81_FR_52478 81 FR 52326 - Amendment to the Export Administration Regulations To Add Targets for the Production of Tritium and Related Development and Production Technology to the List of 0Y521 Series

81 FR 52326 - Amendment to the Export Administration Regulations To Add Targets for the Production of Tritium and Related Development and Production Technology to the List of 0Y521 Series

DEPARTMENT OF COMMERCE
Bureau of Industry and Security

Federal Register Volume 81, Issue 152 (August 8, 2016)

Page Range52326-52329
FR Document2016-18070

In this interim final rule, the Bureau of Industry and Security (BIS) amends the Export Administration Regulations (EAR) to make certain items subject to the EAR and to impose on those items a license requirement for export and reexport to all destinations, except Canada. Specifically, this rule classifies certain specified targets ``specially designed'' for the production of tritium and related ``development'' and ``production'' technology under Export Control Classification Numbers (ECCNs) 0A521 and 0E521, respectively, on the Commerce Control List (CCL). As described in the final rule that established the 0Y521 series and that was published in the Federal Register on April 13, 2012, items are added to the 0Y521 series upon a determination by the Department of Commerce, with the concurrence of the Departments of Defense and State, and other agencies as appropriate, that the items should be controlled for export because the items provide at least a significant military or intelligence advantage to the United States or foreign policy reasons justify control. In this matter, the Department of Energy also concurred in the control imposed. The items identified in this rule are controlled for regional stability (RS) Column 1 reasons. The only license exception available for these items is for exports, reexports, and transfers (in-country) made by or consigned to a department or agency of the U.S. Government.

Federal Register, Volume 81 Issue 152 (Monday, August 8, 2016)
[Federal Register Volume 81, Number 152 (Monday, August 8, 2016)]
[Rules and Regulations]
[Pages 52326-52329]
From the Federal Register Online  [www.thefederalregister.org]
[FR Doc No: 2016-18070]


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DEPARTMENT OF COMMERCE

Bureau of Industry and Security

15 CFR Part 774

[Docket No. 160303184-6184-01]
RIN 0694-AG90


Amendment to the Export Administration Regulations To Add Targets 
for the Production of Tritium and Related Development and Production 
Technology to the List of 0Y521 Series

AGENCY: Bureau of Industry and Security, Commerce.

ACTION: Interim final rule with request for comments.

-----------------------------------------------------------------------

SUMMARY: In this interim final rule, the Bureau of Industry and 
Security (BIS) amends the Export Administration Regulations (EAR) to 
make certain items subject to the EAR and to impose on those items a 
license requirement for export and reexport to all destinations, except 
Canada. Specifically, this rule classifies certain specified targets 
``specially designed'' for the production of tritium and related 
``development'' and ``production'' technology under Export Control 
Classification Numbers (ECCNs) 0A521 and 0E521, respectively, on the 
Commerce Control List (CCL). As described in the final rule that 
established the 0Y521 series and that was published in the Federal 
Register on April 13, 2012, items are added to the 0Y521 series upon a 
determination by the Department of Commerce, with the concurrence of 
the Departments of Defense and State, and other agencies as 
appropriate, that the items should be controlled for export because the 
items provide at least a significant military or intelligence advantage 
to the United States or foreign policy reasons justify control. In this 
matter, the Department of Energy also concurred in the control imposed. 
The items identified in this rule are controlled for regional stability 
(RS) Column 1 reasons. The only license exception available for these 
items is for exports, reexports, and transfers (in-country) made by or 
consigned to a department or agency of the U.S. Government.

[[Page 52327]]


DATES: This rule is effective August 8, 2016. Comments must be received 
by October 7, 2016.

ADDRESSES: You may submit comments by any of the following methods:
     Federal eRulemaking Portal: http://www.regulations.gov. 
The identification number for this rulemaking is BIS-2016-0027.
     By email directly to: doc.gov">[email protected]doc.gov. Include 
RIN 0694-AG90 in the subject line.
     By mail or delivery to Regulatory Policy Division, Bureau 
of Industry and Security, U.S. Department of Commerce, Room 2099B, 14th 
Street and Pennsylvania Avenue NW., Washington, DC 20230. Refer to RIN 
0694-AG90.

FOR FURTHER INFORMATION CONTACT: Steven Clagett, Director, Nuclear and 
Missile Technology Controls Division, Office of Nonproliferation and 
Treaty Compliance, by phone at (202) 482-1641, or by email at 
[email protected] doc.gov.

SUPPLEMENTARY INFORMATION: 

Background

    BIS established the ECCN 0Y521 series to identify items that 
warrant control on the CCL but are not yet identified in an existing 
ECCN (77 FR 22191, April 13, 2012). Items are added to the ECCN 0Y521 
series by the Department of Commerce, with the concurrence of the 
Departments of Defense and State, and other agencies as appropriate, 
upon a determination that an item should be controlled because it 
provides at least a significant military or intelligence advantage to 
the United States or because foreign policy reasons justify such 
control. In this matter, the Department of Energy also concurred in the 
control imposed. The ECCN 0Y521 series is a temporary holding 
classification with a limitation that while an item is temporarily 
classified under ECCN 0Y521, the U.S. Government works to adopt a 
control through the relevant multilateral regime(s), in this case the 
Nuclear Suppliers Group, to determine an appropriate longer-term 
control over the item, or that the item does not warrant control on the 
CCL.
    Items classified under ECCN 0Y521, including the items identified 
in this interim final rule as 0A521 and 0E521 items, remain so-
classified for one year from the date a final rule identifying the item 
is published in the Federal Register amending the EAR, unless the item 
is re-classified under a different ECCN, under an EAR99 designation, or 
the 0Y521 classification is extended. During this time, the U.S. 
Government determines whether it is appropriate to submit a proposed 
control to the applicable export control regime (e.g., the Nuclear 
Suppliers Group) for potential multilateral control, with the 
understanding that multilateral controls are preferable when practical. 
An item's ECCN 0Y521 classification may be extended for two one-year 
periods to provide time for the U.S. Government and multilateral 
regime(s) to reach agreement on controls for the item, and provided 
that the U.S. Government has submitted a proposal to obtain 
multilateral controls over the item. Further extension beyond three 
years may occur only if the Under Secretary for Industry and Security 
makes a determination that such extension is in the national security 
or foreign policy interests of the United States. An extension or re-
extension, including a determination by the Under Secretary for 
Industry and Security, will be published in the Federal Register.

