[Federal Register Volume 84, Number 159 (Friday, August 16, 2019)]
[Rules and Regulations]
[Pages 41913-41914]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2019-17623]
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DEPARTMENT OF JUSTICE
Drug Enforcement Administration
21 CFR Part 1308
[Docket No. DEA-332]
Listing of Noroxymorphone in the Code of Federal Regulations and
Assignment of a Controlled Substances Code Number
AGENCY: Drug Enforcement Administration, Department of Justice.
ACTION: Final rule.
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SUMMARY: Noroxymorphone is a derivative of opium and opiates and, as
such, is a schedule II controlled substance. The Drug Enforcement
Administration (DEA) has established the use of the Drug Enforcement
Administration Code Number 9668 for tracking noroxymorphone and for
establishing aggregate production quotas. This rule amends the Code of
Federal Regulations (CFR) to reflect the current practice of using the
Code Number 9668 for noroxymorphone. This rulemaking will list the
schedule II controlled substance noroxymorphone as a basic class with
the Code Number 9668. This rule does not affect the control of
noroxymorphone as a schedule II controlled substance.
DATES: Effective: August 16, 2019.
FOR FURTHER INFORMATION CONTACT: Lynnette Wingert, Diversion Control
Division, Drug Enforcement Administration; Mailing Address: 8701
Morrissette Drive, Springfield, Virginia 22152; Telephone (202) 598-
8837.
SUPPLEMENTARY INFORMATION: Noroxymorphone is a schedule II controlled
substance defined in the Controlled Substances Act (CSA) by 21 U.S.C.
812(c), Schedule II (a)(1) and 21 CFR 1308.12(b)(1), which control
``opium and opiate, and any salt, compound, derivative, or preparation
of opium or opiate.'' It meets the statutory definition of a ``narcotic
drug'' as stated in 21 U.S.C. 802(17) as it can be obtained from the
chemical modification of substances extracted from vegetable origin,
specifically from the plant species Papaver somniferum L. that is
lawfully defined as ``opium poppy'' by 21 U.S.C. 802(19). It is not an
isoquinoline alkaloid, which is categorically excluded from the
statutory definition of a ``narcotic drug.'' 21 U.S.C. 802(17)(A).
Rather, noroxymorphone is a phenanthrene alkaloid with a similar
chemical structure to other opium and opiate phenanthrene alkaloids
listed in 21 CFR 1308.12(b)(1), such as hydrocodone, hydromorphone,
dihydroetorphine, ethylmorphine, etorphine hydrochloride, metopon,
thebaine, morphine, codeine, oxycodone, and oxymorphone. Noroxymorphone
meets the statutory definition of ``opiate'' as it can be readily
converted to other morphine-like substances including oxymorphone,
which has an addiction-forming or addiction-sustaining abuse liability
similar to morphine. Based on the similarity of the chemical structure
of noroxymorphone to opium alkaloids listed in 21 CFR 1308.12(b)(1),
and the fact that it is obtained by the chemical modification of these
listed opium alkaloids, noroxymorphone is a derivative of opium and
opiates and a schedule II controlled substance as defined by 21 U.S.C.
812(a)(1) Schedule II and 21 CFR 1308.12(b)(1).
As provided in 21 CFR 1308.03, each controlled substance or basic
class thereof is assigned a four digit Drug Enforcement Administration
Controlled Substances Code Number that is used to track quantities of
the controlled substance imported and exported to and from the United
States. Additionally, DEA uses these Code Numbers in establishing
aggregate production quotas for basic classes of controlled substances
listed in schedules I and II as required by 21 U.S.C. 826.
Since 1996, DEA has established an aggregate production quota for
noroxymorphone using the DEA Controlled Substances Code Number 9668. In
this final rule, DEA is amending the CFR to reflect the current
practice of using the DEA Controlled Substances Code Number 9668 for
noroxymorphone. Listing noroxymorphone and its DEA Controlled
Substances Code Number in 21 CFR 1308.12(b)(1) does not alter the
status of noroxymorphone as a Schedule II controlled substance.
Noroxymorphone already is included as a Schedule II controlled
substance because 21 CFR 1308.12(b)(1) controls any salt, compound,
derivative, or preparation of the listed substances. Accordingly,
noroxymorphone has been controlled as a derivative of the listed
substances and this rule will not result in adding any new substances
into the schedules. Listing noroxymorphone also will not affect the
aggregate production quota currently established. DEA-registered
manufacturers of noroxymorphone previously granted individual quotas
for such purposes may continue to apply for quota after this rule is
finalized.
Regulatory Analyses
Administrative Procedure Act (APA)
Under 5 U.S.C. 553(b)(3)(B), an agency may dispense with notice and
comment rulemaking when, for good cause, it ``finds . . . that notice
and public procedure thereon are impracticable, unnecessary, or
contrary to the public interest.'' DEA finds that notice and comment
rulemaking is unnecessary and that good cause exists to dispense with
these procedures because the inclusion of noroxymorphone and its DEA
Controlled Substances Code Number in the list of schedule II substances
in 21 CFR 1308.12(b)(1) is `` `a minor or merely technical amendment in
which the public is not particularly interested.' '' National
Nutritional Foods Ass'n v. Kennedy, 572 F.2d 377, 385 (2d Cir. 1978)
(quoting S. Rep. No. 79-752, at 200 (1945)). See also Utility Solid
Waste Activities Group v. E.P.A., 236 F.3d 749, 755 (D.C. Cir. 2001)
(the ``unnecessary'' prong ``is confined to those situations in which
the administrative rule is a routine determination, insignificant in
nature and impact, and inconsequential to the industry and public'')
(int. quotations and citation omitted). This rule is a ``technical
amendment'' to 21 CFR 1308.12(b)(1) as it is ``insignificant in nature
and impact, and inconsequential to the industry and public.''
