[Federal Register Volume 64, Number 68 (Friday, April 9, 1999)]
[Proposed Rules]
[Pages 17298-17299]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 99-8812]
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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DATES: The proposed rule is withdrawn on April 9, 1999.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
