Federal Register / Vol. 86, No. 168 / Thursday, September 2, 2021 / Proposed Rules 49267 

1The parenthetical reference provides a reference 

for information located in DOE’s rulemaking 

docket. (Docket No. EERE–2021–BT–STD–0018, 

which is maintained at www.regulations.gov/ 

#!docketDetail;D=EERE-2021-BT-STD-0018). The 

references are arranged as follows: (commenter 

name, comment docket ID number, page of that 

document). 

Docket: The docket for this activity, 

which includes Federal Register 

notices, comments, and other 

supporting documents/materials, is 

available for review at 

www.regulations.gov. All documents in 

the docket are listed in the 

www.regulations.gov index. However, 

some documents listed in the index, 

such as those containing information 

that is exempt from public disclosure, 

may not be publicly available. 

The docket web page can be found at: 

www.regulations.gov/docket/EERE2021-BT-STD-0018. The docket web 

page contains instructions on how to 

access all documents, including public 

comments, in the docket. 

FOR FURTHER INFORMATION CONTACT: Mr. 

Jeremy Dommu, U.S. Department of 

Energy, Office of Energy Efficiency and 

Renewable Energy, Building 

Technologies Office, EE–2J, 1000 

Independence Avenue SW, Washington, 

DC 20585–0121. Telephone: (202) 586– 

9870. Email: 

ApplianceStandardsQuestions@

ee.doe.gov. 

Ms. Amelia Whiting, U.S. Department 

of Energy, Office of the General Counsel, 

GC–33, 1000 Independence Avenue SW, 

Washington, DC 20585–0121. 

Telephone: (202) 586–2588. Email: 

Amelia.Whiting@hq.doe.gov. 

For further information on how to 

submit a comment or review other 

public comments and the docket contact 

the Appliance and Equipment 

Standards Program staff at (202) 287– 

1445 or by email: 

ApplianceStandardsQuestions@

ee.doe.gov. 

SUPPLEMENTARY INFORMATION: On August 

9, 2021, DOE published a RFI 

undertaking an early assessment review 

for amended energy conservation 

standards for pumps to determine 

whether to amend applicable energy 

conservation standards. Specifically, 

DOE is seeking data and information to 

evaluate whether amended energy 

conservation standards would result in 

a significant savings of energy; be 

technologically feasible; and be 

economically justified. 86 FR 43430. 

Interested parties in the matter, 

Grundfos (on August 10, 2021), HI (on 

August 12, 2021), Pentair (on August 12, 

2021), and CA IOUs (on August 13, 

2021), requested an extension of the 

public comment period for the RFI. 

(Grundfos, No. 2 at p. 1; HI, No. 3 at p. 

1; Pentair., No. 4 at p. 1; CA IOUs, No. 

5, at p. 1).1 Grundos, HI, and Pentair 

commented that the extension is 

necessary to allow ample time to 

provide adequate comments on the 

issues identified. (Grundfos, No. 2 at p. 

1; HI, No. 3 at p. 1; Pentair., No. 4 at 

p. 1) The CA IOUs noted that a data set 

of pump performance data was being 

complied by the Northwest Energy 

Efficiency Alliance (‘‘NEEA’’) and 

additional time was necessary to 

analyze and review the NEEA dataset. 

(CA IOUs, No. 5, at p. 1) 

DOE has reviewed the requests and is 

extending the comment period to allow 

additional time for interested parties to 

submit comments. As noted, the RFI 

was issued as part of an early 

assessment review to determine whether 

to amend energy conservation standards 

for pumps. Based on the information 

received in response to this RFI, DOE 

will determine whether to proceed with 

a rulemaking for a new or amended 

energy conservation standard. If DOE 

makes an initial determination that a 

new or amended energy conservation 

standard would satisfy the applicable 

statutory criteria or DOE’s analysis is 

inconclusive, DOE would undertake the 

preliminary stages of a rulemaking to 

issue a new or amended energy 

conservation standard. If DOE makes an 

initial determination based upon 

available evidence that a new or 

amended energy conservation standard 

would not meet the applicable statutory 

criteria, DOE will engage in notice and 

comment rulemaking before issuing a 

final determination that new or 

amended energy conservation standards 

are not warranted. As such, DOE has 

determined that an extension of 30 days 

is sufficient for this preliminary stage. 

Therefore, DOE is extending the 

comment period until October 8, 2021. 

Signing Authority 

This document of the Department of 

Energy was signed on August 27, 2021, 

by Kelly Speakes-Backman, Principal 

Deputy Assistant Secretary and Acting 

Assistant Secretary for Energy Efficiency 

and Renewable Energy, pursuant to 

delegated authority from the Secretary 

of Energy. That document with the 

original signature and date is 

maintained by DOE. For administrative 

purposes only, and in compliance with 

requirements of the Office of the Federal 

Register, the undersigned DOE Federal 

Register Liaison Officer has been 

authorized to sign and submit the 

document in electronic format for 

publication, as an official document of 

the Department of Energy. This 

administrative process in no way alters 

the legal effect of this document upon 

publication in the Federal Register. 

Signed in Washington, DC, on August 27, 

2021. 

Treena V. Garrett, 

Federal Register Liaison Officer, U.S. 

Department of Energy. 

[FR Doc. 2021–18885 Filed 9–1–21; 8:45 am] 

BILLING CODE 6450–01–P 

DEPARTMENT OF JUSTICE 

Drug Enforcement Administration 

21 CFR Part 1308 

[Docket No. DEA–737] 

Schedules of Controlled Substances: 

Placement of Methiopropamine in 

Schedule I 

AGENCY: Drug Enforcement 

Administration, Department of Justice. 

ACTION: Notice of proposed rulemaking. 

