Control of the Immediate Precursor Norfentanyl Used in the Illicit Manufacture of Fentanyl as a Schedule II Controlled Substance, 48815-48820 [2019-19786]

Agencies

• Drug Enforcement Administration
• Department of Justice

[Federal Register Volume 84, Number 180 (Tuesday, September 17, 2019)]
[Proposed Rules]
[Pages 48815-48820]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2019-19786]


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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: Notice of proposed rulemaking.

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

DATES: Comments must be submitted electronically or postmarked on or 
before November 18, 2019. Commenters should be aware that the 
electronic Federal Docket Management System will not accept any 
comments after 11:59 p.m. Eastern Time on the last day of the comment 
period.

ADDRESSES: To ensure proper handling of comments, please reference 
``Docket No. DEA-496'' on all electronic and written correspondence, 
including any attachments.
     Electronic comments: The DEA encourages that all comments 
be submitted electronically through the Federal eRulemaking Portal 
which provides the ability to type short comments directly into the 
comment field on the web page or attach a file for lengthier comments. 
Please go to https://www.regulations.gov and follow the online 
instructions at that site for submitting comments. Upon completion of 
your submission, you will receive a Comment Tracking Number for your 
comment. Please be aware that submitted comments are not 
instantaneously available for public view on Regulations.gov. If you 
have received a Comment Tracking Number, your comment has been 
successfully submitted and there is no need to resubmit the same 
comment.
     Paper comments: Paper comments that duplicate the 
electronic submissions are not necessary. Should you wish to mail a 
paper comment, in lieu of an electronic comment, it should be sent via 
regular or express mail to: Drug Enforcement Administration, Attn: DEA 
Federal Register Representative/DPW, 8701 Morrissette Drive, 
Springfield, Virginia 22152.

FOR FURTHER INFORMATION CONTACT: 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: (202) 598-6812.

SUPPLEMENTARY INFORMATION:

Posting of Public Comments

    Please note that all comments received in response to this docket 
are considered part of the public record. They will, unless reasonable 
cause is given, be made available by the DEA for public inspection 
online at https://www.regulations.gov. Such information includes 
personal identifying information (such as your name, address, etc.) 
voluntarily submitted by the commenter. The Freedom of Information Act 
(FOIA) applies to all comments received. If you want to submit personal 
identifying information (such as your name, address, etc.) as part of 
your comment, but do not want it to be made publicly available, you 
must include the phrase ``PERSONAL

[[Page 48816]]

IDENTIFYING INFORMATION'' in the first paragraph of your comment. You 
must also place all of the personal identifying information you do not 
want made publicly available in the first paragraph of your comment and 
identify what information you want redacted.
    If you want to submit confidential business information as part of 
your comment, but do not want it to be made publicly available, you 
must include the phrase ``CONFIDENTIAL BUSINESS INFORMATION'' in the 
first paragraph of your comment. You must also prominently identify the 
confidential business information to be redacted within the comment.
    Comments containing personal identifying information or 
confidential business information identified as directed above will be 
made publicly available in redacted form. If a comment has so much 
confidential business information that it cannot be effectively 
redacted, all or part of that comment may not be made publicly 
available. Comments posted to https://www.regulations.gov may include 
any personal identifying information (such as name, address, and phone 
number) included in the text of your electronic submission that is not 
identified as directed above as confidential.
    An electronic copy of this proposed rule is available at https://www.regulations.gov for easy reference.

Legal Authority

    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. 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%) 
involved fentanyl.\2\ Of the 63,632 drug overdose deaths in 2016, 
18,335 (28.8%) involved fentanyl. This was the first time that fentanyl 
was reported in more drug related fatalities than heroin.
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    \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.
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    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%) 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% 
from 19,413 deaths in 2016 to 28,466 deaths in 2017.
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    \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.
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    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.
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    \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.
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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, the 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). 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. ANPP was controlled as a schedule II 
immediate precursor to fentanyl on August 30, 2010. 75 FR 37295. (June 
29, 2010).
    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, 
which is subject to a Notice of Proposed Rulemaking for control as a 
list I chemical published elsewhere in this issue of the Federal 
Register, is converted into norfentanyl in one chemical reaction. 
Norfentanyl is

[[Page 48817]]

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% 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.
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    \5\ NFLIS data was queried on March 26, 2019.
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    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'' as defined in 21 U.S.C. 802(23) means a 
substance:
    (A) which the Attorney General has found to be and by regulation 
designated as being the principal compound used, or produced primarily 
for use, in the manufacture of a controlled substance;
    (B) which is an immediate chemical intermediary used or likely to 
be used in the manufacture of such controlled substance; and
    (C) the control of which is necessary to prevent, curtail, 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, 
the 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. Although DEA has not identified any other 
legitimate uses of norfentanyl, this notice of proposed rulemaking 
provides the public an opportunity to provide information to the 
contrary, as described in the ``Solicitation for Information'' section 
below.
    Second, the 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, the 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 effort 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. 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 
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 production of fentanyl. 
Therefore, the DEA is proposing the designation of 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).

Proposed 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) permits the 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, the 
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, the DEA proposes to place 
norfentanyl directly into schedule II.

