[Federal Register Volume 85, Number 75 (Friday, April 17, 2020)]
[Rules and Regulations]
[Pages 21320-21325]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2020-07381]


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

DEPARTMENT OF JUSTICE

Drug Enforcement Administration

21 CFR Part 1308

[Docket No. DEA-496]


Control of the Immediate Precursor Norfentanyl Used in the 
Illicit Manufacture of Fentanyl as a Schedule II Controlled Substance

AGENCY: Drug Enforcement Administration, Department of Justice.

ACTION: Final rule.

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

SUMMARY: The Drug Enforcement Administration (DEA) is designating the 
precursor chemical, N-phenyl-N-(piperidin-4-yl)propionamide 
(norfentanyl) as an immediate precursor for the schedule II controlled 
substance fentanyl. Furthermore, DEA is finalizing the control of 
norfentanyl as a schedule II substance under the Controlled Substances 
Act (CSA).

DATES: This rulemaking becomes effective May 18, 2020.

FOR FURTHER INFORMATION CONTACT: Scott A. Brinks, Regulatory Drafting 
and Policy Support Section (DPW), Diversion Control Division, Drug 
Enforcement Administration; Mailing Address: 8701 Morrissette Drive, 
Springfield, Virginia 22152; Telephone: (571) 362-3261.

SUPPLEMENTARY INFORMATION: Norfentanyl is the immediate chemical 
intermediary in a synthesis process currently used by clandestine 
laboratory operators for the illicit manufacture of the schedule II 
controlled substance fentanyl. The distribution of illicitly 
manufactured fentanyl has caused an unprecedented outbreak of thousands 
of fentanyl-related overdoses in the United States in recent years. DEA 
believes that the control of norfentanyl as a schedule II controlled 
substance is necessary to prevent its diversion as an immediate 
chemical intermediary for the illicit manufacture of fentanyl.
    DEA is extremely concerned with the recent increase in the illicit 
manufacture and distribution of fentanyl. Therefore, on September 17, 
2019, DEA published a Notice of Proposed Rulemaking (NPRM) to designate 
the precursor chemical, N-phenyl-N-(piperidin-4-yl)propionamide 
(norfentanyl), as an immediate precursor of the schedule II controlled 
substance fentanyl under the definition set forth in 21 U.S.C. 802(23), 
and to control it as a schedule II substance under the CSA. 84 FR 
48815. This rulemaking finalizes that NPRM.

Legal Authority

    Under 21 U.S.C. 811(e), the Attorney General may place an immediate 
precursor into the same schedule as the controlled substance that the 
immediate precursor is used to make, if the substance meets the 
requirements of an immediate precursor under 21 U.S.C. 802(23).

Background

    The DEA is extremely concerned with the increase in the illicit 
manufacture and distribution of fentanyl abroad. Fentanyl is a 
synthetic opioid and was first synthesized in Belgium in the late 
1950's. Fentanyl is controlled in schedule II of the CSA due to its 
high potential for abuse and dependence, and accepted medical use in 
treatment in the United States. Fentanyl was introduced into medical 
practice and is approved in the United States for anesthesia and 
analgesia. However, due to its pharmacological effects, fentanyl can 
serve as a substitute for heroin, oxycodone, and other opioids in 
opioid dependent individuals. The trafficking of fentanyl in the United 
States continues to pose an imminent hazard to the 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.
    The DEA has noted a significant increase in overdoses and overdose 
fatalities from fentanyl in the United States in recent years. A recent 
report \1\ from the Centers for Disease Control and Prevention (CDC) 
highlights this trend. According to this report, of the 41,430 drug 
overdose deaths occurring in the United States in 2011, 1,662 (4.0 
percent) involved fentanyl.\2\ Of the 63,632 drug overdose deaths in 
2016, 18,335 (28.8 percent) involved fentanyl. This was the first time 
that fentanyl was reported in more drug related fatalities than heroin.
---------------------------------------------------------------------------

    \1\ Drugs Most Frequently Involved in Drug Overdose Deaths: 
United States, 2011-2016. National Vital Statistics Reports; vol 67 
no 9. Hyattsville, MD: National Center for Health Statistics, 2018.
    \2\ The fentanyl category includes fentanyl, fentanyl 
metabolites, precursors, and analogs.
---------------------------------------------------------------------------

