49346 Federal Register / Vol. 86, No. 168 / Thursday, September 2, 2021 / Notices 

Resideo Smart Homes Technology 

(Tianjin), Building 21, Jinbin 

Development Area, No. 156 Nanhai 

Road, Teda, Tianjin 300457, China. 

Resideo Technologies, Inc., 901 E. 6th 

Street, Austin, TX 78702. 

Xylem Inc., 1 International Drive, Rye 

Brook, NY 10573. 

(4) For the investigation so instituted, 

the Chief Administrative Law Judge, 

U.S. International Trade Commission, 

shall designate the presiding 

Administrative Law Judge. 

The Office of Unfair Import 

Investigations is not a party to this 

investigation. 

Responses to the amended complaint 

and the notice of investigation must be 

submitted by the named respondents in 

accordance with section 210.13 of the 

Commission’s Rules of Practice and 

Procedure, 19 CFR 210.13. Pursuant to 

19 CFR 201.16(e) and 210.13(a), as 

amended in 85 FR 15798 (March 19, 

2020), such responses will be 

considered by the Commission if 

received not later than 20 days after the 

date of service by the complainant of the 

complaint and the notice of 

investigation. Extensions of time for 

submitting responses to the complaint 

and the notice of investigation will not 

be granted unless good cause therefor is 

shown. 

Failure of a respondent to file a timely 

response to each allegation in the 

complaint and in this notice may be 

deemed to constitute a waiver of the 

right to appear and contest the 

allegations of the amended complaint 

and this notice, and to authorize the 

administrative law judge and the 

Commission, without further notice to 

the respondent, to find the facts to be as 

alleged in the amended complaint and 

this notice and to enter an initial 

determination and a final determination 

containing such findings, and may 

result in the issuance of an exclusion 

order or a cease and desist order or both 

directed against the respondent. 

By order of the Commission. 

Issued: August 27, 2021. 

Katherine Hiner, 

Supervisory Attorney. 

[FR Doc. 2021–18929 Filed 9–1–21; 8:45 am] 

BILLING CODE 7020–02–P 

DEPARTMENT OF JUSTICE 

Drug Enforcement Administration 

[Docket No. DEA–688A] 

Proposed Adjustments to the 

Aggregate Production Quotas for 

Schedule I and II Controlled 

Substances and Assessment of 

Annual Needs for the List I Chemicals 

Ephedrine, Pseudoephedrine, and 

Phenylpropanolamine for 2021 

AGENCY: Drug Enforcement 

Administration, Department of Justice. 

ACTION: Notice with request for 

comments. 

SUMMARY: The Drug Enforcement 

Administration proposes to adjust the 

2021 aggregate production quotas for 

several controlled substances in 

schedules I and II of the Controlled 

Substances Act and assessment of 

annual needs for the list I chemicals 

ephedrine, pseudoephedrine, and 

phenylpropanolamine. 

DATES: Interested persons may file 

written comments on this notice in 

accordance with 21 CFR 1303.13(c) and 

1315.13(d). Electronic comments must 

be submitted, and written comments 

must be postmarked, on or before 

October 4, 2021. Commenters should be 

aware that the electronic Federal Docket 

Management System will not accept 

comments after 11:59 p.m. Eastern Time 

on the last day of the comment period. 

Based on comments received in 

response to this notice, the 

Administrator may hold a public 

hearing on one or more issues raised. In 

the event the Administrator decides in 

her sole discretion to hold such a 

hearing, the Administrator will publish 

a notice of any such hearing in the 

Federal Register. After consideration of 

any comments or objections, or after a 

hearing, if one is held, the 

Administrator will publish in the 

Federal Register a final order 

establishing the 2021 adjusted aggregate 

production quotas for schedule I and II 

controlled substances, and an adjusted 

assessment of annual needs for the list 

I chemicals ephedrine, 

pseudoephedrine, and 

phenylpropanolamine. 

ADDRESSES: To ensure proper handling 

of comments, please reference ‘‘Docket 

No. DEA–688A’’ on all correspondence, 

including any attachments. DEA 

encourages that all comments be 

submitted electronically through the 

Federal eRulemaking Portal which 

provides the ability to type short 

comments directly into the comment 

field on the web page or attach a file for 

lengthier comments. Please go to http:// 

www.regulations.gov and follow the 

online instructions at that site for 

submitting comments. Upon completion 

of your submission, you will receive a 

Comment Tracking Number for your 

comment. Please be aware that 

submitted comments are not 

instantaneously available for public 

view on Regulations.gov. If you have 

received a Comment Tracking Number, 

your comment has been successfully 

submitted and there is no need to 

resubmit the same comment. Paper 

comments that duplicate electronic 

submissions are not necessary and are 

discouraged. Should you wish to mail a 

paper comment in lieu of an electronic 

comment, it should be sent via regular 

or express mail to: Drug Enforcement 

Administration, Attention: DEA Federal 

Register Representative/DRW, 8701 

Morrissette Drive, Springfield, Virginia 

22152. 

FOR FURTHER INFORMATION CONTACT: 

Scott A. Brinks, Regulatory Drafting and 

Policy Support Section, Diversion 

Control Division, Drug Enforcement 

Administration; Mailing Address: 8701 

Morrissette Drive, Springfield, Virginia 

22152, Telephone: (571) 776–2265. 

SUPPLEMENTARY INFORMATION: 

Posting of Public Comments 

Please note that all comments 

received in response to this docket are 

considered part of the public record. 

They will, unless reasonable cause is 

given, be made available by the Drug 

Enforcement Administration (DEA) for 

public inspection online at http://

www.regulations.gov. Such information 

includes personal identifying 

information (such as your name, 

address, etc.) voluntarily submitted by 

the commenter. 

The Freedom of Information Act 

applies to all comments received. If you 

want to submit personal identifying 

information (such as your name, 

address, etc.) as part of your comment, 

but do not want it to be made publicly 

available, you must include the phrase 

‘‘PERSONAL IDENTIFYING 

INFORMATION’’ in the first paragraph 

of your comment. You must also place 

all the personal identifying information 

you do not want made publicly 

available in the first paragraph of your 

comment and identify what information 

you want redacted. 

If you want to submit confidential 

business information as part of your 

comment, but do not want it to be made 

publicly available, you must include the 

phrase ‘‘CONFIDENTIAL BUSINESS 

INFORMATION’’ in the first paragraph 

of your comment. You must also 


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Federal Register / Vol. 86, No. 168 / Thursday, September 2, 2021 / Notices 49347 

prominently identify confidential 

business information to be redacted 

within the comment. 

Comments containing personal 

identifying information or confidential 

business information identified and 

located as directed above will generally 

be made available in redacted form. If a 

comment contains so much confidential 

business information or personal 

identifying information that it cannot be 

effectively redacted, all or part of that 

comment may not be made publicly 

available. Comments posted to http://

www.regulations.gov may include any 

personal identifying information (such 

as name, address, and phone number) 

included in the text of your electronic 

submission that is not identified as 

directed above as confidential. 

An electronic copy of this document 

is available at http://

www.regulations.gov for easy reference. 

