83_FR_42325 83 FR 42164 - Proposed 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 2019

83 FR 42164 - Proposed 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 2019

DEPARTMENT OF JUSTICE
Drug Enforcement Administration

Federal Register Volume 83, Issue 161 (August 20, 2018)

Page Range42164-42169
FR Document2018-17893

The Drug Enforcement Administration (DEA) proposes to establish the 2019 aggregate production quotas for controlled substances in schedules I and II of the Controlled Substances Act and assessment of annual needs for the list I chemicals ephedrine, pseudoephedrine, and phenylpropanolamine.

Federal Register, Volume 83 Issue 161 (Monday, August 20, 2018) 
[Federal Register Volume 83, Number 161 (Monday, August 20, 2018)]
[Notices]
[Pages 42164-42169]
From the Federal Register Online  [www.thefederalregister.org]
[FR Doc No: 2018-17893]



[[Page 42164]]

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

DEPARTMENT OF JUSTICE

Drug Enforcement Administration

[Docket No. DEA-488P]


Proposed 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 2019

AGENCY: Drug Enforcement Administration, Department of Justice.

ACTION: Notice with request for comments.

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

SUMMARY: The Drug Enforcement Administration (DEA) proposes to 
establish the 2019 aggregate production quotas for controlled 
substances in schedules I and II of the Controlled Substances Act and 
assessment of annual needs for the list I chemicals ephedrine, 
pseudoephedrine, and phenylpropanolamine.

DATES: Interested persons may file written comments on this notice in 
accordance with 21 CFR 1303.11(c) and 1315.11(d). Electronic comments 
must be submitted, and written comments must be postmarked, on or 
before September 19, 2018. Commenters should be aware that the 
electronic Federal Docket Management System will not accept comments 
after 11:59 p.m. Eastern Time on the last day of the comment period.
    Based on comments received in response to this notice, the 
Administrator may hold a public hearing on one or more issues raised. 
In the event the Administrator decides in his sole discretion to hold 
such a hearing, the Administrator will publish a notice of any such 
hearing in the Federal Register. After consideration of any comments or 
objections, or after a hearing, if one is held, the Administrator will 
publish in the Federal Register a final order establishing the 2019 
aggregate production quotas for schedule I and II controlled 
substances, and an assessment of annual needs for the list I chemicals 
ephedrine, pseudoephedrine, and phenylpropanolamine.

ADDRESSES: To ensure proper handling of comments, please reference 
``Docket No. DEA-488P'' on all correspondence, including any 
attachments. The Drug Enforcement Administration encourages that all 
comments be submitted electronically through the Federal eRulemaking 
Portal, which provides the ability to type short comments directly into 
the comment field on the web page or attach a file for lengthier 
comments. Please go to http://www.regulations.gov and follow the online 
instructions at that site for submitting comments. Upon completion of 
your submission you will receive a Comment Tracking Number for your 
comment. Please be aware that submitted comments are not 
instantaneously available for public view on regulations.gov. If you 
have received a Comment Tracking Number, your comment has been 
successfully submitted and there is no need to resubmit the same 
comment. Paper comments that duplicate electronic submissions are not 
necessary and are discouraged. Should you wish to mail a paper comment 
in lieu of an electronic comment, it should be sent via regular or 
express mail to: Drug Enforcement Administration, Attention: DEA 
Federal Register Representative/DRW, 8701 Morrissette Drive, 
Springfield, Virginia 22152.

FOR FURTHER INFORMATION CONTACT: Thomas D. Sonnen, Diversion Control 
Division, Drug Enforcement Administration; Mailing Address: 8701 
Morrissette Drive, Springfield, Virginia 22152, Telephone: (202) 598-
6812.

SUPPLEMENTARY INFORMATION: 

Posting of Public Comments

    Please note that all comments received in response to this docket 
are considered part of the public record. They will, unless reasonable 
cause is given, be made available by the Drug Enforcement 
Administration (DEA) for public inspection online at http://www.regulations.gov. Such information includes personal identifying 
information (such as your name, address, etc.) voluntarily submitted by 
the commenter.
    The Freedom of Information Act (FOIA) applies to all comments 
received. If you want to submit personal identifying information (such 
as your name, address, etc.) as part of your comment, but do not want 
it to be made publicly available, you must include the phrase 
``PERSONAL IDENTIFYING INFORMATION'' in the first paragraph of your 
comment. You must also place all the personal identifying information 
you do not want made publicly available in the first paragraph of your 
comment and identify what information you want redacted.
    If you want to submit confidential business information as part of 
your comment, but do not want it to be made publicly available, you 
must include the phrase ``CONFIDENTIAL BUSINESS INFORMATION'' in the 
first paragraph of your comment. You must also prominently identify 
confidential business information to be redacted within the comment.
    Comments containing personal identifying information or 
confidential business information identified and located as directed 
above will generally be made available in redacted form. If a comment 
contains so much confidential business information or personal 
identifying information that it cannot be effectively redacted, all or 
part of that comment may not be made publicly available. Comments 
posted to http://www.regulations.gov may include any personal 
identifying information (such as name, address, and phone number) 
included in the text of your electronic submission that is not 
identified as directed above as confidential.
    An electronic copy of this document is available at http://www.regulations.gov for easy reference.

