Date="12/20/94" Citation="59 FR 65521" Group="legal" Type="PROPOSED RULE" Department="DEPARTMENT OF JUSTICE" Agency="DRUG ENFORCEMENT ADMINISTRATION, JUSTICE" Subject="Schedules of Controlled Substances; Proposed Placement of 4-Bromo-2,5- dimethoxyphenethylamine Into Schedule I"

DEPARTMENT OF JUSTICE Drug Enforcement Administration [DEA-126P] 21 CFR Part 1308 Schedules of Controlled Substances; Proposed Placement of 4- Bromo-2,5-dimethoxyphenethylamine Into Schedule I AGENCY: Drug Enforcement Administration, Justice. ACTION: Notice of proposed rulemaking.

DEPARTMENT OF JUSTICE Drug Enforcement Administration [DEA-126P] 21 CFR Part 1308 Schedules of Controlled Substances; Proposed Placement of 4- Bromo-2,5-dimethoxyphenethylamine Into Schedule I AGENCY: Drug Enforcement Administration, Justice. ACTION: Notice of proposed rulemaking. + ------------------------------------------------------------ SUMMARY: This notice of proposed rulemaking is issued by the Deputy Administrator of the Drug Enforcement Administration (DEA) to place 4-bromo-2,5-dimethoxyphenethylamine (4-bromo- 2,5-DMPEA) into Schedule I of the Controlled Substances Act (CSA). This proposed action by the DEA Deputy 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 4-bromo-2,5-DMPEA. DATES: Comments must be submitted on or before January 19, 1995. ADDRESSES: Comments and objections should be submitted to the Deputy Administrator, Drug Enforcement Administration, Washington, D.C. 20537, Attention: DEA Federal Register Representative. FOR FURTHER INFORMATION CONTACT: Howard McClain, Jr., Chief, Drug and Chemical Evaluation Section, Drug Enforcement Administration, Washington, D.C. 20537, Telephone: (202) 307-7183. SUPPLEMENTARY INFORMATION: On January 6, 1994, the Acting Administrator of the DEA published a final rule in the Federal Register (59 FR 671) amending sec 1308.11(g) of Title 21 of the Code of Federal Regulations to temporarily place 4-bromo-2,5-DMPEA 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 Acting Administrator that the temporary scheduling of 4-bromo-2,5-DMPEA 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 4-bromo-2,5- DMPEA which would expire on January 6, 1995, may be extended to July 6, 1995. This extension is being ordered by the DEA Deputy 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 4-bromo-2,5-DMPEA. The Deputy 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 Deputy Administrator also requested a scientific and medical evaluation and a scheduling recommendation for 4-bromo-2,5-DMPEA from the Assistant Secretary for Health. The Food and Drug Administration (FDA) 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 4-bromo- 2,5-DMPEA. A search of the scientific and medical literature revealed no indications of current medical use of 4-bromo-2,5- DMPEA in the United States. 4-bromo-2,5-DMPEA is structurally similar to the Schedule I phenylisopropylamine hallucinogens, 4-bromo-2,5-dimethoxyphenethylamine (DOB). Like DOM and DOB, 4-bromo-2,5-DMPEA displays high affinity for central serotonin receptors and is capable of substituting for DOM or DOB in drug discrimination studies conducted in rats. These data suggest that 4-bromo-2,5-DMPEA is a psychoactive substance capable of producing effects similar, though not identical, to DOM and DOB. Data from human studies indicate that 4-bromo- 2,5-DMPEA is orally active at 0.1-0.2 mg/kg producing an intoxication with considerable euphoria and sensory enhancement which lasts for 6 to 8 hours. Higher doses have been reported to produce intense and frightening hallucinations. The DEA first encountered 4-bromo-2,5-DMPEA in 1979. Since that time, several exhibits of 4-bromo-2,5-DMPEA have been analyzed by Federal and state forensic laboratories in Arizona, California, Colorado, Georgia, Illinois, Iowa, Kentucky, Oregon, Pennsylvania and Texas. Clandestine laboratories producing 4-bromo-2,5-DMPEA were seized in California in 1986 and 1994 and in Arizona in 1992. It has been represented as 3,4-methylenedioxy-methamphetamine (MDMA) and has been sold in sugar cubes as LSD. Recently, 4- bromo-2,5-DMPEA has been promoted as an aphrodisiac and distributed under the product name of Nexus. DEA has seized several thousand dosage units of this product. The Deputy 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 4-bromo-2,5-DMPEA 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 Deputy 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 Deputy 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 Deputy Administrator, Drug Enforcement Administration, Washington, D.C. 20537, Attention: DEA Federal Register Representative. In the event that comments, objections, or requests for a hearing raise one or more issues which the Deputy Administrator finds warrants 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. The Deputy Administrator of the DEA hereby certifies that proposed placement of 4-bromo-2,5-DMPEA 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, Section 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) 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 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)(3) through (d)(30) as (d)(4) through (d)(31) and adding a new paragraph (d)(3) to read as follows: sec 1308.11 Schedule I. * * * * * (d) * * * (3) 4-Bromo-2,5-dimethoxyphenethylamine-7392 Some trade or other names: 2-(4-bromo-2,5-dimethoxyphenyl)- 1-aminoethane; alpha-desmethyl DOB; 2C-B, Nexus. 3. Section 1308.11 is further amended by removing paragraph (g)(3). Dated: December 13, 1994. Stephen H. Greene, Deputy Administrator. [FR Doc. 94-31162 Filed 12-19-94; 8:45 am] BILLING CODE 4410-09-M ------------------------------------------------------ The Contents entry for this article reads as follows: Schedules of controlled substances: 4-Bromo-2, 5-dimethoxyphenethylamine, 65521