Control of a Chemical Precursor Used in the Illicit Manufacture of Fentanyl as a List I Chemical, 43355-43357 [E8-17034]
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Federal Register / Vol. 73, No. 144 / Friday, July 25, 2008 / Rules and Regulations
Effective Date: This amendment
will become effective on October 1,
2008.
DATES:
Requests for copies of this
document should be sent to: Public
Reference Branch, Federal Trade
Commission, Room 130, 600
Pennsylvania Avenue, NW.,
Washington, DC 20580. Copies of this
document are also available on the
Internet at the Commission’s Web site:
https://www.ftc.gov.
FOR FURTHER INFORMATION CONTACT:
Kelly A. Horne, (202) 326–3031,
Division of Planning & Information,
Bureau of Consumer Protection, Federal
Trade Commission, 600 Pennsylvania
Avenue, NW., Washington, DC 20580.
SUPPLEMENTARY INFORMATION: To comply
with the Do-Not-Call Registry Fee
Extension Act of 2007 (Pub. L. 110–188,
122 Stat. 635) (‘‘Act’’), the Commission
is revising the Final Amended Fee Rule
in the following manner: The revised
rule decreases the annual fee for access
to the Registry for each area code of data
to $54 per area code, or $27 per area
code of data during the second six
months of an entity’s annual
subscription period. The maximum
amount that would be charged to any
single entity for accessing area codes of
data is decreased to $14,850. The
revised rule retains the provisions
regarding free access to the first five area
codes of data by all entities, as well as
free access by ‘‘exempt’’ organizations.
As required by the Act, it expands the
definition of ‘‘exempt’’ organizations to
include any person permitted to access,
but not required to access, the do-notcall registry, not only under the TSR,
the Federal Communication
Commission’s do-not-call rules found at
47 CFR 64.1200, or any other Federal
law, but also under any other Federal
regulation.
Additionally, in accordance with the
Act, beginning after fiscal year 2009, the
dollar amounts charged shall be
increased by an amount equal to the
amounts specified in the Final
Amended Fee Rule, whichever fee is
applicable, multiplied by the percentage
(if any) by which the average of the
monthly consumer price index (for all
urban consumers published by the
Department of Labor) (‘‘CPI’’) for the
most recently ended 12-month period
ending on June 30 exceeds the CPI for
the 12-month period ending June 30,
2008. Any increase shall be rounded to
the nearest dollar. There shall be no
increase in the dollar amounts if the
change in the CPI is less than 1 percent.
The adjustments to the applicable fees,
if any, shall be published in the Federal
jlentini on PROD1PC65 with RULES
ADDRESSES:
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Register no later than September 1 of
each year.
Administrative Procedure Act;
Regulatory Flexibility Act; Paperwork
Reduction Act
The revisions to the Fee Rule are
technical in nature and merely
incorporate statutory changes to the
TSR. These statutory changes have been
adopted without change or
interpretation at this time, making
public comment unnecessary.
Therefore, the Commission has
determined that the notice and
comment requirements of the
Administrative Procedure Act do not
apply. See 5 U.S.C. 553(b). For this
reason, the requirements of the
Regulatory Flexibility Act also do not
apply. See 5 U.S.C. 603, 604.
Pursuant to the Paperwork Reduction
Act, 44 U.S.C. 3501–3521, the Office of
Management and Budget (‘‘OMB’’)
approved the information collection
requirements in the Amended TSR and
assigned the following existing OMB
Control Number: 3084–0097. The
amendments outlined in this Final Rule
pertain only to the fee provision (sec.
310.8) of the Amended TSR and will not
establish or alter any recordkeeping,
reporting, or third-party disclosure
requirements elsewhere in the Amended
TSR.
I Accordingly, the Federal Trade
Commission amends part 310 of title 16
of the Code of Federal Regulations as
follows:
PART 310—TELEMARKETING SALES
RULE
1. The authority citation for part 310
continues to read as follows:
I
Authority: 15 U.S.C. 6101–6108; 15 U.S.C.
