International Drug Scheduling; Convention on Psychotropic Substances; Single Convention on Narcotic Drugs; World Health Organization; Scheduling Recommendations; Carfentanil;4-fluoroamphetamine (4-FA) and Ten Other Substances; Request for Comments, 3741-3748 [2018-01471]
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Federal Register / Vol. 83, No. 18 / Friday, January 26, 2018 / Notices
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II. Electronic Access
Persons with access to the internet
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Guidances/default.htm or https://
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Dated: January 19, 2018.
Leslie Kux,
Associate Commissioner for Policy.
[FR Doc. 2018–01350 Filed 1–25–18; 8:45 am]
BILLING CODE 4164–01–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA–2018–N–0181]
International Drug Scheduling;
Convention on Psychotropic
Substances; Single Convention on
Narcotic Drugs; World Health
Organization; Scheduling
Recommendations; Carfentanil;
4-fluoroamphetamine (4–FA) and Ten
Other Substances; Request for
Comments
AGENCY:
Food and Drug Administration,
HHS.
ACTION:
Notice; request for comments.
The Food and Drug
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
distributing restrictions, under
international treaties, on certain drug
substances. The comments received in
response to this notice 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 2018. This
notice is issued under the Controlled
Substances Act (CSA).
DATES: Submit either electronic or
written comments by February 26, 2018.
ADDRESSES: You may submit comments
as follows. Please note that late,
untimely filed comments will not be
considered. Electronic comments must
be submitted on or before February 26,
2018. The https://www.regulations.gov
electronic filing system will accept
comments until midnight Eastern Time
at the end of February 26, 2018.
Comments received by mail/hand
delivery/courier (for written/paper
submissions) will be considered timely
if they are postmarked or the delivery
SUMMARY:
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service acceptance receipt is on or
before that date.
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Electronic Submissions
Submit electronic comments in the
following way:
• Federal eRulemaking Portal:
https://www.regulations.gov. Follow the
instructions for submitting comments.
Comments submitted electronically,
including attachments, to https://
www.regulations.gov will be posted to
the docket unchanged. Because your
comment will be made public, you are
solely responsible for ensuring that your
comment does not include any
confidential information that you or a
third party may not wish to be posted,
such as medical information, your or
anyone else’s Social Security number, or
confidential business information, such
as a manufacturing process. Please note
that if you include your name, contact
information, or other information that
identifies you in the body of your
comments, that information will be
posted on https://www.regulations.gov.
• If you want to submit a comment
with confidential information that you
do not wish to be made available to the
public, submit the comment as a
written/paper submission and in the
manner detailed (see ‘‘Written/Paper
Submissions’’ and ‘‘Instructions’’).
Written/Paper Submissions
Submit written/paper submissions as
follows:
• Mail/Hand delivery/Courier (for
written/paper submissions): Dockets
Management Staff (HFA–305), Food and
Drug Administration, 5630 Fishers
Lane, Rm. 1061, Rockville, MD 20852.
• For written/paper comments
submitted to the Dockets Management
Staff, FDA will post your comment, as
well as any attachments, except for
information submitted, marked and
identified, as confidential, if submitted
as detailed in ‘‘Instructions.’’
Instructions: All submissions received
must include the Docket No. FDA–
2018–N–0181 for ‘‘International Drug
Scheduling; Convention on
Psychotropic Substances; Single
Convention on Narcotic Drugs; World
Health Organization; Scheduling
Recommendations; Carfentanil; 4fluoroamphetamine (4–FA) and Ten
Other Substances; Request for
Comments.’’ Received comments, those
filed in a timely manner (see
ADDRESSES), will be placed in the docket
and, except for those submitted as
‘‘Confidential Submissions,’’ publicly
viewable at https://www.regulations.gov
or at the Dockets Management Staff
between 9 a.m. and 4 p.m., Monday
through Friday.
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• Confidential Submissions—To
submit a comment with confidential
information that you do not wish to be
made publicly available, submit your
comments only as a written/paper
submission. You should submit two
copies total. One copy will include the
information you claim to be confidential
with a heading or cover note that states
‘‘THIS DOCUMENT CONTAINS
CONFIDENTIAL INFORMATION.’’ The
Agency will review this copy, including
the claimed confidential information, in
its consideration of comments. The
second copy, which will have the
claimed confidential information
redacted/blacked out, will be available
for public viewing and posted on
https://www.regulations.gov. Submit
both copies to the Dockets Management
Staff. If you do not wish your name and
contact information to be made publicly
available, you can provide this
information on the cover sheet and not
in the body of your comments and you
must identify this information as
‘‘confidential.’’ Any information marked
as ‘‘confidential’’ will not be disclosed
except in accordance with 21 CFR 10.20
and other applicable disclosure law. For
more information about FDA’s posting
of comments to public dockets, see 80
FR 56469, September 18, 2015, or access
the information at: https://www.gpo.gov/
fdsys/pkg/FR-2015-09-18/pdf/201523389.pdf.
Docket: For access to the docket to
read background documents or the
electronic and written/paper comments
received, go to https://
www.regulations.gov and insert the
docket number, found in brackets in the
heading of this document, into the
‘‘Search’’ box and follow the prompts
and/or go to the Dockets Management
Staff, 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,
james.hunter@fda.hhs.gov.
SUPPLEMENTARY INFORMATION:
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
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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 SecretaryGeneral of the United Nations (the
Secretary-General) regarding six
substances to be considered for control
under the Psychotropic Convention.
This notification reflects the
recommendation from the 39th WHO
Expert Committee for Drug Dependence
(ECDD), which met in November 2017.
In the Federal Register of August 14,
2017 (82 FR 37866), 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 six substances 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, to provide interested and
affected persons an opportunity to
submit comments regarding the WHO
recommendations for narcotic drugs, the
notification regarding these substances
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 these substances. The HHS
recommendations are not binding on the
representative of the United States in
discussions and negotiations relating to
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the proposal regarding control of
substances under the 1961 Single
Convention.
The short 30-day time period for the
submission of comments is needed to
ensure that Health and Human Services
may, in a timely fashion, carry out the
required action and be responsive to the
United Nations.
II. United Nations Notification
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The formal notification from the
United Nations that identifies the drug
substances and explains the basis for the
recommendations is reproduced as
follows (non-relevant text removed):
Reference:
NAR/CL.4/2017
WHO/ECDD39; 1961C–Art.3; 1971C–Art.2
CU 2017/437/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 1 and
4 of the Convention on Psychotropic
Substances of 1971 (1971 Convention)
notified the Secretary-General of the
following recommendations:
Substances recommended to be placed in
Schedules I and IV of the Single Convention
on Narcotic Drugs (1961), as amended by the
1972 Protocol:
Carfentanil
Chemical name: Methyl 1-(2-phenylethyl)4-[phenyl(propanoyl) amino]piperidine4-carboxylate
Substances recommended to be placed in
Schedule I of the Single Convention on
Narcotic Drugs (1961), as amended by the
1972 Protocol:
Ocfentanil
Chemical name: N-(2-Fluorophenyl)-2methoxy-N-[1-(2-phenylethyl)piperidin4-yl]acetamide
Furanyl fentanyl
Chemical name: N-Phenyl-N-[1-(2phenylethyl)piperidin-4-yl]furan-2carboxamide
Acryloylfentanyl (Acryl fentanyl)
Chemical name: N-Phenyl-N-[1-(2phenylethyl)piperidin-4-yl]prop-2enamide
4-Fluoroisobutyryl fentanyl (4–FIBF, pFIBF)
Chemical name: N-(4-Fluorophenyl)-2methyl-N-[1-(2-phenylethyl)piperidin-4yl]propanamide
Tetrahydrofuranylfentanyl (THF–F)
Chemical name: N-Phenyl-N-[1-(2phenylethyl)piperidin-4-yl]oxolane-2carboxamide
Substances recommended to be placed in
Schedule II of the Convention on
Psychotropic Substances (1971):
AB–CHMINACA
Chemical name: N-[(2S)-1-Amino-3methyl-1-oxobutan-2-yl]-1-
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(cyclohexylmethyl)-1H-indazole-3carboxamide
5F–ADB (5F–MDMB–PINACA)
Chemical name: Methyl (2S)-2-{[1-(5fluoropentyl)-1H-indazole-3carbonyl]amino}-3,3-dimethylbutanoate
AB–PINACA
Chemical name: N-[(2S)-1-Amino-3methyl-1-oxobutan-2-yl]-1-pentyl-1Hindazole-3-carboxamide
UR–144
Chemical name: (1-Pentyl-1H-indol-3yl)(2,2,3,3tetramethylcyclopropyl)methanone
5F–PB–22
Chemical name: Quinolin-8-yl 1-(5fluoropentyl)-1H-indole-3-carboxylate
4-Fluoroamphetamine (4–FA)
Chemical name: 1-(4Fluorophenyl)propan-2-amine
In addition, in the letter from the DirectorGeneral of the World Health Organization to
the Secretary-General, reference is also made
to the recommendations by the thirty-ninth
meeting of the WHO Expert Committee on
Drug Dependence (ECDD) for carrying out a
critical review of preparations containing
almost exclusively cannabidiol (CBD),
Pregabalin, and Tramadol at a subsequent
Expert Committee meeting, as well as for
Etizolam to remain under surveillance.
Furthermore, the letter also makes reference
to the recommendation by the Expert
Committee with regard to cannabis and its
component substances.
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 sixtyfirst session of the Commission on Narcotic
Drugs (12–16 March 2018).
In connection with the notification, WHO
has also submitted the relevant extract from
the report of the thirty-ninth meeting of the
WHO Expert Committee on Drug Dependence
which is hereby transmitted as Annex II.
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 that are recommended by WHO to
be placed under international control under
the 1961 Convention (namely: Carfentanil,
Ocfentanil, Furanyl fentanyl,
Acryloylfentanyl (Acryl fentanyl), 4Fluoroisobutyryl fentanyl (4–FIBF, pFIBF),
and Tetrahydrofuranylfentanyl (THF–F)) and
the 1971 Convention (namely: AB
CHMINACA, 5F–ADB (5F–MDMB–PINACA),
AB–PINACA, UR–144, 5F–PB–22 and 4Fluoroamphetamine (4–FA)).
Communications are to be sent at the latest
by 2 February 2018 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, e-mail:
sgb@unodc.org.
28 December 2017
His Excellency
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Mr. Rex Tillerson
Secretary of State of the United States of
America
Annex I
Letter Addressed to the Secretary-General of
the United Nations From the DirectorGeneral of the World Health Organization
‘‘The Thirty-Ninth meeting of the WHO
Expert Committee on Drug Dependence
convened from 6 to 10 November 2017, at
WHO headquarters in Geneva. The objective
of this meeting was to carry out an in-depth
evaluation of psychoactive substances in
order to determine whether or not WHO
should recommend these substances to be
placed under international control.
