34164 Federal Register / Vol. 87, No. 108 / Monday, June 6, 2022 / Rules and Regulations 

Country Entity License 

requirement 

License 

review policy 

Federal Register 

citation 

St. Petersburg Shipbuilding Institution Krylov 

45, a.k.a., the following one alias: 

—Krylov State Research Center. 

44 Moskovskoe Highway, St. Petersburg, 

Russia, 196158. 

For all items subject to the 

EAR. (See §§ 734.9(g),3

746.8(a)(3), and 744.21(b) 

of the EAR.) 

Policy of denial for all items 

subject to the EAR apart 

from food and medicine 

designated as EAR99, 

which will be reviewed on a 

case-by-case basis. See 

§§ 746.8(b) and 744.21(e).

87 FR [INSERT FR PAGE 

NUMBER] 6/6/2022. 

******

Strategic Control Posts Corporation, a.k.a., 

the following two aliases: 

—Central Design Bureau of Heavy Machine 

Building SPU TsKB TM; and 

—JSC Corporation SPU–CCB TM. 

12A Vozvodnaya St., Moscow, 111024, Russia. 

For all items subject to the 

EAR. (See §§ 734.9(g),3

746.8(a)(3), and 744.21(b) 

of the EAR.) 

Policy of denial for all items 

subject to the EAR apart 

from food and medicine 

designated as EAR99, 

which will be reviewed on a 

case-by-case basis. See 

§§ 746.8(b) and 744.21(e).

87 FR [INSERT FR PAGE 

NUMBER] 6/6/2022. 

******

Systems of Biological Synthesis LLC., a.k.a., 

the following three aliases: 

—Sistemy Biologicheskogo Sinteza; 

—OOO SBS; and 

—SBS LLC. 

Akademika Koroleva Street, Building 13/1, 

Office 35–39, Moscow, 129515, Russia. 

For all items subject to the 

EAR (See § 744.11 of the 

EAR). 

Policy of Denial ...................... 87 FR [INSERT FR PAGE 

NUMBER] 6/6/2022. 

TsKB MT Rubin, a.k.a., the following two 

aliases: 

—Tsentralnoe Konstruktorskoe Byuro 

Morskoi Tekhniki Rubin; and 

—The Rubin Central Design Bureau for Marine Engineering. 

90 Marata Street, Saint Petersburg, 191119, 

Russia. 

For all items subject to the 

EAR. (See §§ 734.9(g),3

746.8(a)(3), and 744.21(b) 

of the EAR.) 

Policy of denial for all items 

subject to the EAR apart 

from food and medicine 

designated as EAR99, 

which will be reviewed on a 

case-by-case basis. See 

§§ 746.8(b) and 744.21(e).

87 FR [INSERT FR PAGE 

NUMBER] 6/6/2022. 

******

V.A. Trapeznikov Institute of Control 

Sciences of Russian Academy of 

Sciences, a.k.a., the following two aliases: 

—ICS RAS; and 

—IPU RAS. 

65 Profsoyuznaya Street, Business Center 

Vozdvizhenka Center Voentorg, Moscow, 

117997, Russia. 

For all items subject to the 

EAR. (See §§ 734.9(g),3

746.8(a)(3), and 744.21(b) 

of the EAR.) 

Policy of denial for all items 

subject to the EAR apart 

from food and medicine 

designated as EAR99, 

which will be reviewed on a 

case-by-case basis. See 

§§ 746.8(b) and 744.21(e).

87 FR [INSERT FR PAGE 

NUMBER] 6/6/2022. 

Vladimir Design Bureau for Radio Communications OJSC, a.k.a., the following one 

alias: 

—VKBR. 

28 Baturina St., Vladimir, Vladimirskaya oblast, 600017, Russia. 

For all items subject to the 

EAR. (See §§ 734.9(g),3

746.8(a)(3), and 744.21(b) 

of the EAR.) 

Policy of denial for all items 

subject to the EAR apart 

from food and medicine 

designated as EAR99, 

which will be reviewed on a 

case-by-case basis. See 

§§ 746.8(b) and 744.21(e).

87 FR [INSERT FR PAGE 

NUMBER] 6/6/2022. 

Voentelecom JSC, 

15A/1 Bolshaya Olenya St., Moscow, 

107014, Russia. 

For all items subject to the 

EAR. (See §§ 734.9(g),3

746.8(a)(3), and 744.21(b) 

of the EAR.) 

Policy of denial for all items 

subject to the EAR apart 

from food and medicine 

designated as EAR99, 

which will be reviewed on a 

case-by-case basis. See 

§§ 746.8(b) and 744.21(e).

