[Federal Register Volume 88, Number 72 (Friday, April 14, 2023)]
[Proposed Rules]
[Pages 22955-22962]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2023-07454]


=======================================================================
-----------------------------------------------------------------------

DEPARTMENT OF JUSTICE

Drug Enforcement Administration

21 CFR Part 1310

[Docket No. DEA-1098]


Designation of Halides of 4-Anilinopiperidine as List I Chemicals

AGENCY: Drug Enforcement Administration, Department of Justice.

ACTION: Notice of proposed rulemaking.

-----------------------------------------------------------------------

SUMMARY: The Drug Enforcement Administration is proposing to modify the 
listing of the list I chemical, N-phenylpiperidin-4-amine (also known 
as 4-anilinopiperidine; N-phenyl-4-piperidinamine; 4-AP) (hereinafter 
referred to as 4-anilinopiperidine), to include halides of 4-
anilinopiperidine. The current listing of 4-anilinopiperidine includes 
its amides, its carbamates, and its salts, as list I chemicals under 
the Controlled Substances Act. The Drug Enforcement Administration 
proposes the new listing to read as follows: N-phenylpiperidin-4-amine 
(4-anilinopiperidine; N-phenyl-4-piperidinamine; 4-AP), its amides, its 
carbamates, its halides, its salts, and any combination thereof, 
whenever the existence of such is possible, as a list I chemical under 
the Controlled Substances Act.

DATES: Comments must be submitted electronically or postmarked on or 
before May 15, 2023. Commenters should be aware that the electronic 
Federal Docket Management System will not accept any 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-1098'' on all electronic and written correspondence, 
including any attachments.
     Electronic comments: The Drug Enforcement Administration 
encourages that all comments be submitted electronically through the 
Federal eRulemaking Portal which provides the ability to type short 
comments directly into the comment field on the web page or attach a 
file for lengthier comments. Please go to 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 electronic 
submissions are not necessary. 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, Drug and Chemical 
Evaluation Section, Diversion Control Division, Drug Enforcement 
Administration; Telephone: (571) 362-3249.

SUPPLEMENTARY INFORMATION:

Posting of Public Comments

    Please note that all comments received in response to this docket 
are considered part of the public record. They will, unless reasonable 
cause is given, be made available by the Drug Enforcement 
Administration (DEA) for public inspection online at https://www.regulations.gov. Such information includes personal identifying 
information (such as your name, address, etc.) voluntarily submitted by 
the commenter. The Freedom of Information Act applies to all comments 
received. If you want to submit personal identifying information (such 
as your name, address, etc.) as part of your comment, but do not want 
it to be made publicly available, you must include the phrase 
``PERSONAL IDENTIFYING INFORMATION'' in the first paragraph of your 
comment. You must also place all of the personal identifying 
information you do not want made publicly available in the first 
paragraph of your comment and identify what information you want 
redacted.
    If you want to submit confidential business information as part of 
your comment, but do not want it to be made publicly available, you 
must include the phrase ``CONFIDENTIAL BUSINESS INFORMATION'' in the 
first paragraph of your comment. You must also prominently identify the 
confidential business information to be redacted within the comment.
    Comments containing personal identifying information or 
confidential business information identified as directed above will 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 https://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 proposed rule is available at https://www.regulations.gov for easy reference.

Legal Authority

    The Controlled Substances Act (CSA) gives the Attorney General the 
authority to specify, by regulation, chemicals as list I chemicals.\1\ 
A ``list I chemical'' is a chemical that is used in manufacturing a 
controlled substance in violation of the CSA and is important to the 
manufacture of the controlled substances.\2\ The current list of all 
listed chemicals is published at 21 CFR 1310.02. Pursuant to 28 CFR 
0.100(b), the Attorney General has delegated his authority to designate 
list I chemicals to the Administrator of DEA (Administrator). DEA 
regulations set forth the process by which DEA may add a chemical as a 
listed chemical. As set forth in 21 CFR 1310.02(c), the agency may do 
so by publishing a final rule in the Federal Register following a 
published notice of proposed rulemaking with at least 30 days for 
public comments.
---------------------------------------------------------------------------

    \1\ 21 U.S.C. 802(34).
    \2\ Id.
---------------------------------------------------------------------------

Background

    DEA previously found that 4-anilinopiperidine is used in the 
illicit manufacture of the controlled substance fentanyl (a schedule II 
substance under the CSA) and fentanyl analogues controlled in schedule 
I of the CSA, and is important to the manufacture of the controlled 
substance fentanyl and fentanyl analogues, because it cannot be 
replaced by other chemicals in its respective synthetic pathways that 
are used in the illicit manufacture of

[[Page 22956]]

fentanyl and fentanyl analogues.\3\ On this basis, DEA previously 
specified that 4-anilinopiperidine is a list I chemical.\4\ DEA has now 
found that halides of 4-anilinopiperidine are also used in the illicit 
manufacture of schedule I controlled substances, such as para-
fluorofentanyl, ortho-fluorofentanyl, and para-chlorofentanyl. 
Accordingly, if finalized, this action would add halides of 4-
anilinopiperidine to the prior listing of 4-anilinopiperidine and 
thereby subject handlers of halides of 4-anilinopiperidine to the 
chemical regulatory provisions of the CSA and its implementing 
regulations.
---------------------------------------------------------------------------

    \3\ 85 FR 20822 (Apr. 15, 2020).
    \4\ Id.
---------------------------------------------------------------------------

    This proposed rule would not affect current handlers of 4-
anilinopiperidine, including its amides, its carbamates, and its salts, 
as they would already be registered to handle 4-anilinopiperidine. This 
rulemaking does not establish a threshold for domestic and 
international transactions of halides of 4-anilinopiperidine. As such, 
all transactions of chemical mixtures containing halides of 4-
anilinopiperidine will be regulated at any concentration and will be 
subject to control under the CSA.
    Fentanyl is a synthetic opioid and was first synthesized in Belgium 
in the late 1950s. Fentanyl was introduced into medical practice and is 
approved for medical practitioners in the United States to prescribe 
lawfully for anesthesia and analgesia. Yet, due to its pharmacological 
effects, fentanyl can be used as a substitute for heroin, oxycodone, 
and other opioids. Therefore, despite its accepted medical use in 
treatment in the United States, the DEA controls fentanyl as a schedule 
II controlled substance due to its high potential for abuse and 
dependence.\5\
---------------------------------------------------------------------------

