[Federal Register Volume 80, Number 17 (Tuesday, January 27, 2015)]
[Notices]
[Pages 4283-4288]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2015-01408]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2015-N-0045]


International Drug Scheduling; Convention on Psychotropic 
Substances; Single Convention on Narcotic Drugs; World Health 
Organization; Scheduling Recommendations; AH-7921; Gamma-Butyrolactone; 
1,4-Butanediol; Ketamine; 9 Additional Substances; Request for Comments

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice.

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SUMMARY: The Food and Drug Administration (FDA) is providing interested 
persons with the opportunity to submit written comments and to request 
an informal public meeting concerning recommendations by the World 
Health Organization (WHO) to impose international manufacturing and 
distributing restrictions, under international treaties, on certain 
drug substances. The comments received in response to this notice and/
or public meeting will be considered in preparing the United States 
position on these proposals for a meeting of the United Nations 
Commission on Narcotic Drugs (CND) in Vienna, Austria, in March 2015. 
This notice is issued under the Controlled Substances Act (the CSA).

DATES: Submit either electronic or written comments by February 26, 
2015. Submit requests for a public meeting on or before February 6, 
2015. (For additional information, see also section IV of this 
document).

ADDRESSES: Submit electronic comments to http://www.regulations.gov. 
Submit written comments to the Division of Dockets Management (HFA-
305), Food and Drug Administration, 5630 Fishers Lane, Rm. 1061, 
Rockville, MD 20852.

FOR FURTHER INFORMATION CONTACT: James R. Hunter, Center for Drug 
Evaluation and Research, Controlled Substance Staff, Food and Drug 
Administration, 10903 New Hampshire Ave., Bldg. 51, Rm. 5150, Silver 
Spring, MD 20993-0002, 301-796-3156, <a href="/cdn-cgi/l/email-protection#452f242820366b2d302b312037052321246b2d2d366b222a33"><span class="__cf_email__" data-cfemail="2248434f47510c4a574c564750624446430c4a4a510c454d54">[email protected]</span></a>.

SUPPLEMENTARY INFORMATION:

[[Page 4284]]

I. Background

    The United States is a party to the 1971 Convention on Psychotropic 
Substances (Psychotropic Convention). Section 201(d)(2)(B) of the CSA 
(21 U.S.C. 811(d)(2)(B)) provides that when the United States is 
notified under Article 2 of the Psychotropic Convention that the CND 
proposes to decide whether to add a drug or other substance to one of 
the schedules of the Psychotropic 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 (Secretary of 
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 in the following paragraphs, the Secretary of State has 
received notification from the Secretary-General of the United Nations 
(the Secretary-General) regarding 13 substances to be considered for 
control under the Psychotropic Convention. This notification reflects 
the recommendation from the 36th WHO Expert Committee for Drug 
Dependence (ECDD), which met in June 2014. In the Federal Register of 
December 30, 2013 (78 FR 79465), FDA announced the WHO ECDD review and 
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.
    The United States is also a party to the 1961 Single Convention on 
Narcotic Drugs (1961 Single Convention). The Secretary of State has 
received a notification from the Secretary-General regarding a 
substance to be considered for control under this convention. The CSA 
does not require HHS to publish a summary of such information in the 
Federal Register. Nevertheless, in an effort to provide interested and 
affected persons an opportunity to submit comments regarding the WHO 
recommendations for narcotic drugs, the notification regarding this 
substance is also included in this Federal Register notice. The 
comments will be shared with other relevant agencies to assist the 
Secretary of State in formulating the position of the United States on 
the control of this substance. The HHS recommendations are not binding 
on the representative of the United States in discussions and 
negotiations relating to the proposal regarding control of substances 
under the 1961 Single Convention.

