82 FR 50070 - 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

DEPARTMENT OF HOMELAND SECURITY
U.S. Customs and Border Protection
DEPARTMENT OF THE TREASURY

Federal Register Volume 82, Issue 208 (October 30, 2017)

Page Range		50070-50071
FR Document		2017-23560

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.

Federal Register, Volume 82 Issue 208 (Monday, October 30, 2017)

[Federal Register Volume 82, Number 208 (Monday, October 30, 2017)]
[Rules and Regulations]
[Pages 50070-50071]
From the Federal Register Online  [www.thefederalregister.org]
[FR Doc No: 2017-23560]



[[Page 50070]]

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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, [email protected]; or William Scopa, Branch Chief, 
Partner Government Agency Branch, Trade Policy and Programs, Office of 
Trade, (202) 863-6554, [email protected].

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.

[[Page 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

0
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.
* * * * *

0
2. The specific authority citation for Sec.  12.151 is removed.


Sec.  12.151   [Removed and Reserved]

0
3. Remove and reserve Sec.  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

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

DEPARTMENT OF HOMELAND Act of 2008 (Pub. L. 110–286) (the association and peaceful assembly. As a
SECURITY ‘‘JADE Act’’), which, among other result, President Obama revoked all the
things, amended the BFDA to require a Burmese sanctions. This was
U.S. Customs and Border Protection prohibition on the importation into the accomplished by revoking, among
United States of jadeite or rubies mined others, E.O. 13651, which prohibited the
DEPARTMENT OF THE TREASURY or extracted from Burma and articles of importation of any jadeite or rubies
jewelry containing such jadeite or mined or extracted from Burma as well
19 CFR Part 12 rubies. Section 12.151 of the CBP as any articles of jewelry containing
[CBP Dec. 17–15]
regulations (Title 19, Code of Federal jadeite or rubies mined or extracted
Regulations (‘‘CFR’’) section 12.151) from Burma. As of October 7, 2016, CBP
RIN 1515–AE27 reflects this prohibition on the is no longer enforcing this import
importation of jadeite or rubies mined prohibition. To reflect this, CBP is
Removing the Prohibition on the or extracted from Burma and articles of removing the relevant provision, 19 CFR
Importation of Jadeite or Rubies Mined jewelry containing such jadeite or 12.151, from the CBP regulations.
or Extracted From Burma, and Articles rubies.
of Jewelry Containing Jadeite or The BFDA, as amended by the JADE III. Statutory and Regulatory
Rubies Mined or Extracted From Act, required annual renewal, which Requirements
Burma did not occur in 2013. As a result, the A. Inapplicability of Public Notice and
AGENCY: U.S. Customs and Border prohibition on the importation of jadeite Delayed Effective Date Requirements
Protection, Department of Homeland or rubies mined or extracted from
Burma and articles of jewelry containing Under section 553 of the
Security; Department of Treasury. Administrative Procedure Act (APA) (5
jadeite or rubies mined or extracted
ACTION: Final rule. U.S.C. 553), rulemaking generally
from Burma expired on July 28, 2013.
On August 6, 2013, the President signed requires prior notice and comment, and
SUMMARY: This document amends the
E.O. 13651, titled ‘‘Prohibiting Certain a 30-day delayed effective date, subject
U.S. Customs and Border Protection
Imports of Burmese Jadeite and Rubies’’ to specified exceptions. This document
(CBP) regulations to remove the
(78 FR 48793), which revoked the amends the regulations to remove 19
provision relating to the prohibition on
sections of E.O. 13310 imposing a CFR 12.151 to reflect Executive Order
the importation of jadeite or rubies
prohibition on the importation into the 13742 of October 7, 2016, which
mined or extracted from Burma, and
United States of any article that is a terminated the import prohibitions on
articles of jewelry containing jadeite or
product of Burma. As a result, there was Burmese articles. Since this document
rubies mined or extracted from Burma.
no longer a general ban on importing removes a regulation that is no longer
This reflects the termination of all
into the United States any article that is applicable or enforced by CBP in light
Burmese sanctions by Executive Order
a product of Burma; however, the of the Executive Order, CBP has
13742, of October 7, 2016.
specific ban of jadeite and rubies mined determined it is a nondiscretionary
DATES: This final rule is effective on action and that, pursuant to the
October 30, 2017. or extracted from Burma as well as
articles of jewelry containing jadeite or provisions of 5 U.S.C. 553(b)(B), prior
FOR FURTHER INFORMATION CONTACT: public notice and comment procedures
rubies mined or extracted from Burma
Daniel Collier, Partner Government was reinstituted by E.O. 13651. on this regulation are impracticable,
Agency Branch, Trade Policy and Consequently, on August 23, 2016, CBP unnecessary, and contrary to the public
Programs, Office of Trade, (202) 863– published a final rule in the Federal interest and that there is good cause for
6225, Daniel.Collier@cbp.dhs.gov; or Register (81 FR 57456) amending the this rule to become effective
William Scopa, Branch Chief, Partner CBP regulations to update the relevant immediately upon publication. For
Government Agency Branch, Trade provisions to reflect the import these reasons, pursuant to the provision
Policy and Programs, Office of Trade, prohibitions set forth in E.O. 13651. of 5 U.S.C. 553(d)(3), CBP finds that
(202) 863–6554, William.R.Scopa@ there is good cause for dispensing with
cbp.dhs.gov. II. Termination of the Burmese a delayed effective date.
Sanctions
SUPPLEMENTARY INFORMATION:
On October 7, 2016, the President B. Executive Orders 13563 and 12866:
I. Background signed E.O. 13742, titled ‘‘Termination Regulatory Planning and Review
On July 28, 2003, the President signed of Emergency With Respect to the Executive Orders 13563 and 12866
into law the Burmese Freedom and Actions and Policies of the Government direct agencies to assess the costs and
Democracy Act of 2003 (Pub. L. 108–61) of Burma’’ (81 FR 70593), which benefits of available regulatory
(the ‘‘BFDA’’) to sanction the military revoked, among others, E.O. 13310 and alternatives and, if regulation is
junta then ruling Burma. Among other 13651. The President found that the necessary, to select regulatory
provisions, the BFDA required the situation that gave rise to the approaches that maximize net benefits
imposition, subject to annual renewal, declaration of a national emergency (including potential economic,
of a ban on the importation into the with respect to the actions and policies environmental, public health and safety
United States of any article that is a of the Government of Burma has been effects, distributive impacts, and
product of Burma. To implement the significantly altered by Burma’s equity). Executive Order 13563
BFDA, the President issued Executive substantial advances in promoting emphasizes the importance of
Order (‘‘E.O.’’) 13310 (68 FR 44853, July democracy, including historic elections quantifying both costs and benefits, of
that resulted in the formation of a reducing costs, of harmonizing rules,
nlaroche on DSK9F9SC42PROD with RULES

