Proposed Adjustments to the Aggregate Production Quotas for Schedule I and II Controlled Substances and Assessment of Annual Needs for the List I Chemicals Ephedrine, Pseudoephedrine, and Phenylpropanolamine for 2020, 54414-54421 [2020-19308]

Agencies

• Drug Enforcement Administration
• Department of Justice

[Federal Register Volume 85, Number 170 (Tuesday, September 1, 2020)]
[Notices]
[Pages 54414-54421]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2020-19308]


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

DEPARTMENT OF JUSTICE

Drug Enforcement Administration

[Docket No. DEA-508A2]


Proposed Adjustments to the Aggregate Production Quotas for 
Schedule I and II Controlled Substances and Assessment of Annual Needs 
for the List I Chemicals Ephedrine, Pseudoephedrine, and 
Phenylpropanolamine for 2020

AGENCY: Drug Enforcement Administration, Department of Justice.

ACTION: Notice with request for comments.

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

SUMMARY: The Drug Enforcement Administration proposes to adjust the 
2020 aggregate production quotas for several controlled substances in 
schedules I and II of the Controlled Substances Act and assessment of 
annual needs for the list I chemicals ephedrine, pseudoephedrine, and 
phenylpropanolamine.

DATES: Interested persons may file written comments on this notice in 
accordance with 21 CFR 1303.13(c) and 1315.13(d). Electronic comments 
must be submitted, and written comments must be postmarked, on or 
before October 1, 2020. 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 2020 
adjusted aggregate production quotas for schedule I and II controlled 
substances, and an adjusted 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-508A2'' on all correspondence, including any 
attachments. DEA 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 to attach a file for lengthier comments. Please go to 
https://www.regulations.gov and follow the online instructions at that 
site for submitting comments. Upon completion of your submission, you 
will receive a Comment Tracking Number for your comment. Please be 
aware that submitted comments are not instantaneously available for 
public view on Regulations.gov. If you have received a Comment Tracking 
Number, your comment has been successfully submitted and there is no 
need to resubmit the same comment. Paper comments that duplicate 
electronic submissions are not necessary and are discouraged. Should 
you wish to mail a paper comment in lieu of an electronic comment, it 
should be sent via regular or express mail to: Drug Enforcement 
Administration, Attention: DEA Federal Register Representative/DRW, 
8701 Morrissette Drive, Springfield, Virginia 22152.

FOR FURTHER INFORMATION CONTACT: Scott A. Brinks, Regulatory Drafting 
and Policy Support Section, Diversion Control Division, Drug 
Enforcement Administration; Mailing Address: 8701 Morrissette Drive, 
Springfield, Virginia 22152, Telephone: (571) 362-3261.

SUPPLEMENTARY INFORMATION:

Posting of Public Comments

    Please note that all comments received in response to this docket 
are considered part of the public record. They will, unless reasonable 
cause is given, be made available by the Drug Enforcement 
Administration (DEA) for public inspection online at https://www.regulations.gov. Such information includes personal identifying 
information (such as your name, address, etc.) voluntarily submitted by 
the commenter.
    The Freedom of Information Act 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

[[Page 54415]]

comment and identify what information you want redacted.
    If you want to submit confidential business information as part of 
your comment, but do not want it to be made publicly available, you 
must include the phrase ``CONFIDENTIAL BUSINESS INFORMATION'' in the 
first paragraph of your comment. You must also prominently identify 
confidential business information to be redacted within the comment.
    Comments containing personal identifying information or 
confidential business information identified and located as directed 
above will generally be made available in redacted form. If a comment 
contains so much confidential business information or personal 
identifying information that it cannot be effectively redacted, all or 
part of that comment may not be made publicly available. Comments 
posted to https://www.regulations.gov may include any personal 
identifying information (such as name, address, and phone number) 
included in the text of your electronic submission that is not 
identified as directed above as confidential.
    An electronic copy of this document is available at https://www.regulations.gov for easy reference.

Legal Authority and Background

    Section 306 of the Controlled Substances Act (CSA) (21 U.S.C. 826) 
requires the Attorney General to establish aggregate production quotas 
for each basic class of controlled substances listed in schedules I and 
II and for the list I chemicals ephedrine, pseudoephedrine, and 
phenylpropanolamine. The Attorney General has delegated this function 
to the Administrator of the DEA pursuant to 28 CFR 0.100.
    DEA established the 2020 aggregate production quotas for substances 
in schedules I and II and the assessment of annual needs for the list I 
chemicals ephedrine, pseudoephedrine, and phenylpropanolamine on 
December 2, 2019 (84 FR 66014). That order stipulated that, in 
accordance with 21 CFR 1303.13 and 1315.13, all aggregate production 
quotas and assessments of annual need are subject to adjustment. DEA 
issued a notice and final order on April 10, 2020, to adjust the 2020 
aggregate production quota for certain schedule II controlled 
substances and the assessment of annual needs for ephedrine and 
pseudoephedrine (85 FR 20302) in response to the coronavirus disease 
2019 public health emergency.