87 FR [INSERT FR PAGE 

NUMBER] 6/6/2022. 

******

* * * * * 

Thea D. Rozman Kendler, 

Assistant Secretary for Export 

Administration. 

[FR Doc. 2022–12144 Filed 6–2–22; 4:15 pm] 

BILLING CODE 3510–JT–P 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Food and Drug Administration 

21 CFR Part 876 

[Docket No. FDA–2022–N–0790] 

Medical Devices; GastroenterologyUrology Devices; Classification of the 

Non-Implanted Electrical Stimulation 

Device for Management of Premature 

Ejaculation 

AGENCY: Food and Drug Administration, 

HHS. 

ACTION: Final amendment; final order. 

SUMMARY: The Food and Drug 

Administration (FDA, Agency, or we) is 

classifying the non-implanted electrical 

stimulation device for management of 

premature ejaculation into class II 

(special controls). The special controls 

that apply to the device type are 

identified in this order and will be part 

of the codified language for the nonimplanted electrical stimulation device 

for management of premature 

ejaculation’s classification. We are 

taking this action because we have 

determined that classifying the device 

into class II (special controls) will 

provide a reasonable assurance of safety 

and effectiveness of the device. We 

believe this action will also enhance 

patients’ access to beneficial innovative 

devices. 


lotter on DSK11XQN23PROD with RULES1
Federal Register / Vol. 87, No. 108 / Monday, June 6, 2022 / Rules and Regulations 34165 

1FDA notes that the ‘‘ACTION’’ caption for this 

final order is styled as ‘‘Final amendment; final 

order,’’ rather than ‘‘Final order.’’ Beginning in 

December 2019, this editorial change was made to 

indicate that the document ‘‘amends’’ the Code of 

Federal Regulations. The change was made in 

accordance with the Office of Federal Register’s 

(OFR) interpretations of the Federal Register Act (44 

U.S.C. chapter 15), its implementing regulations (1 

CFR 5.9 and parts 21 and 22), and the Document 

Drafting Handbook. 

DATES: This order is effective June 6, 

2022. The classification was applicable 

on November 23, 2021. 

FOR FURTHER INFORMATION CONTACT: Feba 

Abraham, Center for Devices and 

Radiological Health, Food and Drug 

Administration, 10903 New Hampshire 

Ave., Bldg. 66, Rm. 2647, Silver Spring, 

MD 20993–0002, 307–796–5772, 

Feba.Abraham@fda.hhs.gov. 

SUPPLEMENTARY INFORMATION: 

I. Background 

Upon request, FDA has classified the 

non-implanted electrical stimulation 

device for management of premature 

ejaculation as class II (special controls), 

which we have determined will provide 

a reasonable assurance of safety and 

effectiveness. In addition, we believe 

this action will enhance patients’ access 

to beneficial innovation, in part by 

placing the device into a lower device 

class than the automatic class III 

assignment. 

The automatic assignment of class III 

occurs by operation of law and without 

any action by FDA, regardless of the 

level of risk posed by the new device. 

Any device that was not in commercial 

distribution before May 28, 1976, is 

automatically classified as, and remains 

within, class III and requires premarket 

approval unless and until FDA takes an 

action to classify or reclassify the device 

(see 21 U.S.C. 360c(f)(1)). We refer to 

these devices as ‘‘postamendments 

devices’’ because they were not in 

commercial distribution prior to the 

date of enactment of the Medical Device 

Amendments of 1976, which amended 

the Federal Food, Drug, and Cosmetic 

Act (FD&C Act). 

FDA may take a variety of actions in 

appropriate circumstances to classify or 

reclassify a device into class I or II. We 

may issue an order finding a new device 

to be substantially equivalent under 

section 513(i) of the FD&C Act (see 21 

U.S.C. 360c(i)) to a predicate device that 

does not require premarket approval. 

We determine whether a new device is 

substantially equivalent to a predicate 

device by means of the procedures for 

premarket notification under section 

510(k) of the FD&C Act (21 U.S.C. 

360(k)) and part 807 (21 CFR part 807). 

FDA may also classify a device 

through ‘‘De Novo’’ classification, a 

common name for the process 

authorized under section 513(f)(2) of the 

FD&C Act. Section 207 of the Food and 

Drug Administration Modernization Act 

of 1997 (Pub. L. 105–115) established 

the first procedure for De Novo 

classification. Section 607 of the Food 

and Drug Administration Safety and 

Innovation Act (Pub. L. 112–144) 

modified the De Novo application 

process by adding a second procedure. 