With reference to Article 2, paragraphs 1
and 4 of the Convention on Psychotropic
Substances (1971) and Article 3, paragraphs
1 and 3 of the Single Convention on Narcotic
Drugs (1961), as amended by the 1972
Protocol, I am pleased to submit
recommendations of the World Health
Organization as follows:
To be placed in Schedules I and IV of the
Single Convention on Narcotic Drugs (1961):
—Carfentanil
chemical name: Methyl 1-(2-phenylethyl)4- [phenyl(propionoyl)
amino]piperidine-4-carboxylate
To be placed in Schedule I of the Single
Convention on Narcotic Drugs (1961):
—Ocfentanil
chemical name: N-(2-Fluorophenyl)-2methoxy-N-[1-(2-phenylethyl)piperidin4-yl]acetamide
—Furanyl fentanyl
chemical name: N-Phenyl-N-[1-(2phenylethyl)piperidin-4-yl]furan-2carboxamide
—Acryloylfentanyl (Acryl fentanyl)
chemical name: N-Phenyl-N-[1-(2phenylethyl)piperidin-4-yl]prop-2enamide
—4-Fluoroisobutyryl fentanyl (4–FIBF,
pFIBF)
chemical name: N-(4-Fluorophenyl)-2methyl-N-[1-(2-phenylethyl)piperidin-4yl]propanamide
—Tetrahydrofuranylfentanyl (THF–F)
chemical name: N-Phenyl-N-[1-(2phenylethyl)piperidin-4-yl]oxolane-2carboxamide
To be placed in Schedule II of the
Convention on Psychotropic Substances
(1971):
—AB–CHMINACA
chemical name: N-[(2S)-1-Amino-3methyl-1-oxobutan-2-yl]-1(cyclohexylmethyl)-lH-indazole-3carboxamide
—5F–ADB (5F–MDMB–PINACA)
chemical name: Methyl (2S)-2-{[l-(5fluoropentyl)-1H-indazole-3-carbonyl]
amino}-3,3-dimethylbutanoate
—AB–PINACA
chemical name: N-[(2S)-1-Amino-3methyl-1-oxobutan-2-yl]-1-pentyl-1Hindazole-3-carboxamide
—UR–144
chemical name: (1-Pentyl-1H-indol-3yl)(2,2,3,3tetramethylcyclopropyl)methanone
—5F–PB–22
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chemical name: Quinolin-8-yl 1-(5fluoropentyl)-l H-indole-3-carboxylate
—4-Fluoroamphetamine (4–FA)
chemical name: 1-(4-Fluorophenyl)propan2-amine
In addition, the Expert Committee
recommended to carry out a critical review
at a subsequent Expert Committee meeting
for:
—Preparations containing almost exclusively
cannabidiol (CBD)
chemical name: (1′R,2′R)-5′-Methyl-4pentyl-2′-(prop-1-en-2-yl)-1′,2′,3′,4′tetrahydro-[1,l′biphenyl]-2,6-diol
—Pregabalin
chemical name: (3S)-3-(Aminomethyl)-5methylhexanoic acid
—Tramadol
chemical name: rac-(1R,2R)-2[(Dimethylamino)methyl]-1-(3methoxyphenyl)cyclohexan-1-ol
It also recommended that the following
substance remain under surveillance:
—Etizolam (INN)
chemical name: 4-(2-Chlorophenyl)-2ethyl-9-methyl-6H-thieno[3,2:/]
[1,2,4]triazolo[4,3-a][1,4]diazepine
The recommendations and the assessments
and findings on which they are based are set
out in detail in the Report of the 39th Expert
Committee on Drug Dependence, which is
the Committee that advises me on these
issues. An extract of the Committee’s Report
is attached in Annex 1 to this letter.
I am very pleased with the ongoing
collaboration among the United Nations
Office on Drugs and Crime (UNODC),
International Narcotics Control Board (INCB)
and WHO, in particular, how this
collaboration has supported the work of the
WHO Expert Committee on Drug
Dependence, and more generally, the
implementation of operational
recommendations from the United Nations
General Assembly Special Session (UNGASS)
2016.
I would like to take this opportunity to
inform you that the 40th Expert Committee
on Drug Dependence will take place in May
2018 and will be specifically dedicated to the
pre review of cannabis and its major
components substances.’’
Annex II
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Extract From the Report of the 39th Expert
Committee on Drug Dependence
Substances recommended to be scheduled
in Schedule I and Schedule IV of the Single
Convention on Narcotic Drugs (1961), as
amended by the 1972 Protocol:
Carfentanil
Chemically, carfentanil is Methyl 1-(2phenylethyl)-4[phenyl(propionoyl)amino]piperidine-4carboxylate. Carfentanil has no
stereoisomers.
Carfentanil has not been previously prereviewed or critically reviewed. A
notification was received from a Party to the
Conventions thus initiating a critical review.
Carfentanil is convertible into sufentanil
and alfentanil, two very potent opioid
analgesics controlled as Schedule I drugs
under the Single Convention on Narcotic
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Drugs of 1961. It is a m-opioid receptor
agonist, and its pharmacodynamic and
clinical effects are similar to fentanyl but it
is about 100 times more potent. It binds to
opioid receptors, and produces respiratory
depression, decreased consciousness,
antinociception, and miosis. The substance
has been associated with hundreds of deaths
and nonfatal intoxications globally, and it
has created significant concerns in a number
of countries. Due to the extremely small
doses that induce lethal effects, it poses a
particularly serious threat to public health.
Carfentanil is a compound liable to similar
abuse and with similar ill effects to
controlled opioids such as fentanyl that are
included in Schedule I of the Single
Convention on Narcotic Drugs of 1961. There
is sufficient evidence that it 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. Thus, because it meets
the required condition of similarity, it is
recommended that carfentanil (Methyl 1-(2phenylethyl)-4[phenyl(propionoyl)amino]piperidine-4carboxylate) be placed in Schedule I of the
Single Convention on Narcotic Drugs of 1961,
as consistent with Article 3, paragraph 3 (iii)
of that Convention in that the substance is
liable to similar abuse and productive of
similar ill effects to drugs in Schedule I.
The Committee considered and recognized
the impact that international scheduling
could have on veterinary access to carfentanil
in relation to its therapeutic use in large
animals. However, the Committee was
particularly concerned regarding the extreme
potency of the substance and serious risk to
public health. The Committee felt that the
therapeutic advantages did not offset the
severe threat to human health. As such, and
with consideration that substances in
Schedule IV afford Parties the opportunity to
adopt special measures for drugs with
particularly dangerous properties, the
Committee recommended that carfentanil
(Methyl 1-(2-phenylethyl)-4[phenyl(propionoyl)amino]piperidine-4carboxylate) be also placed in Schedule IV of
the Single Convention on Narcotic Drugs of
1961.
Substances recommended to be placed in
Schedule I of the Single Convention on
Narcotic Drugs (1961), as amended by the
1972 Protocol:
Ocfentanil
Chemically, ocfentanil is N-(2Fluorophenyl)-2-methoxy-N-[1-(2phenylethyl)piperidin-4-yl]acetamide. It has
no stereoisomers.
Ocfentanil has not been previously prereviewed or critically reviewed. A direct
critical review was proposed based on
information brought to the attention of WHO
that ocfentanil is clandestinely
manufactured, poses a risk to public health
and society, and has no recognized
therapeutic use by any party.
Ocfentanil is an opioid that is structurally
related to fentanyl that is regulated under
Schedule I of the Single Convention on
Narcotic Drugs of 1961, and produces opioid
effects including analgesia, euphoria,
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sedation, and potentially serious respiratory
depression. Ocfentanil-related deaths have
been reported, and it has come under
national control in several countries in
different regions of the world.
Ocfentanil is a compound liable to similar
abuse and with similar ill effects to
controlled opioids such as fentanyl that are
included in Schedule I of the Single
Convention on Narcotic Drugs of 1961. It has
no recorded therapeutic use, and its use has
been associated with fatalities. There is
sufficient evidence that it 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. Thus, because it meets the required
condition of similarity, it is recommended
that ocfentanil (N-(2-Fluorophenyl)-2methoxy-N-[1-(2-phenylethyl)piperidin-4yl]acetamide) be placed in Schedule I of the
Single Convention on Narcotic Drugs of 1961,
as consistent with Article 3, paragraph 3 (iii)
of that Convention in that the substance is
liable to similar abuse and productive of
similar ill effects to drugs in Schedule I.
Furanyl fentanyl
Chemically, furanyl fentanyl is N-PhenylN-[1-(2-phenylethyl)piperidin-4-yl]furan-2carboxamide. Furanyl fentanyl has no
stereoisomers.
Furanyl fentanyl has not been previously
pre-reviewed or critically reviewed. A direct
critical review was proposed based on
information brought to WHO’s attention that
furanyl fentanyl is clandestinely
manufactured, of especially serious risk to
public health and society, and of no
recognized therapeutic use by any party.
Furanyl fentanyl is a compound liable to
similar abuse and with similar ill effects to
controlled opioids such as fentanyl that are
included in Schedule I of the Single
Convention on Narcotic Drugs of 1961. It has
no recorded therapeutic use and its use has
been associated with fatalities. There is
sufficient evidence that it 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. Thus, because it meets the required
condition of similarity, it is recommended
that furanyl fentanyl (N-Phenyl-N-[1-(2phenylethyl)piperidin-4-yl]furan-2carboxamide) be placed in Schedule I of the
Single Convention on Narcotic Drugs of 1961,
as consistent with Article 3, paragraph 3 (iii)
of that Convention in that the substance is
liable to similar abuse and productive of
similar ill effects to drugs in Schedule I.
Acryloylfentanyl (Acryl fentanyl)
Chemically, acryloylfentanyl is N-PhenylN-[1-(2-phenylethyl)piperidin-4-yl]prop-2enamide. It has no stereoisomers.
Acryloylfentanyl has not been previously
pre-reviewed or critically reviewed. A direct
critical review was proposed based on
information brought to WHO’s attention that
acryloylfentanyl is clandestinely
manufactured, of especially serious risk to
public health and society, and of no
recognized therapeutic use by any party.
Acryloylfentanyl is a compound liable to
similar abuse and with similar ill effects to
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controlled opioids such as fentanyl that are
included in Schedule I of the Single
Convention on Narcotic Drugs of 1961. It has
no recorded therapeutic use, and its use has
been associated with fatalities. There is
sufficient evidence that it 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. Thus, because it meets the required
condition of similarity, it is recommended
that acryloylfentanyl (N-Phenyl-N-[1-(2phenylethyl)piperidin-4-yl]prop-2-enamide)
be placed in Schedule I of the Single
Convention on Narcotic Drugs of 1961, as
consistent with Article 3, paragraph 3 (iii) of
that Convention in that the substance is
liable to similar abuse and productive of
similar ill effects to drugs in Schedule I.
daltland on DSKBBV9HB2PROD with NOTICES
4-Fluoroisobutyryl fentanyl (4–FIBF, pFIBF)
Chemically, 4-fluoroisobutyryl fentanyl (4–
FIBF, pFIBF) is N-(4-Fluorophenyl)-2-methylN-[1-(2-phenylethyl)piperidin-4yl]propanamide.
4-Fluoroisobutyryl fentanyl has not been
previously pre-reviewed or critically
reviewed. A direct critical review was
proposed based on information brought to
WHO’s attention that it is clandestinely
manufactured, of especially serious risk to
public health and society, and of no
recognized therapeutic use by any party.
4-Fluoroisobutyryl fentanyl is a compound
liable to similar abuse and with similar ill
effects to controlled opioids such as fentanyl
that are included in Schedule I of the Single
Convention on Narcotic Drugs of 1961. It has
no recorded therapeutic use, and its use has
been associated with fatalities. There is
sufficient evidence that it 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. Thus, because it meets the required
condition of similarity, it is recommended
that 4-fluoroisobutyryl fentanyl (N-(4Fluorophenyl)-2-methyl-N-[l-(2phenylethyl)piperidin-4-yl]propanamide) be
placed in Schedule I of the Single
Convention on Narcotic Drugs of 1961, as
consistent with Article 3, paragraph 3 (iii) of
that Convention in that the substance is
liable to similar abuse and productive of
similar ill effects to drugs in Schedule I.
Tetrahydrofuranylfentanyl (THF–F)
Chemically, tetrahydrofuranylfentanyl is
N-Phenyl-N-[1-(2-phenylethyl)piperidin-4yl]oxolane-2-carboxamide.
Tetrahydrofuranylfentanyl contains a
stereogenic centre allowing for the existence
of a pair of enantiomers, (S)tetrahydrofuranylfentanyl and (R)tetrahydrofuranylfentanyl. There is no
information on the actual enantiomers found
on the illicit drug market at the time of the
report.
Tetrahydrofuranylfentanyl has not been
previously pre-reviewed or critically
reviewed. A direct critical review was
proposed based on information brought to
WHO’s attention that
tetrahydrofuranylfentanyl is clandestinely
manufactured, of especially serious risk to
public health and society, and of no
recognized therapeutic use by any party.
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Tetrahydrofuranylfentanyl is a compound
liable to similar abuse and with similar ill
effects to controlled opioids such as fentanyl
that are included in Schedule I of the Single
Convention on Narcotic Drugs of 1961. It has
no recorded therapeutic use, and its use has
been associated with fatalities. There is
sufficient evidence that it 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. Thus, because it meets the required
condition of similarity, it is recommended
that tetrahydrofuranylfentanyl (N-Phenyl-N[1-(2-phenylethyl)piperidin-4-yl]oxolane-2carboxamide) be placed in Schedule I of the
Single Convention on Narcotic Drugs of 1961,
as consistent with Article 3, paragraph 3 (iii)
of that Convention in that the substance is
liable to similar abuse and productive of
similar ill effects to drugs in Schedule I.