Legal Authority and Background 

Section 306 of the Controlled 

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

requires the Attorney General to 

establish aggregate production quotas 

for each basic class of controlled 

substance listed in schedules I and II 

and for the list I chemicals ephedrine, 

pseudoephedrine, and 

phenylpropanolamine. The Attorney 

General has delegated this function to 

the Administrator of DEA pursuant to 

28 CFR 0.100. 

DEA established the 2021 aggregate 

production quotas for substances in 

schedules I and II and the assessment of 

annual needs for the list I chemicals 

ephedrine, pseudoephedrine, and 

phenylpropanolamine on November 30, 

2020 (85 FR 76604). That order 

stipulated that, in accordance with 21 

CFR 1303.13 and 1315.13, all aggregate 

production quotas and assessments of 

annual need are subject to adjustment. 

Analysis for Proposed Adjusted 2021 

Aggregate Production Quotas and 

Assessment of Annual Needs 

DEA proposes to adjust the 

established 2021 aggregate production 

quotas to be manufactured in the United 

States in 2021 to provide for the 

estimated medical, scientific, research, 

and industrial needs of the United 

States, for lawful export requirements, 

and for the establishment and 

maintenance of reserve stocks. These 

quotas do not include imports of 

controlled substances for use in 

industrial processes. However, DEA’s 

analysis does not suggest the need for 

adjustment of the 2021 assessment of 

annual needs for the List I chemicals. 

Factors for Determining the Proposed 

Adjustments 

In determining the proposed 

adjustments, the Administrator has 

taken into account the criteria in 

accordance with 21 CFR 1303.13 

(adjustment of aggregate production 

quotas for controlled substances) and 21 

CFR 1315.13 (adjustment of the 

assessment of annual needs for 

ephedrine, pseudoephedrine, and 

phenylpropanolamine). The 

Administrator is authorized to increase 

or reduce the aggregate production 

quota at any time. 21 CFR 1303.13(a) 

and 1315.13(a). DEA regulations state 

that there are five factors that shall be 

considered in determining to adjust the 

aggregate production quota and the 

assessment of annual needs. 21 CFR 

1303.13(b) and 1315.13(b). 

DEA determined whether to propose 

an adjustment of the aggregate 

production quotas and assessment of 

annual needs for 2021 by considering 

the factors summarized below: 

(1) Changes in the demand for that class or 

chemical, changes in the national rate of net 

disposal of the class or chemical, changes in 

the national rate of net disposal of the class 

or chemical by registrants holding individual 

manufacturing quotas for that class or 

chemical, and changes in the extent of any 

diversion in the class of controlled substance; 

(2) whether any increased demand for that 

class or chemical, the national and/or 

individual rates of net disposal of that class 

or chemical are temporary, short term, or 

long term; 

(3) whether any increased demand for that 

class or chemical can be met through existing 

inventories, increased individual 

manufacturing quotas, or increased 

importation, without increasing the aggregate 

production quota or assessment of annual 

needs, taking into account production delays 

and the probability that other individual 

manufacturing quotas may be suspended 

pursuant to Sec. 1303.24(b) and 1315.24(b); 

(4) whether any decreased demand for that 

class or chemical will result in excessive 

inventory accumulation by all persons 

registered to handle that class or chemical 

(including manufacturers, distributors, 

practitioners, importers, and exporters), 

notwithstanding the possibility that 

individual manufacturing quotas may be 

suspended pursuant to Sec. 1303.24(b) and 

1315.24(b) or abandoned pursuant to Sec. 

1303.27 and 1315.27; and 

(5) other factors affecting medical, 

scientific, research, and industrial needs in 

the United States, lawful export 

requirements, and other factors affecting 

importation needs of listed chemicals in the 

United States as the Administrator finds 

relevant, including changes in the currently 

accepted medical use in treatment with the 

class or the substances which are 

manufactured from it, the economic and 

physical availability of raw materials for use 

in manufacturing and for inventory purposes, 

yield and stability problems, potential 

disruptions to production (including possible 

labor strikes), and recent unforeseen 

emergencies such as floods and fires. 21 CFR 

1303.13(b) and 1315(b). 

DEA considered the change in the 

extent of diversion of all controlled 

substances in proposing adjustments to 

the aggregate production quotas as 

required by 21 CFR 1303.13(b)(1). 

Pursuant to these factors, DEA has 

determined that any calculated changes 

from the previously determined initial 

calculations are slight and not 

statistically significant from the 

quantities originally calculated for the 

extent of diversion that were applied to 

the initial aggregate production quota 

valuations. 

DEA also considered updated 

information obtained from 2020 yearend inventories, 2020 disposition data 

submitted by quota applicants, 

estimates of the medical needs of the 

United States, product development, 

and other information made available to 

DEA after the initial aggregate 

production quotas and assessment of 

annual needs had been established. 

Other factors the Administrator 

considered in calculating the aggregate 

production quotas, but not the 

assessment of annual needs, include 

product development requirements of 

both bulk and finished dosage form 

manufacturers, and other pertinent 

information. 

In evaluating whether there is a need 

for adjustment of the 2021 assessment of 

annual needs for List I chemicals, DEA 

used the calculation methodology 

previously described in the 2010 and 

2011 assessment of annual needs (74 FR 

60294, Nov. 20, 2009, and 75 FR 79407, 

Dec. 20, 2010, respectively). However, 

DEA’s analysis does not suggest the 

need for adjustment of the 2021 

assessment of annual needs. 

Considerations Based Upon the 

Substance Use-Disorder Prevention That 

Promotes Opioid Recovery and 

Treatment for Patients and 

Communities Act 

Pursuant to 21 U.S.C. 826(a)(1), 

‘‘production quotas shall be established 

in terms of quantities of each basic class 

of controlled substance and not in terms 

of individual pharmaceutical dosage 

forms prepared from or containing such 

a controlled substance.’’ However, the 

Substance Use-Disorder Prevention that 

Promotes Opioid Recovery Treatment 

for Patients and Communities Act of 

2018 (SUPPORT Act), (Pub. L. 115–271), 

provides an exception to that general 

rule by now giving DEA the authority to 

establish quotas in terms of 

pharmaceutical dosage forms if the 


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49348 Federal Register / Vol. 86, No. 168 / Thursday, September 2, 2021 / Notices 

1All functions vested in the Attorney General by 

the CSA have been delegated to the Administrator 

of DEA. 28 CFR 0.100(b). 

agency determines that doing so will 

assist in avoiding the overproduction, 

shortages, or diversion of a controlled 

substance. 

DEA has stated before that while there 

is the authority to set aggregate 

production quotas in terms of 

pharmaceutical dosage form, DEA will 

not be using that authority at this time. 

Furthermore, when DEA does utilize the 

authority, it will be doing so at the 

individual dosage-form manufacturing 

level, as that is where it is most 

appropriate to do so. As such, there are 

no adjustments to set any controlled 

substances in terms of pharmaceutical 

dosage forms. 

Under the SUPPORT Act, when 

setting the aggregate production quota, 

DEA must estimate the amount of 

diversion of any substance that is 

considered a ‘‘covered controlled 

substance,’’ as defined by the SUPPORT 

Act. 21 U.S.C. 826(i)(1)(A). The covered 

controlled substances are fentanyl, 

oxycodone, hydrocodone, 

oxymorphone, and hydromorphone. 

