94-14962. International Drug Scheduling; Convention on Psychotropic Substances; Certain Stimulant/Hallucinogenic Drugs and Certain Nonbarbiturate Sedative Drugs  

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    [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
    
    
    

Document Information

Published:
06/20/1994
Department:
Health and Human Services Department
Entry Type:
Uncategorized Document
Action:
Notice.
Document Number:
94-14962
Dates:
Comments by July 20, 1994.
Pages:
0-0 (1 pages)
Docket Numbers:
Federal Register: June 20, 1994, Docket No. 94N-0173