Rules - 2010
FR Doc 2010-15520[Federal Register: June 29, 2010 (Volume 75, Number 124)]
[Rules and Regulations]
[Page 37295-37299]
From the Federal Register Online via GPO Access [wais.access.gpo.gov]
[DOCID:fr29jn10-8]
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.
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.
For the reasons set out above, 21 CFR part 1308 is amended as follows:
PART 1308--SCHEDULES OF CONTROLLED SUBSTANCES
1. The authority citation for part 1308 continues to read as follows:
Authority: 21 U.S.C. 811, 812, 871(b) unless otherwise noted.
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
NOTICE: This is an unofficial version. An official version of this publication may be obtained
directly from the Government Printing Office (GPO). |