    \5\ 21 U.S.C. 812(c), Schedule II(b)(6); 21 CFR 1308.12(c).
---------------------------------------------------------------------------

    The unlawful trafficking and distribution of fentanyl and fentanyl 
analogues in the United States continues to pose an imminent hazard to 
public safety. Since 2012, fentanyl has shown a dramatic increase in 
the illicit drug supply as a single substance, in mixtures with other 
illicit drugs (i.e., heroin, cocaine, and methamphetamine), or in forms 
that mimic pharmaceutical preparations, including prescription opiates 
and benzodiazepines.\6\
---------------------------------------------------------------------------

    \6\ United Nations Office on Drugs and Crime, Global SMART 
Update Volume 17, March 2017. https://www.unodc.org/documents/scientific/Global_SMART_Update_17_web.pdf.
---------------------------------------------------------------------------

    In recent years, the United States has experienced a significant 
increase in overdoses and overdose fatalities from fentanyl and 
fentanyl analogues. According to the Centers for Disease Control and 
Prevention (CDC), drug-induced overdose deaths involving synthetic 
opioids (excluding methadone) in the United States increased from 
36,359 in 2019, to 56,516 in 2020, and to 70,589 in 2021 
(provisional).\7\ Further, CDC reports that opioids, mainly synthetic 
opioids (which includes fentanyl), are predominately responsible for 
drug overdose fatalities, as the drug overdose death data (109,247) 
predicted for the 12 month-ending March 2022, synthetic opioids were 
involved in about 67.3 percent of all drug-induced overdose deaths.\8\
---------------------------------------------------------------------------

    \7\ Centers for Disease Control and Prevention, National Center 
for Health Statistics. National Vital Statistics System, Provisional 
Mortality on CDC WONDER Online Database. Data are from the final 
Multiple Cause of Death Files, 2018-2020, and from provisional data 
for years 2021-2022, as compiled from data provided by the 57 vital 
statistics jurisdictions through the Vital Statistics Cooperative 
Program. Accessed at https://wonder.cdc.gov/mcd-icd10-provisional.html on August 15, 2022.
    \8\ Ahmad FB, Rossen LM, Sutton P. Provisional drug overdose 
death counts. National Center for Health Statistics. 2021. Accessed 
at https://www.cdc.gov/nchs/nvss/vsrr/drug-overdose-data.htm on May 
5, 2022.
---------------------------------------------------------------------------

    The increase in overdose fatalities involving synthetic opioids 
coincides with a dramatic increase in law enforcement encounters of 
fentanyl and fentanyl analogues. According to the National Forensic 
Laboratory Information System (NFLIS-Drug),\9\ reports from forensic 
laboratories of drug items containing fentanyl and several schedule I 
fentanyl analogues increased dramatically since 2014, as shown in Table 
1.
---------------------------------------------------------------------------

    \9\ The National Forensic Laboratory Information System (NFLIS-
Drug) is a national forensic laboratory reporting system that 
systematically collects results from drug chemistry analyses 
conducted by Federal, State and local forensic laboratories in the 
United States. While NFLIS-Drug data is not direct evidence of 
abuse, it can lead to an inference that a drug has been diverted and 
abused. See 76 FR 77330, 77332 (Dec. 12, 2011). NFLIS-Drug data was 
queried on August 15, 2022.

                          Table 1--Annual Reports of Fentanyl and Halogenated Fentanyl Analogues Identified in Drug Encounters
--------------------------------------------------------------------------------------------------------------------------------------------------------
                      Year                            2014         2015         2016         2017         2018         2019         2020         2021
--------------------------------------------------------------------------------------------------------------------------------------------------------
Fentanyl........................................        5,553       15,461       37,144       61,628       89,890      107,928      124,773      156,629
Halogenated Fentanyl Analogues \10\.............            1           10          435        2,628        2,960        1,013          743       19,831
--------------------------------------------------------------------------------------------------------------------------------------------------------

Role of 4-Anilinopiperidine in the Synthesis of Fentanyl and Fentanyl 
Analogues

    Fentanyl and its analogues are not naturally occurring substances. 
As such, the manufacture of these substances requires them to be 
produced through synthetic organic chemistry. Synthetic organic 
chemistry is the process in which a new organic molecule is created 
through a series of chemical reactions, which involve precursor 
chemicals. Through chemical reactions, the chemical structures of 
precursor chemicals are modified in a desired fashion. These chemical 
reaction sequences, also known as synthetic pathways, are designed to 
create a desired substance. Several synthetic pathways to fentanyl and 
fentanyl analogues have been identified in clandestine laboratory 
settings, including the original ``Janssen method,'' the ``Siegfried 
method,'' and the ``Gupta method,'' which are further explained below.
    In response to the illicit manufacture of fentanyl using these 
methods, DEA controlled N-phenethyl-4-piperidone (NPP); \11\ N-(1-
benzylpiperidin-4-yl)-N-phenylpropionamide (benzylfentanyl), N-
phenylpiperidin-4-amine (4-anilinopiperidine); \12\ and proposed 
control of 4-piperidone \13\ as list I chemicals. DEA also controlled 
4-anilino-N-phenethylpiperidine

[[Page 22957]]

(ANPP) \14\ and N-phenyl-N-(piperidin-4-yl)propionamide (norfentanyl) 
\15\ as schedule II immediate precursors to fentanyl under the CSA.
---------------------------------------------------------------------------

