Federal Register / Vol. 66, No. 43 / Monday, March 5, 2001 / Notices
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`13323
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`I. Background
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`publication of this document in the
`Federal Register. Therefore, a comment
`is best assured of having its full effect
`if OMB receives it within 30 days of
`publication. Written comments and
`recommendations for the proposed
`information collection should be sent
`directly to the following: Office of
`Management and Budget, Paperwork
`Reduction Project, 725 17th Street, NW.,
`Washington, DC 20503, Attn: Desk
`Officer for ACF.
`
`Dated: February 27, 2001.
`Bob Sargis,
`Reports Clearance Officer.
`[FR Doc. 01–5234 Filed 3–2–01; 8:45 am]
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`HHS.
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`Dated: February 23, 2001.
`William K. Hubbard,
`Senior Associate Commissioner for Policy,
`Planning, and Legislation.
`[FR Doc. 01–5158 Filed 3–2–01; 8:45 am]
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`HHS.
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`The United States is a party to the
`1971 Convention on Psychotropic
`Substances (the Convention). Section
`201(d)(2)(B) of the Controlled
`Substances Act (the CSA) (21 U.S.C.
`811(d)(2)(B)) provides that when the
`United States is notified under Article 2
`of the Convention that CND proposes to
`decide whether to add a drug or other
`substance to one of the schedules of the
`Convention, transfer a drug or substance
`from one schedule to another, or delete
`it from the schedules, the Secretary of
`State must transmit notice of such
`information to the Secretary of Health
`and Human Services (HHS). The
`Secretary of HHS must then publish a
`summary of such information in the
`Federal Register and provide
`opportunity for interested persons to
`submit comments. The Secretary of HHS
`must then evaluate the proposal and
`furnish a recommendation to the
`Secretary of State that shall be binding
`on the representative of the United
`States in discussions and negotiations
`relating to the proposal.
`As detailed below, the Secretary of
`State has received notification from the
`Secretary-General of the United Nations
`(the Secretary-General) regarding
`substances to be considered for control
`under the Convention. The notification
`reflects the recommendations from the
`31st WHO Expert Committee for Drug
`Dependence (ECDD), which met in June
`1998. In the Federal Register of April
`28, 2000 (65 FR 24969), FDA announced
`the WHO ECDD review, and the agency
`invited interested persons to submit
`information for WHO’s consideration.
`The full text of the notification from
`the Secretary-General is provided in
`section II of this document. Section
`201(d)(2)(B) of the CSA requires the
`Secretary of HHS, after receiving a
`notification proposing scheduling, to
`publish a notice in the Federal Register
`to provide the opportunity for interested
`persons to submit information and
`comments on the proposed scheduling
`action.
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`II. United Nations Notification
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`Administration (FDA) is providing
`interested persons with the opportunity
`to submit written comments concerning
`recommendations by the World Health
`Organization (WHO) to impose
`international manufacturing and
`distribution restrictions, under
`international treaties, on certain drug
`substances. The comments received in
`response to this notice will be
`considered in preparing the U.S.
`position on these proposals for a
`meeting of the United Nations
`Commission on Narcotic Drugs (CND) in
`Vienna, Austria, March 20 to 29, 2001.
`This notice is issued under the
`Controlled Substances Act.
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`March 15, 2001.
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`to the Dockets Management Branch
`(HFA–305), Food and Drug
`Administration, 5630 Fishers Lane, rm.
`1061, Rockville, MD 20852. To ensure
`expeditious review of written
`comments, send a copy by facsimile or
`e-mail to: James R. Hunter (address
`below).
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`Administration (FDA) is announcing
`that a collection of information entitled
`‘‘Infant Formula Requirements’’ has
`been approved by the Office of
`Management and Budget (OMB) under
`the Paperwork Reduction Act of 1995.
`
`Peggy Schlosburg, Office of Information
`Resources Management (HFA–250),
`Food and Drug Administration, 5600
`Fishers Lane, Rockville, MD 20857,
`301–827–1223.
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`I Food and Drug Administration,
`I Notice.
`I The Food and Drug
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`I Submit written comments by
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`I Food and Drug Administration,
`I Notice.
