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 2021, 54407-54414 [2020-19285]

Agencies

• Drug Enforcement Administration
• Department of Justice

[Federal Register Volume 85, Number 170 (Tuesday, September 1, 2020)]
[Notices]
[Pages 54407-54414]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2020-19285]


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DEPARTMENT OF JUSTICE

Drug Enforcement Administration

[Docket No. DEA-688P]


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 2021

AGENCY: Drug Enforcement Administration, Department of Justice.

ACTION: Notice with request for comments.

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SUMMARY: The Drug Enforcement Administration (DEA) proposes to 
establish the 2021 aggregate production quotas for controlled 
substances in schedules I and II of the Controlled Substances Act (CSA) 
and assessment of annual needs for the list I chemicals ephedrine, 
pseudoephedrine, and phenylpropanolamine.

DATES: Interested persons may file written comments on this notice in 
accordance with 21 CFR 1303.11(c) and 1315.11(d). Electronic comments 
must be submitted, and written comments must be postmarked, on or 
before 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 2021 
aggregate production quotas for schedule I and II controlled 
substances, and an assessment of annual needs for the list I chemicals 
ephedrine, pseudoephedrine, and phenylpropanolamine.

ADDRESSES: To ensure proper handling of comments, please reference 
``Docket No. DEA-688P'' 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/DPW, 
8701 Morrissette Drive, Springfield, Virginia 22152.

FOR FURTHER INFORMATION CONTACT: Scott A. Brinks, 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 (FOIA) applies to all comments 
received. If you want to submit personal identifying information (such 
as your name, address, etc.) as part of your comment, but do not want 
it to be made publicly available, you must include the phrase 
``PERSONAL IDENTIFYING INFORMATION'' in the first paragraph of your 
comment. You must also place all the personal identifying information 
you do not want made publicly available in the first paragraph of your 
comment and identify what information you want redacted.
    If you want to submit confidential business information as part of 
your comment, but do not want it to be made publicly available, you 
must include the phrase ``CONFIDENTIAL BUSINESS INFORMATION'' in the 
first paragraph of your comment. You must also prominently identify 
confidential

[[Page 54408]]

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

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

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

    The proposed 2021 aggregate production quotas and assessment of 
annual needs represent those quantities of schedule I and II controlled 
substances, and the list I chemicals ephedrine, pseudoephedrine, and 
phenylpropanolamine, to be manufactured in the United States (U.S.) in 
2021 to provide for the estimated medical, scientific, research, and 
industrial needs of the United States, lawful export requirements, and 
the establishment and maintenance of reserve stocks. These quotas 
include imports of ephedrine, pseudoephedrine, and phenylpropanolamine, 
but do not include imports of controlled substances for use in 
industrial processes.

Aggregate Production Quotas

    In determining the proposed 2021 aggregate production quotas, the 
Acting Administrator has taken into account the criteria of 21 U.S.C. 
826(a) and 21 CFR 1303.11.\1\ The DEA proposes the aggregate production 
quotas for 2021 by considering the following seven factors:
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    \1\ Two additional aggregate production quotas factors were 
added when DEA published the Final Rule ``Controlled Substances 
Quotas'' in the Federal Register, 83 FR 32784, on July 16, 2018.
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    (1) Total net disposal of the class by all manufacturers during the 
current and 2 preceding years;
    (2) Trends in the national rate of net disposal of the class;
    (3) Total actual (or estimated) inventories of the class and of all 
substances manufactured from the class, and trends in inventory 
accumulation;
    (4) Projected demand for such class as indicated by procurement 
quotas requested pursuant to Sec.  1303.12;
    (5) The extent of any diversion of the controlled substance in the 
class;
    (6) Relevant information obtained from the Department of Health and 
Human Services (HHS), including from the Food and Drug Administration 
(FDA), the Centers for Disease Control and Prevention (CDC), and the 
Centers for Medicare and Medicaid Services (CMS), and relevant 
information obtained from the states; and
    (7) Other factors affecting medical, scientific, research, and 
industrial needs in the United States and lawful export requirements, 
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.

Assessment of Annual Needs

    In similar fashion, in determining the proposed 2021 assessment of 
annual needs for the list I chemicals ephedrine, pseudoephedrine, and 
phenylpropanolamine, the Acting Administrator has taken into account 
the criteria of 21 U.S.C. 826(a) and 21 CFR 1315.11 and considered the 
five following factors:
    (1) Total net disposal of the chemical by all manufacturers and 
importers during the current and 2 preceding years;
    (2) Trends in the national rate of net disposal of each chemical;
    (3) Total actual (or estimated) inventories of the chemical and of 
all substances manufactured from the chemical, and trends in inventory 
accumulation;
    (4) Projected demand for each chemical as indicated by procurement 
and import quotas requested pursuant to Sec.  1315.32; and
    (5) Other factors affecting medical, scientific, research, and 
industrial needs in the United States, lawful export requirements, and 
the establishment and maintenance of reserve stocks, as the 
Administrator finds relevant, including changes in the currently 
accepted medical use in treatment with the chemicals or the substances 
which are manufactured from them, 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 1315.11(b).
    As may be noted, the five assessment of annual needs factors 
considered are similar, but not identical, to five of the seven factors 
considered in determining the aggregate production quotas. In 
determining the proposed 2021 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).