Legal Authority

    Section 306 of the Controlled Substances Act (CSA) (21 U.S.C. 826) 
requires the Attorney General to establish aggregate production quotas 
for each basic class of controlled substance listed in schedules I and 
II and for the list I chemicals ephedrine, pseudoephedrine, and 
phenylpropanolamine. The Attorney General has delegated this function 
to the Administrator of the DEA pursuant to 28 CFR 0.100.

Analysis for Proposed 2019 Aggregate Production Quotas and Assessment 
of Annual Needs

    The proposed year 2019 aggregate production quotas and assessment 
of annual needs represent those quantities of schedule I and II 
controlled substances, and the list I chemicals ephedrine, 
pseudoephedrine, and phenylpropanolamine, to be manufactured in the 
United States in 2019 to provide for the estimated medical, scientific, 
research, and industrial needs of the United States, lawful export 
requirements, and the establishment and maintenance of reserve stocks. 
These quotas include imports of ephedrine, pseudoephedrine, and 
phenylpropanolamine, but do not include imports of controlled 
substances for use in industrial processes.
    In determining the proposed 2019 aggregate production quotas and 
assessment of annual needs, the Acting Administrator has taken into 
account the criteria in 21 U.S.C. 826(a) and factors set forth in 21 
CFR 1303.11 (aggregate production quotas for controlled substances) and 
21 CFR 1315.11 (assessment of annual needs for ephedrine, 
pseudoephedrine, and

[[Page 42165]]

phenylpropanolamine). The DEA proposes the aggregate production quotas 
and assessment of annual needs for 2019 by considering: (1) Total net 
disposal of each class or chemical by all manufacturers and chemical 
importers during the current and two preceding years; (2) trends in the 
national rate of net disposal of the class or chemical; (3) total 
actual (or estimated) inventories of the class or chemical and of all 
substances manufactured from the class or chemical, and trends in 
inventory accumulation; (4) projected demand for each class or chemical 
as indicated by procurement and import quotas requested in accordance 
with 21 CFR 1303.12, 1315.32, and 1315.34; and (5) other factors 
affecting medical, scientific, research, and industrial needs of the 
United States and lawful export requirements, as the Acting 
Administrator finds relevant. These quotas do not include imports of 
controlled substances for use in industrial processes.
    Other factors the Acting Administrator considered in calculating 
the aggregate production quotas, but not the assessment of annual 
needs, include product development requirements of both bulk and 
finished dosage form manufacturers, and other pertinent information. In 
determining the proposed 2019 assessment of annual needs, the DEA used 
the calculation methodology previously described in the 2010 and 2011 
assessment of annual needs (74 FR 60294, Nov. 20, 2009, and 75 FR 
79407, Dec. 20, 2010, respectively).
    On July 16, 2018, DEA published a final rule regarding controlled 
substances quotas with an effective date of August 15, 2018 
(``Controlled Substances Quotas Final Rule''). 83 FR 32784. The 
Controlled Substances Quotas Final Rule added two factors for DEA to 
consider when setting aggregate production quotas and assessments of 
annual needs. These additional factors are: (1) The extent of any 
diversion of the controlled substance in the class; and (2) relevant 
information obtained from the Department of Health and Human Services, 
including from the Food and Drug Administration, the Centers for 
Disease Control and Prevention, and the Centers for Medicare and 
Medicaid Services, and relevant information obtained from the states. 
The proposed aggregate quotas for 2019 in this notice were determined 
with consideration of the factors in effect prior to the effective date 
of the Controlled Substances Quotas Final Rule.
    The Acting Administrator, therefore, proposes to establish the 2019 
aggregate production quotas for certain schedule I and II controlled 
substances and assessment of annual needs for the list I chemicals 
ephedrine, pseudoephedrine, and phenylpropanolamine, expressed in grams 
of anhydrous acid or base, as follows:

------------------------------------------------------------------------
                                                           Proposed 2019
                                                              quotas
                       Basic class                       ---------------
                                                                (g)
------------------------------------------------------------------------
                               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 (AM694)......              30
1-Benzylpiperazine......................................              25
1-Methyl-4-phenyl-4-propionoxypiperidine................              10
1-[1-(2-Thienyl)cyclohexyl]piperidine...................              15
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-                                 30
 methoxybenzyl)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-                                25
 methoxybenzyl)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-                                  30
 methoxybenzyl)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-              30
 T-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 (2-CB)..............              25
1-(4-Cyanobutyl)-N-(2-phenylpropan-2-yl)-1H-indazole-3-               25
 carboximide............................................
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

