83_FR_63769 83 FR 63533 - Final Adjusted 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

83 FR 63533 - Final Adjusted 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

DEPARTMENT OF JUSTICE
Drug Enforcement Administration

Federal Register Volume 83, Issue 236 (December 10, 2018)

Page Range63533-63538
FR Document2018-26587

This final order establishes the final adjusted 2018 aggregate production quotas for controlled substances in schedules I and II of the Controlled Substances Act (CSA) and the assessment of annual needs for the list I chemicals ephedrine, pseudoephedrine, and phenylpropanolamine.

Federal Register, Volume 83 Issue 236 (Monday, December 10, 2018)
[Federal Register Volume 83, Number 236 (Monday, December 10, 2018)]
[Notices]
[Pages 63533-63538]
From the Federal Register Online  [www.thefederalregister.org]
[FR Doc No: 2018-26587]


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DEPARTMENT OF JUSTICE

Drug Enforcement Administration

[Docket No. DEA-471A]


Final Adjusted 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 (DEA), Department of Justice 
(DOJ).

ACTION: Final order.

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

SUMMARY: This final order establishes the final adjusted 2018 aggregate 
production quotas for controlled substances in schedules I and II of 
the Controlled Substances Act (CSA) and the assessment of annual needs 
for the list I chemicals ephedrine, pseudoephedrine, and 
phenylpropanolamine.

DATES: This order is effective December 10, 2018.

FOR FURTHER INFORMATION CONTACT: Regulatory Drafting and Policy Support 
Section (DPW), Diversion Control Division, Drug Enforcement 
Administration, 8701 Morrissette Drive, Springfield, VA 22152, 
Telephone: (202) 598-6812.

SUPPLEMENTARY INFORMATION: 

Legal Authority

    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 substances 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 Drug Enforcement Administration (DEA) 
pursuant to 28 CFR 0.100.

Background

    The DEA published the 2018 established aggregate production quotas 
for controlled substances in schedules I and II and the assessment of 
annual needs for the list I chemicals ephedrine, pseudoephedrine, and 
phenylpropanolamine in the Federal Register on November 8, 2017. 82 FR 
51873. The DEA is committed to preventing and limiting diversion by 
enforcing laws and regulations regarding controlled substances and the 
list I chemicals ephedrine, pseudoephedrine, and phenylpropanolamine, 
in order to meet the demand of legitimate medical, scientific, and 
export needs of the United States. This notice stated that the 
Administrator would adjust, as needed, the established aggregate 
production quotas in 2018 in accordance with 21 CFR 1303.13 and 21 CFR 
1315.13. The 2018 proposed adjusted aggregate production quotas for 
controlled substances in schedules I and II and assessment of annual 
needs for the list I chemicals ephedrine, pseudoephedrine, and 
phenylpropanolamine were subsequently published in the Federal Register 
on August 23, 2018, (83 FR 42690) in consideration of the outlined 
criteria. All interested persons were invited to comment on or object 
to the proposed adjusted aggregate production quotas and assessment of 
annual needs on or before September 24, 2018.

Comments Received

    The DEA received 526 comments from doctors, nurses, veterinarians, 
nonprofit organizations, associations, patients, caregivers, DEA-
registered entities, and non-DEA entities. The comments included 
concerns about drug shortages, interference with doctor-patient 
relationships, increase in the production of marihuana, requests for a 
hearing, requests for increases in specific production quotas, and 
comments that were outside the scope of this final order.
    There were 200 commenters that expressed general concerns about the 
decrease to the production quotas of controlled substances and 
shortages of controlled substances. There were 27 commenters that 
expressed general concerns alleging that decreases to the aggregate 
production quotas interfered with doctor-patient relationships. The DEA 
sets aggregate production quotas in a manner to ensure that the 
estimated medical needs of the United States are met. In determining 
the aggregate production quota, the DEA does take into account the 
prescriptions that have been issued. The DEA does not interfere with 
doctor-patient relationships. Doctors who are authorized to dispense 
controlled substances are responsible for adhering to the laws and 
regulations set forth under the CSA, which requires doctors to only 
write prescriptions for a legitimate medical need. The DEA is 
responsible for enforcing controlled substance laws and regulations. 
The DEA is committed to ensuring an adequate and uninterrupted supply 
of controlled substances in order to meet the demand of legitimate 
medical, scientific, and export needs of the United States. The 
decrease or increase in the aggregate production quota for controlled 
substances is based on factors set forth in 21 CFR 1303.13. In the 
event of a shortage, the CSA provides a mechanism under which the DEA 
will, in appropriate circumstances, increase quotas to address 
shortages. 21 U.S.C. 826(h). When DEA is notified of an alleged 
shortage, DEA will confer with the FDA and relevant manufacturers 
regarding the amount of material in physical inventory, current quota 
granted, and the estimated legitimate medical need, to determine 
whether a quota adjustment is necessary to alleviate any factually 
valid shortage.
    Four non-DEA registered entities expressed support to increase the 
production quota of marihuana for research purposes. The DEA increased 
the production quota for marihuana based solely on increased usage 
projections for federally approved research projects.
    Two non-DEA-registered individuals urged DEA to hold a public 
hearing in connection with their view that reducing quotas will not be 
effective in

[[Page 63534]]

preventing the deaths and other harms associated with the opioid crisis 
in the United States. One of these individuals stated that the purpose 
of the hearing would be to obtain input from various medical 
professionals and patients. The second commenter expressed his view 
that reduction in quotas could lead to the under treatment of pain. 
Under the DEA regulations, the decision of whether to grant a hearing 
on the issues raised by the comments lies solely within the discretion 
of the Administrator. 21 CFR 1303.11(c) and 1303.13(c). I find that 
neither of the foregoing two comments, or any of the other comments, 
presented any evidence that would lead me to conclude that a hearing is 
necessary or warranted. Therefore, I decline to order a hearing on the 
issues presented by the comments.
    Five DEA-registered entities submitted comments regarding a total 
of 30 schedule I and II controlled substances. Comments received 
proposed that the aggregate production quotas for 3-methylfentanyl, 4-
ANPP, acetyl fentanyl, acryl fentanyl, beta-hydroxythiofentanyl, 
butyryl fentanyl, carfentanil, cyclopentyl fentanyl, cyclopropyl 
fentanyl, d-amphetamine (for conversion), diphenoxylate (for sale), 
fentanyl, fentanyl related substances, furanyl fentanyl, isobutyryl 
fentanyl, levorphanol, meperidine, methoxyacetyl fentanyl, 
noroxymorphone (for conversion), ocfentanil, oripavine, oxymorphone 
(for conversion), para-chloroisobutyryl fentanyl, para-fluorofentanyl, 
para-fluorobutyryl fentanyl, para-methyoxybutyryl fentanyl, 
remifentanil, tetrahydrofuranyl fentanyl, U-47700, and valeryl fentanyl 
were insufficient to provide for the estimated medical, scientific, 
research, and industrial needs of the United States, for export 
requirements, and for the establishment and maintenance of reserve 
stocks.
    The DEA received 288 comments which addressed issues that are 
outside the scope of this final order. The comments were general in 
nature and raised issues of specific medical illnesses, medical 
treatments, and medication costs and therefore, are outside of the 
scope of this Final Order for 2018 and do not impact the original 
analysis involved in finalizing the 2018 aggregate production quotas.
    The DEA received no comments from DEA-registered or non-DEA 
registered entities for previously established values of the 2018 
assessment of annual needs for ephedrine, pseudoephedrine, and 
phenylpropanolamine.

