Page Range | 8133-8387 | |
FR Document |
Page and Subject | |
---|---|
81 FR 8387 - Death of Antonin Scalia | |
81 FR 8379 - Establishment of the Sand to Snow National Monument | |
81 FR 8371 - Establishment of the Mojave Trails National Monument | |
81 FR 8363 - Establishment of the Castle Mountains National Monument | |
81 FR 8198 - Sunshine Act Meeting | |
81 FR 8200 - Sunshine Act Meeting | |
81 FR 8181 - Sunshine Act Notice | |
81 FR 8214 - National Protection and Programs Directorate; Cybersecurity Information Sharing Act of 2015 Interim Guidance Documents-Notice of Availability | |
81 FR 8149 - Reporting of Original Issue Discount on Tax-Exempt Obligations; Basis and Transfer Reporting by Securities Brokers for Debt Instruments and Options | |
81 FR 8252 - Agency Information Collection Activities; Submission for OMB Review; Comment Request; Request for Employment Information | |
81 FR 8357 - Art Advisory Panel of the Commissioner of Internal Revenue | |
81 FR 8251 - Agency Information Collection Activities; Submission for OMB Review; Comment Request; Representative Fee Request | |
81 FR 8254 - National Science Board; Sunshine Act Meetings; Notice | |
81 FR 8180 - Agency Information Collection Activities: Submission for OMB Review; Comment Request | |
81 FR 8173 - Application for Additional Production Authority; The Coleman Company, Inc.; Subzone 119I; (Textile-Based Personal Flotation Devices); Change of Location for Public Hearing | |
81 FR 8179 - Agency Information Collection Activities: Comment Request; Emergency Processing Request | |
81 FR 8261 - Submission for OMB Review; Comments Request | |
81 FR 8256 - Mallinckrodt, LLC | |
81 FR 8173 - Certain Cut-to-Length Carbon Steel Plate From the People's Republic of China: Initiation of Circumvention Inquiry on Antidumping Duty Order | |
81 FR 8258 - Independent Spent Fuel Storage Installation, Maine Yankee Atomic Power Company | |
81 FR 8218 - Notice of Inventory Completion: Thomas Burke Memorial Washington State Museum, University of Washington, Seattle, WA | |
81 FR 8216 - Notice of Intent To Repatriate Cultural Items: Mount Holyoke College Art Museum, South Hadley, MA | |
81 FR 8217 - Notice of Inventory Completion: U.S. Department of Defense, Department of the Navy, Washington, DC | |
81 FR 8219 - Native American Graves Protection and Repatriation Review Committee; Findings and Recommendations Regarding Human Remains and Associated Funerary Objects for The Osage Nation | |
81 FR 8197 - National Environmental Justice Advisory Council | |
81 FR 8323 - Agency Information Collection Activities: Proposed Request and Comment Request | |
81 FR 8200 - Notice of Agreements Filed | |
81 FR 8253 - Maritime Advisory Committee for Occupational Safety and Health (MACOSH) | |
81 FR 8326 - Delegation of Authority 250-1: Further Assignment of Functions Under the Bipartisan Congressional Trade Priorities and Accountability Act of 2015 (the “Act”) to Other Departments and Agencies of the Executive Branch | |
81 FR 8326 - U.S. Advisory Commission on Public Diplomacy; Notice of Meeting | |
81 FR 8184 - Orders Granting Authority To Import and Export Natural Gas, To Import and Export Liquefied Natural Gas, and To Vacate Authorization During January 2016 | |
81 FR 8258 - Atomic Safety and Licensing Board; Before Administrative Judges: Ronald M. Spritzer, Chairman; Nicholas G. Trikouros; Dr. James F. Jackson; in the Matter of Southern Nuclear Operating Company, Inc.; (Vogtle Electric Generating Plant, Units 3 and 4) | |
81 FR 8255 - Advisory Committee on Reactor Safeguards (ACRS); Meeting of the ACRS Subcommittee on Radiation Protection and Nuclear Materials; Notice of Meeting | |
81 FR 8255 - Advisory Committee on Reactor Safeguards (ACRS) Meeting of the ACRS Subcommittee on Plant License Renewal; Notice of Meeting | |
81 FR 8256 - Advisory Committee on Reactor Safeguards (ACRS); Meeting of the ACRS Subcommittee on Reliability and PRA | |
81 FR 8215 - 60-Day Notice of Proposed Information Collection: The Multifamily Project Application and Construction Prior to Initial Endorsement | |
81 FR 8177 - Whaling Provisions; Aboriginal Subsistence Whaling Quotas | |
81 FR 8199 - Information Collection Being Reviewed by the Federal Communications Commission | |
81 FR 8197 - Pick-Sloan Missouri Basin Program-Eastern Division | |
81 FR 8247 - Arvinder Singh, M.D.; Decision and Order | |
81 FR 8221 - Hatem M. Ataya, M.D.; Decision and Order; Introduction and Procedural History | |
81 FR 8246 - Importer of Controlled Substances Registration: Catalent Pharma Solutions, LLC | |
81 FR 8245 - Manufacturer of Controlled Substances Registration: Mallinckrodt, LLC | |
81 FR 8327 - CSX Transportation, Inc.-Discontinuance of Service Exemption-in Harlan County, KY | |
81 FR 8246 - Manufacturer of Controlled Substances Registration: Euticals, Inc. | |
81 FR 8247 - Importer of Controlled Substances Registration: Sigma Aldrich International GMBH-Sigma Aldrich Co. LLC | |
81 FR 8246 - Bulk Manufacturer of Controlled Substances Application: Cedarburg Pharmaceuticals, Inc. | |
81 FR 8213 - Merchant Mariner Medical Advisory Committee | |
81 FR 8326 - Railroad Cost Recovery Procedures-Productivity Adjustment | |
81 FR 8254 - Criteria and Design Features for Inspection of Water-Control Structures Associated With Nuclear Power Plants | |
81 FR 8171 - Television Broadcasting Services; Scottsbluff, Nebraska and Sidney, Nebraska | |
81 FR 8220 - Notice of Receipt of Complaint; Solicitation of Comments Relating to the Public Interest | |
81 FR 8182 - National Assessment Governing Board Quarterly Board Meeting | |
81 FR 8177 - Gulf of Mexico Fishery Management Council; Public Meeting | |
81 FR 8181 - Agency Information Collection Activities; Comment Request; Integrated Postsecondary Education Data System (IPEDS) 2016-2019 | |
81 FR 8178 - Gulf of Mexico Fishery Management Council; Public Meeting | |
81 FR 8251 - Notice of Availability of Funds and Funding Opportunity Announcement for: Summer Jobs and Beyond: Career Pathways for Youth (CPY) | |
81 FR 8193 - Clark Canyon Hydro, LLC; Notice of Application Ready for Environmental Analysis and Soliciting Comments, Recommendations, Terms and Conditions, and Prescriptions | |
81 FR 8194 - Comanche Solar PV, LLC; Supplemental Notice That Initial Market-Based Rate Filing Includes Request for Blanket Section 204 Authorization | |
81 FR 8188 - Idaho Power Company; Notice of Application Accepted for Filing and Soliciting Comments, Motions To Intervene, and Protests | |
81 FR 8171 - Accelerating Reporting Requirements for Class I Railroads | |
81 FR 8146 - Effective Date of Requirement for Premarket Approval for Total Metal-on-Metal Semi-Constrained Hip Joint Systems | |
81 FR 8206 - Agency Information Collection Activities; Submission for Office of Management and Budget Review; Comment Request; Substances Generally Recognized as Safe: Notification Procedure | |
81 FR 8189 - Notice of Commission Staff Attendance | |
81 FR 8262 - Agency Forms Submitted for OMB Review, Request for Comments | |
81 FR 8187 - Axpo U.S. LLC; Supplemental Notice That Initial Market-Based Rate Filing Includes Request for Blanket Section 204 Authorization | |
81 FR 8186 - Smith Creek Hydro, LLC; Supplemental Notice That Initial Market-Based Rate Filing Includes Request for Blanket Section 204 Authorization | |
81 FR 8190 - Voyager Wind I, LLC; Supplemental Notice That Initial Market-Based Rate Filing Includes Request for Blanket Section 204 Authorization | |
81 FR 8196 - Notice of Schedule for Environmental Review of the Leach Xpress and Rayne Xpress Expansion Projects | |
81 FR 8192 - Notice of Schedule for Environmental Review of the White Oak Mainline Expansion Project and System Reliability Project | |
81 FR 8189 - Combined Notice of Filings | |
81 FR 8195 - Combined Notice of Filings #2 | |
81 FR 8193 - Combined Notice of Filings #1 | |
81 FR 8187 - 62SK 8ME LLC; Supplemental Notice That Initial Market-Based Rate Filing Includes Request for Blanket Section 204 Authorization | |
81 FR 8191 - Summer Solar LLC; Supplemental Notice That Initial Market-Based Rate Filing Includes Request for Blanket Section 204 Authorization | |
81 FR 8187 - Conway Corporation; Notice of Filing | |
81 FR 8191 - City of West Memphis, Arkansas; Notice of Filing | |
81 FR 8190 - Transcontinental Gas Pipe Line Company, LLC; Notice of Schedule for Environmental Review of the New York Bay Expansion Project | |
81 FR 8185 - Combined Notice of Filings | |
81 FR 8143 - Airworthiness Directives; B-N Group Ltd. Airplanes | |
81 FR 8327 - Notice of Final Federal Agency Actions on Proposed Highway in California | |
81 FR 8201 - Proposed Data Collection Submitted for Public Comment and Recommendations | |
81 FR 8203 - Agency Forms Undergoing Paperwork Reduction Act Review | |
81 FR 8215 - Endangered Species; Recovery Permit Applications | |
81 FR 8282 - PowerShares Exchange-Traded Self-Indexed Fund Trust, et al.; Notice of Application | |
81 FR 8157 - Airworthiness Directives; The Boeing Company Airplanes | |
81 FR 8180 - Defense Personal Property Program (DP3) | |
81 FR 8359 - Proposed Information Collection (Civilian Health and Medical Program of the Department of Veterans Affairs (CHAMPVA) Benefits-Application, Claim, Other Health Insurance & Potential Liability); Activity: Comment Request | |
81 FR 8358 - Agency Information Collection (Dependents' Request for Change of Program or Place of Training) Activity Under OMB Review | |
81 FR 8359 - Proposed Information Collection-Request for a Certificate of Eligibility VA Form 26-1880 | |
81 FR 8358 - Proposed Information Collection (Report of Subcontracts to Small and Veteran-Owned Business-VA0896a); Activity: Comment Request | |
81 FR 8361 - Agency Information Collection (Loan Analysis) Activity Under OMB Review | |
81 FR 8207 - Request for Nominations on Public Advisory Panels of the Medical Devices Advisory Committee | |
81 FR 8261 - New Postal Product | |
81 FR 8204 - Information Collection; New Funding Formula for the State Councils on Developmental Disabilities (SCDDs) and Protection and Advocacy Systems (P&As) Located in Each State and Territory | |
81 FR 8264 - Joint Industry Plan; Notice of Filing of Amendment No. 3 to the National Market System Plan for the Selection and Reservation of Securities Symbols Submitted by Financial Industry Regulatory Authority, Inc., BATS Exchange, Inc., BOX Options Exchange, LLC, Chicago Board Options Exchange, Incorporated, Chicago Stock Exchange, Inc., EDGA Exchange, Inc., EDGX Exchange, Inc., International Securities Exchange, LLC, NASDAQ OMX BX, Inc., NASDAQ OMX PHLX, Inc., The Nasdaq Stock Market LLC, National Stock Exchange, Inc., New York Stock Exchange, LLC, NYSE MKT, LLC, and NYSE Arca, Inc. | |
81 FR 8308 - Self-Regulatory Organizations; NASDAQ PHLX LLC; Notice of Filing and Immediate Effectiveness of Proposed Rule Change Regarding Rule 505 and Rule 506 | |
81 FR 8178 - Atlantic Highly Migratory Species; Meeting of the Atlantic Highly Migratory Species Advisory Panel | |
81 FR 8313 - Self-Regulatory Organizations; New York Stock Exchange LLC; Notice of Filing and Immediate Effectiveness of Proposed Rule Change to the Co-Location Services Offered by the Exchange To Include a Means for Co-Located Users To Receive the NASDAQ TotalView Ultra Market Data Feed Through a Wireless Connection and Reflect Changes to the Exchange Price List | |
81 FR 8265 - Self-Regulatory Organizations; NYSE Arca, Inc.; Notice of Filing and Immediate Effectiveness of Proposed Rule Change to the Co-Location Services Offered by the Exchange To Include a Means for Co-Located Users To Receive the NASDAQ TotalView Ultra Market Data Feed Through a Wireless Connection and Reflect Changes to the NYSE Arca Equities Schedule of Fees and Charges for Exchange Services and the Options Fee Schedule | |
81 FR 8269 - Self-Regulatory Organizations; NYSE Arca, Inc.; Notice of Filing of Proposed Rule Change To Adopt NYSE Arca Equities Rule 8.900 To Permit Listing and Trading of Managed Portfolio Shares and To Permit Listing and Trading of Shares of Fifteen Issues of the Precidian ETFs Trust | |
81 FR 8319 - Self-Regulatory Organizations; The NASDAQ Stock Market LLC; Notice of Filing and Immediate Effectiveness of Proposed Rule Change To Amend NOM Rules at Chapter XV, Section 2 | |
81 FR 8291 - Self-Regulatory Organizations; NYSE Arca, Inc.; Notice of Filing and Immediate Effectiveness of Proposed Rule Change Modifying the Arca Options Deep Market Data Product | |
81 FR 8310 - Self-Regulatory Organizations; NYSE MKT LLC; Notice of Filing and Immediate Effectiveness of Proposed Rule Change Modifying the Amex Options Deep Market Data Product | |
81 FR 8294 - Self-Regulatory Organizations; The Options Clearing Corporation; Order Setting Aside Action by Delegated Authority, Approving Proposed Rule Change Concerning the Options Clearing Corporation's Capital Plan and Denying Motions | |
81 FR 8316 - Self-Regulatory Organizations; NYSE MKT LLC; Notice of Filing and Immediate Effectiveness of Proposed Rule Change to the Co-location Services Offered by the Exchange To Include a Means for Co-located Users To Receive the NASDAQ TotalView Ultra Market Data Feed Through a Wireless Connection and Reflect Changes to the NYSE MKT Equities Price List and the NYSE Amex Options Fee Schedule | |
81 FR 8184 - Agency Information Collection Activities; Submission to the Office of Management and Budget for Review and Approval; Comment Request; Client Assistance Program (CAP) | |
81 FR 8168 - Drawbridge Operation Regulation; Indian Creek, Miami Beach, FL | |
81 FR 8208 - Agency Information Collection Activities; Submission to OMB for Review and Approval; Public Comment Request | |
81 FR 8204 - Privacy Act of 1974; Report of a New Routine Use for a CMS System of Records | |
81 FR 8209 - National Institute on Alcohol Abuse and Alcoholism; Notice of Closed Meeting | |
81 FR 8210 - National Institute of Environmental Health Sciences; Notice of Closed Meetings | |
81 FR 8209 - National Institute of Mental Health; Notice of Closed Meetings | |
81 FR 8212 - National Institute on Aging, Notice of Closed Meeting | |
81 FR 8210 - National Institute of Dental & Craniofacial Research; Notice of Closed Meeting | |
81 FR 8210 - National Eye Institute; Notice of Closed Meeting | |
81 FR 8212 - National Institute of Allergy and Infectious Diseases; Notice of Closed Meetings | |
81 FR 8211 - Center for Scientific Review; Notice of Closed Meetings | |
81 FR 8133 - Unfair or Deceptive Acts or Practices (Regulation AA) | |
81 FR 8342 - Native American CDFI Assistance Program (NACA Program) FY 2016 Funding Round | |
81 FR 8328 - Community Development Financial Institutions Program (CDFI Program) FY 2016 Funding Round | |
81 FR 8140 - Airworthiness Directives; The Boeing Company Airplanes | |
81 FR 8138 - Airworthiness Directives; The Boeing Company Airplanes | |
81 FR 8134 - Airworthiness Directives; Airbus Airplanes | |
81 FR 8164 - Airworthiness Directives; The Boeing Company Airplanes | |
81 FR 8160 - Airworthiness Directives; Airbus Airplanes | |
81 FR 8166 - Airworthiness Directives; Fokker Services B.V. Airplanes | |
81 FR 8155 - Airworthiness Directives; Airbus Airplanes | |
81 FR 8357 - Notice of Open Public Hearing |
Foreign-Trade Zones Board
International Trade Administration
National Oceanic and Atmospheric Administration
Federal Energy Regulatory Commission
Western Area Power Administration
Centers for Disease Control and Prevention
Centers for Medicare & Medicaid Services
Community Living Administration
Food and Drug Administration
National Institutes of Health
Coast Guard
Fish and Wildlife Service
National Park Service
Drug Enforcement Administration
Employment and Training Administration
Occupational Safety and Health Administration
Federal Aviation Administration
Federal Highway Administration
Community Development Financial Institutions Fund
Internal Revenue Service
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 LISTSERV electronic mailing list, go to http://listserv.access.thefederalregister.org and select Online mailing list archives, FEDREGTOC-L, Join or leave the list (or change settings); then follow the instructions.
Board of Governors of the Federal Reserve System.
Final rule.
The Board of Governors of the Federal Reserve System (Board) is repealing its Regulation AA, which was issued pursuant to its rule writing authority under section 18(f)(1) of the Federal Trade Commission Act (FTC Act or Act). Section 1092(2) of the Dodd-Frank Wall Street Reform and Consumer Protection Act (Dodd-Frank Act) repealed section 18(f)(1) of the FTC Act, thus eliminating the Board's rule writing authority under the Act.
The final rule is effective March 21, 2016.
Mandie K. Aubrey, Counsel, Division of Consumer and Community Affairs, at (202) 452-3667, Board of Governors of the Federal Reserve System, 20th and C Streets NW., Washington, DC 20551. For users of Telecommunications Device for the Deaf (TDD) only, contact (202) 263-4869.
The FTC Act directs the Federal Trade Commission (FTC) to promulgate rules to define and prevent unfair or deceptive acts or practices for persons other than banks, savings and loans, and Federal credit unions.
Prior to amendments to the FTC Act made by the Dodd-Frank Act in 2010, section 18(f)(1) of the FTC Act required the Board to promulgate rules applicable to banks that were “substantially similar” to these FTC rules, with some exceptions.
Pursuant to its rule writing authority in section 18(f)(1) of the FTC Act, the Board issued Regulation AA, including the Board's credit practices rule, which was adopted in 1985.
The Board's credit practices rule in Regulation AA prohibited banks from using certain remedies to enforce consumer credit obligations and from including these remedies in their consumer credit contracts. The rule also prohibited banks from: (1) Obligating a co-signer on the debt unless the co-signer previously received a clear and conspicuous written notice explaining the nature of the co-signer's obligations and liabilities under the contract; and (2) imposing a late fee when a consumer makes a full loan payment on time or within the grace period, solely because the consumer did not pay a previous late fee imposed on an earlier installment (the “pyramiding” of late fees).
In addition, Regulation AA contained a provision that informed consumers how to file a complaint regarding a state member bank and explained the Board's procedure for responding to such complaints.
The Dodd-Frank Act
In August 2014, the Board published a proposal to repeal Regulation AA (Proposed Rule).
Fourteen commenters responded to the proposed repeal of Regulation AA. Three individual commenters stated that Regulation AA was a necessary and helpful regulation; two of these commenters stated that the Board's reasons for repealing the regulation were unclear. A comment letter received from seven consumer advocate organizations acknowledged that the Board's repeal of Regulation AA was required by the Dodd-Frank Act. In their letter, these commenters also provided recommendations to the Bureau regarding acts or practices that the Bureau now has to authority to regulate if it finds they are unfair or deceptive.
Eight commenters addressed the interagency guidance that was issued simultaneously with the proposed repeal of Regulation AA. One individual commenter believed the guidance would discourage banks from engaging in unfair or deceptive acts or practices, but seven consumer advocate commenters recommended strengthening the guidance language. The consumer advocate commenters also recommended that the Board issue additional guidance regarding other acts or practices that the commenters believe should be declared unfair or deceptive acts or practices.
The Board is finalizing the repeal of Regulation AA as proposed. As the Board discussed in the Proposed Rule, the Dodd-Frank Act eliminated the Board's rule writing authority under the FTC Act, which nullified the regulation. The Board will continue to monitor developments with respect to unfair or deceptive acts or practices and assess whether to issue additional supervisory guidance.
The repeal of Regulation AA also eliminates Subpart A of the regulation, which generally describes the internal procedures used by the Board in handling consumer complaints. The Board did not receive comment on the removal of these internal procedures from the Code of Federal Regulations. Information about how the Board processes consumer complaints is provided on the Board's public Web site.
The Regulatory Flexibility Act
1.
2.
3.
4.
5.
In accordance with the Paperwork Reduction Act (PRA) of 1995 (44 U.S.C. 3506; 5 CFR 1320 Appendix A.1), the Board reviewed the rule under the authority delegated to the Federal Reserve by the Office of Management and Budget (OMB). The final rule contains no requirements subject to the PRA.
Banks, Banking, Consumer protection, Credit, Federal Reserve System, Finance.
For the reasons set forth in the preamble, and under the authority of section 1092(2) of Public Law 111-203, 124 Stat. 1376 (Jul. 21, 2010), the Board amends 12 CFR chapter II by removing part 227.
Federal Aviation Administration (FAA), Department of Transportation (DOT).
Final rule; request for comments.
We are superseding Airworthiness Directive (AD) 2015-26-02 for all Airbus Model A330-200, A330-200 Freighter, and A330-300 series airplanes; and Airbus Model A340-200, A340-300, A340-500, and A340-600 series airplanes. AD 2015-26-02 required, for certain airplanes, identification of the part number, serial number, and standard of the ram air turbine (RAT) pump, RAT module, RAT actuator, and RAT lower gearbox assembly; replacement of the balance
This AD becomes effective March 4, 2016.
The Director of the Federal Register approved the incorporation by reference of certain publications listed in this AD as of February 2, 2016 (80 FR 81174, December 29, 2015).
We must receive comments on this AD by April 4, 2016.
You may send comments, using the procedures found in 14 CFR 11.43 and 11.45, by any of the following methods:
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•
•
•
For Airbus service information identified in this final rule, contact Airbus SAS, Airworthiness Office—EAL, 1 Rond Point Maurice Bellonte, 31707 Blagnac Cedex, France; telephone +33 5 61 93 36 96; fax +33 5 61 93 45 80; email
For Hamilton Sundstrand service information identified in this final rule, contact Hamilton Sundstrand, Technical Publications, Mail Stop 302-9, 4747 Harrison Avenue, P.O. Box 7002, Rockford, IL 61125-7002; telephone 860-654-3575; fax 860-998-4564; email
You may view this referenced service information at the FAA, Transport Airplane Directorate, 1601 Lind Avenue SW., Renton, WA. For information on the availability of this material at the FAA, call 425-227-1221. It is also available on the Internet at
You may examine the AD docket on the Internet at
Vladimir Ulyanov, Aerospace Engineer, International Branch, ANM-116, Transport Airplane Directorate, FAA, 1601 Lind Avenue SW., Renton, WA 98057-3356; telephone 425-227-1138; fax 425-227-1149.
On December 9, 2015, we issued AD 2015-26-02, Amendment 39-18350 (80 FR 81174, December 29, 2015) (“AD 2015-26-02”). AD 2015-26-02 applied to all Airbus Model A330-200, A330-200 Freighter, and A330-300 series airplanes; and Airbus Model A340-200, A340-300, A340-500, and A340-600 series airplanes. AD 2015-26-02 was prompted by a report indicating that, during a production flight test, the RAT did not pressurize the green hydraulic system. AD 2015-26-02 required for certain airplanes, identification of the part number, serial number, and standard of the RAT pump, RAT module, RAT actuator, and RAT lower gearbox assembly; replacement of the balance weight screw, modification of the actuator coil spring, modification of the actuator, an inspection of the anti-stall valve for correct installation in the RAT pump housing; and corrective actions if necessary. For certain other airplanes, AD 2015-26-02 required re-identification or replacement of the RAT module. We issued AD 2015-26-02 to prevent loss of the impeller function and RAT pump pressurization capability, which, if preceded by a total engine flame-out, could result in loss of control of the airplane.
Since we issued AD 2015-26-02, we received a report of a typographical error in the regulatory text of AD 2015-26-02. Paragraph (m) of AD 2015-26-02 inadvertently referred to paragraph (n) and should have referred to paragraph (o), “Parts Installation Prohibition.”
The European Aviation Safety Agency (EASA), which is the Technical Agent for the Member States of the European Union, has issued EASA Airworthiness Directive 2013-0274, dated November 15, 2013 (referred to after this as the Mandatory Continuing Airworthiness Information, or “the MCAI”), to correct an unsafe condition for all Airbus Model A330-200, A330-200 Freighter, and A330-300 series airplanes; and Airbus Model A340-200, A340-300, A340-500, and A340-600 series airplanes. The MCAI states:
During a production flight test of an A330-300 aeroplane, the Ram Air Turbine (RAT) did not pressurize the green hydraulic system. Investigation revealed that the impeller drive (hex) shaft had a reduced length of engagement with the pump drive shaft. This caused the impeller drive shaft to disengage from the pump and disconnect the impeller. It was determined that the disconnection was the result of internal hex dimensions on the pump impeller shaft, which had been changed in a manufacturing drawing. From the investigation analysis, it was possible to identify a list of affected parts.
This condition, if not detected and corrected, could lead to the loss of impeller function and RAT pump pressurization capability, possibly resulting, in case of total engine flame out, to the loss of control of the aeroplane.
To address this unsafe condition, a new design RAT pump shaft has been developed with a decreased hexagonal shaft housing depth, which increases the hexagonal drive shaft engagement in the impeller shaft to carry the impeller torque. Airbus issued Service Bulletin (SB) A330-29-3122, SB A340-29-4093 and SB A340-29-5021 to provide instructions for in-service replacement of the affected RAT hydraulic pumps, or re-identification of the RAT pump and complete RAT module, as applicable.
For the reasons described above, this [EASA] AD requires identification and replacement [modification] or re-identification of all affected RAT hydraulic pumps on A330 and A340-200/300 aeroplanes, and replacement [modification] of all affected RAT modules on A340-500/-600 aeroplanes.
For affected pumps, the required actions also include concurrent actions, as applicable, including replacement of the balance weight screw, modification of the actuator coil spring, modification of the actuator, an inspection of the anti-stall valve for correct installation in the RAT pump housing and re-installation if necessary. For affected pumps, corrective actions include replacement of the RAT hydraulic pump, and re-identification of the part number of the
Airbus has issued the following service information:
• Airbus Service Bulletin A330-29-3122, dated October 25, 2012.
• Airbus Service Bulletin A340-29-4093, dated October 25, 2012.
This service information describes procedures for identifying the part number, serial number, and standard of the RAT pump, RAT module, RAT actuator, and RAT lower gearbox assembly; replacing the balance weight screw, modifying the actuator coil spring, modifying the actuator, and doing an inspection of the anti-stall valve for correct installation; and re-identifying the part numbers of the RAT hydraulic pump and RAT module.
Airbus also issued Service Bulletin A330-29-3126, dated June 12, 2014; and Service Bulletin A340-29-4097, dated June 12, 2014, which describe procedures for identifying the part number and serial number of the RAT actuator; modifying the RAT actuators; and re-identifying the part numbers of the RAT module.
In addition, Airbus issued Service Bulletin A340-29-5021, dated October 2, 2012; and Service Bulletin A340-29-5025, dated June 16, 2014, which describe procedures for replacing (modifying) the RAT module.
Hamilton Sundstrand has issued Service Bulletin ERPS06M-29-19, dated August 6, 2012, which identifies the serial numbers of the suspect hydraulic pump.
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
This product has been approved by the aviation authority of another country, and is approved for operation in the United States. Pursuant to our bilateral agreement with the State of Design Authority, we have been notified of the unsafe condition described in the MCAI and service information referenced above. We are issuing this AD because we evaluated all pertinent information and determined the unsafe condition exists and is likely to exist or develop on other products of these same type designs.
We are superseding AD 2015-26-02 to correct a typographical error in the regulatory text. No other changes have been made to AD 2015-26-02. Therefore, we determined that notice and opportunity for prior public comment are unnecessary.
This AD is a final rule that involves requirements affecting flight safety, and we did not precede it by notice and opportunity for public comment. We invite you to send any written relevant data, views, or arguments about this AD. Send your comments to an address listed under the
We will post all comments we receive, without change, to
We estimate that this AD affects 66 airplanes of U.S. registry.
We also estimate that it will take about 14 work-hours per product to comply with the basic requirements of this AD. The average labor rate is $85 per work-hour. Based on these figures, we estimate the cost of this AD on U.S. operators to be $78,540, or $1,190 per product.
In addition, we estimate that any necessary follow-on actions will take about 18 work-hours and require parts costing up to $427,301, for a cost of $428,831 per product. We have no way of determining the number of aircraft that might need this action.
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.
We determined that 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 the 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.
Air transportation, Aircraft, Aviation safety, Incorporation by reference, Safety.
Accordingly, under the authority delegated to me by the Administrator, the FAA amends 14 CFR part 39 as follows:
49 U.S.C. 106(g), 40113, 44701.
This AD becomes effective March 4, 2016.
(1) This AD replaces AD 2015-26-02, Amendment 39-18350 (80 FR 81174, December 29, 2015).
(2) This AD affects AD 2012-21-19, Amendment 39-17235 (77 FR 65812, October 31, 2012); and AD 2012-21-20, Amendment 39-17236 (77 FR 65799, October 31, 2012).
This AD applies to all Airbus airplanes, certificated in any category, identified in paragraphs (c)(1) and (c)(2) of this AD, all manufacturer serial numbers.
(1) Model A330-201, -202, -203, -223, -223F, -243, -243F, -301, -302, -303, -321, -322, -323, -341, -342, and -343 airplanes.
(2) Model A340-211, -212, -213, -311, -312, -313, -541, and -642 airplanes.
Air Transport Association (ATA) of America Code 29, Hydraulic Power.
This AD was prompted by a report indicating that, during a production flight test, the ram air turbine (RAT) did not pressurize the green hydraulic system. We are issuing this AD to prevent loss of the impeller function and RAT pump pressurization capability, which, if preceded by a total engine flame-out, could result in loss of control of the airplane.
Comply with this AD within the compliance times specified, unless already done.
For Airbus Model A330-201, -202, -203, -223, -223F, -243, -243F, -301, -302, -303, -321, -322, -323, -341, -342, and -343 airplanes; and Model A340-211, -212, -213, -311, -312, and -313 airplanes: Except as provided by paragraph (i) of this AD, within 36 months after the effective date of this AD, identify the part number, serial number, and standard (through the mod-dots) of the RAT pump, RAT module, RAT actuator, and RAT lower gearbox assembly, in accordance with the Accomplishment Instructions of the applicable Airbus service information specified in paragraphs (g)(1) and (g)(2) of this AD. A review of airplane maintenance records is acceptable in lieu of this identification if the part number, serial number, and standard can be conclusively determined from that review.
(1) For Airbus Model A330-201, -202, -203, -223, -223F, -243, -243F, -301, -302, -303, -321, -322, -323, -341, -342, and -343 airplanes: Airbus Service Bulletin A330-29-3122, dated October 25, 2012.
(2) For Airbus Model A340-211, -212, -213, -311, -312, and -313 airplanes: Airbus Service Bulletin A340-29-4093, dated October 25, 2012.
If the serial number of the RAT hydraulic pump is included in table 7, “Suspect Hydraulic Pump Serial Numbers,” of Hamilton Sundstrand Service Bulletin ERPS06M-29-19, dated August 6, 2012: Within 36 months after the effective date of this AD, do all applicable corrective actions, in accordance with the Accomplishment Instructions of the applicable Airbus service information specified in paragraphs (g)(1) and (g)(2) of this AD. Prior to or concurrently with doing the corrective actions required by this paragraph, do the actions specified in paragraphs (h)(1) through (h)(4) of this AD, in accordance with the Accomplishment Instructions of Airbus Service Bulletin A330-29-3122, dated October 25, 2012 (for Model A330-200, -200 Freighter, and -300 series airplanes); or Airbus Service Bulletin A340-29-4093, dated October 25, 2012 (for Airbus Model A340-211, -212, -213, -311, -312, and -313 airplanes).
(1) Replace the balance weight screw.
(2) Modify the actuator coil spring.
(3) Modify the actuator.
(4) Do a general visual inspection of the anti-stall valve for correct installation in the RAT pump housing, and if any incorrect installation is found, before further flight, correctly install the anti-stall valve.
Airbus Service Bulletin A330-29-3122, dated October 25, 2012 (for Model A330-200, -200 Freighter, and -300 series airplanes), refers to Hamilton Sundstrand Service Bulletin “EPRPS06M-29-13” as an additional source of guidance for doing certain actions required by paragraph (h) of this AD. The first “P” in the citation should have been omitted; the correct reference is to Hamilton Sundstrand Service Bulletin “ERPS06M-29-13.”
If the serial number of the RAT hydraulic pump is not included in table 7, “Suspect Hydraulic Pump Serial Numbers,” of Hamilton Sundstrand Service Bulletin ERPS06M-29-19, dated August 6, 2012: Within 36 months after the effective date of this AD, re-identify the part numbers of the RAT hydraulic pump and RAT module, in accordance with the Accomplishment Instructions of the applicable Airbus service information specified in paragraphs (g)(1) and (g)(2) of this AD.
Accomplishment of the actions required by paragraphs (g), (h), and (j) of this AD, in accordance with the Accomplishment Instructions of Airbus Service Bulletin A330-29-3126, dated June 12, 2014; or Airbus Service Bulletin A340-29-4097, dated June 12, 2014, as applicable, constitutes compliance with the requirements of paragraphs (g), (h), and (j) of this AD.
For Airbus Model A340-541 and -642 airplanes having RAT module part number (P/N) 772722D, 772722E, 772722F, or 772722G: Within 36 months after the effective date of this AD, replace (modify) the RAT module, in accordance with the Accomplishment Instructions of Airbus Service Bulletin A340-29-5021, dated October 2, 2012. As an option, accomplishment of the RAT module replacement (modification), in accordance with the Accomplishment Instructions of Airbus Service Bulletin A340-29-5025, dated June 16, 2014, constitutes compliance with the requirement of this paragraph.
The actions required by paragraphs (g), (h), and (j) of this AD are not required for airplanes on which Airbus Modification 202537 was embodied in production, provided it can be determined that, since the airplane's first flight, no RAT hydraulic pump or RAT module having a part number identified in paragraph (o) of this AD is installed on that airplane.
(1) For Airbus Model A330-201, -202, -203, -223, -223F, -243, -243F, -301, -302, -303, -321, -322, -323, -341, -342, and -343 airplanes; and Model A340-211, -212, -213, -311, -312, and -313 airplanes: Accomplishment of the actions required by paragraphs (g), (h), and (j) of this AD constitutes compliance with the requirements of paragraphs (g)(1) and (g)(2) of AD 2012-21-19, Amendment 39-17235 (77 FR 65812, October 31, 2012); and paragraphs (g)(1) and (g)(2) of AD 2012-21-20, Amendment 39-17236 (77 FR 65799, October 31, 2012).
(2) For Airbus Model A340-541 and -642 airplanes: Accomplishment of the actions required by paragraph (l) of this AD constitutes compliance with the requirements of paragraphs (h)(1) and (h)(2) of AD 2012-21-20, Amendment 39-17236 (77 FR 65799, October 31, 2012).
(1) For Airbus Model A330-201, -202, -203, -223, -223F, -243, -243F, -301, -302, -303, -321, -322, -323, -341, -342, and -343 airplanes; and A340-211, -212, -213, -311, -312, and -313 airplanes: After modification of the RAT module as required by paragraph (h) of this AD, no person may install any complete RAT module having a part number identified in paragraph (o)(1)(i) of this AD, or any RAT hydraulic pump having the part number identified in paragraph (o)(1)(ii) of this AD, on any airplane.
(i) RAT module P/N 766351, 768084, 770379, 770952, 770952A, 770952B, 1702934, 1702934A, or 1702934B.
(ii) RAT hydraulic pump P/N 5909522 (Parker P/N 4207902).
(2) For Airbus Model A340-541 and -642 airplanes: After modification of the RAT module as required by paragraph (l) of this AD, no person may install any complete RAT module having P/N 772722D, 772722E, 772722F, or 772722G, on any airplane.
The following provisions also apply to this AD:
(1)
(2)
Refer to Mandatory Continuing Airworthiness Information (MCAI) EASA Airworthiness Directive 2013-0274, dated November 15, 2013, for related information. This MCAI may be found in the AD docket on the Internet at
(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 this AD specifies otherwise.
(3) The following service information was approved for IBR on February 2, 2016 (80 FR 81174, December 29, 2015).
(i) Airbus Service Bulletin A330-29-3122, dated October 25, 2012.
(ii) Airbus Service Bulletin A330-29-3126, dated June 12, 2014.
(iii) Airbus Service Bulletin A340-29-4093, dated October 25, 2012.
(iv) Airbus Service Bulletin A340-29-4097, dated June 12, 2014.
(v) Airbus Service Bulletin A340-29-5021, dated October 2, 2012.
(vi) Airbus Service Bulletin A340-29-5025, dated June 16, 2014.
(vii) Hamilton Sundstrand Service Bulletin ERPS06M-29-19, dated August 6, 2012.
(4) For Airbus service information identified in this AD, contact Airbus SAS, Airworthiness Office—EAL, 1 Rond Point Maurice Bellonte, 31707 Blagnac Cedex, France; telephone +33 5 61 93 36 96; fax +33 5 61 93 45 80; email
(5) For Hamilton Sundstrand service information identified in this AD, contact Hamilton Sundstrand, Technical Publications, Mail Stop 302-9, 4747 Harrison Avenue, P.O. Box 7002, Rockford, IL 61125-7002; telephone 860-654-3575; fax 860-998-4564; email
(6) You may view this service information at the FAA, Transport Airplane Directorate, 1601 Lind Avenue SW., Renton, WA. For information on the availability of this material at the FAA, call 425-227-1221.
(7) 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:
Federal Aviation Administration (FAA), DOT.
Final rule.
We are adopting a new airworthiness directive (AD) for all The Boeing Company Model 747-400F series airplanes. This AD was prompted by an analysis of the production methods used to increase fatigue resistance of the upper closure fittings at the nose cargo door portal's C-3 frame, which showed that cracking could start too early to be caught in a timely manner by the inspection or maintenance program. This AD requires inspections of the upper closure fitting and connected strap and doubler at the nose cargo door portal for cracking, and related investigative and corrective actions if necessary. We are issuing this AD to detect and correct such cracking, which could result in sudden decompression and loss of the airplane's structural integrity.
This AD is effective March 24, 2016.
The Director of the Federal Register approved the incorporation by reference of a certain publication listed in this AD as of March 24, 2016.
For service information identified in this final rule, contact Boeing Commercial Airplanes, Attention: Data & Services Management, P.O. Box 3707, MC 2H-65, Seattle, WA 98124-2207; telephone 206-544-5000, extension 1; fax 206-766-5680; Internet
You may examine the AD docket on the Internet at
Bill Ashforth, Aerospace Engineer, Airframe Branch, ANM-120S, FAA, Seattle Aircraft Certification Office (ACO), 1601 Lind Avenue SW., Renton, WA 98057-3356; phone: 425-917-6432; fax: 425-917-6590; email:
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 747-400F series airplanes. The NPRM published in the
We gave the public the opportunity to participate in developing this AD. We considered the comment received. Boeing supported the NPRM.
We reviewed the relevant data, considered the comment received, and determined that air safety and the public interest require adopting this AD as proposed except for minor editorial changes. We have determined that these minor changes:
• Are consistent with the intent that was proposed in the NPRM for correcting the unsafe condition; and
• Do not add any additional burden upon the public than was already proposed in the NPRM.
We reviewed Boeing Alert Service Bulletin 747-53A2880, dated December 3, 2014. This service information describes procedures for a detailed inspection of the upper closure fitting and connected strap and doubler, a surface high frequency eddy current (HFEC) inspection of the upper closure fitting for cracking, and related investigative and corrective actions. 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
We estimate that this AD affects 38 airplanes of U.S. registry.
We estimate the following costs to comply with this AD:
We estimate the following costs to do any necessary repairs or replacements that would be required based on the results of the inspection. Parts costs could be up to $42,930 per airplane. We have no way of determining the number of work hours (because the type of repair will vary depending on findings) or the number of aircraft that might need the repairs or replacements.
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 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.
Air transportation, Aircraft, Aviation safety, Incorporation by reference, Safety.
Accordingly, under the authority delegated to me by the Administrator, the FAA amends 14 CFR part 39 as follows:
49 U.S.C. 106(g), 40113, 44701.
This AD is effective March 24, 2016.
None.
This AD applies to all The Boeing Company Model 747-400F series airplanes, certificated in any category, as identified in paragraph 1.A., “Effectivity,” of Boeing Alert Service Bulletin 747-53A2880, dated December 3, 2014.
Air Transport Association (ATA) of America Code 53, Fuselage.
This AD was prompted by a report that an analysis of the production methods used to increase fatigue resistance of the upper closure fittings at the nose cargo door portal's C-3 frame showed that cracking could still start too early to be caught in a timely
Comply with this AD within the compliance times specified, unless already done.
Except as required by paragraph (h) of this AD: At the applicable time specified in paragraph 1.E., “Compliance,” of Boeing Alert Service Bulletin 747-53A2880, dated December 3, 2014, do a detailed inspection of the upper closure fitting, strap, and doubler and a surface high frequency eddy current (HFEC) inspection of the upper closure fitting at the nose cargo door portal for cracking, and do all applicable related investigative and corrective actions, in accordance with the Accomplishment Instructions of Boeing Alert Service Bulletin 747-53A2880, dated December 3, 2014. Repeat the inspections at the time specified in paragraph 1.E., “Compliance,” of Boeing Alert Service Bulletin 747-53A2880, dated December 3, 2014. Do the applicable related investigative and corrective actions at the times specified in paragraph 1.E., “Compliance,” of Boeing Alert Service Bulletin 747-53A2880, dated December 3, 2014.
(1) Where paragraph 1.E., “Compliance,” of Boeing Alert Service Bulletin 747-53A2880, dated December 3, 2014, refers to a compliance time “after the original issue date of this service bulletin,” this AD requires compliance within the specific compliance time after the effective date of this AD.
(2) If any crack is found during any inspection required by this AD, and Boeing Alert Service Bulletin 747-53A2880, dated December 3, 2014, specifies to contact Boeing for appropriate action: Before further flight, repair the cracking using a method approved in accordance with the procedures specified in paragraph (i) of this AD.
(1) The Manager, Seattle Aircraft Certification Office (ACO), 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 ACO, send it to the attention of the person identified in paragraph (j)(1) of this AD. Information may be emailed to:
(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, to make those findings. For a repair method 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) Except as required by paragraph (h)(2) of this AD: For service information that contains steps that are labeled as Required for Compliance (RC), the provisions of paragraphs (i)(4)(i) and (i)(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. 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.
For more information about this AD, contact Bill Ashforth, Aerospace Engineer, Airframe Branch, ANM-120S, FAA, Seattle ACO, 1601 Lind Avenue SW., Renton, WA 98057-3356; phone: 425-917-6432; fax: 425-917-6590; email:
(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 Alert Service Bulletin 747-53A2880, dated December 3, 2014.
(ii) Reserved.
(3) For service information identified in this AD, contact Boeing Commercial Airplanes, Attention: Data & Services Management, P.O. Box 3707, MC 2H-65, Seattle, WA 98124-2207; telephone 206-544-5000, extension 1; fax 206-766-5680; Internet
(4) You may view this service information FAA, Transport Airplane Directorate, 1601 Lind Avenue SW., Renton, WA. For information on the availability of this material at the FAA, call 425-227-1221.
(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:
Federal Aviation Administration (FAA), DOT.
Final rule.
We are superseding Airworthiness Directive (AD) 2010-26-10, which applied to certain The Boeing Company Model 747-200C, -200F, -400, -400D, and -400F series airplanes. AD 2010-26-10 required repetitive inspections for cracking of the lap joints, modification of certain lap joints, and certain post-repair inspections of the lap joints. This new AD adds new repetitive post-modification inspections for cracking in the lap joints, and repair if necessary. This AD was prompted by an evaluation by the design approval holder (DAH) which indicated that certain lap joints are subject to widespread fatigue damage (WFD). We are issuing this AD to detect and correct fatigue cracking in certain lap joints, which could result in rapid depressurization and consequent reduced structural integrity of the airplane.
This AD is effective March 24, 2016.
The Director of the Federal Register approved the incorporation by reference of a certain publication listed in this AD as of March 24, 2016.
For service information identified in this final rule, contact Boeing Commercial Airplanes, Attention: Data & Services Management, P.O. Box 3707, MC 2H-65, Seattle, WA 98124-2207; telephone 206-544-5000, extension 1; fax 206-766-5680; Internet
You may examine the AD docket on the Internet at
Nathan Weigand, Aerospace Engineer, Airframe Branch, ANM-120S, FAA, Seattle Aircraft Certification Office, 1601 Lind Avenue SW., Renton, WA 98057-3356; phone: 425-917-6428; fax: 425-917-6590; email:
We issued a notice of proposed rulemaking (NPRM) to amend 14 CFR part 39 to supersede AD 2010-26-10, Amendment 39-16549 (75 FR 81427, December 28, 2010). AD 2010-26-10 applied to certain The Boeing Company Model 747-200C, -200F, -400, -400D, and -400F series airplanes. The NPRM published in the
We gave the public the opportunity to participate in developing this AD. The following presents the comments received on the NPRM (80 FR 39394, July 9, 2015) and the FAA's response to each comment. United Airlines concurred with the NPRM.
Boeing asked that we correct the reference in the “Related Service Information under 1 CFR part 51” from “. . . sections 41, 42, and 43” to “. . . sections 41, 42, and 46.” Boeing stated that section 43 should be section 46, and noted that this is a typographical error.
We agree with the commenter's request for the reason provided. We have corrected this typographical error in “Related Service Information under 1 CFR part 51” accordingly.
Boeing asked that we clarify paragraph (i)(1) of the proposed AD (80 FR 39394, July 9, 2015) by including “per Table 7” in that paragraph. Boeing also asked that we clarify paragraph (i)(3) of the proposed AD by including “per Table 10” in that paragraph.
We agree that clarification is necessary but we do not agree to change paragraphs (i)(1) and (i)(3) of this AD. Paragraph (i) of this AD specifies doing the applicable inspections in paragraphs (i)(1), (i)(2), or (i)(3) of this AD, in accordance with the Accomplishment Instructions of the referenced service information; and repeating the applicable inspections at the applicable times specified in Tables 7, 8, 9, and 10 of paragraph 1.E., “Compliance,” of Boeing Alert Service Bulletin 747-53A2499, Revision 3, dated July 15, 2014. In each of these tables the applicable groups are identified and match the groups identified in paragraphs (i)(1), (i)(2), and (i)(3) of this AD. We refer to the tables in paragraph 1.E., “Compliance,” of service information for the applicable compliance times and not for how to accomplish the required actions. Therefore, we have not changed this AD in this regard.
We reviewed the relevant data, considered the comments received, and determined that air safety and the public interest require adopting this AD as proposed, with minor editorial changes. We have determined that these minor changes:
• Are consistent with the intent that was proposed in the NPRM (80 FR 39394, July 9, 2015) for correcting the unsafe condition; and
• Do not add any additional burden upon the public than was already proposed in the NPRM (80 FR 39394, July 9, 2015).
We reviewed Boeing Alert Service Bulletin 747-53A2499, Revision 3, dated July 15, 2014. The service information describes procedures for body skin lap joint inspections and modifications in sections 41, 42, and 46. 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
We estimate that this AD affects 120 airplanes of U.S. registry.
We estimate the following costs to comply with this AD:
We have received no definitive data that would enable us to provide a cost estimate for the on-condition actions specified in this AD.
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.
We have determined that 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.
Air transportation, Aircraft, Aviation safety, Incorporation by reference, Safety.
Accordingly, under the authority delegated to me by the Administrator, the FAA amends 14 CFR part 39 as follows:
49 U.S.C. 106(g), 40113, 44701.
This AD is effective March 24, 2016.
This AD replaces AD 2010-26-10, Amendment 39-16549 (75 FR 81427, December 28, 2010).
This AD applies to The Boeing Company Model 747-200C, -200F, -400, -400D, and -400F series airplanes; certificated in any category; as identified in Boeing Alert Service Bulletin 747-53A2499, Revision 3, dated July 15, 2014.
Air Transport Association (ATA) of America Code 53, Fuselage.
This AD was prompted by an evaluation by the design approval holder indicating that certain lap joints are subject to widespread fatigue damage. We are issuing this AD to detect and correct fatigue cracking in certain lap joints, which could result in rapid depressurization and consequent reduced structural integrity of the airplane.
Comply with this AD within the compliance times specified, unless already done.
At the applicable time specified in Table 1 and Table 3 of paragraph 1.E., “Compliance,” of Boeing Alert Service Bulletin 747-53A2499, Revision 3, dated July 15, 2014, except as required by paragraph (j)(1) of this AD: Do eddy current inspections for cracks in the skin of the lap joints, and do all applicable repairs, in accordance with the Accomplishment Instructions of Boeing Alert Service Bulletin 747-53A2499, Revision 3, dated July 15, 2014, except as required by paragraph (j)(2) of this AD. Do all applicable repairs before further flight. Repeat the applicable inspections thereafter at intervals not to exceed those specified in Table 1 and Table 3 of paragraph 1.E., “Compliance,” of Boeing Alert Service Bulletin 747-53A2499, Revision 3, dated July 15, 2014.
At the applicable time specified in Tables 2, 4, 5, and 6 of paragraph 1.E., “Compliance,” of Boeing Alert Service Bulletin 747-53A2499, Revision 3, dated July 15, 2014, except as required by paragraph (j)(1) of this AD: Modify the applicable lap joints, in accordance with the Accomplishment Instructions of Boeing Alert Service Bulletin 747-53A2499, Revision 3, dated July 15, 2014, except as required by paragraph (j)(2) of this AD. Accomplishment of the modification required by this paragraph terminates the repetitive inspections required by paragraph (g) of this AD for the length of the modified lap joint.
At the applicable time specified in Tables 7, 8, 9, and 10 of paragraph 1.E., “Compliance,” of Boeing Alert Service Bulletin 747-53A2499, Revision 3, dated July 15, 2014, except as required by paragraph (j)(1) of this AD: Do the applicable inspections specified in paragraph (i)(1), (i)(2), or (i)(3) of this AD, in accordance with the Accomplishment Instructions of Boeing Alert Service Bulletin 747-53A2499, Revision 3, dated July 15, 2014. Repeat the applicable inspections thereafter at the applicable times specified in Tables 7, 8, 9, and 10 of paragraph 1.E, “Compliance,” of Boeing Alert Service Bulletin 747-53A2499, Revision 3, dated July 15, 2014. If any crack is found during any inspection, repair before further flight using a method approved in accordance with the procedures specified in paragraph (l) of this AD.
(1) For airplanes identified as Groups 2 through 5 and 8 through 10 in Boeing Alert Service Bulletin 747-53A2499, Revision 3, dated July 15, 2014: Internal detailed and surface high frequency eddy current (HFEC) inspections for any crack in the skin or internal doubler.
(2) For airplanes identified as Groups 6, 11, and 19 in Boeing Alert Service Bulletin 747-53A2499, Revision 3, dated July 15, 2014: External detailed and low frequency eddy current inspections of the upper and lower skin panels for cracking, external detailed and HFEC inspections of the doubler for cracking, and internal detailed and HFEC inspections of the upper and lower skin panels for cracking (for airplanes with a stringer 6 lap joint modification installed between STA 340 and STA 400 as specified in Boeing Service Bulletin 747-53-2272); or internal detailed and surface HFEC inspections for any crack in the skin or internal doubler (for airplanes with lap joints modified as specified in Boeing Alert Service Bulletin 747-53A2499.)
(3) For airplanes identified as Groups 1, 7, and 12 through 18 in Boeing Alert Service Bulletin 747-53A2499, Revision 3, dated July 15, 2014: Internal detailed and surface HFEC inspections for any crack in the skin or internal doubler.
(1) Where Boeing Alert Service Bulletin 747-53A2499, Revision 3, dated July 15, 2014, specifies a compliance time “after the Revision 3 date of this service bulletin,” this AD requires compliance within the specified
(2) Where Boeing Alert Service Bulletin 747-53A2499, Revision 3, dated July 15, 2014, specifies to contact Boeing for repair instructions: Before further flight, repair using a method approved in accordance with the procedures specified in paragraph (l) of this AD.
Actions done before the effective date of this AD using the service information identified in paragraph (k)(1) or (k)(2) of this AD are acceptable for compliance with the corresponding requirements of paragraphs (g) and (h) of this AD.
(1) Boeing Alert Service Bulletin 747-53A2499, Revision 1, dated October 30, 2008, which is not incorporated by reference in this AD.
(2) Boeing Alert Service Bulletin 747-53A2499, Revision 2, dated August 12, 2010, which was incorporated by reference in AD 2010-26-10, Amendment 39-16549 (75 FR 81427, December 28, 2010).
(1) The Manager, Seattle Aircraft Certification Office (ACO), 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 ACO, send it to the attention of the person identified in paragraph (m)(1) of this AD. Information may be emailed to:
(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, 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) AMOCs approved for AD 2010-26-10, Amendment 39-16549 (75 FR 81427, December 28, 2010), are approved as AMOCs for the corresponding provisions of paragraphs (g) and (h) this AD.
(1) For more information about this AD, contact Nathan Weigand, Aerospace Engineer, Airframe Branch, ANM-120S, FAA, Seattle Aircraft Certification Office, 1601 Lind Avenue SW., Renton, WA 98057-3356; phone: 425-917-6428; fax: 425-917-6590; email:
(2) Service information identified in this AD that is not incorporated by reference is available at the addresses specified in paragraphs (n)(3) and (n)(4) of this AD.
(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 Alert Service Bulletin 747-53A2499, Revision 3, dated July 15, 2014.
(ii) Reserved.
(3) For service information identified in this AD, contact Boeing Commercial Airplanes, Attention: Data & Services Management, P.O. Box 3707, MC 2H-65, Seattle, WA 98124-2207; telephone 206-544-5000, extension 1; fax 206-766-5680; Internet
(4) You may view this service information at FAA, Transport Airplane Directorate, 1601 Lind Avenue SW., Renton, WA. For information on the availability of this material at the FAA, call 425-227-1221.
(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:
Federal Aviation Administration (FAA), Department of Transportation (DOT).
Final rule.
We are superseding an airworthiness directive (AD) 2014-03-18 for B-N Group Ltd. Models BN-2, BN-2A, BN-2A-2, BN-2A-3, BN-2A-6, BN-2A-8, BN-2A-9, BN-2A-20, BN-2A-21, BN-2A-26, BN-2A-27, BN-2B-20, BN-2B-21, BN-2B-26, BN-2B-27, BN2A MK. III, BN2A MK. III-2, and BN2A MK. III-3 airplanes. This AD results from mandatory continuing airworthiness information (MCAI) issued by an aviation authority of another country to identify and correct an unsafe condition on an aviation product. The MCAI describes the unsafe condition as damage of the cable sliding end assembly and installation of the incorrect end fitting on engine control cable assemblies. We are issuing this AD to require actions to address the unsafe condition on these products.
This AD is effective March 24, 2016.
The Director of the Federal Register approved the incorporation by reference of a certain publication listed in the AD as of March 24, 2016.
The Director of the Federal Register approved the incorporation by reference of a certain other publication listed in this AD as of April 1, 2014 (79 FR 10340, February 25, 2014).
You may examine the AD docket on the Internet at
For service information identified in this final rule, contact Britten-Norman Aircraft Limited, Commodore House, Mountbatten Business Centre, Millbrook Road East, Southampton SO15 1HY, United Kingdom; telephone: +44 20 3371 4000; fax: +44 20 3371 4001; email:
Raymond Johnston, Aerospace Engineer, FAA, Small Airplane Directorate, 901 Locust, Room 301, Kansas City, Missouri 64106; telephone: (816) 329-4159; fax: (816) 329-3047; email:
We issued a notice of proposed rulemaking (NPRM) to amend 14 CFR part 39 by adding an AD that would apply to B-N Group Ltd. Models BN-2, BN-2A, BN-2A-2, BN-2A-3, BN-2A-6, BN-2A-8, BN-2A-9, BN-2A-20, BN-2A-21, BN-2A-26, BN-2A-27, BN-2B-20, BN-2B-21, BN-2B-26, BN-2B-27, BN2A MK. III, BN2A MK. III-2, and
The NPRM proposed to correct an unsafe condition for the specified products and was based on mandatory continuing airworthiness information (MCAI) originated by an aviation authority of another country. The MCAI states that:
Britten-Norman Aircraft Limited was made aware of two occurrences where a failure of engine control cable assemblies has caused engine control difficulties. In both reported cases, the cable sliding end assemblies were in poor condition and in both cases, an incorrect end-fitting was installed, which may have contributed to the failures.
This condition, if not detected and corrected, could result in reduced engine control, possibly resulting in reduced control of the aeroplane.
To address this potential unsafe condition, Britten-Norman Aircraft issued Service Bulletin (SB) 334 to provide inspection instructions, and EASA issued AD 2013-0215 to require a one-time inspection and functional test of the engine control cables and, depending on findings, replacement of the cables.
Subsequently, as it was found that BN2 “Islander” aeroplanes were mistakenly omitted from the AD applicability, EASA issued AD 2013-0263, retaining the requirements of EASA AD 2013-0215, which was superseded, and extending the applicability to BN2 aeroplanes.
Since EASA AD 2013-0263 was issued, it was found that certain parts, specific to BN2A “Trislander” aeroplanes only, were inadvertently not included in SB 334 and, as a consequence, not required by AD 2013-0263 to be inspected.
Prompted by these findings, Britten-Norman revised SB 334 (now at issue 2) to include the missing parts.
For the reason described above, this AD retains the requirements of EASA AD 2013-0263, which is superseded, and adds inspection requirements for the additional parts.
We gave the public the opportunity to participate in developing this AD. We received no comments on the NPRM or on the determination of the cost to the public.
We reviewed the relevant data and determined that air safety and the public interest require adopting the AD as proposed except for minor editorial changes. We have determined that these minor changes:
• Are consistent with the intent that was proposed in the NPRM (80 FR 66482, October 29, 2015) for correcting the unsafe condition; and
• Do not add any additional burden upon the public than was already proposed in the NPRM (80 FR 66482, October 29, 2015).
We reviewed Britten-Norman Aircraft Limited Service Bulletin No. SB 334, Issue 1, dated August 30, 2013; and Britten-Norman Aircraft Limited Service Bulletin No. SB 334, Issue 2, dated July 17, 2015. The service information describes procedures for inspection and replacement if necessary of the engine control cable assemblies. 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
We estimate that this AD will affect 96 products of U.S. registry. We also estimate that it would take about 1 work-hour per product to comply with the basic requirements of this proposed AD. The average labor rate is $85 per work-hour.
Based on these figures, we estimate the cost of this AD on U.S. operators to be $8,160 or $85 per product.
In addition, we estimate that any necessary follow-on actions would take about 10 work-hours and require parts costing $6,000, for a cost of $6,850 per product. We have no way of determining the number of products that may need these actions.
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.
We determined that 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 this AD:
(1) Is not a “significant regulatory action” under Executive Order 12866,
(2) Is not a “significant rule” under the 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.
You may examine the AD docket on the Internet at
Air transportation, Aircraft, Aviation safety, Incorporation by reference, Safety.
Accordingly, under the authority delegated to me by the Administrator, the FAA amends 14 CFR part 39 as follows:
49 U.S.C. 106(g), 40113, 44701.
This airworthiness directive (AD) becomes effective March 24, 2016.
This AD supersedes AD 2014-03-18, Amendment 39-17755 (79 FR 10340; February 25, 2014) (“AD 2014-03-18”).
This AD applies to B-N Group Ltd. Models BN-2, BN-2A, BN-2A-2, BN-2A-3, BN-2A-6, BN-2A-8, BN-2A-9, BN-2A-20, BN-2A-21, BN-2A-26, BN-2A-27, BN-2B-20, BN-2B-21, BN-2B-26, BN-2B-27, BN2A MK. III, BN2A MK. III-2, and BN2A MK. III-3 airplanes, all serial numbers, certificated in any category.
Air Transport Association of America (ATA) Code 76: Engine Controls.
This AD was prompted by mandatory continuing airworthiness information (MCAI) originated by an aviation authority of another country to identify and correct an unsafe condition on an aviation product. The MCAI describes the unsafe condition as possible damage of the cable sliding end assembly and installation of the incorrect end fitting on engine control cable assemblies. We are issuing this proposed AD to detect and correct damage of the cable sliding end assembly (cracking, distortion, corrosion) and incorrect end fittings on the engine control assemblies, which could lead to reduced engine control with consequent loss of control, and to incorporate revised service information with updated information on applicability and on the identity of parts to be inspected on some airplanes.
Unless already done, do the actions in paragraphs (f)(1) through (f)(6) of this AD:
(1)
(2)
(3)
(4)
(5)
(6)
(7)
(8)
The following provisions also apply to this AD:
(1)
(2)
Refer to MCAI European Aviation Safety Agency (EASA) AD No.: 2015-0184, dated September 1, 2015; for related information. The MCAI can be found in the AD docket on the Internet at:
(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.
(3) The following service information was approved for IBR on March 24, 2016 (the effective date of this AD).
(i) Britten-Norman Aircraft Limited Service Bulletin No. SB 334, Issue 2, dated July 17, 2015.
(ii) Reserved.
(4) The following service information was approved for IBR on April 1, 2014 (79 FR 10340; February 25, 2014).
(i) Britten-Norman Aircraft Limited Service Bulletin No. SB 334, Issue 1, dated August 30, 2013.
(ii) Reserved.
(5) For Britten-Norman service information identified in this AD, contact Britten-Norman Aircraft Limited, Commodore House, Mountbatten Business Centre, Millbrook Road East, Southampton SO15 1HY, United Kingdom; telephone: +44 20 3371 4000; fax: +44 20 3371 4001; email:
(6) You may view this service information at FAA, Small Airplane Directorate, 901 Locust, Kansas City, Missouri 64106. For information on the availability of this material at the FAA, call 816-329-4148. In addition, you can access this service information on the Internet at
(7) You may view this service information that is incorporated by reference at the National Archives and Records Administration (NARA). For information on
Food and Drug Administration, HHS.
Final order.
The Food and Drug Administration (FDA) is issuing a final order to require the filing of a premarket approval application (PMA) or a notice of completion of a product development protocol (PDP) for the hip joint metal/metal semi-constrained, with a cemented acetabular component, prosthesis; and hip joint metal/metal semi-constrained, with an uncemented acetabular component, prosthesis.
This order is effective on February 18, 2016.
Sergio M. de del Castillo, Center for Devices and Radiological Health, 10903 New Hampshire Ave., Bldg. 66, Rm. 1538, Silver Spring, MD 20993, 301-796-6419.
The Federal Food, Drug, and Cosmetic Act (the FD&C Act), as amended by the Medical Device Amendments of 1976 (the 1976 amendments) (Pub. L. 94-295), the Safe Medical Devices Act of 1990 (Pub. L. 101-629), the Food and Drug Administration Modernization Act of 1997 (Pub. L. 105-115), the Medical Device User Fee and Modernization Act of 2002 (Pub. L. 107-250), the Medical Devices Technical Corrections Act (Pub. L. 108-214), the Food and Drug Administration Amendments Act of 2007 (Pub. L. 110-85), and the Food and Drug Administration Safety and Innovation Act (FDASIA) (Pub. L. 112-144), among other amendments, established a comprehensive system for the regulation of medical devices intended for human use. Section 513 of the FD&C Act (21 U.S.C. 360c) established three categories (classes) of devices, reflecting the regulatory controls needed to provide reasonable assurance of their safety and effectiveness. The three categories of devices are class I (general controls), class II (special controls), and class III (premarket approval).
Under section 513(d) of the FD&C Act, devices that were in commercial distribution before the enactment of the 1976 amendments, May 28, 1976 (generally referred to as preamendments devices), are classified after FDA has: (1) Received a recommendation from a device classification panel (an FDA advisory committee); (2) published the panel's recommendation for comment, along with a proposed regulation classifying the device; and (3) published a final regulation classifying the device. FDA has classified most preamendments devices under these procedures.
Devices that were not in commercial distribution prior to May 28, 1976 (generally referred to as postamendments devices), are automatically classified by section 513(f) of the FD&C Act into class III without any FDA rulemaking process. Those devices remain in class III and require premarket approval unless, and until, the device is reclassified into class I or II or FDA issues an order finding the device to be substantially equivalent, in accordance with section 513(i) of the FD&C Act, to a predicate device that does not require premarket approval. The Agency determines whether new devices are substantially equivalent to predicate devices by means of premarket notification procedures in section 510(k) of the FD&C Act (21 U.S.C. 360(k)) and 21 CFR part 807.
A preamendments device that has been classified into class III and devices found substantially equivalent by means of premarket notification (510(k)) procedures to such a preamendments device or to a device within that type (both the preamendments and substantially equivalent devices are referred to as preamendments class III devices) may be marketed without submission of a PMA until FDA issues a final order under section 515(b) of the FD&C Act (21 U.S.C. 360e(b)) requiring premarket approval. Section 515(b)(1) of the FD&C Act directs FDA to issue an order requiring premarket approval for a preamendments class III device.
Although, under the FD&C Act, the manufacturer of a preamendments class III device may respond to the call for PMAs by filing a PMA or a notice of completion of a PDP. In practice, the option of filing a notice of completion of a PDP has rarely been used. For simplicity, although the PDP option remains available to manufacturers in response to a final order under section 515(b) of the FD&C Act, this document will refer only to the requirement for the filing of, and obtaining approval of, a PMA.
On July 9, 2012, FDASIA was enacted. Section 608(a) of FDASIA amended section 513(e) of the FD&C Act, changing the process for reclassifying a device from rulemaking to an administrative order. Section 608(b) of FDASIA amended section 515(b) of the FD&C Act, changing the process for requiring premarket approval for a preamendments class III device from rulemaking to an administrative order.
FDA is requiring PMAs for total metal-on-metal (MoM) semi-constrained hip joint systems (heretofore referenced as “MoM hips”), which include the following two specific preamendments class III devices: Hip joint metal/metal semi-constrained, with a cemented acetabular component, prosthesis; and hip joint metal/metal semi-constrained, with an uncemented acetabular component, prosthesis.
Section 515(b)(1) of the FD&C Act sets forth the process for issuing a final order. Specifically, prior to the issuance of a final order requiring premarket approval for a preamendments class III device, the following must occur: (1) Publication of a proposed order in the
Section 515(b)(3) of the FD&C Act provides that FDA shall, after the close of the comment period on the proposed order, consideration of any comments received, and a meeting of a device classification panel described in section 513(b) of the FD&C Act, issue a final order to require premarket approval or publish a document terminating the proceeding together with the reasons for such termination.
A preamendments class III device may be commercially distributed without a PMA until 90 days after FDA issues a final order (a final rule issued
Also, a preamendments device subject to the order process under section 515(b) of the FD&C Act is not required to have an approved investigational device exemption (IDE) (see part 812 (21 CFR part 812)) contemporaneous with its interstate distribution until the date identified by FDA in the final order, requiring the filing of a PMA for the device. At that time, an IDE is required only if a PMA has not been filed. If the manufacturer, importer, or other sponsor of the device submits an IDE application and FDA approves it, the device may be distributed for investigational use. If a PMA is not filed by the later of the two dates, and the device is not distributed for investigational use under an IDE, the device is deemed to be adulterated within the meaning of section 501(f)(1)(A) of the FD&C Act, and subject to seizure and condemnation under section 304 of the FD&C Act (21 U.S.C. 334), if its distribution continues. Other enforcement actions include, but are not limited to, the following: Shipment of devices in interstate commerce may be subject to injunction under section 302 of the FD&C Act (21 U.S.C. 332), and the individuals responsible for such shipment may be subject to prosecution under section 303 of the FD&C Act (21 U.S.C. 333).
FDA held a meeting of a device classification panel described in section 513(b) of the FD&C Act with respect to MoM hips on August 8, 2001, and therefore, has met this requirement under section 515(b)(1) of the FD&C Act. The panel recommended that the devices remain in class III because there was insufficient information to establish special controls; the panel also agreed unanimously that MoM hips are for a use which is of substantial importance in preventing impairment of human health (Ref. 1). FDA is not aware of new information that would provide a basis for a different recommendation or findings, and the recent reports and evaluations discussed in the proposed order further support that reclassification of MoM hips is not appropriate. Furthermore, the problems identified in the medical device reporting systems and recalls for MoM hips further indicate the need to review these devices under a PMA to provide reasonable assurance of their safety and effectiveness.
FDA received and has considered several sets of comments from nine commenters on the proposed order, as discussed in section II.
In response to the January 18, 2013 (78 FR 4094), proposed order to require premarket approval for MoM hips, FDA received several sets of comments from nine commenters. These comments, as well as the Agency's consideration of them, are summarized further in this section.
Six commenters generally agreed with FDA's proposal to require PMAs for MoM hips. One commenter (the American Academy of Orthopaedic Surgeons, also referred to as AAOS) stated that the existing data is not adequate to support reclassification of MoM hips because special controls could not be established to provide a reasonable assurance of device safety and effectiveness. This comment echoes the findings and recommendations of the August 8, 2001, panel.
Another commenter stated that MoM hip resurfacing devices should be classified as Class III; however, MoM hip resurfacing devices are not regulated under 21 CFR 888.3320 or 21 CFR 888.3330 and are not the subject of this order.
Several commenters requested that all currently marketed MoM hips be removed from the market, either through a FDA-initiated recall or voluntary action by the device manufacturer.
As explained in more detail in section III of this order, if a PMA for a currently marketed MoM hip is not filed on or before the 90th day past the effective date of this order, that device will be deemed adulterated under section 501(f)(1)(A) of the FD&C Act, and commercial distribution of the device must cease immediately. FDA intends to take appropriate action to ensure compliance with the 90-day deadline for the submission of PMAs. The Agency believes this information adequately addresses the commenters' concern.
One commenter recommended standardizing the modularity and other design features of MoM hips to mitigate adverse events attributed to the manufacturing process for these devices. The Agency does not believe sufficient information exists to establish any manufacturing standards or specific technical specifications for MoM hips that could potentially be generalized for this technology to mitigate adverse events.
One commenter requested that the Agency set revision surgery standards. Revision surgery involves a complex clinical decision that falls within the practice of medicine, which FDA generally does not regulate. In addition, insufficient information exists to establish any standards for revision surgery. FDA notes, however, that the American Association of Hip and Knee Surgeons, the American Academy of Orthopaedic Surgeons, and the Hip Society issued a consensus statement regarding assessment of risks in patients implanted with MoM hips, including factors to consider for revision surgery, based on currently available information (Ref. 2). FDA's Web site for MoM hips also provides some general considerations regarding revision surgery (Ref. 3).
One commenter requested that MoM hips not be used in women, including those of child-bearing age, and children who are still growing (
One commenter requested the adoption of standards for metal ion levels in the serum of patients implanted with a MoM hip. As discussed in detail during the June 28, 2012, panel meeting, there are challenges to implementing metal ion testing into clinical evaluations of patients treated with MoM hips, as well as challenges in the interpretation of metal ion testing results (Ref. 5). For example, the equipment and expertise required to conduct such testing are currently not widely available in health care facilities. In addition, there can be significant variability in test results, based on a number of factors, including
One commenter stated that FDA should affirmatively assert that common law liability claims relating to MoM hips that are included under this final order, which were cleared through the 510(k) process before the effective date of this final order, should not be preempted under section 521 of the FD&C Act (21 U.S.C. 360k). Section 521 of the FD&C Act includes an express preemption provision that preempts certain state requirements that are “different from, or in addition to” certain Federal requirements applicable to devices. Two Supreme Court cases:
Finally, several comments recommended actions that address broader issues or programmatic areas, such as changes to the postmarket surveillance process for all class III medical devices, recommendations for research studies, and the establishment of a “trust fund” for healthcare reimbursement of failed MoM hips. These requests are outside the scope of the regulatory actions described in this order.
Under section 515(b)(3) of the FD&C Act, FDA is adopting its findings as published in the proposed order (78 FR 4094), and is issuing this final order to require the filing of a PMA for MoM hips, which specifically includes the following two device types: Hip joint metal/metal semi-constrained, with a cemented acetabular component, prosthesis; and hip joint metal/metal semi-constrained, with an uncemented acetabular component, prosthesis. This final order will revise 21 CFR part 888.
Under the final order, a PMA is required to be filed on or before May 18, 2016, for any of these preamendments class III devices that were in commercial distribution before May 28, 1976, or that has been found by FDA to be substantially equivalent to such a device on or before May 18, 2016. An applicant of a device subject to this order that was legally in commercial distribution before May 28, 1976, or that has been found to be substantially equivalent to a device that was legally in commercial distribution before May 28, 1976, may continue marketing such class III device during FDA's review of the PMA provided that the PMA is filed on or before May 18, 2016. However, if FDA denies approval of the PMA, then the device will be deemed adulterated under section 501(f)(1)(A) of the FD&C Act, and commercial distribution of the device must cease immediately. Any other device subject to this order is required to have an approved PMA in effect before it may be marketed. FDA intends to review any PMA for the device within 180 days, and any notice of completion of a PDP for the device within 90 days of the date of filing. FDA cautions that under section 515(d)(1)(B)(i) of the FD&C Act, the Agency may not enter into an agreement to extend the review period for a PMA beyond 180 days unless the Agency finds that “the continued availability of the device is necessary for the public health.”
If a PMA for any of the preamendments class III devices subject to this order is not filed on or before May 18, 2016, that device will be deemed adulterated under section 501(f)(1)(A) of the FD&C Act, and commercial distribution of the device must cease immediately. FDA requests that manufacturers take action to prevent the further use of MoM hips for which no PMA has been filed.
The device may, however, be distributed for investigational use, if the applicable requirements of the IDE regulations (part 812), including obtaining IDE approval, are met on or before 90 days after the effective date of this order. There will be no extended period for filing an IDE or exemption from the IDE requirements (see § 812.2(d)), and clinical studies may not be initiated without appropriate IDE approvals, as required.
The Agency has 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.
This final order refers to previously approved collections of information found in FDA regulations. 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 21 CFR part 812 have been approved under OMB control number 0910-0078; the collections of information in 21 CFR part 807, subpart E, have been approved under OMB control number 0910-0120;
Prior to the amendments by FDASIA, section 515(b) of the FD&C Act provided for FDA to issue regulations to require approval of an application for premarket approval for preamendments devices or devices found substantially equivalent to preamendments devices. Section 515(b) of the FD&C Act, as amended by FDASIA, provides for FDA to require approval of an application for premarket approval for such devices by issuing a final order following the issuance of a proposed order in the
The following references are on display in the Division of Dockets Management (HFA-305), Food and Drug Administration, 5630 Fishers Lane, Rm. 1061, Rockville, MD 20852, and are available for viewing by interested persons between 9 a.m. and 4 p.m., Monday through Friday; they are also available electronically at
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 888 is amended as follows:
21 U.S.C. 351, 360, 360c, 360e, 360j, 371.
(c)
(c)
Internal Revenue Service (IRS), Treasury.
Final regulations.
This document contains final regulations relating to information reporting by brokers for transactions involving debt instruments and options, including the reporting of original issue discount (OID) on tax-exempt obligations, the treatment of certain holder elections for reporting a taxpayer's adjusted basis in a debt instrument, and transfer reporting for section 1256 options and debt instruments. The regulations in this document provide guidance to brokers and payors and to their customers.
Pamela Lew of the Office of the Associate Chief Counsel (Financial Institutions and Products) at (202) 317-7053 (not a toll-free number).
The collection of information contained in §§ 1.6045-1(n) and 1.6045A-1(b) of these final regulations has been reviewed and approved by the Office of Management and Budget in accordance with the Paperwork Reduction Act of 1995 (44 U.S.C. 3507(d)) under control number 1545-2186. The collection of information is required to comply with the provisions of section 403 of the Energy Improvement and Extension Act of 2008, Division B of Public Law 110-343 (122 Stat. 3765, 3854 (2008)) (the Act). The information required under § 1.6045-1(n) minimizes the need for reconciliation between information reported by a broker to both a customer and the IRS and the amounts reported on the customer's tax return. The information required under § 1.6045A-1 is necessary to allow brokers that effect sales of transferred section 1256 options and debt instruments that are covered securities to determine and report the adjusted basis of these securities in compliance with section 6045(g) of the Internal Revenue Code (Code). The burden for the collection of information contained in § 1.6049-10 of these final regulations will be reflected in the burden for Form 1099-OID, Original Issue Discount (OMB control number 1545-0117), when it is revised to request the additional information in the regulations. This information is required to enable the IRS to verify that a taxpayer is reporting the correct amount of tax-exempt interest each year for alternative minimum tax and other purposes. In addition, because this information is used to determine a taxpayer's adjusted basis in a debt instrument for purposes of section 6045(g), this information is required to enable the IRS to verify that a taxpayer is reporting the correct amount of gain or loss upon the sale of a tax-exempt obligation.
