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 2021, 49346-49354 [2021-18935]

Agencies

• Drug Enforcement Administration
• Department of Justice

[Federal Register Volume 86, Number 168 (Thursday, September 2, 2021)]
[Notices]
[Pages 49346-49354]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2021-18935]


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DEPARTMENT OF JUSTICE

Drug Enforcement Administration

[Docket No. DEA-688A]


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 2021

AGENCY: Drug Enforcement Administration, Department of Justice.

ACTION: Notice with request for comments.

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

SUMMARY: The Drug Enforcement Administration proposes to adjust the 
2021 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 4, 2021. 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 her 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 2021 
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-688A'' 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 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) 776-2265.

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 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

[[Page 49347]]

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

Legal Authority and Background

    Section 306 of the Controlled Substances Act (CSA) (21 U.S.C. 826) 
requires the Attorney General to establish aggregate production quotas 
for each basic class of controlled substance listed in schedules I and 
II and for the list I chemicals ephedrine, pseudoephedrine, and 
phenylpropanolamine. The Attorney General has delegated this function 
to the Administrator of DEA pursuant to 28 CFR 0.100.
    DEA established the 2021 aggregate production quotas for substances 
in schedules I and II and the assessment of annual needs for the list I 
chemicals ephedrine, pseudoephedrine, and phenylpropanolamine on 
November 30, 2020 (85 FR 76604). 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.

Analysis for Proposed Adjusted 2021 Aggregate Production Quotas and 
Assessment of Annual Needs

    DEA proposes to adjust the established 2021 aggregate production 
quotas to be manufactured in the United States in 2021 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. However, DEA's analysis does not suggest the need for 
adjustment of the 2021 assessment of annual needs for the List I 
chemicals.

Factors for Determining the Proposed Adjustments

    In determining the proposed adjustments, the 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 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 2021 by 
considering the factors summarized below:

    (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, 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 Sec. 
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 Sec. 1303.24(b) and 1315.24(b) or 
abandoned pursuant to Sec. 1303.27 and 1315.27; and
    (5) other factors affecting medical, 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 Administrator finds relevant, including 
changes in the currently accepted medical use in treatment with the 
class 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).

    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). Pursuant to 
these factors, DEA has determined that any calculated changes from the 
previously determined initial calculations are slight and not 
statistically significant 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 2020 year-end 
inventories, 2020 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 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 evaluating whether there is a need for adjustment of the 2021 
assessment of annual needs for List I chemicals, 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). However, DEA's analysis does not 
suggest the need for adjustment of the 2021 assessment of annual needs.

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 
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

[[Page 49348]]

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.'' 21 U.S.C. 826(i)(1)(B).
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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).
---------------------------------------------------------------------------

    In February 2021, DEA sent letters to the Centers for Disease 
Control and Prevention (CDC), Centers for Medicare and Medicaid 
Services (CMS), and the states requesting overdose death and 
overprescribing data that could be considered for estimating diversion. 
DEA did not receive information from CMS. However, DEA did receive 
information from the CDC in June 2021 and has started to receive 
information from the states. DEA has begun to receive Prescription Drug 
Monitoring Program (PDMP) data from the states in a format that will 
allow the Agency to develop a more robust methodology to assist in the 
determination of the diversion estimate in the future. This information 
will be considered in determining the estimates of diversion for the 
five covered controlled substances in the 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 2022.
    To update the estimates of diversion, DEA used data from the Drug 
Theft and Loss Report, Statistical Management Analysis & Reporting 
Tools System (SMARTS), and System to Retrieve Information on Drug 
Evidence (STRIDE) 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 reports submitted 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 grams of the controlled substance being diverted. 
Below, DEA has updated the chart to include estimations of diversion 
for each of the covered controlled substances.