6151–6155.
2. Revise §§ 310.8(c) and (d) to read as
follows:
I
§ 310.8 Fee for access to the National Do
Not Call Registry.
*
*
*
*
*
(c) The annual fee, which must be
paid by any person prior to obtaining
access to the National Do Not Call
Registry, is $54 for each area code of
data accessed, up to a maximum of
$14,850; provided, however, that there
shall be no charge to any person for
accessing the first five area codes of
data, and provided further, that there
shall be no charge to any person
engaging in or causing others to engage
in outbound telephone calls to
consumers and who is accessing area
codes of data in the National Do Not
Call Registry if the person is permitted
to access, but is not required to access,
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43355
the National Do Not Call Registry under
this Rule, 47 CFR 64.1200, or any other
Federal regulation or law. Any person
accessing the National Do Not Call
Registry may not participate in any
arrangement to share the cost of
accessing the registry, including any
arrangement with any telemarketer or
service provider to divide the costs to
access the registry among various clients
of that telemarketer or service provider.
(d) Each person who pays, either
directly or through another person, the
annual fee set forth in § 310.8(c), each
person excepted under § 310.8(c) from
paying the annual fee, and each person
excepted from paying an annual fee
under § 310.4(b)(1)(iii)(B), will be
provided a unique account number that
will allow that person to access the
registry data for the selected area codes
at any time for the twelve month period
beginning on the first day of the month
in which the person paid the fee (‘‘the
annual period’’). To obtain access to
additional area codes of data during the
first six months of the annual period,
each person required to pay the fee
under § 310.8(c) must first pay $54 for
each additional area code of data not
initially selected. To obtain access to
additional area codes of data during the
second six months of the annual period,
each person required to pay the fee
under § 310.8(c) must first pay $27 for
each additional area code of data not
initially selected. The payment of the
additional fee will permit the person to
access the additional area codes of data
for the remainder of the annual period.
*
*
*
*
*
By direction of the Commission.
Donald S. Clark,
Secretary.
[FR Doc. E8–17064 Filed 7–24–08; 8:45 am]
BILLING CODE 6750–01–P
DEPARTMENT OF JUSTICE
Drug Enforcement Administration
21 CFR Part 1310
[Docket No. DEA–299F]
RIN 1117–AB12
Control of a Chemical Precursor Used
in the Illicit Manufacture of Fentanyl as
a List I Chemical
Drug Enforcement
Administration (DEA), Department of
Justice.
ACTION: Final rule.
AGENCY:
SUMMARY: The Drug Enforcement
Administration (DEA) is finalizing the
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43356
Federal Register / Vol. 73, No. 144 / Friday, July 25, 2008 / Rules and Regulations
jlentini on PROD1PC65 with RULES
Interim Rule with Request for Comment
published in the Federal Register on
April 23, 2007. The Interim Rule
controlled the chemical N-phenethyl-4piperidone (NPP) as a List I chemical
under the Controlled Substances Act.
Clandestine laboratories are using this
chemical to illicitly manufacture the
schedule II controlled substance
fentanyl. No comments to the Interim
Rule were received. This Final Rule
finalizes the regulations without change.
DATES: Effective Date: July 25, 2008.
FOR FURTHER INFORMATION CONTACT:
Christine A. Sannerud, PhD., Chief,
Drug and Chemical Evaluation Section,
Office of Diversion Control, Drug
Enforcement Administration, 8701
Morrissette Drive, Springfield, Virginia
22152 at (202) 307–7183.
SUPPLEMENTARY INFORMATION:
Background
On April 23, 2007 (72 FR 20039), the
Drug Enforcement Administration
(DEA) published an Interim Rule with
Request for Comment which established
regulations controlling the chemical Nphenethyl-4-piperidone (NPP) as a List
I chemical under the Controlled
Substances Act (CSA). This action was
taken because DEA was extremely
concerned with the increase in the illicit
manufacture and distribution of
fentanyl, which resulted in more than
1,000 confirmed or suspected fentanylrelated overdoses and fentanyl-related
deaths across the country.