An agency may not conduct or sponsor, and a person is not required to respond to, a collection of information unless it displays a valid control number assigned by the Office of Management and Budget.
Books or records relating to a collection of information must be retained as long as their contents may become material in the administration of any internal revenue law. Generally, tax returns and tax return information are confidential, as required by section 6103.
Section 6045 generally requires a broker to report gross proceeds upon the sale of a security. Section 6045 was amended by section 403 of the Act to require the reporting of adjusted basis for a covered security and whether any gain or loss upon the sale of the security is long-term or short-term. In addition, the Act added section 6045A of the Code, which requires certain information to be reported in connection with a transfer of a covered security to another broker, and section 6045B of the Code, which requires an issuer of a specified security to file a return relating to certain actions that affect the basis of the security. Section 6049 requires the reporting of interest payments (including accruals of OID treated as payments).
On November 25, 2011, the Treasury Department and the IRS published in the
On March 13, 2015, the Treasury Department and the IRS published in the
Written comments were received on the 2015 proposed reporting regulations and are summarized below. No public hearing was requested or held. In general, these final regulations adopt the provisions of the 2015 proposed reporting regulations. These final regulations also remove the corresponding 2015 temporary reporting regulations.
After the publication of the 2015 final basis reporting regulations, the Treasury Department and the IRS received written comments on certain provisions of the final basis reporting regulations. In response to these comments, this document contains final regulations under section 6045 relating to the treatment of certain debt instruments as non-covered securities.
The written comments on the 2015 proposed reporting regulations and the 2015 final basis reporting regulations are available for public inspection at
Under section 1276(b)(2), a customer may elect to accrue market discount on a constant yield method rather than a ratable method. The election may be made on a debt instrument by debt instrument basis and must be made for the earliest taxable year for which the customer is required to determine
In response to comments on the 2013 final basis reporting regulations (which required the broker to assume that the customer had not made a constant yield election), § 1.6045-1T(n)(11)(i)(B) of the 2015 temporary reporting regulations provided that for a debt instrument acquired on or after January 1, 2015, brokers are required to assume that a customer has elected to determine accrued market discount using a constant yield method unless the customer notifies the broker otherwise. A customer that does not want to use a constant yield method to determine accrued market discount must, by the end of the calendar year in which the customer acquired the debt instrument in an account with the broker, notify the broker in writing that the customer wants the broker to use the ratable method to determine accrued market discount.
No comments were received on the substantive rules in § 1.6045-1T(n)(11)(i)(B). Accordingly, the rules in the final regulations in this document are the same as the rules in § 1.6045-1T(n)(11)(i)(B). Several commenters requested permission to apply the default constant yield method to debt instruments acquired on or after January 1, 2014, which was the first date for which a broker was required to report accrued market discount under section 6045, provided that the broker had not reported accrued market discount to a customer for the 2014 calendar year using the ratable method. According to the commenters, the use of a single method to compute market discount accruals for all covered securities with market discount would simplify the calculation of accrued market discount and the reporting of this information to their customers.
The final regulations in this document permit, but do not require, a broker to apply the default constant yield method to a debt instrument acquired on or after January 1, 2014, and before January 1, 2015, provided the broker was not informed that the customer had made a section 1278(b) election (the election to include market discount in income as it accrues rather than upon a disposition or receipt of a partial principal payment), there were no principal payments on the debt instrument during the 2014 calendar year, and the broker therefore had not reported accrued market discount to the customer for the 2014 calendar year using the ratable method.
Under § 1.6045A-1T(e) of the 2015 temporary reporting regulations, a transferring broker is required to provide a transfer statement upon the transfer of a section 1256 option to ensure that the receiving broker has all of the information required for purposes of section 6045. The temporary regulations provide that a transfer statement is required for the transfer of a section 1256 option that occurs on or after January 1, 2016. The temporary regulations also list the data specific to section 1256 options that must be provided.
One commenter asserted that including the fair market value information on a transfer statement for a section 1256 option is unnecessary because the receiving broker can look up the information if it is needed and suggested saving space on the transfer statement by eliminating this data item. After considering the suggestion, the Treasury Department and IRS decline to adopt this suggestion. Providing fair market value information on a transfer statement will help ensure that the receiving broker is reporting an amount of realized but unrecognized gain or loss from the prior year that is consistent with the amount reported in the prior year by the transferring broker, which will minimize the possibility of double counting or omission of gain or loss.
No other comments were received on § 1.6045A-1T of the 2015 temporary reporting regulations. The rules in the final regulations in this document are substantively the same as the rules in the 2015 temporary regulations. However, the rules in § 1.6045A-1T(e) are in § 1.6045A-1(b)(4)(iv) of the final regulations in this document and the rules in § 1.6045A-1T(f) are in § 1.6045A-1(b)(3)(x) of the final regulations in this document.
To coordinate the reporting of OID under section 6049 with the reporting of basis for tax-exempt obligations under section 6045, § 1.6049-10T of the 2015 temporary reporting regulations provides that a payor must report under section 6049 the daily portions of OID on a tax-exempt obligation. The daily portions of OID are determined as if section 1272 and § 1.1272-1 applied to a tax-exempt obligation. A payor must determine whether a tax-exempt obligation was issued with OID and the amount that accrues for each relevant period. In addition, OID on a tax-exempt obligation is determined without regard to the de minimis rule in section 1273(a)(3) and § 1.1273-1(d). Because the temporary regulations require the reporting of OID, payors also must report amortized acquisition premium (which offsets OID) on a tax-exempt obligation. A broker may report either a gross amount for both OID and amortized acquisition premium, or a net amount of OID that reflects the offset of the OID by the amount of amortized acquisition premium allocable to the OID. Section 1.6049-10T of the 2015 temporary reporting regulations applies to a tax-exempt obligation acquired on or after January 1, 2017.
No comments were received on the substantive rules in § 1.6049-10T. Accordingly, the rules in the final regulations in this document are the same as the rules in § 1.6049-10T. However, several commenters requested that, for taxable years beginning after December 31, 2016, a broker be permitted to report on Form 1099-OID the OID and acquisition premium on a tax-exempt obligation that is a covered security acquired before January 1, 2017. According to the commenters, customers might be confused because of the difference between the date that a tax-exempt obligation generally became a covered security (that is, an obligation acquired on or after January 1, 2014), and the date after which a tax-exempt obligation that is a covered security becomes subject to mandatory reporting of OID and acquisition premium (that is, an obligation acquired on or after January 1, 2017). Because a broker is required to track basis for a tax-exempt obligation that is a covered security for purposes of section 6045, the broker is responsible for calculating OID on a tax-exempt obligation acquired on or after January 1, 2014, even if the broker has no obligation to report the obligation's OID to the customer for purposes of section 6049. To simplify the reporting of OID and acquisition premium and to minimize any customer confusion, the commenters requested that the final regulations permit a broker to report OID and acquisition discount on all tax-exempt bonds that are covered securities.
After considering the requests, for taxable years beginning after December 31, 2016, the final regulations in this document permit, but do not require, a broker to report OID and acquisition discount for a tax-exempt obligation that is a covered security acquired before January 1, 2017.
Under § 1.6045-1(n)(3) of the 2013 final basis reporting regulations, certain debt instruments are subject to basis reporting only if the debt instrument is acquired by a customer on or after January 1, 2016. For example, § 1.6045-1(n)(3) applies to a contingent payment debt instrument, a debt instrument that is not issued by a U.S. issuer, and a debt instrument the terms of which are not reasonably available to a broker within 90 days of acquisition of the debt instrument by the customer.
Several commenters on the 2013 final basis reporting regulations requested guidance for a debt instrument the terms of which are not reasonably available to the broker. The commenters stated that they would not have the information necessary to comply with the information reporting rules for these instruments. Several commenters stated that information for a debt instrument issued by a non-U.S. issuer and for a tax-exempt obligation is particularly difficult to obtain. One commenter noted that under SEC Release 34-67908, issued on September 21, 2012 (77 FR 59427), issuers of municipal securities are required to provide certain data to the Electronic Municipal Market Access system set up by the Municipal Securities Rulemaking Board for new issuances, but there is no requirement to file similar information for issuances already outstanding as of the November 1, 2012, effective date of the release.
The Treasury Department and the IRS agree that a broker may not always be able to obtain information for a debt instrument issued by a non-U.S. issuer or for a tax-exempt obligation issued before January 1, 2014. The final regulations in this document therefore provide that a debt instrument issued by a non-U.S. issuer or a tax-exempt obligation issued before January 1, 2014, is treated as a noncovered security (and, therefore, is not subject to basis reporting under section 6045) if the terms of the debt instrument are not reasonably available to the broker within 90 days of the date the debt instrument was acquired by the customer. The Treasury Department and the IRS believe that the information necessary for section 6045 compliance should be available for other debt instruments.
The final regulations under section 6045 in this document (other than § 1.6045-1(n)(12)) apply to a debt instrument acquired on or after January 1, 2015. Section 1.6045-1(n)(12) applies to a debt instrument acquired on or after February 18, 2016. The final regulations under section 6049 in this document apply to a tax-exempt obligation that is a covered security acquired on or after January 1, 2017. The final regulations under section 6045A in this document apply to a transfer of a section 1256 option that occurs on or after January 1, 2016, and to a transfer of a debt instrument that occurs on or after January 1, 2016.
Certain IRS regulations, including this one, are exempt from the requirements of Executive Order 12866, as supplemented and reaffirmed by Executive Order 13563. Therefore, a regulatory assessment is not required. It also has been determined that section 553(b) of the Administrative Procedure Act (5 U.S.C. chapter 5) does not apply to these regulations.
It is hereby certified that the final regulations in this document will not have a significant economic impact on a substantial number of small entities. Therefore, a Regulatory Flexibility Analysis under the Regulatory Flexibility Act (5 U.S.C. chapter 6) is not required. It is anticipated that the requirements in the final regulations in this document, except in the case of the notification by a customer discussed in the next paragraph, will fall only on financial services firms with annual receipts greater than the $38.5 million threshold and, therefore, on no small entities.
Section 403(a) of the Act requires a broker to report the adjusted basis of a debt instrument that is a covered security. Although a holder of a debt instrument (customer) is permitted to make a number of elections that affect how basis is computed, a broker only is required to take into account specified elections in reporting the adjusted basis of a debt instrument, including the election under section 1276(b)(2) to determine accruals of market discount on a constant yield method. Under the 2013 final basis reporting regulations, a customer was required to notify the broker that the customer had made the section 1276(b)(2) election. However, § 1.6045-1(n)(11)(i)(B) requires a broker to take into account the election under section 1276(b)(2) in reporting a debt instrument's adjusted basis unless the customer timely notifies the broker that the customer has not made the election. The notification must be in writing, which includes a writing in electronic format. In most cases, this election results in a more taxpayer-favorable result than the default ratable method. It is anticipated that this collection of information in the regulations will not fall on a substantial number of small entities, especially because fewer customers will need to notify brokers about the election. Further, the regulations implement the statutory requirements for reporting adjusted basis under section 403 of the Act. Moreover, any economic impact is expected to be minimal because it should take a customer no more than seven minutes to satisfy the information-sharing requirement in these regulations.
Section 403(c) of the Act added section 6045A, which requires applicable persons to provide a transfer statement in connection with the transfer of custody of a covered security. Section 1.6045A-1 effectuates the Act by giving the broker who receives the transfer statement the information necessary to determine and report adjusted basis and whether any gain or loss with respect to a debt instrument or section 1256 option is long-term or short-term as required by section 6045 when the security is subsequently sold. Consequently, § 1.6045A-1 does not add to the impact on small entities imposed by the statutory provisions. Instead, the regulations limit the information to be reported to only those items necessary to effectuate the statutory scheme.
The information required under § 1.6049-10 will enable the IRS to verify that a taxpayer is reporting the correct amount of tax-exempt interest each year for alternative minimum tax and other purposes. In addition, because this information is used to determine a taxpayer's adjusted basis in a debt instrument for purposes of section 6045(g), this information is required to enable the IRS to verify that a taxpayer is reporting the correct amount of gain or loss upon the sale of a tax-exempt obligation. Any economic impact on small entities is expected to be minimal because a broker already is required to determine the accruals of OID and acquisition premium for purposes of determining and reporting a customer's adjusted basis on Form 1099-B under section 6045. Moreover, any effect on small entities of the rules in the final regulations flows from section 6049 and section 403 of the Act.
Therefore, because the final regulations in this document will not have a significant economic impact on a substantial number of small entities, a regulatory flexibility analysis is not required.
Pursuant to section 7805(f) of the Internal Revenue Code, the proposed regulations preceding the final regulations in this document were
The principal author of these regulations is Pamela Lew, Office of Associate Chief Counsel (Financial Institutions and Products). However, other personnel from the Treasury Department and the IRS participated in their development.
Income taxes, Reporting and recordkeeping requirements.
Accordingly, 26 CFR part 1 is amended as follows:
26 U.S.C. 7805 * * *
Section 1.6049-10 also issued under 26 U.S.C. 6049(a). * * *
The revisions and additions read as follows:
(n) * * *
(4) * * * However, see paragraph (n)(11) of this section for the treatment of an election described in paragraph (n)(4)(iii) of this section (election to accrue market discount based on a constant yield) and an election described in paragraph (n)(4)(iv) of this section (election to treat all interest as OID).
(iv) * * * However, see paragraph (n)(11)(i)(A) of this section for a debt instrument acquired on or after January 1, 2014.
(5) * * *
(i) * * * However, see paragraph (n)(11) of this section for the treatment of an election described in paragraph (n)(4)(iii) of this section (election to accrue market discount based on a constant yield) and an election described in paragraph (n)(4)(iv) of this section (election to treat all interest as OID).
(6) * * *
(i) * * * See paragraphs (n)(5) and (n)(11)(i)(B) of this section to determine whether the amount reported should take into account a customer election under section 1276(b)(2). * * *
(ii) * * * See paragraphs (n)(5) and (n)(11)(i)(B) of this section to determine whether the amount reported should take into account a customer election under section 1276(b)(2).
(7) * * *
(iii) * * * However, if a broker took into account a customer election under § 1.1272-3 in 2014, the broker must decrease the customer's basis in the debt instrument by the amount of acquisition premium that is taken into account each year to reduce the amount of the original issue discount that is otherwise includible in the customer's income for that year in accordance with §§ 1.1272-2(b)(5) and 1.1272-3.
(11)
(A)
(B)
(ii) [Reserved].
(12)
(A) A debt instrument issued by a non-U.S. issuer; or
(B) A tax-exempt obligation issued before January 1, 2014.
(ii)
(h) through (p) [Reserved]. For further guidance, see § 1.6045-1(h) through (p).
The additions read as follows:
(b) * * *
(3) * * *
(x) For a transfer that occurs on or after January 1, 2016, the last date on or before the transfer date that the transferor made an adjustment for a particular item (for example, the last date on or before the transfer date that bond premium was amortized). A broker, however, may rely on this paragraph (b)(3)(x) for a transfer of a covered security that occurs on or after June 30, 2015, and before January 1, 2016.
(4) * * *
(iv) For a transfer of an option described in § 1.6045-1(m)(3) (section 1256 option) that occurs on or after January 1, 2016, the original basis of the option and the fair market value of the option as of the end of the prior calendar year.
(a)
(b)
(c)
Federal Aviation Administration (FAA), DOT.
Notice of proposed rulemaking (NPRM).
We propose to adopt a new airworthiness directive (AD) for certain Airbus Model A300 B4-603, B4-605R, and B4-622R airplanes; and Model A310-304, -324, and -325 airplanes. This proposed AD was prompted by a report of a crack found on door frame (FR) 73A between stringers 24 and 25. This proposed AD would require inspections around the rivet heads of the seal retainer run-out holes at certain frames and corrective actions if necessary. We are proposing this AD to detect and correct cracking of the door frame, which could result in reduced structural integrity of the airplane.
We must receive comments on this proposed AD by April 4, 2016.
You may send comments, using the procedures found in 14 CFR 11.43 and 11.45, by any of the following methods:
•
•
•
•
For service information identified in this NPRM, contact Airbus SAS, Airworthiness Office—EAW, 1 Rond Point Maurice Bellonte, 31707 Blagnac Cedex, France; telephone +33 5 61 93 36 96; fax +33 5 61 93 44 51; email
You may examine the AD docket on the Internet at
Dan Rodina, Aerospace Engineer, International Branch, ANM-116, Transport Airplane Directorate, FAA, 1601 Lind Avenue SW., Renton, WA 98057-3356; telephone 425-227-2125; fax 425-227-1149.
We invite you to send any written relevant data, views, or arguments about this proposed AD. Send your comments to an address listed under the
We will post all comments we receive, without change, to
The European Aviation Safety Agency (EASA), which is the Technical Agent for the Member States of the European Union, has issued EASA AD 2014-0202R1, dated September 19, 2014 (referred to after this as the Mandatory Continuing Airworthiness Information, or “the MCAI”), to correct an unsafe condition for certain Airbus Model A300 B4-603, B4-605R, and B4-622R airplanes; and Model A310-304, -324, and -325 airplanes The MCAI states:
During the preparation phase for conversion of an A300-600 aeroplane from passenger to freighter configuration, a crack was detected on door frame (FR) 73A, between stringer (STRG) 24 and STRG 25.
DGAC France had issued AD 1999-013-276R1 [
Further investigations identified that, on A300-600 aeroplanes, the areas at FR 56A and FR 57A have the same design and material as at FR 73A.
This condition, if not detected and corrected, could affect the structural integrity of the airframe.
For the reasons described above, this [EASA] AD requires repetitive [high frequency eddy current (HFEC)] inspections of the rivet heads of the seal retainer run out holes to detect cracks and, depending on findings, accomplishment of corrective actions [repair].
Even though no crack has been identified at FR 56A and FR 57A, as a preventive measure, the inspection is extended to these areas. On A310 aeroplanes, only the area at FR 73A needs to be inspected.
This [EASA] AD is revised to reduce the applicability to aeroplanes in post-MOD 06924 configuration.
You may examine the MCAI in the AD docket on the Internet at
Airbus has issued Service Bulletins A300-53-6175, and A310-53-2138, both dated May 28, 2014. The service
This product has been approved by the aviation authority of another country, and is approved for operation in the United States. Pursuant to our bilateral agreement with the State of Design Authority, we have been notified of the unsafe condition described in the MCAI and service information referenced above. We are proposing this AD because we evaluated all pertinent information and determined an unsafe condition exists and is likely to exist or develop on other products of these same type designs.
We estimate that this proposed AD affects 24 airplanes of U.S. registry.
We also estimate that it would take about 11 work-hours per product to comply with the basic requirements of this proposed AD. The average labor rate is $85 per work-hour. Based on these figures, we estimate the cost of this proposed AD on U.S. operators to be $22,440, or $935 per product.
We have received no definitive data that would enable us to provide cost estimates for the on-condition actions specified in this proposed AD.
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.
We determined that this proposed AD would not have federalism implications under Executive Order 13132. This proposed AD would 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 this proposed regulation:
1. Is not a “significant regulatory action” under Executive Order 12866;
2. Is not a “significant rule” under the 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.
Air transportation, Aircraft, Aviation safety, Incorporation by reference, Safety.
Accordingly, under the authority delegated to me by the Administrator, the FAA proposes to amend 14 CFR part 39 as follows:
49 U.S.C. 106(g), 40113, 44701.
We must receive comments by April 4, 2016.
None.
This AD applies to Airbus Model A300B4-603, A300B4-605R, A300B4-622R, A310-304, A310-324, and A310-325 airplanes; certificated in any category; all manufacturer serial numbers (MSNs) in post-modification (MOD) 06924 configuration, except MSN 464, 477, 479, 481, 482, 483, 484, and 488.
MSNs 464, 477, 479, 481, 482, 483, 484 and 488 partially embodied MOD 06924 by means of modification proposal D05902.
Air Transport Association (ATA) of America Code 53, Fuselage.
This AD was prompted by a report of a crack found on door frame (FR) 73A between stringers 24 and 25. We are issuing this AD to detect and correct cracking, which could reduce the structural integrity of the airplane.
Comply with this AD within the compliance times specified, unless already done.
At the later of the compliance times specified in paragraphs (g)(1) and (g)(2) of this AD: Do a high frequency eddy current (HFEC) inspection for any crack around the rivet heads of the seal retainer run-out holes at FR 56A, FR 57A, and FR 73A, left-hand (LH) and right-hand (RH) sides on Model A300-600 airplanes; and at FR 73A, LH and RH sides on Model A310 airplanes; in accordance with the Accomplishment Instructions of Airbus Service Bulletin A310-53-2138, dated May 28, 2014; or Airbus Service Bulletin A300-53-6175, dated May 28, 2014; as applicable. Repeat the HFEC inspection thereafter at intervals not to exceed 7,500 flight cycles.
(1) Before the accumulation of 32,000 total flight cycles.
(2) Within 36 months after the effective date of this AD, or before the accumulation of 36,000 total flight cycles, whichever occurs first.
If any crack is found during any inspection required by paragraph (g) of this AD, repair before further flight using a method approved by the Manager, International Branch, ANM-116, Transport Airplane Directorate, FAA; or the European Aviation Safety Agency (EASA); or Airbus's EASA Design Organization Approval (DOA).
The following provisions also apply to this AD:
(1)
(2)
(3)
(1) Refer to Mandatory Continuing Airworthiness Information (MCAI) EASA AD 2014-0202R1, dated September 19, 2014, for related information. This MCAI may be found in the AD docket on the Internet at
(2) For service information identified in this AD, contact Airbus SAS, Airworthiness Office—EAW, 1 Rond Point Maurice Bellonte, 31707 Blagnac Cedex, France; telephone +33 5 61 93 36 96; fax +33 5 61 93 44 51; email
Federal Aviation Administration (FAA), DOT.
Notice of proposed rulemaking (NPRM).
We propose to supersede Airworthiness Directive (AD) 2011-01-15, which applies to certain The Boeing Company Model 757-200, -200CB, and -300 series airplanes. AD 2011-01-15 currently requires repetitive inspections for cracking of the fuselage skin of the crown skin panel along the chem-milled step at stringers S-4L (left) and S-4R (right), from stations (STA) 297 through STA 439, and repair, if necessary. AD 2011-01-15 also includes terminating action for the repetitive inspections of the repaired areas only. Since we issued AD 2011-01-15, we received reports of the initiation of new fatigue cracking in the fuselage skin of the crown skin panel along locally thinned channels adjacent to the chem-milled steps. This proposed AD would add repetitive inspections for cracking in additional areas and repair if necessary. This proposed AD would also remove airplanes from the applicability in AD 2011-01-15. This proposed AD would also add an optional skin panel replacement which would terminate all inspections and an optional preventative modification that would terminate certain inspections. We are proposing this AD to detect and correct fatigue cracking of the fuselage skin of the crown skin panel, which could result in pressure venting and consequent rapid decompression of the airplane.
We must receive comments on this proposed AD by April 4, 2016.
You may send comments, using the procedures found in 14 CFR 11.43 and 11.45, by any of the following methods:
•
•
•
•
For service information identified in this NPRM, contact Boeing Commercial Airplanes, Attention: Data & Services Management, 3855 Lakewood Boulevard, MC D800-0019, Long Beach, CA 90846-0001; telephone: 206-544-5000, extension 2; fax: 206-766-5683; Internet
You may examine the AD docket on the Internet at
Eric Schrieber, Aerospace Engineer, Airframe Branch, ANM-120L, FAA, Los Angeles Aircraft Certification Office (ACO), 3960 Paramount Boulevard, Lakewood, CA 90712-4137; phone: 562-627-5348; fax: 562-627-5210; email:
We invite you to send any written relevant data, views, or arguments about this proposed AD. Send your comments to an address listed under the
We will post all comments we receive, without change, to
On December 28, 2010, we issued AD 2011-01-15, Amendment 39-16572 (76 FR 1351, January 10, 2011), for certain The Boeing Company Model 757-200, -200CB, and -300 series airplanes. AD 2011-01-15 requires repetitive inspections for cracking of the fuselage skin of the crown skin panel along the
The preamble to AD 2011-01-15, Amendment 39-16572 (76 FR 1351, January 10, 2011), specifies that we consider the requirements “interim action.” AD 2011-01-15 explains that we might consider further rulemaking if final action is later identified. We now have determined that it is necessary to initiate further rulemaking to add repetitive inspections for cracking in additional areas for certain airplanes, and repair if necessary.
We have removed Model 757-200 CB series airplanes from the applicability because the crown skins on those airplanes are manufactured differently and therefore are not affected by the identified unsafe condition.
We have also determined that the external detailed inspection that is allowed as an option in AD 2011-01-15, Amendment 39-16572 (76 FR 1351, January 12, 2011), does not adequately address the identified unsafe condition. Only eddy current inspections are adequate to address the identified unsafe condition.
We reviewed Boeing Special Attention Service Bulletin 757-53-0097, Revision 2, dated July 28, 2015. The service information describes procedures for repetitive external sliding probe eddy current (EC) and external spot-probe-medium-frequency EC inspections for cracking of the crown skin panel, repair, a preventive modification, and replacement of the crown skin panel. 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
We are proposing this AD because we evaluated all the relevant information and determined the unsafe condition described previously is likely to exist or develop in other products of the same type design.
This proposed AD would require accomplishing the actions specified in the service information described previously. For information on the procedures and compliance times, see this service information at
The FAA worked in conjunction with industry, under the Airworthiness Directive Implementation Aviation Rulemaking Committee (ARC), to enhance the AD system. One enhancement was a new process for annotating which steps in the service information are required for compliance with an AD. Differentiating these steps from other tasks in the service information is expected to improve an owner's/operator's understanding of crucial AD requirements and help provide consistent judgment in AD compliance. The steps identified as RC (required for compliance) in any service information identified previously have a direct effect on detecting, preventing, resolving, or eliminating an identified unsafe condition.
We estimate that this proposed AD affects 652 airplanes of U.S. registry.
We estimate the following costs to comply with this proposed AD:
We have received no definitive data that would enable us to provide a cost estimate for the on-condition actions specified in this proposed AD.
We have received no definitive data that would enable us to provide a cost estimate for the optional replacement specified in this proposed AD.
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.
We have determined that this proposed AD would not have federalism implications under Executive Order 13132. This proposed AD would 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 the proposed regulation:
(1) Is not a “significant regulatory action” under Executive Order 12866,
(2) Is not a “significant rule” under the 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.
Air transportation, Aircraft, Aviation safety, Incorporation by reference, Safety.
Accordingly, under the authority delegated to me by the Administrator, the FAA proposes to amend 14 CFR part 39 as follows:
49 U.S.C. 106(g), 40113, 44701.
The FAA must receive comments on this AD action by April 4, 2016.
This AD replaces AD 2011-01-15, Amendment 39-16572 (76 FR 1351, January 10, 2011).
(c) This AD applies to The Boeing Company Model 757-200 and -300 series airplanes, certificated in any category, as identified in Boeing Special Attention Service Bulletin 757-53-0097, Revision 2, dated July 28, 2015.
Air Transport Association (ATA) of America Code 53, Fuselage.
This AD was prompted by reports of the initiation of fatigue cracking in the fuselage skin of the crown skin panel along locally thinned channels adjacent to the chem-milled steps. We are issuing this AD to detect and correct fatigue cracking of the fuselage skin of the crown skin panel, which could result in pressure venting and consequent rapid decompression of the airplane.
Comply with this AD within the compliance times specified, unless already done.
Do the applicable inspections required by paragraphs (g)(1), (g)(2), and (g)(3) of this AD.
(1) For all airplanes: At the applicable time specified in table 1 of paragraph 1.E., “Compliance,” of Boeing Special Attention Service Bulletin 757-53-0097, Revision 2, dated July 28, 2015: Do the inspection specified in paragraph (g)(1)(i) or (g)(1)(ii) of this AD in accordance with the Accomplishment Instructions of Boeing Special Attention Service Bulletin 757-53-0097, Revision 2, dated July 28, 2015. Repeat the inspection thereafter at the applicable times specified in table 1 of paragraph 1.E., “Compliance,” of Boeing Special Attention Service Bulletin 757-53-0097, Revision 2, dated July 28, 2015. Accomplishing the preventative modification specified in paragraph (j)(1) of this AD or the replacement specified in paragraph (j)(2) of this AD terminates the inspections required by this paragraph.
(i) Do an external sliding probe eddy current (EC) inspection for cracking of the crown skin panel at stringers S-4L (left) and S-4R (right).
(ii) Do an external spot-probe-medium-frequency EC inspection for cracking of the crown skin panel at stringers S-4L and S-4R.
(2) For airplanes on which any crack is found during any inspection required by paragraph (g)(1) of this AD; or any repair is installed that covers the Zone 1 inspection area specified in Boeing Special Attention Service Bulletin 757-53-0097, Revision 2, dated July 28, 2015; or any preventive modification is installed as specified in Part 3 of the Accomplishment Instructions of Boeing Special Attention Service Bulletin 757-53-0097, Revision 2, dated July 28, 2015: At the applicable time specified in table 2 of paragraph 1.E., “Compliance,” of Boeing Special Attention Service Bulletin 757-53-0097, Revision 2, dated July 28, 2015, except as required by paragraph (k)(1) of this AD: Do the inspection specified in paragraph (g)(2)(i) or (g)(2)(ii) of this AD, in accordance with the Accomplishment Instructions of Boeing Special Attention Service Bulletin 757-53-0097, Revision 2, dated July 28, 2015. Repeat the inspection thereafter at the applicable times specified in table 2 of paragraph 1.E., “Compliance,” of Boeing Special Attention Service Bulletin 757-53-0097, Revision 2, dated July 28, 2015. Accomplishing the replacement specified in paragraph (j)(2) of this AD terminates the inspections required by this paragraph.
(i) Do an external sliding probe EC inspection for cracking of the crown skin panel at stringers S-2L, S-3L, and S-3R, as applicable.
(ii) Do an external spot-probe-medium-frequency EC inspection for cracking of the crown skin panel at stringers S-2L, S-3L, and S-3R, as applicable.
(3) For airplanes on which any crack is found during any inspection required by paragraph (g)(1) of this AD; or any repair is installed that covers the Zone 1 inspection area specified in Boeing Special Attention Service Bulletin 757-53-0097, Revision 2, dated July 28, 2015; or any preventive modification is installed as specified in Part 3 of the Accomplishment Instructions of Boeing Special Attention Service Bulletin 757-53-0097, Revision 2, dated July 28, 2015: At the applicable time specified in table 3 of paragraph 1.E., “Compliance,” of Boeing Special Attention Service Bulletin 757-53-0097, Revision 2, dated July 28, 2015, except as required by paragraph (k)(1) of this AD: Do the inspection specified in paragraph (g)(3)(i) or (g)(3)(ii) of this AD, in accordance with the Accomplishment Instructions of Boeing Special Attention Service Bulletin 757-53-0097, Revision 2, dated July 28, 2015. Repeat the inspection thereafter at the applicable times specified in table 3 of paragraph 1.E., “Compliance,” of Boeing Special Attention Service Bulletin 757-53-0097, Revision 2, dated July 28, 2015. Accomplishing the replacement specified in paragraph (j)(2) of this AD terminates the inspections required by this paragraph.
(i) Do an external sliding probe EC inspection for cracking of the crown skin panel at stringers S-3L and S-3R.
(ii) Do an external spot-probe-medium-frequency EC inspection for cracking of the crown skin panel at stringers S-3L and S-3R.
For airplanes on which a preventive modification has been installed as specified in Part 3 of the Accomplishment Instructions of Boeing Special Attention Service Bulletin 757-53-0097, Revision 2, dated July 28, 2015: At the applicable time specified in table 4 of paragraph 1.E., “Compliance,” of Boeing Special Attention Service Bulletin 757-53-0097, Revision 2, dated July 28, 2015; do eddy current and detailed inspections for cracking of the applicable areas of the fuselage skin of the doublers, triplers, and fillers of the preventive modification, in accordance with the Accomplishment Instructions of Boeing Special Attention Service Bulletin 757-53-0097, Revision 2, dated July 28, 2015. Repeat the inspection thereafter at the applicable times specified in table 4 of paragraph 1.E., “Compliance,” of Boeing Special Attention Service Bulletin 757-53-0097, Revision 2, dated July 28, 2015.
If any cracking is found during any inspection required by paragraph (g)(1), (g)(2), (g)(3), or (h) of this AD, repair before further flight using a method approved in accordance with the procedures specified in paragraph (m) of this AD. Doing the repair ends the repetitive inspections for the repaired area only.
(1) Accomplishing the preventative modification, including doing high frequency EC inspections for cracking around existing fastener holes, in accordance with Part 3 of the Accomplishment Instructions of Boeing Special Attention Service Bulletin 757-53-0097, Revision 2, dated July 28, 2015, except
(2) Replacing the crown skin panel between STA 297 and STA 439, S-4L to S-4R, using a method approved in accordance with the procedures specified in paragraph (m) of this AD, terminates the inspections required by paragraphs (g)(1), (g)(2), and (g)(3) of this AD.
(1) Where Boeing Special Attention Service Bulletin 757-53-0097, Revision 2, dated July 28, 2015, specifies a compliance time “after the Revision 2 date of this service bulletin,” this AD requires compliance within the specified compliance time after the effective date of this AD.
(2) Where Boeing Special Attention Service Bulletin 757-53-0097, Revision 2, dated July 28, 2015, specifies to contact Boeing for repair instructions: Before further flight, repair using a method approved in accordance with the procedures specified in paragraph (m) of this AD.
(3) If any cracking is found during any inspection specified in paragraph (j)(1) of this AD, before further flight, repair using a method approved in accordance with the procedures specified in paragraph (m) of this AD.
(1) This paragraph provides credit for Zone 1 inspections required by paragraph (g) of this AD, if those actions were performed before the effective date of this AD using Boeing Special Attention Service Bulletin 757-53-0097, dated November 22, 2010, which was incorporated by reference in AD 2011-01-15, Amendment 39-16572 (76 FR 1351, January 10, 2011).
(2) This paragraph provides credit for the Zone 1 inspection required by paragraph (g) of this AD, if those actions were performed before the effective date of this AD, using Boeing Special Attention Service Bulletin 757-53-0097, Revision 1, dated January 6, 2011, which is not incorporated by reference in this AD.
(1) The Manager, Los Angeles Aircraft Certification Office (ACO), 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 ACO, send it to the attention of the person identified in paragraph (m)(1) of this AD. Information may be emailed to:
(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, Los Angeles ACO, to make those findings. For a repair method 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) AMOCs approved for AD 2011-01-15, Amendment 39-16572 (76 FR 1351, January 10, 2011), are not approved as AMOCs for the corresponding provisions of paragraph (g) of this AD.
(5) For service information that contains steps that are labeled as Required for Compliance (RC), the provisions of paragraphs (m)(5)(i) and (m)(5)(ii) 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. 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.
(1) For more information about this AD, contact Eric Schrieber, Aerospace Engineer, Airframe Branch, ANM-120L, FAA, Los Angeles Aircraft Certification Office (ACO), 3960 Paramount Boulevard, Lakewood, CA 90712-4137; phone: 562-627-5348; fax: 562-627-5210; email:
(2) For service information identified in this AD, contact Boeing Commercial Airplanes, Attention: Data & Services Management, 3855 Lakewood Boulevard, MC D800-0019, Long Beach, CA 90846-0001; telephone: 206-544-5000, extension 2; fax: 206-766-5683; Internet
Federal Aviation Administration (FAA), DOT.
Notice of proposed rulemaking (NPRM).
We propose to adopt a new airworthiness directive (AD) for certain Airbus Model A330-200 and -300 series airplanes; and Model A340-200 and -300 series airplanes. This proposed AD was prompted by a determination that the compliance times for certain post-repair inspections and certain allowable damage limits (ADLs) must be reduced in order to address fatigue. This proposed AD would require identifying any repairs and ADLs used to assess or control any structural damage on certain structural areas, and corrective action if necessary. We are proposing this AD to prevent fatigue damage on primary structure and structural repairs, which could result in reduced structural integrity of the airplane.
We must receive comments on this proposed AD by April 4, 2016.
You may send comments, using the procedures found in 14 CFR 11.43 and 11.45, by any of the following methods:
•
•
•
•
For service information identified in this NPRM, contact Airbus SAS, Airworthiness Office—EAL, 1 Rond Point Maurice Bellonte, 31707 Blagnac Cedex, France; telephone: +33 5 61 93 36 96; fax: +33 5 61 93 45 80; email:
You may examine the AD docket on the Internet at
Vladimir Ulyanov, Aerospace Engineer, International Branch, ANM-116, Transport Airplane Directorate, FAA, 1601 Lind Avenue SW., Renton, WA 98057-3356; telephone: 425-227-1138; fax: 425-227-1149.
We invite you to send any written relevant data, views, or arguments about this proposed AD. Send your comments to an address listed under the
We will post all comments we receive, without change, to
The European Aviation Safety Agency (EASA), which is the Technical Agent for the Member States of the European Union, has issued EASA AD 2015-0101R1, dated June 12, 2015 (referred to after this as the Mandatory Continuing Airworthiness Information, or “the MCAI”), to correct an unsafe condition for certain Airbus Model A330-200 and -300 series airplanes; and Model A340-200 and -300 series airplanes. The MCAI states:
Result of a fleet survey accomplished in 2008 identified that the nature of flight missions of A330 and A340-200/300 fleets had significantly changed in comparison with assumed usage during the type certification. Consequently, it was decided to recalculate the Structural Repair Manual (SRM) fatigue values to ensure that the given threshold and intervals remain valid.
The results of this recalculation identified reduced thresholds and intervals applicable for repairs and Allowable Damage Limits (ADL) affecting the following areas:
Failing to apply the reduced thresholds and intervals, could adversely affect the structural integrity of the aeroplane.
To address this unsafe condition, Airbus issued SRM revision dated April 2013 and temporary revision (TR) 53-001 for the STGR9 junction between FR10 and FR13 area (and subsequent revisions) to introduce reduced thresholds and intervals for the affected ADLs and repairs and issued a set of Service Bulletins (SB) to identify the ADLs used and repairs made, as well as to enable operators to update aeroplane repair records.
Consequently EASA issued AD * * *, to require identification of any repairs and/or ADL used to assess or control any structural damage on certain structural areas and, depending on findings, accomplishment of corrective action(s) [including revising the maintenance or inspection program as applicable to incorporate revised thresholds and intervals and repair].
Since that [EASA] AD was issued, data review confirmed that A330 freighter versions are not affected by the unsafe condition.
This [EASA] AD is revised to remove A330-223F and A330-243F from the Applicability.
You may examine the MCAI in the AD docket on the Internet at
Airbus has issued the following service information. The service information describes procedures for updating the airplane repair records with revised thresholds and intervals.
• Airbus Service Bulletin A330-53-3232, dated November 4, 2014.
• Airbus Service Bulletin A330-53-3233, dated September 26, 2014.
• Airbus Service Bulletin A330-53-3234, dated December 8, 2014.
• Airbus Service Bulletin A330-53-3235, Revision 01, dated January 14, 2015.
• Airbus Service Bulletin A340-53-4222, dated November 25, 2014.
• Airbus Service Bulletin A340-53-4223, dated September 26, 2014.
• Airbus Service Bulletin A340-53-4224, dated December 15, 2014.
• Airbus Service Bulletin A340-53-4225, Revision 01, dated January 14, 2015.
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
This product has been approved by the aviation authority of another country, and is approved for operation in the United States. Pursuant to our bilateral agreement with the State of Design Authority, we have been notified of the unsafe condition described in the MCAI and service information referenced above. We are proposing this AD because we evaluated all pertinent information and determined an unsafe condition exists and is likely to exist or develop on other products of these same type designs.
We estimate that this proposed AD affects 95 airplanes of U.S. registry. We also estimate that it would take about 2 work-hours per product to comply with the basic requirements of this proposed AD. The average labor rate is $85 per work-hour. Based on these figures, we estimate the cost of this proposed AD on U.S. operators to be $16,150, or $170 per product.
We have received no definitive data that would enable us to provide cost estimates for the on-condition actions specified in this proposed AD.
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
We determined that this proposed AD would not have federalism implications under Executive Order 13132. This proposed AD would 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 this proposed regulation:
1. Is not a “significant regulatory action” under Executive Order 12866;
2. Is not a “significant rule” under the 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.
Air transportation, Aircraft, Aviation safety, Incorporation by reference, Safety.
Accordingly, under the authority delegated to me by the Administrator, the FAA proposes to amend 14 CFR part 39 as follows:
49 U.S.C. 106(g), 40113, 44701.
We must receive comments by April 4, 2016.
None.
This AD applies to the airplanes, certificated in any category, identified in paragraphs (c)(1) and (c)(2) of this AD; manufacturer serial numbers (MSNs) 1 through 1,600 inclusive.
(1) Airbus Model A330-201, -202, -203, -223, -243, -301, -302, -303, -321, -322, -323, -341, -342, and -343 airplanes.
(2) Airbus Model A340-211, -212, -213, -311, -312, and -313 airplanes.
Air Transport Association (ATA) of America Code 53, Fuselage.
This AD was prompted by a determination that the compliance times for certain post-repair inspections and certain allowable damage limits (ADLs) must be reduced in order to address fatigue. We are issuing this AD to prevent fatigue damage on primary structure and structural repairs, which could result in reduced structural integrity of the airplane.
Comply with this AD within the compliance times specified, unless already done.
At the applicable times in table 1 to paragraph (g) of this AD, review the airplane maintenance records to identify any structural repair manual (SRM) ADLs used to assess or control any structural damage or any structural repair accomplished as specified in an SRM, as applicable, that have been applied on the areas as specified in table 2 to paragraph (g) of this AD.
If, during any review required by paragraph (g) of this AD, it is determined that an SRM ADL was used on an area specified in table 2 to paragraph (g) of this AD to assess or control any structural damage, or any structural repair of an area specified in table 2 to paragraph (g) of this AD was accomplished as specified in the instructions of the applicable SRM revision, dated before April 2013 or SRM temporary revision (TR) dated before November 28, 2014: Within the applicable compliance time specified in table 1 to paragraph (g) of this AD, do the actions specified in paragraph (h)(1) or (h)(2) of this AD, as applicable.
(1) Revise the maintenance or inspection program, as applicable, with the applicable revised thresholds and intervals for the identified structural repairs embodied on the airplane, and accomplish all updated inspections, in accordance with the Accomplishment Instructions of the applicable service information identified in table 2 to paragraph (g) of this AD, except as required by paragraphs (h)(1)(i) and (h)(1)(ii) of this AD.
(i) Where the applicable Airbus service information identified in table 2 to paragraph (g) of this AD specifies to contact Airbus for specific assessment, revise the maintenance or inspection program and accomplish all updated inspections, as applicable, using a method approved by the Manager, International Branch, ANM-116, Transport Airplane Directorate, FAA; or the European Aviation Safety Agency (EASA); or Airbus's EASA Design Organization Approval (DOA).
(ii) Where the Airbus applicable service information identified in table 2 to paragraph (g) of this AD specifies “current SRM,” no SRM revision dated before April 2013 or SRM TR dated before November 28, 2014, is considered a “current SRM.”
(2) For any repair that was previously allowed in any revision of the Airbus A330 or A340 SRM, as applicable, dated before April 2013; or in any SRM TR dated before November 28, 2014, to the applicable SRM: Make an assessment using a method approved by the Manager, International Branch, ANM-116, Transport Airplane Directorate, FAA; or the EASA; or Airbus's EASA DOA and perform necessary corrective actions at the applicable times identified therein.
As of the effective date of this AD, for any structural damage in the areas identified in table 2 to paragraph (g) of this AD that has exceeded the ADL, no repair or replacement may be done using an Airbus A330 or A340 SRM dated before April 2013, or any SRM TR dated before November 28, 2014.
The following provisions also apply to this AD:
(1)
(2)
(3)
(1) Refer to Mandatory Continuing Airworthiness Information (MCAI) EASA AD
(2) For service information identified in this AD, contact Airbus SAS, Airworthiness Office—EAL, 1 Rond Point Maurice Bellonte, 31707 Blagnac Cedex, France; telephone: +33 5 61 93 36 96; fax: +33 5 61 93 45 80; email:
Federal Aviation Administration (FAA), DOT.
Notice of proposed rulemaking (NPRM).
We propose to adopt a new airworthiness directive (AD) for all The Boeing Company Model 777 airplanes. This proposed AD was prompted by a report of an incident involving a landing in which the pilots needed to input corrections due to airplane yaw and roll to the right; the main landing gear (MLG) aft trunnion pin was later found to be fractured. This proposed AD would require identification and replacement of certain MLG aft trunnion pins. We are proposing this AD to prevent a fractured MLG aft trunnion pin, which could result in collapse of the MLG and consequent loss of control of the airplane during landing.
We must receive comments on this proposed AD by April 4, 2016.
You may send comments, using the procedures found in 14 CFR 11.43 and 11.45, by any of the following methods:
•
•
•
•
For service information identified in this NPRM, contact Boeing Commercial Airplanes, Attention: Data & Services Management, P.O. Box 3707, MC 2H-65, Seattle, WA 98124-2207; telephone: 206-544-5000, extension 1; fax: 206-766-5680; Internet
You may examine the AD docket on the Internet at
Narinder Luthra, Aerospace Engineer, Airframe Branch, ANM-120S, FAA, Seattle Aircraft Certification Office (ACO), 1601 Lind Avenue SW., Renton, WA 98057-3356; phone: 425-917-6513; fax: 415-917-6590; email:
We invite you to send any written relevant data, views, or arguments about this proposal. Send your comments to an address listed under the
We will post all comments we receive, without change, to
We have received a report of an incident involving a landing in which the pilots needed to input corrections due to airplane yaw and roll to the right; the MLG aft trunnion pin was later found to be fractured. Other damage included minor damage to the gear beam and trunnion door panel and a broken tie rod. Analysis of the fractured pin showed that the crack started from an area of heat damage introduced during manufacturing. A review of gear overhaul records indicated that other pins manufactured by the same supplier had similar signs of heat damage, suspected to have been caused by abusive chrome grinding. This evidence suggests that the heat damage occurred during manufacturing, so it is possible that other airplanes have aft trunnion pins with similar heat damage. This condition, if not corrected, could result in collapse of the MLG and consequent loss of control of the airplane during landing.
We reviewed Boeing Alert Service Bulletin 777-32A0103, Revision 1, dated December 10, 2015. The service information describes procedures for identifying and replacing certain MLG aft trunnion pins. 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
We are proposing this AD because we evaluated all the relevant information and determined the unsafe condition described previously is likely to exist or develop in other products of the same type design.
This proposed AD would require accomplishing the actions specified in the service information described previously.
Boeing Alert Service Bulletin 777-32A0103, Revision 1, dated December 10, 2015, limits the effectivity to Model 777 airplanes, line numbers 1 through 1330 inclusive. However, this proposed AD does not propose to limit the applicability to those line numbers. The applicability of this proposed AD includes all The Boeing Company Model 777-200, 777-200LR, 777-300, 777-300ER, and 777F series airplanes. Because the affected trunnion pins are rotable parts, we have determined that these parts could later be installed on airplanes that were initially delivered with acceptable pins, thereby subjecting those airplanes to the unsafe condition. This difference has been coordinated with Boeing.
The FAA worked in conjunction with industry, under the Airworthiness Directive Implementation Aviation Rulemaking Committee (ARC), to enhance the AD system. One enhancement was a new process for annotating which steps in the service information are required for compliance with an AD. Differentiating these steps from other tasks in the service information is expected to improve an owner's/operator's understanding of crucial AD requirements and help provide consistent judgment in AD compliance. The steps identified as Required for Compliance (RC) in any service information identified previously have a direct effect on detecting, preventing, resolving, or eliminating an identified unsafe condition.
For service information that contains steps that are labeled as RC, the following provisions apply: (1) 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, and an AMOC is required for any deviations to RC steps, including substeps and identified figures; and (2) 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.
We estimate that this proposed AD affects 123 airplanes of U.S. registry.
We estimate the following costs to comply with this proposed AD:
We estimate the following costs to do any necessary replacements that would be required based on the results of the proposed inspection. We have no way of determining the number of aircraft that might need this repair:
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.
We determined that this proposed AD would not have federalism implications under Executive Order 13132. This proposed AD would 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 this proposed regulation:
(1) Is not a “significant regulatory action” under Executive Order 12866,
(2) Is not a “significant rule” under the 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.
Air transportation, Aircraft, Aviation safety, Incorporation by reference, Safety.
Accordingly, under the authority delegated to me by the Administrator, the FAA proposes to amend 14 CFR part 39 as follows:
49 U.S.C. 106(g), 40113, 44701.
We must receive comments by April 4, 2016.
None.
This AD applies to all The Boeing Company Model 777-200, 777-200LR, 777-300, 777-300ER, and 777F series airplanes, certificated in any category.
Air Transport Association (ATA) of America Code 32, Landing gear.
This AD was prompted by a report of an incident involving a landing in which the pilots needed to input corrections due to airplane yaw and roll to the right; the main landing gear (MLG) aft trunnion pin was later found to be fractured. We are issuing this AD to prevent a fractured MLG aft trunnion pin, which could result in collapse of the MLG and consequent loss of control of the airplane during landing.
Comply with this AD within the compliance times specified, unless already done.
Within 36 months after the effective date of this AD, identify the serial number and marking of the MLG aft trunnion pins, in accordance with Part 1 of the Accomplishment Instructions of Boeing Alert Service Bulletin 777-32A0103, Revision 1, dated December 10, 2015.
For any MLG aft trunnion pin that begins with serial number “EGL” or “MAL,” on which no “BASE METAL INSPECTED” marking is found, replace with a new or serviceable MLG aft trunnion pin within 36 months after the effective date of this AD, in accordance with Part 2 of the Accomplishment Instructions of Boeing Alert Service Bulletin 777-32A0103, Revision 1, dated December 10, 2015.
As of the effective date of this AD, no person may install, on any airplane, any MLG aft trunnion pin that begins with serial number “EGL” or “MAL” and is not marked “BASE METAL INSPECTED.”
(1) This paragraph provides credit for the actions specified in paragraph (g) of this AD, if those actions were performed before the effective date of this AD using Boeing Multi-Operator Message (MOM) MOM-MOM15-0303-01B, dated May 13, 2015, which is not incorporated by reference in this AD.
(2) This paragraph provides credit for the actions specified in paragraphs (g) and (h) of this AD, if those actions were performed before the effective date of this AD using Boeing Alert Service Bulletin 777-32A0103, dated September 11, 2015, which is not incorporated by reference in this AD.
(1) The Manager, Seattle Aircraft Certification Office (ACO), 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 ACO, send it to the attention of the person identified in paragraph (l)(1) of this AD. Information may be emailed to:
(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, 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 (k)(4)(i) and (k)(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. 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.
(1) For more information about this AD, contact Narinder Luthra, Aerospace Engineer, Airframe Branch, ANM-120S, FAA, Seattle ACO, 1601 Lind Avenue SW., Renton, WA 98057-3356; phone: 425-917-6513; fax: 415-917-6590; email:
(2) For service information identified in this AD, contact Boeing Commercial Airplanes, Attention: Data & Services Management, P.O. Box 3707, MC 2H-65, Seattle, WA 98124-2207; telephone: 206-544-5000, extension 1; fax: 206-766-5680; Internet
Federal Aviation Administration (FAA), DOT.
Notice of proposed rulemaking (NPRM).
We propose to adopt a new airworthiness directive (AD) for all Fokker Services B.V. Model F.28 Mark 0070 and 0100 airplanes. This proposed AD was prompted by the need for more restrictive airworthiness limitations. This proposed AD would require revising the maintenance program or inspection program, as applicable, to incorporate certain maintenance requirement tasks, thresholds, and intervals. We are proposing this AD to reduce the potential for significant failure conditions and consequent loss of controllability of the airplane.
We must receive comments on this proposed AD by April 4, 2016.
You may send comments, using the procedures found in 14 CFR 11.43 and 11.45, by any of the following methods:
•
•
•
•
For service information identified in this NPRM, contact Fokker Services B.V., Technical Services Dept., P.O. Box 1357, 2130 EL Hoofddorp, the Netherlands; telephone +31 (0)88-6280-
You may examine the AD docket on the Internet at
Tom Rodriguez, Aerospace Engineer, International Branch, ANM-116, Transport Airplane Directorate, FAA, 1601 Lind Avenue SW., Renton, WA 98057-3356; telephone 425-227-1137; fax 425-227-1149.
We invite you to send any written relevant data, views, or arguments about this proposed AD. Send your comments to an address listed under the
We will post all comments we receive, without change, to
The European Aviation Safety Agency (EASA), which is the Technical Agent for the Member States of the European Union, has issued EASA Airworthiness Directive 2015-0027, dated February 20, 2015 (referred to after this as the Mandatory Continuing Airworthiness Information, or “the MCAI”), to correct an unsafe condition for all Fokker Services B.V. Model F.28 Mark 0070 and 0100 airplanes. The MCAI states:
Fokker Services published issue 11 of Engineering Report SE-473, containing Certification Maintenance Requirements (CMRs). This report is Part 1 of the Airworthiness Limitations Section (ALS Part 1) of the Instructions for Continued Airworthiness, referred to in Section 06, Appendix 1, of the Fokker 70/100 Maintenance Review Board (MRB) document.
The complete ALS currently consists of:
Part 1—Report SE-473 (CMRs), Part 2—Report SE-623, Airworthiness Limitation Items (ALIs) and Safe Life Items (SLIs), and Part 3—Report SE-672, Fuel ALIs and Critical Design Configuration Control Limitations (CDCCLs).
The instructions contained in those reports have been identified as mandatory actions for continued airworthiness.
For the reasons described above, this [EASA] AD requires implementation of the maintenance actions as specified in ALS Part 1 of the Instructions for Continued Airworthiness, Fokker Services Engineering Report SE-473 at issue 11.
You may examine the MCAI in the AD docket on the Internet at
Fokker Services B.V. has issued Engineering Report, Airworthiness Limitations Section (ALS), “Fokker 70/100 Certification Maintenance Requirements,” of Fokker Services B.V. Engineering Report SE-473, Issue 11, released January 19, 2015. This service information describes certification maintenance requirements. 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
This product has been approved by the aviation authority of another country, and is approved for operation in the United States. Pursuant to our bilateral agreement with the State of Design Authority, we have been notified of the unsafe condition described in the MCAI and service information referenced above. We are proposing this AD because we evaluated all pertinent information and determined an unsafe condition exists and is likely to exist or develop on other products of these same type designs.
This proposed AD would require revisions to certain operator maintenance documents to include new actions (
The MCAI specifies that if there are findings from the ALS inspection tasks, corrective actions must be accomplished in accordance with Fokker Services B.V. maintenance documentation or by contacting Fokker Services B.V. for repair instructions, and provides for varying compliance times for the corrective actions depending on the inspection findings. However, this proposed AD does not include that requirement. Operators of U.S.-registered airplanes are required by general airworthiness and operational regulations to perform all maintenance before further flight using methods that are acceptable to the FAA. We consider those methods to be adequate to address any corrective actions necessitated by the findings of ALS inspections required by this proposed AD.
We estimate that this proposed AD affects 8 airplanes of U.S. registry.
We also estimate that it would take about 1 work-hour per product to comply with the basic requirements of this proposed AD. The average labor rate is $85 per work-hour. Based on these figures, we estimate the cost of this proposed AD on U.S. operators to be $680, or $85 per product.
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
We determined that this proposed AD would not have federalism implications under Executive Order 13132. This proposed AD would 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 this proposed regulation:
1. Is not a “significant regulatory action” under Executive Order 12866;
2. Is not a “significant rule” under the 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.
Air transportation, Aircraft, Aviation safety, Incorporation by reference, Safety.
Accordingly, under the authority delegated to me by the Administrator, the FAA proposes to amend 14 CFR part 39 as follows:
49 U.S.C. 106(g), 40113, 44701.
We must receive comments by April 4, 2016.
None.
This AD applies to Fokker Services B.V. Model F.28 Mark 0070 and 0100 airplanes, certificated in any category, all serial numbers.
Air Transport Association (ATA) of America Code 05, Time Limits/Maintenance Checks.
This AD was prompted by the need for more restrictive airworthiness limitations. We are issuing this AD to reduce the potential for significant failure conditions and consequent loss of controllability of the airplane.
Comply with this AD within the compliance times specified, unless already done.
(1) Within 12 months after the effective date of this AD, revise the maintenance or inspection program, as applicable, to incorporate the certification maintenance requirements (CMR) specified in Fokker Services B.V. Engineering Report, Airworthiness Limitations Section (ALS), “Fokker 70/100 Certification Maintenance Requirements,” of Fokker Services B.V. Engineering Report SE-473, Issue 11, released January 19, 2015.
(2) Do the applicable initial CMR inspection at the time specified in paragraph (g)(2)(i) or (g)(2)(ii) of this AD, as applicable, as specified in Fokker Services B.V. Engineering ALS, “Fokker 70/100 Certification Maintenance Requirements,” Fokker Services B.V. Engineering Report SE-473, Issue 11, released January 19, 2015. If any discrepancy is found during any inspection, repair using a method approved by the Manager, International Branch, ANM-116, Transport Airplane Directorate, FAA; or the European Aviation Safety Agency; or Fokker B.V. Service's EASA Design Organization Approval (DOA). Repair any discrepancy before further flight.
(i) For CMR inspection 783100-CM-01: Within 1 year or 3,000 flight hours after the effective date of this AD, whichever occurs first, but not later than 12,000 flight hours after accomplishing MRB task 783100-00-04.
(ii) For CMR inspection 783500-CM-01: Within 1 year or 3,000 flight hours after the effective date of this AD, whichever occurs first, but not later than 10,000 flight hours after accomplishing MRB task 783100-01-01.
After accomplishment of the actions specified in paragraph (g)(2) of this AD, no alternative actions (
The following provisions also apply to this AD:
(1)
(2)
(1) Refer to MCAI EASA Airworthiness Directive 2015-0027, dated February 20, 2015, for related information. This MCAI may be found in the AD docket on the Internet at
(2) For service information identified in this AD, contact Fokker Services B.V., Technical Services Dept., P.O. Box 1357, 2130 EL Hoofddorp, the Netherlands; telephone +31 (0)88-6280-350; fax +31 (0)88-6280-111; email
Coast Guard, DHS.
Notice of proposed rulemaking.
The Coast Guard proposes to modify the operating schedule that governs the 63rd Street Bridge across Indian Creek, mile 4.0, at Miami Beach, FL. This proposed rule implements restrictions that allow the bridge to not open for vessels during peak vehicle traffic times. Bridge openings during peak vehicle traffic times cause major traffic jams that may be avoided without negatively impacting vessel traffic on the Indian Creek. Modifying the bridge operating schedule will reduce major vehicle traffic issues during rush hour times.
Comments and related material must reach the Coast Guard on or before April 18, 2016.
You may submit comments identified by docket number USCG-2015-0940 using Federal eRulemaking Portal at
See the “Public Participation and Request for Comments” portion of the
If you have questions on this proposed rule, call or email Mr. Rod Elkins with the Coast Guard; telephone 305-415-6989, email
On March 11th, 2015 the Miami Beach City Commission held a public meeting to discuss appropriate action for modifying the bridge operations. Additionally, the City conducted traffic studies and reviewed the bridge logs which showed a 45% increase in vehicular traffic from 7 a.m. to 10 a.m. and 4 p.m. to 7 p.m. with no corresponding increase in vessel traffic during those time periods. Input from the public meeting and the traffic data was used to develop the proposed rule. That data will be included in the electronic docket for this proposed rulemaking.
63rd Street Bridge across Indian Creek, mile 4.0, at Miami Beach, FL is a single leaf bascule bridge. It has a vertical clearance of 11 feet at mean high water in the closed position and a horizontal clearance of 50 feet.
Presently, in accordance with 33 CFR 117.5, the 63rd Street Bridge is required to open on signal for the passage of vessels. The City of Miami Beach and Miami Dade County determined that restricting bridge openings during peak traffic hours will significantly reduce traffic congestion. Based on this determination, the City of Miami Beach requested this action to alleviate additional traffic congestion created by bridge openings during peak hours.
In addition to proposing a schedule that will allow for limited openings during the regular work week, the Coast Guard is proposing a regulation change that will apply during the annual boat show. Every year in mid-February the City of Miami Beach hosts the Yacht and Brokerage Show which creates unusually high vehicle and vessel traffic during the weeks before and after the show. The Coast Guard typically issues temporary deviations to the 63rd Street Bridge operations that help balance vessel and vehicle needs during those times. The Coast Guard proposes adopting the annual temporary deviation as part of this bridge regulation.
The Coast Guard proposes to add a new regulation for the operations of the 63rd Street Bridge, Indian Creek mile 4.0, at Miami Beach. The proposed regulation would implement three closure periods, which would allow the bridge to not open for vessels during morning and afternoon peak vehicle traffic times. The following schedule is proposed: (1) From Monday through Friday from 7 a.m. to 7 p.m. the bridge would only open on the hour and half hour; (2) from 7:10 a.m. to 9:55 a.m. and 4:05 p.m. to 6:59 p.m. Monday through Friday, the bridge would remain closed; and (3) from 10 a.m. to 4 p.m. the seven days before and the four days following the City of Miami Beach Yacht and Brokerage Show the second week of February, the bridge would only open for ten minutes at the top of the hour. For federal holidays, weekends, and other times the bridge would continue to open for vessels on signal.
These proposed changes will still allow vessels to pass through the bridge while taking into account the reasonable needs of other modes of transportation.
We developed this proposed rule after considering numerous statutes and executive orders (E.O.s) related to rulemaking. Below we summarize our analyses based on these statutes and E.O.s and we also discuss First Amendment rights of protestors.
E.O.s 12866 and 13563 direct agencies to assess the costs and benefits of available regulatory alternatives and, if regulation is necessary, to select regulatory approaches that maximize net benefits. E.O. 13563 emphasizes the importance of quantifying both costs and benefits, of reducing costs, of harmonizing rules, and of promoting flexibility. This NPRM has not been designated a “significant regulatory action,” under E.O. 12866. Accordingly, the NPRM has not been reviewed by the Office of Management and Budget.
This regulatory action determination is based on the limited impact that it is anticipated to have on vessel traffic on the Indian Creek while taking into account the needs of vehicular traffic. Vessels that can transit under the bridge without an opening may do so. Other vessels can transit during non closure period times, and emergency vessels and tugs with tows can still request openings at any time.
The Regulatory Flexibility Act of 1980 (RFA), 5 U.S.C. 601-612, as amended, requires federal agencies to consider the potential impact of regulations on small entities during rulemaking. The term “small entities” comprises small businesses, not-for-profit organizations that are independently owned and operated and are not dominant in their fields, and governmental jurisdictions with populations of less than 50,000. The Coast Guard certifies under 5 U.S.C. 605(b) that this proposed rule would not have a significant economic impact on a substantial number of small entities. While some owners or operators of vessels intending to transit the bridge may be small entities, for the reasons stated in section IV.A above this proposed rule would not have a significant economic impact on any vessel owner or operator.
If you think that your business, organization, or governmental jurisdiction qualifies as a small entity and that this rule would have a significant economic impact on it, please submit a comment (see
Under section 213(a) of the Small Business Regulatory Enforcement Fairness Act of 1996 (Pub. L. 104-121), we want to assist small entities in understanding this proposed rule. If the rule would affect your small business, organization, or governmental jurisdiction and you have questions concerning its provisions or options for
This proposed rule would call for no new collection of information under the Paperwork Reduction Act of 1995 (44 U.S.C. 3501-3520.).
A rule has implications for federalism under Executive Order 13132, Federalism, if it has 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. We have analyzed this proposed rule under that Order and have determined that it is consistent with the fundamental federalism principles and preemption requirements described in E.O. 13132.
Also, this proposed rule does not have tribal implications under Executive Order 13175, Consultation and Coordination with Indian Tribal Governments, because it would not have a substantial direct effect on one or more Indian tribes, on the relationship between the Federal Government and Indian tribes, or on the distribution of power and responsibilities between the Federal Government and Indian tribes. If you believe this proposed rule has implications for federalism or Indian tribes, please contact the person listed in the
The Unfunded Mandates Reform Act of 1995 (2 U.S.C. 1531-1538) requires Federal agencies to assess the effects of their discretionary regulatory actions. In particular, the Act addresses actions that may result in the expenditure by a State, local, or tribal government, in the aggregate, or by the private sector of $100,000,000 (adjusted for inflation) or more in any one year. Though this proposed rule will not result in such an expenditure, we do discuss the effects of this proposed rule elsewhere in this preamble.
We have analyzed this proposed rule under Department of Homeland Security Management Directive 023-01 and Commandant Instruction M16475.lD, which guides the Coast Guard in complying with the National Environmental Policy Act of 1969 (NEPA) (42 U.S.C. 4321-4370f), and have made a preliminary determination that this action is one of a category of actions which do not individually or cumulatively have a significant effect on the human environment. This proposed rule promulgates the operating regulations or procedures for drawbridges. Normally such actions are categorically excluded from further review, under figure 2-1, paragraph (32)(e), of the Instruction.
Under figure 2-1, paragraph (32)(e), of the Instruction, an environmental analysis checklist and a categorical exclusion determination are not required for this rule. We seek any comments or information that may lead to the discovery of a significant environmental impact from this proposed rule.
The Coast Guard respects the First Amendment rights of protesters. Protesters are asked to contact the person listed in the
We view public participation as essential to effective rulemaking, and will consider all comments and material received during the comment period. Your comment can help shape the outcome of this rulemaking. If you submit a comment, please include the docket number for this rulemaking, indicate the specific section of this document to which each comment applies, and provide a reason for each suggestion or recommendation.
We encourage you to submit comments through the Federal eRulemaking Portal at
We accept anonymous comments. All comments received will be posted without change to
Documents mentioned in this notice, and all public comments, are in our online docket at
Bridges.
For the reasons discussed in the preamble, the Coast Guard proposes to amend 33 CFR part 117 as follows:
33 U.S.C. 499; 33 CFR 1.05-1; Department of Homeland Security Delegation No. 0170.1.
The draw of the 63rd Street Bridge, Indian Creek mile 4.0, at Miami Beach, shall open on signal except as follows:
(a) From 7 a.m. to 7 p.m., Monday through Friday except Federal holidays, the draw need open only on the hour and half-hour.
(b) From 7:10 a.m. to 9:55 a.m. and 4:05 p.m. to 6:59 p.m., Monday through Friday except Federal holidays, the draw need not open for the passage of vessels.
(c) In February of each year during the period seven days prior to the City of Miami Beach Yacht and Brokerage Show and the four days following the show, from 10:00 a.m. to 4:00 p.m., the bridge need not open except for 10 minutes at the top of the hour. At all other times the bridge shall operate on its normal schedule.
Federal Communications Commission.
Proposed rule.
The Commission has before it a petition for rulemaking filed by Gray Television License, LLC, proposed assignee of KDUH-TV, Scottsbluff, Nebraska and New Rushmore Radio, Inc., the licensee of station KDUH-TV, channel 7, Scottsbluff, Nebraska (collectively “Petitioners”), requesting an amendment of the DTV Table of Allotments to delete channel 7 at Scottsbluff and substitute channel 7 at Sidney, Nebraska. While the Commission instituted a freeze on the acceptance of full power television rulemaking petitions requesting channel substitutions in May 2011, Petitioners are seeking a waiver asserting that because the proposed change in community of license does not involve any proposed change in technical facilities, grant of the petition would not impact on the Post-Transition Table of DTV Allotments. Petitioners believe that a waiver here would serve the public interest and that community in Sidney would remain well-served after reallotment.
Comments must be filed on or before March 21, 2016, and reply comments on or before April 4, 2016.
Federal Communications Commission, Office of the Secretary, 445 12th Street SW., Washington, DC 20554. In addition to filing comments with the FCC, interested parties should serve counsel for petitioner as follows: Gray Television Licensee, LLC, c/o Cooley LLP, John R. Feore, Jr. Esq. and Derek Teslik, Esq., 1299 Pennsylvania Avenue NW., Suite 700, Washington, DC 20004; New Rushmore Radio Inc., c/o Law Office of Jack N. Goodman, Jack N. Goodman, Esq., 1200 New Hampshire Ave. NW., Suite 600, Washington, DC 20036.
Adrienne Y. Denysyk,
This is a synopsis of the Commission's Notice of Proposed Rule Making, MB Docket No. 16-29, adopted February 8, 2016, and released February 8, 2016. The full text of this document is available for public inspection and copying during normal business hours in the FCC's Reference Information Center at Portals II, CY-A257, 445 12th Street SW., Washington, DC 20554. This document will also be available via ECFS (
Provisions of the Regulatory Flexibility Act of 1980 do not apply to this proceeding.
Members of the public should note that from the time a Notice of Proposed Rule Making is issued until the matter is no longer subject to Commission consideration or court review, all
For information regarding proper filing procedures for comments, see 47 CFR 1.415 and 1.420.
Television.
For the reasons discussed in the preamble, the Federal Communications Commission proposes to amend 47 CFR part 73 as follows:
47 U.S.C. 154, 303, 334, 336, and 339.
Surface Transportation Board.
Proposed rule, withdrawn.
The Board is withdrawing the proposed rules and discontinuing the EP 701 rulemaking proceeding which proposed to accelerate the filing deadlines for certain financial, employee, and traffic reports submitted by Class I railroads.
The proposed rule is withdrawn and the rulemaking proceeding is discontinued on February 18, 2016.
Pedro Ramirez, (202) 245-0333. Assistance for the hearing impaired is available through the Federal Information Relay Service (FIRS) at (800) 877-8339.
On July 8, 2015, the Board issued a Notice of Proposed Rulemaking (NPRM) seeking public comment on a proposal to accelerate the filing deadlines for certain financial, employee, and traffic reports submitted by Class I railroads.
In the NPRM, the Board proposed changing the filing deadlines for a number of these reports. Specifically, the NPRM proposed the following deadlines: Schedule 250 would be filed by March 31 each year, at the same time as the Annual Report Form R-1; Quarterly Report Form RE&I, Form CBS, Quarterly Wage Forms A & B, and Reports of Fuel Cost, Consumption, and Surcharge Revenue would be filed within 15 days after the end of each quarter; Annual Wage Forms A & B and Annual Form QCS would be filed 30 days after the end of each year; Quarterly Form QCS would be filed 30 days after the end of each quarter; Form STB-54 would be filed within 60 days after the end of each year; and Form C would be filed 10 days after the end of each month.
The NPRM also proposed to: Update several form titles; clarify the method by which carriers arrive at the number of employees reported on Form C, pursuant to part 1246; replace references to the “Interstate Commerce Act” with “pt. A of subtitle IV of tit. 49, United States Code” between 49 CFR parts 1241 and 1248 to accurately describe the current controlling statute; and eliminate the requirement of railroads to file duplicate copies of reports, with the exception of the Annual Report Form R-1, which requires hard copies to be filed.
On August 21, 2015, the AAR filed comments on the proposed rules. AAR expresses concern that the proposed accelerated deadlines would impose significant burdens while not conferring a public benefit. (AAR Comment 7.) AAR states that the proposed deadlines for the STB reports would be incompatible with and would create additional reporting obligations for the railroads under Securities and Exchange Commission (SEC) regulations. (
Based on AAR's comments, the proposed rules could impose a significant burden on the railroads and conflict with SEC reporting requirements. No other comments were submitted. Therefore, we will not adopt the proposed accelerated deadlines and will discontinue this proceeding.
However, some of the nonsubstantive updates that the Board proposed will be adopted in
This action will not significantly affect either the quality of the human environment or the conservation of energy resources.
Decided: February 11, 2016.
By the Board, Chairman Elliott, Vice Chairman Miller, and Commissioner Begeman.
A public hearing has been scheduled for February 24, 2016, at 9:30 a.m., on the application for additional production authority submitted by The Coleman Company, Inc., for activity within Subzone 119I in Sauk Rapids, Minnesota (see 80 FR 79820, December 23, 2015). The location for the hearing has been changed to Room 48019, U.S. Department of Commerce, Hoover Building, 1401 Constitution Avenue NW., Washington, DC 20230.
For further information, contact Pierre Duy at
Enforcement and Compliance, International Trade Administration, Department of Commerce.
In response to a request from Nucor Corporation and SSAB Enterprises LLC (collectively “Domestic Producers”), the Department of Commerce (“Department”) is initiating a circumvention inquiry, pursuant to section 781(c) of the Tariff Act of 1930, as amended (the “Act”), to determine whether certain imports of certain cut-to-length carbon steel plate (“CTL plate”) are circumventing the antidumping duty order on CTL plate from the People's Republic of China (“PRC”).
Patrick O'Connor or Thomas Martin, AD/CVD Operations, Office IV, Enforcement & Compliance, International Trade Administration, U.S. Department of Commerce, 14th Street and Constitution Avenue NW., Washington, DC 20230; telephone: (202) 482-0989, and (202) 482-3936, respectively.
On June 17, 2015, Domestic Producers requested that the Department make a final circumvention ruling within 45 days pursuant to 19 CFR 351.225(c)(2) and (d) with respect to CTL plate from the PRC with small amounts of any alloying elements added so as to classify the steel as alloy steel under the Harmonized Tariff Schedule of the United States (“HTSUS”), regardless of exporter or importer.
Domestic Producers alleged that producers, exporters and importers are circumventing the
Domestic Producers noted that there is a history of evading the
Domestic Producers contended that PRC producers are now adding other alloying elements, in addition to boron, to otherwise subject CTL plate in order to circumvent the
On July 6, 2015, the Department identified various areas of the Domestic Producers' Request that required clarification and therefore issued questions to them.
Domestic Producers also stated that the exclusion criteria in
On August 5, 2015, Wuyang Iron and Steel Co., Ltd. (“Wuyang”) commented on Domestic Producers' First Supplemental Submission.
On August 28, 2015, the Department issued another request for information to Domestic Producers,
On November 18, 2015, the Department again issued a request for information to the Domestic Producers requesting clarification of certain previously submitted evidence and additional evidence relating to their allegation.
On January 20, 2016, Domestic Producers submitted additional business proprietary factual support for their request for a circumvention inquiry.
The product covered by the order is certain cut-to-length carbon steel plate from the PRC. Included in this description is hot-rolled iron and non-alloy steel universal mill plates (
For the reasons explained below in the “Conclusion” section of this notice, we have not initiated this circumvention inquiry on all of the products described in Domestic Producers' Request. Rather, this circumvention inquiry covers all CTL plate from the PRC made to ASTM A36 or A572 specifications with levels of chromium or titanium above the levels identified in note (f), “Other alloy steel”, of Chapter 72 of the HTSUS. This inquiry also covers all CTL plate from the PRC made to ASTM A36 or A572 specifications which contains levels of boron above the levels identified in note (f) of Chapter 72 of the HTSUS and which has not been heat treated to meet tensile and hardness requirements beyond commodity-grade ASTM specifications. This inquiry will cover U.S. imports of all CTL plate from the PRC.
Section 781(c)(1) of the Act provides that the class or kind of merchandise subject to an antidumping duty order shall include articles “altered in form or appearance in minor respects . . . whether or not included in the same tariff classification.” The Department notes that, while the statute is silent as to what factors to consider in determining whether alterations are properly considered “minor,” the legislative history of this provision indicates there are certain factors which should be considered before reaching a circumvention determination. In conducting a circumvention inquiry under section 781(c) of the Act, the Department has generally relied upon “such criteria as the overall physical characteristics of the merchandise, the expectations of the ultimate users, the use of the merchandise, the channels of marketing and the cost of any modification relative to the total value of the imported products.”
According to Domestic Producers, the CTL plate at issue is made in nearly the same manner, made to the same specifications, and has the same physical characteristics as carbon steel plate. Domestic Producers claimed that the effect of the added alloying elements is negligible.
Domestic Producers contended that the ultimate users purchasing the CTL
Domestic Producers argued that the product at issue is used for the same purposes as subject merchandise.
Domestic Producers stated that PRC producers market the CTL plate at issue in the same manner as the CTL plate without the alloying elements.
Domestic Producers claimed that the cost of adding only small amounts of alloying elements is small when compared to the total cost of production and total value of CTL plate.
Based on the information provided by Domestic Producers, the Department finds there is sufficient basis to initiate an antidumping duty circumvention inquiry, pursuant to section 781(c) of the Act, to determine whether CTL plate from the PRC made to ASTM A36 or A572 specifications with levels of chromium or titanium above the levels identified in note (f), “Other alloy steel”, of Chapter 72 of the HTSUS involves a minor alteration to subject merchandise that is so insignificant as to render the resulting merchandise (classified as “alloy” steel under the HTSUS) subject to the
Although Domestic Producers requested a circumvention inquiry with respect to all of the alloying elements identified in note (f), “Other alloy steel”, of Chapter 72 of the HTSUS, we limited initiation to the alloys noted above (chromium, titanium, and boron where there was no heat treatment) based on the evidence of alleged circumvention provided. Moreover, we have not described the merchandise subject to this inquiry as steel plate marketed, priced or sold in the United States as commodity-grade carbon steel plate or made to specifications considered to be carbon steel specifications in the market because of concerns over the administrability of that language (
Although Domestic Producers requested that the Department make a final ruling within 45 days, additional time is needed for further inquiry into Domestic Producers' allegations. The Department intends to issue its final determination within 300 days of the date of the initiation of this antidumping duty circumvention inquiry.