`I The Food and Drug
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`I In the
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`E
`
`Federal Register of November 9, 2000
`(65 FR 67388), the agency announced
`that the proposed information collection
`had been submitted to OMB for review
`and clearance under 44 U.S.C. 3507. An
`agency may not conduct or sponsor, and
`a person is not required to respond to,
`a collection of information unless it
`displays a currently valid OMB control
`number. OMB has now approved the
`information collection and has assigned
`OMB control number 0910–0256. The
`approval expires on February 29, 2004.
`A copy of the supporting statement for
`this information collection is available
`on the Internet at http://www.fda.gov/
`ohrms/dockets.
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`James R. Hunter, Controlled Substances
`Staff (HFD–9), Food and Drug
`Administration, 5600 Fishers Lane,
`Rockville, MD 20857, 301–827–2098,
`Fax: 301–443–9222, e-mail:
`hunterj@cder.fda.gov.
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`The formal United Nations
`notification that identifies the drug
`substances and explains the basis for the
`recommendations is reproduced below.
`Notification on 2C-B, 4-MTA, GHB
`and Zolpidem: Reference: NAR/CL.26/
`2000 CU 2000/240.
`C1971/WHO
`UNDCP 42nd CND
`TLACSB/CNDS–40/00
`The Secretary-General of the United
`Nations presents his compliments to the
`Secretary of State of the United States of
`
`‡
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`Page 1 of 4
`
`JAZZ EXHIBIT 2049
`Amneal Pharms. et al. (Petitioners) v. Jazz Pharms., Inc. (Patent Owner)
`Case IPR2015-00554
`
`

`
`13324
`
`Federal Register / Vol. 66, No. 43 / Monday, March 5, 2001 / Notices
`
`America and has the honour to inform
`the Government that, pursuant to article
`2, paragraphs 1 and 4, of the Convention
`on Psychotropic Substances, 1971, he
`has received a notification from the
`World Health Organization (WHO)
`concerning proposed recommendations
`for international control in respect of
`the following four substances: 2C-B, 4-
`MTA, GHB and zolpidem.
`In accordance with the provisions of
`article 2, paragraph 2, of the 1971
`Convention, the Secretary-General is
`transmitting the text of that notification
`as an annex to the present note.
`As will be seen from the notification
`and the attached assessments and
`recommendations, WHO recommends
`that 2C-B be included in Schedule II, 4-
`MTA in Schedule I, and GHB and
`zolpidem in Schedule IV of that
`Convention.
`Article 2, paragraph 1, of the
`Convention reads:
`
`If a Party or the World Health Organization
`has information relating to a substance not
`yet under international control which in its
`opinion may require the addition of that
`substance to any of the Schedules of this
`Convention, it shall notify the Secretary-
`General and furnish him with the
`information in support of that notification.
`The foregoing procedure shall also apply
`when a Party or the World Health
`Organization has information justifying the
`transfer of a substance from one Schedule to
`another among those Schedules, or the
`deletion of a substance from the Schedules.
`
`Article 2, paragraph 4, reads:
`
`If the World Health Organization finds: (a)
`That the substance has the capacity to
`produce (i)(1) a state of dependence and (2)
`central nervous system stimulation or
`depression, resulting in hallucinations or
`disturbances in motor function or thinking or
`behaviour or perception or mood, or (ii)
`similar abuse and similar ill effects as a
`substance in Schedule I, II, III or IV, and (b)
`That there is sufficient evidence that the
`substance is being or is likely to be abused
`so as to constitute a public health and social
`problem warranting the placing of the
`substance under international control, the
`World Health Organization shall
`communicate to the Commission an
`assessment of the substance, including the
`extent or likelihood of abuse, the degree of
`seriousness of the public health and social
`problem and the degree of usefulness of the
`substance in medical therapy, together with
`recommendations on control measures, if
`any, that would be appropriate in the light
`of its assessment.
`
`Pursuant to article 2, paragraph 2, of
`the Convention, the notification,
`together with the assessments and
`recommendations from WHO as well as
`any data received from Governments on
`any of these substances, will be brought
`to the attention of the Commission on
`
`Narcotic Drugs at its forty-fourth session
`in March 2001. Any action or decision
`taken by the Commission with respect
`to that notification, pursuant to article 2,
`paragraph 5, of the Convention, will be
`notified to States Parties in due course.
`Article 2, paragraph 5, of the
`Convention reads:
`
`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 it if the Government would
`submit data on seizures of any of these
`substances or on the existence of
`clandestine laboratories manufacturing
`them. Such data would assist the
`Commission in its consideration of
`possible international control of some or
`all of the substances under review.
