65424 Federal Register / Vol. 76, No. 204 / Friday, October 21, 2011 / Proposed Rules 

1 21 CFR 1300.01. 

concerning the accuracy of this burden and 

suggestions for reducing the burden should 

be directed to the FAA at: 800 Independence 

Ave., SW., Washington, DC 20591, Attn: 

Information Collection Clearance Officer, 

AES–200. 

Related Information 

(h) Refer to MCAI EASA AD No.: 2011– 

0146, dated August 3, 2011; Schempp-Hirth 

Flugzeugbau GmbH Technical Note No. 863– 

14, dated July 18, 2006; and Schempp-Hirth 

Flugzeugbau GmbH Technical Note No. 864– 

20 Revision 1, dated July 27, 2011, for related 

information. For service information related 

to this AD, contact Schempp-Hirth 

Flugzeugbau GmbH, Krebenstrasse 25, D– 

73230 Kirchheim/Teck, Germany; phone: +49 

7021 7298–0; fax +49 7021 7298–199; 

Internet: http://www.schempp-hirth.com; 

e-mail: info@schempp-hirth.com. You may 

review copies of the referenced service 

information at the FAA, Small Airplane 

Directorate, 901 Locust, Kansas City, 

Missouri 64106. For information on the 

availability of this material at the FAA, call 

(816) 329–4148. 

Issued in Kansas City, Missouri, on 

October 17, 2011. 

Earl Lawrence, 

Manager, Small Airplane Directorate, Aircraft 

Certification Service. 

[FR Doc. 2011–27267 Filed 10–20–11; 8:45 am] 

BILLING CODE 4910–13–P 

DEPARTMENT OF JUSTICE 

Drug Enforcement Administration 

21 CFR Part 1308 

[Docket No. DEA–354] 

Schedules of Controlled Substances: 

Placement of Ezogabine Into Schedule 

V 

AGENCY: Drug Enforcement 

Administration, Department of Justice. 

ACTION: Notice of proposed rulemaking. 

SUMMARY: The Drug Enforcement 

Administration (DEA) proposes placing 

the substance ezogabine, including its 

salts, isomers, and salts of isomers 

whenever the existence of such salts, 

isomers, and salts of isomers is possible, 

into Schedule V of the Controlled 

Substances Act (CSA). This proposed 

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: 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 November 21, 

2011. 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),’’ 1 may file a request for hearing 

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 

participation must be received on or 

before November 21, 2011. 

ADDRESSES: To ensure proper handling 

of comments, please reference ‘‘Docket 

No. DEA–354’’ 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 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 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 must 

be sent to Drug Enforcement 

Administration, Attention: Hearing 

Clerk/LJ, 8701 Morrissette Drive, 

Springfield, VA 22152. 

FOR FURTHER INFORMATION CONTACT: 

Rhea D. Moore, Office of Diversion 

Control, Drug Enforcement 

Administration, 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 of 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’’ paragraph. 

Request for Hearing, Notice of 

Appearance at 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)–(c), requests for hearing, 

notices of appearance, 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).’’ 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. A request or 

notice 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 


jlentini on DSK4TPTVN1PROD with PROPOSALS
Federal Register / Vol. 76, No. 204 / Friday, October 21, 2011 / Proposed Rules 65425 

2http://www.accessdata.fda.gov/ 

drugsatfda_docs/nda/2011/ 

022345Orig1s000TOC.cfm; as of July 21, 2011. 

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. 

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, notices of 

appearance at the hearing, and waivers 

of participation in the hearing should be 

submitted to DEA using the address 

information provided above. 

Legal Authority 

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 are 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 HHS, or (3) on the petition 

of any interested party. 21 U.S.C. 811(a). 

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 V on the manufacture, 

distribution, dispensing, importation, 

and exportation of ezogabine and 

products containing ezogabine. 

Background 

Ezogabine, known chemically as N-[2- 

amino-4-(4-fluorobenzylamino)-phenyl]- 

carbamic acid ethyl ester, is a new 

chemical substance with central 

nervous system depressant properties 

and is classified as a sedative-hypnotic. 

