67348 Federal Register / Vol. 83, No. 248 / Friday, December 28, 2018 / Notices 

inspection at the Office of the Secretary 

and on EDIS. 

The authority for the Commission’s 

determination is contained in section 

337 of the Tariff Act of 1930, as 

amended (19 U.S.C. 1337), and in part 

210 of the Commission’s Rules of 

Practice and Procedure (19 CFR part 

210). 

By order of the Commission. 

Issued: December 20, 2018. 

Lisa Barton, 

Secretary to the Commission. 

[FR Doc. 2018–28175 Filed 12–27–18; 8:45 am] 

BILLING CODE 7020–02–P 

JUDICIAL CONFERENCE OF THE 

UNITED STATES 

Hearing of the Judicial Conference 

Advisory Committee on the Federal 

Rules of Evidence 

AGENCY: The Advisory Committee on 

the Federal Rules of Evidence, Judicial 

Conference of the United States. 

ACTION: Notice of cancellation of public 

hearing. 

SUMMARY: The January 18, 2019 public 

hearing in Washington, DC, on proposed 

amendments to the Evidence Rules has 

been canceled. 

FOR FURTHER INFORMATION CONTACT: 

Rebecca A. Womeldorf, Rules 

Committee Secretary, Rules Committee 

Staff, Administrative Office of the 

United States Courts, Washington, DC 

20544, telephone (202) 502–1820. 

SUPPLEMENTARY INFORMATION: 

Announcements for this hearing were 

previously published in 83 FR 39463 

and 83 FR44305. 

Dated: December 20, 2018. 

Rebecca A. Womeldorf, 

Rules Committee Secretary. 

[FR Doc. 2018–28160 Filed 12–27–18; 8:45 am] 

BILLING CODE 2210–55–P 

DEPARTMENT OF JUSTICE 

Drug Enforcement Administration 

[Docket No. DEA–488E] 

Established Aggregate Production 

Quotas for Schedule I and II Controlled 

Substances and Assessment of 

Annual Needs for the List I Chemicals 

Ephedrine, Pseudoephedrine, and 

Phenylpropanolamine for 2019 

AGENCY: Drug Enforcement 

Administration, Department of Justice. 

ACTION: Final order. 

SUMMARY: This final order establishes 

the initial 2019 aggregate production 

quotas for controlled substances in 

schedules I and II of the Controlled 

Substances Act and the assessment of 

annual needs for the list I chemicals 

ephedrine, pseudoephedrine, and 

phenylpropanolamine. 

DATES: Valid December 28, 2018. 

FOR FURTHER INFORMATION CONTACT: 

Kathy L. Federico, Regulatory Drafting 

and Policy Support Section (DPW), 

Diversion Control Division, Drug 

Enforcement Administration, 8701 

Morrissette Drive, Springfield, VA 

22152, Telephone: (202) 598–6812. 

SUPPLEMENTARY INFORMATION: 

Legal Authority 

Section 306 of the Controlled 

Substances Act (CSA) (21 U.S.C. 826) 

requires the Attorney General to 

establish aggregate production quotas 

for each basic class of controlled 

substance listed in schedules I and II 

and for the list I chemicals ephedrine, 

pseudoephedrine, and 

phenylpropanolamine. The Attorney 

General has delegated this function to 

the Administrator of the DEA pursuant 

to 28 CFR 0.100. 

Background 

The 2019 aggregate production quotas 

and assessment of annual needs 

represent those quantities of schedule I 

and II controlled substances and the list 

I chemicals ephedrine, 

pseudoephedrine, and 

phenylpropanolamine that may be 

manufactured in the United States in 

2019 to provide for the estimated 

medical, scientific, research, and 

industrial needs of the United States, for 

lawful export requirements, and for the 

establishment and maintenance of 

reserve stocks. These quotas include 

imports of ephedrine, pseudoephedrine, 

and phenylpropanolamine, but do not 

include imports of controlled 

substances for use in industrial 

processes. 

On August 20, 2018, the DEA 

published a notice titled ‘‘Proposed 

Aggregate Production Quotas for 

Schedule I and II Controlled Substances 

and Assessment of Annual Needs for the 

List I Chemicals Ephedrine, 

Pseudoephedrine, and 

Phenylpropanolamine for 2019’’ in the 

Federal Register. 83 FR 42164. This 

notice proposed the 2019 aggregate 

production quotas for each basic class of 

controlled substance listed in schedules 

I and II and the 2019 assessment of 

annual needs for the list I chemicals 

ephedrine, pseudoephedrine, and 

phenylpropanolamine. All interested 

persons were invited to comment on or 

object to the proposed aggregate 

production quotas and the proposed 

assessment of annual needs on or before 

September 19, 2018. 

Comments Received 

The DEA received 48 comments from 

professional organizations, patients, 

associations, universities, Senators, 

State Attorneys General, a doctor, DEA 

registered entities, and non-DEA 

entities. The comments included 

concerns about the quota process, 

shortages, prescriptions, diversion, 

marihuana, requests for a hearing, 

requests for increase in specific 

production quotas, and other comments 

that are outside the scope of the notice. 

Quota Process 

There were eight commenters that 

expressed concerns about the quota 

process. Some of these commenters 

requested that the DEA consider 

information from the Department of 

Health and Human Services (HHS) and 

the Food and Drug Administration 

(FDA) to determine the aggregate 

production quota. Other commenters 

stated that the DEA did not consider the 

factors contained in the Controlled 

Substances Quotas Final Rule published 

on July 16, 2018, 83 FR 32784, to 

determine the 2019 aggregate 

production quota. 