Substances recommended to be scheduled
in Schedule II of the Convention on
Psychotropic Substances (1971):
AB–CHMINACA
Chemically, AB–CHMINACA is N-[(2S)-lAmino-3-methyl-1-oxobutan-2-yl]-1(cyclohexylmethyl)-lHindazole-3carboxamide. AB–CHMINACA contains a
chiral centre, so that two enantiomers exist:
(R)-ABCHMINACA and (S)-AB–CHMINACA.
Based on the literature and the most likely
precursors to be used in manufacture, an (S)configuration of the stereocenter should be
expected.
AB–CHMINACA has not been previously
pre-reviewed or critically reviewed. A direct
critical review was proposed based on
information brought to WHO’s attention that
AB–CHMINACA is clandestinely
manufactured, of especially serious risk to
public health and society, and of no
recognized therapeutic use by any party.
AB–CHMINACA is a synthetic
cannabinoid receptor agonist. It is
clandestinely manufactured and sold under a
variety of brand names. Its mode of action
suggests also the potential for dependence
and likelihood of misuse. Effects of AB–
CHMINACA are consistent with those of
synthetic cannabinoid receptor agonists and
include relaxation, euphoria,
depersonalization, distorted perception of
time, impaired motor performance,
hallucinations, paranoia, confusion, fear,
anxiety, tachycardia, and nausea and
vomiting. Its cannabimimetic effects are more
potent than those of THC, which is listed in
Schedule II in the Convention on
Psychotropic Substances of 1971. There is
evidence of an increase in number of persons
using AB–CHMINACA in many countries
that have included fatal and non-fatal cases.
This substance causes substantial harm and
has no therapeutic usefulness. AB–
CHMINACA has similar abuse and similar ill
effects as other synthetic cannabinoids
receptor agonists already scheduled in
Schedule II of the Convention on
Psychotropic Substances of 1971. The
Committee recommended that AB–
CHMINACA (N-[(2S)-l-Amino-3-methyl-1oxobutan-2-yl]-1-(cyclohexylmethyl)-1Hindazole-3-carboxamide) be placed in
Schedule II under the Convention on
Psychotropic Substances of 1971.
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5F–ADB/5F–MDMB–PINACA
Chemically, 5F–ADB (also known as 5F–
MDMB–PINACA) is Methyl (2S)-2-{[l-(5fluoropentyl)-1Hindazole-3-carbonyl]amino}3,3-dimethylbutanoate. 5F–ADB contains a
chiral centre, so that two enantiomers exist:
(R)–5F–ADB and (S)–5F–ADB.
5F–ADB has not been previously prereviewed or critically reviewed. A direct
critical review was proposed based on
information brought to WHO’s attention that
5F–ADB is clandestinely manufactured, of
especially serious risk to public health and
society, and of no recognized therapeutic use
by any party.
5F–ADB is a synthetic cannabinoid
receptor agonist. It has cannabimimetic
effects that are more potent than those of
THC and MDMB–CHMICA, substances
which are listed in Schedule II of the
Convention on Psychotropic Substances of
1971. Its mode of action suggests the
potential for dependence and likelihood of
abuse. There is evidence of an increase in
number of persons using 5F–ADB in many
countries that have included fatal and nonfatal cases. This substance causes substantial
harm and has no therapeutic usefulness. The
Committee recommended that 5F–ADB, also
known as 5F–MDMB–PINACA, (Methyl (2S)2-{[l-(5-fluoropentyl)-1H-indazole-3carbonyl]amino}-3,3-dimethylbutanoate) be
placed in Schedule II under the Convention
on Psychotropic Substances of 1971.
AB–PINACA
Chemically, AB–PINACA is N-[(2S)-1Amino-3-methyl-1-oxobutan-2-yl]-1-pentyl1H-indazole-3-carboxamide. AB–PINACA
has stereoisomers.
AB–PINACA has not been previously prereviewed or critically reviewed. A direct
critical review was proposed based on
information brought to WHO’s attention that
AB–PINACA is clandestinely manufactured,
of especially serious risk to public health and
society, and of no recognized therapeutic use
by any party.
The Committee considered that the degree
of risk to public health and society associated
with the abuse of AB–PINACA is substantial.
Therapeutic usefulness has not been
recorded. It recognized that AB–PINACA has
similar abuse and similar ill-effects to other
synthetic cannabinoids receptor agonists in
Schedule II of the Convention on
Psychotropic Substances of 1971. The
Committee considered that there is sufficient
evidence that AB–PINACA 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 Committee
recommended that ABPINACA (N-[(2S)-lAmino-3-methyl-1-oxobutan-2-yl]-1-pentyl1H -indazole-3-carboxamide) be placed in
Schedule II under the Convention on
Psychotropic Substances of 1971.
UR–144
Chemically, UR–144 is (1-Pentyl-1H-indol3-yl)(2,2,3,3tetramethylcyclopropyl)methanone. It has no
stereoisomers.
UR–144 was previously critically reviewed
by the 36th ECDD in 2014. The Committee
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recommended that UR–144 not be placed
under international control at that time but
be kept under surveillance.
Of particular significance to the Committee
was the lack of analytically confirmed cases
of non-fatal and fatal intoxications at the time
involving solely UR–144. Subsequent data
collected from the literature and from
different countries indicating that this
substance may cause substantial harm and
that it has no medical use, warranted an
updated critical review.
The Committee considered that the degree
of risk to public health and society associated
with the abuse of UR–144 is substantial.
Therapeutic usefulness has not been
recorded. It recognized that UR–144 has
similar abuse and similar ill-effects to other
synthetic cannabinoids receptor agonists in
Schedule II of the Convention on
Psychotropic Substances of 1971. The
Committee considered that there is sufficient
evidence that UR–144 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 Committee recommended that UR–144
((1-Pentyl-1H-indol-3-yl)(2,2,3,3tetramethylcyclopropyl)methanone) be
placed in Schedule II under the Convention
on Psychotropic Substances of 1971.
daltland on DSKBBV9HB2PROD with NOTICES
5F–PB–22
Chemically, 5F–PB–22 is Quinolin-8-yl 1(5-fluoropentyl)-lH-indole-3-carboxylate. It
has no stereoisomers.
5F–PB–22 has not been previously prereviewed or critically reviewed. A direct
critical review was proposed based on
information brought to WHO’s attention that
5F–PB–22 is clandestinely manufactured, of
especially serious risk to public health and
society, and of no recognized therapeutic use
by any party.
The Committee considered that the degree
of risk to public health and society associated
with the abuse of 5F–PB–22 is substantial.
Therapeutic usefulness has not been
recorded. It recognized that 5F–PB–22 has
similar abuse and similar ill-effects to other
synthetic cannabinoids receptor agonists in
Schedule II of the Convention on
Psychotropic Substances of 1971. The
Committee considered that there is sufficient
evidence that 5F–PB–22 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 Committee recommended that
5F–PB–22 (Quinolin-8-yl 1-(5-fluoropentyl)-l
H-indole-3-carboxylate) be placed in
Schedule II under the Convention on
Psychotropic Substances of 1971.
4-Fluoroamphetamine (4–FA)
The chemical name of 4–FA is 1-(4Fluorophenyl)propan-2-amine. The presence
of a chiral centre gives rise to the
enantiomeric pair of (S)–4–FA and (R)–4–FA,
respectively. 4–FA is most likely to be
available as the racemic mixture.
4–FA underwent a critical review in 2015.
At that time, the committee recommended
that 4–FA not be placed under international
control due to insufficient evidence regarding
dependence, abuse, and risks to public
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health. However, it was kept under
surveillance. Preliminary information
collected from various sources indicated that
this substance may cause substantial harm
and that it has no medical use, thereby
warranting an updated critical review.
4–FA is a ring-substituted derivative of
amfetamine that is listed in Schedule II of the
Convention on Psychotropic Substances of
1971. The clinical features associated with 4–
FA intoxications include agitation,
tachycardia, hypertension, hyperthermia,
cardiovascular toxicity and cerebrovascular
complications such as severe headaches and
cerebral hemorrhage. Some severe adverse
reactions required hospitalizations and
others resulted in death.
The Committee considered that the degree
of risk to public health and society associated
with the abuse of 4–FA is substantial.
Therapeutic usefulness has not been
recorded. It recognized that 4–FA has similar
abuse and similar ill-effects to substances in
Schedule II of the Convention on
Psychotropic Substances of 1971.
The Committee considered that there is
sufficient evidence that 4–FA 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 Committee
recommended that 4–FA (1-(4Fluorophenyl)propan-2-amine) be placed in
Schedule II under the Convention on
Psychotropic Substances of 1971.
Substances recommended for critical
review:
Preparations Containing Almost Exclusively
Cannabidiol (CBD)
Chemically, cannabidiol is (l’R,2′R)-5′Methyl-4-pentyl-2′-(prop-1-en-2-yl)-l′,2′,3′,4′tetrahydro-[1,1′-biphenyl]-2,6-diol.
Cannabidiol (CBD) is normally taken to refer
to the naturally occurring (-)- enantiomer.
Cannabidiol has not been previously prereviewed or critically reviewed by the Expert
Committee on Drug Dependence (ECDD). The
current review was based on the
recommendation from the 38th ECDD that
pre-review documentation on cannabisrelated substances, including cannabidiol, be
prepared and evaluated at a subsequent
committee meeting.
CBD is not specifically listed in the
schedules of the 1961, 1971 or 1988
International Drug Control Conventions.
There is no evidence that CBD as a substance
is liable to similar abuse and similar illeffects as substances in the 1961 or 1971
Conventions (including cannabis and
dronabinol (THC), respectively). The purpose
of the pre-review was to determine whether
current information justifies an Expert
Committee critical review whereby the
Committee finds that information may justify
the scheduling or a change in the scheduling
of the substance in the 1961 or 1971
Conventions. As CBD is not currently a
scheduled substance in its own right (only as
a component of cannabis extracts), current
information does not justify a change in this
scheduling position and does not justify
scheduling of the substance.
However, CBD is produced for
pharmaceutical purposes as an extract of
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cannabis, and cannabis extracts and tinctures
are included in the Single Convention on
Narcotic Drugs of 1961. The pre-review of
Cannabis Extracts and Tinctures will be held
at the 40th ECDD meeting in May 2018.
Therefore it is also recommended that
extracts or preparations containing almost
exclusively CBD (cannabidiol; (l′R,2′R)-5′
Methyl-4-pentyl-2′-(prop-1-en-2-yl)-1′,2′,3′,4′tetrahydro-[1,l′-biphenyl]-2,6-diol) be subject
to critical review at that meeting.
Pregabalin
Chemically, pregabalin is (3S)-3(Aminomethyl)-5-methylhexanoic acid.
Pregabalin is the (S)-(+)-isomer of 3-isobutylGABA.
Pregabalin has not been previously prereviewed or critically reviewed. A pre-review
at the 39th ECDD was proposed based on
information received by the WHO Secretariat
regarding the misuse of pregabalin.
Pregabalin, a gabapentinoid, is an analogue
of gamma amino butyric acid (GABA), but
does not act at GABA receptors or synapses
or bind to benzodiazepine receptors. While
pregabalin has therapeutic uses, the
increasing evidence of its misuse and abuse
in many countries is becoming a growing
cause for concern.
Pregabalin has been shown to have the
capacity to produce a state of dependence.
On this basis, the Committee recommended
that pregabalin ((3S)-3-(Aminomethyl)-5methylhexanoic acid) proceed to a future
critical review. The Committee requested that
the Secretariat collect further data to support
the critical review.
Tramadol
Chemically, tramadol is rac-(1R,2R)-2[(Dimethylamino)methyl]-1-(3methoxyphenyl)cyclohexan-1-ol. Tramadol
has two chiral centres and consequently, four
different stereoisomers exist: (1R,2R), (1S,2S),
(1R,2S), and (1S,2R).
Pre-reviews of Tramadol have been carried
out by the ECDD in 1992, 2000, 2006, and
2014 and a critical review in 2002. The
Committee most recently at its 36th meeting
in 2014, and based on the evidence available
regarding dependence, abuse and risks to
public health, recommended that a critical
review of tramadol was not warranted at that
time. On the basis of information received by
the WHO Secretariat regarding the misuse of
tramadol, it was recommended that a prereview of tramadol be carried out at the 39th
ECDD in November 2017.
