the subjective and behavioral 

effects of alprazolam (Schedule IV) and 

ketamine (Schedule III). The HHS 

anticipates that abuse will result in: 

diversions of perampanel from 

legitimate pharmaceutical distribution 

channels; significant use of perampanel 

contrary to or without medical advice; 

and a substantial capability to create 

hazards to the abuser’s health and to the 

safety of the community. 

2. Scientific Evidence of the Drug’s 

Pharmacological Effects, If Known: 

Perampanel is a non-competitive 

antagonist of the AMPA glutamate 

receptor. According to the HHS, 

perampanel is also a direct and indirect 

antagonist of the NMDA receptor. The 

HHS states that perampanel is 

pharmacologically similar to ketamine 

(Schedule III), a NMDA receptor 

antagonist and a recreational drug 

known for its euphorigenic, 

dissociative, and hallucinogenic 

properties. Binding studies revealed that 

perampanel did not inhibit binding at 

any receptor site by more than 50 

percent. 

According to the HHS, based on 

electrophysiological assays performed 

on ion channels of GABAA receptors, 

perampanel would be expected to cause 

sedation, muscle relaxation, impairment 

of motor coordination and memory, 

development of dependency, and 

occurrence of benzodiazepine-like 

withdrawal symptoms after 

discontinuation. 

The DEA further adds that 

perampanel has inhibited AMPAinduced increases in [Ca2+]i in rat 

cortical neurons in a concentrationdependent manner, with an IC50 of 93 

nM. Perampanel (300 nM) inhibited 

AMPA receptor-mediated excitatory 

postsynaptic field potentials (f-EPSPs) 

in rat hippocampal slices by 50 percent. 

Perampanel inhibited AMPA receptormediated f-EPSPs in a dose-dependent 

manner, with 10 mM causing complete 

inhibition; the IC50 was 230 nM. 

According to the HHS, animal studies 

indicate that perampanel is a 

depressant. The Irwin test is an 

observational procedure that assesses 

and scores the effects of drugs on 

rodents’ behavior and physiology. 

Perampanel (5 mg/kg), administered 

orally by gavage, decreased alertness, 

touch response, body position, limb 

tone, grip strength, body tone, 

spontaneous activity, and abdominal 

tone, and caused staggering and 

inhibition of palpebral opening (eyelid) 

in male rats. 

The HHS reported on two human 

abuse potential studies that were 

performed in healthy, adult, recreational 

poly-drug users. In the first study, eight 

doses of perampanel (8, 12, 16, 20, 24, 

28, 32, and 36 mg) were administered to 

the subjects. It was determined that 36 

mg was the maximum tolerated dose 

(MTD). The most commonly reported 

AEs were psychiatric, in particular 

euphoria, which occurred at a rate of 

22.6 percent in the higher dose group 

which received 24, 28, 32, and 36 mg 

doses of perampanel. 

In the second human abuse potential 

study, perampanel produced subjective 

responses similar to or greater than 

those produced by alprazolam 

(Schedule IV) and ketamine (Schedule 

III). Perampanel (8, 24, and 36 mg), 

ketamine (Schedule III) (100 mg), 

alprazolam (Schedule IV) (1.5 and 3 

mg), and placebo were administered to 

34 subjects who were current 

recreational poly-drug users with 

histories of CNS depressant and 

psychedelic drug use. The effects of 

perampanel (24 and 36 mg) on the drugliking Visual Analogue Scale (VAS) 

were higher than that of alprazolam 

(Schedule IV) (1.5 and 3 mg) and similar 

to ketamine (Schedule III) (100 mg). For 

the Addiction Research Center 

Inventory Morphine-Benzedrine Group 

(ARCI MBG) (euphoria) measure, the 

responses produced by perampanel (24 

and 36 mg) were comparable to those 

produced by alprazolam (Schedule IV) 

(3 mg) and ketamine (Schedule III) (100 

mg), indicating that perampanel 

produces euphoria comparable to that 

produced by alprazolam (Schedule IV) 

and ketamine (Schedule III). The rates 

reported for euphoria AEs were 37 

percent for the 8 mg dose and 46 

percent for the 24 and 36 mg doses of 

perampanel. The rates reported for 

euphoria AEs for 3 mg alprazolam 

(Schedule IV) and 100 mg ketamine 

(Schedule III), were 13 percent and 89 

percent, respectively. 

