Page Range | 26347-26546 | |
FR Document |
Page and Subject | |
---|---|
83 FR 26456 - Public Water System Supervision Program Revision for the State of Nevada | |
83 FR 26497 - Government in the Sunshine Act Meeting Notice | |
83 FR 26457 - Sunshine Act Meeting; Farm Credit Administration Board | |
83 FR 26533 - Delmarva Central Railroad Company-Change in Operator Exemption-Cassatt Management, LLC d/b/a Bay Coast Railroad | |
83 FR 26463 - Formations of, Acquisitions by, and Mergers of Bank Holding Companies | |
83 FR 26367 - Safety Zone; Blazing Paddles 2018 SUP Race; Cuyahoga River, Cleveland, OH & | |
83 FR 26538 - Agency Information Collection Activities: Requests for Comments Approval of Information Collection: Organization Designation Authorization | |
83 FR 26537 - Agency Information Collection Activities: Requests for Comments; Clearance of Renewed Approval of Information Collection: Dealer's Aircraft Registration Certificate Application | |
83 FR 26369 - Acequinocyl; Pesticide Tolerances | |
83 FR 26537 - Agency Information Collection Activities: Requests for Comments; Clearance of Reinstate Approval of Information Collection: Aviation Insurance | |
83 FR 26438 - Applications for New Awards; Gaining Early Awareness and Readiness for Undergraduate Programs (Partnership Grants) | |
83 FR 26539 - Notice of Public Meeting: National Dialogue on Highway Automation | |
83 FR 26445 - Applications for New Awards; Gaining Early Awareness and Readiness for Undergraduate Programs (State Grants) | |
83 FR 26499 - Agency Information Collection Activities: Proposed Collection; Comments Requested; Request for Registration Under the Gambling Devices Act of 1962 | |
83 FR 26432 - Pacific Fishery Management Council; Public Meeting | |
83 FR 26490 - Certificate of Alternative Compliance for the M/V SAMANTHA S | |
83 FR 26364 - Drawbridge Operation Regulation; Hutchinson River, New York, NY | |
83 FR 26496 - Agency Information Collection Activities: Homeland Security Acquisition Regulation (HSAR) Regulation on Agency Protests | |
83 FR 26365 - Drawbridge Operation Regulation; Snohomish River and Steamboat Slough, Everett and Marysville, WA | |
83 FR 26365 - Safety Zone; Ohio River, Mile Marker 27.8 to Mile Marker 28.2, Vanport, PA | |
83 FR 26364 - Drawbridge Operation Regulation; Willamette River at Portland, OR | |
83 FR 26361 - Special Local Regulation; Tred Avon River, Between Bellevue, MD and Oxford, MD | |
83 FR 26458 - Information Collection Being Submitted for Review and Approval to the Office of Management and Budget | |
83 FR 26436 - Agency Information Collection Activities: Notice of Intent To Renew Collection 3038-0093, Part 40, Provisions Common to Registered Entities | |
83 FR 26437 - Agency Information Collection Activities: Notice of Intent To Renew Collection Number 3038-0007, Regulation of Domestic Exchange-Traded Options | |
83 FR 26503 - Draft Letter to the Nuclear Energy Institute Regarding the Clarification of Regulatory Paths for Lead Test Assemblies | |
83 FR 26432 - Schedules for Atlantic Shark Identification Workshops and Safe Handling, Release, and Identification Workshops | |
83 FR 26359 - Removal of Cross References to Previously Removed Appendices and Subpart | |
83 FR 26489 - End of the Call for Participation for Computational Photography Project for Pill Identification (C3PI) | |
83 FR 26415 - Glycine From India, the People's Republic of China, and Thailand: Postponement of Preliminary Determinations of Countervailing Duty Investigations | |
83 FR 26414 - Certain Folding Gift Boxes From the People's Republic of China: Final Results of Expedited Third Sunset Review and Continuation of the Antidumping Duty Order | |
83 FR 26503 - Advisory Committee on the Medical Uses of Isotopes: Meeting Notice | |
83 FR 26347 - Securities Transaction Settlement Cycle | |
83 FR 26413 - Agenda and Notice of Public Meetings of the South Dakota Advisory Committee | |
83 FR 26457 - Notice of Issuance of Statement of Federal Financial Accounting Standards 55, Amending Inter-Entity Cost Provisions | |
83 FR 26452 - Application To Export Electric Energy; ALLETE, Inc., d/b/a Minnesota Power | |
83 FR 26452 - Certification Notice-253; Notice of Filing of Self-Certification of Coal Capability Under the Powerplant and Industrial Fuel Use Act | |
83 FR 26453 - Notice of Intent To Grant an Exclusive Copyright License | |
83 FR 26434 - Multistakeholder Process on Promoting Software Component Transparency | |
83 FR 26354 - Regulatory Program Fees and Water Charges Rates | |
83 FR 26377 - Hours of Service of Drivers of Commercial Motor Vehicles: Regulatory Guidance Concerning the Use of a Commercial Motor Vehicle for Personal Conveyance | |
83 FR 26505 - Product Change-Priority Mail Negotiated Service Agreement | |
83 FR 26505 - Product Change-Priority Mail Express Negotiated Service Agreement | |
83 FR 26464 - Proposed Data Collection Submitted for Public Comment and Recommendations | |
83 FR 26374 - Hours of Service of Drivers of Commercial Motor Vehicles; Regulatory Guidance Concerning the Transportation of Agricultural Commodities | |
83 FR 26501 - Pacific Gas and Electric Company Diablo Canyon Independent Spent Fuel Storage Installation | |
83 FR 26491 - Changes in Flood Hazard Determinations | |
83 FR 26495 - Ohio; Amendment No. 1 to Notice of a Major Disaster Declaration | |
83 FR 26494 - Proposed Flood Hazard Determinations | |
83 FR 26453 - Stoneray Power Partners, LLC; Supplemental Notice That Initial Market-Based Rate Filing Includes Request for Blanket Section 204 Authorization | |
83 FR 26454 - Copenhagen Wind Farm, LLC; Supplemental Notice That Initial Market-Based Rate Filing Includes Request for Blanket Section 204 Authorization | |
83 FR 26456 - Montauk Energy Storage Center, LLC; Supplemental Notice That Initial Market-Based Rate Filing Includes Request for Blanket Section 204 Authorization | |
83 FR 26454 - East Hampton Energy Storage Center, LLC; Supplemental Notice That Initial Market-Based Rate Filing Includes Request for Blanket Section 204 Authorization | |
83 FR 26454 - Combined Notice of Filings #1 | |
83 FR 26541 - Pipeline Safety: Information Collection Activities | |
83 FR 26541 - Limitation on Claims Against Proposed Public Transportation Projects | |
83 FR 26361 - Air Force Freedom of Information Act Program | |
83 FR 26534 - Cumberland Fossil Plant Coal Combustion Residuals Management Operations Final Environmental Impact Statement | |
83 FR 26539 - Notice of Final Federal Agency Actions on Proposed Highway in California | |
83 FR 26485 - Facilitation of Public-Private Dialogue to Increase Innovation and Investment in the Healthcare Sector | |
83 FR 26499 - Notice of Intent To Grant Partially Exclusive License | |
83 FR 26500 - Notice of Intent To Grant Partially Exclusive Patent License | |
83 FR 26387 - Airworthiness Directives; Airbus Helicopters Deutschland GmbH Helicopters | |
83 FR 26483 - Pulmonary-Allergy Drugs Advisory Committee; Notice of Meeting; Establishment of a Public Docket; Request for Comments | |
83 FR 26416 - Takes of Marine Mammals Incidental to Specified Activities; Taking Marine Mammals Incidental to Marine Site Characterization Surveys off of Delaware | |
83 FR 26540 - Petition for Waiver of Compliance | |
83 FR 26482 - Requests for Feedback and Meetings for Medical Device Submissions: The Q-Submission Program; Draft Guidance for Industry and Food and Drug Administration Staff; Availability | |
83 FR 26465 - Food and Drug Administration Modernization Act of 1997: Modifications to the List of Recognized Standards, Recognition List Number: 049 | |
83 FR 26477 - Agency Information Collection Activities; Proposed Collection; Comment Request; Environmental Impact Considerations | |
83 FR 26481 - Sebela Ireland, Ltd. et al.; Withdrawal of Approval of 24 Abbreviated New Drug Applications; Correction | |
83 FR 26481 - Advisory Committee; Pulmonary-Allergy Drugs Advisory Committee, Renewal | |
83 FR 26356 - Listing of Color Additives Subject to Certification; D&C Black No. 4 | |
83 FR 26475 - Prescription Drug User Fee Act Waivers for Fixed-Combination Antiretroviral Drugs for the President's Emergency Plan for AIDS Relief; Draft Guidance for Industry; Availability | |
83 FR 26477 - Agency Information Collection Activities; Submission for Office of Management and Budget Review; Comment Request; Record Retention Requirements for the Soy Protein and Risk of Coronary Heart Disease Health Claim | |
83 FR 26497 - Agency Information Collection Activities; Proposed eCollection eComments Requested; Federal Explosives License/Permit (FEL) Renewal Application-ATF Form 5400.14/5400.15 Part III | |
83 FR 26498 - Agency Information Collection Activities; Proposed eCollection eComments Requested; Revision of a Currently Approved Collection; Firearms Disabilities for Nonimmigrant Aliens | |
83 FR 26413 - Agenda and Notice of Public Meeting of the Massachusetts Advisory Committee | |
83 FR 26546 - Open Meeting of the Taxpayer Advocacy Panel Taxpayer Communications Project Committee | |
83 FR 26544 - Open Meeting of the Taxpayer Advocacy Panel Special Projects Committee | |
83 FR 26546 - Open Meeting of the Taxpayer Advocacy Panel Joint Committee | |
83 FR 26498 - Notice Pursuant to the National Cooperative Research and Production Act of 1993-DVD Copy Control Association | |
83 FR 26546 - Open Meeting of the Taxpayer Advocacy Panel Taxpayer Assistance Center Improvements Project Committee | |
83 FR 26544 - Electronic Tax Administration Advisory Committee (ETAAC); Notice of Meeting | |
83 FR 26499 - Notice Pursuant to the National Cooperative Research and Production Act of 1993-Heterogeneous System Architecture Foundation | |
83 FR 26545 - Open Meeting of the Taxpayer Advocacy Panel Tax Forms and Publications Project Committee | |
83 FR 26545 - Open Meeting of the Taxpayer Advocacy Panel Notices and Correspondence Project Committee | |
83 FR 26545 - Open Meeting of the Taxpayer Advocacy Panel Toll-Free Phone Line Project Committee | |
83 FR 26392 - Product Jurisdiction; Correction | |
83 FR 26392 - Periodic Reporting | |
83 FR 26412 - Notice of Public Meeting of the Idaho Advisory Committee | |
83 FR 26416 - Marine Fisheries Advisory Committee; Charter Renewal | |
83 FR 26416 - Marine Fisheries Advisory Committee Meeting | |
83 FR 26531 - Self-Regulatory Organizations; Cboe BZX Exchange, Inc.; Notice of Filing and Immediate Effectiveness of a Proposed Rule Change to Amend a Representation Made in a Proposed Rule Change Previously Approved by the Commission Relating to the Listing and Trading of the iShares Inflation Hedged Corporate Bond ETF | |
83 FR 26514 - Self-Regulatory Organizations; Fixed Income Clearing Corporation; Notice of Filing of Amendment No. 1 and Order Granting Accelerated Approval of a Proposed Rule Change, as Modified by Amendment No. 1, To Implement Changes to the Required Fund Deposit Calculation in the Government Securities Division Rulebook | |
83 FR 26511 - Self-Regulatory Organizations; New York Stock Exchange LLC; Notice of Filing and Immediate Effectiveness of Proposed Rule Change To Amend the NYSE Proprietary Market Data Fee Schedule Regarding the NYSE Best Quote and Trades Market Data Feed | |
83 FR 26507 - Self-Regulatory Organizations; New York Stock Exchange LLC; Notice of Filing and Immediate Effectiveness of Proposed Rule Change To Amend the Content of the NYSE Best Quote & Trades Data Feed | |
83 FR 26510 - Submission for OMB Review; Comment Request | |
83 FR 26506 - Sprott ETF Trust and Sprott Asset Management USA Inc. | |
83 FR 26542 - Notice of OFAC Sanctions Actions | |
83 FR 26410 - Bayer CropScience LP; Availability of a Preliminary Plant Pest Risk Assessment, Draft Environmental Assessment, Preliminary Finding of No Significant Impact, and Preliminary Determination of Nonregulated Status for Cotton Genetically Engineered For Resistance to HPPD-Inhibitor Herbicides (e.g., Isoxaflutole) and Glyphosate | |
83 FR 26410 - Notice of a Determination Regarding the Classical Swine Fever and Swine Vesicular Disease Status of Japan | |
83 FR 26533 - Administrative Declaration of a Disaster for the Commonwealth of VIRGINIA | |
83 FR 26461 - Open Commission Meeting, Thursday, June 7, 2018 | |
83 FR 26396 - Transforming the 2.5 GHz Band | |
83 FR 26463 - Information Collection Being Reviewed by the Federal Communications Commission | |
83 FR 26457 - Information Collection Being Submitted for Review and Approval to the Office of Management and Budget | |
83 FR 26460 - Information Collection Being Submitted for Review and Approval to the Office of Management and Budget | |
83 FR 26487 - Prospective Grant of an Exclusive Patent License: The Development of an Anti-BCMA Immunotoxin for the Treatment of Human Cancer | |
83 FR 26488 - National Institute of Nursing Research; Notice to Close Meeting | |
83 FR 26489 - National Institute of Nursing Research; Notice to Close Meeting | |
83 FR 26489 - National Institute of Mental Health; Notice of Closed Meeting | |
83 FR 26486 - National Institute of Arthritis and Musculoskeletal and Skin Diseases; Notice of Closed Meetings | |
83 FR 26489 - Center for Scientific Review; Notice of Closed Meetings | |
83 FR 26389 - Airworthiness Directives; 328 Support Services GmbH (Type Certificate Previously Held by AvCraft Aerospace GmbH; Fairchild Dornier GmbH; Dornier Luftfahrt GmbH) Airplanes | |
83 FR 26383 - Airworthiness Directives; The Boeing Company Airplanes | |
83 FR 26381 - Airworthiness Directives; Honda Aircraft Company LLC | |
83 FR 26374 - General Technical, Organizational, Conforming, and Correcting Amendments to the Federal Motor Carrier Safety Regulations; Correction | |
83 FR 26349 - Airworthiness Directives; Aircraft Industries a.s. Airplanes | |
83 FR 26352 - Airworthiness Directives; Bombardier, Inc., Airplanes |
Animal and Plant Health Inspection Service
International Trade Administration
National Oceanic and Atmospheric Administration
National Telecommunications and Information Administration
Air Force Department
Federal Energy Regulatory Commission
Centers for Disease Control and Prevention
Food and Drug Administration
National Institutes of Health
Coast Guard
Federal Emergency Management Agency
Alcohol, Tobacco, Firearms, and Explosives Bureau
Antitrust Division
Federal Aviation Administration
Federal Highway Administration
Federal Motor Carrier Safety Administration
Federal Railroad Administration
Federal Transit Administration
Pipeline and Hazardous Materials Safety Administration
Comptroller of the Currency
Foreign Assets Control Office
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 electronic mailing list, go to https://public.govdelivery.com/accounts/USGPOOFR/subscriber/new, enter your e-mail address, then follow the instructions to join, leave, or manage your subscription.
Office of the Comptroller of the Currency, Treasury (“OCC”); and Federal Deposit Insurance Corporation (“FDIC”).
Final rule.
The OCC and the FDIC (“Agencies”) are adopting a final rule to shorten the standard settlement cycle for securities purchased or sold by national banks, federal savings associations, and FDIC-supervised institutions. The Agencies' final rule is consistent with an industry-wide transition to a two business-day settlement cycle, which is designed to reduce settlement exposure and align settlement practices across all market participants.
This final rule is effective October 1, 2018.
On September 5, 2017, the securities industry in the United States transitioned from a standard securities settlement cycle of three business days after the date of the contract, commonly known as “T+3,” to a two-business day standard, or “T+2.” The transition was the culmination of a multi-year securities industry initiative and rule changes implemented by the U.S. Securities and Exchange Commission and securities self-regulatory organizations (such as the Financial Industry Regulatory Authority and the Municipal Securities Rulemaking Board). In connection with the transition to T+2, on June 9, 2017, the OCC issued Bulletin 2017-22, which notified national banks, federal savings associations (“FSAs”), federal branches, and federal agencies (together, “OCC-supervised institutions”) that they should be in compliance with T+2 as of September 5, 2017. The FDIC issued similar guidance applicable to FDIC-supervised institutions
Regulations governing recordkeeping and confirmation requirements for the securities transactions of national banks and FSAs, both for the bank's own account and for customers, are set out in parts 12 and 151 of the OCC's regulations, respectively. Regulations governing the same for FDIC-supervised institutions are set out in part 344 of the FDIC's regulations. These regulations require that banks generally not effect or enter into a contract for the purchase or sale of a security that provides for payment of funds and delivery of securities later than the third business day after the date of the contract, unless otherwise expressly agreed to by the parties at the time of the transaction.
On September 11, 2017, the Agencies published in the
The Agencies received three responses to their request for comment. The Investment Company Institute (“ICI”) and the Securities Industry and Financial Markets Association (“SIFMA”) both “strongly” supported the proposal as a path to aligning the Agencies' regulations with those applicable to other market participants in the United States. A third commenter, an individual, also expressed support for the final rule. Both ICI and SIFMA expressed a preference for the alternative approach. After considering these comments, the Agencies decided to adopt the alternative approach in order to maintain alignment more readily between the settlement period applicable to banks and the standard settlement cycle followed by registered broker dealers in the United States.
The final rule will require banks to settle most securities transactions within the number of business days in the “standard settlement cycle followed by registered broker dealers in the United States” unless otherwise agreed to by the parties at the time of the transaction. Banks will be able to determine the number of business days in the standard settlement cycle
The final rule amends the OCC and FDIC regulations at parts 12, 151, and 344, which govern the recordkeeping and confirmation requirements for bank securities transactions. In order to accommodate the change described above, the Agencies made certain additional, purely editorial changes to the language of these parts. The additional changes were intended to make the regulations easier to follow and understand in light of the revisions necessary to implement the alternative approach.
The effective date for this final rule is October 1, 2018. The Agencies understand that, consistent with the industry's transition to T+2, banks are already in compliance with a two-day settlement standard as a practical matter.
Under the Paperwork Reduction Act (“PRA”), 44 U.S.C. 3501-3520, the Agencies may not conduct or sponsor, and a person is not required to respond to, an information collection unless the information collection displays a valid Office of Management and Budget (“OMB”) control number. This final rule does not introduce or change any collections of information; therefore, it does not require a submission to OMB. The Agencies invited comment on their PRA determination when issuing the proposed rule, and no responsive comments were received.
The Regulatory Flexibility Act, 5 U.S.C. 601
As of December 31, 2017, the FDIC supervises 3,643 depository institutions, of which 2,924 are defined as small banking entities by the terms of the RFA. The transition of the standard settlement cycle to two days will reduce by one day the settlement time of transactions for equities, corporate bonds, municipal bonds, unit investment trusts, mutual funds, exchange-traded funds, exchange-traded products, American depository receipts, options, rights, and warrants. According to recent Call Report data, 2,565 FDIC-supervised small entities reported holding some volume of equities that are likely to be affected by the new securities settlement cycle, provide custodial banking services, or possess a subsidiary classified as a securities dealer.
The effects on small entities will vary according to the degree of participation in securities transactions. According to recent Call Report data one small entity identified itself as providing custodial banking services, while seven small entities have a subsidiary classified as a securities dealer according to data from the Federal Reserve's National Information Center.
As discussed above, because the industry has already implemented the practice of a standard settlement cycle, currently consisting of two days, and because the final rule does not contain any new recordkeeping, reporting, or compliance requirements, the FDIC anticipates that it will not impose any significant additional costs on FDIC-supervised institutions. Thus, the final rule will not have a substantial impact on any FDIC-supervised small entities. Therefore, the FDIC certifies that the final rule would not have a significant economic impact on a substantial number of FDIC-supervised small entities.
The OCC analyzed the final rule under the factors set forth in the Unfunded Mandates Reform Act of 1995 (2 U.S.C. 1532). Under this analysis, the OCC considered whether the final rule includes a federal mandate that may result in the expenditure by state, local, and Tribal governments, in the aggregate, or by the private sector, of $100 million or more in any one year (adjusted annually for inflation).
The rule does not impose new mandates. Therefore, the OCC concludes that implementation of the rule will not result in an expenditure of $100 million or more annually by state, local, and tribal governments, or by the private sector.
The Riegle Community Development and Regulatory Improvement Act (“RCDRIA”) requires that the Agencies, in determining the effective date and administrative compliance requirements of new regulations that impose additional reporting, disclosure, or other requirements on insured depository institutions (“IDIs”), consider, consistent with principles of safety and soundness and the public interest, any administrative burdens that such regulations would place on depository institutions, including small depository institutions, and customers of depository institutions, as well as the benefits of such regulations. 12 U.S.C. 4802. In addition, in order to provide an adequate transition period, new regulations that impose additional reporting, disclosures, or other new requirements on IDIs generally must take effect on the first day of a calendar quarter that begins on or after the date on which the regulations are published in final form.
The final rule includes no additional reporting, disclosure, or other requirements on IDIs, including small depository institutions, nor on the customers of depository institutions. Therefore, the requirements of RCDRIA
Section 722 of the Gramm-Leach-Bliley Act requires the Agencies to use plain language in all proposed and final rules published after January 1, 2000. When issuing a proposed rule, the Agencies invited comment on how to make this rule easier to understand. No comments responsive to this issue were received.
Banks, Banking, Federal savings associations, National banks, Reporting and recordkeeping requirements, Securities.
Banks, Banking, Reporting and recordkeeping requirements, Savings associations.
OCC amends 12 CFR parts 12 and 151 and FDIC amends 12 CFR part 344 as follows:
12 U.S.C. 24, 92a, and 93a.
(a) All contracts effected or entered into by a national bank for the purchase or sale of a security (other than an exempted security as defined in 15 U.S.C. 78c(a)(12), government security, municipal security, commercial paper, bankers' acceptances, or commercial bills) shall provide for completion of the transaction within the number of business days in the standard settlement cycle followed by registered broker dealers in the United States, unless otherwise agreed to by the parties at the time of the transaction. The number of business days in the standard settlement cycle shall be determined by reference to paragraph (a) of SEC Rule 15c6-1, 17 CFR 240.15c6-1(a).
12 U.S.C. 1462a, 1463, 1464, 5412(b)(2)(B).
The revisions and addition are set forth below.
(a) You may not effect or enter into a contract for the purchase or sale of a security that provides for payment of funds and delivery of securities later than the latest of:
(1) The number of business days in the standard settlement cycle followed by registered broker dealers in the United States after the date of the contract. The number of business days in the standard settlement cycle shall be determined by reference to paragraph (a) of SEC Rule 15c6-1, 17 CFR 240.15c6-1(a);
(2) The fourth business day after the contract, if the contract involves the sale for cash of securities that are priced after 4:30 p.m. Eastern Standard Time on the date the securities are priced and are sold by an issuer to an underwriter under a firm commitment underwritten offering registered under the Securities Act of 1933, 15 U.S.C. 77a,
(3) Such time as the SEC may specify pursuant to an order of exemption in accordance with paragraph (b)(2) of SEC Rule 15c6-1; or
12 U.S.C. 1817, 1818, 1819, and 5412.
(a) All contracts effected or entered into by an FDIC-supervised institution that provide for the purchase or sale of a security (other than an exempted security as defined in 15 U.S.C. 78c(a)(12), government security, municipal security, commercial paper, bankers' acceptances, or commercial bills) shall provide for completion of the transaction within the number of business days in the standard settlement cycle followed by registered broker dealers in the United States, unless otherwise agreed to by the parties at the time of the transaction. The number of business days in the standard settlement cycle shall be determined by reference to paragraph (a) of SEC Rule 15c6-1, 17 CFR 240.15c6-1(a).
By order of the Board of Directors.
Federal Aviation Administration (FAA), DOT.
Final rule; request for comments.
We are adopting a new airworthiness directive (AD) for Aircraft Industries a.s. Models L 410 UVP-E20 and L 410 UVP-E20 CARGO airplanes. This AD results from mandatory continuing airworthiness information (MCAI) issued by the aviation authority of another country to identify and correct an unsafe condition on an aviation product. The MCAI describes the unsafe condition as un-commanded negative thrust mode activated on an engine. We are issuing this AD to require actions to address the unsafe condition on these products.
This AD is effective June 27, 2018.
The Director of the Federal Register approved the incorporation by reference of certain publications listed in the AD as of June 27, 2018.
We must receive comments on this AD by July 23, 2018.
You may send comments by any of the following methods:
•
•
•
•
For service information identified in this AD, contact Aircraft Industries, a.s., 686 04 Kunovice 1177, Czech Republic; phone: +420 572 817 664; fax: +420 572 816 112; email:
You may examine the AD docket on the internet at
Doug Rudolph, Aerospace Engineer, FAA, Small Airplane Standards Branch, 901 Locust, Room 301, Kansas City, Missouri 64106; telephone: (816) 329-4059; fax: (816) 329-4090; email:
The European Aviation Safety Agency (EASA), which is the Technical Agent for the Member States of the European Community, has issued AD No. 2018-0057, dated March 14, 2018 (referred to after this as “the MCAI”), to correct an unsafe condition for Aircraft Industries a.s. Models L 410 UVP-E20 and L 410 UVP-E20 CARGO airplanes and was based on mandatory continuing airworthiness information (MCAI) originated by an aviation authority of another country. The MCAI states:
The investigation results of an L 410 UVP-E20 accident identified that, during final approach, an un-commanded negative thrust mode was activated on the right-hand engine. Pending the investigation results of the accident, as a preliminary measure, EASA issued SIB 2017-21, recommending operators to check the components of engine and propeller control system, including the beta switch, in accordance with the instructions of Revision 1 of AI SB L410UVP-E/492b.
This condition, if not corrected, could lead to reduced or loss of control of an aeroplane.
To address this unsafe condition, AI issued the MB, providing modification instructions, and issued the DB, amending the Aircraft Flight Manual (AFM), providing instructions for the flight crew in case of inadvertent beta range cell activation in flight and introducing instructions for the flight crew to check the function of pitch lock system before each flight.
For the reasons described above, this [EASA] AD requires modification of the electrical testing circuit of the propeller pitch lock system and amendment of the applicable AFM.
EASA SIB 2017-21 has been withdrawn accordingly. You may examine the MCAI on the internet at
Aircraft Industries a.s. has issued LET Aircraft Industries Mandatory Bulletin MB No. L410UVP-E/143a, Revision 2, dated March 7, 2018; and LET Aircraft Industries Documentation Bulletin DB No. L410UVP-E/268d, dated May 9, 2018. Mandatory Bulletin MB No. L410UVP-E/143a describes procedures for modifying the electrical circuit of the propeller pitch lock system function test. Documentation Bulletin DB No. L410UVP-E/268d provides instructions for flight crew in case of inadvertent beta range cell activation in flight and instructions for a pre-flight check of the function of the pitch lock system. 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 this State of Design Authority, they have notified us of the unsafe condition described in the MCAI and service information referenced above. We are issuing this AD because we evaluated all information provided by the State of Design Authority and determined the unsafe condition exists and is likely to exist or develop on other products of the same type design.
An unsafe condition exists that requires the immediate adoption of this AD. The FAA has found that the risk to the flying public justifies waiving notice and comment prior to adoption of this rule because there are no airplanes currently on the U.S. registry and thus, does not have any impact upon the public. Therefore, we find good cause that notice and opportunity for prior public comment are unnecessary. In addition, for the reason(s) stated above, we find that good cause exists for making this amendment effective in less than 30 days.
The MCAI requires the AFM changes in accordance with DB No.: L410UVP-E/247d and DB No.: L410UVP-E/259d, both dated March 3, 2018. These documents only apply to airplanes operated under the European type certificate and do not apply to those airplanes operating under the FAA type certificate. Therefore, Aircraft Industries a.s. developed DB No.: L410UVP-E/268d, dated May 9, 2018, and this AD requires the AFM changes in accordance with this document.
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 will affect 0 products of U.S. registry. We also estimate that it would take about 9 work-hours per product to comply with the basic requirements of this AD. The average labor rate is $85 per work-hour. Required parts would cost about $2,000 per product.
Based on these figures, we estimate the cost of the AD on U.S. operators to be $0 fleet cost, but $2,765 per product if a product is registered on the U.S. registry.
According to the manufacturer, some of the costs of this AD may be covered under warranty, thereby reducing the cost impact on affected individuals. We do not control warranty coverage for affected individuals. As a result, we have included all costs in our cost estimate.
Title 49 of the United States Code specifies the FAA's authority to issue rules on aviation safety. Subtitle I, section 106, describes the authority of the FAA Administrator. “Subtitle VII: Aviation Programs,” describes in more detail the scope of the Agency's authority.
We are issuing this rulemaking under the authority described in “Subtitle VII, Part A, Subpart III, Section 44701: General requirements.” Under that section, Congress charges the FAA with promoting safe flight of civil aircraft in air commerce by prescribing regulations for practices, methods, and procedures the Administrator finds necessary for safety in air commerce. This regulation is within the scope of that authority because it addresses an unsafe condition that is likely to exist or develop on products identified in this rulemaking action.
This AD is issued in accordance with authority delegated by the Executive Director, Aircraft Certification Service, as authorized by FAA Order 8000.51C. In accordance with that order, issuance of ADs is normally a function of the Compliance and Airworthiness Division, but during this transition period, the Executive Director has delegated the authority to issue ADs applicable to small airplanes, gliders, balloons, airships, domestic business jet transport airplanes, and associated appliances to the Director of the Policy and Innovation Division.
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 airworthiness directive (AD) becomes effective June 27, 2018.
None.
This AD applies to the following Aircraft Industries a.s. Models L 410 UVP-E20 and L 410 UVP-E20 CARGO airplanes, manufacturer serial numbers 2904 through 3114, that are:
(1) Equipped with GE Aviation H80-200 engines and Avia Propeller AV 725 propellers; and
(2) certificated in any category.
Air Transport Association of America (ATA) Code 61: Propellers/Propulsors.
This AD was prompted by mandatory continuing airworthiness information (MCAI) issued by the aviation authority of another country to identify and correct an unsafe condition on an aviation product. The MCAI describes the unsafe condition as un-commanded negative thrust mode activated on an engine. We are issuing this AD to provide guidance to the flight crew in the event of un-commanded negative thrust mode activated on an engine, which could lead to loss of control.
Unless already done, do the following actions.
(1) Within the next 25 hours time-in-service (TIS) after the effective date of this AD or within the next 30 days after the effective date of this, whichever occurs first, modify the electrical testing circuit of the propeller pitch lock system following the Instructions for Implementation in LET Aircraft Industries Mandatory Bulletin MB No. L410UVP-E/143a, Revision 2, dated March 7, 2018.
(2) Within the next 25 hours TIS after the effective date of this AD or within the next 30 days after the effective date of this, whichever occurs first, incorporate airplane flight manual (AFM) changes following the Measures specified in LET Aircraft Industries Documentation Bulletin DB No. L410UVP-E/268d, dated May 9, 2018. After incorporating the AFM changes, operate the airplane accordingly.
(3) If any discrepancies are found during any pitch lock system pre-flight check required in the AFM changes specified in paragraph (f)(2) of this AD, before further flight, contact the manufacturer for FAA-approved repair instructions approved specifically for this AD. You may use the contact information found in paragraph (i)(3) of this AD.
The following provisions also apply to this AD:
(1)
(2)
Refer to MCAI EASA AD No. 2018-0057, dated March 14, 2018, for related information. You may examine the MCAI 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.
(i) LET Aircraft Industries Mandatory Bulletin MB No. L410UVP-E/143a, Revision 2, dated March 7, 2018.
(ii) LET Aircraft Industries Documentation Bulletin DB No. L410UVP-E/268d, dated May 9, 2018.
(3) For service information identified in this AD, contact Aircraft Industries, a.s., 686 04 Kunovice 1177, Czech Republic; phone: +420 572 817 664; fax: +420 572 816 112; email:
(4) You may view this service information at FAA, Policy and Innovation Division, 901 Locust, Kansas City, Missouri 64106. For information on the availability of this material at the FAA, call (816) 329-4148. It is also available on the internet at
(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 adopting a new airworthiness directive (AD) for all Bombardier, Inc., Model CL-600-2C10 (Regional Jet Series 700, 701, & 702) airplanes, Model CL-600-2D15 (Regional Jet Series 705) airplanes, Model CL-600-2D24 (Regional Jet Series 900) airplanes, and Model CL-600-2E25 (Regional Jet Series 1000) airplanes. This AD was prompted by a report that Belleville washers installed on the shimmy damper of the main landing gear (MLG) may fail due to fatigue. This AD requires revising the maintenance or inspection program, as applicable, to incorporate a repetitive task specified in the maintenance review board (MRB) report. We are issuing this AD to address the unsafe condition on these products.
This AD is effective July 12, 2018.
The Director of the Federal Register approved the incorporation by reference of a certain publication listed in this AD as of July 12, 2018.
For service information identified in this final rule, contact Bombardier, Inc., 400 Côte-Vertu Road West, Dorval, Québec H4S 1Y9, Canada; Widebody Customer Response Center North America toll-free telephone 1-866-538-1247 or direct-dial telephone 1-514-855-2999; fax 514-855-7401; email
You may examine the AD docket on the internet at
Cesar Gomez, Aerospace Engineer, Airframe and Mechanical Systems Section, FAA, New York ACO Branch, 1600 Stewart Avenue, Suite 410, Westbury, NY 11590; telephone 516-228-7318; fax 516-794-5531.
We issued a notice of proposed rulemaking (NPRM) to amend 14 CFR part 39 by adding an AD that would apply to all Bombardier, Inc., Model CL-600-2C10 (Regional Jet Series 700, 701, & 702) airplanes, Model CL-600-2D15 (Regional Jet Series 705) airplanes, Model CL-600-2D24 (Regional Jet Series 900) airplanes, and Model CL-600-2E25 (Regional Jet Series 1000) airplanes. The NPRM published in the
Transport Canada Civil Aviation (TCCA), which is the aviation authority for Canada, has issued Canadian AD CF-2017-14, dated April 21, 2017 (referred to after this as the Mandatory Continuing Airworthiness Information, or “the MCAI”), to correct an unsafe condition for all Bombardier, Inc., Model CL-600-2C10 (Regional Jet Series 700, 701, & 702) airplanes, Model CL-600-2D15 (Regional Jet Series 705) airplanes, Model CL-600-2D24 (Regional Jet Series 900) airplanes, and Model CL-600-2E25 (Regional Jet Series 1000) airplanes. The MCAI states:
It has been found that Belleville washers installed on the Main Landing Gear (MLG) Shimmy Damper may fail in fatigue. A failed washer segment migrating into the piston cavity may interfere with piston travel. As a result, shimmy damper performance would be compromised, MLG shimmy could occur and potentially lead to a MLG failure.
As a result of this investigation, a restoration task has been added for Belleville washers' replacement at 20,000 flight cycles, during MLG overhaul. For aeroplanes that have passed the 20,000 flight cycle threshold, a phase-in period is defined.
This [Canadian] AD is issued to mandate the Maintenance Review Board (MRB)
We gave the public the opportunity to participate in developing this AD. The following presents the comment received on the NPRM and the FAA's response to that comment.
Bombardier stated that task number 320100-229, Restoration (Belleville Washer Replacement) of the MLG Shimmy Damper, of the MRB Report of the Bombardier CRJ700/900/1000 Maintenance Requirements Manual (MRM)—Part 1, Volume 1, CSP B-053, Revision 17, dated June 25, 2017, is currently specified in paragraph (g) of the proposed AD. Bombardier commented that it is planning to issue Revision 18 of the service information by June 25, 2018. Bombardier stated to contact Bombardier for the latest service information should the AD be published after June 25, 2018.
We expect to issue this AD prior to the anticipated date of release of new service information, and we do not agree to delay issuance of this AD until new service information is released. However, if new service information is released after this AD is issued, operators may request approval of an alternative method of compliance (AMOC) under the provisions of paragraph (j)(1) of this AD. We have not changed this AD regarding this issue.
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.
Bombardier has issued MRB report task number 320100-229, Restoration (Belleville Washer Replacement) of the MLG Shimmy Damper, of the MRB Report of the Bombardier CRJ700/900/1000 Maintenance Requirements Manual (MRM)—Part 1, Volume 1, CSP B-053, Revision 17, dated June 25, 2017. This service information describes the restoration (Belleville Washer Replacement) of the MLG shimmy damper. 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 544 airplanes of U.S. registry.
We estimate the following costs to comply with this AD:
We have determined that revising the maintenance or inspection program takes an average of 90 work-hours per operator, although we recognize that this number may vary from operator to operator. In the past, we have estimated that this action takes 1 work-hour per airplane. Since operators incorporate maintenance or inspection program changes for their affected fleet(s), we have determined that a per-operator estimate is more accurate than a per-airplane estimate. Therefore, we estimate the total cost per operator to be $7,650 (90 work-hours x $85 per work-hour).
Title 49 of the United States Code specifies the FAA's authority to issue rules on aviation safety. Subtitle I, section 106, describes the authority of the FAA Administrator. Subtitle VII: Aviation Programs, describes in more detail the scope of the Agency's authority.
We are issuing this rulemaking under the authority described in Subtitle VII, Part A, Subpart III, Section 44701: “General requirements.” Under that section, Congress charges the FAA with promoting safe flight of civil aircraft in air commerce by prescribing regulations for practices, methods, and procedures the Administrator finds necessary for safety in air commerce. This regulation is within the scope of that authority because it addresses an unsafe condition that is likely to exist or develop on products identified in this rulemaking action.
This AD is issued in accordance with authority delegated by the Executive Director, Aircraft Certification Service, as authorized by FAA Order 8000.51C. In accordance with that order, issuance of ADs is normally a function of the Compliance and Airworthiness Division, but during this transition period, the Executive Director has delegated the authority to issue ADs applicable to transport category airplanes to the Director of the System Oversight Division.
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 is effective July 12, 2018.
None.
This AD applies to all Bombardier, Inc., Model CL-600-2C10 (Regional Jet Series 700, 701, & 702) airplanes, Model CL-600-2D15 (Regional Jet Series 705) airplanes, Model CL-600-2D24 (Regional Jet Series 900) airplanes, and Model CL-600-2E25 (Regional Jet Series 1000) airplanes, certificated in any category.
Air Transport Association (ATA) of America Code 32, Landing gear.
This AD was prompted by a report indicating that Belleville washers installed on the shimmy damper of the main landing gear (MLG) may fail due to fatigue. We are issuing this AD to prevent a failed washer segment migrating into the piston cavity and interfering with piston travel. As a result, the shimmy damper performance could be compromised, and an MLG shimmy could occur, potentially leading to an MLG failure and affecting the airplane's safe flight and landing.
Comply with this AD within the compliance times specified, unless already done.
Within 30 days after the effective date of this AD, revise the airplane maintenance or inspection program, as applicable, by incorporating maintenance review board (MRB) report task number 320100-229, Restoration (Belleville Washer Replacement) of the MLG Shimmy Damper, of the MRB Report of the Bombardier CRJ700/900/1000 Maintenance Requirements Manual (MRM)—Part 1, Volume 1, CSP B-053, Revision 17, dated June 25, 2017. The initial compliance time for MRB report task number 320100-229 is specified in paragraphs (g)(1) and (g)(2) of this AD, as applicable.
(1) For any shimmy damper with 20,000 total accumulated flight cycles or fewer as of the effective date of this AD, the initial compliance time is before the accumulation of 26,000 total flight cycles.
(2) For any shimmy damper with 20,000 total accumulated flight cycles or more as of the effective date of this AD, the initial compliance time is specified in paragraph (g)(2)(i) or (g)(2)(ii), whichever occurs later.
(i) Within 6,000 flight cycles after the effective date of this AD, but prior to the accumulation of 30,000 total flight cycles.
(ii) Within 30 days after effective date of this AD.
This paragraph provides credit for actions required by paragraph (g) of this AD, if those actions were performed before the effective date of this AD using Bombardier Temporary Revision MRB-0070, dated October 20, 2015.
After the airplane maintenance or inspection program has been revised, as required by paragraph (g) of this AD, no alternative actions (
The following provisions also apply to this AD:
(1)
(2)
(1) Refer to Mandatory Continuing Airworthiness Information (MCAI) Canadian Airworthiness Directive CF-2017-14, dated April 21, 2017, for related information. This MCAI may be found in the AD docket on the internet at
(2) For more information about this AD, contact Cesar Gomez, Aerospace Engineer, Airframe and Mechanical Systems Section, FAA, New York ACO Branch, 1600 Stewart Avenue, Suite 410, Westbury, NY 11590; telephone 516-228-7318; fax 516-794-5531.
(3) Service information identified in this AD that is not incorporated by reference is available at the addresses specified in paragraphs (l)(3) and (l)(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 this AD specifies otherwise.
(i) Maintenance review board (MRB) report task number 320100-229, Restoration (Belleville Washer Replacement) of the MLG Shimmy Damper, of the MRB Report of the Bombardier CRJ700/900/1000 Maintenance Requirements Manual (MRM)—Part 1, Volume 1, CSP B-053, Revision 17, dated June 25, 2017.
(ii) Reserved.
(3) For service information identified in this AD, contact Bombardier, Inc., 400 Côte-Vertu Road West, Dorval, Québec H4S 1Y9, Canada; Widebody Customer Response Center North America toll-free telephone 1-866-538-1247 or direct-dial telephone 1-514-855-2999; fax 514-855-7401; email
(4) You may view this service information at the FAA, Transport Standards Branch, 2200 South 216th St., Des Moines, WA. For information on the availability of this material at the FAA, call 206-231-3195.
(5) You may view this service information that is incorporated by reference at the National Archives and Records Administration (NARA). For information on the availability of this material at NARA, call 202-741-6030, or go to:
Delaware River Basin Commission.
Final rule.
Notice is provided of the Commission's regulatory program fees and schedule of water charges for the fiscal year beginning July 1, 2018.
This final rule is effective July 1, 2018.
Elba L. Deck, CPA, Director of Administration and Finance, 609-883-9500, ext. 201.
The Delaware River Basin Commission (“DRBC” or “Commission”) is a Federal-interstate compact agency charged with managing the water resources of the Delaware River Basin on a regional basis without regard to political boundaries. Its members are the governors of the four basin states—Delaware, New Jersey, New York and Pennsylvania—and on behalf of the federal government, the North Atlantic Division Commander of the U.S. Army Corps of Engineers.
In accordance with 18 CFR 401.43(c), on July 1 of every year beginning July 1, 2017, the Commission's regulatory program fees as set forth in Tables 1, 2 and 3 of that section are subject to an annual adjustment, commensurate with any increase in the annual April 12-month Consumer Price Index (CPI) for Philadelphia published by the U.S. Bureau of Labor Statistics during that
This notification is made in accordance with 18 CFR 401.42(c) and 18 CFR 420.42(c), which provide that a revised fee schedule will be published in the
Administrative practice and procedure, Project review, Water pollution control, Water resources.
Water supply.
For the reasons set forth in the preamble, the Delaware River Basin Commission amends parts 401 and 420 of title 18 of the Code of Federal Regulations as set forth below:
Delaware River Basin Compact (75 Stat. 688), unless otherwise noted.
Delaware River Basin Compact, 75 Stat. 688.
(a) $82.14 per million gallons for consumptive use, subject to paragraph (c) of this section; and
(b) $0.82 per million gallons for non-consumptive use, subject to paragraph (c) of this section.
Food and Drug Administration, HHS.
Final rule.
The Food and Drug Administration (FDA or we) is amending the color additive regulations to provide for the safe use of D&C Black No. 4 for coloring ultra-high molecular weight polyethylene (UHMWPE) non-absorbable sutures for use in general surgery. This action is in response to a color additive petition (CAP) submitted by DSM Biomedical.
This rule is effective July 10, 2018. See section VIII for further information on the filing of objections. Submit either electronic or written objections and requests for a hearing on the final rule by July 9, 2018.
You may submit objections and requests for a hearing as follows. Please note that late, untimely filed objections will not be considered. Electronic objections must be submitted on or before July 9, 2018. The
Submit electronic objections in the following way:
•
• If you want to submit an objection with confidential information that you do not wish to be made available to the public, submit the objection as a written/paper submission and in the manner detailed (see “Written/Paper Submissions” and “Instructions”).
Submit written/paper submissions as follows:
•
• For written/paper objections submitted to the Dockets Management Staff, FDA will post your objection, as well as any attachments, except for information submitted, marked and identified, as confidential, if submitted as detailed in “Instructions.”
• Confidential Submissions—To submit an objection with confidential information that you do not wish to be made publicly available, submit your objections only as a written/paper submission. You should submit two copies total. One copy will include the information you claim to be confidential with a heading or cover note that states “THIS DOCUMENT CONTAINS CONFIDENTIAL INFORMATION.” We will review this copy, including the claimed confidential information, in our consideration of comments. The second copy, which will have the claimed confidential information redacted/blacked out, will be available for public viewing and posted on
Joseph M. Thomas, Center for Food Safety and Applied Nutrition (HFS-265), Food and Drug Administration, 5001 Campus Dr., College Park, MD 20740-3835, 301-796-9465.
In the
D&C Black No. 4 is a high-purity carbon black prepared by the oil furnace process. It is manufactured by injecting
As explained in section III, the color additive D&C Black No. 4 may contain low levels of potentially carcinogenic polycyclic aromatic hydrocarbon (PAH) contaminants. To limit the amounts of these contaminants in the color additive, FDA is setting specifications for total PAHs, as well as for the individual PAH species benzo[
The identity for D&C Black No. 4 is the same as D&C Black No. 2, except for the surface area. For D&C Black No. 2, we set specifications for arsenic, lead, and mercury, total color (as carbon), total sulfur, ash content, surface area, and weight loss on heating, in addition to the specifications for total PAHs, benzo[
Under section 721(b)(4) of the Federal Food, Drug, and Cosmetic Act (FD&C Act) (21 U.S.C. 379e(b)(4)), a color additive cannot be listed for a particular use unless a fair evaluation of the data and information available to FDA establish that the color additive is safe under the intended conditions of use. Furthermore, under 21 CFR 70.5(c), a color additive intended for use in a surgical suture must have a listing specifically providing for this use. FDA's color additive regulations in 21 CFR 70.3(i) define “safe” to mean that there is convincing evidence that establishes with reasonable certainty that no harm will result from the intended use of the color additive.
Section 721(b)(5)(B)(ii) of the FD&C Act provides that for any use of a color additive that will not result in ingestion of any part of such additive, the color additive shall be deemed to be unsafe and shall not be listed if, after tests that are appropriate for the evaluation of the safety of additives for such use, or after other relevant exposure of man or animal to such additive, it is found to induce cancer in man or animal. Importantly, however, section 721(b)(5)(B) of the FD&C Act applies to the additive itself and not to impurities in the additive. That is, where an additive itself has not been shown to cause cancer, but contains a carcinogenic impurity, the additive is properly evaluated under the general safety standard using risk assessment procedures to determine whether there is a reasonable certainty that no harm will result from the intended use of the additive (
In evaluating the safety of a color additive, FDA customarily reviews the available data on each relevant chemical impurity to determine whether the chemical induces tumors in animals or humans. If FDA concludes that the chemical impurity causes cancer in animals or humans, the Agency calculates the unit cancer risk for the chemical and the upper bound limit of lifetime human cancer risk from the chemical's presence in the additive. To establish with reasonable certainty that D&C Black No. 4 intended to color UHMWPE non-absorbable sutures is not harmful under the intended conditions of use, we have considered the exposure to the color additive and its impurities, the additive's toxicological data, and other relevant information (such as published literature) available to us.
The petitioner incorporated safety information that was previously submitted to FDA on behalf of Cabot Corp. in Food Additive Petition 5B4464 by reference to support the safety of high-purity furnace black as a colorant for polymers in food-contact applications. D&C Black No. 4 is manufactured in the same manner as the referenced high-purity furnace black.
The petitioner also submitted data from an extraction study testing the migration of D&C Black No. 4 from UHMWPE sutures and provided data from two studies demonstrating biocompatibility of UHMWPE sutures along with other information. The petitioner's data from the extraction study indicated that D&C Black No. 4, when added to UHMWPE non-absorbable sutures at the maximum level of 1 percent, remains physically embedded in the suture matrix resulting in the color additive not being detected in the extracts at the limit of quantitation. This study evaluated the amount of non-volatile residue (NVR) and any extractables that could migrate from the suture. The study was performed with water, hexane, and ethanol at 50 °C for 24 hours and demonstrated that D&C Black No. 4 does not migrate from the suture following exposure to solvents with varying polarities and exposure to heat. The study also yielded NVRs not able to be analyzed. To estimate potential exposure from D&C Black No. 4, the petitioner used data from the extraction study and the conservative assumption that all of the NVR that was extracted and not able to be analyzed was D&C Black No. 4. The petitioner derived an estimate for the mass amount of D&C Black No. 4 expected to migrate over a lifetime, expressed as the mean daily exposure, based on its proposed use level in surgical sutures, and using data for the maximum NVR extracted and the surface area of the tested sutures.
While FDA agrees with using the conservative assumption that all NVR extracted was D&C Black No. 4, the petitioner's exposure estimate represents the scenario where D&C Black No. 4 would migrate from the sutures 1 day post-implantation. However, since non-absorbable sutures are intended to be left in the body indefinitely post-implantation, it is necessary to average the petitioner's exposure estimate over an individual's lifetime post-implantation (assumed to be 70 years) to estimate the lifetime average exposure to D&C Black No. 4. In this manner, we estimated the lifetime average exposure to D&C Black No. 4 to
As discussed in section II, D&C Black No. 4 has been shown to contain low levels of PAH impurities, some of which are carcinogenic. We have previously considered the safe use of high-purity carbon black as a color additive in cosmetics (D&C Black No. 2; § 74.2052) and as a colorant in food-contact polymers (high-purity furnace black; § 178.3297) and set limits for PAHs in these high-purity carbon blacks to minimize exposure. We are setting similar limits for PAHs in D&C Black No. 4 as those established for D&C Black No. 2: Total PAHs (not more than 0.5 milligrams per kilogram (mg/kg) (500 parts per billion)); B[
There were no detectable PAHs at the limit of quantitation resulting from the petitioner's extraction study. The petitioner stated that the trace levels of PAHs in the color additive, as limited by specifications, are strongly bound to the surface of D&C Black No. 4 carbon particles due to the powerful adsorption capabilities of the color additive. FDA concurs that any PAH impurities are not expected to migrate under the proposed specifications and conditions of use (Ref. 1). In calculating the lifetime average exposure to PAHs from the use of D&C Black No. 4 in sutures, we used the conservative assumption that total PAHs, B[
Current data have shown B[
Based on the data and information in the petition and other available relevant material, FDA concludes that the petitioned use of D&C Black No. 4 for coloring UHMWPE non-absorbable sutures for use in general surgery is safe. We further conclude that the additive will achieve its intended technical effect and is suitable for the petitioned uses. Based on the available information, we are amending the color additive regulations in part 74 as set forth in this document. In addition, in accordance with 21 CFR 71.20(b), we conclude that batch certification of D&C Black No. 4 is necessary for the protection of public health because of the need to limit the levels of PAHs, some of which have been shown to be carcinogenic. Therefore, part 74 should be amended as set forth in this document.
In accordance with § 71.15 (21 CFR 71.15), the petition and the documents that we considered and relied upon in reaching our decision to approve the petition will be made available for public disclosure (see
We previously considered the environmental effects of this rule, as stated in the notice of petition published in the
This final rule contains no collection of information. Therefore, clearance by the Office of Management and Budget under the Paperwork Reduction Act of 1995 is not required.
This rule is effective as shown in the
Any objections received in response to the regulation may be seen in the Dockets Management Staff between 9 a.m. and 4 p.m., Monday through Friday, and will be posted to the docket at
The following references are on display with the Dockets Management Staff (see
Color additives, Cosmetics, Drugs.
Therefore, under the Federal Food, Drug, and Cosmetic Act and under authority delegated to the Commissioner of Food and Drugs, 21 CFR part 74 is amended as follows:
21 U.S.C. 321, 341, 342, 343, 348, 351, 352, 355, 361, 362, 371, 379e.
(a)
(b)
(1) Surface area by nitrogen BET (Brunauer, Emmett, Teller) method, 50 to 260 m
(2) Weight loss on heating at 950 °C for 7 minutes (predried for 1 hour at 125 °C), not more than 2 percent.
(3) Ash content, not more than 0.15 percent.
(4) Arsenic (total), not more than 3 milligrams per kilogram (mg/kg) (3 parts per million).
(5) Lead (total), not more than 10 mg/kg (10 parts per million).
(6) Mercury (total), not more than 1 mg/kg (1 part per million).
(7) Total sulfur, not more than 0.65 percent.
(8) Total polycyclic aromatic hydrocarbons (PAHs), not more than 0.5 mg/kg (500 parts per billion).
(9) Benzo[
(10) Dibenz[
(11) Total color (as carbon), not less than 95 percent.
(c)
(2) Authorization and compliance with this use must not be construed as waiving any of the requirements of sections 510(k), 515, and 520(g) of the Federal Food, Drug, and Cosmetic Act with respect to the ultra-high molecular weight polyethylene surgical sutures in which D&C Black No. 4 is used.
(d)
(e)
Office of General Counsel, HUD.
Final rule.
This final rule corrects HUD's regulations by removing cross references to appendices and a subpart that were removed by earlier rulemakings. In 1995, HUD removed several appendices throughout HUD's regulations deemed unnecessary or obsolete. In 1996, HUD consolidated its hearing procedures for nondiscrimination and equal opportunity matters in a new CFR part and removed the subpart of another. Cross-references to the removed appendices and subpart were not removed, however. This final rule corrects HUD's regulations by removing cross references to these nonexistent appendices and subpart.
Ariel Pereira, Associate General Counsel, Office of Legislation and Regulations, Department of Housing and Urban Development, 451 7th Street SW, Room 10282, Washington, DC 20410; telephone number 202-402-5138 (this is not a toll-free number). Persons with hearing or speech impairments may access this number through TTY by calling the Federal Relay Service at 800-877-8339 (this is a toll-free number).
On September 11, 1995 (60 FR 47260), HUD published a final rule entitled, “Elimination of Obsolete Parts” which removed from 24 CFR several appendices deemed obsolete and unnecessary. HUD undertook the regulation consistent with the “Regulatory Reinvention Initiative,” which required federal agencies to eliminate outdated regulations and modify others to reduce regulatory burden. Among the provisions removed were appendix A in 24 CFR part 1, appendices A and B in 24 CFR part 8, appendix A in 24 CFR part 16, and appendix A in 24 CFR part 40.
On October 4, 1996 (61 FR 52216), HUD published a final rule entitled, “Consolidated HUD Hearing Procedures for Civil Rights Matters,” which revised
HUD has determined that while these 1995 and 1996 rules removed the above-mentioned appendices and subpart, cross references to these nonexistent appendices and subpart remain in title 24.
This final rule removes cross references in title 24 to the nonexistent appendices and subpart. In 24 CFR part 16, however, removing the references to the nonexistent appendices requires that HUD revise § 16.3 to keep the meaning of the regulation the same. The deleted appendix in 24 CFR part 16 contained the address for Privacy Act inquiries, and this rule replaces the reference to the removed appendix with the current contact address for HUD's Privacy Act Officer. In removing 24 CFR part 40, appendix A, HUD decided to no longer provide a copy of the Uniform Federal Accessibility Standards text in its regulation, given that the information is publicly available and HUD's appendix would be outdated every time the United States Access Board updated the standards. HUD is not providing an updated cross-reference in 24 CFR part 40 but notes in this final rule that the public may access the most current Uniform Federal Accessibility Standards by visiting the website for the United States Access Board at
HUD generally publishes a rule for public comment before issuing a rule for effect, in accordance with its own regulations on rulemaking at 24 CFR part 10. Part 10 provides for exceptions to the general rule if the agency finds good cause to omit advance notice and public participation. The good cause requirement is satisfied when prior public procedure is “impracticable, unnecessary, or contrary to the public interest” (24 CFR 10.1;
The Regulatory Flexibility Act (RFA) (5 U.S.C. 601
Section 202 of the Unfunded Mandates Reform Act of 1995 (UMRA)
Executive Order 13132 (entitled “Federalism”) prohibits an agency from publishing any rule that has federalism implications if the rule either imposes substantial direct compliance costs on State and local governments and is not required by statute, or the rule preempts State law, unless the agency meets the consultation and funding requirements of section 6 of the Executive order. This rule will not have federalism implications and would not impose substantial direct compliance costs on State and local governments or preempt State law within the meaning of the Executive order.
This final rule does not direct, provide for assistance or loan and mortgage insurance for, or otherwise govern or regulate, real property acquisition, disposition, leasing, rehabilitation, alteration, demolition, or new construction, or establish, revise or provide for standards for construction or construction materials, manufactured housing, or occupancy. Accordingly, under 24 CFR 50.19(c)(1), this final rule is categorically excluded from environmental review under the National Environmental Policy Act of 1969 (42 U.S.C. 4321).
Administrative practice and procedure, Civil rights, Reporting and recordkeeping requirements.
Administrative practice and procedure, Civil rights, Equal employment opportunity, Grant programs—housing and community development, Individuals with disabilities, Loan programs—housing and community development, Reporting and recordkeeping requirements.
Privacy.
Individuals with disabilities, Public housing, Reporting and recordkeeping requirements.
Accordingly, for the reasons discussed in this preamble, HUD amends 24 CFR parts 1, 8, 16, and 40 as follows:
42 U.S.C. 2000d-1 and 3535(d).
29 U.S.C. 794; 42 U.S.C. 3535(d) and 5309.
5 U.S.C. 552(a); 42 U.S.C. 3535(d).
42 U.S.C. 3535(d), 4153.
Department of the Air Force, DoD.
Final rule.
This final rule removes the Department of the Air Force's regulation concerning the Freedom of Information Act program. On February 6, 2018, the DoD published a revised FOIA program rule as a result of the FOIA Improvement Act of 2016. When the DoD FOIA program rule was revised, it included DoD component information and removed the requirement for component supplementary rules. The DoD now has one DoD-level rule for the FOIA program at 32 CFR part 286 that contains all the codified information required for the Department. Therefore, this part can be removed from the CFR.
This rule is effective on June 7, 2018.
Bao-Anh Trinh at 703-614-8500.
It has been determined that publication of this CFR part removal for public comment is impracticable, unnecessary, and contrary to public interest since it is based on removing the Air Force's internal policies and procedures that are publically available on the Air Force's website.
The Department of the Air Force's internal guidance concerning the implementation of the FOIA within the Department of the Air Force will continue to be published in Air Force Manual 33-302 (available at
This rule is one of 14 separate DoD FOIA rules. With the finalization of the DoD-level FOIA rule at 32 CFR part 286, the Department is eliminating the need for this separate FOIA rule and reducing costs to the public as explained in the preamble of the DoD-level FOIA rule published at 83 FR 5196-5197.
This rule is not significant under Executive Order (E.O.) 12866, “Regulatory Planning and Review,” therefore, E.O. 13771, “Reducing Regulation and Controlling Regulatory Costs” does not apply.
Freedom of information.
Coast Guard, DHS.
Temporary final rule.
The Coast Guard is establishing special local regulations for certain waters of the Tred Avon River. This action is necessary to provide for the safety of life on these navigable waters located between Bellevue, MD, and Oxford, MD, during a swim event on June 9, 2018. If necessary, due to inclement weather, the event will be rescheduled to June 10, 2018. This action will prohibit persons and vessels from being in the regulated area unless authorized by the Captain of the Port Maryland—National Capital Region or Coast Guard Patrol Commander.
This rule is effective from 8:30 a.m. on June 9, 2018 through 11 a.m. on June 10, 2018.
To view documents mentioned in this preamble as being available in the docket, go to
If you have questions on this rule, call or email Mr. Ronald Houck, U.S. Coast Guard Sector Maryland—National Capital Region; telephone 410-576-2674, email
On June 13, 2017, Charcot-Marie-Tooth Association of Trappe, MD, notified the Coast Guard that from 9:15 a.m. until 10:15 a.m. on June 9, 2018, and if necessary, due to inclement weather, from 9:15 a.m. until 10:15 a.m. on June 10, 2018, it will be conducting the swim portion of the Oxford Biathlon in the Tred Avon River that starts at Bellevue, MD and finishes at Oxford, MD. In response, on April 4, 2018, the Coast Guard published a notice of proposed rulemaking (NPRM) entitled “Special Local Regulation; Tred Avon River, between Bellevue, MD and Oxford, MD” (83 FR 14381). There we stated why we issued the NPRM, and invited comments on our proposed regulatory action related to this fireworks display. During the comment period that ended May 4, 2018, we received one comment.
Under 5 U.S.C. 553(d)(3), the Coast Guard finds that good cause exists for making this rule effective less than 30 days after publication in the
The Coast Guard is issuing this rule under authority in 33 U.S.C. 1233, which authorizes the Coast Guard to establish and define special local regulations. The Captain of the Port (COTP) Maryland—National Capital Region has determined that potential hazards associated with the swim would be a safety concern for anyone intending to operate within certain waters of the Tred Avon River between Bellevue, MD, and Oxford, MD. The purpose of this rulemaking is to protect event participants, spectators and transiting vessels on specified waters of the Tred Avon River before, during, and after the scheduled event.
As noted above, we received one comment on our NPRM published April 4, 2018. The comment addressed issues not related to this rulemaking. Therefore, there are no substantive changes in the regulatory text of this rule from the proposed rule in the NPRM.
This rule establishes a special local regulation to be enforced from 8:30 a.m. until 11 a.m. on June 9, 2018, and if necessary, due to inclement weather, from 8:30 a.m. until 11 a.m. on June 10, 2018. The regulated area covers all navigable waters of the Tred Avon River, from shoreline to shoreline, within an area bounded on the east by a line drawn from latitude 38°42′25″ N, longitude 076°10′45″ W, thence south to latitude 38°41′37″ N, longitude 076°10′26″ W, and bounded on the west by a line drawn from latitude 38°41′58″ N, longitude 076°11′04″ W, thence south to latitude 38°41′25″ N, longitude 076°10′49″ W, thence east to latitude 38°41′25″ N, longitude 076°10′30″ W, located at Oxford, MD. The enforcement and duration of the regulated area is intended to ensure the safety of event participants and vessels within the specified navigable waters before, during, and after the 9:15 a.m. to 10:15 a.m. swim. Except for Oxford Biathlon participants, no vessel or person will be permitted to enter the regulated area without obtaining permission from the COTP Maryland—National Capital Region or Coast Guard Patrol Commander.
We developed this rule after considering numerous statutes and Executive orders related to rulemaking. Below we summarize our analyses based on a number of these statutes and Executive orders, and we discuss First Amendment rights of protestors.
Executive Orders 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. Executive Order 13771 directs agencies to control regulatory costs through a budgeting process. This rule has not been designated a “significant regulatory action,” under Executive Order 12866. Accordingly, this rule has not been reviewed by the Office of Management and Budget (OMB), and pursuant to OMB guidance it is exempt from the requirements of Executive Order 13771.
This regulatory action determination is based on the size and duration of the regulated area, which would impact a small designated area of the Tred Avon River for 2
The Regulatory Flexibility Act of 1980, 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 rule will not have a significant economic impact on a substantial number of small entities.
While some owners or operators of vessels intending to transit the regulated area may be small entities, for the reasons stated in section V.A above, this rule will not have a significant economic impact on any vessel owner or operator.
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 rule. If the rule would affect your small business, organization, or governmental jurisdiction and you have questions concerning its provisions or options for compliance, please contact the person listed in the
Small businesses may send comments on the actions of Federal employees who enforce, or otherwise determine compliance with, Federal regulations to the Small Business and Agriculture Regulatory Enforcement Ombudsman and the Regional Small Business Regulatory Fairness Boards. The Ombudsman evaluates these actions annually and rates each agency's responsiveness to small business. If you wish to comment on actions by employees of the Coast Guard, call 1-888-REG-FAIR (1-888-734-3247). The Coast Guard will not retaliate against
This rule will not call for a 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 rule under that Order and have determined that it is consistent with the fundamental federalism principles and preemption requirements described in Executive Order 13132.