Analysis for Proposed Adjusted 2020 Aggregate Production Quotas and 
Assessment of Annual Needs

    DEA proposes to adjust the established 2020 aggregate production 
quotas and assessment of annual needs for certain schedule I and II 
controlled substances, and the list I chemicals ephedrine, 
pseudoephedrine, and phenylpropanolamine, to be manufactured in the 
United States in 2020 to provide for the estimated medical, scientific, 
research, and industrial needs of the United States, for lawful export 
requirements, and for the establishment and maintenance of reserve 
stocks. These quotas do not include imports of controlled substances 
for use in industrial processes.

Factors for Determining the Proposed Adjustments

    In determining the proposed adjustment, the Acting Administrator 
has taken into account the criteria in accordance with 21 CFR 1303.13 
(adjustment of aggregate production quotas for controlled substances) 
and 21 CFR 1315.13 (adjustment of the assessment of annual needs for 
ephedrine, pseudoephedrine, and phenylpropanolamine). The Acting 
Administrator is authorized to increase or reduce the aggregate 
production quota at any time. 21 CFR 1303.13(a) and 1315.13(a). DEA 
regulations state that there are five factors that shall be considered 
in determining to adjust the aggregate production quota and the 
assessment of annual needs. 21 CFR 1303.13(b) and 1315.13(b).
    DEA determined whether to propose an adjustment of the aggregate 
production quotas and assessment of annual needs for 2020 by 
considering: (1) Changes in the demand for that class or chemical, 
changes in the national rate of net disposal of the class or chemical, 
changes in the national rate of net disposal of the class or chemical 
by registrants holding individual manufacturing quotas for that class 
or chemical or import quotas for that chemical, and changes in the 
extent of any diversion in the class of controlled substance; (2) 
whether any increased demand for that class or chemical, the national 
and/or individual rates of net disposal of that class or chemical are 
temporary, short term, or long term; (3) whether any increased demand 
for that class or chemical can be met through existing inventories, 
increased individual manufacturing quotas, or increased importation, 
without increasing the aggregate production quota or assessment of 
annual needs, taking into account production delays and the probability 
that other individual manufacturing quotas may be suspended pursuant to 
Sections 1303.24(b) and 1315.24(b); (4) whether any decreased demand 
for that class or chemical will result in excessive inventory 
accumulation by all persons registered to handle that class or chemical 
(including manufacturers, distributors, practitioners, importers, and 
exporters), notwithstanding the possibility that individual 
manufacturing quotas may be suspended pursuant to Sections 1303.24(b) 
and 1315.24(b) or abandoned pursuant to Sections 1303.27 and 1315.27; 
and (5) other factors affecting medical, and reserve stocks, 
scientific, research, and industrial needs in the United States, lawful 
export requirements, and other factors affecting importation needs of 
listed chemicals in the United States as the Acting Administrator finds 
relevant, including changes in the currently accepted medical use in 
treatment with the class or chemical or the substances which are 
manufactured from it, the economic and physical availability of raw 
materials for use in manufacturing and for inventory purposes, yield 
and stability problems, potential disruptions to production (including 
possible labor strikes), and recent unforeseen emergencies such as 
floods and fires. 21 CFR 1303.13(b) and 1315(b). These quotas do not 
include imports of controlled substances for use in industrial 
processes.
    DEA considered the change in the extent of diversion of all 
controlled substances in proposing adjustments to the aggregate 
production quotas as required by 21 CFR 1303.13(b)(1). Through these 
considerations, it has been determined that any calculated changes from 
the previously determined initial calculations are slight and 
statistically indistinguishable from the quantities originally 
calculated for the extent of diversion that were applied to the initial 
aggregate production quota valuations.
    DEA also considered updated information obtained from 2019 year-end 
inventories, 2019 disposition data submitted by quota applicants, 
estimates of the medical needs of the United States, product 
development, and other information made available to DEA after the 
initial aggregate production quotas and assessment of annual needs had 
been established. Other factors the Acting Administrator considered in 
calculating the aggregate production quotas, but not the assessment of 
annual needs, include product development requirements of both bulk and 
finished dosage form

[[Page 54416]]

manufacturers, and other pertinent information. In determining the 
proposed adjusted 2020 assessment of annual needs, 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).