Information From the Food and Drug Administration

    In accordance with part 1303 of Title 21, of the CFR, 21 U.S.C. 
826, and 42 U.S.C. 242, HHS continues to provide DEA with estimates of 
the quantities of select schedule I and II controlled substances and 
three list I chemicals that will be required to meet the legitimate 
medical domestic needs of the United States for a given calendar year. 
The FDA is responsible for providing these estimates and predictions of 
legitimate medical needs to DEA. FDA provides DEA with its predicted 
estimates of medical usage for selected controlled substances based on 
information available to them at a specific point in time to meet 
statutory requirements. FDA's predicted levels of medical need for the 
United States was expected to decline on average 36.52 percent for 
calendar year 2021. These declines were expected to occur across a 
variety of schedule II opioids including fentanyl, hydrocodone, 
hydromorphone, codeine, and morphine. However, FDA's predicted level of 
medical need for the United States was calculated by FDA at the 
beginning of the Coronavirus Disease 2019 (COVID-19) pandemic and, 
therefore, did not take into account changes in usage that are 
necessary to treat patients who require schedule II controlled 
substances. DEA has considered both the potential for diversion as well 
as the anticipated increase in demand for opioids used to treat 
patients with COVID-19 in the

[[Page 54409]]

table of proposed 2021 aggregate production quotas listed below as is 
required pursuant to 21 CFR 1303.11(b)(7).
    With regard to certain schedule II stimulants (amphetamine, 
methylphenidate, and lisdexamfetamine) that are widely used to treat 
patients with attention deficit hyperactivity disorder (ADHD), FDA 
predicted a 0.5 percent decline in domestic medical use. DEA noted that 
although usage is not forecasted to have a significant increase in 
demand, FDA raised concerns over receiving a large volume of drug 
shortage notifications from patients for these medications as well as 
multiple recalls for out-of-specification lots of specific ADHD 
medications. DEA did consider FDA's concerns when calculating the 
aggregate production quota for these substances. While FDA's predicted 
estimate of usage remains stable, DEA has observed increases in the 
number of quota applications for product development efforts as well as 
exports for medical use for these controlled substances, and has 
proposed increases in these APQs to meet these demands. However, DEA is 
closely monitoring trends in licit stimulant use as DEA has grown 
increasingly concerned over the misuse of prescription stimulants among 
young adults and the demand for methamphetamine here in the U.S.
    For the factors listed in 21 CFR 1303.11(b)(3) and (4), DEA 
registered manufacturers of controlled substances in schedules I and II 
provided the information by submitting their individual data to several 
DEA database systems used for reporting inventory, distribution, 
manufacturing, and estimated quota requirements to meet sales forecasts 
for each class of controlled substance as required by regulations. See 
21 CFR 1303.12, 1303.22, and part 1304. Factor 1303.11(b)(5) requires 
DEA to consider the extent of diversion of controlled substances. The 
estimates of diversion as required by the SUPPORT Act are discussed 
later in the document. Diversion is defined as all distribution, 
dispensing, or other use of controlled substances for other than a 
legitimate medical purpose. In order to consider the extent of 
diversion, Federal, state, and local law enforcement seizures and 
registrant reports of diversion of controlled substances from 2019 were 
extracted from several DEA supported databases. The databases used 
include:
     Theft Loss Report database comprised of DEA registrant 
reported entries documenting diversion consisting of employee theft, 
break-ins, armed robberies, and material lost in transit;
     Statistical Management Analysis & Reporting Tools System 
(SMARTS) database comprised of laboratory drug submissions from seizure 
data and drug purchases made by DEA task force groups, tactical 
diversion squads, enforcement groups, and High Intensity Drug 
Trafficking Area (HIDTA) task force groups;
     System to Retrieve Information on Drug Evidence (STRIDE) 
database comprised of material seized by numerous law enforcement 
groups across the country including the Federal Bureau of Investigation 
(FBI) field offices; DEA field offices; U.S. Immigration and Customs 
Enforcement (ICE) offices; Bureau of Alcohol, Tobacco, Firearms and 
Explosives (ATF) offices; and metropolitan police departments.
    The data was categorized by basic drug class and the amount of 
active pharmaceutical ingredient (API) in the dosage form was 
delineated with an appropriate metric for use in proposing aggregate 
production quota values (i.e., weight). Because of the factor required 
by 21 CFR 1303.11(b)(6), DEA formally solicited HHS components CDC and 
CMS, in February 2020, requesting information including rates of 
overdose deaths and abuse and overall public health impact related to 
schedule II controlled substances, including the covered controlled 
substances. In April 2020, DEA formally solicited the states regarding 
information that would be helpful to DEA in estimating the amount of 
diversion, including PDMP data for the covered controlled substances. 
This information is considered pursuant to the SUPPORT Act discussed 
below. The Acting Administrator considered the effects of the COVID-19 
pandemic pursuant to 21 CFR 1303.11(b)(7) as discussed under 
Information from the FDA section.