    The increase of drug overdose deaths continued into 2017. According 
to the CDC,\3\ there were 70,237 drug overdose deaths in the United 
States in 2017, an increase from the 63,632 overdose deaths recorded in 
2016. Of the 70,237 overdose deaths in 2017, 47,600 (67.8 percent) 
involved an opioid. Deaths involving prescription opioids and heroin 
remained stable from 2016 to 2017; synthetic opioid overdose deaths 
(other than methadone), which include deaths related to fentanyl, 
increased 45.2 percent from 19,413 deaths in 2016 to 28,466 deaths in 
2017.
---------------------------------------------------------------------------

    \3\ Scholl L, Seth P, Kariisa M, Wilson N, Baldwin G. Drug and 
Opioid-Involved Overdose Deaths--United States, 2013-2017. MMWR Morb 
Mortal Wkly Rep 2019;67:1419-1427.
---------------------------------------------------------------------------

    The increase in overdose fatalities involving fentanyl coincides 
with a dramatic increase of law enforcement encounters of fentanyl. 
According to the National Forensic Laboratory Information System 
(NFLIS),\4\ submissions to forensic laboratories that contained 
fentanyl increased exponentially beginning in 2012: 694 in 2012, 1,044 
in 2013, 5,537 in 2014, 15,455 in 2015, 37,294 in 2016, 61,382 in 2017, 
and 70,453 in 2018.
---------------------------------------------------------------------------

    \4\ The National Forensic Laboratory Information System (NFLIS) 
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. NFLIS data was queried on March 26, 2019.
---------------------------------------------------------------------------

Role of Norfentanyl in the Synthesis of Fentanyl

    Fentanyl is not a naturally occurring substance. As such, the 
manufacture of fentanyl requires it to be produced through synthetic 
organic chemistry. Synthetic organic chemistry is the process for 
creating a new organic molecule through a series of chemical reactions, 
which involve precursor chemicals. In the early 2000's, a synthetic 
process, commonly known as the Siegfried method, was utilized to 
manufacture fentanyl in several domestic and foreign clandestine 
laboratories. 72 FR 20039. At that time, DEA had determined that two 
primary synthesis routes (i.e., the Janssen method and the Siegfried 
method) were being used to produce fentanyl clandestinely, although it 
believed the Janssen synthesis route to be difficult to perform and 
beyond the rudimentary skills of most clandestine laboratory operators. 
The Siegfried synthetic route involves two important intermediates, N-
phenethyl-4-piperidone (NPP) and 4-anilino-N-phenethylpiperidine 
(ANPP).

[[Page 21321]]

The DEA controlled NPP on April 23, 2007 as a list I chemical by 
interim rule (72 FR 20039), which was finalized on July 25, 2008. 73 FR 
43355. By final rule published on June 29, 2010, ANPP was controlled as 
a schedule II immediate precursor to fentanyl, with an effective date 
of August 30, 2010. 75 FR 37295.
    In 2017, the United Nations Commission on Narcotic Drugs 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 increase of fentanyl on the illicit drug 
market. 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.
    Recent law enforcement information indicates that illicit 
manufacturers of fentanyl also use other synthetic routes in response 
to regulations placed on NPP and ANPP. One of these other routes is the 
original published synthetic pathway to fentanyl, known as the Janssen 
method, previously thought to be beyond the skills of most clandestine 
laboratory operators. This synthetic route does not involve NPP or ANPP 
as precursors. This synthetic pathway involves the important precursors 
N-(1-benzylpiperidin-4-yl)-N-phenylpropionamide (benzylfentanyl) and N-
phenyl-N-(piperidin-4-yl)propionamide (norfentanyl). Benzylfentanyl is 
converted into norfentanyl in one chemical reaction. Norfentanyl is 
then subjected to one simple chemical reaction to complete the 
synthesis of fentanyl. The DEA is not aware of any legitimate uses of 
benzylfentanyl or norfentanyl other than in the synthesis of fentanyl.
    According to DEA forensic laboratory data, the Janssen method was 
confirmed as the synthetic route used in 94 percent of 85 fentanyl drug 
exhibits that were evaluated to determine the synthetic route. These 
exhibits were seized in 2018. In addition, the number of law 
enforcement encounters of benzylfentanyl increased in 2017 and 2018. As 
stated above, benzylfentanyl is a precursor chemical used to synthesize 
norfentanyl in the Janssen method. According to NFLIS,\5\ there was one 
identification of benzylfentanyl in 2016; however, benzylfentanyl was 
identified in 195 reports in 2017 and 237 reports in 2018. This is 
believed to indicate a change in the synthetic route used by some 
clandestine chemists to manufacture fentanyl in efforts to evade 
chemical regulations on NPP and ANPP. The increase in law enforcement 
encounters coincides with the international control that placed NPP and 
ANPP in Table I of the 1988 Convention in 2017.
---------------------------------------------------------------------------