[[Page 42166]]

 
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)...
N-(1-Amino-3-methyl-1-oxobutan-2-yl)-1-(5-fluoropentyl)-              25
 1H-indazole-3-carboxamide..............................
1-(5-Fluoropentyl)-N-(2-phenylpropan-2-yl)-1H-                        25
 pyrrolo[2,3-b]pyridine-3carboximide....................
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-UR144, 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
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
APINCA, 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
Cyclopropyl Fentanyl....................................              20
Desomorphine............................................              25
Diapromide..............................................              20
Diethylthiambutene......................................              20
Diethyltryptamine.......................................              25
Difenoxin...............................................           8,225
Dihydromorphine.........................................         753,500
Dimethyltryptamine......................................              50
Dipipanone..............................................               5
Etorphine...............................................              30
Fenethylline............................................              30
Fentanyl related substances.............................              25
Furanyl fentanyl........................................              30
gamma-Hydroxybutyric acid...............................      33,417,000
Heroin..................................................              45
Hydromorphinol..........................................              40
Hydroxypethidine........................................               2
Ibogaine................................................              30

[[Page 42167]]

 
Isobutyryl Fentanyl.....................................              25
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-3,3-dimethyl-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)..................
Methyl-2-(1-(cyclohexylmethyl)-1H-indole-3-carboxamido)-              25
 3-methylbutanoate......................................
Marihuana...............................................       2,450,000
Mecloqualone............................................              30
Mescaline...............................................              25
Methaqualone............................................              60
Methcathinone...........................................              25
Methyldesorphine........................................               5
Methyldihydromorphine...................................               2
Morphine methylbromide..................................               5
Morphine methylsulfonate................................               5
Morphine-N-oxide........................................             150
Naphthalen-1-yl 1-(5-fluorpentyl)-1H-indole-3-                        25
 carboxylate............................................
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
Normethadone............................................               2
Normorphine.............................................              40
Ocfentanil..............................................              25
Para-fluorofentanyl.....................................              25
Para-flourobutyryl fentanyl.............................              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
Tetrahydrofuranyl fentanyl..............................               5
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
Valeryl fentanyl........................................              25
------------------------------------------------------------------------
                               Schedule II
------------------------------------------------------------------------
1-Phenylcyclohexylamine.................................              15
1-Piperidinocyclohexanecarbonitrile.....................              25
4-Anilino-N-phenethyl-4-piperidine (ANPP)...............       1,185,000
Alfentanil..............................................           6,200
Alphaprodine............................................               2
Amobarbital.............................................          20,100
Amphetamine (for conversion)............................      12,000,000
Amphetamine (for sale)..................................      42,400,000
Carfentanil.............................................              20

[[Page 42168]]

 
Cocaine.................................................          92,120
Codeine (for conversion)................................      13,536,000
Codeine (for sale)......................................      40,015,800
Dextropropoxyphene......................................              35
Dihydrocodeine..........................................         238,466
Dihydroetorphine........................................               2
Diphenoxylate (for conversion)..........................          14,100
Diphenoxylate (for sale)................................         770,800
Ecgonine................................................          88,134
Ethylmorphine...........................................              30
Etorphine hydrochloride.................................              32
Fentanyl................................................       1,185,000
Glutethimide............................................               2
Hydrocodone (for conversion)............................           5,000
Hydrocodone (for sale)..................................      44,710,000
Hydromorphone...........................................       4,071,000
Isomethadone............................................              30
Levo-alphacetylmethadol (LAAM)..........................               5
Levomethorphan..........................................           4,000
Levorphanol.............................................          34,000
Lisdexamfetamine........................................      19,000,000
Meperidine..............................................       1,580,000
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).....................................      31,456,000
Nabilone................................................          62,000
Noroxymorphone (for conversion).........................      19,169,340
Noroxymorphone (for sale)...............................         376,000
Opium (powder)..........................................          84,600
Opium (tincture)........................................         530,837
Oripavine...............................................      28,705,000
Oxycodone (for conversion)..............................       2,081,000
Oxycodone (for sale)....................................      85,578,000
Oxymorphone (for conversion)............................      24,525,540
Oxymorphone (for sale)..................................       2,880,000
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)..............................              25
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)..............................     174,246,000
------------------------------------------------------------------------


[[Page 42169]]

    The Acting Administrator further proposes that aggregate production 
quotas for all other schedule I and II controlled substances included 
in 21 CFR 1308.11 and 1308.12 remain at zero. In accordance with 21 CFR 
1303.13 and 21 CFR 1315.13, upon consideration of the relevant factors, 
the Acting Administrator may adjust the 2019 aggregate production 
quotas and assessment of annual needs as needed.

Conclusion

    After consideration of any comments or objections, or after a 
hearing, if one is held, the Acting Administrator will issue and 
publish in the Federal Register a final order establishing the 2019 
aggregate production quotas for controlled substances in schedules I 
and II and establishing an assessment of annual needs for the list I 
chemicals ephedrine, pseudoephedrine, and phenylpropanolamine, 21 CFR 
1303.11(c) and 1315.11(f).

