[Federal Register Volume 59, Number 117 (Monday, June 20, 1994)]
[Unknown Section]
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From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 94-14962]
[[Page Unknown]]
[Federal Register: June 20, 1994]
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DEPARTMENT OF HEALTH AND HUMAN SERVICES
[Docket No. 94N-0173]
International Drug Scheduling; Convention on Psychotropic
Substances; Certain Stimulant/Hallucinogenic Drugs and Certain
Nonbarbiturate Sedative Drugs
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 data or comments concerning abuse
potential, actual abuse, medical usefulness, and trafficking of eight
drug substances. This information will be considered in preparing a
response from the United States to the World Health Organization (WHO)
regarding abuse liability, actual abuse, and trafficking 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 information is required by the Controlled Substances
Act (the CSA).
DATES: Comments by July 20, 1994.
ADDRESSES: Written comments to the Dockets Management Branch (HFA-305),
Food and Drug Administration, rm. 1-23, 12420 Parklawn Dr., Rockville,
MD 20857.
FOR FURTHER INFORMATION CONTACT: Nicholas P. Reuter, Office of Health
Affairs (HFY-20), Food and Drug Administration, 5600 Fishers Lane,
Rockville, MD 20857, 301-443-1382.
SUPPLEMENTARY INFORMATION: The United States is a party to the 1971
Convention on Psychotropic Substances (the Convention). Article 2 of
the Convention provides that if a party to that 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 (the Secretary-General) and
provide the Secretary-General 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 the United
Nations notifies the United States under Article 2 of the Convention
that it has information that may justify adding a drug or other
substance to one of the schedules of that 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 (HHS). The Secretary of HHS must
then publish the notice in the Federal Register and provide opportunity
for interested persons to submit comments to assist HHS in preparing
scientific and medical evaluations about the drug or substance. The
Secretary of HHS received the following notices from WHO on behalf of
the Secretary-General:
I. WHO Notifications
A. Notification on Methcathinone
Reference:
NAR/CL.1/1994 CU 94/65
TIL-CND-101/94
UNDCP 421/12(1) 1971 CPS
WHO/ECDD
The Secretary-General of the United Nations presents his
compliments to the Secretary of State of the United States of
America and has the honour to inform the Government that pursuant to
article 2, paragraph 1, of the Convention on Psychotropic
Substances, 1971, the Government of the United States of America has
informed him that it is of the opinion that 2-(methylamino)-1-
phenylpropan-1-one (hereinafter referred to as methcathinone),
should be included in Schedule I of that Convention.
In accordance with the provisions of article 2, paragraph 2, of
the Convention, the Secretary-General hereby transmits the
notification in question as annex I to the present note. The
information submitted by the Government of the United States of
America in support of that notification is reproduced as annex II.
The present notification has also been transmitted to the World
Health Organization pursuant to article 2, paragraph 2, of the
Convention, for consideration by the 29th WHO Expert Committee on
Drug Dependence which is expected to examine this proposal in
September 1994. The WHO Expert Committee on Drug Dependence is
responsible for making scheduling recommendations to the Director-
General of WHO.
In accordance with article 2, paragraph 5, of the Convention,
any recommendation made by the World Health Organization will be
brought to the attention of the Commission on Narcotic Drugs. Any
action or decision taken by the Commission with respect to this
notification will be notified to States Parties in due course.
Article 2, paragraph 5, reads as follows:
``5. The Commission, taking into account the communication from
the World Health Organization, whose assessments shall be
determinative as to medical and scientific matters, and bearing in
mind the economic, social, legal, administrative and other factors
it may consider relevant, may add the substance to Schedule I, II,
III or IV. The Commission may seek further information from the
World Health Organization or from other appropriate sources.''
The Secretary-General would appreciate if the Government would
submit data on methcathinone following the outline contained in the
questionnaire attached to the present note as annex III.
Data provided by Governments will be used by WHO in the
preparation of a document to assist the Expert Committee in the
examination of this proposal. It would therefore be very much
appreciated if any comments which the Government may wish to make
with respect to this proposal could be sent to the Secretary-General
by 15 June 1994 at the latest. Replies should be addressed to the
Executive Director of the United Nations International Drug Control
Programme, c/o Secretariat of the Commission on Narcotic Drugs,
Vienna International Centre, P.O. Box 500, A-1400 Vienna, Austria,
fax 239397.