Estimates of Diversion Pursuant to the Substance Use-Disorder 
Prevention That Promotes Opioid Recovery and Treatment for Patients and 
Communities Act

    The Substance Use-Disorder Prevention that Promotes Opioid Recovery 
and Treatment for Patients and Communities Act of 2018 (SUPPORT Act), 
Public Law 115-271, mandates that DEA, in consultation with HHS, 
determine reliable rates of overdose deaths, abuse, and overall public 
health impact as factors for the purpose of estimating diversion for 
each of the following five covered controlled substances: Fentanyl, 
hydrocodone, hydromorphone, oxycodone, and oxymorphone. The SUPPORT Act 
further mandates that DEA ``make appropriate quota reductions, as 
determined by the [Administrator], from the quota the [Administrator] 
would have otherwise established had such diversion not been 
considered.'' \2\ 21 U.S.C. 826(i)(1).
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    \2\ On October 23, 2019, DEA published a proposal to amend its 
quota regulations. 84 FR 56712. When finalized, the regulations will 
implement the amendments to the CSA made by the SUPPORT Act. 
However, 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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    In accordance with this mandate, DEA requested information from 
several reliable sources. In February 2020, DEA met with 
representatives from FDA, CDC, and CMS to discuss sharing relevant data 
that each agency maintains. For example, the CDC maintains information 
regarding unintentional overdose deaths and CMS maintains data 
regarding prescriptions for controlled substances filled under the 
Medicare Part D program. Following that meeting, DEA requested 
information on overdose deaths, overprescribing, and the public health 
impact of these categories from each of these federal partners.

Overdose Death Data Provided by the Centers for Disease Control and 
Prevention

    In May 2020, the CDC provided DEA with data from their National 
Vital Statistics System Mortality files for 2015 through 2017, which 
provided numerical, crude, and age-adjusted rates of drug overdose 
deaths involving the covered controlled substances aggregated by public 
health regions of the United States. The CDC noted that if the death 
involved more than one controlled substance, the death was counted in 
all involved substances. Further, CDC informed DEA that calendar year 
2018 data would not be available until the fall of 2020. The number of 
overdose deaths in which the covered controlled substance was 
identified, as provided by the CDC, is provided in Table 1 below. With 
respect to fentanyl, the data includes the covered controlled substance 
fentanyl and all known fentanyl analogues, which are not covered 
controlled substances under the SUPPORT Act.

[[Page 54410]]



                      Table 1: Overdose Deaths of Covered Controlled Substances, 2015-2017
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                                                                                                  Trend (percent
                                           2015                 2016                 2017           change from
                                                                                                   2015 to 2017)
----------------------------------------------------------------------------------------------------------------
Fentanyl and its Analogues.......  8,251..............  18,335.............  27,299.............             231
Hydrocodone......................  3,051..............  3,199..............  3,072..............               1
Hydromorphone....................  793................  743................  786................              -1
Oxycodone........................  5,792..............  6,199..............  6,053..............               5
Oxymorphone......................  1,006..............  1,077..............  900................             -11
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    Fentanyl and its analogues are the substances that continue to be 
the opioids involved in the vast majority of overdose deaths in the 
United States, increasing by 231 percent from 2015 through 2017.\3\ 
However, based on the data presented to DEA by the CDC, which did not 
differentiate between licit fentanyl and illicit fentanyl and its 
analogues, as well as analyzed seizure data from law enforcement 
activities, DEA believes that the vast majority of deaths involving 
fentanyl were not from products that were lawfully manufactured and 
distributed pursuant to the CSA but were from unlawfully manufactured 
and distributed fentanyl and fentanyl related substances. The 
information from the CDC also demonstrates a relatively stable number 
of overdose deaths involving oxycodone, hydrocodone, and hydromorphone. 
Overdose deaths involving oxymorphone show an 11 percent decline during 
this period. Whereas DEA is required to consider rates in overdose 
deaths pursuant to changes made by the SUPPORT Act, DEA has concluded 
that this data on overdose deaths for 2015 through 2017 cannot be 
reliably utilized to estimate the amount of diversion for the five 
covered controlled substances for the quota setting year (2021). 
However, this information continues to serve as an important reminder 
of the persistent role that controlled prescription opioids play in our 
Nation's opioid epidemic.
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    \3\ According to the CDC, there were an estimated 47,506 
unintentional overdose deaths involving a natural, semi-synthetic or 
synthetic opioid in 2017. More than half (57 percent) involved 
fentanyl and substances chemically similar to fentanyl. At the time 
of this publication, the CDC has released unintentional overdose 
statistics for 2018 and provisional estimates for 2019; however, 
deaths involving each of the five covered substances are not 
available for those years. Information about CDC's current mortality 
data may be found at: https://www.cdc.gov/drugoverdose/data/.
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Data From the Centers for Medicare and Medicaid Services

    In further consultation with HHS, DEA was advised that the Centers 
for Medicare and Medicaid Services (CMS) may have information related 
to diversion, such as reliable rates of overprescribing (doctor 
shopping and being prescribed significantly more medicine than is 
medically necessary). 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. While CMS was unable to generate 
a report, DEA will attempt to solicit the raw data from CMS to 
determine overprescribing rates based on CDC prescription guidance for 
schedule II substances and DEA's own parameters for doctor shopping.

