Additions to Listing of Exempt Chemical Mixtures, 72680-72683 [2023-23315]
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Federal Register / Vol. 88, No. 203 / Monday, October 23, 2023 / Rules and Regulations
PART 24—CUSTOMS FINANCIAL AND
ACCOUNTING PROCEDURE
1. The general authority citation for
part 24 continues to read as follows:
■
Authority: 5 U.S.C. 301; 19 U.S.C. 58a–
58c, 66, 1202 (General Note 3(i), Harmonized
Tariff Schedule of the United States), 1505,
1520, 1624; 26 U.S.C. 4461, 4462; 31 U.S.C.
3717, 9701; Pub. L. 107–296, 116 Stat. 2135
(6 U.S.C. 1 et seq.).
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2. Revise § 24.3(e) to read as follows:
§ 24.3
Bills and accounts; receipts.
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(e) Except for bills resulting from
dishonored payments (e.g., a check or
Automated Clearinghouse (ACH)
transaction), all other bills for duties,
taxes, fees, interest, or other charges are
due and payable within 30 days of the
date of the issuance of the bill. Bills
resulting from dishonored payments are
due and payable within 15 days of the
date of the issuance of the bill.
■ 3. In § 24.3a:
■ a. Revise the first sentence of the
introductory text of paragraph (b)(2)(i);
■ b. Remove paragraph (b)(2)(i)(C); and
■ c. Add a new paragraph (b)(3).
The revision and addition read as
follows:
§ 24.3a CBP bills; interest assessment on
bills; delinquency; notice to principal and
surety.
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(b) * * *
(2) * * *
(i) Initial interest accrual. Except as
otherwise provided in paragraphs
(b)(2)(i)(A) and (b)(2)(i)(B) of this
section, interest assessed due to an
underpayment of duties, taxes, fees, or
interest will accrue from the date the
importer of record is required to deposit
estimated duties, taxes, fees, and
interest to the date of liquidation or
reliquidation of the applicable entry or
reconciliation. * * *
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(3) Interest accrual on debit vouchers.
If a depository bank notifies CBP by a
debit voucher that a CBP account is
being debited due to a dishonored
payment (e.g., a check or Automated
Clearinghouse (ACH) transaction),
interest will accrue on the debited
amount from the date of the bill
resulting from the dishonored payment.
If payment is not received by CBP on or
before the late payment date appearing
on the bill, interest charges will be
assessed on the debited amount. The
initial late payment date is the date 15
days after the interest computation date.
The interest computation date is the
date from which interest is calculated
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and is initially the bill date. No interest
charge will be assessed where the
payment is actually received at the
‘‘Send Payment To’’ location designated
on the bill within the initial 15-day
period. After the initial 15-day period,
interest will be assessed in 30-day
periods pursuant to paragraph (c) of this
section.
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Robert F. Altneu,
Director, Regulations & Disclosure Law
Division, Regulations & Rulings, Office of
Trade, U.S. Customs and Border Protection.
Thomas C. West, Jr.,
Deputy Assistant Secretary of the Treasury
for Tax Policy.
[FR Doc. 2023–23305 Filed 10–20–23; 8:45 am]
BILLING CODE 9111–14–P
DEPARTMENT OF JUSTICE
Drug Enforcement Administration
21 CFR Part 1310
[Docket No. DEA–1118]
Additions to Listing of Exempt
Chemical Mixtures
Drug Enforcement
Administration, Department of Justice.
ACTION: Direct final rule.
AGENCY:
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
SUMMARY:
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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.
• 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 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
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/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 https://
www.regulations.gov. Such information
includes personal identifying
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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 https://
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
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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
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72681
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: https://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
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Federal Register / Vol. 88, No. 203 / Monday, October 23, 2023 / Rules and Regulations
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.
ambiguity, minimize litigation, provide
a clear legal standard for affected
conduct, and promote simplification
and burden reduction.
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.
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.
Congressional Review Act
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 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.
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.
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
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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
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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
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
1. The authority citation for part 1310
continues to read as follows:
■
Authority: 21 U.S.C. 802, 827(h), 830,
871(b), 890.
2. In § 1310.13, table 1 to paragraph (i)
is amended by adding the following
entries in alphabetical order by
Manufacturer to read as follows:
■
§ 1310.13 Exemption of chemical mixtures;
application.
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(i) * * *
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Federal Register / Vol. 88, No. 203 / Monday, October 23, 2023 / Rules and Regulations
TABLE 1 TO PARAGRAPH (i)—EXEMPT CHEMICAL MIXTURES
Manufacturer
Product name 1
Form
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Dr. Haces, L.L.C ......................................
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PodoPhylis, Podiatric Insole ...................
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Polyurethane Iodine Insole .....................
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Mitsubishi Chemical
Mitsubishi Chemical
Mitsubishi Chemical
Mitsubishi Chemical
Mitsubishi Chemical
Mitsubishi Chemical
Mitsubishi Chemical
Mitsubishi Chemical
*
Aquamicron
Aquamicron
Aquamicron
Aquamicron
Aquamicron
Aquamicron
Aquamicron
Aquamicron
Liquid
Liquid
Liquid
Liquid
Liquid
Liquid
Liquid
Liquid
*
Corporation
Corporation
Corporation
Corporation
Corporation
Corporation
Corporation
Corporation
*
1 Designate
.............