II. United Nations Notification

    The formal notification from the United Nations that identifies the 
drug substances and explains the basis for the recommendations is 
reproduced as follows:

Reference:
NAR/CL.11/2014
WHO/ECDD36; 1961C-Art.3; 1971C-Art.2
CU 2014/288/DTA/SGB

    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 the 
Director-General of the World Health Organization (WHO), pursuant to 
article 3, paragraphs 1 and 3 of the Single Convention on Narcotic 
Drugs of 1961 as amended by the 1972 Protocol (1961 Convention) and 
article 2, paragraphs 1and 4 of the Convention on Psychotropic 
Substances of 1971 (1971 Convention) notified the Secretary-General 
of the following recommendations:

AH-7921 be placed in Schedule I of the 1961 Convention
and
Gamma-butyrolactone (GBL)
1,4-butanediol
25B-NBOMe (2C-B-NBOMe)
25C-NBOMe (2C-C-NBOMe)
25I-NBOMe (2C-I-NBOMe)
be placed in Schedule I of the 1971 Convention
and
N-benzylpiperazine (BZP)
JWH-018
AM-2201
3,4-methylenedioxypyrovalerone (MDPV)
Methylone (beta-keto-MDMA)
Mephedrone
be placed in Schedule II of the 1971 Convention.

    In accordance with the provisions of article 3, paragraph 2 of 
the 1961 Convention and article 2, paragraph 2 of the 1971 
Convention, the Secretary-General hereby transmits the notification 
as annex I to the present note. Also in accordance with the same 
provisions, the notification from WHO will be brought to the 
attention of the fifty-eighth session of the Commission on Narcotic 
Drugs, 9-17 March 2015.

His Excellency
Mr. John Kerry
Secretary of State of the United States of America

    In connection with the notification, WHO has also submitted the 
relevant extract from the report of the thirty-sixth session of the 
WHO Expert Committee on Drug Dependence which is hereby transmitted 
as annex II.
    Reference is made to the notification concerning the proposed 
recommendation for international control of mephedrone (4-
methylmethcathinone) by the Government of the United Kingdom of 
Great Britain and Northern Ireland and to the respective note NAR/
CL.2/2014 of 7 February 2014 of the Secretary-General to all Member 
States.
    Furthermore reference is made to the notification concerning the 
proposed recommendation for international control of ketamine by the 
Government of the People's Republic of China and to the respective 
note NAR/CL.4/2014 of 14 March 2014 by the Secretary-General to all 
Member States, as well as to the recommendation of the Expert 
Committee on Drug Dependence related to ketamine (see annex I, page 
2).
    In order to assist the Commission in reaching a decision, it 
would be appreciated if the Government could communicate any 
economic, social, legal, administrative or other factors that it 
considers relevant to the possible scheduling of the afore-mentioned 
substances under the 1961 Convention and the 1971 Convention, at the 
latest by 30 January 2015 to the Executive Director of the United 
Nations Office on Drugs and Crime, c/o Secretary, Commission on 
Narcotic Drugs, P.O. Box 500, 1400 Vienna, Austria, fax: +43-1-
26060-5885, email: <a href="/cdn-cgi/l/email-protection#8ffce8edcffae1e0ebeca1e0fde8"><span class="__cf_email__" data-cfemail="582b3f3a182d36373c3b76372a3f">[email protected]</span></a>.

17 December 2014
NAR/CL.11/2014
Annex I

Annex I

Letter Addressed to the Secretary-General of the United Nations 
From the Director-General of the World Health Organization

    ``With reference to Article 2, paragraphs 1, 4 and 6 of the 
Convention on Psychotropic Substances (1971) and Article 3, 
paragraphs 1, 3 and 5 of the Single Convention on Narcotic Drugs 
(1961), as amended by the 1972 Protocol, and following the 36th 
meeting of the Expert Committee on Drug Dependence in June 2014, I 
am pleased to submit recommendations of the World Health 
Organization.

    The recommendations are that:

--AH-7921, be placed in Schedule I of the Single Convention on 
Narcotic Drugs (1961), that:
--Gamma-butyrolactone (GBL); 1,4-butanediol; 25B-NBOMe (2C-B-NBOMe); 
25C-NBOMe (2C-C-NBOMe) and 25I-NBOMe (2C-I-NBOMe), be placed in 
Schedule I of the Convention on Psychotropic Substances (1971) and 
that:
--N-benzylpiperazine (BZP); JWH-018; AM-2201; 3,4-
methylenedioxypyrovalerone (MDPV); Methylone (beta-keto-MDMA); 
Mephedrone, be placed in Schedule II of the Convention on 
Psychotropic Substances (1971).