Pharmacological studies indicate that 

ezogabine primarily acts as a ligand at 

ion-gated channels in the brain to 

enhance potassium currents mediated 

by neuronal KCNQ (Kv7) channels. 

Additionally, ezogabine indirectly 

enhances the gamma-aminobutyric acid 

(GABA) mediated neurotransmission. 

On June 10, 2011, the Food and Drug 

Administration (FDA) approved a New 

Drug Application (NDA) for ezogabine 

as an adjunct treatment of partial onset 

seizures, to be marketed under the trade 

name Potiga.® 2

Proposed Determination to Schedule 

Ezogabine 

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 HHS. On January 12, 2011, HHS 

provided DEA with a scientific and 

medical evaluation document prepared 

by FDA entitled ‘‘Basis for the 

Recommendation for Control of 

Ezogabine in Schedule V of the 

Controlled Substances Act.’’ Pursuant to 

21 U.S.C. 811(b), this document 

contained an eight-factor analysis of the 

abuse potential of ezogabine as a new 

drug, along with HHS’ recommendation 

to control ezogabine under Schedule V 

of the CSA. 

In response, DEA conducted an eightfactor analysis of ezogabine’s abuse 

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

Included below is a brief summary of 

each factor as analyzed by HHS and 

DEA, and as considered by DEA in the 

scheduling decision. Please note that 

both the DEA and HHS analyses are 

available in their entirety under 

‘‘Supporting and Related Material’’ of 

the public docket for this rule at 

www.regulations.gov under docket 

number DEA–354. 

1. The Drug’s Actual or Relative 

Potential for Abuse: Ezogabine 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 ezogabine. 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

Ezogabine acts as a ligand at ion-gated 

channels in the brain, similar to the 

Schedule V substances pregabalin and 

lacosamide, and, like those drugs, 

ezogabine is indicated for the treatment 

of epileptic conditions in humans. 

There is strong evidence, described 

below, that ezogabine produces 

behavioral effects in humans and in 

animals that are similar to those 

produced by pregabalin and lacosamide. 

Phase 1 clinical studies indicate that 

the rate of euphoria-related adverse 

events (AEs) resulting from 

administration of ezogabine was 6–9%. 

This is similar to the AE rates for 

administration of pregabalin (10%) and 

lacosamide (>7%), while Phase 2⁄3

clinical studies indicated similar AE 

rates between ezogabine (<1%) and 

lacosamide (<2%). Animal studies 

involving administration of ezogabine to 

animals produced a sedative behavioral 

profile similar to that produced from 

administration of pregabalin and 

lacosamide, including decreased 

locomotion, decreased muscle tone, and 

an increase in ataxia. Further, in abuse 

potential studies conducted with 

sedative-hypnotic abusers, ezogabine, 

pregabalin, and lacosamide, when 

compared to placebos, are similar in 

their ability to produce statistically 

significant increases in subjective 

responses including ‘‘Drug Liking,’’ 

‘‘Euphoria,’’ ‘‘Overall Drug Liking,’’ 

‘‘Good Drug Effects,’’ and ‘‘High.’’ 

Because of the similarities between 

ezogabine, pregabalin, and lacosamide, 

it is very likely that ezogabine will have 

an abuse potential similar to those 

Schedule V substances. Currently there 

is a lack of evidence regarding the 

diversion, illicit manufacturing or 

deliberate misuse of ezogabine due to its 

commercial unavailability in any 

country, but since ezogabine is not 

readily synthesized from available 

substances, any diversion would be 

from legitimate channels. The above 

referenced studies, which include 

demonstration of the significant 

euphoric effects produced by ezogabine 

in humans, predict that there will be 

significant use of ezogabine contrary to 

or without medical advice. 