    \5\ NFLIS data was queried on March 26, 2019.
---------------------------------------------------------------------------

    The DEA determined that norfentanyl is commercially available from 
both domestic and foreign chemical suppliers. The DEA has identified 30 
domestic suppliers and 22 foreign suppliers of norfentanyl from Canada 
(3), China (7), Germany (2), Hong Kong (1), India (1), Japan (2), 
Switzerland (1), and the United Kingdom (5). Of the 30 domestic 
suppliers of norfentanyl, only one is a DEA registrant. As it appears 
that these other 29 suppliers are not registered to manufacture 
schedule II controlled substances, it is not likely these suppliers are 
manufacturing fentanyl. Norfentanyl is attractive to illicit 
manufacturers because of the lack of chemical regulations on this 
substance, it is readily available from chemical suppliers, and it can 
easily be converted to the schedule II controlled substance fentanyl, 
in a one-step chemical reaction.

Designation as an Immediate Precursor

    Under 21 U.S.C. 811(e), the Attorney General may place an immediate 
precursor into the same schedule as the controlled substance that the 
immediate precursor is used to make. The substance must meet the 
requirements of an immediate precursor under 21 U.S.C. 802(23). The 
term ``immediate precursor'' is defined in 21 U.S.C. 802(23) meaning a 
substance being the principal compound used, or which is produced 
primarily for use in the manufacture of a controlled substance; which 
is an immediate chemical intermediary used or likely to be used in the 
manufacture of the controlled substance; and the control of which is 
necessary to prevent or limit the manufacture of such controlled 
substance.
    The DEA finds that norfentanyl meets the three criteria for the 
definition of an immediate precursor under 21 U.S.C. 802(23). First, 
DEA finds that norfentanyl is produced primarily for use in the 
manufacture of the schedule II controlled substance fentanyl. As stated 
in the preceding section, under the Janssen method, norfentanyl is 
typically produced from the starting material benzylfentanyl and is 
then subjected to a simple one-step chemical reaction to obtain the 
schedule II controlled substance, fentanyl. The DEA is not aware of any 
legitimate use of benzylfentanyl other than in the synthesis of 
norfentanyl, and subsequently, fentanyl. The DEA has also not 
identified an industrial or other use for norfentanyl beyond the 
manufacture of fentanyl. DEA has not identified any other legitimate 
uses of norfentanyl and DEA did not receive comment to the contrary 
during the notice and comment period of the NPRM published on September 
17, 2019. 84 FR 48815.
    Second, DEA finds that norfentanyl is an immediate chemical 
intermediary used in the manufacture of the controlled substance 
fentanyl. As stated earlier, norfentanyl is produced as an intermediary 
in the fentanyl synthetic pathway. After it is synthesized, norfentanyl 
is subjected to a simple chemical reaction that converts it directly to 
fentanyl.
    Third, DEA finds that controlling norfentanyl is necessary to 
prevent, curtail, and limit the unlawful manufacture of the controlled 
substance, fentanyl. The DEA believes this action is necessary to 
assist in preventing the possible theft of norfentanyl from legitimate 
firms. The DEA believes that clandestine manufacturers will attempt to 
procure unregulated chemicals in their efforts to synthesize fentanyl. 
As a schedule II substance, norfentanyl will be safeguarded to the same 
degree that pharmaceutical firms now safeguard the fentanyl that they 
produce. Since norfentanyl is an immediate chemical intermediary in the 
manufacture of fentanyl, the increased level of security is necessary 
to prevent diversion of norfentanyl from legitimate firms. DEA also 
believes control is necessary to prevent unscrupulous chemists from 
synthesizing norfentanyl and selling it (as an unregulated material) 
through the internet and other channels to individuals who may wish to 
acquire an unregulated precursor for the purpose of manufacturing 
fentanyl, a schedule II controlled substance.
    The DEA believes that the control of norfentanyl is necessary to 
prevent its production and use in the illicit manufacture of fentanyl. 
Therefore, DEA is designating norfentanyl as an immediate precursor of 
fentanyl, a schedule II controlled substance, pursuant to 21 U.S.C. 
802(23) and 21 U.S.C. 811(e).

