81 FR 70652 - Withdrawal of Notice of Intent to Temporarily Place Mitragynine and 7-Hydroxymitragynine Into Schedule I
DEPARTMENT OF JUSTICE
Drug Enforcement Administration Federal Register Volume 81, Issue 198 (October 13, 2016)
Drug Enforcement Administration
Federal Register Volume 81, Issue 198 (October 13, 2016)
| Page Range | 70652-70654 | |
| FR Document | 2016-24659 |
[Federal Register Volume 81, Number 198 (Thursday, October 13, 2016)] [Proposed Rules] [Pages 70652-70654] From the Federal Register Online [www.thefederalregister.org] [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 DATES: The notice of intent that was published on August 31, 2016 (81 FR 59929) is withdrawn as of October 13, 2016.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
![70652 Federal Register / Vol. 81, No. 198 / Thursday, October 13, 2016 / Proposed Rules
as a result of this proposed rule would List of Subjects in 19 CFR Part 360 Substances Act. Since publishing that
be less than two percent, or an Administrative practice and notice, DEA has received numerous
estimated $37,151.00, of the estimated procedure, Business and industry, comments from members of the public
total $1,857,560.00 cost to all steel Imports, Reporting and recordkeeping challenging the scheduling action and
importers to process the on-line requirements, Steel. requesting that the agency consider
automatic licenses. These calculations those comments and accompanying
were based on an hourly pay rate of Dated: October 4, 2016. information before taking further action.
$20.00 multiplied by the estimated Ken Hyatt, In addition, DEA will receive from the
92,878 total annual burden hours. Based Acting Under Secretary for International Food and Drug Administration (FDA) a
on the current patterns of license Trade. scientific and medical evaluation and
applications, the vast majority of the For the reasons discussed above, we scheduling recommendation for these
licenses are applied for by large propose amending 19 CFR part 360 as substances, which DEA previously
companies. The approximate cost of a follows: requested.
single license is less than 10 minutes of DEA is therefore taking the following
the applicant’s time and this is reduced PART 360—STEEL IMPORT actions: DEA is withdrawing the August
if applicants use templates or the MONITORING AND ANALYSIS SYSTEM 31, 2016 notice of intent; and soliciting
electronic data interface for multiple comments from the public regarding the
licenses. This amounts to an average ■ 1. The authority citation for part 360 scheduling of mitragynine and 7-
cost per license of $3.33. continues to read as follows: hydroxymitragynine under the
This proposed rule contains Authority: 13 U.S.C. 301(a) and 302. Controlled Substances Act.
collection-of-information requirements DATES: The notice of intent that was
■ 2. Section 360.105 is revised to read
subject to review and approval by the as follows. published on August 31, 2016 (81 FR
Office of Management and Budget 59929) is withdrawn as of October 13,
(OMB) under the Paperwork Reduction § 360.105 Duration of the steel import 2016. The comment period will be open
Act (PRA). licensing requirement. until December 1, 2016. All comments
These requirements have been The licensing program will be in for the public record must be submitted
approved by OMB (OMB No.: 0625– effect through March 21, 2022, but may electronically or in writing in
0245; Expiration Date: 1/31/2018). be extended upon review and accordance with the procedures
Public reporting for this collection of notification in the Federal Register outlined below. Electronic comments
information is estimated to be less than prior to this expiration date. Licenses must be submitted, and written
10 minutes per response, including the will be required for all subject imports comments must be postmarked, on or
time for reviewing instructions, and entered during this period, even if the before December 1, 2016. Commenters
completing and reviewing the collection entry summary documents are not filed should be aware that the electronic
of information. until after the expiration of this Federal Docket Management System
program. The licenses will be valid for will not accept comments after 11:59
Paperwork Reduction Act Data p.m. Eastern Time on the last day of the
10 business days after the expiration of
OMB Number: 0625–0245. this program to allow for the final filing comment period. Please note that if you
ITA Number: ITA–4141P. of required Customs documentation. previously submitted a comment via
Type of Review: Regular Submission. [FR Doc. 2016–24649 Filed 10–12–16; 8:45 am] email or regular mail following the
August 31, 2016 notice, that comment is
Affected Public: Business or other for- BILLING CODE 3510–DS–P
being considered by DEA—it is not
profit.
necessary to resubmit the same
Estimated Number of Registered comment unless you wish to provide
Users: 3,500. DEPARTMENT OF JUSTICE
additional information, or you wish to
Estimated Time per Response: Less have your comment posted for public
than 10 minutes. Drug Enforcement Administration
view in accordance with the
Estimated Total Annual Burden instructions provided below.
