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329–4090; email: [email protected]. information on the availability of this Phone: 202–482–5991; Email: ERC@ Before using any approved AMOC on any material at the FAA, call (816) 329–4148. It bis.doc.gov. balloon to which the AMOC applies, notify is also available on the Internet at http:// your appropriate principal inspector (PI) in www.regulations.gov by searching for SUPPLEMENTARY INFORMATION: the FAA Flight Standards District Office locating Docket No. FAA–2016–8989. (FSDO), or lacking a PI, your local FSDO. (6) You may view this service information Background (2) Airworthy Product: For any requirement that is incorporated by reference at the in this AD to obtain corrective actions from National Archives and Records Authorization Validated End-User a manufacturer or other source, use these Administration (NARA). For information on actions if they are FAA-approved. Corrective the availability of this material at NARA, call Validated End-Users (VEUs) are actions are considered FAA-approved if they 202–741–6030, or go to: http:// designated entities located in eligible are approved by the State of Design Authority www.archives.gov/federal-register/cfr/ibr- destinations to which eligible items may (or their delegated agent). You are required locations.html. be exported, reexported, or transferred to assure the product is airworthy before it (in-country) under a general is returned to service. Issued in Kansas City, Missouri, on August (3) Reporting Requirements: For any 30, 2016. authorization instead of a license. The reporting requirement in this AD, a federal Pat Mullen, names of the VEUs, as well as the dates agency may not conduct or sponsor, and a Acting Manager, Small Airplane Directorate, they were so designated, and their person is not required to respond to, nor Aircraft Certification Service. respective eligible destinations shall a person be subject to a penalty for [FR Doc. 2016–21409 Filed 9–2–16; 8:45 am] (facilities) and items are identified in failure to comply with a collection of supplement No. 7 to part 748 of the information subject to the requirements of BILLING CODE 4910–13–P the Paperwork Reduction Act unless that EAR. Under the terms described in that collection of information displays a current supplement, VEUs may obtain eligible valid OMB Control Number. The OMB DEPARTMENT OF COMMERCE items without an export license from Control Number for this information BIS, in conformity with § 748.15 of the collection is 2120–0056. Public reporting for Bureau of Industry and Security EAR. Eligible items vary between VEUs this collection of information is estimated to and may include commodities, software, be approximately 5 minutes per response, including the time for reviewing instructions, 15 CFR Part 748 and technology, except those controlled for missile technology or crime control completing and reviewing the collection of [Docket No. 160810722–6722–01] information. All responses to this collection reasons on the Commerce Control List of information are mandatory. Comments RIN 0694–AH05 (CCL) (part 774 of the EAR). concerning the accuracy of this burden and VEUs are reviewed and approved by suggestions for reducing the burden should Amendments to Existing Validated be directed to the FAA at: 800 Independence End-User Authorization in the People’s the U.S. Government in accordance with Ave. SW., Washington, DC 20591, Attn: Republic of China: Boeing Tianjin the provisions of § 748.15 and Information