2. Scientific Evidence of the Drug’s 

Pharmacological Effects, If Known: 


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Ezogabine acts to enhance potassium 

currents mediated by neuronal KCNQ 

(Kv7) channels with a secondary action 

through the augmentation of GABAmediated neurotransmission without 

direct GABA receptor stimulation. In 

individuals with histories of 

recreational sedative-hypnotic abuse, 

ezogabine (300 and 600 mg orally) 

produced increased ratings on the 

primary positive subjective scales [VASDrug-liking, VAS-Overall Drug Liking, 

ARCI–MBG (Euphoria), VAS-Take Drug 

Again] for peak responses (Emax for the 

first eight hours after drug 

administration) that were significantly 

different from the placebo. This effect is 

similar to that produced by alprazolam 

(1.5 and 3.0 mg orally; Schedule IV). On 

secondary positive subjective scales 

[VAS-High, VAS-Good Effects, ARCIAmphetamine (Activation)] for peak 

responses, both ezogabine and 

alprazolam produced significant 

increases compared to the placebo, 

while there were no differences between 

ezogabine and alprazolam on those 

measures. 

In human abuse potential studies, 

ezogabine (300 and 600 mg), upon oral 

administration, increased ratings on 

negative and sedating subjective 

measures [VAS-Bad Effects, ARCI–LSD 

(dysphoria) and ARCI–PCAG (sedation)] 

compared to the placebo, but these 

increases were lower than those 

produced by 1.5 and 3.0 mg alprazolam. 

These data for ezogabine are similar to 

those produced by lacosamide. A 900 

mg dose of ezogabine produced VASDrug Liking and VAS-Good Effects that 

were higher than those produced by the 

two lower doses of ezogabine and either 

dose of alprazolam. However, the 

changes in VAS-Bad Effects and ARCI– 

LSD (dysphoria) following 900 mg 

ezogabine were less than or similar to 

those produced by lower doses of 

ezogabine and either dose of 

alprazolam. The adverse events 

following 900 mg ezogabine are similar 

to those described in the NDA for the 

human abuse potential study conducted 

with lacosamide. These included 

euphoria, somnolence, visual 

disturbances, and altered auditory 

perception. 

In human abuse potential studies, 

ezogabine, similar to pregabalin and 

lacosamide, also produced ratings on 

each of the positive subjective responses 

that were statistically similar to those 

produced by Schedule IV 

benzodiazepines (alprazolam or 

diazepam). Although this appears to 

suggest that these drugs have an abuse 

potential similar to that of Schedule IV 

substances, the other data from human 

abuse potential studies, the adverse 

effect profile data from safety and 

efficacy studies, and the data from the 

preclinical animal behavioral studies 

demonstrate that ezogabine has abuse 

potential less than that of Schedule IV 

drugs but similar to that of Schedule V 

drugs. 

3. The State of Current Scientific 

Knowledge Regarding the Drug or Other 

Substance: The chemical name of 

ezogabine is N-[2-amino-4-(4- 

fluorobenzylamino)-phenyl]-carbamic 

acid ethyl ester. It is an achiral molecule 

with a molecular formula of 

C16H18FN3O2 and a molecular weight of 

303.3 g/mol. Ezogabine is a nonhygroscopic white to slightly colored 

powder with a melting point of 140– 

1430C. It is soluble in 0.9% saline, 

methanol, chloroform, but only 

sparingly soluble in ethanol and 0.1N 

HCL. 

Ezogabine in humans has a Tmax (time 

required for ezogabine to reach 

maximum plasma concentration) 

ranging from 1–4 hours following both 

acute and multiple dosing, and, without 

the involvement of cytochrome P450, 

undergoes an extensive and almost 

exclusively phase 2 metabolic 

biotransformation. Ezogabine is 

predominantly metabolized by Nglucuronidation, resulting in the 

formation of two distinct Nglucuronides of the unchanged parent 

drug and to a lesser extent by Nacetylation to form N-acetyl-retigabine, 

the major bioactive metabolite of 

ezogabine. The half-life of both 

ezogabine and N-acetyl-retigabine is 

approximately eight hours and the Cmax

(maximum plasma concentration) of 

both components is dose proportional 

after both acute and multiple dosing, 

suggesting a lack of accumulation with 

repeated administration. 

