[Federal Register Volume 88, Number 203 (Monday, October 23, 2023)]
[Rules and Regulations]
[Pages 72680-72683]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2023-23315]


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DEPARTMENT OF JUSTICE

Drug Enforcement Administration

21 CFR Part 1310

[Docket No. DEA-1118]


Additions to Listing of Exempt Chemical Mixtures

AGENCY: Drug Enforcement Administration, Department of Justice.

ACTION: Direct final rule.

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SUMMARY: Under this direct final rule, the Drug Enforcement 
Administration (DEA) is updating the Table of Exempt Chemical Mixtures 
to include the listing of nine additional preparations. This action is 
in response to DEA's review of new applications for exemption. Having 
reviewed applications and relevant information, DEA has found that 
these preparations meet the applicable exemption criteria. Therefore, 
this rule amends the regulations to codify that these products are 
exempted from the application of certain provisions of the Controlled 
Substances Act.

DATES: This direct final rule is effective December 22, 2023 without 
further action, unless DEA receives adverse comment by DEA no later 
than November 22, 2023. If any comments or objections raise significant 
issues regarding any findings of fact or conclusions of law upon which 
this rule is based, the Administrator will withdraw this direct final 
rule and will issue a new rule, after she has reconsidered the issues 
in light of the comments and objections filed.
    Written comments must be postmarked and electronic comments must be 
submitted on or before November 22, 2023. 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-1118'' on all correspondence, including any 
attachments.
    <bullet> 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 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.
    <bullet> 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/DPW, 8701 
Morrissette Drive, Springfield, Virginia 22152.

FOR FURTHER INFORMATION CONTACT: Terrence L. Boos, Ph.D., Diversion 
Control Division, Drug Enforcement Administration; Telephone: (571) 
362-3249.

SUPPLEMENTARY INFORMATION: Any interested person may file comments or 
objections to this order, on or before November 22, 2023. If any such 
comments or objections raise significant issues regarding any findings 
of fact or conclusions of law upon which the rule is based, the 
Administrator will withdraw this direct final rule. The Administrator 
may reconsider the application in light of the comments and objections 
filed and reinstate, terminate, or amend the original order as deemed 
appropriate.

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. Such information includes personal identifying

[[Page 72681]]

information (such as your name, address, etc.) voluntarily submitted by 
the commenter.
    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. If a comment has so much confidential 
business information that it cannot be effectively redacted, all or 
part of that comment may not be posted on http://www.regulations.gov. 
Personal identifying information and confidential business information 
identified and located as set forth above will be redacted and the 
comment, in redacted form, will be posted online and placed in the Drug 
Enforcement Administration's (DEA) public docket file. Please note that 
the Freedom of Information Act applies to all comments received.

New Exempt Chemical Mixtures

    The manufacturers of nine chemical mixtures listed below have 
applied for an exemption pursuant to 21 CFR 1310.13. DEA has reviewed 
the applications, as well as any additional information submitted by 
the respective manufacturers. DEA has found that: (1) each of these 
chemical mixtures is formulated in such a way that it cannot be easily 
used in the illicit production of a controlled substance; and (2) the 
listed chemical(s) contained in these chemical mixtures cannot be 
readily recovered. Therefore, DEA has determined that each of the 
applications should be granted, and previously issued a letter to this 
effect. This regulatory action conforms DEA regulations to the 
exemptions previously issued.