    The recommendations and the assessments and findings on which 
they are based are set out in detail in the Report of the 36th 
Expert Committee on Drug Dependence, which is

[[Page 4285]]

the Committee that advises me on these issues. An extract of the 
Committee's Report is attached in Annex 1 to this letter.
    A notification has been made by the United Kingdom of Great 
Britain and Northern Ireland, pursuant to article 2, paragraphs 1 
and 3 of the Convention on Psychotropic Substances, 1971 concerning 
a proposed recommendation for international control of mephedrone. 
The Expert Committee critically reviewed this substance and 
considered that the degree of risk to public health and society 
associated with the abuse liability of mephedrone is substantial and 
therefore considered that the evidence of its abuse warranted its 
placement under international control, in Schedule II of the 
Convention on Psychotropic Substances (1971).
    Following a notification under Article 2, paragraph 1 of the 
Convention on Psychotropic Substances (1971) by the Government of 
the People's Republic of China concerning proposed recommendation 
for international control of ketamine, the Expert Committee 
critically reviewed this substance, following its previous critical 
reviews of ketamine at its 35th and 34th meeting and the pre-review 
undertaken at its 33rd meeting. The information provided by China 
with its notification to the Secretary-General was brought to the 
Expert Committee's attention. The Expert Committee's assessment was 
that ketamine ``is widely used as an anaesthetic in human and 
veterinary medicine, and is included in the WHO Model List of 
Essential Medicines and the WHO Model List of Essential Medicines 
for Children as well as in many national lists of essential 
medicines''. The Expert Committee found that it was presented with 
``compelling evidence [. . .] about the prominent place of ketamine 
as an anaesthetic in developing countries and crisis situations''. 
While the Expert Committee ``acknowledged the concerns raised by 
some countries and UN organizations'', it stated that ``ketamine 
abuse currently does not appear to pose a sufficient public-health 
risk of global scale to warrant scheduling'' and recommended ``that 
ketamine not be placed under international control at this time''. 
``Countries with serious abuse problems may decide to introduce or 
maintain control measures, but should ensure ready access to 
ketamine for surgery and anaesthesia for human and veterinary 
care''.
    During its meeting, the Expert Committee also discussed the 
importance of having reliable and sufficient data that could inform 
the review process in particular for New Psychoactive Substances 
(NPS), acknowledging the fact that more and more NPS will likely be 
reviewed in the future, for which data will not always be readily 
available. UNODC and WHO will hold an international experts 
consultation in December 2014 to identify selection criteria for 
prioritisation of NPS to be reviewed by the Committee as well as 
relevant indicators, methods and tools for data collection on NPS.
    I am very pleased with the ongoing collaboration between WHO, 
UNODC and INCB for improving access to controlled medicines while 
preventing misuse and trafficking and for preparing the Special 
Session of the United Nations General Assembly on the World Drug 
Problem in 2016.''

NAR/CL.11/2014
Annex II

Annex II

Extract From the Report of the 36th Expert Committee on Drug Dependence

    Substance recommended to be scheduled in Schedule I of the 
Single Convention on Narcotic Drugs (1961), as amended by the 1972 
Protocol:

AH-7921

    AH-7921 is an N-substituted cyclohexylmethylbenzamide and is 
chemically 3,4-dichloro-N-{[1-
(dimethylamino)cyclohexyl]methyl{time} benzamide.
    AH-7921 had not been previously pre-reviewed or critically 
reviewed. A direct critical review was proposed based on information 
brought to WHO's attention that AH-7921 is clandestinely 
manufactured, of especially serious risk to public health and 
society, and of no recognized therapeutic use by any party. 
Preliminary data collected from literature and different countries 
indicated that this substance may cause substantial harm and that it 
has no medical use.
    AH-7921 is an opioid with ``morphine-like'' effects. The 
Committee considered that the degree of risk to public health and 
society associated with the abuse liability and accompanying 
evidence warranted its placement under international control. The 
Committee recommended that AH-7921 be placed in Schedule I of the 
Single Convention on Narcotic Drugs (1961), as amended by the 1972 
Protocol.
    Substances recommended to be scheduled in Schedule I of the 
Convention on Psychotropic Substances (1971):

Gamma-butyrolactone (GBL)
Gamma-butyrolactone (GBL) is chemically oxolan-2-one. GBL can be 
synthesised from gamma-hydroxybutyric acid (GHB) or tetrahydrofuran.

