Federal Register / Vol. 86, No. 138 / Thursday, July 22, 2021 / Proposed Rules 38619 

ASO NC E5 Waxhaw, NC [Amended] 

JAARS-Townsend Airport, NC 

(Lat. 34°51′50′′ N, long. 80°44′53′′ W) 

That airspace extending upward from 700 

feet above the surface within a 9.3-mile 

radius of JAARS-Townsend Airport. 

* * * * * 

ASO NC E5 Lincolnton, NC [Amended] 

Lincolnton-Lincoln County Regional, NC 

(Lat. 35°28′59′′ N, long. 81°09′41′′ W) 

That airspace extending upward from 700 

feet above the surface within an 8.5-mile 

radius of Lincolnton-Lincoln County 

Regional Airport. 

Issued in College Park, Georgia, on July 15, 

2021. 

Andreese C. Davis, 

Manager, Airspace & Procedures Team South, 

Eastern Service Center, Air Traffic 

Organization. 

[FR Doc. 2021–15452 Filed 7–21–21; 8:45 am] 

BILLING CODE 4910–13–P 

DEPARTMENT OF JUSTICE 

Drug Enforcement Administration 

21 CFR Part 1308 

[Docket No. DEA–371] 

Schedules of Controlled Substances: 

Placement of Amineptine in 

Schedule I 

AGENCY: Drug Enforcement 

Administration, Department of Justice. 

ACTION: Notice of proposed rulemaking. 

SUMMARY: The Drug Enforcement 

Administration proposes placing the 

substance amineptine (chemical name: 

7-[(10,11-dihydro-5Hdibenzo[a,d]cyclohepten-5- 

yl)amino]heptanoic acid), 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 United Nations 

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, 

amineptine. 

DATES: Comments must be submitted 

electronically or postmarked, on or 

before September 20, 2021. 

Interested persons may file a request 

for 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 

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 

fact and law asserted in the hearing, 

must be received on or before August 

23, 2021. 

ADDRESSES: Interested persons may file 

written comments on this proposal in 

accordance with 21 CFR 1308.43(g). 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. To ensure 

proper handling of comments, please 

reference ‘‘Docket No. DEA–371’’ on all 

electronic and written correspondence, 

including any attachments. 

• Electronic comments: DEA 

encourages commenters to submit all 

comments 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. Submitted 

comments are not instantaneously 

available for public view on http://

www.regulations.gov. If you have 

received a Comment Tracking Number, 

you have submitted your comment 

successfully, and there is no need to 

resubmit the same comment. 

• Paper comments: 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, send 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/LJ, 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: 

Terrence L. Boos, Drug & Chemical 

Evaluation Section, Diversion Control 

Division, Drug Enforcement 

Administration; Telephone: (571) 362– 

3249. 

SUPPLEMENTARY INFORMATION: 

Posting of Public Comments 

All comments received in response to 

this docket are considered part of the 

public record. The Drug Enforcement 

Administration (DEA) will make 

comments 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 

DEA to make it 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 DEA to make 

it 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 generally make available in 

publicly redacted form comments 

containing personal identifying 

information and confidential business 

information identified as directed 

above. If a comment has so much 

confidential business information that 

DEA cannot effectively redact it, DEA 

may not make available publicly all or 

part of that comment. 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 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. 


lotter on DSK11XQN23PROD with PROPOSALS1
38620 Federal Register / Vol. 86, No. 138 / Thursday, July 22, 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). 

2https://www.unodc.org/unodc/en/Resolutions/ 

resolution_2003-04-08_1.html. 

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 a hearing 

or notices of intent to participate in a 

hearing in conformity with the 

requirements of 21 CFR 1308.44(a) or 

(b), and they shall 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 hearing and waivers 

of participation, together with a written 

statement of position on the matters of 

fact and law involved in such 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 indicating that a drug or 

other substance has been added to a 

schedule specified in the notification, 

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 may add 

to such a schedule any drug or other 

substance, if he finds that such drug or 

other substance has a potential for 

abuse, and makes 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 

Amineptine is a synthetic tricyclic 

antidepressant with central nervous 

system (CNS) stimulating properties 

that, according to HHS, has no approved 

medical use and no known therapeutic 

application in the United States. 

Pharmacological studies indicate that 

amineptine’s primary mode of action is 

to increase extracellular levels of 

dopamine and norepinephrine as well 

as inhibit re-uptake of dopamine and 

norepinephrine within the striatum and 

limbic areas of the brain. 