Background

    Under 21 CFR 1310.13(a), the Administrator may, by publication of a 
final rule in the Federal Register, exempt from the application of all 
or any part of the Controlled Substances Act (CSA) a chemical mixture 
consisting of two or more chemical components, at least one of which is 
not a list I or list II chemical. Each manufacturer must apply for such 
an exemption (21 CFR 1310.13) to ensure that each manufacturer's 
product warrants an exemption by demonstrating that:
    (1) The mixture is formulated in such a way that it cannot be 
easily used in the illicit production of a controlled substance; and
    (2) The listed chemical or chemicals contained in the chemical 
mixture cannot be readily recovered.
    Any manufacturer seeking an exemption for a chemical mixture, not 
automatically exempt under 21 CFR 1310.12, may apply to the 
Administrator by submitting an application for exemption which contains 
the information required by 21 CFR 1310.13(c):
    (1) The name, address, and registration number, if any, of the 
applicant;
    (2) The date of the application;
    (3) The exact trade name(s) of the applicant's chemical mixture;
    (4) The complete qualitative and quantitative composition of the 
chemical mixture (including all listed and all non-listed chemicals); 
or if a group of mixtures, the concentration range for the listed 
chemical and a listing of all non-listed chemicals with respective 
concentration ranges;
    (5) The chemical and physical properties of the mixture and how 
they differ from the properties of the listed chemical or chemicals; 
and if a group of mixtures, how the group's properties differ from the 
properties of the listed chemical;
    (6) A statement that the applicant believes justifies an exemption 
for the chemical mixture or group of mixtures. The statement must 
explain how the chemical mixture(s) meets the exemption criteria;
    (7) A statement that the applicant accepts the right of the 
Administrator to terminate exemption from regulation for the chemical 
mixture(s) granted exemption under 21 CFR 1310.13; and
    (8) The identification of any information on the application that 
is considered by the applicant to be a trade secret or confidential and 
entitled to protection under U.S. laws restricting the public 
disclosure of such information.
    The Administrator may require the applicant to submit such 
additional documents or written statements of fact relevant to the 
application that he deems necessary for determining if the application 
should be granted.
    21 CFR 1310.13 further specifies that within a reasonable period of 
time after the receipt of an application for an exemption, the 
Administrator will notify the applicant of acceptance or rejection of 
the application for filing. If the application is not accepted for 
filing, an explanation will be provided. The Administrator is not 
required to accept an application if any information required pursuant 
to 21 CFR 1310.13 is lacking or not readily understood. The applicant 
may, however, amend the application to meet the requirements of this 
section.
    If the exemption is granted, the applicant shall be notified in 
writing and the Administrator shall issue, and publish in the Federal 
Register, an order on the application. This order shall specify the 
date on which it shall take effect. The Administrator shall permit any 
interested person to file written comments on or objections to the 
order. If any comments or objections raise significant issues regarding 
any findings of fact or conclusions of law upon which the order is 
based, the Administrator may suspend the effectiveness of the order 
until he has reconsidered the application in light of the comments and 
objections filed. Thereafter, the Administrator shall reinstate, 
terminate, or amend the original order as deemed appropriate.
    A formulation granted exemption by publication in the Federal 
Register will not be exempted for all manufacturers. The current Table 
of Exempt Chemical Mixtures lists those products that have been granted 
exempt status prior to this update. That table can be viewed online at: 
http://www.deadiversion.usdoj.gov/schedules/exempt/exempt_list.htm.

Findings

    Having considered the information provided in each of the below 
listed applications, I find that each of the referenced chemical 
mixtures meets the requirements for exemption under 21 CFR 1310.13(a). 
Therefore, each of these mixtures is exempt from the application of 
sections 302, 303, 310, 1007, and 1008 of the CSA (21 U.S.C. 822, 823, 
830, 957 and 958).
    DEA is updating the table in 21 CFR 1310.13(i) to include each of 
these exempt chemical mixtures.

Regulatory Analyses

Administrative Procedure Act

    An agency may find good cause to exempt a rule from prior public 
notice provisions of the Administrative Procedure Act (5 U.S.C. 
553(b)(B)), if it

[[Page 72682]]

is determined to be unnecessary, impracticable, or contrary to the 
public interest. DEA finds that it is unnecessary to engage in notice 
and comment procedures because this rulemaking grants exemptions for 
the below listed products in accordance with standards set by existing 
DEA regulations. Each of these manufacturers has previously received a 
letter from DEA granting exempted status for the specific products. 
This regulatory action hereby conforms DEA regulations to the 
exemptions previously considered and issued.

Executive Orders 12866 and 13563, Regulatory Planning and Review, 
Improving Regulation and Regulatory Review, and Reducing Regulation and 
Controlling Regulatory Costs

    This direct final rule was developed in accordance with the 
principles of Executive Orders (E.O.) 12866 and 13563. E.O. 12866 
directs agencies to assess all costs and benefits of available 
regulatory alternatives and, if regulation is necessary, to select 
regulatory approaches that maximize net benefits (including potential 
economic, environmental, public health, and safety effects; 
distributive impacts; and equity). E.O. 13563 is supplemental to and 
reaffirms the principles, structures, and definitions governing 
regulatory review as established in E.O. 12866. E.O. 12866 classifies a 
``significant regulatory action,'' requiring review by the Office of 
Management and Budget (OMB), as any regulatory action that is likely to 
result in a rule that may: (1) have an annual effect on the economy of 
$100 million or more or adversely affect in a material way the economy, 
a sector of the economy, productivity, competition, jobs, the 
environment, public health or safety, or State, local, or tribal 
governments or communities; (2) create a serious inconsistency or 
otherwise interfere with an action taken or planned by another agency; 
(3) materially alter the budgetary impact of entitlements, grants, user 
fees, or loan programs or the rights and obligations of recipients 
thereof; or (4) raise novel legal or policy issues arising out of legal 
mandates, the President's priorities, or the principles set forth in 
the E.O. DEA has determined that this direct final rule is not a 
``significant regulatory action'' under E.O. 12866, section 3(f).

Executive Order 12988, Civil Justice Reform

    The Administrator further certifies that this rulemaking meets the 
applicable standards set forth in sections 3(a) and 3(b)(2) of E.O. 
12988 to eliminate drafting errors and ambiguity, minimize litigation, 
provide a clear legal standard for affected conduct, and promote 
simplification and burden reduction.

Executive Order 13132, Federalism

    This rulemaking does not have federalism implications warranting 
the application of E.O. 13132. The rule does not have substantial 
direct effects on the States, on the relationship between the national 
government and the States, or the distribution of power and 
responsibilities among the various levels of government.

