Control of Immediate Precursor Used in the Illicit Manufacture of Fentanyl as a Schedule II Controlled Substance, 37295-37299 [2010-15520]

Agencies

• Drug Enforcement Administration
• Department of Justice

[Federal Register Volume 75, Number 124 (Tuesday, June 29, 2010)]
[Rules and Regulations]
[Pages 37295-37299]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: 2010-15520]


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DEPARTMENT OF JUSTICE

Drug Enforcement Administration

21 CFR Part 1308

[Docket No. DEA-305F]
RIN 1117-AB16


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

AGENCY: Drug Enforcement Administration (DEA), Department of Justice.

ACTION: Final Rule.

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SUMMARY: The Drug Enforcement Administration (DEA) is designating the 
precursor chemical, 4-anilino-N-phenethyl-4-piperidine (ANPP) as an 
immediate precursor for the schedule II controlled substance fentanyl 
under the definition set forth in 21 U.S.C. 802(23). Furthermore, DEA 
is finalizing the control of ANPP as a schedule II substance under the 
Controlled Substances Act (CSA), pursuant to the authority in 21 U.S.C. 
811(e), which states that an immediate precursor may be placed in the 
same schedule as the controlled substance it produces, without regard 
to the procedures required by 21 U.S.C. 811(a) and (b) and without 
regard to the findings required by 21 U.S.C. 811(a) and 812(b).
    ANPP is the immediate chemical intermediary in the synthesis 
process currently used by clandestine laboratory operators for the 
illicit manufacture of the schedule II controlled substance fentanyl. 
In 2005 and 2006, the distribution of illicitly manufactured fentanyl 
caused an unprecedented outbreak of hundreds of fentanyl-related

[[Page 37296]]

overdoses in the United States. DEA believes that the control of ANPP 
as a schedule II controlled substance is necessary to prevent its 
diversion as an immediate chemical intermediary for the illicit 
production of fentanyl.

DATES: This rulemaking becomes effective August 30, 2010.

FOR FURTHER INFORMATION CONTACT: Christine A. Sannerud, Ph.D., Chief, 
Drug and Chemical Evaluation Section, Office of Diversion Control, Drug 
Enforcement Administration, 8701 Morrissette Drive, Springfield, VA 
22152 at (202) 307-7183.

SUPPLEMENTARY INFORMATION: The DEA is extremely concerned with the 
recent increase in the illicit manufacture and distribution of 
fentanyl, which has resulted in hundreds of fentanyl-related overdoses 
and fentanyl-related deaths in several areas of the country. Therefore, 
on April 9, 2008, DEA published a Notice of Proposed Rulemaking (NPRM) 
[73 FR 19175] to designate the precursor chemical, 4-anilino-N-
phenethyl-4-piperidine (ANPP) as an immediate precursor for the 
schedule II controlled substance fentanyl under the definition set 
forth in 21 U.S.C. 802(23). This rulemaking finalizes that NPRM.
    Under the immediate precursor provision in 21 U.S.C. 811(e), DEA 
may 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). Because of the 
authority in section 811(e), 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).
    This rulemaking finalizes two actions. It (1) designates the 
precursor chemical ANPP 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 ANPP as a schedule II substance 
pursuant to the authority in 21 U.S.C. 811(e).

Background

    Fentanyl is a schedule II controlled substance. Fentanyl and 
analogues of fentanyl are the most potent opioids available for human 
and veterinary use. Fentanyl produces opioid effects that are 
indistinguishable from morphine or heroin, but fentanyl has a greater 
potency and a shorter duration of action. Fentanyl is approximately 50 
to 100 times more potent than morphine and 30 to 50 times more potent 
than heroin, depending on the physiological or behavioral measure, the 
route of administration, and other factors.
    The legitimate medical use of fentanyl is for anesthesia and 
analgesia, but fentanyl's euphoric effects are highly sought after by 
narcotic addicts. Fentanyl can serve as a direct pharmacological 
substitute for heroin in opioid-dependent individuals. Fentanyl is a 
very dangerous substitute for heroin, however, because the amount that 
produces a euphoric effect also induces respiratory depression. 
Furthermore, due to fentanyl's greater potency, illicit drug dealers 
have trouble adjusting (``cutting'') pure fentanyl into non-lethal 
dosage concentrations. Heroin users similarly have difficulty 
determining how much to take to get their ``high'' and sometimes 
mistakenly take a lethal quantity of the fentanyl. Unfortunately, only 
a slight excess of fentanyl can be, and is often, lethal because the 
resulting level of respiratory depression is sufficient to cause the 
user to stop breathing.