A device sponsor may utilize either 

procedure for De Novo classification. 

Under the first procedure, the person 

submits a 510(k) for a device that has 

not previously been classified. After 

receiving an order from FDA classifying 

the device into class III under section 

513(f)(1) of the FD&C Act, the person 

then requests a classification under 

section 513(f)(2). 

Under the second procedure, rather 

than first submitting a 510(k) and then 

a request for classification, if the person 

determines that there is no legally 

marketed device upon which to base a 

determination of substantial 

equivalence, that person requests a 

classification under section 513(f)(2) of 

the FD&C Act. 

Under either procedure for De Novo 

classification, FDA is required to 

classify the device by written order 

within 120 days. The classification will 

be according to the criteria under 

section 513(a)(1) of the FD&C Act. 

Although the device was automatically 

placed within class III, the De Novo 

classification is considered to be the 

initial classification of the device. 

When FDA classifies a device into 

class I or II via the De Novo process, the 

device can serve as a predicate for 

future devices of that type, including for 

510(k)s (see section 513(f)(2)(B)(i) of the 

FD&C Act). As a result, other device 

sponsors do not have to submit a De 

Novo request or premarket approval 

application to market a substantially 

equivalent device (see section 513(i) of 

the FD&C Act, defining ‘‘substantial 

equivalence’’). Instead, sponsors can use 

the less-burdensome 510(k) process, 

when necessary, to market their device. 

II. De Novo Classification 

On March 30, 2021, FDA received 

Virility Medical’s request for De Novo 

classification of the vPatch. FDA 

reviewed the request in order to classify 

the device under the criteria for 

classification set forth in section 

513(a)(1) of the FD&C Act. 

We classify devices into class II if 

general controls by themselves are 

insufficient to provide reasonable 

assurance of safety and effectiveness, 

but there is sufficient information to 

establish special controls that, in 

combination with the general controls, 

provide reasonable assurance of the 

safety and effectiveness of the device for 

its intended use (see 21 U.S.C. 

360c(a)(1)(B)). After review of the 

information submitted in the request, 

we determined that the device can be 

classified into class II with the 

establishment of special controls. FDA 

has determined that these special 

controls, in addition to the general 

controls, will provide reasonable 

assurance of the safety and effectiveness 

of the device. 

Therefore, on November 23, 2021, 

FDA issued an order to the requester 

classifying the device into class II. In 

this final order, FDA is codifying the 

classification of the device by adding 21 

CFR 876.5026.1 We have named the 

generic type of device non-implanted 

electrical stimulation device for 

management of premature ejaculation, 

and it is identified as a device intended 

to be used in patients with premature 

ejaculation by delivery of electrical 

stimulation to the perineal muscles and 

nerves. 

FDA has identified the following risks 

to health associated specifically with 

this type of device and the measures 

required to mitigate these risks in table 

1. 

TABLE 1—NON-IMPLANTED ELECTRICAL STIMULATION DEVICE FOR

MANAGEMENT OF PREMATURE

EJACULATION RISKS AND MITIGATION

MEASURES

Identified risks to 

health Mitigation measures 

Use error leading to 

patient pain, discomfort, or injury.

Labeling. 

Electrical, mechanical 

or thermal fault, 

system malfunction, 

or other device failure resulting in lack 

of treatment or patient discomfort/injury (e.g., electrical 

shock, burn, tissue 

damage, or interference from other 

medical devices or 

electrical equipment).

Non-clinical performance testing; 

Electrical safety testing; 

Electromagnetic compatibility testing; 

Software validation, 

verification, and 

hazard analysis; 

Shelf-life testing; and 

Labeling. 

Adverse tissue reaction.Biocompatibility evaluation, and 

Labeling. 

FDA has determined that special 

controls, in combination with the 

general controls, address these risks to 

health and provide reasonable assurance 

of safety and effectiveness. For a device 

to fall within this classification, and 


lotter on DSK11XQN23PROD with RULES1
34166 Federal Register / Vol. 87, No. 108 / Monday, June 6, 2022 / Rules and Regulations 

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). 

2 21 U.S.C. 811(d)(3). 

thus avoid automatic classification in 

class III, it would have to comply with 

the special controls named in this final 

order. The necessary special controls 

appear in the regulation codified by this 

order. This device is subject to 

premarket notification requirements 

under section 510(k) of the FD&C Act. 

III. Analysis of Environmental Impact 

The Agency has determined under 21 

CFR 25.34(b) that this action is of a type 

that does not individually or 

cumulatively have a significant effect on 

the human environment. Therefore, 

neither an environmental assessment 

nor an environmental impact statement 

is required. 

