November 10, 2020 – Federal Register Recent Federal Regulation Documents

Enhancing the Diversity of Clinical Trial Populations-Eligibility Criteria, Enrollment Practices, and Trial Designs; Guidance for Industry; Availability
Document Number: 2020-24881
Type: Notice
Date: 2020-11-10
Agency: Food and Drug Administration, Department of Health and Human Services
The Food and Drug Administration (FDA or Agency) is announcing the availability of a final guidance for industry entitled ``Enhancing the Diversity of Clinical Trial PopulationsEligibility Criteria, Enrollment Practices, and Trial Designs.'' This guidance recommends approaches that sponsors of clinical trials intended to support a new drug application or a biologics license application can take to increase enrollment of underrepresented populations in their clinical trials. This guidance is being issued, in part, to satisfy the mandates of the FDA Reauthorization Act of 2017 (FDARA). This guidance finalizes the draft guidance of the same title issued on June 7, 2019.
Public Availability of the Securities and Exchange Commission's FY 2016 and FY 2017 Service Contract Inventory
Document Number: 2020-24880
Type: Notice
Date: 2020-11-10
Agency: Securities and Exchange Commission, Agencies and Commissions
In accordance with Section 743 of Division C of the Consolidated Appropriations Act of 2010 (Pub. L. 111-117), SEC is publishing this notice to advise the public of the availability of the FY2017 Service Contract Inventory (SCI) and the FY2016 SCI Analysis along with the FY2018 Service Contract Inventory (SCI) and the FY2017 SCI Analysis. The SCI provides information on FY2016 and FY2017 actions over $150,000 for service contracts. The inventory organizes the information by function to show how SEC distributes contracted resources throughout the agency. SEC developed the inventory per the guidance issued on January 17, 2017 by the Office of Management and Budget's Office of Federal Procurement Policy (OFPP). OFPP's guidance is available at https://www.whitehouse.gov/sites/whitehouse.gov/files/omb/mem oranda/ 2017/service_contract_inventories.pdf. The Service Contract Inventory Analysis for FY2016 provides information based on the FY 2016 Inventory and the Service Contract Inventory Analysis for FY2017 provides information based on the FY 2017 Inventory. Please note that the SEC's FY 2016 and FY 2017 Service Contract Inventory data is now included in government-wide inventory available on www.acquisition.gov. The government-wide inventory can be filtered to display the inventory data for the SEC. The SEC has posted its FY 2017 and FY2018 plans for analyzing data, a link to the FY 2017 and 2018 government-wide Service Contract Inventory, the FY 2016 SCI Analysis, and the FY 2017 SCI Analysis on the SEC's homepage at https:// www.sec.gov/about/secreports.shtml and https://www.sec.gov/open.
Principal Diversified Select Real Asset Fund, et al.
Document Number: 2020-24879
Type: Notice
Date: 2020-11-10
Agency: Securities and Exchange Commission, Agencies and Commissions
Proposed Amendment of Class E Airspace; Kankakee, IL
Document Number: 2020-24878
Type: Proposed Rule
Date: 2020-11-10
Agency: Federal Aviation Administration, Department of Transportation
This action proposes to amend the Class E airspace extending upward from 700 feet above the surface at Greater Kankakee Airport, Kankakee, IL. The FAA is proposing this action as the result of an airspace review caused by the decommissioning of the Kankakee VHF omnidirectional range (VOR) navigation aid as part of the VOR Minimum Operational Network (MON) Program.
Airworthiness Directives; Airbus Defense and Space S.A. (Formerly Known as Construcciones Aeronauticas, S.A.) Airplanes
Document Number: 2020-24876
Type: Proposed Rule
Date: 2020-11-10
Agency: Federal Aviation Administration, Department of Transportation
The FAA proposes to adopt a new airworthiness directive (AD) for all Airbus Defense and Space S.A. Model CN-235, CN-235-100, CN-235- 200, CN-235-300 airplanes and Model C-295 airplanes. This proposed AD was prompted by cracks found on certain left- and right-hand stringers in a certain area of the fuselage. This proposed AD would require repetitive inspections for cracking or broken rivets of certain left- and right-hand stringers and surrounding structure, and repair if necessary, as specified in a European Union Aviation Safety Agency (EASA) AD, which will be incorporated by reference. The FAA is proposing this AD to address the unsafe condition on these products.