For the measure of feeling ‘‘high’’ on 

a VAS, perampanel (24 and 36 mg) 

produced responses that were 

comparable to those for ketamine 

(Schedule III) (100 mg) and alprazolam 

(Schedule IV) (1.5 and 3 mg). 

Perampanel (36 mg) was long-acting for 

the sedation and ‘‘high’’ effects. They 

lasted at least 22 hours. It was 

demonstrated that perampanel caused 


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NMDA-antagonist specific effects, such 

as ‘‘floating,’’ ‘‘spaced out,’’ ‘‘detached,’’ 

and ‘‘feeling happy,’’ that were similar 

to those of ketamine (Schedule III) and 

greater than those of alprazolam 

(Schedule IV) (1.5 and 3 mg). The 

duration of these effects was longer for 

perampanel (24 and 36 mg) than for 

ketamine (Schedule III) (100 mg): 24 to 

48 hours compared to 3 hours, 

respectively. The measures of 

‘‘sedation,’’ ‘‘confused,’’ ‘‘slowed 

down,’’ ‘‘attention span,’’ and ‘‘clear 

crisp vision’’ following doses of 24 and 

36 mg perampanel were similar to, or 

greater than, alprazolam (Schedule IV), 

and greater than ketamine (Schedule 

III). The duration of effects of higher 

doses of perampanel on the majority of 

measures was longer than for 3 mg 

alprazolam (Schedule IV) and 100 mg 

ketamine (Schedule III). 

According to the HHS, in clinical 

trials that were conducted to study the 

effect of perampanel on certain chronic 

diseases, e.g., epilepsy, Parkinson’s 

disease, migraines, multiple sclerosis 

(MS), and peripheral neuropathy, 

perampanel caused CNS depressant 

effects including somnolence/sedation, 

dizziness, ataxia, confusion, amnesia 

and memory impairment, euphoria, 

depression, and suicidality. The AEs 

that are related to NMDA receptor 

antagonists were also associated with 

perampanel. These included psychotic 

disorder/psychosis, hallucinations, 

dissociation, delusional behavior, 

delirium, paranoia, euphoria, agitation, 

amnesia, confusion, and catatonia. 

3. The State of Current Scientific 

Knowledge Regarding the Drug or Other 

Substance: Perampanel (2-(2-oxo-1- 

phenyl-5-pyridin-2-yl-1,2- 

dihydropyridin-3-yl)benzonitrile 

hydrate (4:3) is a white-to-yellowish 

powder. The molecular formula is 

C23H15N3O • 3/4H2O. It is freely soluble 

in N-methylpyrrolidone, sparingly 

soluble in acetonitrile and acetone, 

slightly soluble in methanol, ethanol, 

and ethyl acetate, very slightly soluble 

in 1-octanol and diethyl ether, and 

practically insoluble in heptanes and 

water. 

Perampanel is rapidly and almost 

completely absorbed, slowly 

metabolized, and slowly eliminated 

after oral administration. In humans, the 

median Tmax ranged from 0.5–2.5 hours 

under fasted conditions; the Tmax

increased by 2–3 hours under fed 

conditions. Tmax is the amount of time 

for a substance to reach maximal plasma 

concentrations after administration. 

According to the HHS, the mean halflife of perampanel (1 mg) in the fasted 

state was 84.5 and 129.5 hours for men 

and women, respectively. The steady 

state is reached in about 2–3 weeks. 