Analysis for Final Adjusted 2018 Aggregate Production Quotas and 
Assessment of Annual Needs

    In determining the final adjusted 2018 aggregate production quotas 
and assessment of annual needs, the DEA has taken into consideration 
the above comments that are specifically relevant to this Final Order 
for calendar year 2018 along with the factors set forth in 21 CFR 
1303.13 and 21 CFR 1315.13 in accordance with 21 U.S.C. 826(a), and 
other relevant factors including the 2017 year-end inventories, initial 
2018 manufacturing and import quotas, 2018 export requirements, actual 
and projected 2018 sales, research and product development 
requirements, additional applications received, and the extent of any 
diversion of the controlled substance in the class. Based on all of the 
above, the Administrator is adjusting the 2018 aggregate production 
quotas for the following: Lower for codeine (for sale), hydrocodone 
(for sale), morphine (for sale), and oxycodone (for sale) based on the 
data received since the publication of the 2018 Proposed Revised 
Aggregate Production Quotas and Assessment of Annual Needs in the 
Federal Register on August 23, 2018, (83 FR 42690); higher for 
cyclopentyl fentanyl, fentanyl related substances, methoxyacetyl 
fentanyl, para-chloroisobutyryl fentanyl, and para-methyoxybutyryl 
fentanyl due to the publication of their schedule I temporary 
controlled status; higher for noroxymorphone (for conversion) and 
oripavine based on their involvement in the synthesis pathway to 
produce the FDA approved drugs used in the medically assisted treatment 
of opioid addiction. This final order reflects those adjustments.
    Regarding 3-methyl fentanyl, 4-ANPP, acetyl fentanyl, acryl 
fentanyl, beta-hydroxythiofentanyl, butyryl fentanyl, carfentanil, 
cyclopropyl fentanyl, d-amphetamine (for conversion), diphenoxylate 
(for sale), fentanyl, furanyl fentanyl, isobutyryl fentanyl, 
levorphanol, meperidine, ocfentanil, oxymorphone (for conversion), 
para-fluorofentanyl, para-fluorobutyryl fentanyl, remifentanil, 
tetrahydrofuranyl fentanyl, U-47700, and valeryl fentanyl, the 
Administrator hereby determines that the proposed adjusted 2018 
aggregate production quotas and assessment of annual needs for these 
substances and list I chemicals as published on August 23, 2018, (83 FR 
42690) are sufficient to meet the current 2018 estimated medical, 
scientific, research, and industrial needs of the United States and to 
provide for adequate reserve stock. This final order establishes these 
aggregate production quotas at the same amounts as proposed.
    Pursuant to the above, the Administrator hereby finalizes the 2018 
aggregate production quotas for the following schedule I and II 
controlled substances and the 2018 assessment of annual needs for the 
list I chemicals ephedrine, pseudoephedrine, and phenylpropanolamine, 
expressed in grams of anhydrous acid or base, as follows:

------------------------------------------------------------------------
                                                           Final revised
                       Basic class                          2018 quotas
                                                                (g)
------------------------------------------------------------------------
                    Temporarily Scheduled Substances
------------------------------------------------------------------------
1-(4-Cyanobutyl)-N-(2-phenylpropan-2-yl)-1 H-indazole-3-              25
 carboxamide............................................
1-(5-Fluoropentyl)-N-(2-phenylpropan-2-yl)-1H-                        25
 pyrrolo[2,3-b]pyridine-3carboxamide....................
Cyclopropyl Fentanyl....................................              20
Cyclopentyl fentanyl....................................              30
Fentanyl related substances.............................              40
Isobutyryl Fentanyl.....................................              25
Methyl-2-(1-(cyclohexylmethyl)-1H-indole-3-carboxamido)-              25
 3-methylbutanoate......................................
Methoxyacetyl fentanyl..................................              30
N-(1-Amino-3-methyl-1-oxobutan-2-yl)-1-(5-fluoropentyl)-              25
 1H-indazole-3-carboxamide..............................
Naphthalen-1-yl 1-(5-fluoropentyl)-1H-indole-3-                       25
 carboxylate............................................
Ocfentanil..............................................              25
Ortho-fluorofentanyl....................................              30
Para-chloroisobutyryl fentanyl..........................              30
Para-fluorobutyryl fentanyl.............................              25

[[Page 63535]]

 
Para-methoxybutyryl fentanyl............................              30
Tetrahydrofuranyl fentanyl..............................               5
Valeryl fentanyl........................................              25
------------------------------------------------------------------------
                               Schedule I
------------------------------------------------------------------------
1-[1-(2-Thienyl)cyclohexyl]pyrrolidine..................              20
1-(1-Phenylcyclohexyl)pyrrolidine.......................              15
1-(2-Phenylethyl)-4-phenyl-4-acetoxypiperidine..........              10
1-(5-Fluoropentyl)-3-(1-naphthoyl)indole (AM2201).......              30
1-(5-Fluoropentyl)-3-(2-iodobenzoyl)indole (AM-694).....              30
1-[1-(2-Thienyl)cyclohexyl]piperidine...................              15
1-Benzylpiperazine......................................              25
1-Methyl-4-phenyl-4-propionoxypiperidine................              10
2-(2,5-Dimethoxy-4-ethylphenyl) ethanamine (2C-E).......              30
2-(2,5-Dimethoxy-4-methylphenyl) ethanamine (2C-D)......              30
2-(2,5-Dimethoxy-4-nitro-phenyl) ethanamine (2C-N)......              30
2-(2,5-Dimethoxy-4-n-propylphenyl) ethanamine (2C-P)....              30
2-(2,5-Dimethoxyphenyl) ethanamine (2C-H)...............              30
2-(4-Bromo-2,5-dimethoxyphenyl)-N-(2-methoxybenzyl)                   30
 ethanamine (25B-NBOMe; 2C-B-NBOMe; 25B; Cimbi-36)......
2-(4-Chloro-2,5-dimethoxyphenyl) ethanamine (2C-C)......              30
2-(4-Chloro-2,5-dimethoxyphenyl)-N-(2-methoxybenzyl)                  25
 ethanamine (25C-NBOMe; 2C-C-NBOMe; 25C; Cimbi-82)......
2-(4-iodo-2,5-dimethoxyphenyl) ethanamine (2C-I)........              30
2-(4-iodo-2,5-dimethoxyphenyl)-N-(2-methoxybenzyl)                    30
 ethanamine (25I-NBOMe; 2C-I-NBOMe; 25I; Cimbi-5).......
2,5-Dimethoxy-4-ethylamphetamine (DOET).................              25
2,5-Dimethoxy-4-(n)-propylthiophenethylamine............              25
2,5-Dimethoxyamphetamine................................              25
2-(4-Ethylthio-2,5-dimethoxyphenyl)ethanamine (2C-T-2)..              30
2-(4-Isopropylthio)-2,5-dimethoxyphenyl)ethanamine (2C-T-             30
 4).....................................................
3,4,5-Trimethoxyamphetamine.............................              30
3,4-Methylenedioxyamphetamine (MDA).....................              55
3,4-Methylenedioxymethamphetamine (MDMA)................              50
3,4-Methylenedioxy-N-ethylamphetamine (MDEA)............              40
3,4-Methylenedioxy-N-methylcathinone (methylone)........              40
3,4-Methylenedioxypyrovalerone (MDPV)...................              35
3-FMC; 3-Fluoro-N-methylcathinone.......................              25
3-Methylfentanyl........................................              30
3-Methylthiofentanyl....................................              30
4-Bromo-2,5-dimethoxyamphetamine (DOB)..................              30
4-Bromo-2,5-dimethoxyphenethylamine (2C-B)..............              25
4-Fluoroisobutyryl fentanyl.............................              30
4-FMC; Flephedrone......................................              25
4-MEC; 4-Methyl-N-ethylcathinone........................              25
4-Methoxyamphetamine....................................             150
4-Methyl-2,5-dimethoxyamphetamine (DOM).................              25
4-Methylaminorex........................................              25
4-Methyl-N-methylcathinone (mephedrone).................              45
4-Methyl-[alpha]-pyrrolidinopropiophenone (4-MePPP).....              25
5-(1,1-Dimethylheptyl)-2-[(1R,3S)-3-hydroxycyclohexyl]-               50
 phenol.................................................
5-(1,1-Dimethyloctyl)-2-[(1R,3S)3-hydroxycyclohexyl-                  40
 phenol) (cannabicyclohexanol or CP-47,497 C8 Homolog)..
5F-ADB; 5F-MDMB-PINACA (Methyl 2-(1-(5-fluoropentyl)-1H-              30
 indazole-3-carboxamido)-3,3-dimethylbutanoate).........
5F-AMB (Methyl 2-(1-(5-fluoropentyl)-1H-indazole-3-                   30
 carboxamido)-3-methylbutanoate)........................
5F-APINACA; 5F-AKB48 (N-(adamantan-1-yl)-1-(5-                        30
 fluoropentyl)-1H-indazole-3-carboxamide)...............
5-Fluoro-PB-22; 5F-PB-22................................              20
5-Fluoro-UR-144, XLR11 [1-(5-Fluoro-pentyl)-1Hindol-3-                25
 yl](2,2,3,3-tetramethylcyclopropyl)methanone...........
5-Methoxy-3,4-methylenedioxyamphetamine.................              25
5-Methoxy-N,N-diisopropyltryptamine.....................              25
5-Methoxy-N-N-dimethyltryptamine........................              25
AB-CHMINACA.............................................              30
AB-FUBINACA.............................................              50
AB-PINACA...............................................              30
ADB-FUBINACA (N-(1-amino-3,3-dimethyl-1-oxobutan-2-yl)-1-             30
 (4-fluorobenzyl)-1H-indazole-3-carboxamide)............
Acetyl Fentanyl.........................................             100
Acetyl-alpha-methylfentanyl.............................              30
Acetyldihydrocodeine....................................              30
Acetylmethadol..........................................               2
Acryl fentanyl..........................................              25
ADB-PINACA (N-(1-amino-3,3-dimethyl-1-oxobutan-2-yl)-1-               50
 pentyl-1H-indazole-3-carboxamide)......................
AH-7921.................................................              30
Allylprodine............................................               2
Alphacetylmethadol......................................               2
alpha-ethyltryptamine...................................              25

