[Federal Register Volume 83, Number 68 (Monday, April 9, 2018)]
[Notices]
[Pages 15155-15157]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2018-07225]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2018-N-1072]


International Drug Scheduling; Convention on Psychotropic 
Substances; Single Convention on Narcotic Drugs; Cannabis Plant and 
Resin; Extracts and Tinctures of Cannabis; Delta-9-
Tetrahydrocannabinol; Stereoisomers of Tetrahydrocannabinol; 
Cannabidiol; Request for Comments

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice; request for comments.

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SUMMARY: The Food and Drug Administration (FDA) is requesting 
interested persons to submit comments concerning abuse potential, 
actual abuse, medical usefulness, trafficking, and impact of scheduling 
changes on availability for medical use of five drug substances. These 
comments will be considered in preparing a response from the United 
States to the World Health Organization (WHO) regarding the abuse 
liability and diversion of these drugs. WHO will use this information 
to consider whether to recommend that certain international 
restrictions be placed on these drugs. This notice requesting comments 
is required by the Controlled Substances Act (the CSA).

DATES: Submit either electronic or written comments by April 23, 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 April 23, 2018. The https://www.regulations.gov electronic filing system will accept comments until 
midnight Eastern Time at the end of April 23, 2018. Comments received 
by mail/hand delivery/courier (for written/paper submissions) will be 
considered timely if they are postmarked or the delivery 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-1072 for ``International Drug Scheduling; Convention on 
Psychotropic Substances; Single Convention on Narcotic Drugs; Cannabis 
Plant and Resin; Extracts and Tinctures of Cannabis; Delta-9-
Tetrahydrocannabinol (THC); Stereoisomers of THC; Cannabidiol; 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

[[Page 15156]]

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: [email protected].

SUPPLEMENTARY INFORMATION: 

I. Background

    The United States is a party to the 1971 Convention on Psychotropic 
Substances (Psychotropic Convention). Article 2 of the Psychotropic 
Convention provides that if a party to the convention or WHO has 
information about a substance, which in its opinion may require 
international control or change in such control, it shall so notify the 
Secretary-General of the United Nations (the U.N. Secretary-General) 
and provide the U.N. Secretary-General with information in support of 
its opinion.
    Paragraph (d)(2)(A) of the CSA (21 U.S.C. 811) (Title II of the 
Comprehensive Drug Abuse Prevention and Control Act of 1970) provides 
that when WHO notifies the United States under Article 2 of the 
Psychotropic Convention that it has information that may justify adding 
a drug or other substances to one of the schedules of the Psychotropic 
Convention, transferring a drug or substance from one schedule to 
another, or deleting it from the schedules, the Secretary of State must 
transmit the notice to the Secretary of Health and Human Services 
(Secretary of HHS). The Secretary of HHS must then publish the notice 
in the Federal Register and provide opportunity for interested persons 
to submit comments that will be considered by HHS in its preparation of 
the scientific and medical evaluations of the drug or substance.

II. WHO Notification

    The Secretary of HHS received the following notice from WHO (non-
relevant text removed):

Ref.: C.L.2.2018

    The World Health Organization (WHO) presents its compliments to 
Member States and Associate Members and has the pleasure of 
informing that the 40th Expert Committee on Drug Dependence (ECDD) 
will meet in Geneva from 4 to 8 June 2018. The 40th ECDD will 
convene in a special session to review cannabis and cannabis-related 
substances on their potential to cause dependence, abuse and harm to 
health, and potential therapeutic applications. WHO will make 
recommendations to the UN Secretary-General on the need for and 
level of international control of these substances. Recommendations 
made from the 39th meeting can be found on the ECDD website (https://www.who.int/mason/entity/medicines/news/2017/letter-DG-39thECDDrecommendations.pdf?ua=1).
    At its 126th session in January 2010, the Executive Board 
approved the publication ``Guidance on the WHO review of 
psychoactive substances for international control'' (EB126/2010/
REC1, Annex 6) which requires the Secretariat to request relevant 
information from Ministers of Health in Member States to prepare a 
report for submission to the ECDD. For this purpose, a questionnaire 
was designed to gather information on the legitimate use, harmful 
use, status of national control and potential impact of 
international control for each substance under evaluation. Member 
States are invited to collaborate, as in the past, in this process 
by providing pertinent information as requested in the questionnaire 
and concerning substances under review.
    It would be appreciated if a person from the Ministry of Health 
could be designated as the focal point responsible for coordinating 
answers to the questionnaires. A list of focal points designated by 
Member States for the 39th ECDD in November 2017 is attached. It is 
requested that if a focal point's contact details including email 
address are to be added or amended, that Member States inform the 
Secretariat by 26 February 2018. Any additions or amendments to 
focal point designations should be emailed to 
[email protected].
    If no additions or amendments to focal point details are made by 
this date, the focal point from 2017 will be approached by the 
Secretariat for questionnaire completion. Where there is a competent 
National Authority under the International Drug Control Treaties, it 
is kindly requested that the questionnaires be completed in 
collaboration with such body.
    Once the Secretariat has received the contact details, focal 
points will be given further instructions and direct access to an 
online questionnaire. The questionnaires will be analysed by the 
Secretariat and prepared as a report that will be published on the 
ECDD website (https://www.who.int/medicines/access/controlled-substances/ecdd/en/) prior to the 40th ECDD meeting. The provisional 
agenda for the meeting will also be made available in advance on the 
ECDD website.
    Member States are also encouraged to provide any additional 
relevant information (unpublished or published) that is available on 
these substances to: [email protected]. This information will 
be an invaluable contribution to the ECDD and all submissions will 
be treated as confidential.
    The WHO takes this opportunity to renew to Member States and 
Associate Members the assurance of its highest consideration.
GENEVA, 30 January 2018

    FDA has verified the website addresses contained in the WHO notice, 
as of the date this document publishes in the Federal Register, but 
websites are subject to change over time. Access to view the WHO 
questionnaire can be found at https://www.who.int/medicines/access/controlled-substances/ecdd/en/.