Illicit Fentanyl-Related Deaths

    In 2005 and 2006, DEA saw a sharp increase in the seizures of 
illicit fentanyl. The distribution of illicit fentanyl or illicit 
fentanyl combined with heroin or with cocaine (i.e., a ``speedball'') 
resulted in an outbreak of hundreds of confirmed and suspected 
fentanyl-related overdose deaths in the United States since April 2005, 
according to the Centers for Disease Control and Prevention and medical 
examiners representing numerous cities and counties across the United 
States. DEA terms fentanyl-related deaths ``suspected'' until confirmed 
through the completion of an autopsy, a positive toxicological testing 
result for fentanyl in the blood and the reporting of the death to the 
DEA.
    To address this emergency health situation, DEA published an 
Interim Final Rule, ``Control of a Chemical Precursor Used in the 
Illicit Manufacture of Fentanyl as a List I Chemical'' (72 FR 20039, 
April 23, 2007), followed by a Final Rule (73 FR 43355, July 25, 2008), 
to control N-phenethyl-4-piperidone (NPP), the chemical precursor to 
ANPP, as a List I chemical. As DEA discussed extensively in that 
Interim Final Rule, at least 972 confirmed fentanyl-related deaths, and 
162 suspected fentanyl-related deaths, mostly in Delaware, Illinois, 
Maryland, Michigan, Missouri, New Jersey, and Pennsylvania were 
initially reported to the DEA. The number of fentanyl- related deaths 
significantly decreased after October 2006 and continued at lower 
levels following control of the precursor NPP in 2007.
    From the information and data collected, there is a strong 
indication that the fentanyl in these confirmed and suspected fentanyl-
related deaths is the result of illicitly manufactured fentanyl, rather 
than from fentanyl diverted from legal pharmaceutical manufacturers. 
Forensic testing of seized fentanyl drug exhibits can identify 
manufacture procedure markers such as benzylfentanyl and ANPP. The 
forensic data suggests that most of these fentanyl-related deaths are 
from fentanyl illicitly manufactured by the procedure called the 
Siegfried method, discussed in DEA's Interim Final Rule, which uses 
NPP/ANPP.

Synthesis of Fentanyl

    DEA has determined from the forensic testing of seized illicit 
fentanyl that two primary synthesis routes (i.e., the Janssen synthesis 
route and the Siegfried method) are being used to produce fentanyl 
clandestinely. In 1965, Janssen Pharmaceutical patented the original 
synthesis procedure for fentanyl. The Janssen synthesis route is 
difficult to perform and is beyond the rudimentary skills of most 
clandestine laboratory operators. Only individuals who have acquired 
advanced chemistry knowledge and skills have successfully used this 
synthesis route. Forensic laboratories can determine whether fentanyl 
was manufactured illicitly by the Janssen route by detecting the 
impurity benzylfentanyl in the tested fentanyl drug exhibit.
    In the early 1980s, an alternate route for fentanyl synthesis was 
published in the scientific literature; it uses N-phenethyl-4-
piperidone (NPP) as the starting material. The NPP synthesis route is 
described on the Internet and is referred to as the Siegfried method. 
The chemical intermediary ANPP is produced during the synthesis and is 
the immediate precursor used in the illicit manufacture of fentanyl in 
the last stage of the Siegfried method. The Chemical Abstracts Service 
Registry Number \1\ (CASRN) for ANPP is 21409-26-7. The detection of 
the impurity 4-anilino-N-phenethyl-4-piperidine (ANPP) without the 
presence of benzylfentanyl in the fentanyl drug exhibit suggests that 
the fentanyl was manufactured by the Siegfried method (or a modified 
version) that produces

