76604 Federal Register / Vol. 85, No. 230 / Monday, November 30, 2020 / Notices 

notifications disclosing all changes in 

membership. 

On September 10, 2018, CONFERS 

filed its original notification pursuant to 

Section 6(a) of the Act. The Department 

of Justice published a notice in the 

Federal Register pursuant to Section 

6(b) of the Act on October 19, 2018 (83 

FR 53106). 

The last notification was filed with 

the Department on May 1, 2020. A 

notice was published in the Federal 

Register pursuant to Section 6(b) of the 

Act on May 28, 2020 (85 FR 32049). 

Suzanne Morris, 

Chief, Premerger and Division Statistics, 

Antitrust Division. 

[FR Doc. 2020–26358 Filed 11–27–20; 8:45 am] 

BILLING CODE 4410–11–P 

DEPARTMENT OF JUSTICE 

Antitrust Division 

Notice Pursuant to the National 

Cooperative Research and Production 

Act of 1993—Dynamic Spectrum 

Alliance, Inc. 

Notice is hereby given that, on 

November 23, 2020, pursuant to Section 

6(a) of the National Cooperative 

Research and Production Act of 1993, 

15 U.S.C. 4301 et seq. (‘‘the Act’’), 

Dynamic Spectrum Alliance, Inc. 

(‘‘DSA’’) has filed written notifications 

simultaneously with the Attorney 

General and the Federal Trade 

Commission disclosing changes in its 

membership. The notifications were 

filed for the purpose of extending the 

Act’s provisions limiting the recovery of 

antitrust plaintiffs to actual damages 

under specified circumstances. 

Specifically, The University of York, 

Heslington, UNITED KINGDOM; 

Amazon, Sunnyvale, CA; and Google, 

Mountain View, CA have been added as 

parties to this venture. 

No other changes have been made in 

either the membership or planned 

activity of the group research project. 

Membership in this group research 

project remains open, and DSA intends 

to file additional written notifications 

disclosing all changes in membership. 

On September 1, 2020, DSA filed its 

original notification pursuant to Section 

6(a) of the Act. The Department of 

Justice published a notice in the Federal 

Register pursuant to Section 6(b) of the 

Act on September 18, 2020 (85 FR 

58390). 

Suzanne Morris, 

Chief, Premerger and Division Statistics, 

Antitrust Division. 

[FR Doc. 2020–26362 Filed 11–27–20; 8:45 am] 

BILLING CODE P 

DEPARTMENT OF JUSTICE 

Antitrust Division 

Notice Pursuant to the National 

Cooperative Research and Production 

Act of 1993—Cooperative Research 

Group on AC2AT–II 

Notice is hereby given that, on 

November 19, 2020, pursuant to Section 

6(a) of the National Cooperative 

Research and Production Act of 1993, 

15 U.S.C. 4301 et seq. (‘‘the Act’’), 

Southwest Research Institute— 

Cooperative Research Group on 

Advanced Combustion Catalyst and 

Aftertreatment Technologies—II 

(‘‘AC2AT–II’’) has filed written 

notifications simultaneously with the 

Attorney General and the Federal Trade 

Commission disclosing changes in its 

membership. The notifications were 

filed for the purpose of extending the 

Act’s provisions limiting the recovery of 

antitrust plaintiffs to actual damages 

under specified circumstances. 

Specifically, Denso Corporation 

‘‘Client’’, Aichi-ken, JAPAN, has 

withdrawn as a party to this venture. No 

other changes have been made in either 

the membership or planned activity of 

the group research project. Membership 

in this group research project remains 

open, and AC2AT–II intends to file 

additional written notifications 

disclosing all changes in membership. 

On February 6, 2019, AC2AT–II filed 

its original notification pursuant to 

Section 6(a) of the Act. The Department 

of Justice published a notice in the 

Federal Register pursuant to Section 

6(b) of the Act on February 28, 2019 (84 

FR 6821). 

Suzanne Morris, 

Chief, Premerger and Division Statistics, 

Antitrust Division. 

[FR Doc. 2020–26361 Filed 11–27–20; 8:45 am] 

BILLING CODE 4410–11–P 

DEPARTMENT OF JUSTICE 

Drug Enforcement Administration 

[Docket No. DEA–688E] 

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 2021 

AGENCY: Drug Enforcement 

Administration, Department of Justice. 

ACTION: Final order. 

SUMMARY: This final order establishes 

the initial 2021 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: Applicable Date: Applicable 

November 30, 2020. 

FOR FURTHER INFORMATION CONTACT: 

Scott A. Brinks, Diversion Control 

Division, Drug Enforcement 

Administration, 8701 Morrissette Drive, 

Springfield, VA 22152, Telephone: (571) 

362–3261. 

SUPPLEMENTARY INFORMATION: 

I. 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 schedule I and II and 

assessment of annual needs for the list 

I chemicals ephedrine, 

pseudoephedrine, and 

phenylpropanolamine. The Attorney 

General has delegated this function to 

the Administrator of the Drug 

Enforcement Administration (DEA) 

pursuant to 28 CFR 0.100. 

II. Background 

The 2021 aggregate production quotas 

(APQ) and assessment of annual needs 

(AAN) 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 

2021 to provide for the estimated 

medical, scientific, research, 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 


TKELLEY on DSKBCP9HB2PROD with NOTICES
Federal Register / Vol. 85, No. 230 / Monday, November 30, 2020 / Notices 76605 

1Public Law 115–271. 

substances for use in industrial 

processes. 

On September 1, 2020, 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 2021’’ 

(hereinafter ‘‘Proposed 2021 APQ’’) was 

published in the Federal Register. 85 FR 

54407. This notice proposed the 2021 

APQ for each basic class of controlled 

substance listed in schedules I and II 

and the 2021 AAN for the list I 

chemicals ephedrine, pseudoephedrine, 

and phenylpropanolamine. All 

interested persons were invited to 

comment on or object to the proposed 

APQ and the proposed AAN on or 

before October 1, 2020. 