The SUPPORT Act also requires DEA to 

‘‘make appropriate quota reductions, as 

determined by the [Administrator],1

from the quota the [Administrator] 

would have otherwise established had 

such diversion not been considered.’’ 21 

U.S.C. 826(i)(1)(C). When estimating 

diversion, the ‘‘[Administrator]—(i) 

shall consider information the 

[Administrator], in consultation with 

the Secretary of Health and Human 

Services, determines reliable on rates of 

overdose deaths and abuse and overall 

public health impact related to the 

covered controlled substance in the 

United States; and (ii) may take into 

consideration whatever other sources of 

information the [Administrator] 

determines reliable.’’ 21 U.S.C. 

826(i)(1)(B). 

In February 2021, DEA sent letters to 

the Centers for Disease Control and 

Prevention (CDC), Centers for Medicare 

and Medicaid Services (CMS), and the 

states requesting overdose death and 

overprescribing data that could be 

considered for estimating diversion. 

DEA did not receive information from 

CMS. However, DEA did receive 

information from the CDC in June 2021 

and has started to receive information 

from the states. DEA has begun to 

receive Prescription Drug Monitoring 

Program (PDMP) data from the states in 

a format that will allow the Agency to 

develop a more robust methodology to 

assist in the determination of the 

diversion estimate in the future. This 

information will be considered in 

determining the estimates of diversion 

for the five covered controlled 

substances in the Proposed Aggregate 

Production Quotas for Schedule I and II 

Controlled Substances and Assessment 

of Annual Needs for the List I Chemicals 

Ephedrine, Pseudoephedrine, and 

Phenylpropanolamine for 2022. 

To update the estimates of diversion, 

DEA used data from the Drug Theft and 

Loss Report, Statistical Management 

Analysis & Reporting Tools System 

(SMARTS), and System to Retrieve 

Information on Drug Evidence (STRIDE) 

databases to aggregate the active 

pharmaceutical ingredient (API) of each 

covered controlled substance by metric 

weight. From the databases, DEA 

gathered data involving employee theft, 

break-ins, armed robberies, and material 

lost in transit. DEA also used seizure 

data obtained from reports submitted by 

law enforcement agencies nationwide. 

This data was categorized by basic drug 

class and the amount of API in the 

dosage form was delineated with an 

appropriate metric for use in proposing 

the adjusted aggregate production quota 

values. Using the data, DEA calculated 

the estimates for the amount of 

diversion by multiplying the strength of 

the API listed for each finished dosage 

form by the total amount of units 

reported to estimate the metric weight 

in grams of the controlled substance 

being diverted. Below, DEA has updated 

the chart to include estimations of 

diversion for each of the covered 

controlled substances. 

Diversion estimates for 2020 (g) 

Fentanyl ........................................ 184 

Hydrocodone ................................ 20,759 

Hydromorphone ............................ 946 

Oxycodone .................................... 47,316 

Oxymorphone ............................... 534 

DEA considered the change in the 

extent of diversion of all controlled 

substances in proposing adjustments to 

the aggregate production quotas as 

required by 21 CFR 1303.13(b)(1). 

Pursuant to these factors, DEA has 

determined that any calculated changes 

from the previously determined initial 

calculations are slight and not 

statistically significant from the 

quantities originally calculated for the 

extent of diversion that were applied to 

the initial aggregate production quota 

valuations. 

Proposed Adjustments for the 2021 

Aggregate Production Quotas and 

Assessment of Annual Needs 

DEA is proposing significant increases 

to the APQs of the schedule I substances 

psilocybin, psilocin, marihuana, and 

marihuana extract, which are directly 

related to increased interest by DEA 

registrants in the use of hallucinogenic 

controlled substances for research and 

clinical trial purposes. DEA firmly 

believes in supporting regulated 

research of schedule I controlled 

substances. Therefore, the APQ 

increases reflect the need to fulfill 

research and development requirements 

in the production of new drug products, 

and the study of marijuana effects in 

particular, as necessary steps toward 

potential Food and Drug Administration 

(FDA) approval of new drug products. 

The DEA established the 2021 

aggregate production quotas for 

substances in schedules I and II on 

November 30, 2020 (85 FR 76604). 

Subsequent to that publication, DEA 

published in the Federal Register two 

final rules to permanently schedule 14 

specific fentanyl-related substances 

under the CSA (86 FR 22113, April 27, 

2021, and 86 FR 23602, May 4, 2021). 

The specific fentanyl-related substances 

are 2′-fluoro 2-fluorofentanyl, 4′-Methyl 

acetyl fentanyl, beta-Methyl fentanyl, 

beta-Phenyl fentanyl, Fentanyl 

carbamate, ortho-Fluoroacryl fentanyl, 

ortho-Fluorobutyryl fentanyl, orthoFluoroisobutyryl fentanyl, ortho-Methyl 

acetylfentanyl, ortho-Methyl 

methoxyacetyl fentanyl, para-Fluoro 

furanyl fentanyl, para-Methylfentanyl, 

Phenyl fentanyl, and Thiofuranyl 

fentanyl. As a result, these substances 

will continue to be subject to the CSA 

schedule I controls and are now being 

assigned individual aggregate 

production quotas. 

On March 1, 2021, DEA published a 

temporary scheduling order placing 

Brorphine in schedule I of the CSA (86 

FR 11862), making all regulatory 

controls pertaining to schedule I 

controlled substances applicable to the 

manufacture of these substances, 

including the requirement to establish 

an aggregate production quota pursuant 

to 21 U.S.C. 826 and 21 CFR part 1303. 

This notice proposes to establish an 

aggregate production quota for this 

substance. 

On May 7, 2021, DEA published an 

interim final rule placing 

serdexmethylphenidate, a component in 

a combination drug product recently 

approved by FDA for the treatment of 

ADHD in patients six years of age and 

older, in schedule IV of the CSA (86 FR 

24487). Serdexmethylphenidate is 

manufactured from methylphenidate, a 

schedule II controlled substance. In 

order to more accurately estimate and 

manage the quantity of methylphenidate 

necessary for direct formulation into 

schedule II drug products versus the 


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Federal Register / Vol. 86, No. 168 / Thursday, September 2, 2021 / Notices 49349 

quantity of methylphenidate necessary 

for the manufacturing of 

serdexmethylphenidate or other 

substances, DEA has delineated 

methylphenidate into methylphenidate 

(for sale) and methylphenidate (for 

conversion). This notice proposes to 

establish an aggregate production quota 

for methylphenidate (for conversion). 

On June 20, 2021, DEA published the 

final rule to place oliceridine, a 

medication recently approved by FDA 

for medical use as an intravenous drug 

for the management of acute pain severe 

enough to require an intravenous opioid 

analgesic and for patients for whom 

alternative treatments are inadequate, in 

schedule II of the CSA effective July 12, 

2021 (86 FR 30772). The placement of 

oliceridine in schedule II of the CSA, 

makes all regulatory controls pertaining 

to schedule II controlled substances 

applicable to the manufacture of this 

substance, including the requirement to 

establish an aggregate production quota 

pursuant to 21 U.S.C. 826 and 21 CFR 

part 1303. 

The Administrator, therefore, 

proposes to adjust the 2021 aggregate 

production quotas for certain schedule I 

and II controlled substances. The 

Administrator does not propose an 

adjustment to the assessments of annual 

needs for the list I chemicals ephedrine, 

pseudoephedrine, and 

phenylpropanolamine. The proposed 

adjusted APQs, as expressed in grams of 

anhydrous acid or base, are as follows: 

Basic class 

Established 

2021 

quotas 

Proposed 

revised 

2021 

quotas 

(g) (g) 

Temporarily Scheduled 

Brorphine ......................................................................................................................................................................... N/A 30. 

