Amendment to the Export Administration Regulations: List of Items Classified Under Export Control Classification 0Y521 Series-Biosensor Systems, 18814-18817 [2013-07132]

Download as PDF 18814 Federal Register / Vol. 78, No. 60 / Thursday, March 28, 2013 / Rules and Regulations Country License review policy Entity License requirement * * * Liberty House Trading LLC, a.k.a. the following two aliases: -Baet Alhoreya Electronics Trading; and -Baet Alhoreya, Apt #1811 Manchester Tower, Dubai Marina, Dubai, U.A.E.; and PO Box 111831, Al Daghaya, Dubai, U.A.E.; and Dubai Shopping Center, Office 13, Dubai, U.A.E. * For all items subject to the EAR. (See § 744.11 of the EAR). * Presumption of denial. * * 78 FR [INSERT FR PAGE NUMBER ] 3/28/13. * * * Moh Khoman, No. 405, Albakhit Centre, Abu-Bakr, AE-Dubai, U.A.E.; and P.O. Box 40150, Al Bakhit Centre, Messanine Floor, M–7, Deira, Dubai, U.A.E.; and Mezzanine Fl, No. M–7, Al Bakhit Centre, AbuBakr Rd, Deira, Dubai, U.A.E. Mohamad Javad, No. 405, Albakhit Centre, Abu-Bakr, AEDubai, U.A.E.; and P.O. Box 40150, Al Bakhit Centre, Messanine Floor, M–7, Deira, Dubai, U.A.E.; and Mezzanine Fl, No. M–7, Al Bakhit Centre, Abu-Bakr Rd, Deira, Dubai, U.A.E. * For all items subject to the EAR. (See § 744.11 of the EAR). * Presumption of denial. * * 78 FR [INSERT FR PAGE NUMBER ] 3/28/13. For all items subject to the EAR. (See § 744.11 of the EAR). Presumption of denial. 78 FR [INSERT FR PAGE NUMBER ] 3/28/13. * * Next Gulf Trading LLC, No. 75 Noor Mohammed Taleb Building, Opposite to Ascot Hotel, Khaleed-bin-Valid Rd, Bur Dubai, Dubai, U.A.E.; and No. 7 Noor Mohammad Taleb Bldg. Opp. Ascot Hotel Khalid Bin Rd, Dubai, U.A.E.; and No. 705, Noor Mohammad Taleb Bldg, Bin Valid Road, Dubai, U.A.E.; and P.O. Box 122114, Dubai, U.A.E.; and P.O. 111837, Dubai, U.A.E. * For all items subject to the EAR. (See § 744.11 of the EAR). * Presumption of denial. * * 78 FR [INSERT FR PAGE NUMBER ] 3/28/13. * * * * Dated: March 21, 2013. Kevin J. Wolf, Assistant Secretary for Export Administration. * * DEPARTMENT OF COMMERCE Bureau of Industry and Security [FR Doc. 2013–07135 Filed 3–27–13; 8:45 am] 15 CFR Part 774 [Docket No. 121025585–3248–01] BILLING CODE 3510–33–P RIN 0694–AF73 srobinson on DSK4SPTVN1PROD with RULES Amendment to the Export Administration Regulations: List of Items Classified Under Export Control Classification 0Y521 Series— Biosensor Systems Bureau of Industry and Security, Commerce. ACTION: Interim final rule with request for comments. AGENCY: SUMMARY: In this interim final rule, the Bureau of Industry and Security (BIS) VerDate Mar<15>2010 17:43 Mar 27, 2013 Jkt 229001 PO 00000 Frm 00020 Fmt 4700 Federal Register citation Sfmt 4700 * * 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 specified biosensor systems, ‘‘software’’ and ‘‘technology’’ under Export Control Classification Numbers (ECCNs) 0A521, 0D521 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 (77 FR 22191), 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, that the items should E:\FR\FM\28MRR1.SGM 28MRR1 Federal Register / Vol. 78, No. 60 / Thursday, March 28, 2013 / Rules and Regulations srobinson on DSK4SPTVN1PROD with RULES 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. 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 official use by personnel and agencies of the U.S. Government. DATES: This rule is effective March 28, 2013. Comments must be received by May 28, 2013. 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– 2013–0007. • By email directly to: publiccomments@bis.doc.gov. Include RIN 0694–AF73 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–AF73. FOR FURTHER INFORMATION CONTACT: Elizabeth Sangine, Director, Chemical and Biological Controls Division, Office of Nonproliferation and Treaty Compliance by phone at (202) 482–3343 or by email at Elizabeth.Scottsangine@bis.