Withdrawal of Notice of Intent to Temporarily Place Mitragynine and 7-Hydroxymitragynine Into Schedule I, 70652-70654 [2016-24659]
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70652
Federal Register / Vol. 81, No. 198 / Thursday, October 13, 2016 / Proposed Rules
as a result of this proposed rule would
be less than two percent, or an
estimated $37,151.00, of the estimated
total $1,857,560.00 cost to all steel
importers to process the on-line
automatic licenses. These calculations
were based on an hourly pay rate of
$20.00 multiplied by the estimated
92,878 total annual burden hours. Based
on the current patterns of license
applications, the vast majority of the
licenses are applied for by large
companies. The approximate cost of a
single license is less than 10 minutes of
the applicant’s time and this is reduced
if applicants use templates or the
electronic data interface for multiple
licenses. This amounts to an average
cost per license of $3.33.
This proposed rule contains
collection-of-information requirements
subject to review and approval by the
Office of Management and Budget
(OMB) under the Paperwork Reduction
Act (PRA).
These requirements have been
approved by OMB (OMB No.: 0625–
0245; Expiration Date: 1/31/2018).
Public reporting for this collection of
information is estimated to be less than
10 minutes per response, including the
time for reviewing instructions, and
completing and reviewing the collection
of information.
Paperwork Reduction Act Data
OMB Number: 0625–0245.
ITA Number: ITA–4141P.
Type of Review: Regular Submission.
Affected Public: Business or other forprofit.
Estimated Number of Registered
Users: 3,500.
Estimated Time per Response: Less
than 10 minutes.
Estimated Total Annual Burden
Hours: 92,878 hours.
Estimated Total Annual Costs: $0.00.
Notwithstanding any other provision
of law, no person is required to respond
to nor shall a person be subject to a
penalty for failure to comply with a
collection of information subject to the
requirements of the Paperwork
Reduction Act unless that collection of
information displays a current valid
OMB Control Number.
Lhorne on DSK30JT082PROD with PROPOSALS
This rule has been determined to be
not significant for purposes of Executive
Order 12866.
Executive Order 13132
This rule does not contain policies
with federalism implications as that
term is defined in EO 13132.
13:36 Oct 12, 2016
Administrative practice and
procedure, Business and industry,
Imports, Reporting and recordkeeping
requirements, Steel.
Dated: October 4, 2016.
Ken Hyatt,
Acting Under Secretary for International
Trade.
For the reasons discussed above, we
propose amending 19 CFR part 360 as
follows:
PART 360—STEEL IMPORT
MONITORING AND ANALYSIS SYSTEM
1. The authority citation for part 360
continues to read as follows:
■
Authority: 13 U.S.C. 301(a) and 302.
2. Section 360.105 is revised to read
as follows.
■
§ 360.105 Duration of the steel import
licensing requirement.
The licensing program will be in
effect through March 21, 2022, but may
be extended upon review and
notification in the Federal Register
prior to this expiration date. Licenses
will be required for all subject imports
entered during this period, even if the
entry summary documents are not filed
until after the expiration of this
program. The licenses will be valid for
10 business days after the expiration of
this program to allow for the final filing
of required Customs documentation.
[FR Doc. 2016–24649 Filed 10–12–16; 8:45 am]
BILLING CODE 3510–DS–P
DEPARTMENT OF JUSTICE
Drug Enforcement Administration
21 CFR Part 1308
[Docket No. DEA–442W]
Withdrawal of Notice of Intent to
Temporarily Place Mitragynine and 7Hydroxymitragynine Into Schedule I
Drug Enforcement
Administration, Department of Justice.
ACTION: Withdrawal of Notice of Intent;
Solicitation of Comments.
AGENCY:
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
SUMMARY:
Executive Order 12866
VerDate Sep<11>2014
List of Subjects in 19 CFR Part 360
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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 7hydroxymitragynine 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 https://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
E:\FR\FM\13OCP1.SGM
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Federal Register / Vol. 81, No. 198 / Thursday, October 13, 2016 / Proposed Rules
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:
Lhorne on DSK30JT082PROD with PROPOSALS
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 https://
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
VerDate Sep<11>2014
13:36 Oct 12, 2016
Jkt 241001
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 https://
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 7hydroxymitragynine, which are the
main psychoactive constituents of the
plant commonly known as kratom. 81
FR 59929.
In response to the notice of intent,
DEA received numerous comments from
the public on mitragynine and 7hydroxymitragynine, 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
1 The Attorney General has delegated her
functions under the CSA to the DEA Administrator.
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).
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70653
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
Consideration of Public Comments and
FDA’s Analysis
With respect to mitragynine and 7hydroxymitragynine, 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 7hydroxymitragynine, 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.
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
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.
3 Under some state and local laws, kratom and/
or its constituents mitragynine and 7hydroxymitragynine 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.
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).
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Federal Register / Vol. 81, No. 198 / Thursday, October 13, 2016 / Proposed Rules
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
electronically via the Federal
eRulemaking Portal at https://
www.regulations.gov (indicate IRS and
REG–108934–16). The public hearing
will be held in the Main IR Auditorium
beginning at 10:00 a.m. in the Internal
Revenue Service Building, 1111
Constitution Avenue NW., Washington,
DC 20224.
FOR FURTHER INFORMATION CONTACT:
Concerning the proposed amendments
to the regulations, Maria Del Pilar
Austin at (202) 317–5437; concerning
submissions of comments, the hearing,
or to be placed on the building access
list to attend the hearing, Regina
Johnson, at (202) 317–6901; concerning
cost methodology, Eva Williams, at
(202) 803–9728 (not toll-free numbers).