Military Reservist Economic Injury Disaster Loans; Interest Rate for First Quarter FY 2021
Document Number: 2020-24875
Type: Notice
Date: 2020-11-10
Agency: Small Business Administration, Agencies and Commissions
This is a notice of the Military Reservist Economic Injury Disaster Loans interest rate for loans approved on or after October 30, 2020.
Agency Information Collection Activities: Requests for Comments; Clearance of Renewed; Approval of Information Collection: General Aviation and Part 135 Activity Survey
Document Number: 2020-24874
Type: Notice
Date: 2020-11-10
Agency: Federal Aviation Administration, Department of Transportation
The FAA's primary requirement is for annual hours flown, optimal determination of sample size is based on flight time variation by state and aircraft type, and a sampling fraction is determined for each cell with a no-zero population. Sample units are selected randomly within each stratum. Respondents to this survey are owners of general aviation aircraft. This information is used by FAA, NTSB, and other government agencies, the aviation industry, and others for safety assessment, planning, forecasting, cost/benefit analysis, and to target areas for research.
National Institute of Allergy and Infectious Diseases; Notice of Closed Meeting
Document Number: 2020-24873
Type: Notice
Date: 2020-11-10
Agency: Department of Health and Human Services, National Institutes of Health
Takes of Marine Mammals Incidental to Specified Activities; Taking Marine Mammals Incidental to the Berth III New Mooring Dolphins Project in Ketchikan, Alaska
Document Number: 2020-24871
Type: Notice
Date: 2020-11-10
Agency: Department of Commerce, National Oceanic and Atmospheric Administration
NMFS has received a request from the City of Ketchikan, Alaska (COK) for authorization to take marine mammals incidental to the Berth III New Mooring Dolphins Project in Ketchikan, AK. Pursuant to the Marine Mammal Protection Act (MMPA), NMFS is requesting comments on its proposal to issue an incidental harassment authorization (IHA) to incidentally take marine mammals during the specified activities. NMFS is also requesting comments on a possible one-time, one-year renewal that could be issued under certain circumstances and if all requirements are met, as described in Request for Public Comments at the end of this notice. NMFS will consider public comments prior to making any final decision on the issuance of the requested MMPA authorizations and agency responses will be summarized in the final notice of our decision.
Eunice Kennedy Shriver National Institute of Child Health & Human Development; Notice of Closed Meeting
Document Number: 2020-24870
Type: Notice
Date: 2020-11-10
Agency: Department of Health and Human Services, National Institutes of Health
Presidential Declaration Amendment of a Major Disaster for Public Assistance Only for the State of New York
Document Number: 2020-24869
Type: Notice
Date: 2020-11-10
Agency: Small Business Administration, Agencies and Commissions
This is an amendment of the Presidential declaration of a major disaster for Public Assistance Only for the State of NEW YORK (FEMA-4567-DR), dated 10/02/2020. Incident: Tropical Storm Isaias. Incident Period: 08/04/2020.
Agency Information Collection Activities; Submission to the Office of Management and Budget for Review and Approval; National Survey of Drowsy Driving Knowledge, Attitudes and Behaviors
Document Number: 2020-24868
Type: Notice
Date: 2020-11-10
Agency: National Highway Traffic Safety Administration, Department of Transportation
In compliance with the Paperwork Reduction Act of 1995 (PRA), this notice announces that the Information Collection Request (ICR) abstracted below will be submitted to the Office of Management and Budget (OMB) for review. The ICR describes the nature of the information collection and its expected burden. The ICR is for a new information collection for a one-time voluntary survey regarding knowledge, attitudes, and behaviors associated with drowsy driving. A Federal Register notice with a 60-day comment period soliciting public comments on the following information collection was published on July 14, 2020. NHTSA received two comments, which we address below.
Agency Information Collection Activities; Submission to the Office of Management and Budget for Review and Approval; Comment Request; 21st CCLC 4201(b)(1) Waiver Request
Document Number: 2020-24867
Type: Notice
Date: 2020-11-10
Agency: Department of Education
In accordance with the Paperwork Reduction Act of 1995, ED is proposing an extension without change of a currently approved collection.