SUMMARY: The Drug Enforcement 

Administration proposes placing Nmethyl-1-(thiophen-2-yl)propan-2- 

amine (methiopropamine), including its 

salts, isomers, and salts of isomers, in 

schedule I of the Controlled Substances 

Act. This action is being taken to enable 

the United States to meet its obligations 

under the 1971 Convention on 

Psychotropic Substances. If finalized, 

this action would impose the regulatory 

controls and administrative, civil, and 

criminal sanctions applicable to 

schedule I controlled substances on 

persons who handle (manufacture, 

distribute, reverse distribute, import, 

export, engage in research, conduct 

instructional activities or chemical 

analysis, or possess) or propose to 

handle methiopropamine. 

DATES: Comments must be submitted 

electronically or postmarked on or 

before October 4, 2021. 

Interested persons may file written 

comments on this proposal in 

accordance with 21 CFR 1308.43(g). 

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. 

Interested persons may file a request 

for a hearing or waiver of hearing 

pursuant to 21 CFR 1308.44 and in 

accordance with 21 CFR 1316.45 and/or 

1316.47, as applicable. Requests for a 

hearing and waivers of an opportunity 

for a hearing or to participate in a 

hearing, together with a written 

statement of position on the matters of 


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49268 Federal Register / Vol. 86, No. 168 / Thursday, September 2, 2021 / Proposed Rules 

1As discussed in a memorandum of 

understanding entered into by the Food and Drug 

Administration (FDA) and the National Institute on 

Drug Abuse (NIDA), FDA acts as the lead agency 

within HHS in carrying out the Secretary’s 

scheduling responsibilities under the Controlled 

Substances Act, with the concurrence of NIDA. 50 

FR 9518 (March 8, 1985). The Secretary of HHS has 

delegated to the Assistant Secretary for Health of 

HHS the authority to make domestic drug 

scheduling recommendations. 58 FR 35460 (July 1, 

1993). 

fact and law asserted in the hearing, 

must be received on or before October 

4, 2021. 

ADDRESSES: To ensure proper handling 

of comments, please reference ‘‘Docket 

No. DEA–737’’ on all electronic and 

written correspondence, including any 

attachments. 

• Electronic comments: The Drug 

Enforcement Administration (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: Paper comments 

that duplicate the electronic submission 

are not necessary. 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, Attn: DEA 

Federal Register Representative/DPW, 

8701 Morrissette Drive, Springfield, 

Virginia 22152. 

• Hearing requests: All requests for a 

hearing and waivers of participation, 

together with a written statement of 

position on the matters of fact and law 

asserted in the hearing, must be sent to: 

Drug Enforcement Administration, Attn: 

Administrator, 8701 Morrissette Drive, 

Springfield, Virginia 22152. All requests 

for hearing and waivers of participation 

should also be sent to: (1) Drug 

Enforcement Administration, Attn: 

Hearing Clerk/OALJ, 8701 Morrissette 

Drive, Springfield, Virginia 22152; and 

(2) Drug Enforcement Administration, 

Attn: DEA Federal Register 

Representative/DPW, 8701 Morrissette 

Drive, Springfield, Virginia 22152. 

FOR FURTHER INFORMATION CONTACT: Dr. 

Terrence L. Boos, Drug and Chemical 

Evaluation Section, Diversion Control 

Division, Drug Enforcement 

Administration; Telephone: (571) 362– 

3249. 

SUPPLEMENTARY INFORMATION: 

Posting of Public Comments 

Please note that all comments 

received in response to this docket are 

considered part of the public record. 

The Drug Enforcement Administration 

(DEA) will make them available, unless 

reasonable cause is given, 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 of the personal identifying 

information you do not want made 

publicly available in the first paragraph 

of your comment and identify what 

information you want redacted. 

If you want to submit confidential 

business information as part of your 

comment, but do not want it to be made 

publicly available, you must include the 

phrase ‘‘CONFIDENTIAL BUSINESS 

INFORMATION’’ in the first paragraph 

of your comment. You must also 

prominently identify the confidential 

business information to be redacted 

within the comment. 

DEA will make available publicly in 

redacted form comments containing 

personal identifying information or 

confidential business information 

identified as directed above. If a 

comment has so much confidential 

business information that it cannot be 

redacted effectively, all or part of that 

comment may not be made available 

publicly. 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 as 

directed above. 

An electronic copy of this document 

and supplemental information to this 

proposed rule are available at http://

www.regulations.gov for easy reference. 

Request for Hearing or Appearance; 

Waiver 

Pursuant to 21 U.S.C. 811(a), this 

action is a formal rulemaking ‘‘on the 

record after opportunity for a hearing.’’ 

Such proceedings are conducted 

pursuant to the provisions of the 

Administrative Procedure Act, 5 U.S.C. 

551–559. 21 CFR 1308.41–1308.45; 21 

CFR part 1316, subpart D. Interested 

persons may file requests for hearing or 

notices of intent to participate in a 

hearing in conformity with the 

requirements of 21 CFR 1308.44(a) or 

(b), and include a statement of interest 

in the proceeding and the objections or 

issues, if any, concerning which the 

person desires to be heard. 21 CFR 

1316.47(a). Any interested person may 

file a waiver of an opportunity for a 

hearing or to participate in a hearing 

together with a written statement 

regarding the interested person’s 

position on the matters of fact and law 

involved in any hearing as set forth in 

21 CFR 1308.44(c). 

All requests for a hearing and waivers 

of participation, together with a written 

statement of position on the matters of 

fact and law asserted in the hearing, 

must be sent to DEA using the address 

information provided above. 

Legal Authority 

The United States is a party to the 

1971 United Nations Convention on 

Psychotropic Substances (1971 

Convention), February 21, 1971, 32 

U.S.T. 543, 1019 U.N.T.S. 175, as 

amended. Procedures respecting 

changes in drug schedules under the 

1971 Convention are governed 

domestically by 21 U.S.C. 811(d)(2–4). 

