82 FR 61153 - Revisions, Clarifications, and Technical Corrections to the Export Administration Regulations
DEPARTMENT OF COMMERCE
Bureau of Industry and Security Federal Register Volume 82, Issue 247 (December 27, 2017)
Bureau of Industry and Security
Federal Register Volume 82, Issue 247 (December 27, 2017)
| Page Range | 61153-61162 | |
| FR Document | 2017-27616 |
[Federal Register Volume 82, Number 247 (Wednesday, December 27, 2017)] [Rules and Regulations] [Pages 61153-61162] From the Federal Register Online [www.thefederalregister.org] [FR Doc No: 2017-27616] ======================================================================= ----------------------------------------------------------------------- DEPARTMENT OF COMMERCE Bureau of Industry and Security 15 CFR Parts 732, 734, 738, 740, 746, and 774 [170207157-7157-01] RIN 0694-AH31 Revisions, Clarifications, and Technical Corrections to the Export Administration Regulations AGENCY: Bureau of Industry and Security, Commerce. ACTION: Final rule; correcting amendments. ----------------------------------------------------------------------- SUMMARY: In this final rule, the Bureau of Industry and Security corrects certain provisions in the Export Administration Regulations (EAR) to provide accurate references and fix typographical errors, and amend several Export Control Classification Numbers (ECCNs) to enhance consistency with the other ECCNs on the Commerce Control List (CCL). The corrections are editorial in nature and do not affect license requirements. DATES: This rule is effective December 27, 2017. FOR FURTHER INFORMATION CONTACT: Ivan Mogensen, Office of Exporter Services, Bureau of Industry and Security, by telephone: (202) 482-2440 or email: Ivan.Mogensen@bis.doc.gov. SUPPLEMENTARY INFORMATION: Overview This final rule updates six parts of the EAR to correct typographical errors, clarify inaccurate or unclear internal references, and correct inconsistencies in certain entries on the Commerce Control List (CCL). Part 732 Section 732.4(b) discusses steps to be taken when reviewing license exceptions for exports and reexports. In Sec. 732.4(b)(7)(ii), there is a reference to Sec. 740.20(g) listing ECCNs that may be eligible for subsequent export or reexport under license exception STA, following submission of a license application. However, only ECCN 9A610.a is listed in Sec. 732.4(b)(7)(ii), while ECCNs 0A606.a, 8A609.a, 8A620.a, 8A620.b, ``spacecraft'' in ECCN subparagraphs 9A515.a.1, a.2, a.3, a.4, 9A515.g, and 9E515.b, .d, .e, and .f (which also now appear in Sec. 740.20(g)), are inadvertently omitted. This correction adds the omitted items listed in Sec. 740.20(g) to Sec. 732.4(b)(7)(ii). Additionally, because these items include both commodities and technology, the term ``aircraft'' in the reference to 9A610.a is replaced with ``item.'' This rule also clarifies and corrects the Export Control Decision Tree diagram in supplement No. 1 to part 732 that was last revised in a final rule published February 6, 2004 (69 FR 5686 (Feb. 6, 2004)). Several of the decision ``blocks'' in the flowchart contain references that are unclear or incorrect. This rule provides clarity by changing references to the general prohibitions to citations of specific sections of the EAR, and correcting improper citations to ensure that the citations contained in all decision blocks coincide with the appropriate sections of the EAR. Specifically, the changes are as follows: In the block which begins ``Is your item classified under an ECCN on the CCL,'' a direct citation to Sec. 736.2(b)(1) through (3) replaces a reference to General Prohibitions 1 through 3, which did not inform the reader where the prohibitions could be found in the EAR; in the block which begins ``Is there an `X' in the box,'' the EAR citations now directly follow references to the Commerce Country Chart and the CCL, respectively; and, in the block which begins ``Use License Exception,'' the citation to Sec. 740.1, which is an introduction, is replaced with a reference to the whole of part 740. Additionally, several grammatical errors are addressed, and the section symbol (``Sec. '') is added wherever a section of the EAR is referenced in the decision blocks for clarity. Finally, this final rule changes the supplement's name from ``Decision Tree'' to ``Export Control Decision Tree'' to match the title of the diagram, and the duplicative parenthetical in the graphic title reading ``(Supp. No. 1 to Part 732)'' is deleted. Part 734 Section 734.18 was created in the rule Revisions to Definitions in the Export Administration Regulations (81 FR 35586 (June 3, 2016)) and discusses activities that are not exports, reexports, or transfers. The note following the end of Sec. 734.18(a)(5)(iv) discusses data in transit via the internet, but the note is incorrectly described as the note to paragraph (a)(4)(iv). This rule changes the note to refer to Sec. 734.18(a)(5)(iv). Part 738 In Sec. 738.2(d)(1), Composition of an entry, there is a description of the meaning attached to each alphanumeric character making up an Export Control Classification Number. This paragraph currently explains that the second ``digit'' in an ECCN indicates the ``Reason for Control.'' However, in paragraph (d)(1)(i) of this section, the paragraph refers to the Reason for Control as the third ``digit.'' This final rule amends Sec. 738.2(d)(1)(i) to replace the word ``digit'' with ``alphanumeric character'' in order to maintain consistency and prevent confusion. Additionally, in Sec. 738.2, this final rule makes a correction in Sec. 738.2(d)(2)(iv)(C)(2). The text of this paragraph uses ECCN 2B992 as an example when providing an overview of how to read an ECCN heading on the Commerce Control List (CCL). However, in the latter part of the section, the text erroneously references ECCN 2B999 instead of 2B992. This rule replaces the reference to ECCN 2B999 with 2B992 in this section to correct the ECCN reference. Part 740 Section 740.20(g)(1) lists 9x515 and ``600 series'' ECCNs that are eligible for license exception Strategic Trade Authorization. This includes ECCNs 9A515.a.1, .a.2, .a.3, .a.4, and .g, 9A610.a, and technology ECCNs 9E515.b, .d, .e, and .f. In the final rule Revisions to the Export Administration Regulations (EAR): Control of Spacecraft Systems and Related Items the President Determines No Longer Warrant Control under the United States Munitions List (USML) (82 FR 2875 (Jan. 10, 2017)), the phrase ``that provide space-based logistics, assembly or servicing of any spacecraft (e.g., refueling)'' following the list of ECCN [[Page 61154]] 9A515 items paragraphs was intended to be removed since it is only applicable to 9A515.a.4 and not to the other ECCNs. Since the phrase was not removed, this rule removes the phrase to prevent confusion by users. Part 746 This rule amends Sec. 746.9(a) by removing an outdated reference to Sec. 734.2(b) for the definitions of ``deemed export'' and ``deemed reexport,'' as that section is currently reserved, and replacing it with references to Sec. Sec. 734.13(b) and 734.14(b), because the relevant definitions for deemed ``export'' and deemed ``reexport'' has been found in those two sections of the EAR since the publication of the final rule Revisions to Definitions in the Export Administration Regulations (81 FR 35586). Additionally, consistent with the guidance in Sec. 774.1(d), the double quotes around deemed export and deemed reexport in Sec. 746.9 are removed as these terms do not appear in Sec. 772.1. Part 774 This rule makes corrections to six ECCNs in supplement No. 1 to part 774, ``Commerce Control List,'' by correcting misspellings and creating conforming changes. The corrections are as follows: ECCNs 0A606, 8A609, and 9A610: This final rule amends these ECCNs to correct the title of Sec. 740.20(g) that is referenced in paragraph (1) in the Special Conditions for STA section of the ECCN entries. Currently, these sections refer to Sec. 740.20(g) as License Exception STA eligibility requests for ``600 series'' end items, when the current title for this section is License Exception STA eligibility requests for 9x515 and ``600 series'' items. The title of Sec. 740.20(g) was changed in the rule Revisions to the Export Administration Regulations (EAR): Control of Spacecraft Systems and Related Items the President Determines No Longer Warrant Control Under the United States Munitions List (USML); (79 FR 27417 (May 13, 2014)), but the change was not made to the corresponding ECCNs. This rule amends the title reference in these ECCNs to match the current title of Sec. 740.20(g). ECCNs 0D606.a and 0E606.a: This final rule amends ECCN subparagraphs 0D606.a and 0E606.a to include references to ECCNs 0B606 and 0C606. The headings of both 0D606 and 0E606 refer to 0B606 and 0C606 but these references do not appear in Items paragraph .a of the List of Items Controlled section. This inconsistency has generated confusion as to whether 0D606.a software ``specially designed'' for the ``development,'' ``production,'' operation or maintenance of the items controlled under ECCNs 0B606 and 0C606 or 0E606.a technology required for the ``development,'' ``production,'' operation or maintenance of the items controlled under ECCNs 0B606 and 0C606 is controlled or not. This edit removes this confusion by clarifying that such software is controlled under ECCN 0D606.a and such technology is controlled under ECCN 0E606.a. ECCN 2B352: This final rule corrects ECCN 2B352 by revising, in the List of Items Controlled section, Items paragraphs g.1, i.1, i.2 and i.3 and the Technical Notes at the end of the Items paragraphs. The corrections are as follows: The word ``dependant'' is replaced with the American spelling of the word ``dependent'' in Items paragraph g.1; double quotes are added around the term ``aircraft'' in Items paragraphs i.1 and i.2, and in Technical Notes 1 and 3 because ``aircraft'' is a defined term in the EAR; double quotes are added around the term ``laser'' in Technical Notes 3.a and .b for the same reason; double quotes are replaced with single quotes around the term `VMD' in Items paragraphs i.1 and i.2 and the term is clarified in Technical Note 3; single quotes are added to the term `aerosol generating units' in Items paragraphs i.2 and i.3 and Technical Note 1. ECCN 8A609: This final rule revises Related Control paragraph (3) under the List of Items Controlled section in ECCN 8A609 to add a reference to Category VI of the International Traffic in Arms Regulations (ITAR). This is done to indicate that certain diesel engines and electric motors for both EAR surface vessels of war and ITAR surface vessels of war are controlled under ECCN 8A992.g. Additionally, double quotes are added around the term ``subject to the EAR'' because it is a defined term in the EAR. Export Administration Act Since August 21, 2001, the Export Administration Act of 1979, as amended, has been in lapse. However, 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 15, 2017, 82 FR 39005 (August 16, 2017) has continued the EAR in effect under the International Emergency Economic Powers Act (50 U.S.C. 1701 et seq.). 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 alternatives and, if regulation is necessary, to select regulatory approaches that maximize net benefits (including potential economic, environmental, public health and safety effects, distributive impacts, and equity). Executive Order 13563 emphasizes the importance of quantifying both costs and benefits, of reducing costs, of harmonizing rules, and of promoting flexibility. This rule does not impose any regulatory burden on the public and is consistent with the goals of Executive Order 13563. This rule has been designated not significant for purposes of Executive Order 12866. This rule is not an Executive Order 13771 regulatory action because this rule is not significant under Executive Order 12866. 2. This final rule does not contain information collections subject to the requirements of the Paperwork Reduction Act of 1995 (44 U.S.C. 3501 et seq.) (PRA). 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 Office of Management and Budget (OMB) Control Number. 3. This rule does not contain policies with Federalism implications as that term is defined in Executive Order 13132. 4. The Department of Commerce finds that there is good cause under 5 U.S.C. 553(b)(B) to waive the provisions of the Administrative Procedure Act otherwise requiring prior notice and the opportunity for public comment because they are unnecessary. The revisions made by this rule are administrative in nature and do not affect the privileges and obligations of the public. Additionally, it is important that the edits and clarifications are added as soon as possible to prevent improper interpretation of the EAR. The Department also finds that there is good cause under 5 U.S.C. 553(b)(A) to waive the provisions of the Administrative Procedure Act requiring notice and comment because these changes are limited to providing guidance on existing interpretations of current EAR provisions. Because these revisions are not substantive changes to the EAR, the [[Page 61155]] 30-day delay in effectiveness otherwise required by 5 U.S.C. 553(d) is not applicable. No other law requires that a notice of proposed rulemaking and opportunity for public comment be given for this rule. The analytical requirements of the Regulatory Flexibility Act (5 U.S.C. 601 et seq.) are not applicable because no general notice of proposed rulemaking was required for this rule by 5 U.S.C. 553, or by any other law. Accordingly, no regulatory flexibility analysis is required and none has been prepared. List of Subjects 15 CFR Part 732 Administrative practice and procedure, Exports, Reporting and recordkeeping requirements 15 CFR Part 734 Administrative practice and procedure, Exports, Inventions and patents, Research, Science and technology 15 CFR Part 738 Exports 15 CFR Part 740 Administrative practice and procedure, Exports, Reporting and recordkeeping requirements. 15 CFR Parts 746 and 774 Exports, Reporting and recordkeeping requirements. Accordingly, parts 732, 734, 738, 740, 746, and 774 of the Export Administration Regulations (15 CFR parts 730 through 774) are amended as follows: PART 732--[AMENDED] 0 1. The authority citation for 15 CFR part 732 continues to read as follows: Authority: 50 U.S.C. 4601 et seq.; 50 U.S.C. 1701 et seq.; 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, 2017, 82 FR 39005 (August 16, 2017). 