Perampanel is slowly metabolized and 

the metabolites are eliminated rapidly 

via urine or feces. Three metabolites of 

perampanel have been identified as 

HU1, HU2, and HU3. HU1 and HU2 are 

oxygen glucuronide conjugates and HU3 

is a dihydrodiol analog. Oxidative 

metabolism is mediated by CYP3A4 

and/or CYP3A5. 

4. Its History and Current Pattern of 

Abuse: An assessment of the history and 

current pattern of perampanel abuse is 

not available because it has only been 

marketed in Europe since July 2012. As 

stated in HHS’s review, the results of a 

human abuse potential study indicate 

that perampanel has an abuse potential 

comparable to or greater than the abuse 

potential of alprazolam (Schedule IV) 

and similar to that of ketamine 

(Schedule III). In addition, higher doses 

of perampanel produced a high rate of 

euphoria-type AEs (up to 46 percent). 

The HHS asserts that the positive 

subjective effects reported from 

supratherapeutic doses of perampanel 

administration are predictive of its 

potential to be abused. Alprazolam 

(Schedule IV) and ketamine (Schedule 

III) have histories of diversion and 

abuse. Based on perampanel’s subjective 

AE profile and its similarity to ketamine 

(Schedule III) and alprazolam (Schedule 

IV), it is reasonable to assume that 

perampanel will produce an abuse 

pattern that will have features of both 

ketamine (Schedule III) and alprazolam 

(Schedule IV) abuse. 

5. The Scope, Duration, and 

Significance of Abuse: According to the 

HHS review, the scope, duration, and 

significance of abuse of perampanel are 

unknown because it has only been 

marketed in Europe since July 2012. 

However, the scope, duration, and 

significance of abuse of perampanel can 

be predicted from the data obtained in 

pre-market clinical studies such as 

abuse potential studies and other 

clinical studies. In its analysis, the HHS 

concluded that: 

[I]f perampanel were marketed in the United 

States, the scope and significance of abuse of 

perampanel would be similar to or greater 

than alprazolam [Schedule IV] and similar to 

or greater than ketamine [Schedule III]. If 

perampanel were marketed as a noncontrolled antiepileptic drug, it is reasonable 

to assume that perampanel would be abused 

to an even greater extent than it would be 

when controlled in Schedule III of the CSA. 

This is because individuals who abuse such 

drugs, namely ketamine, would likely prefer 

to use a drug that is non-controlled, or in a 

lower level of control, rather than drugs that 

act similarly and are controlled in [Schedule 

III], or more restrictive schedules of the CSA. 

6. What, if Any, Risk There Is to the 

Public Health: According to HHS, 

perampanel likely poses a risk to public 

health similar to or greater than that of 

alprazolam (Schedule IV) and similar to 

that of ketamine (Schedule III). The 

HHS asserts that the ability of a drug to 

have an abuse potential is an indication 

of the public health risk associated with 

the drug. As summarized in Factor 2, 

supratherapeutic doses of perampanel 

(24 and 36 mg) produced euphoria-type 

AEs in 46 percent of subjects, which 

was greater than the rate of euphoria 

AEs in subjects given 3 mg alprazolam 

(Schedule IV) (13 percent) and less than 

that produced by 100 mg ketamine 

(Schedule III) (89 percent). 

Clinical studies have demonstrated 

that perampanel does affect 

psychomotor performance. In a study of 

healthy volunteers, single and multiple 

doses of 8 and 12 mg perampanel dosedependently impaired psychomotor 

performance. In the same study, healthy 

volunteers were given alcohol until 

their alcohol blood level reached 80– 

100 mg/100 ml, in addition to 

perampanel. The effects of perampanel 

on complex tasks, such as driving 

ability, were additive or supra-additive 

to the impairment effects of alcohol. 