10 March 1994
ANNEX I
10 January 1994
Notification Under Article 2, Paragraph 1, of the 1971 Convention
on Psychotropic Substances
Subject: Addition of a substance to one of the Schedules annexed
to the Convention
The Government of the United States of America, being a Party to
the 1971 Convention on Psychotropic Substances, has information
relating to the following substance which is not yet under
international control, but which, in the Government's opinion, may
require its addition to one of the Schedules of the 1971 Convention
on Psychotropic Substances.
The substance is known by the names of N-methylcathinone,
methcathinone, ephedrone and monomethylpropion. Its chemical name is
2-(methylamino)-1-phenylpropan-1-one and its chemical formula is
C10H13NO.
In the Government's opinion, the above substance should be added
to Schedule I of that Convention.
The Government of the United States of America transmits this
notification to the Secretary-General of the United Nations, in
accordance with paragraph 1 of article 2 of the 1971 Convention on
Psychotropic Substances, in order to initiate the procedure provided
for under that article.
The relevant information in support of this notification is
annexed hereto.
ANNEX II
METHCATHINONE
Clandestine production, abuse and trafficking data
Over the past three years a new drug, called methcathinone, has
appeared in the illicit drug market in the United States. Results of
animals studies indicate that this drug is a central nervous system
stimulant with a significant potential of abuse. This is supported
by the anecdotal information that has been collected on its pattern
of abuse, by the effects produced and by the documented spread of
abuse of the drug in the United States. On 1 May 1993, methcathinone
was placed in Schedule I of the United States Controlled Substances
Act (the CSA). The Drug Enforcement Administration (DEA) is now
aware that methcathinone is a drug of abuse in a number of other
countries, particularly the Russian Federation and some of the newly
independent States of the former Union of Soviet Socialist Republics
(USSR). Methcathinone is not currently scheduled at an International
level. Considering that methcathinone abuse has been documented in a
number of countries, this drug should be examined for possible
international control under the Convention on Psychotropic
Substances of 1971\1\.
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\1\United Nations, Treaty Series, vol. 1019, No. 14956
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Methcathinone is a structural analogue of cathinone and
methamphetamine. The similarity in chemical structure between
methcathinone and the other two compounds is shown in the figure
below. Methcathinone differs from cathinone in having a methyl group
in place of hydrogen attached to the terminal nitrogen atom of the
isopropylamine side chain. Methcathinone differs from
methamphetamine in having a ketone group instead of a methylene
group at the beta carbon position of the phenylalkylamine molecule.
All forms of methamphetamine have been controlled in Schedule II of
CSA since 1971. Cathinone was placed in Schedule I of the CSA on 14
January 1993. Cathinone and methamphetamine are currently in
Schedules I and II, respectively, of the 1971 Convention.
TN20JN94.087
Various names for methcathinone include 2-(methylamino)-
propiophenone, -(methylamino)-propiophenone, -N-
methylaminopropiophenone, 2-(methylamino)-1-phenylpropan-1-one,
monomethylpropion, N-methylcathinone, N-monomethylcathinone,
methylcathinone, AL-464 (1 isomer), AL-422 (racemate), AL-463 (d-
isomer), UR1431 and UR(W)1431. In Europe, methcathinone is primarily
known as ephedrone. Methcathinone has a single asymmetric carbon
atom, thus yielding enantiomeric + and - forms. Chemical Abstract
Services registry numbers for the racemic base and hydrochloride
forms are 5650-44-2 and 49656-78-2, respectively. The Chemical
Abstract Services registry numbers for the base and hydrochloride
forms of the S absolute stereochemical configuration are 112117-24-5
and 66514-93-0, respectively. The molecular formula for
methcathinone is C10H13NO. The molecular weight of
methcathinone hydrochloride is 199.67.
In preclinical studies, methcathinone hydrochloride produces
pharmacological effects and appears to have an abuse potential
similar to that of the amphetamines. Methcathinone hydrochloride
increases spontaneous rodent locomotor activity, potentiates the
release of radio-labelled dopamine from dopaminergic nerve terminals
in the brain, and causes appetite suppression. In drug
discrimination studies, methcathinone hydrochloride evokes responses
similar to those induced by both (+)-amphetamine sulphate and
cocaine hydrochloride. When examined in particular pharmacological
assays for psychomotor stimulant-like activity, both the d and l
enantiomeric forms of methcathinone hydrochloride have been found to
be pharmacologically active. In these assays, the l-form of
methcathinone is more active than either d-methcathinone or (+)-
amphetamine. Racemic methcathinone hydrochloride is intravenously
self-administered by baboons, thus indicating that methcathinone
produces reinforcing effects in this laboratory animal, and
suggesting that the drug has a potential for abuse in the human
population.