Tramadol is used as a medication for
controlling moderate acute and chronic
painful conditions, and it is listed in several
national essential medicines lists. It produces
opioid-like effects predominately through the
conversion of tramadol into its active
metabolite. There is growing evidence of
abuse of tramadol in many countries,
accompanied by adverse reactions, and
tramadol-associated deaths. The Committee
recommended that tramadol ((rac-(1R,2R)-2[(Dimethylamino)methyl]-1-(3methoxyphenyl)cyclohexan-1-ol) proceed to
a critical review at a subsequent meeting. The
Committee requested the Secretariat to
collect additional data for the critical review,
including engagement with Member States to
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obtain information on the extent of problems
associated with tramadol misuse. Also, the
Committee asked for information on the
medical use of tramadol including the extent
that low income countries, countries facing
conflicts and aid and relief agencies use and
possibly rely on tramadol for provision of
analgesia.
Substance recommended to remain under
surveillance:
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Etizolam (INN)
Chemically, etizolam is 4-(2Chlorophenyl)-2-ethyl-9-methyl-6Hthieno[3,2-f][1,2,4]triazolo[4,3a][l,4]diazepine. It does not have
stereoisomers.
The ECDD reviewed etizolam at the 26th
meeting (1989) and the 27th meeting (1990).
At the 37th ECDD in 2015, the committee
pre-reviewed etizolam and recommended
that a critical review of etizolam was
warranted for a future meeting. The
Committee noted deficiencies in information
and suggested several potential sources that
could be helpful in the preparation of the
critical review, including those from traffic
accident reports, seizure data, user forums,
and pharmacovigilance data.
Owing to the lack of significantly more
information since the pre-review conducted
by the 37th ECDD in 2015, and considering
the current insufficiency of data regarding
dependence, abuse and risks to public health,
the Committee recommended that etizolam
(4-(2-Chlorophenyl)-2-ethyl-9-methyl-6Hthieno[3,2-f] [1,2,4]triazolo[4,3a][l,4]diazepine) be kept under surveillance.
The Committee asked the Secretariat to
request more data from Member States that
may be affected by the misuse of etizolam,
and which could facilitate a future review.
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.
Carfentanil, also known as 4carbomethoxyfentanyl, is an extremely
potent synthetic opioid that is similar in
structure to and approximately 100
times more potent than fentanyl as an
analgesic. At one time legitimately
produced, carfentanil is no longer
manufactured, marketed, or used in the
United States; it is approved by FDA for
use under restricted conditions by
veterinarians as an immobilizing agent
for certain large animals. Illicitly
produced carfentanil is a particularly
harmful fentanyl analogue that is also
being laced into heroin or sold by itself
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and trafficked in the United States. It is
not approved for human use. Drug
seizure data indicate that carfentanil is
typically used in small doses to cut
heroin and other illicitly abused drugs.
The significant risk to public health
associated with carfentanil use stems
from its respiratory depressive effects
with very small amounts. Several
fatalities have been reported as the
result of carfentanil overdoses. On
October 28, 1988, the Drug Enforcement
Administration (DEA) published a Final
Rule that placed carfentanil in Schedule
II of the CSA (53 FR 43684). As such,
no additional controls will be necessary
to fulfill U.S. obligations if carfentanil is
placed in Schedules I and IV of the
Single Convention on Narcotic Drugs
(1961).
Ocfentanil is a synthetically produced
opioid that is structurally related to
fentanyl and approximately equipotent
in effect. Reported risks associated with
use of ocfentanil include development
of opioid use disorder, overdose, and
fatal overdose. It has no approved
medical use in the United States. The
DEA initiated the temporary placement
of this substance under Schedule I by
publishing a notification of intent in the
Federal Register on December 13, 2017
(82 FR 58575). As such, additional
controls will be necessary to fulfill U.S.
obligations if ocfentanil is placed in
Schedules I of the Single Convention on
Narcotic Drugs (1961).
Furanyl fentanyl (Fu-F) is a potent
clandestinely produced synthetic opioid
that is an analog of fentanyl. Evidence
suggests that the pattern of abuse of
fentanyl analogues, including furanyl
fentanyl, parallels that of heroin and
prescription opioid analgesics. Fu-F
produces typical opioid effects that
include respiratory depression and loss
of consciousness. Seizures of Fu-F have
been encountered in powder form. FuF has been connected to fatal overdoses,
in which intravenous routes of
administration are documented. It has
no approved medical use in the United
States. On November 29, 2016, the DEA
issued a final order to temporarily
schedule Fu-F and its isomers, esters,
ethers, salts and salts of isomers, esters
and ethers into Schedule I pursuant to
the temporary scheduling provisions of
the CSA (81 FR 85873). As such,
additional permanent controls will be
necessary to fulfill U.S. obligations if
Fu-F is controlled under Schedule I of
the 1961 Single Convention.
Acryloylfentanyl (Acryl fentanyl)
belongs to the 4-anilidopiperidine class
of synthetic opioids and is similar in
structure to fentanyl. Acryloylfentanyl
is a clandestinely produced analog of
fentanyl and sold illegally as a research
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3747
chemical on several websites.
Acryloylfentanyl has also been
associated with adverse events typically
associated with opioid use such as
respiratory depression, anxiety,
constipation, tiredness, hallucinations,
and withdrawal. The use of
acryloylfentanyl has also been linked to
the development of opioid use disorder,
overdose, and fatal overdose.
Acryloylfentanyl has no commercial
or medical uses. On July 14, 2017, the
DEA issued a temporary order to
temporarily schedule acryloylfentanyl,
its isomers, esters, ethers, salts and salts
of isomers, esters and ethers into
Schedule I pursuant to the temporary
scheduling provisions of the CSA (82 FR
32453). As such, additional permanent
controls will be necessary to fulfill U.S.
obligations if Fu-F is controlled under
Schedule I of the 1961 Single
Convention.
4-fluoroisobutyryl fentanyl (4–FIBF)
is a clandestinely produced synthetic
opioid that is an analog of fentanyl. It
has m-receptor agonist activity similar
to that of fentanyl. This would result in
effects associated with opioid agonists
such as analgesia, respiratory
depression, anxiety, constipation,
tiredness, hallucinations, withdrawal,
development of opioid use disorder,
overdose, and fatal overdose. The use of
4–FIBF has been implicated in several
cases of overdose and fatal overdoses.
4–FIBF has not been approved for
medical use in the United States. On
May 3, 2017, the DEA issued a
temporary order to temporarily schedule
4–FIBF, its isomers, esters, ethers, salts
and salts of isomers, esters and ethers
into Schedule I pursuant to the
temporary scheduling provisions of the
CSA (82 FR 20544). As such, additional
permanent controls will be necessary to
fulfill U.S. obligations if 4–FIBF is
controlled under Schedule I of the 1961
Single Convention.
AB–CHMINACA is a clandestinely
produced synthetic cannabinoid agonist
that is approximately 16 times more
potent than delta-9tetrahydrocannabinol. Adverse effects
produced by cannabinoid agonists
include tachycardia, agitation,
hallucination, chest pain, seizure, organ
failure, anxiety, acute psychosis, and
death. AB–CHMINACA has been
detected in illicit synthetic cannabinoid
substances and found in cases of
overdose and hospitalizations. On
October 16, 2017, the DEA published a
Final Rule to permanently control AB–
CHMINACA as a Schedule I substance
under the CSA (82 FR 47971). As such,
additional permanent controls will be
not necessary to fulfill U.S. obligations
if AB–CHMINACA is controlled under
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Federal Register / Vol. 83, No. 18 / Friday, January 26, 2018 / Notices
Schedule I of the 1961 Single
Convention.
5F–ADB is a clandestinely produced
synthetic cannabinoid agonist. In
general, adverse effects produced by
cannabinoid agonists include
tachycardia, agitation, hallucination,
chest pain, seizure, anxiety, and acute
psychosis. 5F–ADB has been identified
in overdose and/or cases involving
death attributed to their abuse. Adverse
health effects reported from incidents
involving 5F–ADB and other synthetic
cannabinoids have included: nausea,
persistent vomiting, agitation, altered
mental status, seizures, convulsions,
loss of consciousness, and/or cardio
toxicity. On April 10, 2017, the DEA
issued a temporary scheduling order to
temporarily schedule 5F–ADB, its
isomers, esters, ethers, salts and salts of
isomers, esters, and ethers into
Schedule I pursuant to the temporary
scheduling provisions of the CSA (82 FR
17119). As such, additional permanent
controls will be necessary to fulfill U.S.
obligations if 5F–ADB is controlled
under Schedule II of the 1971
Convention on Psychotropic
Substances.
AB–PINACA is a clandestinely
produced synthetic cannabinoid agonist
approximately 1.5 times as potent as
delta-9-tetrahydrocannabinol. Adverse
effects produced by cannabinoid
agonists include tachycardia, agitation,
hallucination, chest pain, seizure,
anxiety, acute psychosis, and death.
AB–PINACA has been detected in illicit
synthetic cannabinoid substances, and
reported in cases of overdose and
hospitalizations. It has not been
approved for medical use in the United
States. On October 16, 2017, the DEA
published a Final Rule to permanently
control AB–PINACA as a Schedule I
substance under the CSA (82 FR 47971).
As such, additional permanent controls
will not be necessary to fulfill U.S.
obligations if AB–PINACA is controlled
under Schedule II of the 1971
Convention on Psychotropic
Substances.
UR–144 is a clandestinely produced
synthetic cannabinoid agonist. In
general, adverse effects produced by
cannabinoid agonists include
tachycardia, agitation, hallucination,
chest pain, seizure, anxiety, acute
psychosis, and death. UR–144 has been
detected in herbal smoking blends that
are sold as herbal incense. On May 11,
2016, the DEA issued a Final Rule to
permanently schedule UR–144 into
Schedule I of the CSA (81 FR 29142). As
such, additional permanent controls
will not be necessary to fulfill U.S.
obligations if UR–144 is controlled
under Schedule II of the 1971
VerDate Sep<11>2014
20:14 Jan 25, 2018
Jkt 244001
Convention on Psychotropic
Substances.
5F–PB–22 is a synthetic cannabinoid
agonist with similar effects to delta-9tetrahydrocannabinol, one of the main
psychoactive components of cannabis.
Adverse effects produced by
cannabinoid agonists include
tachycardia, agitation, hallucination,
chest pain, seizure, anxiety, acute
psychosis, and death. 5F–PB–22 is
clandestinely produced. It has been
found laced on plant material and
marketed as herbal products, and is
smoked for its psychoactive effects.
According to the WHO, 5F–PB–22 has
been associated with fatal intoxications.
On September 6, 2016, the DEA issued
a Final Rule to permanently place 5F–
PB–22 into Schedule I of the CSA (81
FR 61130). As such, additional
permanent controls will not be
necessary to fulfill U.S. obligations if
5F–PB–22 is controlled under Schedule
II of the 1971 Convention on
Psychotropic Substances.
4-Fluoroamphetamine (4–FA) is a
psychoactive substance of the
phenethylamine and substituted
amphetamine chemical classes and
produces stimulant effects. WHO
reports that 4–FA is clandestinely
produced, and its use is associated with
fatal and non-fatal intoxications. 4–FA
is not approved for medical use in the
United States and it is not controlled
under the CSA. As such, additional
permanent controls will be necessary to
fulfill U.S. obligations if 4–FA is
controlled under Schedule II of the 1971
Convention on Psychotropic
Substances.
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 2018.
Comments regarding the WHO
recommendations for control of
carfentanil, ocfentanil, furanyl fentanyl
(Fu-F), acryloylfentanyl (acryl fentanyl),
4-fluoroisobutyryl fentanyl (4–FIBF),
and tetrahydrofuranylfentanyl (THF–F),
under the 1961 Single Convention, will
also be forwarded to the relevant
Agencies for consideration in
PO 00000
Frm 00076
Fmt 4703
Sfmt 4703
developing the U.S. position regarding
narcotic substances at the CND meeting.
Dated: January 23, 2018.
Leslie Kux,
Associate Commissioner for Policy.
[FR Doc. 2018–01471 Filed 1–25–18; 8:45 am]
BILLING CODE 4164–01–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Final Effect of Designation of a Class
of Employees for Addition to the
Special Exposure Cohort
National Institute for
Occupational Safety and Health
(NIOSH), Centers for Disease Control
and Prevention, Department of Health
and Human Services (HHS).
