[Federal Register Volume 88, Number 209 (Tuesday, October 31, 2023)]
[Rules and Regulations]
[Pages 74352-74359]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2023-23927]


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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: Final rule.

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SUMMARY: The Drug Enforcement Administration (DEA) is finalizing the 
modification of 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. This rule finalizes the modification of 
the listing of 4-anilinopiperidine as a list I chemical.

DATES: This rule is effective November 30, 2023. Persons currently 
manufacturing, distributing, importing, or exporting halides of 4-
anilinopiperidine or a chemical mixture containing halides of 4-
anilinopiperidine, if they are not already registered to handle list I 
chemicals, must apply on or before November 30, 2023, to continue their 
business pending final action by DEA on their application.

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

SUPPLEMENTARY INFORMATION: The Drug Enforcement Administration (DEA) is 
extremely concerned with the recent increase in the illicit manufacture 
and distribution of fentanyl and fentanyl analogues. Therefore, on 
April 14, 2023, DEA published a Notice of Proposed Rulemaking (NPRM) to 
include halides of 4-anilinopiperidine as list I chemicals.\1\ This 
rulemaking finalizes that NPRM.
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    \1\ 88 FR 22955 (Apr. 14, 2023).
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    This action subjects handlers of halides of 4-anilinopiperidine to 
the regulatory provisions of the Controlled Substances Act (CSA) and 
its implementing regulations regarding list I chemicals. This 
rulemaking does not establish a threshold for domestic and 
international transactions of halides of 4-anilinopiperidine. As such, 
all transactions involving halides of 4-anilinopiperidine, regardless 
of size, shall be regulated and are subject to control under the CSA. 
In addition, chemical mixtures containing halides of 4-
anilinopiperidine are not exempt from regulatory requirements at any 
concentration. Therefore, all transactions of chemical mixtures 
containing any quantity of halides of 4-anilinopiperidine shall be 
regulated pursuant to the CSA as list I chemicals.

Legal Authority

    The CSA gives the Attorney General the authority to specify, by 
regulation, chemicals as list I chemicals.\2\ 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.\3\ The current list of all listed chemicals is 
published at 21 CFR 1310.02(a). 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). The 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.
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    \2\ 21 U.S.C. 802(34).
    \3\ Id.
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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 fentanyl and fentanyl 
analogues.\4\ On this basis, DEA previously specified that 4-
anilinopiperidine is a list I chemical.\5\
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    \4\ 85 FR 20822 (Apr. 15, 2020).
    \5\ Id.
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    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, this action adds halides of 4-anilinopiperidine to the 
prior listing of 4-anilinopiperidine and thereby subjects handlers of 
halides of 4-anilinopiperidine to the regulatory provisions of the CSA 
and its implementing regulations.

[[Page 74353]]

    This rule does not affect current handlers of 4-anilinopiperidine, 
including its amides, its carbamates, and its salts, as they are 
already required to be registered to handle 4-anilinopiperidine. This 
rule does not establish a threshold for domestic and international 
transactions of halides of 4-anilinopiperidine. As such, all 
transactions involving halides of 4-anilinopiperidine, regardless of 
size, shall be regulated as list I chemicals and are subject to control 
under the CSA. In addition, chemical mixtures containing halides of 4-
anilinopiperidine are not exempt from regulatory requirements at any 
concentration. Therefore, all transactions of chemical mixtures 
containing any quantity of halides of 4-anilinopiperidine shall be 
regulated as list I chemicals pursuant to 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.\6\
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    \6\ 21 U.S.C. 812(c), Schedule II(b)(6); 21 CFR 1308.12(c).
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    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.\7\
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    \7\ 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.
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    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).\8\ 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.\9\
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    \8\ 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.
    \9\ 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.
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    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),\10\ reports from forensic 
laboratories of drug items containing fentanyl and several schedule I 
fentanyl analogues increased dramatically since 2014, as shown in Table 
1.
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    \10\ 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
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                      Year                            2014         2015         2016         2017         2018         2019         2020         2021
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Fentanyl........................................        5,553       15,461       37,144       61,628       89,890      107,928      124,773      156,629
Halogenated Fentanyl Analogues \11\.............            1           10          435        2,628        2,960        1,013          743       19,831
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Role of 4-Anilinopiperidine in the Synthesis of Fentanyl and Fentanyl 
Analogues
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    \11\ 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.
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    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); \12\ N-(1-
benzylpiperidin-4-yl)-N-phenylpropionamide (benzylfentanyl), N-
phenylpiperidin-4-amine (4-anilinopiperidine); \13\ and 4-piperidone 
\14\ as list I chemicals. DEA also controlled 4-anilino-N-
phenethylpiperidine (ANPP) \15\ and N-phenyl-N-(piperidin-4-
yl)propionamide (norfentanyl) \16\ as schedule II immediate precursors 
to fentanyl under the CSA.
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    \12\ 72 FR 20039 (Apr. 23, 2007).
    \13\ 85 FR 20822 (Apr. 15, 2020).
    \14\ 88 FR 21902 (Apr. 12, 2023).
    \15\ 75 FR 37295 (Aug. 30, 2010).
    \16\ 85 FR 21320 (Apr. 17, 2020).
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    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