Schedule I 

1-[1-(2-Thienyl)cyclohexyl]pyrrolidine .............................................................................................................................. 20 no change. 

1-(1-Phenylcyclohexyl)pyrrolidine .................................................................................................................................... 15 30. 

1-(2-Phenylethyl)-4-phenyl-4-acetoxypiperidine .............................................................................................................. 10 no change. 

1-(5-Fluoropentyl)-3-(1-naphthoyl)indole (AM2201) ........................................................................................................ 30 no change. 

1-(5-Fluoropentyl)-3-(2-iodobenzoyl)indole (AM694) ...................................................................................................... 30 no change. 

1-Benzylpiperazine .......................................................................................................................................................... 25 no change. 

1-Methyl-4-phenyl-4-propionoxypiperidine ...................................................................................................................... 10 no change. 

1-[1-(2-Thienyl)cyclohexyl]piperidine ............................................................................................................................... 15 no change. 

2′-fluoro 2-fluorofentanyl .................................................................................................................................................. N/A 30. 

2-(2,5-Dimethoxy-4-ethylphenyl)ethanamine (2C-E) ....................................................................................................... 30 no change. 

2-(2,5-Dimethoxy-4-methylphenyl)ethanamine (2C-D) .................................................................................................... 30 no change. 

2-(2,5-Dimethoxy-4-nitro-phenyl)ethanamine (2C-N) ...................................................................................................... 30 no change. 

2-(2,5-Dimethoxy-4-n-propylphenyl)ethanamine (2C-P) ................................................................................................. 30 no change. 

2-(2,5-Dimethoxyphenyl)ethanamine (2C-H) ................................................................................................................... 100 no change. 

2-(4-Bromo-2,5-dimethoxyphenyl)-N-(2-methoxybenzyl)ethanamine (25B-NBOMe; 2C-B-NBOMe; 25B; Cimbi-36) .... 30 no change. 

2-(4-Chloro-2,5-dimethoxyphenyl)ethanamine (2C-C) .................................................................................................... 30 no change. 

2-(4-Chloro-2,5-dimethoxyphenyl)-N-(2-methoxybenzyl)ethanamine (25C-NBOMe; 2C-C-NBOMe; 25C; Cimbi-82) ... 25 no change. 

2-(4-Iodo-2,5-dimethoxyphenyl)ethanamine (2C-I) ......................................................................................................... 30 no change. 

2-(4-Iodo-2,5-dimethoxyphenyl)-N-(2-methoxybenzyl)ethanamine (25I-NBOMe; 2C-I-NBOMe; 25I; Cimbi-5) .............. 30 no change. 

2,5-Dimethoxy-4-ethylamphetamine (DOET) .................................................................................................................. 25 no change. 

2,5-Dimethoxy-4-n-propylthiophenethylamine ................................................................................................................. 25 no change. 

2,5-Dimethoxyamphetamine (DMA) ................................................................................................................................ 25 no change. 

2-[4-(Ethylthio)-2,5-dimethoxyphenyl]ethanamine (2C-T-2) ............................................................................................ 30 no change. 

2-[4-(Isopropylthio)-2,5-dimethoxyphenyl]ethanamine (2C-T-4) ...................................................................................... 30 no change. 

3,4,5-Trimethoxyamphetamine ........................................................................................................................................ 30 no change. 

3,4-Methylenedioxyamphetamine (MDA) ........................................................................................................................ 55 no change. 

3,4-Methylenedioxymethamphetamine (MDMA) ............................................................................................................. 50 no change. 

3,4-Methylenedioxy-N-ethylamphetamine (MDEA) ......................................................................................................... 40 no change. 

3,4-Methylenedioxy-N-methylcathinone (methylone) ...................................................................................................... 40 no change. 

3,4-Methylenedioxypyrovalerone (MDPV) ....................................................................................................................... 35 no change. 

3-FMC; 3-Fluoro-N-methylcathinone ............................................................................................................................... 25 no change. 

3-Methylfentanyl .............................................................................................................................................................. 30 no change. 

3-Methylthiofentanyl ......................................................................................................................................................... 30 no change. 

4′-Methyl acetyl fentanyl .................................................................................................................................................. N/A 30. 

4-Bromo-2,5-dimethoxyamphetamine (DOB) .................................................................................................................. 30 no change. 

4-Bromo-2,5-dimethoxyphenethylamine (2-CB) .............................................................................................................. 25 no change. 

4-Chloro-a-pyrrolidinovalerophenone (4-chloro-alpha-PVP) ........................................................................................... 25 no change. 

4CN-Cumyl-Butanica, 1-(4-Cyanobutyl)-N-(2-phenylpropan-2-yl)-1H-indazole-3-carboximide ...................................... 25 no change. 

4-Fluoroisobutyryl fentanyl .............................................................................................................................................. 30 no change. 

4-FMC; Flephedrone ....................................................................................................................................................... 25 no change. 

4-MEC; 4-Methyl-N-ethylcathinone ................................................................................................................................. 25 no change. 

4-Methoxyamphetamine .................................................................................................................................................. 150 no change. 

4-Methyl-2,5-dimethoxyamphetamine (DOM) ................................................................................................................. 25 no change. 

4-Methylaminorex ............................................................................................................................................................ 25 no change. 

4-Methyl-N-methylcathinone (mephedrone) .................................................................................................................... 45 no change. 

4-Methyl-a-ethylaminopentiophenone (4-MEAP) ............................................................................................................ 25 no change. 

4-Methyl-a-pyrrolidinohexiophenone (MPHP) ................................................................................................................. 25 no change. 

4-Methyl-a-pyrrolidinopropiophenone (4-MePPP) ........................................................................................................... 25 no change. 


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Basic class 

Established 

2021 

quotas 

Proposed 

revised 

2021 

quotas 

(g) (g) 

5-(1,1-Dimethylheptyl)-2-[(1R,3S)-3-hydroxycyclohexyl]-phenol ..................................................................................... 50 no change. 

5-(1,1-Dimethyloctyl)-2-[(1R,3S)-3-hydroxycyclohexyl]-phenol (cannabicyclohexanol or CP-47,497 C8-homolog) ....... 40 no change. 

5F-CUMYL-PINACA ........................................................................................................................................................ 25 no change. 

5F-EDMB-PINACA .......................................................................................................................................................... 25 no change. 

5F-MDMB-PICA ............................................................................................................................................................... 25 no change. 

5F-AB-PINACA; N-(1-amino-3-methyl-1-oxobutan-2-yl)-1-(5-fluoropentyl)-1H-indazole-3-carboxamide ....................... 25 no change. 

5F-CUMYL-P7AICA; (1-(5-fluoropentyl)-N-(2-phenylpropan-2-yl)-1H-pyrrolo[2,3-b]pyridine-3-carboximide) ................. 25 no change. 

5F-ADB; 5F-MDMB-PINACA (methyl 2-(1-(5-fluoropentyl)-1H-indazole-3-carboxamido)-3,3-dimethylbutanoate) ........ 30 no change. 

5F-AMB (methyl 2-(1-(5-fluoropentyl)-1H-indazole-3-carboxamido)-3-methylbutanoate) ............................................... 30 no change. 

5F-APINACA; 5F-AKB48 (N-(adamantan-1-yl)-1-(5-fluoropentyl)-1H-indazole-3-carboxamide) .................................... 30 no change. 