[[Page 37297]]

the precursor ANPP and then converts ANPP directly to fentanyl. (A 
small amount of ANPP is not consumed in the last reaction in the 
synthesis, and thus a trace amount of ANPP remains in the fentanyl.)
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    \1\ The Chemical Abstracts Service Registry Number (CASRN) is 
created by the Chemical Abstracts Service (CAS) Division of the 
American Chemical Society and is part of an automated information 
system housing data and information on specific, definable chemical 
substances. The CASRN provides consistent and unambiguous 
identification of chemicals and facilitates sharing of chemical 
information.
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    The increase in street-level fentanyl may be the result of the 
relative ease with which fentanyl can be produced via the Siegfried 
method and the widespread distribution of the Siegfried method on the 
Internet. Preliminary data indicate that the majority of the deaths in 
the 2005-2006 fentanyl outbreak have resulted from the distribution of 
illicit fentanyl made by the Siegfried method and marked by traces of 
ANPP rather than benzylfentanyl.

Role of ANPP in Synthesis of Fentanyl

    Since 2000, four of the five domestic fentanyl clandestine 
laboratories seized by law enforcement agents have used the Siegfried 
method or a modified version of the Siegfried method in manufacturing 
fentanyl. The amount of illicit fentanyl and precursor chemicals found 
at these four laboratories could have generated a total of 5,800 grams 
of illicit fentanyl. Since fentanyl is potent in sub-milligram 
quantities, the subsequent ``cutting'' of 5,800 grams of illicit 
fentanyl would be sufficient to make about 46 million fentanyl doses.
    The precursor chemical NPP is the starting material utilized in the 
Siegfried method of synthesizing fentanyl, both in industry and in 
illicit drug laboratories. Under a separate rulemaking first published 
as an interim rule on April 23, 2007 (72 FR 20039), followed by a final 
rule on July 25, 2008 (73 FR 43355), DEA has controlled the precursor 
NPP as a List I chemical under the regulatory control provisions of the 
CSA (21 CFR part 1300).
    During the production process, the starting material, NPP, is 
subjected to a series of chemical reactions in order to produce the 
intermediary chemical ANPP. The ANPP is then subjected to a simple 
chemical reaction resulting in the synthesis of fentanyl. DEA has not 
identified any industrial uses for ANPP and believes that ANPP is only 
produced as a chemical intermediary in the production of fentanyl, 
either in the legitimate production of pharmaceutical fentanyl or the 
illicit production of fentanyl in clandestine laboratories. ANPP is, 
therefore, an immediate chemical intermediary in the synthesis of 
fentanyl and is produced primarily for this purpose.
    DEA is controlling ANPP as a schedule II controlled substance in an 
effort to prevent its use in production of illicit fentanyl. DEA 
believes control is necessary to prevent unscrupulous chemists from 
synthesizing and distributing ANPP (as an unregulated material), and 
selling it through the Internet and other channels to individuals who 
may wish to acquire an unregulated precursor for fentanyl synthesis. 
DEA believes this action is also advisable in order to deter the theft 
of ANPP from legitimate pharmaceutical firms where it is generated in 
the course of fentanyl production. It has been determined by DEA's 
Office of Forensic Sciences that ANPP can also be produced through 
synthetic pathways that do not require NPP as the starting material. 
Therefore, DEA believes that controlling ANPP directly is necessary to 
prevent the illicit production of fentanyl.

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.

    DEA finds that ANPP meets the three criteria for the definition of 
an immediate precursor under 21 U.S.C 802(23). First, DEA finds that 
ANPP is produced primarily for use in the manufacture of the schedule 
II controlled substance fentanyl. As stated in the preceding section, 
under the Siegfried method, ANPP is typically produced from the 
starting material NPP and is then subjected to a simple one-step 
chemical reaction to obtain the schedule II controlled substance 
fentanyl. DEA has not identified any industrial or other uses for ANPP 
and believes that it is produced primarily during the synthesis of 
fentanyl.
    Second, DEA finds that ANPP is an immediate chemical intermediary 
used in the manufacture of the controlled substance fentanyl. As stated 
earlier, ANPP is produced as an intermediary in the fentanyl synthetic 
pathway. After it is synthesized, the ANPP is subjected to a simple 
chemical reaction that converts it directly to fentanyl.
    Third, DEA finds that controlling ANPP is necessary to prevent, 
curtail, and limit the unlawful manufacture of the controlled substance 
fentanyl. As noted above, DEA believes this action is necessary to 
assist in preventing the possible theft of ANPP from legitimate 
pharmaceutical firms where it is a chemical intermediary generated for 
fentanyl production. As a schedule II substance, ANPP will be 
safeguarded to the same degree that pharmaceutical firms now safeguard 
the fentanyl that they produce. DEA believes this increased level of 
security is necessary to prevent diversion of ANPP.
    As noted previously, ANPP can also be produced through synthetic 
pathways that do not require NPP as the precursor material. 
Accordingly, DEA believes control is necessary to prevent unscrupulous 
chemists from synthesizing ANPP and selling it (as an unregulated 
material) through the Internet and other channels to individuals who 
may wish to acquire an unregulated precursor for fentanyl synthesis, in 
order to circumvent the regulation of NPP as a List I chemical.
    DEA believes that the control of ANPP is necessary to prevent its 
production and use in the illicit production of fentanyl. Therefore, 
DEA is designating ANPP as an immediate precursor of fentanyl 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

