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 2020, 48170-48177 [2019-19785]

Agencies

• Drug Enforcement Administration
• Department of Justice

[Federal Register Volume 84, Number 177 (Thursday, September 12, 2019)]
[Notices]
[Pages 48170-48177]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2019-19785]


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DEPARTMENT OF JUSTICE

Drug Enforcement Administration

[Docket No. DEA-508P]


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 2020

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 2020 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 15, 2019. Commenters should be aware that the electronic 
Federal Docket Management System will not accept comments after 11:59 
p.m. Eastern Time on the last day of the comment period.
    Based on comments received in response to this notice, the 
Administrator may hold a public hearing on one or more issues raised. 
In the event the Administrator decides in his sole discretion to hold 
such a hearing, the Administrator will publish a notice of any such 
hearing in the Federal Register. After consideration of any comments or 
objections, or after a hearing, if one is held, the Administrator will 
publish in the Federal Register a final order establishing the 2020 
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-508P'' on all correspondence, including any 
attachments. The Drug Enforcement Administration encourages that all 
comments be submitted electronically through the Federal eRulemaking 
Portal which provides the ability to type short comments directly into 
the comment field on the web page or attach a file for lengthier 
comments. Please go to 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, Diversion Control 
Division, Drug Enforcement Administration; Mailing Address: 8701 
Morrissette Drive, Springfield, Virginia 22152, Telephone: (202) 598-
6812.

SUPPLEMENTARY INFORMATION:

Posting of Public Comments

    Please note that all comments received in response to this docket 
are considered part of the public record. They will, unless reasonable 
cause is given, be made available by the Drug Enforcement 
Administration (DEA) for public inspection online at 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

[[Page 48171]]

INFORMATION'' in the first paragraph of your comment. You must also 
place all the personal identifying information you do not want made 
publicly available in the first paragraph of your comment and identify 
what information you want redacted.
    If you want to submit confidential business information as part of 
your comment, but do not want it to be made publicly available, you 
must include the phrase ``CONFIDENTIAL BUSINESS INFORMATION'' in the 
first paragraph of your comment. You must also prominently identify 
confidential business information to be redacted within the comment.
    Comments containing personal identifying information or 
confidential business information identified and located as directed 
above will generally be made available in redacted form. If a comment 
contains so much confidential business information or personal 
identifying information that it cannot be effectively redacted, all or 
part of that comment may not be made publicly available. Comments 
posted to 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 2020 Aggregate Production Quotas and Assessment 
of Annual Needs

    The proposed year 2020 aggregate production quotas and assessment 
of annual needs represent those quantities of schedule I and II 
controlled substances, and the list I chemicals ephedrine, 
pseudoephedrine, and phenylpropanolamine, to be manufactured in the 
United States in 2020 to provide for the estimated medical, scientific, 
research, and industrial needs of the United States, lawful export 
requirements, and the establishment and maintenance of reserve stocks. 
These quotas include imports of ephedrine, pseudoephedrine, and 
phenylpropanolamine, but do not include imports of controlled 
substances for use in industrial processes.
    In determining the proposed 2020 aggregate production quotas and 
assessment of annual needs, the Acting Administrator has taken into 
account the criteria of 21 U.S.C. 826(a) and 21 CFR 1303.11 (aggregate 
production quotas for controlled substances) and 21 CFR 1315.11 
(assessment of annual needs for ephedrine, pseudoephedrine, and 
phenylpropanolamine).