The DEA has obtained and considered 

relevant information from the FDA. The 

information the DEA received included 

the observed and estimated domestic 

usage of 26 schedule II controlled 

substances, new drug applications and 

abbreviated drug application approvals, 

and clinical trials for schedule I and II 

controlled substances. 

Regarding the Final Rule published 

on July 16, 2018, 83 FR 32784, the DEA 

amended the factors set forth in 21 CFR 

1303.11 to be considered when setting 

the aggregate production quotas to 

include the extent of diversion of the 

controlled substances in each class, and 

relevant information obtained from the 

HHS, the FDA, the Centers for Disease 

Control and Prevention (CDC), the 

Centers for Medicare and Medicaid 

Services (CMS), and the states. 

The DEA has solicited the states and 

federal partners to obtain relevant 

information to be considered when 

setting the aggregate production quota 

pursuant to 21 CFR 1303.11 and this 

information will be considered for the 

2019 proposed adjustments to the 

aggregate production quota. The DEA 

will continue to solicit information from 

the states for the 2020 aggregate 

production quotas and the years to 

follow. 


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However, the DEA is obligated to 

issue individual production and 

procurement quotas sufficiently in 

advance of the upcoming year to allow 

manufacturers to prepare for the 

legitimate needs of the United States. 

The DEA may not issue individual 

production and procurement quotas 

until the aggregate production quotas 

have been established. As a result of 

these obligations under the CSA, the 

DEA was not able to obtain and consider 

the amended factors set forth in Final 

Rule, 83 FR 32784, for the purpose of 

issuing the 2019 proposed aggregate 

production quota. 

The DEA has a fluid process for 

setting quotas which allows the agency 

to make necessary quota adjustments. 

The process involves setting the 

proposed aggregate production quotas 

for a calendar year, and, following the 

review of any comments, the issuance of 

a Final Order to establish the aggregate 

production quota. Later in the process, 

the DEA issues a Proposed Adjustment 

to the aggregate production quota, and 

following the review of any comments, 

DEA issues a final order setting the 

Final Adjusted Aggregate Production 

Quotas. The DEA will consider the 

additional information received in the 

course of preparing proposed 

amendments and the final 2019 adjusted 

aggregate production quota. 

Shortages 

There were 28 commenters that 

expressed concerns about the decrease 

in certain aggregate production quotas. 

These commenters alleged that 

decreases to the aggregate production 

quotas have resulted in a shortage of 

injectable opioid medications and 

interfere with the treatment of patients. 

Some of these commenters also 

suggested that the DEA separate quotas 

for solid oral controlled substances and 

injectable controlled substances, and 

that DEA allow consideration by 

individual pharmaceutical dosage 

forms. 

The DEA is committed to ensuring an 

adequate and uninterrupted supply of 

controlled substances in order to meet 

legitimate medical, scientific, and 

export needs of the United States. 

Although the DEA sets the aggregate 

production quota, it is possible that 

manufacturers’ business practices may 

lead to a shortage of controlled 

substances at the consumer level, 

despite the adequacy of the aggregate 

production quota set by DEA. The 

aggregate production quotas are set by 

the DEA in a manner to include both 

injectable opioids and solid oral opioids 

in order to ensure that the estimated 

medical needs of the United States are 

met. 

Notably, at the time of the proposed 

aggregate production quota, 21 U.S.C. 

826(a) provided that ‘‘production quotas 

shall be established in terms of 

quantities of each basic class of 

controlled substance and not in terms of 

individual pharmaceutical dosage forms 

prepared from or containing such a 

controlled substance.’’ On October 24, 

2018, the President signed into law the 

SUPPORT for Patients and Communities 

Act of 2018, (Pub. L. 115–271), which 

now allows but does not require the 

DEA to grant quotas in terms of dosage 

forms if the agency determines that 

doing so will assist in avoiding the 

overproduction, shortages, or diversion 

of a controlled substance. DEA will be 

evaluating these issues over time. 

Furthermore, the DEA and the FDA 

can coordinate efforts to prevent or 

alleviate drug shortages pursuant to 21 

U.S.C. 826a(2). For example, the 

asserted domestic shortage of injectable 

controlled substances was alleviated 

through the FDA and the DEA 

collaboration to get specific injectable 

controlled substances imported into the 

United States. 

Transparency 

Two Senators submitted a joint 

comment supporting the DEA’s efforts 

to address the opioid crisis, but 

expressed concerns that the aggregate 

production quota for schedule II opioids 

remains too high. These commenters 

also requested a transparent explanation 

of the analysis and specific 

considerations that the DEA considered 

when establishing the 2019 quotas for 

schedule II opioids. 

The DEA continues to address the 

opioid crisis through initiatives such as 

the President’s Safer Prescribing Plan, 

which seeks to reduce nationwide 

opioid prescription fills by one-third 

within three years. The DEA has 

observed a decline in the number of 

prescriptions written for schedule II 

opioids since 2014 and will continue to 

set aggregate production quotas to meet 

the medical needs of the United States 

while combating the opioid crisis. 

In determining the aggregate 

production quota, the DEA took into 

account the data regarding the number 

of prescriptions that have been issued 

and an analysis of the factors as then set 

forth in 21 CFR 1303.11. The specific 

information that was obtained and 

considered included an analysis of sales 

data from databases such as Automation 

of Reports and Consolidated Orders 

System (ARCOS) and IQVIA; in addition 

to FDA forecasts and projections, 

historical total market sales data, 

products entering and exiting the 

market, expected product development, 

expected exports, inventory data, theft 

and loss data, and company forecasts. 