A survey of the scientific and medical literature has not
revealed any studies examining the pharmacological effects of
methcathinone in humans. Parke Davis, who initially did preclinical
studies of methcathinone in the United States in the early and mid-
1950s, subsequently elected to abandon the drug prior to performing
any clinical studies. Methcathinone has never been approved for
legitimate medical use in the United States. Currently, DEA is not
aware of any legitimate medical uses for methcathinone in other
countries. The limited knowledge of the pharmacology of
methcathinone in humans comes from anecdotal evidence of
methcathinone abuse and from several papers published in journals in
the Russian Federation and documenting methcathinone (ephedrone)
abuse in that country. This information indicates that in humans
methcathinone produces stimulant effects on the central nervous
system similar to those produce by amphetamines and cocaine.
To date, the abuse of methcathinone has been documented in
Michigan, Wisconsin, Indiana, Illinois and Missouri. This abuse is
believed to have originated at Ann Arbor, Michigan, in 1989. Since
then, methcathinone abuse in Michigan has increased substantially,
almost exclusively in the Upper Peninsula of that state.
Methcathinone abuse spread from Michigan into Wisconsin sometime in
late 1992. A number of drug abuse treatment centres in Michigan, as
well as several drug and psychiatric treatment centres in Wisconsin,
have reported encounters with methcathinone abusers. In addition,
there have been a number of documented emergency-room cases
involving the purported abuse of methcathinone. Data from federal,
state and local law enforcement agencies indicate methcathinone
abuse in Michigan and Wisconsin, which subsequently spread to
Indiana, Illinois and Missouri. Individuals abusing methcathinone
have been primarily whites with limited educational backgrounds and
financial means. In addition, they tend to be polysubstance abusers,
having abuse experience with alcohol, marijuana, stimulants (that
is, methamphetamine and cocaine) and/or other drugs.
The principal form of methcathinone distributed and abused is
the hydrochloride salt of the l-enantiomer, which exists as a chunky
powdered material, white to off-white in colour. It is usually sold
as itself under such street names as ``Cat'' and ``Goob''. Less
often it is passed off as methamphetamine under such names as
``Crank'', ``Speed'', ``Slick Superspeed'', ``Bathtub speed'' and
``Cadillac Express''. It is usually sold in quantities of one fourth
of a gram, 1 gram, 3.5 grams (``8-ball'') or an ounce (28.35 grams).
The powdered material comes packaged in paper packets (called
bindles), vials and plastic bags. Street prices are in the vicinity
of 20.00 United States dollars (US$) to US$ 25.00 for one fourth of
a gram, US$ 100.00 for 1 gram, and US$ 200 to US$ 250.00 for an ``8-
ball''.
Anecdotal reports have provided some information on patterns of
methcathinone abuse. The most common route of administration is via
nasal insufflation (snorting). Other routes of administration
include oral ingestion, intravenous injection and smoking.
Methcathinone is abused in binges lasting two to six days. During
binges experienced users will administer methcathinone at doses
ranging from one sixteenth to one fourth or a gram. The interval
between dosing varies between approximately 20 minutes and two
hours. With such a dosing regimen, during a binge methcathinone may
be administered in daily amounts exceeding 1 or 2 grams. The
principal determinant defining the length of the binge is the amount
of drug available; that is, the binge ends only when the available
supply of drug runs out. The methcathinone binge resembles
amphetamine binges in that the abuser does not sleep or eat, and
takes in little in the way of liquids. The methcathinone binge is
followed by a ``crash'' characterized by long periods of sleep,
excess eating and, in some cases, depression with or without
thoughts of suicide.
Methcathinone is abused for its psychomotor stimulant effects.
It is reported by abusers to produce such desirable effects as a
``burst of energy'', ``head rush'', ``body rush'', a ``speeding of
the mind'', and ``increased feeling of self-confidence'' and
``euphoria''. Methcathinone abusers with experience in the abuse of
other stimulants have reported that the effects produced by
methcathinone are qualitatively similar to those produced by
methamphetamine and/or cocaine. The head rush and body rush are much
more intense following intravenous administration than snorting. The
onset of action has been reported to occur around one to two minutes
following intravenous injection and 5 to 15 minutes following
snorting. Duration of action may vary from 30 minutes to about two
hours.