5-Fluoro-PB-22; 5F-PB-22 ............................................................................................................................................... 20 no change. 

5-Fluoro-UR144, XLR11 ([1-(5-fluoro-pentyl)-1H-indol-3-yl](2,2,3,3-tetramethylcyclopropyl)methanone ....................... 25 no change. 

5-Methoxy-3,4-methylenedioxyamphetamine .................................................................................................................. 25 no change. 

5-Methoxy-N,N-diisopropyltryptamine ............................................................................................................................. 25 no change. 

5-Methoxy-N,N-dimethyltryptamine ................................................................................................................................. 35 no change. 

AB-CHMINACA ................................................................................................................................................................ 30 no change. 

AB-FUBINACA ................................................................................................................................................................. 50 no change. 

AB-PINACA ..................................................................................................................................................................... 30 no change. 

ADB-FUBINACA (N-(1-amino-3,3-dimethyl-1-oxobutan-2-yl)-1-(4-fluorobenzyl)-1H-indazole-3-carboxamide) ............. 30 no change. 

Acetorphine ...................................................................................................................................................................... 25 no change. 

Acetyl Fentanyl ................................................................................................................................................................ 100 no change. 

Acetyl-alpha-methylfentanyl ............................................................................................................................................. 30 no change. 

Acetyldihydrocodeine ....................................................................................................................................................... 30 no change. 

Acetylmethadol ................................................................................................................................................................ 25 no change. 

Acryl Fentanyl .................................................................................................................................................................. 25 no change. 

ADB-PINACA (N-(1-amino-3,3-dimethyl-1-oxobutan-2-yl)-1-pentyl-1H-indazole-3-carboxamide) .................................. 50 no change. 

AH-7921 ........................................................................................................................................................................... 30 no change. 

All other tetrahydrocannabinol ......................................................................................................................................... 1,000 no change. 

Allylprodine ...................................................................................................................................................................... 25 no change. 

Alphacetylmethadol ......................................................................................................................................................... 25 no change. 

alpha-Ethyltryptamine ...................................................................................................................................................... 25 no change. 

Alphameprodine ............................................................................................................................................................... 25 no change. 

Alphamethadol ................................................................................................................................................................. 25 no change. 

Alphaprodine .................................................................................................................................................................... 25 no change. 

alpha-Methylfentanyl ........................................................................................................................................................ 30 no change. 

alpha-Methylthiofentanyl .................................................................................................................................................. 30 no change. 

alpha-Methyltryptamine (AMT) ........................................................................................................................................ 25 no change. 

alpha-Pyrrolidinobutiophenone (a-PBP) .......................................................................................................................... 25 no change. 

alpha-Pyrrolidinoheptaphenone (PV8) ............................................................................................................................ 25 no change. 

alpha-Pyrrolidinohexanophenone (a-PHP) ..................................................................................................................... 25 no change. 

alpha-Pyrrolidinopentiophenone (a-PVP) ........................................................................................................................ 25 no change. 

Aminorex .......................................................................................................................................................................... 25 no change. 

Anileridine ........................................................................................................................................................................ 20 no change. 

APINCA, AKB48 (N-(1-adamantyl)-1-pentyl-1H-indazole-3-carboxamide) ..................................................................... 25 no change. 

Benzethidine .................................................................................................................................................................... 25 no change. 

Benzylmorphine ............................................................................................................................................................... 30 no change. 

Betacetylmethadol ........................................................................................................................................................... 25 no change. 

beta-Hydroxy-3-methylfentanyl ........................................................................................................................................ 30 no change. 

beta-Hydroxyfentanyl ....................................................................................................................................................... 30 no change. 

beta-Hydroxythiofentanyl ................................................................................................................................................. 30 no change. 

beta-Methyl fentanyl ........................................................................................................................................................ N/A 30. 

beta-Phenyl fentanyl ........................................................................................................................................................ N/A 30. 

Betameprodine ................................................................................................................................................................ 25 no change. 

Betamethadol ................................................................................................................................................................... 4 no change. 

Betaprodine ..................................................................................................................................................................... 25 no change. 

Bufotenine ........................................................................................................................................................................ 15 no change. 

Butylone ........................................................................................................................................................................... 25 no change. 

Butyryl fentanyl ................................................................................................................................................................ 30 no change. 

Cathinone ........................................................................................................................................................................ 40 no change. 

Clonitazene ...................................................................................................................................................................... 25 no change. 

Codeine methylbromide ................................................................................................................................................... 30 no change. 

Codeine-N-oxide .............................................................................................................................................................. 192 no change. 

Cyclopentyl Fentanyl ....................................................................................................................................................... 30 no change. 

Cyclopropyl Fentanyl ....................................................................................................................................................... 20 no change. 

Cyprenorphine ................................................................................................................................................................. 25 no change. 

d-9-THC ........................................................................................................................................................................... 384,460 no change. 

Desomorphine ................................................................................................................................................................. 25 no change. 

Dextromoramide .............................................................................................................................................................. 25 no change. 

Diapromide ...................................................................................................................................................................... 20 no change. 

Diethylthiambutene .......................................................................................................................................................... 20 no change. 


lotter on DSK11XQN23PROD with NOTICES1
Federal Register / Vol. 86, No. 168 / Thursday, September 2, 2021 / Notices 49351 

Basic class 

Established 

2021 

quotas 

Proposed 

revised 

2021 

quotas 

(g) (g) 

Diethyltryptamine ............................................................................................................................................................. 25 no change. 

Difenoxin .......................................................................................................................................................................... 9,200 no change. 

Dihydromorphine ............................................................................................................................................................. 753,500 no change. 

Dimenoxadol .................................................................................................................................................................... 25 no change. 

Dimepheptanol ................................................................................................................................................................. 25 no change. 

Dimethylthiambutene ....................................................................................................................................................... 20 no change. 

Dimethyltryptamine .......................................................................................................................................................... 50 no change. 

Dioxyaphetyl butyrate ...................................................................................................................................................... 25 no change. 

Dipipanone ....................................................................................................................................................................... 25 no change. 

Drotebanol ....................................................................................................................................................................... 25 no change. 

Ethylmethylthiambutene .................................................................................................................................................. 25 no change. 

Etorphine ......................................................................................................................................................................... 30 no change. 

Etoxeridine ....................................................................................................................................................................... 25 no change. 

Fenethylline ..................................................................................................................................................................... 30 no change. 

Fentanyl carbamate ......................................................................................................................................................... N/A 30. 

Fentanyl related substances ........................................................................................................................................... 600 no change. 

FUB-144 .......................................................................................................................................................................... 25 no change. 

FUB-AKB48 ..................................................................................................................................................................... 25 no change. 

FUB-AMB, MMB-Fubinaca, AMB-Fubinaca .................................................................................................................... 25 no change. 

Furanyl fentanyl ............................................................................................................................................................... 30 no change. 

Furethidine ....................................................................................................................................................................... 25 no change. 

gamma-Hydroxybutyric acid ............................................................................................................................................ 29,417,000 no change. 

Heroin .............................................................................................................................................................................. 45 no change. 

Hydromorphinol ............................................................................................................................................................... 40 no change. 

Hydroxypethidine ............................................................................................................................................................. 25 no change. 

Ibogaine ........................................................................................................................................................................... 30 no change. 