AGENCY:
ACTION:
Notice.
HHS gives notice concerning
the final effect of the HHS decision to
designate a class of employees from the
Idaho National Laboratory in Scoville,
Idaho, as an addition to the Special
Exposure Cohort (SEC) under the Energy
Employees Occupational Illness
Compensation Program Act of 2000.
SUMMARY:
FOR FURTHER INFORMATION CONTACT:
Stuart L. Hinnefeld, Director, Division
of Compensation Analysis and Support,
NIOSH, 1090 Tusculum Avenue, MS C–
46, Cincinnati, OH 45226–1938,
Telephone 877–222–7570. Information
requests can also be submitted by email
to DCAS@CDC.GOV.
SUPPLEMENTARY INFORMATION:
Authority: 42 U.S.C. 7384q(b). 42 U.S.C.
7384l(14)(C).
On November 22, 2017, as provided
for under 42 U.S.C. 7384l(14)(C), the
Acting Secretary of HHS designated the
following class of employees as an
addition to the SEC:
All employees of the Department of
Energy, its predecessor agencies, and their
contractors and subcontractors who worked
at the Idaho National Laboratory (INL) in
Scoville, Idaho, and who were monitored for
external radiation at the Idaho Chemical
Processing Plant (CPP) (e.g., at least one film
badge or TLD dosimeter from CPP) between
January 1, 1975, and December 31, 1980, for
a number of work days aggregating at least
250 work days, occurring solely under this
employment, or in combination with work
days within the parameters established for
one or more other classes of employees in the
Special Exposure Cohort.
This designation became effective on
December 22, 2017. Therefore,
beginning on December 22, 2017,
members of this class of employees,
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[Federal Register Volume 83, Number 18 (Friday, January 26, 2018)]
[Notices]
[Pages 3741-3748]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2018-01471]
-----------------------------------------------------------------------
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA-2018-N-0181]
International Drug Scheduling; Convention on Psychotropic
Substances; Single Convention on Narcotic Drugs; World Health
Organization; Scheduling Recommendations; Carfentanil; 4-
fluoroamphetamine (4-FA) and Ten Other Substances; Request for Comments
AGENCY: Food and Drug Administration, HHS.
ACTION: Notice; request for comments.
-----------------------------------------------------------------------
SUMMARY: The Food and Drug 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 distributing restrictions, under
international treaties, on certain drug substances. The comments
received in response to this notice 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
2018. This notice is issued under the Controlled Substances Act (CSA).
DATES: Submit either electronic or written comments by February 26,
2018.
ADDRESSES: You may submit comments as follows. Please note that late,
untimely filed comments will not be considered. Electronic comments
must be submitted on or before February 26, 2018. The https://www.regulations.gov electronic filing system will accept comments until
midnight Eastern Time at the end of February 26, 2018. Comments
received by mail/hand delivery/courier (for written/paper submissions)
will be considered timely if they are postmarked or the delivery
[[Page 3742]]
service acceptance receipt is on or before that date.
Electronic Submissions
Submit electronic comments in the following way:
Federal eRulemaking Portal: https://www.regulations.gov.
Follow the instructions for submitting comments. Comments submitted
electronically, including attachments, to https://www.regulations.gov
will be posted to the docket unchanged. Because your comment will be
made public, you are solely responsible for ensuring that your comment
does not include any confidential information that you or a third party
may not wish to be posted, such as medical information, your or anyone
else's Social Security number, or confidential business information,
such as a manufacturing process. Please note that if you include your
name, contact information, or other information that identifies you in
the body of your comments, that information will be posted on https://www.regulations.gov.
If you want to submit a comment with confidential
information that you do not wish to be made available to the public,
submit the comment as a written/paper submission and in the manner
detailed (see ``Written/Paper Submissions'' and ``Instructions'').
Written/Paper Submissions
Submit written/paper submissions as follows:
Mail/Hand delivery/Courier (for written/paper
submissions): Dockets Management Staff (HFA-305), Food and Drug
Administration, 5630 Fishers Lane, Rm. 1061, Rockville, MD 20852.
For written/paper comments submitted to the Dockets
Management Staff, FDA will post your comment, as well as any
attachments, except for information submitted, marked and identified,
as confidential, if submitted as detailed in ``Instructions.''
Instructions: All submissions received must include the Docket No.
FDA-2018-N-0181 for ``International Drug Scheduling; Convention on
Psychotropic Substances; Single Convention on Narcotic Drugs; World
Health Organization; Scheduling Recommendations; Carfentanil; 4-
fluoroamphetamine (4-FA) and Ten Other Substances; Request for
Comments.'' Received comments, those filed in a timely manner (see
ADDRESSES), will be placed in the docket and, except for those
submitted as ``Confidential Submissions,'' publicly viewable at https://www.regulations.gov or at the Dockets Management Staff between 9 a.m.
and 4 p.m., Monday through Friday.
Confidential Submissions--To submit a comment with
confidential information that you do not wish to be made publicly
available, submit your comments only as a written/paper submission. You
should submit two copies total. One copy will include the information
you claim to be confidential with a heading or cover note that states
``THIS DOCUMENT CONTAINS CONFIDENTIAL INFORMATION.'' The Agency will
review this copy, including the claimed confidential information, in
its consideration of comments. The second copy, which will have the
claimed confidential information redacted/blacked out, will be
available for public viewing and posted on https://www.regulations.gov.
Submit both copies to the Dockets Management Staff. If you do not wish
your name and contact information to be made publicly available, you
can provide this information on the cover sheet and not in the body of
your comments and you must identify this information as
``confidential.'' Any information marked as ``confidential'' will not
be disclosed except in accordance with 21 CFR 10.20 and other
applicable disclosure law. For more information about FDA's posting of
comments to public dockets, see 80 FR 56469, September 18, 2015, or
access the information at: https://www.gpo.gov/fdsys/pkg/FR-2015-09-18/pdf/2015-23389.pdf.
Docket: For access to the docket to read background documents or
the electronic and written/paper comments received, go to https://www.regulations.gov and insert the docket number, found in brackets in
the heading of this document, into the ``Search'' box and follow the
prompts and/or go to the Dockets Management Staff, 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, [email protected].
SUPPLEMENTARY INFORMATION:
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 six substances to be considered for
control under the Psychotropic Convention. This notification reflects
the recommendation from the 39th WHO Expert Committee for Drug
Dependence (ECDD), which met in November 2017. In the Federal Register
of August 14, 2017 (82 FR 37866), 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 six
substances 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, to provide interested and affected
persons an opportunity to submit comments regarding the WHO
recommendations for narcotic drugs, the notification regarding these
substances 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 these substances. The HHS recommendations are not
binding on the representative of the United States in discussions and
negotiations relating to
[[Page 3743]]
the proposal regarding control of substances under the 1961 Single
Convention.
The short 30-day time period for the submission of comments is
needed to ensure that Health and Human Services may, in a timely
fashion, carry out the required action and be responsive to the United
Nations.
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 (non-relevant text removed):
Reference:
NAR/CL.4/2017
WHO/ECDD39; 1961C-Art.3; 1971C-Art.2
CU 2017/437/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 1 and 4 of the Convention on Psychotropic
Substances of 1971 (1971 Convention) notified the Secretary-General
of the following recommendations:
Substances recommended to be placed in Schedules I and IV of the
Single Convention on Narcotic Drugs (1961), as amended by the 1972
Protocol:
Carfentanil
Chemical name: Methyl 1-(2-phenylethyl)- 4-[phenyl(propanoyl)
amino]piperidine- 4-carboxylate
Substances recommended to be placed in Schedule I of the Single
Convention on Narcotic Drugs (1961), as amended by the 1972
Protocol:
Ocfentanil
Chemical name: N-(2-Fluorophenyl)-2-methoxy-N-[1-(2-
phenylethyl)piperidin-4-yl]acetamide
Furanyl fentanyl
Chemical name: N-Phenyl-N-[1-(2-phenylethyl)piperidin-4-
yl]furan-2-carboxamide
Acryloylfentanyl (Acryl fentanyl)
Chemical name: N-Phenyl-N-[1-(2-phenylethyl)piperidin-4-yl]prop-
2-enamide
4-Fluoroisobutyryl fentanyl (4-FIBF, pFIBF)
Chemical name: N-(4-Fluorophenyl)-2-methyl-N-[1-(2-
phenylethyl)piperidin-4-yl]propanamide
Tetrahydrofuranylfentanyl (THF-F)
Chemical name: N-Phenyl-N-[1-(2-phenylethyl)piperidin-4-
yl]oxolane-2-carboxamide
Substances recommended to be placed in Schedule II of the
Convention on Psychotropic Substances (1971):
AB-CHMINACA
Chemical name: N-[(2S)-1-Amino-3-methyl-1-oxobutan-2-yl]-1-
(cyclohexylmethyl)-1H-indazole-3-carboxamide
5F-ADB (5F-MDMB-PINACA)
Chemical name: Methyl (2S)-2-{[1-(5-fluoropentyl)-1H-indazole-3-
carbonyl]amino{time} -3,3-dimethylbutanoate
AB-PINACA
Chemical name: N-[(2S)-1-Amino-3-methyl-1-oxobutan-2-yl]-1-
pentyl-1H-indazole-3-carboxamide
UR-144
Chemical name: (1-Pentyl-1H-indol-3-yl)(2,2,3,3-
tetramethylcyclopropyl)methanone
5F-PB-22
Chemical name: Quinolin-8-yl 1-(5-fluoropentyl)-1H-indole-3-
carboxylate
4-Fluoroamphetamine (4-FA)
Chemical name: 1-(4-Fluorophenyl)propan-2-amine
In addition, in the letter from the Director-General of the
World Health Organization to the Secretary-General, reference is
also made to the recommendations by the thirty-ninth meeting of the
WHO Expert Committee on Drug Dependence (ECDD) for carrying out a
critical review of preparations containing almost exclusively
cannabidiol (CBD), Pregabalin, and Tramadol at a subsequent Expert
Committee meeting, as well as for Etizolam to remain under
surveillance. Furthermore, the letter also makes reference to the
recommendation by the Expert Committee with regard to cannabis and
its component substances.
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 sixty-first session of the Commission on Narcotic
Drugs (12-16 March 2018).
In connection with the notification, WHO has also submitted the
relevant extract from the report of the thirty-ninth meeting of the
WHO Expert Committee on Drug Dependence which is hereby transmitted
as Annex II.
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 that are recommended by WHO to be placed under
international control under the 1961 Convention (namely:
Carfentanil, Ocfentanil, Furanyl fentanyl, Acryloylfentanyl (Acryl
fentanyl), 4-Fluoroisobutyryl fentanyl (4-FIBF, pFIBF), and
Tetrahydrofuranylfentanyl (THF-F)) and the 1971 Convention (namely:
AB CHMINACA, 5F-ADB (5F-MDMB-PINACA), AB-PINACA, UR-144, 5F-PB-22
and 4-Fluoroamphetamine (4-FA)).
Communications are to be sent at the latest by 2 February 2018
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, e-mail: [email protected].
28 December 2017
His Excellency
Mr. Rex Tillerson
Secretary of State of the United States of America
Annex I
Letter Addressed to the Secretary-General of the United Nations From
the Director-General of the World Health Organization
``The Thirty-Ninth meeting of the WHO Expert Committee on Drug
Dependence convened from 6 to 10 November 2017, at WHO headquarters
in Geneva. The objective of this meeting was to carry out an in-
depth evaluation of psychoactive substances in order to determine
whether or not WHO should recommend these substances to be placed
under international control.
