Proposed Adjustments to the Aggregate Production Quotas for Schedule I and II Controlled Substances and Assessment of Annual Needs for the List I Chemicals Ephedrine, Pseudoephedrine, and Phenylpropanolamine for 2016, 47829-47834 [2016-17371]
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Federal Register / Vol. 81, No. 141 / Friday, July 22, 2016 / Notices
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Michigan, the State in which he seeks
registration. Because he does not meet
this prerequisite for obtaining a DEA
registration, I will deny his application
on this basis.
Material Falsification
Pursuant to section 304(a)(1), the
Attorney General is also authorized to
suspend or revoke a registration ‘‘upon
a finding that the registrant . . . has
materially falsified any application filed
pursuant to or required by this
subchapter.’’ 21 U.S.C. 824(a)(1). It is
well established that the various
grounds for revocation or suspension of
an existing registration that Congress
enumerated in section 304(a), 21 U.S.C.
824(a), are also properly considered in
deciding whether to grant or deny an
application under section 303. See The
Lawsons, Inc., 72 FR 74334, 74337
(2007); Anthony D. Funches, 64 FR
14267, 14268 (1999); Alan R.
Schankman, 63 FR 45260 (1998); Kuen
H. Chen, 58 FR 65401, 65402 (1993).
Thus, the allegation that Applicant
materially falsified his application is
properly considered in this proceeding.
See Samuel S. Jackson, 72 FR 23848,
23852 (2007). Moreover, just as
materially falsifying an application
provides a basis for revoking an existing
registration without proof of any other
misconduct, see 21 U.S.C. 824(a)(1), it
also provides an independent and
adequate ground for denying an
application. The Lawsons, 72 FR 74338;
cf. Bobby Watts, M.D., 58 FR 46995
(1993).
Here, the Government’s evidence
shows that upon being served with an
Order to Show Cause and Immediate
Suspension of Registration which
alleged that he had prescribed
controlled substances in violation of the
CSA, Applicant surrendered his
registration. GXs 3 & 4. Moreover, on the
Voluntary Surrender form, Applicant
acknowledged that he was doing so
‘‘[i]n view of my alleged failure to
comply with the Federal requirements
pertaining to controlled substances.’’ GX
4. Yet days later, Applicant applied for
a new registration and provided a ‘‘no’’
answer to the question: ‘‘[h]as the
applicant ever surrendered (for cause) or
had a federal controlled substance
registration revoked, suspended,
restricted or denied, or is any such
action pending?’’ GX 1, at 1, 3.
Applicant’s answer was false as he
had clearly surrendered his registration
for cause. His false answer was also
material as ‘‘it ‘ha[d] a natural tendency
to influence, or was capable of
influencing, the decision of’ the
decisionmaking body to which it was
addressed.’’ Kungys v. United States,
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485 U.S. 759, 770 (1988) (quoting
Weinstock v. United States, 231 F.2d
699, 701 (D.C. Cir. 1956)) (other citation
omitted); see also United States v. Wells,
519 U.S. 482, 489 (1997) (quoting
Kungys, 485 U.S. at 770). As the
Supreme Court has further explained,
‘‘it has never been the test of materiality
that the misrepresentation or
concealment would more likely than not
have produced an erroneous decision,
or even that it would more likely than
not have triggered an investigation, but
rather, whether the misrepresentation or
concealment was predictably capable of
affecting, i.e., had a natural tendency to
affect, the official decision.’’ Kungys,
485 U.S. at 771. While the evidence
must be ‘‘clear, unequivocal, and
convincing,’’ the ‘‘ultimate finding of
materiality turns on an interpretation of
the substantive law.’’ Id. at 772 (int.
quotations and citations omitted).
Applicant’s false answer to the
question of whether he had ever
surrendered his federal registration was
clearly ‘‘capable of affecting’’ the
decision of whether to grant his
application. As the evidence shows,
Applicant surrendered his registration
in response to allegations that he
violated the CSA and DEA regulations
by prescribing controlled substances
that were in schedules for which he
lacked authorization, as well as
allegations that he issued prescriptions
that lacked a legitimate medical
purpose. GX 3, at 2 (Sept. 24, 2012
Immediate Suspension Order) (citing 21
U.S.C. 822(b) and 841(a)(1); 21 CFR
1301.12(a) and 1306.04(a)). Notably,
under the public interest standard, the
Agency is required to consider both the
Applicant’s ‘‘experience in dispensing
. . . controlled substances’’ and his
‘‘[c]ompliance with applicable State,
Federal, or local laws relating to
controlled substances.’’ 21 U.S.C.
823(f)(2) & (4). See also Shannon L.
Gallentine, D.P.M., 76 FR 45864, 45866
(2011).
Thus, notwithstanding that the
Agency did not grant his application,
his false answer was still material as it
was capable of influencing the decision
as to whether to grant his application.
See United States v. Alemany Rivera,
781 F.2d 229, 234 (1st Cir. 1985) (‘‘It
makes no difference that a specific
falsification did not exert influence so
long as it had the capacity to do so.’’);
United States v. Norris, 749 F.2d 1116,
1121 (4th Cir. 1984) (‘‘There is no
requirement that the false statement
influence or effect the decision making
process of a department of the United
States Government.’’). Accordingly, I
conclude that Applicant materially
falsified his September 2012 application
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47829
for registration. This provides a further
reason to deny his pending application.
Order
Pursuant to the authority vested in me
by 21 U.S.C. 823(f) and 28 CFR 0.100(b),
I order that the application of Mikhayl
Soliman, M.D., for a DEA Certificate of
Registration as a practitioner, be, and it
hereby is, denied. This Order is effective
immediately.
Dated: July 15, 2016.
Chuck Rosenberg,
Acting Administrator.
[FR Doc. 2016–17394 Filed 7–21–16; 8:45 am]
BILLING CODE 4410–09–P
DEPARTMENT OF JUSTICE
Drug Enforcement Administration
[Docket No. DEA–420P]
Proposed Adjustments to the
Aggregate Production Quotas for
Schedule I and II Controlled
Substances and Assessment of
Annual Needs for the List I Chemicals
Ephedrine, Pseudoephedrine, and
Phenylpropanolamine for 2016
Drug Enforcement
Administration, Department of Justice.
ACTION: Notice with request for
comments.
AGENCY:
The Drug Enforcement
Administration (DEA) proposes to
adjust the 2016 aggregate production
quotas for several controlled substances
in schedules I and II of the Controlled
Substances Act and assessment of
annual needs for the list I chemicals
ephedrine, pseudoephedrine, and
phenylpropanolamine.
SUMMARY:
Interested persons may file
written comments on this notice in
accordance with 21 CFR 1303.13(c) and
1315.13(d). Electronic comments must
be submitted, and written comments
must be postmarked, on or before
August 22, 2016. Commenters should be
aware that the electronic Federal Docket
Management System will not accept
comments after 11:59 p.m. Eastern Time
on the last day of the comment period.
Based on comments received in
response to this notice, the
Administrator may hold a public
hearing on one or more issues raised. In
the event the Administrator decides in
his sole discretion to hold such a
hearing, the Administrator will publish
a notice of any such hearing in the
Federal Register. After consideration of
any comments or objections, or after a
hearing, if one is held, the
Administrator will publish in the
DATES:
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Federal Register / Vol. 81, No. 141 / Friday, July 22, 2016 / Notices
ehiers on DSK5VPTVN1PROD with NOTICES
Federal Register a final order
establishing the 2016 adjusted aggregate
production quotas for schedule I and II
controlled substances, and an
assessment of annual needs for the list
I chemicals ephedrine,
pseudoephedrine, and
phenylpropanolamine.