When the United States receives 

notification of a scheduling decision 

pursuant to Article 2 of the 1971 

Convention adding a drug or other 

substance to a specific schedule, the 

Secretary of the Department of Health 

and Human Services (HHS),1 after 

consultation with the Attorney General, 

shall first determine whether existing 

legal controls under subchapter I of the 

Controlled Substances Act (CSA) and 

the Federal Food, Drug, and Cosmetic 

Act meet the requirements of the 

schedule specified in the notification 

with respect to the specific drug or 

substance. 21 U.S.C. 811(d)(3). In the 

event that the Secretary of HHS 

(Secretary) did not consult with the 

Attorney General, and the Attorney 

General did not issue a temporary order, 

as provided under 21 U.S.C. 811(d)(4), 

the procedures for permanent 

scheduling set forth in 21 U.S.C. 811(a) 

and (b) control. Pursuant to 21 U.S.C. 

811(a)(1), the Attorney General, by rule, 

may add to such a schedule any drug or 

other substance, if he finds that such 

drug or other substance has a potential 


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Federal Register / Vol. 86, No. 168 / Thursday, September 2, 2021 / Proposed Rules 49269 

2Comprehensive Drug Abuse Prevention and 

Control Act of 1970, H.R. Rep. No. 91–1444, 91st 

Cong., Sess. 1 (1970); reprinted in 1970 

U.S.C.C.A.N. 4566, 4603. 

for abuse, and makes with respect to 

such drug or other substance the 

findings prescribed by 21 U.S.C. 812(b) 

for the schedule in which such drug is 

to be placed. The Attorney General has 

delegated this scheduling authority to 

the Administrator of DEA. 28 CFR 

0.100. 

Background 

Methiopropamine is a central nervous 

stimulant and is structurally related to 

the schedule II stimulants 

methamphetamine and amphetamine. 

On April 21, 2017, the SecretaryGeneral of the United Nations advised 

the Secretary of State of the United 

States that during its 60th session, on 

March 16, 2017, the Commission on 

Narcotic Drugs voted to place N-methyl1-(thiophen-2-yl)propan-2-amine 

(methiopropamine) in Schedule II of the 

1971 Convention (CND Dec/60/8). 

Because the procedures in 21 U.S.C. 

811(d)(3) and (4) for consultation and 

issuance of a temporary order for 

methiopropamine, discussed in the 

above legal authority section, were not 

followed, DEA is utilizing the 

procedures for permanent scheduling 

set forth in 21 U.S.C. 811(a) and (b) to 

control methiopropamine. Such 

scheduling would satisfy the United 

States’ international obligations. 

Article 2, paragraph 7(b), of the 1971 

Convention sets forth the minimum 

requirements that the United States 

must meet when a substance has been 

added to Schedule II of the 1971 

Convention. Pursuant to the 1971 

Convention, the United States must 

require licenses for the manufacture, 

export and import, and distribution of 

methiopropamine. This license 

requirement is accomplished by the 

CSA’s registration requirement as set 

forth in 21 U.S.C. 822, 823, 957, 958 and 

in accordance with 21 CFR parts 1301 

and 1312. In addition, the United States 

must adhere to specific export and 

import provisions set forth in the 1971 

Convention. This requirement is 

accomplished by the CSA’s export and 

import provisions established in 21 

U.S.C. 952, 953, 957, 958 and in 

accordance with 21 CFR part 1312. 

Likewise, under Article 13, paragraphs 

1 and 2, of the 1971 Convention, a party 

to the 1971 Convention may notify 

through the UN Secretary-General 

another party that it prohibits the 

importation of a substance in Schedule 

II, III, or IV of the 1971 Convention. If 

such notice is presented to the United 

States, the United States shall take 

measures to ensure that the named 

substance is not exported to the 

notifying country. This requirement is 

also accomplished by the CSA’s export 

provisions mentioned above. Under 

Article 16, paragraph 4, of the 1971 

Convention, the United States is 

required to provide annual statistical 

reports to the International Narcotics 

Control Board (INCB). Using INCB Form 

P, the United States shall provide the 

following information: (1) In regard to 

each substance in Schedule I and II of 

the 1971 Convention, quantities 

manufactured in, exported to, and 

imported from each country or region as 

well as stocks held by manufacturers; 

(2) in regard to each substance in 

Schedule II and III of the 1971 

Convention, quantities used in the 

manufacture of exempt preparations; 

and (3) in regard to each substance in 

Schedule II–IV of the 1971 Convention, 

quantities used for the manufacture of 

non-psychotropic substances or 

products. Lastly, under Article 2 of the 

1971 Convention, the United States 

must adopt measures in accordance 

with Article 22 to address violations of 

any statutes or regulations that are 

adopted pursuant to its obligations 

under the 1971 Convention. Persons 

acting outside the legal framework 

established by the CSA are subject to 

administrative, civil, and/or criminal 

action; therefore, the United States 

complies with this provision. 

DEA notes that there are differences 

between the schedules of substances in 

the 1971 Convention and the CSA. The 

CSA has five schedules (schedules I–V) 

with specific criteria set forth for each 

schedule. Schedule I is the only 

possible schedule in which a drug or 

other substance may be placed if it has 

high potential for abuse and no 

currently accepted medical use in 

treatment in the United States. See 21 

U.S.C. 812(b). In contrast, the 1971 

Convention has four schedules 

(Schedules I–IV) but does not have 

specific criteria for each schedule. The 

1971 Convention simply defines its four 

schedules, in Article 1, to mean the 

correspondingly numbered lists of 

psychotropic substances annexed to the 

Convention, and altered in accordance 

with Article 2. 

Proposed Determination To Schedule 

Methiopropamine 

On November 20, 2018, DEA 

requested HHS conduct a scientific and 

medical evaluation and recommend 

whether methiopropamine should be 

controlled under the CSA. On August 

27, 2020 (dated August 25, 2020), HHS 

provided DEA a scientific and medical 

evaluation entitled ‘‘Basis for the 

recommendation to control 

methiopropamine and its salts in 

schedule I of the Controlled Substance 

Act’’ and a scheduling recommendation. 