In 1978, amineptine was approved for 

use in France as an antidepressant and 

subsequently marketed in 66 countries 

throughout Africa, Asia, Europe, and 

South America. As documented by the 

World Health Organization’s (WHO) 

Expert Committee on Drug Dependence 

in its 33rd report (2003) (WHO 2003 

report), amineptine has been withdrawn 

from the market in 49 of the 66 

countries. The status of current 

production of amineptine in other 

countries is not known, although a 

small quantity is most likely produced 

for research purposes. 

In April 2003, the United Nations 

Commission on Narcotic Drugs, on the 

advice of the Director-General of the 

WHO, added amineptine to Schedule II 

of the 1971 Convention, thus notifying 

all parties to the 1971 Convention.2

Because the procedures in 21 U.S.C. 

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

issuance of a temporary order for 

amineptine, 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 

amineptine. 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 

amineptine. 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 


lotter on DSK11XQN23PROD with PROPOSALS1
Federal Register / Vol. 86, No. 138 / Thursday, July 22, 2021 / Proposed Rules 38621 

3Health and Human Services (HHS) (2011). Basis 

for the Recommendation for Control of Amineptine 

in Schedule I of the Controlled Substances Act. 

4WHO’s Critical Review of Psychoactive 

Substances prepared for evaluation by the 33rd 

Meeting of the WHO Expert Committee on Drug 

Dependence held in September, in Annex, 2002.1– 

14. 

5Lachatre, G., Piva, C., Riche, C., Dumont, D., 

Defrance, R., Mocaer, E., Nicot, G. (1989). Singledose pharmacokinetics of amineptine and of its 

main metabolite in healthy young adults. 

Fundamental and Clinical Pharmacology, 3(1):19– 

26. 

6Sbarra, C., Castelli, M. G., Noseda, A., Fanelli, 

R. (1981). Pharmacokinetics of amineptine in man. 

European Journal of Drug Metabolism and 

Pharmacokinetics, 6(2), 123–126. 

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 

Amineptine 

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

gathered the necessary data on 

amineptine and, on August 12, 2008, 

submitted it to the Assistant Secretary 

for Health of HHS with a request for a 

scientific and medical evaluation of 

available information and a scheduling 

recommendation for amineptine. On 

November 8, 2011, HHS provided to 

DEA a written scientific and medical 

evaluation and scheduling 

recommendation entitled ‘‘Basis for the 

Recommendation for Control of 

Amineptine in Schedule I of the 

Controlled Substances Act.’’ In this 

recommendation, HHS presented its 

eight-factor analysis as required under 

21 U.S.C. 811(b) and recommended that 

amineptine be added to schedule I of 

the CSA. 

In response, DEA reviewed the 

scientific and medical evaluation and 

scheduling recommendation provided 

by HHS and all other relevant data and 

conducted its own eight-factor analysis 

pursuant to 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 the scheduling 

decision. Both DEA and HHS analyses 

are available in their entirety under 

‘‘Supporting and Related Material’’ of 

the public docket for this rule at http:// 

www.regulations.gov under docket 

number DEA–371. 

1. The Drug’s Actual or Relative 

Potential for Abuse: As reported by 

HHS, the WHO 2003 report showed 

strong evidence of abuse in Europe and 

Asia, where amineptine was approved 

for use as an antidepressant. Additional 

HHS findings showed that due to 

reports of hepatotoxicity and abuse in 

Europe, Servier (a French 

pharmaceutical company) voluntarily 

discontinued the French marketing 

authorization in France and Spain for 

amineptine in 1999 (HHS, 2011; 3 WHO, 

2002 4). However, as documented by the 

WHO 2003 report, the medical use of 

amineptine and its abuse in developing 

countries still existed during 1990 to 

2003. Clinical studies used between 

100—200 mg of amineptine (Lachatre et 

al., 1989; 5 Sbarra et al., 1981 6); 

however, case reports from various 

countries (none in the United States due 

to its lack of approved medical use or 

known therapeutic application in the 

United States) have reported 

hospitalizations due to amineptine 

abuse and overdose following the 

ingestion of 2,000–4,300 mg and even 

up to 12 g daily. However, adverse 

effects at prescribed doses of amineptine 

were still observed (see Factor 6). 

Evidence shows that amineptine 

produces behavioral effects in humans 

and animals that are similar to 

amphetamine and cocaine (both in 

schedule II). Pharmacological studies 

have demonstrated that amineptine has 

reinforcing effects as shown by the selfadministration test and has locomotor 

stimulant effects. Studies also have 

shown that amineptine increases 

extracellular concentrations of 

dopamine in the brain, particularly in 

the striatum and nucleus accumbens, 

which are structures constituting the 

reward pathway and are known to be 

involved in the abuse of drugs, 

including amphetamine and cocaine. 