General Motors, LLC, Denial of Petition for Decision of Inconsequential Noncompliance
Document Number: 2020-24866
Type: Notice
Date: 2020-11-10
Agency: National Highway Traffic Safety Administration, Department of Transportation
General Motors, LLC (GM), has determined that the seat belt assemblies in certain model year (MY) 2017-2018 Chevrolet Silverado heavy duty and GMC Sierra heavy duty motor vehicles do not fully comply with Federal Motor Vehicle Safety Standard (FMVSS) No. 209, Seat Belt Assemblies. GM filed a noncompliance report dated September 14, 2017, and later amended it on September 22, 2017. GM also petitioned NHTSA on October 6, 2017, for a decision that the subject noncompliance is inconsequential as it relates to motor vehicle safety. This document announces the denial of GM's petition.
Airworthiness Directives; Rolls-Royce Corporation (Type Certificate Previously Held by Allison Engine Company) Turboprop Engines
Document Number: 2020-24865
Type: Rule
Date: 2020-11-10
Agency: Federal Aviation Administration, Department of Transportation
The FAA is adopting a new airworthiness directive (AD) for all Rolls-Royce Corporation (RRC) AE 2100A, AE 2100D2, AE 2100D2A, and AE 2100P model turboprop engines. This AD was prompted by a report of a propeller gearbox (PGB) development test conducted by the manufacturer, in which high vibration occurred due to a fatigue crack that initiated in the PGB shaft and carrier assembly. This AD requires assignment of usage hours to the PGB shaft and carrier assembly at the next engine shop visit and replacement of PGB shaft and carrier assemblies prior to exceeding the new life limits established by the manufacturer. The FAA is issuing this AD to address the unsafe condition on these products.
Combined Notice of Filings #1
Document Number: 2020-24864
Type: Notice
Date: 2020-11-10
Agency: Department of Energy, Federal Energy Regulatory Commission
Security Zone; Fleet Week Demonstration Area, San Diego Bay, San Diego, CA
Document Number: 2020-24863
Type: Rule
Date: 2020-11-10
Agency: Coast Guard, Department of Homeland Security
The Coast Guard is establishing a temporary 900-foot radius security zone on the navigable waters of the U.S. off of Broadway Pier in San Diego Bay, San Diego, CA, in support of Fleet Week San Diego on November 11, 2020. This action is necessary to provide for the safety and security of U.S. Coast Guard surface and aerial assets, crews and support personnel who will be performing mission search and rescue demonstrations. This rulemaking prohibits persons and vessels from entering, transiting, or anchoring in the security zone unless authorized by the Captain of the Port San Diego or his designated representative.
Combined Notice of Filings
Document Number: 2020-24862
Type: Notice
Date: 2020-11-10
Agency: Department of Energy, Federal Energy Regulatory Commission
Pine Creek Mine, LLC; Notice of Effectiveness of Withdrawal of Petition for Declaratory Order
Document Number: 2020-24861
Type: Notice
Date: 2020-11-10
Agency: Department of Energy, Federal Energy Regulatory Commission
Special Local Regulation; Boat Parade; San Diego, CA
Document Number: 2020-24860
Type: Rule
Date: 2020-11-10
Agency: Coast Guard, Department of Homeland Security
The Coast Guard is establishing a temporary special local regulation (SLR) on the waters of San Diego Bay, California to provide for the safety of the participants, crew, spectators, sponsor vessels, and general users of the waterway during a boat parade. This SLR temporarily encompasses all navigable waters, from surface to bottom, on a pre-determined course in the northern portion of the San Diego Main Ship Channel from Shelter Island Basin, past the Embarcadero, crossing the federal navigable channel and ending off of Coronado Island.
RIN 1250-AA10
Document Number: 2020-24858
Type: Rule
Date: 2020-11-10
Agency: Department of Labor, Office of Federal Contract Compliance Programs
The U.S. Department of Labor (``the Department'') publishes this final rule to codify procedures that the Office of Federal Contract Compliance Programs (``OFCCP'' or ``the agency'') uses to resolve potential discrimination and other material violations of the laws and regulations administered by OFCCP applicable to Federal contractors and subcontractors, add clarifying definitions to specify the types of evidence OFCCP uses to support its discrimination findings, and correct the title of OFCCP's agency head.