Similarly, the APA states that a rule cannot be made effective less
than 30 days after publication, unless the rule falls under one of
three enumerated exceptions. One of these exceptions is when an agency
provides good cause that compliance would be impracticable,
unnecessary, or contrary to the public interest. 5 U.S.C. 553(d)(3). A
delayed effective date for this rule is unnecessary because this rule
simply lists the schedule II controlled substance noroxymorphone in 21
CFR 1308.12(b)(1) as a basic class and assigns to it the DEA Controlled
Substances Code Number 9668. This rule merely amends the CFR to reflect
the current DEA business practice and better assist companies in
complying with registration and quota requirements. In addition, this
rule does not require those firms that handle
[[Page 41914]]
noroxymorphone to alter their current practices with respect to their
quota applications and reporting obligations.
For the reasons stated above, notice and comment procedures are
unnecessary and this rule may be made effective upon publication.
Executive Order 12866, 13563, and 13771, Regulatory Planning and
Review, Improving Regulation and Regulatory Review, and Reducing
Regulation and Controlling Regulatory Costs
This regulation has been drafted and reviewed in accordance with
the principles of Executive Orders 12866 and 13563. This rule is not a
significant regulatory action under Executive Order 12866.
Noroxymorphone is a derivative of opium and opiates and, as such, is a
schedule II controlled substance. In this final rule, DEA is merely
amending its regulations to reflect the current practice of using the
DEA Controlled Substances Code Number 9668 for noroxymorphone. Listing
noroxymorphone and its DEA Controlled Substances Code Number will not
alter the status of noroxymorphone as a Schedule II controlled
substance. Accordingly, this rule has not been reviewed by the Office
of Management and Budget.
Because this final rule is not significant under Executive Order
12866, it is not subject to the requirements of Executive Order
13771.\1\
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\1\ Office of Mgmt. & Budget, Exec. Office of The President,
Interim Guidance Implementing Section 2 of the Executive Order of
January 30, 2017 Titled ``Reducing Regulation and Controlling
Regulatory Costs'' (Feb. 2, 2017).
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Executive Order 12988, Civil Justice Reform
This regulation meets the applicable standards set forth in
sections 3(a) and 3(b)(2) of Executive Order 12988 to eliminate
drafting errors and ambiguity, minimize litigation, provide a clear
legal standard for affected conduct, and promote simplification and
burden reduction.
Executive Order 13132, Federalism
This rulemaking does not have federalism implications warranting
the application of Executive Order 13132. The rule does not have
substantial direct effects on the States, on the relationship between
the national government and the States, or the distribution of power
and responsibilities among the various levels of government.
Executive Order 13175, Consultation and Coordination With Indian Tribal
Governments
This rule does not have tribal implications warranting the
application of Executive Order 13175. It does not have substantial
direct effects on one or more Indian tribes, on the relationship
between the Federal Government and Indian tribes, or on the
distribution of power and responsibilities between the Federal
Government and Indian tribes.
Regulatory Flexibility Act
The Regulatory Flexibility Act (RFA) (5 U.S.C. 601-612) applies to
rules that are subject to notice and comment under section 553(b) of
the APA or other laws. As explained above, the DEA determined that
there was good cause to exempt this final rule from notice and comment.
Consequently, the RFA does not apply to this final rule.
Unfunded Mandates Reform Act of 1995
This final rule will not result in the expenditure by state, local,
and tribal governments, in the aggregate, or by the private sector, of
$100,000,000 or more (adjusted for inflation) in any one year, and will
not significantly or uniquely affect small governments. Therefore, no
actions were deemed under the provisions of the Unfunded Mandates
Reform Act of 1995, 2 U.S.C. 1532.
Paperwork Reduction Act of 1995
This rule does not impose a collection of information requirement
under the Paperwork Reduction Act of 1995. 44 U.S.C. 3501-3521.
Congressional Review Act
This rule is not a major rule as defined by section 804 of the
Congressional Review Act (CRA), 5 U.S.C. 804. Pursuant to the CRA, the
DEA is submitting a copy of this final rule to both Houses of Congress
and to the Comptroller General.
List of Subjects in 21 CFR Part 1308
Drug traffic control, Controlled Substances.
For the reasons set out above, 21 CFR part 1308 is amended as
follows:
PART 1308--SCHEDULES OF CONTROLLED SUBSTANCES
0
1. The authority citation for part 1308 continues to read as follows:
Authority: 21 U.S.C. 811, 812, 871(b), unless otherwise noted.
0
2. Section 1308.12 is amended by redesignating paragraphs (b)(1)(x)
through (xviii) as paragraphs (b)(1)(xi) through (xix), respectively,
and by adding a new paragraph (b)(1)(x) to read as follows:
Sec. 1308.12 Schedule II.
* * * * *
(b) * * *
(1) * * *
* * * * *
(x) Noroxymorphone............................................ 9668
* * * * *
Dated: August 5, 2019.
Uttam Dhillon,
Acting Administrator.
[FR Doc. 2019-17623 Filed 8-15-19; 8:45 am]
BILLING CODE 4410-09-P