------------------------------------------------------------------------
 
------------------------------------------------------------------------
                    Diversion estimates for 2020 (g)
------------------------------------------------------------------------
Fentanyl.....................................................        184
Hydrocodone..................................................     20,759
Hydromorphone................................................        946
Oxycodone....................................................     47,316
Oxymorphone..................................................        534
------------------------------------------------------------------------

    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). Pursuant to 
these factors, DEA has determined that any calculated changes from the 
previously determined initial calculations are slight and not 
statistically significant from the quantities originally calculated for 
the extent of diversion that were applied to the initial aggregate 
production quota valuations.

Proposed Adjustments for the 2021 Aggregate Production Quotas and 
Assessment of Annual Needs

    DEA is proposing significant increases to the APQs of the schedule 
I substances psilocybin, psilocin, marihuana, and marihuana extract, 
which are directly related to increased interest by DEA registrants in 
the use of hallucinogenic controlled substances for research and 
clinical trial purposes. DEA firmly believes in supporting regulated 
research of schedule I controlled substances. Therefore, the APQ 
increases reflect the need to fulfill research and development 
requirements in the production of new drug products, and the study of 
marijuana effects in particular, as necessary steps toward potential 
Food and Drug Administration (FDA) approval of new drug products.
    The DEA established the 2021 aggregate production quotas for 
substances in schedules I and II on November 30, 2020 (85 FR 76604). 
Subsequent to that publication, DEA published in the Federal Register 
two final rules to permanently schedule 14 specific fentanyl-related 
substances under the CSA (86 FR 22113, April 27, 2021, and 86 FR 23602, 
May 4, 2021). The specific fentanyl-related substances are 2'-fluoro 2-
fluorofentanyl, 4'-Methyl acetyl fentanyl, beta-Methyl fentanyl, beta-
Phenyl fentanyl, Fentanyl carbamate, ortho-Fluoroacryl fentanyl, ortho-
Fluorobutyryl fentanyl, ortho-Fluoroisobutyryl fentanyl, ortho-Methyl 
acetylfentanyl, ortho-Methyl methoxyacetyl fentanyl, para-Fluoro 
furanyl fentanyl, para-Methylfentanyl, Phenyl fentanyl, and Thiofuranyl 
fentanyl. As a result, these substances will continue to be subject to 
the CSA schedule I controls and are now being assigned individual 
aggregate production quotas.
    On March 1, 2021, DEA published a temporary scheduling order 
placing Brorphine in schedule I of the CSA (86 FR 11862), making all 
regulatory controls pertaining to schedule I controlled substances 
applicable to the manufacture of these substances, including the 
requirement to establish an aggregate production quota pursuant to 21 
U.S.C. 826 and 21 CFR part 1303. This notice proposes to establish an 
aggregate production quota for this substance.
    On May 7, 2021, DEA published an interim final rule placing 
serdexmethylphenidate, a component in a combination drug product 
recently approved by FDA for the treatment of ADHD in patients six 
years of age and older, in schedule IV of the CSA (86 FR 24487). 
Serdexmethylphenidate is manufactured from methylphenidate, a schedule 
II controlled substance. In order to more accurately estimate and 
manage the quantity of methylphenidate necessary for direct formulation 
into schedule II drug products versus the

[[Page 49349]]

quantity of methylphenidate necessary for the manufacturing of 
serdexmethylphenidate or other substances, DEA has delineated 
methylphenidate into methylphenidate (for sale) and methylphenidate 
(for conversion). This notice proposes to establish an aggregate 
production quota for methylphenidate (for conversion).
    On June 20, 2021, DEA published the final rule to place 
oliceridine, a medication recently approved by FDA for medical use as 
an intravenous drug for the management of acute pain severe enough to 
require an intravenous opioid analgesic and for patients for whom 
alternative treatments are inadequate, in schedule II of the CSA 
effective July 12, 2021 (86 FR 30772). The placement of oliceridine in 
schedule II of the CSA, makes all regulatory controls pertaining to 
schedule II controlled substances applicable to the manufacture of this 
substance, including the requirement to establish an aggregate 
production quota pursuant to 21 U.S.C. 826 and 21 CFR part 1303.
    The Administrator, therefore, proposes to adjust the 2021 aggregate 
production quotas for certain schedule I and II controlled substances. 
The Administrator does not propose an adjustment to the assessments of 
annual needs for the list I chemicals ephedrine, pseudoephedrine, and 
phenylpropanolamine. The proposed adjusted APQs, as expressed in grams 
of anhydrous acid or base, are as follows:

------------------------------------------------------------------------
                                           Established  Proposed revised
                                           2021 quotas     2021 quotas
               Basic class                             -----------------
                                          -------------
                                               (g)             (g)
------------------------------------------------------------------------
                          Temporarily Scheduled
------------------------------------------------------------------------
Brorphine................................          N/A  30.
------------------------------------------------------------------------
                               Schedule I
------------------------------------------------------------------------
1-[1-(2-Thienyl)cyclohexyl]pyrrolidine...           20  no change.
1-(1-Phenylcyclohexyl)pyrrolidine........           15  30.
1-(2-Phenylethyl)-4-phenyl-4-                       10  no change.
 acetoxypiperidine.
1-(5-Fluoropentyl)-3-(1-naphthoyl)indole            30  no change.
 (AM2201).
1-(5-Fluoropentyl)-3-(2-                            30  no change.
 iodobenzoyl)indole (AM694).
1-Benzylpiperazine.......................           25  no change.
1-Methyl-4-phenyl-4-propionoxypiperidine.           10  no change.
1-[1-(2-Thienyl)cyclohexyl]piperidine....           15  no change.
2'-fluoro 2-fluorofentanyl...............          N/A  30.
2-(2,5-Dimethoxy-4-ethylphenyl)ethanamine           30  no change.
 (2C-E).
2-(2,5-Dimethoxy-4-                                 30  no change.
 methylphenyl)ethanamine (2C-D).
2-(2,5-Dimethoxy-4-nitro-                           30  no change.
 phenyl)ethanamine (2C-N).
2-(2,5-Dimethoxy-4-n-                               30  no change.
 propylphenyl)ethanamine (2C-P).
2-(2,5-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-                                    30  no change.
 dimethoxyphenyl)ethanamine (2C-C).
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            30  no change.
 (2C-I).
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-                                  25  no change.
 propylthiophenethylamine.
2,5-Dimethoxyamphetamine (DMA)...........           25  no change.
2-[4-(Ethylthio)-2,5-                               30  no change.
 dimethoxyphenyl]ethanamine (2C-T-2).
2-[4-(Isopropylthio)-2,5-                           30  no change.
 dimethoxyphenyl]ethanamine (2C-T-4).
3,4,5-Trimethoxyamphetamine..............           30  no change.
3,4-Methylenedioxyamphetamine (MDA)......           55  no change.
3,4-Methylenedioxymethamphetamine (MDMA).           50  no change.
3,4-Methylenedioxy-N-ethylamphetamine               40  no change.
 (MDEA).
3,4-Methylenedioxy-N-methylcathinone                40  no change.
 (methylone).
3,4-Methylenedioxypyrovalerone (MDPV)....           35  no change.
3-FMC; 3-Fluoro-N-methylcathinone........           25  no change.
3-Methylfentanyl.........................           30  no change.
3-Methylthiofentanyl.....................           30  no change.
4'-Methyl acetyl fentanyl................          N/A  30.
4-Bromo-2,5-dimethoxyamphetamine (DOB)...           30  no change.
4-Bromo-2,5-dimethoxyphenethylamine (2-             25  no change.
 CB).
4-Chloro-[alpha]-pyrrolidinovalerophenone           25  no change.
 (4-chloro-alpha-PVP).
4CN-Cumyl-Butanica, 1-(4-Cyanobutyl)-N-(2-          25  no change.
 phenylpropan-2-yl)-1H-indazole-3-
 carboximide.
4-Fluoroisobutyryl fentanyl..............           30  no change.
4-FMC; Flephedrone.......................           25  no change.
4-MEC; 4-Methyl-N-ethylcathinone.........           25  no change.
4-Methoxyamphetamine.....................          150  no change.
4-Methyl-2,5-dimethoxyamphetamine (DOM)..           25  no change.
4-Methylaminorex.........................           25  no change.
4-Methyl-N-methylcathinone (mephedrone)..           45  no change.
4-Methyl-[alpha]-ethylaminopentiophenone            25  no change.
 (4-MEAP).
4-Methyl-[alpha]-pyrrolidinohexiophenone            25  no change.
 (MPHP).
4-Methyl-[alpha]-pyrrolidinopropiophenone           25  no change.
 (4-MePPP).