[[Page 63536]]

 
Alphameprodine..........................................               2
Alphamethadol...........................................               2
alpha-methylfentanyl....................................              30
alpha-methylthiofentanyl................................              30
alpha-methyltryptamine (AMT)............................              25
alpha-Pyrrolidinobutiophenone ([alpha]-PBP).............              25
alpha-Pyrrolidinopentiophenone ([alpha]-PVP)............              25
Aminorex................................................              25
Anileridine.............................................              20
APINACA, AKB48 (N-(1-Adamantyl)-1-pentyl-1H-indazole-3-               25
 carboxamide)...........................................
Benzylmorphine..........................................              30
Betacetylmethadol.......................................               2
beta-Hydroxy-3-methylfentanyl...........................              30
beta-Hydroxyfentanyl....................................              30
beta-Hydroxythiofentanyl................................              30
Betameprodine...........................................               2
Betamethadol............................................               4
Betaprodine.............................................               2
Bufotenine..............................................               3
Butylone................................................              25
Butyryl fentanyl........................................              30
Cathinone...............................................              24
Codeine methylbromide...................................              30
Codeine-N-oxide.........................................             192
Desomorphine............................................              25
Diampromide.............................................              20
Diethylthiambutene......................................              20
Diethyltryptamine.......................................              25
Difenoxin...............................................           8,225
Dihydromorphine.........................................       1,000,160
Dimethyltryptamine......................................              50
Dipipanone..............................................               5
Etorphine...............................................              30
Fenethylline............................................              30
Furanyl fentanyl........................................              30
Gamma-Hydroxybutyric Acid...............................      37,130,000
Heroin..................................................              45
Hydromorphinol..........................................              40
Hydroxypethidine........................................               2
Ibogaine................................................              30
JWH-018 and AM678 (1-Pentyl-3-(1-naphthoyl) indole).....              35
JWH-019 (1-Hexyl-3-(1-naphthoyl)indole).................              45
JWH-073 (1-Butyl-3-(1-naphthoyl)indole).................              45
JWH-081 (1-Pentyl-3-(1-(4-methoxynaphthoyl)] indole)....              30
JWH-122 (1-Pentyl-3-(4-methyl-1-naphthoyl) indole)......              30
JWH-200 (1-[2-(4-Morpholinyl)ethyl]-3-(1-                             35
 naphthoyl)indole)......................................
JWH-203 (1-Pentyl-3-(2-chlorophenylacetyl) indole)......              30
JWH-250 (1-Pentyl-3-(2-methoxyphenylacetyl) indole).....              30
JWH-398 (1-Pentyl-3-(4-chloro-1-naphthoyl) indole)......              30
Lysergic acid diethylamide (LSD)........................              40
MAB-CHMINACA; ADB-CHMINACA (N-(1-amino-3,3dimethyl-1-                 30
 oxobutan-2-yl)-1-(cyclohexylmethyl)-1H-indazole-3-
 carboxamide)...........................................
MDMB-CHMICA; MMB-CHMINACA(Methyl 2-(1-(cyclohexylmethyl)-             30
 1H-indole-3-carboxamido)-3,3-dimethylbutanoate)........
MDMB-FUBINACA (methyl 2-(1-(4-fluorobenzyl)-1H-indazole-              30
 3-carboxamido)-3,3-dimethylbutanoate)..................
Marihuana...............................................       1,140,216
Mecloqualone............................................              30
Mescaline...............................................              25
Methaqualone............................................              60
Methcathinone...........................................              25
Methyldesorphine........................................               5
Methyldihydromorphine...................................               2
Morphine methylbromide..................................               5
Morphine methylsulfonate................................               5
Morphine-N-oxide........................................             150
N,N-Dimethylamphetamine.................................              25
Naphyrone...............................................              25
N-Ethyl-1-phenylcyclohexylamine.........................               5
N-Ethyl-3-piperidyl benzilate...........................              10
N-Ethylamphetamine......................................              24
N-Hydroxy-3,4-methylenedioxyamphetamine.................              24
Noracymethadol..........................................               2
Norlevorphanol..........................................              55

[[Page 63537]]

 
Normethadone............................................               2
Normorphine.............................................              40
Para-fluorofentanyl.....................................              25
Parahexyl...............................................               5
PB-22; QUPIC............................................              20
Pentedrone..............................................              25
Pentylone...............................................              25
Phenomorphan............................................               2
Pholcodine..............................................               5
Psilocybin..............................................              30
Psilocyn................................................              50
SR-18 and RCS-8 (1-Cyclohexylethyl-3-(2-                              45
 methoxyphenylacetyl)indole)............................
SR-19 and RCS-4 (1-Pentyl-3-[(4-methoxy)-benzoyl]indole)              30
Tetrahydrocannabinols...................................         384,460
Thiofentanyl............................................              25
THJ-2201 ([1-(5-fluoropentyl)-1H-indazol-3-                           30
 yl](naphthalen-1-yl) methanone)........................
Tilidine................................................              25
Trimeperidine...........................................               2
UR-144 (1-Pentyl-1H-indol-3-yl)(2,2,3,3-                              25
 tetramethylcyclopropyl) methanone......................
U-47700.................................................              30
------------------------------------------------------------------------
                               Schedule II
------------------------------------------------------------------------
1-Phenylcyclohexylamine.................................              15
1-Piperidinocyclohexanecarbonitrile.....................              25
4-Anilino-N-phenethyl-4-piperidine (ANPP)...............       1,342,000
Alfentanil..............................................           6,200
Alphaprodine............................................               2
Amobarbital.............................................          20,100
Amphetamine (for conversion)............................      12,000,000
Amphetamine (for sale)..................................      39,856,000
Carfentanil.............................................              20
Cocaine.................................................          92,120
Codeine (for conversion)................................      13,536,000
Codeine (for sale)......................................      36,114,260
Dextropropoxyphene......................................              35
Dihydrocodeine..........................................         264,140
Dihydroetorphine........................................               2
Diphenoxylate (for conversion)..........................          14,100
Diphenoxylate (for sale)................................         770,800
Ecgonine................................................          88,134
Ethylmorphine...........................................              30
Etorphine hydrochloride.................................              32
Fentanyl................................................       1,342,320
Glutethimide............................................               2
Hydrocodone (for conversion)............................         114,680
Hydrocodone (for sale)..................................      43,027,640
Hydromorphone...........................................       4,547,720
Isomethadone............................................              30
Levo-alphacetylmethadol (LAAM)..........................               5
Levomethorphan..........................................           2,200
Levorphanol.............................................          38,000
Lisdexamfetamine........................................      19,000,000
Meperidine..............................................       1,913,148
Meperidine Intermediate-A...............................              30
Meperidine Intermediate-B...............................              30
Meperidine Intermediate-C...............................              30
Metazocine..............................................              15
Methadone (for sale)....................................      22,278,000
Methadone Intermediate..................................      24,064,000
Methamphetamine.........................................       1,446,754
------------------------------------------------------------------------
[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
Morphine (for conversion)...............................       4,089,000
Morphine (for sale).....................................      29,353,676
Nabilone................................................          62,000
Noroxymorphone (for conversion).........................      17,804.670
Noroxymorphone (for sale)...............................         376,000
Opium (powder)..........................................          84,600