`In order to further assist the
`Commission in reaching a decision, it
`would be appreciated if any economic,
`social, legal, administrative or other
`factors the Government may consider
`relevant to the question of the possible
`scheduling of these four substances
`could be communicated by 12 December
`2000 to the Executive Director of the
`United Nations International Drug
`Control Programme, c/o Commission on
`Narcotic Drugs Secretariat Section, P.O.
`Box 500, A–1400 Vienna, Austria, fax:
`43–1–26060–5885.
`2 November 2000
`NAR/CL.26/2000
`
`Annex—Note Dated 4 October 2000
`Addressed to the Secretary-General by
`the Director-General of the World
`Health Organization
`
`The Director-General of the World
`Health Organization presents her
`compliments to the Secretary-General of
`the United Nations and has the honour
`to submit, in accordance with Article 2,
`paragraphs 1 and 4, of the Convention
`on Psychotropic Substances, 1971,
`assessments and recommendations of
`the World Health Organization, as set
`forth on the annex hereto, concerning
`the proposed international control in
`respect of 2C-B, 4-MTA, GHB, and
`zolpidem.
`The Director-General of the World
`Health Organization avails herself of
`this opportunity to renew to the
`Secretary-General of the United Nations
`the assurances of her highest
`consideration.
`
`2C-B (4-Bromo-2,5-
`dimethoxyphenylethylamine) Substance
`identification
`2C-B is chemically 4-bromo-2,5-
`dimethoxyphenylethylamine; 2-(4-
`bromo-2,5-dimethoxyphenyl)
`ethylamine (CAS 66142–81–2). Other
`names include: α-desmethyl DOB;
`BDMPEA; MFT; Erox; Nexus;
`Performax. There are no chiral centres;
`therefore, no stereoisomers or racemates
`are possible.
`
`Similarity to Known Substances and
`Effects on the Central Nervous System
`2C-B has structural and
`pharmacological similarities to
`brolamfetamine and mescaline. 2C–B is
`
`a selective partial agonist for 5-HT
`and 5-HT
`’ -serotonin receptors. In
`
`humans, 2C–B is more potent than
`mescaline but less potent than
`brolamfetamine. In low doses it has
`sensory enhancing effects: skin
`sensitivity, heightened responsiveness
`to smells, tastes and sexual stimulation.
`In higher doses 2C-B is a strong
`hallucinogen. 2C-B produces
`particularly marked visual
`hallucinations with an intense colour
`play, intriguing patterns emerging on
`surfaces and distortions of objects and
`faces. It was reported to enhance sexual
`feelings, sexual perception and
`performance.
`
`‘ -
`
`Dependence Potential
`There are no animal or human studies
`about the dependence potential of 2C-B.
`
`Actual Abuse and/or Evidence of
`Likelihood of Abuse
`In the 1990s, 2C-B was sold as an
`aphrodisiac in several countries and
`some abuse of 2C-B has been reported
`by a number of countries. These suggest
`that 2C-B has modest abuse liability like
`other hallucinogens. Although
`hallucinogens are rarely associated with
`compulsive use or dependent use, they
`are known to have modest abuse
`potential, particularly in polydrug
`abusers.
`
`Therapeutic Usefulness
`Apart from the controversial
`experimental use to facilitate
`psychotherapy, hallucinogens, such as
`2C-B, do not have any therapeutic
`usefulness.
`
`Recommendation
`Despite the limited availability of
`studies, the chemical and
`pharmacological similarity of 2C-B to
`the hallucinogen mescaline has been
`demonstrated. The altered state of mind
`induced by hallucinogens such as 2C-B
`may result in harm to the user and to
`
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`

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`Federal Register / Vol. 66, No. 43 / Monday, March 5, 2001 / Notices
`
`13325
`
`others. Based on its perceived
`aphrodisiac effects and known modest
`abuse potential of hallucinogenic drugs
`in general, it is estimated that 2C-B may
`be abused so as to constitute a public
`health and social problem warranting its
`placement under international control.
`However, hallucinogens are rarely
`associated with compulsive use and
`abuse of 2C-B has been infrequent,
`suggesting that abuse of 2C–B is likely
`to constitute a substantial, rather than
`an especially serious, risk to public
`health. On these bases, it is
`recommended that 2C-B be placed in
`Schedule II of the 1971 Convention on
`Psychotropic Substances.