    Dated: August 14, 2018.
Uttam Dhillon,
Acting Administrator.
[FR Doc. 2018-17893 Filed 8-17-18; 8:45 am]
 BILLING CODE 4410-09-P

42164 Federal Register / Vol. 83, No. 161 / Monday, August 20, 2018 / Notices DEPARTMENT OF JUSTICE or attach a file for lengthier comments. business information to be redacted Please go to http://www.regulations.gov within the comment. Drug Enforcement Administration and follow the online instructions at Comments containing personal [Docket No. DEA–488P] that site for submitting comments. Upon identifying information or confidential completion of your submission you will business information identified and Proposed Aggregate Production receive a Comment Tracking Number for located as directed above will generally Quotas for Schedule I and II Controlled your comment. Please be aware that be made available in redacted form. If a Substances and Assessment of submitted comments are not comment contains so much confidential Annual Needs for the List I Chemicals instantaneously available for public business information or personal Ephedrine, Pseudoephedrine, and view on regulations.gov. If you have identifying information that it cannot be Phenylpropanolamine for 2019 received a Comment Tracking Number, effectively redacted, all or part of that your comment has been successfully comment may not be made publicly AGENCY: Drug Enforcement submitted and there is no need to available. Comments posted to http:// Administration, Department of Justice. resubmit the same comment. Paper www.regulations.gov may include any ACTION: Notice with request for comments that duplicate electronic personal identifying information (such comments. submissions are not necessary and are as name, address, and phone number) discouraged. Should you wish to mail a included in the text of your electronic SUMMARY: The Drug Enforcement submission that is not identified as paper comment in lieu of an electronic Administration (DEA) proposes to directed above as confidential. comment, it should be sent via regular establish the 2019 aggregate production An electronic copy of this document or express mail to: Drug Enforcement quotas for controlled substances in is available at http:// Administration, Attention: DEA Federal schedules I and II of the Controlled www.regulations.gov for easy reference. Register Representative/DRW, 8701 Substances Act and assessment of Morrissette Drive, Springfield, Virginia Legal Authority annual needs for the list I chemicals 22152. ephedrine, pseudoephedrine, and Section 306 of the Controlled phenylpropanolamine. FOR FURTHER INFORMATION CONTACT: Substances Act (CSA) (21 U.S.C. 826) Thomas D. Sonnen, Diversion Control requires the Attorney General to DATES: Interested persons may file Division, Drug Enforcement establish aggregate production quotas written comments on this notice in Administration; Mailing Address: 8701 for each basic class of controlled accordance with 21 CFR 1303.11(c) and Morrissette Drive, Springfield, Virginia substance listed in schedules I and II 1315.11(d). Electronic comments must 22152, Telephone: (202) 598–6812. and for the list I chemicals ephedrine, be submitted, and written comments must be postmarked, on or before SUPPLEMENTARY INFORMATION: pseudoephedrine, and September 19, 2018. Commenters phenylpropanolamine. The Attorney Posting of Public Comments should be aware that the electronic General has delegated this function to Please note that all comments the Administrator of the DEA pursuant Federal Docket Management System received in response to this docket are will not accept comments after 11:59 to 28 CFR 0.100. considered part of the public record. p.m. Eastern Time on the last day of the They will, unless reasonable cause is Analysis for Proposed 2019 Aggregate comment period. given, be made available by the Drug Production Quotas and Assessment of Based on comments received in Annual Needs Enforcement Administration (DEA) for response to this notice, the The proposed year 2019 aggregate public inspection online at http:// Administrator may hold a public production quotas and assessment of www.regulations.gov. Such information hearing on one or more issues raised. In annual needs represent those quantities includes personal identifying the event the Administrator decides in of schedule I and II controlled information (such as your name, his sole discretion to hold such a substances, and the list I chemicals address, etc.) voluntarily submitted by hearing, the Administrator will publish ephedrine, pseudoephedrine, and the commenter. a notice of any such hearing in the The Freedom of Information Act phenylpropanolamine, to be Federal Register. After consideration of (FOIA) applies to all comments manufactured in the United States in any comments or objections, or after a received. If you want to submit personal 2019 to provide for the estimated hearing, if one is held, the identifying information (such as your medical, scientific, research, and Administrator will publish in the name, address, etc.) as part of your industrial needs of the United States, Federal Register a final order comment, but do not want it to be made lawful export requirements, and the establishing the 2019 aggregate publicly available, you must include the establishment and maintenance of production quotas for schedule I and II phrase ‘‘PERSONAL IDENTIFYING reserve stocks. These quotas include controlled substances, and an INFORMATION’’ in the first paragraph imports of ephedrine, pseudoephedrine, assessment of annual needs for the list of your comment. You must also place and phenylpropanolamine, but do not I chemicals ephedrine, all the personal identifying information include imports of controlled pseudoephedrine, and you do not want made publicly substances for use in industrial phenylpropanolamine. available in the first paragraph of your processes. ADDRESSES: To ensure proper handling comment and identify what information In determining the proposed 2019 of comments, please reference ‘‘Docket you want redacted. aggregate production quotas and No. DEA–488P’’ on all correspondence, If you want to submit confidential assessment of annual needs, the Acting daltland on DSKBBV9HB2PROD with NOTICES including any attachments. The Drug business information as part of your Administrator has taken into account Enforcement Administration encourages comment, but do not want it to be made the criteria in 21 U.S.C. 826(a) and that all comments be submitted publicly available, you must include the factors set forth in 21 CFR 1303.11 electronically through the Federal phrase ‘‘CONFIDENTIAL BUSINESS (aggregate production quotas for eRulemaking Portal, which provides the INFORMATION’’ in the first paragraph controlled substances) and 21 CFR ability to type short comments directly of your comment. You must also 1315.11 (assessment of annual needs for into the comment field on the web page prominently identify confidential ephedrine, pseudoephedrine, and VerDate Sep<11>2014 19:04 Aug 17, 2018 Jkt 244001 PO 00000 Frm 00065 Fmt 4703 Sfmt 4703 E:\FR\FM\20AUN1.SGM 20AUN1