With reference to Article 2, paragraphs 1 and 4 of the
Convention on Psychotropic Substances (1971) and Article 3,
paragraphs 1 and 3 of the Single Convention on Narcotic Drugs
(1961), as amended by the 1972 Protocol, I am pleased to submit
recommendations of the World Health Organization as follows:
To be placed in Schedules I and IV of the Single Convention on
Narcotic Drugs (1961):
--Carfentanil
chemical name: Methyl 1-(2-phenylethyl)-4- [phenyl(propionoyl)
amino]piperidine-4-carboxylate
To be placed in Schedule I of the Single Convention on Narcotic
Drugs (1961):
--Ocfentanil
chemical name: N-(2-Fluorophenyl)-2-methoxy-N-[1-(2-
phenylethyl)piperidin-4-yl]acetamide
--Furanyl fentanyl
chemical name: N-Phenyl-N-[1-(2-phenylethyl)piperidin-4-
yl]furan-2-carboxamide
--Acryloylfentanyl (Acryl fentanyl)
chemical name: N-Phenyl-N-[1-(2-phenylethyl)piperidin-4-yl]prop-
2-enamide
--4-Fluoroisobutyryl fentanyl (4-FIBF, pFIBF)
chemical name: N-(4-Fluorophenyl)-2-methyl-N-[1-(2-
phenylethyl)piperidin-4-yl]propanamide
--Tetrahydrofuranylfentanyl (THF-F)
chemical name: N-Phenyl-N-[1-(2-phenylethyl)piperidin-4-
yl]oxolane-2-carboxamide
To be placed in Schedule II of the Convention on Psychotropic
Substances (1971):
--AB-CHMINACA
chemical name: N-[(2S)-1-Amino-3-methyl-1-oxobutan-2-yl]-1-
(cyclohexylmethyl)-lH-indazole-3-carboxamide
--5F-ADB (5F-MDMB-PINACA)
chemical name: Methyl (2S)-2-{[l-(5-fluoropentyl)-1H-indazole-3-
carbonyl] amino{time} -3,3-dimethylbutanoate
--AB-PINACA
chemical name: N-[(2S)-1-Amino-3-methyl-1-oxobutan-2-yl]-1-
pentyl-1H-indazole-3-carboxamide
--UR-144
chemical name: (1-Pentyl-1H-indol-3-yl)(2,2,3,3-
tetramethylcyclopropyl)methanone
--5F-PB-22
[[Page 3744]]
chemical name: Quinolin-8-yl 1-(5-fluoropentyl)-l H-indole-3-
carboxylate
--4-Fluoroamphetamine (4-FA)
chemical name: 1-(4-Fluorophenyl)propan-2-amine
In addition, the Expert Committee recommended to carry out a
critical review at a subsequent Expert Committee meeting for:
--Preparations containing almost exclusively cannabidiol (CBD)
chemical name: (1'R,2'R)-5'-Methyl-4-pentyl-2'-(prop-1-en-2-yl)-
1',2',3',4'-tetrahydro-[1,l'biphenyl]-2,6-diol
--Pregabalin
chemical name: (3S)-3-(Aminomethyl)-5-methylhexanoic acid
--Tramadol
chemical name: rac-(1R,2R)-2-[(Dimethylamino)methyl]-1-(3-
methoxyphenyl)cyclohexan-1-ol
It also recommended that the following substance remain under
surveillance:
--Etizolam (INN)
chemical name: 4-(2-Chlorophenyl)-2-ethyl-9-methyl-6H-
thieno[3,2:/] [1,2,4]triazolo[4,3-a][1,4]diazepine
The recommendations and the assessments and findings on which
they are based are set out in detail in the Report of the 39th
Expert Committee on Drug Dependence, which is the Committee that
advises me on these issues. An extract of the Committee's Report is
attached in Annex 1 to this letter.
I am very pleased with the ongoing collaboration among the
United Nations Office on Drugs and Crime (UNODC), International
Narcotics Control Board (INCB) and WHO, in particular, how this
collaboration has supported the work of the WHO Expert Committee on
Drug Dependence, and more generally, the implementation of
operational recommendations from the United Nations General Assembly
Special Session (UNGASS) 2016.
I would like to take this opportunity to inform you that the
40th Expert Committee on Drug Dependence will take place in May 2018
and will be specifically dedicated to the pre review of cannabis and
its major components substances.''
Annex II
Extract From the Report of the 39th Expert Committee on Drug Dependence
Substances recommended to be scheduled in Schedule I and
Schedule IV of the Single Convention on Narcotic Drugs (1961), as
amended by the 1972 Protocol:
Carfentanil
Chemically, carfentanil is Methyl 1-(2-phenylethyl)-4-
[phenyl(propionoyl)amino]piperidine-4-carboxylate. Carfentanil has
no stereoisomers.
Carfentanil has not been previously pre-reviewed or critically
reviewed. A notification was received from a Party to the
Conventions thus initiating a critical review.
Carfentanil is convertible into sufentanil and alfentanil, two
very potent opioid analgesics controlled as Schedule I drugs under
the Single Convention on Narcotic Drugs of 1961. It is a [micro]-
opioid receptor agonist, and its pharmacodynamic and clinical
effects are similar to fentanyl but it is about 100 times more
potent. It binds to opioid receptors, and produces respiratory
depression, decreased consciousness, antinociception, and miosis.
The substance has been associated with hundreds of deaths and
nonfatal intoxications globally, and it has created significant
concerns in a number of countries. Due to the extremely small doses
that induce lethal effects, it poses a particularly serious threat
to public health.
Carfentanil is a compound liable to similar abuse and with
similar ill effects to controlled opioids such as fentanyl that are
included in Schedule I of the Single Convention on Narcotic Drugs of
1961. There is sufficient evidence that it 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.
Thus, because it meets the required condition of similarity, it is
recommended that carfentanil (Methyl 1-(2-phenylethyl)-4-
[phenyl(propionoyl)amino]piperidine-4-carboxylate) be placed in
Schedule I of the Single Convention on Narcotic Drugs of 1961, as
consistent with Article 3, paragraph 3 (iii) of that Convention in
that the substance is liable to similar abuse and productive of
similar ill effects to drugs in Schedule I.
The Committee considered and recognized the impact that
international scheduling could have on veterinary access to
carfentanil in relation to its therapeutic use in large animals.
However, the Committee was particularly concerned regarding the
extreme potency of the substance and serious risk to public health.
The Committee felt that the therapeutic advantages did not offset
the severe threat to human health. As such, and with consideration
that substances in Schedule IV afford Parties the opportunity to
adopt special measures for drugs with particularly dangerous
properties, the Committee recommended that carfentanil (Methyl 1-(2-
phenylethyl)-4-[phenyl(propionoyl)amino]piperidine-4-carboxylate) be
also placed in Schedule IV of the Single Convention on Narcotic
Drugs of 1961.
Substances recommended to be placed in Schedule I of the Single
Convention on Narcotic Drugs (1961), as amended by the 1972
Protocol:
Ocfentanil
Chemically, ocfentanil is N-(2-Fluorophenyl)-2-methoxy-N-[1-(2-
phenylethyl)piperidin-4-yl]acetamide. It has no stereoisomers.
Ocfentanil has not been previously pre-reviewed or critically
reviewed. A direct critical review was proposed based on information
brought to the attention of WHO that ocfentanil is clandestinely
manufactured, poses a risk to public health and society, and has no
recognized therapeutic use by any party.
Ocfentanil is an opioid that is structurally related to fentanyl
that is regulated under Schedule I of the Single Convention on
Narcotic Drugs of 1961, and produces opioid effects including
analgesia, euphoria, sedation, and potentially serious respiratory
depression. Ocfentanil-related deaths have been reported, and it has
come under national control in several countries in different
regions of the world.
Ocfentanil is a compound liable to similar abuse and with
similar ill effects to controlled opioids such as fentanyl that are
included in Schedule I of the Single Convention on Narcotic Drugs of
1961. It has no recorded therapeutic use, and its use has been
associated with fatalities. There is sufficient evidence that it 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. Thus, because it meets the required condition
of similarity, it is recommended that ocfentanil (N-(2-
Fluorophenyl)-2-methoxy-N-[1-(2-phenylethyl)piperidin-4-
yl]acetamide) be placed in Schedule I of the Single Convention on
Narcotic Drugs of 1961, as consistent with Article 3, paragraph 3
(iii) of that Convention in that the substance is liable to similar
abuse and productive of similar ill effects to drugs in Schedule I.
Furanyl fentanyl
Chemically, furanyl fentanyl is N-Phenyl-N-[1-(2-
phenylethyl)piperidin-4-yl]furan-2-carboxamide. Furanyl fentanyl has
no stereoisomers.
Furanyl fentanyl has not been previously pre-reviewed or
critically reviewed. A direct critical review was proposed based on
information brought to WHO's attention that furanyl fentanyl is
clandestinely manufactured, of especially serious risk to public
health and society, and of no recognized therapeutic use by any
party.
Furanyl fentanyl is a compound liable to similar abuse and with
similar ill effects to controlled opioids such as fentanyl that are
included in Schedule I of the Single Convention on Narcotic Drugs of
1961. It has no recorded therapeutic use and its use has been
associated with fatalities. There is sufficient evidence that it 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. Thus, because it meets the required condition
of similarity, it is recommended that furanyl fentanyl (N-Phenyl-N-
[1-(2-phenylethyl)piperidin-4-yl]furan-2-carboxamide) be placed in
Schedule I of the Single Convention on Narcotic Drugs of 1961, as
consistent with Article 3, paragraph 3 (iii) of that Convention in
that the substance is liable to similar abuse and productive of
similar ill effects to drugs in Schedule I.
Acryloylfentanyl (Acryl fentanyl)
Chemically, acryloylfentanyl is N-Phenyl-N-[1-(2-
phenylethyl)piperidin-4-yl]prop-2-enamide. It has no stereoisomers.
Acryloylfentanyl has not been previously pre-reviewed or
critically reviewed. A direct critical review was proposed based on
information brought to WHO's attention that acryloylfentanyl is
clandestinely manufactured, of especially serious risk to public
health and society, and of no recognized therapeutic use by any
party.
Acryloylfentanyl is a compound liable to similar abuse and with
similar ill effects to
[[Page 3745]]
controlled opioids such as fentanyl that are included in Schedule I
of the Single Convention on Narcotic Drugs of 1961. It has no
recorded therapeutic use, and its use has been associated with
fatalities. There is sufficient evidence that it 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. Thus, because it meets the required condition of
similarity, it is recommended that acryloylfentanyl (N-Phenyl-N-[1-
(2-phenylethyl)piperidin-4-yl]prop-2-enamide) be placed in Schedule
I of the Single Convention on Narcotic Drugs of 1961, as consistent
with Article 3, paragraph 3 (iii) of that Convention in that the
substance is liable to similar abuse and productive of similar ill
effects to drugs in Schedule I.
4-Fluoroisobutyryl fentanyl (4-FIBF, pFIBF)
Chemically, 4-fluoroisobutyryl fentanyl (4-FIBF, pFIBF) is N-(4-
Fluorophenyl)-2-methyl-N-[1-(2-phenylethyl)piperidin-4-
yl]propanamide.
4-Fluoroisobutyryl fentanyl has not been previously pre-reviewed
or critically reviewed. A direct critical review was proposed based
on information brought to WHO's attention that it is clandestinely
manufactured, of especially serious risk to public health and
society, and of no recognized therapeutic use by any party.
4-Fluoroisobutyryl fentanyl is a compound liable to similar
abuse and with similar ill effects to controlled opioids such as
fentanyl that are included in Schedule I of the Single Convention on
Narcotic Drugs of 1961. It has no recorded therapeutic use, and its
use has been associated with fatalities. There is sufficient
evidence that it 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. Thus, because it meets
the required condition of similarity, it is recommended that 4-
fluoroisobutyryl fentanyl (N-(4-Fluorophenyl)-2-methyl-N-[l-(2-
phenylethyl)piperidin-4-yl]propanamide) be placed in Schedule I of
the Single Convention on Narcotic Drugs of 1961, as consistent with
Article 3, paragraph 3 (iii) of that Convention in that the
substance is liable to similar abuse and productive of similar ill
effects to drugs in Schedule I.
Tetrahydrofuranylfentanyl (THF-F)
Chemically, tetrahydrofuranylfentanyl is N-Phenyl-N-[1-(2-
phenylethyl)piperidin-4-yl]oxolane-2-carboxamide.
Tetrahydrofuranylfentanyl contains a stereogenic centre allowing for
the existence of a pair of enantiomers, (S)-
tetrahydrofuranylfentanyl and (R)-tetrahydrofuranylfentanyl. There
is no information on the actual enantiomers found on the illicit
drug market at the time of the report.
Tetrahydrofuranylfentanyl has not been previously pre-reviewed
or critically reviewed. A direct critical review was proposed based
on information brought to WHO's attention that
tetrahydrofuranylfentanyl is clandestinely manufactured, of
especially serious risk to public health and society, and of no
recognized therapeutic use by any party.