    During the discussion of GHB at the 34th Meeting of the WHO 
Expert Committee on Drug Dependence (ECDD), the Committee ``noted 
information relating to the abuse of GBL itself (convertible to GHB 
in the body) and suggested this substance for pre-review''. Based on 
the evidence presented in the pre-review of GBL during its 35th 
Meeting, given its close association with GHB, and the 
recommendation made by the Committee to reschedule GHB from Schedule 
IV to Schedule II of the Convention on Psychotropic Substances 
(1971), the Committee recommended that a critical review of GBL be 
undertaken.
    The Committee considered that the degree of risk to public 
health and society associated with the abuse liability of GBL is 
especially serious. Whilst the Committee recognized widespread and 
important industrial use, it has no defined therapeutic usefulness. 
The Committee considered that the evidence of its abuse warranted 
its placement under international control within Schedule I of the 
Convention on Psychotropic Substances (1971).

1,4-butanediol
1,4-butanediol (butane-1,4-diol, 1,4-BDO or 1,4-BD) is one of four 
stable isomers of butanediol.

    During the discussion of gamma-hydroxybutyric acid (GHB) at its 
34th Meeting, the Committee ``noted information relating to the 
abuse of 1,4-BD itself (convertible to GHB in the body) and 
suggested this substance for pre-review''. Based on the evidence 
presented in the pre-review of GBL during its 35th Meeting, given 
its close association with GHB, and the recommendation made by the 
Committee to reschedule GHB from Schedule IV to Schedule II of the 
Convention on Psychotropic Substances (1971), the Committee 
recommended that a critical review of 1,4-BD be undertaken.
    1,4-butanediol produces its effects in the body through the in 
vivo formation of the scheduled substance GHB. The Committee 
considered that the degree of risk to public health and society 
associated with the abuse liability of 1,4-butanediol is especially 
serious. Whilst the Committee recognized widespread and important 
industrial use, it has no defined therapeutic usefulness. The 
Committee considered that the evidence of its abuse warranted its 
placement under international control within Schedule I of the 
Convention on Psychotropic Substances (1971).

25B-NBOMe
25B-NBOMe (2C-B-NBOMe) is chemically 2-(4-bromo-2,5-
dimethoxyphenyl)-N-[(2-methoxyphenyl)methyl]ethanamine.

    25B-NBOMe had not been previously pre-reviewed or critically 
reviewed. A direct critical review was proposed based on information 
brought to WHO's attention that 25B-NBOMe is clandestinely 
manufactured, of especially serious risk to public health and 
society, and of no recognized therapeutic use by any party. 
Preliminary data collected from literature and different countries 
indicated that this substance may cause substantial harm and that it 
has no medical use.
    The Committee noted the challenges associated with the evidence 
base concerning the substance. The Committee considered that the 
degree of risk to public health and society associated with the 
abuse liability of 25B-NBOMe is especially serious. Whilst the 
Committee noted its use in medical research, it has no recorded 
therapeutic use.
    The Committee considered that the evidence of its abuse 
warranted its placement under international control and recommended 
that 25B-NBOMe be placed in Schedule I of the Convention on 
Psychotropic Substances (1971).

25C-NBOMe
25C-NBOMe (2C-C-NBOMe) is chemically 2-(4-chloro-2,5-
dimethoxyphenyl)-N-[(2-methoxyphenyl)methyl]ethanamine.

    25C-NBOMe had not been previously pre-reviewed or critically 
reviewed. A direct critical review was proposed based on information 
brought to WHO's attention that 25C-NBOMe is clandestinely 
manufactured, of especially serious risk to public health and 
society, and of no recognized therapeutic use

[[Page 4286]]

by any party. Preliminary data collected from literature and 
different countries indicated that this substance may cause 
substantial harm and that it has no medical use.
    The Committee noted the challenges associated with the evidence 
base concerning the substance. The Committee considered that the 
degree of risk to public health and society associated with the 
abuse liability of 25C-NBOMe is especially serious. Whilst the 
Committee noted its use in medical research, it has no recorded 
therapeutic use. The Committee considered that the evidence of its 
abuse warranted its placement under international control and 
recommended that 25C-NBOMe be placed in Schedule I of the Convention 
on Psychotropic Substances (1971).