Pursuant to 21 U.S.C. 811(b), following 

consideration of the eight-factors and 

findings related to the substance’s abuse 

potential, legitimate medical use, safety, 

and dependence liability, HHS 

recommended that methiopropamine be 

controlled in schedule I of the CSA 

under 21 U.S.C. 812(b). Upon receipt of 

the scientific and medical evaluation 

and scheduling recommendation from 

HHS, DEA reviewed the documents and 

all other relevant data and conducted its 

own eight-factor analysis in accordance 

with 21 U.S.C. 811(c). Included below is 

a brief summary of each factor as 

analyzed by HHS and DEA, and as 

considered by DEA in its proposed 

scheduling action. Please note that both 

DEA and HHS eight-factor analyses are 

available in their entirety under the tab 

‘‘Supporting Documents’’ of the public 

docket of this rulemaking action at 

http://www.regulations.gov, under 

docket number ‘‘DEA–737.’’ 

1. The Drug’s Actual or Relative 

Potential for Abuse: The term ‘‘abuse’’ is 

not defined in the CSA. However, the 

legislative history of the CSA suggests 

that DEA consider the following criteria 

when determining whether a particular 

drug or substance has a potential for 

abuse: 2

(a) There is evidence that individuals are 

taking the drug or drugs containing such a 

substance in amounts sufficient to create a 

hazard to their health or to the safety of other 

individuals or to the community; or 

(b) There is significant diversion of the 

drug or drugs containing such a substance 

from legitimate drug channels; or 

(c) Individuals are taking the drug or drugs 

containing such a substance on their own 

initiative rather than on the basis of medical 

advice from a practitioner licensed by law to 

administer such drugs in the course of his 

professional practice; or 

(d) The drug or drugs containing such a 

substance are new drugs so related in their 

action to a drug or drugs already listed as 

having a potential for abuse to make it likely 

that the drug will have the same potentiality 

for abuse as such drugs, thus making it 

reasonable to assume that there may be 

significant diversions from legitimate 

channels, significant use contrary to or 

without medical advice, or that it has a 

substantial capability of creating hazards to 

the health of the user or to the safety of the 

community. 

Both DEA and HHS eight-factor 

analyses found that methiopropamine 

has abuse potential associated with its 

abilities to produce psychoactive effects 

that are similar to those produced by 

schedule II stimulants such as 

amphetamine and methamphetamine 


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49270 Federal Register / Vol. 86, No. 168 / Thursday, September 2, 2021 / Proposed Rules 

3NFLIS represents an important resource in 

monitoring illicit drug trafficking, including the 

diversion of legally manufactured pharmaceuticals 

into illegal markets. NFLIS is a comprehensive 

information system that includes data from forensic 

laboratories that handle more than 96% of an 

estimated 1.0 million distinct annual State and 

local drug analysis cases. NFLIS includes drug 

chemistry results from completed analyses only. 

While NFLIS data is not direct evidence of abuse, 

it can lead to an inference that a drug has been 

diverted and abused. See 76 FR 77330, 77332, Dec. 

12, 2011. 

that have a high potential for abuse. In 

particular, the responses in humans to 

methiopropamine are stimulant-like and 

include tachycardia, anxiety, insomnia, 

perspiration, and hallucination. 

Methiopropamine has no approved 

medical uses in the United States. 

Because this substance is not an 

approved drug product, a practitioner 

may not legally prescribe it, and it 

cannot be dispensed to an individual. 

The use of this substance without 

medical advice leads to the conclusion 

that this stimulant is being abused for 

its psychoactive properties. 

Reports from public health and law 

enforcement suggest that this substance 

is being abused and taken in amounts 

sufficient to create a hazard to an 

individual’s health. This hazard is 

evidenced by deaths, representing a 

safety issue for those in the community. 

Further, methiopropamine was first 

identified in the National Forensic 

Laboratory Information System 

(NFLIS) 3 database in 2011; a September 

29, 2020 query of this database for 

methiopropamine reports indicated a 

total of 128 such reports through 2018 

from 19 states by participating federal, 

state, and local forensic laboratories. 

Consequently, the data indicate that 

methiopropamine is being abused, and 

it presents safety hazards to the health 

of individuals who consume it due to its 

stimulant properties, making it a hazard 

to the safety of the community. 

2. Scientific Evidence of the Drug’s 

Pharmacological Effects, if Known: As 

described by HHS, studies show that 

methiopropamine produces 

pharmacological effects that are similar 

to those produced by schedule II 

substances such as amphetamine and 

methamphetamine. Similar to these 

schedule II substances, 

methiopropamine binds to monoamine 

transporters for dopamine and 

norepinephrine and blocks the uptake of 

these neurotransmitters at their 

transporters. However, 

methiopropamine does not have an 

affinity for serotonin transporters or a 

significant effect on serotonin 

transporter activity. Behavioral studies 

in animals demonstrate that 

methiopropamine produces locomotor 

behavior similar to those of 

amphetamine and methamphetamine. 

Self-reports by methiopropamine users 

demonstrate that methiopropamine 

produces classic stimulant-like effects, 

including euphoria, psychological and 

psychomotor stimulation, insomnia, 

anxiety, panic attacks, and an increased 

heart rate. Overall, these data indicate 

that methiopropamine produces 

pharmacological effects and stimulantlike behaviors that are similar to those 

of schedule II substances amphetamine 

and methamphetamine. 

3. The State of Current Scientific 

Knowledge Regarding the Drug or Other 

Substance: Methiopropamine is 

structurally similar to the schedule II 

substances methamphetamine and 

amphetamine. Specifically, 

methiopropamine is a thiophene analog 

of methamphetamine. 

Self-reports by methiopropamine 

users in 2020 suggest that the 

pharmacokinetics of the drug following 

insufflation are rapid, with the onset of 

effects occurring five to ten minutes 

after administration. Methiopropamine 

reaches its maximum concentration at 

approximately thirty to sixty minutes 

later, with a duration of action that can 

persist for two to four hours. Limited 

studies identify nor-methiopropamine 

as the main metabolite found in bodily 

fluids. 