III. Comments Received 

Within the public comment period, 

DEA received 294 comments from DEA 

registrants, hospital associations, 

professional associations, doctors, 

nurses, health system organizations, 

State Attorneys General, and others. The 

comments included concerns over drug 

shortages due to further quota 

reductions from doctors and nurses, 

patients, and various health groups and 

hospital affiliations; requests for less 

interference in the doctor-patient 

relationship; concerns about the quota 

process with a request for public 

hearing; and comments not pertaining to 

DEA regulated activities. 

The majority of the commenters 

expressed concerns regarding the 

potential adverse impact of the decrease 

to the APQ of controlled substances on 

the availability of pain-relieving 

prescription drugs for people with 

chronic pain. DEA received comments 

from four DEA-registered manufacturers 

regarding ten different schedule I and II 

controlled substances. Commenters 

stated the proposed APQ for ANPP, damphetamine (for conversion), fentanyl, 

hydrocodone (for sale), hydromorphone, 

lisdexamfetamine, morphine (for 

conversion), noroxymorphone (for 

conversion), oxycodone (for sale), and 

sufentanil be sufficient for 

manufacturers to meet medical and 

scientific needs. DEA has considered 

the comments for specific controlled 

substances in establishing the 2021 

APQ. 

DEA received no comments regarding 

the proposed established 2021 AAN for 

ephedrine, pseudoephedrine, and 

phenylpropanolamine. 

A. Shortages 

Issue: Some commenters expressed 

concerns about the decrease in certain 

APQ. These commenters alleged that 

decreases to the APQ have resulted in 

a shortage of injectable opioid 

medications and interfere with the 

treatment of patients. Some of these 

commenters also suggested that DEA 

separate quotas for solid oral controlled 

substances and injectable controlled 

substances, and urged DEA to utilize its 

discretionary authority under the 

Substance Use-Disorder Prevention that 

Promotes Opioid Recovery and 

Treatment Act (SUPPORT Act),1 to 

establish APQ in terms of 

pharmaceutical dosage form for all 

schedule II controlled substances. 

DEA Response: DEA is committed to 

ensuring an adequate and uninterrupted 

supply of controlled substances in order 

to meet the legitimate medical, 

scientific, and export needs of the 

United States. DEA sets APQ in a 

manner to provide for all dispensings 

authorized for legitimate medical 

purposes, and in turn, the APQ take into 

consideration both injectable opioids 

and solid oral opioids to meet the 

estimated medical needs of the United 

States. The SUPPORT Act allows, but 

does not require, 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 believes that incorporating all 

dosage forms into the APQ, rather than 

allocating APQ by dosage form, allows 

the agency flexibility to adjust the 

individual quotas granted to 

manufacturers to alleviate any potential 

shortages and react to unforeseen 

emergencies. DEA believes the most 

accurate use of this authority would be 

in determining individual procurement 

quotas, if warranted under the 

circumstances. For example, if there 

was a shortage of any dosage form, the 

APQ would not need to be raised for 

manufacturers to produce that specific 

dosage form. Conversely, if multiple 

APQ for dosage forms were permitted, it 

is more likely that the APQ for that 

dosage form would need to be raised to 

respond to such a shortage before 

production could commence, thereby 

delaying the response time to the 

shortage. 

Although DEA sets the APQ, it is 

possible that the business practices of 

manufacturers may lead to a shortage of 

controlled substances at the patient 

level, despite the adequacy of the APQ 

set by DEA. DEA can grant an 

individual quota to a manufacturer, and 

pursuant to the SUPPORT Act, also has 

the authority to grant individual 

manufacturing and/or procurement 

quotas for specific dosage forms; 

however, DEA cannot demand that the 

manufacturer utilize the quota 

immediately, nor does it have the 

authority to demand immediate 

production of dosage forms. 

DEA and the Food and Drug 

Administration (FDA) are required to 

coordinate efforts to prevent or alleviate 

drug shortages pursuant to 21 U.S.C. 

826(h) and maintain a collaborative 

working relationship. In addition, DEA 

and FDA have worked collaboratively. 

For example, in 2016 the domestic 

shortage of injectable controlled 

substances was alleviated by the 

importation of certain injectable 

controlled substances coordinated by 

the collaborated effort of FDA and DEA. 

The alleviation of this drug shortage did 

not require an adjustment to the APQ. 

Again in 2020, when hospitals informed 

DEA that there was a domestic shortage 

of injectable controlled substances due 

to the Coronavirus Disease of 2019 

(COVID–19) health emergency, DEA 

collaborated with FDA to increase the 

appropriate APQ and individual quotas 

to allow for increased manufacturing of 

the specific drug products. 

B. Pain Management Association Letters 

Issue: DEA received comments that 

expressed concern that DEA’s proposed 

reduction of opioids would adversely 

impact the availability of pain-relieving 

prescription drugs for people with 

chronic pain. The general concern is 

that lowering the APQ, which in turn 

decreases the amount available for 

physicians to write prescriptions, 

increases the probability that a 

physician cannot or will not prescribe 

such pain-relieving drugs. 

DEA Response: DEA sets APQ in a 

manner to ensure that all prescriptions 

authorized for legitimate medical 

purposes can be filled. DEA does not set 

guidelines regarding patterns of 

prescribing medications, nor does DEA 

determine what dosage(s) are deemed 

‘‘medically necessary.’’ Prescribers 

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 

knowingly filling such a prescription 

would be in violation of the CSA. 

C. Relevant Information Obtained From 

Health and Human Services (HHS) 

Agencies 

Some commenters, including the 

State Attorneys General for West 

Virginia, Kentucky, Arkansas, and 


TKELLEY on DSKBCP9HB2PROD with NOTICES
76606 Federal Register / Vol. 85, No. 230 / Monday, November 30, 2020 / Notices 

South Dakota, were concerned with 

DEA’s use and/or analysis of relevant 

information from HHS, including: (1) 

Centers for Medicare and Medicaid 

Services (CMS) data on overprescribing; 

(2) FDA data; and (3) Centers for Disease 

Control and Prevention (CDC) data on 

overdose deaths. 