ADDRESSES: To ensure proper handling
of comments, please reference ‘‘Docket
No. DEA–420P’’ on all correspondence,
including any attachments. The Drug
Enforcement Administration encourages
that all comments be submitted
electronically through the Federal
eRulemaking Portal which provides the
ability to type short comments directly
into the comment field on the Web page
or attach a file for lengthier comments.
Please go to https://www.regulations.gov
and follow the online instructions at
that site for submitting comments. Upon
completion of your submission you will
receive a Comment Tracking Number for
your comment. Please be aware that
submitted comments are not
instantaneously available for public
view on Regulations.gov. If you have
received a Comment Tracking Number,
your comment has been successfully
submitted and there is no need to
resubmit the same comment. Paper
comments that duplicate electronic
submissions are not necessary and are
discouraged. Should you wish to mail a
paper comment in lieu of an electronic
comment, it should be sent via regular
or express mail to: Drug Enforcement
Administration, Attention: DEA Federal
Register Representative/ODW, 8701
Morrissette Drive, Springfield, Virginia
22152.
FOR FURTHER INFORMATION CONTACT:
Michael J. Lewis, Office of Diversion
Control, Drug Enforcement
Administration; Mailing Address: 8701
Morrissette Drive, Springfield, Virginia
22152, Telephone: (202) 598–6812.
SUPPLEMENTARY INFORMATION:
Posting of Public Comments
Please note that all comments
received in response to this docket are
considered part of the public record.
They will, unless reasonable cause is
given, be made available by the Drug
Enforcement Administration (DEA) for
public inspection online at https://
www.regulations.gov. Such information
includes personal identifying
information (such as your name,
address, etc.) voluntarily submitted by
the commenter.
The Freedom of Information Act
(FOIA) applies to all comments
received. If you want to submit personal
identifying information (such as your
name, address, etc.) as part of your
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15:19 Jul 21, 2016
Jkt 238001
comment, but do not want it to be made
publicly available, 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 made publicly
available 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 made
publicly available, 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.
Comments containing personal
identifying information or confidential
business information identified and
located as directed above will generally
be made available in redacted form. If a
comment contains so much confidential
business information or personal
identifying information that it cannot be
effectively redacted, all or part of that
comment may not be made publicly
available. Comments posted to https://
www.regulations.gov may include any
personal identifying information (such
as name, address, and phone number)
included in the text of your electronic
submission that is not identified as
directed above as confidential.
An electronic copy of this document
is available at https://
www.regulations.gov for easy reference.
Legal Authority and Background
Section 306 of the Controlled
Substances Act (CSA) (21 U.S.C. 826)
requires the Attorney General to
establish aggregate production quotas
for each basic class of controlled
substance listed in schedules I and II
and for the list I chemicals ephedrine,
pseudoephedrine, and
phenylpropanolamine. The Attorney
General has delegated this function to
the Administrator of the DEA pursuant
to 28 CFR 0.100.
The DEA established the 2016
aggregate production quotas for
substances in schedules I and II and the
assessment of annual needs for the list
I chemicals ephedrine,
pseudoephedrine, and
phenylpropanolamine on October 6,
2015 (80 FR 60400). That notice
stipulated that, in accordance with 21
CFR 1303.13 and 1315.13, all aggregate
production quotas and assessments of
annual need are subject to adjustment.
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Analysis for Proposed Adjusted 2016
Aggregate Production Quotas and
Assessment of Annual Needs
The DEA proposes to adjust the
established 2016 aggregate production
quotas and assessment of annual needs
for certain schedule I and II controlled
substances, and the list I chemicals
ephedrine, pseudoephedrine, and
phenylpropanolamine, to be
manufactured in the United States in
2016 to provide for the estimated
medical, scientific, research, and
industrial needs of the United States, for
lawful export requirements, and for the
establishment and maintenance of
reserve stocks. These quotas do not
include imports of controlled
substances for use in industrial
processes.
In determining the proposed
adjustment, the Acting Administrator
has taken into account the criteria in
accordance with 21 CFR 1303.13
(adjustment of aggregate production
quotas for controlled substances) and 21
CFR 1315.13 (adjustment of the
assessment of annual needs for
ephedrine, pseudoephedrine, and
phenylpropanolamine). The DEA
determined whether to propose an
adjustment of the aggregate production
quotas and assessment of annual needs
for 2016 by considering: (1) Changes in
the demand for that class or chemical,
changes in the national rate of net
disposal of the class or chemical, and
changes in the rate of net disposal of the
class or chemical by registrants holding
individual manufacturing quotas for the
class; (2) whether any increased demand
for that class or chemical, the national
and/or individual rates of net disposal
of that class or chemical are temporary,
short term, or long term; (3) whether any
increased demand for that class or
chemical can be met through existing
inventories, increased individual
manufacturing quotas, or increased
importation, without increasing the
aggregate production quota; (4) whether
any decreased demand for that class or
chemical will result in excessive
inventory accumulation by all persons
registered to handle that class or
chemical; and (5) other factors affecting
medical, scientific, research, and
industrial needs in the United States
and lawful export requirements, as the
Acting Administrator finds relevant.
These quotas do not include imports of
controlled substances for use in
industrial processes.
The Acting Administrator also
considered updated information
obtained from 2015 year-end
inventories, 2015 disposition data
submitted by quota applicants,
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Federal Register / Vol. 81, No. 141 / Friday, July 22, 2016 / Notices
estimates of the medical needs of the
United States, product development,
and other information made available to
the DEA after the initial aggregate
production quotas and assessment of
annual needs had been established.
Other factors the Acting Administrator
considered in calculating the aggregate
production quotas, but not the
assessment of annual needs, include
product development requirements of
both bulk and finished dosage form
manufacturers, and other pertinent
information. In determining the
proposed adjusted 2016 assessment of
annual needs, the DEA used the
calculation methodology previously
described in the 2010 and 2011
established assessment of annual needs
(74 FR 60294, Nov. 20, 2009, and 75 FR
79407, Dec. 20, 2010, respectively).
As described in the previously
published notice establishing the 2016
aggregate production quotas and
assessment of annual needs, the DEA
has specifically considered that
inventory allowances granted to
individual manufacturers, 21 CFR
1303.24, may not always result in the
availability of sufficient quantities to
maintain an adequate reserve stock
pursuant to 21 U.S.C. 826(a), as
intended. This would be concerning if
a natural disaster or other unforeseen
event resulted in substantial disruption
to the amount of controlled substances
available to provide for legitimate
public need. As such, the DEA has
included in all proposed adjusted
schedule II controlled substance
aggregate production quotas, and certain
proposed adjusted schedule I controlled
substance aggregate production quotas,
an additional 25% of the estimated
medical, scientific, and research needs
as part of the amount necessary to
ensure the establishment and
maintenance of reserve stocks. The
resulting adjusted established aggregate
production quotas will reflect these
included amounts. This action will not
affect the ability of manufacturers to
maintain inventory allowances as
specified by regulation. The DEA
expects that maintaining this reserve in
certain established aggregate production
quotas will mitigate adverse public
effects if an unforeseen event resulted in
substantial disruption to the amount of
controlled substances available to
provide for legitimate public need, as
determined by the DEA. The DEA does
not anticipate utilizing the reserve in
the absence of these circumstances.
The Acting Administrator, therefore,
proposes that the year 2016 aggregate
production quotas for the two
temporarily scheduled substances be
established, and to adjust the 2016
aggregate production quotas for certain
schedule I and II controlled substances
and assessment of annual needs for the
list I chemicals ephedrine,
pseudoephedrine, and
phenylpropanolamine, expressed in
grams of anhydrous acid or base, as
follows:
Established
2016
quotas
(g)
Basic class
Proposed
revised 2016
quotas
(g)
Temporarily Scheduled Substances
beta-Hydroxythiofentanyl ................................................................................................................................