    \10\ Halogenated fentanyl analogues reported to NFLIS-Drug 
include: meta-fluorofentanyl, meta-fluoroisobutyryl fentanyl, para-
fluoroisobutyryl fentanyl, chlorofentanyl, fluoro furanyl fentanyl, 
fluorobutyryl fentanyl, fluorobutyryl/fluoroisobutyryl fentanyl, 
fluorofentanyl, fluoroisobutyryl fentanyl, meta-fluoro furanyl 
fentanyl, ortho-fluorobutyryl fentanyl, ortho-fluoroisobutyryl 
fentanyl, ortho-fluoro acrylfentanyl, ortho-fluoro furanyl fentanyl, 
ortho-fluorofentanyl, ortho-chlorofentanyl, para-chlorofentanyl, 
para-fluoro furanyl fentanyl, para-fluoro valeryl fentanyl, para-
fluorobutyryl fentanyl, and para-fluorofentanyl.
    \11\ 72 FR 20039 (Apr. 23, 2007).
    \12\ 85 FR 20822 (Apr. 15, 2020).
    \13\ 87 FR 57852 (Sept. 22, 2022).
    \14\ 75 FR 37295 (Aug. 30, 2010).
    \15\ 85 FR 21320 (Apr. 17, 2020).
---------------------------------------------------------------------------

    In 2017, the United Nations Commission on Narcotic Drugs (CND) 
placed NPP and ANPP in Table I of the Convention Against Illicit 
Traffic in Narcotic Drugs and Psychotropic Substances of 1988 (1988 
Convention) in response to the international reintroduction of fentanyl 
on the illicit drug market.\16\ As such, member states of the United 
Nations were required to regulate these precursor chemicals at the 
national level. In addition, the People's Republic of China regulated 
NPP and ANPP on February 1, 2018.\17\
---------------------------------------------------------------------------

    \16\ 60th Session of the CND Dec/60/12 (ANPP) and Dec/60/13 
(NPP).
    \17\ https://www.dea.gov/press-release/2018/01/05/china-announces-scheduling-controls-two-fentanyl-precursor-chemicals. 
Accessed March 9, 2022.
---------------------------------------------------------------------------

    Following the international control of NPP and ANPP under the 1988 
Convention, illicit fentanyl manufacturers moved to unregulated 
precursor chemicals. These included 4-anilinopiperidine, 1-boc-4-AP, 
and norfentanyl. In response, the CND placed 4-anilinopiperidine, 1-
boc-4-AP, and norfentanyl in Table I of the 1988 Convention.\18\
---------------------------------------------------------------------------

    \18\ In a letter dated May 27, 2022, the United Nations Office 
on Drugs and Crime, in accordance with Article 12, paragraph 6 of 
the 1988 Convention, informed the Permanent Mission of the United 
States of America to the United Nations (Vienna) that the CND 
decided to place the chemical 4-AP in Table I of the 1988 Convention 
(CND Dec/65/4) and the chemical 1-boc-4-AP in Table I of the 1988 
Convention (CND Dec/65/5) at its 65th Session on March 16, 2022.
---------------------------------------------------------------------------

    On May 15, 2020, 4-anilinopiperidine became a list I chemical in 
the United States due to its role in the illicit manufacture of 
fentanyl.\19\ Since that control action, DEA has observed an increase 
in identifications of certain fentanyl analogues by law enforcement and 
public health officials. Many of these fentanyl analogues contain a 
halogen atom on the aniline ring of its respective chemical structure. 
The presence of the halogen atom suggests that the fentanyl analogue 
was synthesized from a halogenated precursor chemical. Indeed, 
halogenated fentanyl precursors have been identified by law 
enforcement, such as tert-butyl 4-((4-fluorophenyl)amino)piperidine-1-
carboxylate (para-fluoro 1-boc 4-AP). The chemical structure of this 
precursor defines it as a halide and carbamate of 4-anilinopiperidine. 
As such, it falls outside of the current definitions of a list I 
chemical, simply due to the presence of the fluorine (a halogen) atom. 
Although it is not regulated as a list I chemical, it can be used in 
the synthesis of fentanyl analogues, such as the schedule I substances 
para-fluorofentanyl, para-fluoroisobutyryl fentanyl, para-fluorobutyryl 
fentanyl, and para-fluoro furanyl fentanyl.
---------------------------------------------------------------------------

    \19\ 85 FR 20822 (April 15, 2020).
---------------------------------------------------------------------------

    In addition, fentanyl analogues with both meta- and ortho-fluoro 
substitutions have been identified, such as ortho-fluorofuranyl 
fentanyl and meta-fluorofuranyl fentanyl. The identification of these 
substances suggests illicit fentanyl analogue manufacturers attempt to 
utilize unregulated precursor chemicals to evade law enforcement 
detection and precursor chemical controls. This strategy allows for the 
synthesis of a variety of fentanyl analogues by simply moving the 
fluorine atom around the aniline ring while maintaining the same 
synthetic methodology used to synthesize fentanyl and fentanyl 
analogues.
    Likewise, other halogenated fentanyl analogues, such as those 
containing a chlorine atom, have been reported by forensic 
laboratories. According to NFLIS-Drug, para-chlorofentanyl and ortho-
chlorofentanyl were reported for the first time in 2020. The 
identification of these substances suggests that illicit fentanyl 
analogue manufacturers utilize precursor chemicals containing a 
chlorine atom as an alternative to a fluorine atom in effort to evade 
law enforcement detection.

4-Anilinopiperidine

    The original published synthetic pathway to fentanyl, known as the 
Janssen method, involves the two important precursors, benzylfentanyl 
and norfentanyl. 4-Piperidone,\20\ a chemical proposed for list I 
control under the CSA, serves as a precursor chemical to 
benzylfentanyl, a list I chemical under the CSA,\21\ which is converted 
to norfentanyl, the schedule II immediate precursor in this synthetic 
pathway. Norfentanyl is then subjected to one simple chemical reaction 
to complete the synthesis of fentanyl. Norfentanyl is controlled in 
schedule II of the CSA.\22\
---------------------------------------------------------------------------

    \20\ 87 FR 57852 (Sept. 22, 2022).
    \21\ 85 FR 20822 (Apr. 15, 2020).
    \22\ 85 FR 21320 (Apr. 17, 2020).
---------------------------------------------------------------------------