CMS Data on Over-Prescribing 

Issue: Some commenters expressed 

concern with DEA’s use and 

interpretation of CMS data; particularly, 

in how such raw data would be used in 

the future to draw conclusions on the 

issue of overprescribing. Pain 

management associations questioned 

how DEA would distinguish between 

appropriate and inappropriate 

prescribing, and urged DEA to use 

‘‘nuanced and evidence-based means to 

draw distinctions between appropriate 

and inappropriate use.’’ These 

associations also cautioned against 

misapplying dosage thresholds from 

CDC prescription guidance for schedule 

II substances to determine 

overprescribing rates. 

DEA Response: As previously stated, 

DEA sets APQ in a manner to ensure 

that all prescriptions authorized for 

legitimate medical purposes can be 

filled. DEA does not set guidelines 

regarding patterns of prescribing 

medications, nor does DEA determine 

what dosage(s) can be deemed 

‘‘medically necessary.’’ Prescribers 

authorized to dispense controlled 

substances are responsible for adhering 

to the laws and regulations set forth 

under the CSA, which require doctors to 

only write prescriptions for legitimate 

medical needs. Any practitioner issuing 

an invalid prescription for controlled 

substances and any pharmacy 

knowingly filling such a prescription 

would be in violation of the CSA. 

As DEA discussed in the prior 

Proposed 2021 APQ, DEA contacted 

HHS and CMS, a component of HHS, to 

explore the possibility of using the 

agencies’ data to estimate over 

prescribing. CMS informed DEA that the 

agency had reviewed its internal 

databases, and did not have the ability 

to systematically distinguish between 

appropriate and inappropriate 

prescriptions without investigating each 

prescription. 

Issue: West Virginia, and joining state 

commenters, raised concerns that 

overprescribing, i.e., opioids prescribed 

beyond actual medical needs, was not 

accounted for as part of diversion. The 

States noted that ‘‘DEA has not 

accounted for illegitimate—but legal— 

demand for opioids through 

overprescribing.’’ 

DEA Response: DEA sets APQ in a 

manner to ensure that all prescriptions 

authorized for legitimate medical 

purposes can be filled. Again, DEA does 

not set guidelines regarding patterns of 

prescribing medications, nor does DEA 

set guidelines as to what dosage(s) can 

be deemed ‘‘medically necessary.’’ 

Upon review of the studies cited in 

West Virginia’s comment letter, DEA 

has determined that they are insufficient 

to support a reduction in the APQ. The 

studies cited found that for a variety of 

medical procedures, physicians 

prescribe more controlled substances for 

post-operative pain than patients utilize. 

While the referenced studies are 

concerning, DEA has concluded they are 

insufficient to support a determination 

on the level of overprescribing that 

occurs across the range of the medical 

procedures performed each year 

nationwide. 

Prescribers authorized to dispense 

controlled substances are responsible 

for adhering to the laws and regulations 

set forth under the CSA, which require 

doctors to only write prescriptions for 

legitimate medical needs. Any 

practitioner issuing an invalid 

prescription for controlled substances 

and any pharmacy knowingly filling 

such a prescription would be in 

violation of the CSA. As DEA explores 

the possibility of using state 

Prescription Drug Monitoring Program 

(PDMP) data to estimate diversion, it 

may be possible to reliably discern overprescribing on a national level and use 

this information to help determine the 

APQ. However, DEA does not currently 

have access to this data. Additionally, 

DEA previously attempted to use CMS 

data, but CMS did not have the ability 

to systematically distinguish between 

appropriate and inappropriate 

prescriptions without investigating each 

prescription. 

FDA Data 

Issue: West Virginia, and joining state 

commenters, took exception to DEA’s 

response to FDA’s projected levels of 

medical need for selected controlled 

substances, claiming that DEA outright 

rejected FDA recommendations. 

DEA Response: DEA did not reject 

critical FDA ‘‘recommendations.’’ The 

term ‘‘recommendation’’ as used by the 

states appears to have been incorrectly 

interpreted; FDA only provided to DEA 

data that estimated legitimate domestic 

medical need. The data allowed DEA to 

estimate a collective decline in opioids 

to meet legitimate domestic medical 

need. Scientific, research, industrial 

needs, lawful export requirements, and 

the establishment and maintenance of 

reserve stocks are derived from 

information provided from quota 

applicants and research protocols 

submitted directly to DEA. On April 10, 

2020, DEA published adjustments to the 

2020 APQ for specific controlled 

substances identified by HHS COVID– 

19 treatment protocols, in order to allow 

manufacturers to meet the new and 

unforeseen medical need. 85 FR 20302. 

As explained in that notice, FDA’s data 

was based on an analysis performed 

prior to the declaration of a national 

public health emergency due to COVID– 

19 by the HHS Secretary on January 31, 

2020. DEA and HHS subsequently 

worked in concert to determine changes 

in legitimate medical need based on the 

unforeseen emergency posed by 

COVID–19, particularly the need of 

certain controlled substances required 

to treat patients on ventilators. 

As stated in the Proposed 2021 APQ, 

DEA considered both the potential for 

diversion as well as the anticipated 

increase in demand for opioids used to 

treat patients with COVID–19, as 

previously identified by HHS, in 

proposing the 2021 APQ for those 

specific controlled substances. 

Issue: Another commenter pointed 

out that while FDA’s recommendation 

may have been made prior to the 

declaration of the COVID–19 

emergency, DEA still did not provide 

any information about how it accounted 

for the impact of COVID–19 when 

arriving at its 2021 proposed APQ. 

DEA Response: In the April 10, 2020 

notice, DEA stated that DEA and HHS 

worked in concert to determine changes 

in legitimate medical need based on the 

unforeseen emergency posed by 

COVID–19, particularly the need of 

certain controlled substances required 

to treat patients on ventilators. DEA 

extended the projections provided by 

HHS to insure the relevant APQ were 

established to account for the predicted 

‘‘second wave’’ of COVID–19 patients 

for the upcoming months. 

