[Federal Register Volume 59, Number 44 (Monday, March 7, 1994)]
[Unknown Section]
[Page 0]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 94-5202]
[[Page Unknown]]
[Federal Register: March 7, 1994]
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Part III
Department of Justice
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Drug Enforcement Administration
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21 CFR Part 1308
Schedules of Controlled Substances; Extension of Temporary Placement of
Alpha-ethyltryptamine Into Schedule I; Proposed Rule and Final Rule
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DEPARTMENT OF JUSTICE
Drug Enforcement Administration
21 CFR Part 1308
Schedules of Controlled Substances; Proposed Placement of Alpha-
ethyltryptamine Into Schedule I
AGENCY: Drug Enforcement Administration, Justice.
ACTION: Notice of proposed rulemaking.
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SUMMARY: This notice of proposed rulemaking is issued by the Acting
Administrator of the Drug Enforcement Administration (DEA) to place
alpha-ethyltryptamine (-ET) into Schedule I of the Controlled
Substances Act (CSA). This proposed action by the DEA Acting
Administrator is based on data gathered and reviewed by the DEA. If
finalized, this proposed action would impose the regulatory control
mechanisms and criminal sanctions of Schedule I on the manufacture,
distribution, and possession of -ET.
DATES: Comments must be submitted on or before April 6, 1994.
ADDRESSES: Comments and objections should be submitted to the
Administrator, Drug Enforcement Administration, Washington, DC 20537,
Attention: DEA Federal Register Representative.
FOR FURTHER INFORMATION CONTACT: Howard McClain, Jr., Chief, Drug and
Chemical Evaluation Section, Drug Enforcement Administration,
Washington, DC 20537, Telephone: (202) 307-7183.
SUPPLEMENTARY INFORMATION: On March 12, 1993, the Administrator of the
DEA published a final rule in the Federal Register (58 FR 13533)
amending Sec. 1308.11 of title 21 of the Code of Federal Regulations to
temporarily place -ET into Schedule I of the CSA pursuant to
the temporary scheduling provisions of 21 U.S.C. 811(h). This final
rule, which became effective on the date of publication, was based on
findings by the Administrator that the temporary scheduling of
-ET was necessary to avoid an imminent hazard to the public
safety. Section 201(h)(2) of the CSA (21 U.S.C. 811(h)(2)) requires
that the temporary scheduling of a substance expires at the end of one
year from the effective date of the order. However, if proceedings to
schedule a substance pursuant to 21 U.S.C. 811(a)(1) have been
initiated and are pending, the temporary scheduling of a substance may
be extended for up to six months. Under this provision, the temporary
scheduling of -ET which would expire on March 12, 1994, may be
extended to September 12, 1994. This extension is being ordered by the
DEA Acting Administrator in a separate action.
The DEA has gathered and reviewed the available information
regarding the trafficking, actual abuse and the relative potential for
abuse for -ET. The Acting Administrator has submitted this
data to the Assistant Secretary for Health, Department of Health and
Human Services. In accordance with 21 U.S.C. 811(b), the Acting
Administrator also requested a scientific and medical evaluation and a
scheduling recommendation for -ET from the Assistant Secretary
for Health.
Chemically -ET is -ethyl-1H-indole-3-ethanamine
or 3-(2-aminobutyl) indole. It is also known as etryptamine or Monase
(brand name, acetate salt). In the early 1960's, it was marketed by the
Upjohn Company as an antidepressant in the United States. After less
than one year of marketing, Upjohn withdrew its New Drug Application
when it became apparent that -ET administration was associated
with agranulocytosis. The Food and Drug Administration (FDS) has
notified the DEA that there are no exemptions or approvals in effect
under section 505 of the Federal Food, Drug, and Cosmetic Act for
-ET. A search of the scientific and medical literature
revealed no indications of current medical use of -ET in the
United States.