License Requirements, Policies and Exceptions

    The license requirements and policies for the ECCN 0Y521 series 
appear in Sec.  742.6(a)(7) of the EAR. ECCN 0Y521 items are subject to 
a nearly worldwide license requirement (i.e., for every country except 
Canada) with a case-by-case license review policy, through regional 
stability (RS Column 1) controls. The description and status of ECCN 
0Y521 items appear in Supplement No. 5 to part 774 of the EAR, along 
with any item-specific license exceptions, where applicable. Unless 
otherwise indicated, License Exception GOV is the only license 
exception available and is applicable to all ECCN 0Y521 series items, 
including those items identified in this notice, if the item is within 
the scope of Sec.  740.11(b)(2)(ii) (Exports, reexports, and transfers 
(in-country) made by or consigned to a department or agency of the U.S. 
Government), as provided in Sec.  740.2(a)(14).

Addition of ECCN 0A521 and 0E521 Items: Targets for the Production of 
Tritium and Related ``Development'' and ``Production'' Technology

    In this rule, BIS amends the EAR to make targets made of or 
containing lithium ``specially designed'' for the production of tritium 
by insertion in the core of a nuclear reactor and related 
``development'' and ``production'' technology subject to the EAR and 
imposes a license requirement on the items. These items are being added 
to the 0Y521 series pursuant to a determination by the Department of 
Commerce, with the concurrence of the Departments of Defense, State and 
Energy, that the items should be controlled because they provide a 
significant military or intelligence advantage to the United States or 
because foreign policy reasons justify such controls.
    ECCN 0A521 No. 1, which appears in the table found in Supplement 
No. 5 to part 774 of the EAR, covers targets made of or containing 
lithium ``specially designed'' for the production of tritium by 
insertion in the core of a nuclear reactor.
    ECCN 0E521 No. 1 covers technology required for the ``development'' 
or ``production'' of items classified under ECCN 0A521 No. 1.

License Applications for the New ECCN 0A521 and 0E521 Items

    License applications for these items may be submitted through SNAP-
R in accordance with Sec.  748.6 of the EAR. Exporters are directed to 
include detailed descriptions and technical specifications with the 
license application, and identify the item's ECCN.
    The rule is being issued in interim final form because while the 
government believes that it is in the national security interests of 
the United States to immediately implement these controls, it also 
wants to provide the interested public with an opportunity to comment 
on the new controls of the items. Comments may be submitted in 
accordance with the DATES and ADDRESSES sections of this rule. BIS will 
review and, if appropriate, address such comments through rulemaking 
consistent with the process described in the April 13, 2012 final rule 
creating the ECCN 0Y521 series (77 FR 22191).

Export Administration Act

    Although the Export Administration Act expired on August 20, 2001, 
the President, through Executive Order 13222 of August 17, 2001, 3 CFR, 
2001 Comp., p. 783 (2002), as amended by Executive Order 13637 of March 
8, 2013, 78 FR 16129 (March 13, 2013) and as extended by the Notice of 
August 7, 2015, 80 FR 48233 (August 11, 2015), has continued the Export 
Administration Regulations in effect under the International Emergency 
Economic Powers Act. BIS continues to carry out the provisions of the 
Export Administration Act, as appropriate and to the extent permitted 
by law, pursuant to Executive Order 13222 as amended by Executive Order 
13637.

Rulemaking Requirements

    1. Executive Orders 13563 and 12866 direct agencies to assess all 
costs and benefits of available regulatory

[[Page 52328]]