4. Its History and Current Pattern of 

Abuse: As stated in the summary of 

Factor 1, information on ezogabine’s 

history and current pattern of abuse is 

unavailable as it has not been marketed 

in any country. As such, evaluation of 

abuse potential for ezogabine derives 

from positive indicators in clinical 

studies which are believed to be 

predictive of drug abuse and which are 

discussed in Factors 1 and 2 above. 

5. The Scope, Duration, and 

Significance of Abuse: Because 

ezogabine has not been marketed in any 

country, information on the scope, 

duration, and significance of abuse of 

ezogabine is unavailable. However, 

epidemiological data on pregabalin, a 

Schedule V drug with an abuse 

potential similar to that of ezogabine, is 

available from the Drug Abuse Warning 

Network (DAWN) database. 

The ‘‘abuse frequency ratio,’’ 

calculated as the ratio of nonmedical 

use related annual emergency 

department visits (as reported in 

DAWN) to the total number of annual 

prescriptions for pregabalin is less than 

that for the Schedule IV drug, 

alprazolam. Further, because ezogabine 

has abuse-related human and animal 

data in its NDA similar to data 

generated for pregabalin, ezogabine is 

likely to have an abuse potential similar 

to pregabalin. The ‘‘abuse frequency 

ratios’’ for pregabalin range from 29 to 

47, while those for alprazolam are 

approximately three to six times higher, 

ranging from 160 to 235. Thus, 

pregabalin was placed into Schedule V 

based both on abuse-related human and 

animal data submitted in its NDA and 

by epidemiological data which justified 

placement relative to drugs in Schedule 

IV. Given that ezogabine has abuserelated human and animal data in its 

NDA similar to the data generated by 

pregabalin, it is likely that ezogabine 

will have an abuse potential similar to 

this Schedule V drug. 

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

Public Health: The data indicates that 

ezogabine may present a serious safety 

risk to the public health, and the 

predicted level of risk is similar to that 

observed with pregabalin and 

lacosamide but less than that produced 

by Schedule IV benzodiazepines. In 

Phase 1 clinical safety studies, the 

overall adverse event profile following 

ezogabine administration was similar to 

those from pregabalin and lacosamide 

and includes not only euphoria, but also 

somnolence, and feeling or thinking 

abnormally. Further, the human abuse 

potential study showed that the majority 

of subjects receiving the 900 mg dose of 

ezogabine experienced multiple adverse 

events such as euphoria, somnolence, 

visual disturbance, amnesia, hypoaesthesia, paranoia, fear, confusion and 

hallucination. Although the 900 mg 

dose is three times greater than the 

recommended therapeutic dose, 

individuals who abuse drugs typically 

do so at supra-therapeutic doses. 

7. Its Psychic or Physiological 

Dependence Liability: Ezogabine may 

produce limited psychic or 

physiological dependence liability 

following extended administration. 

Since there are no studies detailing 

abrupt discontinuation of ezogabine, 

there are minimal adequate data to 

evaluate the ability of ezogabine to 

induce withdrawal symptoms that are 

indicative of physical dependence. 

Many of the adverse events reported 

from the discontinuation of ezogabine 

were also reported prior to its 

discontinuation, including dizziness, 


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somnolence, and a state of confusion. 

By comparison, abrupt or rapid 

discontinuation of pregabalin in human 

studies resulted in patient-reported 

symptoms of nausea, headache or 

diarrhea, which are suggestive of 

physical dependence, while abrupt 

termination of lacosamide produced no 

signs or symptoms of withdrawal in 

diabetic neuropathic pain patients. 

Unlike ezogabine and pregabalin, the 

withdrawal syndrome following 

discontinuation of Schedule IV 

substances such as alprazolam can range 

from mild dysphoria and insomnia to a 

major syndrome including abdominal 

pain, muscle cramps, vomiting, 

sweating, tremors and convulsions. 

These are similar in character to those 

associated with other sedativehypnotics. 

