Federal Register / Vol. 87, No. 110 / Wednesday, June 8, 2022 / Rules and Regulations 34775 

in accordance with the Accomplishment 

Instructions, paragraph A.4., in Viking SB 

V6/0063, Revision A, and the 

Accomplishment Instructions, Sections A 

through C, in Viking DHC–6 Twin Otter 

Technical Bulletin No. V6/00155, Revision 

NC, dated September 14, 2020 (Viking TB 

V6/00155, Revision NC). 

(ii) If there is no binding and no restriction, 

before further flight, remove each affected 

FCU push rod assembly, clean the push rod 

ends, and inspect each affected FCU push 

rod assembly for corrosion and condition of 

the lubricant. Pay particular attention to the 

bearing ball and race. 

(A) If there is no corrosion and the 

lubricant color and texture is normal, before 

further flight, lubricate each affected FCU 

push rod assembly in accordance with the 

Accomplishment Instructions, Section C, in 

Viking SB V6/0063, Revision A. 

(B) If there is corrosion or if the lubricant 

is abnormal in color (too dark) or texture (too 

sticky), before further flight, remove both 

affected FCU push rod assemblies from 

service and install serviceable FCU push rod 

assemblies in accordance with the 

Accomplishment Instructions, paragraph A.4, 

in Viking SB V6/0063, Revision A, and the 

Accomplishment Instructions, Sections A 

through C, in Viking TB V6/00155, Revision 

NC. 

(2) Repeat the requirements of this AD as 

follows until both affected FCU push rod 

assemblies are replaced. 

(i) Test and lubrication: At intervals not to 

exceed 125 hours TIS or before further flight 

anytime the airplane has not been operated 

for a period of 30 days, whichever occurs 

first. 

(ii) Inspection: At intervals not to exceed 

1,500 hours TIS. 

(3) As of the effective date of this AD, do 

not install an affected FCU push rod 

assembly on any airplane. 

(i) Credit for Previous Actions 

You may take credit for the test, 

inspection, replacement, and lubrication 

required by paragraphs (h)(1) and (2) of this 

AD if you performed those actions before the 

effective date of this AD using Viking DHC– 

6 Twin Otter Service Bulletin No. V6/0063, 

Revision NC, dated June 7, 2019. 

(j) Alternative Methods of Compliance 

(AMOCs) 

(1) The Manager, New York ACO Branch, 

FAA, has the authority to approve AMOCs 

for this AD, if requested using the procedures 

found in 14 CFR 39.19. In accordance with 

14 CFR 39.19, send your request to your 

principal inspector or local Flight Standards 

District Office, as appropriate. If sending 

information directly to the manager of the 

certification office, send it to the attention of 

the person identified in paragraph (k)(1) of 

this AD. 

(2) Before using any approved AMOC, 

notify your appropriate principal inspector, 

or lacking a principal inspector, the manager 

of the local flight standards district office/ 

certificate holding district office. 

(k) Related Information 

(1) For more information about this AD, 

contact Elizabeth Dowling, Aviation Safety 

Engineer, New York ACO Branch, FAA, 1600 

Stewart Avenue, Suite 410, Westbury, NY 

11590; phone: (516) 228–7300; email: 

elizabeth.m.dowling@faa.gov. 

(2) Refer to Transport Canada AD CF– 

2021–42, dated November 26, 2021, for more 

information. You may examine the Transport 

Canada AD in the AD docket at https://

www.regulations.gov by searching for and 

locating it in Docket No. FAA–2022–0284. 

(3) Service information identified in this 

AD that is not incorporated by reference is 

available at the addresses specified in 

paragraphs (l)(3) and (4) of this AD. 

(l) Material Incorporated by Reference 

(1) The Director of the Federal Register 

approved the incorporation by reference 

(IBR) of the service information listed in this 

paragraph under 5 U.S.C. 552(a) and 1 CFR 

part 51. 

(2) You must use this service information 

as applicable to do the actions required by 

this AD, unless the AD specifies otherwise. 

(i) Viking DHC–6 Twin Otter Service 

Bulletin No. V6/0063, Revision A, dated 

February 1, 2021. 

(ii) Viking DHC–6 Twin Otter Technical 

Bulletin No. V6/00155, Revision NC, dated 

September 14, 2020. 

