Unknown. Final rule

10,444 words·~47 min read·/register/2018/10/17/2018-22694·

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--- schema: federal-register doc_type: fedreg source_file: FR-2018-10-17.xml --- 83 201 Wednesday, October 17, 2018 Contents Agriculture Agriculture Department See Animal and Plant Health Inspection Service NOTICES Agency Information Collection Activities; Proposals, Submissions, and Approvals, 52376-52377 2018-22521 Requests for Nominations: Advisory Committee on Beginning Farmers and Ranchers, 52376 2018-22146 Advisory Committee on Minority Farmers and Ranchers, 52377 2018-22149 Animal Animal and Plant Health Inspection Service NOTICES Determinations:

Texas A and M AgriLife Research; Nonregulated Status of Cotton Genetically Engineered for Ultra-low Gossypol Levels in Cottonseed, 52377-52378 2018-22545 Antitrust Division Antitrust Division NOTICES Changes under the National Cooperative Research and Production Act: UHD Alliance, Inc., 52557-52558 2018-22543 Proposed Final Judgment and Competitive Impact Statement: United States v. CVS Health Corp. and Aetna, Inc., 52558-52569 2018-22665 United States v. United Technologies Corp., et al., 52542-52557 2018-22555 Centers Disease Centers for Disease Control and Prevention NOTICES Charter Renewals:

Breast and Cervical Cancer Early Detection and Control Advisory Committee, 52455 2018-22561 Disease, Disability, and Injury Prevention and Control Special Emphasis Panel, 52455 2018-22616 Infectious Diseases and Circumstances Relevant to Notification Requirements: Definition of Emergency Response Employee, 52454-52455 2018-22522 Centers Medicare Centers for Medicare & Medicaid Services NOTICES Medicaid Program: CY 2019 Inpatient Hospital Deductible and Hospital and Extended Care Services Coinsurance Amounts, 52459-52462 2018-22526 Medicare and Medicaid Program:

Application from the Accreditation Association for Hospitals/Health Systems—Healthcare Facilities Accreditation Program for Approval of its Hospital Accreditation Program, 52458-52459 2018-22546 Medicare Program: CY 2019 Part A Premiums for the Uninsured Aged and for Certain Disabled Individuals Who Have Exhausted Other Entitlement, 52455-52458 2018-22529 Medicare Part B Monthly Actuarial Rates, Premium Rates, and Annual Deductible Beginning January 1, 2019, 52462-52471 2018-22530 Civil Rights Civil Rights Commission NOTICES Meetings:

Colorado Advisory Committee, 52379 2018-22614 Connecticut Advisory Committee, 52378-52379 2018-22615 Coast Guard Coast Guard RULES Drawbridge Operations: Delaware River, Pennsauken Township, NJ, 52319-52320 2018-22692 Safety Zones: Blue Angels Air Show; St. Johns River, Jacksonville, FL, 52320-52322 2018-22519 PROPOSED RULES Great Lakes Pilotage Rates—2019 Annual Review and Revisions to Methodology, 52355-52375 2018-22513 Special Local Regulations: Marine Events in Coast Guard Sector Detroit Captain of the Port Zone, 52333-52336 2018-22517 NOTICES Agency Information Collection Activities;

Proposals, Submissions, and Approvals: OMB Control Number: 1625-0035; Correction, 52498 2018-22552 OMB Control Number: 1625-0069; Correction, 52498 2018-22553 Commerce Commerce Department See Economic Analysis Bureau See Foreign-Trade Zones Board See International Trade Administration See National Oceanic and Atmospheric Administration NOTICES Cross-Agency Priority Goal: Leveraging Data as a Strategic Asset: Phase 2, 52379-52381 2018-22490 Committee Implementation Committee for the Implementation of Textile Agreements NOTICES Commercial Availability Request under U.S.-Korea Free Trade Agreement, 52418-52419 2018-22610 Consumer Product Consumer Product Safety Commission NOTICES Meetings;

Sunshine Act, 52419 2018-22731 Copyright Office Copyright Office, Library of Congress PROPOSED RULES Registration Modernization, 52336-52345 2018-22486 Corporation Corporation for National and Community Service NOTICES Agency Information Collection Activities; Proposals, Submissions, and Approvals: Application Package for Employers of National Service Enrollment Form and Employers of National Service Annual Survey, 52419-52420 2018-22636 Defense Department Defense Department RULES Privacy Act;

Implementation, 52317-52319 2018-22507 NOTICES Privacy Act; Systems of Records, 52420-52426 2018-22508 Economic Analysis Bureau Economic Analysis Bureau NOTICES Meetings: Bureau of Economic Analysis Advisory Committee, 52381-52382 2018-22547 Education Department Education Department NOTICES Agency Information Collection Activities; Proposals, Submissions, and Approvals: Recent Graduates Employment and Earnings Survey Standards and Survey Form, 52426-52427 2018-22520 Application to Pilot:

Federal Student Aid's Next Generation Financial Services Environment—Payment Vehicle Account Program, 52427-52436 2018-22646 Energy Department Energy Department See Federal Energy Regulatory Commission NOTICES Procedures for Conducting Electric Transmission Congestion Studies, 52436 2018-22648 Environmental Protection Environmental Protection Agency RULES Fees for Administration of Toxic Substances Control Act, 52694-52724 2018-22252 NOTICES Requests for Nominations: Hazardous Waste Electronic Manifest System Advisory Board, 52446-52448 2018-22651 Requests to Voluntarily Cancel Certain Pesticide Registrations, 52448-52450 2018-22657 Requests to Voluntarily Cancel Certain Pesticide Registrations and Amend Registrations to Terminate Certain Uses, 52444-52446 2018-22658 Federal Aviation Federal Aviation Administration RULES Airworthiness Directives:

The Boeing Company Airplanes, 52305-52313 R1--2018--21460 NOTICES Petition for Exemption; Summary: Boeing Co., 52610 2018-22662 Federal Communications Federal Communications Commission NOTICES Agency Information Collection Activities; Proposals, Submissions, and Approvals, 52450-52451 2018-22527 Termination of Dormant Proceedings, 52450 2018-22510 Federal Energy Federal Energy Regulatory Commission NOTICES Agency Information Collection Activities; Proposals, Submissions, and Approvals, 52442-52443 2018-22611 Combined Filings, 52438-52439, 52441 2018-22624 2018-22625 Complaints:

Southwest Airlines Co., United Aviation Fuels Corp. v. Colonial Pipeline Co., 52439 2018-22628 Effectiveness of Exempt Wholesale Generator Status: Bluebell Solar, LLC; Casa Mesa Wind, LLC; Titan Solar, LLC; et al., 52439 2018-22626 Environmental Assessments; Availability, etc.: Cheyenne Connector, LLC, Rockies Express Pipeline, LLC; Cheyenne Connector Pipeline, Cheyenne Hub Enhancement Projects, 52437-52438 2018-22608 Filings: Virginia Electric and Power Co., 52439 2018-22607 Hydroelectric Applications:

New England Hydropower Co., LLC, 52436-52437, 52440 2018-22606 2018-22609 Initial Market-Based Rate Filings Including Requests for Blanket Section 204 Authorizations: Athens Energy, LLC, 52440-52441 2018-22627 License Transfers: Andrew Peklo, III; Pomperaug Hydro, LLC, 52438 2018-22612 Federal Housing Finance Agency Federal Housing Finance Agency NOTICES Agency Information Collection Activities; Proposals, Submissions, and Approvals, 52451-52452 2018-22667 Federal Railroad Federal Railroad Administration NOTICES Compliance Waivers;

Petitions, 52610-52611 2018-22562 2018-22563 Federal Reserve Federal Reserve System NOTICES Agency Information Collection Activities; Proposals, Submissions, and Approvals, 52452-52453 2018-22551 Federal Transit Federal Transit Administration NOTICES Response to Comments on National Transit Database Reporting Changes and Clarifications, 52611-52614 2018-22528 Food and Drug Food and Drug Administration RULES Medical Devices: Immunology and Microbiology Devices; Classification of Herpes Virus Nucleic Acid-Based Cutaneous and Mucocutaneous Lesion Panel, 52313-52315 2018-22694 Neurological Devices;

Classification of External Upper Limb Tremor Stimulator, 52315-52316 2018-22695 NOTICES Agency Information Collection Activities; Proposals, Submissions, and Approvals: Disease Awareness and Prescription Drug Promotion on Television, 52472-52477 2018-22567 Experimental Study of Accelerated Approval Disclosure, 52478-52481 2018-22570 Guidance for Industry on Establishing that Tobacco Product was Commercially Marketed in United States as of February 15, 2007, 52488-52490 2018-22578 Physician Interpretation of Information about Prescription Drugs in Scientific Publications Versus Promotional Pieces, 52490-52494 2018-22569 Debarment Orders:

Isachi Gil, 52487-52488 2018-22581 Determinations of Regulatory Review Periods for Purposes of Patent Extensions: BRINEURA, 52483-52484 2018-22559 DUPIXENT, 52481-52483 2018-22566 TREMFYA, 52471-52472 2018-22571 Guidance: Presenting Quantitative Efficacy and Risk Information in Direct-to-Consumer Promotional Labeling and Advertisements, 52484-52487 2018-22568 Oncology Center of Excellence: Pediatric Oncology Program, 52477-52478 2018-22565 Foreign Trade Foreign-Trade Zones Board NOTICES Production Activities:

Eastman Kodak Co., Foreign-Trade Zone 106, Oklahoma City, OK, 52382 2018-22583 Mayfield Consumer Products; Foreign-Trade Zone 294; Western Kentucky, 52383 2018-22584 Reorganizations and Expansions under Alternative Site Frameworks: Foreign-Trade Zone 142, Salem/Millville, NJ, 52382 2018-22603 Subzone Applications: Mayfield Consumer Products; Foreign-Trade Zone 294; Western Kentucky, 52382-52383 2018-22582 General Services General Services Administration NOTICES Agency Information Collection Activities;

Proposals, Submissions, and Approvals: Mobile Now Act, 52453 2018-22650 Health and Human Health and Human Services Department See Centers for Disease Control and Prevention See Centers for Medicare & Medicaid Services See Food and Drug Administration See National Institutes of Health Homeland Homeland Security Department See Coast Guard See U.S. Customs and Border Protection NOTICES Agency Information Collection Activities; Proposals, Submissions, and Approvals: Nationwide Cyber Security Review Assessment, 52499-52500 2018-22548 Telecommunications Service Priority System, 52500-52501 2018-22549 Housing Housing and Urban Development Department NOTICES Agency Information Collection Activities;

Proposals, Submissions, and Approvals: Maintenance Wage Rate Recommendation, Maintenance Wage Rate Survey and Maintenance Wage Survey—Summary Sheet, 52503 2018-22645 Requests for Nominations: Manufactured Housing Consensus Committee, 52501-52503 2018-22644 Institute of Museum and Library Services Institute of Museum and Library Services NOTICES Meetings: National Museum and Library Services Board, 52571 2018-22618 Interior Interior Department See Land Management Bureau See National Park Service NOTICES National Environmental Policy Act Implementing Procedures for Bureau of Reclamation, 52503-52505 2018-22630 Internal Revenue Internal Revenue Service PROPOSED RULES De Minimis Error Safe Harbor Exceptions to Penalties for Failure to File Correct Information Returns or Furnish Correct Payee Statements, 52726-52749 2018-22393 International Trade Adm International Trade Administration NOTICES Antidumping or Countervailing Duty Investigations, Orders, or Reviews:

Certain Uncoated Paper from Indonesia, 52383-52384 2018-22633 Tapered Roller Bearings and Parts Thereof, Finished and Unfinished, from the People's Republic of China, 52384-52385 2018-22579 Initiation of Less-Than-Fair-Value Investigations: Mattresses from the People's Republic of China, 52386-52391 2018-22577 July 2018 Approved Trade Missions, 52391-52394 2018-22097 Requests for Nominations: Corporation for Travel Promotion Board of Directors, 52385-52386 2018-22580 Justice Department Justice Department See Antitrust Division Labor Department Labor Department NOTICES Agency Information Collection Activities;

Proposals, Submissions, and Approvals: National Guard Youth ChalleNGe Job ChalleNGe Evaluation, 52570 2018-22556 Land Land Management Bureau NOTICES Competitive Coal Leases: ALES-55199, Alabama; Correction, 52505 2018-22666 Library Library of Congress See Copyright Office, Library of Congress NASA National Aeronautics and Space Administration NOTICES Records of Decisions: NASA Groundwater Cleanup Activities at Santa Susana Field Laboratory, 52570-52571 2018-22660 National Endowment for the Humanities National Endowment for the Humanities NOTICES Meetings:

Humanities Panel, 52571-52572 2018-22544 National Foundation National Foundation on the Arts and the Humanities See Institute of Museum and Library Services See National Endowment for the Humanities National Institute National Institutes of Health NOTICES Meetings: Center for Scientific Review, 52494-52497 2018-22623 2018-22632 National Center for Advancing Translational Sciences, 52495 2018-22634 National Center for Complementary and Integrative Health, 52495 2018-22629 National Heart, Lung, and Blood Institute, 52496-52497 2018-22620 2018-22621 National Institute of Allergy and Infectious Diseases, 52495 2018-22622 National Institute of Environmental Health Sciences, 52497-52498 2018-22631 National Institute on Aging, 52497 2018-22619 National Oceanic National Oceanic and Atmospheric Administration RULES Authorization of Revised Reporting Requirements Due to Catastrophic Conditions for Federal Seafood Dealers and Individual Fishing Quota Dealers in Portions of Florida, 52330-52332 2018-22647 Fisheries of the Exclusive Economic Zone off Alaska:

Pollock in Statistical Area 610 in Gulf of Alaska, 52332 2018-22642 NOTICES Agency Information Collection Activities; Proposals, Submissions, and Approvals, 52417 2018-22573 Agency Information Collection Activities; Proposals, Submissions, and Approvals: Estimating Economic Burden of Vibrio parahaemolyticus in Washington State Aquaculture, 52416-52417 2018-22574 Requests for Nominations: NOAA Science Advisory Board, 52417-52418 2018-22637 Takes of Marine Mammals Incidental to Specified Activities:

In-Water Demolition and Construction Activities Associated with Harbor Improvement Project in Statter Harbor, AK, 52394-52416 2018-22604 National Park National Park Service NOTICES Inventory Completions: Arizona State Museum, University of Arizona, Tucson, AZ, 52508-52520, 52538-52539 2018-22597 2018-22600 Arizona State Museum, University of Arizona, Tucson, AZ; Correction, 52541-52542 2018-22594 Arizona State Parks and Trails, Phoenix, AZ, and Arizona State Museum, University of Arizona, Tucson, AZ, 52539-52541 2018-22596 California Department of Parks and Recreation, Sacramento, CA, 52521-52522, 52526-52527 2018-22590 2018-22591 Carter County Museum, Ekalaka, MT, 52537 2018-22589 Department of Defense, Army Corps of Engineers, Nashville District, Nashville, TN;

Correction, 52536 2018-22586 History Colorado, formerly Colorado Historical Society, Denver, CO, 52505-52507 2018-22593 Princeton University, Princeton, NJ, 52535-52536 2018-22602 Sam Noble Oklahoma Museum of Natural History, Norman, OK, 52522-52525 2018-22592 Sternberg Museum of Natural History, Hays, KS, 52527-52528 2018-22587 University of California, Davis, Davis, CA, and U.S. Bureau of Reclamation, Mid-Pacific Region, Sacramento, CA, 52530-52531 2018-22601 University of Oregon Museum of Natural and Cultural History, Eugene, OR, 52525-52526 2018-22585 National Register of Historic Places:

Pending Nominations and Related Actions, 52507-52508, 52520-52521 2018-22524 2018-22525 Repatriations of Cultural Items: Arizona State Museum, University of Arizona, Tucson, AZ, 52532-52535 2018-22598 Arizona State Museum, University of Arizona, Tucson, AZ; Correction, 52528 2018-22595 Arizona State Parks and Trails, Phoenix, AZ, and Arizona State Museum, University of Arizona, Tucson, AZ, 52529-52530 2018-22599 Sternberg Museum of Natural History, Hays, KS, 52537-52538 2018-22588 Neighborhood Neighborhood Reinvestment Corporation NOTICES Meetings;

Sunshine Act, 52572-52573 2018-22741 Nuclear Regulatory Nuclear Regulatory Commission NOTICES Exemptions: NorthStar Group Services, Inc.; Vermont Yankee Nuclear Power Station, 52573-52575 2018-22649 Guidance: Environmental Dosimetry-Performance Specifications, Testing, and Data Analysis, 52576-52577 2018-22550 Postal Regulatory Postal Regulatory Commission NOTICES Competitive Price Adjustment, 52578-52579 2018-22542 Mail Classification Schedule, 52577-52578 2018-22523 2018-22663 Postal Service Postal Service RULES Domestic Competitive Products Pricing and Mailing Standards Changes, 52326-52330 2018-22474 International Competitive Services Product and Price Changes, 52323-52325 2018-22472 PROPOSED RULES International Mailing Services:

Product and Price Changes—CPI, 52351-52353 2018-22473 New Mailing Standards for Domestic Mailing Services Products, 52353-52354 2018-22475 NOTICES Change in Rates and Classes of General Applicability for Competitive Products, 52618-52692 2018-22410 Securities Securities and Exchange Commission NOTICES Applications: Destra International and Event-Driven Credit Fund and Destra Capital Advisors, LLC, 52602-52605 2018-22541 Self-Regulatory Organizations; Proposed Rule Changes: Cboe BYX Exchange, Inc., 52595-52598 2018-22534 Cboe BZX Exchange, Inc., 52588-52593 2018-22533 2018-22535 Cboe EDGA Exchange, Inc., 52598-52602 2018-22536 Cboe EDGX Exchange, Inc., 52605-52608 2018-22537 LCH SA, 52581-52586 2018-22540 Nasdaq ISE, LLC, 52593-52595 2018-22538 New York Stock Exchange, LLC, 52579-52581 2018-22539 NYSE American, LLC, 52586-52588 2018-22532 Small Business Small Business Administration NOTICES Disaster Declarations:

New York, 52609-52610 2018-22638 Pennsylvania, 52609 2018-22640 Enterprise Learning Agenda, 52608 2018-22643 Major Disasters: Connecticut, 52608-52609 2018-22639 State Department State Department NOTICES Meetings: Cultural Property Advisory Committee, 52610 2018-22641 Transportation Department Transportation Department See Federal Aviation Administration See Federal Railroad Administration See Federal Transit Administration Treasury Treasury Department See Internal Revenue Service NOTICES Agency Information Collection Activities;

Proposals, Submissions, and Approvals, 52614-52616 2018-22554 Customs U.S. Customs and Border Protection NOTICES Agency Information Collection Activities; Proposals, Submissions, and Approvals: Application for Extension of Bond for Temporary Importation, 52498-52499 2018-22512 Veteran Affairs Veterans Affairs Department RULES Net Worth, Asset Transfers, and Income Exclusions for Needs-Based Benefits, 52322-52323 2018-22564 PROPOSED RULES Adopting Standards for Laboratory Requirements, 52345-52350 2018-22452 NOTICES Meetings:

National Research Advisory Council, 52616 2018-22664 Separate Parts In This Issue Part II Postal Service, 52618-52692 2018-22410 Part III Environmental Protection Agency, 52694-52724 2018-22252 Part IV Treasury Department, Internal Revenue Service, 52726-52749 2018-22393 Reader Aids Consult the Reader Aids section at the end of this issue for phone numbers, online resources, finding aids, and notice of recently enacted public laws. To subscribe to the Federal Register Table of Contents electronic mailing list, go to https://public.govdelivery.com/accounts/USGPOOFR/subscriber/new, enter your e-mail address, then follow the instructions to join, leave, or manage your subscription. 83 201 Wednesday, October 17, 2018 Rules and Regulations DEPARTMENT OF TRANSPORTATION Federal Aviation Administration 14 CFR Part 39 [Docket No.

FAA-2017-0127; Product Identifier 2016-NM-161-AD; Amendment 39-19447; AD 2018-20-13] RIN 2120-AA64 Airworthiness Directives; The Boeing Company Airplanes AGENCY: Federal Aviation Administration (FAA), DOT. ACTION: Final rule. SUMMARY: We are adopting a new airworthiness directive

(AD)for all The Boeing Company Model 737 airplanes, excluding Model 737-100, -200, -200C, -300, -400, and -500 series airplanes; all Model 757-200, -200PF, -200CB, and -300 series airplanes; and all Model 767-200, -300, -300F, and -400ER series airplanes. This AD was prompted by reports of latently failed motor-operated valve

(MOV)actuators of the fuel shutoff valves. This AD requires replacing certain MOV actuators of the fuel shutoff valves for the left and right engines (on certain airplanes) and of the auxiliary power unit

(APU)fuel shutoff valve (on Model 757 and Model 767 airplanes); and revising the maintenance or inspection program to incorporate certain airworthiness limitations (AWLs). We are issuing this AD to address the unsafe condition on these products. DATES: This AD is effective November 15, 2018. The Director of the Federal Register approved the incorporation by reference of certain publications listed in this AD as of November 15, 2018. ADDRESSES: For service information identified in this final rule, contact Boeing Commercial Airplanes, Attention: Contractual & Data Services (C&DS), 2600 Westminster Blvd., MC 110-SK57, Seal Beach, CA 90740-5600; telephone: 562-797-1717; internet: *https://www.myboeingfleet.com.* You may view this service information at the FAA, Transport Standards Branch, 2200 South 216th St., Des Moines, WA. For information on the availability of this material at the FAA, call 206-231-3195. It is also available on the internet at *http://www.regulations.gov* by searching for and locating Docket No. FAA-2017-0127. Examining the AD Docket You may examine the AD docket on the internet at *http://www.regulations.gov* by searching for and locating Docket No. FAA-2017-0127; or in person at Docket Operations between 9 a.m. and 5 p.m., Monday through Friday, except Federal holidays. The AD docket contains this final rule, the regulatory evaluation, any comments received, and other information. The address for Docket Operations (phone: 800-647-5527) is Docket Operations, U.S. Department of Transportation, Docket Operations, M-30, West Building Ground Floor, Room W12-140, 1200 New Jersey Avenue SE, Washington, DC 20590. FOR FURTHER INFORMATION CONTACT: Tak Kobayashi, Aerospace Engineer, Propulsion Section, FAA, Seattle ACO Branch, 2200 South 216th St., Des Moines, WA 98198; phone and fax: 206-231-3553; email: *Takahisa.Kobayashi@faa.gov.* SUPPLEMENTARY INFORMATION: Discussion We issued a notice of proposed rulemaking

(NPRM)to amend 14 CFR part 39 by adding an AD that would apply to all The Boeing Company Model 737-600, -700, -700C, -800, -900, and -900ER series airplanes; Model 757 airplanes; and Model 767 airplanes. The NPRM published in the **Federal Register** on March 9, 2017 (82 FR 13073). The NPRM was prompted by reports of latently failed MOV actuators of the fuel shutoff valves. The NPRM proposed to require replacing certain MOV actuators of the fuel shutoff valves for the left and right engines (on all airplanes) and of the APU fuel shutoff valve (on Model 757 and Model 767 airplanes); and revising the maintenance or inspection program, as applicable, to incorporate certain AWLs. We subsequently issued a supplemental NPRM (SNPRM) to amend 14 CFR part 39 by adding an AD that would apply to all Model 737 airplanes, excluding Model 737-100, -200, -200C, -300, -400, and -500 series airplanes; and all Model 757 and 767 airplanes. The SNPRM published in the **Federal Register** on April 3, 2018 (83 FR 14207). The SNPRM proposed to add Model 737-8 airplanes and future Model 737 airplanes to the applicability. We are issuing this AD to address a latent failure of the actuator for the engine or APU fuel shutoff valves, which could result in the inability to shut off fuel to the engine or the APU, and, in case of certain engine or APU fires, could result in structural failure. Republication Editorial Note: Rule document 2018-21460 was originally published on pages 51304 through 51313 in the issue of Thursday, October 11, 2018. In that publication, on page 51307, in the second column, in (c)(1), “Estimated -200” should read “-200”. The corrected document is published here in its entirety. Comments We gave the public the opportunity to participate in developing this final rule. The following presents the comments received on the SNPRM and the FAA's response to each comment. Request To Exclude Model 737-8 and Future Model 737 Boeing requested that we revise the proposed AD (in the SNPRM) to exclude Model 737-8 airplanes and future Model 737 airplanes, because MOV actuator part number MA30A1017 (Boeing P/N S343T003-76) is the only certified MOV actuator for use on any future Model 737 airplanes as documented in the drawings and Illustrated Parts Catalog (IPC). The commenter stated that using airworthiness limitations to prohibit the use of parts with AD restrictions on one minor model series (Model 737 next generation

(NG)airplanes) from being used on a different minor model series (Model 737-8 and future Model 737 airplanes) that does not allow the use of the restricted parts is unnecessary and implies that certified configurations and ADs can be overridden via an Advisory Circular

(AC)or other means. We disagree with the commenter's request. The MOV actuator currently allowed on Model 737-8 and 737-9 airplanes, part number MA30A1017 (Boeing P/N S343T003-76), is the only part number certificated on those models, as documented in the manufacturer's drawings. However, manufacturer's proprietary drawings are not readily available to all affected operators, and there is no prohibition against installing MOV actuator part numbers that were determined unsafe in this AD. We have been informed by operators that the practice of rotating physically interchangeable parts among airplanes is widespread, and even a key part of their operations. In the absence of an AD or AWL that restricts the installation of the affected parts, we cannot be assured that the unsafe condition will not be introduced to Model 737-8, 737-9, and future 737 airplanes. In addition, ACs are advisory in nature and do not include mandatory actions. Therefore, ACs do not take precedence over ADs. We have not changed this AD regarding this issue. Request To Remove Requirement To Revise Maintenance Program Boeing requested that we remove paragraph