0 2. Section 732.4 is amended by revising paragraph (b)(7)(ii) to read as follows: Sec. 732.4 Steps regarding License Exceptions. * * * * * (b) * * * (7) * * * (ii) If you are going to file a license application with BIS for the export, reexport, or in-country transfer for aircraft or military vessels controlled under ECCNs 0A606.a, 8A609.a, 8A620.a, 8A620.b, certain ``spacecraft'' controlled under ECCN subparagraphs 9A515.a.1, a.2, a.3, a.4 or 9A515.g, ECCN 9A610.a, or technology under ECCNs 9E515.b, .d, .e, or .f, Sec. 740.20(g) permits you to request in the application that subsequent exports of the type of aircraft, spacecraft, military vessels, or technology at issue be eligible for export under License Exception STA. The types of ``items'' controlled under ECCNs 0A606.a, 8A609.a, 8A620.a, 8A620.b, certain spacecraft controlled under ECCN subparagraphs 9A515.a.1, a.2, a.3, a.4 or 9A515.g, ECCN 9A610.a, and technology ECCNs 9E515.b, .d, .e, or .f, that have been determined to be eligible for License Exception STA pursuant to Sec. 740.20(g) are identified in the License Exceptions paragraphs of ECCNs 0A606, 8A609, 8A620, 9A610, 9A515, and 9E515. Supplement No. 2 to part 748, paragraph (w) (License Exception STA eligibility requests), contains the instructions for such applications. Note 1 to paragraph (b)(7)(ii): If you intend to use License Exception STA, return to paragraphs (a) and then (b) of this section to review the Steps regarding the use of license exceptions. * * * * * 0 3. Supplement No. 1 to part 732 is revised to read as follows: BILLING CODE 3510-33-P [[Page 61156]] [GRAPHIC] [TIFF OMITTED] TR27DE17.004 BILLING CODE 3510-33-C PART 734--[AMENDED] 0 4. The authority citation for 15 CFR part 734 continues to read as follows: Authority: 50 U.S.C. 4601 et seq.; 50 U.S.C. 1701 et seq.; E.O. 12938, 59 FR 59099, 3 CFR, 1994 Comp., p. 950; E.O. 13020, 61 FR 54079, 3 CFR, 1996 Comp., p. 219; E.O. 13026, 61 FR 58767, 3 CFR, 1996 Comp., p. 228; E.O. 13222, 66 FR 44025, 3 CFR, 2001 Comp., p. 783; E.O. 13637, 78 FR 16129, 3 CFR, 2014 Comp., p. 223; Notice of November 8, 2016, 81 FR 79379 (November 10, 2016); Notice of August 15, 2017, 82 FR 39005 (August 16, 2017). Sec. 734.18 [Amended] 0 5. Section 734.18 is amended by redesignating the note to paragraph (a)(4)(iv) as note 1 to paragraph (a)(5)(iv). PART 738--[AMENDED] 0 6. The authority citation for 15 CFR part 738 continues to read as follows: Authority: 50 U.S.C. 4601 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; 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 15, 2017, 82 FR 39005 (August 16, 2017). 0 7. Section 738.2 is amended by revising paragraphs (d)(1)(i) and (d)(2)(iv)(C)(2) to read as follows: Sec. 738.2 Commerce Control List (CCL) structure. * * * * * (d) * * * (1) * * * (i) Since Reasons for Control are not mutually exclusive, numbers are assigned in order of precedence. As an [[Page 61157]] example, if an item is controlled for both National Security and Missile Technology reasons, the entry's third alphanumeric character will be a ``0''. If the item is controlled only for Missile Technology the third alphanumeric character will be ``1''. (2) * * * (iv) * * * (C) * * * (2) ``(See List of Items Controlled)'' is in the middle of the ECCN heading. If the phrase ``(see List of Items Controlled)'' appears in the middle of the ECCN heading, then all portions of the heading that follow the phrase ``(see List of Items Controlled)'' will list items controlled in addition to the list in the ``items'' paragraph. An example of such a heading is ECCN 2B992 Non-``numerically controlled'' machine tools for generating optical quality surfaces, (see List of Items Controlled) and ``specially designed'' ``parts'' and ``components'' therefor. Under the ECCN 2B992 example, the ``items'' paragraph must be reviewed to determine whether your item is contained within the first part of the heading (``non-`numerically controlled' machine tools for generating optical quality surfaces'') and classified under 2B992. The second part of the ECCN 2B992 heading (``and `specially designed' `parts' and `components' therefor'') contains the exclusive list described in the heading. ECCNs 1A006, 3B992, 4A001, 6A006 and 7A001 are other examples where the phrase ``(see List of Items Controlled)'' appears in the middle of the ECCN heading. * * * * * PART 740--[AMENDED] 0 8. The authority citation for 15 CFR part 740 continues to read as follows: Authority: 50 U.S.C. 4601 et seq.; 50 U.S.C. 1701 et seq.; 22 U.S.C. 7201 et seq.; 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, 2017, 82 FR 39005 (August 16, 2017). 0 9. Section 740.20 is amended by revising paragraph (g)(1) to read as follows: Sec. 740.20 License Exception Strategic Trade Authorization (STA). * * * * * (g) * * * (1) Applicability. Any person may request License Exception STA eligibility for end items described in ECCN 0A606.a, ECCN 8A609.a, ECCNs 8A620.a or .b, ``spacecraft'' in ECCNs 9A515.a.1, .a.2, .a.3, .a.4, or .g, 9A610.a, or technology ECCNs 9E515.b, .d, .e, or .f. * * * * * PART 746--[AMENDED] 0 10. The authority citation for 15 CFR part 746 is revised to read as follows: Authority: 50 U.S.C. 4601 et seq.; 50 U.S.C. 1701 et seq.; 22 U.S.C. 287c; Sec 1503, Pub. L. 108-11, 117 Stat. 559; 22 U.S.C. 6004; 22 U.S.C. 7201 et seq.; 22 U.S.C. 7210; E.O. 12854, 58 FR 36587, 3 CFR, 1993 Comp., p. 614; E.O. 12918, 59 FR 28205, 3 CFR, 1994 Comp., p. 899; E.O. 13222, 66 FR 44025, 3 CFR, 2001 Comp., p. 783; E.O. 13338, 69 FR 26751, 3 CFR, 2004 Comp., p 168; Presidential Determination 2003-23, 68 FR 26459, 3 CFR, 2004 Comp., p. 320; Presidential Determination 2007-7, 72 FR 1899, 3 CFR, 2006 Comp., p. 325; Notice of August 15, 2017, 82 FR 39005 (August 16, 2017); Notice of May 9, 2017, 82 FR 21909 (May 10, 2017). 0 9. Section 746.9 is amended by revising paragraph (a) to read as follows: Sec. 746.9 Syria. * * * * * (a) License requirements. A license is required for the export or reexport to Syria of all items subject to the EAR, except food and medicine classified as EAR99 (food and medicine are defined in part 772 of the EAR). A license is required for the deemed export and deemed reexport, as described in Sec. Sec. 734.13(b) and 734.14(b) of the EAR, respectively, of any technology or source code on the Commerce Control List (CCL) to a Syrian foreign national. Deemed exports and deemed reexports to Syrian foreign nationals involving technology or source code subject to the EAR but not listed on the CCL do not require a license. * * * * * PART 774--[AMENDED] 0 11. The authority citation for 15 CFR part 774 continues to read as follows: Authority: 50 U.S.C. 4601 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; 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 15, 2017, 82 FR 39005 (August 16, 2017). 0 12. In supplement No. 1 to part 774, Category 0, ECCN 0A606 is revised to read as follows: Supplement No. 1 to Part 774--The Commerce Control List * * * * * 0A606 Ground vehicles and related commodities, as follows (see List of Items Controlled). License Requirements Reason for Control: NS, RS, AT, UN Country Chart (See Supp. No. Control(s) 1 to part 738) NS applies to entire entry, except 0A606.b NS Column 1 and .y. NS applies to 0A606.b..................... NS Column 2 RS applies to entire entry, except 0A606.b RS Column 1 and .y. RS applies to 0A606.b..................... RS Column 2 AT applies to entire entry................ AT Column 1 UN applies to entire entry, except 0A606.y See Sec. 746.1(b) for UN controls List Based License Exceptions (See Part 740 for a description of all license exceptions) LVS: $1500 GBS: N/A CIV: N/A Special Conditions for STA STA: (1) Paragraph (c)(1) of License Exception STA (Sec. 740.20(c)(1) of the EAR) may not be used for any item in 0A606.a, unless determined by BIS to be eligible for License Exception STA in accordance with Sec. 740.20(g) (License Exception STA eligibility requests for 9x515 and ``600 series'' items). (2) Paragraph (c)(2) of License Exception STA (Sec. 740.20(c)(2) of the EAR) may not be used for any item in 0A606. List of Items Controlled Related Controls: (1) The ground vehicles, other articles, technical data (including software) and services described in 22 CFR part 121, Category VII are subject to the jurisdiction of the International Traffic in Arms Regulations. (2) See ECCN 0A919 for foreign-made ``military commodities'' that incorporate more than a de minimis amount of U.S.-origin ``600 series'' controlled content. Related Definitions: N/A Items: a. Ground vehicles, whether manned or unmanned, ``specially designed'' for a military use and not enumerated or otherwise described in USML Category VII. Note 1 to paragraph .a: For purposes of paragraph .a, ``ground vehicles'' include (i) tanks and armored vehicles manufactured prior to 1956 that have not been modified since 1955 and that do not contain a functional weapon or a weapon capable of becoming functional through repair; (ii) military railway trains except those that are armed or are ``specially designed'' to launch missiles; (iii) unarmored military recovery and other support vehicles; (iv) unarmored, unarmed vehicles with mounts or hard points for firearms of .50 caliber or less; and (v) trailers ``specially designed'' for use with other ground vehicles enumerated in USML Category VII or ECCN 0A606.a, and not [[Page 61158]] separately enumerated or otherwise described in USML Category VII. For purposes of this note, the term ``modified'' does not include incorporation of safety features required by law, cosmetic changes (e.g., different paint or repositioning of bolt holes) or addition of ``parts'' or ``components'' available prior to 1956. Note 2 to paragraph .a: A ground vehicle's being ``specially designed'' for military use for purposes of determining controls under paragraph .a. entails a structural, electrical or mechanical feature involving one or more ``components'' that are ``specially designed'' for military use. Such ``components'' include: a. Pneumatic tire casings of a kind ``specially designed'' to be bullet-proof; b. Armored protection of vital ``parts'' (e.g., fuel tanks or vehicle cabs); c. Special reinforcements or mountings for weapons; d. Black-out lighting. b. Other ground vehicles, ``parts'' and ``components,'' as follows: b.1. Unarmed vehicles that are derived from civilian vehicles and that have all of the following: b.1.a. Manufactured or fitted with materials or ``components'' other than reactive or electromagnetic armor to provide ballistic protection to level III (National Institute of Justice standard 0108.01, September 1985) or better; b.1.b. A transmission to provide drive to both front and rear wheels simultaneously, including those vehicles having additional wheels for load bearing purposes whether driven or not; b.1.c. Gross vehicle weight rating (GVWR) greater than 4,500 kg; and b.1.d. Designed or modified for off-road use. b.2. ``Parts'' and ``components'' having all of the following: b.2.a. ``Specially designed'' for vehicles specified in paragraph .b.1 of this entry; and b.2.b. Providing ballistic protection to level III (National Institute of Justice standard 0108.01, September 1985) or better. Note 1 to paragraph b: Ground vehicles otherwise controlled by 0A606.b.1 that contain reactive or electromagnetic armor are subject to the controls of USML Category VII. Note 2 to paragraph b: ECCN 0A606.b.1 does not control civilian vehicles ``specially designed'' for transporting money or valuables. Note 3 to paragraph b: ``Unarmed'' means not having installed weapons, installed mountings for weapons, or special reinforcements for mounts for weapons. c. Air-cooled diesel engines and engine blocks for armored vehicles that weigh more than 40 tons. d. Fully automatic continuously variable transmissions for tracked combat vehicles. e. Deep water fording kits ``specially designed'' for ground vehicles controlled by ECCN 0A606.a or USML Category VII. f. Self-launching bridge ``components'' not enumerated in USML Category VII(g) ``specially designed'' for deployment by ground vehicles enumerated in USML Category VII or this ECCN. g. through w. [RESERVED] x. ``Parts,'' ``components,'' ``accessories,'' and ``attachments'' that are ``specially designed'' for a commodity enumerated or otherwise described in ECCN 0A606 (other than 0A606.b or 0A606.y) or a defense article enumerated in USML Category VII and not elsewhere specified on the USML or in 0A606.y. Note 1: Forgings, castings, and other unfinished products, such as extrusions and machined bodies, that have reached a stage in manufacture where they are clearly identifiable by mechanical properties, material composition, geometry, or function as commodities controlled by ECCN 0A606.x are controlled by ECCN 0A606.x. Note 2: ``Parts,'' ``components,'' ``accessories'' and ``attachments'' enumerated in USML paragraph VII(g) are subject to the controls of that paragraph. ``Parts,'' ``components,'' ``accessories'' and ``attachments'' described in ECCN 0A606.y are subject to the controls of that paragraph. y. Specific ``parts,'' ``components,'' ``accessories,'' and ``attachments'' ``specially designed'' for a commodity enumerated or otherwise described in this ECCN (other than ECCN 0A606.b) or for a defense article in USML Category VII and not elsewhere specified on the USML or the CCL, as follows, and ``parts,'' ``components,'' ``accessories,'' and ``attachments'' ``specially designed'' therefor: y.1. Brake discs, rotors, drums, calipers, cylinders, pads, shoes, lines, hoses, vacuum boosters, and parts therefor; y.2. Alternators and generators; y.3. Axles; y.4. Batteries; y.5. Bearings (e.g., ball, roller, wheel); y.6. Cables, cable assembles, and connectors; y.7. Cooling system hoses; y.8. Hydraulic, fuel, oil, and air filters, other than those controlled by ECCN 1A004; y.9. Gaskets and o-rings; y.10. Hydraulic system hoses, fittings, couplings, adapters, and valves; y.11. Latches and hinges; y.12. Lighting systems, fuses, and ``components;'' y.13. Pneumatic hoses, fittings, adapters, couplings, and valves; y.14. Seats, seat assemblies, seat supports, and harnesses; y.15. Tires, except run flat; and y.16. Windows, except those for armored vehicles. 