The Department will not order the suspension of liquidation of entries of any of the merchandise at issue at this time. However, in accordance with 19 CFR 351.225(l)(2), if the Department issues a preliminary affirmative determination, we will then instruct CBP to suspend liquidation and require a cash deposit of estimated duties, at the applicable rate, for each unliquidated entry of the merchandise at issue, entered, or withdrawn from warehouse for consumption, on or after the date of initiation of the inquiry.
The Department will establish a schedule for questionnaires and comments on the issues.
This notice is published in accordance with section 781(c) of the Act and 19 CFR 351.225(i).
National Marine Fisheries Service (NMFS), National Oceanic and Atmospheric Administration (NOAA), Commerce.
Notice; notification of quota for bowhead whales.
NMFS notifies the public of the aboriginal subsistence whaling quota for bowhead whales that it has assigned to the Alaska Eskimo Whaling Commission (AEWC), and of limitations on the use of the quota deriving from regulations of the International Whaling Commission (IWC). For 2016, the quota is 75 bowhead whales struck. This quota and other applicable limitations govern the harvest of bowhead whales by members of the AEWC.
Effective February 18, 2016.
Office for International Affairs and Seafood Inspection, National Marine Fisheries Service, 1315 East-West Highway, Silver Spring, MD 20910.
Melissa Andersen Garcia, (301) 427-8385.
Aboriginal subsistence whaling in the United States is governed by the Whaling Convention Act (WCA) (16 U.S.C. 916
At the 64th Annual Meeting of the IWC, the Commission set catch limits for aboriginal subsistence use of bowhead whales from the Bering-Chukchi-Beaufort Seas stock. The bowhead catch limits were based on a joint request by the United States and the Russian Federation, accompanied by documentation concerning the needs of two Native groups: Alaska Eskimos and Chukotka Natives in the Russian Far East.
The IWC set a 6-year block catch limit of 336 bowhead whales landed. For each of the years 2013 through 2018, the number of bowhead whales struck may not exceed 67, except that any unused portion of a strike quota from any prior year may be carried forward. No more than 15 strikes may be added to the strike quota for any one year. At the end of the 2015 harvest, there were 15 unused strikes available for carry-forward, so the combined strike quota set by the IWC for 2016 is 82 (67 + 15).
An arrangement between the United States and the Russian Federation ensures that the total quota of bowhead whales landed and struck in 2016 will not exceed the limits set by the IWC. Under this arrangement, the Russian natives may use no more than seven strikes, and the Alaska Eskimos may use no more than 75 strikes.
Through its cooperative agreement with the AEWC, NOAA has assigned 75 strikes to the Alaska Eskimos. The AEWC will in turn allocate these strikes among the 11 villages whose cultural and subsistence needs have been documented, and will ensure that its hunters use no more than 75 strikes.
The IWC regulations, as well as the NOAA regulation at 50 CFR 230.4(c), forbid the taking of calves or any whale accompanied by a calf.
NOAA regulations (at 50 CFR 230.4) contain a number of other prohibitions relating to aboriginal subsistence whaling, some of which are summarized here:
• Only licensed whaling captains or crew under the control of those captains may engage in whaling.
• Captains and crew must follow the provisions of the relevant cooperative agreement between NOAA and a Native American whaling organization.
• The aboriginal hunters must have adequate crew, supplies, and equipment to engage in an efficient operation.
• Crew may not receive money for participating in the hunt.
• No person may sell or offer for sale whale products from whales taken in the hunt, except for authentic articles of Native American handicrafts.
• Captains may not continue to whale after the relevant quota is taken, after the season has been closed, or if their licenses have been suspended. They may not engage in whaling in a wasteful manner.
National Marine Fisheries Service (NMFS), National Oceanic and Atmospheric Administration (NOAA), Commerce.
Notice of a public meeting.
The Gulf of Mexico Fishery Management Council will hold a meeting of its Standing and Special
The meeting will convene via WEBINAR on Tuesday, March 8, 2016 from 1 p.m. to 3 p.m. EST; you may register for the webinar at:
After registering, you will receive a confirmation email containing information about joining the webinar.
Morgan Kilgour, Fishery Biologist,
The Chairman will start the meeting with introductions and adoption of agenda, approval of minutes from the March 10-12, 2015 Standing, Special
The Agenda is subject to change, and the latest version along with other
The meeting will be webcast over the internet. A link to register for the webcast is available on the Council's Web site,
Although other non-emergency issues not on the agenda may come before the Scientific and Statistical Committee for discussion, in accordance with the Magnuson-Stevens Fishery Conservation and Management Act, those issues may not be the subject of formal action during this meeting. Actions of the Scientific and Statistical Committee will be restricted to those issues specifically identified in the agenda and any issues arising after publication of this notice that require emergency action under section 305(c) of the Magnuson-Stevens Fishery Conservation and Management Act, provided the public has been notified of the Council's intent to take action to address the emergency.
This meeting is physically accessible to people with disabilities. Requests for sign language interpretation or other auxiliary aids should be directed to Kathy Pereira at the Gulf Council Office (see
National Marine Fisheries Service (NMFS), National Oceanic and Atmospheric Administration (NOAA), Commerce.
Notice of a public meeting.
The Gulf of Mexico Fishery Management Council will hold a meeting of its Ad Hoc Red Snapper Charter Advisory Panel (AP).
The meeting will convene Tuesday, March 8, 2016 from 8:30 a.m. to 5 p.m., and Wednesday, March 9, 2016 from 8:30 a.m. to 12 p.m.
The meeting will take place at the Gulf of Mexico Fishery Management Council, 2203 N. Lois Avenue, Suite 1100, Tampa, FL 33607; telephone: (813) 348-1630.
Dr. Ava Lasseter, Anthropologist, Gulf of Mexico Fishery Management Council;
The items of discussion on the agenda are as follows:
Ad Hoc Red Snapper Charter Advisory Panel Agenda, Tuesday, March 8, 2016 from 8:30 a.m. to 5 p.m., and Wednesday, March 9, 2016 from 8:30 a.m. to 12 p.m.
The Agenda is subject to change, and the latest version along with other meeting materials will be posted on the Council's file server. To access the file server, the URL is
The meeting will be webcast over the Internet. A link to the ebcast will be available on the Council's Web site,
Although other non-emergency issues not on the agenda may come before the Advisory Panel for discussion, in accordance with the Magnuson-Stevens Fishery Conservation and Management Act, those issues may not be the subject of formal action during this meeting. Actions of the Advisory Panel will be restricted to those issues specifically identified in the agenda and any issues arising after publication of this notice that require emergency action under section 305(c) of the Magnuson-Stevens Fishery Conservation and Management Act, provided the public has been notified of the Council's intent to take action to address the emergency.
This meeting is physically accessible to people with disabilities. Requests for sign language interpretation or other auxiliary aids should be directed to Kathy Pereira at the Gulf Council Office (see
National Marine Fisheries Service (NMFS), National Oceanic and Atmospheric Administration (NOAA), Commerce.
Notice of public meeting and webinar/conference call.
NMFS will hold a 3-day Atlantic Highly Migratory Species (HMS) Advisory Panel (AP) meeting in March 2016. The intent of the meeting is to consider options for the conservation and management of Atlantic HMS. The meeting is open to the public.
The AP meeting and webinar will be held from 10:30 a.m. to 6 p.m. on Tuesday, March 29, 2016; from 8:30 a.m. to 6 p.m. on Wednesday, March 30, 2016; and from 8:30 a.m. to 12 p.m. on Thursday, March 31, 2016. There will be an introduction for new AP members at 9 a.m. on Tuesday, March 29, 2016.
The meeting will be held at the DoubleTree by Hilton Hotel, 8120 Wisconsin Avenue, Bethesda, MD 20814. The meeting presentations will also be available via WebEx webinar/conference call.
On Tuesday, March 29, 2016, the conference call information is phone number 1-888-566-6157; Participant Code: 5998985; and the webinar event address is:
On Wednesday, March 30, 2016, the conference call information is phone
On Thursday, March 31, 2016, the conference call information is phone number 1-800-593-9960; Participant Code: 5039500; and the webinar event address is:
Participants are strongly encouraged to log/dial in fifteen minutes prior to the meeting. NMFS will show the presentations via webinar and allow public comment during identified times on the agenda.
Guy DuBeck or Margo Schulze-Haugen at (301) 427-8503.
The Magnuson-Stevens Fishery Conservation and Management Act, 16 U.S.C. 1801
The AP has previously consulted with NMFS on: Amendment 1 to the Billfish FMP (April 1999); the HMS FMP (April 1999); Amendment 1 to the HMS FMP (December 2003); the Consolidated HMS FMP (October 2006); and Amendments 1, 2, 3, 4, 5a, 5b, 6, 7, 8, and 9 to the 2006 Consolidated HMS FMP (April and October 2008, February and September 2009, May and September 2010, April and September 2011, March and September 2012, January and September 2013, April and September 2014, March and September 2015), among other things.
The intent of this meeting is to consider alternatives for the conservation and management of all Atlantic tunas, swordfish, billfish, and shark fisheries. We anticipate discussing the upcoming Amendments 5b on dusky sharks and 10 on Essential Fish Habitat, including lemon shark aggregations off southeast Florida; reviewing implementation of Final Amendment 9 on smoothhound sharks and Final Amendment 7 on bluefin tuna management; and progress updates on the final rule to implement the electronic bluefin tuna documentation system and the various other rulemakings. We also anticipate discussing a survey of Atlantic HMS tournaments that is in development, a request from the South Atlantic Fishery Management Council to consider management changes regarding blacknose sharks, and domestic implementation of recommendations from the 2015 meeting of the International Commission for the Conservation of Atlantic Tunas. We also intend to invite other NMFS offices to provide updates on their activities relevant to HMS fisheries such as the IUU Task Force implementation and international trade, and DeepWater Horizon Pelagic Longline Project.
Additional information on the meeting and a copy of the draft agenda will be posted prior to the meeting at:
This meeting is physically accessible to people with disabilities. Requests for sign language interpretation or other auxiliary aids should be directed to Guy DuBeck at (301) 427-8503 at least 7 days prior to the meeting.
Bureau of Consumer Financial Protection.
Notice and request for comment.
In accordance with the Paperwork Reduction Act of 1995 (PRA), the Consumer Financial Protection Bureau (Bureau) is proposing a new information collection titled, “Application Process for Designation of Rural Area under Federal Consumer Financial Law.”
An emergency review has been requested in accordance with the PRA (44 U.S.C. Chapter 3507(j)). Approval by the Office of Management and Budget (OMB) has been requested by February 29, 2016. A standard PRA clearance process is also beginning. Interested persons are invited to submit comments on or before April 18, 2016.
You may submit comments, identified by the title of the information collection, OMB Control Number (see below), and docket number (see above), by any of the following methods:
•
•
•
Documentation prepared in support of this information collection request is available at
Due to the 90-day deadline, contained in the Act, if following standard PRA clearance procedures, the Bureau would be unable to meet this statutory
The Bureau requests OMB approval of this request by February 29, 2016. Contemporaneously with this request for emergency processing, the Bureau is also initiating standard clearance procedures by publishing a notice in the
Bureau of Consumer Financial Protection.
Notice and request for comment.
In accordance with the Paperwork Reduction Act of 1995 (PRA), the Consumer Financial Protection Bureau (Bureau) is requesting to renew the Office of Management and Budget (OMB) approval for an existing information collection, titled, “Loan Originator Compensation Amendment (Regulation Z).”
Written comments are encouraged and must be received on or before March 21, 2016 to be assured of consideration.
You may submit comments, identified by the title of the information collection, OMB Control Number (see below), and docket number (see above), by any of the following methods:
•
•
Documentation prepared in support of this information collection request is available at
United States Transportation Command (USTRANSCOM), DoD.
Notice.
The DoD is not proceeding with the proposed Defense Personal Property Program (DP3) Household Goods Channeling Pilot Test, as set forth in the September 8, 2015 notice (80 FR 53786). We appreciate all inputs made toward providing the information necessary to reach this conclusion.
Defense Nuclear Facilities Safety Board.
Notice of closed meeting.
Pursuant to the provisions of the Government in the Sunshine Act (5 U.S.C. 552b), and the Defense Nuclear Facilities Safety Board's (Board) regulations implementing the Government in the Sunshine Act, notice is hereby given of the Board's closed meeting described below.
3:00 p.m.-4:00 p.m., February 25, 2016.
Defense Nuclear Facilities Safety Board, 625 Indiana Avenue NW., Washington, DC 20004.
Mark Welch, General Manager, Defense Nuclear Facilities Safety Board, 625 Indiana Avenue NW., Suite 700, Washington, DC 20004-2901, (800) 788-4016. This is a toll-free number.
The meeting will be closed to the public. No participation from the public will be considered during the meeting.
National Center for Education Statistics (NCES), Department of Education (ED).
Notice.
In accordance with the Paperwork Reduction Act of 1995 (44 U.S.C. chapter 3501
Interested persons are invited to submit comments on or before April 18, 2016.
To access and review all the documents related to the information collection listed in this notice, please use
For specific questions related to collection activities, please contact Kashka Kubzdela at
The Department of Education (ED), in accordance with the Paperwork Reduction Act of 1995 (PRA) (44 U.S.C. 3506(c)(2)(A)), provides the general public and Federal agencies with an opportunity to comment on proposed, revised, and continuing collections of information. This helps the Department assess the impact of its information collection requirements and minimize the public's reporting burden. It also helps the public understand the Department's information collection requirements and provide the requested data in the desired format. ED is soliciting comments on the proposed information collection request (ICR) that is described below. The Department of Education is especially interested in public comment addressing the following issues: (1) Is this collection necessary to the proper functions of the Department; (2) will this information be processed and used in a timely manner; (3) is the estimate of burden accurate; (4) how might the Department enhance the quality, utility, and clarity of the information to be collected; and (5) how might the Department minimize the burden of this collection on the respondents, including through the use of information technology. Please note that written comments received in response to this notice will be considered public records.
National Assessment Governing Board, U.S. Department of Education.
Announcement of open and closed meetings.
This notice sets forth the agenda for the March 3-5, 2016 Quarterly Meeting of the National Assessment Governing Board (hereafter referred to as Governing Board). This notice provides information to members of the public who may be interested in attending the meeting or providing written comments on the meeting. The notice of this meeting is required under section 10(a)(2) of the Federal Advisory Committee Act (FACA).
The Quarterly Board meeting will be held on the following dates:
• March 3, 2016 from 2:30 p.m. to 6:00 p.m.
• March 4, 2016 from 8:30 a.m. to 5:00 p.m.
• March 5, 2016 from 7:30 a.m. to 12:00 p.m.
Hilton Arlington, 950 Stafford Street, Arlington, VA 22203.
Munira Mwalimu, Executive Officer/Designated Federal Official, 800 North Capitol Street NW., Suite 825, Washington, DC 20002, telephone: (202) 357-6938, fax: (202) 357-6945.
The Board is established to formulate policy for the National Assessment of Educational Progress (NAEP). The Board's responsibilities include the following: selecting subject areas to be assessed, developing assessment frameworks and specifications, developing appropriate student achievement levels for each grade and subject tested, developing standards and procedures for interstate and national comparisons, improving the form and use of NAEP, developing guidelines for reporting and disseminating results, and releasing initial NAEP results to the public.
The Board's standing committees will meet to conduct regularly scheduled work, based on agenda items planned for this quarterly Board meeting, and follow-up items as reported in the Board's committee meeting minutes available at
On March 3, 2016, the Board will meet in closed session from 2:30 p.m.-4:00 p.m. to take the 2014 NAEP Technology and Engineering Literacy (TEL) assessment for grade 8. Board members will access secure NAEP TEL items used in the 2014 TEL assessment. This part of the meeting must be conducted in closed session because the test items are secure and have not been released to the public. Public disclosure of the secure TEL items would significantly impede implementation of the NAEP assessment program if conducted in open session. Such matters are protected by exemption 9(B) of section 552b of title 5 U.S.C.
Thereafter, the Executive Committee will convene in closed session from 4:30 p.m. to 5:20 p.m., and in open session to conduct regularly scheduled work from 5:20 p.m. to 6:00 p.m. During the closed session, the Executive Committee will receive and discuss cost estimates and implications for implementing NAEP's Assessment Schedule through 2024. This meeting must be conducted in closed session because public disclosure of this information would likely have an adverse financial effect on the NAEP program by providing confidential cost details and proprietary contract costs of current contractors to the public. Discussion of this information would be likely to significantly impede implementation of a proposed agency action if conducted in open session. Such matters are protected by exemption 9(B) of section 552b of title 5 U.S.C.
On March 4, 2016, the Full Board will meet in open session from 8:30 a.m. to 10:00 a.m. The Board will review and approve the March 3-5, 2016 Board meeting agenda and meeting minutes from the November 2015 Quarterly Board meeting. This session will be followed by new Board member introductions and administration of the Oath of Office for new members. The Chairman will then deliver remarks on the Salzburg Global Seminar. Thereafter the Executive Director of the Governing Board, William Bushaw, will provide his report, followed by an update on the work of IES provided by Ruth Neild, Deputy Director for Policy and Research, IES. The NCES update will be provided by the Acting Commissioner of NCES, Peggy Carr. The Board will recess for committee meetings at 10:00 a.m. which are scheduled to take place from 10:15 a.m. to 12:45 p.m.
The Reporting and Dissemination (R&D) Committee will meet in open
The Assessment Development Committee (ADC) will meet open session from 10:15 a.m. to 10:50 a.m., and in two closed sessions from 10:50 a.m. to 12:45 p.m. During the first closed session, scheduled from 10:50 a.m. to 12:00 p.m., the ADC will review secure NAEP test questions in grades 4 and 8 for the 2019 Mathematics pilot assessment. These test questions have not been released to the public. Disclosure of the secure data would significantly impede implementation of the NAEP assessment program if conducted in open session. Such matters are protected by exemption 9(B) of section 552b of title 5 U.S.C.
During the second closed session scheduled from 12:00 p.m. to 12:45 p.m. ADC will receive an embargoed briefing on NAEP's transition to digital-based assessment (DBA). The briefing will include secure data from the 2015 DBA pilot in Reading and Mathematics, which have not been publicly released. The briefing will also include secure NAEP test questions in Reading and Mathematics at grades 4 and 8. This meeting is being conducted in closed session because the data have not been released to the public. Public disclosure of the secure data would significantly impede implementation of the NAEP assessment program if conducted in open session. Such matters are protected by exemption 9(B) of section 552b of title 5 U.S.C.
On Friday March 4, 2016, the Committee on Standards, Design and Methodology (COSDAM) will meet in open session from 10:15 a.m. to 11:20 a.m. in closed session from 11:20 a.m. to 12:25 p.m. and in open session from 12:25 p.m. to 12:45 p.m. During the first part of the closed session (11:20 a.m. to 12:05 p.m.), COSDAM will discuss information regarding analyses of the 2015 bridge studies for paper-and-pencil and digital-based assessments, and discuss secure NAEP Reading and Mathematics data. This part of the meeting must be conducted in closed session because the analysis involves the use of secure data for the NAEP Reading and Mathematics assessments on digital-based platforms. Public disclosure of secure data would significantly impede implementation of the NAEP assessment program if conducted in open session. Such matters are protected by exemption 9(B) of section 552b of title 5 U.S.C.
During the second part of the closed session from 12:05 p.m. to 12:25 p.m., COSDAM will discuss requirements for an upcoming procurement to set achievement levels on the 2017 grade 4 Writing assessment. Public disclosure of procurement sensitive data would provide an unfair advantage to potential offerors, and significantly impede implementation of the NAEP assessment program if conducted in open session. Such matters are protected by exemption 9(B) of section 552b of title 5 U.S.C.
Following the committee meetings, on March 4, the full Board will meet in closed session from 1:00 p.m. to 2:30 p.m. to receive a briefing and discuss the 2014 NAEP Technology and Engineering Literacy (TEL) Report Card for Grade 8. Results of the TEL assessment have not been released to the public. Premature disclosure of the results would significantly impede implementation of the NAEP assessment program if conducted in open session. Such matters are protected by exemption 9(B) of 552b of title 5 U.S.C.
On March 4, 2016, from 3:00 p.m. to 4:00 p.m., the Board will meet in open session to receive a briefing on STEM perspectives from the Frameworks Institute. This session will then be followed by a briefing and discussion with Hill staff on legislative matters as they pertain to education policy issues and NAEP. The March 4, 2016 session of the Board meeting will adjourn at 5:00 p.m.
On March 5, 2016, the Nominations Committee will meet in closed session from 7:30 a.m. to 8:15 a.m. to discuss the final slate of candidates for Board vacancies for terms beginning on October 1, 2016. The Nominations Committee's discussions pertain solely to internal personnel rules and practices of an agency and information of a personal nature where disclosure would constitute an unwarranted invasion of personal privacy. As such, the discussions are protected by exemptions 2 and 6 of section 552b(c) of title 5 of the United States Code.
On March 5, 2016, the full Board will meet in closed session from 8:30 a.m. to 8:50 a.m. to discuss the final slate of candidates for Board vacancies for terms beginning October 1, 2016. The Board's discussions pertain solely to internal personnel rules and practices of an agency and information of a personal nature where disclosure would constitute an unwarranted invasion of personal privacy. As such, the discussions are protected by exemptions 2 and 6 of section 552b(c) of title 5 of the United States Code.
Following this closed session, the full Board will meet in open session from 8:50 a.m. to 9:00 a.m. to take action on the slate of candidates for the 2016 Board vacancies. From 9:15 a.m. to 9:45 a.m. the Board will receive committee reports and take action on the New Trial Urban Districts for 2017 and on the TEL Release Plan for Grade 8. Thereafter, from 9:45 a.m. to 10:45 a.m. the Board will receive an update and discuss the Governing Board's Strategic Planning Initiative.
The Board will meet in closed session on March 5, 2016 from 11:00 a.m. to 12:00 p.m. to receive a briefing and discuss the 2015 NAEP Reading and Mathematics Report Cards for Grade 12. This meeting must be conducted in closed session because results of this assessment have not been released to the public. Public disclosure of test results would significantly impede implementation of the NAEP assessment program if conducted in open session. Such matters are protected by exemption 9(B) of section 552b of title 5 U.S.C.
The March 5, 2016 meeting is scheduled to adjourn at 12:00 p.m.
Access to Records of the Meeting: Pursuant to FACA requirements, the public may also inspect the meeting materials at
Reasonable Accommodations: The meeting site is accessible to individuals with disabilities. If you will need an auxiliary aid or service to participate in the meeting (
Electronic Access to this Document: The official version of this document is the document published in the
You may also access documents of the Department published in the
Pub. L. 107-279, Title III—National Assessment of Educational Progress section 301.
Office of Special Education and Rehabilitative Services (OSERS), Department of Education (ED).
Notice.
In accordance with the Paperwork Reduction Act of 1995 (44 U.S.C. chapter 3501
Interested persons are invited to submit comments on or before March 21, 2016.
To access and review all the documents related to the information collection listed in this notice, please use
For specific questions related to collection activities, please contact Jim Doyle, (202) 245-6630.
The Department of Education (ED), in accordance with the Paperwork Reduction Act of 1995 (PRA) (44 U.S.C. 3506(c)(2)(A)), provides the general public and Federal agencies with an opportunity to comment on proposed, revised, and continuing collections of information. This helps the Department assess the impact of its information collection requirements and minimize the public's reporting burden. It also helps the public understand the Department's information collection requirements and provide the requested data in the desired format. ED is soliciting comments on the proposed information collection request (ICR) that is described below. The Department of Education is especially interested in public comment addressing the following issues: (1) Is this collection necessary to the proper functions of the Department; (2) will this information be processed and used in a timely manner; (3) is the estimate of burden accurate; (4) how might the Department enhance the quality, utility, and clarity of the information to be collected; and (5) how might the Department minimize the burden of this collection on the respondents, including through the use of information technology. Please note that written comments received in response to this notice will be considered public records.
Office of Fossil Energy, Department of Energy.
Notice of orders.
The Office of Fossil Energy (FE) of the Department of Energy gives notice that during January 2016, it issued orders granting authority to import and export natural gas, to import and export liquefied natural gas (LNG), and to vacate authority. These orders are summarized in the attached appendix and may be found on the FE Web site at
Take notice that the Commission has received the following Natural Gas Pipeline Rate and Refund Report filings:
Accession Number: 201601275251.
Comments/Protests Due: 5 p.m. ET 2/17/16.
Accession Number: 201601285120.
Comments/Protests Due: 5 p.m. ET 2/18/16.
Accession Number: 201601285136.
Comments/Protests Due: 5 p.m. ET 2/18/16.
Docket Number: PR16-17-000.
Accession Number: 201601285248.
284.123(g) Protests Due: 5 p.m. ET 3/28/16.
Docket Number: PR16-18-000.
Accession Number: 201601285251.
284.123(g) Protests Due: 5 p.m. ET 3/28/16.
Accession Number: 201601295026.
Comments/Protests Due: 5 p.m. ET 2/19/16.
Docket Number: PR16-20-000.
Accession Number: 201601295047.
284.123(g) Protests Due: 5 p.m. ET 3/29/16.
Comments/Protests Due: 5 p.m. ET 2/19/16.
Accession Number: 201601295078.
Comments/Protests Due: 5 p.m. ET 2/19/16.
Docket Number: PR16-23-000.
Accession Number: 201601295146.
284.123(g) Protests Due: 5 p.m. ET 3/29/16.
Accession Number: 201601295185.
Comments/Protests Due: 5 p.m. ET 2/19/16.
Any person desiring to intervene or protest in any of the above proceedings must file in accordance with Rules 211 and 214 of the Commission's Regulations (18 CFR 385.211 and 385.214) on or before 5:00 p.m. Eastern time on the specified date(s). Protests may be considered, but intervention is necessary to become a party to the proceeding.
Any person desiring to protest in any of the above proceedings must file in accordance with Rule 211 of the Commission's Regulations (18 CFR 385.211) on or before 5:00 p.m. Eastern time on the specified comment date.
The filings are accessible in the Commission's eLibrary system by clicking on the links or querying the docket number.
eFiling is encouraged. More detailed information relating to filing requirements, interventions, protests, service, and qualifying facilities filings can be found at:
This is a supplemental notice in the above-referenced proceeding of Smith Creek Hydro, LLC's application for market-based rate authority, with an accompanying rate tariff, noting that such application includes a request for blanket authorization, under 18 CFR part 34, of future issuances of securities and assumptions of liability.
Any person desiring to intervene or to protest should file with the Federal Energy Regulatory Commission, 888 First Street NE., Washington, DC 20426, in accordance with Rules 211 and 214 of the Commission's Rules of Practice and Procedure (18 CFR 385.211 and 385.214). Anyone filing a motion to intervene or protest must serve a copy of that document on the Applicant.
Notice is hereby given that the deadline for filing protests with regard to the applicant's request for blanket authorization, under 18 CFR part 34, of future issuances of securities and assumptions of liability, is March 1, 2016.
The Commission encourages electronic submission of protests and interventions in lieu of paper, using the FERC Online links at
Persons unable to file electronically should submit an original and 5 copies of the intervention or protest to the Federal Energy Regulatory Commission, 888 First Street NE., Washington, DC 20426.
The filings in the above-referenced proceeding are accessible in the Commission's eLibrary system by clicking on the appropriate link in the above list. They are also available for electronic review in the Commission's Public Reference Room in Washington, DC. There is an eSubscription link on the Web site that enables subscribers to receive email notification when a document is added to a subscribed docket(s). For assistance with any FERC Online service, please email
Take notice that on February 10, 2016, Conway Corporation submitted a supplement to its November 19, 2015 application for proposed rate for Reactive Supply and Voltage Control.
Any person desiring to intervene or to protest this filing must file in accordance with Rules 211 and 214 of the Commission's Rules of Practice and Procedure (18 CFR 385.211, 385.214). Protests will be considered by the Commission in determining the appropriate action to be taken, but will not serve to make protestants parties to the proceeding. Any person wishing to become a party must file a notice of intervention or motion to intervene, as appropriate. Such notices, motions, or protests must be filed on or before the comment date. Anyone filing a motion to intervene or protest must serve a copy of that document on the Applicant and all the parties in this proceeding.
The Commission encourages electronic submission of protests and interventions in lieu of paper using the “eFiling” link at
This filing is accessible on-line at
This is a supplemental notice in the above-referenced proceeding of 62SK 8ME LLC's application for market-based rate authority, with an accompanying rate tariff, noting that such application includes a request for blanket authorization, under 18 CFR part 34, of future issuances of securities and assumptions of liability.
Any person desiring to intervene or to protest should file with the Federal Energy Regulatory Commission, 888 First Street NE., Washington, DC 20426, in accordance with Rules 211 and 214 of the Commission's Rules of Practice and Procedure (18 CFR 385.211 and 385.214). Anyone filing a motion to intervene or protest must serve a copy of that document on the Applicant.
Notice is hereby given that the deadline for filing protests with regard to the applicant's request for blanket authorization, under 18 CFR part 34, of future issuances of securities and assumptions of liability, is March 1, 2016.
The Commission encourages electronic submission of protests and interventions in lieu of paper, using the FERC Online links at
Persons unable to file electronically should submit an original and 5 copies of the intervention or protest to the Federal Energy Regulatory Commission, 888 First Street NE., Washington, DC 20426.
The filings in the above-referenced proceeding are accessible in the Commission's eLibrary system by clicking on the appropriate link in the above list. They are also available for electronic review in the Commission's Public Reference Room in Washington, DC. There is an eSubscription link on the Web site that enables subscribers to receive email notification when a document is added to a subscribed docket(s). For assistance with any FERC Online service, please email
This is a supplemental notice in the above-referenced proceeding of Axpo U.S. LLC's application for market-based rate authority, with an accompanying rate tariff, noting that such application includes a request for blanket authorization, under 18 CFR part 34, of future issuances of securities and assumptions of liability.
Any person desiring to intervene or to protest should file with the Federal Energy Regulatory Commission, 888 First Street, NE., Washington, DC 20426, in accordance with Rules 211 and 214 of the Commission's Rules of Practice and Procedure (18 CFR 385.211 and 385.214). Anyone filing a motion to intervene or protest must serve a copy of that document on the Applicant.
Notice is hereby given that the deadline for filing protests with regard to the applicant's request for blanket authorization, under 18 CFR part 34, of future issuances of securities and assumptions of liability, is March 1, 2016.
The Commission encourages electronic submission of protests and interventions in lieu of paper, using the FERC Online links at
Persons unable to file electronically should submit an original and 5 copies of the intervention or protest to the Federal Energy Regulatory Commission, 888 First Street NE., Washington, DC 20426.
The filings in the above-referenced proceeding are accessible in the
Take notice that the following hydroelectric application has been filed with the Commission and is available for public inspection:
a.
b.
c.
d.
e.
f.
g.
h.
i.
j.
The Commission strongly encourages electronic filing. Please file motions to intervene, protests, comments, or recommendations using the Commission's eFiling system at
The Commission's Rules of Practice and Procedure require all intervenors filing documents with the Commission to serve a copy of that document on each person whose name appears on the official service list for the project. Further, if an intervenor files comments or documents with the Commission relating to the merits of an issue that may affect the responsibilities of a particular resource agency, they must also serve a copy of the document on that resource agency.
k.
l.
m. Individuals desiring to be included on the Commission's mailing list should so indicate by writing to the Secretary of the Commission.
n.
o.
The Federal Energy Regulatory Commission (Commission) hereby gives notice that members of the Commission's staff will attend the following meeting related to the Midcontinent Independent System Operator, Inc. (MISO)—PJM Interconnection, L.L.C. (PJM) Joint and Common Market Initiative (Docket No. AD14-3-000):
The above-referenced meeting will be held at: PJM Conference & Training Center, 2750 Monroe Boulevard, Audubon, PA 19403.
The above-referenced meeting is open to the public.
Further information may be found at
The discussions at the meeting described above may address matters at issue in the following proceedings:
For more information, contact John Taber, Office of Energy Policy and Innovation, Federal Energy Regulatory Commission at (202) 502-8394 or
Take notice that the Commission has received the following Natural Gas Pipeline Rate and Refund Report filings:
Any person desiring to intervene or protest in any of the above proceedings must file in accordance with Rules 211 and 214 of the Commission's Regulations (18 CFR 385.211 and 385.214) on or before 5:00 p.m. Eastern time on the specified comment date. Protests may be considered, but intervention is necessary to become a party to the proceeding.
Any person desiring to protest in any of the above proceedings must file in accordance with Rule 211 of the Commission's Regulations (18 CFR 385.211) on or before 5:00 p.m. Eastern time on the specified comment date.
The filings are accessible in the Commission's eLibrary system by clicking on the links or querying the docket number.
eFiling is encouraged. More detailed information relating to filing requirements, interventions, protests, service, and qualifying facilities filings can be found at:
On July 8, 2015, Transcontinental Gas Pipe Line Company, LLC (Transco) filed an application in Docket No. CP15-527-000 requesting a Certificate of Public Convenience and Necessity pursuant to Section 7(c) of the Natural Gas Act to construct and operate certain natural gas pipeline facilities. The proposed project is known as the New York Bay Expansion Project (Project), and would modify existing facilities and replace existing pipeline to provide an additional 115,000 dekatherms per day of firm transportation service to National Grid New York to meet 2017-2018 winter heating season needs.
On July 21, 2015, the Federal Energy Regulatory Commission (Commission or FERC) issued its Notice of Application for the Project. Among other things, that notice alerted agencies issuing federal authorizations of the requirement to complete all necessary reviews and to reach a final decision on a request for a federal authorization within 90 days of the date of issuance of the Commission staff's Environmental Assessment (EA) for the Project. This instant notice identifies the FERC staff's planned schedule for the completion of the EA for the Project.
If a schedule change becomes necessary, additional notice will be provided so that the relevant agencies are kept informed of the Project's progress.
The Project would involve the following activities at existing aboveground facilities in the specified towns and municipalities:
• Uprate Compressor Station 200 from 30,860 horsepower (hp) to 33,000 hp (East Whiteland Township, Chester, Pennsylvania);
• uprate a unit of Compressor Station 303 from 25,000 hp to 27,500 hp (Roseland Borough, Essex, New Jersey);
• add 11,000 hp of electric-driven compression to Compressor Station 207 (Old Bridge Township, Middlesex, New Jersey); and
• install various appurtenances and modifications at three meter and regulation stations in East Brandywine Township (Chester, Pennsylvania), Sayreville Borough (Middlesex, New Jersey), and Staten Island Borough (Richmond, New York).
In addition, Transco proposes to replace three segments of its 42-inch-diameter Lower New York Bay Lateral pipeline, totaling 0.25 mile, and uprate the lateral pipeline's operating pressure from 960 to 1000 pounds per square inch in Middlesex County, New Jersey.
On October 8, 2015, the Commission issued a
In order to receive notification of the issuance of the EA and to keep track of all formal issuances and submittals in specific dockets, the Commission offers a free service called eSubscription. This can reduce the amount of time you spend researching proceedings by automatically providing you with notification of these filings, document summaries, and direct links to the documents. Go to
Additional information about the Project is available from the Commission's Office of External Affairs at (866) 208-FERC or on the FERC Web site (
This is a supplemental notice in the above-referenced proceeding of Voyager Wind I, LLC's application for market-based rate authority, with an accompanying rate tariff, noting that such application includes a request for blanket authorization, under 18 CFR part 34, of future issuances of securities and assumptions of liability.
Any person desiring to intervene or to protest should file with the Federal Energy Regulatory Commission, 888 First Street NE., Washington, DC 20426, in accordance with Rules 211 and 214 of the Commission's Rules of Practice and Procedure (18 CFR 385.211 and 385.214). Anyone filing a motion to intervene or protest must serve a copy of that document on the Applicant.
Notice is hereby given that the deadline for filing protests with regard to the applicant's request for blanket authorization, under 18 CFR part 34, of future issuances of securities and assumptions of liability, is March 1, 2016.
The Commission encourages electronic submission of protests and interventions in lieu of paper, using the FERC Online links at
Persons unable to file electronically should submit an original and 5 copies of the intervention or protest to the Federal Energy Regulatory Commission, 888 First Street NE., Washington, DC 20426.
The filings in the above-referenced proceeding are accessible in the Commission's eLibrary system by clicking on the appropriate link in the above list. They are also available for electronic review in the Commission's Public Reference Room in Washington, DC. There is an eSubscription link on the Web site that enables subscribers to receive email notification when a document is added to a subscribed docket(s). For assistance with any FERC Online service, please email
This is a supplemental notice in the above-referenced proceeding of Summer Solar LLC's application for market-based rate authority, with an accompanying rate tariff, noting that such application includes a request for blanket authorization, under 18 CFR part 34, of future issuances of securities and assumptions of liability.
Any person desiring to intervene or to protest should file with the Federal Energy Regulatory Commission, 888 First Street NE., Washington, DC 20426, in accordance with Rules 211 and 214 of the Commission's Rules of Practice and Procedure (18 CFR 385.211 and 385.214). Anyone filing a motion to intervene or protest must serve a copy of that document on the Applicant.
Notice is hereby given that the deadline for filing protests with regard to the applicant's request for blanket authorization, under 18 CFR part 34, of future issuances of securities and assumptions of liability, is March 1, 2016.
The Commission encourages electronic submission of protests and interventions in lieu of paper, using the FERC Online links at
Persons unable to file electronically should submit an original and 5 copies of the intervention or protest to the Federal Energy Regulatory Commission, 888 First Street NE., Washington, DC 20426.
The filings in the above-referenced proceeding are accessible in the Commission's eLibrary system by clicking on the appropriate link in the above list. They are also available for electronic review in the Commission's Public Reference Room in Washington, DC. There is an eSubscription link on the Web site that enables subscribers to receive email notification when a document is added to a subscribed docket(s). For assistance with any FERC Online service, please email
Take notice that on February 10, 2016, the City of West Memphis, Arkansas submitted a supplement to its November 19, 2015 application for proposed rate for Reactive Supply and Voltage Control.
Any person desiring to intervene or to protest this filing must file in accordance with Rules 211 and 214 of the Commission's Rules of Practice and Procedure (18 CFR 385.211, 385.214). Protests will be considered by the Commission in determining the appropriate action to be taken, but will not serve to make protestants parties to the proceeding. Any person wishing to become a party must file a notice of intervention or motion to intervene, as appropriate. Such notices, motions, or protests must be filed on or before the comment date. Anyone filing a motion to intervene or protest must serve a copy of that document on the Applicant and all the parties in this proceeding.
The Commission encourages electronic submission of protests and interventions in lieu of paper using the “eFiling” link at
This filing is accessible on-line at
Comment Date: 5:00 p.m. Eastern Time on February 17, 2016.
On November 21, 2014, Eastern Shore Natural Gas Company (Eastern Shore) filed an application in Docket No. CP15-18-000 requesting a Certificate of Public Convenience and Necessity pursuant to Section 7(c) of the Natural Gas Act to construct and operate certain natural gas pipeline facilities as part of the White Oak Mainline Expansion Project (White Oak Project) in Chester County, Pennsylvania, and New Castle County, Delaware. On November 18, 2015, Eastern Shore filed an amendment to its application in Docket No. CP15-18-001 to construct the Kemblesville Loop Alternative 2 along Eastern Shore's existing right-of-way. Also, on May 22, 2015, Eastern Shore filed an application in Docket No. CP15-498-000 requesting a Certificate of Public Convenience and Necessity pursuant to Section 7(c) of the Natural Gas Act to construct and operate certain natural gas pipeline facilities as part of the System Reliability Project in Kent, New Castle, and Sussex Counties, Delaware.
On December 8, 2014 and June 8, 2015, the Federal Energy Regulatory Commission (Commission or FERC) issued its respective
If a schedule change becomes necessary, additional notice will be provided so that the relevant agencies are kept informed of the projects' progress.
The White Oak Project consists of 3.3 miles of 16-inch-diameter looping pipeline (the Daleville Loop) and 2.1 miles of 16-inch-diameter looping pipeline (Kemblesville Loop) in Chester County, Pennsylvania, and 3,550 horsepower of additional compression at Eastern Shore's existing Delaware City Compressor Station in New Castle County, Delaware. The White Oak Project would result in incremental expansion capacity sufficient to support Eastern Shore's agreement to provide 45,000 dekatherms per day of firm transportation service to Calpine Energy Services, L.P.'s Garrison Energy Center.
The System Reliability Project consists of 2.5 miles of 16-inch-diameter looping pipeline in New Castle County; about 7.6 miles of 16-inch-diameter looping pipeline in Kent County; installation of various appurtenant underground and aboveground facilities; and an additional 1,775 horsepower of compression at Eastern Shore's existing Bridgeville Compressor Station in Sussex County, all in Delaware. According to Eastern Shore, the System Reliability Project would increase the reliability of natural gas to Eastern Shore's existing customers during high demand winter months.
On January 22, 2015, the Commission issued a
In order to receive notification of the issuance of the EA and to keep track of all formal issuances and submittals in specific dockets, the Commission offers a free service called eSubscription. This can reduce the amount of time you spend researching proceedings by automatically providing you with notification of these filings, document summaries, and direct links to the documents. Go to
Additional information about the Project is available from the Commission's Office of External Affairs at (866) 208-FERC or on the FERC Web site (
Additional information about the White Oak and System Reliability Projects can be obtained by contacting the environmental project manager, Gertrude Johnson, by telephone at (202) 502-6692 or by electronic mail at
Take notice that the Commission received the following electric rate filings:
The filings are accessible in the Commission's eLibrary system by clicking on the links or querying the docket number.
Any person desiring to intervene or protest in any of the above proceedings must file in accordance with Rules 211 and 214 of the Commission's Regulations (18 CFR 385.211 and 385.214) on or before 5:00 p.m. Eastern time on the specified comment date. Protests may be considered, but intervention is necessary to become a party to the proceeding.
eFiling is encouraged. More detailed information relating to filing requirements, interventions, protests, service, and qualifying facilities filings can be found at:
Take notice that the following hydroelectric application has been filed with the Commission and is available for public inspection.
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The Commission strongly encourages electronic filing. Please file comments, recommendations, terms and conditions, and prescriptions using the
The Commission's Rules of Practice require all intervenors filing documents with the Commission to serve a copy of that document on each person on the official service list for the project. Further, if an intervenor files comments or documents with the Commission relating to the merits of an issue that may affect the responsibilities of a particular resource agency, they must also serve a copy of the document on that resource agency.
k. This application has been accepted and is now ready for environmental analysis.
l. The Clark Canyon Dam Hydroelectric Project would utilize the U.S. Bureau of Reclamation's Clark Canyon Dam and outlet works including an intake structure and concrete conduit in the reservoir. The project would consist of the following new facilities: (1) A 360-foot-long, 8-foot-diameter steel penstock within the existing concrete conduit, ending in a trifurcation; (2) two 35-foot-long, 8-foot-diameter penstocks extending from the trifurcation to the powerhouse, transitioning to 6-foot-diameter before entering the powerhouse; (3) a 10-foot-long, 8-foot-diameter steel penstock leaving the trifurcation and ending in a 7-foot-diameter cone valve and reducer to control discharge into the existing outlet stilling basin; (4) a 65-foot-long, 46-foot-wide reinforced concrete powerhouse containing two vertical Francis-type turbine/generator units with a total capacity of 4.7 megawatts; (5) two 25-foot-long steel draft tubes transitioning to concrete draft tube/tailrace section; (6) a 17-foot-long, 15-foot-diameter tailrace channel connecting with the existing spillway stilling basin; (7) a 45-foot-long, 10-foot-wide aeration basin downstream of the powerhouse with three frames containing 330 diffusers; (8) a 1,100-foot-long, 4.16-kilovolt (kV) buried transmission line from the powerhouse to a substation; (9) a substation containing step-up transformers and switchgear; (10) a 7.9-mile-long, 69-kV transmission line extending from the project substation to the Peterson Flat substation (the point of interconnection); and (11) appurtenant facilities. The estimated annual generation of the Clark Canyon Dam Project would be 15.4 gigawatt-hours. All project facilities would be located on federal lands owned by the U.S. Bureau of Reclamation and the U.S. Bureau of Land Management. The applicant proposes to operate the project as run-of-release.
m. A copy of the application is available for review at the Commission in the Public Reference Room or may be viewed on the Commission's Web site at
All filings must (1) bear in all capital letters the title “COMMENTS”, “REPLY COMMENTS”, “RECOMMENDATIONS,” “TERMS AND CONDITIONS,” or “PRESCRIPTIONS;” (2) set forth in the heading the name of the applicant and the project number of the application to which the filing responds; (3) furnish the name, address, and telephone number of the person submitting the filing; and (4) otherwise comply with the requirements of 18 CFR 385.2001 through 385.2005. All comments, recommendations, terms and conditions or prescriptions must set forth their evidentiary basis and otherwise comply with the requirements of 18 CFR 4.34(b). Agencies may obtain copies of the application directly from the applicant. Each filing must be accompanied by proof of service on all persons listed on the service list prepared by the Commission in this proceeding, in accordance with 18 CFR 4.34(b), and 385.2010.
You may also register online at
n. Public notice of the filing of the initial development application, which has already been given, established the due date for filing competing applications or notices of intent. Under the Commission's regulations, any competing development application must be filed in response to and in compliance with public notice of the initial development application. No competing applications or notices of intent may be filed in response to this notice.
o. A license applicant must file no later than 60 days following the date of issuance of this notice: (1) A copy of the water quality certification; (2) A copy of the request for certification, including proof of the date on which the certifying agency received the request; or (3) evidence of waiver of water quality certification.
This is a supplemental notice in the above-referenced proceeding of Comanche Solar PV, LLC's application for market-based rate authority, with an accompanying rate tariff, noting that such application includes a request for blanket authorization, under 18 CFR part 34, of future issuances of securities and assumptions of liability.
Any person desiring to intervene or to protest should file with the Federal Energy Regulatory Commission, 888 First Street NE., Washington, DC 20426, in accordance with Rules 211 and 214 of the Commission's Rules of Practice and Procedure (18 CFR 385.211 and 385.214). Anyone filing a motion to intervene or protest must serve a copy of that document on the Applicant.
Notice is hereby given that the deadline for filing protests with regard to the applicant's request for blanket authorization, under 18 CFR part 34, of future issuances of securities and assumptions of liability, is March 2, 2016.
The Commission encourages electronic submission of protests and interventions in lieu of paper, using the FERC Online links at
Persons unable to file electronically should submit an original and 5 copies of the intervention or protest to the Federal Energy Regulatory Commission, 888 First Street NE., Washington, DC 20426.
The filings in the above-referenced proceeding are accessible in the Commission's eLibrary system by clicking on the appropriate link in the above list. They are also available for electronic review in the Commission's Public Reference Room in Washington, DC. There is an eSubscription link on the Web site that enables subscribers to receive email notification when a document is added to a subscribed docket(s). For assistance with any FERC Online service, please email
Take notice that the Commission received the following electric corporate filings:
Take notice that the Commission received the following electric rate filings:
The filings are accessible in the Commission's eLibrary system by clicking on the links or querying the docket number.
Any person desiring to intervene or protest in any of the above proceedings must file in accordance with Rules 211 and 214 of the Commission's Regulations (18 CFR 385.211 and 385.214) on or before 5:00 p.m. Eastern time on the specified comment date. Protests may be considered, but intervention is necessary to become a party to the proceeding.
eFiling is encouraged. More detailed information relating to filing requirements, interventions, protests, service, and qualifying facilities filings can be found at:
Take notice that the Commission received the following exempt wholesale generator filings:
Take notice that the Commission received the following electric rate filings:
The filings are accessible in the Commission's eLibrary system by clicking on the links or querying the docket number.
Any person desiring to intervene or protest in any of the above proceedings must file in accordance with Rules 211 and 214 of the Commission's Regulations (18 CFR 385.211 and 385.214) on or before 5:00 p.m. Eastern time on the specified comment date. Protests may be considered, but intervention is necessary to become a party to the proceeding.
eFiling is encouraged. More detailed information relating to filing requirements, interventions, protests, service, and qualifying facilities filings can be found at:
On June 8, 2015, Columbia Gas Transmission, LLC (Columbia Gas) filed an application in Docket No. CP15-514-000 requesting a Certificate of Public Convenience and Necessity pursuant to Section 7(c) and 7(b) of the Natural Gas Act to construct, operate, abandon in-place, and maintain certain natural gas pipeline facilities. The proposed Leach XPress Project, located in West Virginia, Ohio, and Pennsylvania, would provide about 1.5 million dekatherms of natural gas per day of firm transportation service to natural gas consumers served by the Columbia Gas pipeline systems.
Additionally, on July 29, 2015, Columbia Gulf Transmission, LLC (Columbia Gulf) filed an application in Docket No. CP15-539-000 requesting a Certificate of Public Convenience and Necessity pursuant to Section 7(c) of the Natural Gas Act to construct, own, and operate the proposed Rayne XPress Expansion Project. The Rayne Express Expansion Project, located in Kentucky, would add new compression and provide about 621,000 dekatherms per day of firm transportation on Columbia Gulf's system. Together, these proposals are referred to in this notice as “the Projects.”
On June 22 and August 11, 2015, respectively, the Federal Energy Regulatory Commission (FERC or Commission) issued its Notice of Application for the Leach XPress Project and Rayne XPress Expansion Project. Among other things, these notices alerted other agencies issuing federal authorizations of the requirement to complete all necessary reviews and to reach a final decision on the request for a federal authorization within 90 days of the date of issuance of the Commission staff's final Environmental Impact Statement (EIS) for the Projects. This instant notice identifies the FERC staff's planned schedule for completion of the final EIS for the Projects.
If a schedule change becomes necessary, an additional notice will be provided so that the relevant agencies are kept informed of the Project's progress.
Columbia Gas plans to construct approximately 160 miles of new natural gas pipeline in West Virginia (Marshall County), Ohio (Fairfield, Hocking, Monroe, Morgan, Muskingum, Noble, Perry and Vinton Counties) and Pennsylvania (Greene County), two new compressor stations in Ohio (Noble and Jackson Counties), one new compressor station in West Virginia (Marshall County), and modify two existing compressor stations in West Virginia and Ohio.
Columbia Gulf plans to construct and operate 51,800 horsepower of new compression in two new compressor stations located in Carter, Menifee and Montgomery Counties, Kentucky, and modify the existing Means Measurement and Regulation Station in Means and Montgomery County, Kentucky.
On October 9, 2014, the Commission staff granted Columbia Gas's request to use the FERC's Pre-filing environmental review process and assigned the Leach XPress Project Docket No. PF14-23-000. On January 13, 2015, the Commission issued a
Both NOIs were sent to federal, state, and local government agencies; elected officials; affected landowners; environmental and public interest groups; Native American tribes and regional organizations; commentors and other interested parties; and local libraries and newspapers. The primary issues raised by the commentors included federally listed bats, forested plant and animal habitat, freshwater mussel habitat, salamander habitat, potential future subsidence of mining land, and effects on public health and safety.
The U.S. Environmental Protection Agency, U.S. Army Corps of Engineers, U.S. Fish and Wildlife Service, Ohio Environmental Protection Agency, the West Virginia Department of Environmental Protection, the West Virginia Department of Natural Resources, and the Kentucky Department for Environmental Protection are cooperating agencies in the preparation of the EIS.
In order to receive notification of the issuance of the EIS and to keep track of all formal issuances and submittals in specific dockets, the Commission offers a free service called eSubscription. This can reduce the amount of time you spend researching proceedings by automatically providing you with notification of these filings, document summaries, and direct links to the documents. Go to
Additional information about the Projects is available from the Commission's Office of External Affairs at (866) 208-FERC or on the FERC Web site (
Western Area Power Administration, DOE.
Notice of transfer of functional control of eligible Western-Upper Great Plains Region transmission facilities to Southwest Power Pool, Inc. on October 1, 2015, and Rate Schedules WAUGP-ATRR, WAUGP-AS1, WAUW-AS3, WAUW-AS4, WAUW-AS5, WAUW-AS6 and WAUW-AS7 made effective on that date.
Western Area Power Administration (Western) transferred functional control of eligible Western-Upper Great Plains Region (Western-UGP) transmission facilities to Southwest Power Pool, Inc. (SPP) on October 1, 2015. Transmission service is being provided over Western-UGP's eligible facilities under SPP's Open Access Transmission Tariff. Western-UGP costs are included in Western-UGP Formula rates for Transmission and Ancillary Services under Rate Schedules WAUGP-ATRR, WAUGP-AS1, WAUW-AS3, WAUW-AS4, WAUW-AS5, WAUW-AS6 and WAUW-AS7, which became effective on October 1, 2015.
Mr. Lloyd Linke, Vice President of Operations for Upper Great Plains Region, Upper Great Plains Region, Western Area Power Administration, 1330 41st Street, Watertown, SD, 57201; telephone: (605) 882-7500; email:
On July 27, 2015, Western published a
The purpose of this notice is to announce that Western-UGP successfully transferred functional control of eligible transmission facilities on October 1, 2015, and Rate Schedules WAUGP-ATRR, WAUGP-AS1, WAUW-AS3, WAUW-AS4, WAUW-AS5, WAUW-AS6 and WAUW-AS7 were made effective on that date.
Information regarding the public process for Western-UGP's formula rate adjustment process and annual recalculation is available on Western's Web site and Western-UGP's Open Access Same-Time Information System (OASIS) home page, which are located respectively at the following locations:
Environmental Protection Agency (EPA).
Request for Nominations to the National Environmental Justice Advisory Council (NEJAC).
The U.S. Environmental Protection Agency (EPA) invites nominations from a diverse range of qualified candidates to be considered for appointment to its National Environmental Justice Advisory Council (NEJAC). The NEJAC was chartered to provide advice regarding broad, cross-cutting issues related to environmental justice. This notice solicits nominations to fill approximately six (6) new vacancies for terms through September 2019. To maintain the representation outlined by the charter, nominees will be selected to represent: grassroots community-based organizations (2 vacancies); non-governmental/environmental organizations (2 vacancies); State government agencies (1 vacancy); and business and industry (1 vacancy). Vacancies are anticipated to be filled by July 2016. Sources in addition to this
Nominations should be submitted in time to arrive no later than Friday, April 15, 2016.
Submit nominations electronically with the subject line NEJAC Membership 2016 to
Matthew Tejada, Designated Federal Officer for the NEJAC, U.S. EPA; telephone (202) 564-8047; fax: (202) 564-1624.
The NEJAC is a federal advisory committee chartered under the Federal Advisory Committee Act (FACA), Public Law 92-463. EPA established the NEJAC in 1993 to provide independent consensus advice to the EPA Administrator about a broad range of environmental issues related to environmental justice. The NEJAC conducts business in accordance with the Federal Advisory Committee Act (FACA) (5 U.S.C. App. 2) and related regulations.
The Council consists of 28 members (including a Chairperson) appointed by EPA's Administrator. Members serve as non-federal stakeholders representing: six (6) from academia, two (2) from business and industry; six (6) from community based organizations; seven (7) from non-governmental/environmental organizations; four (4) from state and local governments; and three (3) from tribal governments and indigenous organizations, of which one member serves as a liaison to the National Tribal Caucus. Members are appointed for three (3)-year terms with
The NEJAC usually meets face-to-face twice a year, generally in the Spring and the Fall. Additionally, members may be asked to participate in teleconference meetings or serve on work groups to develop recommendations, advice letters, and reports to address specific policy issues. The average workload for members is approximately 5 to 8 hours per month. EPA provides reimbursement for travel and other incidental expenses associated with official government business.
Other criteria used to evaluate nominees will include:
• The background and experience that would help members contribute to the diversity of perspectives on the committee (
• demonstrated experience with environmental justice and community sustainability issues at the national, state, or local level;
• excellent interpersonal and consensus-building skills;
• ability to volunteer time to attend meetings 2-3 times a year, participate in teleconference meetings, attend listening sessions with the Administrator or other senior-level officials, develop policy recommendations to the Administrator, and prepare reports and advice letters; and
• willingness to commit time to the committee and demonstrated ability to work constructively and effectively on committees.
• Current contact information for the nominee, including the nominee's name, organization (and position within that organization), current business address, email address, and daytime telephone number.
• Brief Statement describing the nominees interest in serving on the NEJAC
• Résumé and a short biography (no more than 2 paragraphs) describing the professional and educational qualifications of the nominee, including a list of relevant activities, and any current or previous service on advisory committees
• Letter[s] of recommendation from a third party supporting the nomination. Letter[s] should describe how the nominee's experience and knowledge will bring value to the work of the NEJAC.
Other sources, in addition to this
The Federal Communications Commission will hold an Open Meeting on the subjects listed below on Thursday, February 18, 2016, which is scheduled to commence at 10:30 a.m. in Room TW-C305, at 445 12th Street SW., Washington, DC.
The Federal Communications Commission will hold an Open Meeting on the subjects listed below on Thursday, February 18, 2016, which is scheduled to commence at 10:30 a.m. in Room TW-C305, at 445 12th Street SW., Washington, DC.
The Commission will consider the following subjects listed below as a consent agenda and these items will not be presented individually:
The meeting site is fully accessible to people using wheelchairs or other mobility aids. Sign language interpreters, open captioning, and assistive listening devices will be provided on site. Other reasonable accommodations for people with disabilities are available upon request. In your request, include a description of the accommodation you will need and a way we can contact you if we need more information. Last minute requests will be accepted, but may be impossible to fill. Send an email to:
Additional information concerning this meeting may be obtained from the Office of Media Relations, (202) 418-0500; TTY 1-888-835-5322. Audio/Video coverage of the meeting will be broadcast live with open captioning over the Internet from the FCC Live Web page at
For a fee this meeting can be viewed live over George Mason University's Capitol Connection. The Capitol Connection also will carry the meeting live via the Internet. To purchase these services, call (703) 993-3100 or go to
Federal Communications Commission.
Notice and request for comments.
As part of its continuing effort to reduce paperwork burdens, and as required by the Paperwork Reduction Act (PRA) of 1995 (44 U.S.C. 3501-3520), the Federal Communications Commission (FCC or Commission) invites the general public and other Federal agencies to take this opportunity to comment on the following information collections. Comments are requested concerning: whether the proposed collection of information is necessary for the proper performance of the functions of the Commission, including whether the information shall have practical utility; the accuracy of the Commission's burden estimate; ways to enhance the quality, utility, and clarity of the information collected; ways to minimize the burden of the collection of information on the respondents, including the use of automated collection techniques or other forms of information technology; and ways to further reduce the information collection burden on small business concerns with fewer than 25 employees. The FCC may not conduct or sponsor a collection of information unless it displays a currently valid OMB control number. No person shall be subject to any penalty for failing to comply with a collection of information subject to the PRA that does not display a valid OMB control number.
Written PRA comments should be submitted on or before April 18, 2016. If you anticipate that you will be submitting comments, but find it difficult to do so within the period of time allowed by this notice, you should advise the contact listed below as soon as possible.
Direct all PRA comments to Cathy Williams, FCC, via email
For additional information about the information collection, contact Cathy Williams at (202) 418-2918.
Federal Communications Commission.
Notice and request for comments.
As part of its continuing effort to reduce paperwork burdens, and as required by the Paperwork Reduction Act (PRA) of 1995 (44 U.S.C. 3501-3520), the Federal Communications Commission (FCC or the Commission) invites the general public and other Federal agencies to take this opportunity to comment on the following information collection.
Written PRA comments should be submitted on or before April 18, 2016. If you anticipate that you will be submitting comments, but find it difficult to do so within the period of time allowed by this notice, you should advise the contact listed below as soon as possible.
Direct all PRA comments to Nicole Ongele, FCC, via email
For additional information about the information collection, contact Nicole Ongele at (202) 418-2991.
Federal Election Commission.
Tuesday, February 23, 2016 at 10:00 a.m. and its continuation at the conclusion of the open meeting on February 25, 2016.
999 E Street NW., Washington, DC.
This meeting will be closed to the public.
Compliance matters pursuant to 52 U.S.C. 30109.
Matters concerning participation in civil actions or proceeding, or arbitration.
Information the premature disclosure of which would be likely to have a considerable adverse effect on the implementation of a proposed Commission action.
Judith Ingram, Press Officer, Telephone: (202) 694-1220.
The Commission hereby gives notice of the filing of the following agreements under the Shipping Act of 1984. Interested parties may submit comments on the agreement to the Secretary, Federal Maritime Commission, Washington, DC 20573, within twelve days of the date this notice appears in the
By Order of the Federal Maritime Commission.
Agency for Toxic Substances and Disease Registry (ATSDR), Department of Health and Human Services (HHS).
Notice with comment period.
Agency for Toxic Substances and Disease Registry (ATSDR), as part of its continuing efforts to reduce public burden and maximize the utility of government information, invites the general public and other Federal agencies to take this opportunity to comment on proposed and/or continuing information collections, as required by the Paperwork Reduction Act of 1995. This notice invites comment on “Collections Related to Synthetic Turf Fields with Crumb Rubber Infill.” The purpose of the proposed studies is to evaluate and characterize the chemical composition and use of synthetic turf with crumb rubber infill and exposure potential to constituents in crumb rubber infill.
Written comments must be received on or before April 18, 2016.
You may submit comments, identified by Docket No. ATSDR-2016-0002 by any of the following methods:
•
•
All public comment should be submitted through the Federal eRulemaking portal (Regulations.gov) or by U.S. mail to the address listed above.
To request more information on the proposed project or to obtain a copy of the information collection plan and instruments, contact the Information Collection Review Office, Centers for Disease Control and Prevention, 1600 Clifton Road NE., MS-D74, Atlanta, Georgia 30329; phone: 404-639-7570; Email:
Under the Paperwork Reduction Act of 1995 (PRA) (44 U.S.C. 3501-3520), Federal agencies must obtain approval from the Office of Management and Budget (OMB) for each collection of information they conduct or sponsor. In addition, the PRA also requires Federal agencies to provide a 60-day notice in the
Comments are invited on: (a) Whether the proposed collection of information is necessary for the proper performance of the functions of the agency, including whether the information shall have practical utility; (b) the accuracy of the agency's estimate of the burden of the proposed collection of information; (c) ways to enhance the quality, utility, and clarity of the information to be collected; (d) ways to minimize the burden of the collection of information on respondents, including through the use of automated collection techniques or other forms of information technology; and (e) estimates of capital or start-up costs and costs of operation, maintenance, and purchase of services to provide information. Burden means the total time, effort, or financial resources expended by persons to generate, maintain, retain, disclose or provide information to or for a Federal agency. This includes the time needed to review instructions; to develop, acquire, install and utilize technology and systems for the purpose of collecting, validating and verifying information, processing and maintaining information, and disclosing and providing information; to train personnel and to be able to respond to a collection of information, to search data sources, to complete and review the collection of information; and to transmit or otherwise disclose the information.
Collections Related to Synthetic Turf Fields with Crumb Rubber Infill—New—Agency for Toxic Substances and Disease Registry (ATSDR).
Currently in the United States, there are more than 12,000 synthetic turf fields in use. While the Synthetic Turf Council has set guidelines for the content of crumb rubber used as infill in synthetic turf fields, manufacturing processes result in differences among types of crumb rubber. Additionally, the chemical composition may vary highly between different processes and source materials and may vary even within granules from the same origin.
Due to the limited information, the Agency for Toxic Substances and Disease Registry (ATSDR) and the United States Environmental Protection Agency (USEPA) propose to conduct two studies to investigate the chemical composition and use of crumb rubber infill in synthetic turf and the potential for exposure to environmental constituents that may result from contact with crumb rubber infill.
Prior to study initiation, outreach and engagement efforts may be undertaken among stakeholders, including but not limited to industry representatives, state or local partners, and sports coaches. These efforts will inform the design and implementation of the proposed studies and will involve less than ten respondents per stakeholder groups. The outreach and engagement efforts will allow us to better understand the manufacturing process for synthetic turf and crumb rubber infill and allow us to obtain first-hand perspectives on activities conducted on synthetic turf leading to potential exposures. Additionally, outreach efforts will involve discussions and coordination with state partners to identify their current and future research studies on synthetic turf.
The first study, titled “Determination of Field Operating Procedures, Use Conditions, and Chemical Composition of Crumb Rubber Infill in Synthetic Turf
The second study, titled “Characterization of Exposure Potential during Activities Conducted on Synthetic Turf with Crumb Rubber Infill,” will be the first assessment of activities conducted on synthetic turf for the purpose of characterizing potential exposure patterns. The study will include persons who use synthetic turf with crumb rubber infill (
Furthermore, if time and resources allow, we will conduct a full exposure characterization sub-study among a subset of the respondents. If possible, we will use the facilities sampled in the first study to conduct activities for the full exposure characterization of facility users. The exposure characterization sub-study will likely include but is not limited to field environment and material sampling, personal air monitoring, dermal sampling, and urine collection. It is likely that some of the collection items will not be analyzed in the current project time frame but will be archived for future analysis.
The burden hours for the research study of crumb rubber infill composition and field operating procedures is 76 hours among 40 respondents; the burden hours requested for the research study of activity levels in persons playing on synthetic turf with crumb rubber infill is 216 hours among 60 respondents. The total estimated annual time burden requested for these studies equals 292 hours. There is no cost to the respondents other than their time in the study.
“Determination of Field Operating Procedures, Use Conditions, and Chemical Composition of Crumb Rubber Infill in Synthetic Turf Fields”
The Centers for Disease Control and Prevention (CDC) has submitted the following information collection request to the Office of Management and Budget (OMB) for review and approval in accordance with the Paperwork Reduction Act of 1995. The notice for the proposed information collection is published to obtain comments from the public and affected agencies.
Written comments and suggestions from the public and affected agencies concerning the proposed collection of information are encouraged. Your comments should address any of the following: (a) Evaluate whether the proposed collection of information is necessary for the proper performance of the functions of the agency, including whether the information will have practical utility; (b) Evaluate the accuracy of the agencies estimate of the burden of the proposed collection of information, including the validity of the methodology and assumptions used; (c) Enhance the quality, utility, and clarity of the information to be collected; (d) Minimize the burden of the collection of information on those who are to respond, including through the use of appropriate automated, electronic, mechanical, or other technological collection techniques or other forms of information technology,
To request additional information on the proposed project or to obtain a copy of the information collection plan and instruments, call (404) 639-7570 or send an email to
Integrating Community Pharmacists and Clinical Sites for Patient-Centered HIV Care (OMB 0920-1019, expires 8/31/2018)—Revision—National Center for HIV/AIDS, Viral Hepatitis, STD, and TB Prevention (NCHHSTP), Centers for Disease Control and Prevention (CDC).
Medication Therapy Management (MTM) is a group of pharmacist provided services that is independent of, but can occur in conjunction with, provision of medication. Medication Therapy Management encompasses a broad range of professional activities and cognitive services within the licensed pharmacists' scope of practice and can include monitoring prescription filling patterns and timing of refills, checking for medication interactions, patient education, and monitoring of patient response to drug therapy.
HIV specific MTM programs have demonstrated success in improving HIV medication therapy adherence and persistence. While MTM programs have be shown to be effective in increasing medication adherence for HIV-infected persons, no MTM programs have been expanded to incorporate primary medical providers in an effort to establish patient-centered HIV care. To address this problem, CDC has entered into a public-private partnership with Walgreen Company (a.k.a. Walgreens pharmacies, a national retail pharmacy chain) to develop and implement a model of HIV care that integrates community pharmacists with primary medical providers for patient-centered HIV care. The model program will be implemented in ten sites and will provide patient-centered HIV care for approximately 1,000 persons.
The patient-centered HIV care model will include the core elements of MTM as well as additional services such as individualized medication adherence counseling, active monitoring of prescription refills and active collaboration between pharmacists and medical clinic providers to identify and resolve medication related treatment problems such as treatment effectiveness, adverse events and poor adherence. The expected outcomes of the model program are increased retention in HIV care, adherence to HIV medication therapy and viral load suppression.
On May 16, 2014 OMB approved the collection of standardized information from ten project sites over the three-year project period and one retrospective data collection during the first year of the three-year project period. The retrospective data collection will provide information about clients' baseline characteristics prior to participation in the model program which is needed to compare outcomes before and after program implementation. On August 17, 2015, OMB approved the conduct of key informant interviews with program clinic and pharmacy staff in order to evaluate the program processes, administration of a staff communication questionnaire, and OMB approved the collection of time and cost data to be used to estimate the cost of the model program.
CDC newly requests approval to administer a staff communication questionnaire for medical providers in order to determine how and if the model program improves patient outcomes through improved communication and collaboration between patients' clinical providers and pharmacists. The staff communication questionnaire for medical providers will be administered twice to program clinic staff. The staff communication questionnaire for medical providers is different from the previously improved staff communication questionnaire; the staff communication questionnaire for medical providers will be administered to program clinic staff whereas the staff communication questionnaire will be administered to program pharmacy staff.
Pharmacy, laboratory, and medical data will be collected through abstraction of all participant clients' pharmacy and medical records. Pharmacy, laboratory and medical data are needed to monitor retention in care, adherence to therapy, viral load suppression and other health outcomes. Program specific data, such as the number of MTM elements completed per project site and time spent on program activities, will be collected by program. Qualitative data will be gathered from program staff through in-person or telephone interviews and through a questionnaire to program pharmacy staff and a separate questionnaire to program clinic staff.
The data collection will allow CDC to conduct continuous program performance monitoring which includes identification of barriers to program implementation, solutions to those barriers, and documentation of client health outcomes. Performance monitoring will allow the model program to be adjusted, as needed, in order to develop a final implementation model that is self-sustaining and which can be used to establish similar collaborations in a variety of clinical settings. Collection of cost data will allow for the cost of the program to be estimated.
There is no cost to participants other than their time. The total estimated annualized burden hours are 6,043.
Centers for Medicare & Medicaid Services (CMS), Department of Health and Human Services (HHS).
Altered System Notice, Adding a New Routine Use for a CMS System of Records.
In accordance with the requirements of the Privacy Act of 1974 (5 U.S.C. 552a), CMS is adding a new routine use to the existing system of records titled Enrollment Data Base (EDB), System No. 09-70-0502, last modified 73
The new routine use will authorize CMS to disclose information maintained in the system “to the IRS for the purposes of reporting Medicare Part A enrollment information and to provide statements to the individual enrollees with respect to whom information is reported to the IRS. Disclosures made pursuant to the routine use will be coordinated through CMS' Division of Medicare Enrollment Coordination, Medicare Enrollment and Appeals Group, Center for Medicare.
The public should address comments to: CMS Privacy Officer, Division of Security, Privacy Policy and Governance, Information Security and Privacy Group, Office of Enterprise Information, CMS, 7500 Security Boulevard, Baltimore, MD 21244-1870, Mailstop: N 1-24-08, Office: (410) 786-5357 or via email:
Roland Herrera, Health Insurance Specialist, Division of Medicare Enrollment Coordination, Medicare Enrollment and Appeals Group, CMS Center for Medicare, 7500 Security Boulevard, Mail Stop C2-12-16, Baltimore, MD 21244, Office phone: 410.786.0668, Facsimile: 443.380.5418, Email:
CMS is required to produce reports and statements of enrollment in Medicare Part A to confirm enrollment in minimum essential coverage under Section 6055 of the Affordable Care Act. The enrollment information must be provided to the IRS for tax administration purposes to enable the IRS to properly assess tax returns filed to ensure that Medicare Part A Enrollees are not assessed a tax penalty for not beenrolled in health care coverage.
For the reason explained above, the following routine use is added to Enrollment Data Base (EDB), System No. 09-70-0502:
11. To the IRS for the purposes of reporting Medicare Part A enrollment information and to provide statements to the individual enrollees with respect to whom information is reported to the IRS.
Administration on Intellectual and Developmental Disabilities (AIDD), Administration on Disabilities (AoD), Administration for Community Living (ACL), Department of Health and Human Services (HHS), HHS.
Notice of guidance.
The Administration on Intellectual and Developmental Disabilities (AIDD) within the Administration on Disabilities (AoD), located within the Administration for Community Living (ACL) at the United States Department of Health and Human Services (HHS), is soliciting comments from the public on the New Funding Formula for the State Councils on Developmental Disabilities (SCDDs) and Protection and Advocacy Systems (P&As) located in each State and Territory.
To ensure consideration comments must be received no later than March 21, 2016.
The revised formula is described below and a table demonstrating the effects of the revised formula on allocations to States based on the FY 2016 appropriations can be found at the Web site:
Andrew Morris, Office of the Commissioner, Administration on Disabilities, 330 C St. SW., Washington, DC 20201. Telephone (202) 795-7408. Email
The Developmental Disabilities Assistance and Bill of Rights Act of 2000 (P.L. 106-402) (DD Act) provides, among other things, formula grants to States for the purpose of operating State Councils on Developmental Disabilities and Protection & Advocacy Systems for People with Developmental Disabilities. The DD Act provides authority and flexibility in Section 122 to AIDD to determine the formula for allocating annual grant awards using three statutory factors for determining each state's funding amount. These factors are:
The current formula is out of date. For example, the current formula uses the best data points available in the 1970s/1980s for determining need for services and financial need. These data are now outdated and severely undercount the population of individuals with developmental disabilities. The updated formula is believed to be more clear, concise, transparent, and consistent with Congress' intent to provide funds to states based on greatest need.
In addition to the formula, the DD Act prescribes minimum allotments for states with small populations and territories (Puerto Rico is not considered a territory under the DD Act). About half of the states receive a minimum allotment. The DD Act also requires adjusting (increasing) the minimum allotment amounts if certain criteria are met. After minimum allotments are met, the remaining appropriations are allocated using the formula.
Finally, the Act requires a hold-harmless for the State DD Councils that was passed as an amendment to the DD Act in 2003, P.L. 108-154. Through this hold-harmless clause, SCDD awards are based on the award amount from the previous year, FY 2000, FY 2001, or FY 2002, whichever is highest. If there are not enough funds available to fully fund all of the awards, the SCDDs then receive an equal percent reduction. It is important to note that a new formula may not immediately impact the SCDDs due to the hold harmless clause. The new formula would impact the SCDDs only when appropriations rise to such a level that all SCDDs would receive an increase in allotments above the previous fiscal year's award level.
AIDD convened a workgroup of researchers, retired SCDD and P&A directors, national associations, and AIDD staff in the spring of 2015 and held four meetings over a two month period. The workgroup reviewed the three elements required for the formula and discussed each, identifying potential data sources for each element in cooperation with the HHS Assistant Secretary for Policy and Evaluation (ASPE). The workgroup discussed the strengths and challenges of the different data and based on these discussions provided recommendations to AIDD. In addition, the workgroup worked with the Grants Management Office at ACL to test the impact of different scenarios.
Beginning in FY 2017, AIDD's State DD Councils and P&A grants will use a new formula to distribute funds after meeting statutory minimums and hold-harmless requirements:
1.
2.
In determining the need for services, the workgroup discussed using data sources such as Medicaid and the Individuals with Disabilities Education Act; concluding that these data are unreliable because each State determines program eligibility and reporting requirements differently. The prevalence rate for developmental disabilities of 1.58 percent was established by the Federal government in the early 1990s through the NHIS-D and is still the most current prevalence rate available that meets the definition of Developmental Disabilities per the DD Act.
3.
The workgroup thought it was best to use a combination of a State/Territory's poverty and unemployment rates because it best reflects the economic status of a State/Territory and, thus, their financial need.
This notice invites public comment on the new formula for the SCDD and P&A annual awards. We seek diverse perspectives including, but not limited to, that of grantees, technical assistance providers, and advocates, as well as federal agencies and for-profit and not-for-profit stakeholders. The comments will be important factors in finalizing the formula.
Food and Drug Administration, HHS.
Notice.
The Food and Drug Administration (FDA) is announcing that a proposed collection of information has been submitted to the Office of Management and Budget (OMB) for review and clearance under the Paperwork Reduction Act of 1995.
Fax written comments on the collection of information by March 21, 2016.
To ensure that comments on the information collection are received, OMB recommends that written comments be faxed to the Office of Information and Regulatory Affairs, OMB, Attn: FDA Desk Officer, FAX: 202-395-7285, or emailed to
FDA PRA Staff, Office of Operations, Food and Drug Administration, 8455 Colesville Rd., COLE-14526, Silver Spring, MD 20993-0002,
In compliance with 44 U.S.C. 3507, FDA has submitted the following proposed collection of information to OMB for review and clearance.
Section 409 of the Federal Food, Drug, and Cosmetic Act (FD&C Act) (21 U.S.C. 348) establishes a premarket approval requirement for “food additives”; section 201(s) of the FD&C Act (21 U.S.C. 321(s)) provides an exclusion to the definition of “food additive” and thus from the premarket approval requirement, for uses of substances that are generally recognized as safe (GRAS) by qualified experts. In the
To assist respondents in submissions to our Center for Food Safety and Applied Nutrition (CFSAN), we developed Form FDA 3667 entitled “Generally Recognized as Safe (GRAS) Notice.” The form, and elements prepared as attachments to the form, may be submitted in electronic format via the Electronic Submission Gateway (ESG), or may be submitted in paper format, or as electronic files on physical media with paper signature page. While we do not expect Form FDA 3667 to reduce reporting time for respondents, use of the form helps to expedite our review of the information being submitted. For submissions to our Center for Veterinary Medicine (CVM), respondents may continue to send GRAS notices in letter format to the Agency, as instructed in our
Presently, we have committed to issuing a final rule regarding “Substances Generally Recognized as Safe” in 2016, as part of a settlement agreement with the Center for Food Safety, which filed a lawsuit in 2014 seeking to vacate our 1997 proposed rule.