Tetrahydrofuranylfentanyl is a compound liable to similar abuse
and with similar ill effects to controlled opioids such as fentanyl
that are included in Schedule I of the Single Convention on Narcotic
Drugs of 1961. It has no recorded therapeutic use, and its use has
been associated with fatalities. There is sufficient evidence that
it 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. Thus, because it meets the required
condition of similarity, it is recommended that
tetrahydrofuranylfentanyl (N-Phenyl-N-[1-(2-phenylethyl)piperidin-4-
yl]oxolane-2-carboxamide) be placed in Schedule I of the Single
Convention on Narcotic Drugs of 1961, as consistent with Article 3,
paragraph 3 (iii) of that Convention in that the substance is liable
to similar abuse and productive of similar ill effects to drugs in
Schedule I.
Substances recommended to be scheduled in Schedule II of the
Convention on Psychotropic Substances (1971):
AB-CHMINACA
Chemically, AB-CHMINACA is N-[(2S)-l-Amino-3-methyl-1-oxobutan-
2-yl]-1-(cyclohexylmethyl)-lHindazole-3-carboxamide. AB-CHMINACA
contains a chiral centre, so that two enantiomers exist: (R)-
ABCHMINACA and (S)-AB-CHMINACA. Based on the literature and the most
likely precursors to be used in manufacture, an (S)-configuration of
the stereocenter should be expected.
AB-CHMINACA has not been previously pre-reviewed or critically
reviewed. A direct critical review was proposed based on information
brought to WHO's attention that AB-CHMINACA is clandestinely
manufactured, of especially serious risk to public health and
society, and of no recognized therapeutic use by any party.
AB-CHMINACA is a synthetic cannabinoid receptor agonist. It is
clandestinely manufactured and sold under a variety of brand names.
Its mode of action suggests also the potential for dependence and
likelihood of misuse. Effects of AB-CHMINACA are consistent with
those of synthetic cannabinoid receptor agonists and include
relaxation, euphoria, depersonalization, distorted perception of
time, impaired motor performance, hallucinations, paranoia,
confusion, fear, anxiety, tachycardia, and nausea and vomiting. Its
cannabimimetic effects are more potent than those of THC, which is
listed in Schedule II in the Convention on Psychotropic Substances
of 1971. There is evidence of an increase in number of persons using
AB-CHMINACA in many countries that have included fatal and non-fatal
cases. This substance causes substantial harm and has no therapeutic
usefulness. AB-CHMINACA has similar abuse and similar ill effects as
other synthetic cannabinoids receptor agonists already scheduled in
Schedule II of the Convention on Psychotropic Substances of 1971.
The Committee recommended that AB-CHMINACA (N-[(2S)-l-Amino-3-
methyl-1-oxobutan-2-yl]-1-(cyclohexylmethyl)-1H-indazole-3-
carboxamide) be placed in Schedule II under the Convention on
Psychotropic Substances of 1971.
5F-ADB/5F-MDMB-PINACA
Chemically, 5F-ADB (also known as 5F-MDMB-PINACA) is Methyl
(2S)-2-{[l-(5-fluoropentyl)-1Hindazole-3-carbonyl]amino{time} -3,3-
dimethylbutanoate. 5F-ADB contains a chiral centre, so that two
enantiomers exist: (R)-5F-ADB and (S)-5F-ADB.
5F-ADB has not been previously pre-reviewed or critically
reviewed. A direct critical review was proposed based on information
brought to WHO's attention that 5F-ADB is clandestinely
manufactured, of especially serious risk to public health and
society, and of no recognized therapeutic use by any party.
5F-ADB is a synthetic cannabinoid receptor agonist. It has
cannabimimetic effects that are more potent than those of THC and
MDMB-CHMICA, substances which are listed in Schedule II of the
Convention on Psychotropic Substances of 1971. Its mode of action
suggests the potential for dependence and likelihood of abuse. There
is evidence of an increase in number of persons using 5F-ADB in many
countries that have included fatal and non-fatal cases. This
substance causes substantial harm and has no therapeutic usefulness.
The Committee recommended that 5F-ADB, also known as 5F-MDMB-PINACA,
(Methyl (2S)-2-{[l-(5-fluoropentyl)-1H-indazole-3-
carbonyl]amino{time} -3,3-dimethylbutanoate) be placed in Schedule
II under the Convention on Psychotropic Substances of 1971.
AB-PINACA
Chemically, AB-PINACA is N-[(2S)-1-Amino-3-methyl-1-oxobutan-2-
yl]-1-pentyl-1H-indazole-3-carboxamide. AB-PINACA has stereoisomers.
AB-PINACA has not been previously pre-reviewed or critically
reviewed. A direct critical review was proposed based on information
brought to WHO's attention that AB-PINACA is clandestinely
manufactured, of especially serious risk to public health and
society, and of no recognized therapeutic use by any party.
The Committee considered that the degree of risk to public
health and society associated with the abuse of AB-PINACA is
substantial. Therapeutic usefulness has not been recorded. It
recognized that AB-PINACA has similar abuse and similar ill-effects
to other synthetic cannabinoids receptor agonists in Schedule II of
the Convention on Psychotropic Substances of 1971. The Committee
considered that there is sufficient evidence that AB-PINACA 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 Committee recommended that ABPINACA (N-
[(2S)-l-Amino-3-methyl-1-oxobutan-2-yl]-1-pentyl-1H -indazole-3-
carboxamide) be placed in Schedule II under the Convention on
Psychotropic Substances of 1971.
UR-144
Chemically, UR-144 is (1-Pentyl-1H-indol-3-yl)(2,2,3,3-
tetramethylcyclopropyl)methanone. It has no stereoisomers.
UR-144 was previously critically reviewed by the 36th ECDD in
2014. The Committee
[[Page 3746]]
recommended that UR-144 not be placed under international control at
that time but be kept under surveillance.
Of particular significance to the Committee was the lack of
analytically confirmed cases of non-fatal and fatal intoxications at
the time involving solely UR-144. Subsequent data collected from the
literature and from different countries indicating that this
substance may cause substantial harm and that it has no medical use,
warranted an updated critical review.
The Committee considered that the degree of risk to public
health and society associated with the abuse of UR-144 is
substantial. Therapeutic usefulness has not been recorded. It
recognized that UR-144 has similar abuse and similar ill-effects to
other synthetic cannabinoids receptor agonists in Schedule II of the
Convention on Psychotropic Substances of 1971. The Committee
considered that there is sufficient evidence that UR-144 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 Committee recommended that UR-144 ((1-
Pentyl-1H-indol-3-yl)(2,2,3,3-tetramethylcyclopropyl)methanone) be
placed in Schedule II under the Convention on Psychotropic
Substances of 1971.
5F-PB-22
Chemically, 5F-PB-22 is Quinolin-8-yl 1-(5-fluoropentyl)-lH-
indole-3-carboxylate. It has no stereoisomers.
5F-PB-22 has not been previously pre-reviewed or critically
reviewed. A direct critical review was proposed based on information
brought to WHO's attention that 5F-PB-22 is clandestinely
manufactured, of especially serious risk to public health and
society, and of no recognized therapeutic use by any party.
The Committee considered that the degree of risk to public
health and society associated with the abuse of 5F-PB-22 is
substantial. Therapeutic usefulness has not been recorded. It
recognized that 5F-PB-22 has similar abuse and similar ill-effects
to other synthetic cannabinoids receptor agonists in Schedule II of
the Convention on Psychotropic Substances of 1971. The Committee
considered that there is sufficient evidence that 5F-PB-22 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 Committee recommended that 5F-PB-22
(Quinolin-8-yl 1-(5-fluoropentyl)-l H-indole-3-carboxylate) be
placed in Schedule II under the Convention on Psychotropic
Substances of 1971.
4-Fluoroamphetamine (4-FA)
The chemical name of 4-FA is 1-(4-Fluorophenyl)propan-2-amine.
The presence of a chiral centre gives rise to the enantiomeric pair
of (S)-4-FA and (R)-4-FA, respectively. 4-FA is most likely to be
available as the racemic mixture.
4-FA underwent a critical review in 2015. At that time, the
committee recommended that 4-FA not be placed under international
control due to insufficient evidence regarding dependence, abuse,
and risks to public health. However, it was kept under surveillance.
Preliminary information collected from various sources indicated
that this substance may cause substantial harm and that it has no
medical use, thereby warranting an updated critical review.
4-FA is a ring-substituted derivative of amfetamine that is
listed in Schedule II of the Convention on Psychotropic Substances
of 1971. The clinical features associated with 4-FA intoxications
include agitation, tachycardia, hypertension, hyperthermia,
cardiovascular toxicity and cerebrovascular complications such as
severe headaches and cerebral hemorrhage. Some severe adverse
reactions required hospitalizations and others resulted in death.
The Committee considered that the degree of risk to public
health and society associated with the abuse of 4-FA is substantial.
Therapeutic usefulness has not been recorded. It recognized that 4-
FA has similar abuse and similar ill-effects to substances in
Schedule II of the Convention on Psychotropic Substances of 1971.
The Committee considered that there is sufficient evidence that
4-FA 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 Committee recommended that 4-FA (1-
(4-Fluorophenyl)propan-2-amine) be placed in Schedule II under the
Convention on Psychotropic Substances of 1971.
Substances recommended for critical review:
Preparations Containing Almost Exclusively Cannabidiol (CBD)
Chemically, cannabidiol is (l'R,2'R)-5'-Methyl-4-pentyl-2'-
(prop-1-en-2-yl)-l',2',3',4'-tetrahydro-[1,1'-biphenyl]-2,6-diol.
Cannabidiol (CBD) is normally taken to refer to the naturally
occurring (-)- enantiomer.
Cannabidiol has not been previously pre-reviewed or critically
reviewed by the Expert Committee on Drug Dependence (ECDD). The
current review was based on the recommendation from the 38th ECDD
that pre-review documentation on cannabis-related substances,
including cannabidiol, be prepared and evaluated at a subsequent
committee meeting.
CBD is not specifically listed in the schedules of the 1961,
1971 or 1988 International Drug Control Conventions. There is no
evidence that CBD as a substance is liable to similar abuse and
similar ill-effects as substances in the 1961 or 1971 Conventions
(including cannabis and dronabinol (THC), respectively). The purpose
of the pre-review was to determine whether current information
justifies an Expert Committee critical review whereby the Committee
finds that information may justify the scheduling or a change in the
scheduling of the substance in the 1961 or 1971 Conventions. As CBD
is not currently a scheduled substance in its own right (only as a
component of cannabis extracts), current information does not
justify a change in this scheduling position and does not justify
scheduling of the substance.
However, CBD is produced for pharmaceutical purposes as an
extract of cannabis, and cannabis extracts and tinctures are
included in the Single Convention on Narcotic Drugs of 1961. The
pre-review of Cannabis Extracts and Tinctures will be held at the
40th ECDD meeting in May 2018. Therefore it is also recommended that
extracts or preparations containing almost exclusively CBD
(cannabidiol; (l'R,2'R)-5' Methyl-4-pentyl-2'-(prop-1-en-2-yl)-
1',2',3',4'-tetrahydro-[1,l'-biphenyl]-2,6-diol) be subject to
critical review at that meeting.
Pregabalin
Chemically, pregabalin is (3S)-3-(Aminomethyl)-5-methylhexanoic
acid. Pregabalin is the (S)-(+)-isomer of 3-isobutyl-GABA.
Pregabalin has not been previously pre-reviewed or critically
reviewed. A pre-review at the 39th ECDD was proposed based on
information received by the WHO Secretariat regarding the misuse of
pregabalin.
Pregabalin, a gabapentinoid, is an analogue of gamma amino
butyric acid (GABA), but does not act at GABA receptors or synapses
or bind to benzodiazepine receptors. While pregabalin has
therapeutic uses, the increasing evidence of its misuse and abuse in
many countries is becoming a growing cause for concern.
Pregabalin has been shown to have the capacity to produce a
state of dependence. On this basis, the Committee recommended that
pregabalin ((3S)-3-(Aminomethyl)-5-methylhexanoic acid) proceed to a
future critical review. The Committee requested that the Secretariat
collect further data to support the critical review.