Also, this rule does not have tribal implications under Executive Order 13175, Consultation and Coordination with Indian Tribal Governments, because it does 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 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 rule will not result in such an expenditure, we do discuss the effects of this rule elsewhere in this preamble.
We have analyzed this rule under Department of Homeland Security Directive 023-01, which guides the Coast Guard in complying with the National Environmental Policy Act of 1969 (42 U.S.C. 4321-4370f), and have determined that this action is one of a category of actions that do not individually or cumulatively have a significant effect on the human environment. This rule involves implementation of regulations within 33 CFR part 100 applicable to organized marine events on the navigable waters of the United States that could negatively impact the safety of waterway users and shore side activities in the event area lasting 2
The Coast Guard respects the First Amendment rights of protesters. Protesters are asked to contact the person listed in the
Marine safety, Navigation (water), Reporting and recordkeeping requirements, Waterways.
For the reasons discussed in the preamble, the Coast Guard amends 33 CFR part 100 as follows:
33 U.S.C. 1233; 33 CFR 1.05-1.
(a)
(2)
(3)
(4)
(b)
(c)
(2) Except for participants and vessels already at berth, all persons and vessels within the regulated area at the time it is activated are to depart the regulated area.
(3) Persons and vessels desiring to transit, moor, or anchor within the regulated area must obtain authorization from the COTP Maryland—National Capital Region or Coast Guard Patrol Commander. During the enforcement period, persons or vessel operators may request permission to transit, moor, or anchor within the regulated area from the Coast Guard Patrol Commander on Marine Band Radio, VHF-FM channel 16 (156.8 MHz). The Coast Guard Patrol Commander and official patrol vessels enforcing this regulated area can be contacted on marine band radio VHF-FM channel 16 (156.8 MHz) and channel 22A (157.1 MHz).
(4) The Coast Guard will publish a notice in the Fifth Coast Guard District Local Notice to Mariners and issue a marine information broadcast on VHF-FM marine band radio.
(d)
(e)
Coast Guard, DHS.
Notice of deviation from drawbridge regulation.
The Coast Guard has issued a temporary deviation from the operating schedule that governs the Burnside Bridge across the Willamette River, mile 12.4, at Portland, OR. The deviation is necessary to accommodate bridge repairs and upgrades. This deviation allows the double bascule bridge to operate one side only in single leaf mode.
This deviation is effective from 7 a.m. on July 1, 2018 to 4 p.m. on October 13, 2018.
The docket for this deviation, USCG-2018-0300 is available at
If you have questions on this temporary deviation, call or email Mr. Steven Fischer, Bridge Administrator, Thirteenth Coast Guard District; telephone 206-220-7282, email
Multnomah County, Oregon owns the Burnside Bridge, crossing the Willamette River, mile 12.4, at Portland, OR, and has requested a temporary deviation from the operating schedule. The requested deviation is to accommodate bridge repairs and upgrades. To facilitate this maintenance, the draw of the subject bridge will be authorized to operate in single leaf and open the east leaf of the span only. The bridge is also authorized to maintain the west leaf in the closed-to-navigation position to marine traffic, and reduce the vertical clearance up to ten feet. This deviation period is from 7 a.m. on July 1, 2018 to 4 p.m. on October 13, 2018.
The Burnside Bridge provides a vertical clearance of 41 feet in the closed-to-navigation position referenced to Columbia River Datum 0.0, and the west leaf will be reduced to 31 feet with scaffolding installed. The horizontal clearance for an east leaf opening will be 100 feet. The normal operating schedule is in 33 CFR 117.897. Waterway usage on this part of the Willamette River includes vessels ranging from commercial tug and barge to small pleasure craft. The Coast Guard contacted all known users of the Willamette River for comment, and we received no objections for this deviation.
Vessels able to pass through the bridge in the closed-to-navigation position may do so at any time. The bridge will be able to open the east side of the span only for emergencies, and there is no immediate alternate route for vessels to pass. The Coast Guard will inform the users of the waterway, through our Local and Broadcast Notices to Mariners, of the change in operating schedule for the bridges so that vessels can arrange their transits to minimize any impact caused by the temporary deviation.
In accordance with 33 CFR 117.35(e), the drawbridge must return to its regular operating schedules immediately at the end of the effective period of this temporary deviation. This deviation from the operating regulations is authorized under 33 CFR 117.35.
Coast Guard, DHS.
Notice of deviation from drawbridge regulation.
The Coast Guard has issued a temporary deviation from the operating schedule that governs the Hutchinson River Parkway Bridge across the Hutchinson River, mile 0.9 at New York, New York. This deviation is necessary to allow the bridge to remain in the closed-to-navigation position to facilitate structural repairs.
This deviation is effective from 12:01 a.m. on July 16, 2018 to 11:59 p.m. on September 16, 2018.
The docket for this deviation, USCG-2018-0440 is available at
If you have questions on this temporary deviation, call or email Judy Leung-Yee, Bridge Management Specialist, First District Bridge Branch, U.S. Coast Guard; telephone 212-514-4336, email
The New York City Department of Transportation, the bridge owner, requested a temporary deviation from the normal operating schedule to facilitate structural repairs. The Hutchinson River Parkway Bridge, across the Hutchinson River, mile 0.9 at New York, New York has a vertical clearance of 30 feet at mean high water and 38 feet at mean low water in the closed position. The existing drawbridge operating regulations are listed at 33 CFR 117.793(b).
Under this temporary deviation, from 12:01 a.m. on July 16, 2018 to 11:59 p.m. on September 16, 2018 the draw of the Hutchinson River Parkway Bridge will be closed to navigation for a period not to exceed 14 days; the draw will then open for vessels in accordance with established operating regulations for a period not to exceed another 7 days, after which the cycle will repeat.
The waterway is transited by commercial and recreational traffic. The bridge owner notified known commercial vessel operators that transit the waterway and there were no objections to this temporary deviation. Vessels able to pass under the bridge in the closed position may do so at any time. The bridge will not be able to open for emergencies and there is no immediate alternate route for vessels to pass.
The Coast Guard will also inform the users of the waterways through our Local and Broadcast Notices to Mariners of the change in operating schedule for the bridge so that vessel operators can arrange their transits to minimize any
In accordance with 33 CFR 117.35(e), the drawbridge must return to its regular operating schedule immediately at the end of the effective period of this temporary deviation. This deviation from the operating regulations is authorized under 33 CFR 117.35.
Coast Guard, DHS.
Notice of deviation from drawbridge regulation.
The Coast Guard has issued a temporary deviation from the operating schedule that governs the twin, SR 529 Highway Bridge, north bound, across Steamboat Slough, mile 1.2, near Marysville, WA. The deviation is necessary to accommodate painting and preservation. This deviation allows the bridge to remain in the closed-to-navigation position during the maintenance period to allow safe movement of the work crew.
This deviation is effective from 12:01 a.m. on July 2, 2018 to 11:59 p.m. on September 30, 2018.
The docket for this deviation, USCG-2018-0428 is available at
If you have questions on this temporary deviation, call or email Mr. Steven Fischer, Bridge Administrator, Thirteenth Coast Guard District; telephone 206-220-7282, email
The Washington State Department of Transportation, the bridge owner, has requested that the twin, SR 529, Highway Bridge, north bound, across Steamboat Slough, mile 1.2, near Marysville, WA, remain in the closed-to-navigation position, which will reduce the lift span's vertical clearance by three feet. This request is to facilitate safe, uninterrupted bridge work for painting and preservation. The SR 529 highway bridge across Steamboat Slough, mile 1.2, provides 10 feet of vertical clearance above mean high water elevation while in the closed-to-navigation position; and this bridge operates in accordance with 33 CFR 117.1059(g).
The twin, SR 529, Highway Bridge, north bound, across Steamboat Slough, mile 1.2, is authorized to remain in the closed-to navigation position, and need not open for maritime traffic from 12:01 a.m. on July 2, 2018 to 11:59 p.m. on September 30, 2018. The subject bridge's lift span vertical clearance is also authorized to be reduced from ten feet to seven feet except for a 50 foot wide section that shall not be reduced for maritime passage. The bridge shall operate in accordance to 33 CFR 117.1059(g) at all other times.
Waterway usage on this part of the Snohomish River and Steamboat Slough includes vessels ranging from commercial tug and barge to small pleasure craft. Vessels able to pass under the subject bridge in the closed-to-navigation position may do so at any time. The subject bridge will not be able to open for vessels engaged in emergency response during the closure period. An alternate route for vessels to pass is available through Ebey Slough and Union Slough near the entrance of Steamboat Slough at high tide. The Coast Guard will also inform the users of the waterways through our Local and Broadcast Notices to Mariners of the change in operating schedule for the bridges so that vessels can arrange their transits to minimize any impact caused by the temporary deviation.
In accordance with 33 CFR 117.35(e), the drawbridge must return to the regular operating schedule immediately at the end of the effective period of this temporary deviation. This deviation from the operating regulations is authorized under 33 CFR 117.35.
Coast Guard, DHS.
Temporary final rule.
The Coast Guard is establishing a temporary safety zone for the navigable waters of the Ohio River from mile marker 27.8 to mile marker 28.2 near the Vanport Highway Bridge. The safety zone is necessary to protect personnel, vessels, and the marine environment from potential hazards created by a cargo movement near the Vanport Highway Bridge in Vanport, PA. Entry of vessels or persons into this zone is prohibited unless authorized by the Captain of the Port Marine Safety Unit Pittsburgh or a designated representative.
This rule is effective without actual notice from June 7, 2018 through 6 p.m. on June 16, 2018. For the purposes of enforcement, actual notice will be used from 8 a.m. on June 2, 2018 through June 7, 2018.
To view documents mentioned in this preamble as being available in the docket, go to
If you have questions on this rule, call or email Petty Officer Jennifer Haggins, Marine Safety Unit Pittsburgh, U.S. Coast Guard, at telephone 412-221-0807, email
The Coast Guard is issuing this temporary rule without prior notice and opportunity to comment pursuant to
Under 5 U.S.C. 553(d)(3), the Coast Guard finds that good cause exists for making this rule effective less than 30 days after publication in the
The Coast Guard is issuing this rule under authority in 33 U.S.C. 1231. The Captain of the Port Marine Safety Unit Pittsburgh (COTP) has determined that potential hazards associated with a cargo movement operation on a day between June 2, 2018 and June 16, 2018 will be a safety concern for anyone within a half-mile stretch of the Ohio River. This rule is necessary to protect personnel, vessels, and the marine environment in the navigable waters before, during, and after the cargo movement.
This rule establishes a temporary safety zone from 8 a.m. on June 2, 2018 through 6 p.m. on June 16, 2018 for all navigable waters of the Ohio River from mile marker 27.8 to mile marker 28.2. Entry into this safety zone during the enforcement period is prohibited, unless authorized by the COTP or a designated representative. Subject to the cargo delivery intervals and potential inclement weather, the enforcement period will be 30 minutes prior to, during, and 1 hour after any cargo movement near the Vanport Highway Bridge. The Coast Guard was informed that the operation would take place during daylight hours only and last approximately 4 hours. A safety vessel will coordinate all vessel traffic during the enforcement period. The COTP or a designated representative will inform the public through Broadcast Notices to Mariners (BNMs), Local Notices to Mariners (LNMs), and/or Marine Safety Information Bulletins (MSIBs), or through other means of public notice as appropriate at least 3 hours in advance of the enforcement period.
The duration of the zone is intended to protect personnel, vessels, and the marine environment in these navigable waters during cargo movement operations. No vessel or person will be permitted to enter the safety zone without obtaining permission from the COTP or a designated representative. A designated representative is a commissioned, warrant, or petty officer of the U.S. Coast Guard assigned to units under the operational control of Marine Safety Unit Pittsburgh. They may be contacted on VHF-FM Channel 16 or 67. Persons and vessels permitted to enter this regulated area must transit at their slowest safe speed and comply with all lawful directions issued by the COTP or the designated representative. The COTP or a designated representative will inform the public of the effective period for the safety zone as well as any changes in the dates and times of enforcement through Local Notice to Mariners (LNMs), Broadcast Notices to Mariners (BNMs), and/or Marine Safety Information Bulletins (MSIBs) as appropriate.
We developed this rule after considering numerous statutes and Executive orders related to rulemaking. Below we summarize our analyses based on a number of these statutes and Executive orders, and we discuss First Amendment rights of protestors.
Executive Orders 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. Executive Order 13771 directs agencies to control regulatory costs through a budgeting process. This rule has not been designated a “significant regulatory action,” under Executive Order 12866. Accordingly, this rule has not been reviewed by the Office of Management and Budget (OMB), and pursuant to OMB guidance it is exempt from the requirements of Executive Order 13771.
This regulatory action determination is based on the size, location, duration, and time-of-year of the safety zone. This safety zone will be enforced for a period of four hours on one day on less than a half mile of the Ohio River. The Coast Guard will issue LNMs and BNMs via VHF-FM marine channel 16 about the temporary safety zone, and the rule allows vessels to seek permission from the COTP or a designated representative to enter the safety zone.
The Regulatory Flexibility Act of 1980, 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 rule will not have a significant economic impact on a substantial number of small entities.
While some owners or operators of vessels intending to transit the safety zone may be small entities, for the reasons stated in section V.A above, this rule will not have a significant economic impact on any vessel owner or operator.
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 rule. If the rule would affect your small business, organization, or governmental jurisdiction and you have questions concerning its provisions or options for compliance, please contact the person listed in the
Small businesses may send comments on the actions of Federal employees who enforce, or otherwise determine compliance with, Federal regulations to the Small Business and Agriculture Regulatory Enforcement Ombudsman and the Regional Small Business Regulatory Fairness Boards. The Ombudsman evaluates these actions annually and rates each agency's responsiveness to small business. If you wish to comment on actions by employees of the Coast Guard, call 1-888-REG-FAIR (1-888-734-3247). The Coast Guard will not retaliate against small entities that question or complain about this rule or any policy or action of the Coast Guard.
This rule will not call for a 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 rule under that Order and have determined that it is consistent with the fundamental federalism principles and preemption requirements described in Executive Order 13132.
Also, this rule does not have tribal implications under Executive Order 13175, Consultation and Coordination with Indian Tribal Governments, because it does 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 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 rule will not result in such an expenditure, we do discuss the effects of this rule elsewhere in this preamble.
We have analyzed this rule under Department of Homeland Security Directive 023-01 and Commandant Instruction M16475.1D, which guide the Coast Guard in complying with the National Environmental Policy Act of 1969 (42 U.S.C. 4321-4370f), and have determined that this action is one of a category of actions that do not individually or cumulatively have a significant effect on the human environment. This rule involves a temporary safety zone lasting only 4 hours that prohibits entry on a half-mile stretch of the Ohio River for 4 hours on one day from June 2, 2016 through June 16, 2018. It is categorically excluded from further review under paragraph L60(a) of Appendix A, Table 1 of DHS Instruction Manual 023-01-001-01, Rev. 01. A Record of Environmental Consideration supporting this determination is available in the docket where indicated under
The Coast Guard respects the First Amendment rights of protesters. Protesters are asked to contact the person listed in the
Marine safety, Navigation (water), Reporting and recordkeeping requirements, Security measures, Waterways.
For the reasons discussed in the preamble, the Coast Guard amends 33 CFR part 165 as follows:
33 U.S.C. 1231; 50 U.S.C. 191; 33 CFR 1.05-1, 6.04-1, 6.04-6, and 160.5; Department of Homeland Security Delegation No. 0170.1.
(a)
(b)
(c)
(d)
(2) Vessels requiring entry into this safety zone must request permission from the COTP or a designated representative. They may be contacted on VHF-FM Channel 16 or 67.
(3) All persons and vessels permitted to enter this safety zone must transit at the slowest safe speed and comply with all lawful directions issued by the COTP or the designated representative.
(e)
Coast Guard, DHS.
Temporary final rule.
The Coast Guard is establishing a temporary safety zone for certain waters of the Cuyahoga River during the Blazing Paddles Stand Up Paddleboard Race. This safety zone is intended to restrict vessels from a portion of the Cuyahoga River during the Blazing Paddles Stand Up Paddleboard Race. This temporary safety zone is necessary to protect mariners and racers from the navigational hazards associated with the Stand Up Paddleboard Race.
This rule is effective from 8:30 a.m. through 11:30 a.m. on June 23, 2018.
To view documents mentioned in this preamble as being
If you have questions on this rule, call or email LT Michael Collet, Chief of Waterways Management, U.S. Coast Guard Sector Buffalo; telephone 716-843-9322, email
On April 20, 2018 the Coast Guard published a Notice of Proposed Rulemaking (NPRM) titled Blazing Paddles 2018 SUP Race; Cuyahoga River, Cleveland, OH § 165.T09-0242. In that we discussed why we issued the NPRM and invited comments on our proposed regulatory action related to this Standup Paddleboard race. The comment period ended May 30, 2018; we received one comment relating to the event. The comment makes note of a Memorandum of Understanding that had been agreed upon by the Lake Carriers' Association and Share the River. The Lake Carriers Association have no objection to the proposed rule. There was nothing further that needed to be addressed regarding the Temporary Final Rule.
Under 5 U.S.C. 553(d)(3), the Coast Guard finds that good cause exists for making this rule effective less than 30 days after publication in the
The Coast Guard is issuing this rule under authority in 33 U.S.C. 1231. The Captain of the Port Buffalo (COTP) has determined that a large-scale paddle craft event on a navigable waterway will pose a significant risk to participants and the boating public. This rule is needed to protect personnel, vessels, and the marine environment in the navigable waters within the safety zone while the Blazing Paddles Race is happening.
As noted above, we received one comment on our NPRM published April 30, 2018, and there was no objection to the proposed rule. There are no changes in the regulatory text of this rule from the proposed rule in the NPRM.
This rule establishes a safety zone from 8:30 a.m. through 11:30 a.m. on June 23, 2018. The safety zone will cover all navigable waters at the start point at position 41°29′36″ N and 081°42′13″ W to the turnaround point at position 41°28′52″ N and 081°40′33″ W on the Cuyahoga River in Cleveland, OH. The duration of the zone is intended to ensure the safety of vessels and these navigable waters before, during, and after the scheduled 9 to 11 a.m. Paddleboard Race.
Entry into, transiting, or anchoring within the safety zone is prohibited unless authorized by the COTP Buffalo or his designated on-scene representative. The COTP or his designated on-scene representative may be contacted via VHF Channel 16.
We developed this rule after considering numerous statutes and Executive Orders related to rulemaking. Below we summarize our analyses based on a number of these statutes and Executive Orders, and we discuss First Amendment rights of protestors.
Executive Orders 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. Executive Order 13771 directs agencies to control regulatory costs through a budgeting process. This rule has not been designated a “significant regulatory action,” under Executive Order 12866. Accordingly, this rule has not been reviewed by the Office of Management and Budget (OMB), and pursuant to OMB guidance it is exempt from the requirements of Executive Order 13771.
This regulatory action determination is based on the characteristics of the safety zone. The safety zone created by this rule will be relatively small and is designed to minimize its impact on navigable waters. Furthermore, the safety zone has been designed to allow vessels to transit around it. In addition, the safety zone will designate times when races are not occurring; allowing vessels to travel through the safety zone. Thus, restrictions on vessel movement within that particular area are expected to be minimal. Under certain conditions, moreover, vessels may still transit through the safety zone when permitted by the COTP.
The Regulatory Flexibility Act of 1980, 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 received 00 comments from the Small Business Administration on this rulemaking. The Coast Guard certifies under 5 U.S.C. 605(b) that this rule will not have a significant economic impact on a substantial number of small entities.
While some owners or operators of vessels intending to transit the safety zone may be small entities, for the reasons stated in section V.A above, this rule will not have a significant economic impact on any vessel owner or operator.
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 rule. If the rule would affect your small business, organization, or governmental jurisdiction and you have questions concerning its provisions or options for compliance, please contact the person listed in the
Small businesses may send comments on the actions of Federal employees who enforce, or otherwise determine compliance with, Federal regulations to the Small Business and Agriculture Regulatory Enforcement Ombudsman and the Regional Small Business Regulatory Fairness Boards. The Ombudsman evaluates these actions annually and rates each agency's responsiveness to small business. If you wish to comment on actions by employees of the Coast Guard, call 1-888-REG-FAIR (1-888-734-3247). The Coast Guard will not retaliate against small entities that question or complain about this rule or any policy or action of the Coast Guard.
This rule will not call for a new collection of information under the
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 rule under that Order and have determined that it is consistent with the fundamental federalism principles and preemption requirements described in Executive Order 13132.
Also, this rule does not have tribal implications under Executive Order 13175, Consultation and Coordination with Indian Tribal Governments, because it does 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 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 rule will not result in such an expenditure, we do discuss the effects of this rule elsewhere in this preamble.
We have analyzed this rule under Department of Homeland Security Management Directive 023-01 and Commandant Instruction M16475.lD, which guide the Coast Guard in complying with the National Environmental Policy Act of 1969 (42 U.S.C. 4321-4370f), and have determined that this action is one of a category of actions that do not individually or cumulatively have a significant effect on the human environment. This rule involves establishment of a safety zone. It is categorically excluded from further review under paragraph L60(a) of Appendix A, Table 1 of DHS Instruction Manual 023-01-001-01, Rev. 01. A Record of Environmental Consideration supporting this determination is available in the docket where indicated under
The Coast Guard respects the First Amendment rights of protesters. Protesters are asked to contact the person listed in the
Harbors, Marine safety, Navigation (water), Reporting and record keeping requirements, Security measures, Waterways.
For the reasons discussed in the preamble, the Coast Guard amends 33 CFR part 165 as follows:
33 U.S.C. 1231; 50 U.S.C. 191; 33 CFR 1.05-1, 6.04-1, 6.04-6, and 160.5; Department of Homeland Security Delegation No. 0170.1.
(a)
(b)
(c)
(2) This safety zone is closed to all vessel traffic, except as may be permitted by the COTP or his designated on-scene representative.
(3) The “on-scene representative” of the COTP is any Coast Guard commissioned, warrant or petty officer who has been designated by the COTP to act on his behalf.
(4) Vessel operators desiring to enter or operate within the safety zone must contact the COTP Buffalo or his on-scene representative to obtain permission to do so. The COTP or his on-scene representative may be contacted via VHF Channel 16 or at (716) 843-9322. Vessel operators given permission to enter or operate in the safety zone must comply with all directions given to them by the COTP or his on-scene representative.
Environmental Protection Agency (EPA).
Final rule.
This regulation establishes tolerances for residues of acequinocyl in or on guava and the tropical and subtropical, small fruit, inedible peel, subgroup 24A. Interregional Research Project Number 4 (IR-4) requested these tolerances under the Federal Food, Drug, and Cosmetic Act (FFDCA).
This regulation is effective June 7, 2018. Objections and requests for hearings must be received on or before August 6, 2018, and must be filed in accordance with the instructions provided in 40 CFR part 178 (see also Unit I.C. of the
The docket for this action, identified by docket identification (ID) number EPA-HQ-OPP-2017-0376, is available at
Michael Goodis, Registration Division (7505P), Office of Pesticide Programs, Environmental Protection Agency, 1200
You may be potentially affected by this action if you are an agricultural producer, food manufacturer, or pesticide manufacturer. The following list of North American Industrial Classification System (NAICS) codes is not intended to be exhaustive, but rather provides a guide to help readers determine whether this document applies to them. Potentially affected entities may include:
• Crop production (NAICS code 111).
• Animal production (NAICS code 112).
• Food manufacturing (NAICS code 311).
• Pesticide manufacturing (NAICS code 32532).
You may access a frequently updated electronic version of EPA's tolerance regulations at 40 CFR part 180 through the Government Printing Office's e-CFR site at
Under FFDCA section 408(g), 21 U.S.C. 346a, any person may file an objection to any aspect of this regulation and may also request a hearing on those objections. You must file your objection or request a hearing on this regulation in accordance with the instructions provided in 40 CFR part 178. To ensure proper receipt by EPA, you must identify docket ID number EPA-HQ-OPP-2017-0376 in the subject line on the first page of your submission. All objections and requests for a hearing must be in writing, and must be received by the Hearing Clerk on or before August 6, 2018. Addresses for mail and hand delivery of objections and hearing requests are provided in 40 CFR 178.25(b).
In addition to filing an objection or hearing request with the Hearing Clerk as described in 40 CFR part 178, please submit a copy of the filing (excluding any Confidential Business Information (CBI)) for inclusion in the public docket. Information not marked confidential pursuant to 40 CFR part 2 may be disclosed publicly by EPA without prior notice. Submit the non-CBI copy of your objection or hearing request, identified by docket ID number EPA-HQ-OPP-2017-0376, by one of the following methods:
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•
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Additional instructions on commenting or visiting the docket, along with more information about dockets generally, is available at
In the
EPA is establishing the requested tolerances with additional significant figures in conformity with Agency policy.
Section 408(b)(2)(A)(i) of FFDCA allows EPA to establish a tolerance (the legal limit for a pesticide chemical residue in or on a food) only if EPA determines that the tolerance is “safe.” Section 408(b)(2)(A)(ii) of FFDCA defines “safe” to mean that “there is a reasonable certainty that no harm will result from aggregate exposure to the pesticide chemical residue, including all anticipated dietary exposures and all other exposures for which there is reliable information.” This includes exposure through drinking water and in residential settings, but does not include occupational exposure. Section 408(b)(2)(C) of FFDCA requires EPA to give special consideration to exposure of infants and children to the pesticide chemical residue in establishing a tolerance and to “ensure that there is a reasonable certainty that no harm will result to infants and children from aggregate exposure to the pesticide chemical residue. . . .”
Consistent with FFDCA section 408(b)(2)(D), and the factors specified in FFDCA section 408(b)(2)(D), EPA has reviewed the available scientific data and other relevant information in support of this action. EPA has sufficient data to assess the hazards of and to make a determination on aggregate exposure for acequinocyl including exposure resulting from the tolerances established by this action. EPA's assessment of exposures and risks associated with acequinocyl follows.
EPA has evaluated the available toxicity data and considered its validity, completeness, and reliability as well as the relationship of the results of the studies to human risk. EPA has also considered available information concerning the variability of the sensitivities of major identifiable subgroups of consumers, including infants and children.
The target organs of acequinocyl are the liver (hepatocyte vacuolization, brown pigmented cells and perivascular inflammatory cells in liver) and hematopoietic system (hemorrhage, increased clotting factor times and increased platelet counts). There was no evidence of neurotoxicity or immunotoxicity. There was no evidence of carcinogenic potential in either the rat or mouse and there was no concern for genotoxicity or mutagenicity.
In rats and rabbits, there was no evidence of increased quantitative or qualitative fetal susceptibility. For both species, maternal effects (clinical signs and gross necropsy findings) were observed at similar or lower doses than those producing fetal effects. In rabbits, there were increased incidences of late resorptions at the highest dose tested. Since it is unknown whether resorptions occurred from toxicity to maternal animals or the fetuses, the resorptions are considered maternal and developmental adverse effects. In the rat
Specific information on the studies received and the nature of the adverse effects caused by acequinocyl as well as the no-observed-adverse-effect-level (NOAEL) and the lowest-observed-adverse-effect-level (LOAEL) from the toxicity studies can be found at
Once a pesticide's toxicological profile is determined, EPA identifies toxicological points of departure (POD) and levels of concern to use in evaluating the risk posed by human exposure to the pesticide. For hazards that have a threshold below which there is no appreciable risk, the toxicological POD is used as the basis for derivation of reference values for risk assessment. PODs are developed based on a careful analysis of the doses in each toxicological study to determine the dose at which no adverse effects are observed (the NOAEL) and the lowest dose at which adverse effects of concern are identified (the LOAEL). Uncertainty/safety factors are used in conjunction with the POD to calculate a safe exposure level—generally referred to as a population-adjusted dose (PAD) or a reference dose (RfD)—and a safe margin of exposure (MOE). For non-threshold risks, the Agency assumes that any amount of exposure will lead to some degree of risk. Thus, the Agency estimates risk in terms of the probability of an occurrence of the adverse effect expected in a lifetime. For more information on the general principles EPA uses in risk characterization and a complete description of the risk assessment process, see
A summary of the toxicological endpoints for acequinocyl used for human risk assessment is discussed in Unit III.B. of the final rule published in the
1.
i.
Such effects were identified for acequinocyl. In estimating acute dietary exposure, EPA used food consumption information from the United States Department of Agriculture (USDA) 2003-2008 National Health and Nutrition Examination Survey, What We Eat in America, (NHANES/WWEIA). As to residue levels in food, EPA assumed tolerance-level residues and 100 percent crop treated (PCT) for all proposed and registered uses.
ii.
iii.
iv.
2.
Based on the Pesticide Root Zone Model/Exposure Analysis Modeling System (PRZM/EXAMS), Provisional Cranberry Model, and Screening Concentration in Ground Water (SCI-GROW) Model, the estimated drinking water concentrations (EDWCs) of acequinocyl for acute exposures are estimated to be 6.69 parts per billion (ppb) for surface water and 3.6 × 10
Modeled estimates of drinking water concentrations were directly entered into the dietary exposure model. For both the acute and chronic dietary risk assessments, the water concentration value of 6.69 ppb was used to assess the contribution to drinking water.
3.
Acequinocyl is currently registered for the following uses that could result in residential exposures: Use on ornamentals for landscapes, gardens, and trees. EPA assessed residential exposure using the following assumptions: Residential handler exposures are not expected since all registered acequinocyl product labels with residential use sites (
Only short-term post-application dermal exposure is anticipated for the registered residential uses. The quantitative exposure/risk assessment for residential post-application exposures assessed dermal exposures to adults for activities associated with gardening, dermal exposures to children (6 to <11 years old) for activities associated with playing in and around gardens and gardening, dermal exposures to adults associated with handling trees and retail plants, and dermal exposures to children (6 to <11 years old) for activities associated with playing in and around trees and retail plants.
Further information regarding EPA standard assumptions and generic inputs for residential exposures may be found at
4.
EPA has not found acequinocyl to share a common mechanism of toxicity with any other substances, and acequinocyl does not appear to produce a toxic metabolite produced by other substances. For the purposes of this tolerance action, therefore, EPA has assumed that acequinocyl does not have a common mechanism of toxicity with other substances. For information regarding EPA's efforts to determine which chemicals have a common mechanism of toxicity and to evaluate the cumulative effects of such chemicals, see EPA's website at
1.
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i. The effects in pups are well characterized with a clear NOAEL and
ii. The effects are protected for by the selected endpoints.
Therefore, there are no residual uncertainties for pre-/post-natal toxicity. Additionally, hematological parameters were not measured for the parental animals in the two-generation reproductive study; however, hematological effects were observed in adult animals in other oral rat studies at the same doses eliciting offspring effects. Therefore, considering the offspring findings in the two-generation reproductive toxicity study in context with the full toxicological database, there is no concern for offspring susceptibility since parental toxicity would be anticipated at the same dose as offspring effects.
3.
i. The toxicity database for acequinocyl is complete.
ii. There is no indication that acequinocyl is a neurotoxic chemical and there is no need for a developmental neurotoxicity study or additional UFs to account for neurotoxicity.
iii. There is no evidence of an increased quantitative or qualitative fetal susceptibility in rats or rabbits, but in isolation there was evidence of increased quantitative offspring susceptibility in the two-generation reproductive study. However, the concern is low for the reasons outlined above in section III.D.2.
iv. There are no residual uncertainties identified in the exposure databases. The dietary food exposure assessments were performed based on 100 PCT and tolerance-level residues. EPA made conservative (protective) assumptions in the ground and surface water modeling used to assess exposure to acequinocyl in drinking water. EPA used similarly conservative assumptions to assess post-application exposure of children. These assessments will not underestimate the exposure and risks posed by acequinocyl.
EPA determines whether acute and chronic dietary pesticide exposures are safe by comparing aggregate exposure estimates to the acute PAD (aPAD) and chronic PAD (cPAD). For linear cancer risks, EPA calculates the lifetime probability of acquiring cancer given the estimated aggregate exposure. Short-, intermediate-, and chronic-term risks are evaluated by comparing the estimated aggregate food, water, and residential exposure to the appropriate PODs to ensure that an adequate MOE exists.
1.
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Using the exposure assumptions described in this unit for short-term exposures, EPA has concluded the combined short-term food, water, and residential exposures result in aggregate MOEs of 1140 for adults and 910 for children 6-11 years old. Because EPA's level of concern for acequinocyl is a MOE of 100 or below, these MOEs are not of concern.
4.
An intermediate-term adverse effect was identified; however, acequinocyl is not registered for any use patterns that would result in intermediate-term residential exposure. Intermediate-term risk is assessed based on intermediate-term residential exposure plus chronic dietary exposure. Because there is no intermediate-term residential exposure and chronic dietary exposure has already been assessed under the appropriately protective cPAD (which is at least as protective as the POD used to assess intermediate-term risk), no further assessment of intermediate-term risk is necessary, and EPA relies on the chronic dietary risk assessment for evaluating intermediate-term risk for acequinocyl.
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6.
Adequate enforcement methodology (two high-performance liquid chromatography methods with tandem mass-spectroscopy detection (HPLC/MS/MS) for determining residues in/on fruit and nut commodities (Morse Methods Meth-133, Revision #4 and Meth-135, Revision #3)) is available to enforce the tolerance expression.
The method may be requested from: Chief, Analytical Chemistry Branch, Environmental Science Center, 701 Mapes Rd., Ft. Meade, MD 20755-5350; telephone number: (410) 305-2905; email address:
In making its tolerance decisions, EPA seeks to harmonize U.S. tolerances with international standards whenever possible, consistent with U.S. food safety standards and agricultural practices. EPA considers the international maximum residue limits (MRLs) established by the Codex Alimentarius Commission (Codex), as required by FFDCA section 408(b)(4). The Codex Alimentarius is a joint United Nations Food and Agriculture Organization/World Health Organization food standards program, and it is recognized as an international food safety standards-setting organization in trade agreements to which the United States is a party. EPA may establish a tolerance that is different from a Codex MRL; however, FFDCA section 408(b)(4) requires that EPA explain the reasons for departing from the Codex level.
The Codex has not established any MRLs for acequinocyl on the crops cited in this document.
Therefore, tolerances are established for residues of acequinocyl, including its metabolites and degradates, in or on guava at 0.90 ppm and the tropical and subtropical, small fruit, inedible peel, subgroup 24A at 2.0 ppm.
This action establishes tolerances under FFDCA section 408(d) in response to a petition submitted to the Agency. The Office of Management and Budget (OMB) has exempted these types of actions from review under Executive Order 12866, entitled “Regulatory Planning and Review” (58 FR 51735, October 4, 1993). Because this action has been exempted from review under Executive Order 12866, this action is not subject to Executive Order 13211, entitled “Actions Concerning Regulations That Significantly Affect Energy Supply, Distribution, or Use” (66 FR 28355, May 22, 2001) or Executive Order 13045, entitled “Protection of Children from Environmental Health Risks and Safety Risks” (62 FR 19885, April 23, 1997), nor is it considered a regulatory action under Executive Order 13771, entitled “Reducing Regulations and Controlling Regulatory Costs” (82 FR 9339, February 3, 2017). This action does not contain any information collections subject to OMB approval under the Paperwork Reduction Act (PRA) (44 U.S.C. 3501
Since tolerances and exemptions that are established on the basis of a petition under FFDCA section 408(d), such as the tolerance in this final rule, do not require the issuance of a proposed rule, the requirements of the Regulatory Flexibility Act (RFA) (5 U.S.C. 601
This action directly regulates growers, food processors, food handlers, and food retailers, not States or tribes, nor does this action alter the relationships or distribution of power and responsibilities established by Congress in the preemption provisions of FFDCA section 408(n)(4). As such, the Agency has determined that this action will not have a substantial direct effect on States or tribal governments, on the relationship between the national government and the States or tribal governments, or on the distribution of power and responsibilities among the various levels of government or between the Federal Government and Indian tribes. Thus, the Agency has determined that Executive Order 13132, entitled “Federalism” (64 FR 43255, August 10, 1999) and Executive Order 13175, entitled “Consultation and Coordination with Indian Tribal Governments” (65 FR 67249, November 9, 2000) do not apply to this action. In addition, this action does not impose any enforceable duty or contain any unfunded mandate as described under Title II of the Unfunded Mandates Reform Act (UMRA) (2 U.S.C. 1501
This action does not involve any technical standards that would require Agency consideration of voluntary consensus standards pursuant to section 12(d) of the National Technology Transfer and Advancement Act (NTTAA) (15 U.S.C. 272 note).
Pursuant to the Congressional Review Act (5 U.S.C. 801
Environmental protection, Administrative practice and procedure, Agricultural commodities, Pesticides and pests, Reporting and recordkeeping requirements.
Therefore, 40 CFR chapter I is amended as follows:
21 U.S.C. 321(q), 346a and 371.
(a) * * *
Federal Motor Carrier Safety Administration (FMCSA), DOT.
Final rule; correction.
FMCSA corrects the technical corrections final rule published on May 17, 2018, that amended FMCSA regulations to make minor changes to correct inadvertent errors and omissions, remove or update obsolete references, ensure conformity with Office of the Federal Register style guidelines, and improve the clarity and consistency of certain regulatory provisions. This document corrects an amendatory instruction.
Effective June 18, 2018.
Mr. David Miller, Federal Motor Carrier Safety Administration, Regulatory Development Division, 1200 New Jersey Avenue SE, Washington, DC 20590-0001, by telephone at (202) 366-5370 or via email at
In FR Doc. 2018-10437, appearing on page 22873 in the
Federal Motor Carrier Safety Administration (FMCSA), DOT
Announcement of regulatory guidance
FMCSA announces regulatory guidance to clarify the applicability of the “Agricultural commodity” exception in the “Hours of Service (HOS) of Drivers” regulations. This regulatory guidance clarifies the exception with regard to: drivers operating unladen vehicles traveling either to pick up an agricultural commodity or returning from a delivery point; drivers engaged in trips beyond 150 air-miles from the source of the agricultural commodity; determining the “source” of agricultural commodities under the exemptions; and how the exception applies when agricultural commodities are loaded at multiple sources during a trip. This regulatory guidance is issued to ensure consistent understanding and application of the exception by motor carriers and State officials enforcing HOS rules identical to or compatible with FMCSA's requirements.
This guidance is applicable on June 7, 2018 and expires June 7, 2023.
Mr. Thomas Yager, Chief, Driver and Carrier Operations Division, Federal Motor Carrier Safety Administration, U.S. Department of Transportation, 1200 New Jersey Avenue SE, Washington, DC 20590, phone (202) 366-4325, email
To view comments, as well as documents mentioned in this preamble as being available in the docket, go to
The National Highway System Designation Act of 1995, Public Law 104-59, sec. 345, 109 Stat. 568. 613 (Nov. 28, 1995) (the Act), provided the initial exception for drivers transporting agricultural commodities or farm supplies for agricultural purposes. The Act limited the exception to a 100 air-mile radius from the source of the commodities or distribution point for the farm supplies and during the planting and harvesting seasons as determined by the applicable State.
The Safe, Accountable, Flexible, Efficient Transportation Act: A Legacy for Users (SAFETEA-LU) revised this provision, redesignated it as new section 229 of Title II of the Motor Carrier Safety Improvement Act of 1999, and defined the terms “agricultural commodity” and “farm supplies for agricultural purposes.” Public Law 109-59, sections 4115 and 4130, 119 Stat. 1144, 1726, 1743 (Aug. 10, 2005). These terms are now defined in 49 CFR 395.2.
Most recently, the statute was amended by section 32101(d) of the Moving Ahead for Progress in the 21st Century Act (MAP-21), Public Law 112-141, 126 Stat. 405, 778 (July 6, 2012). This provision revised the description of the exception's scope and extended the applicable distance from 100 air-miles to 150 air-miles from the source.
The focus of today's guidance is limited to the application of the 150 air-mile exception for the transportation of “agricultural commodities,” 49 CFR 395.1(k)(1). It does not address “farm supplies for agricultural purposes”
On December 20, 2017, FMCSA published a
Interpreted literally, the agricultural commodity exception could be read as applicable only during the period during which the commodity is being transported, and not to movements of an unladen commercial motor vehicle (CMV) either traveling to pick up a load or returning after a delivery. The Agency does not consider that view consistent with the de-regulatory purpose of the exception since applying HOS rules on these unladen trips would limit the relief that Congress intended to grant, while needlessly complicating the regulatory monitoring task that enforcement officials are asked to perform. It is unreasonable to assume that the 1995 statute intended to exempt, for example, farmers hauling soy beans from the field to an elevator, while subjecting them to the full extent of the HOS regulations during the empty return trip to the field to pick up the next load. The Agency has therefore informally advised stakeholders that both legs of a trip are covered. In the proposed guidance (Question 34), FMCSA sought to clarify how the agricultural commodity exception applies to someone driving an unladen CMV either to a source to pick up an agricultural commodity or on a return trip following delivery of an agricultural commodity. The proposed Guidance to Question 34 stated that the agricultural commodity exception (§ 395.1(k)(1)) does apply while driving unloaded to a source where an agricultural commodity will be loaded, and to an unloaded return trip after delivering an agricultural commodity, provided that the trip does not involve transporting other cargo and the sole purpose of the trip is to complete the delivery or pick up of of agricultural commodities, as defined in § 395.2.
The Agency recognizes that some enforcement personnel and other stakeholders have interpreted the agricultural commodity exception as inapplicable to any portion of a trip if the destination exceeds 150 air-miles from the source. Under that reading, the word “location” in § 395.1(k)(1) is interpreted as reflecting only the final destination of the load. FMCSA considers the statutory language, as amended,
(1) Transportation of agricultural commodities and farm supplies.—Regulations prescribed by the Secretary under sections 31136 and 31502 regarding maximum driving and on-duty time for drivers used by motor carriers shall not apply during planting and harvest periods, as determined by each State, to—
(A) Drivers transporting agricultural commodities from the source of the agricultural commodities to a location within a 150-air-mile radius from the source; . . .
(1) Agricultural commodities from the source of the agricultural commodities to a location within a 150 air-mile radius from the source;
. . . 49 CFR 395.1(k)(1). The term “agricultural commodity” is defined in 49 CFR 395.2.
Several agricultural transporters have requested guidance on the extent to which grain elevators or livestock sale barns, for example, should be considered a “source” of agricultural commodities under § 395.1(k)(1). Historically, the nature of the commodities included in the definition led to an informal conclusion that the “source” was the location where the crops were grown or the animals raised. That concept does not adequately address the aggregation and interim storage of commodities. The identification of the source is more reasonably defined by factors that include more than a farm or ranch.
As long as the commodity retains its original form, a place where the commodity is aggregated and stored may be treated as a “source” from which the 150 air-mile radius is measured.
Many transporters have also asked how the agricultural commodity exception would apply if the driver were to pick up partial loads at two or more locations. Specifically, they asked whether a pick-up at a subsequent source has the effect of extending the 150 air-mile radius,
Commenters explained that drivers often must pick up agricultural commodities at several locations to fill their vehicle. This is the only reasonable approach to making a living hauling
CVSA applauded efforts to update Agency guidance. It believes greater clarity is needed regarding the loading of agricultural commodities at multiple sources. It states that the exception should begin with the first source, and that stopping after that initial source should not restart the exception. In its view, the exception and the 150 air-mile radius should be applied from the original source only.
FMCSA issues Regulatory Guidance, Questions 34, 35, 36, and 37 to 49 CFR 395.1 as follows:
For example, a sales barn where cattle are loaded may be treated as a “source,” in addition to the location at which they were raised, since cattle remain livestock. As another example, a place where heads of lettuce are stored may become a “source,” provided they retain their original form. An elevator where grain is collected and dried may be a new “source,” again assuming that the grain is not milled or similarly processed at the elevator.
In accordance with section 5203(a)(2)(A) and (a)(3) of the Fixing America's Surface Transportation (FAST) Act, Public Law 114-94, 129 Stat. 1312, 1535 (Dec. 4, 2015), this regulatory guidance will be posted on FMCSA's website,
Federal Motor Carrier Safety Administration (FMCSA), DOT.
Regulatory guidance.
On December 19, 2017, FMCSA proposed revisions to the regulatory guidance concerning driving a commercial motor vehicle (CMV) for personal use while off-duty, referred to as “personal conveyance.” Over 380 comments were received in response to the draft guidance. This document provides revised guidance and addresses issues raised by commenters. This guidance applies to all CMV drivers required to record their hours of service (HOS) who are permitted by their carrier to use the vehicle for personal use.
This guidance is applicable on June 7, 2018 and expires June 7, 2023.
For information concerning this notice contact Ms. LaTonya Mimms, Transportation Specialist, Enforcement Division, FMCSA. Ms. Mimms may be reached at 202-366-0991 and by email at
The Federal Motor Carrier Safety Regulations (FMCSRs) require drivers to document their HOS on records of duty status (RODS), identifying one of four duty status options: (1) On-duty not driving, (2) driving, (3) sleeper berth, and (4) off-duty (49 CFR 395.8). The use of personal conveyance is a tool used to account for the movement of a CMV while the driver is off-duty.
Motor carriers are responsible for ensuring that drivers are not operating while ill or fatigued. However, motor carriers, at their discretion, may authorize their drivers to use a CMV while off-duty for personal conveyance. When this occurs, drivers are required to document such use as off-duty on their RODS, irrespective of the method used to record the driver's HOS (
The minimum performance and design standards for ELDs in the Agency's final rule on “Implementation of Electronic Logging Devices and Hours of Service Supporting Documents” (ELD rule) (80 FR 78292, December 15, 2015) include the automatic recording of data related to the off-duty movement and location of the CMV. As part of the ELD rule, ELD manufacturers are required to include a special driving category for personal conveyance. This may be used by drivers at the motor carriers' discretion.
The previous guidance on personal conveyance (49 CFR 395.8, Question 26) was issued by the Federal Highway Administration (FHWA), FMCSA's predecessor agency, in a memorandum dated November 18, 1996, and later published in a compilation of guidance (62 FR 16370, 16426, April 4, 1997). The guidance reiterated the basic principle that a driver in off-duty status must be relieved from work and all responsibility for performing work. It highlighted the use of the CMV as a personal conveyance in traveling to and from the place of employment (
On December 19, 2017. FMCSA issued revised guidance and requested comments. (82 FR 60269) In changing the guidance, the Agency focused on the reason the driver is operating a CMV while off-duty, without regard to whether the CMV is laden.
This notice clarifies issues raised such as using personal conveyance to leave a shipper or receiver and travel to a safe location for rest, the fact that the use of personal conveyance does not impact on-duty time, and provides additional scenarios in the guidance as to when the use of personal conveyance is allowable, and, includes passenger carrier specific scenarios.
FMCSA received over 380 comments on the proposed guidance. Over 300 of the comments were from individuals, with approximately 240 representing drivers of property-carrying CMVs. The remaining comments came from companies, associations, safety organizations, and two States. Companies included Cowboy Up Transport, Boyle Transportation, Crete Carrier, C.H. Robinson, and Schneider National. The associations included the American Bus Association, the American Trucking Associations, the Owner Operator Independent Drivers Association, the Truckload Carriers Association, and Western States Trucking Association. The safety organizations included the Commercial Vehicle Safety Alliance, Advocates for Highway and Auto Safety (AHAS), the Truck Safety Coalition and Road Safe America.
The majority of commenters supported expanding the definition to include laden vehicles. However, the Truck Safety Coalition and Road Safe America opposed this change, expressing concern that FMCSA was proposing to replace an objective standard with a subjective standard and that it would be difficult for law enforcement to assess a driver's intent to determine if the CMV is being used for personal conveyance. In addition, the Truck Safety Coalition and Road Safe America noted studies conducted by the FMCSA, National Institute of Occupational Safety and Health, Federal Highway Administration and National Highway Traffic Safety Administration, relating to the incidence of fatigue reported by long haul truck drivers and impact of pressures from the shipping community on fatigue.
AHAS also opposed this change for similar reasons and questioned the disparate impact on drivers of single unit trucks that FMCSA noted in the December 2017 notice.
Also, several motor carriers reiterated that the decision to allow the use of personal conveyance should remain with the company.
The purpose of the guidance is to provide additional clarity on the use of personal conveyance as a type of off-duty status. The guidance provides additional details to determine if a movement of the CMV is an appropriate off-duty use. The new guidance will improve uniformity for the industry and the enforcement communities. The clarity provided in this notice will lead to greater uniformity in the enforcement of the HOS rules.
In response to concerns that this guidance will somehow increase fatigue, FMCSA notes that there are no changes to the HOS rules in this document. In fact, because the current requirement to record HOS using ELDs makes the time spent driving a CMV as personal conveyance transparent to the motor carrier and enforcement, the Agency believes that consistency and uniformity in the application of the guidance by both the industry and enforcement will be increased. FMCSA recognizes that much of the pressure on drivers referenced in the comments results from delays during the loading or unloading process causing a driver to run out of hours. This guidance will have a positive impact on the concerns expressed by the Truck Safety Coalition, Road Safe America, and AHAS by giving drivers the flexibility to locate and obtain adequate rest as this would be off-duty time in personal conveyance status. In addition, as described above, this guidance, used in conjunction with the ELD rule will lead to greater uniformity in enforcement.
According to the FMCSA's records in the Motor Carrier Management Information System, there are approximately 2.3 million straight trucks that operate in interstate commerce. Under the previous guidance, the drivers of many straight trucks were not permitted to operate in an off-duty status for personal conveyance because they were laden. The revised guidance allows these vehicles, under the circumstances described in the guidance to be driven as a personal conveyance.
Other recurring issues or questions raised are discussed individually below.
Some commenters provided suggestions or requests that are outside of the scope of guidance. Those included modifying the HOS regulations so that there is a definition of personal conveyance consistent with the Canadian HOS regulation and establishing mileage or time limits for the use of personal conveyance.
In addition, some motor carriers and drivers questioned who would be liable in a crash when the driver is operating in the personal conveyance mode. FMCSA notes that this issue is outside of its authority and would be determined based on the contract or agreement between the motor carrier or owner of the commercial motor vehicle and the liability insurance provider as well as principles of State tort law.
Numerous commenters asked for clarification on how the use of personal conveyance impacts on-duty hours.
Personal conveyance is an off-duty status. Therefore, there are no impacts to the 11- or 14-hour limitations for truck drivers, the 10- or 15-hour limitations for bus drivers, the 60/70-hour limitations, the 34-hour restart provisions, or any other on-duty status.
Crete Carrier, Vilma Kuprescenko, Desiree Wood, Paul Tyler and many others suggested that a driver should be allowed to identify movement from a receiver or shipper, after exhausting his or her HOS, as personal conveyance, if that movement is to allow the driver to arrive at a safe location to obtain the required rest. Crete Carrier believes that not allowing the driver to identify such a movement as personal conveyance would be contrary to the coercion rule (49 CFR 390.6), as the shipper is forcing a driver to leave the premises even after exhausting his or her hours of service limits. Schneider National also asked for clarification on this issue.
The movement from a shipper or receiver to the nearest safe resting area may be identified as personal conveyance, regardless of whether the driver exhausted his or her HOS, as long as the CMV is being moved solely to enable the driver to obtain the required rest at a safe location. The Agency recognizes that the driver may not be aware of the direction of the next dispatch and that in some instances the nearest safe resting location may be in the direction of that dispatch. If the driver proceeds to the nearest reasonable and safe location and takes the required rest, this would qualify as personal conveyance. FMCSA recommends that the driver annotate on the log if he/she cannot park at the nearest location and must proceed to another location.
FMCSA also notes that the Coercion Rule is intended to protect drivers from motor carriers, shippers, receivers, or transportation intermediaries who threaten to withhold work from, take employment action against, or punish a driver for refusing to operate in violation the FMCSRs, Hazardous Materials Regulations, and the Federal Motor Carrier Commercial Regulations. Crete Carrier's reference to the coercion rule in the context of having to leave a shipper's/receiver's property is not accurate, provided that the shipper or receiver does not threaten to retaliate or take adverse action against the driver in violation of the rule.
Jeff Muzik asked about the impacts to the 10-hour break if a safety official requires the driver to move the CMV.
If a Federal, State or local law enforcement official requires a driver to relocate the CMV during the 10-hour break period for truck drivers or the 8-hour break period for bus drivers, personal conveyance may be used to document the movement. Again, as this is off-duty time, this does not require a restart of the rest period. However, the CMV must be moved no farther than the nearest reasonable and safe area to complete the rest period.
Schneider National noted that the draft scenarios in section (a) of the guidance to Question 26 implied that the driver must return to the last on-duty location but that other scenarios in the same section indicate otherwise. Allen England and Billy Barnes Enterprises expressed disagreement with any requirement to return to the last on-duty location.
The driver is not required to return to the previous on-duty location. A driver may resume on-duty status immediately after an off-duty status regardless of the location of the CMV.
Danny Schnautz, Brian Ausloos, and Doug Pope questioned FMCSA's description of “enhancing operational readiness.” Other carriers also provided examples of movements that they believed are personal conveyance but enhance operational readiness.
Enhancing operational readiness includes on-duty movement of a CMV that provides a commercial benefit to the motor carrier. For example, if the movement places the load closer to the destination, it may not be considered personal conveyance, except under circumstances outlined specifically in the examples provided in the guidance. Additionally, if a driver who is under dispatch stops at a location such as his/her home, because the driver's home is closer to the next destination or pick up location, then this would not be personal conveyance.
The American Bus Association (ABA) stated that the proposed guidance did not mention motorcoaches. ABA and others requested examples that specifically reference motorcoach operations. The United Motorcoach Association provided examples of personal conveyance, including use of a motorcoach to reach restaurants or pursue personal activities after dropping off passengers at a hotel or when a driver is using a motorcoach to transport drivers who are off-duty to pursue personal activities.
In addition, Michael Letlow requested confirmation that motorcoaches with luggage only are not considered laden.
Examples have been added to the final guidance that make clear that drivers of passenger-carrying operations may also use their vehicles for personal conveyance in appropriate circumstances. In addition, FMCSA reminds commenters that this guidance now applies regardless of whether the vehicle is laden. However, the requirement for the driver to be off-duty still exists. Therefore, if a driver is taking luggage to a hotel and is on-duty, personal conveyance would not apply. However, if the driver is off-duty and using a motorcoach with luggage on board to get lunch, personal conveyance would be appropriate.
FMCSA replaces Question 26 as noted below. In accordance with the requirement in Section 5203(a)(2)(A) of the Fixing America's Surface Transportation (FAST) Act, Public Law 114-94, 129 Stat. 1312, 1535, Dec. 4, 2015, the guidance above will be posted on FMCSA's website,
FMCSA reminds motor carriers and drivers that additional information about ELDs is available at
FMCSA updates the guidance for § 395.8 Driver's Record of Duty Status to read as follows:
(a) Examples of appropriate uses of a CMV while off-duty for personal conveyance include, but are not limited to:
1. Time spent traveling from a driver's en route lodging (such as a motel or truck stop) to restaurants and entertainment facilities.
2. Commuting between the driver's terminal and his or her residence, between trailer-drop lots and the driver's residence, and between work sites and his or her residence. In these scenarios, the commuting distance combined with the release from work and start to work times must allow the driver enough time to obtain the required restorative rest as to ensure the driver is not fatigued.
3. Time spent traveling to a nearby, reasonable, safe location to obtain required rest after loading or unloading. The time driving under personal conveyance must allow the driver adequate time to obtain the required rest in accordance with minimum off-duty periods under 49 CFR 395.3(a)(1) (property-carrying vehicles) or 395.5(a) (passenger-carrying vehicles) before returning to on-duty driving, and the resting location must be the first such location reasonably available.
4. Moving a CMV at the request of a safety official during the driver's off-duty time
5. Time spent traveling in a motorcoach without passengers to en route lodging (such as motel or truck stop), or to restaurants and entertainment facilities and back to the lodging. In this scenario, the driver of the motorcoach can claim personal conveyance provided the driver is off-duty. Other off-duty drivers may be on board the vehicle, and are not considered passengers.
6. Time spent transporting personal property while off-duty.
7. Authorized use of a CMV to travel home after working at an offsite location.
(b) Examples of uses of a CMV that would not qualify as personal conveyance include, but are not limited to, the following:
1. The movement of a CMV in order to enhance the operational readiness of a motor carrier. For example, bypassing available resting locations in order to get closer to the next loading or unloading point or other scheduled motor carrier destination.
2. After delivering a towed unit, and the towing unit no longer meets the definition of a CMV, the driver returns to the point of origin under the direction of the motor carrier to pick up another towed unit.
3. Continuation of a CMV trip in interstate commerce in order to fulfill a business purpose, including bobtailing or operating with an empty trailer in order to retrieve another load or repositioning a CMV (tractor or trailer) at the direction of the motor carrier.
4. Time spent driving a passenger-carrying CMV while passenger(s) are on board. Off-duty drivers are not considered passengers when traveling to a common destination of their own choice within the scope of this guidance.
5. Time spent transporting a CMV to a facility to have vehicle maintenance performed.
6. After being placed out of service for exceeding the maximum periods permitted under part 395, time spent driving to a location to obtain required rest, unless so directed by an enforcement officer at the scene.
7. Time spent traveling to a motor carrier's terminal after loading or unloading from a shipper or a receiver.
8. Time spent operating a motorcoach when luggage is stowed, the passengers have disembarked and the driver has been directed to deliver the luggage.
Federal Aviation Administration (FAA), DOT.
Notice of proposed rulemaking (NPRM).
We propose to supersede Airworthiness Directive (AD) 2018-11-05, which applies to certain Honda Aircraft Company (Honda) LLC Model HA-420 airplanes. AD 2018-11-05 requires incorporating a temporary revision into the airplane flight manual and replacing the faulty power brake valve (PBV) upon condition. Since AD 2018-11-05 was issued as an interim action in order to address the need for the immediate detection of a faulty PBV, we are issuing this proposed AD to address the long-term corrective action. This proposed AD would retain the actions required in AD 2018-11-05, would require replacing the faulty PBV with an improved design part at a specified time, and would prohibit future installations of the faulty PBVs on all Honda Model HA-420 airplanes. We are proposing this AD to address the unsafe condition on these products.
We must receive comments on this proposed AD by July 23, 2018.
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 Honda Aircraft Company LLC, 6430 Ballinger Road, Greensboro, North Carolina 27410; telephone (336) 662-0246; internet:
You may examine the AD docket on the internet at
Samuel Kovitch, Aerospace Engineer, Atlanta ACO Branch, FAA, 1701 Columbia Avenue, College Park, Georgia 30337; phone: (404) 474-5570; fax: (404) 474-5605; 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
We issued AD 2018-11-05, Amendment 39-19293 (83 FR 24016, May 24, 2018), (“AD 2018-11-05), for certain Honda Aircraft Company LLC (Honda) Model HA-420 airplanes. AD 2018-11-05 requires inserting a temporary revision into the airplane flight manual (AFM), which may be performed by the owner/operator (pilot) holding at least a private pilot certificate and must be entered into the airplane records showing compliance with the AD in accordance with 14 CFR 43.9 (a)(1)-(4) and 14 CFR 91.417(a)(2)(v). AD 2018-11-05 also requires a conditional replacement of the installed power brake valve (PBV), P/N HJ1-13243-101-005 or P/N HJ1-13243-101-007, with an improved PBV, P/N HJ1-13243-101-009, if any of the procedures listed in the AFM temporary revision reveals a leaking PBV. In addition, AD 2018-11-05 provides an optional terminating action for inserting the temporary revision into the AFM by replacing the installed P/N HJ1-13243-101-005 or P/N HJ1-13243-101-007 with the improved P/N HJ1-13243-101-009. AD 2018-11-05 resulted from reports of unannunciated asymmetric braking during ground operations and landing deceleration.
We issued AD 2018-11-05 to prevent failure of the PBV, which could cause degraded braking performance and reduced directional control during ground operations and landing deceleration.
Since AD 2018-11-05 was issued as an interim action in order to address the need for the immediate detection of a faulty PBV (the short-term action of inserting the temporary revision into the AFM), we are issuing this proposed AD to address the long-term corrective action (replacing the PBV).
We reviewed Honda Aircraft Company Temporary Revision TR 01.1, dated February 16, 2018, to the Honda Aircraft Company HA-420 Airplane Flight Manual and Service Bulletin SB-420-32-001, dated January 8, 2018, and
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 retain the requirements of AD 2018-11-05. This proposed AD would also require replacing the installed PBV, P/N HJ1-13243-101-005 or P/N HJ1-13243-101-007, with the improved design PBV, P/N HJ1-13243-101-009, at a specified time.
Honda Service Bulletin SB-420-32-001, dated January 8, 2018, and Revision B, dated April 16, 2018, specify submitting certain information to the manufacturer. This AD does not require that action.
We estimate that this proposed AD affects 72 airplanes of U.S. registry.
We estimate the following costs to comply with this proposed AD:
Replacing the PBV was provided as an on-condition cost and an optional terminating action in AD 2018-11-05. We have no way of determining how many owner/operators of the affected airplanes may have already done this proposed replacement. Therefore, we have included a total cost for all affected airplanes.
The difference in the Cost of Compliance between AD 2018-11-05 and this proposed AD is the proposed requirement to replace the power brake valve at a specified time.
Title 49 of the United States Code specifies the FAA's authority to issue rules on aviation safety. Subtitle I, Section 106, describes the authority of the FAA Administrator. Subtitle VII, Aviation Programs, describes in more detail the scope of the Agency's authority.
We are issuing this rulemaking under the authority described in Subtitle VII, Part A, Subpart III, section 44701, “General requirements.” Under that section, Congress charges the FAA with promoting safe flight of civil aircraft in air commerce by prescribing regulations for practices, methods, and procedures the Administrator finds necessary for safety in air commerce. This regulation is within the scope of that authority because it addresses an unsafe condition that is likely to exist or develop on products identified in this rulemaking action.
This AD is issued in accordance with authority delegated by the Executive Director, Aircraft Certification Service, as authorized by FAA Order 8000.51C. In accordance with that order, issuance of ADs is normally a function of the Compliance and Airworthiness Division, but during this transition period, the Executive Director has delegated the authority to issue ADs applicable to small airplanes, gliders, balloons, airships, domestic business jet transport airplanes, and associated appliances to the Director of the Policy and Innovation Division.
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 July 23, 2018.
This AD replaces AD 2018-11-05, Amendment 39-19293 (83 FR 24016, May 24, 2018).
This AD applies to Honda Aircraft Company LLC Model HA-420 airplanes, all serial numbers, that:
(1) Have power brake valve, part number (P/N) HJ1-13243-101-005 or HJ1-13243-101-007, installed; and
(2) are certificated in any category.
Joint Aircraft System Component (JASC)/Air Transport Association (ATA) of America Code 32, Landing Gear.
This AD was prompted by reports of unannunciated asymmetric braking during ground operations and landing deceleration. We are issuing this AD to detect failure of the power brake valve (PBV). The unsafe condition, if not addressed, could result in degraded braking performance and reduced directional control during ground operations and landing deceleration.
Comply with this AD within the compliance times specified, unless already done.
Before further flight after May 29, 2018 (the effective date retained from AD 2018-11-05) insert Honda Aircraft Company Temporary Revision TR 01.1, dated February 16, 2018, into the Honda Aircraft Company (Honda) HA-420 Airplane Flight Manual (AFM) (“the temporary revision”). The procedures listed in the temporary revision are required while operating with PBV P/N HJ1-13243-101-005 or P/N HJ1-13243-101-007 installed. This insertion and the steps therein may be performed by the owner/operator (pilot) holding at least a private pilot certificate and must be entered into the airplane records showing compliance with this AD in accordance with 14 CFR 43.9(a)(1)-(4) and 14 CFR 91.417(a)(2)(v). The record must be maintained as required by 14 CFR 91.417, 121.380, or 135.439.
Although Honda Service Bulletin SB-420-32-001, dated January 8, 2018, and Revision B, dated April 16, 2018, specify submitting certain information to the manufacturer, this AD does not require that action.
As of and at any time after May 29, 2018 (the effective date retained from AD 2018-11-05), if any of the procedures listed in the temporary revision referenced in paragraph (g) of this AD reveal a leaking PBV, before further flight, replace the installed PBV, P/N HJ1-13243-101-005 or P/N HJ1-13243-101-007, with the improved design PBV, P/N HJ1-13243-101-009. The replacement must be done using the Accomplishment Instructions in either Honda Service Bulletin SB-420-32-001, dated January 8, 2018, or Revision B, dated April 16, 2018. Before further flight after installing P/N HJ1-13243-101-009, remove the temporary revision from the Honda HA-420 AFM.
