[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