Considerations Based Upon the Substance Use-Disorder Prevention That 
Promotes Opioid Recovery and Treatment for Patients and Communities Act

    Pursuant to 21 U.S.C. 826(a)(1), ``production quotas shall be 
established in terms of quantities of each basic class of controlled 
substance and not in terms of individual pharmaceutical dosage forms 
prepared from or containing such a controlled substance.'' However, the 
Substance Use-Disorder Prevention that Promotes Opioid Recovery and 
Treatment for Patients and Communities Act of 2018 (SUPPORT Act), Pub. 
L. 115-271, provides an exception to that general rule by now giving 
DEA the authority to establish quotas in terms of pharmaceutical dosage 
forms if the agency determines that doing so will assist in avoiding 
the overproduction, shortages, or diversion of a controlled substance.
    DEA has stated before that while there is the authority to set 
aggregate production quotas in terms of pharmaceutical dosage form, DEA 
will not be using that authority at this time. Furthermore, when DEA 
does utilize the authority, it will be doing so at the individual 
dosage-form manufacturing level, as that is where it is most 
appropriate to do so. As such, there are no adjustments to set any 
controlled substances in terms of pharmaceutical dosage forms.
    Under the SUPPORT Act, when setting the aggregate production quota, 
DEA must estimate the amount of diversion of any substance that is 
considered a ``covered controlled substance,'' as defined by the 
SUPPORT Act. 21 U.S.C. 826(i)(1)(A). The covered controlled substances 
are fentanyl, oxycodone, hydrocodone, oxymorphone, and hydromorphone. 
The SUPPORT Act also requires DEA to ``make appropriate quota 
reductions, as determined by the [Administrator],\1\ from the quota the 
[Administrator] would have otherwise established had such diversion not 
been considered.'' 21 U.S.C. 826(i)(1)(C). When estimating diversion, 
the ``[Administrator] (i) shall consider information the 
[Administrator], in consultation with the Secretary of Health and Human 
Services, determines reliable on rates of overdose deaths and abuse and 
overall public health impact related to the covered controlled 
substance in the United States; and (ii) may take into consideration 
whatever other sources of information the [Administrator] determines 
reliable.'' \2\ Id.
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    \1\ All functions vested in the Attorney General by the CSA have 
been delegated to the Administrator of DEA. 28 CFR 0.100(b).
    \2\ DEA intends to finalize amendments to the Agency's 
regulations that will implement the amendments to the CSA made by 
the SUPPORT Act. Although these amendments to the regulations have 
not yet been issued, the statutory requirements stated above became 
effective upon enactment of the SUPPORT Act, and DEA is therefore 
obligated to adhere to them in issuing these adjusted aggregate 
production quotas.
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    DEA consulted with the U.S. Department of Health and Human Services 
(HHS) and DEA was advised that the Centers for Disease Control and 
Prevention (CDC) may have data that can provide reliable rates of 
overdose deaths. CDC provided DEA with data from their National Vital 
Statistics System-Mortality files. CDC determined that the current 
available data, calendar year 2016, regarding rates of overdose deaths 
and public health impact does not reflect each controlled substance 
individually (i.e., as a basic class and the quantity ingested), but 
groups them together functionally (opioid or psychostimulant), without 
regard to illicit or licit manufacturing. Without specificity to basic 
class and whether the substance was lawfully manufactured, DEA is 
unable to determine the basic class that led to the overdose from this 
information. DEA cannot determine from the data if the patient 
overdosed on an illicit opioid or a U.S. Food and Drug Administration-
approved opioid product. Nor can DEA determine if the overdose was a 
result of accidental or intentional ingestion. As such, the number of 
overdose deaths resulting from fentanyl, oxycodone, hydrocodone, 
hydromorphone, and oxymorphone diverted from legitimate sources is 
unknown. The overdose deaths provided by CDC in its current form cannot 
be reliably utilized to estimate the amount of diversion for the five 
covered controlled substances in 2020.
    In further consultation with HHS, DEA was advised that the Centers 
for Medicare and Medicaid Services (CMS) may have reliable rates of 
overprescribing. DEA was informed by CMS that CMS had reviewed their 
internal databases and does not have the ability to systematically 
distinguish between appropriate and inappropriate prescriptions without 
investigations.
    To update the estimates of diversion, DEA used data from the Drug 
Theft and Loss Report, Statistical Management Analysis & Reporting 
Tools System, and System to Retrieve Information on Drug Evidence 
databases to aggregate the active pharmaceutical ingredient (API) of 
each covered controlled substance by metric weight. From the databases, 
DEA gathered data involving employee theft, break-ins, armed robberies, 
and material lost in transit. DEA also used seizure data obtained from 
submitted reports by law enforcement agencies nationwide. This data was 
categorized by basic drug class and the amount of API in the dosage 
form was delineated with an appropriate metric for use in proposing the 
adjusted aggregate production quota values. Using the data, DEA 
calculated the estimates for the amount of diversion by multiplying the 
strength of the API listed for each finished dosage form by the total 
amount of units reported to estimate the metric weight in kilograms of 
the controlled substance being diverted. In DEA's previous adjustment 
for 2020, the diversion estimates were listed for fentanyl, 
hydromorphone, and oxymorphone, as those were the only covered 
controlled substances being adjusted. (April 10, 2020, 85 FR 20302.) 
Below, DEA has updated the chart to include estimations of diversion 
for each of the other covered controlled substances that will have 
proposed adjustments from what was established.