Butyryl fentanyl ...............................................................................................................................................
N/A
N/A
30.
30.
15
10
45
45
15
45
25
45
45
45
2
45
45
45
45
45
45
45
30
30
30
30
30
25
no
no
no
no
no
no
no
no
no
no
no
no
no
no
no
no
no
no
no
no
no
no
no
no
30
25
no change.
no change.
30
15
no change.
no change.
25
25
25
no change.
no change.
no change.
ehiers on DSK5VPTVN1PROD with NOTICES
Schedule I
[1-(5-fluoropentyl)-1H-indazol-3-yl](naphthalen-1-yl)methanone (THJ–2201) ................................................
1-(1-Phenylcyclohexyl)pyrrolidine ...................................................................................................................
1-(5-Fluoropentyl)-3-(1-naphthoyl)indole (AM2201) .......................................................................................
1-(5-Fluoropentyl)-3-(2-iodobenzoyl)indole (AM694) ......................................................................................
1-[1-(2-Thienyl)cyclohexyl]piperidine ..............................................................................................................
1-[2-(4-Morpholinyl)ethyl]-3-(1-naphthoyl)indole (JWH–200) .........................................................................
1-Benzylpiperazine .........................................................................................................................................
1-Butyl-3-(1-naphthoyl)indole (JWH–073) ......................................................................................................
1-Cyclohexylethyl-3-(2-methoxyphenylacetyl)indole (SR–18 and RCS–8) ....................................................
1-Hexyl-3-(1-naphthoyl)indole (JWH–019) .....................................................................................................
1-Methyl-4-phenyl-4-propionoxypiperidine ......................................................................................................
1-Pentyl-3-(1-naphthoyl)indole (JWH–018 and AM678) ................................................................................
1-Pentyl-3-(2-chlorophenylacetyl)indole (JWH–203) ......................................................................................
1-Pentyl-3-(2-methoxyphenylacetyl)indole (JWH–250) ..................................................................................
1-Pentyl-3-(4-chloro-1-naphthoyl)indole (JWH–398) ......................................................................................
1-Pentyl-3-(4-methyl-1-naphthoyl)indole (JWH–122) .....................................................................................
1-Pentyl-3-[(4-methoxy)-benzoyl]indole (SR–19, RCS–4) ..............................................................................
1-Pentyl-3-[1-(4-methoxynaphthoyl)]indole (JWH–081) .................................................................................
2-(2,5-Dimethoxy-4-ethylphenyl)ethanamine (2C–E) .....................................................................................
2-(2,5-Dimethoxy-4-methylphenyl)ethanamine (2C–D) ..................................................................................
2-(2,5-Dimethoxy-4-nitro-phenyl)ethanamine (2C–N) ....................................................................................
2-(2,5-Dimethoxy-4-n-propylphenyl)ethanamine (2C–P) ................................................................................
2-(2,5-Dimethoxyphenyl)ethanamine (2C–H) .................................................................................................
2-(4-Bromo-2,5-dimethoxyphenyl)-N-(2-methoxybenzyl)ethanamine (25B–NBOMe; 2C–B–NBOMe; 25B;
Cimbi-36).
2-(4-Chloro-2,5-dimethoxyphenyl)ethanamine (2C–C) ...................................................................................
2-(4-Chloro-2,5-dimethoxyphenyl)-N-(2-methoxybenzyl)ethanamine (25C–NBOMe; 2C–C–NBOMe; 25C;
Cimbi-82).
2-(4-Iodo-2,5-dimethoxyphenyl)ethanamine (2C–I) ........................................................................................
2-(4-Iodo-2,5-dimethoxyphenyl)-N-(2-methoxybenzyl)ethanamine (25I–NBOMe; 2C–I–NBOMe; 25I;
Cimbi-5).
2,5-Dimethoxy-4-ethylamphetamine (DOET) .................................................................................................
2,5-Dimethoxy-4-n-propylthiophenethylamine ................................................................................................
2,5-Dimethoxyamphetamine ...........................................................................................................................
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change.
change.
change.
change.
change.
change.
change.
change.
change.
change.
change.
change.
change.
change.
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change.
change.
change.
change.
change.
change.
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change.
47832
Federal Register / Vol. 81, No. 141 / Friday, July 22, 2016 / Notices
Established
2016
quotas
(g)
ehiers on DSK5VPTVN1PROD with NOTICES
Basic class
Proposed
revised 2016
quotas
(g)
2-[4-(Ethylthio)-2,5-dimethoxyphenyl]ethanamine (2C–T–2) ..........................................................................
2-[4-(Isopropylthio)-2,5-dimethoxyphenyl]ethanamine (2C–T–4) ...................................................................
3,4,5-Trimethoxyamphetamine .......................................................................................................................
3,4-Methylenedioxyamphetamine (MDA) .......................................................................................................
3,4-Methylenedioxymethamphetamine (MDMA) ............................................................................................
3,4-Methylenedioxy-N-ethylamphetamine (MDEA) ........................................................................................
3,4-Methylenedioxy-N-methylcathinone (methylone) .....................................................................................
3,4-Methylenedioxypyrovalerone (MDPV) ......................................................................................................
3–FMC; 3-Fluoro-N-methylcathinone .............................................................................................................
3-Methylfentanyl ..............................................................................................................................................
3-Methylthiofentanyl ........................................................................................................................................
4-Bromo-2,5-dimethoxyamphetamine (DOB) .................................................................................................
4-Bromo-2,5-dimethoxyphenethylamine (2–CB) ............................................................................................
4–FMC; Flephedrone ......................................................................................................................................
4-Methoxyamphetamine .................................................................................................................................
4-Methyl-2,5-dimethoxyamphetamine (DOM) .................................................................................................
4-Methylaminorex ...........................................................................................................................................
4–MEC; 4-Methyl-N-ethylcathinone ................................................................................................................
4-Methyl-N-methylcathinone (mephedrone) ...................................................................................................
4-Methyl-a-pyrrolidinopropiophenone (4-MePPP) ..........................................................................................
5-(1,1-Dimethylheptyl)-2-[(1R,3S)-3-hydroxycyclohexyl]-phenol ....................................................................
5-(1,1-Dimethyloctyl)-2-[(1R,3S)-3-hydroxycyclohexyl]-phenol (cannabicyclohexanol or CP–47,497 C8homolog).
5-Fluoro-UR144, XLR11 .................................................................................................................................
5-Methoxy-3,4-methylenedioxyamphetamine .................................................................................................
5-Methoxy-N,N-diisopropyltryptamine .............................................................................................................
5-Methoxy-N,N-dimethyltryptamine ................................................................................................................
AB–PINACA ....................................................................................................................................................
Acetyl-alpha-methylfentanyl ............................................................................................................................
Acetyldihydrocodeine ......................................................................................................................................
Acetylmethadol ...............................................................................................................................................
AH–7921 .........................................................................................................................................................
Allylprodine .....................................................................................................................................................
alpha-Ethyltryptamine .....................................................................................................................................
alpha-Methylfentanyl .......................................................................................................................................
alpha-Methylthiofentanyl .................................................................................................................................
alpha-Methyltryptamine (AMT) .......................................................................................................................
alpha-Pyrrolidinobutiophenone (a-PBP) .........................................................................................................
alpha-Pyrrolidinopentiophenone (a-PVP) .......................................................................................................
Alphacetylmethadol .........................................................................................................................................
Alphameprodine ..............................................................................................................................................
Alphamethadol ................................................................................................................................................
Aminorex .........................................................................................................................................................
APINCA, AKB48 .............................................................................................................................................
