Control of Immediate Precursor Used in the Illicit Manufacture of Fentanyl as a Schedule II Controlled Substance, 19175-19179 [E8-7391]

Agencies

• Drug Enforcement Administration
• Department of Justice

[Federal Register Volume 73, Number 69 (Wednesday, April 9, 2008)]
[Proposed Rules]
[Pages 19175-19179]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: E8-7391]


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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 https://www.regulations.gov using the 
electronic comment form provided on that site. An electronic copy of 
this document is also available at the https://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 https://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