------------------------------------------------------------------------
 
------------------------------------------------------------------------
                    Diversion Estimates for 2019 (kg)
------------------------------------------------------------------------
Fentanyl.....................................................      0.090
Hydrocodone..................................................     30.294
Hydromorphone................................................      1.424
Oxycodone....................................................     60.959
Oxymorphone..................................................      1.311
------------------------------------------------------------------------

Proposed Adjustments for the 2020 Aggregate Production Quotas and 
Assessment of Annual Needs

    The Acting Administrator, therefore, proposes to adjust the 2020 
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:

[[Page 54417]]



----------------------------------------------------------------------------------------------------------------
                                                              Established
                        Basic class                           2020 quotas     Proposed revised 2020 quotas (g)
                                                                  (g)
----------------------------------------------------------------------------------------------------------------
                                              Temporarily Scheduled
----------------------------------------------------------------------------------------------------------------
Etoxeridine...............................................             N/A  25
FUB-AMB, MMB-FUBINACA, AMB-FUBINACA.......................             N/A  25
Norfentanyl...............................................             N/A  25
----------------------------------------------------------------------------------------------------------------
                                                   Schedule I
----------------------------------------------------------------------------------------------------------------
1-[1-(2-Thienyl)cyclohexyl]pyrrolidine....................              20  no change
1-(1-Phenylcyclohexyl)pyrrolidine.........................              15  no change
1-(2-Phenylethyl)-4-phenyl-4-acetoxypiperidine............              10  no change
1-(5-Fluoropentyl)-3-(1-naphthoyl)indole (AM2201).........              30  no change
1-(5-Fluoropentyl)-3-(2-iodobenzoyl)indole (AM694)........              30  no change
1-Benzylpiperazine........................................              25  no change
1-Methyl-4-phenyl-4-propionoxypiperidine..................              10  no change
1-[1-(2-Thienyl)cyclohexyl]piperidine.....................              15  no change
2-(2,5-Dimethoxy-4-ethylphenyl)ethanamine (2C-E)..........              30  no change
2-(2,5-Dimethoxy-4-methylphenyl)ethanamine (2C-D).........              30  no change
2-(2,5-Dimethoxy-4-nitro-phenyl)ethanamine (2C-N).........              30  no change
2-(2,5-Dimethoxy-4-n-propylphenyl)ethanamine (2C-P).......              30  no change
2-(2,5-Dimethoxyphenyl)ethanamine (2C-H)..................             100  no change
2-(4-Bromo-2,5-dimethoxyphenyl)-N-(2-                                   30  no change
 methoxybenzyl)ethanamine (25B-NBOMe; 2C-B-NBOMe; 25B;
 Cimbi-36).
2-(4-Chloro-2,5-dimethoxyphenyl)ethanamine (2C-C).........              30  no change
2-(4-Chloro-2,5-dimethoxyphenyl)-N-(2-                                  25  no change
 methoxybenzyl)ethanamine (25C-NBOMe; 2C-C-NBOMe; 25C;
 Cimbi-82).
2-(4-Iodo-2,5-dimethoxyphenyl)ethanamine (2C-I)...........              30  no change
2-(4-Iodo-2,5-dimethoxyphenyl)-N-(2-                                    30  no change
 methoxybenzyl)ethanamine (25I-NBOMe; 2C-I-NBOMe; 25I;
 Cimbi-5).
2,5-Dimethoxy-4-ethylamphetamine (DOET)...................              25  no change