    Like the Janssen method, 4-piperidone serves as an early-stage 
precursor chemical in the Siegfried method. 4-Piperidone is a precursor 
to NPP, a known fentanyl precursor and list I chemical under the 
CSA,\23\ in the Siegfried method. NPP is then converted to ANPP, the 
schedule II immediate precursor in this synthetic pathway. ANPP is then 
subjected to a simple one-step chemical reaction to complete the 
synthesis of fentanyl. ANPP is controlled as a schedule II immediate 
precursor under the CSA.\24\
---------------------------------------------------------------------------

    \23\ 72 FR 20039 (Apr. 23, 2007).
    \24\ 75 FR 37295 (Aug. 30, 2010).
---------------------------------------------------------------------------

    In addition to the Janssen and Siegfried methods, clandestine 
manufacturers are using other methods to synthesize fentanyl, one of 
which is known as the Gupta method. 4-Anilinopiperidine, a list I 
chemical under the CSA,\25\ is the key precursor in the Gupta method. 
4-Anilinopiperidine serves as an alternative precursor chemical to NPP 
in the synthesis of ANPP, albeit through a different synthetic process. 
The resulting ANPP is then used as the immediate precursor chemical in 
the illicit manufacture of fentanyl.
---------------------------------------------------------------------------

    \25\ 85 FR 20822 (Apr. 15, 2020).
---------------------------------------------------------------------------

    Recent encounters of precursor chemicals related to 4-
anilinopiperidine in chemical structure have occurred. These precursor 
chemicals contain a halogen atom on the aniline ring of 4-
anilinopiperidine. Modifications have included the addition of a 
fluorine atom, a chlorine atom, or a bromine atom at different 
positions on the aniline ring of the 4-anilinopiperidine structure. The 
use of these halogenated 4-anilinopiperidine precursor chemicals in 
place of 4-anilinopiperidine has resulted in the illicit manufacturing 
of schedule I fentanyl analogues.
    Halogenated 4-anilinopiperidines \26\ are commercially available 
from both domestic and foreign suppliers. DEA is aware of at least 25 
domestic suppliers and 14 foreign suppliers. Substituted versions of 4-
anilinopiperidine, such as para-fluoro 1-boc-4-AP, are attractive to 
illicit manufacturers because they are readily available from chemical 
suppliers and the lack of regulations on these substituted precursor 
chemicals.
---------------------------------------------------------------------------

    \26\ Chemicals included the folowing: ortho-fluoro 4-AP, ortho-
chloro 4-AP, ortho-bromo 4-AP, meta-fluoro 4-AP, meta-chloro 4-AP, 
meta-bromo 4-AP, para-fluoro 4-AP, para-chloro 4-AP, para-bromo 4-
AP, ortho-fluoro 1-boc-4-AP, ortho-chloro 1-boc-4-AP, ortho-bromo 1-
boc-4-AP, meta-fluoro 1-boc-4-AP, meta-chloro 1-boc-4-AP, meta-bromo 
1-boc-4-AP, para-fluoro 1-boc-4-AP, para-chloro 1-boc-4-AP, and 
para-bromo 1-boc-4-AP.

---------------------------------------------------------------------------

[[Page 22958]]

    para-Fluoro 1-boc-4-AP has been identified in law enforcement 
encounters in the United States. According to NFLIS-Drug, beginning in 
2020, there have been at least nine reports of para-fluoro 1-boc-4-AP 
from forensic laboratories in the United States. A query of DEA's 
STARLiMS \27\ database provided 16 reports of para-fluoro 1-boc-4-AP 
from analyses conducted on submitted drug evidence by DEA forensic 
laboratories. Of these 16 reports, para-fluoro 1-boc-4-AP was the only 
substance reported in nine exhibits (totaling more than 29 kg), 
suggesting that these seizures were intended to be used as precursor 
chemicals in the synthesis of fentanyl analogues. Additionally, para-
fluoro 1-boc-4-AP was reported in combination with para-fluorofentanyl 
in four of the seven exhibits containing a mixture of substances, 
suggesting that para-fluoro 1-boc-4-AP was a precursor chemical 
involved in the synthesis of para-fluorofentanyl, a schedule I 
substance under the CSA.
---------------------------------------------------------------------------

    \27\ On October 1, 2014, DEA implemented STARLiMS (a web-based, 
commercial laboratory information management system) to replace the 
System to Retrieve Information from Drug Evidence (STRIDE) as its 
laboratory drug evidence data system of record. STARLiMS data was 
queried on September 12, 2022.
---------------------------------------------------------------------------

    As of August 2022, in addition to domestic encounters, the 
International Narcotics Control Board of the United Nations reported 
two international transactions of para-fluoro 1-boc-4-AP through the 
Precursors Incident Communication System (PICS) \28\ reporting system. 
These incidents reported to PICS totaled approximately 51 kg and had 
destinations located in North America.
---------------------------------------------------------------------------

    \28\ PICS is a platform that allows governments to exchange 
operational and investigative intelligence and to generate strategic 
intelligence on precursors trafficking. PICS reports were collected 
up to August 23, 2022.
---------------------------------------------------------------------------

    These recent law enforcement encounters of para-fluoro 1-boc-4-AP 
coincide with the placement of NPP, ANPP, 4-anilinopiperidine, 1-boc-4-
AP (tert-butyl 4-(phenylamino)piperidine-1-carboxylate), and 
norfentanyl in Table I of the 1988 Convention, the People's Republic of 
China regulating NPP and ANPP as of February 1, 2018, and the 
regulation of benzylfentanyl and proposed control of 4-piperidone as 
list I chemicals in the United States. The domestic encounters of para-
fluoro 1-boc-4-AP at ports of entry indicate a change in precursors 
used in the illicit manufacture of fentanyl to substituted precursor 
chemicals used in the illicit manufacture of fentanyl analogues in 
efforts to evade international controls on NPP, ANPP, 4-
anilinopiperidine, 1-boc-4-AP, and norfentanyl and additional controls 
on benzylfentanyl in the United States.

