Date="11/24/92" Citation="57 FR 55201" Group="legal" Type="PROPOSED RULE" Department="DEPARTMENT OF JUSTICE" Agency="DRUG ENFORCEMENT ADMINISTRATION, JUSTICE" Subject="Schedules of Controlled Substances; Proposed Placement of Zolpidem Int o Schedule IV"

DEPARTMENT OF JUSTICE Drug Enforcement Administration 21 CFR Part 1308 Schedules of Controlled Substances; Proposed Placement of Zolpidem Into Schedule IV 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 Zolpidem Into Schedule IV AGENCY: Drug Enforcement Administration, Justice. ACTION: Notice of proposed rulemaking. ------------------------------------------------------------ SUMMARY: This proposed rule places the drug, zolpidem, into Schedule IV of the Controlled Substances Act (CSA). The Administrator of the Drug Enforcement Administration (DEA) has received a recommendation from the Department of Health and Human Services (DHHS) that zolpidem be controlled in Schedule IV. DATES: Comments must be submitted on or before December 24, 1992. ADDRESSES: Comments and objections should be submitted to: 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 September 15, 1992, the Administrator of the DEA received a letter from the Assistant Secretary for Health, acting on behalf of the Secretary of the DHHS, recommending that zolpidem be placed in Schedule IV of the CSA (Title II of the Comprehensive Drug Abuse Prevention and Control Act of 1970 (21 U.S.C. 801-996)). Enclosed with this letter from the Assistant Secretary was a document which listed the factors which the Act requires the Secretary to consider and the summarized considerations of the Secretary in recommending control for zolpidem. In his letter, the Assistant Secretary recommended, further, that this scheduling action become effective if and when the zolpidem New Drug Application (NDA) receives final approval by the Food and Drug Administration (FDA). The factors considered by the Assistant Secretary for zolpidem were: (1) Its actual or relative potential for abuse; (2) Scientific evidence of its pharmacological effect, if known; (3) The state of 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 the CSA. Relying on the scientific and medical evaluation and the recommendation of the Assistant Secretary of Health, received in accordance with section 201(f) of the Act (21 U.S.C. 811(f)), the Administrator of the DEA, pursuant to sections 201(a) and 201(b) of the Act (21 U.S.C. 811(a) and 811(b)), finds that: (1) Based on information now available, zolpidem has a low potential for abuse relative to the drugs or other substances currently listed in Schedule III; (2) Zolpidem will, upon issuance of a NDA by the FDA, have a currently accepted medical use in treatment in the United States; and (3) Abuse of zolpidem may lead to limited physical dependence or psychological dependence relative to the drugs or other substances in Schedule III. 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 warrant 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. In accordance with the provisions of the CSA (21 U.S.C. 811(a)), this action is a formal rulemaking "on the record after opportunity for a hearing." Such proceedings are conducted pursuant to the provisions of 5 U.S.C. 556 and 557 and, as such, are exempted from the consultation requirements of Executive Order 12291 (46 FR 13193) and are outside the scope of the Regulatory Flexibility Act, 5 U.S.C. 601, et seq. This action has been analyzed in accordance with the principles and criteria in Executive Order 12612 (52 FR 41685), and it has been determined that this matter 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 Department of Justice Regulations (28 CFR 0.100), the Administrator hereby proposes that 21 CFR part 1308 be amended as follows: PART 1308-[AMENDED] 1. The authority citation for part 1308 continues to read as follows: Authority: 21 U.S.C. 811, 812, 871(b), unless otherwise noted. 2. Section 1308.14 is amended to add a new paragraph (c)(48) to read as follows: sec1308.14 Schedule IV. * * * * * (c) * * * (48) Zolpidem * * * * * Dated: November 13, 1992. Robert C. Bonner, Administrator of Drug Enforcement. [FR Doc. 92-28306 Filed 11-23-92; 8:45 am] BILLING CODE 4410-09-M