Date="01/14/93" Citation="58 FR 4370" Group="legal" Type="PROPOSED RULE" Department="DEPARTMENT OF JUSTICE" Agency="DRUG ENFORCEMENT ADMINISTRATION, JUSTICE" Subject="Schedules of Controlled Substances Temporary Placement of Alpha-ethylt ryptamine Into Schedule I"

DEPARTMENT OF JUSTICE Drug Enforcement Administration 21 CFR Part 1308 Schedules of Controlled Substances Temporary Placement of Alpha- ethyltryptamine Into Schedule I AGENCY: Drug Enforcement Administration, Justice. ACTION: Notice of intent.

DEPARTMENT OF JUSTICE Drug Enforcement Administration 21 CFR Part 1308 Schedules of Controlled Substances Temporary Placement of Alpha- ethyltryptamine Into Schedule I AGENCY: Drug Enforcement Administration, Justice. ACTION: Notice of intent. ------------------------------------------------------------ SUMMARY: The Administrator of the Drug Enforcement Administration (DEA) is issuing this notice of intent to temporarily place alpha-ethyltryptamine into Schedule I of the Controlled Substances Act (CSA) pursuant to the temporary scheduling provisions of the CSA (21 U.S.C. 811(h)). This intended action is based on the finding by the DEA Administrator that the placement of alpha- ethyltryptamine in Schedule I of the CSA is necessary to avoid an imminent hazard to the public safety. Finalization of this action will impose the criminal sanctions and regulatory controls of Schedule I on the manufacture, distribution, and possession of alpha-ethyltryptamine. 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: The Comprehensive Crime Control Act of 1984 (Pub. L. 98-473), which was signed into law on October 12, 1984, amended section 201 of the Controlled Substances Act (CSA) (21 U.S.C. 811) to give the Attorney General the authority to temporarily place a substance into Schedule I of the CSA if he finds that such action is necessary to avoid an imminent hazard to the public safety. A substance may be temporarily scheduled under the emergency provision of the CSA if that substance is not listed in any other schedule under section 202 of the CSA (21 U.S.C. 812) or if there is no approval or exemption in effect under 21 U.S.C. 355 for the substance. The Attorney General has delegated his authority under 21 U.S.C. 811 to the Administrator of DEA (28 CFR 0.100). In making a finding that placing a substance temporarily in Schedule I of the CSA is necessary to avoid an imminent hazard to the public safety the Administrator is required to consider three of the eight factors set forth in section 201(c) of the CSA (21 U.S.C. 811(c)). These factors are as follows: (4) History and current pattern of abuse; (5) The scope, duration and significance of abuse; and (6) What, if any, risk there is to the public health. Alpha-ethyltryptamine has been classified as a central nervous system (CNS) stimulant as well as a tryptamine hallucinogen. Chemically it is ALPHA-ethyl-1H-indole-3-ethanamine or 3-(2-aminobutyl)indole. It is structurally similar to N,N-dimethyltryptamine (DMT) and N,N-diethyltryptamine (DET) both of which are hallucinogens controlled in Schedule I of the CSA. Available data indicates that alpha-ethyltryptamine produces some pharmacological effects qualitatively similar to those of other Schedule I hallucinogens. DEA first encountered alpha-ethyltryptamine in 1986 at a clandestine laboratory in Nevada. Several exhibits of alpha- ethyltryptamine have been analyzed by DEA and state forensic laboratories since 1989. Individuals in Colorado and Arizona have purchased several kilograms of this substance as the acetate salt from chemical supply companies and have distributed and sold quantities to individuals for the purpose of human consumption. Touted as an MDMA (3, 4-methylenedioxymethamphetamine)-like substance, it has been trafficked as "TRIP" or "ET". Distribution and use has been primarily among high school and college-aged individuals. In Arizona, the death of a 19 year old female was attributed to acute alpha-ethyltryptamine toxicity. Illicit use has been documented in both Germany and Spain where two deaths have resulted from alpha-ethyltryptamine overdose. Alpha-ethyltryptamine acetate was marketed by the Upjohn Company in 1961 as an antidepressant under the trade name of Monase. After less than one year of marketing, Upjohn withdrew its New Drug Application when it became apparent that Monase administration was associated with the development