25I-NBOMe
25I-NBOMe (2C-I-NBOMe) is chemically 2-(4-iodo-2,5-dimethoxyphenyl)-
N-[(2-methoxyphenyl)methyl]ethanamine.

    25I-NBOMe had not been previously pre-reviewed or critically 
reviewed. A direct critical review was proposed based on information 
brought to WHO's attention that 25I-NBOMe is clandestinely 
manufactured, of especially serious risk to public health and 
society, and of no recognized therapeutic use by any party. 
Preliminary data collected from literature and different countries 
indicated that this substance may cause substantial harm and that it 
has no medical use.
    The Committee noted the challenges associated with the evidence 
base concerning the substance. The Committee considered that the 
degree of risk to public health and society associated with the 
abuse liability of 25I-NBOMe is especially serious. Whilst the 
Committee noted its use in medical research, it has no recorded 
therapeutic use. The Committee considered that the evidence of its 
abuse warranted its placement under international control and 
recommended that 25I-NBOMe be placed in Schedule I of the Convention 
on Psychotropic Substances (1971).
    Substances recommended to be scheduled in Schedule II of the 
Convention on Psychotropic Substances (1971):

N-benzylpiperazine (BZP)
N-benzylpiperazine (BZP) is an aryl-substituted piperazine and is 
chemically 1-benzyl-1,4-diazacyclohexane.

    BZP was pre-reviewed at the 35th ECDD meeting and based on the 
reported psychostimulant effects, evidence of abuse and adverse 
effects, the Expert Committee concluded that a critical review was 
warranted.
    BZP has been shown to have effects similar to amphetamine. The 
Committee considered that the degree of risk to public health and 
society associated with the abuse liability of BZP is substantial. 
Its therapeutic usefulness has been assessed to be little, as it is 
not currently licensed for use. The Committee considered that the 
evidence of its abuse warranted its placement under international 
control. The Committee recommended that BZP be placed in Schedule II 
of the Convention on Psychotropic Substances (1971).

JWH-018
JWH-018 is chemically naphthalen-1-yl(1-pentyl-1H-indol-3-
yl)methanone.

    JWH-018 had not been previously pre-reviewed or critically 
reviewed. A direct critical review was proposed based on information 
brought to WHO's attention that JWH-018 is clandestinely 
manufactured, of especially serious risk to public health and 
society, and of no recognized therapeutic use by any party. 
Preliminary data collected from literature and different countries 
indicated that this substance may cause substantial harm and that it 
has no medical use.
    The Committee noted the challenges associated with the evidence 
base concerning the substance. The Committee noted analytically 
confirmed cases of non-fatal and fatal intoxications involving JWH-
018. The Committee therefore considered that the degree of risk to 
public health associated with the abuse liability of JWH-018 is 
substantial. Its therapeutic usefulness has been assessed to be 
none. As per the Guidance on the WHO review of psychoactive 
substances for international control, higher regard was made to the 
substantial public health risk as opposed to the lack of therapeutic 
usefulness [p.18, paragraph 56, penultimate sentence]. The Committee 
recommended that JWH-018 be placed under international control in 
Schedule II of the Convention on Psychotropic Substances (1971).

AM-2201
AM-2201 is chemically [1-(5-fluoropentyl)-1H-indol-3-yl]-naphthalen-
1-ylmethanone.

    AM-2201 had not been previously pre-reviewed or critically 
reviewed. A direct critical review was proposed based on information 
brought to WHO's attention that AM-2201 is clandestinely 
manufactured, of especially serious risk to public health and 
society, and of no recognized therapeutic use by any party. 
Preliminary data collected from literature and different countries 
indicated that this substance may cause substantial harm and that it 
has no medical use.
    The Committee noted the challenges associated with the evidence 
base concerning the substance. The Committee noted analytically 
confirmed cases of non-fatal and fatal intoxications involving AM-
2201. The Committee therefore considered that the degree of risk to 
public health associated with the abuse liability of AM-2201 is 
substantial. Its therapeutic usefulness has been assessed to be 
none. As per the Guidance on the WHO review of psychoactive 
substances for international control, higher regard was made to the 
substantial public health risk as opposed to the lack of therapeutic 
usefulness [p.18, paragraph 56, penultimate sentence]. The Committee 
recommended that AM-2201 be placed under international control in 
Schedule II of the Convention on Psychotropic Substances (1971).