[[Page 49350]]

 
5-(1,1-Dimethylheptyl)-2-[(1R,3S)-3-                50  no change.
 hydroxycyclohexyl]-phenol.
5-(1,1-Dimethyloctyl)-2-[(1R,3S)-3-                 40  no change.
 hydroxycyclohexyl]-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-                25  no change.
 oxobutan-2-yl)-1-(5-fluoropentyl)-1H-
 indazole-3-carboxamide.
5F-CUMYL-P7AICA; (1-(5-fluoropentyl)-N-(2-          25  no change.
 phenylpropan-2-yl)-1H-pyrrolo[2,3-
 b]pyridine-3-carboximide).
5F-ADB; 5F-MDMB-PINACA (methyl 2-(1-(5-             30  no change.
 fluoropentyl)-1H-indazole-3-carboxamido)-
 3,3-dimethylbutanoate).
5F-AMB (methyl 2-(1-(5-fluoropentyl)-1H-            30  no change.
 indazole-3-carboxamido)-3-
 methylbutanoate).
5F-APINACA; 5F-AKB48 (N-(adamantan-1-yl)-           30  no change.
 1-(5-fluoropentyl)-1H-indazole-3-
 carboxamide).
5-Fluoro-PB-22; 5F-PB-22.................           20  no change.
5-Fluoro-UR144, XLR11 ([1-(5-fluoro-                25  no change.
 pentyl)-1H-indol-3-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.........           35  no change.
AB-CHMINACA..............................           30  no change.
AB-FUBINACA..............................           50  no change.
AB-PINACA................................           30  no change.
ADB-FUBINACA (N-(1-amino-3,3-dimethyl-1-            30  no change.
 oxobutan-2-yl)-1-(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-              50  no change.
 oxobutan-2-yl)-1-pentyl-1H-indazole-3-
 carboxamide).
AH-7921..................................           30  no change.
All other tetrahydrocannabinol...........        1,000  no change.
Allylprodine.............................           25  no change.
Alphacetylmethadol.......................           25  no change.
alpha-Ethyltryptamine....................           25  no change.
Alphameprodine...........................           25  no change.
Alphamethadol............................           25  no change.
Alphaprodine.............................           25  no change.
alpha-Methylfentanyl.....................           30  no change.
alpha-Methylthiofentanyl.................           30  no change.
alpha-Methyltryptamine (AMT).............           25  no change.
alpha-Pyrrolidinobutiophenone ([alpha]-             25  no change.
 PBP).
alpha-Pyrrolidinoheptaphenone (PV8)......           25  no change.
alpha-Pyrrolidinohexanophenone ([alpha]-            25  no change.
 PHP).
alpha-Pyrrolidinopentiophenone ([alpha]-            25  no change.
 PVP).
Aminorex.................................           25  no change.
Anileridine..............................           20  no change.
APINCA, AKB48 (N-(1-adamantyl)-1-pentyl-            25  no change.
 1H-indazole-3-carboxamide).
Benzethidine.............................           25  no change.
Benzylmorphine...........................           30  no change.
Betacetylmethadol........................           25  no change.
beta-Hydroxy-3-methylfentanyl............           30  no change.
beta-Hydroxyfentanyl.....................           30  no change.
beta-Hydroxythiofentanyl.................           30  no change.
beta-Methyl fentanyl.....................          N/A  30.
beta-Phenyl fentanyl.....................          N/A  30.
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.
d-9-THC..................................      384,460  no change.
Desomorphine.............................           25  no change.
Dextromoramide...........................           25  no change.
Diapromide...............................           20  no change.
Diethylthiambutene.......................           20  no change.