Recent Changes to the Law and Regulations Governing Quotas

    It should be noted that, as a result of new laws and regulations, 
the factors that DEA considers in setting aggregate production quotas 
have changed. First, under DEA's regulations as amended effective 
August 15, 2018 (83 FR 32784), when setting an aggregate production 
quota for any basic class of controlled substance listed in schedule I 
or II, DEA must now consider (in addition to the previously existing 
regulatory factors): (i) ``[t]he extent of any diversion of the 
controlled substance in the class,'' and (ii) ``[r]elevant information 
obtained from the Department of Health and Human Services [HHS], 
including from the Food and Drug Administration [FDA], the Centers for 
Disease Control [CDC], and the Centers for Medicare and Medicaid 
Services [CMS], and relevant information obtained from the states.''
    As a result, DEA regulations now list the following factors that 
the Administrator must consider in determining the aggregate production 
quotas: (1) Total net disposal of each class or chemical by all 
manufacturers and chemical importers during the current and two 
preceding years; (2) trends in the national rate of net disposal of the 
class or chemical; (3) total actual (or estimated) inventories of the 
class or chemical and of all substances manufactured from the class or 
chemical, and trends in inventory accumulation; (4) projected demand 
for each class or chemical as indicated by procurement and import 
quotas requested in accordance with 21 CFR 1303.12, 1315.32, and 
1315.34; (5) the extent of any diversion of the controlled substance in 
the class; (6) relevant information obtained from HHS, including from 
the FDA, CDC, and CMS, and relevant information obtained from the 
states; and (7) other factors affecting medical, scientific, research, 
and industrial needs of the United States and lawful export 
requirements, as the Acting 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 
1303.11(b). These quotas do not include imports of controlled 
substances for use in industrial processes.
    In addition to the foregoing regulatory changes, on October 24, 
2018, the President signed into law the Substance Use-Disorder 
Prevention that Promotes Opioid Recovery and Treatment for Patients and 
Communities Act (SUPPORT Act), Pub. L. 115-271, 132 Stat. 3894. The 
SUPPORT Act, which became effective upon its enactment, changed the way 
DEA must establish quotas with respect to five controlled substances: 
fentanyl, oxycodone, hydrocodone, oxymorphone, and hydromorphone. These 
five substances are referred to in the statute as ``covered controlled 
substances.'' The new law specifically provides that in establishing 
any quota under 21 U.S.C. 826, DEA is required to ``estimate the amount 
of diversion of the covered controlled substance that occurs in the 
United States'' and ``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).
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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).
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    The SUPPORT Act further states: ``In estimating diversion under 
this paragraph, the [Administrator] shall consider information the 
[Administrator], in consultation with the Secretary of [HHS], 
determines reliable on rates of overdose deaths and abuse and overall 
public health impact related to the covered controlled substance in the 
United States; and (ii) may take into consideration whatever other 
sources of information the [Administrator] determines reliable. \2\ Id.
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    \2\ DEA intends to propose amendments to the Agency's 
regulations that will implement the amendments to the CSA made by 
the SUPPORT Act. Although these amendments to the regulations have 
not yet been issued, the statutory requirements stated above became 
effective upon enactment of the SUPPORT Act, and DEA is therefore 
obligated to adhere to them in issuing these proposed aggregate 
production quotas.
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Information Considered by DEA in Evaluating the Factors

    For the factors listed in 21 CFR 1303.11(b)(1) and (2), the DEA 
solicited information from the FDA. In May 2019,

[[Page 48172]]