`
`4-MTA (4-methylthioamphetamine)
`Substance Identification
`
`4-MTA is chemically 4-
`methylthioamphetamine (CAS 14116–
`06–4) Other names include: α-methyl 4-
`methylthiophenetylarnine, p-
`methylthioamphetamine; 4-MTA; p–
`
`One and Only Dominator. 4-MTA has
`one chiral centre and can exist in two
`enatiomers and a racemate. Only the
`racemic mixture has been reported to
`have been synthesised.
`
`Similarity to Known Substances and
`Effects on the Central Nervous System
`
`MTA; MTA; MK; S5; S“ ; Flatliner; The
`
`4-MTA is a potent serotonin-releasing
`agent and reversible inhibitor of
`monoamine oxidase-A, and is
`structurally similar to 4-
`methoxyamphetamine.
`Pharmacologically, it is similar to MDA
`and MDMA; studies suggest that 4-MTA
`is six times more potent than MDMA
`and MDA in inhibiting 5-HT uptake.
`
`Dependence Potential
`
`Drug discrimination studies in rats
`suggest that 4-MTA produces
`discriminative stimulus effects similar
`to MDMA. 4-MTA did not substitute for
`amphetamine, LSD or phencyclidine.
`Reports from the United Kingdom
`indicate that 4-MTA is abused for its
`stimulant/euphoric effects similar to
`MDMA.
`
`Actual Abuse and/or Evidence of
`Likelihood of Abuse
`
`4-MTA is mainly abused in Europe. It
`appears that 4-MTA is part of the dance
`music culture although its use is
`relatively less widespread probably
`because of perceptions by users that the
`drug is stronger and more harmful than
`other ‘‘club drugs’’ such as MDMA. 4-
`MTA has resulted in a number of
`fatalities and hospital admissions. It
`appears that toxic effects can be
`produced directly from the drug and
`
`that the presence of other drugs or
`alcohol may exacerbate such effects.
`
`Therapeutic Usefulness
`4-MTA has no recognized therapeutic
`use.
`
`Recommendation
`4-MTA is chemically and
`pharmacologically similar to MDA and
`MDMA. 4-MTA is a new synthetic drug
`which was seized for the first time in
`1997. Although evidence of its actual
`abuse is available only in several
`countries in Europe, seizures, including
`those of large quantities reported from a
`wider range of countries, suggest that
`the trafficking and abuse of 4-MTA are
`more widespread than have been
`reported. Based on this and its
`similarity to known MDA-type
`psychotropic substances, as well as data
`from drug discrimination studies in
`animals, it is estimated that 4-MTA is
`likely to be abused so as to constitute a
`public health and social problem
`warranting its placement under
`international control. Taking into
`consideration that 4-MTA has no
`recognized therapeutic use and that it
`has resulted in a number of fatalities,
`abuse of 4-MTA is estimated to
`constitute an especially serious risk to
`public health. It is therefore
`recommended that 4-MTA be placed in
`Schedule I of the 1971 Convention on
`Psychotropic Substance.
`
`GHB (Gamma-hydroxybutyric acid)
`Substance Identification
`GHB is chemically γ-hydroxybutyric
`acid; 4-hydroxybutyric acid (CAS 591–
`81–1). GHB usually exists as either the
`free acid or as the sodium salt. Sodium
`oxybate (CAS 502–85–2) is a national
`nonproprietary name for its sodium salt.
`There are no chiral centres; therefore, no
`stereoisomers or racemates are possible.
`
`Similarity to Known Substances and
`Effects on the Central Nervous System
`GHB is an endogenous compound and
`is structurally similar to the
`neurotransmitter GABA.
`Pharmacologically, it produces sedative
`and anaesthetic effects at high doses.
`Such depressant effects of GHB appear
`to be associated with its cataleptic
`effects and are different from those of
`barbiturates and benzodiazepines. GHB
`sedation possessed distinct excitatory
`properties, which may be due to its
`effect on the dopaminergic system
`(increase in intracellular neuronal
`dopamine). GHB has been found to
`induce anesthesia (but does not provide
`pain relief), (slow-wave) sleep,
`bradycardia, vomiting, random clonic
`movements, hypothermia, reduction in
`
`potassium levels, decrease in ventilatory
`rate and apnoea. However, the
`respiratory centre remains sensitive to
`an increase in carbon dioxide.