[[Page 49351]]

 
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...............................           25  no change.
Drotebanol...............................           25  no change.
Ethylmethylthiambutene...................           25  no change.
Etorphine................................           30  no change.
Etoxeridine..............................           25  no change.
Fenethylline.............................           30  no change.
Fentanyl carbamate.......................          N/A  30.
Fentanyl related substances..............          600  no change.
FUB-144..................................           25  no change.
FUB-AKB48................................           25  no change.
FUB-AMB, MMB-Fubinaca, AMB-Fubinaca......           25  no change.
Furanyl fentanyl.........................           30  no change.
Furethidine..............................           25  no change.
gamma-Hydroxybutyric acid................   29,417,000  no change.
Heroin...................................           45  no change.
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-                   35  no change.
 naphthoyl)indole).
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-                          30  no change.
 methoxynaphthoyl)]indole).
JWH-122 (1-Pentyl-3-(4-methyl-1-                    30  no change.
 naphthoyl)indole).
JWH-200 (1-[2-(4-Morpholinyl)ethyl]-3-(1-           35  no change.
 naphthoyl)indole).
JWH-203 (1-Pentyl-3-(2-                             30  no change.
 chlorophenylacetyl)indole).
JWH-250 (1-Pentyl-3-(2-                             30  no change.
 methoxyphenylacetyl)indole).
JWH-398 (1-Pentyl-3-(4-chloro-1-                    30  no change.
 naphthoyl)indole).
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-             30  no change.
 3,3-dimethyl-1-oxobutan-2-yl)-1-
 (cyclohexylmethyl)-1H-indazole-3-
 carboxamide).
MDMB-CHMICA; MMB-CHMINACA(methyl 2-(1-              30  no change.
 (cyclohexylmethyl)-1H-indole-3-
 carboxamido)-3,3-dimethylbutanoate).
MDMB-FUBINACA (methyl 2-(1-(4-                      30  no change.
 fluorobenzyl)-1H-indazole-3-carboxamido)-
 3,3-dimethylbutanoate).
MMB-CHMICA-(AMB-CHMICA); Methyl-2-(1-               25  no change.
 (cyclohexylmethyl)-1H-indole-3-
 carboxamido)-3-methylbutanoate.
Marihuana................................    1,500,000  2,000,000.
Marihuana extract........................      200,000  500,000.
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-                       25  no change.
 fluoropentyl)-1H-indole-3-carboxylate.
N,N-Dimethylamphetamine..................           25  no change.
Naphyrone................................           25  no change.
N-Ethyl-1-phenylcyclohexylamine..........           25  no change.
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.

[[Page 49352]]

 
N-Methyl-3-Piperidyl Benzilate...........           30  no change.
Nicocodeine..............................           25  no change.
Nicomorphine.............................           25  no change.
Noracymethadol...........................           25  no change.
Norlevorphanol...........................        2,550  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.
ortho-Fluoroacryl fentanyl...............          N/A  30.
ortho-Fluorobutyryl fentanyl.............          N/A  30.
ortho-Fluoroisobutyryl fentanyl..........          N/A  30.
ortho-Methyl acetylfentanyl..............          N/A  30.
ortho-Methyl methoxyacetyl fentanyl......          N/A  30.
Para-chloroisobutyryl fentanyl...........           30  no change.
Para-fluorofentanyl......................           25  no change.
Para-fluorobutyryl fentanyl..............           25  no change.
para-Fluoro furanyl fentanyl.............          N/A  30.
para-Methylfentanyl......................          N/A  30.
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.
Phenyl fentanyl..........................          N/A  30.
Pholcodine...............................            5  no change.
Piritramide..............................           25  no change.
Proheptazine.............................           25  no change.
Properidine..............................           25  no change.
Propiram.................................           25  no change.
Psilocybin...............................           30  1,500.
Psilocyn.................................           50  1,000.
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)-           30  no change.
 benzoyl]indole).
Tetrahydrofuranyl fentanyl...............           15  no change.
Thebacon.................................           25  no change.
Thiafentanil.............................           25  no change.
Thiofentanyl.............................           25  no change.
Thiofuranyl fentanyl.....................          N/A  30.
THJ-2201 ([1-(5-fluoropentyl)-1H-indazol-           30  no change.
 3-yl](naphthalen-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)      937,758  no change.
Alfentanil...............................        3,260  no change.
Alphaprodine.............................           25  no change.
Amobarbital..............................       20,100  no change.
Bezitramide..............................           25  no change.
Carfentanil..............................           20  no change.
Cocaine..................................       68,576  no change.
Codeine (for conversion).................    1,612,500  no change.
Codeine (for sale).......................   27,616,684  no change.
D-amphetamine (for sale).................   21,200,000  no change.
D,l-amphetamine..........................   21,200,000  no change.
D-amphetamine (for conversion)...........   14,137,578  16,068,789.
Dextropropoxyphene.......................           35  no change.
Dihydrocodeine...........................      156,713  no change.