0 13. In supplement No. 1 to part 774, Category 0, ECCN 0D606 is revised to read as follows: 0D606 ``Software'' ``specially designed'' for the ``development,'' ``production,'' operation, or maintenance of ground vehicles and related commodities controlled by 0A606, 0B606, or 0C606 (see List of Items Controlled). License Requirements Reason for Control: NS, RS, AT, UN Country Chart (See Supp. No. Control(s) 1 to part 738) NS applies to entire entry................ NS Column 1 RS applies to entire entry................ RS Column 1 AT applies to entire entry................ AT Column 1 UN applies to entire entry................ See Sec. 746.1(b) for UN controls List Based License Exceptions (See Part 740 for a description of all license exceptions) CIV: N/A TSR: N/A Special Conditions for STA STA: Paragraph (c)(2) of License Exception STA (Sec. 740.20(c)(2) of the EAR) may not be used for any ``software'' in 0D614. List of Items Controlled Related Controls: (1) ``Software'' directly related to articles enumerated in USML Category IX is subject to the control of USML paragraph IX(e). (2) See ECCN 0A919 for foreign made ``military commodities'' that incorporate more than a de minimis amount of US- origin ``600 series'' items. Related Definitions: N/A Items: a. ``Software'' ``specially designed'' for the ``development,'' ``production,'' operation, or maintenance of commodities controlled by ECCNs 0A606 (except for ECCNs 0A606.b or 0A606.y), 0B606, or 0C606. b. [RESERVED] 0 14. In supplement No. 1 to part 774, Category 0, ECCN 0E606 is revised to read as follows: 0E606 ``Technology'' ``required'' for the ``development,'' ``production,'' operation, installation, maintenance, repair, overhaul, or refurbishing of ground vehicles and related commodities in 0A606, 0B606, 0C606, or software in 0D606 (see List of Items Controlled). License Requirements Reason for Control: NS, RS, AT, UN Country Chart (See Supp. No. Control(s) 1 to part 738) NS applies to entire entry................ NS Column 1 RS applies to entire entry................ RS Column 1 AT applies to entire entry................ AT Column 1 UN applies to entire entry................ See Sec. 746.1(b) for UN controls List Based License Exceptions (See Part 740 for a description of all license exceptions) CIV: N/A TSR: N/A Special Conditions for STA STA: Paragraph (c)(2) of License Exception STA (Sec. 740.20(c)(2) of the EAR) may not be used for any technology in 0E614. [[Page 61159]] List of Items Controlled Related Controls: ``Technical data'' directly related to articles enumerated in USML Category IX is subject to the control of USML paragraph IX(e). Related Definitions: N/A Items: a. ``Technology'' ``required'' for the ``development,'' ``production,'' operation, installation, maintenance, repair, overhaul, or refurbishing of commodities enumerated or otherwise described in ECCN 0A606 (except for ECCNs 0A606.b or 0A606.y), 0B606, or 0C606. b. [RESERVED] 0 15. In supplement No. 1 to part 774, Category 2, ECCN 2B352 is revised to read as follows: 2B352 Equipment capable of use in handling biological materials, as follows (see List of Items Controlled). License Requirements Reason for Control: CB, AT Country Chart (See Supp. No. Control(s) 1 to part 738). CB applies to entire entry................ CB Column 2 AT applies to entire entry................ AT Column 1 List Based License Exceptions (See Part 740 for a description of all license exceptions) LVS: N/A GBS: N/A CIV: N/A List of Items Controlled Related Controls: See ECCNs 1A004 and 1A995 for protective equipment that is not covered by this entry. Also see ECCN 9A120 for controls on certain ``UAV'' systems designed or modified to dispense an aerosol and capable of carrying elements of a payload in the form of a particulate or liquid, other than fuel ``parts'' or ``components'' of such vehicles, of a volume greater than 20 liters. Related Definitions: (1) ``Lighter than air vehicles''--balloons and airships that rely on hot air or on lighter-than-air gases, such as helium or hydrogen, for their lift. (2) ``UAVs''--Unmanned Aerial Vehicles. (3) ``VMD''--Volume Median Diameter. Items: a. Containment facilities and related equipment, as follows: a.1. Complete containment facilities at P3 or P4 containment level. Technical Note: P3 or P4 (BL3, BL4, L3, L4) containment levels are as specified in the WHO Laboratory Biosafety Manual (3rd edition, Geneva, 2004). a.2. Equipment designed for fixed installation in containment facilities specified in paragraph a.1 of this ECCN, as follows: a.2.a. Double-door pass-through decontamination autoclaves; a.2.b. Breathing air suit decontamination showers; a.2.c. Mechanical-seal or inflatable-seal walkthrough doors. b. Fermenters and components as follows: b.1. Fermenters capable of cultivation of micro-organisms or of live cells for the production of viruses or toxins, without the propagation of aerosols, having a capacity of 20 liters or greater. b.2. Components designed for such fermenters, as follows: b.2.a. Cultivation chambers designed to be sterilized or disinfected in situ; b.2.b. Cultivation chamber holding devices; or b.2.c. Process control units capable of simultaneously monitoring and controlling two or more fermentation system parameters (e.g., temperature, pH, nutrients, agitation, dissolved oxygen, air flow, foam control). Technical Note: Fermenters include bioreactors (including single-use (disposable) bioreactors), chemostats and continuous-flow systems. c. Centrifugal separators capable of the continuous separation of pathogenic microorganisms, without the propagation of aerosols, and having all of the following characteristics: c.1. One or more sealing joints within the steam containment area; c.2. A flow rate greater than 100 liters per hour; c.3. ``Parts'' or ``components'' of polished stainless steel or titanium; and c.4. Capable of in-situ steam sterilization in a closed state. Technical Note: Centrifugal separators include decanters. d. Cross (tangential) flow filtration equipment and ``accessories,'' as follows: d.1. Cross (tangential) flow filtration equipment capable of separation of microorganisms, viruses, toxins or cell cultures having all of the following characteristics: d.1.a. A total filtration area equal to or greater than 1 square meter (1 m2); and d.1.b. Having any of the following characteristics: d.1.b.1. Capable of being sterilized or disinfected in-situ; or d.1.b.2. Using disposable or single-use filtration ``parts'' or ``components''. N.B.: 2B352.d.1 does not control reverse osmosis and hemodialysis equipment, as specified by the manufacturer. d.2. Cross (tangential) flow filtration ``parts'' or ``components'' (e.g., modules, elements, cassettes, cartridges, units or plates) with filtration area equal to or greater than 0.2 square meters (0.2 m2) for each component and designed for use in cross (tangential) flow filtration equipment controlled by 2B352.d.1. TECHNICAL NOTE: In this ECCN, ``sterilized'' denotes the elimination of all viable microbes from the equipment through the use of either physical (e.g., steam) or chemical agents. ``Disinfected'' denotes the destruction of potential microbial infectivity in the equipment through the use of chemical agents with a germicidal effect. ``Disinfection'' and ``sterilization'' are distinct from ``sanitization'', the latter referring to cleaning procedures designed to lower the microbial content of equipment without necessarily achieving elimination of all microbial infectivity or viability. e. Steam, gas or vapor sterilizable freeze-drying equipment with a condenser capacity of 10 kg of ice or greater in 24 hours (10 liters of water or greater in 24 hours) and less than 1000 kg of ice in 24 hours (less than 1,000 liters of water in 24 hours). f. Spray-drying equipment capable of drying toxins or pathogenic microorganisms having all of the following characteristics: f.1. A water evaporation capacity of >= 0.4 kg/h and <= 400 kg/ h; f.2. The ability to generate a typical mean product particle size of <= 10 micrometers with existing fittings or by minimal modification of the spray-dryer with atomization nozzles enabling generation of the required particle size; and f.3. Capable of being sterilized or disinfected in situ. g. Protective and containment equipment, as follows: g.1. Protective full or half suits, or hoods dependent upon a tethered external air supply and operating under positive pressure; Technical Note: This entry does not control suits designed to be worn with self-contained breathing apparatus. g.2. Biocontainment chambers, isolators, or biological safety cabinets having all of the following characteristics, for normal operation: g.2.a. Fully enclosed workspace where the operator is separated from the work by a physical barrier; g.2.b. Able to operate at negative pressure; g.2.c. Means to safely manipulate items in the workspace; and g.2.d. Supply and exhaust air to and from the workspace is high- efficiency particulate air (HEPA) filtered. Note 1 to 2B352.g.2: 2B352.g.2 controls class III biosafety cabinets, as specified in the WHO Laboratory Biosafety Manual (3rd edition, Geneva, 2004) or constructed in accordance with national standards, regulations or guidance. Note 2 to 2B352.g.2: 2B352.g.2 does not control isolators ``specially designed'' for barrier nursing or transportation of infected patients. h. Aerosol inhalation equipment designed for aerosol challenge testing with microorganisms, viruses or toxins, as follows: h.1. Whole-body exposure chambers having a capacity of 1 cubic meter or greater. h.2. Nose-only exposure apparatus utilizing directed aerosol flow and having a capacity for the exposure of 12 or more rodents, or two or more animals other than rodents, and closed animal restraint tubes designed for use with such apparatus. i. Spraying or fogging systems and ``parts'' and ``components'' therefor, as follows: i.1. Complete spraying or fogging systems, ``specially designed'' or modified for fitting to ``aircraft,'' ``lighter than air vehicles,'' or ``UAVs,'' capable of delivering, from a liquid suspension, an initial droplet `VMD' of less than 50 microns at a flow rate of greater than 2 liters per minute; i.2. Spray booms or arrays of `aerosol generating units', ``specially designed'' or [[Page 61160]] modified for fitting to ``aircraft,'' ``lighter than air vehicles,'' or ``UAVs,'' capable of delivering, from a liquid suspension, an initial droplet `VMD' of less than 50 microns at a flow rate of greater than 2 liters per minute; i.3. `Aerosol generating units' ``specially designed'' for fitting to the systems specified in paragraphs i.1 or i.2 of this ECCN. Technical Notes: 1. `Aerosol generating units' are devices ``specially designed'' or modified for fitting to ``aircraft'' and include nozzles, rotary drum atomizers and similar devices. 2. This ECCN does not control spraying or fogging systems, ``parts'' and ``components,'' as specified in 2B352.i, that are demonstrated not to be capable of delivering biological agents in the form of infectious aerosols. 3. Volume Median Diameter `VMD' for droplets produced by spray equipment or nozzles ``specially designed'' for use on ``aircraft'' or ``UAVs'' should be measured using either of the following methods (pending the adoption of internationally accepted standards): a. Doppler ``laser'' method, b. Forward ``laser'' diffraction method. 0 16. In supplement No. 1 to part 774, Category 8, ECCN 8A609 is revised to read as follows: 8A609 Surface vessels of war and related commodities (see List of Items Controlled) License Requirements Reason for Control: NS, RS, AT, UN Country Chart (See Supp. No. Control(s) 1 to part 738) NS applies to entire entry, except 8A609.y NS Column 1 RS applies to entire entry, except 8A609.y RS Column 1 AT applies to entire entry................ AT Column 1 UN applies to entire entry, except 8A609.y See Sec. 746.1(b) for UN controls List Based License Exceptions (See Part 740 for a description of all license exceptions) LVS: $1500 GBS: N/A CIV: N/A Special Conditions for STA STA: (1) Paragraph (c)(1) of License Exception STA (Sec. 740.20(c)(1) of the EAR) may not be used for any item in 8A609.a, unless determined by BIS to be eligible for License Exception STA in accordance with Sec. 740.20(g) (License Exception STA eligibility requests for 9x515 and ``600 series'' items). List of Items Controlled Related Controls: (1) Surface vessels of war and special naval equipment, and technical data (including software), and services directly related thereto, described in 22 CFR part 121, Category VI, Surface Vessels of War and Special Naval Equipment, are subject to the jurisdiction of the International Traffic in Arms Regulations. (2) See ECCN 0A919 for foreign-made ``military commodities'' that incorporate more than a de minimis amount of U.S.