(1) Instead of inserting the temporary revision or at any time after inserting the temporary revision required by paragraph (g) of this AD and before the mandatory replacement required in paragraph (j) of this AD, you may replace the installed PBV, P/N HJ1-13243-101-005 or P/N HJ1-13243-101-007, with the improved design PBV, P/N HJ1-13243-101-009. The replacement must be done using the Accomplishment Instructions in either Honda Service Bulletin SB-420-32-001, dated January 8, 2018, or Revision B, dated April 16, 2018. Before further flight after installing P/N HJ1-13243-101-009, remove the temporary revision from the Honda HA-420 AFM.
(2) The on-condition replacement required by paragraph (h) of this AD is still required before further flight.
Within the next 12 months after the effective date of this AD, replace the installed PBV, P/N HJ1-13243-101-005 or P/N HJ1-13243-101-007, with the improved design PBV, P/N HJ1-13243-101-009. The replacement must be done using the Accomplishment Instructions in either Honda Service Bulletin SB-420-32-001, dated January 8, 2018, or Revision B, dated April 16, 2018. Before further flight after installing P/N HJ1-13243-101-009, remove the temporary revision from the Honda HA-420 AFM.
Special flight permits for the AFM Limitations portion of this AD are prohibited. Special flight permits for the PBV replacement required in this AD are permitted with the following limitations: One ferry flight, including fuel stops, to service center with Honda Aircraft Company Temporary Revision TR 01.1, dated February 16, 2018, incorporated into the Honda HA-420 AFM.
(1) The Manager, Atlanta ACO Branch, FAA, has the authority to approve AMOCs for this AD, if requested using the procedures found in 14 CFR 39.19. In accordance with 14 CFR 39.19, send your request to your principal inspector or local Flight Standards District Office, as appropriate. If sending information directly to the manager of the certification office, send it to the attention of the person identified in paragraph (n) of this AD.
(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) For service information that contains steps that are labeled as Required for Compliance (RC), the provisions of paragraphs (h) through (j) 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 Samuel Kovitch, Aerospace Engineer, Atlanta ACO Branch, FAA, 1701 Columbia Avenue, College Park, Georgia 30337; phone: (404) 474-5570; fax: (404) 474-5605; email:
(2) For service information identified in this AD, contact Honda Aircraft Company LLC, 6430 Ballinger Road, Greensboro, North Carolina 27410; telephone (336) 662-0246; internet:
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 707 series airplanes and Model 720 and 720B series airplanes. This proposed AD was prompted by a report indicating that a fracture of the midspar fitting resulted in the separation of the inboard strut and engine from the airplane, and a determination that existing inspections are not sufficient for timely detection of cracking. This proposed AD would require repetitive inspections of certain nacelle strut spar and overwing fittings, and diagonal braces and associated fittings; replacement of the diagonal brace assembly on certain airplanes; and applicable related investigative and corrective actions. We are proposing
We must receive comments on this proposed AD by July 23, 2018.
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: Contractual & Data Services (C&DS), 2600 Westminster Blvd., MC 110-SK57, Seal Beach, CA 90740-5600; telephone 562-797-1717; internet
You may examine the AD docket on the internet at
Jeffrey Chang, Aerospace Engineer, Propulsion Section, FAA, Los Angeles ACO Branch, 3960 Paramount Boulevard, Lakewood, CA 90712-4137; phone: 562-627-5263; fax: 562-627-5210; 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 reports of cracking of the midspar fittings and of the engine and nacelle strut separating from the airplane. We issued AD 2012-16-12, Amendment 39-16159 (77 FR 49708, August 17, 2012) to require inspection of the inboard and outboard strut midspar fittings and AD 2015-11-04, Amendment 39-18167 (80 FR 30605, May 29, 2015) to require replacement of all engine strut midspar fittings and to initiate a life limit program. Since that time, we have determined that inspections of other strut fittings are needed for timely detection of cracking. Cracks have been reported in the diagonal brace end fittings, forward mating fittings, aft mating fittings, overwing support fittings, and the upper surface and the aft lug(s) of the front spar fittings on the nacelle struts, numbers 1, 2, 3 and 4. This cracking is attributed to fatigue in the end fittings and stress corrosion or fatigue in the mating fittings. This condition, if not addressed, could result in cracks that grow beyond a critical length, allowing strut fittings to fail and reducing the structural integrity of the nacelle. This, in combination with damage to adjacent attachment structure, could result in the loss of an engine from the airplane.
We reviewed the following service information.
• Boeing 707 Alert Service Bulletin A3364, Revision 4, dated February 21, 2017. The service information describes procedures for repetitive detailed inspections of the diagonal brace tube for any crack; repetitive detailed inspections and high frequency eddy current (HFEC) inspections of the nacelle strut diagonal brace end fittings, forward mating fitting, and aft mating fitting for any crack; an alternative dye penetrant inspection of vertical webs on aft mating fitting for any crack; an HFEC inspection of the diagonal brace tube for any crack; and corrective actions.
• Boeing 707 Alert Service Bulletin A3365, Revision 3, dated March 9, 2017. The service information describes procedures for repetitive detailed, HFEC, and ultrasonic inspections of the overwing support fittings for any crack at the bolt hole forward of the wing front spar and at the holes for the four fasteners attaching the fitting to the spar, and related investigative and corrective actions.
• Boeing 707 Alert Service Bulletin A3514, Revision 1, dated November 9, 2016. The service information describes procedures for repetitive detailed and surface HFEC inspections of the front spar fittings at nacelle struts numbers 1, 2, 3, and 4 for cracks, and replacement of cracked front spar fittings.
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 these same type designs.
This proposed AD would require accomplishing the actions specified in the service information described previously, except as discussed under “Differences Between this Proposed AD and the Service Information.” For information on the procedures and compliance times, see this service information at
The phrase “related investigative actions” is used in this proposed AD. Related investigative actions are follow-on actions that (1) are related to the primary action, and (2) further investigate the nature of any condition found. Related investigative actions in an AD could include, for example, inspections.
The phrase “corrective actions” is used in this proposed AD. Corrective actions correct or address any condition found. Corrective actions in an AD could include, for example, repairs.
Boeing 707 Alert Service Bulletin A3364, Revision 4, dated February 21, 2017; Boeing 707 Alert Service Bulletin A3365, Revision 3, dated March 9, 2017; and Boeing 707 Alert Service Bulletin A3514, Revision 1, dated November 9, 2016; specify to contact the manufacturer for certain instructions, but this proposed AD would require using repair methods, modification deviations, replacement deviations, and alteration deviations in one of the following ways:
• In accordance with a method that we approve; or
• Using data that meet the certification basis of the airplane, and that have been approved by the Boeing Commercial Airplanes Organization Designation Authorization (ODA) whom we have authorized to make those findings.
We estimate that this proposed AD affects 65 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 cost estimates for the on-condition actions specified in this proposed AD.
We estimate that any necessary proposed replacement of affected fittings would take about 96 work-hours for a cost of $8,160 per fitting. We have received no definitive data on the parts costs of the affected fittings. We have no way of determining the number of aircraft that might need this replacement.
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 proposed AD is issued in accordance with authority delegated by the Executive Director, Aircraft Certification Service, as authorized by FAA Order 8000.51C. In accordance with that order, issuance of ADs is normally a function of the Compliance and Airworthiness Division, but during this transition period, the Executive Director has delegated the authority to issue ADs applicable to transport category airplanes and associated appliances to the Director of the System Oversight Division.
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 July 23, 2018.
This AD affects AD 82-24-03, Amendment 39-4496 (47 FR 51099, November 12, 1982) (“AD 82-24-03”) and AD 2005-08-15, Amendment 39-14067 (70 FR 21136, April 25, 2005) (“AD 2005-08-15”).
This AD applies to all The Boeing Company Model 707-100 Long Body, -200, -100B Long Body, and -100B Short Body series airplanes; Model 707-300, -300B, -300C, and -400 series airplanes; and Model 720 and 720B series airplanes; certificated in any category.
Air Transport Association (ATA) of America Code 54, Nacelles/pylons.
This AD was prompted by a report indicating that a fracture of the midspar fitting resulted in the separation of the inboard strut and engine from the airplane, and a determination that existing inspections for other nacelle strut fittings are not sufficient for timely detection of cracking. We are issuing this AD to address cracks, which if not detected and corrected, could grow beyond a critical length, allowing the strut fitting to fail and reducing the structural integrity of the nacelle. This, in combination with damage to adjacent attachment structure, could result in the loss of an engine from the airplane.
Comply with this AD within the compliance times specified, unless already done.
Prior to the accumulation of 3,500 total flight hours; within 700 flight hours after the most recent inspection specified in Boeing 707 Alert Service Bulletin A3514, dated July 29, 2004, was done; or within three months after the effective date of this AD; whichever occurs later: Do a detailed inspection for cracking of the front spar fittings at nacelle struts numbers 1, 2, 3, and 4, in accordance with the Accomplishment Instructions of Boeing 707 Alert Service Bulletin A3514, Revision 1, dated November 9, 2016. If any cracking is found, before further flight, replace the affected fitting, in accordance with the Accomplishment Instructions of Boeing 707 Alert Service Bulletin A3514, Revision 1, dated November 9, 2016. Repeat the inspections thereafter at intervals not to exceed 700 flight hours.
Within 1,500 flight cycles or 48 months after the most recent detailed inspection required by paragraph (g) of this AD was done, whichever occurs first, do a surface HFEC inspection for cracking of the aft lugs on the front spar fittings at nacelle struts numbers 1, 2, 3, and 4, and do all applicable corrective actions, in accordance with the Accomplishment Instructions of Boeing 707 Alert Service Bulletin A3514, Revision 1, dated November 9, 2016, except as required by paragraph (l)(4) of this AD. Do all applicable corrective actions before further flight. Repeat the inspection thereafter at intervals not to exceed 1,500 flight cycles or 48 months, whichever occurs first.
At the times specified in paragraph 1.E., “Compliance,” of Boeing 707 Alert Service Bulletin A3365, Revision 3, dated March 9, 2017, except as required by paragraph (l)(1) of this AD: Do the inspections specified in paragraphs (i)(1) through (i)(3) of this AD and do all applicable related investigative and corrective actions, in accordance with the Accomplishment Instructions of Boeing 707 Alert Service Bulletin A3365, Revision 3, dated March 9, 2017, except as required by paragraph (l)(3) of this AD. Do all applicable related investigative and corrective actions before further flight. Repeat the inspections thereafter at the applicable time specified in paragraph 1.E., “Compliance,” of Boeing 707 Alert Service Bulletin A3365, Revision 3, dated March 9, 2017.
(1) Do a detailed inspection for any crack at all five holes in the overwing support fitting, and at the flange radii.
(2) Do the inspection specified in paragraph (i)(2)(i) or (i)(2)(ii) of this AD.
(i) Do a surface HFEC inspection for any crack in the overwing support fitting around the hole immediately forward of the spar chord, with the bolt in place, and at the flange radii.
(ii) Do an open hole HFEC inspection for any crack in the overwing support fitting at the hole immediately forward of the spar chord.
(3) Do the inspection specified in paragraph (i)(3)(i) or (i)(3)(ii) of this AD.
(i) Do an ultrasonic inspection for any crack in the overwing support fitting around the four holes common to the fitting and the spar chord, with the bolts in place.
(ii) Do a surface HFEC inspection for any crack in the overwing support fitting around the four holes common to the fitting and the spar chord, with the bolts in place.
For airplanes with nacelle strut diagonal braces and associated fittings which have accumulated 7,500 flight cycles or more: At the applicable times specified in paragraph 1.E., “Compliance” of Boeing 707 Alert Service Bulletin A3364, Revision 4, dated February 21, 2017, except as required by paragraph (l)(2) of this AD, do the inspections specified in paragraphs (j)(1) through (j)(3) of this AD. Repeat the inspections thereafter at the applicable intervals specified in tables 1, 2, 3, and 4 of paragraph 1.E., “Compliance,” of Boeing 707 Alert Service Bulletin A3364, Revision 4, dated February 21, 2017. If any crack is found during any inspection required by this paragraph, before further flight, do all applicable corrective actions, in accordance with the Accomplishment Instructions of Boeing 707 Alert Service Bulletin A3364, Revision 4, dated February 21, 2017, except as required by paragraph (l)(3) of this AD.
(1) Do a detailed inspection of the nacelle strut diagonal brace end fittings, diagonal brace tube, forward mating fitting, and aft mating fitting for any crack.
(2) Do HFEC inspections of the nacelle strut diagonal brace end fittings, forward mating fitting, and aft mating fitting for any crack. As an alternative for the aft mating fitting, do a dye penetrant inspection of vertical webs on aft mating fitting for any crack.
(3) Do an HFEC inspection of the diagonal brace tube for any crack.
For Group 3, 4, and 6 airplanes as identified in Boeing 707 Alert Service Bulletin A3364, Revision 4, dated February 21, 2017, on which the outboard diagonal brace end fitting (forward or aft) attach holes have been oversized as specified in Boeing 707 Alert Service Bulletin A3364, Revision 4, dated February 21, 2017: Within 1,000 flight cycles after the effective date of this AD, replace the diagonal brace assembly, in accordance with Figure 3 of Boeing 707 Alert Service Bulletin A3364, Revision 4, dated February 21, 2017.
(1) For purposes of determining compliance with the requirements of this AD: Where Boeing 707 Alert Service Bulletin A3365, Revision 3, dated March 9, 2017, uses the phrase “the Revision 3 date of this service bulletin,” this AD requires using “the effective date of this AD.”
(2) For purposes of determining compliance with the requirements of this AD: Where Boeing 707 Alert Service Bulletin A3364, Revision 4, dated February 21, 2017, uses the phrase “the Revision 4 date of this service bulletin,” this AD requires using “the effective date of this AD.”
(3) Where Boeing 707 Alert Service Bulletin A3364, Revision 4, dated February 21, 2017; and Boeing 707 Alert Service Bulletin A3365, Revision 3, dated March 9, 2017; specify contacting Boeing: This AD requires repair using a method approved in accordance with the procedures specified in paragraph (o) of this AD.
(4) Where Boeing 707 Alert Service Bulletin A3514, Revision 1, dated November 9, 2016, specifies contacting Boeing: This AD requires replacement using a method approved in accordance with the procedures specified in paragraph (o) of this AD.
(1) Accomplishing the initial inspections required by paragraph (j) of this AD terminates all requirements of AD 82-24-03.
(2) Accomplishing the initial inspections required by paragraph (g) of this AD, terminates all requirements of AD 2005-08-15.
As of the effective date of this AD, no person may install, on any airplane, a front spar fitting having a part number other than the part numbers specified in paragraph 2.C.2. of Boeing 707 Alert Service Bulletin A3514, Revision 1, dated November 9, 2016.
(1) The Manager, Los Angeles ACO Branch, FAA, has the authority to approve AMOCs for this AD, if requested using the procedures found in 14 CFR 39.19. In accordance with 14 CFR 39.19, send your request to your principal inspector or local Flight Standards District Office, as appropriate. If sending information directly to the manager of the certification office, send it to the attention of the person(s) identified in paragraph (p)(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
(3) An AMOC that provides an acceptable level of safety may be used for any repair, modification, replacement, 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 Branch, to make those findings. To be approved, the repair method, modification deviation, replacement deviation, or alteration deviation must meet the certification basis of the airplane, and the approval must specifically refer to this AD.
(1) For more information about this AD, contact Jeffrey Chang, Aerospace Engineer, Propulsion Section, FAA, Los Angeles ACO Branch, 3960 Paramount Boulevard, Lakewood, CA 90712-4137; phone: 562-627-5263; fax: 562-627-5210; email:
(2) For service information identified in this AD, contact Boeing Commercial Airplanes, Attention: Contractual & Data Services (C&DS), 2600 Westminster Blvd., MC 110-SK57, Seal Beach, CA 90740-5600; telephone 562-797-1717; internet
Federal Aviation Administration (FAA), DOT.
Notice of proposed rulemaking (NPRM).
We propose to adopt a new airworthiness directive (AD) for Airbus Helicopters Deutschland GmbH (Airbus Helicopters) Model MBB-BK 117 C-2 and MBB-BK 117 D-2 helicopters. This proposed AD would require altering and re-identifying the overhead panel shock mount assembly (shock mount). This proposed AD is prompted by the manufacturer's stress recalculations. The actions of this proposed AD are intended to correct an unsafe condition on these products.
We must receive comments on this proposed AD by August 6, 2018.
You may send comments by any of the following methods:
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•
•
•
You may examine the AD docket on the internet at
For service information identified in this proposed rule, contact Airbus Helicopters, 2701 N. Forum Drive, Grand Prairie, TX 75052; telephone (972) 641-0000 or (800) 232-0323; fax (972) 641-3775; or at
Matt Fuller, Senior Aviation Safety Engineer, Safety Management Section, Rotorcraft Standards Branch, FAA, 10101 Hillwood Pkwy., Fort Worth, TX 76177; telephone (817) 222-5110; email
We invite you to participate in this rulemaking by submitting written comments, data, or views. We also invite comments relating to the economic, environmental, energy, or federalism impacts that might result from adopting the proposals in this document. The most helpful comments reference a specific portion of the proposal, explain the reason for any recommended change, and include supporting data. To ensure the docket does not contain duplicate comments, commenters should send only one copy of written comments, or if comments are filed electronically, commenters should submit only one time.
We will file in the docket all comments that we receive, as well as a report summarizing each substantive public contact with FAA personnel concerning this proposed rulemaking. Before acting on this proposal, we will consider all comments we receive on or before the closing date for comments. We will consider comments filed after the comment period has closed if it is possible to do so without incurring expense or delay. We may change this proposal in light of the comments we receive.
EASA, which is the Technical Agent for the Member States of the European Union, has issued EASA AD No. 2017-0026, dated February 14, 2017, to correct an unsafe condition for Airbus Helicopters Model MBB-BK 117 C-2, MBB-BK117 C-2e, MBB-BK 117 D-2, and MBB-BK117 D-2m helicopters. EASA advises that a recent stress calculation identified that the shock mount may not withstand certification crash loads. EASA states that this condition, if not corrected, could lead to the overhead panel disconnecting during an emergency landing and injuring occupants. Accordingly, the EASA AD requires modifying and re-identifying the shock mounts.
These helicopters have been approved by the aviation authority of Germany and are approved for operation in the United States. Pursuant to our bilateral agreement with Germany, EASA, its technical representative, has notified us of the unsafe condition described in its AD. We are proposing this AD because we evaluated all known relevant information and determined that an unsafe condition is likely to exist or develop on other products of the same type design.
We reviewed Airbus Helicopters Alert Service Bulletin (ASB) MBB-BK117 C-2-24A-015 for Model MBB-BK117 C-2 helicopters and ASB MBB-BK117 D-2-24A-004 for Model MBB-BK117 D‐2 helicopters, both Revision 0 and dated September 14, 2016. This service information contains procedures for altering the shock mounts by installing retaining plates and re-identifying the shock mounts by changing the last three digits of the part number (P/N) to -966.
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 proposed AD would require installing a retaining plate on the shock mount and re-identifying the shock mount by changing the last three digits of the P/N to -966.
This proposed AD would also prohibit installing shock mount P/N B246M2035102 and P/N B246M2036101 on any helicopter.
The EASA AD applies to Model MBB-BK117 D-2m helicopters, whereas this proposed AD would not since the Model MBB-BK117 D-2m is not FAA type-certificated. This proposed AD would also not include the Model MBB-BK117 C-2(e) in the applicability section because it is a marketing designation and not an FAA type-certificated model. However, this proposed AD would apply to those helicopters, as they are Model MBB-BK117 C-2 helicopters. The EASA AD specifies particular helicopter serial numbers (S/Ns) that may not be required to complete some of the requirements of the AD since the specified S/Ns were manufactured with shock mounts not affected by the unsafe condition. This proposed AD does not specify particular S/Ns.
We estimate that this proposed AD would affect 144 helicopters of U.S. Registry. We estimate that operators may incur the following costs in order to comply with this AD. Labor costs are estimated at $85 per work-hour.
Installing retaining plates and re-identifying the four shock mounts would take about 3 work-hours and parts would cost about $184 for a total estimated cost of $439 per helicopter and $63,216 for the U.S. fleet.
According to Airbus Helicopter's service information, some of the costs of this proposed AD may be covered under warranty, thereby reducing the cost impact on affected individuals. We do not control warranty coverage by Airbus. Accordingly, we have included all costs in our cost estimate.
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, 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 to the extent that it justifies making a regulatory distinction; 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.
We prepared an economic evaluation of the estimated costs to comply with this proposed AD and placed it in the AD docket.
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.
This AD applies to Model MBB-BK 117 C-2 and Model MBB-BK 117 D-2 helicopters, certificated in any category, with an overhead panel shock mount assembly part number (P/N) B246M2035102 or P/N B246M2036101 installed.
Note 1 to paragraph (a) of this AD: Helicopters with an MBB-BK117 C-2e designation are Model MBB-BK117 C-2 helicopters.
This AD defines the unsafe condition as failure of an overhead panel shock mount assembly (shock mount). This condition could result in detachment of the overhead panel and injury to occupants during an emergency landing.
We must receive comments by August 6, 2018.
You are responsible for performing each action required by this AD within the specified compliance time unless it has already been accomplished prior to that time.
(1) Within 300 hours time-in-service:
(i) Install a retaining plate on each shock mount by following the Accomplishment Instructions, paragraphs 3.B.2.1. through 3.B.2.4, of Airbus Helicopters Alert Service Bulletin (ASB) MBB-BK117 C-2-24A-015, Revision 0, dated September 14, 2016 (ASB MBB-BK117 C-2-24A-015), or ASB MBB-BK117 D-2-24A-004, Revision 0, dated September 14, 2016 (ASB MBB-BK117 D-2-24A-004), as applicable to your model helicopter.
(ii) Re-identify shock mount P/N B246M2035102 as P/N B246M2035966 and shock mount P/N B246M2036101 as P/N B246M2036966 using permanent ink. When the ink is dry, apply varnish over the P/N.
(iii) Re-install each shock mount.
(2) After the effective date of this AD, do not install a shock mount P/N B246M2035102 or P/N B246M2036101 on any helicopter.
(1) The Manager, Safety Management Section, Rotorcraft Standards Branch, FAA, may approve AMOCs for this AD. Send your proposal to: Matt Fuller, Senior Aviation Safety Engineer, Safety Management Section, Rotorcraft Standards Branch, FAA, 10101 Hillwood Pkwy., Fort Worth, TX 76177; telephone (817) 222-5110; email
(2) For operations conducted under a 14 CFR part 119 operating certificate or under 14 CFR part 91, subpart K, we suggest that you notify your principal inspector, or lacking a principal inspector, the manager of the local flight standards district office or certificate holding district office before operating any aircraft complying with this AD through an AMOC.
The subject of this AD is addressed in European Aviation Safety Agency (EASA) AD No. 2017-0026, dated February 14, 2017. You may view the EASA AD on the internet at
Joint Aircraft Service Component (JASC) Code: 2400, Electrical Power System.
Federal Aviation Administration (FAA), DOT.
Notice of proposed rulemaking (NPRM).
We propose to adopt a new airworthiness directive (AD) for all 328 Support Services GmbH Model 328-100 and -300 airplanes. This proposed AD was prompted by reports indicating corrosion on the horizontal stabilizer bearing supports at the contact surface to the horizontal stabilizer rear spar. This proposed AD would require inspections for corrosion and any other damage (
We must receive comments on this proposed AD by July 23, 2018.
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 328 Support Services GmbH, Global Support Center, P.O. Box 1252, D-82231 Wessling, Federal Republic of Germany; telephone +49 8153 88111 6666; fax +49 8153 88111 6565; email
You may examine the AD docket on the internet at
Todd Thompson, Aerospace Engineer, International Section, Transport Standards Branch, FAA, 2200 South 216th St., Des Moines, WA 98198; telephone and fax 206-231-3228.
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
The European Aviation Safety Agency (EASA), which is the Technical Agent for the Member States of the European Union, has issued EASA Airworthiness Directive 2017-0239, dated November 30, 2017 (referred to after this as the Mandatory Continuing Airworthiness Information, or “the MCAI”), to correct an unsafe condition for all 328 Support Services GmbH Model 328-100 and -300 airplanes. The MCAI states:
Occurrences were reported on horizontal stabilizer bearing supports being found corroded at the contact surface to the horizontal stabilizer rear spar. The corroded area was at the lower flange position, which is connected to the stabilizer rear spar and not visible without detachment of the fitting. Investigation determined that the corrosion is triggered by galvanic effect, due to a direct contact between the horizontal stabilizer rear spar, made from CFRP (carbon fibre reinforced plastic), and the aluminium rear attachment fitting.
This condition, if not detected and corrected, could lead to failure of the fitting and loss of one load path of the horizontal stabilizer attachment, possibly resulting in reduced control of the aeroplane.
To address this potential unsafe condition, 328 Support Services GmbH (328 SSG) issued Service Bulletin (SB) SB-328-55-557 and SB-328J-55-324 to provide instructions for inspection of the affected area, replacement of the parts, and modification to improve corrosion behaviour by incorporating of glass fibre layer.
For the reasons described above, this [EASA] AD requires a one-time inspection [detailed visual inspection and an eddy current inspection for chafing and corrosion] of the horizontal stabilizer rear bearing supports, and, depending on findings, accomplishment of applicable corrective action(s) [replacement of the affected horizontal stabilizer rear bearing supports]. This [EASA] AD also requires a modification of the horizontal stabilizer rear spar, irrespective of findings.
You may examine the MCAI in the AD docket on the internet at
328 Support Services GmbH has issued Service Bulletin SB-328-55-557, Revision 1, dated February 1, 2018; and Service Bulletin SB-328J-55-324, Revision 1, dated February 1, 2018. This service information describes a detailed visual inspection and an eddy current inspection for corrosion and any other damage (
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 the same type design.
We estimate that this proposed AD affects 27 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 replacement 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 replacement:
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 proposed AD is issued in accordance with authority delegated by the Executive Director, Aircraft Certification Service, as authorized by FAA Order 8000.51C. In accordance with that order, issuance of ADs is normally a function of the Compliance and Airworthiness Division, but during this transition period, the Executive Director has delegated the authority to issue ADs applicable to transport category airplanes to the Director of the System Oversight Division.
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:
1. The authority citation for part 39 continues to read as follows:
49 U.S.C. 106(g), 40113, 44701.
2. The FAA amends § 39.13 by adding the following new airworthiness directive (AD):
We must receive comments by July 23, 2018.
None.
This AD applies to all 328 Support Services GmbH (Type Certificate previously held by AvCraft Aerospace GmbH; Fairchild Dornier GmbH; Dornier Luftfahrt GmbH) Model 328-100 and -300 airplanes, certificated in any category.
Air Transport Association (ATA) of America Code 55, Stabilizers.
This AD was prompted by reports indicating corrosion on the horizontal stabilizer bearing supports at the contact surface to the horizontal stabilizer rear spar. We are issuing this AD to address corrosion on the horizontal stabilizer bearing supports and rear spar, which could lead to failure of the fitting and loss of one load path of the horizontal stabilizer attachment, and possibly result in reduced controllability of the airplane.
Comply with this AD within the compliance times specified, unless already done.
(1) At the applicable time specified in paragraph (g)(3)(i) or (g)(3)(ii) of this AD, do a detailed visual inspection and an eddy current inspection for corrosion and any other damage (
(2) At the applicable time specified in paragraph (g)(3)(i) or (g)(3)(ii) of this AD, modify the horizontal stabilizer rear spar in accordance with the Accomplishment Instructions of 328 Support Services GmbH Service Bulletin SB-328-55-557, Revision 1, dated February 1, 2018 (for Model 328-100 airplanes); or 328 Support Services GmbH Service Bulletin SB-328J-55-324, Revision 1, dated February 1, 2018 (for Model 328-300 airplanes); as applicable.
(3) Do the actions in paragraphs (g)(1) and (g)(2) at the applicable compliance time specified in paragraph (g)(3)(i) or (g)(3)(ii) of this AD.
(i) For Group 1 airplanes as identified in 328 Support Services GmbH Service Bulletin SB-328-55-557, Revision 1, dated February 1, 2018 (for Model 328-100 airplanes); or 328 Support Services GmbH Service Bulletin SB-328J-55-324, Revision 1, dated February 1, 2018 (for Model 328-300 airplanes); as applicable: Within 1,000 flight cycles or 8 months, whichever occurs first after the effective date of this AD.
(ii) For Group 2 airplanes as identified in 328 Support Services GmbH Service Bulletin SB-328-55-557, Revision 1, dated February 1, 2018 (for Model 328-100 airplanes); or 328 Support Services GmbH Service Bulletin SB-328J-55-324, Revision 1, dated February 1, 2018 (for Model 328-300 airplanes); as applicable: Within 5,000 flight hours or 30 months, whichever occurs first after the effective date of this AD.
If, during the inspections required by paragraph (g) of this AD, corrosion or any other damage (
As of the applicable time specified in paragraph (i)(1) or (i)(2) of this AD, no person may install a horizontal stabilizer rear bearing support, part number 001B551A1441000, on any airplane.
(1) For Group 1 airplanes as identified in 328 Support Services GmbH Service Bulletin SB-328-55-557, Revision 1, dated February 1, 2018 (for Model 328-100 airplanes); or 328 Support Services GmbH Service Bulletin SB-328J-55-324, Revision 1, dated February 1, 2018 (for Model 328-300 airplanes); as applicable: After replacement of the horizontal stabilizer rear bearing supports as required by paragraph (h) of this AD.
(2) For Group 2 airplanes as identified in 328 Support Services GmbH Service Bulletin SB-328-55-557, Revision 1, dated February 1, 2018 (for Model 328-100 airplanes); or 328 Support Services GmbH Service Bulletin SB-328J-55-324, Revision 1, dated February 1, 2018 (for Model 328-300 airplanes); as applicable: As of the effective date of this AD.
This paragraph provides credit for actions required by paragraph (g) of this AD, if those actions were performed before the effective date of this AD using 328 Support Services GmbH Service Bulletin SB-328-55-557, dated September 1, 2017 (for Model 328-100 airplanes); or 328 Support Services GmbH Service Bulletin SB-328J-55-324, dated September 1, 2017 (for Model 328-300 airplanes).
The following provisions also apply to this AD:
(1)
(2)
(1) Refer to Mandatory Continuing Airworthiness Information (MCAI) EASA Airworthiness Directive 2017-0239, dated November 30, 2017, for related information. This MCAI may be found in the AD docket on the internet at
(2) For more information about this AD, contact Todd Thompson, Aerospace Engineer, International Section, Transport Standards Branch, FAA, 2200 South 216th Street, Des Moines, WA 98198; telephone and fax 206-231-3228.
(3) For service information identified in this AD, contact 328 Support Services GmbH, Global Support Center, P.O. Box 1252, D-82231 Wessling, Federal Republic of Germany; telephone +49 8153 88111 6666; fax +49 8153 88111 6565; email
Food and Drug Administration, HHS.
Proposed rule; correction.
The Food and Drug Administration is correcting a proposed rule to amend its regulations concerning the classification of products as biological products, devices, drugs, or combination products, and their assignment to Agency components for premarket review and regulation that appeared in the
Submit either electronic or written comments on the proposed rule by July 16, 2018.
Melissa Burns, Office of Combination Products, Food and Drug Administration, 10903 New Hampshire Ave., Bldg. 32, Rm. 5129, Silver Spring, MD 20933, 301-796-8930,
In the
Postal Regulatory Commission.
Notice of proposed rulemaking.
The Commission is noticing a recent filing requesting that the Commission initiate an informal rulemaking proceeding to consider changes to an analytical method for use in periodic reporting (Proposal Two). This document 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 May 25, 2018, the Postal Service filed a petition pursuant to 39 CFR 3050.11 requesting that the Commission initiate a rulemaking proceeding to consider changes to analytical principles relating to periodic reports.
Under the cluster sampling design, the Postal Service proposes to use TACS workhours to weight sampling data by zone, and to provide cost controls for city carriers by time-of-day (morning and afternoon) and day-of-week group (weekday/Saturday group and Sunday/Holiday group).
The Postal Service asserts that the proposal adopts the approach suggested by the Commission in Order No. 4399 for developing route group weighting factors when there were “empty cells” within the combination of route group and carrier group.
Proposal Two would also “[u]se TACS data to provide control totals for the portion of supervisor costs incurred by employees whose base craft is carrier, but who have clocked as supervisor.”
The Postal Service projects that the IOCS-Cluster system will obtain twice as much on-premises data as the current system, but “due to the improvement in sampling efficiency, will not require additional data collection resources.”
The Postal Service lists several benefits of the proposal including the ability to scan barcodes, providing feedback at the time of the reading for less-common products and assisting with “back-end processing of tallies.”
The Postal Service states that the proposal will result in a significant increase in the percentage of direct tallies where the carrier is handling the mailpiece, and decreases in tallies for support and administrative activities, training, and mixed mail.
The Postal Service states that the pilot data indicate some significant shifts in product costs, including a decrease in costs for First-Class letters, and increases in costs for a number of products including parcel-shaped products, carrier route bundled products, Periodicals, and International Mail.
The Postal Service's estimate of the effect on product unit costs is presented in Table 5 of Proposal Two, which is reproduced here.
The Commission establishes Docket No. RM2018-5 for consideration of matters raised by the Petition. More information on the Petition may be accessed via the Commission's website at
1. The Commission establishes Docket No. RM2018-5 for consideration of the matters raised by the Petition of the
2. Comments by interested persons in this proceeding are due no later than July 16, 2018.
3. Pursuant to 39 U.S.C. 505, the Commission appoints Lyudmila Y. Bzhilyanskaya to serve as an officer of the Commission (Public Representative) to represent the interests of the general public in this docket.
4. The Secretary shall arrange for publication of this order in the
By the Commission.
Federal Communications Commission.
Proposed rule.
In this document, the Federal Communications Commission (Commission or FCC) seeks comment on proposed service rules on the 2.5 GHz band and on refinements to the adopted rules in this document.
Comments are due on or before July 9, 2018; reply comments are due on or before August 6, 2018.
You may submit comments, identified by WT Docket No. 18-120, by any of the following methods:
•
•
•
For detailed instructions for submitting comments and additional information on the rulemaking process, see the
John J. Schauble of the Wireless Telecommunications Bureau, Broadband Division, at 202-418-0797 or by email to
This is a summary of the Commission's
Pursuant to §§ 1.415 and 1.419 of the Commission's rules, 47 CFR 1.415, 1.419, interested parties may file comments and reply comments on or before the dates indicated on the first page of this document. Comments may be filed using the Commission's Electronic Comment Filing System (ECFS). See Electronic Filing of Documents in Rulemaking Proceedings, 63 FR 24121 (1998).
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•
Filings can be sent by hand or messenger delivery, by commercial overnight courier, or by first-class or overnight U.S. Postal Service mail. All filings must be addressed to the Commission's Secretary, Office of the Secretary, Federal Communications Commission.
• All hand-delivered or messenger-delivered paper filings for the Commission's Secretary must be delivered to FCC Headquarters at 445 12th St. SW, Room TW-A325, Washington, DC 20554. The filing hours are 8:00 a.m. to 7:00 p.m. All hand deliveries must be held together with rubber bands or fasteners. Any envelopes and boxes must be disposed of before entering the building.
• Commercial overnight mail (other than U.S. Postal Service Express Mail and Priority Mail) must be sent to 9050 Junction Dr., Annapolis Junction, Annapolis, MD 20701.
• U.S. Postal Service first-class, Express, and Priority mail must be addressed to 445 12th Street SW, Washington, DC 20554.
Pursuant to § 1.1200(a) of the Commission's rules, this
As required by the Regulatory Flexibility Act of 1980 (“RFA”), the Commission has prepared an Initial Regulatory Flexibility Analysis (“IRFA”) of the possible significant economic impact on a substantial number of small entities of the policies and rules proposed in the
This document contains proposed new or modified information collection requirements. The Commission, as part of its continuing effort to reduce paperwork burdens, invites the general public and the Office of Management and Budget (OMB) to comment on the information collection requirements contained in this document, as required by the Paperwork Reduction Act of 1995, Public Law 104-13. In addition, pursuant to the Small Business Paperwork Relief Act of 2002, Public Law 107-198, see 44 U.S.C. 3506(c)(4), the Commission seeks specific comment on how it might further reduce the information collection burden for small business concerns with fewer than 25 employees.
1. The 2.5 GHz band (2496-2690 MHz) constitutes the single largest band of contiguous spectrum below 3 gigahertz and has been identified as prime spectrum for next generation mobile operations, including 5G uses. Significant portions of this band, however, currently lie fallow across approximately one-half of the United States, primarily in rural areas. Moreover, access to the Educational Broadband Service (EBS) has been strictly limited since 1995, and current licensees are subject to a regulatory regime largely unchanged from the days when educational TV was the only use envisioned for this spectrum. The Commission proposes to allow more efficient and effective use of this spectrum band by providing greater flexibility to current EBS licensees as well as providing new opportunities for additional entities to obtain unused 2.5 GHz spectrum to facilitate improved access to next generation wireless broadband, including 5G. The Commission also seeks comment on additional approaches for transforming the 2.5 GHz band, including by moving directly to an auction for some or all of the spectrum.
2. EBS, formerly known as ITFS (Instructional Television Fixed Service), permits the transmission of instructional material for the formal education of students by accredited public and private schools, colleges, and universities.
3. Currently, eligibility to hold an EBS license is limited to (1) accredited public and private educational institutions, (2) governmental organizations engaged in the formal education of enrolled students, and (3) nonprofit organizations whose purposes are educational and include providing educational and instructional television materials to accredited institutions and governmental organizations. EBS licenses generally are held by state government agencies, state universities and university systems, public community and technical colleges, private universities and colleges, public elementary and secondary school districts, private schools (including Catholic school systems and other religious schools), public television and radio stations, hospitals and hospital associations, and other non-profit educational entities.
4. EBS licensees operate in 114 megahertz of the 2.5 GHz band; the remaining 80 megahertz is assigned to the Broadband Radio Service (BRS). EBS licensees are authorized to operate on the A, B, C, D, and G channel groups, with each group comprised of three 5.5 MHz channels in the lower or upper band segment and one 6 MHz channel in the mid-band segment. Since 1983 the Commission has allowed EBS licensees to lease their excess capacity to commercial providers, but it has required EBS licensees to retain five percent of their capacity for educational use, and it further has required that they use each channel at least 20 hours per week for educational purposes.
5. Currently, there are 1,300 EBS licensees holding over 2,190 licenses. EBS licenses generally are based on a 35-mile radius circular Geographic Service Area (GSA) (with an area of 1934 square miles), although due to a historical license modification process the Commission adopted in 2005, many EBS licenses have much smaller, irregular GSAs. Incumbent EBS licenses cover only about one half of the geographic area of the United States in any given channel. In the rest of the country, mostly rural areas west of the Mississippi River, the 2.5 GHz spectrum remains unassigned. There is some EBS spectrum unassigned in urban areas as well, but such spectrum generally is only available in small, irregularly shaped areas between GSAs that are considerably smaller than the area of a 35-mile radius circle.
6. The Commission suspended the processing of EBS applications in 1993. Only twice since then has the Commission opened filing windows for EBS applications. In 1995, the Commission provided a five-day window for the filing of applications for new construction permits and for major changes to existing EBS facilities. And in 1996, the Mass Media Bureau announced a sixty-day window for the filing of a limited class of applications, but during that window, it only permitted the filing of EBS modification applications and amendments to pending EBS applications proposing to co-locate with an authorized wireless cable facility.
7. During the past 20 years, the Commission, on several occasions, has considered assigning EBS spectrum licenses by auction. Most recently, the Commission in 2008 decided to use competitive bidding to license unassigned BRS spectrum but held that a “broader record should be developed on how to distribute licenses for unassigned EBS spectrum,” and it sought further comment on how to license unassigned EBS spectrum in the
8. In response to the
9. In accordance with the Commission's goal of making additional spectrum available for flexible use, and to promote use of 2.5 GHz frequencies that have been unassigned for far too long, the Commission proposes and seeks comment on a number of steps to encourage and facilitate more efficient use of this spectrum. First, given the irregularity of current EBS geographic service areas (as well as outdated regulatory requirements), the Commission proposes to rationalize existing EBS holdings so that existing licensees have new opportunities to put 2.5 GHz spectrum to its highest and best use. Second, the Commission seeks comment on whether to open one or more local priority filing windows so that existing licensees, Tribal Nations, and educational entities could get access to unassigned spectrum in the 2.5 GHz band. Third, the Commission proposes to use geographic area licensing to assign any remaining spectrum, which may result in the auction of any licenses for 2.5 GHz spectrum still unassigned after rationalizing holdings and any new filing windows. Finally, the Commission seeks comment on additional approaches for transforming the 2.5 GHz band, including by moving directly to an auction for some or all of the spectrum. The Commission believes the proposed changes discussed herein will reduce unnecessary regulatory burdens on licensees, promote greater spectrum efficiency, and facilitate the full use of EBS spectrum to provide advanced mobile broadband services, particularly in rural areas where this spectrum sits idle today.
10. Ensuring that the radio spectrum is used efficiently and intensively is an important public interest goal—a goal that also serves the interests of the existing licensees. The Commission traditionally has recognized that a spectrum policy based on flexible use in regular geographic areas has several advantages. Such flexible use licensing can promote broadband deployment, ensure the spectrum is put to its most beneficial use, allow licensees to respond to consumer demand for new services, and maximize the probability of success for new services.
11. As an initial step, the Commission proposes to rationalize the GSAs of existing EBS licensees, except grandfathered licensees in the E and F Channel groups, to a defined geographic area, namely, the sum of census tracts that are covered by, or that intersect, a licensee's existing GSA. The Commission proposes that such rationalization should occur automatically (
12. The Commission seeks comment on whether such expansion should include every census tract that is covered by or that intersects the licensee's existing GSA. Alternatively, should a census tract be included only if a minimum percentage of that census tract overlaps the GSA, and, if so, what should that minimum percentage threshold be (
13. Second, the Commission proposes that, in this rationalization process, each current EBS GSA will be converted to a single license made up of all the census tracts it covers or intersects, rather than converted to a collection of separate licenses, each the size of a single census tract. The Commission seeks comment on this proposal.
14. Finally, the Commission seeks comment on how to resolve situations in which two or more co-channel GSAs overlap the same census tract(s), and whether simply setting the threshold for required overlap at 50 percent in order to include the census tract in the GSA is the best way to address such a situation. Are there other ways to address situations in which co-channel GSAs overlap the same census tracts?
15. Modifying EBS licenses to GSAs based on census tracts should generate two particular benefits. First, since census tract boundaries are pre-determined and follow regular geographic separation patterns (
16. Second, rationalizing incumbent EBS licenses based on census tracts would yield white spaces that also are based on the boundaries of census tracts and/or counties (since census tracts nest into counties), rather than irregular shapes and slivers. This regularity in the shape and size of white spaces would facilitate new entry into the 2.5 GHz band. The Commission seeks comment on these views. Commenters should discuss the costs and benefits of such a license area change.
17. As an alternative to basing GSAs on census tracts, the Commission seeks comment on whether the Commission should expand existing GSAs to include the counties covered by or that intersect the GSA. Under this alternative, the Commission seeks comment on whether to include a county only if a minimum percentage of the county overlaps the GSA and, if so, what that minimum percentage should be (
18. The Commission also seeks comment on any other issue that may arise from rationalizing existing EBS
19. Granting additional flexibility to EBS licensees has been an effective means of allowing better use of the 2.5 GHz band. In 1983, when the Commission allowed 2.5 GHz licensees to lease excess capacity, it provided educators with another means of acquiring the resources needed to operate Instructional Television Fixed Source (ITFS) facilities for education. In 2004, when the Commission created BRS and EBS, the more flexible technical rules allowed the bands to be used for broadband services. Now, significant amounts of commercial broadband data flow through the 2.5 GHz band. The Commission believes subsequent events have confirmed the Commission's prediction that “consumer benefits will be maximized if BRS/EBS licensees are able to take advantage of the flexible use standard in Part 27.” The Commission now seeks comment on granting additional flexibility to EBS licensees in order to promote more intensive and efficient spectrum use.
20. First, the Commission proposes to provide EBS licensees with the flexibility to assign or transfer control of their licenses to entities that are not EBS-eligible. Specifically, the Commission proposes to eliminate the limit on what entities can hold EBS licenses (rule 27.1201) and make clear that licensees may assign or transfer control of their licenses to other entities. The Commission notes that the existing licensees have built out their systems since 2011 and understand how they use their EBS licenses as well as the availability of wireless broadband in their area. Under this proposal, the decision whether to lease or transfer a license would rest with the EBS licensee.
21. EBS licensees whose licenses were granted via waiver since the EBS filing freeze was instituted are currently prohibited from leasing the spectrum. Consistent with our consideration of providing additional secondary-markets flexibility to existing EBS licensees, the Commission proposes to eliminate any special restrictions on such licensees; accordingly, those whose licenses were granted via waiver would have the same flexibility to lease their spectrum or to transfer or assign their licenses as the Commission proposes for other EBS licensees. The Commission seeks comment on this proposal.
22. The Commission also seeks comment on eliminating the educational use requirements for EBS licensees. The educational use requirements, which have not been updated since 1998 were based on the use of analog video and permitted many administrative uses to fulfill the educational requirement. However, most EBS licensees or their commercial lessees are providing digital broadband service, offered 24/7, at the school itself, at home, or anywhere within the licensee's GSA. It appears the existing educational use requirements are out of date and do not fit the actual use of the spectrum. Given the additional flexibility the Commission is granting EBS licensees, the Commission seeks comment on whether there is value in attempting to update the educational use requirements—who is better positioned to determine the highest and best use of 2.5 GHz spectrum, the Commission or licensees? Commenters should explain and quantify the benefits and costs of these regulatory requirements, including whether to update them (and if so, how).
23. The Commission also proposes to eliminate the current restrictions on EBS lease terms. Under existing rules, EBS licensees are prohibited from leasing their facilities for a term longer than 30 years and lessees are required to provide EBS lessors with the opportunity to revisit their lease terms at years 15, 20, and 25 to review their “educational use requirements in light of changes in educational needs, technology, and other relevant factors and to obtain access to such additional services, capacity, support, and/or equipment as the parties shall agree upon in the spectrum leasing arrangement to advance the EBS licensee's educational mission.” To that end, the Commission proposes to eliminate these lease restrictions on a going-forward basis.
24. Finally, the Commission asks whether, in light of the actions the Commission takes in this proceeding, it should modify our treatment of EBS in the spectrum screen. In the
25. Once the Commission has rationalized the holdings of existing
26. When the Commission reopened applications for the 2.5 GHz band in 1985, it expressed a “strong preference” for local applicants in the licensing process. The Commission found then that local applicants were “convincingly demonstrated . . . to be the best authorities for evaluating their educational needs and the needs of others they propose to serve in their communities,” to “best understand the educational needs . . . of their communities,” and to “act most responsibly in designing and developing [2.5 GHz] systems.” It thus opened a “local priority period” to give “more local entities . . . the opportunity to fill more channels as financial support from non-[instructional] use becomes more widespread.”
27. Now that the Commission is again opening the 2.5 GHz band for additional licensing, the Commission starts by seeking comment on whether the Commission should open up to three new filing windows for qualifying applicants that want to use currently unassigned 2.5 GHz spectrum to serve their local communities. In each filing window, qualifying applicants would have the opportunity to apply for one or more vacant channels of EBS spectrum in areas where the applicant can show it has a local presence. The first filing window would be for existing EBS licensees, the second for Tribal Nations, and the third for other educational entities. The Commission seeks comment on whether the Commission should open any new local priority filing windows, if any, as well as the details of such windows in turn.
28. In responding, commenters should discuss whether such priority filing windows to assign licenses is consistent with our statutory authority to assign licenses that could be used for telecommunications, and Commission policy and precedent regarding use of competitive bidding. Also, should these entities be given preference over others, in light of other benefits provided to these entities, such as various Universal Service programs, including E-Rate and the Connect America Fund? The Commission also seeks comment on whether such filing windows can be misused and result in unjust enrichment, with licenses being sold or leased to ineligible entities for profit. What effect might these priority windows have on the attractiveness of the remaining spectrum for other applicants? Should the Commission have one combined priority window for these entities, or the three the Commission seeks comment on below?
29.
30. Commenters also should address what documentation applicants must provide to make such a demonstration. Should the determination of whether an applicant is considered to have a local presence be based solely on an applicant's physical location(s) and/or physical address(es)? Commenters should discuss other factors that should be considered and explain how any factors that they suggest will ensure that the local priority filing window is available only to local applicants. The Commission also seeks comment any other issues that it may need to address to implement a local presence requirement.
31. The Commission notes that the majority of current EBS licensees, such as school districts, schools, colleges and universities, appear to have a local presence where they have licenses. It also appears that the entities most likely to be affected by a local presence requirement are the “national” licensees. Although national licensees serve a purpose in providing educational services to educational institutions and students, educational entities with a local presence have a closer understanding of the needs of their local communities and are more likely to use 2.5 GHz spectrum to meet such needs, especially in rural areas. Entities with a local presence are part of the communities they wish to serve, and requiring local presence would increase the likelihood that the EBS spectrum would be put to beneficial use for local communities. The Commission seeks comment on these views.
32.
33. Were the Commission to open such a window, it would propose to limit participation to existing licensees as of the adoption of this
34. What other conditions, if any, should the Commission adopt on participants in such a window? For example, should the Commission exclude channels in counties in which more than one existing licensee would qualify for expansion on a single channel? If so, how would the Commission determine all counties in which existing licensees meet the local presence requirement? Alternatively, should the Commission only exclude channels in counties in which more than one licensee holds licenses covering at least 25 percent of the census tracts in the county? Should the Commission exclude tribal areas that are contained within a county that would be subject to the Tribal Nations window discussed below? The Commission seeks comment on these and any other issues related to opening a new local priority filing window for existing licensees.
35.
36. Were the Commission to open such a window, it would propose to limit participation to federally-recognized American Indian Tribes and Alaska Native Villages located in rural areas.
37. The Commission next seeks comment on whether licenses granted for white spaces in such a local priority window should be at the county level or on a census-tract-by-census-tract basis. Commenters should discuss why a particular geographic area size would be appropriate taking into account all relevant information, including border interference coordination needs, propagation characteristics of the band, and the services that will be offered. The Commission notes that using a smaller license area (census tracts) would increase the fit between areas licensed to Tribal Nations and Tribal lands, but may have offsetting efficiency losses. Commenters should discuss the costs and benefits of any advocated approach and support their position with quantitative and qualitative data.
38. The Commission also proposes that, if it were to adopt such a local priority filing window, it would not limit the number of channels that a Tribal Nation could acquire. Given the state of wireless technologies (including the use of progressively wider channels), the Commission believes that allowing access to contiguous spectrum on any number of available channels would more efficiently accommodate varying business models and spectrum needs for wireless broadband. The Commission seeks comment on this proposal.
39. Finally, the Commission seeks comment on any other ways by which it could encourage the use of 2.5 GHz spectrum on Tribal Lands. Should the Commission impose any additional obligations to ensure that Tribal Nations hold 2.5 GHz licenses for the benefit of their Tribal community? The Commission seeks comment on these and any other issues related to opening a new local priority filing window for
40.
41. Were the Commission to open such a window, it would propose to limit participation to accredited institutions as well as governmental organizations engaged in the formal education of enrolled students who are not 2.5 GHz licensees as of the adoption of this
42. The Commission next seeks comment on whether licenses granted for white spaces in such a local priority window should be at the county level or on a census-tract-by-census-tract basis. Commenters should discuss why a particular geographic area size would be appropriate taking into account all relevant information, including border interference coordination needs, propagation characteristics of the band, and the services that will be offered. Since a number of school districts are based on county boundaries, would allowing county-based licenses allow county-based school districts to better provide services to the students within their districts, and in many cases, to provide services to those students at home, as well as on school premises? Commenters should discuss the costs and benefits of any advocated approach and support their position with quantitative and qualitative data.
43. The Commission also proposes that, if it were to adopt such a local priority filing window, it would not limit the number of channels that a new educational entity could acquire. Given the state of wireless technologies (including the use of progressively wider channels), the Commission believes that allowing access to contiguous spectrum on any number of available channels would more efficiently accommodate varying business models and spectrum needs for wireless broadband. The Commission seeks comment on this proposal.
44.
45.
46. The also seeks comment on whether to allow a settlement window for the filers to resolve any mutual exclusivity before the Commission accept any application for a 2.5 GHz license. The Commission also seeks comment on any alternative “engineering solutions, negotiation, threshold qualifications, service regulations, and other means”
47.
48. For EBS licenses granted via the local priority windows proposed above, the Commission proposes to require that licensees must reserve a minimum of 20 percent of the capacity of their channels for educational uses that “further the educational mission of accredited public and private schools” consistent with paragraphs (b) and (c) of § 27.1203 of the Commission's rules and may not enter into spectrum leasing arrangements involving this reserved capacity. For EBS licensees that choose to provide a broadcast-type service, the Commission proposes to require such licensees to offer 20 hours per channel, per week of educational programming. The Commission seeks comment on these proposals.
49. The Commission proposes, after any new licenses have been assigned through one or more local priority filing windows should the Commission choose to implement that approach, that any remaining 2.5 GHz spectrum
50. The Commission seeks comment on the appropriate geographic size of new 2.5 GHz white space licenses (
51. Consistent with our longstanding approach, the Commission would initiate a public notice process to solicit public input on certain details of auction design and the auction procedures. This public notice process would address auction-specific matters such as the competitive bidding design and mechanisms, minimum opening bids and/or reserve prices, caps on bidding credits, and payment procedures. In advance of the auction, another public notice would announce the auction procedures and provide detailed instructions for potential auction participants. The Commission also seeks comment on whether any of our part 1 rules should be modified for an auction of licenses in these frequency bands.
52. The current performance requirements for licensees in the 2.5 GHz band were set forth in 2006, as part of the ongoing efforts to transition the band to the new band plan established in 2004. The
53. Last year, the Commission adopted a unified regulatory framework for the Wireless Radio Services (WRS) that replaced the existing patchwork of service-specific rules regarding renewal, comparative renewal, continuity of service, and partitioning and disaggregation, with clear, consistent rules of the road for WRS licensees. The Commission included BRS in the new WRS framework, but excluded EBS from the WRS framework on the ground that “this service presents unique issues that are under consideration in” this present proceeding.
54.
55.
56. The process for transitioning BRS and EBS licensees to the new band plan was completed in 2011. While a few Multichannel Video Programming Distributors have received waivers to opt out of the transition so that they can continue providing service, all other licensees have transitioned to the new band plan. It therefore appears that the transition rules are no longer necessary.
57. The Commission also proposes to make various non-substantive, clarifying amendments to § 27.1206. The proposed changes are contained in the Proposed Rules. The changes are designed to make the rules easier to understand without changing the substantive requirements for BRS. The Commission seeks comment on these proposed changes.
58. The Commission seeks comment on other approaches to rationalizing and opening up the 2.5 GHz band for more productive and intensive use. Generally, are there better ways to restructure the 2.5 GHz band that will ensure that it is put to its highest and best use? In particular, the Commission seeks comment on other licensing and auction ideas and alternatives to the local priority filing window approach. Commenters should provide information about the costs and benefits of any approach suggested.
59. For instance, should the Commission, regardless of the scope of incumbent operations, create new geographic area licenses? If so, what types of geographic area licenses should the FCC create? Should the Commission license the spectrum based on census tracts or counties or some other size? Commenters should discuss whether their view of the appropriate geographic area size changes if the Commission is considering licenses that encompass more than the white spaces previously discussed, and if so why. Additionally, what channel size or sizes should the Commission use in licensing this spectrum?
60. If the FCC were to adopt this approach, how would the Commission account for reasonable investment-backed expectations and incumbent operations? Would a different approach than those considered in section III.A. above be preferable, and if so why? For example, should the Commission convert incumbent licenses into new, flexible use spectrum licenses that would be subject to its secondary market rules? If so, how? Should our approach to incumbent licensees depend on or consider the existing and/or historic use of the spectrum by those incumbent licensees, including, for instance, the construction of facilities or degree to which the spectrum has consistently been put to use?
61. Should the Commission consider moving directly to auction for this spectrum, rather than open priority filing windows for certain entities? In section III.B.2, the Commission seeks comment on auctioning the white spaces, but, instead, should the Commission consider other auction options, such as an incentive auction of this spectrum in order to provide incentives for incumbents to make underutilized spectrum available for commercial use? In particular, should the Commission rely on § 6402 of the Spectrum Act, now codified at 47 U.S.C. 309(j)(8)(G) (or some other source of authority) to encourage incumbent licensees to relinquish voluntarily some or all of their spectrum usage rights to permit the assignment of new initial licenses subject to flexible-use service rules? Are there other means of assigning licenses and promoting more efficient uses that the Commission should consider, such as an overlay auction
62. Regardless of the particular approach the Commission takes to facilitate more intensive use of the 2.5 GHz spectrum, should the Commission allow all entities that are interested in using this spectrum the same opportunity to acquire licenses in this band? In other words, should the Commission not adopt local priority filing windows or otherwise grant preferential treatment to potential licensees based on their identity or other criteria?
63. As required by the Regulatory Flexibility Act of 1980, as amended (RFA), the Commission has prepared this Initial Regulatory Flexibility Analysis (IRFA) of the possible significant economic impact on a substantial number of small entities by the policies and rules proposed in the
64. In the
65. The proposed actions are authorized pursuant to Sections 1, 2, 3, 4(i), 7, 201, 301, 302, 303, 304, 307, 308, 309, and 310 of the Communications Act of 1934, as amended, 47 U.S.C. 151, 152, 154(i), 157, 201, 301, 302, 303, 304, 307, 308, 309, 310 and Section 706 of the Telecommunications Act of 1996, as amended, 47 U.S.C. 1302.
66. The RFA directs agencies to provide a description of, and, where feasible, an estimate of the number of small entities that may be affected by the proposed rules and policies, if adopted. The RFA generally defines the term “small entity” as having the same meaning as the terms “small business,” “small organization,” and “small governmental jurisdiction.” In addition, the term “small business” has the same meaning as the term “small business concern” under the Small Business Act. A “small business concern” is one which: (1) Is independently owned and operated; (2) is not dominant in its field of operation; and (3) satisfies any additional criteria established by the SBA.
67.
68. Next, the type of small entity described as a “small organization” is generally “any not-for-profit enterprise which is independently owned and operated and is not dominant in its field.” Nationwide, as of August 2016, there were approximately 356,494 small organizations based on registration and tax data filed by nonprofits with the Internal Revenue Service (IRS).
69. Finally, the small entity described as a “small governmental jurisdiction” is defined generally as “governments of cities, counties, towns, townships, villages, school districts, or special districts, with a population of less than fifty thousand.” U.S. Census Bureau data from the 2012 Census of Governments indicate that there were 90,056 local governmental jurisdictions consisting of general purpose governments and special purpose governments in the United States. Of this number there were 37,132 General purpose governments (county, municipal and town or township) with populations of less than 50,000 and 12,184 Special purpose governments (independent school districts and special districts) with populations of less than 50,000. The 2012 U.S. Census Bureau data for most types of governments in the local government category show that the majority of these governments have populations of less than 50,000. Based on this data the Commission estimates that at least 49,316 local government jurisdictions fall in the category of “small governmental jurisdictions.”
70.
71.
72.
73. In 2009, the Commission conducted Auction 86, the sale of 78 licenses in the BRS areas. The Commission offered three levels of bidding credits: (i) A bidder with attributed average annual gross revenues that exceed $15 million and do not exceed $40 million for the preceding three years (small business) received a 15 percent discount on its winning bid; (ii) a bidder with attributed average annual gross revenues that exceed $3 million and do not exceed $15 million for the preceding three years (very small business) received a 25 percent discount on its winning bid; and (iii) a bidder with attributed average annual gross revenues that do not exceed $3 million for the preceding three years (entrepreneur) received a 35 percent discount on its winning bid. Auction 86 concluded in 2009 with the sale of 61 licenses. Of the ten winning bidders, two bidders that claimed small business status won 4 licenses; one bidder that claimed very small business status won three licenses; and two bidders that claimed entrepreneur status won six licenses.
74.
75. In addition to Census data, the Commission's Universal Licensing System indicates that as of March 2018 there are 1,300 licensees holding over 2,190 active EBS licenses. The Commission estimates that of these 2,190 licenses, the majority are held by non-profit educational institutions and school districts, which are by statute defined as small businesses.
76. The Commission expects the rules proposed in the
77.
78.
79.
80.
81.
82.
83.
84.
85.
86.
87.
88.
89.
90. The RFA requires an agency to describe any significant, specifically small business, alternatives that it has considered in reaching its proposed approach, which may include the following four alternatives (among others): “(1) the establishment of differing compliance or reporting requirements or timetables that take into account the resources available to small entities; (2) the clarification, consolidation, or simplification of compliance and reporting requirements under the rule for such small entities; (3) the use or performance rather than design standards; and (4) an exemption from coverage of the rules, or any part thereof, for such small entities.”
91. The Commission does not believe that its proposed changes will have a significant economic impact on small entities however, to get a better understanding costs and benefits associated with proposals and any alternatives raised in this proceeding as mentioned above in the previous section, the Commission has requested that commenters discuss the costs and benefits supported by quantitative and qualitative data of any approach advocated. The proposed changes expanding the use of the 2.5 GHz band will benefit small entities as well as entities of other sizes by reducing unnecessary regulatory burdens on licensees, promoting greater spectrum efficiency, and facilitating the full use of EBS spectrum to provide advanced mobile broadband services, particularly in rural areas where this spectrum sits idle today. Moreover, the proposed reforms will permit more flexible use of this spectrum by small and other sized entities that currently hold EBS licenses and will provide new opportunities for EBS eligible entities, Tribal Nations, and
92. More specifically, the Commission's proposed rationalization process for incumbent EBS licensees that would occur automatically allowing incumbent licensees to avoid a requirement to file applications with the Commission or to otherwise notify the Commission to effectuate this change would minimize some costs and/or administrative burdens on small entities associated with the rule, if adopted. Small entities should also benefit from removal of the filing freeze for new EBS licenses and the requirement that EBS eligible entities applying for a new license must have a local presence in the areas in which they wish to provide service, which will provide them greater opportunity to obtain EBS spectrum to meet the needs of their communities. In addition, small entities should benefit from the increased flexibility of our proposal to allow EBS licensees with the flexibility to assign or transfer control of their licenses to entities that are not EBS-eligible. The Commission believes that, at this point in time, licensees are in the best position to determine how to use their licenses, or, alternatively, whether to transfer their licenses to a third party in the secondary market.
93. For existing EBS licenses the Commission's action declining to issue proposals creating new performance or renewal requirements will spare small entities and other existing EBS licensees the costs of new compliance requirements in these areas. With respect to performance requirements adopted for all new EBS licenses, the Commission believes such requirements are necessary to ensure that spectrum is being put into use and has proposed a variety of metrics to provide small entities as well as other licensees with a variety of means by which they may demonstrate compliance. The Commission anticipates that updating the performance requirements in this manner will encourage rapid deployment of next generation wireless services, including 5G, which will benefit small entities and the industry as a whole.
94. None.
95.
96.
97.
Communications common carriers, Communications equipment, Reporting and recordkeeping requirements.
For the reasons discussed in the preamble, the Federal Communications Commission proposes to amend 47 CFR parts 1 and 27 as follows:
47 U.S.C. 151, 154(i), 155, 157, 160, 201, 225, 227, 303, 309, 332, 1403, 1404, 1451, 1452, and 1455, unless otherwise noted.
(c)
47 U.S.C. 154, 301, 302a, 303, 307, 309, 332, 336, 337, 1403, 1404, 1451, and 1452, unless otherwise noted.
(o)(1) All BRS and EBS licensees issued after [effective date of final rule], must demonstrate compliance with the performance requirements described in this paragraph. All equipment used to demonstrate compliance must be in use and actually providing service, either for internal use or to unaffiliated customers, as of the interim deadline or the end of the license term, whichever is applicable.
