[Federal Register Volume 81, Number 198 (Thursday, October 13, 2016)]
[Proposed Rules]
[Pages 70652-70654]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2016-24659]
=======================================================================
-----------------------------------------------------------------------
DEPARTMENT OF JUSTICE
Drug Enforcement Administration
21 CFR Part 1308
[Docket No. DEA-442W]
Withdrawal of Notice of Intent to Temporarily Place Mitragynine
and 7-Hydroxymitragynine Into Schedule I
AGENCY: Drug Enforcement Administration, Department of Justice.
ACTION: Withdrawal of Notice of Intent; Solicitation of Comments.
-----------------------------------------------------------------------
SUMMARY: On August 31, 2016, the Drug Enforcement Administration (DEA)
published in the Federal Register a notice of intent to temporarily
place mitragynine and 7-hydroxymitragynine, which are the main
psychoactive constituents of the plant Mitragyna speciosa, also
referred to as kratom, into schedule I pursuant to the temporary
scheduling provisions of the Controlled Substances Act. Since
publishing that notice, DEA has received numerous comments from members
of the public challenging the scheduling action and requesting that the
agency consider those comments and accompanying information before
taking further action. In addition, DEA will receive from the Food and
Drug Administration (FDA) a scientific and medical evaluation and
scheduling recommendation for these substances, which DEA previously
requested.
DEA is therefore taking the following actions: DEA is withdrawing
the August 31, 2016 notice of intent; and soliciting comments from the
public regarding the scheduling of mitragynine and 7-hydroxymitragynine
under the Controlled Substances Act.
DATES: The notice of intent that was published on August 31, 2016 (81
FR 59929) is withdrawn as of October 13, 2016. The comment period will
be open until December 1, 2016. All comments for the public record must
be submitted electronically or in writing in accordance with the
procedures outlined below. Electronic comments must be submitted, and
written comments must be postmarked, on or before December 1, 2016.
Commenters should be aware that the electronic Federal Docket
Management System will not accept comments after 11:59 p.m. Eastern
Time on the last day of the comment period. Please note that if you
previously submitted a comment via email or regular mail following the
August 31, 2016 notice, that comment is being considered by DEA--it is
not necessary to resubmit the same comment unless you wish to provide
additional information, or you wish to have your comment posted for
public view in accordance with the instructions provided below.
ADDRESSES: To ensure proper handling of comments, please reference
``Docket No. DEA-442W'' on all correspondence, including any
attachments.
Electronic comments: The Drug Enforcement Administration
encourages that all comments be submitted electronically through the
Federal eRulemaking Portal, which provides the ability to type short
comments directly into the comment field on the Web page or attach a
file for lengthier comments. Please go to http://www.regulations.gov
and follow the online instructions at that site for submitting
comments. Upon completion of your submission, you will receive a
Comment Tracking Number for your comment. Please be aware that
submitted comments are not instantaneously available for public view on
Regulations.gov. If you have
[[Page 70653]]
received a Comment Tracking Number, your comment has been successfully
submitted and there is no need to resubmit the same comment.
Paper comments: Paper comments that duplicate the
electronic submission are not necessary and are discouraged. Should you
wish to mail a paper comment in lieu of an electronic comment, it
should be sent via regular or express mail to: Drug Enforcement
Administration, Attn: DEA Federal Register Representative/ODW, 8701
Morrissette Drive, Springfield, Virginia 22152.
FOR FURTHER INFORMATION CONTACT: Michael J. Lewis, Diversion Control
Division, Drug Enforcement Administration; Mailing Address: 8701
Morrissette Drive, Springfield, Virginia 22152; Telephone: (202) 598-
6812.
SUPPLEMENTARY INFORMATION:
Posting of Public Comments
Please note that all comments received in response to this notice
are considered part of the public record. If you previously submitted a
comment via email or regular mail following the August 31, 2016 notice,
that comment is being considered by DEA--it is not necessary to
resubmit the same comment unless you wish to provide additional
information, or you wish to have your comment posted for public view in
accordance with the instructions provided below.
All comments received in response to this notice of opportunity to
comment will, unless reasonable cause is given, be made available by
DEA for public inspection online at http://www.regulations.gov. Such
information includes personal identifying information (such as your
name, address, etc.) voluntarily submitted by the commenter. The
Freedom of Information Act (FOIA) applies to all comments received. If
you want to submit personal identifying information (such as your name,
address, etc.) as part of your comment, but do not want it to be made
publicly available, you must include the phrase ``PERSONAL IDENTIFYING
INFORMATION'' in the first paragraph of your comment. You must also
place all of the personal identifying information you do not want made
publicly available in the first paragraph of your comment and identify
what information you want redacted.
If you want to submit confidential business information as part of
your comment, but do not want it to be made publicly available, you
must include the phrase ``CONFIDENTIAL BUSINESS INFORMATION'' in the
first paragraph of your comment. You must also prominently identify the
confidential business information to be redacted within the comment.