In the
We estimate the burden of this collection of information as follows:
For purposes of this extension request, we are retaining our 2012 estimates. The PRA analysis for the GRAS final rule will take into account any changes to the GRAS notification procedure as set forth in the final rule and we will revise the collection accordingly.
Food and Drug Administration, HHS.
Notice.
The Food and Drug Administration (FDA) is requesting that any industry organizations interested in participating in the selection of nonvoting industry representatives to serve on certain panels of the Medical Devices Advisory Committee (MDAC) in the Center for Devices and Radiological Health (CDRH) notify FDA in writing. FDA is also requesting nominations for nonvoting industry representatives to serve on certain device Panels of the MDAC in the CDRH. A nominee may either be self-nominated or nominated by an organization to serve as a nonvoting industry representative. Nominations will be accepted for current and upcoming vacancies effective with this notice. FDA seeks to include the views of women, and men, members of all racial and ethnic groups and individuals with and without disabilities on its advisory committees and, therefore encourages nominations of appropriately qualified candidates from these groups.
Any industry organization interested in participating in the selection of an appropriate nonvoting member to represent industry interests must send a letter stating that interest to FDA by March 21, 2016, (see sections I and II for further details). Concurrently, nomination materials for prospective candidates should be sent to FDA by March 21, 2016.
All statements of interest from industry organizations interested in participating in the selection process of nonvoting industry representative nomination should be sent to Margaret Ames (see
Margaret Ames, Center for Devices and Radiological Health, Food and Drug Administration, 10903 New Hampshire Ave., Bldg. 66, Rm. 5215, Silver Spring, MD 20993, 301-796-5960, Fax: 301-847-8505,
The Agency is requesting nominations for nonvoting industry representatives to certain panels identified in the following paragraphs:
The Committee reviews and evaluates data on the safety and effectiveness of marketed and investigational devices and makes recommendations for their regulation. The panels engage in a number of activities to fulfill the functions the Federal Food, Drug, and Cosmetic Act envisions for device advisory panels. With the exception of the Medical Devices Dispute Resolution Panel, each panel, according to its specialty area, advises the Commissioner of Food and Drugs regarding recommended classification or reclassification of devices into one of three regulatory categories; advises on any possible risks to health associated with the use of devices; advises on formulation of product development protocols; reviews premarket approval applications for medical devices; reviews guidelines and guidance documents; recommends exemption of certain devices from the application of portions of the Act; advises on the necessity to ban a device; and responds to requests from the agency to review and make recommendations on specific issues or problems concerning the safety and effectiveness of devices. With the exception of the Medical Devices Dispute Resolution Panel, each panel, according to its specialty area, may also make appropriate recommendations to the Commissioner of Food and Drugs on issues relating to the design of clinical studies regarding the safety and effectiveness of marketed and investigational devices. The Committee also provides recommendations to the Commissioner or designee on complexity categorization of in vitro diagnostics under the Clinical Laboratory Improvement Amendments of 1988.
Reviews and evaluates data concerning the safety and effectiveness of marketed and investigational devices for use in anesthesiology and respiratory therapy and makes appropriate recommendations to the Commissioner of Food and Drugs.
Reviews and evaluates data concerning the safety and effectiveness of marketed and investigational ear, nose and throat devices and makes appropriate recommendations to the Commissioner of Food and Drugs.
Reviews and evaluates data concerning the safety and effectiveness of marketed and investigational gastroenterology, urology and nephrology devices and makes appropriate recommendations to the Commissioner of Food and Drugs.
Reviews and evaluates data concerning the safety and effectiveness of marketed and investigational general and plastic surgery devices and makes appropriate recommendations to the Commissioner of Food and Drugs.
Reviews and evaluates data concerning the safety and effectiveness of marketed and investigational in vitro devices for use in clinical laboratory medicine including pathology, hematology, histopathology, cytotechnology and molecular biology and makes appropriate recommendations to the Commissioner of Food and Drugs.
Provides advice to the Center Director on complex or contested scientific issues between the FDA and medical device sponsors, applicants, or manufacturers relating to specific products, marketing applications, regulatory decisions and actions by FDA, and Agency guidance and policies. The Panel makes recommendations on issues that are lacking resolution, are highly complex in nature, or result from challenges to Agency decisions or actions.
Reviews and evaluates data concerning the safety and effectiveness of marketed and investigational in vitro devices for use in clinical laboratory medicine including microbiology, virology, and infectious disease and makes appropriate recommendations to the Commissioner of Food and Drugs.
Reviews and evaluates data concerning the safety and effectiveness of marketed and investigational in vitro devices for use in clinical laboratory medicine including clinical and molecular genetics and makes appropriate recommendations to the Commissioner of Food and Drugs.
Reviews and evaluates data concerning the safety and effectiveness of marketed and investigational devices for use in the neurological system and makes appropriate recommendations to the Commissioner of Food and Drugs.
Reviews and evaluates data concerning the safety and effectiveness of marketed and investigational orthopedic and rehabilitation devices and makes appropriate recommendations to the Commissioner of Food and Drugs.
Reviews and evaluates data concerning the safety and effectiveness of marketed and investigational diagnostics or therapeutic radiological and nuclear medicine devices and makes appropriate recommendations to the Commissioner of Food and Drugs.
Persons nominated for the device panels should be full-time employees of firms that manufacture products that would come before the panel, or consulting firms that represent manufacturers, or have similar appropriate ties to industry.
Any industry organization interested in participating in the selection of an appropriate nonvoting member to represent industry interests should send a letter stating that interest to the FDA contact (see
Individuals may self nominate and/or an organization may nominate one or more individuals to serve as a nonvoting industry representative. Contact information, a current curriculum vitae, and the name of the Committee of interest may be submitted to the FDA Advisory Committee Membership Nomination Portal (see
This notice is issued under the Federal Advisory Committee Act (5 U.S.C. app. 2) and 21 CFR part 14, relating to advisory committees.
Electronic Government Office, HHS.
Notice.
In compliance with section 3507(a)(1)(D) of the Paperwork Reduction Act of 1995, the Electronic Government Office (EGOV), Department of Health and Human Services, has submitted an Information Collection Request (ICR), described below, to the Office of Management and Budget (OMB) for review and approval. The ICR is for a 3-year extension for OMB Control Number 4040-0005. The ICR will expire on July 31, 2016. The ICR also requests categorizing the form as a common form, meaning HHS will only request approval for its own use of the form rather than aggregating the burden estimate across all Federal Agencies as was done for previous actions on this OMB control number. Comments submitted during the first public review of this ICR will be provided to OMB. OMB will accept further comments from the public on this ICR during the review and approval period.
Comments on the ICR must be received on or before April 18, 2016.
Submit your comments to
Information Collection Clearance staff,
When submitting comments or requesting information, please include the OMB control number 4040-0005. Form is available
HHS does not use the form; however, HHS estimates that the SF-424 Application for Federal Assistance—Individual's will take 1 hour to complete.
Once OMB approves the use of this common form, federal agencies may request OMB approval to use this common form without having to publish notices and request public comments for 60 and 30 days. Each agency must account for the burden associated with their use of the common form.
EGOV specifically requests comments on (1) the necessity and utility of the proposed information collection for the proper performance of the agency's functions, (2) the accuracy of the estimated burden, (3) ways to enhance the quality, utility, and clarity of the information to be collected, and (4) the use of automated collection techniques or other forms of information technology to minimize the information collection burden.
Pursuant to section 10(d) of the Federal Advisory Committee Act, as amended (5 U.S.C. App.), notice is hereby given of the following meeting.
The meeting will be closed to the public in accordance with the provisions set forth in sections 552b(c)(4) and 552b(c)(6), Title 5 U.S.C., as amended. The grant applications and the discussions could disclose confidential trade secrets or commercial property such as patentable material, and personal information concerning individuals associated with the grant applications, the disclosure of which would constitute a clearly unwarranted invasion of personal privacy.
Pursuant to section 10(d) of the Federal Advisory Committee Act, as amended (5 U.S.C. App.), notice is hereby given of the following meetings.
The meetings will be closed to the public in accordance with the provisions set forth in sections 552b(c)(4) and 552b(c)(6), Title 5 U.S.C., as amended. The grant applications and the discussions could disclose confidential trade secrets or commercial property such as patentable material,
Pursuant to section 10(d) of the Federal Advisory Committee Act, as amended (5 U.S.C. App.), notice is hereby given of the following meeting.
The meeting will be closed to the public in accordance with the provisions set forth in sections 552b(c)(4) and 552b(c)(6), Title 5 U.S.C., as amended. The grant applications and the discussions could disclose confidential trade secrets or commercial property such as patentable material, and personal information concerning individuals associated with the grant applications, the disclosure of which would constitute a clearly unwarranted invasion of personal privacy.
Pursuant to section 10(d) of the Federal Advisory Committee Act, as amended (5 U.S.C. App.), notice is hereby given of the following meeting.
The meeting will be closed to the public in accordance with the provisions set forth in sections 552b(c)(4) and 552b(c)(6), Title 5 U.S.C., as amended. The grant applications and the discussions could disclose confidential trade secrets or commercial property such as patentable material, and personal information concerning individuals associated with the grant applications, the disclosure of which would constitute a clearly unwarranted invasion of personal privacy.
Pursuant to section 10(d) of the Federal Advisory Committee Act, as amended (5 U.S.C. App.), notice is hereby given of the following meetings.
The meetings will be closed to the public in accordance with the provisions set forth in sections 552b(c)(4) and 552b(c)(6), Title 5 U.S.C., as amended. The grant applications and the discussions could disclose confidential trade secrets or commercial property such as patentable material, and personal information concerning individuals associated with the grant applications, the disclosure of which would constitute a clearly unwarranted invasion of personal privacy.
Pursuant to section 10(d) of the Federal Advisory Committee Act, as amended (5 U.S.C. App.), notice is hereby given of the following meetings.
The meetings will be closed to the public in accordance with the provisions set forth in sections 552b(c)(4) and 552b(c)(6), Title 5 U.S.C., as amended. The grant applications and the discussions could disclose confidential trade secrets or commercial property such as patentable material, and personal information concerning individuals associated with the grant applications, the disclosure of which would constitute a clearly unwarranted invasion of personal privacy.
Pursuant to section 10(d) of the Federal Advisory Committee Act, as amended (5 U.S.C. App.), notice is hereby given of the following meeting.
The meeting will be closed to the public in accordance with the provisions set forth in sections 552b(c)(4) and 552b(c)(6), Title 5 U.S.C., as amended. The grant applications and the discussions could disclose confidential trade secrets or commercial property such as patentable material, and personal information concerning individuals associated with the grant applications, the disclosure of which would constitute a clearly unwarranted invasion of personal privacy.
Pursuant to section 10(d) of the Federal Advisory Committee Act, as amended (5 U.S.C. App.), notice is hereby given of the following meetings.
The meetings will be closed to the public in accordance with the provisions set forth in sections 552b(c)(4) and 552b(c)(6), Title 5 U.S.C., as amended. The grant applications and the discussions could disclose confidential trade secrets or commercial property such as patentable material, and personal information concerning individuals associated with the grant applications, the disclosure of which would constitute a clearly unwarranted invasion of personal privacy.
Coast Guard, Department of Homeland Security.
Notice of Federal Advisory Committee meeting.
The Merchant Mariner Medical Advisory Committee and its working groups will meet to discuss matters relating to medical certification determinations for issuance of licenses, certificates of registry, merchant mariners' documents, medical standards and guidelines for the physical qualifications of operators of commercial vessels, medical examiner education, and medical research. The meetings will be open to the public. DATES: The Merchant Mariner Medical Advisory Committee and its working groups are scheduled to meet on Monday, March 14 and Tuesday, March 15, 2016, from 8 a.m. to 5:15 p.m. and 8 a.m. to 5 p.m. Please note that these meetings may adjourn early if the committee has completed its business.
The meetings will be held at the Crowley Maritime Corporation, 1st Floor Conference Room, 9487 Regency Square Blvd., Jacksonville, FL 32225 (
Please be advised that all attendees are required to check-in to the visitor's booth located to the right of the main building entrance. All attendees will be required to provide a government-issued picture identification card in order to gain admittance to the building. For planning purposes, please notify the Merchant Mariner Medical Advisory Committee Alternate Designated Federal Officer of your attendance as soon as possible using the contact information provided in the
For information on facilities or services for individuals with disabilities or to request special assistance at the meeting, contact the Alternate Designated Federal Officer as soon as possible.
To facilitate public participation, we are inviting public comment on the issues to be considered by the committee as listed in the “Agenda” section below. Written comments for distribution to committee members must be submitted no later than March 7, 2016, if you want the committee members to be able to review your comments before the meeting, and must be identified by docket number USCG-2016-0122. Written comments may be submitted using the Federal eRulemaking Portal:
A public comment period will be held on March 14, 2016, from approximately 11:30 a.m.-12 p.m. and March 15, 2016 from approximately 2:15 p.m.-2:45 p.m. Speakers are requested to limit their comments to 5 minutes. Please note that the public comment period may end before the time indicated, following the last call for comments. Additionally, public comment will be sought throughout the meeting as specific issues are discussed by the committee. Contact Lieutenant Ashley Holm as indicated below to register as a speaker.
Lieutenant Ashley Holm, Alternate Designated Federal Officer for the Merchant Mariner Medical Advisory Committee, 2703 Martin Luther King Jr. Ave SE., Stop (7501), telephone 202-372-1128, fax 202-372-4908 or
Notice of this meeting is given under the
The agenda for the March 14, 2016 meeting is as follows:
(1) Opening remarks from Crowley Maritime leadership.
(2) Opening remarks from Coast Guard leadership.
(3) Opening remarks from the Designated Federal Officer.
(4) Roll call of committee members and determination of a quorum.
(5) Review of last full committee meeting's minutes.
(6) Introduction of new task(s).
(7) Presentation and discussion on marine casualty investigations and data analysis (could lead to future tasking for the committee).
(8) Public comment period.
(9) Presentation on mariner wellness.
(10) Working Groups addressing the following task statements may meet to deliberate-
(a) Task statement 13, Mariner Occupational Health Risk Analysis. This is a joint task statement with the Merchant Marine Personnel Advisory Committee.
(b) Task statement(s) requesting recommendations on training content for a Designated Medical Examiner program.
(c) Task statement requesting recommendations on guidance to mariners on over the counter medications, energy drinks/pills, diet aids, and dietary supplements.
(d) The Committee may receive new task statements from the Coast Guard, review the information presented on each issue, deliberate and formulate recommendations for the Department's consideration.
(10) Adjournment of meeting.
The agenda for the March 15, 2016 meeting is as follows:
(1) Continue work on Task Statements.
(2) Presentation from the Council on Chiropractic Education.
(3) Public comment period.
(4) By mid-afternoon, the Working Groups will report, and if applicable, make recommendations for the full committee to consider for presentation to the Coast Guard. The committee may vote on the working group's recommendations on this date. The public will have an opportunity to speak after each Working Group's Report before the full committee takes any action on each report.
(5) Closing remarks/plans for next meeting.
(6) Adjournment of Meeting.
National Protection and Programs Directorate, DHS.
Notice of availability.
DHS is announcing the availability of Cybersecurity Information Sharing Act of 2015 Interim Guidance Documents jointly issued with the Department of Justice (DOJ) in compliance with the Act (CISA), which authorizes the voluntary sharing and receiving of cyber threat indicators and defensive measures for cybersecurity purposes, consistent with certain protections, including privacy and civil liberty protections.
The CISA guidance documents may be found on
If you have questions about this notice, email Matthew Shabat at
The CISA requires the Secretary of DHS and the Attorney General to jointly develop and make publicly available—
• guidance to assist non-Federal entities and promote sharing of cyber threat indicators with the Federal Government;
• interim and final guidelines for the protection of privacy and civil liberties; and
• interim and final procedures related to the receipt of cyber threat indicators and defensive measures by the Government, which happen principally through the real-time DHS process, the existing DHS-operated Automated Indicator Sharing (AIS) initiative and may also occur through direct submissions to Federal agencies.
The CISA also requires the Secretary of DHS, the Attorney General, the Director of National Intelligence, and the Secretary of Defense, to jointly develop interim procedures to facilitate and promote the sharing of cyber threat indicators and defensive measures by the Federal Government.
On December 18, 2015, the President signed into law the Consolidated Appropriations Act, 2016, Public Law 114-113, which included at Division N, Title I the Cybersecurity Information Sharing Act of 2015 (CISA). Congress designed CISA to establish a voluntary cybersecurity information sharing process that encourages public and private sector entities to share cyber threat indicators and defensive measures while protecting privacy and civil liberties. The CISA requires various Executive Branch agencies to coordinate and create, within 60 days of enactment (
The CISA sec. 103 requires the Director of National Intelligence, the Secretary of Homeland Security, the Secretary of Defense, and the Attorney General, in consultation with the heads of designated Federal entities,
The CISA sec. 105(a)(1) requires the Secretary of Homeland Security and the Attorney General, in consultation with the heads of designated Federal entities, to jointly develop and issue interim policies and procedures relating to the receipt of cyber threat indicators and defensive measures by the Federal Government. These internal operational procedures describe general rules applicable to DHS and other Federal agencies and the operative processes of the DHS AIS system, including the statutory requirement for Federal agencies that receive cyber threat indicators and defensive measures to share them with other appropriate agencies.
The CISA sec. 105(a)(4) requires the Secretary of Homeland Security and the Attorney General to jointly develop and make publicly available guidance to assist non-Federal entities with sharing cyber threat indicators with Federal entities. This guidance includes explanations of how non-Federal entities can identify and share cyber threat indicators and defensive measures with the Federal Government in accordance with CISA and describes the protections non-Federal entities receive under CISA for sharing cyber threat indicators and defensive measures, including targeted liability protection and other statutory protections.
Finally, CISA sec. 105(b) requires the Secretary of Homeland Security and the Attorney General, in consultation with the Department Heads and Chief Privacy and Civil Liberties Officers of the designated Federal entities, to jointly develop and make publicly available interim guidelines relating to privacy and civil liberties that govern the receipt, retention, use, and dissemination of cyber threat indicators by a Federal entity. These privacy and civil liberties guidelines are consistent with the Fair Information Practice Principles (FIPPs) set forth in Appendix A of the “National Strategy for Trusted Identities in Cyberspace,” published by the President in April 2011.
The CISA guidance documents may be found on
Office of the Assistant Secretary for Housing—Federal Housing Commissioner, HUD.
Notice.
HUD is seeking approval from the Office of Management and Budget (OMB) for the information collection described below. In accordance with the Paperwork Reduction Act, HUD is requesting comment from all interested parties on the proposed collection of information. The purpose of this notice is to allow for 60 days of public comment.
Interested persons are invited to submit comments regarding this proposal. Comments should refer to the proposal by name and/or OMB Control Number and should be sent to: Colette Pollard, Reports Management Officer, QDAM, Department of Housing and Urban Development, 451 7th Street SW., Room 4176, Washington, DC 20410-5000; telephone 202-402-3400 (this is not a toll-free number) or email at
Theodore K. Toon, Director, Office of Multifamily Production, Department of Housing and Urban Development, 451 7th Street SW., Washington, DC 20410; email
Copies of available documents submitted to OMB may be obtained from Ms. Pollard.
This notice informs the public that HUD is seeking approval from OMB for the information collection described in Section A.
This notice is soliciting comments from members of the public and affected parties concerning the collection of information described in Section A on the following:
(1) Whether the proposed collection of information is necessary for the proper performance of the functions of the agency, including whether the information will have practical utility;
(2) The accuracy of the agency's estimate of the burden of the proposed collection of information;
(3) Ways to enhance the quality, utility, and clarity of the information to be collected; and
(4) Ways to minimize the burden of the collection of information on those who are to respond; including through the use of appropriate automated collection techniques or other forms of information technology,
HUD encourages interested parties to submit comment in response to these questions.
Section 3507 of the Paperwork Reduction Act of 1995, 44 U.S.C. Chapter 35.
Fish and Wildlife Service, Interior.
Notice of availability; request for comments.
We, the U.S. Fish and Wildlife Service, invite the public to comment on the following applications for recovery permits to conduct activities with the purpose of enhancing the survival of endangered species. The Endangered Species Act of 1973, as amended (Act), prohibits certain activities with endangered species unless a Federal permit allows such activity. The Act also requires that we invite public comment before issuing such permits.
To ensure consideration, please send your written comments by March 21, 2016.
Program Manager, Restoration and Endangered Species Classification, Ecological Services, U.S. Fish and Wildlife Service, Pacific Regional Office, 911 NE 11th Avenue, Portland, OR 97232-4181. Please refer to the permit number for the application when submitting comments.
Colleen Henson, Fish and Wildlife Biologist, at the above address, or by telephone (503-231-6131) or fax (503-231-6243).
The Act (16 U.S.C. 1531
A permit granted by us under section 10(a)(1)(A) of the Act authorizes the permittee to conduct activities (including take or interstate commerce)
We invite local, State, and Federal agencies and the public to comment on the following applications. Please refer to the permit number for the application when submitting comments.
Documents and other information submitted with these applications are available for review by request from the Program Manager for Restoration and Endangered Species Classification at the address listed in the
The applicant requests a permit amendment to take (capture, band, mark, measure, weigh, collect blood samples, radio-tag, release, recapture, and search for and monitor nests) Hawaiian gallinule (
The applicant requests a permit renewal with changes to take (capture, handle, and release) Borax Lake chub (
The applicant requests a permit amendment to take (survey, capture, mark, and release) Fender's blue butterfly (
The applicant requests a permit amendment to take (captive rear adults) Taylor's checkerspot butterflies (
All comments and materials we receive in response to this request will be available for public inspection, by appointment, during normal business hours at the address listed in the
Before including your address, phone number, email address, or other personal identifying information in your comment, you should be aware that your entire comment—including your personal identifying information—may be made publicly available at any time. While you can ask us in your comment to withhold your personal identifying information from public review, we cannot guarantee that we will be able to do so.
We provide this notice under section 10 of the Act (16 U.S.C. 1531
National Park Service, Interior.
Notice.
The Mount Holyoke College Art Museum, in consultation with the appropriate Indian tribes or Native Hawaiian organizations, has determined that the cultural item listed in this notice meets the definition of a sacred object and object of cultural patrimony. Lineal descendants or representatives of any Indian tribe or Native Hawaiian organization not identified in this notice that wish to claim this cultural item should submit a written request to the Mount Holyoke College Art Museum. If no additional claimants come forward, transfer of control of the cultural item to the lineal descendants, Indian tribes, or Native Hawaiian organizations stated in this notice may proceed.
Lineal descendants or representatives of any Indian tribe or Native Hawaiian organization not identified in this notice that wish to claim this cultural item should submit a written request with information in support of the claim to the Mount Holyoke College Art Museum at the address in this notice by March 21, 2016.
Aaron F. Miller, NAGPRA Coordinator, Mount Holyoke College Art Museum, 50 College Street, South Hadley, MA 01075, telephone (413) 538-3394, email
Notice is here given in accordance with the Native American Graves Protection and Repatriation Act (NAGPRA), 25 U.S.C. 3005, of the intent to repatriate a cultural item under the control of the Mount Holyoke College Art Museum that meets the definition of a sacred object and an object of cultural patrimony under 25 U.S.C. 3001.
This notice is published as part of the National Park Service's administrative responsibilities under NAGPRA, 25 U.S.C. 3003(d)(3). The determinations in this notice are the sole responsibility of the museum, institution, or Federal agency that has control of the Native American cultural item. The National Park Service is not responsible for the determinations in this notice.
In 2014, one cultural item was donated to the Mount Holyoke College Art Museum by the children of J. Donald Detenber, from Westborough, MA. Detenber was a collector and dealer in Native American objects, and it is unclear when and where he acquired the object. Detenber was most active in the 1980s and 1990s and purchased from various dealers and auction houses across the country. The sacred object/object of cultural patrimony is a woven cotton sash.
This type of textile was used primarily by the bride in the traditional Hopi wedding ceremony and can be seen in various photographs from the early 20th century. As part of the ceremony, cotton was collected from various members of the community and woven by a specific group of relatives. Another known use of these sashes is the Powamu Festival, centered on the seasonal planting of beans. One aspect of the ceremonies is the imitation of Katchinas (ancestral spirits). In some cases, men would don the sash to dress as female Katchina spirits or women in general. One such female Katchina is Angwusnasomtaka (Crow Mother), who is often represented with this type of sash. Based on the above definitions and a general knowledge of these objects being used in various types of ceremonies, there is a relationship of shared group identity that can be reasonably traced between the cultural item and the Hopi Tribe of Arizona.
Officials of the Mount Holyoke College Art Museum have determined that
• Pursuant to 25 U.S.C. 3001(3)(C), the one cultural item described above is a specific ceremonial objects needed by traditional Native American religious leaders for the practice of traditional Native American religions by their present-day adherents.
• Pursuant to 25 U.S.C. 3001(3)(D), the one cultural item described above has ongoing historical, traditional, or cultural importance central to the Native American group or culture itself, rather than property owned by an individual.
• Pursuant to 25 U.S.C. 3001(2), there is a relationship of shared group identity that can be reasonably traced between the sacred object and object of cultural patrimony and the Hopi Tribe of Arizona.
Lineal descendants or representatives of any Indian tribe or Native Hawaiian organization not identified in this notice that wish to claim this cultural item should submit a written request with information in support of the claim to Aaron F. Miller, NAGPRA Coordinator, Mount Holyoke College Art Museum, 50 College Street, South Hadley, MA 01075, telephone (413) 538-3394, email
The Mount Holyoke College Art Museum is responsible for notifying the Hopi Tribe of Arizona that this notice has been published.
National Park Service, Interior.
Notice.
The U.S. Department of Defense, Department of the Navy (DoN) has completed an inventory of human remains, in consultation with the Aleut Corporation, representatives of the Aleut Repatriation Committee, and the Cultural Heritage Director of the Aleutian/Pribilof Islands Association, Inc., as agents for the Native Village of Atka, AK, and has determined that there is a cultural affiliation between the human remains and members of the Native Village of Atka. Lineal descendants or representatives of any Indian tribe or Native Hawaiian organization not identified in this notice that wish to request transfer of control of these human remains should submit a written request to the DoN. If no additional requestors come forward, transfer of control of the human remains to the lineal descendants, Indian tribes, or Native Hawaiian organizations stated in this notice may proceed.
Lineal descendants or representatives of any Indian tribe or Native Hawaiian organization not identified in this notice that wish to request transfer of control of these human remains should submit a written request with information in support of the request to the DoN at the address in this notice by March 21, 2016.
Dr. Susan S. Hughes, Archaeologist, Department of the Navy, NAVFAC NW, 1101 Tautog Circle, Silverdale, WA 98315, telephone (360) 396-0083, email
Notice is hereby given in accordance with the Native American Graves Protection and Repatriation Act (NAGPRA), 25 U.S.C. 3003, of the completion of an inventory of human remains under the control of the DoN. The human remains were removed from the island of Attu, AK, in the Aleutian Islands.
This notice is published as part of the National Park Service's administrative responsibilities under NAGPRA, 25 U.S.C. 3003(d)(3). The determinations in this notice are the sole responsibility of the museum, institution, or Federal agency that has control of the Native American human remains. The National Park Service is not responsible for the determinations in this notice.
A detailed assessment of the human remains was made by the DoN professional staff in consultation with the Aleut Corporation, the Aleut Repatriation Committee, and the Cultural Heritage Director of the Aleutian/Pribilof Islands Association, Inc., as agents for the Native Village of Atka, AK.
In 1943, human remains representing, at minimum, one individual were removed from Attu Island, at the western end of the Aleutian Islands, AK. The human remains, a skull and associated mandible, came into the possession of William J. Madden II, Senior Medical Officer at the U.S. Naval Aerological Station, Attu, where they were used as an aid in the study of human skull anatomy. In a letter dated May 14, 1948, Dr. Madden states that the human remains were recovered by a civilian construction company while engaged in building a Coast Guard Station on Attu. A historic account of the Coast Guard construction of the Western Aleutian island chain (The Coast Guard at War: IV Loran Volume I Section III, Chapter 3) suggests that the skull may have come from an archeological site at Baxter Bay.
After the Battle of Attu in the spring of 1943, a U.S.C.G. LORAN Station was
The skull was transferred into the custody of the Yale University Peabody Museum in 1955 (Catalog No. ANTPA.000227), where it remained until 2014, when it was returned to the Department of the Navy, NAVFAC Northwest, to facilitate its repatriation.
The skull is represented by a nearly complete cranium and mandible belonging to a young female, aged 15 to 19 years. The dental wear, eruption and mandibular morphology are consistent with the mandible belonging with the cranium. There is damage to the ethmoid and the nasal conchae, with the inferior nasal conchae completely absent. The vomer is present but disarticulated. The sphenoid and right temporal show some postmortem damage. The zygomatic process of the right temporal is missing, as is the right mastoid; the left mastoid process is damaged but mostly present. The mandible is missing the condyles, the right mandibular angle, and its coronoid process. Most of the molars are present, but the incisors and canines were lost post-mortem.
The individual's age is based upon the unerupted third molars, unfused basal synchondrosis, and incomplete closure of the incisive suture of the palate. There is no clear evidence of chronic or acute health issues. The skull does reveal a small healed, depressed fracture located on the right parietal. The color and condition of the human remains suggests superficial interment with subsequent or partial exposure. Metric and nonmetric data support ethnic identification as Native American/Indigenous Alaska with closest affinity to females sampled from Wales, AK (Southeastern mainland; Aronsen and Kirkham 2014). No known individuals are identified. No funerary objects are associated with the human remains.
Radiocarbon dates from archeological sites on Attu Island reveal that the island was inhabited between 100 and 2000 years ago (Lefevre et al. 2001). The Department of the Navy has determined that the human remains are affiliated with the Unangax/Aleut people because they have a long history of living on the Aleutian Islands, including the island of Attu. When the 20th century Native Village of Attu at Chichagof Harbor was occupied by the Japanese in 1942, the Native inhabitants were removed to Japan. The village was not re-occupied after the war; its remaining inhabitants settling on Atka Island, the closest settlement to Attu Island (Aleut Repatriation Commission and Cultural Heritage Director, 2002).
Officials of the Department of the Navy have determined that:
• Pursuant to 25 U.S.C. 3001(9), the human remains described in this notice represent the physical remains of one individual of Native American ancestry.
• Pursuant to 25 U.S.C. 3001(2), there is a relationship of shared group identity that can be reasonably traced between the Native American human remains and Members of the Village of Atka, AK.
Lineal descendants or representatives of any Indian tribe or Native Hawaiian organization not identified in this notice that wish to request transfer of control of these human remains should submit a written request with information in support of the request to Dr. Susan S. Hughes, Department of the Navy NAVFAC NW, 1101 Tautog Circle, Silverdale, WA 98315, telephone (360) 396-0083, email
The Department of the Navy is responsible for notifying the Native Village of Atka, AK, through its agents, that this notice has been published.
National Park Service, Interior.
Notice.
The Thomas Burke Memorial Washington State Museum (Burke Museum) has completed an inventory of human remains, in consultation with the appropriate Indian tribes or Native Hawaiian organizations, and has determined that there is no cultural affiliation between the human remains and any present-day Indian tribes or Native Hawaiian organizations. Representatives of any Indian tribe or Native Hawaiian organization not identified in this notice that wish to request transfer of control of these human remains should submit a written request to the Burke Museum. If no additional requestors come forward, transfer of control of the human remains to the Indian tribes or Native Hawaiian organizations stated in this notice may proceed.
Representatives of any Indian tribe or Native Hawaiian organization not identified in this notice that wish to request transfer of control of these human remains should submit a written request with information in support of the request to the Burke Museum at the address in this notice by March 21, 2016.
Peter Lape, Burke Museum, University of Washington, Box 353010, Seattle, WA 98195, telephone (206) 685-3849x2,
Notice is here given in accordance with the Native American Graves Protection and Repatriation Act (NAGPRA), 25 U.S.C. 3003, of the completion of an inventory of human remains under the control of the Burke Museum, University of Washington, Seattle, WA. The human remains were possibly removed from the San Juan Islands, San Juan Island County, WA.
This notice is published as part of the National Park Service's administrative
A detailed assessment of the human remains was made by the Burke Museum professional staff in consultation with representatives of Lummi Tribe of the Lummi Reservation; Muckleshoot Indian Tribe (previously listed as the Muckleshoot Indian Tribe of the Muckleshoot Reservation, Washington); Nooksack Indian Tribe; Samish Indian Nation (previously listed as the Samish Indian Tribe, Washington); Sauk-Suiattle Indian Tribe; Snoqualmie Indian Tribe (previously listed as the Snoqualmie Tribe, Washington); Stillaguamish Tribe of Indians of Washington (previously listed as the Stillaguamish Tribe of Washington); Suquamish Indian Tribe of the Port Madison Reservation; Swinomish Indian Tribal Community (previously listed as the Swinomish Indians of the Swinomish Reservation of Washington); Tulalip Tribes of Washington (previously listed as the Tulalip Tribes of the Tulalip Reservation, Washington); and Upper Skagit Indian Tribe, (all hereafter referred to as the “The Tribes”).
On an unknown date prior to 1995, human remains representing, at minimum, one individual were possibly removed from San Juan Islands, San Juan Island County, Washington. These remains were identified in 1995 while completing an inventory for NAGPRA compliance. These human remains were located in a box of material marked “Anian Island Burial 3F.” The human remains were in a paper-bag marked “Burial 3”. Also written on the bag in the same pencil, but crossed out, is, “SJ-1, Finds, 7/18/46.”. These human remains to do not match any of the records for the Anian Island burial. They also do not match “Burial 3” from Arden King's 1946 excavations at 45-SJ-1 and there is no mention of burials being found on 7/18/1946 in the field documents. The condition of these human remains is consistent with other burials in shell middens from this area. Additional information provided during consultation indicated this individual was likely buried on the San Juan Islands. The Burke Museum is unable to make a cultural affiliation due to the lack of contextual and exact location information from which the burial was removed. No known individuals were identified. No associated funerary objects are present.
Officials of the Burke Museum have determined that:
• Pursuant to 25 U.S.C. 3001(9), the human remains described in this notice are Native American based on osteological evidence and museum collecting and accessioning history.
• Pursuant to 25 U.S.C. 3001(9), the human remains described in this notice represent the physical remains of one individual of Native American ancestry.
• Pursuant to 25 U.S.C. 3001(2), a relationship of shared group identity cannot be reasonably traced between the Native American human remains and any present-day Indian tribe.
• Treaties, Acts of Congress, or Executive Orders, indicate that the land from which the Native American human remains were removed is the aboriginal land of The Tribes. The Treaty of Point Elliot was signed on January 22, 1855 by representatives from The Tribes, and ceded aboriginal land included the San Juan Islands region.
• Pursuant to 43 CFR 10.11(c)(1), the disposition of the human remains may be to The Tribes.
Representatives of any Indian tribe or Native Hawaiian organization not identified in this notice that wish to request transfer of control of these human remains should submit a written request with information in support of the request to Peter Lape, Burke Museum, University of Washington, Box 353010, Seattle, WA 98195, telephone (206) 685-3849 x2,
The Burke Museum is responsible for notifying The Tribes that this notice has been published.
National Park Service, Interior.
Findings and recommendations.
The National Park Service is publishing this notice as part of its administrative responsibilities pursuant to the Native American Graves Protection and Repatriation Act (NAGPRA or the Act). The recommendations, findings, and actions in this notice are advisory only and are not binding on any person. The Native American Graves Protection and Repatriation Review Committee (Review Committee) found that certain human remains and associated items are culturally affiliated with The Osage Nation and that the State of Missouri Department of Natural Resources, State Historic Preservation Office should determine the most appropriate claimant—The Osage Nation or the Indian tribes comprising the Sac and Fox NAGPRA Confederacy—using the criteria under section 7(a)(4) of the Act.
The Review Committee meeting transcript containing the proceedings and Review Committee deliberation and findings are available online at
The recommendations, findings, and actions of the Review Committee are advisory only and not binding on any person. These advisory findings and recommendations do not necessarily represent the views of the National Park Service or Secretary of the Interior. The National Park Service and the Secretary of the Interior have not taken a position on these matters.
The Review Committee was established by Section 8 of the Act, and is an advisory body governed by the Federal Advisory Committee Act. At its November 18, 2015, public meeting in Norman, OK, the Review Committee heard a request from The Osage Nation as an affected party. The issues before the Review Committee were (1) whether the human remains and associated items from the Clarksville Mound Group (site 23PI6) are culturally affiliated with The Osage Nation; and (2) whether the
Between 1962 and 1996, human remains representing, at minimum, 29 individuals were removed from the Clarksville Mound Group (site 23PI6) in Pike County, MO. The Clarksville Mound Group was originally recorded in 1952, and described as a group of six mounds. In 1962, the site was bulldozed in order to develop a sky-ride and tourist attraction, and five of the six mounds were destroyed. In 1995 and 1996, the City of Clarksville, the owner of the site, contacted the Missouri Department of Natural Resources, State Historic Preservation Office (SHPO) for assistance after terminating the lease to the tourist attraction. Human remains were eroding out of the damaged mound, and due to the severity of the erosion problem, the SHPO and the City of Clarksville decided to undertake excavations to remove the threatened burials. The excavations were expanded as more burials were discovered. During the excavations, human remains representing, at minimum, 22 individuals were removed from the site. The two associated funerary objects are one lot of ancalusa shell beads and one Scallorn point. In 2002, additional human remains representing, at minimum, four individuals were transferred to the SHPO by a local collector who had been on the site in 1962. In 2006, additional human remains from the site representing, at minimum, three individuals were transferred to the SHPO by the University of Missouri-Columbia.
On February 21, 2013, the Sac & Fox Nation of Oklahoma, the Sac & Fox Tribe of the Mississippi in Iowa, and the Sac & Fox Nation of the Missouri in Kansas, through the Sac and Fox NAGPRA Confederacy, submitted a request for repatriation of all the human remains and associated funerary objects from the Clarksville Mound Group (site 23PI6), citing a relationship of shared group identity (cultural affiliation). On July 30, 2013, the SHPO published a Notice of Inventory Completion in the
In August 2015, The Osage Nation requested that the Review Committee make a finding of fact regarding the human remains and associated funerary objects removed from Clarksville Mound Group (site 23PI6) in Pike County, MO. The Designated Federal Officer for the Review Committee agreed to the request.
At its November 18, 2015 meeting, the Review Committee considered the request. The issues before the Review Committee were (1) whether the human remains and associated items from the Clarksville Mound Group (site 23PI6) are culturally affiliated with The Osage Nation; and (2) whether the appropriate disposition of human remains and associated items from the Clarksville Mound Group (site 23PI6) is to The Osage Nation or the Indian tribes comprising the Sac and Fox NAGPRA Confederacy.
U.S. International Trade Commission.
Notice.
Notice is hereby given that the U.S. International Trade Commission has received a complaint entitled
Lisa R. Barton, Secretary to the Commission, U.S. International Trade Commission, 500 E Street SW., Washington, DC 20436, telephone (202) 205-2000. The public version of the complaint can be accessed on the Commission's Electronic Document Information System (EDIS) at EDIS,
General information concerning the Commission may also be obtained by accessing its Internet server at United States International Trade Commission (USITC) at USITC.
The Commission has received a complaint and a submission pursuant to section 210.8(b) of the Commission's Rules of Practice and Procedure filed on behalf of Immersion Corporation on February 11, 2016. The complaint alleges violations of section 337 of the Tariff Act of 1930 (19 U.S.C. 1337) in the importation into the United States, the sale for importation, and the sale within the United States after importation of certain mobile electronic devices incorporating haptics (including smartphones and smartwatches) and components thereof. The complaint names as respondents Apple Inc. of Cupertino, CA; AT&T Inc. of Dallas, TX; and AT&T Mobility LLC of Atlanta, GA. The complainant requests that the Commission issue a limited exclusion order and cease and desist orders.
Proposed respondents, other interested parties, and members of the public are invited to file comments, not to exceed five (5) pages in length, inclusive of attachments, on any public interest issues raised by the complaint or section 210.8(b) filing. Comments should address whether issuance of the relief specifically requested by the complainant in this investigation would affect the public health and welfare in the United States, competitive conditions in the United States economy, the production of like or directly competitive articles in the United States, or United States consumers.
In particular, the Commission is interested in comments that:
(i) Explain how the articles potentially subject to the requested remedial orders are used in the United States;
(ii) identify any public health, safety, or welfare concerns in the United States relating to the requested remedial orders;
(iii) identify like or directly competitive articles that complainant, its licensees, or third parties make in the United States which could replace the subject articles if they were to be excluded;
(iv) indicate whether complainant, complainant's licensees, and/or third party suppliers have the capacity to replace the volume of articles potentially subject to the requested exclusion order and/or a cease and desist order within a commercially reasonable time; and
(v) explain how the requested remedial orders would impact United States consumers.
Written submissions must be filed no later than by close of business, eight calendar days after the date of publication of this notice in the
Persons filing written submissions must file the original document electronically on or before the deadlines stated above and submit 8 true paper copies to the Office of the Secretary by noon the next day pursuant to section 210.4(f) of the Commission's Rules of Practice and Procedure (19 CFR 210.4(f)). Submissions should refer to the docket number (“Docket No. 3120”) in a prominent place on the cover page and/or the first page. (
Any person desiring to submit a document to the Commission in confidence must request confidential treatment. All such requests should be directed to the Secretary to the Commission and must include a full statement of the reasons why the Commission should grant such treatment.
This action is taken under the authority of section 337 of the Tariff Act of 1930, as amended (19 U.S.C. 1337), and of sections 201.10 and 210.8(c) of the Commission's Rules of Practice and Procedure (19 CFR 201.10, 210.8(c)).
By order of the Commission.
On July 23, 2014, the Deputy Assistant Administrator, Office of Diversion Control, issued an Order to Show Cause to Hatem M. Ataya (Respondent), of Lapeer, Michigan. ALJ Ex. 1, at 1. The Show Cause Order proposed the revocation of Respondent's DEA Certificates of Registration, pursuant to which he is authorized to dispense controlled substances in schedules II through V, as a practitioner, at the registered address of 971 Baldwin Road, Lapeer, Michigan (FA2278201), and at the registered address of 3217 W. M-55 Suite B, West Branch, Michigan (BA7776353), on the ground that he has committed acts which render his registration inconsistent with the public interest.
The Show Cause Order alleged that from 2010 through 2013, Respondent “repeatedly violated [his] obligation under federal law by prescribing controlled substances to [his] patients outside of the normal course of professional medical practice.”
In addition, the Show Cause Order alleged that on March 26, 2013, Respondent was interviewed by a DEA Diversion Investigator and a local Detective.
Following service of the Show Cause Order, Respondent timely requested a hearing on the allegations. ALJ Ex. 2. The matter was placed on the docket of the Office of Administrative Law Judges and assigned to Administrative Law Judge (ALJ) Christopher B. McNeil, who commenced to conduct pre-hearing procedures and ordered the parties to submit their respective pre-hearing statements. GX 3. Thereafter, the parties submitted their pre-hearing and supplemental pre-hearing statements. The parties also filed various motions, the most significant of these being (given the issues raised by the Parties in their Exceptions), the Government's Motion to Exclude Respondent's Witnesses (ALJ Ex. 41).
Also, on September 29, 2014, the ALJ conducted an on-the-record conference with the Parties at which he set the initial date for the evidentiary phase of the proceeding. Tr. 1, 16-17 (Sept. 29, 2014). During the conference, the ALJ authorized the taking of testimony at either the Agency's Arlington, Virginia hearing facility or “by video-teleconferencing in the Detroit DEA Office.”
On November 3, 2014, the ALJ conducted a further on-the-record conference during which he reviewed the parties' proposed stipulations and ruled on the Government's Motion to Exclude Respondent's Witnesses.
The Government also sought to exclude the testimony of Ms. Michelle Ann Richards, who, according to Respondent, would “testify that she is certified in healthcare compliance consulting, coding, and office management,” and “that she was retained by Respondent to do risk assessment audit and risk mitigation for his practice.” ALJ Ex. 39, at 3. Respondent also stated that Ms. Richards would testify that she had “provided compliance training to Respondent's staff [and] that she is continuing to monitor and implement changes to ensure [his] medical practice with all State and Federal laws.” Tr. 39. In addition to the ground that Respondent had not adequately summarized Ms. Richards' testimony, the Government also argued that the testimony should be barred because Respondent had represented that he “intend[ed] to testify that he has never been out of compliance with such laws,” and that his “ `care and treatment [of the five patients] at all times comported with reasonable and minimally accepted standards and that all prescriptions were issued for a legitimate medical purpose by a registered physician within the course of professional practice.' ” ALJ Ex. 42, at 4-5 (Gov. Mot.) (quoting Resp. Pre-Hearing Statement, at 3-4 (Sept. 15, 2014)). Continuing, the Government reasoned that under agency precedent, “ `mitigation' evidence is not admissible unless and until the registrant fully and unequivocally accepts responsibility for the wrongful or unlawful conduct on which registration consequences are sought.”
The ALJ granted the Government's motion, agreeing with both of the Government's arguments. Specifically, the ALJ agreed that Respondent had failed to describe Ms. Richards' testimony “with sufficient particularity” and thus had not complied with his prehearing order. Tr. 39 (Nov. 3, 2014). Also, the ALJ explained that because Respondent intended to testify that in prescribing to the five patients he had “at all times comported with reasonable and minimally accepted standards” and that all of the prescriptions were issued within the usual course of professional practice and for a legitimate medical purpose, this “compels the conclusion that Respondent does not accept responsibility for any failure to conform to the requirements of the” CSA.
Notably, during the conference, the ALJ did not address Respondent's contention that the ALJ had misinterpreted the Agency's precedents, and that if the case law actually required him to admit to misconduct which he did not engage in, “then that precedent is inconsistent with procedural due process.” ALJ Ex. 45, at 1 (Resp.'s Response in Opposition to Govt's Mot. to Exclude Resp.'s Witnesses). Nor did the ALJ address Respondent's suggestion that he “defer” his ruling “until the hearing itself,” at which time the ALJ and the parties would be in “a better position to determine whether” he “ha[d] sufficiently titrated his contrition to permit the introduction of such testimony.”
Finally, the Government moved to exclude the testimony of two physicians who Respondent proposed would testify on his behalf as experts. While Respondent identified some eight areas on which he “anticipated” that the experts would testify, ALJ Ex. 39, at 3-5; the Government argued that the disclosure was inadequate because “Respondent has not disclosed any conclusions that the witnesses have actually reached regarding the prescribing conduct at issue.” ALJ Ex. 42, at 6. The Government further argued that “[i]t remains a mystery if these doctors have actually reached any
The ALJ granted the Government's motion, reasoning that he could not “tell from the supplemental prehearing statement which witness will espouse each of the opinions presented in the supplemental prehearing statement” and “whether either of the witnesses has a sufficient foundation, obtained through the review of patient records, or otherwise, to express the opinions presented in the supplemental prehearing statement.” Tr. 42. The ALJ also explained that he could not tell which professional standards the witnesses were relying on to reach their opinions.
On November 17-18, 2015, the ALJ presided over the evidentiary phase of the proceeding, conducting a video-teleconference with he and the reporter being present in Arlington, Virginia, and the witnesses (including Respondent) and the parties' counsels present at the DEA Detroit, Michigan Field Division Office.
At the hearing, the Government called four witnesses to testify, including Dr. Eugene O. Mitchell, who was accepted as an expert in pain medicine. The Government also submitted for the record an extensive amount of documentary evidence including,
Respondent testified on his own behalf. He also submitted several exhibits for the record. After the hearing, both parties submitted briefs containing their proposed findings of fact and conclusions of law.
Thereafter, the ALJ issued his Recommended Decision (hereinafter cited as R.D.). Therein, the ALJ found that the Government's evidence with respect to Factors Two (Respondent's experience in dispensing controlled substances) and Four (compliance with applicable laws related to controlled substances) supported the conclusion that “Respondent's continued registration would be inconsistent with the public interest.” R.D. 66-68.
More specifically, with respect to Factor Two, the ALJ found that “Respondent demonstrated a material lack of . . . experience regarding a prescribing source's responsibilities to resolve red flags when prescribing controlled substances for persons presenting with symptoms of chronic pain and terminate from his practice patients whose drug-seeking behavior indicates the potential for abuse or diversion (or both) of controlled substances.”
As for Factor Five—such other conduct which may threaten public health or safety—the ALJ found that the Government had not proved the allegation that Respondent made various false statements to the Diversion Investigator and Detective.
The ALJ thus concluded that “the Government has established its
Both parties filed Exceptions to the ALJ's Recommended Decision. Thereafter, the record was forwarded to my Office for Final Agency Action.
On review of the record, I noted that it contained no evidence as to whether Respondent is currently authorized under Michigan law to dispense controlled substances. Order at 1 (Nov. 10, 2015). Accordingly, I directed the parties to address whether Respondent currently possesses authority under Michigan law to dispense controlled substances and if Respondent does not possess such authority, to address what consequence attaches for this proceeding.
On November 17, 2015, the Government submitted its Response. Therein, the Government noted that on July 6, 2015, the Michigan Department of Licensing and Regulatory Affairs had filed an Administrative Complaint with the Board of Medicine Disciplinary Subcommittee. Govt's. Resp., at 7-8; Govt's Resp. Ex. 3, at 8-14
Having considered the record in its entirety, including the parties' Exceptions, as well as the recent action taken by the Michigan Board of Medicine, I issue this Decision and Final Order. I agree with the ALJ that the record supports findings that Respondent ignored multiple red flags of abuse and/or diversion with respect to each of the five patients (FoF #2). I also agree that the record supports the ALJ's factual findings specific to Respondent's prescribing of controlled substances to each of the five patients (FOF#s 3, 4, 5, 6, and 7), as well as his legal conclusions that Respondent acted outside of the usual course of professional practice and lacked a legitimate medical purpose in prescribing controlled substances to each of the five patients in violation of 21 CFR 1306.04(a).
With respect to Respondent's rebuttal case, for reasons explained below, I find troubling the ALJ's handling of the issue of whether Respondent has adequately accepted responsibility for his misconduct. And as for the ALJ's ruling barring Respondent from presenting evidence of his remedial measures, I agree with the ALJ that Respondent did not sufficiently disclose the scope of the proposed testimony. While this alone is sufficient reason to reject Respondent's exception, the ALJ further reasoned that under the Agency's precedent, Respondent is barred from introducing evidence of his remedial measures absent his admission to the allegations before the Government was even required to put on its evidence. Contrary to the ALJ's understanding, while a respondent's failure to acknowledge his misconduct renders evidence of his remedial measures irrelevant, the Agency has never held that a respondent must admit to his misconduct prior to even being able to test the Government's evidence at the hearing.
I reject, however, Respondent's contention that a remand is warranted for multiple reasons. First, as explained above, I agree with the ALJ's conclusion that Respondent did not adequately disclose the scope of the proposed testimony on the adequacy of his remedial measures. Second, even were I to credit Respondent's admissions at the hearing and give weight to his testimony regarding the remedial measures he has undertaken, I would nonetheless find that his conduct was so egregious that the protection of the public interest warrants the revocation of his registrations and the denial of his pending applications. Finally, because of the recent action of the Michigan Board of Medicine, Respondent is precluded from being registered because he no longer holds authority under state law to dispense controlled substances, and thus evidence of his acceptance of responsibility and remedial measures is irrelevant.
Respondent was formerly licensed as a physician by the Michigan Board of Medicine. However, on July 6, 2015, the Bureau of Professional Licensing, acting on behalf of the Michigan Department of Professional Licensing and Regulatory Affairs, filed a complaint against Respondent. Administrative Complaint,
Respondent currently holds two DEA practitioner's registrations, pursuant to which he is authorized to dispense controlled substances in schedules II through V. GX 4, at 1-2. The first of these (BA7776353) is for the registered location of 5097 Miller Road, Flint, Michigan and does not expire until June 30, 2017.
Respondent first came to the attention of law enforcement on January 5, 2012, when a Detective with the City of Lapeer Police Department responded to the death of R.J.H., one of the patients identified in the Show Cause Order. Tr. 90; ALJ Ex. 1, at 1-2. According to the Detective, he knew R.J.H. from his experience in law enforcement and knew him to be an abuser of both “prescription drugs [and] illegal drugs.” Tr. 93. The Detective testified that R.J.H. bore no signs of external injuries and there was no evidence that injuries had led to his death.
On January 22, 2012, the Detective responded to the death of J.W. Tr. 95. The authorities found two pill bottles in J.W.'s coat, as well as marijuana.
During his investigation, the Detective determined that on January 19 (three days earlier), J.W. had obtained prescriptions from Respondent for 120 methadone 10 and 120 clonazepam 1.
During the course of his investigation, the Detective spoke with both J.W.'s mother and niece. The Detective testified that J.W.'s mother said that J.W. did not like methadone and usually sold it to buy other drugs.
J.S. subsequently testified that her uncle's drug problem “was obvious” and that “[e]verybody knew.”
The Detective also testified regarding an investigation conducted by a subordinate into the death of R.K. on or about July 21, 2012.
The Detective also obtained a MAPS report for R.K.
The Detective testified that because his agency did not have a lot of experience in prescription drug investigations, after R.K.'s death, he sought the assistance of DEA, and on August 13, 2012, met with a DEA Diversion Investigator (DI). Tr. 102. Two days after the meeting, the mother of another of Respondent's patients (J.L.H.) contacted the Lapeer Police and reported that she had taken her daughter to see Respondent the day before and that he had issued her prescriptions for methadone, tramadol and clonazepam.
Several months later, the Detective obtained a warrant to search Respondent's Lapeer office for several patient charts, and on March 26, 2013, the Lapeer Police Department, DEA, and members of the Thumb Narcotics Unit (a local multijurisdictional task force) executed the warrant.
During the search of the Lapeer office, the Detective determined that several of the patient files that were being sought under the warrant were not at that office.
The Government also called the DI who worked with the Detective on the investigation. The DI testified that she obtained MAPS reports for Respondent and found that they showed that he prescribed “a lot of combinations of prescriptions for [m]ethadone, [h]ydrocodone, and . . . [a]lprazolam” and that the patients were “getting them on a regular basis.”
The DI testified that “many of the charts contained information that [showed] that the patients were not taking the controlled substances as they had been prescribed, or that they had drug addiction issues, or they were narcotic dependent, or any of a number of red flags that were indicated in the charts, and then we sent the patient charts out for expert review.”
The DI testified that the patient records included evidence that pharmacies had called Respondent raising issues of whether the patients “were doctor shopping or obtaining refills early.”
The DI further testified that in reviewing the patient files she found evidence of other violations of the Controlled Substance Act and DEA regulations. Tr. 172-73. These included instances in which Respondent authorized more than five refills on a prescription; instances in which he issued early refills; instances in which he failed to include a patient's address, which is required information on a prescription; and instances in which Respondent post-dated prescriptions.
The Government called Dr. Eugene O. Mitchell, Jr., who testified as an expert on pain management. Dr. Mitchell received a Bachelor of Science in Biochemistry in 1975 from the University of Florida and a Bachelor of Science in Medicine in 1979 from the University of Florida's Physician's Assistant Program. GX 25, at 1. Dr. Mitchell subsequently obtained a Doctor of Medicine in 1985 from the Wayne State University School of Medicine.
Dr. Mitchell holds a medical license issued by the State of Michigan and is board certified in both anesthesiology and pain medicine.
Since February 2001, Dr. Mitchell has held the position of Clinical Assistant Professor in the Department of Anesthesiology, Division of Interventional Pain Medicine, at the University of Michigan Medical Center.
Dr. Mitchell testified “all controlled substances have the risk of significant morbidities including death from overdose,” “withdrawal from their use,” and “addiction.
Dr. Mitchell further testified that there are various compliance tools that he uses to determine whether patients are abusing or diverting controlled substances. The first of these is a “medication agreement” between the physician and the patient which sets forth the “criteria that [the patient] will adhere to” while “being prescribed controlled substances.”
Dr. Mitchell also testified that in Michigan, a task force of physicians developed Guidelines for the “appropriate prescribing” of controlled substances for the treatment of pain.
Dr. Mitchell then testified regarding the “typical steps taken by doctors in treating patients who suffer from chronic pain.” Tr. 247. Dr. Mitchell testified that when a new patient seeks treatment, a physician “take[s] a detailed history” and asks the patient “to bring [his/her] records” including imaging findings. Tr. 247;
Dr. Mitchell testified that the “standard medical doctoring for a new patient encounter” includes a “review of [the patient's] systems” and “[a]n appropriately detailed physical examination.”
A complete medical history and physical examination must be conducted and documented in the medical record. The medical record should document the nature and intensity of the pain, current and past treatments for pain, underlying or coexisting diseases or conditions, the effect of the pain on physical and psychological function, and history of substance abuse. The medical record also should document the presence of one or more recognized medical indications for the use of a controlled substance.
GX 26, at 3. With respect to the creation of a treatment plan, the Guidelines state:
The written treatment plan should state objectives that will be used to determine treatment success, such as pain relief and improved physical
Re-emphasizing his earlier testimony, Dr. Mitchell testified that as part of the process of formulating a plan involving the long term prescribing of controlled substances, the physician reviews the medication agreement/opioid contract with the patient and explains that if the patient violates the agreement, the patient will be discharged from the practice.
[i]f the patient is determined to be at high risk for medication abuse or have a history of substance abuse, the physician may employ the use of a written agreement between physician and patient outlining patient responsibilities, including . . . urine/serum medication levels screening when requested; . . . number and frequency of all prescriptions, refills; and . . . reasons for which drug therapy may be discontinued (
GX 26, at 3. The Guidelines further advise physicians to periodically “monitor patient compliance in medication usage and related treatment plans.”
Regarding the five patients identified in the Show Cause Order, Dr. Mitchell testified that he reviewed the patient files including the visit notes, MAPS reports, and copies of the prescriptions which included the pharmacy labels.
With respect to R.E.H., the Government alleged that from August 5, 2010 through at least March 13, 2013, Respondent repeatedly prescribed controlled substances to the patient even after Respondent knew that R.E.H. “was engaged in the abuse and/or diversion of controlled substances, as well as prescription fraud.” ALJ Ex. 1, at 2. Specifically, the Government alleged that Respondent repeatedly prescribed methadone, a schedule II narcotic controlled substance, and other controlled substances to R.E.H., notwithstanding that he presented “numerous red flags of diversion and/or abuse.”
• R.E.H. repeatedly sought early refills;
• R.E.H. repeatedly claimed that his prescriptions were lost or stolen;
• pharmacists repeatedly contacted Respondent's office to report suspicious behavior by R.E.H.;
• MAPS reports in R.E.H.'s file corroborated reports that R.E.H. and his wife were committing prescription fraud;
• R.E.H. had been recently released from jail; and
• hospital records in his file showed that R.E.H. was using illegal drugs.
The Show Cause Order also alleged that R.E.H.'s patient file and the prescriptions issued to him show that Respondent prescribed methadone on R.E.H.'s “first visit without undertaking other actions typical of medical professionals[,] such as conducting and documenting a complete medical history and physical examination, requiring that R.E.H. (a self-identified addict) sign a pain management contract or undergo a drug test, running a MAPS search on R.E.H., or creating a written treatment plan.”
• Never subsequently required R.E.H. to sign a pain management contract;
• “repeatedly issued prescriptions to [him] with instructions to take his methadone `PRN'—thus directing that this self-identified addict should take this powerful opioid analgesic (properly used in scheduled dosages) on an `as needed' basis”;
• issued at least one prescription on a date when R.E.H.'s patient file indicates that he did not have an appointment;
• notwithstanding that he knew that R.E.H. was attempting to fill the prescriptions using his father's birthdate to avoid being detected, Respondent did not take the minimal preventative step of including R.E.H's address on his methadone prescriptions as required by state and federal law;
• issued a prescription for Xanax to be refilled six times, in violation of state and federal law; and
• falsified records to post-date a methadone prescription in order to provide R.E.H. with an early refill in violation of state and federal law, circumventing the efforts by his staff noting that an early refill should not be issued.
On August 5, 2010, R.E.H. made his first visit to Respondent. Tr. 254; GX 8, at 143. According to his medical record, R.E.H.'s chief complaint was back pain. Tr. 256; GX 8, at 143. R.E.H. also reported a history of abusing heroin, which is a “significant addictive illness history,” Tr. 257, as well as tobacco abuse and that he was taking methadone; however, there is no indication that Respondent determined how much methadone R.E.H. was taking, which according to Dr. Mitchell was “a critical bit of information . . . because methadone . . . is approximately five times as potent as morphine.”
Dr. Mitchell further found that Respondent's physical examination was “very cursory for a new patient” as he did not conduct neurological and spinal examinations.
Even though the prescription should have lasted for ten days, R.E.H. returned to Respondent only six days later and obtained a new prescription, which was for 90 tablets of methadone, TID (three times a day).
R.E.H.'s third visit occurred on September 21, 2010. Tr. 262. The progress note documents, however, that R.E.H. was “just release [sic] from jail” and that he had been in jail “15 days.” GX 8, at 141; Tr. 262. The note further states that R.E.H.'s methadone dose was increased to 10 mg five times a day for two weeks, suggesting that this had occurred when he was in jail.
Respondent issued R.E.H. a prescription for 90 pills of methadone 10, TID.
R.E.H. returned to Respondent on November 1, 2010. GX 8, at 139. While R.E.H. was 11 days early, Respondent issued him another prescription for 90 tablets of methadone 10 with the same dosing instruction. GX 8, at 139; Tr. 266. While R.E.H. was not early at his next visit (November 30), when he again obtained a prescription for 90 methadone 10 (one tablet TID, or three times per day), he returned to Respondent on December 23, and obtained a new prescription, which he increased to 120 tablets (TID) even though he was a week early. Tr. 266-67; GX 8, at 137-38; GX 15, at 15-16. According to Dr. Mitchell, none of the prescriptions Respondent issued in November-December 2010 were issued in the usual course of professional practice. Tr. 268. However, Respondent did not require that R.E.H. sign a pain contract until apparently December 23, 2010.
R.E.H. returned on January 4, 2011. GX 8, at 136; GX 15, at 17. Even though R.E.H. was 18 days early, and notwithstanding that the pain contract required him to use his “medicine at a rate no greater than the prescribed rate” and stated that if he used it at a greater rate, he would be “without medication for a period of time,” GX 8, at 242; Respondent issued him another prescription for 90 tablets of methadone 10 with a dosing instruction of TID and PRN (take as needed). GX 8, at 136; GX 15, at 17. Dr. Mitchell testified that this prescription was not issued in the usual course of professional practice and that the usual course of professional practice would be to discharge a patient seeking a prescription two weeks early. Tr. 269. He also testified that it is not in the usual course of medical practice to prescribe methadone with a dosing instruction of PRN because the drug “has [a] very long half-life” and “takes a while . . . to enter the blood” stream, and the reason the drug is used for pain is to provide “a stable blood level” of medication.
Respondent did not, however, discharge R.E.H., who returned on January 26, 2011. GX 8, at 135. Notwithstanding that R.E.H. was eight days early, Respondent issued him a new prescription and increased the quantity to 120 pills and the dosing to four tablets per day. GX 15, at 19-20. Dr. Mitchell testified that this prescription was also not issued within the usual course of medical practice. Tr. 270.
An entry in R.E.H.'s medical record documents that on February 15, 2011, a pharmacy called and reported that R.E.H. had tried to fill three prescriptions for 120 tablets of methadone in less than one month. GX 8, at 18. The note documented that on January 26, 2011, R.E.H. had filled one such prescription at a different pharmacy using insurance, and that on February 1, 2011, he had filled the second prescription at a second pharmacy paying cash.
Dr. Mitchell testified that “this is obviously very concerning behavior” and that a doctor acting the usual course of medical practice would summon the patient and ask for an explanation. Tr. 276-77. He further testified that it would “[a]bsolutely not” be within the usual course of professional practice to issue a new prescription for a controlled substance in these circumstances.
R.E.H.'s file includes a MAPS report which was obtained on the morning of February 17, 2011, two days after the Respondent's office was notified that R.E.H. had filled two prescriptions since January 26 and had attempted to fill a third. GX 8, 236. The MAPS report corroborated the pharmacy's report and showed that R.E.H. had managed to fill Respondent's January 26 prescription on both that date and on February 1, 2011 at two different pharmacies.
While R.E.H. saw Respondent on both February 17 and 22, 2011, there is no evidence that Respondent even addressed R.E.H.'s drug-seeking behavior, let alone discharged him.
Dr. Mitchell testified that there was no justification in R.E.H.'s chart for Respondent's issuance of prescriptions, which authorized the dispensing of a three-month supply of the drug. Tr. 283. He also testified that these prescriptions were not issued in the usual course of professional practice.
The evidence further shows that on June 2, 2011,
R.E.H.'s patient file also includes copies of two prescriptions for 120 Vicodin ES (QID), which were dated November 17 and 22, 2011. GX 8, at 191-92. The document bearing the November 17 prescription includes the notation: “Please verify—just filled this RX on 11/17 for 30 day supply—then the follow[ing] RX was brought in 11/23/11.”
Dr. Mitchell testified that “as a stand-alone incident it's very concerning” because “[i]t smacks of prescription forgery.” Tr. 288. However, in R.E.H.'s case, it was “just another incident . . . in his history that just masked a horrible addictive illness, diversion or both.”
R.E.H.'s patient file also includes a MAPS report which Respondent obtained on December 9, 2011. GX 8, at 185-90. The report showed that during the months of October and November 2011, R.E.H. had filled six prescriptions for 120 methadone 10 (with four of the prescriptions having been filled between Nov. 10 and 29) and that R.E.H. had used four different pharmacies.
Dr. Mitchell testified that the report would indicate “[g]reat concern for what's going on” to a doctor acting in the usual course of medical practice as it showed that R.E.H. was “[o]btaining hundreds of tablets of methadone.” Tr. 291. The report also showed that R.E.H. had obtained other controlled substances (alprazolam and hydrocodone) from two additional pharmacies during these two months. GX 8, at 185-86. Thus, R.E.H. had used a total of six pharmacies.
The evidence also showed that Respondent was prescribing methadone and other controlled substances (alprazolam and hydrocodone) to R.S.H., who was R.E.H.'s wife, and that he obtained a MAPS report on her only minutes after obtaining the MAPS report on R.E.H. GX 13, at 161-68. The MAPS report showed that between October 11, 2011 and November 28, 2011, R.S.H. filled seven prescriptions for 120 methadone 10, four prescriptions for 90 alprazolam (in either .5 or 1 mg dose), and prescriptions for 90 and 120 hydrocodone 7.5.
Regarding this information, Dr. Mitchell testified that “the concerns speak[ ] for itself [sic]. There's something very troublesome and potentially life threatening going on here with multitudes of refills, repeated incidents,” given “there's some indication that they're cohabiting together and have the same last name.” Tr. 294-95. Dr. Mitchell then testified that it was not within the usual course of professional practice to continue writing methadone and other controlled substance prescriptions given these circumstances.
Moreover, on February 29, 2012, Respondent's office received a phone call from a pharmacy, which reported that R.E.H. was using his father's birthdate to fill the prescriptions. GX 8, at 43. The pharmacy also reported that it had called R.E.H.'s father who stated that “he doesn't receive [sic] this script.”
On July 12, 2012 (in the interim, Respondent had continued issuing prescriptions for 120 methadone 10 to R.E.H., several of which were early
The evidence further shows that even when Respondent's nurse noted in R.E.H.'s file that R.E.H. was seeking an early refill, Respondent nonetheless issued a post-dated prescription to him. As found above, the evidence shows that on October 8, 2012, Respondent
On December 12, 2012, R.E.H. was admitted to a hospital after he overdosed on Seroquel. GX 8, at 158. While in the hospital, R.E.H. provided a urine drug test which was positive for cocaine.
Dr. Mitchell testified that upon learning that R.E.H. was using cocaine, the appropriate response was to refer him to inpatient drug rehabilitation as R.E.H. “obviously” had “a life threatening illness manifested by his addicting behavior” as well as to cease prescribing controlled substances to him. Tr. 303. Asked by the Government whether there ever was a point at which Respondent should have stopped writing controlled substance prescriptions to R.E.H., Dr. Mitchell testified:
The short answer is yes. But the whole format of the care is so appalling that he never had a drug contract in the beginning and it's just one infraction after another.
So if you had started from the very beginning, the patient already told you that he has a history of heroin abuse. So if you were to make the decision to treat his . . . back pain . . . there has to be documentation.
Discussing with the patient about concerns regarding his illness, contract agreed upon and . . . random urine samples as well as MAPS surveys being pulled.
In my opinion, in this case, after the second early refill, he'd be discharged from the practice. With the option to go to rehabilitation.
You can't just let him go off and not have some kind of aftercare. I mean—he's a very sick individual . . . regarding his addictive illness.
Following Dr. Mitchell's testimony, Respondent testified on his own behalf. After acknowledging that he had listened to all of Dr. Mitchell's testimony, Respondent was asked by his counsel if Dr. Mitchell is “right or wrong about you ignoring the red flags about patients who are or could be abusing or diverting drugs?” Tr. 484. Respondent answered: “He's right.”
I find (as did the ALJ) that Dr. Mitchell provided credible testimony that Respondent ignored multiple red flags that R.E.H. was abusing and diverting controlled substances and that Respondent lacked a legitimate medical purpose and acted outside of the usual course of professional practice when he continued to prescribe methadone and other drugs in the face of the red flags. While this alone constitutes substantial evidence to support a finding that Respondent violated 21 CFR 1306.04(a) and 21 U.S.C. 841(a)(1) in prescribing to J.E.H., this conclusion is buttressed by Respondent's testimony that Dr. Mitchell was “right” when he testified that Respondent ignored multiple red flags.
The Show Cause Order alleged that from December 23, 2010 through January 4, 2012, Respondent “repeatedly prescribed controlled substances after [he] came to know that J.W. was engaged in the abuse and/or diversion of controlled substances.” ALJ Ex. 1, at 3. Specifically, the Show Cause Order alleged that Respondent repeatedly prescribed controlled substances to J.W. notwithstanding numerous red flags of diversion and/or abuse.
• J.W. repeatedly sought early refills;
• the Michigan Medicaid program notified Respondent that J.W. was doctor-shopping;
• a pharmacy also notified Respondent that J.W. was doctor-shopping;
• J.W. was incarcerated;
• J.W. exhibited withdrawal symptoms; and
• a MAPS report obtained by Respondent in October of 2011 showed that J.W. was engaged in a persistent pattern of doctor and pharmacy shopping.
The Show Cause Order also alleged that J.W.'s patient file and the prescriptions issued to him show that Respondent:
• Prescribed Adderall, a schedule II stimulant, to J.W. on his first visit without diagnosing him with Attention Deficit Disorder (ADD), and that he prescribed other controlled substances without taking actions typical of medical professionals such as conducting and documenting a complete medical history and physical examination, or creating a written treatment plan;
• prescribed numerous controlled substances to J.W. without conducting a MAPS search “that a typical Michigan doctor would have conducted,” and that such a search would have shown that J.W. was engaged in “a dangerous pattern of doctor and pharmacy shopping (through which J.W. obtained 11 monthly prescriptions for Adderall within the first six months of 2011)”;
• prescribed methadone to J.W. with a PRN (take as needed) dosing instruction “within a week of meeting him and repeatedly thereafter”;
• “never subjected J.W. to any drug tests”; and
• “took no action to enforce the pain management contract that J.W. signed on his first visit, in which [J.W.] committed (among other things) to obtain controlled medications from only one provider (Respondent), fill them at one pharmacy, and take them at the prescribed dosages.”
J.W. first saw Respondent on December 23, 2010. GX 9, at 42.
Dr. Mitchell testified that neither prescription was issued in the usual course of professional practice. Tr. 308. As for the Adderall prescription, Dr. Mitchell explained that the drug is “typically” prescribed to treat ADD (Attention Deficit Disorder) or ADHD (Attention Deficit Hyperactivity Disorder).
Dr. Mitchell testified that it was inappropriate for Respondent to issue the methadone prescription at J.W.'s second visit.
There's no documentation that the patient is having any findings based on physical examination that would serve as a foundation for prescribing [me]thadone. Even though the records are reviewed, I don't see any documentation where it states the patient had previously taken [m]ethadone or was on any analgesics whatsoever.
And then there's some notation that's very hard to make out, it says something Vicodin. I can't really read it, but it's in the middle of the HPI box.
I'm not really sure what it's trying to communicate. Whether it's regarding prior Vicodin prescription or what. So it's really not legible.
J.W.'s file includes a fax of a “Notice of Prior Authorization Determination,” which Respondent received from the Michigan Medicaid program on or about January 21, 2011. GX 9, at 69. The form noted that a prior authorization request had been received and provided the name of another physician (Dr. M.) who had prescribed Adderall to J.W.; it also listed a pharmacy other than the one which J.W. had listed on the Pain Management Agreement he entered into at his first visit with Respondent.
Dr. Mitchell further explained that upon learning that J.W. was obtaining Adderall from another doctor, Respondent should have engaged J.W. and obtained an explanation for why he was obtaining prescriptions from two different doctors and documented the encounter. Tr. 313. Respondent, however, did not do this.
On February 16, 2011 (22 days later), J.W. again saw Respondent. GX 9, at 38. Respondent wrote J.W. a new prescription for 60 Adderall even though he was eight days early. Tr. 315. Respondent also wrote J.W. a prescription for 120 methadone 10. GX 16, at 11.
However, only two days later (Feb. 18), Respondent's office received a phone call from a pharmacy reporting that insurance would not cover J.W.'s methadone prescriptions and that he was seeing Dr. M. who was prescribing Suboxone to him—Dr. M. being the same doctor listed as the medical provider on the prior authorization request form Respondent had received from the Michigan Medicaid program.
Dr. Mitchell testified that in response to this information, the appropriate course would be to discharge the patient and recommend that he go to inpatient drug rehabilitation.
On both March 16 and April 6, 2011, Respondent wrote J.W. additional prescriptions for 60 Adderall. GX 16, at 21-22;
The evidence also shows that in the first six months of 2011, Respondent wrote J.W. six prescriptions for 60 Adderall.
The evidence further shows that Respondent issued to J.W. prescriptions for 60 Adderall 30 (BID) and 120 Klonopin (QID) on both July 6 and 26. GX 16, at 41-52. According to Dr. Mitchell, both of the July 26 prescriptions were “approximately a week early” (actually, they were 10 days early), and there was no justification in the patient file for issuing the prescription when Respondent did. Tr. 318.
On October 25, 2011, Respondent received a fax from the Medical Department of the Lapeer County Jail. The fax stated that J.W. was an inmate and requested information as to his prescriptions and diagnosis. GX 9, at 47. Respondent reported that J.W. was on methadone for chronic pain and Adderall for EDS and ADD.
The same day, Respondent obtained a MAPS report on J.W. GX 9, at 48-51; 79-83. The report showed that J.W. was still obtaining controlled substance prescriptions for Suboxone and Adderall from Dr. M., while also
J.W. did not see Respondent again until December 21, 2011. GX 9, at 25. Regarding the progress note for the visit, Dr. Mitchell testified that “the physical exam is really nothing, it says awake and stable.” Tr. 324. As for J.W.'s chief complaint, Dr. Mitchell testified that Respondent's writing was illegible.
J.W. returned on January 4, 2012. On the progress note, Respondent lined through a box next to the words stating “substance abuse +, reviewed w/patie[nt].” GX 9, at 24. However, the progress note is otherwise illegible.
On January 19, 2012, J.W. made his final visit to Respondent and obtained a prescription for 120 tablets of methadone 10 with a dosing instruction of QID and PRN. Tr. 325; GX 16, at 59-60. Asked whether the prescription was issued in the usual course of professional practice, Dr. Mitchell answered “no.” Tr. 325. Asked “why not,” Dr. Mitchell explained: “[w]ell again, the same basis. Where is the justification, based on the patient['s] clinical complaints, a detailed examination, a clear diagnosis that [m]ethadone was justified.”
Again, it would be early on with the early refills. The behavior that is an obvious flag by the patient for addiction illness. Which he has a history of. History of drug abuse is documented in the chart.
As found above, Respondent testified that he had listened to all of Dr. Mitchell's testimony. Respondent was then asked by his counsel if Dr. Mitchell is “right or wrong about you ignoring the red flags about patients who are or could be abusing or diverting drugs?” Tr. 484. Respondent answered: “He's right.”
Based on Dr. Mitchell's credible testimony, I find that the controlled substance prescriptions Respondent provided to J.W. lacked a legitimate medical purpose and were issued outside of the usual course of professional practice and violated the CSA. 21 CFR 1306.04(a); 21 U.S.C. 841(a)(1). This finding is buttressed by Respondent's admission that Dr. Mitchell was correct in his criticism that he ignored red flags.
The Show Cause Order alleged that from January 27, 2011 through July 17, 2012, Respondent repeatedly prescribed controlled substances to R.K. after Respondent knew that R.K. was engaged in the abuse and/or diversion of controlled substances. ALJ Ex. 1, at 4. The Show Cause Order specifically alleged that Respondent repeatedly prescribed to R.K. controlled substances despite the numerous red flags of diversion and/or abuse R.K. presented.
• R.K. repeatedly sought early refills;
• Respondent was notified by the Michigan Department of Community Health Drug Utilization Review that R.K. was doctor shopping;
• a pharmacist contacted [his] office reporting suspicious conduct by R.K.; and
• two consecutive drug tests on April 10, 2012 and May 8, 2012 showed that R.K. was not taking the methadone that Respondent had prescribed to him.