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. Items are added to the ECCN 0Y521 series by the Department of Commerce, with the concurrence of the Departments of Defense and State, 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. The ECCN 0Y521 series is a temporary holding classification equivalent to United States Munitions List (USML) Category XXI (Miscellaneous Articles) in part 121 of the International Traffic in Arms Regulations, but 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), 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 VerDate Mar<15>2010 17:43 Mar 27, 2013 Jkt 229001 interim final rule as 0A521, 0D521 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 Australia 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 ECCNs 0Y521 series appear in § 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-bycase 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 applicable to all ECCN 0Y521 series items, including those items identified in this notice, if the item is within the scope of § 740.11(b)(2)(ii) (Items for official use by personnel and agencies of the U.S. Government), as provided in § 740.2(a)(14). License Exception GOV is the only license exception that can be used for the items identified in this interim final rule. Addition of ECCN 0A521, 0D521 and 0E521 Items In this rule, BIS amends the EAR to make specified biosensor systems, and related ‘‘software,’’ and ‘‘technology’’ subject to the EAR and impose license PO 00000 Frm 00021 Fmt 4700 Sfmt 4700 18815 requirements on these 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 State and Defense, that these 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. The specified biosensor systems, ‘‘software,’’ and ‘‘technology’’ are classified under ECCNs 0A521, 0D521 and 0E521, respectively. A brief description of each of these items and ECCNs follows. ECCN 0A521 covers biosensor systems and dedicated detecting components capable of detecting certain aerosolized bioagents and having the following characteristics: capable of showing results in three minutes or less; containing an integrated bioaerosol collector and identifier; containing antibodies to the bioagents listed in the entry; and utilizing bioluminescence as a process. This entry also includes a Related Controls paragraph that differentiates ECCNs 1A004.c detection systems and 2B351 toxic gas monitoring systems and their dedicated detecting components controls on the CCL from 0A521 Biosensor Systems. That paragraph also refers exporters to USML Category XIV(f)(2) for equipment for the detection, identification, warning or monitoring of biological agents that is subject to the licensing jurisdiction of the Department of State, Directorate of Defense Trade Controls. Finally, two Technical Notes are provided for this entry defining the term ‘dedicated’ and clarifying that the entry does not control biosensor systems that detect foodborne pathogens. 0D521 is ‘‘Software’’ for the function of biosensor systems controlled by ECCN 0A521. 0E521 is ‘‘Technology’’ for the ‘‘development’’ or ‘‘production’’ of biosensor systems controlled by ECCN 0A521. The technical descriptions and the status of the specified items appear in the table found in Supplement No. 5 to part 774 of the EAR. License Applications for the New ECCN 0A521, 0D521 and 0E521 Items License applications for these items may be submitted through SNAP–R in accordance with § 748.6 of the EAR. Exporters are directed to include detailed descriptions and technical specifications with the license application, and identify the hardware as ECCN 0A521, the ‘‘software’’ as ECCN 0D521, and the ‘‘technology’’ as ECCN 0E521. E:\FR\FM\28MRR1.SGM 28MRR1 18816 Federal Register / Vol. 78, No. 60 / Thursday, March 28, 2013 / Rules and Regulations This 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 to the Government on the ultimate nature of export controls on these items. 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 extended by the Notice of August 15, 2012, 77 FR 49699 (August 16, 2012), 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. srobinson on DSK4SPTVN1PROD with RULES Rulemaking Requirements 1. Executive Orders 13563 and 12866 direct agencies to assess all 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, 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) VerDate Mar<15>2010 19:28 Mar 27, 2013 Jkt 229001 License Exceptions and Exclusions (0694–0137). With these initial 0Y521 series items, 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 USC 553(d)(3). 