[Federal Register Volume 74, Number 97 (Thursday, May 21, 2009)]
[Rules and Regulations]
[Pages 23789-23790]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: E9-11927]



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Rules and Regulations
                                                Federal Register
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Federal Register / Vol. 74, No. 97 / Thursday, May 21, 2009 / Rules 
and Regulations

[[Page 23789]]



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.

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SUMMARY: With the issuance of this final rule, the Deputy Administrator 
of the DEA places the substance lacosamide [(R)-2-acetoamido-N-benzyl-
3-methoxy-propionamide] 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-benzyl-3-methoxy-propionamide] 
for marketing under the trade name Vimpat[supreg] 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 self-administered 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,

[[Page 23790]]

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 Sec. Sec.  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 Sec. Sec.  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 Sec. Sec.  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 Sec. Sec.  
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, Sec.  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 
Sec. Sec.  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 Sec.  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.

0
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

0
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.


0
2. Section 1308.15 is amended by revising paragraph (e)(1) and adding a 
new paragraph (e)(2) to read as follows:


Sec.  1308.15  Schedule V.

* * * * *
    (e) * * *
    (1) Lacosamide [(R)-2-acetoamido-N-benzyl-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