[Federal Register: April 9, 1999 (Volume 64, Number 68)]
[Proposed Rules]               
[Page 17298-17299]
From the Federal Register Online via GPO Access [wais.access.gpo.gov]
[DOCID:fr09ap99-11]

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DEPARTMENT OF JUSTICE

Drug Enforcement Administration

21 CFR Part 1308

[DEA-182N]

 
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.

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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.

[[Page 17299]]

    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DATES: The proposed rule is withdrawn on April 9, 1999.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,
Deputy Administrator.
[FR Doc. 99-8812 Filed 4-8-99; 8:45 am]
BILLING CODE 4410-09-M