As a result, the final aggregate 

production quota for several opioids are 

decreased from the proposed initial 

2019 levels. These decreases take into 

account the combined efforts of the the 

DEA, the FDA, and the CDC enforcing 

regulations and issuing guidance 

documents as well as many states 

enacting prescription monitoring 

database programs to stem the opiate/ 

opioid epidemic. 

Quotas and Prescriptions 

Eleven State Attorneys General 

submitted a joint comment recognizing 

DEA’s efforts to combat the opioid 

epidemic and expressed concerns about 

excessive quotas for opioids. These 

commenters also expressed concerns 

about overprescribing and referenced 

various studies. The referenced material 

cited in these comments also discuss 

patients who divert their prescriptions 

by sharing their prescriptions with 

others. 

The DEA continues to address the 

opioid crisis through laws, regulations, 

and initiatives such as the Safer 

Prescribing Plan. The Safer Prescribing 

Plan seeks to reduce nationwide opioid 

prescription fills by one-third within 

three years. The DEA has observed a 

decline for certain prescriptions written 

for schedule II opioids since 2014 which 

can be attributed to federal and state 

government activities and interventions, 

including the implementation of 

Prescription Drug Monitoring Programs, 

enforcement of current regulations, and 

guidance documents such as the CDC 

Guidelines for Prescribing Opioids for 

Chronic Pain—United States, March 

2016. The DEA will continue to address 

the opioid crisis while ensuring an 

adequate and uninterrupted supply of 

controlled substances in order to meet 

the demand of legitimate medical, 

scientific, and export needs of the 

United States. 

The DEA sets aggregate production 

quotas in a manner to ensure that all 

prescriptions that are authorized for 

legitimate medical purposes can be 

filled. Prescribers who are authorized to 

dispense controlled substances are 

responsible for adhering to the laws and 

regulations set forth under the CSA, 

which requires doctors to only write 

prescriptions for legitimate medical 

needs. Any practitioner issuing an 

invalid prescription for controlled 

substances and any pharmacy filling 

such a prescription would be in 

violation of the CSA. 


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Upon review of the studies, DEA has 

determined that they are insufficient to 

support a reduction in the aggregate 

production quotas. The studies have 

found, with respect to a variety of 

medical procedures, that physicians 

prescribe more controlled substances for 

post-operative pain than the patients 

utilize. However, the DEA has 

concluded that while the referenced 

studies are concerning, they are 

insufficient to support a determination 

as to the level of overprescribing that 

occurs across the range of the medical 

procedures that are performed each year 

on a national basis. 

Including Diversion in Quotas 

Eleven State Attorneys General and 

three other commenters expressed 

concerns about DEA’s ability to account 

for diversion when setting the aggregate 

production quotas. 

The factors that DEA considers in 

setting the aggregate production quotas 

were amended in a Final Rule published 

on July 16, 2018, 83 FR 32784, to 

include the extent of any diversion of 

the controlled substances in the class, 

which will strengthen DEA’s ability to 

reduce the likelihood of the diversion of 

controlled substances. When setting the 

established aggregate production quota, 

the DEA accounted for diversion by 

analyzing information such as, reports 

of controlled substance thefts and 

losses, and seizure data that are 

captured through internal DEA 

databases and will continue to do so 

when setting future aggregate 

production quotas. The DEA will also 

consider information obtained from 

CMS, CDC, FDA, and the states which 

may include diversion data to be 

considered for the adjusted aggregate 

production quota. 

Marihuana 

Seven commenters expressed their 

support for the increase in the 

production quota of marihuana. Three 

of those commenters expressed 

concerns about approval of applications 

for registration to manufacture (grow) 

marihuana. The DEA increased the 

production quota for marihuana based 

solely on increased usage projections for 

federally approved research projects. 

The DEA continues to review 

applications for registration and 

registers the number of bulk 

manufacturers of a controlled substance 

that is necessary to produce an adequate 

and uninterrupted supply. 

Hearings 

Two commenters urged DEA to hold 

a public hearing. One of the commenters 

stated that the DEA should have a 

hearing to gather stakeholder feedback 

on how the DEA can help address the 

opioid epidemic while ensuring an 

adequate supply of opioids for clinically 

appropriate care. The second 

commenter stated that the DEA should 

hold a hearing to enable stakeholders to 

express their views about the proposed 

reductions. 

Under the DEA regulations, the 

decision of whether to grant this type of 

a hearing on the issues raised by the 

commenters lies solely within the 

discretion of the Administrator. (21 CFR 

1303.11(c) and 21 CFR 1303.13 (c)). I 

find that neither of the foregoing two 

requests presented any evidence that 

would lead me to conclude that a 

hearing is necessary or warranted. 

Therefore, I decline to order a hearing 

on the issues presented by the 

commenters. 