    Under the authority in 21 U.S.C. 811(e), once ANPP 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 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(c) \2\ or the

[[Page 37298]]

findings required for placement in schedule II in section 812(b)(2).\3\
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    \2\ Under administrative scheduling of a substance pursuant to 
21 U.S.C. 811(c), DEA must consider the ``factors determinative of 
control.'' The DEA must consider the following factors with respect 
to each drug or other substance proposed to be controlled in a 
schedule:
    (1) Its actual or relative potential for abuse;
    (2) Scientific evidence of its pharmacological effect, if known;
    (3) The state of current scientific knowledge regarding the drug 
or other substance;
    (4) Its history and current pattern of abuse;
    (5) The scope, duration, and significance of abuse;
    (6) What, if any, risk there is to the public health;
    (7) Its psychic or physiological dependence liability; and
    (8) Whether the substance is an immediate precursor of a 
substance already controlled.
    21 U.S.C. 811(e) specifies that none of these factors must be 
considered, however, in the control of an ``immediate precursor.''
    \3\ The findings for schedule II include (A) the drug or other 
substance has a high potential for abuse; (B) the drug or other 
substance has a currently accepted medical use in treatment in the 
United States or a currently accepted medical use with severe 
restrictions; and (C) abuse of the drug or other substance may lead 
to severe psychological or physical dependence.
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    Based on the finding that ANPP is an ``immediate precursor'' for 
fentanyl, DEA is hereby placing ANPP directly into schedule II.

NPRM Comments

    As part of this NPRM, DEA solicited comments and requested 
information on any possible legitimate uses of ANPP unrelated to 
fentanyl (including industrial uses) to assess the potential commercial 
impact of scheduling ANPP. DEA solicited input from all potentially 
affected parties regarding: (1) The types of legitimate industries 
using ANPP; (2) the legitimate uses of ANPP; (3) the size of the 
domestic market for ANPP; (4) the number of manufacturers of ANPP; (5) 
the number of distributors of ANPP; (6) the level of import and export 
of ANPP; (7) the potential burden these proposed regulatory controls of 
ANPP 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 ANPP by industry and others. DEA invited all interested parties to 
provide any information on any legitimate uses of ANPP in industry, 
commerce, academia, research and development, or other applications.
    In response to the NPRM, DEA received only one comment. The 
commenter expressed concerns that the Aggregate Production Quotas for 
ANPP would need to take into account production losses that are 
inherent in the manufacture of fentanyl. Additionally, the commenter 
expressed concerns that the effective date of the rulemaking may 
adversely impact the timetable for production of fentanyl, since 
manufacturers would be required to obtain ANPP registrations and 
manufacturing quotas prior to being able to produce fentanyl.
    In response to this comment, DEA recognizes that the ANPP Aggregate 
Production Quota must be established at a level that allows adequate 
production losses. Additionally, DEA is aware of the concerns of 
fentanyl manufacturers and will use its best efforts to minimize the 
impact of the new ANPP regulations on the legitimate production of 
fentanyl for medical use. Any person who manufactures, distributes, 
imports, exports, engages in research or conducts instructional 
activities with ANPP, or who desires to manufacture, distribute, 
import, export, engage in instructional activities or conduct research 
with ANPP, must be registered to conduct such activities in accordance 
with part 1301 of Title 21 of the Code of Federal Regulations. Current 
bulk manufacturers, importers, and exporters of ANPP must submit an 
application for registration or an application to amend an existing 
registration to include ANPP on or before August 30, 2010 and may 
continue their activities until DEA has approved or denied that 
application.