Neither DEA nor HHS is aware of any 

currently accepted medical use for 

methiopropamine. According to HHS’s 

August 2020 scientific and medical 

evaluation and scheduling 

recommendation, the Food and Drug 

Administration (FDA) has not approved 

a marketing application for a drug 

product containing methiopropamine 

for any therapeutic indication, nor is 

HHS aware of any reports of clinical 

studies or claims of an accepted medical 

use for methiopropamine in the United 

States. 

Although no evidence suggests that 

methiopropamine has a currently 

accepted medical use in treatment in the 

United States, it bears noting that a drug 

cannot be found to have such medical 

use unless DEA concludes that it 

satisfies a five-part test. Specifically, 

with respect to a drug that has not been 

approved by FDA, all of the following 

must be demonstrated: The drug’s 

chemistry is known and reproducible; 

there are adequate safety studies; there 

are adequate and well-controlled studies 

proving efficacy; the drug is accepted by 

qualified experts; and the scientific 

evidence is widely available. 57 FR 

10499 (1992), pet. for rev. denied, 

Alliance for Cannabis Therapeutics v. 

DEA, 15 F.3d 1131, 1135 (D.C. Cir. 

1994). Based on this analysis, 

methiopropamine has no currently 

accepted medical use in the United 

States. Furthermore, DEA has not found 

any references regarding clinical testing 

of methiopropamine in the scientific 

and medical literature. Taken together 

with HHS’s conclusion, DEA finds that 

there is no legitimate medical use for 

methiopropamine in the United States. 

4. History and Current Pattern of 

Abuse: As described by DEA and HHS, 

methiopropamine is a stimulant and is 

structurally and pharmacologically 

similar to the schedule II substances 

methamphetamine and amphetamine. 

Methiopropamine has been trafficked 

and abused in North America and 

Europe since its first report of abuse in 

2011. In addition, methiopropamine has 

been identified in law enforcement 

seizures in the United States since 2011 

through 2018. Thus, methiopropamine 

abuse occurs worldwide. 

5. Scope, Duration and Significance 

of Abuse: Forensic laboratories have 

confirmed the presence of 

methiopropamine in drug exhibits 

received from state, local, and federal 

law enforcement agencies. Law 

enforcement data show that 

methiopropamine first appeared in the 

illicit drug market in 2011 with four 

encounters. Overall, from 2011 through 

2018, NFLIS registered 128 reports from 

federal, state and local forensic 

laboratories identifying this substance 

in drug-related exhibits from 19 states. 

Thus, methiopropamine abuse is widespread. 

6. What, if Any, Risk There Is to the 

Public Health: Based on the review of 

both HHS and DEA, public health risks 

of methiopropamine result from its 

ability to induce stimulant-like 

responses, which may lead to adverse 

events that include psychological and 

cognitive impairment. In addition, 

methiopropamine has been involved, 

with one or more other substances, in 14 

deaths in the United Kingdom from 

2012 to 2016, with methiopropamine 

being the sole contributing substance in 

one death in Australia in 2015. Thus, 

the public health risks associated with 

methiopropamine are confirmed by the 

pharmacological profile along with the 

fatalities associated with 

methiopropamine. 

7. Its Psychic or Physiological 

Dependence Liability: According to 

HHS, the psychic or physiological 

dependence liability of 

methiopropamine is demonstrated by its 

positive abuse-related studies in 

animals and reported stimulant effects 

in humans. The results from two 

behavioral locomotor studies in 2016 

demonstrate that methiopropamine 

produced behavioral effects similar to 


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those of substances with stimulant 

effects such as amphetamine and 

methamphetamine. Furthermore, 

according to self-reports of drug users in 

2020, methiopropamine has been 

abused for its stimulant properties. In 

addition, DEA notes that because 

methiopropamine shares 

pharmacological properties with 

schedule II stimulant substances such as 

amphetamine and methamphetamine, 

methiopropamine likely has a 

dependence profile similar to these 

substances, which are known to cause 

substance dependence. 

In summary, data suggests that 

methiopropamine produces behavioral 

effects in animals and humans similar to 

those of schedule II stimulants. 

Although there are no clinical studies 

evaluating dependence liabilities 

specific for methiopropamine, the 

pharmacological profile of this 

substance suggests that it possesses 

dependence liabilities qualitatively 

similar to schedule II substances such as 

amphetamine and methamphetamine. 

8. Whether the Substance is an 

Immediate Precursor of a Substance 

Already Controlled Under the CSA: 

Methiopropamine is not an immediate 

precursor of any controlled substance 

under the CSA as defined by 21 U.S.C 

802(23). 

Conclusion: After considering the 

scientific and medical evaluation 

conducted by HHS, HHS’s scheduling 

recommendation, and DEA’s own eightfactor analysis, DEA finds that the facts 

and all relevant data constitute 

substantial evidence of the potential for 

abuse of methiopropamine. As such, 

DEA hereby proposes to permanently 

schedule methiopropamine as a 

schedule I controlled substance under 

the CSA. 

Proposed Determination of Appropriate 

Schedule 

The CSA establishes five schedules of 

controlled substances known as 

schedules I, II, III, IV, and V. The CSA 

also outlines the findings required to 

place a drug or other substance in any 

particular schedule. 21 U.S.C. 812(b). 

After consideration of the analysis and 

recommendation of the Assistant 

Secretary for Health of HHS and review 

of all other available data, the 

Administrator, pursuant to 21 U.S.C. 

811(a) and 812(b)(1), finds that: 

1. Methiopropamine Has a High 

Potential for Abuse 

Methiopropamine, similar to the 

schedule II stimulants amphetamine 

and methamphetamine, is a stimulant 

with a high potential for abuse. In 

animals, behavioral locomotor studies 

show that methiopropamine produces 

stimulation similar to that of 

methamphetamine. As HHS mentions, 

methiopropamine abuse in humans has 

been reported in at least 16 countries, 

including North America and Europe. 