Information From States' Attorneys General

    DEA also obtains information from the states to be considered in 
setting the aggregate production quotas. As such, DEA sent a letter to 
each state attorney general soliciting information that would be 
helpful in estimating the amount of diversion for the five covered 
controlled substances identified in the SUPPORT Act. In that letter, 
DEA indicated that it was specifically interested in obtaining 
information from each state's Prescription Drug Monitoring Program 
(PDMP) or any analysis of prescription data that would assist DEA in 
estimating diversion of covered controlled substances and setting 
appropriate quotas in compliance with the SUPPORT Act. DEA requested 
the data be provided to the agency by June 1, 2020, in order to provide 
the agency with adequate time to analyze the data and determine a 
methodology for inclusion in diversion estimates to be considered in 
proposing APQ values for the 2021 calendar year. Twenty states and U.S. 
territories acknowledged receipt of DEA's correspondence and nine of 
those states provided DEA with de-identified aggregated PDMP data. The 
list of states and territories responding to DEA's request for data is 
listed in Table 2.

    Table 2--States/Territories that Responded to DEA's Data Request
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                                     Acknowledged       Submitted PDMP
         State/territory                letter               data
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1. Connecticut..................  X.................  ..................
2. Delaware.....................  X.................  ..................
3. District of Columbia.........  X.................  ..................
4. Florida......................  X.................  X
5. Guam.........................  X.................  X
6. Illinois.....................  X.................  ..................
7. Louisiana....................  X.................  X
8. Maine........................  X.................  ..................
9. Massachusetts................  X.................  ..................
10. Michigan....................  X.................  ..................
11. Missouri....................  X.................  ..................
12. Montana.....................  X.................  ..................
13. New Hampshire...............  X.................  ..................
14. Ohio........................  X.................  X

[[Page 54411]]

 
15. Oklahoma....................  X.................  X
16. Oregon......................  X.................  ..................
17. South Dakota................  X.................  X
18. Texas.......................  X.................  X
19. West Virginia...............  X.................  X
20. Wyoming.....................  X.................  X
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    The data that DEA received varied in its form and content and was 
ultimately determined to be inapplicable at the national level.
    Data from PDMPs can be evaluated to identify common diversion 
schemes such as ``doctor shopping,'' a scheme in which a patient 
obtains controlled substances from multiple treatment providers without 
the providers knowing of the other prescriptions. In addition, 
information from PDMPs can assist in identifying ``red flags'' that 
could be evidence of diversion and misuse of covered controlled 
substances, such as: Over-prescribing; patients traveling long 
distances or across state lines to have prescriptions filled; early 
refills; and dangerous drug combinations such as the ``holy trinity,'' 
a cocktail of drugs consisting of an opioid, a benzodiazepine, and a 
commonly prescribed muscle relaxant such as carisoprodol, which when 
misused in combination, can be lethal. DEA has determined that analysis 
of raw data from state PDMPs on these five covered substances is 
essential for DEA to effectively estimate diversion of the covered 
controlled substances pursuant to the SUPPORT Act. DEA is currently 
exploring additional means to obtain PDMP data so that it may fulfill 
this statutory obligation while protecting the privacy of patients who 
obtain such prescriptions.

DEA Law Enforcement Data

    DEA extracted data from its Drug Theft and Loss, Statistical 
Management Analysis & Reporting Tools System (SMARTS) and System to 
Retrieve Information on Drug Evidence (STRIDE) databases, and 
aggregated the quantity of active pharmaceutical ingredient (API) of 
each covered controlled substance by metric weight where the data was 
available. From the databases, DEA gathered data involving employee 
theft, break-ins, armed robberies, and material lost in transit. DEA 
also used seizure data by law enforcement 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. DEA calculated the 
estimated 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. The estimate of diversion for each of the 
covered controlled substances is reported below:

    Table 3--Estimate of Diversion for Covered Controlled Substances.
------------------------------------------------------------------------
 
------------------------------------------------------------------------
                    Diversion Estimates for 2019 (kg)
------------------------------------------------------------------------
Fentanyl................................................           0.090
Hydrocodone.............................................          30.294
Hydromorphone...........................................           1.424
Oxycodone...............................................          60.959
Oxymorphone.............................................           1.311
------------------------------------------------------------------------

    In accordance with the SUPPORT Act, after estimating the amount of 
diversion for the foregoing five controlled substances, DEA made 
adjustments to the individual aggregate production quotas for each 
covered controlled substance by the corresponding quantities listed in 
the table.
    In determining the proposed 2021 assessment of annual needs, the 
DEA used the calculation methodology previously described in the 2010 
and 2011 assessment of annual needs (74 FR 60294, Nov. 20, 2009, and 75 
FR 79407, Dec. 20, 2010, respectively).
    The Acting Administrator, therefore, proposes to establish the 2021 
aggregate production quotas for certain schedule I and II controlled 
substances and assessment of annual needs for the list I chemicals 
ephedrine, pseudoephedrine, and phenylpropanolamine, expressed in grams 
of anhydrous acid or base, as follows:

------------------------------------------------------------------------
                                                               Proposed
                        Basic class                          2021 quotas
                                                                 (g)
------------------------------------------------------------------------
                               Schedule I
------------------------------------------------------------------------
1-[1-(2-Thienyl)cyclohexyl]pyrrolidine.....................           20
1-(1-Phenylcyclohexyl)pyrrolidine..........................           15
1-(2-Phenylethyl)-4-phenyl-4-acetoxypiperidine.............           10
1-(5-Fluoropentyl)-3-(1-naphthoyl)indole (AM2201)..........           30
1-(5-Fluoropentyl)-3-(2-iodobenzoyl)indole (AM694).........           30
1-Benzylpiperazine.........................................           25
1-Methyl-4-phenyl-4-propionoxypiperidine...................           10
1-[1-(2-Thienyl)cyclohexyl]piperidine......................           15
2-(2,5-Dimethoxy-4-ethylphenyl)ethanamine (2C-E)...........           30
2-(2,5-Dimethoxy-4-methylphenyl)ethanamine (2C-D)..........           30
2-(2,5-Dimethoxy-4-nitro-phenyl)ethanamine (2C-N)..........           30
2-(2,5-Dimethoxy-4-(n)-propylphenyl)ethanamine (2C-P)......           30
2-(2,5-Dimethoxyphenyl)ethanamine (2C-H)...................          100
2-(4-Bromo-2,5-dimethoxyphenyl)-N-(2-                                 30
 methoxybenzyl)ethanamine (25B-NBOMe; 2C-B-NBOMe; 25B;
 Cimbi-36).................................................
2-(4-Chloro-2,5-dimethoxyphenyl)ethanamine (2C-C)..........           30
2-(4-Chloro-2,5-dimethoxyphenyl)-N-(2-                                25
 methoxybenzyl)ethanamine (25C-NBOMe; 2C-C-NBOMe; 25C;
 Cimbi-82).................................................
2-(4-Iodo-2,5-dimethoxyphenyl)ethanamine (2C-I)............           30
2-(4-Iodo-2,5-dimethoxyphenyl)-N-(2-                                  30
 methoxybenzyl)ethanamine (25I-NBOMe; 2C-I-NBOMe; 25I;
 Cimbi-5)..................................................
2,5-Dimethoxy-4-ethylamphetamine (DOET)....................           25
2,5-Dimethoxy-4-(n)-propylthiophenethylamine...............           25
2,5-Dimethoxyamphetamine (DMA).............................           25
2-(4-Ethylthio-2,5-dimethoxyphenyl)ethanamine (2C-T-2).....           30

[[Page 54412]]