Airworthiness Directives; Airbus SAS Airplanes
Document Number: 2020-24855
Type: Rule
Date: 2020-11-10
Agency: Federal Aviation Administration, Department of Transportation
The FAA is superseding Airworthiness Directive (AD) 2001-16- 13, which applied to certain Airbus SAS Model A330 series airplanes. AD 2001-16-13 required a roto-test inspection of fastener holes of certain fuselage joints for cracks, reinforcement of the fuselage between certain frames, and, if necessary, a high frequency eddy current (HFEC) inspection and repair. As published, the applicability of AD 2001-16-13 inadvertently identified the model designations as serial numbers. This document corrects that error. This new AD requires a roto-test inspection of fastener holes of certain fuselage joints for cracks, reinforcement of the fuselage, and, if necessary, an HFEC inspection and repair. The FAA is issuing this AD to address the unsafe condition on these products.
Airworthiness Directives; Airbus Helicopters
Document Number: 2020-24853
Type: Proposed Rule
Date: 2020-11-10
Agency: Federal Aviation Administration, Department of Transportation
The FAA proposes to supersede Airworthiness Directive (AD) 2018-19-01, which applies to all Airbus Helicopters Model AS-365N2, AS 365 N3, EC 155B, EC155B1, SA-365N1, and SA-366G1 helicopters. AD 2018- 19-01 requires repetitive inspections of the aft fuselage outer skin. Since the FAA issued AD 2018-19-01, it was determined that Model SA- 365N helicopters are also affected by the unsafe condition. This proposed AD would continue to require repetitive inspections and would add Model SA-365N helicopters, as specified in a European Union Aviation Safety Agency (EASA) AD, which will be incorporated by reference. The FAA is proposing this AD to address the unsafe condition on these products.
Consolidated Glass & Mirror, LLC, Receipt of Petitions for Decision of Inconsequential Noncompliance
Document Number: 2020-24825
Type: Notice
Date: 2020-11-10
Agency: National Highway Traffic Safety Administration, Department of Transportation
Consolidated Glass & Mirror, LLC (CGM), a subsidiary of Guardian Industries Corporation (Guardian), has determined that certain laminated glass parts do not fully comply with Federal motor vehicle safety standard (FMVSS) No. 205, Glazing Materials. Guardian filed two noncompliance reports dated April 15, 2020 and December 14, 2018 CGM petitioned NHTSA on May 23, 2018, and December 20, 2018, for a decision that the subject noncompliances are inconsequential as they relate to motor vehicle safety. This document announces receipt of CGM's petitions.
Revocation of Class E Airspace; Delavan, WI
Document Number: 2020-24810
Type: Rule
Date: 2020-11-10
Agency: Federal Aviation Administration, Department of Transportation
This action revokes the Class E airspace extending upward from 700 feet above the surface at Lake Lawn Airport, Delavan, WI, due to the cancellation of the instrument procedures at that airport and the airspace no longer being required.
Amendment of Class D and Class E Airspace; Waterloo, IA
Document Number: 2020-24809
Type: Rule
Date: 2020-11-10
Agency: Federal Aviation Administration, Department of Transportation
This action amends the Class D and Class E airspace at Waterloo Regional Airport, Waterloo, IA. This action is the result of an airspace review due to the closure of runway 6/24 at Waterloo Regional Airport. The names and geographic coordinates of the airport and navigational aids are also being updated to coincide with the FAA's aeronautical database.
Pacific Island Fisheries; Swordfish Trip Limits in the American Samoa Pelagic Longline Fishery
Document Number: 2020-24752
Type: Rule
Date: 2020-11-10
Agency: Department of Commerce, National Oceanic and Atmospheric Administration
This final rule removes the swordfish retention limit in the American Samoa deep-set longline fishery. The intent of this rule is to eliminate wasteful regulatory discards of marketable seafood, increasing efficiency and benefits to the local community and the Nation.