Specific Quota for DEA-Registered 

Manufacturers 

The DEA received comments from 

four DEA-registered manufacturers 

regarding thirty-three different schedule 

I and II controlled substances. These 

commenters stated the proposed 

aggregate production quotas for 3- 

methyl fentanyl, 4–ANPP, acetyl 

fentanyl, acryl fentanyl, betahydroxythiofentanyl, butyrl fentanyl, 

carfentanil, cyclopentyl fentanyl, 

cyclopropyl fentanyl, d-amphetamine 

(for sale), d,l-amphetamine, difenoxylate 

(for sale), fentanyl, fentanyl related 

substances, furanyl fentanyl, gamma 

hydroxybutyric acid, isobytyryl 

fentanyl, levorphanol, methoxyacetyl 

fentanyl, noroxymorphone (for 

conversion), ocfentanil, opium 

(powder), oxycodone (for sale), parachloroisobutyryl fentanyl, parafluorofentanyl, para-fluorobutyryl 

fentanyl, para-methyoxybutyrl fentanyl, 

remifentanil, sufentanil, 

tetrahydrofuranyl fentanyl, thebaine, U– 

47700, and valeryl fentanyl were 

potentially insufficient to provide for 

the estimated medical, scientific, 

research, and industrial needs of the 

United States, export requirements, and 

the establishment and maintenance of 

reserve stocks. 

The DEA has considered the 

comments for specific controlled 

substances and made adjustments as 

needed which are described below in 

the section titled Determination of 2019 

Aggregate Production Quotas and 

Assessment of Annual Needs. The DEA 

did not receive any comments to the 

proposed established 2019 assessment 

of annual needs for ephedrine, 

pseudoephedrine, and 

phenylpropanolamine. 

Out of Scope 

The DEA received seven comments 

which addressed issues that are outside 

the scope of this final order. The 

comments were general in nature and 

raised issues of specific medical 

illnesses, medical treatments, and 

medication costs and, therefore, are 

outside of the scope of this Final Order, 

and do not impact the original analysis 

involved in establishing the 2019 

aggregate production quotas. 

Determination of 2019 Aggregate 

Production Quotas and Assessment of 

Annual Needs 

In determining the 2019 aggregate 

production quotas and assessment of 

annual needs, the DEA has taken into 

consideration the above comments 

along with the factors previously set 

forth in 21 CFR 1303.11 (as described 

above) and 21 CFR 1315.11, in 

accordance with 21 U.S.C. 826(a), and 

other relevant factors, including the 

2018 manufacturing quotas, current 

2018 sales and inventories, anticipated 

2019 export requirements, industrial 

use, additional applications for 2019 

quotas, as well as information on 

research and product development 

requirements. 

Based on all of the above, the 

Administrator is establishing the 2019 

aggregate production quotas. These 

quotas are lower for codeine (for sale), 

codeine (for conversion), hydrocodone 

(for sale), morphine (for sale), and 

oxycodone (for sale); higher for 

cyclopentyl fentanyl, methoxyacetyl 

fentanyl, N-ethlypentylone (ephylone), 

para-methyoxybutyryl fentanyl, and 

para-chloroisobutyryl fentanyl due to 

their temporarily controlled status; 

higher for amphetamine (for conversion) 

based on increased usage forecasted by 

the FDA and its use in the treatment of 

Attention Deficit Hyperactivity 

Disorder; higher for levorphanol based 

on manufacturers’ ongoing product 

development activities necessary for the 

FDA approval process; and higher for 

opium powder and sufentanil based on 

manufacturers’ projected exports. 

Regarding 3-methylfentanyl, 4–ANPP, 

acetyl fentanyl, acryl fentanyl, betahydroxythiofentanyl, butyryl fentanyl, 

carfentanil, cyclopropyl fentanyl, damphetamine (for sale), d,lamphetamine, difenoxylate (for sale), 

fentanyl, fentanyl related substances, 

furanyl fentanyl, gamma hydroxybutyric 

acid, isobutyryl fentanyl, 

noroxymorphone (for conversion), 

ocfentanil, para-fluorofentanyl, parafluorobutyrl fentanyyl, remifentanil, 

tetrahydrofuranyl fentanyl, thebaine, U– 

47700, and valeryl fentanyl, the DEA 


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has determined the proposed aggregate 

production quotas and assessment of 

annual needs are sufficient to provide 

for the 2019 estimated medical, 

scientific, research, industrial needs of 

the United States, export requirements, 

and the establishment and maintenance 

of reserve stocks. This final order 

establishes these aggregate production 

quotas and assessment of annual needs 

at the same amounts as proposed. 

In accordance with 21 U.S.C. 826, 21 

CFR 1303.11, and 21 CFR 1315.11, the 

Administrator hereby establishes the 

2019 aggregate production quotas for the 

following schedule I and II controlled 

substances and the 2019 assessment of 

annual needs for the list I chemicals 

ephedrine, pseudoephedrine, and 

phenylpropanolamine, expressed in 

grams of anhydrous acid or base, as 

follows: 

Basic class 

Established 

2019 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 (AM–694) ................................................................................................................... 30 

1-Benzylpiperazine .......................................................................................................................................................................... 25 

1-Methyl-4-phenyl-4-propionoxypiperidine ....................................................................................................................................... 10 

1-[1-(2-Thienyl)cyclohexyl]piperidine ............................................................................................................................................... 15 

2-(2,5-Dimethoxy-4-ethylphenyl)ethanamine (2C-E) ....................................................................................................................... 30 

2-(2,5-Dimethoxy-4-methylphenyl)ethanamine (2C-D) .................................................................................................................... 30 

2-(2,5-Dimethoxy-4-nitro-phenyl)ethanamine (2C-N) ...................................................................................................................... 30 

2-(2,5-Dimethoxy-4-(n)-propylphenyl)ethanamine (2C-P) ............................................................................................................... 30 