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. However, 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 endpoints being
measured, 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. However,
fentanyl is a very dangerous substitute
for heroin because the amount that
produces a euphoric effect also induces
respiratory depression. Furthermore,
due to fentanyl’s increased potency over
heroin, illicit drug dealers have trouble
adjusting (‘‘cutting’’) pure fentanyl into
proper dosage concentrations. As a
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result, drug abusers 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 in
the amount of fentanyl taken can be,
and is often, lethal because the resulting
level of respiratory depression is
sufficient to cause the user to stop
breathing.
In April 2006, DEA issued an officer
safety alert regarding the special
precautions that must be observed when
handling and processing suspected
fentanyl. DEA is concerned with the
unusual health hazards posed to law
enforcement officers and forensic
chemists from exposure to high purity
fentanyl during law enforcement
operations. Since high purity fentanyl
can be fatal if sub-milligram quantities
are accidentally swallowed, inhaled, or
absorbed through the skin, the potential
for lethal fentanyl exposure to law
enforcement officers and chemists exists
during raids of fentanyl clandestine
laboratories, during seizures of drug
exhibits, and during subsequent testing
of pure fentanyl in the forensic
laboratories.
Illicit Manufacture of Fentanyl
As discussed extensively in the
Interim Rule with Request for Comment,
DEA determined from the forensic
testing of seized illicit fentanyl that the
chemical NPP was being used to illicitly
manufacture fentanyl. Since 2000, four
of the five domestic fentanyl clandestine
laboratories seized by law enforcement
have used NPP as starting material to
manufacture the illicit fentanyl. From
these four domestic clandestine
laboratories, about 800 grams equivalent
of pure fentanyl were seized.
Furthermore, enough of the unused NPP
precursor chemical was also seized to
make an additional 5,000 grams of pure
fentanyl. Therefore, from the amount of
illicit fentanyl and precursor chemicals
found at these four domestic fentanyl
laboratories, the laboratories could have
potentially 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.
Three of the domestic fentanyl
clandestine laboratories seized by law
enforcement are known to have
obtained the NPP precursor chemical
from domestic suppliers. The Interim
Rule made the purchase of NPP from
domestic or international suppliers a
regulated transaction. In this way, DEA
will be informed of the sale of NPP and
can take appropriate action, if
necessary. Thus, DEA regulated the
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Sfmt 4700
chemical NPP as a List I chemical under
the CSA (21 U.S.C. 801 et seq.).
Furthermore, under 21 U.S.C § 811(e) of
the CSA, DEA also intends to control
ANPP as a schedule II immediate
precursor to fentanyl under a separate
rulemaking.
Illicit Fentanyl-Related Deaths
The distribution of illicit fentanyl or
illicit fentanyl combined with heroin or
cocaine has resulted in an outbreak of
more than 1,000 confirmed or suspected
fentanyl-related overdoses and fentanylrelated deaths across the country
according to the Centers for Disease
Control and Prevention (CDC) and local
medical examiners. DEA terms fentanylrelated 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. As
discussed in the Interim Rule with
Request for Comment, from the
information and data collected, there is
strong indication that the fentanyl in
these confirmed and suspected fentanylrelated deaths is illicitly manufactured
rather than diverted from legal
pharmaceutical manufacturers. The
current forensic data suggests that most
of these fentanyl-related deaths are from
fentanyl illicitly manufactured using
NPP.
Availability of the Precursor Chemical
DEA determined that the precursor
chemical, NPP, is readily available from
commercial chemical suppliers. DEA
identified at least 62 suppliers of NPP,
of which 14 are located domestically
and 48 are located internationally in
Germany, India, and China. Since 2000,
law enforcement has evidence to
support that the NPP precursor
chemical was obtained from domestic
suppliers for three domestic fentanyl
clandestine laboratories. Further, a
fentanyl clandestine laboratory in
Mexico is believed to have obtained the
NPP precursor chemical from an
international supplier. Law enforcement
identified four separate chemical
suppliers that have distributed NPP to
illicit fentanyl clandestine laboratories.