According to the HHS, the risk of 

perampanel to the public health was 

demonstrated by the AEs of aggression, 

anger, hostility, suicidal ideation and 

attempts, and homicidal ideation and 

threats associated with perampanel 

during the clinical trials. The 

FYCOMPA® drug label includes a boxed 

warning alerting prescribers and 

ultimate users to these public health 

risks. Approximately 50 subjects from 

the clinical trials, without previous 

relevant psychiatric histories, developed 

psychotic disorders, such as paranoia, 

delusion, delirium, schizophrenia, and 

catatonia while taking perampanel. This 

indicates that perampanel may cause 

users to display unpredictable or 

aggressive behavior towards themselves 

or others. Based on the AEs of 

perampanel summarized above, the 

HHS determined that the public health 

risks of perampanel are likely to be 

similar to other CNS drugs, such as 

ketamine (Schedule III). 

7. Its Psychic or Physiological 

Dependence Liability: According to the 

HHS, low (up to 14.7 mg/kg) and high 

doses (up to 43.5 mg/kg) of oral 

perampanel were administered to rats 

for 4 weeks, followed by a 1-week 

withdrawal period. During the 

withdrawal period, the rats displayed 

withdrawal symptoms indicative of 

dependence, such as hyper-reactivity 

and muscle rigidity, along with reduced 

food consumption. 

According to the HHS, the physical 

dependence of perampanel in humans 


tkelley on DSK3SPTVN1PROD with PROPOSALS
62504 Federal Register / Vol. 78, No. 204 / Tuesday, October 22, 2013 / Proposed Rules 

has not been fully evaluated, because in 

Phase 3 clinical trials, symptoms of 

withdrawal were collected in only a 

small fraction of patients. Reported 

withdrawal symptoms included fatigue/ 

lethargy/asthenia, irritability, anxiety/ 

nervousness, worsening of mood/ 

tearfulness, mood swings, sleep 

disorders, weight changes, changes in 

appetite, muscle pain/stiffness, 

diarrhea/nausea/vomiting, rhinorrhea, 

lacrimation, headache, dizziness, 

hallucinations, panic, and craving/drug 

seeking. The HHS asserts that the 

limited results demonstrate that 

discontinuation of perampanel 

administration causes signs and 

symptoms of withdrawal. 

8. Whether the Substance Is an 

Immediate Precursor of a Substance 

Already Controlled Under the CSA: 

Perampanel 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 the HHS and its 

recommendation, and after considering 

its own eight-factor analysis, the DEA 

has determined that these facts and all 

relevant data constitute substantial 

evidence of potential for abuse of 

perampanel. As such, the DEA hereby 

proposes to schedule perampanel as a 

controlled substance under the CSA. 

Proposed Determination of Appropriate 

Schedule 

The CSA outlines the findings 

required to place a drug or other 

substance in any particular schedule (I, 

II, III, IV or V). 21 U.S.C. 812(b). After 

consideration of the analysis and 

recommendation by the Assistant 

Secretary for Health of the HHS, and 

review of all available data, the Deputy 

Administrator of the DEA, pursuant to 

21 U.S.C. 812(b)(3), finds that: 

1. Perampanel has a potential for 

abuse less than the drugs or other 

substances in Schedules I and II; 

2. Perampanel has a currently 

accepted medical use in treatment in the 

United States. Perampanel was 

approved for marketing by the FDA as 

an adjunctive treatment of partial-onset 

seizures with or without secondarily 

generalized seizures in patients with 

epilepsy aged 12 years and older; and 

3. Abuse of perampanel may lead to 

moderate or low physical dependence 

or high psychological dependence. 

Based on these findings, the Deputy 

Administrator of the DEA concludes 

that perampanel [2-(2-oxo-1-phenyl-5- 

pyridin-2-yl-1,2-dihydropyridin-3-yl) 

benzonitrile hydrate], including its salts, 

isomers, and salts of isomers, warrants 

control in Schedule III of the CSA. 21 

U.S.C. 812(b)(3). 