2-(2,5-Dimethoxyphenyl)ethanamine (2C-H) ................................................................................................................................... 30 

2-(4-Bromo-2,5-dimethoxyphenyl)-N-(2-methoxybenzyl) ethanamine (25B-NBOMe; 2C-B-NBOMe; 25B; Cimbi-36) ................... 30 

2-(4-Chloro-2,5-dimethoxyphenyl)ethanamine (2C-C) .................................................................................................................... 30 

2-(4-Chloro-2,5-dimethoxyphenyl)-N-(2-methoxybenzyl)ethanamine (25C-NBOMe; 2C-C-NBOMe; 25C; Cimbi-82) .................... 25 

2-(4-Iodo-2,5-dimethoxyphenyl)ethanamine (2C-I) .......................................................................................................................... 30 

2-(4-Iodo-2,5-dimethoxyphenyl)-N-(2-methoxybenzyl) ethanamine (25I-NBOMe; 2C-I-NBOMe; 25I; Cimbi-5) ............................. 30 

2,5-Dimethoxy-4-ethylamphetamine (DOET) .................................................................................................................................. 25 

2,5-Dimethoxy-4-(n)-propylthiophenethylamine ............................................................................................................................... 25 

2,5-Dimethoxyamphetamine ............................................................................................................................................................ 25 

2-[4-(Ethylthio)-2,5-dimethoxyphenyl]ethanamine (2C-T-2) ............................................................................................................ 30 

2-[4-(Isopropylthio)-2,5-dimethoxyphenyl]ethanamine (2C-T-4) ...................................................................................................... 30 

3,4,5-Trimethoxyamphetamine ........................................................................................................................................................ 30 

3,4-Methylenedioxyamphetamine (MDA) ........................................................................................................................................ 55 

3,4-Methylenedioxymethamphetamine (MDMA) ............................................................................................................................. 50 

3,4-Methylenedioxy-N-ethylamphetamine (MDEA) ......................................................................................................................... 40 

3,4-Methylenedioxy-N-methylcathinone (methylone) ...................................................................................................................... 40 

3,4-Methylenedioxypyrovalerone (MDPV) ....................................................................................................................................... 35 

3-FMC; 3-Fluoro-N-methylcathinone ............................................................................................................................................... 25 

3-Methylfentanyl ............................................................................................................................................................................... 30 

3-Methylthiofentanyl ......................................................................................................................................................................... 30 

4-Bromo-2,5-dimethoxyamphetamine (DOB) .................................................................................................................................. 30 

4-Bromo-2,5-dimethoxyphenethylamine (2-CB) .............................................................................................................................. 25 

1-(4-Cyanobutyl)-N-(2-phenylpropan-2-yl)-1H-indazole-3-carboximide ........................................................................................... 25 

4-Fluoroisobutyryl fentanyl ............................................................................................................................................................... 30 

4-FMC; Flephedrone ........................................................................................................................................................................ 25 

4-MEC; 4-Methyl-N-ethylcathinone .................................................................................................................................................. 25 

4-Methoxyamphetamine .................................................................................................................................................................. 150 

4-Methyl-2,5-dimethoxyamphetamine (DOM) .................................................................................................................................. 25 

4-Methylaminorex ............................................................................................................................................................................ 25 

4-Methyl-N-methylcathinone (mephedrone) .................................................................................................................................... 45 

4-Methyl-a-pyrrolidinopropiophenone (4-MePPP) ........................................................................................................................... 25 

5-(1,1-Dimethylheptyl)-2-[(1R,3S)-3-hydroxycyclohexyl]-phenol ..................................................................................................... 50 

5-(1,1-Dimethyloctyl)-2-[(1R,3S)-3-hydroxycyclohexyl]-phenol (cannabicyclohexanol or CP-47,497 C8-homolog) ....................... 40 

N-(1-Amino-3-methyl-1-oxobutan-2-yl)-1-(5-fluoropentyl)-1H-indazole-3-carboxamide .................................................................. 25 

1-(5-Fluoropentyl)-N-(2-phenylpropan-2-yl)-1H-pyrrolo[2,3-b]pyridine-3-carboxamide ................................................................... 25 

5F-ADB; 5F-MDMB-PINACA (methyl 2-(1-(5-fluoropentyl)-1H-indazole-3-carboxamido)-3,3-dimethylbutanoate) ........................ 30 

5F-AMB (methyl 2-(1-(5-fluoropentyl)-1H-indazole-3-carboxamido)-3-methylbutanoate) ............................................................... 30 

5F-APINACA; 5F-AKB48 (N-(adamantan-1-yl)-1-(5-fluoropentyl)-1H-indazole-3-carboxamide) .................................................... 30 

5-Fluoro-PB-22; 5F-PB-22 ............................................................................................................................................................... 20 

5-Fluoro-UR144, XLR11 ([1-(5-fluoro-pentyl)-1Hindol- ...................................................................................................................