[[Page 63538]]

 
Opium (tincture)........................................         564,000
Oripavine...............................................      26,629,500
Oxycodone (for conversion)..............................       2,453,400
Oxycodone (for sale)....................................      79,596,606
Oxymorphone (for conversion)............................      20,962,000
Oxymorphone (for sale)..................................       3,137,240
Pentobarbital...........................................      25,850,000
Phenazocine.............................................               5
Phencyclidine...........................................              35
Phenmetrazine...........................................              25
Phenylacetone...........................................              40
Racemethorphan..........................................               5
Racemorphan.............................................               5
Remifentanil............................................           3,000
Secobarbital............................................         172,100
Sufentanil..............................................           1,880
Tapentadol..............................................      18,388,280
Thebaine................................................      84,600,000
------------------------------------------------------------------------
                            List I Chemicals
------------------------------------------------------------------------
Ephedrine (for conversion)..............................          47,000
Ephedrine (for sale)....................................       4,136,000
Phenylpropanolamine (for conversion)....................      14,100,000
Phenylpropanolamine (for sale)..........................       7,990,000
Pseudoephedrine (for conversion)........................           1,000
Pseudoephedrine (for sale)..............................     180,000,000
------------------------------------------------------------------------

    Aggregate production quotas for all other schedule I and II 
controlled substances included in 21 CFR 1308.11 and 1308.12 remain at 
zero.

    Dated: December 3, 2018.
Uttam Dhillon,
Acting Administrator.
[FR Doc. 2018-26587 Filed 12-7-18; 8:45 am]
 BILLING CODE 4410-09-P



                                Federal Register / Vol. 83, No. 236 / Monday, December 10, 2018 / Notices                                           63533

     Accordingly, effective October 18, 2018,                DATES: This order is effective December               patients, caregivers, DEA-registered
     the Commission, pursuant to sections                    10, 2018.                                             entities, and non-DEA entities. The
     703(a) and 733(a) of the Act (19 U.S.C.                 FOR FURTHER INFORMATION CONTACT:                      comments included concerns about
     1671b(a) and 1673b(a)), instituted                      Regulatory Drafting and Policy Support                drug shortages, interference with doctor-
     countervailing duty investigation Nos.                  Section (DPW), Diversion Control                      patient relationships, increase in the
     701–TA–612–613 and antidumping                          Division, Drug Enforcement                            production of marihuana, requests for a
     duty investigation Nos. 731–TA–1429–                    Administration, 8701 Morrissette Drive,               hearing, requests for increases in
     1430 (Preliminary).                                     Springfield, VA 22152, Telephone: (202)               specific production quotas, and
        Notice of the institution of the                     598–6812.                                             comments that were outside the scope
     Commission’s investigations and of a                    SUPPLEMENTARY INFORMATION:                            of this final order.
     public conference to be held in                                                                                  There were 200 commenters that
     connection therewith was given by                       Legal Authority                                       expressed general concerns about the
     posting copies of the notice in the Office                Section 306 of the Controlled                       decrease to the production quotas of
     of the Secretary, U.S. International                    Substances Act (CSA) (21 U.S.C. 826)                  controlled substances and shortages of
     Trade Commission, Washington, DC,                       requires the Attorney General to                      controlled substances. There were 27
     and by publishing the notice in the                     establish aggregate production quotas                 commenters that expressed general
     Federal Register of October 25, 2018 (83                for each basic class of controlled                    concerns alleging that decreases to the
     FR 53899). The conference was held in                   substances listed in schedules I and II               aggregate production quotas interfered
     Washington, DC, on November 8, 2018,                    and for the list I chemicals ephedrine,               with doctor-patient relationships. The
     and all persons who requested the                       pseudoephedrine, and                                  DEA sets aggregate production quotas in
     opportunity were permitted to appear in                 phenylpropanolamine. The Attorney                     a manner to ensure that the estimated
     person or by counsel.                                   General has delegated this function to                medical needs of the United States are
        The Commission made these                            the Administrator of the Drug                         met. In determining the aggregate
     determinations pursuant to sections                     Enforcement Administration (DEA)                      production quota, the DEA does take
     703(a) and 733(a) of the Act (19 U.S.C.                 pursuant to 28 CFR 0.100.                             into account the prescriptions that have
     1671b(a) and 1673b(a)). It completed                                                                          been issued. The DEA does not interfere
                                                             Background                                            with doctor-patient relationships.
     and filed its determinations in these
     investigations on December 3, 2018. The                    The DEA published the 2018                         Doctors who are authorized to dispense
     views of the Commission are contained                   established aggregate production quotas               controlled substances are responsible
     in USITC Publication 4858 (December                     for controlled substances in schedules I              for adhering to the laws and regulations
     2018), entitled Polyester Textured Yarn                 and II and the assessment of annual                   set forth under the CSA, which requires
     from China and India: Investigation                     needs for the list I chemicals ephedrine,             doctors to only write prescriptions for a
     Nos. 701–TA–612–613 and 731–TA–                         pseudoephedrine, and                                  legitimate medical need. The DEA is
     1429–1430 (Preliminary).                                phenylpropanolamine in the Federal                    responsible for enforcing controlled
                                                             Register on November 8, 2017. 82 FR                   substance laws and regulations. The
       By order of the Commission.                           51873. The DEA is committed to                        DEA is committed to ensuring an
       Issued: December 3, 2018.                             preventing and limiting diversion by                  adequate and uninterrupted supply of
     Lisa Barton,                                            enforcing laws and regulations                        controlled substances in order to meet
     Secretary to the Commission.                            regarding controlled substances and the               the demand of legitimate medical,
     [FR Doc. 2018–26604 Filed 12–7–18; 8:45 am]             list I chemicals ephedrine,                           scientific, and export needs of the
     BILLING CODE 7020–02–P                                  pseudoephedrine, and                                  United States. The decrease or increase
                                                             phenylpropanolamine, in order to meet                 in the aggregate production quota for
                                                             the demand of legitimate medical,                     controlled substances is based on factors
     DEPARTMENT OF JUSTICE                                   scientific, and export needs of the                   set forth in 21 CFR 1303.13. In the event
                                                             United States. This notice stated that the            of a shortage, the CSA provides a
     Drug Enforcement Administration                         Administrator would adjust, as needed,                mechanism under which the DEA will,
                                                             the established aggregate production                  in appropriate circumstances, increase
     [Docket No. DEA–471A]
                                                             quotas in 2018 in accordance with 21                  quotas to address shortages. 21 U.S.C.
     Final Adjusted Aggregate Production                     CFR 1303.13 and 21 CFR 1315.13. The                   826(h). When DEA is notified of an
     Quotas for Schedule I and II Controlled                 2018 proposed adjusted aggregate                      alleged shortage, DEA will confer with
     Substances and Assessment of                            production quotas for controlled                      the FDA and relevant manufacturers
     Annual Needs for the List I Chemicals                   substances in schedules I and II and                  regarding the amount of material in
     Ephedrine, Pseudoephedrine, and                         assessment of annual needs for the list               physical inventory, current quota
     Phenylpropanolamine for 2018                            I chemicals ephedrine,                                granted, and the estimated legitimate
                                                             pseudoephedrine, and                                  medical need, to determine whether a
     AGENCY:   Drug Enforcement                              phenylpropanolamine were                              quota adjustment is necessary to
     Administration (DEA), Department of                     subsequently published in the Federal                 alleviate any factually valid shortage.
     Justice (DOJ).                                          Register on August 23, 2018, (83 FR                      Four non-DEA registered entities
     ACTION: Final order.                                    42690) in consideration of the outlined               expressed support to increase the
                                                             criteria. All interested persons were                 production quota of marihuana for
     SUMMARY:   This final order establishes                 invited to comment on or object to the                research purposes. The DEA increased
     the final adjusted 2018 aggregate                       proposed adjusted aggregate production                the production quota for marihuana
     production quotas for controlled                        quotas and assessment of annual needs                 based solely on increased usage
     substances in schedules I and II of the                 on or before September 24, 2018.                      projections for federally approved
     Controlled Substances Act (CSA) and                                                                           research projects.
     the assessment of annual needs for the                  Comments Received                                        Two non-DEA-registered individuals
     list I chemicals ephedrine,                                The DEA received 526 comments                      urged DEA to hold a public hearing in
     pseudoephedrine, and                                    from doctors, nurses, veterinarians,                  connection with their view that
     phenylpropanolamine.                                    nonprofit organizations, associations,                reducing quotas will not be effective in