Requirements for Handling Perampanel 

If this rule is finalized as proposed, 

perampanel would be subject to the 

CSA’s Schedule III regulatory controls 

and administrative, civil, and criminal 

sanctions applicable to the manufacture, 

distribution, dispensing, importing, 

exporting, research, and conduct of 

instructional activities, including the 

following: 

Registration. Any person who handles 

(manufactures, distributes, dispenses, 

imports, exports, engages in research, or 

conducts instructional activities) 

perampanel, or who desires to handle 

perampanel, would be required to be 

registered with the DEA to conduct such 

activities, pursuant to 21 U.S.C. 822, 

823, 957, and 958, and in accordance 

with 21 CFR parts 1301 and 1312. Any 

person who handles perampanel, and is 

not registered with the DEA, must be 

registered with the DEA to conduct such 

activities pursuant to 21 U.S.C. 822, 

823, 957, and 958, and in accordance 

with 21 CFR parts 1301 and 1312. Any 

person who handles perampanel, and is 

not registered with the DEA, would 

need to be registered with the DEA to 

conduct such activities by the effective 

date of the final rule. 

Security. Perampanel would be 

subject to Schedule III–V security 

requirements and would need to be 

handled and stored in accordance with 

21 CFR 1301.71–1301.93, pursuant to 21 

U.S.C. 823, 821, 871(b). 

Labeling and Packaging. All labels 

and labeling for commercial containers 

of perampanel 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, 

958(e). 

Inventory. Every DEA registrant who 

possesses any quantity of perampanel 

on the effective date of the final rule 

would be required to take an inventory 

of all stocks of perampanel on hand as 

of the effective date of the rule, pursuant 

to 21 U.S.C. 827, 958(e) and in 

accordance with 21 CFR 1304.03, 

1304.04, and 1304.11(a) and (d). 

Any person who becomes registered 

with the DEA after the effective date of 

the final rule would be required to take 

an initial inventory of all stocks of 

controlled substances (including 

perampanel) on hand at the time of 

registration pursuant to 21 U.S.C. 827, 

958(e), and in accordance with 21 CFR 

1304.03, 1304.04, and 1304.11(a) and 

(b). After the initial inventory, every 

DEA registrant would be required to 

take a biennial inventory of all 

controlled substances (including 

perampanel) on hand, on a biennial 

basis, pursuant to 21 U.S.C. 827, 958(e) 

and in accordance with 21 CFR 1304.03, 

1304.04, and 1304.11. 

Records. All DEA registrants would be 

required to maintain records of 

perampanel pursuant to 21 U.S.C. 827, 

958(e) and in accordance with 21 CFR 

parts 1304 and 1312. 

Prescriptions. All prescriptions for 

perampanel or prescriptions for 

products containing perampanel would 

be required to be issued pursuant to 21 

U.S.C. 829 and in accordance with 21 

CFR part 1306. 

Importation and Exportation. All 

importation and exportation of 

perampanel would need to be done in 

accordance with 21 CFR part 1312, 

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

958. 

Liability. Any activity with 

perampanel not authorized by, or in 

violation of, the CSA, occurring on or 

after finalization of this proposed rule, 

would be unlawful, and may subject the 

person to administrative, civil, and/or 

criminal sanctions. 

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 

performed ‘‘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 procedures and criteria for 

scheduling a drug or other substance. 

Such actions are exempt from review by 

the Office of Management and Budget 

(OMB) 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 drafting errors and ambiguity, 

minimize litigation, provide a clear legal 

standard for affected conduct, and 

promote simplification and burden 

reduction. 

Executive Order 13132 

This proposed rulemaking does not 

have federalism implications warranting 

the application of Executive Order 

13132. The proposed 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. 


tkelley on DSK3SPTVN1PROD with PROPOSALS
Federal Register / Vol. 78, No. 204 / Tuesday, October 22, 2013 / Proposed Rules 62505 

Executive Order 13175 

This proposed rule does not have 

tribal implications warranting the 

application of Executive Order 13175. It 

does not have substantial direct effects 

on one or more Indian tribes, on the 

relationship between the Federal 

Government and Indian tribes, or on the 

distribution of power and 

responsibilities between the Federal 

Government and Indian tribes. 

