[Federal Register Volume 83, Number 164 (Thursday, August 23, 2018)]
[Notices]
[Pages 42690-42696]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2018-18265]


=======================================================================
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DEPARTMENT OF JUSTICE

Drug Enforcement Administration

[Docket No. DEA-471P]


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 2018

AGENCY: Drug Enforcement Administration, Department of Justice.

ACTION: Notice with request for comments.

-----------------------------------------------------------------------

SUMMARY: The Drug Enforcement Administration (DEA) proposes to adjust 
the 2018 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 September 24, 2018. 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 Federal Register a final order establishing the 2018 
adjusted aggregate

[[Page 42691]]

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-471P'' 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 http://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/DRW, 8701 Morrissette Drive, 
Springfield, Virginia 22152.

FOR FURTHER INFORMATION CONTACT: Thomas D. Sonnen, Diversion Control 
Division, 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 http://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 http://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 http://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 2018 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 November 8, 2017 (82 FR 51873). 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 2018 Aggregate Production Quotas and 
Assessment of Annual Needs

    The DEA proposes to adjust the established 2018 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 2018 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 2018 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 2017 year-end inventories, 2017 disposition data 
submitted by quota applicants,

[[Page 42692]]

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 2018 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).
    The Acting Administrator, therefore, proposes to adjust the 2018 
aggregate production quotas for certain schedule I and II controlled 
substances and the assessment of annual needs for the list I chemicals 
ephedrine, pseudoephedrine, and phenylpropanolamine, expressed in grams 
of anhydrous acid or base, as follows:

------------------------------------------------------------------------
                                    Established
           Basic class              2018 quotas    Proposed revised 2018
                                        (g)             quotas (g)
------------------------------------------------------------------------
                    Temporarily Scheduled Substances
------------------------------------------------------------------------
1-(4-Cyanobutyl)-N-(2-                       N/A  25.
 phenylpropan-2-yl)-1H-indazole-
 3-carboximide.
1-(5-Fluoropentyl)-N-(2-                     N/A  25.
 phenylpropan-2-yl)-1H-
 pyrrolo[2,3-b]pyridine-
 3carboximide.
Cyclopropyl Fentanyl............             N/A  20.
Fentanyl related substances.....             N/A  25.
Isobutyryl Fentanyl.............             N/A  25.
Methyl-2-(1-(cyclohexylmethyl)-              N/A  25.
 1H-indole-3-carboxamido)-3-
 methylbutanoate.
N-(1-Amino-3-methyl-1-oxobutan-2-            N/A  25.
 yl)-1-(5-fluoropentyl)-1H-
 indazole-3-carboxamide.
Naphthalen-1-yl 1-(5-                        N/A  25.
 fluorpentyl)-1H-indole-3-
 carboxylate.
Ocfentanil......................             N/A  25.
Para-flourobutyryl fentanyl.....             N/A  25.
Tetrahydrofuranyl fentanyl......             N/A  5.
Valeryl fentanyl................             N/A  25.
------------------------------------------------------------------------
                               Schedule I
------------------------------------------------------------------------
1-[1-(2-                                    Zero  20.
 Thienyl)cyclohexyl]pyrrolidine.
1-(1-                                         10  15.
 Phenylcyclohexyl)pyrrolidine.
1-(2-Phenylethyl)-4-phenyl-4-               zero  10.
 acetoxypiperidine.
1-(5-Fluoropentyl)-3-(1-                      30  no change.
 naphthoyl)indole (AM2201).
1-(5-Fluoropentyl)-3-(2-                      30  no change.
 iodobenzoyl)indole (AM694).
1-[1-(2-                                      15  no change.
 Thienyl)cyclohexyl]piperidine.
1-Benzylpiperazine..............              25  no change.
1-Methyl-4-phenyl-4-                           2  10.
 propionoxypiperidine.
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-dimethoxyphenyl)-              30  no change.
 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-dimethoxyphenyl)-             25  no change.
 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)-N-             30  no change.
 (2-methoxybenzyl)ethanamine
 (25I-NBOMe; 2C-I-NBOMe; 25I;
 Cimbi-5).
2,5-Dimethoxy-4-ethylamphetamine              25  no change.
 (DOET).
2,5-Dimethoxy-4-n-                            25  no change.
 propylthiophenethylamine.
2,5-Dimethoxyamphetamine........              25  no change.
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.....              30  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-                         40  no change.
 methylcathinone (methylone).
3,4-Methylenedioxypyrovalerone                35  no change.
 (MDPV).
3-FMC; 3-Fluoro-N-                            25  no change.
 methylcathinone.
3-Methylfentanyl................              30  no change.
3-Methylthiofentanyl............              30  no change.
4-Bromo-2,5-dimethoxyamphetamine              30  no change.
 (DOB).
4-Bromo-2,5-                                  25  no change.
 dimethoxyphenethylamine (2-CB).
4-Fluoroisobutyryl fentanyl.....              30  no change.
4-FMC; Flephedrone..............              25  no change.
4-MEC; 4-Methyl-N-ethylcathinone              25  no change.
4-Methoxyamphetamine............             150  no change.
4-Methyl-2,5-                                 25  no change.
 dimethoxyamphetamine (DOM).
4-Methylaminorex................              25  no change.