2,5-Dimethoxy-4-n-propylthiophenethylamine................              25  no change
2,5-Dimethoxyamphetamine (DMA)............................              25  no change
2-[4-(Ethylthio)-2,5-dimethoxyphenyl]ethanamine (2C-T-2)..              30  no change
2-[4-(Isopropylthio)-2,5-dimethoxyphenyl]ethanamine (2C-T-              30  no change
 4).
3,4,5-Trimethoxyamphetamine...............................              30  no change
3,4-Methylenedioxyamphetamine (MDA).......................              55  no change
3,4-Methylenedioxymethamphetamine (MDMA)..................              50  no change
3,4-Methylenedioxy-N-ethylamphetamine (MDEA)..............              40  no change
3,4-Methylenedioxy-N-methylcathinone (methylone)..........              40  no change
3,4-Methylenedioxypyrovalerone (MDPV).....................              35  no change
3-Fluoro-N-methylcathinone (3-FMC)........................              25  no change
3-Methylfentanyl..........................................              30  no change
3-Methylthiofentanyl......................................              30  no change
4-Bromo-2,5-dimethoxyamphetamine (DOB)....................              30  no change
4-Bromo-2,5-dimethoxyphenethylamine (2-CB)................              25  no change
4-Chloro-alpha-pyrrolidinovalerophenone (4-chloro-alpha-                25  no change
 PVP).
4CN-Cumyl-Butinaca, 1-(4-Cyanobutyl)-N-(2-phenylpropan-2-               25  no change
 yl)-1H-indazole-3-carboximide.
4-Fluoroisobutyryl fentanyl...............................              30  no change
4-Fluoro-N-methylcathinone (4-FMC; Flephedrone)...........              25  no change
4-Methyl-N-ethylcathinone (4-MEC).........................              25  no change
4-Methoxyamphetamine......................................             150  no change
4-Methyl-2,5-dimethoxyamphetamine (DOM)...................              25  no change
4-Methylaminorex..........................................              25  no change
4-Methyl-N-methylcathinone (mephedrone)...................              45  no change
4-Methyl-alpha-ethylaminopentiophenone (4-MEAP)...........              25  no change
4-Methyl-alpha-pyrrolidinohexiophenone (MPHP).............              25  no change
4-Methyl-alpha-pyrrolidinopropiophenone (4-MePPP).........              25  no change
5-(1,1-Dimethylheptyl)-2-[(1R,3S)-3-hydroxycyclohexyl]-                 50  no change
 phenol.
5-(1,1-Dimethyloctyl)-2-[(1R,3S)-3-hydroxycyclohexyl]-                  40  no change
 phenol (cannabicyclohexanol or CP-47,497 C8-homolog).
5F-CUMYL-PINACA...........................................              25  no change
5F-EDMB-PINACA............................................              25  no change
5F-MDMB-PICA..............................................              25  no change
5F-AB-PINACA; N-(1-amino-3-methyl-1-oxobutan-2-yl)-1-(5-                25  no change
 fluoropentyl)-1H-indazole-3-carboxamide.
5F-CUMYL-P7AICA; (1-(5-fluoropentyl)-N-(2-phenylpropan-2-               25  no change
 yl)-1H-pyrrolo[2,3-b]pyridine-3-carboximide).
5F-ADB; 5F-MDMB-PINACA (methyl 2-(1-(5-fluoropentyl)-1H-                30  no change
 indazole-3-carboxamido)-3,3-dimethylbutanoate).
5F-AMB (methyl 2-(1-(5-fluoropentyl)-1H-indazole-3-                     30  no change
 carboxamido)-3-methylbutanoate).
5F-APINACA; 5F-AKB48 (N-(adamantan-1-yl)-1-(5-                          30  no change
 fluoropentyl)-1H-indazole-3-carboxamide).
5-Fluoro-PB-22; 5F-PB-22..................................              20  no change
5-Fluoro-UR144, XLR11 ([1-(5-fluoro-pentyl)-1H-indol-3-                 25  no change
 yl](2,2,3,3-tetramethylcyclopropyl)methanone.
5-Methoxy-3,4-methylenedioxyamphetamine...................              25  no change
5-Methoxy-N,N-diisopropyltryptamine.......................              25  no change
5-Methoxy-N,N-dimethyltryptamine..........................              25  no change

[[Page 54418]]