-origin ``600 series'' controlled content. (3) For controls on diesel engines and electric motors that are ``subject to the EAR'' for surface vessels of war ``subject to the EAR'' or ``subject to the ITAR,'' see ECCN 8A992.g. For diesel engines and electric motors for surface vessels of war ``subject to the ITAR,'' see 22 CFR part 121, Category VI(c) for parts, components, accessories, and attachments, ``specially designed'' for developmental vessels funded by the Department of Defense via contract or other funding authorization. (4) For controls on military gas turbine engines and related items for vessels of war, see ECCN 9A619. Related Definitions: N/A Items: a. Surface vessels of war ``specially designed'' for a military use and not enumerated or otherwise described in the USML. Note 1: 8A609.a includes: (i) Underway replenishment ships; (ii) surface vessel and submarine tender and repair ships, except vessels that are ``specially designed'' to support naval nuclear propulsion plants; (iii) non-submersible submarine rescue ships; (iv) other auxiliaries (e.g., AGDS, AGF, AGM, AGOR, AGOS, AH, AP, ARL, AVB, AVM, and AVT); (v) amphibious warfare craft, except those that are armed; and (vi) unarmored and unarmed coastal, patrol, roadstead, and Coast Guard and other patrol craft with mounts or hard points for firearms of .50 caliber or less. Note 2: For purposes of paragraph .a, surface vessels of war includes vessels ``specially designed'' for military use that are not identified in paragraph (a) of ITAR Sec. 121.15, including any demilitarized vessels, regardless of origin or designation, manufactured prior to 1950 and that have not been modified since 1949. For purposes of this note, the term modified does not include incorporation of safety features required by law, cosmetic changes (e.g., different paint), or the addition of ``parts'' or ``components'' available prior to 1950. b. Non-magnetic diesel engines with a power output of 50 hp or more and either of the following: b.1. Non-magnetic content exceeding 25% of total weight; or b.2. Non-magnetic parts other than crankcase, block, head, pistons, covers, end plates, valve facings, gaskets, and fuel, lubrication and other supply lines. c. through w. [RESERVED] x. ``Parts,'' ``components,'' ``accessories'' and ``attachments'' that are ``specially designed'' for a commodity enumerated or otherwise described in ECCN 8A609 (except for 8A609.y) or a defense article enumerated or otherwise described in USML Category VI and not specified elsewhere on the USML, in 8A609.y or 3A611.y. Note 1: Forgings, castings, and other unfinished products, such as extrusions and machined bodies, that have reached a stage in manufacturing where they are clearly identifiable by mechanical properties, material composition, geometry, or function as commodities controlled by ECCN 8A609.x are controlled by ECCN 8A609.x. Note 2: ``Parts,'' ``components,'' ``accessories'' and ``attachments'' specified in USML subcategory VI(f) are subject to the controls of that paragraph. ``Parts,'' ``components,'' ``accessories,'' and ``attachments'' specified in ECCN 8A609.y are subject to the controls of that paragraph. y. Specific ``parts,'' ``components,'' ``accessories'' and ``attachments'' ``specially designed'' for a commodity subject to control in this ECCN or for a defense article in USML Category VI and not elsewhere specified in the USML, as follows, and ``parts,'' ``components,'' ``accessories,'' and ``attachments'' ``specially designed'' therefor: y.1. Public address (PA) systems; y.2. Filters and filter assemblies, hoses, lines, fittings, couplings, and brackets for pneumatic, hydraulic, oil and fuel systems; y.3. Galleys; y.4. Lavatories; y.5. Magnetic compass, magnetic azimuth detector; y.6. Medical facilities; y.7. Potable water tanks, filters, valves, hoses, lines, fittings, couplings, and brackets; y.8. Panel knobs, indicators, switches, buttons, and dials whether unfiltered or filtered for use with night vision imaging systems; y.9. Emergency lighting; y.10. Gauges and indicators; y.11. Audio selector panels. 0 17. In supplement No. 1 to part 774, Category 9, ECCN 9A610 is revised to read as follows. 9A610 Military aircraft and related commodities, other than those enumerated in 9A991.a (see List of Items Controlled) License Requirements Reason for Control: NS, RS, MT, AT, UN Country Chart (See Supp. No. Control(s) 1 to part 738) NS applies to entire entry except: NS Column 1 9A610.b; parts and components controlled in 9A610.x if being exported or reexported for use in an aircraft controlled in 9A610.b; and 9A610.y. RS applies to entire entry except: RS Column 1 9A610.b; parts and components controlled in 9A610.x if being exported or reexported for use in an aircraft controlled in 9A610.b; and 9A610.y. [[Page 61161]] MT applies to 9A610.t, .u, .v, and .w..... MT Column 1 AT applies to entire entry................ AT Column 1 UN applies to entire entry except 9A610.y. See Sec. 746.1(b) for UN controls List Based License Exceptions (See Part 740 for a description of all license exceptions) LVS: $1500 GBS: N/A CIV: N/A Special Conditions For STA STA: (1) Paragraph (c)(1) of License Exception STA (Sec. 740.20(c)(1) of the EAR) may not be used for any item in 9A610.a (i.e., ``end item'' military aircraft), unless determined by BIS to be eligible for License Exception STA in accordance with Sec. 740.20(g) (License Exception STA eligibility requests for 9x515 and ``600 series'' items). (2) Paragraph (c)(2) of License Exception STA (Sec. 740.20(c)(2) of the EAR) may not be used for any item in 9A610. List of Items Controlled Related Controls: (1) Military aircraft and related articles that are enumerated in USML Category VIII, and technical data (including software) directly related thereto, are subject to the ITAR. (2) See ECCN 0A919 for controls on foreign-made ``military commodities'' that incorporate more than a de minimis amount of U.S.-origin ``600 series'' controlled content. (3) See USML Category XIX and ECCN 9A619 for controls on military aircraft gas turbine engines and related items. Related Definitions: In paragraph .y of this entry, the term `fluid' includes liquids and gases. Items: a. `Military Aircraft' ``specially designed'' for a military use that are not enumerated in USML paragraph VIII(a). Note 1: For purposes of paragraph .a the term `military aircraft' means the LM-100J aircraft and any aircraft ``specially designed'' for a military use that are not enumerated in USML paragraph VIII(a). The term includes: Trainer aircraft; cargo aircraft; utility fixed wing aircraft; military helicopters; observation aircraft; military non-expansive balloons and other lighter than air aircraft; and unarmed military aircraft, regardless of origin or designation. Aircraft with modifications made to incorporate safety of flight features or other FAA or NTSB modifications such as transponders and air data recorders are ``unmodified'' for the purposes of this paragraph .a. Note 2: 9A610.a does not control `military aircraft' that: a. Were first manufactured before 1946; b. Do not incorporate defense articles enumerated or otherwise described on the U.S. Munitions List, unless the items are required to meet safety or airworthiness standards of a Wassenaar Arrangement Participating State; and c. Do not incorporate weapons enumerated or otherwise described on the U.S. Munitions List, unless inoperable and incapable of being returned to operation. b. L-100 aircraft manufactured prior to 2013. c.-d. [Reserved] e. Mobile aircraft arresting and engagement runway systems for aircraft controlled by either USML Category VIII(a) or ECCN 9A610.a. f. Pressure refueling equipment and equipment that facilitates operations in confined areas, ``specially designed'' for aircraft controlled by either USML paragraph VIII(a) or ECCN 9A610.a. g. Aircrew life support equipment, aircrew safety equipment and other devices for emergency escape from aircraft controlled by either USML paragraph VIII(a) or ECCN 9A610.a. h. Parachutes, paragliders, complete parachute canopies, harnesses, platforms, electronic release mechanisms, ``specially designed'' for use with aircraft controlled by either USML paragraph VIII(a) or ECCN 9A610.a, and ``equipment'' ``specially designed'' for military high altitude parachutists, such as suits, special helmets, breathing systems, and navigation equipment. i. Controlled opening equipment or automatic piloting systems, designed for parachuted loads. j. Ground effect machines (GEMS), including surface effect machines and air cushion vehicles, ``specially designed'' for use by a military. k. through s. [Reserved] t. Composite structures, laminates, and manufactures thereof ``specially designed'' for unmanned aerial vehicles controlled under USML Category VIII(a) with a range equal to or greater than 300 km. Note to paragraph .t: Composite structures, laminates, and manufactures thereof ``specially designed'' for unmanned aerial vehicles controlled under USML Category VIII(a) with a maximum range less than 300 km are controlled in paragraph .x of this entry. u. Apparatus and devices ``specially designed'' for the handling, control, activation and non-ship-based launching of UAVs or drones controlled by either USML paragraph VIII(a) or ECCN 9A610.a, and capable of a range equal to or greater than 300 km. Note to paragraph .u: Apparatus and devices ``specially designed'' for the handling, control, activation and non-ship-based launching of UAVs or drones controlled by either USML paragraph VIII(a) or ECCN 9A610.a with a maximum range less than 300 km are controlled in paragraph .x of this entry. v. Radar altimeters designed or modified for use in UAVs or drones controlled by either USML paragraph VIII(a) or ECCN 9A610.a., and capable of delivering at least 500 kilograms payload to a range of at least 300 km. Note to paragraph .v: Radar altimeters designed or modified for use in UAVs or drones controlled by either USML paragraph VIII(a) or ECCN 9A610.a. that are not capable of delivering at least 500 kilograms payload to a range of at least 300 km are controlled in paragraph .x of this entry. w. Pneumatic hydraulic, mechanical, electro-optical, or electromechanical flight control systems (including fly-by-wire and fly-by-light systems) and attitude control equipment designed or modified for UAVs or drones controlled by either USML paragraph VIII(a) or ECCN 9A610.a., and capable of delivering at least 500 kilograms payload to a range of at least 300 km. Note to paragraph .w: Pneumatic, hydraulic, mechanical, electro-optical, or electromechanical flight control systems (including fly-by-wire and fly-by-light systems) and attitude control equipment designed or modified for UAVs or drones controlled by either USML paragraph VIII(a) or ECCN 9A610.a., not capable of delivering at least 500 kilograms payload to a range of at least 300 km are controlled in paragraph .x of this entry. x. ``Parts,'' ``components,'' ``accessories,'' and ``attachments'' that are ``specially designed'' for a commodity enumerated or otherwise described in ECCN 9A610 (except for 9A610.y) or a defense article enumerated or otherwise described in USML Category VIII and not elsewhere specified on the USML or in 9A610.y, 9A619.y, or 3A611.y. y. Specific ``parts,'' ``components,'' ``accessories,'' and ``attachments'' ``specially designed'' for a commodity subject to control in this entry, ECCN 9A619, or for a defense article in USML Categories VIII or XIX and not elsewhere specified in the USML or the CCL, and other aircraft commodities ``specially designed'' for a military use, as follows, and ``parts,'' ``components,'' ``accessories,'' and ``attachments'' ``specially designed'' therefor: y.1. Aircraft tires; y.2. Analog gauges and indicators; y.3. Audio selector panels; y.4. Check valves for hydraulic and pneumatic systems; y.5. Crew rest equipment; y.6. Ejection seat mounted survival aids; y.7. Energy dissipating pads for cargo (for pads made from paper or cardboard); y.8. Fluid filters and filter assemblies; y.9. Galleys; y.10. Fluid hoses, straight and unbent lines (for a commodity subject to control in this entry or defense article in USML Category VIII), and fittings, couplings, clamps (for a commodity subject to control in this entry or defense article in USML Category VIII) and brackets therefor; y.11. Lavatories; y.12. Life rafts; y.13. Magnetic compass, magnetic azimuth detector; y.14. Medical litter provisions; y.15. Cockpit or cabin mirrors; y.16. Passenger seats including palletized seats; y.17. Potable water storage systems; y.18. Public address (PA) systems; y.19. Steel brake wear pads (does not include sintered mix or carbon/carbon materials); y.20. Underwater locator beacons; [[Page 61162]] y.21. Urine collection bags/pads/cups/pumps; y.22. Windshield washer and wiper systems; y.23. Filtered and unfiltered panel knobs, indicators, switches, buttons, and dials; y.24. Lead-acid and Nickel-Cadmium batteries; y.25. Propellers, propeller systems, and propeller blades used with reciprocating engines; y.26. Fire extinguishers; y.27. Flame and smoke/CO2 detectors; y.28. Map cases; y.29. `Military Aircraft' that were first manufactured from 1946 to 1955 that do not incorporate defense articles enumerated or otherwise described on the U.S. Munitions List, unless the items are required to meet safety or airworthiness standards of a Wassenaar Arrangement Participating State; and do not incorporate weapons enumerated or otherwise described on the U.S. Munitions List, unless inoperable and incapable of being returned to operation; y.30. ``Parts,'' ``components,'' ``accessories,'' and ``attachments,'' other than electronic items or navigation equipment, for use in or with a commodity controlled by ECCN 9A610.h; y.31. Identification plates and nameplates; and y.32. Fluid manifolds. Dated: December 18, 2017. Richard E. Ashooh, Assistant Secretary for Export Administration. [FR Doc. 2017-27616 Filed 12-26-17; 8:45 am] BILLING CODE 3510-33-P
![Federal Register / Vol. 82, No. 247 / Wednesday, December 27, 2017 / Rules and Regulations 61153
(ii) Reserved. Overview for clarity. Finally, this final rule
(3) For RRC service information identified changes the supplement’s name from
in this AD, contact Rolls-Royce Corporation, This final rule updates six parts of the
EAR to correct typographical errors, ‘‘Decision Tree’’ to ‘‘Export Control
450 South Meridian Street, Mail Code NB– Decision Tree’’ to match the title of the
02–05, Indianapolis, IN 46225; phone: 317– clarify inaccurate or unclear internal
230–3774; email: indy.pubs.services@rolls- references, and correct inconsistencies diagram, and the duplicative
royce.com; internet: www.rolls-royce.com. in certain entries on the Commerce parenthetical in the graphic title reading
(4) You may view this service information Control List (CCL). ‘‘(Supp. No. 1 to Part 732)’’ is deleted.
at FAA, Engine and Propeller Standards Part 734
Branch, 1200 District Avenue, Burlington, Part 732
MA 01803. For information on the Section 734.18 was created in the rule
Section 732.4(b) discusses steps to be
availability of this material at the FAA, call Revisions to Definitions in the Export
taken when reviewing license
781–238–7125. Administration Regulations (81 FR
(5) You may view this service information exceptions for exports and reexports. In
35586 (June 3, 2016)) and discusses
that is incorporated by reference at the § 732.4(b)(7)(ii), there is a reference to
activities that are not exports, reexports,
National Archives and Records § 740.20(g) listing ECCNs that may be
or transfers. The note following the end
Administration (NARA). For information on eligible for subsequent export or of § 734.18(a)(5)(iv) discusses data in
the availability of this material at NARA, call reexport under license exception STA, transit via the internet, but the note is
202–741–6030, or go to: http:// following submission of a license
www.archives.gov/federal-register/cfr/ibr- incorrectly described as the note to
application. However, only ECCN paragraph (a)(4)(iv). This rule changes
locations.html. 9A610.a is listed in § 732.4(b)(7)(ii), the note to refer to § 734.18(a)(5)(iv).