Benzylmorphine ..............................................................................................................................................
beta-Hydroxy-3-methylfentanyl .......................................................................................................................
beta-Hydroxyfentanyl ......................................................................................................................................
Betacetylmethadol ..........................................................................................................................................
Betameprodine ................................................................................................................................................
Betamethadol ..................................................................................................................................................
Betaprodine .....................................................................................................................................................
Bufotenine .......................................................................................................................................................
Butylone ..........................................................................................................................................................
Cathinone ........................................................................................................................................................
Codeine methylbromide ..................................................................................................................................
Codeine-N-oxide .............................................................................................................................................
Desomorphine .................................................................................................................................................
Diethyltryptamine ............................................................................................................................................
Difenoxin .........................................................................................................................................................
Dihydromorphine .............................................................................................................................................
Dimethyltryptamine .........................................................................................................................................
Dipipanone ......................................................................................................................................................
Fenethylline .....................................................................................................................................................
gamma-Hydroxybutyric acid ...........................................................................................................................
Heroin .............................................................................................................................................................
Hydromorphinol ...............................................................................................................................................
Hydroxypethidine ............................................................................................................................................
Ibogaine ..........................................................................................................................................................
Lysergic acid diethylamide (LSD) ...................................................................................................................
Marihuana .......................................................................................................................................................
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22JYN1
30
30
25
55
50
40
50
35
25
2
2
25
25
25
150
25
25
25
45
25
68
53
no change.
no change.
no change.
no change.
no change.
no change.
no change.
no change.
no change.
no change.
no change.
no change.
no change.
no change.
no change.
no change.
no change.
no change.
no change.
no change.
50.
40.
25
25
25
25
15
2
2
2
N/A
2
25
2
2
25
25
25
2
2
2
25
25
2
2
2
2
2
4
2
3
25
70
5
305
25
25
11,000
3,000,000
35
5
5
70,250,000
50
2
2
5
40
658,000
no change.
no change.
no change.
no change.
no change.
no change.
no change.
no change.
30.
no change.
no change.
no change.
no change.
no change.
no change.
no change.
no change.
no change.
no change.
no change.
no change.
no change.
no change.
no change.
no change.
no change.
no change.
no change.
no change.
no change.
30.
no change.
no change.
no change.
no change.
no change.
2,000,000.
no change.
no change.
no change.
no change.
no change.
no change.
no change.
no change.
no change.
no change.
47833
Federal Register / Vol. 81, No. 141 / Friday, July 22, 2016 / Notices
Established
2016
quotas
(g)
Basic class
Proposed
revised 2016
quotas
(g)
Mescaline ........................................................................................................................................................
Methaqualone .................................................................................................................................................
Methcathinone ................................................................................................................................................
Methyldesorphine ............................................................................................................................................
Methyldihydromorphine ...................................................................................................................................
Morphine methylbromide ................................................................................................................................
Morphine methylsulfonate ...............................................................................................................................
Morphine-N-oxide ...........................................................................................................................................
N,N-Dimethylamphetamine .............................................................................................................................
N-(1-Amino-3,3-dimethyl-1-oxobutan-2-yl)-1-pentyl-1H-indazole-3-carboxamide (ADB–PINACA) ................
N-(1-Amino-3-methyl-1-oxobutan-2-yl)-1-(4-fluorobenzyl)-1H-indazole-3-carboxamide (AB–FUBINACA) ....
N-(1-Amino-3-methyl-1-oxobutan-2-yl)-1-(cyclohexylmethyl)-1H-indazole-3-carboxamide (AB–CHMINACA)
N-(1-phenethylpiperidin-4-yl)-N-phenylacetamide (acetyl fentanyl) ...............................................................
N-Ethyl-1-phenylcyclohexylamine ...................................................................................................................
N-Ethylamphetamine ......................................................................................................................................
N-Hydroxy-3,4-methylenedioxyamphetamine .................................................................................................
Naphyrone ......................................................................................................................................................
Noracymethadol ..............................................................................................................................................
Norlevorphanol ................................................................................................................................................
Normethadone ................................................................................................................................................
Normorphine ...................................................................................................................................................
Para-fluorofentanyl ..........................................................................................................................................
Parahexyl ........................................................................................................................................................
Pentedrone .....................................................................................................................................................
Pentylone ........................................................................................................................................................
Phenomorphan ...............................................................................................................................................
Pholcodine ......................................................................................................................................................
Psilocybin ........................................................................................................................................................
Psilocyn ...........................................................................................................................................................
Quinolin-8-yl 1-(5-fluoropentyl)-1H-indole-3-carboxylate (5-fluoro-PB–22; 5F–PB–22) .................................
Quinolin-8-yl 1-pentyl-1H-indole-3-carboxylate (PB–22; QUPIC) ..................................................................
Tetrahydrocannabinols ...................................................................................................................................
Thiofentanyl ....................................................................................................................................................
Tilidine .............................................................................................................................................................
Trimeperidine ..................................................................................................................................................
UR–144 ...........................................................................................................................................................
25
10
25
5
2
5
5
350
25
50
50
15
100
5
24
24
25
2
52
2
40
5
5
25
25
2
5
30
50
50
50
511,250
2
25
2
25
no change.
no change.
no change.
no change.
no change.
no change.
no change.
no change.
no change.
no change.
no change.
no change.
no change.
no change.
no change.
no change.
no change.
no change.
no change.
no change.
no change.
no change.
no change.
no change.
no change.
no change.
no change.
no change.
no change.
25.
25.
no change.
no change.
no change.
no change.
no change.
5
5
2,950,000
17,750
3
25,125
15,000,000
39,705,000
19
200,000
50,000,000
63,900,000
19
226,375
3
31,250
1,337,500
125,000
3
3
2,300,000
3
235,000
88,500,000
8,250,000
5
4
30
7,125
29,750,000
5,450,000
6
no change.
no change.
2,250,000.
no change.
no change.
no change.
no change.
45,000,000.
no change.
no change.
no change.
no change.
no change.
no change.
no change.
18,750.
no change.
no change.
5.
no change.
no change.
no change.
177,500.
86,000,000.
7,000,000.
no change.
no change.
33.
no change.
23,750,000.
4,632,500.
no change.
ehiers on DSK5VPTVN1PROD with NOTICES
Schedule II
1-Phenylcyclohexylamine ...............................................................................................................................
1-Piperidinocyclohexanecarbonitrile ...............................................................................................................
4-Anilino-N-phenethyl-4-piperidine (ANPP) ....................................................................................................
Alfentanil .........................................................................................................................................................
Alphaprodine ...................................................................................................................................................
Amobarbital .....................................................................................................................................................
Amphetamine (for conversion) .......................................................................................................................
Amphetamine (for sale) ..................................................................................................................................
Carfentanil .......................................................................................................................................................
Cocaine ...........................................................................................................................................................
Codeine (for conversion) ................................................................................................................................
Codeine (for sale) ...........................................................................................................................................
Dextropropoxyphene .......................................................................................................................................
Dihydrocodeine ...............................................................................................................................................
Dihydroetorphine .............................................................................................................................................
Diphenoxylate (for conversion) .......................................................................................................................
Diphenoxylate (for sale) ..................................................................................................................................
Ecgonine .........................................................................................................................................................
Ethylmorphine .................................................................................................................................................
Etorphine hydrochloride ..................................................................................................................................
Fentanyl ..........................................................................................................................................................
Glutethimide ....................................................................................................................................................
Hydrocodone (for conversion) ........................................................................................................................
Hydrocodone (for sale) ...................................................................................................................................
Hydromorphone ..............................................................................................................................................
Isomethadone .................................................................................................................................................