Isobutyryl Fentanyl .......................................................................................................................................................... 25 no change. 

JWH-018 and AM678 (1-Pentyl-3-(1-naphthoyl)indole) .................................................................................................. 35 no change. 

JWH-019 (1-Hexyl-3-(1-naphthoyl)indole) ....................................................................................................................... 45 no change. 

JWH-073 (1-Butyl-3-(1-naphthoyl)indole) ........................................................................................................................ 45 no change. 

JWH-081 (1-Pentyl-3-[1-(4-methoxynaphthoyl)]indole) ................................................................................................... 30 no change. 

JWH-122 (1-Pentyl-3-(4-methyl-1-naphthoyl)indole) ....................................................................................................... 30 no change. 

JWH-200 (1-[2-(4-Morpholinyl)ethyl]-3-(1-naphthoyl)indole) ........................................................................................... 35 no change. 

JWH-203 (1-Pentyl-3-(2-chlorophenylacetyl)indole) ........................................................................................................ 30 no change. 

JWH-250 (1-Pentyl-3-(2-methoxyphenylacetyl)indole) .................................................................................................... 30 no change. 

JWH-398 (1-Pentyl-3-(4-chloro-1-naphthoyl)indole) ........................................................................................................ 30 no change. 

Ketobemidone .................................................................................................................................................................. 30 no change. 

Levomoramide ................................................................................................................................................................. 25 no change. 

Levophenacylmorphan .................................................................................................................................................... 25 no change. 

Lysergic acid diethylamide (LSD) .................................................................................................................................... 40 no change. 

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

carboxamide).

30 no change. 

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

dimethylbutanoate).

30 no change. 

MDMB-FUBINACA (methyl 2-(1-(4-fluorobenzyl)-1H-indazole-3-carboxamido)-3,3-dimethylbutanoate) ....................... 30 no change. 

MMB-CHMICA-(AMB-CHMICA); Methyl-2-(1-(cyclohexylmethyl)-1H-indole-3-carboxamido)-3-methylbutanoate ......... 25 no change. 

Marihuana ........................................................................................................................................................................ 1,500,000 2,000,000. 

Marihuana extract ............................................................................................................................................................ 200,000 500,000. 

Mecloqualone .................................................................................................................................................................. 30 no change. 

Mescaline ......................................................................................................................................................................... 25 no change. 

Methaqualone .................................................................................................................................................................. 60 no change. 

Methcathinone ................................................................................................................................................................. 25 no change. 

Methyoxyacetyl fentanyl .................................................................................................................................................. 30 no change. 

Methyldesorphine ............................................................................................................................................................ 5 no change. 

Methyldihydromorphine ................................................................................................................................................... 25 no change. 

Morpheridine .................................................................................................................................................................... 25 no change. 

Morphine methylbromide ................................................................................................................................................. 5 no change. 

Morphine methylsulfonate ............................................................................................................................................... 5 no change. 

Morphine-N-oxide ............................................................................................................................................................ 150 no change. 

MT-45 .............................................................................................................................................................................. 30 no change. 

Myrophine ........................................................................................................................................................................ 25 no change. 

NM2201; Naphthalen-1-yl 1-(5-fluoropentyl)-1H-indole-3-carboxylate ............................................................................ 25 no change. 

N,N-Dimethylamphetamine .............................................................................................................................................. 25 no change. 

Naphyrone ....................................................................................................................................................................... 25 no change. 

N-Ethyl-1-phenylcyclohexylamine .................................................................................................................................... 25 no change. 

N-Ethyl-3-piperidyl benzilate ............................................................................................................................................ 10 no change. 

N-Ethylamphetamine ....................................................................................................................................................... 24 no change. 

N-Ethylhexedrone ............................................................................................................................................................ 25 no change. 

N-Ethylpentylone, ephylone ............................................................................................................................................. 30 no change. 

N-Hydroxy-3,4-methylenedioxyamphetamine .................................................................................................................. 24 no change. 


lotter on DSK11XQN23PROD with NOTICES1
49352 Federal Register / Vol. 86, No. 168 / Thursday, September 2, 2021 / Notices 

Basic class 

Established 

2021 

quotas 

Proposed 

revised 

2021 

quotas 

(g) (g) 

N-Methyl-3-Piperidyl Benzilate ........................................................................................................................................ 30 no change. 

Nicocodeine ..................................................................................................................................................................... 25 no change. 

Nicomorphine ................................................................................................................................................................... 25 no change. 

Noracymethadol ............................................................................................................................................................... 25 no change. 

Norlevorphanol ................................................................................................................................................................ 2,550 no change. 

Normethadone ................................................................................................................................................................. 25 no change. 

Normorphine .................................................................................................................................................................... 40 no change. 

Norpipanone .................................................................................................................................................................... 25 no change. 

Ocfentanil ......................................................................................................................................................................... 25 no change. 

Ortho-fluorofentanyl, 2-fluorofentanyl .............................................................................................................................. 30 no change. 

ortho-Fluoroacryl fentanyl ................................................................................................................................................ N/A 30. 

ortho-Fluorobutyryl fentanyl ............................................................................................................................................. N/A 30. 

ortho-Fluoroisobutyryl fentanyl ........................................................................................................................................ N/A 30. 

ortho-Methyl acetylfentanyl .............................................................................................................................................. N/A 30. 

ortho-Methyl methoxyacetyl fentanyl ............................................................................................................................... N/A 30. 

Para-chloroisobutyryl fentanyl ......................................................................................................................................... 30 no change. 

Para-fluorofentanyl .......................................................................................................................................................... 25 no change. 

Para-fluorobutyryl fentanyl ............................................................................................................................................... 25 no change. 

para-Fluoro furanyl fentanyl ............................................................................................................................................ N/A 30. 

para-Methylfentanyl ......................................................................................................................................................... N/A 30. 

Para-methoxybutyryl fentanyl .......................................................................................................................................... 30 no change. 

Parahexyl ......................................................................................................................................................................... 5 no change. 

PB-22; QUPIC ................................................................................................................................................................. 20 no change. 

Pentedrone ...................................................................................................................................................................... 25 no change. 

Pentylone ......................................................................................................................................................................... 25 no change. 

Phenadoxone ................................................................................................................................................................... 25 no change. 

Phenampromide .............................................................................................................................................................. 25 no change. 

Phenomorphan ................................................................................................................................................................ 25 no change. 

Phenoperidine .................................................................................................................................................................. 25 no change. 

Phenyl fentanyl ................................................................................................................................................................ N/A 30. 

Pholcodine ....................................................................................................................................................................... 5 no change. 

Piritramide ........................................................................................................................................................................ 25 no change. 

Proheptazine .................................................................................................................................................................... 25 no change. 

Properidine ...................................................................................................................................................................... 25 no change. 

Propiram .......................................................................................................................................................................... 25 no change. 

Psilocybin ......................................................................................................................................................................... 30 1,500. 

Psilocyn ........................................................................................................................................................................... 50 1,000. 

Racemoramide ................................................................................................................................................................ 25 no change. 

SR-18 and RCS-8 (1-Cyclohexylethyl-3-(2-methoxyphenylacetyl)indole) ...................................................................... 45 no change. 

SR-19 and RCS-4 (1-Pentyl-3-[(4-methoxy)-benzoyl]indole) .......................................................................................... 30 no change. 

Tetrahydrofuranyl fentanyl ............................................................................................................................................... 15 no change. 