Methcathinone abuse is associated with the production of adverse
effects. Abusers have anecdotally reported that methcathinone
produces unpleasant effects such as paranoia, hallucinations,
anxiety, tremor, insomnia, malnutrition, weight loss, dehydration,
sweating, stomach pains, nose-bleeding and body aches. At least four
emergency-room encounters with presumed methcathinone abusers have
been documented in Michigan. In three of these cases, intravenous
administration was the route of administration. In the other case,
the drug was smoked. Adverse effects observed in one or more of the
four cases included agitation, excitement, hallucinations, elevated
temperature, chills, elevated blood temperature, increased heart
rate, tremor, back and/or abdominal pain and hypotension. All
effects subsided within 24 to 48 hours. Complete recovery occurred
in all four cases. In these cases, methcathinone use was presumed to
be based upon the descriptions of drug use given by the patients. In
the absence of an established analytical procedure to measure
methcathinone levels in biological fluids, analysis of methcathinone
in fluid samples from the cases was not attempted. In two of the
cases ephedrine and phenylpropanolamine, known metabolites of
methcathinone, were detected in urine.
Methcathinone hydrochloride is produced for street distribution
in clandestine laboratories. Between June 1991 and August 1993, 27
active or inactive clandestine methcathinone laboratories were
seized by federal, state and local law enforcement officials in
Michigan. Since January 1993, at least five clandestine
methcathinone laboratories have been encountered in Wisconsin. In
August 1992 a clandestine methcathinone laboratory was seized in
Seattle, Washington. In June 1993 a clandestine methcathinone
laboratory was seized in Illinois. In September 1993 four
clandestine methcathinone laboratories were seized in Indiana.
In the United States, methcathinone is synthesized via the
oxidation of l-ephedrine using sodium dichromate and sulphuric acid.
Once this reaction is completed (in about four hours), the solution
is made basic using a suitable base such as lye. The methcathinone
is then extracted from the basic solution using toluene which has
previously been dried using Epsom salt. In the next step, hydrogen
chloride gas is bubbled through the organic solution to precipitate
out the l-methcathinone hydrochloride salt. Following removal of the
solvents, the l-methcathinone hydrochloride exists as a chunky
powder, white to off-white in colour. Recently, some clandestine
laboratory operators, as a final step, have started washing the
methcathinone hydrochloride powder with acetone in order to further
remove impurities to make the powder more white in colour. As the
hydrochloride salt form, l-methcathinone is very stable and readily
water-soluble. To date almost all of the ephedrine used in
clandestine laboratories has come from the 25-milligram l-ephedrine
tablets purchased from pharmaceutical warehouses. Sodium dichromate
is readily obtained from most chemical supply stores. The sulphuric
acid is primarily obtained as battery acid from automotive stores.
Lye, toluene, acetone and muriatic acid (a solution of hydrochloric
acid) are obtained form hardware stores. The synthesis of l-
methcathinone hydrochloride does not require any special reaction
conditions or laboratory equipment. Laboratory equipment typically
consists of mason jars, funnels, coffee filters, tubing and a
stirring apparatus.
Methcathinone has been encountered by law enforcement officials
in Illinois, Indiana, Michigan, Missouri, North Carolina, Washington
and Wisconsin. Michigan State Police obtained the first street
sample of methcathinone in February 1991. Since that time, there
have been over 75 encounters of methcathinone by federal, state and
local law enforcement officials in Michigan. Methcathinone was first
encountered in Wisconsin in March 1992. Since October 1992, there
have been more than 30 federal, state or local law enforcement
encounters of methcathinone in Wisconsin. A number of encounters
have occurred in Indiana and Missouri. Isolated encouters have been
documented in Washington, North Carolina and Illinois.