Regulation of NPP as a List I Chemical
Based on the above, on April 23,
2007, DEA published an Interim Rule
with Request for Comment (72 FR
20039) controlling NPP as a List I
chemical. That rule made the domestic
sale of NPP a regulated transaction. That
rule also made the importation of NPP
from an international supplier a
regulated transaction. Documenting the
domestic sale and importation of NPP is
needed by law enforcement to identify
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Federal Register / Vol. 73, No. 144 / Friday, July 25, 2008 / Rules and Regulations
the domestic diversion of NPP for the
illicit manufacture of fentanyl in the
United States. Finally, that rule
specified that chemical mixtures
containing NPP were not exempt from
regulatory requirements at any
concentration, unless an application for
exemption of a chemical mixture is
submitted by a NPP manufacturer and
the application is reviewed and
accepted by DEA under 21 CFR 1310.13.
Comments Received
DEA did not receive any comments to
its Interim Rule with Request for
Comment (72 FR 20039, April 23, 2007)
controlling NPP as a List I chemical and
regulating all chemical mixtures
containing NPP. Therefore, DEA is
hereby finalizing that Interim Final Rule
without change.
Regulatory Certifications
Administrative Procedure Act (5 U.S.C.
553)
An agency may find good cause to
exempt a rule from certain provisions of
the Administrative Procedure Act (5
U.S.C. 553), including making the rule
effective upon the date of publication.
DEA finds good cause to make this rule
effective upon publication, as this Final
Rule merely confirms existing
regulatory requirements implemented as
part of the Interim Rule with Request for
Comment published April 23, 2007, at
72 FR 20039.
jlentini on PROD1PC65 with RULES
Regulatory Flexibility Act and Small
Business Concerns
The Acting Administrator hereby
certifies that this rulemaking has been
drafted in accordance with the
Regulatory Flexibility Act (5 U.S.C.
605(b)).
Some of the firms DEA identified as
potentially handling NPP are small
entities. The highest cost that the rule
would impose on these firms is less
than $2,500 for registration. The
smallest firm (1 to 4 employees) in the
organic chemical sector has annual
revenues of about $1.1 million. For
those not already registered with DEA,
the cost of registration represents 0.2
percent of annual revenues, which does
not constitute a significant economic
impact. DEA did not receive any
comments to its Interim Rule controlling
NPP as a List I chemical. Therefore, the
Acting Administrator certifies that this
rule will not have a significant
economic impact on a substantial
number of small entities.
Executive Order 12866
The Acting Administrator certifies
that this rulemaking has been drafted in
accordance with the principles in
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16:29 Jul 24, 2008
Jkt 214001
Executive Order 12866 Section 1(b). It
has been determined that this is ‘‘not a
significant regulatory action.’’
Therefore, this action has not been
reviewed by the Office of Management
and Budget.
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.
Paperwork Reduction Act
With publication of the Interim Final
Rule controlling NPP as a List I
chemical (72 FR 20039), persons
handling NPP became subject to CSA
List I regulatory requirements. Any
person who manufactures, distributes,
imports, or exports NPP must register
with DEA. As discussed in the Interim
Rule, DEA has identified 14 domestic
chemical companies who would be
required to register with DEA if they
continued to handle NPP. Persons
wishing to register with DEA to handle
List I chemicals must do so using DEA
Form 510, Application for Registration
under Domestic Chemical Diversion
Control Act of 1993, and persons
wishing to renew their registration must
do so using DEA Form 510a, Renewal
Application for Registration under
Domestic Chemical Diversion Control
Act of 1993 [OMB control # 1117–0031].
With publication of the Interim Rule,
DEA received approval from the Office
of Management and Budget to revise
this information collection as discussed
above.
