Date="04/28/93" Citation="58 FR 25790" Group="legal" Type="PROPOSED RULE" Department="DEPARTMENT OF JUSTICE" Agency="DRUG ENFORCEMENT ADMINISTRATION, JUSTICE" Subject="Schedules of Controlled Substances Proposed Transfer of Levo-alphacety lmethadol From Schedule I Into Schedule II"

------------------------------------------------------------ 21 CFR Part 1308 Schedules of Controlled Substances Proposed Transfer of Levo- alphacetylmethadol From Schedule I Into Schedule II AGENCY: Drug Enforcement Administration, Justice. ACTION: Notice of proposed rulemaking.

------------------------------------------------------------ 21 CFR Part 1308 Schedules of Controlled Substances Proposed Transfer of Levo- alphacetylmethadol From Schedule I Into Schedule II AGENCY: Drug Enforcement Administration, Justice. ACTION: Notice of proposed rulemaking. + ------------------------------------------------------------ SUMMARY: The Administrator of the Drug Enforcement Administration (DEA) is issuing this notice of proposed rulemaking to transfer the Schedule I narcotic, levo-alphacetylmethadol (LAAM), to Schedule II of the Controlled Substances Act (CSA) in accordance with 21 U.S.C. 801 et seq. This action is initiated upon receipt of a letter from the Acting Assistant Secretary for Health, Department of Health and Human Services (DHHS), recommending that LAAM be transferred from Schedule I to Schedule II upon approval of a New Drug Application (NDA) for LAAM. As a result of this proposed rule, if finalized, the regulatory controls and criminal sanctions of Schedule II will be applicable to the manufacture, distribution, importation and exportation of LAAM. Additionally, the use of LAAM for the treatment of narcotic addiction will be subject to compliance with the requirements of the Narcotic Addict Treatment Act of 1974 and regulations concerning narcotic treatment programs. DATES: Comments must be submitted on or before May 28, 1993. ADDRESSES: Comments should be submitted to the Administrator, Drug Enforcement Administration, Washington, DC 20537, Attention: DEA Federal Register Representative/CCR. 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 Acting Assistant Secretary for Health, on behalf of the Secretary of the DHHS, sent the Administrator of the DEA a letter recommending that levo-alphacetylmethadol be transferred to Schedule II of the CSA once it is approved for marketing. Enclosed with the letter was a document prepared by the Food and Drug Administration (FDA) entitled "Basis for the Recommendation for Transferring of Levo-alpha-acetylmethadol (LAAM) from Schedule I to II of the Controlled Substances Act." The document contained a review of the factors which the CSA requires the Secretary to consider (21 U.S.C. 811(b) and 811(c)) and the summarized recommendations regarding the transfer of LAAM. The factors considered by the Acting Assistant Secretary for Health with respect to LAAM are: (1) Its actual or relative potential for abuse; (2) Scientific evidence of its pharmacological effects, if known; (3) The state of the current scientific knowledge regarding the drug or other substance; (4) Its history and current pattern of abuse; (5) The scope, duration, and significance of abuse; (6) What, if any, risk there is to the public health; (7) Its psychic or physiological dependence liability; and (8) Whether the substance is an immediate precursor of a substance already controlled under this title. The FDA has received and reviewed substantial evidence on the effectiveness and safety of LAAM. The FDA's scientific and medical evaluation shows that LAAM has a potential for abuse and physical and psychological dependence liability similar to other MU-opioid agonists which are in Schedule II of the CSA. Upon approval of the NDA for treatment of narcotic addiction, LAAM will have met DEA's criteria for currently accepted medical use in treatment in the United States. These criteria were discussed at length in the matter of the Marijuana Rescheduling Petition, 57 FR 10499, 10503-10507 (1992). This transfer will apply to the levo isomer of alphacetylmethadol while all other isomers of alphacetylmethadol will remain in Schedule I. Interested persons are invited to submit their comments or objections in writing regarding this proposal. If a person believes that one or more issues warrant a hearing, the reasons for such belief should be stated and summarized. If the Administrator finds that the written responses to this proposal warrant a hearing, the Administrator will order a public hearing. A notice of the hearing will be published in the Federal Register summarizing the issues to be heard and setting a time for the hearing that will be at least 30 days after the publication of the notice. If no objections presenting grounds for a hearing on this proposal are received within the time limitation or if interested parties waive or are deemed to have waived their opportunity for a hearing or to participate in a hearing, the Administrator, after giving consideration to written comments and objections, will issue his final order pursuant to 21 CFR 1308.48 without a hearing. DEA's final decision concerning the relative abuse potential of LAAM will take into account the Acting Assistant Secretary's recommendation and any information received in response to this proposal. Pursuant to 5 U.S.C. 605(b), the Administrator certifies that the transfer of LAAM, as proposed herein, will have no significant impact upon small businesses or other entities whose interests must be considered under the Regulatory Flexibility Act (Pub. L. 96-354). Many of the regulatory requirements imposed on Schedule II substances are similar to those imposed on Schedule I substances. Additionally, substances in Schedule II may be used in medical treatment in the United States. This action has been analyzed in accordance with the principles and criteria contained in Executive Order 12612, and it has been determined that this matter does not have sufficient federalism implications to require the preparation of a Federalism Assessment. In accordance with the provisions of 21 U.S.C. 811(a), this proposal to transfer LAAM from Schedule I to Schedule II is a formal rulemaking "on the record after opportunity for hearing." Such proceedings are conducted pursuant to the provisions of 5 U.S.C. 556 and 557 and as such have been exempted from the consultation requirements for Executive Order 12291 (46 FR 13193). List of Subjects in 21 CFR Part 1308 Administrative practice and procedure, Drug traffic control, Narcotics, Prescription drugs, Reporting and Record keeping requirements. Based on the scientific and medical evaluation and the recommendation of the Acting Assistant Secretary for Health, the Administrator of the DEA, pursuant to 21 U.S.C. 811(a) and 811(b), finds that: (1) Based on all available information, LAAM has a high potential for abuse. (2) LAAM, upon final approval of a NDA by the FDA, will meet the criteria for currently accepted medical use in treatment in the United States. (3) Abuse of this substance may lead to severe psychological or physical dependence. Therefore, under the authority vested in the Attorney General (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 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, 871(b) unless otherwise noted. 2. Section 1308.11 is proposed to be amended by revising paragraph (b)(4) to read as follows: sec1308.11 Schedule I. * * * * * (b) * * * (4) Alphacetylmethadol (except Levo-alphacetylmethadol (LAAM))- 9603 * * * * * 3. Section 1308.12 is proposed to be amended by redesignating the existing paragraphs (c)(11) through (c)(25) as (c)(12) through (c)(26) respectively and adding a new paragraph (c)(11) to read as follows: sec1308.12 Schedule II. * * * * * (c) * * * (11) Levo-alphacetylmethadol (LAAM)-9648 * * * * * Dated: April 22, 1993. Robert C. Bonner, Administrator of Drug Enforcement. [FR Doc. 93-9946 Filed 4-27-93; 8:45 am] BILLING CODE 4410-09-M