Collection Clearance Officer, Composites Co. Ltd. supplement Nos. 8 and 9 to part 748 of AES–200. the EAR. The End-User Review (h) Special Flight Permit AGENCY: Bureau of Industry and Committee (ERC), composed of Special flight permits are prohibited. Security, Commerce. representatives from the Departments of ACTION: Final rule. State, Defense, Energy, Commerce, and (i) Related Information other agencies as appropriate, is Refer to MCAI European Aviation Safety SUMMARY: In this rule, the Bureau of responsible for administering the VEU Agency (EASA) AD No. 2016–0151, dated Industry and Security (BIS) amends the July 26, 2016, for related information. You program. BIS amended the EAR in a Export Administration Regulations final rule published on June 19, 2007 may examine the MCAI on the Internet at (EAR) to revise the existing Validated (72 FR 33646), to create Authorization http://www.regulations.gov by searching for End-User (VEU) list for the People’s and locating Docket No. FAA–2016–8989. VEU. Republic of China (PRC) by updating the (j) Material Incorporated by Reference list of eligible destinations (facilities) for Amendment to Existing VEU (1) The Director of the Federal Register VEU Boeing Tianjin Composites Co. Ltd. Authorization for Boeing Tianjin approved the incorporation by reference (BTC). Specifically, BIS amends Composites Co. Ltd. (BTC) in the (IBR) of the service information listed in this supplement No. 7 to part 748 of the EAR People’s Republic of China paragraph under 5 U.S.C. 552(a) and 1 CFR to change the written address of BTC’s part 51. existing facility. The physical location Revision to the List of ‘‘Eligible (2) You must use this service information Destinations’’ for BTC as applicable to do the actions required by of the facility has not changed. BIS updated the facility address after this AD, unless this AD specifies otherwise. In this rule, BIS amends supplement receiving notification of the change from (3) The following service information was No. 7 to part 748 to revise BTC’s VEU approved for IBR on August 29, 2016 (81 FR BTC. The End-User Review Committee 57449, August 23, 2016). reviewed and authorized the authorization. Specifically, in this rule, (i) BALO´ NY KUBI´Cˇ EK spol. s r.o. Service amendment in accordance with BIS updates the written address of Bulletin No. BB/50, BB–S/11, AB24 rev.1, established procedures. The updated BTC’s facility in the People’s Republic dated May 12, 2016. address contributes to maintaining of China to which the company’s (ii) Reserved. ´ ´ ˇ accurate location information for BTC’s eligible items may be exported, (4) For BALONY KUBICEK spol. s r.o. reexported or transferred (in-country). service information identified in this AD, VEU. contact BALO´ NY KUBI´Cˇ EK spol. s r. o., Jarnı´ DATES: This rule is effective September The physical location of the facility has 2a, 614 00 Brno, Czech Republic, telephone: 6, 2016. not changed. +420 545 422 620; fax: +420 545 422 621; FOR FURTHER INFORMATION CONTACT: The amendment to the address of email: [email protected]. Internet: BTC’s facility is in response to a request http://www.kubicekballoons.eu. Chair, End-User Review Committee, (5) You may view this service information Office of the Assistant Secretary, Export from BTC. This amendment was at the FAA, Small Airplane Directorate, 901 Administration, Bureau of Industry and approved by the ERC. The revision is as Locust, Kansas City, Missouri 64106. For Security, U.S. Department of Commerce, follows:

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Revision to Address of BTC’s Eligible required to respond to, nor be subject to through an interagency review process, Destination (Facility) a penalty for failure to comply with a the authorizations granted under the Current address: Boeing Tianjin collection of information subject to the VEU program involve interagency Composites Co. Ltd., No. 4–388 Hebei requirements of the PRA, unless that deliberation and result from review of Road, Tanggu Tianjin, China. collection of information displays a public and non-public sources, currently valid OMB Control Number. New address: Boeing Tianjin including licensing data, and the 3. This rule does not contain policies Composites Co. Ltd., 4566 Hebei Road, measurement of such information with Federalism implications as that against the VEU authorization criteria. Marine Hi-Tech Development Area, term is defined under Executive Order Tanggu District, Tianjin, China 300451. Given the nature of the review, and in 13132. light of the parallels between the VEU Export Administration Act 4. Pursuant to the Administrative application review process and the Procedure Act (APA), 5 U.S.C. review of license applications, public Although the Export Administration 553(b)(B), BIS finds good cause to waive Act expired on August 20, 2001, the comment on this authorization and the otherwise applicable requirement subsequent amendments prior to President, through Executive Order that this rule be subject to notice and 13222 of August 17, 2001, 3 CFR, 2001 publication is unnecessary. Moreover, the opportunity for public comment because, as noted above, the criteria and Comp., p. 783 (2002), as amended by because it is unnecessary. In process for authorizing and Executive Order 13637 of March 8, determining whether to grant VEU administering VEUs were developed 2013, 78 FR 16129 (March 13, 2013) and designations, a committee of U.S. with public comments, allowing as extended by the Notice of August 4, Government agencies evaluates additional public comment on this 2016, 81 FR 52587 (August 8, 2016), has information about and commitments amendment to individual VEU continued the Export Administration made by candidate companies, the Regulations in effect under the nature and terms of which are set forth authorizations, which was determined International Emergency Economic in 15 CFR part 748, supplement No. 8. according to those criteria, is Powers Act. BIS continues to carry out The criteria for evaluation by the unnecessary. the provisions of the Export committee are set forth in 15 CFR Section 553(d) of the APA generally Administration Act, as appropriate and 748.15(a)(2). The information, provides that rules may not take effect to the extent permitted by law, pursuant commitments, and criteria for this earlier than thirty (30) days after they to Executive Order 13222 as amended extensive review were all established are published in the Federal Register. by Executive Order 13637. through the notice of proposed However, BIS finds good cause to waive Rulemaking Requirements rulemaking and public comment the 30-day delay in effectiveness for this process (71 FR 38313 (July 6, 2006) rule pursuant to 5 U.S.C. 553(d)(3) 1. Executive Orders 13563 and 12866 (proposed rule), and 72 FR 33646 (June because the delay would be contrary to direct agencies to assess all costs and 19, 2007) (final rule)). Given the the public interest. BIS is simply benefits of available regulatory similarities between the authorizations amending the authorization of an alternatives and, if regulation is provided under the VEU program and existing VEU to update the address of necessary, to select regulatory export licenses (as discussed further the eligible destination (facility). BIS approaches that maximize net benefits below), the publication of this amends the EAR in this rule consistent (including potential economic, information does not establish new with established objectives and environmental, public health and safety policy. In publishing this final rule, BIS parameters administered and enforced effects, distributive impacts, and amends the authorization for an existing by the responsible designated equity). Executive Order 13563 eligible VEU to update the address of departmental representatives to the End- emphasizes the importance of the eligible destination (facility). This User Review Committee. Delaying this quantifying both costs and benefits, change has been made within the action’s effectiveness would likely cause reducing costs, harmonizing rules, and established regulatory framework of the confusion regarding which items are promoting flexibility. This rule has been VEU program. Further, this rule does authorized by the U.S. Government to determined to be not significant for not abridge the rights of the public or be shipped to which eligible destination purposes of Executive Order 12866. eliminate the public’s option to export (facility), which would stifle the 2. This rule involves collections under any of the forms of authorization purpose of the VEU Program. previously approved by the Office of set forth in the EAR. Accordingly, it is contrary to the public Management and Budget (OMB) under Publication of this rule in other than interest to delay this rule’s effectiveness. Control Number 0694–0088, ‘‘Multi- final form is unnecessary because the Purpose Application,’’ which carries a authorizations granted in the rule are No other law requires that a notice of burden hour estimate of 43.8 minutes to consistent with the authorizations proposed rulemaking and an prepare and submit form BIS–748; and granted to exporters for individual opportunity for public comment be for recordkeeping, reporting and review licenses (and amendments or revisions given for this final rule. Because a requirements in connection with thereof), which do not undergo public notice of proposed rulemaking and an Authorization VEU, which carries an review. In addition, as with license opportunity for public comment are not estimated burden of 30 minutes per applications, VEU authorization required under the APA or by any other submission. This rule is expected to applications contain confidential law, the analytical requirements of the result in a decrease in license business information, which is Regulatory Flexibility Act (5 U.S.C. 601 applications submitted to BIS. Total necessary for the extensive review et seq.) are not applicable. As a result, burden hours associated with the conducted by the U.S. Government in no final regulatory flexibility analysis is Paperwork Reduction Act of 1995 (44 assessing such applications. This required and none has been prepared. U.S.C. 3501 et seq.) (PRA) and OMB information is extensively reviewed List of Subjects in 15 CFR Part 748 Control Number 0694–0088 are not according to the criteria for VEU expected to increase significantly as a authorizations, as set out in 15 CFR Administrative practice and result of this rule. Notwithstanding any 748.15(a)(2). Additionally, just as procedure, Exports, Reporting and other provisions of law, no person is license applications are reviewed recordkeeping requirements.