Federal Register / Vol. 83, No. 161 / Monday, August 20, 2018 / Notices 42165 phenylpropanolamine). The DEA Other factors the Acting the controlled substance in the class; proposes the aggregate production Administrator considered in calculating and (2) relevant information obtained quotas and assessment of annual needs the aggregate production quotas, but not from the Department of Health and for 2019 by considering: (1) Total net the assessment of annual needs, include Human Services, including from the disposal of each class or chemical by all product development requirements of Food and Drug Administration, the manufacturers and chemical importers both bulk and finished dosage form Centers for Disease Control and during the current and two preceding manufacturers, and other pertinent Prevention, and the Centers for years; (2) trends in the national rate of information. In determining the Medicare and Medicaid Services, and net disposal of the class or chemical; (3) proposed 2019 assessment of annual relevant information obtained from the total actual (or estimated) inventories of needs, the DEA used the calculation states. The proposed aggregate quotas the class or chemical and of all methodology previously described in for 2019 in this notice were determined substances manufactured from the class the 2010 and 2011 assessment of annual with consideration of the factors in or chemical, and trends in inventory needs (74 FR 60294, Nov. 20, 2009, and effect prior to the effective date of the accumulation; (4) projected demand for 75 FR 79407, Dec. 20, 2010, Controlled Substances Quotas Final each class or chemical as indicated by respectively). Rule. procurement and import quotas On July 16, 2018, DEA published a requested in accordance with 21 CFR final rule regarding controlled The Acting Administrator, therefore, 1303.12, 1315.32, and 1315.34; and (5) substances quotas with an effective date proposes to establish the 2019 aggregate other factors affecting medical, of August 15, 2018 (‘‘Controlled production quotas for certain schedule I scientific, research, and industrial needs Substances Quotas Final Rule’’). 83 FR and II controlled substances and of the United States and lawful export 32784. The Controlled Substances assessment of annual needs for the list requirements, as the Acting Quotas Final Rule added two factors for I chemicals ephedrine, Administrator finds relevant. These DEA to consider when setting aggregate pseudoephedrine, and quotas do not include imports of production quotas and assessments of phenylpropanolamine, expressed in controlled substances for use in annual needs. These additional factors grams of anhydrous acid or base, as industrial processes. are: (1) The extent of any diversion of follows: Proposed 2019 quotas Basic class (g) 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 (AM694) ........................................................................................................................... 30 1-Benzylpiperazine .............................................................................................................................................................................. 25 1-Methyl-4-phenyl-4-propionoxypiperidine ........................................................................................................................................... 10 1-[1-(2-Thienyl)cyclohexyl]piperidine ................................................................................................................................................... 15 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 daltland on DSKBBV9HB2PROD with NOTICES 4-Bromo-2,5-dimethoxyamphetamine (DOB) ...................................................................................................................................... 30 4-Bromo-2,5-dimethoxyphenethylamine (2–CB) ................................................................................................................................. 25 1-(4-Cyanobutyl)-N-(2-phenylpropan-2-yl)-1H-indazole-3-carboximide ............................................................................................... 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 VerDate Sep<11>2014 19:04 Aug 17, 2018 Jkt 244001 PO 00000 Frm 00066 Fmt 4703 Sfmt 4703 E:\FR\FM\20AUN1.SGM 20AUN1

