50070 Federal Register / Vol. 82, No. 208 / Monday, October 30, 2017 / Rules and Regulations 

DEPARTMENT OF HOMELAND 

SECURITY 

U.S. Customs and Border Protection 

DEPARTMENT OF THE TREASURY 

19 CFR Part 12 

[CBP Dec. 17–15] 

RIN 1515–AE27 

Removing the Prohibition on the 

Importation of Jadeite or Rubies Mined 

or Extracted From Burma, and Articles 

of Jewelry Containing Jadeite or 

Rubies Mined or Extracted From 

Burma 

AGENCY: U.S. Customs and Border 

Protection, Department of Homeland 

Security; Department of Treasury. 

ACTION: Final rule. 

SUMMARY: This document amends the 

U.S. Customs and Border Protection 

(CBP) regulations to remove the 

provision relating to the prohibition on 

the importation of jadeite or rubies 

mined or extracted from Burma, and 

articles of jewelry containing jadeite or 

rubies mined or extracted from Burma. 

This reflects the termination of all 

Burmese sanctions by Executive Order 

13742, of October 7, 2016. 

DATES: This final rule is effective on 

October 30, 2017. 

FOR FURTHER INFORMATION CONTACT: 

Daniel Collier, Partner Government 

Agency Branch, Trade Policy and 

Programs, Office of Trade, (202) 863– 

6225, Daniel.Collier@cbp.dhs.gov; or 

William Scopa, Branch Chief, Partner 

Government Agency Branch, Trade 

Policy and Programs, Office of Trade, 

(202) 863–6554, William.R.Scopa@

cbp.dhs.gov. 

SUPPLEMENTARY INFORMATION: 

I. Background 

On July 28, 2003, the President signed 

into law the Burmese Freedom and 

Democracy Act of 2003 (Pub. L. 108–61) 

(the ‘‘BFDA’’) to sanction the military 

junta then ruling Burma. Among other 

provisions, the BFDA required the 

imposition, subject to annual renewal, 

of a ban on the importation into the 

United States of any article that is a 

product of Burma. To implement the 

BFDA, the President issued Executive 

Order (‘‘E.O.’’) 13310 (68 FR 44853, July 

30, 2003), which prohibited, among 

other things, the importation into the 

United States of any article that is a 

product of Burma. 

On July 29, 2008, the President signed 

into law the Tom Lantos Block Burmese 

JADE (Junta’s Anti-Democratic Efforts) 

Act of 2008 (Pub. L. 110–286) (the 

‘‘JADE Act’’), which, among other 

things, amended the BFDA to require a 

prohibition on the importation into the 

United States of jadeite or rubies mined 

or extracted from Burma and articles of 

jewelry containing such jadeite or 

rubies. Section 12.151 of the CBP 

regulations (Title 19, Code of Federal 

Regulations (‘‘CFR’’) section 12.151) 

reflects this prohibition on the 

importation of jadeite or rubies mined 

or extracted from Burma and articles of 

jewelry containing such jadeite or 

rubies. 

The BFDA, as amended by the JADE 

Act, required annual renewal, which 

did not occur in 2013. As a result, the 

prohibition on the importation of jadeite 

or rubies mined or extracted from 

Burma and articles of jewelry containing 

jadeite or rubies mined or extracted 

from Burma expired on July 28, 2013. 

On August 6, 2013, the President signed 

E.O. 13651, titled ‘‘Prohibiting Certain 

Imports of Burmese Jadeite and Rubies’’ 

(78 FR 48793), which revoked the 

sections of E.O. 13310 imposing a 

prohibition on the importation into the 

United States of any article that is a 

product of Burma. As a result, there was 

no longer a general ban on importing 

into the United States any article that is 

a product of Burma; however, the 

specific ban of jadeite and rubies mined 

or extracted from Burma as well as 

articles of jewelry containing jadeite or 

rubies mined or extracted from Burma 

was reinstituted by E.O. 13651. 

Consequently, on August 23, 2016, CBP 

published a final rule in the Federal 

Register (81 FR 57456) amending the 

CBP regulations to update the relevant 

provisions to reflect the import 

prohibitions set forth in E.O. 13651. 

II. Termination of the Burmese 

Sanctions 

On October 7, 2016, the President 

signed E.O. 13742, titled ‘‘Termination 

of Emergency With Respect to the 

Actions and Policies of the Government 

of Burma’’ (81 FR 70593), which 

revoked, among others, E.O. 13310 and 

13651. The President found that the 

situation that gave rise to the 

declaration of a national emergency 

with respect to the actions and policies 

of the Government of Burma has been 

significantly altered by Burma’s 

substantial advances in promoting 

democracy, including historic elections 

that resulted in the formation of a 

democratically elected, civilian-led 

government; the release of many 

political prisoners; and greater 

enjoyment of human rights and 

fundamental freedoms, including 

freedom of expression and freedom of 

association and peaceful assembly. As a 

result, President Obama revoked all the 

Burmese sanctions. This was 

accomplished by revoking, among 

others, E.O. 13651, which prohibited the 

importation of any jadeite or rubies 

mined or extracted from Burma as well 

as any articles of jewelry containing 

jadeite or rubies mined or extracted 

from Burma. As of October 7, 2016, CBP 

is no longer enforcing this import 

prohibition. To reflect this, CBP is 

removing the relevant provision, 19 CFR 

12.151, from the CBP regulations. 

