Rule2023-23315
Additions to Listing of Exempt Chemical Mixtures
Primary source
Metadata and text below are from the Federal Register, a public-domain U.S. government work. Always verify the official published version before relying on it for any legal matter.
Published
October 23, 2023
Effective
December 22, 2023
Issuing agencies
Justice DepartmentDrug Enforcement Administration
Abstract
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.
Full Text
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<title>Federal Register, Volume 88 Issue 203 (Monday, October 23, 2023)</title>
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[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 [<a href="http://www.gpo.gov">www.gpo.gov</a>]
[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 <a href="http://www.regulations.gov">http://www.regulations.gov</a>
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
<a href="http://Regulations.gov">Regulations.gov</a>. 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 <a href="http://www.regulations.gov">http://www.regulations.gov</a>. 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 <a href="http://www.regulations.gov">http://www.regulations.gov</a>.
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:
<a href="http://www.deadiversion.usdoj.gov/schedules/exempt/exempt_list.htm">http://www.deadiversion.usdoj.gov/schedules/exempt/exempt_list.htm</a>.
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
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</html>Indexed from Federal Register on October 23, 2023.
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