(2) Licensees relying on mobile service must demonstrate reliable signal coverage of 50% of the population of the geographic service area by the interim deadline, and 80% of the population of the geographic service area by the end of the license term.
(3) Licensees relying on fixed service must demonstrate operation of one link for each 50,000 persons in the geographic service area by the interim deadline, and one link for each 25,000 persons in the geographic service area by the end of the license term.
(a) BRS:
(1) For BRS incumbent licenses granted before September 15, 1995, the GSA for a channel is the GSA as created on January 10, 2005.
(2) For BRS BTA authorization holders, the GSA for a channel is the
(3) If an incumbent BRS license is cancelled or is forfeited, the GSA area of the incumbent station shall dissolve and the right to operate in that area automatically reverts to the GSA licensee that held the corresponding BTA.
(b) For EBS:
(1)
(ii) For EBS licenses not in the E and F channel groups in effect as of [effective date of final rule], the GSA for a channel consists of all census tracts which are covered by or intersect its GSA existing as of [effective date of final rule].
(2)
(a) All leases of current EBS spectrum entered into prior to January 10, 2005 and in compliance with leasing rules formerly contained in part 74 of this chapter may continue in force and effect, notwithstanding any inconsistency between such leases and the rules applicable to spectrum leasing arrangements set forth in this chapter. Such leases entered into pursuant to the former part 74 rules of this chapter may be renewed and assigned in accordance with the terms of such lease. All spectrum leasing arrangements leases entered into after January 10, 2005, pursuant to the rules set forth in part 1 and part 27 of this chapter, must comply with the rules in those parts.
(b) For leasing arrangements entered into between July 19, 2006 and [effective date of final rule], the maximum permissible term of an EBS spectrum leasing arrangement (including the initial term and all renewal terms that commence automatically or at the sole option of the lessee) shall be 30 years. Any spectrum leasing arrangement in excess of 15 years that is entered into on or after July 19, 2006 and before [effective date of final rule] must include terms which provide the EBS licensee on the 15th year and every 5 years thereafter, with an opportunity to review its educational use requirements in light of changes in educational needs, technology, and other relevant factors and to obtain access to such additional services, capacity, support, and/or equipment as the parties shall agree upon in the spectrum leasing arrangement to advance the EBS licensee's educational mission.
Mutually exclusive initial applications for BRS and EBS licenses are subject to competitive bidding. The designated entity provisions in § 27.1218 shall not apply to auctions held after [effective date of final rule]. The general competitive bidding procedures set forth in part 1, subpart Q of this chapter will apply unless otherwise provided in this subpart.
Animal and Plant Health Inspection Service, USDA.
Notice.
We are advising the public of our determination that Japan is free of classical swine fever (CSF) and swine vesicular disease (SVD). Based on an evaluation of the CSF and SVD status of Japan, which we made available to the public for review and comment through a previous notice, the Administrator has determined that CSF and SVD are not present in Japan and that live swine, pork, and pork products may safely be imported into the United States from Japan subject to conditions in the regulations.
This change in Japan's CSF and SVD status will be recognized on July 9, 2018.
Dr. Kelly Rhodes, Senior Staff Veterinarian, Regionalization Evaluation Services, National Import Export Services, VS, APHIS, USDA, 4700 River Road Unit 38, Riverdale, MD 20737-1231; email:
The regulations in 9 CFR part 94 (referred to below as the regulations) govern the importation of certain animals and animal products into the United States in order to prevent the introduction of various animal diseases, including classical swine fever (CSF) and swine vesicular disease (SVD). These are dangerous and communicable diseases of swine.
Within part 94, § 94.9 contains requirements governing the importation of pork and pork products from regions where CSF exists. Section 94.10 contains importation requirements for swine from regions where CSF is considered to exist. Section 94.12 contains requirements governing the importation of pork or pork products from regions where SVD exists. Section 94.14 prohibits the importation of domestic swine which are moved from or transit any region in which SVD is known to exist.
In accordance with §§ 94.9(a)(1) and 94.10(a)(1), the Animal and Plant Health Inspection Service (APHIS) maintains a web-based list of regions which the Agency considers free of CSF. Sections 94.9(a)(2) and 94.10(a)(2) state that APHIS will add a region to this list after it conducts an evaluation of the region and finds that CSF is not present.
Similarly, in accordance with § 94.12(a)(1), APHIS maintains a web-based list of regions which the Agency considers free of SVD. Paragraph (a)(2) of this section states that APHIS will add a region to this list after it conducts an evaluation of the region and finds that SVD is not present.
The regulations in § 92.2 contain requirements for requesting the recognition of the animal health status of a region (as well as for the approval of the export of a particular type of animal or animal product to the United States from a foreign region). If, after review and evaluation of the information submitted in support of the request, APHIS believes the request can be safely granted, APHIS will make its evaluation available for public comment through a document published in the
In accordance with that process, Japan requested that APHIS evaluate the CSF and SVD disease status of the country. Based on our evaluation, we determined that Japan is free of both CSF and SVD and that the surveillance, prevention, and control measures implemented by Japan are sufficient to minimize the likelihood of introducing CSF and SVD into the United States via imports of species or products susceptible to these diseases.
On February 20, 2018, we published in the
Therefore, based on the findings of our evaluation and the absence of comments that would lead us to reconsider those findings, we are announcing our determination to add Japan to the list of regions declared free of CSF and the list of regions declared free of SVD. These lists are available on the APHIS website at
7 U.S.C. 450, 7701-7772, 7781-7786, and 8301-8317; 21 U.S.C. 136 and 136a; 31 U.S.C. 9701; 7 CFR 2.22, 2.80, and 371.4.
Animal and Plant Health Inspection Service, USDA.
Notice.
We are advising the public that the Animal and Plant Health Inspection Service has prepared a preliminary determination regarding a request from Bayer CropScience LP seeking a determination of nonregulated status for cotton designated as event GHB811, which has been genetically engineered for dual resistance to HPPD-inhibitor herbicides (
We will consider all comments that we receive on or before July 9, 2018.
You may submit comments by either of the following methods:
•
•
The draft environmental assessment, preliminary regulatory determination, preliminary finding of no significant impact, preliminary plant pest risk assessment, and any comments we receive on this docket may be viewed at
Supporting documents for this petition are also available on the APHIS website at
Dr. John Turner, Director, Environmental Risk Analysis Programs, Biotechnology Regulatory Services, APHIS, 4700 River Road, Unit 147, Riverdale, MD 20737-1236; (301) 851-3954, email:
Under the authority of the plant pest provisions of the Plant Protection Act (7 U.S.C. 7701
The regulations in § 340.6(a) provide that any person may submit a petition to the Animal and Plant Health Inspection Service (APHIS) seeking a determination that an article should not be regulated under 7 CFR part 340. APHIS received a petition (APHIS Petition Number 17-138-01p) from Bayer CropScience LP (Bayer) of Research Triangle Park, NC, seeking a determination of nonregulated status of cotton (
According to our process
After public comments are received on a completed petition, APHIS evaluates those comments and then provides a second opportunity for public involvement in our decisionmaking process. According to our public review process (see footnote 1), the second opportunity for public involvement follows one of two approaches, as described below.
If APHIS decides, based on its review of the petition and its evaluation and analysis of comments received during the 60-day public comment period on the petition, that the petition involves a GE organism that raises no substantive new issues, APHIS will follow Approach 1 for public involvement. Under Approach 1, APHIS announces in the
Had APHIS decided, based on its review of the petition and its evaluation and analysis of comments received during the 60-day public comment period on the petition, that the petition involves a GE organism that raises substantive new issues, APHIS would follow Approach 2. Under Approach 2, APHIS first solicits written comments from the public on a draft EA and preliminary PPRA for a 30-day comment period through the publication of a
As part of our decisionmaking process regarding a GE organism's regulatory status, APHIS prepares a PPRA to assess the plant pest risk of the article. APHIS also prepares the appropriate environmental documentation—either an EA or an environmental impact statement—in accordance with NEPA, to provide the Agency and the public with a review and analysis of any potential environmental impacts that may result if the petition request is approved.
APHIS has prepared a preliminary PPRA and has concluded that cotton designated as event GHB811, which has been genetically engineered for dual herbicides resistance, is unlikely to pose a plant pest risk. In section 403 of the Plant Protection Act, “plant pest” is defined as any living stage of any of the following that can directly or indirectly injure, cause damage to, or cause disease in any plant or plant product: A protozoan, a nonhuman animal, a parasitic plant, a bacterium, a fungus, a virus or viroid, an infectious agent or other pathogen, or any article similar to or allied with any of the foregoing.
APHIS has also prepared a draft EA in which we present two alternatives based on our analysis of data submitted by Bayer, a review of other scientific data, field tests conducted under APHIS oversight, and comments received on the petition. APHIS is considering the following alternatives: (1) Take no action,
The draft EA was prepared in accordance with (1) NEPA, as amended (42 U.S.C. 4321
Based on APHIS' analysis of field and laboratory data submitted by Bayer, references provided in the petition, peer-reviewed publications, information analyzed in the draft EA, the preliminary PPRA, comments provided by the public on the petition, and discussion of issues in the draft EA, APHIS has determined that cotton designated as event GHB811 is unlikely to pose a plant pest risk. We have therefore reached a decision to make a preliminary determination of nonregulated status of cotton designated as event GHB811, whereby cotton designated as event GHB811 would no longer be subject to our regulations governing the introduction of certain GE organisms.
We are making available for a 30-day review period APHIS' preliminary regulatory determination of cotton designated as event GHB811, along with our preliminary PPRA, draft EA, and preliminary FONSI for the preliminary determination of nonregulated status. The draft EA, preliminary FONSI, preliminary PPRA, and our preliminary determination for cotton designated as event GHB811, as well as the Bayer petition and the comments received on the petition, are available as indicated under
After the 30-day review period closes, APHIS will review and evaluate any information received during the 30-day review period. If, after evaluating the information received, APHIS determines that we have not received substantive new information that would warrant APHIS altering our preliminary regulatory determination or preliminary FONSI, substantially changing the proposed action identified in the draft EA, or substantially changing the analysis of impacts in the draft EA, APHIS will notify the public through an announcement on our website of our final regulatory determination. If, however, APHIS determines that we have received substantive new information that would warrant APHIS altering our preliminary regulatory determination or preliminary FONSI, substantially changing the proposed action identified in the draft EA, or substantially changing the analysis of impacts in the draft EA, then APHIS will conduct the additional analysis and prepare an amended EA, a new FONSI, and/or a revised PPRA, which would be made available for public review in a subsequent notice in the
7 U.S.C. 7701-7772 and 7781-7786; 31 U.S.C. 9701; 7 CFR 2.22, 2.80, and 371.3.
U.S. Commission on Civil Rights.
Announcement of meeting.
Notice is hereby given, pursuant to the provisions of the rules and regulations of the U.S. Commission on Civil Rights (Commission) and the Federal Advisory Committee Act (FACA) that a meeting of the Idaho Advisory Committee (Committee) to the Commission will be held at 1:00 p.m. (Mountain Time) Wednesday, June 20, 2018, for the purpose of discussing potential civil rights topics of study.
The meeting will be held on Wednesday, June 20, 2018, at 1:00 p.m. MT.
Angelica Trevino at
This meeting is available to the public through the following toll-free call-in number: 877-675-4751, conference ID number: 5522721. Any interested member of the public may call this number and listen to the meeting. Callers can expect to incur charges for calls they initiate over wireless lines, and the Commission will not refund any incurred charges. Callers will incur no charge for calls they initiate over land-line connections to the toll-free telephone number. Persons with hearing impairments may also follow the proceedings by first calling the Federal Relay Service at 1-800-877-8339 and providing the Service with the conference call number and conference ID number.
Members of the public are entitled to make comments during the open period at the end of the meeting. Members of the public may also submit written comments; the comments must be received in the Regional Programs Unit within 30 days following the meeting. Written comments may be mailed to the Western Regional Office, U.S. Commission on Civil Rights, 300 North Los Angeles Street, Suite 2010, Los Angeles, CA 90012. They may be faxed to the Commission at (213) 894-0508, or emailed Angelica Trevino at
Records and documents discussed during the meeting will be available for
Commission on Civil Rights.
Announcement of monthly planning meetings.
Notice is hereby given, pursuant to the provisions of the rules and regulations of the U.S. Commission on Civil Rights (Commission), and the Federal Advisory Committee Act (FACA), that a planning meeting of the Massachusetts Advisory Committee to the Commission will convene on Thursday, June 28, 2017 at 1:00 p.m. (EDT) at McCarter & English, LLP, 265 Franklin Street, Boston, MA 02110. The purpose of the meeting is project planning so that members can begin discussing potential topics for its civil rights project.
Thursday, June 28, 2018 (EDT) at 1:00 p.m. (EDT).
McCarter & English, LLP, 265 Franklin Street, Boston, MA 02110.
Evelyn Bohor, at
If other persons who plan to attend the meeting require other accommodations, please contact Evelyn Bohor at
Records and documents discussed during the meeting will be available for public viewing as they become available at
Commission on Civil Rights.
Announcement of meetings.
Notice is hereby given, pursuant to the provisions of the rules and regulations of the U.S. Commission on Civil Rights (Commission), and the Federal Advisory Committee Act (FACA), that planning meetings of the South Dakota Advisory Committee to the Commission will convene at 5:00 p.m. (MDT) on Tuesday, June 26, 2018 via teleconference. The purpose of the meeting is to review logistics and possible presenters at two community briefings to be held in Pine Ridge and Pierre, South Dakota in July 2018.
Tuesday, June 26, 2018, at 5:00 p.m. (MDT).
To be held via teleconference:
Evelyn Bohor,
Members of the public may listen to the discussion by dialing the following Conference Call Toll-Free Number: 1-800-310-7032; Conference ID: 3590626. Please be advised that before being placed into the conference call, the operator will ask callers to provide their names, their organizational affiliations (if any), and an email address (if available) prior to placing callers into the conference room. Callers can expect to incur charges for calls they initiate over wireless lines, and the Commission will not refund any incurred charges. Callers will incur no charge for calls they initiate over land-line connections to the toll-free phone number.
Persons with hearing impairments may also follow the discussion by first calling the Federal Relay Service (FRS) at 1-800-877-8339 and provide the FRS operator with Conference Call Toll-Free Number: 1-800-310-7032; Conference ID: 3590626. Members of the public are invited to submit written comments; the comments must be received in the regional office by Thursday, July 26, 2018. Written comments may be mailed to the Rocky Mountain Regional Office, U.S. Commission on Civil Rights, 1961 Stout Street, Suite 13-201, Denver, CO 80294, faxed to (303) 866-1050, or emailed to Evelyn Bohor at
Records and documents discussed during the meeting will be available for public viewing as they become available at
Enforcement and Compliance, International Trade Administration, Department of Commerce.
The Department of Commerce (Commerce) finds that revocation of the antidumping duty (AD) order on certain folding gift boxes from the People's Republic of China (China) would likely lead to continuation or recurrence of dumping at the dumping margins identified in the “Final Results of Review” section of this notice.
Applicable June 7, 2018.
Keith Haynes, AD/CVD Operations, Office III, Enforcement and Compliance, International Trade Administration, U.S. Department of Commerce, 1401 Constitution Avenue NW, Washington, DC 20230; telephone: (202) 482-5139.
On February 1, 2018, Commerce published the notice of initiation of the third sunset review of the antidumping duty order
The products covered by the
Folding gift boxes included in the scope are typically decorated with a holiday motif using various processes, including printing, embossing, debossing, and foil stamping, but may also be plain white or printed with a single color. The subject merchandise includes folding gift boxes, with or without handles, whether finished or unfinished, and whether in one-piece or multi-piece configuration. One-piece gift boxes are die-cut or otherwise formed so that the top, bottom, and sides form a single, contiguous unit. Two-piece gift boxes are those with a folded bottom and a folded top as separate pieces. Folding gift boxes are generally packaged in shrink-wrap, cellophane, or other packaging materials, in single or multi-box packs for sale to the retail customer. The scope excludes folding gift boxes that have a retailer's name, logo, trademark or similar company information printed prominently on the box's top exterior (such folding gift boxes are often known as “not-for-resale” gift boxes or “give-away” gift boxes and may be provided by department and specialty stores at no charge to their retail customers). The scope of the
Imports of the subject merchandise are classified under Harmonized Tariff Schedules of the United States (HTSUS) subheadings 4819.20.0040 and 4819.50.4060. These subheadings also cover products that are outside the scope of the
All issues raised in this sunset review, including the likelihood of continuation or recurrence of dumping and the magnitude of the margins likely to prevail if the
Pursuant to sections 751(c)(1) and 752(c)(1) and (3) of the Act, we determine that revocation of the
This notice also serves as the only reminder to parties subject to an administrative protective order (APO) of their responsibility concerning the return or destruction of proprietary information disclosed under APO in accordance with 19 CFR 351.305. Timely notification of the return or destruction of APO materials or conversion to judicial protective order is hereby requested. Failure to comply with the regulations and terms of an APO is a violation which is subject to sanction.
We are issuing and publishing these results and notice in accordance with sections 751(c), 752(c), and 777(i)(1) of the Act and 19 CR 351.218.
Enforcement and Compliance, International Trade Administration, Department of Commerce.
Applicable June 7, 2018.
Chelsey Simonovich at 202-482-1979 (India); Tyler Weinhold at 202-482-1121 (the People's Republic of China (China)); George Ayache at 202-482-2623 (Thailand), AD/CVD Operations, Enforcement and Compliance, International Trade Administration, U.S. Department of Commerce, 1401 Constitution Avenue NW, Washington, DC 20230.
On April 25, 2018, the Department of Commerce (Commerce) initiated countervailing duty (CVD) investigations on glycine from India, China, and Thailand.
Section 703(b)(1) of the Tariff Act of 1930, as amended (the Act), requires Commerce to issue the preliminary determination in a CVD investigation within 65 days after the date on which Commerce initiated the investigation. However, if the petitioner makes a timely request for a postponement, section 703(c)(1)(A) of the Act allows Commerce to postpone making the preliminary determination until no later than 130 days after the date on which Commerce initiated the investigation. Under 19 CFR 351.205(e), a petitioner must submit a request for postponement 25 days or more before the scheduled date of the preliminary determination and must state the reason for the request. Commerce will grant the request unless it finds compelling reasons to deny the request.
On May 22, 2018, GEO Specialty Chemicals, Inc. and Chattem Chemicals, Inc. (collectively, the petitioners) submitted timely requests, pursuant to section 703(c)(1)(A) of the Act and 19 CFR 351.205(e), to postpone the preliminary determinations.
In accordance with 19 CFR 351.205(e), the petitioners have stated the reasons for requesting a postponement of the preliminary determination, and Commerce finds there are no compelling reasons to deny the requests. Therefore, in accordance with section 703(c)(1)(A) of the Act, Commerce is postponing the deadline for the preliminary determinations to no later than 130 days after the day on which the investigations were initiated,
This notice is issued and published pursuant to section 703(c)(2) of the Act and 19 CFR 351.205(f)(1).
National Marine Fisheries Service (NMFS), National Oceanic and Atmospheric Administration (NOAA), Commerce.
Notice of open public meeting.
This notice sets forth the proposed schedule and agenda of a forthcoming meeting of the Marine Fisheries Advisory Committee (MAFAC). The members will discuss and provide advice on issues outlined under
The meeting will be held June 26, 2018, from 8:30 a.m. to 12 p.m. and 2 p.m. to 5:15 p.m., and June 27, from 8:30 a.m. to 12 p.m.
The meeting will be held at the Port of Portland, 7200 NE Airport Way, Portland, OR 97218; 503-415-6000.
Heidi Lovett, MAFAC Assistant Director; 301-427-8034; email:
As required by section 10(a)(2) of the Federal Advisory Committee Act, 5 U.S.C. App. 2, notice is hereby given of a meeting of MAFAC. The MAFAC was established by the Secretary of Commerce (Secretary), and, since 1971, advises the Secretary on all living marine resource matters that are the responsibility of the Department of Commerce. The complete charter and summaries of prior meetings are located online at
This meeting time and agenda are subject to change.
The meeting is convened to hear presentations and updates and to discuss policies and guidance on the following topics: Columbia Basin Partnership Task Force efforts on the conservation and restoration of salmon and steelhead; NMFS communications and outreach in support of U.S. seafood competitiveness; outcomes of the recreational fisheries summit; and the budget outlook for FY2018 and FY2019. MAFAC will discuss various administrative and organizational matters, Federal Advisory Committee Act ethics and general law, and meetings of subcommittees and working groups may be convened.
The meeting is physically accessible to people with disabilities. Requests for sign language interpretation or other auxiliary aids should be directed to Heidi Lovett; 301-427-8034 by June 15, 2018.
National Marine Fisheries Service (NMFS), National Oceanic and Atmospheric Administration (NOAA), Commerce.
Notice of renewed charter.
Notice is hereby given of the 2-year renewed charter for the Marine Fisheries Advisory Committee (MAFAC), signed on April 12, 2018.
Heidi Lovett, Assistant Federal Program Officer, MAFAC, 301-427-8034.
As required by section 10(a)(2) of the Federal Advisory Committee Act, 5 U.S.C. App. (1982), notice is hereby given of the renewed charter for MAFAC. MAFAC was established by the Secretary of Commerce (Secretary) on February 17, 1972, to advise the Secretary on all living marine resource matters that are the responsibility of the Department of Commerce. This Committee advises and reviews the adequacy of living marine resources policies and programs to meet the needs of commercial and recreational fisheries, aquaculture, and environmental, consumer, academic, tribal, governmental, and other national interests. The Committee's charter must be renewed every 2 years from the date of the last renewal. The charter can be accessed online at
National Marine Fisheries Service (NMFS), National Oceanic and Atmospheric Administration (NOAA), Commerce.
Notice; Issuance of an Incidental Harassment Authorization.
In accordance with the regulations implementing the Marine Mammal Protection Act (MMPA) as amended, notification is hereby given that NMFS has issued an incidental harassment authorization (IHA) to Garden State Offshore Energy, LLC (GSOE), to incidentally harass, by Level B harassment only, marine mammals during marine site characterization surveys off the coast of Delaware as part of the Skipjack Wind Project in the area of the Commercial Lease of Submerged Lands for Renewable Energy Development on the Outer Continental Shelf (OCS-A 0482) and along potential submarine cable routes to a landfall location in Maryland or Delaware.
This Authorization is valid for one year from the date of issuance.
Jordan Carduner, Office of Protected Resources, NMFS, (301) 427-8401. Electronic copies of the applications and supporting documents, as well as a list of the references cited in this document, may be obtained by visiting the internet at:
Sections 101(a)(5)(A) and (D) of the MMPA (16 U.S.C. 1361
An authorization for incidental takings shall be granted if NMFS finds that the taking will have a negligible impact on the species or stock(s), will not have an unmitigable adverse impact on the availability of the species or stock(s) for subsistence uses (where relevant), and if the permissible methods of taking and requirements pertaining to the mitigation, monitoring and reporting of such takings are set forth.
NMFS has defined “negligible impact” in 50 CFR 216.103 as an impact resulting from the specified activity that cannot be reasonably expected to, and is not reasonably likely to, adversely affect the species or stock through effects on annual rates of recruitment or survival.
The MMPA states that the term “take” means to harass, hunt, capture, or kill, or attempt to harass, hunt, capture, or kill any marine mammal.
Except with respect to certain activities not pertinent here, the MMPA defines “harassment” as: Any act of pursuit, torment, or annoyance which (i) has the potential to injure a marine mammal or marine mammal stock in the wild (Level A harassment); or (ii) has the potential to disturb a marine mammal or marine mammal stock in the wild by causing disruption of behavioral patterns, including, but not limited to, migration, breathing, nursing, breeding, feeding, or sheltering (Level B harassment).
On November 22, 2017, NMFS received a request from GSOE for an IHA to take marine mammals incidental to marine site characterization surveys off the coast of Delaware in the area of the Commercial Lease of Submerged Lands for Renewable Energy Development on the Outer Continental Shelf (OCS-A 0482) (Lease Area) and along potential submarine cable routes to a landfall location in Maryland or Delaware. GSOE has designated Skipjack Offshore Energy, LLC (Skipjack), a wholly-owned indirect subsidiary of Deepwater Wind Holdings, LLC (Deepwater Wind), and an affiliate of GSOE, to perform the activities described in the IHA application. A revised application was received on March 19, 2018. NMFS deemed that request to be adequate and complete. GSOE's request is for take of 14 marine mammal species by Level B harassment. Neither GSOE nor NMFS expects serious injury or mortality to result from this activity, and the activity is expected to last no more than one year Therefore, an IHA is appropriate.
GSOE plans to conduct marine site characterization surveys, including high-resolution geophysical (HRG) and geotechnical surveys, in the Lease Area and along potential submarine cable routes to landfall locations in either the state of Maryland or Delaware. Surveys would occur from approximately May 2018 through December 2018.
The purpose of the marine site characterization surveys is to obtain a baseline assessment of seabed/sub-surface soil conditions in the Lease Area and cable route corridors to support the siting of the proposed Skipjack wind farm. Underwater sound resulting from GSOE's site characterization surveys have the potential to result in incidental take of marine mammals in the form of behavioral harassment. Geophysical surveys would be conducted for up to 183 days and geotechnical surveys would be conducted for up to 72 days. This schedule is based on 24-hour operations and includes potential down time due to inclement weather.
Geotechnical surveys would entail the use of core penetration testing, deep boring cores and vibracores. Geotechnical surveys are not expected to result in the take of marine mammals and are not analyzed further in this document. Geophysical surveys would entail the use of a multibeam depth sounder, shallow penetration sub-bottom profiler (chirp), medium penetration sub-bottom profiler (boomer and sparker or bubble gun), sidescan sonar and marine magnetometer. The deployment of geophysical survey equipment, including the equipment planned for use during GSOE's planned activity, produces sound in the marine environment that has the potential to result in harassment of marine mammals.
A detailed description of the planned survey activities, including types of survey equipment planned for use, is provided in the
NMFS published a notice of proposed IHA in the
GSOE determined the planned duration of the survey based on their
However, in recognition of the concerns raised by the commenters, we have added a mitigation requirement to the IHA that shutdown of geophysical survey equipment is required upon confirmed passive acoustic monitoring (PAM) detection of a North Atlantic right whale at night, even in the absence of visual confirmation, except in cases where the acoustic detection can be localized and the right whale can be confirmed as being beyond the 500 m exclusion zone (EZ); equipment may be re-started no sooner than 30 minutes after the last confirmed acoustic detection.
Regarding the commenters' recommendation to require a 500 m EZ for all marine mammals (except dolphins that approach the vessel) we have determined the EZs as currently required in the IHA (described in Mitigation Measures, below) are sufficient to ensure the least practicable adverse impact on species or stocks and their habitat. The EZs would prevent all potential instances of marine mammal injury (though in this instance, injury would not be an expected outcome even in the absence of mitigation due to very small predicted isopleths corresponding to the Level A harassment threshold (Table 5) and would further prevent some instances of behavioral harassment, as well as limiting the intensity and/or duration of behavioral harassment that does occur. As NMFS has determined the EZs currently required in the IHA to be sufficiently protective, we do not think expanded EZs, beyond what is required in the IHA, are warranted. With respect to EZs for sea turtles, we do not have the statutory authority under the MMPA to require mitigation measures specific to sea turtles.
Sections 3 and 4 of GSOE's IHA application summarize available information regarding status and trends, distribution and habitat preferences, and behavior and life history, of the potentially affected species. Additional information regarding population trends and threats may be found in NMFS' Stock Assessment Reports (SAR;
Table 1 lists all species with expected potential for occurrence in the survey area and with the potential to be taken as a result of the survey and summarizes information related to the population or stock, including regulatory status under the MMPA and ESA and potential biological removal (PBR), where known. For taxonomy, we follow Committee on Taxonomy (2017). PBR is defined by the MMPA as the maximum number of animals, not including natural mortalities, that may be removed from a marine mammal stock while allowing that stock to reach or maintain its optimum sustainable population (as described in NMFS' SARs). While no mortality is anticipated or authorized here, PBR is included here as a gross indicator of the status of the species and other threats.
Marine mammal abundance estimates presented in this document represent the total number of individuals that make up a given stock or the total number estimated within a particular study or survey area. NMFS' stock abundance estimates for most species represent the total estimate of individuals within the geographic area, if known, that comprises that stock. For some species, this geographic area may extend beyond U.S. waters. All managed stocks in this region are assessed in NMFS' U.S. 2017 draft SARs (
Four marine mammal species that are listed under the Endangered Species Act (ESA) may be present in the survey area and are included in the take request: North Atlantic right whale, fin whale, sei whale and sperm whale.
Though other marine mammal species are known to occur in the Northwest Atlantic Ocean, the temporal and/or spatial occurrence of several of these species is such that take of these species is not expected to occur, and they are therefore not discussed further beyond the explanation provided here. Take of these species is not anticipated either because they have very low densities in the project area (
For the majority of species potentially present in the specific geographic region, NMFS has designated only a single generic stock (
A detailed description of the species likely to be affected by GSOE's survey, including brief introductions to the species and relevant stocks as well as available information regarding population trends and threats, and information regarding local occurrence, were provided in the
Information concerning marine mammal hearing, including marine mammal functional hearing groups, was provided in the
The effects of underwater noise from GSOE's survey activities have the potential to result in behavioral harassment of marine mammals in the vicinity of the survey area. The
This section provides an estimate of the number of incidental takes authorized through this IHA, which will inform both NMFS' consideration of “small numbers” and the negligible impact determination.
Harassment is the only type of take expected to result from these activities. Except with respect to certain activities not pertinent here, the MMPA defines “harassment” as any act of pursuit, torment, or annoyance which (i) has the potential to injure a marine mammal or marine mammal stock in the wild (Level A harassment); or (ii) has the potential to disturb a marine mammal or marine mammal stock in the wild by causing disruption of behavioral patterns, including, but not limited to, migration, breathing, nursing, breeding, feeding, or sheltering (Level B harassment).
Authorized takes are by Level B harassment, as use of the survey equipment has the potential to result in disruption of behavioral patterns for individual marine mammals. NMFS has determined take by Level A harassment is not an expected outcome of the activity and thus we do not authorize the take of any marine mammals by Level A harassment. This is discussed in greater detail below. As described previously, no mortality or serious injury is anticipated or authorized for this activity. Below we describe how the take is estimated for this project.
Described in the most basic way, we estimate take by considering: (1) Acoustic thresholds above which NMFS believes the best available science indicates marine mammals will be behaviorally harassed or incur some degree of permanent hearing impairment; (2) the area or volume of water that will be ensonified above these levels in a day; (3) the density or occurrence of marine mammals within these ensonified areas; and (4) and the number of days of activities. Below, we describe these components in more detail and present the take estimate.
NMFS uses acoustic thresholds that identify the received level of underwater sound above which exposed marine mammals would be reasonably expected to be behaviorally harassed (equated to Level B harassment) or to incur PTS of some degree (equated to Level A harassment).
These thresholds were developed by compiling and synthesizing the best available science and soliciting input multiple times from both the public and peer reviewers to inform the final product, and are provided in Table 2 below. The references, analysis, and methodology used in the development of the thresholds are described in NMFS 2016 Technical Guidance, which may be accessed at:
*Dual metric acoustic thresholds for impulsive sounds: Use whichever results in the largest isopleth for calculating PTS onset. If a non-impulsive sound has the potential of exceeding the peak sound pressure level thresholds associated with impulsive sounds, these thresholds should also be considered.
Peak sound pressure (Lpk) has a reference value of 1 μPa, and cumulative sound exposure level (LE) has a reference value of 1μPa2s. In this Table, thresholds are abbreviated to reflect American National Standards Institute standards (ANSI 2013). However, peak sound pressure is defined by ANSI as incorporating frequency weighting, which is not the intent for this Technical Guidance. Hence, the subscript “flat” is being included to indicate peak sound pressure should be flat weighted or unweighted within the generalized hearing range. The subscript associated with cumulative sound exposure level thresholds indicates the designated marine mammal auditory weighting function (LF, MF, and HF cetaceans, and PW and OW pinnipeds) and that the recommended accumulation period is 24 hours. The cumulative sound exposure level thresholds could be exceeded in a multitude of ways (
Here, we describe operational and environmental parameters of the activity that will feed into estimating the area ensonified above the acoustic thresholds.
The survey would entail the use of HRG survey equipment. The distance to the isopleth corresponding to the threshold for Level B harassment was calculated for all HRG survey equipment with the potential to result in harassment of marine mammals using the spherical transmission loss (TL) equation: TL=20log
Predicted distances to Level A harassment isopleths, which vary based on marine mammal functional hearing groups (Table 2), were also calculated. The updated acoustic thresholds for impulsive sounds (such as HRG survey equipment) contained in the Technical Guidance (NMFS, 2016) were presented as dual metric acoustic thresholds using both SEL
Modeling of distances to isopleths corresponding to Level A harassment was performed for all types of HRG equipment planned for use with the potential to result in harassment of marine mammals. Of the HRG equipment types modeled, the AA Dura Spark resulted in the largest distances to isopleths corresponding to Level A harassment for all marine mammal functional hearing groups; therefore, to be conservative, the isopleths modeled for the AA Dura Spark were used to estimate potential Level A take. Based on a conservative assumption that the AA Dura Spark would be operated at 1,000 joules during the survey, a peak source level of 223 dB re 1μPa was used for modeling Level A harassment isopleths based on peak pressure (Crocker & Fratantonio, 2016). Inputs to the NMFS optional User Spreadsheet for the AA Dura Spark are shown in Table 4. Modeled distances to isopleths corresponding to Level A harassment thresholds for the AA Dura Spark are shown in Table 5 (modeled distances to Level A harassment isopleths for all other types of HRG equipment planned for use are shown in Table 6 of the IHA application). As described above, NMFS considers onset of PTS (Level A harassment) to have occurred when either one of the two metrics is exceeded (
Due to the small estimated distances to Level A harassment thresholds for all marine mammal functional hearing groups, based on both SEL
We note that because of some of the assumptions included in the methods used, isopleths produced may be overestimates to some degree. Most of the acoustic sources planned for use in GSOE's survey (including the AA Dura Spark) do not radiate sound equally in all directions but were designed instead to focus acoustic energy directly toward the sea floor. Therefore, the acoustic energy produced by these sources is not received equally in all directions around the source but is instead concentrated along some narrower plane depending on the beamwidth of the source. However, the calculated distances to isopleths do not account for this directionality of the sound source and are therefore conservative. Two types of geophysical survey equipment planned for use in the planned survey are omni-directional, however the modeled distances to isopleths corresponding to the Level B harassment threshold for these sources are smaller than that for the Dura Spark, and the Dura Spark was used to conservatively estimate take for the duration of the survey. For mobile sources, such as the planned survey, the User Spreadsheet predicts the closest distance at which a stationary animal would not incur PTS if the sound source traveled by the animal in a straight line at a constant speed.
In this section we provide the information about the presence, density, or group dynamics of marine mammals that will inform the take calculations.
The best available scientific information was considered in calculating marine mammal exposure estimates (the basis for estimating take). For cetacean species, densities calculated by Roberts
For the purposes of the take calculations, density data from Roberts
Systematic, offshore, at-sea survey data for pinnipeds are more limited than those for cetaceans. The best available information concerning pinniped densities in the survey area is the U.S. Navy's Operating Area (OPAREA) Density Estimates (NODEs) (DoN, 2007). These density models utilized vessel-based and aerial survey data collected by NMFS from 1998-2005 during broad-scale abundance studies. Modeling methodology is detailed in DoN (2007). For the purposes of the take calculations, NODEs Density Estimates (DoN, 2007) as reported for the summer and fall seasons in the “Mid Atlantic” area were used to estimate harbor seal densities. NODEs reports a density value of 0 for gray seals throughout the year in the “Mid Atlantic” area; however, the survey data used to develop the OPAREA Density Estimates for gray seal are nearly 20 years old; and, based on the best available information (Hayes
Here we describe how the information provided above is brought together to produce a quantitative take estimate.
In order to estimate the number of marine mammals predicted to be exposed to sound levels that would result in harassment, radial distances to predicted isopleths corresponding to harassment thresholds are calculated, as described above. Those distances are then used to calculate the area(s) around the HRG survey equipment predicted to be ensonified to sound levels that exceed harassment thresholds. The area estimated to be ensonified to relevant thresholds in a single day of the survey is then calculated, based on areas predicted to be ensonified around the HRG survey equipment and the estimated trackline distance traveled per day by the survey vessel. GSOE estimates a daily track line distance of
The number of marine mammals expected to be incidentally taken per day is then calculated by estimating the number of each species predicted to occur within the daily ensonified area, using estimated marine mammal densities as described above. Estimated numbers of each species taken per day are then multiplied by the number of survey days, and the product is then rounded, to generate an estimate of the total number of each species expected to be taken over the duration of the survey (Table 6).
Takes of bottlenose dolphins could be from either the Western North Atlantic Offshore or Western North Atlantic Northern Migratory Coastal stocks. For purposes of calculating takes as a percentage of population, we assume 50 percent of bottlenose dolphins taken will be from the Western North Atlantic Offshore stock and 50 percent will be from the Western North Atlantic Northern Migratory Coastal stock.
The applicant estimated a total of 4 takes by Level A harassment of harbor porpoises and 3 takes each by Level A harassment for harbor seals and gray seals would occur, in the absence of mitigation. However, as described above, due to the very small estimated distances to Level A harassment thresholds (Table 5), and in consideration of the planned mitigation measures, the likelihood of the planned survey resulting in take in the form of Level A harassment is considered so low as to be discountable; therefore, we do not authorize take of any marine mammals by Level A harassment. Take numbers are shown in Table 6.
In order to issue an IHA under section 101(a)(5)(D) of the MMPA, NMFS must set forth the permissible methods of taking pursuant to such activity, and other means of effecting the least practicable impact on such species or stock and its habitat, paying particular attention to rookeries, mating grounds, and areas of similar significance, and on the availability of such species or stock for taking for certain subsistence uses (latter not applicable for this action). NMFS regulations require applicants for incidental take authorizations to include information about the availability and feasibility (economic and technological) of equipment, methods, and manner of conducting such activity or other means of effecting the least practicable adverse impact upon the affected species or stocks and their habitat (50 CFR 216.104(a)(11)).
In evaluating how mitigation may or may not be appropriate to ensure the least practicable adverse impact on species or stocks and their habitat, as well as subsistence uses where applicable, we carefully consider two primary factors:
(1) The manner in which, and the degree to which, the successful implementation of the measure(s) is expected to reduce impacts to marine mammals, marine mammal species or stocks, and their habitat. This considers the nature of the potential adverse impact being mitigated (likelihood, scope, range). It further considers the likelihood that the measure will be effective if implemented (probability of accomplishing the mitigating result if implemented as planned) the likelihood of effective implementation (probability implemented as planned); and
(2) The practicability of the measures for applicant implementation, which may consider such things as relative cost and impact on operations.
Based on the applicant's request, which includes requirements relating to the BOEM Lease stipulations associated with ESA-listed marine mammals, and specific information regarding the zones ensonified above NMFS thresholds, NMFS is requiring the following mitigation measures during the marine site characterization surveys.
Marine mammal EZs would be established around the HRG survey equipment and monitored by protected species observers (PSO) during HRG surveys, as follows:
• 500 m EZ for North Atlantic right whales;
• 200 m EZ for all other ESA-listed cetaceans (including fin whale, sei whale and sperm whale); and
• 25 m EZ for harbor porpoises.
The applicant proposed a 500 m EZ for North Atlantic right whales and 200 m EZ for all other marine mammals; however, for non-ESA-listed marine mammals, based on estimated distances to isopleths corresponding with Level A harassment thresholds (Table 5), we determined EZs for species other than those described above were not warranted. If HRG survey equipment is shut down (as described below) due to a marine mammal being observed within or approaching the relevant EZs, ramp up of survey equipment may not commence until the animal(s) has been observed exiting the relevant EZ, or until an additional time period has elapsed with no further sighting of the animal (
As per the BOEM lease, visual and acoustic monitoring of the established exclusion and monitoring zones will be performed by qualified and NMFS-approved PSOs. It will be the responsibility of the Lead PSO on duty to communicate the presence of marine mammals as well as to communicate the action(s) that are necessary to ensure mitigation and monitoring requirements are implemented as appropriate. PSOs will be equipped with binoculars and would estimate distances to marine mammals located in proximity to the vessel and/or exclusion zone using range finders. Reticulated binoculars will also be available to PSOs for use as appropriate based on conditions and visibility to support the siting and monitoring of marine species. Position data will be recorded using hand-held or vessel global positioning system (GPS) units for each sighting. Observations will take place from the highest available vantage point on the survey vessel. During surveys conducted at night, night-vision equipment with infrared light-emitting diodes spotlights and/or infrared video monitoring will be available for PSO use, and passive acoustic monitoring (described below) will be used.
Prior to initiating HRG survey activities, GSOE will implement a 30-minute pre-clearance period. During this period, the PSOs will ensure that no North Atlantic right whales are observed within 500 m of geophysical survey equipment, and that no other marine mammal species are observed within 200 m of geophysical survey equipment. Surveys may not begin until these zones have been clear of the relevant marine mammal species for 30 minutes. This pre-clearance requirement would include small delphinoids that approach the vessel (
As proposed by the applicant and required by BOEM lease stipulations, PAM will be used to support monitoring during night time operations to provide for optimal acquisition of species detections at night. The PAM system will consist of an array of hydrophones with both broadband (sampling mid-range frequencies of 2 kHz to 200 kHz) and at least one low-frequency hydrophone (sampling range frequencies of 75 Hz to 30 kHz). The PAM operator(s) will monitor acoustic signals in real time both aurally (using headphones) and visually (via sound analysis software). PAM operators will communicate nighttime detections to the lead PSO on duty who will ensure the implementation of the appropriate mitigation measure.
Shutdown of geophysical survey equipment is required upon confirmed PAM detection of a North Atlantic right whale at night, even in the absence of
As proposed by the applicant, where technically feasible, a ramp-up procedure will be used for geophysical survey equipment capable of adjusting energy levels at the start or re-start of survey activities. The ramp-up procedure will be used at the beginning of HRG survey activities in order to provide additional protection to marine mammals near the survey area by allowing them to detect the presence of the survey and vacate the area prior to the commencement of survey equipment use at full energy. Ramp-up of the survey equipment will not begin until the relevant EZs have been cleared by the PSOs, as described above. Systems will be initiated at their lowest power output and will be incrementally increased to full power. If any marine mammals are detected within the EZ prior to or during the ramp-up, HRG equipment will be shut down (as described below).
If a marine mammal is observed within or approaching the relevant EZ (as described above) an immediate shutdown of the survey equipment is required. Subsequent restart of the survey equipment may only occur after the animal(s) has either been observed exiting the relevant EZ or until an additional time period has elapsed with no further sighting of the animal (
In addition, shutdown of geophysical survey equipment is required upon confirmed PAM detection of a North Atlantic right whale at night, even in the absence of visual confirmation, except in cases where the acoustic detection can be localized and the right whale can be confirmed as being beyond the 500 m EZ; equipment may be re-started no sooner than 30 minutes after the last confirmed acoustic detection.
As required in the BOEM lease, if the HRG equipment shuts down for reasons other than mitigation (
If a species for which authorization has not been granted, or, a species for which authorization has been granted but the authorized number of takes have been met, approaches or is observed within an EZ or within the watch zone, shutdown will occur.
Vessel strike avoidance measures will include, but are not limited to, the following, as required in the BOEM lease, except under circumstances when complying with these requirements would put the safety of the vessel or crew at risk:
• All vessel operators and crew will maintain vigilant watch for cetaceans and pinnipeds, and slow down or stop their vessel to avoid striking these protected species;
• All survey vessels greater than or equal to 65 ft (19.8 m) in overall length will comply with 10 knot (18.5 km/hr) or less speed restriction in any SMAper the NOAA ship strike reduction rule (73 FR 60173; October 10, 2008);
• All vessel operators will reduce vessel speed to 10 knots (18.5 km/hr) or less when any large whale, any mother/calf pairs, pods, or large assemblages of non-delphinoid cetaceans are observed near (within 100 m (330 ft)) an underway vessel;
• All survey vessels will maintain a separation distance of 500 m (1640 ft) or greater from any sighted North Atlantic right whale;
• If underway, vessels must steer a course away from any sighted North Atlantic right whale at 10 knots (18.5 km/hr) or less until the 500 m (1640 ft) minimum separation distance has been established. If a North Atlantic right whale is sighted in a vessel's path, or within 500 m (330 ft) to an underway vessel, the underway vessel must reduce speed and shift the engine to neutral. Engines will not be engaged until the North Atlantic right whale has moved outside of the vessel's path and beyond 500 m. If stationary, the vessel must not engage engines until the North Atlantic right whale has moved beyond 500 m;
• All vessels will maintain a separation distance of 100 m (330 ft) or greater from any sighted non-delphinoid cetacean. If sighted, the vessel underway must reduce speed and shift the engine to neutral, and must not engage the engines until the non-delphinoid cetacean has moved outside of the vessel's path and beyond 100 m. If a survey vessel is stationary, the vessel will not engage engines until the non-delphinoid cetacean has moved out of the vessel's path and beyond 100 m;
• All vessels will maintain a separation distance of 50 m (164 ft) or greater from any sighted delphinoid cetacean. Any vessel underway remain parallel to a sighted delphinoid cetacean's course whenever possible, and avoid excessive speed or abrupt changes in direction. Any vessel underway reduces vessel speed to 10 knots (18.5 km/hr) or less when pods (including mother/calf pairs) or large assemblages of delphinoid cetaceans are observed. Vessels may not adjust course and speed until the delphinoid cetaceans have moved beyond 50 m and/or the abeam of the underway vessel;
• All vessels will maintain a separation distance of 50 m (164 ft) or greater from any sighted pinniped; and
• All vessels underway will not divert or alter course in order to approach any whale, delphinoid cetacean, or pinniped. Any vessel underway will avoid excessive speed or abrupt changes in direction to avoid injury to the sighted cetacean or pinniped.
GSOE will ensure that vessel operators and crew maintain a vigilant watch for cetaceans and pinnipeds by slowing down or stopping the vessel to avoid striking marine mammals. Project-specific training will be conducted for all vessel crew prior to the start of the site characterization survey activities. Confirmation of the training and understanding of the requirements will be documented on a training course log sheet. Signing the log sheet will certify that the crew members understand and will comply with the necessary requirements throughout the survey activities.
As described above, the northern section of the survey area partially overlaps with a portion of one North Atlantic right whale SMA which occurs
The mitigation measures are designed to avoid the already low potential for injury in addition to some Level B harassment, and to minimize the potential for vessel strikes. There are no known marine mammal feeding areas, rookeries, or mating grounds in the survey area that would otherwise potentially warrant increased mitigation measures for marine mammals or their habitat (or both). The survey would occur in an area that has been identified as a biologically important area for migration for North Atlantic right whales. However, given the small spatial extent of the survey area relative to the substantially larger spatial extent of the right whale migratory area, and the relatively limited temporal overlap of the survey with the months that the migratory area is considered biologically important (March, April, November and December), the survey is not expected to appreciably reduce migratory habitat nor to negatively impact the migration of North Atlantic right whales. Thus additional mitigation to address the survey's occurrence in North Atlantic right whale migratory habitat is not warranted. Further, we believe the mitigation measures are practicable for the applicant to implement.
Based on our evaluation of the applicant's measures, NMFS has determined that the mitigation measures provide the means of effecting the least practicable impact on the affected species or stocks and their habitat, paying particular attention to rookeries, mating grounds, and areas of similar significance.
In order to issue an IHA for an activity, section 101(a)(5)(D) of the MMPA states that NMFS must set forth, requirements pertaining to the monitoring and reporting of such taking. The MMPA implementing regulations at 50 CFR 216.104 (a)(13) indicate that requests for authorizations must include the suggested means of accomplishing the necessary monitoring and reporting that will result in increased knowledge of the species and of the level of taking or impacts on populations of marine mammals that are expected to be present in the action area. Effective reporting is critical both to compliance as well as ensuring that the most value is obtained from the required monitoring.
Monitoring and reporting requirements prescribed by NMFS should contribute to improved understanding of one or more of the following:
• Occurrence of marine mammal species or stocks in the area in which take is anticipated (
• Nature, scope, or context of likely marine mammal exposure to potential stressors/impacts (individual or cumulative, acute or chronic), through better understanding of: (1) Action or environment (
• Individual marine mammal responses (behavioral or physiological) to acoustic stressors (acute, chronic, or cumulative), other stressors, or cumulative impacts from multiple stressors;
• How anticipated responses to stressors impact either: (1) Long-term fitness and survival of individual marine mammals; or (2) populations, species, or stocks;
• Effects on marine mammal habitat (
• Mitigation and monitoring effectiveness.
As described above, visual monitoring of the EZs and monitoring zone will be performed by qualified and NMFS-approved PSOs. Per the applicant's proposal, PSO qualifications will include completion of a PSO training course and documented field experience conducting similar surveys. As proposed by the applicant and required by BOEM, an observer team comprising a minimum of four NMFS-approved PSOs and a minimum of two certified PAM operator(s), operating in shifts, will be employed by GSOE during the planned surveys. PSOs and PAM operators would work in shifts such that no one monitor will work more than 4 consecutive hours without a 2-hour break or longer than 12 hours during any 24-hour period. During daylight hours the PSOs will rotate in shifts of one on and three off, while during nighttime operations PSOs will work in pairs. The PAM operators will also be on call as necessary during daytime operations should visual observations become impaired. Each PSO will monitor 360 degrees of the field of vision.
Also as described above, PSOs will be equipped with binoculars and have the ability to estimate distances to marine mammals located in proximity to the vessel and/or exclusion zone using range finders. Reticulated binoculars will also be available to PSOs for use as appropriate based on conditions and visibility to support the siting and monitoring of marine species. During night operations, PAM and night-vision equipment with infrared light-emitting diode spotlights and/or infrared video monitoring will be used to increase the ability to detect marine mammals. Position data will be recorded using hand-held or vessel global positioning system (GPS) units for each sighting. Observations will take place from the highest available vantage point on the survey vessel. General 360-degree scanning will occur during the monitoring periods, and target scanning by the PSO will occur when alerted of a marine mammal presence.
Data on all PAM/PSO observations will be recorded, including dates, times, and locations of survey operations; time of observation, location and weather; details of marine mammal sightings (
Within 90 days after completion of survey activities, a final technical report will be provided to NMFS that fully documents the methods and monitoring protocols, summarizes the data recorded during monitoring, summarizes the number of marine mammals estimated to have been taken during survey activities (by species, when known), summarizes the mitigation actions taken during surveys (including what type of mitigation and the species and number of animals that prompted the mitigation action, when known), includes an
In addition to the final technical report, GSOE will provide the reports described below as necessary during survey activities. In the unanticipated event that GSOE's survey activities lead to an injury (Level A harassment) or mortality (
Time, date, and location (latitude/longitude) of the incident;
• Name and type of vessel involved;
• Vessel's speed during and leading up to the incident;
• Description of the incident;
• Status of all sound source use in the 24 hours preceding the incident;
• Water depth;
• Environmental conditions (
• Description of all marine mammal observations in the 24 hours preceding the incident;
• Species identification or description of the animal(s) involved;
• Fate of the animal(s); and
• Photographs or video footage of the animal(s) (if equipment is available).
Activities would not resume until NMFS is able to review the circumstances of the event. NMFS would work with GSOE to minimize reoccurrence of such an event in the future. GSOE would not resume activities until notified by NMFS.
In the event that GSOE discovers an injured or dead marine mammal and determines that the cause of the injury or death is unknown and the death is relatively recent (
In the event that GSOE discovers an injured or dead marine mammal and determines that the injury or death is not associated with or related to the activities authorized in the IHA (
NMFS has defined negligible impact as an impact resulting from the specified activity that cannot be reasonably expected to, and is not reasonably likely to, adversely affect the species or stock through effects on annual rates of recruitment or survival. A negligible impact finding is based on the lack of likely adverse effects on annual rates of recruitment or survival (
To avoid repetition, our analysis applies to all the species listed in Table 6, given that NMFS expects the anticipated effects of the planned survey to be similar in nature.
NMFS does not anticipate that serious injury or mortality would occur as a result of GSOE's planned survey, even in the absence of mitigation. Thus this authorization does not authorize any serious injury or mortality. As discussed in the
We expect that all potential takes would be in the form of short-term Level B behavioral harassment in the form of temporary avoidance of the area, a reaction that is considered to be of low severity and with no lasting biological consequences (
The mitigation measures are expected to reduce the number and/or severity of takes by (1) giving animals the opportunity to move away from the sound source before HRG survey equipment reaches full energy; and (2) preventing animals from being exposed to sound levels that may otherwise result in injury. Additional vessel strike avoidance requirements will further mitigate potential impacts to marine mammals during vessel transit to and within the survey area.
NMFS concludes that exposures to marine mammal species and stocks due to GSOE's planned survey would result in only short-term (temporary and short in duration) effects to individuals exposed. Marine mammals may temporarily avoid the immediate area but are not expected to permanently abandon the area. Impacts to breeding, feeding, sheltering, resting, or migration are not expected, nor are shifts in habitat use, distribution, or foraging success. NMFS does not anticipate the marine mammal takes that would result from the planned survey would impact annual rates of recruitment or survival.
In summary and as described above, the following factors primarily support our determination that the impacts resulting from this activity are not expected to adversely affect the species or stock through effects on annual rates of recruitment or survival:
• No mortality, serious injury, or Level A harassment is anticipated or authorized;
• The anticipated impacts of the activity on marine mammals would be temporary behavioral changes due to avoidance of the area around the survey vessel;
• The availability of alternate areas of similar habitat value for marine mammals to temporarily vacate the survey area during the planned survey to avoid exposure to sounds from the activity;
• The project area does not contain areas of significance for feeding, mating or calving;
• Effects on species that serve as prey species for marine mammals from the survey are not expected;
• The mitigation measures, including visual and acoustic monitoring, exclusion zones, and shutdown measures, are expected to minimize potential impacts to marine mammals.
Based on the analysis contained herein of the likely effects of the specified activity on marine mammals and their habitat and taking into consideration the implementation of the monitoring and mitigation measures, NMFS finds that the total marine mammal take from the activity will have a negligible impact on all affected marine mammal species or stocks.
As noted above, only small numbers of incidental take may be authorized under section 101(a)(5)(D) of the MMPA for specified activities other than military readiness activities. The MMPA does not define small numbers and so, in practice, where estimated numbers are available, NMFS compares the number of individuals taken to the most appropriate estimation of abundance of the relevant species or stock in our determination of whether an authorization is limited to small numbers of marine mammals. Additionally, other qualitative factors may be considered in the analysis, such as the temporal or spatial scale of the activities.
The numbers of marine mammals that we authorize to be taken, for all species and stocks, would be considered small relative to the relevant stocks or populations (less than 17 percent for the Western North Atlantic Northern Migratory Coastal stock of bottlenose dolphins, and less than 5 percent for all other species and stocks) (Table 6). Bottlenose dolphins taken by the survey could originate from either the Western North Atlantic Offshore or Western North Atlantic Northern Migratory Coastal stocks, based on water depths and distances to shore in the survey area. For purposes of calculating takes as a percentage of population we assume 50 percent of bottlenose dolphins taken will originate from the Western North Atlantic Offshore stock and 50 percent will originate from the Western North Atlantic Northern Migratory Coastal stock. Based on the analysis contained herein of the activity (including the mitigation and monitoring measures) and the anticipated take of marine mammals, NMFS finds that small numbers of marine mammals will be taken relative to the population size of the affected species or stocks.
There are no relevant subsistence uses of the affected marine mammal stocks or species implicated by this action. Therefore, NMFS has determined that the total taking of affected species or stocks would not have an unmitigable adverse impact on the availability of such species or stocks for taking for subsistence purposes.
Section 7(a)(2) of the Endangered Species Act of 1973 (16 U.S.C. 1531
The NMFS Office of Protected Resources Permits and Conservation Division is authorizing the incidental take of four species of marine mammals which are listed under the ESA: The North Atlantic right, fin, sei and sperm whale. Under Section 7 of the ESA, we requested initiation of consultation with the NMFS Greater Atlantic Regional Fisheries Office (GARFO) on March 19, 2018, for the issuance of this IHA. In May, 2018, NMFS GARFO determined our issuance of the IHA to GSOE was not likely to adversely affect the North Atlantic right, fin, sei and sperm whale or the critical habitat of any ESA-listed species.
To comply with the National Environmental Policy Act of 1969 (NEPA; 42 U.S.C. 4321
Accordingly, NMFS prepared an Environmental Assessment (EA) and analyzed the potential impacts to marine mammals that would result from the project, as well as from a similar project proposed by Deepwater Wind New England LLC off the coasts of Rhode Island and Massachusetts. A Finding of No Significant Impact (FONSI) was signed on May 15, 2018. A copy of the EA and FONSI is available on the internet at:
NMFS has issued an IHA to GSOE for conducting marine site characterization surveys offshore of Delaware and along potential submarine cable routes for a period of one year, provided the previously mentioned mitigation, monitoring, and reporting requirements are incorporated.
National Marine Fisheries Service (NMFS), National Oceanic and Atmospheric Administration (NOAA), Commerce.
Notice of public meetings.
The Pacific Fishery Management Council's (Pacific Council) Salmon Technical Team (STT) will hold a series of meetings to initiate the development of salmon rebuilding plans for Klamath River fall Chinook, Sacramento River fall Chinook, Strait of Juan de Fuca natural coho, Queets River natural coho, and Snohomish River natural coho. These meetings are open to the public.
The meetings will be held June 20, 2018 through June 28, 2018. See
The STT meetings for Klamath River fall Chinook and Sacramento River fall Chinook will be held in the Siskiyou Room at the Red Lion Hotel, 1830 Hilltop Drive, Redding, CA 96002; telephone: (530) 221-8700.
The STT meeting for Strait of Juan de Fuca natural coho will be held in Room 261 at the National Oceanic and Atmospheric Administration West Coast Region Office, 510 Desmond Drive SE, Lacy, WA 98503; telephone: (360) 753-9530. Please check-in at the U.S. Fish and Wildlife's reception desk for security clearance.
The STT meetings for Queets River natural coho and Snohomish River natural coho will be held in the large conference room at the Northwest Indian Fisheries Commission, 6730 Martin Way East, Olympia, WA 98516; telephone: (360) 438-1180.
Ms. Robin Ehlke, Pacific Council; telephone: (503) 820-2410.
The STT meeting for Klamath River fall Chinook will be held Wednesday, June 20, 2018, from 10 a.m. to 5 p.m., or until business for the day has been completed.
The STT meeting for Sacramento River fall Chinook will be held Thursday, June 21, 2018, from 10 a.m. to 5 p.m., or until business for the day has been completed.
The STT meeting for Strait of Juan de Fuca natural coho will be held Tuesday, June 26, 2018, from 10 a.m. to 5 p.m., or until business for the day has been completed.
The STT meeting for Queets River natural coho will be held Wednesday, June 27, 2018, from 10 a.m. to 5 p.m., or until business for the day has been completed.
The STT meeting for Snohomish River natural coho will be held Thursday, June 28, 2018, from 10 a.m. to 5 p.m., or until business for the day has been completed.
Three natural coho stocks (Queets coho, Strait of Juan de Fuca coho, and Snohomish coho) and two Chinook stocks (Sacramento River fall Chinook and Klamath River fall Chinook) were found to meet the criteria for being classified as overfished in the PFMC Review of 2017 Ocean Salmon Fisheries. Under the tenets of the Salmon Fishery Management Plan (FMP), the STT is required to develop a salmon rebuilding plan for each of these stocks and propose them to the Council within one year.
The STT will meet with tribal, state, and other management entities who will work with the STT to provide data and expertise on pertinent topics to be included in each rebuilding plan, consistent with the FMP. Discussions may include, but are not limited to, work flow, document structure, and timeline. One meeting will occur for each of the five stocks; additional meetings will be scheduled as needed. These work sessions are open to the public.
Although non-emergency issues not contained in the meeting agenda may be discussed, those issues may not be the subject of formal action during this meeting. Action will be restricted to those issues specifically listed in this document and any issues arising after publication of this document 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 intent to take final action to address the emergency.
The meetings are physically accessible to people with disabilities. Requests for sign language interpretation or other auxiliary aids should be directed to Mr. Kris Kleinschmidt at
National Marine Fisheries Service (NMFS), National Oceanic and Atmospheric Administration (NOAA), Commerce.
Notice of public workshops.
Free Atlantic Shark Identification Workshops and Safe Handling, Release, and Identification Workshops will be held in July, August, and September of 2018. Certain fishermen and shark dealers are required to attend a workshop to meet regulatory requirements and to maintain valid permits. Specifically, the Atlantic Shark Identification Workshop is mandatory for all federally permitted Atlantic shark dealers. The Safe Handling, Release, and Identification Workshop is mandatory for vessel owners and operators who use bottom longline, pelagic longline, or gillnet gear, and who have also been issued shark or swordfish limited access permits. Additional free workshops will be conducted during 2018 and will be announced in a future notice.
The Atlantic Shark Identification Workshops will be held on July 26, August 23, and September 20, 2018. The Safe Handling, Release, and
The Atlantic Shark Identification Workshops will be held in Wilmington, NC; Ronkonkoma, NY; and Panama City Beach, FL. The Safe Handling, Release, and Identification Workshops will be held in Port St. Lucie, FL; Ocean City, MD; Ronkonkoma, NY; Galveston, TX; Panama City, FL; and Warwick, RI. See
Rick Pearson by phone: (727) 824-5399.
The workshop schedules, registration information, and a list of frequently asked questions regarding the Atlantic Shark ID and Safe Handling, Release, and ID workshops are posted on the internet at:
Since January 1, 2008, Atlantic shark dealers have been prohibited from receiving, purchasing, trading, or bartering for Atlantic sharks unless a valid Atlantic Shark Identification Workshop certificate is on the premises of each business listed under the shark dealer permit that first receives Atlantic sharks (71 FR 58057; October 2, 2006). Dealers who attend and successfully complete a workshop are issued a certificate for each place of business that is permitted to receive sharks. These certificate(s) are valid for 3 years. Thus, certificates that were initially issued in 2015 will be expiring in 2018. Approximately 145 free Atlantic Shark Identification Workshops have been conducted since January 2008.
Currently, permitted dealers may send a proxy to an Atlantic Shark Identification Workshop. However, if a dealer opts to send a proxy, the dealer must designate a proxy for each place of business covered by the dealer's permit which first receives Atlantic sharks. Only one certificate will be issued to each proxy. A proxy must be a person who is currently employed by a place of business covered by the dealer's permit; is a primary participant in the identification, weighing, and/or first receipt of fish as they are offloaded from a vessel; and who fills out dealer reports. Atlantic shark dealers are prohibited from renewing a Federal shark dealer permit unless a valid Atlantic Shark Identification Workshop certificate for each business location that first receives Atlantic sharks has been submitted with the permit renewal application. Additionally, trucks or other conveyances that are extensions of a dealer's place of business must possess a copy of a valid dealer or proxy Atlantic Shark Identification Workshop certificate.
1. July 26, 2018, 12 p.m.-4 p.m., Hampton Inn, 124 Old Eastwood Road, Wilmington, NC 28403.
2. August 23, 2018, 12 p.m.-4 p.m., Hilton Garden Inn, 3485 Veterans Memorial Highway, Ronkonkoma, NY 11779.
3. September 20, 2018, 12 p.m.-4 p.m., Hampton Inn, 13505 Panama City Beach Parkway, Panama City Beach, FL 32407.
To register for a scheduled Atlantic Shark Identification Workshop, please contact Eric Sander at
To ensure that workshop certificates are linked to the correct permits, participants will need to bring the following specific items to the workshop:
• Atlantic shark dealer permit holders must bring proof that the attendee is an owner or agent of the business (such as articles of incorporation), a copy of the applicable permit, and proof of identification.
• Atlantic shark dealer proxies must bring documentation from the permitted dealer acknowledging that the proxy is attending the workshop on behalf of the permitted Atlantic shark dealer for a specific business location, a copy of the appropriate valid permit, and proof of identification.
The Atlantic Shark Identification Workshops are designed to reduce the number of unknown and improperly identified sharks reported in the dealer reporting form and increase the accuracy of species-specific dealer-reported information. Reducing the number of unknown and improperly identified sharks will improve quota monitoring and the data used in stock assessments. These workshops will train shark dealer permit holders or their proxies to properly identify Atlantic shark carcasses.