Terrorism Risk Insurance Program; Updated Regulations in Light of the Terrorism Risk Insurance Program Reauthorization Act of 2019, and for Other Purposes
Document Number: 2020-24522
Type: Proposed Rule
Date: 2020-11-10
Agency: Department of the Treasury
The Department of the Treasury (Treasury) is issuing proposed rules to implement technical changes to the Terrorism Risk Insurance Program (TRIP or Program) required by the Terrorism Risk Insurance Program Reauthorization Act of 2019 (2019 Reauthorization Act), and to update links to the Program's website, where additional information relating to the administration of the Program is located for public reference. In addition, Treasury is proposing rules to: Clarify the manner in which Treasury will calculate ``property and casualty insurance losses'' for purposes of considering certification of an act of terrorism, and ``insured losses'' when administering the financial sharing mechanisms under the Program, including the Program Trigger and Program Cap; and incorporate into the Program rules prior guidance provided by Treasury in connection with stand-alone cyber insurance under the Program. Treasury also seeks further public comment concerning the certification process under the Program, and the participation of captive insurers in the Program, to facilitate further analysis and study by the Federal Insurance Office (FIO) of the Program and potential future rulemakings in these areas.
Assessment and Collection of Regulatory Fees for Fiscal Year 2020
Document Number: 2020-24503
Type: Proposed Rule
Date: 2020-11-10
Agency: Federal Communications Commission, Agencies and Commissions
In this document, the Federal Communications Commission (Commission) seeks comment on several regulatory fee issues impacting international services.
Amendments to Capital Planning and Stress Testing Requirements for Large Bank Holding Companies, Intermediate Holding Companies and Savings and Loan Holding Companies; Correction
Document Number: 2020-24436
Type: Proposed Rule
Date: 2020-11-10
Agency: Federal Reserve System, Agencies and Commissions
This document corrects the portions of the discussion related to collections of information published with a proposed rule published in the Federal Register of October 7, 2020, regarding Amendments to Capital Planning and Stress Testing Requirements for Large Bank Holding Companies, Intermediate Holding Companies and Savings and Loan Holding Companies. This correction adds the OMB control number for the reporting form FR LL. In addition, the previously published document incorrectly listed the estimated recordkeeping burden associated with the FR YY information collection. This correction also provides a corrected burden estimate.
Acquisition Regulations; Buy Indian Act; Procedures for Contracting
Document Number: 2020-24339
Type: Proposed Rule
Date: 2020-11-10
Agency: Department of Health and Human Services, Indian Health Service
The United States Department of Health and Human Services (HHS) is proposing to issue regulations guiding implementation of the Buy Indian Act, which provides IHS with authority to set-aside procurement contracts for Indian-owned and controlled businesses.
Proposed Establishment of the Ulupalakua Viticultural Area
Document Number: 2020-24143
Type: Proposed Rule
Date: 2020-11-10
Agency: Alcohol and Tobacco Tax and Trade Bureau, Department of Treasury, Department of the Treasury
The Alcohol and Tobacco Tax and Trade Bureau (TTB) proposes to establish the approximately 70-acre ``Ulupalakua'' viticultural area on the island of Maui, Hawaii. The proposed viticultural area is not within any other established viticultural area. TTB designates viticultural areas to allow vintners to better describe the origin of their wines and to allow consumers to better identify wines they may purchase. TTB invites comments on this proposed addition to its regulations.
Proposed Expansion of the Clarksburg Viticultural Area
Document Number: 2020-24140
Type: Proposed Rule
Date: 2020-11-10
Agency: Alcohol and Tobacco Tax and Trade Bureau, Department of Treasury, Department of the Treasury
The Alcohol and Tobacco Tax and Trade Bureau (TTB) proposes to expand the approximately 64,640-acre ``Clarksburg'' viticultural area by approximately 27,945 acres. The Clarksburg viticultural area is located in Sacramento, Solano, and Yolo Counties, in California, and the proposed expansion area is located in Sacramento and Solano Counties. The established Clarksburg viticultural area and the proposed expansion area are not located within any established viticultural area. TTB designates viticultural areas to allow vintners to better describe the origin of their wines and to allow consumers to better identify wines they may purchase. TTB invites comments on this proposed amendment to its regulations.
Additional First Year Depreciation Deduction
Document Number: 2020-24026
Type: Proposed Rule
Date: 2020-11-10
Agency: Internal Revenue Service, Department of Treasury, Department of the Treasury
This document withdraws a portion of a notice of proposed rulemaking published in the Federal Register on September 24, 2019. The withdrawn portion relates to the extent to which a partner is deemed to have a depreciable interest in property held by a partnership.