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     63534                                 Federal Register / Vol. 83, No. 236 / Monday, December 10, 2018 / Notices

     preventing the deaths and other harms                                          The DEA received 288 comments                                             higher for cyclopentyl fentanyl, fentanyl
     associated with the opioid crisis in the                                    which addressed issues that are outside                                      related substances, methoxyacetyl
     United States. One of these individuals                                     the scope of this final order. The                                           fentanyl, para-chloroisobutyryl fentanyl,
     stated that the purpose of the hearing                                      comments were general in nature and                                          and para-methyoxybutyryl fentanyl due
     would be to obtain input from various                                       raised issues of specific medical                                            to the publication of their schedule I
     medical professionals and patients. The                                     illnesses, medical treatments, and                                           temporary controlled status; higher for
     second commenter expressed his view                                         medication costs and therefore, are                                          noroxymorphone (for conversion) and
     that reduction in quotas could lead to                                      outside of the scope of this Final Order                                     oripavine based on their involvement in
     the under treatment of pain. Under the                                      for 2018 and do not impact the original                                      the synthesis pathway to produce the
     DEA regulations, the decision of                                            analysis involved in finalizing the 2018                                     FDA approved drugs used in the
     whether to grant a hearing on the issues                                    aggregate production quotas.                                                 medically assisted treatment of opioid
     raised by the comments lies solely                                             The DEA received no comments from                                         addiction. This final order reflects those
     within the discretion of the                                                DEA-registered or non-DEA registered                                         adjustments.
     Administrator. 21 CFR 1303.11(c) and                                        entities for previously established                                             Regarding 3-methyl fentanyl, 4–
     1303.13(c). I find that neither of the                                      values of the 2018 assessment of annual                                      ANPP, acetyl fentanyl, acryl fentanyl,
     foregoing two comments, or any of the                                       needs for ephedrine, pseudoephedrine,                                        beta-hydroxythiofentanyl, butyryl
     other comments, presented any                                               and phenylpropanolamine.
                                                                                                                                                              fentanyl, carfentanil, cyclopropyl
     evidence that would lead me to                                              Analysis for Final Adjusted 2018                                             fentanyl, d-amphetamine (for
     conclude that a hearing is necessary or                                     Aggregate Production Quotas and                                              conversion), diphenoxylate (for sale),
     warranted. Therefore, I decline to order                                    Assessment of Annual Needs                                                   fentanyl, furanyl fentanyl, isobutyryl
     a hearing on the issues presented by the                                                                                                                 fentanyl, levorphanol, meperidine,
     comments.                                                                     In determining the final adjusted 2018
                                                                                 aggregate production quotas and                                              ocfentanil, oxymorphone (for
        Five DEA-registered entities
                                                                                 assessment of annual needs, the DEA                                          conversion), para-fluorofentanyl, para-
     submitted comments regarding a total of
                                                                                 has taken into consideration the above                                       fluorobutyryl fentanyl, remifentanil,
     30 schedule I and II controlled
                                                                                 comments that are specifically relevant                                      tetrahydrofuranyl fentanyl, U–47700,
     substances. Comments received
     proposed that the aggregate production                                      to this Final Order for calendar year                                        and valeryl fentanyl, the Administrator
     quotas for 3-methylfentanyl, 4–ANPP,                                        2018 along with the factors set forth in                                     hereby determines that the proposed
     acetyl fentanyl, acryl fentanyl, beta-                                      21 CFR 1303.13 and 21 CFR 1315.13 in                                         adjusted 2018 aggregate production
     hydroxythiofentanyl, butyryl fentanyl,                                      accordance with 21 U.S.C. 826(a), and                                        quotas and assessment of annual needs
     carfentanil, cyclopentyl fentanyl,                                          other relevant factors including the 2017                                    for these substances and list I chemicals
     cyclopropyl fentanyl, d-amphetamine                                         year-end inventories, initial 2018                                           as published on August 23, 2018, (83 FR
     (for conversion), diphenoxylate (for                                        manufacturing and import quotas, 2018                                        42690) are sufficient to meet the current
     sale), fentanyl, fentanyl related                                           export requirements, actual and                                              2018 estimated medical, scientific,
     substances, furanyl fentanyl, isobutyryl                                    projected 2018 sales, research and                                           research, and industrial needs of the
     fentanyl, levorphanol, meperidine,                                          product development requirements,                                            United States and to provide for
     methoxyacetyl fentanyl,                                                     additional applications received, and                                        adequate reserve stock. This final order
     noroxymorphone (for conversion),                                            the extent of any diversion of the                                           establishes these aggregate production
     ocfentanil, oripavine, oxymorphone (for                                     controlled substance in the class. Based                                     quotas at the same amounts as
     conversion), para-chloroisobutyryl                                          on all of the above, the Administrator is                                    proposed.
     fentanyl, para-fluorofentanyl, para-                                        adjusting the 2018 aggregate production                                         Pursuant to the above, the
     fluorobutyryl fentanyl, para-                                               quotas for the following: Lower for                                          Administrator hereby finalizes the 2018
     methyoxybutyryl fentanyl, remifentanil,                                     codeine (for sale), hydrocodone (for                                         aggregate production quotas for the
     tetrahydrofuranyl fentanyl, U–47700,                                        sale), morphine (for sale), and                                              following schedule I and II controlled
     and valeryl fentanyl were insufficient to                                   oxycodone (for sale) based on the data                                       substances and the 2018 assessment of
     provide for the estimated medical,                                          received since the publication of the                                        annual needs for the list I chemicals
     scientific, research, and industrial needs                                  2018 Proposed Revised Aggregate                                              ephedrine, pseudoephedrine, and
     of the United States, for export                                            Production Quotas and Assessment of                                          phenylpropanolamine, expressed in
     requirements, and for the establishment                                     Annual Needs in the Federal Register                                         grams of anhydrous acid or base, as
     and maintenance of reserve stocks.                                          on August 23, 2018, (83 FR 42690);                                           follows:

                                                                                                                                                                                                                Final revised
                                                                                                Basic class                                                                                                     2018 quotas
                                                                                                                                                                                                                     (g)

                                                                                        Temporarily Scheduled Substances

     1-(4-Cyanobutyl)-N-(2-phenylpropan-2-yl)-1 H-indazole-3-carboxamide ............................................................................................                                                      25
     1-(5-Fluoropentyl)-N-(2-phenylpropan-2-yl)-1H-pyrrolo[2,3-b]pyridine-3carboxamide ........................................................................                                                            25
     Cyclopropyl Fentanyl ...........................................................................................................................................................................                      20
     Cyclopentyl fentanyl .............................................................................................................................................................................                    30
     Fentanyl related substances ................................................................................................................................................................                          40
     Isobutyryl Fentanyl ...............................................................................................................................................................................                   25
     Methyl-2-(1-(cyclohexylmethyl)-1H-indole-3-carboxamido)-3-methylbutanoate ..................................................................................                                                          25
     Methoxyacetyl fentanyl ........................................................................................................................................................................                       30
     N-(1-Amino-3-methyl-1-oxobutan-2-yl)-1-(5-fluoropentyl)-1H-indazole-3-carboxamide ......................................................................                                                              25
     Naphthalen-1-yl 1-(5-fluoropentyl)-1H-indole-3-carboxylate ................................................................................................................                                           25
     Ocfentanil .............................................................................................................................................................................................              25
     Ortho-fluorofentanyl .............................................................................................................................................................................                    30
     Para-chloroisobutyryl fentanyl .............................................................................................................................................................                          30
     Para-fluorobutyryl fentanyl ...................................................................................................................................................................                       25



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                                           Federal Register / Vol. 83, No. 236 / Monday, December 10, 2018 / Notices                                                                                                63535

                                                                                                                                                                                                               Final revised
                                                                                               Basic class                                                                                                     2018 quotas
                                                                                                                                                                                                                    (g)

     Para-methoxybutyryl fentanyl ..............................................................................................................................................................                          30
     Tetrahydrofuranyl fentanyl ...................................................................................................................................................................                        5
     Valeryl fentanyl ....................................................................................................................................................................................                25