The Show Cause Order also alleged that R.K.'s patient file and the prescriptions issued to him show that Respondent:
• Prescribed controlled substances to R.K. on his first visit without taking actions typical of medical professionals, such as conducting and documenting a complete medical history and physical examination, or creating a written treatment plan;
• never required R.K. to sign a pain management contract or ran a MAPS report on him;
• engaged in a pattern of issuing Xanax prescriptions to R.K. on a near monthly basis that authorized multiple refills, and that while the dosing instructions directed R.K.
• issued a prescription for Xanax to be refilled six times, in violation of state and federal law; and
• stopped testing R.K. to determine if he was taking the methadone Respondent prescribed after R.K. tested negative on two consecutive monthly drug tests.
At the beginning of the Government's examination of Dr. Mitchell about Respondent's prescribing to R.K., the ALJ raised his “concern about evidence that becomes cumulative at some point in a preceding [sic].”
So far I've heard more than one instance. In fact, multiple instances of prescribing [m]ethadone on a PRN basis, which the witness has told me is inconsistent with medical practice.
Not having a complete medical history, not having a physical examination noted in the file, not writing a treatment plan, diagnosing controlled substances without sufficient support in the medical record through objected[sic] testing, imagining [sic] or other data, prescribing controlled substances prematurely before the expiration of the prior prescription, concurrent prescriptions from more than one prescribing source, filling those prescriptions in more than one pharmacy, failure to properly utilize the MAPS data in the record, failure to discharge and failure to enforce the pain medication treatment plan and contract.
Contrary to the ALJ's understanding, the Government was entitled to put on evidence regarding each and every allegation it had raised in the Order to Show Cause and its pre-hearing statements. That the Government had previously shown that Respondent failed to obtain a complete history and conduct an adequate physical exam, or that he failed to address red flags such as repeated early refill requests or ignored evidence of doctor shopping and the use of multiple pharmacies, etc., with respect to patients R.E.H. and J.W., does not render evidence as to whether he acted in the same manner with respect to the other three patients redundant. Furthermore, notwithstanding that evidence of a single act of diversion can, in appropriate circumstances, support an order of revocation, it is for the Government to decide, in the exercise of its prosecutorial discretion, on the number of patients (and prescriptions) that are necessary to prove its case.
On October 20, 2011, Respondent issued R.K. a prescription for 60 tablets of Xanax .5 mg, with a dosing instruction of BID or PRN. ALJ Ex. 50, at 3; Tr. 330. The prescription authorized three refills, ALJ Ex. 50, at 3; and based on the dosing instruction, the prescription provided R.K. with a four-month supply of the drug. However, Dr. Mitchell testified that there was nothing in the progress note for this visit which justified providing R.K. with a four-month supply of the drug. Tr. 330.
Yet, not even six weeks later on November 29, 2011, Respondent issued R.K. an additional prescription for 60 Xanax .5 mg (BID or PRN), with three refills. ALJ Ex. 50, at 3; Tr. 330. Here again, Dr. Mitchell testified that there was no medical justification in the visit's progress note for providing R.K. with another four-month supply of Xanax. Tr. 330-31.
On January 17, 2012, Respondent provided R.K. with another prescription for 60 Xanax (BID and PRN), with three refills. ALJ Ex. 50, at 3. Moreover, Respondent increased the strength of the drug to 1 mg.
On April 10, 2012, Respondent provided R.K. with another prescription for Xanax 1, increasing the quantity to 90 tablets and the dosing to TID (and PRN).
Notwithstanding the numerous refills R.K. had remaining on both the February 15 and April 10 prescriptions (not to mention the supply R.K. had likely obtained from the earlier prescriptions), Respondent provided him with new prescriptions for 90 Xanax 1 (TID or PRN) on May 8 and May 30, 2012. ALJ Ex. 50, at 4. While these two prescriptions did not authorize any refills, on June 21, 2012, Respondent provided R.K. with another prescription for 90 Xanax 1(TID or PRN), which authorized three refills.
According to Dr. Mitchell, from October 20, 2011 through July 17, 2012, R.K. “obtained 1950 tablets of alprazolam,” an amount far in excess (by more than 1,000 pills) of what was necessary based on Respondent's dosing instructions.
The Government also questioned Dr. Mitchell about Respondent's prescribing of methadone to R.K. On March 13, 2012, Respondent first prescribed 90 methadone 5 mg (TID + PRN), a 30-day supply, to R.K. GX 17, at 45-46. However, on April 10, 2012, R.K. tested negative for methadone. GX 10, at 31. A note in the entry states: “ran out week ago.”
Regarding this incident, Dr. Mitchell testified that “[i]f a patient was truly taking [m]ethadone . . . and they abruptly ran out, they would go through significant medical withdrawal.” Tr. 333. Dr. Mitchell further explained that a physician “would engage the patient, are you taking, what's the problem here? Find out why the chaotic pattern in your lab results, when you are prescribing the medication for them and give them a chance to respond.”
At the April 10 visit, Respondent issued R.K. a new prescription for 90 methadone 10 mg (TID), which was double the strength of what he had previously prescribed. GX 17, at 47-48. Moreover, while Respondent subjected R.K. to another drug test during his next visit (May 8, 2012), R.K. again tested negative for methadone claiming that he had run out several days earlier.
Dr. Mitchell testified that “[t]here is no legitimate foundation for” the prescription. Tr. 335. And when asked what the appropriate response was to R.K.'s having provided a second negative urine test for methadone, Dr. Mitchell answered: “[d]ischarge.”
On May 30, 2012, R.K. again saw Respondent, who provided him with a new prescription for 90 methadone 10. GX 10, at 6, 43; GX 17, at 55-56. Notwithstanding that R.K. had provided negative urine samples on his two previous visits, there is no evidence that Respondent required R.K. to provide a new urine sample. Tr. 335. And while Respondent put a slash mark through the box next to the entry “Substance Abuse +, reviewed w/patient,” GX 10, at 43; as Dr. Mitchell explained: “There's no detail, it's just merely a swipe of the pen.” Tr. 336. Continuing, Dr. Mitchell noted that there is “[n]o documentation of, I discussed with the patient two negative urines samples, so forth and so . . . my plan was so forth and so on.”
Asked by the Government whether there was ever a point when Respondent should have discharged R.K., Dr. Mitchell answered “[y]es.”
During cross examination, Dr. Mitchell agreed that by referring R.K. to a physical therapist to treat the patient's back pain, Respondent was employing a multifaceted treatment plan.
Based on the above, I find that all of the controlled substance prescriptions issued by Respondent to R.K. on and after October 20, 2011 lacked a legitimate medical purpose and were issued outside of the usual course of professional practice. 21 CFR 1306.04(a).
The Show Cause Order alleged that from March 10, 2011 through November 30, 2011, Respondent repeatedly prescribed controlled substances to R.J.H. after he knew that R.J.H. was engaged in the abuse and/or diversion of controlled substances.
• R.J.H. repeatedly sought early refills;
• R.J.H. repeatedly reported lost or stolen prescriptions;
• another patient reported that R.J.H. was selling his prescription of methadone and taking his girlfriend's prescription as his own; and
• R.J.H. was requesting controlled substances by name.
The Government also alleged that R.J.H.'s patient file and the prescriptions issued to him show that Respondent:
• Prescribed controlled substances to R.J.H. on his initial visit without taking actions typical of medical professionals such as conducting and documenting a complete medical history and physical examination, requiring that R.J.H. (a self-identified addict) sign a pain management contract or submit to a drug test, running a MAPS search on R.J.H., and creating a written treatment plan, which was periodically re-evaluated;
• never subjected R.J.H. to drug tests;
• never ran a MAPS report on R.J.H.;
• never required R.J.H. to sign a pain management agreement; and
• repeatedly prescribed methadone to R.J.H. to be taken “PRN.”
The Government's presentation with respect to R.J.H. focused primarily on the manner in which Respondent escalated the amount of methadone he prescribed and ignored various red flags. R.J.H. first saw Respondent on March 10, 2011, at which time Respondent documented that R.J.H. had a history of narcotic abuse. GX 11, at 3, 57;
Dr. Mitchell testified that this was “a significant escalation in” the total “24 hour dose” of R.J.H.'s methadone regimen. Tr. 338. Dr. Mitchell further explained there was “no” justification for Respondent's having quadrupled R.J.H.'s daily dose.
Progress notes in R.J.H.'s file show that R.J.H. had appointments with Respondent on both May 18 and May 26, 2011. GX 11, at 52-53. Moreover, on May 17, 2011, Respondent wrote R.J.H. a new prescription for 120 tablets of methadone 10 QID and PRN), and on May 26, 2011, he wrote R.J.H. another prescription for 120 tablets of methadone 10 (QID and PRN). GX 18, at 15-16, 19-20. Attempting to interpret Respondent's handwriting on the May 26 progress note, Dr. Mitchell thought that R.J.H had reported “that the prescription was stolen,” Tr. 339, and according to a notation on the May 26 prescription, R.J.H. told the pharmacist that “he was beat[en] up and his meds were stolen.” GX 18, at 20. A further notation on the prescription states: “Early refill Ok'd by Dr. Ataya Police Report on file. Per Christina @Dr. Ataya's.”
Dr. Mitchell testified that when a patient claims that his medication has been stolen, “there needs to be some action on the patient['s]” part. Tr. 339. According Dr. Mitchell, “part of the opioid contract [is] that if medications are stolen, you have to make a police report.”
On June 8, R.J.H. again saw Respondent. GX 11, at 51. A nurse's note on the progress note states: “meds (stolen).”
The evidence also shows that on June 7, 2011, an employee of Respondent documented that he/she “was told by another patient that [R.J.H.] was selling his prescription of methadone, and taking his girlfriend[']s prescription as his own.” GX 11, at 9. While Respondent did not prescribe methadone to R.J.H. at the June 8 visit,
While this prescription should have lasted R.J.H. for 30 days, only six days later on June 21, 2011, Respondent issued to R.J.H. a prescription for 60 tablets of methadone 10, thereby doubling the daily dose.
Moreover, Respondent continued to provide R.J.H. with additional early refills. Specifically, only 15 days later on July 6, Respondent issued to R.J.H. a prescription for 60 methadone 10 (BID/PRN).
Only 13 days later on July 19, 2011, Respondent issued to R.J.H. a prescription for 120 of methadone 10 (QID, or four times a day), thereby doubling the daily dose and quantity.
As Dr. Mitchell testified, there was no justification for Respondent's rapid escalation of R.J.H.'s daily dose. Also, Respondent ignored red flags such as R.J.H.'s claim on two occasions that his prescription had been stolen, the report that he was selling his methadone and using his girlfriend's, and R.J.H.'s repeated seeking of early refills, some of which were weeks early. Moreover, while Respondent knew that R.J.H. had a history of narcotic abuse he did not require him to sign a pain contract, never conducted a drug test on him, and never obtained a MAPS report. Based on the above, I find that Respondent lacked a legitimate medical purpose and acted outside of the usual course of professional practice when prescribed methadone to R.J.H. 21 CFR 1306.04(a).
The Show Cause Order alleged that from June 10, 2010 through August 12, 2012, Respondent repeatedly prescribed controlled substances to J.H. even after he knew that she was engaged in the
• J.H. repeatedly sought early refills;
• J.H. requested controlled medications by name;
• J.H. was in frequent contact with Respondent's office regarding her pain medications;
• J.H. tested negative for controlled substances that Respondent had prescribed to her;
• Respondent diagnosed J.H. as narcotic dependent;
• hospital records in Respondent's file show that J.H. tested positive for illegal drugs; and
• J.H. exhibited symptoms of withdrawal.
The Show Cause Order also alleged that J.H.'s patient files and the prescriptions Respondent issued to her show that he:
• Issued controlled substance prescriptions to J.H. on her initial visit without taking actions typical of medical professionals such as conducting and documenting a complete medical history and physical examination, and creating a written treatment plan;
• diagnosed J.H. as being narcotic dependent but took no actions such as referring her to rehabilitation or a specialist, or even minimal precautionary steps such as requiring her to sign a pain management contract, subjecting her to comprehensive drug tests, or even running MAPS reports on her, and that MAPS reports would have shown that she was engaged in doctor and pharmacy shopping;
• prescribed two different benzodiazepines—Klonopin and Xanax—to J.H. even after she reported that she would not be using Xanax but using Klonopin instead;
• repeatedly prescribed methadone to J.H. to be taken “PRN”; and
• prescribed Adderall to J.H. without any basis for doing so, continued to prescribe Adderall after drug tests showed that she was not taking the drug, stopped conducting drug tests to determine if J.H. was taking the Adderall he prescribed, and only stopped prescribing the drug when the Michigan Medicaid program asked him to substantiate his prescriptions.
The progress note for J.H.'s November 10, 2010 visit shows that on that date, Respondent diagnosed J.H. as “narcotic dependent.” GX 12, at 125; Tr. 343. While Dr. Mitchell stated that he did not know if Respondent was “trying to indicate a history of abuse by that statement or he wasn't familiar with the definitions of addiction versus dependence,” he explained that the decision to start a patient on methadone “depends on the history you gleaned from the patient and what the old medical records showed,” because “you're essentially becoming their addictionologist and beginning treatment for them.”
There is, however, no evidence that Respondent required J.H. to enter an opioid agreement. Tr. 347;
Of note, the Government also submitted a MAPS report it obtained showing J.H.'s prescriptions from January 8, 2010 through February 2013. However, the questioning regarding the MAPS reports was interrupted by telephonic interference seven times and is not clear what the precise questions were and which of the MAPS reports the Government was referring to in its questions. Tr. 348-49.
The evidence shows that on November 26, 2010, Respondent issued to J.H. a prescription for 90 methadone 5 (TID), a 30-day supply. GX 19, at 21-22. Yet, according to J.H.'s file, on December 1, 2010, she was suffering from narcotic withdrawal. Tr. 349. Dr. Mitchell testified that when confronted with this situation, the appropriate response of a physician acting within the bounds of professional practice is to send the patient “to the hospital.”
The evidence further shows that on September 8, 2010, J.H. called Respondent's office “and stated that she stopped Xanax
However, on December 1, 2010, he issued J.H. a prescription for 60 alprazolam 1.
During 2012, Respondent issued J.H. a prescription for 90 clonazepam on Jan. 5, with three refills that were filled on Feb. 1, Feb. 19, and Mar. 10; a prescription for 90 clonazepam on Mar. 28; a prescription for 120 clonazepam on April 25, with three refills, two of which were filled on May 15 and June 6; a second prescription for 120 clonazepam on April 25, which was filled on July 4; and two prescriptions for 90 clonazepam on August 14, one of which was filled the same date, the other being filled on December 8.
The evidence also shows that on August 3, 2011, Respondent issued J.H.
Dr. Mitchell testified that J.H.'s clean urine tests raised the same concerns (
Finally, the Government questioned Dr. Mitchell as to whether there was a point at which Respondent should have stopped prescribing controlled substances to J.H.
Notwithstanding that no weight can be given to Dr. Mitchell's testimony regarding the October 11, 2011 drug tests, I find that the evidence otherwise supports a finding that Respondent provided J.H. with controlled substance prescriptions which lacked a legitimate medical purpose and were issued outside of the usual course of professional practice. 21 CFR 1306.04(a). As the evidence shows, while Respondent knew that J.H. was dependent on narcotics, he: (1) Did not require her to sign an opioid agreement; (2) did not obtain a MAPS report on her until two years after he determined that she was dependent; (3) conducted only three drug tests over the course of the 26 months that he prescribed to her; (4), did not refer her to treatment when she was suffering from withdrawal even though he had given her a 30-day methadone prescription only five days earlier and continued to prescribe methadone to her; and (5) repeatedly prescribed both alprazolam and clonazepam to her, even after she had told him that she did not like the way the Xanax (alprazolam) made her feel.
Concluding its direct examination, the Government asked Dr. Mitchell: “Of the prescriptions that we have discussed today, are there any that you've found to be legitimate, issued for [a] legitimate purpose or within the usual practice of medicine?” Tr. 356. Dr. Mitchell answered: “Not for the controlled substances.”
Respondent testified on his own behalf. According to Respondent, he graduated from medical school in Damascus, Syria in 1993, and after moving to the United States, he did an internal medicine residency which he completed in 2002. Tr. 469. Thereafter, Respondent started practicing at nursing homes and assisted living facilities and also worked as an urgent care and ER physician.
According to Respondent, when he started his internal medicine practice, he “did not expect this influx of chronic pain patient[s], and . . . was not planning to have a clinic for chronic pain patients.”
As found above, Respondent acknowledged that he had “listened to all of” Dr. Mitchell's testimony.
Respondent further testified that he had reviewed multiple online Continuing Medical Education courses,
Respondent further asserted that “[s]ince the interview on the show cause, it came to [his] attention some wrong way in doing and dealing with patients” and he “went back and review[ed] what he's been doing and inquire[d].”
On cross-examination, Respondent further asserted that after being served with the Show Cause Order, he started doing more frequent drug screening “to identify any problematic patients.”
Asked whether, in the period 2010-2012, he believed that doctors should not prescribe controlled substances to patients who are abusing or diverting them, Respondent testified: “If it is a proof they are abusing or diverting, yes.”
Well, counseling the patient in the room and talking to them about their pain and their using their pain medication and the way, and what is their answer, for me I will take whatever the patient tell me.
If they said no, they are not abusing the medication, they are not diverting the medication, and I am entitled to treat their symptoms and make sure they are not going in withdrawal and take care of the patient.
The Government then asked Respondent whether he “believe[s] that doctors should detect when patients are abusing or diverting controlled substances?”
Next, the Government asked Respondent: “[w]hat are the signs for abuse and diversion of controlled substances?”
The Government then asked Respondent what signs he looks for to see if a patient is abusing medication.
Well, if they're using, now a patient if he is taking the pain medication and they have extra pain and taking medication, extra pill or extra two, this is a view that what you intend that it is abusing, well, it's still a pain medication they are using to control their symptoms. I don't understand what exactly what answer you want for that.
I'm telling you exactly what I think. If the patient using the pain medication instructed to control their pain medication, now if they come earlier to take medication that's if they have a chronic problem and they need it, somebody can call them abusing, some people calling them they are controlling their pain symptoms.
After again admitting that he “did not pay attention too much to this [sic] signs with the red flags and things,”
After confirming that Respondent was adhering to his earlier testimony that Dr. Mitchell was correct that he had ignored red flags of abuse and diversion, the Government asked Respondent whether he also agreed with Dr. Mitchell's testimony that he had “issued prescriptions outside of the usual course of practice or for nonlegitimate medical purposes?”
Notably, in his Post-Hearing Brief, Respondent states that Dr. Mitchell's testimony establishes that he “wrote a substantial number of prescriptions . . . without a legitimate medical purpose and/or in the usual course of a practitioner's professional practice and/or in the face of paradigmatic `red flags' of diversion or abuse such as repeated requests for early refills, facially-evident documentation of doctor shopping, and testing results inconsistent with use of the prescribed controlled substances.” Resp. Post-Hrng Br. at 12.
As noted above, both parties filed exceptions to the ALJ's Recommended Decision. Having reviewed their briefs, I conclude that some of their exceptions are best addressed prior to discussing whether the Government is entitled to prevail under the public interest standard. These include Respondent's contention that the ALJ committed prejudicial error when he barred him from cross-examining the Diversion Investigator regarding the use of confidential informants.
As found above, at the hearing, a DEA Diversion Investigator testified regarding the investigation she
In response to the objection, Respondent argued that the Agency “is required to consider not just the evidence that [the Government] brought in on the direct, but evidence that we can bring out on cross examination.”
The ALJ sustained the objection, on the ground that Respondent had failed to disclose in advance of the hearing that he “wanted to cover this subject.”
Respondent then argued that his counsel had not had “the time that the Government had to prepare” for the hearing and that there was no prejudice to the Government, because “these are their witnesses.”
Even assuming that the Government's direct examination of the DI as to what steps she took in investigating Respondent opened the door to this line of inquiry, the ALJ did not abuse his discretion in sustaining the Government's objection.
To be sure, DEA has recognized that in some instances, evidence of “prior good acts” can refute evidence that a registrant knowingly or intentionally diverted controlled substances.
In his Exceptions, Respondent further notes that the ALJ “frames this issue as one `regarding arguably exculpatory evidence that has been withheld by the Government.' ” Exceptions, at 9 (citing R.D. at 60-62). He then states that he adopts and incorporates by reference the ALJ's view, and requests that I consider it as a separate argument.
Therein, the ALJ noted that the Agency has not adopted “[t]he rule from
Unacknowledged by the ALJ is that several federal appeals courts have held that
Instead, this Agency follows the holding of
Section 304(a) of the Controlled Substances Act (CSA) provides that a registration to “dispense a controlled substance . . . may be suspended or revoked by the Attorney General upon a finding that the registrant . . .
(1) The recommendation of the appropriate State licensing board or professional disciplinary authority.
(2) The applicant's experience in dispensing . . . controlled substances.
(3) The applicant's conviction record under Federal or State laws relating to the manufacture, distribution, or dispensing of controlled substances.
(4) Compliance with applicable State, Federal, or local laws relating to controlled substances.
(5) Such other conduct which may threaten the public health and safety.
“[T]hese factors are . . . considered in the disjunctive.”
The Government has the burden of proving, by a preponderance of the evidence, that the requirements for revocation or suspension pursuant to 21 U.S.C. 824(a) are met. 21 CFR 1301.44(e). However, “once the [G]overnment establishes a prima facie case showing a practitioner has committed acts which render his registration inconsistent with the public interest, the burden shifts to the practitioner to show why his continued registration would be consistent with the public interest.”
In this matter, the Government's evidence focused on factors two, four, and five. Having reviewed the record in its entirety and having considered all of the factors, I find that the Government's evidence with respect to factors two and four satisfies its
Under a longstanding DEA regulation, a prescription for a controlled substance is not “effective” unless it is “issued for a legitimate medical purpose by an individual practitioner acting in the usual course of his professional practice.” 21 CFR 1306.04(a). Continuing, the regulation provides that “an order purporting to be a prescription issued not in the usual course of professional treatment . . . is not a prescription within the meaning and intent of [21 U.S.C. 829] and . . . the person issuing it, shall be subject to the penalties provided for violations of the provisions of law relating to controlled substances.”
As the Supreme Court has explained, “the prescription requirement . . . ensures patients use controlled substances under the supervision of a doctor so as to prevent addiction and recreational abuse. As a corollary, [it] also bars doctors from peddling to patients who crave the drugs for those prohibited uses.”
Both this Agency and the federal courts have held that establishing a violation of the prescription requirement “requires proof that the practitioner's conduct went `beyond the bounds of any legitimate medical practice, including that which would constitute civil negligence.' ”
Thus, in
The evidence presented at trial was sufficient for the jury to find that respondent's conduct exceeded the bounds of “professional practice.” As detailed above, he gave inadequate physical examinations or none at all. He ignored the results of the tests
Under the CSA, it is fundamental that a practitioner must establish a bona fide doctor-patient relationship in order to act “in the usual course of . . . professional practice” and to issue a prescription for a “legitimate medical purpose.”
However, while the Government frequently relies on a physician's failure to establish a bona-fide doctor-patient relationship to prove a violation of 21 CFR 1306.04(a), no “specific set of facts ha[s] to be present in order to find that a physician stepped outside of his role and issued prescriptions without a legitimate medical purpose.”
As found above, Dr. Mitchell offered extensive and uncontested testimony that included identifying specific acts and omissions by Respondent, which support the conclusion that Respondent acted outside of the usual course of professional practice and without a legitimate medical purpose when he prescribed controlled substances to each of the five patients. He also opined that none of the prescriptions he discussed complied with 21 CFR 1306.04(a). Tr. 356.
In his post-hearing brief, Respondent states that Dr. Mitchell's testimony establishes that he “wrote a substantial number of prescriptions . . . without a legitimate medical purpose and/or in the usual course of a practitioner's professional practice and/or in the face of paradigmatic `red flags' of diversion or abuse such as repeated requests for early refills, facially-evident documentation of doctor shopping, and testing results inconsistent with use of the prescribed controlled substances.” Resp. Proposed Recommended Rulings, Findings of Fact and Conclusions of Law, at 12. Respondent, however, also attempts to portray himself as a soft touch, suggesting that it is “culturally ingrained” that he could “not say no” to patients, and that he prescribed “with some naivety and perhaps even full-blown gullibility,” which was “laid bare when the size of his practice grew exponentially faster than he and his staff” were capable of managing. Respondent's Post-Hrng. Submission, at 1-2.
The ALJ embraced this argument.
Contrary to the ALJ's understanding, the Government was not required to prove that Respondent was motivated by avarice or greed to establish a violation of 21 CFR 1306.04(a) and 21 U.S.C. 841(a)(1). Nor did the ALJ reconcile the inconsistency between his findings that that Respondent violated 21 CFR 1306.04(a) with respect to each of the patients—findings which establish that he knowingly diverted drugs—with his embrace of Respondent's claim that he was merely naïve and gullible. Indeed, Respondent offered no testimony to support the claims made in his brief that he prescribed out of naivety or gullibility, or that his inability to say no was “culturally ingrained.”
As for the ALJ's embrace of Respondent's claim that he was not running a pill mill and was treating his patients, to be sure, there is some evidence that Respondent referred patients for MRIs, a sleep study, and alternative treatments such a chiropractor and physical therapy. However, the overwhelming weight of the evidence shows that Respondent issued the prescriptions knowing that the patients were either abusing or diverting the drugs.
With respect to R.E.H., Dr. Mitchell found Respondent's initial evaluation to be inadequate based on Respondent's failure to adequately develop his substance abuse history and how much methadone he was currently taking. He further found that Respondent did not perform an adequate physical examination. He therefore concluded that Respondent acted outside of the usual course of professional practice in issuing the initial methadone prescriptions. Based on this testimony, I find that Respondent did not establish a bona fide doctor-patient relationship and I further conclude that at no point in the course of his treatment of R.E.H. did Respondent do so.
Dr. Mitchell further described a plethora of instances in which Respondent provided R.E.H. with early refills and failed to document that he had engaged R.E.H. as to why he needed the early refills. Dr. Mitchell pointed out that Respondent failed to enforce his medication contract which required R.E.H. to use his medicine only at the prescribed rate. He also pointed out that Respondent continued to prescribe without obtaining urine samples, and only rarely obtained a MAPS report. Moreover, even when he did obtain and review a MAPS report, the MAPS report showed that R.E.H. had filled the same prescriptions at different pharmacies, and yet Respondent failed to even address R.E.H.'s behavior and continued to prescribe methadone to him. So too, Respondent was notified on multiple occasions that R.E.H. was trying to fill multiple prescriptions and presenting forged prescriptions, and yet did nothing to address this obvious drug-seeking behavior and continued to prescribe to him. Finally, even after he received a report that R.E.H. had tested positive for cocaine and was diagnosed as polysubstance dependent, he continued to prescribe to R.E.H. In short, given the numerous times that R.E.H. sought early refills, coupled with the information Respondent obtained from MAPS reports, pharmacies and the hospital, Respondent cannot credibly
The same holds true with respect to Respondent's prescribings to J.W. Here too, Dr. Mitchell testified that there was no clinical basis to diagnose J.W. with a condition that would support prescribing both Adderall and methadone. He also testified that it was inappropriate to prescribe methadone on a PRN basis. Moreover, Respondent ignored evidence that J.W. was obtaining Adderall from another physician, in violation of the medication contract, as well as that J.W. was obtaining Suboxone from the other physician. J.W. also sought early refills on multiple occasions, yet Respondent continued to prescribe to him.
Also, the same day that Respondent was informed that J.W. was in the county jail, Respondent obtained a MAPS report which showed that J.W. had continued to obtain controlled substances for Suboxone and Adderall from another doctor at the same time he was obtaining prescriptions from Respondent. Moreover, Respondent was notified by J.W.'s niece that her uncle was selling his medications. Yet notwithstanding this information, after J.W. was released from jail, Respondent eventually resumed prescribing controlled substances to him. Here again, the evidence amply refutes the contention that Respondent was merely gullible or naïve.
With respect to R.K., the evidence showed that Respondent issued multiple prescriptions for Xanax, which frequently authorized multiple refills, resulting in R.K. obtaining, in a nine-month period, approximately 1,000 pills more than were necessary based on Respondent's dosing instructions. Given that R.K.'s chart contained copies of the prescriptions, Respondent cannot credibly argue that he was duped by R.K. into issuing the excessive prescriptions. Also, while Respondent prescribed methadone to R.K., on two occasions, R.K. tested negative for the drug, stating after the first test that he had run out a week earlier, and after the second, stating that he had run out several days earlier. Yet there was no documentation that R.K. had undergone withdrawal, this being a clear indication that R.K. was diverting the drug. Respondent continued to prescribe the drug to R.K. (going so far as to double the strength after the first negative test) and did not subject him to any more drug tests after the second test. The evidence thus shows that Respondent was willfully blind to what R.K. was doing with the drugs. Moreover, Dr. Mitchell testified that there was no medical evidence to support the methadone prescriptions. Here again, the evidence amply refutes the contention that Respondent issued the prescriptions because he was gullible or naïve.
Respondent knew that R.J.H. had a history of drug abuse. Yet over the course of just six weeks, Respondent quadrupled R.J.H.'s daily dosage of methadone with no medical justification. Moreover, within three months of R.J.H.'s seeing Respondent, R.J.H. had twice claimed that his prescriptions were stolen, and the day before the second such incident, Respondent's office had been told by another patient that R.J.H. was selling his prescription and using his girlfriend's medication. Yet Respondent issued him another prescription and continued to prescribe methadone to him, even though R.J.H. sought early refills. Here again, the evidence refutes Respondent's contention that he issued the prescriptions because he was gullible or naïve.
So too, the evidence with respect to J.H. refutes Respondent's claim that he was gullible or naïve. Here the evidence shows that only five days after Respondent issued her a prescription for a 30-day supply of methadone, she was suffering from narcotic withdrawal. Yet, instead of sending her for treatment, Respondent continuing prescribing controlled substances to her. Moreover, over the course of his treatment of J.H., on multiple occasions, Respondent prescribed either alprazolam or clonazepam to her, both being benzodiazepines, even though he had recently prescribed the other drug to her. Also, even after J.H. reported that she did not like how alprazolam made her feel, he still issued her more prescriptions for the drug. So too, even after J.H. tested negative for Adderall, he issued her a new prescription for the drug. Finally, over the course of the 26 months Respondent treated her, he only drug tested her three times, with all three tests occurring in a three-month period. I thus conclude that Respondent knew or was willfully blind to the fact that J.H. was either abusing or diverting her drugs to others.
In addition to his issuance of numerous unlawful prescriptions, Respondent also violated federal law by writing a methadone prescription for R.E.H. which he dated as having been issued on November 8, 2012, when he likely issued it on October 30, 2012. Notably, the evidence shows that on October 8, 2012, Respondent issued R.E.H. a methadone prescription, which R.E.H. filled the same day. GX 15, at 135-36. The evidence also shows that on October 30, R.E.H. was seeking more methadone and his medical record states that it was not time yet and includes a copy of a prescription bearing an issue date of November 8, 2012. GX 8, at 15;
Under a DEA regulation, “[a]ll prescriptions for controlled substances shall be dated as of, and signed on, the day when issued.” 21 CFR 1306.05(a). Based on Respondent's failure to address the DI's testimony regarding this prescription and there being no evidence that R.E.H. saw Respondent on November 8, 2012, I find that Respondent violated this regulation when he post-dated the prescription.
The evidence also shows that Respondent repeatedly failed to include the patients' addresses on their prescriptions.
Finally, the evidence shows that on several occasions, Respondent issued prescriptions that authorized six refills. GX 8, at 23 (Xanax Rx issued to R.E.H.); GX 17, at 49 (Xanax Rx issued to R.K.); GX 19, at 117 (Klonopin Rx issued to J.H.). Respondent violated DEA regulations when he issued the prescriptions because, with respect to schedule III and IV controlled substances, a prescription may not “refilled more than five times.” 21 CFR 1306.22(a).
Accordingly, I find that the Government's evidence with respect to Factors Two and Four conclusively establishes that Respondent has committed such acts as to render his registrations “inconsistent with the public interest.” 21 U.S.C. 824(a)(4);
Moreover, while the Government put on no evidence as to Factor One—the recommendation of the state licensing board—in response to my November 10, 2015 order, the Parties have acknowledged that on October 30, 2015, the Michigan Board of Medicine revoked Respondent's medical license and that he is longer legally authorized to dispense controlled substances in the State in which he is registered and seeks additional registrations.
Under Agency precedent, where, as here, “the Government has proved that a registrant has committed acts inconsistent with the public interest, a registrant must “ `present sufficient mitigating evidence to assure the Administrator that [he] can be entrusted with the responsibility carried by such a registration.” ' ”
The Agency has also held that “ `[n]either
The ALJ found that Respondent “failed to take the full and unconditional acceptance of responsibility required by” the Agency's case law. R.D. at 55. As support for this conclusion, the ALJ noted that during his cross-examination of Dr. Mitchell, Respondent “challenged multiple aspects of the Government's evidence regarding [his] treatment of the patients that were fundamental to the Government's case against him.”
Respondent takes exception to the ALJ's finding that he did not accept responsibility for his misconduct. Resp. Exceptions, at 2-9. He argues that the ALJ misapplied Agency precedent, “in effect penaliz[ing] him for his failure to immediately confess wrongdoing in response to naked allegations.”
While I find some of Respondent's arguments well taken, I reject his exception. As for the ALJ's pre-hearing ruling barring Respondent from eliciting the testimony of Ms. Richards, (who would have testified regarding a risk assessment audit and the training she provided to Respondent's staff), in his Recommended Decision, the ALJ asserted that he would have allowed Ms. Richards to testify if Respondent had “informed the Government in its prehearing statements that he acknowledged the noncompliance of his prescription practice.” R.D. at 60. However, while not mentioned in the Recommended Decision, the ALJ granted the Government's motion based also on Respondent's failure to describe Ms. Richard's testimony “with sufficient particularity.” Tr. 39 (Nov. 3, 2014). This was an independent and adequate ground to bar her testimony, and yet, Respondent does not challenge the ALJ's ruling on this basis.
Had the ALJ's ruling barring Ms. Richard's testimony been based solely on Respondent's failure to state in his pre-hearing statements that he was acknowledging his misconduct, I would agree with Respondent. Contrary to the ALJ's understanding, although the Agency has held that proof of remedial measures is rendered irrelevant where a respondent fails to accept responsibility
Notwithstanding that the Government provided, in its prehearing statements, notice of the evidence it intended to rely on in supporting the allegations of the Show Cause Order, Respondent was entitled to challenge the reliability of that evidence at the hearing and to show that the allegations were untrue. However, I decline to decide the question of whether it was consistent with principles of due process to require Respondent, as a condition of being able to subsequently present evidence of his remedial measures, to admit to his misconduct before it had even been proven on the record.
I respectfully disagree with the ALJ's assertion that the Agency “is holding registrants to an unfair standard.” On the contrary, given the harm to public safety caused by the diversion of controlled substances, the Agency's policy of requiring those respondents, who have been shown to have engaged in knowing or intentional misconduct to acknowledge their misconduct, is fully within the Agency's discretion.
When faced with evidence that a doctor has a history of distributing controlled substances unlawfully, it is reasonable for the . . . Administrator to consider whether that doctor will change his or her behavior in the future. And that consideration is vital to whether [his] continued registration is in the public interest. Without Dr. MacKay's testimony, the . . . Administrator had no evidence that Dr. MacKay recognized the extent of his misconduct and was prepared to remedy his prescribing practices.
664 F.3d at 820. Absent evidence that a registrant acknowledges his misconduct in intentionally or knowingly diverting controlled substances, there is no basis to conclude that the registrant is prepared to remedy his prescribing practices and allowing the registrant to maintain his registration “is inconsistent with the public interest.” 21 U.S.C. 824(a)(4). As for the ALJ's further contention that there is “more to determining what constitute the public interest than this one criterion,” R.D. 58, the Agency considers other factors including the egregiousness of the proven misconduct. Thus, in cases of less egregious misconduct, the Agency has frequently imposed sanctions less than a denial or revocation notwithstanding that a respondent failed to fully acknowledge his misconduct. However, the intentional or knowing diversion of controlled substances strikes at the CSA's core purpose of preventing drug abuse and diversion.
As for the ALJ's reliance on
Of further note, while both physicians sought judicial review of the respective agency decision, in each case, the Court of Appeals denied their petitions in an unpublished decision.
Nor was Respondent the only party displeased with the ALJ's ruling on the issue of the adequacy of his acceptance of responsibility. Indeed, the Government argues that the ALJ obstructed its cross-examination of Respondent on this very issue. Gov. Exceptions, at 9-18. The Government sets forth various instances in which the ALJ precluded it from conducting a meaningful inquiry into the sincerity of Respondent's acceptance of responsibility and the scope of his present understanding of lawfully appropriate prescribing practices.
The Government further points to various incongruities in the ALJ's decision, including his conclusion that Respondent “ `failed to take the full and unconditional acceptance of responsibility,' ” while later in the same paragraph, finding that Respondent “ `unequivocally stated that he did not dispute the evidence brought against him.' ” Gov. Exceptions, at 12 (quoting R.D. 55). To similar effect, the Government argues that notwithstanding the various instances in which the ALJ cut off its cross-examination of Respondent, the ALJ later explained that he could not evaluate Respondent's contention that he should be able to continue to prescribe controlled substances subject to various restrictions, “ `without first providing the Government a full and fair opportunity to first thoroughly test the depth of [Respondent's] acknowledgment of noncompliance.' ” Gov. Exceptions, at 12 (quoting R.D. 63).
The Government also argues that “[t]he ALJ's decisions make it difficult for the Administrator to know if Respondent would have `acknowledg[ed] that his conduct violated the law' at hearing.” Gov.
I conclude, however, that a remand is unwarranted for multiple reasons. As explained above,
Here, the evidence shows that Respondent is an egregious violator of the CSA in that he ignored countless red flags presented by the patients that they were either abusing or diverting (or both) the controlled substances he prescribed for them. And with respect to Patients J.H. and R.E.H., the evidence shows that this went on for several years. Given the egregiousness of his misconduct, the Agency's interest in protecting the public by both preventing him from being able to dispense controlled substances as well as by deterring misconduct by others is substantial. I thus conclude that continuing Respondent's existing registrations and granting his applications for the additional registrations would be “inconsistent with the public interest.” 21 U.S.C. 823(f), 824(a)(4).
There is further reason to conclude that a remand is unwarranted. As found above, the State of Michigan has now revoked Respondent's medical license, thus rendering him without authority to dispense controlled substances in the State in which he holds his registrations and seeks the additional registrations. Thus, Respondent no longer meets the CSA's prerequisite for obtaining and maintaining a registration.
Thus, pursuant to 21 U.S.C. 824(a)(3), the Attorney General is also authorized to suspend or revoke a registration issued under section 823, “upon a finding that the registrant . . . has had his State license or registration suspended [or] revoked . . . by competent State authority and is no longer authorized by State law to engage in the . . . dispensing of controlled substances.” Because Congress has clearly mandated that a practitioner possess state authority in order to be deemed a practitioner under the Act, DEA has long held that the revocation of a practitioner's registration is the appropriate sanction whenever he is no longer authorized to dispense controlled substances under the laws of the State in which he practices medicine.
The Government nonetheless argues that because this issue was “never raised in the Order to Show Cause,” a decision on this ground “could arguably upend basic protections afforded to DEA registrants and would surely diminish the perceived fairness of the . . . administrative process.” Govt's Resp. to Admin. Order, at 11. The Government acknowledges that it “is certainly empowered to issue an Order to Show Cause (or an Amended Order to Show Cause) alleging this factual basis and legal ground for revocation or denial” and to submit evidence.
For his part, Respondent does not dispute that the Michigan Board has revoked his medical license and that he “no longer has any legal authority to dispense controlled substances.” Respondent's Resp. to Admin. Order, at 1. However, he then states that as a procedural matter, he agrees with the Government that “simply skipping ahead to a 21 U.S.C. 824(a)(3) revocation that the parties never litigated would likely be inconsistent with due process.”
I reject both parties' contention that I cannot rely on Respondent's loss of his state authority absent the Government's submission of an amended show cause order. Because the possession of state authority is a prerequisite for obtaining a registration and for maintaining a registration, the issue can be raised
Notably, the Government's position is fundamentally inconsistent with the position it has taken in numerous cases where it has issued an Order to Show Cause based on public interest grounds only to subsequently move for summary disposition upon learning that the
Here, by virtue of my order directing the parties to address the issues of: (1) Whether Respondent currently possesses authority to dispense controlled substances, and (2) if Respondent does not possess such authority, what consequence attaches for this proceeding, Respondent was provided with a meaningful opportunity to show that he retains his state authority. Of consequence, Respondent does not dispute that he no longer holds authority to dispense controlled substances under Michigan law, this being the only material fact that must be adjudicated in determining whether Respondent's registrations can be revoked and his applications denied under 21 U.S.C. 823(f) and 824(a)(3) as well as the Agency's precedent. That there are no dispositive legal arguments to preclude my reliance on this basis as an additional ground to revoke Respondent's registrations and to deny his applications is not the result of constitutionally inadequate notice. Rather, it is the result of the statute itself, which makes the possession of state authority mandatory for obtaining and maintaining a registration and renders irrelevant the issues of acceptance of responsibility and the adequacy of remedial measures. Accordingly, I will order that Respondent's registrations be revoked and that his pending applications be denied.
Pursuant to the authority vested in me by 21 U.S.C. 824(a) and 28 CFR 0.100(b), I order that DEA Certificates of Registration BA7776353 and FA2278201 issued to Hatem M. Ataya, M.D., be, and they hereby are, revoked. Pursuant to the authority vested in me by 21 U.S.C. 823(f) and 28 CFR 0.100(b), I order that all pending applications submitted by Hatem M. Ataya, M.D. be, and they hereby are, denied. This Order is effective immediately.
Notice of registration.
Mallinckrodt, LLC applied to be registered as a manufacturer of certain basic classes of controlled substances. The Drug Enforcement Administration (DEA) grants Mallinckrodt, LLC registration as a manufacturer of those controlled substances.
By notice dated September 16, 2015, and published in the
The DEA has considered the factors in 21 U.S.C. 823(a) and determined that the registration of Mallinckrodt, LLC to manufacture the basic classes of controlled substances is consistent with the public interest and with United States obligations under international treaties, conventions, or protocols in effect on May 1, 1971. The DEA investigated the company's maintenance of effective controls against diversion by inspecting and testing the company's physical security systems, verifying the company's compliance with state and local laws, and reviewing the company's background and history.
Therefore, pursuant to 21 U.S.C. 823(a), and in accordance with 21 CFR 1301.33, the above-named company is granted registration as a bulk manufacturer of the following basic classes of controlled substances:
The company plans to manufacturer bulk active pharmaceutical ingredients (API) for distribution to its customers.
Notice of application.
Registered bulk manufacturers of the affected basic class, and applicants therefore, may file written comments on or objections to the issuance of the proposed registration in accordance with 21 CFR 1301.33(a) on or before April 18, 2016.
Written comments should be sent to: Drug Enforcement Administration, Attention: DEA Federal Register Representative/ODW, 8701 Morrissette Drive, Springfield, Virginia 22152.
The Attorney General has delegated her authority under the Controlled Substances Act to the Administrator of the Drug Enforcement Administration (DEA), 28 CFR 0.100(b). Authority to exercise all necessary functions with respect to the promulgation and implementation of 21 CFR part 1301, incident to the registration of manufacturers, distributors, dispensers, importers, and exporters of controlled substances (other than final orders in connection with suspension, denial, or revocation of registration) has been redelegated to the Deputy Assistant Administrator of the DEA Office of Diversion Control (“Deputy Assistant Administrator”) pursuant to section 7 of 28 CFR part 0, appendix to subpart R.
In accordance with 21 CFR 1301.33(a), this is notice that on November 4, 2015, Cedarburg Pharmaceuticals, Inc., 870 Badger Circle, Grafton, Wisconsin 53024 applied to be registered as a bulk manufacturer of nabilone (7379), a basic class of controlled substance listed in schedule II.
The company plans to manufacturer bulk active pharmaceutical ingredients (API) for distribution to its customers.
Notice of registration.
Euticals, Inc. applied to be registered as a manufacturer of certain basic classes of controlled substances. The Drug Enforcement Administration (DEA) grants Euticals, Inc. registration as a manufacturer of those controlled substances.
By notice dated September 16, 2015, and published in the
The DEA has considered the factors in 21 U.S.C. 823(a) and determined that the registration of Euticals, Inc. to manufacture the basic classes of controlled substances is consistent with the public interest and with United States obligations under international treaties, conventions, or protocols in effect on May 1, 1971. The DEA investigated the company's maintenance of effective controls against diversion by inspecting and testing the company's physical security systems, verifying the company's compliance with state and local laws, and reviewing the company's background and history.
Therefore, pursuant to 21 U.S.C. 823(a), and in accordance with 21 CFR 1301.33, the above-named company is granted registration as a bulk manufacturer of the following basic classes of controlled substances:
The company plans to manufacture the listed controlled substances in bulk for distribution and sale to its customers.
In reference to oripavine (9330), the company plans to acquire the listed controlled substance in bulk from a domestic source in order to manufacture other controlled substances in bulk for distribution to its customers.
Notice of registration.
Catalent Pharma Solutions, LLC applied to be registered as an importer of a certain basic class of controlled substance. The Drug Enforcement Administration (DEA) grants Catalent Pharma Solutions, LLC registration as an importer of this controlled substance.
By notice dated August 21, 2015, and published in the
The DEA has considered the factors in 21 U.S.C. 823, 952(a) and 958(a) and determined that the registration of Catalent Pharma Solutions, LLC to import the basic class of controlled substance is consistent with the public interest and with United States obligations under international treaties, conventions, or protocols in effect on May 1, 1971. The DEA investigated the company's maintenance of effective controls against diversion by inspecting and testing the company's physical security systems, verifying the company's compliance with state and local laws, and reviewing the company's background and history.
Therefore, pursuant to 21 U.S.C. 952(a) and 958(a), and in accordance with 21 CFR 1301.34, the above-named company is granted registration as an importer of hydromorphone (9150), a basic class of controlled substance listed in schedule II.
The company plans to import the above listed controlled substance for a clinical trial study. Approval of permit applications will occur only when the
Notice of registration.
Sigma Aldrich International GMBH-Sigma Aldrich Co. LLC applied to be registered as an importer of a basic class of controlled substance. The Drug Enforcement Administration (DEA) grants Sigma Aldrich International GMBH-Sigma Aldrich Co. LLC registration as an importer of this controlled substance.
By notice dated October 13, 2015, and published in the
The DEA has considered the factors in 21 U.S.C. 823, 952(a) and 958(a) and determined that the registration of Sigma Aldrich International GMBH-Sigma Aldrich Co. LLC, to import the basic class of controlled substance is consistent with the public interest and with United States obligations under international treaties, conventions, or protocols in effect on May 1, 1971. The DEA investigated the company's maintenance of effective controls against diversion by inspecting and testing the company's physical security systems, verifying the company's compliance with state and local laws, and reviewing the company's background and history.
Therefore, pursuant to 21 U.S.C. 952(a) and 958(a), and in accordance with 21 CFR 1301.34, the above-named company is granted registration as an importer of butylone (7541), a basic class of controlled substance listed in schedule I.
The company plans to import the above listed controlled substance for analytical research and testing of equipment. This authorization does not extend to the import of a finished FDA approved or non-approved dosage form for commercial sale.
On October 16, 2014, the Deputy Assistant Administrator, Office of Diversion Control, issued an Order to Show Cause to Arvinder Singh, M.D. (Respondent), of Clifton Park, New York. ALJ Ex. 1. The Show Cause Order proposed the denial of Respondent's application for a DEA Certificate of Registration as a practitioner on three grounds.
First, the Show Cause Order alleged that on August 4, 2003, Respondent, following a jury trial, was convicted on 16 counts of health care fraud in violation of 18 U.S.C. 1347, one count of conspiracy to distribute controlled substances in violation of 21 U.S.C. 846, and 24 counts of unlawful distribution of controlled substances in violations of 21 U.S.C. 841(a)(1) and 18 U.S.C. 2.
Second, the Show Cause Order alleged that Respondent's convictions for violating the Controlled Substances Act “were based on a scheme in which [he] left pre-signed but otherwise blank prescriptions for [his] nursing staff to fill in and issue Schedule II controlled substances prescriptions to patients when neither [he] nor any other physician saw the patient at the time such prescriptions were issued.”
Third, the Show Cause Order alleged that on May 8, 2004, the U.S. Department of Health and Human Services (HHS) excluded Respondent from participation in federal health care programs for a period of 15 years based on his convictions for Health Care Fraud and for violating the Controlled Substances Act.
Following service of the Show Cause Order, Respondent requested a hearing on the allegations. The matter was placed on the docket of the Office of Administrative Law Judges and assigned to Chief Administrative Law Judge (hereinafter, CALJ) John J. Mulrooney, II. Following pre-hearing procedures, the CALJ conducted a hearing at which both parties introduced documentary evidence and called witnesses to testify. Thereafter, both parties submitted briefs containing their proposed findings of fact, conclusions of law, and arguments regarding the ultimate disposition of this matter.
On February 10, 2015, the CALJ issued his Recommended Decision. Therein, the CALJ found that the Government had established a
(1) The recommendation of the appropriate State licensing board or professional disciplinary authority.
(2) The applicant's experience in dispensing . . . controlled substances.
(3) The applicant's conviction record under Federal or State laws relating to the manufacture, distribution, or dispensing of controlled substances.
(4) Compliance with applicable State, Federal, or local laws relating to controlled substances.
(5) Such other conduct which may threaten the public health and safety.
“These factors are . . . considered in the disjunctive.”
These included that Respondent had been convicted of twenty-four counts of
In addition to the above, the evidence also shows that Respondent “has been excluded . . . from participation in” federal health care programs pursuant to the mandatory exclusion provisions of 42 U.S.C. 1320a-7(a).
Turning to whether Respondent had produced sufficient evidence to rebut the Government's
The CALJ also found that Respondent's misconduct was egregious and “militates persuasively in favor of denial of his application.”
However, the CALJ then found that “[t]he issue of specific deterrence . . . is a dramatically different issue.”
Respondent filed Exceptions to the Recommended Decision and the Government filed a response to Respondent's Exceptions. Thereafter, the record was forwarded to my Office for Final Agency Action.
Having considered the record in its entirety (including Respondent's Exceptions), I adopt the CALJ's findings of fact and conclusions of law to the extent they are discussed herein. Because I agree with the CALJ's ultimate findings that: (1) Multiple grounds exist to deny Respondent's application, (2) Respondent has failed to adequately acknowledge his misconduct, (3) Respondent's misconduct was egregious, and (4) the Agency's interest in specific deterrence supports the denial of his application, I will adopt the CALJ's recommendation that I deny Respondent's application. A discussion of Respondent's Exceptions follows.
Invoking
Contrary to Respondent's contention, the Government was not required to show that any of the drugs obtained through these prescriptions were diverted.
Respondent also argues “that billing issues were criminalized through the use of [the] CSA despite no evidence of Diversion or Public Safety Issues.” Exceptions, at 2. However, in affirming his convictions for health care fraud,
Respondent further argues that the CALJ ignored substantial evidence in concluding that he failed to acknowledge his misconduct. Exceptions, at 3. Respondent argues that:
I admitted right from the start in 1999 that I made the mistake of leaving Pre-Signed Prescriptions for legitimate patients of the practice with treatment plan spelled [out] in the chart, and not for Diversion. I never tried to trivialize it. . . . I admitted to the truth. The Agency wants me to admit Diversion (drug trafficking) when there was none.
My review of the record finds no instance of the Agency attempting to elicit from Respondent an admission that he engaged in drug trafficking. What the record does show, however, is that Respondent still fails to acknowledge the risk of diversion created by his practice of providing pre-signed but otherwise blank prescriptions to his nurses and authorizing them to issue the prescriptions to the patients he did not see.
The CALJ then asked: “[s]o there was no safety issue with some patient who you didn't know was going to get the prescription, with whatever drugs that were written on it that you didn't know, . . . there was no way in your view that any of those patients could be harmed?” Tr. 269-70. Respondent answered: “They were following my previous protocol.”
Later, the CALJ asked: “[s]he [the Nurse] was exercising her judgment for patients that you didn't know for medications that you had no idea because you signed them?”
In response, the CALJ stated: “I know those are your words, but they're not very convincing the way that you say it. I must say that your tenor, it's not very convincing that you think that.”
Moreover, at the hearing, Respondent continued to dispute the extent of his misconduct in pre-signing prescriptions. Respondent testified that he engaged in this practice only after November 25, 1997, when another physician suddenly left his practice, and “I left a few, you know, eight or 10 prescriptions pre[-]signed without any patient name.” Tr. 250. The CALJ then asked Respondent: “So your testimony is that there were—in the entire practice that you had there were only eight to 10 times that you pre[-]signed prescriptions?”
The CALJ again asked: “And that's your testimony under oath?”
After Respondent asserted that the difference between pre-signed and pre-filled prescriptions was that the former did not have a patient's name, the CALJ again asked: “So . . . it's your recollection that there were only eight to 10 times that this occurred?”
The evidence further shows that on December 2, 1997, Investigators from the New York State Bureau of Controlled Substances went to his office at Albany Memorial Hospital and found six blank pre-signed prescriptions in the possession of his nurse. RX 12, at 2. At the hearing, Respondent testified that “[a]fter the investigation, we stopped doing that.”
Respondent, however, was convicted of twenty-four counts of causing an act to be done and aiding and abetting the unlawful distribution of schedule II controlled substances based on his having provided pre-signed but otherwise blank prescriptions to his employees.
As for his testimony that he stopped providing pre-signed prescriptions after becoming aware of the investigation, Respondent was convicted of having committed the offense on five occasions in January 1998, more than a month after he became aware of the investigation.
Likewise, with respect to his convictions for health care fraud, Respondent asserted that there were only 15 or 20 times when he billed an office visit as if he had seen the patient when the patient had only been seen by a nurse.
Finally, Respondent argues that the CALJ improperly ignored the State's recommendation; he also provides a laundry list of exhibits that he believes the CALJ ignored. As for the decision of the Peer Committee of the New York State Department of Education Committee in the Professions, the State has not made a recommendation to the Agency as to whether to grant a new registration to Respondent. While the State's decision to issue Respondent a new medical license establishes that he again holds authority under state law to dispense controlled substances and thereby satisfies the CSA's prerequisite for obtaining a practitioner's registration, this “Agency has long held that `the Controlled Substances Act requires that the Administrator . . . make an independent determination [from that made by state officials] as to whether the granting of controlled substance privileges would be in the public interest.' ”
Notably, under New York law, “an applicant . . . does not have to admit past wrongdoing the applicant does not believe he committed . . . in order to be readmitted to his profession.” GX 9F, at 12 (citation omitted). To be sure, in exercising its sovereign power to regulate the medical profession, the State of New York may follow this policy.
Thus, while Respondent has put forward evidence of his remedial measures, his continued refusal to acknowledge the full scope of his criminal conduct precludes a finding that his registration would be consistent with the public interest.
Moreover, as I have previously explained, the record contains no support for Respondent's assertion (Exceptions at 4) that he was required to admit to having issued prescriptions outside of the usual course of professional practice and for other than a legitimate medical purpose (
Accordingly, I find the CALJ's conclusion that Respondent has not accepted responsibility for his misconduct to be fully supported by the record and that he has not put forward sufficient evidence “that could reasonably support a finding that” he can be entrusted with a registration. R.D. at 38. Because I also agree with the CALJ's finding that Respondent's misconduct was egregious and that he still “does not believe he was mistaken in any way,” I also agree that these factors support the denial of his application.
Pursuant to the authority vested in me by 21 U.S.C. 823(f) and 28 CFR 0.100(b), I order that the application of Arvinder Singh, M.D., for a DEA Certificate of Registration as a practitioner, be, and it hereby is, denied. This Order is effective immediately.
Employment and Training Administration, Labor.
Funding Opportunity Announcement (FOA).
The Employment and Training Administration (ETA), U.S. Department of Labor, announces the availability of up to $20,000,000 in grant funds authorized by section 169(c) of the Workforce Innovation and Opportunity Act (WIOA), Public Law 113-128, Dislocated Worker Demonstration Projects, and the Consolidated Appropriation Act of 2016, Public Law 114-113 for the pilot grant program, Summer Jobs and Beyond: Career Pathways for Youth (CPY). ETA plans to award approximately 10-11 grants of approximately $2,000,000 each to Local Workforce Development Boards (LWDB). This program is designed to provide employment-related services to eligible youth who are new entrants to the workforce, including those with limited current or past work experience.
The program will provide youth with work experience opportunities, including summer and year‐round part‐time job opportunities for in-school youth and employment and work experience opportunities throughout the year for out-of-school youth, and exposure to career pathways in in‐demand job sectors. The grants will require partnerships between LWDBs and local summer employment programs, employers, Local Education Agencies (LEAs), and re‐engagement centers. Other community partners may provide services to eligible youth that assist in the development of work experience and entry into career pathways.
The complete FOA and any subsequent FOA amendments in connection with this solicitation are described in further detail on ETA's Web site at
The closing date for receipt of applications under this Announcement is March 25, 2016. We must receive applications no later than 4:00:00 p.m. Eastern Time.
Janice Sheelor, Grants Management Specialist, Office of Grants Management, at (202) 693-3538. Applicants should email all technical questions to
The Grant Officer for this FOA is Latifa Jeter.
Notice.
The Department of Labor (DOL) is submitting the Office of Workers' Compensation Programs (OWCP) sponsored information collection request (ICR) titled, “Representative Fee Request,” to the Office of Management and Budget (OMB) for review and approval for continued use, without change, in accordance with the Paperwork Reduction Act of 1995 (PRA), 44 U.S.C. 3501
The OMB will consider all written comments that agency receives on or before March 21, 2016.
A copy of this ICR with applicable supporting documentation; including a description of the likely respondents, proposed frequency of response, and estimated total burden may be obtained free of charge from the RegInfo.gov Web site at
Submit comments about this request by mail or courier to the Office of Information and Regulatory Affairs, Attn: OMB Desk Officer for DOL-OWCP, Office of Management and Budget, Room 10235, 725 17th Street NW., Washington, DC 20503; by Fax: 202-395-5806 (this is not a toll-free number); or by email:
Michel Smyth by telephone at 202-693-4129, TTY 202-693-8064, (these are not toll-free numbers) or by email at
44 U.S.C. 3507(a)(1)(D).
An attorney or other representative may
This information collection is subject to the PRA. A Federal agency generally cannot conduct or sponsor a collection of information, and the public is generally not required to respond to an information collection, unless it is approved by the OMB under the PRA and displays a currently valid OMB Control Number. In addition, notwithstanding any other provisions of law, no person shall generally be subject to penalty for failing to comply with a collection of information that does not display a valid Control Number.
OMB authorization for an ICR cannot be for more than three (3) years without renewal, and the DOL seeks to extend PRA authorization for this information collection for three (3) more years, without any change to existing requirements. The DOL notes that existing information collection requirements submitted to the OMB receive a month-to-month extension while they undergo review. For additional substantive information about this ICR, see the related notice published in the
Interested parties are encouraged to send comments to the OMB, Office of Information and Regulatory Affairs at the address shown in the
• Evaluate whether the proposed collection of information is necessary for the proper performance of the functions of the agency, including whether the information will have practical utility;
• Evaluate the accuracy of the agency's estimate of the burden of the proposed collection of information, including the validity of the methodology and assumptions used;
• Enhance the quality, utility, and clarity of the information to be collected; and
• Minimize the burden of the collection of information on those who are to respond, including through the use of appropriate automated, electronic, mechanical, or other technological collection techniques or other forms of information technology,
Notice.
The Department of Labor (DOL) is submitting the Office of Workers' Compensation Programs (OWCP) sponsored information collection request (ICR) titled, “Request for Employment Information” to the Office of Management and Budget (OMB) for review and approval for continued use, without change, in accordance with the Paperwork Reduction Act (PRA) of 1995 (44 U.S.C. 3501
The OMB will consider all written comments that agency receives on or before March 21, 2016.
A copy of this ICR with applicable supporting documentation; including a description of the likely respondents, proposed frequency of response, and estimated total burden may be obtained free of charge from the RegInfo.gov Web site at
Submit comments about this request by mail or courier to the Office of Information and Regulatory Affairs, Attn: OMB Desk Officer for DOL-OWCP, Office of Management and Budget, Room 10235, 725 17th Street NW., Washington, DC 20503; by Fax: 202-395-5806 (this is not a toll-free number); or by email:
Michel Smyth by telephone at 202-693-4129, TTY 202-693-8064, (these are not toll-free numbers) or sending an email to
44 U.S.C. 3507(a)(1)(D).
This ICR seeks to extend approval under the PRA for the Request for Employment Information, Form CA-1027, information collection used to collect data about a claimant's private sector employment. The OWCP uses the information to determine continued eligibility for benefits under the Federal Employees' Compensation Act (FECA). FECA section 4(b) authorizes this information collection.
This information collection is subject to the PRA. A Federal agency generally cannot conduct or sponsor a collection of information, and the public is generally not required to respond to an information collection, unless it is approved by the OMB under the PRA and displays a currently valid OMB Control Number. In addition, notwithstanding any other provisions of law, no person shall generally be subject to penalty for failing to comply with a collection of information that does not display a valid Control Number.
OMB authorization for an ICR cannot be for more than three (3) years without renewal, and the DOL seeks to extend PRA authorization for this information collection for three (3) more years, without any change to existing requirements. The DOL notes that existing information collection requirements submitted to the OMB receive a month-to-month extension while they undergo review. For additional substantive information about this ICR, see the related notice published in the
Interested parties are encouraged to send comments to the OMB, Office of Information and Regulatory Affairs at the address shown in the
• Evaluate whether the proposed collection of information is necessary for the proper performance of the functions of the agency, including whether the information will have practical utility;
• Evaluate the accuracy of the agency's estimate of the burden of the proposed collection of information, including the validity of the methodology and assumptions used;
• Enhance the quality, utility, and clarity of the information to be collected; and
• Minimize the burden of the collection of information on those who are to respond, including through the use of appropriate automated, electronic, mechanical, or other technological collection techniques or other forms of information technology,
Occupational Safety and Health Administration (OSHA), Labor.
Notice of MACOSH Membership.
On April 29, 2015, the Secretary of Labor announced the renewal of the Maritime Advisory Committee for Occupational Safety and Health (MACOSH). The MACOSH charter was signed on April 30, 2015, and will expire after two years on April 30, 2017. On January 20, 2016, Secretary Perez selected 15 members and a Special Agency Liaison to serve on the Committee. The Committee is diverse and balanced, both in terms of segments of the maritime industry represented (
MACOSH will contribute to OSHA's performance of its duties under the Occupational Safety and Health Act of 1970 (29 U.S.C. 651
The maritime industry has historically experienced a high incidence of work-related fatalities, injuries, and illnesses. OSHA targeted this industry for special attention due to that experience. This targeting included development of guidance or outreach materials specific to the industry, rulemakings to update requirements, and other activities. MACOSH will advise the Secretary through the Assistant Secretary of Labor for Occupational Safety and Health on matters relevant to the safety and health of employees in the maritime industry. The Committee's advice will result in more effective enforcement, training and outreach programs, and streamlined regulatory efforts.
OSHA received nominations of highly qualified individuals in response to the Agency's request for nominations (80 FR 31620, June 3, 2015). The Secretary selected to serve on the Committee individuals who have broad experience relevant to the issues to be examined by the Committee. The MACOSH members are:
The Special Agency Liaison to MACOSH is:
David Michaels, Ph.D., MPH, Assistant Secretary of Labor for Occupational Safety and Health, U.S. Department of Labor, 200 Constitution Avenue NW., Washington, DC 20210, authorized the preparation of this notice pursuant to Sections 6(b)(1), and 7(b) of the Occupational Safety and Health Act of 1970 (29 U.S.C. 655(b)(1), 656(b)), the Federal Advisory Committee Act (5 U.S.C. App. 2), Section 41 of the Longshore and Harbor Workers' Compensation Act (33 U.S.C. 941), Secretary of Labor's Order 1-2012 (77 FR 3912, Jan. 25, 2012), and 29 CFR part 1912.
The National Science Board's
Wednesday, February 17, 2016 from 8:30 p.m.-9:30 p.m. EST.
Task Force Chair's opening remarks; approval of minutes of the closed January 28, 2016 meeting; Task Force Chair's update; and Discussion.
Closed.
This meeting will be held by teleconference originating at the National Science Board Office, National Science Foundation, 4201 Wilson Blvd., Arlington, VA 22230.
Please refer to the National Science Board Web site (
Nuclear Regulatory Commission.
Regulatory Guide; issuance.
The U.S. Nuclear Regulatory Commission (NRC) is issuing Revision 2 of Regulatory Guide (RG) 1.127, “Criteria and Design Features for Inspection of Water-Control Structures Associated with Nuclear Power Plants.” This RG describes a method that the staff of the NRC considers acceptable for designing water-control structures (
Revision 2 to RG 1.127 is available on February 18, 2016.
Please refer to Docket ID NRC-2011-0011 when contacting the NRC about the availability of information regarding this document. You may obtain publically-available information related to this document using the following methods:
• Federal Rulemaking Web site: Go to
• NRC's Agencywide Documents Access and Management System (ADAMS): You may obtain publicly-available documents online in the ADAMS Public Document collection at
• NRC's PDR: You may examine and purchase copies of public documents at the NRC's PDR, Room O1-F21, One White Flint North, 11555 Rockville Pike, Rockville, Maryland 20852.
Regulatory guides are not copyrighted, and NRC approval is not required to reproduce them.
Robert Pettis, Office of Nuclear Reactor Regulation, telephone: 301-415-3214, email:
The NRC is issuing a revision to an existing guide in the NRC's “Regulatory Guide” series. This series was developed to describe and make available to the public information regarding methods that are acceptable to the NRC staff for implementing specific parts of the agency's regulations, techniques that the NRC staff uses in evaluating specific issues or postulated events, and data that the NRC staff needs in its review of applications for permits and licenses.
Revision 2 of RG 1.127 was issued with a temporary identification as Draft Regulatory Guide, DG-1245. The RG is being updated to provide licensees and applicants with the most current guidance and to help ensure that applicants and licensees are able to demonstrate compliance with the applicable regulations.
DG-1245 was published in the
This RG is a rule as defined in the Congressional Review Act (5 U.S.C. 801-808). However, the Office of Management and Budget has not found it to be a major rule as defined in the Congressional Review Act.
This RG does not constitute backfitting as defined in section 50.109 of title 10 of the
Existing licensees and applicants for standard design certifications will not be required to comply with the new positions set forth in this RG, unless the licensee or standard design certification applicant seeks a voluntary change to its licensing basis with respect to ISI or surveillance programs for water-control structures, and where the NRC determines that the safety review must include consideration of the ISI or surveillance program. Further information on the staff's use of the RG is contained in the RG under Section D. Implementation.
For the Nuclear Regulatory Commission.
The ACRS Subcommittee on Plant License Renewal will hold a meeting on March 2, 2016, Room T-2B1, 11545 Rockville Pike, Rockville, Maryland.
The meeting will be open to public attendance.
The agenda for the subject meeting shall be as follows:
The Subcommittee will review the Fermi Unit 2 License Renewal Application. The Subcommittee will hear presentations by and hold discussions with representatives of the NRC staff, DTE Electric Company, and other interested persons regarding this matter. The Subcommittee will gather information, analyze relevant issues and facts, and formulate proposed positions and actions, as appropriate, for deliberation by the Full Committee.
Members of the public desiring to provide oral statements and/or written comments should notify the Designated Federal Official (DFO), Kent Howard (Telephone 301-415-2989 or Email:
Detailed meeting agendas and meeting transcripts are available on the NRC Web site at
If attending this meeting, please enter through the One White Flint North building, 11555 Rockville Pike, Rockville, MD. After registering with security, please contact Mr. Theron Brown (Telephone 240-888-9835) to be escorted to the meeting room.
The ACRS Subcommittee on Radiation Protection and Nuclear Materials will hold a meeting on March 2, 2016, Room T-2B1, 11545 Rockville Pike, Rockville, Maryland.
The meeting will be open to public attendance.
The agenda for the subject meeting shall be as follows:
The Subcommittee will review draft NUREG/CR-7209, “A Compendium of Spent Fuel Transportation Package Response Analyses to Severe Fire Accident Scenarios.” The Subcommittee will hear presentations by and hold discussions with the NRC staff and other interested persons regarding this matter. The Subcommittee will gather information, analyze relevant issues and facts, and formulate proposed positions and actions, as appropriate, for deliberation by the Full Committee.
Members of the public desiring to provide oral statements and/or written comments should notify the Designated Federal Official (DFO), Christopher Brown (Telephone 301-415-7111 or Email:
Detailed meeting agendas and meeting transcripts are available on the NRC Web site at
If attending this meeting, please enter through the One White Flint North building, 11555 Rockville Pike, Rockville, MD. After registering with security, please contact Mr. Theron Brown (Telephone 240-888-9835) to be escorted to the meeting room.
The ACRS Subcommittee on Reliability and PRA will hold a meeting on March 1, 2016, Room T-2B1, 11545 Rockville Pike, Rockville, Maryland.
The meeting will be open to public attendance with the exception of portions that may be closed to protect information that is proprietary pursuant to 5 U.S.C. 552b(c)(4). The agenda for the subject meeting shall be as follows:
The Subcommittee will discuss the progress of the NRC staff's Level 3 Probabilistic Risk Assessment (PRA) Project. The Subcommittee will hear presentations by and hold discussions with the NRC staff and other interested persons regarding this matter. The Subcommittee will gather information, analyze relevant issues and facts, and formulate proposed positions and actions, as appropriate, for deliberation by the Full Committee.
Members of the public desiring to provide oral statements and/or written comments should notify the Designated Federal Official (DFO), John Lai (Telephone 301-415-5197 or Email:
Detailed meeting agendas and meeting transcripts are available on the NRC Web site at
If attending this meeting, please enter through the One White Flint North building, 11555 Rockville Pike, Rockville, Maryland. After registering with security, please contact Mr. Theron Brown (Telephone 240-888-9835) to be escorted to the meeting room.
Nuclear Regulatory Commission.
License termination; issuance.
The U.S. Nuclear Regulatory Commission (NRC) is providing public notice of the termination of Source Materials License No. STB-401. The NRC has terminated the license of the decommissioned Mallinckrodt facility in St. Louis, Missouri and has approved the site for unrestricted release.
Notice of termination of Source Materials License No. STB-401 issued on February 18, 2016.
Please refer to Docket ID NRC-2016-0032 when contacting the NRC about the availability of information regarding this document. You may obtain publicly-available information related to this document using any of the following methods:
•
•
•
Karen Pinkston, Office of Nuclear Material Safety and Safeguards, U.S. Nuclear Regulatory Commission, Washington DC 20555-0001; telephone: 301-415-3650, email:
The NRC has terminated License No. STB-401, held by Mallinckrodt LLC (Mallinckrodt), for a site in St. Louis, Missouri and has approved the site for unrestricted release.
In 1961, Mallinckrodt received License No. STB-401 to extract columbium and tantalum from natural ores and tin slags. In July 1993, the NRC amended Mallinckrodt's license to a possession only license for the purpose of decommissioning and license termination. The contamination at the site was due to licensed activities consisted of natural uranium, natural thorium, and their associated progeny. The Mallinckrodt site is a 43 acre site subdivided into ten areas called Plants. The former Columbium-Tantalum (C-T) process areas included 21 support buildings on approximately 4.2 acres, primarily located within Plant 5, but also in portions of Plants 1, 3, 6, 7, and 8.
In addition to the C-T activities conducted under License No. STB-401, the Mallinckrodt site was previously used for Manhattan Engineer District/Atomic Energy Commission (MED/AEC) activities. The U.S. Army Corps of Engineers (USACE) is responsible for remediating these portions of the site under the Formerly Utilized Sites Remedial Action Program (FUSRAP).
Mallinckrodt decommissioned the C-T project areas of the site in two phases. In Phase I, Mallinckrodt decommissioned the buildings and equipment to the extent necessary to meet the NRC's guidelines for unrestricted release in § 20.1402 of title 10 of the
Following Phase I decommissioning, the C-T areas remaining for remediation were limited to the soil, pavement, and sewers in Plant 5, as well as portions of Plant 6 and 7. Mallinckrodt's Phase II Decommissioning Plan (DP) (ADAMS Accession Nos. ML083150652 and ML101620140) described Mallinckrodt's plan for decommissioning the remainder of the C-T project areas to meet the criteria for unrestricted release, though the remediation of portions of Plants 6 and 7 was not included in the DP and was addressed separately, as is described below. The NRC approved Mallinckrodt's Phase II DP on July 1, 2010 (ADAMS Accession No. ML091960063).
Plants 6 and 7 contained residual contamination from both licensed activities and MED/AEC activities. The MED/AEC activities in Plants 6 and 7 resulted in contamination in buildings and soil in these plants. Additionally, in Plant 6, approximately 300 cubic yards of unreacted ore (URO) generated as part of the C-T process was buried in 10 trenches in 1972 and 1973. Plant 7 contained sewers, a grit chamber, and two wastewater neutralization basins that were used to support C-T operations.
Mallinckrodt and the USACE entered into two agreements to delineate remediation responsibilities in Plants 6 and 7. Mallinckrodt's responsibilities included the removal of the buried URO in Plant 6 and the removal of the grit chamber in Plant 7. On February 9, 2015, USACE provided Mallinckrodt with a letter acknowledging that Mallinckrodt had completed the removal of the URO and grit chambers and stating that the USACE was proceeding with remediation of these areas under FUSRAP (ADAMS Accession No. ML15090A705).
Mallinckrodt's Phase II DP requested that the NRC terminate its license in accordance with 10 CFR 20.1402 without accounting for MED/AEC contamination in demonstrating compliance with the dose limits in § 20.1402. In its approval of the Phase II DP, the NRC exempted the MED/AEC material from consideration in demonstrating compliance with license termination requirements (ADAMS Accession No. ML091960087). The basis for granting the exemption was: (1) Mallinckrodt will meet 25 mrem/year unrestricted release criteria for C-T process areas; and (2) unlicensed MED/AEC material is being remediated to the NRC's unrestricted release standards of 25 mrem/year by USACE. The dose from the residual radioactivity at the site is primarily from the direct radiation pathway, therefore the NRC concluded that an individual would not simultaneously receive a dose from both areas. The staff, therefore, concluded that it is reasonable to terminate License STB-401 after Mallinckrodt completes decommissioning activities in the C-T process areas and demonstrates that the C-T process areas at the site meet the NRC's unrestricted release criteria.
This finding is based in part on USACE's commitment to remediate the site under FUSRAP. At the time, Mallinckrodt and USACE had reached an agreement regarding delineation of responsibility for remediating Plant 6, but had not yet agreed on the delineation of responsibility for Plant 7. Therefore, the exemption was conditioned on Mallinckrodt and USACE reaching a delineation agreement for Plant 7 before decommissioning was complete. Mallinckrodt and USACE entered into a delineation agreement for Plant 7 on October 31, 2014 (cover letter available at ADAMS Accession No. ML15041A076).
Mallinckrodt performed remediation of the C-T project areas based on their Phase II DP, conducted a Final Status Survey (FSS) and provided the NRC with a Final Status Survey Report (FSSR) documenting the residual radioactivity remaining on site for which Mallinckrodt was responsible (ADAMS Accession No. ML14177A180). Mallinckrodt subsequently provided additional information in response to the NRC's requests for additional information (ADAMS Accession Nos. ML14339A278, ML15177A051, and ML15334A417). On February 12, 2015, Mallinckrodt submitted a license amendment application requesting the use of the dose assessment approach, as well as the derived concentration guideline level (DCGL) approach (ADAMS Accession No. ML15063A404). The NRC approved this license amendment request on February 4, 2016 (ADAMS Accession No. ML15286A174).
The NRC has now completed its review of the FSSR and associated documents according to NUREG-1757, “Consolidated Decommissioning Guidance,” and guidance in the Multi-Agency Radiation Survey and Site Investigation Manual (MARSSIM) (NUREG 1575). The NRC staff has concluded that the FSS design and data collected were adequate to characterize the residual radioactivity in the portions of the Mallinckrodt site where NRC regulated activities took place. The NRC staff also concluded that the data analysis and dose assessments performed are appropriate and that the projected dose from residual radioactivity in these areas is less than the 25 mrem/year dose criterion in 10 CFR 20.1402. For these reasons, the NRC staff has determined that Mallinckrodt has demonstrated that the site will meets the radiological criteria for license termination described in 10 CFR part 20 subpart E and the exemption granted by the NRC in its approval of the Phase II DP. Therefore, Source Materials License No. STB-401 has been terminated.
For the Nuclear Regulatory Commission.
Before the Board is a petition to intervene and request for a hearing, filed by Blue Ridge Environmental Defense League and its chapter Concerned Citizens of Shell Bluff (collectively Petitioner).
On or before Friday, March 11, 2016, the Petitioner, the Licensee, and the NRC Staff must each provide the names of their representatives by email to the Board and the service list. Only designated representatives will be permitted to present oral argument. Each counsel or other representative for each participant in this proceeding who has not already done so must file and serve a notice of appearance on or before March 11, 2016, containing all of the information required by 10 CFR § 2.314(b).