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Accordingly, part 748 of the EAR (15 PART 748—[AMENDED] 3 CFR, 2001 Comp., p. 783; Notice of August CFR parts 730–774) is amended as 4, 2016, 81 FR 52587 (August 8, 2016). follows: ■ 1. The authority citation for part 748 ■ 2. Amend supplement No. 7 to part continues to read as follows: 748 by revising the entry for ‘‘Boeing Authority: 50 U.S.C. 4601 et seq.; 50 U.S.C. Tianjin Composites Co. Ltd.’’ in ‘‘China 1701 et seq.; E.O. 13026, 61 FR 58767, 3 CFR, (People’s Republic of)’’ to read as 1996 Comp., p. 228; E.O. 13222, 66 FR 44025, follows:

SUPPLEMENT NO. 7 TO PART 748—AUTHORIZATION VALIDATED END-USER (VEU): LIST OF VALIDATED END-USERS, RESPECTIVE ITEMS ELIGIBLE FOR EXPORT, REEXPORT AND TRANSFER, AND ELIGIBLE DESTINATIONS

Validated Eligible items Federal Register Country end-user (by ECCN) Eligible destination citation

Nothing in this Supplement shall be deemed to supersede other provisions in the EAR, including but not limited to § 748.15(c).

******* Boeing 1B001.f, 1D001 (limited to ‘‘software’’ specially designed Boeing Tianjin Composites 72 FR 59164, 10/19/ Tianjin or modified for the ‘‘use’’ of equipment controlled by Co. Ltd., 4566 Hebei 07. Composites 1B001.f), 2B001.b.2 (limited to machine tools with ac- Road, Marine Hi-Tech 74 FR 19382, 4/29/ Co. Ltd. curacies no better than (i.e., not less than) 13 mi- Development Area, 09. crons), 2D001 (limited to ‘‘software,’’ other than that Tanggu District, Tianjin, 77 FR 10953, 2/24/ controlled by 2D002, specially designed or modified China 300451. 12. for the ‘‘use’’ of equipment controlled by 2B001.b.2), 77 FR 40258, 7/9/12. and 2D002 (limited to ‘‘software’’ for electronic de- 81 FR [INSERT vices, even when residing in an electronic device or PAGE NUMBER], system, enabling such devices or systems to function September 6, 2016. as a ‘‘numerical control’’ unit, capable of coordinating simultaneously more than 4 axes for ‘‘contouring con- trol’’ controlled by 2B001.b.2).

*******

Dated: August 30, 2016. antiseptic washes) are not generally Hampshire Ave., Bldg. 22, Rm. 5418, Kevin J. Wolf, recognized as safe and effective (GRAS/ Silver Spring, MD 20993–0002, 240– Assistant Secretary for Export GRAE) and are misbranded. FDA is 402–0272. Administration. issuing this final rule after considering SUPPLEMENTARY INFORMATION: the recommendations of the [FR Doc. 2016–21333 Filed 9–2–16; 8:45 am] Table of Contents BILLING CODE 3510–33–P Nonprescription Drugs Advisory Committee (NDAC); public comments I. Introduction on the Agency’s notices of proposed A. Terminology Used in the OTC Drug rulemaking; and all data and Review Regulations DEPARTMENT OF HEALTH AND B. Topical Antiseptics HUMAN SERVICES information on OTC consumer antiseptic wash products that have C. This Final Rule Covers Only Consumer Antiseptic Washes Food and Drug Administration come to the Agency’s attention. This II. Background final rule amends the 1994 tentative A. Significant Rulemakings Relevant to 21 CFR Part 310 final monograph (TFM) for OTC This Final Rule antiseptic drug products that published B. Public Meetings Relevant to This Final [Docket No. FDA–1975–N–0012; Formerly in the Federal Register of June 17, 1994 Rule Part of Docket No. 1975N–0183H] (the 1994 TFM). The final rule is part of C. Scope of This Final Rule RIN 0910–AF69 the ongoing review of OTC drug D. Eligibility for the OTC Drug Review products conducted by FDA. III. Comments on the Proposed Rule and FDA Safety and Effectiveness of Consumer Response DATES: This rule is effective September A. Introduction Antiseptics; Topical Antimicrobial 6, 2017. B. Description of General Comments and Drug Products for Over-the-Counter ADDRESSES: For access to the docket to FDA Response Human Use read background documents or C. Comments on Effectiveness and FDA comments received, go to http:// Response AGENCY: Food and Drug Administration, D. Comments on Safety and FDA Response HHS. www.regulations.gov and insert the E. Comments on Individual Active ACTION: Final rule. docket number found in brackets in the Ingredients and FDA Response heading of this final rule into the F. Comments on the Preliminary SUMMARY: The Food and Drug ‘‘Search’’ box and follow the prompts, Regulatory Impact Analysis and FDA Administration (FDA, we, or the and/or go to the Division of Dockets Response Agency) is issuing this final rule Management, 5630 Fishers Lane, Rm. IV. Ingredients Not Generally Recognized as establishing that certain active 1061, Rockville, MD 20852. Safe and Effective V. Effective Date ingredients used in over-the-counter FOR FURTHER INFORMATION CONTACT: VI. Summary of Regulatory Impact Analysis (OTC) consumer antiseptic products Pranvera Ikonomi, Center for Drug A. Introduction intended for use with water (referred to Evaluation and Research, Food and B. Summary of Costs and Benefits throughout this document as consumer Drug Administration, 10903 New VII. Paperwork Reduction Act of 1995

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