Since January 1, 2007, shark limited-access and swordfish limited-access permit holders who fish with longline or gillnet gear have been required to submit a copy of their Safe Handling, Release, and Identification Workshop certificate in order to renew either permit (71 FR 58057; October 2, 2006). These certificate(s) are valid for 3 years. Certificates issued in 2015 will be expiring in 2018. As such, vessel owners who have not already attended a workshop and received a NMFS certificate, or vessel owners whose certificate(s) will expire prior to the next permit renewal, must attend a workshop to fish with, or renew, their swordfish and shark limited-access permits. Additionally, new shark and swordfish limited-access permit applicants who intend to fish with longline or gillnet gear must attend a Safe Handling, Release, and Identification Workshop and submit a copy of their workshop certificate before either of the permits will be issued. Approximately 280 free Safe Handling, Release, and Identification Workshops have been conducted since 2006.
In addition to certifying vessel owners, at least one operator on board vessels issued a limited-access swordfish or shark permit that uses longline or gillnet gear is required to attend a Safe Handling, Release, and Identification Workshop and receive a certificate. Vessels that have been issued a limited-access swordfish or shark permit and that use longline or gillnet gear may not fish unless both the vessel owner and operator have valid workshop certificates onboard at all times. Vessel operators who have not already attended a workshop and received a NMFS certificate, or vessel operators whose certificate(s) will expire prior to their next fishing trip, must attend a workshop to operate a vessel with swordfish and shark limited-access permits that uses longline or gillnet gear.
1. July 3, 2018, 9 a.m.-5 p.m., Holiday Inn, 10120 South US Highway 1, Port St Lucie, FL 34952.
2. July 23, 2018, 9 a.m.-5 p.m., Marriott Courtyard, 2 15th Street, Ocean City, MD 21842.
3. August 14, 2018, 9 a.m.-5 p.m., Marriott Courtyard, 5000 Express Drive South, Ronkonkoma, NY 11779.
4. August 21, 2018, 9 a.m.-5 p.m., DoubleTree Hotel, 1702 Seawall Boulevard, Galveston, TX 77550.
5. September 5, 2018, 9 a.m.-5 p.m., Hilton Garden Inn, 1101 US Highway 231, Panama City, FL 32405.
6. September 19, 2018, 9 a.m.-5 p.m., Hilton Garden Inn, 1 Thurber Street, Warwick, RI 02886.
To register for a scheduled Safe Handling, Release, and Identification Workshop, please contact Angler Conservation Education at (386) 682-0158. Pre-registration is highly recommended, but not required.
To ensure that workshop certificates are linked to the correct permits, participants will need to bring the following specific items with them to the workshop:
• Individual vessel owners must bring a copy of the appropriate swordfish and/or shark permit(s), a copy of the vessel registration or documentation, and proof of identification.
• Representatives of a business-owned or co-owned vessel must bring proof that the individual is an agent of the business (such as articles of incorporation), a copy of the applicable swordfish and/or shark permit(s), and proof of identification.
• Vessel operators must bring proof of identification.
The Safe Handling, Release, and Identification Workshops are designed to teach longline and gillnet fishermen the required techniques for the safe handling and release of entangled and/or hooked protected species, such as sea turtles, marine mammals, and smalltooth sawfish, and prohibited sharks. In an effort to improve reporting, the proper identification of protected species and prohibited sharks will also be taught at these workshops. Additionally, individuals attending these workshops will gain a better understanding of the requirements for participating in these fisheries. The overall goal of these workshops is to provide participants with the skills needed to reduce the mortality of protected species and prohibited sharks, which may prevent additional regulations on these fisheries in the future.
16 U.S.C. 1801
National Telecommunications and Information Administration, U.S. Department of Commerce.
Notice of Open Meeting.
The National Telecommunications and Information Administration (NTIA) will convene meetings of a multistakeholder process on promoting software component transparency. This Notice announces the first meeting, which is scheduled for July 19, 2018.
The meeting will be held on July 19, 2018, from 10:00 a.m. to 4:00 p.m., Eastern Daylight Time.
The meeting will be held at the American Institute of Architects, 1735 New York Ave. NW, Washington, DC 20006.
Allan Friedman, National Telecommunications and Information Administration, U.S. Department of Commerce, 1401 Constitution Avenue NW, Room 4725, Washington, DC 20230; telephone: (202) 482-4281; email:
Several themes emerged from these three public consultations. Many stakeholders emphasized the importance of community-led, consensus-driven, and risk-based solutions to address information security challenges, highlighting the role NTIA should play in convening multistakeholder processes. In the digital ecosystem, particular challenges were identified: Understanding and handling vulnerability information, addressing the insecurities in the growing IoT marketplace, and fostering a secure development lifecycle. NTIA has convened two multistakeholder processes to address these policy and market challenges. The first focused on how to promote collaboration around communicating vulnerability information, and the second helped vendors and consumers understand policy and market concerns related to patching vulnerabilities.
The next initiative will focus on promoting software component transparency. Stakeholders will engage in an open and transparent process to explore the benefits and any potential risks of greater transparency. They may focus on incentives and barriers to adoption of transparency practices. The scope could include policy and international components. Transparency-driven solutions need not be prescriptive or regulatory, and can accommodate an ecosystem without a one-size-fits-all approach. The goal of this initiative is to foster a market that
Most modern software is not written completely from scratch, but includes existing components, modules, and libraries from the open source and commercial software world. Modern development practices such as code reuse, and a dynamic IT marketplace with acquisitions and mergers, make it challenging to track the use of software components. The Internet of Things compounds this phenomenon, as new organizations, enterprises and innovators take on the role of software developer to add “smart” features or connectivity to their products. While the majority of libraries and components do not have known vulnerabilities, many do, and the sheer quantity of software means that some software products ship with vulnerable or out-of-date components. Many technical solutions to aid in this have already been developed by industry and the standards community.
Vendors and developers also would find software component data useful. Cataloging the inputs to a software product is recognized as an important part of a secure development life cycle.
The importance of transparency in information security is widely recognized, and the notion of transparency around components of software and connected devices is not new. Academics identified the potential value of a “software bill of materials” as far back as 1995,
Any conversation around transparency must include a discussion of the needs of the diverse set of enterprise software users. Data about the underlying code can help both the customer and the vendor. It should be incorporated into a security-mature organization's existing vulnerability management solutions, and can help foster further innovation. Having access to this data can help organizations mitigate concerns around orphaned devices and products, and lower the risks of investing in new products by increasing capabilities to deal with future security issues.
NTIA will act as the convener, but stakeholders will drive the outcomes. Stakeholders will determine how to scope and organize the work through subgroups or other means. Success of the process will be evaluated by the extent to which broader findings on software component transparency are implemented across the ecosystem.
This multistakeholder process is not a standards development process and will not supplant ongoing standards efforts or discussions. NTIA will frame the initial conversation around the policy and market considerations for greater software component transparency. NTIA encourages cross-sector participation as this will help to prevent sector-specific solutions that could fragment the marketplace. NTIA encourages discussion of approaches and considerations from diverse sectors such as the medical device community, where the applicability of a “bill of materials” has garnered increased discussion and interest.
The July 19, 2018, meeting is intended to bring stakeholders together to share the range of views on software component transparency, and to establish more concrete goals and structure of the process. The objectives of this first meeting are to: (1) Share the perspectives and concerns of both the vendor and enterprise customer communities; (2) discuss and acknowledge what is already working; (3) explore obstacles and challenges for greater transparency and better risk decisions; (4) identify promising areas of potential collaboration; (5) engage stakeholders in a discussion of logistical issues, including internal structures such as a small drafting committee or various working groups, and the location and frequency of future meetings; and (6) identify concrete goals and stakeholder work following the first meeting. These topics could include, but are in no way limited to, an inventory of existing statutory, policy, regulatory, and market efforts to increase software component transparency; identification of incentives and disincentives for market adoption of approaches for software component transparency; exploration of statutory, policy, and regulatory activities that may inhibit adoption; accessible high-level guidance for strategic decision-makers; and review of international approaches to understand statutory, policy, and regulatory environments to understand effects on market adoption.
The main objective of further meetings will be to encourage and facilitate continued discussion among stakeholders to map the range of issues, and develop a consensus view for some
More information about stakeholders' work will be available at:
The meeting is physically accessible to people with disabilities. Requests for sign language interpretation or other auxiliary aids should be directed to Allan Friedman at (202) 482-4281 or
Commodity Futures Trading Commission.
Notice.
The Commodity Futures Trading Commission (“Commission” or “CFTC”) is announcing an opportunity for public comment on the proposed collection of certain information by the agency. Under the Paperwork Reduction Act (“PRA”), Federal agencies are required to publish notice in the
Comments must be submitted on or before August 6, 2018.
You may submit comments, identified by OMB Control No. 3038-0093 by any of the following methods:
• The Agency's website, at
•
•
Please submit your comments using only one method and identify that it is for the renewal of Collection Number 3038-0093.
All comments must be submitted in English, or if not, accompanied by an English translation. Comments will be posted as received to
The Commission reserves the right, but shall have no obligation, to review, pre-screen, filter, redact, refuse or remove any or all of your submission from
Lois J. Gregory, Associate Director, Division of Market Oversight, Commodity Futures Trading Commission, (202) 418-5092; email:
Under the PRA, 44 U.S.C. 3501
With respect to the collection of information, the CFTC invites comments on:
• Whether the proposed collection of information is necessary for the proper
• The accuracy of the Commission's estimate of the burden of the proposed collection of information, including the validity of the methodology and assumptions used;
• Ways to enhance the quality, usefulness, and clarity of the information to be collected; and
• Ways to minimize the burden of 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;
• Rules 40.2, 40.3, 40.5, and 40.6
• Rule 40.10
Commodity Futures Trading Commission.
Notice; Extension of an Existing Collection.
The Commodity Futures Trading Commission (CFTC) is announcing an opportunity for public comment on the proposed extension of a collection of certain information by the agency. Under the Paperwork Reduction Act of 1995 (PRA), Federal agencies are required to publish notice in the
Comments must be submitted on or before August 6, 2018.
You may submit comments, identified by OMB Control No. 3038-0007 by any of the following methods:
•
•
•
Please submit your comments using only one method and identify that it is for the renewal of Collection Number 3038-0007.
All comments must be submitted in English, or if not, accompanied by an English translation. Comments will be posted as received to
The Commission reserves the right, but shall have no obligation, to review, pre-screen, filter, redact, refuse or remove any or all of your submission from
Commodity Futures Trading Commission, Three Lafayette Center, 1155 21st Street NW, Washington, DC 20581; Jacob Chachkin, Division of Swap Dealer and Intermediary Oversight, telephone: (202) 418-5496 and email:
Under the PRA, 44 U.S.C. 3501
With respect to the above collection of information, the CFTC invites comments on:
• Whether the proposed collection of information is necessary for the proper performance of the functions of the Commission, including whether the information will have a practical use;
• The accuracy of the Commission's estimate of the burden of the proposed collection of information, including the validity of the methodology and assumptions used;
• Ways to enhance the quality, usefulness, and clarity of the information to be collected; and
• Ways to minimize the burden of 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;
There are no capital costs or operating and maintenance costs associated with this collection.
Office of Postsecondary Education, Department of Education.
Notice.
The Department of Education is issuing a notice inviting applications for new awards for fiscal year (FY) 2018 for the Gaining Early Awareness and Readiness for Undergraduate Programs (GEAR UP) Partnership Grants, Catalog of Federal Domestic Assistance (CFDA) number 84.334A.
For the addresses for obtaining and submitting an application, please refer to our Common Instructions for Applicants to Department of Education Discretionary Grant Programs, published in the
Karmon Simms-Coates, U.S. Department of Education, 400 Maryland Avenue SW, room 278-54, Washington, DC 20202-6450. Telephone: (202) 453-7917. Email:
If you use a telecommunications device for the deaf (TDD) or a text telephone (TTY), call the Federal Relay Service (FRS), toll free, at 1-800-877-8339.
In this notice, the Department invites applications for partnership grants only. We will invite applications for State grants in another notice published in the
The four categories under this priority are:
Projects that are designed to address one or more of the following priority areas:
(a) Developing or implementing pathways to recognized postsecondary credentials (as defined in section 3(52) of the Workforce Innovation and Opportunity Act of 2014 (WIOA)) focused on career and technical skills that align with in-demand industry sectors or occupations (as defined in section 3(23) of WIOA). Students may obtain such credentials through a wide variety of education providers, such as: IHEs eligible for Federal student financial aid programs, nontraditional education providers (
(b) Providing work-based learning experiences (such as internships, apprenticeships, and fellowships) that align with in-demand industry sectors or occupations (as defined in section 3(23) of WIOA);
(c) Creating or expanding innovative paths to a recognized postsecondary credential or obtainment of job-ready skills that align with in-demand industry sectors or occupations (as defined in section 3(23) of WIOA), such as through career pathways (as defined in section 3(7) of WIOA). Such credentials may be offered to students through a wide variety of education providers, such as providers eligible for Federal student financial aid programs, nontraditional education providers, and providers of self-guided learning; or
(d) Creating or expanding opportunities for students to obtain recognized postsecondary credentials in science, technology, engineering, mathematics, or computer science (as defined in this notice).
Projects designed to improve student achievement or other educational outcomes in one or more of the following areas: Science, technology, engineering, math, or computer science (as defined in this notice). These projects may address one or more of the following priority areas:
(a) Supporting student mastery of key prerequisites (
(b) Increasing access to STEM coursework, including computer science (as defined in this notice), and hands-on learning opportunities, such as through expanded course offerings, dual-enrollment, high-quality online coursework, or other innovative delivery mechanisms;
(c) Creating or expanding partnerships between schools, LEAs, State educational agencies, businesses, not-for-profit organizations, or IHEs to give students access to internships, apprenticeships, or other work-based learning experiences in STEM fields, including computer science (as defined in this notice);
(d) Other evidence-based (as defined in 34 CFR 77.1 and in this notice) and innovative approaches to expanding access to high-quality STEM education, including computer science (as defined in this notice); or
(e) Utilizing technology for educational purposes in communities served by rural local educational agencies (as defined in this notice) or other areas identified as lacking sufficient access to such tools and resources.
Projects that are designed to address one or more of the following priority areas:
(a) Protecting free speech in order to allow for the discussion of diverse ideas or viewpoints; or
(b) Fostering knowledge of the common rights and responsibilities of American citizenship and civic participation, such as through civics education consistent with section 203(12) of WIOA.
Projects that are designed to address supporting instruction in personal financial literacy, knowledge of markets and economics, knowledge of higher education financing and repayment (
Computer science often includes computer programming or coding as a tool to create software, including applications, games, websites, and tools to manage or manipulate data; or development and management of computer hardware and the other electronics related to sharing, securing, and using digital information.
In addition to coding, the expanding field of computer science emphasizes computational thinking and interdisciplinary problem-solving to
Computer science does not include using a computer for everyday activities, such as browsing the internet; use of tools like word processing, spreadsheets, or presentation software; or using computers in the study and exploration of unrelated subjects.
(i) A randomized controlled trial employs random assignment of, for example, students, teachers, classrooms, or schools to receive the project component being evaluated (the treatment group) or not to receive the project component (the control group).
(ii) A regression discontinuity design study assigns the project component being evaluated using a measured variable (
(iii) A single-case design study uses observations of a single case (
(i) A practice guide prepared by the WWC using version 2.1 or 3.0 of the WWC Handbook reporting a “strong evidence base” or “moderate evidence base” for the corresponding practice guide recommendation;
(ii) An intervention report prepared by the WWC using version 2.1 or 3.0 of the WWC Handbook reporting a “positive effect” or “potentially positive effect” on a relevant outcome based on a “medium to large” extent of evidence, with no reporting of a “negative effect” or “potentially negative effect” on a relevant outcome; or
(iii) A single experimental study or quasi-experimental design study reviewed and reported by the WWC using version 2.1 or 3.0 of the WWC Handbook, or otherwise assessed by the Department using version 3.0 of the WWC Handbook, as appropriate, and that—
(A) Meets WWC standards with or without reservations;
(B) Includes at least one statistically significant and positive (
(C) Includes no overriding statistically significant and negative effects on relevant outcomes reported in the study or in a corresponding WWC intervention report prepared under version 2.1 or 3.0 of the WWC Handbook; and
(D) Is based on a sample from more than one site (
(i) A practice guide prepared by WWC reporting a “strong evidence base” or “moderate evidence base” for the corresponding practice guide recommendation;
(ii) An intervention report prepared by the WWC reporting a “positive effect” or “potentially positive effect” on a relevant outcome with no reporting of a “negative effect” or “potentially negative effect” on a relevant outcome; or
(iii) A single study assessed by the Department, as appropriate, that—
(A) Is an experimental study, a quasi-experimental design study, or a well-designed and well-implemented correlational study with statistical controls for selection bias (
(B) Includes at least one statistically significant and positive (
(i) A practice guide prepared by the WWC using version 2.1 or 3.0 of the WWC Handbook reporting a “strong evidence base” for the corresponding practice guide recommendation;
(ii) An intervention report prepared by the WWC using version 2.1 or 3.0 of the WWC Handbook reporting a “positive effect” on a relevant outcome based on a “medium to large” extent of evidence, with no reporting of a “negative effect” or “potentially negative effect” on a relevant outcome; or
(iii) A single experimental study reviewed and reported by the WWC using version 2.1 or 3.0 of the WWC Handbook, or otherwise assessed by the Department using version 3.0 of the WWC Handbook, as appropriate, and that—
(A) Meets WWC standards without reservations;
(B) Includes at least one statistically significant and positive (
(C) Includes no overriding statistically significant and negative effects on relevant outcomes reported in the study or in a corresponding WWC intervention report prepared under version 2.1 or 3.0 of the WWC Handbook; and
(D) Is based on a sample from more than one site (
The regulations in 34 CFR part 86 apply to IHEs only.
Contingent upon the availability of funds and the quality of applications, we may make additional awards in subsequent years from the list of unfunded applications from this competition.
The Department is not bound by any estimates in this notice.
An applicant that wishes to seek funding for a seventh project year (
1.
2. a.
Section 404C(b)(2) further provides that the Secretary may approve a partnership's request for a reduced match percentage at the time of application if the partnership demonstrates significant economic hardship that precludes the partnership from meeting the matching requirement, or if the partnership requests that contributions to the scholarship fund be matched on the basis of two non-Federal dollars for every one Federal dollar of GEAR UP funds. GEAR UP program regulations in 34 CFR 694.8(a)-(c) address the content of an applicant's request for such a reduced match, and the maximum percentage match that the Secretary may waive. In addition, the Secretary may approve a reduction in
b.
3.
In order for an eligible entity to qualify for a grant under the GEAR UP program, the eligible entity shall submit to the Secretary an application for carrying out a GEAR UP program that—
(a) Describes the activities for which assistance under this program is sought, including how the eligible entity will carry out the required activities described in section 404D(a) of the HEA;
(b) Describes, in the case of an eligible entity described in section 404A(c)(2) of the HEA that chooses to provide scholarships, or an eligible entity described in section 404A(c)(1) of the HEA, how the eligible entity will meet the requirements of section 404E of the HEA;
(c) Describes, in the case of an eligible entity described in section 404A(c)(2) of the HEA that requests a reduced match percentage under subsection (b)(2), how such reduction will assist the entity to provide the scholarships described in subsection (b)(2)(A)(ii);
(d) Provides assurances that adequate administrative and support staff will be responsible for coordinating the activities described in section 404D of the HEA;
(e) Provides assurances that activities assisted under this program will not displace an employee or eliminate a position at a school assisted under this program, including a partial displacement such as a reduction in hours, wages, or employment benefits;
(f) Describes, in the case of an eligible entity described in section 404A(c)(1) of the HEA that chooses to use a cohort approach, or an eligible entity described in section 404A(c)(2) of the HEA, how the eligible entity will define the cohorts of the students served by the eligible entity pursuant to section 404B(d) of the HEA, and how the eligible entity will serve the cohorts through grade 12, including—
(i) How vacancies in the program under this program will be filled; and
(ii) How the eligible entity will serve students attending different secondary schools;
(g) Describes how the eligible entity will coordinate programs under this program with other existing Federal, State, or local programs to avoid duplication and maximize the number of students served;
(h) Provides such additional assurances as the Secretary determines necessary to ensure compliance with the requirements of this program;
(i) Provides information about the activities that will be carried out by the eligible entity to support systemic changes from which future cohorts of students will benefit; and
(j) Describes the sources of matching funds that will enable the eligible entity to meet the matching requirement described in subsection (b).
4.
1.
2.
3.
4.
5.
Applications that do not follow the formatting recommendations will not be penalized.
We recommend the following standards:
• A “page” is 8.5″ x 11″, on one side only, with 1″ margins.
• Double-space all text in the application project narrative, and single-space titles, headings, footnotes, quotations, references, and captions.
• Use a 12-point font.
• Use an easily readable font such as Times New Roman, Courier, Courier New, or Arial.
1.
a.
(1) The Secretary considers the need for the proposed project.
(2) In determining the need for the proposed project, the Secretary considers the following factors:
(i) The magnitude or severity of the problem to be addressed by the proposed project; and
(ii) The extent to which specific gaps or weaknesses in services, infrastructure, or opportunities have been identified and will be addressed by the proposed project, including the nature and magnitude of those gaps or weaknesses.
b.
(1) The Secretary considers the quality of the project design.
(2) In determining the quality of project design, the Secretary considers the following factors:
(i) The extent to which the goals, objectives, and outcomes to be achieved by the proposed project are clearly specified and measurable;
(ii) The extent to which the project design reflects up-to-date research and the replication of effective practices; and
(iii) The extent to which the project supports systemic changes from which future cohorts of students will benefit.
(3) The extent to which the proposed project demonstrates a rationale (as defined in 34 CFR 77.1(c) and in this notice.
c.
(1) The Secretary considers the quality of the services to be provided by the proposed project.
(2) In determining the quality of project services provided by the proposed project, the Secretary considers the quality and sufficiency of strategies for ensuring equal access and treatment for eligible project participants who are members of groups that have traditionally been underrepresented based on race, color, national origin, gender, age, or disability.
(3) In addition, the Secretary considers the following factors:
(i) The extent to which the project services are likely to provide comprehensive mentoring, outreach, and supportive services to students, including the following activities: Information regarding financial aid for postsecondary education to participating students, encouraging student enrollment in rigorous and challenging curricula and coursework in order to reduce the need for remedial coursework at the postsecondary level, and improving the number of participating students who obtain a secondary school diploma and complete applications for and enroll in a program of postsecondary education; and
(ii) The extent to which the services to be provided by the proposed project involve the collaboration of appropriate partners for maximizing the effectiveness of project services.
d.
(1) The Secretary considers the quality of the personnel who will carry out the proposed project.
(2) In determining the quality of project personnel, the Secretary considers the extent to which the applicant encourages applications for employment from persons who are members of groups that have traditionally been underrepresented based on race, color, national origin, gender, age or disability.
(2) In addition, the Secretary considers the following factors:
(i) The qualifications, including relevant training and experience, of the project director or principal investigator; and
(ii) The qualifications, including relevant training and experience, of key personnel.
e.
(1) The Secretary considers the quality of the management plan for the proposed project.
(2) In determining the quality of the management plan for the proposed project, the Secretary considers the following factors:
(i) The adequacy of the management plan to achieve the objectives of the proposed project on time and within budget, including clearly defined responsibilities, timelines, and milestones for accomplishing project tasks;
(ii) The adequacy of procedures for ensuring feedback and continuous improvement in the operation of the proposed project;
(iii) The extent to which the time commitments of the project director and other key project personnel are appropriate and adequate to meet the objectives of the proposed project; and
(iv) How the applicant will ensure that a diversity of perspectives are brought to bear in the operation of the proposed project, including those of parents, teachers, the business community, a variety of disciplinary and professional fields, recipients or beneficiaries of services, or others, as appropriate.
f.
(1) The Secretary considers the quality of the evaluation to be conducted of the proposed project.
(2) In determining the quality of the project evaluation, the Secretary considers the following factors:
(i) The extent to which the methods of evaluation are thorough, feasible, and appropriate to the goals, objectives, and outcomes of the proposed project;
(ii) The extent to which the methods of evaluation include the use of objective performance measures that are clearly related to the intended outcomes of the project and will produce quantitative and qualitative data to the extent possible;
(iii) The extent to which the methods of evaluation will provide performance feedback and permit periodic assessment of progress toward achieving intended outcomes;
(iv) The extent to which the evaluation will provide guidance about effective strategies suitable for replication or testing in other settings; and
(v) The extent to which the methods of evaluation will, if well-implemented, produce promising evidence (as defined in 34 CFR 77.1(c)) about the projects effectiveness.
g.
(1) The Secretary considers the adequacy of resources for the proposed project.
(2) In determining the adequacy of resources for the proposed project, the Secretary considers the following factors:
(i) The adequacy of support, including facilities, equipment, supplies and other resources from the applicant organization or the lead applicant organization;
(ii) The relevance and demonstrated commitment of each partner in the proposed project to the implementation and success of the project;
(iii) The extent to which the costs are reasonable in relation to the number of persons to be served and to the anticipated results and benefits; and
(iv) The potential for continued support of the project after Federal funding ends, including, as appropriate, the demonstrated commitment of appropriate entities to such support.
2.
In addition, in making a competitive grant award, the Secretary requires various assurances including those applicable to Federal civil rights laws that prohibit discrimination in programs or activities receiving Federal financial assistance from the Department of Education (34 CFR 100.4, 104.5, 106.4, 108.8, and 110.23) as well as all applicable requirements of all other Federal laws, executive orders, regulations, and policies governing this program.
For this competition, a panel of non-Federal reviewers will review each application in accordance with the selection criteria in 34 CFR 75.217(d)(3) as required by 20 U.S.C. 1070-a23(d). The individual scores of the reviewers will be added and the sum divided by the number of reviewers to determine the peer review score received in the review process.
If there are insufficient funds for all applications with the same total scores, to the extent practicable the Secretary will consider the distribution of grant awards based on the geographic distribution of such grant awards and the distribution between urban and rural applicants for the GEAR UP program consistent with 20 U.S.C. 1070a-22(a)(3).
3.
4.
Please note that, if the total value of your currently active grants, cooperative agreements, and procurement contracts from the Federal Government exceeds $10,000,000, the reporting requirements in 2 CFR part 200, Appendix XII, require you to report certain integrity information to FAPIIS semiannually. Please review the requirements in 2 CFR part 200, Appendix XII, if this grant plus all the other Federal funds you receive exceed $10,000,000.
1.
If your application is not evaluated or not selected for funding, we will notify you.
2.
We reference the regulations outlining the terms and conditions of an award in the
3.
4.
(b) At the end of your project period, you must submit a final performance report, including financial information, as directed by the Secretary. If you receive a multiyear award, you must submit an annual performance report that provides the most current performance and financial expenditure information as directed by the Secretary under 34 CFR 75.118. The Secretary may also require more frequent performance reports under 34 CFR 75.720(c). For specific requirements on reporting, please go to
(c) Under 34 CFR 75.250(b), the Secretary may provide a grantee with additional funding for data collection analysis and reporting. In this case the Secretary establishes a data collection period.
5.
The effectiveness of this program depends on the rate at which program participants complete high school and enroll in and complete a postsecondary education. Under the Government Performance and Results Modernization Act, we developed the following performance measures to track progress toward achieving the program's goals:
1. The percentage of GEAR UP students who pass Pre-Algebra by the end of 8th grade.
2. The percentage of GEAR UP students who pass Algebra 1 by the end of 9th grade.
3. The percentage of GEAR UP students who take two years of mathematics beyond Algebra 1 by 12th grade.
4. The percentage of GEAR UP students who are on track for graduation at the end of each grade.
5. The percentage of GEAR UP students who are on track to apply for college as measured by completion of the SAT or ACT by the end of 11th grade.
6. The percentage of GEAR UP students who graduate from high school.
7. The percentage of GEAR UP students who complete the Free Application for Federal Student Aid.
8. The percentage of GEAR UP students and former GEAR UP students who are enrolled at an IHE.
9. The percentage of GEAR UP students who place into college-level math and English without need for remediation.
10. The percentage of current GEAR UP students and former GEAR UP students who are on track to graduate from an IHE one year after enrolling in an IHE.
In addition, to assess the efficiency of the program, we track the average cost, in Federal funds, of achieving a successful outcome, where success is defined as enrollment in a program of undergraduate instruction at an IHE of GEAR UP students immediately after high school graduation. These performance measures constitute GEAR UP's indicators of the success of the program. Accordingly, we request that applicants include these performance measures in conceptualizing the design, implementation, and evaluation of their proposed projects.
6.
In making a continuation grant, the Secretary also considers whether the grantee is operating in compliance with the assurances in its approved application, including those applicable to Federal civil rights laws that prohibit discrimination in programs or activities receiving Federal financial assistance from the Department (34 CFR 100.4, 104.5, 106.4, 108.8, and 110.23) as well as all applicable requirements of all other Federal laws, executive orders, regulations, and policies governing this program.
You may also access documents of the Department published in the
Office of Postsecondary Education, Department of Education.
Notice.
The Department of Education is issuing a notice inviting applications for new awards for fiscal year (FY) 2018 for the Gaining Early Awareness and Readiness for Undergraduate Programs (GEAR UP) State Grants, Catalog of Federal Domestic Assistance (CFDA) number 84.334S.
For the addresses for obtaining and submitting an application, please refer to our Common Instructions for Applicants to Department of Education Discretionary Grant Programs, published in the
Karmon Simms-Coates, U.S. Department of Education, 400 Maryland Avenue SW, room 278-54, Washington, DC 20202-6450. Telephone: (202) 453-7917. Email:
If you use a telecommunications device for the deaf (TDD) or a text telephone (TTY), call the Federal Relay Service (FRS), toll free, at 1-800-877-8339.
In this notice, the Department invites applications for State grants only. We will invite applications for partnership grants in another notice published in the
On March 2, 2018, the Secretary published in the
The four categories under this priority are:
Projects that are designed to address one or more of the following priority areas:
(a) Developing or implementing pathways to recognized postsecondary credentials (as defined in section 3(52) of the Workforce Innovation and Opportunity Act of 2014 (WIOA)) focused on career and technical skills that align with in-demand industry sectors or occupations (as defined in section 3(23) of WIOA). Students may obtain such credentials through a wide variety of education providers, such as: IHEs eligible for Federal student financial aid programs, nontraditional education providers (
(b) Providing work-based learning experiences (such as internships, apprenticeships, and fellowships) that align with in-demand industry sectors or occupations (as defined in section 3(23) of WIOA);
(c) Creating or expanding innovative paths to a recognized postsecondary credential or obtainment of job-ready skills that align with in-demand industry sectors or occupations (as defined in section 3(23) of WIOA), such as through career pathways (as defined in section 3(7) of WIOA). Such credentials may be offered to students through a wide variety of education providers, such as providers eligible for Federal student financial aid programs, nontraditional education providers, and providers of self-guided learning; or
(d) Creating or expanding opportunities for students to obtain recognized postsecondary credentials in science, technology, engineering, mathematics, or computer science (as defined in this notice).
Projects designed to improve student achievement or other educational outcomes in one or more of the following areas: Science, technology, engineering, math, or computer science (as defined in this notice). These projects may address one or more of the following priority areas:
(a) Supporting student mastery of key prerequisites (
(b) Increasing access to STEM coursework, including computer science (as defined in this notice), and hands-on learning opportunities, such as through expanded course offerings, dual-enrollment, high-quality online coursework, or other innovative delivery mechanisms;
(c) Creating or expanding partnerships between schools, LEAs, State educational agencies, businesses, not-for-profit organizations, or IHEs to give students access to internships, apprenticeships, or other work-based learning experiences in STEM fields, including computer science (as defined in this notice);
(d) Other evidence-based (as defined in 34 CFR 77.1 and in this notice) and innovative approaches to expanding access to high-quality STEM education, including computer science (as defined in this notice); or
(e) Utilizing technology for educational purposes in communities served by rural local educational agencies (as defined in this notice) or other areas identified as lacking sufficient access to such tools and resources.
Projects that are designed to address one or more of the following priority areas:
(a) Protecting free speech in order to allow for the discussion of diverse ideas or viewpoints; or
(b) Fostering knowledge of the common rights and responsibilities of American citizenship and civic participation, such as through civics education consistent with section 203(12) of WIOA.
Projects that are designed to address supporting instruction in personal financial literacy, knowledge of markets and economics, knowledge of higher education financing and repayment (
This priority is:
We give priority to an eligible applicant for a State GEAR UP grant that has: (a) Carried out a successful State GEAR UP grant prior to August 14, 2008, determined on the basis of data (including outcome data) submitted by the applicant as part of its annual and final performance reports from prior GEAR UP State grants administered by the applicant and the applicant's history of compliance with applicable statutory and regulatory requirements; and (b) a prior, demonstrated commitment to early intervention leading to college access through collaboration and replication of successful strategies.
Computer science often includes computer programming or coding as a tool to create software, including applications, games, websites, and tools to manage or manipulate data; or development and management of computer hardware and the other electronics related to sharing, securing, and using digital information.
In addition to coding, the expanding field of computer science emphasizes computational thinking and interdisciplinary problem-solving to equip students with the skills and abilities necessary to apply computation in our digital world.
Computer science does not include using a computer for everyday activities,
(i) A randomized controlled trial employs random assignment of, for example, students, teachers, classrooms, or schools to receive the project component being evaluated (the treatment group) or not to receive the project component (the control group).
(ii) A regression discontinuity design study assigns the project component being evaluated using a measured variable (
(iii) A single-case design study uses observations of a single case (
(i) A practice guide prepared by the WWC using version 2.1 or 3.0 of the WWC Handbook reporting a “strong evidence base” or “moderate evidence base” for the corresponding practice guide recommendation;
(ii) An intervention report prepared by the WWC using version 2.1 or 3.0 of the WWC Handbook reporting a “positive effect” or “potentially positive effect” on a relevant outcome based on a “medium to large” extent of evidence, with no reporting of a “negative effect” or “potentially negative effect” on a relevant outcome; or
(iii) A single experimental study or quasi-experimental design study reviewed and reported by the WWC using version 2.1 or 3.0 of the WWC Handbook, or otherwise assessed by the Department using version 3.0 of the WWC Handbook, as appropriate, and that—
(A) Meets WWC standards with or without reservations;
(B) Includes at least one statistically significant and positive (
(C) Includes no overriding statistically significant and negative effects on relevant outcomes reported in the study or in a corresponding WWC intervention report prepared under version 2.1 or 3.0 of the WWC Handbook; and
(D) Is based on a sample from more than one site (
(i) A practice guide prepared by WWC reporting a “strong evidence base” or “moderate evidence base” for the corresponding practice guide recommendation;
(ii) An intervention report prepared by the WWC reporting a “positive effect” or “potentially positive effect” on a relevant outcome with no reporting of a “negative effect” or “potentially negative effect” on a relevant outcome; or
(iii) A single study assessed by the Department, as appropriate, that—
(A) Is an experimental study, a quasi-experimental design study, or a well-designed and well-implemented correlational study with statistical controls for selection bias (
(B) Includes at least one statistically significant and positive (
(i) A practice guide prepared by the WWC using version 2.1 or 3.0 of the WWC Handbook reporting a “strong evidence base” for the corresponding practice guide recommendation;
(ii) An intervention report prepared by the WWC using version 2.1 or 3.0 of the WWC Handbook reporting a “positive effect” on a relevant outcome based on a “medium to large” extent of evidence, with no reporting of a “negative effect” or “potentially negative effect” on a relevant outcome; or
(iii) A single experimental study reviewed and reported by the WWC using version 2.1 or 3.0 of the WWC Handbook, or otherwise assessed by the Department using version 3.0 of the WWC Handbook, as appropriate, and that—
(A) Meets WWC standards without reservations;
(B) Includes at least one statistically significant and positive (
(C) Includes no overriding statistically significant and negative effects on relevant outcomes reported in the study or in a corresponding WWC intervention report prepared under version 2.1 or 3.0 of the WWC Handbook; and
(D) Is based on a sample from more than one site (
Contingent upon the availability of funds and the quality of applications, we may make additional awards in subsequent years from the list of unfunded applications from this competition.
The Department is not bound by any estimates in this notice.
An applicant that wishes to seek funding for a seventh project year (
1.
2.a.
b.
3.
In order for an eligible entity to qualify for a grant under the GEAR UP program, the eligible entity shall submit
(a) Describes the activities for which assistance under this program is sought, including how the eligible entity will carry out the required activities described in section 404D(a) of the HEA;
(b) Describes, in the case of an eligible entity described in section 404A(c)(2) of the HEA that chooses to provide scholarships, or an eligible entity described in section 404A(c)(1) of the HEA, how the eligible entity will meet the requirements of section 404E of the HEA;
(c) Describes, in the case of an eligible entity described in section 404A(c)(2) of the HEA that requests a reduced match percentage under subsection (b)(2), how such reduction will assist the entity to provide the scholarships described in subsection (b)(2)(A)(ii);
(d) Provides assurances that adequate administrative and support staff will be responsible for coordinating the activities described in section 404D of the HEA;
(e) Provides assurances that activities assisted under this program will not displace an employee or eliminate a position at a school assisted under this program, including a partial displacement such as a reduction in hours, wages, or employment benefits;
(f) Describes, in the case of an eligible entity described in section 404A(c)(1) of the HEA that chooses to use a cohort approach, or an eligible entity described in section 404A(c)(2) of the HEA, how the eligible entity will define the cohorts of the students served by the eligible entity pursuant to section 404B(d) of the HEA, and how the eligible entity will serve the cohorts through grade 12, including—
(i) How vacancies in the program under this program will be filled; and
(ii) How the eligible entity will serve students attending different secondary schools;
(g) Describes how the eligible entity will coordinate programs under this program with other existing Federal, State, or local programs to avoid duplication and maximize the number of students served;
(h) Provides such additional assurances as the Secretary determines necessary to ensure compliance with the requirements of this program;
(i) Provides information about the activities that will be carried out by the eligible entity to support systemic changes from which future cohorts of students will benefit; and
(j) Describes the sources of matching funds that will enable the eligible entity to meet the matching requirement described in subsection (b).
4.
5.
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Applications that do not follow the formatting recommendations will not be penalized.
We recommend the following standards:
• A “page” is 8.5″ x 11″, on one side only, with 1″ margins.
• Double-space all text in the application narrative and single-space titles, headings, footnotes, quotations, references, and captions.
• Use a 12 point font.
• Use an easily readable font such as Times New Roman, Courier, Courier New, or Arial.
1.
a.
(1) The Secretary considers the need for the proposed project.
(2) In determining the need for the proposed project, the Secretary considers the following factors:
(i) The magnitude or severity of the problem to be addressed by the proposed project; and
(ii) The extent to which specific gaps or weaknesses in services, infrastructure, or opportunities have been identified and will be addressed by the proposed project, including the nature and magnitude of those gaps or weaknesses.
b.
(1) The Secretary considers the quality of the project design.
(2) In determining the quality of project design, the Secretary considers the following factors:
(i) The extent to which the goals, objectives, and outcomes to be achieved by the proposed project are clearly specified and measurable;
(ii) The extent to which the project design reflects up-to-date research and the replication of effective practices; and
(iii) The extent to which the project supports systemic changes from which future cohorts of students will benefit.
(3) The extent to which the proposed project demonstrates a rationale (as defined in 34 CFR 77.1(c) and in this Notice).
c.
(1) The Secretary considers the quality of the services to be provided by the proposed project.
(2) In determining the quality of project services provided by the
(3) In addition, the Secretary considers the following factors:
(i) The extent to which the project services are likely to provide comprehensive mentoring, outreach, and supportive services to students, including the following activities: Information regarding financial aid for postsecondary education to participating students, encouraging student enrollment in rigorous and challenging curricula and coursework in order to reduce the need for remedial coursework at the postsecondary level, and improving the number of participating students who obtain a secondary school diploma and complete applications for and enroll in a program of postsecondary education; and
(ii) The extent to which the services to be provided by the proposed project involve the collaboration of appropriate partners for maximizing the effectiveness of project services.
d.
(1) The Secretary considers the quality of the personnel who will carry out the proposed project.
(2) In determining the quality of project personnel, the Secretary considers the extent to which the applicant encourages applications for employment from persons who are members of groups that have traditionally been underrepresented based on race, color, national origin, gender, age or disability.
(3) In addition, the Secretary considers the following factors:
(i) The qualifications, including relevant training and experience, of the project director or principal investigator; and
(ii) The qualifications, including relevant training and experience, of key personnel.
e.
(1) The Secretary considers the quality of the management plan for the proposed project.
(2) In determining the quality of the management plan for the proposed project, the Secretary considers the following factors:
(i) The adequacy of the management plan to achieve the objectives of the proposed project on time and within budget, including clearly defined responsibilities, timelines, and milestones for accomplishing project tasks;
(ii) The adequacy of procedures for ensuring feedback and continuous improvement in the operation of the proposed project;
(iii) The extent to which the time commitments of the project director and other key project personnel are appropriate and adequate to meet the objectives of the proposed project; and
(iv) How the applicant will ensure that a diversity of perspectives are brought to bear in the operation of the proposed project, including those of parents, teachers, the business community, a variety of disciplinary and professional fields, recipients or beneficiaries of services, or others, as appropriate.
f.
(1) The Secretary considers the quality of the evaluation to be conducted of the proposed project.
(2) In determining the quality of the project evaluation, the Secretary considers the following factors:
(i) The extent to which the methods of evaluation are thorough, feasible, and appropriate to the goals, objectives, and outcomes of the proposed project;
(ii) The extent to which the methods of evaluation include the use of objective performance measures that are clearly related to the intended outcomes of the project and will produce quantitative and qualitative data to the extent possible;
(iii) The extent to which the methods of evaluation will provide performance feedback and permit periodic assessment of progress toward achieving intended outcomes;
(iv) The extent to which the evaluation will provide guidance about effective strategies suitable for replication or testing in other settings; and
(v) The extent to which the methods of evaluation will, if well-implemented, produce promising evidence (as defined in 34 CFR 77.1(c)) about the project's effectiveness.
g.
(1) The Secretary considers the adequacy of resources for the proposed project.
(2) In determining the adequacy of resources for the proposed project, the Secretary considers the following factors:
(i) The adequacy of support, including facilities, equipment, supplies and other resources from the applicant organization or the lead applicant organization;
(ii) The relevance and demonstrated commitment of each partner in the proposed project to the implementation and success of the project;
(iii) The extent to which the costs are reasonable in relation to the number of persons to be served and to the anticipated results and benefits; and
(iv) The potential for continued support of the project after Federal funding ends, including, as appropriate, the demonstrated commitment of appropriate entities to such support.
2.
In addition, in making a competitive grant award, the Secretary requires various assurances including those applicable to Federal civil rights laws that prohibit discrimination in programs or activities receiving Federal financial assistance from the Department of Education (34 CFR 100.4, 104.5, 106.4, 108.8, and 110.23) as well as all applicable requirements of all other Federal laws, executive orders, regulations, and policies governing this program.
For this competition, a panel of non-Federal reviewers will review each application in accordance with the selection criteria in 34 CFR 75.217(d)(3), as required by 20 U.S.C. 1070-a23(d). The individual scores of the reviewers will be added and the sum divided by the number of reviewers to determine the peer review score received in the review process.
If there are insufficient funds for all applications with the same total scores, to the extent practicable the Secretary will consider the distribution of grant awards based on the geographic distribution of such grant awards and the distribution between urban and rural applicants for the GEAR UP program consistent with 20 U.S.C. 1070a-22(a)(3).
3.
4.
Please note that, if the total value of your currently active grants, cooperative agreements, and procurement contracts from the Federal Government exceeds $10,000,000, the reporting requirements in 2 CFR part 200, Appendix XII, require you to report certain integrity information to FAPIIS semiannually. Please review the requirements in 2 CFR part 200, Appendix XII, if this grant plus all the other Federal funds you receive exceed $10,000,000.
1.
If your application is not evaluated or not selected for funding, we will notify you.
2.
We reference the regulations outlining the terms and conditions of an award in the
3.
4.
(b) At the end of your project period, you must submit a final performance report, including financial information, as directed by the Secretary. If you receive a multiyear award, you must submit an annual performance report that provides the most current performance and financial expenditure information as directed by the Secretary under 34 CFR 75.118. The Secretary may also require more frequent performance reports under 34 CFR 75.720(c). For specific requirements on reporting, please go to
(c) Under 34 CFR 75.250(b), the Secretary may provide a grantee with additional funding for data collection analysis and reporting. In this case the Secretary establishes a data collection period.
5.
The effectiveness of this program depends on the rate at which program participants complete high school and enroll in and complete a postsecondary education. Under the Government Performance and Results Act of 1993 (GPRA), we developed the following performance measures to track progress toward achieving the program's goals:
1. The percentage of GEAR UP students who pass Pre-Algebra by the end of 8th grade.
2. The percentage of GEAR UP students who pass Algebra 1 by the end of 9th grade.
3. The percentage of GEAR UP students who take two years of mathematics beyond Algebra 1 by 12th grade.
4. The percentage of GEAR UP students who are on track for graduation at the end of each grade.
5. The percentage of GEAR UP students who are on track to apply for college as measured by completion of the SAT or ACT by the end of 11th grade.
6. The percentage of GEAR UP students who graduate from high school.
7. The percentage of GEAR UP students who complete the Free Application for Federal Student Aid.
8. The percentage of GEAR UP students and former GEAR UP students who are enrolled at an IHE.
9. The percentage of GEAR UP students who place into college-level math and English without need for remediation.
10. The percentage of current GEAR UP students and former GEAR UP students who are on track to graduate from an IHE one year after enrolling in an IHE.
In addition, to assess the efficiency of the program, we track the average cost, in Federal funds, of achieving a successful outcome, where success is defined as enrollment in a program of undergraduate instruction at an IHE of GEAR UP students immediately after high school graduation. These performance measures constitute GEAR UP's indicators of the success of the program. Accordingly, we request that applicants include these performance measures in conceptualizing the design, implementation, and evaluation of their proposed projects.
6.
In making a continuation grant, the Secretary also considers whether the grantee is operating in compliance with the assurances in its approved application, including those applicable to Federal civil rights laws that prohibit discrimination in programs or activities receiving Federal financial assistance from the Department (34 CFR 100.4, 104.5, 106.4, 108.8, and 110.23) as well as all applicable requirements, and policies governing this program.
Office of Electricity Delivery and Energy Reliability, DOE.
Notice of Application.
ALLETE, Inc., d/b/a Minnesota Power (Applicant or Minnesota Power) has applied to renew its authority to transmit electric energy from the United States to Canada pursuant to the Federal Power Act.
Comments, protests, or motions to intervene must be submitted on or before July 9, 2018.
Comments, protests, motions to intervene, or requests for more information should be addressed to: Office of Electricity Delivery and Energy Reliability, Mail Code: OE-20, U.S. Department of Energy, 1000 Independence Avenue SW, Washington, DC 20585-0350. Because of delays in handling conventional mail, it is recommended that documents be transmitted by overnight mail, by electronic mail to
Exports of electricity from the United States to a foreign country are regulated by the Department of Energy (DOE) pursuant to sections 301(b) and 402(f) of the Department of Energy Organization Act (42 U.S.C. 7151(b), 7172(f)) and require authorization under section 202(e) of the Federal Power Act (16 U.S.C. 824a(e)).
On June 10, 2013, DOE issued Order No. EA-196-D to Minnesota Power, which authorized the Applicant to transmit electric energy from the United States to Canada as a power marketer for a five-year term using existing international transmission facilities. That authority expires on June 4, 2018. On April 23, 2018, Minnesota Power filed an application with DOE for renewal of the export authority contained in Order No. EA-196 for an additional five-year term.
In its application, Minnesota Power states that it owns electric generation and transmission facilities and sells and distributes electricity within its northern Minnesota service territory. The electric energy that Minnesota Power proposes to export to Canada would be surplus energy purchased from third parties such as electric utilities and Federal power marketing agencies pursuant to voluntary agreements. The existing international transmission facilities to be utilized by Shell Energy have previously been authorized by Presidential Permits issued pursuant to Executive Order 10485, as amended, and are appropriate for open access transmission by third parties.
Comments and other filings concerning Minnesota Power's application to export electric energy to Canada should be clearly marked with OE Docket No. EA-196-E. An additional copy is to be provided directly to Christopher D. Anderson, ALLETE, Inc., 30 West Superior Street, Duluth, MN 55802.
A final decision will be made on this application after the environmental impacts have been evaluated pursuant to DOE's National Environmental Policy Act Implementing Procedures (10 CFR part 1021) and after a determination is made by DOE that the proposed action will not have an adverse impact on the sufficiency of supply or reliability of the U.S. electric power supply system.
Copies of this application will be made available, upon request, for public inspection and copying at the address provided above, by accessing the program website at
Office of Electricity Delivery and Energy Reliability, DOE.
Notice of Filing.
On May 17, 2018, Clean Energy Future—Lordstown, LLC, as owner and operator of a new baseload electric generating powerplant, submitted a coal capability self-certification to the Department of Energy (DOE). The FUA and regulations thereunder require DOE to publish a notice of filing of self-certification in the
Copies of coal capability self-certification filings are available for
Christopher Lawrence at (202) 586-5260.
On May 17, 2018, Clean Energy Future—Lordstown, LLC, as owner and operator of a new baseload electric generating powerplant, submitted a coal capability self-certification to the Department of Energy (DOE) pursuant to § 201(d) of the Powerplant and Industrial Fuel Use Act of 1978 (FUA), as amended, and DOE regulations in 10 CFR 501.60, 61. The FUA and regulations thereunder require DOE to publish a notice of filing of self-certification in the
The following owner of a proposed new baseload electric generating powerplant has filed a self-certification of coal-capability with DOE pursuant to FUA section 201(d) and in accordance with DOE regulations in 10 CFR 501.60, 61:
National Energy Technology Laboratory, Department of Energy.
Notice of intent to grant an exclusive copyright license.
The National Energy Technology Laboratory (NETL) hereby gives notice that the Department of Energy (DOE) intends to grant an exclusive license to practice the copyrighted software titled “The Variable Grid Tool V.1,” to VariGrid Explorations, Inc., having its principal place of business in Missouri City, Texas. The copyright is owned by the United States of America, as represented by DOE, via copyright assignment.
Written comments, objections, or nonexclusive license applications must be received at the
Comments, applications for nonexclusive licenses, or objections relating to the prospective exclusive license should be submitted to Jessica Lamp, Technology Transfer Program Manager, U.S. Department of Energy, National Energy Technology Laboratory, P.O. Box 10940, Pittsburgh, PA 15236-0940 or via facsimile to (412) 386-4183.
Jessica Lamp, Technology Transfer Program Manager, U.S. Department of Energy, National Energy Technology Laboratory, P.O. Box 10940, Pittsburgh, PA 15236; Telephone (412) 386-7417; Email:
VariGrid Explorations, Inc., has applied for an exclusive license to practice the copyrighted software and has a plan for commercialization of the software. DOE intends to grant the license, unless within 15 days of publication of this notice, NETL's Technology Transfer Program Manager (contact information listed) receives in writing any of the following, together with supporting documents:
(i) A statement from any person setting forth reasons why it would not be in the best interest of the United States to grant the proposed license; or
(ii) An application for a nonexclusive license to the copyrighted software, in which applicant states that it already has brought the software to practical application or is likely to bring the software to practical application expeditiously.
This is a supplemental notice in the above-referenced proceeding of Stoneray Power Partners, 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 June 21, 2018.
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 website 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 Copenhagen Wind Farm, 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 June 21, 2018.
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 website 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 East Hampton Energy Storage Center, 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 June 21, 2018.
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 website 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 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:
This is a supplemental notice in the above-referenced proceeding of Montauk Energy Storage Center, 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 June 21, 2018.
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 website 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
Environmental Protection Agency (EPA).
Notice of tentative approval.
Notice is hereby given that the State of Nevada revised its approved Public Water System Supervision Program (PWSSP) under the federal Safe Drinking Water Act (SDWA) by adopting the Ground Water Rule, the Long Term 2 Enhanced Surface Water Treatment Rule, the Revised Total Coliform Rule, and the Stage 2 Disinfectants and Disinfection Byproducts Rule. The Environmental Protection Agency (EPA) has determined that these revisions by the State of Nevada are no less stringent than the corresponding Federal regulations and otherwise meet applicable SDWA primacy requirements. Therefore, EPA intends to approve these revisions to the State of Nevada's PWSSP.
Request for a public hearing must be received on or before July 9, 2018.
All documents relating to this determination are available for inspection between the hours of 8:30 a.m. and 4:00 p.m., Monday through Friday, except official State holidays and official Federal holidays, at the following offices: Nevada Department of Environmental Protection, Admin Office, 901 South Stewart Street, Suite 4001, Carson City, NV 89701; and United States Environmental Protection Agency, Region 9, Drinking Water Management Section, 75 Hawthorne Street (WTR-3-1), San Francisco, California 94105. Documents relating to this determination are also available online at
Jacob Jenzen, EPA Region 9, Drinking Water Management Section, at the address given above; telephone number: (415) 972-3570; email address:
EPA approved the State of Nevada's original application for PWSSP primary enforcement authority which, following the public notice period, became effective on February 27, 1978 (43 FR 8030). EPA has approved various revisions to Nevada's primacy program since then.
Any interested party may request a public hearing on this determination. A request for a public hearing must be submitted by July 9, 2018, to the Regional Administrator at the EPA Region 9 address shown above. Any request for a public hearing shall include the following information: 1. The name, address, and telephone number of the individual, organization, or other entity requesting a hearing; 2. A brief statement of the requesting person's interest in the Regional Administrator's determination and a brief statement of the information that the requesting person intends to submit at such hearing; and 3. The signature of the individual making the request, or, if the request is made on behalf of an organization or other entity, the signature of a responsible official of the organization or other entity. The Regional Administrator may deny frivolous or insubstantial requests for a hearing. If a valid request for a public hearing is made within the requested timeframe, a public hearing will be held and a notice of such hearing will be given in the
If EPA Region 9 does not receive a timely and appropriate request for a hearing and the Regional Administrator does not elect to hold a hearing, this determination shall become final and effective on July 9, 2018, and no further public notice will be issued.
Section 1413 of the Safe Drinking Water Act, 42 U.S.C. 300g-2 (1996), and 40 CFR part 142 of the National Primary Drinking Water Regulations.
Farm Credit Administration.
Notice, regular meeting.
Notice is hereby given, pursuant to the Government in the Sunshine Act, of the regular meeting of the Farm Credit Administration Board (Board).
The regular meeting of the Board will be held at the offices of the Farm Credit Administration in McLean, Virginia, on June 14, 2018, from 9:00 a.m. until such time as the Board concludes its business.
Farm Credit Administration, 1501 Farm Credit Drive, McLean, Virginia 22102-5090. Submit attendance requests via email to
Dale L. Aultman, Secretary to the Farm Credit Administration Board, (703) 883-4009, TTY (703) 883-4056,
Parts of this meeting of the Board will be open to the public (limited space available) and parts will be closed to the public. Please send an email to
*Session Closed-Exempt pursuant to 5 U.S.C. 552b(c)(8) and (9).
Federal Accounting Standards Advisory Board.
Notice.
Pursuant to 31 U.S.C. 3511(d), the Federal Advisory Committee Act (Pub. L. 92-463), as amended, and the FASAB Rules Of Procedure, as amended in October 2010, notice is hereby given that the Federal Accounting Standards Advisory Board (FASAB) has issued Statement of Federal Financial Accounting Standards 55,
The Statement is available on the FASAB website at
Ms. Wendy M. Payne, Executive Director, 441 G Street NW, Suite 1155, Washington, DC 20548, or call (202) 512-7350.
Federal Advisory Committee Act, Pub. L. 92-463.
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, 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. 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 Commission may not conduct or sponsor a collection of information unless it displays a currently valid Office of Management and Budget (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 comments should be submitted on or before July 9, 2018. 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 contacts listed below as soon as possible.
Direct all PRA comments to Nicholas A. Fraser, OMB, via email
For additional information or copies of the information collection, contact Nicole Ongele at (202) 418-2991. To view a copy of this information collection request (ICR) submitted to OMB: (1) Go to the web page <
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.
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 Commission's Public Safety and Homeland Security Bureau (PSHSB) developed the Disaster Information Reporting System (DIRS) that uses electronic forms to collect Emergency Contact Information forms and through which participants may inform the Commission of damage to communications infrastructure and facilities due to major emergencies and may request resources for restoration. The Commission updated the process by increasing the number of reporting entities to ensure inclusion of wireless, wireline, broadcast, cable, VoIP, and broadband internet access communications providers. The Commission is requesting a renewal of the currently approved collection. It is imperative that the Disaster Information Reporting System be in place so that the Commission has an accurate picture of the communications landscape during disasters.
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, 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. 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 Commission may not conduct or sponsor a collection of information unless it displays a currently valid Office of Management and Budget (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 comments should be submitted on or before July 9, 2018. 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 contacts listed below as soon as possible.
Direct all PRA comments to Nicholas A. Fraser, OMB, via email
For additional information or copies of the information collection, contact Nicole
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.
In the Phase II auction, service providers will compete to receive support of up to $1.98 billion over 10 years to offer voice and broadband service in unserved high-cost areas. The information collection requirements reported under this new collection are the result of several Commission decisions to implement reform adopted in the USF/ICC Transformation Order and move forward with conducting the Phase II auction. In the April 2014 Connect America Order, WC Docket No. 10-90 et al., FCC 14-54, the Commission adopted various rules regarding participation in the Phase II auction, the term of support, and the eligible telecommunications carrier (ETC) designation process. In the Phase II Auction Order, WC Docket No. 10-90 et al., FCC 16-64, the Commission adopted rules to govern the Phase II auction, including the adoption of a two-stage application process, which includes a pre-auction short-form application to be submitted by parties interested in bidding in the Phase II auction and a post-auction long-form application that must be submitted by winning bidders seeking to become authorized to receive Phase II auction support. The Commission concluded, based on its experience with auctions and consistent with the record, that this two-stage application process balances the need to collect information essential to conducting a successful auction and authorizing Phase II support with administrative efficiency.
On January 30, 2018, the Commission adopted a public notice that established the final procedures for the Phase II auction, including the long-form application disclosure and certification requirements for winning bidders seeking to become authorized to receive Phase II auction support. See Phase II Auction Procedures Public Notice, WC Docket No. 17-182 et al., FCC 18-6. The Commission also adopted the Phase II Auction Order on Reconsideration, WC Docket No. 10-90 et al., FCC 18-5, which modified the Commission's letter of credit rules to provide some additional relief for Phase II auction support recipients by reducing the costs of maintaining a letter of credit.
Under this information collection, the Commission will collect information from winning bidders to determine the recipients of Phase II auction support. To aid in collecting this information, the Commission has created FCC Form 683, which the public will use to provide the disclosures and certifications that must be made by Phase II auction winning bidders in the Connect America Fund Phase II auction seeking to become authorized for Phase II support.
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, 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. 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 Commission may not conduct or sponsor a collection of information unless it displays a currently valid Office of Management and Budget (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 comments should be submitted on or before July 9, 2018. 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 contacts listed below as soon as possible.
Direct all PRA comments to Nicholas A. Fraser, OMB, via email
For additional information or copies of the information collection, contact Cathy Williams at (202) 418-2918. To view a copy of this information collection request (ICR) submitted to OMB: (1) Go to the web page
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. 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.
On December 21, 2001, the Commission released the 2001 TRS Cost Recovery Order, document FCC 01-371, published at 67 FR 4203, January 29, 2002, in which the Commission:
(a) Directed the Interstate Telecommunications Relay Services (TRS) Fund (TRS Fund) administrator to
(b) required TRS providers to submit certain projected TRS-related cost and demand data to the TRS Fund administrator to be used to calculate the rate; and
(c) directed the TRS Fund administrator to expand its form for providers to itemize their actual and projected costs and demand data, to include specific sections to capture speech-to-speech (STS) and video relay service (VRS) costs and minutes of use.
In 2003, the Commission released the 2003 Second Improved TRS Order, published at 68 FR 50973, August 25, 2003, which among other things required that TRS providers offer certain local exchange carrier (LEC)-based improved services and features where technologically feasible, including a speed dialing requirement which may entail voluntary recordkeeping for TRS providers to maintain a list of telephone numbers. See also 47 CFR 64.604(a)(3)(vi)(B). In 2007, the Commission released the Section 225/255 VoIP Report and Order, published at 72 FR 43546, August 6, 2007, extending the disability access requirements that apply to telecommunications service providers and equipment manufacturers under 47 U.S.C. 225, 255 to interconnected voice over internet protocol (VoIP) service providers and equipment manufacturers. As a result, under rules implementing section 225 of the Act, interconnected VoIP service providers are required to publicize information about telecommunications relay services (TRS) and 711 abbreviated dialing access to TRS. See also 47 CFR 64.604(c)(3).
In 2007, the Commission also released the 2007 Cost Recovery Report and Order and Declaratory Ruling, published at 73 FR 3197, January 17, 2008, in which the Commission:
(a) Adopted a new cost recovery methodology for interstate traditional TRS and interstate STS based on the Multi-state Average Rate Structure (MARS) plan, under which interstate TRS compensation rates are determined by weighted average of the states' intrastate compensation rates, and which includes for STS additional compensation approved by the Commission for STS outreach;
(b) requires STS providers to file a report annually with the TRS Fund administrator and the Commission on their specific outreach efforts directly attributable to the additional compensation approved by the Commission for STS outreach.
(c) adopted a new cost recovery methodology for interstate captioned telephone service (CTS), as well as internet Protocol captioned telephone service (IP CTS), based on the MARS plan;
(d) adopted a cost recovery methodology for internet Protocol (IP) Relay based on price caps;
(e) adopted a cost recovery methodology for VRS that adopted tiered rates based on call volume;
(f) clarified the nature and extent that certain categories of costs are compensable from the Fund; and
(g) addressed certain issues concerning the management and oversight of the Fund, including prohibiting financial incentives offered to consumers to make relay calls.
Federal Communications Commission.
The Federal Communications Commission will hold an Open Meeting on the subjects listed below on Thursday, June 7, 2018. Please note the meeting is scheduled to commence at 11:30 a.m. in Room TW-C305, at 445 12th Street SW, Washington, DC. This is a change from the usual 10:30 a.m. Open Meeting start time.
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, 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. 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 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 Office of Management and Budget (OMB) control number.
Written PRA comments should be submitted on or before August 6, 2018. 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.
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 companies listed in this notice have applied to the Board for approval, pursuant to the Bank Holding Company Act of 1956 (12 U.S.C. 1841
The applications listed below, as well as other related filings required by the Board, are available for immediate inspection at the Federal Reserve Bank indicated. The applications will also be available for inspection at the offices of the Board of Governors. Interested persons may express their views in writing on the standards enumerated in the BHC Act (12 U.S.C. 1842(c)). If the proposal also involves the acquisition of a nonbanking company, the review also includes whether the acquisition of the nonbanking company complies with the standards in section 4 of the BHC Act (12 U.S.C. 1843). Unless otherwise noted, nonbanking activities will be conducted throughout the United States.
Unless otherwise noted, comments regarding each of these applications must be received at the Reserve Bank indicated or the offices of the Board of Governors not later than July 2, 2018.
A. Federal Reserve Bank of St. Louis (David L. Hubbard, Senior Manager) P.O. Box 442, St. Louis, Missouri 63166-2034. Comments can also be sent electronically to
1.
Centers for Disease Control and Prevention (CDC), Department of Health and Human Services (HHS).
Notice with comment period.
The Centers for Disease Control and Prevention (CDC), as part of its continuing effort to reduce public burden and maximize the utility of government information, invites the general public and other Federal agencies the opportunity to comment on a proposed and/or continuing information collection, as required by the Paperwork Reduction Act of 1995. This notice invites comment on a proposed information collection project titled Traumatic Brain Injury Disparities in Rural Areas (TBIDRA). This study will conduct a formative research to understand the challenges that rural healthcare providers face when diagnosing, treating, and managing traumatic brain injury (TBI) and develop a knowledge base to address gaps in services to improve clinical care and TBI outcomes in rural communities.
CDC must receive written comments on or before August 6, 2018.