Regulation of 4-Anilinopiperidine, Including Its Amides, Its 
Carbamates, Its Halides, Its Salts, and Any Combination Thereof, 
Whenever the Existence of Such Is Possible, as a List I Chemical

    The CSA, specifically 21 U.S.C. 802(34), and its implementing 
regulations at 21 CFR 1310.02(c), provide the Attorney General with the 
authority to specify, by regulation, additional precursor or essential 
chemicals as listed chemicals if they are used in the manufacture of 
controlled substances in violation of the CSA. Recent law enforcement 
encounters indicate halides of 4-anilinopiperidine are being used in 
the illicit manufacture of schedule I fentanyl analogues. This proposed 
rule would modify the current regulations that regulate 4-
anilinopiperidine, including its amides, its carbamates, and its salts 
to include halides of 4-anilinopiperidine. DEA finds that 4-
anilinopiperidine, including its amides, its carbamates, its halides, 
its salts, and any combination thereof, whenever the existence of such 
is possible, is used in the illicit manufacture of controlled 
substances, such as fentanyl and fentanyl analogues, and is important 
to the manufacture of these substances because it cannot be replaced by 
other chemicals in their respective synthetic pathways that are used in 
the illicit manufacture of fentanyl and fentanyl analogues.

Chemical Mixtures of 4-Anilinopiperidine

    This proposed rulemaking, if finalized, would modify the current 
regulations that regulate 4-anilinopiperidine, including its amides, 
its carbamates, and its salts to include halides of 4-
anilinopiperidine. The regulations would specify that chemical mixtures 
containing halides of 4-anilinopiperidine would not be exempt from 
regulatory requirements at any concentration, unless an application for 
exemption of a chemical mixture is submitted by a manufacturer of 
halides of 4-anilinopiperidine and the application is reviewed and 
accepted by DEA under 21 CFR 1310.13 (Exemption by Application 
Process). The control of chemical mixtures containing any amount of 
halides of 4-anilinopiperidine is necessary to prevent the extraction, 
isolation, and use of halides of 4-anilinopiperidine in the illicit 
manufacture of schedule I fentanyl analogues. This proposed rule would 
modify the Table of Concentration Limits in 21 CFR 1310.12(c) to 
reflect the fact that chemical mixtures containing any amount of 4-
anilinopiperidine, including its amides, its carbamates, its halides, 
its salts, and any combination thereof, whenever the existence of such 
is possible, are subject to the CSA chemical control provisions.

Exemption by Application Process

    DEA has implemented an application process to exempt mixtures from 
the requirements of the CSA and its implementing regulations.\29\ Under 
the application process, manufacturers may submit an application for 
exemption for those mixtures that do not qualify for automatic 
exemption. Exemption status can be granted if DEA determines that the 
mixture is formulated in such a way that it cannot be easily used in 
the illicit production of a controlled substance and that the listed 
chemical cannot be readily recovered.\30\
---------------------------------------------------------------------------

    \29\ 21 CFR 1310.13.
    \30\ 21 U.S.C. 802(39)(A)(vi).
---------------------------------------------------------------------------

Requirements for Handling List I Chemicals

    On May 15, 2020, DEA regulated 4-anilinopiperidine, including its 
amides, its carbamates, and its salts, as a list I chemical under the 
CSA. This proposed rule would expand the definitions of 4-
anilinopiperidine to include its halides. Halides of 4-
anilinopiperidine would become subject to the regulatory provisions of 
the CSA upon publication of a final rule. Chemicals that meet the 
current definition of 4-anilinopiperidine \31\ have been, and continue 
to be, subject to the regulatory provisions of the CSA since May 15, 
2020.
---------------------------------------------------------------------------

    \31\ 85 FR 20822.
---------------------------------------------------------------------------

    If this rule is finalized as proposed, halides of 4-
anilinopiperidine will be subject to all of the regulatory controls and 
administrative, civil, and criminal sanctions applicable to the 
manufacture, distribution, importing, and exporting of list I 
chemicals, just as 4-anilinopiperidine, including its amides, its 
carbamates, and its salts are currently regulated. Upon publication of 
a final rule, persons potentially handling halides of 4-
anilinopiperidine, including regulated chemical mixtures containing 
halides of 4-anilinopiperidine, will be required to comply with list I 
chemical regulations, including the following:
    1. Registration. Any person who manufactures, distributes, imports, 
or exports halides of 4-anilinopiperidine, including chemical mixtures 
containing halides of 4-anilinopiperidine, or

[[Page 22959]]

proposes to engage in the manufacture, distribution, importation, or 
exportation of halides of 4-anilinopiperidine, including chemical 
mixtures containing halides of 4-anilinopiperidine, must obtain a 
registration pursuant to 21 U.S.C. 822, 823, 957, and 958. Regulations 
describing registration for list I chemical handlers are set forth in 
21 CFR part 1309. DEA regulations require separate registrations for 
manufacturing, distributing, importing, and exporting of list I 
chemicals.\32\ Further, a separate registration is required for each 
principal place of business at one general physical location where list 
I chemicals are manufactured, distributed, imported, or exported by a 
person.\33\
---------------------------------------------------------------------------

    \32\ 21 CFR 1309.21.
    \33\ 21 U.S.C. 822(e)(1); 21 CFR 1309.23(a).
---------------------------------------------------------------------------