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 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. PO 00000 Frm 00022 Fmt 4700 Sfmt 4700 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. 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] 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; 30 U.S.C. 185(s), 185(u); 42 U.S.C. 2139a; 42 U.S.C. 6212; 43 U.S.C. 1354; 15 U.S.C. 1824a; 50 U.S.C. app. 5; 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 15, 2012, 77 FR 49699 (August 16, 2012). 2. Supplement No. 5 to Part 774 is revised to 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. E:\FR\FM\28MRR1.SGM 28MRR1 Federal Register / Vol. 78, No. 60 / Thursday, March 28, 2013 / Rules and Regulations Date of initial or subsequent BIS classification. (ID = initial date; SD = subsequent date) Item descriptor Note: The description must match by model number or a broader descriptor that does not necessarily need to be company specific Date when the item will be designated EAR99, unless reclassified in another ECCN or the 0Y521 classification is reissued 18817 Item-specific license exception eligibility 0A521. Systems, Equipment and Components No.1: Biosensor systems and dedicated detecting components, i.e. cartridges and cells, capable of detecting all of the following aerosolized bioagents: anthrax, ricin, Botulinum toxin, Francisella tularensis, orthopoxvirus and Yersinia pestis, and having all of the following characteristics: a. Capable of showing results in three minutes or less; b. Has an integrated bioaerosol collector and identifier; c. Contains antibodies for any of the bioagents listed above; and d. Utilizes bioluminescence as a process. Related Controls. (1) See ECCN 1A004.c for detection systems and ECCN 2B351 for toxic gas monitoring systems and their dedicated detecting components, both of which are different from ECCN 0A521. Biosensor Systems. (2) See 22 CFR Part 121, Category XIV (f) (2) for equipment for the detection, identification, warning or monitoring of biological agents that is subject to the export licensing jurisdiction of the U.S. Department of State, Directorate of Defense Trade Controls. Technical Notes: 1. For the purposes of this entry, the term dedicated means committed entirely to a single purpose or device. 2. This entry does not control biosensor systems that detect food borne pathogens. March 28, 2013 (ID) ...... March 28, 2014 ............. License Exception GOV under § 740.11(b)(2)(ii) only. 0B521. Test, Inspection and Production Equipment [RESERVED]. 0C521. Materials [RESERVED]. 0D521. Software No. 1 0D521 ‘‘Software’’ for the function of Biosensor Systems controlled by ECCN 0A521. March 28, 2013 (ID) ...... March 28, 2014 ............. License Exception GOV under § 740.11(b)(2)(ii) only. March 28, 2014 ............. License Exception GOV under § 740.11(b)(2)(ii) only. 0E521. Technology No. 1: 0E521 ‘‘Technology’’ for the ‘‘development’’ or ‘‘production’’ of Biosensor Systems controlled by ECCN 0A521. Dated: March 21, 2013. Kevin J. Wolf, Assistant Secretary for Export Administration. March 28, 2013 (ID) ...... DEPARTMENT OF ENERGY Federal Energy Regulatory Commission [FR Doc. 2013–07132 Filed 3–27–13; 8:45 am] BILLING CODE 3510–33–P 18 CFR Part 40 [Docket No. RM12–4–000; Order No. 777] srobinson on DSK4SPTVN1PROD with RULES Revisions to Reliability Standard for Transmission Vegetation Management Federal Energy Regulatory Commission. ACTION: Final rule. AGENCY: SUMMARY: Under section 215 of the Federal Power Act (FPA), the Federal Energy Regulatory Commission (Commission) approves Reliability VerDate Mar<15>2010 17:43 Mar 27, 2013 Jkt 229001 PO 00000 Frm 00023 Fmt 4700 Sfmt 4700 Standard FAC–003–2 (Transmission Vegetation Management), submitted to the Commission for approval by the North American Electric Reliability Corporation (NERC), the Commissioncertified Electric Reliability Organization. Reliability Standard FAC– 003–2 expands the applicability of the standard to include overhead transmission lines that are operated below 200 kV, if they are either an element of an Interconnection Reliability Operating Limit or an element of a Major WECC Transfer Path. Reliability Standard FAC–003–2 incorporates a new minimum annual inspection requirement, and incorporates new minimum vegetation E:\FR\FM\28MRR1.SGM 28MRR1