DEA received FDA estimates of legitimate medical need for calendar 
years 2019 and 2020, as required by the statutes of both agencies. See 
21 U.S.C. 826 and 42 U.S.C. 242. 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 2018 were extracted from several DEA 
supported databases. As a result of considering the extent of 
diversion, DEA notes that the quantity of FDA-approved drug products 
that correlate to controlled substances in 2018 represents less than 
one percent of the total quantity of controlled substances distributed 
to retail purchasers. 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), 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 DEA was able to identify usable information contained in the 
databases noted above. 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).
    DEA's internal Automated Reports and Consolidated Ordering System 
(ARCOS) database was considered as well, however it was determined to 
contain identical information to the Theft Loss Report database because 
both are registrant reported databases, and therefore it was excluded. 
Additionally, both the National Seizure System (NSS) and the National 
Forensic Laboratory Information System (NFLIS) databases were reviewed. 
The NSS and NFLIS data reports included total seized weight without 
reference to whether it is finished dosage forms, container weight, 
tablets or pill weight; provides no reference to specific API 
concentrations; and the databases do not distinguish between 
pharmaceutically and illicitly manufactured controlled substances.
    Because of factor six in 21 CFR 1303.11(b), DEA formally solicited 
HHS, CDC, CMS, and the states in August 2018, requesting information 
including rates of overdose deaths and abuse and overall public health 
impact related to controlled substances. This information was also 
considered pursuant to the SUPPORT Act. Based on the level of response, 
DEA sent a second letter to the states in October 2018. DEA sent a 
second letter to the CDC in April 2019 and CDC responded in June 2019. 
DEA in consultation with HHS and CDC discussed the requirements under 
the SUPPORT Act in June 2019.
    As a result of these solicitations, DEA received Medicaid sales 
data from CMS, and drug overdose and death data from the CDC and seven 
state attorneys general. The CMS data consisted of aggregated sales of 
controlled substances to Medicaid patients. This information could not 
be used in determining diversion and therefore was not used in setting 
the aggregate production quotas. The CDC and HHS do not have diversion 
data by individual controlled substance, but did provide documents and 
links to data sets and scholarly articles containing overdose and death 
rates at the national level. DEA determined that the current data could 
not be used to estimate diversion for the purpose of setting the 
aggregate production quotas. One major drawback is that the data does 
not examine each controlled substance individually (i.e. as a basic 
class and the quantity ingested), but groups them together chemically, 
making it difficult to determine which basic class was involved and to 
what extent its aggregate production quotas should be lowered. For 
example, patients that overdose from hydrocodone, oxycodone, or 
hydromorphone are grouped together under opioid-related overdose. DEA 
is unable to determine the basic class that led to the overdose from 
this information. Additionally, DEA cannot determine from the data if 
the patient overdosed on an illicit opioid or an FDA-approved opioid 
product. For purposes of setting the aggregate production quotas for 
each basic class of controlled substance, DEA would benefit more from 
the drug overdose and mortality data if it precisely identified the 
controlled substance(s) believed to be the cause of overdose or death 
and if it included the quantity of the substance ingested. DEA and HHS 
are working together to determine if this data currently exists in any 
reliable databases.
    Nine state attorneys general responded to the DEA's request for 
information. Seven provided, in general, prescription data (from 
prescription drug monitoring programs), overdose and death rate data, 
in addition to statements regarding the over prescription of opioid 
medications and its effect on public health. The other states were not 
able to or did not provide the requested data. DEA examined the 
information submitted and determined that it is too generalized to use 
in estimating diversion because the controlled substances are grouped 
together chemically. Toxicity reports, moreover, show all the drugs in 
a patient's system when arriving at the hospital or emergency room, 
which makes it difficult to know how much and which drug is responsible 
for the visit and consequently adjust its individual aggregate 
production quota. Additionally, there is no way to determine if the 
substance was manufactured illicitly or was an FDA-approved drug 
product. The manufacturing of illicit substances is not considered when 
determining the aggregate production quotas because such illicit 
manufacturing cannot be tempered by adjusting the aggregate production 
quotas. The information provided is highly valuable to understanding 
the impact of substance use, misuse, and abuse on the public health, 
but in its current form is not usable for the aggregate production 
quota analysis. Other factors the Acting Administrator considered in 
calculating the aggregate production quotas, but not the assessment of 
annual needs, include product development requirements of both bulk and 
finished dosage form

[[Page 48173]]

manufacturers, and other pertinent information. In determining the 
proposed 2020 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).

Estimates of Diversion Pursuant to the SUPPORT Act

    To estimate diversion as is required by the SUPPORT Act, DEA 
aggregated the API of each covered controlled substance by metric 
weight where the data was available in the aforementioned databases. 
Based on the individual entries into the aforementioned databases, 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.

                      Diversion Estimates for 2018
                                  [kg]
------------------------------------------------------------------------
 
------------------------------------------------------------------------
Fentanyl.....................................................      0.109
Hydrocodone..................................................     24.259
Hydromorphone................................................      1.219
Oxycodone....................................................     57.051
Oxymorphone..................................................      1.157
------------------------------------------------------------------------