[[Page 42693]]

 
4-Methyl-N-methylcathinone                    45  no change.
 (mephedrone).
4-Methyl-[alpha]-                             25  no change.
 pyrrolidinopropiophenone (4-
 MePPP).
5-(1,1-Dimethylheptyl)-2-                     50  no change.
 [(1R,3S)-3-hydroxycyclohexyl]-
 phenol.
5-(1,1-Dimethyloctyl)-2-[(1R,3S)-             40  no change.
 3-hydroxycyclohexyl]-phenol
 (cannabicyclohexanol or CP-
 47,497 C8-homolog).
5F-ADB; 5F-MDMB-PINACA (methyl 2-             30  no change.
 (1-(5-fluoropentyl)-1H-indazole-
 3-carboxamido)-3,3-
 dimethylbutanoate).
5F-AMB (methyl 2-(1-(5-                       30  no change.
 fluoropentyl)-1H-indazole-3-
 carboxamido)-3-methylbutanoate).
5F-APINACA; 5F-AKB48 (N-                      30  no change.
 (adamantan-1-yl)-1-(5-
 fluoropentyl)-1H-indazole-3-
 carboxamide).
5-Fluoro-PB-22; 5F-PB-22........              20  no change.
5-Fluoro-UR144, XLR11 ([1-(5-                 25  no change.
 fluoro-pentyl)-1Hindol-.
3-yl](2,2,3,3-
 tetramethylcyclopropyl)methanon
 e.
5-Methoxy-3,4-                                25  no change.
 methylenedioxyamphetamine.
5-Methoxy-N,N-                                25  no change.
 diisopropyltryptamine.
5-Methoxy-N,N-dimethyltryptamine              25  no change.
AB-CHMINACA.....................              30  no change.
AB-FUBINACA.....................              50  no change.
AB-PINACA.......................              30  no change.
ADB-FUBINACA (N-(1-amino-3,3-                 30  no change.
 dimethyl-1-oxobutan-2-yl)-1-(4-
 fluorobenzyl)-1H-indazole-3-
 carboxamide).
Acetyl Fentanyl.................             100  no change.
Acetyl-alpha-methylfentanyl.....              30  no change.
Acetyldihydrocodeine............              30  no change.
Acetylmethadol..................               2  no change.
Acryl Fentanyl..................              25  no change.
ADB-PINACA (N-(1-amino-3,3-                   50  no change.
 dimethyl-1-oxobutan-2-yl)-1-
 pentyl-1H-indazole-3-
 carboxamide).
AH-7921.........................              30  no change.
Allylprodine....................               2  no change.
Alphacetylmethadol..............               2  no change.
alpha-Ethyltryptamine...........              25  no change.
Alphameprodine..................               2  no change.
Alphamethadol...................               2  no change.
alpha-Methylfentanyl............              30  no change.
alpha-Methylthiofentanyl........              30  no change.
alpha-Methyltryptamine (AMT)....              25  no change.
alpha-Pyrrolidinobutiophenone                 25  no change.
 ([alpha]-PBP).
alpha-Pyrrolidinopentiophenone                25  no change.
 ([alpha]-PVP).
Aminorex........................              25  no change.
APINCA, AKB48 (N-(1-adamantyl)-1-             25  no change.
 pentyl-1H-indazole-3-
 carboxamide).
Benzylmorphine..................              30  no change.
Betacetylmethadol...............               2  no change.
beta-Hydroxy-3-methylfentanyl...              30  no change.
beta-Hydroxyfentanyl............              30  no change.
beta-Hydroxythiofentanyl........              30  no change.
Betameprodine...................               2  no change.
Betamethadol....................               4  no change.
Betaprodine.....................               2  no change.
Bufotenine......................               3  no change.
Butylone........................              25  no change.
Butyryl fentanyl................              30  no change.
Cathinone.......................              24  no change.
Codeine methylbromide...........              30  no change.
Codeine-N-oxide.................             192  no change.
Desomorphine....................              25  no change.
Diapromide......................            Zero  20.
Diethylthiambutene..............            Zero  20.
Diethyltryptamine...............              25  no change.
Difenoxin.......................           8,225  no change.
Dihydromorphine.................       1,000,160  no change.
Dimethyltryptamine..............              35  50.
Dipipanone......................               5  no change.
Etorphine.......................              30  no change.
Fenethylline....................              30  no change.
Furanyl fentanyl................              30  no change.
gamma-Hydroxybutyric acid.......      37,130,000  no change.
Heroin..........................              45  no change.
Hydromorphinol..................              40  no change.
Hydroxypethidine................               2  no change.
Ibogaine........................              30  no change.
JWH-018 and AM678 (1-Pentyl-3-(1-             35  no change.
 naphthoyl)indole).
JWH-019 (1-Hexyl-3-(1-                        45  no change.
 naphthoyl)indole).
JWH-073 (1-Butyl-3-(1-                        45  no change.
 naphthoyl)indole).
JWH-081 (1-Pentyl-3-[1-(4-                    30  no change.
 methoxynaphthoyl)]indole).
JWH-122 (1-Pentyl-3-(4-methyl-1-              30  no change.
 naphthoyl)indole).