Thebacon ......................................................................................................................................................................... 25 no change. 

Thiafentanil ...................................................................................................................................................................... 25 no change. 

Thiofentanyl ..................................................................................................................................................................... 25 no change. 

Thiofuranyl fentanyl ......................................................................................................................................................... N/A 30. 

THJ-2201 ([1-(5-fluoropentyl)-1H-indazol-3-yl](naphthalen-1-yl)methanone) ................................................................. 30 no change. 

Tilidine ............................................................................................................................................................................. 25 no change. 

Trimeperidine ................................................................................................................................................................... 25 no change. 

UR-144 (1-pentyl-1H-indol-3-yl)(2,2,3,3-tetramethylcyclopropyl)methanone .................................................................. 25 no change. 

U-47700 ........................................................................................................................................................................... 30 no change. 

Valeryl fentanyl ................................................................................................................................................................ 25 no change. 

Schedule II 

1-Phenylcyclohexylamine ................................................................................................................................................ 15 no change. 

1-Piperidinocyclohexanecarbonitrile ................................................................................................................................ 25 no change. 

4-Anilino-N-phenethyl-4-piperidine (ANPP) ..................................................................................................................... 937,758 no change. 

Alfentanil .......................................................................................................................................................................... 3,260 no change. 

Alphaprodine .................................................................................................................................................................... 25 no change. 

Amobarbital ...................................................................................................................................................................... 20,100 no change. 

Bezitramide ...................................................................................................................................................................... 25 no change. 

Carfentanil ....................................................................................................................................................................... 20 no change. 

Cocaine ............................................................................................................................................................................ 68,576 no change. 

Codeine (for conversion) ................................................................................................................................................. 1,612,500 no change. 

Codeine (for sale) ............................................................................................................................................................ 27,616,684 no change. 

D-amphetamine (for sale) ................................................................................................................................................ 21,200,000 no change. 

D,l-amphetamine ............................................................................................................................................................. 21,200,000 no change. 

D-amphetamine (for conversion) ..................................................................................................................................... 14,137,578 16,068,789. 

Dextropropoxyphene ....................................................................................................................................................... 35 no change. 

Dihydrocodeine ................................................................................................................................................................ 156,713 no change. 


lotter on DSK11XQN23PROD with NOTICES1
Federal Register / Vol. 86, No. 168 / Thursday, September 2, 2021 / Notices 49353 

Basic class 

Established 

2021 

quotas 

Proposed 

revised 

2021 

quotas 

(g) (g) 

Dihydroetorphine ............................................................................................................................................................. 25 no change. 

Diphenoxylate (for conversion) ........................................................................................................................................ 14,100 no change. 

Diphenoxylate (for sale) .................................................................................................................................................. 770,800 no change. 

Ecgonine .......................................................................................................................................................................... 68,576 no change. 

Ethylmorphine .................................................................................................................................................................. 30 no change. 

Etorphine hydrochloride ................................................................................................................................................... 32 no change. 

Fentanyl ........................................................................................................................................................................... 731,452 no change. 

Glutethimide ..................................................................................................................................................................... 25 no change. 

Hydrocodone (for conversion) ......................................................................................................................................... 1,250 no change. 

Hydrocodone (for sale) .................................................................................................................................................... 30,821,224 no change. 

Hydromorphone ............................................................................................................................................................... 2,827,940 2,743,101. 

Isomethadone .................................................................................................................................................................. 30 no change. 

L-amphetamine ................................................................................................................................................................ 30 no change. 

Levo-alphacetylmethadol (LAAM) ................................................................................................................................... 25 no change. 

Levomethorphan .............................................................................................................................................................. 30 no change. 

Levorphanol ..................................................................................................................................................................... 26,495 no change. 

Lisdexamfetamine ............................................................................................................................................................ 21,000,000 no change. 

L-methamphetamine ........................................................................................................................................................ 587,229 no change. 

Meperidine ....................................................................................................................................................................... 856,695 no change. 

Meperidine Intermediate-A .............................................................................................................................................. 30 no change. 

Meperidine Intermediate-B .............................................................................................................................................. 30 no change. 

Meperidine Intermediate-C .............................................................................................................................................. 30 no change. 

Metazocine ...................................................................................................................................................................... 15 no change. 

Methadone (for sale) ....................................................................................................................................................... 25,619,700 no change. 

Methadone Intermediate .................................................................................................................................................. 27,673,600 no change. 

Methamphetamine ........................................................................................................................................................... 50 no change. 

D-methamphetamine (for conversion) ............................................................................................................................. 485,020 no change. 

D-methamphetamine (for sale) ........................................................................................................................................ 40,000 no change. 

Methylphenidate (for conversion) .................................................................................................................................... 0 15,300,000. 

Methylphenidate (for sale) ............................................................................................................................................... 57,438,334 no change. 

Metopon ........................................................................................................................................................................... 25 no change. 

Moramide-intermediate .................................................................................................................................................... 25 no change. 

Morphine (for conversion) ............................................................................................................................................... 3,376,696 no change. 

Morphine (for sale) .......................................................................................................................................................... 27,784,062 26,505,995. 

Nabilone ........................................................................................................................................................................... 62,000 no change. 

Norfentanyl ...................................................................................................................................................................... 25 no change. 

Noroxymorphone (for conversion) ................................................................................................................................... 22,044,741 no change. 

Noroxymorphone (for sale) .............................................................................................................................................. 376,000 no change. 

Oliceridine ........................................................................................................................................................................ N/A 22,500. 

Opium (powder) ............................................................................................................................................................... 250,000 no change. 

Opium (tincture) ............................................................................................................................................................... 530,837 no change. 

Oripavine ......................................................................................................................................................................... 33,010,750 no change. 

Oxycodone (for conversion) ............................................................................................................................................ 620,887 no change. 

Oxycodone (for sale) ....................................................................................................................................................... 57,110,032 no change. 

Oxymorphone (for conversion) ........................................................................................................................................ 28,204,371 no change. 

Oxymorphone (for sale) ................................................................................................................................................... 563,174 no change. 

Pentobarbital .................................................................................................................................................................... 25,850,000 30,766,670. 

Phenazocine .................................................................................................................................................................... 25 no change. 

Phencyclidine ................................................................................................................................................................... 35 no change. 

Phenmetrazine ................................................................................................................................................................. 25 no change. 

Phenylacetone ................................................................................................................................................................. 40 no change. 

Piminodine ....................................................................................................................................................................... 25 no change. 

Racemethorphan ............................................................................................................................................................. 5 no change. 

Racemorphan .................................................................................................................................................................. 5 no change. 

Remifentanil ..................................................................................................................................................................... 3,000 no change. 

Secobarbital ..................................................................................................................................................................... 172,100 no change. 

Sufentanil ......................................................................................................................................................................... 4,000 no change. 

Tapentadol ....................................................................................................................................................................... 13,447,541 no change. 

Thebaine .......................................................................................................................................................................... 57,137,944 no change. 

List I Chemicals 

Ephedrine (for conversion) .............................................................................................................................................. 100 no change. 

Ephedrine (for sale) ......................................................................................................................................................... 4,136,000 no change. 

Phenylpropanolamine (for conversion) ............................................................................................................................ 14,878,320 no change. 

Phenylpropanolamine (for sale) ...................................................................................................................................... 16,690,000 no change. 