    In accordance with the SUPPORT Act, after estimating the amount of 
diversion for the foregoing five controlled substances, DEA made 
reductions to the individual aggregate production quotas for each 
covered controlled substance by the corresponding quantities listed in 
the table.
    The SUPPORT Act mandates that DEA, in consultation with HHS, 
determine reliable rates of overdose deaths, abuse, and overall public 
health impact as a factor of diversion to make appropriate quota 
reductions for each of the covered controlled substances. During the 
June 2019 consult with HHS, it was determined that the current 
available data regarding rates of overdose deaths and public health 
impact does not reflect each controlled substance individually (i.e. as 
a basic class and the quantity ingested), but groups them together 
functionally (opioid or psychostimulant), without regard to illicit or 
licit manufacturing. Without specificity to basic class and whether the 
substance was lawfully manufactured, DEA is unable to determine the 
basic class that led to the overdose from this information. 
Additionally, DEA cannot determine from the data if the patient 
overdosed on an illicit opioid or an FDA approved opioid product. As 
such, the number of overdose deaths resulting from fentanyl, oxycodone, 
hydrocodone, hydromorphone, and oxymorphone diverted from legitimate 
sources is unknown.
    As discussed above, DEA considers the extent of diversion of all 
controlled substances and estimates diversion of covered controlled 
substances, as is required by the recent amendments to the CSA and 
changes to DEA's own regulations. The information maintained in the 
various DEA databases discussed above assists the agency in identifying 
some forms of diversion of controlled substances. DEA is committed to 
improving its ability to account for other types of diversion.
    The Acting Administrator, therefore, proposes to establish the 2020 
aggregate production quotas for certain schedule I and II controlled 
substances and assessment of annual needs for the list I chemicals 
ephedrine, pseudoephedrine, and phenylpropanolamine, expressed in grams 
of anhydrous acid or base, as follows:

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                                                         Proposed  2020
                     Basic class                           quotas (g)
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                               Schedule I
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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-                30
 2)..................................................
2-[4-(Isopropylthio)-2,5-dimethoxyphenyl]ethanamine                   30
 (2C-T-4)............................................
3,4,5-Trimethoxyamphetamine..........................                 30
3,4-Methylenedioxyamphetamine (MDA)..................                 55
3,4-Methylenedioxymethamphetamine (MDMA).............                 50
3,4-Methylenedioxy-N-ethylamphetamine (MDEA).........                 40
3,4-Methylenedioxy-N-methylcathinone (methylone).....                 40
3,4-Methylenedioxypyrovalerone (MDPV)................                 35

[[Page 48174]]

 
3-FMC; 3-Fluoro-N-methylcathinone....................                 25
3-Methylfentanyl.....................................                 30
3-Methylthiofentanyl.................................                 30
4-Bromo-2,5-dimethoxyamphetamine (DOB)...............                 30
4-Bromo-2,5-dimethoxyphenethylamine (2-CB)...........                 25
4CN-Cumyl-Butanica, 1-(4-Cyanobutyl)-N-(2-                            25
 phenylpropan-2-yl)-1H-indazole-3-carboximide........
4-Fluoroisobutyryl fentanyl..........................                 30
4-FMC; Flephedrone...................................                 25
4-MEC; 4-Methyl-N-ethylcathinone.....................                 25
4-Methoxyamphetamine.................................                150
4-Methyl-2,5-dimethoxyamphetamine (DOM)..............                 25
4-Methylaminorex.....................................                 25
4-Methyl-N-methylcathinone (mephedrone)..............                 45
4-Methyl-[alpha]-pyrrolidinopropiophenone (4-MePPP)..                 25
5-(1,1-Dimethylheptyl)-2-[(1R,3S)-3-                                  50
 hydroxycyclohexyl]-phenol...........................
5-(1,1-Dimethyloctyl)-2-[(1R,3S)-3-hydroxycyclohexyl]-                40
 phenol (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-                 25
 (5-fluoropentyl)-1H-indazole-3-carboxamide..........
5F-CUMYL-P7AICA; (1-(5-fluoropentyl)-N-(2-                            25
 phenylpropan-2-yl)-1H-pyrrolo[2,3-b]pyridine-3-
 carboximide)........................................
5F-ADB; 5F-MDMB-PINACA (methyl 2-(1-(5-fluoropentyl)-                 30
 1H-indazole-3-carboxamido)-3,3-dimethylbutanoate)...
5F-AMB (methyl 2-(1-(5-fluoropentyl)-1H-indazole-3-                   30
 carboxamido)-3-methylbutanoate).....................
5F-APINACA; 5F-AKB48 (N-(adamantan-1-yl)-1-(5-                        30
 fluoropentyl)-1H-indazole-3-carboxamide)............
5-Fluoro-PB-22; 5F-PB-22.............................                 20
5-Fluoro-UR144, XLR11 ([1-(5-fluoro-pentyl)-1H-indol-                 25
3-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-                   30
 yl)-1-(4-fluorobenzyl)-1H-indazole-3-carboxamide)...
Acetorphine..........................................                 25
Acetyl Fentanyl......................................                100
Acetyl-alpha-methylfentanyl..........................                 30
Acetyldihydrocodeine.................................                 30
Acetylmethadol.......................................                  2
Acryl Fentanyl.......................................                 25
ADB-PINACA (N-(1-amino-3,3-dimethyl-1-oxobutan-2-yl)-                 50
 1-pentyl-1H-indazole-3-carboxamide).................
AH-7921..............................................                 30
Allylprodine.........................................                  2
Alphacetylmethadol...................................                  2
alpha-Ethyltryptamine................................                 25
Alphameprodine.......................................                  2
Alphamethadol........................................                  2
Alphaprodine.........................................                 25
alpha-Methylfentanyl.................................                 30
alpha-Methylthiofentanyl.............................                 30
alpha-Methyltryptamine (AMT).........................                 25
alpha-Pyrrolidinobutiophenone ([alpha]-PBP)..........                 25
alpha-Pyrrolidinopentiophenone ([alpha]-PVP).........                 25
Aminorex.............................................                 25
Anileridine..........................................                 20
APINCA, AKB48 (N-(1-adamantyl)-1-pentyl-1H-indazole-3-                25
 carboxamide)........................................
Benzethidine.........................................                 25
Benzylmorphine.......................................                 30
Betacetylmethadol....................................                  2
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

