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contains regulatory documents having general

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Rules and Regulations Federal Register

23789 

Vol. 74, No. 97 

Thursday, May 21, 2009 

DEPARTMENT OF JUSTICE 

Drug Enforcement Administration 

21 CFR Part 1308 

[Docket No. DEA–325F] 

Schedules of Controlled Substances: 

Placement of Lacosamide into 

Schedule V 

AGENCY: Drug Enforcement 

Administration (DEA), Department of 

Justice. 

ACTION: Final rule. 

SUMMARY: With the issuance of this final 

rule, the Deputy Administrator of the 

DEA places the substance lacosamide 

[(R)-2-acetoamido-N-benzyl-3-methoxypropionamide] and any material, 

compound, mixture, or preparation 

which contains any quantity of 

lacosamide into schedule V of the 

Controlled Substances Act (CSA). As a 

result of this rule, the regulatory 

controls and criminal sanctions of 

schedule V will be applicable to the 

manufacture, distribution, dispensing, 

importation and exportation of 

lacosamide. 

DATES: Effective Date: This rule is 

effective June 22, 2009. 

FOR FURTHER INFORMATION CONTACT: 

Christine A. Sannerud, PhD, Chief, Drug 

and Chemical Evaluation Section, Office 

of Diversion Control, Drug Enforcement 

Administration, 8701 Morrissette Drive, 

Springfield, VA 22152, (202) 307–7183. 

SUPPLEMENTARY INFORMATION: 

Background 

On October 28, 2008, the Food and 

Drug Administration (FDA) approved 

lacosamide [(R)-2-acetoamido-N-benzyl3-methoxy-propionamide] for marketing 

under the trade name Vimpat® for use 

as an adjunctive therapy in treatment of 

partial-onset seizures in patients with 

epilepsy ages 17 years and older. 

On December 2, 2008, the Assistant 

Secretary for Health of the Department 

of Health and Human Services (DHHS) 

sent the Administrator of the DEA a 

scientific and medical evaluation and a 

letter recommending that lacosamide be 

placed into schedule V of the CSA. 

Enclosed with the December 2, 2008, 

letter was a document prepared by the 

FDA entitled ‘‘Basis for the 

Recommendation for Control of 

Lacosamide in Schedule V of the 

Controlled Substances Act (CSA).’’ The 

document contained a review of the 

factors which the CSA requires the 

Secretary to consider (21 U.S.C. 811(b)). 

Based on the recommendation of the 

Assistant Secretary for Health and an 

independent review of the available 

data by the DEA, the Deputy 

Administrator of the DEA, in a March 

10, 2009, Notice of Proposed 

Rulemaking (74 FR 10205) proposed 

placement of lacosamide into schedule 

V of the CSA. The proposed rule 

provided an opportunity for all 

interested persons to submit their 

comments, objections, or requests for 

hearing to be received by the DEA on or 

before April 9, 2009. 

Comments Received 

DEA received one comment within 

the comment period in response to the 

Notice of Proposed Rulemaking. The 

commenter stated that lack of 

information and inappropriate 

comparisons to other drugs precluded 

the scheduling of lacosamide and 

suggested that scheduling be postponed 

for 24 months to collect data. 

DEA does not agree. The studies used 

to assess abuse potential of lacosamide 

are widely held as the standard methods 

of evaluation. Behavioral effects of 

lacosamide in animals and humans 

were found to be similar to, but 

transient relative to, those of the 

schedule IV drugs alprazolam and 

phenobarbital. Preclinical studies 

indicated that lacosamide is selfadministered at rates higher than saline 

and partially mimics discrimitive 

stimulus effects to the schedule IV 

substances alprazolam and 

phenobarbital. In clinical trials, 

lacosamide produced subjective 

responses similar to alprazolam but 

these effects did not last as long as 

alprazolam. After careful consideration 

of positive indicators from preclinical 

and clinical studies, DEA finds 

lacosamide has abuse potential 

supporting placement in schedule V 

under the CSA. The DHHS 

recommended control in schedule V of 

the CSA and the DEA concurs. 