Placement in Schedule II--Findings Required Under CSA Immediate 
Precursor Provisions

    Pursuant to 21 U.S.C. 811(e), once norfentanyl is designated as an 
immediate precursor under 21 U.S.C. 802(23), it may be placed directly 
into schedule II (or a schedule with a higher numerical designation). 
The immediate precursor provision in 21 U.S.C. 811(e)

[[Page 21322]]

permits DEA to schedule an immediate precursor ``without regard to the 
findings required by'' section 811(a) or section 812(b) and ``without 
regard to the procedures'' prescribed by section 811(a) and (b). 
Accordingly, DEA need not address the ``factors determinative of 
control'' in section 811 or the findings required for placement in 
schedule II in section 812(b)(2). Based on the finding that norfentanyl 
is an ``immediate precursor'' for fentanyl, DEA is hereby placing 
norfentanyl directly into schedule II.

NPRM Comments

    As part of the proposed rulemaking published on September 17, 2019 
(84 FR 48815), DEA specifically solicited input from all potentially 
affected parties regarding: (1) The types of legitimate industries 
using norfentanyl; (2) the legitimate uses of norfentanyl; (3) the size 
of the domestic market for norfentanyl; (4) the number of manufacturers 
of norfentanyl; (5) the number of distributors of norfentanyl; (6) the 
level of import and export of norfentanyl; (7) the potential burden 
these proposed regulatory controls of norfentanyl may have on 
legitimate commercial activities; (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 norfentanyl by industry and others.
    As part of the proposed rulemaking published on September 17, 2019 
(84 FR 48815), DEA solicited information on any possible legitimate 
uses of norfentanyl unrelated to fentanyl production (including 
industrial uses) in order to assess the potential commercial impact of 
scheduling norfentanyl. The DEA searched information in the public 
domain for legitimate uses of norfentanyl and could not document 
legitimate commercial uses for norfentanyl other than as an 
intermediary chemical in the manufacture of fentanyl. DEA sought, 
however, to document any unpublicized use(s) and other proprietary 
use(s) of norfentanyl not in the public domain. Therefore, DEA 
solicited comment on the uses of norfentanyl in the legitimate 
marketplace. The DEA also solicited comment on the regulatory burden to 
legitimate commercial activities that would result from the placement 
of norfentanyl in schedule II of the CSA. The DEA did not receive 
comment on these topics.
    The DEA invited all interested parties to provide any information 
on any legitimate uses of norfentanyl in industry, commerce, academia, 
research and development, or other applications. The DEA sought both 
quantitative and qualitative data; however, DEA did not receive 
comments on these topics.
    The DEA received 15 comments in response to the NPRM. Thirteen of 
the 15 commenters were in support of controlling norfentanyl as a 
schedule II immediate precursor. The other two commenters did not 
specifically object to this rule. One of those two commenters stated 
that substance abuse is a public health issue and not a law enforcement 
issue. The other stated that this rule is not sufficient to disrupt the 
fentanyl market in the United States because illicit fentanyl is not 
produced in the United States. The commenter proposed access 
restriction and harm reduction strategies, including increased public 
awareness of drugs mixed with fentanyl and increased law enforcement at 
entry locations, as additional recommendations to reduce fentanyl 
misuse and abuse in the United States.
    Of the 13 commenters in support of controlling norfentanyl as a 
schedule II immediate precursor, four commenters also included 
statements that the control of norfentanyl is not the only solution to 
address the opioid epidemic. These commenters stated that control of 
norfentanyl will not solve the issue of fentanyl being shipped into our 
country from foreign producers; that control of norfentanyl is not the 
only policy that should be addressed and implemented, and that 
alternate pathways to fentanyl should be monitored; and that control of 
norfentanyl will not end the opioid epidemic.
    DEA response: The DEA appreciates the comments in support of 
controlling norfentanyl as a schedule II immediate precursor. The DEA 
is concerned with the abuse of illicitly manufactured fentanyl in the 
United States and abroad. While DEA remains aware that a comprehensive 
approach, to include community outreach and education, is required to 
combat the opioid epidemic, DEA believes that supply reduction 
strategies, which this rule attempts to address, are important aspects 
to reduce drug abuse in the United States. The control of norfentanyl 
as a schedule II immediate precursor is one aspect of the overall 
effort to combat the opioid epidemic. The DEA believes this rule will 
have a significant effect on reducing the supply of illicitly 
manufactured fentanyl.
    With respect to the comments about illicit fentanyl being 
manufactured outside of the United States and shipped into the country 
from foreign producers, the designation of norfentanyl as a schedule II 
immediate precursor will subject this substance to the regulatory 
requirements of schedule II substances, including the import and export 
regulations. 21 CFR part 1312. The DEA believes that regulating the 
import and export of norfentanyl will reduce the quantity of 
norfentanyl destined to illicit fentanyl manufacturers, both 
domestically and internationally, by removing the United States as a 
transshipment point and as a source of diverted norfentanyl to foreign 
illicit fentanyl manufacturers.
    The DEA is the leading agency on enforcement of drug control laws 
and remains committed to protecting the public by interrupting and 
reducing drug supply and availability in the United States. The DEA 
believes that the control of norfentanyl as an immediate precursor of 
the schedule II controlled substance fentanyl will have a significant 
impact on reducing the supply of illicitly manufactured fentanyl; 
however, DEA remains aware that supply reduction is not the only aspect 
of combatting the opioid epidemic. The DEA realizes that a 
comprehensive approach, to include community outreach and education, is 
required to combat the opioid epidemic. In response to the comment 
regarding access restriction and harm reduction strategies and the 
comment stating that substance abuse is a public health issue and not a 
law enforcement issue, DEA intends this scheduling action to reduce the 
supply of illicitly manufactured fentanyl, which is part of a multi-
faceted strategy to combat the opioid epidemic. DEA continues to work 
with other federal agencies on holistic and comprehensive approaches to 
reduce drug abuse; however, such approaches are beyond the scope of 
this rule.