III. Substances Under WHO Review

    WHO will convene in a special session to review the following 
substances: Cannabis plant and resin; extracts and tinctures of 
cannabis; delta-9-tetrahydrocannabinol (THC; stereoisomers of THC; and 
cannabidiol (CBD).
    The Committee from the 37th ECDD requested that Secretariat begin 
collecting data towards a pre-review of cannabis, cannabis resin, 
extracts, and tinctures of cannabis at a future meeting. Subsequent to 
this request, WHO commissioned two updates on the scientific literature 
for cannabis and cannabis resin, which were prepared and presented to 
the 38th ECDD. That Committee noted that the current Schedule I under 
the 1961 Convention groups together cannabis and cannabis resin, 
extracts, and tinctures of cannabis, that cannabis plant and cannabis 
resin are also in Schedule IV of the 1961 Convention, that there are 
natural and synthetic cannabinoids in Schedule I and Schedule II of the 
1971 Convention, and that cannabis had never been subject to pre-review 
or critical review by the ECDD. The Committee also noted an increase in 
the use of cannabis and its components for medical purposes and the 
emergence of new cannabis-related pharmaceutical preparations for 
therapeutic use. From this review, the 38th ECDD Committee recommended 
that preparations be made to conduct pre-reviews at a future meeting 
dedicated to the following substances: Cannabis plant and cannabis 
resin, extracts and tinctures of cannabis, THC, CBD, and stereoisomers 
of THC. An excerpt from the report of the 38th ECDD stated that the 
purpose of the pre-review was to determine whether current information 
justifies an Expert Committee critical review. They noted that the 
categories of information for evaluating substances in pre-reviews are 
identical to those used in critical reviews and that the pre-review is 
a preliminary analysis, and findings should not determine whether the

[[Page 15157]]

control status of a substance should be changed.
    Cannabis, also known as marijuana, refers to the dried leaves, 
flowers, stems, and seeds from the Cannabis sativa or Cannabis indica 
plant. It is a complex plant substance containing multiple cannabinoids 
and other compounds, including the psychoactive chemical THC and other 
structurally similar compounds. Cannabinoids are defined as having 
activity at cannabinoid 1 and 2 (CB1 and CB2 respectively) receptors. 
Agonists of CB1 receptors are widely abused and are known to modulate 
motor coordination, memory processing, pain, and inflammation, and have 
anxiolytic effects. Marijuana is the most commonly used illicit drug in 
the United States.
    The principal cannabinoids in the cannabis plant include THC, CBD, 
and cannabinol. FDA has not approved any product containing or derived 
from botanical marijuana for any indication. These substances are 
controlled in Schedule I under the CSA. Synthetic THC (dronabinol) is 
the active ingredient in two approved drug products in the United 
States, MARINOL capsules (and generics) and SYNDROS oral solution. 
MARINOL is controlled in Schedule III, while SYNDROS is controlled in 
Schedule II under the CSA. Both MARINOL and SYNDROS are approved to 
treat anorexia associated with weight loss in patients with acquired 
immunodeficiency syndrome (AIDS), and nausea and vomiting associated 
with cancer chemotherapy in patients who have failed to respond 
adequately to conventional treatment.
    CBD is another cannabinoid identified in cannabis. CBD has been 
tested in experimental animal and laboratory models of several 
neurological disorders, including those of seizure and epilepsy. In the 
United States, CBD-containing products are in human clinical testing in 
several therapeutic areas, but no such products have marketing approval 
by FDA for any medical purposes in the United States. CBD is controlled 
as a Schedule I substance under the CSA. CBD is not specifically listed 
in the schedules of the 1961, 1971, or 1988 International Drug Control 
conventions.
    At the 39th (2017) meeting of the ECDD, the committee pre-reviewed 
CBD and recommended that extracts or preparations containing almost 
exclusively CBD be subject to critical review at the 40th ECDD meeting.

IV. Opportunity To Submit Domestic Information

    As required by paragraph (d)(2)(A) of the CSA, FDA, on behalf of 
HHS, invites interested persons to submit comments regarding the five 
drug substances. Any comments received will be considered by HHS when 
it prepares a scientific and medical evaluation of these drug 
substances, responsive to the WHO Questionnaire request for these drug 
substances. HHS will forward such evaluation of these drug substances 
to WHO, for WHO's consideration in deciding whether to recommend 
international control/decontrol of any of these drug substances. Such 
control could limit, among other things, the manufacture and 
distribution (import/export) of these drug substances and could impose 
certain recordkeeping requirements on them.
    Although FDA is, through this notice, requesting comments from 
interested persons, which will be considered by HHS when it prepares an 
evaluation of these drug substances, HHS will not now make any 
recommendations to WHO regarding whether any of these drugs should be 
subjected to international controls. Instead, HHS will defer such 
consideration until WHO has made official recommendations to the 
Commission on Narcotic Drugs, which are expected to be made in mid-
2018. Any HHS position regarding international control of these drug 
substances will be preceded by another Federal Register notice 
soliciting public comments, as required by paragraph (d)(2)(B) of the 
CSA.

    Dated: April 4, 2018.
Leslie Kux,
Associate Commissioner for Policy.
[FR Doc. 2018-07225 Filed 4-6-18; 8:45 am]
 BILLING CODE 4164-01-P