3-yl](2,2,3,3-tetramethylcyclopropyl)methanone .............................................................................................................................. 25 

5-Methoxy-3,4-methylenedioxyamphetamine .................................................................................................................................. 25 

5-Methoxy-N-N-diisopropyltryptamine ............................................................................................................................................. 25 

5-Methoxy-N-N-dimethyltryptamine ................................................................................................................................................. 25 

AB-CHMINACA ................................................................................................................................................................................ 30 

AB-FUBINACA ................................................................................................................................................................................. 50 

AB-PINACA ...................................................................................................................................................................................... 30 

ADB-FUBINACA (N-(1-amino-3,3-dimethyl-1-oxobutan-2-yl)-1-(4-fluorobenzyl)-1H-indazole-3-carboxamide) .............................. 30 

Acetyl Fentanyl ................................................................................................................................................................................ 100 


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Basic class 

Established 

2019 quotas 

(g) 

Acetyl-alpha-methylfentanyl ............................................................................................................................................................. 30 

Acetyldihydrocodeine ....................................................................................................................................................................... 30 

Acetylmethadol ................................................................................................................................................................................ 2 

Acryl Fentanyl .................................................................................................................................................................................. 25 

ADB-PINACA (N-(1-amino-3,3-dimethyl-1-oxobutan-2-yl)-1-pentyl-1H-indazole-3-carboxamide) .................................................. 50 

AH-7921 ........................................................................................................................................................................................... 30 

Allylprodine ...................................................................................................................................................................................... 2 

Alphacetylmethadol .......................................................................................................................................................................... 2 

alpha-Ethyltryptamine ...................................................................................................................................................................... 25 

Alphameprodine ............................................................................................................................................................................... 2 

Alphamethadol ................................................................................................................................................................................. 2 

alpha-Methylfentanyl ........................................................................................................................................................................ 30 

alpha-Methylthiofentanyl .................................................................................................................................................................. 30 

alpha-Methyltryptamine (AMT) ........................................................................................................................................................ 25 

alpha-Pyrrolidinobutiophenone (a-PBP) .......................................................................................................................................... 25 

alpha-Pyrrolidinopentiophenone (a-PVP) ........................................................................................................................................ 25 

Aminorex .......................................................................................................................................................................................... 25 

Anileridine ........................................................................................................................................................................................ 20 

APINACA, AKB48 (N-(1-adamantyl)-1-pentyl-1H-indazole-3-carboxamide) ................................................................................... 25 

Benzylmorphine ............................................................................................................................................................................... 30 

Betacetylmethadol ........................................................................................................................................................................... 2 

beta-Hydroxy-3-methylfentanyl ........................................................................................................................................................ 30 

beta-Hydroxyfentanyl ....................................................................................................................................................................... 30 

beta-Hydroxythiofentanyl ................................................................................................................................................................. 30 

Betameprodine ................................................................................................................................................................................. 2 

Betamethadol ................................................................................................................................................................................... 4 

Betaprodine ...................................................................................................................................................................................... 2 

Bufotenine ........................................................................................................................................................................................ 3 

Butylone ........................................................................................................................................................................................... 25 

Butyryl Fentanyl ............................................................................................................................................................................... 30 

Cathinone ......................................................................................................................................................................................... 24 

Codeine methylbromide ................................................................................................................................................................... 30 

Codeine-N-oxide .............................................................................................................................................................................. 192 

Cyclopentyl Fentanyl ....................................................................................................................................................................... 30 

Cyclopropyl Fentanyl ....................................................................................................................................................................... 20 

Desomorphine .................................................................................................................................................................................. 25 

Diampromide .................................................................................................................................................................................... 20 

Diethylthiambutene .......................................................................................................................................................................... 20 

Diethyltryptamine ............................................................................................................................................................................. 25 

Difenoxin .......................................................................................................................................................................................... 8,225 

Dihydromorphine .............................................................................................................................................................................. 753,500 

Dimethyltryptamine .......................................................................................................................................................................... 50 

Dipipanone ....................................................................................................................................................................................... 5 

Etorphine .......................................................................................................................................................................................... 30 

Fenethylline ...................................................................................................................................................................................... 30 

Fentanyl related substances ............................................................................................................................................................ 25 

Furanyl Fentanyl .............................................................................................................................................................................. 30 

gamma-Hydroxybutyric acid ............................................................................................................................................................ 33,417,000 

Heroin .............................................................................................................................................................................................. 45 

Hydromorphinol ................................................................................................................................................................................ 40 

Hydroxypethidine ............................................................................................................................................................................. 2 

Ibogaine ........................................................................................................................................................................................... 30 

Isobutyryl Fentanyl ........................................................................................................................................................................... 25 

JWH-018 and AM678 (1-Pentyl-3-(1-naphthoyl)indole) .................................................................................................................. 35 

JWH-019 (1-Hexyl-3-(1-naphthoyl)indole) ....................................................................................................................................... 45 

JWH-073 (1-Butyl-3-(1-naphthoyl)indole) ........................................................................................................................................ 45 

JWH-081 (1-Pentyl-3-(1-(4-methoxynaphthoyl))indole) ................................................................................................................... 30 

JWH-122 (1-Pentyl-3-(4-methyl-1-naphthoyl)indole) ....................................................................................................................... 30 

JWH-200 (1-[2-(4-Morpholinyl)ethyl]-3-(1-naphthoyl)indole) ........................................................................................................... 35 

JWH-203 (1-Pentyl-3-(2-chlorophenylacetyl)indole) ........................................................................................................................ 30 

JWH-250 (1-Pentyl-3-(2-methoxyphenylacetyl)indole) .................................................................................................................... 30 

JWH-398 (1-Pentyl-3-(4-chloro-1-naphthoyl)indole) ........................................................................................................................ 30 

Lysergic acid diethylamide (LSD) .................................................................................................................................................... 40 

MAB-CHMINACA; ADB-CHMINACA (N-(1-amino-3,3-dimethyl-1-oxobutan-2-yl)-1-(cyclohexylmethyl)-1H-indazole-3- 

carboxamide) ................................................................................................................................................................................ 30 