Requirements for Handling Schedule II Substances

    This rulemaking finalizes two actions. It (1) designates the 
precursor chemical ANPP 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 ANPP as a schedule II substance 
pursuant to the authority in 21 U.S.C. 811(e).
    The scheduling of ANPP as an immediate precursor will subject ANPP 
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.
    DEA has not identified any legitimate industrial use for ANPP, 
other than its role as an intermediary chemical in the production of 
fentanyl by the pharmaceutical industry. If ANPP is used only to 
manufacture fentanyl, the regulation of ANPP as an immediate precursor 
will not represent a new, major regulatory burden because fentanyl 
manufacturers have already implemented the CSA requirements for 
schedule II substances. For example, since fentanyl is a schedule II 
controlled substance, these firms will already be schedule II 
registrants and will already have adequate schedule II security. As a 
result of this rulemaking, these firms will need to begin storing ANPP 
under the same security controls already used for the final product 
fentanyl. The impact upon legitimate industry of controlling ANPP as a 
schedule II substance should be minimal. The regulatory requirements 
will include the following:
    Registration. Any person who manufactures, distributes, imports, 
exports, engages in research or conducts instructional activities with 
ANPP, or who desires to manufacture, distribute, import, export, engage 
in instructional activities or conduct research with ANPP, must be 
registered to conduct such activities in accordance with 21 CFR part 
1301. Current bulk manufacturers, importers and exporters of ANPP must 
submit an application for registration or an application to amend an 
existing registration to include ANPP on or before August 30, 2010 and 
may continue their activities until DEA has approved or denied that 
application.
    Security. ANPP will be subject to schedule II security 
requirements. To prevent diversion, ANPP will 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.
    This rule does not establish any new security requirements for 
schedule II controlled substances. The following existing security 
requirements are provided for informational purposes only.
    Existing DEA physical security regulations require that, for 
schedule I and II controlled substances, raw material, bulk materials 
awaiting further processing, and finished products be stored in either 
a safe or steel cabinet (if the quantity is small) or in a vault (21 
CFR 1301.72). DEA regulations set forth specific requirements regarding 
these structures. Controlled substances must be stored in these 
facilities during the manufacturing process except where a continuous 
manufacturing process should not be interrupted (21 CFR 1301.73). 
Secure storage areas are required to have an alarm system which, upon 
attempted unauthorized entry, shall transmit a signal directly to a 
central protection company or to a local or state police agency which 
has a legal duty to respond, or a 24-hour control station operated by 
the registrant, or other protection as approved by DEA (21 CFR 
1301.72(a)(1)(iii), 1301.72(a)(3)(iv)). The controlled substances 
storage areas are required to be accessible only to an absolute minimum 
number of specifically authorized employees (21 CFR 1301.72(d)). When 
it is necessary for other personnel or guests to be present

[[Page 37299]]

in, or pass through, such secure areas, the registrant shall provide 
for adequate observation of the area by an employee (21 CFR 1301.72(d), 
1301.73(c)).
    Labeling and Packaging. All labels and labeling for commercial 
containers of ANPP that are distributed will be required to comply with 
the requirements of 21 CFR 1302.03-1302.07.
    Quotas. Quotas for ANPP will be established pursuant to 21 CFR part 
1303.
    Inventory. Every registrant who possesses any quantity of ANPP 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.
    Records. All registrants will be required to keep records pursuant 
to 21 CFR 1304.03, 1304.04, and 1304.21-1304.23.
    Reports. All registrants will be required to submit reports in 
accordance with 21 CFR 1304.33.
    Orders. All registrants involved in the distribution of ANPP will 
be required to comply with the order requirements of 21 CFR part 1305.
    Importation and Exportation. All registrants involved in the 
importation and exportation of ANPP will be required to comply with 21 
CFR part 1312.
    Prescriptions. All prescriptions for ANPP or prescriptions for 
products containing ANPP will be required to be issued pursuant to 21 
CFR 1306.03-1306.06 and 21 CFR Sec. Sec.  1306.11-1306.15.
    Criminal Liability. Any activity with ANPP 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 Certifications