The primary purpose of this oral argument is for the Board to ask questions and receive answers concerning contention admissibility issues presented by the pleadings. As to each contention, the Petitioner shall have 15 minutes to present an introductory argument, and the NRC Staff and the Licensee shall each have 10 minutes as well. The Petitioner may reserve up to 5 minutes of its allotted time for rebuttal. No other rebuttal will be permitted.
In general, the participants should not repeat arguments already presented in their written filings, but should focus on responding to the Board's questions. The argument is not an evidentiary hearing, and the participants therefore should not attempt to introduce evidence during the argument. The participants should advise the Board and the other participants no later than March 8, 2016 if they plan to refer to any type of visual aid during the argument. No material that is not already cited in the record before the Board should be used as a visual aid.
The public is welcome to attend the argument, but space is limited within the courtroom. Additionally, only the parties' designated representatives will be permitted to participate in the argument. Neither signs nor any manner of demonstration will be permitted in the courtroom. Those people wishing to attend the oral argument in person should contact the Board's law clerk, Cooper Strickland, at 301-415-5880 or
Sometime after March 15, 2016, a transcript of the oral argument will be available for public inspection electronically on the NRC's Electronic Hearing Docket (EHD). EHD is accessible from the NRC Web site at
It is so
For The Atomic Safety and Licensing Board.
Nuclear Regulatory Commission.
Exemption; issuance.
The U.S. Nuclear Regulatory Commission (NRC) is issuing an exemption in response to a September 1, 2015, request from Maine Yankee Atomic Power Company, (MYAPC or licensee) from the requirement to comply with the terms, conditions, and specifications regarding the method of compliance defined in Amendment 5 of the NAC International (NAC)-UMS System Certificate of Compliance (CoC) No. 1015, Appendix A “Technical Specifications for NAC-UMS System”, Technical Specifications (TS) A.5.4 “Surveillance After an Off-Normal, Accident, or Natural Phenomena Event” at the Maine Yankee (MY) Independent Spent Fuel Storage Installation (ISFSI). The exemption request seeks a modification of TS A.5.4 inspection requirements for the inlet and outlet vents following off-normal, accident, and natural phenomena events.
Please refer to Docket ID NRC-2016-0028 when contacting the NRC about the availability of information regarding this document. You may obtain publicly-available information related to this document using any of the following methods:
• Federal Rulemaking Web site: Go to
• NRC's Agencywide Documents Access and Management System (ADAMS): You may obtain publicly
• NRC's PDR: You may examine and purchase copies of public documents at the NRC's PDR, Room O1-F21, One White Flint North, 11555 Rockville Pike, Rockville, Maryland 20852.
John Goshen, Office of Nuclear Material Safety and Safeguards, telephone: 301-415-6933, email:
The licensee is the holder of Facility Operating License No. DPR 36 which authorizes operation of MY located near Wiscasset, Maine, pursuant to part 50 of title 10 of the
Under Subpart K of 10 CFR part 72, a general license has been issued for the storage of spent fuel in an ISFSI at power reactor sites to persons authorized to possess or operate nuclear power reactors under 10 CFR part 50. Maine Yankee Atomic Power Company is licensed to operate a nuclear power reactor under 10 CFR part 50, and authorized under the 10 CFR part 72 general license to store spent fuel at the MY ISFSI. Under the terms of the general license, MY stores spent fuel using Amendment No. 5 of the NAC-UMS CoC No. 1015.
The licensee requests an exemption from 10 CFR 72.212(b)(3), 10 CFR 72.212(b)(5)(i), and 10 CFR 72.214 for the MY ISFSI.
• Section 72.212(b)(3) requires that a general licensee use casks that conform to the terms, conditions, and specifications of a CoC or amended CoC listed in § 72.214. The NAC-UMS CoC No. 1015 is listed in 10 CFR 72.214.
• Section 72.212(b)(5)(i) requires, in relevant part, that a general licensee demonstrate a loaded cask will conform to the terms, conditions, and specifications of a CoC for a cask listed in § 72.214.
• Section 72.214 lists casks which are approved for storage of spent fuel under conditions specified in their CoCs, including CoC 1015 and Amendment No. 5.
The licensee, as a 10 CFR 72 general licensee, is required to use the NAC-UMS System according to the TS of the NAC-UMS System CoC No. 1015. Amendment No. 5 of the NAC-UMS CoC No. 1015, Appendix A, “Technical Specifications for the NAC-UMS System.” Technical specification A 5.4, “Surveillance After an Off-Normal, Accident, or Natural Phenomena Event” requires that a general licensee undertake a visual surveillance of the NAC-UMS casks within 4 hours after the occurrence of an off-normal, accident or natural phenomena event in the area of the ISFSI. This NAC-UMS cask inspection is part of the general licensee's surveillance response to verify that all the CONCRETE CASK inlets and outlets are not blocked or obstructed. The NAC-UMS TS A 5.4 also requires that at least one-half of the inlets and outlets on each CONCRETE CASK be cleared of blockage or debris within 24 hours to restore air circulation.
The licensee seeks the NRC's authorization to use NAC-UMS TS A 3.1.6 as an alternative to the visual surveillance method specified in NAC-UMS TS A 5.4. Technical Specification A 3.1.6 permits
The proposed alternative for implementing TS A 5.4 provides that Surveillance Requirement (SR) 3.1.6.1 is required to be performed following off-normal, accident or natural phenomena events. The NAC-UMS SYSTEMs in use at an ISFSI shall be inspected in accordance with SR 3.1.6.1 within 4 hours after the occurrence of an off-normal, accident or natural phenomena event in the area of the ISFSI to confirm operability of the CONCRETE CASK Heat Removal System for each NAC-UMS System. If a CONCRETE CASK Heat Removal System(s) for one or more NAC-UMS Systems is determined to be inoperable, Condition A of TS A 3.1.6 shall be entered and the Required Actions and associated Completion Times met, including the immediate assurance of adequate heat removal to prevent exceeding short-term temperature limits for each affected cask.
The NAC-UMS Final Safety Analysis Report (FSAR) supports the use of either method defined in SR 3.1.6.1 to establish operability to comply with NAC-UMS TS A 3.1.6 or NAC-UMS TS A 5.4. Section 11.1.2.2 of the FSAR states, “Blockage of Half of the Air Inlets would be detected by the daily concrete cask operability inspection, which is performed either by the outlet air temperature measurements or by visual inspection of the inlet and outlet screens for blockage and integrity.”
Under 10 CFR 72.7, the Commission may, upon application by any interested person or upon its own initiative, grant an exemption from the requirements of 10 CFR part 72, the exemption is authorized by law, will not endanger life or property or the common defense and security and is otherwise in the public interest. As explained below, the proposed exemption is lawful, will not endanger life or property, or the common defense and security, and is otherwise in the public interest.
The exemption would permit the licensee to use either of the inspection methods permitted by NAC-UMS TS A 3.1.6 as an alternative to the single surveillance method in NAC-UMS TS A 5.4. The licensee would conduct a surveillance response within 4 hours after the occurrence of an off-normal, accident, or natural phenomena event, as required by NAC-UMS TS A 5.4, but would be permitted to use either temperature monitoring or visual inspection to ensure the Concrete Cask Heat Removal Systems are within the limiting conditions for operation. The exemption is limited to off-normal, accident, or natural phenomena events, specifically major snow or icing events (snow/ice events that have the potential to or that exceed blockage of greater than one-half of the inlet or outlet vents).
The licensee requested an exemption from the provisions in 10 CFR part 72 that requires the licensee to comply
The requested exemption would allow the licensee to use the SR, conditions, required actions, and completion times defined in NAC-UMS TS A 3.1.6 as an alternative to the single-method surveillance response in NAC-UMS TS A 5.4. TS A 3.1.6 permits
The NRC staff reviewed the licensee's request and finds allowing the use of either visual surveillance of the inlet and outlet screens or temperature monitoring of the inlets and outlets within 4 hours of the occurrence of off-normal, accident, or natural phenomena events, when limited to major snow and icing events, does not compromise safety. The exemption still requires the licensee to perform SR 3.1.6.1 to establish the operability of the Concrete Cask Heat Removal Systems every 24 hours via temperature monitoring or visual inspection of the inlet and outlet screens. In addition, the exemption provides no additional time to complete the required surveillance of the inlets and outlets screens in accordance with TS A 5.4. The use of either method will ensure that adequate air flows past the storage canisters and that heat transfer occurs. For these reasons, the NRC staff found the same level of safety is obtained by using either of the TS A 3.1.6 methods to comply with NAC-UMS TS A 5.4 during limited types off-normal, accident, or natural phenomena.
The NRC staff has determined that the thermal, structural, criticality, retrievability, and radiation protection requirements of 10 CFR part 72 and the offsite dose limits of 10 CFR part 20 will be maintained. For these reasons, the NRC staff finds the same level of safety is obtained by using either of the TS A 3.1.6 methods to comply with NAC-UMS TS A 5.4. Therefore, the NRC concludes that the exemption will not endanger life or property or the common defense and security.
As described in the application, exempting the licensee from visual surveillance of cask inlet and outlet vents within 4 hours of a major snowstorm would allow the licensee to prioritize more effectively important storm-related activities at the MY site. Snow and ice blockage of the inlet and outlet vents is unusual. Moreover, snow and ice blockages are identified reliably by temperature monitoring of individual casks. The NRC staff recognizes there is a risk to the safety of workers responsible for clearing snow and ice from cask pads during extreme winter conditions when visual surveillance of casks must be undertaken within 4 hours. The NRC staff finds this risk to workers can be reduced by using SR 3.1.6.1 to establish the operability of the Concrete Cask Heat Removal Systems via temperature monitoring or visual inspection of the inlet and outlet screens. In addition, the limiting conditions for operation of the NAC-UMS System require the Concrete Cask Heat Removal System for each cask to be operable during storage operation thus ensuring public health and safety are not reduced.
Therefore, the NRC staff finds that allowing the licensee to use the SR, conditions, required actions, and completion times defined in NAC-UMS TS A 3.1.6 as an alternative method to the single-method surveillance response in NAC-UMS TS A 5.4 would reduce worker safety risks to plant workers involved in snow removal. Therefore, granting the exemption is otherwise in the public interest.
The NRC staff evaluated whether there would be significant environmental impacts associated with the issuance of the requested exemption. The NRC staff determined the proposed action fits a category of actions that do not require an environmental assessment or environmental impact statement. The exemption meets the categorical exclusion requirements of 10 CFR 51.22(c)(25)(i)-(vi).
Granting an exemption from the requirements of 10 CFR 72.212(b)(3), 10 CFR 72.212(b)(5)(i), and 10 CFR 72.214 for the MY ISFSI involves the inspection and surveillance requirements associated with TS A 5.4. A categorical exclusion for inspection and SRs is provided under 10 CFR 51.22(c)(25)(vi)(C), if the criteria in 10 CFR 51.22(c)(25)(i)-(v) are also satisfied.
The granting of the exemption: (i) Would not involve a significant hazards consideration because it does not reduce a margin of safety, create a new or different kind of accident not previously evaluated, or significantly increase the probability or consequences of an unevaluated accident; (ii) would not create a significant change in the types or significant increase in the amounts of any effluents that may be released offsite because the exemption does not change or produce additional avenues of effluent release; (iii) would not significantly increase individual or cumulative public or occupational radiation exposure because the exemption does not introduce new or increased radiological hazards; (iv) would not result in significant construction impacts because the exemption would not involve construction or other ground disturbing activities, nor change the footprint of the existing ISFSI; (v) would not significantly increase the potential for or consequences from radiological accidents because the exemption requires a surveillance method that ensures the heat removal system of casks is maintained within the limiting conditions for operation; and (vi) the request seeks exemption from inspection or surveillance requirements, specifically, the single-method SR in NAC-UMS TS A 5.4 may be substituted with the SR, conditions, required actions, and completion times defined in NAC-UMS TS A 3.1.6.
In its review of the exemption request, the NRC staff determined the proposed exemption meets the eligibility criterion for categorical exclusion in 10 CFR 51.22(c)(25). Therefore, there are no significant radiological environmental impacts associated with the proposed action.
The NRC has determined that, under 10 CFR 72.7, the exemption is authorized by law, will not endanger life or property or the common defense and security, and is otherwise in the public interest. Therefore, the NRC
This exemption is effective upon issuance.
For the Nuclear Regulatory Commission.
Overseas Private Investment Corporation (OPIC).
Notice and request for comments.
Under the provisions of the Paperwork Reduction Act (44 U.S.C. Chapter 35), agencies are required to publish a Notice in the
Comments must be received within sixty (60) calendar days of publication of this Notice.
Mail all comments and requests for copies of the subject form to OPIC's Agency Submitting Officer: James Bobbitt, Overseas Private Investment Corporation, 1100 New York Avenue NW., Washington, DC 20527. See
OPIC Agency Submitting Officer: James Bobbitt, (202)336-8558.
All mailed comments and requests for copies of the subject form should include form number [OPIC-258] on both the envelope and in the subject line of the letter. Electronic comments and requests for copies of the subject form may be sent to
Postal Regulatory Commission.
Notice.
The Commission is noticing a recent Postal Service filing concerning an amendment to Priority Mail Contract 113 negotiated service agreement. This notice informs the public of the filing, invites public comment, and takes other administrative steps.
Submit comments electronically via the Commission's Filing Online system at
David A. Trissell, General Counsel, at 202-789-6820.
On February 10, 2016, the Postal Service filed notice that it has agreed to an amendment to the existing Priority Mail Contract 113 negotiated service agreement approved in this docket.
The Postal Service also filed the unredacted Amendment under seal. The Postal Service seeks to incorporate by reference the Application for Non-Public Treatment originally filed in this docket for the protection of information that it has filed under seal.
The Amendment adds an alternative provision for the adjustment of prices in subsequent contract years. Amendment at 1. The Postal Service intends for the Amendment to become effective 1 business day after the date that the Commission completes its review of the Notice. Notice at 1. The Postal Service asserts that the Amendment will not materially affect the cost coverage of Priority Mail Contract 113.
The Commission invites comments on whether the changes presented in the Postal Service's Notice are consistent with the policies of 39 U.S.C. 3632, 3633, or 3642, 39 CFR 3015.5, and 39
The Commission appoints Kenneth R. Moeller to represent the interests of the general public (Public Representative) in this docket.
1. The Commission reopens Docket No. CP2015-43 for consideration of matters raised by the Postal Service's Notice.
2. Pursuant to 39 U.S.C. 505, the Commission appoints Kenneth R. Moeller to serve as an officer of the Commission (Public Representative) to represent the interests of the general public in this proceeding.
3. Comments are due no later than February 19, 2016.
4. The Secretary shall arrange for publication of this order in the
By the Commission.
In accordance with the Paperwork Reduction Act of 1995 (44 U.S.C. Chapter 35), the Railroad Retirement Board (RRB) is forwarding three Information Collection Requests (ICR) to the Office of Information and Regulatory Affairs (OIRA), Office of Management and Budget (OMB). Our ICR describes the information we seek to collect from the public. Review and approval by OIRA ensures that we impose appropriate paperwork burdens.
The RRB invites comments on the proposed collections of information to determine (1) the practical utility of the collections; (2) the accuracy of the estimated burden of the collections; (3) ways to enhance the quality, utility, and clarity of the information that is the subject of collection; and (4) ways to minimize the burden of collections on respondents, including the use of automated collection techniques or other forms of information technology. Comments to the RRB or OIRA must contain the OMB control number of the ICR. For proper consideration of your comments, it is best if the RRB and OIRA receive them within 30 days of the publication date.
Under Section 2(d) of the Railroad Retirement Act (RRA), monthly survivor annuities are payable to surviving widow(er)s, parents, unmarried children, and in certain cases, divorced spouses, mothers (fathers), remarried widow(er)s, and grandchildren of deceased railroad employees if there are no qualified survivors of the employee immediately eligible for an annuity. The requirements relating to the annuities are prescribed in 20 CFR 216, 217, 218, and 219.
To collect the information needed to help determine an applicant's entitlement to, and the amount of, a survivor annuity the RRB uses Forms AA-17,
The AA-17 application process obtains information from an applicant about their marital history, work history, benefits from other government agencies, and Medicare entitlement for a survivor annuity. An RRB representative interviews the applicant either at a field office (preferred), an itinerant point, or by telephone. During the interview, the RRB representative enters the information obtained into an on-line information system. Upon completion of the interview, the on-line information system generates a summary of the information that was provided on either Form AA-17cert,
One response is requested of each respondent. Completion of the forms is required to obtain a benefit.
Section 2(c) of the Railroad Retirement Act (RRA), provides for the payment of annuities to spouses of railroad retirement annuitants who meet the requirements under the RRA. The age requirements for a spouse annuity depend on the employee's age, date of retirement, and years of railroad service. The requirements relating to the annuities are prescribed in 20 CFR 216, 218, 219, 232, 234, and 295.
To collect the information needed to help determine an applicant's entitlement to, and the amount of, a spouse annuity the RRB uses Form AA-3,
The AA-3 application process gathers information from an applicant about their marital history, work history, benefits from other government agencies, railroad pensions and Medicare entitlement for a spouse annuity. An RRB representative interviews the applicant either at a field office (preferred), an itinerant point, or by telephone. During the interview, the RRB representative enters the information obtained into an on-line information system. Upon completion of the interview, the on-line information system generates a summary of the information that was provided on either Form AA-3cert,
One response is requested of each respondent. Completion of the forms is required to obtain a benefit.
Under Section 7(d) of the Railroad Retirement Act, the RRB administers the Medicare program for persons covered by the railroad retirement system. The collection obtains the information needed by Palmetto GBA, the Medicare carrier for railroad retirement beneficiaries, to pay claims for payments under Part B of the Medicare program. Authority for collecting the information is prescribed in 42 CFR 424.32.
The RRB currently utilizes Forms G-740S, Patient's Request for Medicare Payment, along with Centers for Medicare & Medicaid Services Form CMS-1500, to secure the information necessary to pay Part B Medicare Claims. One response is completed for each claim. Completion is required to obtain a benefit.
The burden estimate for the ICR is as follows:
Estimated annual number of respondents: See Justification (Item No. 12).
Total annual responses: 1.
Total annual reporting hours: 1.
Comments regarding the information collection should be addressed to Charles Mierzwa, Railroad Retirement Board, 844 North Rush Street, Chicago, Illinois, 60611-2092 or
On August 24, 2015, Financial Industry Regulatory Authority, Inc. (“FINRA”), on behalf of the following parties to the National Market System Plan for the Selection and Reservation of Securities Symbols (the “Plan”): BATS Exchange, Inc. (“BATS”), BOX Options Exchange, LLC (“BOX”), Chicago Board Options Exchange, Incorporated (“CBOE”), Chicago Stock Exchange, Inc. (“CHX”), EDGA Exchange, Inc. (“EDGA”), EDGX Exchange, Inc. (“EDGX”), FINRA, International Securities Exchange, LLC (“ISE”), NASDAQ OMX BX, Inc. (“BX”), NASDAQ OMX PHLX, Inc. (“Phlx”), The Nasdaq Stock Market LLC (“Nasdaq”), National Stock Exchange, Inc. (“NSX”), New York Stock Exchange, LLC (“NYSE”), NYSE MKT, LLC (“NYSE MKT”), and NYSE Arca, Inc. (“NYSE Arca”) (collectively with FINRA, the “Parties”), filed with the Securities and Exchange Commission (“Commission”), pursuant to Section 11A of the Securities Exchange Act of 1934 (“Act”)
The Plan was created to enhance the effectiveness and efficiency of the national market system and to provide for fair competition between the self-regulatory organizations (“SROs”) by establishing a uniform system for the selection and reservation of securities symbols. The Plan, among other things, sets forth the process for securing perpetual and limited-time reservations, the use of a waiting list, the right to reuse a symbol and the ability to request the release of a symbol.
Under Section IV(d) of the current Plan, if a Party ceases to use a symbol, such Party automatically has that symbol reserved for a period of 24 months, notwithstanding any other limits on the number of reserved symbols specified in the Plan.
The Parties are amending Section IV(d) of the Plan to clarify that, if a Party ceases use of a symbol, such Party may elect to release the symbol pursuant to paragraph (b)(5) of the Plan. If a Party does not release the symbol, such
The amendment also proposes a new requirement. Specifically, that where a symbol has become available for reuse by a new Party (
For example, the amendment would address situations where a Party had been using symbol WXYZ for a period of years to identify the security of a particular company and, following the dissolution of the company, symbol WXYZ is released by the Party that had been using it. Under the current Plan, the Party using WXYZ to identify the security of the dissolved company would have that symbol reserved for a period of 24 months, and, at any time within this 24-month period, pursuant to Section IV(b)(6) (Request for Release of a Symbol), any other Party may have requested the voluntary release of the symbol for reuse. The amendment to the Plan retains this same basic framework, but also explicitly addresses circumstances in which a Party does not reserve the symbol but elects to release the symbol pursuant to paragraph (b)(5), in which case the symbol becomes immediately available to be reused by another Party to identify a different security. Under the amendment to the Plan, at any time within 90 calendar days from the last day of its use to identify the old security, such symbol may not be reused to identify a new security unless the Party seeking to reuse the symbol obtains the consent of the Party that most recently released the symbol. The Party most recently releasing the symbol must reasonably determine that reuse would not cause investor confusion prior to providing its consent.
As is the case today, at no time may a Party reuse a symbol unless the Party seeking the reuse also reasonably determines that such use would not cause investor confusion. In making a reasonable determination as to whether the reuse of a symbol would cause investor confusion, Parties would consider factors such as the level of recent activity in the old security, including trading frequency, volume and the number of market maker quotes.
The Amendment also contains several technical and ministerial amendments. First, the Plan is being amended to update NSX's principal place of business from its former address of 440 South LaSalle Street, Suite 2600, Chicago, IL 60605 to its new address of 101 Hudson Street, Suite 1200, Jersey City, NJ 07302. This Amendment also reflects a name change by one of the Parties. Specifically, the “NYSE Alternext US LLC” is now called “NYSE MKT LLC.” Finally, the Parties also are amending the Plan to update the principal place of business for both EDGA and EDGX from its former address at 545 Washington Blvd., Jersey City, NJ 07310 to 8050 Marshall Drive, Lenexa, KS 66214.
The Parties believe that the Amendment provides for a fair and orderly approach that would be applied consistently by all Parties to facilitate investor protection, does not disparately affect any single Party, and thus, does not impose any burden on competition that is not necessary or appropriate in furtherance of the purposes of the Act.
The Parties will implement the Amendment upon Commission approval.
Interested persons are invited to submit written data, views, and arguments concerning the foregoing, including whether the Amendment is consistent with the Act. Comments may be submitted by any of the following methods:
• Use the Commission's Internet comment form (
• Send an email to
• Send paper comments in triplicate to Brent J. Fields, Secretary, Securities and Exchange Commission, 100 F Street NE., Washington, DC 20549-1090.
By the Commission.
Pursuant to Section 19(b)(1)
The Exchange proposes to change the co-location services offered by the Exchange to include a means for co-located Users to receive the NASDAQ TotalView Ultra (FGPA) market data feed through a wireless connection. In addition, the proposed rule change reflects changes to the NYSE Arca Options Fee Schedule (the “Options Fee Schedule”) and, through its wholly owned subsidiary NYSE Arca Equities, Inc. (“NYSE Arca Equities”), the NYSE Arca Equities Schedule of Fees and Charges for Exchange Services (the “Equities Fee Schedule” and, together with the Options Fee Schedule, the “Fee Schedules”) related to the proposed service. The proposed rule change is available on the Exchange's Web site at
In its filing with the Commission, the self-regulatory organization included statements concerning the purpose of, and basis for, the proposed rule change and discussed any comments it received on the proposed rule change. The text of those statements may be examined at the places specified in Item IV below. The Exchange has prepared summaries, set forth in sections A, B, and C below, of the most significant parts of such statements.
The Exchange proposes to change the co-location
The Commission has approved the Exchange's proposed rule change to provide a wireless connection to five market data feeds from third party markets.
As with the previously approved connectivity to Third Party Data through the wireless connection, the Exchange would utilize a network vendor to provide a wireless connection to TotalView Ultra through wireless connections from an Exchange access center to its data center in Mahwah, New Jersey, through a series of towers equipped with wireless equipment. To receive TotalView Ultra, the User would enter into a contract with NASDAQ, which would charge the User the applicable market data fees for TotalView Ultra. The Exchange would charge the User fees for the wireless connection to TotalView Ultra.
For each wireless connection to TotalView Ultra, a User would be charged a $5,000 non-recurring initial charge and a monthly recurring charge (“MRC”) of $11,000. The Exchange proposes to revise the Fee Schedules to reflect fees related to the connection to TotalView Ultra.
As with the previously approved wireless connections to Third Party Data, if a User purchased two wireless connections, it would pay two non-recurring initial charges, and the wireless connection would include the use of one port for connectivity to Third Party Data.
The Exchange proposes to offer the wireless connection to provide Users with an alternative means of connectivity to TotalView Ultra. Currently, Users can receive TotalView Ultra from wireless networks offered by third party vendors.
The wireless connection to the Third Party Data is expected to be available in January 2016, and no later than March 1, 2016. The Exchange will announce the date that the wireless connection to the Third Party Data will be available through a customer notice.
As is the case with all Exchange co-location arrangements, (i) neither a User nor any of the User's customers would be permitted to submit orders directly to the Exchange unless such User or customer is a member organization, a Sponsored Participant or an agent thereof (
The proposed change is not otherwise intended to address any other issues relating to co-location services and/or related fees, and the Exchange is not aware of any problems that Users would have in complying with the proposed change.
The Exchange believes that the proposed rule change is consistent with Section 6(b) of the Act,
The Exchange believes that the proposed service is not designed to permit unfair discrimination between customers, issuers, brokers, or dealers because the wireless connection toTotalView Ultra would provide Users with an alternative means of connectivity to TotalView Ultra. Users that do not opt to utilize the Exchange's proposed wireless connections would still be able to obtain TotalView Ultra through other methods, including, for example, from wireless networks offered by third party vendors, another User, through a telecommunications provider, or over the IP network. Users that opt to use wireless connections to TotalView Ultra would receive the TotalView Ultra that is available to all Users, as all market participants that contract with NASDAQ for TotalView Ultra may receive it.
The Exchange believes that this removes impediments to, and perfects the mechanisms of, a free and open market and a national market system and, in general, protects investors and the public interest because it would provide Users with choices with respect to the form and optimal latency of the connectivity they use to receive TotalView Ultra, allowing a User that opts to receive TotalView Ultra to select the connectivity and number of ports that better suit its needs, helping it tailor its data center operations to the requirements of its business operations.
The Exchange also believes that the proposed rule change is consistent with Section 6(b)(4) of the Act,
The Exchange believes that the proposed change is equitable and not unfairly discriminatory because it will result in fees being charged only to Users that voluntarily select to receive the corresponding services and because those services will be available to all Users. Furthermore, the Exchange believes that the services and fees proposed herein are not unfairly discriminatory and are equitably allocated because, in addition to the services being completely voluntary, they are available to all Users on an equal basis (
Overall, the Exchange believes that the proposed change is reasonable because the Exchange proposes to offer wireless connection to TotalView Ultra described herein as a convenience to Users, but in doing so would incur certain costs, including costs related to the data center facility, hardware and equipment and costs related to personnel required for initial installation and monitoring, support and maintenance of such services. The costs associated with the wireless connections are incrementally higher than fiber optics-based solutions due to the expense of the wireless equipment, cost of installation and testing and ongoing maintenance of the network. The Exchange believes that it is reasonable that a User that has already purchased wireless connections to other Third Party Data would be charged a non-recurring charge when it purchases a wireless connection to TotalView Ultra, because the Exchange would incur certain costs in installing the wireless connection to TotalView Ultra irrespective of whether the User had existing wireless connections to Third Party Data. Such costs related to initial installation include, in particular, costs related to personnel required for initial installation and testing. The costs associated with installing wireless connections are incrementally higher than those associated with installing fiber optics-based solutions.
The Exchange believes that the proposed pricing for the wireless connection to TotalView Ultra is reasonable because it allows Users to select the TotalView Ultra connectivity option that better suits their needs. The fees also reflect the benefit received by Users in terms of lower latency over the fiber optics option. The Exchange believes that the proposed waiver of the first month's MRC is reasonable as it would allow Users to test the receipt of the feed for a month before incurring any monthly recurring fees and may act as an incentive to Users to connect to TotalView Ultra.
Moreover, the fees are equity [sic] allocated and not unfairly discriminatory because the wireless connection to TotalView Ultra would provide Users with an alternative means of connectivity to TotalView Ultra. Users that do not opt to utilize the Exchange's proposed wireless connections would still be able to obtain TotalView Ultra through other methods, including, for example, from wireless networks offered by third party vendors, another User, through a telecommunications provider, or over the IP network. Users that opt to use wireless connections to TotalView Ultra would receive the TotalView Ultra that is available to all Users, as all market participants that contract with NASDAQ for TotalView Ultra may receive it.
For the reasons above, the proposed changes do not unfairly discriminate between or among market participants that are otherwise capable of satisfying any applicable co-location fees, requirements, terms and conditions established from time to time by the Exchange.
Finally, the Exchange believes that it is subject to significant competitive forces, as described below in the Exchange's statement regarding the burden on competition.
For these reasons, the Exchange believes that the proposed fees are reasonable, equitable, and not unfairly discriminatory.
In accordance with Section 6(b)(8) of the Act,
The Exchange believes that allowing Users to receive TotalView Ultra through a wireless connection will not impose any burden on competition that is not necessary or appropriate in furtherance of the purposes of the Act because such access will satisfy User demand for additional options for connectivity to TotalView Ultra. Currently, Users can receive TotalView Ultra from wireless networks offered by third party vendors. Based on the information available to it, the Exchange believes that its proposed wireless connection would provide data at the same or similar speed and at the same or similar cost as the other wireless networks. Accordingly, the proposed wireless connection to TotalView Ultra would provide Users with an additional wireless connectivity option, thereby enhancing competition.
The Exchange notes that the proposed wireless connection to TotalView Ultra would compete not just with other wireless connections to TotalView Ultra, but also with fiber optic network connections to TotalView Ultra, which may be more attractive to some Users as they are more reliable and less susceptible to weather conditions. Users that do not opt to utilize wireless connections would be able to obtain TotalView Ultra through other methods, including, for example, from another User, through a telecommunications provider, or over the IP network. In this way, the proposed changes would enhance competition by helping Users tailor their connectivity to TotalView Ultra to the needs of their business operations by allowing them to select the form and optimal latency of the connectivity they use to receive TotalView Ultra that best suits their needs, helping them tailor their data center operations to the requirements of their business operations.
The proposed wireless connection to TotalView Ultra would traverse wireless connections through a series of towers equipped with wireless equipment, including a pole on the grounds of the data center. The proposed wireless network would have exclusive rights to operate wireless equipment on the data center pole. The Exchange will not sell rights to third parties to operate wireless equipment on the pole, due to space limitations, security concerns, and the interference that would arise between equipment placed too closely together. In addition to space issues, there are contractual restrictions on the use of the roof that the Exchange has determined would not be met if it offered space on the roof for third party wireless equipment. Moreover, access to the pole or roof is not required for third parties to establish wireless networks that can compete with the Exchange's proposed service, as witnessed by the existing wireless networks currently serving Users. Based on the information available to it, the Exchange believes that its proposed wireless connection to TotalView Ultra would provide data at the same or similar speed, and at the same or similar cost, as its proposed wireless connection [sic], thereby enhancing competition.
Finally, the Exchange notes that it operates in a highly competitive market in which market participants can readily favor competing venues if they deem fee levels at a particular venue to be excessive. In such an environment, the Exchange must continually review, and consider adjusting, its services and related fees and credits to remain competitive with other exchanges. For the reasons described above, the Exchange believes that the proposed rule change reflects this competitive environment.
No written comments were solicited or received with respect to the proposed rule change.
The Exchange has filed the proposed rule change pursuant to Section 19(b)(3)(A)(iii) of the Act
A proposed rule change filed under Rule 19b-4(f)(6)
At any time within 60 days of the filing of such proposed rule change, the Commission summarily may temporarily suspend such rule change if it appears to the Commission that such action is necessary or appropriate in the public interest, for the protection of investors, or otherwise in furtherance of the purposes of the Act. If the Commission takes such action, the Commission shall institute proceedings under Section 19(b)(2)(B)
Interested persons are invited to submit written data, views, and arguments concerning the foregoing, including whether the proposed rule change is consistent with the Act. Comments may be submitted by any of the following methods:
• Use the Commission's Internet comment form (
• Send an email to
• Send paper comments in triplicate to Secretary, Securities and Exchange Commission, 100 F Street NE., Washington, DC 20549-1090.
For the Commission, by the Division of Trading and Markets, pursuant to delegated authority.
Pursuant to Section 19(b)(1) of the Securities Exchange Act of 1934 (“Act”)
The Exchange proposes to adopt a new NYSE Arca Equities Rule 8.900 to permit it to list and trade Managed Portfolio Shares, which are shares of actively managed exchange-traded funds (“ETFs”) for which the portfolio is disclosed in accordance with standard mutual fund disclosure rules. In addition, the Exchange proposes to list and trade shares of the following under proposed NYSE Arca Equities Rule 8.900: Precidian U.S. Managed Volatility Fund; Precidian Strategic Value; Precidian Large Cap Value; Precidian Focused Dividend Strategy; Precidian U.S. Large Cap Growth; Precidian U.S. Core Equity; Precidian U.S. Mid Cap Growth; Precidian Total Return; Precidian High Dividend Yield; Precidian Small Cap Dividend Value; Precidian Multi-factor Small Cap Core; Precidian Multi-factor Small Cap Growth; Precidian Large Cap Core Plus 130/30; Precidian Mid Cap Core Plus 130/30; and Precidian Small Cap Core Plus 130/30. The proposed rule change is available on the Exchange's Web site at
In its filing with the Commission, the self-regulatory organization included statements concerning the purpose of, and basis for, the proposed rule change and discussed any comments it received on the proposed rule change. The text of those statements may be examined at the places specified in Item IV below. The Exchange has prepared summaries, set forth in sections A, B, and C below, of the most significant parts of such statements.
The Exchange proposes to add new NYSE Arca Equities Rule 8.900 for the purpose of permitting the listing and trading, or trading pursuant to unlisted trading privileges (“UTP”), of Managed Portfolio Shares, which are securities issued by an actively managed open-end investment management company.
In addition to the above-mentioned proposed rule changes, the Exchange proposes to list and trade shares (“Shares”) of the following under proposed NYSE Arca Equities Rule 8.900: Precidian U.S. Managed Volatility Fund; Precidian Strategic Value; Precidian Large Cap Value; Precidian Focused Dividend Strategy; Precidian U.S. Large Cap Growth; Precidian U.S. Core Equity; Precidian U.S. Mid Cap Growth; Precidian Total Return; Precidian High Dividend Yield; Precidian Small Cap Dividend Value; Precidian Multi-factor Small Cap Core; Precidian Multi-factor Small Cap Growth; Precidian Large Cap Core Plus 130/30; Precidian Mid Cap Core Plus 130/30; and Precidian Small Cap Core Plus 130/30 (each, a “Fund” and, collectively, the “Funds”).
Proposed Rule 8.900 (a) provides that the Corporation will consider for trading, whether by listing or pursuant to UTP, Managed Portfolio Shares that meet the criteria of Rule 8.900.
Proposed Rule 8.900 (b) provides that Rule 8.900 is applicable only to Managed Portfolio Shares and that, except to the extent inconsistent with Rule 8.900, or unless the context otherwise requires, the rules and procedures of the Corporation's Board of Directors shall be applicable to the trading on the Corporation of such securities. Proposed Rule 8.900 (b) provides further that Managed Portfolio Shares are included within the definition of “security” or “securities” as such terms are used in the Rules of the Corporation.
Proposed Definitions. Proposed Rule 8.900(c)(1) defines the term “Managed
Proposed Rule 8.900(c)(2) defines the term “Verified Intraday Indicative Value (“VIIV”) as the estimated indicative value of a Managed Portfolio Share based on all of the issuer's holdings as of the close of business on the prior business day, priced and disseminated in one second intervals, and subject to validation by a pricing verification agent of the Investment Company that is responsible for comparing multiple independent pricing sources to establish the accuracy of the VIIV.
Proposed Rule 8.900(c)(3) defines the term “Redemption Unit” as a specified number of Managed Portfolio Shares.
Proposed Rule 8.900(c)(4) defines the term “Reporting Authority” in respect of a particular series of Managed Portfolio Shares as a reporting service designated by the issuer and acceptable to the Corporation or by the exchange that lists a particular series of Managed Portfolio Shares (if the Corporation is trading such series pursuant to UTP) as the official source for calculating and reporting information relating to such series, including, but not limited to, the VIIV, NAV, or other information relating to the issuance, redemption or trading of Managed Portfolio Shares. A series of Managed Portfolio Shares may have more than one Reporting Authority, each having different functions.
Proposed Rule 8.900(d) sets forth initial and continued listing criteria applicable to Managed Portfolio Shares. Proposed Rule 8.900(d)(1)(A) provides that, for each series of Managed Portfolio Shares, the Corporation will establish a minimum number of Managed Portfolio Shares required to be outstanding at the time of commencement of trading on the Corporation. In addition, proposed Rule 8.900(d)(1)(B) provides that the Corporation will obtain a representation from the issuer of each series of Managed Portfolio Shares that the NAV per share for the series will be calculated daily and that the NAV will be made available to all market participants at the same time.
Proposed Rule 8.900(d)(2) provides that each series of Managed Portfolio Shares will be listed and traded subject to application of the following continued listing criteria. Proposed Rule 8.900(d)(2)(A) provides that the VIIV for Managed Portfolio Shares will be widely disseminated by one or more major market data vendors every second during the Exchange's Core Trading Session (as defined in NYSE Arca Equities Rule 7.34).
Proposed Rule 8.900(d)(2)(B) provides that the Corporation will consider the suspension of trading in or removal from listing of a series of Managed Portfolio Shares under any of the following circumstances: (i) If, following the initial twelve-month period after commencement of trading on the Exchange of a series of Managed Portfolio Shares, there are fewer than 50 beneficial holders of the series of Managed Portfolio Shares for 30 or more consecutive trading days; (ii) if the value of the VIIV is no longer calculated or made available to all market participants at the same time; (iii) if the Investment Company issuing the Managed Portfolio Shares has failed to file any filings required by the Commission or if the Corporation is aware that the Investment Company is not in compliance with the conditions of any exemptive order or no-action relief granted by the Commission to the Investment Company with respect to the series of Managed Portfolio Shares; or (iv) if such other event shall occur or condition exists which, in the opinion of the Corporation, makes further dealings on the Corporation inadvisable.
Proposed Rule 8.900(d)(2)(C) provides that, upon notification to the Corporation by the Investment Company or its agent that (i) the prices from the multiple independent pricing sources to be validated by the Investment Company's pricing verification agent differ by more than 25 basis points for 60 seconds in connection with pricing of the VIIV, or (ii) that the VIIV of a series of Managed Portfolio Shares is not being priced and disseminated in one-second intervals, as required, the Corporation shall halt trading in the Managed Portfolio Shares as soon as practicable. Such halt in trading shall continue until the Investment Company or its agent notifies the Corporation that the prices from the independent pricing sources no longer differ by more than 25 basis points for 60 seconds or that the VIIV is being priced and disseminated as required. The Investment Company or its agent shall be responsible for monitoring that the VIIV is being priced and disseminated as required and whether the prices to be validated from multiple independent pricing sources differ by more than 25 basis points for 60 seconds. With respect to series of Managed Portfolio Shares trading on the Corporation pursuant to unlisted trading privileges, if a temporary interruption occurs in the pricing or dissemination of the applicable Verified Intraday Indicative Value and the listing market halts trading in such series, the Corporation, upon notification by the listing market of such halt due to such temporary interruption, will halt trading in such series. In addition, if the Exchange becomes aware that the NAV with respect to a series of Managed Portfolio Shares is not disseminated to all market participants at the same time, it will halt trading in such series until such time as the NAV is available to all market participants.
Proposed Rule 8.900(d)(2)(D) provides that, upon termination of an Investment Company, the Corporation requires that Managed Portfolio Shares issued in connection with such entity be removed from Corporation listing.
Proposed Rule 8.900(d)(2)(E) provides that voting rights shall be as set forth in the applicable Investment Company prospectus.
Proposed Rule 8.900(e), which relates to limitation of Corporation liability, provides that neither the Corporation, the Reporting Authority, nor any agent of the Corporation shall have any liability for damages, claims, losses or expenses caused by any errors, omissions, or delays in calculating or disseminating any current portfolio value; the VIIV; the current value of the portfolio of securities required to be deposited to the open-end management investment company in connection with issuance of Managed Portfolio Shares; the amount of any dividend equivalent payment or cash distribution to holders of Managed Portfolio Shares; NAV; or other information relating to the purchase, redemption, or trading of Managed Portfolio Shares, resulting from any negligent act or omission by
Proposed Commentary .01 to NYSE Arca Equities Rule 8.900 provides that the Corporation will file separate proposals under Section 19(b) of the Act before the listing and trading of Managed Portfolio Shares. Proposed Commentary .02 to NYSE Arca Equities Rule 8.900 provides that transactions in Managed Portfolio Shares will occur only during the Core Trading Session as specified in NYSE Arca Equities Rule 7.34(a)(3)(A).
Proposed Commentary .03 to NYSE Arca Equities Rule 8.900 provides that the Exchange will implement written surveillance procedures for Managed Portfolio Shares.
Proposed Commentary .04 to NYSE Arca Equities Rule 8.900 provides that Authorized Participants (as defined in the Investment Company's Form N-1A filed with the SEC) or non-Authorized Participant market makers redeeming Managed Portfolio Shares will sign an agreement with an agent (“Trusted Agent”) to establish a confidential account for the benefit of such Authorized Participant or non-Authorized Participant market maker that will receive all consideration from the issuer in a redemption. A Trusted Agent may not disclose the consideration received in a redemption except as required by law or as provided in the Investment Company's Form N-1A, as applicable.
Proposed Commentary .05 to NYSE Arca Equities Rule 8.900 provides that, if the investment adviser to the Investment Company issuing Managed Portfolio Shares is affiliated with a broker-dealer, or if any Trusted Agent is registered as a broker-dealer or is affiliated with a broker-dealer, such investment adviser or Trusted Agent will erect a “fire wall” between the investment adviser or Trusted Agent and (i) personnel of the broker-dealer or broker-dealer affiliate, as applicable, or (ii) the Authorized Participant or non-Authorized Participant market maker, as applicable, with respect to access to information concerning the composition and/or changes to such Investment Company portfolio. Personnel who make decisions on the Investment Company's portfolio composition must be subject to procedures designed to prevent the use and dissemination of material nonpublic information regarding the applicable Investment Company portfolio.
The Exchange proposes to amend NYSE Arca Equities Rule 7.34(a)(3)(A) to add securities described in NYSE Arca Equities Rule 8.900 to the securities for which the Core Trading Session shall conclude at 1:15:00 p.m. (Pacific Time) unless otherwise determined by the Corporation.
While funds issuing Managed Portfolio Shares will be actively-managed and, to that extent, will be similar to Managed Fund Shares, Managed Portfolio Shares differ from Managed Fund Shares in the following important respects. First, in contrast to Managed Fund Shares, which are actively-managed funds listed and traded under NYSE Arca Equities Rule 8.600
For each series of Managed Portfolio Shares, an estimated value—the VIIV— that reflects an estimated intraday value of a fund's portfolio will be disseminated. With respect to the Funds, the VIIV will be based upon all of a Fund's holdings as of the close of the prior business day and will be widely disseminated by one or more major market data vendors every second during the Exchange's Core Trading Session (normally, 9:30 a.m. to 4:00 p.m., Eastern Time (“E.T.”)). The dissemination of the VIIV will allow investors to determine the estimated intra-day value of the underlying portfolio of a series of Managed Portfolio Shares on a daily basis and will provide a close estimate of that value throughout the trading day. The VIIV should not be viewed as a “real-time” update of the NAV per Share of each Fund because the VIIV may not be calculated in the same manner as the NAV, which will be computed once a day, generally at the end of the business day. Unlike the VIIV, which will be based on consolidated midpoint of the bid ask spread, the NAV per Share will be based on the closing price on the primary market for each portfolio security. If there is no closing price for a particular portfolio security, such as when it the subject of a trading halt, a Fund will use fair value pricing. That fair value pricing will be carried over to the next day's VIIV until the first trade in that stock is reported unless the “Adviser” (defined below) deems a particular portfolio security to be illiquid and/or the available ongoing pricing information unlikely to be reliable. In such case, that fact will be immediately disclosed on each Fund's Web site, including the identity and weighting of that security in a Fund's portfolio, and the impact of that security on VIIV calculation, including the fair
The Exchange, after consulting with various Lead Market Makers that trade exchange-traded funds (“ETFs”) on the Exchange, believes that market makers will be able to make efficient and liquid markets priced near the VIIV as long as a VIIV is disseminated every second, market makers have knowledge of a Fund's means of achieving its investment objective even without daily disclosure of a Fund's underlying portfolio, and market makers are permitted to engage in “Bona Fide Arbitrage”, as described below. The Exchange believes that market makers will employ Bona Fide Arbitrage in addition to risk-management techniques such as “statistical arbitrage”, which is currently used throughout the financial services industry, to make efficient markets in exchange-traded products.
To enable market makers to engage in Bona Fide Arbitrage, on each “Business Day” (as defined below), before commencement of trading in Shares on the Exchange, the Funds will provide to a “Trusted Agent” (as described below) of each Authorized Participant or “Non-Authorized Participant Market Maker”
In addition, Authorized Participants will be able to instruct the Trusted Agent to buy or sell portfolio securities during the day and thereby engage in Bona Fide Arbitrage throughout the trading day. For example, if an Authorized Participant believes that Shares of a Fund are trading at a price that is higher than the value of its underlying portfolio based on the VIIV, the Authorized Participant may sell Shares short and instruct the Trusted Agent to buy portfolio securities for its Confidential Account. When the market price of a Fund's Shares falls in line with the value of the portfolio, the Authorized Participant can then close out its positions in both the Shares and the portfolio securities. The Authorized Participant's purchase of the portfolio securities into its Confidential Account, combined with the sale of Shares, may also create downward pressure on the price of Shares and/or upward pressure on the price of the portfolio securities, bringing the market price of Shares and the value of a Fund's portfolio securities closer together. Similarly, an Authorized Participant could buy Shares and instruct the Trusted Agent to sell the underlying portfolio securities from its Confidential Account in an attempt to profit when a Fund's Shares are trading at a discount to its portfolio. The Authorized Participant's purchase of a Fund's Shares in the secondary market, combined with the sale of the portfolio securities from its Confidential Account, may also create upward pressure on the price of Shares and/or downward pressure on the price of portfolio securities, driving the market price of Shares and the value of a Fund's portfolio securities closer together. The Adviser represents that it understands that, other than the confidential nature of the account, this process is identical to how many Authorized Participants currently arbitrage existing traditional ETFs.
Because other market participants can also engage in arbitrage activity without using the creation or redemption processes described above, the Confidential Account structure will be made available to any Non-Authorized Participant Market Maker that is willing to establish a Confidential Account. In that case, if a market participant believes that a Fund is overvalued relative to its underlying assets, the market participant may sell short Shares and instruct its Trusted Agent to buy portfolio securities in its Confidential Account, wait for the trading prices to move toward parity, and then close out the positions in both the Shares and the portfolio securities to realize a profit from the relative movement of their trading prices. Similarly, a market participant could buy Shares and instruct the Trusted Agent to sell the underlying portfolio securities in an attempt to profit when a Fund's Shares are trading at a discount to a Fund's underlying or reference assets. Any investor that is willing to transact through a broker-dealer that has established a Confidential Account with a Trusted Agent will have the same opportunity to engage in arbitrage activity. As discussed above, the trading of a Fund's Shares and the Fund's portfolio securities may bring the prices of a Fund's Shares and its portfolio assets closer together through market pressure. This type of arbitrage is referred to herein as “Bona Fide Arbitrage.”
The Exchange understands that traders use statistical analysis to derive correlations between different sets of instruments to identify opportunities to buy or sell one set of instruments when it is mispriced relative to the others. For Managed Portfolio Shares, market makers, in addition to employing Bona Fide Arbitrage, may use the knowledge of a Fund's means of achieving its investment objective, as described in the applicable Fund registration statement, to construct a hedging proxy for a Fund to manage a market maker's quoting risk in connection with trading Fund Shares. Market makers can then conduct statistical arbitrage between their hedging proxy (for example, the Russell 1000 Index) and Shares of a Fund, buying and selling one against the other over the course of the trading day. They will evaluate how their proxy performed in comparison to the price of a Fund's Shares, and use that analysis as well as knowledge of risk metrics, such as volatility and turnover, to enhance their proxy calculation to make it a more efficient hedge.
Market makers not intending to utilize Bona Fide Arbitrage, have indicated to the Exchange that, after the first few days of trading, there will be sufficient data to run a statistical analysis which will lead to spreads being tightened substantially around the VIIV. This is similar to certain other existing exchange traded products (for example, ETFs that invest in foreign securities that do not trade during U. S. trading hours), in which spreads may be generally wider in the early days of trading and then narrow as market makers gain more confidence in their real-time hedges.
The Shares of each Fund will be issued by Precidian ETFs Trust
As noted above, proposed Commentary .05 to NYSE Arca Equities Rule 8.900 provides that, if the investment adviser to the Investment Company issuing Managed Portfolio Shares is affiliated with a broker-dealer, or if any Trusted Agent is registered as a broker-dealer or is affiliated with a broker-dealer, such investment adviser or Trusted Agent will erect a “fire wall” between the investment adviser or Trusted Agent and (i) personnel of the broker-dealer or broker-dealer affiliate, as applicable, or (ii) the Authorized Participant or non-Authorized Participant market maker, as applicable, with respect to access to information concerning the composition and/or changes to such Investment Company portfolio. Personnel who make decisions on the Investment Company's portfolio composition must be subject to procedures designed to prevent the use and dissemination of material nonpublic information regarding the applicable Investment Company portfolio.
In the event (a) the Adviser or any sub-adviser becomes registered as a broker-dealer or becomes newly affiliated with a broker-dealer, or (b) any new adviser or sub-adviser is a registered broker-dealer, or becomes affiliated with a broker-dealer, it will implement a fire wall with respect to its relevant personnel or its broker-dealer affiliate regarding access to information concerning the composition and/or changes to the portfolio, and will be subject to procedures designed to prevent the use and dissemination of material non-public information regarding such portfolio.
The portfolio for each Fund will consist of U.S.-listed securities and shares issued by other U.S.-listed ETFs
The Precidian U.S. Managed Volatility Fund will typically invest primarily in securities of U.S. companies of all capitalization ranges. These securities may include common stocks, preferred stocks, ETFs and warrants. The Fund will seek to achieve an absolute return of the broad U.S. equity markets, but with a lower absolute volatility.
The Fund will pursue its investment objective by investing primarily in high dividend yielding common stocks with dividend growth potential. The Fund's security selection process involves screening and prioritizing stocks based on appropriate quantitative statistics. Those companies that rank as highly attractive in the screening process are closely scrutinized for inclusion in the portfolio using bottom-up fundamental proprietary research.
The Fund will invest primarily in large-capitalization companies, seeking consistent long-term performance. The Fund will follow a traditional value-oriented investment philosophy using a research-intensive approach.
The Fund will seek total return (including capital appreciation and current income) by employing a “buy and hold” strategy involving the periodic selection of high dividend yielding common stocks from the universe of Russell 3000 stocks.
The Fund will seek long-term capital growth. The Fund will seek to achieve its investment objective by investing primarily in equities or groups of equities that the Adviser believes will provide higher returns than the Russell 1000 Growth Index.
The Fund will seek high total return. The Fund will seek to achieve its investment objective by investing primarily in equities or groups of equities that the Adviser believes will provide higher returns than the S&P 500 Index.
The Fund will invest primarily in common stocks of mid-cap companies with market capitalizations similar to those within the universe of the Russell Mid-Cap Growth Index. The Fund will seek companies that have a history of or the potential to achieve above-average growth.
The Fund will seek total return, consisting of capital appreciation and
The Fund will seek to track a benchmark that provides broad exposure to U.S. companies that are dedicated to consistently paying larger-than-average dividends.
The Fund will seek long-term capital appreciation and current income through investments in small cap companies that the Fund believes are undervalued and typically pay a dividend. Such companies generally will have a market capitalization below $3.5 billion at the time of purchase.
The Fund's investment objective will be to provide long-term capital appreciation by investing primarily in a diversified portfolio of small cap equity securities that possess both value and growth characteristics.
The Fund's investment objective will be to provide long-term cap appreciation by primarily investing in a diversified portfolio of small cap equity securities.
The Fund will invest primarily in securities of large-capitalization companies with characteristics similar to those comprising the Russell 1000. The Fund will take long positions in securities that will likely appreciate more rapidly in rising markets and short positions in those that will likely decline faster in declining markets.
The Fund will invest primarily in equity securities of mid-cap companies with market capitalizations equal to those within the universe of the Russell Mid Cap Index. The Fund will take long positions in securities that will likely appreciate more rapidly in rising markets and short positions in those that will likely decline faster in declining markets.
The Fund will invest primarily in equity securities of small-cap companies with market capitalizations equal to those within the universe of the Russell Small Cap Index. The Fund will take long positions in securities that will likely appreciate more rapidly in rising markets and short positions in those that will likely decline faster in declining markets.
While each Fund, under normal market conditions, will invest primarily in U.S.-listed securities, as described above, each Fund may invest its remaining assets in other securities and financial instruments, as described below.
According to the Registration Statement, each Fund may enter into repurchase agreements. A repurchase agreement is an instrument under which the purchaser (
Each Fund may enter into reverse repurchase agreements, which involve the sale of securities with an agreement to repurchase the securities at an agreed-upon price, date and interest payment and have the characteristics of borrowing. Generally, the effect of such transactions is that the Fund can recover all or most of the cash invested in the portfolio securities involved during the term of the reverse repurchase agreement, while in many cases the Fund is able to keep some of the interest income associated with those securities.
Each Fund may invest a portion of its assets in cash or cash equivalents.
Each Fund may invest in the securities of other investment companies (including money market funds) to the extent allowed by law.
A Fund may not, with respect to 75% of its total assets, purchase securities of any issuer (except securities issued or guaranteed by the U.S. government, its agencies or instrumentalities or shares of investment companies) if, as a result, more than 5% of its total assets would be invested in the securities of such issuer; or (ii) acquire more than 10% of the outstanding voting securities of any one issuer (and for purposes of this policy, the issuer of the underlying security will be deemed to be the issuer of any respective depositary receipt).
A Fund may not invest 25% or more of its total assets in the securities of one or more issuers conducting their principal business activities in the same industry or group of industries. This limitation does not apply to investments in securities issued or guaranteed by the U.S. government, its agencies or instrumentalities, or shares of investment companies. A Fund will not invest 25% or more of its total assets in any investment company that so concentrates.
Each Fund may invest up to an aggregate amount of 15% of its net assets in illiquid assets (calculated at the time of investment),
According to the Registration Statement, each Fund will seek to qualify for treatment as a Regulated Investment Company (“RIC”) under the Internal Revenue Code.
The Shares of each Fund will conform to the initial and continued listing criteria under proposed Rule 8.900. The Funds will not invest in options, futures, forwards or swaps.
Each Fund's investments will be consistent with its investment objective and will not be used to enhance leverage. While a Fund may invest in inverse ETFs, a Fund will not invest in leveraged (
The Funds will not invest in non-U.S.-listed securities.
In connection with the creation and redemption of Creation Units (defined below), the delivery or receipt of any portfolio securities in-kind will be required to be effected through a confidential brokerage account (
Shares of each Fund will be issued in Creation Units of 25,000 or more Shares. The Funds will offer and sell Creation Units through the Distributor on a continuous basis at the NAV per Share next determined after receipt of an order in proper form. The NAV per Share of each Fund will be determined as of the close of regular trading on the New York Stock Exchange (“NYSE”) on each day that the NYSE is open. A “Business Day” is defined as any day that the Trust is open for business. The Funds will sell and redeem Creation Units only on Business Days. Applicants anticipate that the initially price of a Share will range from $20 to $30, and that the price of a Creation Unit initial will range from $1,000,000 to $5,000,000.
In order to keep costs low and permit each Fund to be as fully invested as possible, Shares will be purchased and redeemed in Creation Units and generally on an in-kind basis. Accordingly, except where the purchase or redemption will include cash under the limited circumstances described in the Registration Statement, purchasers will be required to purchase Creation Units by making an in-kind deposit of specified instruments (“Deposit Instruments”), and shareholders redeeming their Shares will receive an in-kind transfer of specified instruments (“Redemption Instruments”).
As noted above, each Authorized Participant will be required to establish a Confidential Account with a Trusted Agent and transact with each Fund through that Confidential Account.
Each Fund will issue Shares through the Distributor on a continuous basis at NAV. The Exchange represents that the issuance of Shares will operate in a manner substantially similar to that of other ETFs.
Each Fund will issue Shares only at the NAV per Share next determined after an order in proper form is received. The Trust will sell and redeem Shares on each such day and will not suspend the right of redemption or postpone the date of payment or satisfaction upon redemption for more than seven days, other than as provided by Section 22(d) of the 1940 Act.
Shares may be purchased from a Fund by an Authorized Participant for its own account or for the benefit of a customer. The Distributor will furnish acknowledgements to those placing such orders that the orders have been accepted, but the Distributor may reject any order which is not submitted in proper form, as described in a Fund's prospectus or Statement of Additional Information (“SAI”). Purchases of Shares will be settled in-kind or cash for an amount equal to the applicable NAV per Share purchased plus applicable “Transaction Fees”, as discussed below.
The NAV of each Fund is expected to be determined once each Business Day at a time determined by the Trust's
All orders to purchase Creation Units must be received by the Distributor no later than the scheduled closing time of the regular trading session on the NYSE (ordinarily 4:00 p.m. E.T.) (“Order Cut-Off Time”) in each case on the date such order is placed (“Transmittal Date”) in order for the purchaser to receive the NAV per Share determined on the Transmittal Date. In the case of custom orders, the order must be received by the Distributor, no later than 3:00 p.m. E.T., or such earlier time as may be designated by the Funds and disclosed to Authorized Participants.
The Trust may impose purchase or redemption transaction fees (“Transaction Fees”) in connection with the purchase or redemption of Shares from the Funds. The exact amounts of any such Transaction Fees will be determined by the Adviser but will not exceed 2%. The purpose of the Transaction Fees is to protect the continuing shareholders against possible dilutive transactional expenses, including operational processing and brokerage costs, associated with establishing and liquidating portfolio positions, including short positions, in connection with the purchase and redemption of Shares.
Only Authorized Participants and their customers will be able to acquire Shares at NAV directly from a Fund through the Distributor. The required payment must be transferred in the manner set forth in a Fund's SAI by the specified time on the third DTC settlement day following the day it is transmitted (the “Transmittal Date”). These investors and others will also be able to purchase Shares in secondary market transactions at prevailing market prices. Each Fund will reserve the right to reject any purchase order at any time.
Beneficial Owners may sell their Shares in the secondary market. Alternatively, investors that own enough Shares to constitute a Redemption Unit (currently, 25,000 Shares) or multiples thereof may redeem those Shares through the Distributor, which will act as the Trust's representative for redemption. The size of a Redemption Unit will be subject to change. Redemption orders for Redemption Units or multiples thereof must be placed by or through an Authorized Participant.
The Shares may be redeemed to a Fund in Redemption Unit size or multiples thereof as described below. Redemption orders of Redemption Units must be placed by or through an Authorized Participant (“AP Redemption Order”). Each Fund will establish an Order Cut-Off Time for redemption orders of Redemption Units in proper form. Redemption Units of the Fund will be redeemable at their NAV per Share next determined after receipt of a request for redemption by the Trust in the manner specified below before the Order Cut-Off Time. To initiate an AP Redemption Order, an Authorized Participant must submit to the Distributor an irrevocable order to redeem such Redemption Unit after the most recent prior Valuation Time but not later than the Order Cut-Off Time. The Order Cut-Off Time for a Fund may be its Valuation Time, or may be prior to the Valuation Time if the Board determines that an earlier Order Cut-Off Time for redemption of Redemption Units is necessary and is in the best interests of Fund shareholders.
Consistent with the provisions of Section 22(e) of the 1940 Act and Rule 22e-2 thereunder, the right to redeem will not be suspended, nor payment upon redemption delayed, except for: (1) Any period during which the NYSE is closed other than customary weekend and holiday closings, (2) any period during which trading on the NYSE is restricted, (3) any period during which an emergency exists as a result of which disposal by a Fund of securities owned by it is not reasonably practicable or it is not reasonably practicable for a Fund to determine its NAV, and (4) for such other periods as the Commission may by order permit for the protection of shareholders.
Redemptions will occur primarily in-kind, although redemption payments may also be made partly or wholly in cash.
The redemption basket will consist of the same securities for all Authorized Participants on any given day subject to the Adviser's ability to make minor
After receipt of a Redemption Order, a Fund's custodian (“Custodian”) will typically deliver securities to the Confidential Account on a pro rata basis (which securities are determined by the Adviser) with a value approximately equal to the value of the Shares
If the Authorized Participant would receive a security that it is restricted from receiving, a Fund will deliver cash equal to the value of that security.
To address odd lots, fractional shares, tradeable sizes or other situations where dividing securities is not practical or possible, the Adviser may make minor adjustments to the pro rata portion of portfolio securities selected for distribution to each redeeming Authorized Participant on such Business Day.
The Trust will accept a Redemption Order in proper form. A Redemption Order is subject to acceptance by the Trust and must be preceded or accompanied by an irrevocable commitment to deliver the requisite number of Shares. At the time of settlement, an Authorized Participant will initiate a delivery of the Shares versus subsequent payment against the proceeds, if any, of the sale of portfolio securities distributed to the applicable Confidential Account plus or minus any cash balancing amounts, and less the expenses of liquidation.
The NAV per Share of a Fund will be computed by dividing the value of the net assets of a Fund (
Shares of exchange-listed equity securities will be valued at market value, which will generally be determined using the last reported official closing or last trading price on the exchange or market on which the securities are primarily traded at the time of valuation. Repurchase and reverse repurchase agreements will be valued based on price quotations or other equivalent indications of value provided by a third-party pricing service. Money market funds will be valued based on price quotations or other equivalent indications of value provided by a third-party pricing service. Cash equivalents will generally be valued on the basis of independent pricing services or quotes obtained from brokers and dealers.
When last sale prices and market quotations are not readily available, are deemed unreliable or do not reflect material events occurring between the close of local markets and the time of valuation, investments will be valued using fair value pricing as determined in good faith by the Adviser under procedures established by and under the general supervision and responsibility of the Trust's Board of Trustees. Investments that may be valued using fair value pricing include, but are not limited to: (1) Securities that are not actively traded; (2) securities of an issuer that becomes bankrupt or enters into a restructuring; and (3) securities whose trading has been halted or suspended.
The frequency with which each Fund's investments will be valued using fair value pricing will primarily be a function of the types of securities and other assets in which the respective Fund will invest pursuant to its investment objective, strategies and limitations. If the Funds invest in open-end management investment companies registered under the 1940 Act (other than ETFs), they may rely on the NAVs of those companies to value the shares they hold of them.
Valuing the Funds' investments using fair value pricing involves the consideration of a number of subjective factors and thus the prices for those investments may differ from current market valuations. Accordingly, fair value pricing could result in a difference between the prices used to calculate NAV and the prices used to determine a Fund's VIIV, which could result in the market prices for Shares deviating from NAV. In cases where the fair value price of the security is materially different from the pricing data provided by the independent pricing sources and the Adviser determined that the ongoing pricing information is not likely to be reliable, the fair value will be used for calculation of the VIIV, and a Fund's Custodian will be instructed to disclose the identity and weight of the fair valued securities, as well as the fair value price being used for the security.
The Funds' Web site (
As noted above, a mutual fund is required to file with the Commission its complete portfolio schedules for the second and fourth fiscal quarters on Form N-SAR under the 1940 Act, and is required to file its complete portfolio schedules for the first and third fiscal quarters on Form N-Q under the 1940 Act, within 60 days of the end of the quarter. Form N-Q requires funds to file the same schedules of investments that are required in annual and semi-annual reports to shareholders. The Trust's SAI and each Fund's shareholder reports will be available free upon request from the Trust. These documents and forms may be viewed on-screen or downloaded from the Commission's Web site at
Information regarding market price and trading volume of the Shares will be continually available on a real-time basis throughout the day on brokers' computer screens and other electronic services. Information regarding the previous day's closing price and trading volume information for the Shares will be published daily in the financial section of newspapers. Updated price information for U.S. exchange-listed equity securities is available through major market data vendors or securities exchanges trading such securities. The intraday, closing and settlement prices of money market funds, repurchase agreements, reverse repurchase agreements and cash equivalents will be readily available from published or other public sources, or major market data vendors such as Bloomberg and Thomson Reuters. The NAV of any investment company security investment will be readily available on the Web site of the relevant investment company and from major market data vendors. Quotation and last sale information for the Shares will be available via the Consolidated Tape Association (“CTA”) high-speed line. In addition, the VIIV, as defined in NYSE Arca Equities Rule 8.900(c)(3) and as described further below, will be widely disseminated by one or more major market data vendors at least every second during the Exchange's Core Trading Session.
The VIIV, which is approximate value of each Fund's investments on a per Share basis, will be disseminated every second during the Exchange's Core Trading Session. The VIIV should not be viewed as a “real-time” update of NAV because the VIIV may not be calculated in the same manner as NAV, which is computed once per day.
The Exchange will disseminate the VIIV for each Fund in one-second intervals during the Core Trading Session, through the facilities of the CTA. The VIIV is essentially an intraday NAV calculation every second during the Core Trading Session. Each Fund will adopt procedures governing the calculation of the VIIV and will bear responsibility for the accuracy of its calculation. Pursuant to those procedures, the VIIV will include all accrued income and expenses of a Fund and will assure that any extraordinary expenses, booked during the day, that would be taken into account in calculating a Fund's NAV for that day are also taken into account in calculating the VIIV. For purposes of the VIIV, securities held by a Fund will be valued throughout the day based on the mid-point between the disseminated current national best bid and offer. The Adviser represents that, by utilizing the mid-point pricing for purposes of VIIV calculation, stale prices are eliminated and more accurate representation of the real time value of the underlying securities is provided to the market. Specifically, quotations based on the mid-point of bid/ask spreads more accurately reflect current market sentiment by providing real time information on where market participants are willing to buy or sell securities at that point in time. Using quotations rather than last sale information addresses concerns regarding the staleness of pricing information of less actively traded securities. Because quotations are updated more frequently than last sale information especially for inactive securities, the VIIV will be based on more current and accurate information. The use of quotations will also dampen the impact of any momentary spikes in the price of a portfolio security.
Each Fund will utilize two independent pricing sources to provide two independent sources of pricing information. Each Fund will also utilize a “Pricing Verification Agent” and establish a computer-based protocol that will permit the Pricing Verification Agent to continuously compare the two data streams from the independent pricing agents sources on a real time basis.
With respect to trading halts, the Exchange may consider all relevant factors in exercising its discretion to halt or suspend trading in the Shares of the Funds.
The Exchange deems the Shares to be equity securities, thus rendering trading in the Shares subject to the Exchange's existing rules governing the trading of equity securities. Shares will trade on the NYSE Arca Marketplace only during the Core Trading Session in accordance with NYSE Arca Equities Rule 7.34(a)(3)(A). As provided in NYSE Arca Equities Rule 7.6, Commentary .03, the minimum price variation (“MPV”) for
The Shares will conform to the initial and continued listing criteria under NYSE Arca Equities Rule 8.900. The Exchange represents that, for initial and/or continued listing, each Fund will be in compliance with Rule 10A-3 under the Act,
The Exchange represents that trading in the Shares will be subject to the existing trading surveillances, administered by regulatory staff of the Exchange or the FINRA on behalf of the Exchange, which are designed to detect violations of Exchange rules and applicable federal securities laws.
The surveillances referred to above generally focus on detecting securities trading outside their normal patterns, which could be indicative of manipulative or other violative activity. When such situations are detected, surveillance analysis follows and investigations are opened, where appropriate, to review the behavior of all relevant parties for all relevant trading violations.
FINRA, on behalf of the Exchange, or the regulatory staff of the Exchange, will communicate as needed regarding trading in the Shares, underlying stocks and ETFs with other markets and other entities that are members of the Intermarket Surveillance Group (“ISG”), and FINRA, on behalf of the Exchange, or the regulatory staff of the Exchange, may obtain trading information regarding trading such securities from such markets and other entities. In addition, the Exchange may obtain information regarding trading in the Shares, underlying stocks and ETFs from markets and other entities that are members of ISG or with which the Exchange has in place a comprehensive surveillance sharing agreement.
The Funds' Adviser will make available daily to FINRA and the Exchange the portfolio holdings of each Fund in order to facilitate the performance of the surveillances referred to above.
In addition, the Exchange also has a general policy prohibiting the distribution of material, non-public information by its employees.
Prior to the commencement of trading, the Exchange will inform its Equity Trading Permit (“ETP”) Holders in an Information Bulletin (“Bulletin”) of the special characteristics and risks associated with trading the Shares. Specifically, the Bulletin will discuss the following: (1) The procedures for purchases and redemptions of Shares; (2) NYSE Arca Equities Rule 9.2(a), which imposes a duty of due diligence on its ETP Holders to learn the essential facts relating to every customer prior to trading the Shares; (4) how information regarding the VIIV is disseminated; (5) the requirement that ETP Holders deliver a prospectus to investors purchasing newly issued Shares prior to or concurrently with the confirmation of a transaction; and (6) trading information.
In addition, the Bulletin will reference that the Funds are subject to various fees and expenses described in the Registration Statement. The Bulletin will discuss any exemptive, no-action, and interpretive relief granted by the Commission from any rules under the Act. The Bulletin will also disclose that the NAV for the Shares will be calculated after 4:00 p.m., E.T. each trading day.
The Exchange believes that the proposed rule change is consistent with Section 6(b) of the Act,
The Exchange believes that proposed Rule 8.900 is designed to prevent fraudulent and manipulative acts and practices in that the proposed rules relating to listing and trading of Managed Portfolio Shares provide specific initial and continued listing criteria required to be met by such securities. Proposed Rule 8.900(d) sets forth initial and continued listing criteria applicable to Managed Portfolio Shares. Proposed Rule 8.900(d)(1) provides that, for each series of Managed Portfolio Shares, the Corporation will establish a minimum number of Managed Portfolio Shares required to be outstanding at the time of commencement of trading. In addition, the Corporation will obtain a representation from the issuer of each series of Managed Portfolio Shares that the NAV per share for the series will be calculated daily and that the NAV will be made available to all market participants at the same time. Proposed Rule 8.900(d)(2) provides that each series of Managed Portfolio Shares will be listed and traded subject to application of the specified continued listing criteria, as described above. Proposed Rule 8.900(d)(2)(A) provides that the VIIV for Managed Portfolio Shares will be widely disseminated by one or more major market data vendors every second during the Exchange's Core Trading Session. Proposed Rule 8.900(d)(2)(C) provides that, upon notification to the Corporation by the Investment Company or its agent that (i) the prices from the multiple independent pricing sources to be validated by the Investment Company's pricing verification agent differ by more than 25 basis points for 60 seconds in connection with pricing of the VIIV, or (ii) that the VIIV of a series of Managed Portfolio Shares is not being priced and disseminated in one-second intervals, as required, the Corporation shall halt trading in the Managed Portfolio Shares as soon as practicable. Such halt in trading shall continue until the Investment Company or its agent notifies the Corporation that the prices from the independent pricing sources no longer differ by more than 25 basis points for 60 seconds or that the VIIV is being priced and disseminated as required. Proposed Commentary .05 to NYSE Arca Equities Rule 8.900 provides that, if the investment adviser to the Investment Company issuing Managed Portfolio Shares is affiliated with a broker-dealer, or if any Trusted Agent is registered as a broker-dealer or is affiliated with a broker-dealer, such
With respect to the proposed listing and trading of Shares of the Funds, the Exchange believes that the proposed rule change is designed to prevent fraudulent and manipulative acts and practices in that the Shares will be listed and traded on the Exchange pursuant to the initial and continued listing criteria in NYSE Arca Equities Rule 8.900. Price information for the exchange-listed equity securities held by the Funds will be available through major market data vendors or securities exchanges listing and trading such securities. All exchange-listed equity securities held by the Funds will be listed on national securities exchanges. The listing and trading of such securities is subject to rules of the exchanges on which they are listed and traded, as approved by the Commission. The Funds will primarily hold U.S.-listed securities or ETFs. Further, the Funds will not invest in options, futures or swaps. A Fund's investments will be consistent with its respective investment objective and will not be used to enhance leverage. The Funds will not invest in non-U.S.-listed securities. FINRA, on behalf of the Exchange, or the regulatory staff of the Exchange, will communicate as needed regarding trading in the Shares and underlying stocks and ETFs with other markets and other entities that are members of the ISG, and FINRA, on behalf of the Exchange, or the regulatory staff of the Exchange, may obtain trading information regarding trading such securities from such markets and other entities. In addition, the Exchange may obtain information regarding trading in the Shares, underlying stocks and ETFs from markets and other entities that are members of ISG or with which the Exchange has in place a comprehensive surveillance sharing agreement. A Trusted Agent will provide information related to creations and redemption of Creation Units to FINRA upon request. The Funds' Adviser will make available daily to FINRA and the Exchange the portfolio holdings of each Fund in order to facilitate the performance of the surveillances referred to above.
The Exchange, after consulting with various Lead Market Makers that trade ETFs on the Exchange, believes that market makers will be able to make efficient and liquid markets priced near the VIIV as long as an accurate VIIV is disseminated every second, market makers have knowledge of a fund's means of achieving its investment objective even without daily disclosure of a fund's underlying portfolio, and are able to engage in Bona Fide Arbitrage. The Exchange believes that market makers will employ risk-management techniques such as Bona Fide Arbitrage in addition to “statistical arbitrage”, which is currently used throughout the financial services industry, to make efficient markets in exchange traded products.
The Exchange understands that traders, in addition to employing Bona Fide Arbitrage, use statistical analysis to derive correlations between different sets of instruments to identify opportunities to buy or sell one set of instruments when it is mispriced relative to the others. For Managed Portfolio Shares, market makers utilizing statistical arbitrage use the knowledge of a fund's means of achieving its investment objective, as described in the applicable fund registration statement, to construct a hedging proxy for a fund to manage a market maker's quoting risk in connection with trading fund shares. Market makers will then conduct statistical arbitrage between their hedging proxy (for example, the Russell 1000 Index) and shares of a fund, buying and selling one against the other over the course of the trading day. Eventually, at the end of each day, they will evaluate how their proxy performed in comparison to the price of a fund's shares, and use that analysis as well as knowledge of risk metrics, such as volatility and turnover, to enhance their proxy calculation to make it a more efficient hedge.
Market makers who anticipate employing statistical arbitrage more often than Bona Fide Arbitrage, have indicated to the Exchange that, after the first few days of trading, there will be sufficient data to run a statistical analysis which will lead to spreads being tightened substantially around VIIV. This is similar to certain other existing exchange traded products (for example, ETFs that invest in foreign securities that do not trade during U. S. trading hours), in which spreads may be generally wider in the early days of trading and then narrow as market makers gain more confidence in their real-time hedges.
The Lead Market Makers also indicated that, as with some other new exchange-traded products, spreads may be generally wider in the early days of trading and would tend to narrow as market makers gain more confidence in the accuracy of their hedges and their ability to adjust these hedges in real-time relative to the published VIIV and gain an understanding of the applicable market risk metrics such as volatility and turnover, and as natural buyers and sellers enter the market. Other relevant factors cited by Lead Market Makers were that a fund's investment objectives are clearly disclosed in the applicable prospectus, the existence of quarterly portfolio disclosure, the capacity to engage in Bona Fide Arbitrage and the ability to create shares in creation unit size.
The Commission's concept release regarding “Actively Managed Exchange-Traded Funds” highlighted several issues that could impact the Commission's willingness to authorize the operation of an actively-managed ETF, including whether effective arbitrage of the ETF shares exists.
The real-time dissemination of a fund's VIIV, the ability for market makers to engage is riskless arbitrage through the Bona Fide Arbitrage mechanism, together with the right of Authorized Participants to create and redeem each day at the NAV, will be sufficient for market participants to value and trade shares in a manner that will not lead to significant deviations between the shares' Bid/Ask Price and NAV.
The pricing efficiency with respect to trading a series of Managed Portfolio Shares will generally rest on the ability of market participants to arbitrage between the shares and a fund's portfolio, in addition to the ability of market participants to assess a fund's underlying value accurately enough throughout the trading day in order to hedge positions in shares effectively. Professional traders not employing Bona Fide Arbitrage can buy shares that they perceive to be trading at a price less than that which will be available at a subsequent time, and sell shares they perceive to be trading at a price higher than that which will be available at a subsequent time. It is expected that, as part of their normal day-to-day trading activity, market makers assigned to shares by the Exchange, off-exchange market makers, firms that specialize in electronic trading, hedge funds and other professionals specializing in short-term, non-fundamental trading strategies will assume the risk of being “long” or “short” shares through such trading and will hedge such risk wholly or partly by simultaneously taking positions in correlated assets
With respect to trading of Shares of the Funds, the ability of market participants to buy and sell Shares at prices near the VIIV is dependent upon their assessment that the VIIV is a reliable, indicative real-time value for a Fund's underlying holdings. Market participants are expected to accept the VIIV as a reliable, indicative real-time value because (1) the VIIV will be calculated and disseminated based on a Fund's actual portfolio holdings, (2) the securities in which the Funds plan to invest are generally highly liquid and actively traded and therefore generally have accurate real time pricing available, and (3) market participants will have a daily opportunity to evaluate whether the VIIV at or near the close of trading is indeed predictive of the actual NAV.