    DEA notes that under the CSA, ``warehousemen'' are not required to 
register and may lawfully possess list I chemicals, if the possession 
of those chemicals is in the usual course of business or employment. 
Under DEA implementing regulations, the warehouse in question must 
receive the list I chemical from a DEA registrant and shall only 
distribute the list I chemical back to the DEA registrant and 
registered location from which it was received. A warehouse that 
distributes list I chemicals to persons other than the registrant and 
registered location from which they were obtained is conducting 
distribution activities and is required to register as such.
    Upon publication of a final rule, any person manufacturing, 
distributing, importing, or exporting halides of 4-anilinopiperidine or 
a chemical mixture containing halides of 4-anilinopiperidine would 
become subject to the registration requirement under the CSA. DEA 
recognizes, however, that it is not possible for persons who are 
subject to the registration requirements to immediately complete and 
submit an application for registration, and for DEA to immediately 
issue registrations for those activities. Therefore, to allow any 
continued legitimate commerce in halides of 4-anilinopiperidine or a 
chemical mixture containing halides of 4-anilinopiperidine, DEA is 
proposing to update the listing in 21 CFR 1310.09(p), to include the 
proposed updated definitions of 4-anilinopiperidine to include a 
temporary exemption from the registration requirement for persons 
desiring to engage in activities with the proposed updated definitions 
of halides of 4-anilinopiperidine or a chemical mixture containing 
halides of 4-anilinopiperidine, provided that DEA receives a properly 
completed application for registration or application for exemption of 
a chemical mixture under 21 CFR 1310.13 on or before 30 days after 
publication of a final rule implementing regulations regarding the 
proposed updated definitions of 4-anilinopiperidine. The temporary 
exemption for such persons will remain in effect until DEA takes final 
action on their application for registration or application for 
exemption of a chemical mixture.
    The temporary exemption applies solely to the registration 
requirement; all other chemical control requirements, including 
recordkeeping and reporting, would become effective on the effective 
date of the final rule. This is necessary because a delay in regulating 
these transactions could result in increased diversion of chemicals 
desirable to drug traffickers.
    Additionally, the temporary exemption for registration does not 
suspend applicable Federal criminal laws relating to halides of 4-
anilinopiperidine, nor does it supersede State or local laws or 
regulations. All handlers of halides of 4-anilinopiperidine must comply 
with applicable State and local requirements in addition to the CSA 
regulatory controls.
    2. Records and Reports. Every DEA registrant would be required to 
maintain records and submit reports with respect to halides of 4-
anilinopiperidine pursuant to 21 U.S.C. 830 and in accordance with 21 
CFR part 1310.04 and 1310.05. Pursuant to 21 CFR 1310.04, a record must 
be kept for two years after the date of a transaction involving a 
listed chemical, provided the transaction is a regulated transaction.
    The CSA and its implementing regulations require that each 
regulated person must report to DEA any regulated transaction involving 
an extraordinary quantity of a listed chemical, an uncommon method of 
payment or delivery, or any other circumstance that the regulated 
person believes may indicate that the listed chemical will be used in 
violation of subchapter I of the CSA. In addition, regulated persons 
must report any proposed regulated transaction with a person whose 
description or other identifying characteristics DEA has previously 
furnished to the regulated person, any unusual or excessive loss or 
disappearance of a listed chemical under the control of the regulated 
person, and any in-transit loss in which the regulated person is the 
supplier. 21 U.S.C. 830(b); 21 CFR 1310.05(a) and (b).
    3. Importation and Exportation. All importation and exportation of 
halides of 4-anilinopiperidine or a chemical mixture containing halides 
of 4-anilinopiperidine would need to be done in compliance with 21 
U.S.C. 957, 958, and 971, and in accordance with 21 CFR part 1313.
    4. Security. All applicants and registrants would be required to 
provide effective controls against theft and diversion of list I 
chemicals in accordance with 21 CFR 1309.71-1309.73.
    5. Administrative Inspection. Places, including factories, 
warehouses, or other establishments and conveyances, where registrants 
or other regulated persons may lawfully hold, manufacture, distribute, 
or otherwise dispose of a list I chemical or where records relating to 
those activities are maintained, are controlled premises as defined in 
21 U.S.C. 880(a) and 21 CFR 1316.02(c). The CSA allows for 
administrative inspections of these controlled premises as provided in 
21 CFR part 1316, subpart A.\34\
---------------------------------------------------------------------------

    \34\ 21 U.S.C. 880.
---------------------------------------------------------------------------

    6. Liability. Any activity involving halides of 4-anilinopiperidine 
not authorized by, or in violation of, the CSA, would be unlawful, and 
would subject the person to administrative, civil, and/or criminal 
action.

Solicitation for Information

    As part of this proposed rulemaking, DEA is soliciting information 
on any possible legitimate uses of halides of 4-anilinopiperidine 
unrelated to fentanyl production (including industrial uses) in order 
to assess the potential economic impact of controlling halides of 4-
anilinopiperidine as defined in this proposed rule. DEA has searched 
information in the public domain for legitimate uses of this chemical, 
and has not documented a legitimate commercial or industrial use for 
halides of 4-anilinopiperidine. DEA seeks, however, to document any 
unpublicized use(s) and other proprietary use(s) of halides of 4-
anilinopiperidine that are not in the public domain. Therefore, DEA is 
soliciting comment on the uses of halides of 4-anilinopiperidine in the 
legitimate marketplace.
    DEA is soliciting input from all potentially affected parties 
regarding: (1) The types of legitimate industries using halides of 4-
anilinopiperidine; (2) the legitimate uses of halides of 4-
anilinopiperidine, if any; (3) the size of the domestic market for 
halides of 4-anilinopiperidine; (4) the number of manufacturers of 
halides of 4-anilinopiperidine; (5) the number of

[[Page 22960]]

distributors of halides of 4-anilinopiperidine; (6) the level of import 
and export of halides of 4-anilinopiperidine; (7) the potential burden 
these proposed regulatory controls of halides of 4-anilinopiperidine 
may have on any legitimate trade; (8) the potential number of 
individuals/firms that may be adversely affected by these proposed 
regulatory controls (particularly with respect to the impact on small 
businesses); and (9) any other information on the manner of 
manufacturing, distribution, consumption, storage, disposal, and uses 
of halides of 4-anilinopiperidine by industry and others. DEA invites 
all interested parties to provide any information on any legitimate 
uses of halides of 4-anilinopiperidine in industry, commerce, academia, 
research and development, or other applications. DEA seeks both 
quantitative and qualitative data.

Handling of Confidential or Proprietary Information

    Confidential or proprietary information may be submitted as part of 
a comment regarding this Notice of Proposed Rulemaking. Please see the 
``POSTING OF PUBLIC COMMENTS'' section above for a discussion of the 
identification and redaction of confidential business information and 
personally identifying information.