CDC Data and Overdose Deaths 

Issue: One commenter took issue with 

DEA’s analysis of CDC data and DEA 

not differentiating between types of 

fentanyl overdoses, i.e., overdoses that 

are the result of lawfully manufactured 

fentanyl versus illicit fentanyl. 

DEA Response: CDC provided DEA 

with data from their National Vital 

Statistics System-Mortality files. DEA 

could not determine from CDC’s data if 

the patient overdosed on an illicit 

opioid or a FDA-approved opioid 

product. Nor could DEA determine if 

the overdose was a result of accidental 

or intentional ingestion. As such, DEA 

is unable to determine the number of 


TKELLEY on DSKBCP9HB2PROD with NOTICES
Federal Register / Vol. 85, No. 230 / Monday, November 30, 2020 / Notices 76607 

overdose deaths resulting from fentanyl 

diverted from legitimate sources. 

Whereas DEA is required to consider 

rates of overdose deaths pursuant to 

changes made by the SUPPORT Act, 

DEA concluded that the provided data 

on overdose deaths for 2015 through 

2017 could not be reliably utilized to 

estimate the amount of diversion for the 

five covered controlled substances for 

the 2021 APQ. 

D. Relevant Information Obtained From 

the States 

Issue: Some commenters raised 

concerns that DEA did not adequately 

utilize data from the States. West 

Virginia, and joining state commenters, 

encouraged DEA to expand its 

methodology to enable better use of 

state data that does currently exist, 

despite not having a fulsome set of state 

data. 

DEA Response: DEA solicited relevant 

information from the States and federal 

partners to be considered when setting 

the APQ pursuant to 21 CFR 1303.11. 

As DEA stated in the Proposed 2021 

APQ, only 20 of the 56 State and 

Territory Attorneys General 

acknowledged receipt of DEA’s letters 

requesting information on diversion, 

and of those 20, only nine states sent 

some form of Prescription Drug 

Monitoring Program (PDMP) data to 

DEA. The limited PDMP data that DEA 

received varied in form and content, 

and was ultimately determined to be 

insufficient to develop national 

estimates of diversion for each of the 

five covered controlled substances. 

DEA is currently working with states 

and other federal agencies to obtain 

reliable data that will allow DEA to 

effectively estimate diversion. For 

example, DEA is seeking data from state 

PDMPs which can be evaluated to 

identify common diversion schemes 

such as ‘‘doctor shopping,’’ a scheme in 

which a patient obtains controlled 

substances from multiple treatment 

providers without the providers 

knowing of the other prescriptions. 

Information from PDMPs could assist in 

identifying additional ‘‘red flags’’ that 

may be evidence of diversion and 

misuse of covered controlled 

substances, such as: Over-prescribing; 

patients traveling long distances or 

across state lines to have prescriptions 

filled; early refills; and dangerous drug 

combinations. 

E. The SUPPORT Act Mandates 

Disparate Account of Diversion 

Issue: West Virginia, and joining state 

commenters, raised concern over the 

disparate treatment of the five 

SUPPORT Act covered controlled 

substances and other regulated 

controlled substances in considering 

diversion. 

DEA Response: Pursuant to 21 CFR 

1303.11(b)(5), DEA considered the 

extent of diversion of the basic class as 

a factor in setting the APQ for each 

respective basic class, as well as the 

extent of diversion for all other schedule 

I and II controlled substances in 

proposing the estimated APQ. The 

regulation does not, however, mandate 

that DEA publish the diversion 

estimates for all controlled substances. 

As the state attorneys general comment 

notes, the SUPPORT Act specifically 

requires that DEA provide the diversion 

estimate only for the following five 

covered controlled substances: 

Fentanyl, hydrocodone, 

hydromorphone, oxycodone, and 

oxymorphone. In compliance with the 

SUPPORT Act, DEA published the 

estimated diversion for the five covered 

controlled substances. 

F. Methodology for Determining the 

APQ and AAN Values 

Issue: Some commenters wanted a 

more explicit explanation of DEA’s 

methodology in determining the APQ 

and AAN values. West Virginia, and 

joining state commenters, for instance, 

called for DEA to adopt a ‘‘specific, 

clear, and reproducible methodology 

developed and explained in advance’’ to 

address the ‘‘medically and 

scientifically necessary amount of 

controlled substances.’’ Another 

commenter noted that DEA described 

one such methodology in the 2010 and 

2011 AAN, but claimed that a more 

‘‘explicit discussion of how that 

methodology was applied would be 

beneficial.’’ The same commenter also 

asked that DEA ‘‘publicly provide and 

explicitly discuss the data it consulted 

to validate the need’’ for APQ 

reductions. 

DEA Response: As stated in the 

September 1, 2020, notice, DEA applies 

the factors listed in 21 CFR 1303.11 in 

determining the APQ and 21 CFR 

1315.11 in determining the AAN. FDA 

is required to provide an estimate of the 

quantity of controlled substances 

together with reserves of such drugs that 

are necessary to supply the normal and 

emergency medicinal and scientific 

requirements of the United States to 

DEA. 42 U.S.C. 242(a). Under this 

statute, HHS has delegated that 

responsibility to FDA, which provided 

the relevant information to DEA. DEA 

considered this information, including 

the observed and estimated domestic 

usage of marketed schedule II controlled 

substances, new drug applications and 

abbreviated drug application approvals, 

and clinical trials for schedule I and II 

controlled substances. The 

determination of scientifically necessary 

amounts of controlled substances occurs 

through the submission of business 

confidential and proprietary 

information from manufacturers. DEA 

also considered the impact of products 

entering and exiting the market, 

expected product development, 

expected exports, and inventory data. 

Since 2014, FDA has observed a 

decline in the number of prescriptions 

written for schedule II opioids. DEA 

continues to set aggregate production 

quotas to meet the medical needs of the 

United States while combating the 

opioid crisis. These decreases take into 

account the combined efforts of DEA, 

FDA, and CDC enforcing regulations 

and issuing guidance documents, as 

well as many states enacting 

prescription monitoring database 

programs to stem the opioid epidemic. 