The abuse and illicit trafficking of methcathinone has also been
reported in several other countries. In the Report of the
International Narcotics Control Board for 1992\2\, some States of
the Commonwealth of Independent States (CIS) are mentioned as
locations of methcathinone production from ephedrine principally
extracted from pharmaceutical preparations. The report also noted
that in some central Asian States such as Kyrgyzstan, ephedrine for
making methcathinone is extracted from the wild-growing Ephedra
species. In a 1992 report of the United Nations International Drug
Control Programme on a fact-finding mission to some of the CIS
States, methcathinone abuse was reported in Kazakhstan, Kyrgyzstan
and the Russian Federation. In the report, it was noted that in
Kyrgyzstan the abuse of methcathinone was spreading, and that 21
illicit laboratories for the conversion of ephedrine into
methcathinone had been detected. Ephedrine derived from Ephedra was
mentioned as being used to make methcathinone in Kazakhstan. In a
report on a separate mission to the Baltic States in 1992,
methcathinone was specifically mentioned as a drug of abuse in
Latvia. In addition, ``ephedrine-based'' drugs (believed to be
methcathinone) were identified as an abuse problem in Estonia and
Lithuania.
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\2\United Nations publication, Sales No. E. 93.XI.1.
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Some information is available on the production and abuse of
methcathinone, known as ephedrone, in the Russian Federation.
According to a report of the Ministry of the Interior All-Union
Scientific Research Institute of the former USSR, ephedrone surfaced
for the first time at Leningrad in 1982. Subsequently, ephedrone
abuse increased substantially among drug addicts who referred to
ephedrone under such street names as ``Jeff'', ``Joe Cocktail'',
``Mul'ka'', ``Cosmos'', ``Effendi'' and ``Pomimutka''. In the
Russian Federation, ephedrone is usually made by the oxidation of
ephedrine obtained primarily from medicinal preparations and, less
often, form the Ephedra plant. Ephedrine is oxidized by potassium
permanganate (not sodium dichromate) in the presence of acetic acid
(vinegar) and at temperatures of 50 to 60 degrees centigrade. No
attempt is made to isolate the ephedrone in pure form. Instead, the
entire solution, containing ephedrine, potassium permanganate and
acetic acid, is intravenously injected.
In the Russia Federation, ephedrone abuse is mostly found among
young people having a history of stimulant or opiate abuse.
Intravenous injection is the primary route of administration. As in
the United States, the principal pattern of abuse is the binge
lasting two to seven days. During a binge, ephedrone is repeatedly
injected starting out at doses of 2 to 3 millilitres and escalating
to 5 or 10 millilitres at a time. The interval between injections
are in the range of 30 minutes to 2 hours. During the binge, daily
cumulative doses may reach 100 to 150 millilitres of injectable
ephedrone solution. The binge is further characterized by lack of
food intake and ultimately by physical and mental exhaustion. The
binge is followed by a withdrawal period characterized by prolonged
periods of sleep, irritability, hot-tempered fits, weakness, general
psychic discomfort, suppression of mood and depression.
Ephedrone injection results in a ``high'' lasting 15 to 20
minutes followed by euphoria and a ``craving for activity'',
feelings of lightness, cheerfulness, fresh surges of energy,
``clearness of the head'' and improved mood. Somatic symtoms
observed following injection include accelerated heart rate,
increased arterial pressure, dilated pupils, nystagmus and pain of
the supraorbital points. Prolonged use of ephedrone is associated
with the appearance of psychotic states. Paranoia is commonly
observed. Both auditory and visual hallucinations may also be
experienced.
Examination of ephedrone drug addicts in the Russian Federation
have revealed the following characteristics: drastic weight loss;
acne vulgaris in the face, back, chest, shoulders, forearms and
feet; ``paths'' of pigmentation with sclerosal veins; acrocyanosis;
swelling of the hands; a waxen complexion; red tongue; and enlarged
liver. Often addicts have potassium manganate burns on their
fingers. Addicts tend not to pay attention to their appearance, thus
looking ragged with dirty hands and hair. Neurological examination
of ephedrone addicts reveal lateral nystagmus, increased tendon
periosteal reflexes, staggering in Romberg's posture and a fine
tremor of the fingers of extended hands.
ANNEX III
Questionnaire for data collection for use by the World Health
Organization and the Commission on Narcotic Drugs of the Economic
and Social Council
Substance reported on: METHCATHINONE
1. Availability of the substance (registered, marketed,
dispensed, etc.).
2. Extent of abuse of the substance.
3. Degree of seriousness of the public health and social
problems */ associated with abuse of the substance.
4. Number of seizures of the substance in the illicit traffic
during the previous three years and the quantities involved.
5. Identification of the seized substance as of local or foreign
manufacture and indication of any commercial markings.