 
2-(4-(Isopropylthio)-2,5-dimethoxyphenyl)ethanamine (2C-T-            30
 4)........................................................
3,4,5-Trimethoxyamphetamine................................           30
3,4-Methylenedioxyamphetamine (MDA)........................           55
3,4-Methylenedioxymethamphetamine (MDMA)...................           50
3,4-Methylenedioxy-N-ethylamphetamine (MDEA)...............           40
3,4-Methylenedioxy-N-methylcathinone (methylone)...........           40
3,4-Methylenedioxypyrovalerone (MDPV)......................           35
3-Fluoro-N-methylcathinone (3-FMC).........................           25
3-Methylfentanyl...........................................           30
3-Methylthiofentanyl.......................................           30
4-Bromo-2,5-dimethoxyamphetamine (DOB).....................           30
4-Bromo-2,5-dimethoxyphenethylamine (2-CB).................           25
4-Chloro-alpha-pyrrolidinovalerophenone (4-chloro-alpha-              25
 PVP)......................................................
1-(4-Cyanobutyl)-N-(2-phenylpropan-2-yl)-1 H-indazole-3-              25
 carboximide (4CN-Cumyl-Butinaca)..........................
4-Fluoroisobutyryl fentanyl................................           30
4-Fluoro-N-methylcathinone (4-FMC; Flephedrone)............           25
4-Methyl-N-ethylcathinone (4-MEC)..........................           25
4-Methoxyamphetamine.......................................          150
4-Methyl-2,5-dimethoxyamphetamine (DOM)....................           25
4-Methylaminorex...........................................           25
4-Methyl-N-methylcathinone (mephedrone)....................           45
4-Methyl-alpha-ethylaminopentiophenone (4-MEAP)............           25
4-Methyl-alpha-pyrrolidinohexiophenone (MPHP)..............           25
4-Methyl-alpha-pyrrolidinopropiophenone (4-MePPP)..........           25
5-(1,1-Dimethylheptyl)-2-[(1R,3S)-3-hydroxycyclohexyl-                50
 phenol....................................................
5-(1,1-Dimethyloctyl)-2-[(1R,3S)3-hydroxycyclohexyl-phenol            40
 (cannabicyclohexanol or CP-47,497 C8-homolog).............
5F-CUMYL-PINACA............................................           25
5F-EDMB-PINACA.............................................           25
5F-MDMB-PICA...............................................           25
5F-AB-PINACA; N-(1-amino-3-methyl-1-oxobutan-2-yl)-1-(5-              25
 fluoropentyl)-1H-indazole-3-carboxamide...................
5F-CUMYL-P7AICA; (1-(5-fluoropentyl)-N-(2-phenylpropan-2-             25
 yl)-1H-pyrrolo[2,3-b]pyridine-3-carboximide)..............
5F-ADB; 5F-MDMB-PINACA (methyl 2-(1-(5-fluoropentyl)-1H-              30
 indazole-3-carboxamido)-3,3-dimethylbutanoate)............
5F-AMB (methyl 2-(1-(5-fluoropentyl)-1H-indazole-3-                   30
 carboxamido)-3-methylbutanoate)...........................
5F-APINACA; 5F-AKB48 (N-(adamantan-1-yl)-1-(5-fluoropentyl)-          30
 1H-indazole-3-carboxamide)................................
5-Fluoro-PB-22; 5F-PB-22...................................           20
5-Fluoro-UR144, XLR11 ([1-(5-fluoro-pentyl)-1H-indol-3-               25
 yl](2,2,3,3-tetramethylcyclopropyl)methanone..............
5-Methoxy-3,4-methylenedioxyamphetamine....................           25
5-Methoxy-N,N-diisopropyltryptamine........................           25
5-Methoxy-N,N-dimethyltryptamine...........................           25
AB-CHMINACA................................................           30
AB-FUBINACA................................................           50
AB-PINACA..................................................           30
ADB-FUBINACA (N-(1-amino-3,3-dimethyl-1-oxobutan-2-yl)-1-(4-          30
 fluorobenzyl)-1H-indazole-3-carboxamide)..................
Acetorphine................................................           25
Acetyl Fentanyl............................................          100
Acetyl-alpha-methylfentanyl................................           30
Acetyldihydrocodeine.......................................           30
Acetylmethadol.............................................           25
Acryl Fentanyl.............................................           25
ADB-PINACA (N-(1-amino-3,3-dimethyl-1-oxobutan-2-yl)-1-               50
 pentyl-1H-indazole-3-carboxamide).........................
AH-7921....................................................           30
All other tetrahydrocannabinol.............................        1,000
Allylprodine...............................................           25
Alphacetylmethadol.........................................           25
Alpha-Ethyltryptamine......................................           25
Alphameprodine.............................................           25
Alphamethadol..............................................           25
Alphaprodine...............................................           25
Alpha-Methylfentanyl.......................................           30
Alpha-Methylthiofentanyl...................................           30
Alpha-Methyltryptamine (AMT)...............................           25
Alpha-Pyrrolidinobutiophenone ([alpha]-PBP)................           25
Alpha-Pyrrolidinoheptaphenone (PV8)........................           25
Alpha-Pyrrolidinohexanophenone ([alpha]-PHP)...............           25
Alpha-Pyrrolidinopentiophenone ([alpha]-PVP)...............           25
Aminorex...................................................           25
Anileridine................................................           20
APINACA, AKB48 (N-(1-adamantyl)-1-pentyl-1H-indazole-3-               25
 carboxamide)..............................................
Benzethidine...............................................           25
Benzylmorphine.............................................           30
Betacetylmethadol..........................................           25
Beta-Hydroxy-3-methylfentanyl..............................           30
Beta-Hydroxyfentanyl.......................................           30
Beta-Hydroxythiofentanyl...................................           30
Betameprodine..............................................           25
Betamethadol...............................................            4
Betaprodine................................................           25
Bufotenine.................................................           15
Butylone...................................................           25
Butyryl fentanyl...........................................           30
Cathinone..................................................           40
Clonitazene................................................           25
Codeine methylbromide......................................           30
Codeine-N-oxide............................................          192
Cyclopentyl Fentanyl.......................................           30
Cyclopropyl Fentanyl.......................................           20
Cyprenorphine..............................................           25
Delta 9-THC................................................      384,460
Desomorphine...............................................           25
Dextromoramide.............................................           25
Diampromide................................................           20
Diethylthiambutene.........................................           20
Diethyltryptamine..........................................           25
Difenoxin..................................................        9,200
Dihydromorphine............................................      753,500
Dimenoxadol................................................           25
Dimepheptanol..............................................           25
Dimethylthiambutene........................................           20
Dimethyltryptamine.........................................           50
Dioxaphetyl butyrate.......................................           25
Dipipanone.................................................           25
Drotebanol.................................................           25
Ethylmethylthiambutene.....................................           25
Etorphine..................................................           30
Etoxeridine................................................           25
Fenethylline...............................................           30
Fentanyl related substances................................          600
FUB-144....................................................           25
FUB-AKB48..................................................           25
FUB-AMB, MMB-Fubinaca, AMB-Fubinaca........................           25
Furanyl fentanyl...........................................           30
Furethidine................................................           25
Gamma Hydroxybutyric Acid..................................   25,417,000
Heroin.....................................................           45
Hydromorphinol.............................................           40
Hydroxypethidine...........................................           25
Ibogaine...................................................           30
Isobutyryl Fentanyl........................................           25
JWH-018 and AM678 (1-Pentyl-3-(1-naphthoyl)indole).........           35
JWH-019 (1-Hexyl-3-(1-naphthoyl)indole)....................           45
JWH-073 (1-Butyl-3-(1-naphthoyl)indole)....................           45
JWH-081 (1-Pentyl-3-(1-(4-methoxynaphthoyl)indole).........           30
JWH-122 (1-Pentyl-3-(4-methyl-1-naphthoyl)indole)..........           30
JWH-200 (1-[2-(4-Morpholinyl)ethyl]-3-(1-naphthoyl)indole).           35
JWH-203 (1-Pentyl-3-(2-chlorophenylacetyl)indole)..........           30
JWH-250 (1-Pentyl-3-(2-methoxyphenylacetyl)indole).........           30
JWH-398 (1-Pentyl-3-(4-chloro-1-naphthoyl)indole)..........           30
Ketobemidone...............................................           30