Regulatory Flexibility Act 

The Deputy Administrator, in 

accordance with the Regulatory 

Flexibility Act (RFA) (5 U.S.C. 601– 

612), has reviewed this proposed 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 proposed 

rule is to place perampanel, including 

its salts, isomers, and salts of isomers, 

into Schedule III of the CSA. No less 

restrictive measures (i.e., non-control) 

enable the DEA to meet its statutory 

obligations under the CSA. In preparing 

this certification, the DEA has assessed 

economic impact by size category and 

has considered costs with respect to the 

various DEA registrant business activity 

classes. 

Perampanel is a new molecular entity, 

approved by the FDA on October 22, 

2012. It was approved in Europe in May 

2012, and has been marketed in Europe 

since July 2012. According to publicly 

available information reviewed by the 

DEA, perampanel is currently 

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 

perampanel is extremely small. The 

publicly available materials also specify 

the readily identifiable persons subject 

to direct regulation by this proposed 

rule. Based on guidelines utilized by the 

Small Business Administration, the 

perampanel manufacturer/distributor/ 

importer was determined not to be a 

small entity. Once generic equivalents 

are developed and approved for 

manufacturing and marketing, there 

may be additional manufacturers, 

importers, and distributors of 

perampanel, but whether they may 

qualify as small entities cannot be 

determined at this time. 

There are approximately 1.5 million 

controlled substance registrants, 

approximately 381,559 of which are 

estimated to be businesses. The DEA 

estimates that 371,588 (97 percent) of 

the affected businesses are considered 

‘‘small entities’’ in accordance with the 

RFA and Small Business Administration 

(SBA) 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 could 

potentially influence the dispensing 

rates of new chemical entities, the DEA 

is unable to determine the number of 

small entities that might dispense 

(including administer and prescribe) 

perampanel (e.g., pharmacies and 

prescribers). 

Despite the fact that the number of 

small businesses potentially impacted 

by this proposed rule could not be 

determined at this time, the DEA 

concludes that they would not 

experience a significant economic 

impact as a result of this rule. Currently, 

98 percent of DEA registrants (most of 

which are small businesses) are 

authorized to handle Schedule III 

controlled substances. Even if we 

assume that all of the DEA registrants 

were to dispense perampanel, (e.g., 

practitioners prescribe, administer, or 

dispense the substance, and pharmacies 

dispense the prescriptions), the costs 

that they would incur as a result of 

perampanel scheduling would be 

minimal. Registrants that dispense (but 

not prescribe) would incur nominal 

additional security, inventory, 

recordkeeping, and labeling costs, as 

they have already established and 

implemented the required systems and 

processes to handle Schedule III 

controlled substances. For example, 

pharmacies and institutional 

practitioners may disperse Schedule II 

through V controlled substances 

throughout their stock of non-controlled 

substances in such a manner as to 

obstruct theft or diversion of the 

controlled substances. The inclusion of 

one additional substance to this system 

would result in little or no additional 

burden to such practitioners. In 

addition, because DEA-registered 

dispensers must label all Schedule II–V 

controlled substances dispensed, the 

requirement to label all controlled 

substances containing perampanel 

would not impose a significant 

economic burden upon DEA-registered 

dispensers (as the infrastructure and 

materials for doing so would already be 

in place). Accordingly, compliance 

would not require significant 

manpower, capital investments, or 

recordkeeping burdens. 

Registrants who only prescribe 

perampanel by oral or written 

prescription would not incur any 

additional security, inventory, 

recordkeeping, or labeling costs as a 

result of this rule as they would not 

physically handle perampanel. 

Because of these facts, this proposed 

rule will not result in significant 

economic impact on a substantial 

number of small entities. 

Unfunded Mandates Reform Act of 

1995 

In accordance with the Unfunded 

Mandates Reform Act (UMRA) of 1995 

(2 U.S.C. 1501 et seq.), on the basis of 

information contained in the 

‘‘Regulatory Flexibility Act’’ section 

above, the DEA has determined and 

certifies pursuant to UMRA that this 

action would not result in any federal 

mandate that may result ‘‘in the 

expenditure by State, local, and tribal 

governments, in the aggregate, or by the 

private sector, of $100,000,000 or more 

(adjusted for inflation) in any one year. 