                                                                                                             Schedule I

     1-[1-(2-Thienyl)cyclohexyl]pyrrolidine ..................................................................................................................................................                            20
     1-(1-Phenylcyclohexyl)pyrrolidine ........................................................................................................................................................                           15
     1-(2-Phenylethyl)-4-phenyl-4-acetoxypiperidine ..................................................................................................................................                                    10
     1-(5-Fluoropentyl)-3-(1-naphthoyl)indole (AM2201) ............................................................................................................................                                       30
     1-(5-Fluoropentyl)-3-(2-iodobenzoyl)indole (AM–694) .........................................................................................................................                                        30
     1-[1-(2-Thienyl)cyclohexyl]piperidine ...................................................................................................................................................                            15
     1-Benzylpiperazine ..............................................................................................................................................................................                    25
     1-Methyl-4-phenyl-4-propionoxypiperidine ...........................................................................................................................................                                 10
     2-(2,5-Dimethoxy-4-ethylphenyl) ethanamine (2C–E) .........................................................................................................................                                          30
     2-(2,5-Dimethoxy-4-methylphenyl) ethanamine (2C–D) ......................................................................................................................                                            30
     2-(2,5-Dimethoxy-4-nitro-phenyl) ethanamine (2C–N) ........................................................................................................................                                          30
     2-(2,5-Dimethoxy-4-n-propylphenyl) ethanamine (2C–P) ....................................................................................................................                                            30
     2-(2,5-Dimethoxyphenyl) ethanamine (2C–H) .....................................................................................................................................                                      30
     2-(4-Bromo-2,5-dimethoxyphenyl)-N-(2-methoxybenzyl) ethanamine (25B-NBOMe; 2C-B-NBOMe; 25B; Cimbi-36) .......................                                                                                        30
     2-(4-Chloro-2,5-dimethoxyphenyl) ethanamine (2C-C) .......................................................................................................................                                           30
     2-(4-Chloro-2,5-dimethoxyphenyl)-N-(2-methoxybenzyl) ethanamine (25C-NBOMe; 2C-C-NBOMe; 25C; Cimbi-82) ......................                                                                                        25
     2-(4-iodo-2,5-dimethoxyphenyl) ethanamine (2C-I) .............................................................................................................................                                       30
     2-(4-iodo-2,5-dimethoxyphenyl)-N-(2-methoxybenzyl) ethanamine (25I-NBOMe; 2C-I-NBOMe; 25I; Cimbi-5) .................................                                                                                30
     2,5-Dimethoxy-4-ethylamphetamine (DOET) ......................................................................................................................................                                       25
     2,5-Dimethoxy-4-(n)-propylthiophenethylamine ...................................................................................................................................                                     25
     2,5-Dimethoxyamphetamine ................................................................................................................................................................                            25
     2-(4-Ethylthio-2,5-dimethoxyphenyl)ethanamine (2C–T–2) .................................................................................................................                                             30
     2-(4-Isopropylthio)-2,5-dimethoxyphenyl)ethanamine (2C–T–4) .........................................................................................................                                                30
     3,4,5-Trimethoxyamphetamine ............................................................................................................................................................                             30
     3,4-Methylenedioxyamphetamine (MDA) ............................................................................................................................................                                     55
     3,4-Methylenedioxymethamphetamine (MDMA) .................................................................................................................................                                           50
     3,4-Methylenedioxy-N-ethylamphetamine (MDEA) .............................................................................................................................                                           40
     3,4-Methylenedioxy-N-methylcathinone (methylone) ..........................................................................................................................                                          40
     3,4-Methylenedioxypyrovalerone (MDPV) ...........................................................................................................................................                                    35
     3-FMC; 3-Fluoro-N-methylcathinone ...................................................................................................................................................                                25
     3-Methylfentanyl ...................................................................................................................................................................................                 30
     3-Methylthiofentanyl .............................................................................................................................................................................                   30
     4-Bromo-2,5-dimethoxyamphetamine (DOB) ......................................................................................................................................                                        30
     4-Bromo-2,5-dimethoxyphenethylamine (2C–B) .................................................................................................................................                                         25
     4-Fluoroisobutyryl fentanyl ...................................................................................................................................................................                      30
     4-FMC; Flephedrone ............................................................................................................................................................................                      25
     4-MEC; 4-Methyl-N-ethylcathinone ......................................................................................................................................................                              25
     4-Methoxyamphetamine ......................................................................................................................................................................                         150
     4-Methyl-2,5-dimethoxyamphetamine (DOM) ......................................................................................................................................                                       25
     4-Methylaminorex ................................................................................................................................................................................                    25
     4-Methyl-N-methylcathinone (mephedrone) ........................................................................................................................................                                     45
     4-Methyl-α-pyrrolidinopropiophenone (4-MePPP) ...............................................................................................................................                                        25
     5-(1,1-Dimethylheptyl)-2-[(1R,3S)-3-hydroxycyclohexyl]-phenol .........................................................................................................                                              50
     5-(1,1-Dimethyloctyl)-2-[(1R,3S)3-hydroxycyclohexyl-phenol) (cannabicyclohexanol or CP–47,497 C8 Homolog) ..........................                                                                                 40
     5F-ADB; 5F-MDMB-PINACA (Methyl 2-(1-(5-fluoropentyl)-1H-indazole-3-carboxamido)-3,3-dimethylbutanoate) ............................                                                                                  30
     5F-AMB (Methyl 2-(1-(5-fluoropentyl)-1H-indazole-3-carboxamido)-3-methylbutanoate) ...................................................................                                                               30
     5F-APINACA; 5F-AKB48 (N-(adamantan-1-yl)-1-(5-fluoropentyl)-1H-indazole-3-carboxamide) ........................................................                                                                      30
     5-Fluoro-PB-22; 5F-PB-22 ...................................................................................................................................................................                         20
     5-Fluoro-UR-144, XLR11 [1-(5-Fluoro-pentyl)-1Hindol-3-yl](2,2,3,3-tetramethylcyclopropyl)methanone ...........................................                                                                       25
     5-Methoxy-3,4-methylenedioxyamphetamine ......................................................................................................................................                                       25
     5-Methoxy-N,N-diisopropyltryptamine ..................................................................................................................................................                               25
     5-Methoxy-N-N-dimethyltryptamine .....................................................................................................................................................                               25
     AB–CHMINACA ...................................................................................................................................................................................                      30
     AB–FUBINACA ....................................................................................................................................................................................                     50
     AB–PINACA .........................................................................................................................................................................................                  30
     ADB-FUBINACA (N-(1-amino-3,3-dimethyl-1-oxobutan-2-yl)-1-(4-fluorobenzyl)-1H-indazole-3-carboxamide) ..................................                                                                              30
     Acetyl Fentanyl ....................................................................................................................................................................................                100
     Acetyl-alpha-methylfentanyl .................................................................................................................................................................                        30
     Acetyldihydrocodeine ...........................................................................................................................................................................                     30
     Acetylmethadol ....................................................................................................................................................................................                   2
     Acryl fentanyl .......................................................................................................................................................................................               25
     ADB–PINACA (N-(1-amino-3,3-dimethyl-1-oxobutan-2-yl)-1-pentyl-1H-indazole-3-carboxamide) .....................................................                                                                       50
     AH–7921 ..............................................................................................................................................................................................               30
     Allylprodine ..........................................................................................................................................................................................               2
     Alphacetylmethadol ..............................................................................................................................................................................                     2
     alpha-ethyltryptamine ...........................................................................................................................................................................                    25



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     63536                                 Federal Register / Vol. 83, No. 236 / Monday, December 10, 2018 / Notices

                                                                                                                                                                                                                 Final revised
                                                                                                Basic class                                                                                                      2018 quotas
                                                                                                                                                                                                                      (g)