SUPPLEMENTARY INFORMATION:
DEPARTMENT OF THE TREASURY
Background
Internal Revenue Service
This document contains proposed
regulations that would amend § 300.3 of
the User Fee Regulations (26 CFR part
300), which provides for a user fee
applicable to offers in compromise
under section 7122 of the Internal
Revenue Code (Code).
Section 7122(a) provides the Secretary
the authority to compromise any civil or
criminal case arising under the internal
revenue laws, prior to the referral of that
case to the Department of Justice.
Section 7122(d)(1) requires the IRS to
prescribe guidelines for officers and
employees of the IRS to determine
whether an offer in compromise is
adequate and should be accepted to
resolve a dispute. Those guidelines can
generally be found in § 301.7122–1.
Under those guidelines, an offer in
compromise may be accepted if there is
doubt as to liability, if there is doubt as
to collectability, or if acceptance will
promote effective tax administration.
See § 301.7122–1(b).
When the IRS receives an offer in
compromise, it initially determines
whether the taxpayer submitting the
offer is eligible for the offer in
compromise program and, if the
taxpayer is eligible, whether the offer
submitted is otherwise processable.
Currently, a taxpayer may be ineligible
for the offer in compromise program for
a number of reasons, including if the
taxpayer is in bankruptcy or has not
filed all required tax returns. The IRS
will return an offer as nonprocessable if
the taxpayer is ineligible or if the offer
has not been properly submitted.
If the IRS determines the offer in
compromise is processable, then except
where the offer is made under section
7122(d)(3)(B) relating only to issues of
liability and the case is processed
without a financial investigation, the
26 CFR Part 300
[REG–108934–16]
RIN 1545–BN38
User Fees for Offers in Compromise
Internal Revenue Service (IRS),
Treasury.
ACTION: Notice of proposed rulemaking
and notice of public hearing.
AGENCY:
This document contains
proposed amendments to the
regulations that provide user fees for
offers in compromise. The proposed
amendments affect taxpayers who wish
to pay their liabilities through offers in
compromise. The proposed effective
date for these proposed amendments to
the regulations is for offers in
compromise submitted on or after
February 27, 2017. This document also
provides a notice of public hearing on
these proposed amendments to the
regulations.
SUMMARY:
Written or electronic comments
must be received by November 28, 2016.
Outlines of topics to be discussed at the
public hearing scheduled for December
16, 2016 at 10:00 a.m. must be received
by November 28, 2016.
ADDRESSES: Send submissions to:
Internal Revenue Service,
CC:PA:LPD:PR (REG–108934–16), Room
5203, Post Office Box 7604, Ben
Franklin Station, Washington, DC
20044. Submissions may be handdelivered Monday through Friday
between the hours of 8 a.m. and 4 p.m.
to CC:PA:LPD:PR (REG–108934–16),
Courier’s Desk, Internal Revenue
Service, 1111 Constitution Avenue NW.,
Washington, DC 20224 or sent
Lhorne on DSK30JT082PROD with PROPOSALS
DATES:
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13:36 Oct 12, 2016
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PO 00000
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IRS investigates and verifies the
taxpayer’s financial information
submitted with the offer to determine
whether such a compromise is
appropriate before accepting the terms
of the offer in compromise. If the IRS
initially rejects a processable offer in
compromise based on an investigation
of the taxpayer’s financial position,
section 7122(e)(1) provides that the IRS
must conduct an independent
administrative review of that decision
before communicating the rejection to
the taxpayer. If the independent
administrative review upholds the IRS’s
initial decision to reject a processable
offer in compromise, section 7122(e)(2)
provides that the taxpayer is notified of
the rejection and has the right to appeal
the rejection to the IRS’s Appeals Office.
When the IRS accepts an offer in
compromise, the IRS processes the
payments and monitors the taxpayer’s
compliance with the terms of the offer.
Under § 300.3, the IRS currently
charges $186 for processing an offer in
compromise, which includes reviewing
and monitoring the offer. Under
§ 300.3(b)(2)(i) and (ii), if a fee is
charged and the offer is accepted to
promote effective tax administration or
accepted based on doubt as to
collectability where the IRS has
determined that collection of an amount
greater than the amount offered would
create economic hardship, then the user
fee is applied against the amount to be
paid under the offer unless the taxpayer
requests that it be refunded. Section
300.3(b)(1)(i) and (ii) provide that no fee
is charged if an offer is based solely on
doubt as to liability, or made by a lowincome taxpayer.
Explanation of Provisions
A. Overview
To bring the user fee rate for offers in
compromise closer to the full cost to the
IRS of providing this taxpayer specific
service, the proposed regulations under
§ 300.3 would increase the user fee for
an offer in compromise to $300. The
proposed regulations do not modify
other portions of the User Fee
Regulations regarding offers in
compromise, such as § 300.3(b)(1)(i) and
(ii) which waive the user fee for offers
in compromise submitted by lowincome taxpayers and offers in
compromise based solely on doubt as to
liability. The increased user fee for
offers in compromise is proposed to be
effective for offers submitted on or after
February 27, 2017.
B. User Fee Authority
The Independent Offices
Appropriations Act (IOAA) (31 U.S.C.
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]]>Agencies
[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 https://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 https://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 https://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.
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\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).
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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
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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