[[Page 74354]]

reintroduction of fentanyl on the illicit drug market.\17\ 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.\18\
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    \17\ 60th Session of the CND Dec/60/12 (ANPP) and Dec/60/13 
(NPP).
    \18\ https://www.dea.gov/press-release/2018/01/05/china-announces-scheduling-controls-two-fentanyl-precursor-chemicals. 
Accessed March 9, 2022.
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    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.\19\
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    \19\ 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.
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    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.\20\ 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 not previously 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.
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    \20\ 85 FR 20822 (April 15, 2020).
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    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,\21\ a list I chemical under the CSA, 
serves as a precursor chemical to benzylfentanyl, a list I chemical 
under the CSA,\22\ 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.\23\
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    \21\ 88 FR 21902 (Apr. 12, 2023).
    \22\ 85 FR 20822 (Apr. 15, 2020).
    \23\ 85 FR 21320 (Apr. 17, 2020).
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    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,\24\ 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.\25\
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    \24\ 72 FR 20039 (Apr. 23, 2007).
    \25\ 75 FR 37295 (Aug. 30, 2010).
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    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,\26\ 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.
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    \26\ 85 FR 20822 (Apr. 15, 2020).
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    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 \27\ are commercially available 
from both domestic and foreign suppliers. DEA is aware of at least 25 
domestic suppliers and 14 foreign suppliers. Modified 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 regulatory control on these substituted 
precursor chemicals.
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    \27\ 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.
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    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 \28\ 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

[[Page 74355]]

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.
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    \28\ 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.
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    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) \29\ reporting system. 
These incidents reported to PICS totaled approximately 51 kg and had 
destinations located in North America.
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    \29\ 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.
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    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 rule 
modifies the current listing of 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.

Comments Received

    As part of this rulemaking, DEA solicited 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 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 sought, 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 solicited comment on 
the uses of halides of 4-anilinopiperidine in the legitimate 
marketplace.
    DEA solicited 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 distributors of 
halides of 4-anilinopiperidine; (6) the level of import and export of 
halides of 4-anilinopiperidine; (7) the potential burden these 
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 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 invited 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 sought both quantitative and qualitative data. DEA 
did not receive any responses to these specific solicitations, nor did 
DEA receive any other comments in response to the NPRM.

Chemical Mixtures of 4-Anilinopiperidine

    This rulemaking modifies the current regulations for 4-
anilinopiperidine, including its amides, its carbamates, and its salts 
to include halides of 4-anilinopiperidine. The regulations specify that 
chemical mixtures containing halides of 4-anilinopiperidine are not 
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 rule 
modifies 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 as list 
I chemicals.

Exemption by Application Process

    DEA has implemented an application process to exempt mixtures from 
the requirements of the CSA and its implementing regulations.\30\ 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.\31\
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    \30\ 21 CFR 1310.13.
    \31\ 21 U.S.C. 802(39)(A)(vi).
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Requirements for Handling List I Chemicals

    On May 15, 2020, DEA promulgated regulations which listed 4-
anilinopiperidine, including its amides, its carbamates, and its salts, 
as a list I

[[Page 74356]]