Issued in Burlington, Massachusetts, on while ECCNs 0A606.a, 8A609.a,
December 18, 2017. 8A620.a, 8A620.b, ‘‘spacecraft’’ in ECCN Part 738
Robert J. Ganley, subparagraphs 9A515.a.1, a.2, a.3, a.4, In § 738.2(d)(1), Composition of an
Manager, Engine and Propeller Standards 9A515.g, and 9E515.b, .d, .e, and .f entry, there is a description of the
Branch, Aircraft Certification Service. (which also now appear in § 740.20(g)), meaning attached to each alphanumeric
[FR Doc. 2017–27778 Filed 12–26–17; 8:45 am] are inadvertently omitted. This character making up an Export Control
BILLING CODE 4910–13–P correction adds the omitted items listed Classification Number. This paragraph
in § 740.20(g) to § 732.4(b)(7)(ii). currently explains that the second
Additionally, because these items ‘‘digit’’ in an ECCN indicates the
include both commodities and ‘‘Reason for Control.’’ However, in
DEPARTMENT OF COMMERCE technology, the term ‘‘aircraft’’ in the paragraph (d)(1)(i) of this section, the
Bureau of Industry and Security reference to 9A610.a is replaced with paragraph refers to the Reason for
‘‘item.’’ Control as the third ‘‘digit.’’ This final
15 CFR Parts 732, 734, 738, 740, 746, This rule also clarifies and corrects rule amends § 738.2(d)(1)(i) to replace
and 774 the Export Control Decision Tree the word ‘‘digit’’ with ‘‘alphanumeric
diagram in supplement No. 1 to part 732 character’’ in order to maintain
[170207157–7157–01] that was last revised in a final rule consistency and prevent confusion.
published February 6, 2004 (69 FR 5686 Additionally, in § 738.2, this final rule
RIN 0694–AH31 (Feb. 6, 2004)). Several of the decision makes a correction in
‘‘blocks’’ in the flowchart contain § 738.2(d)(2)(iv)(C)(2). The text of this
Revisions, Clarifications, and references that are unclear or incorrect. paragraph uses ECCN 2B992 as an
Technical Corrections to the Export This rule provides clarity by changing example when providing an overview of
Administration Regulations references to the general prohibitions to how to read an ECCN heading on the
AGENCY: Bureau of Industry and citations of specific sections of the EAR, Commerce Control List (CCL). However,
Security, Commerce. and correcting improper citations to in the latter part of the section, the text
ensure that the citations contained in all erroneously references ECCN 2B999
ACTION: Final rule; correcting
decision blocks coincide with the instead of 2B992. This rule replaces the
amendments.
appropriate sections of the EAR. reference to ECCN 2B999 with 2B992 in
SUMMARY: In this final rule, the Bureau Specifically, the changes are as follows: this section to correct the ECCN
of Industry and Security corrects certain In the block which begins ‘‘Is your item reference.
provisions in the Export Administration classified under an ECCN on the CCL,’’
a direct citation to § 736.2(b)(1) through Part 740
Regulations (EAR) to provide accurate
references and fix typographical errors, (3) replaces a reference to General Section 740.20(g)(1) lists 9x515 and
and amend several Export Control Prohibitions 1 through 3, which did not ‘‘600 series’’ ECCNs that are eligible for
Classification Numbers (ECCNs) to inform the reader where the license exception Strategic Trade
enhance consistency with the other prohibitions could be found in the EAR; Authorization. This includes ECCNs
ECCNs on the Commerce Control List in the block which begins ‘‘Is there an 9A515.a.1, .a.2, .a.3, .a.4, and .g,
(CCL). The corrections are editorial in ‘X’ in the box,’’ the EAR citations now 9A610.a, and technology ECCNs
nature and do not affect license directly follow references to the 9E515.b, .d, .e, and .f. In the final rule
requirements. Commerce Country Chart and the CCL, Revisions to the Export Administration
respectively; and, in the block which Regulations (EAR): Control of
DATES: This rule is effective December begins ‘‘Use License Exception,’’ the Spacecraft Systems and Related Items
27, 2017. citation to § 740.1, which is an the President Determines No Longer
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FOR FURTHER INFORMATION CONTACT: Ivan introduction, is replaced with a Warrant Control under the United States
Mogensen, Office of Exporter Services, reference to the whole of part 740. Munitions List (USML) (82 FR 2875 (Jan.
Bureau of Industry and Security, by Additionally, several grammatical errors 10, 2017)), the phrase ‘‘that provide
telephone: (202) 482–2440 or email: are addressed, and the section symbol space-based logistics, assembly or
Ivan.Mogensen@bis.doc.gov. (‘‘§ ’’) is added wherever a section of the servicing of any spacecraft (e.g.,
SUPPLEMENTARY INFORMATION: EAR is referenced in the decision blocks refueling)’’ following the list of ECCN
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30-day delay in effectiveness otherwise 15 CFR Parts 746 and 774 9A515.a.1, a.2, a.3, a.4 or 9A515.g,
required by 5 U.S.C. 553(d) is not Exports, Reporting and recordkeeping ECCN 9A610.a, or technology under
applicable. No other law requires that a requirements. ECCNs 9E515.b, .d, .e, or .f, § 740.20(g)
notice of proposed rulemaking and Accordingly, parts 732, 734, 738, 740, permits you to request in the
opportunity for public comment be 746, and 774 of the Export application that subsequent exports of
given for this rule. The analytical Administration Regulations (15 CFR the type of aircraft, spacecraft, military
requirements of the Regulatory parts 730 through 774) are amended as vessels, or technology at issue be
Flexibility Act (5 U.S.C. 601 et seq.) are follows: eligible for export under License
not applicable because no general notice Exception STA. The types of ‘‘items’’
of proposed rulemaking was required PART 732—[AMENDED] controlled under ECCNs 0A606.a,
for this rule by 5 U.S.C. 553, or by any 8A609.a, 8A620.a, 8A620.b, certain
other law. Accordingly, no regulatory ■ 1. The authority citation for 15 CFR spacecraft controlled under ECCN
flexibility analysis is required and none part 732 continues to read as follows: subparagraphs 9A515.a.1, a.2, a.3, a.4 or
has been prepared. Authority: 50 U.S.C. 4601 et seq.; 50 9A515.g, ECCN 9A610.a, and
U.S.C. 1701 et seq.; E.O. 13026, 61 FR 58767, technology ECCNs 9E515.b, .d, .e, or .f,
List of Subjects
3 CFR, 1996 Comp., p. 228; E.O. 13222, 66 that have been determined to be eligible
15 CFR Part 732 FR 44025, 3 CFR, 2001 Comp., p. 783; Notice for License Exception STA pursuant to
of August 15, 2017, 82 FR 39005 (August 16, § 740.20(g) are identified in the License
Administrative practice and 2017). Exceptions paragraphs of ECCNs 0A606,
procedure, Exports, Reporting and
■ 2. Section 732.4 is amended by 8A609, 8A620, 9A610, 9A515, and
recordkeeping requirements
revising paragraph (b)(7)(ii) to read as 9E515. Supplement No. 2 to part 748,
15 CFR Part 734 follows: paragraph (w) (License Exception STA
eligibility requests), contains the
Administrative practice and § 732.4 Steps regarding License instructions for such applications.
procedure, Exports, Inventions and Exceptions.
patents, Research, Science and * * * * * Note 1 to paragraph (b)(7)(ii): If you intend
technology (b) * * * to use License Exception STA, return to
(7) * * * paragraphs (a) and then (b) of this section to
15 CFR Part 738 review the Steps regarding the use of license
(ii) If you are going to file a license
Exports application with BIS for the export, exceptions.
reexport, or in-country transfer for * * * * *
15 CFR Part 740
aircraft or military vessels controlled
Administrative practice and under ECCNs 0A606.a, 8A609.a, ■ 3. Supplement No. 1 to part 732 is
procedure, Exports, Reporting and 8A620.a, 8A620.b, certain ‘‘spacecraft’’ revised to read as follows:
recordkeeping requirements. controlled under ECCN subparagraphs BILLING CODE 3510–33–P
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example, if an item is controlled for or technology ECCNs 9E515.b, .d, .e, or 0A606 Ground vehicles and related
both National Security and Missile .f. commodities, as follows (see List of Items
Technology reasons, the entry’s third Controlled).
* * * * *
alphanumeric character will be a ‘‘0’’. If License Requirements
the item is controlled only for Missile PART 746—[AMENDED] Reason for Control: NS, RS, AT, UN
Technology the third alphanumeric
character will be ‘‘1’’. ■ 10. The authority citation for 15 CFR Country Chart (See
(2) * * * part 746 is revised to read as follows: Control(s) Supp. No. 1 to part
738)
(iv) * * * Authority: 50 U.S.C. 4601 et seq.; 50 U.S.C.
1701 et seq.; 22 U.S.C. 287c; Sec 1503, Pub. NS applies to entire NS Column 1
(C) * * *
L. 108–11, 117 Stat. 559; 22 U.S.C. 6004; 22 entry, except
(2) ‘‘(See List of Items Controlled)’’ is U.S.C. 7201 et seq.; 22 U.S.C. 7210; E.O. 0A606.b and .y.
in the middle of the ECCN heading. If 12854, 58 FR 36587, 3 CFR, 1993 Comp., p. NS applies to NS Column 2
the phrase ‘‘(see List of Items 614; E.O. 12918, 59 FR 28205, 3 CFR, 1994 0A606.b.
RS applies to entire RS Column 1
Controlled)’’ appears in the middle of Comp., p. 899; E.O. 13222, 66 FR 44025, 3 entry, except
the ECCN heading, then all portions of CFR, 2001 Comp., p. 783; E.O. 13338, 69 FR 0A606.b and .y.
the heading that follow the phrase ‘‘(see 26751, 3 CFR, 2004 Comp., p 168; RS applies to RS Column 2
List of Items Controlled)’’ will list items Presidential Determination 2003–23, 68 FR 0A606.b.
26459, 3 CFR, 2004 Comp., p. 320; AT applies to entire AT Column 1
controlled in addition to the list in the entry.
Presidential Determination 2007–7, 72 FR
‘‘items’’ paragraph. An example of such UN applies to entire See § 746.1(b) for UN
1899, 3 CFR, 2006 Comp., p. 325; Notice of entry, except controls
a heading is ECCN 2B992 Non- August 15, 2017, 82 FR 39005 (August 16, 0A606.y.
‘‘numerically controlled’’ machine tools 2017); Notice of May 9, 2017, 82 FR 21909
for generating optical quality surfaces, (May 10, 2017). List Based License Exceptions (See Part 740
(see List of Items Controlled) and for a description of all license exceptions)
■ 9. Section 746.9 is amended by
‘‘specially designed’’ ‘‘parts’’ and LVS: $1500
revising paragraph (a) to read as follows:
‘‘components’’ therefor. Under the GBS: N/A
ECCN 2B992 example, the ‘‘items’’ § 746.9 Syria. CIV: N/A
paragraph must be reviewed to * * * * * Special Conditions for STA
determine whether your item is STA: (1) Paragraph (c)(1) of License
contained within the first part of the (a) License requirements. A license is
required for the export or reexport to Exception STA (§ 740.20(c)(1) of the EAR)
heading (‘‘non-‘numerically controlled’ may not be used for any item in 0A606.a,
machine tools for generating optical Syria of all items subject to the EAR, unless determined by BIS to be eligible for
quality surfaces’’) and classified under except food and medicine classified as License Exception STA in accordance with
2B992. The second part of the ECCN EAR99 (food and medicine are defined § 740.20(g) (License Exception STA
2B992 heading (‘‘and ‘specially in part 772 of the EAR). A license is eligibility requests for 9x515 and ‘‘600
designed’ ‘parts’ and ‘components’ required for the deemed export and series’’ items). (2) Paragraph (c)(2) of
deemed reexport, as described in License Exception STA (§ 740.20(c)(2) of
therefor’’) contains the exclusive list the EAR) may not be used for any item in
described in the heading. ECCNs 1A006, §§ 734.13(b) and 734.14(b) of the EAR,
respectively, of any technology or 0A606.
3B992, 4A001, 6A006 and 7A001 are
other examples where the phrase ‘‘(see source code on the Commerce Control List of Items Controlled
List of Items Controlled)’’ appears in the List (CCL) to a Syrian foreign national. Related Controls: (1) The ground vehicles,
middle of the ECCN heading. Deemed exports and deemed reexports other articles, technical data (including
to Syrian foreign nationals involving software) and services described in 22 CFR
* * * * *
technology or source code subject to the part 121, Category VII are subject to the
EAR but not listed on the CCL do not jurisdiction of the International Traffic in
PART 740—[AMENDED] Arms Regulations. (2) See ECCN 0A919 for
require a license.
foreign-made ‘‘military commodities’’ that
■ 8. The authority citation for 15 CFR * * * * * incorporate more than a de minimis
part 740 continues to read as follows: amount of U.S.-origin ‘‘600 series’’
Authority: 50 U.S.C. 4601 et seq.; 50 U.S.C.
PART 774—[AMENDED] controlled content.