[[Page 48175]]

 
Codeine-N-oxide......................................                192
Cyclopentyl Fentanyl.................................                 30
Cyclopropyl Fentanyl.................................                 20
Cyprenorphine........................................                 25
Desomorphine.........................................                 25
Dextromoramide.......................................                 25
Diapromide...........................................                 20
Diethylthiambutene...................................                 20
Diethyltryptamine....................................                 25
Difenoxin............................................              9,200
Dihydromorphine......................................            753,500
Dimenoxadol..........................................                 25
Dimepheptanol........................................                 25
Dimethylthiambutene..................................                 20
Dimethyltryptamine...................................                 50
Dioxyaphetyl butyrate................................                 25
Dipipanone...........................................                  5
Drotebanol...........................................                 25
Ethylmethylthiambutene...............................                 25
Etorphine............................................                 30
Fenethylline.........................................                 30
Fentanyl related substances..........................                 40
FUB-144..............................................                 25
FUB-AKB48............................................                 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-                             35
 naphthoyl)indole)...................................
JWH-203 (1-Pentyl-3-(2-chlorophenylacetyl)indole)....                 30
JWH-250 (1-Pentyl-3-(2-methoxyphenylacetyl)indole)...                 30
JWH-398 (1-Pentyl-3-(4-chloro-1-naphthoyl)indole)....                 30
Ketobemidone.........................................                 30
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-                                30
 (cyclohexylmethyl)-1H-indole-3-carboxamido)-3,3-
 dimethylbutanoate)..................................
MDMB-FUBINACA (methyl 2-(1-(4-fluorobenzyl)-1H-                       30
 indazole-3-carboxamido)-3,3-dimethylbutanoate)......
MMB-CHMICA-(AMB-CHMICA); Methyl-2-(1-                                 25
 (cyclohexylmethyl)-1H-indole-3-carboxamido)-3-
 methylbutanoate.....................................
Marihuana............................................          3,200,000
Mecloqualone.........................................                 30
Mescaline............................................                 25
Methaqualone.........................................                 60
Methcathinone........................................                 25
Methyoxyacetyl 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-                 25
 3-carboxylate.......................................
N,N-Dimethylamphetamine..............................                 25
Naphyrone............................................                 25
N-Ethyl-1-phenylcyclohexylamine......................                  5
N-Ethyl-3-piperidyl benzilate........................                 10
N-Ethylamphetamine...................................                 24
N-Ethylpentylone, ephylone...........................                 30