Persons importing, exporting, and
conducting international transactions
involving NPP must comply with
regulatory requirements regarding the
notification of DEA of pending
transactions. As DEA had no
information on which to estimate how
many of the 14 identified firms import,
export, or conduct international
transactions with NPP, DEA estimated
that all identified firms conduct such
transactions. DEA estimated that each
firm will conduct five import
transactions and two export transactions
annually. DEA did not identify any
firms serving as United States brokers
conducting international transactions
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Fmt 4700
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43357
involving NPP. Therefore, DEA did not
estimate any international transactions
involving NPP. Persons importing,
exporting, and conducting international
transactions involving List I chemicals
report those transactions to DEA on
DEA Form 486, Import/Export
Declaration for List I and List II
chemicals [OMB control # 1117–0023].
With publication of the Interim Rule,
DEA received approval from the Office
of Management and Budget to revise
this information collection as discussed
above.
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 were 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
Congressional Review Act/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 foreignbased companies in domestic and
export markets.
List of Subjects in 21 CFR Part 1310
Drug traffic control, Exports, Imports,
List I and List II chemicals, Reporting
and recordkeeping requirements.
Adoption as Final Rule
The Interim Rule amending part 1310
of Title 21, of the Code of Federal
Regulations, which published in the
Federal Register on April 23, 2007 at 72
FR 20039, is hereby adopted as a Final
Rule without change.
I
Dated: July 17, 2008.
Michele M. Leonhart,
Acting Administrator.
[FR Doc. E8–17034 Filed 7–24–08; 8:45 am]
BILLING CODE 4410–09–P
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]]>Agencies
[Federal Register Volume 73, Number 144 (Friday, July 25, 2008)]
[Rules and Regulations]
[Pages 43355-43357]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: E8-17034]
=======================================================================
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DEPARTMENT OF JUSTICE
Drug Enforcement Administration
21 CFR Part 1310
[Docket No. DEA-299F]
RIN 1117-AB12
Control of a Chemical Precursor Used in the Illicit Manufacture
of Fentanyl as a List I Chemical
AGENCY: Drug Enforcement Administration (DEA), Department of Justice.
ACTION: Final rule.
-----------------------------------------------------------------------
SUMMARY: The Drug Enforcement Administration (DEA) is finalizing the
[[Page 43356]]
Interim Rule with Request for Comment published in the Federal Register
on April 23, 2007. The Interim Rule controlled the chemical N-
phenethyl-4-piperidone (NPP) as a List I chemical under the Controlled
Substances Act. Clandestine laboratories are using this chemical to
illicitly manufacture the schedule II controlled substance fentanyl. No
comments to the Interim Rule were received. This Final Rule finalizes
the regulations without change.
DATES: Effective Date: July 25, 2008.
FOR FURTHER INFORMATION CONTACT: Christine A. Sannerud, PhD., Chief,
Drug and Chemical Evaluation Section, Office of Diversion Control, Drug
Enforcement Administration, 8701 Morrissette Drive, Springfield,
Virginia 22152 at (202) 307-7183.
SUPPLEMENTARY INFORMATION:
Background
On April 23, 2007 (72 FR 20039), the Drug Enforcement
Administration (DEA) published an Interim Rule with Request for Comment
which established regulations controlling the chemical N-phenethyl-4-
piperidone (NPP) as a List I chemical under the Controlled Substances
Act (CSA). This action was taken because DEA was extremely concerned
with the increase in the illicit manufacture and distribution of
fentanyl, which resulted in more than 1,000 confirmed or suspected
fentanyl-related overdoses and fentanyl-related deaths across the
country.
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. However, 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 endpoints being measured, 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. However,
fentanyl is a very dangerous substitute for heroin because the amount
that produces a euphoric effect also induces respiratory depression.
Furthermore, due to fentanyl's increased potency over heroin, illicit
drug dealers have trouble adjusting (``cutting'') pure fentanyl into
proper dosage concentrations. As a result, drug abusers 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 in the amount of fentanyl taken can be, and is often,
lethal because the resulting level of respiratory depression is
sufficient to cause the user to stop breathing.