alternatives and, if regulation is necessary, to select regulatory 
approaches that maximize net benefits (including potential economic, 
environmental, public health and safety effects, distribute 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 has been determined to 
be not significant for purposes of Executive Order 12866.
    2. Notwithstanding any other provision of law, no person is 
required to respond to, nor is subject to a penalty for failure to 
comply with, a collection of information, subject to the requirements 
of the Paperwork Reduction Act of 1995 (44 U.S.C. 3501 et seq.) (PRA), 
unless that collection of information displays a currently valid OMB 
control number. This rule affects two approved collections: (1) The 
Simplified Network Application Processing + System (control number 
0694-0088), which carries a burden hour estimate of 43.8 minutes, 
including the time necessary to submit license applications, among 
other things, as well as miscellaneous and other recordkeeping 
activities that account for 12 minutes per submission; and (2) License 
Exceptions and Exclusions (0694-0137). BIS does not believe that this 
rule will materially increase the number of submissions under these 
collections.
    3. This rule does not contain policies with Federalism implications 
as that term is defined under E.O. 13132.
    4. The provisions of the Administrative Procedure Act (5 U.S.C. 
553) requiring prior notice, the opportunity for public comment and a 
delay in effective date are inapplicable because this regulation 
involves a military or foreign affairs function of the United States 
(See 5 U.S.C. 553(a)(1)). BIS, with the concurrence of the U.S. 
Departments of Defense and State, is implementing this rule because the 
items identified for the ECCN 0Y521 series in this rule provide a 
significant military or intelligence advantage to the United States. 
Immediate imposition of a license requirement is necessary to effect 
the national security and foreign policy goals of this rule. Immediate 
implementation will allow BIS to prevent exports of these items to 
users and for uses that pose a national security threat to the United 
States or its allies. If BIS delayed this rule to allow for prior 
notice and opportunity for public comment, the resulting delay in 
implementation would afford an opportunity for the export of these 
items to users and uses that pose such a national security threat, 
thereby undermining the purpose of the rule. In addition, if parties 
receive notice of the U.S. Government's intention to control these 
items under 0Y521 once a final rule was published, they might have an 
incentive to either accelerate orders of these items or attempt to have 
the items exported prior to the imposition of the control.
    Further, BIS finds good cause to waive the 30-day delay in 
effectiveness under 5 U.S.C. 553(d)(3). Immediate implementation of 
these changes will allow BIS to prevent exports of these items to users 
and for uses that pose a national security threat to the United States 
or its allies. If BIS delayed this rule to allow for a 30-day delay in 
effectiveness, the resulting delay in implementation would afford an 
opportunity for the export of these items to users and uses that pose 
such a national security threat, thereby undermining the purpose of the 
rule. Because a notice of proposed rulemaking and an opportunity for 
public comment are not required to be given for this rule by 5 U.S.C. 
553, or by any other law, the analytical requirements of the Regulatory 
Flexibility Act, 5 U.S.C. 601 et seq., are not applicable. Accordingly, 
no regulatory flexibility analysis is required and none has been 
prepared. Although notice and opportunity for comment are not required, 
BIS is issuing this rule as an interim final rule with a request for 
comments. All comments must be in writing and submitted via one or more 
of the methods listed under the ADDRESSES caption to this notice. All 
comments (including any personal identifiable information) will be 
available for public inspection and copying. Those wishing to comment 
anonymously may do so by submitting their comment via regulations.gov 
and leaving the fields for identifying information blank.

List of Subjects in 15 CFR Part 774

    Exports, Reporting and recordkeeping requirements.

    Accordingly, part 774 of the Export Administration Regulations (15 
CFR parts 730-774) is amended as follows:

PART 774--[AMENDED]

0
1. The authority citation for part 774 continues to read as follows:

    Authority:  50 U.S.C. app. 2401 et seq.; 50 U.S.C. 1701 et seq.; 
10 U.S.C. 7420; 10 U.S.C. 7430(e); 22 U.S.C. 287c, 22 U.S.C. 3201 et 
seq.; 22 U.S.C. 6004; 42 U.S.C. 2139a; 42 U.S.C. 6212; 15 U.S.C. 
1824a; 50 U.S.C. 4305; 22 U.S.C. 7201 et seq.; 22 U.S.C. 7210; 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 7, 2015, 80 FR 
48233 (August 11, 2015).


0
2. Amend Supplement No. 5 to Part 774 by:
0
A. In the table, remove the reserved entry under 0A521 and add in its 
place entry No. 1.
0
B. In the table, remove the reserved entry under 0E521 and add in its 
place entry No. 1.
    The additions read as follows:

Supplement No. 5 to Part 774--Items Classified Under ECCNS 0A521, 
0B521, 0C521, 0D521 AND 0E521

    The following table lists items subject to the EAR that are not 
listed elsewhere in the CCL, but which the Department of Commerce, 
with the concurrence of the Departments of Defense and State, has 
identified warrant control for export or reexport because the items 
provide at least a significant military or intelligence advantage to 
the United States or for foreign policy reasons.

----------------------------------------------------------------------------------------------------------------
   Item descriptor Note: The                                      Date when the item will be
description must match by model        Date of initial or          designated EAR99, unless      Item-specific
 number or a broader descriptor          subsequent BIS          reclassified in another ECCN  license exception
 that does not necessarily need   classification (ID = initial   or the 0Y521 classification      eligibility
     to be company specific       date; SD = subsequent date)            is  reissued
----------------------------------------------------------------------------------------------------------------
                                    0A521. Systems, Equipment and Components.
----------------------------------------------------------------------------------------------------------------
No. 1 Targets made of or         August 8, 2016 (ID)..........  August 8, 2017...............  License Exception
 containing lithium ``specially                                                                 GOV under Sec.
 designed'' for the production                                                                  740.11(b)(2)(ii)
 of tritium by insertion in the                                                                 only.
 core of a nuclear reactor.
 

[[Page 52329]]

 
                                                  * * * * * * *
----------------------------------------------------------------------------------------------------------------
                                               0E521. Technology.
----------------------------------------------------------------------------------------------------------------
No. 1 ``Technology'' required    August 8, 2016 (ID)..........  August 8, 2017...............  License Exception
 for the ``development'' or                                                                     GOV under Sec.
 ``production'' of 0A521 No. 1                                                                  740.11(b)(2)(ii)
 items.                                                                                         only.
----------------------------------------------------------------------------------------------------------------


    Dated: July 25, 2016.
Matthew S. Borman,
Deputy Assistant Secretary for Export Administration.
[FR Doc. 2016-18070 Filed 8-5-16; 8:45 am]
 BILLING CODE 3510-33-P