Requirements for Handling Norfentanyl

    This rulemaking finalizes two actions. It (1) designates 
norfentanyl as an immediate precursor for the schedule II controlled 
substance, fentanyl, under the definition set forth in 21 U.S.C. 
802(23); and (2) controls norfentanyl as a schedule II substance 
pursuant to the authority in 21 U.S.C. 811(e).
    The scheduling of norfentanyl as an immediate precursor of the 
schedule II controlled substance, fentanyl, subjects norfentanyl to all 
of the regulatory controls and administrative, civil, and criminal 
sanctions applicable to the manufacture, distribution, dispensing, 
importing, and exporting of a schedule II controlled substance. The 
regulatory requirements will include the following:

[[Page 21323]]

    1. Registration. Any person who manufactures, distributes, 
dispenses, imports, or exports norfentanyl, engages in research with 
respect to norfentanyl, or proposes to engage in such activities will 
be required to submit an application and be accepted for schedule II 
registration in accordance with 21 CFR part 1301.
    2. Security. Norfentanyl will be subject to schedule II security 
requirements. In order to prevent diversion, norfentanyl will be 
manufactured, distributed, and stored in accordance with the standards 
for physical security and the operating procedures set forth in 21 CFR 
1301.71, 1301.72(a), (c), and (d), 1301.73, 1301.74, 1301.75(b),(c), 
and (d) 1301.76, and 1301.77.
    3. Labeling and Packaging. All labels and labeling for commercial 
containers of norfentanyl that are distributed will be required to 
comply with the requirements of 21 CFR 1302.03-1302.07.
    4. Quotas. Quotas for norfentanyl will be established pursuant to 
21 CFR part 1303.
    5. Inventory. Every registrant who possesses any quantity of 
norfentanyl will be required to keep an inventory of all stocks of the 
substance on hand pursuant to 21 CFR 1304.03, 1304.04 and 1304.11.
    6. Records and Reports. Every DEA registrant will be required to 
maintain records and submit reports with respect to norfentanyl 
pursuant to 21 U.S.C. 827 and in accordance with 21 CFR parts 1304 and 
1312.
    7. Order Forms. Every DEA registrant who distributes norfentanyl 
will be required to comply with the order form requirements pursuant to 
21 U.S.C. 828 and in accordance with 21 CFR part 1305.
    8. Importation and Exportation. All importation and exportation of 
norfentanyl will be required to be in compliance with 21 U.S.C. 952, 
953, 957, and 958, and in accordance with 21 CFR part 1312.
    9. 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 controlled substance 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. 21 U.S.C. 880.
    10. Liability. Any activity with norfentanyl in violation of or not 
authorized under the Controlled Substances Act or the Controlled 
Substances Import and Export Act will be unlawful and potentially 
subject to criminal penalties. 21 U.S.C. 841-863 and 959-964.

Regulatory Analyses

Executive Orders 12866, 13563, and 13771, Regulatory Planning and 
Review, Improving Regulation and Regulatory Review, and Reducing 
Regulation and Controlling Regulatory Costs

    This rulemaking was developed in accordance with the principles of 
