[Federal Register Volume 59, Number 117 (Monday, June 20, 1994)]
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From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 94-14962]


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[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