42166 Federal Register / Vol. 83, No. 161 / Monday, August 20, 2018 / Notices Proposed 2019 quotas Basic class (g) 4-Methylaminorex ................................................................................................................................................................................ 25 4-Methyl-N-methylcathinone (mephedrone) ........................................................................................................................................ 45 4-Methyl-a-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 N-(1-Amino-3-methyl-1-oxobutan-2-yl)-1-(5-fluoropentyl)-1H-indazole-3-carboxamide ...................................................................... 25 1-(5-Fluoropentyl)-N-(2-phenylpropan-2-yl)-1H-pyrrolo[2,3-b]pyridine-3carboximide .......................................................................... 25 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-UR144, 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 Alphameprodine ................................................................................................................................................................................... 2 Alphamethadol ..................................................................................................................................................................................... 2 alpha-Methylfentanyl ............................................................................................................................................................................ 30 alpha-Methylthiofentanyl ...................................................................................................................................................................... 30 alpha-Methyltryptamine (AMT) ............................................................................................................................................................ 25 alpha-Pyrrolidinobutiophenone (a-PBP) .............................................................................................................................................. 25 alpha-Pyrrolidinopentiophenone (a-PVP) ............................................................................................................................................ 25 Aminorex .............................................................................................................................................................................................. 25 Anileridine ............................................................................................................................................................................................ 20 APINCA, 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 Cyclopropyl Fentanyl ........................................................................................................................................................................... 20 Desomorphine ...................................................................................................................................................................................... 25 Diapromide ........................................................................................................................................................................................... 20 Diethylthiambutene .............................................................................................................................................................................. 20 Diethyltryptamine ................................................................................................................................................................................. 25 Difenoxin .............................................................................................................................................................................................. 8,225 Dihydromorphine .................................................................................................................................................................................. 753,500 Dimethyltryptamine .............................................................................................................................................................................. 50 Dipipanone ........................................................................................................................................................................................... 5 Etorphine .............................................................................................................................................................................................. 30 daltland on DSKBBV9HB2PROD with NOTICES Fenethylline .......................................................................................................................................................................................... 30 Fentanyl related substances ................................................................................................................................................................ 25 Furanyl fentanyl ................................................................................................................................................................................... 30 gamma-Hydroxybutyric acid ................................................................................................................................................................ 33,417,000 Heroin .................................................................................................................................................................................................. 45 Hydromorphinol .................................................................................................................................................................................... 40 Hydroxypethidine ................................................................................................................................................................................. 2 Ibogaine ............................................................................................................................................................................................... 30 VerDate Sep<11>2014 19:04 Aug 17, 2018 Jkt 244001 PO 00000 Frm 00067 Fmt 4703 Sfmt 4703 E:\FR\FM\20AUN1.SGM 20AUN1

Federal Register / Vol. 83, No. 161 / Monday, August 20, 2018 / Notices 42167 Proposed 2019 quotas Basic class (g) Isobutyryl Fentanyl ............................................................................................................................................................................... 25 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-3,3-dimethyl-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 Methyl-2-(1-(cyclohexylmethyl)-1H-indole-3-carboxamido)-3-methylbutanoate .................................................................................. 25 Marihuana ............................................................................................................................................................................................ 2,450,000 Mecloqualone ....................................................................................................................................................................................... 30 Mescaline ............................................................................................................................................................................................. 25 Methaqualone ...................................................................................................................................................................................... 60 Methcathinone ..................................................................................................................................................................................... 25 Methyldesorphine ................................................................................................................................................................................. 5 Methyldihydromorphine ........................................................................................................................................................................ 2 Morphine methylbromide ..................................................................................................................................................................... 5 Morphine methylsulfonate .................................................................................................................................................................... 5 Morphine-N-oxide ................................................................................................................................................................................ 150 Naphthalen-1-yl 1-(5-fluorpentyl)-1H-indole-3-carboxylate .................................................................................................................. 25 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 Normethadone ..................................................................................................................................................................................... 2 Normorphine ........................................................................................................................................................................................ 40 Ocfentanil ............................................................................................................................................................................................. 25 Para-fluorofentanyl ............................................................................................................................................................................... 25 Para-flourobutyryl fentanyl ................................................................................................................................................................... 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 Tetrahydrofuranyl fentanyl ................................................................................................................................................................... 5 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 Valeryl fentanyl .................................................................................................................................................................................... 25 Schedule II 1-Phenylcyclohexylamine .................................................................................................................................................................... 15 daltland on DSKBBV9HB2PROD with NOTICES 1-Piperidinocyclohexanecarbonitrile .................................................................................................................................................... 25 4-Anilino-N-phenethyl-4-piperidine (ANPP) ......................................................................................................................................... 1,185,000 Alfentanil .............................................................................................................................................................................................. 6,200 Alphaprodine ........................................................................................................................................................................................ 2 Amobarbital .......................................................................................................................................................................................... 20,100 Amphetamine (for conversion) ............................................................................................................................................................ 12,000,000 Amphetamine (for sale) ....................................................................................................................................................................... 42,400,000 Carfentanil ............................................................................................................................................................................................ 20 VerDate Sep<11>2014 19:04 Aug 17, 2018 Jkt 244001 PO 00000 Frm 00068 Fmt 4703 Sfmt 4703 E:\FR\FM\20AUN1.SGM 20AUN1