                                             52326              Federal Register / Vol. 81, No. 152 / Monday, August 8, 2016 / Rules and Regulations

                                             California has demonstrated that the                    0.02 percent of the approximately $10                    Done in Washington, DC, this 29th day of
                                             State meets the criteria for accredited-                billion earned from California’s cattle                July 2016.
                                             free status as set forth in the definition              and milk sales.                                        Kevin Shea,
                                             of accredited-free State or zone in § 77.5                 Entities that may be affected by the                Administrator, Animal and Plant Health
                                             of the regulations.                                     interim rule fall into various categories              Inspection Service.
                                                Based on our evaluation of                           of the North American Industry                         [FR Doc. 2016–18428 Filed 8–5–16; 8:45 am]
                                             California’s request, we are classifying                Classification System. The majority of                 BILLING CODE 3410–34–P
                                             the entire State of California as
                                                                                                     the affected businesses are small
                                             accredited-free.
                                                                                                     entities.
                                             Immediate Action                                           Under these circumstances, the                      DEPARTMENT OF COMMERCE
                                               Immediate action is warranted to                      Administrator of the Animal and Plant
                                             relieve restrictions on the interstate                  Health Inspection Service has                          Bureau of Industry and Security
                                             movement of cattle and bison from the                   determined that this action will not
                                             State of California. Under these                        have a significant economic impact on                  15 CFR Part 774
                                             circumstances, the Administrator has                    a substantial number of small entities.
                                                                                                                                                            [Docket No. 160303184–6184–01]
                                             determined that prior notice and
                                                                                                     Executive Order 12372
                                             opportunity for public comment are                                                                             RIN 0694–AG90
                                             contrary to the public interest and that                  This program/activity is listed in the
                                             there is good cause under 5 U.S.C. 553                  Catalog of Federal Domestic Assistance                 Amendment to the Export
                                             for making this action effective less than              under No. 10.025 and is subject to                     Administration Regulations To Add
                                             30 days after publication in the Federal                Executive Order 12372, which requires                  Targets for the Production of Tritium
                                             Register.                                               intergovernmental consultation with                    and Related Development and
                                               We will consider comments we                          State and local officials. (See 2 CFR                  Production Technology to the List of
                                             receive during the comment period for                   chapter IV.)                                           0Y521 Series
                                             this interim rule (see DATES above).
                                             After the comment period closes, we                     Executive Order 12988                                  AGENCY:  Bureau of Industry and
                                             will publish another document in the                                                                           Security, Commerce.
                                             Federal Register. The document will                        This rule has been reviewed under                   ACTION: Interim final rule with request
                                             include a discussion of any comments                    Executive Order 12988, Civil Justice                   for comments.
                                             we receive and any amendments we are                    Reform. This rule has no retroactive
                                             making to the rule.                                     effect and does not require                            SUMMARY:    In this interim final rule, the
                                                                                                     administrative proceedings before                      Bureau of Industry and Security (BIS)
                                             Executive Order 12866 and Regulatory                    parties may file suit in court challenging             amends the Export Administration
                                             Flexibility Act                                         this rule.                                             Regulations (EAR) to make certain items
                                               This interim rule is subject to                                                                              subject to the EAR and to impose on
                                                                                                     Paperwork Reduction Act
                                             Executive Order 12866. However, for                                                                            those items a license requirement for
                                             this action, the Office of Management                      This rule contains no new                           export and reexport to all destinations,
                                             and Budget has waived its review under                  information collection or recordkeeping                except Canada. Specifically, this rule
                                             Executive Order 12866.                                  requirements under the Paperwork                       classifies certain specified targets
                                               In accordance with the Regulatory                     Reduction Act of 1995 (44 U.S.C. 3501                  ‘‘specially designed’’ for the production
                                             Flexibility Act, we have analyzed the                   et seq.).                                              of tritium and related ‘‘development’’
                                             potential economic effects of this action                                                                      and ‘‘production’’ technology under
                                             on small entities. The analysis is                      List of Subjects in 9 CFR Part 77                      Export Control Classification Numbers
                                             summarized below. The full analysis                                                                            (ECCNs) 0A521 and 0E521, respectively,
                                                                                                       Animal diseases, Bison, Cattle,
                                             may be viewed on the Regulations.gov                                                                           on the Commerce Control List (CCL). As
                                                                                                     Reporting and recordkeeping
                                             Web site (see ADDRESSES above for                                                                              described in the final rule that
                                                                                                     requirements, Transportation,
                                             instructions for accessing                                                                                     established the 0Y521 series and that
                                                                                                     Tuberculosis.
                                             Regulations.gov) or obtained from the                                                                          was published in the Federal Register
                                             person listed under FOR FURTHER                           Accordingly, we are amending 9 CFR                   on April 13, 2012, items are added to
                                             INFORMATION CONTACT.                                    part 77 as follows:                                    the 0Y521 series upon a determination
                                                Tuberculosis testing, including                                                                             by the Department of Commerce, with
                                             veterinary fees, costs approximately $10                PART 77—TUBERCULOSIS                                   the concurrence of the Departments of
                                             to $15 per head. Approximately 100,000                                                                         Defense and State, and other agencies as
                                             tuberculosis tests were conducted in                    ■ 1. The authority citation for part 77                appropriate, that the items should be
                                             California in 2015, to meet the import                  continues to read as follows:                          controlled for export because the items
                                             requirements imposed by other States.                     Authority: 7 U.S.C. 8301–8317; 7 CFR                 provide at least a significant military or
                                             Based on this information, the annual                   2.22, 2.80, and 371.4.                                 intelligence advantage to the United
                                             cost savings associated with advancing                                                                         States or foreign policy reasons justify
                                             the tuberculosis status of California                   77.7    [Amended]                                      control. In this matter, the Department
                                             from modified accredited advanced to                                                                           of Energy also concurred in the control
                                             accredited-free will range from $1                      ■ 2. In § 77.7, paragraph (a) is amended               imposed. The items identified in this
                                             million to $1.5 million. We note that                   by adding the word ‘‘California,’’ after               rule are controlled for regional stability
rmajette on DSK2TPTVN1PROD with RULES




                                             Federal interstate movement testing                     the word ‘‘Arkansas,’’.                                (RS) Column 1 reasons. The only license
                                             requirements for modified accredited                    77.9    [Amended]                                      exception available for these items is for
                                             advanced States were suspended by a                                                                            exports, reexports, and transfers (in-
                                             Federal Order issued in April 2010. The                 ■ 3. In § 77.9, paragraph (a) is amended               country) made by or consigned to a
                                             $1 million to $1.5 million in savings                   by removing the word ‘‘California’’ and                department or agency of the U.S.
                                             that will be realized represents less than              adding the word ‘‘None’’ in its place.                 Government.


