[Federal Register Volume 65, Number 83 (Friday, April 28, 2000)]
[Notices]
[Pages 24969-24970]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 00-10631]
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DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
[Docket No. 00N-1257]
International Drug Scheduling; Convention on Psychotropic
Substances; 4-Bromo-2,5-dimethoxyphenethylamine (2C-B); Gamma-
hydroxybutyric acid (GHB); 4-Methylthioamphetamine (4-MTA); N-Methyl-1-
(3,4-methylenedioxyphenyl)-2-butanamine (MBDB); Diazepam (INN);
Zolpidem (INN)
AGENCY: Food and Drug Administration, HHS.
ACTION: Notice.
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SUMMARY: The Food and Drug Administration (FDA) is requesting
interested persons to submit comments concerning abuse potential,
actual abuse, medical usefulness, and trafficking of six drug
substances. These comments will be considered in preparing a response
from the United States to the World Health Organization (WHO) regarding
the abuse liability and diversion of these drugs. WHO will use this
information to consider whether to recommend that certain international
restrictions be placed on these drugs. This notice requesting comments
is required by the Controlled Substances Act (CSA).
DATES: Submit written comments by May 15, 2000.
ADDRESSES: Submit written comments to the Dockets Management Branch
(HFA-305), Food and Drug Administration, 5630 Fishers Lane, rm. 1061,
Rockville, MD 20852.
FOR FURTHER INFORMATION CONTACT: Corinne P. Moody, Center for Drug
Evaluation and Research (HFD-009), Food and Drug Administration, 5600
Fishers Lane, Rockville, MD 20857, 301-827-1999, e-mail:
[email protected].
SUPPLEMENTARY INFORMATION: The United States is a party to the 1971
Convention on Psychotropic Substances. Article 2 of the Convention on
Psychotropic Substances provides that if a party to the convention or
WHO has information about a substance, which in its opinion may require
international control or change in such control, it shall so notify the
Secretary General of the United Nations and provide the Secretary
General of the United Nations with information in support of its
opinion.
The CSA (21 U.S.C. 811 et seq.) (Title II of the Comprehensive Drug
Abuse Prevention and Control Act of 1970) provides that when WHO
notifies the United States under Article 2 of the Convention on
Psychotropic Substances that it has information that may justify adding
a drug or other substances to one of the schedules of the convention,
transferring a drug or substance from one schedule to another, or
deleting it from the schedules, the Secretary of State must transmit
the notice to the Secretary of Health and Human Services (the Secretary
of HHS). The Secretary of HHS must then publish the notice in the
Federal Register and provide opportunity for interested persons to
submit comments that will be considered by HHS in its preparation of
the scientific and medical evaluations of the drug or substance. The
Secretary of HHS received the following notices from WHO:
I. WHO Notification
Ref.: C.L.1.2000
WHO questionnaire for collection of information for review of
dependence-producing psychoactive substances.
The Director-General of the World Health Organization presents
her compliments and has the pleasure of informing Member States that
the Thirty-second Expert Committee on Drug Dependence (ECDD) will
meet from 11 to 14 September 2000 to review the following
substances:
1. 4-Bromo-2,5-dimethoxyphenethylamine (2C-B)
2. Gamma-hydroxybutyric acid (GHB)
3. 4-Methylthioamphetamine (4-MTA)\1\
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\1\ If the reply to the questionnaire confirms a medical use of
4-MTA recognized by any Member State, the substance will be
subjected to a prereview instead of a critical review.
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4. N-Methyl-l-(3,4-methylenedioxyphenyl)-2-butanamine (MBDB)
5. Diazepam (INN)
6. Zolpidem (INN)
One of the essential elements of the established review
procedure is for the Secretariat to collect relevant information
from Member States to prepare a Critical Review document for
submission to the Expert Committee on Drug Dependence. The World
Health Organization invites Member States to collaborate, as in the
past, in this process by providing pertinent information mentioned
in the attached questionnaire\2\ concerning the substances listed
above.
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\2\ For Ministries of Health only.
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Further clarification on any of the above items can be obtained
from Quality Assurance and Safety: Medicines (QSM), Essential Drugs
and Medicines Policy (EDM), WHO, Geneva, to which replies should be
sent not later than 1 May 2000.
[[Page 24970]]
GENEVA, 12 January 2000
WHO Questionnaire for review of dependence-producing psychoactive
substances by the Thirty-second Expert Committee on Drug Dependence.
Substance reported on:
1. Availability of the substance (registered, marketed,
dispensed, etc.);
2. Extent of the abuse or misuse\3\ of the substance;
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\3\ In this questionnaire, ``abuse or misuse'' refers to use of
the substance other than for medical or scientific purposes.
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3. Degree of seriousness of the public health and social
problems associated with the abuse of the substance (statistics on
cases of overdose deaths, dependence, etc.); and
4. Any information on the nature and extent of illicit
activities involving the substance (clandestine manufacture,
smuggling, diversion, seizure, etc.).
In addition to the above, with regard to Diazepam (INN) report
on:
5. The impact of transferring diazepam from Schedule IV to
Schedule III of the Convention on Psychotropic Substances, 1971, and
its effect on availability for medical use.