Additionally, typical stimulant effects 

such as euphoria, psychomotor 

stimulation, and anxiety have been 

described from self-reports of 

methiopropamine abusers. These effects 

are similar to those of schedule II 

stimulant such as methamphetamine 

and amphetamine. These data 

collectively indicate that 

methiopropamine has a high potential 

for abuse similar to other substances in 

schedule II such as amphetamine and 

methamphetamine. 

2. Methiopropamine Currently Has No 

Accepted Medical Use in Treatment in 

the United States 

According to HHS, FDA has not 

approved a marketing application for a 

drug product containing 

methiopropamine for any therapeutic 

indication. As HHS states, there are also 

no clinical studies or petitioners that 

claim an accepted medical use in the 

United States. In addition, as discussed 

above in the Factor 3 analysis, 

methiopropamine does not satisfy 

DEA’s five-part test for having a 

currently accepted medical use in 

treatment in the United States. 

3. There Is a Lack of Accepted Safety for 

Use of Methiopropamine Under Medical 

Supervision 

Currently, methiopropamine does not 

have an accepted medical use as noted 

by HHS. Because methiopropamine has 

no approved medical use in treatment in 

the United States and has not been 

investigated as a new drug, its safety for 

use under medical supervision has not 

been determined. Thus, there is a lack 

of accepted safety for use of 

methiopropamine under medical 

supervision. 

Although the first finding shows 

methiopropamine to have similar effects 

to schedule II substances such as 

amphetamine and methamphetamine, it 

bears reiterating that there is only one 

possible schedule in the CSA—schedule 

I—to place methiopropamine since it 

has no currently accepted medical use 

in treatment in the United States. See 

the background section for additional 

discussion. 

Based on these findings, the 

Administrator concludes that 

methiopropamine (chemical name: 

N-methyl-1-(thiophen-2-yl)propan-2- 

amine), including its salts, isomers, and 

salts of isomers, warrants control in 

schedule I of the CSA. 21 U.S.C. 

812(b)(1). More precisely, because of its 

stimulant-like effects, DEA is proposing 

to place methiopropamine in 21 CFR 

1308.11(f) (the stimulants category of 

schedule I). As such, the proposed 

control of methiopropamine includes 

the substance as well as its salts, 

isomers, and salts of isomers. 

Requirements for Handling 

Methiopropamine 

If this rule is finalized as proposed, 

methiopropamine would become 

subject to the CSA’s schedule I 

regulatory controls and administrative, 

civil, and criminal sanctions applicable 

to the manufacture, distribution, reverse 

distribution, importation, exportation, 

engagement in research, and conduct of 

instructional activities or chemical 

analysis with, and possession of 

schedule I controlled substances, 

including the following (as of the 

effective date of the planned final 

scheduling action): 

1. Registration. Any person who 

handles (manufactures, distributes, 

reverse distributes, imports, exports, 

engages in research, or conducts 

instructional activities or chemical 

analysis with, or possesses) 

methiopropamine, or who desires to 

handle methiopropamine, is required to 

be registered with DEA to conduct such 

activities pursuant to 21 U.S.C. 822, 

823, 957, and 958, and in accordance 

with 21 CFR parts 1301 and 1312 as of 

the effective date of a final scheduling 

action. Any person who currently 

handles methiopropamine, and is not 

registered with DEA, would need to 

submit an application for registration 

and may not continue to handle 

methiopropamine as of the effective 

date of a final scheduling action, unless 

DEA has approved that application for 

registration pursuant to 21 U.S.C. 822, 

823, 957, 958, and in accordance with 

21 CFR parts 1301 and 1312. 

2. Disposal of stocks. Any person who 

does not desire or is not able to obtain 

a schedule I registration would be 

required to surrender all quantities of 

currently held methiopropamine or to 

transfer all quantities of currently held 

methiopropamine to a person registered 

with DEA before the effective date of a 

final scheduling action, in accordance 

with all applicable Federal, State, local, 

and tribal laws. As of the effective date 

of a final scheduling action, 

methiopropamine would be required to 

be disposed of in accordance with 21 

CFR part 1317, in addition to all other 

applicable Federal, State, local, and 

tribal laws. 

3. Security. Methiopropamine would 

be subject to schedule I security 

requirements and would need to be 


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49272 Federal Register / Vol. 86, No. 168 / Thursday, September 2, 2021 / Proposed Rules 

handled and stored pursuant to 21 

U.S.C. 821, 823, 871(b) and in 

accordance with 21 CFR 1301.71– 

1301.93 as of the effective date of a final 

scheduling action. Non-practitioners 

handling methiopropamine would also 

need to comply with the employee 

screening requirements of 21 CFR 

1301.90–1301.93. 

4. Labeling and Packaging. All labels, 

labeling, and packaging for commercial 

containers of methiopropamine would 

need to be in compliance with 21 U.S.C. 

825 and 958(e) and be in accordance 

with 21 CFR part 1302 as of the effective 

date of a final scheduling action. 

5. Quota. Only registered 

manufacturers would be permitted to 

manufacture methiopropamine in 

accordance with a quota assigned 

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

accordance with 21 CFR part 1303 as of 

the effective date of a final scheduling 

action. 

6. Inventory. Every DEA registrant 

who possesses any quantity of 

methiopropamine on the effective date 

of a final scheduling action would be 

required to take an inventory of 

methiopropamine on hand at that time, 

pursuant to 21 U.S.C. 827 and 958 and 

in accordance with 21 CFR 1304.03, 

1304.04, and 1304.11(a) and (d). 

Any person who becomes registered 

with DEA to handle methiopropamine 

on or after the effective date of a final 

scheduling action would be required to 

have an initial inventory of all stocks of 

controlled substances (including 

methiopropamine) on hand on the date 

the registrant first engages in the 

handling of controlled substances 

pursuant to 21 U.S.C. 827 and 958, and 

in accordance with 21 CFR 1304.03, 

1304.04, and 1304.11(a) and (b). 

