[Federal Register: April 9, 2008 (Volume 73, Number 69)]
[Proposed Rules]
[Page 19175-19179]
From the Federal Register Online via GPO Access [wais.access.gpo.gov]
[DOCID:fr09ap08-14]
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DEPARTMENT OF JUSTICE
Drug Enforcement Administration
21 CFR Part 1308
[Docket No. DEA-305P]
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: Notice of Proposed Rulemaking.
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SUMMARY: The Drug Enforcement Administration (DEA) is proposing 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. Sec.
802(23). Furthermore, DEA is proposing to control 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 the need of addressing the ``factors determinative of
control'' in 21 U.S.C. Sec. 811 or the findings required in 21 U.S.C.
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.
The distribution of illicitly manufactured fentanyl has caused an
unprecedented outbreak of hundreds of fentanyl-related overdoses in the
United States in recent months. 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: Written comments must be postmarked, and electronic comments
must be sent, on or before June 9, 2008.
ADDRESSES: To ensure proper handling of comments, please reference
``Docket No. DEA-305'' on all written and electronic correspondence.
Written comments via regular mail should be sent to the Deputy
Assistant Administrator, Office of Diversion Control, Drug Enforcement
Administration, Washington, DC 20537, Attention: DEA Federal Register
Representative/ODL. Written comments sent via express mail should be
sent to DEA Headquarters, Attention: DEA Federal Register
Representative/ODL, 8701 Morrissette Drive, Springfield, VA 22152.
Comments may be sent directly to DEA electronically by sending an
electronic message to dea.diversion.policy@usdoj.gov. Comments may also
be sent electronically through http://www.regulations.gov using the
electronic comment form provided on that site. An electronic copy of
this document is also available at the http://www.regulations.gov Web
site. DEA will accept attachments to electronic comments in Microsoft
Word, WordPerfect, Adobe PDF, or Excel file formats. DEA will not
accept any file format other than those specifically listed here.
Posting of Public Comments: Please note that all comments received
are considered part of the public record and made available for public
inspection online at http://www.regulations.gov and in the Drug
Enforcement Administration's public docket. Such information includes
personal identifying information (such as your name, address, etc.)
voluntarily submitted by the commenter.
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 posted online or made available in the public docket, you must
include the phrase ``PERSONAL IDENTIFYING INFORMATION'' in the first
paragraph of your comment. You must also place all the personal
identifying information you do not want posted online or made available
in the public docket 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 posted online or made available
in the public docket, you must include the phrase ``CONFIDENTIAL
BUSINESS INFORMATION'' in the first paragraph of your comment. You must
also prominently identify confidential business information to be
redacted within the comment. If a comment has so much confidential
business information that it cannot be effectively redacted, all or
part of that comment may not be posted online or made available in the
public docket.
Personal identifying information and confidential business
information identified and located as set forth above will be redacted
and the comment, in redacted form, will be posted online and placed in
the Drug Enforcement Administration's public docket file. Please note
that the Freedom of Information Act applies to all comments received.
If you wish to inspect the agency's public docket file in person by
appointment, please see the FOR FURTHER INFORMATION CONTACT paragraph.
FOR FURTHER INFORMATION CONTACT: Christine A. Sannerud, PhD, Chief,
Drug and Chemical Evaluation Section, Office of Diversion Control, Drug
Enforcement Administration, Washington, DC 20537 at (202) 307-7183.
SUPPLEMENTARY INFORMATION: The Drug Enforcement Administration (DEA) is
extremely concerned with the recent increase in the illicit manufacture
and distribution of fentanyl, which has
[[Page 19176]]
resulted in hundreds of fentanyl-related overdoses and fentanyl-related
deaths in several areas of the country. DEA is proposing 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).
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), and accordingly, DEA is
not seeking comment on those factors and/or findings in this NPRM.
This rulemaking proposes two actions. It (1) proposes the
designation of 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) proposes control of
ANPP as a schedule II substance pursuant to the authority in 21 U.S.C.
811(e). DEA is soliciting comment on these two proposed actions, as
well as on any possible legitimate uses of ANPP that are unrelated to
fentanyl (including industrial uses) in order to assess the potential
commercial impact of scheduling ANPP.