(3) For service information identified in 

this AD, contact Viking Air Ltd., 1959 de 

Havilland Way, Sidney British Columbia, 

Canada V8L 5V5; phone: (800) 663–8444; 

email: continuing.airworthiness@

vikingair.com; website: https://

www.vikingair.com. 

(4) You may view this service information 

at the FAA, Airworthiness Products Section, 

Operational Safety Branch, 901 Locust, 

Kansas City, MO 64106. For information on 

the availability of this material at the FAA, 

call (817) 222–5110. 

(5) You may view this service information 

that is incorporated by reference at the 

National Archives and Records 

Administration (NARA). For information on 

the availability of this material at NARA, 

email: fr.inspection@nara.gov, or go to: 

https://www.archives.gov/federal-register/cfr/

ibr-locations.html. 

Issued on May 24, 2022. 

Gaetano A. Sciortino, 

Deputy Director for Strategic Initiatives, 

Compliance & Airworthiness Division, 

Aircraft Certification Service. 

[FR Doc. 2022–12184 Filed 6–7–22; 8:45 am] 

BILLING CODE 4910–13–P 

DEPARTMENT OF HOMELAND 

SECURITY 

U.S. Customs and Border Protection 

DEPARTMENT OF THE TREASURY 

19 CFR Part 12 

[CBP Dec. 22–11] 

RIN 1515–AE73 

Extension of Import Restrictions 

Imposed on Certain Archaeological 

Artifacts and Ethnological Material 

From Peru 

AGENCY: U.S. Customs and Border 

Protection, Department of Homeland 

Security; Department of the Treasury. 

ACTION: Final rule. 

SUMMARY: This document amends the 

U.S. Customs and Border Protection 

(CBP) regulations to reflect an extension 

of import restrictions on certain 

categories of archaeological artifacts and 

ethnological material of the Republic of 

Peru. The restrictions, which were 

originally imposed by Treasury Decision 

(T.D.) 97–50 and last extended by CBP 

Decision (CBP Dec.) 17–03, are due to 

expire on June 9, 2022, unless extended. 

The Assistant Secretary for Educational 

and Cultural Affairs, United States 

Department of State, has made the 

requisite determinations for extending 

the import restrictions that previously 

existed and no cause for suspension 

exists. Pursuant to the exchange of 

diplomatic notes to extend the 

agreement, the import restrictions will 

remain in effect for an additional five 

years, and the CBP regulations are being 

amended to reflect this further 

extension through June 8, 2027. CBP– 

Dec. 17–03 contains the Designated List 

of archeological artifacts and 

ethnological material from Peru to 

which the restrictions apply. 

DATES: Effective on June 9, 2022. 

FOR FURTHER INFORMATION CONTACT: For 

legal aspects, W. Richmond Beevers, 

Chief, Cargo Security, Carriers and 

Restricted Merchandise Branch, 

Regulations and Rulings, Office of 

Trade, (202) 325–0084, ototrrculturalproperty@cbp.dhs.gov. For 

operational aspects, Julie L. Stoeber, 

Chief, 1USG Branch, Trade Policy and 

Programs, Office of Trade, (202) 945– 

7064, 1USGBranch@cbp.dhs.gov. 

SUPPLEMENTARY INFORMATION: 

Background 

Pursuant to the Convention on 

Cultural Property Implementation Act, 

Public Law 97–446, 19 U.S.C. 2601 et 

seq., which implements the 1970 United 


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34776 Federal Register / Vol. 87, No. 110 / Wednesday, June 8, 2022 / Rules and Regulations 

Nations Educational, Scientific and 

Cultural Organization (UNESCO) 

Convention on the Means of Prohibiting 

and Preventing the Illicit Import, Export 

and Transfer of Ownership of Cultural 

Property (823 U.N.T.S. 231 (1972)), the 

United States entered into a bilateral 

agreement with the Republic of Peru 

(Peru) on June 9, 1997, concerning the 

imposition of import restrictions on 

archaeological material from the PreHispanic cultures and certain 

ethnological material from the Colonial 

period of Peru (the Memorandum of 

Understanding (MOU) between the 

United States of America and the 

Republic of Peru). 

