Rules - 1999
WAIS Document Retrieval
[Federal Register: April 9, 1999 (Volume 64, Number 68)]
From the Federal Register Online via GPO Access [wais.access.gpo.gov]
DEPARTMENT OF JUSTICE
Drug Enforcement Administration
Schedules of Controlled Substances: Proposed Placement of Ketamine Into Schedule III
AGENCY: Drug Enforcement Administration, Department of Justice.
ACTION: Notice of withdrawal of proposed rule.
SUMMARY: The Drug Enforcement Administration (DEA) is withdrawing a Notice of Proposed Rulemaking (NPRM) which was published on June 2, 1981 (46 FR 29484). This NPRM proposed the placement of the substance ketamine, and salts thereof, into Schedule III of the Controlled Substances Act (CSA). In 1981, however, the DEA concluded that evidence of actual abuse was not sufficient to proceed with the rulemaking process. The DEA did not withdraw the NPRM, but continued to monitor the diversion and abuse of the drug. In light of additional evidence, the DEA now has sufficient data to proceed with the control of ketamine.
So as to eliminate any confusion which may arise regarding the basis of the proposed action, the DEA is withdrawing the original NPRM (46 FR 29484) and under a separate notice in this issue of the Federal Register, the DEA is publishing a new NPRM which proposes the placement of the substance ketamine, its salts, isomers, and salts of isomers, into Schedule III of the CSA.
DATES: The proposed rule is withdrawn on April 9, 1999.
FOR FURTHER INFORMATION CONTACT: Frank Sapienza, Chief, Drug and Chemical Evaluation Section, Drug Enforcement Administration, Washington, D.C. 20537; Telephone: 202-307-7183; FAX: 202-307-8570.
SUPPLEMENTARY INFORMATION: On June 2, 1981, the DEA published a notice of proposed rulemaking (NPRM) in the Federal Register (46 FR 29484). The NPRM proposed to add the noncontrolled substance ketamine and any salts thereof to Schedule III of the Controlled Substances Act (21 U.S.C. 801 et seq.). The DEA received seven letters in response to the NPRM. Comments in support of the proposed action were received from the American Veterinary Medical Association and a professor at the Texas A & M University, College of Veterinary Medicine. Comments in opposition were received from the Warner-Lambert Company, the Humane Society of the United States, the Division of Comparative Medicine at the Johns Hopkins University School of Medicine, the Department of Laboratory Animal Medicine at the Southwest Foundation for Research and Education, and the Director of Scientific Support Services, Primate Research Institute at the New Mexico State University. No requests for a hearing were received.
The DEA, after careful consideration, determined to postpone proceeding with the proposed regulatory action. While the substance's potential for abuse was established, the DEA concluded that the number of documented cases of abuse of the substance was insufficient to justify the regulatory action in 1981. The DEA did not withdraw the NPRM and terminate further rulemaking on the proposal, but continued to monitor the diversion and abuse of ketamine. In 1992, an increase in the number of cases of diversion and abuse was first noted. Elsewhere in this issue of the Federal Register, the DEA publishes a new NPRM, which results from the current experience as it relates to the diversion and abuse of ketamine. So as to eliminate any confusion which might arise regarding the basis of the proposed action, the DEA is withdrawing the 1981 NPRM (46 FR 29484 June 2, 1981) and terminating further rulemaking on this proposal.
Dated: April 2, 1999.
Donnie R. Marshall,
[FR Doc. 99-8812 Filed 4-8-99; 8:45 am]
BILLING CODE 4410-09-M
NOTICE: This is an unofficial version. An official version of this publication may be obtained directly from the Government Publishing Office (GPO).