30, 2003), which prohibited, among
other things, the importation into the democratically elected, civilian-led and of promoting flexibility. This rule is
United States of any article that is a government; the release of many not a ‘‘significant regulatory action,’’
product of Burma. political prisoners; and greater under section 3(f) of Executive Order
On July 29, 2008, the President signed enjoyment of human rights and 12866. Accordingly, the Office of
into law the Tom Lantos Block Burmese fundamental freedoms, including Management and Budget has not
JADE (Junta’s Anti-Democratic Efforts) freedom of expression and freedom of 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 DEPARTMENT OF HEALTH AND (see 21 U.S.C. 360c(f)(1)). We refer to
HUMAN SERVICES these devices as ‘‘postamendments
The Regulatory Flexibility Act (5 devices’’ because they were not in
U.S.C. 601 et seq.), as amended by the Food and Drug Administration commercial distribution prior to the
Small Business Regulatory Enforcement date of enactment of the Medical Device
and Fairness Act of 1996, requires an 21 CFR Part 862 Amendments of 1976, which amended
agency to prepare and make available to the Federal Food, Drug, and Cosmetic
[Docket No. FDA–2017–N–5685]
the public a regulatory flexibility Act (the FD&C Act).
analysis that describes the effect of a Medical Devices; Clinical Chemistry FDA may take a variety of actions in
proposed rule on small entities (i.e., and Clinical Toxicology Devices; appropriate circumstances to classify or
small businesses, small organizations, Classification of the Acute Kidney reclassify a device into class I or II. We
and small governmental jurisdictions) Injury Test System may issue an order finding a new device
when the agency is required to publish to be substantially equivalent under
a general notice of proposed rulemaking AGENCY: Food and Drug Administration, section 513(i) of the FD&C Act to a
for a rule. As a notice of proposed HHS. predicate device that does not require
ACTION: Final order. premarket approval (see 21 U.S.C.
rulemaking is not necessary for this
360c(i)). We determine whether a new
rule, CBP is not required to prepare a SUMMARY: The Food and Drug device is substantially equivalent to a
regulatory flexibility analysis for this Administration (FDA or we) is predicate by means of the procedures
rule. classifying the acute kidney injury test for premarket notification under section
D. Signing Authority system into class II (special controls). 510(k) of the FD&C Act and part 807 (21
The special controls that apply to the U.S.C. 360(k) and 21 CFR part 807,
This regulation is being issued in device type are identified in this order respectively).
accordance with 19 CFR 0.1(a)(1) and will be part of the codified language FDA may also classify a device
pertaining to the Secretary of the for the acute kidney injury test system’s through ‘‘De Novo’’ classification, a
Treasury’s authority (or that of his classification. We are taking this action common name for the process
delegate) to approve regulations related because we have determined that authorized under section 513(f)(2) of the
to certain customs revenue functions. classifying the device into class II FD&C Act. Section 207 of the Food and
(special controls) will provide a Drug Administration Modernization Act
List of Subjects in 19 CFR Part 12 reasonable assurance of safety and of 1997 established the first procedure
effectiveness of the device. We believe for De Novo classification (Pub. L. 105–
Customs duties and inspection, 115). Section 607 of the Food and Drug
this action will also enhance patients’
Reporting and recordkeeping Administration Safety and Innovation
access to beneficial innovative devices,
requirements. Act modified the De Novo application
in part by reducing regulatory burdens.
Amendments to the Regulations DATES: This order is effective October
process by adding a second procedure
30, 2017. The classification was (Pub. L. 112–144). A device sponsor
For the reasons set forth in the applicable on September 5, 2014. may utilize either procedure for De
preamble, part 12 of title 19 of the Code Novo classification.
FOR FURTHER INFORMATION CONTACT: Seth Under the first procedure, the person
of Federal Regulations (19 CFR part 12)
Olson, Center for Devices and submits a 510(k) for a device that has
is amended as set forth below. Radiological Health, Food and Drug not previously been classified. After
PART 12—SPECIAL CLASSES OF Administration, 10903 New Hampshire receiving an order from FDA classifying
Ave., Bldg. 66, Rm. 4561, Silver Spring, the device into class III under section
MERCHANDISE
MD 20993–0002, 301–796–4364, 513(f)(1) of the FD&C Act, the person
Jeremy.Olson@fda.hhs.gov. then requests a classification under
■ 1. The general authority citation for
SUPPLEMENTARY INFORMATION: section 513(f)(2).
part 12 continues to read as follows:
I. Background Under the second procedure, rather
Authority: 5 U.S.C. 301; 19 U.S.C. 66, 1202 than first submitting a 510(k) and then
(General Note 3(i), Harmonized Tariff Upon request, FDA has classified the a request for classification, if the person
Schedule of the United States (HTSUS)), acute kidney injury test system as class determines that there is no legally
1624. II (special controls), which we have marketed device upon which to base a
* * * * * determined will provide a reasonable determination of substantial
assurance of safety and effectiveness. In equivalence, that person requests a
■ 2. The specific authority citation for addition, we believe this action will classification under section 513(f)(2) of
§ 12.151 is removed. enhance patients’ access to beneficial the FD&C Act.
§ 12.151 [Removed and Reserved] innovation, in part by reducing Under either procedure for De Novo
regulatory burdens by placing the classification, FDA is required to
■ 3. Remove and reserve § 12.151. device into a lower device class than the classify the device by written order
automatic class III assignment. within 120 days. The classification will
Dated: October 25, 2017.
The automatic assignment of class III be according to the criteria under
Kevin K. McAleenan, occurs by operation of law and without section 513(a)(1) of the FD&C Act.
Acting Commissioner, U.S. Customs and any action by FDA, regardless of the Although the device was automatically
Border Protection. level of risk posed by the new device.
nlaroche on DSK9F9SC42PROD with RULES