3,4-methylenedioxypyrovalerone (MDPV)
3,4-methylenedioxypyrovalerone (MDPV) is chemically (R,S)-1-(1,3-
benzodioxol-5-yl)-2-(pyrrolidin-1-yl)pentan-1-one.

    MDPV had not been previously pre-reviewed or critically 
reviewed. A direct critical review was proposed based on information 
brought to WHO's attention that MDPV is clandestinely manufactured, 
of especially serious risk to public health and society, and of no 
recognized therapeutic use by any party. Preliminary data collected 
from literature and different countries indicated that this 
substance may cause substantial harm and that it has no medical use.
    The Committee considered that the degree of risk to public 
health and society associated with the abuse liability of MDPV is 
substantial. Its therapeutic usefulness has been assessed to be 
none. The Committee considered that the evidence of its abuse 
warranted its placement under international control. As per the 
Guidance on the WHO review of psychoactive substances for 
international control, higher regard was made to the substantial 
public health risk as opposed to the lack of therapeutic usefulness 
[p.18 paragraph 56, penultimate sentence]. The Committee recommended 
that MDPV be placed in Schedule II of the Convention on Psychotropic 
Substances (1971).

Methylone (bk-MDMA)
Methylone (beta-keto-MDMA) is chemically (R,S)-1-(1,3-benzodioxol-5-
yl)-2-(methylamino)propan-1-one.

    Methylone had not been previously pre-reviewed or critically 
reviewed. A direct critical review was proposed based on information 
brought to WHO's attention that methylone is clandestinely 
manufactured, of especially serious risk to public health and 
society, and of no recognized therapeutic use by any party. 
Preliminary data collected from literature and different countries 
indicated that this substance may cause substantial harm and that it 
has no medical use.
    The Committee considered that the degree of risk to public 
health and society associated with the abuse liability of methylone 
is substantial. Its therapeutic usefulness has been assessed to be 
none. The Committee considered that the evidence of its abuse 
warranted its placement under international control. As per the 
Guidance on the WHO review of psychoactive substances for 
international control, higher regard was made to the substantial 
public health risk as opposed to the lack of therapeutic usefulness 
[p.18, paragraph 56, penultimate sentence]. The Committee 
recommended that methylone be placed in Schedule II of the 
Convention on Psychotropic Substances (1971).

Mephedrone
Mephedrone (4-methylmethcathinone, 4-MMC) is chemically (R,S)-2-
(methylamino)-1-(4-methylphenyl)propan-1-one.

    Mephedrone had not been previously pre-reviewed or critically 
reviewed. A direct critical review was proposed based on information 
brought to WHO's attention that mephedrone is clandestinely 
manufactured, of especially serious risk to public health and 
society, and of no recognized therapeutic use by any party. 
Preliminary data collected from literature and different countries 
indicated that this substance may cause substantial harm. A critical 
review was further undertaken by the Committee given that the 
Government of the United Kingdom of Great Britain and Northern 
Ireland had made a notification concerning a proposed recommendation 
for international control of mephedrone (4-methylmethcathinone), 
under

[[Page 4287]]

article 2, paragraphs 1 and 3 of the Convention on Psychotropic 
Substances, 1971.
    The Committee considered that the degree of risk to public 
health and society associated with the abuse liability of mephedrone 
is substantial. Its therapeutic usefulness has been assessed to be 
none. The Committee considered that the evidence of its abuse 
warranted its placement under international control. As per the 
Guidance on the WHO review of psychoactive substances for 
international control, higher regard was made to the substantial 
public health risk as opposed to the lack of therapeutic usefulness 
[p.18, paragraph 56, penultimate sentence].
    The Committee recommended that mephedrone be placed in Schedule 
II of the Convention on Psychotropic Substances (1971).