Executive Orders 12866, 13563, and 13771. Executive Order 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). Executive Order 13563 is supplemental to and reaffirms the 
principles, structures, and definitions governing regulatory review as 
established in Executive Order 12866. Executive Order 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 Executive Order. DEA has determined that this rule is not a 
``significant regulatory action'' under Executive Order 12866, section 
3(f). Executive Order 13771 requires an agency, unless prohibited by 
law, to identify at least two existing regulations to be repealed when 
the agency publicly proposes for notice and comment or otherwise 
promulgates a new regulation.\6\ In furtherance of this requirement, 
Executive Order 13771 requires that the new incremental costs 
associated with new regulations, to the extent permitted by law, be 
offset by the elimination of existing costs associated with at least 
two prior regulations.\7\ According to guidance provided by OMB, the 
requirements of Executive Order 13771 only apply to each new 
``significant regulatory action that . . . imposes costs.'' \8\ This 
rule is not expected to be an Executive Order 13771 regulatory action 
because this rule is not significant under Executive Order 12866.
---------------------------------------------------------------------------

    \6\ Sec. 2(a).
    \7\ Sec. 2(c).
    \8\ OMB Guidance Implementing Executive Order 13771 titled 
``Reducing Regulation and Controlling Regulatory Costs'' (April 5, 
2017).
---------------------------------------------------------------------------

    The scheduling of norfentanyl as an immediate precursor of the 
schedule II controlled substance, fentanyl, subjects norfentanyl to all 
of the regulatory controls and administrative, civil, and criminal 
sanctions applicable to the manufacture, distribution, dispensing, 
importing, and exporting of a schedule II controlled substance. 
Norfentanyl is the immediate chemical intermediary in a synthesis 
process currently used by clandestine laboratory operators for the 
manufacture of the schedule II controlled substance fentanyl. The 
distribution of illicitly manufactured fentanyl has caused an 
unprecedented outbreak of thousands of fentanyl-related overdoses in 
the United States in recent years.
    The DEA has not identified any industrial use for norfentanyl, 
other than its role as an intermediary chemical in the manufacture of 
fentanyl. Based on the review of import and quota information for ANPP 
and fentanyl, DEA believes the vast majority, if not all, of legitimate 
pharmaceutical fentanyl is produced from ANPP (schedule II immediate 
precursor for fentanyl), not norfentanyl. The quantities of ANPP 
permitted in the U.S., imported or manufactured pursuant to a quota, 
generally correspond with the quantities of legitimate pharmaceutical 
fentanyl produced in the United States. Additionally, DEA is not aware 
of norfentanyl being used for the manufacturing of legitimate 
pharmaceutical fentanyl; however, DEA cannot rule out the possibility 
that minimal quantities of norfentanyl are used for this purpose. If 
there are any quantities of norfentanyl used for the manufacturing of 
legitimate pharmaceutical fentanyl, the quantities are believed to be 
small and economically insignificant.
    The DEA evaluated the costs and benefits of this action.