G. Further Collaboration of Agencies 

and Stakeholders; Request for a Public 

Hearing 

Issue: Some commenters suggested 

that DEA further or better collaborate 

with the states, other federal agencies, 

and other industry stakeholders. One 

commenter urged DEA to ‘‘collaborate 

with a broad range of stakeholders’’ to 

‘‘address the opioid crisis while 

ensuring an adequate supply of opioids 

for clinically appropriate care.’’ The 

commenter further suggested that DEA 

should engage such stakeholders in 

roundtable discussions, listening 

sessions, or public hearings. West 

Virginia, and joining state commenters, 

urged DEA to work with states and other 

partners to develop methods to measure 

overprescribing and related forms of 

diversion. Another commenter asked 

that DEA work with ‘‘HHS, Department 

of Defense, and others tasked with 

national security and emergency 

preparedness’’ to ‘‘address any emergent 

supply needs or preemptive supply 

preparation’’ such as those arising from 

the pandemic. 

DEA Response: DEA has and will 

continue to collaborate with federal 

agencies, industry, and medical 

associations to combat the opioid crisis, 

prevent diversion, and set appropriate 

manufacturing quantities of controlled 

substances and chemicals to meet 

legitimate need and preparedness for 

unforeseen circumstances within the 

United States. Additionally, the Federal 

Register comment period provides an 

opportunity for all stakeholders to make 

their issues known to DEA. 

Unfortunately, many of those issues 

revolve around prescribing practices for 


TKELLEY on DSKBCP9HB2PROD with NOTICES
76608 Federal Register / Vol. 85, No. 230 / Monday, November 30, 2020 / Notices 

specific medical conditions. As stated 

previously, DEA does not set guidelines 

regarding patterns of prescribing 

medications nor does DEA determine 

what dosages can be deemed ‘‘medically 

necessary.’’ 

Issue: One commenter stated that the 

DEA should have a hearing to gather 

stakeholder feedback on how DEA can 

help address the opioid epidemic while 

ensuring an adequate supply of opioids 

for clinically appropriate care and 

enable stakeholders to express their 

views about the proposed reductions. 

DEA Response: Under DEA’s 

regulations, the decision of whether to 

grant this type of a hearing on the issues 

raised by the commenter lies solely 

within the discretion of the 

Administrator. 21 CFR 1303.11(c) and 

21 CFR 1303.13(c). The Administrator 

has considered the commenter’s request 

and determined that a hearing is not 

necessary. 

H. Comments From DEA-Registered 

Manufacturers 

DEA received comments from four 

DEA-registered manufacturers regarding 

ten different schedule I and II controlled 

substances, requesting that the proposed 

APQ for ANPP, d-amphetamine (for 

conversion), fentanyl, hydrocodone (for 

sale), hydromorphone, 

lisdexamfetamine, morphine (for 

conversion), noroxymorphone (for 

conversion), oxycodone (for sale), and 

sufentanil be established to sufficient 

levels to allow for manufacturers to 

meet medical and scientific needs. 

DEA considered the comments for 

specific controlled substances and made 

adjustments as needed which are 

described below in the section titled 

Determination of 2021 Aggregate 

Production Quotas and Assessment of 

Annual Needs. 

I. Out of Scope Comments 

DEA received several 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, as well as issues 

related to a separate Federal Register 

notice, and, therefore, were outside of 

the scope of this Final Order, and do not 

impact the original analysis involved in 

establishing the 2021 APQ. 

IV. Determination of 2021 Aggregate 

Production Quotas and Assessment of 

Annual Needs 

In determining the final 2021 

aggregate production quotas and 

assessment of annual needs, DEA has 

considered the above comments along 

with the factors set forth in 21 CFR 

1303.11 and 21 CFR 1315.11, in 

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

other relevant factors, including the 

2020 manufacturing quotas, current 

2020 sales and inventories, anticipated 

2021 export requirements, industrial 

use, additional applications for 2021 

quotas, as well as information on 

research and product development 

requirements. 

DEA also considered the HHS 

Secretary’s renewal of the public health 

emergency due to COVID–19 and 

worked with both FDA and the 

Assistant Secretary for Preparedness 

and Response (ASPR), including their 

revised estimated medical and Strategic 

National Stockpile requirements for 

fentanyl, hydromorphone, and 

morphine in establishing the 2021 APQ. 

Based on all of the above, the 

Administrator is adjusting the 2021 

APQ for 4-anilino-N-phenethyl-4- 

piperadine (ANPP), 5-methoxy-n-ndimethyltryptamine, Crotonyl fentanyl, 

D-methamphetamine (for sale), 

Fentanyl, Ethylone, Etonitazene, 

Gamma hydroxybutyric acid, 

Lisdexamfetamine, and Norlevorphanol. 

Regarding D-amphetamine (for 

conversion), hydrocodone (for sale), 

hydromorphone, morphine (for 

conversion), noroxymorphone (for 

conversion), oxycodone (for sale), and 

sufentanil, DEA has determined the 

proposed APQ are sufficient to provide 

for the 2021 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 APQ as well as the 

AAN at the same amounts as proposed. 

Estimates of Diversion Pursuant to the 

SUPPORT Act 

The SUPPORT Act (21 U.S.C. 