You may submit comments, identified by Docket No. CDC-2018-0052 by any of the following methods:
•
•
To request more information on the proposed project or to obtain a copy of the information collection plan and instruments, contact Jeffery M. Zirger, 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
The OMB is particularly interested in comments that will help:
1. 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;
2. 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;
3. Enhance the quality, utility, and clarity of the information to be collected; and
4. 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,
5. Assess information collection costs.
Traumatic Brain Injury Disparities in Rural Areas (TBIDRA)—New—National Center for Injury Prevention and Control (NCIPC), Centers for Disease Control and Prevention (CDC).
Traumatic Brain Injury (TBI) is a significant public health concern in the United States, research indicates that residents of rural areas have both higher incidence and higher mortality rates from TBI than do residents of urban areas, and that the prevalence of TBI-related disability in rural geographical areas is higher than in urban and suburban areas. The obstacles healthcare providers and patients face in rural areas are vastly different than those in urban areas. There is little published research specifically related to the challenges rural providers face in TBI diagnosis and treatment, and even less examination into effective ways to address gaps in service and improve TBI outcomes. The National Center for Injury Prevention and Control at the CDC, in a 2015 “Report to Congress on TBI in the United States,” determined that certain population groups, including residents of rural geographic areas, require special consideration when it comes to researching TBI.
This is a new Information Collection Request for 2 years to collect information on challenges that rural healthcare providers face in diagnosing, treating, and managing TBI of all severities and develop a knowledge base upon which we can begin to address gaps in services to improve clinical care and TBI outcomes in rural communities. The target population for the data collection effort includes physicians, nurse practitioners (NPs), and physician assistants (PAs) in selected specialties (general or family practice, emergency medicine, pediatrics) working in direct patient care in rural and urban areas. The focus of the study is rural healthcare providers; urban healthcare providers will be included in this study to allow for comparison in identifying the distinct challenges and opportunities for rural healthcare providers. This study has two data collection methods. A web survey to gather quantitative data on the unique challenges faced by rural clinicians, and focus groups to gain deeper insight into the context supporting and/or inhibiting access to comprehensive TBI evaluation and treatment, the study will collect qualitative data through focus groups with rural clinicians.
The proposed information collection is authorized by the Public Health Services Act (PHS Act) which provides the legislative means for states to advance public health across the lifespan and to reduce health disparities.
The total estimated annualized burden hours is 200. There are no costs to respondents other than their time.
Food and Drug Administration, HHS.
Notice.
The Food and Drug Administration (FDA or Agency) is announcing a publication containing modifications the Agency is making to the list of standards FDA recognizes for use in premarket reviews (FDA Recognized Consensus Standards). This publication, entitled “Modifications to the List of Recognized Standards, Recognition List Number: 049” (Recognition List Number: 049), will assist manufacturers who elect to declare conformity with consensus standards to meet certain requirements for medical devices.
These modifications to the list of recognized standards are applicable June 7, 2018.
You may submit comments as follows:
Submit electronic comments in the following way:
•
• If you want to submit a comment with confidential information that you do not wish to be made available to the public, submit the comment as a written/paper submission and in the manner detailed (see “Written/Paper Submissions” and “Instructions”).
Submit written/paper submissions as follows:
•
• For written/paper comments submitted to the Dockets Management Staff, FDA will post your comment, as well as any attachments, except for information submitted, marked and identified, as confidential, if submitted as detailed in “Instructions.”
• Confidential Submissions—To submit a comment with confidential information that you do not wish to be made publicly available, submit your comments only as a written/paper submission. You should submit two copies total. One copy will include the information you claim to be confidential with a heading or cover note that states “THIS DOCUMENT CONTAINS CONFIDENTIAL INFORMATION”. The Agency will review this copy, including the claimed confidential information, in its consideration of comments. The second copy, which will have the claimed confidential information redacted/blacked out, will be available for public viewing and posted on
An electronic copy of Recognition List Number: 049 is available on the internet at
See section IV for electronic access to the searchable database for the current list of FDA recognized consensus standards, including Recognition List Number: 049 modifications and other standards related information. Submit written requests for a single hard copy of the document entitled “Modifications to the List of Recognized Standards, Recognition List Number: 049” to Scott Colburn, Center for Devices and Radiological Health, Food and Drug Administration, 10903 New Hampshire Ave., Bldg. 66, Rm. 5514, Silver Spring, MD 20993. Send one self-addressed adhesive label to assist that office in processing your request, or fax your request to 301-847-8144.
Scott Colburn, Center for Devices and Radiological Health, Food and Drug Administration, 10903 New Hampshire Ave., Bldg. 66, Rm. 5514, Silver Spring, MD 20993, 301-796-6287,
Section 204 of the Food and Drug Administration Modernization Act of 1997 (FDAMA) (Pub. L. 105-115) amended section 514 of the Federal Food, Drug, and Cosmetic Act (FD&C Act) (21 U.S.C. 360d). Amended section 514 allows FDA to recognize consensus standards developed by international and national organizations for use in satisfying portions of device premarket review submissions or other requirements.
In the
Modifications to the initial list of recognized standards, as published in the
These notices describe the addition, withdrawal, and revision of certain standards recognized by FDA. The Agency maintains hypertext markup language (HTML) and portable document format (PDF) versions of the list of FDA Recognized Consensus Standards. Additional information on the Agency's standards program is available at
FDA is announcing the addition, withdrawal, correction, and revision of certain consensus standards the Agency is recognizing for use in premarket submissions and other requirements for devices. FDA is incorporating these modifications to the list of FDA Recognized Consensus Standards in the Agency's searchable database. FDA is using the term “Recognition List Number: 049” to identify the current modifications.
In table 1, FDA describes the following modifications: (1) The withdrawal of standards and their replacement by others, if applicable; (2) the correction of errors made by FDA in listing previously recognized standards; and (3) the changes to the supplementary information sheets of recognized standards that describe revisions to the applicability of the standards.
In section III, FDA lists modifications the Agency is making that involve the initial addition of standards not previously recognized by FDA.
In table 2, FDA provides the listing of new entries and consensus standards added as modifications to the list of recognized standards under Recognition List Number: 049.
FDA maintains the current list of FDA Recognized Consensus Standards in a searchable database that may be accessed at
Any person may recommend consensus standards as candidates for recognition under section 514 of the FD&C Act by submitting such recommendations, with reasons for the recommendation, to
Food and Drug Administration, HHS.
Notice of availability.
The Food and Drug Administration (FDA or Agency) is announcing the availability of a draft guidance for industry entitled “Prescription Drug User Fee Act Waivers for Fixed-Combination Antiretroviral Drugs for the President's Emergency Plan for AIDS Relief.” This draft guidance describes circumstances under which an applicant may be eligible for a barrier-to-innovation waiver for some new drug applications (NDAs) for fixed-combination versions and single-entity versions of previously approved antiretroviral therapies for the treatment of human immunodeficiency virus (HIV).
Submit either electronic or written comments on the guidance August 6, 2018 to ensure that the Agency considers your comment on this draft guidance before it begins work on the final version of the guidance.
You may submit comments on any guidance at any time as follows:
Submit electronic comments in the following way:
•
• If you want to submit a comment with confidential information that you do not wish to be made available to the public, submit the comment as a written/paper submission and in the
Submit written/paper submissions as follows:
•
• For written/paper comments submitted to the Dockets Management Staff, FDA will post your comment, as well as any attachments, except for information submitted, marked and identified, as confidential, if submitted as detailed in “Instructions.”
• Confidential Submissions—To submit a comment with confidential information that you do not wish to be made publicly available, submit your comments only as a written/paper submission. You should submit two copies total. One copy will include the information you claim to be confidential with a heading or cover note that states “THIS DOCUMENT CONTAINS CONFIDENTIAL INFORMATION.” The Agency will review this copy, including the claimed confidential information, in its consideration of comments. The second copy, which will have the claimed confidential information redacted/blacked out, will be available for public viewing and posted on
You may submit comments on any guidance at any time (see 21 CFR 10.115(g)(5)).
Submit written requests for single copies of the draft guidance to the Division of Drug Information, Center for Drug Evaluation and Research, Food and Drug Administration, 10001 New Hampshire Ave., Hillandale Building, 4th Floor, Silver Spring, MD 20993-0002. Send one self-addressed adhesive label to assist that office in processing your requests. See the
Ted Palat, Center for Drug Evaluation and Research, Food and Drug Administration, 10001 New Hampshire Ave., Rm. 2185, Silver Spring, MD 20993, 240-402-8739,
FDA is announcing the availability of a draft guidance for industry entitled “Prescription Drug User Fee Act Waivers for Fixed-Combination Antiretroviral Drugs for the President's Emergency Plan for AIDS Relief.” The draft guidance describes the circumstances under which certain applications for fixed-combination and single-entity versions of previously approved antiretroviral therapies for the treatment of HIV under the President's Emergency Plan for AIDS Relief (PEPFAR) may be eligible for a barrier-to-innovation waiver.
In October 2006, to encourage applicants to submit applications for HIV combination therapies that can be used in PEPFAR, FDA issued a final guidance entitled “Fixed Dose Combinations, Co-Packaged Drug Products, and Single-Entity Versions of Previously Approved Antiretrovirals for the Treatment of HIV” (fixed-combination guidance). Attachments to the fixed-combination guidance describe some scenarios for approval of fixed-combination for the treatment of HIV and provide examples of drug combinations considered acceptable as fixed combinations and examples of those not considered acceptable as fixed combinations. Although the 2006 fixed-combination guidance focuses on fixed combinations, the scientific principles outlined in the guidance also apply to single ingredient versions of antiretroviral drugs that are components of regimens listed in Attachment B. The guidance also explains that the Federal Food, Drug, and Cosmetic Act (FD&C Act) provides for certain circumstances in which FDA may grant a waiver or reduction in user fees.
This draft guidance is a revision of the guidance for industry entitled “User Fee Waivers for FDC and Co-Packaged HIV Drugs for PEPFAR,” issued February 2007. In this guidance, FDA provides information about the circumstances under which certain applications for fixed-combination and single-entity versions of previously approved antiretroviral therapies for the treatment of HIV under PEPFAR may be eligible for a barrier-to-innovation waiver.
This draft guidance is being issued consistent with FDA's good guidance practices regulation (21 CFR 10.115). The draft guidance, when finalized, will represent the current thinking of FDA on “Prescription Drug User Fee Act Waivers for Fixed-Combination Antiretroviral Drugs for the President's Emergency Plan for AIDS Relief.” It does not establish any rights for any person and is not binding on FDA or the public. You can use an alternative approach if it satisfies the requirements of the applicable statutes and regulations. This guidance is not subject to Executive Order 12866.
This draft guidance contains information collection provisions that 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 burden of information collection associated with requesting waivers of user fees (including PEPFAR waivers) was previously approved under OMB control number 0910-0693. The burden for completing and submitting Form FDA 3397 (Prescription Drug User Fee Coversheet) is not included in this analysis as the burden is already approved under OMB control number 0910-0297. The collections of information associated with submission of a new drug application or biologics license application are approved under OMB control numbers 0910-0001 and 0910-0338, respectively.
Persons with access to the internet may obtain the draft guidance at either
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 (PRA).
Fax written comments on the collection of information by July 9, 2018.
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
JonnaLynn Capezzuto, Office of Operations, Food and Drug Administration, Three White Flint North, 10A-12M, 11601 Landsdown St., North Bethesda, MD 20852, 301-796-3794,
In compliance with 44 U.S.C. 3507, FDA has submitted the following proposed collection of information to OMB for review and clearance.
Section 403(r)(3)(A) of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 343(r)(3)(A)) provides for the use of food label statements characterizing a relationship of any nutrient of the type required to be in the label or labeling of the food to a disease or a health-related condition only where that statement meets the requirements of the regulations issued by the Secretary of Health and Human Services to authorize the use of such a health claim. Section 101.82 (21 CFR 101.82) of our regulations authorizes a health claim for food labels about soy protein and the risk of coronary heart disease. Accordingly, FDA established the previously referenced information collection in support of the regulation. In the
In the
FDA estimates the burden of this collection of information as follows:
Based on our current experience with the use of health claims, we estimate 25 firms market products bearing a soy protein/coronary heart disease health claim and that perhaps one of each firm's products might contain non-soy sources of protein along with soy protein. The records currently required to be retained under § 101.82(c)(2)(ii)(B) are the records,
Food and Drug Administration, HHS.
Notice.
The Food and Drug Administration (FDA or Agency) is announcing an opportunity for public
Submit either electronic or written comments on the collection of information by August 6, 2018.
You may submit comments as follows. Please note that late, untimely filed comments will not be considered. Electronic comments must be submitted on or before August 6, 2018. The
Submit electronic comments in the following way:
•
• If you want to submit a comment with confidential information that you do not wish to be made available to the public, submit the comment as a written/paper submission and in the manner detailed (see “Written/Paper Submissions” and “Instructions”).
Submit written/paper submissions as follows:
•
• For written/paper comments submitted to the Dockets Management Staff, FDA will post your comment, as well as any attachments, except for information submitted, marked and identified, as confidential, if submitted as detailed in “Instructions.”
• Confidential Submissions—To submit a comment with confidential information that you do not wish to be made publicly available, submit your comments only as a written/paper submission. You should submit two copies total. One copy will include the information you claim to be confidential with a heading or cover note that states “THIS DOCUMENT CONTAINS CONFIDENTIAL INFORMATION.” The Agency will review this copy, including the claimed confidential information, in its consideration of comments. The second copy, which will have the claimed confidential information redacted/blacked out, will be available for public viewing and posted on
Amber Sanford, Office of Operations, Food and Drug Administration, Three White Flint North, 10A-12M, 11601 Landsdown St., North Bethesda, MD 20852, 301-796-8867,
Under the 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. “Collection of information” is defined in 44 U.S.C. 3502(3) and 5 CFR 1320.3(c) and includes Agency requests or requirements that members of the public submit reports, keep records, or provide information to a third party. Section 3506(c)(2)(A) of the PRA (44 U.S.C. 3506(c)(2)(A)) requires Federal Agencies to provide a 60-day notice in the
With respect to the following collection of information, FDA invites comments on these topics: (1) Whether the proposed collection of information is necessary for the proper performance of FDA's functions, including whether the information will have practical utility; (2) the accuracy of FDA's estimate of the burden of the proposed collection of information, including the validity of the methodology and assumptions used; (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, when appropriate, and other forms of information technology.
FDA is requesting OMB approval for the reporting requirements contained in the FDA collection of information
FDA's NEPA regulations are in part 25 (21 CFR part 25). All applications or petitions requesting Agency action require the submission of a claim for categorical exclusion or an environmental assessment (EA). A categorical exclusion applies to certain classes of FDA-regulated actions that usually have little or no potential to cause significant environmental effects and are excluded from the requirements to prepare an EA or EIS. Section 25.15(a) and (d) specifies the procedures for submitting to FDA a claim for a categorical exclusion. Extraordinary circumstances (§ 25.21), which may result in significant environmental impacts, may exist for some actions that are usually categorically excluded. An EA provides information that is used to determine whether an FDA action could result in a significant environmental impact. Section 25.40(a) and (c) specifies the content requirements for EAs for non-excluded actions.
This collection of information is used by FDA to assess the environmental impact of Agency actions and to ensure that the public is informed of environmental analyses. Firms wishing to manufacture and market substances regulated under statutes for which FDA is responsible must, in most instances, submit applications requesting approval. Environmental information must be included in such applications for the purpose of determining whether the proposed action may have a significant impact on the environment. Where significant adverse events cannot be avoided, the Agency uses the submitted information as the basis for preparing and circulating to the public an EIS, made available through a
Any final EIS would contain additional information gathered by the Agency after the publication of the draft EIS, a copy or a summary of the comments received on the draft EIS, and the Agency's responses to the comments, including any revisions resulting from the comments or other information. When the Agency finds that no significant environmental effects are expected, the Agency prepares a finding of no significant impact.
FDA estimates the burden of this collection of information as follows:
Under §§ 312.23(a)(7)(iv)(e), 314.50(d)(1)(iii), and 314.94(a)(9)(i) (21 CFR 312.23(a)(7)(iv)(e), 314.50(d)(1)(iii), and 314.94(a)(9)(i)), each investigational new drug application (IND), new drug application (NDA), and abbreviated new drug application (ANDA) must contain a claim for categorical exclusion under § 25.30 or § 25.31, or an EA under § 25.40. Annually, FDA receives approximately 3,687 INDs from 2,456 sponsors; 140 NDAs from 116 applicants; 3,192 supplements to NDAs from 443 applicants; 28 biologic license applications (BLAs) from 22 applicants; 464 supplements to BLAs from 52 applicants; 1,152 ANDAs from 248 applicants; and 6,774 supplements to ANDAs from 384 applicants. FDA estimates that it receives approximately 15,437 claims for categorical exclusions as required under § 25.15(a) and (d) and 10 EAs as required under § 25.40(a) and (c). Based on information provided by the pharmaceutical industry, FDA estimates that it takes sponsors or applicants approximately 8 hours to prepare a claim for a categorical exclusion and approximately 3,400 hours to prepare an EA.
Under § 814.20(b)(11) (21 CFR 814.20(b)(11)), premarket approvals (PMAs) (original PMAs and supplements) must contain a claim for categorical exclusion under § 25.30 or § 25.34 or an EA under § 25.40. In 2017, FDA received an average of 50 claims (original PMAs and supplements) for categorical exclusions as required under § 25.15(a) and (d), and 0 EAs as required under § 25.40(a) and (c). FDA estimates that approximately 50 respondents will submit an average of 1 application for categorical exclusion annually. Based on information provided by sponsors, FDA estimates that it takes approximately 6 hours to prepare a claim for a categorical exclusion.
Under 21 CFR 601.2(a), BLAs as well as INDs (§ 312.23), NDAs (§ 314.50), ANDAs (§ 314.94), and PMAs (§ 814.20) must contain either a claim of categorical exclusion under § 25.30 or § 25.32 or an EA under § 25.40. Annually, FDA receives approximately 34 BLAs from 18 applicants, 801 BLA supplements to license applications from 156 applicants, 345 INDs from 256 sponsors, 1 NDA from 1 applicant, 26 supplements to NDAs from 8 applicants, 1 ANDA from 1 applicant, 1 supplement to ANDAs from 1 applicant, 8 PMAs from 3 applicants, and 33 PMA supplements from 16 applicants. FDA estimates that approximately 10 percent of these supplements would be submitted with a claim for categorical exclusion or an EA.
FDA has received approximately 481 claims for categorical exclusion as required under § 25.15(a) and (d) annually and 2 EAs as required under § 25.40(a) and (c) annually. Therefore, FDA estimates that approximately 247 respondents will submit an average of 2 applications for categorical exclusion and 2 respondents will submit an average of 1 EA. Based on information provided by industry, FDA estimates that it takes sponsors and applicants approximately 8 hours to prepare a claim of categorical exclusion and approximately 3,400 hours to prepare an EA for a biological product.
Under 21 CFR 514.1(b)(14), new animal drug applications (NADAs) and abbreviated new animal drug applications (ANADAs); 21 CFR 514.8(a)(1) supplemental NADAs and ANADAs; 21 CFR 511.1(b)(10) investigational new animal drug applications (INADs) and generic investigational new animal drug applications (JINADs), and 21 CFR 571.1(c) food additive petitions must contain a claim for categorical exclusion under § 25.30 or § 25.32 or an EA under § 25.40. Annually, FDA's Center for Veterinary Medicine has received approximately 810 claims for categorical exclusion as required under § 25.15(a) and (d) and 22 EAs as required under § 25.40(a) and (c). Assuming an average of 10 claims per respondent, FDA estimates that approximately 81 respondents will submit an average of 10 claims for categorical exclusion. FDA further estimates that 22 respondents will submit an average of 1 EA. FDA estimates that it takes sponsors/applicants approximately 3 hours to prepare a claim of categorical exclusion and an average of 2,160 hours to prepare an EA.
Under sections 905, 910, and 911 of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 387e, 387j, and 387k), product applications and supplements (PMTAs), SEs, Exemption from SEs, and modified risk tobacco products must contain a claim for categorical exclusion or an EA. FDA's estimates are based on actual report data from fiscal year (FY) 2015 to FY 2017, on average FDA estimated it received approximately 260 premarket review of new tobacco PMTAs from 260 respondents, 3,601 provisional reports intended to demonstrate the substantial equivalence of a new tobacco product (SEs) from 3,601 respondents, 2,375 regular SE reports from 2,375 respondents, 101 exemption from substantial equivalence requirements applications (SE Exemptions) from 101 respondents, and 27 modified risk tobacco product applications (MRTPAs) from 27 respondents. Based on updated data FDA estimates 5,832 EAs from 5,832 respondents as required under § 25.40(a) and (c). A total of 5,832 respondents will submit an average of 1 application for environmental assessment. Part of the information in the EA will be developed while writing other parts of a PMTA, SE, Exemption from SE, or MRTPA. Based on FDA's experience, previous information provided by potential sponsors and knowledge that part of the EA information has already been produced in one of the tobacco product applications, FDA estimates that it takes approximately 80 hours to prepare an EA.
The Estimated Annual Reporting Burden for Human Foods is no longer a part of this information collection. The burden has now been incorporated into OMB control number 0910-0541.
Our estimated burden for the information collection reflects an overall increase of 453,834 hours (currently approved 231,224) and a corresponding increase of 7,108 annual responses (currently approved 15,527). The new estimated totals are 685,058 hours and 22,635 annual responses. We attribute this adjustment to an increase in the number of EA submissions we received since the last extension.
Food and Drug Administration, HHS.
Notice; renewal of advisory committee.
The Food and Drug Administration (FDA) is announcing the renewal of the Pulmonary-Allergy Drugs Advisory Committee by the Commissioner of Food and Drugs (the Commissioner). The Commissioner has determined that it is in the public interest to renew the Pulmonary-Allergy Drugs Advisory Committee for an additional 2 years beyond the charter expiration date. The new charter will be in effect until May 30, 2020.
Authority for the Pulmonary-Allergy Drugs Advisory Committee will expire on May 30, 2020, unless the Commissioner formally determines that renewal is in the public interest.
Cindy Chee, Center for Drug Evaluation and Research, Food and Drug Administration, 10903 New Hampshire Ave., Bldg. 31, Rm. 2417, Silver Spring, MD 20993-0002; 301-796-9001, email:
Pursuant to 41 CFR 102-3.65 and approval by the Department of Health and Human Services pursuant to 45 CFR part 11 and by the General Services Administration, FDA is announcing the renewal of the Pulmonary-Allergy Drugs Advisory Committee (the Committee). The Committee is a discretionary Federal advisory committee established to provide advice to the Commissioner.
The Committee advises the Commissioner or designee in discharging responsibilities as they relate to helping to ensure safe and effective drugs for human use and, as required, any other product for which FDA has regulatory responsibility.
The Committee reviews and evaluates available data concerning the safety and effectiveness of marketed and investigational human drug products for use in the treatment of pulmonary disease and diseases with allergic and/or immunologic mechanisms and makes appropriate recommendations to the Commissioner of Food and Drugs.
The Committee shall consist of a core of 11 voting members including the Chair. Members and the Chair are selected by the Commissioner or designee from among authorities knowledgeable in the fields of pulmonary medicine, allergy, clinical immunology, and epidemiology or statistics. Members will be invited to serve for overlapping terms of up to 4 years. Almost all non-Federal members of this committee serve as Special Government Employees. The core of voting members may include one technically qualified member, selected by the Commissioner or designee, who is identified with consumer interests and is recommended by either a consortium of consumer-oriented organizations or other interested persons. In addition to the voting members, the Committee may include one non-voting member who is identified with industry interests.
Further information regarding the most recent charter and other information can be found at
This document is issued under the Federal Advisory Committee Act (5 U.S.C. app.). For general information related to FDA advisory committees, please check
Food and Drug Administration, HHS.
Notice; correction.
The Food and Drug Administration (FDA) is correcting a notice that appeared in the
Trang Tran, Center for Drug Evaluation and Research, Food and Drug Administration, 10903 New Hampshire Ave., Bldg. 75, Rm. 1671, Silver Spring, MD 20993-0002, 240-402-7945.
In the
1. On page 8090, the entry for ANDA 077483 in the table is removed.
Food and Drug Administration, HHS.
Notice of availability.
The Food and Drug Administration (FDA or Agency) is announcing the availability of a draft document entitled “Requests for Feedback and Meetings for Medical Device Submissions: The Q-Submission Program; Draft Guidance for Industry and Food and Drug Administration Staff.” This draft guidance document provides an overview of the mechanisms available to applicants through which they can request feedback from or a meeting with FDA regarding potential or planned medical device investigational device exemption (IDE) applications, premarket approval (PMA) applications, humanitarian device exemption (HDE) applications, evaluation of automatic class III designations (de novo requests), premarket notification (510(k)) submissions, Clinical Laboratory Improvement Amendments (CLIA) Waiver by Application, Accessory Classification Requests, and certain investigational new drug (IND) applications and biologics license applications (BLAs). This draft guidance, when finalized, is intended to supersede the document entitled “Requests for Feedback on Medical Device Submissions: The Pre-Submission Program and Meetings with Food and Drug Administration Staff” issued on September 29, 2017. This draft guidance is not final nor is it in effect at this time.
Submit either electronic or written comments on the draft guidance by August 6, 2018 to ensure that the Agency considers your comment on this draft guidance before it begins work on the final version of the guidance.
You may submit comments on any guidance at any time as follows:
Submit electronic comments in the following way:
•
• If you want to submit a comment with confidential information that you do not wish to be made available to the public, submit the comment as a written/paper submission and in the manner detailed (see “Written/Paper Submissions” and “Instructions”).
Submit written/paper submissions as follows:
•
• For written/paper comments submitted to the Dockets Management Staff, FDA will post your comment, as well as any attachments, except for information submitted, marked and identified, as confidential, if submitted as detailed in “Instructions.”
• Confidential Submissions—To submit a comment with confidential information that you do not wish to be made publicly available, submit your comments only as a written/paper submission. You should submit two copies total. One copy will include the information you claim to be confidential with a heading or cover note that states “THIS DOCUMENT CONTAINS CONFIDENTIAL INFORMATION.” The Agency will review this copy, including the claimed confidential information, in its consideration of comments. The second copy, which will have the claimed confidential information redacted/blacked out, will be available for public viewing and posted on
You may submit comments on any guidance at any time (see 21 CFR 10.115(g)(5)).
An electronic copy of the guidance document is available for download from the internet. See the
J. Allen Hill, Center for Devices and Radiological Health, Food and Drug Administration, 10903 New Hampshire Ave., Bldg. 66, Rm. 5627, Silver Spring, MD 20993-0002, 301-796-7086; or Stephen Ripley, Center for Biologics Evaluation and Research, Food and Drug Administration, 10903 New Hampshire Ave., Bldg. 71, Rm. 7301, Silver Spring, MD 20993, 240-402-7911.
The pre-IDE program was established in 1995, to provide applicants a mechanism to obtain FDA feedback on future IDE applications prior to their submission. Over time, the pre-IDE program evolved to include feedback on PMA applications, HDE applications, de novo requests, and 510(k) submissions, as well as to address whether a clinical study requires submission of an IDE.
To capture this evolution, the Secretary of Health and Human Services' 2012 Commitment Letter to Congress regarding the Medical Device User Fee Amendments of 2012 (MDUFA III) included FDA's commitment to institute a structured process for managing these interactions, referring to them as “Pre-Submissions.” The Pre-Submission Guidance, published February 18, 2014, implemented the broader Q-Submission (Q-Sub) Program, which includes Pre-Submissions (Pre-Subs), as well as additional opportunities to engage with FDA.
As part of the Medical Device User Fee Amendments of 2017 (MDUFA IV), industry and the Agency agreed to refine the Q-Sub Program with changes related to the scheduling of Pre-Sub meetings and a new performance goal on the timing of FDA feedback on Pre-Subs. This guidance reflects those changes and clarifies other elements of the Q-Sub program.
This draft guidance document provides an overview of the mechanisms available to applicants through which they can request feedback from or a meeting with FDA regarding potential or planned medical device IDE applications, PMA applications, HDE applications, de novo requests, 510(k) Submissions, CLIA Waiver by Application, Accessory Classification Requests, and certain INDs and BLAs.
This draft guidance is being issued consistent with FDA's good guidance practices regulation (21 CFR 10.115). The draft guidance, when finalized, will represent the current thinking of FDA on “Requests for Feedback and Meetings for Medical Device Submissions: The Q-Submission Program; Draft Guidance for Industry and Food and Drug Administration Staff.” It does not establish any rights for any person and is not binding on FDA or the public. You can use an alternative approach if it satisfies the requirements of the applicable statutes and regulations. This guidance is not subject to Executive Order 12866.
Persons interested in obtaining a copy of the draft guidance may do so by downloading an electronic copy from the internet. A search capability for all Center for Devices and Radiological Health guidance documents is available at
This draft guidance also refers to previously approved information collections 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 803 are approved under OMB control number 0910-0437; the collections of information in 21 CFR part 807, subpart E are approved under OMB control number 0910-0120; the collections of information in 21 CFR part 812 are approved under OMB control number 0910-0078; the collections of information in 21 CFR part 814 are approved under OMB control number 0910-0231; and the collections of information for “Request for Feedback on Medical Device Submissions” are approved under OMB control number 0910-0756.
Food and Drug Administration, HHS.
Notice, establishment of a public docket; request for comments.
The Food and Drug Administration (FDA) announces a forthcoming public advisory committee meeting of the Pulmonary-Allergy Drugs Advisory Committee. The general function of the committee is to provide advice and recommendations to FDA on regulatory issues. The meeting will be open to the public. FDA is establishing a docket for public comment on this document.
The meeting will be held on July 25, 2018, from 8 a.m. to 4 p.m.
FDA White Oak Campus, 10903 New Hampshire Ave., Bldg. 31 Conference Center, the Great Room (Rm. 1503), Silver Spring, MD 20993-0002. Answers to commonly asked questions including information regarding special accommodations due to a disability, visitor parking, and transportation may be accessed at:
FDA is establishing a docket for public comment on this meeting. The docket number is FDA-2018-N-1823. The docket will close on July 24, 2018. Submit either electronic or written comments on this public meeting by July 24, 2018. Please note that late, untimely filed comments will not be considered. Electronic comments must be submitted on or before July 24, 2018. The
Comments received on or before July 11, 2018, will be provided to the committee. Comments received after that date will be taken into consideration by FDA.
You may submit comments as follows:
Submit electronic comments in the following way:
•
• If you want to submit a comment with confidential information that you do not wish to be made available to the public, submit the comment as a written/paper submission and in the manner detailed (see “Written/Paper Submissions” and “Instructions”).
Submit written/paper submissions as follows:
•
• For written/paper comments submitted to the Dockets Management Staff, FDA will post your comment, as well as any attachments, except for information submitted, marked and identified, as confidential, if submitted as detailed in “Instructions.”
• Confidential Submissions—To submit a comment with confidential information that you do not wish to be made publicly available, submit your comments only as a written/paper submission. You should submit two copies total. One copy will include the information you claim to be confidential with a heading or cover note that states “THIS DOCUMENT CONTAINS CONFIDENTIAL INFORMATION.” FDA will review this copy, including the claimed confidential information, in its consideration of comments. The second copy, which will have the claimed confidential information redacted/blacked out, will be available for public viewing and posted on
Jennifer Shepherd, Center for Drug Evaluation and Research, Food and Drug Administration, 10903 New Hampshire Ave., Bldg. 31, Rm. 2417, Silver Spring, MD 20993-0002, 301-796-9001, Fax: 301-847-8533, email:
FDA intends to make background material available to the public no later than 2 business days before the meeting. If FDA is unable to post the background material on its website prior to the meeting, the background material will be made publicly available at the location of the advisory committee meeting, and the background material will be posted on FDA's website after the meeting. Background material is available at
Persons attending FDA's advisory committee meetings are advised that FDA is not responsible for providing access to electrical outlets.
For press inquiries, please contact the Office of Media Affairs at
FDA welcomes the attendance of the public at its advisory committee meetings and will make every effort to accommodate persons with disabilities. If you require accommodations due to a disability, please contact Jennifer Shepherd (see
FDA is committed to the orderly conduct of its advisory committee meetings. Please visit our website at
Notice of this meeting is given under the Federal Advisory Committee Act (5 U.S.C. app. 2).
Immediate Office of the Secretary, HHS.
Request for information.
This request for information solicits public comment on a planned initiative of the Office of the Deputy Secretary of HHS to develop a workgroup to facilitate constructive, high-level dialogue between HHS leadership and those focused on innovating and investing in the healthcare industry. HHS seeks comment on how to structure a workgroup, or other form of interaction between the Department and such participants in the healthcare industry, in order to best support communication and understanding between these parties that will spur investment, increase competition, accelerate innovation, and allow capital investment in the healthcare sector to have a more significant impact on the health and wellbeing of Americans. HHS also seeks comment more broadly on opportunities for increased engagement and dialogue between HHS and those focused on innovating and investing in the healthcare industry.
Comments must be submitted within 30 days after the date of publication in the
You may submit comments in one of three ways (please choose only one of the ways listed):
1.
2.
Please allow sufficient time for mailed comments to be received before the close of the comment period.
3.
William Brady, (202) 690-6133.
The healthcare industry is a complex and highly regulated industry, and although significant investment occurs within the industry, innovation and investment in the healthcare industry must increase to produce more significant impact on the health and wellbeing of the American people. Through this effort, the Department intends to provide a forum for HHS leadership to engage in a dialogue with those focused on innovating and investing in the healthcare industry, such as healthcare innovation-focused companies, healthcare startup incubators and accelerators, healthcare investment professionals, healthcare-focused private equity firms, healthcare-focused venture capital firms, and lenders to healthcare investors and innovators. While HHS seeks comment on the structure and focus of the workgroup, as well as other opportunities for engagement, the Department envisions the workgroup as a forum to hear the individual perspectives of attendees and foster new and innovative approaches to tackle the complicated challenges facing the healthcare industry. The Department intends for non-HHS attendees to be diverse across the subsectors of the healthcare industry and the investment and innovation lifecycles, and for HHS attendees to be diverse across the Department in senior leadership positions. Workgroup members will not be asked to provide any reports or collaborative work product. No travel expenses, per diem, or compensation of any type will be provided to attendees.
HHS seeks comment on how to structure the workgroup in order to best support communication and understanding between these parties that will spur investment in the healthcare industry, increase competition, improve innovation, and allow capital investment in the healthcare sector to have a more significant impact on the health and wellbeing of Americans. HHS also seeks comment more broadly on opportunities for increased engagement and dialogue between HHS and those focused on innovating and investing in the healthcare industry. Specifically, HHS seeks comments addressing the following topics:
1. Specific areas of inquiry or focus for the workgroup. Should the workgroup review recent developments in health innovation and investing? Should the workgroup examine perceived barriers to innovation and competition in the healthcare industry? Should the workgroup encourage outside parties to provide HHS with information about how they are affected by HHS programs or regulatory requirements? Should the workgroup provide a forum for attendees to share their perspectives as to how the Department may improve relevant regulations, guidance, or other documents? Should the workgroup examine ways to encourage private sector investment to help combat health crises? What other areas of focus would best help the Department engage with diverse subsectors of the healthcare
2. How the workgroup should be convened and structured, including what subsectors of the healthcare economy should be invited to participate, and the most effective size. How should the agency structure meetings or other engagements in order to best facilitate the exchange of information and the presentation of attendees' individual perspectives? The Department seeks comment on how suitable attendees should be identified and selected to attend and engage in an exchange of ideas about the Department's goals of increasing innovation and investment in the healthcare sector.
3. HHS also seeks comment more broadly on opportunities for increased engagement and dialogue between HHS and those focused on innovating and investing in the healthcare industry, including alternatives to the workgroup structure discussed in this request for information. The Department is interested in comments that propose alternatives for developing a durable and consistent approach to increase innovation and investment in the healthcare sector to improve the public health and wellbeing of Americans.
This is a request for information only. Respondents are encouraged to provide complete but concise responses to any or all of the questions outlined above. This request for information is issued solely for information and planning purposes; it does not constitute a notice of proposed rulemaking or request for proposals, applications, proposal abstracts, or quotations, nor does it suggest that the Department will undertake any particular action in response to comments. This request for information does not commit the United States Government (“Government”) to contract for any supplies or services or make a grant award. Further, HHS is not seeking proposals through this request for information and will not accept unsolicited proposals. Respondents are advised that the Government will not pay for any information or administrative costs incurred in response to this request for information; all costs associated with responding to this request for information will be solely at the interested party's expense. Not responding to this request for information does not preclude participation in any future rulemaking or procurement, if conducted. It is the responsibility of the potential responders to monitor this request for information announcement for additional information pertaining to this request. We also note that HHS will not respond to questions about the policy issues raised in this request for information. HHS may or may not choose to contact individual responders. Such communications would only serve to further clarify written responses. Contractor support personnel may be used to review the responses submitted under this request for information. Responses to this notice are not offers and cannot be accepted by the Government to form a binding contract or issue a grant. Information obtained in response to this request for information may be used by the Government for program planning on a non-attribution basis. Respondents should not include any information that might be considered proprietary or confidential. This request for information should not be construed as a commitment or authorization to incur cost for which reimbursement would be required or sought. All submissions become Government property and will not be returned. HHS may publicly post the comments received, or a summary thereof. While responses to this request for information do not bind HHS to any further actions related to the response, all comments may be posted online on
This document does not impose information collection requirements; that is, reporting, recordkeeping or third-party disclosure requirements. This request for information constitutes a general solicitation of comments. In accordance with the implementing regulations of the Paperwork Reduction Act of 1995 (PRA) at 5 CFR 1320.3(h)(4), information subject to the PRA does not generally include “facts or opinions submitted in response to general solicitations of comments from the public, published in the
42 U.S.C. 3501.
Pursuant to section 10(d) of the Federal Advisory Committee Act, as amended, 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.
National Institutes of Health, Department of Health and Human Services.
Notice.
The National Cancer Institute, an institute of the National Institutes of Health, Department of Health and Human Services, is contemplating the grant of an Exclusive Patent License to practice the inventions embodied in the Patents and Patent Applications listed in the
Only written comments and/or complete applications for a license which are received by the National Cancer Institute's Technology Transfer Center on or before June 22, 2018 will be considered.
Requests for copies of the patent application, inquiries, and comments relating to the contemplated an Exclusive Patent License should be directed to: David A. Lambertson, Ph.D., Senior Technology Transfer Manager, NCI Technology Transfer Center, 9609 Medical Center Drive, RM 1E530 MSC 9702, Bethesda, MD 20892-9702 (for business mail), Rockville, MD 20850-9702 Telephone: (240)-276-5530; Facsimile: (240)-276-5504 Email:
The following represents the intellectual property to be licensed under the prospective agreement:
U.S. Patent Application 62/255,255 (HHS reference E-010-2016-0-US-01), U.S. Patent Application 62/257,493 (HHS reference E-010-2016-1-US-01), and PCT Patent Application PCT/US2016/061320 (HHS reference E-010-2016-2-PCT-01);
U.S. Patent Application 61/887,418 (HHS reference E-771-2013-0-US-01), U.S. Patent Application 61/908,464 (HHS reference E-771-2013-1-US-01), U.S. Patent Application 61/982,051 (HHS reference E-771-2013-2-US-01), U.S. Patent Application 61/052,665 (HHS reference E-771-2013-3-US-01), PCT Application PCT/US2014/058941 (HHS reference E-771-2013-4-PCT-01), U.S. Patent 9,388,222 (HHS reference E-771-2013-4-US-02), Australian Patent Application 2014329437 (HHS reference E-771-2013-4-AU-08), Canadian Patent Application 2926215 (HHS reference E-771-2013-4-CA-09), Chinese Patent Application 201480062185.7 (HHS Reference E-771-2013-4-CN-10), European Patent Application 14789449.7 (HHS reference E-771-2013-4-EP-11), Indian Patent Application 201647015226 (HHS reference E-771-2013-4-IN-12), Russian Patent Application 2016114406 (HHS reference E-771-2013-4-RU-13), Japanese Patent Application (HHS reference E-771-2013-4-JP-14), and U.S. Patent Application 15/191,392 (HHS reference E-771-2013-4-US-15);
U.S. Patent Application 61/535,668 (HHS reference E-263-2011-0-US-01), PCT Application PCT/US2012/055034 (HHS reference E-263-2011-0-PCT-02), Australian Patent 2012308591 (HHS reference E-263-2011-0-AU-03), Canadian Patent Application 2846608 (HHS reference E-263-2011-0-CA-04), European Patent 2755993 (HHS reference E-263-2011-0-EP-05), U.S. Patent 9,206,240 (HHS reference E-263-2011-0-US-06), Hong Kong Patent Application 14111650.2 (HHS reference E-263-2011-0-HK-07), U.S. Patent 9,657,066 (HHS reference E-263-2011-0-US-08), U.S. Patent Application 15/488,898 (HHS reference E-263-2011-0-US-09) and European Patent Application 14/927,645 (HHS reference E-263-2011-0-EP-18);
U.S. Patent Application 61/495,085 (HHS reference E-174-2011-0-US-01), PCT Application PCT/US2012/041234 (HHS reference E-174-2011-0-PCT-02), Australian Patent 2012268013 (HHS reference E-174-2011-0-AU-03), Brazilian Patent Application 112013031262-9 (HHS reference E-174-2011-0-BR-04), Canadian Patent Application 2838013 (HHS reference E-174-2011-0-CA-05), Chinese Patent Application 201280039071.1 (HHS reference E-174-2011-0-CN-06), European Patent 2718308 (HHS reference E-174-2011-0-EP-07) as validated in Germany, Spain, France, the United Kingdom, and Italy, Hong Kong Patent Application 14105911.9 (HHS reference E-174-2011-0-HK-08), Japanese Patent 6100764 (HHS reference E-174-2011-0-JP-09), South Korean Patent Application 2013-7032402 (HHS reference E-174-2011-0-KR-10), Mexican Patent Application MX/a/2013/014388 (HHS reference E-174-2011-0-MX-11), Russian Patent 2627216 (HHS reference E-174-2011-0-RU-12), U.S. Patent 9,346,859 (HHS reference E-174-2011-0-US-13), Hong Kong Patent Application 14106689.7 (HHS reference E-174-2011-0-HK-14), U.S. Patent 9,765,123 (HHS reference E-174-2011-0-US-15), Australian Patent Application 2017200541 (HHS reference E-174-2011-0-AU-16), European Patent Application 17163568.3 (HHS reference E-174-2011-0-EP-17), Japanese Patent Application 2017-031283 (HHS reference E-174-2011-0-JP-18), and U.S. Patent Application 15/693,705 (HHS reference E-174-2011/0-US-24);
U.S. Patent Application 61/241,620 (HHS reference E-269-2009-0-US-01), PCT Application PCT/US2010/048504 (HHS reference E-269-2009-0-PCT-02), Australian Patent 2010292069 (HHS reference E-269-2009-0-AU-03), Canadian Patent 2773665 (HHS reference E-269-2009-0-CA-04), Chinese Patent 201080049559.3 (HHS reference E-269-2009-0-CN-05), European Patent 2475398 (HHS reference E-269-2009-0-EP-06), as validated in France, Germany, Italy, Spain and the United Kingdom, Indian Patent Application 3197/CHENP/2012 (HHS reference E-269-2009-0-IN-07), Japanese Patent 5795765 (HHS reference E-269-2009-0-JP-08), Russian Patent Application 2012114005 (HHS reference E-269-2009-0-RU-09), and U.S. Patent 8,936,792 (HHS reference E-269-2009-0-US-10);
U.S. Patent Application 60/969,929 (HHS reference E-292-2007-0-US-01), PCT Application PCT/US2008/075296 (HHS reference E-292-2007-0-PCT-02), Australian Patent 2008296194 (HHS reference E-292-2007-0-AU-03), Canadian Patent 2698357 (HHS reference E-292-2007-0-CA-04), European Patent 2197903 (HHS reference E-292-2007-0-EP-05) as validated in Austria, Belgium, Bulgaria, Switzerland, Cyprus, Germany, Denmark, Estonia, Spain, Finland, France, the United Kingdom, Greece, Croatia, Hungary, Ireland, Italy, Lithuania, Luxembourg, Latvia, Monaco, Malta, the Netherlands, Norway, Poland, Portugal, Romania, Slovenia, Slovakia, and Turkey, U.S. Patent 8,871,906 (HHS reference E-292-2007-0-US-06), European Patent 2570425 (HHS reference E-292-2007-0-EP-07) as validated in France, Germany, the United Kingdom, Italy and Spain, and Hong Kong Patent Application 13106628.2 (HHS reference E-292-2007-0-HK-08);
U.S. Patent Application 60/703,798 (HHS reference E-262-2005-0-US-01), PCT Application PCT/US2006/028986 (HHS reference E-262-2005-0-PCT-02), Australian Patent 2006275865 (HHS reference E-262-2005-0-AU-03), Canadian Patent 2616987 (HHS reference E-262-2005-0-CA-04), European Patent 1910407 (HHS reference E-262-2005-0-EP-05) as validated in Switzerland, Germany, Spain, France, the United Kingdom, and Italy, U.S. Patent 8,907,060 (HHS reference E-262-2005-0-US-06), European Patent 2311854 (HHS reference E-262-2005-0-EP-07) as validated in Switzerland, Germany, Spain, France, the United Kingdom, and Italy, European Patent 2332970 (HHS reference E-262-2005-0-EP-08) as validated in Germany, Spain, France, the United Kingdom, and Italy, Australian Patent 2012216642 (HHS reference E-262-2005-0-AU-15), Australian Patent 2014208269 (HHS reference E-262-2005-0-AU-22), European Patent Application 15191388.6 (HHS reference E-262-2005-0-EP-28), European Patent 3006457 (HHS reference E-262-2005/0-EP-29) as validated in Austria, Belgium, Germany, Spain, France, the United Kingdom, Ireland, Italy, the Netherlands, and Poland, European Patent 3006458 (HHS reference E-262-2005-0-EP-30) as validated in Austria, Belgium, Germany, Spain, France, the United Kingdom, Ireland, Italy, the Netherlands, and Poland, Australian Patent 2016202754 (HHS reference E-262-2005-0-AU-31), and Canadian Patent Application 2941466 (HHS reference E-262-2005/0-CA-32);
With respect to persons who have an obligation to assign their right, title and interest to the Government of the United States of America, the patent rights in these inventions have been assigned to the Government of the United States of America.
The prospective exclusive license territory may be worldwide and the field of use may be limited to the following:
“The development and commercialization of a monospecific BCMA-targeted immunotoxin, whereby the immunotoxin is comprised of:
(1) the complementary determining region (CDR) sequences of either
i. the anti-BCMA antibody known as BM24; or
ii. the anti-BCMA antibody known as BM306; and
(2) a
The E-010-2016 technology discloses antibodies that recognize the BCMA (B Cell Maturation Antigen) protein. BCMA is expressed on the cell surface of several forms of cancer, most notably multiple myeloma. Although these BCMA antibodies can potentially be used in many therapeutic formats (
The E-263-2011-0, E-174-2011-0, E-269-2009-0, E-292-2007, E-262-2005-0 and E-771-2013-0-5 technologies (
The development of a new therapeutic targeting BCMA will benefit public health by offering up a treatment for these cancers in instances when conventional first line therapies are ineffective.
This notice is made in accordance with 35 U.S.C. 209 and 37 CFR part 404. The prospective exclusive license will be royalty bearing, and the prospective exclusive license may be granted unless within fifteen (15) days from the date of this published notice, the National Cancer Institute receives written evidence and argument that establishes that the grant of the license would not be consistent with the requirements of 35 U.S.C. 209 and 37 CFR part 404.
In response to this Notice, the public may file comments or objections. Comments and objections, other than those in the form of a completed license application, will not be treated confidentially, and may be made publicly available.
License applications submitted in response to this Notice will be presumed to contain business confidential information and any release of information in these license applications will be made only as required and upon a request under the Freedom of Information Act, 5 U.S.C. 552.
Pursuant to section 10(d) of the Federal Advisory Committee Act, as amended, 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.
This notice is being published less than 15 days prior to the meeting due to the timing limitations imposed by the review and funding cycle.
Pursuant to section 10(d) of the Federal Advisory Committee Act, as amended, 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 contract proposals and the discussions could disclose confidential trade secrets or commercial property such as patentable material, and personal information concerning individuals associated with the contract proposals, the disclosure of which would constitute a clearly unwarranted invasion of personal privacy.
This notice is being published less than 15 days prior to the meeting due to the timing limitations imposed by the review and funding cycle.
National Institutes of Health, HHS.
Notice.
With the successful completion of the 2016 Pill Image Recognition Challenge, the National Library of Medicine (NLM) gratefully acknowledges the pharmaceutical manufacturers, re-packagers, wholesalers, and retail and institutional pharmacies that submitted prescription drug products for imaging as part of its Computational Photography Project for Pill Identification (C3PI). Effective immediately, the NLM is concluding its collection of digital imagery of C3PI oral solid dosage formulations (OSDFs), discontinuing the program, and is no longer accepting prescription drug products for photography.
Any question regarding C3PI and its discontinuation should be sent to: Dr. Terry Yoo at
C3PI developed information infrastructure and computational tools for identifying pills from digital photographs and associated data. C3PI issued a Pill Image Recognition (PIR) computer vision challenge in January 2016, seeking software solutions for the content-based information retrieval of drug information from images submitted as queries. NLM quantitatively evaluated the resulting entries and awarded prizes to the winners. The findings from the PIR challenge were published in October 2016. See
NLM is ending the project. No future prescription drug products will be accepted. Digital images will not be obtained of drug products that may have been submitted but not photographed as of the termination of this project.
Pursuant to section 10(d) of the Federal Advisory Committee Act, as amended, 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, 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
Coast Guard, DHS.
Notification of issuance of a certificate of alternative compliance.
The Coast Guard announces that the Chief, Prevention Division, Thirteenth District has issued a certificate of alternative compliance from the International Regulations for Preventing Collisions at Sea, 1972 (72 COLREGS), for the M/V SAMANTHA S (O.N. 1283014). We are issuing this notice because its publication is required by statute. Due to the construction and placement of the towing gear, deck equipment and required lights, the M/V SAMANTHA S cannot fully comply with the light, shape, or sound signal provisions of the 72 COLREGS without interfering with the vessel's design and construction. This notification of issuance of a certificate of alternative compliance promotes the Coast Guard's marine safety mission.
The Certificate of Alternative Compliance was issued on May 31, 2018.
For information or questions about this notice call or email LT B. Luke Woods, Thirteenth District, U.S. Coast Guard; telephone 206-220-7232, email
The United States is signatory to the International Maritime Organization's International Regulations for Preventing Collisions at Sea, 1972 (72 COLREGS), as amended. The special construction or purpose of some vessels makes them unable to comply with the light, shape, or sound signal provisions of the 72 COLREGS. Under statutory law
The Chief, Prevention Division, of the Thirteenth Coast Guard District, U.S. Coast Guard, certifies that the M/V SAMANTHA S (O.N. 1283014) is a vessel of special construction or purpose, and that, with respect to the position of the sternlight, towing light and sidelights, it is not possible to comply fully with the requirements of the provisions enumerated in the 72 COLREGS, without interfering with the normal operation, construction, or design of the vessel. The Chief, Prevention Division, of the Thirteenth Coast Guard District, U.S. Coast Guard further finds and certifies that the sternlight, towing light and sidelights, are in the closest possible compliance with the applicable provisions of the 72 COLREGS.
This notice is issued under authority of 33 U.S.C. 1605(c) and 33 CFR 81.18.
Federal Emergency Management Agency, DHS.
Notice.
New or modified Base (1-percent annual chance) Flood Elevations (BFEs), base flood depths, Special Flood Hazard Area (SFHA) boundaries or zone designations, and/or regulatory floodways (hereinafter referred to as flood hazard determinations) as shown on the indicated Letter of Map Revision (LOMR) for each of the communities listed in the table below are finalized. Each LOMR revises the Flood Insurance Rate Maps (FIRMs), and in some cases the Flood Insurance Study (FIS) reports, currently in effect for the listed communities. The flood hazard determinations modified by each LOMR will be used to calculate flood insurance premium rates for new buildings and their contents.
Each LOMR was finalized as in the table below.
Each LOMR is available for inspection at both the respective Community Map Repository address listed in the table below and online through the FEMA Map Service Center at
Rick Sacbibit, Chief, Engineering Services Branch, Federal Insurance and Mitigation Administration, FEMA, 400 C Street SW, Washington, DC 20472, (202) 646-7659, or (email)
The Federal Emergency Management Agency (FEMA) makes the final flood hazard determinations as shown in the LOMRs for each community listed in the table below. Notice of these modified flood hazard determinations has been published in newspapers of local circulation and 90 days have elapsed since that publication. The Deputy Associate Administrator for Insurance and Mitigation has resolved any appeals resulting from this notification.
The modified flood hazard determinations are made pursuant to section 206 of the Flood Disaster Protection Act of 1973, 42 U.S.C. 4105, and are in accordance with the National Flood Insurance Act of 1968, 42 U.S.C. 4001
For rating purposes, the currently effective community number is shown and must be used for all new policies and renewals.
The new or modified flood hazard information is the basis for the floodplain management measures that the community is required either to adopt or to show evidence of being already in effect in order to remain qualified for participation in the National Flood Insurance Program (NFIP).
This new or modified flood hazard information, together with the floodplain management criteria required by 44 CFR 60.3, are the minimum that are required. They should not be construed to mean that the community must change any existing ordinances that are more stringent in their floodplain management requirements. The community may at any time enact stricter requirements of its own or pursuant to policies established by other Federal, State, or regional entities.
These new or modified flood hazard determinations are used to meet the floodplain management requirements of the NFIP and also are used to calculate the appropriate flood insurance premium rates for new buildings, and for the contents in those buildings. The changes in flood hazard determinations are in accordance with 44 CFR 65.4.
Interested lessees and owners of real property are encouraged to review the final flood hazard information available at the address cited below for each community or online through the FEMA Map Service Center at
Federal Emergency Management Agency, DHS.
Notice.
Comments are requested on proposed flood hazard determinations, which may include additions or modifications of any Base Flood Elevation (BFE), base flood depth, Special Flood Hazard Area (SFHA) boundary or zone designation, or regulatory floodway on the Flood Insurance Rate Maps (FIRMs), and where applicable, in the supporting Flood Insurance Study (FIS) reports for the communities listed in the table below. The purpose of this notice is to seek general information and comment regarding the preliminary FIRM, and where applicable, the FIS report that the Federal Emergency Management Agency (FEMA) has provided to the affected communities. The FIRM and FIS report are the basis of the floodplain management measures that the community is required either to adopt or to show evidence of having in effect in order to qualify or remain qualified for participation in the National Flood Insurance Program (NFIP). In addition, the FIRM and FIS report, once effective, will be used by insurance agents and others to calculate appropriate flood insurance premium rates for new buildings and the contents of those buildings.
Comments are to be submitted on or before September 5, 2018.
The Preliminary FIRM, and where applicable, the FIS report for each community are available for inspection at both the online location
You may submit comments, identified by Docket No. FEMA-B-1828, to Rick Sacbibit, Chief, Engineering Services Branch, Federal Insurance and Mitigation Administration, FEMA, 400 C Street SW, Washington, DC 20472, (202) 646-7659, or (email)
Rick Sacbibit, Chief, Engineering Services Branch, Federal Insurance and Mitigation Administration, FEMA, 400 C Street SW, Washington, DC 20472, (202) 646-7659, or (email)
FEMA proposes to make flood hazard determinations for each community listed below, in accordance with section 110 of the Flood Disaster Protection Act of 1973, 42 U.S.C. 4104, and 44 CFR 67.4(a).
These proposed flood hazard determinations, together with the floodplain management criteria required by 44 CFR 60.3, are the minimum that are required. They should not be construed to mean that the community must change any existing ordinances that are more stringent in their floodplain management requirements. The community may at any time enact stricter requirements of its own or pursuant to policies established by other Federal, State, or regional entities. These flood hazard determinations are used to meet the floodplain management requirements of the NFIP and also are used to calculate the appropriate flood insurance premium rates for new buildings built after the FIRM and FIS report become effective.
The communities affected by the flood hazard determinations are provided in the tables below. Any request for reconsideration of the revised flood hazard information shown on the Preliminary FIRM and FIS report that satisfies the data requirements outlined in 44 CFR 67.6(b) is considered an appeal. Comments unrelated to the flood hazard determinations also will be considered before the FIRM and FIS report become effective.
Use of a Scientific Resolution Panel (SRP) is available to communities in support of the appeal resolution process. SRPs are independent panels of experts in hydrology, hydraulics, and other pertinent sciences established to review conflicting scientific and technical data and provide recommendations for resolution. Use of the SRP only may be exercised after FEMA and local communities have been engaged in a collaborative consultation process for at least 60 days without a mutually acceptable resolution of an appeal. Additional information regarding the SRP process can be found online at
The watersheds and/or communities affected are listed in the tables below. The Preliminary FIRM, and where applicable, FIS report for each community are available for inspection at both the online location
Federal Emergency Management Agency, DHS.
Notice.
This notice amends the notice of a major disaster declaration for the State of Ohio (FEMA-4360-DR), dated April 17, 2018, and related determinations.
This amendment was issued May 25, 2018.
Dean Webster, Office of Response and Recovery, Federal Emergency
The notice of a major disaster declaration for the State of Ohio is hereby amended to include the following areas among those areas determined to have been adversely affected by the event declared a major disaster by the President in his declaration of April 17, 2018.
Coshocton, Harrison, Jefferson, and Morgan Counties for Public Assistance.
Office of the Chief Procurement Officer, Department of Homeland Security (DHS).
30-Day Notice and request for comments; Extension of a Currently Approved Collection, 1600-0004.
The DHS Office of the Chief Procurement Officer will submit the following Information Collection Request (ICR) to the Office of Management and Budget (OMB) for review and clearance in accordance with the Paperwork Reduction Act of 1995. The information being collected will be obtained from contractors as part of their submissions whenever they file a bid protest with DHS. The information will be used by DHS officials in deciding how the protest should be resolved. Failure to collect this information would result in delayed resolution of protests. DHS previously published this ICR in the
Comments are encouraged and will be accepted until July 9, 2018. This process is conducted in accordance with 5 CFR 1320.1.
Interested persons are invited to submit written comments on the proposed information collection to the Office of Information and Regulatory Affairs, Office of Management and Budget. Comments should be addressed to OMB Desk Officer, Department of Homeland Security and sent via electronic mail to
The Federal Acquisition Regulation (FAR) and 48 CFR Chapter 1 provide general procedures on handling protests submitted by contractors to Federal agencies. FAR Part 33.103, Protests to the agency, prescribes policies and procedures for filing protests and for processing contract disputes and appeals. While the FAR prescribes the procedures to be followed for protests to the agency, it allows agencies to determine the method of receipt. DHS will utilize electronic mediums (email or facsimile) for collection of information and will not prescribe a format or require more information than what is already required in the FAR. If DHS determines there is a need to collect additional information outside of what is required in the FAR, DHS will submit a request to OMB for approval.
The information being collected will be obtained from contractors as part of their submissions whenever they file a bid protest with DHS. The information will be used by DHS officials in deciding how the protest should be resolved. Failure to collect this information would result in delayed resolution of protests.
Agency protest information is contained in each individual solicitation document, and provides the specified contracting officer's name, email, and mailing address that the contractors would use to submit its response. The FAR does not specify the format in which the contractor should submit protest information. However, most contractors use computers to prepare protest materials and submit time sensitive responses electronically (email or facsimile) to the specified Government point of contact. Since the responses must meet specific timeframes, a centralized mailbox or website would not be a practical method of submission. Submission of protest information through contracting officers' email or through facsimile are the best methods to use to document receipt of protest information, and are the methods most commonly used in the Government protest process.
DHS/ALL/PIA-006 General Contact Lists covers the basic contact information that must be collected for DHS to address these protests. The other information collected will typically pertain to the contract itself, and not individuals. However, all information for this information collection is submitted voluntarily. Technically, because this information is not retrieved by personal identifier, no SORN is required. However, DHS/ALL-021 DHS Contractors and Consultants provides coverage for the collection of records on DHS contractors and consultants, to include resume and qualifying employment information. There is no assurance of confidentiality provided to the respondents.
The burden estimates are based upon reports of protest activities submitted to the Government Accountability Office (GAO) or the Court of Federal Claims in Fiscal Year 2016. No program changes occurred, however, the burden was adjusted to reflect an agency adjustment increase of 4 respondents within DHS for Fiscal Year 2016, as well as an increase in the average hourly wage rate.
This is an Extension of a Currently Approved Collection, 1600-0004. DHS previously published this ICR in the
1. 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;
2. 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;
3. Enhance the quality, utility, and clarity of the information to be collected; and
4. 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,
United States International Trade Commission.
June 15, 2018 at 11:00 a.m.
Room 101, 500 E Street SW, Washington, DC 20436, Telephone: (202) 205-2000.
Open to the public.
In accordance with Commission policy, subject matter listed above, not disposed of at the scheduled meeting, may be carried over to the agenda of the following meeting.
By order of the Commission.
Bureau of Alcohol, Tobacco, Firearms and Explosives, Department of Justice.
30-Day notice.
The Department of Justice (DOJ), Bureau of Alcohol, Tobacco, Firearms and Explosives (ATF), will submit 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 proposed information collection was previously published in the [
Comments are encouraged and will be accepted for an additional 30 days until July 9, 2018.
If you have additional comments, particularly with respect to the estimated public burden or associated response time, have suggestions, need a copy of the proposed information collection instrument with instructions, or desire any other additional information, please contact Shawn Stevens, Federal Explosives Licensing Center, either by mail at 244 Needy Road, Martinsburg, WV 25405, by email
Written comments and suggestions from the public and affected agencies concerning the proposed collection of information are encouraged. Your comments should address one or more of the following four points:
Overview of this information collection:
(1)
(2)
(3)
(4)
(5)
(6)
If additional information is required contact: Melody Braswell, Department Clearance Officer, United States Department of Justice, Justice Management Division, Policy and Planning Staff, Two Constitution
Bureau of Alcohol, Tobacco, Firearms and Explosives, Department of Justice.
30-day notice.
The Department of Justice (DOJ), Bureau of Alcohol, Tobacco, Firearms and Explosives (ATF), will submit 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 proposed information collection was previously published in the
Comments are encouraged and will be accepted for an additional 30 days until July 9, 2018.
If you have additional comments, particularly with respect to the estimated public burden or associated response time, have suggestions, need a copy of the proposed information collection instrument with instructions, or desire any other additional information, please contact L. William Babbie, ATF Firearms & Explosives Industry Division either by mail at 99 New York Avenue NE, Washington, DC 20226, by email at
Written comments and suggestions from the public and affected agencies concerning the proposed collection of information are encouraged. Your comments should address one or more of the following four points:
Overview of this information collection:
(1)
(2)
(3)
(4)
(5)
(6)
(7)
If additional information is required contact: Melody Braswell, Department Clearance Officer, United States Department of Justice, Justice Management Division, Policy and Planning Staff, Two Constitution Square, 145 N Street NE, 3E.405A, Washington, DC 20530.
Notice is hereby given that, on May 16, 2018, pursuant to Section 6(a) of the National Cooperative Research and Production Act of 1993, 15 U.S.C. 4301
Also, Behavior Tech Computer Corp., Fremont, CA; and Rainbo Records Manufacturing Corporation, Canoga Park, CA, have withdrawn as parties to this venture.
No other changes have been made in either the membership or planned activity of the group research project. Membership in this group research project remains open, and DVD CCA intends to file additional written notifications disclosing all changes in membership.
On April 11, 2001, DVD CCA filed its original notification pursuant to Section 6(a) of the Act. The Department of Justice published a notice in the
The last notification was filed with the Department on February 15, 2018. A notice was published in the
Notice is hereby given that, on May 1, 2018, pursuant to Section 6(a) of the National Cooperative Research and Production Act of 1993, 15 U.S.C. 4301
Also, Toshiba Corporation, Kanagawa, JAPAN, has withdrawn as a party to this venture.
No other changes have been made in either the membership or planned activity of the group research project. Membership in this group research project remains open, and HSA Foundation intends to file additional written notifications disclosing all changes in membership.
On August 31, 2012, HSA Foundation filed its original notification pursuant to Section 6(a) of the Act. The Department of Justice published a notice in the
The last notification was filed with the Department on February 13, 2018. A notice was published in the
60-Day Notice.