42168 Federal Register / Vol. 83, No. 161 / Monday, August 20, 2018 / Notices Proposed 2019 quotas Basic class (g) Cocaine ................................................................................................................................................................................................ 92,120 Codeine (for conversion) ..................................................................................................................................................................... 13,536,000 Codeine (for sale) ................................................................................................................................................................................ 40,015,800 Dextropropoxyphene ............................................................................................................................................................................ 35 Dihydrocodeine .................................................................................................................................................................................... 238,466 Dihydroetorphine .................................................................................................................................................................................. 2 Diphenoxylate (for conversion) ............................................................................................................................................................ 14,100 Diphenoxylate (for sale) ....................................................................................................................................................................... 770,800 Ecgonine .............................................................................................................................................................................................. 88,134 Ethylmorphine ...................................................................................................................................................................................... 30 Etorphine hydrochloride ....................................................................................................................................................................... 32 Fentanyl ............................................................................................................................................................................................... 1,185,000 Glutethimide ......................................................................................................................................................................................... 2 Hydrocodone (for conversion) ............................................................................................................................................................. 5,000 Hydrocodone (for sale) ........................................................................................................................................................................ 44,710,000 Hydromorphone ................................................................................................................................................................................... 4,071,000 Isomethadone ...................................................................................................................................................................................... 30 Levo-alphacetylmethadol (LAAM) ........................................................................................................................................................ 5 Levomethorphan .................................................................................................................................................................................. 4,000 Levorphanol ......................................................................................................................................................................................... 34,000 Lisdexamfetamine ................................................................................................................................................................................ 19,000,000 Meperidine ........................................................................................................................................................................................... 1,580,000 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) .............................................................................................................................................................................. 31,456,000 Nabilone ............................................................................................................................................................................................... 62,000 Noroxymorphone (for conversion) ....................................................................................................................................................... 19,169,340 Noroxymorphone (for sale) .................................................................................................................................................................. 376,000 Opium (powder) ................................................................................................................................................................................... 84,600 Opium (tincture) ................................................................................................................................................................................... 530,837 Oripavine .............................................................................................................................................................................................. 28,705,000 Oxycodone (for conversion) ................................................................................................................................................................ 2,081,000 Oxycodone (for sale) ........................................................................................................................................................................... 85,578,000 Oxymorphone (for conversion) ............................................................................................................................................................ 24,525,540 Oxymorphone (for sale) ....................................................................................................................................................................... 2,880,000 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) .................................................................................................................................................................. 25 Ephedrine (for sale) ............................................................................................................................................................................. 4,136,000 daltland on DSKBBV9HB2PROD with NOTICES Phenylpropanolamine (for conversion) ................................................................................................................................................ 14,100,000 Phenylpropanolamine (for sale) ........................................................................................................................................................... 7,990,000 Pseudoephedrine (for conversion) ...................................................................................................................................................... 1,000 Pseudoephedrine (for sale) ................................................................................................................................................................. 174,246,000 VerDate Sep<11>2014 19:04 Aug 17, 2018 Jkt 244001 PO 00000 Frm 00069 Fmt 4703 Sfmt 4703 E:\FR\FM\20AUN1.SGM 20AUN1

