[Federal Register: July 29, 2005 (Volume 70, Number 145)]
[Proposed Rules]
[Page 43809-43811]
From the Federal Register Online via GPO Access [wais.access.gpo.gov]
[DOCID:fr29jy05-30]
=======================================================================
-----------------------------------------------------------------------
DEPARTMENT OF JUSTICE
Drug Enforcement Administration
21 CFR Part 1308
[Docket No. DEA-269P]
Schedules of Controlled Substances: Placement of Embutramide Into
Schedule III
AGENCY: Drug Enforcement Administration, Department of Justice.
ACTION: Notice of proposed rulemaking.
-----------------------------------------------------------------------
SUMMARY: This proposed rule is issued by the Deputy Administrator of
the Drug Enforcement Administration (DEA) to place the substance
embutramide, including its salts, into Schedule III of the Controlled
Substances Act (CSA). This proposed action is based on a recommendation
from the Acting Assistant Secretary for Health of the Department of
Health and Human Services (DHHS) and on an evaluation of the relevant
data by DEA. If finalized, this action will impose the regulatory
controls and criminal sanctions applicable to Schedule III on those who
handle embutramide and products containing embutramide.
DATES: Written comments must be postmarked, and electronic comments
must be sent, on or before August 29, 2005.
ADDRESSES: To ensure proper handling of comments, please reference
``Docket No. DEA-269P'' on all written and electronic correspondence.
Written comments being sent via regular mail should be sent to the
Deputy Administrator, Drug Enforcement Administration, Washington, DC
20537, Attention: DEA Federal Register Representative/ODL. Written
comments sent via express mail should be sent to the Deputy
Administrator, Drug Enforcement Administration, Attention: DEA Federal
Register Representative/ODL, 2401 Jefferson-Davis Highway, Alexandria,
VA 22301. Comments may be directly sent to DEA electronically by
sending an electronic message to dea.diversion.policy@usdoj.gov.
Comments may also be sent electronically through http://www.regulations.gov
using the electronic comment form provided on that
site. An electronic copy of this document is also available at the
http://www.regulations.gov Web site. DEA will accept electronic
comments containing MS Word, WordPerfect, Adobe PDF, or Excel file
formats only. DEA will not accept any file format other than those
specifically listed here.
[[Page 43810]]
FOR FURTHER INFORMATION CONTACT: Christine Sannerud, Ph.D., Chief, Drug
and Chemical Evaluation Section, Drug Enforcement Administration,
Washington, DC 20537, (202) 307-7183.
SUPPLEMENTARY INFORMATION:
Note Regarding This Scheduling Action
In accordance with the provisions of the Controlled Substances Act
(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). Interested persons are invited to submit their
comments, objections or requests for a hearing with regard to this
proposal. Requests for a hearing should be filed in accordance with 21
CFR 1308.44 and should state, with particularity, the issues concerning
which the person desires to be heard. All correspondence regarding this
matter should be submitted to the Drug Enforcement Administration using
the address information provided above.
Background
Embutramide is a central nervous system depressant drug. On May 20,
2005, the Food and Drug Administration (FDA) approved a New Animal Drug
Application (NADA) that provides for veterinary prescription use of
TributameTM Euthanasia Solution containing embutramide,
chloroquine phosphate, and lidocaine by intravenous injection for
euthanasia of dogs (70 FR 36336). Embutramide as one of the ingredients
in the veterinary euthanasia drug product, T-61, was previously
marketed in the United States. T-61 was withdrawn from the market in
1991.
Embutramide is a derivative of gamma-hydroxybutyric acid (GHB). Its
chemical name is N-[2-(m-methoxyphenyl)-2-ethyl-butyl]-gamma-
hydroxybutyramide (CAS number 15687-14-6). Embutramide shares
pharmacological similarities with other central nervous system (CNS)
depressants such as barbiturates, GHB and ketamine. It produces a
reversible stupor-like state (narcosis) in experimental animals.
The effects of embutramide on locomotor activity, rearing, forelimb
grip strength, hind-limb splay, and the performance of inverted screen
tests on rodents were similar to those of pentobarbital. Embutramide
produces complete substitution for the pentobarbital discriminative
stimulus in mice. Methohexital-trained rhesus monkeys self-administer
embutramide.
The pharmacological data suggest that the abuse potential of
embutramide may be similar to that of CNS depressants such as
barbiturates and their products (Schedules II through IV) and GHB and
its product (Schedules I and III) that are controlled under the CSA.
Case reports of suicides, attempted suicides, and accidental exposures
involving embutramide containing products have been published in the
scientific literature. Embutramide is not currently marketed in the
United States. From 1998 to 2004, there were no law enforcement
encounters of embutramide including seizures or cases.
On January 26, 2005, the Acting Assistant Secretary for Health,
DHHS, sent the Deputy Administrator of DEA a scientific and medical
evaluation and a letter recommending that embutramide be placed into
Schedule III of the CSA. Enclosed with the January 26, 2005, letter was
a document prepared by the FDA entitled, ``Basis for the Recommendation
to Control Embutramide in Schedule III 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)).