 
AB-CHMINACA...............................................              30  no change
AB-FUBINACA...............................................              50  no change
AB-PINACA.................................................              30  no change
ADB-FUBINACA (N-(1-amino-3,3-dimethyl-1-oxobutan-2-yl)-1-               30  no change
 (4-fluorobenzyl)-1H-indazole-3-carboxamide).
Acetorphine...............................................              25  no change
Acetyl Fentanyl...........................................             100  no change
Acetyl-alpha-methylfentanyl...............................              30  no change
Acetyldihydrocodeine......................................              30  no change
Acetylmethadol............................................              25  no change
Acryl Fentanyl............................................              25  no change
ADB-PINACA (N-(1-amino-3,3-dimethyl-1-oxobutan-2-yl)-1-                 50  no change
 pentyl-1H-indazole-3-carboxamide).
AH-7921...................................................              30  no change
Allylprodine..............................................              25  no change
Alphacetylmethadol........................................               2  25
Alpha-Ethyltryptamine.....................................              25  no change
Alphameprodine............................................               2  25
Alphamethadol.............................................               2  25
Alphaprodine..............................................              25  no change
Alpha-Methylfentanyl......................................              30  no change
Alpha-Methylthiofentanyl..................................              30  no change
Alpha-Methyltryptamine (AMT)..............................              25  no change
Alpha-Pyrrolidinobutiophenone ([alpha]-PBP)...............              25  no change
Alpha-Pyrrolidinoheptaphenone (PV8).......................              25  no change
Alpha-Pyrrolidinohexanophenone ([alpha]-PHP)..............              25  no change
Alpha-Pyrrolidinopentiophenone ([alpha]-PVP)..............              25  no change
Aminorex..................................................              25  no change
Anileridine...............................................              20  no change
APINACA, AKB48 (N-(1-adamantyl)-1-pentyl-1H-indazole-3-                 25  no change
 carboxamide).
Benzethidine..............................................              25  no change
Benzylmorphine............................................              30  no change
Betacetylmethadol.........................................               2  25
Beta-Hydroxy-3-methylfentanyl.............................              30  no change
Beta-Hydroxyfentanyl......................................              30  no change
Beta-Hydroxythiofentanyl..................................              30  no change
Betameprodine.............................................              25  no change
Betamethadol..............................................               4  no change
Betaprodine...............................................              25  no change
Bufotenine................................................              15  no change
Butylone..................................................              25  no change
Butyryl fentanyl..........................................              30  no change
Cathinone.................................................              40  no change
Clonitazene...............................................              25  no change
Codeine methylbromide.....................................              30  no change
Codeine-N-oxide...........................................             192  no change
Cyclopentyl Fentanyl......................................              30  no change
Cyclopropyl Fentanyl......................................              20  no change
Cyprenorphine.............................................              25  no change
Desomorphine..............................................              25  no change
Dextromoramide............................................              25  no change
Diapromide................................................              20  no change
Diethylthiambutene........................................              20  no change
Diethyltryptamine.........................................              25  no change
Difenoxin.................................................           9,200  no change
Dihydromorphine...........................................         753,500  no change
Dimenoxadol...............................................              25  no change
Dimepheptanol.............................................              25  no change
Dimethylthiambutene.......................................              20  no change
Dimethyltryptamine........................................              50  no change
Dioxyaphetyl butyrate.....................................              25  no change
Dipipanone................................................               5  25
Drotebanol................................................              25  no change
Ethylmethylthiambutene....................................              25  no change
Etorphine.................................................              30  no change
Fenethylline..............................................              30  no change
Fentanyl related substances...............................              40  600
FUB-144...................................................              25  no change
FUB-AKB48.................................................              25  no change
Furanyl fentanyl..........................................              30  no change
Furethidine...............................................              25  no change
Gamma-Hydroxybutyric Acid.................................      25,417,000  29,417,000
Heroin....................................................              45  no change

[[Page 54419]]