The commenter also submitted a 

request for a hearing. DEA regulations 

provide that ‘‘[a]ny interested person’’ 

may request a hearing on a proposed 

scheduling action. 21 CFR 1308.44(a). 

DEA regulations define ‘‘interested 

person’’ as ‘‘any person adversely 

affected or aggrieved by any rule or 

proposed rule issuable pursuant to [21 

U.S.C. 811].’’ 21 CFR 1300.01(b)(19). 

The regulations further require that any 

person requesting a hearing must state 

‘‘with particularity’’ his interest in the 

proceeding. 21 CFR 1316.47(a). The 

commenter failed to provide sufficient 

information to demonstrate that he 

meets the definition of ‘‘interested 

person’’ as set forth in the regulations, 

therefore DEA is denying his hearing 

request. 

DEA also received many comments 

after the comment period closed. These 

late comments were not considered by 

DEA. 

Scheduling of Lacosamide 

Based on the scientific and medical 

evaluation and the recommendation of 

the Assistant Secretary for Health, 

received in accordance with section 

201(b) of the Act (21 U.S.C. 811(b)), and 

the independent review of the available 

data by the DEA, the Deputy 

Administrator of the DEA, pursuant to 

sections 201(a) and 201(b) of the Act (21 

U.S.C. 811(a) and 811(b)), finds that: 

(1) Lacosamide has a low potential for 

abuse relative to the drugs or other 

substances in schedule IV; 

(2) Lacosamide has a currently 

accepted medical use in treatment in the 

United States; and 

(3) Abuse of lacosamide may lead to 

limited physical dependence or 

psychological dependence relative to 

the drugs or other substances in 

schedule IV. 

Based on these findings, the Deputy 

Administrator of the DEA concludes 

that lacosamide and any material, 

compound, mixture, or preparation 

which contains any quantity of 

lacosamide, warrant control in schedule 

V of the CSA. 

Requirements for Handling Lacosamide 

Registration. Any person who 

manufactures, distributes, dispenses, 


dwashington3 on PROD1PC60 with RULES
23790 Federal Register / Vol. 74, No. 97 / Thursday, May 21, 2009 / Rules and Regulations 

imports, exports, engages in research or 

conducts instructional activities with 

lacosamide, or who desires to 

manufacture, distribute, dispense, 

import, export, engage in instructional 

activities or conduct research with 

lacosamide, must be registered to 

conduct such activities in accordance 

with Part 1301 of Title 21 of the Code 

of Federal Regulations (CFR). Any 

person who is currently engaged in any 

of the above activities and is not 

registered with DEA must submit an 

application for registration on or before 

June 22, 2009 and may continue their 

activities until the DEA has approved or 

denied the application. 

Security. Lacosamide is subject to 

schedule III–V security requirements 

and must be manufactured, distributed, 

and stored in accordance with 

§§ 1301.71, 1301.72(b), (c), and (d), 

1301.73, 1301.74, 1301.75(b) and (c), 

1301.76, and 1301.77 of Title 21 of the 

CFR on and after June 22, 2009. 

Labeling and Packaging. All labels 

and labeling for commercial containers 

of lacosamide which are distributed on 

or after June 22, 2009 must comply with 

requirements of §§ 1302.03–1302.07 of 

Title 21 of the Code of Federal 

Regulations. 

Inventory. Every registrant required to 

keep records and who possesses any 

quantity of lacosamide must keep an 

inventory of all stocks of lacosamide on 

hand pursuant to §§ 1304.03, 1304.04 

and 1304.11 of Title 21 of the CFR on 

or after June 22, 2009. Every registrant 

who desires registration in schedule V 

for lacosamide must conduct an 

inventory of all stocks of the substance 

on hand at the time of registration. 

Records. All registrants must keep 

records pursuant to §§ 1304.03, 1304.04, 

1304.21, 1304.22, and 1304.23 of Title 

21 of the Code of Federal Regulations on 

or after June 22, 2009. 