Levo-alphacetylmethadol (LAAM) ...................................................................................................................
Levomethorphan .............................................................................................................................................
Levorphanol ....................................................................................................................................................
Lisdexamfetamine ...........................................................................................................................................
Meperidine ......................................................................................................................................................
Meperidine Intermediate-A .............................................................................................................................
VerDate Sep<11>2014
15:19 Jul 21, 2016
Jkt 238001
PO 00000
Frm 00088
Fmt 4703
Sfmt 4703
E:\FR\FM\22JYN1.SGM
22JYN1
47834
Federal Register / Vol. 81, No. 141 / Friday, July 22, 2016 / Notices
Established
2016
quotas
(g)
Basic class
Proposed
revised 2016
quotas
(g)
Meperidine Intermediate-B .............................................................................................................................
Meperidine Intermediate-C .............................................................................................................................
Metazocine ......................................................................................................................................................
Methadone (for sale) ......................................................................................................................................
Methadone Intermediate .................................................................................................................................
Methamphetamine ..........................................................................................................................................
11
6
19
31,875,000
34,375,000
2,061,375
no
no
no
no
no
no
change.
change.
change.
change.
change.
change.
[1,250,000 grams of levo-desoxyephedrine for use in a non-controlled, non-prescription product; 750,000 grams for methamphetamine mostly for
conversion to a schedule III product; and 61,375 grams for methamphetamine (for sale)]
Methylphenidate ..............................................................................................................................................
Morphine (for conversion) ...............................................................................................................................
Morphine (for sale) .........................................................................................................................................
Nabilone ..........................................................................................................................................................
Noroxymorphone (for conversion) ..................................................................................................................
Noroxymorphone (for sale) .............................................................................................................................
Opium (powder) ..............................................................................................................................................
Opium (tincture) ..............................................................................................................................................
Oripavine .........................................................................................................................................................
Oxycodone (for conversion) ...........................................................................................................................
Oxycodone (for sale) ......................................................................................................................................
Oxymorphone (for conversion) .......................................................................................................................
Oxymorphone (for sale) ..................................................................................................................................
Pentobarbital ...................................................................................................................................................
Phenazocine ...................................................................................................................................................
Phencyclidine ..................................................................................................................................................
Phenmetrazine ................................................................................................................................................
Phenylacetone ................................................................................................................................................
Racemethorphan ............................................................................................................................................
Racemorphan .................................................................................................................................................
Remifentanil ....................................................................................................................................................
Secobarbital ....................................................................................................................................................
Sufentanil ........................................................................................................................................................
Tapentadol ......................................................................................................................................................
Thebaine .........................................................................................................................................................
96,750,000
91,250,000
62,500,000
18,750
17,500,000
1,475,000
112,500
687,500
30,000,000
6,250,000
139,150,000
29,000,000
7,750,000
38,125,000
6
50
3
50
3
3
3,750
215,003
6,255
25,500,000
125,000,000
84,375,000.
no change.
no change.
no change.
no change.
625,000.
no change.
375,000.
no change.
5,000,000.
no change.
25,000,000.
6,250,000.
no change.
no change.
no change.
no change.
no change.
5.
no change.
no change.
no change.
no change.
no change.
no change.
100,000
4,000,000
22,400,000
8,500,000
7,000
224,500,000
50,000.
no change.
15,000,000.
no change.
40.
200,000,000.
List I Chemicals
Ephedrine (for conversion) .............................................................................................................................
Ephedrine (for sale) ........................................................................................................................................
Phenylpropanolamine (for conversion) ...........................................................................................................
Phenylpropanolamine (for sale) ......................................................................................................................
Pseudoephedrine (for conversion) .................................................................................................................
Pseudoephedrine (for sale) ............................................................................................................................
The Acting Administrator further
proposes that aggregate production
quotas for all other schedule I and II
controlled substances included in 21
CFR 1308.11 and 1308.12 remain at
zero. In accordance with 21 CFR
1303.13 and 21 CFR 1315.13, upon
consideration of the relevant factors, the
Acting Administrator may adjust the
2016 aggregate production quotas and
assessment of annual needs as needed.
ehiers on DSK5VPTVN1PROD with NOTICES
Conclusion
Dated: July 14, 2016.
Chuck Rosenberg,
Acting Administrator.
[FR Doc. 2016–17371 Filed 7–21–16; 8:45 am]
BILLING CODE 4410–09–P
DEPARTMENT OF JUSTICE
After consideration of any comments
or objections, or after a hearing, if one
is held, the Acting Administrator will
issue and publish in the Federal
Register a final order establishing any
adjustment of 2016 aggregate production
quota for each basic class of controlled
substances in schedules I and II and
VerDate Sep<11>2014
established assessment of annual needs
for the list I chemicals ephedrine,
pseudoephedrine, and
phenylpropanolamine, 21 CFR
1303.13(c) and 1315.13(f).
15:19 Jul 21, 2016
Jkt 238001
Notice of Charter Renewal
Justice Department.
Notice of Charter Renewal of the
Executive Advisory Board of the
National Domestic Communications
Assistance Center.
AGENCY:
ACTION:
PO 00000
Frm 00089
Fmt 4703
Sfmt 4703
In accordance with the
provisions of the Federal Advisory
Committee Act, title 5, United States
Code, Appendix, and title 41 of the U.S.
Code of Federal Regulations, section
101–6.1015, notice is hereby given that
the Charter of the National Domestic
Communications Assistance Center
(NDCAC) Executive Advisory Board
(EAB) has been renewed. The Charter is
on file with the General Services
Administration. The Attorney General
determined that the NDCAC EAB is in
the public interest and is necessary in
connection with the performance of
duties of the United States Department
of Justice. These duties can best be
performed through the advice and
counsel of this group.
The purpose of the EAB is to provide
advice and recommendations to the
SUMMARY:
E:\FR\FM\22JYN1.SGM
22JYN1
]]>Agencies
[Federal Register Volume 81, Number 141 (Friday, July 22, 2016)]
[Notices]
[Pages 47829-47834]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2016-17371]
-----------------------------------------------------------------------
DEPARTMENT OF JUSTICE
Drug Enforcement Administration
[Docket No. DEA-420P]
Proposed Adjustments to the Aggregate Production Quotas for
Schedule I and II Controlled Substances and Assessment of Annual Needs
for the List I Chemicals Ephedrine, Pseudoephedrine, and
Phenylpropanolamine for 2016
AGENCY: Drug Enforcement Administration, Department of Justice.
ACTION: Notice with request for comments.
-----------------------------------------------------------------------
SUMMARY: The Drug Enforcement Administration (DEA) proposes to adjust
the 2016 aggregate production quotas for several controlled substances
in schedules I and II of the Controlled Substances Act and assessment
of annual needs for the list I chemicals ephedrine, pseudoephedrine,
and phenylpropanolamine.
DATES: Interested persons may file written comments on this notice in
accordance with 21 CFR 1303.13(c) and 1315.13(d). Electronic comments
must be submitted, and written comments must be postmarked, on or
before August 22, 2016. Commenters should be aware that the electronic
Federal Docket Management System will not accept comments after 11:59
p.m. Eastern Time on the last day of the comment period.
Based on comments received in response to this notice, the
Administrator may hold a public hearing on one or more issues raised.
In the event the Administrator decides in his sole discretion to hold
such a hearing, the Administrator will publish a notice of any such
hearing in the Federal Register. After consideration of any comments or
objections, or after a hearing, if one is held, the Administrator will
publish in the
[[Page 47830]]
Federal Register a final order establishing the 2016 adjusted aggregate
production quotas for schedule I and II controlled substances, and an
assessment of annual needs for the list I chemicals ephedrine,
pseudoephedrine, and phenylpropanolamine.