826(i)(1)(a)) requires that ’’in 

establishing any quota under this 

section . . . , for [the covered 

controlled substances], the Attorney 

General shall estimate the amount of 

diversion of the [covered controlled 

substances] that occurs in the United 

States.’’ To estimate diversion as is 

required by the SUPPORT Act, DEA 

aggregated the active pharmaceutical 

ingredient (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 2019 

[kg] 

Fentanyl ................................ 0.090 

Hydrocodone ........................ 30.294 

Hydromorphone .................... 1.424 

Oxycodone ............................ 60.959 

Oxymorphone ....................... 1.311 

In accordance with the SUPPORT Act, 

after estimating the amount of diversion 

for the foregoing five controlled 

substances, DEA made adjustments to 

the individual aggregate production 

quotas for each covered controlled 

substance by the corresponding 

quantities listed in the table. In 

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

1303.11, and 21 CFR 1315.11, the 

Administrator hereby establishes the 

2021 APQ for the following schedule I 

and II controlled substances and the 

2021 AAN for the list I chemicals 

ephedrine, pseudoephedrine, and 

phenylpropanolamine, expressed in 

grams of anhydrous acid or base, as 

follows: 

Basic class Final 2021 quotas 

(g) 

Schedule I 

1-[1-(2-Thienyl)cyclohexyl]pyrrolidine ............................................................................................................................................ 20 

1-(1-Phenylcyclohexyl)pyrrolidine .................................................................................................................................................. 15 

1-(2-Phenylethyl)-4-phenyl-4-acetoxypiperidine ............................................................................................................................ 10 

1-(5-Fluoropentyl)-3-(1-naphthoyl)indole (AM2201) ...................................................................................................................... 30 

1-(5-Fluoropentyl)-3-(2-iodobenzoyl)indole (AM694) ..................................................................................................................... 30 

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

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


TKELLEY on DSKBCP9HB2PROD with NOTICES
Federal Register / Vol. 85, No. 230 / Monday, November 30, 2020 / Notices 76609 

Basic class Final 2021 quotas 

(g) 

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-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 (DMA) .............................................................................................................................................. 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-Fluoro-N-methylcathinone (3–FMC) ........................................................................................................................................... 25 

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

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

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

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

4-Chloro-alpha-pyrrolidinovalerophenone (4-chloro-alpha-PVP) ................................................................................................... 25 

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

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

4-Fluoro-N-methylcathinone (4–FMC; Flephedrone) ..................................................................................................................... 25 

4-Methyl-N-ethylcathinone (4–MEC) ............................................................................................................................................. 25 

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

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

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

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

4-Methyl-alpha-ethylaminopentiophenone (4–MEAP) ................................................................................................................... 25 

4-Methyl-alpha-pyrrolidinohexiophenone (MPHP) ......................................................................................................................... 25 

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

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

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

5F–CUMYL–PINACA ..................................................................................................................................................................... 25 

5F–EDMB–PINACA ....................................................................................................................................................................... 25 

5F–MDMB–PICA ........................................................................................................................................................................... 25 

5F–AB–PINACA; N-(1-amino-3-methyl-1-oxobutan-2-yl)-1-(5-fluoropentyl)-1H-indazole-3-carboxamide .................................... 25 

5F–CUMYL–P7AICA; (1-(5-fluoropentyl)-N-(2-phenylpropan-2-yl)-1H-pyrrolo[2,3-b]pyridine-3-carboximide) ............................. 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)-1H-indol-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 ............................................................................................................................................... 35 

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 

Acetorphine .................................................................................................................................................................................... 25 

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

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

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

Acetylmethadol .............................................................................................................................................................................. 25 

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

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

AH–7921 ........................................................................................................................................................................................ 30 

All other tetrahydrocannabinols ..................................................................................................................................................... 1,000 

Allylprodine .................................................................................................................................................................................... 25 

Alphacetylmethadol ........................................................................................................................................................................ 25 

Alpha-Ethyltryptamine .................................................................................................................................................................... 25 

Alphameprodine ............................................................................................................................................................................. 25 

Alphamethadol ............................................................................................................................................................................... 25 

Alphaprodine .................................................................................................................................................................................. 25 


TKELLEY on DSKBCP9HB2PROD with NOTICES
76610 Federal Register / Vol. 85, No. 230 / Monday, November 30, 2020 / Notices 

Basic class Final 2021 quotas 

(g) 

Alpha-Methylfentanyl ..................................................................................................................................................................... 30 

Alpha-Methylthiofentanyl ................................................................................................................................................................ 30 

Alpha-Methyltryptamine (AMT) ...................................................................................................................................................... 25 

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

Alpha-Pyrrolidinoheptaphenone (PV8) .......................................................................................................................................... 25 

Alpha-Pyrrolidinohexanophenone (a-PHP) ................................................................................................................................... 25 

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

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

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

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

Benzethidine .................................................................................................................................................................................. 25 

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

Betacetylmethadol ......................................................................................................................................................................... 25 

Beta-Hydroxy-3-methylfentanyl ...................................................................................................................................................... 30 

Beta-Hydroxyfentanyl ..................................................................................................................................................................... 30 

Beta-Hydroxythiofentanyl ............................................................................................................................................................... 30 

Betameprodine ............................................................................................................................................................................... 25 

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

Betaprodine .................................................................................................................................................................................... 25 

Bufotenine ...................................................................................................................................................................................... 15 

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

Butyryl fentanyl .............................................................................................................................................................................. 30 

Cathinone ....................................................................................................................................................................................... 40 

Clonitazene .................................................................................................................................................................................... 25 

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

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

Crotonyl fentanyl ............................................................................................................................................................................ 25 

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

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

Cyprenorphine ............................................................................................................................................................................... 25 

Delta 9–THC .................................................................................................................................................................................. 384,460 

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

Dextromoramide ............................................................................................................................................................................ 25 

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

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

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

Difenoxin ........................................................................................................................................................................................ 9,200 

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

Dimenoxadol .................................................................................................................................................................................. 25 

Dimepheptanol ............................................................................................................................................................................... 25 

Dimethylthiambutene ..................................................................................................................................................................... 20 

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

Dioxaphetyl butyrate ...................................................................................................................................................................... 25 

Dipipanone ..................................................................................................................................................................................... 25 

Drotebanol ..................................................................................................................................................................................... 25 

Ethylmethylthiambutene ................................................................................................................................................................. 25 

Ethylone ......................................................................................................................................................................................... 25 

Etonitazene .................................................................................................................................................................................... 25 

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

Etoxeridine ..................................................................................................................................................................................... 25 