21 CFR Part 1308
Hours: 92,878 hours. ADDRESSES: To ensure proper handling
Estimated Total Annual Costs: $0.00. [Docket No. DEA–442W] of comments, please reference ‘‘Docket
Notwithstanding any other provision No. DEA–442W’’ on all correspondence,
Withdrawal of Notice of Intent to
of law, no person is required to respond including any attachments.
Temporarily Place Mitragynine and 7-
to nor shall a person be subject to a • Electronic comments: The Drug
Hydroxymitragynine Into Schedule I
penalty for failure to comply with a Enforcement Administration encourages
collection of information subject to the AGENCY: Drug Enforcement that all comments be submitted
requirements of the Paperwork Administration, Department of Justice. electronically through the Federal
Reduction Act unless that collection of ACTION: Withdrawal of Notice of Intent; eRulemaking Portal, which provides the
information displays a current valid Solicitation of Comments. ability to type short comments directly
OMB Control Number. into the comment field on the Web page
SUMMARY: On August 31, 2016, the Drug or attach a file for lengthier comments.
Executive Order 12866
Enforcement Administration (DEA) Please go to http://www.regulations.gov
This rule has been determined to be published in the Federal Register a and follow the online instructions at
Lhorne on DSK30JT082PROD with PROPOSALS
not significant for purposes of Executive notice of intent to temporarily place that site for submitting comments. Upon
Order 12866. mitragynine and 7-hydroxymitragynine, completion of your submission, you will
which are the main psychoactive receive a Comment Tracking Number for
Executive Order 13132
constituents of the plant Mitragyna your comment. Please be aware that
This rule does not contain policies speciosa, also referred to as kratom, into submitted comments are not
with federalism implications as that schedule I pursuant to the temporary instantaneously available for public
term is defined in EO 13132. scheduling provisions of the Controlled view on Regulations.gov. If you have
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![70654 Federal Register / Vol. 81, No. 198 / Thursday, October 13, 2016 / Proposed Rules
comments and other relevant electronically via the Federal IRS investigates and verifies the
information that, based on the criteria of eRulemaking Portal at http:// taxpayer’s financial information
section 811(h), temporary placement of www.regulations.gov (indicate IRS and submitted with the offer to determine
mitragynine and 7-hydroxymitragynine REG–108934–16). The public hearing whether such a compromise is
in schedule I is necessary to avoid an will be held in the Main IR Auditorium appropriate before accepting the terms
imminent hazard to the public safety, beginning at 10:00 a.m. in the Internal of the offer in compromise. If the IRS
DEA will follow the statutory Revenue Service Building, 1111 initially rejects a processable offer in
procedures for issuing such a temporary Constitution Avenue NW., Washington, compromise based on an investigation
scheduling order. As indicated above, DC 20224. of the taxpayer’s financial position,
before issuing such a temporary FOR FURTHER INFORMATION CONTACT: section 7122(e)(1) provides that the IRS
scheduling order, DEA would be Concerning the proposed amendments must conduct an independent
required to publish in the Federal to the regulations, Maria Del Pilar administrative review of that decision
Register a new notice of intent. Austin at (202) 317–5437; concerning before communicating the rejection to
Dated: October 6, 2016. submissions of comments, the hearing, the taxpayer. If the independent
Chuck Rosenberg, or to be placed on the building access administrative review upholds the IRS’s
list to attend the hearing, Regina initial decision to reject a processable
Acting Administrator.
Johnson, at (202) 317–6901; concerning offer in compromise, section 7122(e)(2)
[FR Doc. 2016–24659 Filed 10–12–16; 8:45 am]
cost methodology, Eva Williams, at provides that the taxpayer is notified of
BILLING CODE 4410–09–P the rejection and has the right to appeal
(202) 803–9728 (not toll-free numbers).
SUPPLEMENTARY INFORMATION: the rejection to the IRS’s Appeals Office.