of agranulocytosis. Recent scientific data would also suggest that this substance may produce neurotoxicity similar to the neuro-toxic effects produced by MDMA and PCA (para-chloroamphetamine). The continued uncontrolled availability of alpha-ethyltryptamine, its CNS stimulatory and hallucinogenic properties similar to those of DMT, DET and MDMA, its association with agranulocytosis and possible neurotoxicity, pose an imminent hazard to public safety. DEA is not aware of any therapeutic use of this substance in the United States. In accordance with the provisions of section 201(h) of the CSA (21 U.S.C. 811(h)) and 28 CFR 0.100 the Administrator has considered the three factors required for a determination of whether temporarily scheduling alpha-ethyltryptamine under the CSA is necessary to avoid an imminent hazard to the public safety. Based on a consideration of these factors and other relevant information, the Administrator finds that placement of alpha- ethyltryptamine into Schedule I of the CSA is necessary to avoid an imminent hazard to the public safety. As required by section 201(h)(4) of the CSA (21 U.S.C. 811(h)(4)), the Administrator has notified the Assistant Secretary for Health, delegate of the Secretary of Health and Human Services, of his intention to temporarily place alpha-ethyltryptamine into Schedule I of the CSA. Comments submitted by the Assistant Secretary for Health in response to this notification including whether there is an exemption or approval in effect for alpha-ethyltryptamine under the Federal Food, Drug and Cosmetic Act, shall be taken into consideration before a final order is published. Because the Administrator finds that it is necessary to temporarily place alpha-ethyltryptamine into Schedule I to avoid an imminent hazard to the public safety, the final order, if issued, will be effective on the date of publication of the Federal Register. Further, it is the intention of the Administrator to issue such a final order as soon as possible after the expiration of thirty days from the date of publication of this notice and the date that notification was transmitted to the Assistant Secretary for Health. The Administrator of the Drug Enforcement Administration hereby certifies that this notice of intent to temporarily place alpha-ethyltryptamine 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. 801 et seq. The temporary scheduling of alpha-ethyltryptamine is not a major rule for the purposes of Executive Order (E.O.) 12291 of February 17, 1981. It has been determined that drug scheduling matters are not subject to review by the Office of Management and Budget (OMB) pursuant to the provisions of E.O. 12291. Accordingly, this proposed emergency scheduling action is not subject to provisions of E.O. 12778 which are contingent upon review by OMB. This regulation both responds to an emergency situation posing an imminent danger to the public safety, and is essential to a criminal law enforcement function of the United States. Accordingly, it is not subject to a moratorium on regulations ordered by the President of the United States in his memorandum of January 28, 1992, as amended. This action has been analyzed in accordance with the principles and criteria in E.O. 12291, and it has been determined that the temporary placement of alpha-ethyltryptamine into Schedule I of the CSA 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, Reporting and record keeping requirements. Under the authority vested in the Attorney General by section 201(h) of the CSA (21 U.S.C. 811(h)), and delegated to the Administrator of the DEA by Department of Justice regulations (28 CFR 0.100), the Administrator hereby intends to order 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 adding paragraph (g)(5) to read as follows: sec1308.11 Schedule I * * * * * (g) * * * (1) N-[1-benzyl-4-piperidyl]-N-phenylpropanamide (benzylfentanyl), 9818 its optical siomers, salts and salts of isomers. (2) N-[1-(2-thienyl)methyl-4-piperidyl]-N-phenylpropanamide 9834 (thenylfentanyl), its optical isomers, salts and salts of isomers. (5) alpha-ethyltryptamine, its optical isomers, salts and salts of 7249 isomers. Some other names: etryptamine; BETA-ethyl-1H-indole-3-ethanamine; 3-(2- aminobutyl) indole. Date: January 8, 1993. Robert C. Bonner, Administrator of Drug Enforcement. [FR Doc. 93-878 Filed 1-13-93; 8:45 am] BILLING CODE 4410-09-M