The Department of Justice (DOJ), Criminal Division, will be submitting 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 proposed information collection is published to obtain comments from the public and affected agencies. Comments are encouraged and will be accepted until August 6, 2018.
If you have comments especially on the estimated public burden or associated response time, suggestions, or need a copy of the proposed information collection instrument with instructions or additional information, please contact Michelle Hill, Counsel to the Director, U.S. Department of Justice, 950 Pennsylvania Avenue NW, Criminal Division, Office of Enforcement Operations, Gambling Device Registration Program, JCK Building, Washington, DC 20530-0001. (telephone: 202-514-7049)
Written comments and suggestions from the public and affected agencies concerning the proposed collection of information are encouraged. Your comments should address one or more of the following four points:
Overview of this information collection:
(1) Type of Information Collection: Revision of a currently approved collection.
(2) Title of the Form/Collection: Request for Registration Under the Gambling Devices Act of 1962.
(3) Agency form number, if any, and the applicable component of the Department of Justice sponsoring the collection: Form Number: DOJ\CRM\OEO\GDR-1. Sponsoring component: Criminal Division, Department of Justice.
(4) Affected public who will be asked or required to respond, as well as a brief abstract: Primary: Business or other for-profit. Other: Not-for-profit institutions, individuals or households, and State, Local or Tribal Government. The form can be used by any entity required to register under the Gambling Devices Act of 1962 (15 U.S.C. 1171-1178).
(5) An estimate of the total number of respondents and the amount of time estimated for an average respondent to respond: It is estimated that 7,800 respondents will complete each form within approximately 5 minutes.
(6) An estimate of the total public burden (in hours) associated with the collection: There are an estimated 650 total annual burden hours associated with this collection.
If additional information is required contact: Melody Braswell, Department Clearance Officer, United States Department of Justice, Justice Management Division, Policy and Planning Staff, Two Constitution Square, 145 N Street NE, 3E.405A, Washington, DC 20530.
National Aeronautics and Space Administration.
Notice of intent to grant partially exclusive patent license.
The National Aeronautics and Space Administration (NASA) hereby gives notice of its intent to grant a partially exclusive patent license in the United States to practice the inventions described and claimed in U.S. Patent Number 7,075,295 B2 titled “Magnetic Field Response Sensor for Conductive Media,” NASA Case Number LAR-16571-1; U.S. Patent Number 7,589,525 B2 titled “Magnetic Field Response Sensor for Conductive Media,” NASA Case Number LAR-16571-2; U.S. Patent No. 7,759,932 B2 titled “Magnetic Field Response for Conductive Media,” NASA Case Number LAR-16571-3; U.S. Patent No. 7,086,593 B2 titled “Magnetic Field Response Measurement Acquisition System,” NASA Case Number LAR-16908-1; U.S. Patent No. 7,047,807 B2 titled “Flexible Framework for Capacitive Sensing,” NASA Case No. LAR-16974-1; U.S. Patent No. 7,159,774 B2 titled “Magnetic Field Response Measurement Acquisition System,” NASA Case No. LAR-17280-1; U.S. Patent No. 8,430,327 B2 titled “Wireless Sensing System Using Open-Circuit, Electrically-Conductive Spiral-Trace Sensor,” NASA Case No. LAR-17294-1; U.S. Patent No. 8,673,649 B2 titled “Wireless Chemical Sensor and Sensing Method for Use Therewith,” NASA Case No. LAR-17579-1; U.S. Patent No. 9,329,149 B2 titled “Wireless Chemical Sensor and Sensing Method for Use Therewith,” NASA Case No. LAR-17579-2; U.S. Patent No. 9,733,203 B2 titled “Wireless Chemical Sensing Method,” NASA Case No. LAR-17579-3; U.S. Patent No. 8,179,203 B2 titled “Wireless Electrical Device using Open-Circuit Elements Having No Electrical Connections,” NASA Case No. LAR-17711-1; U.S. Patent Application No. 14/193,861 titled “Wireless Temperature Sensor Having No Electrical Connections and Sensing Method for Use Therewith,” NASA Case No. LAR-17747-1-CON; U.S. Patent No. 9,329,153 B2 titled “Method of Mapping Anomalies in Homogenous Material,” NASA Case No. LAR-17848-1; U.S. Patent No. 8,636,407 B2 titled “Wireless Temperature Sensor Having No Electrical Connections and Sensing Method for Use Therewith,” NASA Case No. LAR-18016-1; U.S. Patent Application No. 14/520,785 titled “Multi-Layer Wireless Sensor Construct for Use at Electrically Conductive Material Surface,” NASA Case No. LAR-18399-1; and U.S. Patent Application No. 14/520,863 titled “Antenna for Far Field Transceiving,” NASA Case No. LAR-18400-1, to Doull Site Assessments Ltd., having its principal place of business in Alberta, Canada. The fields of use may be limited to emissions detection and quantification, gas and liquid flow rate measurement, compositional analysis, and quantification for hydrocarbons and other substances, including but not limited to H
The prospective partially exclusive license may be granted unless NASA receives written objections, including evidence and argument no later than June 22, 2018 that establish that the grant of the license would not be consistent with the requirements regarding the licensing of federally owned inventions as set forth in the Bayh-Dole Act and implementing regulations. Competing applications completed and received by NASA no later than June 22, 2018 will also be treated as objections to the grant of the contemplated partially exclusive license. Objections submitted in response to this notice will not be made available to the public for inspection and, to the extent permitted by law, will not be released under the Freedom of Information Act.
Objections relating to the prospective license may be submitted to Patent Counsel, Office of Chief Counsel, NASA Langley Research Center, MS 30, Hampton, Virginia 23681. Phone (757) 864-3221. Facsimile (757) 864-9190.
Robin W. Edwards, Patent Counsel, Office of Chief Counsel, NASA Langley Research Center, MS 30, Hampton, Virginia 23681. Phone (757) 864-3221. Facsimile (757) 864-9190.
This notice of intent to grant a partially exclusive patent license is issued in accordance with 35 U.S.C. 209(e) and 37 CFR 404.7(a)(1)(i). The patent rights in these inventions have been assigned to the United States of America as represented by the Administrator of the National Aeronautics and Space Administration. The prospective exclusive license will comply with the requirements of 35 U.S.C. 209 and 37 CFR 404.7.
Information about other NASA inventions available for licensing can be found online at
National Aeronautics and Space Administration.
Notice of Intent to Grant Partially Exclusive Patent License.
NASA hereby gives notice of its intent to grant a partially exclusive patent license in the United States to practice the inventions described and claimed in U.S. Patent Application No. 15/014,608 titled “Nuclear Thermionic Avalanche Cells with Thermoelectric (NTAC-TE) Generator in Tandem Model,” NASA Case Number LAR-17981-1; U.S. Patent Application No. 62/513,497 titled “Portable Compact Thermionic Power Cell,” NASA Case Number LAR-18860-P2; U.S. Patent Application No. 15/479,679 titled “Metallic Junction Thermoelectric Generator,” NASA Case Number LAR-18866-1; U.S. Patent Application No. 62/621,930 titled “Selective and Direct Deposition Technique for Streamlined CMOS Processing,” NASA Case Number LAR-18925-P2; U.S. Patent Application No. 62/643,292 titled “Portable Miniaturized Thermionic Power Cell with Multiple Regenerative Layers,” NASA Case No. LAR-18926-P; U.S. Patent Application No. 62/643,303 titled “High Performance Electric Generators Boosted by Nuclear Electorn Avalanche (NEA),” NASA Case No. LAR-19112-P, to Braidy Industries, Inc., having its principal place of business in Ashland, Kentucky. The fields of use may be limited to power generators, generation of electricity and/or similar fields of use thereto.
The prospective partially exclusive patent license may be granted unless NASA receives written objections, including evidence and argument, no later than June 22, 2018 that establish that the grant of the license would not be consistent with the requirements regarding the licensing of federally owned inventions as set forth in the Bayh-Dohl Act and implementing regulations. Competing applications completed and received by NASA no later than June 22, 2018 will also be
Objections relating to the prospective license may be submitted to Patent Counsel, Office of Chief Counsel, NASA Langley Research Center, MS 30, Hampton, Virginia 23681. Phone (757) 864-3221. Facsimile (757) 864-9190.
Jonathan B. Soike, Patent Attorney, Office of Chief Counsel, NASA Langley Research Center, MS 30, Hampton, Virginia 23681. Phone (757) 864-7863. Facsimile (757) 864-9190.
This notice of intent to grant a partially exclusive patent license is issued in accordance with 35 U.S.C. 209(e) and 37 CFR 404.7(a)(1)(i). The patent rights in these inventions have been assigned to the United States of America as represented by the Administrator of the National Aeronautics and Space Administration. The prospective partially exclusive patent license will comply with the requirements of 35 U.S.C. 209 and 37 CFR 404.7.
Information about other NASA inventions available for licensing can be found online at
Nuclear Regulatory Commission.
Environmental assessment and finding of no significant impact; issuance.
The U.S. Nuclear Regulatory Commission (NRC) is considering issuing an environmental assessment (EA) and a finding of no significant impact (FONSI) for its review and approval of the decommissioning funding plans (DFPs) submitted by Pacific Gas and Electric Company (PGEC) on December 17, 2012, and December 17, 2015, for the independent spent fuel storage installation (ISFSI) at Diablo Canyon in Avila Beach, California.
The EA and FONSI referenced in this document are available on June 7, 2018.
Please refer to Docket ID NRC-2018-0108 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:
•
•
•
Pamela Longmire, Office of Nuclear Material Safety and Safeguards, U.S. Nuclear Regulatory Commission, Washington, DC 20555-0001; telephone: 301-415-7465, email:
The NRC is considering the approval of the DFPs for the Diablo Canyon ISFSI. PGEC submitted an initial DFP and an updated DFP for NRC review and approval by letters dated December 17, 2012 (ADAMS Accession No. ML12353A315), and December 17, 2015 (ADAMS Accession No. ML15351A502), respectively. The NRC staff has prepared a final EA (ADAMS Accession No. ML18131A047) in support of its review of PGEC's DFPs in accordance with the NRC regulations in part 51 of title 10 of the
The Diablo Canyon ISFSI is located in Avila Beach, California. PGEC is authorized by the NRC, under License No. SNM-2511, to store spent nuclear fuel at the Diablo Canyon ISFSI.
The NRC requires its licensees to plan for the eventual decommissioning of their licensed facilities prior to license termination. On June 17, 2011, the NRC published a final rule in the
The proposed action is the NRC's review and approval of PGEC's DFPs submitted in accordance with §§ 72.30(b) and (c). To approve the DFPs, the NRC will evaluate whether the decommissioning cost estimate adequately estimates the cost to conduct the required ISFSI decommissioning activities prior to license termination,
The proposed action does not require any changes to the ISFSI's licensed routine operations, maintenance activities, or monitoring programs, nor does it require any new construction or land-disturbing activities. The scope of the proposed action concerns only the NRC's review and approval of PGEC's DFPs. The scope of the proposed action does not include, and will not result in, the review and approval of any decontamination or decommissioning activity or license termination for the ISFSI or any other part of Diablo Canyon.
The proposed action provides a means for PGEC to demonstrate that it will have sufficient funding to cover the costs of decommissioning the ISFSI, including the reduction of the residual radioactivity at the ISFSI to the level specified by the applicable NRC license termination regulations concerning release of the property (10 CFR 20.1402 or 10 CFR 20.1403).
The NRC's approval of the DFPs will not change the scope or nature of the operation of the ISFSI and will not authorize any changes to licensed operations or maintenance activities. The NRC's approval of the DFPs will not result in any changes in the types, characteristics, or quantities of radiological or non-radiological effluents released into the environment from the ISFSI, or result in the creation of any solid waste. Moreover, the approval of the DFPs will not authorize any construction activity or facility modification. Therefore, the NRC staff concludes that the approval of PGEC's DFPs is a procedural and administrative action that will not result in any significant impact to the environment.
Section 106 of the National Historic Preservation Act of 1966, as amended (NHPA), requires Federal agencies to consider the effects of their undertakings on historic properties. In accordance with the NHPA implementing regulations at 36 CFR part 800, “Protection of Historic Properties,” the NRC's approval of PGEC's DFPs constitutes a Federal undertaking. The NRC, however, has determined that the approval of the DFPs is a type of undertaking that does not have the potential to cause effects on historic properties, assuming such historic properties were present, because the NRC's approval of PGEC's DFPs will not authorize or result in changes to licensed operations or maintenance activities, or changes in the types, characteristics, or quantities of radiological or non-radiological effluents released into the environment from the ISFSI, or result in the creation of any solid waste. Therefore, in accordance with 36 CFR 800.3(a)(1), no consultation is required under Section 106 of the NHPA.
Under Section 7 of the Endangered Species Act of 1973, prior to taking a proposed action, a Federal agency must determine whether (i) endangered and threatened species or their critical habitats are known to be in the vicinity of the proposed action and, if so, whether (ii) the proposed Federal action may affect listed species or critical habitats. The NRC has determined that the proposed action will have no effect on any listed species or their critical habitats because the NRC's approval of PGEC's DFPs will not authorize or result in changes to licensed operations or maintenance activities, or changes in the types, characteristics, or quantities of radiological or non-radiological effluents released into the environment from the ISFSI, or result in the creation of any solid waste.
In addition to the proposed action, the NRC evaluated the no-action alternative. The no-action alternative is to deny PGEC's DFPs. A denial of a DFP that meets the criteria of §§ 72.30(b) or (c) does not support the regulatory intent of the 2011 rulemaking. As noted in the EA for the 2011 rulemaking (ADAMS Accession No. ML090500648), not promulgating the 2011 final rule would have increased the likelihood of additional legacy sites. Thus, denying PGEC's DFPs, which the NRC has found to meet the criteria of §§ 72.30(b) and (c), will undermine the licensee's decommissioning planning. On this basis, the NRC has concluded that the no-action alternative is not a viable alternative.
The NRC staff consulted with other agencies and parties regarding the environmental impacts of the proposed action. The NRC provided a draft of its EA to the California Energy Commission (CEC or State) by letter dated April 25, 2016 (ADAMS Accession No. ML17107A273), and gave the CEC 30 days to respond. The State did not respond. The NRC also consulted with the U.S. Fish and Wildlife Service by letter dated April 25, 2016 (ADAMS Accession No. ML16120A606). However, the NRC staff has determined that consultation under Section 7 of the Endangered Species Act of 1973 is not required because the proposed action is administrative/procedural in nature and will not affect listed species or critical habitat (ADAMS Accession No. ML17135A062).
The NRC staff has determined that the proposed action, the review and approval of PGEC's DFPs submitted in accordance with §§ 72.30(b) and (c), will not authorize or result in changes to licensed operations or maintenance activities, or changes in the types, characteristics, or quantities of radiological or non-radiological effluents released into the environment from the ISFSI, or result in the creation of any solid waste. Moreover, the approval of the DFPs will not authorize any construction activity, facility modification, or any other land-disturbing activity. The NRC staff has concluded that the proposed action is a procedural and administrative action and, as such, that the proposed action will not have a significant effect on the quality of the human environment. Therefore, the NRC staff has determined not to prepare an environmental impact statement for the proposed action but will issue this FONSI. In accordance with 10 CFR 51.32(a)(4), the FONSI incorporates the EA by reference.
The following documents, related to this Notice, can be found using any of the methods provided in the following table. Instructions for accessing ADAMS were provided under the
For the Nuclear Regulatory Commission.
Nuclear Regulatory Commission.
Notice of meeting.
The U.S. Nuclear Regulatory Commission (NRC) will convene a teleconference meeting of the Advisory Committee on the Medical Uses of Isotopes (ACMUI) on July 16, 2018, to discuss the draft report of the ACMUI Subcommittee on Training and Experience Requirements for All Modalities. This report will include the subcommittee's comments on the NRC staff's evaluation of the training and experience requirements for different categories of radiopharmaceuticals in Title 10 of the
The teleconference meeting will be held on Monday, July 16, 2018, 2:00 p.m. to 4:00 p.m. Eastern Time.
Dr. Christopher Palestro, ACMUI Chairman, will preside over the meeting. Dr. Palestro will conduct the meeting in a manner that will facilitate the orderly conduct of business. The following procedures apply to public participation in the meeting:
1. Persons who wish to provide a written statement should submit an electronic copy to Ms. Ayoade at the contact information listed above. All submittals must be received by July 11, 2018, three business days prior to the meeting, and must pertain to the topic on the agenda for the meeting.
2. Questions and comments from members of the public will be permitted during the meetings, at the discretion of the Chairman.
3. The draft transcript and meeting summary will be available on the ACMUI's website
This meeting will be held in accordance with the Atomic Energy Act of 1954, as amended (primarily Section 161a); the Federal Advisory Committee Act (5 U.S.C. App); and the Commission's regulations in Title 10 of the
For the Nuclear Regulatory Commission.
Nuclear Regulatory Commission.
Notice of availability; opportunity for comment.
The U.S. Nuclear Regulatory Commission (NRC) is soliciting public comments on a draft letter to the Nuclear Energy Institute (NEI) clarifying the regulatory paths for the use of lead test assemblies (LTAs). This draft letter would finalize the NRC staff's views on the preliminary positions regarding LTAs provided in a letter to NEI dated June 29, 2017. The NRC does not currently have consolidated regulatory guidance regarding the use of LTAs. Therefore, the NRC has drafted this letter to clarify its positions regarding the use of LTAs. These positions would affect light-water reactor licensees who wish to irradiate LTAs.
Submit comments by June 27, 2018. Comments received after this date will be considered if it is practical to do so, but the Commission is able to ensure consideration only for comments received before this date.
You may submit comments by any of the following methods:
• Federal Rulemaking website: Go to
•
For additional direction on obtaining information and submitting comments, see “Obtaining Information and
Jennifer Whitman, Office of Nuclear Reactor Regulation, telephone: 301-415-3253, email:
Please refer to Docket ID NRC-2018-0109 when contacting the NRC about the availability of information for this action. You may obtain publicly-available information related to this action by any of the following methods:
•
•
•
Please include Docket ID NRC-2018-0109 in your comment submission. The NRC cautions you not to include identifying or contact information that you do not want to be publicly disclosed in your comment submission. The NRC will post all comment submissions at
If you are requesting or aggregating comments from other persons for submission to the NRC, then you should inform those persons not to include identifying or contact information that they do not want to be publicly disclosed in their comment submission. Your request should state that the NRC does not routinely edit comment submissions to remove such information before making the comment submissions available to the public or entering the comment into ADAMS.
This draft letter clarifies the NRC staff's interpretation of Standard Technical Specification (STS) 4.2.1, “Fuel Assemblies.” The first part of STS 4.2.1 places limitations on the number of fuel assemblies in the reactor core, the type of fuel that can be used, the cladding material that can be used (
In the past, licensees have taken different approaches when conducting LTA campaigns. Some licensees obtained prior NRC approval by license amendments approving changes to Technical Specification (TS) 4.2.1 or exemptions from § 50.46, “Acceptance criteria for emergency core cooling systems for light-water nuclear power reactors,” of title 10 of the
The draft letter provides clarification on the LTA provision in STS 4.2.1; clarification on the use of approved methods for LTA campaigns; two regulatory paths for LTA campaigns; guidance on the use of NEI 96-07, Revision 1, “Guidelines for 10 CFR 50.59 Implementation,” with regard to LTAs; and a position that an exemption to the requirements in 10 CFR 50.46 is not needed solely for the insertion of LTAs.
An NRC staff member did not agree with some content of the draft letter to the NEI and submitted a non-concurrence on the draft letter. In accordance with the NRC's non-concurrence process, NRC management and staff worked to address the staff member's concerns, and documentation of the non-concurrence is available in ADAMS.
If finalized, the letter would provide additional clarification on previous staff preliminary statements and positions regarding the use of LTAs made in a letter to NEI dated June 29, 2017. Issuance of the letter, if finalized, would not constitute backfitting as defined in 10 CFR 50.109 (the Backfit Rule) and would not otherwise be inconsistent with the issue finality provisions in 10 CFR part 52. The NRC has no current intention to impose the positions described in the draft letter on holders of current operating licenses or combined licenses.
The documents identified in the following table are available to interested persons through one or more of the following methods, as indicated.
The NRC may post materials related to this document, including public comments, on the Federal Rulemaking website at
For the Nuclear Regulatory Commission.
Postal Service
Notice.
The Postal Service gives notice of filing a request with the Postal Regulatory Commission to add a domestic shipping services contract to the list of Negotiated Service Agreements in the Mail Classification Schedule's Competitive Products List.
Elizabeth Reed, 202-268-3179.
The United States Postal Service® hereby gives notice that, pursuant to 39 U.S.C. 3642 and 3632(b)(3), on June 4, 2018, it filed with the Postal Regulatory Commission a
Postal Service
Notice.
The Postal Service gives notice of filing a request with the Postal Regulatory Commission to add a domestic shipping services contract to the list of Negotiated Service Agreements in the Mail Classification Schedule's Competitive Products List.
Elizabeth Reed, 202-268-3179.
The United States Postal Service® hereby gives notice that, pursuant to 39 U.S.C. 3642 and 3632(b)(3), on June 4, 2018, it filed with the Postal Regulatory Commission a
Postal Service
Notice.
The Postal Service gives notice of filing a request with the Postal Regulatory Commission to add a domestic shipping services contract to the list of Negotiated Service Agreements in the Mail Classification Schedule's Competitive Products List.
Elizabeth Reed, 202-268-3179.
The United States Postal Service® hereby gives notice that, pursuant to 39 U.S.C. 3642 and 3632(b)(3), on June 4, 2018, it filed with the Postal Regulatory Commission a
Postal Service
Notice.
The Postal Service gives notice of filing a request with the Postal Regulatory Commission to add a domestic shipping services contract to the list of Negotiated Service Agreements in the Mail Classification Schedule's Competitive Products List.
Elizabeth Reed, 202-268-3179.
The United States Postal Service® hereby gives notice that, pursuant to 39 U.S.C. 3642 and 3632(b)(3), on June 4, 2018, it filed with the Postal Regulatory Commission a
Securities and Exchange Commission (“Commission”).
Notice.
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 sections 6(c) and 17(b) of the Act for an exemption from sections 17(a)(1) and 17(a)(2) of the Act, and under section 12(d)(1)(J) for an exemption from sections 12(d)(1)(A) and 12(d)(1)(B) of the Act. The requested order would permit (a) actively-managed series of certain open-end management investment companies (“Funds”) to issue shares redeemable in large aggregations only (“Creation Units”); (b) secondary market transactions in Fund shares to occur at negotiated market prices rather than at net asset value (“NAV”); (c) certain Funds to pay redemption proceeds, under certain circumstances, more than seven days after the tender of shares for redemption; (d) certain affiliated persons of a Fund to deposit securities into, and receive securities from, the Fund in connection with the purchase and redemption of Creation Units; (e) certain registered management investment companies and unit investment trusts outside of the same group of investment companies as the Funds (“Funds of Funds”) to acquire shares of the Funds; and (f) certain Funds (“Feeder Funds”) to create and redeem Creation Units in-kind in a master-feeder structure.
Secretary, Securities and Exchange Commission, 100 F Street NE, Washington, DC 20549-1090; Applicants: Bibb L. Strench, Esq., Thompson Hine LLP, 1919 M Street NW, Suite 700, Washington, DC 20036-3537; Thomas W. Ulrich, Esq., Sprott Asset Management USA Inc., 1910 Palomar Point Way, Suite 200, Carlsbad, CA 92008.
Courtney S. Thornton, Senior Counsel, at (202) 551-6812, or Andrea Ottomanelli Magovern, Branch Chief, 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 website by searching for the file number, or for an applicant using the Company name box, at
1. Applicants request an order that would allow Funds to operate as actively-managed exchange traded funds (“ETFs”).
2. Each Fund will consist of a portfolio of securities and other assets and investment positions (“Portfolio Instruments”). Each Fund will disclose on its website the identities and quantities of the Portfolio Instruments that will form the basis for the Fund's calculation of NAV at the end of the day.
3. Shares 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 in the application, purchasers will be required to purchase Creation Units by depositing specified instruments (“Deposit Instruments”), and shareholders redeeming their shares will receive specified instruments (“Redemption Instruments”). The Deposit Instruments and the Redemption Instruments will each correspond pro rata to the positions in the Fund's portfolio (including cash positions) except as specified in the application.
4. Because shares will not be individually redeemable, applicants request an exemption from section 5(a)(1) and section 2(a)(32) of the Act that would permit the Funds to register as open-end management investment companies and issue shares that are redeemable in Creation Units only.
5. Applicants also request an exemption from section 22(d) of the Act and rule 22c-1 under the Act as secondary market trading in shares will take place at negotiated prices, not at a current offering price described in a Fund's prospectus, and not at a price based on NAV. Applicants state that (a)
6. With respect to Funds that hold non-U.S. Portfolio Instruments and that effect creations and redemptions of Creation Units in kind, applicants request relief from the requirement imposed by section 22(e) in order to allow such Funds to pay redemption proceeds within fifteen calendar days following the tender of Creation Units for redemption. Applicants assert that the requested relief would not be inconsistent with the spirit and intent of section 22(e) to prevent unreasonable, undisclosed or unforeseen delays in the actual payment of redemption proceeds.
7. Applicants request an exemption to permit Funds of Funds to acquire Fund shares beyond the limits of section 12(d)(1)(A) of the Act; and the Funds, and any principal underwriter for the Funds, and/or any broker or dealer registered under the Exchange Act, to sell shares to Funds of Funds beyond the limits of section 12(d)(1)(B) of the Act. The application's terms and conditions are designed to, among other things, help prevent any potential (i) undue influence over a Fund through control or voting power, or in connection with certain services, transactions, and underwritings, (ii) excessive layering of fees, and (iii) overly complex fund structures, which are the concerns underlying the limits in sections 12(d)(1)(A) and (B) of the Act.
8. Applicants request an exemption from sections 17(a)(1) and 17(a)(2) of the Act to permit a person who is an affiliated person, as defined in section 2(a)(3) of the Act (“Affiliated Person”), or an affiliated person of an Affiliated Person (“Second-Tier Affiliate”), of the Funds, solely by virtue of certain ownership interests, to effectuate purchases and redemptions in-kind. The deposit procedures for in-kind purchases of Creation Units and the redemption procedures for in-kind redemptions of Creation Units will be the same for all purchases and redemptions and Deposit Instruments and Redemption Instruments will be valued in the same manner as those Portfolio Instruments currently held by the Funds. Applicants also seek relief from the prohibitions on affiliated transactions in section 17(a) to permit a Fund 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.
9. Applicants also request relief to permit a Feeder Fund to acquire shares of another registered investment company managed by the Adviser having substantially the same investment objectives as the Feeder Fund (“Master Fund”) beyond the limitations in section 12(d)(1)(A) and permit the Master Fund, and any principal underwriter for the Master Fund, to sell shares of the Master Fund to the Feeder Fund beyond the limitations in section 12(d)(1)(B).
10. Section 6(c) of the Act permits the Commission to exempt any persons or transactions from any provision of the Act if 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 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 provision of section 12(d)(1) if the exemption is consistent with the public interest and the protection of investors. Section 17(b) of the Act authorizes the Commission to grant an order permitting a transaction otherwise prohibited by section 17(a) if it finds that (a) the terms of the proposed transaction are fair and reasonable and do not involve overreaching on the part of any person concerned; (b) the proposed transaction is consistent with the policies of each registered investment company involved; and (c) the proposed transaction is consistent with the general purposes of the Act.
For the Commission, by the Division of Investment Management, under delegated authority.
Pursuant to Section 19(b)(1)
The Exchange proposes to amend the content of the NYSE Best Quote & Trades (“NYSE BQT”) data feed. The proposed rule change is available on the Exchange's website 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,
The Exchange proposes to amend the content of NYSE BQT to include data feeds from the Exchange's affiliate, NYSE National, Inc. (“NYSE National”). The Exchange recently filed a proposed rule change to establish NYSE National market data feeds, including NYSE National BBO (“NYSE National BBO”) and NYSE National Trades (“NYSE National Trades”)
The NYSE BQT
NYSE BBO, NYSE Arca BBO, and NYSE American BBO are existing data feeds that distribute on a realtime basis the same BBO information that NYSE, NYSE Arca, and NYSE American, respectively, report under the Consolidated Quotation (“CQ”) Plan for inclusion in the CQ Plan's consolidated quotation information data stream. NYSE Trades, NYSE Arca Trades, and NYSE American Trades are existing data feeds that distribute on a real-time basis the same last sale information that NYSE, NYSE Arca, and NYSE American, respectively, report under the Consolidated Tape Association (“CTA”) Plan for inclusion in the CTA Plan's consolidated data streams.
The NYSE BQT data feed has three channels: One channel for the last sale data (the “last sale channel”); another channel for the BBO data (the “best quotes channel”); and a third channel for consolidated volume data (the “consolidated volume channel”).
The last sale channel provides an aggregation of the same data that is currently available through NYSE Trades, NYSE Arca Trades, and NYSE American Trades. With this proposed rule change, the last sale channel would also include data available through NYSE National Trades.
The best quotes channel provides the NYSE BQT BBO, which is the best quote from among the NYSE BBO, NYSE Arca BBO, and NYSE MKT BBO based on the following criteria, in order:
•
•
•
With this proposed rule change, the best quotes channel would also include data available through NYSE National BBO.
For each security, the best quotes channel would only include one best bid and one best offer from among the four exchanges. The NYSE BQT BBO would be marked with a market center ID identifying the exchange from which the BBO originated.
The consolidated volume channel carries consolidated volume for all listed equities in a manner consistent with the requirements for redistributing such data as set forth in the securities information processor plans.
As it does today, NYSE BQT would also provide related data elements for NYSE National, such as trade and security status updates (
The Exchange believes that NYSE BQT would continue to provide high-quality, comprehensive last sale and BBO data for the Exchange, NYSE Arca, NYSE American, and now, NYSE National, in a unified view and would respond to subscriber demand for such a product.
With respect to cost, the Exchange will file a separate rule filing to amend the fees for NYSE BQT.
The Exchange will announce the date through a market data notice that the amended NYSE BQT feed that includes NYSE National BBO and NYSE National Trades data would be available and by when a subscriber must subscribe to NYSE National BBO and NYSE National Trades to continue receiving NYSE BQT. This proposed change to NYSE BQT will not be operative until NYSE National has established the NYSE National BBO and NYSE National Trades and related fees via a proposed rule change(s) and NYSE National has re-launched operations.
The Exchange believes that the proposed rule change is consistent with Section 6(b)
The NYSE BQT data feed is a product that relies on the Exchange's receipt of
The Exchange believes that the proposed rule change is consistent with Rule 603 of Regulation NMS,
The Exchange further notes that the existence of alternatives to the Exchange's product, including real-time consolidated data, free delayed consolidated data, and proprietary data from other sources, as well as the continued availability of the Exchange's separate data feeds, ensures that the Exchange is not unreasonably discriminatory because vendors and subscribers can elect these alternatives as their individual business cases warrant. Additionally, the Exchange has taken into consideration its affiliated relationship with NYSE Arca, NYSE American and NYSE National in its design of the NYSE BQT data feed to assure that similarly situated competing vendors would be able to offer a similar product on the same terms as the Exchange, both from the perspective of latency and cost.
The Exchange believes that NYSE BQT offers an alternative to the use of consolidated data products and proprietary data products such as NASDAQ Basic and NLS Plus. NASDAQ Basic, which is offered by The NASDAQ Stock Market, Inc. (“NASDAQ”) provides best bid and offer and last sale information for all U.S. exchange-listed securities (including NYSE and its affiliates) based on liquidity within NASDAQ, as well as trades reported to the FINRA/NASDAQ Trade Reporting Facility (“TRF”), including NASDAQ last sale, NASDAQ BBO, NASDAQ opening and closing prices, and other market status information.
Cboe Global Markets, Inc. (“Cboe”) also offers a market data product that provides a unified view of the aggregated quote and trade updates for all the Cboe equity exchanges.
In addition, this proposal would not permit unfair discrimination because NYSE BQT will continue to be available to all of the Exchange's customers through SFTI and market data vendors on an equivalent basis. In addition, any customer that wished to continue to be able to purchase one or more of the individual underlying data feeds would be able to do so.
In accordance with Section 6(b)(8) of the Act,
With respect to latency, the Exchange, NYSE Arca, NYSE American and NYSE National are located in the same data center in Mahwah, New Jersey. The system creating and supporting the NYSE BQT data feed would need to obtain the eight underlying data feeds from the four exchanges before it could aggregate and consolidate information to create NYSE BQT and then distribute it to end users. Likewise, a competing market data vendor co-located at the Exchange's Mahwah, New Jersey facility could perform the aggregation and consolidation function in the Mahwah facility and redistribute a competing product from that location to similarly situated customers on a level-playing field with respect to the speed that the Exchange could create and redistribute the NYSE BQT data feed.
The Exchange believes that NYSE BQT will continue to promote competition among exchanges by offering an alternative to NASDAQ Basic, NLS Plus and Cboe Equites One Feed.
No written comments were solicited or received with respect to the proposed rule change.
Because the proposed rule change does not (i) significantly affect the protection of investors or the public interest; (ii) impose any significant burden on competition; and (iii) become operative for 30 days from the date on which it was filed, or such shorter time as the Commission may designate, it has become effective pursuant to Section 19(b)(3)(A) of the Act
A proposed rule change filed pursuant to Rule 19b-4(f)(6) under 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 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 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.
Notice is hereby given that, pursuant to the Paperwork Reduction Act of 1995 (44 U.S.C. 350l
Rule 17f-2 (17 CFR 270.17f-2), entitled “Custody of Investments by Registered Management Investment Company,” was adopted in 1940 under section 17(f) of the Investment Company Act of 1940 (15 U.S.C. 80a-17(f)) (the “Act”), and was last amended materially in 1947. Rule 17f-2 establishes safeguards for arrangements in which a registered management investment company (“fund”) is deemed to maintain custody of its own assets, such as when the fund maintains its assets in a facility that provides safekeeping but not custodial services.
Rule 17f-2's requirement that directors designate access persons is intended to ensure that directors evaluate the trustworthiness of insiders who handle fund assets. The requirements that access persons act jointly in handling fund assets, prepare a written notation of each transaction, and transmit the notation to another designated person are intended to reduce the risk of misappropriation of fund assets by access persons, and to ensure that adequate records are prepared, reviewed by a responsible third person, and available for examination by the Commission. The requirement that auditors verify fund assets without notice twice each year is intended to provide an additional deterrent to the misappropriation of fund assets and to detect any irregularities.
The Commission staff estimates that each fund makes 974 responses and spends an average of 252 hours annually in complying with the rule's requirements.
The estimate of average burden hours is made solely for the purposes of the Paperwork Reduction Act, and is not derived from a comprehensive or even a representative survey or study of the costs of Commission rules and forms. Complying with the collections of information required by rule 17f-2 is mandatory for those funds that maintain custody of their own assets. Responses will not be kept confidential. 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 control number.
The public may view the background documentation for this information collection at the following website,
Pursuant to Section 19(b)(1)
The Exchange proposes to amend the NYSE Proprietary Market Data Fee Schedule (“Fee Schedule”) regarding the NYSE Best Quote and Trades (“BQT”) market data feed. The Exchange proposes to make the fee change effective May 21, 2018. The proposed rule change is available on the Exchange's website 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 amend the Fee Schedule regarding the NYSE BQT market data feed. The NYSE BQT data feed provides best bid and offer and last sale information for the Exchange and its affiliates, NYSE Arca, Inc. (“NYSE Arca”) and NYSE American LLC (“NYSE American”).
The Exchange currently charges an access fee of $250 per month for the NYSE BQT data feed. The Exchange is not proposing any change to the access fee. The purpose of this filing is to amend footnote 5 to the Fee Schedule to provide that to subscribe to NYSE BQT, subscribers must also subscribe to, and pay applicable fees for, NYSE National BBO and NYSE Trades in addition to subscribing to, and paying for, NYSE BBO, NYSE Trades, NYSE Arca BBO, NYSE Arca Trades, NYSE American BBO and NYSE American Trades.
The Exchange believes that the proposed rule change is consistent with the provisions of Section 6 of the Act,
The Exchange further believes that requiring market data recipients to separately subscribe to and pay for the eight underlying data feeds to NYSE BQT is reasonable because by design, NYSE BQT represents an aggregated and consolidated version of those existing eight data feeds. The Exchange notes that it is not seeking with this filing to establish fees relating to the underlying BBO and Trades data feeds, as those fees have already been established consistent with Section 19(b)(3)(A) of the Act
The Exchange further believes that the proposed NYSE BQT fee structure is equitable and not unfairly discriminatory because all vendors and subscribers that elect to purchase NYSE BQT would be subject to the same fees. In addition, vendors and subscribers that do not wish to purchase NYSE BQT may separately purchase the individual underlying data feed, and if they so choose, perform a similar aggregation and consolidation function that the Exchange performs in creating NYSE BQT. To enable such competition, the Exchange would continue to offer NYSE BQT on terms that a subscriber of the underlying feeds could offer a competing product if it so chooses.
The Exchange also notes that the use of NYSE BQT is entirely optional. Firms have a wide variety of alternative market data products from which to choose, including the Exchanges' own underlying data products, and proprietary data products offered by the Exchange's competitors, and consolidated data. Moreover, the Exchange is not required to make any proprietary data products available or to offer any specific pricing alternatives to any customers.
As explained below in the Exchange's Statement on Burden on Competition, the existence of alternatives to these data products further ensures that the Exchange cannot set unreasonable fees, or fees that are unreasonably discriminatory, when vendors and subscribers can elect such alternatives. That is, the Exchange competes with other exchanges (and their affiliates) that provide similar “best quote and trade” market data products. If another exchange (or its affiliate) were to charge less to consolidate and distribute its similar product than the Exchange charges to consolidate and distribute NYSE BQT, prospective users likely would not subscribe to, or would cease subscribing to, NYSE BQT. In addition, the Exchange would compete with unaffiliated market data vendors who would be in a position to consolidate and distribute the same data that comprises the NYSE BQT feed into the vendor's own comparable market data product. If the third-party vendor is able to provide the exact same data for a lower cost, prospective users would avail themselves of that lower cost and elect not to take NYSE BQT.
In accordance with Section 6(b)(8) of the Act,
The market for proprietary data products is competitive and inherently
Moreover, competitive markets for listings, order flow, executions, and transaction reports impose pricing discipline for the inputs of proprietary data products and therefore constrain markets from overpricing proprietary market data. Broker-dealers send their order flow and transaction reports to multiple venues, rather than providing them all to a single venue, which in turn reinforces this competitive constraint. As a 2010 Commission Concept Release noted, the “current market structure can be described as dispersed and complex” with “trading volume . . . dispersed among many highly automated trading centers that compete for order flow in the same stocks” and “trading centers offer[ing] a wide range of services that are designed to attract different types of market participants with varying trading needs.”
If an exchange succeeds in competing for quotations, order flow, and trade executions, then it earns trading revenues and increases the value of its proprietary market data products because they will contain greater quote and trade information. Conversely, if an exchange is less successful in attracting quotes, order flow, and trade executions, then its market data products may be less desirable to customers in light of the diminished content and data products offered by competing venues may become more attractive. Thus, competition for quotations, order flow, and trade executions puts significant pressure on an exchange to maintain both execution and data fees at reasonable levels.
In addition, in the case of products that are also redistributed through market data vendors, such as Bloomberg and Thompson Reuters, the vendors themselves provide additional price discipline for proprietary data products because they control the primary means of access to certain end users. These vendors impose price discipline based upon their business models. For example, vendors that assess a surcharge on data they sell are able to refuse to offer proprietary products that their end users do not or will not purchase in sufficient numbers. Vendors will not elect to make NYSE BQT available unless their customers request it, and customers will not elect to pay for NYSE BQT unless the product can provide value by sufficiently increasing revenues or reducing costs in the customer's business in a manner that will offset the fees. All of these factors operate as constraints on pricing proprietary data products.
No written comments were solicited or received with respect to the proposed rule change.
The foregoing rule change is effective upon filing pursuant to Section 19(b)(3)(A)
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
For the Commission, by the Division of Trading and Markets, pursuant to delegated authority.
The Fixed Income Clearing Corporation (“FICC”) filed with the U.S. Securities and Exchange Commission (“Commission”) on January 12, 2018 proposed rule change SR-FICC-2018-001 (“Proposed Rule Change”) pursuant to Section 19(b)(1) of the Securities Exchange Act of 1934 (“Exchange Act”)
FICC proposes to change the FICC GSD Rulebook (“GSD Rules”)
FICC states that the changes proposed in the Proposed Rule Change are designed to improve GSD's current VaR Charge so that it responds more effectively to market volatility.
For the proposed sensitivity approach to the VaR Charge, FICC would source sensitivity data and relevant historical risk factor time series data generated by an external vendor based on its econometric, risk, and pricing models.
• Key rate measures the sensitivity of a price change to changes in interest rates;
• convexity measures the degree of curvature in the price/yield relationship of key interest rates;
• implied inflation rate measures the difference between the yield on an ordinary bond and the yield on an inflation-indexed bond with the same maturity;
• agency spread is yield spread that is added to a benchmark yield curve to discount an Agency bond's cash flows to match its market price;
• mortgage-backed securities spread is the yield spread that is added to a benchmark yield curve to discount a to-be-announced (“TBA”) security's cash flows to match its market price;
• volatility reflects the implied volatility observed from the swaption market to estimate fluctuations in interest rates;
• mortgage basis captures the basis risk between the prevailing mortgage rate and a blended Treasury rate; and
• time risk factor accounts for the time value change (or carry adjustment) over the assumed liquidation period.
The above-referenced risk factors are similar to the risk factors currently utilized in MBSD's sensitivity approach; however, GSD has included other risk factors that are specific to the U.S. Treasury securities, Agency securities and mortgage-backed securities cleared through GSD.
Additionally, FICC proposes to change the look-back period from a front-weighted one-year look-back to an evenly-weighted 10-year look-back period that would include, to the extent applicable, an additional stressed period. FICC states that the proposed extended look-back period would help to ensure that the historical simulation contains a sufficient number of historical market conditions.
FICC also proposes to look at the historical changes of specific risk factors during the look-back period in order to generate risk scenarios to arrive at the market value changes for a given portfolio.
FICC also proposes to eliminate the augmented volatility adjustment multiplier. FICC states that the multiplier would not be necessary because the proposed sensitivity approach would have a longer look-back period and the ability to include an additional stressed market condition to account for periods of market volatility.
According to FICC, in the event that a portfolio contains classes of securities that do not have sufficient volume and price information available, a historical simulation approach would not generate VaR Charge amounts that reflect the risk profile of such securities.
Finally, FICC proposes to adjust the existing calculation of the VaR Charge to include a VaR Floor, which would be the amount used as the VaR Charge when the sum of the amounts calculated
FICC proposes to add a new component to GSD's margin calculation—the Blackout Period Exposure Adjustment.
FICC proposes to eliminate the existing Blackout Period Exposure Charge component from GSD's margin calculation.
FICC also proposes to eliminate the existing Coverage Charge component from GSD's margin calculation.
FICC proposes to amend GSD's existing Backtesting Charge component of its margin calculation to (1) include the backtesting deficiencies of certain Members during the Blackout Period and (2) give GSD the ability to assess the Backtesting Charge on an intraday basis.
Currently, the Backtesting Charge does not apply to Members with mortgage-backed securities during the Blackout Period because such Members would be subject to a Blackout Period Exposure Charge.
FICC also proposes to adjust the Backtesting Charge to apply to Members that experience backtesting deficiencies during the trading day because of such Member's intraday trading activities.
FICC proposes to adjust GSD's calculation for determining the Excess Capital Premium. Currently, GSD assesses the Excess Capital Premium when a Member's VaR Charge exceeds the Member's Excess Capital.
Separate from the above changes to GSD's margin calculation, FICC proposes to provide transparency in the GSD Rules with respect to GSD's existing calculation of the Intraday Supplemental Fund Deposit.
FICC calculates the Intraday Supplemental Fund Deposit by tracking three criteria for each Member.
The QRM Methodology document provides the methodology by which FICC would calculate the VaR Charge, with the proposed sensitivity approach, as well as other components of the Members' margin calculation.
In Amendment No. 1, FICC proposes three things. First, FICC proposes to stagger the implementation of the proposed Blackout Period Exposure Adjustment and the proposed removal of the Blackout Period Exposure Charge.
Second, FICC proposes to amend the implementation date for the remainder of the proposed changes contained in the Proposed Rule Change.
Third, FICC proposes to correct an incorrect description of the calculation of the Excess Capital Premium that appears once in the narrative to the Proposed Rule Change, as well as in the corresponding location in the Exhibit 1A to the Proposed Rule Change.
Interested persons are invited to submit written data, views and arguments concerning whether Amendment No. 1 is consistent with the Exchange 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.
Section 19(b)(2)(C) of the Exchange Act
Section 17A(b)(3)(F) of the Exchange Act requires, in part, that the rules of a clearing agency be designed to, among other things, assure the safeguarding of securities and funds which are in the custody or control of the clearing agency or for which it is responsible.
The Commission believes that the changes proposed in the Proposed Rule Change, as modified by Amendment No. 1, are designed to assure the safeguarding of securities and funds which are in the custody or control of the clearing agency or for which it is responsible, consistent with Section 17A(b)(3)(F) of the Exchange Act.
Second, as described above, FICC proposes to implement the existing Margin Proxy as a back-up methodology to the proposed sensitivity approach to the VaR Charge calculation. This proposed change would help FICC to better limit its credit exposure to Members by continuing to calculate each Member's VaR Charge in the event that FICC experiences a data disruption with the vendor that supplies the sensitivity data.
Third, as described above, FICC proposes to eliminate the augmented volatility adjustment multiplier from its current VaR Charge calculation. This proposed change would enable FICC to remove a component from the VaR Charge calculation that would no longer be needed on account of the proposed 10-year look-back period that has the option of an additional stress period.
Fourth, as described above, FICC proposes to implement a haircut method for securities with inadequate historical pricing data and, thus, lack sufficient data to generate a historical simulation that adequately reflects the risk profile of such securities under the proposed sensitivity approach to FICC's VaR Charge calculation. Employing a haircut on such securities would help FICC limit its credit exposure to Members that transact in the securities by establishing a way to better capture their risk profile.
Fifth, as described above, FICC proposes to implement a VaR Floor. The proposed VaR Floor would be triggered in the event that the proposed sensitivity VaR model calculates a VaR Charge that is too low because of offsets applied by the model from certain offsetting long and short positions. In other words, the VaR Floor would serve as a backstop to the proposed sensitivity approach to FICC's VaR Charge calculation, which would help ensure that FICC continues to limit its credit exposure to Members. Altogether, these proposed changes to the VaR Charge component of the margin calculation would enable FICC to view and respond more effectively to market volatility by attributing market price moves to various risk factors and more effectively limiting FICC's credit exposure to Members in market conditions that reflect a rapid decrease in market price volatility levels.
In addition to these changes to the VaR Charge component of the margin calculation, FICC proposes to make a number of changes to other components of the margin calculation. Specifically, as described above, FICC proposes to (1) add the Blackout Period Exposure Adjustment component to FICC's margin calculation to help address risks that could result from overstated values of mortgage-backed securities that are pledged as collateral for GCF Repo Transactions during a Blackout Period; (2) make changes to the existing Backtesting Charge component to help ensure that the charge will apply to (i) all Members that experience backtesting deficiencies attributable to the Member's GCF Repo Transactions that are collateralized with mortgage-backed securities during the Blackout Period, and (ii) all Members that experience backtesting deficiencies during the trading day because of such Member's intraday trading activities; (3) provide more detail in the GSD Rules regarding FICC's calculation of the existing Intraday Supplemental Fund Deposit charge and its determination of whether to assess the charge; and (4) remove the Coverage Charge and Blackout Period Exposure Charge components because the risk these components addressed would be addressed by the other proposed changes to the margin calculation, specifically the proposed
In Amendment No. 1, as described above, FICC proposes to (1) stagger the implementation of the proposed Blackout Period Exposure Adjustment and the proposed removal of the Blackout Period Exposure Charge in response to commenters; (2) accelerate the implementation date for the remainder of the proposed changes contained in the Proposed Rule Change, in order address concerns with the existing VaR Charge calculation sooner; and (3) correct an incorrect description of the calculation of the Excess Capital Premium in the originally filed materials.
Taken together, the above mentioned proposed changes to the components of the margin calculation would enhance FICC's current method for calculating each Member's margin. This enhancement, in turn, would enable FICC to produce margin levels more commensurate with the risks associated with its Members' portfolios in a broader range of scenarios and market conditions, and, thus, more effectively cover its credit exposure to its Members. In addition, the Proposed Rule Change is designed to help FICC mitigate losses that Member default could cause to FICC and its non-defaulting Members.
By better limiting FICC's credit exposure to Members, the proposed changes are designed to help ensure that, in the event of a Member default, FICC has collected sufficient margin from the defaulted Member to manage the default, so that non-defaulting Members would not be exposed to mutualized losses as a result of the default. By helping to limit non-defaulting Members' exposure to mutualized losses, the proposal is designed to help assure the safeguarding of securities and funds that are in FICC's custody or control. As such, the Proposed Rule Change, as modified by Amendment No. 1, is designed to help promote the safeguarding of securities and funds in FICC's custody and control. Therefore, the Commission believes that the Proposed Rule Change, as modified by Amendment No. 1, is consistent with Section 17A(b)(3)(F) of the Exchange Act.
Section 17A(b)(3)(I) of the Exchange Act requires that the rules of a clearing agency do not impose any burden on competition not necessary or appropriate in furtherance of the purposes of the Exchange Act.
However, several commenters stated that some, if not all, of the proposed changes would impose an undue burden on competition. Specifically, Ronin states that the proposed sensitivity VaR model requires more margin of its Members than is necessary, and thus, would unduly impose a competitive burden on Members that have higher costs of capital.
Similarly, IDTA states that that the proposed changes would disproportionately result in greater increases in margin for non-Bank Members on a percentage basis and consequently would impose an unnecessary burden on competition.
Two commenters state that not utilizing cross-margining in the GSD margin calculation creates a burden on competition.
Two commenters state that FICC's use of a 10-year look-back period and an additional stressed period in the VaR Charge calculation would impose a burden on competition.
Two commenters state that the proposed Excess Capital Premium charge would impose a burden on competition.
Amherst further states that the Excess Capital Premium calculation would impose an additional competitive burden on broker-dealer Members, as non broker-dealer Member's Excess Capital used in the measurement of any Excess Capital Premium may not be based on net worth after reductions for haircuts or other non-allowable asset deductions similar to broker-dealer Member requirements.
One commenter states that the Blackout Period Exposure Adjustment would result in a burden on competition.
In response to commenters concerns, generally, FICC states that the proposed changes are necessary to ensure that its margin methodology would appropriately address the risks presented by Members' clearing portfolios.
In response to Ronin and IDTA concerns, discussed above, that smaller, non-bank Members would see greater increases in margin as a result of the proposed changes, FICC states that the proposed sensitivity approach is based on a risk factor approach for securities in a Member's portfolio to calculate such Member's VaR Charge.
In response to the commenters concerns, discussed above, regarding the need for utilizing cross-margining in the GSD margin calculation, FICC notes that it operates under two divisions—GSD and MBSD—and each has its own rules and members.
Nevertheless, FICC agrees that data sharing and cross-margining arrangements would be beneficial to its membership.
In response to the commenters concerns, discussed above, suggesting FICC's proposed use of a 10-year look-back period and an additional stressed period in the VaR Charge calculation would be unnecessary and biased, FICC states that the proposed changes to extend the look-back period and add an additional stressed period would help to ensure that the historical simulation contains a sufficient number of historical market conditions (including but not limited to stressed market conditions) that are necessary to calculate margin amounts that achieve a 99 percent confidence level.
In response to the commenters concerns, discussed above, regarding the Excess Capital Premium, FICC states that for a majority of Members, the proposed VaR Charge calculation would be higher than the current VaR Charge calculation excluding the Margin Proxy and that the higher VaR Charge could result in a higher Excess Capital Premium for some Members.
In response to the commenters concerns, discussed above, regarding the Blackout Period Exposure Adjustment, FICC states that the proposed Blackout Period Exposure Adjustment is appropriate at the intraday collection cycle on the last business day of the month to mitigate exposure that begins on the first business day of the following month.
As a general matter, the Commission acknowledges that a proposal to enhance FICC's VaR model, such as this proposal, could entail increased margin charges to some Members that would be borne by those Members and market participants more generally. The Commission understands that the impact of the cost of meeting an increased margin requirement would depend, in part, on each Member's specific business model and that some Members could satisfy the increase at a lower cost than others. As a result, the proposed changes contained in the Proposed Rule Change that would result in an increased margin charge could impose higher costs on some Members relative to others because of those Members' business choices. These higher relative burdens may weaken certain Members' competitive positions relative to other Members. However, as discussed below, the Commission believes that any competitive burden imposed by the proposed changes would not impose any burden on competition not necessary or appropriate in furtherance of the purposes of the Exchange Act.
As discussed above, during the fourth quarter of 2016, FICC's current methodology for calculating the VaR Charge did not respond effectively to the market volatility that existed at that time. As a result, the VaR Charge did not achieve backtesting coverage at a 99 percent confidence level and, therefore, yielded backtesting deficiencies beyond FICC's risk tolerance. To address this
While the proposed changes contained in the Proposed Rule Change may raise the costs that certain Members incur to cover the risks associated with their portfolios, the Commission believes that these costs reflect the risks that these Members present to FICC, as the proposal is tailored to the different risk factors presented by each Member's portfolio, as described above. Specifically, the proposal to (1) move to a sensitivity approach to the VaR Charge calculation would enable the VaR Charge calculation to respond more effectively to market volatility by allowing FICC to attribute market price moves to various risk factors; (2) establish an evenly-weighted 10-year look-back period, with the option to add an additional stress period, would help FICC to ensure that the proposed sensitivity VaR Charge calculation contains a sufficient number of historical market conditions, to include stressed market conditions; (3) use the existing Margin Proxy as a back-up methodology system would help ensure FICC is able to calculate a VaR Charge for Members despite not being able to receive sensitivity data; (4) to implement a haircut method for securities with insufficient sensitivity data would help ensure that FICC is able to capture the risk profile of the securities; (5) establish the VaR Floor would help ensure that FICC assesses a VaR Charge where the proposed sensitivity calculation has produce too low of a VaR Charge; (6) establish the Blackout Period Exposure Adjustment component would enable FICC to address risks that could result from overstated values of mortgage-backed securities that are pledged as collateral for GCF Repo Transactions during a Blackout Period; (7) adjust the existing Backtesting Charge component would enable FICC to ensure that the charge applies to all Members, as appropriate, and to Members intraday trading activities that could pose a risk to FICC in the event that such Members default during the trading day; and (8) eliminate the Blackout Period Exposure Charge, Coverage Charge, and augmented volatility adjustment multiplier components would ensure that FICC did not maintain elements of the prior margin calculation that would unnecessarily increase Members' margin under the proposed margin calculation. Therefore, the Commission believes that each of the above proposed changes is tailored to the different risk factors presented by Members' portfolios. Tailoring the proposed changes to the different risk factors presented would, in turn, help FICC better mitigate the potential losses to FICC and its Members associated with liquidating a Member's portfolio in the event of a Member default. Specifically, such tailoring would help ensure that FICC collects adequate margin to offset the specific risks associated with each Member's portfolio, in furtherance of FICC's obligations under Section 17A(b)(3)(F) of the Exchange Act to safeguard the securities and funds in FICC's custody or control, as discussed above.
In response to commenters' concerns, discussed above, that too much margin would be collected, after reviewing the data provided by FICC in Exhibit 3 to the Proposed Rule Change in conjunction with the Commission's supervisory observations, the Commission believes that the proposed changes would better enable FICC to collect margin commensurate with the different levels of risk that Members pose to FICC. Further, the Commission believes the amount of margin FICC would collect under the proposed changes would help FICC better manage its credit exposures to its Members and those exposures arising from its payment, clearing, and settlement processes. The Commission also believes, having reviewed Exhibit 3 to the Proposed Rule Change, that not all Members' margin requirements would increase as a result of the proposed changes and that the impact of the proposed changes vary based on Members' clearing portfolios and the market volatility that exists at that time. Further, the Commission believes that the proposed changes to the VaR Charge would not necessarily result in higher margin requirements in other components of the margin calculation where the VaR Charge is used in calculating the component. The Commission also notes that FICC proposes to eliminate the augmented volatility adjustment multiplier and Coverage Component because these components would have the effect of unnecessarily increasing margin amounts. Therefore, the Commission is not persuaded by IDTA's generalized statement that the proposed changes would have such a dramatic effect as to limit the diversity of liquidity in the U.S. markets, such as by causing Members to terminate their GSD membership. Rather, the Commission believes that the proposed changes promote a margin methodology that would appropriately address the risks presented by Members' clearing portfolios, enabling FICC to better mitigate losses that a Member default could cause to FICC and its non-defaulting Members.
Commenters expressed concerns, discussed above, that smaller, non-bank Members would be overly burdened by the proposed changes. After reviewing the data provided by FICC in Exhibit 3 to the Proposed Rule Change in conjunction with the Commission's supervisory observations, the Commission believes that the proposed sensitivity approach appropriately calculates a Member's VaR Charge based on risk factors presented by the securities held in a Member's portfolio and, thus, that the impact of the proposed changes would be determined by a Member's portfolio composition rather than a Member “type.” To the extent a Member's VaR Charge would increase under the proposed changes, it would be based on the securities held by the Member and FICC needing to collect margin to appropriately address that risk.
In response to the commenters concerns, discussed above, regarding the need for utilizing cross-margining in
The Commission also notes that certain other actions by FICC may address some of the commenter concerns with respect to cross-margining. For instance, FICC states that it has and will continue to explore data sharing and cross-margining opportunities, and that FICC is in the process of completing a proposal that would enable a margin reduction for Members with MBS positions that offset between GSD and MBSD. FICC has also committed to continuing to develop a framework with CME that will enhance FICC's existing cross-margining arrangement with CME.
In response to the commenters concerns, discussed above, regarding the 10-year look-back period and an additional stressed period in the VaR Charge calculation, the Commission believes that an evenly-weighted 10-year look-back period, plus an additional stress period, as needed, would be an appropriate approach to help ensure that the proposed sensitivity VaR Charge calculation accounts for historical market observations of the securities cleared by GSD. Such a look-back period would help enable FICC to be in a better position to maintain backtesting coverage above 99 percent for GSD. As evidenced in FICC's second comment letter, a 10-year look-back period that includes a stress period would provide backtesting coverage above 99 percent, while a five-year look-back period and a one-year look-back period would not.
In response to the commenters concerns, discussed above, regarding the Excess Capital Premium, the Commission notes that this proposed change would modify the denominator used in the calculation. Specifically, the denominator would become larger, as the proposal to use Net Capital (proposed denominator) is a larger amount than the current use of Excess Net Capital (current denominator).
The Commission notes that under the Proposed Rule Change, FICC is not proposing to amend the numerator, as the numerator used for calculating the Excess Capital Premium would still be calculated using the VaR Charge calculation. Of course, if the numerator in the calculation (
In response to the commenters concerns, discussed above, regarding the calculation of the Blackout Period Exposure Adjustment, the Commission agrees with FICC. Specifically, the Commission agrees that (i) given the number of assumptions that one would need to make with respect to the various factors that influence MBS pay-down rates, the weighted-average approach would provide Members more transparency and certainty around the charge; and (ii) a credit-risk weighting would not likely produce a sufficient charge amount in the event of an actual Member default, as the approach would assume something less than a 100 percent probability of default in calculating the charge. Furthermore, in response to commenters' concerns regarding the Blackout Period Exposure Adjustment collection cycle, the Commission notes the proposed cycle follows the same cycle currently used for the Blackout Period Exposure Charge, which FICC proposes to eliminate on account of the proposed Blackout Period Exposure Adjustment. For both the current and proposed cycle, the Commission understands, based on its experience and expertise, that FICC's application of the charge on the last business day of the month, as opposed to the first business day of the following month, is an appropriate way to ensure that FICC collects the funds before realizing the risk that the charge is intended to mitigate (
Taken together, the Commission believes that the above discussed proposed changes to the components of the margin calculation would enhance FICC's current method for calculating each Member's margin. This enhancement would enable FICC to produce margin levels more commensurate with the risks associated with its Members' portfolios in a broader range of scenarios and market conditions, and, thus, more effectively cover its credit exposure to its Members.
Therefore, for all of the above reasons, Commission believes that the Proposed Rule Change is consistent with Section 17A(b)(3)(I) of the Exchange Act, as the proposal would not impose a burden on competition not necessary or appropriate in furtherance of the purposes of the Exchange Act.
The Commission believes that the changes proposed in the Proposed Rule Change are consistent with Rule 17Ad-22(e)(4)(i) under the Exchange Act. Rule 17Ad-22(e)(4)(i) requires each covered clearing agency
As described above, FICC proposes a number of changes to the way it addresses credit exposure to its Members through its margin calculation. Specifically, FICC proposes to (1) replace its existing full revaluation VaR Charge calculation with a sensitivity approach to the VaR Charge calculation that uses an evenly-weighted 10-year look-back period; (2) utilize the existing Margin Proxy as a back-up VaR Charge calculation to the proposed sensitivity approach in the event that FICC experiences a data disruption with the third-party vendor; (3) implement a haircut method for securities that are ineligible for the sensitivity approach to FICC's VaR Charge calculation due to inadequate historical pricing data; (4) establish the VaR Floor; (5) establish the Blackout Period Exposure Adjustment component; (6) adjust the existing Backtesting Charge component; and (7) use Net Capital instead of Excess Capital when calculating the Excess Capital Premium, as applicable, for broker Members, inter-dealer broker Members, and dealer Members.
Two commenters expressed concerns regarding the proposed change to the Excess Capital Premium.
In response, FICC states that the Excess Capital Premium is used to more effectively manage the risk posed by a Member whose activity causes it to have a margin requirement that is greater than its excess regulatory capital.
Additionally, two commenters noted that the proposed sensitivity approach to the VaR Charge calculation is not needed at this time because the Margin Proxy
In response, FICC states that the Margin Proxy has historically provided a more accurate VaR Charge calculation than the full valuation approach, but the current VaR Charge as supplemented by the Margin Proxy calculation reflects relatively low market price volatility that has been present in the mortgage-backed securities market since the beginning of 2017. As such, FICC states that this current approach contains an insufficient amount of look-back data to ensure that the backtesting will remain above 99 percent if volatility returns to levels seen beyond the one-year look-back period that is currently used to calibrate the Margin Proxy for MBS.
In Amendment No. 1, FICC states that it has been discussing the proposed changes with Members since August 2017 in order to help Members prepare for and understand why FICC proposed
The Commission believes that these proposed changes are designed to help FICC better identify, measure, monitor, and manage its credit exposure to its Members by calculating more precisely the risk presented by Members, which would enable FICC to assess a more reliable VaR Charge. Specifically, FICC's proposed change to (1) switch to a sensitivity approach to the VaR Charge calculation, with a 10-year look-back period, would help the calculation respond more effectively to market volatility by attributing market price moves to various risk factors; (2) use the Margin Proxy as a back-up to the proposed sensitivity calculation would help ensure that FICC is able to assess a VaR Charge, even if its unable to receive sensitivity data from the third-party vendor; (3) apply a haircut on securities that are ineligible for the sensitivity VaR Charge calculation would enable FICC to better account for the risk presented by such securities; (4) establish the VaR Floor would enable FICC to better calculate a VaR Charge for portfolios where the proposed sensitivity approach would yield too low a VaR Charge; (5) establish the Blackout Period Exposure Adjustment component would enable FICC to better address risks that could result from overstated values of mortgage-backed securities that are pledged as collateral for GCF Repo Transactions during a Blackout Period; (6) adjust the existing Backtesting Charge component would ensure that the charge applied to all Members, as appropriate, and to Member's intraday trading activities; and (7) use Net Capital instead of Excess Capital when calculating the Excess Capital Premium would make the Excess Capital Premium calculation for broker Members, inter-dealer broker Members, and dealer Members more consistent with the equity capital measure that is used for other Members.