                                        VerDate Sep<11>2014   13:12 Aug 05, 2016   Jkt 238001   PO 00000    Frm 00002   Fmt 4700   Sfmt 4700   E:\FR\FM\08AUR1.SGM   08AUR1


                                                                Federal Register / Vol. 81, No. 152 / Monday, August 8, 2016 / Rules and Regulations                                         52327

                                             DATES: This rule is effective August 8,                 submit a proposed control to the                      Energy, that the items should be
                                             2016. Comments must be received by                      applicable export control regime (e.g.,               controlled because they provide a
                                             October 7, 2016.                                        the Nuclear Suppliers Group) for                      significant military or intelligence
                                             ADDRESSES: You may submit comments                      potential multilateral control, with the              advantage to the United States or
                                             by any of the following methods:                        understanding that multilateral controls              because foreign policy reasons justify
                                               • Federal eRulemaking Portal: http://                 are preferable when practical. An item’s              such controls.
                                             www.regulations.gov. The identification                 ECCN 0Y521 classification may be                         ECCN 0A521 No. 1, which appears in
                                             number for this rulemaking is BIS–                      extended for two one-year periods to                  the table found in Supplement No. 5 to
                                             2016–0027.                                              provide time for the U.S. Government                  part 774 of the EAR, covers targets made
                                               • By email directly to:                               and multilateral regime(s) to reach                   of or containing lithium ‘‘specially
                                             publiccomments@bis.doc.gov. Include                     agreement on controls for the item, and               designed’’ for the production of tritium
                                             RIN 0694–AG90 in the subject line.                      provided that the U.S. Government has                 by insertion in the core of a nuclear
                                               • By mail or delivery to Regulatory                   submitted a proposal to obtain                        reactor.
                                             Policy Division, Bureau of Industry and                 multilateral controls over the item.                     ECCN 0E521 No. 1 covers technology
                                             Security, U.S. Department of Commerce,                  Further extension beyond three years                  required for the ‘‘development’’ or
                                             Room 2099B, 14th Street and                             may occur only if the Under Secretary                 ‘‘production’’ of items classified under
                                             Pennsylvania Avenue NW., Washington,                    for Industry and Security makes a                     ECCN 0A521 No. 1.
                                             DC 20230. Refer to RIN 0694–AG90.                       determination that such extension is in
                                                                                                                                                           License Applications for the New ECCN
                                             FOR FURTHER INFORMATION CONTACT:
                                                                                                     the national security or foreign policy
                                                                                                                                                           0A521 and 0E521 Items
                                             Steven Clagett, Director, Nuclear and                   interests of the United States. An
                                                                                                     extension or re-extension, including a                   License applications for these items
                                             Missile Technology Controls Division,                                                                         may be submitted through SNAP–R in
                                             Office of Nonproliferation and Treaty                   determination by the Under Secretary
                                                                                                     for Industry and Security, will be                    accordance with § 748.6 of the EAR.
                                             Compliance, by phone at (202) 482–                                                                            Exporters are directed to include
                                             1641, or by email at Steven.Clagett@bis                 published in the Federal Register.
                                                                                                                                                           detailed descriptions and technical
                                             doc.gov.                                                License Requirements, Policies and                    specifications with the license
                                             SUPPLEMENTARY INFORMATION:                              Exceptions                                            application, and identify the item’s
                                             Background                                                 The license requirements and policies              ECCN.
                                                                                                     for the ECCN 0Y521 series appear in                      The rule is being issued in interim
                                                BIS established the ECCN 0Y521                       § 742.6(a)(7) of the EAR. ECCN 0Y521                  final form because while the
                                             series to identify items that warrant                   items are subject to a nearly worldwide               government believes that it is in the
                                             control on the CCL but are not yet                      license requirement (i.e., for every                  national security interests of the United
                                             identified in an existing ECCN (77 FR                   country except Canada) with a case-by-                States to immediately implement these
                                             22191, April 13, 2012). Items are added                 case license review policy, through                   controls, it also wants to provide the
                                             to the ECCN 0Y521 series by the                         regional stability (RS Column 1)                      interested public with an opportunity to
                                             Department of Commerce, with the                        controls. The description and status of               comment on the new controls of the
                                             concurrence of the Departments of                       ECCN 0Y521 items appear in                            items. Comments may be submitted in
                                             Defense and State, and other agencies as                Supplement No. 5 to part 774 of the                   accordance with the DATES and
                                             appropriate, upon a determination that                  EAR, along with any item-specific                     ADDRESSES sections of this rule. BIS will
                                             an item should be controlled because it                 license exceptions, where applicable.                 review and, if appropriate, address such
                                             provides at least a significant military or             Unless otherwise indicated, License                   comments through rulemaking
                                             intelligence advantage to the United                    Exception GOV is the only license                     consistent with the process described in
                                             States or because foreign policy reasons                exception available and is applicable to              the April 13, 2012 final rule creating the
                                             justify such control. In this matter, the               all ECCN 0Y521 series items, including                ECCN 0Y521 series (77 FR 22191).
                                             Department of Energy also concurred in                  those items identified in this notice, if
                                             the control imposed. The ECCN 0Y521                     the item is within the scope of                       Export Administration Act
                                             series is a temporary holding                           § 740.11(b)(2)(ii) (Exports, reexports,                 Although the Export Administration
                                             classification with a limitation that                   and transfers (in-country) made by or                 Act expired on August 20, 2001, the
                                             while an item is temporarily classified                 consigned to a department or agency of                President, through Executive Order
                                             under ECCN 0Y521, the U.S.                              the U.S. Government), as provided in                  13222 of August 17, 2001, 3 CFR, 2001
                                             Government works to adopt a control                     § 740.2(a)(14).                                       Comp., p. 783 (2002), as amended by
                                             through the relevant multilateral                                                                             Executive Order 13637 of March 8,
                                             regime(s), in this case the Nuclear                     Addition of ECCN 0A521 and 0E521
                                                                                                                                                           2013, 78 FR 16129 (March 13, 2013) and
                                             Suppliers Group, to determine an                        Items: Targets for the Production of
                                                                                                                                                           as extended by the Notice of August 7,
                                             appropriate longer-term control over the                Tritium and Related ‘‘Development’’
                                                                                                                                                           2015, 80 FR 48233 (August 11, 2015),
                                             item, or that the item does not warrant                 and ‘‘Production’’ Technology
                                                                                                                                                           has continued the Export
                                             control on the CCL.                                        In this rule, BIS amends the EAR to                Administration Regulations in effect
                                                Items classified under ECCN 0Y521,                   make targets made of or containing                    under the International Emergency
                                             including the items identified in this                  lithium ‘‘specially designed’’ for the                Economic Powers Act. BIS continues to
                                             interim final rule as 0A521 and 0E521                   production of tritium by insertion in the             carry out the provisions of the Export
                                             items, remain so-classified for one year                core of a nuclear reactor and related                 Administration Act, as appropriate and
                                             from the date a final rule identifying the              ‘‘development’’ and ‘‘production’’                    to the extent permitted by law, pursuant
                                             item is published in the Federal                        technology subject to the EAR and
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                                                                                                                                                           to Executive Order 13222 as amended
                                             Register amending the EAR, unless the                   imposes a license requirement on the                  by Executive Order 13637.
                                             item is re-classified under a different                 items. These items are being added to
                                             ECCN, under an EAR99 designation, or                    the 0Y521 series pursuant to a                        Rulemaking Requirements
                                             the 0Y521 classification is extended.                   determination by the Department of                      1. Executive Orders 13563 and 12866
                                             During this time, the U.S. Government                   Commerce, with the concurrence of the                 direct agencies to assess all costs and
                                             determines whether it is appropriate to                 Departments of Defense, State and                     benefits of available regulatory


