Date="03/07/94" Citation="59 FR 10718" Group="legal" Type="PROPOSED RULE" Department="DEPARTMENT OF JUSTICE" Agency="DRUG ENFORCEMENT ADMINISTRATION, JUSTICE" Subject="Schedules of Controlled Substances; Proposed Placement of Alpha-ethylt ryptamine Into Schedule I"

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.

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. + ------------------------------------------------------------ SUMMARY: This notice of proposed rulemaking is issued by the Acting Administrator of the Drug Enforcement Administration (DEA) to place alpha-ethyltryptamine (ALPHA-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 ALPHA-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 ALPHA-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 ALPHA-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 ALPHA-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 ALPHA-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 ALPHA-ET from the Assistant Secretary for Health. Chemically ALPHA-ET is ALPHA-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 ALPHA-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 ALPHA-ET. A search of the scientific and medical literature revealed no indications of current medical use of ALPHA-ET in the United States. In animal studies, ALPHA-ET has a pharmacological profile similar to other Schedule I controlled substances. In drug discrimination paradigms, ALPHA-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, ALPHA-ET closely resembles MDMA. Recent data indicate that ALPHA-ET, like MDMA, may be toxic to serotonergic neurons. In human studies, ALPHA-ET's most prominent effect was an immediate feeling of exhilaration and intoxication at an oral dose of 150 mg. DEA first encountered ALPHA-ET in 1986 at a clandestine laboratory in Nevada. Several exhibits of ALPHA-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 ALPHA-ET toxicity. Illicit use has been documented in both Germany and Spain. In Germany, ALPHA-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 ALPHA-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 ALPHA-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 ALPHA-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; ALPHA-ethyl-1H-indole- 3-ethanamine; 3-(2-aminobutyl)indole; ALPHA-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 ------------------------------------------------------ The Contents entry for this article reads as follows: Schedules of controlled substances: Alpha-ethyltryptamine, 10718