 
Hydromorphinol............................................              40  no change
Hydroxypethidine..........................................              25  no change
Ibogaine..................................................              30  no change
Isobutyryl Fentanyl.......................................              25  no change
JWH-018 and AM678 (1-Pentyl-3-(1-naphthoyl)indole)........              35  no change
JWH-019 (1-Hexyl-3-(1-naphthoyl)indole)...................              45  no change
JWH-073 (1-Butyl-3-(1-naphthoyl)indole)...................              45  no change
JWH-081 (1-Pentyl-3-[1-(4-methoxynaphthoyl)]indole).......              30  no change
JWH-122 (1-Pentyl-3-(4-methyl-1-naphthoyl)indole).........              30  no change
JWH-200 (1-[2-(4-Morpholinyl)ethyl]-3-(1-naphthoyl)indole)              35  no change
JWH-203 (1-Pentyl-3-(2-chlorophenylacetyl)indole).........              30  no change
JWH-250 (1-Pentyl-3-(2-methoxyphenylacetyl)indole)........              30  no change
JWH-398 (1-Pentyl-3-(4-chloro-1-naphthoyl)indole).........              30  no change
Ketobemidone..............................................              30  no change
Levomoramide..............................................              25  no change
Levophenacylmorphan.......................................              25  no change
Lysergic acid diethylamide (LSD)..........................              40  no change
MAB-CHMINACA; ADB-CHMINACA (N-(1-amino-3,3-dimethyl-1-                  30  no change
 oxobutan-2-yl)-1-(cyclohexylmethyl)-1H-indazole-3-
 carboxamide).
MDMB-CHMICA; MMB-CHMINACA(methyl 2-(1-(cyclohexylmethyl)-               30  no change
 1H-indole-3-carboxamido)-3,3-dimethylbutanoate).
MDMB-FUBINACA (methyl 2-(1-(4-fluorobenzyl)-1H-indazole-3-              30  no change
 carboxamido)-3,3-dimethylbutanoate).
MMB-CHMICA-(AMB-CHMICA); Methyl-2-(1-(cyclohexylmethyl)-1H-             25  no change
 indole-3-carboxamido)-3-methylbutanoate.
Marihuana.................................................       3,200,000  no change
Mecloqualone..............................................              30  no change
Mescaline.................................................              25  no change
Methaqualone..............................................              60  no change
Methcathinone.............................................              25  no change
Methyoxyacetyl fentanyl...................................              30  no change
Methyldesorphine..........................................               5  no change
Methyldihydromorphine.....................................              25  no change
Morpheridine..............................................              25  no change
Morphine methylbromide....................................               5  no change
Morphine methylsulfonate..................................               5  no change
Morphine-N-oxide..........................................             150  no change
MT-45.....................................................              30  no change
Myrophine.................................................              25  no change
NM2201; Naphthalen-1-yl 1-(5-fluoropentyl)-1H-indole-3-                 25  no change
 carboxylate.
N,N-Dimethylamphetamine...................................              25  no change
Naphyrone.................................................              25  no change
N-Ethyl-1-phenylcyclohexylamine...........................               5  25
N-Ethyl-3-piperidyl benzilate.............................              10  no change
N-Ethylamphetamine........................................              24  no change
N-Ethylhexedrone..........................................              25  no change
N-Ethylpentylone, ephylone................................              30  no change
N-Hydroxy-3,4-methylenedioxyamphetamine...................              24  no change
N-Methyl-3-Piperidyl Benzilate............................              30  no change
Nicocodeine...............................................              25  no change
Nicomorphine..............................................              25  no change
Noracymethadol............................................              25  no change
Norlevorphanol............................................              55  no change
Normethadone..............................................              25  no change
Normorphine...............................................              40  no change
Norpipanone...............................................              25  no change
Ocfentanil................................................              25  no change
Ortho-fluorofentanyl, 2-fluorofentanyl....................              30  no change
Para-chloroisobutyryl fentanyl............................              30  no change
Para-fluorofentanyl.......................................              25  no change
Para-fluorobutyryl fentanyl...............................              25  no change
Para-methoxybutyryl fentanyl..............................              30  no change
Parahexyl.................................................               5  no change
PB-22; QUPIC..............................................              20  no change
Pentedrone................................................              25  no change
Pentylone.................................................              25  no change
Phenadoxone...............................................              25  no change
Phenampromide.............................................              25  no change
Phenomorphan..............................................              25  no change
Phenoperidine.............................................              25  no change
Pholcodine................................................               5  no change
Piritramide...............................................              25  no change
Proheptazine..............................................              25  no change

[[Page 54420]]