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

Fentanyl related substances .......................................................................................................................................................... 600 

FUB–144 ........................................................................................................................................................................................ 25 

FUB–AKB48 ................................................................................................................................................................................... 25 

FUB–AMB, MMB-Fubinaca, AMB-Fubinaca ................................................................................................................................. 25 

Furanyl fentanyl ............................................................................................................................................................................. 30 

Furethidine ..................................................................................................................................................................................... 25 

Gamma Hydroxybutyric Acid ......................................................................................................................................................... 29,417,000 

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

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

Hydroxypethidine ........................................................................................................................................................................... 25 

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

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

Isotonitazene .................................................................................................................................................................................. 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 


TKELLEY on DSKBCP9HB2PROD with NOTICES
Federal Register / Vol. 85, No. 230 / Monday, November 30, 2020 / Notices 76611 

Basic class Final 2021 quotas 

(g) 

Ketobemidone ................................................................................................................................................................................ 30 

Levomoramide ............................................................................................................................................................................... 25 

Levophenacylmorphan ................................................................................................................................................................... 25 

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 

MMB–CHMICA (AMB–CHMICA); Methyl-2-(1-(cyclohexylmethyl)-1H-indole-3-carboxamido)-3-methylbutanoate ...................... 25 

Marihuana ...................................................................................................................................................................................... 1,500,000 

Marihuana extract .......................................................................................................................................................................... 200,000 

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

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

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

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

Methoxyacetyl fentanyl .................................................................................................................................................................. 30 

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

Methyldihydromorphine .................................................................................................................................................................. 25 

Morpheridine .................................................................................................................................................................................. 25 

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

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

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

MT–45 ............................................................................................................................................................................................ 30 

Myrophine ...................................................................................................................................................................................... 25 

NM2201; Naphthalen-1-yl 1-(5-fluoropentyl)-1H-indole-3-carboxylate .......................................................................................... 25 

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

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

N-Ethyl-1-phenylcyclohexylamine .................................................................................................................................................. 25 

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

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

N-Ethylhexedrone .......................................................................................................................................................................... 25 

N-Ethylpentylone, ephylone ........................................................................................................................................................... 30 

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

N-Methyl-3-Piperidyl Benzilate ...................................................................................................................................................... 30 

Nicocodeine ................................................................................................................................................................................... 25 

Nicomorphine ................................................................................................................................................................................. 25 

Noracymethadol ............................................................................................................................................................................. 25 

Norlevorphanol ............................................................................................................................................................................... 2,550 

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-methoxyphenylacetyl)indole) ................................................................................... 45 

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

Tetrahydrofuranyl fentanyl ............................................................................................................................................................. 15 

Thebacon ....................................................................................................................................................................................... 25 

Thiafentanil .................................................................................................................................................................................... 25 

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

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

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

Trimeperidine ................................................................................................................................................................................. 25 

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


TKELLEY on DSKBCP9HB2PROD with NOTICES
76612 Federal Register / Vol. 85, No. 230 / Monday, November 30, 2020 / Notices 

Basic class Final 2021 quotas 

(g) 

U–47700 ........................................................................................................................................................................................ 30 

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

Schedule II 

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

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

4-Anilino-N-phenethyl-4-piperidine (ANPP) ................................................................................................................................... 937,758 

Alfentanil ........................................................................................................................................................................................ 3,260 

Alphaprodine .................................................................................................................................................................................. 25 

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

Bezitramide .................................................................................................................................................................................... 25 

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

Cocaine .......................................................................................................................................................................................... 68,576 

Codeine (for conversion) ............................................................................................................................................................... 1,612,500 

Codeine (for sale) .......................................................................................................................................................................... 27,616,684 

D-amphetamine (for sale) .............................................................................................................................................................. 21,200,000 

D-amphetamine (for conversion) ................................................................................................................................................... 14,137,578 

D-methamphetamine (for conversion) ........................................................................................................................................... 485,02 

D-methamphetamine (for sale) ...................................................................................................................................................... 40,000 

D,L-amphetamine .......................................................................................................................................................................... 21,200,000 

D,L-methamphetamine .................................................................................................................................................................. 50 

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

Dihydrocodeine .............................................................................................................................................................................. 156,713 

Dihydroetorphine ............................................................................................................................................................................ 25 

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

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

Ecgonine ........................................................................................................................................................................................ 68,576 

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

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

Fentanyl ......................................................................................................................................................................................... 731,452 

Glutethimide ................................................................................................................................................................................... 25 

Hydrocodone (for conversion) ....................................................................................................................................................... 1,250 

Hydrocodone (for sale) .................................................................................................................................................................. 30,821,224 

Hydromorphone ............................................................................................................................................................................. 2,827,940 

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

L-amphetamine .............................................................................................................................................................................. 30 

L-methamphetamine ...................................................................................................................................................................... 587,229 

Levo-alphacetylmethadol (LAAM) .................................................................................................................................................. 25 

Levomethorphan ............................................................................................................................................................................ 30 

Levorphanol ................................................................................................................................................................................... 26,495 

Lisdexamfetamine .......................................................................................................................................................................... 21,000,000 

Meperidine ..................................................................................................................................................................................... 856,695 

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

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

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

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

Methadone (for sale) ..................................................................................................................................................................... 25,619,700 

Methadone Intermediate ................................................................................................................................................................ 27,673,600 

Methylphenidate ............................................................................................................................................................................. 57,438,334 

Metopon ......................................................................................................................................................................................... 25 

Moramide-intermediate .................................................................................................................................................................. 25 

Morphine (for conversion) .............................................................................................................................................................. 3,376,696 

Morphine (for sale) ........................................................................................................................................................................ 27,784,062 

Nabilone ......................................................................................................................................................................................... 62,000 

Norfentanyl ..................................................................................................................................................................................... 25 

Noroxymorphone (for conversion) ................................................................................................................................................. 22,044,741 

Noroxymorphone (for sale) ............................................................................................................................................................ 376,000 

Opium (powder) ............................................................................................................................................................................. 250,000 