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                                             52328              Federal Register / Vol. 81, No. 152 / Monday, August 8, 2016 / Rules and Regulations

                                             alternatives and, if regulation is                      military or intelligence advantage to the                writing and submitted via one or more
                                             necessary, to select regulatory                         United States. Immediate imposition of                   of the methods listed under the
                                             approaches that maximize net benefits                   a license requirement is necessary to                    ADDRESSES caption to this notice. All
                                             (including potential economic,                          effect the national security and foreign                 comments (including any personal
                                             environmental, public health and safety                 policy goals of this rule. Immediate                     identifiable information) will be
                                             effects, distribute impacts, and equity).               implementation will allow BIS to                         available for public inspection and
                                             Executive Order 13563 emphasizes the                    prevent exports of these items to users                  copying. Those wishing to comment
                                             importance of quantifying both costs                    and for uses that pose a national                        anonymously may do so by submitting
                                             and benefits, of reducing costs, of                     security threat to the United States or its              their comment via regulations.gov and
                                             harmonizing rules, and of promoting                     allies. If BIS delayed this rule to allow                leaving the fields for identifying
                                             flexibility. This rule has been                         for prior notice and opportunity for                     information blank.
                                             determined to be not significant for                    public comment, the resulting delay in
                                                                                                                                                              List of Subjects in 15 CFR Part 774
                                             purposes of Executive Order 12866.                      implementation would afford an
                                                2. Notwithstanding any other                         opportunity for the export of these items                  Exports, Reporting and recordkeeping
                                             provision of law, no person is required                 to users and uses that pose such a                       requirements.
                                             to respond to, nor is subject to a penalty              national security threat, thereby                          Accordingly, part 774 of the Export
                                             for failure to comply with, a collection                undermining the purpose of the rule. In                  Administration Regulations (15 CFR
                                             of information, subject to the                          addition, if parties receive notice of the               parts 730–774) is amended as follows:
                                             requirements of the Paperwork                           U.S. Government’s intention to control
                                             Reduction Act of 1995 (44 U.S.C. 3501                   these items under 0Y521 once a final                     PART 774—[AMENDED]
                                             et seq.) (PRA), unless that collection of               rule was published, they might have an
                                             information displays a currently valid                  incentive to either accelerate orders of                 ■ 1. The authority citation for part 774
                                             OMB control number. This rule affects                   these items or attempt to have the items                 continues to read as follows:
                                             two approved collections: (1) The                       exported prior to the imposition of the                    Authority: 50 U.S.C. app. 2401 et seq.; 50
                                             Simplified Network Application                          control.                                                 U.S.C. 1701 et seq.; 10 U.S.C. 7420; 10 U.S.C.
                                             Processing + System (control number                        Further, BIS finds good cause to                      7430(e); 22 U.S.C. 287c, 22 U.S.C. 3201 et
                                             0694–0088), which carries a burden                      waive the 30-day delay in effectiveness                  seq.; 22 U.S.C. 6004; 42 U.S.C. 2139a; 42
                                             hour estimate of 43.8 minutes, including                under 5 U.S.C. 553(d)(3). Immediate                      U.S.C. 6212; 15 U.S.C. 1824a; 50 U.S.C. 4305;
                                                                                                                                                              22 U.S.C. 7201 et seq.; 22 U.S.C. 7210; E.O.
                                             the time necessary to submit license                    implementation of these changes will                     13026, 61 FR 58767, 3 CFR, 1996 Comp., p.
                                             applications, among other things, as                    allow BIS to prevent exports of these                    228; E.O. 13222, 66 FR 44025, 3 CFR, 2001
                                             well as miscellaneous and other                         items to users and for uses that pose a                  Comp., p. 783; Notice of August 7, 2015, 80
                                             recordkeeping activities that account for               national security threat to the United                   FR 48233 (August 11, 2015).
                                             12 minutes per submission; and (2)                      States or its allies. If BIS delayed this
                                                                                                                                                              ■ 2. Amend Supplement No. 5 to Part
                                             License Exceptions and Exclusions                       rule to allow for a 30-day delay in
                                                                                                                                                              774 by:
                                             (0694–0137). BIS does not believe that                  effectiveness, the resulting delay in
                                                                                                                                                              ■ A. In the table, remove the reserved
                                             this rule will materially increase the                  implementation would afford an
                                                                                                                                                              entry under 0A521 and add in its place
                                             number of submissions under these                       opportunity for the export of these items
                                                                                                                                                              entry No. 1.
                                             collections.                                            to users and uses that pose such a
                                                                                                                                                              ■ B. In the table, remove the reserved
                                                3. This rule does not contain policies               national security threat, thereby
                                                                                                                                                              entry under 0E521 and add in its place
                                             with Federalism implications as that                    undermining the purpose of the rule.
                                                                                                                                                              entry No. 1.
                                             term is defined under E.O. 13132.                       Because a notice of proposed
                                                                                                                                                                The additions read as follows:
                                                4. The provisions of the                             rulemaking and an opportunity for
                                             Administrative Procedure Act (5 U.S.C.                  public comment are not required to be                    Supplement No. 5 to Part 774—Items
                                             553) requiring prior notice, the                        given for this rule by 5 U.S.C. 553, or                  Classified Under ECCNS 0A521, 0B521,
                                             opportunity for public comment and a                    by any other law, the analytical                         0C521, 0D521 AND 0E521
                                             delay in effective date are inapplicable                requirements of the Regulatory                             The following table lists items subject to
                                             because this regulation involves a                      Flexibility Act, 5 U.S.C. 601 et seq., are               the EAR that are not listed elsewhere in the
                                             military or foreign affairs function of the             not applicable. Accordingly, no                          CCL, but which the Department of
                                             United States (See 5 U.S.C. 553(a)(1)).                 regulatory flexibility analysis is required              Commerce, with the concurrence of the
                                                                                                                                                              Departments of Defense and State, has
                                             BIS, with the concurrence of the U.S.                   and none has been prepared. Although                     identified warrant control for export or
                                             Departments of Defense and State, is                    notice and opportunity for comment are                   reexport because the items provide at least a
                                             implementing this rule because the                      not required, BIS is issuing this rule as                significant military or intelligence advantage
                                             items identified for the ECCN 0Y521                     an interim final rule with a request for                 to the United States or for foreign policy
                                             series in this rule provide a significant               comments. All comments must be in                        reasons.