ADDRESSES: To ensure proper handling of comments, please reference
``Docket No. DEA-420P'' on all correspondence, including any
attachments. The Drug Enforcement Administration encourages that all
comments be submitted electronically through the Federal eRulemaking
Portal which provides the ability to type short comments directly into
the comment field on the Web page or attach a file for lengthier
comments. Please go to https://www.regulations.gov and follow the online
instructions at that site for submitting comments. Upon completion of
your submission you will receive a Comment Tracking Number for your
comment. Please be aware that submitted comments are not
instantaneously available for public view on Regulations.gov. If you
have received a Comment Tracking Number, your comment has been
successfully submitted and there is no need to resubmit the same
comment. Paper comments that duplicate electronic submissions are not
necessary and are discouraged. Should you wish to mail a paper comment
in lieu of an electronic comment, it should be sent via regular or
express mail to: Drug Enforcement Administration, Attention: DEA
Federal Register Representative/ODW, 8701 Morrissette Drive,
Springfield, Virginia 22152.
FOR FURTHER INFORMATION CONTACT: Michael J. Lewis, Office of Diversion
Control, Drug Enforcement Administration; Mailing Address: 8701
Morrissette Drive, Springfield, Virginia 22152, Telephone: (202) 598-
6812.
SUPPLEMENTARY INFORMATION:
Posting of Public Comments
Please note that all comments received in response to this docket
are considered part of the public record. They will, unless reasonable
cause is given, be made available by the Drug Enforcement
Administration (DEA) for public inspection online at https://www.regulations.gov. Such information includes personal identifying
information (such as your name, address, etc.) voluntarily submitted by
the commenter.
The Freedom of Information Act (FOIA) applies to all comments
received. 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 made publicly available, 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 made publicly available 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 made publicly available, 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.
Comments containing personal identifying information or
confidential business information identified and located as directed
above will generally be made available in redacted form. If a comment
contains so much confidential business information or personal
identifying information that it cannot be effectively redacted, all or
part of that comment may not be made publicly available. Comments
posted to https://www.regulations.gov may include any personal
identifying information (such as name, address, and phone number)
included in the text of your electronic submission that is not
identified as directed above as confidential.
An electronic copy of this document is available at https://www.regulations.gov for easy reference.
Legal Authority and Background
Section 306 of the Controlled Substances Act (CSA) (21 U.S.C. 826)
requires the Attorney General to establish aggregate production quotas
for each basic class of controlled substance listed in schedules I and
II and for the list I chemicals ephedrine, pseudoephedrine, and
phenylpropanolamine. The Attorney General has delegated this function
to the Administrator of the DEA pursuant to 28 CFR 0.100.
The DEA established the 2016 aggregate production quotas for
substances in schedules I and II and the assessment of annual needs for
the list I chemicals ephedrine, pseudoephedrine, and
phenylpropanolamine on October 6, 2015 (80 FR 60400). That notice
stipulated that, in accordance with 21 CFR 1303.13 and 1315.13, all
aggregate production quotas and assessments of annual need are subject
to adjustment.
Analysis for Proposed Adjusted 2016 Aggregate Production Quotas and
Assessment of Annual Needs
The DEA proposes to adjust the established 2016 aggregate
production quotas and assessment of annual needs for certain schedule I
and II controlled substances, and the list I chemicals ephedrine,
pseudoephedrine, and phenylpropanolamine, to be manufactured in the
United States in 2016 to provide for the estimated medical, scientific,
research, and industrial needs of the United States, for lawful export
requirements, and for the establishment and maintenance of reserve
stocks. These quotas do not include imports of controlled substances
for use in industrial processes.
In determining the proposed adjustment, the Acting Administrator
has taken into account the criteria in accordance with 21 CFR 1303.13
(adjustment of aggregate production quotas for controlled substances)
and 21 CFR 1315.13 (adjustment of the assessment of annual needs for
ephedrine, pseudoephedrine, and phenylpropanolamine). The DEA
determined whether to propose an adjustment of the aggregate production
quotas and assessment of annual needs for 2016 by considering: (1)
Changes in the demand for that class or chemical, changes in the
national rate of net disposal of the class or chemical, and changes in
the rate of net disposal of the class or chemical by registrants
holding individual manufacturing quotas for the class; (2) whether any
increased demand for that class or chemical, the national and/or
individual rates of net disposal of that class or chemical are
temporary, short term, or long term; (3) whether any increased demand
for that class or chemical can be met through existing inventories,
increased individual manufacturing quotas, or increased importation,
without increasing the aggregate production quota; (4) whether any
decreased demand for that class or chemical will result in excessive
inventory accumulation by all persons registered to handle that class
or chemical; and (5) other factors affecting medical, scientific,
research, and industrial needs in the United States and lawful export
requirements, as the Acting Administrator finds relevant. These quotas
do not include imports of controlled substances for use in industrial
processes.
The Acting Administrator also considered updated information
obtained from 2015 year-end inventories, 2015 disposition data
submitted by quota applicants,
[[Page 47831]]
estimates of the medical needs of the United States, product
development, and other information made available to the DEA after the
initial aggregate production quotas and assessment of annual needs had
been established. Other factors the Acting Administrator considered in
calculating the aggregate production quotas, but not the assessment of
annual needs, include product development requirements of both bulk and
finished dosage form manufacturers, and other pertinent information. In
determining the proposed adjusted 2016 assessment of annual needs, the
DEA used the calculation methodology previously described in the 2010
and 2011 established assessment of annual needs (74 FR 60294, Nov. 20,
2009, and 75 FR 79407, Dec. 20, 2010, respectively).
As described in the previously published notice establishing the
2016 aggregate production quotas and assessment of annual needs, the
DEA has specifically considered that inventory allowances granted to
individual manufacturers, 21 CFR 1303.24, may not always result in the
availability of sufficient quantities to maintain an adequate reserve
stock pursuant to 21 U.S.C. 826(a), as intended. This would be
concerning if a natural disaster or other unforeseen event resulted in
substantial disruption to the amount of controlled substances available
to provide for legitimate public need. As such, the DEA has included in
all proposed adjusted schedule II controlled substance aggregate
production quotas, and certain proposed adjusted schedule I controlled
substance aggregate production quotas, an additional 25% of the
estimated medical, scientific, and research needs as part of the amount
necessary to ensure the establishment and maintenance of reserve
stocks. The resulting adjusted established aggregate production quotas
will reflect these included amounts. This action will not affect the
ability of manufacturers to maintain inventory allowances as specified
by regulation. The DEA expects that maintaining this reserve in certain
established aggregate production quotas will mitigate adverse public
effects if an unforeseen event resulted in substantial disruption to
the amount of controlled substances available to provide for legitimate
public need, as determined by the DEA. The DEA does not anticipate
utilizing the reserve in the absence of these circumstances.
The Acting Administrator, therefore, proposes that the year 2016
aggregate production quotas for the two temporarily scheduled
substances be established, and to adjust the 2016 aggregate production
quotas for certain schedule I and II controlled substances and
assessment of annual needs for the list I chemicals ephedrine,
pseudoephedrine, and phenylpropanolamine, expressed in grams of
anhydrous acid or base, as follows:
------------------------------------------------------------------------
Established 2016 Proposed revised
quotas 2016 quotas
Basic class -----------------------------------------
(g) (g)
------------------------------------------------------------------------
Temporarily Scheduled Substances
------------------------------------------------------------------------
beta-Hydroxythiofentanyl...... N/A 30.
Butyryl fentanyl.............. N/A 30.
------------------------------------------------------------------------
Schedule I
------------------------------------------------------------------------
[1-(5-fluoropentyl)-1H-indazol- 15 no change.