. . .’’ Therefore, neither a Small 

Government Agency Plan nor any other 

action is required under provisions of 

UMRA of 1995. 

Paperwork Reduction Act of 1995 

This action does not impose a new 

collection of information requirement 

under the Paperwork Reduction Act of 

1995 (44 U.S.C. 3501–3521). This action 

would not impose recordkeeping or 

reporting requirements on State or local 

governments, individuals, businesses, or 

organizations. An agency may not 

conduct or sponsor, and a person is not 

required to respond to, a collection of 

information unless it displays a 

currently valid OMB control number. 

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 21 CFR 

part 1308 continues to read as follows: 

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

unless otherwise noted. 

■ 2. Amend § 1308.13 by redesignating 

paragraphs (c)(11) through (c)(14) as 

paragraphs (c)(12) through (c)(15) and 

adding new paragraph (c)(11) to read as 

follows: 

§ 1308.13 Schedule III. 

* * * * * 

(c) * * * 

(11) Perampanel, and its salts, 

isomers, and salts of isomers 2261 

* * * * * 


tkelley on DSK3SPTVN1PROD with PROPOSALS
62506 Federal Register / Vol. 78, No. 204 / Tuesday, October 22, 2013 / Proposed Rules 

Dated: October 9, 2013. 

Thomas M. Harrigan, 

Deputy Administrator. 

[FR Doc. 2013–24600 Filed 10–21–13; 8:45 am] 

BILLING CODE P 

DEPARTMENT OF DEFENSE 

Office of the Secretary 

32 CFR Part 199 

[DOD–2013–HA–0164] 

RIN 0720–AB61 

TRICARE; Coverage of Care Related to 

Non-Covered Initial Surgery or 

Treatment 

AGENCY: Office of the Secretary, 

Department of Defense. 

ACTION: Proposed rule. 

SUMMARY: The Department of Defense 

(DoD) is publishing this proposed rule 

to allow coverage for otherwise covered 

services and supplies required in the 

treatment of complications (unfortunate 

sequelae), as well as medically 

necessary and appropriate follow-on 

care, resulting from a non-covered 

incident of treatment provided pursuant 

to a properly granted Supplemental 

Health Care Program waiver. This 

proposed rule is necessary to protect 

TRICARE beneficiaries from incurring 

financial hardships due to the current 

regulatory restrictions that prohibit 

TRICARE coverage of the treatment of 

complications resulting from noncovered medical procedures, even when 

those procedures were provided while 

the beneficiary was an active duty 

member and were authorized by the 

Director, TRICARE Management 

Activity (TMA), based on a 

determination that a waiver authorizing 

the original non-covered surgery or 

treatment was necessary to assure 

adequate availability of health care to 

the Active Duty member. Additionally, 

with respect to care that is related to a 

non-covered initial surgery or treatment, 

the proposed rule seeks to eliminate any 

confusion regarding what services and 

supplies will be covered by TRICARE 

and under what circumstances they will 

be covered. 

DATES: Comments must be received on 

or before December 23, 2013. Do not 

submit comments directly to the point 

of contact or mail your comments to any 

address other than what is shown 

below. Doing so will delay the posting 

of the submission. 

ADDRESSES: You may submit comments, 

identified by docket number and/or 

Regulatory Identification Number (RIN) 

and title, by any of the following 

methods: 

• Federal eRulemaking Portal: http:// 

www.regulations.gov. Follow the 

instructions for submitting comments. 

• Mail: Federal Docket Management 

System Office, 4800 Mark Center Drive, 

East Tower, Suite 02G09, Alexandria, 

VA 22350–3100. 

Instructions: All submissions received 

must include the agency name and 

docket number or RIN for this Federal 

Register document. The general policy 

for comments and other submissions 

from members of the public is to make 

these submissions available for public 

viewing on the Internet at http://

regulations.gov as they are received 

without change, including any personal 

identifiers or contact information. 