(j)of the proposed AD and revise FAA AC 120-77 or other applicable advisory material to preclude installation of equipment that both Boeing and the FAA have determined cause a potential safety issue, against certified configurations. Boeing suggested that listing parts that are not approved for use on a given model sets a precedent that can become unmanageable, and that identifying parts that are acceptable for a given airplane and installation position is a more explicit and manageable approach. Boeing added that the use of AWLs to prohibit AD-driven part installations is unnecessary and implies that certified configurations and ADs can be overridden via an AC or other means. We disagree with the commenter's request. The FAA is currently considering revising AC 120-77 to help prevent the rotation of parts as a minor alteration. However, ACs are advisory in nature and do not include mandatory actions. Therefore, ACs cannot prohibit the installation of unsafe equipment, and they do not take precedence over ADs. In addition, the practice of rotating parts is widespread, and revising the AC will not improve the situation in a timely manner. Certain MOV actuator part numbers have been identified to be unsafe for installation at certain locations. Since those part numbers continue to be available and acceptable for installation at certain other locations, we consider the use of AWLs to prohibit specific parts installation to be a reasonable way to address the safety concern in a timely manner. We have not changed this AD regarding this issue. Request To Clarify Affected Part Numbers FedEx requested that we revise paragraphs (h)(2) and (h)(3) of the proposed AD (in the SNPRM) to state that no replacement is necessary if the MOV actuator part number is one of the following alternative part numbers: AV-31-1 (Boeing P/N S343T003-111), MA11A1265 (Boeing P/N S343T003-14), or MA11A1265-1 (Boeing P/N S343T003-41). FedEx stated that the service information specified in paragraphs (h)(2) and (h)(3) of the proposed AD (in the SNPRM) explicitly state that those alternative MOV actuator part numbers are acceptable substitutes for P/N MA30A1017 (Boeing P/N S343T003-76). We disagree with the commenter's request. However, we agree to clarify the requirements of paragraphs (h)(2) and (h)(3) of this AD. Paragraphs (h)(2) and (h)(3) of this AD require replacement of MOV actuator P/N MA20A2027 (Boeing P/N S343T003-56) and P/N MA30A1001 (Boeing P/N S343T003-66) with an acceptable MOV actuator part number. Those paragraphs do not state or imply that MOV actuator P/N AV-31-1 (Boeing P/N S343T003-111), P/N MA11A1265 (Boeing P/N S343T003-14), or P/N MA11A1265-1 (Boeing P/N S343T003-41) must be replaced. Therefore, we consider that adding the proposed statement is unnecessary. We have not changed this AD regarding this issue. Request To Add a Terminating Action Provision FedEx requested that we revise paragraphs (i)(2) and (i)(3) of the proposed AD (in the SNPRM) to state that the actuator installation would terminate the daily functional checks required by AWLs 28-AWL-ENG and 28-AWL-APU. The commenter added that installation of MOV actuator part number MA30A1017 (Boeing P/N S343T003-76) or an acceptable alternative part number should substantially increase the safety value. We disagree with the commenter's request. We have determined that accomplishing the applicable maintenance or inspection program revisions specified in paragraph

(j)of this AD are the appropriate terminating actions. As discussed previously in the preamble of the SNPRM, we included the conditions (accomplishing the applicable maintenance or inspection program revisions) that would terminate the requirements of AD 2015-21-10, Amendment 39-18303 (80 FR 65130, October 26, 2015); AD 2015-19-04, Amendment 39-18267 (80 FR 55505, September 16, 2015); and AD 2015-21-09, Amendment 39-18302 (80 FR 65121, October 26, 2015). Those ADs require incorporation of the AWLs that require repetitive inspections of specific MOV actuator part numbers installed at specific locations. The requirements of those ADs may be terminated if the applicable conditions specified in paragraph

(m)of this AD are met. We have not changed this AD regarding this issue. Request To Refer to Latest Service Information Southwest Airlines requested that we refer to the latest revisions of the airworthiness limitations documents. We agree with the commenter's request and have revised this AD to refer to the current airworthiness limitations as the appropriate source of service information, and have included earlier revisions of the service information as credit in this AD. There are no changes to the required actions of this AD because the tasks that must be incorporated into the maintenance or inspection program are not changed in Boeing 737-600/700/700C/800/900/900ER Special Compliance Items/Airworthiness Limitations, D626A001-9-04, Revision June 2018; Boeing 757 Maintenance Planning Data

(MPD)Document, Section 9, Airworthiness Limitations

(AWLS)and Certification Maintenance Requirements (CMRs), D622N001-9, Revision May 2018; or Boeing 767-200/300/300F/400 Special Compliance Items/Airworthiness Limitations, D622T001-9-04, Revision March 2018; except for Task 28-AWL-23 for Model 767-200, -300, -300F, and -400ER series airplanes, which adds instructions that further describe the conditions for performing electrical bonding resistance measurements, in addition to being more descriptive regarding cap seal application. Conclusion We reviewed the relevant data, considered the comments received, and determined that air safety and the public interest require adopting this final rule with the changes described previously and minor editorial changes. We have determined that these minor changes: • Are consistent with the intent that was proposed in the SNPRM for addressing the unsafe condition; and • Do not add any additional burden upon the public than was already proposed in the SNPRM. We also determined that these changes will not increase the economic burden on any operator or increase the scope of this final rule. Related Service Information Under 1 CFR Part 51 We reviewed the following service information. • Boeing Service Bulletin 737-28-1314, dated November 17, 2014, describes procedures for installing new MOV actuators of the fuel shutoff valves for the left and right engines on Model 737-600, -700, -700C, -800, -900, and -900ER series airplanes. • Boeing 737-600/700/700C/800/900/900ER Special Compliance Items/Airworthiness Limitations, D626A001-9-04, Revision June 2018, describes AWLs for fuel tank ignition prevention on Model 737-600, -700, -700C, -800, -900, and -900ER series airplanes. • Boeing Special Attention Service Bulletin 757-28-0138, Revision 1, dated June 19, 2017, describes procedures for installing new MOV actuators of the fuel shutoff valves for the left and right engines, and of the APU fuel shutoff valve, on Model 757 airplanes. • Boeing 757 Maintenance Planning Data

(MPD)Document, Section 9, Airworthiness Limitations

(AWLs)and Certification Maintenance Requirements (CMRs), D622N001-9, Revision May 2018, describes AWLs for fuel tank ignition prevention on Model 757 airplanes. • Boeing Service Bulletin 767-28-0115, Revision 1, dated June 2, 2016, describes procedures for installing new MOV actuators of the fuel shutoff valves for the left and right engines, and of the APU fuel shutoff valve, on Model 767 airplanes. • Boeing 767-200/300/300F/400 Special Compliance Items/Airworthiness Limitations, D622T001-9-04, Revision March 2018, describes AWLs for fuel tank ignition prevention on Model 767 airplanes. This service information is reasonably available because the interested parties have access to it through their normal course of business or by the means identified in the ADDRESSES section. Costs of Compliance We estimate that this AD affects 2,557 airplanes of U.S. registry. We estimate the following costs to comply with this AD: Estimated Costs Action Labor cost Parts cost Cost per product Cost on U.S. operators Inspection and replacement Model 737 (1,440 airplanes) Up to 6 work-hours × $85 per hour = Up to $510 Up to $12,000 Up to $12,510 Up to $18,014,400. Inspection and replacement Model 757 (675 airplanes) Up to 9 work-hours × $85 per hour = Up to $765 Up to $18,000 Up to $18,765 Up to $12,666,375. Inspection and replacement Model 767 (442 airplanes) Up to 9 work-hours × $85 per hour = Up to $765 Up to $18,000 Up to $18,765 Up to $8,294,130. For the maintenance/inspection program revision, we have determined that this action takes an average of 90 work-hours per operator, although we recognize that this number may vary from operator to operator. In the past, we have estimated that this action takes 1 work-hour per airplane. Since operators incorporate maintenance or inspection program changes for their affected fleets, we have determined that a per-operator estimate is more accurate than a per-airplane estimate. Therefore, we estimate the total cost per operator to be $7,650 (90 work-hours × $85 per work-hour). Authority for This Rulemaking Title 49 of the United States Code specifies the FAA's authority to issue rules on aviation safety. Subtitle I, section 106, describes the authority of the FAA Administrator. Subtitle VII: Aviation Programs, describes in more detail the scope of the Agency's authority. We are issuing this rulemaking under the authority described in Subtitle VII, Part A, Subpart III, Section 44701: “General requirements.” Under that section, Congress charges the FAA with promoting safe flight of civil aircraft in air commerce by prescribing regulations for practices, methods, and procedures the Administrator finds necessary for safety in air commerce. This regulation is within the scope of that authority because it addresses an unsafe condition that is likely to exist or develop on products identified in this rulemaking action. This AD is issued in accordance with authority delegated by the Executive Director, Aircraft Certification Service, as authorized by FAA Order 8000.51C. In accordance with that order, issuance of ADs is normally a function of the Compliance and Airworthiness Division, but during this transition period, the Executive Director has delegated the authority to issue ADs applicable to transport category airplanes and associated appliances to the Director of the System Oversight Division. Regulatory Findings This AD will not have federalism implications under Executive Order 13132. This AD will not have a substantial direct effect on the States, on the relationship between the national government and the States, or on the distribution of power and responsibilities among the various levels of government. For the reasons discussed above, I certify that this AD:

(1)Is not a “significant regulatory action” under Executive Order 12866,

(2)Is not a “significant rule” under DOT Regulatory Policies and Procedures (44 FR 11034, February 26, 1979),

(3)Will not affect intrastate aviation in Alaska, and

(4)Will not have a significant economic impact, positive or negative, on a substantial number of small entities under the criteria of the Regulatory Flexibility Act. List of Subjects in 14 CFR Part 39 Air transportation, Aircraft, Aviation safety, Incorporation by reference, Safety. Adoption of the Amendment Accordingly, under the authority delegated to me by the Administrator, the FAA amends 14 CFR part 39 as follows: PART 39—AIRWORTHINESS DIRECTIVES 1. The authority citation for part 39 continues to read as follows: Authority: 49 U.S.C. 106(g), 40113, 44701. § 39.13 [Amended] 2. The FAA amends § 39.13 by adding the following new airworthiness directive (AD): **2018-20-13 The Boeing Company:** Amendment 39-19447; Docket No. FAA-2017-0127; Product Identifier 2016-NM-161-AD.

(a)Effective Date This AD is effective November 15, 2018.

(b)Affected ADs This AD affects AD 2015-21-09, Amendment 39-18302 (80 FR 65121, October 26, 2015) (“AD 2015-21-09”); AD 2015-19-04, Amendment 39-18267, (80 FR 55505, September 16, 2015) (“AD 2015-19-04”); and AD 2015-21-10, Amendment 39-18303 (80 FR 65130, October 26, 2015) (“AD 2015-21-10”).

(c)Applicability This AD applies to all The Boeing Company airplanes, certificated in any category, identified in paragraphs (c)(1), (c)(2), and (c)(3) of this AD.

(1)Model 737 airplanes, excluding Model 737-100, -200, -200C, -300, -400, and -500 series airplanes.

(2)Model 757-200, -200PF, -200CB, and -300 series airplanes.

(3)Model 767-200, -300, -300F, and -400ER series airplanes.

(d)Subject Air Transport Association

(ATA)of America Code 28; Fuel.

(e)Unsafe Condition This AD was prompted by reports of latently failed motor-operated valve

(MOV)actuators of the fuel shutoff valves. We are issuing this AD to prevent a latent failure of the actuator for the engine or auxiliary power unit

(APU)fuel shutoff valves, which could result in the inability to shut off fuel to the engine or the APU, and, in case of certain engine or APU fires, could result in structural failure.

(f)Compliance Comply with this AD within the compliance times specified, unless already done.

(g)Inspection To Determine Part Number (P/N)

(1)For Model 737-600, -700, -700C, -800, -900, and -900ER series airplanes: Within 8 years after the effective date of this AD, do an inspection to determine the part numbers of the MOV actuators of the fuel shutoff valves for the left and right engines, in accordance with the Accomplishment Instructions of Boeing Service Bulletin 737-28-1314, dated November 17, 2014. A review of airplane maintenance records is acceptable in lieu of this inspection if the part number of the MOV actuator at each location can be conclusively determined from that review.

(2)For airplanes identified in paragraphs (c)(2) and (c)(3) of this AD: Within 8 years after the effective date of this AD, do an inspection to determine the part numbers of the MOV actuators of the fuel shutoff valves for the left and right engines, and of the APU fuel shutoff valve, in accordance with the Accomplishment Instructions of Boeing Special Attention Service Bulletin 757-28-0138, Revision 1, dated June 19, 2017 (“SB 757-28-0138 R1”); or Boeing Service Bulletin 767-28-0115, Revision 1, dated June 2, 2016 (“SB 767-28-0115 R1”); as applicable. A review of airplane maintenance records is acceptable in lieu of this inspection if the part number of the MOV actuator at each location can be conclusively determined from that review.

(h)Replacement

(1)For Model 737-600, -700, -700C, -800, -900, and -900ER series airplanes on which any MOV actuator having P/N MA20A2027 or P/N MA30A1001 (Boeing P/N S343T003-56 or Boeing P/N S343T003-66, respectively), is found during the inspection required by paragraph (g)(1) of this AD: Within 8 years after the effective date of this AD, replace each affected MOV actuator with an MOV actuator having P/N MA30A1017 (Boeing P/N S343T003-76), in accordance with the Accomplishment Instructions of Boeing Service Bulletin 737-28-1314, dated November 17, 2014. Where Boeing Service Bulletin 737-28-1314, dated November 17, 2014, specifies the installation of a new MOV actuator, this AD allows the installation of a new or serviceable MOV actuator. While not required by this AD, the Accomplishment Instructions specified in Boeing Service Bulletin 737-28-1314, dated November 17, 2014, for replacing MOV actuators having Boeing P/N S343T003-66 or Boeing P/N S343T003-56 may be used for replacing MOV actuators having P/N MA20A1001-1 (Boeing P/N S343T003-39).

(2)For airplanes identified in paragraph (c)(2) of this AD on which any MOV actuator having P/N MA20A2027 or P/N MA30A1001 (Boeing P/N S343T003-56 or Boeing P/N S343T003-66, respectively) is found during the inspection required by paragraph (g)(2) of this AD: Within 8 years after the effective date of this AD, replace each affected MOV actuator with an MOV actuator having P/N MA30A1017 (Boeing P/N S343T003-76), P/N AV-31-1 (Boeing P/N S343T003-111), or P/N MA11A1265-1 (Boeing P/N S343T003-41), in accordance with the Accomplishment Instructions of SB 757-28-0138 R1. Where SB 757-28-0138 R1 specifies the installation of a new MOV actuator, this AD allows the installation of a new or serviceable MOV actuator. While not required by this AD, the Accomplishment Instructions specified in SB 757-28-0138 R1 for replacing MOV actuators having Boeing P/N S343T003-66 or Boeing P/N S343T003-56 may be used for replacing MOV actuators having P/N MA20A1001-1 (Boeing P/N S343T003-39).

(3)For airplanes identified in paragraph (c)(3) of this AD on which any MOV actuator having P/N MA20A2027 (Boeing P/N S343T003-56) or P/N MA30A1001 (Boeing P/N S343T003-66) is found during the inspection required by paragraph (g)(2) of this AD: Within 8 years after the effective date of this AD, replace each affected MOV actuator with an MOV actuator having P/N MA30A1017 (Boeing P/N S343T003-76), P/N AV-31-1 (Boeing P/N S343T003-111), P/N MA11A1265 (Boeing P/N S343T003-14), or P/N MA11A1265-1 (Boeing P/N S343T003-41), in accordance with the Accomplishment Instructions of SB 767-28-0115 R1. Where SB 767-28-0115 R1 specifies the installation of a new MOV actuator, this AD allows the installation of a new or serviceable MOV actuator. While not required by this AD, the Accomplishment Instructions specified in SB 767-28-0115 R1, for replacing MOV actuators having Boeing P/N S343T003-66 or Boeing P/N S343T003-56 may be used for replacing MOV actuators having P/N MA20A1001-1 (Boeing P/N S343T003-39).

(i)Maintenance or Inspection Program Revision

(1)For Model 737-600, -700, -700C, -800, -900, and -900ER series airplanes with an original certificate of airworthiness or original export certificate of airworthiness issued on or before the effective date of this AD: Prior to or concurrently with the actions required by paragraph (h)(1) of this AD or within 30 days after the effective date of this AD, whichever is later, revise the maintenance or inspection program, as applicable, to add the airworthiness limitations

(AWLs)specified in paragraphs (i)(1)(i), (i)(1)(ii), and (i)(1)(iii) of this AD. The initial compliance time for accomplishing the actions required by AWL No. 28-AWL-24 is within 6 years since the most recent inspection was performed in accordance with AWL No. 28-AWL-24, or within 6 years since the actions specified in Boeing Alert Service Bulletin 737-28A1207 were accomplished, whichever is later.

(i)AWL No. 28-AWL-21, Motor Operated Valve

(MOV)Actuator—Lightning and Fault Current Protection Electrical Bond, as specified in Boeing 737-600/700/700C/800/900/900ER Special Compliance Items/Airworthiness Limitations, D626A001-9-04, Revision June 2018.