3-yl](naphthalen-1-
yl)methanone (THJ-2201).
1-(1- 10 no change.
Phenylcyclohexyl)pyrrolidine.
1-(5-Fluoropentyl)-3-(1- 45 no change.
naphthoyl)indole (AM2201).
1-(5-Fluoropentyl)-3-(2- 45 no change.
iodobenzoyl)indole (AM694).
1-[1-(2- 15 no change.
Thienyl)cyclohexyl]piperidine.
1-[2-(4-Morpholinyl)ethyl]-3- 45 no change.
(1-naphthoyl)indole (JWH-200).
1-Benzylpiperazine............ 25 no change.
1-Butyl-3-(1-naphthoyl)indole 45 no change.
(JWH-073).
1-Cyclohexylethyl-3-(2- 45 no change.
methoxyphenylacetyl)indole
(SR-18 and RCS-8).
1-Hexyl-3-(1-naphthoyl)indole 45 no change.
(JWH-019).
1-Methyl-4-phenyl-4- 2 no change.
propionoxypiperidine.
1-Pentyl-3-(1-naphthoyl)indole 45 no change.
(JWH-018 and AM678).
1-Pentyl-3-(2- 45 no change.
chlorophenylacetyl)indole
(JWH-203).
1-Pentyl-3-(2- 45 no change.
methoxyphenylacetyl)indole
(JWH-250).
1-Pentyl-3-(4-chloro-1- 45 no change.
naphthoyl)indole (JWH-398).
1-Pentyl-3-(4-methyl-1- 45 no change.
naphthoyl)indole (JWH-122).
1-Pentyl-3-[(4-methoxy)- 45 no change.
benzoyl]indole (SR-19, RCS-4).
1-Pentyl-3-[1-(4- 45 no change.
methoxynaphthoyl)]indole (JWH-
081).
2-(2,5-Dimethoxy-4- 30 no change.
ethylphenyl)ethanamine (2C-E).
2-(2,5-Dimethoxy-4- 30 no change.
methylphenyl)ethanamine (2C-
D).
2-(2,5-Dimethoxy-4-nitro- 30 no change.
phenyl)ethanamine (2C-N).
2-(2,5-Dimethoxy-4-n- 30 no change.
propylphenyl)ethanamine (2C-
P).
2-(2,5- 30 no change.
Dimethoxyphenyl)ethanamine
(2C-H).
2-(4-Bromo-2,5- 25 no change.
dimethoxyphenyl)-N-(2-
methoxybenzyl)ethanamine (25B-
NBOMe; 2C-B-NBOMe; 25B; Cimbi-
36).
2-(4-Chloro-2,5- 30 no change.
dimethoxyphenyl)ethanamine
(2C-C).
2-(4-Chloro-2,5- 25 no change.
dimethoxyphenyl)-N-(2-
methoxybenzyl)ethanamine (25C-
NBOMe; 2C-C-NBOMe; 25C; Cimbi-
82).
2-(4-Iodo-2,5- 30 no change.
dimethoxyphenyl)ethanamine
(2C-I).
2-(4-Iodo-2,5-dimethoxyphenyl)- 15 no change.
N-(2-methoxybenzyl)ethanamine
(25I-NBOMe; 2C-I-NBOMe; 25I;
Cimbi-5).
2,5-Dimethoxy-4- 25 no change.
ethylamphetamine (DOET).
2,5-Dimethoxy-4-n- 25 no change.
propylthiophenethylamine.
2,5-Dimethoxyamphetamine...... 25 no change.
[[Page 47832]]
2-[4-(Ethylthio)-2,5- 30 no change.
dimethoxyphenyl]ethanamine
(2C-T-2).
2-[4-(Isopropylthio)-2,5- 30 no change.
dimethoxyphenyl]ethanamine
(2C-T-4).
3,4,5-Trimethoxyamphetamine... 25 no change.
3,4-Methylenedioxyamphetamine 55 no change.
(MDA).
3,4- 50 no change.
Methylenedioxymethamphetamine
(MDMA).
3,4-Methylenedioxy-N- 40 no change.
ethylamphetamine (MDEA).
3,4-Methylenedioxy-N- 50 no change.
methylcathinone (methylone).
3,4-Methylenedioxypyrovalerone 35 no change.
(MDPV).
3-FMC; 3-Fluoro-N- 25 no change.
methylcathinone.
3-Methylfentanyl.............. 2 no change.
3-Methylthiofentanyl.......... 2 no change.
4-Bromo-2,5- 25 no change.
dimethoxyamphetamine (DOB).
4-Bromo-2,5- 25 no change.
dimethoxyphenethylamine (2-
CB).
4-FMC; Flephedrone............ 25 no change.
4-Methoxyamphetamine.......... 150 no change.
4-Methyl-2,5- 25 no change.
dimethoxyamphetamine (DOM).
4-Methylaminorex.............. 25 no change.
4-MEC; 4-Methyl-N- 25 no change.
ethylcathinone.
4-Methyl-N-methylcathinone 45 no change.
(mephedrone).
4-Methyl-[alpha]- 25 no change.
pyrrolidinopropiophenone (4-
MePPP).
5-(1,1-Dimethylheptyl)-2- 68 50.
[(1R,3S)-3-hydroxycyclohexyl]-
phenol.
5-(1,1-Dimethyloctyl)-2- 53 40.
[(1R,3S)-3-hydroxycyclohexyl]-
phenol (cannabicyclohexanol
or CP-47,497 C8-homolog).
5-Fluoro-UR144, XLR11......... 25 no change.
5-Methoxy-3,4- 25 no change.
methylenedioxyamphetamine.
5-Methoxy-N,N- 25 no change.
diisopropyltryptamine.
5-Methoxy-N,N- 25 no change.
dimethyltryptamine.
AB-PINACA..................... 15 no change.
Acetyl-alpha-methylfentanyl... 2 no change.
Acetyldihydrocodeine.......... 2 no change.
Acetylmethadol................ 2 no change.
AH-7921....................... N/A 30.
Allylprodine.................. 2 no change.
alpha-Ethyltryptamine......... 25 no change.
alpha-Methylfentanyl.......... 2 no change.
alpha-Methylthiofentanyl...... 2 no change.
alpha-Methyltryptamine (AMT).. 25 no change.
alpha-Pyrrolidinobutiophenone 25 no change.
([alpha]-PBP).
alpha-Pyrrolidinopentiophenone 25 no change.
([alpha]-PVP).
Alphacetylmethadol............ 2 no change.
Alphameprodine................ 2 no change.
Alphamethadol................. 2 no change.
Aminorex...................... 25 no change.
APINCA, AKB48................. 25 no change.
Benzylmorphine................ 2 no change.
beta-Hydroxy-3-methylfentanyl. 2 no change.
beta-Hydroxyfentanyl.......... 2 no change.
Betacetylmethadol............. 2 no change.
Betameprodine................. 2 no change.
Betamethadol.................. 4 no change.
Betaprodine................... 2 no change.
Bufotenine.................... 3 no change.
Butylone...................... 25 no change.
Cathinone..................... 70 30.
Codeine methylbromide......... 5 no change.
Codeine-N-oxide............... 305 no change.
Desomorphine.................. 25 no change.
Diethyltryptamine............. 25 no change.
Difenoxin..................... 11,000 no change.
Dihydromorphine............... 3,000,000 2,000,000.
Dimethyltryptamine............ 35 no change.
Dipipanone.................... 5 no change.
Fenethylline.................. 5 no change.
gamma-Hydroxybutyric acid..... 70,250,000 no change.
Heroin........................ 50 no change.
Hydromorphinol................ 2 no change.
Hydroxypethidine.............. 2 no change.