Regulatory Analyses

Executive Orders 12866 and 13563, Regulatory Planning and Review, 
Improving and Regulation and Regulatory Review

    This proposed 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.
    A review of the 25 domestic suppliers of halides of 4-
anilinopiperidine indicates that these entities are not registered with 
DEA to handle list I chemicals. These 25 suppliers are entities that do 
not also supply 4-anilinopiperidine as these entities would already be 
registered to handle list I chemicals since 4-anilinopiperidine is 
currently a list I chemical under the CSA. Therefore, the modified 
definitions of 4-anilinopiperidine in this proposed rule would 
potentially affect 25 entities. DEA anticipates that this proposed rule 
will impose minimal or no economic impact on affected entities; and 
thus, will not have a significant economic impact on any of the 25 
affected small entities. Therefore, DEA concludes this proposed rule is 
not a significant regulatory action under E.O. 12866. If finalized as 
proposed, halides of 4-anilinopiperidine will be subject to all of the 
regulatory controls and administrative, civil, and criminal sanctions 
applicable to the manufacture, distribution, importing, and exporting 
of list I chemicals, just as 4-anilinopiperidine, including its amides, 
its carbamates, and its salts, is currently regulated. 4-
Anilinopiperidine is a precursor chemical used in, and is important to, 
the illicit manufacture of the schedule II controlled substance 
fentanyl and schedule I fentanyl analogues. The distribution of 
illicitly manufactured fentanyl and fentanyl analogues has caused an 
unprecedented outbreak of thousands of fentanyl-related overdoses in 
the United States in recent years.
    DEA has searched information in the public domain for any 
legitimate uses of halides of 4-anilinopiperidine, and has not 
documented a use for halides of 4-anilinopiperidine. DEA welcomes any 
public comment on these quantities and their economic significance.
    DEA evaluated the costs and benefits of this proposed action.
Costs
    DEA believes the market for halides of 4-anilinopiperidine for the 
legitimate manufacturing of pharmaceutical fentanyl is minimal because 
halides of 4-anilinopiperidine are not used to synthesize fentanyl or 
any schedule II fentanyl analogue currently used in medical practice. 
As stated above, DEA is not aware of any legitimate uses of halides of 
4-anilinopiperidine. Any manufacturer, distributor, importer, or 
exporter of halides of 4-anilinopiperidine, if they exist at all, would 
incur costs if this proposed rule were finalized. The primary costs 
associated with this proposed rule would be the annual registration 
fees for list I chemicals ($3,699 for manufacturers and $1,850 for 
distributors, importers, and exporters). However, DEA believes that the 
cost will be minimal.
    DEA has identified 25 domestic suppliers of halides of 4-
anilinopiperidine. None of these 25 suppliers are registered to handle 
list I chemicals. It is difficult to estimate the quantity of 
distribution of halides of 4-anilinopiperidine by these suppliers. It 
is common for chemical distributors to have items in their catalog 
while not actually having any material level of sales. If this proposed 
rule is finalized, suppliers for the legitimate use of halides of 4-
anilinopiperidine are expected to choose the least-cost option, and 
stop selling the minimal quantities, if any, of halides of 4-
anilinopiperidine, rather than incur the registration cost. Because DEA 
believes the quantities of halides of 4-anilinopiperidine supplied for 
the legitimate manufacturing of pharmaceutical fentanyl are minimal, 
DEA estimates that the cost of foregone sales is minimal; thus, the 
cost of this proposed rule is minimal. DEA welcomes any public comment 
regarding this estimate.
    This analysis excludes consideration of any economic impact to 
those businesses that facilitate the manufacturing and distribution of 
halides of 4-anilinopiperidine for the manufacturing of illicit 
fentanyl and fentanyl analogues. As a law enforcement organization and 
as a matter of principle, DEA believes considering the economic utility 
of facilitating the manufacture of illicit fentanyl would be improper.
Benefits
    Controlling halides of 4-anilinopiperidine is expected to prevent, 
curtail, and limit the unlawful manufacture and distribution of 
fentanyl and fentanyl analogues. As a list I chemical, handling of 
halides of 4-anilinopiperidine would require registration with DEA and 
various controls and monitoring as required by the CSA. This proposed 
rule is also expected to assist preventing the

[[Page 22961]]

possible theft or diversion of halides of 4-anilinopiperidine from any 
legitimate firms. DEA also believes control is necessary to prevent 
unscrupulous chemists from synthesizing halides of 4-anilinopiperidine 
and selling them (as unregulated materials) through the internet and 
other channels, to individuals who may wish to acquire unregulated 
intermediary chemicals for the purpose of illicitly manufacturing 
fentanyl and fentanyl analogues.
    In summary, DEA conducted a qualitative analysis of costs and 
benefits. DEA believes this proposed action, if finalized, will 
minimize the diversion of halides of 4-anilinopiperidine. DEA believes 
the market for halides of 4-anilinopiperidine for the legitimate 
manufacturing of fentanyl or schedule II fentanyl analogues currently 
used in medical practice is minimal since halides of 4-
anilinopiperidine are not used to synthesize fentanyl or any schedule 
II fentanyl analogue currently used in medical practice. Therefore, any 
potential cost as a result of this regulation is minimal.

Executive Order 12988, Civil Justice Reform

    This proposed regulation meets the applicable standards set forth 
in sections 3(a) and 3(b)(2) of E.O. 12988 Civil Justice Reform 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 proposed rulemaking does not have federalism implications 
warranting the application of E.O. 13132. The proposed 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 proposed rule does not have tribal implications warranting the 
application of E.O. 13175. This proposed rule 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, in accordance with the Regulatory Flexibility 
Act (5 U.S.C. 601-612), has reviewed this proposed rule and by 
approving it certifies that it will not have a significant economic 
impact on a substantial number of small entities. As discussed above, 
if finalized as proposed, halides of 4-anilinopiperidine or a chemical 
mixture containing halides of 4-anilinopiperidine will be subject to 
all of the regulatory controls and administrative, civil, and criminal 
sanctions applicable to the manufacture, distribution, importing, and 
exporting of list I chemicals. Halides of 4-anilinopiperidine are 
precursor chemicals used in, and important to, the illicit manufacture 
of the schedule I fentanyl analogues. The distribution of illicitly 
manufactured fentanyl and fentanyl analogues has caused an 
unprecedented outbreak of thousands of fentanyl-related overdoses in 
the United States in recent years. DEA has not identified any 
legitimate industrial use for halides of 4-anilinopiperidine. 
Therefore, DEA believes the vast majority, if not all, of halides of 4-
anilinopiperidine is used for the illicit manufacturing of schedule I 
fentanyl analogues. The primary costs associated with this proposed 
rule are the annual registration fees ($3,699 for manufacturers and 
$1,850 for distributors, importers, and exporters). DEA has identified 
25 domestic suppliers of halides of 4-anilinopiperidineall of which are 
not registered with DEA to handle list I chemicals. All non-registered 
domestic suppliers are affected and are estimated to be small entities 
(based on Small Business Administration size standard for chemical 
distributors and Statistics of U.S. Business data).\35\ It is 
impossible to know how much halides of 4-anilinopiperidine is 
distributed by these suppliers. It is common for chemical distributors 
to have items in their catalog while not actually having any material 
level of sales. Therefore, DEA estimates the cost of this proposed rule 
on any affected small entity is minimal. DEA welcomes any public 
comment regarding this estimate. Based on these factors, DEA projects 
that this proposed rule, if promulgated, will not result in a 
significant economic impact on a substantial number of small entities.
---------------------------------------------------------------------------