The study of ezogabine abuse 

potential in humans with histories of 

recreational abuse of sedative-hypnotics 

found that ezogabine produces euphoria 

(18–33%) in these individuals. 

Additionally, ezogabine produced 

euphoria (8.5%) in Phase 1 studies in 

healthy individuals. These euphoriarelated adverse events following 

administration of ezogabine are 

suggestive of its ability to produce 

psychic dependence, and the adverse 

events appear to be less severe and 

occur less frequently than Schedule IV 

drugs (diazepam and alprazolam) and 

are more similar to those of Schedule V 

drugs, pregabalin and lacosamide. 

8. Whether the Substance is an 

Immediate Precursor of a Substance 

Already Controlled Under the CSA: 

Ezogabine is not an immediate 

precursor of any controlled substance. 

Conclusion: Based on consideration of 

the scientific and medical evaluation 

and accompanying recommendation of 

HHS, and based on DEA’s consideration 

of its own eight-factor analysis, DEA 

finds that these facts and all relevant 

data constitute substantial evidence of 

potential for abuse of ezogabine. As 

such, DEA hereby proposes to schedule 

ezogabine 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 to place 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)(5), 

finds that: 

(1) Ezogabine has a low potential for 

abuse relative to the drugs or other 

substances in Schedule IV. The overall 

abuse potential of ezogabine is 

comparable to the Schedule V 

substances such as pregabalin and 

lacosamide; 

(2) Ezogabine has a currently accepted 

medical use in treatment in the United 

States. Ezogabine was approved for 

marketing by FDA as an adjunct 

treatment of partial onset seizures; and 

(3) Abuse of ezogabine may lead to 

limited physical dependence or 

psychological dependence relative to 

the drugs or other substances in 

Schedule IV. 

Based on these findings, the 

Administrator of DEA concludes that 

ezogabine, 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 V of the CSA (21 

U.S.C. 812(b)(5)). 

Requirements for Handling Ezogabine 

If this rule is finalized as proposed, 

ezogabine would be 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 

V controlled substance, including the 

following: 

Registration. Any person who 

manufactures, distributes, dispenses, 

imports, exports, engages in research or 

conducts instructional activities with 

ezogabine, or who desires to 

manufacture, distribute, dispense, 

import, export, engage in research or 

conduct instructional activities with 

ezogabine, 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. Ezogabine 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 ezogabine 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 ezogabine would be required 

to keep an inventory of all stocks of 

ezogabine 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 V for ezogabine 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, 1304.06, 1304.21, 

1304.22, and 1304.23. 

Prescriptions. Ezogabine or products 

containing ezogabine would be required 

to be distributed or dispensed pursuant 

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

21 CFR 1306.03–1306.06, 1306.08, 

1306.21, and 1306.23–1306.27. 

Importation and Exportation. All 

importation and exportation of 

ezogabine would need to be done in 

accordance with 21 CFR part 1312, 

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

958. 

Criminal Liability. Any activity with 

ezogabine not authorized by, or in 

violation of, Subchapter I Part D and 

Subchapter II of the CSA or the CSIEA 

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. 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 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. 


jlentini on DSK4TPTVN1PROD with PROPOSALS
65428 Federal Register / Vol. 76, No. 204 / Friday, October 21, 2011 / Proposed Rules 

Executive Order 13175 

This proposed rule will not have 

Tribal implications and will not impose 

substantial direct compliance costs on 

Indian Tribal governments. 

Paperwork Reduction Act of 1995 

This action does not impose a new 

collection of information 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 to 

read 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. Section 1308.15 is amended by 

redesignating paragraphs (e)(1) and (2) 

as paragraphs (e)(2) and (3), and adding 

a new paragraph (e)(1) to read as 

follows: 

§ 1308.15 Schedule V. 

* * * * * 

(e) * * * 

(1) Ezogabine—2779 

* * * * * 

Dated: October 14, 2011. 

Michele M. Leonhart, 

Administrator. 