After the initial inventory, every DEA 

registrant must take an inventory of all 

controlled substances (including 

methiopropamine) on hand every two 

years, pursuant to 21 U.S.C. 827 and 

958, and in accordance with 21 CFR 

1304.03, 1304.04, and 1304.11. 

7. Records and Reports. Every DEA 

registrant would be required to maintain 

records and submit reports with respect 

to methiopropamine pursuant to 21 

U.S.C. 827 and 958(e) and in accordance 

with 21 CFR parts 1304 and 1312, as of 

the effective date of a final scheduling 

action. Manufacturers and distributors 

would be required to submit reports 

regarding methiopropamine to the 

Automation of Reports and 

Consolidated Order System pursuant to 

21 U.S.C. 827 and in accordance with 21 

CFR parts 1304 and 1312, as of the 

effective date of a final scheduling 

action. 

8. Order Forms. Every DEA registrant 

who distributes methiopropamine 

would be required to comply with the 

order form requirements, pursuant to 21 

U.S.C. 828 and in accordance with 21 

CFR part 1305, as of the effective date 

of a final scheduling action. 

9. Importation and Exportation. All 

importation and exportation of 

methiopropamine would need to be in 

compliance with 21 U.S.C. 952, 953, 

957, and 958, and in accordance with 21 

CFR part 1312, as of the effective date 

of a final scheduling action. 

10. Liability. Any activity involving 

methiopropamine not authorized by, or 

in violation of, the CSA or its 

implementing regulations would be 

unlawful, and may subject the person to 

administrative, civil, and/or criminal 

sanctions. 

Regulatory Analyses 

Executive Orders 12866 (Regulatory 

Planning and Review) and 13563 

(Improving Regulation and Regulatory 

Review) 

In accordance with 21 U.S.C. 811(a), 

this proposed scheduling action is 

subject to formal rulemaking procedures 

performed ‘‘on the record after 

opportunity for a hearing,’’ which are 

conducted pursuant to the provisions of 

5 U.S.C. 556 and 557. The CSA sets 

forth the criteria for scheduling a drug 

or other substance. Such actions are 

exempt from review by the Office of 

Management and Budget (OMB) 

pursuant to section 3(d)(1) of Executive 

Order (E.O.) 12866 and the principles 

reaffirmed in E.O. 13563. 

Executive Order 12988, Civil Justice 

Reform 

This proposed regulation meets the 

applicable standards set forth in 

sections 3(a) and 3(b)(2) of E.O. 12988 

to eliminate drafting errors and 

ambiguity, minimize litigation, provide 

a clear legal standard for affected 

conduct, and promote simplification 

and burden reduction. 

Executive Order 13132, Federalism 

This proposed rulemaking does not 

have federalism implications warranting 

the application of E.O. 13132. The 

proposed rule does not have substantial 

direct effects on the States, on the 

relationship between the national 

government and the States, or the 

distribution of power and 

responsibilities among the various 

levels of government. 

Executive Order 13175, Consultation 

and Coordination With Indian Tribal 

Governments 

This proposed rule does not have 

tribal implications warranting the 

application of E.O. 13175. It does not 

have substantial direct effects on one or 

more Indian tribes, on the relationship 

between the Federal government and 

Indian tribes, or on the distribution of 

power and responsibilities between the 

Federal government and Indian tribes. 

Regulatory Flexibility Act 

The Administrator, in accordance 

with the Regulatory Flexibility Act, 5 

U.S.C. 601–602, has reviewed this 

proposed rule and by approving it 

certifies that it will not have a 

significant economic impact on a 

substantial number of small entities. 

DEA proposes placing the substance 

methiopropamine (chemical name: Nmethyl-1-(thiophen-2-yl)propan-2- 

amine), including its salts, isomers, and 

salts of isomers, in schedule I of the 

CSA. This action is being taken to 

enable the United States to meet its 

obligations under the 1971 Convention 

on Psychotropic Substances. If finalized, 

this action would impose the regulatory 

controls and administrative, civil, and 

criminal sanctions applicable to 

schedule I controlled substances on 

persons who handle (manufacture, 

distribute, reverse distribute, import, 

export, engage in research, conduct 

instructional activities or chemical 

analysis with, or possess), or propose to 

handle, methiopropamine. 

According to HHS, methiopropamine 

has a high potential for abuse, has no 

currently accepted medical use in 

treatment in the United States, and lacks 

accepted safety for use under medical 

supervision. DEA’s research confirms 

that there is no legitimate commercial 

market for methiopropamine in the 

United States. Therefore, DEA estimates 

that no United States entity currently 

handles methiopropamine and does not 

expect any United States entity to 

handle methiopropamine in the 

foreseeable future. DEA concludes that 

no legitimate United States entity would 

be affected by this rule if finalized. As 

such, the proposed rule will not have a 

significant effect on a substantial 

number of small entities. 

Unfunded Mandates Reform Act of 1995 

In accordance with the Unfunded 

Mandates Reform Act (UMRA) of 1995, 

2 U.S.C. 1501 et seq., DEA has 

determined and certifies that this action 

would not result in any Federal 

mandate that may result ‘‘in the 

expenditure by State, local, and tribal 


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Federal Register / Vol. 86, No. 168 / Thursday, September 2, 2021 / Proposed Rules 49273 

1Public Law 116–260, sec. 212, 134 Stat. 1182, 

2176 (2020). 

2 86 FR 16156, 16161 (Mar. 26, 2021). Comments 

received in response to the March 26, 2021 NOI are 

available at https://www.regulations.gov/document/ 

COLC-2021-0001-0001/comment. References to 

these comments are by party name (abbreviated 

where appropriate), followed by ‘‘Initial NOI 

Comments’’ or ‘‘Reply NOI Comments,’’ as 

appropriate. 

3 17 U.S.C. 1506(aa)(1). 