Prescriptions. All prescriptions for 

lacosamide pharmaceutical products 

must be issued pursuant to 21 CFR 

1306.03–1306.06 and 1306.21, 1306.23– 

1306.27 on or after June 22, 2009. 

Importation and Exportation. All 

importation and exportation of 

lacosamide must be in compliance with 

part 1312 of Title 21 of the CFR on or 

after June 22, 2009. 

Criminal Liability. Any activity with 

lacosamide not authorized by, or in 

violation of, the CSA or the Controlled 

Substances Import and Export Act 

occurring on or after June 22, 2009 shall 

be unlawful. 

Regulatory Certifications 

Executive Order 12866 

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 5 U.S.C. 556 and 557 

and, as such, are exempt from review by 

the Office of Management and Budget 

pursuant to Executive Order 12866, 

§ 3(d)(1). 

Regulatory Flexibility Act 

The Deputy Administrator, in 

accordance with the Regulatory 

Flexibility Act (5 U.S.C. 601–612), has 

reviewed this final rule and by 

approving it certifies that it will not 

have a significant economic impact on 

a substantial number of small entities. 

Lacosamide pharmaceutical products 

will be prescription drugs used for the 

treatment of partial-onset seizures. 

Handlers of lacosamide often handle 

other controlled substances used in the 

treatment of central nervous system 

disorders which are already subject to 

the regulatory requirements of the CSA. 

Executive Order 12988 

This regulation meets the applicable 

standards set forth in §§ 3(a) and 3(b)(2) 

of Executive Order 12988, Civil Justice 

Reform. 

Executive Order 13132 

This 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. 

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 $120,000,000 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. 

Congressional Review Act 

This rule is not a major rule as 

defined by § 804 of the Small Business 

Regulatory Enforcement Fairness Act of 

1996 (Congressional Review Act). This 

rule will not result in an annual effect 

on the economy of $100,000,000 or 

more; a major increase in costs or prices: 

or significant adverse effects on 

competition, employment, investment, 

productivity, innovation, or on the 

ability of United States-based 

companies to compete with foreign 

based companies in domestic and 

export markets. 

List of Subjects in 21 CFR Part 1308 

Administrative practice and 

procedure, Drug traffic control, 

Narcotics, Prescription drugs. 

■ Under the authority vested in the 

Attorney General by section 201(a) of 

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

delegated to the Administrator of DEA 

by Department of Justice regulations (28 

CFR 0.100), and redelegated to the 

Deputy Administrator pursuant to Title 

28, Part 0, Appendix to Subpart R, 

Section 12, the Deputy Administrator 

hereby amends 21 CFR part 1308 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 

revising paragraph (e)(1) and adding a 

new paragraph (e)(2) to read as follows: 

§ 1308.15 Schedule V. 

* * * * * 

(e) * * * 

(1) Lacosamide [(R)-2-acetoamido-Nbenzyl-3-methoxy-propionamide]—2746 

(2) Pregabalin [(S)-3-(aminomethyl)-5- 

methylhexanoic acid]—2782 

Dated: May 12, 2009. 

Michele M. Leonhart, 

Deputy Administrator. 

[FR Doc. E9–11927 Filed 5–20–09; 8:45 am] 

BILLING CODE 4410–09–P 

DEPARTMENT OF JUSTICE 

Drug Enforcement Administration 

21 CFR Part 1308 

[Docket No. DEA–319F] 

Schedules of Controlled Substances: 

Placement of Tapentadol Into Schedule 

II 

AGENCY: Drug Enforcement 

Administration, Department of Justice. 

ACTION: Final rule. 

SUMMARY: With the issuance of this final 

rule, the Deputy Administrator of the 

Drug Enforcement Administration 

(DEA) places the substance tapentadol, 

including its isomers, esters, ethers, 

salts and salts of isomers, esters and 

ethers whenever the existence of such 

isomers, esters, ethers, and salts is 

possible, into schedule II of the 


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