(ii)AWL No. 28-AWL-22, Motor Operated Valve

(MOV)Actuator—Electrical Design Feature, as specified in Boeing 737-600/700/700C/800/900/900ER Special Compliance Items/Airworthiness Limitations, D626A001-9-04, Revision June 2018.

(iii)AWL No. 28-AWL-24, Spar Valve Motor Operated Valve

(2)For airplanes identified in paragraph (c)(2) of this AD: Prior to or concurrently with the actions required by paragraph (h)(2) of this AD, revise the maintenance or inspection program, as applicable, to add the AWLs specified in paragraphs (i)(2)(i), (i)(2)(ii), and (i)(2)(iii) of this AD. The initial compliance time for accomplishing the actions required by AWL No. 28-AWL-25 is within 6 years since the most recent inspection was performed in accordance with AWL No. 28-AWL-25, or within 6 years since the actions specified in Boeing Alert Service Bulletin 757-28A0088 were accomplished, whichever is later.

(i)AWL No. 28-AWL-23, Motor Operated Valve

(MOV)Actuator—Lightning and Fault Current Protection Electrical Bond, as specified in Boeing 757 Maintenance Planning Data

(MPD)Document, Section 9, Airworthiness Limitations

(AWLs)and Certification Maintenance Requirements (CMRs), D622N001-9, Revision May 2018.

(ii)AWL No. 28-AWL-24, MOV Actuator—Electrical Design Feature, as specified in Boeing 757 Maintenance Planning Data

(MPD)Document, Section 9, Airworthiness Limitations

(AWLs)and Certification Maintenance Requirements (CMRs), D622N001-9, Revision May 2018.

(iii)AWL No. 28-AWL-25, Motor Operated Valve

(MOV)Actuator—Lightning and Fault Current Protection Electrical Bond, as specified in Boeing 757 Maintenance Planning Data

(MPD)Document, Section 9, Airworthiness Limitations

(AWLs)and Certification Maintenance Requirements (CMRs), D622N001-9, Revision May 2018.

(3)For airplanes identified in paragraph (c)(3) of this AD with an original certificate of airworthiness or original export certificate of airworthiness issued on or before the effective date of this AD: Prior to or concurrently with the actions required by paragraph (h)(3) of this AD, revise the maintenance or inspection program, as applicable, to add the AWLs specified in paragraphs (i)(3)(i) and (i)(3)(ii) of this AD.

(i)AWL No. 28-AWL-23, Motor Operated Valve

(MOV)Actuator—Lightning and Fault Current Protection Electrical Bond, as specified in Boeing 767-200/300/300F/400 Special Compliance Items/Airworthiness Limitations, D622T001-9-04, Revision March 2018.

(ii)AWL No. 28-AWL-24, Motor Operated Valve

(MOV)Actuator—Electrical Design Feature, as specified in Boeing 767-200/300/300F/400 Special Compliance Items/Airworthiness Limitations, D622T001-9-04, Revision March 2018.

(j)Maintenance or Inspection Program Revision for Parts Installation Prohibition

(1)For Model 737-600, -700, -700C, -800, -900, and -900ER series airplanes: After accomplishing the actions required by paragraphs (g)(1), (h)(1), and (i)(1) of this AD, as applicable, on all airplanes in an operator's fleet, and within 8 years after the effective date of the AD, revise the maintenance or inspection program, as applicable, by incorporating the AWL specified in figure 1 to paragraph (j)(1) of this AD. BILLING CODE 1301-00-D ER17OC18.019

(2)For airplanes identified in paragraph (c)(2) of this AD: After accomplishing the actions required by paragraphs (g)(2), (h)(2), and (i)(2) of this AD, as applicable, on all airplanes in an operator's fleet, and within 8 years after the effective date of the AD, revise the maintenance or inspection program, as applicable, by incorporating the AWL specified in figure 2 to paragraph (j)(2) of this AD. ER17OC18.020

(3)For airplanes identified in paragraph (c)(3) of this AD: After accomplishing the actions required by paragraphs (g)(2), (h)(3), and (i)(3) of this AD, as applicable, on all airplanes in an operator's fleet, and within 8 years after the effective date of the AD, revise the maintenance or inspection program, as applicable, by incorporating the AWL specified in figure 3 to paragraph (j)(3) of this AD. ER17OC18.021

(4)For airplanes identified in paragraph (c)(1) of this AD, excluding Model 737-600, -700, -700C, -800, -900, and -900ER series airplanes: Within 30 days since the date of issuance of the original standard airworthiness certificate or the date of issuance of the original export certificate of airworthiness, or within 30 days after the effective date of this AD, whichever is later, revise the maintenance or inspection program, as applicable, by incorporating the AWL specified in figure 4 to paragraph (j)(4) of this AD. ER17OC18.022 BILLING CODE 1301-00-C

(k)No Alternative Actions, Intervals, and Critical Design Configuration Control Limitations (CDCCLs)

(1)After the maintenance or inspection program has been revised as required by paragraph

(i)of this AD, no alternative actions ( *e.g.,* inspections), intervals, or CDCCLs, may be used unless the actions, intervals, and CDCCLs are approved as an alternative method of compliance

(AMOC)in accordance with the procedures specified in paragraph

(o)of this AD.

(2)After the maintenance or inspection program has been revised as required by paragraph

(j)of this AD, no alternative actions ( *e.g.,* inspections), intervals, or CDCCLs, may be used unless the actions, intervals, and CDCCLs are approved as an AMOC in accordance with the procedures specified in paragraph

(o)of this AD.

(l)Parts Installation Prohibition

(1)For Model 737-600, -700, -700C, -800, -900, and -900ER series airplanes: As of the effective date of this AD, no person may replace an MOV actuator having P/N MA30A1017 (Boeing P/N S343T003-76) with an MOV actuator having P/N MA20A2027 or P/N MA30A1001 (Boeing P/N S343T003-56 or Boeing P/N S343T003-66, respectively) for the left engine and right engine fuel shutoff valves.

(2)For airplanes identified in paragraph (c)(2) of this AD: As of the effective date of this AD, no person may replace an MOV actuator having P/N AV-31-1 (Boeing P/N S343T003-111), P/N MA11A1265 (Boeing P/N S343T003-14), P/N MA11A1265-1 (Boeing P/N S343T003-41), or P/N MA30A1017 (Boeing P/N S343T003-76) with an MOV actuator having P/N MA30A1001 (Boeing P/N S343T003-66) or P/N MA20A2027 (Boeing P/N S343T003-56) for the left engine and right engine fuel shutoff valves and the APU fuel shutoff valve.

(3)For airplanes identified in paragraph (c)(3) of this AD: As of the effective date of this AD, no person may replace an MOV actuator having P/N AV-31-1 (Boeing P/N S343T003-111), P/N MA11A1265 (Boeing P/N S343T003-14), P/N MA11A1265-1 (Boeing P/N S343T003-41), or P/N MA30A1017 (Boeing P/N S343T003-76) with an MOV actuator having P/N MA30A1001 (Boeing P/N S343T003-66) or P/N MA20A2027 (Boeing P/N S343T003-56) for the left engine and right engine fuel shutoff valves and the APU fuel shutoff valve.

(4)For airplanes identified in paragraph (c)(1) of this AD, excluding Model 737-600, -700, -700C, -800, -900, and -900ER series airplanes: As of the effective date of this AD, no person may install an MOV actuator having P/N MA20A1001-1 (Boeing P/N S343T003-39) or replace an MOV actuator with an MOV actuator having P/N MA20A2027 or P/N MA30A1001 (Boeing P/N S343T003-56 or Boeing P/N S343T003-66, respectively) for the left engine and right engine fuel shutoff valves.

(m)Terminating Action

(1)For Model 737-600, -700, -700C, -800, -900, and -900ER series airplanes: Accomplishing the actions required by paragraph (j)(l) of this AD terminates the requirements of paragraph (l)(1) of this AD and all requirements of AD 2015-21-10.

(2)For airplanes identified in paragraph (c)(2) of this AD: Accomplishing the action required by paragraph (j)(2) of this AD terminates the requirements of paragraph (l)(2) of this AD and all requirements of AD 2015-19-04.

(3)For airplanes identified in paragraph (c)(3) of this AD: Accomplishing the action required by paragraph (j)(3) of this AD terminates the requirements of paragraph (l)(3) of this AD and all requirements of AD 2015-21-09.

(4)For airplanes identified in paragraph (c)(1) of this AD, excluding Model 737-600, -700, -700C, -800, -900, and -900ER series airplanes: Accomplishing the action required by paragraph (j)(4) of this AD terminates the requirements of paragraph (l)(4) of this AD.

(n)Credit for Previous Actions

(1)This paragraph provides credit for the actions specified in paragraph (g)(2) or (h)(2) of this AD, as applicable, if those actions were performed before the effective date of this AD using Boeing Special Attention Service Bulletin 757-28-0138, dated May 18, 2016.