The above data indicate that amineptine 

has the potential for abuse similar to 

other CNS stimulants controlled under 

the CSA, such as cocaine and 

amphetamine. 

2. Scientific Evidence of the Drug’s 

Pharmacological Effects, if Known: As 

stated by HHS, amineptine increases 

dopamine levels by inducing the 

synaptosomal release and inhibition of 

dopamine re-uptake and, to a lesser 

extent, increasing norepinephrine 

levels, a mode of action mechanistically 

similar to the known schedule II CNS 

stimulants amphetamine and cocaine. 

Animal behavioral studies have shown 

that amineptine, in addition to its CNS 

stimulant properties, has antidepressant, locomotor, and antinarcoleptic activities. Human behavioral 

studies have demonstrated that 

amineptine works similarly to other 

antidepressants, often with an earlier 

onset of therapeutic effects. Studies 

have shown that amineptine 

administration lowers depression rating 

scales in patients and results in a 

positive subjective quality of sleep and 

subsequent increase in attention and 

concentration upon waking. 

3. The State of Current Scientific 

Knowledge Regarding the Drug or Other 

Substance: The chemical name of 

amineptine is 7-[(10,11-dihydro-5Hdibenzo[a,d]cyclohepten-5- 

yl)amino]heptanoic acid. It is a white, 

crystalline powder and is soluble in 

water and in methanol. Humans rapidly 

absorb amineptine after oral 

administration, with mean peak plasma 

concentrations of amineptine and its 

main metabolite occurring at 1 hour and 

1.5 hours, respectively. Amineptine is 

metabolized in the liver and rapidly 

excreted and eliminated through the 

kidneys with mean half-lives of 0.8 

hours for amineptine and 2.5 hours for 

its metabolite. In humans, 70–75 

percent of the administered dose of 

amineptine was excreted in the urine 

within 48 hours, with most of the 

elimination occurring within the first 12 

hours. 

Distribution of 14C-amineptine was 

also evaluated in the Macaca 

fascicularis monkey using whole body 

autoradiography. Results demonstrated 

high levels of radio-labeled amineptine 

in the liver and kidneys, with lower 

levels of activity in the blood, 

gastrointestinal tract and spleen. In the 

brain, radioactivity was observed in the 

cortex, putamen, caudate nucleus, 

globus pallidus, pulvinar, and 

geniculate bodies, with lower levels 

noted in the hippocampus, substantia 

nigra, and medulla. 

4. Its History and Current Pattern of 

Abuse: As mentioned by HHS, there are 

numerous published reports of 

amineptine abuse, including 186 cases 

of abuse between 1978 and 1988 

reported to the Regional Centers of 

Pharmacovigilance and the Laboratory 

Eutherapie in France, and 65 cases of 

abuse between 1990 and 1998 appearing 

in the Observation of Illegal Drugs and 

Misuse of Psychotropic Medications 

database. Notably, amineptine has not 

been approved for medical use in the 

United States nor is there any 


lotter on DSK11XQN23PROD with PROPOSALS1
38622 Federal Register / Vol. 86, No. 138 / Thursday, July 22, 2021 / Proposed Rules 

7STRIDE is a database of drug exhibits sent to 

DEA laboratories for analysis. Exhibits from the 

database are from DEA, other federal agencies, and 

law enforcement agencies. On October 1, 2014, 

STARLiMS replaced STRIDE as DEA laboratory 

drug evidence data system of record. 

8NFLIS is a national drug forensic laboratory 

reporting system that systematically collects results 

from drug chemistry analyses conducted by state 

and local forensic laboratories across the country. 

The NFLIS participation rate, defined as the 

percentage of the national drug caseload 

represented by laboratories that have joined NFLIS, 

is over 97%. NFLIS includes drug chemistry results 

from completed analyses only. 

9Although there is no evidence suggesting that 

amineptine 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, to have a currently 

accepted medical use in treatment in the United 

States, all of the following must be demonstrated: 

i. the drug’s chemistry must be known and 

reproducible; ii. there must be adequate safety 

studies; iii. there must be adequate and wellcontrolled studies proving efficacy; iv. the drug 

must be accepted by qualified experts; and v. the 

scientific evidence must be 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). 

documented abuse in the United States 

of amineptine. 