[[Page 49353]]

 
Dihydroetorphine.........................           25  no change.
Diphenoxylate (for conversion)...........       14,100  no change.
Diphenoxylate (for sale).................      770,800  no change.
Ecgonine.................................       68,576  no change.
Ethylmorphine............................           30  no change.
Etorphine hydrochloride..................           32  no change.
Fentanyl.................................      731,452  no change.
Glutethimide.............................           25  no change.
Hydrocodone (for conversion).............        1,250  no change.
Hydrocodone (for sale)...................   30,821,224  no change.
Hydromorphone............................    2,827,940  2,743,101.
Isomethadone.............................           30  no change.
L-amphetamine............................           30  no change.
Levo-alphacetylmethadol (LAAM)...........           25  no change.
Levomethorphan...........................           30  no change.
Levorphanol..............................       26,495  no change.
Lisdexamfetamine.........................   21,000,000  no change.
L-methamphetamine........................      587,229  no change.
Meperidine...............................      856,695  no change.
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..........................           50  no change.
D-methamphetamine (for conversion).......      485,020  no change.
D-methamphetamine (for sale).............       40,000  no change.
Methylphenidate (for conversion).........            0  15,300,000.
Methylphenidate (for sale)...............   57,438,334  no change.
Metopon..................................           25  no change.
Moramide-intermediate....................           25  no change.
Morphine (for conversion)................    3,376,696  no change.
Morphine (for sale)......................   27,784,062  26,505,995.
Nabilone.................................       62,000  no change.
Norfentanyl..............................           25  no change.
Noroxymorphone (for conversion)..........   22,044,741  no change.
Noroxymorphone (for sale)................      376,000  no change.
Oliceridine..............................          N/A  22,500.
Opium (powder)...........................      250,000  no change.
Opium (tincture).........................      530,837  no change.
Oripavine................................   33,010,750  no change.
Oxycodone (for conversion)...............      620,887  no change.
Oxycodone (for sale).....................   57,110,032  no change.
Oxymorphone (for conversion).............   28,204,371  no change.
Oxymorphone (for sale)...................      563,174  no change.
Pentobarbital............................   25,850,000  30,766,670.
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.................................   57,137,944  no change.
------------------------------------------------------------------------
                            List I Chemicals
------------------------------------------------------------------------
Ephedrine (for conversion)...............          100  no change.
Ephedrine (for sale).....................    4,136,000  no change.
Phenylpropanolamine (for conversion).....   14,878,320  no change.
Phenylpropanolamine (for sale)...........   16,690,000  no change.
Pseudoephedrine (for conversion).........        1,000  no change.
Pseudoephedrine (for sale)...............  174,246,000  no change.
------------------------------------------------------------------------


[[Page 49354]]

    The 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 Administrator may adjust the 2021 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 Administrator will issue and publish in 
the Federal Register a final order establishing any adjustment of 2021 
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).

Anne Milgram,
Administrator.
[FR Doc. 2021-18935 Filed 9-1-21; 8:45 am]
BILLING CODE 4410-09-P