1701 et seq.; 22 U.S.C. 7201 et seq.; E.O. Related Definitions: N/A
13026, 61 FR 58767, 3 CFR, 1996 Comp., p. ■ 11. The authority citation for 15 CFR Items: a. Ground vehicles, whether manned
228; E.O. 13222, 66 FR 44025, 3 CFR, 2001 part 774 continues to read as follows: or unmanned, ‘‘specially designed’’ for a
Comp., p. 783; Notice of August 15, 2017, 82 Authority: 50 U.S.C. 4601 et seq.; 50 U.S.C. military use and not enumerated or
FR 39005 (August 16, 2017). 1701 et seq.; 10 U.S.C. 7420; 10 U.S.C. otherwise described in USML Category VII.
7430(e); 22 U.S.C. 287c, 22 U.S.C. 3201 et Note 1 to paragraph .a: For purposes of
■ 9. Section 740.20 is amended by seq.; 22 U.S.C. 6004; 42 U.S.C. 2139a; 15 paragraph .a, ‘‘ground vehicles’’ include (i)
revising paragraph (g)(1) to read as U.S.C. 1824a; 50 U.S.C. 4305; 22 U.S.C. 7201 tanks and armored vehicles manufactured
follows: et seq.; 22 U.S.C. 7210; E.O. 13026, 61 FR prior to 1956 that have not been modified
58767, 3 CFR, 1996 Comp., p. 228; E.O. since 1955 and that do not contain a
§ 740.20 License Exception Strategic
13222, 66 FR 44025, 3 CFR, 2001 Comp., p. functional weapon or a weapon capable of
Trade Authorization (STA).
783; Notice of August 15, 2017, 82 FR 39005 becoming functional through repair; (ii)
* * * * * (August 16, 2017). military railway trains except those that are
(g) * * * armed or are ‘‘specially designed’’ to launch
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■ 12. In supplement No. 1 to part 774,
missiles; (iii) unarmored military recovery
(1) Applicability. Any person may Category 0, ECCN 0A606 is revised to and other support vehicles; (iv) unarmored,
request License Exception STA read as follows: unarmed vehicles with mounts or hard
eligibility for end items described in points for firearms of .50 caliber or less; and
ECCN 0A606.a, ECCN 8A609.a, ECCNs Supplement No. 1 to Part 774—The
Commerce Control List (v) trailers ‘‘specially designed’’ for use with
8A620.a or .b, ‘‘spacecraft’’ in ECCNs other ground vehicles enumerated in USML
9A515.a.1, .a.2, .a.3, .a.4, or .g, 9A610.a, * * * * * Category VII or ECCN 0A606.a, and not
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![61158 Federal Register / Vol. 82, No. 247 / Wednesday, December 27, 2017 / Rules and Regulations
separately enumerated or otherwise g. through w. [RESERVED] Country Chart (See
described in USML Category VII. For x. ‘‘Parts,’’ ‘‘components,’’ ‘‘accessories,’’ Control(s) Supp. No. 1 to part
purposes of this note, the term ‘‘modified’’ and ‘‘attachments’’ that are ‘‘specially 738)
does not include incorporation of safety designed’’ for a commodity enumerated or
features required by law, cosmetic changes otherwise described in ECCN 0A606 (other NS applies to entire NS Column 1
(e.g., different paint or repositioning of bolt than 0A606.b or 0A606.y) or a defense article entry.
holes) or addition of ‘‘parts’’ or enumerated in USML Category VII and not RS applies to entire RS Column 1
‘‘components’’ available prior to 1956. elsewhere specified on the USML or in entry.
0A606.y. AT applies to entire AT Column 1
Note 2 to paragraph .a: A ground vehicle’s
being ‘‘specially designed’’ for military use entry.
Note 1: Forgings, castings, and other UN applies to entire See § 746.1(b) for UN
for purposes of determining controls under unfinished products, such as extrusions and
paragraph .a. entails a structural, electrical or entry. controls
machined bodies, that have reached a stage
mechanical feature involving one or more in manufacture where they are clearly List Based License Exceptions (See Part 740
‘‘components’’ that are ‘‘specially designed’’ identifiable by mechanical properties, for a description of all license exceptions)
for military use. Such ‘‘components’’ include:
material composition, geometry, or function CIV: N/A
a. Pneumatic tire casings of a kind
as commodities controlled by ECCN 0A606.x TSR: N/A
‘‘specially designed’’ to be bullet-proof;
b. Armored protection of vital ‘‘parts’’ (e.g., are controlled by ECCN 0A606.x.
Special Conditions for STA
fuel tanks or vehicle cabs); Note 2: ‘‘Parts,’’ ‘‘components,’’ STA: Paragraph (c)(2) of License Exception
c. Special reinforcements or mountings for ‘‘accessories’’ and ‘‘attachments’’ enumerated STA (§ 740.20(c)(2) of the EAR) may not be
weapons; in USML paragraph VII(g) are subject to the used for any ‘‘software’’ in 0D614.
d. Black-out lighting. controls of that paragraph. ‘‘Parts,’’
b. Other ground vehicles, ‘‘parts’’ and ‘‘components,’’ ‘‘accessories’’ and List of Items Controlled
‘‘components,’’ as follows: ‘‘attachments’’ described in ECCN 0A606.y Related Controls: (1) ‘‘Software’’ directly
b.1. Unarmed vehicles that are derived are subject to the controls of that paragraph. related to articles enumerated in USML
from civilian vehicles and that have all of the Category IX is subject to the control of
y. Specific ‘‘parts,’’ ‘‘components,’’
following: USML paragraph IX(e). (2) See ECCN
b.1.a. Manufactured or fitted with materials ‘‘accessories,’’ and ‘‘attachments’’ ‘‘specially 0A919 for foreign made ‘‘military
or ‘‘components’’ other than reactive or designed’’ for a commodity enumerated or commodities’’ that incorporate more than a
electromagnetic armor to provide ballistic otherwise described in this ECCN (other than de minimis amount of US-origin ‘‘600
protection to level III (National Institute of ECCN 0A606.b) or for a defense article in series’’ items.
Justice standard 0108.01, September 1985) or USML Category VII and not elsewhere Related Definitions: N/A
better; specified on the USML or the CCL, as Items:
b.1.b. A transmission to provide drive to follows, and ‘‘parts,’’ ‘‘components,’’ a. ‘‘Software’’ ‘‘specially designed’’ for the
both front and rear wheels simultaneously, ‘‘accessories,’’ and ‘‘attachments’’ ‘‘specially ‘‘development,’’ ‘‘production,’’ operation, or
including those vehicles having additional designed’’ therefor: maintenance of commodities controlled by
wheels for load bearing purposes whether y.1. Brake discs, rotors, drums, calipers, ECCNs 0A606 (except for ECCNs 0A606.b or
driven or not; cylinders, pads, shoes, lines, hoses, vacuum 0A606.y), 0B606, or 0C606.
b.1.c. Gross vehicle weight rating (GVWR) boosters, and parts therefor; b. [RESERVED]
greater than 4,500 kg; and y.2. Alternators and generators; ■ 14. In supplement No. 1 to part 774,
b.1.d. Designed or modified for off-road y.3. Axles; Category 0, ECCN 0E606 is revised to
use. y.4. Batteries; read as follows:
b.2. ‘‘Parts’’ and ‘‘components’’ having all y.5. Bearings (e.g., ball, roller, wheel);
of the following: y.6. Cables, cable assembles, and 0E606 ‘‘Technology’’ ‘‘required’’ for the
b.2.a. ‘‘Specially designed’’ for vehicles connectors; ‘‘development,’’ ‘‘production,’’ operation,
specified in paragraph .b.1 of this entry; and y.7. Cooling system hoses; installation, maintenance, repair, overhaul,
b.2.b. Providing ballistic protection to level y.8. Hydraulic, fuel, oil, and air filters, or refurbishing of ground vehicles and
III (National Institute of Justice standard other than those controlled by ECCN 1A004; related commodities in 0A606, 0B606,
0108.01, September 1985) or better. y.9. Gaskets and o-rings; 0C606, or software in 0D606 (see List of
Note 1 to paragraph b: Ground vehicles y.10. Hydraulic system hoses, fittings, Items Controlled).
otherwise controlled by 0A606.b.1 that couplings, adapters, and valves; License Requirements
contain reactive or electromagnetic armor are y.11. Latches and hinges;
subject to the controls of USML Category VII. Reason for Control: NS, RS, AT, UN
y.12. Lighting systems, fuses, and
Note 2 to paragraph b: ECCN 0A606.b.1 ‘‘components;’’
Country Chart (See
does not control civilian vehicles ‘‘specially y.13. Pneumatic hoses, fittings, adapters, Control(s) Supp. No. 1 to part
designed’’ for transporting money or couplings, and valves; 738)
valuables. y.14. Seats, seat assemblies, seat supports,
and harnesses; NS applies to entire NS Column 1
Note 3 to paragraph b: ‘‘Unarmed’’ means
y.15. Tires, except run flat; and entry.
not having installed weapons, installed
y.16. Windows, except those for armored RS applies to entire RS Column 1
mountings for weapons, or special
vehicles. entry.
reinforcements for mounts for weapons.
AT applies to entire AT Column 1
c. Air-cooled diesel engines and engine ■ 13. In supplement No. 1 to part 774, entry.
blocks for armored vehicles that weigh more Category 0, ECCN 0D606 is revised to UN applies to entire See § 746.1(b) for UN
than 40 tons. read as follows: entry. controls
d. Fully automatic continuously variable
transmissions for tracked combat vehicles. 0D606 ‘‘Software’’ ‘‘specially designed’’ for List Based License Exceptions (See Part 740
e. Deep water fording kits ‘‘specially the ‘‘development,’’ ‘‘production,’’ operation, for a description of all license exceptions)
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designed’’ for ground vehicles controlled by or maintenance of ground vehicles and CIV: N/A
ECCN 0A606.a or USML Category VII. related commodities controlled by 0A606, TSR: N/A
f. Self-launching bridge ‘‘components’’ not 0B606, or 0C606 (see List of Items
enumerated in USML Category VII(g) Controlled). Special Conditions for STA
‘‘specially designed’’ for deployment by STA: Paragraph (c)(2) of License Exception
ground vehicles enumerated in USML License Requirements STA (§ 740.20(c)(2) of the EAR) may not be
Category VII or this ECCN. Reason for Control: NS, RS, AT, UN used for any technology in 0E614.
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List of Items Controlled a.2.c. Mechanical-seal or inflatable-seal without necessarily achieving elimination of
Related Controls: ‘‘Technical data’’ directly walkthrough doors. all microbial infectivity or viability.
related to articles enumerated in USML b. Fermenters and components as follows: e. Steam, gas or vapor sterilizable freeze-
Category IX is subject to the control of b.1. Fermenters capable of cultivation of drying equipment with a condenser capacity
USML paragraph IX(e). micro-organisms or of live cells for the of 10 kg of ice or greater in 24 hours (10 liters
Related Definitions: N/A production of viruses or toxins, without the of water or greater in 24 hours) and less than
propagation of aerosols, having a capacity of 1000 kg of ice in 24 hours (less than 1,000
Items:
20 liters or greater. liters of water in 24 hours).
a. ‘‘Technology’’ ‘‘required’’ for the
b.2. Components designed for such f. Spray-drying equipment capable of
‘‘development,’’ ‘‘production,’’ operation,
fermenters, as follows: drying toxins or pathogenic microorganisms
installation, maintenance, repair, overhaul,
b.2.a. Cultivation chambers designed to be having all of the following characteristics:
or refurbishing of commodities enumerated
sterilized or disinfected in situ; f.1. A water evaporation capacity of ≥ 0.4
or otherwise described in ECCN 0A606
b.2.b. Cultivation chamber holding devices; kg/h and ≤ 400 kg/h;
(except for ECCNs 0A606.b or 0A606.y),
or f.2. The ability to generate a typical mean
0B606, or 0C606.
b.2.c. Process control units capable of product particle size of ≤ 10 micrometers
b. [RESERVED] simultaneously monitoring and controlling with existing fittings or by minimal
■ 15. In supplement No. 1 to part 774, two or more fermentation system parameters modification of the spray-dryer with
Category 2, ECCN 2B352 is revised to (e.g., temperature, pH, nutrients, agitation, atomization nozzles enabling generation of
read as follows: dissolved oxygen, air flow, foam control). the required particle size; and
Technical Note: Fermenters include f.3. Capable of being sterilized or
2B352 Equipment capable of use in bioreactors (including single-use (disposable) disinfected in situ.
handling biological materials, as follows (see bioreactors), chemostats and continuous-flow g. Protective and containment equipment,
List of Items Controlled). systems. as follows:
c. Centrifugal separators capable of the g.1. Protective full or half suits, or hoods
License Requirements dependent upon a tethered external air
continuous separation of pathogenic
Reason for Control: CB, AT microorganisms, without the propagation of supply and operating under positive
aerosols, and having all of the following pressure;
Country Chart (See characteristics: Technical Note: This entry does not
Control(s) Supp. No. 1 to part c.1. One or more sealing joints within the control suits designed to be worn with self-
738). steam containment area; contained breathing apparatus.
c.2. A flow rate greater than 100 liters per g.2. Biocontainment chambers, isolators, or
CB applies to entire CB Column 2 biological safety cabinets having all of the
hour;
entry. following characteristics, for normal
c.3. ‘‘Parts’’ or ‘‘components’’ of polished
AT applies to entire AT Column 1 operation:
stainless steel or titanium; and
entry. c.4. Capable of in-situ steam sterilization in g.2.a. Fully enclosed workspace where the
List Based License Exceptions (See Part 740 a closed state. operator is separated from the work by a
for a description of all license exceptions) Technical Note: Centrifugal separators physical barrier;
include decanters. g.2.b. Able to operate at negative pressure;
LVS: N/A g.2.c. Means to safely manipulate items in
d. Cross (tangential) flow filtration
GBS: N/A the workspace; and
equipment and ‘‘accessories,’’ as follows:
CIV: N/A g.2.d. Supply and exhaust air to and from
d.1. Cross (tangential) flow filtration
List of Items Controlled equipment capable of separation of the workspace is high-efficiency particulate
microorganisms, viruses, toxins or cell air (HEPA) filtered.