Tramadol
Chemically, tramadol is rac-(1R,2R)-2-[(Dimethylamino)methyl]-1-
(3-methoxyphenyl)cyclohexan-1-ol. Tramadol has two chiral centres
and consequently, four different stereoisomers exist: (1R,2R),
(1S,2S), (1R,2S), and (1S,2R).
Pre-reviews of Tramadol have been carried out by the ECDD in
1992, 2000, 2006, and 2014 and a critical review in 2002. The
Committee most recently at its 36th meeting in 2014, and based on
the evidence available regarding dependence, abuse and risks to
public health, recommended that a critical review of tramadol was
not warranted at that time. On the basis of information received by
the WHO Secretariat regarding the misuse of tramadol, it was
recommended that a pre-review of tramadol be carried out at the 39th
ECDD in November 2017.
Tramadol is used as a medication for controlling moderate acute
and chronic painful conditions, and it is listed in several national
essential medicines lists. It produces opioid-like effects
predominately through the conversion of tramadol into its active
metabolite. There is growing evidence of abuse of tramadol in many
countries, accompanied by adverse reactions, and tramadol-associated
deaths. The Committee recommended that tramadol ((rac-(1R,2R)-2-
[(Dimethylamino)methyl]-1-(3-methoxyphenyl)cyclohexan-1-ol) proceed
to a critical review at a subsequent meeting. The Committee
requested the Secretariat to collect additional data for the
critical review, including engagement with Member States to
[[Page 3747]]
obtain information on the extent of problems associated with
tramadol misuse. Also, the Committee asked for information on the
medical use of tramadol including the extent that low income
countries, countries facing conflicts and aid and relief agencies
use and possibly rely on tramadol for provision of analgesia.
Substance recommended to remain under surveillance:
Etizolam (INN)
Chemically, etizolam is 4-(2-Chlorophenyl)-2-ethyl-9-methyl-6H-
thieno[3,2-f][1,2,4]triazolo[4,3-a][l,4]diazepine. It does not have
stereoisomers.
The ECDD reviewed etizolam at the 26th meeting (1989) and the
27th meeting (1990). At the 37th ECDD in 2015, the committee pre-
reviewed etizolam and recommended that a critical review of etizolam
was warranted for a future meeting. The Committee noted deficiencies
in information and suggested several potential sources that could be
helpful in the preparation of the critical review, including those
from traffic accident reports, seizure data, user forums, and
pharmacovigilance data.
Owing to the lack of significantly more information since the
pre-review conducted by the 37th ECDD in 2015, and considering the
current insufficiency of data regarding dependence, abuse and risks
to public health, the Committee recommended that etizolam (4-(2-
Chlorophenyl)-2-ethyl-9-methyl-6H-thieno[3,2-f] [1,2,4]triazolo[4,3-
a][l,4]diazepine) be kept under surveillance. The Committee asked
the Secretariat to request more data from Member States that may be
affected by the misuse of etizolam, and which could facilitate a
future review.
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.
Carfentanil, also known as 4-carbomethoxyfentanyl, is an extremely
potent synthetic opioid that is similar in structure to and
approximately 100 times more potent than fentanyl as an analgesic. At
one time legitimately produced, carfentanil is no longer manufactured,
marketed, or used in the United States; it is approved by FDA for use
under restricted conditions by veterinarians as an immobilizing agent
for certain large animals. Illicitly produced carfentanil is a
particularly harmful fentanyl analogue that is also being laced into
heroin or sold by itself and trafficked in the United States. It is not
approved for human use. Drug seizure data indicate that carfentanil is
typically used in small doses to cut heroin and other illicitly abused
drugs. The significant risk to public health associated with
carfentanil use stems from its respiratory depressive effects with very
small amounts. Several fatalities have been reported as the result of
carfentanil overdoses. On October 28, 1988, the Drug Enforcement
Administration (DEA) published a Final Rule that placed carfentanil in
Schedule II of the CSA (53 FR 43684). As such, no additional controls
will be necessary to fulfill U.S. obligations if carfentanil is placed
in Schedules I and IV of the Single Convention on Narcotic Drugs
(1961).
Ocfentanil is a synthetically produced opioid that is structurally
related to fentanyl and approximately equipotent in effect. Reported
risks associated with use of ocfentanil include development of opioid
use disorder, overdose, and fatal overdose. It has no approved medical
use in the United States. The DEA initiated the temporary placement of
this substance under Schedule I by publishing a notification of intent
in the Federal Register on December 13, 2017 (82 FR 58575). As such,
additional controls will be necessary to fulfill U.S. obligations if
ocfentanil is placed in Schedules I of the Single Convention on
Narcotic Drugs (1961).
Furanyl fentanyl (Fu-F) is a potent clandestinely produced
synthetic opioid that is an analog of fentanyl. Evidence suggests that
the pattern of abuse of fentanyl analogues, including furanyl fentanyl,
parallels that of heroin and prescription opioid analgesics. Fu-F
produces typical opioid effects that include respiratory depression and
loss of consciousness. Seizures of Fu-F have been encountered in powder
form. Fu-F has been connected to fatal overdoses, in which intravenous
routes of administration are documented. It has no approved medical use
in the United States. On November 29, 2016, the DEA issued a final
order to temporarily schedule Fu-F and its isomers, esters, ethers,
salts and salts of isomers, esters and ethers into Schedule I pursuant
to the temporary scheduling provisions of the CSA (81 FR 85873). As
such, additional permanent controls will be necessary to fulfill U.S.
obligations if Fu-F is controlled under Schedule I of the 1961 Single
Convention.
Acryloylfentanyl (Acryl fentanyl) belongs to the 4-
anilidopiperidine class of synthetic opioids and is similar in
structure to fentanyl. Acryloylfentanyl is a clandestinely produced
analog of fentanyl and sold illegally as a research chemical on several
websites. Acryloylfentanyl has also been associated with adverse events
typically associated with opioid use such as respiratory depression,
anxiety, constipation, tiredness, hallucinations, and withdrawal. The
use of acryloylfentanyl has also been linked to the development of
opioid use disorder, overdose, and fatal overdose.
Acryloylfentanyl has no commercial or medical uses. On July 14,
2017, the DEA issued a temporary order to temporarily schedule
acryloylfentanyl, its isomers, esters, ethers, salts and salts of
isomers, esters and ethers into Schedule I pursuant to the temporary
scheduling provisions of the CSA (82 FR 32453). As such, additional
permanent controls will be necessary to fulfill U.S. obligations if Fu-
F is controlled under Schedule I of the 1961 Single Convention.
4-fluoroisobutyryl fentanyl (4-FIBF) is a clandestinely produced
synthetic opioid that is an analog of fentanyl. It has m-receptor
agonist activity similar to that of fentanyl. This would result in
effects associated with opioid agonists such as analgesia, respiratory
depression, anxiety, constipation, tiredness, hallucinations,
withdrawal, development of opioid use disorder, overdose, and fatal
overdose. The use of 4-FIBF has been implicated in several cases of
overdose and fatal overdoses. 4-FIBF has not been approved for medical
use in the United States. On May 3, 2017, the DEA issued a temporary
order to temporarily schedule 4-FIBF, its isomers, esters, ethers,
salts and salts of isomers, esters and ethers into Schedule I pursuant
to the temporary scheduling provisions of the CSA (82 FR 20544). As
such, additional permanent controls will be necessary to fulfill U.S.
obligations if 4-FIBF is controlled under Schedule I of the 1961 Single
Convention.
AB-CHMINACA is a clandestinely produced synthetic cannabinoid
agonist that is approximately 16 times more potent than delta-9-
tetrahydrocannabinol. Adverse effects produced by cannabinoid agonists
include tachycardia, agitation, hallucination, chest pain, seizure,
organ failure, anxiety, acute psychosis, and death. AB-CHMINACA has
been detected in illicit synthetic cannabinoid substances and found in
cases of overdose and hospitalizations. On October 16, 2017, the DEA
published a Final Rule to permanently control AB-CHMINACA as a Schedule
I substance under the CSA (82 FR 47971). As such, additional permanent
controls will be not necessary to fulfill U.S. obligations if AB-
CHMINACA is controlled under
[[Page 3748]]
Schedule I of the 1961 Single Convention.
5F-ADB is a clandestinely produced synthetic cannabinoid agonist.
In general, adverse effects produced by cannabinoid agonists include
tachycardia, agitation, hallucination, chest pain, seizure, anxiety,
and acute psychosis. 5F-ADB has been identified in overdose and/or
cases involving death attributed to their abuse. Adverse health effects
reported from incidents involving 5F-ADB and other synthetic
cannabinoids have included: nausea, persistent vomiting, agitation,
altered mental status, seizures, convulsions, loss of consciousness,
and/or cardio toxicity. On April 10, 2017, the DEA issued a temporary
scheduling order to temporarily schedule 5F-ADB, its isomers, esters,
ethers, salts and salts of isomers, esters, and ethers into Schedule I
pursuant to the temporary scheduling provisions of the CSA (82 FR
17119). As such, additional permanent controls will be necessary to
fulfill U.S. obligations if 5F-ADB is controlled under Schedule II of
the 1971 Convention on Psychotropic Substances.
AB-PINACA is a clandestinely produced synthetic cannabinoid agonist
approximately 1.5 times as potent as delta-9-tetrahydrocannabinol.
Adverse effects produced by cannabinoid agonists include tachycardia,
agitation, hallucination, chest pain, seizure, anxiety, acute
psychosis, and death. AB-PINACA has been detected in illicit synthetic
cannabinoid substances, and reported in cases of overdose and
hospitalizations. It has not been approved for medical use in the
United States. On October 16, 2017, the DEA published a Final Rule to
permanently control AB-PINACA as a Schedule I substance under the CSA
(82 FR 47971). As such, additional permanent controls will not be
necessary to fulfill U.S. obligations if AB-PINACA is controlled under
Schedule II of the 1971 Convention on Psychotropic Substances.
UR-144 is a clandestinely produced synthetic cannabinoid agonist.
In general, adverse effects produced by cannabinoid agonists include
tachycardia, agitation, hallucination, chest pain, seizure, anxiety,
acute psychosis, and death. UR-144 has been detected in herbal smoking
blends that are sold as herbal incense. On May 11, 2016, the DEA issued
a Final Rule to permanently schedule UR-144 into Schedule I of the CSA
(81 FR 29142). As such, additional permanent controls will not be
necessary to fulfill U.S. obligations if UR-144 is controlled under
Schedule II of the 1971 Convention on Psychotropic Substances.
5F-PB-22 is a synthetic cannabinoid agonist with similar effects to
delta-9-tetrahydrocannabinol, one of the main psychoactive components
of cannabis. Adverse effects produced by cannabinoid agonists include
tachycardia, agitation, hallucination, chest pain, seizure, anxiety,
acute psychosis, and death. 5F-PB-22 is clandestinely produced. It has
been found laced on plant material and marketed as herbal products, and
is smoked for its psychoactive effects. According to the WHO, 5F-PB-22
has been associated with fatal intoxications. On September 6, 2016, the
DEA issued a Final Rule to permanently place 5F-PB-22 into Schedule I
of the CSA (81 FR 61130). As such, additional permanent controls will
not be necessary to fulfill U.S. obligations if 5F-PB-22 is controlled
under Schedule II of the 1971 Convention on Psychotropic Substances.
4-Fluoroamphetamine (4-FA) is a psychoactive substance of the
phenethylamine and substituted amphetamine chemical classes and
produces stimulant effects. WHO reports that 4-FA is clandestinely
produced, and its use is associated with fatal and non-fatal
intoxications. 4-FA is not approved for medical use in the United
States and it is not controlled under the CSA. As such, additional
permanent controls will be necessary to fulfill U.S. obligations if 4-
FA is controlled under Schedule II of the 1971 Convention on
Psychotropic Substances.
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 2018.
Comments regarding the WHO recommendations for control of
carfentanil, ocfentanil, furanyl fentanyl (Fu-F), acryloylfentanyl
(acryl fentanyl), 4-fluoroisobutyryl fentanyl (4-FIBF), and
tetrahydrofuranylfentanyl (THF-F), 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.
Dated: January 23, 2018.
Leslie Kux,
Associate Commissioner for Policy.
[FR Doc. 2018-01471 Filed 1-25-18; 8:45 am]
BILLING CODE 4164-01-P
