Federal
Register Notices > Rules - 200 8
-
Control of Immediate Precursor Used in the Illicit
Manufacture of Fentanyl as a Schedule II Controlled Substance
FR Doc E8-7391[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]
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.
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
NOTICE: This is an
unofficial version. An official version of these publications may be obtained
directly from the Government Printing Office (GPO).
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