Related Controls: See ECCNs 1A004 and
1A995 for protective equipment that is not cultures having all of the following Note 1 to 2B352.g.2: 2B352.g.2 controls
characteristics: class III biosafety cabinets, as specified in the
covered by this entry. Also see ECCN
d.1.a. A total filtration area equal to or WHO Laboratory Biosafety Manual (3rd
9A120 for controls on certain ‘‘UAV’’
greater than 1 square meter (1 m2); and edition, Geneva, 2004) or constructed in
systems designed or modified to dispense
d.1.b. Having any of the following accordance with national standards,
an aerosol and capable of carrying
characteristics: regulations or guidance.
elements of a payload in the form of a
d.1.b.1. Capable of being sterilized or
particulate or liquid, other than fuel Note 2 to 2B352.g.2: 2B352.g.2 does not
disinfected in-situ; or
‘‘parts’’ or ‘‘components’’ of such vehicles, control isolators ‘‘specially designed’’ for
d.1.b.2. Using disposable or single-use
of a volume greater than 20 liters. barrier nursing or transportation of infected
filtration ‘‘parts’’ or ‘‘components’’.
Related Definitions: (1) ‘‘Lighter than air patients.
N.B.: 2B352.d.1 does not control reverse
vehicles’’—balloons and airships that rely osmosis and hemodialysis equipment, as h. Aerosol inhalation equipment designed
on hot air or on lighter-than-air gases, such specified by the manufacturer. for aerosol challenge testing with
as helium or hydrogen, for their lift. (2) d.2. Cross (tangential) flow filtration microorganisms, viruses or toxins, as follows:
‘‘UAVs’’—Unmanned Aerial Vehicles. (3) ‘‘parts’’ or ‘‘components’’ (e.g., modules, h.1. Whole-body exposure chambers
‘‘VMD’’—Volume Median Diameter. elements, cassettes, cartridges, units or having a capacity of 1 cubic meter or greater.
Items: plates) with filtration area equal to or greater h.2. Nose-only exposure apparatus
a. Containment facilities and related than 0.2 square meters (0.2 m2) for each utilizing directed aerosol flow and having a
equipment, as follows: component and designed for use in cross capacity for the exposure of 12 or more
a.1. Complete containment facilities at P3 (tangential) flow filtration equipment rodents, or two or more animals other than
or P4 containment level. controlled by 2B352.d.1. rodents, and closed animal restraint tubes
Technical Note: P3 or P4 (BL3, BL4, L3, TECHNICAL NOTE: In this ECCN, designed for use with such apparatus.
L4) containment levels are as specified in the ‘‘sterilized’’ denotes the elimination of all i. Spraying or fogging systems and ‘‘parts’’
WHO Laboratory Biosafety Manual (3rd viable microbes from the equipment through and ‘‘components’’ therefor, as follows:
edition, Geneva, 2004). the use of either physical (e.g., steam) or i.1. Complete spraying or fogging systems,
a.2. Equipment designed for fixed chemical agents. ‘‘Disinfected’’ denotes the ‘‘specially designed’’ or modified for fitting
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installation in containment facilities destruction of potential microbial infectivity to ‘‘aircraft,’’ ‘‘lighter than air vehicles,’’ or
specified in paragraph a.1 of this ECCN, as in the equipment through the use of chemical ‘‘UAVs,’’ capable of delivering, from a liquid
follows: agents with a germicidal effect. suspension, an initial droplet ‘VMD’ of less
a.2.a. Double-door pass-through ‘‘Disinfection’’ and ‘‘sterilization’’ are than 50 microns at a flow rate of greater than
decontamination autoclaves; distinct from ‘‘sanitization’’, the latter 2 liters per minute;
a.2.b. Breathing air suit decontamination referring to cleaning procedures designed to i.2. Spray booms or arrays of ‘aerosol
showers; lower the microbial content of equipment generating units’, ‘‘specially designed’’ or
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modified for fitting to ‘‘aircraft,’’ ‘‘lighter subject to the jurisdiction of the in manufacturing where they are clearly
than air vehicles,’’ or ‘‘UAVs,’’ capable of International Traffic in Arms Regulations. identifiable by mechanical properties,
delivering, from a liquid suspension, an (2) See ECCN 0A919 for foreign-made material composition, geometry, or function
initial droplet ‘VMD’ of less than 50 microns ‘‘military commodities’’ that incorporate as commodities controlled by ECCN 8A609.x
at a flow rate of greater than 2 liters per more than a de minimis amount of U.S.- are controlled by ECCN 8A609.x.
minute; origin ‘‘600 series’’ controlled content. (3)
i.3. ‘Aerosol generating units’ ‘‘specially For controls on diesel engines and electric Note 2: ‘‘Parts,’’ ‘‘components,’’
designed’’ for fitting to the systems specified motors that are ‘‘subject to the EAR’’ for ‘‘accessories’’ and ‘‘attachments’’ specified in
in paragraphs i.1 or i.2 of this ECCN. surface vessels of war ‘‘subject to the EAR’’ USML subcategory VI(f) are subject to the
Technical Notes: or ‘‘subject to the ITAR,’’ see ECCN controls of that paragraph. ‘‘Parts,’’
1. ‘Aerosol generating units’ are devices 8A992.g. For diesel engines and electric ‘‘components,’’ ‘‘accessories,’’ and
‘‘specially designed’’ or modified for fitting motors for surface vessels of war ‘‘subject ‘‘attachments’’ specified in ECCN 8A609.y
to ‘‘aircraft’’ and include nozzles, rotary to the ITAR,’’ see 22 CFR part 121, are subject to the controls of that paragraph.
drum atomizers and similar devices. Category VI(c) for parts, components, y. Specific ‘‘parts,’’ ‘‘components,’’
2. This ECCN does not control spraying or accessories, and attachments, ‘‘specially
‘‘accessories’’ and ‘‘attachments’’ ‘‘specially
fogging systems, ‘‘parts’’ and ‘‘components,’’ designed’’ for developmental vessels
designed’’ for a commodity subject to control
as specified in 2B352.i, that are demonstrated funded by the Department of Defense via
contract or other funding authorization. (4) in this ECCN or for a defense article in USML
not to be capable of delivering biological
For controls on military gas turbine Category VI and not elsewhere specified in
agents in the form of infectious aerosols.
engines and related items for vessels of the USML, as follows, and ‘‘parts,’’
3. Volume Median Diameter ‘VMD’ for
droplets produced by spray equipment or war, see ECCN 9A619. ‘‘components,’’ ‘‘accessories,’’ and
nozzles ‘‘specially designed’’ for use on Related Definitions: N/A ‘‘attachments’’ ‘‘specially designed’’ therefor:
‘‘aircraft’’ or ‘‘UAVs’’ should be measured Items: y.1. Public address (PA) systems;
using either of the following methods a. Surface vessels of war ‘‘specially y.2. Filters and filter assemblies, hoses,
(pending the adoption of internationally designed’’ for a military use and not lines, fittings, couplings, and brackets for
accepted standards): enumerated or otherwise described in the pneumatic, hydraulic, oil and fuel systems;
a. Doppler ‘‘laser’’ method, USML. y.3. Galleys;
b. Forward ‘‘laser’’ diffraction method. Note 1: 8A609.a includes: (i) Underway y.4. Lavatories;
■ 16. In supplement No. 1 to part 774, replenishment ships; (ii) surface vessel and y.5. Magnetic compass, magnetic azimuth
submarine tender and repair ships, except detector;
Category 8, ECCN 8A609 is revised to
vessels that are ‘‘specially designed’’ to y.6. Medical facilities;
read as follows: y.7. Potable water tanks, filters, valves,
support naval nuclear propulsion plants; (iii)
8A609 Surface vessels of war and related non-submersible submarine rescue ships; (iv) hoses, lines, fittings, couplings, and brackets;
commodities (see List of Items Controlled) other auxiliaries (e.g., AGDS, AGF, AGM, y.8. Panel knobs, indicators, switches,
AGOR, AGOS, AH, AP, ARL, AVB, AVM, buttons, and dials whether unfiltered or
License Requirements
and AVT); (v) amphibious warfare craft, filtered for use with night vision imaging
Reason for Control: NS, RS, AT, UN except those that are armed; and (vi) systems;
unarmored and unarmed coastal, patrol, y.9. Emergency lighting;
Country Chart (See roadstead, and Coast Guard and other patrol y.10. Gauges and indicators;
Control(s) Supp. No. 1 to part craft with mounts or hard points for firearms y.11. Audio selector panels.
738) of .50 caliber or less.
Note 2: For purposes of paragraph .a,
■ 17. In supplement No. 1 to part 774,
NS applies to entire NS Column 1
entry, except surface vessels of war includes vessels Category 9, ECCN 9A610 is revised to
8A609.y. ‘‘specially designed’’ for military use that are read as follows.
RS applies to entire RS Column 1 not identified in paragraph (a) of ITAR
entry, except § 121.15, including any demilitarized vessels, 9A610 Military aircraft and related
8A609.y. regardless of origin or designation, commodities, other than those enumerated
AT applies to entire AT Column 1 manufactured prior to 1950 and that have not in 9A991.a (see List of Items Controlled)
entry. been modified since 1949. For purposes of License Requirements
UN applies to entire See § 746.1(b) for UN this note, the term modified does not include
entry, except controls incorporation of safety features required by Reason for Control: NS, RS, MT, AT, UN
8A609.y. law, cosmetic changes (e.g., different paint),
or the addition of ‘‘parts’’ or ‘‘components’’ Country Chart (See
List Based License Exceptions (See Part 740 available prior to 1950. Control(s) Supp. No. 1 to part
for a description of all license exceptions) 738)
b. Non-magnetic diesel engines with a
LVS: $1500 power output of 50 hp or more and either of
GBS: N/A NS applies to entire NS Column 1
the following: entry except:
CIV: N/A b.1. Non-magnetic content exceeding 25% 9A610.b; parts and
Special Conditions for STA of total weight; or components con-
b.2. Non-magnetic parts other than trolled in 9A610.x if
STA: (1) Paragraph (c)(1) of License
crankcase, block, head, pistons, covers, end being exported or
Exception STA (§ 740.20(c)(1) of the EAR)
plates, valve facings, gaskets, and fuel, reexported for use
may not be used for any item in 8A609.a,
lubrication and other supply lines. in an aircraft con-
unless determined by BIS to be eligible for
c. through w. [RESERVED] trolled in 9A610.b;
License Exception STA in accordance with
x. ‘‘Parts,’’ ‘‘components,’’ ‘‘accessories’’ and 9A610.y.
§ 740.20(g) (License Exception STA
eligibility requests for 9x515 and ‘‘600 and ‘‘attachments’’ that are ‘‘specially RS applies to entire RS Column 1
series’’ items). designed’’ for a commodity enumerated or entry except:
otherwise described in ECCN 8A609 (except 9A610.b; parts and
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List of Items Controlled for 8A609.y) or a defense article enumerated components con-
Related Controls: (1) Surface vessels of war or otherwise described in USML Category VI trolled in 9A610.x if
and special naval equipment, and technical and not specified elsewhere on the USML, in being exported or
data (including software), and services 8A609.y or 3A611.y. reexported for use
directly related thereto, described in 22 Note 1: Forgings, castings, and other in an aircraft con-
CFR part 121, Category VI, Surface Vessels unfinished products, such as extrusions and trolled in 9A610.b;
of War and Special Naval Equipment, are machined bodies, that have reached a stage and 9A610.y.
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![Federal Register / Vol. 82, No. 247 / Wednesday, December 27, 2017 / Rules and Regulations 61161
Country Chart (See standards of a Wassenaar Arrangement drones controlled by either USML paragraph
Control(s) Supp. No. 1 to part Participating State; and VIII(a) or ECCN 9A610.a. that are not capable
738) c. Do not incorporate weapons enumerated of delivering at least 500 kilograms payload
or otherwise described on the U.S. Munitions to a range of at least 300 km are controlled
MT applies to MT Column 1 List, unless inoperable and incapable of in paragraph .x of this entry.
9A610.t, .u, .v, and being returned to operation. w. Pneumatic hydraulic, mechanical,
.w. b. L–100 aircraft manufactured prior to electro-optical, or electromechanical flight
AT applies to entire AT Column 1 2013. control systems (including fly-by-wire and
entry. c.–d. [Reserved] fly-by-light systems) and attitude control
UN applies to entire See § 746.1(b) for UN e. Mobile aircraft arresting and engagement equipment designed or modified for UAVs or
entry except controls runway systems for aircraft controlled by drones controlled by either USML paragraph
9A610.y. either USML Category VIII(a) or ECCN VIII(a) or ECCN 9A610.a., and capable of
9A610.a. delivering at least 500 kilograms payload to
List Based License Exceptions (See Part 740
f. Pressure refueling equipment and a range of at least 300 km.
for a description of all license exceptions)
equipment that facilitates operations in Note to paragraph .w: Pneumatic,
LVS: $1500 confined areas, ‘‘specially designed’’ for hydraulic, mechanical, electro-optical, or
GBS: N/A aircraft controlled by either USML paragraph electromechanical flight control systems
CIV: N/A VIII(a) or ECCN 9A610.a. (including fly-by-wire and fly-by-light
g. Aircrew life support equipment, aircrew systems) and attitude control equipment
Special Conditions For STA
safety equipment and other devices for designed or modified for UAVs or drones
STA: (1) Paragraph (c)(1) of License emergency escape from aircraft controlled by controlled by either USML paragraph VIII(a)
Exception STA (§ 740.20(c)(1) of the EAR) either USML paragraph VIII(a) or ECCN or ECCN 9A610.a., not capable of delivering
may not be used for any item in 9A610.a 9A610.a. at least 500 kilograms payload to a range of
(i.e., ‘‘end item’’ military aircraft), unless h. Parachutes, paragliders, complete at least 300 km are controlled in paragraph
determined by BIS to be eligible for parachute canopies, harnesses, platforms, .x of this entry.