    \35\ https://www.sba.gov/sites/default/files/2018-07/NAICS%202017%20Table%20of%20Size%20Standards.pdf.
---------------------------------------------------------------------------

Unfunded Mandates Reform Act of 1995

    On the basis of information contained in the ``Regulatory 
Flexibility Act'' section above, DEA has determined and certifies 
pursuant to the Unfunded Mandates Reform Act of 1995 (UMRA), 2 U.S.C. 
1501 et seq., that this action would 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 provisions of UMRA.

List of Subjects in 21 CFR Part 1310

    Administrative practice and procedure, Drug traffic control, 
Reporting and recordkeeping requirements.

    For the reasons set out above, DEA proposes to amend 21 CFR part 
1310 as follows:

PART 1310--RECORDS AND REPORTS OF LISTED CHEMICALS AND CERTAIN 
MACHINES; IMPORTATION AND EXPORTATION OF CERTAIN MACHINES

0
1. The authority citation for 21 CFR part 1310 continues to read as 
follows:

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

0
2. In Sec.  1310.02, revise paragraph (a)(33) to read as follows:


Sec.  1310.02  Substances covered.

* * * * *
    (a) * * *

(33) N-phenylpiperidin-4-amine (4-anilinopiperidine; N-phenyl-4-   8335
 piperidinamine; 4-AP), its amides, its carbamates, its halides,
 its salts, and any combination thereof, whenever the existence
 of such is possible............................................
 

* * * * *
0
3. In Sec.  1310.04, revise paragraph (g)(1)(xiii) to read as follows:


Sec.  1310.04  Maintenance of records.

* * * * *
    (g) * * *
    (1) * * *
    (xiii) N-phenylpiperidin-4-amine (4-anilinopiperidine; N-phenyl-4-

[[Page 22962]]

piperidinamine; 4-AP), its amides, its carbamates, its halides, its 
salts, and any combination thereof, whenever the existence of such is 
possible
* * * * *
0
4. In Sec.  1310.09, revise paragraph (p) to read as follows:


Sec.  1310.09  Temporary exemption from registration.

* * * * *
    (p)(1) Each person required under 21 U.S.C. 822 and 21 U.S.C. 957 
to obtain a registration to manufacture, distribute, import, or export 
regulated N-phenylpiperidin-4-amine (4-anilinopiperidine; N-phenyl-4-
piperidinamine; 4-AP), its amides, its carbamates, its halides, its 
salts, and any combination thereof, whenever the existence of such is 
possible, including regulated chemical mixtures pursuant to Sec.  
1310.12, is temporarily exempted from the registration requirement, 
provided that DEA receives a properly completed application for 
registration or application for exemption for a chemical mixture 
containing halides of 4-anilinopiperidine pursuant to Sec.  1310.13 on 
or before 30 days after the publication of a rule finalizing this 
action. The exemption would remain in effect for each person who has 
made such application until the Administration has approved or denied 
that application. This exemption applies only to registration; all 
other chemical control requirements set forth in the Act and parts 
1309, 1310, 1313, and 1316 of this chapter remain in full force and 
effect.
    (2) Any person who manufactures, distributes, imports, or exports a 
chemical mixture containing N-phenylpiperidin-4-amine (4-
anilinopiperidine; N-phenyl-4-piperidinamine; 4-AP), its amides, its 
carbamates, its halides, its salts, and any combination thereof, 
whenever the existence of such is possible, whose application for 
exemption is subsequently denied by DEA must obtain a registration with 
DEA. A temporary exemption from the registration requirement will also 
be provided for those persons whose application for exemption is 
denied, provided that DEA receives a properly completed application for 
registration on or before 30 days following the date of official DEA 
notification that the application for exemption has been denied. The 
temporary exemption for such persons will remain in effect until DEA 
takes final action on their registration application.
* * * * *
0
5. In Sec.  1310.12, in the table in paragraph (c), revise the entry 
for N-phenylpiperidin-4-amine to read as follows:


Sec.  1310.12  Exempt chemical mixtures.

* * * * *
    (c) * * *

                                          Table of Concentration Limits
----------------------------------------------------------------------------------------------------------------
                                          DEA chemical code
                                                number               Concentration          Special conditions
----------------------------------------------------------------------------------------------------------------
                                                List I Chemicals
----------------------------------------------------------------------------------------------------------------
 
                                                   * * * * * *
N-phenylpiperidin-4-amine (4-          8335...................  Not exempt at any        Chemical mixtures
 anilinopiperidine; N-phenyl-4-                                  concentration.           containing any amount
 piperidinamine; 4-AP), its amides,                                                       of 4-anilinopiperidine
 its carbamates, its halides, its                                                         are not exempt.
 salts, and any combination thereof,
 whenever the existence of such is
 possible.
 
                                                   * * * * * *
----------------------------------------------------------------------------------------------------------------

* * * * *

Signing Authority

    This document of the Drug Enforcement Administration was signed on 
April 3, 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 RegisterLiaison 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.

Scott Brinks,
Federal Register Liaison Officer, Drug Enforcement Administration.
[FR Doc. 2023-07454 Filed 4-13-23; 8:45 am]
BILLING CODE 4410-09-P