[[Page 21324]]

Costs

    The DEA believes the market for norfentanyl for the legitimate 
manufacturing of pharmaceutical fentanyl is minimal. As stated above, 
the only use for norfentanyl of which DEA is aware is for the 
manufacturing of fentanyl. Any manufacturer, distributor, importer, or 
exporter of norfentanyl for the production of legitimate pharmaceutical 
fentanyl, if they exist at all, would incur costs. The primary costs 
associated with this rule include costs associated with complying with 
registration, physical security, labeling and packaging, quota, 
inventory, recordkeeping and reporting, and importation and exportation 
requirements. Other than the annual registration fees ($3,047 for 
manufacturers and $1,523 for distributors, importers, and exporters), 
due to the many unknowns and variability between entities, it is highly 
difficult to quantify the potential total cost burden of this 
regulation. However, any manufacturer that uses norfentanyl for 
legitimate pharmaceutical fentanyl production would already be 
registered with DEA and have all security and other handling processes 
in place, resulting in minimal cost. Any lost sales or profit 
attributed to those manufacturers or suppliers that are not for 
legitimate pharmaceutical fentanyl are excluded from the analysis as 
they are, whether passively or actively, facilitating the manufacture 
of illicit fentanyl.
    The DEA has identified 30 domestic suppliers of norfentanyl, 29 of 
which are not registered with DEA to handle schedule II controlled 
substances. It is difficult to estimate how much norfentanyl is 
distributed by these suppliers. It is common for chemical distributors 
to have items on their catalog while not actually having any material 
level of sales. Based on the review of import and quota information for 
fentanyl and ANPP, where the quantities of ANPP imported and 
manufactured generally correspond with the quantities of fentanyl 
produced, DEA believes any quantity of sales from these distributors 
for the legitimate pharmaceutical fentanyl manufacturing is minimal. 
Suppliers for the legitimate use of norfentanyl are expected to choose 
the least-cost option, and stop selling the minimal quantities, if any, 
of norfentanyl, rather than incur the costs of complying with the 
regulatory requirements. Because DEA believes the quantities of 
norfentanyl supplied for the legitimate manufacturing of pharmaceutical 
fentanyl is minimal, DEA estimates that the cost of foregone sales is 
minimal; and thus, the cost of this rule is minimal.
    This analysis excludes consideration of economic impact to those 
businesses that facilitate the manufacturing and distribution of 
norfentanyl for the manufacture of illicit fentanyl. The only use for 
norfentanyl of which DEA is currently aware is the manufacture of 
fentanyl. Although these suppliers are selling a currently unregulated 
substance, they wittingly or unwittingly facilitate the manufacturing 
of illicit fentanyl. 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 norfentanyl is expected to prevent, curtail, and limit 
the unlawful manufacture and distribution of the controlled substance, 
fentanyl. This action is also expected to assist preventing the 
possible theft or diversion of norfentanyl from any legitimate firms. 
As a schedule II substance, norfentanyl will be safeguarded to the same 
degree that pharmaceutical firms now safeguard the fentanyl that they 
produce. The DEA also believes control is necessary to prevent 
unscrupulous chemists from synthesizing norfentanyl and selling it (as 
an unregulated material) through the internet and other channels, to 
individuals who may wish to acquire an unregulated precursor for the 
purpose of manufacturing illicit fentanyl.
    In summary, DEA conducted a qualitative analysis of costs and 
benefits. DEA believes this action will minimize the diversion of 
norfentanyl. The DEA believes the market for norfentanyl for the 
legitimate manufacturing of pharmaceutical fentanyl is minimal. 
Therefore, any potential cost as a result of this regulation is 
minimal. Therefore, the estimated economic impact of this rule is less 
than $100 million in any given year.