Opium (tincture) ............................................................................................................................................................................. 530,837 

Oripavine ........................................................................................................................................................................................ 33,010,750 

Oxycodone (for conversion) .......................................................................................................................................................... 620,887 

Oxycodone (for sale) ..................................................................................................................................................................... 57,110,032 

Oxymorphone (for conversion) ...................................................................................................................................................... 28,204,371 

Oxymorphone (for sale) ................................................................................................................................................................. 563,174 

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

Phenazocine .................................................................................................................................................................................. 25 

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

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

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

Piminodine ..................................................................................................................................................................................... 25 

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

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


TKELLEY on DSKBCP9HB2PROD with NOTICES
Federal Register / Vol. 85, No. 230 / Monday, November 30, 2020 / Notices 76613 

Basic class Final 2021 quotas 

(g) 

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

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

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

Tapentadol ..................................................................................................................................................................................... 13,447,541 

Thebaine ........................................................................................................................................................................................ 57,137,944 

List I Chemicals 

Ephedrine (for conversion) ............................................................................................................................................................ 100 

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

Phenylpropanolamine (for conversion) .......................................................................................................................................... 14,878,320 

Phenylpropanolamine (for sale) ..................................................................................................................................................... 16,690,000 

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

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

The Administrator also establishes 

APQ 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 2021 APQ and AAN as 

needed. 

Timothy J. Shea, 

Acting Administrator. 

[FR Doc. 2020–26289 Filed 11–27–20; 8:45 am] 

BILLING CODE 4410–09–P 

NATIONAL SECURITY COMMISSION 

ON ARTIFICIAL INTELLIGENCE 

[Docket No. 11–2020–01] 

National Security Commission on 

Artificial Intelligence; Notice of Federal 

Advisory Committee Meeting 

AGENCY: National Security Commission 

on Artificial Intelligence. 

ACTION: Notice of Federal Advisory 

Committee meeting. 

SUMMARY: The National Security 

Commission on Artificial Intelligence 

(the ‘‘Commission’’) is publishing this 

notice to announce the following 

asynchronous Federal Advisory 

Committee meeting and paper review 

process. The meeting will be closed to 

the public. 

DATES: Closed to the public, December 

15, 2020 to February 14, 2021. 

FOR FURTHER INFORMATION CONTACT: Ms. 

Angela Ponmakha, 703–614–6379 

(Voice), nscai-dfo@nscai.gov. Mailing 

address: Designated Federal Officer, 

National Security Commission on 

Artificial Intelligence, 2530 Crystal 

Drive, Box 45, Arlington, VA 22202. 

website: https://www.nscai.gov. 

SUPPLEMENTARY INFORMATION: The 

meeting and paper review process are 

being held under the provisions of the 

Federal Advisory Committee Act 

(FACA) (5 U.S.C., Appendix), the 

Government in the Sunshine Act (5 

U.S.C. 552b), and 41 CFR 102–3.140 and 

102–3.150. 

Purpose of the Meeting: The John S. 

McCain National Defense Authorization 

Act for Fiscal Year 2019 (FY19 NDAA), 

Sec. 1051, Public Law 115–232, 132 

Stat. 1636, 1962–65 (2018), created the 

Commission to ‘‘consider the methods 

and means necessary to advance the 

development of artificial intelligence, 

machine learning, and associated 

technologies by the United States to 

comprehensively address the national 

security and defense needs of the 

United States.’’ The Commission will 

consider potential recommendations to 

Congress and the Executive Branch. 

According to the FY19 NDAA, the 

Commission ‘‘may include a classified 

annex.’’ 

Agenda: Due to the restrictions on inperson meetings imposed by the 

COVID–19 pandemic—including travel, 

social distancing, and other factors—the 

Commission will hold an asynchronous 

Federal Advisory Committee meeting 

beginning on or about December 15, 

2020 and ending on or about February 

14, 2020. For the asynchronous meeting, 

individual commissioners or small 

groups of commissioners will meet with 

Commission staff during this period of 

time to discuss and deliberate 

specifically on the Commission’s draft 

classified annex. The Designated 

Federal Officer, Ms. Angela Ponmakha, 

or an alternate designated federal officer 

will convene and conclude all such 

meetings. Due to the restrictions from 

the COVID–19 pandemic, 

Commissioners may also deliberate and 

vote on the classified annex through a 

paper approval process managed by the 

Designated Federal Officer and relevant 

Commission staff. All materials and 

discussions in the asynchronous 

meeting and paper approval process 

will be classified. 

Meeting Accessibility: In accordance 

with Section 10(d) of the FACA, NSCAI 

has determined the series of meetings 

and paper approval process will be 

closed to the public. Specifically, the 

Commission’s Committee Management 

Officer, in consultation with the General 

Services Administration’s Secretariat 

and Office of General Counsel, has 

determined in writing that the meetings 

will be closed to the public because they 

will consider matters covered by 5 

U.S.C. 552b(c)(1). The determination is 

because it is expected that discussions 

throughout the course of the 

asynchronous meeting and the paper 

approval process will involve classified 

matters of national security concern. 

Such classified material is so 

intertwined with the unclassified 

material that it cannot be reasonably 

segregated into separate discussions 

without defeating the effectiveness and 

meaning of the overall meetings. To 

permit the meeting to be open to the 

public would preclude discussion of 

such matters and would greatly 

diminish the ultimate utility of the 

Commission’s findings and 

recommendations to the Congress and 

the President. 

Written Statements: Written 

comments may be submitted to the 

Commission at any time regarding its 

mission or in response to the stated 

agenda of planned meetings via email 

to: nscai-dfo@nscai.gov in either Adobe 

Acrobat or Microsoft Word format. The 

DFO will compile all written 

submissions and provide them to the 

Commissioners for consideration. Please 

note that all submitted comments will 

be treated as public documents and will 

be made available for public inspection, 

including, but not limited to, being 

posted on the Commission’s website. 


TKELLEY on DSKBCP9HB2PROD with NOTICES