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, 50070-50071 [2017-23560]
Download as PDF
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
U.S. Customs and Border
Protection, Department of Homeland
Security; Department of Treasury.
ACTION: Final rule.
AGENCY:
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:
nlaroche on DSK9F9SC42PROD with RULES
SUMMARY:
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)
VerDate Sep<11>2014
13:41 Oct 27, 2017
Jkt 244001
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
PO 00000
Frm 00012
Fmt 4700
Sfmt 4700
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.
E:\FR\FM\30OCR1.SGM
30OCR1
Federal Register / Vol. 82, No. 208 / Monday, October 30, 2017 / Rules and Regulations
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
nlaroche on DSK9F9SC42PROD with RULES
■
[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
VerDate Sep<11>2014
13:41 Oct 27, 2017
Jkt 244001
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.
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:
SUMMARY:
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
PO 00000
Frm 00013
Fmt 4700
Sfmt 4700
50071
(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
E:\FR\FM\30OCR1.SGM
30OCR1
Agencies
[Federal Register Volume 82, Number 208 (Monday, October 30, 2017)]
[Rules and Regulations]
[Pages 50070-50071]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2017-23560]
[[Page 50070]]
=======================================================================
-----------------------------------------------------------------------
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