Implementing Executive Order 13891; Promoting the Rule of Law Through Improved Agency Guidance Documents
Document Number: 2020-23982
Type: Rule
Date: 2020-11-10
Agency: Department of Housing and Urban Development
This interim rule implements Executive Order (E.O.) 13891, ``Promoting the Rule of Law Through Improved Agency Guidance Documents.'' This E.O. requires Federal agencies to publish regulations that establish processes and procedures for issuing guidance documents. The interim rule would create a new part 11 in title 24 of the Code of Federal Regulations (CFR) that outlines HUD policy on guidance documents and how HUD designates guidance documents. The interim rule would also establish a procedure by which the public may petition HUD for the withdrawal or modification of guidance documents, and the process for the public to make comments on certain significant guidance documents.
Burlington International Airport, South Burlington VT; FAA Approval of Noise Compatibility Program
Document Number: 2020-23279
Type: Notice
Date: 2020-11-10
Agency: Federal Aviation Administration, Department of Transportation
The Federal Aviation Administration (FAA) announces its findings on the noise compatibility program submitted by the City of Burlington, Vermont under the provisions of Title I of the Aviation Safety and Noise Abatement Act of 1979. These findings are made in recognition of the description of federal and non-federal responsibilities in Senate Report No. 96-52 (1980). On October 14, 2020, the Airports Division Deputy Director approved the Burlington International Airport noise compatibility program. This supersedes the approval issued August 27, 2020. All of the proposed program elements were approved.
Partial Approval and Partial Disapproval of Air Quality Implementation Plans; Arizona; Nonattainment Plan for the Hayden SO2
Document Number: 2020-23030
Type: Rule
Date: 2020-11-10
Agency: Environmental Protection Agency
The Environmental Protection Agency (EPA) is finalizing a partial approval and partial disapproval of an Arizona state implementation plan (SIP) revision for attaining the 2010 1-hour primary sulfur dioxide (SO2) national ambient air quality standard (NAAQS or ``standard'') for the Hayden SO2 nonattainment area (NAA). This SIP revision (hereinafter called the ``Hayden SO2 Plan'' or ``Plan'') includes Arizona's attainment demonstration and other elements required under the Clean Air Act (CAA or ``Act''). The EPA is approving the base year and projected emissions inventories and affirming that the new source review requirements for the area have been met. We are disapproving the attainment demonstration, as well as other elements of the Plan tied to this demonstration, namely, the requirement for meeting reasonable further progress (RFP) toward attainment of the NAAQS, reasonably available control measures and reasonably available control technology (RACM/RACT), enforceable emissions limitations and control measures, and contingency measures.
Compliance Requirements for Commodity Pool Operators on Form CPO-PQR
Document Number: 2020-22874
Type: Rule
Date: 2020-11-10
Agency: Commodity Futures Trading Commission, Agencies and Commissions
The Commodity Futures Trading Commission (CFTC or Commission) is adopting amendments (the Final Rule) to Commission regulations on additional reporting by commodity pool operators (CPOs) and commodity trading advisors and to Form CPO-PQR (also, the form). The Commission is: Eliminating existing Schedules B and C of Form CPO-PQR, except for the Pool Schedule of Investments; amending the information requirements and instructions to request Legal Entity Identifiers (LEIs) for CPOs and their operated pools that have them, and to delete questions regarding pool auditors and marketers; and making certain other changes due to the rescission of Schedules B and C, including the elimination of all existing reporting thresholds. Pursuant to the Final Rule, all reporting CPOs will be required to file the revised Form CPO-PQR (Revised Form CPO-PQR, or the Revised Form) quarterly. The Final Rule also amends Commission regulations to permit reporting CPOs to file NFA Form PQR, a comparable form required by the National Futures Association (NFA), in lieu of filing the Commission's Revised Form. Conversely, Form PF will no longer be accepted in lieu of the Revised Form, though it will remain a Commission form.
Additional First Year Depreciation Deduction
Document Number: 2020-21112
Type: Rule
Date: 2020-11-10
Agency: Internal Revenue Service, Department of Treasury, Department of the Treasury
This document contains final regulations that provide guidance regarding the additional first year depreciation deduction under section 168(k) of the Internal Revenue Code (Code). These final regulations reflect and further clarify the increased deduction and the expansion of qualified property, particularly to certain classes of used property, authorized by the Tax Cuts and Jobs Act. These final regulations generally affect taxpayers who depreciate qualified property acquired and placed in service after September 27, 2017.
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