Ibogaine...................... 5 no change.
Lysergic acid diethylamide 40 no change.
(LSD).
Marihuana..................... 658,000 no change.
[[Page 47833]]
Mescaline..................... 25 no change.
Methaqualone.................. 10 no change.
Methcathinone................. 25 no change.
Methyldesorphine.............. 5 no change.
Methyldihydromorphine......... 2 no change.
Morphine methylbromide........ 5 no change.
Morphine methylsulfonate...... 5 no change.
Morphine-N-oxide.............. 350 no change.
N,N-Dimethylamphetamine....... 25 no change.
N-(1-Amino-3,3-dimethyl-1- 50 no change.
oxobutan-2-yl)-1-pentyl-1H-
indazole-3-carboxamide (ADB-
PINACA).
N-(1-Amino-3-methyl-1-oxobutan- 50 no change.
2-yl)-1-(4-fluorobenzyl)-1H-
indazole-3-carboxamide (AB-
FUBINACA).
N-(1-Amino-3-methyl-1-oxobutan- 15 no change.
2-yl)-1-(cyclohexylmethyl)-1H-
indazole-3-carboxamide (AB-
CHMINACA).
N-(1-phenethylpiperidin-4-yl)- 100 no change.
N-phenylacetamide (acetyl
fentanyl).
N-Ethyl-1- 5 no change.
phenylcyclohexylamine.
N-Ethylamphetamine............ 24 no change.
N-Hydroxy-3,4- 24 no change.
methylenedioxyamphetamine.
Naphyrone..................... 25 no change.
Noracymethadol................ 2 no change.
Norlevorphanol................ 52 no change.
Normethadone.................. 2 no change.
Normorphine................... 40 no change.
Para-fluorofentanyl........... 5 no change.
Parahexyl..................... 5 no change.
Pentedrone.................... 25 no change.
Pentylone..................... 25 no change.
Phenomorphan.................. 2 no change.
Pholcodine.................... 5 no change.
Psilocybin.................... 30 no change.
Psilocyn...................... 50 no change.
Quinolin-8-yl 1-(5- 50 25.
fluoropentyl)-1H-indole-3-
carboxylate (5-fluoro-PB-22;
5F-PB-22).
Quinolin-8-yl 1-pentyl-1H- 50 25.
indole-3-carboxylate (PB-22;
QUPIC).
Tetrahydrocannabinols......... 511,250 no change.
Thiofentanyl.................. 2 no change.
Tilidine...................... 25 no change.
Trimeperidine................. 2 no change.
UR-144........................ 25 no change.
------------------------------------------------------------------------
Schedule II
------------------------------------------------------------------------
1-Phenylcyclohexylamine....... 5 no change.
1- 5 no change.
Piperidinocyclohexanecarbonit
rile.
4-Anilino-N-phenethyl-4- 2,950,000 2,250,000.
piperidine (ANPP).
Alfentanil.................... 17,750 no change.
Alphaprodine.................. 3 no change.
Amobarbital................... 25,125 no change.
Amphetamine (for conversion).. 15,000,000 no change.
Amphetamine (for sale)........ 39,705,000 45,000,000.
Carfentanil................... 19 no change.
Cocaine....................... 200,000 no change.
Codeine (for conversion)...... 50,000,000 no change.
Codeine (for sale)............ 63,900,000 no change.
Dextropropoxyphene............ 19 no change.
Dihydrocodeine................ 226,375 no change.
Dihydroetorphine.............. 3 no change.
Diphenoxylate (for conversion) 31,250 18,750.
Diphenoxylate (for sale)...... 1,337,500 no change.
Ecgonine...................... 125,000 no change.
Ethylmorphine................. 3 5.
Etorphine hydrochloride....... 3 no change.
Fentanyl...................... 2,300,000 no change.
Glutethimide.................. 3 no change.
Hydrocodone (for conversion).. 235,000 177,500.
Hydrocodone (for sale)........ 88,500,000 86,000,000.
Hydromorphone................. 8,250,000 7,000,000.
Isomethadone.................. 5 no change.
Levo-alphacetylmethadol (LAAM) 4 no change.
Levomethorphan................ 30 33.
Levorphanol................... 7,125 no change.
Lisdexamfetamine.............. 29,750,000 23,750,000.
Meperidine.................... 5,450,000 4,632,500.
Meperidine Intermediate-A..... 6 no change.
[[Page 47834]]
Meperidine Intermediate-B..... 11 no change.
Meperidine Intermediate-C..... 6 no change.
Metazocine.................... 19 no change.
Methadone (for sale).......... 31,875,000 no change.
Methadone Intermediate........ 34,375,000 no change.
Methamphetamine............... 2,061,375 no change.
------------------------------------------------------------------------
[1,250,000 grams of levo-desoxyephedrine for use in a non-controlled,
non-prescription product; 750,000 grams for methamphetamine mostly for
conversion to a schedule III product; and 61,375 grams for
methamphetamine (for sale)]
------------------------------------------------------------------------
Methylphenidate............... 96,750,000 84,375,000.
Morphine (for conversion)..... 91,250,000 no change.
Morphine (for sale)........... 62,500,000 no change.
Nabilone...................... 18,750 no change.
Noroxymorphone (for 17,500,000 no change.
conversion).
Noroxymorphone (for sale)..... 1,475,000 625,000.
Opium (powder)................ 112,500 no change.
Opium (tincture).............. 687,500 375,000.
Oripavine..................... 30,000,000 no change.
Oxycodone (for conversion).... 6,250,000 5,000,000.
Oxycodone (for sale).......... 139,150,000 no change.
Oxymorphone (for conversion).. 29,000,000 25,000,000.
Oxymorphone (for sale)........ 7,750,000 6,250,000.
Pentobarbital................. 38,125,000 no change.
Phenazocine................... 6 no change.
Phencyclidine................. 50 no change.
Phenmetrazine................. 3 no change.
Phenylacetone................. 50 no change.
Racemethorphan................ 3 5.
Racemorphan................... 3 no change.
Remifentanil.................. 3,750 no change.
Secobarbital.................. 215,003 no change.
Sufentanil.................... 6,255 no change.
Tapentadol.................... 25,500,000 no change.
Thebaine...................... 125,000,000 no change.
------------------------------------------------------------------------
List I Chemicals
------------------------------------------------------------------------
Ephedrine (for conversion).... 100,000 50,000.
Ephedrine (for sale).......... 4,000,000 no change.
Phenylpropanolamine (for 22,400,000 15,000,000.
conversion).
Phenylpropanolamine (for sale) 8,500,000 no change.
Pseudoephedrine (for 7,000 40.
conversion).
Pseudoephedrine (for sale).... 224,500,000 200,000,000.
------------------------------------------------------------------------
The Acting Administrator further proposes that aggregate production
quotas for all other schedule I and II controlled substances included
in 21 CFR 1308.11 and 1308.12 remain at zero. In accordance with 21 CFR
1303.13 and 21 CFR 1315.13, upon consideration of the relevant factors,
the Acting Administrator may adjust the 2016 aggregate production
quotas and assessment of annual needs as needed.
Conclusion
After consideration of any comments or objections, or after a
hearing, if one is held, the Acting Administrator will issue and
publish in the Federal Register a final order establishing any
adjustment of 2016 aggregate production quota for each basic class of
controlled substances in schedules I and II and established assessment
of annual needs for the list I chemicals ephedrine, pseudoephedrine,
and phenylpropanolamine, 21 CFR 1303.13(c) and 1315.13(f).
Dated: July 14, 2016.
Chuck Rosenberg,
Acting Administrator.
[FR Doc. 2016-17371 Filed 7-21-16; 8:45 am]
BILLING CODE 4410-09-P