Agencies

[Federal Register Volume 78, Number 60 (Thursday, March 28, 2013)]
[Rules and Regulations]
[Pages 18814-18817]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: 2013-07132]


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DEPARTMENT OF COMMERCE

Bureau of Industry and Security

15 CFR Part 774

[Docket No. 121025585-3248-01]
RIN 0694-AF73


Amendment to the Export Administration Regulations: List of Items 
Classified Under Export Control Classification 0Y521 Series--Biosensor 
Systems

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 specified biosensor systems, 
``software'' and ``technology'' under Export Control Classification 
Numbers (ECCNs) 0A521, 0D521 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 (77 FR 22191), 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, that the items should

[[Page 18815]]

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. 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 official use by 
personnel and agencies of the U.S. Government.

DATES: This rule is effective March 28, 2013. Comments must be received 
by May 28, 2013.

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-2013-0007.
     By email directly to: publiccomments@bis.doc.gov. Include 
RIN 0694-AF73 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-AF73.

FOR FURTHER INFORMATION CONTACT: Elizabeth Sangine, Director, Chemical 
and Biological Controls Division, Office of Nonproliferation and Treaty 
Compliance by phone at (202) 482-3343 or by email at 
Elizabeth.Scottsangine@bis.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. Items are added to the ECCN 0Y521 series by the Department of 
Commerce, with the concurrence of the Departments of Defense and State, 
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. The ECCN 0Y521 series is a temporary holding classification 
equivalent to United States Munitions List (USML) Category XXI 
(Miscellaneous Articles) in part 121 of the International Traffic in 
Arms Regulations, but 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), 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, 0D521 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 Australia 
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 ECCNs 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 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) (Items for 
official use by personnel and agencies of the U.S. Government), as 
provided in Sec.  740.2(a)(14). License Exception GOV is the only 
license exception that can be used for the items identified in this 
interim final rule.

Addition of ECCN 0A521, 0D521 and 0E521 Items

    In this rule, BIS amends the EAR to make specified biosensor 
systems, and related ``software,'' and ``technology'' subject to the 
EAR and impose license requirements on these 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 
State and Defense, that these 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. The 
specified biosensor systems, ``software,'' and ``technology'' are 
classified under ECCNs 0A521, 0D521 and 0E521, respectively. A brief 
description of each of these items and ECCNs follows.
    ECCN 0A521 covers biosensor systems and dedicated detecting 
components capable of detecting certain aerosolized bioagents and 
having the following characteristics: capable of showing results in 
three minutes or less; containing an integrated bioaerosol collector 
and identifier; containing antibodies to the bioagents listed in the 
entry; and utilizing bioluminescence as a process. This entry also 
includes a Related Controls paragraph that differentiates ECCNs 1A004.c 
detection systems and 2B351 toxic gas monitoring systems and their 
dedicated detecting components controls on the CCL from 0A521 Biosensor 
Systems. That paragraph also refers exporters to USML Category 
XIV(f)(2) for equipment for the detection, identification, warning or 
monitoring of biological agents that is subject to the licensing 
jurisdiction of the Department of State, Directorate of Defense Trade 
Controls. Finally, two Technical Notes are provided for this entry 
defining the term `dedicated' and clarifying that the entry does not 
control biosensor systems that detect foodborne pathogens.
    0D521 is ``Software'' for the function of biosensor systems 
controlled by ECCN 0A521.
    0E521 is ``Technology'' for the ``development'' or ``production'' 
of biosensor systems controlled by ECCN 0A521.
    The technical descriptions and the status of the specified items 
appear in the table found in Supplement No. 5 to part 774 of the EAR.

License Applications for the New ECCN 0A521, 0D521 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 hardware as ECCN 0A521, the 
``software'' as ECCN 0D521, and the ``technology'' as ECCN 0E521.

[[Page 18816]]

    This 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 
to the Government on the ultimate nature of export controls on these 
items.
    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 extended by the Notice of August 15, 
2012, 77 FR 49699 (August 16, 2012), 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.

