[Federal Register Volume 86, Number 77 (Friday, April 23, 2021)]
[Notices]
[Pages 21814-21911]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2021-06689]



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Vol. 86

Friday,

No. 77

April 23, 2021

Part II





Department of Justice





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Drug Enforcement Administration





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Exempt Chemical Preparations Under the Controlled Substances Act; 
Notice

  Federal Register / Vol. 86 , No. 77 / Friday, April 23, 2021 / 
Notices  

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DEPARTMENT OF JUSTICE

Drug Enforcement Administration

[Docket No. DEA-372]


Exempt Chemical Preparations Under the Controlled Substances Act

AGENCY: Drug Enforcement Administration, Department of Justice.

ACTION: Order with opportunity for comment.

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SUMMARY: The applications for exempt chemical preparations received by 
the Drug Enforcement Administration (DEA) between July 1, 2018, and 
December 31, 2020, as listed below, were accepted for filing and have 
been approved or denied as indicated.

DATES: Interested persons may file written comments on this order in 
accordance with 21 CFR 1308.23(e). Electronic comments must be 
submitted, and written comments must be postmarked, on or before June 
22, 2021. 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.

ADDRESSES: To ensure proper handling of comments, please reference 
``Docket No. DEA-372'' on all correspondence, including any 
attachments.
    Electronic comments: DEA encourages that all comments be submitted 
through the Federal eRulemaking Portal, which provides the ability to 
type short comments directly into the comment field on the web page or 
to 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 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 comment in lieu of an electronic comment, it should be sent via 
regular or express mail to: Drug Enforcement Administration, Attention: 
DEA Federal Register Representative/DRW, 8701 Morrissette Drive, 
Springfield, Virginia 22152.

FOR FURTHER INFORMATION CONTACT: Terrence L. Boos, Ph.D., Diversion 
Control Division, Drug Enforcement Administration; Telephone: (571) 
362-8201.

SUPPLEMENTARY INFORMATION:

Posting of Public Comments

    Please note that all comments received are considered part of the 
public record and made available for public inspection online at http://www.regulations.gov and in the DEA's public docket. Such information 
includes personal identifying information (such as your name, address, 
etc.) voluntarily submitted by the commenter. The Freedom of 
Information Act 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 posted online or made available in the public docket, you must 
include the phrase ``PERSONAL IDENTIFYING INFORMATION'' in the first 
paragraph of your comment. You must also place all the personal 
identifying information you do not want posted online or made available 
in the public docket 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 posted online or made available 
in the public docket, you must include the phrase ``CONFIDENTIAL 
BUSINESS INFORMATION'' in the first paragraph of your comment. You must 
also prominently identify 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 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) included in the text of your electronic submission that is not 
identified as directed above as confidential.
    An electronic copy of this document is available at http://www.regulations.gov for easy reference.

Legal Authority

    Section 201 of the Controlled Substances Act (CSA) (21 U.S.C. 811) 
authorizes the Attorney General, by regulation, to exempt from certain 
provisions of the CSA certain compounds, mixtures, or preparations 
containing a controlled substance, if he finds that such compounds, 
mixtures, or preparations meet the requirements detailed in 21 U.S.C. 
811(g)(3)(B).\1\ The DEA regulations at 21 CFR 1308.23 and 1308.24 
further detail the criteria by which the DEA Assistant Administrator 
may exempt a chemical preparation or mixture from certain provisions of 
the CSA. The Assistant Administrator may, pursuant to 21 CFR 
1308.23(f), modify or revoke the criteria by which exemptions are 
granted and modify the scope of exemptions at any time.
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    \1\ This authority has been delegated from the Attorney General 
to the Administrator of the DEA by 28 CFR 0.100, and subsequently 
redelegated to the Deputy Assistant Administrator pursuant to 28 CFR 
0.104 and Section 7 of the appendix to subpart R of part 0.
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Exempt Chemical Preparation Applications Submitted Between July 1, 
2018, and December 31, 2020