At the 16th French Pharmacovigilance 

meeting in November 1994, the Fernand 

Widal Pharmacovigilance Centre 

reviewed 565 cases of amineptine 

‘‘overconsumption’’ from 1978 to 1993, 

and reported multiple characteristics of 

amineptine abuse including: (1) 

Amineptine abusers typically had a 

history of alcoholism, drug abuse, and/ 

or eating disorders; (2) 28 percent of the 

cases of amineptine abuse resulted in 

neuropsychiatric disorders; (3) 11 

percent of patients developed acne-like 

lesions from amineptine use; (4) 

withdrawal from amineptine abuse was 

described as extremely difficult; (5) only 

30 percent were abstinent after one 

month of withdrawal and long-term 

abstinence was uncommon; and (6) 

most patients obtained amineptine from 

pharmacists by prescription theft or by 

fraudulent prescriptions. Collectively, 

these three reports show that there has 

been a continued pattern of abuse from 

1978 to 1998. 

DEA noted that in the WHO 2003 

report, the WHO’s Expert Committee on 

Drug Dependence stated that the degree 

of risk to public health associated with 

the abuse liability of amineptine is 

substantial, while noting several adverse 

effects including hepatotoxicity, severe 

acne, and anxiety. The committee also 

noted the limited therapeutic usefulness 

of amineptine due to the availability of 

safer antidepressants. 

Queries of DEA’s System to Retrieve 

Information from Drug Evidence 

(STRIDE)/STARLiMS 7 and the National 

Forensic Laboratory Information System 

(NFLIS) 8 databases on November 17, 

2020, did not generate any reports of 

amineptine, suggesting that it is not 

trafficked in the United States. 

5. The Scope, Duration, and 

Significance of Abuse: According to the 

published case reports from 1984 to 

2001 in France, Italy, Pakistan, 

Singapore, and Spain, the majority of 

the reported cases of amineptine abuse 

involved patients who were prescribed 

amineptine for an affective disorder. In 

these cases, abuse normally began one 

year after amineptine was prescribed for 

the treatment of depression by patients 

independently increasing their dosage, 

especially in those with a history of 

alcoholism, intravenous drug abuse, and 

eating disorders. 

Amineptine abuse appears to be due 

to its psychostimulant effect. Indeed, 

reasons cited for its abuse were 

increased energy, joy, work output, 

alertness, and psychomotor 

performance. Presently, although 

internet searches result in websites with 

purported amineptine for sale, these 

sites do not list the formulation, purity, 

price, and quantity for this purported 

amineptine. In addition, the 1971 

Convention currently controls 

amineptine internationally as a 

Schedule II substance. Amineptine is 

also controlled in Belgium, Canada, the 

Czech Republic, Denmark, Estonia, 

Germany, Greece, Hungary, Italy, Latvia, 

Lithuania, the Netherlands, Norway, 

Poland, Slovenia, and Sweden. 

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

Public Health: As reported by HHS, 

there are no known fatalities resulting 

from amineptine use or abuse. Some of 

the main public health risks of 

amineptine are related to its serious 

adverse effects, such as hepatotoxicity, 

severe acne, and gastrointestinal (acute 

pancreatitis) effects. In addition, 

neuropsychiatric symptoms including 

anxiety, insomnia, nervousness, 

irritability, dysarthria, acute psychosis, 

delusions, hallucinations, anorexia, 

agitation, psychotic disorders, and 

confusion have resulted from abuse of 

amineptine. 

7. Its Psychic or Physiological 

Dependence Liability: HHS stated that 

amineptine has been shown to produce 

physical and psychological dependence 

as supported by clinical evidence. 

While amineptine has no clearly 

defined withdrawal syndrome, reports 

of withdrawal symptoms include 

anxiety, dysphoria, nausea, brief 

psychotic episodes, tremor, 

psychomotor agitation, somatic 

symptoms, and sleep disturbances. In 

addition, a strong desire to take 

amineptine was noted in individuals 

upon withdrawal of the drug, a typical 

characteristic of psychological 

dependence. 

8. Whether the Substance is an 

Immediate Precursor of a Substance 

Already Controlled under the CSA: DEA 

and HHS find that amineptine is not an 

immediate precursor of a substance 

already controlled under the CSA. 

