Federal Register / Vol. 87, No. 105 / Wednesday, June 1, 2022 / Rules and Regulations 32987 

PART 743—SPECIAL REPORTING AND 

NOTIFICATION 

■ 3. The authority citation for 15 CFR 

part 743 is revised to read as follows: 

Authority: 50 U.S.C. 4801–4852; 50 U.S.C. 

4601 et seq.; 50 U.S.C. 1701 et seq.; E.O. 

13222, 66 FR 44025, 3 CFR, 2001 Comp., p. 

783; E.O. 13637, 78 FR 16129, 3 CFR, 2014 

Comp., p. 223; 78 FR 16129. 

■ 4. Section 743.5(e) is amended by 

removing ‘‘bis.compliance@bis.doc.gov’’ 

and adding in its place ‘‘mcd_

compliance@bis.doc.gov.’’ 

■ 5. Section 743.6 is added to read as 

follows: 

§ 743.6 Prior notifications to Congress of 

exports of certain semiautomatic firearms. 

(a) General requirement. Applications 

to export semiautomatic firearms 

controlled by ECCN 0A501.a will be 

notified to Congress as provided in this 

section before licenses for such items 

are issued, except as specified in 

paragraphs (a)(1) to (2) of this section. 

(1) Exports of semiautomatic firearms 

controlled by ECCN 0A501.a to 

personnel and agencies of the U.S. 

Government under License Exception 

GOV (§ 740.11(b) of the EAR) do not 

require such notification. 

(2) Exports of semiautomatic firearms 

controlled by ECCN 0A501.a for official 

use by an agency of NATO do not 

require such notification. 

(b) Notification criteria. Unless 

excluded in paragraphs (a)(1) to (2) of 

this section, BIS will notify Congress 

prior to issuing a license authorizing the 

export of items to Mexico, South Africa, 

or Turkey or any other country not 

listed in Country Group A:5 or A:6 (see 

supplement no.1 to part 740 of the EAR) 

if the items are sold under a contract or 

are otherwise part of an export 

transaction that includes $4,000,000 or 

more of semiautomatic firearms 

controlled by ECCN 0A501.a. 

(c) License application information. In 

addition to information required on the 

application, the exporter must include a 

copy of the signed contract or, if there 

is no contract, a written explanation 

from the applicant (including a 

statement of the value of the firearms 

controlled by ECCN 0A501.a to be 

exported) for any proposed export 

described in paragraph (b) of this 

section. License applications for 

semiautomatic firearms controlled by 

ECCN 0A501.a may include other 

nonautomatic firearms, shotguns, other 

0x5zz items, or other items subject to 

the EAR, but the applicant must clearly 

identify the semiautomatic firearms 

controlled by ECCN 0A501.a. The 

applicant clearly distinguishing the 

semiautomatic firearms controlled by 

ECCN 0A501.a from any other items on 

the license application will assist BIS in 

assessing whether the license 

application requires congressional 

notification under this section and 

identifying the information that will 

need to be reported to Congress. Any 

activity intended to circumvent 

notification requirements is prohibited. 

Such devices include, but are not 

limited to, the splitting or structuring of 

contracts to avoid exceeding applicable 

notification dollar value limits 

described in paragraph (a) of this 

section. 

(d) Additional information. For 

questions on this section, you may 

contact the Nuclear and Missile 

Technology Controls Division, Guns and 

Ammunition licensing group at 

firearmsCN@bis.doc.gov. 

PART 748—APPLICATIONS 

(CLASSIFICATION, ADVISORY, AND 

LICENSE) AND DOCUMENTATION 

■ 6. The authority citation for 15 CFR 

part 748 is revised to read as follows: 

Authority: 50 U.S.C. 4801–4852; 50 U.S.C. 

4601 et seq.; 50 U.S.C. 1701 et seq.; E.O. 

13026, 61 FR 58767, 3 CFR, 1996 Comp., p. 

228; E.O. 13222, 66 FR 44025, 3 CFR, 2001 

Comp., p. 783; Notice of August 6, 2021, 86 

FR 43901 (August 10, 2021). 