[FR Doc. 2011–27253 Filed 10–20–11; 8:45 am] 

BILLING CODE 4410–09–P 

DEPARTMENT OF JUSTICE 

Bureau of Prisons 

28 CFR Part 524 

[BOP–1155–P] 

RIN 1120–AB55 

Classification and Program Review 

AGENCY: Bureau of Prisons, Department 

of Justice. 

ACTION: Notice of proposed rulemaking. 

SUMMARY: In this document, the Bureau 

of Prisons (Bureau) proposes to revise 

its regulations on classification and 

program review to ensure that 

classification and program review 

procedures adequately address inmate 

needs. This proposed rule also adds a 

new type of review, the ‘‘progress 

review.’’ A progress review will be an 

abbreviated program review meant to 

focus on an inmate’s programming 

activities. This shortened version of the 

more thorough program review will 

facilitate more efficiently-used staff and 

inmate time, in that it will primarily 

focus on any new or changed aspects of 

an inmate’s initial classification and 

participation in recommended 

programs. Inmates who have 36 months 

or more until their projected release 

date will receive alternating program 

and progress reviews at least once every 

180 calendar days, a practice that will 

allow the Bureau to more efficiently 

utilize staff time and resources. The 

process will also allow staff to devote 

more time and resources to the reviews 

of inmates who are closer to their 

release dates, enabling the Bureau to 

better fulfill its mission to prepare 

inmates for eventual release into 

communities within the United States. 

DATES: Comments due by December 20, 

2011. 

ADDRESSES: Comments should be 

submitted to the Rules Unit, Office of 

General Counsel, Bureau of Prisons, 320 

First Street, NW., Washington, DC 

20534. You may also comment via the 

Internet to BOP at 

BOPRULES@BOP.GOV or by using the 

http://www.regulations.gov comment 

form for this regulation. When 

submitting comments electronically you 

must include the BOP Docket No. in the 

subject box. 

FOR FURTHER INFORMATION CONTACT: 

Sarah Qureshi, Office of General 

Counsel, Bureau of Prisons, phone (202) 

307–2105. 

SUPPLEMENTARY INFORMATION: 

Posting of Public Comments 

Please note that all comments 

received are considered part of the 

public record and are made available for 

public inspection online 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 

posted online, you must include the 

phrase ‘‘PERSONAL IDENTIFYING 

INFORMATION’’ in the first paragraph 

of your comment. You must also locate 

all the personal identifying information 

you do not want posted online 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, 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 on http:// 

www.regulations.gov. 

Personal identifying information 

identified and located as set forth above 

will be placed in the agency’s public 

docket file, but not posted online. 

Confidential business information 

identified and located as set forth above 

will not be placed in the public docket 

file. If you wish to inspect the agency’s 

public docket file in person by 

appointment, please see the ‘‘For 

Further Information Contact’’ paragraph. 

Proposed Rule 

In this document, we propose to 

revise the regulations which set forth 

the classification and program review 

rules and to add a new level of review: 

progress reviews. 

Section 524.10 Purpose 

In this proposed section, we explain 

that the purpose of this subpart is to 

explain the Bureau’s process for 

classifying newly committed inmates, 

conducting program reviews, and 

conducting progress reviews. We have 

only revised the introductory paragraph 

of this section, to add the concept of 

progress reviews (which will be 

explained below). The three types of 

reviews listed here will be conducted 

for all inmates except: (1) Pretrial 

inmates, who are covered in 28 CFR part 

551; and (2) inmates committed for 

study and observation. 

Pretrial inmate reviews are not 

described in this subpart because they 

are specifically covered in 28 CFR 

551.107. According to that regulation, 

pretrial inmates are scheduled for an 

initial review by the unit team within 21 

calendar days of the inmate’s arrival at 

the institution, and later reviews are 

conducted at least once every 90 days. 

Inmates committed for study and 

observation do not receive the reviews 

described because they do not receive 

program or work assignments while in 

this status. Such inmates are typically 

committed to the Bureau to determine 

competency to stand trial or for other 

mental health or medical assessments, 

and are inappropriate for assignment to 

work or other Bureau programs. 


jlentini on DSK4TPTVN1PROD with PROPOSALS