The factors considered by the Acting Assistant Secretary of Health
and DEA with respect to embutramide were:
(1) Its actual or relative potential for abuse;
(2) Scientific evidence of its pharmacological effects;
(3) The state of current scientific knowledge regarding the drug;
(4) Its history and current pattern of abuse;
(5) The scope, duration, and significance of abuse;
(6) What, if any, risk there is to the public health;
(7) Its psychic or physiological dependence liability; and
(8) Whether the substance is an immediate precursor of a substance
already controlled under this subchapter. (21 U.S.C. 811(c))
Based on the recommendation of the Acting 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
DEA, the Deputy Administrator of DEA, pursuant to sections 201(a) and
201(b) of the Act (21 U.S.C. 811(a) and 811(b)), finds that:
(1) Based on information now available, embutramide has a low
potential for abuse relative to the drugs or other substances in
Schedules I and II;
(2) Embutramide has a currently accepted medical use in treatment
in the United States; and
(3) Abuse of embutramide may lead to moderate or low physical
dependence or high psychological dependence.
Based on these findings, the Deputy Administrator of DEA concludes
that embutramide warrants control in Schedule III of the CSA.
Interested persons are invited to submit their comments, objections
or requests for a hearing with regard to this proposal. Requests for a
hearing should state, with particularity, the issues concerning which
the person desires to be heard. All correspondence regarding this
matter should be submitted to the Deputy Administrator, Drug
Enforcement Administration, Washington, DC 20537, Attention: DEA
Federal Register Representative/ODL. In the event that comments,
objections, or requests for a hearing raise one or more issues which
the Deputy Administrator finds warrant a hearing, the Deputy
Administrator shall order a public hearing by notice in the Federal
Register, summarizing the issues to be heard and setting the time for
the hearing.
Requirements for Handling Embutramide
If this rule is finalized as proposed, embutramide would be subject
to Controlled Substances Act and Controlled Substances Import and
Export Act regulatory controls and administrative, civil and criminal
sanctions applicable to the manufacture, distribution, dispensing,
importing and exporting of a Schedule III controlled substance,
including the following:
Registration. Any person who manufactures, distributes, dispenses,
imports, exports, engages in research or conducts instructional
activities with embutramide, or who desires to manufacture, distribute,
dispense, import, export, engage in instructional activities or conduct
research with embutramide, would need to be registered to conduct such
activities in accordance with Part 1301 of Title 21 of the Code of
Federal Regulations.
Security. Embutramide would be 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
Code of Federal Regulations.
Labeling and Packaging. All labels and labeling for commercial
containers of embutramide which are distributed after finalization of
this rule would need to comply with requirements of Sec. Sec. 1302.03-
1302.07 of Title 21 of the Code of Federal Regulations.
[[Page 43811]]
Inventory. Every registrant required to keep records and who
possesses any quantity of embutramide would be required to keep an
inventory of all stocks of embutramide on hand pursuant to Sec. Sec.
1304.03, 1304.04 and 1304.11 of Title 21 of the Code of Federal
Regulations. Every registrant who desires registration in Schedule III
for embutramide 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 Sec. Sec. 1304.03, 1304.04, 1304.21, 1304.22, and 1304.23 of Title
21 of the Code of Federal Regulations.
Prescriptions. All prescriptions for embutramide or prescriptions
for products containing embutramide would be required to be issued
pursuant to 21 CFR 1306.03-1306.06 and 1306.21-1306.27. All
prescriptions for embutramide or products containing embutramide issued
after publication of the Final Rule, if authorized for refilling, would
be limited to five refills.
Importation and Exportation. All importation and exportation of
embutramide would need to be in compliance with part 1312 of Title 21
of the Code of Federal Regulations.
Criminal Liability. Any activity with embutramide not authorized
by, or in violation of, the Controlled Substances Act or the Controlled
Substances Import and Export Act occurring on or after finalization of
this proposed rule would 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, section 3(d)(1).
Regulatory Flexibility Act
The Deputy Administrator, in accordance with the Regulatory
Flexibility Act (5 U.S.C. 605(b)), 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. Embutramide products
will be prescription drugs used for the euthanasia of animals. Handlers
of embutramide also handle other controlled substances used to
euthanize animals which are already subject to the regulatory
requirements of the CSA.
Executive Order 12988
This regulation meets the applicable standards set forth in
Sections 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
$115,000,000 or more 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.
Small Business Regulatory Enforcement Fairness Act of 1996
This rule is not a major rule as defined by section 804 of the
Small Business Regulatory Enforcement Fairness Act of 1996. 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 28 CFR
0.104, the Deputy Administrator hereby proposes that 21 CFR part 1308
be amended as follows:
PART 1308--SCHEDULES OF CONTROLLED SUBSTANCES [AMENDED]
1. The authority citation for Part 1308 continues to read as
follows:
Authority: 21 U.S.C. 811, 812, 871(b), unless otherwise noted.
2. Section 1308.13 is proposed to be amended by redesignating
paragraphs (c)(5) through (c)(13) as paragraphs (c)(6) through (c)(14),
and adding a new paragraph (c)(5) to read as follows:
Sec. 1308.13 Schedule III.
* * * * *
(c) * * *
(5) Embutramide.............................. XXXX
* * * * *
Dated: July 22, 2005.
Michele M. Leonhart,
Deputy Administrator.
[FR Doc. 05-15035 Filed 7-28-05; 8:45 am]
BILLING CODE 4410-09-P