     Alphameprodine ...................................................................................................................................................................................                     2
     Alphamethadol .....................................................................................................................................................................................                    2
     alpha-methylfentanyl ............................................................................................................................................................................                     30
     alpha-methylthiofentanyl ......................................................................................................................................................................                       30
     alpha-methyltryptamine (AMT) ............................................................................................................................................................                             25
     alpha-Pyrrolidinobutiophenone (α-PBP) ..............................................................................................................................................                                  25
     alpha-Pyrrolidinopentiophenone (α-PVP) ............................................................................................................................................                                   25
     Aminorex ..............................................................................................................................................................................................               25
     Anileridine ............................................................................................................................................................................................              20
     APINACA, AKB48 (N-(1-Adamantyl)-1-pentyl-1H-indazole-3-carboxamide) ......................................................................................                                                            25
     Benzylmorphine ...................................................................................................................................................................................                    30
     Betacetylmethadol ...............................................................................................................................................................................                      2
     beta-Hydroxy-3-methylfentanyl ............................................................................................................................................................                            30
     beta-Hydroxyfentanyl ...........................................................................................................................................................................                      30
     beta-Hydroxythiofentanyl .....................................................................................................................................................................                        30
     Betameprodine .....................................................................................................................................................................................                    2
     Betamethadol .......................................................................................................................................................................................                   4
     Betaprodine ..........................................................................................................................................................................................                 2
     Bufotenine ............................................................................................................................................................................................                3
     Butylone ...............................................................................................................................................................................................              25
     Butyryl fentanyl ....................................................................................................................................................................................                 30
     Cathinone .............................................................................................................................................................................................               24
     Codeine methylbromide .......................................................................................................................................................................                         30
     Codeine-N-oxide ..................................................................................................................................................................................                   192
     Desomorphine ......................................................................................................................................................................................                   25
     Diampromide ........................................................................................................................................................................................                  20
     Diethylthiambutene ..............................................................................................................................................................................                     20
     Diethyltryptamine .................................................................................................................................................................................                   25
     Difenoxin ..............................................................................................................................................................................................           8,225
     Dihydromorphine ..................................................................................................................................................................................             1,000,160
     Dimethyltryptamine ..............................................................................................................................................................................                     50
     Dipipanone ...........................................................................................................................................................................................                 5
     Etorphine ..............................................................................................................................................................................................              30
     Fenethylline ..........................................................................................................................................................................................               30
     Furanyl fentanyl ...................................................................................................................................................................................                  30
     Gamma-Hydroxybutyric Acid ...............................................................................................................................................................                     37,130,000
     Heroin ..................................................................................................................................................................................................             45
     Hydromorphinol ....................................................................................................................................................................................                   40
     Hydroxypethidine .................................................................................................................................................................................                     2
     Ibogaine ...............................................................................................................................................................................................              30
     JWH–018 and AM678 (1-Pentyl-3-(1-naphthoyl) indole) ....................................................................................................................                                              35
     JWH–019 (1-Hexyl-3-(1-naphthoyl)indole) ..........................................................................................................................................                                    45
     JWH–073 (1-Butyl-3-(1-naphthoyl)indole) ...........................................................................................................................................                                   45
     JWH–081 (1-Pentyl-3-(1-(4-methoxynaphthoyl)] indole) .....................................................................................................................                                            30
     JWH–122 (1-Pentyl-3-(4-methyl-1-naphthoyl) indole) .........................................................................................................................                                          30
     JWH–200 (1-[2-(4-Morpholinyl)ethyl]-3-(1-naphthoyl)indole) ..............................................................................................................                                             35
     JWH–203 (1-Pentyl-3-(2-chlorophenylacetyl) indole) ..........................................................................................................................                                         30
     JWH–250 (1-Pentyl-3-(2-methoxyphenylacetyl) indole) ......................................................................................................................                                            30
     JWH–398 (1-Pentyl-3-(4-chloro-1-naphthoyl) indole) ..........................................................................................................................                                         30
     Lysergic acid diethylamide (LSD) ........................................................................................................................................................                             40
     MAB–CHMINACA;                       ADB–CHMINACA                            (N-(1-amino-3,3dimethyl-1-oxobutan-2-yl)-1-(cyclohexylmethyl)-1H-indazole-3-
       carboxamide) ....................................................................................................................................................................................                    30
     MDMB–CHMICA; MMB–CHMINACA(Methyl 2-(1-(cyclohexylmethyl)-1H-indole-3-carboxamido)-3,3-dimethylbutanoate) ...............                                                                                               30
     MDMB–FUBINACA (methyl 2-(1-(4-fluorobenzyl)-1H-indazole-3-carboxamido)-3,3-dimethylbutanoate) ..........................................                                                                               30
     Marihuana ............................................................................................................................................................................................          1,140,216
     Mecloqualone .......................................................................................................................................................................................                   30
     Mescaline .............................................................................................................................................................................................                25
     Methaqualone ......................................................................................................................................................................................                    60
     Methcathinone .....................................................................................................................................................................................                    25
     Methyldesorphine .................................................................................................................................................................................                      5
     Methyldihydromorphine ........................................................................................................................................................................                          2
     Morphine methylbromide .....................................................................................................................................................................                            5
     Morphine methylsulfonate ....................................................................................................................................................................                           5
     Morphine-N-oxide ................................................................................................................................................................................                     150
     N,N-Dimethylamphetamine ..................................................................................................................................................................                             25
     Naphyrone ...........................................................................................................................................................................................                  25
     N-Ethyl-1-phenylcyclohexylamine ........................................................................................................................................................                                5
     N-Ethyl-3-piperidyl benzilate ................................................................................................................................................................                         10
     N-Ethylamphetamine ...........................................................................................................................................................................                         24
     N-Hydroxy-3,4-methylenedioxyamphetamine ......................................................................................................................................                                         24
     Noracymethadol ...................................................................................................................................................................................                      2
     Norlevorphanol .....................................................................................................................................................................................                   55



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                                           Federal Register / Vol. 83, No. 236 / Monday, December 10, 2018 / Notices                                                                                                    63537

                                                                                                                                                                                                                   Final revised
                                                                                                 Basic class                                                                                                       2018 quotas
                                                                                                                                                                                                                        (g)

     Normethadone .....................................................................................................................................................................................                       2
     Normorphine ........................................................................................................................................................................................                    40
     Para-fluorofentanyl ...............................................................................................................................................................................                     25
     Parahexyl .............................................................................................................................................................................................                  5
     PB–22; QUPIC .....................................................................................................................................................................................                      20
     Pentedrone ..........................................................................................................................................................................................                   25
     Pentylone .............................................................................................................................................................................................                 25
     Phenomorphan ....................................................................................................................................................................................                        2
     Pholcodine ...........................................................................................................................................................................................                   5
     Psilocybin .............................................................................................................................................................................................                30
     Psilocyn ................................................................................................................................................................................................               50
     SR–18 and RCS–8 (1-Cyclohexylethyl-3-(2-methoxyphenylacetyl)indole) .........................................................................................                                                           45
     SR–19 and RCS–4 (1-Pentyl-3-[(4-methoxy)-benzoyl]indole) ............................................................................................................                                                   30
     Tetrahydrocannabinols ........................................................................................................................................................................                     384,460
     Thiofentanyl .........................................................................................................................................................................................                  25
     THJ–2201 ([1-(5-fluoropentyl)-1H-indazol-3-yl](naphthalen-1-yl) methanone) ....................................................................................                                                         30
     Tilidine ..................................................................................................................................................................................................             25
     Trimeperidine .......................................................................................................................................................................................                    2
     UR–144 (1-Pentyl-1H-indol-3-yl)(2,2,3,3-tetramethylcyclopropyl) methanone ....................................................................................                                                          25
     U–47700 ..............................................................................................................................................................................................                  30