(2)This paragraph provides credit for the actions specified in paragraph (g)(2) or (h)(3) of this AD, as applicable, if those actions were performed before the effective date of this AD using Boeing Service Bulletin 767-28-0115, dated September 10, 2015.

(3)For Model 737-600, -700, -700C, -800, -900, and -900ER series airplanes with an original certificate of airworthiness or original export certificate of airworthiness issued on or before the effective date of this AD, this paragraph provides credit for the actions specified in paragraph (i)(1) of this AD if those actions were performed before the effective date of this AD using Boeing 737-600/700/700C/800/900/900ER Special Compliance Items/Airworthiness Limitations, D626A001-9-04, Revision July 2016, Revision September 2016, Revision January 2017, Revision April 2018, or Revision May 2018; or Boeing 737-600/700/700C/800/900/900ER Maintenance Planning Data

(MPD)Document, Section 9, Airworthiness Limitations

(AWLs)and Certification Maintenance Requirements (CMRs), D626A001-CMR, Revision October 2014, Revision November 2014, Revision January 2015, or Revision April 2016.

(4)For airplanes identified in paragraph (c)(2) of this AD, this paragraph provides credit for the actions specified in paragraph (i)(2) of this AD if those actions were performed before the effective date of this AD using Boeing 757 Maintenance Planning Data

(MPD)Document, Section 9, Airworthiness Limitations

(AWLs)and Certification Maintenance Requirements (CMRs), D622N001-9, Revision January 2016, Revision July 2016, or Revision February 2017.

(5)For airplanes identified in paragraph (c)(3) of this AD with an original certificate of airworthiness or original export certificate of airworthiness issued on or before the effective date of this AD, this paragraph provides credit for the actions specified in paragraph (i)(3) of this AD if those actions were performed before the effective date of this AD using Boeing 767 Special Compliance Items/Airworthiness Limitations, D622T001-9-04, Revision July 2015, Revision March 2016, Revision May 2016, Revision May 2016 R1, or Revision June 2016; or Boeing 767-200/300/300F/400 Special Compliance Items/Airworthiness Limitations, D622T001-9-04, Revision January 2018.

(6)For airplanes identified in paragraph (c)(3) of this AD with an original certificate of airworthiness or original export certificate of airworthiness issued on or before the effective date of this AD, this paragraph provides credit for the actions specified in paragraph (i)(3)(ii) of this AD if those actions were performed before the effective date of this AD using Boeing 767 Special Compliance Items/Airworthiness Limitations, D622T001-9-04, Revision October 2014.

(o)Alternative Methods of Compliance (AMOCs)

(1)The Manager, Seattle ACO Branch, FAA, has the authority to approve AMOCs for this AD, if requested using the procedures found in 14 CFR 39.19. In accordance with 14 CFR 39.19, send your request to your principal inspector or local Flight Standards District Office, as appropriate. If sending information directly to the manager of the certification office, send it to the attention of the person identified in paragraph (p)(1) of this AD. Information may be emailed to: *9-ANM-Seattle-ACO-AMOC-Requests@faa.gov.*

(2)Before using any approved AMOC, notify your appropriate principal inspector, or lacking a principal inspector, the manager of the local flight standards district office/certificate holding district office.

(3)An AMOC that provides an acceptable level of safety may be used for any repair, modification, or alteration required by this AD if it is approved by the Boeing Commercial Airplanes Organization Designation Authorization

(ODA)that has been authorized by the Manager, Seattle ACO Branch, to make those findings. To be approved, the repair method, modification deviation, or alteration deviation must meet the certification basis of the airplane, and the approval must specifically refer to this AD.

(4)For service information that contains steps that are labeled as Required for Compliance (RC), the provisions of paragraphs (o)(4)(i) and (o)(4)(ii) of this AD apply.

(i)The steps labeled as RC, including substeps under an RC step and any figures identified in an RC step, must be done to comply with the AD. If a step or substep is labeled “RC Exempt,” then the RC requirement is removed from that step or substep. An AMOC is required for any deviations to RC steps, including substeps and identified figures.

(ii)Steps not labeled as RC may be deviated from using accepted methods in accordance with the operator's maintenance or inspection program without obtaining approval of an AMOC, provided the RC steps, including substeps and identified figures, can still be done as specified, and the airplane can be put back in an airworthy condition.

(p)Related Information

(1)For more information about this AD, contact Tak Kobayashi, Aerospace Engineer, Propulsion Section, FAA, Seattle ACO Branch, 2200 South 216th St., Des Moines, WA 98198; phone and fax: 206-231-3553; email: *Takahisa.Kobayashi@faa.gov.*

(2)Service information identified in this AD that is not incorporated by reference is available at the addresses specified in paragraphs (q)(3) and (q)(4) of this AD.

(q)Material Incorporated by Reference

(1)The Director of the Federal Register approved the incorporation by reference

(IBR)of the service information listed in this paragraph under 5 U.S.C. 552(a) and 1 CFR part 51.

(2)You must use this service information as applicable to do the actions required by this AD, unless the AD specifies otherwise.

(i)Boeing 737-600/700/700C/800/900/900ER Special Compliance Items/Airworthiness Limitations, D626A001-9-04, Revision June 2018.

(ii)Boeing 757 Maintenance Planning Data

(MPD)Document, Section 9, Airworthiness Limitations

(AWLs)and Certification Maintenance Requirements (CMRs), D622N001-9, Revision May 2018.

(iii)Boeing 767-200/300/300F/400ER Special Compliance Items/Airworthiness Limitations, D622T001-9-04, Revision March 2018.

(iv)Boeing Service Bulletin 737-28-1314, dated November 17, 2014.

(v)Boeing Service Bulletin 767-28-0115, Revision 1, dated June 2, 2016.

(vi)Boeing Special Attention Service Bulletin 757-28-0138, Revision 1, dated June 19, 2017.

(3)For service information identified in this AD, contact Boeing Commercial Airplanes, Attention: Contractual & Data Services (C&DS), 2600 Westminster Blvd., MC 110-SK57, Seal Beach, CA 90740-5600; telephone: 562-797-1717; internet: *https://www.myboeingfleet.com.*

(4)You may view this service information at the FAA, Transport Standards Branch, 2200 South 216th St., Des Moines, WA. For information on the availability of this material at the FAA, call 206-231-3195.

(5)You may view this service information that is incorporated by reference at the National Archives and Records Administration (NARA). For information on the availability of this material at NARA, call 202-741-6030, or go to: *http://www.archives.gov/federal-register/cfr/ibr-locations.html.* Issued in Des Moines, Washington, on September 14, 2018. John P. Piccola, Acting Director, System Oversight Division, Aircraft Certification Service. [FR Doc. R1-2018-21460 Filed 10-16-18; 8:45 am] BILLING CODE 1301-00-D DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration 21 CFR Part 866 [Docket No. FDA-2018-N-3596] Medical Devices; Immunology and Microbiology Devices; Classification of the Herpes Virus Nucleic Acid-Based Cutaneous and Mucocutaneous Lesion Panel AGENCY: Food and Drug Administration, HHS. ACTION: Final order. SUMMARY: The Food and Drug Administration (FDA or we) is classifying the herpes virus nucleic acid-based cutaneous and mucocutaneous lesion panel into class II (special controls). The special controls that apply to the device type are identified in this order and will be part of the codified language for the herpes virus nucleic acid-based cutaneous and mucocutaneous lesion panel's classification. We are taking this action because we have determined that classifying the device into class II (special controls) will provide a reasonable assurance of safety and effectiveness of the device. We believe this action will also enhance patients' access to beneficial innovative devices, in part by reducing regulatory burdens. DATES: This order is effective October 17, 2018. The classification was applicable on May 13, 2014. FOR FURTHER INFORMATION CONTACT: Scott McFarland, Center for Devices and Radiological Health, Food and Drug Administration, 10903 New Hampshire Ave., Bldg. 66, Rm. 4676, Silver Spring, MD, 20993-0002, 301-796-6217, *scott.mcfarland@fda.hhs.gov.* SUPPLEMENTARY INFORMATION: I. Background Upon request, FDA has classified the herpes virus nucleic acid-based cutaneous and mucocutaneous lesion panel as class II (special controls), which we have determined will provide a reasonable assurance of safety and effectiveness. In addition, we believe this action will enhance patients' access to beneficial innovation, in part by reducing regulatory burdens by placing the device into a lower device class than the automatic class III assignment. The automatic assignment of class III occurs by operation of law and without any action by FDA, regardless of the level of risk posed by the new device. Any device that was not in commercial distribution before May 28, 1976, is automatically classified as, and remains within, class III and requires premarket approval unless and until FDA takes an action to classify or reclassify the device (see 21 U.S.C. 360c(f)(1)). We refer to these devices as “postamendments devices” because they were not in commercial distribution prior to the date of enactment of the Medical Device Amendments of 1976, which amended the Federal Food, Drug, and Cosmetic Act (FD&C Act). FDA may take a variety of actions in appropriate circumstances to classify or reclassify a device into class I or II. We may issue an order finding a new device to be substantially equivalent under section 513(i) of the FD&C Act (21 U.S.C. 360c(i) to a predicate device that does not require premarket approval. We determine whether a new device is substantially equivalent to a predicate by means of the procedures for premarket notification under section 510(k) of the FD&C Act (21 U.S.C. 360(k)) and part 807 (21 CFR part 807). FDA may also classify a device through “De Novo” classification, a common name for the process authorized under section 513(f)(2) of the FD&C Act. Section 207 of the Food and Drug Administration Modernization Act of 1997 (Pub. L. 105-115) established the first procedure for De Novo classification. Section 607 of the Food and Drug Administration Safety and Innovation Act (Pub. L. 112-144) modified the De Novo application process by adding a second procedure. A device sponsor may utilize either procedure for De Novo classification. Under the first procedure, the person submits a 510(k) for a device that has not previously been classified. After receiving an order from FDA classifying the device into class III under section 513(f)(1) of the FD&C Act, the person then requests a classification under section 513(f)(2). Under the second procedure, rather than first submitting a 510(k) and then a request for classification, if the person determines that there is no legally marketed device upon which to base a determination of substantial equivalence, that person requests a classification under section 513(f)(2) of the FD&C Act. Under either procedure for De Novo classification, FDA is required to classify the device by written order within 120 days. The classification will be according to the criteria under section 513(a)(1) of the FD&C Act. Although the device was automatically placed within class III, the De Novo classification is considered to be the initial classification of the device. We believe this De Novo classification will enhance patients' access to beneficial innovation, in part by reducing regulatory burdens. When FDA classifies a device into class I or II via the De Novo process, the device can serve as a predicate for future devices of that type, including for 510(k)s (see 21 U.S.C. 360c(f)(2)(B)(i)). As a result, other device sponsors do not have to submit a De Novo request or premarket approval application