[[Page 54413]]

 
Levomoramide...............................................           25
Levophenacylmorphan........................................           25
Lysergic acid diethylamide (LSD)...........................           40
MAB-CHMINACA; ADB-CHMINACA (N-(1-amino-3,3-dimethyl-1-                30
 oxobutan-2-yl)-1-(cyclohexylmethyl)-1H-indazole-3-
 carboxamide)..............................................
MDMB-CHMICA; MMB-CHMINACA(methyl 2-(1-(cyclohexylmethyl)-1H-          30
 indole-3-carboxamido)-3,3-dimethylbutanoate)..............
MDMB-FUBINACA (methyl 2-(1-(4-fluorobenzyl)-1H-indazole-3-            30
 carboxamido)-3,3-dimethylbutanoate).......................
MMB-CHMICA (AMB-CHMICA); Methyl-2-(1-(cyclohexylmethyl)-1H-           25
 indole-3-carboxamido)-3-methylbutanoate...................
Marihuana..................................................    1,500,000
Marihuana extract..........................................      200,000
Mecloqualone...............................................           30
Mescaline..................................................           25
Methaqualone...............................................           60
Methcathinone..............................................           25
Methoxyacetyl fentanyl.....................................           30
Methyldesorphine...........................................            5
Methyldihydromorphine......................................           25
Morpheridine...............................................           25
Morphine methylbromide.....................................            5
Morphine methylsulfonate...................................            5
Morphine-N-oxide...........................................          150
MT-45......................................................           30
Myrophine..................................................           25
NM2201; Naphthalen-1-yl 1-(5-fluoropentyl)-1H-indole-3-               25
 carboxylate...............................................
N,N-Dimethylamphetamine....................................           25
Naphyrone..................................................           25
N-Ethyl-1-phenylcyclohexylamine............................           25
N-Ethyl-3-piperidyl benzilate..............................           10
N-Ethylamphetamine.........................................           24
N-Ethylhexedrone...........................................           25
N-Ethylpentylone, ephylone.................................           30
N-Hydroxy-3,4-methylenedioxyamphetamine....................           24
N-Methyl-3-Piperidyl Benzilate.............................           30
Nicocodeine................................................           25
Nicomorphine...............................................           25
Noracymethadol.............................................           25
Norlevorphanol.............................................           55
Normethadone...............................................           25
Normorphine................................................           40
Norpipanone................................................           25
Ocfentanil.................................................           25
Ortho-fluorofentanyl, 2-fluorofentanyl.....................           30
Para-chloroisobutyryl fentanyl.............................           30
Para-fluorofentanyl........................................           25
Para-fluorobutyryl fentanyl................................           25
Para-methoxybutyryl fentanyl...............................           30
Parahexyl..................................................            5
PB-22; QUPIC...............................................           20
Pentedrone.................................................           25
Pentylone..................................................           25
Phenadoxone................................................           25
Phenampromide..............................................           25
Phenomorphan...............................................           25
Phenoperidine..............................................           25
Pholcodine.................................................            5
Piritramide................................................           25
Proheptazine...............................................           25
Properidine................................................           25
Propiram...................................................           25
Psilocybin.................................................           30
Psilocyn...................................................           50
Racemoramide...............................................           25
SR-18 and RCS-8 (1-Cyclohexylethyl-3-(2-                              45
 methoxyphenylacetyl)indole)...............................
SR-19 and RCS-4 (1-Pentyl-3-[(4-methoxy)-benzoyl]indole)...           30
Tetrahydrofuranyl fentanyl.................................           15
Thebacon...................................................           25
Thiafentanil...............................................           25
Thiofentanyl...............................................           25
THJ-2201 ( [1-(5-fluoropentyl)-1H-indazol-3-yl](naphthalen-           30
 1-yl)methanone)...........................................
Tilidine...................................................           25
Trimeperidine..............................................           25
UR-144 (1-pentyl-1H-indol-3-yl)(2,2,3,3-                              25
 tetramethylcyclopropyl)methanone..........................
U-47700....................................................           30
Valeryl fentanyl...........................................           25
------------------------------------------------------------------------
                               Schedule II
------------------------------------------------------------------------
1-Phenylcyclohexylamine....................................           15
1-Piperidinocyclohexanecarbonitrile........................           25
4-Anilino-N-phenethyl-4-piperidine (ANPP)..................      666,249
Alfentanil.................................................        3,260
Alphaprodine...............................................           25
Amobarbital................................................       20,100
Bezitramide................................................           25
Carfentanil................................................           20
Cocaine....................................................       68,576
Codeine (for conversion)...................................    1,612,500
Codeine (for sale).........................................   27,616,684
D-amphetamine (for sale)...................................   21,200,000
D-amphetamine (for conversion).............................   14,137,578
D-methamphetamine (for conversion).........................       485,02
D-methamphetamine (for sale)...............................       25,491
D,L-amphetamine............................................   21,200,000
D,L-methamphetamine........................................           50
Dextropropoxyphene.........................................           35
Dihydrocodeine.............................................      156,713
Dihydroetorphine...........................................           25
Diphenoxylate (for conversion).............................       14,100
Diphenoxylate (for sale)...................................      770,800
Ecgonine...................................................       68,576
Ethylmorphine..............................................           30
Etorphine hydrochloride....................................           32
Fentanyl...................................................      666,249
Glutethimide...............................................           25
Hydrocodone (for conversion)...............................        1,250
Hydrocodone (for sale).....................................   30,821,224
Hydromorphone..............................................    2,827,940
Isomethadone...............................................           30
L-amphetamine..............................................           30
L-methamphetamine..........................................      587,229
Levo-alphacetylmethadol (LAAM).............................           25
Levomethorphan.............................................           30
Levorphanol................................................       26,495
Lisdexamfetamine...........................................   21,000,000
Meperidine.................................................      856,695
Meperidine Intermediate-A..................................           30
Meperidine Intermediate-B..................................           30
Meperidine Intermediate-C..................................           30
Metazocine.................................................           15
Methadone (for sale).......................................   25,619,700
Methadone Intermediate.....................................   27,673,600
Methylphenidate............................................   57,438,334
Metopon....................................................           25
Moramide-intermediate......................................           25
Morphine (for conversion)..................................    3,376,696
Morphine (for sale)........................................   27,784,062
Nabilone...................................................       62,000
Norfentanyl................................................           25
Noroxymorphone (for conversion)............................   22,044,741
Noroxymorphone (for sale)..................................      376,000
Opium (powder).............................................      250,000
Opium (tincture)...........................................      530,837
Oripavine..................................................   33,010,750
Oxycodone (for conversion).................................      620,887
Oxycodone (for sale).......................................   57,110,032
Oxymorphone (for conversion)...............................   28,204,371
Oxymorphone (for sale).....................................      563,174
Pentobarbital..............................................   25,850,000
Phenazocine................................................           25
Phencyclidine..............................................           35
Phenmetrazine..............................................           25
Phenylacetone..............................................           40
Piminodine.................................................           25
Racemethorphan.............................................            5
Racemorphan................................................            5
Remifentanil...............................................        3,000
Secobarbital...............................................      172,100
Sufentanil.................................................        4,000
Tapentadol.................................................   13,447,541
Thebaine...................................................   57,137,944
------------------------------------------------------------------------
                            List I Chemicals
------------------------------------------------------------------------
Ephedrine (for conversion).................................          100
Ephedrine (for sale).......................................    4,136,000
Phenylpropanolamine (for conversion).......................   14,878,320
Phenylpropanolamine (for sale).............................   16,690,000
Pseudoephedrine (for conversion)...........................        1,000
Pseudoephedrine (for sale).................................  174,246,000
------------------------------------------------------------------------