4 Id. at 1506(aa)(2)(B). 

5 Id. at 1506(aa)(3)(A). 

6 Id. at 1506(aa)(3)(B). The CASE Act’s legislative 

history does not discuss the library and archives 

opt-out provision. See generally S. Rep. No. 116– 

105 (2019); H.R. Rep. No. 116–252 (2019). Note, the 

CASE Act’s legislative history cited is for S. 1273, 

116th Cong. (2019) and H.R. 2426, 116th Cong. 

(2019), the CASE Act of 2019, bills largely identical 

to the CASE Act of 2020, with the notable exception 

that these earlier bills did not contain the libraries 

and archives opt-out provision. 

7 17 U.S.C. 108. 

governments, in the aggregate, or by the 

private sector, of $100 million or more 

(adjusted annually for inflation) in any 

1 year * * *.’’ Therefore, neither a 

Small Government Agency Plan nor any 

other action is required under UMRA of 

1995. 

Paperwork Reduction Act of 1995 

This action does not impose a new 

collection of information under the 

Paperwork Reduction Act of 1995. 44 

U.S.C. 3501–3521. 

List of Subjects in 21 CFR Part 1308 

Administrative practice and 

procedure, Drug traffic control, 

Reporting and recordkeeping 

requirements. 

For the reasons set out above, DEA 

proposes to further amend 21 CFR part 

1308, which we proposed to amend on 

August 11, 2021 at 86 FR 43983, as 

follows: 

PART 1308—SCHEDULES OF 

CONTROLLED SUBSTANCES 

■ 1. The authority citation for 21 CFR 

part 1308 continues to read as follows: 

Authority: 21 U.S.C. 811, 812, 871(b), 

956(b), unless otherwise noted. 

■ 2. Amend § 1308.11 by redesignating 

paragraph (f)(9) through (f)(11) as (f)(10) 

through (f)(12) and adding new 

paragraph (f)(9) to read as follows: 

§ 1308.1 Schedule I. 

* * * * * 

(f) * * * 

(9) Methiopropamine (N-methyl-1-(thiophen-2-yl)propan-2-amine) ........................................................................................................... 1478 

* * * * * 

Anne Milgram, 

Administrator. 

[FR Doc. 2021–18843 Filed 9–1–21; 8:45 am] 

BILLING CODE 4410–09–P 

LIBRARY OF CONGRESS 

Copyright Office 

37 CFR Part 223 

[Docket No. 2021–4] 

Small Claims Procedures for Library 

and Archives Opt-Outs and Class 

Actions 

AGENCY: U.S. Copyright Office, Library 

of Congress. 

ACTION: Notice of proposed rulemaking. 

SUMMARY: The U.S. Copyright Office is 

issuing a notice of proposed rulemaking 

regarding the procedures for libraries 

and archives to opt out of proceedings 

before the Copyright Claims Board 

(‘‘CCB’’) and the procedures for a party 

before the CCB with respect to a class 

action proceeding, under the Copyright 

Alternative in Small-Claims 

Enforcement Act of 2020. The Office 

invites public comments on this 

proposed rule. 

DATES: Comments on the proposed rule 

must be made in writing and received 

by the U.S. Copyright Office no later 

than 11:59 p.m. EDT on October 4, 2021. 

ADDRESSES: For reasons of government 

efficiency, the Copyright Office is using 

the regulations.gov system for the 

submission and posting of public 

comments in this proceeding. All 

comments are therefore to be submitted 

electronically through regulations.gov. 

Specific instructions for submitting 

comments are available on the 

Copyright Office website at https://

www.copyright.gov/rulemaking/caseact-implementation/library-opt-out. If 

electronic submission of comments is 

not feasible due to lack of access to a 

computer and/or the internet, please 

contact the Office using the contact 

information below for special 

instructions. 

FOR FURTHER INFORMATION CONTACT: 

Kevin. R. Amer, Acting General Counsel 

and Associate Register of Copyrights, by 

email at kamer@copyright.gov, or John 

R. Riley, Assistant General Counsel, by 

email at jril@copyright.gov. Each can be 

contacted by telephone at (202) 707– 

8350. 

SUPPLEMENTARY INFORMATION: 

I. Background 

The Copyright Alternative in SmallClaims Enforcement (‘‘CASE’’) Act of 

2020 1 directs the Copyright Office to 

establish the Copyright Claims Board 

(‘‘CCB’’ or ‘‘Board’’), a voluntary 

tribunal within the Office comprised of 

three Copyright Claims Officers who 

have the authority to render 

determinations on certain copyright 

disputes with a low economic value. 

This notice of proposed rulemaking is 

being issued subsequent to a 

notification of inquiry (‘‘NOI’’) 

published in the Federal Register on 

March 26, 2021, which describes in 

detail the legislative background and 

regulatory scope of the present 

rulemaking proceeding.2 The Office 

assumes the reader’s familiarity with 

that document. 

A. Library and Archives Opt Out 

The CASE Act directs the Register of 

Copyrights to ‘‘establish regulations 

allowing for a library or archives that 

does not wish to participate in 

proceedings before the Copyright Claims 

Board to preemptively opt out of such 

proceedings.’’ 3 The Office must also 

‘‘compile and maintain a publicly 

available list of the libraries and 

archives that have successfully opted 

out of proceedings.’’ 4 In promulgating 

these regulations, the Register cannot 

‘‘charge a library or archives a fee to 

preemptively opt out of proceedings’’ or 

‘‘require a library or archives to renew 

a decision to preemptively opt out of 

proceedings.’’ 5

For the purposes of this provision, the 

statute defines ‘‘library’’ and ‘‘archives’’ 

as ‘‘any library or archives, respectively, 

that qualifies for the limitations on 

exclusive rights under section 108 [of 

title 17].’’ 6 Section 108 provides 

exemptions to libraries and archives 

from liability for infringement for 

specified uses of copyrighted works.7

For an institution to qualify for those 

exemptions, ‘‘the collections of the 

library or archives [must be] . . . open 

to the public, or . . . available not only 

to researchers affiliated with the library 

or archives or with the institution of 

which it is a part, but also to other 

persons doing research in a specialized 


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