Requirements for Handling Norfentanyl

    The proposed scheduling of norfentanyl as an immediate precursor of 
the schedule II controlled substance, fentanyl, would subject 
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. If norfentanyl is placed in schedule II, the 
regulatory requirements will include the following:
    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 would 
be required to submit an application and be accepted for

[[Page 48818]]

schedule II registration in accordance with 21 CFR part 1301.
    2. Security. Norfentanyl would be subject to schedule II security 
requirements. In order to prevent diversion, norfentanyl would have to 
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) and (c), 1301.76, and 1301.77.
    3. Labeling and Packaging. All labels and labeling for commercial 
containers of norfentanyl that are distributed would be required to 
comply with the requirements of 21 CFR 1302.03-1302.07.
    4. Quotas. Quotas for norfentanyl would be established pursuant to 
21 CFR part 1303.
    5. Inventory. Every registrant who possesses any quantity of 
norfentanyl would 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 would 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 
would 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 would 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. Liability. Any activity with norfentanyl in violation of or not 
authorized under the Controlled Substances Act or the Controlled 
Substances Import and Export Act would be unlawful and potentially 
subject to criminal penalties (21 U.S.C. 841-863 and 959-964).

Solicitation for Information

    As part of this proposed rulemaking, the DEA is soliciting 
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 has 
searched information in the public domain for legitimate uses of 
norfentanyl and has not documented legitimate commercial uses for 
norfentanyl other than as an intermediary chemical in the production of 
fentanyl. The DEA seeks, however, to document any unpublicized use(s) 
and other proprietary use(s) of norfentanyl not in the public domain. 
Therefore, the DEA is soliciting comment on the uses of norfentanyl in 
the legitimate marketplace. DEA is also soliciting comment on the 
regulatory burden to legitimate commercial activities that would result 
from the proposed placement of norfentanyl in schedule II of the CSA.
    The DEA is soliciting 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. The 
DEA invites 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 seeks both 
quantitative and qualitative data.

Handling of Confidential or Proprietary Information

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

Regulatory Analyses

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

    This proposed rule 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. The DEA has determined that this proposed 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 
proposed rule is not expected to be an E.O. 13771 regulatory action 
because this proposed rule is not significant under E.O. 12866.
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    \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).
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    The scheduling of norfentanyl as an immediate precursor of the 
schedule II controlled substance, fentanyl, would subject norfentanyl 
to all of the regulatory controls and administrative, civil, and 
criminal sanctions applicable to the manufacture, distribution,

[[Page 48819]]

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 production of fentanyl. Based 
on the review of import and quota information for ANPP and fentanyl, 
the 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 U.S. Additionally, the DEA is not aware of 
norfentanyl being used for the manufacturing of legitimate 
pharmaceutical fentanyl; however, the 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 proposed action.
Costs
    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 the 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 if this proposed rule 
were finalized. The primary costs associated with this proposed 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 proposed regulation. However, any 
manufacturer that uses norfentanyl for legitimate pharmaceutical 
fentanyl production would already be registered with the 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 the 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, the DEA believes any quantity of sales from these 
distributors for the legitimate pharmaceutical fentanyl manufacturing 
is minimal. If this proposed rule is finalized, 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 the DEA believes the quantities of 
norfentanyl supplied for the legitimate manufacturing of pharmaceutical 
fentanyl is minimal, the DEA estimates that the cost of foregone sales 
is minimal; and thus, the cost of this proposed rule is minimal. The 
DEA welcomes any public comment regarding this estimate.
    This analysis excludes consideration of economic impact to those 
businesses that facilitate the manufacturing and distribution of 
norfentanyl for the production of manufacturing illicit fentanyl. The 
only use for norfentanyl of which the DEA is currently aware is the 
production 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, the 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 would 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, the DEA conducted a qualitative analysis of costs and 
benefits. The DEA believes this action, if finalized, 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 proposed rule 
is less than $100 million in any given year.

Executive Order 12988, Civil Justice Reform

    This proposed 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 proposed rulemaking does not have federalism implications 
warranting the application of Executive Order 13132. The proposed rule 
does not have substantial direct effects on the States, on the 
relationship between the national government and the States, or the 
distribution of power and responsibilities among the various levels of 
government.

Executive Order 13175, Consultation and Coordination With Indian Tribal 
Governments

    This proposed rule does not have tribal implications warranting the 
application of Executive Order 13175. This proposed rule does not have 
substantial direct effects on one or more Indian tribes, on the 
relationship between the Federal Government and

[[Page 48820]]

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 proposed 
rule and by approving it certifies that it will not have a significant 
economic impact on a substantial number of small entities. As discussed 
above, the proposed scheduling of norfentanyl as an immediate precursor 
of the schedule II controlled substance, fentanyl, would subject 
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 production of fentanyl. Based 
on the review of import and quota information for ANPP and fentanyl, 
the 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 U.S. Additionally, the DEA is not aware of 
norfentanyl being used for the manufacturing of legitimate 
pharmaceutical fentanyl; however, the 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 Small Business Administration size standard for chemical 
distributors and Statistics of U.S. Business data, 94.5% 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, the DEA believes any quantity of 
sales from these distributors for the legitimate pharmaceutical 
fentanyl manufacturing is minimal. Therefore, the DEA estimates the 
cost of this rule on any affected small entity is minimal. The DEA 
welcomes any public comment regarding this estimate.
    Because of these facts, this proposed rule will not, if 
promulgated, 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, the DEA 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.

Paperwork Reduction Act

    This proposed action does not impose a new collection of 
information under the Paperwork Reduction Act, 44 U.S.C. 3501-3521. 
This proposed action would 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, the DEA proposes to amend 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 a new paragraph (g)(3)(ii) and adding 
and reserving paragraph (g)(3)(iii) to read as follows.


Sec.  1308.12  Schedule II.

* * * * *
    (g) * * *
    (3) * * *
    (ii) N-phenyl-N-(piperidin-4-yl)propionamide (norfentanyl)--8366
    (iii) [Reserved]
* * * * *

    Dated: September 6, 2019.
Uttam Dhillon,
Acting Administrator.
[FR Doc. 2019-19786 Filed 9-16-19; 8:45 am]
 BILLING CODE 4410-09-P