■ 7. Supplement No. 2 to part 748 

(Unique Application and Submission 

Requirements) is amended by adding 

paragraphs (aa) and (bb) to read as 

follows: 

Supplement No. 2 to Part 748—Unique 

Application and Submission 

Requirements 

* * * * * 

(aa) ‘‘600 Series Major Defense 

Equipment.’’ For license applications 

that require prior notifications to 

Congress of exports of ‘‘600 series major 

defense equipment’’ pursuant to § 743.5, 

the exporter must include a copy of the 

signed contract (including a statement 

of the value of the ‘‘600 Series Major 

Defense Equipment’’ to be exported 

under the contract). (See § 743.5(d) of 

the EAR) 

(bb) Semiautomatic firearms 

controlled under ECCN 0A501.a. For 

export license applications that require 

prior notifications to congress of exports 

of semiautomatic firearms controlled 

under ECCN 0A501.a under the criteria 

of § 743.6, the exporter must include a 

copy of the signed contract or, if there 

is no contract, a written explanation 

from the applicant (including a 

statement of the value of the firearms 

controlled by ECCN 0A501.a to be 

exported). License applications for 

semiautomatic firearms controlled by 

ECCN 0A501.a may include other 

nonautomatic firearms, shotguns, other 

0x5zz items, or other items subject to 

the EAR, but the applicant must clearly 

identify the semiautomatic firearms 

controlled by ECCN 0A501.a. 

Thea D. Rozman Kendler, 

Assistant Secretary for Export 

Administration. 

[FR Doc. 2022–11761 Filed 5–31–22; 8:45 am] 

BILLING CODE 3510–33–P 

DEPARTMENT OF COMMERCE 

Bureau of Industry and Security 

15 CFR Part 744 

Control Policy: End-User and End-Use 

Based 

CFR Correction 

This rule is being published by the 

Office of the Federal Register to correct 

an editorial or technical error that 

appeared in the most recent annual 

revision of the Code of Federal 

Regulations. 

■ In Title 15 of the Code of Federal 

Regulations, Parts 300 to 799, revised as 

of January 1, 2022, in supplement no. 4 

to part 744, in the table under 

‘‘RUSSIA’’, revise the entry for 

‘‘Kaliningradnefteprodukt OOO’’ to read 

as follows: 

SUPPLEMENT NO. 4 TO PART 744—ENTITY LIST

Country Entity License 

requirement 

License 

review policy 

Federal Register 

citation 

*******

RUSSIA ............ ******


jspears on DSK121TN23PROD with RULES1
32988 Federal Register / Vol. 87, No. 105 / Wednesday, June 1, 2022 / Rules and Regulations 

SUPPLEMENT NO. 4 TO PART 744—ENTITY LIST—Continued 

Country Entity License 

requirement 

License 

review policy 

Federal Register 

citation 

Kaliningradnefteprodukt OOO, a.k.a., 

the following three aliases: 

—Kaliningradnefteprodukt LLC; 

—Limited Liability Company 

Kaliningradnefteproduct; and 

—LLC Kaliningradnefteproduct 

For all items subject to 

the EAR when used in 

projects specified in 

§ 746.5 of the EAR.

Presumption of denial ...... 83 FR 6952, 2/16/18. 83 

FR 12479, 3/22/18. 

22–b Komsomolskaya Ulitsa, Central 

District, Kaliningrad, Russia. 

*******

[FR Doc. 2022–11614 Filed 5–31–22; 8:45 am] 

BILLING CODE 099–10–P 

CONSUMER PRODUCT SAFETY 

COMMISSION 

16 CFR Part 1225 

Safety Standard for Hand-Held Infant 

Carriers 

CFR Correction 

This rule is being published by the 

Office of the Federal Register to correct 

an editorial or technical error that 

appeared in the most recent annual 

revision of the Code of Federal 

Regulations. 

■ In Title 16 of the Code of Federal 

Regulations, Part 1000 to End, revised as 

of January 1, 2022, in § 1225.2, add 

‘‘email: cpsc-os@cpsc.gov,’’ in the fifth 

sentence after the telephone number 

‘‘301–504–7479’’. 

[FR Doc. 2022–11615 Filed 5–31–22; 8:45 am] 

BILLING CODE 0099–10–P 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Food and Drug Administration 

21 CFR Part 870 

[Docket No. FDA–2022–N–0713] 

Medical Devices; Cardiovascular 

Devices; Classification of the Coronary 

Artery Disease Risk Indicator Using 

Acoustic Heart Signals 

AGENCY: Food and Drug Administration, 

HHS. 

ACTION: Final amendment; final order. 

SUMMARY: The Food and Drug 

Administration (FDA or we) is 

classifying the coronary artery disease 

risk indicator using acoustic heart 

signals 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 coronary artery disease risk 

indicator using acoustic heart signals’ 

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. 

DATES: This order is effective June 1, 

2022. The classification was applicable 

on November 24, 2020. 

FOR FURTHER INFORMATION CONTACT: 

Kimberly Crowley, Center for Devices 

and Radiological Health, Food and Drug 

Administration, 10903 New Hampshire 

Ave., Bldg. 66, Rm. 2531, Silver Spring, 

MD, 20993–0002, 301–796–6017, 

Kimberly.Crowley@fda.hhs.gov. 

SUPPLEMENTARY INFORMATION: 

I. Background 

Upon request, FDA has classified the 

coronary artery disease risk indicator 

using acoustic heart signals 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 


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