III. 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 the following: 
(1) Accept the WHO recommendations; (2) accept the recommendations to 
control, but control the drug substance in a schedule other than that 
recommended; or (3) reject the recommendations entirely.
    AH-7921, or 1-(3,4-dichlorobenzamidomethyl)cyclohexyldimethylamine, 
is an opioid analgesic drug substance selective for the [micro]-opioid 
receptor. The WHO ECDD met in June 2014 and recommended that AH-7921 be 
placed in Schedule I of the 1961 Single Convention. AH-7921 is not 
controlled under the CSA in the United States. As such, additional 
controls will be necessary to fulfill U.S. obligations if AH-7921 is 
controlled under Schedule I of the 1961 Single Convention.
    Gamma-butyrolactone (GBL) is used as an industrial solvent. GBL can 
be converted in the body to the central nervous system depressant drug 
gamma-hydroxybutyric acid (GHB). GBL is controlled as a List I chemical 
in the United States under the CSA. The WHO ECDD met in June 2014 and 
recommended that GBL be placed in Schedule I of the Psychotropic 
Convention. Additional controls will be necessary to fulfill U.S. 
obligations if GBL is controlled under Schedule I of the Psychotropic 
Convention.
    1,4-Butanediol is used as an industrial solvent for manufacturing 
and also used for the synthesis of GBL. 1,4-Butanediol can also be 
converted to the central nervous depressant drug GHB. It has no medical 
use in the United States. 1,4-Butanediol is not controlled under the 
CSA in the United States, but it is subject to controls in several 
States under state law. 1,4-Butanediol was reviewed by the WHO ECDD at 
its 36th meeting, at which the WHO ECDD recommended that 1,4-butanediol 
be placed in Schedule I of the Psychotropic Convention. Additional 
controls will be necessary to fulfill U.S. obligations if 1,4-
butanediol is controlled under Schedule I of the Psychotropic 
Convention.
    The substances 25B-NBOMe (2C-B-NBOMe), 25C-NBOMe (2C-C-NBOMe), and 
25I-NBOMe (2C-I-NBOMe) are synthetic 2C phenethylamine substances and 
were developed for use in mapping and investigating the serotonin 
receptors in the mammalian brain. The WHO ECDD at its 36th meeting 
recommended that 25B-NBOMe, 25C-NBOMe, and 25I-NBOMe be placed in 
Schedule I of the Psychotropic Convention. On November 15, 2013, 25B-
NBOMe, 25C-NBOMe, and 25I-NBOMe were temporarily placed in Schedule I 
of the CSA under the temporary scheduling provision of section 201(h) 
of the CSA. These provisions provide the Attorney General with the 
authority to temporarily place a substance into Schedule I of the CSA 
for 2 years, without regard to the requirements of 21 U.S.C. 811(b), if 
he finds that such action is necessary to avoid an imminent hazard to 
the public safety. In addition, if proceedings to control a substance 
are initiated under 21 U.S.C. 811(a)(1), the Attorney General may 
extend the temporary scheduling for up to 1 year (21 U.S.C. 811(h)(2)). 
Therefore, considering the previously mentioned time limitations of 
temporary scheduling under section 201(h) of the CSA, additional 
controls will be necessary to fulfill U.S. obligations if 25B-NBOMe, 
25C-NBOMe, and 25I-NBOMe are controlled under Schedule I of the 
Psychotropic Convention.
    N-benzylpiperazine (BZP) is used as an intermediate in chemical 
synthesis but has been taken orally as either powder or tablets and by 
other routes, including smoking or snorting. It has no medical use in 
the United States. The WHO ECDD at its 36th meeting recommended that 
BZP be placed in Schedule II of the Psychotropic Convention on 
Psychotropic Substances (1971). BZP is controlled in Schedule I under 
the CSA in the United States. As such, no additional controls will be 
necessary to fulfill U.S. obligations if these substances are 
controlled under Schedule II of the Psychotropic Convention.
    The substances 1-pentyl-1H-indol-3-yl)-1-naphthalenyl-methanone 
(JWH-018) and [1-(5-fluoropentyl)-1H-indol-3-yl]-1-naphthalenyl-
methanone (AM-2201) are classified as synthetic cannabinoids with 
pharmacological properties like tetrahydrocannabinol. The WHO ECDD at 
its 36th meeting recommended that JWH-018 and AM-2201 be placed in 
Schedule II of the Psychotropic Convention. These two substances are 
controlled in Schedule I under the CSA in the United States. As such, 
no additional controls will be necessary to fulfill U.S. obligations if 
JWH-018 and AM-2201 are controlled under Schedule II of the 
Psychotropic Convention.
    The substances 3,4-methylenedioxypyrovalerone (MDPV), 3,4-
methylenedioxy-N-methylcathinone (beta-keto-MDMA; methylone), and 4-
methylmethcathinone (4-MMC; mephedrone) are classified as synthetic 
cathinones in the phenethylamine class and are structurally and 
pharmacologically similar to amphetamine. The WHO ECDD at its 36th 
meeting recommended that MDPV, methylone, and mephedrone be placed in 
Schedule II of the Psychotropic Convention. MDPV, methylone, and 
mephedrone are controlled in Schedule I under the CSA in the United 
States. As such, no additional controls will be necessary to fulfill 
U.S. obligations if these three substances are controlled under 
Schedule II of the Psychotropic Convention.
    In addition to the above substances recommended for international 
control by the WHO Expert Committee at its 36th meeting, the United 
Nations Economic and Social Council published recommendations for 
action to be taken by the CND at the March 2015 meeting (http://www.un.org/Docs/journal/asp/ws.asp?m=E/CN.7/2015/7). Among these 
recommendations is that the CND should decide whether it wishes to 
place ketamine in Schedule I of the Psychotropic Convention or, if not, 
what other action, if any, might be required. Pursuant to article 2, 
paragraph 1, of the Convention on Psychotropic Substances of 1971, the 
Government of China, in its correspondence dated 8 March 2014, notified 
the Secretary-General of the United Nations that China recommended that 
ketamine be placed in Schedule I of the 1971 Convention. In accordance 
with article 2 of the Psychotropic Convention, this proposal has been 
recommended for consideration by the CND.
    Ketamine is classified as a rapid-acting general anesthetic agent 
used for short diagnostic and surgical procedures that do not require 
skeletal muscle relaxation. It is marketed in the United States as an 
injectable. Ketamine is controlled in Schedule III of the CSA in