 
Properidine...............................................              25  no change
Propiram..................................................              25  no change
Psilocybin................................................              30  no change
Psilocyn..................................................              50  no change
Racemoramide..............................................              25  no change
SR-18 and RCS-8 (1-Cyclohexylethyl-3-(2-                                45  no change
 methoxyphenylacetyl)indole).
SR-19 and RCS-4 (1-Pentyl-3-[(4-methoxy)-benzoyl]indole)..              30  no change
Tetrahydrocannabinols.....................................         384,460  no change
Tetrahydrofuranyl fentanyl................................              15  no change
Thebacon..................................................              25  no change
Thiafentanil..............................................              25  no change
Thiofentanyl..............................................              25  no change
THJ-2201 ([1-(5-fluoropentyl)-1H-indazol-3-yl](naphthalen-              30  no change
 1-yl)methanone).
Tilidine..................................................              25  no change
Trimeperidine.............................................              25  no change
UR-144 (1-pentyl-1H-indol-3-yl)(2,2,3,3-                                25  no change
 tetramethylcyclopropyl)methanone.
U-47700...................................................              30  no change
Valeryl fentanyl..........................................              25  no change
----------------------------------------------------------------------------------------------------------------
                                                   Schedule II
----------------------------------------------------------------------------------------------------------------
1-Phenylcyclohexylamine...................................              15  no change
1-Piperidinocyclohexanecarbonitrile.......................              25  no change
4-Anilino-N-phenethyl-4-piperidine (ANPP).................         934,956  no change
Alfentanil................................................           3,260  no change
Alphaprodine..............................................               2  25
Amobarbital...............................................          20,100  no change
Amphetamine (for conversion)..............................      14,137,578  no change
Amphetamine (for sale)....................................      47,000,000  42,400,000
Bezitramide...............................................              25  no change
Carfentanil...............................................              20  no change
Cocaine...................................................          82,127  73,090
Codeine (for conversion)..................................       3,225,000  no change
Codeine (for sale)........................................      35,341,292  no change
Dextropropoxyphene........................................              35  no change
Dihydrocodeine............................................         156,713  no change
Dihydroetorphine..........................................               2  25
Diphenoxylate (for conversion)............................          14,100  no change
Diphenoxylate (for sale)..................................         770,800  no change
Ecgonine..................................................          88,134  78,439
Ethylmorphine.............................................              30  no change
Etorphine hydrochloride...................................              32  no change
Fentanyl..................................................         934,956  no change
Glutethimide..............................................              25  no change
Hydrocodone (for conversion)..............................           1,250  no change
Hydrocodone (for sale)....................................      34,836,854  33,997,285
Hydromorphone.............................................       3,512,651  no change
Isomethadone..............................................              30  no change
Levo-alphacetylmethadol (LAAM)............................               5  25
Levomethorphan............................................              30  no change
Levorphanol...............................................          38,000  31,730
Lisdexamfetamine..........................................      21,000,000  no change
Meperidine................................................       1,463,873  1,119,862
Meperidine Intermediate-A.................................              30  no change
Meperidine Intermediate-B.................................              30  no change
Meperidine Intermediate-C.................................              30  no change
Metazocine................................................              15  no change
Methadone (for sale)......................................      25,619,700  no change
Methadone Intermediate....................................      27,673,600  no change
Methamphetamine...........................................       1,213,603  no change
----------------------------------------------------------------------------------------------------------------
 [678,878 grams of levo-desoxyephedrine for use in a non-controlled, non-prescription product; 505,231 grams for
   methamphetamine mostly for conversion to a schedule III product; and 29,494 grams for methamphetamine (for
                                                     sale)]
----------------------------------------------------------------------------------------------------------------
Methylphenidate...........................................      57,438,334  no change
Metopon...................................................              25  no change
Moramide-intermediate.....................................              25  no change
Morphine (for conversion).................................       4,089,000  3,376,696
Morphine (for sale).......................................      33,756,703  no change
Nabilone..................................................          62,000  no change
Noroxymorphone (for conversion)...........................      22,044,741  no change
Noroxymorphone (for sale).................................         376,000  no change

[[Page 54421]]

 
Opium (powder)............................................         250,000  no change
Opium (tincture)..........................................         530,837  no change
Oripavine.................................................      33,010,750  no change
Oxycodone (for conversion)................................         914,010  725,998
Oxycodone (for sale)......................................      67,593,983  65,667,554
Oxymorphone (for conversion)..............................      28,204,371  no change
Oxymorphone (for sale)....................................         829,051  658,515
Pentobarbital.............................................      25,850,000  no change
Phenazocine...............................................              25  no change
Phencyclidine.............................................              35  no change
Phenmetrazine.............................................              25  no change
Phenylacetone.............................................              40  no change
Piminodine................................................              25  no change
Racemethorphan............................................               5  no change
Racemorphan...............................................               5  no change
Remifentanil..............................................           3,000  no change
Secobarbital..............................................         172,100  no change
Sufentanil................................................           4,000  no change
Tapentadol................................................      13,447,541  no change
Thebaine..................................................      70,829,235  59,284,070
----------------------------------------------------------------------------------------------------------------
                                                List I Chemicals
----------------------------------------------------------------------------------------------------------------
Ephedrine (for conversion)................................              25  100
Ephedrine (for sale)......................................       4,756,000  no change
Phenylpropanolamine (for conversion)......................      14,100,000  no change
Phenylpropanolamine (for sale)............................       7,990,000  16,590,000
Pseudoephedrine (for conversion)..........................           1,000  no change
Pseudoephedrine (for sale)................................     200,382,900  no change
----------------------------------------------------------------------------------------------------------------

    The Acting Administrator further proposes that aggregate production 
quotas for all other schedule I and II controlled substances included 
in 21 CFR 1308.11 and 1308.12 remain at zero. In accordance with 21 CFR 
1303.13 and 21 CFR 1315.13, upon consideration of the relevant factors, 
the Acting Administrator may adjust the 2020 aggregate production 
quotas and assessment of annual needs as needed.

Conclusion

    After consideration of any comments or objections, or after a 
hearing, if one is held, the Acting Administrator will issue and 
publish in the Federal Register a final order establishing any 
adjustment of 2020 aggregate production quota for each basic class of 
controlled substances in schedules I and II and the assessment of 
annual needs for the list I chemicals ephedrine, pseudoephedrine, and 
phenylpropanolamine. 21 CFR 1303.13(c) and 1315.13(f).

Timothy J. Shea,
Acting Administrator.
[FR Doc. 2020-19308 Filed 8-31-20; 8:45 am]
BILLING CODE P