Pseudoephedrine (for conversion) .................................................................................................................................. 1,000 no change. 

Pseudoephedrine (for sale) ............................................................................................................................................. 174,246,000 no change. 


lotter on DSK11XQN23PROD with NOTICES1
49354 Federal Register / Vol. 86, No. 168 / Thursday, September 2, 2021 / Notices 

1See 42 U.S.C. 2000e–8(c); 29 CFR 1602.7; 41 

CFR 60–1.7. 

2See 79 FR 46561 (Aug. 8, 2014). 

3See 81 FR 45479 (July 14, 2016). 

4See 82 FR 43362 (Sept. 15, 2017). 

5National Women’s Law Center, et al. v. Office 

of Management and Budget, et al., 358 F. Supp. 3d 

66 (D.D.C. 2019). 

The Administrator further proposes 

that aggregate production quotas for all 

other schedule I and II controlled 

substances included in 21 CFR 1308.11 

and 1308.12 remain at zero. In 

accordance with 21 CFR 1303.13 and 21 

CFR 1315.13, upon consideration of the 

relevant factors, the Administrator may 

adjust the 2021 aggregate production 

quotas and assessment of annual needs 

as needed. 

Conclusion 

After consideration of any comments 

or objections, or after a hearing, if one 

is held, the Administrator will issue and 

publish in the Federal Register a final 

order establishing any adjustment of 

2021 aggregate production quota for 

each basic class of controlled substances 

in schedules I and II and the assessment 

of annual needs for the list I chemicals 

ephedrine, pseudoephedrine, and 

phenylpropanolamine. 21 CFR 

1303.13(c) and 1315.13(f). 

Anne Milgram, 

Administrator. 

[FR Doc. 2021–18935 Filed 9–1–21; 8:45 am] 

BILLING CODE 4410–09–P 

DEPARTMENT OF LABOR 

Office of Federal Contract Compliance 

Programs 

Rescission of Notice of Intention Not 

To Request, Accept or Use Employer 

Information Report (EEO–1) 

Component 2 Data, November 25, 2019 

AGENCY: Office of Federal Contract 

Compliance Programs, Labor. 

ACTION: Notice. 

SUMMARY: The U.S. Department of 

Labor’s Office of Federal Contract 

Compliance Programs (OFCCP) and the 

Equal Employment Opportunity 

Commission (EEOC) collect workforce 

data through the Employer Information 

Report (EEO–1) under their Joint 

Reporting Committee. OFCCP is 

rescinding its previously issued notice, 

which stated that OFCCP did not intend 

to request, accept, or use EEO–1 

Component 2 data. The agency has 

determined that it was premature to 

issue a notice stating OFCCP did not 

expect to find significant utility in the 

data. 

DATES: This action is effective 

immediately. 

FOR FURTHER INFORMATION CONTACT: Tina 

T. Williams, Director, Division of Policy 

and Program Development, Office of 

Federal Contract Compliance Programs, 

200 Constitution Avenue NW, Room C– 

3325, Washington, DC 20210. 

Telephone: (202) 693–0103 (voice) or 

(202) 693–1337 (TTY). 

SUPPLEMENTARY INFORMATION: 

Background 

OFCCP administers and enforces 

Executive Order 11246, as amended 

(E.O. 11246), which applies to Federal 

contractors and subcontractors. E.O. 

11246 prohibits employment 

discrimination and requires affirmative 

action to ensure equal employment 

opportunity regardless of race, color, 

religion, sex, sexual orientation, gender 

identity, or national origin. It also 

prohibits Federal contractors and 

subcontractors from discriminating 

against applicants and employees for 

inquiring about, discussing, or 

disclosing information about their pay 

or the pay of their co-workers, subject to 

certain limitations. 

OFCCP and the EEOC have separate 

legal authority to collect EEO–1 data, 

and they coordinate collection to 

promote efficiency through their Joint 

Reporting Committee. The EEOC’s legal 

authority to collect EEO–1 data from 

private employers derives from Title VII 

of the Civil Rights Act, and OFCCP’s 

authority to collect data from certain 

Federal contractors derives from E.O. 

11246 and its implementing 

regulations.1 The EEO–1 data collection 

is a mandatory annual data collection 

that requires all private sector 

employers that are covered by Title VII 

and have 100 or more employees, and 

Federal contractors with 50 or more 

employees meeting certain criteria, to 

submit demographic workforce data, 

including data by sex, race, ethnicity, 

and job categories (Component 1) 

(Office of Management and Budget 

(OMB) Control No. 3046–0049). The 

EEO–1 Component 1 data has been 

shared between the two agencies for 

decades to avoid duplicative 

information collections and to minimize 

the burden on employers. 

OFCCP had previously expressed 

interest in collecting summary 

compensation data for the purpose of 

informing its compliance and 

enforcement efforts. On August 8, 2014, 

OFCCP published a notice of proposed 

rulemaking in the Federal Register to 

amend the regulations that implement 

E.O. 11246 by adding a requirement that 

certain Federal contractors and 

subcontractors supplement their EEO–1 

Report with summary information on 

compensation paid to employees, as 

contained in the Form W–2, Wage and 

Tax Statement, by sex, race, ethnicity, 

and specified job categories, as well as 

other relevant data points such as hours 

worked and the number of employees.2

The purpose of the proposed collection 

was to enable OFCCP to more effectively 

focus its enforcement resources to better 

identify potential pay inequities for 

further evaluations. Public comments 

submitted to OFCCP on the proposal 

argued for, among other things, 

improving interagency coordination and 

decreasing employer burden for 

reporting compensation data by using 

the EEO–1 data collection, rather than 

conducting a new OFCCP data 

collection. Ultimately, OFCCP 

determined that it would collaborate 

with the EEOC to collect compensation 

data as part of the EEO–1 filing rather 

than proceed with publishing a final 

rule. 

On July 14, 2016, the EEOC published 

a 30-day notice in the Federal Register 

to obtain a three-year approval from 

OMB for the continued collection of 

Component 1 demographic data, as well 

as a new collection of summary 

compensation data, referred to as 

‘‘Component 2’’ EEO–1 data.3 The 

notice stated that, although the EEOC is 

responsible for compliance with the 

Paperwork Reduction Act of 1995, the 

EEO–1 report is a joint data collection 

to meet the enforcement needs of both 

the EEOC and OFCCP while avoiding 

duplication. The Component 2 

collection included aggregated data on 

employee pay and hours worked. On 

September 29, 2016, OMB approved the 

EEO–1 Components 1 and 2 information 

collection for calendar years 2017 and 

2018. 

On August 29, 2017, OMB stayed the 

EEOC’s collection of Component 2 data, 

and the EEOC proceeded to collect only 

Component 1 data. Subsequently, the 

EEOC issued a Federal Register notice 

on September 15, 2017, suspending the 

Component 2 data collection.4 In 

response to a lawsuit challenging OMB 

and the EEOC’s actions, on March 4, 

2019, the United States District Court 

for the District of Columbia vacated 

OMB’s stay of the Component 2 data 

collection and ordered that the previous 

approval of the EEO–1 Component 2 

collection was in effect.5 The court 

further ordered the EEOC to collect the 

Component 2 data for calendar years 

2017 and 2018 by September 30, 2019. 

On May 3, 2019, the EEOC published a 

Federal Register notice announcing the 


lotter on DSK11XQN23PROD with NOTICES1