On June 11, 1997, the U.S. Customs 

Service (U.S. Customs and Border 

Protection’s predecessor agency) 

published Treasury Decision (T.D.) 97– 

50 in the Federal Register (62 FR 

31713), which amended § 12.104g(a) of 

title 19 of the Code of Federal 

Regulations (19 CFR 12.104g(a)) to 

reflect the imposition of these 

restrictions and included a list 

designating the types of archaeological 

and ethnological material covered by 

the restrictions. These restrictions 

continued the protection of 

archaeological material from the Sipa ́n 

Archaeological Region forming part of 

the remains of the Moche culture that 

were first subject to emergency import 

restrictions on May 7, 1990 (T.D. 90– 

37), which were extended on June 27, 

1994 (T.D. 94–54). 

Import restrictions listed at 19 CFR 

12.104g(a) are effective for no more than 

five years beginning on the date on 

which the agreement enters into force 

with respect to the United States. This 

period may be extended for additional 

periods of no more than five years if it 

is determined that the factors which 

justified the agreement still pertain and 

no cause for suspension of the 

agreement exists. See 19 CFR 12.104g(a). 

Since the initial final rule was 

published on June 11, 1997, the import 

restrictions were subsequently extended 

four (4) times. First, on June 6, 2002, 

following the exchange of diplomatic 

notes, the former U.S. Customs Service 

published a final rule (T.D. 02–30) in 

the Federal Register (67 FR 38877) to 

extend the import restrictions for a 

period of five years. Second, on June 6, 

2007, following the exchange of 

diplomatic notes, CBP published a final 

rule (CBP Dec. 07–27) in the Federal 

Register (72 FR 31176) to extend the 

import restrictions for an additional 

five-year period. Third, on June 7, 2012, 

following the exchange of diplomatic 

notes, CBP published a final rule (CBP 

Dec. 12–11) in the Federal Register (77 

FR 33624) to extend the import 

restrictions for an additional five-year 

period. Fourth and lastly, on June 7, 

2017, following the exchange of 

diplomatic notes, CBP published a final 

rule (CBP Dec. 17–03) in the Federal 

Register (82 FR 26340) to extend the 

import restrictions for an additional 

five-year period through June 8, 2022. 

On September 13, 2021, the United 

States Department of State proposed in 

the Federal Register (86 FR 50931) to 

extend the MOU between the United 

States and Peru concerning the import 

restrictions on certain categories of 

archaeological and ethnological material 

from Peru. On March 15, 2022, after 

consultation with and recommendations 

by the Cultural Property Advisory 

Committee, the Assistant Secretary for 

Educational and Cultural Affairs, United 

States Department of State, determined 

that the cultural heritage of Peru 

continues to be in jeopardy from pillage 

of certain archeological and ethnological 

material, and that the import restrictions 

should be extended for an additional 

five years. Pursuant to the exchange of 

diplomatic notes to extend the 

agreement, the import restrictions will 

remain in effect for an additional five 

years, and the CBP regulations are being 

amended to reflect this further 

extension through June 8, 2027. 

Accordingly, CBP is amending 19 CFR 

12.104g(a) to reflect the extension of the 

import restrictions. The restrictions on 

the importation of archaeological 

artifacts and ethnological material are to 

continue to be in effect through June 8, 

2027. Importation of such material from 

Peru continues to be restricted through 

that date unless the conditions set forth 

in 19 U.S.C. 2606 and 19 CFR 12.104c 

are met. 

The Designated List and additional 

information may also be found at the 

following website address: https://

eca.state.gov/cultural-heritage-center/ 

cultural-property-advisory-committee/ 

current-import-restrictions by selecting 

the material for ‘‘Peru.’’ 

Inapplicability of Notice and Delayed 

Effective Date 

This amendment involves a foreign 

affairs function of the United States and 

is, therefore, being made without notice 

or public procedure under 5 U.S.C. 

553(a)(1). For the same reason, a 

delayed effective date is not required 

under 5 U.S.C. 553(d)(3). 

Regulatory Flexibility Act 

Because no notice of proposed 

rulemaking is required, the provisions 

of the Regulatory Flexibility Act (5 

U.S.C. 601 et seq.) do not apply. 

Executive Order 12866 

CBP has determined that this 

document is not a regulation or rule 

subject to the provisions of Executive 

Order 12866 because it pertains to a 

foreign affairs function of the United 

States, as described above, and therefore 

is specifically exempted by section 

3(d)(2) of Executive Order 12866. 