In response to commenters concerns regarding the proposed change to the Excess Capital Premium calculation, the Commission notes that this proposed change would only modify the denominator used in the calculation. Specifically, the denominator would become larger, as the proposal to use Net Capital (proposed denominator) is a larger amount than the current use of Excess Net Capital (current denominator).
Of course, if the numerator in the calculation (
In response to the comments that the proposed sensitivity approach to the VaR Charge calculation is not necessary at this time in light of the Margin Proxy, the Commission disagrees. In considering these comments, the Commission thoroughly reviewed (i) the Proposed Rule Change, including the supporting exhibits that provided confidential information on the performance of the proposed sensitivity calculation, impact analysis, and backtesting results; (ii) the comments received; and (iii) the Commission's own understanding of the performance of the current VaR Charge calculation, with which the Commission has experience from its general supervision of FICC, compared to the proposed sensitivity calculation. More specifically, the confidential Exhibit 3 submitted by FICC includes (i) 12-month rolling coverage backtesting results; (ii) intraday backtesting impact analysis; (iii) a breakdown of coverage percentages and dollar amounts, for each Member, under the current margin model with and without Margin Proxy and under the proposed sensitivity model; and (iv) an impact study of the proposed changes detailing the margin amounts required per Member during Blackout Periods and non-Blackout Periods.
On a Member basis, the Commission notes that there is not a sizeable change in the amount of margin collected under the current margin model, supplemented by the Margin Proxy, compared to the proposed sensitivity model. The Commission also notes that the Margin Proxy was implemented as a temporary solution to issues identified with the current model, as it only has a one year look-back period.
Therefore, for the reasons discussed above, the Commission believes that the changes proposed in the Proposed Rule Change are consistent with Rule 17Ad-22(e)(4)(i) under the Exchange Act.
The Commission believes that the changes proposed in the Proposed Rule Change are consistent with Rule 17Ad-22(e)(6)(i) under the Exchange Act. Rule 17Ad-22(e)(6)(i) requires each covered clearing agency to establish, implement, maintain and enforce written policies and procedures reasonably designed to cover its credit exposures to its participants by establishing a risk-based margin system that, at a minimum considers, and produces margin levels commensurate with, the risks and particular attributes of each relevant product, portfolio, and market.
As described above, FICC proposes a number of changes to how it calculates Members' margin charge through a risk-based margin system that considers the risks and attributes of securities that GSD clears. Specifically, FICC proposes to (1) move to a sensitivity approach to the VaR Charge calculation; (2) move from a front-weighted one-year look-back period to an evenly-weighted 10-year look-back period with the option for an additional stress period; (3) use the existing Margin Proxy as a back-up methodology to the proposed sensitivity approach to the VaR Charge calculation; (4) implement a haircut method for securities with insufficient sensitivity data due to inadequate historical pricing; (5) establish the VaR Floor; (6) establish the Blackout Period Exposure
Several commenters raised concerns that the proposed changes to the margin calculation would not produce a margin charge commensurate with the risks and particular attributes of Members' complete portfolios. Specifically, Ronin states that the use of the proposed sensitivity approach to the VaR Charge calculation only uses a subset of a Member's entire portfolio (
In response, FICC disagrees with Amherst's statement that FICC's failure to implement a cross-margining arrangement would be inconsistent with the requirements of Rule 17Ad-22(e)(6) under the Exchange Act.
Nevertheless, FICC states that it agrees with commenters that data sharing and cross-margining would be beneficial to its Members and is exploring data sharing and cross-margining opportunities outside of the Proposed Rule Change.
Separate from those comments, two commenters also raised concerns with the proposed extended look-back period. Ronin states that FICC's assumption of adding a continued stress period to the 10-year look-back calculation is employing “statistical bias” because it treats every day as if the market is in “the midst of a financial crisis” and creates over margining.
In response, FICC states that a longer look-back period will produce a more stable VaR estimate that adequately reflects extreme market moves ensuring the VaR Charge does not decrease as quickly during periods of low volatility nor increase as sharply during periods of a market crisis.
The Commission believes that these proposed changes are designed to help FICC better cover its credit exposures to its Members, as the changes would help establish a risk-based margin system that considers and produces margin levels commensurate with the risks and particular attributes of the products cleared in GSD. Specifically, the proposal to (1) move to a sensitivity approach to the VaR Charge calculation would enable the VaR Charge calculation to respond more effectively to market volatility by allowing FICC to attribute market price moves to various risk factors; (2) establish an evenly-weighted 10-year look-back period, with the option to add an additional stress period, would help FICC to ensure that the proposed sensitivity VaR Charge calculation contains a sufficient number of historical market conditions, to include stressed market conditions; (3) use the existing Margin Proxy as a back-up methodology system would help ensure FICC is able to calculate a VaR Charge for Members despite a not being able to receive sensitivity date; (4) to implement a haircut method for securities with insufficient sensitivity data would help ensure that FICC is able to capture the risk profile of the securities; (5) establish the VaR Floor would help ensure that FICC assesses a VaR Charge where the proposed sensitivity calculation has produce too low of a VaR Charge; (6) establish the Blackout Period Exposure Adjustment component would enable FICC to address risks that could result from overstated values of mortgage-backed securities that are pledged as collateral for GCF Repo Transactions during a Blackout Period; (7) adjust the existing Backtesting Charge component would enable FICC to ensure that the charge applies to all Members, as appropriate,
In response to comments regarding cross-margining and its potential impact upon membership levels and market liquidity, the Commission notes that the Proposed Rule Change does not propose to establish or change any cross-margining agreements, whether between GSD and MBSD or between GSD, MBSD, and another clearing agency. As such, cross-margining is not one of the proposed changes under the Commission's review. The Commission further notes that GSD and MBSD have different members (although a member of one could, and some may, apply and become a member of the other), offer different services, and clear different products. To the extent there is the potential to offset risk exposure present across the different products, those products are still cleared by different services. Accordingly, FICC maintains not only separate rulebooks for each division but also separate liquidity resources.
Therefore, the Commission believes that the absence of a proposal in the Proposed Rule Change to establish cross-margining between GSD and MBSD, or to expanding cross-margining between GSD and another clearing agency, does not render the specific changes proposed in the Proposed Rule Change for GSD inconsistent with the Clearing Supervision Act or the applicable rules discussed herein. Rather, the Commission believes that the proposed changes to GSD's margin calculation are designed to be tailored to the specific risks associated with the products and services offered by GSD and that the proposed GSD margin calculation is commensurate with the risks associated with portfolios held by Members in GSD.
In response to comments about the proposed look-back period, the Commission believes that an evenly-weighted 10-year look-back period, plus an additional stress period, as needed, is an appropriate approach to help ensure that the proposed sensitivity VaR Charge calculation accounts for historical market observations of the securities cleared by GSD. Such a look-back period would help enable FICC to be in a better position to maintain backtesting coverage above 99 percent for GSD. As evidenced in FICC's second comment letter, a 10-year look-back period that includes a stress period would provide backtesting coverage above 99 percent, while a five-year look-back period and a one-year look-back period would not.
Therefore, for the above discussed reasons, the Commission believes that the changes proposed in the Proposed Rule Change are consistent with Rule 17Ad-22(e)(6)(i) under the Exchange Act.
The Commission believes that the changes proposed in the Proposed Rule Change are consistent with Rule 17Ad-22(e)(6)(ii) under the Exchange Act. Rule 17Ad-22(e)(6)(ii) requires each covered clearing agency to establish, implement, maintain and enforce written policies and procedures reasonably designed to cover its credit exposures to its participants by establishing a risk-based margin system that, at a minimum, marks participant positions to market and collects margin, including variation margin or equivalent charges if relevant, at least daily and includes the authority and operational capacity to make intraday margin calls in defined circumstances.
As described above, FICC proposes to adjust the existing Backtesting Charge component. Specifically, FICC proposes to collect the charge from all Members on a daily basis, as applicable, as well as from Members that have backtesting deficiencies during the trading day due to large fluctuations of intraday trading activity that could pose risk to FICC in the event that such Members default during the trading day.
The change is designed to help improve FICC's risk-based margin system by authorizing FICC to assess this specific margin charge on all Members at least daily, as needed, and on an intra-day basis, as needed. Therefore, the Commission believes that the changes proposed in the Proposed Rule Change are consistent with Rule 17Ad-22(e)(6)(ii) under the Exchange Act.
The Commission believes that the changes proposed in the Proposed Rule Change are consistent with Rule 17Ad-22(e)(6)(iv) under the Exchange Act. Rule 17Ad-22(e)(6)(iv) requires each covered clearing agency to establish, implement, maintain and enforce written policies and procedures reasonably designed to cover its credit exposures to its participants by establishing a risk-based margin system that, at a minimum, uses reliable sources of timely price data and procedures and sound valuation models for addressing circumstances in which pricing data are not readily available or reliable.
As described above, FICC proposes a number of changes to its margin calculation that are designed to use reliable price data and address circumstances in which pricing data may not be available or reliable. Specifically, FICC proposes to (1) replace its existing full revaluation VaR Charge calculation with the proposed sensitivity approach that relies upon the expertise of a third-party vendor to produce the needed sensitivity data; (2) utilize the existing Margin Proxy as a back-up to the proposed sensitivity VaR Charge calculation in the event that FICC experiences a data disruption with the third-party vendor; (3) implement a haircut method for securities that are ineligible for the proposed sensitivity approach to the VaR Charge calculation due to inadequate historical pricing data; and (4) establish the VaR Floor.
The Commission believes that these proposed changes are designed to help FICC better cover its credit exposures to its Members, as the changes would help establish a risk-based margin system that uses reliable sources of timely price data and procedures and sound valuation models for addressing circumstances in which pricing data are not readily available or reliable. Specifically, the proposal to (1) move to a sensitivity approach to the VaR Charge calculation would not only enable the VaR Charge calculation to respond more effectively to market volatility by allowing FICC to attribute market price moves to various risk factors but also would enable FICC to employ the expertise of a third-party vendor to supply applicable sensitivity data; (2) use the existing Margin Proxy as a back-up methodology system would help ensure FICC is able to calculate a VaR Charge for Members despite any difficulty in receiving sensitivity data from the third-party vendor; (3) implement a haircut method for securities with insufficient sensitivity data would help ensure that FICC is able to capture the risk profile of the securities; and (4) establish the VaR Floor would help ensure that FICC
Therefore, for these reasons, the Commission believes that the changes proposed in the Proposed Rule Change are consistent with Rule 17Ad-22(e)(6)(iv) under the Exchange Act.
The Commission believes that the changes proposed in the Proposed Rule Change are consistent with Rule 17Ad-22(e)(6)(v) under the Exchange Act. Rule 17Ad-22(e)(6)(v) requires each covered clearing agency to establish, implement, maintain and enforce written policies and procedures reasonably designed to use an appropriate method for measuring credit exposure that accounts for relevant product risk factors and portfolio effects across products.
As described above, FICC proposes a number of changes to its margin calculation that are designed to help ensure that FICC accounts for the relevant product risk factors and portfolio effects across GSD's products when measuring its credit exposure to Members. Specifically, FICC proposes to (1) replace its existing full revaluation VaR Charge calculation with the proposed sensitivity approach to the VaR Charge calculation; (2) implement a haircut method for securities that are ineligible for the proposed sensitivity approach due to inadequate historical pricing data; and (3) establish the Blackout Period Exposure Adjustment component.
Two commenters raised concerns regarding the Blackout Period Exposure Adjustment.
Amherst similarly states that using historical pay-down rates for all active MBS pools, rather than using historical pay-down rates for the MBS pools held in each Members' portfolio, in calculating the Blackout Period Exposure Adjustment would eliminate “prudent risk and position management” that Members can undertake to reduce FICC's exposure.
In response, FICC states that Blackout Period Exposure Adjustment collections that occur after the MBS collateral pledge would not mitigate the risk that a Member defaults after the collateral is pledged but before such Member satisfies the next day's margin.
The Commission believes that these proposed changes are designed to help FICC use an appropriate method for measuring credit exposure that accounts for relevant product risk factors and portfolio effects across products cleared by GSD. Specifically, the proposal to (1) move to a sensitivity approach to the VaR Charge calculation would enable the VaR Charge calculation to respond more effectively to market volatility by allowing FICC to attribute market price moves to various risk factors; (2) to implement a haircut method for securities with insufficient sensitivity data would help ensure that FICC is able to capture the risk profile of the securities; and (3) establish the Blackout Period Exposure Adjustment component would enable FICC to address risks that could result from overstated values of mortgage-backed securities that are pledged as collateral for GCF Repo Transactions during a Blackout Period.
In response to commenters' concerns regarding the Blackout Period Exposure Adjustment collection cycle, as stated above, the Commission notes the proposed cycle follows the same cycle currently used for the Blackout Period Exposure Charge, which FICC proposes to eliminate on account of the proposed Blackout Period Exposure Adjustment. For both the current and proposed cycle, the Commission understands, based on its experience and expertise, that FICC's application of the charge on the last business day of the month, as opposed to the first business day of the following month, is an appropriate way to ensure that FICC collects the funds before realizing the risk that the charge is intended to mitigate (
In response to commenters' concerns regarding the calculation of the Blackout Period Exposure Adjustment, the Commission agrees with FICC. Specifically, the Commission agrees that (i) given the number assumptions that
Therefore, for these reasons, the Commission believes that the changes proposed in the Proposed Rule Change are consistent with Rule 17Ad-22(e)(6)(v) under the Exchange Act.
Rule 17Ad-22(e)(6)(vi)(B) under the Exchange Act requires each covered clearing agency to establish, implement, maintain and enforce written policies and procedures reasonably designed to cover its credit exposures to its participants by establishing a risk-based margin system that, at a minimum, is monitored by management on an ongoing basis and is regularly reviewed, tested, and verified by conducting a sensitivity analysis
Some of the commenters raise concerns that two of the presumptions assumed by FICC for backtesting, in order to determine the adequacy of the FICC's margin resources, are inaccurate.
In its response, FICC states that the three-day liquidation period is an accurate assumption of the length of time it would take to liquidate a portfolio given the volume and types of securities that can be found in a Member's portfolio at any given time.
The Commission believes that FICC's assumption that it could take three days to liquidate the portfolio of a defaulted Member, regardless of the size of the portfolio or the type of Member, is appropriate. To the extent there is a difference in the time required for FICC to liquidate various GSD products over a three-day period, the Commission believes that such time is appropriate in order for FICC to focus on the overall risk management of the defaulted Member without creating a liquidation methodology that is overly complex and susceptible to flaws.
Therefore, the Commission believes that the Proposed Rule Change is consistent with Rule 17Ad-22(e)(6)(vi)(B) under the Exchange Act.
Rule 17Ad-22(e)(23)(ii) under the Exchange Act requires each covered clearing agency to establish, implement, maintain and enforce written policies and procedures reasonably designed to provide sufficient information to enable participants to identify and evaluate the risks, fees, and other material costs they incur by participating in the covered clearing agency.
Three commenters expressed concerns regarding the limited time in which Members have had to evaluate the data provided by FICC and the effects of the proposed changes.
Similarly, Amherst states that the proposed changes should not be implemented until Members have had the appropriate time and sufficient information to complete a comparison between the current margin methodology and the proposed changes.
Similarly, Ronin states that FICC has heavily relied on parallel and historical studies when providing its Members
In response, FICC states that its Members have been provided with sufficient time and information to assess the impact of the proposed changes.
In response to commenters, the Commission notes that the disclosure requirements of Rule 17Ad-22(e)(23)(ii) under the Exchange Act
Until the Commission approves the changes proposed in a proposed rule change, disclosure of the proposed changes under Rule 17Ad-22(e)(23)(ii) is not yet applicable, as there would not yet be (and there may not be if the Commission objects to the proposed changes) any risks, fees, or other material costs incurred with respect to the proposed changes. Nevertheless, the Commission notes that FICC has conducted outreach to Members, as described above, and proposes a staggered implementation of the proposed Blackout Period Exposure Adjustment and removal of the Blackout Period Exposure Charge in response to commenters. The Commission believes that the absence of a longer period of time to review the Proposed Rule Change does not render the proposed changes inconsistent with the Clearing Supervision Act or the applicable rules discussed herein.
Therefore, the Commission believes that the changes proposed in the Proposed Rule Change are consistent with Rule 17Ad-22(e)(23)(ii) under the Exchange Act.
The Commission finds good cause to approve the Proposed Rule Change, as modified by Amendment No. 1, prior to the thirtieth day after the date of publication of the notice of Amendment No. 1 in the
The Commission believes that Amendment No. 1 does not raise any novel issues: (i) Staggering the implementation of the proposed Blackout Period Exposure Adjustment is in response to comments received, as described above; (ii) accelerating the implementation date for the remainder of the proposed changes would enable FICC to implement those proposed changes sooner, which, as discussed above, would help FICC address issues identified with its current margin calculation; and (iii) the remaining change is non-substantive. Accordingly, the Commission finds good cause to approve the proposed rule change, as modified by Amendment No. 1, on an accelerated basis, pursuant to Section 19(b)(2) of the Exchange Act.
On the basis of the foregoing, the Commission finds that the Proposed Rule Change, as modified by Amendment No. 1, is consistent with the requirements of the Exchange Act, in particular, with the requirements of Section 17A of the Exchange Act and the rules and regulations thereunder.
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 filed a proposal to amend a representation made in a proposed rule change previously approved by the Commission relating to the listing and trading of the iShares Inflation Hedged Corporate Bond ETF (the “Fund”).
The text of the proposed rule change is available at the Exchange's website 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 parts of such statements.
The shares of the Fund (the “Shares”) were approved for listing and trading on the Exchange under Rule 14.11(i), which governs the listing and trading of Managed Fund Shares.
The Exchange proposes to amend a representation made in the Approval Order such that the representation that limits Fund holdings in Inflation Hedging Instruments
The Exchange is proposing to allow the Fund to hold up to 50% of the weight of its portfolio (including gross notional exposure) in Inflation Hedging Instruments, collectively, in a manner that may not comply with Rules 14.11(i)(4)(C)(iv)(a), 14.11(i)(4)(C)(iv)(b), and/or 14.11(i)(4)(C)(v), as discussed above.
The Exchange is proposing to allow the Fund to hold up to 60% of the weight of its portfolio (including gross notional exposure) in Inflation Hedging Instruments, collectively, in a manner that may not comply with Rules 14.11(i)(4)(C)(iv)(a), 14.11(i)(4)(C)(iv)(b), and/or 14.11(i)(4)(C)(v), as discussed above.
The Exchange believes that this proposed change is a non-controversial change because it is intended only to provide the Adviser with additional flexibility within the Fund's portfolio to hedge inflation risk associated with its exposure to corporate bonds. The Fund's investment objective and investment strategy are not changing. Further to this point, all other representations in the Approval Order that constitute Continued Listing Representations
The Exchange believes that the proposal is consistent with Section 6(b) of the Act
As described above, all of the Continued Listing Representations which formed the basis for the Commission approving the Approval Order remain true and will continue to constitute Continued Listing Representations for the Fund with the exception of the single representation that the Exchange is proposing to amend, which, as amended, will be a Continued Listing Representation for the Fund going forward. This proposed change will only provide the Adviser with additional flexibility within the Fund's portfolio to hedge inflation risk associated with its exposure to corporate bonds. The Fund's investment objective and investment strategy are not changing. As such, the Exchange believes that the proposal does not raise any substantive issues that were not previously addressed in the Approval Order.
Based on the foregoing, the Exchange believes that the proposal is designed to prevent fraudulent and manipulative acts and practices, to promote just and equitable principles of trade, to remove impediments to and perfect the mechanism of a free and open market and a national market system, and, in general, to protect investors and the public interest because there are no substantive issues raised by this proposal that were not otherwise addressed by the Approval Order.
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 that adding the flexibility to fully implement the Fund's hedging strategy will have no impact on competition.
The Exchange has neither solicited nor received written comments on the proposed rule change.
Because the foregoing proposed rule change does not: (i) Significantly affect the protection of investors or the public interest; (ii) impose any significant burden on competition; and (iii) become operative for 30 days from the date on which it was filed, or such shorter time as the Commission may designate, it has become effective pursuant to Section 19(b)(3)(A)(iii) of the Act
A proposed rule change filed pursuant to Rule 19b-4(f)(6) under the Act
The Commission believes that waiving the 30-day operative delay is consistent with the protection of investors and the public interest. The proposal raises no new novel issues. Moreover, as the noted above, apart from increasing the Fund's holdings in Inflation Hedging Instruments to 60% of the weight of its portfolio (including gross notional exposure), all other representations in the Approval Order that constitute Continued Listing Representations for the Fund would remain true and will apply on a continuous basis. Further, the proposed change to the representation above will be a Continued Listing Representation for the Fund going forward. Accordingly, the Commission hereby waives the operative delay and designates the proposal operative upon filing.
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 proposal 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.
U.S. Small Business Administration.
Notice.
This is a notice of an Administrative declaration of a disaster for the Commonwealth of Virginia dated 05/30/2018.
Issued on 05/30/2018.
Submit completed loan applications to: U.S. Small Business Administration, Processing and Disbursement Center, 14925 Kingsport Road, Fort Worth, TX 76155.
A. Escobar, Office of Disaster Assistance, U.S. Small Business Administration, 409 3rd Street SW, Suite 6050, Washington, DC 20416, (202) 205-6734.
Notice is hereby given that as a result of the Administrator's disaster declaration, applications for disaster loans may be filed at the address listed above or other locally announced locations.
The following areas have been determined to be adversely affected by the disaster:
The Interest Rates are:
The number assigned to this disaster for physical damage is 15544C and for economic injury is 155450.
The State which received an EIDL Declaration # is Virginia.
Delmarva Central Railroad Company (DCR), a Class III rail carrier, has filed a verified notice of exemption under 49 CFR 1150.41 to assume operations over an approximately 14.8-mile rail line owned by Canonie Atlantic Co. (CAC) on behalf of the Accomack-Northampton Transportation District Commission (ANTDC) from milepost 30.9 in Pocomoke City, Md., to milepost 45.7 in Hallwood, Va. (the Line).
DCR states that the Line has been operated by Cassatt Management, LLC d/b/a Bay Coast Railroad (BCR).
DCR states that the proposed lease and operation of the Line does not involve any provision or agreement that would limit future interchange with a third-party connecting carrier. DCR certifies that its projected annual revenues from freight operations will not result in the creation of a Class II or Class I rail carrier.
Under 49 CFR 1150.42(b), a change in operators requires that notice be given to shippers. DCR certifies that it has provided notice of the proposed change in operator to the shippers on the Line.
If the verified notice contains false or misleading information, the exemption is void ab initio. Petitions to revoke the exemption under 49 U.S.C. 10502(d) may be filed at any time. The filing of a petition to revoke will not automatically stay the effectiveness of the exemption.
An original and 10 copies of all pleadings, referring to Docket No. FD 36196, must be filed with the Surface Transportation Board, 395 E Street SW, Washington, DC 20423-0001. In addition, a copy of each pleading must be served on DCR's representative, Thomas J. Litwiler, Fletcher & Sippel LLC, 29 North Wacker Drive, Suite 920, Chicago, IL 60606-2832.
According to DCR, this action is excluded from environmental review under 49 CFR 1105.6(c) and from historic preservation reporting requirements under 49 CFR 1105.8(b)(1).
Board decisions and notices are available on our website at
Tennessee Valley Authority.
Record of decision.
This notice is provided in accordance with the Council on Environmental Quality's regulations and Tennessee Valley Authority's (TVA) procedures for implementing the National Environmental Policy Act (NEPA). TVA has decided to construct and operate a bottom ash dewatering facility, process water basins, and an onsite landfill at the Cumberland Fossil Plant (CUF). The notice of availability (NOA) of the Final Environmental Impact Statement (EIS) for the Cumberland Fossil Plant Coal Combustion Residuals Managment Operations was published in the
Ashley Pilakowski, Project Environmental Planning, NEPA Project Manager, Tennessee Valley Authority, 400 W Summit Hill Drive (WT 11D), Knoxville, Tennessee 37902; telephone (865) 632-2256, or by email
TVA is a corporate agency of the United States that provides electricity for business customers and local power distributors serving more than 9 million people in an 80,000 square miles comprised of most of Tennessee and parts of Virginia, North Carolina, Georgia, Alabama, Mississippi, and Kentucky. TVA receives no taxpayer funding, deriving virtually all of its revenues from sales of electricity. In addition to operating and investing its revenues in its power system, TVA provides flood control, navigation and land management for the Tennessee River system and assists local power companies and state and local governments with economic development and job creation.
Built between 1968 and 1973, the two-unit plant at CUF generates enough energy to supply about 1.1 million homes. The plant consumes an average of 5.6 million tons of coal annually and produces nearly 1 million tons of CCR each year. The CCR consist of fly ash, bottom ash, commercial grade gypsum, and solids from the flue gas desulfurization (FGD) process. TVA has managed storage of CCR materials at CUF in a combination of dry stacks and impoundments. Bottom ash generated by the operating units is sluiced to the existing Bottom Ash Impoundment where most of the material settles out. The settled bottom ash is excavated and stacked in the Fly Ash Stack. Water from the Bottom Ash Impoundment flows to the Main Ash Impoundment and Stilling Impoundment before being discharged to the Cumberland River through a permitted outfall. Fly ash is transported in dry form to the Fly Ash Stack. Gypsum is dewatered and conveyed to an adjacent wall-board manufacturer or disposed in the Gypsum Stack or to lined channels where it is dewatered, stockpiled for later use, or disposed in the Gypsum Stack.
The approximately 2,470 megawatts of generating capacity provided by CUF is important in maintaining an adequate and reliable power supply to the north-central portion of TVA's service area. Accordingly, CUF was identified in TVA's 2015 Integrated Resource Plan as one of the coal plants that TVA plans to continue operating in the future. The purpose of the proposed action is to convert the wet storage of CCR to a dry system, to promote the future management of dry CCR at CUF, and to meet the state and federal regulatory requirements for closing ash impoundments including EPA's CCR Rule. The project helps fulfill TVA's goal to convert wet CCR storage to dry and applies to both existing CCR (CCR in the impoundments) and future CCR (dry CCR that would be produced from CUF operations under all of the alternatives). In addition, the dewatering facilities would also foster TVA's compliance with present and future regulatory requirements. This includes the 2015 TDEC Commissioner's Order that requires TVA to evaluate and remediate, if necessary, CCR risks at its plants in Tennessee, except Gallatin. The TDEC Commissioner's Order and other environmental regulatory programs help ensure that CCR management activities at TVA's plants will continue to be protective of human health and the environment.
To enable this wet-to-dry conversion, TVA proposes several projects including: construction and operation of a Bottom Ash Dewatering Facility; closure of the existing ash impoundments; construction and operation of process water basins to handle process wastewater and storm water that previously was routed to the impoundments; and construction and operation of a landfill within the boundaries of TVA owned property on
Based on an extensive analysis of options to manage CCR produced at CUF, TVA considered four alternatives in the Draft EIS and Final EIS. These alternatives are:
Consequently, this alternative would not satisfy the project purpose and need and, therefore, is not considered viable or reasonable. It does, however, provide a benchmark for comparing the environmental impacts of implementation of Alternatives B, C, and D.
1. Construct and operate a Bottom Ash Dewatering Facility at one of two previously disturbed sites proximate to the Main Plant. TVA may construct a recirculation system in a subsequent phase where excess water would be routed back to the plant for future sluicing or other allowed reuse operations. The recirculation system would be contained within the existing facility footprint.
2. Consolidation and Closure-in-Place of the Bottom Ash Impoundment and North Ditch. Closure-by-Removal of a portion of the Main Ash Impoundment and the Stilling Impoundment and repurposing the closed portion as lined Process Water Basin 1 and Process Water Basin 2. To facilitate construction of the lined process water basins, CCR from these areas, plus a foot of underlying soil would be removed and transported to an approved offsite disposal facility. Specifically, approximately 180,000 yd
3. Construct and operate a landfill for disposal of future dry CCR generated at the plant on a site located approximately 1.2 miles southwest of the plant site which is still on CUF property. The selected site encompasses approximately 174 acres with a landfill footprint of approximately 80 acres. The landfill would be built in four major stages with a total estimated capacity of 14.3 million yd
1. Construct and operate a Bottom Ash Dewatering Facility as described for Alternative B.
2. Consolidation and Closure-in-Place of the Bottom Ash Impoundment and North Ditch. Closure-by-Removal of a portion of the Main Ash Impoundment and Stilling Impoundment and repurpose the closed portion as lined Process Water Basin 1 and Process Water Basin 2. The closure of the ash impoundments under this option would be the same as described under Alternative B. However, under this alternative, CCR removed from the ash impoundments would be transported to the existing onsite landfill (Fly Ash Stack) for long-term storage.
3. Construct and operate a landfill for disposal of future dry CCR generated at the plant onsite as described under Alternative B.
1. Construct and operate a Bottom Ash Dewatering Facility as described for Alternative B.
2. The closure of the ash impoundments under this option would be the same as described under Alternative B.
3. Dry CCR produced at CUF would be transported by truck to an offsite landfill, the Bi-County Solid Waste Management Landfill (located approximately 12 miles northeast of CUF) along public roadways. No landfill would be constructed at CUF.
Barge and rail transport were not considered feasible options for this EIS as the facilities at CUF are not configured and designed to support loading and transport of CCR offsite and as such would need to be expanded and improved which could result in environmental impacts and would require additional environmental permitting. In addition, rail and barge facilities are not typical near permitted landfills and are not available at the Bi-County Solid Waste Management Landfill. Therefore, any CCR hauled by barge or rail for landfill disposal would still entail trucking.
The EIS includes baseline information for understanding the potential environmental and socioeconomic impacts associated with the alternatives considered by TVA. TVA considered 21 resource areas related to the human and natural environments and the impacts on these resources associated with each alternative.
Alternative A (No Action) would result in fewer environmental impacts than Alternative B, C and D. However, Alternative A does not meet the purpose and need for the project as continuing current operations would not promote the future management of dry CCR at CUF, and would not meet the state and federal regulatory requirements for closing ash impoundments including EPA's CCR Rule and the TDEC Commissioner's Order. Implementation of Alternative B would result in minimal unmitigated impacts to the environment, most of which would be related to construction activities that would be temporary in nature and minimized with implementation of best management practices. The landfill would change the existing visual integrity which would result in a long-term moderate impact to the viewshed of some members of the surrounding community. Scenic attractiveness may be reduced to minimal in the foreground, but would remain common in the middleground and background. Long-term impacts to streams, aquatic
TVA determined that Alternative C, which avoids the offsite transport of CCR on public roadways would be the environmentally preferable alternative.
On December 5, 2016, TVA published a Notice of Intent (NOI) in the
TVA also hosted an open house public scoping meeting on December 12, 2016, at the Freedom Point Events Center at Liberty Park in Clarksville, Tennessee. Comments received addressed project alternatives, adequacy of impact analysis, groundwater and surface water, aquatic ecology, tiering from the PEIS, and other general topics
The Notice of Availability (NOA) of the Draft EIS was published in the
TVA received 69 comments from 15 commenters. Of the 15 submissions, three were from federal entities, one was from a state entity, one was from a group of environmental advocacy organizations, and 10 were from members of the public. Comments were received in relation to the Draft EIS's sufficiency, compliance with the CCR Rule and TDEC Commissioner's Order, selection of the preferred alternative, groundwater and surface water impacts, local geology, air impacts, solid waste management, and other general topics. TVA provided responses to these comments, made appropriate minor revisions to the Draft EIS, and issued a Final EIS.
The NOA for the Final EIS was published in the
TVA has decided to implement portions of the preferred alternative identified in the Final EIS, Alternative C. This decision includes the construction and operation of a Bottom Ash Dewatering Facility, construction and operation of an onsite landfill, and Closure-by-Removal of a portion of the Main Ash Impoundment and the Stilling Impoundment. The closed area would be repurposed as Process Water Basin 1 and Process Water Basin 2. CCR removed for construction of the basins would be staged temporarily within the Main Ash Impoundment, and TVA will further consider its options before making a decision as to the location for the permanent disposal of the CCR. TVA will issue a decision regarding this and any additional documentation at a future date.
In addition to state and federal water and waste regulations, TVA's CCR disposal areas at CUF, including the impoundments, are subject to the 2015 TDEC Commissioner's Order. Therefore, it is TVA's intention not to pursue Closure-in-Place activities immediately, but rather let the execution of the requirements of the TDEC Commissioner's Order guide the closure activities to the maximum extent possible while complying with the requirements of the CCR Rule. TVA will issue a decision regarding closure of the remaining portion of the Main Ash Impoundment and the Bottom Ash Impoundment and any additional documentation at a future date.
TVA will use appropriate best management practices during all phases of construction and operation of the Bottom Ash Dewatering Facilty, the process water basins and the landfill. Mitigation measures, actions taken to reduce adverse impacts associated with the proposed action, include:
• A TDEC Aquatic Resources Alteration Permit and U.S. Army Corps of Engineers 404 permit will be required for disturbance to wetlands and stream features, and the terms and conditions of these permits would likely require mitigation for these proposed activities. TVA will adhere to all conditions stipulated in these permits.
• TVA will implement supplemental groundwater mitigation measures that could include monitoring, assessment, or corrective action programs as mandated by state and federal requirements. The CCR Rule and state requirements provide an additional layer of groundwater protection to minimize risk.
• TVA will coordinate with the Tennessee Department of Transportation and Stewart County transportation officials as needed to develop appropriate mitigation measures to reduce localized temporary transportation effects.
• Potential impacts to Wells Creek and/or Scott Branch from landfill leachate and storm water discharges will be mitigated as required to meet permit requirements.
• Forested land within the proposed landfill project area is of low summer roosting quality for threatened and endangered bats, although it may be used as a foraging area. Section 7
• TVA executed a memorandum of agreement with the Tennessee State Historic Preservation Officer to address the adverse effects of National Register of Historic Places listed site 40SW219.
Federal Aviation Administration (FAA), DOT.
Notice and request for comments.
In accordance with the Paperwork Reduction Act of 1995, FAA invites public comments about our intention to request the Office of Management and Budget (OMB) approval to reinstate an information collection. The collection involves obtaining basic information from new aviation insurance applicants about eligible aviation insurance applicants needed to establish a legally binding, non-premium insurance policy with the FAA, as requested by another Federal agency, such as the applicants name and address, and the aircraft to be covered by the policy. The information collected will be used to determine whether applicants are eligible for Chapter 443 insurance and the amount of coverage necessary; populate non-premium insurance policies with the legal name and address; and meet conditions of coverage required by each insurance policy.
As a condition of coverage, air carriers will be required to submit any changes to the basic information initially submitted on the application, as necessary. Air carrier's will also be responsible for providing a copy of their current commercial insurance policy on an ongoing basis, and aircraft registration and serial numbers for any new aircraft the air carrier would like to add to the policy. This information will form part of a legally binding agreement (
Written comments should be submitted by August 6, 2018.
Send comments to the FAA at the following address: Barbara Hall, Federal Aviation Administration, ASP-110, 10101 Hillwood Parkway, Fort Worth, TX 76177
Barbara Hall by email at:
The FAA Non-Premium Aviation War Risk Insurance Program offers war risk coverage, without premium, to air carriers at the request of DoD and other Federal agencies. DoD and other Federal agencies rely on the FAA to provide aviation war risk insurance to contracted air carriers supporting mission objectives and operations that is not available commercially on reasonable terms and conditions. Air carriers never insured under the FAA Non-Premium War Risk Insurance Program must submit an application before the FAA can provide coverage.
Federal Aviation Administration (FAA), DOT.
Notice and request for comments.
In accordance with the Paperwork Reduction Act of 1995, FAA invites public comments about our intention to request the Office of Management and Budget (OMB) approval to renew an information collection. The collection involves submittal of pertinent information by a
Written comments should be submitted by August 6, 2018.
Send comments to the FAA at the following address: Barbara Hall, Federal Aviation Administration, ASP-110, 10101 Hillwood Parkway, Fort Worth, TX 76177.
Barbara Hall by email at:
Public Law 103-272 states that all aircraft must be registered before they may be flown. It sets forth registration eligibility requirements and provides for application for registration as well as suspension and/or revocation of registration.
a. Federal Aviation Regulation (FAR) Part 47 prescribes procedures that implement Public Law 103-272 which provides for the issuance of dealer's aircraft registration certificates and for their use in connection with aircraft eligible for registration under this Act by persons engaged in manufacturing, distributing or selling aircraft. Dealer's certificates enable such persons to fly aircraft for sale immediately without having to go through the paperwork and expense of applying for and securing a permanent Certificate of Aircraft Registration. It also provides a system of identification of aircraft dealers.
b. Federal Aviation Regulations (FAR) Part 47 establishes procedures for implementing Section 505 of the Act. Specifically, Subpart C, Parts 47.61 through 47.71, describes procedures for obtaining and using dealer's certificates in FAR Part 47.63, elicit the information needed from the applicant in order to comply with Section 505 of the Act and FAR Part 47, Subpart C.
Federal Aviation Administration (FAA), DOT
Notice and request for comments.
In accordance with the Paperwork Reduction Act of 1995, FAA invites public comments about our intention to request the Office of Management and Budget (OMB) approval to renew an information collection. This collection involves organizations applying to perform certification functions on behalf of the FAA, including approving data and issuing various aircraft and organization certificates.
Written comments should be submitted by August 6, 2018.
Send comments to the FAA at the following address: Barbara Hall, Federal Aviation Administration, ASP-110, 10101 Hillwood Parkway, Fort Worth, TX 76177
Barbara Hall by email at:
Federal Highway Administration (FHWA), U.S. Department of Transportation (DOT).
Notice of public meeting.
FHWA will conduct a series of public meetings to seek input on the integration of automated vehicles on the Nation's roadways that will be held at different locations across the country. The objectives of the public meetings are to: engage with a diverse group of stakeholders to understand key issues regarding automated vehicles and their implications for the roadway infrastructure; and gather input on highway automation to help inform FHWA research, policy, and programs. The public meetings will have presentations and breakout sessions during which participants can provide written and oral comments. This meeting is the first in a series of related public meetings being conducted during 2018.
FHWA will hold the first public meeting on June 7, 2018, in Detroit, Michigan. The meeting will start at 8 a.m. and continue until 2 p.m. EDT. Check-in will begin at 7:30 a.m. Attendees should arrive early enough to check in by 7:50 a.m.
The meeting will be held at the Cobo Center located at 1 Washington Blvd., Detroit, Michigan 48226. This facility is accessible to individuals with disabilities.
If you have questions about the public meeting, please contact John Corbin at
Automated vehicles have the potential to significantly transform the Nation's roadways. They could help save lives, expand access to transportation, and improve the convenience of travel. However, even as these technologies offer new opportunities, they may introduce new challenges for those responsible for the planning, design, construction, operation, and maintenance of the Nation's roadway infrastructure. As a result, FHWA is interested in better understanding the implications of highway automation for its stakeholders and the Agency.
As the effect of automation on the Nation's roadways becomes clearer, FHWA will define its role in further facilitating innovation and enabling the benefits of the capabilities. This National Dialogue on Highway Automation is an opportunity to engage the public and broad stakeholder community to understand their key areas of interest. These stakeholders will include original equipment manufacturers, technology suppliers, transportation network companies, associations, and public-sector partners. The National Dialogue will help inform national research, policy, and implementation assistance activities to support highway automation readiness. This meeting is one in a series of related public meetings being conducted during 2018.
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. The actions relate to a proposed highway project, I-110 High-Occupancy Toll Lane Flyover Project 07-LA-110-PM 20.10/20.92 in the City and County of Los Angeles, 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 23 U.S.C. 139(
For Caltrans: Jason Roach Senior Environmental Planner Chief, Environmental Branch Caltrans, District 7, 100 South Main Street, MS 16A, Los Angeles, CA 90012, Office Hours: 9 a.m.-4:00 p.m., Office Phone: (213) 897-0357, Email:
Effective July 1, 2007, the Federal Highway Administration (FHWA) assigned, and the California Department of
This notice applies to all Federal agency decisions as of the issuance date of this notice and all laws under which such actions were taken, including but not limited to:
(1) Council on Environmental Quality regulations;
(2) National Environmental Policy Act (NEPA);
(3) Moving Ahead for Progress in the 21st Century Act (MAP-21);
(4) Department of Transportation Act of 1966;
(5) Federal Aid Highway Act of 1970;
(6) Clean Air Act Amendments of 1990;
(7) Noise Control Act of 1970;
(8) 23 CFR part 772 FHWA Noise Standards, Policies and Procedures;
(9) Department of Transportation Act of 1966, Section 4(f);
(10) Clean Water Act of 1977 and 1987;
(11) Endangered Species Act of 1973;
(12) Migratory Bird Treaty Act;
(13) National Historic Preservation Act of 1966, as amended;
(14) Historic Sites Act of 1935; and,
(15) Executive Order 13112, Invasive Species.
(16) Title VI of the Civil Rights Act of 1964
23 U.S.C. 139(
Under part 211 of Title 49 Code of Federal Regulations (CFR), this document provides the public notice that on May 25, 2018, the Santa Clara Valley Transportation Authority (SCVTA) and the American Federation of State, County and Municipal Employees (AFSCME) petitioned the Federal Railroad Administration (FRA) for a waiver of compliance from certain provisions of the Federal hours of service laws contained at 49 U.S.C. 21105, which in part prohibit a dispatching service employee from being on duty for more than a total of 9 hours during a 24-hour period. FRA assigned the petition Docket Number FRA-2018-0048.
Specifically, Petitioners seek approval of a pilot project under 49 U.S.C. 21108, which allows railroads and labor organizations to jointly petition for a waiver of compliance from the hours of service laws to enable the establishment of a pilot project. The proposed pilot project would permit a 4-day, 10 hours-per-day work week for the affected employees, “the controllers” on the SCVTA system. Petitioners allege the pilot project will enhance safety of operations due to the increased flexibility in terms of staff assignments and covering unanticipated occurrences on the system, be beneficial to morale, and will provide more flexibility in arranging for ongoing training for employees without having to ask them to sacrifice days off from work.
Petitioners explain that SCVTA is a public agency, with light rail transit operations on three lines, including the Vasona Corridor, which shares a corridor and grade crossings, but not tracks, with Union Pacific Railroad Company (UP). AFSCME is the authorized collective bargaining representative for the controllers, the employees on the SCVTA system that dispatch SCVTA light rail trains. UP train crews contact the SCVTA Operating Control Center prior to operating in the shared corridor, but SCVTA controllers do not otherwise communicate directly with UP train crews, nor do they share a radio frequency with UP.
A copy of the petition, as well as any written communications concerning the petition, is available for review online at
Interested parties are invited to participate in these proceedings by submitting written views, data, or comments. FRA does not anticipate scheduling a public hearing in connection with these proceedings since the facts do not appear to warrant a hearing. If any interested parties desire an opportunity for oral comment and a public hearing, they should notify FRA, in writing, before the end of the comment period and specify the basis for their request.
All communications concerning these proceedings should identify the appropriate docket number and may be submitted by any of the following methods:
•
•
•
•
Communications received by July 23, 2018 will be considered by FRA before final action is taken. Comments received after that date will be considered if practicable.
Anyone can search the electronic form of any written communications and comments received into any of our dockets by the name of the individual submitting the comment (or signing the document, if submitted on behalf of an association, business, labor union, etc.). Under 5 U.S.C. 553(c), DOT solicits comments from the public to better inform its processes. DOT posts these comments, without edit, including any personal information the commenter provides, to
Issued in Washington, DC.
Federal Transit Administration (FTA), DOT.
Notice.
This notice announces final environmental actions taken by the Federal Transit Administration (FTA) for a project extending the METRO Green Line from downtown Minneapolis through the communities of St. Louis Park, Hopkins, Minnetonka, and Eden Prairie, passing near Edina, Minnesota. The purpose of this notice is to announce publicly the environmental decisions by FTA on the subject project and to activate the limitation on any claims that may challenge this final environmental action.
By this notice, FTA is advising the public of final agency actions subject to Section 139(l) of Title 23, United States Code (U.S.C.). A claim seeking judicial review of FTA actions announced herein for the listed public transportation project will be barred unless the claim is filed on or before November 5, 2018.
Nancy-Ellen Zusman, Assistant Chief Counsel, Office of Chief Counsel, (312) 353-2577, or Alan Tabachnick, Environmental Protection Specialist, Office of Environmental Programs, (202) 366-8541. FTA is located at 1200 New Jersey Avenue SE, Washington, DC 20590. Office hours are from 9:00 a.m. to 5:00 p.m., Monday through Friday, except Federal holidays.
Notice is hereby given that FTA has taken final agency action by issuing a certain approval for the public transportation project listed below. The actions on the project, as well as the laws under which such actions were taken, are described in the documentation issued in connection with the project to comply with the National Environmental Policy Act (NEPA) and in other documents in the FTA administrative record for the project. Interested parties may contact either the project sponsor or the FTA Regional Office for more information. Contact information for FTA's Regional Offices may be found at
This notice applies to all FTA decisions on the listed project as of the issuance date of this notice and all laws under which such actions were taken, including NEPA [42 U.S.C. 4321-4375], Section 4(f) requirements [23 U.S.C. 138, 49 U.S.C. 303], Section 106 of the National Historic Preservation Act [16 U.S.C. 470f], and the Clean Air Act [42 U.S.C. 7401-7671q]. This notice does not, however, alter or extend the limitation period for challenges of project decisions subject to previous notices published in the
Pipeline and Hazardous Materials Safety Administration (PHMSA), DOT.
Notice and request for comments.
On March 26, 2018, in accordance with the Paperwork Reduction Act of 1995, the Pipeline and Hazardous Materials Safety Administration (PHMSA) published a notice in the
During the public comment period, PHMSA received no comments in response to the information collections. PHMSA received 10 comments that did not pertain to the information collection requests. PHMSA is publishing this notice to provide the public with an additional 30 days to comment on the renewal of the information collections referenced above and to announce that the information collection requests will be submitted to OMB for approval.
Interested persons are invited to submit comments on or before July 9, 2018 to be assured of consideration.
Angela Dow by telephone at 202-366-1246, by email at
You may submit comments identified by the docket number PHMSA-2018-0021 by any of the following methods:
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•
•
Requests for a copy of the information collections should be directed to Angela
During the 60-day comment period, PHMSA received 10 comments from anonymous submitters that emphasized the general importance of environmental safety in the oil and gas industry.
Section 1320.8(d), Title 5, Code of Federal Regulations, requires PHMSA to provide interested members of the public and affected agencies an opportunity to comment on information collection and recordkeeping requests. This notice identifies three information collection requests that PHMSA will submit to OMB for renewal. The following information is provided for each information collection: (1) Title of the information collection; (2) OMB control number; (3) Current expiration date; (4) Type of request; (5) Abstract of the information collection activity; (6) Description of affected public; (7) Estimate of total annual reporting and recordkeeping burden; and (8) Frequency of collection. PHMSA will request a three-year term of approval for each information collection activity. PHMSA requests comments on the following information collections:
1.
2.
3.
Comments are invited on:
(a) The need for the renewal of these collections of information for the proper performance of the functions of the agency, including whether the information will have practical utility;
(b) 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;
(c) Ways to enhance the quality, utility, and clarity of the information to be collected, and
(d) Ways to minimize the burden of the collection of information on those who are to respond, including the use of appropriate automated, electronic, mechanical, or other technological collection techniques.
The Paperwork Reduction Act of 1995; 44 U.S.C. Chapter 35, as amended; and 49 CFR 1.48.
Office of Foreign Assets Control, Treasury.
Notice.
The U.S. Department of the Treasury's Office of Foreign Assets Control (OFAC) is publishing the names of one or more persons that have been placed on OFAC's Specially Designated Nationals and Blocked Persons List based on OFAC's determination that one or more applicable legal criteria were satisfied. All property and interests in property subject to U.S. jurisdiction of these persons are blocked, and U.S. persons are generally prohibited from engaging in transactions with them.
See
OFAC: Associate Director for Global Targeting, tel.: 202-622-2420; Assistant Director for Sanctions Compliance & Evaluation, tel.: 202-622-2490; Assistant Director for Licensing, tel.: 202-622-2480; or the Department of the Treasury's Office of the General Counsel: Office of the Chief Counsel (Foreign Assets Control), tel.: 202-622-2410.
The Specially Designated Nationals and Blocked Persons List and additional
On May 30, 2018, OFAC determined that the property and interests in property subject to U.S. jurisdiction of the following persons are blocked under the relevant sanctions authorities listed below.
1. MOHTASHAM, Abdolhamid
Designated pursuant to section 1(a)(ii)(C) of Executive Order 13553 of September 28, 2010, “Blocking Property of Certain Persons With Respect to Serious Human Rights Abuses by the Government of Iran and Taking Certain Other Actions” (E.O. 13553), for having acted or purported to act for or on behalf of, directly or indirectly, ANSAR-E HEZBOLLAH, a person determined to be subject to E.O. 13553.
2. OSTAD, Hamid, Iran; DOB 1964 to 1966; Additional Sanctions Information—Subject to Secondary Sanctions; Gender Male (individual) [IRAN-HR] (Linked To: ANSAR-E HEZBOLLAH).
Designated pursuant to section 1(a)(ii)(C) of E.O. 13553 for having acted or purported to act for or on behalf of, directly or indirectly, ANSAR-E HEZBOLLAH, a person determined to be subject to E.O. 13553.
3. ALLAHKARAM, Hossein
Designated pursuant to section 1(a)(ii)(C) of E.O. 13553 for having acted or purported to act for or on behalf of, directly or indirectly, ANSAR-E HEZBOLLAH, a person determined to be subject to E.O. 13553.
4. ALI-ASGARI, Abdulali, Iran; DOB 1958 to 1959; Additional Sanctions Information—Subject to Secondary Sanctions; Gender Male (individual) [IRAN-TRA] (Linked To: ISLAMIC REPUBLIC OF IRAN BROADCASTING).
Designated pursuant to section 3(a)(iii) of Executive Order 13628 of October 9, 2012, “Authorizing the Implementation of Certain Sanctions Set Forth in the Iran Threat Reduction and Syria Human Rights Act of 2012 and Additional Sanctions With Respect to Iran” (E.O. 13628), for having acted or purported to act for or on behalf of, directly or indirectly, ISLAMIC REPUBLIC OF IRAN BROADCASTING, a person determined to be subject to E.O. 13628.
5. FIROUZABADI, Abdolhassan, Iran; DOB 08 Jan 1962; citizen Iran; Additional Sanctions Information—Subject to Secondary Sanctions; Gender Male (individual) [IRAN-TRA].
Designated pursuant to section 3(a)(i) of E.O. 13628 for having engaged in censorship or other activities with respect to Iran on or after June 12, 2009, that prohibit, limit, or penalize the exercise of freedom of expression or assembly by citizens of Iran, or that limit access to print or broadcast media, including the facilitation or support of intentional frequency manipulation by the Government of Iran or an entity owned or controlled by the Government of Iran that would jam or restrict an international signal.
6. KHORAMABADI, Abdolsamad, Iran; DOB 01 Jul 1960; citizen Iran; Additional Sanctions Information—Subject to Secondary Sanctions; Gender Male (individual) [IRAN-TRA].
Designated pursuant to section 3(a)(i) of E.O. 13628 for having engaged in censorship or other activities with respect to Iran on or after June 12, 2009, that prohibit, limit, or penalize the exercise of freedom of expression or assembly by citizens of Iran, or that limit access to print or broadcast media, including the facilitation or support of intentional frequency manipulation by the Government of Iran or an entity owned or controlled by the Government of Iran that would jam or restrict an international signal.
1. ANSAR-E HEZBOLLAH
Designated pursuant to section 1(a)(ii)(A) of E.O. 13553 for being an official of the Government of Iran or a person acting on behalf of the Government of Iran (including members of paramilitary organizations) who is responsible for or complicit in, or responsible for ordering, controlling, or otherwise directing, the commission of serious human rights abuses against persons in Iran or Iranian citizens or residents, or the family members of the foregoing, on or after June 12, 2009, regardless of whether such abuses occurred in Iran.
2. EVIN PRISON, Tehran, Iran; Additional Sanctions Information—Subject to Secondary Sanctions [IRAN-HR].
Designated pursuant to section 1(a)(ii)(A) of E.O. 13553 for being an official of the Government of Iran or a person acting on behalf of the Government of Iran (including members of paramilitary organizations) who is responsible for or complicit in, or responsible for ordering, controlling, or otherwise directing, the commission of serious human rights abuses against persons in Iran or Iranian citizens or residents, or the family members of the foregoing, on or after June 12, 2009, regardless of whether such abuses occurred in Iran.
3. HANISTA PROGRAMING GROUP
Designated pursuant to section 1(a)(ii)(A) of Executive Order 13606 of April 22, 2012, “Blocking the Property and Suspending Entry Into the United States of Certain Persons With Respect to Grave Human Rights Abuses by the Governments of Iran and Syria via Information Technology,” for having operated, or having directed the operation of, information and communications technology that facilitates computer or network disruption, monitoring, or tracking that could assist in or enable serious human rights abuses by or on behalf of the Government of Iran or the Government of Syria.
Additionally, on May 30, 2018, OFAC updated the entries on the Specially Designated Nationals and Blocked Persons List for the following entities, whose property and interests in property subject to U.S. jurisdiction continue to be blocked under the relevant sanctions authorities listed below.
1. AL-BILAD ISLAMIC BANK FOR INVESTMENT AND FINANCE P.S.C. (a.k.a. AL BILAD ISLAMIC BANK), 37 Building El-Karadeh 909 Street 1 Near
Designated on May 15, 2018 pursuant to section 1(c) of Executive Order 13224 of September 23, 2001, “Blocking Property and Prohibiting Transactions With Persons Who Commit, Threaten to Commit, or Support Terrorism,” (E.O. 13224) for being owned or controlled by ARAS HABIB KAREEM, a person determined to be subject to E.O. 13224.
2. AL-NASER AIRLINES (a.k.a. AL NASER WINGS; a.k.a. AL NASER WINGS AIRLINES; a.k.a. ALNASER AIRLINES), Al-Karrada, Babil Region—District 929, St. 21, Home 46, Baghdad, Iraq; P.O. Box 28360, Dubai, United Arab Emirates; P.O. Box 911399, Amman 11191, Jordan; Additional Sanctions Information—Subject to Secondary Sanctions [SDGT] [IFSR] (Linked To: MAHAN AIR).
Designated on May 21, 2015 pursuant to section 1(d)(i) of E.O. 13224 for assisting in, sponsoring, or providing financial, material, technological support for, or financial or other services to or in support of, Iran's MAHAN AIR, a person determined to be subject to E.O. 13224.
3. DART AIRLINES (a.k.a. AIR ALANNA; a.k.a. DART AIRCOMPANY; a.k.a. DART UKRAINIAN AIRLINES; a.k.a. TOVARYSTVO Z OBMEZHENOYU VIDPOVIDALNISTYU 'DART'; a.k.a. “ALANNA”; a.k.a. “ALANNA LLC”; a.k.a. “DART, LLC”; a.k.a. “DART, TOV”), 26a, Narodnogo Opolchenyia Street, Kiev 03151, Ukraine; Kv. 107, Bud. 15/2 Vul.Shuliavska, Kyiv 01054, Ukraine; Ave. Vozdukhoflostsky 90, Kiev 03036, Ukraine; Additional Sanctions Information—Subject to Secondary Sanctions; Tax ID No. 252030326052 (Ukraine); Government Gazette Number 25203037 (Ukraine) [SDGT] [IFSR] (Linked To: CASPIAN AIRLINES).
Designated on September 14, 2017 pursuant to section 1(d)(i) of E.O. 13224 for assisting in, sponsoring, or providing financial, material, technological support for, or financial or other services to or in support of, Iran's CASPIAN AIR, a person determined to be subject to E.O. 13224.
Internal Revenue Service (IRS), Treasury.
Notice of meeting.
The Electronic Tax Administration Advisory Committee (ETAAC) will hold a public meeting on Wednesday, June 27, 2018.
Mr. Michael Deneroff, National Public Liaison, CL:NPL:SRM, Rm. 7559, 1111 Constitution Avenue NW, Washington, DC 20224. Phone: 202-317-6851 (not a toll-free number). Email address:
Notice is hereby given pursuant to section 10(a)(2) of the Federal Advisory Committee Act, 5 U.S.C. App. (1988), that a public meeting of the ETAAC will be held on Wednesday, June 27, 2018 from 9:00 a.m. to 12:00 p.m. at 1111 Constitution Avenue NW, Washington, DC, 20224. The purpose of the ETAAC is to provide continuing advice with regard to the development and implementation of the IRS organizational strategy for electronic tax administration. ETAAC is an organized public forum for discussion of electronic tax administration issues such as prevention of identity theft and refund fraud. It supports the overriding goal that paperless filing should be the preferred and most convenient method of filing tax and information returns. ETAAC members convey the public's perceptions of IRS electronic tax administration activities, offer constructive observations about current or proposed policies, programs and procedures, and suggest improvements. Due to limited seating and security requirements, call or email Michael Deneroff to confirm your attendance. Mr. Deneroff can be reached at 202-317-6851 or
Internal Revenue Service (IRS), Treasury.
Notice of meeting.
An open meeting of the Taxpayer Advocacy Panel Special Projects Committee will be conducted. The Taxpayer Advocacy Panel is soliciting public comments, ideas, and suggestions on improving customer service at the Internal Revenue Service.
The meeting will be held Wednesday, July 18, 2018.
Matthew O'Sullivan at 1-888-912-1227 or (510) 907-5274.
Notice is hereby given pursuant to Section 10(a)(2) of the Federal Advisory Committee Act, 5 U.S.C. App. (1988) that a meeting of the Taxpayer Advocacy Panel Special Projects Committee will be held Wednesday, July 18, 2018, at 2:00 p.m. Eastern Time via teleconference. The public is invited to make oral comments or submit written statements for consideration. Due to limited conference lines,
The agenda will include a discussion on various special topics with IRS processes.
Internal Revenue Service (IRS), Treasury.
Notice of meeting.
An open meeting of the Taxpayer Advocacy Panel Notices and Correspondence Project Committee will be conducted. The Taxpayer Advocacy Panel is soliciting public comments, ideas, and suggestions on improving customer service at the Internal Revenue Service.
The meeting will be held Thursday, July 12, 2018.
Otis Simpson at 1-888-912-1227 or 202-317-3332.
Notice is hereby given pursuant to Section 10(a)(2) of the Federal Advisory Committee Act, 5 U.S.C. App. (1988) that a meeting of the Taxpayer Advocacy Panel Notices and Correspondence Project Committee will be held Thursday, July 12, 2018, at 1:00 p.m. Eastern Time via teleconference. The public is invited to make oral comments or submit written statements for consideration. Due to limited conference lines, notification of intent to participate must be made with Otis Simpson. For more information please contact Otis Simpson at 1-888-912-1227 or 202-317-3332, or write TAP Office, 1111 Constitution Ave. NW, Room 1509, Washington, DC 20224 or contact us at the website:
The agenda will include a discussion on various letters, and other issues related to written communications from the IRS.
Internal Revenue Service (IRS), Treasury.
Notice of meeting.
An open meeting of the Taxpayer Advocacy Panel Toll-Free Phone Line Project Committee will be conducted. The Taxpayer Advocacy Panel is soliciting public comments, ideas, and suggestions on improving customer service at the Internal Revenue Service.
The meeting will be held Tuesday, July 10, 2018.
Rosalind Matherne at 1-888-912-1227 or 202-317-4115.
Notice is hereby given pursuant to Section 10(a)(2) of the Federal Advisory Committee Act, 5 U.S.C. App. (1988) that an open meeting of the Taxpayer Advocacy Panel Toll-Free Phone Line Project Committee will be held Tuesday, July 10, 2018, at 3:00 p.m. Eastern Time via teleconference. The public is invited to make oral comments or submit written statements for consideration. Due to limited conference lines, notification of intent to participate must be made with Rosalind Matherne. For more information please contact Rosalind Matherne at 1-888-912-1227 or 202-317-4115, or write TAP Office, 1111 Constitution Ave. NW, Room 1509, Washington, DC 20224 or contact us at the website:
The committee will be discussing Toll-free issues and public input is welcomed.
Internal Revenue Service (IRS), Treasury.
Notice of meeting.
An open meeting of the Taxpayer Advocacy Panel Tax Forms and Publications Project Committee will be conducted. The Taxpayer Advocacy Panel is soliciting public comments, ideas and suggestions on improving customer service at the Internal Revenue Service.
The meeting will be held Wednesday, July 11, 2018.
Robert Rosalia at 1-888-912-1227 or (718) 834-2203.
Notice is hereby given pursuant to section 10(a)(2) of the Federal Advisory Committee Act, 5 U.S.C. App. (1988) that an open meeting of the Taxpayer Advocacy Panel Tax Forms and Publications Project Committee will be held Wednesday, July 11, 2018, at 2:00 p.m., Eastern Time via teleconference. The public is invited to make oral comments or submit written statements for consideration. Due to limited conference lines, notification of intent to participate must be made with Robert Rosalia. For more information please contact Robert Rosalia at 1-888-912-1227 or (718) 834-2203, or write TAP Office, 2 Metrotech Center, 100 Myrtle Avenue, Brooklyn, NY 11201 or contact us at the website:
Internal Revenue Service (IRS), Treasury.
Notice of meeting.
An open meeting of the Taxpayer Advocacy Panel Taxpayer Communications Project Committee will be conducted. The Taxpayer Advocacy Panel is soliciting public comments, ideas, and suggestions on improving customer service at the Internal Revenue Service.
The meeting will be held Tuesday, July 17, 2018.
Antoinette Ross at 1-888-912-1227 or (202) 317-4110.
Notice is hereby given pursuant to Section 10(a)(2) of the Federal Advisory Committee Act, 5 U.S.C. App. (1988) that an open meeting of the Taxpayer Advocacy Panel Taxpayer Communications Project Committee will be held Tuesday, July 17, 2018, at 2:00 p.m. Eastern Time via teleconference. The public is invited to make oral comments or submit written statements for consideration. Due to limited conference lines, notification of intent to participate must be made with Antoinette Ross. For more information please contact: Antoinette Ross at 1-888-912-1227 or (202) 317-4110, or write TAP Office, 1111 Constitution Avenue NW, Room 1509, National Office, Washington, DC 20224, or contact us at the website:
The committee will be discussing various issues related to Taxpayer Communications and public input is welcome.
Internal Revenue Service (IRS), Treasury.
Notice of meeting.
An open meeting of the Taxpayer Advocacy Panel Joint Committee will be conducted. The Taxpayer Advocacy Panel is soliciting public comments, ideas, and suggestions on improving customer service at the Internal Revenue Service.
The meeting will be held Thursday, July 26, 2018.
Lisa Billups at 1-888-912-1227 or (214) 413-6523.
Notice is hereby given pursuant to Section 10(a)(2) of the Federal Advisory Committee Act, 5 U.S.C. App. (1988) that an open meeting of the Taxpayer Advocacy Panel Joint Committee will be held Thursday, July 26, 2018, at 1:00 p.m. Eastern Time via teleconference. The public is invited to make oral comments or submit written statements for consideration. For more information please contact Lisa Billups at 1-888-912-1227 or (214) 413-6523, or write TAP Office, 1114 Commerce Street, Dallas, TX 75242-1021, or post comments to the website:
The agenda will include various committee issues for submission to the IRS and other TAP related topics. Public input is welcomed.
Internal Revenue Service (IRS), Treasury.
Notice of meeting.
The Taxpayer Advocacy Panel Taxpayer Assistance Center Improvements Project Committee will conduct an open meeting and will solicit public comments, ideas, and suggestions on improving customer service at the Internal Revenue Service.
The meeting will be held Tuesday, July 17, 2018.
Gilbert Martinez at 1-888-912-1227 or (737) 800-4060.
Notice is hereby given pursuant to Section 10(a)(2) of the Federal Advisory Committee Act, 5 U.S.C. App. (1988) that a meeting of the Taxpayer Advocacy Panel Taxpayer Assistance Center Improvements Project Committee will be held Tuesday, July 17, 2018, at 4:00 p.m. Eastern Time. The public is invited to make oral comments or submit written statements for consideration. Due to limited conference lines, notification of intent to participate must be made with Gilbert Martinez. For more information please contact Gilbert Martinez at 1-888-912-1227 or 214-413-6523, or write TAP Office, 3651 S IH-35, STOP 1005 AUSC, Austin, TX 78741, or post comments to the website:
The committee will be discussing various issues related to the Taxpayer Assistance Centers and public input is welcomed.
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 |