`
`Dependence Potential
`
`In drug discrimination studies in
`animals, none of the known abused
`drugs has the ability to fully substitute
`for GHB. Morphine, dexamphetamine,
`LSD and some benzodiazepines
`produced, at best, partial substitution.
`There have been few studies regarding
`the dependence/abuse potential of GHB.
`However, during the numerous studies
`involving administration of GHB to
`patients at varying concentrations, no
`dependence has been observed at low
`doses of GHB. At prolonged high doses,
`however, a withdrawal syndrome
`including insomnia, muscular
`cramping, tremor and anxiety has been
`noted upon discontinuation in some
`cases.
`
`Actual Abuse and/or Evidence of
`Likelihood of Abuse
`
`GHB abuse has been reported in
`Australia, USA and many countries in
`Europe. Precursors of GHB, such as γ-
`butyrolaztone and 1,4-butanediol,
`which are metabolized to GHB in the
`body, have also been abused. Although
`initially abused by body-builders for its
`apparent growth hormone promoting
`properties, the more recent primary
`mode of abuse worldwide has been the
`use of GHB for its subjective hypnotic,
`euphoric and hallucinogenic effects,
`especially in the context of the dance
`music culture (i.e. ‘‘raves’’). Some users
`have also claimed to use GHB as an
`alternative to alcohol (for relaxation), as
`a sexual adjunct, appetite suppressant,
`anti-aging product and has also been
`implicated in cases of sexual assault.
`It appears that toxic effects can be
`produced directly from the drug and the
`presence of other depressant or sedative
`drugs (e.g. opiates, benzodiazepines,
`alcohol and barbiturates) and possibly
`other psychoactive compounds (e.g.
`amphetamine) may exacerbate the
`effects of GHB. Hospital admissions and
`deaths have been linked to GHB
`ingestion and generally involve the
`onset of coma and respiratory
`depression.
`
`Therapeutic Usefulness
`
`GHB has been used as an anaesthetic
`agent and as an aid to alcohol/opiate
`withdrawal, primarily in France,
`Germany and Italy, respectively. In USA
`and Canada it is currently under
`evaluation for the treatment of
`narcolepsy-associated cataplexy.
`
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`Page 3 of 4
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`

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`13326
`
`Federal Register / Vol. 66, No. 43 / Monday, March 5, 2001 / Notices
`
`Recommendation
`Although GHB is an endogenous
`compound that exists in the human
`body, GHB has psychoactive and toxic
`effects when administered. The pattern
`and consequences of its abuse in a
`number of countries in Europe and the
`USA seem to suggest that its liability to
`abuse constitutes a significant risk to
`public health. The current easy
`availability of GHB and some of its
`precursors has contributed to its recent
`abuse. The wide availability is likely to
`be reduced once GHB is placed under
`international control. On these bases, it
`is recommended that GHB be placed in
`Schedule IV of the 1971 Convention on
`Psychotropic Substances.
`
`Zolpidem (INN) Substance
`Identification
`Zolpidem is chemically N,N,6-
`trimethyl-2-p-tolylimidazo [1,2-
`a]pyridine-3-acetamide; N,N,6-
`trimethyl-2-(4-
`methylphenyl)imidazo[1,2-a]pyridine-3-
`acetamide (CAS 82626–48–0). Trade
`names include: Ambien, Bikalm, Niotal,
`Stilnoct, Stilnox.
`
`Similarity to Known Substances and
`Effects on the Central Nervous System
`Though chemically different from
`benzodiazepines, zolpidem produces
`benzodiazepine-like effects. It acts as an
`agonist binding with high and low
`
`subtypes, respectively. It is generally
`believed to produce relatively greater
`hypnotic effects than other
`benzodiazepine-like effects.
`
`affinity to BZ” and BZ receptor
`
`Dependence Potential
`The results of human laboratory
`studies suggest that zolpidem and
`triazolam are generally similar in terms
`of producing subjective reinforcing
`effects. As with many of the
`benzodiazepines, there have been a
`number of case reports describing
`withdrawal symptoms after cessation of
`zolpidem administration. Though
`withdrawal discomfort does not
`necessarily lead to compulsory drug
`taking (drug dependence) in humans,
`there are reports of clinically diagnosed
`cases of drug dependence resulting from
`a prolonged use of zolpidem.