[[Page 42694]]

 
JWH-200 (1-[2-(4-                             35  no change.
 Morpholinyl)ethyl]-3-(1-
 naphthoyl)indole).
JWH-203 (1-Pentyl-3-(2-                       30  no change.
 chlorophenylacetyl)indole).
JWH-250 (1-Pentyl-3-(2-                       30  no change.
 methoxyphenylacetyl)indole).
JWH-398 (1-Pentyl-3-(4-chloro-1-              30  no change.
 naphthoyl)indole).
Lysergic acid diethylamide (LSD)              40  no change.
MAB-CHMINACA; ADB-CHMINACA (N-(1-             30  no change.
 amino-3,3-dimethyl-1-oxobutan-2-
 yl)-1-(cyclohexylmethyl)-1H-
 indazole-3-carboxamide).
MDMB-CHMICA; MMB-CHMINACA(methyl              30  no change.
 2-(1-(cyclohexylmethyl)-1H-
 indole-3-carboxamido)-3,3-
 dimethylbutanoate).
MDMB-FUBINACA (methyl 2-(1-(4-                30  no change.
 fluorobenzyl)-1H-indazole-3-
 carboxamido)-3,3-
 dimethylbutanoate).
Marihuana.......................         443,680  1,140,216.
Mecloqualone....................              30  no change.
Mescaline.......................              25  no change.
Methaqualone....................              60  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................             150  no change.
N,N-Dimethylamphetamine.........              25  no change.
Naphyrone.......................              25  no change.
N-Ethyl-1-phenylcyclohexylamine.               5  no change.
N-Ethyl-3-piperidyl benzilate...            Zero  10.
N-Ethylamphetamine..............              24  no change.
N-Hydroxy-3,4-                                24  no change.
 methylenedioxyamphetamine.
Noracymethadol..................               2  no change.
Norlevorphanol..................              55  no change.
Normethadone....................               2  no change.
Normorphine.....................              40  no change.
Para-fluorofentanyl.............              25  no change.
Parahexyl.......................               5  no change.
PB-22; QUPIC....................              20  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.
SR-18 and RCS-8 (1-                           45  no change.
 Cyclohexylethyl-3-(2-
 methoxyphenylacetyl)indole).
SR-19 and RCS-4 (1-Pentyl-3-[(4-              30  no change.
 methoxy)-benzoyl]indole).
Tetrahydrocannabinols...........         384,460  no change.
Thiofentanyl....................              25  no change.
THJ-2201 ( [1-(5-fluoropentyl)-               30  no change.
 1H-indazol-3-yl](naphthalen-1-
 yl)methanone).
Tilidine........................              25  no change.
Trimeperidine...................               2  no change.
UR-144 (1-pentyl-1H-indol-3-                  25  no change.
 yl)(2,2,3,3-
 tetramethylcyclopropyl)methanon
 e.
U-47700.........................              30  no change.
------------------------------------------------------------------------
                               Schedule II
------------------------------------------------------------------------
1-Phenylcyclohexylamine.........               4  15.
1-                                             4  25.
 Piperidinocyclohexanecarbonitri
 le.
4-Anilino-N-phenethyl-4-               1,342,320  no change.
 piperidine (ANPP).
Alfentanil......................           6,200  no change.
Alphaprodine....................               2  no change.
Amobarbital.....................          20,100  no change.
Amphetamine (for conversion)....      11,280,000  12,700,000.
Amphetamine (for sale)..........      39,856,000  no change.
Anileridine.....................            Zero  20.
Carfentanil.....................              20  no change.
Cocaine.........................          92,120  no change.
Codeine (for conversion)........      15,040,000  12,900,000.
Codeine (for sale)..............      40,015,000  no change.
Dextropropoxyphene..............              35  no change.
Dihydrocodeine..................         264,140  no change.
Dihydroetorphine................               2  no change.
Diphenoxylate (for conversion)..          14,100  no change.
Diphenoxylate (for sale)........         770,800  no change.
Ecgonine........................          88,134  no change.
Ethylmorphine...................              30  no change.