Comments containing personal identifying information and
confidential business information identified as directed above will
generally be made publicly available in redacted form. If a comment has
so much personal identifying information or confidential business
information that it cannot be effectively redacted, all or part of that
comment may not be made publicly available. Comments posted to http://www.regulations.gov may include any personal identifying information
(such as name, address, and phone number) or confidential business
information included in the text of your electronic submission that is
not identified as directed above as personal or confidential.
Background
Withdrawal of Notice of Intent
The Controlled Substances Act (CSA) contains a temporary scheduling
provision, 21 U.S.C. 811(h), pursuant to which the DEA Administrator
\1\ may temporarily place a substance in schedule I where he finds that
doing so is necessary to avoid an imminent hazard to the public safety.
This provision of the CSA requires DEA to publish a notice in the
Federal Register of its intent to issue a temporary scheduling order at
least 30 days before issuing any such order. DEA published such a
notice of intent on August 31, 2016, with respect to mitragynine and 7-
hydroxymitragynine, which are the main psychoactive constituents of the
plant commonly known as kratom. 81 FR 59929.
---------------------------------------------------------------------------
\1\ The Attorney General has delegated her functions under the
CSA to the DEA Administrator.
---------------------------------------------------------------------------
In response to the notice of intent, DEA received numerous comments
from the public on mitragynine and 7-hydroxymitragynine, including
comments offering their opinions regarding the pharmacological effects
of these substances. To allow consideration of these comments, as well
as others received on or before December 1, 2016, DEA has decided to
withdraw the August 31, 2016 notice of intent published at 81 FR 59929.
DEA has also requested that the FDA expedite its scientific and medical
evaluation and scheduling recommendation for these substances, which
DEA previously requested in accordance with 21 U.S.C. 811(b).\2\
---------------------------------------------------------------------------
\2\ Section 811(b) provides that the scientific and medical
evaluation and scheduling recommendation shall be conducted by the
Secretary of Health and Human Services (HHS). This function has been
delegated to the Assistant Secretary for Health. 58 FR 35460 (1993).
Within HHS, the FDA has primary responsibility for conducting the
evaluation and making the recommendation.
---------------------------------------------------------------------------
Accordingly, the August 31, 2016, notice of intent to temporarily
place mitragynine and 7-hydroxymitragynine in schedule I is withdrawn.
Mitragynine and 7-hydroxymitragynine therefore remain--as has been the
case--noncontrolled substances under federal law.\3\
---------------------------------------------------------------------------
\3\ Under some state and local laws, kratom and/or its
constituents mitragynine and 7-hydroxymitragynine are currently
listed as controlled substances or otherwise subject to control.
Nothing in this publication alters the validity of such laws, or any
pending state efforts to implement those laws or enact new laws
controlling these substances.
---------------------------------------------------------------------------
Consideration of Public Comments and FDA's Analysis
With respect to mitragynine and 7-hydroxymitragynine, DEA will
consider all public comments received under the above procedures, as
well as FDA's scientific and medical evaluation and scheduling
recommendation for these substances. Once DEA has received and
considered all of this information, DEA will decide whether to proceed
with permanent scheduling of mitragynine and 7-hydroxymitragynine, or
both permanent and temporary scheduling of these substances.
Permanent Scheduling Process: As the CSA provides, if DEA
determines that the medical and scientific facts contained in the FDA
scheduling evaluation, along with all other relevant data and
information, constitute substantial evidence of potential for abuse to
support permanent scheduling of mitragynine and 7-hydroxymitragynine,
DEA will publish in the Federal Register a notice of proposed
rulemaking, which will give interested members of the public an
additional opportunity to submit comments and request a hearing.\4\ As
provided in 21 U.S.C. 811(a), permanent scheduling rules shall be made
on the record after opportunity for a hearing pursuant to the
rulemaking procedures prescribed by 5 U.S.C. 553, 556, and 557.
---------------------------------------------------------------------------
\4\ In permanent scheduling actions, when DEA reviews the FDA
evaluation and scheduling recommendation, the FDA determinations as
to scientific and medical matters are binding on DEA. 21 U.S.C.
811(b).
---------------------------------------------------------------------------
Temporary Scheduling Process: The pendency of permanent scheduling
proceedings for a substance does not preclude a simultaneous or
subsequent order to temporarily control that substance. If DEA finds in
light of FDA's scientific and medical evaluation and after
consideration of all public
[[Page 70654]]
comments and other relevant information that, based on the criteria of
section 811(h), temporary placement of mitragynine and 7-
hydroxymitragynine in schedule I is necessary to avoid an imminent
hazard to the public safety, DEA will follow the statutory procedures
for issuing such a temporary scheduling order. As indicated above,
before issuing such a temporary scheduling order, DEA would be required
---------------------------------------------------------------------------
to publish in the Federal Register a new notice of intent.
Dated: October 6, 2016.
Chuck Rosenberg,
Acting Administrator.
[FR Doc. 2016-24659 Filed 10-12-16; 8:45 am]
BILLING CODE 4410-09-P