In April 2006, DEA issued an officer safety alert regarding the
special precautions that must be observed when handling and processing
suspected fentanyl. DEA is concerned with the unusual health hazards
posed to law enforcement officers and forensic chemists from exposure
to high purity fentanyl during law enforcement operations. Since high
purity fentanyl can be fatal if sub-milligram quantities are
accidentally swallowed, inhaled, or absorbed through the skin, the
potential for lethal fentanyl exposure to law enforcement officers and
chemists exists during raids of fentanyl clandestine laboratories,
during seizures of drug exhibits, and during subsequent testing of pure
fentanyl in the forensic laboratories.
Illicit Manufacture of Fentanyl
As discussed extensively in the Interim Rule with Request for
Comment, DEA determined from the forensic testing of seized illicit
fentanyl that the chemical NPP was being used to illicitly manufacture
fentanyl. Since 2000, four of the five domestic fentanyl clandestine
laboratories seized by law enforcement have used NPP as starting
material to manufacture the illicit fentanyl. From these four domestic
clandestine laboratories, about 800 grams equivalent of pure fentanyl
were seized. Furthermore, enough of the unused NPP precursor chemical
was also seized to make an additional 5,000 grams of pure fentanyl.
Therefore, from the amount of illicit fentanyl and precursor chemicals
found at these four domestic fentanyl laboratories, the laboratories
could have potentially 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.
Three of the domestic fentanyl clandestine laboratories seized by
law enforcement are known to have obtained the NPP precursor chemical
from domestic suppliers. The Interim Rule made the purchase of NPP from
domestic or international suppliers a regulated transaction. In this
way, DEA will be informed of the sale of NPP and can take appropriate
action, if necessary. Thus, DEA regulated the chemical NPP as a List I
chemical under the CSA (21 U.S.C. 801 et seq.). Furthermore, under 21
U.S.C Sec. 811(e) of the CSA, DEA also intends to control ANPP as a
schedule II immediate precursor to fentanyl under a separate
rulemaking.
Illicit Fentanyl-Related Deaths
The distribution of illicit fentanyl or illicit fentanyl combined
with heroin or cocaine has resulted in an outbreak of more than 1,000
confirmed or suspected fentanyl-related overdoses and fentanyl-related
deaths across the country according to the Centers for Disease Control
and Prevention (CDC) and local medical examiners. 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. As discussed in the
Interim Rule with Request for Comment, from the information and data
collected, there is strong indication that the fentanyl in these
confirmed and suspected fentanyl-related deaths is illicitly
manufactured rather than diverted from legal pharmaceutical
manufacturers. The current forensic data suggests that most of these
fentanyl-related deaths are from fentanyl illicitly manufactured using
NPP.
Availability of the Precursor Chemical
DEA determined that the precursor chemical, NPP, is readily
available from commercial chemical suppliers. DEA identified at least
62 suppliers of NPP, of which 14 are located domestically and 48 are
located internationally in Germany, India, and China. Since 2000, law
enforcement has evidence to support that the NPP precursor chemical was
obtained from domestic suppliers for three domestic fentanyl
clandestine laboratories. Further, a fentanyl clandestine laboratory in
Mexico is believed to have obtained the NPP precursor chemical from an
international supplier. Law enforcement identified four separate
chemical suppliers that have distributed NPP to illicit fentanyl
clandestine laboratories.
Regulation of NPP as a List I Chemical
Based on the above, on April 23, 2007, DEA published an Interim
Rule with Request for Comment (72 FR 20039) controlling NPP as a List I
chemical. That rule made the domestic sale of NPP a regulated
transaction. That rule also made the importation of NPP from an
international supplier a regulated transaction. Documenting the
domestic sale and importation of NPP is needed by law enforcement to
identify
[[Page 43357]]
the domestic diversion of NPP for the illicit manufacture of fentanyl
in the United States. Finally, that rule specified that chemical
mixtures containing NPP were not exempt from regulatory requirements at
any concentration, unless an application for exemption of a chemical
mixture is submitted by a NPP manufacturer and the application is
reviewed and accepted by DEA under 21 CFR 1310.13.