                                                                                                              Schedule II

     1-Phenylcyclohexylamine ....................................................................................................................................................................                            15
     1-Piperidinocyclohexanecarbonitrile ....................................................................................................................................................                                25
     4-Anilino-N-phenethyl-4-piperidine (ANPP) .........................................................................................................................................                              1,342,000
     Alfentanil ..............................................................................................................................................................................................            6,200
     Alphaprodine ........................................................................................................................................................................................                    2
     Amobarbital ..........................................................................................................................................................................................              20,100
     Amphetamine (for conversion) ............................................................................................................................................................                       12,000,000
     Amphetamine (for sale) .......................................................................................................................................................................                  39,856,000
     Carfentanil ............................................................................................................................................................................................                20
     Cocaine ................................................................................................................................................................................................            92,120
     Codeine (for conversion) .....................................................................................................................................................................                  13,536,000
     Codeine (for sale) ................................................................................................................................................................................             36,114,260
     Dextropropoxyphene ............................................................................................................................................................................                         35
     Dihydrocodeine ....................................................................................................................................................................................                264,140
     Dihydroetorphine ..................................................................................................................................................................................                      2
     Diphenoxylate (for conversion) ............................................................................................................................................................                         14,100
     Diphenoxylate (for sale) .......................................................................................................................................................................                   770,800
     Ecgonine ..............................................................................................................................................................................................             88,134
     Ethylmorphine ......................................................................................................................................................................................                    30
     Etorphine hydrochloride .......................................................................................................................................................................                         32
     Fentanyl ...............................................................................................................................................................................................         1,342,320
     Glutethimide .........................................................................................................................................................................................                   2
     Hydrocodone (for conversion) .............................................................................................................................................................                         114,680
     Hydrocodone (for sale) ........................................................................................................................................................................                 43,027,640
     Hydromorphone ...................................................................................................................................................................................                4,547,720
     Isomethadone ......................................................................................................................................................................................                     30
     Levo-alphacetylmethadol (LAAM) ........................................................................................................................................................                                  5
     Levomethorphan ..................................................................................................................................................................................                    2,200
     Levorphanol .........................................................................................................................................................................................               38,000
     Lisdexamfetamine ................................................................................................................................................................................               19,000,000
     Meperidine ...........................................................................................................................................................................................           1,913,148
     Meperidine Intermediate-A ..................................................................................................................................................................                            30
     Meperidine Intermediate-B ..................................................................................................................................................................                            30
     Meperidine Intermediate-C ..................................................................................................................................................................                            30
     Metazocine ...........................................................................................................................................................................................                  15
     Methadone (for sale) ...........................................................................................................................................................................                22,278,000
     Methadone Intermediate ......................................................................................................................................................................                   24,064,000
     Methamphetamine ...............................................................................................................................................................................                  1,446,754

       [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
     Morphine (for conversion) ....................................................................................................................................................................                   4,089,000
     Morphine (for sale) ..............................................................................................................................................................................              29,353,676
     Nabilone ...............................................................................................................................................................................................            62,000
     Noroxymorphone (for conversion) .......................................................................................................................................................                         17,804.670
     Noroxymorphone (for sale) ..................................................................................................................................................................                       376,000
     Opium (powder) ...................................................................................................................................................................................                  84,600



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     63538                                 Federal Register / Vol. 83, No. 236 / Monday, December 10, 2018 / Notices

                                                                                                                                                                                                                Final revised
                                                                                                Basic class                                                                                                     2018 quotas
                                                                                                                                                                                                                     (g)

     Opium (tincture) ...................................................................................................................................................................................            564,000
     Oripavine ..............................................................................................................................................................................................     26,629,500
     Oxycodone (for conversion) ................................................................................................................................................................                   2,453,400
     Oxycodone (for sale) ...........................................................................................................................................................................             79,596,606
     Oxymorphone (for conversion) ............................................................................................................................................................                    20,962,000
     Oxymorphone (for sale) .......................................................................................................................................................................                3,137,240
     Pentobarbital ........................................................................................................................................................................................       25,850,000
     Phenazocine ........................................................................................................................................................................................                  5
     Phencyclidine .......................................................................................................................................................................................                35
     Phenmetrazine .....................................................................................................................................................................................                  25
     Phenylacetone .....................................................................................................................................................................................                  40
     Racemethorphan .................................................................................................................................................................................                      5
     Racemorphan ......................................................................................................................................................................................                    5
     Remifentanil .........................................................................................................................................................................................            3,000
     Secobarbital .........................................................................................................................................................................................          172,100
     Sufentanil .............................................................................................................................................................................................          1,880
     Tapentadol ...........................................................................................................................................................................................       18,388,280
     Thebaine ..............................................................................................................................................................................................      84,600,000

                                                                                                         List I Chemicals

     Ephedrine (for conversion) ..................................................................................................................................................................                    47,000
     Ephedrine (for sale) .............................................................................................................................................................................            4,136,000
     Phenylpropanolamine (for conversion) ................................................................................................................................................                        14,100,000
     Phenylpropanolamine (for sale) ...........................................................................................................................................................                    7,990,000
     Pseudoephedrine (for conversion) ......................................................................................................................................................                           1,000
     Pseudoephedrine (for sale) .................................................................................................................................................................                180,000,000



       Aggregate production quotas for all                                       FOR FURTHER INFORMATION CONTACT:       If                                       respond, including use of appropriate
     other schedule I and II controlled                                          you have additional comments                                                    automated, electronic, mechanical, or
     substances included in 21 CFR 1308.11                                       especially on the estimated public                                              other technological collection
     and 1308.12 remain at zero.                                                 burden or associated response time,                                             techniques or other forms of
       Dated: December 3, 2018.                                                  suggestions, or need a copy of the                                              information technology, e.g.,
     Uttam Dhillon,
                                                                                 proposed information collection                                                 permitting electronic submission of
                                                                                 instrument with instructions or                                                 responses.
     Acting Administrator.
                                                                                 additional information, please contact                                          Overview of this information
     [FR Doc. 2018–26587 Filed 12–7–18; 8:45 am]
                                                                                 Benjamin Adams, Social Science                                               collection:
     BILLING CODE 4410–09–P                                                      Analyst, National Institute of Justice,                                         1. Type of Information Collection:
                                                                                 810 Seventh Street NW, Washington, DC                                        Extension, without change, of a
                                                                                 20531 (email: benjamin.adams@                                                currently approved collection.
     DEPARTMENT OF JUSTICE
                                                                                 usdoj.gov; telephone: 202–616–3687).                                            2. The Title of the Form/Collection:
     Office of Justice Programs                                                  SUPPLEMENTARY INFORMATION: Written                                           Census of Juveniles in Residential
                                                                                 comments and suggestions from the                                            Placement.
     [OMB Number 1121–0218]                                                      public and affected agencies concerning                                         3. The agency form number, if any,
     Agency Information Collection                                               the proposed collection of information                                       and the applicable component of the
     Activities; Proposed eCollection                                            are encouraged. Your comments should                                         Department sponsoring the collection:
     eComments Requested; Extension                                              address one or more of the following                                         The form number is CJ–14, Office of
     Without Change, of a Previously                                             four points:                                                                 Justice Programs, United States
     Approved Collection Census of                                               —Evaluate whether the proposed                                               Department of Justice.
                                                                                   collection of information is necessary                                        4. Affected public who will be asked
     Juveniles in Residential Placement
                                                                                   for the proper performance of the                                          or required to respond, as well as a brief
     (CJRP)
                                                                                   functions of the agency, including                                         abstract:
     AGENCY:  Office of Justice Programs,                                          whether the information shall have                                            Primary: Federal Government, State,
     Department of Justice.                                                        practical utility;                                                         Local or Tribal. Other: Not-for-profit
     ACTION: 60-Day notice.                                                      —Evaluate whether the accuracy of the                                        institutions; Business or other for-profit.
                                                                                   agency’s estimate of the burden on the                                     Abstract: The Census of Juveniles in
     SUMMARY:   The Department of Justice                                          proposed collection of information,                                        Residential Placement (CJRP), which is
     (DOJ), Office of Justice Programs, will be                                    including the validity of the                                              administered biennially, collects
     submitting the following information                                          methodology and assumptions that                                           information from all secure and
     collection request to the Office of                                           were used;                                                                 nonsecure residential placement
     Management and Budget (OMB) for                                             —Evaluate whether and if so how the                                          facilities that house juvenile offenders,
     review and approval in accordance with                                        quality, utility, and clarity of the                                       defined as persons younger than age 21
     the Paperwork Reduction Act of 1995.                                          information collected can be                                               who are held in a residential setting as
     DATES: Comments are encouraged and                                            enhanced; and                                                              a result of some contact with the justice
     will be accepted for 60 days until                                          —Minimize the burden of the collection                                       system. This encompasses both status
     February 8, 2019.                                                             of information on those who are to                                         offenses and delinquency offenses, and


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Document Created: 2018-12-08 00:21:48
Document Modified: 2018-12-08 00:21:48
CategoryRegulatory Information
CollectionFederal Register
sudoc ClassAE 2.7:
GS 4.107:
AE 2.106:
PublisherOffice of the Federal Register, National Archives and Records Administration
SectionNotices
ActionFinal order.
DatesThis order is effective December 10, 2018.
ContactRegulatory Drafting and Policy Support Section (DPW), Diversion Control Division, Drug Enforcement Administration, 8701 Morrissette Drive, Springfield, VA 22152, Telephone: (202) 598-6812.
FR Citation83 FR 63533 

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