[[Page 42695]]

 
Etorphine hydrochloride.........              32  no change.
Fentanyl........................       1,342,320  no change.
Glutethimide....................               2  no change.
Hydrocodone (for conversion)....         114,680  no change.
Hydrocodone (for sale)..........      50,348,280  44,710,000.
Hydromorphone...................       4,547,720  no change.
Isomethadone....................              30  no change.
Levo-alphacetylmethadol (LAAM)..               5  no change.
Levomethorphan..................              30  2,200.
Levorphanol.....................          12,126  38,000.
Lisdexamfetamine................      17,869,000  19,000,000.
Meperidine......................       2,717,540  1,913,148.
Meperidine Intermediate-A.......               5  30.
Meperidine Intermediate-B.......              30  no change.
Meperidine Intermediate-C.......               5  30.
Metazocine......................              15  no change.
Methadone (for sale)............      22,278,000  no change.
Methadone Intermediate..........      24,064,000  no change.
Methamphetamine.................       1,446,754  no change.
------------------------------------------------------------------------
[846,000 grams of levo-desoxyephedrine for use in a non-controlled, non-
 prescription product; 564,000 grams for methamphetamine mostly for
 conversion to a schedule III product; and 36,754 grams for
 methamphetamine (for sale)]
------------------------------------------------------------------------
Methylphenidate.................      64,600,000  no change.
Morphine (for conversion).......       4,089,000  no change.
Morphine (for sale).............      33,958,440  31,456,000.
Nabilone........................          31,000  62,000.
Noroxymorphone (for conversion).      14,044,540  16,440,000.
Noroxymorphone (for sale).......         376,000  no change.
Opium (powder)..................          84,600  no change.
Opium (tincture)................         564,000  no change.
Oripavine.......................      24,534,000  no change.
Oxycodone (for conversion)......       2,453,400  no change.
Oxycodone (for sale)............      95,692,000  85,578,000.
Oxymorphone (for conversion)....      20,962,000  no change.
Oxymorphone (for sale)..........       3,395,280  3,137,240.
Pentobarbital...................      25,850,000  no change.
Phenazocine.....................               5  no change.
Phencyclidine...................              35  no change.
Phenmetrazine...................              25  no change.
Phenylacetone...................              40  no change.
Racemethorphan..................               5  no change.
Racemorphan.....................               5  no change.
Remifentanil....................           2,820  3,000.
Secobarbital....................         161,682  172,100.
Sufentanil......................           1,880  no change.
Tapentadol......................      18,388,280  no change.
Thebaine........................      94,000,000  86,200,000.
------------------------------------------------------------------------
                            List I Chemicals
------------------------------------------------------------------------
Ephedrine (for conversion)......          47,000  no change.
Ephedrine (for sale)............       4,136,000  no change.
Phenylpropanolamine (for              14,100,000  no change.
 conversion).
Phenylpropanolamine (for sale)..       7,990,000  no change.
Pseudoephedrine (for conversion)              40  1,000.
Pseudoephedrine (for sale)......     180,000,000  no change.
------------------------------------------------------------------------

    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 2018 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 2018 aggregate production quotas 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).


[[Page 42696]]


    Dated: August 17, 2018.
Uttam Dhillon,
Acting Administrator.
[FR Doc. 2018-18265 Filed 8-22-18; 8:45 am]
 BILLING CODE 4410-09-P