Executive Order 12988, Civil Justice Reform

    This regulation meets the applicable standards set forth in 
sections 3(a) and 3(b)(2) of Executive Order 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 rulemaking does not have federalism implications warranting 
the application of Executive Order 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 Executive Order 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 Acting Administrator, in accordance with the Regulatory 
Flexibility Act (5 U.S.C. 601-612) (RFA), 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, 
the scheduling of norfentanyl as an immediate precursor of the schedule 
II controlled substance, fentanyl, subjects norfentanyl to all of the 
regulatory controls and administrative, civil, and criminal sanctions 
applicable to the manufacture, distribution, dispensing, importing, and 
exporting of a schedule II controlled substance. Norfentanyl is the 
immediate chemical intermediary in a synthesis process currently used 
by clandestine laboratory operators for the illicit manufacture of the 
schedule II controlled substance fentanyl. The distribution of 
illicitly manufactured fentanyl has caused an unprecedented outbreak of 
thousands of fentanyl-related overdoses in the United States in recent 
years.
    The DEA has not identified any use for norfentanyl, other than its 
role as an intermediary chemical in the manufacture of fentanyl. Based 
on the review of import and quota information for ANPP and fentanyl, 
DEA believes the vast majority, if not all, of legitimate 
pharmaceutical fentanyl is produced from ANPP (schedule II immediate 
precursor for fentanyl), not norfentanyl. The quantities of ANPP 
permitted in the U.S., imported or manufactured pursuant to a quota, 
generally correspond with the quantities of

[[Page 21325]]

legitimate pharmaceutical fentanyl produced in the United States. 
Additionally, DEA is not aware of norfentanyl being used for the 
manufacturing of legitimate pharmaceutical fentanyl; however, DEA 
cannot rule out the possibility that minimal quantities of norfentanyl 
are used for this purpose. If there are any quantities of norfentanyl 
used for the manufacturing of legitimate pharmaceutical fentanyl, the 
quantities are believed to be small and economically insignificant.
    The DEA has identified 30 domestic suppliers of norfentanyl. Based 
on the Small Business Administration size standard for chemical 
distributors and Statistics of United States Business data, 94.5 
percent or 28.4 (rounded to 28) are estimated to be small entities. It 
is difficult to know how much norfentanyl is distributed by these 
suppliers. It is common for chemical distributors to have items on 
their catalog while not actually having any material level of sales. 
Based on the review of import and quota information for fentanyl and 
ANPP, where the quantities of ANPP imported and manufactured generally 
correspond with the quantities of fentanyl produced, DEA believes any 
quantity of sales from these distributors for the legitimate 
pharmaceutical fentanyl manufacturing is minimal. Therefore, DEA 
estimates the cost of this rule on any affected small entity is 
minimal.
    Because of these facts, this rule will not result in a significant 
economic impact on a substantial number of small entities.

Unfunded Mandates Reform Act of 1995

    On the basis of information contained in the ``Regulatory 
Flexibility Act'' section above, DEA determined and certifies pursuant 
to the Unfunded Mandates Reform Act of 1995 (UMRA), 2 U.S.C. 1501 et 
seq., that this action will not result in any Federal mandate that may 
result ``in the expenditure by State, local, and tribal governments, in 
the aggregate, or by the private sector, of $100,000,000 or more 
(adjusted for inflation) in any one year * * *.'' Therefore, neither a 
Small Government Agency Plan nor any other action is required under 
provisions of UMRA.

Paperwork Reduction Act

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

List of Subjects in 21 CFR Part 1308

    Administrative practice and procedure, drug traffic control, 
reporting and recordkeeping requirements.

    For the reasons set out above, DEA amends 21 CFR part 1308 as 
follows:

PART 1308--SCHEDULES OF CONTROLLED SUBSTANCES

0
1. The authority citation for 21 CFR part 1308 continues to read as 
follows:

    Authority: 21 U.S.C. 811, 812, 871(b), 956(b), unless otherwise 
noted.


0
2. Amend Sec.  1308.12 by adding paragraph (g)(3)(ii) to read as 
follows.


Sec.  1308.12   Schedule II.

* * * * *
    (g) * * *
    (3) * * *

(ii) N-phenyl-N-(piperidin-4-yl)propionamide    8366
 (norfentanyl).
 

* * * * *

    Dated: March 5, 2020.
Uttam Dhillon,
Acting Administrator.
[FR Doc. 2020-07381 Filed 4-16-20; 8:45 am]
BILLING CODE 4410-09-P