The real-time dissemination of a Fund's VIIV, the ability for market makers to engage is riskless arbitrage through the Bona Fide Arbitrage mechanism, together with the ability of Authorized Participants to create and redeem each day at the NAV, will be crucial for market participants to value and trade Shares in a manner that will not lead to significant deviations between the Shares' Bid/Ask Price and NAV.
In a typical index-based ETF, it is standard for Authorized Participants to know what securities must be delivered in a creation or will be received in a redemption. For Managed Portfolio Shares, however, Authorized Participants do not need to know the securities comprising the portfolio of a Fund since creations and redemptions are handled through the Confidential Account mechanism. The Adviser represents that the in-kind creations and redemptions through a Confidential Account will preserve the integrity of the active investment strategy and eliminate the potential for “free riding” or “front-running”, while still providing investors with the advantages of the ETF structure.
The proposed rule change is designed to promote just and equitable principles of trade and to protect investors and the public interest in that the Exchange will obtain a representation from the issuer of an issue of Managed Portfolio Shares that the NAV per share of a fund will be calculated daily and that the NAV and will be made available to all market participants at the same time. Investors can also obtain a fund's SAI, shareholder reports, and its Form N-CSR and Form N-SAR. A fund's SAI and shareholder reports will be available free upon request from the applicable fund, and those documents and the Form N-CSR and Form N-SAR may be viewed on-screen or downloaded from the Commission's Web site. In addition, with respect to
The proposed rule change is designed to perfect the mechanism of a free and open market and, in general, to protect investors and the public interest in that it will facilitate the listing and trading of an additional type of actively-managed exchange-traded product that will enhance competition among market participants, to the benefit of investors and the marketplace. As noted above, the Exchange has in place surveillance procedures relating to trading in the Shares and may obtain information via ISG from other exchanges that are members of ISG or with which the Exchange has entered into a comprehensive surveillance sharing agreement. In addition, as noted above, investors will have ready access to information regarding the VIIV and quotation and last sale information for the Shares.
The Exchange does not believe that the proposed rule change will impose any burden on competition that is not necessary or appropriate in furtherance of the purposes of the Act. The Exchange believes the proposed rule change would permit listing and trading of another type of actively-managed ETF that has characteristics different from existing actively-managed and index ETFs, and would introduce additional competition among various ETF products to the benefit of investors.
No written comments were solicited or received with respect to the proposed rule change.
Within 45 days of the date of publication of this notice in the
(A) By order approve or disapprove the proposed rule change, or
(B) institute proceedings to determine whether the proposed rule change should be disapproved.
Interested persons are invited to submit written data, views, and arguments concerning the foregoing, including whether the proposed rule change is consistent with the Act. Comments may be submitted by any of the following methods:
• Use the Commission's Internet comment form (
• Send an email to
• Send paper comments in triplicate to Brent J. Fields, Secretary, Securities and Exchange Commission, 100 F Street NE., Washington, DC 20549-1090.
For the Commission, by the Division of Trading and Markets, pursuant to delegated authority.
Securities and Exchange Commission (“Commission”).
Notice of an application for an order under section 6(c) of the Investment Company Act of 1940 (the “Act”) for an exemption from sections 2(a)(32), 5(a)(1), 22(d), and 22(e) of the Act and rule 22c-1 under the Act, under
The Commission: Secretary, U.S. Securities and Exchange Commission, 100 F Street NE., Washington, DC 20549-1090; Applicants: the Trust and IPCM, 3500 Lacey Road, Downers Grove, IL 60515; IDI, 11 Greenway Plaza, Suite 1000, Houston, TX 77046.
Christine Y. Greenlees, Senior Counsel at (202) 551-6879, or Dalia Osman Blass, Assistant Director, at (202) 551-6821 (Division of Investment Management, Chief Counsel's Office).
The following is a summary of the application. The complete application may be obtained via the Commission's Web site by searching for the file number, or for an applicant using the Company name box, at
1. The Trust is a statutory trust organized under the laws of the State of Delaware and will be registered with the Commission as an open-end management investment company that offers multiple series.
2. IPCM will be the investment adviser to the Initial Self-Indexing Fund (defined below). IPCM is, and any other Adviser (defined below) will be, registered as an investment adviser under the Investment Advisers Act of 1940 (the “Advisers Act”). The Adviser may enter into sub-advisory agreements with one or more investment advisers to act as sub-advisers to particular Self-Indexing Funds (each, a “Sub-Adviser”). Any Sub-Adviser will either be registered under the Advisers Act or will not be required to register thereunder.
3. The Trust will enter into a distribution agreement with one or more distributors. Each distributor for a Self-Indexing Fund (defined below) will be a broker-dealer (“Broker”) registered under the Securities Exchange Act of 1934 (`Exchange Act”) and will act as distributor and principal underwriter (“Distributor”) of one or more of the Self-Indexing Funds. IDI, a broker-dealer registered under the Exchange Act, is a wholly-owned subsidiary of Invesco Ltd. and will act as the initial Distributor and principal underwriter of the Self-Indexing Funds. No Distributor is or will be affiliated with any Exchange (defined below).
4. Applicants request that the order apply to a new series, the PowerShares Quantitative U.S. Equity Portfolio (“Initial Self-Indexing Fund”), and any additional series of the Trust, that may be created in the future (“Future Self-Indexing Funds”), each of which will operate as an exchange traded fund (“ETF”) and will track a specified Affiliated Index (as defined below) comprised of domestic and/or foreign equity and/or fixed income securities (each, an “Underlying Index”). Any Future Self-Indexing Fund will (a) be advised by IPCM or an entity controlling, controlled by, or under common control with IPCM (each, an “Adviser”) and (b) comply with the terms and conditions of the application. The Initial Self-Indexing Fund and Future Self-Indexing Funds, together, are the “Self-Indexing Funds.”
5. Each Self-Indexing Fund will hold certain securities, currencies, other assets and other investment positions (“Portfolio Holdings”) selected to correspond generally to the performance of its Underlying Index. Certain of the Self-Indexing Funds will be based on Underlying Indexes that will be comprised of equity and/or fixed income securities issued by one or more of the following categories of issuers: (i) Domestic issuers and (ii) non-domestic issuers meeting the requirements for trading in U.S. markets. Other Self-Indexing Funds will be based on Underlying Indexes that will be comprised of foreign and domestic, or solely foreign, equity and/or fixed income securities (“Foreign Self-Indexing Funds”).
6. Applicants represent that each Self-Indexing Fund will invest at least 80% of its assets (excluding securities lending collateral) in the component securities of its respective Underlying Index (“Component Securities”) and TBA Transactions
7. A Self-Indexing Fund will utilize either a replication or representative sampling strategy to track its Underlying Index. A Self-Indexing Fund using a replication strategy will invest in the Component Securities of its Underlying Index in the same approximate proportions as in such Underlying Index. A Self-Indexing Fund using a representative sampling strategy will hold some, but not necessarily all, of the Component Securities of its Underlying Index. Applicants state that a Self-Indexing Fund using a representative sampling strategy will not be expected to track the performance of its Underlying Index with the same degree of accuracy as would an investment vehicle that invested in every Component Security of the Underlying Index with the same weighting as the Underlying Index. Applicants expect that each Self-Indexing Fund will have an annual tracking error relative to the performance of its Underlying Index of less than 5%.
8. The Self-Indexing Funds will be entitled to use their Underlying Indexes pursuant to either a licensing agreement with the Affiliated Index Provider (defined below) or a sub-licensing arrangement with the Adviser, which has or will have a licensing agreement with such Affiliated Index Provider.
9. Applicants recognize that the Self-Indexing Funds could raise concerns regarding the ability of the Affiliated Index Provider to manipulate the Underlying Index to the benefit or detriment of a Self-Indexing Fund. Applicants further recognize the potential for conflicts that may arise with respect to the personal trading activity of personnel of the Affiliated Index Provider who have knowledge of changes to an Underlying Index prior to the time that information is publicly disseminated.
10. Applicants propose that each day that the Trust, the NYSE and the national securities exchange (as defined in section 2(a)(26) of the Act) (an “Exchange”) on which the Self-Indexing Fund's Shares are primarily listed (“Listing Exchange”) are open for business, including any day that a Self-Indexing Fund is required to be open under section 22(e) of the Act (a “Business Day”), each Self-Indexing Fund will post on its Web site, before commencement of trading of Shares on the Exchange, the identities and quantities of the Portfolio Holdings that will form the basis for the Self-Indexing Fund's calculation of its NAV at the end of the Business Day.
11. In addition, applicants do not believe the potential for conflicts of interest raised by the Adviser's use of the Underlying Indexes in connection with the management of Self-Indexing Funds and the Affiliated Accounts will be substantially different from the potential conflicts presented by an adviser managing two or more registered funds. Both the Act and the Advisers Act contain various protections to address conflicts of interest where an adviser is managing two or more registered funds and these protections will also help address these conflicts with respect to the Self-Indexing Funds.
12. Each Adviser and any Sub-Adviser has adopted or will adopt, pursuant to rule 206(4)-7 under the Advisers Act, written policies and procedures designed to prevent violations of the Advisers Act and the rules thereunder. These include policies and procedures designed to minimize potential conflicts of interest among the Self-Indexing Funds and the Affiliated Accounts, such as cross trading policies, as well as those designed to ensure the equitable allocation of portfolio transactions and brokerage commissions. In addition, IPCM has adopted policies and procedures as required under section 204A of the Advisers Act, which are reasonably designed in light of the nature of its business to prevent the misuse, in violation of the Advisers Act or the Exchange Act or the rules thereunder, of material non-public information by the IPCM or associated persons (“Inside Information Policy”). Any other Adviser and/or Sub-Adviser will be required to adopt and maintain a similar Inside Information Policy. In accordance with the Code of Ethics
13. To the extent the Self-Indexing Funds transact with an Affiliated Person of an Adviser or Sub-Adviser, such transactions will comply with the Act, the rules thereunder and the terms and conditions of the requested order. In this regard, each Self-Indexing Fund's board of directors or trustees (“Board”) will periodically review the Self-Indexing Fund's use of an Affiliated Index Provider. Subject to the approval of the Self-Indexing Fund's Board, the Adviser, Affiliated Persons of the Adviser (“Adviser Affiliates”) and Affiliated Persons of any Sub-Adviser (“Sub-Adviser Affiliates”) may be authorized to provide custody, fund accounting and administration and transfer agency services to the Self-Indexing Funds. Any services provided by the Adviser, Adviser Affiliates, Sub-Adviser and Sub-Adviser Affiliates will be performed in accordance with the provisions of the Act, the rules under the Act and any relevant guidelines from the staff of the Commission.
14. The Shares of each Self-Indexing Fund will be purchased and redeemed in Creation Units and generally on an in-kind basis. Except where the purchase or redemption will include cash under the limited circumstances specified below, purchasers will be required to purchase Creation Units by making an in-kind deposit of specified instruments (“Deposit Instruments”), and shareholders redeeming their Shares will receive an in-kind transfer of specified instruments (“Redemption Instruments”).
15. Purchases and redemptions of Creation Units may be made in whole or in part on a cash basis, rather than in kind, solely under the following circumstances: (a) To the extent there is a Cash Amount; (b) if, on a given Business Day, the Self-Indexing Fund announces before the open of trading that all purchases, all redemptions or all purchases and redemptions on that day will be made entirely in cash; (c) if, upon receiving a purchase or redemption order from an Authorized Participant, the Self-Indexing Fund determines to require the purchase or redemption, as applicable, to be made entirely in cash;
16. Creation Units will consist of specified large aggregations of Shares,
17. Each Business Day, before the open of trading on the Listing Exchange, each Self-Indexing Fund will cause to be published through the NSCC the names and quantities of the instruments comprising the Deposit Instruments and the Redemption Instruments, as well as the estimated Cash Amount (if any), for that day. The list of Deposit Instruments and Redemption Instruments will apply until a new list is announced on the following Business Day, and there will be no intra-day changes to the list except to correct errors in the published list. Each Listing Exchange or other major market data provider will disseminate, every 15 seconds during regular Exchange trading hours, through the facilities of the Consolidated Tape Association or other widely disseminated means, an amount for each Self-Indexing Fund stated on a per individual Share basis representing the sum of (i) the estimated Cash Amount and (ii) the current value of the Deposit Instruments.
18. Transaction expenses, including operational processing and brokerage costs, will be incurred by a Self-Indexing Fund when investors purchase or redeem Creation Units in-kind and such costs have the potential to dilute the interests of the Self-Indexing Fund's existing shareholders. Each Self-Indexing Fund will impose purchase or redemption transaction fees (“Transaction Fees”) in connection with effecting such purchases or redemptions of Creation Units. In all cases, such Transaction Fees will be limited in accordance with requirements of the Commission applicable to management investment companies offering redeemable securities. Since the Transaction Fees are intended to defray the transaction expenses as well as to prevent possible shareholder dilution resulting from the purchase or redemption of Creation Units, the Transaction Fees will be borne only by such purchasers or redeemers.
19. Shares of each Self-Indexing Fund will be listed and traded individually on an Exchange. It is expected that one or more member firms of an Exchange will be designated to act as a market maker (each, a “Market Maker”) and maintain a market for Shares trading on the Exchange. Prices of Shares trading on an Exchange will be based on the current bid/offer market. Transactions involving the sale of Shares on an Exchange will be subject to customary brokerage commissions and charges.
20. Applicants expect that purchasers of Creation Units will include institutional investors and arbitrageurs. Market Makers, acting in their roles to provide a fair and orderly secondary market for the Shares, may from time to time find it appropriate to purchase or redeem Creation Units. Applicants expect that secondary market purchasers of Shares will include both institutional and retail investors.
21. Shares will not be individually redeemable, and owners of Shares may acquire those Shares from the Self-Indexing Fund, or tender such Shares for redemption to the Self-Indexing Fund, in Creation Units only. To redeem, an investor must accumulate enough Shares to constitute a Creation Unit. Redemption requests must be placed through an Authorized Participant. A redeeming investor may pay a Transaction Fee, calculated in the same manner as a Transaction Fee payable in connection with purchases of Creation Units.
22. Neither the Trust nor any Self-Indexing Fund will be advertised or marketed or otherwise held out as a traditional open-end investment company or a “mutual fund.” Instead, each Self-Indexing Fund will be marketed as an “ETF.” All marketing materials that describe the features or method of obtaining, buying or selling Creation Units, or Shares traded on an Exchange, or refer to redeemability, will prominently disclose that Shares are not individually redeemable and will disclose that the owners of Shares may acquire those Shares from the Self-Indexing Fund or tender such Shares for redemption to the Self-Indexing Fund in Creation Units only. The Self-Indexing Funds will provide copies of their annual and semi-annual shareholder reports to DTC Participants for distribution to beneficial owners of Shares.
1. Applicants request an order under section 6(c) of the Act for an exemption from sections 2(a)(32), 5(a)(1), 22(d), and 22(e) of the Act and rule 22c-1 under the Act, under section 12(d)(1)(J) of the Act for an exemption from sections 12(d)(1)(A) and (B) of the Act, and under sections 6(c) and 17(b) of the Act for an exemption from sections 17(a)(1) and 17(a)(2) of the Act.
2. Section 6(c) of the Act provides that the Commission may exempt any person, security or transaction, or any class of persons, securities or transactions, from any provision of the Act, if and to the extent that such exemption is necessary or appropriate in the public interest and consistent with the protection of investors and the purposes fairly intended by the policy and provisions of the Act. Section 17(b) of the Act authorizes the Commission to exempt a proposed transaction from section 17(a) of the Act if evidence establishes that the terms of the transaction, including the consideration to be paid or received, are reasonable and fair and do not involve overreaching on the part of any person concerned, and the proposed transaction is consistent with the policies of the registered investment company and the general provisions of the Act. Section 12(d)(1)(J) of the Act provides that the Commission may exempt any person, security, or transaction, or any class or classes of persons, securities or transactions, from any provisions of section 12(d)(1) if the exemption is consistent with the public interest and the protection of investors.
3. Section 5(a)(1) of the Act defines an “open-end company” as a management investment company that is offering for sale or has outstanding any redeemable security of which it is the issuer. Section 2(a)(32) of the Act defines a redeemable security as any security, other than short-term paper, under the terms of which the owner, upon its presentation to the issuer, is entitled to receive approximately a proportionate share of the issuer's current net assets, or the cash equivalent. Because Shares will not be individually redeemable, applicants request an order that would permit the Self-Indexing Funds to register as open-end management investment companies and issue Shares that are redeemable in Creation Units only. Applicants state that investors may purchase Shares in Creation Units and redeem Creation Units from each Self-Indexing Fund. Applicants further state that because Creation Units may always be purchased and redeemed at NAV, the price of Shares on the secondary market should not vary materially from NAV.
4. Section 22(d) of the Act, among other things, prohibits a dealer from selling a redeemable security that is currently being offered to the public by or through an underwriter, except at a current public offering price described in the prospectus. Rule 22c-1 under the Act generally requires that a dealer selling, redeeming or repurchasing a redeemable security do so only at a price based on its NAV. Applicants state that secondary market trading in Shares will take place at negotiated prices, not at a current offering price described in a Self-Indexing Fund's prospectus, and not at a price based on NAV. Thus, purchases and sales of Shares in the secondary market will not comply with section 22(d) of the Act and rule 22c-1 under the Act. Applicants request an exemption under section 6(c) from these provisions.
5. Applicants assert that the concerns sought to be addressed by section 22(d) of the Act and rule 22c-1 under the Act with respect to pricing are equally satisfied by the proposed method of pricing Shares. Applicants maintain that while there is little legislative history regarding section 22(d), its provisions, as well as those of rule 22c-1, appear to have been designed to (a) prevent dilution caused by certain riskless-trading schemes by principal underwriters and contract dealers, (b) prevent unjust discrimination or preferential treatment among buyers, and (c) ensure an orderly distribution of investment company shares by eliminating price competition from dealers offering shares at less than the published sales price and repurchasing shares at more than the published redemption price.
6. Applicants believe that none of these purposes will be thwarted by permitting Shares to trade in the secondary market at negotiated prices. Applicants state that (a) secondary market trading in Shares does not involve a Self-Indexing Fund as a party and will not result in dilution of an investment in Shares, and (b) to the extent different prices exist during a given trading day, or from day to day, such variances occur as a result of third-party market forces, such as supply and demand. Therefore, applicants assert that secondary market transactions in Shares will not lead to discrimination or preferential treatment among purchasers. Finally, applicants contend that the price at which Shares trade will be disciplined by arbitrage opportunities created by the option continually to purchase or redeem Shares in Creation Units, which should help prevent Shares from trading at a material discount or premium in relation to their NAV.
7. Section 22(e) of the Act generally prohibits a registered investment company from suspending the right of redemption or postponing the date of payment of redemption proceeds for more than seven days after the tender of a security for redemption. Applicants state that settlement of redemptions for Foreign Self-Indexing Funds will be contingent not only on the settlement cycle of the United States market, but also on current delivery cycles in local markets for the underlying foreign securities held by a Foreign Self-Indexing Fund. Applicants state that the delivery cycles currently practicable for transferring Redemption Instruments to redeeming investors, coupled with local market holiday schedules, may require a delivery process of up to fourteen (14) calendar days. Accordingly, with respect to Foreign Self-Indexing Funds only, applicants hereby request relief under section 6(c) from the requirement imposed by section 22(e) to allow Foreign Self-Indexing Funds to pay redemption proceeds within fourteen (14) calendar days following the tender of Creation Units for redemption.
8. Applicants believe that Congress adopted section 22(e) to prevent unreasonable, undisclosed or unforeseen delays in the actual payment of redemption proceeds. Applicants propose that allowing redemption payments for Creation Units of a Foreign Self-Indexing Fund to be made within fourteen calendar days would not be inconsistent with the spirit and intent of section 22(e). Applicants suggest that a redemption payment occurring within fourteen calendar days following a redemption request would adequately afford investor protection.
9. Applicants are not seeking relief from section 22(e) with respect to Foreign Self-Indexing Funds that do not effect creations and redemptions of Creation Units in-kind.
10. Section 12(d)(1)(A) of the Act prohibits a registered investment company from acquiring securities of an investment company if such securities represent more than 3% of the total outstanding voting stock of the acquired company, more than 5% of the total assets of the acquiring company, or, together with the securities of any other investment companies, more than 10% of the total assets of the acquiring company. Section 12(d)(1)(B) of the Act prohibits a registered open-end investment company, its principal underwriter and any other broker-dealer from knowingly selling the investment company's shares to another investment company if the sale will cause the acquiring company to own more than 3% of the acquired company's voting stock, or if the sale will cause more than 10% of the acquired company's voting stock to be owned by investment companies generally.
11. Applicants request an exemption to permit registered management investment companies and unit investment trusts (“UITs”) that are not advised or sponsored by the Adviser and are not part of the same “group of investment companies,” as defined in section 12(d)(1)(G)(ii) of the Act as the Self-Indexing Funds (such management investment companies are referred to as “Investing Management Companies,” such UITs are referred to as “Investing Trusts,” and Investing Management Companies and Investing Trusts are collectively referred to as “Funds of Funds”), to acquire Shares beyond the limits of section 12(d)(1)(A) of the Act; and the Self-Indexing Funds, and any principal underwriter for the Self-
12. Each Investing Management Company will be advised by an investment adviser within the meaning of section 2(a)(20)(A) of the Act (the “Fund of Funds Adviser”) and may be sub-advised by investment advisers within the meaning of section 2(a)(20)(B) of the Act (each a “Fund of Funds Sub-Adviser”). Any investment adviser to an Investing Management Company will be registered under the Advisers Act. Each Investing Trust will be sponsored by a sponsor (“Sponsor”).
13. Applicants submit that the proposed conditions to the requested relief adequately address the concerns underlying the limits in sections 12(d)(1)(A) and (B), which include concerns about undue influence by a fund of funds over underlying funds, excessive layering of fees and overly complex fund structures. Applicants believe that the requested exemption is consistent with the public interest and the protection of investors.
14. Applicants believe that neither a Fund of Funds nor a Fund of Funds Affiliate would be able to exert undue influence over a Self-Indexing Fund.
15. Applicants propose other conditions to limit the potential for undue influence over the Self-Indexing Funds, including that no Fund of Funds or Fund of Funds Affiliate (except to the extent it is acting in its capacity as an investment adviser to a Self-Indexing Fund) will cause a Self-Indexing Fund to purchase a security in an offering of securities during the existence of an underwriting or selling syndicate of which a principal underwriter is an Underwriting Affiliate (“Affiliated Underwriting”). An “Underwriting Affiliate” is a principal underwriter in any underwriting or selling syndicate that is an officer, director, member of an advisory board, Fund of Funds Adviser, Fund of Funds Sub-Adviser, employee or Sponsor of the Fund of Funds, or a person of which any such officer, director, member of an advisory board, Fund of Funds Adviser or Fund of Funds Sub-Adviser, employee or Sponsor is an affiliated person (except that any person whose relationship to the Self-Indexing Fund is covered by section 10(f) of the Act is not an Underwriting Affiliate).
16. Applicants do not believe that the proposed arrangement will involve excessive layering of fees. The board of directors or trustees of any Investing Management Company, including a majority of the directors or trustees who are not “interested persons” within the meaning of section 2(a)(19) of the Act (“disinterested directors or trustees”), will find that the advisory fees charged under the contract are based on services provided that will be in addition to, rather than duplicative of, services provided under the advisory contract of any Self-Indexing Fund in which the Investing Management Company may invest. In addition, under condition B.5., a Fund of Funds Adviser, or a Fund of Funds' trustee or Sponsor, as applicable, will waive fees otherwise payable to it by the Fund of Funds in an amount at least equal to any compensation (including fees received pursuant to any plan adopted by a Self-Indexing Fund under rule 12b-1 under the Act) received from a Self-Indexing Fund by the Fund of Funds Adviser, trustee or Sponsor or an affiliated person of the Fund of Funds Adviser, trustee or Sponsor, other than any advisory fees paid to the Fund of Funds Adviser, trustee or Sponsor or its affiliated person by a Self-Indexing Fund, in connection with the investment by the Fund of Funds in the Self-Indexing Fund. Applicants state that any sales charges and/or service fees charged with respect to shares of a Fund of Funds will not exceed the limits applicable to a fund of funds as set forth in NASD Conduct Rule 2830.
17. Applicants submit that the proposed arrangement will not create an overly complex fund structure. Applicants note that no Self-Indexing Fund will acquire securities of any investment company or company relying on section 3(c)(1) or 3(c)(7) of the Act in excess of the limits contained in section 12(d)(1)(A) of the Act, except to the extent permitted by exemptive relief from the Commission permitting the Self-Indexing Fund to purchase shares of other investment companies for short-term cash management purposes. To ensure a Fund of Funds is aware of the terms and conditions of the requested order, the Fund of Funds will enter into an agreement with the Self-Indexing Fund (“FOF Participation Agreement”). The FOF Participation Agreement will include an acknowledgement from the Fund of Funds that it may rely on the order only to invest in the Self-Indexing Funds and not in any other investment company.
18. Applicants also note that a Self-Indexing Fund may choose to reject a direct purchase of Shares in Creation Units by a Fund of Funds. To the extent that a Fund of Funds purchases Shares in the secondary market, a Self-Indexing Fund would still retain its ability to reject any initial investment by a Fund of Funds in excess of the limits of section 12(d)(1)(A) by declining to enter into a FOF Participation Agreement with the Fund of Funds.
19. Sections 17(a)(1) and (2) of the Act generally prohibit an affiliated person of a registered investment company, or an affiliated person of such a person, from selling any security to or purchasing any security from the company. Section 2(a)(3) of the Act defines “affiliated person” of another person to include (a) any person directly or indirectly owning, controlling or holding with power to vote 5% or more of the outstanding voting securities of the other person, (b) any person 5% or more of whose outstanding voting securities are directly or indirectly owned, controlled or held with the power to
20. Applicants request an exemption from sections 17(a)(1) and 17(a)(2) of the Act pursuant to sections 6(c) and 17(b) of the Act to permit persons that are Affiliated Persons of the Self-Indexing Funds, or Second-Tier Affiliates of the Self-Indexing Funds, solely by virtue of one or more of the following: (a) Holding 5% or more, or in excess of 25%, of the outstanding Shares of one or more Self-Indexing Funds; (b) an affiliation with a person with an ownership interest described in (a); or (c) holding 5% or more, or more than 25%, of the shares of one or more Affiliated Funds, to effectuate purchases and redemptions “in-kind.”
21. Applicants assert that no useful purpose would be served by prohibiting such affiliated persons from making “in-kind” purchases or “in-kind” redemptions of Shares of a Self-Indexing Fund in Creation Units. Both the deposit procedures for “in-kind” purchases of Creation Units and the redemption procedures for “in-kind” redemptions of Creation Units will be effected in exactly the same manner for all purchases and redemptions, regardless of size or number. There will be no discrimination between purchasers or redeemers. Deposit Instruments and Redemption Instruments for each Self-Indexing Fund will be valued in the identical manner as those Portfolio Holdings currently held by such Self-Indexing Fund and the valuation of the Deposit Instruments and Redemption Instruments will be made in an identical manner regardless of the identity of the purchaser or redeemer. Applicants do not believe that “in-kind” purchases and redemptions will result in abusive self-dealing or overreaching, but rather assert that such procedures will be implemented consistently with each Self-Indexing Fund's objectives and with the general purposes of the Act. Applicants believe that “in-kind” purchases and redemptions will be made on terms reasonable to applicants and any affiliated persons because they will be valued pursuant to verifiable objective standards. The method of valuing Portfolio Holdings held by a Self-Indexing Fund is identical to that used for calculating “in-kind” purchase or redemption values and therefore creates no opportunity for affiliated persons or Second-Tier Affiliates of applicants to effect a transaction detrimental to the other holders of Shares of that Self-Indexing Fund. Similarly, applicants submit that, by using the same standards for valuing Portfolio Holdings held by a Self-Indexing Fund as are used for calculating “in-kind” redemptions or purchases, the Self-Indexing Fund will ensure that its NAV will not be adversely affected by such securities transactions. Applicants also note that the ability to take deposits and make redemptions “in-kind” will help each Self-Indexing Fund to track closely its Underlying Index and therefore aid in achieving the Self-Indexing Fund's objectives.
22. Applicants also seek relief under sections 6(c) and 17(b) from section 17(a) to permit a Self-Indexing Fund that is an affiliated person, or an affiliated person of an affiliated person, of a Fund of Funds to sell its Shares to and redeem its Shares from a Fund of Funds, and to engage in the accompanying in-kind transactions with the Fund of Funds.
Applicants agree that any order of the Commission granting the requested relief will be subject to the following conditions:
1. The requested relief to permit ETF operations will expire on the effective date of any Commission rule under the Act that provides relief permitting the operation of affiliated index-based ETFs.
2. As long as a Self-Indexing Fund operates in reliance on the requested order, the Shares of such Self-Indexing Fund will be listed on an Exchange.
3. Neither the Trust nor any Self-Indexing Fund will be advertised or marketed as an open-end investment company or a mutual fund. Any advertising material that describes the purchase or sale of Creation Units or refers to redeemability will prominently disclose that Shares are not individually redeemable and that owners of Shares may acquire those Shares from the Self-Indexing Fund and tender those Shares for redemption to a Self-Indexing Fund in Creation Units only.
4. The Web site, which is and will be publicly accessible at no charge, will contain, on a per Share basis for each Self-Indexing Fund, the prior Business Day's NAV and the market closing price or the midpoint of the bid/ask spread at the time of the calculation of such NAV (“Bid/Ask Price”), and a calculation of the premium or discount of the market closing price or Bid/Ask Price against such NAV.
5. Each Self-Indexing Fund will post on the Web site on each Business Day, before commencement of trading of Shares on the Exchange, the Self-Indexing Fund's Portfolio Holdings.
6. No Adviser or any Sub-Adviser to a Self-Indexing Fund, directly or indirectly, will cause any Authorized Participant (or any investor on whose behalf an Authorized Participant may transact with the Self-Indexing Fund) to acquire any Deposit Instrument for the Self-Indexing Fund through a transaction in which the Self-Indexing Fund could not engage directly.
1. The members of a Fund of Funds' Advisory Group will not control (individually or in the aggregate) a Self-Indexing Fund within the meaning of section 2(a)(9) of the Act. The members of a Fund of Funds' Sub-Advisory Group will not control (individually or in the aggregate) a Self-Indexing Fund within the meaning of section 2(a)(9) of the Act. If, as a result of a decrease in the outstanding voting securities of a Self-Indexing Fund, the Fund of Funds' Advisory Group or the Fund of Funds' Sub-Advisory Group, each in the aggregate, becomes a holder of more than 25 percent of the outstanding voting securities of a Self-Indexing Fund, it will vote its Shares of the Self-Indexing Fund in the same proportion as the vote of all other holders of the Self-Indexing Fund's Shares. This condition does not apply to the Fund of Funds' Sub-Advisory Group with respect to a Self-Indexing Fund for which the Fund of Funds' Sub-Adviser or a person controlling, controlled by or under common control with the Fund of Funds' Sub-Adviser acts as the investment adviser within the meaning of section 2(a)(20)(A) of the Act.
2. No Fund of Funds or Fund of Funds Affiliate will cause any existing or potential investment by the Fund of Funds in a Self-Indexing Fund to influence the terms of any services or transactions between the Fund of Funds or Fund of Funds Affiliate and the Self-Indexing Fund or a Self-Indexing Fund Affiliate.
3. The board of directors or trustees of an Investing Management Company, including a majority of the disinterested directors or trustees, will adopt procedures reasonably designed to ensure that the Fund of Funds Adviser and Fund of Funds Sub-Adviser are conducting the investment program of the Investing Management Company without taking into account any consideration received by the Investing Management Company or a Fund of Funds Affiliate from a Self-Indexing Fund or Self-Indexing Fund Affiliate in connection with any services or transactions.
4. Once an investment by a Fund of Funds in the securities of a Self-Indexing Fund exceeds the limits in section 12(d)(1)(A)(i) of the Act, the Board of the Self-Indexing Fund, including a majority of the directors or trustees who are not “interested persons” within the meaning of section 2(a)(19) of the Act (“non-interested Board members”), will determine that any consideration paid by the Self-Indexing Fund to the Fund of Funds or a Fund of Funds Affiliate in connection with any services or transactions: (i) Is fair and reasonable in relation to the nature and quality of the services and benefits received by the Self-Indexing Fund; (ii) is within the range of consideration that the Self-Indexing Fund would be required to pay to another unaffiliated entity in connection with the same services or transactions; and (iii) does not involve overreaching on the part of any person concerned. This condition does not apply with respect to any services or transactions between a Self-Indexing Fund and its investment adviser(s), or any person controlling, controlled by or under common control with such investment adviser(s).
5. The Fund of Funds Adviser, or trustee or Sponsor of an Investing Trust, as applicable, will waive fees otherwise payable to it by the Fund of Funds in an amount at least equal to any compensation (including fees received pursuant to any plan adopted by a Self-Indexing Fund under rule 12b-1 under the Act) received from a Self-Indexing Fund by the Fund of Funds Adviser, or trustee or Sponsor of the Investing Trust, or an affiliated person of the Fund of Funds Adviser, or trustee or Sponsor of the Investing Trust, other than any advisory fees paid to the Fund of Funds Adviser, trustee or Sponsor of an Investing Trust, or its affiliated person by the Self-Indexing Fund in connection with the investment by the Fund of Funds in the Self-Indexing Fund. Any Fund of Funds Sub-Adviser will waive fees otherwise payable to the Fund of Funds Sub-Adviser, directly or indirectly, by the Investing Management Company in an amount at least equal to any compensation received from a Self-Indexing Fund by the Fund of Funds Sub-Adviser, or an affiliated person of the Fund of Funds Sub-Adviser, other than any advisory fees paid to the Fund of Funds Sub-Adviser or its affiliated person by the Self-Indexing Fund in connection with the investment by the Investing Management Company in the Self-Indexing Fund made at the direction of the Fund of Funds Sub-Adviser. In the event that the Fund of Funds Sub-Adviser waives fees, the benefit of the waiver will be passed through to the Investing Management Company.
6. No Fund of Funds or Fund of Funds Affiliate (except to the extent it is acting in its capacity as an investment adviser to a Self-Indexing Fund) will cause a Self-Indexing Fund to purchase a security in any Affiliated Underwriting.
7. The Board of a Self-Indexing Fund, including a majority of the non-interested Board members, will adopt procedures reasonably designed to monitor any purchases of securities by the Self-Indexing Fund in an Affiliated Underwriting, once an investment by a Fund of Funds in the securities of the Self-Indexing Fund exceeds the limit of section 12(d)(1)(A)(i) of the Act, including any purchases made directly from an Underwriting Affiliate. The Board will review these purchases periodically, but no less frequently than annually, to determine whether the purchases were influenced by the investment by the Fund of Funds in the Self-Indexing Fund. The Board will consider, among other things: (i) Whether the purchases were consistent with the investment objectives and policies of the Self-Indexing Fund; (ii) how the performance of securities purchased in an Affiliated Underwriting compares to the performance of comparable securities purchased during a comparable period of time in underwritings other than Affiliated Underwritings or to a benchmark such as a comparable market index; and (iii) whether the amount of securities purchased by the Self-Indexing Fund in Affiliated Underwritings and the amount purchased directly from an Underwriting Affiliate have changed significantly from prior years. The Board will take any appropriate actions based on its review, including, if appropriate, the institution of procedures designed to ensure that purchases of securities in Affiliated Underwritings are in the best interest of shareholders of the Self-Indexing Fund.
8. Each Self-Indexing Fund will maintain and preserve permanently in
9. Before investing in a Self-Indexing Fund in excess of the limit in section 12(d)(1)(A), a Fund of Funds and the Trust will execute a FOF Participation Agreement stating without limitation that their respective boards of directors or trustees and their investment advisers, or trustee and Sponsor, as applicable, understand the terms and conditions of the order, and agree to fulfill their responsibilities under the order. At the time of its investment in Shares of a Self-Indexing Fund in excess of the limit in section 12(d)(1)(A)(i), a Fund of Funds will notify the Self-Indexing Fund of the investment. At such time, the Fund of Funds will also transmit to the Self-Indexing Fund a list of the names of each Fund of Funds Affiliate and Underwriting Affiliate. The Fund of Funds will notify the Self-Indexing Fund of any changes to the list of the names as soon as reasonably practicable after a change occurs. The Self-Indexing Fund and the Fund of Funds will maintain and preserve a copy of the order, the FOF Participation Agreement, and the list with any updated information for the duration of the investment and for a period of not less than six years thereafter, the first two years in an easily accessible place.
10. Before approving any advisory contract under section 15 of the Act, the board of directors or trustees of each Investing Management Company, including a majority of the disinterested directors or trustees, will find that the advisory fees charged under such contract are based on services provided that will be in addition to, rather than duplicative of, the services provided under the advisory contract(s) of any Self-Indexing Fund in which the Investing Management Company may invest. These findings and their basis will be fully recorded in the minute books of the appropriate Investing Management Company.
11. Any sales charges and/or service fees charged with respect to shares of a Fund of Funds will not exceed the limits applicable to a fund of funds as set forth in NASD Conduct Rule 2830.
12. No Self-Indexing Fund will acquire securities of an investment company or company relying on section 3(c)(1) or 3(c)(7) of the Act in excess of the limits contained in section 12(d)(1)(A) of the Act, except to the extent the Self-Indexing Fund acquires securities of another investment company pursuant to exemptive relief from the Commission permitting the Self-Indexing Fund to acquire securities of one or more investment companies for short-term cash management purposes.
For the Commission, by the Division of Investment Management, under delegated authority.
Pursuant to Section 19(b)(1)
The Exchange proposes to modify the Arca Options Deep market data product. The proposed rule change is available on the Exchange's Web site at
In its filing with the Commission, the self-regulatory organization included statements concerning the purpose of, and basis for, the proposed rule change and discussed any comments it received on the proposed rule change. The text of those statements may be examined at the places specified in Item IV below. The Exchange has prepared summaries, set forth in sections A, B, and C below, of the most significant parts of such statements.
The Exchange proposes to modify the Arca Options Deep market data product.
The Exchange currently offers the following real-time options market data feeds: “Arca Options Top,” “Arca Options Deep,” and “Arca Options Complex” (the “Arca Options Products”). “Arca Options Top” is a single market data product that combines last sale data, best bids and offers (“BBO”), order imbalance information and series status and underlying status messages (collectively called security status messages). “Arca Options Deep” is also a single market data product that provides subscribers NYSE Arca Options quotes and orders at the first three price levels in each series on a real-time basis. “Arca Options Complex,” also a single market data product, provides subscribers NYSE Arca Options quote and trade information (including orders/quotes, requests for responses, and trades) for the complex order book on a real-time basis.
The Exchange charges a single fee for Arca Options Top and subscribers of Arca Options Top receive all three data feeds described above. The Exchange charges a separate fee for Arca Options Complex for subscribers that seek to obtain this data feed on a standalone basis.
The Exchange proposes to modify the Arca Options Deep data feed. As proposed, Arca Options Deep will also include security status messages, the same data that is currently provided as part of Arca Options Top. The proposed modification to the Arca Options Deep data feed will allow subscribers who currently obtain depth of market data to also receive security status messages in a single data feed. Currently, these subscribers are required to process two data feeds to get the depth of market data and security status information. Offering a data product that combines, in one market data product, depth of market data and security status messages would provide greater efficiencies and better sequencing for vendors and subscribers that currently choose to integrate the data after receiving it from the Exchange. As with Arca Options Top, Arca Options Deep would provide depth of market and series status information on a real-time basis as reported to the Options Price Reporting Authority (“OPRA”) and disseminated on a consolidated basis under the OPRA Plan.
The Arca Options Products would continue to be distributed in their current format, to maintain the format of the Arca Options Products with that of other market data products offered by the Exchange.
The Exchange does not propose to make any changes to the fees. The single fee charged for the Arca Options Product that comprise [sic] the Arca Options Top, Arca Options Deep and Arca Options Complex would continue to apply. The separate fee that now applies to Arca Options Complex, would likewise continue to apply to the Arca Options Complex market data product.
Each of the Arca Options Products would continue to be offered through the Exchange's Liquidity Center Network (“LCN”), a local area network in the Exchange's Mahwah, New Jersey data center that is available to users of the Exchange's co-location services. The Exchange would also continue to offer the products through the Exchange's Secure Financial Transaction Infrastructure (“SFTI”) network, through which all other users and member organizations access the Exchange's trading and execution systems and other proprietary market data products.
The Exchange will announce the date that the Arca Options Deep market data product will begin to include security status messages through a NYSE Market Data Notice.
The proposed change is not intended to address any issues other than those described herein, and the Exchange is not aware of any problems that vendors or subscribers would have in complying with the proposed change.
The proposed rule change is consistent with Section 6(b)
The Exchange also believes this proposal is consistent with Section 6(b)(5) of the Act because it protects investors and the public interest and promotes just and equitable principles of trade by providing investors with improved options for receiving market data. The proposed rule changes would benefit investors by facilitating their prompt access to the additional real-time information contained in a modified Arca Options Deep market data product.
In particular, the Exchange believes that combining depth of market data with security status messages in the Arca Options Deep product is reasonable because it would provide greater efficiencies for vendors and subscribers that currently choose to integrate the data after receiving it from the Exchange. In addition, the change to the Arca Options Deep product reflects the interests and needs of subscribers and vendors who will no longer have to subscribe to multiple data feeds to obtain the information they want. The Exchange believes the proposed changes are reasonable because they would provide vendors and subscribers with higher quality market data products.
In adopting Regulation NMS, the Commission granted self-regulatory organizations and broker-dealers increased authority and flexibility to offer new and unique market data to consumers of such data. It was believed that this authority would expand the amount of data available to users and consumers of such data and also spur innovation and competition for the provision of market data. The Exchange believes that the options data product changes proposed herein are precisely the sort of market data product evolutions that the Commission envisioned when it adopted Regulation NMS. The Commission concluded that Regulation NMS—by lessening regulation of the market in proprietary data—would itself further the Act's goals of facilitating efficiency and competition:
[E]fficiency is promoted when broker-dealers who do not need the data beyond the prices, sizes, market center identifications of the NBBO and consolidated last sale information are not required to receive (and pay for) such data. The Commission also believes that efficiency is promoted when broker-dealers may choose to receive (and pay for) additional market data based on their own internal analysis of the need for such data.
By removing “unnecessary regulatory restrictions” on the ability of exchanges to sell their own data, Regulation NMS advanced the goals of the Act and the principles reflected in its legislative history.
The Exchange further notes that the existence of alternatives to the Exchange's products, including real-
The proposed options data products will help to protect a free and open market by providing additional data to the marketplace and give investors greater choices. In addition, the proposal would not permit unfair discrimination because the products will be available to all of the Exchange's customers and broker-dealers through both the LCN and SFTI.
In accordance with Section 6(b)(8) of the Act,
No written comments were solicited or received with respect to the proposed rule change.
The Exchange has filed the proposed rule change pursuant to Section 19(b)(3)(A)(iii) of the Act
A proposed rule change filed under Rule 19b-4(f)(6)
At any time within 60 days of the filing of such proposed rule change, the Commission summarily may temporarily suspend such rule change if it appears to the Commission that such action is necessary or appropriate in the public interest, for the protection of investors, or otherwise in furtherance of the purposes of the Act. If the Commission takes such action, the Commission shall institute proceedings under Section 19(b)(2)(B)
Interested persons are invited to submit written data, views, and arguments concerning the foregoing, including whether the proposed rule change is consistent with the Act. Comments may be submitted by any of the following methods:
• Use the Commission's Internet comment form (
• Send an email to
• Send paper comments in triplicate to Brent J. Fields, Secretary, Securities and Exchange Commission, 100 F Street NE., Washington, DC 20549-1090.
For the Commission, by the Division of Trading and Markets, pursuant to delegated authority.
The Options Clearing Corporation (“OCC”) is a clearing agency registered with the Securities and Exchange Commission (“Commission”) and is the only clearing agency for standardized U.S. options listed on U.S. national securities exchanges. Today, listed options are traded on twelve national securities exchanges: five national securities exchanges that are equal owners of OCC (“Stockholder Exchanges”)
OCC's role as the CCP for all listed options contracts in the U.S. makes it an integral part of the national system for clearance and settlement, and its failure or service disruption could have cumulative negative effects on the U.S. options and futures markets, financial institutions, and the broader financial system. As such, OCC was designated by the Financial Stability Oversight Council as a systemically important financial market utility (“SIFMU”) in 2012.
(available at
In the context of a number of developments in the financial markets, OCC's Board of Directors (“Board”) decided that OCC was significantly undercapitalized, and, in response, proposed and implemented an expedited plan to substantially increase OCC's capitalization (the “Capital Plan”), and, given OCC's critical clearing functions and its systemic importance, the Commission agrees that having OCC increase its capitalization is appropriate and in the public interest.
OCC filed the Capital Plan as an advance notice, SR-OCC-2014-813, under Section 806(e)(1) of the Payment, Clearing, and Settlement Supervision Act of 2010 (“Payment, Clearing and Settlement Supervision Act”)
The Delegated Order describes the elements of the proposed Capital Plan, OCC's financial condition, and the basis for OCC's projected capital requirement. The Delegated Order also discusses and responds to the comments received on the proposed Capital Plan. The Delegated Order makes findings that the Capital Plan is consistent with Exchange Act Sections 17A(b)(3)(A), 17A(b)(3)(F), 17A(b)(3)(D) and 17A(b)(3)(I).
In response to the Delegated Order, BATS, BOX, KCG, MIAX, and SIG (collectively “Petitioners”) filed notices of intention to petition for review of the Delegated Order, the first of which was filed on March 12, 2015.
The Commission issued two orders on September 10, 2015. The first order granted the Petitions for Review and scheduled the filing of statements either in support of or against the Delegated Order (“Review Order”).
The Commission's Rules of Practice set forth procedures for reviewing actions made pursuant to delegated authority. Pursuant to Rule 431(a) of the Rules of Practice, the Commission may affirm, reverse, modify, set aside or remand for further proceedings, in whole or in part, the action made pursuant to delegated authority.
In conducting its
OCC proposes to amend its rules to implement the Capital Plan.
OCC represents that it reviewed a range of risk scenarios and modeled potential losses arising from business, operational, and pension risks, and based on those results, it was appropriate to significantly increase its capital. After evaluating alternate sources of capital funding, including increasing fees or suspending refunds to clearing members, the Board approved the proposed Capital Plan.
Under the Capital Plan, OCC annually will determine a target capital requirement (“Target Capital Requirement”). To meet the initial Target Capital Requirement, the Stockholder Exchanges provided capital to OCC (“Capital Contribution”) and entered into an agreement (“Replenishment Capital Agreement”) to provide additional replenishment capital (“Replenishment Capital”) under certain circumstances. In return, the Stockholder Exchanges are eligible to receive dividends from OCC (“Dividend Policy”). Additionally, OCC will set its fees annually to cover its estimated operating expenses plus a “Business Risk Buffer” (“Fee Policy”). Finally, clearing members will be eligible to receive refunds annually, under certain circumstances (“Refund Policy”).
The Target Capital Requirement consists of: (i) A “Baseline Capital Requirement” plus (ii) a “Target Capital Buffer.” The Baseline Capital Requirement is equal to the greatest of: (i) Six months budgeted operating expenses for the following year; (ii) the maximum cost of the recovery scenario from OCC's recovery and wind-down plan; or (iii) the cost to OCC of winding down operations as set forth in its recovery and wind-down plan. The Target Capital Buffer is linked to plausible loss scenarios from business, operational, and pension risks and is designed to provide a significant capital cushion to offset potential business losses.
Under the Capital Plan, OCC requires the Stockholder Exchanges to provide a Capital Contribution pursuant to their Class B Common Stock on a
The Capital Contribution is supported by a Replenishment Capital Agreement, under which the Stockholder Exchanges have committed to provide Replenishment Capital if OCC's total shareholders' equity falls below a certain threshold. Specifically, if OCC's shareholders' equity falls below a “Hard Trigger” as described below, the Stockholder Exchanges are obligated to provide a committed amount of Replenishment Capital on a
As mentioned above, OCC has identified two triggers concerning the shareholders' equity that would require action by OCC: (i) A “Soft Trigger,” a warning sign that OCC's capitalization has fallen to a level that requires action to prevent it from falling to unacceptable levels, and (ii) a “Hard Trigger,” a sign that corrective action must be taken in the form of a mandatory Replenishment Capital call.
The Hard Trigger is reached when OCC's shareholders' equity falls below 125% of the Baseline Capital Requirement.
The Soft Trigger is reached when OCC's shareholders' equity falls below the sum of: (i) The Baseline Capital Requirement and (ii) 75% of the Target Capital Buffer.
In addition, the Board will review the Replenishment Capital Agreement on an annual basis. While the Replenishment Capital amount will increase as the Baseline Capital Requirement increases, if the Baseline Capital Requirement approaches or exceeds $200 million, the Board will review and revise the Capital Plan, as needed, to address potential future needs for Replenishment Capital higher than the $200 million cap. OCC also represents that its management will monitor OCC's shareholders' equity to identify additional triggers or reduced capital levels that may require action.
Under the Capital Plan, OCC will also implement a Fee Policy, Refund Policy, and Dividend Policy designed to maintain OCC's shareholders' equity above the Baseline Capital Requirement. Changes to the Fee Policy, Refund Policy, and Dividend Policy will require the affirmative vote of two-thirds of the directors then in office and unanimous approval by the holders of OCC's outstanding Class B Common Stock.
Under the Fee Policy, OCC will set fees at a level that will cover OCC's estimated operating expenses plus a “Business Risk Buffer.” According to OCC, the purpose of the Business Risk Buffer is to ensure that OCC accumulates sufficient funds to cover unexpected fluctuations in operating expenses, business capital needs, and regulatory capital requirements. Specifically, in setting fees each year, OCC will calculate an annual revenue target based on a forward twelve months expense forecast divided by the difference between one and the Business Risk Buffer of 25% (
OCC notes that the 25% Business Risk Buffer will be lower than OCC's historical 10-year average buffer of 31%. OCC represents that the lower buffer will permit it to charge lower fees to market participants, and thus become less reliant on refunds to clearing members to return any excess fees paid.
Under the Refund Policy, except at a time when Replenishment Capital is outstanding, OCC will declare a refund to clearing members in December of each year using the formula set out in the Refund Policy. Specifically, the refund will equal 50% of the excess of: (i) Pre-tax income for the year in which the refund is declared over (ii) the sum of the following: (x) The amount of pre-tax income after the refund necessary to produce after-tax income for such year sufficient to maintain shareholders' equity at the Target Capital Requirement for the following year, and (y) the amount of pre-tax income after the refund necessary to fund any additional reserves or additional surplus not already included in the Target Capital Requirement.
The Refund Policy states that OCC will declare refunds, if any, in December of each year, and such refunds would be paid in the following year after OCC issues its audited financial statements, provided that: (i) The payment does not result in a total shareholders' equity falling below the Target Capital Requirement and (ii) the payment is otherwise permitted by Delaware law, federal laws, and regulations.
OCC will not make refund payments while Replenishment Capital is outstanding and will resume refunds after the Replenishment Capital is repaid in full and the Target Capital Requirement is restored. However, OCC will not resume paying refunds and will recalculate how refunds are made if, for more than 24 months: (i) Replenishment Capital remains outstanding or (ii) the Target Capital Requirement is not restored.
Under the Dividend Policy, OCC will pay dividends to Stockholder Exchanges as consideration for their Capital Contribution and commitment to provide Replenishment Capital under the Replenishment Capital Agreement. OCC will declare dividends, if any, in December of each year, and such dividends would be paid in the following year after OCC issues its audited financial statements, provided that: (i) The payment does not result in total shareholders' equity falling below the Target Capital Requirement and (ii) the payment is otherwise permitted by Delaware law, federal laws, and regulations.
Pursuant to the Dividend Policy, except at a time when Replenishment Capital is outstanding, OCC will declare a dividend on its Class B Common Stock in December of each year in aggregate equal to the excess of: (i) After-tax income for the year, after application of the Refund Policy
Similar to the Refund Policy, if Replenishment Capital is outstanding, OCC will not pay dividends. OCC will resume dividends after the Replenishment Capital is repaid in full and the Target Capital Requirement is restored through the accumulation of retained earnings. However, OCC will not resume paying dividends and will recalculate how dividends are made if, for more than 24 months: (i) Replenishment Capital remains outstanding or (ii) the Target Capital Requirement is not restored. Moreover, the formulas for determining the refunds and dividends treat refunds as tax-deductible, and dividends are not tax-deductible. In the event that refunds are not tax-deductible, OCC represents that it will amend the Refund Policy and Dividend Policy to restore the relative economic benefits between the recipients of the refunds and the Stockholder Exchanges to what the Capital Plan currently provides.
Exchange Act Section 19(b)(2)(C) directs the Commission to approve a proposed rule change of a self-regulatory organization if it finds the change is consistent with the requirements of the Exchange Act and the rules and regulations thereunder applicable to such organization.
• Section 17A(b)(3)(F) of the Exchange Act requires, in part, that the rules of a registered clearing agency be designed to protect investors and the public interest.
• Section 17A(b)(3)(I) of the Exchange Act requires, in part, that the rules of a registered clearing agency do not impose any burden on competition not necessary or appropriate in furtherance of the purposes of the Exchange Act.
• Section 17A(b)(3)(D) of the Exchange Act requires, in part, that the rules of a registered clearing agency provide for the equitable allocation of reasonable dues, fees, and other charges among its participants.
• Section 17A(b)(3)(A) of the Exchange Act requires, in part, that a registered clearing agency be so organized and have the capacity to be able to facilitate the prompt and accurate clearance and settlement of securities transactions and to safeguard securities and funds in its custody or control or for which it is responsible.
• Section 3(f) of the Exchange Act requires, in part, that whenever pursuant to the Exchange Act the Commission is engaged in the review of a rule of a self-regulatory organization, and is required to consider or determine whether an action is necessary or appropriate in the public interest, the Commission must also consider, in addition to the protection of investors, whether the action will promote efficiency, competition, and capital formation.
The discussion below summarizes the comments received regarding OCC's proposed Capital Plan and provides OCC's responses and the Commission's evaluation of the proposal in accordance with the applicable Exchange Act requirements.
Commenters argue that the Capital Plan is inconsistent with Exchange Act Sections 17A(b)(3)(F) and 17A(b)(3)(I),
The Commission discusses each of these comments and OCC's responses below. After considering the entire record, and for reasons discussed below, the Commission finds that the Capital Plan is consistent with Exchange Act Sections 17A(b)(3)(F) and 17A(b)(3)(I).
Commenters argue that the Dividend Policy is inconsistent with Sections 17A(b)(3)(F) and 17A(b)(3)(I) of the Exchange Act,
OCC responds that the Dividend Policy is an integral part of the Capital Plan and is necessary to protect OCC against business, operational, and pension risks. OCC refutes the statement that the Capital Plan would turn OCC into a for-profit enterprise for the sole benefit of the Stockholder Exchanges.
Commenters also argue that the Capital Plan is inconsistent with Sections 17A(b)(3)(F) and 17A(b)(3)(I) of the Exchange Act
OCC refutes commenters' assertion that the Dividend Policy creates incentives for OCC to increase its operating expenses or its fees as a means to pay higher dividends to Stockholder Exchanges.
Commenters assert that the rate of return the Stockholder Exchanges will receive for providing the Capital Contribution and committing to provide Replenishment Capital under the Dividend Policy is excessive, and is therefore inconsistent with Sections 17A(b)(3)(F) and 17A(b)(3)(I) of the Exchange Act.
OCC responds that its status as the sole registered clearing agency in the options market does not mean that the Capital Contribution by the Stockholder Exchanges is a risk-free investment.
Commenters argue that the Capital Plan is inconsistent with 17A(b)(3)(I) of the Exchange Act
OCC counters that the Target Capital Requirement is the product of extensive analysis and takes into account a broad set of factors to cover plausible loss scenarios from business, operational, and pension risks.
OCC also disagrees that it has accumulated sufficient funds from clearing fees since the Capital Plan was proposed to render the Capital Plan unnecessary. OCC takes issue with commenters' calculations because, despite claiming the Capital Plan as being unnecessary, commenters included the contributions already made pursuant to the Plan in their calculations.
Finally, commenters argue that the Capital Plan is inconsistent with Section 17A(b)(3)(I) of the Exchange Act
OCC counters that the Board evaluated all viable and potential alternatives.
The Commission has considered the comments described above and finds that the Capital Plan is consistent with Exchange Act Section 17A(b)(3)(F).
After reviewing the Dividend Policy in conjunction with the other elements of the Capital Plan, the Commission does not believe that the Dividend Policy, or the Capital Plan as a whole, changes OCC's essential role as a market utility. Instead, the Capital Plan is designed to enhance OCC's capitalization rather than to enable the Stockholder Exchanges to monetize OCC's clearing monopoly. This enhanced capitalization is designed to allow OCC to continue its essential role by raising sufficient capital to cover business, operational, and pension risks. The Board determined that the historical practice of solely using fees, with annual refunds, to cover operating expenses and manage risks did not allow OCC to reach adequate capitalization.
The Commission does not believe that the Capital Plan operates to increase fees, inflate operating expenses or drive up transaction costs in a manner inconsistent with the protection of investors or the public interest. The Commission notes that commenters' arguments ignore that the Capital Plan incorporates a lower Business Risk Buffer, which allows generally lower fees.
For the reasons provided above, the Commission does not believe that the potential dividend rate, the Dividend Policy, or the Capital Plan, is inconsistent with investor protection or the public interest. On the contrary, the Capital Plan will support the critical functions and continued operations of OCC, particularly during times when its capital position is impaired, and is, therefore, consistent with the protection of investors and the public interest under Exchange Act Section 17A(b)(3)(F).
After considering the comments described above, the Commission finds that the Capital Plan does not impose any burden on competition not necessary or appropriate in furtherance of the purposes of the Act, and is therefore consistent with Exchange Act Section 17A(b)(3)(I).
The Commission notes that Exchange Act Section 17A(b)(3)(I)
The Commission has considered all the comments, OCC's responses and alternate plans for raising capital described by commenters. As an initial matter, the Commission does not believe that the Dividend Policy, or the Capital Plan as a whole, creates a subsidy that unfairly advantages Stockholder Exchanges. The Commission notes that any potential dividends declared under the Dividend Policy are intended to be consideration for the Stockholder Exchanges' contribution or commitment to capital and compensation for their opportunity cost and risk of loss associated with such contribution and commitment.
Similarly, the Commission does not believe that the Target Capital Requirement imposes a burden on competition not necessary or appropriate in furtherance of the purposes of the Exchange Act. The Commission notes that the Target Capital Requirement is designed to provide adequate capitalization, thereby substantially enhancing OCC's ability as a SIFMU to sustain non-default losses arising from business, operational, and pension risks. After reviewing the process used by OCC to establish the Target Capital Requirement, the Commission believes that the Target Capital Requirement is appropriately designed to capture identified and foreseeable business risks. OCC represents that it used various measures and took a methodical and reasoned approach to establish the Target Capital Requirement and the Commission does not believe that the Target Capital Requirement is or will be set at an unreasonable level.
Moreover, commenters have not explained how alternatives to the Dividend Policy or the Target Capital Requirement would be effective in promoting the significant interest under the Exchange Act in having a well-capitalized OCC to allow prompt clearance and settlement. A well-capitalized OCC provides support for
The Commission further notes that whether OCC would accumulate sufficient capital to reach the Target Capital Requirement through the accrual of fees was unknown at the time OCC proposed the Capital Plan. OCC's Board considered this alternative and determined that accumulation of clearing fees would take several years to achieve the Target Capital Requirement.
Finally, the existence of alternative ways for OCC to raise capital does not render the Capital Plan inconsistent with the Exchange Act. The Commission notes that the Board considered various alternative ways to raise capital and that the Board determined that the Capital Plan was in the best interests of OCC because it was designed to provide immediate access to capital through the Capital Contribution and was supported by the agreement to provide Replenishment Capital.
For reasons stated above, the Commission finds that the Capital Plan is consistent with Exchange Act Section 17A(b)(3)(I).
Commenters assert that the Capital Plan is inconsistent with Exchange Act Section 17A(b)(3)(D)
Commenters question whether the Board can fairly guide OCC on budget efficiencies in setting the fees.
As more fully discussed above, OCC counters that there is no unfair discrimination or inequitable allocation of fees because the parties' obligations are different, as only the Stockholder Exchanges face substantial risk of loss from their capital contributions, and commit to Replenishment Capital.
The Commission finds that the Capital Plan is consistent with Exchange Act Section 17A(b)(3)(D).
With respect to the reasonableness of fees, the Commission does not believe that the Capital Plan as a whole and the Fee Policy in particular, results in unreasonable dues, fees, and other charges. After setting its annual Target Capital Requirement, the Fee Policy requires OCC to set fees at levels to ensure that it can cover operational expenses, business and regulatory capital needs, and maintain shareholder equity. Reductions to, and the quarterly review of, the Business Risk Buffer will enable OCC to charge lower fees and make reductions as appropriate to manage revenue as close to its target as possible. These changes are designed to give market participants the benefit of lower upfront transaction costs,
In addition, any future fee change or increase will be subject to the rule filing requirements under Section 19(b) of the Exchange Act and Rule 19b-4 thereunder. The Commission believes that these filing requirements provide appropriate protection against future fee increases despite commenters' assertions to the contrary. The Exchange Act rule filing requirements for fee changes provide an opportunity for public comment
The Commission therefore, disagrees with commenters' assertions that the fee filings will not adequately protect investors against dues, fees, or other charges that are not reasonable.
For the reasons discussed above, the Commission finds that the Capital Plan is consistent with the Exchange Act Section 17A(b)(3)(D)
Section 17A(b)(3)(A) of the Exchange Act
OCC asserts that the Capital Plan is structured to provide OCC with sufficient capital (at a lower fee structure for market participants) to fund unpredictable business, operational, and pension events that might impair capital.
Taking these comments into account, the Commission finds that the Capital Plan is consistent with Exchange Act Section 17(A)(b)(3)(A). The Capital Plan supports OCC's business continuity (thereby facilitating the integrity of the clearing agency and its functions) by raising additional capital and obtaining a commitment from the Stockholder Exchanges to provide potential Replenishment Capital should it become necessary. In this manner, the Capital Plan ensures that OCC, especially during a significant event that impairs its capital, would have the capacity to facilitate and promote the prompt and accurate settlement of securities transactions and to safeguard securities and funds in its custody or control or for which it is responsible. Accordingly, the Commission finds that the Capital Plan is consistent with Exchange Act Section 17A(b)(3)(A).
Section 3(f) of the Exchange Act
The Commission has considered whether the Capital Plan promotes efficiency, competition, and capital formation, and discusses efficiency and capital formation below. The Commission has discussed the impact of the Capital Plan on competition in Section III.B.1 above.
With respect to the promotion of efficiency, the Commission first notes that under the Capital Plan, OCC has both immediate and ongoing access to cash to meet its Target Capital Requirement. From a timing standpoint, the Capital Plan is more immediate and expedient than several of the alternatives, such as raising capital from Non-Stockholder Exchanges, clearing members or third-parties, each of which would have necessitated governance changes over a period of time. Similarly, raising capital through the accumulation of fees was forecasted by OCC to take several years and would be subject to clearing volume volatility risks.
Second, the Capital Plan efficiently allocates costs for operational risk management among market participants. Having the Stockholder Exchanges bear the business, operational, and pension risks up front by making Capital Contributions and committing to Replenishment Capital in exchange for future dividend payments incents them, as owners of OCC, to prudently manage and minimize these risks, to avoid the loss of their capital contributions.
Third, on an ongoing basis, OCC intends to use clearing fees to maintain the Target Capital Requirement. This aspect of the Capital Plan apportions the costs of the Capital Plan to the clearing firms in relation to their clearing activity. Thus, the Capital Plan seeks to align the costs and benefits to clearing firms in accordance with their level of clearing activity. The Commission has
The Commission recognizes that, as commenters note, OCC will fund the cost of raising of capital by paying dividends, when eligible, to the Stockholder Exchanges. However, the Commission observes that other methods of raising capital similarly would incur costs to OCC and its participants. For example, raising capital through retained earnings involves costs related to applicable taxes as well as additional time to accumulate sufficient capital, during which time OCC will be exposed to business, operational and pension risks without sufficient capital to protect itself.
The Commission also has considered whether the Capital Plan promotes efficiency from the tax perspective. The Commission notes that similar tax consequences would exist if OCC had chosen to raise equity by issuing common stock or preferred stock to Non-Stockholder Exchanges, clearing members or third-party investors, because in each of these cases, OCC anticipates paying dividends to these parties in exchange for their investments, which will be subject to withholding tax prior to making dividend payments. Moreover, tax consequences are only one aspect of a consideration of efficiency in these circumstances.
The Commission also has considered whether the Capital Plan will promote capital formation. As discussed throughout this order, the Capital Plan is designed to enable OCC to withstand business, operational, and pension risks that may significantly affect OCC's ability to provide prompt clearance and settlement services. It also provides an incentive for OCC to prudently manage its risks by allocating these risks between Stockholder Exchanges and clearing participants. As OCC is the only clearing agency for listed standardized options in the U.S., it plays a crucial role in financial stability. A well-functioning equity options market provides an infrastructure necessary for trading both equity options and other equity investment products, which are used by companies and businesses to raise capital. The Commission believes that an adequately capitalized OCC should promote market confidence in OCC's ability to continuously serve the options market, which in turn facilitates prompt clearance and settlement of options transactions and promotes capital formation.
Commenters also raise certain procedural concerns with respect to the Capital Plan. Specifically, commenters argue that the process OCC underwent to approve the Capital Plan failed to comply with its own rules.
Section 19(g)(1) of the Exchange Act
Commenters argue that OCC failed to abide by Article XI of its By-Laws,
OCC responds that the Board was not prevented from approving the Capital Plan because of Board vacancies.
The Commission notes that the standard for approving a proposed rule change of a self-regulatory organization is that the proposed rule change is consistent with the requirements of the Exchange Act, and rules and regulations thereunder.
The Commission has delegated to the Director of the Division of Trading and Markets the authority to “publish notices of proposed rule changes filed by self-regulatory organizations and to approve such proposed rule changes.”
Commenters also argue that the Delegated Order failed to fulfill its obligation to engage in “reasoned decision-making,” or failed to examine the relevant data and articulate a satisfactory explanation for its action, including a rational connection between the facts found and the choice made.
As discussed above, shortly after the issuance of the Review Order and Stay Order, Petitioners filed the Reinstitution Motion on September 15, 2015, requesting that the Commission reinstitute the automatic stay.
On October 7, 2015, BATS, BOX, KCG, MIAX and SIG filed a motion (“Evidentiary Motion”) pursuant to Rule 452 of the Rules of Practice.
Additionally, one commenter filed a motion on October 7, 2015, requesting that the Commission order an oral argument pursuant to Rule 451
OCC filed a brief in opposition to the Evidentiary Motion on October 15, 2015, arguing that the commenters failed to demonstrate that the legal requirements for granting the motion are satisfied and prompt affirmance of the Capital Plan is necessary for OCC to be prudently capitalized at a level appropriate for a SIFMU.
The Commission received a reply memorandum in further support of the commenter's motion for oral argument on October 20, 2015.
The Commission has considered these motions, including OCC's oppositions and the movants' reply memoranda. For the reasons discussed below, these motions are denied.
Commenters filed the Reinstitution Motion, requesting that the Commission reinstitute the automatic stay on the ground that there is no compelling reason to implement the Capital Plan because OCC's current capital level is approaching the Target Capital Requirement and will soon exceed that amount and it would be extremely impracticable to reverse the implementation of the Capital Plan if the Delegated Order were subsequently reversed.
OCC responds that the Reinstitution Motion restated issues that had already been argued at length, considered and denied by the Commission and the Petitioners have not shown any manifest error, change in law or other recognized basis for the Commission to reconsider the Stay Order.
Because the Commission by this Order is engaging in a substantive review and approving the Capital Plan directly, the Reinstitution Motion and Expedition Motion are hereby moot.
Rule 452 governs the allowance of the submission of additional evidence.
In the Evidentiary Motion, the commenters request that the Commission: (i) Refer this matter to a hearing officer, and (ii) direct discovery in advance of the hearing.
Commenters rely on
Additionally, commenters question whether OCC's Board approval process operated in a manner consistent with the public interest and seeks additional evidence about that approval process.
Commenters also argue that OCC will effectively achieve its Target Capital Requirement within six months without implementing the Capital Plan.
OCC responds to these comments by noting that the commenters fail to meet
OCC states that, instead of identifying material evidence with particularity, commenters provided a sweeping list of discovery requests without an attempt to articulate why this information is material.
The Commission has determined that the information the Evidentiary Motion seeks to discover is not material to its review of the Capital Plan for purposes of determining whether the Capital Plan is consistent with the Exchange Act. The Evidentiary Motion requests information regarding: (i) Whether OCC considered less expensive alternatives to the Capital Plan; (ii) whether OCC's Board approval process was designed to serve the Stockholder Exchanges rather than the public interest; and (iii) whether OCC will achieve its Target Capital Requirement within six months without the Capital Plan's implementation. As discussed above, the existence of alternatives to the Capital Plan does not render the Capital Plan inconsistent with the Exchange Act, and the record fully establishes that OCC considered other alternatives to the Capital Plan. Additionally, the record indicates that OCC engaged in the required process to approve the Capital Plan, and questions regarding whether that process complied with relevant corporate governance principles are not appropriately addressed by the Commission in the context of reviewing this rule filing. Finally, the Commission notes that whether OCC would accumulate sufficient capital to reach the Target Capital Requirement was unknown at the time OCC proposed the Capital Plan and commenters' after-the-fact assertions about OCC capital levels include capital contributions made pursuant to the Capital Plan. The record also shows that the Capital Plan provides for the immediate infusion of capital and a commitment to provide Replenishment Capital, which OCC states could not be achieved in the same manner by other means.
The Commission has evaluated the record and, for reasons discussed above, finds that the Capital Plan is consistent with the Exchange Act requirements, and rules and regulations thereunder, applicable to OCC, and the Commission finds that the introduction of additional information is not necessary. Consequently, under Rule 452, the Commission denies the Evidentiary Motion.
Rule 451
A commenter states that an oral argument is proper under Rule 451.
The commenter further argues that OCC has failed to show the negative impact of an oral argument.
OCC responds that the commenter's motion does not satisfy the requirements of Rule 451, stating that the Commission has routinely denied oral argument when the issues raised can be determined by the record and papers filed by the parties.
Pursuant to the Rules of Practice, the Commission considers matters properly before it on the basis of the papers filed by the parties without oral argument unless it determines that the presentation of facts and legal arguments in the briefs and record and
It is therefore ordered that the earlier action taken by delegated authority, Securities Exchange Act Release No. 74452 (March 6, 2015), 80 FR 13058 (March 12, 2015) is set aside and pursuant to section 19(b)(2) of the Exchange Act SR-OCC-2015-02 is approved. All pending motions in this matter are hereby denied.
For the reasons stated above, it is hereby:
By the Commission.
Pursuant to Section 19(b)(1) of the Securities Exchange Act of 1934 (“Act”),
The Exchange is filing with the Commission a proposal to delete Rule 505 (Allocation, Reallocation and Transfer of Issues) and update Rule 506 (Allocation Application).
The text of the proposed rule change is available on the Exchange's Web site at
In its filing with the Commission, the Exchange included statements concerning the purpose of and basis for the proposed rule change and discussed any comments it received on the proposed rule change. The text of these statements may be examined at the places specified in Item IV below. The Exchange has prepared summaries, set forth in sections A, B, and C below, of the most significant aspects of such statements.
The Exchange proposes to update its rules to delete Rule 505 (Allocation, Reallocation and Transfer of Issues) and update Rule 506 (Allocation Application).
Rules 505 and 506 were approved more than three decades ago,
The Exchange has concluded that with the placement of certain concepts from Rule 505 into Rule 506, Rule 505 is no longer needed. The Exchange believes that it is desirable to discuss the process of allocation or reallocation application, allocation, reallocation, and transfer in one rule, namely Rule 506. Moreover, “leasing” is not practiced on the Exchange and obsolete language in Rule 505 in respect of leasing is no longer needed.
First, Rule 506 is updated to make it clear to the reader that the rule applies to the process of allocation application
Second, the Exchange is adding language to indicate that applications may be regarding reallocation. Section (b) of Rule 506 is expanded to state that an allocation or reallocation application shall be submitted to the Exchange's staff in writing. Each allocation or reallocation application will continue to include, at a minimum, the name and background of the head specialist and assistant specialist(s) (except that a Remote Specialist need not include an assistant specialist), the unit's experience and capitalization demonstrating an ability to trade the particular options class sought, and any other reasons why the unit believes it should be assigned or allocated the security.
Third, section (c) of Rule 506 states that allocation decisions and automatic allocations
Fourth, the Exchange is transferring the “Registrant” concept from deleted Rule 505 to section (d) of Rule 506 indicating in whose names an options class needs to be registered; and indicating that Registrant will act as specialist for a period of at least one year (known as “minimum specialist period”). Specifically, the Exchange proposes to add to section (d) the following language:
Upon allocation, reallocation, or transfer of an options class, the options class must be registered in either the name of the specialist unit, or jointly in the name of the unit and the specialist (“Registrant”). Each Registrant must be an Exchange member and an approved specialist. The Registrant shall act as specialist for the options class for at least one year (“minimum specialist period”); unless some other period is defined by the Exchange pursuant to this rule. After expiration of the minimum specialist period, the Exchange may re-allocate the options class.
In transferring the “Registrant” concept from deleted Rule 505, the Exchange does not state that the options class can be registered solely in the name of an individual acting as specialist since this is not the current practice. Rather, the Exchange proposes to state that the options class must be registered in either the name of the specialist unit, or jointly in the name of the unit and the specialist. Commensurate with other changes and the language of Rule 506, the Exchange is also proposing to state in Rule 506(d) that once the specialist unit is allocated, reallocated, or transferred an options class,
Fifth, the Exchange is transferring from Commentary .01 of deleted Rule 505 to new Commentary.03 of Rule 506 the concept that the Exchange may establish a period of less than one year for Registrant to act as a specialist in an options class (known as “alternate specialist period”). This allows the Exchange to establish a period of time that is less than one year, which is shorter than the minimum specialist period. During the alternate specialist period established by the Exchange the Registrant must act as specialist in an allocated options class. If the Exchange decides to establish an alternate specialist period, it will communicate such period in solicitation applications. Also, after the alternate or minimum specialist period the Exchange may re-allocate an options class. Specifically, the Exchange proposes to state in Commentary .03:
The Exchange may establish that a Registrant shall act as a specialist in an allocated options class for a shorter period defined by the Exchange that is less than one year (“alternate specialist period”). If the Exchange establishes an alternate specialist period, it will communicate such period in solicitation applications (notices) pursuant to Rule 506. After expiration of the alternate specialist period, the Exchange may re-allocate the options class.
The Exchange believes that these non-controversial changes to consolidate Rules 505 and 506 and to update and modernize Rule 506 as discussed will make remaining Rule 506 clearer and easier to use.
The Exchange believes that its proposal is consistent with Section 6(b) of the Act
The Exchange believes that the rule change will promote just and equitable principles of trade by making the rules clearer and easier to use. The Exchange is proposing to get rid of an older rule, specifically Rule 505, and to consolidate certain concepts from Rule 505 into remaining Rule 506. By doing so the Exchange is deleting obsolete language in Rule 505 regarding options classes that are subject to a lease, as leasing is not practiced on the Exchange. The Exchange is clarifying that Rule 506 will deal with allocation, reallocation, and transfer and that allocation, reallocation, or transfer decisions and automatic allocations will be communicated in writing to Exchange members. The Exchange proposes to transfer from deleted Rule 505 to Rule 506 the Registrant concept indicating that an options class must be registered in either the name of the specialist unit, or jointly in the name of the unit and the specialist; and indicating that Registrant will act as specialist for a one year minimum specialist period. The Exchange proposes to state in Rule 506 that the Exchange can establish an alternate specialist period that is shorter than the minimum specialist period, and that such alternate specialist period will be communicated in solicitation applications. The Exchange will also update language in Rule 506 for clarity and readability (
The Exchange believes that the proposed non-controversial change to consolidate Rules 505 and 506 and to
The Exchange does not believe that the proposed rule change will result in any burden on competition that is not necessary or appropriate in furtherance of the purposes of the Act, as amended. While the Exchange does not believe that the proposed non-controversial change is a burden on competition, or is competitive in nature, the Exchange believes that clearer, updated rules are always beneficial to market participants.
No written comments were either solicited or received.