III. Statutory and Regulatory 

Requirements 

A. Inapplicability of Public Notice and 

Delayed Effective Date Requirements 

Under section 553 of the 

Administrative Procedure Act (APA) (5 

U.S.C. 553), rulemaking generally 

requires prior notice and comment, and 

a 30-day delayed effective date, subject 

to specified exceptions. This document 

amends the regulations to remove 19 

CFR 12.151 to reflect Executive Order 

13742 of October 7, 2016, which 

terminated the import prohibitions on 

Burmese articles. Since this document 

removes a regulation that is no longer 

applicable or enforced by CBP in light 

of the Executive Order, CBP has 

determined it is a nondiscretionary 

action and that, pursuant to the 

provisions of 5 U.S.C. 553(b)(B), prior 

public notice and comment procedures 

on this regulation are impracticable, 

unnecessary, and contrary to the public 

interest and that there is good cause for 

this rule to become effective 

immediately upon publication. For 

these reasons, pursuant to the provision 

of 5 U.S.C. 553(d)(3), CBP finds that 

there is good cause for dispensing with 

a delayed effective date. 

B. Executive Orders 13563 and 12866: 

Regulatory Planning and Review 

Executive Orders 13563 and 12866 

direct agencies to assess the costs and 

benefits of available regulatory 

alternatives and, if regulation is 

necessary, to select regulatory 

approaches that maximize net benefits 

(including potential economic, 

environmental, public health and safety 

effects, distributive impacts, and 

equity). Executive Order 13563 

emphasizes the importance of 

quantifying both costs and benefits, of 

reducing costs, of harmonizing rules, 

and of promoting flexibility. This rule is 

not a ‘‘significant regulatory action,’’ 

under section 3(f) of Executive Order 

12866. Accordingly, the Office of 

Management and Budget has not 

reviewed this regulation. 


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Federal Register / Vol. 82, No. 208 / Monday, October 30, 2017 / Rules and Regulations 50071 

C. Regulatory Flexibility Act 

The Regulatory Flexibility Act (5 

U.S.C. 601 et seq.), as amended by the 

Small Business Regulatory Enforcement 

and Fairness Act of 1996, requires an 

agency to prepare and make available to 

the public a regulatory flexibility 

analysis that describes the effect of a 

proposed rule on small entities (i.e., 

small businesses, small organizations, 

and small governmental jurisdictions) 

when the agency is required to publish 

a general notice of proposed rulemaking 

for a rule. As a notice of proposed 

rulemaking is not necessary for this 

rule, CBP is not required to prepare a 

regulatory flexibility analysis for this 

rule. 

D. 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 

delegate) to approve regulations related 

to certain customs revenue functions. 

List of Subjects in 19 CFR Part 12 

Customs duties and inspection, 

Reporting and recordkeeping 

requirements. 

Amendments to the Regulations 

For the reasons set forth in the 

preamble, 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 continues 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. 

* * * * * 

■ 2. The specific authority citation for 

§ 12.151 is removed. 

§ 12.151 [Removed and Reserved] 

■ 3. Remove and reserve § 12.151. 

Dated: October 25, 2017. 

Kevin K. McAleenan, 

Acting Commissioner, U.S. Customs and 

Border Protection. 

Approved: 

Timothy E. Skud, 

Deputy Assistant Secretary of the Treasury. 

[FR Doc. 2017–23560 Filed 10–27–17; 8:45 am] 

BILLING CODE 9111–14–P 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Food and Drug Administration 

21 CFR Part 862 

[Docket No. FDA–2017–N–5685] 

Medical Devices; Clinical Chemistry 

and Clinical Toxicology Devices; 

Classification of the Acute Kidney 

Injury Test System 

AGENCY: Food and Drug Administration, 

HHS. 

ACTION: Final order. 

SUMMARY: The Food and Drug 

Administration (FDA or we) is 

classifying the acute kidney injury test 

system 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 acute kidney injury test system’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, 

in part by reducing regulatory burdens. 

DATES: This order is effective October 

30, 2017. The classification was 

applicable on September 5, 2014. 

FOR FURTHER INFORMATION CONTACT: Seth 

Olson, Center for Devices and 

Radiological Health, Food and Drug 

Administration, 10903 New Hampshire 

Ave., Bldg. 66, Rm. 4561, Silver Spring, 

MD 20993–0002, 301–796–4364, 

Jeremy.Olson@fda.hhs.gov. 

SUPPLEMENTARY INFORMATION: 

I. Background 

Upon request, FDA has classified the 

acute kidney injury test system 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 reducing 

regulatory burdens 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 (the 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 to a 

predicate device that does not require 

premarket approval (see 21 U.S.C. 

360c(i)). We determine whether a new 

device is substantially equivalent to a 

predicate by means of the procedures 

for premarket notification under section 

510(k) of the FD&C Act and part 807 (21 

U.S.C. 360(k) and 21 CFR part 807, 

respectively). 

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. 

We believe this De Novo classification 

will enhance patients’ access to 

beneficial innovation, in part by 

reducing regulatory burdens. When FDA 


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