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 (CDC) 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) 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 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 current fentanyl outbreak have resulted from the distribution of
[[Page 19177]]
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 published April
23, 2007 (72 FR 20039), 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 proposing to control 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 proposing the designation of ANPP as an immediate precursor of
fentanyl 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
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'' Sec. 811(a) or section 812(b) and ``without
regard to the procedures'' prescribed by section 811(a) and (b).
Accordingly, DEA need not address the ``factors determinative of
control'' in section 811 or the findings required for placement in
schedule II in section 812(b)(2).\2\
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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.''
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Furthermore, if ANPP is designated as an ``immediate precursor''
for the schedule II controlled substance fentanyl, section 811(e)
specifies that DEA does not need to make the findings
[[Page 19178]]
required under section 812(b)(2) for schedule II controlled
substances.\3\
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\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 proposes to place ANPP directly into schedule II.
Therefore, DEA is not seeking comments regarding these factors and
findings.
Requirements for Handling Schedule II Substances
The proposed scheduling of ANPP as an immediate precursor would
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. Therefore, DEA is soliciting comment from
manufacturers, distributors, importers, exporters, and researchers on
the regulatory burden to legitimate commercial activities that would
result from the proposed placement of ANPP in schedule II of the CSA.
To date 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 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 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. If ANPP is placed in schedule
II, the regulatory requirements will include the following:
Registration. Any person who manufactures, distributes, dispenses,
imports, or exports ANPP, engages in research with respect to ANPP, or
proposes to engage in such activities would be required to submit an
application for schedule II registration in accordance with 21 CFR part
1301.
Security. ANPP would be subject to schedule II security
requirements. In order to prevent diversion, ANPP 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.
This rule does not propose 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 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 would be required to comply
with the requirements of 21 CFR 1302.03-1302.07.
Quotas. Quotas for ANPP would be established pursuant to 21 CFR
part 1303.
Inventory. Every registrant who possesses any quantity of ANPP
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.
Records. All registrants would be required to keep records pursuant
to 21 CFR 1304.03, 1304.04, and 1304.21-1304.23.
Reports. All registrants would be required to submit reports in
accordance with 21 CFR 1304.33.
Orders. All registrants involved in the distribution of ANPP would
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 would be required to comply with 21
CFR part 1312.
Prescriptions. All prescriptions for ANPP or prescriptions for
products containing ANPP would be required to be issued pursuant to 21
CFR 1306.03-1306.06 and 21 CFR 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 would be unlawful and potentially
subject to criminal penalties (21 U.S.C. Sec. Sec. 841-863 and 959-
964).
Solicitation of Information
As part of this rulemaking, DEA is soliciting information on any
possible legitimate uses of ANPP unrelated to fentanyl (including
industrial uses) in order to assess the potential commercial impact of
scheduling ANPP. DEA has searched information in the public domain for
legitimate uses of ANPP and has not documented any legitimate
commercial uses for ANPP other than as an intermediary chemical in the
production of fentanyl. DEA seeks, however, to document any
unpublicized use(s) and other proprietary use(s) of ANPP that are not
in the public domain. Therefore, DEA is soliciting comment on the uses
of ANPP in the legitimate marketplace.
DEA is soliciting 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 invites all interested parties to
provide any information on any legitimate uses of ANPP in industry,
commerce, academia, research and
[[Page 19179]]
development, or other applications. 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 Certifications
Regulatory Flexibility and Small Business Concerns
The Regulatory Flexibility Act (5 U.S.C. 601-612) requires agencies
to determine whether a proposed 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 (SBA)
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
the proposed rule will not have a significant economic impact on a
substantial number of small entities. However, DEA is nonetheless
seeking comment on whether there are uses for ANPP not known to DEA
that could be impaired by this proposed rule and result in a
significant economic impact on a substantial number of small entities.
Executive Order 12988
This regulation meets the applicable standards set forth in
sections 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 proposed to be
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 proposed to be 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: March 14, 2008.
Michele M. Leonhart,
Deputy Administrator.
[FR Doc. E8-7391 Filed 4-8-08; 8:45 am]
BILLING CODE 4410-09-P