License Exception STA in accordance with electronic release mechanisms, ‘‘specially
§ 740.20(g) (License Exception STA designed’’ for use with aircraft controlled by x. ‘‘Parts,’’ ‘‘components,’’ ‘‘accessories,’’
eligibility requests for 9x515 and ‘‘600 either USML paragraph VIII(a) or ECCN and ‘‘attachments’’ that are ‘‘specially
series’’ items). (2) Paragraph (c)(2) of 9A610.a, and ‘‘equipment’’ ‘‘specially designed’’ for a commodity enumerated or
License Exception STA (§ 740.20(c)(2) of designed’’ for military high altitude otherwise described in ECCN 9A610 (except
the EAR) may not be used for any item in parachutists, such as suits, special helmets, for 9A610.y) or a defense article enumerated
9A610. breathing systems, and navigation or otherwise described in USML Category
equipment. VIII and not elsewhere specified on the
List of Items Controlled USML or in 9A610.y, 9A619.y, or 3A611.y.
i. Controlled opening equipment or
Related Controls: (1) Military aircraft and automatic piloting systems, designed for y. Specific ‘‘parts,’’ ‘‘components,’’
related articles that are enumerated in parachuted loads. ‘‘accessories,’’ and ‘‘attachments’’ ‘‘specially
USML Category VIII, and technical data j. Ground effect machines (GEMS), designed’’ for a commodity subject to control
(including software) directly related including surface effect machines and air in this entry, ECCN 9A619, or for a defense
thereto, are subject to the ITAR. (2) See cushion vehicles, ‘‘specially designed’’ for article in USML Categories VIII or XIX and
ECCN 0A919 for controls on foreign-made use by a military. not elsewhere specified in the USML or the
‘‘military commodities’’ that incorporate k. through s. [Reserved] CCL, and other aircraft commodities
more than a de minimis amount of U.S.- t. Composite structures, laminates, and ‘‘specially designed’’ for a military use, as
origin ‘‘600 series’’ controlled content. (3) manufactures thereof ‘‘specially designed’’ follows, and ‘‘parts,’’ ‘‘components,’’
See USML Category XIX and ECCN 9A619 for unmanned aerial vehicles controlled ‘‘accessories,’’ and ‘‘attachments’’ ‘‘specially
for controls on military aircraft gas turbine under USML Category VIII(a) with a range designed’’ therefor:
engines and related items. equal to or greater than 300 km. y.1. Aircraft tires;
Related Definitions: In paragraph .y of this Note to paragraph .t: Composite structures, y.2. Analog gauges and indicators;
entry, the term ‘fluid’ includes liquids and laminates, and manufactures thereof y.3. Audio selector panels;
gases. ‘‘specially designed’’ for unmanned aerial y.4. Check valves for hydraulic and
Items: vehicles controlled under USML Category pneumatic systems;
a. ‘Military Aircraft’ ‘‘specially designed’’ VIII(a) with a maximum range less than 300 y.5. Crew rest equipment;
for a military use that are not enumerated in km are controlled in paragraph .x of this y.6. Ejection seat mounted survival aids;
USML paragraph VIII(a). entry. y.7. Energy dissipating pads for cargo (for
pads made from paper or cardboard);
Note 1: For purposes of paragraph .a the u. Apparatus and devices ‘‘specially
y.8. Fluid filters and filter assemblies;
term ‘military aircraft’ means the LM–100J designed’’ for the handling, control,
y.9. Galleys;
aircraft and any aircraft ‘‘specially designed’’ activation and non-ship-based launching of
y.10. Fluid hoses, straight and unbent lines
for a military use that are not enumerated in UAVs or drones controlled by either USML
paragraph VIII(a) or ECCN 9A610.a, and (for a commodity subject to control in this
USML paragraph VIII(a). The term includes: entry or defense article in USML Category
Trainer aircraft; cargo aircraft; utility fixed capable of a range equal to or greater than
300 km. VIII), and fittings, couplings, clamps (for a
wing aircraft; military helicopters; commodity subject to control in this entry or
observation aircraft; military non-expansive Note to paragraph .u: Apparatus and defense article in USML Category VIII) and
balloons and other lighter than air aircraft; devices ‘‘specially designed’’ for the brackets therefor;
and unarmed military aircraft, regardless of handling, control, activation and non-ship- y.11. Lavatories;
origin or designation. Aircraft with based launching of UAVs or drones y.12. Life rafts;
modifications made to incorporate safety of controlled by either USML paragraph VIII(a) y.13. Magnetic compass, magnetic azimuth
flight features or other FAA or NTSB or ECCN 9A610.a with a maximum range less detector;
modifications such as transponders and air than 300 km are controlled in paragraph .x y.14. Medical litter provisions;
data recorders are ‘‘unmodified’’ for the of this entry. y.15. Cockpit or cabin mirrors;
purposes of this paragraph .a. v. Radar altimeters designed or modified y.16. Passenger seats including palletized
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Note 2: 9A610.a does not control ‘military for use in UAVs or drones controlled by seats;
aircraft’ that: either USML paragraph VIII(a) or ECCN y.17. Potable water storage systems;
a. Were first manufactured before 1946; 9A610.a., and capable of delivering at least y.18. Public address (PA) systems;
b. Do not incorporate defense articles 500 kilograms payload to a range of at least y.19. Steel brake wear pads (does not
enumerated or otherwise described on the 300 km. include sintered mix or carbon/carbon
U.S. Munitions List, unless the items are Note to paragraph .v: Radar altimeters materials);
required to meet safety or airworthiness designed or modified for use in UAVs or y.20. Underwater locator beacons;
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![61162 Federal Register / Vol. 82, No. 247 / Wednesday, December 27, 2017 / Rules and Regulations
y.21. Urine collection bags/pads/cups/ DATES: This order is effective December process by adding a second procedure
pumps; 27, 2017. The classification was (Pub. L. 112–144). A device sponsor
y.22. Windshield washer and wiper applicable on November 19, 2013. may utilize either procedure for De
systems;
FOR FURTHER INFORMATION CONTACT: Novo classification.
y.23. Filtered and unfiltered panel knobs,
indicators, switches, buttons, and dials; Steven Tjoe, Center for Devices and Under the first procedure, the person
y.24. Lead-acid and Nickel-Cadmium Radiological Health, Food and Drug submits a 510(k) for a device that has
batteries; Administration, 10903 New Hampshire not previously been classified. After
y.25. Propellers, propeller systems, and Ave., Bldg. 66, Rm. 4550, Silver Spring, receiving an order from FDA classifying
propeller blades used with reciprocating MD 20993–0002, 301–796–5866, the device into class III under section
engines; 513(f)(1) of the FD&C Act, the person
y.26. Fire extinguishers;
steven.tjoe@fda.hhs.gov.
then requests a classification under
y.27. Flame and smoke/CO2 detectors; SUPPLEMENTARY INFORMATION:
section 513(f)(2).
y.28. Map cases; Under the second procedure, rather
y.29. ‘Military Aircraft’ that were first I. Background
manufactured from 1946 to 1955 that do not
than first submitting a 510(k) and then
Upon request, FDA has classified the
incorporate defense articles enumerated or a request for classification, if the person
reagents for molecular diagnostic
otherwise described on the U.S. Munitions determines that there is no legally
instrument test systems as class I
List, unless the items are required to meet marketed device upon which to base a
(general controls), which we have determination of substantial
safety or airworthiness standards of a
Wassenaar Arrangement Participating State; determined will provide a reasonable equivalence, that person requests a
and do not incorporate weapons enumerated assurance of safety and effectiveness. In classification under section 513(f)(2) of
or otherwise described on the U.S. Munitions addition, we believe this action will the FD&C Act.
List, unless inoperable and incapable of enhance patients’ access to beneficial Under either procedure for De Novo
being returned to operation; innovation, in part by reducing classification, FDA is required to
y.30. ‘‘Parts,’’ ‘‘components,’’ regulatory burdens by placing the
‘‘accessories,’’ and ‘‘attachments,’’ other than classify the device by written order
device into a lower device class than the within 120 days. The classification will
electronic items or navigation equipment, for
automatic class III assignment. be according to the criteria under
use in or with a commodity controlled by
ECCN 9A610.h; The automatic assignment of class III section 513(a)(1) of the FD&C Act.
y.31. Identification plates and nameplates; occurs by operation of law and without Although the device was automatically
and any action by FDA, regardless of the placed within class III, the De Novo
y.32. Fluid manifolds. level of risk posed by the new device. classification is considered to be the
Dated: December 18, 2017. Any device that was not in commercial initial classification of the device.
Richard E. Ashooh,
distribution before May 28, 1976, is We believe this De Novo classification
automatically classified as, and remains will enhance patients’ access to
Assistant Secretary for Export
Administration.
within, class III and requires premarket beneficial innovation, in part by
approval unless and until FDA takes an reducing regulatory burdens. When FDA
[FR Doc. 2017–27616 Filed 12–26–17; 8:45 am]
action to classify or reclassify the device classifies a device into class I or II via
BILLING CODE 3510–33–P
(see 21 U.S.C. 360c(f)(1)). We refer to the De Novo process, the device can
these devices as ‘‘postamendments serve as a predicate for future devices of
devices’’ because they were not in that type, including for 510(k)s (see 21
DEPARTMENT OF HEALTH AND commercial distribution prior to the
HUMAN SERVICES U.S.C. 360c(f)(2)(B)(i)). As a result, other
date of enactment of the Medical Device device sponsors do not have to submit
Amendments of 1976, which amended a De Novo request or premarket
Food and Drug Administration
the Federal Food, Drug, and Cosmetic approval application in order to market
Act (FD&C Act). a substantially equivalent device (see 21
21 CFR Part 862
FDA may take a variety of actions in U.S.C. 360c(i), defining ‘‘substantial
[Docket No. FDA–2017–N–6593] appropriate circumstances to classify or equivalence’’). Instead, sponsors can use
reclassify a device into class I or II. We the less-burdensome 510(k) process,
Medical Devices; Clinical Chemistry may issue an order finding a new device
and Clinical Toxicology Devices; when necessary, to market their device.
to be substantially equivalent under
Classification of the Reagents for section 513(i) of the FD&C Act (21 II. De Novo Classification
Molecular Diagnostic Instrument Test U.S.C. 360c(i)) to a predicate device that On October 4, 2013, Illumina, Inc.,
Systems does not require premarket approval. submitted a request for De Novo
AGENCY: Food and Drug Administration, We determine whether a new device is classification of the MiSeqDx Universal
HHS. substantially equivalent to a predicate Kit 1.0. FDA reviewed the request in
ACTION: Final order. by means of the procedures for order to classify the device under the
premarket notification under section criteria for classification set forth in
SUMMARY: The Food and Drug 510(k) of the FD&C Act (21 U.S.C. section 513(a)(1) of the FD&C Act.
Administration (FDA or we) is 360(k)) and part 807 (21 CFR part 807). We classify devices into class I if
classifying the reagents for molecular FDA may also classify a device general controls are sufficient to provide
diagnostic instrument test systems into through ‘‘De Novo’’ classification, a reasonable assurance of the safety and
class I (general controls). We are taking common name for the process effectiveness of the device for its
this action because we have determined authorized under section 513(f)(2) of the intended use (see 21 U.S.C.
that classifying the device into class I FD&C Act. Section 207 of the Food and 360c(a)(1)(A)). After review of the
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(general controls) will provide a Drug Administration Modernization Act information submitted in the request,
reasonable assurance of safety and of 1997 established the first procedure we determined that the device can be
effectiveness of the device. We believe for De Novo classification (Pub. L. 105– classified into class I. FDA has
this action will also enhance patients’ 115). Section 607 of the Food and Drug determined that general controls will
access to beneficial innovative devices, Administration Safety and Innovation provide reasonable assurance of the
in part by reducing regulatory burdens. Act modified the De Novo application safety and effectiveness of the device.
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Document Created: 2017-12-27 02:22:58
Document Modified: 2017-12-27 02:22:58
| Category | Regulatory Information | |
| Collection | Federal Register | |
| sudoc Class | AE 2.7: GS 4.107: AE 2.106: | |
| Publisher | Office of the Federal Register, National Archives and Records Administration | |
| Section | Rules and Regulations | |
| Action | Final rule; correcting amendments. | |
| Dates | This rule is effective December 27, 2017. | |
| Contact | Ivan Mogensen, Office of Exporter Services, Bureau of Industry and Security, by telephone: (202) 482-2440 or email: [email protected] | |
| FR Citation | 82 FR 61153 | |
| RIN Number | 0694-AH31 | |
| CFR Citation | 15
CFR
732 15 CFR 734 15 CFR 738 15 CFR 740 15 CFR 746 15 CFR 774 | |
| CFR Associated | Administrative Practice and Procedure; Exports; Reporting and Recordkeeping Requirements; Inventions and Patents; Research and Science and Technology |
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