MDMB-CHMICA; MMB-CHMINACA(methyl 2-(1-(cyclohexylmethyl)-1H-indole-3-carboxamido)-3,3-dimethylbutanoate) ............. 30 

MDMB-FUBINACA (methyl 2-(1-(4-fluorobenzyl)-1H-indazole-3-carboxamido)-3,3-dimethylbutanoate) ....................................... 30 

Methyl2-(1-(cyclohexylmethyl)-1H-indole-3-carboxamido)-3-methylbutanoate ............................................................................... 25 

Marihuana ........................................................................................................................................................................................ 2,450,000 

Mecloqualone ................................................................................................................................................................................... 30 

Mescaline ......................................................................................................................................................................................... 25 

Methaqualone .................................................................................................................................................................................. 60 


amozie on DSK3GDR082PROD with NOTICES1
Federal Register / Vol. 83, No. 248 / Friday, December 28, 2018 / Notices 67353 

Basic class 

Established 

2019 quotas 

(g) 

Methcathinone ................................................................................................................................................................................. 25 

Methoxyacetyl Fentanyl ................................................................................................................................................................... 30 

Methyldesorphine ............................................................................................................................................................................. 5 

Methyldihydromorphine .................................................................................................................................................................... 2 

Morphine methylbromide ................................................................................................................................................................. 5 

Morphine methylsulfonate ................................................................................................................................................................ 5 

Morphine-N-oxide ............................................................................................................................................................................ 150 

Naphthalen-1-yl 1-(5-fluorpentyl)-1H-indole-3-carboxylate .............................................................................................................. 25 

N,N-Dimethylamphetamine .............................................................................................................................................................. 25 

Naphyrone ....................................................................................................................................................................................... 25 

N-Ethyl-1-phenylcyclohexylamine .................................................................................................................................................... 5 

N-Ethyl-3-piperidyl benzilate ............................................................................................................................................................ 10 

N-Ethylamphetamine ....................................................................................................................................................................... 24 

N-Ethylpentylone (ephylone) ........................................................................................................................................................... 30 

N-Hydroxy-3,4-methylenedioxyamphetamine .................................................................................................................................. 24 

Noracymethadol ............................................................................................................................................................................... 2 

Norlevorphanol ................................................................................................................................................................................. 55 

Normethadone ................................................................................................................................................................................. 2 

Normorphine .................................................................................................................................................................................... 40 

Ocfentanil ......................................................................................................................................................................................... 25 

Ortho-parafluorofentanyl .................................................................................................................................................................. 30 

Para-chlorisobutyrl Fentanyl ............................................................................................................................................................ 30 

Para-flourobutyryl Fentanyl .............................................................................................................................................................. 25 

Para-fluorofentanyl ........................................................................................................................................................................... 25 

Para-methoxybutyrl Fentanyl ........................................................................................................................................................... 30 

Parahexyl ......................................................................................................................................................................................... 5 

PB-22; QUPIC ................................................................................................................................................................................. 20 

Pentedrone ...................................................................................................................................................................................... 25 

Pentylone ......................................................................................................................................................................................... 25 

Phenomorphan ................................................................................................................................................................................ 2 

Pholcodine ....................................................................................................................................................................................... 5 

Psilocybin ......................................................................................................................................................................................... 30 

Psilocyn ............................................................................................................................................................................................ 50 

SR-18 and RCS-8 (1-Cyclohexylethyl-3-(2-methoxyphenylacetyl)indole) ....................................................................................... 45 

SR-19 and RCS-4 (1-Pentyl-3-[(4-methoxy)-benzoyl]indole) .......................................................................................................... 30 

Tetrahydrocannabinols .................................................................................................................................................................... 384,460 

Tetrahydrofuranyl fentanyl ............................................................................................................................................................... 5 

Thiofentanyl ..................................................................................................................................................................................... 25 

THJ-2201 ( [1-(5-fluoropentyl)-1H-indazol-3-yl](naphthalen-1-yl)methanone) ................................................................................ 30 

Tilidine .............................................................................................................................................................................................. 25 

Trimeperidine ................................................................................................................................................................................... 2 

UR-144 (1-pentyl-1H-indol-3-yl)(2,2,3,3-tetramethylcyclopropyl)methanone .................................................................................. 25 

U-47700 ........................................................................................................................................................................................... 30 

Valeryl fentanyl ................................................................................................................................................................................ 25 

Schedule II 

1-Phenylcyclohexylamine ................................................................................................................................................................ 15 

1-Piperidinocyclohexanecarbonitrile ................................................................................................................................................ 25 

4-Anilino-N-phenethyl-4-piperidine (ANPP) ..................................................................................................................................... 1,185,000 

Alfentanil .......................................................................................................................................................................................... 6,200 

Alphaprodine .................................................................................................................................................................................... 2 

Amobarbital ...................................................................................................................................................................................... 20,100 

Amphetamine (for conversion) ........................................................................................................................................................ 12,700,000 

Amphetamine (for sale) ................................................................................................................................................................... 42,400,000 

Carfentanil ........................................................................................................................................................................................ 20 

Cocaine ............................................................................................................................................................................................ 92,120 

Codeine (for conversion) ................................................................................................................................................................. 12,900,000 

Codeine (for sale) ............................................................................................................................................................................ 36,114,260 

Dextropropoxyphene ........................................................................................................................................................................ 35 

Dihydrocodeine ................................................................................................................................................................................ 238,466 