`
`Actual Abuse and/or Evidence of
`Likelihood of Abuse
`Epidemiological studies indicate that
`zolpidem is associated with relatively
`low incidence of abuse. Sporadic case
`reports in the scientific literature have
`indicated that zolpidem is abused, but
`these cases usually involved patients
`with histories of drug abuse or chronic
`psychiatric disorders. Cases of zolpidem
`
`overdose requiring emergency treatment
`have been reported. Death due to
`zolpidem overdose is rare. Rates of
`actual abuse and dependence of
`zolpidem appear to be similar to other
`hypnotic benzodiazepines in Schedule
`IV. In terms of the numbers of cases of
`abuse, dependence and withdrawal
`reported as adverse drug reactions to the
`WHO adverse drug reaction database,
`less than ten benzodiazepines are
`ranked higher than zolpidem.
`
`Therapeutic Usefulness
`Zolpidem is used for treatment of
`insomnia in more than 80 countries.
`
`Recommendation
`Although zolpidem has a somewhat
`novel neuropharmacological profile
`relative to classic benzodiazepines,
`studies of its abuse potential suggest
`that it may be comparable to that of
`many benzodiazepines. Furthermore,
`rates of actual abuse and dependence of
`zolpidem in medical use, as well as the
`risk to public health of its abuse, appear
`to be similar to hypnotic
`benzodiazepines presently placed in
`Schedule IV. On these bases, it is
`recommended that zolpidem be placed
`in Schedule IV of the 1971 Convention
`on Psychotropic Substances.
`
`I. Discussion
`Although WHO has made specific
`scheduling recommendations for each of
`the drug substances, the CND is not
`obliged to follow the WHO
`recommendations. Options available to
`the CND for substances considered for
`control under the Psychotropic
`Convention include: (1) Acceptance of
`the WHO recommendations; (2)
`acceptance of the recommendations to
`control, but control the drug substance
`in a schedule other than that
`recommended; or (3) rejection of the
`recommendations entirely.
`4-Bromo-2,5-
`dimethoxyphenethylamine (2C-B) is a
`Schedule I controlled substance in the
`United States. The U.S. Drug
`Enforcement Administration (DEA)
`placed 2C-B (including salts, isomers,
`and salts of isomers: isomers include
`optical, positional, and geometric) in
`Schedule I of the Controlled Substance
`Act (CSA) in June 1995. 4-
`methylthioamphetamine (4-MTA) is not
`marketed in the United States and is not
`currently a controlled substance in the
`United States. Gamma hydroxybutyric
`acid (GHB) is a Schedule I controlled
`substance in the United States. GHB,
`including its salts, optical isomers, and
`salts of optical isomers, became a
`Schedule I controlled substance in
`March 2000. Registered manufacturers
`
`
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`and distributors of GHB when it is
`manufactured, distributed, or possessed
`in accordance with an FDA authorized
`investigational new drug exemption
`under Section 505(i) of the Federal
`Food, Drug, and Cosmetic Act (21 USC
`355(i)) are subject to Schedule III
`security requirements. If FDA approves
`a drug product containing GHB for
`marketing, the approved product will be
`placed into Schedule III under Public
`Law 106–172. Zolpidem, its salts,
`isomers, and salts of isomers, is a
`Schedule IV controlled substance in the
`United States. The DEA placed
`zolpidem in Schedule IV in February
`1993. With the exception of 4-MTA,
`current controls in the United States on
`the substances under consideration for
`international control appear to meet the
`requirements of the recommended
`Psychotropic Convention schedules.
`
`IV. Comments
`Interested persons may, on or before
`March 15, 2001, submit to the Dockets
`Management Branch (address above)
`written comments regarding this notice.
`This abbreviated comment period is
`necessary to allow HHS to furnish a
`recommendation to the Secretary of
`State in time for the March 2001
`meeting of the United Nations
`Commission on Narcotic Drugs.
`Comments are to be identified with the
`docket number found in brackets in the
`heading of this document. Received
`comments may be seen in the Dockets
`Management Branch (address above)
`between 9 a.m. and 4 p.m., Monday
`through Friday.
`
`Dated: February 27, 2001.
`Ann M. Witt,
`Acting Associate Commissioner for Policy.
`[FR Doc. 01–5218 Filed 2–28–01; 11:36 am]
`
`HHS.
`
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`This notice announces a forthcoming
`meeting of a public advisory committee
`of the Food and Drug Administration
`(FDA). The meeting will be open to the
`public.
`Name of Committee: Blood Products
`Advisory Committee.
`General Function of the Committee:
`To provide advice and
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`Page 4 of 4