(PMA)to market a substantially equivalent device (see 21 U.S.C. 360c(i), defining “substantial equivalence”). Instead, sponsors can use the less-burdensome 510(k) process, when necessary, to market their device. II. De Novo Classification For this device, FDA issued an order on February 7, 2014, finding the Lyra TM Direct HSV 1 + 2/VZV Assay not substantially equivalent to a predicate not subject to PMA. Thus, the device remained in class III in accordance with section 513(f)(1) of the FD&C Act when we issued the order. On February 21, 2014, Quidel Corporation submitted a request for De Novo classification of the Lyra TM Direct HSV 1 + 2/VZV Assay. FDA reviewed the request in order to classify the device under the criteria for classification set forth in section 513(a)(1) of the FD&C Act. We classify devices into class II if general controls by themselves are insufficient to provide reasonable assurance of safety and effectiveness, but there is sufficient information to establish special controls that, in combination with the general controls, provide reasonable assurance of the safety and effectiveness of the device for its intended use (see 21 U.S.C. 360c(a)(1)(B)). After review of the information submitted in the request, we determined that the device can be classified into class II with the establishment of special controls. FDA has determined that these special controls, in addition to general controls, will provide reasonable assurance of the safety and effectiveness of the device. Therefore, on May 13, 2014, FDA issued an order to the requestor classifying the device into class II. FDA is codifying the classification of the device by adding 21 CFR 866.3309. We have named the generic type of device herpes virus nucleic acid-based cutaneous and mucocutaneous lesion panel, and it is identified as a qualitative in vitro diagnostic device intended for the simultaneous detection and differentiation of different herpes viruses in cutaneous and mucocutaneous lesion samples from symptomatic patients suspected of Herpetic infections. Negative results do not preclude infection and should not be used as the sole basis for treatment or other patient management decisions. The assay is not intended for use in cerebrospinal fluid samples. FDA has identified the following risks to health associated specifically with this type of device and the measures required to mitigate these risks in table 1. Table 1—Herpes Virus Nucleic Acid-Based Cutaneous and Mucocutaneous Lesion Panel Risks and Mitigation Measures Identified risks Mitigation measures Risk of false results Special controls

(1)(21 CFR 866.3309(b)(1)),

(2)(21 CFR 866.3309(b)(2)), and

(3)(21 CFR 866.3309(b)(3)). Failure to correctly interpret test results Special controls

(4)(21 CFR 866.3309(b)(4)) and

(5)(21 CFR 866.3309(b)(5)). Failure to correctly operate the instrument Special controls

(6)(21 CFR 866.3309(b)(6)) and

(7)(21 CFR 866.3309(b)(7)). FDA has determined that special controls, in combination with the general controls, address these risks to health and provide reasonable assurance of safety and effectiveness. For a device to fall within this classification, and thus avoid automatic classification in class III, it would have to comply with the special controls named in this final order. The necessary special controls appear in the regulation codified by this order. This device is subject to premarket notification requirements under section 510(k) of the FD&C Act. III. Analysis of Environmental Impact We have determined under 21 CFR 25.34(b) that this action is of a type that does not individually or cumulatively have a significant effect on the human environment. Therefore, neither an environmental assessment nor an environmental impact statement is required. IV. Paperwork Reduction Act of 1995 This final order establishes special controls that refer to previously approved collections of information found in other FDA regulations and guidance. These collections of information are subject to review by the Office of Management and Budget

(OMB)under the Paperwork Reduction Act of 1995 (44 U.S.C. 3501-3520). The collections of information in the guidance document “De Novo Classification Process (Evaluation of Automatic Class III Designation)” have been approved under OMB control number 0910-0844; the collections of information in 21 CFR part 814, subparts A through E, regarding premarket approval, have been approved under OMB control number 0910-0231; the collections of information in part 807, subpart E, regarding premarket notification submissions, have been approved under OMB control number 0910-0120; the collections of information in 21 CFR part 820, regarding quality system regulations, have been approved under OMB control number 0910-0073; and the collections of information in 21 CFR parts 801 and 809, regarding labeling, have been approved under OMB control number 0910-0485. List of Subjects in 21 CFR Part 866 Biologics; Laboratories; Medical devices. Therefore, under the Federal Food, Drug, and Cosmetic Act and under authority delegated to the Commissioner of Food and Drugs, 21 CFR part 866 is amended as follows: PART 866—IMMUNOLOGY AND MICROBIOLOGY DEVICES 1. The authority citation for 21 CFR part 866 continues to read as follows: Authority: 21 U.S.C. 351, 360, 360c, 360e, 360j, 360 *l,* 371. 2. Add § 866.3309 to subpart D to read as follows: § 866.3309 Herpes virus nucleic acid-based cutaneous and mucocutaneous lesion panel.

(a)*Identification.* A herpes virus nucleic acid-based cutaneous and mucocutaneous lesion panel is a qualitative in vitro diagnostic device intended for the simultaneous detection and differentiation of different herpes viruses in cutaneous and mucocutaneous lesion samples from symptomatic patients suspected of Herpetic infections. Negative results do not preclude infection and should not be used as the sole basis for treatment or other patient management decisions. The assay is not intended for use in cerebrospinal fluid samples.

(b)*Classification.* Class II (special controls). The special controls for this device are:

(1)Premarket notification submissions must include detailed documentation for the device description, including the device components, ancillary reagents required but not provided, and a detailed explanation of the methodology including primer design and selection.

(2)Premarket notification submissions must include detailed documentation from the following analytical and clinical performance studies: Analytical sensitivity (Limit of Detection), reactivity, inclusivity, precision, reproducibility, interference, cross reactivity, carry-over, and cross contamination.

(3)Premarket notification submissions must include detailed documentation of a clinical study using lesion samples in which Herpes Simplex Virus 1, Herpes Simplex Virus 2, or Varicella Zoster Virus DNA detection was requested. The study must compare the device performance to an appropriate well established reference method.

(4)A detailed explanation of the interpretation of results and acceptance criteria must be included in the device's 21 CFR 809.10(b)(9) compliant labeling.

(5)The device labeling must include a limitation statement that reads: “The device is not intended for use with cerebrospinal fluid or to aid in the diagnosis of HSV or VZV infections of the central nervous system (CNS).”

(6)Premarket notification submissions must include quality assurance protocols and a detailed documentation for device software, including, but not limited to, standalone software applications and hardware-based devices that incorporate software.

(7)The risk management activities performed as part of the manufacturer's 21 CFR 820.30 design controls must document an appropriate end user device training program that will be offered as part of efforts to mitigate the risk of failure to correctly operate the instrument. Dated: October 12, 2018. Leslie Kux, Associate Commissioner for Policy. [FR Doc. 2018-22694 Filed 10-16-18; 8:45 am]

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