.............
.............
.............
.............
.............
.............
.............
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AKX .....................................
AS .......................................
Titrant SS 1 mg ...................
Titrant SS 3 mg ...................
Titrant SS 10 mg ................
Titrant SS–Z 1 mg ..............
Titrant SS–Z 3 mg ..............
Titrant SS–Z 5 mg ..............
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BILLING CODE 4410–09–P
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04/08/2021
04/08/2021
04/08/2021
04/08/2021
04/08/2021
09/01/2020
09/01/2020
04/08/2021
*
410–57–2596, email
MDNCRMarineEvents@uscg.mil.
DEPARTMENT OF HOMELAND
SECURITY
The Coast
Guard will enforce the safety zone
regulation for a fireworks display at The
Wharf DC from 8:30 p.m. to 10 p.m. on
October 25, 2023. This action is being
taken to provide for the safety of life on
navigable waterways during this event.
Our regulation for Fireworks Displays
within the Fifth Coast Guard District,
§ 165.506, specifies the location of the
safety zone for the fireworks show,
which encompasses portions of the
Washington Channel in the Upper
Potomac River. During the enforcement
period, as reflected in § 165.506(b), if
you are the operator of a vessel in the
vicinity of the safety zone, you may not
enter, remain in, or transit through the
safety zone unless authorized to do so
by the COTP or his representative, and
you must comply with directions from
the Patrol Commander or any Official
Patrol displaying a Coast Guard ensign.
In addition to this notification of
enforcement in the Federal Register, the
Coast Guard plans to provide
notification of this enforcement period
via the Local Notice to Mariners and
marine information broadcasts.
Coast Guard
SUPPLEMENTARY INFORMATION:
DEPARTMENT OF HOMELAND
SECURITY
Coast Guard
33 CFR Part 165
[Docket No. USCG–2023–0837]
Safety Zone; Fireworks Displays
Within the Fifth Coast Guard District
Coast Guard, DHS.
ACTION: Notification of enforcement of
regulation.
AGENCY:
The Coast Guard will enforce
a safety zone for a fireworks display at
The Wharf DC on October 25, 2023, to
provide for the safety of life on
navigable waterways during this event.
Our regulation for Fireworks Displays
within the Fifth Coast Guard District
identifies the safety zone for this event
in Washington, DC. During the
enforcement period, vessels may not
enter, remain in, or transit through the
safety zone unless authorized to do so
by the COTP or his representative, and
vessels in the vicinity must comply with
directions from the Patrol Commander
or any Official Patrol displaying a Coast
Guard ensign.
DATES: The regulation in 33 CFR
165.506 will be enforced for the location
identified in line no. 1 of table 2 to 33
CFR 165.506(h)(2) from 8:30 p.m. until
10 p.m. on October 25, 2023.
FOR FURTHER INFORMATION CONTACT: If
you have questions about this
notification of enforcement, call or
email MST2 Hollie Givens, Sector
Maryland-NCR, Waterways Management
Division, U.S. Coast Guard: telephone
SUMMARY:
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12/15/2021
product line if a group.
[FR Doc. 2023–23315 Filed 10–20–23; 8:45 am]
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15:49 Oct 20, 2023
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Dated: October 18, 2023.
David E. O’Connell,
Captain, U.S. Coast Guard, Captain of the
Port, Sector Maryland-National Capital
Region.
[FR Doc. 2023–23376 Filed 10–20–23; 8:45 am]
BILLING CODE 9110–04–P
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33 CFR Part 165
[Docket Number USCG–2023–0769]
RIN 1625–AA87
Security Zone; Watson Bayou, Panama
City, FL
Coast Guard, DHS.
Temporary final rule.
AGENCY:
ACTION:
The Coast Guard is
establishing a temporary security zone
for navigable waters of Watson Bayou,
Panama City FL, within an area bound
by the following points: 30°08′17.8″ N,
85°38′6.6″ W (Diamond Point), thence
northeast toward 30°08′34.6″ N,
85°37′55.7″ W (Eastern Shipbuilding),
thence east to the South East Avenue
Bridge. The security zone is needed to
protect the official party, the public, and
the surrounding waterway from terrorist
acts, sabotage or other subversive acts,
accidents, or other causes of a similar
nature. Entry of vessels or persons into
this zone is prohibited unless
specifically authorized by the Sector
Mobile Captain of the Port (COTP).
DATES: This rule is effective from 1:30
p.m. on October 27, 2023, through 5
p.m. on November 27, 2023.
ADDRESSES: To view documents
mentioned in this preamble as being
available in the docket, go to https://
www.regulations.gov, type USCG–2023–
0769 in the search box and click
‘‘Search.’’ Next, in the Document Type
column, select ‘‘Supporting & Related
Material.’’
SUMMARY:
If
you have questions about this rule, call
or email MSTC Stacy Stevenson,
FOR FURTHER INFORMATION CONTACT:
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]]>Agencies
[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.
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 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 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/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 https://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 https://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:
https://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
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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.
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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.
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(i) * * *
[[Page 72683]]
Table 1 to Paragraph (i)--Exempt Chemical Mixtures
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Manufacturer Product name \1\ Form Approval date
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* * * * * * *
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