chemical under the CSA. Chemicals that meet the current definition of 
4-anilinopiperidine \32\ have been, and continue to be, subject to the 
regulatory provisions of the CSA since May 15, 2020. This rule expands 
the definitions of 4-anilinopiperidine to include its halides. Halides 
of 4-anilinopiperidine become subject to the regulatory provisions of 
the CSA upon the effective date of this rule.
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    \32\ 85 FR 20822.
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    Upon the effective date of this final rule, 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 the effective 
date of this 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 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, if they are not already registered to handle 
list I chemicals. 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.\33\ 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.\34\
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    \33\ 21 CFR 1309.21.
    \34\ 21 U.S.C. 822(e)(1); 21 CFR 1309.23(a).
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    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.\35\ 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.\36\
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    \35\ 21 U.S.C. 822(c)(2).
    \36\ 21 U.S.C. 822(a)(1).
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    Upon the effective date of this final rule, any person 
manufacturing, distributing, importing, or exporting halides of 4-
anilinopiperidine or a chemical mixture containing halides of 4-
anilinopiperidine will become subject to the registration requirement 
under the CSA for list I chemicals. DEA recognizes, however, that it is 
not possible for persons who become subject to the registration 
requirements under this rule 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 updating the 
listing in 21 CFR 1310.09(p), to include a temporary exemption from the 
registration requirement for persons desiring to engage in activities 
with the 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 November 30, 2023. 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, will become effective on the effective 
date of this 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 must 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.
    Each regulated bulk manufacturer of a listed chemical must submit 
manufacturing, inventory, and use data on an annual basis. Existing 
standard industry reports containing the required information are 
acceptable, provided the information is separate or readily retrievable 
from the report.\37\
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    \37\ 21 CFR 1310.05(d).
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    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.\38\
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    \38\ 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 must 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 must 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

[[Page 74357]]

controlled premises as provided in 21 CFR part 1316, subpart A.\39\
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    \39\ 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.

Regulatory Analyses

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

    This final rule, which adds halides of 4-anilinopiperidine to the 
prior listing of the list I chemical 4-anilinopiperidine, was developed 
in accordance with the principles of Executive orders (E.O.) 12866, 
13563, and 14094. 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 $200 million or more (adjusted every 
three years by the Administrator of OIRA \40\ for changes in gross 
domestic product); 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, territorial, 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 legal or policy issues for which 
centralized review would meaningfully further the President's 
priorities or the principles set forth in the E.O., as specifically 
authorized in a timely manner by the Administrator of OIRA in each 
case.
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    \40\ Office of Information and Regulatory Affairs.
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    A review of the 25 domestic suppliers of halides of 4-
anilinopiperidine indicates that these entities are not currently 
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 required to register 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 
final rule would potentially affect 25 entities. DEA anticipates that 
this 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 rule 
is not a significant regulatory action under E.O. 12866. Upon the 
effective date of this final rule, 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 requested 
public comment regarding this estimate; however, no public comment was 
received during the notice and comment period.
    DEA evaluated the costs and benefits of this 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 will incur costs. The 
primary costs associated with this 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. Suppliers for 
the legitimate use of halides of 4-anilinopiperidine are expected to 
choose the least-cost option, and depending on the circumstances, some 
suppliers might choose to 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 rule is minimal. DEA 
requested public comment regarding this estimate; however, no public 
comment was received during the notice and comment period.
    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 requires registration with DEA and 
various controls and monitoring as required by the CSA. This rule is 
also expected to assist preventing the 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.

[[Page 74358]]

    In summary, DEA conducted a qualitative analysis of costs and 
benefits. DEA believes this action 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 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 rule 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. This 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 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, halides of 4-
anilinopiperidine or a chemical mixture containing halides of 4-
anilinopiperidine shall 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 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-
anilinopiperidine, all of which are not currently 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).\41\ 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 rule on any affected small entity is 
minimal. DEA did not receive public comment regarding this estimate. 
Based on these factors, DEA projects that this rule will not result in 
a significant economic impact on a substantial number of small 
entities.
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    \41\ https://www.sba.gov/sites/default/files/2018-07/NAICS%202017%20Table%20of%20Size%20Standards.pdf.
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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.

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 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 25, 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.

Scott Brinks,
Federal Register Liaison Officer, Drug Enforcement Administration.

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 amends 21 CFR part 1310 to read 
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) * * *

[[Page 74359]]



------------------------------------------------------------------------
 
------------------------------------------------------------------------
 
                              * * * * * * *
(33) N-phenylpiperidin-4-amine (4-anilinopiperidine; N-             8335
 phenyl-4-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)(xiv) to read as follows:


Sec.  1310.04  Maintenance of records.

* * * * *
    (g) * * *
    (1) * * *
    (xiv) 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.
* * * * *

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 November 30, 2023. 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 containing
 anilinopiperidine; N-phenyl-4-                           concentration.            any amount of 4-
 piperidinamine; 4-AP), its amides, its                                             anilinopiperidine are not
 carbamates, its halides, its salts,                                                exempt.
 and any combination thereof, whenever
 the existence of such is possible.
 
                                                  * * * * * * *
----------------------------------------------------------------------------------------------------------------

* * * * *
[FR Doc. 2023-23927 Filed 10-30-23; 8:45 am]
BILLING CODE 4410-09-P