Conclusion: Based on consideration of 

the scientific and medical evaluation 

and accompanying recommendation of 

HHS, and based on DEA’s consideration 

of its own eight-factor analysis, DEA 

finds that these facts and all relevant 

data constitute substantial evidence of 

potential for abuse of amineptine. As 

such, DEA hereby proposes to schedule 

amineptine as a 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 

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 available data, the Administrator 

of DEA, pursuant to 21 U.S.C. 812(b)(1), 

finds that: 

(1) Amineptine has a high potential 

for abuse. Amineptine has stimulant 

and euphoric effects similar to cocaine 

and amphetamine, which are both 

schedule II drugs. Amineptine has a 

high potential for abuse that is 

equivalent to cocaine and amphetamine 

and has been abused throughout Europe 

and Asia. 

(2) Amineptine has no currently 

accepted medical use in treatment in the 

United States. There are no approved 

New Drug Applications for amineptine 

and no known therapeutic application 

for amineptine in the United States. 

Therefore, amineptine has no currently 

accepted medical use in treatment in the 

United States.9

(3) There is a lack of accepted safety 

for use of amineptine under medical 

supervision. Clinical experience showed 

that patients taking amineptine under 

medical supervision for depression 

misused and abused the drug by stealing 

or falsifying prescriptions and taking 

doses that were 10 to 20 times higher 

than prescribed. As a result of taking 

higher doses, many patients developed 

hepatic, gastrointestinal, cardiovascular, 

and psychiatric side effects. Amineptine 

was once marketed in 66 countries 

throughout Europe, Africa, Asia, and 


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Federal Register / Vol. 86, No. 138 / Thursday, July 22, 2021 / Proposed Rules 38623 

South America. However, amineptine 

was later withdrawn from the majority 

of countries due to its abuse potential 

and lack of safety. Therefore, there is a 

lack of accepted safety for the use of 

amineptine under medical supervision. 

Although the first finding shows 

amineptine to have similar effects to 

schedule II substances such as cocaine 

and amphetamine, it bears reiterating 

that there is only one possible schedule 

in the CSA—schedule I—to place 

amineptine 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 of DEA concludes that 

amineptine warrants control in schedule 

I of the CSA. 21 U.S.C. 812(b)(1). More 

precisely, because of its stimulant 

effects, DEA proposes placing substance 

amineptine, including its salts, isomers, 

and salts of isomers, in 21 CFR 

1308.11(f) (the stimulants category of 

schedule I). 

Requirements for Handling Amineptine 

If this rule is finalized as proposed, 

amineptine would be subject to the 

CSA’s schedule I regulatory controls 

and administrative, civil, and criminal 

sanctions applicable to the manufacture, 

distribution, reverse distribution, 

import, export, engagement in research, 

conduct of instructional activities or 

chemical analysis with, and possession 

of schedule I controlled substances, 

including the following: 

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) amineptine, 

or who desires to handle amineptine, 

would need to be registered with DEA 

to conduct such activities pursuant to 

21 U.S.C. 822, 823, 957, 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 amineptine and is not 

registered with DEA would need to 

submit an application for registration 

and may not continue to handle 

amineptine 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 or to transfer all 

quantities of currently held amineptine 

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, amineptine 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. Amineptine would be 

subject to schedule I security 

requirements and would need to be 

handled and stored pursuant to 21 

U.S.C. 821 and 823 and in accordance 

with 21 CFR 1301.71–1301.93, as of the 

effective date of a final scheduling 

action. Non-practitioners handling 

amineptine 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 amineptine would need to 

be in compliance with 21 U.S.C. 825 

and 958(e) and 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 amineptine 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 

amineptine on the effective date of a 

final scheduling action would be 

required to take an inventory of 

amineptine 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 on or after the effective date 

of the final scheduling action would be 

required to take an initial inventory of 

all stocks of controlled substances 

(including amineptine) 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 would be required to take a 

new inventory of all controlled 

substances (including amineptine) 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 for 

amineptine, or products containing 

amineptine, pursuant to 21 U.S.C. 827 

and 958 and in accordance with 21 CFR 

parts 1304, 1312, and 1317, as of the 

effective date of a final scheduling 

action. Manufacturers and distributors 

would be required to submit reports 

regarding amineptine 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 amineptine would be 

required to comply with 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 

amineptine 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 

amineptine 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 and 13563, 

Regulatory Planning and Review, and 

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 procedures and criteria for 

scheduling a drug or other substance. 

Such actions are exempt from review by 

the Office of Management and Budget 

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, 

Civil Justice Reform, 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 


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38624 Federal Register / Vol. 86, No. 138 / Thursday, July 22, 2021 / Proposed Rules 

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. 