[[Page 4288]]

the United States. It is not controlled internationally under the 
Convention on Psychotropic Substances or the Single Convention on 
Narcotic Drugs. The WHO Expert Committee on Drug Dependence reviewed 
ketamine at its 34th, 35th, and 36th meetings. Ketamine is controlled 
in schedule III of the CSA in the United States, and additional 
controls may be necessary to fulfill U.S. obligations if ketamine is 
controlled under Schedule I of the Psychotropic Convention. FDA, on 
behalf of the Secretary of HHS, invites interested persons to submit 
comments on the notifications from the United Nations concerning these 
drug substances. FDA, in cooperation with the National Institute on 
Drug Abuse, will consider the comments on behalf of HHS in evaluating 
the WHO scheduling recommendations. Then, under section 201(d)(2)(B) of 
the CSA, HHS will recommend to the Secretary of State what position the 
United States should take when voting on the recommendations for 
control of substances under the Psychotropic Convention at the CND 
meeting in March 2015.
    Comments regarding the WHO recommendations for control of AH-7921 
under the 1961 Single Convention will also be forwarded to the relevant 
Agencies for consideration in developing the U.S. position regarding 
narcotic substances at the CND meeting.

IV. Submission of Comments and Opportunity for Public Meeting

    Interested persons may submit either electronic comments regarding 
this document to http://www.regulations.gov or written comments to the 
Division of Dockets Management (see ADDRESSES). It is only necessary to 
send one set of comments. Identify comments with the docket number 
found in brackets in the heading of this document. Received comments 
may be seen in the Division of Dockets Management between 9 a.m. and 4 
p.m., Monday through Friday, and will be posted to the docket at http://www.regulations.gov.
    FDA does not presently plan to hold a public meeting. If any person 
believes that, in addition to written comments, a public meeting would 
contribute to the development of the U.S. position on the substances to 
be considered for control under the Psychotropic Convention, a request 
for a public meeting and the reasons for such a request should be sent 
to James R. Hunter (see FOR FURTHER INFORMATION CONTACT) on or before 
February 6, 2015.
    The short time period for the submission of comments and requests 
for a public meeting is needed to ensure that HHS may, in a timely 
fashion, carry out the required action and be responsive to the United 
Nations.

    Dated: January 21, 2015.
Leslie Kux,
Associate Commissioner for Policy.
[FR Doc. 2015-01408 Filed 1-26-15; 8:45 am]
BILLING CODE 4164-01-P


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