Comments Received
DEA did not receive any comments to its Interim Rule with Request
for Comment (72 FR 20039, April 23, 2007) controlling NPP as a List I
chemical and regulating all chemical mixtures containing NPP.
Therefore, DEA is hereby finalizing that Interim Final Rule without
change.
Regulatory Certifications
Administrative Procedure Act (5 U.S.C. 553)
An agency may find good cause to exempt a rule from certain
provisions of the Administrative Procedure Act (5 U.S.C. 553),
including making the rule effective upon the date of publication. DEA
finds good cause to make this rule effective upon publication, as this
Final Rule merely confirms existing regulatory requirements implemented
as part of the Interim Rule with Request for Comment published April
23, 2007, at 72 FR 20039.
Regulatory Flexibility Act and Small Business Concerns
The Acting Administrator hereby certifies that this rulemaking has
been drafted in accordance with the Regulatory Flexibility Act (5
U.S.C. 605(b)).
Some of the firms DEA identified as potentially handling NPP are
small entities. The highest cost that the rule would impose on these
firms is less than $2,500 for registration. The smallest firm (1 to 4
employees) in the organic chemical sector has annual revenues of about
$1.1 million. For those not already registered with DEA, the cost of
registration represents 0.2 percent of annual revenues, which does not
constitute a significant economic impact. DEA did not receive any
comments to its Interim Rule controlling NPP as a List I chemical.
Therefore, the Acting Administrator certifies that this rule will not
have a significant economic impact on a substantial number of small
entities.
Executive Order 12866
The Acting Administrator certifies that this rulemaking has been
drafted in accordance with the principles in Executive Order 12866
Section 1(b). It has been determined that this is ``not a significant
regulatory action.'' Therefore, this action has not been reviewed by
the Office of Management and Budget.
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.
Paperwork Reduction Act
With publication of the Interim Final Rule controlling NPP as a
List I chemical (72 FR 20039), persons handling NPP became subject to
CSA List I regulatory requirements. Any person who manufactures,
distributes, imports, or exports NPP must register with DEA. As
discussed in the Interim Rule, DEA has identified 14 domestic chemical
companies who would be required to register with DEA if they continued
to handle NPP. Persons wishing to register with DEA to handle List I
chemicals must do so using DEA Form 510, Application for Registration
under Domestic Chemical Diversion Control Act of 1993, and persons
wishing to renew their registration must do so using DEA Form 510a,
Renewal Application for Registration under Domestic Chemical Diversion
Control Act of 1993 [OMB control 1117-0031]. With publication
of the Interim Rule, DEA received approval from the Office of
Management and Budget to revise this information collection as
discussed above.
Persons importing, exporting, and conducting international
transactions involving NPP must comply with regulatory requirements
regarding the notification of DEA of pending transactions. As DEA had
no information on which to estimate how many of the 14 identified firms
import, export, or conduct international transactions with NPP, DEA
estimated that all identified firms conduct such transactions. DEA
estimated that each firm will conduct five import transactions and two
export transactions annually. DEA did not identify any firms serving as
United States brokers conducting international transactions involving
NPP. Therefore, DEA did not estimate any international transactions
involving NPP. Persons importing, exporting, and conducting
international transactions involving List I chemicals report those
transactions to DEA on DEA Form 486, Import/Export Declaration for List
I and List II chemicals [OMB control 1117-0023]. With
publication of the Interim Rule, DEA received approval from the Office
of Management and Budget to revise this information collection as
discussed above.
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 were 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
Congressional Review Act/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 1310
Drug traffic control, Exports, Imports, List I and List II
chemicals, Reporting and recordkeeping requirements.
Adoption as Final Rule
0
The Interim Rule amending part 1310 of Title 21, of the Code of Federal
Regulations, which published in the Federal Register on April 23, 2007
at 72 FR 20039, is hereby adopted as a Final Rule without change.
Dated: July 17, 2008.
Michele M. Leonhart,
Acting Administrator.
[FR Doc. E8-17034 Filed 7-24-08; 8:45 am]
BILLING CODE 4410-09-P