6. Existence of clandestine laboratories manufacturing the
substance.
*/ Examples of public health and social problems are acute
intoxication, accidents, work absenteeism, mortality, behaviour
problems, criminality, etc.
B. WHO Questionnaire on Substances Under Review
Who Questionnaire for Collection of Information for Review of
Dependence-Producing Psychoactive Substances
The Director-General of the World Health Organization presents
his compliments and has the pleasure of informing Member States that
the Twenty-ninth Expert Committee on Drug Dependence (ECDD) will
meet on 26-29 September 1994 to review the following substances:
1. Aminorex
2. Brotizolam
3. Etryptamine (-ethyltryptamine)
4. Flunitrazepam
5. Mesocarb (sydnocarb)*
6. Methcathinone (ephedrone)
7. Triazolam*
8. Zipeprol
* Tentatively included in accordance with the recommendations of
the 28th ECDD (28 September-2 October 1992).
According to the ``Revised Guidelines for the WHO Review of
Dependence-Producing Psychoactive Substances for International
Control'', as approved by the eighty-fifth session of the Executive
Board (1990) and amended by the ninety-third session of the
Executive Board (1994), one of the essential elements of this
process is for WHO to collect and review information, and
subsequently to prepare a Critical Review document for submission to
the Expert Committee on Drug Dependence.
The Director-General invites Member States to collaborate as in
the past in this process by providing all pertinent information
available. In particular he would appreciate receiving any such
information under the six headings mentioned in the attached
questionnaire.\1\ A separate questionnaire form should be filled in
for each individual substance.
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\1\For Ministries of Health only.
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Further clarification on any of the above items can be obtained
from the Programme on Substance Abuse (PSA-WHO/HQ), Geneva, to which
replies should be sent not later than 15 June 1994.
GENEVA, 10 March 1994
II. Background
Aminorex and methcathinone are stimulants that are controlled
domestically in Schedule I of the CSA. Neither substance has been
approved for use in the treatment of any medical condition in this
country and neither substance is controlled internationally.
Etryptamine is currently controlled in Schedule I domestically, under
the temporary scheduling provisions of the CSA. Etryptamine has not
been approved for medical use in the United States.
Triazolam and flunitrazepam are controlled domestically and
internationally in Schedule IV of the CSA and the Convention. Triazolam
is approved for medical use in the United States, flunitrazepam is not.
Brotizolam, mesocarb, and zipeprol are not controlled domestically
or internationally, nor approved for use in the United States.
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 HHS invites interested persons to
submit data or comments regarding the eight named drugs. Data and
information received in response to this notice will be used to prepare
scientific and medical information on these drugs, with a particular
focus on each drug's abuse liability. HHS will forward that information
to WHO, through the Secretary of State, for WHO's consideration in
deciding whether to recommend international control 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.
At this time, HHS will not make any recommendations to WHO
regarding whether any of these drugs should be subjected to
international controls. Instead, HHS will defer such consideration
until WHO has made official recommendations to the Commission on
Narcotic Drugs, which are expected to be made in late 1994 or early
1995. Any HHS position regarding international control of these drugs
will be preceded by another Federal Register notice soliciting public
comment as required by section 201(d)(2)(B) of the CSA.
Interested persons may, on or before July 20, 1994, submit to the
Docket Management Branch (address above) written comments regarding
this notice. Two copies of any comments are to be submitted, except
that individuals may submit one copy. Comments should be identified
with the docket number found in brackets in the heading of this
document. Received comments may be seen in the office above between 9
a.m. and 4 p.m, Monday through Friday.
This abbreviated acceptance period is necessary to allow sufficient
time to prepare and submit the domestic information package by the
deadline imposed by WHO. Although WHO has requested comments and
information by June 15, 1994, WHO will accept and consider material
transmitted after June 15, 1994. Respondents should submit material in
the format set forth by the WHO Questionnaire.
This notice contains information collection requirements that were
submitted for review and approval to the Director of the Office of
Management and Budget (OMB), as required by section 3504(h) of the
Paperwork Reduction Act of 1980. The requirements were approved and
assigned OMB control number 0910-0226.
Dated: June 15, 1994.
William K. Hubbard,
Acting Deputy Commissioner for Policy.
[FR Doc. 94-14962 Filed 6-15-94; 3:28 pm]
BILLING CODE 4160-01-F