IV. Paperwork Reduction Act of 1995 

This final order establishes special 

controls that refer to previously 

approved collections of information 

found in other FDA regulations and 

guidance. These collections of 

information are subject to review by the 

Office of Management and Budget 

(OMB) under the Paperwork Reduction 

Act of 1995 (44 U.S.C. 3501–3521). The 

collections of information in 21 CFR 

part 860, subpart D, regarding De Novo 

classification have been approved under 

OMB control number 0910–0844; the 

collections of information in 21 CFR 

part 814, subparts A through E, 

regarding premarket approval, have 

been approved under OMB control 

number 0910–0231; the collections of 

information in part 807, subpart E, 

regarding premarket notification 

submissions, have been approved under 

OMB control number 0910–0120; the 

collections of information in 21 CFR 

part 820, regarding quality system 

regulation, have been approved under 

OMB control number 0910–0073; and 

the collections of information in 21 CFR 

part 801, regarding labeling, have been 

approved under OMB control number 

0910–0485. 

List of Subjects in 21 CFR Part 876 

Medical devices. 

Therefore, under the Federal Food, 

Drug, and Cosmetic Act and under 

authority delegated to the Commissioner 

of Food and Drugs, 21 CFR part 876 is 

amended as follows: 

PART 876—GASTROENTEROLOGY– 

UROLOGY DEVICES 

■ 1. The authority citation for part 876 

continues to read as follows: 

Authority: 21 U.S.C. 351, 360, 360c, 360e, 

360j, 360l, 371. 

■ 2. Add § 876.5026 to subpart F to read 

as follows: 

§ 876.5026 Non-implanted electrical 

stimulation device for management of 

premature ejaculation. 

(a) Identification. A non-implanted 

electrical stimulation device for 

management of premature ejaculation is 

intended to be used in patients with 

premature ejaculation by delivery of 

electrical stimulation to the perineal 

muscles and nerves. 

(b) Classification. Class II (special 

controls). The special controls for this 

device are: 

(1) The device must be demonstrated 

to be biocompatible. 

(2) Performance testing must 

demonstrate the electromagnetic 

compatibility, electrical safety, and 

thermal safety of the device. 

(3) Non-clinical performance testing 

must demonstrate that the device 

performs as intended under anticipated 

conditions of use. The following 

performance characteristics must be 

tested: 

(i) Mechanical performance; 

(ii) Electrical stimulation parameters; 

and 

(iii) Battery performance. 

(4) Performance testing must support 

shelf life by demonstrating continued 

device functionality over the identified 

shelf life. 

(5) Software verification, validation, 

and hazard analysis must be performed. 

(6) Labeling must include: 

(i) Specific instructions regarding safe 

placement and correct use of the device; 

(ii) Warning(s) against use by patients 

with active implanted medical devices; 

and 

(iii) A shelf life. 

Dated: May 26, 2022. 

Lauren K. Roth, 

Associate Commissioner for Policy. 

[FR Doc. 2022–12082 Filed 6–3–22; 8:45 am] 

BILLING CODE 4164–01–P 

DEPARTMENT OF JUSTICE 

Drug Enforcement Administration 

21 CFR Part 1308 

[Docket No. DEA–568] 

Schedules of Controlled Substances: 

Placement of Methoxetamine (MXE) in 

Schedule I 

AGENCY: Drug Enforcement 

Administration, Department of Justice. 

ACTION: Final rule. 

SUMMARY: With the issuance of this final 

rule, the Drug Enforcement 

Administration places 2-(ethylamino)-2- 

(3-methoxyphenyl)cyclohexan-1-one 

(methoxetamine, MXE), including its 

salts, isomers, and salts of isomers 

whenever the existence of such salts, 

isomers, and salts of isomers is possible 

within the specific chemical 

designation, in schedule I of the 

Controlled Substances Act to enable the 

United States to meet its obligations 

under the 1971 Convention on 

Psychotropic Substances. This action 

imposes 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, 

methoxetamine. 

DATES: Effective July 6, 2022. 

FOR FURTHER INFORMATION CONTACT: 

Terrence L. Boos, Drug & Chemical 

Evaluation Section, Diversion Control 

Division, Drug Enforcement 

Administration; Telephone: (571) 362– 

3249. 

SUPPLEMENTARY INFORMATION: 

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 

specific schedule, the Secretary of the 

Department Health and Human Services 

(HHS),1 after consultation with the 

Attorney General, shall 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.2 In the event 

that the Secretary of HHS did not 

consult with the Attorney General, and 


lotter on DSK11XQN23PROD with RULES1