Federal Register / Vol. 83, No. 161 / Monday, August 20, 2018 / Notices 42169 The Acting Administrator further Office, 145 N Street NE, Washington, DC 6. An estimate of the total public proposes that aggregate production 20530 (202–514–6563). burden (in hours) associated with the quotas for all other schedule I and II SUPPLEMENTARY INFORMATION: Written collection: 1,350 total annual burden controlled substances included in 21 comments and suggestions from the hours (0.5 hours × 2700 respondents + CFR 1308.11 and 1308.12 remain at public and affected agencies concerning 1,350 total burden hours). zero. In accordance with 21 CFR the proposed collection of information If additional information is required 1303.13 and 21 CFR 1315.13, upon are encouraged. Your comments should contact: Melody Braswell, Department consideration of the relevant factors, the address one or more of the following Clearance Officer, United States Acting Administrator may adjust the four points: Department of Justice, Justice 2019 aggregate production quotas and —Evaluate whether the proposed Management Division, Policy and assessment of annual needs as needed. collection of information is necessary Planning Staff, Two Constitution for the proper performance of the Square, 145 N Street NE, Washington, Conclusion DC 20530. functions of the Bureau of Justice After consideration of any comments Statistics, including whether the Dated: August 14, 2018. or objections, or after a hearing, if one information will have practical utility; Melody Braswell, is held, the Acting Administrator will —Evaluate the accuracy of the agency’s Department Clearance Officer for PRA, U.S. issue and publish in the Federal estimate of the burden of the Department of Justice. Register a final order establishing the proposed collection of information, [FR Doc. 2018–17864 Filed 8–17–18; 8:45 am] 2019 aggregate production quotas for including the validity of the BILLING CODE 4410–AT–P controlled substances in schedules I and methodology and assumptions used; II and establishing an assessment of —Evaluate whether and if so how the annual needs for the list I chemicals quality, utility, and clarity of the DEPARTMENT OF JUSTICE ephedrine, pseudoephedrine, and information to be collected can be phenylpropanolamine, 21 CFR enhanced; and [OMB Number 1103–0093] 1303.11(c) and 1315.11(f). —Minimize the burden of the collection of information on those who are to Agency Information Collection Dated: August 14, 2018. Activities; Proposed eCollection Uttam Dhillon, respond, including through the use of appropriate automated, electronic, eComments Requested; Revision of a Acting Administrator. Previously Approved Collection; COPS mechanical, or other technological [FR Doc. 2018–17893 Filed 8–17–18; 8:45 am] collection techniques or other forms Extension Request Form BILLING CODE 4410–09–P of information technology, e.g., AGENCY: Community Oriented Policing permitting electronic submission of Services (COPS) Office, Department of responses. Justice. DEPARTMENT OF JUSTICE Overview of This Information ACTION: 60-Day notice. [OMB Number 1103–0093] Collection SUMMARY: The Department of Justice Agency Information Collection 1. Type of Information Collection: (DOJ), Community Oriented Policing Activities; Proposed eCollection Revision of a currently approved Services (COPS) Office, will be eComments Requested; Revision of a collection, with change; comments submitting the following information Previously Approved Collection; COPS requested. collection request to the Office of Extension Request Form 2. The Title of the Form/Collection: Management and Budget (OMB) for COPS Extension Request Form. review and approval in accordance with AGENCY: Community Oriented Policing 3. The agency form number, if any, Services (COPS) Office, Department of the Paperwork Reduction Act of 1995. and the applicable component of the Justice. DATES: Comments are encouraged and Department sponsoring the collection: ACTION: 60-Day notice. will be accepted for 60 days until None. U.S. Department of Justice, October 19, 2018. Community Oriented Policing Services SUMMARY: The Department of Justice (COPS) Office. FOR FURTHER INFORMATION CONTACT: If (DOJ), Community Oriented Policing 4. Affected public who will be asked you have additional comments Services (COPS) Office, will be or required to respond, as well as a brief especially on the estimated public submitting the following information abstract: Law enforcement agencies and burden or associated response time, collection request to the Office of other COPS grants recipients that have suggestions, or need a copy of the Management and Budget (OMB) for grants expiring within 90 days of the proposed information collection review and approval in accordance with date of the form/request. The extension instrument with instructions or the Paperwork Reduction Act of 1995. request form will allow recipients of additional information, please contact DATES: Comments are encouraged and COPS grants the opportunity to request Lashon M. Hilliard, Policy Analyst, will be accepted for 60 days until a ‘‘no-cost’’ time extension in order to Department of Justice, Community October 19, 2018. complete the federal funding period and Oriented Policing Services (COPS) FOR FURTHER INFORMATION CONTACT: If requirements for their grant/cooperative Office, 145 N Street NE, Washington, DC you have additional comments agreement award. Requesting and/or 20530 (202–514–6563). especially on the estimated public receiving a time extension will not SUPPLEMENTARY INFORMATION: Written burden or associated response time, provide additional funding. comments and suggestions from the daltland on DSKBBV9HB2PROD with NOTICES suggestions, or need a copy of the 5. An estimate of the total number of public and affected agencies concerning proposed information collection respondents and the amount of time the proposed collection of information instrument with instructions or estimated for an average respondent to are encouraged. Your comments should additional information, please contact respond: It is estimated that address one or more of the following Lashon M. Hilliard, Policy Analyst, approximately 2,700 respondents four points: Department of Justice, Community annually will complete the form within —Evaluate whether the proposed Oriented Policing Services (COPS) 30 minutes. collection of information is necessary VerDate Sep<11>2014 19:04 Aug 17, 2018 Jkt 244001 PO 00000 Frm 00070 Fmt 4703 Sfmt 4703 E:\FR\FM\20AUN1.SGM 20AUN1


Document Created: 2018-08-18 01:28:10
Document Modified: 2018-08-18 01:28:10
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
ActionNotice with request for comments.
DatesInterested persons may file written comments on this notice in accordance with 21 CFR 1303.11(c) and 1315.11(d). Electronic comments must be submitted, and written comments must be postmarked, on or before September 19, 2018. Commenters should be aware that the electronic Federal Docket Management System will not accept comments after 11:59 p.m. Eastern Time on the last day of the comment period.
ContactThomas D. Sonnen, Diversion Control
FR Citation83 FR 42164 
2025 Federal Register | Disclaimer | Privacy Policy
USC | CFR | eCFR