Executive Order 13175, Consultation and Coordination With Indian Tribal 
Governments

    This rule does not have tribal implications warranting the 
application of E.O. 13175. It does not have substantial direct effects 
on one or more Indian tribes, on the relationship between the Federal 
Government and Indian tribes, or on the distribution of power and 
responsibilities between the Federal Government and Indian tribes.

Regulatory Flexibility Act

    The Administrator hereby certifies that this rulemaking has been 
drafted in accordance with the Regulatory Flexibility Act (5 U.S.C. 
601-612), and by approving it certifies that this regulation will not 
have a significant economic impact upon a substantial number of small 
entities. This regulation will not have a significant impact upon firms 
who distribute these products. In fact, the approval of Exempt Chemical 
Mixture status for these products reduces the regulatory requirements 
for distribution of these materials.

Unfunded Mandates Reform Act of 1995

    In accordance with the Unfunded Mandates Reform Act (UMRA) of 1995, 
2 U.S.C. 1501 et seq., the DEA has determined that this action will not 
result in any Federal mandate that may result ``in the expenditure by 
State, local and tribal governments, in the aggregate, or by the 
private sector, of $100,000,000 or more (adjusted for inflation) in any 
one year. Therefore, neither a Small Government Agency Plan nor any 
other action is required under UMRA of 1995.

Paperwork Reduction Act of 1995

    This action does not impose a new collection of information 
requirement under the Paperwork Reduction Act of 1995. 44 U.S.C. 3501-
3521. This action does not impose recordkeeping or reporting 
requirements on State or local governments, individuals, businesses, or 
organizations. An agency may not conduct or sponsor, and a person is 
not required to respond to, a collection of information unless it 
displays a currently valid OMB control number.

Congressional Review Act

    This rule is not a major rule as defined by the Congressional 
Review Act (CRA), 5 U.S.C. 804. However, pursuant to the CRA, DEA is 
submitting a copy of this direct final rule to both Houses of Congress 
and to the Comptroller General.

Signing Authority

    This document of the Drug Enforcement Administration was signed on 
October 16, 2023, by Administrator Anne Milgram. That document with the 
original signature and date is maintained by DEA. For administrative 
purposes only, and in compliance with requirements of the Office of the 
Federal Register, the undersigned DEA Federal Register Liaison Officer 
has been authorized to sign and submit the document in electronic 
format for publication, as an official document of DEA. This 
administrative process in no way alters the legal effect of this 
document upon publication in the Federal Register.

List of Subjects in 21 CFR Part 1310

    Drug traffic control, Exports, Imports, Reporting and recordkeeping 
requirements.

Scott Brinks,
Federal Register Liaison Officer, Drug Enforcement Administration.
    Under the authority vested in the Attorney General by section 
102(39)(A)(vi) of the Act (21 U.S.C. 802(39)(A)(vi)) and delegated to 
the Administrator of the Drug Enforcement Administration by regulations 
of the Department of Justice (28 CFR 0.100), the Administrator hereby 
amends 21 CFR part 1310 as set forth below.

PART 1310--RECORDS AND REPORTS OF LISTED CHEMICALS AND CERTAIN 
MACHINES

0
1. The authority citation for part 1310 continues to read as follows:

    Authority: 21 U.S.C. 802, 827(h), 830, 871(b), 890.


0
2. In Sec.  1310.13, table 1 to paragraph (i) is amended by adding the 
following entries in alphabetical order by Manufacturer to read as 
follows:


Sec.  1310.13  Exemption of chemical mixtures; application.

* * * * *
    (i) * * *

[[Page 72683]]



                               Table 1 to Paragraph (i)--Exempt Chemical Mixtures
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              Manufacturer                     Product name \1\                  Form              Approval date
----------------------------------------------------------------------------------------------------------------
 
                                                  * * * * * * *
Dr. Haces, L.L.C........................  PodoPhylis, Podiatric       Polyurethane Iodine Insole      12/15/2021
                                           Insole.
 
                                                  * * * * * * *
Mitsubishi Chemical Corporation.........  Aquamicron AKX............  Liquid....................      04/08/2021
Mitsubishi Chemical Corporation.........  Aquamicron AS.............  Liquid....................      04/08/2021
Mitsubishi Chemical Corporation.........  Aquamicron Titrant SS 1 mg  Liquid....................      04/08/2021
Mitsubishi Chemical Corporation.........  Aquamicron Titrant SS 3 mg  Liquid....................      04/08/2021
Mitsubishi Chemical Corporation.........  Aquamicron Titrant SS 10    Liquid....................      04/08/2021
                                           mg.
Mitsubishi Chemical Corporation.........  Aquamicron Titrant SS-Z 1   Liquid....................      09/01/2020
                                           mg.
Mitsubishi Chemical Corporation.........  Aquamicron Titrant SS-Z 3   Liquid....................      09/01/2020
                                           mg.
Mitsubishi Chemical Corporation.........  Aquamicron Titrant SS-Z 5   Liquid....................      04/08/2021
                                           mg.
 
                                                  * * * * * * *
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\1\ Designate product line if a group.

[FR Doc. 2023-23315 Filed 10-20-23; 8:45 am]
BILLING CODE 4410-09-P