    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.

Adjustments to the Aggregate Production Quotas During the COVID-19 
Public Health Emergency

    The establishment (and adjustment) of the aggregate production 
quotas for schedule I and II substances is a critical component of 
DEA's response to the threat posed by the ongoing COVID-19

[[Page 54414]]

public health emergency declared by the Secretary of Health and Human 
Services (HHS) on January 31, 2020, effective January 27, 2020, and as 
has been renewed in accordance with section 319(a)(2) of the Public 
Health Service Act (PHS Act) (42 U.S.C. 247d(a)(2)). On April 10, 2020, 
DEA increased the 2020 aggregate production quotas for certain schedule 
II controlled substances and list I chemicals after concluding that 
this action was necessary to ensure that there would be no supply 
disruptions for these substances for ventilated patients with this 
infectious disease.\4\ Despite this public health emergency, DEA 
remains focused on the challenges presented by opioid addiction and its 
effect on the health and wellbeing of the millions of Americans and 
their families who have become dependent upon or addicted to them. The 
potential for addiction and misuse exists in every community and 
remains a pressing health issue with significant social and economic 
implications.
---------------------------------------------------------------------------

    \4\ 85 FR 20302 (April 10, 2020).
---------------------------------------------------------------------------

    These proposed 2021 quotas reflect the quantity that DEA believes 
is necessary to meet the estimated medical, scientific, research, and 
industrial needs of the United States, to include any increase in 
demand for certain controlled substances used to treat patients with 
COVID-19. DEA remains committed to conducting continuous surveillance 
on the supply of schedule II controlled substances and list I chemicals 
necessary to treat patients with COVID-19, and, pursuant to his 
authority, the Acting Administrator will move swiftly and decisively to 
increase any 2021 aggregate production quota that he determines is 
necessary to address an unforeseen increase in demand, should that 
occur.
    In accordance with 21 CFR 1303.13 and 1315.13, upon consideration 
of the relevant factors, the Acting 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 Acting Administrator will issue and 
publish in the Federal Register a final order establishing the 2021 
aggregate production quotas for controlled substances in schedule I and 
II and establishing an assessment of annual needs for the list I 
chemicals ephedrine, pseudoephedrine, and phenylpropanolamine, 21 CFR 
1303.11(c) and 1315.11(f).

Timothy J. Shea,
Acting Administrator.
[FR Doc. 2020-19285 Filed 8-31-20; 8:45 am]
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