Paperwork Reduction Act of 1995 

This action does not impose a new 

collection of information requirement 

under the Paperwork Reduction Act of 

1995 (44 U.S.C. 3501–3521). 

Regulatory Flexibility Act 

The Administrator of DEA, in 

accordance with the Regulatory 

Flexibility Act, 5 U.S.C. 601–612, 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 

amineptine, including its isomers, salts, 

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. 

If finalized, this action would impose 

the regulatory controls and 

administrative, civil, and/or 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, 

amineptine. 

According to HHS, amineptine 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 commercial market for 

amineptine in the United States. 

Additionally, queries of DEA’s STRIDE/ 

STARLiMS and the NFLIS databases on 

November 17, 2020, did not generate 

any reports of amineptine, suggesting 

that it is not trafficked in the United 

States. Therefore, DEA estimates that no 

United States entity currently handles 

amineptine and does not expect any 

United States entity to handle 

amineptine in the foreseeable future. 

DEA concludes that no 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 

On the basis of information contained 

in the ‘‘Regulatory Flexibility Act’’ 

section above, DEA has determined 

pursuant to the Unfunded Mandates 

Reform Act (UMRA) of 1995 (2 U.S.C. 

1501 et seq.) that this action would not 

result in any Federal mandate that may 

result ‘‘in the expenditure by State, 

local, and tribal governments, in the 

aggregate, or by the private sector, of 

$100,000,000 or more (adjusted 

annually for inflation) in any 1 year 

* * *.’’ Therefore, neither a Small 

Government Agency Plan nor any other 

action is required under provisions of 

the UMRA of 1995. 

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, 21 CFR 

part 1308 is proposed to be amended to 

read 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 re-designating 

paragraphs (f)(1) through (f)(9) as 

paragraphs (f)(2) through (f)(10), and 

adding a new paragraph (f)(1) to read as 

follows: 

§ 1308.11 Schedule I. 

* * * * * 

(f) * * * 

(1) Amineptine (7-[(10,11-dihydro-5H-dibenzo[a,d]cyclohepten-5-yl)amino]heptanoic acid) ...................................................... 1219 

* * * * * 

Anne Milgram, 

Administrator. 

[FR Doc. 2021–15331 Filed 7–21–21; 8:45 am] 

BILLING CODE 4410–09–P 

DEPARTMENT OF JUSTICE 

28 CFR Part 16 

[CPCLO Order No. 003–2021] 

Privacy Act of 1974; Implementation 

AGENCY: United States Department of 

Justice. 

ACTION: Notice of proposed rulemaking. 

SUMMARY: On July 14, 2021 in the 

publication of the Federal Register at 86 

FR 37188, the Department of Justice 

(Department or DOJ), has published a 

notice of a modified system of records 

that was retitled as, ‘‘Department of 

Justice Information Technology, 

Information System, and Network 

Activity and Access Records,’’ JUSTICE/ 

DOJ–002. In this notice of proposed 

rulemaking, DOJ proposes to exempt 

this system of records from certain 

provisions of the Privacy Act in order to 

avoid interference with the efforts of 

DOJ and others to prevent the 

unauthorized access, use, disclosure, 

disruption, modification, or destruction 

of DOJ information and information 

systems, and to protect information on 

DOJ classified networks. For the reasons 

provided below, the Department 

proposes to amend its Privacy Act 

regulations by establishing an 

exemption for records in this system 

from certain provisions of the Privacy 

Act. Public comment is invited. 

DATES: Comments must be received by 

August 23, 2021. 

ADDRESSES: You may send comments by 

any of the following methods: 

• Federal eRulemaking Portal: http:// 

www.regulations.gov. When submitting 

comments electronically, you must 

include the CPCLO Order No. in the 

subject box. Please note that the 

Department is requesting that electronic 

comments be submitted before midnight 

Eastern Standard Time on the day the 

comment period closes because http://

www.regulations.gov terminates the 

public’s ability to submit comments at 

that time. Commenters in time zones 

other than Eastern Standard Time may 

want to consider this so that their 

electronic comments are received. 

• Mail: United States Department of 

Justice, Office of Privacy and Civil 

Liberties, ATTN: Privacy Analyst, Office 

of Privacy and Civil Liberties, 145 N St. 

NE, Suite 8W.300, Washington, DC 

20530. All comments sent via regular or 

express mail will be considered timely 

if postmarked on the day the comment 

period closes. To ensure proper 

handling, please reference the CPCLO 

Order No. in your correspondence. 

Posting of Public Comments: 

Interested persons are invited to 


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