[[Page 48176]]

 
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)-                             30
 benzoyl]indole).....................................
Tetrahydrocannabinols................................            384,460
Tetrahydrofuranyl fentanyl...........................                 15
Thebacon.............................................                 25
Thiafentanil.........................................                 25
Thiofentanyl.........................................                 25
THJ-2201 ( [1-(5-fluoropentyl)-1H-indazol-3-                          30
 yl](naphthalen-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)............            813,005
Alfentanil...........................................              3,260
Alphaprodine.........................................                  2
Amobarbital..........................................             20,100
Amphetamine (for conversion).........................         14,137,578
Amphetamine (for sale)...............................         42,400,000
Bezitramide..........................................                 25
Carfentanil..........................................                 20
Cocaine..............................................             82,127
Codeine (for conversion).............................          3,225,000
Codeine (for sale)...................................         30,731,558
Dextropropoxyphene...................................                 35
Dihydrocodeine.......................................            156,713
Dihydroetorphine.....................................                  2
Diphenoxylate (for conversion).......................             14,100
Diphenoxylate (for sale).............................            770,800
Ecgonine.............................................             88,134
Ethylmorphine........................................                 30
Etorphine hydrochloride..............................                 32
Fentanyl.............................................            813,005
Glutethimide.........................................                 25
Hydrocodone (for conversion).........................              1,250

[[Page 48177]]

 
Hydrocodone (for sale)...............................         34,836,854
Hydromorphone........................................          3,054,479
Isomethadone.........................................                 30
Levo-alphacetylmethadol (LAAM).......................                  5
Levomethorphan.......................................                 30
Levorphanol..........................................             38,000
Lisdexamfetamine.....................................         21,000,000
Meperidine...........................................          1,463,873
Meperidine Intermediate-A............................                 30
Meperidine Intermediate-B............................                 30
Meperidine Intermediate-C............................                 30
Metazocine...........................................                 15
Methadone (for sale).................................         22,278,000
Methadone Intermediate...............................         24,064,000
Methamphetamine......................................          1,213,603
------------------------------------------------------------------------
[678,878 grams of levo-desoxyephedrine for use in a non-controlled, non-
   prescription product; 505,231 grams for methamphetamine mostly for
       conversion to a schedule III product; and 29,494 grams for
                       methamphetamine (for sale)]
------------------------------------------------------------------------
Methylphenidate......................................         57,438,334
Metopon..............................................                 25
Moramide-intermediate................................                 25
Morphine (for conversion)............................          4,089,000
Morphine (for sale)..................................         29,353,655
Nabilone.............................................             62,000
Noroxymorphone (for conversion)......................         19,169,340
Noroxymorphone (for sale)............................            376,000
Opium (powder).......................................            250,000
Opium (tincture).....................................            530,837
Oripavine............................................         28,705,000
Oxycodone (for conversion)...........................            914,010
Oxycodone (for sale).................................         72,593,983
Oxymorphone (for conversion).........................         24,525,540
Oxymorphone (for sale)...............................          1,290,051
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.............................................         70,829,235
------------------------------------------------------------------------
                            List I Chemicals
------------------------------------------------------------------------
Ephedrine (for conversion)...........................                 25
Ephedrine (for sale).................................          4,136,000
Phenylpropanolamine (for conversion).................         14,100,000
Phenylpropanolamine (for sale).......................          7,990,000
Pseudoephedrine (for conversion).....................              1,000
Pseudoephedrine (for sale)...........................        174,246,000
------------------------------------------------------------------------

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

Conclusion

    After consideration of any comments or objections, or after a 
hearing, if one is held, the Acting Administrator will issue and 
publish in the Federal Register a final order establishing the 2020 
aggregate production quota for controlled substances in schedules I and 
II and establishing an assessment of annual needs for the list I 
chemicals ephedrine, pseudoephedrine, and phenylpropanolamine, 21 CFR 
1303.11(c) and 1315.11(f).

    Dated: September 6, 2019.
Uttam Dhillon,
Acting Administrator.
[FR Doc. 2019-19785 Filed 9-11-19; 8:45 am]
BILLING CODE 4410-09-P