The foregoing rule change has become effective pursuant to Section 19(b)(3)(A)
At any time within 60 days of the filing of the proposed rule change, the Commission summarily may temporarily suspend such rule change if it appears to the Commission that such action is: (i) Necessary or appropriate in the public interest; (ii) for the protection of investors; or (iii) otherwise in furtherance of the purposes of the Act. If the Commission takes such action, the Commission shall institute proceedings to determine whether the proposed rule should be approved or disapproved.
Interested persons are invited to submit written data, views, and arguments concerning the foregoing, including whether the proposed rule change is consistent with the Act. Comments may be submitted by any of the following methods:
• Use the Commission's Internet comment form (
• Send an email to
• Send paper comments in triplicate to Secretary, Securities and Exchange Commission, 100 F Street NE., Washington, DC 20549-1090.
For the Commission, by the Division of Trading and Markets, pursuant to delegated authority.
Pursuant to Section 19(b)(1)
The Exchange proposes to modify the Amex Options Deep market data product. The proposed rule change is available on the Exchange's Web site at
In its filing with the Commission, the self-regulatory organization included statements concerning the purpose of, and basis for, the proposed rule change and discussed any comments it received on the proposed rule change. The text of those statements may be examined at the places specified in Item IV below. The Exchange has prepared summaries, set forth in sections A, B, and C below, of the most significant parts of such statements.
The Exchange proposes to modify the Amex Options Deep market data product.
The Exchange currently offers the following real-time options market data feeds: “Amex Options Top,” “Amex Options Deep,” and “Amex Options Complex” (the “Amex Options Products”). “Amex Options Top” is a single market data product that combines last sale data, best bids and offers (“BBO”), order imbalance information and series status and underlying status messages (collectively called security status messages). “Amex Options Deep” is also a single market data product that provides subscribers NYSE Amex Options quotes and orders at the first three price levels in each series on a real-time basis. “Amex Options Complex,” also a single market data product, provides subscribers NYSE Amex Options quote and trade information (including orders/quotes, requests for responses, and trades) for the complex order book on a real-time basis.
The Exchange charges a single fee for Amex Options Top and subscribers of Amex Options Top receive all three data feeds described above. The Exchange charges a separate fee for Amex Options Complex for subscribers that seek to obtain this data feed on a standalone basis.
The Exchange proposes to modify the Amex Options Deep data feed. As proposed, Amex Options Deep will also include security status messages, the same data that is currently provided as part of Amex Options Top. The proposed modification to the Amex Options Deep data feed will allow subscribers who currently obtain depth of market data to also receive security status messages in a single data feed. Currently, these subscribers are required to process two data feeds to get the depth of market data and security status information. Offering a data product that combines, in one market data product, depth of market data and security status messages would provide greater efficiencies and better sequencing for vendors and subscribers that currently choose to integrate the data after receiving it from the Exchange. As with Amex Options Top, Amex Options Deep would provide depth of market and series status information on a real-time basis as reported to the Options Price Reporting Authority (“OPRA”) and disseminated on a consolidated basis under the OPRA Plan.
The Amex Options Products would continue to be distributed in their current format, to maintain the format of the Amex Options Products with that of other market data products offered by the Exchange.
The Exchange does not propose to make any changes to the fees. The single fee charged for the Amex Options Product that comprise [sic] the Amex Options Top, Amex Options Deep and Amex Options Complex would continue to apply. The separate fee that now applies to Amex Options Complex, would likewise continue to apply to the Amex Options Complex market data product.
Each of the Amex Options Products would continue to be offered through the Exchange's Liquidity Center Network (“LCN”), a local area network in the Exchange's Mahwah, New Jersey data center that is available to users of the Exchange's co-location services. The Exchange would also continue to offer the products through the Exchange's Secure Financial Transaction Infrastructure (“SFTI”) network, through which all other users and member organizations access the Exchange's trading and execution systems and other proprietary market data products.
The Exchange will announce the date that the Amex Options Deep market data product will begin to include security status messages through a NYSE Market Data Notice.
The proposed change is not intended to address any issues other than those described herein, and the Exchange is not aware of any problems that vendors or subscribers would have in complying with the proposed change.
The proposed rule change is consistent with Section 6(b)
The Exchange also believes this proposal is consistent with Section 6(b)(5) of the Act because it protects investors and the public interest and promotes just and equitable principles of trade by providing investors with improved options for receiving market data. The proposed rule changes would benefit investors by facilitating their prompt access to the additional real-time information contained in a modified Amex Options Deep market data product.
In particular, the Exchange believes that combining depth of market data with security status messages in the Amex Options Deep product is reasonable because it would provide greater efficiencies for vendors and subscribers that currently choose to integrate the data after receiving it from the Exchange. In addition, the change to the Amex Options Deep product reflects the interests and needs of subscribers and vendors who will no longer have to subscribe to multiple data feeds to obtain the information they want. The Exchange believes the proposed changes are reasonable because they would provide vendors and subscribers with higher quality market data products.
In adopting Regulation NMS, the Commission granted self-regulatory
[E]fficiency is promoted when broker-dealers who do not need the data beyond the prices, sizes, market center identifications of the NBBO and consolidated last sale information are not required to receive (and pay for) such data. The Commission also believes that efficiency is promoted when broker-dealers may choose to receive (and pay for) additional market data based on their own internal analysis of the need for such data.
By removing “unnecessary regulatory restrictions” on the ability of exchanges to sell their own data, Regulation NMS advanced the goals of the Act and the principles reflected in its legislative history.
The Exchange further notes that the existence of alternatives to the Exchange's products, including real-time consolidated data, free delayed consolidated data, and proprietary data from other sources, ensures that the Exchange is not unreasonably discriminatory because vendors and subscribers can elect these alternatives.
The proposed options data products will help to protect a free and open market by providing additional data to the marketplace and give investors greater choices. In addition, the proposal would not permit unfair discrimination because the products will be available to all of the Exchange's customers and broker-dealers through both the LCN and SFTI.
In accordance with Section 6(b)(8) of the Act,
No written comments were solicited or received with respect to the proposed rule change.
The Exchange has filed the proposed rule change pursuant to Section 19(b)(3)(A)(iii) of the Act
A proposed rule change filed under Rule 19b-4(f)(6)
At any time within 60 days of the filing of such proposed rule change, the Commission summarily may temporarily suspend such rule change if it appears to the Commission that such action is necessary or appropriate in the public interest, for the protection of investors, or otherwise in furtherance of the purposes of the Act. If the Commission takes such action, the Commission shall institute proceedings under Section 19(b)(2)(B)
Interested persons are invited to submit written data, views, and arguments concerning the foregoing, including whether the proposed rule change is consistent with the Act. Comments may be submitted by any of the following methods:
• Use the Commission's Internet comment form (
• Send an email to
• Send paper comments in triplicate to Brent J. Fields, Secretary, Securities and Exchange Commission, 100 F Street NE., Washington, DC 20549-1090.
For the Commission, by the Division of Trading and Markets, pursuant to delegated authority.
Pursuant to Section 19(b)(1)
The Exchange proposes to change the co-location services offered by the Exchange to include a means for co-located Users to receive the NASDAQ TotalView Ultra (FGPA) market data feed through a wireless connection. In addition, the proposed rule change reflects changes to the Exchange's Price List related to the proposed service. The proposed rule change is available on the Exchange's Web site at
In its filing with the Commission, the self-regulatory organization included statements concerning the purpose of, and basis for, the proposed rule change and discussed any comments it received on the proposed rule change. The text of those statements may be examined at the places specified in Item IV below. The Exchange has prepared summaries, set forth in sections A, B, and C below, of the most significant parts of such statements.
The Exchange proposes to change the co-location
The Commission has approved the Exchange's proposed rule change to provide a wireless connection to five market data feeds from third party markets.
As with the previously approved connectivity to Third Party Data through the wireless connection, the Exchange would utilize a network vendor to provide a wireless connection to TotalView Ultra through wireless connections from an Exchange access center to its data center in Mahwah, New Jersey, through a series of towers equipped with wireless equipment. To receive TotalView Ultra, the User would enter into a contract with NASDAQ, which would charge the User the applicable market data fees for TotalView Ultra. The Exchange would charge the User fees for the wireless connection to TotalView Ultra.
For each wireless connection to TotalView Ultra, a User would be charged a $5,000 non-recurring initial charge and a monthly recurring charge (“MRC”) of $11,000. The Exchange proposes to revise its Price List to reflect fees related to the connection to TotalView Ultra.
As with the previously approved wireless connections to Third Party Data, if a User purchased two wireless connections, it would pay two non-recurring initial charges, and the wireless connection would include the use of one port for connectivity to Third Party Data.
The Exchange proposes to offer the wireless connection to provide Users with an alternative means of connectivity to TotalView Ultra. Currently, Users can receive TotalView Ultra from wireless networks offered by third party vendors.
The wireless connection to the Third Party Data is expected to be available in January 2016, and no later than March 1, 2016. The Exchange will announce the date that the wireless connection to the Third Party Data will be available through a customer notice.
As is the case with all Exchange co-location arrangements, (i) neither a User nor any of the User's customers would be permitted to submit orders directly to the Exchange unless such User or customer is a member organization, a Sponsored Participant or an agent thereof (
The proposed change is not otherwise intended to address any other issues relating to co-location services and/or related fees, and the Exchange is not aware of any problems that Users would have in complying with the proposed change.
The Exchange believes that the proposed rule change is consistent with Section 6(b) of the Act,
The Exchange believes that the proposed service is not designed to permit unfair discrimination between customers, issuers, brokers, or dealers because the wireless connection to TotalView Ultra would provide Users with an alternative means of connectivity to TotalView Ultra. Users that do not opt to utilize the Exchange's proposed wireless connections would still be able to obtain TotalView Ultra through other methods, including, for example, from wireless networks offered by third party vendors, another User, through a telecommunications provider, or over the IP network. Users that opt to use wireless connections to TotalView Ultra would receive the TotalView Ultra that is available to all Users, as all market participants that contract with NASDAQ for TotalView Ultra may receive it.
The Exchange believes that this removes impediments to, and perfects the mechanisms of, a free and open market and a national market system and, in general, protects investors and the public interest because it would provide Users with choices with respect to the form and optimal latency of the connectivity they use to receive TotalView Ultra, allowing a User that opts to receive TotalView Ultra to select the connectivity and number of ports that better suit its needs, helping it tailor its data center operations to the requirements of its business operations.
The Exchange also believes that the proposed rule change is consistent with Section 6(b)(4) of the Act,
The Exchange believes that the proposed change is equitable and not unfairly discriminatory because it will result in fees being charged only to Users that voluntarily select to receive the corresponding services and because those services will be available to all Users. Furthermore, the Exchange believes that the services and fees proposed herein are not unfairly discriminatory and are equitably allocated because, in addition to the services being completely voluntary, they are available to all Users on an equal basis (
Overall, the Exchange believes that the proposed change is reasonable because the Exchange proposes to offer the wireless connection to TotalView Ultra described herein as a convenience to Users, but in doing so would incur certain costs, including costs related to the data center facility, hardware and equipment and costs related to personnel required for initial installation and monitoring, support and maintenance of such services. The costs associated with the wireless connections are incrementally higher than fiber optics-based solutions due to the expense of the wireless equipment, cost of installation and testing and ongoing maintenance of the network. The Exchange believes that it is reasonable that a User that has already purchased wireless connections to other Third Party Data would be charged a non-recurring charge when it purchases a wireless connection to TotalView Ultra, because the Exchange would incur certain costs in installing the wireless connection to TotalView Ultra irrespective of whether the User had existing wireless connections to Third Party Data. Such costs related to initial installation include, in particular, costs related to personnel required for initial installation and testing. The costs associated with installing wireless connections are incrementally higher than those associated with installing fiber optics-based solutions.
The Exchange believes that the proposed pricing for the wireless connection to TotalView Ultra is reasonable because it allows Users to select the TotalView Ultra connectivity option that better suits their needs. The fees also reflect the benefit received by Users in terms of lower latency over the fiber optics option. The Exchange believes that the proposed waiver of the first month's MRC is reasonable as it would allow Users to test the receipt of the feed for a month before incurring any monthly recurring fees and may act as an incentive to Users to connect to TotalView Ultra.
Moreover, the fees are equity [sic] allocated and not unfairly discriminatory because the wireless connection to TotalView Ultra would provide Users with an alternative means of connectivity to TotalView Ultra. Users that do not opt to utilize the Exchange's proposed wireless connections would still be able to obtain TotalView Ultra through other methods, including, for example, from wireless networks offered by third party vendors, another User, through a telecommunications provider, or over the IP network. Users that opt to use wireless connections to TotalView Ultra would receive the TotalView Ultra that is available to all Users, as all market participants that contract with NASDAQ for TotalView Ultra may receive it.
For the reasons above, the proposed changes do not unfairly discriminate between or among market participants that are otherwise capable of satisfying any applicable co-location fees, requirements, terms and conditions established from time to time by the Exchange.
Finally, the Exchange believes that it is subject to significant competitive forces, as described below in the Exchange's statement regarding the burden on competition.
For these reasons, the Exchange believes that the proposed fees are reasonable, equitable, and not unfairly discriminatory.
In accordance with Section 6(b)(8) of the Act,
The Exchange believes that allowing Users to receive TotalView Ultra through a wireless connection will not impose any burden on competition that is not necessary or appropriate in furtherance of the purposes of the Act because such access will satisfy User demand for additional options for connectivity to TotalView Ultra. Currently, Users can receive TotalView Ultra from wireless networks offered by third party vendors. Based on the information available to it, the Exchange believes that its proposed wireless connection would provide data at the same or similar speed and at the same or similar cost as the other wireless networks. Accordingly, the proposed wireless connection to TotalView Ultra would provide Users with an additional wireless connectivity option, thereby enhancing competition.
The Exchange notes that the proposed wireless connection to TotalView Ultra would compete not just with other wireless connections to TotalView Ultra, but also with fiber optic network connections to TotalView Ultra, which may be more attractive to some Users as they are more reliable and less susceptible to weather conditions. Users that do not opt to utilize wireless connections would be able to obtain TotalView Ultra through other methods, including, for example, from another User, through a telecommunications provider, or over the IP network. In this way, the proposed changes would enhance competition by helping Users tailor their connectivity to TotalView Ultra to the needs of their business operations by allowing them to select the form and optimal latency of the connectivity they use to receive TotalView Ultra that best suits their needs, helping them tailor their data center operations to the requirements of their business operations.
The proposed wireless connection to TotalView Ultra would traverse wireless connections through a series of towers equipped with wireless equipment, including a pole on the grounds of the data center. The proposed wireless network would have exclusive rights to operate wireless equipment on the data center pole. The Exchange will not sell rights to third parties to operate wireless equipment on the pole, due to space limitations, security concerns, and the interference that would arise between equipment placed too closely together. In addition to space issues, there are contractual restrictions on the use of the roof that the Exchange has determined would not be met if it offered space on the roof for third party wireless equipment. Moreover, access to the pole or roof is not required for third parties to establish wireless networks that can compete with the Exchange's proposed service, as witnessed by the existing wireless networks currently serving Users. Based on the information available to it, the Exchange believes that its proposed wireless connection to TotalView Ultra would provide data at the same or similar speed, and at the same or similar cost, as its proposed wireless connection [sic], thereby enhancing competition.
Finally, the Exchange notes that it operates in a highly competitive market in which market participants can readily favor competing venues if they deem fee levels at a particular venue to be excessive. In such an environment, the Exchange must continually review, and consider adjusting, its services and related fees and credits to remain competitive with other exchanges. For the reasons described above, the Exchange believes that the proposed rule change reflects this competitive environment.
No written comments were solicited or received with respect to the proposed rule change.
The Exchange has filed the proposed rule change pursuant to Section 19(b)(3)(A)(iii) of the Act
A proposed rule change filed under Rule 19b-4(f)(6)
At any time within 60 days of the filing of such proposed rule change, the Commission summarily may temporarily suspend such rule change if it appears to the Commission that such action is necessary or appropriate in the public interest, for the protection of investors, or otherwise in furtherance of the purposes of the Act. If the Commission takes such action, the Commission shall institute proceedings under Section 19(b)(2)(B)
Interested persons are invited to submit written data, views, and arguments concerning the foregoing, including whether the proposed rule change is consistent with the Act. Comments may be submitted by any of the following methods:
• Use the Commission's Internet comment form (
• Send an email to
• Send paper comments in triplicate to Secretary, Securities and Exchange Commission, 100 F Street NE., Washington, DC 20549-1090.
For the Commission, by the Division of Trading and Markets, pursuant to delegated authority.
Pursuant to Section 19(b)(1)
The Exchange proposes to change the co-location services offered by the Exchange to include a means for co-located Users to receive the NASDAQ TotalView Ultra (FGPA) market data feed through a wireless connection. In addition, the proposed rule change reflects changes to the NYSE MKT Equities Price List (“Price List”) and the NYSE Amex Options Fee Schedule (“Fee Schedule”) related to the proposed service. The proposed rule change is available on the Exchange's Web site at
In its filing with the Commission, the self-regulatory organization included statements concerning the purpose of, and basis for, the proposed rule change and discussed any comments it received on the proposed rule change. The text of those statements may be examined at the places specified in Item IV below. The Exchange has prepared summaries, set forth in sections A, B, and C below, of the most significant parts of such statements.
The Exchange proposes to change the co-location
The Commission has approved the Exchange's proposed rule change to provide a wireless connection to five market data feeds from third party markets.
As with the previously approved connectivity to Third Party Data through the wireless connection, the Exchange would utilize a network vendor to provide a wireless connection to TotalView Ultra through wireless connections from an Exchange access center to its data center in Mahwah, New Jersey, through a series of towers equipped with wireless equipment. To receive TotalView Ultra, the User would enter into a contract with NASDAQ, which would charge the User the applicable market data fees for TotalView Ultra. The Exchange would charge the User fees for the wireless connection to TotalView Ultra.
For each wireless connection to TotalView Ultra, a User would be charged a $5,000 non-recurring initial charge and a monthly recurring charge (“MRC”) of $11,000. The Exchange proposes to revise its Price List and Fee Schedule to reflect fees related to the connection to TotalView Ultra.
As with the previously approved wireless connections to Third Party Data, if a User purchased two wireless connections, it would pay two non-recurring initial charges, and the wireless connection would include the use of one port for connectivity to Third Party Data.
The Exchange proposes to offer the wireless connection to provide Users with an alternative means of connectivity to TotalView Ultra. Currently, Users can receive TotalView Ultra from wireless networks offered by third party vendors.
The wireless connection to the Third Party Data is expected to be available in January 2016, and no later than March 1, 2016. The Exchange will announce the date that the wireless connection to the Third Party Data will be available through a customer notice.
As is the case with all Exchange co-location arrangements, (i) neither a User nor any of the User's customers would be permitted to submit orders directly to the Exchange unless such User or customer is a member organization, a Sponsored Participant or an agent thereof (
The proposed change is not otherwise intended to address any other issues relating to co-location services and/or related fees, and the Exchange is not aware of any problems that Users would have in complying with the proposed change.
The Exchange believes that the proposed rule change is consistent with Section 6(b) of the Act,
The Exchange believes that the proposed service is not designed to permit unfair discrimination between customers, issuers, brokers, or dealers because the wireless connection to TotalView Ultra would provide Users with an alternative means of connectivity to TotalView Ultra. Users that do not opt to utilize the Exchange's proposed wireless connections would still be able to obtain TotalView Ultra through other methods, including, for example, from wireless networks offered by third party vendors, another User, through a telecommunications provider, or over the IP network. Users that opt to use wireless connections to TotalView Ultra would receive the TotalView Ultra that is available to all Users, as all market participants that contract with NASDAQ for TotalView Ultra may receive it.
The Exchange believes that this removes impediments to, and perfects the mechanisms of, a free and open market and a national market system and, in general, protects investors and the public interest because it would provide Users with choices with respect to the form and optimal latency of the connectivity they use to receive TotalView Ultra, allowing a User that opts to receive TotalView Ultra to select the connectivity and number of ports that better suit its needs, helping it tailor its data center operations to the requirements of its business operations.
The Exchange also believes that the proposed rule change is consistent with Section 6(b)(4) of the Act,
The Exchange believes that the proposed change is equitable and not unfairly discriminatory because it will result in fees being charged only to Users that voluntarily select to receive the corresponding services and because those services will be available to all Users. Furthermore, the Exchange believes that the services and fees proposed herein are not unfairly discriminatory and are equitably allocated because, in addition to the services being completely voluntary, they are available to all Users on an equal basis (
Overall, the Exchange believes that the proposed change is reasonable because the Exchange proposes to offer the wireless connection to TotalView Ultra described herein as a convenience to Users, but in doing so would incur certain costs, including costs related to the data center facility, hardware and equipment and costs related to personnel required for initial installation and monitoring, support and maintenance of such services. The costs associated with the wireless connections are incrementally higher than fiber optics-based solutions due to the expense of the wireless equipment, cost of installation and testing and ongoing maintenance of the network. The Exchange believes that it is reasonable that a User that has already purchased wireless connections to other Third Party Data would be charged a non-recurring charge when it purchases a wireless connection to TotalView Ultra, because the Exchange would incur certain costs in installing the wireless connection to TotalView Ultra irrespective of whether the User had existing wireless connections to Third Party Data. Such costs related to initial installation include, in particular, costs related to personnel required for initial installation and testing. The costs associated with installing wireless connections are incrementally higher than those associated with installing fiber optics-based solutions.
The Exchange believes that the proposed pricing for the wireless connection to TotalView Ultra is reasonable because it allows Users to select the TotalView Ultra connectivity option that better suits their needs. The fees also reflect the benefit received by Users in terms of lower latency over the fiber optics option. The Exchange believes that the proposed waiver of the first month's MRC is reasonable as it would allow Users to test the receipt of the feed for a month before incurring any monthly recurring fees and may act as an incentive to Users to connect to TotalView Ultra.
Moreover, the fees are equity [sic] allocated and not unfairly discriminatory because the wireless connection to TotalView Ultra would provide Users with an alternative means of connectivity to TotalView Ultra. Users that do not opt to utilize the Exchange's proposed wireless connections would still be able to obtain TotalView Ultra through other methods, including, for example, from wireless networks offered by third party vendors, another User, through a telecommunications provider, or over the IP network. Users that opt to use wireless connections to TotalView Ultra would receive the TotalView Ultra that is available to all Users, as all market participants that contract with NASDAQ for TotalView Ultra may receive it.
For the reasons above, the proposed changes do not unfairly discriminate between or among market participants that are otherwise capable of satisfying any applicable co-location fees, requirements, terms and conditions established from time to time by the Exchange.
Finally, the Exchange believes that it is subject to significant competitive forces, as described below in the Exchange's statement regarding the burden on competition.
For these reasons, the Exchange believes that the proposed fees are reasonable, equitable, and not unfairly discriminatory.
In accordance with Section 6(b)(8) of the Act,
The Exchange believes that allowing Users to receive TotalView Ultra through a wireless connection will not impose any burden on competition that is not necessary or appropriate in furtherance of the purposes of the Act because such access will satisfy User demand for additional options for connectivity to TotalView Ultra. Currently, Users can receive TotalView Ultra from wireless networks offered by third party vendors. Based on the information available to it, the Exchange believes that its proposed wireless connection would provide data at the same or similar speed and at the same or similar cost as the other wireless networks. Accordingly, the proposed wireless connection to TotalView Ultra would provide Users with an additional wireless connectivity option, thereby enhancing competition.
The Exchange notes that the proposed wireless connection to TotalView Ultra would compete not just with other wireless connections to TotalView Ultra, but also with fiber optic network connections to TotalView Ultra, which may be more attractive to some Users as they are more reliable and less susceptible to weather conditions. Users that do not opt to utilize wireless connections would be able to obtain TotalView Ultra through other methods, including, for example, from another User, through a telecommunications provider, or over the IP network. In this way, the proposed changes would enhance competition by helping Users tailor their connectivity to TotalView Ultra to the needs of their business operations by allowing them to select the form and optimal latency of the connectivity they use to receive TotalView Ultra that best suits their needs, helping them tailor their data center operations to the requirements of their business operations.
The proposed wireless connection to TotalView Ultra would traverse wireless connections through a series of towers equipped with wireless equipment, including a pole on the grounds of the data center. The proposed wireless network would have exclusive rights to operate wireless equipment on the data center pole. The Exchange will not sell rights to third parties to operate wireless equipment on the pole, due to space limitations, security concerns, and the interference that would arise between equipment placed too closely together. In addition to space issues, there are contractual restrictions on the use of the roof that the Exchange has determined would not be met if it offered space on the roof for third party wireless equipment. Moreover, access to the pole or roof is not required for third parties to establish wireless networks that can compete with the Exchange's proposed service, as witnessed by the existing wireless networks currently serving Users. Based on the information available to it, the Exchange believes
Finally, the Exchange notes that it operates in a highly competitive market in which market participants can readily favor competing venues if they deem fee levels at a particular venue to be excessive. In such an environment, the Exchange must continually review, and consider adjusting, its services and related fees and credits to remain competitive with other exchanges. For the reasons described above, the Exchange believes that the proposed rule change reflects this competitive environment.
No written comments were solicited or received with respect to the proposed rule change.
The Exchange has filed the proposed rule change pursuant to Section 19(b)(3)(A)(iii) of the Act
A proposed rule change filed under Rule 19b-4(f)(6)
At any time within 60 days of the filing of such proposed rule change, the Commission summarily may temporarily suspend such rule change if it appears to the Commission that such action is necessary or appropriate in the public interest, for the protection of investors, or otherwise in furtherance of the purposes of the Act. If the Commission takes such action, the Commission shall institute proceedings under Section 19(b)(2)(B)
Interested persons are invited to submit written data, views, and arguments concerning the foregoing, including whether the proposed rule change is consistent with the Act. Comments may be submitted by any of the following methods:
• Use the Commission's Internet comment form (
• Send an email to
• Send paper comments in triplicate to Secretary, Securities and Exchange Commission, 100 F Street NE., Washington, DC 20549-1090.
For the Commission, by the Division of Trading and Markets, pursuant to delegated authority.
Pursuant to Section 19(b)(1) of the Securities Exchange Act of 1934 (“Act”),
The Exchange proposes to amend Chapter XV, entitled “Options Pricing,” at Section 2, which governs pricing for Exchange members using the NASDAQ Options Market (“NOM”), the Exchange's facility for executing and routing standardized equity and index options.
While changes to the Pricing Schedule pursuant to this proposal are effective upon filing, the Exchange has designated these changes to be operative on February 1, 2016.
The text of the proposed rule change is available on the Exchange's Web site at
In its filing with the Commission, the Exchange included statements concerning the purpose of and basis for the proposed rule change and discussed any comments it received on the proposed rule change. The text of these statements may be examined at the places specified in Item IV below. The Exchange has prepared summaries, set forth in sections A, B, and C below, of the most significant aspects of such statements.
The Exchange proposes certain amendments to the NOM transaction fees set forth at Chapter XV, Section 2 for executing and routing standardized equity and index options under the Penny Pilot Options program. The Exchange desires to continue to offer an incentive to NOM Participants to add an even greater amount of liquidity to NOM. Specifically, the Exchange proposes to continue to incentivize Participants by continuing to offer the opportunity to reduce the NOM Market Maker
The Exchange is removing the current date range, January 11, 2016 through January 26 [sic], 2016, so the Exchange may continue to offer this incentive going forward. For purposes of clarity, the Exchange proposes to add rule text to make clear that Participants that add 1.30% of Customer, Professional, Firm, Broker-Dealer or Non-NOM Market Maker liquidity
The Exchange believes that the proposed rule change is consistent with Section 6 of the Act,
The Commission and the courts have repeatedly expressed their preference for competition over regulatory intervention in determining prices, products, and services in the securities markets. Further, “[n]o one disputes that competition for order flow is `fierce.' . . . As the SEC explained, `[i]n the U.S. national market system, buyers and sellers of securities, and the broker-dealers that act as their order-routing agents, have a wide range of choices of where to route orders for execution'; [and] `no exchange can afford to take its market share percentages for granted' because `no exchange possesses a monopoly, regulatory or otherwise, in the execution of order flow from broker dealers'. . . .”
The Exchange's proposal to continue to incentivize Participants to send order flow to NOM by offering the opportunity to reduce the NOM Market Maker and Non-NOM Market Maker Penny Pilot Options Fees for Removing Liquidity from $0.50 to $0.48 per contract, provided the Participant qualifies for the incentive,
The Exchange's proposal to continue to incentivize Participants to send order flow to NOM by offering the opportunity to reduce the NOM Market Maker and Non-NOM Market Maker Penny Pilot Options Fees for Removing Liquidity from $0.50 to $0.48 per contract, provided the Participant qualifies for the incentive,
The Exchange believes that it is reasonable, equitable and not unfairly discriminatory to only offer the fee reduction to NOM Market Makers and Non-NOM Market Makers because the Exchange is offering this $0.02 per contract fee discount to the Penny Pilot Options Fees for Removing Liquidity to continue to incentivize NOM Participants to select NOM as a venue to send Customer, Professional, Firm, Broker-Dealer or Non-NOM Market Maker order flow. Participants may send either Penny or Non-Penny Pilot Options to qualify for the discount.
The Exchange believes that it is reasonable, equitable and not unfairly discriminatory to permit NOM Participants with 75 percent common ownership to aggregate their volume for purposes of obtaining the fee discount because certain NOM Participants chose to segregate their businesses into different legal entities for purposes of conducting business. The Exchange believes that these NOM Participants should be treated as one entity for purposes of qualifying for the discounted Fee for Removing Liquidity in Penny Pilot Options, as long as there is at least 75% Common Ownership or control among the NOM Participants. The Exchange also believes that it is reasonable, equitable and not unfairly discriminatory to offer a $0.02 per contract reduced Penny Pilot Option Fee for Removing Liquidity to Non-NOM Market Makers and NOM Market Makers for transactions in which the same NOM Participant or a NOM Participant under Common Ownership is the buyer and the seller. NOM Participants that chose to segregate their businesses into different legal entities should still be afforded the opportunity to receive the discount as if they were the same NOM Participant on both sides of the transaction.
It is important to note that NOM Participants are unaware at the time the order is entered of the identity of the contra-party. Because contra-parties are anonymous, the Exchange believes that NOM Participants would aggressively pursue order flow in order to receive the benefit of the reduction. NOM Participants would only receive the incentive if they interact with their own order flow, recognizing Common Ownership where applicable. Offering the additional fee reduction is reasonable, equitable and not unfairly discriminatory because Participants would be entitled to receive the fee reduction only when the Participant is both the buyer and seller. By way of example, if a NOM Participant that is assigned the firm code
Finally, the Exchange's proposal to count all order flow (Penny and Non-Penny Pilot Options) toward the 1.30% requisite volume, except for NOM Market Maker order flow is reasonable, equitable and not unfairly discriminatory because NOM Market Makers are entitled to rebates today similar to Customers and Professionals. Customer volume is important because it continues to attract liquidity to the Exchange, which benefits all market participants. Further, with respect to Professional liquidity, the Exchange initially established Professional pricing in order to “. . . bring additional revenue to the Exchange.”
The Exchange does not believe that the proposed rule change will impose any burden on competition not necessary or appropriate in furtherance of the purposes of the Act. In terms of inter-market competition, the Exchange notes that it operates in a highly competitive market in which market participants can readily favor competing venues if they deem fee levels at a particular venue to be excessive, or rebate opportunities available at other venues to be more favorable. In such an environment, the Exchange must continually adjust its fees to remain competitive with other exchanges and with alternative trading systems that have been exempted from compliance with the statutory standards applicable to exchanges. Because competitors are free to modify their own fees in response and because market participants may readily adjust their order routing practices, the Exchange believes that the degree to which fee changes in this market may impose any burden on competition is extremely limited.
In this instance, the continuation of the proposed amendments to NOM Market Maker and Non-NOM Market Maker Penny Pilot Options Fees for Removing Liquidity do not impose an undue burden on inter-market competition because the Exchange's execution services are completely voluntary and subject to extensive competition.
The Exchange's proposal to incentivize Participants by continuing to offer the opportunity to reduce the NOM Market Maker and Non-NOM Market Maker Penny Pilot Options Fees for Removing Liquidity from $0.50 to $0.48 per contract, provided the Participant adds 1.30% of Customer, Professional, Firm, Broker-Dealer or Non-NOM Market Maker liquidity in Penny Pilot Options and/or Non-Penny Pilot Options of total industry customer equity and ETF option ADV contracts per day in a month
The Exchange believes that permitting NOM Participants with 75 percent common ownership to aggregate their volume for purposes of obtaining the fee discount does not create an undue burden on intra-market competition because certain NOM Participants chose to segregate their businesses into different legal entities for purposes of conducting business. NOM Participants that chose to segregate their businesses into different legal entities should still be afforded the opportunity to receive the discount as if they were the same NOM Participant on both sides of the transaction.
Participants would be entitled to receive the fee reduction when the Participant is both the buyer and seller and therefore this qualifier does not create an undue burden on intra-market competition. NOM Participants are unaware at the time the order is entered of the identity of the contra-party, therefore, since contra-parties are anonymous, the Exchange believes that NOM Participants would aggressively pursue order flow in order to receive the benefit of the reduction, to the benefit of all Participants.
The Exchange's proposal to continue to count all order flow toward the 1.30% requisite volume, except for NOM Market Maker order flow does not impose an undue burden on intra-market competition because the Exchange believes it is not necessary to count NOM Market Maker volume in qualifying for the fee discount as that volume is counted toward qualifying for NOM Market Maker rebates.
No written comments were either solicited or received.
The foregoing rule change has become effective pursuant to Section 19(b)(3)(A)(ii) of the Act.
At any time within 60 days of the filing of the proposed rule change, the Commission summarily may temporarily suspend such rule change if it appears to the Commission that such action is: (i) Necessary or appropriate in the public interest; (ii) for the protection of investors; or (iii) otherwise in furtherance of the purposes of the Act. If the Commission takes such action, the Commission shall institute proceedings to determine whether the proposed rule should be approved or disapproved.
Interested persons are invited to submit written data, views, and arguments concerning the foregoing, including whether the proposed rule change is consistent with the Act. Comments may be submitted by any of the following methods:
• Use the Commission's Internet comment form (
• Send an email to
• Send paper comments in triplicate to Brent J. Fields, Secretary, Securities and Exchange Commission, 100 F Street NE., Washington, DC 20549-1090.
For the Commission, by the Division of Trading and Markets, pursuant to delegated authority.
The Social Security Administration (SSA) publishes a list of information collection packages requiring clearance by the Office of Management and Budget (OMB) in compliance with Public Law 104-13, the Paperwork Reduction Act of 1995, effective October 1, 1995. This notice includes revisions of OMB-approved information collections.
SSA is soliciting comments on the accuracy of the agency's burden estimate; the need for the information; its practical utility; ways to enhance its quality, utility, and clarity; and ways to minimize burden on respondents, including the use of automated collection techniques or other forms of information technology. Mail, email, or fax your comments and recommendations on the information collection(s) to the OMB Desk Officer and SSA Reports Clearance Officer at the following addresses or fax numbers.
I. The information collections below are pending at SSA. SSA will submit them to OMB within 60 days from the date of this notice. To be sure we consider your comments, we must receive them no later than April 18, 2016. Individuals can obtain copies of the collection instruments by writing to the above email address.
1. Request to be Selected as a Payee—20 CFR 404.2010-404.2055, 416.601-416.665—0960-0014. SSA requires an individual applying to be a representative payee for a Social Security beneficiary or Supplemental Security Income (SSI) recipient to complete Form SSA-11-BK. SSA obtains information from applicant payees regarding their relationship to the beneficiary; personal qualifications; concern for the beneficiary's well-being; and intended use of benefits if appointed as payee. The respondents are individuals; private sector businesses and institutions; and State and local government institutions and agencies applying to become representative payees.
Type of Request: Revision of an OMB approved information collection.
2. Application for Benefits Under the Italy-U.S. International Social Security Agreement—20 CFR 404.1925—0960-0445. As per the November 1, 1978 agreement between the United States and Italian Social Security agencies, residents of Italy filing an application for U.S. Social Security benefits directly with one of the Italian Social Security agencies must complete Form SSA-2528. SSA uses Form SSA-2528 to establish age, relationship, citizenship, marriage, death, military service, or to evaluate a family bible or other family record when determining eligibility for benefits. The Italian Social Security agencies assist applicants in completing Form SSA-2528, and then forward the application to SSA for processing. The respondents are individuals living in Italy who wish to file for U.S. Social Security benefits.
Type of Request: Revision of an OMB-approved information collection.
3. Child Care Dropout Questionnaire—20 CFR 404.211(e)(4)—0960-0474. If individuals applying for Title II disability benefits care for their own or their spouse's children under age 3, and have no steady earnings during the time they care for those children, they may exclude that period of care from the disability computation period. We call this the child-care dropout exclusion. SSA uses the information from Form SSA-4162 to determine if an individual qualifies for this exclusion. Respondents are applicants for Title II disability benefits.
Type of Request: Revision of an OMB-approved information collection.
4. Certification of Contents of Document(s) or Record(s)—20 CFR 404.715—0960-0689. SSA established procedures for individuals to provide the evidence necessary to establish their rights to Social Security benefits. Examples of such evidence categories include age, relationship, citizenship, marriage, death, and military service. Form SSA-704 allows SSA employees; State record custodians; and other custodians of evidentiary documents to certify and record information from original documents and records under their custodial ownership to establish these types of evidence. SSA uses Form SSA-704 in situations where individuals cannot produce the original evidentiary documentation required to establish benefits eligibility. The respondents are State record custodians and other custodians of evidentiary documents.
Type of Request: Revision of an OMB-approved information collection.
5. Supplemental Security Income Wage Reporting (Telephone and Mobile)—20 CFR 416.701-732—0960-0715. SSA requires SSI recipients to report changes which could affect their eligibility for, and the amount of, their SSI payments, such as changes in income, resources, and living arrangements. SSA's SSI Telephone Wage Reporting (SSITWR) and SSI Mobile Wage Reporting (SSIMWR) enable SSI recipients to meet these requirements via an automated mechanism to report their monthly wages by telephone and mobile application, instead of contacting their local field offices. The SSITWR allows callers to report their wages by speaking their responses through voice recognition technology, or by keying in responses using a telephone key pad. The SSIMWR allows recipients to report their wages through the mobile wage reporting application on their
Type of Request: Revision of an OMB-approved information collection.
II. SSA submitted the information collections below to OMB for clearance. Your comments regarding the information collections would be most useful if OMB and SSA receive them 30 days from the date of this publication. To be sure we consider your comments, we must receive them no later than March 21, 2016. Individuals can obtain copies of the OMB clearance packages by writing to
1. Application for Widow's or Widower's Insurance Benefits—20 CFR 404.335-404.338, & 404.603—0960-0004. Section 2029(e) and 202(f) of the Social Security Act (Act) set forth the requirements for entitlement to widow(er)'s benefits, including the requirements to file an application. For SSA to make a formal determination for entitlement to widow(er)'s benefits, we use the Form SSA-10-BK to determine whether an applicant meets the statutory and regulatory conditions for entitlement to widow(er)'s Title II benefits. SSA employees interview individuals applying for benefits either face-to-face or via telephone and enter the information on the paper form or into the Modernized Claims System (MCS). The respondents are applicants for widow(er)'s benefits.
Type of Request: Revision of an OMB-approved information collection.
2. Employer Verification of Records for Children Under Age Seven—20 CFR 404.801-404.803, 404.821-404.822—0960-0505. SSA discovered as many as 70 percent of the wage reports we receive for children under age seven are actually the earnings of someone other than the child. To ensure we credit the correct person with the reported earnings, SSA verifies wage reports for children under age seven with the children's employers before posting to the earnings record. SSA uses Form SSA-L3231-C1, Request for Employer Information, for this purpose. The respondents are employers who report earnings for children under age seven.
Type of Request: Revision of an OMB-approved information collection.
3. Wage Reports and Pension Information—20 CFR 422.122(b)—0960-0547. Pension plan administrators annually file plan information with the Internal Revenue Service, which then forwards the information to SSA. SSA maintains and organizes this information by plan number, plan participant's name, and Social Security number. Under section 1131(a) of the Act, pension plan participants are entitled to request this information from SSA. The Wage Reports and Pension Information regulation, under 20 CFR 422.122(b) of the Code of Federal Regulations, stipulates that before SSA disseminates this information, the requestor must first submit a written request with identifying information to SSA. The respondents are requestors of pension plan information.
This is a correction notice: SSA published the incorrect burden, information for this collection at 80 FR 75484, on 12/2/15. We are correcting this error here.
Type of Request: Revision of an OMB-approved information collection.
The U.S. Advisory Commission on Public Diplomacy will hold a public meeting from 10:00 a.m. until 11:30 a.m., Tuesday, March 8, 2016 in Room 106 of the Dirksen Senate Office Building, at the corner of First Street and Constitution Ave. NE., Washington, DC 20002.
The meeting's topic will be “Reassessing Global Countering Violent Extremism Strategy” and will feature the head of the new Global Engagement Center at the U.S. Department of State. Other representatives from the State Department will be in attendance.
This meeting is open to the public, members and staff of Congress, the State Department, Defense Department, the media, and other governmental and non-governmental organizations. To attend and make any requests for reasonable accommodation, email
The United States Advisory Commission on Public Diplomacy appraises U.S. Government activities intended to understand, inform, and influence foreign publics. The Advisory Commission may conduct studies, inquiries, and meetings, as it deems necessary. It may assemble and disseminate information and issue reports and other publications, subject to the approval of the Chairperson, in consultation with the Executive Director. The Advisory Commission may undertake foreign travel in pursuit of its studies and coordinate, sponsor, or oversee projects, studies, events, or other activities that it deems desirable and necessary in fulfilling its functions.
The Commission consists of seven members appointed by the President, by and with the advice and consent of the Senate. The members of the Commission represent the public interest and are selected from a cross section of educational, communications, cultural, scientific, technical, public service, labor, business, and professional backgrounds. Not more than four members are from any one political party. The President designates a member to chair the Commission.
The current members of the Commission are: Mr. William Hybl of Colorado, Chairman; Ambassador Lyndon Olson of Texas, Vice Chairman; Mr. Sim Farar of California, Vice Chairman; Ambassador Penne Korth-Peacock of Texas; Ms. Lezlee Westine of Virginia; and Anne Terman Wedner of Illinois. One seat on the Commission is currently vacant.
To request further information about the meeting or the U.S. Advisory Commission on Public Diplomacy, you may contact its Executive Director, Katherine Brown, at
Department of State.
Further assignment of functions.
The Act specifically granted the President certain authorities and assigned the President certain functions related to agreements covered by the Act's provisions. In Executive Order No. 13701, the President assigned certain of these functions to the Secretary of State and provided guidance for performing those functions, including the further assignment of functions to officers of any other department or agency within the Executive Branch. This notice informs the public of the Secretary of State's further assignment of certain functions. This notice does not create any right or benefit, substantive or procedural, enforceable at law or equity by a party against the United States, its departments, agencies, instrumentalities or entities, its officers or employees, or any other person.
These actions were effective on the signature date.
Tiffany Prather,
Pursuant to section 1(c)(i) of Executive Order No. 13701, the Secretary of State hereby, as set forth below, further assigns certain functions of the Secretary of State under the Order. Departments and agencies shall carry out those functions in a manner that is supportive of agreements subject to the Act.
The functions of the President under section 102(c)(2) of the Act with respect to establishing consultative mechanisms assigned to the Secretary of State are further assigned to the United States Trade Representative, and shall be carried out jointly by the Secretary of State and the United States Trade Representative. Such consultative mechanisms are those established through trade agreements subject to the Act. This further assignment is without prejudice to the Secretary of State's responsibility for coordinating the operation of such mechanisms and obtaining the advice and assistance of any other agency as necessary and appropriate.
Surface Transportation Board.
Proposed Railroad Cost Recovery Procedures Productivity Adjustment.
In a decision served on February 12, 2016, we proposed to adopt 1.014 (1.4% per year) as the measure of average change in railroad productivity for the 2010-2014 (five-year) averaging period. This value represents an increase of 0.7% from the average for the 2009-2013 period. The Board's February 12, 2016 decision in this proceeding stated that comments may be filed addressing any perceived data and computational errors in the Board's calculation. It also stated that, if there were no further action taken by the Board, the proposed productivity adjustment would become effective on March 1, 2016.
The productivity adjustment is effective March 1, 2016. Comments are due by February 24, 2016.
Send comments (an original and 10 copies) referring to Docket No. EP 290 (Sub-No. 4) to: Surface Transportation Board, 395 E Street SW., Washington, DC 20423-0001.
Michael Smith, (202) 245-0322. Federal Information Relay Service (FIRS) for the hearing impaired, (800) 877-8339.
Additional information is contained in the Board's decision, which is available on our Web site at
By the Board, Chairman Elliott, Vice Chairman Miller, and Commissioner Begeman.
CSX Transportation, Inc. (CSXT), filed a verified notice of exemption under 49 CFR part 1152 subpart F—
CSXT has certified that: (1) No local traffic has moved over the Line for at least two years; (2) because the Line is not a through line, no overhead traffic has operated, and, therefore, none needs to be rerouted over other lines; (3) no formal complaint filed by a user of rail service on the Line (or by a state or local government entity acting on behalf of such user) regarding cessation of service over the Line is pending either with the Surface Transportation Board or any U.S. District Court or has been decided in favor of a complainant within the two-year period; and (4) the requirements at 49 CFR 1105.12 (newspaper publication) and 49 CFR 1152.50(d)(1) (notice to governmental agencies) have been met.
As a condition to this exemption, any employee adversely affected by the discontinuance of service shall be protected under
Provided no formal expression of intent to file an offer of financial assistance (OFA) to subsidize continued rail service has been received, this exemption will become effective on March 19, 2016, unless stayed pending reconsideration. Petitions to stay that do not involve environmental issues and formal expressions of intent to file an OFA to subsidize continued rail service under 49 CFR 1152.27(c)(2)
A copy of any petition filed with the Board should be sent to CSXT's representative: Louis E. Gitomer, Law Offices of Louis E. Gitomer, LLC, 600 Baltimore Avenue, Suite 301, Towson, MD 21204.
If the verified notice contains false or misleading information, the exemption is void ab initio.
Board decisions and notices are available on our Web site at “
By the Board, Rachel D. Campbell, Director, Office of Proceedings.
Federal Highway Administration (FHWA), DOT.
Notice of Limitation on Claims for Judicial Review of Actions by the California Department of Transportation (Caltrans), pursuant to 23 U.S.C. 327.
The FHWA, on behalf of Caltrans, is issuing this notice to announce actions taken by Caltrans that are final within the meaning of 23 U.S.C. 139(l)(1). The actions relate to a proposed highway project, Centennial Corridor Project on State Route 58 from Cottonwood Road to Interstate 5 and State Route 99 from Wilson Road to Gilmore Avenue in the County of Kern, State of California. Those actions grant licenses, permits, and approvals for the project.
By this notice, the FHWA, on behalf of Caltrans, is advising the public of final agency actions subject to U.S.C § 139(l)(1). A claim seeking judicial review of the Federal agency actions on the highway project will be barred unless the claim is filed on or before July 18, 2016. If the Federal law that authorizes judicial review of a claim provides a time period of less than 150 days for filing such claim, then that shorter time period still applies.
Jennifer H. Taylor, Office Chief, California Department of Transportation District 6, 855 M Street, Suite 200, Fresno, CA 93721, during normal business hours from 8:00 a.m. to 5:00 p.m., Telephone number (888) 404-6375, email:
Effective July 1, 2007, the FHWA assigned, and the Caltrans assumed environmental responsibilities for this project pursuant to 23 U.S.C. 327. Notice is hereby given that Caltrans has taken final agency
Caltrans, in cooperation with the City of Bakersfield, proposes to construct a freeway on a new alignment for State Route 58 and make improvements to the existing State Route 99. The new alignment for State Route 58 will provide a continuous route along State Route 58 from Cottonwood Road (post mile R55.6) on existing State Route 58 (East), east of State Route 99 to Interstate 5 (post mile T31.7). Improvements to State Route 99 from Wilson Road (post mile 21.2) to Gilmore Avenue (post mile 26.2) will also be required for the connection with State Route 58. The project is intended to provide route continuity and associated traffic congestion relief. The Federal ID number for the Centennial Corridor Project is NCIIP 5109 (106).
The actions by the Federal agencies, and the laws under which such actions were taken, are described in the Final Environmental Impact Statement (FEIS) for the project, approved on December 4, 2015, in the Record of Decision (ROD) issued on February 8, 2016, and in other documents in the FHWA project records. The FEIS, ROD and other project records are available by contacting Caltrans at the address provided above. The Caltrans FEIS and ROD can be viewed and downloaded from the project Web site at:
1. National Environmental Policy Act (NEPA) [42 U.S.C. 4321-4351]; Federal-Aid Highway Act [23 U.S.C. 109 and 23 U.S.C. 128].
2. Clean Air Act [42 U.S.C. 7401-7671(q)].
3. Section 4(f) of the U.S. Department of Transportation Act of 1966 [49 U.S.C. 303].
4. Endangered Species Act [16 U.S.C. 1531-1544 and Section 1536], Fish and Wildlife Coordination Act [16 U.S.C. 661-667(d)], Migratory Bird Treaty Act [16 U.S.C. 703-712].
5. Section 106 of the National Historic Preservation Act of 1966, as amended [16 U.S.C. 470(f)
6. Land and Water Conservation Fund (LWCF) [16 U.S.C. 4601-4604]; Clean Water Act 33 U.S.C. 1251-1387.
7. Farmland Protection Policy Act [7 U.S.C. 4201-4209 and its regulations].
8. E.O. 11990 Protection of Wetlands; E.O. 11988 Floodplain Management; E.O. 12898, Federal Actions to Address Environmental Justice in Minority Populations and Low Income Populations; E.O. 11593 Protection and Enhancement of Cultural Resources; E.O. 13112 Invasive Species.
23 U.S.C. 139(l)(1)
KEY DATES:
A.
B.
C.
D.
E.
A.
1.
The CDFI Fund reserves the right to award more or less than the amounts cited above in each category, based upon available funding and other factors, as appropriate.
2.
3.
B.
1.
2.
3.
C.
1.
FA and HFFI-FA award funds can be expended for activities in the following five categories: (i) Financial Products; (ii) Financial Services; (iii) Loan Loss Reserves; (iv) Development Services; and (v) Capital Reserves. FA awards can only be used for direct costs associated with an eligible activity; no indirect expenses are allowed. Up to 15 percent of the FA award can be used for Direct Administrative Expenses associated with an eligible FA activity. For purposes of this NOFA, the five eligible activity categories are defined as follows:
2.
TA grant funds can be expended for the following seven eligible activity categories: (i) Compensation—personal services; (ii) Compensation—fringe benefits; (iii) Professional Service Costs; (iv) Travel Costs; (v) Training and Education Costs; (vi) Equipment and other capital expenditures; and (vii) Supplies. Each of the eligible activity categories will not be authorized for indirect costs and an associated indirect cost rate. For purposes of this NOFA, the seven eligible activity categories are defined as follows:
A.
B.
A.
B.
All Applications must be prepared using the English language and calculations must be made in U.S. dollars. The following table lists the required Application documents for the FY 2016 Funding Round. The CDFI Fund reserves the right to request and review other pertinent or public information that has not been specifically requested in this NOFA or the Application. Information submitted by the Applicant that the CDFI Fund has not specifically requested will not be reviewed or considered as part of the Application. Information submitted must accurately reflect the Applicant's activities. Financial, portfolio, and activity information provided in the Application should only include the Applicant's activities.
C.
Applicants are encouraged to submit the SF-424 as early as possible through Grants.gov to provide time to resolve any submission problems. Applicants should contact Grants.gov directly with questions related to the registration or submission process as the CDFI Fund does not maintain the Grants.gov system.
The CDFI Fund strongly encourages Applicants to start the Grants.gov registration process as soon as possible (refer to the following link:
D.
E.
F.
1.
2.
(a) Grants.gov Submission Information: Each Applicant will receive an email from Grants.gov immediately after submitting the SF-424 confirming that the submission has entered the Grants.gov system. This email will contain a tracking number for the submitted SF-424. Within 48 hours, the Applicant will receive a second email, which will indicate if the submitted SF-424 was either successfully validated or rejected with errors. However, Applicants should not rely on the email notification from Grants.gov to confirm that their SF-424 was validated. Applicants are strongly encouraged to use the tracking number provided in the first email to closely monitor the status of their SF-424 by contacting the helpdesk at Grants.gov directly. The Application material submitted in AMIS is not officially accepted by the CDFI Fund until Grants.gov has validated the SF-424.
(b) Award Management Information System (AMIS) Submission Information: AMIS is a web-based portal where Applicants will directly enter their application information and add required attachments listed in Table 10. AMIS will verify that the Applicant provided the minimum information required to submit an Application. Applicants are responsible for the quality and accuracy of the information and attachments included in the Application submitted in AMIS. The CDFI Fund strongly encourages the Applicant to allow sufficient time to confirm the Application content, review the material submitted, and remedy any issues prior to the Application deadline. Only the Authorized Representative or the application Point of Contact can submit the Application. Applicants can only submit one Application. Upon submission, the Application will be locked and cannot be resubmitted, edited, or modified in any way. The CDFI Fund will not unlock or allow multiple Applications submissions.
4.
G.
1.
(a) An award Recipient shall use FA funds only for the eligible activities described in Section II. Award Description (C)(1) of this NOFA and its Assistance Agreement.
(b) A Recipient may not distribute FA funds to an Affiliate, Subsidiary, or any other entity, without the CDFI Fund's prior written approval.
(c) FA funds shall only be paid to the Recipient.
(d) The CDFI Fund, in its sole discretion, may pay FA funds in amounts, or under terms and conditions, which are different from those requested by an Applicant.
2.
(a) An award Recipient shall use HFFI-FA funds only for the eligible activities described in Section II. Award Description (C) (1) of this NOFA and its Assistance Agreement.
(b) A Recipient may not distribute HFFI-FA funds to an Affiliate, Subsidiary, or any other entity, without the CDFI Fund's prior written approval.
(c) HFFI-FA funds shall only be paid to the Recipient.
(d) The CDFI Fund, in its sole discretion, may pay HFFI-FA funds in amounts, or under terms and conditions, which are different from those requested by an Applicant.
3.
(a) An award Recipient shall use TA funds only for the eligible activities described in Section II. Award Description (C) (2) of this NOFA and its Assistance Agreement.
(b) A Recipient may not distribute TA funds to an Affiliate, Subsidiary or any other entity, without the CDFI Fund's prior written consent.
(c) TA funds shall only be paid to the Recipient.
(d) The CDFI Fund, in its sole discretion, may pay TA funds in amounts, or under terms and conditions, which are different from those requested by an Applicant.
1.
(a)
The CDFI Fund will score each part as indicated in Tables 12 and 13.
2.
TA Applications will be evaluated by one external reviewer; FA and HFFI-FA Applications will be evaluated by three external reviewers. All Applications will be reviewed in accordance with reviewer evaluation materials. Applications will be ranked based on Application scores, from highest to lowest. In the case of tied scores, Applicants will be ranked first according to each Performance score, then the Purpose section. TA Applicants, Category I, Category II, and HFFI-FA Applicants will be grouped and ranked separately.
3.
4.
5.
6.
7.
A.
B.
1.
2.
The CDFI Fund will minimize the time between the Recipient incurring costs for eligible activities and award payment based on what is administratively feasible. The advanced payments for eligible activities will occur no more than one year in advance of the Recipient incurring costs for the eligible activities. Following the initial closing, there may be subsequent closings involving additional award payments. Any documents in addition to the Assistant Agreement that are connected with such subsequent closings and payments shall be properly executed and timely delivered by the Recipient to the CDFI Fund.
3.
In addition, the CDFI Fund reserves the right, in its sole discretion, to terminate and rescind the Assistance Agreement and the award made under this NOFA pending the criteria described in the following table:
C.
1.
Each Recipient is responsible for the timely and complete submission of the Annual Reporting requirements. The CDFI Fund reserves the right to contact the Recipient and additional entities or signatories to the Assistance Agreement to request additional information and documentation. The CDFI Fund will use such information to monitor each Recipient's compliance with the requirements in the Assistance Agreement and to assess the impact of the CDFI Program. The CDFI Fund reserves the right, in its sole discretion, to modify these reporting requirements, including increasing the scope and frequency of reporting, if it determines it to be appropriate and necessary; however, such reporting requirements will be modified only after notice to Recipients.
2.
The cost principles used by Recipients must be consistent with Federal cost principles and support the accumulation of costs as required by the principles, and must provide for adequate documentation to support costs charged to the CDFI Program award. In addition, the CDFI Fund will require Recipients to: Maintain effective internal controls; comply with applicable statutes, regulations, and the Assistance Agreement; evaluate and monitor compliance; take action when not in compliance; and safeguard personally identifiable information.
A. The CDFI Fund will respond to questions concerning this NOFA and the Application between the hours of 9:00 a.m. and 5:00 p.m. Eastern Daylight Savings Time, starting on the date that the NOFA is published through the date listed in Table 1 and Table 11. The CDFI Fund will post on its Web site responses to reoccurring questions received about this Application. Other information regarding the CDFI Fund and its programs may be obtained from the CDFI Fund's Web site at
B.
C.
D.
A.
B.
12 U.S.C. 4701, et seq; 12 CFR parts 1805 and 1815; 2 CFR part 200.
KEY DATES:
A.
B.
C.
D.
E.
A.
1.
The CDFI Fund reserves the right to award more or less than the amounts cited above in each category, based upon available funding and other factors, as appropriate.
2.
3.
B.
1.
2.
3.
C.
1.
FA and HFFI-FA award funds can be expended for activities in the following five categories: (i) Financial Products; (ii) Financial Services; (iii) Loan Loss Reserves; (iv) Development Services; and (v) Capital Reserves. FA awards can only be used for direct costs associated with an eligible activity; no indirect expenses are allowed. Up to 15 percent of the FA award can be used for Direct Administrative Expenses associated with an eligible FA activity. For purposes of this NOFA, the five eligible activity categories are defined as follows:
2.
TA grant funds can be expended for the following seven eligible activity categories: (i) Compensation—personal services; (ii) Compensation—fringe benefits; (iii) Professional Service Costs; (iv) Travel Costs; (v) Training and Education Costs; (vi) Equipment and other capital expenditures; and (vii) Supplies. Each of the eligible activity categories will not be authorized for indirect costs and an associated indirect cost rate. For purposes of this NOFA, the seven eligible activity categories are defined as follows:
A.
B.
A.
B.
All Applications must be prepared using the English language and calculations must be made in U.S. dollars. The following table lists the required Application documents for the FY 2016 Funding Round. The CDFI Fund reserves the right to request and review other pertinent or public information that has not been specifically requested in this NOFA or the Application. Information submitted by the Applicant that the CDFI Fund has not specifically been requested will not be reviewed or considered as part of the Application. Information submitted must accurately reflect the Applicant's activities. Financial, portfolio, and activity information provided in the Application should only include the Applicant's activities.
C.
Applicants are only required to submit the OMB SF-424, Application for Federal Assistance form in Grants.gov as all other application information (listed in Table 10) will be submitted through AMIS. The deadline for submitting the SF 424 is 30 days after the publication of the NOFA. All other application information must be submitted in AMIS and only the Authorized Representative or Application Point of Contact can submit the application.
Applicants are encouraged to submit the SF-424 as early as possible through Grants.gov to provide time to resolve any submission problems. Applicants should contact Grants.gov directly with questions related to the registration or submission process as the CDFI Fund does not maintain the Grants.gov system.
The CDFI Fund strongly encourages Applicants to start the Grants.gov registration process as soon as possible (refer to the following link:
D.
E.
F.
1.
2.
(a) Grants. Gov. Submission Information: Each Applicant will receive an email from Grants.gov immediately after submitting the SF-424 confirming that the submission has entered the Grants.gov system. This email will contain a tracking number for the submitted SF-424. Within 48 hours, the Applicant will receive a second email, which will indicate if the submitted SF-424 was either successfully validated or rejected with errors. However, Applicants should not rely on the email notification from Grants.gov to confirm that their SF-424 was validated. Applicants are strongly encouraged to use the tracking number provided in the first email to closely monitor the status of their SF-424 by contacting the helpdesk at Grants.gov directly. The Application material submitted in AMIS is not officially accepted by the CDFI Fund until Grants.gov has validated the SF-424.
(b) Award Management Information System (AMIS) Submission Information: AMIS is a web-based portal where Applicants will directly enter their application information and add required attachments listed in Table 10. AMIS will verify that the Applicant provided the minimum information required to submit an Application. Applicants are responsible for the quality and accuracy of the information and attachments included in the Application submitted in AMIS. The CDFI Fund strongly encourages the Applicant to allow sufficient time to confirm the Application content, review the material submitted, and remedy any issues prior to the Application deadline. Only the Authorized Representative or the application Point of Contact can submit the Application. Applicants can only submit one Application. Upon submission, the Application will be locked and cannot be resubmitted, edited, or modified in any way. The CDFI Fund will not unlock or allow multiple Applications submissions.
3.
G.
1.
(a) An award Recipient shall use FA funds only for the eligible activities described in Section II. Award Description (C)(1) of this NOFA and its Assistance Agreement.
(b) A Recipient may not distribute FA funds to an Affiliate, Subsidiary, or any other entity, without the CDFI Fund's prior written approval.
(c) FA funds shall only be paid to the Recipient.
(d) The CDFI Fund, in its sole discretion, may pay FA funds in amounts, or under terms and conditions, which are different from those requested by an Applicant.
2.
(a) An award Recipient shall use HFFI-FA funds only for the eligible activities described in Section II. Award Description (C)(1) of this NOFA and its Assistance Agreement.
(b) A Recipient may not distribute HFFI-FA funds to an Affiliate, Subsidiary, or any other entity, without the CDFI Fund's prior written approval.
(c) HFFI-FA funds shall only be paid to the Recipient.
(d) The CDFI Fund, in its sole discretion, may pay HFFI-FA funds in amounts, or under terms and conditions, which are different from those requested by an Applicant.
3.
(a) An award Recipient shall use TA funds only for the eligible activities described in Section II. Award Description (C)(2) of this NOFA and its Assistance Agreement.
(b) A Sponsoring Entity award Recipient must create, as a legal entity, the Emerging CDFI no later than the end of the first year of the period of performance, whereupon the Sponsoring Entity must request the CDFI Fund to amend the Assistance Agreement and add the Emerging CDFI as a co-Recipient thereto, with the Sponsoring Entity, thereby transferring any and all remaining balances and/or
(c) A Recipient may not distribute TA funds to an Affiliate, Subsidiary or any other entity, without the CDFI Fund's prior written consent.
(d) TA funds shall only be paid to the Recipient.
(e) The CDFI Fund, in its sole discretion, may pay TA funds in amounts, or under terms and conditions, which are different from those requested by an Applicant.
1.
(a)
The CDFI Fund will score each part as indicated in Tables 12 and 13.
2.
TA Applications will be evaluated by one external reviewer; FA and HFFI-FA Applications will be evaluated by three external reviewers. All Applications will be reviewed in accordance with reviewer evaluation materials. Applications will be ranked based on Application scores, from highest to lowest. In the case of tied scores, Applicants will be ranked first according to each Performance score, then the Purpose section. TA Applicants, FA Applicants, and HFFI-FA Applicants will be grouped and ranked separately.
3.
4.
5.
6.
7.
A.
B.
1.
2.
The CDFI Fund will minimize the time between the Recipient incurring costs for eligible activities and award payment based on what is administratively feasible. The advanced payments for eligible activities will occur no more than one year in advance of the Recipient incurring costs for the eligible activities. Following the initial closing, there may be subsequent closings involving additional award payments. Any documents in addition to the Assistant Agreement that are connected with such subsequent closings and payments shall be properly executed and timely delivered by the Recipient to the CDFI Fund.
3.
In addition, the CDFI Fund reserves the right, in its sole discretion, to
C.
1.
Each Recipient is responsible for the timely and complete submission of the Annual Reporting requirements. Sponsoring Entities with co-awardees will be informed of any reporting shifts at the time the Emerging CDFI is adjoined to the Agreement. The CDFI Fund reserves the right to contact the Recipient and additional entities or signatories to the Assistance Agreement to request additional information and documentation. The CDFI Fund will use such information to monitor each Recipient's compliance with the requirements in the Assistance Agreement and to assess the impact of the NACA Program. The CDFI Fund reserves the right, in its sole discretion, to modify these reporting requirements, including increasing the scope and frequency of reporting, if it determines it to be appropriate and necessary; however, such reporting requirements will be modified only after notice to Recipients.
2.
The cost principles used by Recipients must be consistent with Federal cost principles and support the accumulation of costs as required by the principles, and must provide for adequate documentation to support costs charged to the NACA Program award. In addition, the CDFI Fund will require Recipients to: Maintain effective internal controls; comply with applicable statutes, regulations, and the Assistance Agreement; evaluate and monitor compliance; take action when not in compliance; and safeguard personally identifiable information.
A. The CDFI Fund will respond to questions concerning this NOFA and the Application between the hours of 9:00 a.m. and 5:00 p.m. Eastern Daylight Savings Time, starting on the date that the NOFA is published through the date listed in Table 1 and Table 11. The CDFI Fund will post on its Web site responses to reoccurring questions received about this Application. Other information regarding the CDFI Fund and its programs may be obtained from the CDFI Fund's Web site at
B.
C.
D.
A.
B.
12 U.S.C. 4701, et seq; 12 CFR parts 1805 and 1815; 2 CFR part 200.
Internal Revenue Service, Treasury.
Notice of Renewal of the Art Advisory Panel of the Commissioner of Internal Revenue.
The charter for the Art Advisory Panel has been renewed for a two-year period beginning February 3, 2016.
Maricarmen R. Cuello, C:AP:SO:ART, 51 SW 1st Avenue, Miami, FL 33130, Telephone No. (305) 982-5364 (not a toll free number).
Notice is hereby given under section 10(a)(2) of the Federal Advisory Committee Act (5 U.S.C. App. 2), that the Art Advisory Panel of the Commissioner of Internal Revenue, a necessary committee that is in the public interest, has been renewed for an additional two years beginning on February 3, 2016.
The Panel helps the Internal Revenue Service review and evaluate the acceptability of property appraisals submitted by taxpayers in support of the fair market value claimed on works of art involved in Federal Income, Estate or Gift taxes in accordance with sections 170, 2031, and 2512 of the Internal Revenue Code of 1986.
For the Panel to perform this function, Panel records and discussions must include tax return information. Therefore, the Panel meetings will be closed to the public since all portions of the meetings will concern matters that are exempted from disclosure under the provisions of section 552b(c)(3), (4), (6) and (7) of Title 5 of the U.S. Code. This determination, which is in accordance with section 10(d) of the Federal Advisory Committee Act, is necessary to protect the confidentiality of tax returns and return information as required by section 6103 of the Internal Revenue Code.
U.S.-China Economic and Security Review Commission.
Notice of open public hearing—February 24, 2016, Washington, DC.
Notice is hereby given of the following hearing of the U.S.-China Economic and Security Review Commission.
Any member of the public seeking further information concerning the hearing should contact Anthony DeMarino, 444 North Capitol Street NW., Suite 602, Washington, DC 20001; phone: 202-624-1496, or via email at
Congress created the U.S.-China Economic and Security Review Commission in 2000 in the National Defense
Veterans Benefits Administration, Department of Veterans Affairs.
Notice.
In compliance with the Paperwork Reduction Act (PRA) of 1995 (44 U.S.C. 3501-3521), this notice announces that the Veterans Benefits Administration (VBA), Department of Veterans Affairs, will submit the collection of information abstracted below to the Office of Management and Budget (OMB) for review and comment. The PRA submission describes the nature of the information collection and its expected cost and burden; it includes the actual data collection instrument.
Comments must be submitted on or before March 21, 2016.
Submit written comments on the collection of information through
Crystal Rennie, Enterprise Records Service (005R1B), Department of Veterans Affairs, 810 Vermont Avenue NW., Washington, DC 20420, (202) 632-7492 or email
An agency may not conduct or sponsor, and a person is not required to respond to a collection of information unless it displays a currently valid OMB control number. The
By direction of the Secretary,
Office of Small and Disadvantaged Business Utilization (OSDBU), The Department of Veterans Affairs (VA).
Notice.
VA OSDBU, is announcing an opportunity for public comment on the proposed collection of certain information by the agency. Under the Paperwork Reduction Act (PRA) of 1995, Federal agencies are required to publish notice in the
Written comments and recommendations on the proposed collection of information should be received on or before April 18, 2016.
Submit written comments on the collection of information through Federal Docket Management System (FDMS) at
Milagros Ortiz, (202) 461-4279 or
Under the PRA of 1995 (Pub. L. 104-13; 44 U.S.C. 3501-3521), Federal agencies must obtain approval from the Office of Management and Budget (OMB) for each collection of information they conduct or sponsor. This request for comment is being made pursuant to Section 3506(c)(2)(A) of the PRA.
With respect to the following collection of information, OMB invites comments on: (1) Whether the proposed collection of information is necessary for the proper performance of OMB's functions, including whether the information will have practical utility; (2) the accuracy of OMB's estimate of the burden of the proposed collection of information; (3) ways to enhance the quality, utility, and clarity of the information to be collected; and (4) ways to minimize the burden of the collection of information on respondents, including through the use of automated collection techniques or the use of other forms of information technology.
By direction of the Secretary.
Veterans Benefits Administration, Department of Veterans Affairs.
Notice; comment request.
The Veterans Benefits Administration (VBA), Department of Veterans Affairs (VA), is announcing an opportunity for public comment on the proposed collection of certain information by the agency. Under the Paperwork Reduction Act (PRA) of 1995, Federal agencies are required to publish notice in the
The holder of a vendee account which has been guaranteed by the Department of Veterans Affairs (VA) may request VA to repurchase a loan as provided in 38 CFR 36.
Written comments and recommendations on the proposed collection of information should be received on or before April 18, 2016.
Submit written comments on the collection of information through Federal Docket Management System (FDMS) at
Nancy J. Kessinger at (202) 632-8924 or FAX (202) 632-8925.
Under the PRA of 1995 (Pub. L. 104-13; 44 U.S.C. 3501-21), Federal agencies must obtain approval from the Office of Management and Budget (OMB) for each collection of information they conduct or sponsor. This request for comment is being made pursuant to Section 3506(c)(2)(A) of the PRA.
With respect to the following collection of information, VBA invites comments on: (1) Whether the proposed collection of information is necessary for the proper performance of VBA's functions, including whether the information will have practical utility; (2) the accuracy of VBA's estimate of the burden of the proposed collection of information; (3) ways to enhance the quality, utility, and clarity of the information to be collected; and (4) ways to minimize the burden of the collection of information on respondents, including through the use of automated collection techniques or the use of other forms of information technology.
By direction of the Secretary.
Veterans Health Administration, Department of Veterans Affairs.
Notice.
The Veterans Health Administration (VHA) is announcing an opportunity for public comment on the proposed collection of certain information by the agency. Under the Paperwork Reduction Act (PRA) of 1995, Federal agencies are required to publish notice in the
Written comments and recommendations on the proposed collection of information should be received on or before April 18, 2016.
Submit written comments on the collection of information through the Federal Docket Management System (FDMS) at
Brian McCarthy at (202) 461-6345.
Under the PRA of 1995 (Pub. L. 104-13; 44 U.S.C. 3501-3521), Federal agencies must obtain approval from OMB for each collection of information they conduct
With respect to the following collection of information, VHA invites comments on: (1) Whether the proposed collection of information is necessary for the proper performance of VHA's functions, including whether the information will have practical utility; (2) the accuracy of VHA's estimate of the burden of the proposed collection of information; (3) ways to enhance the quality, utility, and clarity of the information to be collected; and (4) ways to minimize the burden of the collection of information on respondents, including through the use of automated collection techniques or the use of other forms of information technology.
1. VA Form 10-10d, Application for CHAMPVA Benefits, is used to determine eligibility of persons applying for healthcare benefits under the CHAMPVA program in accordance with 38 U.S.C. 501 and 1781.
2. VA Form 10-7959a, CHAMPVA Claim Form, is used to adjudicate claims for CHAMPVA benefits in accordance with 38 U.S.C. 501 and 1781, and 10 U.S.C. 1079 and 1086. This information is required for accurate adjudication and processing of beneficiary submitted claims. The claim form is also instrumental in the detection and prosecution of fraud. In addition, the claim form is the only mechanism to obtain, on an interim basis, other health insurance (OHI) information.
3. Except for Medicaid and health insurance policies that are purchased exclusively for the purpose of supplementing CHAMPVA benefits, CHAMPVA is always the secondary payer of healthcare benefits (38 U.S.C. 501 and 1781, and 10 U.S.C. 1086). VA Form 10-7959c, CHAMPVA—Other Health Insurance (OHI) Certification, is used to systematically obtain OHI information and to correctly coordinate benefits among all liable parties.
4. The Federal Medical Care Recovery Act (42 U.S.C. 2651-2653), mandates recovery of costs associated with healthcare services related to an injury/illness caused by a third party. VA Form 10-7959d, CHAMPVA Potential Liability Claim, provides basic information from which potential liability can be assessed. Additional authority includes 38 U.S.C. 501; 38 CFR 1.900
5. VA Form 10-7959e, VA Claim for Miscellaneous Expenses, information collection is needed to carry out the health care programs for certain children of Korea and/or Vietnam veterans authorized under 38 U.S.C., chapter 18, as amended by section 401, P.L. 106-419 and section 102, P.L. 108-183. VA's medical regulations 38 CFR part 17 (17.900 through 17.905) establish regulations regarding provision of health care for certain children of Korea and Vietnam veterans and women Vietnam veterans' children born with spina bifida and certain other covered birth defects. These regulations also specify the information to be included in requests for preauthorization and claims from approved health care providers.
6. Payment of Claims for Provision of Health Care for Certain Children of Korea and/or Vietnam Veterans (includes provider billing and VA Forms 10-7959e). This data collection is for the purpose of claiming payment/reimbursement of expenses related to spina bifida and certain covered birth defects. Beneficiaries utilize VA Form 10-7959e, VA Claim for Miscellaneous Expenses. Providers utilize provider generated billing statements and standard billing forms such as: Uniform Billing-Forms UB-04, and CMS 1500, Medicare Health Insurance Claims Form. VA would be unable to determine the correct amount to reimburse providers for their services or beneficiaries for covered expenses without the requested information. The information is instrumental in the timely and accurate processing of provider and beneficiary claims for reimbursement. The frequency of submissions is not determined by VA, but will determined by the provider or claimant and will be based on the volume of medical services and supplies provided to patients and claims for reimbursement are submitted individually or in batches.
7. Review and Appeal Process Regarding Provision of Health Care or Payment Relating to Provision of Health Care for Certain Children of Korea and/or Vietnam Veterans. The provisions of 38 CFR 17.904 establish a review process regarding disagreements by an eligible veteran's child or representative with a determination concerning provision of health care or a health care provider's disagreement with a determination regarding payment. The person or entity requesting reconsideration of such determination is required to submit such a request to the Chief Business Office Purchased Care (CBOPC) (Attention: Chief, Customer Service), in writing within one year of the date of initial determination. The request must state why the decision is in error and include any new and relevant information not previously considered. After reviewing the matter, a Customer Service Advisor issues a written determination to the person or entity seeking reconsideration. If such person or entity remains dissatisfied with the determination, the person or entity is permitted to submit within 90 days of the date of the decision a written request for review by the Director, CBOPC.
1. VA Form 10-10d—4,411 hours.
2. VA Form 10-7959a—37,336 hours.
3. VA Form 10-7959c—13,456 hours.
4. VA Form 10-7959d—467 hours.
5. VA Form 10-7959e—200 hours.
6. Payment (beneficially claims)—500 hours.
7. Review and Appeal Process—200 hours.
1. VA Form 10-10d—10 minutes.
2. VA Form 10-7959a—10 minutes.
3. VA Form 10-7959c—10 minutes.
4. VA Form 10-7959d—7 minutes.
5. VA Form 10-7959e—15 minutes.
6. Payment (beneficially claims)—10 minutes.
7. Review and Appeal Process—20 minutes.
1. VA Form 10-10d—26,468.
2. VA Form 10-7959a—224,018.
3. VA Form 10-7959c—80,733.
4. VA Form 10-7959d—4,000.
5. VA Form 10-7959e—800.
6. Payment (beneficially claims)—3,000.
7. Review and Appeal Process—600.
By direction of the Secretary.
Veterans Benefits Administration, Department of Veterans Affairs.
Notice.
In compliance with the Paperwork Reduction Act (PRA) of 1995 (44 U.S.C. 3501-3521), this notice announces that the Veterans Benefits Administration (VBA), Department of Veterans Affairs, will submit the collection of information abstracted below to the Office of Management and Budget (OMB) for review and comment. The PRA submission describes the nature of the information collection and its expected cost and burden; it includes the actual data collection instrument.
Comments must be submitted on or before March 21, 2016.
Submit written comments on the collection of information through
Crystal Rennie, Enterprise Records Service (005R1B), Department of Veterans Affairs, 810 Vermont Avenue NW., Washington, DC 20420, (202) 632-7492 or email
An agency may not conduct or sponsor, and a person is not required to respond to a collection of information unless it displays a currently valid OMB control number.
The
By direction of the Secretary.
Category | Regulatory Information | |
Collection | Federal Register | |
sudoc Class | AE 2.7: GS 4.107: AE 2.106: | |
Publisher | Office of the Federal Register, National Archives and Records Administration |