When the IRS accepts an offer in
DEPARTMENT OF THE TREASURY Background compromise, the IRS processes the
This document contains proposed payments and monitors the taxpayer’s
Internal Revenue Service compliance with the terms of the offer.
regulations that would amend § 300.3 of
the User Fee Regulations (26 CFR part Under § 300.3, the IRS currently
26 CFR Part 300 charges $186 for processing an offer in
300), which provides for a user fee
[REG–108934–16] applicable to offers in compromise compromise, which includes reviewing
under section 7122 of the Internal and monitoring the offer. Under
RIN 1545–BN38
Revenue Code (Code). § 300.3(b)(2)(i) and (ii), if a fee is
User Fees for Offers in Compromise Section 7122(a) provides the Secretary charged and the offer is accepted to
the authority to compromise any civil or promote effective tax administration or
AGENCY: Internal Revenue Service (IRS), criminal case arising under the internal accepted based on doubt as to
Treasury. revenue laws, prior to the referral of that collectability where the IRS has
ACTION: Notice of proposed rulemaking case to the Department of Justice. determined that collection of an amount
and notice of public hearing. Section 7122(d)(1) requires the IRS to greater than the amount offered would
prescribe guidelines for officers and create economic hardship, then the user
SUMMARY: This document contains fee is applied against the amount to be
employees of the IRS to determine
proposed amendments to the paid under the offer unless the taxpayer
whether an offer in compromise is
regulations that provide user fees for requests that it be refunded. Section
adequate and should be accepted to
offers in compromise. The proposed 300.3(b)(1)(i) and (ii) provide that no fee
resolve a dispute. Those guidelines can
amendments affect taxpayers who wish is charged if an offer is based solely on
generally be found in § 301.7122–1.
to pay their liabilities through offers in doubt as to liability, or made by a low-
Under those guidelines, an offer in
compromise. The proposed effective income taxpayer.
compromise may be accepted if there is
date for these proposed amendments to
doubt as to liability, if there is doubt as Explanation of Provisions
the regulations is for offers in
to collectability, or if acceptance will
compromise submitted on or after A. Overview
promote effective tax administration.
February 27, 2017. This document also
See § 301.7122–1(b). To bring the user fee rate for offers in
provides a notice of public hearing on
When the IRS receives an offer in compromise closer to the full cost to the
these proposed amendments to the
compromise, it initially determines IRS of providing this taxpayer specific
regulations.
whether the taxpayer submitting the service, the proposed regulations under
DATES: Written or electronic comments offer is eligible for the offer in § 300.3 would increase the user fee for
must be received by November 28, 2016. compromise program and, if the an offer in compromise to $300. The
Outlines of topics to be discussed at the taxpayer is eligible, whether the offer proposed regulations do not modify
public hearing scheduled for December submitted is otherwise processable. other portions of the User Fee
16, 2016 at 10:00 a.m. must be received Currently, a taxpayer may be ineligible Regulations regarding offers in
by November 28, 2016. for the offer in compromise program for compromise, such as § 300.3(b)(1)(i) and
ADDRESSES: Send submissions to: a number of reasons, including if the (ii) which waive the user fee for offers
Internal Revenue Service, taxpayer is in bankruptcy or has not in compromise submitted by low-
CC:PA:LPD:PR (REG–108934–16), Room filed all required tax returns. The IRS income taxpayers and offers in
5203, Post Office Box 7604, Ben will return an offer as nonprocessable if compromise based solely on doubt as to
Franklin Station, Washington, DC the taxpayer is ineligible or if the offer
Lhorne on DSK30JT082PROD with PROPOSALS
liability. The increased user fee for
20044. Submissions may be hand- has not been properly submitted. offers in compromise is proposed to be
delivered Monday through Friday If the IRS determines the offer in effective for offers submitted on or after
between the hours of 8 a.m. and 4 p.m. compromise is processable, then except February 27, 2017.
to CC:PA:LPD:PR (REG–108934–16), where the offer is made under section
Courier’s Desk, Internal Revenue 7122(d)(3)(B) relating only to issues of B. User Fee Authority
Service, 1111 Constitution Avenue NW., liability and the case is processed The Independent Offices
Washington, DC 20224 or sent without a financial investigation, the Appropriations Act (IOAA) (31 U.S.C.
VerDate Sep<11>2014 13:36 Oct 12, 2016 Jkt 241001 PO 00000 Frm 00008 Fmt 4702 Sfmt 4702 E:\FR\FM\13OCP1.SGM 13OCP1](https://thefederalregister.org/doc/81_FR_70850/page/3.svg)
Document Created: 2016-10-13 00:53:42
Document Modified: 2016-10-13 00:53:42
| Category | Regulatory Information | |
| Collection | Federal Register | |
| sudoc Class | AE 2.7: GS 4.107: AE 2.106: | |
| Publisher | Office of the Federal Register, National Archives and Records Administration | |
| Section | Proposed Rules | |
| Action | Withdrawal of Notice of Intent; Solicitation of Comments. | |
| 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. | |
| Contact | Michael J. Lewis, Diversion Control | |
| FR Citation | 81 FR 70652 |
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