In addition to items 1 to 4 above, with regard to Zolpidem (INN)
report on:
6. The impact of placing zolpidem in Schedule IV of the
Convention on Psychotropic Substances, 1971, and its effect on
availability for medical use.
II. Background
The substance 4-Bromo-2,5-dimethoxyphenethylamine (2C-B) is a
structural analogue of the phenethylamine hallucinogens. In various
preclinical and clinical studies, it has been described as a stimulant,
depressant, and hallucinogen, but appears to more closely fit the
profile of the latter. It is not marketed in the United States,
however, it is controlled domestically in Schedule I of the CSA.
Gamma-hydroxybutyric acid (GHB) is a substance classified as a
central nervous system depressant. It is not marketed in the United
States. The Drug Enforcement Administration published a final rule on
March 13, 2000 (65 FR 13235), placing gamma-hydroxybutyric acid and its
salts, isomers, and salts of isomers into Schedule I of the CSA under
Public Law 106-172. The final rule imposes Schedule III security
requirements for registered manufacturers and distributors of GHB when
it is manufactured, distributed, or possessed in accordance with FDA
authorized investigational new drug exemptions under section 505(i) of
the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 355(i)). If drug
products containing GHB are approved by FDA, the final rule places FDA
approved products containing GHB into Schedule III of the CSA under
Public Law 106-172.
The substance 4-Methylthioamphetamine (4-MTA) is a compound
structurally similar to amphetamine. 4-MTA is reported to have
physiological effects similar to that of 3,4-methylenedioxyamphetamine
(MDA) and 3,4-methylenedioxymethamphetamine (MDMA/ecstasy). The
substance is not marketed in the United States. It is not specifically
listed as a controlled substance in the United States. However, it is
considered a Schedule I controlled substance as an analogue of either
MDA or MDMA under the analogue provisions of the CSA.
N-Methyl-l-(3,4-methylenedioxyphenyl)-2-butanamine (MBDB) is a
positional isomer of MDE (3,4-methylenedioxy-N-ethylamphetamine) which
is controlled domestically in Schedule I. The psychoactive effects of
MBDB have been described as hallucinogenic. It is not marketed in the
United States. As an isomer of MDE, MBDB is a Schedule I substance in
the United States.
Diazepam (INN) is a benzodiazepine derivative. It is marketed in
the United States for the management of anxiety disorders or for the
short-term relief of the symptoms of anxiety; in acute alcohol
withdrawal, it is used in the symptomatic relief of acute agitation,
tremor, impending or acute delirium tremens, and hallucinosis; as an
adjunct for the relief of skeletal muscle spasm; spasticity caused by
upper motor neuron disorders; athetosis; stiff-man syndrome; tetanus;
as an adjunct in convulsive disorders; and as a premedication for
relief of anxiety and tension in patients who are to undergo surgical
procedures. Domestically, it is controlled in Schedule IV of the CSA.
Diazepam is controlled internationally in Schedule IV of the
Psychotropic Convention.
Zolpidem (INN) is a hypnotic agent with a chemical structure
unrelated to benzodiazepines, barbiturates, or other drugs with known
hypnotic properties. It interacts with a GABA-BZ receptor complex and
shares some of the pharmacological properties of the benzodiazepines.
It is marketed in the United States for the short-term treatment of
insomnia. Domestically, it is controlled in Schedule IV of the CSA.
III. Opportunity to Submit Domestic Information
As required by section 201(d)(2)(A) of the CSA (21 U.S.C. 811
(d)(2)(A)), FDA, on behalf of the Department of Health and Human
Services (DHHS), invites interested persons to submit comments
regarding the six named drugs. Any comments received will be considered
by DHHS when it prepares a scientific and medical evaluation of these
drugs. DHHS will forward a scientific and medical evaluation of these
drugs to WHO, through the Secretary of State, for WHO's consideration
in deciding whether to recommend international control/decontrol of any
of these drugs. Such control could limit, among other things, the
manufacture and distribution (import/export) of these drugs and could
impose certain recordkeeping requirements on them.
DHHS will not now make any recommendations to WHO regarding whether
any of these drugs should be subjected to international controls.
Instead, DHHS will defer such consideration until WHO has made official
recommendations to the Commission on Narcotic Drugs, which are expected
to be made in late 2000. Any DHHS position regarding international
control of these drugs will be preceded by another Federal Register
notice soliciting public comments as required by 201(d)(2)(B) of the
CSA.
IV. Comments
Interested persons may submit to the Dockets Management Branch
(address above) written comments regarding the drugs by May 15, 2000.
This abbreviated comment period is necessary to allow sufficient time
to prepare and submit the domestic information package by the deadline
imposed by WHO. Two copies of any comments are to be submitted, except
that individuals may submit one copy. Comments are to be identified
with the docket number found in brackets in the heading of this
document. Received comments may be seen in the Dockets Management
Branch between 9 a.m. and 4 p.m., Monday through Friday.
Dated: April 24, 2000.
Margaret M. Dotzel,
Acting Associate Commissioner for Policy.
[FR Doc. 00-10631 Filed 4-27-00; 8:45 am]
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