                                                                                                                                   Date when the item
                                                                                                         Date of initial or         will be designated
                                                             Item descriptor                             subsequent BIS           EAR99, unless reclas-
                                               Note: The description must match by model                  classification             sified in another            Item-specific license exception eligibility
                                              number or a broader descriptor that does not            (ID = initial date; SD       ECCN or the 0Y521
                                                necessarily need to be company specific                = subsequent date)            classification is
                                                                                                                                          reissued
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                                                                                                   0A521. Systems, Equipment and Components.

                                             No. 1 Targets made of or containing lithium             August 8, 2016 (ID) ...      August 8, 2017 ..........   License       Exception         GOV         under
                                               ‘‘specially designed’’ for the production of                                                                     § 740.11(b)(2)(ii) only.
                                               tritium by insertion in the core of a nuclear
                                               reactor.




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                                                                Federal Register / Vol. 81, No. 152 / Monday, August 8, 2016 / Rules and Regulations                                                     52329

                                                                                                                                    Date when the item
                                                                                                         Date of initial or          will be designated
                                                             Item descriptor                             subsequent BIS            EAR99, unless reclas-
                                               Note: The description must match by model                  classification              sified in another           Item-specific license exception eligibility
                                              number or a broader descriptor that does not            (ID = initial date; SD        ECCN or the 0Y521
                                                necessarily need to be company specific                = subsequent date)             classification is
                                                                                                                                           reissued

                                                       *                       *                       *                       *                        *                       *                    *

                                                                                                                   0E521. Technology.

                                             No. 1 ‘‘Technology’’ required for the ‘‘develop-        August 8, 2016 (ID) ...       August 8, 2017 ..........   License       Exception        GOV         under
                                               ment’’ or ‘‘production’’ of 0A521 No. 1 items.                                                                    § 740.11(b)(2)(ii) only.