Signing Authority 

This regulation is being issued in 

accordance with 19 CFR 0.1(a)(1), 

pertaining to the Secretary of the 

Treasury’s authority (or that of his/her 

delegate) to approve regulations related 

to customs revenue functions. 

Chris Magnus, the Commissioner of 

CBP, having reviewed and approved 

this document, has delegated the 

authority to electronically sign this 

document to Robert F. Altneu, who is 

the Director of the Regulations and 

Disclosure Law Division for CBP, for 

purposes of publication in the Federal 

Register. 

List of Subjects in 19 CFR Part 12 

Cultural property, Customs duties and 

inspection, Imports, Prohibited 

merchandise, Reporting and 

recordkeeping requirements. 

Amendment to the CBP Regulations 

For the reasons set forth above, part 

12 of title 19 of the Code of Federal 

Regulations (19 CFR part 12), is 

amended as set forth below: 

PART 12—SPECIAL CLASSES OF 

MERCHANDISE 

■ 1. The general authority citation for 

part 12 and the specific authority 

citation for § 12.104g continue to read as 

follows: 

Authority: 5 U.S.C. 301; 19 U.S.C. 66, 1202 

(General Note 3(i), Harmonized Tariff 

Schedule of the United States (HTSUS)), 

1624. 

* * * * * 

Sections 12.104 through 12.104i also 

issued under 19 U.S.C. 2612; 

* * * * * 

■ 2. In § 12.104g, amend the table in 

paragraph (a) by revising the entry for 

Peru to read as follows: 

§ 12.104g Specific items or categories 

designated by agreements or emergency 

actions. 

(a) * * * 


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Federal Register / Vol. 87, No. 110 / Wednesday, June 8, 2022 / Rules and Regulations 34777 

State party Cultural property Decision No. 

*******

Peru ......................................................... Archaeological artifacts and ethnological material from Peru ................................. CBP Dec. 22–11. 

*******

* * * * * 

Robert F. Altneu, 

Director, Regulations & Disclosure Law 

Division, Regulations & Rulings, Office of 

Trade, U.S. Customs and Border Protection. 

Approved: 

Thomas C. West Jr., 

Deputy Assistant Secretary of the Treasury 

for Tax Policy. 

[FR Doc. 2022–12299 Filed 6–7–22; 8:45 am] 

BILLING CODE 9111–14–P 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Food and Drug Administration 

21 CFR Part 870 

[Docket No. FDA–2021–N–0600] 

Medical Devices; Cardiovascular 

Devices; Classification of the 

Intravascular Bleed Monitor 

AGENCY: Food and Drug Administration, 

HHS. 

ACTION: Final amendment; final order. 

SUMMARY: The Food and Drug 

Administration (FDA or we) is 

classifying the intravascular bleed 

monitor 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 intravascular bleed monitor’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. 

DATES: This order is effective June 8, 

2022. The classification was applicable 

on March 1, 2019. 

FOR FURTHER INFORMATION CONTACT: LT 

Stephen Browning, Center for Devices 

and Radiological Health, Food and Drug 

Administration, 10903 New Hampshire 

Ave., Bldg. 66, Rm. 2106, Silver Spring, 

MD 20993–0002, 240–402–5241, 

Stephen.Browning@fda.hhs.gov. 

SUPPLEMENTARY INFORMATION: 

I. Background 

Upon request, FDA has classified the 

intravascular bleed monitor 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 (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 established the first procedure 

for De Novo classification (Pub. L. 105– 

115). Section 607 of the Food and Drug 

Administration Safety and Innovation 

Act modified the De Novo application 

process by adding a second procedure 

(Pub. L. 112–144). 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 21 U.S.C. 360c(f)(2)(B)(i)). 

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 21 U.S.C. 360c(i), defining 

‘‘substantial equivalence’’). Instead, 

sponsors can use the less-burdensome 

510(k) process, when necessary, to 

market their device. 

II. De Novo Classification 

On April 23, 2018, Saranas, Inc. 

submitted a request for De Novo 

classification of the Early Bird Bleed 

Monitoring System. 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 


khammond on DSKJM1Z7X2PROD with RULES