placed within class III, the De Novo
Approved: Any device that was not in commercial classification is considered to be the
distribution before May 28, 1976, is initial classification of the device.
Timothy E. Skud,
automatically classified as, and remains We believe this De Novo classification
Deputy Assistant Secretary of the Treasury. within, class III and requires premarket will enhance patients’ access to
[FR Doc. 2017–23560 Filed 10–27–17; 8:45 am] approval unless and until FDA takes an beneficial innovation, in part by
BILLING CODE 9111–14–P action to classify or reclassify the device reducing regulatory burdens. When FDA

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Document Created: 2017-10-28 00:29:21
Document Modified: 2017-10-28 00:29:21

Category		Regulatory Information
Collection		Federal Register
sudoc Class		AE 2.7: GS 4.107: AE 2.106:
Publisher		Office of the Federal Register, National Archives and Records Administration
Section		Rules and Regulations
Action		Final rule.
Dates		This final rule is effective on October 30, 2017.
Contact		Daniel Collier, Partner Government Agency Branch, Trade Policy and Programs, Office of Trade, (202) 863- 6225, [email protected]; or William Scopa, Branch Chief, Partner Government Agency Branch, Trade Policy and Programs, Office of Trade, (202) 863-6554, [email protected]
FR Citation		82 FR 50070
RIN Number		1515-AE27
CFR Associated		Customs Duties and Inspection and Reporting and Recordkeeping Requirements

82 FR 50070 - 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

DEPARTMENT OF HOMELAND SECURITYU.S. Customs and Border ProtectionDEPARTMENT OF THE TREASURY

Federal Register Volume 82, Issue 208 (October 30, 2017)

DEPARTMENT OF HOMELAND SECURITY
U.S. Customs and Border Protection
DEPARTMENT OF THE TREASURY