                                               Dated: July 25, 2016.                                 Silver Spring, MD 20993–0002, 240–                        not met a minimum threshold for
                                             Matthew S. Borman,                                      402–7911.                                                 acceptability for FDA review. Under the
                                             Deputy Assistant Secretary for Export                   SUPPLEMENTARY INFORMATION: In the                         rule, FDA will refuse to accept a tobacco
                                             Administration.                                         Federal Register of May 4, 2016 (81 FR                    product submission, for example, that is
                                             [FR Doc. 2016–18070 Filed 8–5–16; 8:45 am]              26687), FDA solicited comments                            not in English, does not pertain to a
                                             BILLING CODE 3510–33–P                                  concerning the direct final rule for a 75-                tobacco product, or does not identify the
                                                                                                     day period ending July 18, 2016. FDA                      type of submission. By refusing to
                                                                                                     stated that the effective date of the                     accept submissions that have the
                                             DEPARTMENT OF HEALTH AND                                direct final rule would be on September                   deficiencies identified in the rule, FDA
                                             HUMAN SERVICES                                          16, 2016, 60 days after the end of the                    will be able to focus our review
                                                                                                     comment period, unless any significant                    resources on submissions that meet a
                                             Food and Drug Administration                            adverse comment was submitted to FDA                      threshold of acceptability and encourage
                                                                                                     during the comment period. FDA did                        quality submissions. FDA is issuing this
                                             21 CFR Part 610                                         not receive any significant adverse                       action directly as a final rule because we
                                                                                                     comments.                                                 believe there is little likelihood that we
                                             [Docket No. FDA–2016–N–1170]                                                                                      will receive any significant adverse
                                                                                                       Authority: Therefore, under the biological
                                             Standard Preparations, Limits of                        products provisions of the Public Health
                                                                                                                                                               comments opposing the rule given the
                                             Potency, and Dating Period Limitations                  Service Act (42 U.S.C. 216, 262, 263, 263a,               specific deficiencies identified that will
                                             for Biological Products; Confirmation                   and 264) and the drugs and general                        result in FDA’s refusal to accept the
                                             of Effective Date                                       administrative provisions of the Federal                  submission.
                                                                                                     Food, Drug, and Cosmetic Act (21 U.S.C. 321,              DATES: This rule is effective December
                                             AGENCY:    Food and Drug Administration,                331, 351, 352, 353, 355, 360, 360c, 360d,
                                                                                                     360h, 360i, 371, 372, 374, and 381), and
                                                                                                                                                               21, 2016. Submit either electronic or
                                             HHS.                                                                                                              written comments on this direct final
                                                                                                     under authority delegated to the
                                             ACTION:  Direct final rule; confirmation of             Commissioner of Food and Drugs, 21 CFR                    rule by October 24, 2016. If we receive
                                             effective date.                                         part 610 is amended. Accordingly, the                     no significant adverse comments during
                                             SUMMARY:   The Food and Drug                            amendments issued thereby are effective.                  the specified comment period, we
                                                                                                       Dated: August 1, 2016.                                  intend to publish a confirmation
                                             Administration (FDA) is confirming the
                                                                                                     Leslie Kux,                                               document on or before the effective date
                                             effective date of September 16, 2016, for
                                                                                                                                                               by publication of a document in the
                                             the final rule that appeared in the                     Associate Commissioner for Policy.
                                                                                                                                                               Federal Register.
                                             Federal Register of May 4, 2016. The                    [FR Doc. 2016–18584 Filed 8–5–16; 8:45 am]
                                             direct final rule amends the general                                                                              ADDRESSES: You may submit comments
                                                                                                     BILLING CODE 4164–01–P
                                             biological products standards relating to                                                                         as follows:
                                             dating periods and removes certain                                                                                Electronic Submissions
                                             standards relating to standard                          DEPARTMENT OF HEALTH AND                                    Submit electronic comments in the
                                             preparations and limits of potency. FDA                 HUMAN SERVICES                                            following way:
                                             is taking this action to update outdated                                                                            • Federal eRulemaking Portal: http://
                                             requirements, and accommodate new                       Food and Drug Administration
                                                                                                                                                               www.regulations.gov. Follow the
                                             and evolving technology and testing                                                                               instructions for submitting comments.
                                             capabilities without diminishing public                 21 CFR Part 1105
                                                                                                                                                               Comments submitted electronically,
                                             health concerns. This action is part of                 [Docket No. FDA–2016–N–1555]                              including attachments, to http://
                                             FDA’s retrospective review of its                                                                                 www.regulations.gov will be posted to
                                             regulations in response to an Executive                 Refuse To Accept Procedures for                           the docket unchanged. Because your
                                             order. This document confirms the                       Premarket Tobacco Product                                 comment will be made public, you are
                                             effective date of the direct final rule.                Submissions                                               solely responsible for ensuring that your
                                             DATES: Effective date of final rule                     AGENCY:    Food and Drug Administration,                  comment does not include any
                                             published in the Federal Register of                    HHS.                                                      confidential information that you or a
                                             May 4, 2016 (81 FR 26687), confirmed:                                                                             third party may not wish to be posted,
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                                                                                                     ACTION:   Direct final rule.
                                             September 16, 2016.                                                                                               such as medical information, your or
                                             FOR FURTHER INFORMATION CONTACT:                        SUMMARY:   The Food and Drug                              anyone else’s Social Security number, or
                                             Tami Belouin, Center for Biologics                      Administration (FDA) is issuing a rule                    confidential business information, such
                                             Evaluation and Research, Food and                       describing when FDA will refuse to                        as a manufacturing process. Please note
                                             Drug Administration, 10903 New                          accept a tobacco product submission (or                   that if you include your name, contact
                                             Hampshire Ave., Bldg. 71, Rm. 7301,                     application) because the application has                  information, or other information that


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Document Created: 2016-08-06 03:08:33
Document Modified: 2016-08-06 03:08:33
CategoryRegulatory Information
CollectionFederal Register
sudoc ClassAE 2.7:
GS 4.107:
AE 2.106:
PublisherOffice of the Federal Register, National Archives and Records Administration
SectionRules and Regulations
ActionInterim final rule with request for comments.
DatesThis rule is effective August 8, 2016. Comments must be received by October 7, 2016.
ContactSteven Clagett, Director, Nuclear and Missile Technology Controls Division, Office of Nonproliferation and Treaty Compliance, by phone at (202) 482-1641, or by email at [email protected] doc.gov.
FR Citation81 FR 52326 
RIN Number0694-AG90
CFR AssociatedExports and Reporting and Recordkeeping Requirements

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