Regulatory Flexibility and Small Business Concerns

    The Regulatory Flexibility Act (5 U.S.C. 601-612) requires agencies 
to determine whether a rule will have a significant economic impact on 
a substantial number of small entities. If an agency finds that there 
is a significant economic impact on a substantial number of small 
entities, the agency must consider whether alternative approaches could 
mitigate the impact on small entities. The size criteria for small 
entities are defined by the Small Business Administration in 13 CFR 
121.201.
    DEA has not identified any legitimate industrial use for ANPP, 
other than its role as an intermediary chemical in the production of 
fentanyl by the pharmaceutical industry. DEA has not identified any 
firms that import, export, or distribute ANPP. If ANPP is used only to 
manufacture fentanyl, the potential regulation of ANPP as an immediate 
precursor will not represent a new, major regulatory burden, because 
fentanyl manufacturers have already implemented the CSA requirements 
for the handling of schedule II substances. Consequently, DEA believes 
this rule will not have a significant economic impact on a substantial 
number of small entities. DEA did not receive any comments suggesting 
that this rule will result in a significant economic impact on any 
small entities.

Executive Order 12866

    The Deputy Administrator certifies that this rulemaking has been 
drafted in accordance with the principles in Executive Order 12866 
Sec.  1(b). It has been determined that this is ``a significant 
regulatory action.'' Therefore, this action has been reviewed by the 
Office of Management and Budget.
    DEA is regulating ANPP as a schedule II substance. Any person 
manufacturing, distributing, dispensing, conducting research with, 
importing, or exporting ANPP will have to register each location where 
ANPP is handled, maintain records of transactions involving ANPP, and 
take steps to ensure that inventories are secure (e.g., stored in 
sealed containers in areas where access can be controlled or 
monitored). DEA has not identified any domestic chemical companies that 
distribute ANPP, other than the production as an intermediate during 
the manufacture of fentanyl. Such manufacturers are already registered 
with DEA for the schedule II drug fentanyl.

Executive Order 12988

    This regulation meets the applicable standards set forth in 
Sec. Sec.  3(a) and 3(b)(2) of Executive Order 12988 Civil Justice 
Reform.

Executive Order 13132

    This rulemaking does not preempt or modify any provision of state 
law; nor does it impose enforcement responsibilities on any state; nor 
does it diminish the power of any state to enforce its own laws. 
Accordingly, this rulemaking does not have federalism implications 
warranting the application of Executive Order 13132.

Unfunded Mandates Reform Act of 1995

    This rule will not result in the expenditure by state, local, and 
tribal governments, in the aggregate, or by the private sector, of 
$120,000,000 or more (adjusted for inflation) in any one year, and will 
not significantly or uniquely affect small governments. Therefore, no 
actions are deemed necessary under the provisions of the Unfunded 
Mandates Reform Act of 1995.

Congressional Review Act

    This rule is not a major rule as defined by Section 804 of the 
Small Business Regulatory Enforcement Fairness Act of 1996 
(Congressional Review Act). This rule will not result in an annual 
effect on the economy of $100,000,000 or more; a major increase in cost 
or prices; or significant adverse effects on competition, employment, 
investment, productivity, innovation, or on the ability of United 
States-based companies to compete with foreign-based companies in 
domestic and export markets.

List of Subjects in 21 CFR Part 1308

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

0
For the reasons set out above, 21 CFR part 1308 is amended as follows:

PART 1308--SCHEDULES OF CONTROLLED SUBSTANCES

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

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


0
2. Section 1308.12 is amended by adding a new paragraph (g)(3) to read 
as follows:


Sec.  1308.12  Schedule II.

* * * * *
    (g) * * *
    (3) Immediate precursor to fentanyl:

(i) 4-anilino-N-phenethyl-4-piperidine (ANPP)..................     8333
 

    (ii) [Reserved]

    Dated: June 19, 2010.
Michele M. Leonhart,
Deputy Administrator.
[FR Doc. 2010-15520 Filed 6-28-10; 8:45 am]
BILLING CODE 4410-09-P