In animal studies, -ET has a pharmacological profile
similar to other Schedule I controlled substances. In drug
discrimination paradigms, -ET fully substituted for both 1-
(2,5-dimethoxy-4-methylphenyl)-2-aminopropane (DOM) and 3,4-
methylenedioxymethamphetamine (MDMA). In a behavioral paradigm that
distinguishes between stimulants, classical hallucinogens and MDMA-like
substances, -ET closely resembles MDMA. Recent data indicate
that -ET, like MDMA, may be toxic to serotonergic neurons. In
human studies, -ET's most prominent effect was an immediate
feeling of exhilaration and intoxication at an oral dose of 150 mg.
DEA first encountered -ET in 1986 at a clandestine
laboratory in Nevada. Several exhibits of -ET have been
analyzed by DEA and state forensic laboratories since 1989.
Individuals in Colorado and Arizona have purchased several
kilograms of this substance from chemical supply companies. It has been
distributed and sold primarily to high school and college students.
Trafficked as ``ET'' or ``TRIP'', it has been touted as an MDMA-like
substance. The death of a nineteen year old female in Arizona was
attributed to -ET toxicity. Illicit use has been documented in
both Germany and Spain. In Germany, -ET has been sold as
``Love Pearls'' or ``Love Pills'' and its abuse has been associated
with a number of deaths. At least one death has been attributed to
-ET abuse in Spain.
The Acting Administrator, based on the information gathered and
reviewed by his staff and after consideration of the factors in 21
U.S.C. 811(c), believes that sufficient data exist to propose and to
support that -ET be placed into Schedule I of the CSA pursuant
to 21 U.S.C. 811(a). The specific findings required pursuant to 21
U.S.C. 811 and 812 for a substance to be placed into Schedule I are as
follows:
(1) The drug or other substance has a high potential for abuse.
(2) The drug or other substance has no currently accepted medical
use in treatment in the United States.
(3) There is a lack of accepted safety for use of the drug or other
substance under medical supervision.
Before issuing a final rule in this matter, the DEA Administrator
will take into consideration the scientific and medical evaluation and
scheduling recommendation of the Secretary of the Department of Health
and Human Services in accordance with 21 U.S.C. 811(b). The
Administrator will also consider relevant comments from other concerned
parties.
Interested persons are invited to submit their comments,
objections, or requests for a hearing in writing 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
Administrator, Drug Enforcement Administration, Washington, DC 20537,
Attention: DEA Federal Register Representative. In the event that
comments, objections, or requests for a hearing raise one or more
issues which the Administrator finds warrants a hearing, the
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.
The Acting Administrator of the DEA hereby certifies that proposed
placement of -ET into Schedule I of the CSA will have no
significant impact upon entities whose interests must be considered
under the Regulatory Flexibility Act, 5 U.S.C. 601 et seq. This action
involves the control of a substance with no currently accepted medical
use in the United States.
This proposed rulemaking is not a significant regulatory action for
the purposes of Executive Order (E.O.) 12866 of September 30, 1993.
Drug scheduling matters are not subject to review by the Office of
Management and Budget (OMB) pursuant to provisions of E.O. 12866,
Sec. 3(d)(1).
This action has been analyzed in accordance with the principles and
criteria in E.O. 12612, and it has been determined that this proposed
rulemaking does not have sufficient federalism implications to warrant
the preparation of a Federalism Assessment.
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 the DEA by the Department of Justice regulations (28
CFR 0.100), the Acting Administrator hereby proposes that 21 CFR part
1308 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, 871b, unless otherwise noted.
2. Section 1308.11 is amended by redesignating the existing
paragraphs (d)(12) through (d)(29) as (d)(13) through (d)(30) and
adding a new paragraph (d)(12) to read as follows:
Sec. 1308.11 Schedule I.
* * * * *
(d) * * *
(12) Alpha-ethyltryptamine
7249
Some trade or other names: etryptamine; Monase; -ethyl-1H-
indole-3-ethanamine; 3-(2-aminobutyl)indole; -ET or AET
3. Section 1308.11 is further amended by removing paragraph (g)(4)
and redesignating paragraph (g)(5) as (g)(4).
Dated: February 28, 1994.
Stephen H. Greene,
Acting Administrator of Drug Enforcement.
[FR Doc. 94-5202 Filed 3-4-94; 8:45 am]
BILLING CODE 4410-09-M