FOR FURTHER INFORMATION CONTACT: 

Thomas Doss (703) 681–7512. 

SUPPLEMENTARY INFORMATION: 

I. Executive Summary 

1. Purpose of Regulatory Actions 

a. Need for Regulatory Actions 

Under the TRICARE private sector 

health care program, certain conditions 

and treatments are excluded from 

coverage. For example, any drug, 

device, medical treatment, or procedure 

whose safety and efficacy has not been 

established by reliable evidence is 

considered unproven and excluded 

from coverage. This exclusion includes 

all services directly related to the 

unproven drug, device, medical 

treatment or procedure. Specifically, 

benefits for otherwise covered services 

and supplies that are required in the 

treatment of complications (unfortunate 

sequelae) resulting from a non-covered 

incident of treatment, are generally 

excluded from TRICARE coverage 

pursuant to title 32 of the Code of 

Federal Regulation (CFR) section 

199.4(e)(9), unless the complication 

represents a separate medical condition 

such as a systemic infection, cardiac 

arrest, and acute drug reaction. 

TRICARE also excludes any needed 

follow-on care resulting from a noncovered condition or initial surgery or 

treatment pursuant to § 199.4(g)(63). 

There is currently one exception to 

this general exclusion, published in the 

Federal Register [76 FR 57642] on 

September 16, 2011, to allow coverage 

of otherwise covered services and 

supplies required in the treatment of 

complications (unfortunate sequelae) 

resulting from a non-covered incident of 

treatment provided in a Military 

Treatment Facility (MTF), when the 

initial non-covered service has been 

authorized by the MTF Commander and 

the MTF is unable to provide the 

necessary treatment of the 

complications. This current exception 

recognizes that in order to support 

Graduate Medical Education and 

maintain provider skill levels, MTF 

providers are required to perform 

medical procedures that may be 

excluded from coverage under the 

TRICARE private sector program. The 

final rule at 32 CFR199.4(e)(9)(ii) was 

viewed as necessary to protect TRICARE 

beneficiaries from incurring financial 

hardships in such cases. 

Currently, Active Duty Service 

members (ADSMs) may receive noncovered TRICARE private sector health 

care services under the Supplemental 

Health Care Program (SHCP) if a waiver 

is submitted through the Service and 

approved by the Director, TMA, or 

designee, in accordance with § 199.6(f). 

While the Department wants to ensure 

that Service members have access to the 

latest, promising medical technologies 

and procedures, there must be assurance 

that the care is safe and effective, and 

that members are not subjected to undue 

risk, or rendered unfit for continued 

service, due to complications suffered as 

a result of unproven medical care. 

Consequently, requests for non-covered 

procedures and treatments, including 

unproven care, are carefully reviewed in 

conjunction with other available, 

proven treatments, if any exist, to 

determine whether or not approval of 

the requested care is necessary to assure 

the adequate availability of health care 

to the member. Currently, Service 

members are counseled that the 

treatment remains a non-covered 

TRICARE benefit, and that any followon care, including care for 

complications, will not be covered by 

TRICARE once the member separates or 

retires. Members are left to make a 

difficult choice between pursuing a 

SHCP waiver in an effort to remain fit 

for full duty while assuming the 

financial risk of any necessary follow-on 

care after discharge, or, electing not to 

receive the care and risk separation from 

the Service. 

Like the existing exception at 32 

CFR199.4(e)(9)(ii) for non-covered care 

provided in a MTF, this proposed 

exception is narrowly tailored to serve 

a similar government interest; namely, 

protecting former active duty members 

who have received private sector care 

pursuant to a SHCP waiver in an effort 

to ensure their fitness for duty and 

continued service. 

Additionally, some confusion has 

arisen regarding the terms 

‘complication’’ and ‘‘unfortunate 

sequelae’’ as these terms are not 


tkelley on DSK3SPTVN1PROD with PROPOSALS