Dihydroetorphine .............................................................................................................................................................................. 2 

Diphenoxylate (for conversion) ........................................................................................................................................................ 14,100 

Diphenoxylate (for sale) ................................................................................................................................................................... 770,800 

Ecgonine .......................................................................................................................................................................................... 88,134 

Ethylmorphine .................................................................................................................................................................................. 30 

Etorphine hydrochloride ................................................................................................................................................................... 32 

Fentanyl ........................................................................................................................................................................................... 1,185,000 

Glutethimide ..................................................................................................................................................................................... 2 

Hydrocodone (for conversion) ......................................................................................................................................................... 5,000 

Hydrocodone (for sale) .................................................................................................................................................................... 43,027,640 

Hydromorphone ............................................................................................................................................................................... 4,071,000 


amozie on DSK3GDR082PROD with NOTICES1
67354 Federal Register / Vol. 83, No. 248 / Friday, December 28, 2018 / Notices 

Basic class 

Established 

2019 quotas 

(g) 

Isomethadone .................................................................................................................................................................................. 30 

Levo-alphacetylmethadol (LAAM) .................................................................................................................................................... 5 

Levomethorphan .............................................................................................................................................................................. 4,000 

Levorphanol ..................................................................................................................................................................................... 38,000 

Lisdexamfetamine ............................................................................................................................................................................ 19,000,000 

Meperidine ....................................................................................................................................................................................... 1,580,000 

Meperidine Intermediate-A .............................................................................................................................................................. 30 

Meperidine Intermediate-B .............................................................................................................................................................. 30 

Meperidine Intermediate-C .............................................................................................................................................................. 30 

Metazocine ....................................................................................................................................................................................... 15 

Methadone (for sale) ....................................................................................................................................................................... 22,278,000 

Methadone Intermediate .................................................................................................................................................................. 24,064,000 

Methamphetamine ........................................................................................................................................................................... 1,446,754 

[846,000 grams of levo-desoxyephedrine for use in a non-controlled, non-prescription product; 564,000 grams for methamphetamine mostly for 

conversion to a schedule III product; and 36,754 grams for methamphetamine (for sale)]. 

Methylphenidate ............................................................................................................................................................................... 64,600,000 

Morphine (for conversion) ................................................................................................................................................................ 4,089,000 

Morphine (for sale) .......................................................................................................................................................................... 29,353,676 

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) ............................................................................................................................................................ 2,081,000 

Oxycodone (for sale) ....................................................................................................................................................................... 79,596,606 

Oxymorphone (for conversion) ........................................................................................................................................................ 24,525,540 

Oxymorphone (for sale) ................................................................................................................................................................... 2,880,000 

Pentobarbital .................................................................................................................................................................................... 25,850,000 

Phenazocine .................................................................................................................................................................................... 5 

Phencyclidine ................................................................................................................................................................................... 35 

Phenmetrazine ................................................................................................................................................................................. 25 

Phenylacetone ................................................................................................................................................................................. 40 

Racemethorphan ............................................................................................................................................................................. 5 

Racemorphan .................................................................................................................................................................................. 5 

Remifentanil ..................................................................................................................................................................................... 3,000 

Secobarbital ..................................................................................................................................................................................... 172,100 

Sufentanil ......................................................................................................................................................................................... 4,000 

Tapentadol ....................................................................................................................................................................................... 18,388,280 

Thebaine .......................................................................................................................................................................................... 84,600,000 

List I Chemicals 

Ephedrine (for conversion) .............................................................................................................................................................. 25 

Ephedrine (for sale) ......................................................................................................................................................................... 4,136,000 

Phenylpropanolamine (for conversion) ............................................................................................................................................ 14,100,000 

Phenylpropanolamine (for sale) ....................................................................................................................................................... 7,990,000 

Pseudoephedrine (for conversion) .................................................................................................................................................. 1,000 

Pseudoephedrine (for sale) ............................................................................................................................................................. 174,246,000 

The Administrator also establishes 

aggregate production quotas for all other 

schedule I and II controlled substances 

included in 21 CFR 1308.11 and 

1308.12 at zero. In accordance with 21 

CFR 1303.13 and 21 CFR 1315.13, upon 

consideration of the relevant factors, the 

Administrator may adjust the 2019 

aggregate production quotas and 

assessment of annual needs as needed. 

Dated: December 20, 2018. 

Uttam Dhillon, 

Acting Administrator. 

[FR Doc. 2018–28108 Filed 12–27–18; 8:45 am] 

BILLING CODE 4410–09–P 

DEPARTMENT OF LABOR 

Employment and Training 

Administration 

Agency Information Collection 

Activities; Comment Request; 

Transmittal for Unemployment 

Insurance Materials 

ACTION: Notice. 

SUMMARY: The Department of Labor’s 

(DOL’s), Employment and Training 

Administration (ETA) is soliciting 

comments concerning a proposed 

extension for the authority to conduct 

the information collection request (ICR) 

titled, ‘‘Transmittal for Unemployment 

Insurance Materials.’’ This comment 

request is part of continuing 

Departmental efforts to reduce 

paperwork and respondent burden in 

accordance with the Paperwork 

Reduction Act of 1995 (PRA). 

DATES: Consideration will be given to all 

written comments received by February 

26, 2019. 

ADDRESSES: A copy of this ICR with 

applicable supporting documentation, 

including a description of the likely 

respondents, proposed frequency of 

response, and estimated total burden, 


amozie on DSK3GDR082PROD with NOTICES1