    The Assistant Administrator received applications between July 1, 
2018, and December 31, 2020, requesting exempt chemical preparation 
status detailed in 21 CFR 1308.23. Pursuant to the criteria stated in 
21 U.S.C. 811(g)(3)(B) and in 21 CFR 1308.23, the Assistant 
Administrator has found that each of the compounds, mixtures, and 
preparations described in Chart I below is intended for laboratory, 
industrial, educational, or special research purposes and not for 
general administration to a human being or animal and either: (1) 
Contains no narcotic controlled substance and is packaged in such a 
form or concentration that the packaged quantity does not present any 
significant potential for abuse; or (2) contains either a narcotic or 
non-narcotic controlled substance and one or more adulterating or 
denaturing agents in such a manner, combination, quantity, proportion, 
or concentration that the preparation or mixture does not present any 
potential for abuse and, if the preparation or mixture contains a 
narcotic controlled substance, is formulated in such a manner that it 
incorporates methods of denaturing or other means so that the 
preparation or mixture is not liable to be abused or have ill effects, 
if abused, and so that the narcotic substance cannot in practice be 
removed.
    Accordingly, pursuant to 21 U.S.C. 811(g)(3)(B), 21 CFR 1308.23, 
and 21 CFR 1308.24, the Assistant Administrator has determined that 
each of the chemical preparations or mixtures generally described in 
Chart I below and specifically described in the application materials 
received by DEA is exempt, to the extent described in 21 CFR 1308.24,

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from application of sections 302, 303, 305, 306, 307, 308, 309, 1002, 
1003, and 1004 (21 U.S.C. 822-823, 825-829, and 952-954) of the CSA, 
and 21 CFR 1301.74, as of the date that was provided in the approval 
letters to the individual requesters.

Scope of Approval

    The exemptions are applicable only to the precise preparation or 
mixture described in the application submitted to DEA in the form(s) 
listed in this order and only for those above mentioned sections of the 
CSA and the CFR. In accordance with 21 CFR 1308.24(h), any change in 
the quantitative or qualitative composition of the preparation or 
mixture, or change in the trade name or other designation of the 
preparation or mixture after the date of application requires a new 
application. The requirements set forth in 21 CFR 1308.24(b)-(e) apply 
to the exempted materials. In accordance with 21 CFR 1308.24(g), DEA 
may prescribe requirements other than those set forth in 21 CFR 
1308.24(b)-(e) on a case-by-case basis for materials exempted in bulk 
quantities. Accordingly, in order to limit opportunity for diversion 
from the larger bulk quantities, DEA has determined that each of the 
exempted bulk products listed in this order may only be used in-house 
by the manufacturer, and may not be distributed for any purpose, or 
transported to other facilities.
    Additional exempt chemical preparation requests received between 
July 1, 2018, and December 31, 2020, and not otherwise referenced in 
this order, may remain under consideration until DEA receives 
additional information required, pursuant to 21 CFR 1308.23(d), as 
detailed in separate correspondence to individual requesters. DEA's 
order on such requests will be communicated to the public in a future 
Federal Register publication.
    DEA also notes that these exemptions are limited to exemption from 
only those sections of the CSA and the CFR that are specifically 
identified in 21 CFR 1308.24(a). All other requirements of the CSA and 
the CFR apply, including registration as an importer as required by 21 
U.S.C. 957.
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Opportunity for Comment

    Pursuant to 21 CFR 1308.23(e), any interested person may submit 
written comments on or objections to any chemical preparation in this 
order that has been approved or denied as exempt. If any comments or 
objections raise significant issues regarding any finding of fact or 
conclusion of law upon which this order is based, the Assistant 
Administrator will immediately suspend the effectiveness of any 
applicable part of this order until he may reconsider the application 
in light of the comments and objections filed. Thereafter, the 
Assistant Administrator shall reinstate, revoke, or amend his original 
order as he determines appropriate.

Approved Exempt Chemical Preparations Are Posted on the DEA's Website

    A list of all current exemptions, including those listed in this 
order, is available on the DEA's website at http://www.DEAdiversion.usdoj.gov/schedules/exempt/exempt_chemlist.pdf. The 
dates of applications of all current exemptions are posted for easy 
reference.

William T. McDermott,
Assistant Administrator.
[FR Doc. 2021-06689 Filed 4-22-21; 8:45 am]
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