Rulemaking Requirements

    1. Executive Orders 13563 and 12866 direct agencies to assess all 
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, 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). With these initial 0Y521 series 
items, 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 USC 553(d)(3). 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 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. 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; 30 U.S.C. 185(s), 185(u); 42 U.S.C. 2139a; 42 
U.S.C. 6212; 43 U.S.C. 1354; 15 U.S.C. 1824a; 50 U.S.C. app. 5; 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 15, 2012, 77 FR 49699 (August 16, 2012).

0
2. Supplement No. 5 to Part 774 is revised to 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.

[[Page 18817]]



----------------------------------------------------------------------------------------------------------------
                                                                 Date when the item will
Item descriptor  Note: The description     Date of initial or     be designated  EAR99,
    must match by model number or a          subsequent BIS       unless reclassified in
   broader descriptor that does not      classification.  (ID =    another ECCN or the     Item-specific license
    necessarily need to be company         initial date; SD =    0Y521 classification is   exception eligibility
               specific                     subsequent date)             reissued
 
----------------------------------------------------------------------------------------------------------------
                                    0A521. Systems, Equipment and Components
----------------------------------------------------------------------------------------------------------------
No.1: Biosensor systems and dedicated   March 28, 2013 (ID)....  March 28, 2014.........  License Exception GOV
 detecting components, i.e. cartridges                                                     under Sec.
 and cells, capable of detecting all                                                       740.11(b)(2)(ii)
 of the following aerosolized                                                              only.
 bioagents: anthrax, ricin,
Botulinum toxin, Francisella
 tularensis, orthopoxvirus and
 Yersinia pestis, and having all of
 the following characteristics:.
    a. Capable of showing results in
     three minutes or less;
    b. Has an integrated bioaerosol
     collector and identifier;
    c. Contains antibodies for any of
     the bioagents listed above; and
    d. Utilizes bioluminescence as a
     process.
Related Controls. (1) See ECCN 1A004.c
 for detection systems and ECCN 2B351
 for toxic gas monitoring systems and
 their dedicated detecting components,
 both of which are different from ECCN
 0A521.
Biosensor Systems. (2) See 22 CFR Part
 121, Category XIV (f) (2) for
 equipment for the detection,
 identification, warning or monitoring
 of biological agents that is subject
 to the export licensing jurisdiction
 of the U.S. Department of State,
 Directorate of Defense Trade
 Controls.
Technical Notes:
    1. For the purposes of this entry,
     the term dedicated means
     committed entirely to a single
     purpose or device.
    2. This entry does not control
     biosensor systems that detect
     food borne pathogens.
----------------------------------------------------------------------------------------------------------------
                                0B521. Test, Inspection and Production Equipment
----------------------------------------------------------------------------------------------------------------
[RESERVED]............................
----------------------------------------------------------------------------------------------------------------
                                                0C521. Materials
----------------------------------------------------------------------------------------------------------------
[RESERVED]............................
----------------------------------------------------------------------------------------------------------------
                                                 0D521. Software
----------------------------------------------------------------------------------------------------------------
No. 1 0D521 ``Software'' for the        March 28, 2013 (ID)....  March 28, 2014.........  License Exception GOV
 function of Biosensor Systems                                                             under Sec.
 controlled by ECCN 0A521.                                                                 740.11(b)(2)(ii)
                                                                                           only.
----------------------------------------------------------------------------------------------------------------
                                                0E521. Technology
----------------------------------------------------------------------------------------------------------------
No. 1: 0E521 ``Technology'' for the     March 28, 2013 (ID)....  March 28, 2014.........  License Exception GOV
 ``development'' or ``production'' of                                                      under Sec.
 Biosensor Systems controlled by ECCN                                                      740.11(b)(2)(ii)
 0A521.                                                                                    only.
----------------------------------------------------------------------------------------------------------------


    Dated: March 21, 2013.
Kevin J. Wolf,
Assistant Secretary for Export Administration.
[FR Doc. 2013-07132 Filed 3-27-13; 8:45 am]
BILLING CODE 3510-33-P